Abstract
BackgroundBalloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation.Methods/designThe transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that includes 240 patients randomized to TAVI performed with prior balloon valvuloplasty (control arm) or direct implantation of the valve (test arm). All patients with an indication for TAVI will be included excepting those requiring transapical access. The trial tests the hypothesis that the strategy of direct implantation of the new-generation balloon-expandable SAPIEN 3 valve is noninferior to current medical practice using predilatation of the valve. The primary endpoint assessing efficacy and safety of the procedure consists of immediate procedural success and secondary endpoints include complications at 30-day follow-up (VARC-2 criteria). A subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and between 1 and 3 days after the procedure.DiscussionThis prospective randomized study is designed to assess the efficacy and safety of TAVI performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves. We aim to provide robust evidence of the advantages of this strategy to allow the interventional cardiologist to use it in everyday practice.Trial registrationClinicalTrials.gov identifier: NCT02729519. Registered on 15 July 2016.
Highlights
Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure
This prospective randomized study is designed to assess the efficacy and safety of Transcatheter aortic valve implantation (TAVI) performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves
Few nonrandomized studies have shown that direct implantation of the transcatheter heart valve (THV) is feasible [10, 13, 14], but there are currently no randomized data concerning the safety and efficacy of TAVI performed with new-generation balloonexpandable THVs without prior dilatation of the aortic valve
Summary
Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. Balloon aortic valvuloplasty (BAV) has been considered as a mandatory step in the TAVI procedure both to facilitate the implantation of the transcatheter heart valve (THV) and to reduce the radial counterforce for optimal device expansion. With the development of a new generation of balloon-expandable THVs, associated with low profile and orientable delivery system, the crossing of the valve is facilitated. While both balloon dilatation and the need for post dilatation have been considered to increase the risk of cerebral embolization, avoiding BAV prior to TAVI is attractive and may simplify the procedure [9,10,11,12]. Few nonrandomized studies have shown that direct implantation of the THV is feasible [10, 13, 14], but there are currently no randomized data concerning the safety and efficacy of TAVI performed with new-generation balloonexpandable THVs without prior dilatation of the aortic valve
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