美敦力 Sprint Fidelis 导联召回：确定医疗保险最初 5 年的管理成本。
Medtronic Sprint Fidelis lead recall: determining the initial 5-year management cost to Medicare.
机构信息
Heart Rhythm Center in the Section of Cardiology, Department of Internal Medicine, University of Chicago, Chicago, Illinois, USA.
出版信息
Heart Rhythm. 2011 Aug;8(8):1192-7. doi: 10.1016/j.hrthm.2011.02.039. Epub 2011 Mar 3.
BACKGROUND
The Medtronic Sprint Fidelis defibrillator lead has a high failure rate and was recalled in October 2007.
OBJECTIVE
The purpose of this study was to determine the incremental cost of the management of this lead to Medicare.
METHODS
Real hospital cost data in U.S. dollars were collected on 32 patients with a Medtronic Sprint Fidelis lead who underwent lead revision. Of these patients, 15 were excluded because they had insurance coverage other than that provided by the Centers for Medicare & Medicaid Services. Seventeen patients with Medicare or Medicaid coverage underwent lead revision either electively (n = 6) or after being hospitalized for multiple shocks caused by a lead fracture (n = 11). Eighty-eight percent of the patients underwent extraction of the Fidelis lead at the time of lead revision. A decision model was made that outlines the potential management of the lead recall over time. The existing literature and Medtronic data were reviewed for parameters included in the decision model. The model assumed that 175,000 patients were alive with an implanted Fidelis lead at the time of the recall and that the annual failure rate will be 1.8% over the first 5 years. It was also assumed that 1% of patients without a lead fracture would also undergo elective lead revision each year and that the proportion of patients who would have the Fidelis lead extracted rather than abandoned would be 20:80. Estimates with ranges were used for parameters for which no data are available. The industry standard rate of lead failure was estimated based on the Sprint Quattro model 6947 lead, and this was subtracted from the estimated rates for the Sprint Fidelis lead such that the incremental cost of the lead failure could be estimated.
RESULTS
The cost of lead revision trended higher when the Fidelis lead was extracted rather than abandoned ($45,077 ± $11,693 vs $33,802 ± $33, P = .20). In 5 years, the estimated cost impact of the Medtronic Sprint Fidelis lead recall to Medicare will be $287,000,000 (range $176,000,000-$1,186,000,000, October 2007 USD).
CONCLUSION
The cost impact of managing a defibrillator lead with a high failure rate to Medicare will be substantial.
背景
美敦力 Sprint Fidelis 除颤器导联的故障率很高，并于 2007 年 10 月召回。
目的
本研究旨在确定管理 Medicare 中该导联的增量成本。
方法
以 32 名接受导联修正的美敦力 Sprint Fidelis 导联患者的实际医院成本数据为基础，以美元为单位进行收集。其中 15 名患者因保险范围与医疗保险和医疗补助服务中心提供的范围不同而被排除在外。17 名有医疗保险或医疗补助的患者因导联断裂导致多次电击而住院（n = 11）或选择（n = 6）进行导联修正。88%的患者在导联修正时同时进行 Fidelis 导联的提取。制作了一个决策模型，概述了随时间推移对导联召回的潜在管理。审查了现有文献和美敦力的数据，以确定决策模型中包含的参数。该模型假设在召回时，有 175,000 名患者植入 Fidelis 导联且在前 5 年内，每年的故障率将为 1.8%。还假设每年无导联断裂的 1%患者将接受选择性导联修正，且提取而非废弃 Fidelis 导联的患者比例将为 20:80。对于尚无数据的参数，使用了带有范围的估计值。根据 Sprint Quattro 模型 6947 导联，估计行业标准的导联故障率，并从 Sprint Fidelis 导联的估计率中减去，从而可以估计导联故障的增量成本。
结果
当 Fidelis 导联被提取而非废弃时，导联修正的成本呈上升趋势（$45,077 ± $11,693 比 $33,802 ± $33，P =.20）。在 5 年内，美敦力 Sprint Fidelis 导联召回对 Medicare 的估计成本影响将为 287,000,000 美元（2007 年 10 月美元，范围为 176,000,000 美元至 1,186,000,000 美元）。
结论
管理 Medicare 中高故障率的除颤器导联的成本影响将是巨大的。
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