Evidence map›Paper›PMID 31451915›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2020

Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience.

Steffen D Kriechbaum, Niklas F Boeder, Luise Gaede, Martin Arnold, Ursula Vigelius-Rauch, Peter Roth, Michael Sander, Andreas Böning, Matthias Bayer, Albrecht Elsässer and 3 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device.Clinical research in cardiology : official journal of the German Cardiac Society · 2021
    Article
  7. Review
  8. 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

13 authors.

Steffen D KriechbaumDepartment of Cardiology and Angiology, Medical Clinic I, Universitätsklinikum Gießen and Marburg, University of Giessen, Klinikstraße 33, 35392, Giessen, Germany. steffen.kriechbaum@uk-gm.de.
Niklas F BoederDepartment of Cardiology and Angiology, Medical Clinic I, Universitätsklinikum Gießen and Marburg, University of Giessen, Klinikstraße 33, 35392, Giessen, Germany.
Luise GaedeMedical Clinic 2, University Hospital of Erlangen, Giessen, Germany.
Martin ArnoldMedical Clinic 2, University Hospital of Erlangen, Giessen, Germany.
Ursula Vigelius-RauchDepartment of Anaesthesiology, University of Giessen, Giessen, Germany.
Peter RothDepartment of Adult and Paediatric Cardiovascular Surgery, University of Giessen, Giessen, Germany.
Michael SanderDepartment of Anaesthesiology, University of Giessen, Giessen, Germany.
Andreas BöningDepartment of Adult and Paediatric Cardiovascular Surgery, University of Giessen, Giessen, Germany.
Matthias BayerDepartment of Cardiology and Angiology, Medical Clinic I, Universitätsklinikum Gießen and Marburg, University of Giessen, Klinikstraße 33, 35392, Giessen, Germany.
Albrecht ElsässerDepartment of Cardiology, University of Oldenburg, Oldenburg, Germany.
Helge MöllmannMedical Clinic I, Department of Cardiology, St-Johannes-Hospital, Dortmund, Germany.
Christian W HammDepartment of Cardiology and Angiology, Medical Clinic I, Universitätsklinikum Gießen and Marburg, University of Giessen, Klinikstraße 33, 35392, Giessen, Germany.
Holger M NefDepartment of Cardiology and Angiology, Medical Clinic I, Universitätsklinikum Gießen and Marburg, University of Giessen, Klinikstraße 33, 35392, Giessen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo examine the clinical experience and practical use of the PASCAL transcatheter valve repair system (Edwards Lifesciences, Irvine, CA, USA) and to report some of the first clinical results. METHODS AND

resultsA total of 18 consecutive patients with severe, symptomatic mitral regurgitation (MR) were included in this German multicentre registry. All patients underwent clinical, echocardiographic, and laboratory assessment prior to the PASCAL procedure and before hospital discharge. MR was classified as functional in 6 patients, degenerative in 2, and combined in 10. All except one received a single PASCAL implant. The preprocedural severe MR present in all patients was reduced: grade 0 in 4 (22.2%), grade I in 11 (61.1%), grade II in 3 (16.7%). The v-wave was significantly reduced from 31.7 ± 9.5 to 18 ± 7.7 mmHg (p < 0.001). Independent leaflet capture, performed in 4 (22.2%) of the patients, wide clasps, and the 10-mm central spacer are features of the PASCAL device to optimize mitral leaflet repair. There were no periprocedural complications.

conclusionPASCAL is a safe and effective mitral valve repair device for the treatment of severe MR. Device-specific features allow valve repair tailored to the individual anatomy of the underlying mitral pathology in each patient.

Indexed as

Cardiac CathetersAgedAged, 80 and overCardiac CatheterizationCohort StudiesEquipment DesignFemaleGermanyHeart Valve Prosthesis ImplantationHumansMaleMitral Valve InsufficiencyRegistriesTreatment OutcomeLeaflet repairMitral regurgitationMitral valve diseaseMitral valve repair

Identifiers

PMID31451915

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.