Evidence map›Paper›PMID 34448541›Full record

ArticleESC heart failure2021

PASCAL-based mitral valve repair in an all-comer population: acute and mid-term clinical results.

Philipp Schlegel, Patricia Crespo López, Michael M Kreusser, Hugo A Katus, Norbert Frey, Nicolas A Geis, Philip W J Raake

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in ESC heart failure, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 26% 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.

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

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
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

7 authors at 1 institution in 1 country.

Philipp SchlegelDepartment of Internal Medicine III, Cardiology, University Hospital Heidelberg, University of Heidelberg, Im Neuenheimer Feld 410, Heidelberg, 69120, Germany.ORCID 0000-0003-3888-6655
Patricia Crespo LópezDepartment of Internal Medicine III, Cardiology, University Hospital Heidelberg, University of Heidelberg, Im Neuenheimer Feld 410, Heidelberg, 69120, Germany.
Michael M KreusserDepartment of Internal Medicine III, Cardiology, University Hospital Heidelberg, University of Heidelberg, Im Neuenheimer Feld 410, Heidelberg, 69120, Germany.
Hugo A KatusDepartment of Internal Medicine III, Cardiology, University Hospital Heidelberg, University of Heidelberg, Im Neuenheimer Feld 410, Heidelberg, 69120, Germany.
Norbert FreyDepartment of Internal Medicine III, Cardiology, University Hospital Heidelberg, University of Heidelberg, Im Neuenheimer Feld 410, Heidelberg, 69120, Germany.
Nicolas A GeisDepartment of Internal Medicine III, Cardiology, University Hospital Heidelberg, University of Heidelberg, Im Neuenheimer Feld 410, Heidelberg, 69120, Germany.
Philip W J RaakeDepartment of Internal Medicine III, Cardiology, University Hospital Heidelberg, University of Heidelberg, Im Neuenheimer Feld 410, Heidelberg, 69120, Germany.
Heidelberg University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsWe investigated short and mid-term safety and efficacy of the PASCAL system for percutaneous mitral valve repair (PMVr) in severe mitral regurgitation (MR) in an all-comer population. METHODS AND

resultsIn the first consecutive 41 patients undergoing PMVr using the PASCAL system in our centre, procedural success and safety were assessed. Efficacy in improving MR and functional class were evaluated. Median patient age was 74 years, 58.5% were male patients, and median European System for Cardiac Operative Risk Evaluation Score II was 5.1%. All patients suffered from severe MR with 59% functional MR, 29% degenerative MR, and 12% of mixed aetiology MR. The technical success rate was 90%, limited by four cases where PASCAL implantation was aborted due to a prohibitive mitral gradient. On average, 1.16 PASCAL devices per patient were implanted. All patients successfully implanted with a PASCAL device were discharged with MR grade ≤ 2 and 79% with MR grade ≤ 1. Mean follow-up was 8.7 ± 4.9 months. Ninety-seven per cent of patients remained at MR ≤ 2 at follow-up, which translated into a significantly improved New York Heart Association functional class as well as a significant reduction of systolic pulmonary artery pressure and brain natriuretic peptide levels. The procedure-related rate for major adverse events was 3%. Neither early nor late single-leaflet detachment was found. In one patient, air embolism occurred, resulting in modification of the PASCAL instructions for use.

conclusionsPercutaneous mitral valve repair using PASCAL in a real-world, all-comer population was feasible and safe, resulting in a significant mid-term reduction of MR with persistent clinical improvement.

Indexed as

Cardiac Surgical ProceduresHeart Valve Prosthesis ImplantationMitral Valve InsufficiencyAgedHumansMaleMitral ValveTreatment OutcomeEdge-to-edge repairHeart failureLeaflet repairMitral valve regurgitationMitral valve repairPASCAL device

Identifiers

PMID34448541
PMCPMC8497336
OpenAlexW3195636951

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.