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... Show moreOBJECTIVES: 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. Show less
Horke, A.; Tudorache, I.; Laufer, G.; Andreas, M.; Pomar, J.L.; Pereda, D.; ... ; Sarikouch, S. 2020
OBJECTIVES: Decellularized aortic homografts (DAH) may provide an additional aortic valve replacement option for young patients due to their potential to overcome the high early failure rate of... Show moreOBJECTIVES: Decellularized aortic homografts (DAH) may provide an additional aortic valve replacement option for young patients due to their potential to overcome the high early failure rate of conventional allogenic and xenogenic aortic valve prostheses.METHODS: A prospective, European Union-funded, single-arm, multicentre, safety study was conducted in 8 centres evaluating non-cryopreserved DAH for aortic valve replacement.RESULTS: One hundred and forty-four patients (99 male) were prospectively enrolled between October 2015 and October 2018, mean age 33.6 +/- 20.8 years; 45% had undergone previous cardiac operations. Mean implanted DAH diameter 22.6 +/- 2.4 mm and mean durations for the operation, cardiopulmonary bypass and cross-clamp were 341 +/- 140, 174 +/- 80 and 126 +/- 43 min, respectively. There were 2 early deaths (1 LCA thrombus on day 3 and 1 ventricular arrhythmia 5 h postop) and 1 late death due to endocarditis 4 months postoperatively, resulting in a total mortality of 2.08%. One pacemaker implantation was necessary and 1 DAH was successfully repaired after 6 weeks for early regurgitation following subcoronary implantation. All other DAH were implanted as a free-standing root. After a mean follow-up of 1.54 +/- 0.81 years, the primary efficacy end points peak gradient (mean 11.8 +/- 7.5 mmHg) and regurgitation (mean 0.42 +/- 0.49, grade 0-3) were excellent. At 2.5 years, freedom from explantation/endocarditis/bleeding/stroke was 98.4 +/- 1.1%/99.4 +/- 0.6%/99.1 +/- 0.9%/99.2 +/- 0.8%, respectively, with results almost identical to those in an age-matched Ross operation cohort of 212 patients (mean age 34 years) despite DAH patients having undergone >2x more previous procedures.CONCLUSIONS: The initial results of the prospective multicentre ARISE trial show DAH to be safe for aortic valve replacement with excellent haemodynamics in the short follow-up period. Show less
Boethig, D.; Horke, A.; Hazekamp, M.; Meyns, B.; Rega, F.; Puyvelde, J. van; ... ; Sarikouch, S. 2019
OBJECTIVES: Decellularized pulmonary homografts (DPH) have shown excellent results for pulmonary valve replacement. However, controlled multicentre studies are lacking to date.METHODS: Prospective... Show moreOBJECTIVES: 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. Show less
