Evidence map›Paper›PMID 35425983›Full record

ArticleEuropean journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery2022

5-Year results from the prospective European multi-centre study on decellularized homografts for pulmonary valve replacement ESPOIR Trial and ESPOIR Registry data.

Dmitry Bobylev, Alexander Horke, Dietmar Boethig, Mark Hazekamp, Bart Meyns, Filip Rega, Hitendu Dave, Martin Schmiady, Anatol Ciubotaru, Eduard Cheptanaru and 11 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter Study
In one paragraph

Article in European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2022. 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 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
5.4field-weighted citation impact, top 3% 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.

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

14 citing papers in PubMed, 27 citations in OpenAlex.

  1. Article
  2. Article
  3. 20-Year Experience With Decellularized Pulmonary Homografts for Pulmonary Valve Replacement.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2026
    Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Decellularized aortic homografts versus mechanical composite grafts for aortic root replacement.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2024
    Article
  11. Article
  12. Article
  13. Review
  14. 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

21 authors at 9 institutions in 8 countries.

Dmitry BobylevDepartment for Cardiothoracic, Transplant, and Vascular Surgery, Hannover Medical School, Hannover, Germany.ORCID 0000-0002-3961-8348
Alexander HorkeDepartment for Cardiothoracic, Transplant, and Vascular Surgery, Hannover Medical School, Hannover, Germany.ORCID 0000-0002-4578-1547
Dietmar BoethigDepartment for Cardiothoracic, Transplant, and Vascular Surgery, Hannover Medical School, Hannover, Germany.ORCID 0000-0002-9199-1721
Mark HazekampDepartment of Congenital Cardiac Surgery, Leiden University Medical Center, Leiden, Netherlands.
Bart MeynsDepartment of Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium.ORCID 0000-0002-8110-4009
Filip RegaDepartment of Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium.ORCID 0000-0002-8428-2302
Hitendu DaveDivision of Congenital Cardiovascular Surgery, University Children's Hospital, Zurich, Switzerland.ORCID 0000-0003-0928-9472
Martin SchmiadyDivision of Congenital Cardiovascular Surgery, University Children's Hospital, Zurich, Switzerland.
Anatol CiubotaruCardiac Surgery Center, State Medical and Pharmaceutical University, Chisinau, Moldova.
Eduard CheptanaruCardiac Surgery Center, State Medical and Pharmaceutical University, Chisinau, Moldova.
Vladimiro VidaPediatric and Congenital Cardiac Surgery Unit, Azienda Ospedaliera di Padova, University of Padua Medical School, Padua, Italy.ORCID 0000-0002-1829-0259
Massimo PadalinoPediatric and Congenital Cardiac Surgery Unit, Azienda Ospedaliera di Padova, University of Padua Medical School, Padua, Italy.
Victor TsangDepartment of Cardiothoracic Surgery, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.
Ramadan JashariEuropean Homograft Bank, Clinique Saint-Jean, Brussel, Belgium.
Günther LauferDepartment of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.ORCID 0000-0001-7257-110X
Martin AndreasDepartment of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.ORCID 0000-0003-4950-5432
Alexandra AndreevaDepartment of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.ORCID 0000-0002-4379-7924
Igor TudoracheDepartment for Cardiothoracic, Transplant, and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Serghei CebotariDepartment for Cardiothoracic, Transplant, and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Axel HaverichDepartment for Cardiothoracic, Transplant, and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Samir SarikouchDepartment for Cardiothoracic, Transplant, and Vascular Surgery, Hannover Medical School, Hannover, Germany.ORCID 0000-0001-7277-7597
Medizinische Hochschule Hannover · DEMedical University of Vienna · ATKU Leuven · BEMoldova State University · MDUniversity Children's Hospital Zurich · CHUniversity of Padua · ITClinique Saint Jean · BEGreat Ormond Street Hospital for Children NHS Foundation Trust · GBLeiden University Medical Center · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesEarly results from the prospective ESPOIR Trial have indicated excellent results for pulmonary valve replacement using decellularized pulmonary homografts (DPH).

methodsA 5-year analysis of ESPOIR Trial patients was performed to provide an insight into the midterm DPH performance. ESPOIR Trial and Registry patients were matched with cryopreserved homografts (CH) patients considering patient age, type of heart defect and previous procedures to present the overall experience with DPH.

resultsA total of 121 patients (59 female) were prospectively enrolled (8/2014-12/2016), median age 16.5 years (interquartile range 11.2-29.8), and median DPH diameter 24 mm. One death (73 year-old) occurred during a median follow-up of 5.9 years (5.4-6.4), in addition to 2 perioperative deaths resulting in an overall mortality rate of 2.5%. One case of endocarditis in 637 patient-years was noticed, resulting in an incidence of 0.15% per patient-year. At 5 years, the mean peak gradient was 19.9 mmHg (9.9), mean regurgitation 0.9 (0.6, grade 0-3) and freedom from explantation/any reintervention 97.5% (1.5). The combined DPH cohort, n = 319, comprising both Trial and Registry data, showed significantly better freedom from explantation for DPH 95.5% (standard deviation 1.7) than CH 83.0% (2.8) (P < 0.001) and less structural valve degeneration at 10 years when matched to 319 CH patients [DPH 65.5% (standard deviation 4.4) and CH 47.3% (3.7), P = 0.11].

conclusionsThe 5-year data of the prospective ESPOIR Trial show excellent performance for DPH and low rates of adverse events. ESPOIR Registry data up to 15 years, including a matched comparison with CH, demonstrated statistically significant better freedom from explantation.

Indexed as

Heart Valve ProsthesisHeart Valve Prosthesis ImplantationPulmonary ValveAdolescentAgedAllograftsAortic ValveFemaleFollow-Up StudiesHumansProspective StudiesRegistriesTreatment OutcomeAllograftsDecellularizationHeart valve diseaseTissue engineering

Identifiers

PMID35425983
PMCPMC9615428
OpenAlexW4221013839

What OpenQuestion holds

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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.