Synapse
⌘+K
Synapse
PulseExploreClubsResearchersJournals
Instagram
HomeClubsExplore
July 24, 2026Structural HeartOpen Access

Early nonfatal TAVI complications are linked to ~114% higher 1-year mortality among 30-day survivors.

View Full Paper
Ask AI
Bookmark
Share

Why the study?

The impact of early nonfatal complications on subsequent mortality and quality of life after contemporary TAVI remains unclear.

Do early nonfatal complications after TAVI increase 1-year mortality or affect quality of life in patients with severe aortic stenosis?

Population

Patients with severe aortic stenosis undergoing TAVI surviving first 30 days in LANDMARK trial

Comparison

Early nonfatal complications within 30 days after TAVI vs no early nonfatal complications

Design

Post-hoc substudy of randomized trial comparing Myval THV series vs contemporary THV series

Follow-up

1 year

Key result

Early nonfatal complications within 30 days after transcatheter aortic valve implantation were independently associated with increased 1-year mortality (HR 2.14) among 30-day survivors.

Authors

ATAkihiro TobeOllscoil na Gaillimhe – University of GalwayYOYoshinobu OnumaNRNiels van RoyenRadboud University Nijmegen

Discussion

Loading...

Member takes

Overview

May warrant closer surveillance after TAVI; observational data leave open whether preventing complications improves survival.

Study Design

Type

Cohort (n=742)

Blinding

Open-label

Multicenter

Yes

Structured PICO

Do early nonfatal complications after TAVI increase 1-year mortality or affect quality of life in patients with severe aortic stenosis?

P
Population
742 adults with symptomatic severe native aortic stenosis who underwent transcatheter aortic valve implantation and survived to 30 days, followed for 1 year.
E
Exposure
Occurrence of early nonfatal complications within 30 days after TAVI (stroke, type 3 bleeding, major vascular complications, acute kidney injury stages 2-4, moderate or severe aortic regurgitation, new permanent pacemaker implantation, or reintervention).
C
Comparator
No early nonfatal complications within 30 days after TAVI.
O
Outcome
All-cause mortality from 30 to 365 days.hard clinical

Main Result

Hazard Ratio: 2.14 (95% CI 1.07–4.27)

Absolute Event Rate: 8% vs 3.9%

p-value: p=0.03

Early nonfatal complications after TAVI are associated with higher 1-year mortality but do not appear to impact 1-year quality of life among 30-day survivors.

Limitations

  • Post-hoc substudy with non-prespecified analyses, increasing risk of type I error
  • Small number of patients with specific complications limited statistical power
  • Use of generic SF-12 questionnaire instead of disease-specific KCCQ for quality of life assessment
  • Restriction to 30-day survivors may have introduced survivorship bias
  • Type 2 bleeding was not included in the early safety endpoint despite VARC-3 recommendations
  • post-hoc analysis
  • hypothesis-generating
  • potential survivor bias

Cite This Study

Tobe et al. (2026) conducted a cohort in Severe aortic stenosis (n=742). Early nonfatal complications vs. No early nonfatal complications was evaluated on All-cause mortality from 30 to 365 days (HR 2.14, 95% CI 1.07-4.27, p=0.03). Early nonfatal complications within 30 days after transcatheter aortic valve implantation were independently associated with increased 1-year mortality (HR 2.14) among 30-day survivors.

synapsesocial.com/papers/6aaa30145e1c2e91a8fbd217https://doi.org/10.1016/j.shj.2026.101101
View Full Paper
Ask AI
Bookmark
Share

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Cardiac damage and 1-year clinical outcomes after transcatheter aortic valve implantation: substudy of the LANDMARK trial2026
  2. 2Quality-of-Life Outcomes After Transcatheter Aortic Valve Implantation in a “Real World” Population: Insights From a Prospective Canadian Database2021 · 24 citations
  3. 3Factors influencing quality-of-life improvement following transcatheter aortic valve implantation: insights from a prospective study with mixed-effects analysis2025 · 1 citations
  4. 4Quality of life improvement is maintained up to two years after transcatheter aortic valve implantation in high-risk surgical candidates2012 · 25 citations
  5. 5Quality of life in patients with transcatheter aortic valve implantation: an analysis from the INTERVENT project2023 · 7 citations