植入埋藏式心脏复律除颤器的医疗保险受益者中严重并发症的发生率和治疗费用增加

Objectives: We aimed to quantify the frequency and nature of early complications after implantable cardioverter-defibrillator(ICD) implantation in general practice, and estimate the incremental costs of those complications to the health care system. Background: Cardioverter-defibrillator implantation rates are rising quickly. Little has been published regarding the outcomes and costs of these procedures in unselected populations. Methods: Using Medicare Provider Analysis and Review(MedPAR) files, we identified 30,984 admissions containing procedure codes for new ICD or cardiac resynchronization therapy defibrillator implantation in fiscal year 2003. The frequencies of eight complicating diagnoses during these admissions were determined. Length of stay(LOS) and total hospital costs, derived using whole-hospital cost to charge ratios, were calculated for each admission. The incremental effects of any and each complication on LOS and hospital cost were estimated in multivariable models, adjusting for demographic factors and comorbid conditions. Results: The mean cost for all admissions was ＄42,184(median ＄37,902) with mean LOS of 4.7 days(median 2.0 days). One or more complications were coded in 10.8%of admissions, most commonly “mechanical complication of the ICD”and hemorrhage/hematoma. The occurrence of any complication increased adjusted LOS by 3.4 days and costs by ＄7,251. Each of the individual complications was associated with highly significant increases in both LOS(1 to 10 days) and hospital cost(＄5,000 to ＄20,000). Conclusions: In fiscal 2003, 10.8%of Medicare patients undergoing cardioverter-defibrillator implantation experienced one or more early complications, associated with significant increases in LOS and costs. Efforts to reduce these complications could have significant clinical and financial benefits.

行隐静脉旁路搭桥的经皮介入治疗患者中远端血栓保护的成本效益:SAFER试验的结果

The goal of this research was to determine the incremental cost and cost-effectiveness of embolic protection in patients undergoing percutaneous revascularization (PCI) of diseased saphenous vein bypass grafts(SVGs). Distal protection using the GuardWire balloon occlusion device has been shown to reduce major ischemic complications in patients undergoing SVG PCI, but the cost-effectiveness of this approach is unknown. We prospectively measured medical resource utilization and cost for 801 patients undergoing SVG intervention who were randomized to distal protection using the GuardWire(n=406) or conventional treatment (n=395) in the Saphenous Vein Graft Angioplasty Free of Emboli Randomized(SAFER)-trial. Long-term survival and cost-effectiveness were projected based on observed 30-day outcomes and a validated survival model for postcoronary artery bypass graft patients. Compared with conventional treatment, distal protection increased initial procedural costs by～$1,600 ($6,326 vs. $4,779, p< 0.001). However, by reducing ischemic complications, distal protection reduced mean length of stay by 0.4 days and other hospital costs by nearly $1,000 ($6,846 vs. $7,811, p=0.018). As a result, overall initial hospital costs were only $582 per patient higher with distal protection. Based on the observed 30-day cost and outcome differences in the trial, the incremental cost-effectiveness ratio for distal protection was $3,718 per year of life saved and remained< $40,000 per year of life saved in 97.3%of bootstrap simulations (95%confidence interval, $0 to $43,079). For patients undergoing PCI of diseased SVGs, distal protection using the GuardWire system is an attractive use of limited health care resources.

比伐卢定加临时糖蛋白Ⅱb/Ⅲa抑制剂与肝素加常规糖蛋白Ⅱb/Ⅲa抑制剂对经皮冠状动脉介入手术作用的经济评估:来自REPLACE-2试验的结果

The purpose of this study was to compare the cost of percutaneous coronary intervention(PCI) using bivalirudin with provisional platelet glycoprotein(GP) Ⅱb/Ⅲa inhibition with that of heparin +routine GP Ⅱb/Ⅲa inhibition. Although GP Ⅱb/Ⅲa inhibition has been shown to reduce ischemic complications in a broad range of patients undergoingPCI, many patients currently do not receive such therapy because of concerns about bleeding complications or cost. Recently, bivalirudin with provisional GP Ⅱb/Ⅲa inhibition has been validated as an alternative to heparin+routine GP Ⅱb/Ⅲa inhibition for patients undergoing PCI. However, the cost-effectiveness of this novel strategy is unknown. In the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, 4,651 U.S. patients undergoing non-emergent PCI were randomized to receive bivalirudin with provisional GP Ⅱb/Ⅲa(n=2,319) versus heparin +routine GP Ⅱb/Ⅲa (n=2,332). Resource utilization data were collected prospectively through 30-day follow-up on all U.S.patients. Medical care costs were estimated using standard methods including bottom-upaccounting(for procedural costs), the Medicare fee schedule(for physician services), hospital billing data(for 2,821 of 4,862 admissions), and regression-based approaches for the remaining hospitalizations. Among the bivalirudin group, 7.7%required provisionalGP ⅡIb/Ⅲa. Thirty-day ischemic outcomes including death or myocardial infarction were similar for the bivalirudin and GP Ⅱb/Ⅲa groups, but bivalirudin resulted in lower rates of major bleeding (2.8%vs. 4.5%,p=0.002) and minor bleeding (15.1%vs. 28.1%, p < 0.001). Compared with routine GP Ⅱb/Ⅲa, in-hospital and 30-day costs were reduced by $405(95%confidence interval$37 to $773) and $374(95%CI $61 to $688) per patient with bivalirudin (p< 0.001 for both). Regression modeling demonstrated that, in addition to the costs of the anticoagulants themselves, hospital savings were due primarily to reductions in major bleeding(cost savings=$107/patient), minor bleeding($52/patient), and thrombocytopenia($47/patient). Compared with heparin+routine GP Ⅱb/Ⅲa inhibition, bivalirudin+provisional GP Ⅱb/Ⅲa inhibition resulted in similar acute ischemic events and cost savings of $375 to $400/patient depending on the analytic perspective.