Aortic Valve Replacement Using Perceval S Bioprosthesis. Multicentral, Prospective, Non-randomised Study
- #AC/VAL 02-EP-6
- Adult Cardiac Surgery/Valves. E-POSTER (ORAL) SESSION 2
- E-Poster (oral)
Aortic Valve Replacement Using Perceval S Bioprosthesis. Multicentral, Prospective, Non-randomised Study
Vadim Dalinin 1, Igor Borisov 1, Alexey Kuznecov 2, Dmitriy Andreev 2
1 Mandrika Central Millitary Hospital, Moscow, Russia; 2 Khabarovsk Federal center for cardiovascular surgery, Khabarovsk, Russia;
Date, time and location: 2018.05.25 13:30, Exhibition area, 1st Floor. Zone – D
Abstract
A multicenter, prospective, nonrandomized, clinical trial was developed to assess the efficacy and safety of the sutureless aortic bioprostheses Perceval S in the surgical treatment of aortic valve injury in the patients over 60. Clinical and echocardiographic observation was carried out at the hospital stage and after discharge from the hospital from three to forty-eight months.The valve was implanted through sternotomy, on CPB and after removal of the native valve. The valve was implanted without suturing. Optimum fitting in the aortic position was provided by balloon adaptation at low pressure. If CABG or any valve surgery was also required, the combined procedures were performed first. From 2013 61 patients were operated (mean age 71). Isolated aortic stenosis was found in 90%, and insufficiency in 10%. The average EuroSCORE was 13.18%. 40% underwent CABG, in some cases with MV plasty. 6% - MV plasty only.
Results: mean cross clumping time and CPB time was 31 ± 12 min and 59 ± 18 min respectively. One case of hospital non-valve related mortality was detected. In the long-term follow-up mortality was not noted. A total of 48 patients were evaluated from 3 to 48 months after implantation. There were no cases of valve migration. The cases of conduction disturbance that required the pacemaker installation were not observed during the entire observation period.
The preliminary results of the study confirm the safety and effectiveness of the sutureless aortic valve bioprostheses Perceval S. In the group of moderate and high risk patients, reducing the CPB and cross clumping time, as well as a significant reduction in well-known complications of aortic valve replacement can help reduce mortality and morbidity and mid- and long-term outcomes.The sutureless technique could be an alternative to the standart biological aortic valve replacement.