Department of Cardiac Surgery, Klinikum Nürnberg, Nuremberg, Germany.
Ann Thorac Surg. 2012 Aug;94(2):504-8; discussion 508-9. doi: 10.1016/j.athoracsur.2012.04.024. Epub 2012 Jun 12.
Sutureless aortic bioprostheses bear the potential of easy implantation, reduced ischemic time, and surgical trauma in aortic valve replacement. We herein show our clinical and echocardiographic results after a 1-year experience with a new sutureless bioprosthesis.
The Perceval S (Sorin Biomedica Cardio Srl, Saluggia, Italy) is a pericardial aortic prosthesis assembled within a super-elastic alloy frame. It is implanted intra-annularly, without the need of suture. As part of a premarketing multicenter study (Cavalier Trial), since March 2010, 83 patients were screened for implantation in our center.
The patients received a size S (4), M (38), or L (41) prosthesis, either as isolated (57) or combined procedures (26). Fifty-one patients (61.5%) received a "J" sternotomy. Mean logistic European system for cardiac operative risk evaluation was 10.±7.5%, mean aortic cross-clamp time was 43.8±20.8 minutes (36±12.7 minutes for isolated procedures). Mean implantation time was 8±3.8 minutes (range 4 to 28 minutes). In-hospital mortality was 2.4% (1 patient for multiorgan failure and 1 for liver insufficiency); mean hospital stay was 11.5±4.4 days (range 2 to 28 days). We recorded 5 pacemaker implantations (6%). At follow-up, we had 2 deaths (1 patient for congestive heart failure and 1 for gastrointestinal bleeding). At 1 year, mean New York Heart Association functional class was 1.0±0.6. Mean transprosthetic gradients were 13.4±2.8, 12.6±2.3, and 10.8±1.3 mm Hg postoperatively, at 6 months, and at 1 year, respectively.
The Perceval S shows satisfactory clinical and hemodynamic results. Due to its simple implantation technique, it represents an alternative especially for minimally invasive surgery. Operative trauma can be minimized by short aortic cross-clamp time.
无缝线主动脉生物瓣具有易于植入、减少缺血时间和手术创伤的潜力,可用于主动脉瓣置换术。我们在此展示了我们在使用一种新型无缝线生物瓣 1 年后的临床和超声心动图结果。
Perceval S(Sorin Biomedica Cardio Srl,Saluggia,意大利)是一种心包制成的主动脉假体,装配在超弹性合金框架内。它通过环形内植入,无需缝线。作为上市前多中心研究(Cavalier 试验)的一部分,自 2010 年 3 月以来,我们中心对 83 名患者进行了筛选以进行植入。
患者植入了 S(4)、M(38)或 L(41)尺寸的假体,分别为孤立(57)或联合手术(26)。51 名患者(61.5%)接受了“J”型胸骨切开术。平均逻辑欧洲心脏手术风险评估系统为 10.±7.5%,平均主动脉阻断时间为 43.8±20.8 分钟(孤立手术为 36±12.7 分钟)。平均植入时间为 8±3.8 分钟(范围为 4 至 28 分钟)。院内死亡率为 2.4%(1 例因多器官衰竭,1 例因肝功能不全);平均住院时间为 11.5±4.4 天(范围为 2 至 28 天)。我们记录了 5 例起搏器植入(6%)。随访时,我们有 2 例死亡(1 例因充血性心力衰竭,1 例因胃肠道出血)。1 年后,平均纽约心脏协会功能分级为 1.0±0.6。术后、术后 6 个月和 1 年的平均跨瓣梯度分别为 13.4±2.8、12.6±2.3 和 10.8±1.3mmHg。
Perceval S 显示出令人满意的临床和血液动力学结果。由于其简单的植入技术,它尤其适用于微创手术。通过缩短主动脉阻断时间,可以最大限度地减少手术创伤。