Evaluating Third Generation Valve System Performance and Pacemaker Implantation Variability After Transcatheter Aortic Valve Replacement

Abstract

Abstract Background: The choice of transcatheter aortic valve replacement (TAVR) prosthesis is crucial in optimizing short- and long-term outcomes. Objective: To conduct a meta-analysis comparing outcomes of 3rd generation balloon- expandable valves (BEV) vs. self-expanding valves (SEV). Methods: Electronic databases were searched from inception to June 2023 for studies comparing 3rd generation BEV vs. SEV. Primary outcome was all-cause mortality. Secondary outcomes included clinical and hemodynamic end points. Random effects models were used to calculate pooled odds ratios (ORs) or weighted mean differences (WMDs). Results: The meta-analysis included 16 studies and 10,174 patients (BEV: 5,753 and SEV: 4,421). There were no significant differences in 1-year all-cause mortality (OR 1.15, 95% CI 0.89-1.48) between 3rd generation BEV vs. SEV. TAVR with 3rd generation BEV was associated with a significantly lower risk of TIA/stroke (OR 0.62, 95% CI 0.44- 0.87), permanent pacemaker implantation (PPI, OR 0.55, 95% CI 0.44-0.70), and ≥moderate paravalvular leak (PVL, OR 0.43, 95% CI 0.25-0.75), and higher risk of ≥moderate patient-prosthesis mismatch (PPM, OR 3.76, 95% CI 2.33-6.05), higher mean gradient (WMD 4.35, 95% CI 3.63 to 5.08), and smaller effective orifice area (EOA, WMD -0.30, 95% CI -0.37 to -0.23), compared with SEV. Conclusion: In this meta-analysis, TAVR with 3rd generation BEV vs. SEV was associated with similar all-cause mortality, lower risk of TIA/stroke, PPI, and ≥moderate PVL, but higher risk of ≥moderate PPM, higher mean gradient, and smaller EOA. Large, adequately powered randomized trials are needed to evaluate long-term outcomes of TAVR with latest generations of BEV vs. SEV.

Abstract Background: Permanent pacemaker implantation (PPI) remains the most common complication after transcatheter aortic valve replacement (TAVR). Methods: We analyzed data from the 2019 Nationwide Readmissions Database to identify 34,830 patients who underwent TAVR across 398 hospitals. The primary outcome of interest was new PPI in-hospital or within 30 days post-discharge. Mixed effects logistic regression models were used to examine hospital-level variation in rates and timing (in-hospital vs. post-discharge) of new PPI after TAVR. Results: The overall PPI rate was 9.9% (84.5% in-hospital and 15.5% post-discharge). The median (IQR) hospital-level PPI rate was 8.7% (5.4% to 12.9%) with wide variation across hospitals (range: 0% to 54.5%). Similarly, there was substantial hospital-level variation in the timing of PPI. The median (IQR) proportion of post-discharge PPI at the hospital level was 13.3% (0% to 25.0%), ranging from 0% to 100%. After adjusting for patient-level covariates, there was significant hospital variation in PPI rates (median OR: 1.49; 95% CI: 1.41-1.58) and timing (median OR: 1.54; 95% CI: 1.26-1.82), which persisted even after addition of hospital-level covariates to the model. Conclusions: Approximately 1 in 10 patients underwent PPI after TAVR, and 15% of PPI were performed post-discharge. There is substantial hospital-level variation in rates and timing of PPI after TAVR, which is not entirely explained by differences in patient and hospital characteristics. Future studies are needed to understand the reasons underlying hospital variation in PPI, and to identify evidence-based practices and processes of care associated with decreased risk of PPI post-TAVR.