Theodor Fischlein1, Bart Meuris2, Thierry Folliguet3, Kavous Hakim-Meibodi4, Martin Misfeld5, Thierry Carrel6, Marian Zembala7, Elisa Cerutti8, Federico M Asch9, Axel Haverich10. 1. Klinikum Nürnberg, Cardiovascular Center, Paracelsus Medical University, Nuremberg, Germany. Electronic address: Theodor.Fischlein@klinikum-nuernberg.de. 2. Cardiac Surgery, UZ Gasthuisberg, Leuven, Belgium. 3. Cardiac Surgery and Transplantation, Hôpital Henri Mondor assistance Publique Hôpitaux de Paris, Paris, France. 4. Department of Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany. 5. Department of Cardiac Surgery, Herzzentrum Universitaet Leipzig, Klinik fur Herzchirurgie, Leipzig, Germany; Department of Cardiothoracic Surgery, Royal Prince Alfred Hospital, Sydney, Australia. 6. Cardiovascular Surgery, Inselspital, Bern, Switzerland. 7. Department of Cardiac, Vascular and Endovascular Surgery and Transplantology, School of Medicine, Silesian Center for Heart Diseases, Zabrze, Poland. 8. Clinical Affairs Department, LivaNova plc, London, United Kingdom. 9. MedStar Health Research Institute, Washington Hospital Center, Washington, DC. 10. Cardio-thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Abstract
OBJECTIVE: The objective of this study was to report midterm clinical outcomes with a self-expandable sutureless aortic valve. METHODS: Between 2010 and 2013, 658 patients at 25 European institutions received the Perceval sutureless valve (LivaNova Plc, London, United Kingdom). Mean follow-up was 3.8 years; late cumulative follow-up was 2325.2 patient-years. RESULTS: The mean age of the population was 78.3 ± 5.6 years and 40.0% (n = 263) were 80 years of age or older; mean Society of Thoracic Surgeons-Predicted Risk of Mortality score was 7.2 ± 7.4. Concomitant procedures were performed in 31.5% (n = 207) of patients. Overall duration of cardiopulmonary bypass time was 64.8 ± 25.2 minutes and aortic cross-clamping time was 40.7 ± 18.1 minutes. Thirty-day all-cause mortality was 3.7% (23 patients), with an observed:expected ratio of 0.51. Overall survival was 91.6% at 1 year, 88.5% at 2 years, and 72.7% at 5 years. Peak and mean gradients remained stable during follow-up, and were 17.8 ± 11.3 mm Hg and 9.0 ± 6.3 mm Hg, respectively, at 5 years. Preoperatively, 33.4% of those who received the Perceval valve (n = 210) were in New York Heart Association functional class I or II versus 93.1% (n = 242) at 5 years. CONCLUSIONS: This series, representing, to our knowledge, the longest follow-up with sutureless technology in a prospective, multicenter study, shows that aortic replacement using sutureless valves is associated with low mortality and morbidity and good hemodynamic performance.
OBJECTIVE: The objective of this study was to report midterm clinical outcomes with a self-expandable sutureless aortic valve. METHODS: Between 2010 and 2013, 658 patients at 25 European institutions received the Perceval sutureless valve (LivaNova Plc, London, United Kingdom). Mean follow-up was 3.8 years; late cumulative follow-up was 2325.2 patient-years. RESULTS: The mean age of the population was 78.3 ± 5.6 years and 40.0% (n = 263) were 80 years of age or older; mean Society of Thoracic Surgeons-Predicted Risk of Mortality score was 7.2 ± 7.4. Concomitant procedures were performed in 31.5% (n = 207) of patients. Overall duration of cardiopulmonary bypass time was 64.8 ± 25.2 minutes and aortic cross-clamping time was 40.7 ± 18.1 minutes. Thirty-day all-cause mortality was 3.7% (23 patients), with an observed:expected ratio of 0.51. Overall survival was 91.6% at 1 year, 88.5% at 2 years, and 72.7% at 5 years. Peak and mean gradients remained stable during follow-up, and were 17.8 ± 11.3 mm Hg and 9.0 ± 6.3 mm Hg, respectively, at 5 years. Preoperatively, 33.4% of those who received the Perceval valve (n = 210) were in New York Heart Association functional class I or II versus 93.1% (n = 242) at 5 years. CONCLUSIONS: This series, representing, to our knowledge, the longest follow-up with sutureless technology in a prospective, multicenter study, shows that aortic replacement using sutureless valves is associated with low mortality and morbidity and good hemodynamic performance.
Authors: Theodor Fischlein; Elena Caporali; Federico M Asch; Ferdinand Vogt; Francesco Pollari; Thierry Folliguet; Utz Kappert; Bart Meuris; Malakh L Shrestha; Eric E Roselli; Nikolaos Bonaros; Olivier Fabre; Pierre Corbi; Giovanni Troise; Martin Andreas; Frederic Pinaud; Steffen Pfeiffer; Sami Kueri; Erwin Tan; Pierre Voisine; Evaldas Girdauskas; Filip Rega; Julio García-Puente; Laurent De Kerchove; Roberto Lorusso Journal: Front Cardiovasc Med Date: 2022-02-18