The Children's Hospital of Philadelphia, Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.
Ann Thorac Surg. 2012 Mar;93(3):783-8. doi: 10.1016/j.athoracsur.2011.12.021.
The recurrence of regurgitation after surgical mitral valve (MV) repair remains a significant clinical problem. Mitral annuloplasty rings are commonly used in MV repair procedures. The purpose of this study was to demonstrate the feasibility of transvenous valve-in-ring (VIR) implantation using the Melody valve (Medtronic, Minneapolis, MN), which is a valved-stent designed for percutaneous pulmonary valve replacement, and 4 distinct types of annuloplasty ring (AR) in an ovine model.
Ten sheep underwent surgical MV annuloplasty ring placement (n=10): CE-Physio, Edwards Lifesciences, Irvine, CA [n=5]; partial ring [n=3]; flexible ring [n=1]; and saddle ring [n=1]). All animals underwent cardiac catheterization, hemodynamic assessment, and Melody VIR implantation through a transfemoral venous, transatrial septal approach 1 week after surgery. Follow-up hemodynamic, angiographic, and echocardiographic data were recorded.
Melody VIR implantation was technically successful in all but 1 animal. In this animal a 26-mm partial AR proved too large for secure anchoring of the Melody valve. In the remaining 9 animals, fluoroscopy showed the Melody devices securely positioned within the annuloplasty rings. Echocardiography revealed no perivalvular leak, and angiography revealed no left ventricular outflow tract obstruction, vigorous left ventricular function, and no aortic valve insufficiency. The median procedure time was 55.5 (range, 45 to 78) minutes.
This study demonstrates the feasibility of a purely percutaneous approach to MV replacement in patients with preexisting annuloplasty rings, regardless of ring type. This approach may be of particular benefit to patients with failed repair of ischemic mitral regurgitation.
外科二尖瓣（MV）修复术后反流的复发仍然是一个重大的临床问题。二尖瓣瓣环成形环通常用于 MV 修复手术。本研究旨在证明使用 Melody 瓣膜（美敦力，明尼苏达州明尼阿波利斯）进行经静脉瓣环内（VIR）植入的可行性，该瓣膜是一种设计用于经皮肺动脉瓣置换的带瓣支架，以及在绵羊模型中使用 4 种不同类型的瓣环成形环（AR）。
10 只绵羊接受了 MV 瓣环成形环放置手术（n=10）：CE-Physio，爱德华生命科学公司，加利福尼亚州欧文[ n=5]；部分环[n=3]；柔性环[n=1]；和鞍形环[n=1]）。所有动物均在手术后 1 周接受了经股静脉、经房间隔的心脏导管插入术、血液动力学评估和 Melody VIR 植入术。记录随访的血液动力学、血管造影和超声心动图数据。
除了 1 只动物外，所有动物的 Melody VIR 植入均技术上成功。在这只动物中，26 毫米的部分 AR 太大，无法安全固定 Melody 瓣膜。在其余 9 只动物中，透视显示 Melody 装置牢固地位于瓣环成形环内。超声心动图未发现瓣周漏，血管造影未发现左心室流出道梗阻、左心室功能亢进和主动脉瓣关闭不全。中位手术时间为 55.5（范围 45 至 78）分钟。
这项研究证明了在存在预先存在的瓣环成形环的患者中，无论瓣环类型如何，采用纯粹经皮方法进行 MV 置换的可行性。这种方法对于缺血性二尖瓣反流修复失败的患者可能特别有益。
