Cost-effectiveness of implantable cardiac devices in patients with systolic heart failure.

OBJECTIVE: To evaluate the cost-effectiveness of implantable cardioverter defibrillators (ICDs), cardiac resynchronisation therapy pacemakers (CRT-Ps) and combination therapy (CRT-D) in patients with heart failure with reduced ejection fraction based on a range of clinical characteristics. METHODS: Individual patient data from 13 randomised trials were used to inform a decision analytical model. A series of regression equations were used to predict baseline all-cause mortality, hospitalisation rates and health-related quality of life and device-related treatment effects. Clinical variables used in these equations were age, QRS duration, New York Heart Association (NYHA) class, ischaemic aetiology and left bundle branch block (LBBB). A UK National Health Service perspective and a lifetime time horizon were used. Benefits were expressed as quality-adjusted life-years (QALYs). Results were reported for 24 subgroups based on LBBB status, QRS duration and NYHA class. RESULTS: At a threshold of £30 000 per QALY gained, CRT-D was cost-effective in 10 of the 24 subgroups including all LBBB morphology patients with NYHA I/II/III. ICD is cost-effective for all non-NYHA IV patients with QRS duration <120 ms and for NYHA I/II non-LBBB morphology patients with QRS duration between 120 ms and 149 ms. CRT-P was also cost-effective in all NYHA III/IV patients with QRS duration >120 ms. Device therapy is cost-effective in most patient groups with LBBB at a threshold of £20 000 per QALY gained. Results were robust to altering key model parameters. CONCLUSIONS: At a threshold of £30 000 per QALY gained, CRT-D is cost-effective in a far wider group than previously recommended in the UK. In some subgroups ICD and CRT-P remain the cost-effective choice.

Medtronic Sprint Fidelis lead recall: determining the initial 5-year management cost to Medicare.

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.