ArticleStructural heart : the journal of the Heart Team2026
Impact of Early Nonfatal Complications After Transcatheter Aortic Valve Implantation on 1-Year Mortality and Quality of Life: Insights From the LANDMARK Trial.
Article in Structural heart : the journal of the Heart Team, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04275726 (A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve), which is not on this map. Cited by 1 paper.
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A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series vs. Contemporary Valves (Edwards's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis
Who cites it
1 citing paper in PubMed.
- Redefining Procedural Success After Transcatheter Aortic Valve Implantation: Why Nonfatal Complications Matter.Structural heart : the journal of the Heart Team · 2026Article
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40 authors.
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No grant is acknowledged in the PubMed record.
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, 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.
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