Evidence map›Paper›PMID 33103545›Full record

ArticleJournal of the American Heart Association2020

Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry.

Sergio Berti, Francesco Bedogni, Arturo Giordano, Anna S Petronio, Alessandro Iadanza, Antonio L Bartorelli, Bernard Reimers, Carmen Spaccarotella, Carlo Trani, Tiziana Attisano and 8 more

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter Study
In one paragraph

Article in Journal of the American Heart Association, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07554976 (Prospective, Multicenter, Randomized Controlled Study to Evaluate the Efficacy and Safety of a Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures), which is not on this map. Cited by 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
5.1field-weighted citation impact, top 3% of its field
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.

NCT07554976 narecruitingnot on this mapstarted 2025, after this paper: background citation

Prospective, Multicenter, Randomized Controlled Study to Evaluate the Efficacy and Safety of a Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures

TypeinterventionalSponsorSuzhou Hengruihongyuan Medical Technology Co. LTDRan2025 to 2026Enrolled136ConditionsPercutaneous Intervention Via Common Femoral VeinArmsSPIDER, Perclose ProGlide
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Pooled it
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  13. Dual ProGlide versus ProGlide and FemoSeal for vascular access haemostasis after transcatheter aortic valve implantation.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022
    Article
  14. Handling high-risk patients in the catheterization laboratory.European heart journal supplements : journal of the European Society of Cardiology · 2022
    Article
  15. Article
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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

18 authors at 16 institutions in 3 countries.

Sergio BertiDepartment of Diagnostic and Interventional Cardiology Gabriele Monasterio Tuscany Foundation, G. Pasquinucci Heart Hospital Massa Italy.
Francesco BedogniDepartment of Clinical and Interventional Cardiology IRCCS Policlinico San Donato Milan Italy.
Arturo GiordanoUnità Operativa di Interventistica Cardiovascolare Pineta Grande Hospital Castel Volturno Italy.
Anna S PetronioDepartment of Cardiology Azienda Ospedaliero-Universitaria Pisana Pisa Italy.
Alessandro IadanzaAzienda Ospedaliera Universitaria Senese, Policlinico Le Scotte Siena Italy.
Antonio L BartorelliCentro Monzino IRCCS and Department of Biomedical and Clinical Sciences "Luigi Sacco" University of Milan Italy.
Bernard ReimersCardio Center Humanitas Research Hospital IRCCS Rozzano-Milan Italy.
Carmen SpaccarotellaDivision of Cardiology CCU and Interventional Cardiology Cardiovascular Research Center University Magna Graecia Catanzaro Italy.
Carlo TraniInstitute of Cardiology Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore Rome Italy.
Tiziana AttisanoCardiologia Interventistica Dipartimento Cardio Toraco Vascolare AOU S. Giovanni di Dio e Ruggi D'Aragona Salerno Italt.
Angela Marella CennameFondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore Rome Italy.
Gennaro SardellaDepartment of Cardiology Policlinico "Umberto I" Sapienza University of Rome Italy.
Roberto BonmassariDepartment of Cardiology S. Chiara Hospital Trento Italy.
Massimo MeddaIstituto Clinico Sant'Ambrogio, Gruppo San Donato Milano Italy.
Fabrizio TomaiDivision of Cardiology European Hospital Rome Italy.
Giuseppe TarantiniA.O. Policlinico Universitario di Padova, Centro Gallucci Padova Italy.
Eliano P NavareseDepartment of Cardiology and Internal Medicine Interventional Cardiology and Cardiovascular Medicine Research Nicolaus Copernicus University Bydgoszcz Poland.
Italian Society of Interventional Cardiology‐GISE†
Università Cattolica del Sacro Cuore · ITAzienda Ospedaliera Universitaria Pisana · ITAzienda Ospedaliera Universitaria Senese · ITEuropean Hospital · ITFondazione Toscana Gabriele Monasterio · ITIRCCS Humanitas Research Hospital · ITIRCCS Policlinico San Donato · ITIstituto Clinico Sant'Ambrogio · ITMagna Graecia University · ITOspedale Santa Chiara · ITOspedali Riuniti San Giovanni di Dio e Ruggi d'Aragona · ITPoliclinico Umberto I · ITPoliclinico Universitario di Catania · ITUniversity of Alberta · CAUniversity of Milan · ITVilla Pineta Hospital · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Transcatheter aortic valve replacement (TAVR) requires large-bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large-scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1-year follow-up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 [95% CI, 0.65-0.99];

Indexed as

Vascular Closure DevicesAgedAged, 80 and overAortic Valve StenosisCohort StudiesFemaleHemostatic TechniquesHumansLength of StayMalePostoperative HemorrhageRegistriesTranscatheter Aortic Valve ReplacementTreatment OutcomeProGlideProstartranscatheter aortic valve replacementvascular closure devices

Identifiers

PMID33103545
PMCPMC7763424
OpenAlexW3093709101

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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.