Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Quebec, Canada.
Am Heart J. 2013 May;165(5):761-9. doi: 10.1016/j.ahj.2013.01.010. Epub 2013 Feb 14.
PTOLEMY-2 was a prospective multicenter phase I single-arm feasibility trial to evaluate the second-generation permanent percutaneous transvenous mitral annuloplasty (PTMA) device in reducing functional mitral regurgitation (MR).
Percutaneous MR reduction has been performed through a direct method of clipping and securing the mitral leaflets together or an indirect approach of reducing mitral annular dimension via the coronary sinus. The PTMA device is the only coronary sinus mitral repair device without a static fixation element.
Patients with at least moderate functional MR, New York Heart Association functional class II to IV, and left ventricular ejection fraction of 20% to 50% were enrolled at 14 centers in 5 countries. Device effects on patients were assessed by serial echocardiography, quality of life (QOL), and exercise capacity metrics.
A total of 43 patients were recruited, and 30 patients (70%) were implanted with a permanent PTMA device with a mean follow-up of 5.8 ± 3.8 months. The primary safety end point (freedom from death, myocardial infarction, stroke, or emergency surgery) at 30 days was met in 28 patients, whereas 2 patients died of device-related complications. The primary efficacy end point (MR reduction of at least 1.0 grade or reduction of regurgitant orifice area by 0.1 cm(2) or regurgitant volume by 15 mL or regurgitant fraction by 10% compared with baseline) was obtained in 13 patients. No significant changes were noted in MR parameters, ventricular volumes, or QOL. Distance walked on 6 minutes testing at 6-month follow-up increased from 331 ± 167 m to 417 ± 132 m (P = .65). Compared with nonresponders, responders had a higher baseline regurgitant orifice area >0.2 cm(2) (P = .001) and less prior history of myocardial infarction (P = .02), coronary artery bypass surgery (P = .03), and ischemic MR (P = .04).
Overall, PTMA had mild impact on MR reduction, left ventricular remodeling, QOL, and exercise capacity. During follow-up, the risk/benefit ratio remained suboptimal.
PTOLEMY-2 是一项前瞻性、多中心、单臂可行性试验，旨在评估第二代永久性经皮经静脉二尖瓣环成形术（PTMA）装置在减少功能性二尖瓣反流（MR）中的作用。
经皮 MR 减少已经通过直接方法（夹闭并固定二尖瓣叶）或间接方法（通过冠状窦减少二尖瓣环尺寸）进行。PTMA 装置是唯一没有静态固定元件的冠状窦二尖瓣修复装置。
在 5 个国家的 14 个中心招募至少有中度功能性 MR、纽约心脏协会功能分级 II 至 IV 级和左心室射血分数为 20%至 50%的患者。通过连续超声心动图、生活质量（QOL）和运动能力指标评估器械对患者的影响。
共招募了 43 名患者，其中 30 名（70%）患者植入永久性 PTMA 装置，平均随访 5.8±3.8 个月。30 天的主要安全性终点（无死亡、心肌梗死、中风或急诊手术）在 28 名患者中得到满足，而 2 名患者因器械相关并发症死亡。主要疗效终点（MR 减少至少 1.0 级或反流口面积减少 0.1cm²或反流量减少 15ml 或反流分数减少 10%与基线相比）在 13 名患者中获得。MR 参数、心室容积或 QOL 无明显变化。6 个月随访时 6 分钟步行测试的距离从 331±167m 增加到 417±132m（P=0.65）。与无反应者相比，反应者的基线反流口面积>0.2cm²（P=0.001）和既往心肌梗死史（P=0.02）、冠状动脉旁路移植术（P=0.03）和缺血性 MR（P=0.04）较少。
总体而言，PTMA 对 MR 减少、左心室重构、QOL 和运动能力的影响较小。在随访期间，风险/获益比仍然不理想。
