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Background: Transcatheter aortic valve replacement (TAVR) has become the standard of care for most patients with severe aortic stenosis (AS), but the impact of medical therapy prescribing patterns on post-TAVR patients has not been thoroughly investigated., Methods: We analyzed Optum claims data from 9,012 adults who received TAVR for AS (January 2014-December 2018). Pharmacy claims data were used to identify patients who filled ACEI/ARB and/or statin prescriptions during the study's 90-day landmark period post-TAVR. Kaplan-Meier and adjusted Cox Proportional Hazards models were used to evaluate the association of prescribing patterns with mortality during the 3-year follow-up period. Subgroup analyses were performed to examine the impact of 11 potential confounders on the observed associations., Results: A significantly lower adjusted 3-year mortality was observed for patients with post-TAVR prescription for ACEI/ARBs (hazard ratio [HR] = 0.82, 95% confidence interval [CI] 0.74-0.91, P = .0003) and statins (HR = 0.85, 95% CI 0.77-0.94, P = .0018) compared to patients who did not fill prescriptions for these medications post-TAVR. Subgroup analyses revealed that the survival benefit associated with ACEI/ARB prescription was not affected by any of the potential confounding variables, except preoperative ACEI/ARB prescription was associated with significantly lower risk of mortality vs postoperative prescription only. No other subgroup variables had significant interactions associated with survival benefits, including preoperative use of statins., Conclusions: In this large-scale, real-world analysis of patients undergoing TAVR, the prescription of ACEI/ARB and statins was associated with a significantly lower risk of mortality at 3-years, especially in those where the medications were initiated preoperatively., Competing Interests: Conflict of interest Dr. Cubeddu reports receiving payments for occasional lectures from Edwards Lifesciences. Ms. Murphy reports current employment at Edwards Lifesciences; and being a stockholder at Edwards Lifesciences. Dr. Asher reports receiving royalties for educational Books from Wolters Kluwer Publishing Company. Dr. Garcia is supported by The Harold C. Schott Foundation Endowed Chair for Structural and Valvular Heart Disease and is proctor and steering committee member for Edwards Lifesciences. Dr. Granada has no disclosures to report. Dr. Don reports current participation on the data safety monitoring board (DSMB) of Statins for rheumatic heart disease-Nepal. Dr. Patel has no disclosures to report. Dr. Albaghdadi has no disclosures to report. Dr. Cavalcante reports receiving consulting fees from Abbott Structural, Aria CV, Boston Scientific, Edwards Lifesciences, Medtronic, Vdyne, W.L. Gore, and Xylocor. Dr. Coylewright reports receiving fees or honoraria for lectures, presentations, speakers bureau, manuscript writing or educational events from Medtronic, Abbott, Occlutech, CardioSmart, Edwards Lifesciences, and Boston Scientific. Dr. Hahn reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation. Dr. Genereux reports receiving consultation fees and institution research grant from Edwards Lifesciences; and receiving payment or honoraria for lectures from Edwards Lifesciences. Dr. Yadav reports receiving consulting fees from Edwards Lifesciences and Abbott Vascular; receiving payment or honoraria for lectures, presentations, speakers bureau, manuscript writing or educational events from Edwards Lifesciences, Abbott Vascular, and Shockwave medical; and current participation on the DSMB or advisory board of Dasi simulations. Dr Thourani reports receiving grants from Edwards Lifesciences; and receiving payment or honoraria for lectures, presentations, speakers bureau, manuscript writing or educational events from Edwards Lifesciences. Dr. Leon reports receiving grants or contracts from Abbott Vascular, Medtronic, Boston Scientific, and Edwards Lifesciences; and receiving consulting fees from Bain Capital., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: We sought to document aortic cusps fluoroscopic projections and their distributions using leaflet alignment which is a novel concept to optimize visualization of leaflets and for guiding BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction) and determine whether these projections were feasible in catheter laboratory., Background: Optimal fluoroscopic projections of aortic valve cusps have not been well described., Methods: A total of 128 pre-transcatheter aortic valve replacement (pre-TAVR) computed tomographies (CT) (72 native valves and 56 bioprosthetic surgical valves) were analyzed. Using CT software (3Mensio, Pie medical imaging, the Netherlands), leaflet alignment was performed and the feasibility of these angles, which were defined as rate of obtainable with efforts (within LAO/RAO of 85° and CRA/CAU of 50°) were evaluated., Results: High feasibility was seen in right coronary cusp (RCC) front view (100%) and left coronary cusp (LCC) side view (99.2%), followed by noncoronary cusp side view (95.3%). In contrast, low feasibility of RCC side view (7.8%) and LCC front view (47.6%) was observed. No statistical differences were seen between the distribution of native valves and bioprosthetic surgical valves. With patient/table tilt of 20°LAO and 10°CRA, the feasibility of RCC side view and LCC front view increased to 43.7 and 85.2%, respectively., Conclusion: Distributions of each cusp's leaflet alignment follows "sigmoid curve" which can provide better understanding of aortic valve cusp orientation in TAVR and BASILICA. RCC side view used in right cusp BASILICA is commonly unachievable in catheter laboratory and may improve with patient/table tilt., (© 2020 Wiley Periodicals LLC.)

Background: Eccentricity of coronary ostial positions in relation to the aortic valve cusp may influence the target laceration location in BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Coronary Artery obstruction). Eccentricity of the coronary ostia in relation to coronary cusps of native and valve-in-valve transcatheter aortic valve replacement (TAVR) was not well described before., Methods: A total of 121 pre-TAVR patients' CT data (72 native valves TAVR and 49 bioprosthetic surgical valves TAVR) was included and coronary ostial eccentricity angles were measured and compared. Coronary ostial angles were measured between mid-cusp line to coronary ostium in CT perpendicular images., Results: In the overall cohort, the right coronary artery (RCA) had an eccentric origin in the majority of cases, favoring the commissure between the right and the non coronary cusp (17.0°, IQR; 10-25). On the other hand, the left coronary artery (LCA) originated most commonly near center of the cusp position (0°, IQR; -8 -7.5) In comparison of native and bioprosthetic valves, RCA ostial angles were more eccentric in native valves (19.0°, IQR; 12-26) than in bioprosthetic valves (14.0°, IQR; 3-20) (p = 0.004). Whereas, LCA ostial angle has no significant differences between native valves (-2.0°, IQR;-7.75-5.75) and bioprosthetic valves (1°, IQR;-8-13), (p = 0.6)., Conclusion: RCA ostia often have an eccentric origin towards the non-coronary cusp, especially in native aortic valves, while LCA ostia commonly originate near the center of the cusp. This finding may contribute to better performance of BASILICA procedures., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr HC Wijeysundera received research funding from Medtronic Inc and Edwards Lifesciences. Dr.JM McCabe is a consultant to Edwards LifeSciences, Boston Scientific. Dr N Piazza is a consultant and proctor for Medtronic and Microport. D Dvir, is a consultant to Edwards Lifesciences, Medtronic, Gore, Jena, Abbott. All other authors have no potential conflicts of interest to disclose with regard to any part of the data or results in this report., (Copyright © 2020 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli., Background: Favorable 30-day outcomes of S3 TAVR in annuli >683 mm 2 have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak., Methods: From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm 2 (range 683.5 to 852.0 mm 2 ) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported., Results: The mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001 for both). Mild paravalvular aortic regurgitation occurred in 21.7% of patients, while moderate or greater paravalvular aortic regurgitation occurred in 4.3%. Mild and moderate or severe transvalvular aortic regurgitation occurred in 11.6% and 0%, respectively. Valve gradients remained stable at 1 year., Conclusions: S3 TAVR in annular areas >683 mm 2 is feasible, with favorable mid-term outcomes., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background Limited data exist on clinical valve thrombosis after transcatheter aortic valve-in-valve (ViV) implantation. Our objective was to determine the incidence, timing, clinical characteristics, and treatment outcomes of patients diagnosed with clinical ViV thrombosis. Methods and Results Centers participating in the Valve-in-Valve International Data Registry were surveyed for thrombosis cases, and clinical valve thrombosis was defined based on a combination of the presence of new valve dysfunction and an imaging evidence of leaflet thrombosis. Three hundred ViV implantations were included. The surgical valve was stented in 86.3% and stentless in 13.7% of cases; and the transcatheter heart valve was self-expanding in 50%, balloon-expandable in 49%, and mechanically expanding in 1.0%. The incidence of clinical valve thrombosis was 7.6% (n=23), diagnosed at a median time of 101 days (interquartile range, 21-226) after the procedure. Fifteen patients (65%) presented with worsening symptoms and 21 (91%) with transvalvular mean gradient elevation. The mean gradient at the time of diagnosis (median 39 mm Hg; interquartile range, 30-44) was significantly higher than immediately post-ViV (13 mm Hg; interquartile range, 8-20.5; P<0.001) and was significantly reduced after oral anticoagulation therapy (17.5 mm Hg; interquartile range, 11-20.5; P<0.001). There were no deaths or strokes related to valve thrombosis. Factors associated with valve thrombosis were oral anticoagulation (odds ratio [95% confidence limits]: 0.067 [0.008-0.543], P=0.011), surgical valve true internal diameter indexed to body surface area (0.537 [0.331-0.873], P=0.012), and Mosaic or Hancock II stented porcine bioprostheses (4.01 [1.287-12.485], P=0.017). Conclusions Clinical valve thrombosis after transcatheter aortic ViV implantation is common, especially in patients not on oral anticoagulation. Although aortic ViV is commonly associated with elevated gradients, valve thrombosis should be ruled out if gradients increase compared with early postprocedural values. A higher incidence was observed after treatment of certain stented porcine surgical valve types, suggesting a specific adjustment of the adjunctive antithrombotic therapy in this subset of ViV patients.

Objectives: The aim of this study was to determine factors affecting paravalvular leak (PVL) in transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli., Background: The largest recommended annular area for the 29-mm S3 is 683 mm 2 . However, experience with S3 TAVR in annuli >683 mm 2 has not been widely reported., Methods: From December 2013 to July 2017, 74 patients across 16 centers with mean area 721 ± 38 mm 2 (range: 684 to 852 mm 2 ) underwent S3 TAVR. The transfemoral approach was used in 95%, and 39% were under conscious sedation. Patient, anatomic, and procedural characteristics were retrospectively analyzed. Valve Academic Research Consortium-2 outcomes were reported., Results: Procedural success was 100%, with 2 deaths, 1 stroke, and 2 major vascular complications at 30 days. Post-dilatation occurred in 32%, with final balloon overfilling (1 to 5 ml extra) in 70% of patients. Implantation depth averaged 22.3 ± 12.4% at the noncoronary cusp and 20.7 ± 9.9% at the left coronary cusp. New left bundle branch block occurred in 17%, and 6.3% required new permanent pacemakers. Thirty-day echocardiography showed mild PVL in 22.3%, 6.9% moderate, and none severe. There was no annular rupture or coronary obstruction. Mild or greater PVL was associated with larger maximum annular and left ventricular outflow tract (LVOT) diameters, larger LVOT area and perimeter, LVOT area greater than annular area, and higher annular eccentricity., Conclusions: TAVR with the 29-mm S3 valve beyond the recommended range by overexpansion is safe, with acceptable PVL and pacemaker rates. Larger LVOTs and more eccentric annuli were associated with more PVL. Longer term follow-up will be needed to determine durability of S3 TAVR in this population., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate overexpanded 29 mm SAPIEN (S3) transcatheter heart valves in patients with aortic annuli area >683 mm 2 ., Background: The largest valve area the 29 mm S3 is specified for is 683 mm 2 . Valve overexpansion has been performed in patients with larger aortic annuli, but data are limited. Moreover, feasibility in areas >740 mm 2 is unknown., Methods: All 29 mm S3 transcatheter aortic valve replacements (TAVR) at a single center over 23-months were retrospectively reviewed. Patients with annulus areas >683 mm 2 were included. Immediate post-TAVR hemodynamics and transthoracic echocardiography (TTE) findings on post-TAVR day-1 and day-30 were recorded., Results: Of 81 29 mm S3 TAVR cases, 3 (3.7%) met inclusion criteria (patients 1, 2, and 3 had CT-scan derived areas of 748.1 mm 2 , 793 mm 2 , and 787 mm 2 , respectively). Annular eccentricity index ranged from 0.12 to 0.25. All underwent transfemoral TAVR with 29 mm S3 valves overexpanded using +4 mL of contrast. Post-dilatation with +5 mL was performed in patient 2. The average valve shortening was 10.68 mm. On day 1, patients 1 and 2 had trace and mild paravalvular leak (PVL) (respectively), whereas, patient 3 had mild-moderate PVL. Patient 1 was also noted to have trace central AR on day 1. No other central AR was noted. Immediate post-procedure aortic regurgitation (AR) index in patients 1, 2, and 3 was 43, 34, and 33 respectively. At 30 days, AR was completely resolved in patient 1, whereas AR severity in patients 2 and 3 remained similar. No patients had > moderate AR at any point during follow-up. No valve migration or embolization occurred. Patient 1 required a permanent pacemaker. No other major complications were noted. All patients were clinically stable at 30 days., Conclusions: TAVR using overexpanded 29 mm S3 in valve areas >740 mm 2 (up to 793 mm 2 ) seemed to be safe and feasible in our small series. Further study in a larger series is needed to determine clinical outcomes in this patient population., (© 2017 Wiley Periodicals, Inc.)

Background: This study describes short-term and mid-term outcomes of nonagenarian patients undergoing transfemoral or transapical transcatheter aortic valve replacement (TAVR) in the Placement of Aortic Transcatheter Valve (PARTNER)-I trial., Methods: From April 2007 to February 2012, 531 nonagenarians, mean age 93 ± 2.1 years, underwent TAVR with a balloon-expandable prosthesis in the PARTNER-I trial: 329 through transfemoral (TF-TAVR) and 202 transapical (TA-TAVR) access. Clinical events were adjudicated and echocardiographic results analyzed in a core laboratory. Quality of life (QoL) data were obtained up to 1 year post-TAVR. Time-varying all-cause mortality was referenced to that of an age-sex-race-matched US population., Results: For TF-TAVR, post-procedure 30-day stroke risk was 3.6%; major adverse events occurred in 35% of patients; 30-day paravalvular leak was greater than moderate in 1.4%; median post-procedure length of stay (LOS) was 5 days. Thirty-day mortality was 4.0% and 3-year mortality 48% (44% for the matched population). By 6 months, most QoL measures had stabilized at a level considerably better than baseline, with Kansas City Cardiomyopathy Questionnaire (KCCQ) 72 ± 21. For TA-TAVR, post-procedure 30-day stroke risk was 2.0%; major adverse events 32%; 30-day paravalvular leak was greater than moderate in 0.61%; and median post-procedure LOS was 8 days. Thirty-day mortality was 12% and 3-year mortality 54% (42% for the matched population); KCCQ was 73 ± 23., Conclusions: A TAVR can be performed in nonagenarians with acceptable short- and mid-term outcomes. Although TF- and TA-TAVR outcomes are not directly comparable, TA-TAVR appears to carry a higher risk of early death without a difference in intermediate-term mortality. Age alone should not preclude referral for TAVR in nonagenarians., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

The inability to reposition or retrieve balloon-expandable transcatheter aortic valves once they have been deployed requires implantation of the valve in the descending aorta or open surgical procedures to extract the valve. We describe the challenging transfemoral delivery of an Edwards Lifesciences Sapien valve wherein we had difficulty crossing the aortic valve and the guidewire position was compromised. We performed a transapical puncture to snare the guidewire and create a left ventricular to femoral wire rail, allowing us to deliver the transfemoral transcatheter valve, salvaging a situation where we would have been required to implant the valve in the descending aorta. We believe this is the first time this technique has been reported and represents an important method to facilitate delivery of transcatheter valves where guidewire support is insufficient or lost.