Haaverstad Rune, Vitale Nicola, Karevold Asbjørn, Cappabianca Giangiuseppe, Tromsdal Arve, Olsen Peter Skov, Köber Lars, Ihlen Halfdan, Rein Kjell Arne, Svennevig Jan L
Department of Cardiothoracic Surgery, Trondheim University Hospital, Trondheim, Norway.
Heart. 2007 Apr;93(4):500-5. doi: 10.1136/hrt.2005.086041. Epub 2006 Oct 25.
The aim of this report is the prospective, multicentre evaluation of clinical results and haemodynamic performance of the Medtronic Advantage aortic valve prosthesis.
From April 2001 to June 2003, 166 patients (male:female 125:41; mean (SD) age 61.8 (11.8) years) received an aortic advantage valve prosthesis. Complete cumulative follow-up was 242.7 patient-years (maximum 3.2; mean 1.6 years). Postoperatively, patients underwent early (within 30 days) and 1 year transthoracic echocardiography.
30 day mortality was 2.4% (n = 4). Kaplan-Meier estimates of freedom from complications and linearised rates were as follows: 96.9 (1.6)% survival; 94.7 (1.3)% (2.06 patients/year) thrombo-embolism; 99.4 (0.6)% (0.4 patients/year) bleeding; 98.8 (0.9)% (0.8 patients/year) non-structural valve dysfunction; 98.8 (0.9)% (0.8 patients/year) reoperation. Valvular mean pressure gradients ranged from 16 (3) mm Hg for size 19 to 7 (2) mm Hg for size 27 and the corresponding effective orifice areas ranged from 1.2 (0.25) to 3.2 (0.66) cm(2). In all, left ventricular mass significantly decreased (p<0.001) and fractional shortening increased (p<0.001) from postoperative to 1 year echocardiography.
Haemodynamic performance and early clinical results of Medtronic advantage in the aortic position were satisfactory and comparable with those of other bileaflet valves in current clinical use.
本报告旨在对美敦力优势主动脉瓣膜假体的临床结果和血流动力学性能进行前瞻性多中心评估。
2001年4月至2003年6月，166例患者（男∶女为125∶41；平均（标准差）年龄61.8（11.8）岁）接受了主动脉优势瓣膜假体植入。完整的累积随访时间为242.7患者年（最长3.2年；平均1.6年）。术后，患者在术后早期（30天内）和1年时接受经胸超声心动图检查。
30天死亡率为2.4%（n = 4）。采用Kaplan-Meier法估计的无并发症生存率和线性化发生率如下：生存率为96.9（1.6）%；血栓栓塞发生率为94.7（1.3）%（每年2.06例患者）；出血发生率为99.4（0.6）%（每年0.4例患者）；非结构性瓣膜功能障碍发生率为98.8（0.9）%（每年0.8例患者）；再次手术发生率为98.8（0.9）%（每年0.8例患者）。瓣膜平均压力阶差范围为：19号瓣膜为16（3）mmHg，27号瓣膜为7（2）mmHg，相应的有效瓣口面积范围为1.2（0.25）至3.2（0.66）cm²。总体而言，从术后到1年超声心动图检查时，左心室质量显著降低（p<0.001），缩短分数增加（p<0.001）。
美敦力优势主动脉瓣膜在血流动力学性能和早期临床结果方面令人满意，与目前临床使用的其他双叶瓣膜相当。
