253 results on '"Tang, Ghl"'
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2. Characteristics and outcomes of patients with atrial versus ventricular secondary tricuspid regurgitation undergoing tricuspid transcatheter edge-to-edge repair - Results from the TriValve registry
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Russo, G, Badano, L, Adamo, M, Alessandrini, H, Andreas, M, Braun, D, Connelly, K, Denti, P, Estevez-Loureiro, R, Fam, N, Gavazzoni, M, Hahn, R, Harr, C, Hausleiter, J, Himbert, D, Kalbacher, D, Ho, E, Latib, A, Lubos, E, Ludwig, S, Lurz, P, Monivas, V, Nickenig, G, Pedicino, D, Pedrazzini, G, Pozzoli, A, Marafon, D, Pastorino, R, Praz, F, Rodes-Cabau, J, Besler, C, Schofer, J, Scotti, A, Piayda, K, Sievert, H, Tang, G, Thiele, H, Schlotter, F, von Bardeleben, R, Webb, J, Windecker, S, Leon, M, Maisano, F, Metra, M, Taramasso, M, Connelly, KA, Hahn, RT, Marafon, DP, Tang, GHL, von Bardeleben, RS, Russo, G, Badano, L, Adamo, M, Alessandrini, H, Andreas, M, Braun, D, Connelly, K, Denti, P, Estevez-Loureiro, R, Fam, N, Gavazzoni, M, Hahn, R, Harr, C, Hausleiter, J, Himbert, D, Kalbacher, D, Ho, E, Latib, A, Lubos, E, Ludwig, S, Lurz, P, Monivas, V, Nickenig, G, Pedicino, D, Pedrazzini, G, Pozzoli, A, Marafon, D, Pastorino, R, Praz, F, Rodes-Cabau, J, Besler, C, Schofer, J, Scotti, A, Piayda, K, Sievert, H, Tang, G, Thiele, H, Schlotter, F, von Bardeleben, R, Webb, J, Windecker, S, Leon, M, Maisano, F, Metra, M, Taramasso, M, Connelly, KA, Hahn, RT, Marafon, DP, Tang, GHL, and von Bardeleben, RS
- Abstract
Aim Functional or secondary tricuspid regurgitation (STR) is the most common phenotype of tricuspid regurgitation (TR) with atrial STR (ASTR) and ventricular STR (VSTR) being recently identified as two distinct entities. Data on tricuspid transcatheter edge-to-edge repair (T-TEER) in patients with STR according to phenotype (i.e. ASTR vs. VSTR) are lacking. The aim of this study was to assess characteristics and outcomes of patients with ASTR versus VSTR undergoing T-TEER. Methods and results Patients with STR undergoing T-TEER were selected from the Transcatheter Tricuspid Valve Therapies (TriValve) registry. ASTR was defined by (i) left ventricular ejection fraction >= 50%, (ii) atrial fibrillation, and (iii) systolic pulmonary artery pressure <50 mmHg. Patients not matching these criteria were classified as VSTR. Patients with primary TR and cardiac implantable electronic device were excluded. Key endpoints included procedural success and survival at follow-up. A total of 298 patients were enrolled in the study: 65 (22%) with ASTR and 233 (78%) with VSTR. Procedural success was similar in the two groups (80% vs. 83% for ASTR vs. VSTR, p = 0.56) and TEER was effective in reducing TR in both groups (from 97% of patients with baseline TR >= 3+ to 23% in ASTR and to 15% in VSTR, all p = 0.001). At 12-month follow-up, survival was significantly higher in the ASTR versus VSTR cohort (91% vs. 72%, log-rank p = 0.02), with VSTR being an independent predictor of mortality at multivariable analysis (hazard ratio 4.75). Conclusions In a real-world, multicentre registry, T-TEER was effective in reducing TR grade in both ASTR and VSTR. At 12-month follow-up, ASTR showed better survival than VSTR.
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- 2023
3. Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads: Data From the TriValve Registry
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Taramasso M, Gavazzoni M, Pozzoli A, Alessandrini H, Latib A, Attinger-Toller A, Biasco L, Braun D, Brochet E, Connelly KA, de Bruijn S, Denti P, Deuschl F, Estevez-Louriero R, Fam N, Frerker C, Ho E, Juliard JM, Kaple R, Kodali S, Kreidel F, Kuck KH, Lauten A, Lurz J, Monivas V, Mehr M, Nazif T, Nickening G, Pedrazzini G, Praz F, Puri R, Rodes-Cabau J, Schafer U, Schofer J, Sievert H, Tang GHL, Khattab AA, Thiele H, Unterhuber M, Vahanian A, Von Bardeleben RS, Webb JG, Weber M, Windecker S, Winkel M, Zuber M, Hausleiter J, Lurz P, Maisano F, Leon MB, Hahn RT, Taramasso, M, Gavazzoni, M, Pozzoli, A, Alessandrini, H, Latib, A, Attinger-Toller, A, Biasco, L, Braun, D, Brochet, E, Connelly, Ka, de Bruijn, S, Denti, P, Deuschl, F, Estevez-Louriero, R, Fam, N, Frerker, C, Ho, E, Juliard, Jm, Kaple, R, Kodali, S, Kreidel, F, Kuck, Kh, Lauten, A, Lurz, J, Monivas, V, Mehr, M, Nazif, T, Nickening, G, Pedrazzini, G, Praz, F, Puri, R, Rodes-Cabau, J, Schafer, U, Schofer, J, Sievert, H, Tang, Ghl, Khattab, Aa, Thiele, H, Unterhuber, M, Vahanian, A, Von Bardeleben, R, Webb, Jg, Weber, M, Windecker, S, Winkel, M, Zuber, M, Hausleiter, J, Lurz, P, Maisano, F, Leon, Mb, and Hahn, Rt
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Male ,Cardiac Catheterization ,Pacemaker, Artificial ,Time Factors ,Clinical Decision-Making ,Electric Countershock ,Prosthesis Design ,Postoperative Complications ,Risk Factors ,Humans ,Hospital Mortality ,Registries ,610 Medicine & health ,Retrospective Studies ,Aged, 80 and over ,Heart Valve Prosthesis Implantation ,Cardiac Pacing, Artificial ,Hemodynamics ,Mitral Valve Insufficiency ,Recovery of Function ,Defibrillators, Implantable ,Europe ,Treatment Outcome ,Heart Valve Prosthesis ,North America ,Feasibility Studies ,Mitral Valve ,Female - Abstract
OBJECTIVES The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear. BACKGROUND Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis. METHODS The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed. RESULTS Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm2 vs. 0.6 ± 0.3 cm2; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30). CONCLUSIONS TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead.
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- 2019
4. Predictors of Left Ventricular Outflow Tract Obstruction After Transcatheter Mitral Valve Replacement
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Yoon SH, Bleiziffer S, Latib A, Eschenbach L, Ancona M, Vincent F, Kim WK, Unbehaum A, Asami M, Dhoble A, Silaschi M, Frangieh AH, Veulemans V, Tang GHL, Kuwata S, Rampat R, Schmidt T, Patel AJ, Nicz PFG, Nombela-Franco L, Kini A, Kitamura M, Sharma R, Chakravarty T, Hildick-Smith D, Arnold M, de Brito FS, Jr., Jensen C, Jung C, Jilaihawi H, Smalling RW, Maisano F, Kasel AM, Treede H, Kempfert J, Pilgrim T, Kar S, Bapat V, Whisenant BK, Van Belle E, Delgado V, Modine T, Bax JJ, Makkar RR, Yoon, Sh, Bleiziffer, S, Latib, A, Eschenbach, L, Ancona, M, Vincent, F, Kim, Wk, Unbehaum, A, Asami, M, Dhoble, A, Silaschi, M, Frangieh, Ah, Veulemans, V, Tang, Ghl, Kuwata, S, Rampat, R, Schmidt, T, Patel, Aj, Nicz, Pfg, Nombela-Franco, L, Kini, A, Kitamura, M, Sharma, R, Chakravarty, T, Hildick-Smith, D, Arnold, M, de Brito, F, J, R., Jensen, C, Jung, C, Jilaihawi, H, Smalling, Rw, Maisano, F, Kasel, Am, Treede, H, Kempfert, J, Pilgrim, T, Kar, S, Bapat, V, Whisenant, Bk, Van Belle, E, Delgado, V, Modine, T, Bax, Jj, and Makkar, Rr
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- 2019
5. Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification
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Yoon SH, Whisenant BK, Bleiziffer S, Delgado V, Dhoble A, Schofer N, Eschenbach L, Bansal E, Murdoch DJ, Ancona M, Schmidt T, Yzeiraj E, Vincent F, Niikura H, Kim WK, Asami M, Unbehaun A, Hirji S, Fujita B, Silaschi M, Tang GHL, Kuwata S, Wong SC, Frangieh AH, Barker CM, Davies JE, Lauten A, Deuschl F, Nombela-Franco L, Rampat R, Nicz PFG, Masson JB, Wijeysundera HC, Sievert H, Blackman DJ, Gutierrez-Ibanes E, Sugiyama D, Chakravarty T, Hildick-Smith D, de Brito FS, Jr., Jensen C, Jung C, Smalling RW, Arnold M, Redwood S, Kasel AM, Maisano F, Treede H, Ensminger SM, Kar S, Kaneko T, Pilgrim T, Sorajja P, Van Belle E, Prendergast BD, Bapat V, Modine T, Schofer J, Frerker C, Kempfert J, Attizzani GF, Latib A, Schaefer U, Webb JG, Bax JJ, Makkar RR, Yoon, Sh, Whisenant, Bk, Bleiziffer, S, Delgado, V, Dhoble, A, Schofer, N, Eschenbach, L, Bansal, E, Murdoch, Dj, Ancona, M, Schmidt, T, Yzeiraj, E, Vincent, F, Niikura, H, Kim, Wk, Asami, M, Unbehaun, A, Hirji, S, Fujita, B, Silaschi, M, Tang, Ghl, Kuwata, S, Wong, Sc, Frangieh, Ah, Barker, Cm, Davies, Je, Lauten, A, Deuschl, F, Nombela-Franco, L, Rampat, R, Nicz, Pfg, Masson, Jb, Wijeysundera, Hc, Sievert, H, Blackman, Dj, Gutierrez-Ibanes, E, Sugiyama, D, Chakravarty, T, Hildick-Smith, D, de Brito, F, J, R., Jensen, C, Jung, C, Smalling, Rw, Arnold, M, Redwood, S, Kasel, Am, Maisano, F, Treede, H, Ensminger, Sm, Kar, S, Kaneko, T, Pilgrim, T, Sorajja, P, Van Belle, E, Prendergast, Bd, Bapat, V, Modine, T, Schofer, J, Frerker, C, Kempfert, J, Attizzani, Gf, Latib, A, Schaefer, U, Webb, Jg, Bax, Jj, and Makkar, Rr
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- 2019
6. Transcatheter Versus Medical Treatment of Patients With Symptomatic Severe Tricuspid Regurgitation
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Josep Rodés-Cabau, Stephan Windecker, Jeroen J. Bax, Florian Deuschl, Luigi Biasco, Maurizio Taramasso, Eric Brochet, Kim A. Connelly, Michael Mehr, Giovanni Benfari, Alberto Pozzoli, Ryan Kaple, Fabien Praz, Christian Besler, Mirjam Winkel, Christian Frerker, François Philippon, Sabine de Bruijn, Rishi Puri, Alexander Lauten, Ralph Stephan von Bardeleben, Georg Nickening, Azeem Latib, Neil Fam, Alec Vahanian, John G. Webb, Rodrigo Estevez-Loureiro, Horst Sievert, Tamin Nazif, Karl Philipp Rommel, Mara Gavazzoni, Guillem Muntané-Carol, Giovanni Pedrazzini, Philipp Lurz, Felix Kreidel, Adrian Attinger-Toller, Susheel Kodali, Paolo Denti, Vanessa Moñivas, Daniel Braun, Rebecca T. Hahn, Pieter van der Bijl, Jean Michel Juliard, Jörg Hausleiter, Hannes Alessandrini, Maurice Enriquez-Sarano, Karl-Heinz Kuck, Marcel Weber, Michel Zuber, Yan Topilsky, Gilbert H.L. Tang, Holger Thiele, Francesco Maisano, Edwin C. Ho, Martin B. Leon, Victoria Delgado, Joachim Schofer, Ulrich Schäfer, Taramasso, M, Benfari, G, van der Bijl, P, Alessandrini, H, Attinger-Toller, A, Biasco, L, Lurz, P, Braun, D, Brochet, E, Connelly, Ka, de Bruijn, S, Denti, P, Deuschl, F, Estevez-Loureiro, R, Fam, N, Frerker, C, Gavazzoni, M, Hausleiter, J, Ho, E, Juliard, Jm, Kaple, R, Besler, C, Kodali, S, Kreidel, F, Kuck, Kh, Latib, A, Lauten, A, Monivas, V, Mehr, M, Muntane-Carol, G, Nazif, T, Nickening, G, Pedrazzini, G, Philippon, F, Pozzoli, A, Praz, F, Puri, R, Rodes-Cabau, J, Schafer, U, Schofer, J, Sievert, H, Tang, Ghl, Thiele, H, Topilsky, Y, Rommel, Kp, Delgado, V, Vahanian, A, Von Bardeleben, R, Webb, Jg, Weber, M, Windecker, S, Winkel, M, Zuber, M, Leon, Mb, Hahn, Rt, Bax, Jj, Enriquez-Sarano, M, and Maisano, F
- Subjects
Male ,medicine.medical_specialty ,Valve Repaire ,Population ,Tricuspid regurgitation ,030204 cardiovascular system & hematology ,tricuspid valve ,heart valve diseases ,law.invention ,03 medical and health sciences ,Native Valvular Regurgitation ,0302 clinical medicine ,Randomized controlled trial ,law ,tricuspid regurgitation ,Internal medicine ,Tricuspid valve ,medicine ,Clinical endpoint ,Humans ,Registries ,030212 general & internal medicine ,Cardiac Surgical Procedures ,education ,610 Medicine & health ,Aged ,Aged, 80 and over ,education.field_of_study ,business.industry ,Proportional hazards model ,Endovascular Procedures ,Heart valve diseases ,medicine.disease ,Tricuspid Valve Insufficiency ,Europe ,medicine.anatomical_structure ,Echocardiography ,Case-Control Studies ,Heart failure ,North America ,Propensity score matching ,Cohort ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
BACKGROUND Tricuspid regurgitation is associated with increased rates of heart failure (HF) and mortality. Transcatheter tricuspid valve interventions (TTVI) are promising, but the clinical benefit is unknown. OBJECTIVES The purpose of this study was to investigate the potential benefit of TTVI over medical therapy in a propensity score matched population. METHODS The TriValve (Transcatheter Tricuspid Valve Therapies) registry collected 472 patients from 22 European and North American centers who underwent TTVI from 2016 to 2018. A control cohort formed by 2 large retrospective registries enrolling medically managed patients with >= moderate tricuspid regurgitation in Europe and North America (n = 1,179) were propensity score 1:1 matched (distance +/- 0.2 SD) using age, EuroSCORE II, and systolic pulmonary artery pressure. Survival was tested with Cox regression analysis. Primary endpoint was 1-year mortality or HF rehospitalization or the composite. RESULTS After matching, 268 adequately matched pairs of patients were identified. Compared with control subjects, TTVI patients had lower 1-year mortality (23 +/- 3% vs. 36 +/- 3%; p = 0.001), rehospitalization (26 +/- 3% vs. 47 +/- 3%; p < 0.0001), and composite endpoint (32 +/- 4% vs. 49 +/- 3%; p = 0.0003). TTVI was associated with greater survival and freedom from HF rehospitalization (hazard ratio [HR]: 0.60; 95% confidence interval [CI]: 0.46 to 0.79; p = 0.003 unadjusted), which remained significant after adjusting for sex, New York Heart Association functional class, right ventricular dysfunction, and atrial fibrillation (HR: 0.39; 95% CI: 0.26 to 0.59; p < 0.0001) and after further adjustment for mitral regurgitation and pacemaker/defibrillator (HR: 0.35; 95% CI: 0.23 to 0.54; p < 0.0001). CONCLUSIONS In this propensity-matched case-control study, TTVI is associated with greater survival and reduced HF rehospitalization compared with medical therapy alone. Randomized trials should be performed to confirm these results. (C) 2019 by the American College of Cardiology Foundation.
- Published
- 2019
7. Evaluating Mitral TEER in the Management of Moderate Secondary Mitral Regurgitation Among Heart Failure Patients.
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Asgar AW, Tang GHL, Rogers JH, Rottbauer W, Morse MA, Denti P, Mahoney P, Rinaldi MJ, Asch FM, Zamorano JL, Dong M, Huang R, Lindenfeld J, Maisano F, von Bardeleben RS, Kar S, and Rodriguez E
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- Humans, Female, Male, Aged, Prospective Studies, Quality of Life, Ventricular Remodeling physiology, Echocardiography, Transesophageal, Severity of Illness Index, Mitral Valve surgery, Mitral Valve diagnostic imaging, Treatment Outcome, Cardiac Catheterization methods, Aged, 80 and over, Mitral Valve Insufficiency surgery, Heart Failure complications, Heart Failure therapy
- Abstract
Background: Moderate secondary mitral regurgitation (SMR) represents a subgroup of heart failure (HF) patients with treatment restricted to medical therapy. Outcomes in patients with moderate SMR treated with mitral transcatheter edge-to-edge repair (M-TEER) are less well known., Objectives: The aim of this study was to assess the safety and effectiveness of M-TEER in subjects with moderate SMR using the EXPANDed studies., Methods: One-year outcomes in subjects from the EXPANDed studies (EXPAND [A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices] and EXPAND G4 [A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System] MitraClip studies) with baseline moderate SMR (2+), per echocardiographic core laboratory (ECL) assessment, were compared with subjects with baseline severe SMR (≥3+)., Results: There were 335 subjects with moderate SMR and 525 with severe SMR at baseline per ECL review. Baseline characteristics were similar between the 2 subgroups. After treatment with M-TEER, significant MR reduction was achieved in both groups. Significant left ventricular (LV) reverse remodeling was observed through 1 year, with a >20 mL decrease in LV end-diastolic and end-systolic volumes on average in the moderate SMR group. Significant 1-year improvements in NYHA functional class (>78% NYHA functional class I or II) and quality of life (>20 points on the Kansas City Cardiomyopathy Questionnaire-Overall Summary) were observed in subjects with moderate SMR. Similarly, low rates of major adverse events, all-cause mortality, and HF hospitalizations were observed between the 2 subgroups through 1 year., Conclusions: In the EXPANDed studies, subjects with moderate SMR treated with M-TEER had improvements similar to subjects with severe SMR in quality of life and positive LV remodeling at 1 year. Future studies are needed to evaluate if M-TEER would be beneficial for HF patients with moderate SMR., Competing Interests: Funding Support and Author Disclosures The EXPAND (NCT03502811) and EXPAND G4 (NCT04177394) studies were funded and sponsored by Abbott. Dr Asgar is a consultant to Abbott Structural Heart, Medtronic, Edwards LifeSciences, W.L. Gore, and Anteris Technologies. Dr Tang has received speaker honoraria and served as a physician proctor, consultant, advisory board member, TAVR publications committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria and served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve; has served as a consultant and physician screening committee member for Shockwave Medical; has served as a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Rogers is a consultant to Abbott Structural Heart, Biosense Webster, and Boston Scientific. Dr Rottbauer has received consulting fees/speaker honoraria from Abbott, Bayer Healthcare, Boston Scientific, Daiichi Sankyo, Edwards LifeSciences, and Medtronic; and is a member of the steering committee of the EXPAND G4 study for Abbott and Encourage AF study for Daiichi Sankyo. Dr Morse is a consultant for Edwards LifeSciences. Dr Denti has received speaker honoraria from Abbott and Edwards LifeSciences; and has been a consultant to InnovHeart, Artiness, and Pi-Cardia. Dr Mahoney is a consultant and proctor for Medtronic, Edwards LifeSciences, and Boston Scientific; is a consultant for Abbott; and has been awarded research grants from Edwards LifeSciences, Medtronic Abbott, and Boston Scientific. Dr Rinaldi has been awarded honoraria and/or consulting fees from Abbott, Boston Scientific, and Edwards LifeSciences. Dr Asch’s work as an academic core laboratory director is performed through institutional research grants (MedStar Health) with Abbott, Boston Scientific, Medtronic, Edwards LifeSciences, Neovasc, Ancora Heart, LivaNova, MVRx, InnovHeart, Polares Medical, and Aria CV. Dr Zamorano has received speaker honoraria from Pfizer, Amgen, and Daiichi Sankyo; and research grants from Abbott and Edwards LifeSciences. Dr Dong and Ms Huang are employees of Abbott Structural Heart. Dr Lindenfeld has been a consultant for Abbott, Alleviant, AstraZeneca, Biotronik, Boston Scientific, CVRx, Edwards LifeSciences, Merck, Medtronic, V-Wave, Vascular Dynamics, WhiteSwell, and Vectorious; and receives research funding from AstraZeneca. Dr Maisano has received grants and/or institutional research support from Abbott, Medtronic, Edwards LifeSciences, Biotronik, Boston Scientific, NVT, and Terumo; has received honoraria and consulting fees (personal and institutional) from Abbott, Medtronic, Edwards LifeSciences, Xeltis, and Cardiovalve; has received royalty income and intellectual property rights from Edwards LifeSciences; and is a shareholder (including stock options) of CardioGard, Magenta, SwissVortex, Transseptal Solutions, Occlufit, 4Tech, and Perifect. Dr von Bardeleben has performed nonpaid trial activities for Abbott, Edwards LifeSciences, Medtronic, and the University of Göttingen (IIT); and serves as an advisory board or speaker bureau member for Abbott Cardiovascular Edwards LifeSciences, Medtronic, and NeoChord. Dr Kar has received grants and institutional research support from Abbott, Boston Scientific, and Edwards LifeSciences; has received consulting fees/honoraria from Abbott, Boston Scientific, W.L. Gore, and Medtronic; served as a steering committee member of the TRILUMINATE study (Abbott) and as national principal investigator of the EXPAND study and the REPAIR MR study for Abbott. Dr Rodriguez has been awarded grants and support for research from Abbott, Edwards LifeSciences, Boston Scientific, AtriCure, and CardioMech; and has received honoraria or consulting fees from Abbott, Edwards LifeSciences, Philips, Teleflex, and CardioMech., (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2025
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8. Tricuspid Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation: 1-Year Outcomes From the TRILUMINATE Randomized Cohort.
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Tang GHL, Hahn RT, Whisenant BK, Hamid N, Naik H, Makkar RR, Tadros P, Price MJ, Singh GD, Fam NP, Kar S, Mehta SR, Bae R, Sekaran NK, Warner T, Makar M, Zorn G, Benza R, Jorde UP, McCarthy PM, Thourani VH, Ren Q, Trusty PM, Sorajja P, and Adams DH
- Subjects
- Humans, Female, Male, Aged, Treatment Outcome, Quality of Life, Severity of Illness Index, Tricuspid Valve surgery, Aged, 80 and over, Heart Valve Prosthesis Implantation methods, Heart Valve Prosthesis Implantation instrumentation, Follow-Up Studies, Tricuspid Valve Insufficiency surgery, Cardiac Catheterization methods
- Abstract
Background: Tricuspid regurgitation (TR) is a right-sided valvular disease independently associated with morbidity and mortality. The TRILUMINATE Pivotal (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal) is the first randomized controlled trial assessing the impact of TR reduction with tricuspid transcatheter edge-to-edge repair (T-TEER)., Objectives: Outcomes from the full randomized cohort of the TRILUMINATE Pivotal trial have not been previously reported, and the additional enrollment may further support the safety and effectiveness of T-TEER through 1 year., Methods: The TRILUMINATE Pivotal trial is an international randomized controlled trial of T-TEER with the TriClip device in patients with symptomatic, severe TR. Adaptive trial design allowed enrollment past the primary analysis population. The primary outcome was a hierarchical composite of all-cause mortality or tricuspid valve surgery, heart failure hospitalizations (HFHs), and quality-of-life improvement measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1 year., Results: Between August 21, 2019, and June 29, 2022, 572 subjects were randomized, including the primary cohort (n = 350) and subsequent enrollment (n = 222). Subjects were older (78.1 ± 7.8 years) and predominantly female (58.9%), with atrial fibrillation (87.8%) and prior HFH (23.8%). The primary endpoint was met for the full cohort (win ratio = 1.84; P < 0.0001). Freedom from all-cause mortality and tricuspid valve surgery through 12 months was 90.6% and 89.9% for the device and control groups, respectively (P = 0.82). Annualized HFH rate was comparable between device and control subjects (0.17 vs 0.20 events/patient-year; P = 0.40). A significant treatment effect was observed for change in quality of life with 52.3% of device subjects achieving a ≥15-point KCCQ score improvement (compared with 23.5% of control subjects; P < 0.0001). All secondary endpoints favored T-TEER: moderate or less TR at 30 days (88.9% vs 5.3%; P < 0.0001), KCCQ change at 1 year (13.0 ± 1.4 points vs -0.5 ± 1.4 points; P < 0.0001), and 6-minute walk distance change at 1 year (1.7 ± 7.5 m vs -27.4 ± 7.4 m; P < 0.0001). Freedom from major adverse events was 98.9% for T-TEER (vs performance goal: 90%; P < 0.0001)., Conclusions: TriClip was safe and effective in the full randomized cohort of TRILUMINATE Pivotal with significant TR reduction and improvements in 6-minute walk distance and health status. Rates of all-cause mortality or tricuspid valve surgery and HFH through 1 year were not reduced by T-TEER., Competing Interests: Funding Support and Author Disclosures The TRILUMINATE Pivotal trial (NCT03904147) was funded by Abbott. Dr Tang has received speaker honoraria and served as a physician proctor, consultant, advisory board member, TAVR publications committee member, RESTORE study steering committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria and served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve; has served as a consultant and physician screening committee member for Shockwave Medical; has served as a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker's honoraria from Siemens Healthineers. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, Medtronic, Novartis, and Philips Healthcare; and is chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored valve trials, for which she receives no direct industry compensation. Dr Whisenant has received consulting fees from Abbott and Edwards Lifesciences. Dr Hamid has received consulting fees from 4C Medical Technologies, Inc., Alleviant Medical, Inc., AMX, Anteris Technologies Corporation, Edwards Lifesciences, Philips, Valcare Med Ltd, Vdyne, and W. L. Gore & Associates, Inc. Dr Naik has received consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Makkar has received grants and institutional support from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; has received consulting fees from Cordis Corporation and Medtronic; and has unpaid trial activities from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Tadros has received consulting fees from Abbott and Edwards Lifesciences. Dr Price has received consulting fees and honoraria from Abbott, Alleviant, Boston Scientific, Biosense Webster, InnovHeart, Medtronic, Philips Medical, W.L. Gore & Associates, and Shockwave Medical. Dr Singh has served as a consultant and/or on the advisory board for Abbott Structural Heart, Boston Scientific, Siemens Healthcare, and Phillips. Dr Fam has received consulting fees from Abbott. Dr Kar has received consulting fees from Abbott, Boston Scientific, InterShunt, Medtronic, Peija, V wave, W.L. Gore, and Medtronic; and is co-principal investigator of EXPAND (Abbott) and co-principal investigator of REPAIR MR (Abbott). Dr Mehta has received research grants from Abbott and Edwards Lifesciences. Dr Bae has received consulting and speaker fees from Abbott; and is on the clinical endpoint committee and DSMB member for 4C Medical. Dr Makkar is a consultant for Abbott Vascular, Boston Scientific, Edwards Lifesciences, and GE Healthcare. Dr Benza has received consulting fees from Abbott and Bayer HealthCare Pharmaceuticals Inc; and performs consulting and is an endpoint review committee member for United Therapeutics. Dr Jorde has received consulting fees from Abbott and Edwards Lifesciences. Dr McCarthy is a co-principal investigator of Abbott’s REPAIR-MR study (unpaid); is on the advisory board for Abbott and egnite; receives royalties from Edwards Lifesciences; and has received speaker fees from Medtronic, Edwards Lifesciences, and Atricure. Dr Thourani has received research grants from and is an advisor for Edwards Lifesciences. Drs Ren and Trusty are employees of Abbott Structural Heart. Dr Sorajja is co-principal investigator for the TRILUMINATE Pivotal trial; serves on the advisory board for Anteris and VDyne; and has received consulting fees from Boston Scientific, Edwards Lifesciences, Evolution Medical, Medtronic, Shifamed, TriFlo, and W.L. Gore & Associates, Inc. Dr Adams is co-principal investigator for the TRILUMINATE Pivotal trial and receives royalties from Edward Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2025
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9. Impact of Valve Sizing and Positioning on Expansion and Hemodynamics in Redo TAVR With SAPIEN 3.
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Travieso A, Zaid S, Nørgaard BL, Bunc M, Jilaihawi H, Bapat VN, Tang GHL, and De Backer O
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- 2025
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10. Tricuspid Transcatheter Edge-to-Edge Repair in Patients With Transvalvular CIED Leads: The TRILUMINATE Pivotal Trial.
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Naik H, Price MJ, Kapadia S, Whisenant BK, Tadros P, Makkar R, Asgar AW, Fam N, Tang GHL, Mehta SR, Byrne T, Singh G, Panaich SS, Peterman K, Trusty PM, Hamid N, Hahn RT, Adams DH, and Sorajja P
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Background: Patients with tricuspid regurgitation (TR) frequently have transvalvular cardiac implantable electronic device (CIEDs)., Objectives: The aim of this study was to determine the safety and efficacy of tricuspid transcatheter edge-to-edge repair in patients with transvalvular CIED leads., Methods: The TRILUMINATE (Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System) Pivotal Trial (NCT03904147) is an international randomized, controlled trial in symptomatic subjects with severe TR. Subjects with CIED leads were screened by an eligibility committee prior to inclusion into the randomized or single-arm cohorts. Safety events were adjudicated by an independent review committee. All echocardiograms were analyzed by an independent core laboratory., Results: A total of 98 subjects (of 469) with attempted TriClip procedures had transvalvular CIED leads. CIED+ subjects were older (80.2 ± 8.6 years vs 78.2 ± 7.6 years; P = 0.02), with a higher prevalence of renal disease (46.9% vs 31.5%; P = 0.004) and lower health status (Kansas City Cardiomyopathy Questionnaire overall summary score 51.9 ± 21.0 vs 55.0 ± 23.1) at baseline compared with CIED- subjects. Slightly fewer clips were implanted in CIED+ subjects (mean 1.9) than in CIED- subjects (mean 2.2) (P = 0.0018). Procedural times were significantly shorter in CIED+ subjects (132.9 ± 63.3 minutes vs 155.9 ± 71.9 minutes; P = 0.0043) although greater in those with lead-induced TR (149.5 ± 87.5 minutes). Major adverse events (1.0% vs 1.1%) and major bleeding (3.1% vs 3.0%) were infrequent in CIED+ and CIED- subjects. At 30 days, TR reduction to moderate or less was similar in CIED+ and CIED- subjects (88% vs 87%) and was sustained out to 1 year in the majority of subjects (81% vs 84%). Compared with baseline, Kansas City Cardiomyopathy Questionnaire overall summary score significantly improved through 1 year in CIED+ subjects (18.7 ± 22.6; P < 0.0001) and CIED- subjects (16.8 ± 22.6; P < 0.0001). Heart failure symptoms were reduced in both groups at 30 days, with 85% of CIED+ subjects and 87% of CIED- subjects in NYHA functional class I or II. There were no differences in mortality, heart failure hospitalization, and need for tricuspid valve surgery or intervention between groups. No lead revisions, removals, or replacements were reported through follow-up., Conclusions: Tricuspid transcatheter edge-to-edge repair with the TriClip system was safe and effective in selected CIED+ subjects and did not affect CIED function. CIED+ subjects experienced similar TR reduction and quality-of-life improvements as CIED- subjects. Future work should define the treatable scope of patients with transvalvular CIED leads. (TRILUMINATE Pivotal Trial; NCT03904147)., Competing Interests: Funding Support and Author Disclosures This study was funded by Abbott (NCT03904147). Dr Naik has received consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Price has received consulting fees and honoraria from Abbott, Alleviant, Boston Scientific, Biosense Webster, InnovHeart, Medtronic, Philips Medical, W.L. Gore & Associates, and Shockwave Medical. Dr. Whisenant has received consulting fees from Abbott and Edwards Lifesciences. Dr Tadros has received consulting fees from Abbott and Edwards Lifesciences. Dr Makkar has received grants and institutional support from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; has received consulting fees from Cordis and Medtronic; and has conducted unpaid trial activities for Abbott, Boston Scientific, and Edwards Lifesciences. Dr Asgar is a consultant to Abbott Structural Heart, Medtronic, Edwards Lifesciences, W.L. Gore & Associates, and Anteris Technologies. Dr Fam has received consulting fees from Abbott. Dr Tang has received speaker’s honoraria from and has served as a physician proctor, a consultant, an advisory board member, a transcatheter aortic valve replacement publications committee member, an APOLLO trial screening committee member, and an IMPACT MR steering committee member for Medtronic; has received speaker honoraria from and served as a physician proctor, a consultant, an advisory board member, and at TRILUMINATE trial anatomical eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve; has served as a consultant and physician screening committee member for Shockwave Medical; has served as a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Mehta has received research grants form Abbott and Edwards Lifesciences. Dr Byrne has received proctor fees and honoraria from Medtronic and Abbott. Dr Singh has served as a consultant and/or on the advisory board for Abbott Structural Heart, Boston Scientific, Siemens Healthcare, and Phillips. Dr Panaich is a consultant for Abbott, Edwards Lifesciences, and Boston Scientific. Ms Peterman and Dr Trusty are salaried employees of Abbott. Dr Hamid has received consulting fees from 4C Medical Technologies, Alleviant Medical, AMX, Anteris Technologies, Edwards Lifesciences, Philips, Valcare Med, V-Dyne, and W.L. Gore & Associates. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Anteris Technologies, Boston Scientific, Edwards Lifesciences, Medtronic, Novartis, and Philips Healthcare; and is chief scientific officer for the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored valve trials, for which she receives no direct industry compensation. Dr Sorajja is co–principal investigator for the TRILUMINATE Pivotal Trial; serves on the advisory board for Anteris and V-Dyne; and has received consulting fees from Boston Scientific, Edwards Lifesciences, Evolution Medical, Medtronic, Shifamed, TriFlo, and W.L. Gore & Associates. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025. Published by Elsevier Inc.)
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- 2025
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11. In Vivo Frame Geometry of the Navitor Intra-Annular Self-Expanding Valve: A First-in-Human CT Analysis.
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Tang GHL, Kobari Y, Vinayak M, Krishnamoorthy P, Safi LM, Lerakis S, Dangas GD, Kini AS, De Backer O, and Khera S
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- 2025
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12. Clinical Characteristics and Outcomes of Patients Undergoing 3 Aortic Valve Interventions: The THIRD Multicenter Registry.
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Tarantini G, Tang GHL, Pilgrim T, Kim WK, Greenbaum A, Castriota F, Webb JG, Nombela Franco L, De Backer O, Hartikainen T, Codner P, Koren O, Patel V, Meier D, Tomii D, Ueyama HA, Paredes-Vázquez JG, Arturi F, Kornowski R, Makkar RR, Cardaioli F, and Nai Fovino L
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- Humans, Female, Male, Treatment Outcome, Aged, Retrospective Studies, Risk Factors, Time Factors, Aged, 80 and over, Middle Aged, Europe, Aortic Valve Stenosis surgery, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis physiopathology, Aortic Valve Stenosis mortality, Bioprosthesis, Postoperative Complications etiology, Risk Assessment, Registries, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement instrumentation, Transcatheter Aortic Valve Replacement mortality, Aortic Valve surgery, Aortic Valve diagnostic imaging, Aortic Valve physiopathology, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation mortality
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Background: Lifetime treatment of aortic valve disease is a matter of increasing debate. Although the risks of a second aortic valve intervention are recognized, little attention has been given to the challenges of a third., Objectives: This study delves into the clinical characteristics, indications, and outcomes of patients undergoing 3 aortic valve interventions., Methods: The THIRD (THree aortIc Reinterventions for valve Disease) registry is a retrospective multicenter, international study of patients who underwent a third procedure on the aortic valve, either surgically or transcatheter-based. Patients undergoing 2 aortic procedures during the same hospital admission were excluded. Baseline characteristics, timing, and mode of bioprosthetic failure, sequence of the procedures, and clinical outcomes were adjudicated according to the Valve Academic Research Consortium criteria., Results: A total of 51 patients from 11 centers were enrolled in this study. Median follow-up time was 565 (314-1,560) days. Eighteen patients (35%) underwent surgical aortic valve replacement (SAVR), and 33 of 51 patients (65%) underwent transcatheter aortic valve replacement (TAVR) as the third intervention. Mean age was 69 ± 14 years, 20 of 51 patients (39%) were female. STS score was 5.0% (Q1-Q3: 3.3%-7.0%). In all TAVR cases, the indication for the first intervention was severe aortic stenosis, as was the indication in 31 of 45 (69%) of SAVR cases (33% bicuspid). The most prevalent procedure sequence was SAVR-SAVR-TAVR (19/51, 37%), followed by SAVR-SAVR-SAVR (10/51, 20%) and SAVR-TAVR-TAVR (10/51, 20%). TAVR-TAVR-TAVR was performed in 4 of 51 cases (8%). The primary indications for a third intervention included structural valve deterioration (SVD) (39/51, 76%), non-SVD (8/51, 16%), and endocarditis (2/51, 4%). Excluding patients with a mechanical prosthesis, predictors of SAVR as third intervention included a lower STS score (OR: 0.58; 95% CI: 0.34-0.98; P = 0.04) and the presence of moderate or severe prosthesis-patient mismatch (OR: 44.8; 95% CI: 2.41-122.00; P = 0.01). Thirty-day device success was 85% for TAVR and 94% for SAVR., Conclusions: In the THIRD registry, SVD emerged as the predominant indication for a third aortic valve procedure. The most frequent procedure sequence was SAVR-SAVR-TAVR, whereas TAVR-TAVR-TAVR was less common. Although the short-term outcomes in our selected cohort were favorable, further investigation is needed., Competing Interests: Funding Support and Author Disclosures Dr Tarantini has received honoraria for lectures/consulting from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, GADA. Dr Tang is a physician proctor, consultant, and advisory board member for Medtronic; is a consultant and advisory board member for Abbott Structural Heart; is an advisory board member for Boston Scientific and JenaValve; and has received speaker honoraria from Siemens Healthineers. Dr Kim has received personal fees from Abbott, Boston Scientific, Edwards Lifesciences, HI-D Imaging, Meril Life Sciences, and Shockwave Medical. Dr Pilgrim has received research, travel or educational grants to the institution without personal remuneration from Biotronik, Boston Scientific, Edwards Lifesciences, and ATSens; and has received speaker fees and consultancy fees to the institution from Biotronik, Boston Scientific, Edwards Lifesciences, Abbott, Medtronic, Biosensors, and Highlife. Dr Greenbaum has received institutional research support from Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, JenaValve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical; has received consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic; and has an equity interest in Transmural Systems. Dr Webb is a consultant for Edwards Lifesciences; and has received research funding from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Makkar is a consultant for and received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr Franco is a proctor for Abbott Vascular and Edwards Lifesciences. Dr De Backer has received institutional research grants and consulting fees from Boston Scientific. Dr Fovino received consulting fees from Edwards Lifesciences and research grant from Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2025
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13. Mitral transcatheter-edge-to-edge-repair after failed Alfieri stitch: an effective alternative to re-do surgery.
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Passaniti G, Krishnamoorthy PM, Samtani RR, Ratanapo S, Kini AS, Tang GHL, and Safi LM
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- 2025
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14. Redo transcatheter aortic valve replacement in a young patient with congenital aortic valve disease.
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Tanner R, Prandi FR, Tang GHL, El-Hamamsy I, Love BA, Safi LM, Sharma SK, Lerakis S, and Kini AS
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- 2025
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15. Structural Heart Imaging Using 3-Dimensional Intracardiac Echocardiography: JACC: Cardiovascular Imaging Position Statement.
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Tang GHL, Zaid S, Hahn RT, Aggarwal V, Alkhouli M, Aman E, Berti S, Chandrashekhar YS, Chadderdon SM, D'Agostino A, Fam NP, Ho EC, Kliger C, Kodali SK, Krishnamoorthy P, Latib A, Lerakis S, Lim DS, Mahadevan VS, Nair DG, Narula J, O'Gara PT, Packer DL, Praz F, Rogers JH, Ruf TF, Sanchez CE, Sharma A, Singh GD, van Mieghem NM, Vannan MA, Yadav PK, Ya'Qoub L, Zahr FE, and von Bardeleben RS
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- Humans, Cardiac Catheterization instrumentation, Heart Diseases diagnostic imaging, Consensus, Workflow, Image Interpretation, Computer-Assisted, Echocardiography, Three-Dimensional standards, Predictive Value of Tests, Ultrasonography, Interventional standards
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3-dimensional (3D) intracardiac echocardiography (ICE) is emerging as a promising complement and potential alternative to transesophageal echocardiography for imaging guidance in structural heart interventions. To establish standardized practices, our multidisciplinary expert position statement serves as a comprehensive guide for the appropriate indications and utilization of 3D-ICE in various structural heart procedures. The paper covers essential aspects such as the fundamentals of 3D-ICE imaging, basic views, and workflow recommendations specifically tailored for ICE-guided structural heart procedures, such as transeptal puncture, device closure of intracardiac structures, and transcatheter mitral and tricuspid valve interventions. Current challenges, future directions, and training requirements to ensure operator proficiency are also discussed, thereby promoting the safety and efficacy of this innovative imaging modality to support expanding its future clinical applications., Competing Interests: Funding Support and Author Disclosures Dr Tang has received speaker honoraria and served as a physician proctor, consultant, advisory board member, transcatheter aortic valve replacement publications committee member, APOLLO (Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation) trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria and served as a physician proctor, consultant, advisory board member, and the TRILUMINATE (Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation) anatomical eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and Jena-Valve; has served as a consultant for NeoChord, Shockwave Medical, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Hahn has received speaker fees from Abbott Vascular, Edwards Lifesciences, and Philips Healthcare; and has institutional consulting contracts (for which she has received no direct compensation) with Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis. Dr Alkhouli has served as a consultant to Boston Scientific and Abbott. Dr Aman has served on the advisory board for Abbott Structural Heart, as a consultant for Abbott Structural Heart and Philips, and on the speaker bureau for Abbott Structural Heart and Philips. Dr Berti has been a proctor for Abbott, St. Jude, and Edwards. Dr Chadderdon has received consulting fees from Medtronic and Edwards Lifesciences; and has received grant support from Medtronic and GE Healthcare. Dr Fam has been a consultant to Edwards Lifesciences, Abbott, and Cardiovalve. Dr Ho has served as a consultant for NeoChord. Dr Kliger has been a consultant and has received speaker honoraria from Edwards Lifesciences, Medtronic, and Siemens. Dr Kodali has received consultant fees from Admedus and Dura Biotech; holds equity in Dura Biotech, Microinterventional Devices, Thubrikar Aortic Valve, Supira, Admedus, TriFlo, and Anona; and has received institutional grant support from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr Latib has served on advisory boards or as a consultant for Medtronic, Boston Scientific, Edwards Lifesciences, Abbott, and VDyne. Dr Mahadevan has been a consultant for Edwards Lifesciences. Dr Nair has served as a consultant for and receives honoraria for speaking engagements from Boston Scientific, Johnson and Johnson, and Medtronic. Dr Packer has received research funding from Abbott, Biosense Webster, Boston Scientific/EPT, CardioInsight, EBAmed, Medtronic, NeuCures, Siemens, St. Jude Medical, Thermedical, National Institutes of Health, Robertson Foundation, Vital Project Funds, Xenter, and the Mr and Mrs J. Michael Cook Fund. Dr Praz has received travel expenses from Abbott Vascular, Edwards Lifesciences, and Polares Medical. Dr Rogers has been a consultant for Abbott Structural Heart and Boston Scientific. Dr Ruf has received speaker, consulting, and proctoring fees from Abbott Laboratories and Edwards Lifesciences. Dr Singh has been a consultant for Abbott Structural Heart and Philips. Dr van Mieghem has received research grant support from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Biotronik, Daiichi Sankyo, Abiomed, and PulseCath BV. Dr Vannan has received research grants and speaker honoraria from Piedmont Heart Institute for Abbott, Medtronic, Edwards Lifesciences, Philips, Siemens Healthineers, and GE Healthcare. Dr Yadav has been a consultant and speaker for Edwards Lifesciences, Abbott, Dasi Simulations, and Shockwave Medical. Dr Zahr has received institutional grant support from Edwards Lifesciences and Medtronic. Dr von Bardeleben has been a consultant, advisory board member, TRILUMINATE trial eligibility committee member, and speaker for Abbott Vascular and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2025
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16. Management of acute decompensated valvular heart disease.
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Lüsebrink E, Lanz H, Kellnar A, Karam N, Kapadia S, Makkar R, Abraham WT, Latib A, Leon M, Sannino A, Shuvy M, Guerrero M, Fam N, Butler J, Adamo M, Rudolph V, Tang GHL, Stocker TJ, Rommel KP, Lurz P, Thiele H, Massberg S, Praz F, Prendergast B, and Hausleiter J
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Worldwide, valvular heart disease (VHD) is a common cause of hospitalization for acute heart failure. In acute heart failure caused by VHD, symptoms result from rapid haemodynamic changes and subsequent decline in cardiac function, and if left untreated, leads to acute decompensation and cardiogenic shock. Current evidence remains scarce and recommendations regarding the management of acute heart failure caused by VHD are lacking in most recent international guidelines. Herein, we review the management of acute heart failure caused by VHD with a focus on transcatheter therapies and describe currently available evidence based on a systematic literature search on the following valve pathologies: (i) aortic stenosis, (ii) aortic regurgitation, (iii) mitral regurgitation, and (iv) mitral stenosis. Articles reporting outcomes following urgent or emergent valve intervention in the setting of cardiogenic shock or acute heart failure were considered. After screening a total of 2234 articles, 76 published between 1994 and 2023 were included in subsequent analysis. Based on available evidence, proposed treatment algorithms to guide optimal management of acute heart failure caused by VHD were created. As the number of patients presenting with acute heart failure caused by VHD continues to rise and outcomes following transcatheter valve interventions continue to improve, it is inevitable that minimally invasive options will play an increasingly important role in the acute setting, especially given these patients are at an increased operative risk. This review aims to present an organized approach to the complex management and interventional treatment of patients with acute heart failure caused by VHD., (© 2024 European Society of Cardiology.)
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- 2024
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17. Transcatheter Edge-to-Edge Repair in Patients With Complex Tricuspid Valve Anatomy.
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Adams DH, Tang GHL, Whisenant BK, Kodali SK, Singh GD, Fam NP, Kar S, Price MJ, Spies C, Schwartz JG, Makkar RR, Tadros P, Asgar AW, Jorde UP, Benza RL, Thourani VH, McCarthy PM, Bae R, Smith TWR, Lim DS, Makar MM, Naik H, Latib MA, Sitges M, von Bardeleben RS, Lurz P, Hamid N, Hahn RT, and Sorajja P
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- Humans, Female, Male, Aged, Treatment Outcome, Aged, 80 and over, Time Factors, Severity of Illness Index, Risk Factors, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation mortality, Heart Valve Prosthesis, Prosthesis Design, United States, Europe, Hemodynamics, Prospective Studies, Tricuspid Valve physiopathology, Tricuspid Valve surgery, Tricuspid Valve diagnostic imaging, Tricuspid Valve Insufficiency physiopathology, Tricuspid Valve Insufficiency surgery, Tricuspid Valve Insufficiency diagnostic imaging, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects, Cardiac Catheterization mortality, Recovery of Function, Quality of Life
- Abstract
Background: Untreated severe tricuspid regurgitation (TR) carries a poor prognosis., Objectives: The authors report the 1-year outcomes of transcatheter edge-to-edge repair (TEER) with the TriClip system (Abbott Structural Heart) in patients with complex tricuspid valve anatomies., Methods: The multicenter, international TRILUMINATE Pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal) trial included a single-arm cohort, with complex tricuspid valve anatomies excluded from the randomized arm (ie, anticipated TR reduction but not to moderate or less after TEER). The primary outcome endpoint of the single arm was 1-year survival with a Kansas City Cardiomyopathy Questionnaire score improvement ≥10 points., Results: In the primary analysis population (N = 100), the mean age was 80 ± 6 years, and 35% had a cardiac implantable electronic device lead. Nearly 90% of patients had massive or torrential TR, 44% had prior left-sided valve interventions, 63% had ≥4-segmental tricuspid leaflet morphology, and the coaptation gap averaged 7.4 ± 2.7 mm. The primary endpoint was met (outcome: 46.2%, performance goal: 30%; P = 0.0008). A total of 81% of subjects had moderate or less TR at 1 year. No major adverse events or deaths occurred within 30 days postprocedure. One-year all-cause mortality and heart failure hospitalization were 15% and 24%, respectively. Significant improvements in NYHA functional class and Kansas City Cardiomyopathy Questionnaire overall scores occurred and were maintained at 1 year., Conclusions: In patients with complex tricuspid anatomies, TEER with the TriClip system demonstrated excellent procedural safety with significant TR reduction and associated improvements in quality of life at 1 year., Competing Interests: Funding Support and Author Disclosures The TRILUMINATE Pivotal study is sponsored by Abbott. Dr Adams serves as the national co–principal investigator for the Abbott TRILUMINATE U.S. Pivotal Trial, the Medtronic APOLLO FDA Pivotal Trial, and the CoreValve U.S. Pivotal Trial; and The Icahn School of Medicine at Mount Sinai receives royalty payments from Edwards Lifesciences and Medtronic for intellectual property related to the development of valve repair rings. Dr Tang has received consultant and/or speaker honoraria from Abbott Vascular, EastEnd Medical, Medtronic USA, Inc, NeoChord, and Siemens; and serves as a physician advisory board member for JenaValve. Dr Whisenant has received consultant honoraria from Abbott Vascular and Edwards Lifesciences. Dr Kodali has received consultant honoraria from Abbott Vascular, Claret Medical, and Merrill LifeScience; and serves as an advisory board member for Biotrace Medical, MID, and Thubrikar Aortic Valve Inc. Dr Singh has received consultant honoraria from Abbott Vascular. Dr Fam has received consultant honoraria from Abbott Canada, Edwards Lifesciences, and Venus MedTech. Dr Kar serves as the national co–principal investigator of the REPAIR-MR trial; serves a member of the TRILUMINATE Steering Committee; has received consultant honoraria from Abbott Vascular, Boston Scientific, InterShunt, Medtronic USA Inc, Peija, V wave, W. L. Gore & Associates Inc; and is an executive committee member for the V wave trial. Dr Price has received reimbursement from Scripps Health for patient enrollment; and has received consultant honoraria from Abbott Vascular, Biotronik Inc, Boston Scientific, Medtronic, Philips, ShockWave Medical Inc, and W. L. Gore & Associates Inc. Dr Schwartz has received consultant honoraria from Abbott Vascular, Boston Scientific, Cordis, Edwards Lifesciences, Medtronic USA Inc, and Philips Electronics North America. Dr Makkar has received consultant honoraria and/or travel support from Abbott Vascular, Boston Scientific, Cordis Corporation, Edwards Lifesciences, and Medtronic USA Inc; and serves as the VP of Cardiovascular Innovation and Intervention and the Director of Interventional Cardiology and Cardiac Cath Lab at Cedars-Sinai Medical Center. Dr Tadros has received consultant honoraria from Edwards Lifesciences. Dr Asgar has received consulting honoraria from Abbott, Medtronic, Edwards Lifesciences, Teleflex, and W. L. Gore & Associates Inc. Dr Jorde has received consultant honoraria from Abbott and Edwards Lifesciences. Dr Benza has received consultant honoraria from Abbott, Bayer HealthCare Pharmaceuticals Inc, and United Therapeutics. Dr Thourani has received consultant honoraria from Abbott Vascular; and serves as an advisor or researcher for Artivion, AtriCure, Abbott Vascular, Boston Scientific, Edwards Lifesciences, JenaValve, and Shockwave. Dr McCarthy has received royalties and speaker fees from Edwards Lifesciences; and serves on the advisory board and as an unpaid principal investigator for Abbott Laboratories. Dr Bae has received consulting/speaker honoraria from Abbott Structural. Dr Smith serves as a consultant for Abbot Vascular, Laminar, Novo Nordisk, and W. L. Gore & Associates Inc. Dr Lim has received consultant fees/honoraria from Ancora, Dinova Medtech, Valgen, Venus, W. L. Gore & Associates Inc; and is a co-investigator in Abbott COAPT, REPAIR-MR and TRILUMINATE, Edwards CLASP IID/F, and Medtronic APOLLO clinical trials. Dr Makar has received consultant honoraria from Abbott Vascular and Boston Scientific. Dr Naik has received consultant honoraria from Abbott Laboratories, Boston Scientific, and Edwards Lifesciences. Dr Latib serves as a consultant and/or advisory board member for Abbott, Medtronic, Boston Scientific, Edwards Lifesciences, Shifamed, NeoChord, Philips, and VDyne. Dr Sitges has received speaker honoraria and consultant fees for Abbott, Edwards Lifesciences, Medtronic, General Electric, and Siemens. Dr von Bardeleben has performed nonpaid trial activities for Abbott, Edwards Lifesciences, Medtronic, Heart Valve Society (unpaid), EU SHD Coalition (unpaid), and the University of Göttingen (IIT); and serves as an advisory board member or Speakers Bureau member for Abbott Cardiovascular, Edwards Lifesciences, Medtronic, and NeoChord. Dr Lurz has received institutional grants from Abbott Vascular (for patient recruitment), Edwards Lifesciences, and ReCor; has received honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor, and Boehringer Ingelheim; and has stock options with Innoventric. Dr Hamid has received consultant honoraria from 4C Medical Technologies, Inc, Alleviant Medical Inc, AMX, Anteris Technologies Corporation, Edwards Lifesciences, Philips, Valcare Med Ltd, Vdyne, and W. L. Gore & Associates Inc. Dr Hahn has received speaker honoraria from Abbott Vascular, Baylis Medical Company Inc, Edwards Lifesciences, Medtronic USA Inc, and Philips; and serves as Director of Interventional Echocardiography at Columbia University. Dr Sorajja serves as the national co–principal investigator for the Abbott Triluminate US Clinical trial and the clinical trial principal investigator for HighLife; has received consultant honoraria from Boston Scientific, Edwards Lifesciences, Evolution Medical, Medtronic, Shifamed, TriFlo, and W. L. Gore & Associates Inc; and is an advisory board member for Anteris and VDyne., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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18. Transcatheter heart valve explantation for transcatheter aortic valve replacement failure: A Heart Valve Collaboratory expert consensus document on operative techniques.
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Kaneko T, Bapat VN, Alakhtar AM, Zaid S, George I, Grubb KJ, Harrington K, Pirelli L, Atkins M, Desai ND, Bleiziffer S, Noack T, Modine T, Denti P, Kempfert J, Ruge H, Vitanova K, Falk V, Thourani VH, Bavaria JE, Reardon MJ, Mack MJ, Borger MA, Leon MB, Tang GHL, and Fukuhara S
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Competing Interests: Conflict of Interest Statement Dr Kaneko is on the advisory board for Edwards Lifesciences, Abbott, and Johnson and Johnson and serves as a consultant for Medtronic. Dr Bapat is a consultant for Medtronic, Edwards Lifesciences, 4C Medical, and Boston Scientific. Dr George is a consultant for WL Gore, Vdyne, CardioMech, MitreMedical, and Atricure. Dr Grubb is a consultant for Medtronic, Abbott, 4C Medical, Boston Scientific, OpSens, Ancora, and Edwards Lifesciences. Dr Desai has received institution research funding and speaker fees from Gore and Medtronic. Dr Modine is a physician proctor and consultant for Medtronic, Edwards Lifesciences, and Abbott. Dr Denti has received speakers’ honoraria from Abbott and Edwards Lifesciences and is a consultant for InnovHeart. Dr Kempfert has served as a proctor to Boston Scientific. Dr Ruge is a member of the advisory board of Abbott and a physician proctor for Abbott and Edwards Lifesciences. Dr Thourani has received grants from Edwards Lifesciences; consulting fees from Atricure, Abbott, Boston Scientific, Artivion, Shockwave, and Edwards Lifesciences; and holds equity in Dasi Simulations. Dr Bavaria is a consultant to Edwards Lifesciences and Abbott. Dr Reardon is a consultant for Medtronic, Boston Scientific, Abbott, and W. L. Gore & Associates. Dr Mack is coprimary investigator for the PARTNER trial for Edwards Lifesciences and the COAPT trial for Abbott and served as study chair for the APOLLO trial for Medtronic. Dr Borger receives speakers honoraria and or consulting fees on his behalf from Edwards Lifesciences, Medtronic, Abbott and CryoLife. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards, JenaValve, and Medtronic and has received stock options (equity) for advisory board participation in Valve Medical, Picardia, and Venus MedTech. Dr Tang is a physician proctor, consultant, and advisory board member for Medtronic, a consultant and physician advisory board member for Abbott Structural Heart, and a physician advisory board member for Boston Scientific and JenaValve. Dr Fukuhara is a consultant for Terumo Aortic. This work was done under the auspices of the Heart Valve Collaboratory. All other authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest.
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- 2025
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19. 1-Year Real-World Outcomes of TAVR With the Fifth-Generation Balloon-Expandable Valve in the United States.
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Kini AS, Tang GHL, Yaryura R, Petrossian G, Roberts DK, Rahman A, Saltzman A, Durkin R, DeVries JT, and Stinis C
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Background: Longer term outcomes of transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra RESILIA (S3UR) valve over its predecessors have not been reported in a national registry., Objectives: The aim of this study was to compare the 1-year clinical and echocardiographic outcomes of the S3UR with those of the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry., Methods: From September 2022 to March 2023, patients who underwent native TAVR with the S3UR or the S3 or S3U valve were propensity matched and compared. Predictors of 1-year outcomes were identified. The median follow-up time was 358 days (Q1-Q3: 47-365 days) for the S3UR and 364 days (Q1-Q3: 80-365 days) for the S3 and S3U., Results: A total of 4,598 S3UR patients were propensity matched with 4,598 and 32,536 S3 and S3U patients. At discharge, effective orifice areas were larger in the S3UR group (P < 0.0001). The lower discharge mean gradient in the S3UR group was maintained at 30 days and 1 year (P < 0.0001 for all). At 1 year, all-cause mortality (7.6% vs 9.7%; HR: 0.8; 95% CI: 0.67-0.93; P = 0.004), mild or greater paravalvular leak (PVL) (15.6% vs 18.5%; HR: 0.82; 95% CI: 0.69-0.97; P = 0.02), and life-threatening bleeding (2.0% vs 2.7%; HR: 0.7; 95% CI: 0.54-0.94; P = 0.03) were lower in the S3UR group. S3UR and mild or greater PVL were predictive of 1-year mortality in the overall cohort and in low-risk patients. Valve reintervention remained rare at 1 year (0.6% vs 0.4%; HR: 1.46; 95% CI: 0.77-2.78; P = 0.25)., Conclusions: TAVR with the S3UR is associated with superior 1-year clinical outcomes and lower gradients than its predecessors, with less PVL and low valve reintervention. Longer follow-up will determine the durability of the RESILIA technology in the SAPIEN valve platform., Competing Interests: Funding Support and Author Disclosures No grants, contracts, or other forms of financial support were used for this study. As this analysis was restricted to the Edwards Lifesciences S3, S3U, and S3UR transcatheter heart valves, statistical analyses were performed by Edwards Lifesciences. Dr Tang has received speaker honoraria from and has served as a physician proctor, consultant, advisory board member, TAVR publications committee member, RESTORE study steering committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria from and served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve; has served as a consultant and physician screening committee member for Shockwave Medical, NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Stinis has received consulting fees from Edwards Lifesciences, Boston Scientific, Shockwave Medical, and Medtronic; and has served on an advisory board for Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. The views or opinions presented here do not represent those of the American College of Cardiology, STS, or the TVT Registry., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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20. Redo-TAVI with the SAPIEN 3 valve in degenerated calcified CoreValve/Evolut explants.
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Meier D, Nigade A, Lai A, Dorman K, Gill H, Javani S, Akodad M, Wood DA, Rogers T, Puri R, Allen KB, Chhatriwalla AK, Reardon MJ, Tang GHL, Bapat VN, Webb JG, Fukuhara S, and Sellers SL
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- Humans, Calcinosis surgery, Calcinosis physiopathology, Prosthesis Design, Female, Aged, Prosthesis Failure, Male, Treatment Outcome, Transcatheter Aortic Valve Replacement instrumentation, Transcatheter Aortic Valve Replacement methods, Heart Valve Prosthesis, Aortic Valve surgery, Aortic Valve diagnostic imaging, Aortic Valve physiopathology, Aortic Valve pathology, Aortic Valve Stenosis surgery, Aortic Valve Stenosis physiopathology
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Background: Redo-transcatheter aortic valve implantation (TAVI) is the treatment of choice for failed transcatheter aortic valves. Currently, implantation of a SAPIEN 3 (S3) is indicated for redo-TAVI in degenerated CoreValve/Evolut (CV/EV) transcatheter aortic valves (TAVs) but is not well understood., Aims: We aimed to evaluate S3 function following implantation in explanted calcified CV/EV TAVs and to assess the impact of CV/EV pathology on redo-TAVI outcomes., Methods: Ex vivo hydrodynamic testing was performed per the International Organization for Standardization (ISO) 5840-3 standard on 4 S3 TAVs implanted at node 5 in calcified CV/EV explants. The mean gradient (MG), effective orifice area (EOA), peak velocity, regurgitant fraction (RF), geometric orifice area (GOA), leaflet overhang, leaflet pinwheeling, neoskirt height, and frame deformation were evaluated., Results: CV/EV explants were calcified and stenotic. Following S3 implantation, the MG and peak velocity decreased. As per the ISO standard, all S3 implants showed adequate EOA, and 3 out of 4 had an RF within the accepted value (<20%). CV/EV leaflet overhang ranged from 25-37%. Calcified leaflets remained stationary throughout the cardiac cycle (difference <9%) and were not pinned in a manner that constrained S3 systolic flow or appeared to prevent selective frame cannulation. The downstream CV/EV GOA was larger than the upstream S3 GOA during systole. S3 frame underexpansion was seen, resulting in leaflet pinwheeling (range 13-30%). Above the neoskirt, calcium protrusion was observed in contact with the S3 leaflets., Conclusions: S3 implantation at node 5 in calcified CV/EV valves resulted in satisfactory hydrodynamic performance in most configurations tested with stable leaflet overhang throughout the cardiac cycle. The long-term implications of S3 underexpansion, leaflet pinwheeling, and calcium protrusion require future studies.
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- 2024
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21. Redo-TAVI feasibility and coronary accessibility following index TAVI with the Evolut valve in patients with bicuspid aortic valve stenosis.
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Arslani K, Tirado-Conte G, Van Mieghem NM, Mylotte D, Tang GHL, Bapat VN, Leroux L, Tchétché D, Grubb KJ, and De Backer O
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- 2024
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22. Feasibility of redo-TAVI in the self-expanding ACURATE neo2 valve: a computed tomography study.
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Bieliauskas G, Kobari Y, Khokhar AA, Abdel-Wahab M, Abdelhafez A, Fukui M, Kofoed KF, Dudek D, Fuchs A, Cavalcante J, Hayashida K, Tang GHL, Mylotte D, Bapat VN, and Backer O
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- Humans, Female, Male, Aged, Aged, 80 and over, Tomography, X-Ray Computed, Prosthesis Design, Treatment Outcome, Transcatheter Aortic Valve Replacement methods, Transcatheter Aortic Valve Replacement instrumentation, Transcatheter Aortic Valve Replacement adverse effects, Heart Valve Prosthesis, Aortic Valve surgery, Aortic Valve diagnostic imaging, Aortic Valve Stenosis surgery, Aortic Valve Stenosis diagnostic imaging, Feasibility Studies
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Background: Redo-transcatheter aortic valve implantation (TAVI) may be unfeasible because of the risk of compromising coronary flow or coronary access by the pinned back leaflets of the index transcatheter aortic valve., Aims: We aimed to evaluate the feasibility of redo-TAVI using the balloon-expandable SAPIEN 3 (S3) implanted within the self-expanding ACURATE neo2 (ACn2) valve and to identify predictors associated with a high risk of compromising coronary flow., Methods: A total of 153 post-ACn2 TAVI cardiac computed tomography scans were analysed. Redo-TAVI using an S3 was simulated in two positions: S3 outflow to the ACn2 upper crown (low implant) and S3 outflow to the base of the ACn2 commissural posts (high implant). The risk for coronary flow compromise and inaccessibility was determined by the height of the neoskirt created by the pinned back leaflets and the valve-to-aorta distances., Results: At a low S3 implant position, risk of coronary flow compromise was predicted in only 8% of patients and this increased to 60% with a high S3 position. In accordance, coronary access was predicted to be unrestricted in 52% versus 13% of patients with a low versus high S3 implantation. Female sex, a small aortic annular dimension and a sinotubular junction-to-aortic annulus mean diameter ratio <1.15 were independent predictors associated with a high risk for coronary flow compromise., Conclusions: The feasibility of redo-TAVI with an S3 in an ACn2 depends on the implant depth of the S3 and the geometry of the surrounding aorta. A low S3 implant may reduce the risk of coronary flow compromise and inaccessibility.
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- 2024
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23. Effect of cardiac amyloidosis on outcomes in transcatheter aortic valve replacement in low-flow low-gradient aortic stenosis.
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Maenza J, Chopra L, Mannina C, Vaish E, Prakash Y, Contreras J, Prandi F, Singh R, Krishnamoorthy P, Khera S, Dangas G, Tang GHL, Sharma SK, Kini AS, and Lerakis S
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Competing Interests: Declaration of competing interest Samin K. Sharma: Speaker honoraria from Abbott, Boston Scientific, Cardiovascular Systems, Inc. Dr. Khera is a consultant, speaker and proctor for Medtronic, consultant, speaker and proctor for Abbott Structural Heart, consultant and proctor for W. L. Gore & Associates, consultant for Terumo, consultant, speaker and advisory board member of EastEnd Medical, and serves on the speaker's bureau for Zoll Medical and Edwards Lifesciences. Dr. Khera also serves as the Global PI for Teleflex's ACCESS MANTA Registry (no compensation). Gilbert H. L. Tang: Has received speaker's honoraria and served as a physician proctor, consultant, advisory board member, TAVR publications committee member, APOLLO trial screening committee member and IMPACT MR steering committee member for Medtronic, has received speaker's honoraria and served as a physician proctor, consultant, advisory board member and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart, has served as an advisory board member for Boston Scientific and JenaValve, a consultant for NeoChord, Shockwave Medical, Peija Medical and Shenqi Medical Technology, and has received speaker's honoraria from Siemens Healthineers.
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- 2024
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24. The role of cardiac surgeons in transcatheter structural heart disease interventions: The evolution of cardiac surgery.
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Pirelli L, Grubb KJ, George I, Goldsweig AM, Nazif TM, Dahle G, Myers PO, Ouzounian M, Szeto WY, Maisano F, Geirsson A, Vahl TP, Kodali SK, Kaneko T, and Tang GHL
- Abstract
Competing Interests: Conflict of Interest Statement L.P. reported relationships with Edwards Lifesciences Corporation and Medtronic that include speaking and lecture fees. K.G. reported relationships with Medtronic, Abbott, Boston Scientific Corp, 4C Medical Technologies, Ancora Heart, Opsens and that include board membership, consulting or advisory, and speaking and lecture fees. I.G. reported relationships with Zimmer Biomet, AtriCure, Neosurgery, Neptube Medical, Abbvie, J&J, Durvena, Boston Scientific, Edwards Lifesciences, Medtronic, Help-TheraX, 3ive, Encompass, Summus Medical, Abbott, and Xeltis that include consulting or advisory; relationships with Edwards Surgical, Medtronic Structural Mitral & Tricuspid, Trisol Medical, Valcare Medical, Durvena, Abbvie, J&J, Foldax Medical, Zimmer, Neosurgery, Boston Scientific, Summus Medical, and BCI that include board membership; relationships with Valcare Medical, Durvena, Cardiomech, Vdyne, MitreMedical, MITRX, and BCI that include equity or stocks; and relationships with Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and JenaValve that include funding grants. A.G. reported relationships with Philips, Inari Medical, and Edwards that include consulting or advisory and speaking and lecture fees. T.N. reported relationships with Edwards, Medtronic, Boston Scientific, Opsens Medical, and Encompass that include consulting or advisory and speaking and lecture fees. G.D. reported relationships with Abbott and Edwards that include consulting or advisory and speaking and lecture fees. M.O. reported relationships with Edwards and Artivion that include speaking and lecture fees. W.S. reported relationships with Edwards, Medtronic, Artivion, Abbott, Terumo that include board membership, consulting or advisory, and speaking and lecture fees. F.M. reported relationships with Abbott, Medtronic, Edwards, Biotronik, Boston Scientific, NVT, Terumo, and Venus that include funding grants; relationships with Abbott, Medtronic, Edwards, Xeltis, Cardiovalve, Occlufit, Simulands, Mtex, Venus, Squadra, and Valgen that include consulting or advisory; and relationships with Edwards Lifesciences Corporation, Magenta, Transeptalsolutions, and 4Tech. A.G. reported relationships with Edwards and Medtronic that include consulting or advisory and speaking and lecture fees. T.V. reported relationships with Abbott, Boston Scientific, Edwards, JenaValve, and Medtronic that include funding grants; and relationships with 4C Medical and Philips that include consulting or advisory and speaking and lecture fees. S.K. reported relationships with Admedus, Dura Biotech, TriCares, Phillips, and Triflo that include consulting or advisory and speaking and lecture fees; relationships with Edwards, Medtronic, Abbott, Boston Scientific, and JenaValve that include funding grants; and relationships with Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, Admedus, TriFlo, Adona, Tioga, and X-Dot that include board membership and equity or stocks. T.K. reported relationships with Edwards, Abbott, and J&J that include board membership; and relationships with Medtronic and CardioMech that include consulting or advisory. G.T. reported relationships with Medtronic and Abbott that include consulting or advisory. P.M. reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest.
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- 2024
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25. Right coronary artery obstruction following transcatheter aortic valve replacement by aortic valve mass.
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Maidman SD, Prandi FR, Krishnamoorthy P, Tanner R, Safi L, Singh R, Stelzer P, Tang GHL, Sharma SK, Kini AS, and Lerakis S
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- Humans, Coronary Angiography, Aged, 80 and over, Female, Coronary Vessels diagnostic imaging, Coronary Vessels surgery, Male, Postoperative Complications diagnosis, Postoperative Complications etiology, Aged, Treatment Outcome, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement methods, Aortic Valve Stenosis surgery, Aortic Valve Stenosis diagnosis, Aortic Valve surgery, Aortic Valve diagnostic imaging, Coronary Occlusion diagnosis, Coronary Occlusion etiology, Coronary Occlusion surgery
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- 2024
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26. Secondary Mitral Regurgitation: Updated Review with Focus on Percutaneous Interventional Management.
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Vinayak M, Prandi FR, Safi L, Sharma A, Tang GHL, Lerakis S, Kini AS, Sharma SK, Pinney S, Lala A, and Khera S
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- Humans, Mitral Valve surgery, Mitral Valve diagnostic imaging, Disease Management, Mitral Valve Insufficiency surgery, Mitral Valve Insufficiency therapy, Cardiac Catheterization methods, Heart Valve Prosthesis Implantation methods
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Secondary mitral regurgitation (SMR) is associated with increased mortality and heart failure hospitalizations. The management of heart failure patients with SMR is complex and requires a multidisciplinary Heart Team approach. Guideline-directed medical therapies remain fundamental, yet in a proportion of patients SMR persists. In the past decade, transcatheter edge-to-edge repair (TEER) has been shown to improve survival in patients with SMR who remain symptomatic despite medical therapy. Technical advancements across newer generations of devices, improved imaging, and greater operator expertise have collectively contributed to the increased safety and efficacy of this procedure over time. Various emerging transcatheter mitral valve repair and replacement devices are currently under investigation and may offer superior, complementary or synergistic treatment options in patients ineligible for TEER. This review provides a state-of-the-art overview regarding the diagnosis of SMR, and currently available transcatheter mitral valve interventions and describes a contemporary approach to the management of SMR., Competing Interests: Conflicts of interest statement Dr. Safi is a speaker for Medtronic and Abbott. Dr. Tang has received speaker's honoraria and served as a physician proctor, consultant, advisory board member, TAVR publications committee member, APOLLO trial screening committee member and IMPACT MR steering committee member for Medtronic, has received speaker's honoraria and served as a physician proctor, consultant, advisory board member and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart, has served as an advisory board member for Boston Scientific and JenaValve, a consultant for NeoChord, Shockwave Medical, Peija Medical and Shenqi Medical Technology, and has received speaker's honoraria from Siemens Healthineers. Dr. Sharma has received speaker's bureau fees from Abbott Vascular, Boston Scientific, and Cardiovascular Systems. Dr. Khera is a consultant and proctor for Medtronic, consultant and proctor for Abbott Structural Heart, consultant for Terumo and W. L. Gore & Associates, consultant and advisory board member of EastEnd Medical, and serves on the speaker's bureau for Zoll Medical and Edwards Lifesciences. Dr. Pinney reports receiving consulting fees from: Abbott, ADI, Ancora, BMS, CareDx, Cordio, Impulse Dynamics, Medtronic, Nuwellis, Procyrion, Restore Medical, Transmedics, Valgen Medtech. The remaining authors have nothing to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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27. Use and performance of the evolut FX transcatheter aortic valve system.
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Bajwa T, Attizzani GF, Gada H, Chetcuti SJ, Williams MR, Ahmed M, Petrossian GA, Saybolt MD, Allaqaband SQ, Merhi WM, Stoler RC, Bezerra H, Mahoney P, Wu W, Jumper R, Lambrecht L, and Tang GHL
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- Aged, Female, Humans, Male, Health Care Surveys, Hemodynamics, Recovery of Function, Time Factors, Treatment Outcome, Aortic Valve surgery, Aortic Valve diagnostic imaging, Aortic Valve physiopathology, Aortic Valve Stenosis surgery, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis physiopathology, Heart Valve Prosthesis, Prosthesis Design, Transcatheter Aortic Valve Replacement instrumentation
- Abstract
Background: The next generation supra-annular, self-expanding Evolut FX transcatheter aortic valve (TAV) system was designed to improve catheter deliverability, provide stable and symmetric valve deployment, and assess commissural alignment during the procedure. The impact of these modifications has not been clinically evaluated., Methods: Procedural information was collected by survey in 2 Stages: Stage I comprised 23 centers with extensive experience with Evolut TAV systems, and Stage II comprised an additional 46 centers with a broad range of balloon- and self-expanding system experience. Operators were to compare the experience with the Evolut FX to the predicate Evolut PRO+ system., Results: There were 285 cases during Stage I from June 24 to August 12, 2022, and 254 cases during Stage II from August 15 to September 11, 2022. Overall, the cusp overlap technique was used in 88.6 %, and commissural alignment was achieved in 96.1 % of these cases. Compared to implanter's previous experience with the Evolut PRO+ system, less resistance was noted with the Evolut FX system: in 83.0 % of cases during vascular insertion, in 84.7 % of cases while tracking through the vasculature, in 84.4 % of cases while traversing over the arch, and 76.1 % of cases in advancing across the valve. Better symmetry of valve depth was observed in 423 of 525 cases (80.6 %)., Conclusion: Evolut FX system design modifications translated into improvements in catheter deliverability, deployment symmetry and stability, and commissural alignment as assessed by experienced self-expanding and balloon expandable operators., Competing Interests: Declaration of competing interest Dr. Bajwa reports fees for consulting and proctoring from Medtronic; Dr. Attizzani is a consultant for Medtronic and Abbott Vascular; and serves as a proctor and is on the advisory board for Medtronic; Dr. Gada is a consultant to Abbott, Bard, Edwards LifeSciences and Medtronic; Dr. Chetcuti has received grant support and fees for proctoring from Medtronic and is a consultant for Jena valve; Dr. Williams reported personal fees from Medtronic during the conduct of the study and consulting fees from Medtronic outside the submitted work; Dr. Ahmed has no disclosures; Dr. Petrossian has no disclosures; Dr. Saybolt serves on the Medtronic Coronary and Renal Denervation Global Advisory Board; as a consultant to Abbott, Edwards Lifesciences, Medtronic and Shockwave, and has received a research grant from Infraredx; Dr. Allaqaband is a proctor and consultant for Medtronic; Dr. Mehri has no disclosures; Dr. Stoler serves as a proctor for Medtronic and Edwards Lifesciences; Dr. Bezerra has no disclosures; Dr. Mahoney is a consultant and proctor for Medtronic, Abbott, and Edwards; Dr. Wu has no disclosures; Dr. Jumper has no disclosures; Dr. Lambrecht is an employee and shareholder of Medtronic, plc; Dr. Tang has received speaker's honoraria and served as a physician proctor, consultant, advisory board member, TAVR publications committee member, APOLLO trial screening committee member and IMPACT MR steering committee member for Medtronic, has received speaker's honoraria and served as a physician proctor, consultant, advisory board member and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart, has served as an advisory board member for Boston Scientific and JenaValve, a consultant for NeoChord, Shockwave Medical, Peija Medical and Shenqi Medical Technology, and has received speaker's honoraria from Siemens Healthineers., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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28. Outcomes Following Transcatheter Mitral Valve Replacement Using Dedicated Devices in Patients With Mitral Annular Calcification.
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Coisne A, Ludwig S, Scotti A, Ben Ali W, Weimann J, Duncan A, Webb JG, Kalbacher D, Rudolph TK, Nickenig G, Hausleiter J, Ruge H, Adam M, Petronio AS, Dumonteil N, Søndergaard L, Adamo M, Regazzoli D, Garatti A, Schmidt T, Dahle G, Taramasso M, Walther T, Kempfert J, Obadia JF, Redwood S, Tang GHL, Goel S, Fam N, Metra M, Andreas M, Muller DW, Denti P, Praz F, von Bardeleben RS, Leroux L, Latib A, Granada JF, Conradi L, and Modine T
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- Aged, Aged, 80 and over, Female, Humans, Male, Europe, Prosthesis Design, Recovery of Function, Registries, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, Calcinosis diagnostic imaging, Calcinosis surgery, Calcinosis mortality, Calcinosis physiopathology, Calcinosis therapy, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects, Cardiac Catheterization mortality, Feasibility Studies, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation mortality, Mitral Valve diagnostic imaging, Mitral Valve physiopathology, Mitral Valve surgery, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency physiopathology, Mitral Valve Insufficiency surgery, Mitral Valve Insufficiency mortality
- Abstract
Background: Patients with mitral regurgitation (MR) and morphologic presence of relevant mitral annular calcification (MAC) represent a challenging phenotypic subset with limited treatment options., Objectives: The aim of this study was to assess the feasibility of transcatheter mitral valve replacement (TMVR) using dedicated devices for the treatment of MAC patients., Methods: Consecutive patients with symptomatic MR receiving TMVR and with available computed tomography data from the CHOICE-MI (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) multicenter registry were stratified by the presence of none or mild mitral annular calcification (MAC
none/mild ) vs moderate or severe mitral annular calcification (MACmod/sev )., Results: Among 279 eligible patients (median age = 76.0 years [Q1-Q3: 71.0-81.0 years], EuroSCORE II = 6.2% [Q1-Q3: 3.9%-12.1%]), 222 (79.6%) presented with MACnone/mild and 57 (20.4%) with MACmod/sev . Patients with MACmod/sev had a higher prevalence of extracardiac arteriopathy (P = 0.011) and primary MR (P < 0.001). Although the technical success rate and the extent of MR elimination did not differ, TMVR treatment in MACmod/sev patients was associated with higher rates of postprocedural bleeding complications (P = 0.02) and renal failure (P < 0.001). Functional improvement at the 1- and 2-year follow-up did not differ between groups. At the 2-year follow-up, there were no differences between patients with MACmod/sev and MACnone/mild regarding all-cause mortality (38.5% vs 37.7%; P = 0.76), cardiovascular mortality (21.3% vs 24.9%; P = 0.97), and all-cause mortality or heart failure hospitalization (52.4% vs 46.7%; P = 0.28) CONCLUSIONS: TMVR in patients with MACmod/sev is associated with higher rates of postprocedural complications but similar rates of survival, MR resolution, and functional improvement compared to MACnone/mild . Further studies are necessary to define the role of dedicated TMVR devices in this population. (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry [CHOICE-MI]; NCT04688190)., Competing Interests: Funding Support and Author Disclosures This study was supported by a grant from the German Heart Foundation. Dr Coisne is a proctor for Abbott Vascular; and has received speaker fees for Abbot Vascular, Edwards Lifesciences, GE Healthcare, Merck Sharp & Dohme, and Pfizer. Dr Ludwig has received travel compensation from Edwards Lifesciences; has received honoraria from Bayer and Abbott; is a consultant for NVT; and was supported by a research grant from the German Heart Foundation. Dr Ali has received research grants from Medtronic and Edwards Lifesciences. Dr Duncan is a consultant for and has received honoraria from Abbott Laboratories, Edward Lifesciences, and Medtronic. Dr Kalbacher has received personal fees from Abbott, Edwards Lifesciences, Pi-Cardia Ltd, and Medtronic. Dr Rudolph has received speaker honoraria from Abbott Vascular. Dr Hausleiter has received consulting fees, speaker honoraria, and support of research projects paid to the institution from Abbott Vascular and Edwards Lifesciences. Dr Ruge serves as a physician proctor for Abbott and Edwards Lifesciences; is a consultant for Medtronic, Abbott, and Edwards Lifesciences; and is a member of the Abbott Advisory Board. Dr Schmidt has received consultant fees and travel support from Cardiovalve. Dr Taramasso is consultant or has received consultancy fees from Abbott, Edwards Lifesciences, Medtronic, Boston Scientific, Shenqi Medical, MEDIRA, PiCardia, CoreMedic, Cardiovalve, Simulands, CoreQuest, HiD Imaging, and OneCrea Medical. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences; and has received consultant fees from Approxima, HVR, InnovHeart, and Pi-Cardia Ltd. Dr Andreas is a proctor, consultant, and speaker for Edwards Lifesciences, Abbott, Medtronic, Boston, and Zoll; and has received institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
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29. Valve-in-Ring Transcatheter Mitral Valve Replacement in a Fluoroscopically Invisible Ring.
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Chiu HAC, Wong CK, Chan DT, Chan EK, Tang GHL, and Lam SC
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Tang has received honoraria for speaking from Medtronic; has served as a physician proctor, consultant, advisory board member, TAVR publications committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received honoraria for speaking from Abbott Structural Heart; has served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve; has served as a consultant and physician screening committee member for Shockwave Medical; has served as a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received honoraria for speaking from Siemens Healthineers. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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30. TRIVALVE Score: A Risk Score for Mortality/Hospitalization Prediction in Patients Undergoing Transcatheter Tricuspid Valve Intervention.
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Russo G, Pedicino D, Pires Marafon D, Adamo M, Alessandrini H, Andreas M, Braun D, Connelly KA, Denti P, Estevez-Loureiro R, Fam N, Hahn RT, Harr C, Hausleiter J, Himbert D, Kalbacher D, Ho E, Latib A, Lentini N, Lubos E, Ludwig S, Lurz P, Metra M, Monivas V, Nickenig G, Pastorino R, Pedrazzini G, Pozzoli A, Praz F, Rodes-Cabau J, Besler C, Rommel KP, Schofer J, Scotti A, Piayda K, Sievert H, Tang GHL, Thiele H, Schlotter F, von Bardeleben RS, Webb JG, Windecker S, Leon M, Enriquez-Sarano M, Maisano F, Crea F, and Taramasso M
- Subjects
- Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Clinical Decision-Making, Registries, Reproducibility of Results, Risk Assessment, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, Cardiac Catheterization adverse effects, Cardiac Catheterization mortality, Cardiac Catheterization instrumentation, Decision Support Techniques, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation mortality, Heart Valve Prosthesis Implantation instrumentation, Patient Readmission, Predictive Value of Tests, Tricuspid Valve physiopathology, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Tricuspid Valve Insufficiency mortality, Tricuspid Valve Insufficiency physiopathology, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery
- Abstract
Background: Transcatheter tricuspid valve intervention (TTVI) has been increasingly adopted in recent years for the treatment of patients with tricuspid regurgitation (TR). However, no dedicated risk stratification has been established for patients undergoing TTVI., Objectives: The aim of the present study was to propose a dedicated risk score for patients affected by severe TR undergoing TTVI., Methods: The score was derived from the TRIVALVE (International Multisite Transcatheter Tricuspid Valve Therapies Registry; NCT03416166) registry, according to data availability. A stepwise model approach was used on predictor variables to develop a scoring system for predicting 12-month mortality or rehospitalization using multivariable logistic regression. Internal discrimination, calibration, and validation were assessed using receiver-operating characteristic curve analysis and bootstrapping with 1,000 resamples., Results: A total of 483 patients were included in the study, with an overall 12-month mortality or rehospitalization rate of 19% (n = 94). The final risk score, ranging from 0 to 4.5, included the following 5 parameters (adjusted for age and gender): 1) atrial fibrillation at baseline; 2) glomerular filtration rate <30 mL/min; 3) elevated gamma-glutamyl transferase/bilirubin levels; 4) signs of right heart failure; and 5) left ventricular ejection fraction <50%. The bias-corrected area under the receiver-operating characteristic curve was 68% (95% CI: 62%-75%). A cutoff value of 2.5 demonstrated sensitivity of 65.4% and specificity of 60.5% for the outcome., Conclusions: The present study proposes a dedicated risk score for patients undergoing TTVI, providing an additional and simple tool for heart teams to select the best therapy for patients affected by severe TR., Competing Interests: Funding Support and Author Disclosures Dr Russo has received a fellowship training grant from the European Association of Percutaneous Cardiovascular Interventions, sponsored by Edwards Lifesciences. Dr Adamo has received personal fees from Abbott Vascular, Medtronic, and Novartis. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; has stock options with NaviGate; and is chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Andreas is a proctor, consultant, and speaker for Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, and Zoll; and has received institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI Solutions. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences. Dr Estevez-Loureiro is a consultant for Abbott Vascular, Boston Scientific, and Edwards Lifesciences. Dr Nickenig has received honoraria for lectures or advisory board membership from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Schofer is a consultant for Edwards Lifesciences. Dr Sievert has received study honoraria to the institution, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Adona Medical, Akura Medical, Ancora Heart, Append Medical, Axon, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Cardiac Dimensions, Cardiac Success, Cardimed, Cardionovum, CeloNova Biosciences, Contego, Coramaze, CroíValve, CSL Behring, CVRx, Dinova, Edwards Lifesciences, EndoBar, Endologix, EndoMatic, Esperion Therapeutics, Hangzhou Nuomao Medtech, Holistick Medical, InterShunt Technologies, Intervene, K2, Laminar, Life Tech Care, Magenta, Maquet Getinge Group, Metavention, Mitralix, Mokita, Neurotronic, NXT Biomedical, Occlutech, Recor, Renal Guard, Shifamed, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, Vivasure Medical, Vvital Biomed, and WhiteSwell. Dr Tang has served as a physician proctor for Medtronic; has served as a consultant for Medtronic, Abbott Structural Heart, and NeoChord; has served on the transcatheter aortic valve replacement advisory board for Abbott Structural Heart; and has served on the physician advisory board for JenaValve. Dr von Bardeleben has served for trials and as a principal investigator for Abbott, Edwards Lifesciences, and Medtronic. Dr Windecker has received research, travel, or educational grants to the institution from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, Cardiovalve, CorFlow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Guerbet, Infraredx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as an advisory board member and/or a member of the steering or executive groups of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave, and Xeltis, with payments to the institution but no personal payments; and is a member of the steering or executive committee groups of several investigator-initiated trials that receive funding from industry, without impact on his personal remuneration. Dr Enriquez-Sarano is a consultant for Edwards Lifesciences, ChemImage, Cryolife, and HighLife. Dr Maisano is a consultant for Abbott Vascular, Medtronic, Edwards Lifesciences, Perifect, Xeltis, Transseptal Solutions, Magenta, and Cardiovalve; has received grant support from Abbott Vascular, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received royalties from Edwards Lifesciences and 4Tech; and is a cofounder and shareholder of Transseptal Solutions, 4Tech, Cardiovalve, Magenta, Perifect, Coregard and SwissVortex. Dr Taramasso has received consultancy fees from Abbott Vascular, Edwards Lifesciences, 4Tech, Boston Scientific, CoreMedic, Mitraltech, and SwissVortex (outside the submitted work). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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31. Percutaneous Edge-to-Edge Repair for Tricuspid Regurgitation: 3-Year Outcomes From the TRILUMINATE Study.
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Nickenig G, Lurz P, Sorajja P, von Bardeleben RS, Sitges M, Tang GHL, Hausleiter J, Trochu JN, Näbauer M, Heitkemper M, Ying SW, Weber M, and Hahn RT
- Subjects
- Humans, Female, Prospective Studies, Treatment Outcome, Male, Aged, Time Factors, Middle Aged, Prosthesis Design, Aged, 80 and over, United States, Europe, Functional Status, Tricuspid Valve Insufficiency physiopathology, Tricuspid Valve Insufficiency surgery, Tricuspid Valve Insufficiency diagnostic imaging, Quality of Life, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects, Recovery of Function, Severity of Illness Index, Tricuspid Valve surgery, Tricuspid Valve physiopathology, Tricuspid Valve diagnostic imaging
- Abstract
Background: Tricuspid regurgitation (TR) is a common valve disease that has a significant impact on patients' quality of life., Objectives: This study sought to report the final 3-year outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) with the TriClip (Abbott) implant from the TRILUMINATE (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR) study for the treatment of severe symptomatic TR., Methods: The TRILUMINATE study (N = 98 subjects) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of T-TEER with the TriClip implant in patients with symptomatic moderate or greater TR. Echocardiographic assessments were performed at a core laboratory., Results: At 3 years, TR was reduced to moderate or less in 79% of subjects, and a reduction of at least 1 grade was achieved in 92% of subjects. TR reduction achieved at 1 year was sustained through 3 years. Subjects also experienced an improvement in heart failure symptoms assessed by NYHA functional class and quality of life assessed by the Kansas City Cardiomyopathy Questionnaire at 3 years compared to baseline. The site-reported heart failure hospitalization rate decreased from 0.56 events/patient-year 1 year before device implantation to 0.14 events/patient-year 3 years after device implantation, representing a reduction of 75% (P < 0.0001)., Conclusions: In the longest follow-up to date of any T-TEER therapy, the TRILUMINATE study demonstrated that the TriClip procedure is both safe and effective, with sustained benefits at 3 years in subjects with symptomatic moderate or greater TR. (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR [TRILUMINATE]; NCT03227757)., Competing Interests: Funding Support and Author Disclosures This study was supported by Abbott Structural Heart. Dr Nickenig has received research funding and honoraria from Abbott, Edwards Lifesciences, and Medtronic; and has participated in clinical trials with Abbott, Edwards Lifesciences, and Medtronic. Dr Lurz has served as a consultant for Abbott Structural Heart, Edwards Lifesciences, Medtronic, ReCor, and Occlutech. Dr Sorajja has served as a consultant for 4C Medical, Abbott Structural, Adona, Boston Scientific, Edwards Lifesciences, Foldax, GE Medical, GLG, Medtronic, Phillips, Siemens, WL Gore, vDyne, and xDot; and has received personal fees from Abbott Vascular (outside the submitted work). Dr von Bardeleben has received institutional research grants and speaker honorarium from Abbott Vascular and Edwards Lifesciences; and has received nonfinancial trial support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Lifetec, and Medtronic. Dr Sitges has served as a consultant for Abbott, Edwards Lifesciences, Metronic, and General Electric; has received speaker honoraria from Abbott, Edwards Lifesciences, Medtronic, and General Electric; and has received speaker honoraria and travel and grant support from Abbott. Dr Hausleiter has received speaker honoraria and research support from Abbott Vascular and Edwards Lifesciences. Dr Trochu has received speaker honoraria, travel support, and grant support from Abbott and Novartis; has received honoraria for lectures or advisory boards from Amgen, Bayer, and Resmed; and has been an unpaid member of the Corvia Medical Scientific Advisory Group. Dr Näbauer has received speaker honoraria from Abbott. Dr Heitkemper is an employee of Abbott. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; and has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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32. A Journal for Everyone, by Everyone: The Next Era of JACC: Case Reports .
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Tang GHL
- Abstract
Competing Interests: Dr Tang has received speaker honoraria and served as a physician proctor, consultant, advisory board member, TAVR publications committee member, RESTORE study steering committee member, APOLLO trial screening committee member and IMPACT MR steering committee member for Medtronic, has received speaker honoraria and served as a physician proctor, consultant, advisory board member and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart, has served as an advisory board member for Boston Scientific and JenaValve, a consultant and physician screening committee member for Shockwave Medical, a consultant for NeoChord, Peija Medical and Shenqi Medical Technology, and has received speaker honoraria from Siemens Healthineers
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33. Transcatheter aortic valve replacement in a patient with quadricuspid aortic valve stenosis and regurgitation.
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Bienstock SW, Krishnamoorthy P, Tang GHL, Lerakis S, Sharma SK, Kini AS, and Safi LM
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- Humans, Aged, 80 and over, Female, Echocardiography, Transesophageal methods, Severity of Illness Index, Treatment Outcome, Heart Valve Prosthesis, Aortic Valve Stenosis surgery, Aortic Valve Stenosis diagnosis, Aortic Valve Stenosis complications, Transcatheter Aortic Valve Replacement methods, Aortic Valve surgery, Aortic Valve abnormalities, Aortic Valve diagnostic imaging, Aortic Valve Insufficiency surgery, Aortic Valve Insufficiency diagnosis, Aortic Valve Insufficiency etiology
- Abstract
We report the case of an 80-year-old woman with known quadricuspid aortic valve (QAV), severe aortic stenosis, and moderate-to-severe regurgitation who recently underwent a transcatheter aortic valve replacement (TAVR).
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34. A Guide to Transcatheter Aortic Valve Design and Systematic Planning for a Redo-TAV (TAV-in-TAV) Procedure.
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Bapat VN, Fukui M, Zaid S, Okada A, Jilaihawi H, Rogers T, Khalique O, Cavalcante JL, Landes U, Sathananthan J, Tarantini G, Tang GHL, Blackman DJ, De Backer O, Mack MJ, and Leon MB
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- Humans, Treatment Outcome, Risk Factors, Clinical Decision-Making, Aortic Valve Stenosis surgery, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis physiopathology, Terminology as Topic, Predictive Value of Tests, Transcatheter Aortic Valve Replacement instrumentation, Transcatheter Aortic Valve Replacement adverse effects, Heart Valve Prosthesis, Prosthesis Design, Aortic Valve surgery, Aortic Valve diagnostic imaging, Aortic Valve physiopathology, Reoperation
- Abstract
Transcatheter aortic valve replacement (TAVR) has become more common than surgical aortic valve replacement since 2016, with over 200,000 procedures globally each year. As patients increasingly outlive their TAVR devices, managing these cases is a growing concern. Treatment options include surgical removal of the old TAVR device (transcatheter aortic valve [TAV] explant) or implantation of a new transcatheter aortic valve (redo TAV). Redo TAV is complex because of the unique designs of TAV devices; compatibility issues; and the need for individualized planning based on factors such as implant depth, shape, and coronary artery relationships. This review serves as a comprehensive guide for redo TAV, detailing the design characteristics of TAV devices, device compatibility, standardized terminology, and a structured approach for computed tomography analysis. It aims to facilitate decision making, risk identification, and achieving optimal outcomes in redo TAV procedures., Competing Interests: Funding Support and Author Disclosures Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, Abbott, Anteris, Meril Lifesciences, and Boston Scientific. Dr Jilaihawi has received institutional research grants and consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic Inc; and has received institutional research grants from Boston Scientific and Pi-Cardia. Dr Rogers is a consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and Transmural Systems; serves on advisory boards for Medtronic and Boston Scientific; holds an equity interest in Transmural Systems; and is a coinventor on patents, assigned to National Institutes of Health, for transcatheter electrosurgery devices. Dr Khalique is a consultant for Edwards Lifesciences, Restore Medical, Croivalve, Heartflow, and Vdyne; and holds equity in Triflo. Dr Cavalcante is a consultant for 3Mensio, 4C Medical, Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, JenaValve, Medtronic, and Siemens Healthineers. Dr Landes has received consulting fees from Edwards Lifesciences. Dr Sathananthan has received speaker fees from Edwards Lifesciences, Medtronic, NVT Medical, and Boston Scientific; is a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Anteris; and serves as chief medical officer for structural division of Boston Scientific. Dr Tarantini has received lecture fees from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientifics. Dr Tang has received speaker honoraria and has served as a physician proctor, consultant, advisory board member, TAVR publications committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria and has served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve, a consultant and physician screening committee member for Shockwave Medical, a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Blackman is a consultant, proctor, and advisory board member for Medtronic and Abbott Vascular; and has received institutional research grants from Medtronic. Dr De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Mack served as co–primary investigator for the PARTNER trial for Edwards Lifesciences and the COAPT trial for Abbott; and has served as study chair for the APOLLO trial for Medtronic. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic; and has received stock options (equity) for advisory board participation in Valve Medical, Picardia, and Venus MedTech. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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35. Transcatheter heart valve explant with infective endocarditis-associated prosthesis failure and outcomes: the EXPLANT-TAVR international registry.
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Marin-Cuartas M, Tang GHL, Kiefer P, Fukuhara S, Lange R, Harrington KB, Saha S, Hagl C, Kleiman NS, Goel SS, Kempfert J, Werner P, Petrossian GA, Geirsson A, Desai ND, Chu MWA, Bhadra OD, Shults C, Garatti A, Vincent F, Grubb KJ, Goldberg JB, Mack MJ, Modine T, Denti P, Kaneko T, Bapat VN, Reardon MJ, Borger MA, and Zaid S
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- Humans, Male, Female, Aged, Device Removal, Heart Valve Prosthesis adverse effects, Bioprosthesis adverse effects, Treatment Outcome, Aged, 80 and over, Postoperative Complications epidemiology, Postoperative Complications etiology, Registries, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement mortality, Prosthesis Failure, Prosthesis-Related Infections epidemiology, Prosthesis-Related Infections mortality, Endocarditis surgery, Endocarditis mortality
- Abstract
Background and Aims: Surgical explantation of transcatheter heart valves (THVs) is rapidly increasing, but there are limited data on patients with THV-associated infective endocarditis (IE). This study aims to assess the outcomes of patients undergoing THV explant for IE., Methods: All patients who underwent THV explant between 2011 and 2022 from 44 sites in the EXPLANT-TAVR registry were identified. Patients with IE as the reason for THV explant were compared to those with other mechanisms of bioprosthetic valve dysfunction (BVD)., Results: A total of 372 patients from the EXPLANT-TAVR registry were included. Among them, 184 (49.5%) patients underwent THV explant due to IE and 188 (50.5%) patients due to BVD. At the index transcatheter aortic valve replacement, patients undergoing THV explant for IE were older (74.3 ± 8.6 vs. 71 ± 10.6 years) and had a lower Society of Thoracic Surgeons risk score [2.6% (1.8-5.0) vs. 3.3% (2.1-5.6), P = .029] compared to patients with BVD. Compared to BVD, IE patients had longer intensive care unit and hospital stays (P < .05) and higher stroke rates at 30 days (8.6% vs. 2.9%, P = .032) and 1 year (16.2% vs. 5.2%, P = .010). Adjusted in-hospital, 30-day, and 1-year mortality was 12.1%, 16.1%, and 33.8%, respectively, for the entire cohort, with no significant differences between groups. Although mortality was numerically higher in IE patients 3 years postsurgery (29.6% for BVD vs. 43.9% for IE), Kaplan-Meier analysis showed no significant differences between groups (P = .16)., Conclusions: In the EXPLANT-TAVR registry, patients undergoing THV explant for IE had higher 30-day and 1-year stroke rates and longer intensive care unit and hospital stays. Moreover, patients undergoing THV explant for IE had a higher 3-year mortality rate, which did not reach statistical significance given the relatively small sample size of this unique cohort and the reduced number of events., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
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36. Transcatheter or Surgical Replacement for Failed Bioprosthetic Aortic Valves.
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Tran JH, Itagaki S, Zeng Q, Leon MB, O'Gara PT, Mack MJ, Gillinov AM, El-Hamamsy I, Tang GHL, Mikami T, Bagiella E, Moskowitz AJ, Adams DH, Gelijns AC, Borger MA, and Egorova NN
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- Humans, Female, Male, Aged, Retrospective Studies, Aged, 80 and over, Heart Valve Prosthesis, Postoperative Complications epidemiology, Prosthesis Failure, Aortic Valve surgery, Aortic Valve Stenosis surgery, Heart Valve Prosthesis Implantation methods, Bioprosthesis, Transcatheter Aortic Valve Replacement methods, Reoperation statistics & numerical data
- Abstract
Importance: The use of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has been rapidly expanding as an alternative treatment to redo surgical aortic valve replacement (SAVR) for failed bioprosthetic valves despite limited long-term data., Objective: To assess mortality and morbidity in patients undergoing intervention for failed bioprosthetic SAVR., Design, Setting, and Participants: This was a retrospective population-based cohort analysis conducted between January 1, 2015, and December 31, 2020, with a median (IQR) follow-up time of 2.3 (1.1-4.0) years. A total of 1771 patients with a history of bioprosthetic SAVR who underwent ViV-TAVR or redo SAVR in California, New York, and New Jersey were included. Data were obtained from the California Department of Health Care Access and Information, the New York Statewide Planning and Research Cooperative System, and the New Jersey Discharge Data Collection System. Exclusion criteria included undergoing TAVR or redo SAVR within 5 years from initial SAVR, as well as infective endocarditis, concomitant surgical procedures, and out-of-state residency. Propensity matching yielded 375 patient pairs. Data were analyzed from January to December 2023., Interventions: ViV-TAVR vs redo SAVR., Main Outcomes and Measurements: The primary outcome was all-cause mortality. Secondary outcomes were stroke, heart failure hospitalization, reoperation, major bleeding, acute kidney failure, new pacemaker insertion, and infective endocarditis., Results: From 2015 through 2020, the proportion of patients undergoing ViV-TAVR vs redo SAVR increased from 159 of 451 (35.3%) to 498 or 797 (62.5%). Of 1771 participants, 653 (36.9%) were female, and the mean (SD) age was 74.4 (11.3) years. Periprocedural mortality and stroke rates were similar between propensity-matched groups. The ViV-TAVR group had lower periprocedural rates of major bleeding (2.4% vs 5.1%; P = .05), acute kidney failure (1.3% vs 7.2%; P < .001), and new pacemaker implantations (3.5% vs 10.9%; P < .001). The 5-year all-cause mortality rate was 23.4% (95% CI, 15.7-34.1) in the ViV-TAVR group and 13.3% (95% CI, 9.2-18.9) in the redo SAVR group. In a landmark analysis, no difference in mortality was observed up to 2 years (hazard ratio, 1.03; 95% CI, 0.59-1.78), but after 2 years, ViV-TAVR was associated with higher mortality (hazard ratio, 2.97; 95% CI, 1.18-7.47) as well as with a higher incidence of heart failure hospitalization (hazard ratio, 3.81; 95% CI, 1.57-9.22). There were no differences in 5-year incidence of stroke, reoperation, major bleeding, or infective endocarditis., Conclusions and Relevance: Compared with redo SAVR, ViV-TAVR was associated with a lower incidence of periprocedural complications and a similar incidence of all-cause mortality through 2 years' follow-up. However, ViV-TAVR was associated with higher rates of late mortality and heart failure hospitalization. These findings may be influenced by residual confounding and require adjudication in a randomized clinical trial.
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37. Transcatheter Edge-to-Edge Approach to Repair Large Coaptation Gaps: The Zipping Technique.
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Passaniti G, Tang GHL, Tanner R, Sharma SK, Kini AS, and Lerakis S
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- Humans, Treatment Outcome, Mitral Valve surgery, Mitral Valve diagnostic imaging, Mitral Valve physiopathology, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Insufficiency surgery, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency physiopathology, Cardiac Catheterization instrumentation
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Tang has received speaker honoraria and has served as a physician proctor, consultant, Advisory Board member, TAVR Publications Committee member, APOLLO Trial Screening Committee member, and IMPACT MR Steering Committee member for Medtronic; has received speaker honoraria and has served as a physician proctor, consultant, Advisory Board member, and TRILUMINATE Trial Anatomic Eligibility and Publications Committee member for Abbott Structural Heart; has served as an Advisory Board member for Boston Scientific and JenaValve; has served as a consultant for NeoChord, Shockwave Medical, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Lerakis is a member of the Publication Imaging Subcommittee for the TRILUMINATE Pivotal Trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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- 2024
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38. Prognostic Implications of Residual Tricuspid Regurgitation Grading After Transcatheter Tricuspid Valve Repair.
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Dreyfus J, Taramasso M, Kresoja KP, Omran H, Iliadis C, Russo G, Weber M, Nombela-Franco L, Estevez Loureiro R, Hausleiter J, Latib A, Stolz L, Praz F, Windecker S, Zamorano JL, von Bardeleben RS, Tang GHL, Hahn R, Lubos E, Webb J, Schofer J, Fam N, Lauten A, Pedrazzini G, Rodés-Cabau J, Nejjari M, Badano L, Alessandrini H, Himbert D, Sievert H, Piayda K, Donal E, Modine T, Nickenig G, Pfister R, Rudolph V, Bernick J, Wells GA, Bax J, Lurz P, Enriquez-Sarano M, Maisano F, and Messika-Zeitoun D
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- Humans, Male, Female, Aged, Treatment Outcome, Time Factors, Risk Factors, Aged, 80 and over, Middle Aged, Risk Assessment, Registries, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery, Tricuspid Valve Insufficiency physiopathology, Tricuspid Valve Insufficiency mortality, Severity of Illness Index, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Tricuspid Valve physiopathology, Cardiac Catheterization adverse effects, Cardiac Catheterization mortality, Cardiac Catheterization instrumentation, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation mortality
- Abstract
Background: The safety profile of transcatheter tricuspid valve (TTV) repair techniques is well established, but residual tricuspid regurgitation (TR) remains a concern., Objectives: The authors sought to assess the impact of residual TR severity post-TTV repair on survival., Methods: We evaluated the survival rate at 2 years of 613 patients with severe isolated functional TR who underwent TTV repair in TRIGISTRY according to the severity of residual TR at discharge using a 3-grade (mild, moderate, and severe) or 4-grade scheme (mild, mild to moderate, moderate to severe, and severe)., Results: Residual TR was none/mild in 33%, moderate in 52%, and severe in 15%. The 2-year adjusted survival rates significantly differed between the 3 groups (85%, 70%, and 44%, respectively; restricted mean survival time [RMST]: P = 0.0001). When the 319 patients with moderate residual TR were subdivided into mild to moderate (n = 201, 33%) and moderate to severe (n = 118, 19%), the adjusted survival rate was also significantly different between groups (85%, 80%, 55%, and 44%, respectively; RMST: P = 0.001). Survival was significantly lower in patients with moderate to severe residual TR compared to patients with mild to moderate residual TR (P = 0.006). No difference in survival rates was observed between patients with no/mild and mild to moderate residual TR (P = 0.67) or between patients with moderate to severe and severe residual TR (P = 0.96)., Conclusions: The moderate residual TR group was heterogeneous and encompassed patients with markedly different clinical outcomes. Refining TR grade classification with a more granular 4-grade scheme improved outcome prediction. Our results highlight the importance of achieving a mild to moderate or lower residual TR grade during TTV repair, which could define a successful intervention., Competing Interests: Funding Support and Author Disclosures Dr Dreyfus has received speaker or proctoring fees from Abbott. Dr Kresoja has received consulting fees from Edwards Lifesciences. Dr Taramasso has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, Medtronic, Boston Scientific, Shenqi Medical, PiCardia, CoreMedic, VentriMend, MEDIRA, CoreQuest, and HiD Imaging. Dr Iliadis has received consulting fees from Abbott Vascular and Edwards Lifesciences. Dr Nombela-Franco has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, and Products and Features. Dr Estevez-Loureiro has received speaker fees from Abbott Vascular, Edwards Lifesciences, Boston Scientific, and Venus Medtech. Dr Hausleiter has received grants and consulting fees from Edwards Lifesciences. Dr Stolz has received consulting or speaker fees from Edwards Lifesciences. Dr Windecker has received research, travel, or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse Inc Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medalliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, MonarQ, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as an Advisory Board member and/or member of the Steering/Executive Group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments; and has served as a member of the Steering/Executive Committee Group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Zamorano has received consulting or speaker fees from Novartis, Bayer, and Pfizer. Dr von Bardeleben has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, Medtronic, Philips, and Siemens. Dr Tang has received speaker honoraria and has served as a physician proctor, consultant, Advisory Board member, TAVR Publications Committee Member, APOLLO Trial Screening Committee Member, and IMPACT MR Steering Committee member for Medtronic; has received speaker honoraria and has served as a physician proctor, consultant, Advisory Board member, and TRILUMINATE Trial Anatomic Eligibility and Publications Committee member for Abbott Structural Heart; has served as an Advisory Board member for Boston Scientific and JenaValve; has served as a consultant and Physician Screening Committee Member for Shockwave Medical; has served as a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Hahn has received speaker fees from Boston Scientific, Edwards Lifesciences, and Philips Healthcare. Dr Webb has received consulting fees from Edwards Lifesciences; and has received research funding from Medtronic, Abbott, Boston Scientific, and Edwards Lifesciences. Dr Lauten has received speaker fees from Boehringer Ingelheim, Medtronic, Amgen, Bayer, Novartis, Sanofi, Chiesi, and AstraZeneca; and is a shareholder of the Devie Medical Drug Eluting Valve for Endocarditis Treatment. Dr Rodés-Cabau has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, and Medtronic. Dr Nejjari has received consulting or speaker fees from Abbott Vascular, Medtronic, Edwards Lifesciences, Boston Scientific, and Robocath. Dr Badano has received consulting or speaker fees from Edwards Lifesciences, GE Healthcare, and Philips Medical Systems. Dr Himbert has received proctoring fees from Edwards Lifesciences and Abbott Vascular. Dr Modine has received speaker or consulting fees from Abbott, Edwards Lifesciences, Medtronic, Microport, and GE. Dr Rudolph has received consulting or speaker fees from Abbott Vascular and Edwards Lifesciences. Dr Bax has received lecture fees from Abbott and Edwards Lifesciences. Dr Lurz has received consulting fees from Abbott Medical, Innoventric, and Edwards Lifesciences. Dr Maisano has received grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific Corporation, NVT, Terumo, Venus, and 3mensio; has received consulting fees and personal and institutional honoraria from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, Mtex, Venus, and Squadra; has received royalty income/IP rights from Edwards Lifesciences; and is a shareholder (including share options) in Cardiogard, Cardiovalve, Magenta, SwissVortex, Transseptalsolutions, and 4Tech. Dr Messika-Zeitoun has received research grants from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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39. Hydrodynamic Assessment of Explanted Degenerated Transcatheter Aortic Valves: Novel Insights Into Noncalcific and Calcific Mechanisms.
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Sathananthan J, Nigade A, Meier D, Navarro D, Spencer J, Lai A, Gill H, Pirelli L, Webb JG, Wood DA, Lutter G, Puehler T, Tang GHL, Fukuhara S, and Sellers SL
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- Humans, Aged, Female, Aged, 80 and over, Male, Middle Aged, Time Factors, Device Removal, Aortic Valve Stenosis physiopathology, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Hemodynamics, Biomechanical Phenomena, Materials Testing, Video Recording, Heart Valve Prosthesis, Aortic Valve physiopathology, Aortic Valve diagnostic imaging, Aortic Valve surgery, Aortic Valve pathology, Calcinosis physiopathology, Calcinosis diagnostic imaging, Calcinosis pathology, Calcinosis surgery, Hydrodynamics, X-Ray Microtomography, Prosthesis Design, Transcatheter Aortic Valve Replacement instrumentation, Transcatheter Aortic Valve Replacement adverse effects, Prosthesis Failure, Registries
- Abstract
Background: The etiology of transcatheter aortic valve (TAV) degeneration is poorly understood, particularly noncalcific mechanisms., Objectives: The authors sought to investigate noncalcific and calcific mechanisms of TAV degeneration and evaluate their impact on leaflet function by bench testing, imaging, and histology., Methods: TAV explants were obtained from the EXPLANT THV registry and clinical institutions. Hydrodynamic assessment was performed using a heart valve pulse duplicator system under physiological conditions. Micro-computed tomography, high-resolution photography, high speed video, and hematoxylin and eosin staining were used to evaluate the morphological appearance, leaflet kinematics, and calcium burden of TAVs., Results: A total of 14 explants were evaluated: 10 self-expanding CoreValve/Evolut TAVs (Medtronic), 3 balloon-expandable SAPIEN 3 TAVs (Edwards Lifesciences), and 1 mechanically expandable Lotus TAV (Boston Scientific). The median patient age at explantation was 73.0 years (Q1-Q3: 64.5-80.0 years), with a time to explantation of 4 years 1 month (1 year 5 months to 4 years 11 months). Six TAV explants were found to have leaflet calcification (162.4 mm
3 ; 58.8-603.0 mm3 ), and 8 had no calcification detectable by micro-computed tomography and histology. All samples had impaired leaflet kinematics. There was no significant difference in the hydrodynamic mean gradient between calcified (47.2 mm Hg; 26.6-74.1 mm Hg) and noncalcified (27.6 mm Hg; 15.2-36.7 mm Hg; P = 0.28) TAVs. Leaflet calcification had a weak but nonsignificant association with the hydrodynamic mean gradient (r = 0.42; P = 0.14)., Conclusions: TAV function can be severely impacted by noncalcific and calcific mechanisms of tissue degeneration. Importantly, functional stenosis can occur in TAVs in the absence of obvious and significant calcification., Competing Interests: Funding Support and Author Disclosures This work was supported by Medtronic, USA, and the Cardiovascular Translational Laboratory, Canada. Dr Sathananthan is the chief medical officer for Interventional Cardiology Therapies from Boston Scientific; a consultant to Medtronic and Edwards Lifesciences; has received speaking fees from Edwards Lifesciences, and NVT; and has received research support from Medtronic, Edwards Lifesciences, and Vivitro Labs. Mr Nigade, Dr Spencer, and Mr Navarro are employees and shareholders of Medtronic. Dr Meier has received an institutional grant from Edwards Lifesciences. Dr Pirelli is a consultant and receives speakers honoraria from Medtronic and Edwards Lifesciences. Dr Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott, and ViVitro Labs. Dr Wood is a consultant and receives unrestricted grant support from Medtronic, Edwards Lifesciences, and Abbott Vascular. Dr Lutter is a consultant to Medtronic, Edwards Lifesciences, and Abbott. Dr Puehler is a consultant to Abbott. Dr Tang has received speaker honoraria and served as a physician proctor, consultant, advisory board member, TAVR publications committee member, APOLLO trial screening committee member and IMPACT MR steering committee member for Medtronic, has received speaker honoraria and served as a physician proctor, consultant, advisory board member and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart, has served as an advisory board member for Boston Scientific and JenaValve, a consultant and physician screening committee member for Shockwave Medical, a consultant for NeoChord, Peija Medical and Shenqi Medical Technology, and has received speaker honoraria from Siemens Healthineers. Dr Fukuhara is a consultant for Medtronic, Terumo Aortic, and Artivion. Dr Sellers is a consultant for Medtronic, Edwards Lifesciences, and Anteris; and has received research support from Medtronic, Edwards Lifesciences, Vivitro Labs, and HeartFlow. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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40. The Tricuspid Valve: A Review of Pathology, Imaging, and Current Treatment Options: A Scientific Statement From the American Heart Association.
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Davidson LJ, Tang GHL, Ho EC, Fudim M, Frisoli T, Camaj A, Bowers MT, Masri SC, Atluri P, Chikwe J, Mason PJ, Kovacic JC, and Dangas GD
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- Humans, United States, Heart Valve Diseases therapy, Heart Valve Diseases diagnostic imaging, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency therapy, Heart Valve Prosthesis Implantation, Tricuspid Valve diagnostic imaging, Tricuspid Valve pathology, American Heart Association
- Abstract
Tricuspid valve disease is an often underrecognized clinical problem that is associated with significant morbidity and mortality. Unfortunately, patients will often present late in their disease course with severe right-sided heart failure, pulmonary hypertension, and life-limiting symptoms that have few durable treatment options. Traditionally, the only treatment for tricuspid valve disease has been medical therapy or surgery; however, there have been increasing interest and success with the use of transcatheter tricuspid valve therapies over the past several years to treat patients with previously limited therapeutic options. The tricuspid valve is complex anatomically, lying adjacent to important anatomic structures such as the right coronary artery and the atrioventricular node, and is the passageway for permanent pacemaker leads into the right ventricle. In addition, the mechanism of tricuspid pathology varies widely between patients, which can be due to primary, secondary, or a combination of causes, meaning that it is not possible for 1 type of device to be suitable for treatment of all cases of tricuspid valve disease. To best visualize the pathology, several modalities of advanced cardiac imaging are often required, including transthoracic echocardiography, transesophageal echocardiography, cardiac computed tomography, and cardiac magnetic resonance imaging, to best visualize the pathology. This detailed imaging provides important information for choosing the ideal transcatheter treatment options for patients with tricuspid valve disease, taking into account the need for the lifetime management of the patient. This review highlights the important background, anatomic considerations, therapeutic options, and future directions with regard to treatment of tricuspid valve disease.
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- 2024
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41. Outcomes After Transcatheter Mitral Valve Replacement According to Regurgitation Etiology.
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Perrin N, Ben-Ali W, Ludwig S, Duncan A, Weimann J, Nickenig G, Tanaka T, Coisne A, Vincentelli A, Makkar R, Webb JG, Akodad M, Muller DWM, Jansz P, Praz F, Reineke D, Wild MG, Hausleiter J, Goel SS, Denti P, Chehab O, Dahle G, Baldus S, Ruge H, Kaneko T, Ternacle J, Dumonteil N, von Bardeleben RS, Flagiello M, Walther T, Taramasso M, Søndergaard L, Bleiziffer S, Fam N, Kempfert J, Granada JF, Tang GHL, Conradi L, and Modine T
- Subjects
- Humans, Male, Female, Aged, Treatment Outcome, Aged, 80 and over, Registries, Mitral Valve surgery, Mitral Valve diagnostic imaging, Follow-Up Studies, Retrospective Studies, Middle Aged, Mitral Valve Insufficiency surgery, Mitral Valve Insufficiency etiology, Heart Valve Prosthesis Implantation methods, Heart Valve Prosthesis Implantation adverse effects, Cardiac Catheterization methods
- Abstract
Background: Whether transcatheter mitral valve replacement (TMVR) devices perform similarly with respect to the underlying mitral regurgitation (MR) etiology remains unknown. The aim of the present analysis was to assess outcomes of TMVR according to the MR underlying etiology among the CHoice of OptImal transCatheter trEatment for Mitral Insufficiency (CHOICE-MI) registry., Methods: Of 746 patients, 229 patients (30.7%) underwent TMVR. The study population was subdivided according to primary, secondary, or mixed MR. Patients with mitral annular calcification were excluded. The primary study endpoint was a composite endpoint of all-cause mortality or hospitalization for heart failure at 1 year. Secondary study endpoints were all-cause and cardiovascular mortality at 1 year, New York Heart Association functional class, and residual MR, both at discharge and 1 year., Results: The predominant MR etiology was secondary MR (58.4%), followed by primary MR (28.7%) and mixed MR (12.9%). Technical success and procedural mortality were similar according to MR etiology. Discharge echocardiography revealed residual MR 2+ in 11.3%, 3.7%, and 5.3% of patients with primary, secondary, and mixed MR, respectively (P = .1). MR elimination was similar in all groups up to the 1-year follow-up. There was no difference in terms of primary combined outcome occurrence according to MR etiology. One-year all-cause mortality was reported in 28.8%, 24.2%, and 32.1% of patients with primary, secondary, and mixed MR, respectively (P = .07)., Conclusions: In our study we did not find differences in short-term and 1-year outcomes after TMVR according to MR etiology., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)
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- 2024
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42. A deep dive into the percutaneous mitral valve data.
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Tagliari AP, Saadi RP, and Tang GHL
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- Humans, Mitral Valve surgery, Cardiac Catheterization methods, Treatment Outcome, Multicenter Studies as Topic, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Insufficiency surgery, Mitral Valve Insufficiency complications, Heart Valve Diseases surgery
- Abstract
Purpose of Review: This review offers insights into percutaneous mitral valve management, emphasizing pivotal trials that contributed to its evolution., Recent Findings: Mitral regurgitation (MR) is a highly prevalent heart valve disease, with surgical intervention being the gold standard for managing primary MR. However, a notable proportion of patients face ineligibility criteria or are at high surgical risk, particularly in the setting of secondary MR. To fill this gap, transcatheter therapies have emerged as less invasive alternatives. Initially guided by the EVEREST trial criteria, transcatheter leaflet repair techniques have shown impressive technological improvements, addressing nowadays a wide range of anatomical scenarios. Evidence supporting the safety and efficacy of transcatheter leaflet repair is derived from pivotal trials, including EVEREST II, COAPT, MITRA-FR, and CLASP IID, and large multicenter registries including EXPAND, EXPAND G4, and EuroSMR. However, not all patients meet the anatomical and clinical criteria for leaflet repair. For those patients, transcatheter mitral valve replacement may be a minimally invasive option and multiple clinical trials are current underway., Summary: From MitraClip to newer and more innovative technologies, the landscape of percutaneous mitral valve interventions continues to evolve, offering new hopes to patients who may not be ideal candidates for conventional surgery., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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43. Feasibility of Using TriClip Guide for Combined MitraClip and TriClip Transcatheter Edge-to-Edge Repair: First-in-Human Experience.
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So KC, Kam KK, Tang GHL, and Lee APW
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- Humans, Feasibility Studies, Heart Valve Prosthesis, Prosthesis Design, Recovery of Function, Treatment Outcome, Cardiac Catheterization instrumentation, Heart Valve Prosthesis Implantation instrumentation, Mitral Valve surgery, Mitral Valve diagnostic imaging, Mitral Valve physiopathology, Mitral Valve Insufficiency surgery, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency physiopathology
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- 2024
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44. Computed Tomography Geometry of Extremely Undersized SAPIEN 3 Transcatheter Aortic Valves With Balloon Overfilling.
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Tanner R, Krishnamoorthy P, Tang GHL, Lerakis S, Anastasius M, Hooda A, Dangas GD, Sharma SK, Kini AS, and Khera S
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- 2024
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45. Prediction of Mortality and Heart Failure Hospitalization After Transcatheter Tricuspid Valve Interventions: Validation of TRISCORE.
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Adamo M, Russo G, Pagnesi M, Pancaldi E, Alessandrini H, Andreas M, Badano LP, Braun D, Connelly KA, Denti P, Estevez-Loureiro R, Fam N, Gavazzoni M, Hahn RT, Harr C, Hausleiter J, Himbert D, Kalbacher D, Ho E, Latib A, Lubos E, Ludwig S, Lupi L, Lurz P, Monivas V, Nickenig G, Pedicino D, Pedrazzini G, Pozzoli A, Marafon DP, Pastorino R, Praz F, Rodes-Cabau J, Besler C, Schöber AR, Schofer J, Scotti A, Piayda K, Sievert H, Tang GHL, Sticchi A, Messika-Zeitoun D, Thiele H, Schlotter F, von Bardeleben RS, Webb J, Dreyfus J, Windecker S, Leon M, Maisano F, Metra M, and Taramasso M
- Subjects
- Humans, Cardiac Catheterization methods, Treatment Outcome, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Multicenter Studies as Topic, Registries, Heart Failure diagnosis, Heart Failure therapy, Heart Failure etiology, Heart Valve Prosthesis Implantation, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery
- Abstract
Background: Data on the prognostic role of the TRI-SCORE in patients undergoing transcatheter tricuspid valve intervention (TTVI) are limited., Objectives: The aim of this study was to evaluate the performance of the TRI-SCORE in predicting outcomes of patients undergoing TTVI., Methods: TriValve (Transcatheter Tricuspid Valve Therapies) is a large multicenter multinational registry including patients undergoing TTVI. The TRI-SCORE is a risk model recently proposed to predict in-hospital mortality after tricuspid valve surgery. The TriValve population was stratified based on the TRI-SCORE tertiles. The outcomes of interest were all-cause death and all-cause death or heart failure hospitalization. Procedural complications and changes in NYHA functional class were also reported., Results: Among the 634 patients included, 223 patients (35.2%) had a TRI-SCORE between 0 and 5, 221 (34.8%) had 6 or 7, and 190 (30%) had ≥8 points. Postprocedural blood transfusion, acute kidney injury, new atrial fibrillation, and in-hospital mortality were more frequent in the highest TRI-SCORE tertile. Postprocedure length of stay increased with a TRI-SCORE increase. A TRI-SCORE ≥8 was associated with an increased risk of 30-day all-cause mortality and all-cause mortality and the composite endpoint assessed at a median follow-up of 186 days (OR: 3.00; 95% CI: 1.38-6.55; HR: 2.17; 95% CI: 1.78-4.13; HR: 2.08, 95% CI: 1.57-2.74, respectively) even after adjustment for procedural success and EuroSCORE II or Society of Thoracic Surgeons Predicted Risk of Mortality. The NYHA functional class improved across all TRI-SCORE values., Conclusions: In the TriValve registry, the TRI-SCORE has a suboptimal performance in predicting clinical outcomes. However, a TRISCORE ≥8 is associated with an increased risk of clinical events and a lack of prognostic benefit after successful TTVI., Competing Interests: Funding Support and Author Disclosures Dr Adamo has received speaker honoraria from Abbott. Dr Russo has received a fellowship training grant from the EAPCI sponsored by Edwards Lifesciences. Dr Badano is on the Speaker Bureau of GE Healthcare, Philips Medical Systems, and EsaOte SpA; is currently serving on the Clinical Event Committee of Edwards Lifesciences; and is the director of the echocardiography core laboratory at the Istituto Auxologico Italiano, IRCCS for multiple industry-sponsored trials for which he receives no direct industry compensation. Dr Andreas is a proctor/consultant/speaker for Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, Zoll; and has received institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences. Dr Estevez-Loureiro is a consultant for Abbott Vascular, Boston Scientific, and Edwards Lifesciences. Dr Gavazzoni is a proctor for Abbott. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; has stock options with Navigate; and is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials for which she receives no direct industry compensation. Dr Nickenig has received honoraria for lectures or advisory boards from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Schofer is a consultant for Edwards Lifesciences. Dr Sievert has received study honoraria to institution, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Adona Medical, Akura Medical, Ancora Heart, Append Medical, Axon, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Cardiac Dimensions, Cardiac Success, Cardimed, Cardionovum, Celonova, Contego, Coramaze, Croivalve, CSL Behring LLC, CVRx, Dinova, Edwards Lifesciences, Endobar, Endologix, Endomatic, Esperion Therapeutics, Inc, Hangzhou Nuomao Medtech, Holistick Medical, Intershunt, Intervene, K2, Laminar, Lifetech, Magenta, Maquet Getinge Group, Metavention, Mitralix, Mokita, Neurotronic, NXT Biomedical, Occlutech, Recor, Renal Guard, Shifamed, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, Vivasure Medical, Vvital Biomed, and Whiteswell. Dr Tang has served as a physician proctor for Medtronic; has served as a consultant for Medtronic, Abbott Structural Heart, and NeoChord; has served on the TAVR Advisory Board for Abbott Structural Heart; and has served on the Physician Advisory Board for JenaValve. Dr von Bardeleben has served for trials and principal investigator for Abbott, Edwards Lifesciences, and Medtronic. Dr Windecker has received research, travel, or educational grants to the institution from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as an Advisory Board member and/or member of the Steering/Executive Group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave, and Xeltis with payments to the institution but no personal payments; and is a member of the Steering/Executive Committee Group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Maisano is a consultant for Abbott Vascular, Medtronic, Edwards Lifesciences, Perifect, Xeltis, Transseptal Solutions, Magenta, and Cardiovalve; has received grant support from Abbott Vascular, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received royalties from Edwards Lifesciences and 4Tech; and is cofounder/shareholder of Transseptal Solutions, 4Tech, Cardiovalve, Magenta, Perifect, Coregard, and SwissVortex. Dr Metra has received consulting fees from Abbott Vascular, Actelion, Amgen, AstraZeneca, Bayer, Edwards Therapeutics, Livanova, Servier, Vifor Pharma, and WindTree Therapeutics. Dr Taramasso has received consultancy fees from Abbott Vascular, Edwards Lifesciences, 4Tech, Boston Scientific, CoreMedic, Mitraltech, and SwissVortex outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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46. Fundamental Roles of Intracardiac Echocardiography and Fluoroscopy in Redo Tricuspid Transcatheter Edge-to-Edge Repair Procedure.
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Passaniti G, Safi LM, Prandi F, Ratanapo S, Lerakis S, Tang GHL, and Krishnamoorthy P
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- Humans, Treatment Outcome, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Echocardiography, Fluoroscopy, Cardiac Catheterization methods, Tricuspid Valve Insufficiency surgery, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation methods
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Tang is a physician proctor, consultant, and Physician Advisory Board member for Medtronic; is a consultant and Physician Advisory Board member for Abbott Structural Heart; is a Physician Advisory Board member for JenaValve and Boston Scientific; and has received speaker honoraria for Siemens Healthineers. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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- 2024
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47. Commissural vs Coronary Alignment to Avoid Coronary Overlap With THV-Commissure in TAVR: A CT-Simulation Study.
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Vinayak M, Tang GHL, Li K, Berdan M, Koshy AN, Khera S, Lerakis S, Dangas GD, Sharma SK, Kini AS, and Krishnamoorthy P
- Subjects
- Humans, Aortic Valve diagnostic imaging, Aortic Valve surgery, Treatment Outcome, Multidetector Computed Tomography, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement methods, Heart Valve Prosthesis
- Abstract
Background: Coronary alignment is proposed as an alternative to commissural alignment for reducing coronary overlap during transcatheter aortic valve replacement (TAVR). However, largescale studies are lacking., Objectives: This study aimed to determine the incidence of coronary overlap with commissural vs coronary alignment using computed tomography (CT) simulation in patients undergoing TAVR evaluation., Methods: In 1,851 CT scans of native aortic stenosis patients undergoing TAVR evaluation (April 2018 to December 2022),virtual valves simulating commissural and coronary alignment were superimposed on axial aortic root images. Coronary overlap was assessed based on the angular gap between coronary artery origin and the nearest transcatheter heart valve commissure, categorized as severe (≤15°), moderate (15°-30°), mild (30°-45°), and no-overlap (45°-60°)., Results: The overall incidence of moderate/severe and severe overlap with either coronary artery remained rare with either coronary or commissural alignment (coronary 0.52% left, 0.52% right; commissural 0.30% left, 3.27% right). Comparing techniques, coronary alignment reduced moderate/severe overlap only for the right coronary artery (0.38% vs 2.97%; P <0.0001). For the left coronary artery, both techniques showed similar moderate/severe overlap, but commissural alignment had significantly higher no-overlap rates (91.1% vs 84.9%; P < 0.0001). Fluoroscopic angle during valve deployment was strongly correlated between commissural and coronary alignment (r = 0.80; P < 0.001)., Conclusions: Using CT simulation, the incidence of coronary overlap with transcatheter heart valve-commissure is rare with commissural alignment. Coronary alignment reduced right coronary overlap, whereas commissural alignment had higher rates of no left coronary overlap. Coronary alignment should be reserved only when commissural alignment results in severe coronary overlap., Competing Interests: Funding Support and Author Disclosures Dr Koshy is supported by a postdoctoral fellowship from the Heart Foundation of Australia. Dr Tang is a proctor for Medtronic; a consultant for Medtronic, Abbott Structural Heart, and NeoChord; advisory board member for Medtronic, Abbott Structural Heart, Boston Scientific, and JenaValve; and has received speaker honoraria from Siemens Healthineers. Dr Khera is a consultant for Abbott Structural Heart, Terumo, Eastend Medical, Medtronic, and W.L. Gore; is a proctor for Medtronic; and serves on the speaker board for Zoll Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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48. Real-World Experience of Transcatheter Mitral Valve Replacement: A Promising Glimpse Into the Future?
- Author
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Zaid S and Tang GHL
- Subjects
- Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Treatment Outcome, Cardiac Catheterization adverse effects, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery, Heart Valve Prosthesis Implantation adverse effects
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Tang is a physician proctor, consultant, and Advisory Board member for Medtronic; is a consultant and Advisory Board member for Abbott Structural Heart; is an advisory board member for Boston Scientific and JenaValve; and has received speaker honoraria from Siemens Healthineers. Dr Zaid has reported that he has no relationships relevant to the contents of this paper to disclose.
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- 2024
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- View/download PDF
49. Redo-TAVR Feasibility After SAPIEN 3 Stratified by Implant Depth and Commissural Alignment: A CT Simulation Study.
- Author
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Koshy AN, Tang GHL, Khera S, Vinayak M, Berdan M, Gudibendi S, Hooda A, Safi L, Lerakis S, Dangas GD, Sharma SK, Kini AS, and Krishnamoorthy P
- Subjects
- Humans, Aged, Aged, 80 and over, Aortic Valve diagnostic imaging, Aortic Valve surgery, Feasibility Studies, Prosthesis Design, Treatment Outcome, Tomography, X-Ray Computed, Risk Factors, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement methods, Heart Valve Prosthesis, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery
- Abstract
Background: Redo-transcatheter aortic valve replacement (TAVR) can pin the index transcatheter heart valve leaflets open leading to sinus sequestration and restricting coronary access. The impact of initial implant depth and commissural alignment on redo-TAVR feasibility is unclear. We sought to determine the feasibility of redo-TAVR and coronary access after SAPIEN 3 (S3) TAVR stratified by implant depth and commissural alignment., Methods: Consecutive patients with native valve aortic stenosis were evaluated using multidetector computed tomography. S3 TAVR simulations were done at 3 implant depths, sizing per manufacturer recommendation and assuming nominal expansion in all cases. Redo-TAVR was deemed unfeasible based on valve-to-sinotubular junction distance and valve-to-sinus height <2 mm, while the neoskirt plane of the S3 transcatheter heart valve estimated coronary access feasibility., Results: Overall, 1900 patients (mean age, 80.2±8 years; STS-PROM [Society of Thoracic Surgeons Predicted Risk of Operative Mortality], 3.4%) were included. Redo-TAVR feasibility reduced significantly at shallower initial S3 implant depths (2.3% at 80:20 versus 27.5% at 100:0, P <0.001). Larger S3 sizes reduced redo-TAVR feasibility, but only in patients with a 100:0 implant ( P <0.001). Commissural alignment would render redo-TAVR feasible in all patients, assuming the utilization of leaflet modification techniques to reduce the neoskirt height. Coronary access following TAV-in-TAV was affected by both index S3 implant depth and size., Conclusions: This study highlights the critical impact of implant depth, commissural alignment, and transcatheter heart valve size in predicting redo-TAVR feasibility. These findings highlight the necessity for individualized preprocedural planning, considering both immediate results and long-term prospects for reintervention as TAVR is increasingly utilized in younger patients with aortic stenosis., Competing Interests: Dr Koshy is supported by a postdoctoral scholarship from the Heart Foundation of Australia. Dr Khera is a speaker for Medtronic and Zoll Medical; a proctor for Medtronic; and a consultant for Terumo, Medtronic, Abbott, and Boston Scientific. Dr Tang is a physician proctor for Medtronic; a consultant for Medtronic, Abbott Structural Heart, and NeoChord; a physician advisory board member for Abbott Structural Heart, Boston Scientific, and JenaValve; and receives speaker’s honoraria from Siemens Healthineers. The other authors report no conflicts.
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- 2024
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50. Impact of Tricuspid Regurgitation on Outcomes of Mitral Valve Surgery after Transcatheter Edge-to-Edge Repair.
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Zaid S, Denti P, Tang GHL, Nazif TN, Bapat VN, Kaneko T, and Modine T
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- Humans, Middle Aged, Aged, Aged, 80 and over, Mitral Valve diagnostic imaging, Mitral Valve surgery, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Treatment Outcome, Retrospective Studies, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery, Heart Valve Prosthesis Implantation adverse effects
- Abstract
Tricuspid regurgitation (TR) severity after mitral transcatheter edge-to-edge repair (TEER) has been shown to impact outcomes but unknown in patients requiring mitral valve (MV) surgery after TEER. We sought to determine the impact of preoperative TR severity and right ventricular (RV) dysfunction on MV surgery after TEER. From 7/2009 to 7/2020, 260/332 patients in the CUTTING-EDGE registry who underwent MV surgery after TEER had paired echocardiographic evaluation on TR severity, and ≥moderate (2+) vs <2+ TR at the time of index TEER were compared. Median follow-up post-MV surgery was 9.1 months, 96.5% complete at 30 days and 81.9% complete at 1 year. Mean age was 73.8 ± 10.3; with primary/mixed and secondary MR present in 65.6% and 32.0%, respectively. Proportion of ≥2+ TR increased from TEER to MV surgery (40% vs 57%, P < 0.001). Compared to <2+ TR group, ≥2+ pre-TEER TR patients were older, had higher STS risk score at TEER, higher RVSP, more RV dysfunction, more MR post-TEER, and a shorter median interval from TEER to MV surgery (1.9 vs 4.9 months, P = 0.023). Mortality was higher in the ≥2+ pre-TEER TR group at 30 days(24.2% vs 13.8%, P = 0.043) and 1 year (45.3% vs 22.3%, P = 0.003). On Kaplan-Meier analysis, cumulative mortality was 23.8% at 1 year and 31.6% at 3 years after MV surgery overall, and was associated with preoperative RV dysfunction (P = 0.023), ≥2+ TR at pre-TEER (P = 0.001) and presurgery (P = 0.004), but not concomitant tricuspid surgery. Moderate or greater pre-TEER TR was associated with worse outcomes, and pre-TEER TR worsened significantly at MV surgery. Concomitant tricuspid surgery did not increase overall mortality., (Copyright © 2022 Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
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