Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial

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Abstract

Background

Balloon 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/design

The 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.

Discussion

This 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 registration

ClinicalTrials.gov identifier: NCT02729519. Registered on 15 July 2016.

Electronic supplementary material

The online version of this article (doi:10.1186/s13063-017-2036-y) contains supplementary material, which is available to authorized users.

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Most cited references 18

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Registry of Transcatheter Aortic-Valve Implantation in High-Risk Patients

Martine Gilard, Hélène Eltchaninoff, Bernard Iung … (2012)

Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2. All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause. A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival. This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).

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Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

Philippe Genereux, Ajay Kirtane, Martin Leon … (2012)

The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. Two in-person meetings (held in September 2011 in Washington, DC, and in February 2012 in Rotterdam, The Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and noninterventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints. This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavors of applying definitions to other transcatheter valve therapies (for example, mitral valve repair). Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

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Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience.

Josep Rodès-Cabau, John G Webb, Anson Cheung … (2010)

The aim of this study was: 1) to evaluate the acute and late outcomes of a transcatheter aortic valve implantation (TAVI) program including both the transfemoral (TF) and transapical (TA) approaches; and 2) to determine the results of TAVI in patients deemed inoperable because of either porcelain aorta or frailty. Very few data exist on the results of a comprehensive TAVI program including both TA and TF approaches for the treatment of severe aortic stenosis in patients at very high or prohibitive surgical risk. Consecutive patients who underwent TAVI with the Edwards valve (Edwards Lifesciences, Inc., Irvine, California) between January 2005 and June 2009 in 6 Canadian centers were included. A total of 345 procedures (TF: 168, TA: 177) were performed in 339 patients. The predicted surgical mortality (Society of Thoracic Surgeons risk score) was 9.8 +/- 6.4%. The procedural success rate was 93.3%, and 30-day mortality was 10.4% (TF: 9.5%, TA: 11.3%). After a median follow-up of 8 months (25th to 75th interquartile range: 3 to 14 months) the mortality rate was 22.1%. The predictors of cumulative late mortality were peri-procedural sepsis (hazard ratio [HR]: 3.49, 95% confidence interval [CI]: 1.48 to 8.28) or need for hemodynamic support (HR: 2.58, 95% CI: 1.11 to 6), pulmonary hypertension (PH) (HR: 1.88, 95% CI: 1.17 to 3), chronic kidney disease (CKD) (HR: 2.30, 95% CI: 1.38 to 3.84), and chronic obstructive pulmonary disease (COPD) (HR: 1.75, 95% CI: 1.09 to 2.83). Patients with either porcelain aorta (18%) or frailty (25%) exhibited acute outcomes similar to the rest of the study population, and porcelain aorta patients tended to have a better survival rate at 1-year follow-up. A TAVI program including both TF and TA approaches was associated with comparable mortality as predicted by surgical risk calculators for the treatment of patients at very high or prohibitive surgical risk, including porcelain aorta and frail patients. Baseline (PH, COPD, CKD) and peri-procedural (hemodynamic support, sepsis) factors but not the approach determined worse outcomes. Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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Author and article information

Contributors

Florence Leclercq:

ORCID: http://orcid.org/0000-0001-5936-5184

+ (33)467336188 , f-leclercq@chu-montpellier.fr

Pierre Robert: pierretuto@gmail.com

Jessica Labour: labour.jessica@gmail.com

Benoit Lattuca: benoit.lattuca@gmail.com

Mariama Akodad: akodadmyriam@gmail.com

Jean-Christophe Macia: jc-macia@chu-montpellier.fr

Richard Gervasoni: r-gervasoni@chu-montpellier.fr

Francois Roubille: francois.roubille@gmail.com

Thomas Gandet: t-gandet@chu-montpellier.fr

Laurent Schmutz: laurent.schmutz@chu-nimes.fr

Erika Nogue: e-nogue@chu-montpellier.fr

Nicolas Nagot: n-nagot@chu-montpellier.fr

Bernard Albat: b-albat@chu-montpellier.fr

Guillaume Cayla: cayla.guillaume@gmail.com

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 4 July 2017

Publication date PMC-release: 4 July 2017

Publication date Collection: 2017

Volume: 18

Electronic Location Identifier: 303

Affiliations

[1 ]ISNI 0000 0000 9961 060X, GRID grid.157868.5, Department of Cardiology, , University Hospital of Montpellier, ; Montpellier, France

[2 ]ISNI 0000 0000 9961 060X, GRID grid.157868.5, Department of Cardiovascular Surgery, , University Hospital of Montpellier, ; Montpellier, France

[3 ]ISNI 0000 0004 0593 8241, GRID grid.411165.6, Department of Cardiology, , University Hospital of Nimes, ; Nimes, France

[4 ]ISNI 0000 0000 9961 060X, GRID grid.157868.5, Department of Medical Information, , University Hospital of Montpellier, ; Montpellier, France

[5 ]ISNI 0000 0001 2097 0141, GRID grid.121334.6, Department of Cardiology, Arnaud de Villeneuve Hospital, , University of Montpellier, ; Avenue du doyen Giraud, 34295 Montpellier cedex 5, France

Author information

Florence Leclercq http://orcid.org/0000-0001-5936-5184

Article

Publisher ID: 2036

DOI: 10.1186/s13063-017-2036-y

PMC ID: 5496363

SO-VID: 2cdd4516-078e-45cf-8537-20e1db1188cb

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 18 October 2016

Date accepted : 1 June 2017

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100006520, Edwards Lifesciences;

Award ID: 80100 EUROS

Award Recipient : Florence Leclercq

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: transcatheter aortic valve implantation (tavi),balloon aortic valvuloplasty,procedural success,safety,randomized clinical trial

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ScienceOpen disciplines: Medicine

Keywords: transcatheter aortic valve implantation (tavi), balloon aortic valvuloplasty, procedural success, safety, randomized clinical trial

Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial

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Abstract

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Trial registration

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Herbal Medicines Journal (Herb Med J)

Most cited references 18

Registry of Transcatheter Aortic-Valve Implantation in High-Risk Patients

Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience.

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