Theodor Fischlein1, Bart Meuris2, Kavous Hakim-Meibodi3, Martin Misfeld4, Thierry Carrel5, Marian Zembala6, Sara Gaggianesi7, Francesco Madonna8, François Laborde9, Federico Asch10, Axel Haverich11. 1. Department of Cardiac Surgery, Paracelsus Medical University, Klinikum Nürnberg, Nuremberg, Germany. Electronic address: Theodor.Fischlein@klinikum-nuernberg.de. 2. Department of Cardiac Surgery, U.Z. Gasthuisberg, Leuven, Belgium. 3. Department of Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany. 4. Klinik fur Herzchirurgie, Herzzentrum Universitaet Leipzig, Leipzig, Germany. 5. Inselspital, Bern, Switzerland. 6. Department of Cardiac, Vascular and Endovascular Surgery and Transplantology, School of Medicine, Silesian Center for Heart Diseases, Zabrze, Poland. 7. Clinical Affairs Department, Sorin Group Italia Srl, Saluggia, Italy. 8. Hôpital Cardiologique Du Haut-Leveque, Pessac, France. 9. Cardiac Medico-Surgical Department, Institute Mutualiste Montsouris, Paris, France. 10. MedStar Cardiovascular Research Network, Washington Hospital Center, Washington, DC. 11. Department of Cardiothoracic, Transplantation & Vascular Surgery, Hannover Medical School, Germany.
Abstract
OBJECTIVE: Sutureless aortic valve replacement (AVR) offers an alternative to standard AVR in aortic stenosis. This prospective, single-arm study aimed to demonstrate safety and effectiveness of a bovine pericardial sutureless aortic valve at 1 year. METHODS: From February 2010 to September 2013, 658 patients (mean age 78.3 ± 5.6 years; 40.0% octogenarian; 64.4% female; mean Society of Thoracic Surgeons score 7.2 ± 7.4) underwent sutureless AVR in 25 European centers. Concomitant cardiac procedures were performed in 29.5% and minimally invasive cardiac surgery in 33.3%. RESULTS: One-year site-reported event rates were 8.1% for all-cause mortality, 4.5% for cardiac mortality, 3.0% for stroke, 1.9% for valve-related reoperation, 1.4% for endocarditis, and 0.6% for major paravalvular leak. No valve thrombosis, migration, or structural valve deterioration occurred. New York Heart Association class improved at least 1 level in 77.5% and remained stable (70.4% New York Heart Association class I or II at 1 year). Mean effective orifice area was 1.5 ± 0.4 cm(2); pressure gradient was 9.2 ± 5.0 mm Hg. Left ventricular mass decreased from 138.5 g/m(2) before surgery to 115.3 g/m(2) at 1 year (P < .001). Echocardiographic core laboratory findings confirmed that paravalvular leak was rare and remained stable during follow-up. CONCLUSIONS: The Perceval sutureless valve resulted in low 1-year event rates in intermediate-risk patients undergoing AVR. New York Heart Association class improved in more than three-quarters of patients and remained stable. These data support the safety and efficacy to 1 year of the Perceval sutureless valve in this intermediate-risk population.
OBJECTIVE: Sutureless aortic valve replacement (AVR) offers an alternative to standard AVR in aortic stenosis. This prospective, single-arm study aimed to demonstrate safety and effectiveness of a bovine pericardial sutureless aortic valve at 1 year. METHODS: From February 2010 to September 2013, 658 patients (mean age 78.3 ± 5.6 years; 40.0% octogenarian; 64.4% female; mean Society of Thoracic Surgeons score 7.2 ± 7.4) underwent sutureless AVR in 25 European centers. Concomitant cardiac procedures were performed in 29.5% and minimally invasive cardiac surgery in 33.3%. RESULTS: One-year site-reported event rates were 8.1% for all-cause mortality, 4.5% for cardiac mortality, 3.0% for stroke, 1.9% for valve-related reoperation, 1.4% for endocarditis, and 0.6% for major paravalvular leak. No valve thrombosis, migration, or structural valve deterioration occurred. New York Heart Association class improved at least 1 level in 77.5% and remained stable (70.4% New York Heart Association class I or II at 1 year). Mean effective orifice area was 1.5 ± 0.4 cm(2); pressure gradient was 9.2 ± 5.0 mm Hg. Left ventricular mass decreased from 138.5 g/m(2) before surgery to 115.3 g/m(2) at 1 year (P < .001). Echocardiographic core laboratory findings confirmed that paravalvular leak was rare and remained stable during follow-up. CONCLUSIONS: The Perceval sutureless valve resulted in low 1-year event rates in intermediate-risk patients undergoing AVR. New York Heart Association class improved in more than three-quarters of patients and remained stable. These data support the safety and efficacy to 1 year of the Perceval sutureless valve in this intermediate-risk population.
Authors: Domenico Paparella; Giuseppe Santarpino; Marco Moscarelli; Pietro Guida; Adriano De Santis; Khalil Fattouch; Luigi Martinelli; Roberto Coppola; Elisa Mikus; Alberto Albertini; Mauro Del Giglio; Renato Gregorini; Giuseppe Speziale Journal: Interact Cardiovasc Thorac Surg Date: 2021-07-26
Authors: Ahmed Mashhour; Konstantin Zhigalov; Marcin Szczechowicz; Sabreen Mkalaluh; Jerry Easo; Harald Eichstaedt; Dmitry Borodin; Jürgen Ennker; Alexander Weymann Journal: World J Cardiol Date: 2018-09-26