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 ... -  《-》

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 ... -  《-》

Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement: The All-Comers Nordic Aortic Valve Intervention Randomized Clinical Trial.

The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize all-comers with severe native aortic valve stenosis to either transcatheter aortic valve replacement (TAVR) with the CoreValve self-expanding bioprosthesis or surgical aortic valve replacement (SAVR), including a lower-risk patient population than previous trials. This article reports 2-year clinical and echocardiographic outcomes from the NOTION trial. Two-hundred eighty patients from 3 centers in Denmark and Sweden were randomized to either TAVR (n=145) or SAVR (n=135) with follow-up planned for 5 years. There was no difference in all-cause mortality at 2 years between TAVR and SAVR (8.0% versus 9.8%, respectively; P=0.54) or cardiovascular mortality (6.5% versus 9.1%; P=0.40). The composite outcome of all-cause mortality, stroke, or myocardial infarction was also similar (15.8% versus 18.8%, P=0.43). Forward-flow hemodynamics were improved following both procedures, with effective orifice area significantly more improved after TAVR than SAVR (effective orifice area, 1.7 versus 1.4 cm(2) at 3 months). Mean valve gradients were similar after TAVR and SAVR. When patients were categorized according to Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) (<4% versus ≥4%), there was no statistically significant difference for TAVR and SAVR groups in the composite outcome for low-risk (14.7%, 95% confidence interval, 8.3-21.2 versus 16.8%; 95% confidence interval, 9.7-23.8; P=0.58) or intermediate-risk patients (21.1% versus 27.1%; P=0.59). Two-year results from the NOTION trial demonstrate the continuing safety and effectiveness of TAVR in lower-risk patients. Longer-term data are needed to verify the durability of this procedure in this patient population. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01057173.

Søndergaard L ，Steinbrüchel DA ，Ihlemann N ，Nissen H ，Kjeldsen BJ ，Petursson P ，Ngo AT ，Olsen NT ，Chang Y ，Franzen OW ，Engstrøm T ，Clemmensen P ，Olsen PS ，Thyregod HG ... -  《-》

Prosthesis-patient mismatch in high-risk patients with severe aortic stenosis: A randomized trial of a self-expanding prosthesis.

We compared the incidence of prosthesis-patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence of PPM on clinical outcomes. Patients with severe aortic stenosis and at increased risk for surgery were randomized 1:1 to TAVR or SAVR. Postoperative PPM was defined by the effective orifice area index (EOAi) as severe PPM (EOAi ≤ 0.65 cm(2)/m(2)) and no severe PPM (EOAi > 0.65 cm(2)/m(2)); clinical outcomes were analyzed in the TAVR arm (n = 389) and SAVR arm (n = 353). Left ventricular mass index and regression were analyzed at baseline and 1 year. The incidence of severe PPM in the SAVR group at 1 year was 25.7% versus 6.2% in the TAVR group (P < .0001). Left ventricular mass index regression at 1 year was 6.8% for TAVR and 15.1% for SAVR in patients with severe PPM. At 1 year the rate of all-cause mortality and acute kidney injury were significantly greater in all patients (TAVR + SAVR) with severe PPM compared with no severe PPM (20.6% vs 12.0% [P = .0145] for death and 19.2% vs 8.5% [P = .0008] for acute kidney injury). In patients with high surgical risk and severe aortic stenosis, severe PPM is more common in patients treated with SAVR than those treated with TAVR. Patients with severe PPM are a greater risk for death and acute kidney injury than patients without severe PPM.

Zorn GL 3rd ，Little SH ，Tadros P ，Deeb GM ，Gleason TG ，Heiser J ，Kleiman NS ，Oh JK ，Popma JJ ，Adams D ，Huang J ，Reardon MJ ... -  《-》

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 ... -  《-》