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Rigshospitalet - a part of Copenhagen University Hospital
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Thirty-day clinical outcomes of the Evolut PRO self-expanding transcatheter aortic valve: the international FORWARD PRO study

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  • Ganesh Manoharan
  • Eberhard Grube
  • Nicolas M Van Mieghem
  • Stephen Brecker
  • Claudia Fiorina
  • Ran Kornowski
  • Haim Danenberg
  • Hendrik Ruge
  • Holger Thiele
  • Patrizio Lancellotti
  • Lars Søndergaard
  • Corrado Tamburino
  • Jae K Oh
  • Yunhua Fan
  • Stephan Windecker
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AIMS: The Evolut PRO is a new transcatheter heart valve with an outer pericardial wrap intended to reduce paravalvular leak and facilitate tissue ingrowth. We aimed to evaluate the clinical performance and safety of the Evolut PRO valve in standard practice.

METHODS AND RESULTS: FORWARD PRO is a prospective, multinational, multicentre observational study. Transcatheter aortic valve implantation with the Evolut PRO valve (23, 26, or 29 mm) was attempted in 629 non-consecutive patients from 39 centres from February 2018 to January 2019. The primary endpoint was the rate of all-cause mortality at 30 days compared to a pre-specified performance goal. An independent clinical events committee adjudicated safety endpoints based on VARC-2 definitions. All echocardiograms were centrally assessed by an independent core laboratory (Mayo Clinic, Rochester, MN, USA). Baseline characteristics included mean age 81.7±6.1 years, 61.8% female, STS score 4.7±3.3%, and 33.6% were frail. All-cause mortality at 30 days was 3.2%, which was lower than the pre-specified performance goal of 5.5% (p=0.004). Greater than mild AR was present in 1.8% of patients at discharge.

CONCLUSIONS: The FORWARD PRO study confirmed the safety and efficacy of the Evolut PRO transcatheter aortic valve system with an external pericardial wrap. ClinicalTrials.gov Identifier: NCT03417011 Visual summary. Paravalvular leak at discharge and (right) the Evolut PRO valve (Medtronic) with external pericardial wrap. Reproduced with permission from Medtronic, Inc.

Original languageEnglish
JournalEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Volume16
Issue number10
Pages (from-to)850-857
Number of pages8
ISSN1774-024X
DOIs
Publication statusPublished - 20 Nov 2020

    Research areas

  • Aged, Aged, 80 and over, Aortic Valve/diagnostic imaging, Aortic Valve Stenosis/diagnostic imaging, Female, Heart Valve Prosthesis, Humans, Male, Postoperative Complications, Prospective Studies, Prosthesis Design, Transcatheter Aortic Valve Replacement/adverse effects, Treatment Outcome

ID: 62241392