Struct Heart. 2026 Jul 24;10(9):101101. doi: 10.1016/j.shj.2026.101101. eCollection 2026 Sep.
ABSTRACT
BACKGROUND: The impact of early nonfatal complications on subsequent mortality and quality of life (QOL) after contemporary transcatheter aortic valve implantation (TAVI) remains unclear.
METHODS: This post-hoc substudy of the LANDMARK trial included patients with severe aortic stenosis randomized to the Myval transcatheter heart valve (THV) series or to contemporary THV (Sapien or Evolut) series. Early nonfatal complications were defined as events occurring within 30 days after TAVI in patients surviving the first 30 days and included stroke, type 3 bleeding, major vascular complications, acute kidney injury stages 2-4, moderate or severe aortic regurgitation, new permanent pacemaker implantation, or reintervention according to the VARC-3 early safety endpoint. The primary endpoint was all-cause mortality from 30 to 365 days. QOL was assessed using the Short Form-12 at baseline, 30 days, and 1 year.
RESULTS: Of the 768 randomized patients, 742 were alive at 30 days. Of these, 177 (23.9%) experienced at least 1 early nonfatal complication, whereas 565 (76.1%) did not. Age (80 ± 5 years vs. 80 ± 6 years, p = 0.67) and Society of Thoracic Surgeons score (median 2.6 [interquartile range: 1.6-3.9] vs. 2.6 [1.7-3.9], p = 0.76) were similar between groups. Patients with early nonfatal complications had higher mortality between 30 and 365 days (8.0% vs. 3.9%, p = 0.03). Early nonfatal complications were independently associated with increased 1-year mortality (hazard ratio = 2.14; 95% CI, 1.07-4.27; p = 0.03). One-year QOL did not differ between groups.
CONCLUSIONS: In this post-hoc, hypothesis-generating analysis, early nonfatal complications after TAVI were associated with increased 1-year mortality, whereas 1-year QOL was comparable among survivors; findings should be interpreted with caution due to potential survivor bias.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT04275726.
PMID:42701683 | PMC:PMC13545709 | DOI:10.1016/j.shj.2026.101101