Ganesh Manoharan1, MBBCh, MD; Eberhard Grube2, MD, PhD; Nicolas M. Van Mieghem3, MD, PhD; Stephen Brecker4, MD; Claudia Fiorina5, MD; Ran Kornowski6, MD; Haim Danenberg7, MD; Hendrik Ruge8, MD; Holger Thiele9, MD; Patrizio Lancellotti10, MD, PhD; Lars Søndergaard11, MD, PhD; Corrado Tamburino12, MD, PhD; Jae K. Oh13, MD; Yunhua Fan14, MS; Stephan Windecker15, MD
1. Regional Cardiology Department, Royal Victoria Hospital, Belfast, United Kingdom; 2. Department of Medicine, University of Bonn, Bonn, Germany; 3. Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands; 4. Cardiology Clinical Academic Group, Saint George's Hospital, London, United Kingdom; 5. Cardiothoracic Department, Spedali Civili Hospital of Brescia, Brescia, Italy; 6. Department of Cardiology, Rabin Medical Center – Beilinson Hospital, Petah Tikva, Israel; 7. Department of Interventional Cardiology, Hadassah Medical Organization, Jerusalem, Israel; 8. Department of Cardiovascular Surgery, German Heart Center Munich at the Technical University of Munich, Munich, Germany; 9. Department of Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany; 10. Department of Cardiology, University of Liege Hospital, GIGA Cardiovascular Sciences, CHU Sart Tilman, Liège, Belgium; 11. Department of Cardiology, Rigshospitalet, Copenhagen, Denmark; 12. Department of Cardiology, Gaspare Rodolico Hospital, Catania, Italy; 13. Department of Cardiology, Mayo Clinic, Rochester, MN, USA; 14. Department of Statistics, Medtronic, Minneapolis, MN, USA; 15. Department of Cardiology, University Hospital Bern, Bern, Switzerland
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.