Evidence map›Paper›PMID 40781114›Full record

Observational studyScientific reports2025

Crossover balloon occlusion technique for access closure during transcatheter aortic valve implantation: a multicenter observational study.

Gianluigi Napoli, Arturo Ausiello, Vincenzo Pestrichella, Gianluigi Novielli, Rocco Tritto, Palma Luisa Nestola, Luigi My, Giuseppe Biondi-Zoccai, Nicola Corcione, Arturo Giordano and 3 more

Abstract readObservational StudyMulticenter Study
In one paragraph

Observational study in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

Gianluigi NapoliDivision of Cardiology, "Villa Verde" Clinic, Taranto, Italy.
Arturo AusielloDivision of Cardiology, "Villa Verde" Clinic, Taranto, Italy.
Vincenzo PestrichellaDivision of Cardiology, "Mater Dei" Hospital, Bari, Italy.
Gianluigi NovielliDivision of Cardiology, Department of Interdisciplinary Medicine (D.I.M.), University of Bari Aldo Moro, P.zza Giulio Cesare 11, Bari, 70124, Italy.
Rocco TrittoDivision of Cardiology, Department of Interdisciplinary Medicine (D.I.M.), University of Bari Aldo Moro, P.zza Giulio Cesare 11, Bari, 70124, Italy.
Palma Luisa NestolaDivision of Cardiology, "Mater Dei" Hospital, Bari, Italy.
Luigi MyDivision of Cardiology, "Villa Verde" Clinic, Taranto, Italy.
Giuseppe Biondi-ZoccaiDepartment of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.
Nicola CorcioneCardiovascular Interventions Unit, Pineta Grande Hospital, Castel Volturno, Italy.
Arturo GiordanoCardiovascular Interventions Unit, Pineta Grande Hospital, Castel Volturno, Italy.
Sabino IlicetoHeart Center Mater Dei Hospital, LUM University, Bari, Italy.
Marco Matteo CicconeDivision of Cardiology, Department of Interdisciplinary Medicine (D.I.M.), University of Bari Aldo Moro, P.zza Giulio Cesare 11, Bari, 70124, Italy.
Martino PepeDivision of Cardiology, Department of Interdisciplinary Medicine (D.I.M.), University of Bari Aldo Moro, P.zza Giulio Cesare 11, Bari, 70124, Italy. martino.pepe@uniba.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The ProGlide system represents the most common approach to close the main access site during transcatheter aortic valve implantation (TAVI). A crossover balloon occlusion technique (CBOT) has been reported in small case-series to possibly provide a controlled, safe, and successful hemostasis during TAVI. We sought to investigate the comparative performance of a combined (CBOT + ProGlide) compared with a ProGlide only approach. Primary endpoint was VARC-3 type ≥ 2 bleeding. Secondary outcomes included red blood cells transfusion, vascular complications, acute kidney injury (AKI), length of hospital stay (LOS), and death. Our study retrospectively included 229 consecutive patients admitted to "Villa Verde" Clinic (Taranto, Italy) and "Mater Dei" Hospital (Bari, Italy) and treated with TAVI. The study population was divided based on the access closure strategy in two groups: the combined and the ProGlide suture only group. The CBOT + ProGlide treated group presented lower incidence of primary endpoint, as well as less red blood cells transfusions, AKI stages ≥ 2, and shorter LOS. After propensity-score matching, the CBOT + ProGlide group confirmed lower incidence of primary endpoint (2 (2.4%) vs. 10 (11.9%), p = 0.016), of AKI stage ≥ 2 (0 vs. 5 (6%), p = 0.029), and shorter LOS (6.9 ± 4.0 vs. 8.9 ± 6.1, p = 0.015); moreover, the multivariate logistic regression analysis confirmed the protective role of the combined approach against VARC-3 type ≥ 2 bleeding (CI 0.04-0.99; OR 0.2; p = 0.05). Data from this multicenter comparative study highlight that a routinary percutaneous closure of the main TAVI access with ProGlide coupled with CBOT is possible and safe. Moreover, this combined approach seems promising in terms of reduced bleeding, RBC transfusions, AKI incidence, and shortening of hospitalizations.

Indexed as

Balloon OcclusionTranscatheter Aortic Valve ReplacementAcute Kidney InjuryAgedAged, 80 and overFemaleHemorrhageHumansLength of StayMaleRetrospective StudiesTreatment OutcomeBalloonBleedingEndoclampProGlideTAVI

Identifiers

PMID40781114
PMCPMC12334572

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.