Health Economics and Outcomes Research (HEOR), Medtronic, Inc, Mounds View, MN, USA.
Global Patient Outcomes and Real-World Evidence, Eli Lilly and Co, Indianapolis, IN, USA.
J Med Econ. 2020 Jul;23(7):698-705. doi: 10.1080/13696998.2020.1751649. Epub 2020 Apr 22.
Cardiac device infections (CDIs) are serious adverse events associated with morbidity and mortality, significant costs and increased healthcare utilization. The objective of the current study was to characterize the CDI rate by device type, risk factors for infection and healthcare costs from a large U.S. health insurer perspective. A retrospective analysis of a large U.S. health insurer database identified commercial and Medicare Advantage with Part D (MAPD) members ≥18 years with ≥1 claim for a cardiac implantable electronic device (CIED) procedure between 01 October 2011 and 31 October 2015. CIEDs included pacemakers (IPG), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy - pacemakers without (CRT-P) and with defibrillation (CRT-D). Probabilities of CDI through one-year post implant were estimated using the Kaplan-Meier method. A regression model with stepwise variable selection was used to select risk factors associated with CDIs. A total of 63,406 patients were included with an overall CDI rate of 1.28% (1.0% de novo and 1.74% replacement devices), varying by device type: IPG = 0.91%; ICD = 1.63%; CRT- = 1.50%; CRT- = 2.22%. The average adjusted annual medical costs were 2.4 times greater [95% confidence interval (CI) = 2.1-2.7] for those with an infection compared to those without, and the incremental cost difference was estimated to be $57,322 [95% CI $46,572-$70,484]. Observed risk factors of CDIs included prior device infection [Odds ratio (OR) = 11.356; 95% CI = 7.923-16.276], undergoing a CIED replacement procedure (OR = 1.644; 95% CI = 1.361-1.987), implantation of a high-power device (OR = 1.354; 95% CI = 1.115-1.643), and younger age (age < 65) (OR = 1.607; 95% CI = 1.307-1.976). The CDI rate at one year ranged from 0.91%-2.22% depending on device type. Management of CDIs among commercial and MAPD members is associated with high healthcare expenditures.
心脏器械感染 (CDI) 是与发病率和死亡率、重大成本以及增加的医疗保健利用相关的严重不良事件。本研究的目的是从大型美国健康保险公司的角度描述按器械类型、感染风险因素和医疗保健成本分类的 CDI 发生率。对大型美国健康保险公司数据库进行的回顾性分析，确定了在 2011 年 10 月 1 日至 2015 年 10 月 31 日期间，商业和 Medicare Advantage with Part D (MAPD) 成员中年龄≥18 岁且至少有 1 次心脏植入式电子器械 (CIED) 程序索赔的成员。CIED 包括起搏器 (IPG)、植入式心律转复除颤器 (ICD)、心脏再同步治疗-不带除颤器的起搏器 (CRT-P) 和带除颤器的心脏再同步治疗起搏器 (CRT-D)。使用 Kaplan-Meier 方法估计植入后一年的 CDI 概率。使用逐步变量选择的回归模型选择与 CDI 相关的风险因素。共纳入 63406 例患者，总体 CDI 发生率为 1.28%（1.0%为新发病例，1.74%为更换器械），因器械类型而异：IPG=0.91%；ICD=1.63%；CRT-=1.50%；CRT-=2.22%。与无感染的患者相比，感染患者的平均年度医疗费用调整后增加了 2.4 倍[95%置信区间 (CI)=2.1-2.7]，增量成本差异估计为 57322 美元[95%CI 46572-70484]。CDI 的观察到的风险因素包括先前的器械感染[比值比 (OR)=11.356；95%CI=7.923-16.276]、接受 CIED 更换程序 (OR=1.644；95%CI=1.361-1.987)、植入高功率器械 (OR=1.354；95%CI=1.115-1.643) 和年龄较小 (年龄<65 岁)(OR=1.607；95%CI=1.307-1.976)。根据器械类型，一年后的 CDI 发生率在 0.91%-2.22%之间。商业和 MAPD 成员的 CDI 管理与高医疗保健支出相关。
