Abstract Body (Do not enter title and authors here): Background
There are two approved methods for transcatheter aortic valve replacement (TAVR) namely balloon-expandable valves (BEV) and self-expanding valves (SEV). While several randomized controlled trials (RCTs) have compared the efficacy of SEV and BEV, the generalizability of their findings is questioned. Therefore, to generate concrete evidence regarding the superiority between the two, we conducted this real-world meta-analysis to compare the clinical efficacy and safety outcomes of SEV vs BEV in patients undergoing TAVR for aortic stenosis (AS).
Methods
MEDLINE, EMBASE, and Scopus were queried to shortlist studies including AS patients undergoing TAVR. Primary outcomes included 30-day and 1-year all-cause and cardiac mortality. Secondary outcomes were permanent pacemaker implantation (PPI), paravalvular leak (PVL), aortic regurgitation (AR), stroke, major vascular complications (MVC), major bleeding (MB), acute kidney injury (AKI), myocardial infarction (MI), length of stay (LOS), patient prosthesis mismatch (PPM), and atrial fibrillation (AF). A random effects meta-analysis was conducted to derive risk ratios and mean differences with corresponding 95% confidence intervals (CI).
Results: Our meta-analysis included 38 real-world studies. No significant association was seen in 30-day (RR=1.13, P=0.15) and 1-year all-cause mortality (RR=1.04, P=0.55), and cardiac mortality (RR=1.28, P=0.12). SEV was associated with a higher risk of 30-day PPI (RR=1.61, 95% CI 1.28-2.02, I2 = 88%, P<0.0001), mild PVL (RR=1.52, 95% CI 1.17-1.97, I2=76%, P=0.002), and moderate to severe PVL (RR=1.97, 95% CI 1.43-2.72, I2=51%, P<0.0001). Patients in the SEV group experienced more statistically significant AR (RR=1.72, 95% CI 1.29-2.30, I2=27%, P=0.0002), and 30-day MVC (RR=1.1, 95% CI 1.02-1.2, I2=0%, P=0.02) when compared to the BEV group. No statistically significant association was established for stroke, MB, AKI, MI, LOS, PPM, and AF.
Conclusion
Our real-world analysis showed that SEV increases the risk of PPI, PVL, AR, and MVC. However, all-cause and cardiovascular mortality were comparable between both groups. Our results confirm the conclusions drawn from RCTs, thus reassuring decision-makers that these findings can be extrapolated to real-world populations.