Evidence map›Paper›PMID 30879050›Full record

Observational studyEuropean journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery2019

A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry data†.

Dietmar Boethig, Alexander Horke, Mark Hazekamp, Bart Meyns, Filip Rega, Joeri Van Puyvelde, Michael Hübler, Martin Schmiady, Anatol Ciubotaru, Giovanni Stellin and 8 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02035540 (European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR), which is not on this map. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 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.

NCT02035540 completednot on this map

European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR

TypeobservationalSponsorcorlifeRan2014 to 2017Enrolled121ConditionsHeart Valve DiseaseArmsDecellularized human valves
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  16. 5-Year results from the prospective European multi-centre study on decellularized homografts for pulmonary valve replacement ESPOIR Trial and ESPOIR Registry data.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2022
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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.

Dietmar BoethigDepartment of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Alexander HorkeDepartment of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Mark HazekampDepartment of Congenital Cardiac Surgery, Leiden University Medical Center, Leiden, Netherlands.
Bart MeynsDepartment of Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium.
Filip RegaDepartment of Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium.
Joeri Van PuyveldeDepartment of Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium.
Michael HüblerDivision of Congenital Cardiovascular Surgery, University Children's Hospital, Zurich, Switzerland.
Martin SchmiadyDivision of Congenital Cardiovascular Surgery, University Children's Hospital, Zurich, Switzerland.
Anatol CiubotaruCardiac Surgery Center, State Medical and Pharmaceutical University, Chisinau, Moldova.
Giovanni StellinPediatric and Congenital Cardiac Surgery Unit, Azienda Ospedaliera di Padova, University of Padua Medical School, Padova, Italy.
Massimo PadalinoPediatric and Congenital Cardiac Surgery Unit, Azienda Ospedaliera di Padova, University of Padua Medical School, Padova, Italy.
Viktor TsangDepartment of Cardiothoracic Surgery, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.
Ramadan JashariEuropean Homograft Bank, Clinique Saint-Jean, Bruessels, Belgium.
Dmitry BobylevDepartment of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Igor TudoracheDepartment of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Serghei CebotariDepartment of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Axel HaverichDepartment of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Samir SarikouchDepartment of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesDecellularized pulmonary homografts (DPH) have shown excellent results for pulmonary valve replacement. However, controlled multicentre studies are lacking to date.

methodsProspective European multicentre trial evaluating DPH for pulmonary valve replacement. Matched comparison of DPH to bovine jugular vein (BJV) conduits and cryopreserved homografts (CH) considering patient age, type of heart defect and previous procedures.

resultsIn total, 121 patients (59 female) were prospectively enrolled (August 2014-December 2016), age 21.3 ± 14.4 years, DPH diameter 24.4 ± 2.8 mm. No adverse events occurred with respect to surgical handling; there were 2 early deaths (30 + 59 years) due to myocardial failure after multi-valve procedures and no late mortality (1.7% mortality). After a mean follow-up of 2.2 ± 0.6 years, the primary efficacy end points mean peak gradient (16.1 ± 12.1 mmHg) and regurgitation (mean 0.25 ± 0.48, grade 0-3) were excellent. One reoperation was required for recurrent subvalvular stenosis caused by a pericardial patch and 1 balloon dilatation was performed on a previously stented LPA. 100% follow-up for DPH patients operated before or outside the trial (n = 114) included in the ESPOIR Registry, age 16.6 ± 10.4 years, diameter 24.1 ± 4.2 mm, follow-up 5.1 ± 3.0 years. The combined DPH cohort, n = 235, comprising both Trial and Registry data showed significantly better freedom from explantation (DPH 96.7 ± 2.1%, CH 84.4 ± 3.2%, P = 0.029 and BJV 82.7 ± 3.2%, P = 0.012) and less structural valve degeneration at 10 years when matched to CH, n = 235 and BJV, n = 235 (DPH 61.4 ± 6.6%, CH 39.9 ± 4.4%, n.s., BJV 47.5 ± 4.5%, P = 0.029).

conclusionsInitial results of the prospective multicentre ESPOIR Trial showed DPH to be safe and efficient. Current DPH results including Registry data were superior to BJV and CH.Trial registration clinicaltrials.gov identifier: NCT02035540.

Indexed as

AllograftsEuropeFemaleHumansMaleProspective StudiesPulmonary ValveRegistriesTreatment OutcomeYoung AdultAllograftsDecellularizationHeart valve diseaseTissue engineering

Identifiers

PMID30879050
PMCPMC6735763

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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.