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Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry.

Abstract：

OBJECTIVES:Transaortic (TAo) access for transcatheter aortic valve implantation (TAVI) is an alternative to the conventional transfemoral or transapical routes. Data comparing the characteristics and outcomes of TAo-TAVI using the SAPIEN XT and SAPIEN 3 heart valves are scarce. The objective of the current analysis was to provide such information. METHODS:ROUTE is an international, prospective, observational registry. Patients with severe calcific aortic stenosis scheduled for TAo-TAVI with an Edwards SAPIEN XT or a SAPIEN 3 heart valve were consecutively enrolled at 22 centres across Europe between February 2013 and February 2015. Periprocedural, in-hospital and 30-day complication rates were assessed. RESULTS:Of the 301 patients included, 126 (41.9%) received a SAPIEN 3 and 175 (58.1%) a SAPIEN XT. The SAPIEN 3 was associated with shorter procedure time (101 ± 35 vs 111 ± 40 min; P = 0.031) and a lower quantity of contrast agent used (87 ± 43 vs 112 ± 50 ml; P < 0.001). Balloon dilation was performed less often before (68.0% vs 78.3%; P = 0.045) and after implantation (13.6% vs 30.1%; P = 0.001). No statistically significant differences between the valve types were documented for overall (4.1% SAPIEN 3 vs 7.6% SAPIEN XT; P = 0.21), TAVI-related (0.8% vs 4.7%; P = 0.084) and cardiovascular mortality (2.4% vs 5.9%; P = 0.158). Major vascular complications were less frequent (0.8% vs 5.3%; P = 0.049), and there was a lower rate of moderate-to-severe paravalvular regurgitation (0.8% vs 5.1%; P = 0.050) in the SAPIEN 3 group. CONCLUSIONS:Both the SAPIEN XT and SAPIEN 3 were safely implanted via the TAo route, though the SAPIEN 3 may be associated with a higher procedural success rate and improved prognosis. ClinicalTrials.gov Identifier:NCT01991431.

journal_name

Interact Cardiovasc Thorac Surg

journal_title

Interactive cardiovascular and thoracic surgery

authors

Romano M,Frank D,Cocchieri R,Jagielak D,Bonaros N,Aiello M,Lapeze J,Laine M,Chocron S,Muir D,Eichinger W,Thielmann M,Labrousse L,Arne Rein K,Verhoye JP,Gerosa G,Baumbach H,Deutsch C,Bramlage P,Thoenes M,Bapat V

doi

10.1093/icvts/ivx159

subject

Has Abstract

pub_date

2017-11-01 00:00:00

pages

757-764

issue

eissn

1569-9293

issn

1569-9285

pii

3861509

journal_volume

pub_type

杂志文章,多中心研究

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Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry.