Efficacy and safety of transcatheter aortic valve replacement for the treatment of pure severe native aortic valve regurgitation: A single-arm meta-analysis

Abstract

Objective: Numerous studies have reported the efficacy and safety of transcatheter aortic valve replacement (TAVR) for pure severe native aortic valve regurgitation (psNAVR) in recent years; however, these studies show considerable variability in outcomes such as success rate and mortality. Therefore, this meta-analysis was conducted to evaluate the efficacy and safety of TAVR in patients with psNAVR based on the latest research evidence. Methods: Relevant studies were searched in four databases—PubMed, Embase, Web of Science, and the Cochrane Library—up to August 27, 2025. The primary outcomes were device success, all-cause mortality, and cardiovascular mortality during the perioperative period. Secondary outcomes included perioperative and one-year postoperative adverse events, such as stroke, acute kidney injury (AKI), new-onset myocardial infarction, major vascular complications, major bleeding events, readmission due to heart failure (HF), and new permanent pacemaker (PPM) implantation. Statistical analyses were performed using Stata 14.0 software. Results: A total of 29 articles involving 2,773 patients with psNAVR undergoing TAVR were included in the meta-analysis. The device success rate was 87.5% (95% confidence interval [CI]: 83.3%–91.2%). Perioperative all-cause mortality was 3.1% (95% CI: 1.6%–5.1%), and perioperative cardiovascular mortality was 1.4% (95% CI: 0.2%–3.5%). During the perioperative period, the incidence of adverse events was as follows: stroke, 0.7%; AKI, 4.5%; new-onset myocardial infarction, 0.0%; major vascular complications, 3.3%; major bleeding events, 4.4%; and new PPM implantation, 11.4%. At one year, the incidence rates were 9.3% for all-cause mortality, 4.3% for cardiovascular mortality, 2.6% for stroke, 9.1% for AKI, 0.0% for new-onset myocardial infarction, 1.6% for major bleeding events, 19.0% for readmission due to HF, and 10.0% for new PPM implantation. Subgroup analysis indicated that geographic location, surgical risk, valve type, and procedural approach influenced the incidence of postoperative adverse events. Conclusion: TAVR is a valuable therapeutic option for patients with psNAVR at high surgical risk. However, geographic location, surgical risk, valve type, and procedural approach appear to influence the incidence of adverse events after TAVR.