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从使用新一代植入式心脏复律除颤器的多中心临床试验中的数据记录中吸取的经验教训。监护人ATP 4210多中心研究小组。

Lessons learned from data logging in a multicenter clinical trial using a late-generation implantable cardioverter-defibrillator. The Guardian ATP 4210 Multicenter Investigators Group.

作者信息

Wood M A, Stambler B S, Damiano R J, Greenway P, Ellenbogen K A

机构信息

Medical College of Virginia, Richmond 23298.

出版信息

J Am Coll Cardiol. 1994 Dec;24(7):1692-9. doi: 10.1016/0735-1097(94)90176-7.

DOI:10.1016/0735-1097(94)90176-7
PMID:7963117
Abstract

OBJECTIVES

This study examined patterns of implantable cardioverter-defibrillator use as documented by data logging.

BACKGROUND

Implantable cardioverter-defibrillators are accepted therapy for malignant ventricular tachyarrhythmias; however, relatively little is known about their patterns of use. Incorporation of data-storage capacities into these devices provides insight into long-term defibrillator function.

METHODS

Stored data-logging information was retrieved from 401 implanted cardioverter-defibrillators in 393 patients over an average of 303 days of follow-up.

RESULTS

A total of 91,443 detections were recorded in 299 patients. One hundred-six patients (26%) had detections due to supraventricular tachycardias, electrical noise or other causes, resulting in inappropriate therapy delivery to 92 patients (23%). Two hundred eighty-one patients recorded 66,276 episodes of ventricular tachycardia or ventricular fibrillation. Of these, 74.4% episodes terminated spontaneously without any delivered therapy, 22.1% terminated after antitachycardia pacing, and 1.7% terminated after shock therapy. Antitachycardia pacing was activated without formal testing in 47% of all patients receiving this therapy and was successful in 96% of all episodes receiving this therapy. Acceleration of tachycardia to shock therapy occurred in 1.3% of all episodes and in 30.5% of patients receiving antitachycardia pacing. Thirty-four patients (8.7%) died during follow-up. Mortality was associated with patient age, heart failure functional class at implantation and frequency of shocks received during follow-up (all p < or = 0.05).

CONCLUSIONS

Most ventricular tachyarrhythmia detections by this noncommitted implantable cardioverter-defibrillator resolve spontaneously, whereas the majority receiving therapy can be treated with antitachycardia pacing. Mortality after implantable cardioverter-defibrillator implantation is associated with age, heart failure class and frequency of shocks received during follow-up. Data-logging capabilities provide valuable insights into the patterns of defibrillator use.

摘要

目的

本研究通过数据记录来检查植入式心脏复律除颤器的使用模式。

背景

植入式心脏复律除颤器是治疗恶性室性快速心律失常的公认疗法;然而,人们对其使用模式了解相对较少。将数据存储功能整合到这些设备中可深入了解除颤器的长期功能。

方法

在平均303天的随访期内,从393例患者的401台植入式心脏复律除颤器中检索存储的数据记录信息。

结果

299例患者共记录到91443次检测。106例患者(26%)因室上性心动过速、电噪声或其他原因出现检测结果,导致92例患者(23%)接受了不适当的治疗。281例患者记录到66276次室性心动过速或心室颤动发作。其中,74.4%的发作自行终止,未接受任何治疗;22.1%在抗心动过速起搏后终止;1.7%在电击治疗后终止。在所有接受该治疗的患者中,47%在未进行正式测试的情况下激活了抗心动过速起搏,且在所有接受该治疗的发作中,96%成功。在所有发作中,1.3%的发作以及接受抗心动过速起搏的患者中30.5%的发作,心动过速加速至电击治疗。34例患者(8.7%)在随访期间死亡。死亡率与患者年龄、植入时的心力衰竭功能分级以及随访期间接受电击的频率相关(均p≤0.05)。

结论

这种非专用植入式心脏复律除颤器检测到的大多数室性快速心律失常发作会自行缓解,而大多数接受治疗的患者可用抗心动过速起搏进行治疗。植入式心脏复律除颤器植入后的死亡率与年龄、心力衰竭分级以及随访期间接受电击的频率相关。数据记录功能为除颤器的使用模式提供了有价值的见解。

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