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, Vladimiro Vida, Massimo Padalino, Victor Tsang, Ramadan Jashari, Günther Laufer, Martin Andreas, Alexandra Andreeva, Igor Tudorache, Serghei Cebotari, Axel Haverich, Samir Sarikouch, Dmitry Bobylev, Alexander Horke, Dietmar Boethig, Mark Hazekamp, Bart Meyns, Filip Rega, Hitendu Dave, Martin Schmiady, Anatol Ciubotaru, Eduard Cheptanaru, Vladimiro Vida, Massimo Padalino, Victor Tsang, Ramadan Jashari, Günther Laufer, Martin Andreas, Alexandra Andreeva, Igor Tudorache, Serghei Cebotari, Axel Haverich, Samir Sarikouch

Abstract

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

Methods: A 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.

Results: A 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].

Conclusions: The 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.

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

© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.

Figures

Figure 1:
Figure 1:
Graphical overview of the study cohort.
Figure 2:
Figure 2:
Kaplan–Meier curves showing freedom from death, endocarditis, conduit-related catheter interventions and explantation in the upper row for the ESPOIR Trial cohort. The lower row shows freedom from transcatheter valve implantation, stenosis, regurgitation as well as freedom from combined degeneration and explantation.
Figure 3:
Figure 3:
Kaplan–Meier curves showing freedom from death, endocarditis, conduit related catheter interventions and explantation in the upper row for the total ESPOIR Registry cohort (n = 361), which includes the ESPOIR Trial patients. The lower row shows freedom from transcatheter valve implantation, stenosis, regurgitation and as well as freedom from combined degeneration and explantation for the ESPOIR Registry.
Figure 4:
Figure 4:
Kaplan–Meier curves for freedom from death, endocarditis, conduit-related catheter interventions, explantation are given in the upper row for matched cohorts of decellularized pulmonary homografts and conventional cryopreserved homografts. The lower row shows freedom from catheter valve implantation, stenosis, regurgitation, as well as freedom from combined degeneration and explantation. P-values for pairwise comparisons after 10 years are also given.
Figure 5:
Figure 5:
Freedom from explantation and functional conduit status for matched decellularized pulmonary homografts and cryopreserved homografts. We also analysed whether the yearly summarized fractions of intact decellularized pulmonary homografts during all the commonly observed years were larger than these fractions of cryopreserved homografts. Detailed pairwise comparisons including P-values are provided in Table 3.
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/9615428/bin/ezac219f6.jpg

References

    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. 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. Waqanivavalagi S, Bhat S, Ground MB, Milsom PF, Cornish J.. Clinical performance of decellularized heart valves versus standard tissue conduits: a systematic review and meta-analysis. J Cardiothorac Surg 2020;15:260.
    1. Boethig D, Horke A, Hazekamp M, Meyns B, Rega F, Van Puyvelde J. et al. A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry datadagger. Eur J Cardiothorac Surg 2019;56:503–9.
    1. Horke A, Bobylev D, Avsar M, Meyns B, Rega F, Hazekamp M. et al. Paediatric aortic valve replacement using decellularized allografts. Eur J Cardiothorac Surg 2020;58:817–24.
    1. Horke A, Tudorache I, Laufer G, Andreas M, Pomar JL, Pereda D. et al. Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data. Eur J Cardiothorac Surg 2020;58:1045–53.
    1. Sarikouch S, Theodoridis K, Hilfiker A, Boethig D, Laufer G, Andreas M. et al. Early insight into in vivo recellularization of cell-free allogenic heart valves. Ann Thorac Surg 2019;108:581–9.
    1. Ebken JM, Smart I, Ramm R, Goecke T, Jashari R, Böthig D. et al. Residual immune response towards decellularized homografts may be highly individual. Eur J Cardiothorac Surg 2021;59:773–82. 2021.
    1. Coti I, Wenda S, Andreeva A, Kocher A, Laufer G, Fischer G. et al. Donor-specific HLA antibodies after fresh decellularized vs cryopreserved native allograft implantation. HLA 2020;96:580–8.
    1. Baumgartner H, De Backer J.. The ESC clinical practice guidelines for the management of adult congenital heart disease 2020. Eur Heart J 2020;41:4153–4.
    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. Boethig D, AvsarM,BauerUMM,SarikouchS, P, Berger F et al; National Register For Congenital Heart Defects Investigators. Pulmonary valve prostheses: patient's lifetime procedure load and durability. Evaluation of the German National Register for Congenital Heart Defects. Interact Cardiovasc Thorac Surg 2022;34:297-306.
    1. d'Udekem Y. Decellularized homografts: in fashion or really superior? Eur J Cardiothorac Surg 2016;50:291–2.
    1. Nordmeyer J, Ewert P, Gewillig M, AlJufan M, Carminati M, Kretschmar O. et al. Acute and midterm outcomes of the post-approval MELODY Registry: a multicentre registry of transcatheter pulmonary valve implantation. Eur Heart J 2019;40:2255–64.
    1. Abdelghani M, Nassif M, Blom NA, Van Mourik MS, Straver B, Koolbergen DR. et al. Infective endocarditis after melody valve implantation in the pulmonary position: a systematic review. J Am Heart Assoc 2018;7:e008163.
    1. Jashari R. Transplantation of cryopreserved human heart valves in Europe: 30 years of banking in Brussels and future perspectives. Cell Tissue Bank 2021;22:519–37.
    1. Huygens SA, Rutten-van Molken M, Noruzi A, Etnel JRG, Corro Ramos I, Bouten CVC. et al. What is the potential of tissue-engineered pulmonary valves in children? Ann Thorac Surg 2019;107:1845–53.
    1. Wolkers WF, Hilfiker A.. Freeze-drying of decellularized heart valves for off-the-shelf availability. Methods Mol Biol 2021;2180:731–9.
    1. Ramm RG, Köhler P, Tudorache I, Cebotari S, Ciubotaru A, Sarikouch S. et al. Immunological and functional features of decellularized xenogenic heart valves after transplantation into GGTA1-KO pigs. Regen Biomater 2021;8:rbab036.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel