Wathen Mark
Vanderbilt University, Nashville, TN, USA.
Am Heart J. 2007 Apr;153(4 Suppl):44-52. doi: 10.1016/j.ahj.2007.01.020.
The main purpose of ICDs is to abort sudden death by delivering therapy at the moment of tachycardia. Shocks accomplish this goal but are painful. Alternatively antitachycardia pacing is painless and if deemed safe may be reasonable substitute. Multiple trials show a high efficacy rate by ATP (78-94%) for treating VTs below 200 bpm. ATP has had less efficacy for faster VTs (41-79%) and have higher probability of accelerating tachycardia (5-55%). The PainFREE trials address these issues. The first pilot study PainFREE Rx applied standardized VT detection and ATP regimen to 220 patients with 1100 spontaneous episodes of VT. ATP success for slow VT success was 92% and fast VT > 188 bpm raw success rate was 89%. None of these trials randomize shock versus ATP so comparative safety data was missing. Thus, the PainFREE Rx II trial was designed to make direct safety comparison between shock and ATP therapies for fast VT > 188 bpm. It included 634 patients with either ischemic or nonischemic cardiomyopathy followed for 1 year yielding 1760 episodes of slow VT, fast VT plus VF. The results of the PainFREE Rx II trial showed that a single regimen of ATP, burst pace 8 pulses at 88% VT cycle length could safely terminate 77% of fast VT and 90% of slow VT. Consequently, shocks were reduced by 70% compared to the shock group. Furthermore, ATP was proven safe because there was no increase in sudden death, syncope or even arrhythmia acceleration compared to shock. The quality of life of the ATP group was found to be superior to the shock group validating ATP's intent. Secondary yet important findings also included the fact that by programming the ICD to wait for 18 beats in PainFREE Rx II before treating an episode reduced markedly the number of episodes treated when compared to 12 beat detection as done in PainFREE Rx I. Since syncope occurred in only 1% of episodes, the authors suggested that a longer wait for ICD detection needs to be evaluated.
植入式心脏除颤器(ICD)的主要目的是在心动过速发作时通过提供治疗来中止猝死。电击可实现这一目标,但会带来疼痛。相比之下,抗心动过速起搏无痛,若被认为安全,则可能是合理的替代方法。多项试验表明,对于治疗每分钟心率低于200次的室性心动过速(VT),抗心动过速起搏(ATP)的有效率很高(78 - 94%)。对于更快的室性心动过速,ATP的疗效较低(41 - 79%),且加速心动过速的可能性更高(5 - 55%)。“无痛”试验解决了这些问题。首个试点研究“无痛治疗方案(PainFREE Rx)”对220名患者的1100次自发性室性心动过速发作应用了标准化的室性心动过速检测和抗心动过速起搏方案。对于缓慢的室性心动过速,抗心动过速起搏的成功率为92%,对于心率大于每分钟188次的快速室性心动过速,原始成功率为89%。这些试验均未对电击与抗心动过速起搏进行随机分组,因此缺少比较安全性数据。因此,“无痛治疗方案II(PainFREE Rx II)”试验旨在对心率大于每分钟188次的快速室性心动过速的电击疗法和抗心动过速起搏疗法进行直接安全性比较。该试验纳入了634名患有缺血性或非缺血性心肌病的患者,随访1年,共出现1760次缓慢室性心动过速、快速室性心动过速以及心室颤动发作。“无痛治疗方案II”试验的结果表明,单一的抗心动过速起搏方案,即按室性心动过速周期长度的88%发放8个脉冲的短阵起搏,可安全地终止77%的快速室性心动过速和90%的缓慢室性心动过速。因此,与电击组相比,电击次数减少了70%。此外,抗心动过速起搏被证明是安全的,因为与电击相比,猝死、晕厥甚至心律失常加速均未增加。结果发现,抗心动过速起搏组的生活质量优于电击组,证实了抗心动过速起搏的目的。次要但重要的数据还包括这样一个事实,即在“无痛治疗方案II”中,通过将植入式心脏除颤器设置为在治疗发作前等待18次心跳,与“无痛治疗方案I”中采用的12次心跳检测相比,显著减少了治疗的发作次数。由于晕厥仅发生在1%的发作中,作者建议需要评估植入式心脏除颤器更长的检测等待时间。