1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses.

This study evaluated the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF). Self-expanding TAVR is superior to medical therapy for patients with severe native aortic valve stenosis at increased surgical risk. The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation. SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p < 0.001). Self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality and major stroke rate, significantly improved aortic valve hemodynamics, and low rates of moderate and no severe residual aortic regurgitation, with improved quality of life.

Deeb GM ，Chetcuti SJ ，Reardon MJ ，Patel HJ ，Grossman PM ，Schreiber T ，Forrest JK ，Bajwa TK ，O'Hair DP ，Petrossian G ，Robinson N ，Katz S ，Hartman A ，Dauerman HL ，Schmoker J ，Khabbaz K ，Watson DR ，Yakubov SJ ，Oh JK ，Li S ，Kleiman NS ，Adams DH ，Popma JJ ... -  《-》

Self-Expanding Transcatheter Aortic Valve Replacement Versus Surgical Valve Replacement in Patients at High Risk for Surgery: A Study of Echocardiographic Change and Risk Prediction.

The CoreValve US High-Risk Clinical Study compared clinical outcomes and serial echocardiographic findings in patients with severe aortic valve stenosis after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis or surgical aortic valve replacement (SAVR). Eligible patients were randomly assigned 1:1 to TAVR with a self-expanding bioprosthesis or SAVR (N=747). Echocardiograms were obtained at baseline, discharge, 30 days, 6 months, and 1 year after the procedure and were analyzed at a central core laboratory. Compared with SAVR patients (N=357), TAVR patients (N=390) had a lower mean aortic valve gradient, larger valve area, and less patient-prosthesis mismatch (all P<0.001), but more paravalvular regurgitation at discharge, which decreased at 1 year. SAVR patients experienced significant right ventricular systolic dysfunction at discharge and 1 month with normal right ventricular function at 1 year. One-year all-cause mortality was 14.2% for TAVR and 19.1% for SAVR patients. Preimplantation aortic regurgitation ≥mild was associated with reduced mortality hazard for both the TAVR (hazard ratio 0.48, 95% confidence interval 0.27-0.85; P=0.01) and the SAVR groups (hazard ratio 0.53, 95% confidence interval 0.32-0.87; P=0.01). Aortic regurgitation ≥mild after TAVR was associated with increased risk for all-cause mortality (hazard ratio 1.95, 95% confidence interval 1.08-3.53; P=0.03). In patients with severe aortic stenosis at increased surgical risk, TAVR was associated with better systolic valve performance, similar left ventricular remodeling, more paravalvular regurgitation, and less right ventricular systolic dysfunction compared with SAVR. Despite an overall mortality reduction for the TAVR group, ≥mild aortic valve regurgitation after TAVR was associated with an increased mortality hazard. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01240902.

Little SH ，Oh JK ，Gillam L ，Sengupta PP ，Orsinelli DA ，Cavalcante JL ，Chang JD ，Adams DH ，Zorn GL 3rd ，Pollak AW ，Abdelmoneim SS ，Reardon MJ ，Qiao H ，Popma JJ ... -  《-》

Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses.

Dauerman HL ，Deeb GM ，O'Hair DP ，Waksman R ，Yakubov SJ ，Kleiman NS ，Chetcuti SJ ，Hermiller JB Jr ，Bajwa T ，Khabbaz K ，de Marchena E ，Salerno T ，Dries-Devlin JL ，Li S ，Popma JJ ，Reardon MJ ... -  《-》

Long-Term Outcomes After Transcatheter Aortic Valve-in-Valve Replacement.

de Freitas Campos Guimarães L ，Urena M ，Wijeysundera HC ，Munoz-Garcia A ，Serra V ，Benitez LM ，Auffret V ，Cheema AN ，Amat-Santos IJ ，Fisher Q ，Himbert D ，Garcia Del Blanco B ，Dager A ，Le Breton H ，Paradis JM ，Dumont E ，Pibarot P ，Rodés-Cabau J ... -  《-》

Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial.

Pibarot P ，Salaun E ，Dahou A ，Avenatti E ，Guzzetti E ，Annabi MS ，Toubal O ，Bernier M ，Beaudoin J ，Ong G ，Ternacle J ，Krapf L ，Thourani VH ，Makkar R ，Kodali SK ，Russo M ，Kapadia SR ，Malaisrie SC ，Cohen DJ ，Leipsic J ，Blanke P ，Williams MR ，McCabe JM ，Brown DL ，Babaliaros V ，Goldman S ，Szeto WY ，Généreux P ，Pershad A ，Alu MC ，Xu K ，Rogers E ，Webb JG ，Smith CR ，Mack MJ ，Leon MB ，Hahn RT ，PARTNER 3 Investigators ... -  《-》