3-Year Outcomes From the Evolut Low Risk TAVR Bicuspid Study.

Outcomes from transcatheter aortic valve replacement (TAVR) in low-surgical risk patients with bicuspid aortic stenosis beyond 2 years are limited. This study aimed to evaluate 3-year clinical and echocardiographic outcomes from the Evolut Low Risk Bicuspid Study. The Evolut Low Risk Bicuspid Study is a prospective, multicenter, single-arm study conducted in 25 U.S. Patients with severe aortic stenosis at low surgical risk with bicuspid aortic valve anatomy (all subtypes) underwent TAVR with a self-expanding, supra-annular Evolut R or PRO (Medtronic) bioprosthesis. An independent clinical events committee adjudicated all deaths and endpoint-related adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints. An attempted implant was performed in 150 patients from December 2018 to October 2019. The mean age was 70.3 ± 5.5 years, 48% (72/150) of the patients were women, and the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.3% (Q1-Q3: 0.9%-1.7%). Sievers type 1 was the dominant bicuspid morphology (90.7%, 136/150). The Kaplan-Meier rates of all-cause mortality or disabling stroke were 1.3% (95% CI: 0.3%-5.3%) at 1 year, 3.4% (95% CI: 1.4%-8.1%) at 2 years, and 4.1% (95% CI: 1.6%-10.7%) at 3 years. The incidence of new permanent pacemaker implantation was 19.4% (95% CI: 12.4%-29.6%) at 3 years. There were no instances of moderate or severe paravalvular aortic regurgitation at 2 and 3 years after TAVR. The 3-year results from the Evolut Low Risk Bicuspid Study demonstrate low rates of all-cause mortality or disabling stroke and favorable hemodynamic performance.

Zahr F ，Ramlawi B ，Reardon MJ ，Deeb GM ，Yakubov SJ ，Song HK ，Kleiman NS ，Chetcuti SJ ，Gada H ，Mumtaz M ，Leung S ，Merhi W ，Rovin JD ，DeFrain M ，Muppala M ，Kauten J ，Rajagopal V ，Huang J ，Ito S ，Forrest JK ... -  《-》

Valve Performance Between Latest-Generation Balloon-Expandable and Self-Expandable Transcatheter Heart Valves in a Small Aortic Annulus.

Transcatheter aortic valve replacement (TAVR) using a self-expandable valve (SEV) promotes better hemodynamics compared with a balloon-expandable valve (BEV) in a small aortic annulus (SAA). The authors sought to compare hemodynamic properties and clinical outcomes between the latest-generation BEV and SEV after TAVR for SAA. We retrospectively analyzed 1,227 patients undergoing TAVR for aortic stenosis with SAA, defined as an annulus area ≤430 mm2, using the BEV (SAPIEN3 Ultra RESILIA, Edwards Lifesciences) and SEV (Evolut FX, Medtronic). The impact of valve design on severe prosthesis-patient mismatch, aortic valve mean pressure gradient ≥20 mm Hg, paravalvular leakage (PVL) ≥ mild, new permanent pacemaker implantation (PMI), and modified VARC-3 device success at discharge was evaluated using logistic regression and propensity score analysis. Of 1,227 patients, 798 (65.0%) underwent TAVR with BEV implantation. TAVR using BEV had a relatively higher rate of severe prosthesis-patient mismatch (OR: 1.74; 95% CI: 0.54-5.62) and significantly higher incidence of mean pressure gradient ≥20 mm Hg (OR: 2.05; 95% CI: 0.91-4.62) than that using SEV. By contrast, the BEV showed significantly lower incidence of PVL ≥ mild (OR: 0.19; 95% CI: 0.14-0.26), and new PMI (OR: 0.53; 95% CI: 0.33-0.86). The rate of device success was comparable between the BEV and the SEV. These results were confirmed by propensity score analysis. In TAVR for SAA, SEV demonstrated better hemodynamics than the latest BEV, whereas the latest BEV had lower incidences of PVL ≥ mild and new PMI than the SEV.

Hioki H ，Yamamoto M ，Shirai S ，Ohno Y ，Yashima F ，Naganuma T ，Yamawaki M ，Watanabe Y ，Yamanaka F ，Mizutani K ，Ryuzaki T ，Noguchi M ，Izumo M ，Takagi K ，Asami M ，Ueno H ，Nishina H ，Otsuka T ，Suzuyama H ，Yamasaki K ，Nishioka K ，Hachinohe D ，Fuku Y ，Hayashida K ，OCEAN-TAVI Investigators ... -  《-》

Effects of Bioprosthetic Valve Fracturing on Valve-in-Valve Transcatheter Aortic Valve Implantation Transvalvular Gradients.

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is quickly becoming a routine and effective means by which to treat degenerated bioprosthetic valves. A known complication of ViV-TAVI is patient-prosthesis mismatch, which substantially affects survival. Bioprosthetic valve fracture is a method by which to reduce the risk of patient-prosthesis mismatch and post-ViV-TAVI transvalvular gradients. This study sought to determine the safety and efficacy of post-ViV-TAVI bioprosthetic valve fracture. Patients with a history of surgical aortic valve replacement undergoing ViV-TAVI bioprosthetic valve fracture (N = 25) at the corresponding institution from 2015 to 2022 were cataloged for a retrospective analysis. The implanted transcatheter valves were Medtronic Evolut R, Evolut PRO, and Evolut PRO+. Gradients were assessed before and after implantation and after fracturing using transthoracic echocardiogram. The mean left ventricular ejection fraction of patients who underwent fracturing was 55.04%. The average (SD) peak and mean (SD) transvalvular gradients before the intervention were 68.17 (19.09) mm Hg and 38.98 (14.37) mm Hg, respectively. After ViV-TAVI, the same gradients were reduced to 27.25 (12.27) mm Hg and 15.63 (6.47) mm Hg, respectively. After bioprosthetic valve fracture, the gradients further decreased to 17.59 (7.93) mm Hg and 8.860 (3.334) mm Hg, respectively. The average reduction in peak gradient associated with fracturing was 12.07 mm Hg (95% CI, 5.73-18.41 mm Hg; P = .001). The average reduction in mean gradient associated with valve fracturing was 6.97 mm Hg (95% CI, 3.99-9.74 mm Hg; P < .001). Bioprosthetic valve fracture is a viable option for reducing residual transvalvular gradients after ViV-TAVI and should be considered in patients with elevated gradients (>20 mm Hg) or with concern for patient-prosthesis mismatch in patients who have an unacceptable risk for a redo sternotomy and surgical aortic valve replacement.

Hallak O ，Fischer K ，Ailawadi S ，Valencia D ，Yatsynovich Y ，Nazir R ，Schwartz B ... -  《-》

Impact of moderate or severe mitral and tricuspid valves regurgitation after transcatheter aortic valve replacement.

Tricuspid regurgitation (TR) and mitral regurgitation (MR) are common valvular conditions encountered in patients undergoing transcatheter aortic valve replacement (TAVR). This retrospective study investigates the impact of moderate or severe TR and MR on all-cause mortality in 1-year post-TAVR patients. Consecutive patients who underwent TAVR at the 3 academic tertiary care centers in our health system between 2012 and 2018 were identified. Patients were stratified into 2 groups based on valvular regurgitation severity: moderate/severe MR vs no/mild MR, and moderate/severe TR vs no/mild TR. Primary outcome was all-cause mortality at 1-year and 5-year follow up, and secondary outcome was in-hospital death. Logistic regression analysis was conducted to assess the relationship between moderate/severe MR or TR and all-cause mortality at 1-year and 5-year follow-up. We included a total of 1,071 patients who underwent TAVR with mean age 80.9 ± 8.6 years, 97% white, and 58.3% males. Moderate or severe MR group included 52 (4.88%) patients while mild or no MR group included 1,015 (95.12%) patients. There was no significant difference between both groups in TAVR procedure success rate (100% vs 97.83%, P = .283), in-hospital mortality (0 vs 1.08%, P = .450), or mortality at 1-year follow up (15.38% vs 14.09%, P = .794). At 5-year follow up, moderate/severe MR group had higher mortality (61.4% vs 49.5%, P = .046). In multivariable logistic regression analysis, moderate or severe MR did not show significant correlation with all-cause mortality at 1-year and 5-year follow up. Moderate or severe TR group included 86 (8.03%) patients while mild or no TR group included 985 (91.97%) patients. There was no difference between both groups in TAVR procedure success (98.8% vs 97.9%, P = .54) or in-hospital mortality (0% vs 1.1%, P = .33). At 1-year follow up, patients with moderate or severe TR had higher mortality (26.7% vs 13.2%, P = .001) compared to patients with mild or no TR. Same finding was noted with extended follow up at 5-years (68.3% vs 48.7%, P < .001). In multivariable cox regression analysis, moderate/severe TR was associated with higher all-cause mortality at 1-year (OR 1.94, 95% CI [01.09, 3.44], P = .023) and at 5-year (OR 1.46, 95% CI [1.092, 1.952], P = .011) follow up. Patients with combined moderate/severe MR and TR have even higher mortality compared to either moderate/severe valve regurgitation alone or mild/no valve regurgitation at 5-year follow up. At long term follow up, moderate/severe TR, but not MR, is associated with higher mortality in patients underwent TAVR. Combined moderate/severe TR and MR had even worse mortality. Careful assessment of multivalvular heart disease prior to the procedure is warranted.

Abraham B ，Suppah M ，Farina J ，Botros M ，Fath A ，Kaldas S ，Megaly M ，Chao CJ ，Arsanjani R ，Ayoub C ，Fortuin FD ，Sweeney J ，Pellikka P ，Nkomo V ，Alkhouli M ，Holmes D Jr ，Badr A ，Alsidawi S ... -  《-》

Impact of Measured and Predicted Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement.

Prosthesis-patient mismatch after transcatheter aortic valve replacement (TAVR) can be measured echocardiographically (measured prosthesis-patient mismatch [PPMm]) or predicted (predicted prosthesis-patient mismatch [PPMp]) using published effective orifice area (EOA) reference values. However, the clinical implications of PPM post-TAVR remain unclear. This study aimed to elucidate the prevalence of PPMm and PPMp post-TAVR and their impact on mortality in a large international cohort. The IMPPACT TAVR (Impact of Measured or Predicted Prosthesis-pAtient mismatCh after TAVR) registry included 38,808 TAVR patients from 26 international centers. Valve Academic Research Consortium 3 criteria were used to define prosthesis-patient mismatch severity. EOA was determined echocardiographically (PPMm) or predicted (PPMp) based on core lab-derived EOA reference values. The primary endpoint was 2-year all-cause mortality. The prevalence of PPMp (moderate: 6.8%, severe: 0.6%) was significantly lower than that of PPMm (moderate: 20.7%, severe: 4.3%; P < 0.001) with negligible correlation between the 2 methods (Kendall's tau c correlation coefficient: 0.063; P < 0.001). In unadjusted analyses, severe PPMm adversely influenced 2-year survival (HR: 1.22; 95% CI: 1.02-1.45; P = 0.027), whereas severe PPMp was not associated with outcomes (HR: 0.81; 95% CI: 0.55-1.19; P = 0.291). After adjusting for confounders, neither PPMm nor PPMp had a significant effect on 2-year all-cause mortality. PPMm and PPMp were associated with different patient characteristics, with PPMm tending toward worse (especially low flow) and PPMp toward better (especially women) survival. After adjusting for confounders, neither PPMm nor PPMp significantly affected 2-year all-cause mortality. Hence, valve selection should not solely be based on hemodynamics but rather on a holistic approach, including patient and procedural specifics.

Guthoff H ，Abdel-Wahab M ，Kim WK ，Witberg G ，Wienemann H ，Thurow M ，Shamekhi J ，Eckel C ，von der Heide I ，Veulemans V ，Landt M ，Barbanti M ，Finkelstein A ，Schewel J ，Van Mieghem N ，Adrichem R ，Toggweiler S ，Rheude T ，Nombela-Franco L ，Amat-Santos IJ ，Ruile P ，Estévez-Loureiro R ，Bunc M ，Branca L ，De Backer O ，Tarantini G ，Mylotte D ，Arzamendi D ，Pauly M ，Bleiziffer S ，Renker M ，Al-Kassou B ，Möllmann H ，Ludwig S ，Zeus T ，Tamburino C ，Schmidt T ，Rück A ，von Stein P ，Thiele H ，Abdelhafez A ，Adam M ，Baldus S ，Rudolph T ，Mauri V ，IMPPACT TAVR Investigators ... -  《-》