TY - JOUR
T1 - Two-year clinical outcomes after successful transcatheter aortic valve implantation with balloon-expandable versus self-expanding valves
T2 - A subanalysis of the GALILEO trial
AU - Okuno, Taishi
AU - Dangas, George D
AU - Hengstenberg, Christian
AU - Sartori, Samantha
AU - Herrmann, Howard C
AU - de Winter, Robert
AU - Gilard, Martine
AU - Tchétché, Didier
AU - Möllmann, Helge
AU - Makkar, Raj R
AU - Baldus, Stephan
AU - De Backer, Ole
AU - Bendz, Bjørn
AU - Kini, Annapoorna
AU - von Lewinski, Dirk
AU - Mack, Michael
AU - Moreno, Raúl
AU - Schäfer, Ulrich
AU - Wöhrle, Jochen
AU - Seeger, Julia
AU - Snyder, Clayton
AU - Nicolas, Johny
AU - Tijssen, Jan G P
AU - Welsh, Robert C
AU - Vranckx, Pascal
AU - Valgimigli, Marco
AU - Mehran, Roxana
AU - Kapadia, Samir
AU - Sondergaard, Lars
AU - Windecker, Stephan
N1 - © 2022 Wiley Periodicals LLC.
PY - 2022/10
Y1 - 2022/10
N2 - 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.
AB - 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.
KW - Aortic Valve Stenosis/diagnostic imaging
KW - Aortic Valve/diagnostic imaging
KW - Female
KW - Heart Valve Prosthesis
KW - Hemoglobins
KW - Humans
KW - Male
KW - Prosthesis Design
KW - Stroke/etiology
KW - Transcatheter Aortic Valve Replacement/adverse effects
KW - Treatment Outcome
KW - transcatheter aortic valve implantation
KW - major adverse cardiac and cerebrovascular events
KW - GALILEO
KW - transcatheter heart valve
KW - balloon-expandable valve
KW - successful implantation
KW - self-expanding valve
KW - aortic valve setenosis
UR - http://www.scopus.com/inward/record.url?scp=85137335601&partnerID=8YFLogxK
U2 - 10.1002/ccd.30370
DO - 10.1002/ccd.30370
M3 - Journal article
C2 - 36040717
SN - 1522-1946
VL - 100
SP - 636
EP - 645
JO - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
JF - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
IS - 4
ER -