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

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: NCT 02035540.

Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data

“…We have shown the absence of calcium in a DAH reoperation 4.5 years after implantation in an infant [ 9 ] and extensive in vivo recellularization with non-immunogenic recipient cells in decellularized pulmonary and aortic allografts [ 26 ]. Decellularized pulmonary homografts showed significantly higher freedom from reoperation at 10 years compared with cryopreserved pulmonary homografts and almost no early cellular immune response [ 10 , 27 ]. The promising initial clinical results for DAH [ 9 ] led to the initiation of prospective multicentre trial, whose early results are reported here.…”

Pressurized Perfusion System for Obtaining Completely Acellular Pulmonary Valve Scaffolds for Tissue Engineering

“…At the moment there is an interest regarding decellularized pulmonary valve, studies entering the translational phase. The on-going ESPOIR trial targeting patients aged 21.3 ± 14.4, aims to compare decellularized homografts to the current alternatives -the bovine jugular vein conduit -Contegra conduit (30) and cryopreserved homografts, their initial results from registry data showed their superiority (31). The ARISE trial represents a further step, targeting the pediatric valve replacement using decellularized aortic homografts (32).…”

Which Biological Properties of Heart Valves Are Relevant to Tissue Engineering?

“…At the current time, the in situ approach to tissue engineering heart valves has made the most progress with a number of in vivo studies in animals, and with delivery of the valve using transcatheter implantation, showing encouraging results (89,(93)(94)(95). This approach has also been the avenue for the small number of past and present clinicial trials of tissue engineered heart valves, most often employing decellularized homografts for use in the pulmonary valve position (96).…”