Evidence map›Paper›PMID 40070322›Full record

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

Prospective Analysis of the Feasibility of the PASCAL System for Transcatheter Mitral Valve Repair (OneForAll-Registry).

Katharina Hellhammer, Florian Schindhelm, Matthias Riebisch, Rolf Alexander Janosi, Alexander Y Lind, Matthias Totzeck, Peter Luedike, Tienush Rassaf, Amir Abbas Mahabadi

Abstract readObservational Study
In one paragraph

Observational study 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Interventional Mitral Valve Edge-to-Edge Repair in Patients Above 85 Years of Age.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026
    Article
  2. Article
  3. 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

9 authors.

Katharina HellhammerWest German Heart and Vascular Center, Department of Cardiology and Vascular Medicine, University Hospital Essen, Essen, Germany.
Florian SchindhelmWest German Heart and Vascular Center, Department of Cardiology and Vascular Medicine, University Hospital Essen, Essen, Germany.
Matthias RiebischWest German Heart and Vascular Center, Department of Cardiology and Vascular Medicine, University Hospital Essen, Essen, Germany.
Rolf Alexander JanosiWest German Heart and Vascular Center, Department of Cardiology and Vascular Medicine, University Hospital Essen, Essen, Germany.ORCID 0000-0002-9966-6886
Alexander Y LindWest German Heart and Vascular Center, Department of Cardiology and Vascular Medicine, University Hospital Essen, Essen, Germany.ORCID 0000-0001-9122-797X
Matthias TotzeckWest German Heart and Vascular Center, Department of Cardiology and Vascular Medicine, University Hospital Essen, Essen, Germany.
Peter LuedikeWest German Heart and Vascular Center, Department of Cardiology and Vascular Medicine, University Hospital Essen, Essen, Germany.
Tienush RassafWest German Heart and Vascular Center, Department of Cardiology and Vascular Medicine, University Hospital Essen, Essen, Germany.
Amir Abbas MahabadiWest German Heart and Vascular Center, Department of Cardiology and Vascular Medicine, University Hospital Essen, Essen, Germany.

Funding

The present study was funded by an institutional research grant from Edwards Lifesciences. This work was supported by Edwards Lifesciences Irvine, US-CA to PL.
6 · The paper itself

Abstract

backgroundMitral valve transcatheter edge-to-edge repair (M-TEER) is increasingly applied in patients with high surgical risk. We aimed to evaluate whether the PASCAL system can be applied in an all-comers cohort irrespective of the underlying anatomy and whether technical features influence therapeutic success.

methodsIn this prospective, observational study we enrolled consecutive patients (n = 80) with mitral regurgitation (MR) 3+ and 4+ scheduled for M-TEER. All patients were allocated to be treated with the PASCAL system irrespective of the underlying anatomy. Complexity of mitral valve anatomy was assessed according to the proposed complexity scale and the ESC/EACTS complexity scale. All patients underwent intraprocedural analysis of application of technical features of the PASCAL technology and 1-year follow-up.

resultsM-TEER was successful in 98.8% of the patients. Reduction of MR 3+/4+ to MR≤ 2+ was achieved in 92.5%. Independent leaflet grasping was applied in 60.0% of procedures. The median number of grasping attempts was 4.0 ± 3.1 for the first device. Classification in degenerative, functional, or mixed MR did not correlate with procedure time and grasping attempts. In contrast, the presence of complexity criteria was linked with a longer procedure time (p = 0.002) and required more grasping attempts (p = 0.010).

conclusionsM-TEER with the PASCAL technology was possible in 98.8% of consecutive, all-comers patients irrespective of the underlying anatomy. Technical features were applied frequently with increasing application in complex anatomical cases. Classifications taking the anatomical complexity into account rather than the pathophysiological entity of MR seem superior to predict the technical challenges of a M-TEER procedure.

Indexed as

Cardiac CatheterizationHeart Valve ProsthesisHeart Valve Prosthesis ImplantationMitral ValveMitral Valve InsufficiencyAgedAged, 80 and overFeasibility StudiesFemaleHumansMaleMiddle AgedProspective StudiesProsthesis DesignRecovery of FunctionRegistries

Identifiers

PMID40070322
PMCPMC12057317

What OpenQuestion holds

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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.