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心脏再同步化治疗除颤器(CRT-D)与植入式心律转复除颤器(ICD)患者中新型 ICD 程控与不适当 ICD 治疗:MADIT-RIT 子研究。

Novel ICD Programming and Inappropriate ICD Therapy in CRT-D Versus ICD Patients: A MADIT-RIT Sub-Study.

机构信息

From the University of Rochester Medical Center, Heart Research Follow-Up Program, Rochester, NY (V.K., I.G., H.K., M.K.A., S.M., W.Z., A.J.M.); Duke University Medical Center, Division of Cardiology, Durham, NC (J.P.D.); Henry Ford Hospital, Detroit, MI (C.S.); Experimental and Clinical Research Center, a Joint Cooperation between the Charité Medical Faculty and the Max-Delbrueck Center for Molecular Medicine, Berlin, Germany (M.S.); and Semmelweis University, Heart and Vascular Center, Budapest, Hungary (B.M.).

出版信息

Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e001965. doi: 10.1161/CIRCEP.114.001965.

Abstract

BACKGROUND

The Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate therapy (MADIT-RIT) trial showed a significant reduction in inappropriate implantable cardioverter defibrillator (ICD) therapy in patients programmed to high-rate cut-off (Arm B) or delayed ventricular tachycardia therapy (Arm C), compared with conventional programming (Arm A). There is limited data on the effect of cardiac resynchronization therapy with a cardioverter defibrillator (CRT-D) on the effect of ICD programming. We aimed to elucidate the effect of CRT-D on ICD programming to reduce inappropriate ICD therapy in patients implanted with CRT-D or an ICD, enrolled in MADIT-RIT.

METHODS AND RESULTS

The primary end point of this study was the first inappropriate ICD therapy. Secondary end points were inappropriate anti-tachycardia pacing and inappropriate ICD shock. The study enrolled 742 (49%) patients with an ICD and 757 (51%) patients with a CRT-D. Patients implanted with a CRT-D had 62% lower risk of inappropriate ICD therapy than those with an ICD only (hazard ratio [HR] =0.38, 95% confidence interval: 0.25-0.57; P<0.001). High-rate cut-off or delayed ventricular tachycardia therapy programming significantly reduced the risk of inappropriate ICD therapy compared with conventional ICD programming in ICD (HR=0.14 [B versus A]; HR=0.21 [C versus A]) and CRT-D patients (HR=0.15 [B versus A]; HR=0.23 [C versus A]; P<0.001 for all). There was a significant reduction in inappropriate anti-tachycardia pacings in both group and a significant reduction in inappropriate ICD shock in CRT-D patients.

CONCLUSIONS

Patients implanted with a CRT-D have lower risk of inappropriate ICD therapy than those with an ICD. Innovative ICD programming significantly reduces the risk of inappropriate ICD therapy in both ICD and CRT-D patients.

CLINICAL TRIAL REGISTRATION

http://clinicaltrials.gov; Unique identifier: NCT00947310.

摘要

背景

多中心自动除颤器植入试验-降低不适当治疗(MADIT-RIT)试验表明,与传统编程(A 组)相比,程控为高心率截止(B 组)或延迟性室性心动过速治疗(C 组)的患者,植入式心脏复律除颤器(ICD)的不适当治疗显著减少。关于心脏再同步治疗除颤器(CRT-D)对 ICD 编程的影响,数据有限。我们旨在阐明 CRT-D 对 ICD 编程的影响,以降低 MADIT-RIT 中植入 CRT-D 或 ICD 的患者 ICD 治疗不适当的风险。

方法和结果

本研究的主要终点是首次 ICD 治疗不适当。次要终点为不适当的抗心动过速起搏和不适当的 ICD 电击。该研究共纳入 742 例(49%)植入 ICD 患者和 757 例(51%)植入 CRT-D 患者。与仅植入 ICD 的患者相比,植入 CRT-D 的患者 ICD 治疗不适当的风险降低了 62%(风险比[HR] =0.38,95%置信区间:0.25-0.57;P<0.001)。与传统 ICD 编程相比,高心率截止或延迟性室性心动过速治疗编程显著降低了 ICD(HR=0.14 [B 与 A];HR=0.21 [C 与 A])和 CRT-D 患者(HR=0.15 [B 与 A];HR=0.23 [C 与 A])的 ICD 治疗不适当的风险(所有 P<0.001)。两组患者的不适当抗心动过速起搏均显著减少,而 CRT-D 患者的 ICD 电击不适当也显著减少。

结论

植入 CRT-D 的患者 ICD 治疗不适当的风险低于植入 ICD 的患者。创新性的 ICD 编程显著降低了 ICD 和 CRT-D 患者 ICD 治疗不适当的风险。

临床试验注册

http://clinicaltrials.gov;唯一标识符:NCT00947310。

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