Implantable cardioverter-defibrillator FDA safety advisories: Impact on patient mortality and morbidity.
Implantable cardioverter-defibrillator FDA safety advisories: Impact on patient mortality and morbidity.
复制标题
植入式心律转复除颤器 FDA 安全建议：对患者死亡率和发病率的影响。
DOI：
10.1016/j.hrthm.2012.07.002
复制
发表时间：
2012
期刊：
影响因子：
5.5
通讯作者：
Bh
中科院分区：
文献类型：
--
作者：
Sengupta,Jay;Kendig,ArthurC;Goormastic,Marlene;Hwang,Eui-Seock;Ching,ElizabethA;Chung,Roy;Lindsay,BruceD;Tchou,PatrickJ;Wilkoff,BruceL;Niebauer,MarkJ;Martin,DavidO;Varma,Niraj;Wazni,Oussama;Saliba,Walid;Kanj,Mohamed;Bh
很大一部分植入式心律转复器（ICD）受到美国食品药品监督管理局（FDA）的限制。器械植入对死亡率或患者护理的影响尚不清楚。虽然估计风险的ICD发电机下咨询是低的，依赖于ICD治疗，以防止猝死证明评估的长期mortality. PROTETIVETo测试的FDA咨询状态与长期mortality.METHODSThe研究是一个回顾性的，单中心审查的临床结果，包括设备故障，在患者从植入到取出或死亡。确定了1996年8月至2004年5月期间在克利夫兰诊所首次植入ICD的患者，这些患者成为ICD发生器FDA认证的对象。在1644例接受首次ICD植入的连续患者中，704例（43%）成为FDA咨询的对象，其中172例（10.5%）为I类，532例（32.3%）为II类。在14.0%的I类和10.1%的II类患者中，ICD在咨询通知之前被停用。在接受咨询的ICD中，记录了28例（4.0%）咨询相关故障和15例非咨询相关故障。在平均70个月的随访中，814名患者死亡。Kaplan-Meier 5年生存率为65.6%，无、I类和II类乳腺癌患者的5年生存率分别为64.2%、61.1%和69.3%（P = 0.17）。咨询相关的故障影响了联合咨询小组中的4%。基于保守的管理策略，在显著疾病相关死亡率的背景下，咨询下的ICD与死亡率增加无关。
BACKGROUNDA significant proportion of implantable cardioverter-defibrillators (ICDs) have been subject to Food and Drug Administration (FDA) advisories. The impact of device advisories on mortality or patient care is poorly understood. Although estimated risks of ICD generators under advisory are low, dependency on ICD therapies to prevent sudden death justifies the assessment of long-term mortality.OBJECTIVETo test the association of FDA advisory status with long-term mortality.METHODSThe study was a retrospective, single-center review of clinical outcomes, including device malfunctions, in patients from implantation to either explant or death. Patients with ICDs first implanted at Cleveland Clinic between August 1996 and May 2004 who became subject to FDA advisories on ICD generators were identified. Mortality was determined by using the Social Security Death Index.RESULTSIn 1644 consecutive patients receiving first ICD implants, 704 (43%) became subject to an FDA advisory, of which 172 (10.5%) were class I and 532 (32.3%) were class II. ICDs were explanted before advisory notifications in 14.0% of class I and 10.1% of class II advisories. Among ICDs under advisory, 28 (4.0%) advisory-related and 15 non–advisory- related malfunctions were documented. Over a median follow-up of 70 months, 814 patients died. Kaplan-Meier 5-year survival rate was 65.6% overall, and 64.2, 61.1, and 69.3% in patients with no, class I, and class II advisories, respectively (P = .17).CONCLUSIONSICD advisories impacted 43% of the patients. Advisory-related malfunctions affected 4% within the combined advisory group. Based on a conservative management strategy, ICDs under advisory were not associated with increased mortality over a background of significant disease-related mortality.
登录
查看更多内容
影响因子：
120.7
作者：
Gould, PA;Krahn, AD
通讯作者：
Krahn, AD
影响因子：
120.7
作者：
Maisel, WH;Sweeney, MO;Epstein, LM
通讯作者：
Epstein, LM
影响因子：
5.5
作者：
Hauser, Robert G.;Hayes, David L.;Tyers, G. Frank O.
通讯作者：
Tyers, G. Frank O.
影响因子：
5.5
作者：
Carlson, Mark D.;Wilkoff, Bruce L.;Zipes, Douglas P.
通讯作者：
Zipes, Douglas P.
起搏器和 ICD 故障——一幅不完整的图景。
DOI：
10.1001/jama.295.16.1944
发表时间：
2006
期刊：
JAMA
影响因子：
--
作者：
B. Wilkoff
通讯作者：
B. Wilkoff