Dmitry Bobylev1, Alexander Horke1, Dietmar Boethig1, Mark Hazekamp2, Bart Meyns3, Filip Rega3, Hitendu Dave4, Martin Schmiady4, Anatol Ciubotaru5, Eduard Cheptanaru5, Vladimiro Vida6, Massimo Padalino6, Victor Tsang7, Ramadan Jashari8, Günther Laufer9, Martin Andreas9, Alexandra Andreeva9, Igor Tudorache1, Serghei Cebotari1, Axel Haverich1, Samir Sarikouch1. 1. Department for Cardiothoracic, Transplant, and Vascular Surgery, Hannover Medical School, Hannover, Germany. 2. Department of Congenital Cardiac Surgery, Leiden University Medical Center, Leiden, Netherlands. 3. Department of Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium. 4. Division of Congenital Cardiovascular Surgery, University Children's Hospital, Zurich, Switzerland. 5. Cardiac Surgery Center, State Medical and Pharmaceutical University, Chisinau, Moldova. 6. Pediatric and Congenital Cardiac Surgery Unit, Azienda Ospedaliera di Padova, University of Padua Medical School, Padua, Italy. 7. Department of Cardiothoracic Surgery, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK. 8. European Homograft Bank, Clinique Saint-Jean, Brussel, Belgium. 9. Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
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.
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.
Authors: Firdavs Oripov; Robert Ramm; Christine Falk; Tobias Goecke; Johannes Ebken; Ramadan Jashari; Dietmar Böthig; Alexander Horke; Murat Avsar; Dmitry Bobylev; Axel Haverich; Andres Hilfiker; Samir Sarikouch Journal: Front Cardiovasc Med Date: 2022-08-09