前瞻性随机评估左心室辅助装置患者植入式心脏复律除颤器的程控。
Prospective Randomized Evaluation of Implantable Cardioverter-Defibrillator Programming in Patients With a Left Ventricular Assist Device.
机构信息
Arrhythmia and Electrophysiology, Vanderbilt Heart and Vascular Institute, Nashville, TN.
University Centre, St. George's University School of Medicine, Grenada, West Indies.
出版信息
J Am Heart Assoc. 2018 Feb 23;7(5):e007748. doi: 10.1161/JAHA.117.007748.
BACKGROUND
Ventricular arrhythmias are common in patients with left ventricular assist devices (LVADs) but are often hemodynamically tolerated. Optimal implantable cardioverter defibrillator (ICD) tachy-programming strategies in patients with LVAD have not been determined. We sought to determine if an ultra-conservative ICD programming strategy in patients with LVAD affects ICD shocks.
METHODS AND RESULTS
Adult patients with an existing ICD undergoing continuous flow LVAD implantation were randomized to standard ICD programming by their treating physician or an ultra-conservative ICD programming strategy utilizing maximal allowable intervals to detection in the ventricular fibrillation and ventricular tachycardia zones with use of ATP. Patients with cardiac resynchronization therapy (CRT) devices were also randomized to CRT ON or OFF. Patients were followed a minimum of 6 months. The primary outcome was time to first ICD shock. Among the 83 patients studied, we found no statistically significant difference in time to first ICD shock or total ICD shocks between groups. In the ultra-conservative group 16% of patients experienced at least one shock compared with 21% in the control group (=0.66). There was no difference in mortality, arrhythmic hospitalization, or hospitalization for heart failure. In the 41 patients with CRT ICDs fewer shocks were observed with CRT-ON but this was not statistically significant: 10% of patients with CRT-ON (n=21) versus 38% with CRT-OFF (n=20) received shocks (=0.08).
CONCLUSIONS
An ultra-conservative programming strategy did not reduce ICD shocks. Programming restrictions on ventricular tachycardia and ventricular fibrillation zone therapy should be reconsidered for the LVAD population. The role of CRT in patients with LVAD warrants further investigation.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01977703.
背景
左心室辅助装置（LVAD）患者常发生室性心律失常，但通常能耐受血流动力学。尚未确定 LVAD 患者最优的植入式心脏复律除颤器（ICD）超速起搏策略。我们旨在确定 LVAD 患者采用超保守的 ICD 程控策略是否会影响 ICD 电击。
方法和结果
接受连续血流 LVAD 植入的成年患者，根据其治疗医师的方案进行标准 ICD 程控或采用超保守 ICD 程控策略，即利用 ATP 将室颤和室性心动过速区的检测最大允许间期最大化。心脏再同步治疗（CRT）装置的患者也随机分配到 CRT 开或关。患者随访至少 6 个月。主要结局为首次 ICD 电击时间。在 83 例研究患者中，我们发现两组之间首次 ICD 电击时间或总 ICD 电击次数无统计学差异。在超保守组中，16%的患者经历至少一次电击，而对照组为 21%（=0.66）。死亡率、心律失常住院率或心力衰竭住院率无差异。在 41 例 CRT ICD 患者中，CRT 开时观察到的电击次数更少，但无统计学差异：CRT 开（n=21）的患者中有 10%接受电击，而 CRT 关（n=20）的患者中有 38%接受电击（=0.08）。
结论
超保守的程控策略并未减少 ICD 电击。应重新考虑 LVAD 人群中对室性心动过速和室颤区治疗的程控限制。LVAD 患者 CRT 的作用需要进一步研究。
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