Universität zu Köln

Strauch, Justus, Wendt, Daniel, Diegeler, Anno, Heimeshoff, Martin, Hofmann, Steffen, Holzhey, David ORCID: 0000-0002-0613-4419, Oertel, Frank, Wahlers, Thorsten, Kurucova, Jana, Thoenes, Martin, Deutsch, Cornelia, Bramlage, Peter and Schroefel, Holger (2018). Balloon-expandable transapical transcatheter aortic valve implantation with or without predilation of the aortic valve: results of a multicentre registry. Eur. J. Cardio-Thorac. Surg., 53 (4). S. 771 - 778. CARY: OXFORD UNIV PRESS INC. ISSN 1873-734X

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Abstract

OBJECTIVES: To assess safety and efficacy of transapical transcatheter aortic valve implantation (TA-TAVI) in the absence of predilation using balloon aortic valvuloplasty (BAV). Predilation of the stenosed valve using BAV is a routine step in TA-TAVI; however, evidence supporting its clinical value is lacking, and several studies have linked it with higher complication rates.& para;& para;METHODS: A prospective, two-armed, multicentre registry (EASE-IT TA) to gather data on patients undergoing TA-TAVI with or without BAV, using the Edwards SAPIEN 3 valve was designed. The primary evaluation criterion was a composite of all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, acute kidney injury and pacemaker implantation [per Valve Academic Research Consortium-2 (VARC-2)] within 30 days after TAVI.& para;& para;RESULTS: A total of 198 subjects underwent TA TAVI, 61 with and 137 without BAV. Patient characteristics were comparable at baseline (mean +/- SD: age 80.3 +/- 5.7 years; logistic EuroSCORE 20.2 +/- 12.6). Similar reductions in peak and mean transvalvular gradients were observed post-procedurally. There was a significant reduction of fluoroscopy time without BAV (4.7 vs 7.9 min; P = 0.039) and significantly decreased odds of catecholamine administration (17.5% vs 32.8%; P = 0.017). A decreased odds of the primary evaluation criterion in patients without BAV after 30 days (adjusted odds ratio 0.71; 95% confidence interval 0.34-1.82) and the same composite end-point after 6 months (adjusted odds ratio 0.74; 95% confidence interval 0.37-1.47) were not significant even after multivariable adjustment.& para;& para;CONCLUSIONS: TA-TAVI without BAV appears to be at least equal to its conventional counterpart in terms of efficacy and may offer advantages in terms of safety. Thus, there appears to be little justification for maintaining the BAV step in TA-TAVI for many patients.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Strauch, Justus UNSPECIFIED UNSPECIFIED UNSPECIFIED Wendt, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED Diegeler, Anno UNSPECIFIED UNSPECIFIED UNSPECIFIED Heimeshoff, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Hofmann, Steffen UNSPECIFIED UNSPECIFIED UNSPECIFIED Holzhey, David UNSPECIFIED orcid.org/0000-0002-0613-4419 UNSPECIFIED Oertel, Frank UNSPECIFIED UNSPECIFIED UNSPECIFIED Wahlers, Thorsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Kurucova, Jana UNSPECIFIED UNSPECIFIED UNSPECIFIED Thoenes, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Deutsch, Cornelia UNSPECIFIED UNSPECIFIED UNSPECIFIED Bramlage, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Schroefel, Holger UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-191427
DOI:	10.1093/ejcts/ezx397
Journal or Publication Title:	Eur. J. Cardio-Thorac. Surg.
Volume:	53
Number:	4
Page Range:	S. 771 - 778
Date:	2018
Publisher:	OXFORD UNIV PRESS INC
Place of Publication:	CARY
ISSN:	1873-734X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PRE-DILATION; FEASIBILITY; EXPERIENCE Multiple languages Cardiac & Cardiovascular Systems; Respiratory System; Surgery Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/19142