Shrestha Malakh, Folliguet Thierry, Meuris Bart, Dibie Alain, Bara Christoph, Herregods Marie-Christine, Khaladj Nawid, Hagl Christian, Flameng Willem, Laborde Francois, Haverich Axel
Division of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hanover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.
J Heart Valve Dis. 2009 Nov;18(6):698-702.
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.
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).
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.
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.
设计了一项欧洲多中心前瞻性非随机临床试验，以评估Perceval S无缝合主动脉瓣膜假体的可行性。在出院时以及随后的1个月、3个月、6个月和12个月进行临床和超声心动图随访。
通过胸骨切开术、体外循环（ECC）、主动脉交叉钳夹、心脏停搏和切除自身瓣膜后植入瓣膜。无需进行植入缝合。通过短暂的低压球囊扩张实现最佳的瓣环密封。如果需要进行冠状动脉搭桥术，则首先进行远端吻合。在2007年4月至2008年2月期间，30例患者（平均年龄：81±4岁）接受了主动脉瓣置换术。单纯主动脉瓣狭窄的患病率为76.7%，混合病变的患病率为23.3%。平均逻辑欧洲心脏手术风险评估系统（EuroSCORE）为13.18%，纽约心脏协会（NYHA）心功能分级III级和IV级的患者分别占93.3%和6.7%。分别有37%和63%的患者植入的瓣膜尺寸为21mm和23mm，14例（46.7%）患者接受了冠状动脉旁路移植术（11例使用乳内动脉，9例使用静脉移植物）。
平均主动脉交叉钳夹时间和ECC时间分别为34±15分钟和59±21分钟。有1例住院死亡（3.3%），随访12个月内有3例死亡（1例死亡与瓣膜相关，2例死亡与瓣膜植入无关）。共对28例患者在植入后1个月进行了评估，23例在12个月后进行了评估。瓣膜未发生移位或脱落，但有2例轻度瓣周漏和2例轻度瓣内关闭不全。
该试验的初步结果证实了Perceval S无缝合主动脉瓣膜的安全性和有效性。在这一高风险患者亚组中，缩短主动脉交叉钳夹时间和ECC时间可能有助于降低死亡率和发病率。
