Incidence, predictors, and prognostic impact of new permanent pacemaker implantation after TAVR with self-expanding valves

OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BACKGROUND: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. METHODS: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. RESULTS: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). CONCLUSIONS: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.

Balloon-expandable or self-expandable valves in valve-in valve transcatheter aortic valve implantation?

BACKGROUND Bioprosthetic valves are increasingly implanted in patients with aortic valve stenosis. These valves have a limited durability. Valve-in-valve (ViV) transcatheter aortic valve implanta tion (TAVI) is a treatment option for bioprosthetic valve failure. Both balloon-expandable (BE) and self-expandable (SE) valves are widely used in ViV-TAVI procedures. However, studies comparing outcomes between these fundamentally different valve designs in ViV-TAVI are lacking. METHODS The CENTER study is a patient pooled analysis, comprising data of 12,381 patients undergoing transfemoral TAVI in 6 countries. We assessed differences in clinical outcomes between SE and BE valves in ViV-TAVI patients, as defined by the Valve Academic Research Consortium. RESULTS A total of 256 patients were treated with transfemoral ViV TAVI. Of these, 50% were female, median age was 82 (IQR: 78-85) years, and median STS-PROM was 6.3% (IQR: 4.0%-10.4%). SE valves were used in 162 patients (63%) and BE valves in 94 (37%) patients. SE and BE valve recipients were similar regarding female sex (53% vs 47%; P » 0.38), age (82 years [78-85] vs 81 [78-84]; P » 0.24), and STS PROM (6.5% [4.2%-10.2%] vs 6.2% [4.0%-10.9%]; P » 1.00). Third generation valves were used in 91 (56%) of SE valves and in 40 (43%) of BE valves. There was a trend towards lower 30-day mortality in SE valve patients (3% vs 7%; RR: 0.37; 95% CI: 0.11-1.26; P » 0.10). In addition, 30-day major bleeding was less frequent in SE valve patients (3% vs 13%; RR: 0.27; 95% CI: 0.09-0.79; P » 0.01). Rates of conversion to surgery (1% vs 0; P » 0.44) and device success were similar (90% vs 92%; P » 0.62). Moreover, 30-day rates of stroke (1.9% vs 4.6%; P » 0.22), myocardial infarction (0.7% vs 1.8%; P » 0.46), and permanent pacemaker implantation (9.3% vs 7.9%; P » 0.70) were similar. There was no difference in 1-year mortality (12.5% vs 17.6%; P » 0.32) and stroke rates (3.7% vs 7.4%; P » 0.25). CONCLUSION There was a trend toward lower 30-day mortality in ViV-TAVI patients treated with SE valves. Moreover, the use of SE valves in ViV-TAVI was associated with lower rates of major bleeding than BE valves. Our findings warrant randomized controlled trials directly comparing SE and BE valves in ViV-TAVI patients.

Atrial fibrillation in patients undergoing transcatheter aortic valve implantation is associated with increased mortality

BACKGROUND Atrial fibrillation (AF) is common in patients with aortic valve stenosis undergoing transcatheter aortic valve implanta tion (TAVI). We compared clinical outcomes between TAVI patients with baseline AF versus TAVI patients without AF. METHODS The CENTER study is an international collaboration including 12,381 patients treated with transfemoral TAVI. This pooled analysis consists of patient level data from 10 different studies. End points were stroke and mortality rates at 30 days and 1 year after TAVI as defined by the Valve Academic Research Consortium. RESULTS Of the 12,381 patients, 58% were female, the mean age was 81.5 7.0 years, and the median logistic EuroSCORE was 14.4% (9.0%- 23.0%). A total of 3,354 patients (27%) had known baseline AF. In patients with AF, there was a trend toward higher in-hospital mor tality (5.3% vs 3.5%; relative risk [RR]: 1.18; 95% confidence interval [CI]: 0.99-1.41; P » 0.06). Moreover, 30-day mortality (7.1% vs 5.3%; RR: 1.35; 95% CI: 1.16-1.59; P < 0.001) as well as 1-year mortality (20.8% vs 15.3%; RR: 1.35; 95% CI: 1.23-1.52; P < 0.001) was higher in AF patients. In contrast, stroke rates were comparable in patients with versus without AF during hospital admission (2.2% vs 2.0%, P » 0.60), at 30 days (2.9% vs 2.4%, P » 0.18), and 1 year after TAVI (5.3% vs 5.1%, P » 0.75). Also, 30-day rates of myocardial infarction (0.8% vs 1.0%, P » 0.38) and major bleeding (7.6% vs 7.3%, P » 0.53) were similar between both patient groups. However, permanent pace makers were more frequently implanted in AF patients (14.8% vs 13.4%; RR: 1.11; 95% CI: 1.00-1.23; P » 0.05). CONCLUSION In this global study of >12,000 patients undergoing transfemoral TAVI, AF was associated with higher 30-day and 1-year mortality. Moreover, patients with AF more frequently required a permanent pacemaker. Although AF is a common condition in pa tients undergoing TAVI, it is undoubtedly not a benign arrhythmia. Therefore, our results underscore the evident need for further research in treatment options for patients with AF undergoing TAVI.

Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration

AIMS: The aim of this study was to compare clinical outcomes of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with balloon-expandable (BE) valves vs. self-expandable (SE) valves. Transcatheter aortic valve implantation is a minimally invasive and lifesaving treatment in patients with aortic valve stenosis. Even though BE-valves and SE-valves are both commonly used on a large scale, adequately sized trials comparing clinical outcomes in patients with severe aortic valve stenosis treated with BE-valves compared with SE-valves are lacking. METHODS AND RESULTS: In this CENTER-collaboration, data from 10 registries or clinical trials, selected through a systematic search, were pooled and analyzed. Propensity score methodology was used to reduce treatment selection bias and potential confounding. The primary endpoints were mortality and stroke at 30 days follow-up in patients treated with BE-valves compared with SE-valves. Secondary endpoints included clinical outcomes, e.g. bleeding during hospital admission. All outcomes were split for early-generation BE-valves compared with early-generation SE-valves and new-generation BE-valves with new-generation SE-valves. The overall patient population (N = 12 381) included 6239 patients undergoing TAVI with BE-valves and 6142 patients with SE-valves. The propensity matched population had a mean age of 81 ± 7 years and a median STS-PROM score or 6.5% [interquartile range (IQR) 4.0-13.0%]. At 30-day follow-up, the mortality rate was not statistically different in patients undergoing TAVI with BE-valves compared with SE-valves [BE: 5.3% vs. SE: 6.2%, relative risk (RR) 0.9; 95% confidence interval (CI) 0.7-1.0, P = 0.10]. Stroke occurred less frequently in patients treated with BE-valves (BE: 1.9% vs. SE: 2.6%, RR 0.7; 95% CI 0.5-1.0, P = 0.03). Also, patients treated with BE-valves had a three-fold lower risk of requiring pacemaker implantation (BE: 7.8% vs. SE: 20.3%, RR 0.4; 95% CI 0.3-0.4, P < 0.001). In contrast, patients treated with new-generation BE-valves more frequently experienced major and life-threatening bleedings compared with new-generation SE-valves (BE: 4.8% vs. SE: 2.1%, RR 2.3; 95% CI 1.6-3.3, P < 0.001). CONCLUSION: In this study, which is the largest study to compare valve types in TAVI, we demonstrated that the incidence of stroke and pacemaker implantation was lower in patients undergoing transfemoral TAVI with BE-valves compared with SE-valves. In contrast, patients treated with new-generation BE-valves more often suffered from major or life-threatening bleedings than patients with new-generation SE-valves. Mortality at 30-days was not statistically different in patients treated with BE-valves compared with SE-valves. This study was a propensity-matched analysis generated from observational data, accordingly current outcomes will have to be confirmed in a large scale randomized controlled trial. (AU)