Gras D, Böcker D, Lunati M, Wellens H J J, Calvert M, Freemantle N, Gervais R, Kappenberger L, Tavazzi L, Erdmann E, Cleland J G F, Daubert J-C
Nouvelles Cliniques Nantaises, Nantes, France.
Europace. 2007 Jul;9(7):516-22. doi: 10.1093/europace/eum080. Epub 2007 May 31.
To assess procedural characteristics and adjudicated procedure-related (<or=30 days) major adverse events among patients who underwent cardiac resynchronization therapy (CRT) implantation in the CARE-HF study. The CARE-HF study shows that CRT improves symptoms and reduces morbidity and mortality in New York Heart Association (NYHA) class III/IV chronic heart failure (CHF) patients. However, safe and proper implantation of pacing systems remains key to effective CRT delivery.
Generalized linear modeling was used to examine the relationships between first implant success/failure and: NYHA class; beta-adrenergic blocker use; underlying ischemic vs. non-ischemic heart disease; history of coronary artery bypass graft or valve surgery; left ventricular (LV) end-diastolic volume<or=vs. >300 cm(3); and, influence of the participating study-centres. Implantation was attempted in 404/409 patients assigned to CRT, and in 65/404 patients assigned to medical therapy. Among these 469 patients, 450 (95.9%) received a successfully implanted and activated device. Complications occurred within 24 h in 47 patients (10.0%), mainly lead dislodgments (n = 10, 2.1%) and coronary sinus dissection/perforation (n = 10, 2.1%), and between 24 h and 30 days in 26 patients (5.5%), mainly lead dislodgment (n = 13, 2.8%). Mean LV lead stimulation threshold was significantly higher than at the right atrium or right ventricle, though remained stable, delivering effective, and reliable CRT. Implanting experience was the only predictor of procedural outcome.
Transvenous CRT system implantation, using a CS lead designed for long-term LV pacing, was safe and reliable. As implanting centres become more experienced, this success rate is expected to increase further.
在CARE-HF研究中，评估接受心脏再同步治疗（CRT）植入的患者的手术特征以及判定的与手术相关的（≤30天）主要不良事件。CARE-HF研究表明，CRT可改善纽约心脏协会（NYHA）III/IV级慢性心力衰竭（CHF）患者的症状，并降低发病率和死亡率。然而，安全且正确地植入起搏系统仍然是有效实施CRT的关键。
采用广义线性模型来研究首次植入成功/失败与以下因素之间的关系：NYHA分级；β-肾上腺素能阻滞剂的使用；潜在的缺血性与非缺血性心脏病；冠状动脉搭桥术或瓣膜手术史；左心室（LV）舒张末期容积≤300 cm³与＞300 cm³；以及参与研究中心的影响。404/409例分配接受CRT的患者和65/404例分配接受药物治疗的患者尝试进行植入。在这469例患者中，450例（95.9%）成功植入并激活了设备。47例患者（10.0%）在24小时内发生并发症，主要是导线脱位（n = 10，2.1%）和冠状窦夹层/穿孔（n = 10，2.1%），26例患者（5.5%）在24小时至30天之间发生并发症，主要是导线脱位（n = 13，2.8%）。左心室导线刺激阈值显著高于右心房或右心室，尽管保持稳定，可提供有效且可靠的CRT。植入经验是手术结果的唯一预测因素。
使用专为长期左心室起搏设计的冠状窦导线进行经静脉CRT系统植入是安全可靠的。随着植入中心经验的增加，预计成功率会进一步提高。
