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

GND
122052501
ORCID
0000-0002-9199-1721
Affiliation
Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School
Boethig, Dietmar;
GND
1261503732
ORCID
0000-0002-4578-1547
Affiliation
Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School
Horke, Alexander;
ORCID
0000-0002-3150-5007
Affiliation
Department of Congenital Cardiac Surgery, Leiden University Medical Center, Leiden, Netherlands
Hazekamp, Mark;
ORCID
0000-0002-8110-4009
Affiliation
Department of Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium
Meyns, Bart;
ORCID
0000-0002-8428-2302
Affiliation
Department of Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium
Rega, Filip;
ORCID
0000-0003-2003-2029
Affiliation
Department of Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium
Van Puyvelde, Joeri;
GND
129529206
ORCID
0000-0001-7169-6330
Affiliation
Division of Congenital Cardiovascular Surgery, University Children’s Hospital, Zurich, Switzerland
Hübler, Michael;
ORCID
0000-0003-0210-7904
Affiliation
Division of Congenital Cardiovascular Surgery, University Children’s Hospital, Zurich, Switzerland
Schmiady, Martin;
ORCID
0000-0003-1045-4009
Affiliation
Cardiac Surgery Center, State Medical and Pharmaceutical University, Chisinau, Moldova
Ciubotaru, Anatol;
ORCID
0000-0002-1903-2542
Affiliation
Pediatric and Congenital Cardiac Surgery Unit, Azienda Ospedaliera di Padova, University of Padua Medical School, Padova, Ital
Stellin, Giovanni;
ORCID
0000-0002-7535-9670
Affiliation
Pediatric and Congenital Cardiac Surgery Unit, Azienda Ospedaliera di Padova, University of Padua Medical School, Padova, Italy
Padalino, Massimo;
Affiliation
Department of Cardiothoracic Surgery, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK
Tsang, Viktor;
ORCID
0000-0002-0867-1998
Affiliation
European Homograft Bank, Clinique Saint-Jean, Bruessels, Belgium
Jashari, Ramadan;
GND
1078006989
ORCID
0000-0002-3961-8348
Affiliation
Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany
Bobylev, Dmitry;
GND
138604703
ORCID
0000-0003-2367-3606
Affiliation
Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany
Tudorache, Igor;
GND
130203203
ORCID
0000-0002-3713-3670
Affiliation
Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany
Cebotari, Serghei;
GND
130344761
ORCID
0000-0002-0991-2650
Affiliation
Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany
Haverich, Axel;
GND
173060498
ORCID
0000-0001-7277-7597
Affiliation
Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany
Sarikouch, Samir

OBJECTIVES: Decellularized pulmonary homografts (DPH) have shown excellent results for pulmonary valve replacement. However, controlled multicentre studies are lacking to date. METHODS: Prospective 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. RESULTS: In 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).CONCLUSIONS: Initial 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

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