Self-expanding valves were associated with higher peri-procedural complications and a higher 3-year mortality rate of 29.4% vs 20.4% compared to balloon-expandable valves, but multivariate analysis showed no significant mortality difference (HR 1.24, p=0.48).
Observational (n=552)
Yes
Does TAVR with self-expanding valves compared to balloon-expandable valves improve long-term mortality or reduce peri-procedural complications in male patients with large aortic annuli?
In male patients with large aortic annuli, TAVR with self-expanding valves yields similar long-term mortality to balloon-expandable valves, though it is associated with a higher risk of peri-procedural complications.
Effect estimate: log-rank p=0.02 (univariate); HR 1.24 (multivariate) (95% CI 0.68-2.27)
Absolute Event Rate: 29.4% vs 20.4%
p-value: p=0.02 (univariate), 0.48 (multivariate)
ABSTRACT Background Trans‐catheter aortic valve replacement (TAVR) in patients with large annuli poses procedural difficulties and possible complications. Aims We sought to compare the peri‐procedural and long‐term outcomes of patients with large annuli undergoing TAVR with self‐expanding (SEV) versus balloon‐expandable (BEV) valves. Methods We conducted propensity score matching (PSM) of consecutive male patients with large aortic annuli (aortic valve area ≥ 540 mm 2 ) enrolled in a national registry undergoing TAVR with SEVs and BEVs between 2008 and 2023. The cutoff for the large annulus was based on definitions set by the S3 manufacturer. Patients undergoing TAVR via the transapical route, for aortic regurgitation, and prior valve interventions were excluded. Results Overall, 552 patients were included in the current analysis (368 BEV; 184 SEV; age 80.2 ± 8.2 y/o). Baseline characteristics were similar between groups. The rate of peri‐procedural cardiopulmonary resuscitation (CPR) (3.9% vs. 0.6%; p = 0.013), hemodynamic instability (5.8% vs. 1.4%; p = 0.022), major or life‐threatening bleeding (7.7% vs. 2.8%; p = 0.015) and need for a second valve (3.8% vs. 0.3%) was higher in the SEV versus BEV group. In univariate analysis the 3‐year mortality rate was higher in the SEV versus BEV group (29.4% vs. 20.4%; log rank p = 0.02). However, multivariate analysis adjusted for known confounders related to mortality did not show a significant difference between groups. Conclusions Male patients with large aortic annuli undergoing TAVR with either SEV or BEV have similar rates of in‐hospital and long‐term mortality, albeit a notably higher rate of peri‐procedural complications related to SEVs.
Zornitzki et al. (Sun,) conducted a observational in Severe symptomatic aortic stenosis with large aortic valve annuli (n=552). Self-expanding valves (SEV) vs. Balloon-expandable valves (BEV) was evaluated on All-cause mortality at 3 years (log-rank p=0.02 (univariate); HR 1.24 (multivariate), 95% CI 0.68-2.27, p=0.02 (univariate), 0.48 (multivariate)). Self-expanding valves were associated with higher peri-procedural complications and a higher 3-year mortality rate of 29.4% vs 20.4% compared to balloon-expandable valves, but multivariate analysis showed no significant mortality difference (HR 1.24, p=0.48).
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