Auricchio A, Stellbrink C, Sack S, Block M, Vogt J, Bakker P, Mortensen P, Klein H
Department of Cardiology, University Hospital, Magdeburg, Germany.
Am J Cardiol. 1999 Mar 11;83(5B):130D-135D. doi: 10.1016/s0002-9149(98)01014-5.
In conjunction with pharmacologic therapy, pacing has been proposed as a potential treatment to decrease symptoms in patients with moderate-to-severe congestive heart failure (CHF). Uncontrolled studies of pacing therapy for CHF dealing with different pacing sites, modes of pacing, and atrioventricular delays have reported mixed outcomes. The Pacing Therapies in Congestive Heart Failure (PATH-CHF) study is a single-blind, randomized, crossover, controlled trial designed to evaluate the effects of pacing on acute hemodynamic function and to assess chronic clinical benefit in patients with moderate-to-severe CHF. The effect of pacing on oxygen consumption at peak exercise and at anaerobic threshold during cardiopulmonary exercise tests, and on 6-minute walk distance, have been selected as primary endpoints of the study. Secondary endpoints of the trial were changes in New York Heart Association (NYHA) functional class, quality-of-life as assessed by the Minnesota Living with Heart Failure questionnaire, and hospitalization frequency. Finally, changes in ejection fraction, cardiac output, and filling pattern were assessed by echocardiography. The trial was planned to include 53 patients from 7 centers in Europe over a period of 3 years. The study was divided into 2 parts: acute testing and chronic follow-up. The acute study, performed during the pacemaker implantation, involved extensive testing using a custom-designed computer (FLEXSTIM) and a unique burst pacing protocol (FLEXSTIM protocol) to determine the best ventricular pacing sites and the most appropriate atrioventricular delays. The chronic phase consisted of a crossover study designed to test in each patient the best univentricular pacing site and biventricular pacing as assessed by the acute hemodynamic study. The study started with the first implant in 1995 and has, to date, included 42 patients. The study is expected to be completed by the end of 1998. The results of a first interim analysis showed trends toward improvement in all primary and secondary endpoints during the pacing periods compared with no pacing.
作为药物治疗的辅助手段，起搏已被提议作为一种潜在的治疗方法，用于减轻中重度充血性心力衰竭（CHF）患者的症状。针对CHF的起搏治疗，在不同起搏部位、起搏模式和房室延迟方面开展的非对照研究，报告的结果不一。充血性心力衰竭起搏治疗（PATH-CHF）研究是一项单盲、随机、交叉、对照试验，旨在评估起搏对急性血流动力学功能的影响，并评估中重度CHF患者的慢性临床获益。在心肺运动试验中，起搏对峰值运动时和无氧阈值时的耗氧量以及对6分钟步行距离的影响，已被选为该研究的主要终点。该试验的次要终点包括纽约心脏协会（NYHA）心功能分级的变化、通过明尼苏达心力衰竭生活问卷评估的生活质量以及住院频率。最后，通过超声心动图评估射血分数、心输出量和充盈模式的变化。该试验计划在3年内纳入来自欧洲7个中心的53名患者。该研究分为两部分：急性测试和慢性随访。急性研究在起搏器植入期间进行，涉及使用定制设计的计算机（FLEXSTIM）和独特的短阵猝发起搏方案（FLEXSTIM方案）进行广泛测试，以确定最佳心室起搏部位和最合适的房室延迟。慢性阶段包括一项交叉研究，旨在在每名患者中测试急性血流动力学研究评估出的最佳单心室起搏部位和双心室起搏。该研究于1995年首次植入起搏器开始，迄今为止已纳入42名患者。预计该研究将于1998年底完成。首次中期分析的结果显示，与不起搏相比，起搏期间所有主要和次要终点均有改善的趋势。
