San Raffaele University Hospital, Milan, Italy.
Eur J Cardiothorac Surg. 2013 Nov;44(5):913-8. doi: 10.1093/ejcts/ezt128. Epub 2013 Mar 25.
To evaluate the performance and safety of an adjustable semi-rigid annuloplasty ring for mitral regurgitation (MR) in a multicentre study.
Between March 2010 and December 2011, 30 subjects underwent mitral valve (MV) repair using the Cardinal adjustable annuloplasty ring. This device is a semi-rigid ring allowing postimplantation size adjustment, under beating-heart conditions, to optimize leaflet coaptation under echocardiographic guidance. Coaptation length was determined before and after adjustment by transoesophageal echocardiography.
The study enrolled 21 (70%) male and 9 (30%) female subjects with a mean age of 64 years. The approach was conventional midline sternotomy or mini-invasive right thoracotomy. Leaflet resection was done in 17 subjects, and chordal repair was used in 13. Concomitant procedures included coronary artery bypass grafting in 2 (7%) subjects, atrial ablation in 4 (13%) and tricuspid repair in 4 (13%). There was 1 (3%) early death unrelated to the study device. Intraoperative ring adjustment was performed in 24 of the 30 subjects. Residual MR was detected prior to adjustment in 6 subjects (4 mild and 2 moderate MR). Following adjustment, 5 subjects had no MR and 1 had trace MR. After adjustment, mean coaptation length improved from 7 ± 3 to 10 ± 3 mm (P < 0.0001). All patients who completed 1-year follow-up had less-than-mild MR, with the exception of 1 patient with ring dehiscence (and resultant 2+ MR) and 1 functional MR patient who developed recurrent 2+ MR due to persistent leaflet tethering.
MV repair with the Cardinal adjustable annuloplasty ring is a reliable technique that enables the adjustment of the ring diameter on a beating heart under echocardiographic control. Such technology allows the optimization of leaflet coaptation, providing minimal residual MR and durable repair.
在一项多中心研究中评估二尖瓣反流(MR)可调式半刚性瓣环成形术的疗效和安全性。
2010 年 3 月至 2011 年 12 月,30 例患者接受了二尖瓣(MV)修复手术,使用 Cardinal 可调瓣环。该装置是一种半刚性环,允许在心脏不停跳的情况下进行植入后尺寸调整,在超声心动图引导下优化瓣叶对合。通过经食管超声心动图在调整前后确定对合长度。
该研究纳入了 21 例(70%)男性和 9 例(30%)女性患者,平均年龄为 64 岁。手术入路为常规正中胸骨切开术或微创右胸切开术。17 例患者行瓣叶切除术,13 例患者行腱索修复术。同期手术包括 2 例(7%)患者冠状动脉旁路移植术、4 例(13%)患者心房消融术和 4 例(13%)患者三尖瓣修复术。1 例(3%)早期死亡与研究装置无关。30 例患者中有 24 例在术中进行了瓣环调整。在 6 例患者(4 例轻度 MR 和 2 例中度 MR)术前调整前检测到残余 MR。调整后,5 例患者无 MR,1 例患者为微量 MR。调整后,平均对合长度从 7±3mm 改善至 10±3mm(P<0.0001)。所有完成 1 年随访的患者均为轻度以下 MR,除 1 例瓣环裂开(并导致 2+MR)和 1 例因瓣叶持续牵拉导致复发性 2+MR 的功能性 MR 患者外。
使用 Cardinal 可调瓣环进行 MV 修复是一种可靠的技术,可在超声心动图控制下心脏不停跳时调整瓣环直径。该技术可优化瓣叶对合,提供最小残余 MR 和持久修复。