BACKGROUND AND AIM OF THE STUDY: A European, multicenter, prospective, non-randomized, clinical pilot trial was designed to evaluate the feasibility of the Perceval S sutureless aortic valve prosthesis. A clinical and echocardiographic follow up was performed at the time of hospital discharge and subsequently after one, three, six, and 12 months. METHODS: The valve was implanted following sternotomy, extracorporeal circulation (ECC), aortic cross-clamping, cardioplegic arrest, and removal of the native valve. Implantation suturing was not required. Optimal annular sealing was obtained with brief low-pressure balloon dilation. If coronary bypass was indicated, a distal anastomosis was performed first. Between April 2007 and February 2008, 30 patients (mean age: 81 +/- 4 years) underwent aortic valve replacement. The prevalence of pure aortic stenosis was 76.7%, and that of mixed lesion 23.3%. The mean logistic EuroSCORE was 13.18%, and the NYHA class was III and IV in 93.3% and 6.7% of patients, respectively. The implanted valve size was 21 and 23 mm in 37% and 63% of patients, respectively, and 14 (46.7%) underwent coronary artery bypass grafting (11 internal mammary artery, nine vein grafts). RESULTS: The mean aortic cross-clamp and ECC times were 34 +/- 15 min and 59 +/- 21 min, respectively. There was one in-hospital death (3.3%), and three deaths occurred within 12 months of follow up (one death was valve-related, and two deaths were independent of the valve implantation). A total of 28 patients was assessed at one month post-implantation, and 23 after 12 months. No migration or dislodgement of the valve had occurred, but there were two mild paravalvular leakages and two mild intravalvular insufficiencies. CONCLUSION: The preliminary results of the trial confirmed the safety and efficacy of the Perceval S sutureless aortic valve. In this high-risk subset of patients, shortening the aortic cross-clamp and ECC times may help to reduce mortality and morbidity.
BACKGROUND AND AIM OF THE STUDY: A European, multicenter, prospective, non-randomized, clinical pilot trial was designed to evaluate the feasibility of the Perceval S sutureless aortic valve prosthesis. A clinical and echocardiographic follow up was performed at the time of hospital discharge and subsequently after one, three, six, and 12 months. METHODS: The valve was implanted following sternotomy, extracorporeal circulation (ECC), aortic cross-clamping, cardioplegic arrest, and removal of the native valve. Implantation suturing was not required. Optimal annular sealing was obtained with brief low-pressure balloon dilation. If coronary bypass was indicated, a distal anastomosis was performed first. Between April 2007 and February 2008, 30 patients (mean age: 81 +/- 4 years) underwent aortic valve replacement. The prevalence of pure aortic stenosis was 76.7%, and that of mixed lesion 23.3%. The mean logistic EuroSCORE was 13.18%, and the NYHA class was III and IV in 93.3% and 6.7% of patients, respectively. The implanted valve size was 21 and 23 mm in 37% and 63% of patients, respectively, and 14 (46.7%) underwent coronary artery bypass grafting (11 internal mammary artery, nine vein grafts). RESULTS: The mean aortic cross-clamp and ECC times were 34 +/- 15 min and 59 +/- 21 min, respectively. There was one in-hospital death (3.3%), and three deaths occurred within 12 months of follow up (one death was valve-related, and two deaths were independent of the valve implantation). A total of 28 patients was assessed at one month post-implantation, and 23 after 12 months. No migration or dislodgement of the valve had occurred, but there were two mild paravalvular leakages and two mild intravalvular insufficiencies. CONCLUSION: The preliminary results of the trial confirmed the safety and efficacy of the Perceval S sutureless aortic valve. In this high-risk subset of patients, shortening the aortic cross-clamp and ECC times may help to reduce mortality and morbidity.
Authors: Marian Kukucka; Miralem Pasic; Stephan Dreysse; Semih Buz; Thorsten Drews; Alexander Mladenow; Helmut Habazettl; Hermann Kuppe; Axel Unbehaun; Roland Hetzer Journal: Ann Cardiothorac Surg Date: 2012-07
Authors: Marco Di Eusanio; Kevin Phan; Denis Bouchard; Thierry P Carrel; Otto E Dapunt; Roberto Di Bartolomeo; Harald C Eichstaedt; Theodor Fischlein; Thierry Folliguet; Borut Gersak; Mattia Glauber; Axel Haverich; Martin Misfeld; Peter J Oberwalder; Giuseppe Santarpino; Malakh Lal Shrestha; Marco Solinas; Marco Vola; Francesco Alamanni; Alberto Albertini; Gopal Bhatnagar; Michel Carrier; Stephen Clark; Federic Collart; Utz Kappert; Alfred Kocher; Bart Meuris; Carmelo Mignosa; Ahmed Ouda; Marc Pelletier; Parwis Baradaran Rahmanian; David Reineke; Kevin Teoh; Giovanni Troise; Emmanuel Villa; Thorsten Wahlers; Tristan D Yan Journal: Ann Cardiothorac Surg Date: 2015-03
Authors: Erik Beckmann; Andreas Martens; Firas Alhadi; Klaus Hoeffler; Julia Umminger; Tim Kaufeld; Samir Sarikouch; Nurbol Koigeldiev; Serghei Cebotari; Jan Dieter Schmitto; Axel Haverich; Malakh Shrestha Journal: Interact Cardiovasc Thorac Surg Date: 2016-02-25
Authors: Muhammet Onur Hanedan; Mehmet Ali Yuruk; Ali Ihsan Parlar; Ugur Ziyrek; Ali Kemal Arslan; Ufuk Sayar; Ilker Mataraci Journal: Tex Heart Inst J Date: 2018-02-01