Okuno, Taishi ORCID: 0000-0001-7831-2934, Dangas, George D., Hengstenberg, Christian ORCID: 0000-0002-8284-2994, Sartori, Samantha ORCID: 0000-0003-0618-9409, Herrmann, Howard C., de Winter, Robert, Gilard, Martine, Tchetche, Didier, Moellmann, Helge, Makkar, Raj R., Baldus, Stephan, De Backer, Ole, Bendz, Bjorn, Kini, Annapoorna, von Lewinski, Dirk, Mack, Michael, Moreno, Raul, Schaefer, Ulrich, Woehrle, Jochen, Seeger, Julia, Snyder, Clayton, Nicolas, Johny, Tijssen, Jan G. P., Welsh, Robert C., Vranckx, Pascal, Valgimigli, Marco, Mehran, Roxana, Kapadia, Samir, Sondergaard, Lars and Windecker, Stephan (2022). 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., 100 (4). S. 636 - 646. HOBOKEN: WILEY. ISSN 1522-726X

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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: . 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Okuno, TaishiUNSPECIFIEDorcid.org/0000-0001-7831-2934UNSPECIFIED
Dangas, George D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hengstenberg, ChristianUNSPECIFIEDorcid.org/0000-0002-8284-2994UNSPECIFIED
Sartori, SamanthaUNSPECIFIEDorcid.org/0000-0003-0618-9409UNSPECIFIED
Herrmann, Howard C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Winter, RobertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gilard, MartineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tchetche, DidierUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moellmann, HelgeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Makkar, Raj R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baldus, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
De Backer, OleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bendz, BjornUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kini, AnnapoornaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Lewinski, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mack, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moreno, RaulUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schaefer, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Woehrle, JochenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seeger, JuliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Snyder, ClaytonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nicolas, JohnyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tijssen, Jan G. P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Welsh, Robert C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vranckx, PascalUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Valgimigli, MarcoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mehran, RoxanaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kapadia, SamirUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sondergaard, LarsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Windecker, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-696716
DOI: 10.1002/ccd.30370
Journal or Publication Title: Catheter. Cardiovasc. Interv.
Volume: 100
Number: 4
Page Range: S. 636 - 646
Date: 2022
Publisher: WILEY
Place of Publication: HOBOKEN
ISSN: 1522-726X
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
REPLACEMENTMultiple languages
Cardiac & Cardiovascular SystemsMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69671

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