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, Massimo Padalino, Viktor Tsang, Ramadan Jashari, Dmitry Bobylev, Igor Tudorache, Serghei Cebotari, Axel Haverich, Samir Sarikouch, Dietmar Boethig, Alexander Horke, Mark Hazekamp, Bart Meyns, Filip Rega, Joeri Van Puyvelde, Michael Hübler, Martin Schmiady, Anatol Ciubotaru, Giovanni Stellin, Massimo Padalino, Viktor Tsang, Ramadan Jashari, Dmitry Bobylev, Igor Tudorache, Serghei Cebotari, Axel Haverich, Samir Sarikouch

Abstract

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.gov identifier: NCT02035540.

Keywords: Allografts; Decellularization; Heart valve disease; Tissue engineering.

© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.

Figures

Figure 1:
Figure 1:
Patient inclusion within the prospective multicentre ESPOIR Trial by centre.
Figure 2:
Figure 2:
Survival and freedom from endocarditis for DPH, CH and BJV cohorts. Detailed comparisons including log-rank test results are provided within Table 2. BJV: bovine jugular vein; CH: cryopreserved homografts; DPH: decellularized pulmonary homografts.
Figure 3:
Figure 3:
(A) Echocardiographic peak gradient over time for DPH, CH and BJV differentiated by the residual immediate implantation result (below or above 20 mmHg). (B) Regurgitation grade over time differentiated by immediate postoperative valve competence (below or above mild regurgitation). (C) Z-value development over time for DPH and BJV differentiated by the initial z-score at implantation (oversized >2z, normsized −2/+2z or undersized <−2z). BJV: bovine jugular vein conduits; CH: cryopreserved conventional homografts; DPH: decellularized pulmonary homografts.
Figure 4:
Figure 4:
Freedom from explantation and functional conduit status for DPH, CH and BJV cohorts. Log-rank test results for freedom of explantation are shown, detailed comparisons are provided within Table 2. BJV: bovine jugular vein conduits; CH: cryopreserved conventional homografts; DPH: decellularized pulmonary homografts.
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/6735763/bin/ezz054f5.jpg

References

    1. Morgan GJ. Pulmonary regurgitation- is the future percutaneous or surgical? Front Pediatr 2018;6:184..
    1. Martin MH, Meadows J, McElhinney DB, Goldstein BH, Bergersen L, Qureshi AM. et al. Safety and feasibility of melody transcatheter pulmonary valve replacement in the native right ventricular outflow tract: a Multicenter Pediatric Heart Network Scholar Study. JACC Cardiovasc Interv 2018;11:1642–50.
    1. Bibevski S, Ruzmetov M, Fortuna RS, Turrentine MW, Brown JW, Ohye RG.. Performance of synergraft decellularized pulmonary allografts compared with standard cryopreserved allografts: results from multiinstitutional data. Ann Thorac Surg 2017;103:869–74.
    1. Sarikouch S, Horke A, Tudorache I, Beerbaum P, Westhoff-Bleck M, Boethig D. et al. Decellularized fresh homografts for pulmonary valve replacement: a decade of clinical experience. Eur J Cardiothorac Surg 2016;50:281–90.
    1. Alexander ME. Finding the next good thing. J Thorac Cardiovasc Surg 2017;153:1555–6.
    1. D’Udekem Y. Decellularized homografts: in fashion or really superior? Eur J Cardiothorac Surg 2016;50:291..
    1. Helder MR, Kouchoukos NT, Zehr K, Dearani JA, Maleszewski JJ, Leduc C. et al. Late durability of decellularized allografts for aortic valve replacement: a word of caution. J Thorac Cardiovasc Surg 2016;152:1197–9.
    1. Etnel JRG, Suss PH, Schnorr GM, Veloso M, Colatusso DF, Balbi Filho EM. et al. Fresh decellularized versus standard cryopreserved pulmonary allografts for right ventricular outflow tract reconstruction during the Ross procedure: a propensity-matched study. Eur J Cardiothorac Surg 2018;54:434–40.
    1. da Costa FDA, Etnel JRG, Charitos EI, Sievers HH, Stierle U, Fornazari D. et al. Decellularized versus standard pulmonary allografts in the ross procedure: propensity-matched analysis. Ann Thorac Surg 2018;105:1205–13.
    1. da Costa FDA, Etnel JRG, Torres R, Balbi Filho EM, Torres R, Calixto A. et al. Decellularized allografts for right ventricular outflow tract reconstruction in children. World J Pediatr Congenit Heart Surg 2017;8:605–12.
    1. Cebotari S, Tudorache I, Ciubotaru A, Boethig D, Sarikouch S, Goerler A. et al. Use of fresh decellularized allografts for pulmonary valve replacement may reduce the reoperation rate in children and young adults: early report. Circulation 2011;124:S115–23.
    1. Sandica E, Boethig D, Blanz U, Goerg R, Haas NA, Laser KT. et al. Bovine jugular veins versus homografts in the pulmonary position: an analysis across two centers and 711 patients-conventional comparisons and time status graphs as a new approach. Thorac Cardiovasc Surg 2016;64:25–35.
    1. Ferraz Cavalcanti PE, Sa MP, Santos CA, Esmeraldo IM, de Escobar RR, de Menezes AM. et al. Pulmonary valve replacement after operative repair of tetralogy of Fallot: meta-analysis and meta-regression of 3,118 patients from 48 studies. J Am Coll Cardiol 2013;62:2227–43.
    1. Khanna AD, Hill KD, Pasquali SK, Wallace AS, Masoudi FA, Jacobs ML. et al. Benchmark outcomes for pulmonary valve replacement using the Society of Thoracic Surgeons Databases. Ann Thorac Surg 2015;100:138–45; discussion 145–6.
    1. Meijer FMM, Kies P, Jongbloed MRM, Hazekamp MG, Koolbergen DR, Blom NA. et al. Excellent durability of homografts in pulmonary position analysed in a predefined adult group with tetralogy of Fallot. Interact CardioVasc Thorac Surg 2019;28:279–83.
    1. Romeo JLR, Mokhles MM, van de Woestijne P, de Jong P, van den Bosch A, van Beynum IM. et al. Long-term clinical outcome and echocardiographic function of homografts in the right ventricular outflow tract. Eur J Cardiothorac Surg 2019;55:518--26.
    1. Bokma JP, Winter MM, Oosterhof T, Vliegen HW, van Dijk AP, Hazekamp MG. et al. Individualised prediction of pulmonary homograft durability in tetralogy of Fallot. Heart 2015;101:1717–23.
    1. Mercer CW, West SC, Sharma MS, Yoshida M, Morell VO.. Polytetrafluoroethylene conduits versus homografts for right ventricular outflow tract reconstruction in infants and young children: an institutional experience. J Thorac Cardiovasc Surg 2018;155:2082–91.e1.
    1. Bobylev D, Sarikouch S, Tudorache I, Cvitkovic T, Soylen B, Boethig D. et al. Double semilunar valve replacement in complex congenital heart disease using decellularized homografts. Interact CardioVasc Thorac Surg 2019;28:151–7.
    1. (18 February 2019, date last accessed).

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir