4 . 2017

Aortic valve replacement using Perceval S bioprothesis

Abstract

Aim. А multicenter, prospective, nonrandomized, clinical trial was developed to assess the efficacy and safety of the sutureless aortic bioprosthesis Perceval S in the surgical treatment of aortic valve injury in the elderly patients. Clinical and echocardiographic observation was carried out at the hospital stage and after discharge from the hospital in 3, 6, 12, 24 and 36 months.

Methods. 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. In the period from 2013 to 2017, 51 patients were operated (mean age 71±12 years). Isolated aortic stenosis was found in 90%, and insufficiency in 10% cases. The average EuroSCORE was 13.18%, and the III–IV functional class by NYHA was 93.3% and 6.7% respectively. The sizes of the implanted valves were 21, 23 and 25 mm. 20 (40%) patients underwent CABG, in some cases with MV plasty. 6% – MV plasty only.

Results. Mean cross clumping time and CPB time was 31±12 and 59±18 min respectively. 1 (12%) case of hospital non-valve related mortality was detected. In the long-term (up to 36 months) follow-up there were no deaths. A total of 42 patients were evaluated at 3, 6, 12, 24 and 36 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.

Conclusion. The preliminary results of the study confirm the safety and effectiveness of the su- tureless aortic valve bioprosthesis Perceval S. In the group of moderate and high risk patients, reduction of CPB and cross-clamping time, as well as a significant reduction of well-known complications of aortic valve replacement can help reduce mortality and morbidity of mid- and long-term outcomes. The sutureless technique could be a promising alternative to biological aortic valve replacement.

Keywords:aortic valve replacement, sutureless heart valve prosthesis, prospective study, Perceval S

Clin. Experiment. Surg. Petrovsky J. 2017; 5 (4): 30–6.

Received: 14.09.2017. Accepted: 10.10.2017.

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