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Okuno, T; Dangas, GD; Hengstenberg, C; Sartori, S; Herrmann, HC; de, Winter, R; Gilard, M; Tchétché, D; Möllmann, H; Makkar, RR; Baldus, S; De, Backer, O; Bendz, B; Kini, A; von, Lewinski, D; Mack, M; Moreno, R; Schäfer, U; Wöhrle, J; Seeger, J; Snyder, C; Nicolas, J; Tijssen, JGP; Welsh, RC; Vranckx, P; Valgimigli, M; Mehran, R; Kapadia, S; Sondergaard, L; Windecker, S.
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; 100(4): 636-645. Doi: 10.1002/ccd.30370
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von Lewinski Dirk

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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.
Find related publications in this database (using NLM MeSH Indexing)
Aortic Valve - diagnostic imaging, surgery
Aortic Valve Stenosis - diagnostic imaging, etiology, surgery
Female - administration & dosage
Heart Valve Prosthesis - administration & dosage
Hemoglobins - administration & dosage
Humans - administration & dosage
Male - administration & dosage
Prosthesis Design - administration & dosage
Stroke - etiology
Transcatheter Aortic Valve Replacement - adverse effects, methods
Treatment Outcome - administration & dosage

Find related publications in this database (Keywords)
aortic valve setenosis
balloon-expandable valve
major adverse cardiac and cerebrovascular events
self-expanding valve
successful implantation
transcatheter aortic valve implantation
transcatheter heart valve
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