Oertel Frank, Golczyk Karl, Pantele Sigrun, Danov Vladimir, Galiñanes Manuel, Beyer Michael
Heartcentre Augsburg, Augsburg, Germany.
J Cardiothorac Surg. 2012 Sep 4;7:82. doi: 10.1186/1749-8090-7-82.
Mitral Valve Repair (MVRP) has been shown to be significantly superior to Mitral Valve Replacement (MVR). Since the majority of repairs involve the Posterior Mitral Leaflet (PML) and not the Anterior Mitral Leaflet (AML), the monocuspidalisation of the Mitral Valve (MV) can be achieved with a bio-posterior leaflet that imitates a closed PML. This approach may have the benefit of restoring the competence of the MV without reducing its effective orifice area.
We have used a new concept and device, the MitroFixTM, to correct MV regurgitation due to pathology of the PML. The device comes with functional sizers both of which have identical shape and size. This allows the surgeon to pre-test the success of the restoration. From December 2006 to October 2011, 51 MitroFixTM devices were implanted at three institutions.
The mean age of the patients (32 males and 19 females) was 67.7 years. 37 of them were in NYHA class III or IV and all patients suffered from severe mitral valve regurgitation (MR). 31 patients underwent combined surgery. Successful implantation of the MitroFix™ device was performed in 51/53 patients.Mean cross-clamp time was 63.6 min (range: 29-118 min). Six patients had additional reconstructive procedures of the AML (chordae transfer, neo-chordae, triangular resection). At discharge, 33 patients showed no MR in the TTE and 17 patients exhibited trivial (I) or moderate (II) MR. The mean gradient was 4.0 mmHg and mean EOA was 2.52cm^2 (range: 1.5-4.0cm2). All patients were classified as being in NYHA class I or II.
The MitroFixTM Mitral Valve Restoration Device is a new concept that offers an effective treatment of MR. The restoration of the mitral valve with the MitroFix™ device offers the advantage of preserving the AML and providing good coaptation with a prosthetic PML. Importantly, this preliminary evaluation indicates a mean effective orifice area ( EOA ) of 2.5cm2 in MV receiving a MitroFix™ device, witch is higher than EOA resulting from MVR or MVRP. The present study has also shown that severe regurgitation due to ischemic/rheumatic MR, endocarditis and complex prolapse of the PML are clear candidates for correction with the MitroFix™. Larger studies and a longer follow up period are needed to validate these promising results.
二尖瓣修复术（MVRP）已被证明明显优于二尖瓣置换术（MVR）。由于大多数修复涉及二尖瓣后叶（PML）而非前叶（AML），使用模仿闭合PML的生物后叶可实现二尖瓣（MV）的单瓣化。这种方法可能有助于恢复MV的功能，同时不减小其有效瓣口面积。
我们使用了一种新的概念和装置——MitroFixTM，来纠正因PML病变导致的MV反流。该装置配有功能尺寸测量器，二者形状和大小相同。这使外科医生能够预先测试修复的成功率。2006年12月至2011年10月，在三个机构植入了51个MitroFixTM装置。
患者平均年龄67.7岁（男性32例，女性19例）。其中37例为纽约心脏协会（NYHA）心功能III级或IV级，所有患者均患有严重二尖瓣反流（MR）。31例患者接受了联合手术。51/53例患者成功植入MitroFix™装置。平均体外循环时间为63.6分钟（范围：29 - 118分钟）。6例患者对AML进行了额外的重建手术（腱索转移、人工腱索、三角形切除）。出院时，33例患者经经胸超声心动图（TTE）检查无MR，17例患者有轻微（I级）或中度（II级）MR。平均压差为4.0 mmHg，平均有效瓣口面积（EOA）为2.52cm²（范围：1.5 - 4.0cm²）。所有患者均被归类为NYHA心功能I级或II级。
MitroFixTM二尖瓣修复装置是一种提供有效治疗MR的新概念。使用MitroFix™装置修复二尖瓣具有保留AML并与人工PML良好贴合的优势。重要的是，该初步评估表明接受MitroFix™装置的MV平均有效瓣口面积（EOA）为2.5cm²，高于MVR或MVRP后的EOA。本研究还表明，MitroFix™可明确用于纠正缺血性/风湿性MR、心内膜炎及PML复杂脱垂导致的严重反流。需要更大规模的研究和更长的随访期来验证这些有前景的结果。
