Transapical aortic valve replacement for severe aortic stenosis: results from the nonrandomized continued access cohort of the PARTNER trial.

Transapical (TA) aortic valve replacement was an integral part of the Placement of Transcatheter Aortic Valves (PARTNER) trial. Enrollment during the randomized trial included 104 transapical (premarket approval TA [PMA-TA]) and 92 surgical aortic valve replacements (SAVR) within the TA cohort. On completion of the trial, enrollment continued in a nonrandomized continued access (NRCA) program. We compared the outcomes of NRCA-TA procedures with those of PMA-TA and SAVR. In 22 centers, 975 patients underwent TA aortic valve replacement as part of the NRCA registry. Inclusion and exclusion criteria were unchanged from the previously reported PARTNER trial. All patients were followed up for at least 1 year. Thirty-day or in-hospital mortality was 8.8% for the NRCA-TA cohort, compared with 10.6% and 12.0% for the PMA-TA and SAVR patients, respectively (p = 0.54). One-year mortality in the NRCA-TA cohort was 22.1%, not significantly lower than the mortality in PMA-TA and SAVR patients at 29.0% and 25.3%, respectively (p = 0.27). Thirty-day or in-hospital stroke was 2.2% among NRCA-TA patients in contrast to the 6.7% stroke rate observed in the PMA-TA group and 5.4% in SAVR patients (p = 0.008). Lower rates of neurologic adverse events in the NRCA-TA group persisted at 1 year compared with the PMA-TA and SAVR patients. Among the 975 patients in the NRCA-TA cohort, rates of major outcomes including death and stroke compared favorably with outcomes of PMA-TA and SAVR patients enrolled in the PARTNER trial. This trend toward improved outcomes may be attributed to improved patient selection, individual centers surmounting the procedural learning curve, and refinements in surgical technique.

Dewey TM ，Bowers B ，Thourani VH ，Babaliaros V ，Smith CR ，Leon MB ，Svensson LG ，Tuzcu EM ，Miller DC ，Teirstein PS ，Tyner J ，Brown DL ，Fontana GP ，Makkar RR ，Williams MR ，George I ，Kirtane AJ ，Bavaria JE ，Mack MJ ... -  《-》

Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: Insights from the PARTNER Trial (Placement of Aortic Transcatheter Valve).

This study sought to examine sex-specific differences in outcomes after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) in high-risk patients with severe aortic stenosis. The PARTNER (Placement of Aortic Transcatheter Valve) trial demonstrated similar 2-year survival with SAVR or TAVR for high-risk patients, but sex-specific outcomes are unknown. In all, 699 patients (300 female) were randomly assigned 1:1 to either SAVR or TAVR with a balloon expandable pericardial tissue valve. Baseline characteristics and 2-year outcomes of TAVR versus SAVR were compared among males and females. Baseline characteristics differed between the sexes. Despite higher Society of Thoracic Surgeons mortality risk scores (11.9 vs. 11.6; p = 0.05), female patients had lower prevalence of coronary artery disease (64.4% vs. 83.7%), prior coronary artery bypass graft surgery (19.8% vs. 61.2%), peripheral vascular disease (36.4% vs. 46.9%), diabetes mellitus (35.6% vs. 45.6%), and elevated creatinine (11.7% vs. 23.9%). Among female patients, procedural mortality trended lower with TAVR versus SAVR (6.8% vs. 13.1%; p = 0.07) and was maintained throughout follow-up (hazard ratio [HR]: 0.67; 95% confidence interval [CI]: 0.44 to 1.00; p = 0.049), driven by the transfemoral arm (HR: 0.55; 95% CI: 0.32 to 0.93; p = 0.02). Among male patients, although procedural mortality was lower with TAVR (6% vs. 12.1%; p = 0.03), there was no overall survival benefit (HR: 1.15; 95% CI: 0.82 to 1.61; p = 0.42). In this retrospective subanalysis of high-risk, symptomatic aortic stenosis patients in the PARTNER trial, female subjects had lower late mortality with TAVR versus SAVR. This was especially true among patients suitable for transfemoral access and suggests that TAVR may be preferred over surgery for high-risk female patients. A randomized, controlled trial conducted specifically in female patients is necessary to properly study differences in mortality between treatment modalities. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

Williams M ，Kodali SK ，Hahn RT ，Humphries KH ，Nkomo VT ，Cohen DJ ，Douglas PS ，Mack M ，McAndrew TC ，Svensson L ，Thourani VH ，Tuzcu EM ，Weissman NJ ，Kirtane AJ ，Leon MB ... -  《-》

Outcomes of patients with chronic lung disease and severe aortic stenosis treated with transcatheter versus surgical aortic valve replacement or standard therapy: insights from the PARTNER trial (placement of AoRTic TraNscathetER Valve).

The study aimed to evaluate the impact of chronic lung disease (CLD) on outcomes of severe aortic stenosis patients across all treatment modalities. Outcomes of patients with CLD undergoing transcatheter aortic valve replacement (TAVR) have not been systematically examined. All patients who underwent TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve) trial, including the continued access registry (n = 2,553; 1,108 with CLD), were evaluated according to CLD clinical severity. Additionally, outcomes of CLD patients included in the randomization arms of the PARTNER trial were compared: Cohort A patients (high-risk operable) treated by either TAVR (n = 149) or surgical aortic valve replacement (SAVR); (n = 138); and Cohort B patients (inoperable) treated by either TAVR (n = 72) or standard therapy only (n = 95). Among all TAVR-treated patients, at 1-year follow-up, patients with CLD had higher mortality than those without it (23.4% vs. 19.6%, p = 0.02). Baseline characteristics of CLD patients who underwent TAVR were similar to respective controls. In Cohort A, 2-year all-cause death rates were similar (TAVR 35.2% and SAVR 33.6%, p = 0.92), whereas in Cohort B, the death rate was lower after TAVR (52.0% vs. 69.6% after standard therapy only, p = 0.04). Independent predictors for mortality in CLD patients undergoing TAVR included poor mobility (6-min walk test <50 m; hazard ratio: 1.67, p = 0.0009) and oxygen-dependency (hazard ratio: 1.44, p = 0.02). Although CLD patients undergoing TAVR have worse outcomes than patients without CLD, TAVR is better in these patients than standard therapy and is similar to SAVR. Although patients with CLD undergoing TAVR had worse outcomes than patients without CLD, TAVR performed better in these patients than standard therapy and was similar to SAVR. However, CLD patients who were either poorly mobile or oxygen-dependent had poor outcomes. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

Dvir D ，Waksman R ，Barbash IM ，Kodali SK ，Svensson LG ，Tuzcu EM ，Xu K ，Minha S ，Alu MC ，Szeto WY ，Thourani VH ，Makkar R ，Kapadia S ，Satler LF ，Webb JG ，Leon MB ，Pichard AD ... -  《-》

Outcomes after transfemoral transcatheter aortic valve replacement: a comparison of the randomized PARTNER (Placement of AoRTic TraNscathetER Valves) trial with the NRCA (Nonrandomized Continued Access) registry.

This study sought to determine whether outcomes for transfemoral (TF) transcatheter aortic valve replacement (TAVR) differ between the randomized controlled trial (RCT) and the subsequent NRCA (Nonrandomized Continued Access) registry of the PARTNER (Placement of AoRTic TraNscathetER Valves) trial. The PARTNER RCT demonstrated that TAVR with the Edwards Sapien valve (Edwards Lifesciences, Irvine, California) is noninferior to surgery in high-risk patients and superior to standard therapy for inoperable patients. The inclusion and exclusion criteria, data collection, monitoring, and core laboratories were the same for the RCT and NRCA registry. Baseline characteristics, procedural results, and 1-year outcomes were compared between patients undergoing TF-TAVR as part of the RCT and as part of the NRCA registry. In the RCT, 415 patients underwent TF-TAVR, whereas in the NRCA, 1,023 patients did. At 30 days, death, cardiac death, stroke, and transient ischemic attacks were not different in the NRCA registry than in the RCT. Major vascular complications (8.0% vs. 15.7%, p < 0.0001) and major bleeding (6.8% vs. 15.3%, p < 0.0001) were significantly lower in the NRCA registry. At 1 year, death rates were significantly lower in the NRCA cohort (19.0% vs. 25.3%, p = 0.009) and cardiac death tended to be lower (8.4% vs. 11.1%, p = 0.12). Stroke or transient ischemic attack (6.2% vs. 8.7%, p = 0.10) and stroke alone (5.0% vs. 7.1%, p = 0.13) also tended to be lower. The large NRCA registry demonstrates further improvement in procedural and longer-term outcomes after TF-TAVR when compared with the favorable results from the PARTNER RCT. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

Fearon WF ，Kodali S ，Doshi D ，Fischbein MP ，Yeung AC ，Tuzcu EM ，Rihal CS ，Babaliaros V ，Zajarias A ，Herrmann HC ，Brown DL ，Mack M ，Teirstein PS ，Whisenant BK ，Makkar R ，Kapadia S ，Leon MB ，PARTNER Trial Investigators ... -  《-》

Conventional surgery, sutureless valves, and transapical aortic valve replacement: what is the best option for patients with aortic valve stenosis? A multicenter, propensity-matched analysis.

Although surgical aortic valve replacement (SAVR) is the treatment of choice for patients with aortic valve stenosis, transcatheter aortic valve replacement (TAVR) and sutureless aortic valve replacement (SU-AVR) have shown good results. The aim of our multicenter, propensity-matched study was to compare the clinical and hemodynamic outcomes of surgical SAVR, transapical TAVR (TA-TAVR), and SU-AVR. We analyzed data from 566 TA-TAVR, 349 SAVR, and 38 SU-AVR patients treated from January 2009 to March 2012. We used a propensity-matching strategy to compare on-pump (SAVR, SU-AVR) and off-pump (TA-TAVR) surgical techniques. The outcomes were analyzed using multivariate weighted logistic regression or multinomial logistic analysis. In the matched cohorts, the 30-day overall mortality was significantly lower after SAVR than TA-TAVR (7% vs 1.8%, P = .026), with no differences in mortality between SU-AVR and TA-TAVR. Multivariate analysis showed SU-AVR to have a protective effect, although not statistically significant, against aortic regurgitation, pacemaker implantation, and renal replacement therapy compared with TA-TAVR. Compared with TA-TAVR, SAVR demonstrated significant protection against aortic regurgitation (odds ratio, 0.04; P < .001) and a trend toward protection against death, pacemaker implantation, and myocardial infarction. The mean transaortic gradient was 10.3 ± 4.4 mm Hg, 11 ± 3.4 mm Hg, and 16.5 ± 5.8 mm Hg in the TA-TAVR, SU-AVR, and SAVR patients, respectively. SAVR was associated with lower 30-day mortality than TA-TAVR. SAVR was also associated with a lower risk of postoperative aortic regurgitation compared with TA-TAVR. We did not find other significant differences in outcomes among matched patients treated with SAVR, SU-AVR, and TA-TAVR.

D'Onofrio A ，Rizzoli G ，Messina A ，Alfieri O ，Lorusso R ，Salizzoni S ，Glauber M ，Di Bartolomeo R ，Besola L ，Rinaldi M ，Troise G ，Gerosa G ... -  《-》