Klodell Charles T, Aranda Juan M, McGiffin David C, Rayburn Barry K, Sun Benjamin, Abraham William T, Pae Walter E, Boehmer John P, Klein Helmut, Huth Christof
Department of Surgery, Division of Thoracic and Cardiovascular Surgery, University of Florida College of Medicine, Gainesville, Fla 32610, USA.
J Thorac Cardiovasc Surg. 2008 Jan;135(1):188-95. doi: 10.1016/j.jtcvs.2007.09.034.
An elastic ventricular restraint device has been developed for patients with heart failure who remain symptomatic despite treatment with standard therapies. The safety and efficacy of this device are under clinical investigation. Six-month data for the first 51 patients treated worldwide are reported. We hypothesize that the Paracor HeartNet device (Paracor Medical, Sunnyvale, Calif), placed through a minithoracotomy in patients with severe dilated cardiomyopathy, improves clinical and functional status.
Fifty-one patients with an ejection fraction of 35% or less, with a New York Heart Association class II or III, and receiving optimal medical therapy for at least 3 months, were selected at 15 sites (3 in Europe, 12 in the United States) to undergo implantation of the HeartNet device through a minithoracotomy. Patients were evaluated at baseline and at 6-month follow-up by echocardiography, the 6-minute walk test, cardiopulmonary exercise testing (partial oxygen pressure in mixed venous blood), New York Heart Association class, and (in the United States) the Minnesota Living with Heart Failure questionnaire.
The average age was 52 years (30-73 years), with a preponderance of men and nonischemic cause of heart failure. Implantation was accomplished in 50 of 51 patients (98%). Adverse events included 2 in-hospital deaths secondary to pulmonary complications (4%), additional pulmonary complications in 7 patients (14%), arrhythmia in 14 patients (27%), epicardial laceration in 2 patients (4%), and empyema in 1 patient (2%). Six-month data demonstrated significant improvement in the 6-minute walk test (+65.7, P = .002) and Minnesota Living with Heart Failure scores (-15.7, P = .002) and improvement in echocardiographic findings.
The Paracor HeartNet device can be reliably implanted in patients with heart failure and marked reduction of left ventricular function. These data suggest a functional and clinical benefit, with a trend toward reverse remodeling, and support the conduct of a randomized controlled pivotal trial.
已为尽管接受标准治疗仍有症状的心力衰竭患者研发出一种弹性心室约束装置。该装置的安全性和有效性正在进行临床研究。本文报告了全球首批51例接受治疗患者的6个月数据。我们假设，通过小切口开胸术植入Paracor HeartNet装置（加利福尼亚州森尼韦尔市的Paracor Medical公司生产）可改善重度扩张型心肌病患者的临床和功能状态。
在15个地点（欧洲3个，美国12个）选取了51例射血分数为35%或更低、纽约心脏协会心功能分级为II级或III级且接受至少3个月最佳药物治疗的患者，通过小切口开胸术植入HeartNet装置。在基线和6个月随访时，通过超声心动图、6分钟步行试验、心肺运动试验（混合静脉血中的部分氧分压）、纽约心脏协会心功能分级以及（在美国）明尼苏达心力衰竭生活问卷对患者进行评估。
平均年龄为52岁（30 - 73岁），男性居多，心力衰竭病因以非缺血性为主。51例患者中有50例（98%）完成了植入。不良事件包括2例因肺部并发症导致的住院死亡（4%），7例患者出现额外的肺部并发症（14%），14例患者出现心律失常（27%），2例患者出现心外膜撕裂（4%），1例患者出现脓胸（2%）。6个月数据显示，6分钟步行试验有显著改善（增加65.7，P = .002），明尼苏达心力衰竭生活评分降低（降低15.7，P = .002），超声心动图检查结果也有所改善。
Paracor HeartNet装置能够可靠地植入心力衰竭且左心室功能显著降低的患者体内。这些数据表明该装置具有功能和临床益处，有逆向重构的趋势，并支持开展一项随机对照关键试验。
