Evidence map›Paper›PMID 39686582›Full record

ArticleCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2025

Three-Year Outcomes With a Supra-Annular, Self-Expanding Bioprosthesis and a Pericardial Wrap-The FORWARD PRO Study.

Nicolas M Van Mieghem, Stephan Windecker, Ganesh Manoharan, Patrizio Lancellotti, Corrado Tamburino, Ran Kornowski, Holger Thiele, Haim Danenberg, Claudia Fiorina, Werner Scholtz and 12 more

Abstract readMulticenter Study
In one paragraph

Article in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Nicolas M Van MieghemDepartment of Cardiology, Cardiovascular Institute, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands.ORCID 0000-0002-2732-1205
Stephan WindeckerDepartment of Cardiology, Inselspital, Bern University Hospital, Bern, Switzerland.
Ganesh ManoharanDepartment of Cardiology, Regional Health Centre, Royal Victoria Hospital, Belfast, UK.
Patrizio LancellottiCardiology Department, University Hospital of Liege, Liege, Belgium.
Corrado TamburinoCardiothoracic, Transplantation and Vascular Surgery Department, Azienda Policlinico-Vittorio Emanuele, Universita di Catania, Catania, Italy.
Ran KornowskiCardiology Division, Rabin Medical Center, Petach Tikva, Israel.ORCID 0000-0002-7708-8253
Holger ThieleDepartment of Internal Medicine, Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.
Haim DanenbergInterventional Cardiology, Wolfson Medical Center, Tel Aviv, Israel.
Claudia FiorinaCardiothoracic Department, Spedali Civili di Brescia, Brescia, Italy.
Werner ScholtzClinic for General and Interventional Cardiology, Angiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Universitätsklinik der Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
Stephen BreckerDepartment of Cardiology, Saint George's Hospital, London, UK.
Hendrik RugeDepartment of Cardiovascular Surgery, Deutsches Herzzentrum München, Munich, Germany.
Anders OpdahlDepartment of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Giovanni AmorosoDepartment of Cardiology, OLVG, Amsterdam, The Netherlands.
Francesco BedogniClinical Cardiology, Inverventional Cardiology and Coronary Intesive Care Units, IRCCS Policlinico San Donato, Milan, Italy.ORCID 0000-0002-4975-6605
Anna Sonia PetronioCardioThoracic and Vascular Department, University Hospital, Pisa, Italy.
Georg NickenigHeart Center Bonn, University Hospital Bonn, Bonn, Germany.
Axel HarnathCardiology Department, Sana Heart Center, Cottbus, Germany.
Joerg KempfertDepartment of Cardiothoracic and Vascular Surgery, German Heart Institute Charité Berlin, Berlin, Germany.
Jae K OhEchocardiography Core Laboratory, Mayo Clinic, Rochester, Minnesota, USA.
Ruth E EisenbergStructural Heart and Aortic, Medtronic, Minneapolis, Minnesota, USA.
Eberhard GrubeCenter of Innovative Interventions in Cardiology, University Hospital Bonn, Bonn, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe self-expanding, supra-annular Evolut valve is an established platform for Transcatheter Aortic Valve Implantation (TAVI). Evolut PRO introduced an outer sealing wrap to mitigate paravalvular leakage. We evaluated the 3-year clinical outcomes and valve performance of the Evolut PRO in standard clinical practice for severe aortic stenosis (AS) patients at intermediate or higher risk for surgery.

methodsThe FORWARD PRO prospective, single-arm, multicentre, post-market clinical study enrolled 638 patients with native aortic valve stenosis or failed surgical bioprosthetic aortic valve undergoing TAVI, at intermediate or high risk, with the Evolut PRO valve. Clinical and serial echocardiographic outcomes were followed-up for 3 years.

resultsTAVI using Evolut PRO was attempted in 629 AS patients (implanted in 97%) (mean age 81.7 years; STS PROM score, 4.7%). At 3 years all-cause mortality was 25.0%, disabling stroke 6.5% (all-cause mortality or disabling stroke, 28.5%) and rate of new permanent pacemaker implantation 24.7%. Excellent valve haemodynamics were maintained (mean gradient 8.8 ± 4.7 mm Hg; mean effective orifice area 2.0 ± 0.5 cm

conclusionsIn clinical practice TAVI with the Evolut PRO valve is associated with favorable clinical outcomes and excellent haemodynamic performance out to 3 years. The observation of improvements in PVL over time warrants further research.

Indexed as

Aortic ValveAortic Valve StenosisBioprosthesisHeart Valve ProsthesisPericardiumTranscatheter Aortic Valve ReplacementAgedAged, 80 and overFemaleHemodynamicsHumansMaleProspective StudiesProsthesis DesignRecovery of FunctionRisk Factorsaortic valve stenosisparavalvular leakpericardial wraptranscatheter aortic valve implantationtranscatheter aortic valve replacement

Identifiers

PMID39686582
PMCPMC11831722

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.