Results of a pooled analysis comparing outcomes of transcatheter aortic valve replacement (TAVR) suggest lower odds of device success and early safety with self-expanding valves (SEV) versus balloon-expandable valves (BEV). Data from 6,097 patients found that the odds of device success were lower with SEV vs. BEV (odds ratio [OR]: 0.76; 95% confidence interval [CI]: 0.59-0.97), as were the odds of early safety (OR: 0.55; 95% CI: 0.45-0.67). While this suggests that BEV may offer better initial procedural success and safety compared to SEV, Pier Pasquale Leone, MD, Interventional Cardiologist at the Montefiore Medical Center in New York, said there were some advantages of SEV. “The odds of 30-day mean trans-aortic gradient >20 mmHg (OR: 0.14; 95% CI: 0.07-0.26) and 30-day prosthesis-patient mismatch (OR: 0.32; 95% CI: 0.24-0.42) were lower with SEV than BEV," he said during a Late-Breaking Clinical Science presentation at Cardiovascular Research Technologies (CRT) 2025 meeting. BEV and SEV devices During Monday’s Late-Breaking Clinical Science Structural II session, Dr. Leone outlined details of the study where patients were treated with either BEV (Sapien 3 ULTRA, Edwards Lifesciences) or SEV (Navitor, Abbott; Evolut PRO/PRO+, Medtronic; Acurate Neo 2, Boston Scientific). Despite the hemodynamic benefits, the study also raised concerns about safety with SEV. "An increased risk of moderate or more paravalvular leak at 30 days was observed with SEV vs. BEV (OR: 3.51; 95% CI: 1.71-7.20)," Dr. Leone said. “The current pooled analysis of observational studies suggests lower odds of device success and early safety with SEV vs. BEV,” he added. “[This was] driven by an increased risk of paravalvular leak and permanent pacemaker implantation. Nonetheless, forward-flow hemodynamics is more favorable after SEV than BEV." Research methodology The study was a pooled analysis of data from the NAVULTRA and NEOPRO2 registries - two observational, retrospective, multicenter, investigator-driven cohort studies. A total of 6,097 patients were included in the analysis: 2,176 patients treated with BEV (Sapien 3 ULTRA, Edwards Lifesciences) and 3,921 patients treated with SEV (Navitor, Abbott; Evolut PRO/PRO+, Medtronic; Acurate Neo 2, Boston Scientific). The primary efficacy outcome was defined as Valve Academic Research Consortium-3 (VARC-3) device success, which included successful valve deployment, proper positioning and absence of significant complications. The primary safety outcome was defined as early safety, as defined by VARC-3 criteria, which includes mortality, stroke, and other major complications within 30 days. Image Credit: Bailey G. Salimes Image Caption: Pier Pasquale Leone, MD, presents during a Late-Breaking Clinical Science session at Cardiovascular Research Technologies (CRT) 2025.