Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota 55905, USA.
J Am Coll Cardiol. 2011 Jul 12;58(3):278-83. doi: 10.1016/j.jacc.2011.03.027.
This study sought to compare all-cause mortality in patients with Fidelis leads (Medtronic, Minneapolis, Minnesota) to those with a nonadvisory lead.
Although Fidelis leads are prone to fracture, and rare deaths due to lead failure have been reported, it is unclear whether the presence of a Fidelis lead is associated with increased mortality. This study compares all-cause mortality in a large cohort of patients with Fidelis and Quattro implantable cardioverter-defibrillator (ICD) leads.
All patients with Fidelis (Medtronic models 6931, 6948, and 6949) and Quattro (Medtronic model 6947) leads followed at 3 tertiary care centers were identified from the medical records (implant dates: November 19, 2001, to December 23, 2008). Clinical and device-specific data were collected into a common database. Deaths were identified from medical records and the Social Security Death Index. Survival was estimated using the Kaplan-Meier method.
A total of 2,671 patients (1,030 Fidelis and 1,641 Quattro) were identified. There were 398 deaths: 147 in the Fidelis group (mean follow-up: 34.4 months) and 251 in the Quattro group (mean follow-up: 39.9 months). No deaths were associated with 85 Fidelis and 23 Quattro failures. At 4 years, survival was diminished in patients with Fidelis compared with Quattro leads (80.7% vs. 83.9%, p = 0.025). After adjustment for factors associated with mortality, survival was similar between groups. One hundred percent pacing was not associated with mortality. Elective removal of nonfailed leads was performed in 5.1% of Fidelis and 0.9% of Quattro patients.
In a conservatively managed cohort, in whom observation was predominantly utilized, adjusted survival is similar between patients with Fidelis and Quattro ICD leads.
本研究旨在比较 Fidelis 导联（美敦力，明尼苏达州明尼阿波利斯）和非建议导联患者的全因死亡率。
尽管 Fidelis 导联易发生断裂，且已有罕见因导联故障导致的死亡报告，但目前尚不清楚 Fidelis 导联的存在是否与死亡率升高相关。本研究比较了大量接受 Fidelis 和 Quattro 植入式心脏复律除颤器（ICD）导联治疗的患者的全因死亡率。
从医疗记录中确定了在 3 家三级护理中心接受 Fidelis（美敦力型号 6931、6948 和 6949）和 Quattro（美敦力型号 6947）导联治疗的所有患者（植入日期：2001 年 11 月 19 日至 2008 年 12 月 23 日）。收集临床和设备特定数据到一个共同的数据库中。从医疗记录和社会安全死亡索引中确定死亡人数。使用 Kaplan-Meier 方法估计生存情况。
共确定了 2671 名患者（1030 名 Fidelis 和 1641 名 Quattro）。有 398 例死亡：Fidelis 组 147 例（平均随访 34.4 个月），Quattro 组 251 例（平均随访 39.9 个月）。85 个 Fidelis 和 23 个 Quattro 故障没有导致死亡。4 年后，Fidelis 导联患者的生存率低于 Quattro 导联（80.7%对 83.9%，p=0.025）。调整与死亡率相关的因素后，两组之间的生存率相似。100%起搏与死亡率无关。Fidelis 患者中有 5.1%和 Quattro 患者中有 0.9%行非故障导联的选择性去除。
在保守管理的队列中，观察主要用于治疗，Fidelis 和 Quattro ICD 导联患者的调整后生存率相似。
