Two-year clinical outcomes after successful transcatheter aortic valve implantation with balloon-expandable versus self-expanding valves: A subanalysis of the GALILEO trial

Catheter Cardiovasc Interv. 2022 Oct;100(4):636-645. doi: 10.1002/ccd.30370. Epub 2022 Aug 30.

Abstract

Background: Midterm data comparing clinical outcomes after successful implantation of self-expanding and balloon-expandable transcatheter heart valves (THV) are limited. We aimed to compare 2-year outcomes after successful transcatheter aortic valve implantation (TAVI) with the Edwards balloon-expandable or the Medtronic self-expanding THV.

Methods: Two-year outcomes were analyzed according to the implanted THV in the GALILEO trial. Major adverse cardiac and cerebrovascular events (MACCE) was a composite of all-cause death or thromboembolic events including stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep-vein thrombosis, or pulmonary embolism.

Results: Among 1644 patients recruited in 136 centers across 16 countries between 2015 and 2018, 499 received a self-expanding and 757 patients received a balloon-expandable THV. Patients treated with a self-expanding THV were more likely to be female, and had higher surgical risk, lower hemoglobin levels, and more frequent valve-in-valve procedures than those with a balloon-expandable THV. After multivariable adjustment, there were no significant differences in major clinical outcomes between self-expanding versus balloon-expandable THV: MACCE (17.0% vs. 13.4%, adjusted-hazard ratios [HR] 1.18, 95% confidence intervals [CI]: 0.82-1.69); all-cause death (11.4% vs. 9.3%, adjusted-HR 1.26; 95% CI: 0.78-2.05); cardiovascular death (8.5% vs. 4.0%, adjusted-HR 1.53; 95% CI: 0.82-2.86), any stroke (5.1% vs. 3.7%, adjusted-HR 0.86; 95% CI: 0.43-1.73); major or life-threatening bleeding (5.9% vs. 6.8%, adjusted-HR 0.93; 95% CI: 0.53-1.63).

Clinical trial registration: https://www.

Clinicaltrials: gov. NCT02556203.

Conclusions: Two-year follow-up data from the GALILEO trial indicate that successful TAVI either with self-expanding or balloon-expandable THVs according to physician discretion did not show difference in rates of MACCE.

Keywords: GALILEO; aortic valve setenosis; balloon-expandable valve; major adverse cardiac and cerebrovascular events; self-expanding valve; successful implantation; transcatheter aortic valve implantation; transcatheter heart valve.

Publication types

  • Clinical Trial

MeSH terms

  • Aortic Valve / diagnostic imaging
  • Aortic Valve / surgery
  • Aortic Valve Stenosis* / diagnostic imaging
  • Aortic Valve Stenosis* / etiology
  • Aortic Valve Stenosis* / surgery
  • Female
  • Heart Valve Prosthesis*
  • Hemoglobins
  • Humans
  • Male
  • Prosthesis Design
  • Stroke* / etiology
  • Transcatheter Aortic Valve Replacement* / adverse effects
  • Transcatheter Aortic Valve Replacement* / methods
  • Treatment Outcome

Substances

  • Hemoglobins

Associated data

  • ClinicalTrials.gov/NCT02556203