80 results on '"Alessandrini H"'
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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. Echocardiography and computed tomography predictors of successful transcatheter direct annuloplasty for mitral regurgitation
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Iliadis, C, primary, Weber, M, additional, Horn, P, additional, Harr, C, additional, Gavazzoni, M, additional, Nickenig, G, additional, Westenfeld, R, additional, Alessandrini, H, additional, Taramasso, M, additional, Baldus, S, additional, and Pfister, R, additional
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- 2022
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4. Zukünftige interventionelle Verfahren bei Herzklappenerkrankungen
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Thielsen, T., Frerker, C., Schmidt, T., Schlüter, M., Kreidel, F., Alessandrini, H., and Kuck, K.-H.
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- 2016
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5. Bildgebung bei interventionellen Mitralklappeneingriffen
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Kreidel, F., Alessandrini, H., Frerker, C., Thielsen, T., Schäfer, U., and Kuck, K.H.
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- 2013
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6. NACA-Scoringsystem: Eine retro- und prospektive Validitätsanalyse anhand ausgewählter Diagnosegruppen
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Alessandrini, H., Oberladstätter, D., Trimmel, H., Jahn, B., and Baubin, M.
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- 2012
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7. 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
8. Impact of intervention strategies after failed Mitraclip therapy on mid-term outcome
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Alessandrini, H, primary, Geidel, S, additional, Wohlmuth, P, additional, Meincke, F, additional, Hakmi, S, additional, Gosau, N, additional, Ubben, T, additional, Kuck, K.H, additional, and Willems, S, additional
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- 2020
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9. Mid-Term Results of Surgery in Patients with Unsuccessful MitraClip Implants for Degenerative Mitral Valve Disease
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Geidel, S., additional, Hassan, K., additional, Alessandrini, H., additional, Wohlmuth, P., additional, Caspary, M., additional, Bein, B., additional, and Schmoeckel, M., additional
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- 2020
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10. Multicenter Experience With Treatment of Residual Mitral Regurgitation After MitraClip Implantation Using Amplatzer Closure Device: Mid-Term Results
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Taramasso M, Alessandrini H, Kuwata S, Biasco L, Nietlispach F, Gaemperli O, Zuber M, Linka A, Pedrazzini G, Kreidel F, Frerker C, Kuck KH, Maisano F, Taramasso, M, Alessandrini, H, Kuwata, S, Biasco, L, Nietlispach, F, Gaemperli, O, Zuber, M, Linka, A, Pedrazzini, G, Kreidel, F, Frerker, C, Kuck, Kh, and Maisano, F
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- 2017
11. The International Multicenter TriValve Registry: Which Patients Are Undergoing Transcatheter Tricuspid Repair?
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Taramasso M, Hahn RT, Alessandrini H, Latib A, Attinger-Toller A, Braun D, Brochet E, Connelly KA, Denti P, Deuschl F, Englmaier A, Fam N, Frerker C, Hausleiter J, Juliard JM, Kaple R, Kreidel F, Kuck KH, Kuwata S, Ancona M, Malasa M, Nazif T, Nickenig G, Nietlispach F, Pozzoli A, Schafer U, Schofer J, Schueler R, Tang G, Vahanian A, Webb JG, Yzeiraj E, Maisano F, Leon MB, Taramasso, M, Hahn, Rt, Alessandrini, H, Latib, A, Attinger-Toller, A, Braun, D, Brochet, E, Connelly, Ka, Denti, P, Deuschl, F, Englmaier, A, Fam, N, Frerker, C, Hausleiter, J, Juliard, Jm, Kaple, R, Kreidel, F, Kuck, Kh, Kuwata, S, Ancona, M, Malasa, M, Nazif, T, Nickenig, G, Nietlispach, F, Pozzoli, A, Schafer, U, Schofer, J, Schueler, R, Tang, G, Vahanian, A, Webb, Jg, Yzeiraj, E, Maisano, F, and Leon, Mb
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- 2017
12. P6491Predictive effect of mitral annular size on persistent mitral valve dysfunction after transcatheter edge-to-edge mitral valve repair for functional mitral regurgitation
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Kitamura, M, primary, Schmidt, T, additional, Schewel, D, additional, Alessandrini, H, additional, Kuck, K.-H, additional, and Frerker, C, additional
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- 2019
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13. P2582Impact of left circumflex coronary artery disease on outcomes after successful transcatheter mitral valve repair using the MitraClip for ischaemic functional mitral regurgitation
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Kitamura, M, primary, Schmidt, T S, additional, Schlueter, M S, additional, Schewel, D S, additional, Alessandrini, H A, additional, Kreidel, F K, additional, Kuck, K H K, additional, and Frerker, C F, additional
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- 2018
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14. P4827Wide area left atrial appendage isolation in patients non responding to pulmonary vein isolation: Benefit, risk and prevention of thromboembolism
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Heeger, C H, primary, Rillig, A, additional, Geisler, D, additional, Fink, T, additional, Mathew, S, additional, Tilz, R R, additional, Reissmann, B, additional, Lemes, C, additional, Maurer, T, additional, Santoro, F, additional, Alessandrini, H, additional, Dotz, I, additional, Metzner, A, additional, Kuck, K H, additional, and Ouyang, F, additional
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- 2018
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15. P1754Anatomical, morphological, and haemodynamic predictors of transmitral pressure gradient greater than or equal to 5 mmHg after MitraClip implantation
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Alessandrini, H, primary, Kreidel, F, additional, Wohlmuth, P, additional, Schlueter, M, additional, Schewel, J, additional, Schewel, D, additional, Schmidt, T, additional, Frerker, C, additional, and Kuck, K H, additional
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- 2018
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16. 520Wide area left atrial appendage isolation for atrial fibrillation therapy: Long-term succes and incidence of stroke and thrombus formation
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Heeger, C H, primary, Rillig, A, additional, Tilz, R R, additional, Fink, T, additional, Mathew, S, additional, Reissmann, B, additional, Lemes, C, additional, Maurer, T, additional, Santoro, F, additional, Inaba, O, additional, Alessandrini, H, additional, Dotz, I, additional, Metzner, A, additional, Kuck, K H, additional, and Ouyang, F, additional
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- 2018
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17. Use of Fibrin Sealant in Paediatric Surgery
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Alessandrini, H., Pineschi, A., Giannotta, A., Schlag, Günther, editor, and Redl, Heinz, editor
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- 1986
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18. Hemodynamic Differences in Three Aortic Bioprostheses and the Correlation to Early BNP Alterations as a Marker for Myocardial Recovery
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Bayer, N., primary, Oberhoffer, M., additional, Alessandrini, H., additional, Kreidel, F., additional, Jensen, F., additional, Bader, R., additional, Geidel, S., additional, and Schmoeckel, M., additional
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- 2015
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19. NACA-Scoringsystem
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Alessandrini, H., primary, Oberladstätter, D., additional, Trimmel, H., additional, Jahn, B., additional, and Baubin, M., additional
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- 2010
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20. NACA-Scoringsystem.
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Alessandrini, H., Oberladstätter, D., Trimmel, H., Jahn, B., and Baubin, M.
- Abstract
Copyright of Notfall & Rettungsmedizin is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2012
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21. 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
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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.
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- 2019
22. 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
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- Humans, Risk Assessment, Male, Female, Risk Factors, Aged, Time Factors, Aged, 80 and over, Treatment Outcome, Reproducibility of Results, Clinical Decision-Making, Middle Aged, Predictive Value of Tests, Registries, Tricuspid Valve physiopathology, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Patient Readmission, Tricuspid Valve Insufficiency mortality, Tricuspid Valve Insufficiency physiopathology, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery, 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, Severity of Illness Index
- 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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- 2024
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23. Mitral regurgitation evolution after transcatheter tricuspid valve interventions - a sub-analysis of the TriValve Registry.
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Cannata F, Sticchi A, Russo G, Stankowski K, Hahn RT, Alessandrini H, Andreas M, Braun D, Connelly KA, Denti P, Estevez-Loureiro R, Fam N, Harr C, Hausleiter J, Himbert D, Kalbacher D, Adamo M, Latib A, Lubos E, Ludwig S, Lurz P, Monivas V, Nickenig G, Pedrazzini G, Pozzoli A, Praz F, Rodes-Cabau J, Rommel KP, Schofer J, Sievert H, Tang G, Thiele H, Kresoja KP, Metra M, Stephan von Bardeleben R, Webb J, Windecker S, Leon M, Maisano F, De Marco F, Pontone G, and Taramasso M
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Aims: Transcatheter tricuspid valve interventions (TTVI) are increasingly used to treat patients with significant tricuspid regurgitation (TR). The evolution of concurrent mitral regurgitation (MR) severity after TTVI is currently unknown and may be pivotal for clinical decision-making. The aim of this study was to assess the evolution of MR after TTVI and to identify predictors of MR worsening and improvement., Methods and Results: This analysis is a substudy of the Trivalve Registry, an international registry designed to collect data on TTVI. This substudy included all patients with echocardiographic data on MR evolution and excluded those with a concomitant tricuspid and mitral transcatheter valve intervention or with a history of mitral valve intervention. The co-primary outcomes were MR improvement and worsening at two timepoints: pre-discharge and 2-month follow-up. This analysis included 359 patients with severe TR, mostly(80%) treated with tricuspid transcatheter edge-to-edge repair(T-TEER). MR improvement was found in 106(29.5%) and 99(34%) patients, while MR worsening in 34(9.5%) and 33(11%) patients at pre-discharge and 2-month follow-up, respectively. Annuloplasty and heterotopic replacement were associated with MR worsening. Independent predictors of MR improvement were: atrial fibrillation, T-TEER, acute procedural success, TR reduction, LVEDD>60 mm and beta-blocker therapy. Patients with moderate-to-severe/severe MR following TTVI showed significantly higher death rates., Conclusion: MR degree variation is common after TTVI, with most cases showing improvement. Clinical and procedural characteristics may predict the MR evolution, in particular procedural success and T-TEER play key roles in MR outcomes. TTVI may be beneficial even in the presence of functional MR., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2024
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24. 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
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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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25. Effects of tricuspid transcatheter edge-to-edge repair on tricuspid annulus diameter - Data from the TriValve registry.
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Russo G, Hahn RT, Alessandrini H, Andreas M, Badano LP, Braun D, Connelly KA, Denti P, Estevez-Loureiro R, Fam N, Gavazzoni M, Hausleiter J, Himbert D, Kalbacher D, Latib A, Lubos E, Ludwig S, Lurz P, Monivas V, Nickenig G, Pedicino D, Pedrazzini G, Pozzoli A, Praz F, Rodes-Cabau J, Rommel KP, Schofer J, Sievert H, Tang G, Thiele H, Unterhuber M, von Bardeleben RS, Webb J, Windecker S, Leon M, Maisano F, and Taramasso M
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- Humans, Male, Female, Aged, Aged, 80 and over, Treatment Outcome, Heart Valve Prosthesis Implantation methods, Middle Aged, Echocardiography methods, Registries, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Tricuspid Valve Insufficiency surgery, Tricuspid Valve Insufficiency diagnostic imaging, Cardiac Catheterization methods
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Aims: T-TEER is an effective therapy for the treatment of tricuspid regurgitation (TR). However, the effects of leaflets clipping on tricuspid valve annulus (TA) have not been investigated in detail. The aim of this study is to investigate the effects of tricuspid transcatheter edge-to-edge repair (T-TEER) on TA diameter., Methods and Results: The TriValve registry (Transcatheter Tricuspid Valve Therapies, NCT03416166) collected 556 patients from 22 European and North American centres undergoing transcatheter tricuspid valve interventions from 2016 to 2022. Patients undergoing T-TEER with available pre- and post-procedural data on TA diameter measured in the apical 4-chamber view on transthoracic echocardiography were selected for this study. Primary end-point was the reduction of TA diameter after T-TEER. A total of 186 patients were included in the study. In 115 patients (62%) TA diameter was reduced by at least 1 mm as compared to baseline. A significant reduction of TA dimension was observed following T-TEER (mean 2.3 mm [from pre-procedural diameter 46.7 mm to post-procedural diameter 44.4 mm], p < 0.001). In particular, the greatest reduction was observed in those with T-TEER in antero-septal commissure (mean 2.7 mm [from 47.1 mm to 44.4 mm], p < 0.001) as compared to those combining both antero-septal and postero-septal commissures (mean 1.4, from 46.0 mm to 44.6 mm, P = 0.06). A significant reduction of TA dimension was recorded in patients with 1 or 2 clips implanted but not in those patients with ≥3 clips implanted., Conclusions: In almost two third of patients T-TEER reduces TA diameter in addition to leaflet approximation., Condensed Abstract: The effects of tricuspid transcatheter edge-to-edge repair (T-TEER) on tricuspid valve annulus (TA) have not been studied in details. This study investigates TA diameter as measured in apical 4-chamber view on transthoracic echocardiography before and after T-TEER. A total of 186 patients from the TriValve registry were included in the study. The study results show that 62% of patients have a TA reduction after T-TEER, especially in those receiving 1 or 2 clips in the antero-septal commissure. These suggest that T-TEER reduces tricuspid regurgitation not only by approximation of leaflets, but also by TA diameter reduction., (Copyright © 2024 Elsevier B.V. All rights reserved.)
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- 2024
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26. Association of pulmonary hypertension with the outcome in patients undergoing edge-to-edge mitral valve repair.
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Ubben T, Frerker C, Fujita B, Rosenkranz S, Pfister R, Baldus S, Alessandrini H, Kuck KH, Willems S, Eitel I, and Schmidt T
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- Humans, Female, Male, Retrospective Studies, Aged, Treatment Outcome, Mitral Valve diagnostic imaging, Mitral Valve physiopathology, Mitral Valve surgery, Pulmonary Wedge Pressure physiology, Middle Aged, Risk Factors, Hemodynamics physiology, Hypertension, Pulmonary physiopathology, Hypertension, Pulmonary mortality, Hypertension, Pulmonary diagnosis, Mitral Valve Insufficiency surgery, Mitral Valve Insufficiency physiopathology, Mitral Valve Insufficiency mortality, Mitral Valve Insufficiency diagnosis, Mitral Valve Insufficiency complications, Cardiac Catheterization methods
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Objectives: The association of pulmonary hypertension (PH) with the outcome after mitral transcatheter edge-to-edge repair (M-TEER) focusing on the new ESC/ERS guidelines definition for PH., Background: PH is frequently found in patients with mitral regurgitation and is associated with lower survival rates. Recent studies were based on echocardiographic parameters, but results based on invasive haemodynamics differentiating distinct types of PH using the new definition for PH are missing., Methods: 449 consecutive M-TEER-treated patients from December 2009 to February 2015 were included in this retrospective analysis. All patients were stratified by the distinct types of PH (no PH, precapillary PH, isolated postcapillary PH, combined post-PH and precapillary PH) according to the definitions of the ESC/ERS guidelines for the diagnosis of PH from 2015 (meanPA cut-off <25 mm Hg, pulmonary capillary wedge pressure (PCWP) cut-off ≤15 mm Hg, diastolic pulmonary gradient cut-off ≥7 mm Hg or pulmonary vascular resistance (PVR) >3 WU) and 2022 (meanPA cut-off ≤20 mm Hg, PCWP cut-off ≤15 mm Hg, PVR cut-off ≥3 WU)., Results: Patients with any type of PH (2015: meanPA cut-off 25 mm Hg; 2022: meanPA cut-off >20 mm Hg) showed a higher risk of death after M-TEER compared with patients with no PH (2015: HR 1.61 (95% CI 1.25 to 2.07); p<0.001 and 2022: HR 2.09 (95% CI 1.54 to 2.83); p<0.001). Based on the new PH definition, each PH subgroup showed a lower survival after M-TEER compared with patients with no PH. Echocardiographic estimated systolic PAP showed a correlation with invasively measured mean pulmonary artery pressure (mPAP) (r=0.29, p<0.001) and systolic pulmonary arterial pressure (r=0.34,p<0.001). Cox-regression analysis showed higher invasive diastolic, systolic and mean pulmonary pressures were associated with higher all-cause mortality (p<0.001). In addition, invasive measured higher right atrial pressure, lower pulmonary arterial compliance, higher PVR and higher wedge pressure were identified as predictors of all-cause mortality after M-TEER., Conclusions: The new PH definition discriminates PH groups and mortality better than the old definition. The lower threshold of mPAP of 20mmHg improved prognostication in this cohort of patients., Competing Interests: Competing interests: TU, BF, K-HK and SR declare the full disclosure of any relationship with industry. IE received lecture honoraria and research grants by Abbott and lecture honoraria by Edwards. HA received travel support by Abbott. T. Schmidt, S. Willems, CF received lecture honoraria and travel support from Abbott Vascular and Edwards Lifesciences. RP received lecture honoraria from Abbott Vascular and Edwards and is a consultant for Edwards. SB received lecture honoraria and research grants from Edwards and Abbott., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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27. 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
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- 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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28. Imaging Predictors of Successful Transcatheter Direct Annuloplasty in Secondary Mitral Regurgitation.
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Iliadis C, Weber M, Horn P, Harr C, Gavazzoni M, Nickenig G, Westenfeld R, Taramasso M, Alessandrini H, and Pfister R
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- Humans, Treatment Outcome, Mitral Valve diagnostic imaging, Mitral Valve surgery, Cardiac Catheterization methods, Tricuspid Valve surgery, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery, Mitral Valve Annuloplasty adverse effects, Mitral Valve Annuloplasty methods, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation methods
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- 2023
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29. 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 LP, Adamo M, Alessandrini H, Andreas M, 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, Lurz P, Monivas V, Nickenig G, Pedicino D, Pedrazzini G, Pozzoli A, Pires Marafon D, Pastorino R, Praz F, Rodes-Cabau J, Besler C, Schofer J, Scotti A, Piayda K, Sievert H, Tang GHL, Thiele H, Schlotter F, von Bardeleben RS, Webb J, Windecker S, Leon M, Maisano F, Metra M, and Taramasso M
- Subjects
- Humans, Stroke Volume, Treatment Outcome, Cardiac Catheterization methods, Ventricular Function, Left, Registries, Tricuspid Valve Insufficiency complications, Tricuspid Valve Insufficiency surgery, Heart Valve Prosthesis Implantation methods, Heart Failure etiology
- 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., (© 2023 European Society of Cardiology.)
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- 2023
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30. Prognostic Value of Tricuspid Valve Gradient After Transcatheter Edge-to-Edge Repair: Insights From the TriValve Registry.
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Coisne A, Scotti A, Taramasso M, Granada JF, Ludwig S, Rodés-Cabau J, Lurz P, Hausleiter J, Fam N, Kodali SK, Pozzoli A, Alessandrini H, Biasco L, Brochet E, Denti P, Estevez-Loureiro R, Frerker C, Ho EC, Monivas V, Nickenig G, Praz F, Puri R, Sievert H, Tang GHL, Andreas M, Von Bardeleben RS, Rommel KP, Muntané-Carol G, Gavazzoni M, Braun D, Lubos E, Kalbacher D, Connelly KA, Juliard JM, Harr C, Pedrazzini G, Philippon F, Schofer J, Thiele H, Unterhuber M, Himbert D, Alcázar MU, Wild MG, Jorde U, Windecker S, Maisano F, Leon MB, Hahn RT, and Latib A
- Abstract
Background: Data regarding the impact of the tricuspid valve gradient (TVG) after tricuspid transcatheter edge-to-edge repair (TEER) are scarce., Objectives: This study sought to evaluate the association between the mean TVG and clinical outcomes among patients who underwent tricuspid TEER for significant tricuspid regurgitation., Methods: Patients with significant tricuspid regurgitation who underwent tricuspid TEER within the TriValve (International Multisite Transcatheter Tricuspid Valve Therapies) registry were divided into quartiles based on the mean TVG at discharge. The primary endpoint was the composite of all-cause mortality and heart failure hospitalization. Outcomes were assessed up to the 1-year follow-up., Results: A total of 308 patients were included from 24 centers. Patients were divided into quartiles of the mean TVG as follows: quartile 1 (n = 77), 0.9 ± 0.3 mm Hg; quartile 2 (n = 115), 1.8 ± 0.3 mm Hg; quartile 3 (n = 65), 2.8 ± 0.3 mm Hg; and quartile 4 (n = 51), 4.7 ± 2.0 mm Hg. The baseline TVG and the number of implanted clips were associated with a higher post-TEER TVG. There was no significant difference across TVG quartiles in the 1-year composite endpoint (quartiles 1-4: 35%, 30%, 40%, and 34%, respectively; P = 0.60) or the proportion of patients in New York Heart Association class III to IV at the last follow-up (P = 0.63). The results were similar after adjustment for clinical and echocardiographic characteristics (composite endpoint quartile 4 vs quartile 1-quartile 3 adjusted HR: 1.05; 95% CI: 0.52-2.12; P = 0.88) or exploring post-TEER TVG as a continuous variable., Conclusions: In this retrospective analysis of the TriValve registry, an increased discharge TVG was not significantly associated with adverse outcomes after tricuspid TEER. These findings apply for the explored TVG range and up to the 1-year follow-up. Further investigations on higher gradients and longer follow-up are needed to better guide the intraprocedural decision-making process., Competing Interests: Funding Support and Author Disclosures Dr Coisne has served as a consultant for Abbott; and has received speaker fees from Abbott and GE Healthcare. Dr Scotti has served as a consultant for NeoChord Inc; and has received consulting fees from NeoChord Inc. Dr Taramasso has served as a consultant for Abbott Vascular, Boston Scientific, 4Tech, and CoreMedic; and has received speaker honoraria from Edwards Lifesciences. Dr Ludwig has received travel compensation from Edwards Lifesciences. Dr Rodés-Cabau has received institutional research grants from Edwards Lifesciences. Dr Lurz has received speaker fees from Abbott. Dr Hausleiter has received speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr Kodali has served on the scientific advisory board for Microinterventional Devices, Dura Biotech, Thubrikar Aortic Valve, and Supira; has served as a consultant for Meril Lifesciences, Admedus, Medtronic, and Boston Scientific; has served on the steering committee for Edwards Lifesciences and Abbott Vascular; has received honoraria from Meril Lifesciences, Admedus, Abbott Vascular, and Dura Biotech; and owns equity in Dura Biotech, Thubrikar Aortic Valve, Supira, and MID. Dr Alessandrini has received consulting fees from Abbott and Edwards LifeSciences. Dr Brochet has received speaker fees from Abbott Vascular. Dr Denti has served as a consultant for Abbott Vascular, 4Tech, Neovasc, and InnovHeart; and has received honoraria from Abbott and Edwards Lifesciences. Dr Estévez- Loureiro has received speaker fees from Abbott, Boston, and Edwards Lifesciences. Dr Ho has served as a consultant for NeoChord Inc; and has received consulting fees from NeoChord Inc. Dr Praz has received travel expenses from Edwards Lifesciences, Abbott Vascular, and Polares Medical. Dr Sievert has received study honoraria, travel expenses, and consulting fees from 4Tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed BV, Contego, CVRx, Edwards Lifesciences, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, PFM Medical, ReCor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, and Vivasure Medical. Dr Tang has served as a consultant, physician advisory board member, and faculty trainer for Abbott Structural Heart; has served as a consultant for Medtronic and NeoChord; and has served as a physician advisory board member for JenaValve. Dr Andreas has served as a proctor/consultant for and has received speaker fees from Abbott, Edwards LifeSciences, Boston, Zoll and Medtronic; and has received institutional grants from Edwards Lifesciences, Abbott, Medtronic, and LSI Solutions. Dr Gavazzoni has served as a consultant for Abbott Vascular. Dr Braun has received speaker honoraria and travel support from Abbott Vascular. Dr Lubos has received grant support and lecture fees from Abbott; and has received lecture fees from Edwards Lifesciences. Dr Kalbacher has received lecture fees from Abbott and Edwards Lifesciences. Dr Connelly has received honoraria from Abbott. Dr Schofer has served as a consultant for Edwards Lifesciences. Dr Windecker reports 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, Aventis, Servier, Sinomed, Terumo, Vifor, and V-Wave. Dr Windecker serves as an unpaid advisory board member and/or unpaid 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, but has not received personal payments by pharmaceutical companies or device manufacturers. He is also 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 has served as a consultant for and received consulting fees and honoraria from Abbott Vascular, Edwards Lifesciences, Cardiovalve, SwissVortex, Perifect, Xeltis, Transseptal Solutions, Magenta, Valtech, and Medtronic; has reported being a cofounder of 4Tech; has received research grant support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received royalties and owns intellectual property rights from Edwards Lifesciences (FMR surgical annuloplasty); and has reported being a shareholder in Cardiovalve, Swiss Vortex, Magenta, Transseptal Solutions, Occlufit, 4Tech, and Perifect. Dr Leon has received institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Hahn has served as a consultant for Abbott Vascular, Abbott Structural, NaviGate, Philips Healthcare, Medtronic, Edwards Lifesciences, and GE Healthcare; has been the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-supported trials, for which she receives no direct industry compensation; has received speaker fees from Boston Scientific and Baylis Medical; and has received nonfinancial support from 3mensio. Dr Latib has served on the advisory board for Medtronic, Abbott Vascular Boston Scientific, Edwards Lifesciences, Shifamed, NeoChord Inc, V-dyne, and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023. Published by Elsevier Inc.)
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- 2023
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31. Sex-related characteristics and short-term outcomes of patients undergoing transcatheter tricuspid valve intervention for tricuspid regurgitation.
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Scotti A, Coisne A, Taramasso M, Granada JF, Ludwig S, Rodés-Cabau J, Lurz P, Hausleiter J, Fam N, Kodali SK, Rosiene J, Feinberg A, Pozzoli A, Alessandrini H, Biasco L, Brochet E, Denti P, Estévez-Loureiro R, Frerker C, Ho EC, Monivas V, Nickenig G, Praz F, Puri R, Sievert H, Tang GHL, Andreas M, Von Bardeleben RS, Rommel KP, Muntané-Carol G, Gavazzoni M, Braun D, Koell B, Kalbacher D, Connelly KA, Juliard JM, Harr C, Pedrazzini G, Russo G, Philippon F, Schofer J, Thiele H, Unterhuber M, Himbert D, Alcázar MU, Wild MG, Windecker S, Jorde U, Maisano F, Leon MB, Hahn RT, and Latib A
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- Male, Humans, Female, Tricuspid Valve surgery, Treatment Outcome, Registries, Tricuspid Valve Insufficiency, Heart Valve Prosthesis Implantation methods, Heart Failure complications
- Abstract
Aims: The impact of sexuality in patients with significant tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI) is unknown. The aim of this study was to investigate sex-specific outcomes in patients with significant TR treated with TTVI vs. medical therapy alone., Methods and Results: The Transcatheter Tricuspid Valve Therapies (TriValve) registry collected data on patients with significant TR from 24 centres who underwent TTVI from 2016 to 2021. A control cohort was formed by medically managed patients with ≥severe isolated TR diagnosed in 2015-18. The primary endpoint was freedom from all-cause mortality. Secondary endpoints were heart failure (HF) hospitalization, New York Heart Association (NYHA) functional status, and TR severity. One-year outcomes were assessed for the TriValve cohort and compared with the control cohort with the inverse probability of treatment weighting (IPTW). A total of 556 and 2072 patients were included from the TriValve and control groups, respectively. After TTVI, there was no difference between women and men in 1-year freedom from all-cause mortality 80.9% vs. 77.9%, P = 0.56, nor in HF hospitalization (P = 0.36), NYHA Functional Classes III and IV (P = 0.17), and TR severity >2+ at last follow-up (P = 0.42). Multivariable Cox-regression weighted by IPTW showed improved 1-year survival after TTVI compared with medical therapy alone in both women (adjusted hazard ratio 0.45, 95% confidence interval 0.23-0.83, P = 0.01) and men (adjusted hazard ratio 0.42, 95% confidence interval 0.18-0.89, P = 0.03)., Conclusion: After TTVI in high-risk patients, there were no sex-related differences in terms of survival, HF hospitalization, functional status, and TR reduction up to 1 year. The IPTW analysis shows a survival benefit of TTVI over medical therapy alone in both women and men., Competing Interests: Conflict of Interest: A.S. has served as a consultant and received consulting fees from NeoChord Inc. A.C. has served as a consultant for Abbott and received speaker fees from Abbott and GE Healthcare. M.T. has served as a consultant for Abbott Vascular, Boston Scientific, 4Tech, and CoreMedic; and has received speaker honoraria from Edwards Lifesciences. S.L. has received travel compensation from Edwards Lifesciences. J.R.C. has received institutional research grants from Edwards Lifesciences. P.L. has received speaker fees from Abbott. J.H. has received speaker honoraria from Abbott Vascular and Edwards Lifesciences. S.K.K. has served on the scientific advisory board for Microinterventional Devices, Dura Biotech, Thubrikar Aortic Valve, and Supira; has served as a consultant for Meril Lifesciences, Admedus, Medtronic, and Boston Scientific; has served on the steering committee for Edwards Lifesciences and Abbott Vascular; has received honoraria from Meril Lifesciences, Admedus, Abbott Vascular, and Dura Biotech; and owns equity in Dura Biotech, Thubrikar Aortic Valve, Supira, and MID. H.A. has received consulting fees from Abbott and Edwards LifeSciences. E.B. has received speaker fees from Abbott Vascular. P.D. has served as a consultant for Abbott Vascular, 4Tech, Neovasc, and InnovHeart; and has received honoraria from Abbott and Edwards Lifesciences. R.E.L. has received speaker fees from Abbott, Boston, and Edwards Lifesciences. E.C.H. has served as a consultant and received consulting fees from NeoChord Inc. F.P. has received travel expenses from Edwards Lifesciences, Abbott Vascular, and Polares Medical. H.S. has received study honoraria, travel expenses, and consulting fees from 4Tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed BV, Contego, CVRx, Edwards Lifesciences, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, PFM Medical, ReCor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, and Vivasure Medical. G.H.L.T. has served as a consultant, physician advisory board member, and faculty trainer for Abbott Structural Heart; has served as a consultant for Medtronic and NeoChord; and has served as a physician advisory board member for JenaValve. M.A. has served as a proctor/consultant for and has received speaking fees from Abbott, Edwards LifeSciences, Boston, Zoll, and Medtronic; and has received institutional grants from Edwards Lifesciences, Abbott, Medtronic, and LSI Solutions. M.G. has served as a consultant for Abbott Vascular. D.B. has received speaker honoraria and travel support from Abbott Vascular. D.K. has received lecture fees from Abbott and Edwards Lifesciences. K.A.C. has received honoraria from Abbott. J.S. has served as a consultant for Edwards Lifesciences. S.W. reports research, travel, or educational grants to the institution from Abbott, Abiomed, Amgen, Astra Zeneca, 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, V-Wave. S.W. serves as unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave, and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers. He is also member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. F.M. has served as a consultant for and received consulting fees and honoraria from Abbott Vascular, Edwards Lifesciences, Cardiovalve, SwissVortex, Perifect, Xeltis, Transseptal Solutions, Magenta, Valtech, and Medtronic; has reported being a cofounder of 4Tech; has received research grant support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received royalties and owns intellectual property rights from Edwards Lifesciences (FMR surgical annuloplasty); and has reported being a shareholder in Cardiovalve, Swiss Vortex, Magenta, Transseptal Solutions, Occlufit, 4Tech, and Perifect. M.B.L. has received institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. R.T.H. has served as a consultant for Abbott Vascular, Abbott Structural, NaviGate, Philips Healthcare, Medtronic, Edwards Lifesciences, and GE Healthcare; has been the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-supported trials, for which she receives no direct industry compensation; has received speaker fees from Boston Scientific and Baylis Medical; and has received nonfinancial support from 3mensio. A.L. has served on the advisory board for Medtronic, Abbott Vascular Boston Scientific, Edwards Lifesciences, Shifamed, NeoChord Inc, V-dyne, and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2023
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32. Right Ventricular-Pulmonary Arterial Coupling and Afterload Reserve in Patients Undergoing Transcatheter Tricuspid Valve Repair.
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Brener MI, Lurz P, Hausleiter J, Rodés-Cabau J, Fam N, Kodali SK, Rommel KP, Muntané-Carol G, Gavazzoni M, Nazif TM, Pozzoli A, Alessandrini H, Latib A, Biasco L, Braun D, Brochet E, Denti P, Lubos E, Ludwig S, Kalbacher D, Estevez-Loureiro R, Connelly KA, Frerker C, Ho EC, Juliard JM, Harr C, Monivas V, Nickenig G, Pedrazzini G, Philippon F, Praz F, Puri R, Schofer J, Sievert H, Tang GHL, Andreas M, Thiele H, Unterhuber M, Himbert D, Alcázar MU, Von Bardeleben RS, Windecker S, Wild MG, Maisano F, Leon MB, Taramasso M, and Hahn RT
- Subjects
- Aged, Echocardiography, Doppler, Female, Follow-Up Studies, Humans, Male, Postoperative Period, Registries, Retrospective Studies, Tricuspid Valve diagnostic imaging, Tricuspid Valve Insufficiency physiopathology, Ventricular Function, Left, Cardiac Surgical Procedures methods, Pulmonary Artery physiopathology, Pulmonary Wedge Pressure physiology, Stroke Volume physiology, Tricuspid Valve surgery, Tricuspid Valve Insufficiency surgery, Ventricular Function, Right physiology
- Abstract
Background: The right ventricular (RV)-pulmonary arterial (PA) coupling ratio relates the efficiency with which RV stroke work is transferred into the PA. Lower ratios indicate an inadequate RV contractile response to increased afterload., Objectives: This study sought to evaluate the prognostic significance of RV-PA coupling in patients with tricuspid regurgitation (TR) who were undergoing transcatheter tricuspid valve repair or replacement (TTVR)., Methods: The study investigators calculated RV-PA coupling ratios for patients enrolled in the global TriValve registry by dividing the tricuspid annular plane systolic excursion (TAPSE) by the PA systolic pressure (PASP) from transthoracic echocardiograms performed before the procedure and 30 days after the procedure. The primary endpoint was all-cause mortality at 1-year follow-up., Results: Among 444 patients analyzed, their mean age was 76.9 ± 9.1 years, and 53.8% of the patients were female. The median TAPSE/PASP ratio was 0.406 mm/mm Hg (interquartile range: 0.308-0.567 mm/mm Hg). Sixty-three patients died within 1 year of TTVR, 21 with a TAPSE/PASP ratio >0.406 and 42 with a TAPSE/PASP ratio ≤0.406. In multivariable Cox regression analysis, a TAPSE/PASP ratio >0.406 vs ≤0.406 was associated with a decreased risk of all-cause mortality (HR: 0.57; 95% CI: 0.35-0.93; P = 0.023). In 234 (52.7%) patients with echocardiograms 30 days after TTVR, a decline in RV-PA coupling was independently associated with reduced odds of all-cause mortality (odds ratio [OR]: 0.42; 95% CI: 0.19-0.93; P = 0.032). The magnitude of TR reduction after TTVR (≥1+ vs <1+; OR: 2.53; 95% CI: 1.06-6.03; P = 0.037) was independently associated with a reduction in post-TTVR RV-PA coupling., Conclusions: RV-PA coupling is a powerful, independent predictor of all-cause mortality in patients with TR undergoing TTVR. These data suggest that the TAPSE/PASP ratio can inform patient selection and prognostication following TTVR., Competing Interests: Funding Support and Author Disclosures Dr Brener has received funding from a National Institute of Health grant (NHLBI-T32HL007343). Dr Lurz has received speaker fees from Abbott. Dr Hausleiter has received speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr Rodés-Cabau has received institutional research grants from Edwards Lifesciences. Dr Kodali has served on the scientific advisory board for Microinterventional Devices, Dura Biotech, Thubrikar Aortic Valve, and Supira; has served as a consultant for Meril Lifesciences, Admedus, Medtronic, and Boston Scientific; has served on the steering committee for Edwards Lifesciences and Abbott Vascular; has received honoraria from Meril Lifesciences, Admedus, Abbott Vascular, and Dura Biotech; and owns equity in Dura Biotech, Thubrikar Aortic Valve, Supira, and MID. Dr Gavazzoni has served as a consultant for Abbott Vascular. Dr Nazif has served as a consultant for and received consulting honoraria from Edwards Lifesciences, Boston Scientific, Medtronic, and Biotrace Medical. Dr Latib has served on the advisory board for Medtronic and Abbott Vascular; has served on the Speakers Bureau for Abbott Vascular; has served on the scientific advisory board for Millipede; and has served as a consultant for 4Tech, Mitralign, and Millipede. Dr Alessandrini has received consulting fees from Abbott and Edwards LifeSciences. Dr Braun has received speaker honoraria and travel support from Abbott Vascular. Dr Brochet has received speaker fees from Abbott Vascular. Dr Lubos has received grant support and lecture fees from Abbott; and has received lecture fees from Edwards Lifesciences. Dr Denti has served as a consultant for Abbott Vascular, 4Tech, Neovasc, and InnovHeart; and has received honoraria from Abbott and Edwards Lifesciences. Dr Ludwig has received travel compensation from Edwards Lifesciences. Dr Kalbacher has received lecture fees from Abbott and Edwards Lifesciences. Dr Estévez-Loureiro has received speaker fees from Abbott, Boston, and Edwards Lifesciences. Dr Connelly has received honoraria from Abbott. Dr Praz has received travel expenses from Edwards Lifesciences, Abbott Vascular, and Polares Medical. Dr Schofer has served as a consultant for Edwards Lifesciences. Dr Sievert has received study honoraria, travel expenses, and consulting fees from 4Tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed BV, Contego, CVRx, Edwards Lifesciences, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, PFM Medical, ReCor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, and Vivasure Medical. Dr Tang has served as a consultant, physician advisory board member, and faculty trainer for Abbott Structural Heart; has served as a consultant for Medtronic and NeoChord; and has served as a physician advisory board member for JenaValve. Dr Andreas has served as a proctor/consultant for and has received speaking fees from Abbott, Edwards LifeSciences, and Medtronic; and has received institutional grants from Edwards Lifesciences, Abbott, Medtronic, and Life Systems International. Dr Windecker has received research and educational grants to the institution from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CardioValve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Johnson & Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed; has served as an unpaid advisory board member and/or unpaid member of the steering or executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers; has reported membership on the steering or executive committee group of several investigator-initiated trials that receive funding by industry without an impact on his personal remuneration; and has been an unpaid member of the Pfizer Research Award selection committee in Switzerland. Dr Maisano has served as a consultant for and received consulting fees and honoraria from Abbott Vascular, Edwards Lifesciences, Cardiovalve, SwissVortex, Perifect, Xeltis, Transseptal Solutions, Magenta, Valtech, and Medtronic; has reported being a cofounder of 4Tech; has received research grant support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received royalties and owns intellectual property rights from Edwards Lifesciences (FMR surgical annuloplasty); and has reported being a shareholder in Cardiovalve, Swiss Vortex, Magenta, Transseptal Solutions, Occlufit, 4Tech, and Perifect. Dr Leon has received institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Taramasso has served as a consultant for Abbott Vascular, Boston Scientific, 4Tech, and CoreMedic; and has received speaker honoraria from Edwards Lifesciences. Dr Hahn has served as a consultant for Abbott Vascular, Abbott Structural, NaviGate, Philips Healthcare, Medtronic, Edwards Lifesciences, and GE Healthcare; has been the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-supported trials, for which she receives no direct industry compensation; has received speaker fees from Boston Scientific and Baylis Medical; and has received nonfinancial support from 3mensio. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2022
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33. Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study.
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Nickenig G, Friedrichs KP, Baldus S, Arnold M, Seidler T, Hakmi S, Linke A, Schäfer U, Dreger H, Reinthaler M, von Bardeleben RS, Möllmann H, Weber M, Roder F, Körber MI, Landendinger M, Wolf F, Alessandrini H, Sveric K, Schewel D, Romero-Dorta E, Kasner M, Dahou A, Hahn RT, and Windecker S
- Subjects
- Cardiac Catheterization, Follow-Up Studies, Humans, Prospective Studies, Quality of Life, Severity of Illness Index, Time Factors, Treatment Outcome, Heart Valve Prosthesis Implantation adverse effects, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery
- Abstract
Background: Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality., Aims: We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study., Methods: Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team., Results: Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p<0.001) of patients achieved ≤moderate TR and 78% had at least one grade TR reduction. At 30 days, all-cause mortality and composite MAE rates were 1.6% and 19.7%, respectively; septolateral annular diameter was reduced by 20%, where 69% of patients achieved ≤moderate TR and 85% of patients had at least one grade TR reduction (all p<0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (p<0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (p<0.001) with improvements in overall KCCQ score by 17 points (p<0.001)., Conclusions: In the TriBAND study, the Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ≥severe functional TR. Results showed significant reductions in annular diameter and TR severity, accompanied by early evidence of right heart remodelling and improvements in functional status and quality of life.
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- 2021
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34. Outcomes of Transcatheter Mitral Valve Repair With Edge-to-Edge Technique in Patients With Barlow Disease.
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Gavazzoni M, Taramasso M, PozzoliZ A, Euscher D, Kuck KH, Bohnen S, Zuber M, Voci D, Maisano F, and Alessandrini H
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- Cardiac Catheterization adverse effects, Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Treatment Outcome, Cardiac Surgical Procedures, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery
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- 2021
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35. Comprehensive echocardiographic prediction of postprocedural transmitral pressure gradient following transcatheter mitral valve repair.
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Alessandrini H, Wohlmuth P, Meincke F, Hakmi S, Ubben T, Bohnen S, Wißt T, Kuck KH, Willems S, and Tigges E
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- Cardiac Catheterization adverse effects, Echocardiography, Female, Humans, Male, Mitral Valve diagnostic imaging, Mitral Valve surgery, Predictive Value of Tests, Retrospective Studies, Treatment Outcome, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency etiology, Mitral Valve Insufficiency surgery
- Abstract
Iatrogenic mitral stenosis following transcatheter mitral valve repair (TMVR) for relevant mitral regurgitation (MR) is a potential adverse side-effect, known to affect long-term outcome. However, only few determinants of an elevated mean transmitral pressure gradient (TMPG) have been described thus far. We sought to develop an integrative model for the prediction of TMPG following MitraClip (MC) therapy. From 01/2013 to 03/2017, a total of 175 consecutive patients were successfully (MR ≤ 2 + at discharge) treated with a MitraClip implantation at our centre. Of these, a total of 148 patients (54% male, 77.0 ± 6.0 years, 58% with secondary MR) had complete echocardiographic data sets comprising pre- and postinterventional two- and three-dimensional transthoracic (TTE) and transoesophageal (TOE) echocardiograms. Comprehensive studies of predefined parameters were performed. An expert-based prediction model including preprocedural variables (annular ellipticity, mitral valve commissure-to-commissure diameter, preprocedural transmitral pressure gradient and MR aetiology) was set up and validated with a total of 200 bootstrap samples. A nomogram was developed to predict the postprocedural TMPG based on selected echocardiographic variables. Introduction of nomogram-based guiding of MC therapy could help identify patients at risk for postprocedural mitral stenosis, have an influence on preprocedural patient selection and intraprocedural decision making., (© 2021. The Author(s), under exclusive licence to Springer Nature B.V.)
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- 2021
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36. Outcomes of transcatheter tricuspid valve intervention by right ventricular function: a multicentre propensity-matched analysis.
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Schlotter F, Miura M, Kresoja KP, Alushi B, Alessandrini H, Attinger-Toller A, Besler C, Biasco L, Braun D, Brochet E, Connelly KA, de Bruijn S, Denti P, Estevez-Loureiro R, Fam N, Gavazzoni M, Himbert D, Ho EC, Juliard JM, Kalbacher D, Kaple R, Kreidel F, Latib A, Lubos E, Ludwig S, Mehr M, Monivas V, Nazif TM, Nickenig G, Pedrazzini G, Pozzoli A, Praz F, Puri R, Rodés-Cabau J, Rommel KP, Schäfer U, Schofer J, Sievert H, Tang GHL, Thiele H, Unterhuber M, Vahanian A, von Bardeleben RS, von Roeder M, Webb JG, Weber M, Wild MG, Windecker S, Zuber M, Hausleiter J, Maisano F, Leon MB, Hahn RT, Lauten A, Taramasso M, and Lurz P
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- Humans, Treatment Outcome, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Ventricular Function, Right, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery, Ventricular Dysfunction, Right diagnostic imaging, Ventricular Dysfunction, Right therapy
- Abstract
Background: Tricuspid regurgitation (TR) has a poor prognosis and limited treatment options and is frequently accompanied by right ventricular (RV) dysfunction. Transcatheter tricuspid valve interventions (TTVI) to reduce TR have been shown to be safe and feasible with encouraging early results. Patient selection for TTVI remains challenging, with the role of right ventricular (RV) function being unknown., Aims: The aims of this study were 1) to investigate survival in a TTVI-treated patient population and a conservatively treated TR population, and 2) to evaluate the outcome of TTVI as compared to conservative treatment stratified according to the degree of RV function., Methods: We studied 684 patients from the multicentre TriValve cohort (TTVI cohort) and compared them to 914 conservatively treated patients from two tertiary care centres. Propensity matching identified 213 pairs of patients with severe TR. As we observed a non-linear relationship of RV function and TTVI outcome, we stratified patients according to tricuspid annular plane systolic excursion (TAPSE) to preserved (TAPSE >17 mm), mid-range (TAPSE 13-17 mm) and reduced (TAPSE <13 mm) RV function. The primary outcome was one-year all-cause mortality., Results: TTVI was associated with a survival benefit in patients with severe TR when compared to matched controls (one-year mortality rate: 13.1% vs 25.8%; p=0.031). Of the three RV subgroups, only in patients with mid-range RV function was TTVI associated with an improved survival (p log-rank 0.004). In these patients, procedural success was associated with a reduced hazard ratio for all-cause mortality (HR 0.22; 95% CI: 0.09, 0.57)., Conclusions: TTVI is associated with reduced mortality compared to conservative therapy and might exert its highest treatment effect in patients with mid-range reduced RV function.
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- 2021
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37. Transcatheter Tricuspid Valve Intervention in Patients With Previous Left Valve Surgery.
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Muntané-Carol G, Taramasso M, Miura M, Gavazzoni M, Pozzoli A, Alessandrini H, Latib A, Attinger-Toller A, Biasco L, Braun D, Brochet E, Connelly KA, Sievert H, Denti P, Lubos E, Ludwig S, Kalbacher D, Estevez-Loureiro R, Fam N, Frerker C, Ho E, Juliard JM, Kaple R, Kodali S, Kreidel F, Harr C, Lauten A, Lurz J, Kresoja KP, Monivas V, Mehr M, Nazif T, Nickening G, Pedrazzini G, Philippon F, Praz F, Puri R, Schäfer U, Schofer J, Tang GHL, Khattab AA, Andreas M, Russo M, Thiele H, Unterhuber M, Himbert D, Urena M, von Bardeleben RS, Webb JG, Weber M, Winkel M, Zuber M, Hausleiter J, Lurz P, Maisano F, Leon MB, Hahn RT, and Rodés-Cabau J
- Subjects
- Aged, Cardiac Catheterization methods, Cardiac Surgical Procedures adverse effects, Female, Follow-Up Studies, Heart Valve Prosthesis Implantation methods, Heart Valve Prosthesis Implantation statistics & numerical data, Humans, Male, Outcome Assessment, Health Care, Patient Readmission statistics & numerical data, Registries statistics & numerical data, Risk Assessment, Risk Factors, Severity of Illness Index, Survival Analysis, Cardiac Catheterization adverse effects, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation adverse effects, Tricuspid Valve surgery, Tricuspid Valve Insufficiency etiology, Tricuspid Valve Insufficiency mortality, Tricuspid Valve Insufficiency surgery, Ventricular Dysfunction, Right diagnosis, Ventricular Dysfunction, Right etiology
- Abstract
Background: Scarce data exist on patients with previous left valve surgery (PLVS) undergoing transcatheter tricuspid valve intervention (TTVI). This study sought to investigate the procedural and early outcomes in patients with PLVS undergoing TTVI., Methods: This was a subanalysis of the multicenter TriValve registry including 462 patients, 82 (18%) with PLVS. Data were analyzed according to the presence of PLVS in the overall cohort and in a propensity score-matched population including 51 and 115 patients with and without PLVS, respectively., Results: Patients with PLVS were younger (72 ± 10 vs 78 ± 9 years; p < 0.01) and more frequently female (67.1% vs 53.2%; P = 0.02). Similar rates of procedural success (PLVS 80.5%; no-PLVS 82.1%; P = 0.73), and 30-day mortality (PLVS 2.4%, no-PLVS 3.4%; P = 0.99) were observed. After matching, there were no significant differences in both all-cause rehospitalisation (PLVS 21.1%, no-PLVS 26.5%; P = 0.60) and all-cause mortality (PLVS 9.8%, no-PLVS 6.7%; P = 0.58). At last follow-up (median 6 [interquartile range 1-12] months after the procedure), most patients (81.8%) in the PLVS group were in NYHA functional class I-II (P = 0.12 vs no-PLVS group), and TR grade was ≤ 2 in 82.6% of patients (P = 0.096 vs no-PVLS group). A poorer right ventricular function and previous heart failure hospitalization determined increased risks of procedural failure and poorer outcomes at follow-up, respectively., Conclusions: In patients with PLVS, TTVI was associated with high rates of procedural success and low early mortality. However, about one-third of patients required rehospitalisation or died at midterm follow-up. These results would support TTVI as a reasonable alternative to redo surgery in patients with PLVS and suggest the importance of earlier treatment to improve clinical outcomes., (Copyright © 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)
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- 2021
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38. Clinical impact of intervention strategies after failed transcatheter mitral valve repair.
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Alessandrini H, Dreher A, Harr C, Wohlmuth P, Meincke F, Hakmi S, Ubben T, Kuck KH, Hassan K, Willems S, Schmoeckel M, and Geidel S
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- Cardiac Catheterization adverse effects, Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Treatment Outcome, Cardiac Surgical Procedures, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery
- Abstract
Aims: Failure of transcatheter mitral valve repair (fTMVR) therapy has a decisive prognostic influence, and complex retreatment is of higher risk. The aim of this analysis was to evaluate the survival outcome following percutaneous procedures and surgery after unsuccessful TMVR interventions for different aetiologies., Methods and Results: Of 824 consecutive patients who had been treated with the MitraClip device at our institution, between September 2009 and May 2019, 63 (7.6%) symptomatic patients with therapy failure and persistent or recurrent mitral regurgitation (MR) underwent reinterventions. An outcome analysis for primary (PMR) and secondary mitral regurgitation (SMR) and subsequent percutaneous versus surgical treatment was carried out. MitraClip reinterventions were performed in 36 patients (57.1%; n=26 SMR, n=10 PMR), while 27 (42.9%; n=13 SMR, n=14 PMR) underwent open heart surgery. Surgical patients with PMR showed lower mortality than patients with SMR (p<0.0001) and ReClip patients with PMR (p=0.073). Atrial fibrillation (HR 2.915, 95% CI: [1.311, 6.480]), prior open heart surgery (2.820 [1.215, 6.544]) and chronic obstructive pulmonary disease (2.506 [1.099, 5.714]) increased the risk of death. The level of post-interventional MR had no relevant impact on survival., Conclusions: We conclude that, after SMR and failed TMVR, reclipping is an appropriate treatment option for symptomatic patients. For PMR patients, surgery must be favoured over a reclipping procedure. However, patients with atrial fibrillation, prior open heart surgery and chronic obstructive pulmonary disease are at risk of reduced survival after reinterventions.
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- 2021
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39. Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study.
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Nickenig G, Weber M, Schüler R, Hausleiter J, Nabauer M, von Bardeleben RS, Sotiriou E, Schäfer U, Deuschl F, Alessandrini H, Kreidel F, Juliard JM, Brochet E, Latib A, Montorfano M, Agricola E, Baldus S, Friedrichs KP, Deo SH, Gilmore SY, Feldman T, Hahn RT, and Maisano F
- Subjects
- Cardiac Catheterization, Humans, Prospective Studies, Retrospective Studies, Severity of Illness Index, Time Factors, Treatment Outcome, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Heart Valve Prosthesis Implantation adverse effects, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery
- Abstract
Aims: Tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report one- and two-year outcomes of the Cardioband tricuspid valve reconstruction system in the treatment of ≥moderate functional TR in the TRI-REPAIR study., Methods and Results: Thirty patients were enrolled in this single-arm, multicentre, prospective study. Patients were evaluated as having ≥moderate, symptomatic functional TR and deemed inoperable due to unacceptable surgical risk. Clinical, functional, and echocardiographic data were prospectively collected up to two years (mean duration 604±227 days). At baseline, 83% were in NYHA Class III-IV, and the mean LVEF was 58%. Technical success was 100%. At two years, there were eight deaths. Echocardiography showed a significant reduction in septolateral annular diameter of 16% (p=0.006) and 72% of patients (p=0.016) with ≤moderate TR grade; 82% of patients were in NYHA Class I-II (p=0.002). Six-minute walk distance and KCCQ score improved by 73 m (p=0.058) and 14 points (p=0.046), respectively., Conclusions: These results demonstrate that the Cardioband tricuspid system showed favourable results in patients with symptomatic, ≥moderate functional TR. Annular reduction and TR severity reduction remained significant and sustained at two years. Patients experienced improvements in quality of life and exercise capacity. ClinicalTrials.gov Identifier: NCT02981953.
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- 2021
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40. Transcatheter Tricuspid Valve Intervention in Patients With Right Ventricular Dysfunction or Pulmonary Hypertension: Insights From the TriValve Registry.
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Muntané-Carol G, Taramasso M, Miura 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, Lubos E, Ludwig S, Kalbacher D, Estevez-Loureiro R, Fam N, Frerker C, Ho E, Juliard JM, Kaple R, Kodali S, Kreidel F, Harr C, Lauten A, Lurz J, Monivas V, Mehr M, Nazif T, Nickening G, Pedrazzini G, Philippon F, Praz F, Puri R, Schäfer U, Schofer J, Sievert H, Tang GHL, Khattab AA, Andreas M, Russo M, Thiele H, Unterhuber M, Himbert D, Urena M, von Bardeleben RS, Webb JG, Weber M, Windecker S, Winkel M, Zuber M, Hausleiter J, Lurz P, Maisano F, Leon MB, Hahn RT, and Rodés-Cabau J
- Subjects
- Aged, Aged, 80 and over, Cardiac Catheterization adverse effects, Female, Humans, Male, New York, Registries, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Heart Valve Prosthesis Implantation, Hypertension, Pulmonary diagnosis, Hypertension, Pulmonary etiology, Hypertension, Pulmonary therapy, Tricuspid Valve Insufficiency complications, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery, Ventricular Dysfunction, Right diagnostic imaging, Ventricular Dysfunction, Right etiology, Ventricular Dysfunction, Right therapy
- Abstract
Background: Scarce data exist on patients with right ventricular dysfunction (RVD) or pulmonary hypertension (PH) undergoing transcatheter tricuspid valve intervention. This study aimed to determine the early and midterm outcomes and the factors associated with mortality in this group of patients., Methods: This subanalysis of the multicenter TriValve (Transcatheter Tricuspid Valve Therapies) registry included 300 patients with severe tricuspid regurgitation with RVD (n=244), PH (n=127), or both (n=71) undergoing transcatheter tricuspid valve intervention. RVD was defined as a tricuspid annular plane systolic excursion <17 mm, and PH as an estimated pulmonary artery systolic pressure ≥50 mm Hg., Results: Mean age of the patients was 77±9 years (54% women). Procedural success was 80.7%, and 9 patients (3%) died during the hospitalization. At a median follow-up of 6 (interquartile range, 2-12) months, 54 patients (18%) died, and the independent associated factors were higher gamma-glutamyl transferase values at baseline (hazard ratio, 1.02 for each increase of 10 u/L [95% CI, 1.002-1.04]), poorer renal function defined as an estimated glomerular filtration rate <45 mL/min (hazard ratio, 2.3 [95% CI, 1.22-4.33]), and the lack of procedural success (hazard ratio, 2.11 [95% CI, 1.17-3.81]). The grade of RVD and the amount of PH at baseline were not found to be predictors of mortality. Most patients alive at follow-up improved their functional class (New York Heart Association I-II in 66% versus 7% at baseline, P <0.001)., Conclusions: In patients with severe tricuspid regurgitation and RVD/PH, transcatheter tricuspid valve intervention was associated with high procedural success and a relatively low in-hospital mortality, along with significant improvements in functional status. However, about 1 out of 5 patients died after a median follow-up of 6 months, with hepatic congestion, renal dysfunction, and the lack of procedural success determining an increased risk. These results may improve the clinical evaluation of transcatheter tricuspid valve intervention candidates and would suggest a closer follow-up in those at increased risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03416166.
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- 2021
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41. Impact of Massive or Torrential Tricuspid Regurgitation in Patients Undergoing Transcatheter Tricuspid Valve Intervention.
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Miura M, Alessandrini H, Alkhodair A, 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, Himbert D, Ho E, Juliard JM, Kaple R, Besler C, Kodali S, Kreidel F, Kuck KH, Latib A, Lauten A, Monivas V, Mehr M, Muntané-Carol G, Nazif T, Nickenig G, Pedrazzini G, Philippon F, Pozzoli A, Praz F, Puri R, Rodés-Cabau J, Schäfer U, Schofer J, Sievert H, Tang GHL, Thiele H, Rommel KP, Vahanian A, Von Bardeleben RS, Webb JG, Weber M, Windecker S, Winkel M, Zuber M, Leon MB, Maisano F, Hahn RT, and Taramasso M
- Subjects
- Aged, Aged, 80 and over, Disease Progression, Europe, Female, Humans, Male, North America, Patient Readmission, Recovery of Function, Registries, Retrospective Studies, Risk Assessment, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, Tricuspid Valve diagnostic imaging, Tricuspid Valve physiopathology, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency mortality, Tricuspid Valve Insufficiency physiopathology, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Cardiac Catheterization mortality, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation mortality, Tricuspid Valve surgery, Tricuspid Valve Insufficiency surgery
- Abstract
Objectives: The aim of this study was to assess the clinical outcome of baseline massive or torrential tricuspid regurgitation (TR) after transcatheter tricuspid valve intervention (TTVI)., Background: The use of TTVI to treat symptomatic severe TR has been increasing rapidly, but little is known regarding the impact of massive or torrential TR beyond severe TR., Methods: The study population comprised 333 patients with significant symptomatic TR from the TriValve Registry who underwent TTVI. Mid-term outcomes after TTVI were assessed according to the presence of massive or torrential TR, defined as vena contracta width ≥14 mm. Procedural success was defined as patient survival after successful device implantation and delivery system retrieval, with residual TR ≤2+. The primary endpoint comprised survival rate and freedom from rehospitalization for heart failure, survival rate, and rehospitalization at 1 year., Results: Baseline massive or torrential TR and severe TR were observed in 154 patients (46.2%) and 179 patients (53.8%), respectively. Patients with massive or torrential TR had a higher prevalence of ascites than those with severe TR (27.3% vs. 20.4%, respectively; p = 0.15) and demonstrated a similar procedural success rate (83.2% vs. 77.3%, respectively; p = 0.21). The incidence of peri-procedural adverse events was low, with no significant between-group differences. Freedom from the composite endpoint was significantly lower in patients with massive or torrential TR than in those with severe TR, which was significantly associated with an increased risk for 1-year death of any cause or rehospitalization for heart failure (adjusted hazard ratio: 1.91; 95% confidence interval: 1.10 to 3.34; p = 0.022). Freedom from the composite endpoint was significantly higher in patients with massive or torrential TR when procedural success was achieved (69.9% vs. 54.2%, p = 0.048)., Conclusions: Baseline massive or torrential TR is associated with an increased risk for all-cause mortality and rehospitalization for heart failure 1 year after TTVI. Procedural success is related to better outcomes, even in the presence of baseline massive or torrential TR. (International Multisite Transcatheter Tricuspid Valve Therapies Registry [TriValve]; NCT03416166)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2020
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42. Value of Echocardiographic Right Ventricular and Pulmonary Pressure Assessment in Predicting Transcatheter Tricuspid Repair Outcome.
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Karam N, Mehr M, Taramasso M, Besler C, Ruf T, Connelly KA, Weber M, Yzeiraj E, Schiavi D, Mangieri A, Vaskelyte L, Alessandrini H, Deuschl F, Brugger N, Ahmad H, Ho E, Biasco L, Orban M, Deseive S, Braun D, Gavazzoni M, Rommel KP, Pozzoli A, Frerker C, Näbauer M, Massberg S, Pedrazzini G, Tang GHL, Windecker S, Schäfer U, Kuck KH, Sievert H, Denti P, Latib A, Schofer J, Nickenig G, Fam N, von Bardeleben RS, Lurz P, Maisano F, and Hausleiter J
- Subjects
- Aged, Aged, 80 and over, Disease Progression, Europe, Female, Heart Failure etiology, Heart Failure physiopathology, Humans, Male, Middle Aged, North America, Predictive Value of Tests, Prospective Studies, Pulmonary Artery physiopathology, Recovery of Function, Registries, Severity of Illness Index, Time Factors, Treatment Outcome, Tricuspid Valve Insufficiency complications, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency physiopathology, Arterial Pressure, Cardiac Catheterization adverse effects, Echocardiography, Pulmonary Artery diagnostic imaging, Tricuspid Valve Insufficiency therapy, Ventricular Function, Right, Ventricular Pressure
- Abstract
Objectives: The aim of this study was to assess the value of echocardiographic right ventricular (RV) and systolic pulmonary artery pressure (sPAP) assessment in predicting transcatheter tricuspid edge-to-edge valve repair (TTVR) outcome., Background: RV dysfunction and pulmonary hypertension are associated with poor prognosis and are systematically sought during tricuspid regurgitation evaluation. The value of echocardiographic assessment in predicting TTVR outcome is unknown., Methods: Data were taken from the TriValve (Transcatheter Tricuspid Valve Therapies) registry, which includes patients undergoing TTVR at 14 European and North American centers. The primary outcome was 1-year survival free from hospitalization for heart failure, and secondary outcomes were 1-year survival and absence of hospital admission for heart failure at 1 year., Results: Overall, 249 patients underwent TTVR between June 2015 and 2018 (mean tricuspid annular plane systolic excursion [TAPSE] 15.8 ± 15.3 mm, mean sPAP 43.6 ± 16.0 mm Hg). Tricuspid regurgitation grade ≥3+ was found in 96.8% of patients at baseline and 29.4% at final follow-up; 95.6% were in New York Heart Association functional class III or IV initially, compared with 34.3% at follow-up (p < 0.05). Final New York Heart Association functional class did not differ among TAPSE and sPAP quartiles, even when both low TAPSE and high sPAP were present. Rates of 1-year survival and survival free from hospitalization for heart failure were 83.9% and 78.7%, respectively, without significant differences according to baseline echocardiographic RV characteristics (TAPSE, fractional area change, and end-diastolic area) and sPAP (p > 0.05 for all)., Conclusions: TTVR provides clinical improvement, with 1-year survival free from hospital readmission >75% in patients with severe tricuspid regurgitation. Conventional echocardiographic parameters used to assess RV function and sPAP did not predict clinical outcome after TTVR., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2020
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43. 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, Rodés-Cabau J, Schäfer 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, and Hahn RT
- Subjects
- Aged, 80 and over, Cardiac Catheterization adverse effects, Cardiac Catheterization mortality, Cardiac Pacing, Artificial adverse effects, Cardiac Pacing, Artificial mortality, Clinical Decision-Making, Electric Countershock adverse effects, Electric Countershock mortality, Europe, Feasibility Studies, Female, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation mortality, Hemodynamics, Hospital Mortality, Humans, Male, Mitral Valve diagnostic imaging, Mitral Valve physiopathology, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency mortality, Mitral Valve Insufficiency physiopathology, North America, Postoperative Complications etiology, Postoperative Complications mortality, Prosthesis Design, Recovery of Function, Registries, Retrospective Studies, Risk Factors, Time Factors, Treatment Outcome, Cardiac Catheterization instrumentation, Defibrillators, Implantable, Electric Countershock instrumentation, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation instrumentation, Mitral Valve surgery, Mitral Valve Insufficiency surgery, Pacemaker, Artificial
- 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 cm
2 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., (Copyright © 2020 American College of Cardiology Foundation. All rights reserved.)- Published
- 2020
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44. Transcatheter Versus Medical Treatment of Patients With Symptomatic Severe Tricuspid Regurgitation.
- Author
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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, Muntané-Carol G, Nazif T, Nickening G, Pedrazzini G, Philippon F, Pozzoli A, Praz F, Puri R, Rodés-Cabau J, Schäfer U, Schofer J, Sievert H, Tang GHL, Thiele H, Topilsky Y, Rommel KP, Delgado V, Vahanian A, Von Bardeleben RS, Webb JG, Weber M, Windecker S, Winkel M, Zuber M, Leon MB, Hahn RT, Bax JJ, Enriquez-Sarano M, and Maisano F
- Subjects
- Aged, Aged, 80 and over, Case-Control Studies, Echocardiography, Europe epidemiology, Female, Humans, Male, North America epidemiology, Tricuspid Valve diagnostic imaging, Tricuspid Valve Insufficiency drug therapy, Tricuspid Valve Insufficiency mortality, Cardiac Surgical Procedures mortality, Endovascular Procedures mortality, Registries, Tricuspid Valve surgery, Tricuspid Valve Insufficiency surgery
- 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., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2019
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45. Leaflet edge-to-edge treatment versus direct annuloplasty in patients with functional mitral regurgitation.
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Weber M, Öztürk C, Taramasso M, Pozzoli A, Pfister R, Wösten M, Alessandrini H, Latib A, Denti P, Kuck KH, Maisano F, Baldus S, and Nickenig G
- Subjects
- Cardiac Catheterization, Humans, Mitral Valve, Treatment Outcome, Heart Valve Prosthesis Implantation, Mitral Valve Annuloplasty, Mitral Valve Insufficiency
- Abstract
Aims: Interventional mitral repair techniques have evolved as safe and effective treatment options for patients with functional mitral regurgitation (FMR) at high or prohibitive surgical risk. Of the techniques available, the MitraClip device and Cardioband mitral repair system have been used most commonly. However, a direct comparison of the two devices, examining their effectiveness at reducing MR, reducing symptoms, and extending life expectancy, has not yet been performed. For this purpose, we compared the outcome of patients after direct annuloplasty by the Cardioband system with patients after edge-to-edge therapy with the MitraClip device in a propensity score-matched analysis., Methods and Results: We collected data concerning 123 consecutive patients who were treated with the Cardioband device and 455 consecutive patients treated with the MitraClip from five experienced European centres. Propensity score matching was performed, resulting in two groups with 93 patients each - with no significant differences regarding baseline demographic parameters - who underwent standardised 2D transthoracic echocardiography with assessment at baseline and clinical follow-up at 12 months. The success rate, defined as a reduction of MR to grade 2 or lower, was high in both groups (MR ≤2: MitraClip: 86%, Cardioband: 77%, p=0.18). The Cardioband was better at reducing heart failure symptoms (NYHA ≤II: 88%) than the MitraClip (75%) procedure (p=0.046) at 12-month follow-up. All-cause rehospitalisation and mortality within 12 months were lower in Cardioband patients (mortality: OR 0.30, CI: 0.09-0.98, p=0.032; rehospitalisation: OR 0.57, CI: 0.28-0.97, p=0.03)., Conclusions: The MitraClip and the Cardioband procedures effectively reduce MR and heart failure symptoms. However, patients undergoing the Cardioband procedure showed a more pronounced improvement with regard to functional NYHA class, rehospitalisation, and mortality, compared to patients undergoing the MitraClip procedure.
- Published
- 2019
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46. Management of arrhythmia recurrence in patients with pulmonary vein stenosis following atrial fibrillation ablation.
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Fink T, Tilz RR, Heeger CH, Schlüter M, Feickert S, Rottner L, Reissmann B, Lemes C, Alessandrini H, Maurer T, Mathew S, Rillig A, Metzner A, Ouyang F, and Kuck KH
- Subjects
- Angiography, Atrial Fibrillation physiopathology, Cryosurgery adverse effects, Electrocardiography, Ambulatory, Female, Follow-Up Studies, Heart Conduction System surgery, Humans, Male, Middle Aged, Recurrence, Retrospective Studies, Stenosis, Pulmonary Vein diagnosis, Stenosis, Pulmonary Vein surgery, Treatment Outcome, Atrial Fibrillation surgery, Catheter Ablation adverse effects, Heart Conduction System physiopathology, Postoperative Complications, Stenosis, Pulmonary Vein etiology, Stents, Vascular Surgical Procedures methods
- Abstract
Aims: Arrhythmia recurrence is a common clinical problem in patients with pulmonary vein stenosis (PVS) following catheter ablation of atrial fibrillation. The study sought to analyse the management of arrhythmia recurrence in patients with PVS., Methods and Results: Retrospective analysis was performed on 29 patients with high-degree PVS. Follow-up contained clinical visits, Holter-electrocardiogram recordings and invasive pulmonary vein (PV) angiography and electrophysiological studies. Arrhythmia recurrence was observed in 18 patients (62%) after PVS formation. Fifteen of 18 patients (83.3%) with and 1 of 11 patients (9.1%) without arrhythmia recurrence had electrical PV reconnection (P = 0.0003). In 14 of 16 patients repeat pulmonary vein isolation (PVI) was conducted (radiofrequency ablation in 12 and cryoballoon ablation in 2 cases). Repeat PVI was successful in all PVs in nine patients and incomplete in five patients (failed attempt in two patients with stent implantation, no attempt in three patients with stenotic PVs). Freedom from arrhythmia recurrence was estimated at 56.3% [95% confidence interval (CI) 36.4-72.0%] after 24 months. At the end of the follow-up, complete PVI was documented in 19 of 23 patients (82.6%) with stable sinus rhythm and in 2 of 6 patients with arrhythmia recurrence (33.3%) (P = 0.0335). The Kaplan-Meier estimate of recurrence-free survival of restenosis after interventional PVS treatment was similar in patients without and with repeat ablation [75.6% (95% CI 57.0-94.3%) and 67.0% (95% CI 43.2-90.7%) after 500 days, P = 0.77]., Conclusions: Pulmonary vein reconnection is the major driver of arrhythmia recurrence in PVS patients. Repeat PVI is feasible and does not lead to progression of PVS or restenosis if the procedure is carefully performed., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2019
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47. 1-Year Outcomes After Edge-to-Edge Valve Repair for Symptomatic Tricuspid Regurgitation: Results From the TriValve Registry.
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Mehr M, Taramasso M, Besler C, Ruf T, Connelly KA, Weber M, Yzeiraj E, Schiavi D, Mangieri A, Vaskelyte L, Alessandrini H, Deuschl F, Brugger N, Ahmad H, Biasco L, Orban M, Deseive S, Braun D, Rommel KP, Pozzoli A, Frerker C, Näbauer M, Massberg S, Pedrazzini G, Tang GHL, Windecker S, Schäfer U, Kuck KH, Sievert H, Denti P, Latib A, Schofer J, Nickenig G, Fam N, von Bardeleben RS, Lurz P, Maisano F, and Hausleiter J
- Subjects
- Aged, Aged, 80 and over, Compassionate Use Trials, Europe, Female, Heart Valve Prosthesis, Hemodynamics, Humans, Male, North America, Recovery of Function, Registries, Retrospective Studies, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, Tricuspid Valve diagnostic imaging, Tricuspid Valve physiopathology, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency mortality, Tricuspid Valve Insufficiency physiopathology, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Cardiac Catheterization mortality, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation mortality, Tricuspid Valve surgery, Tricuspid Valve Insufficiency surgery
- Abstract
Objectives: The purpose of this study was to evaluate procedural and 1-year clinical and echocardiographic outcomes of patients treated with tricuspid edge-to-edge repair., Background: Transcatheter edge-to-edge repair has been successfully performed in selected patients with symptomatic tricuspid regurgitation (TR) and high risk for surgery, but outcome data are sparse., Methods: This analysis of the multicenter international TriValve (Transcatheter Tricuspid Valve Therapies) registry included 249 patients with severe TR treated with edge-to-edge repair in compassionate and/or off-label use. Clinical and echocardiographic outcomes were prospectively collected and retrospectively analyzed., Results: In 249 patients (mean age 77 ± 9 years; European System for Cardiac Operative Risk Evaluation II score 6.4% [interquartile range: 3.9% to 13.9%]), a successful procedure with TR reduction to grade ≤2+ was achieved in 77% by placement of 2 ± 1 tricuspid clips. Concomitant treatment of severe TR and mitral regurgitation was performed in 52% of patients. At 1-year follow-up, significant and durable improvements in TR severity (TR ≤2+ in 72% of patients) and New York Heart Association functional class (≤II in 69% of patients) were observed. All-cause mortality was 20%, and the combined rate of mortality and unplanned hospitalization for heart failure was 35%. Predictors of procedural failure included effective regurgitant orifice area, tricuspid coaptation gap, tricuspid tenting area, and absence of central or anteroseptal TR jet location. Predictors of 1-year mortality were procedural failure, worsening kidney function, and absence of sinus rhythm., Conclusions: Transcatheter tricuspid edge-to-edge repair can achieve TR reduction at 1 year, resulting in significant clinical improvement. Predictors of procedural failure and 1-year mortality identified here may help select patients who will benefit most from this therapy., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2019
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48. Response by Heeger et al to Letter Regarding Article, "Left Atrial Appendage Isolation in Patients Not Responding to Pulmonary Vein Isolation: Benefit and Risks".
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Heeger CH, Rillig A, Geisler D, Wohlmuth P, Fink T, Mathew S, Tilz RR, Reissmann B, Lemes C, Maurer T, Santoro F, Inaba O, Sohns C, Huang Y, Alessandrini H, Dotz I, Schlüter M, Metzner A, Kuck KH, and Ouyang F
- Subjects
- Humans, Atrial Appendage surgery, Atrial Fibrillation surgery, Catheter Ablation, Pulmonary Veins surgery
- Published
- 2019
- Full Text
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49. Predictive impact of previous coronary artery bypass grafting on mortality after MitraClip implantation for ischemic functional mitral regurgitation.
- Author
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Kitamura M, Kaneko H, Schlüter M, Schewel D, Schmidt T, Alessandrini H, Kreidel F, Okamoto M, Neuss M, Butter C, Kuck KH, and Frerker C
- Subjects
- Aged, Female, Follow-Up Studies, Germany epidemiology, Humans, Male, Mitral Valve Insufficiency etiology, Mitral Valve Insufficiency mortality, Myocardial Ischemia mortality, Myocardial Ischemia surgery, Postoperative Period, Prognosis, Prosthesis Design, Retrospective Studies, Survival Rate trends, Coronary Artery Bypass methods, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation methods, Mitral Valve Insufficiency surgery, Myocardial Ischemia complications
- Abstract
Background: Many candidates with ischaemic functional mitral regurgitation (FMR) have previously undergone coronary artery bypass grafting (CABG), in which transcatheter mitral valve repair can be reasonable for ameliorating the deteriorated hemodynamic and heart failure symptoms. We sought to elucidate the outcomes of MitraClip (MC) implantation in patients with symptomatic ischaemic FMR after CABG., Methods: We investigated clinical characteristics, outcomes and predictive impact of previous CABG on mortality in ischaemic FMR patients who underwent MC implantation from two high-volume centres in Germany., Results: We enrolled 159 patients who previously underwent CABG. Compared with a reference group that did not previously undergo CABG (n = 182), the cohort consisted of more elderly patients (75.0, standard deviation [SD] 7.7 versus 72.9, SD 9.6 years, p = 0.028), more men (84% vs. 69%, p < 0.001), and reduced tricuspid annular plane systolic excursion (14.0, SD 4.0, vs. 16.6, SD 4.6 mm, p < 0.0001). The CABG group showed similar outcomes regarding procedural success (91% vs. 94%, p = 0.24) and 30-day mortality (5.0% vs. 6.0%, p = 0.68), but worse survival after MC implantation (log-rank p = 0.019, hazard ratio 1.56 [95% confidence interval (CI) 1.08-2.26]). After propensity score matching (n = 224), the hazard ratio was 1.18 [95%CI 0.76-1.84] without statistical significance (p = 0.46)., Conclusions: Transcatheter mitral valve repair using the MC is a viable treatment option for patients with symptomatic ischaemic FMR after CABG. Although the baseline characteristics seemed to point to sick patients, CABG itself had only a modest impact on survival., (Copyright © 2019 Elsevier B.V. All rights reserved.)
- Published
- 2019
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50. Predictors of mortality in ischaemic versus non-ischaemic functional mitral regurgitation after successful transcatheter mitral valve repair using MitraClip: results from two high-volume centres.
- Author
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Kitamura M, Kaneko H, Schlüter M, Schewel D, Schmidt T, Alessandrini H, Kreidel F, Neuss M, Butter C, Kuck KH, and Frerker C
- Subjects
- Aged, Cause of Death trends, Coronary Angiography, Coronary Vessels diagnostic imaging, Female, Germany epidemiology, Heart Ventricles diagnostic imaging, Heart Ventricles physiopathology, Humans, Incidence, Male, Mitral Valve diagnostic imaging, Mitral Valve Insufficiency etiology, Mitral Valve Insufficiency surgery, Myocardial Ischemia diagnosis, Myocardial Ischemia mortality, Postoperative Complications epidemiology, Prognosis, Prosthesis Design, Retrospective Studies, Survival Rate trends, Systole, Treatment Outcome, Cardiac Catheterization methods, Heart Valve Prosthesis Implantation methods, Hospitals, High-Volume statistics & numerical data, Mitral Valve surgery, Mitral Valve Insufficiency epidemiology, Myocardial Ischemia complications, Ventricular Function, Left physiology
- Abstract
Introduction: Transcatheter edge-to-edge mitral valve repair using the MitraClip has been widely performed in surgical high-risk patients with reduced left ventricular systolic function and severe functional mitral regurgitation (FMR). Ischaemic heart disease is the leading aetiology of heart disease worldwide. We aimed to assess the clinical implications of ischaemic aetiology in patients with severe FMR who underwent MitraClip implantation., Methods and Results: From two high-volume centres in Germany, we retrospectively compared the clinical outcomes and clinical predictors of all-cause mortality after MitraClip implantation in patients with ischaemic (I-FMR) and non-ischaemic FMR (NI-FMR). In the overall FMR cohort (n = 575), there were 336 (58%) patients with I-FMR and 239 (42%) with NI-FMR. There was no significant difference in survival between the two groups (log-rank p = 0.78). In a multivariable Cox regression analysis of all-cause mortality, different predictors were observed for either group. In I-FMR patients, decreasing tricuspid annular systolic excursion [adjusted hazard ratio (HR
adj ) 1.06, 95% confidence interval (95% CI) 1.01-1.14 /1 mm, p = 0.028] and increasing logistic EuroSCORE (HRadj 1.02, 95% CI 1.00-1.03, p = 0.037) were independent predictors, whereas in NI-FMR patients, NT-pro BNP (HRadj 1.05, 95% CI 1.02-1.08, p = 0.001) and age (HRadj 1.06, 95% CI 1.01-1.11, p = 0.013) were independently predictive of mortality., Conclusions: Despite the similar survival between ischaemic and non-ischaemic FMR, different predictors of all-cause mortality were demonstrated. Further clinical studies are mandated to focus on each FMR subgroup with stratification by ischaemic origin.- Published
- 2019
- Full Text
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