Biomedical subjects

Daniel B Mark

Publications and source records attributed to Daniel B Mark.

At least 19 recordsLinked to original sources

PubMed2007

Is early too early? Effect of shorter stays after bypass surgery.

BACKGROUND: Postoperative stays after coronary artery bypass graft surgery (CABG) decreased substantially in the 1990s. Although shorter stays offer clinical benefits, premature discharge could increase adverse events and offset initial savings. This study examined the effect of early discharge after CABG on readmission/death and cost within 60 days of discharge home. Variability in hospitals' tendencies for early discharge and adverse outcomes was also explored. METHODS: Analyses were based on clinical and claims data for 55,889 New York CABG patients discharged home 1995 to 1998. Early discharge was defined as a postoperative stay below the 15th percentile for patients with similar risk. The likelihood of early discharge and its effect on readmission/death were examined using hierarchical logistic regression, accounting for patient risk and within-hospital correlation. The correlation between early discharge and adverse outcomes at the hospital level was assessed. The effect of early discharge on subsequent inpatient, outpatient, skilled nursing, and home health costs was examined in the Medicare subset. RESULTS: Overall, 17% of patients were discharged early, with increasing prevalence over time. The tendency to discharge early varied widely among hospitals (2% to 42% of patients). We found no association between hospitals' tendencies for early discharge and adverse outcomes. Lower postdischarge costs among patients discharged early (mean = 3,491 dollars versus 5,246 dollars for typical stays) resulted in average cumulative savings of 6,309 dollars. CONCLUSIONS: Patients selected for earlier discharge after CABG did not have increased adverse event rates or higher costs. Variation among hospitals in early discharge suggests that more efficient patient management could be achieved at some hospitals.

Aged↗

PubMed2006

Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation.

CONTEXT: Recent studies of drug-eluting intracoronary stents suggest that current antiplatelet regimens may not be sufficient to prevent late stent thrombosis. OBJECTIVE: To assess the association between clopidogrel use and long-term clinical outcomes of patients receiving drug-eluting stents (DES) and bare-metal stents (BMS) for treatment of coronary artery disease. DESIGN, SETTING, AND PATIENTS: An observational study examining consecutive patients receiving intracoronary stents at Duke Heart Center, a tertiary care medical center in Durham, NC, between January 1, 2000, and July 31, 2005, with follow-up contact at 6, 12, and 24 months through September 7, 2006. Study population included 4666 patients undergoing initial percutaneous coronary intervention with BMS (n = 3165) or DES (n = 1501). Landmark analyses were performed among patients who were event-free (no death, myocardial infarction [MI], or revascularization) at 6- and 12-month follow-up. At these points, patients were divided into 4 groups based on stent type and self-reported clopidogrel use: DES with clopidogrel, DES without clopidogrel, BMS with clopidogrel, and BMS without clopidogrel. MAIN OUTCOME MEASURES: Death, nonfatal MI, and the composite of death or MI at 24-month follow-up. RESULTS: Among patients with DES who were event-free at 6 months (637 with and 579 without clopidogrel), clopidogrel use was a significant predictor of lower adjusted rates of death (2.0% with vs 5.3% without; difference, -3.3%; 95% CI, -6.3% to -0.3%; P = .03) and death or MI (3.1% vs 7.2%; difference, -4.1%; 95% CI, -7.6% to -0.6%; P = .02) at 24 months. However, among patients with BMS (417 with and 1976 without clopidogrel), there were no differences in death (3.7% vs 4.5%; difference, -0.7%; 95% CI, -2.9% to 1.4%; P = .50) and death or MI (5.5% vs 6.0%; difference, -0.5%; 95% CI, -3.2% to 2.2%; P = .70). Among patients with DES who were event-free at 12 months (252 with and 276 without clopidogrel), clopidogrel use continued to predict lower rates of death (0% vs 3.5%; difference, -3.5%; 95% CI, -5.9% to -1.1%; P = .004) and death or MI (0% vs 4.5%; difference, -4.5%; 95% CI, -7.1% to -1.9%; P<.001) at 24 months. However, among patients with BMS (346 with and 1644 without clopidogrel), there continued to be no differences in death (3.3% vs 2.7%; difference, 0.6%; 95% CI, -1.5% to 2.8%; P = .57) and death or MI (4.7% vs 3.6%; difference, 1.0%; 95% CI, -1.6% to 3.6%; P = .44). CONCLUSIONS: The extended use of clopidogrel in patients with DES may be associated with a reduced risk for death and death or MI. However, the appropriate duration for clopidogrel administration can only be determined within the context of a large-scale randomized clinical trial.

Aged↗

PubMed2006

Coronary intervention for persistent occlusion after myocardial infarction.

BACKGROUND: It is unclear whether stable, high-risk patients with persistent total occlusion of the infarct-related coronary artery identified after the currently accepted period for myocardial salvage has passed should undergo percutaneous coronary intervention (PCI) in addition to receiving optimal medical therapy to reduce the risk of subsequent events. METHODS: We conducted a randomized study involving 2166 stable patients who had total occlusion of the infarct-related artery 3 to 28 days after myocardial infarction and who met a high-risk criterion (an ejection fraction of <50% or proximal occlusion). Of these patients, 1082 were assigned to routine PCI and stenting with optimal medical therapy, and 1084 were assigned to optimal medical therapy alone. The primary end point was a composite of death, myocardial reinfarction, or New York Heart Association (NYHA) class IV heart failure. RESULTS: The 4-year cumulative primary event rate was 17.2% in the PCI group and 15.6% in the medical therapy group (hazard ratio for death, reinfarction, or heart failure in the PCI group as compared with the medical therapy group, 1.16; 95% confidence interval [CI], 0.92 to 1.45; P=0.20). Rates of myocardial reinfarction (fatal and nonfatal) were 7.0% and 5.3% in the two groups, respectively (hazard ratio, 1.36; 95% CI, 0.92 to 2.00; P=0.13). Rates of nonfatal reinfarction were 6.9% and 5.0%, respectively (hazard ratio, 1.44; 95% CI, 0.96 to 2.16; P=0.08); only six reinfarctions (0.6%) were related to assigned PCI procedures. Rates of NYHA class IV heart failure (4.4% vs. 4.5%) and death (9.1% vs. 9.4%) were similar. There was no interaction between treatment effect and any subgroup variable (age, sex, race or ethnic group, infarct-related artery, ejection fraction, diabetes, Killip class, and the time from myocardial infarction to randomization). CONCLUSIONS: PCI did not reduce the occurrence of death, reinfarction, or heart failure, and there was a trend toward excess reinfarction during 4 years of follow-up in stable patients with occlusion of the infarct-related artery 3 to 28 days after myocardial infarction. (ClinicalTrials.gov number, NCT00004562 [ClinicalTrials.gov].).

Aged↗

PubMed2006

The high cost of implantable defibrillators.

Increased use of ICDs in patients with cardiac disease has the potential to strain national health care budgets because of the large numbers of eligible patients and the high cost of the ICDs. Randomized trials show ICDs increase life-expectancy in some groups of patients and also increase total medical costs significantly. ICDs exemplify the role of new technology as the main force behind rising health care costs. ICDs have not been used in all eligible patients, in part because of cost, but also because of patient resistance and a shortage of specialists able to implant and manage complex ICDs. The cost-effectiveness of ICDs would be improved by development of simpler and cheaper devices, and by better tools to identify patients who benefit from an ICD.

Arrhythmias, Cardiac↗

PubMed2006

Natriuretic peptides in the diagnosis and management of heart failure.

The natriuretic peptides are a family of related hormones that play a crucial role in cardiovascular homeostasis. They have recently emerged as potentially important clinical markers in heart failure. Recent data have suggested an important role for these markers in establishing the diagnosis of heart failure in patients with unexplained dyspnea in both acute care and ambulatory settings. Other clinical uses of the natriuretic peptides, such as screening for asymptomatic ventricular dysfunction, establishing prognosis or guiding titration of drug therapy, are under investigation but have not yet sufficiently been validated for widespread clinical use.

Atrial Natriuretic Factor↗

PubMed2006

Central nervous system injury associated with cardiac surgery.

Millions of individuals with coronary artery or valvular heart disease have been given a new chance at life by heart surgery, but the potential for neurological injury is an Achilles heel. Technological advancements and innovations in surgical and anaesthetic technique have allowed us to offer surgical treatment to patients at the extremes of age and infirmity-the group at greatest risk for neurological injury. Neurocognitive dysfunction is a complication of cardiac surgery that can restrict the improved quality of life that patients usually experience after heart surgery. With a broader understanding of the frequency and effects of neurological injury from cardiac surgery and its implications for patients in both the short term and the long term, we should be able to give personalised treatments and thus preserve both their quantity and quality of life. We describe these issues and the controversies that merit continued investigation.

Cognition Disorders↗

PubMed2006

Cost-effectiveness of defibrillator therapy or amiodarone in chronic stable heart failure: results from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).

BACKGROUND: In the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), implantable cardioverter-defibrillator (ICD) therapy significantly reduced all-cause mortality rates compared with medical therapy alone in patients with stable, moderately symptomatic heart failure, whereas amiodarone had no benefit on mortality rates. We examined long-term economic implications of these results. METHODS AND RESULTS: Medical costs were estimated by using hospital billing data and the Medicare Fee Schedule. Our base case cost-effectiveness analysis used empirical clinical and cost data to estimate the lifetime incremental cost of saving an extra life-year with ICD therapy relative to medical therapy alone. At 5 years, the amiodarone arm had a survival rate equivalent to that of the placebo arm and higher costs than the placebo arm. For ICD relative to medical therapy alone, the base case lifetime cost-effectiveness and cost-utility ratios (discounted at 3%) were dollar 38,389 per life-year saved (LYS) and dollar 41,530 per quality-adjusted LYS, respectively. A cost-effectiveness ratio < dollar 100,000 was obtained in 99% of 1000 bootstrap repetitions. The cost-effectiveness ratio was sensitive to the amount of extrapolation beyond the empirical 5-year trial data: dollar 127,503 per LYS at 5 years, dollar 88,657 per LYS at 8 years, and dollar 58,510 per LYS at 12 years. Because of a significant interaction between ICD treatment and New York Heart Association class, the cost-effectiveness ratio was dollar 29,872 per LYS for class II, whereas there was incremental cost but no incremental benefit in class III. CONCLUSIONS: Prophylactic use of single-lead, shock-only ICD therapy is economically attractive in patients with stable, moderately symptomatic heart failure with an ejection fraction < or = 35%, particularly those in NYHA class II, as long as the benefits of ICD therapy observed in the SCD-HeFT persist for at least 8 years.

Adult↗

PubMed2006

The value of estimated functional capacity in estimating outcome: results from the NHBLI-Sponsored Women's Ischemia Syndrome Evaluation (WISE) Study.

OBJECTIVES: Our objective was to determine the prognostic value of estimated metabolic equivalents (METs) based on self-reported functional capacity by the Duke Activity Status Index (DASI) in symptomatic women. BACKGROUND: Functional capacity is an important component affecting the predictive value of exercise testing, yet current guidelines offer limited assistance regarding identification of functional impairment and choice of pharmacologic stress testing. METHODS: A total of 914 women underwent clinically indicated coronary angiography and completed the 12-item DASI questionnaire; a subgroup of 251 women also underwent exercise testing. Cox proportional hazards modeling was used to estimate five-year death or myocardial infarction by DASI scores. In a secondary analysis, additional events included unstable angina, heart failure, or stroke at five years. RESULTS: Average DASI-estimated functional capacity was 5.7 +/- 4.2 METs and, for exercising women, 6.0 +/- 2.6 METs. In the 914 women, event-free survival ranged from 83% to 95% in subgroups with < or =4.7 to >9.9 METs (p = 0.009); 67% of the events occurred in women scoring < or =4.7 METs (p = 0.003). Event rates were similar by exercise and DASI MET values. In women with DASI-estimated METs < or =4.7 (n = 75), ischemia occurred less (39% vs. 64%, p < 0.0001), and exercise testing results were more often indeterminate (<85% predicted maximum heart rate = 37% vs. 6%, p = 0.001) as compared to women achieving >4.7 METs. CONCLUSIONS: Among women with suspected myocardial ischemia, functional impairment estimated by the DASI correlates with indeterminate exercise test results and is associated with an adverse prognosis. Use of the DASI before exercise testing can risk stratify symptomatic women and may improve the identification of higher-risk, functionally impaired subjects that would benefit from pharmacologic stress imaging and targeted risk management.

Adult↗

PubMed2006

Costs for heart failure with normal vs reduced ejection fraction.

BACKGROUND: Among the elderly population, heart failure (HF) with normal ejection fraction (EF) is more common than classic HF with low EF. However, there are few data regarding the costs of HF with normal EF. In a prospective, population-based cohort of elderly participants, we compared the costs and resource use of patients with HF and normal and reduced EF. METHODS: A total of 4549 participants (84.5% white; 40.6% male) in the National Heart, Lung, and Blood Institute Cardiovascular Health Study were linked to Medicare claims from 1992 through 1998. By protocol echo examinations or clinical EF assessments, 881 participants with HF were characterized as having abnormal or normal EF. We applied semiparametric estimators to calculate mean costs per subject for a 5-year period. RESULTS: There were 495 HF participants with normal EF (186 prevalent at study entry and 309 incident during the study period) and 386 participants with abnormal EF (166 prevalent and 220 incident). Participants with abnormal EF had more cardiology encounters and cardiac procedures. However, compared with abnormal EF participants, the 5-year costs for normal EF participants were similar in both the prevalent ($33,023 with abnormal EF and $32,580 with normal EF; P=.93) and incident ($49,128 with abnormal EF and $45,604 with normal EF; P=.55) groups. In models accounting for comorbid conditions, the costs with normal and abnormal EF remained similar. CONCLUSIONS: Over a 5-year period, patients with HF and normal EF consume as many health care resources as those with reduced EF. These data highlight the substantial financial burden of HF with normal EF among the elderly population.

Aged↗

PubMed2006

Trends in postoperative length of stay after bypass surgery.

BACKGROUND: Although single-site studies have reported reductions in coronary artery bypass graft (CABG) surgery length of stay (LOS) over the last 15 years, less information is available regarding overall temporal trends and interhospital variability. This study examined trends in postoperative LOS, associated rates of transfer at discharge and variation among hospitals in LOS at CABG hospitals in New York State. METHODS: Trends in postoperative LOS and transfers at discharge for 105,842 CABG patients treated in 30 hospitals in New York between 1992 and 1998 were first described graphically. Mixed models were then used to assess temporal trends and interhospital variability in LOS, accounting for differences in patient risk and within-hospital correlation in outcomes. Clinical and LOS data were obtained from the Cardiac Surgery Reporting System. Additional information was extracted from the New York Statewide Planning and Research Cooperative System. RESULTS: Postoperative LOS decreased 30% between 1992 and 1998 after adjusting for patient risk. A concurrent increase in the probability of nonacute patient transfers occurred over time, with the most pronounced increase in patients with stays exceeding 5 days. Underlying the downward trend in LOS was substantial interhospital variability that peaked in 1994 and remained significant in 1998. Stays were longer at hospitals located in New York City. CONCLUSIONS: The downward shift in LOS observed in the 1990s was achieved in part by an increase in nonacute care transfers, reflecting a shift in care setting. After decreasing trends in postoperative stays tapered off, significant variability among hospitals remained.

Aged↗

PubMed2006

Role of amiodarone or implantable cardioverter/defibrillator in patients with atrial fibrillation and heart failure.

BACKGROUND: Heart failure complicated by atrial fibrillation (AF) is associated with excessive mortality and morbidity. The aim of the study was to determine the role of amiodarone or implantable cardioverter/defibrillator (ICD) in patients with AF and heart failure. METHODS: Patients were determined to be in sinus rhythm (SR) or AF on the baseline electrocardiogram. Mortality, ICD discharge, or change in rhythm was assessed. RESULTS: Of the 2521 patients at baseline, 2328 were in SR and 173 were in AF. Overall, after adjusting for differences in baseline variables, there was no difference in mortality between patients with SR and patients with AF (P = .98), nor within assigned groups: placebo (P) (P = .82), amiodarone (A) (P = .68), and ICD (P = .40). For patients with SR, ICD decreased mortality (P vs ICD, P = .004; A vs ICD, P = .004; P vs A, P = .75). For patients with AF, there were no differences in mortality among groups (P vs ICD, P = .99; A vs ICD, P = .88; P vs A, P = .88). Of patients with SR at baseline, 11% (264) developed AF by any electrocardiogram during follow-up (P 12%, A 8%, ICD 15%; A vs P, P = .019; A vs ICD, P = .001; P vs ICD, P = .044). Of patients with AF, 70% (121) developed SR during follow-up (P 66%, A 67%, ICD 75%, all P = not significant against each other). Any ICD shock was seen in 52% (34) of patients with AF vs 30% (222) of patients with SR (P = .001). Inappropriate shocks were seen in 37% (24) of patients with AF vs 14% (107) of patients with SR (P = .001). Appropriate shocks were more often seen in AF vs SR (P = .03). CONCLUSION: After adjustments for baseline differences, patients with AF and patients with SR have similar overall mortality rates. Compared to P or A, ICD improves survival in patients with SR, but may not in patients with AF. Amiodarone is effective in reducing new AF, but not in converting AF to SR. Implantable cardioverter/defibrillator, inappropriate, and appropriate shocks were more often seen in AF than in SR.

Aged↗

PubMed2006

What is the economic value of digoxin therapy in congestive heart failure patients? Results from the DIG trial.

BACKGROUND: The Digitalis Investigation Group (DIG) clinical train randomized 6800 congestive heart failure patients (ejection fraction > or =45%) to a daily regimen of either digoxin or placebo. At 37 months average follow-up, patients in both groups had similar mortality. We determined the incremental costs associated with the use of digoxin in this high-risk population. METHODS AND RESULTS: Hospitalizations and medical costs were compared by using a societal perspective. Hospitalizations were assigned Medicare DRG codes by using descriptive information from the clinical trial. Digoxin use was assigned a cost by using the 1998 average wholesale price as reported by Red Book. On average, there were fewer hospitalizations in digoxin-treated patients. These patients had lower heart failure yet higher non-heart failure hospitalization costs than placebo patients. Digoxin therapy was cost saving versus placebo in only 27% of 1000 bootstrap samples using Medicare costs (mean costs 12,648 dollars vs. 12,362 dollars) and in 44% of samples using commercial carrier costs (mean costs 17,400 dollars vs. 17,306 dollars). How ever, digoxin was cost saving in >50% of samples for several higher-risk patient subgroups. CONCLUSIONS: The use of digoxin therapy versus placebo was associated with reduced hospitalizations. Moreover, the resulting cost-savings could cover the costs of this inexpensive therapy in selected subgroups of higher-risk patients. In the remainder, there is a modest cost associated with this therapy.

Aged↗

PubMed2005

Cardiac resynchronization therapy: Part 1--issues before device implantation.

Cardiac resynchronization therapy (CRT) has been used extensively over the last years in the therapeutic management of patients with end-stage heart failure. Data from 4,017 patients have been published in eight large, randomized trials on CRT. Improvement in clinical end points (symptoms, exercise capacity, quality of life) and echocardiographic end points (systolic function, left ventricular size, mitral regurgitation) have been reported after CRT, with a reduction in hospitalizations for decompensated heart failure and an improvement in survival. However, individual results vary, and 20% to 30% of patients do not respond to CRT. At present, the selection criteria include severe heart failure (New York Heart Association functional class III or IV), left ventricular ejection fraction <35%, and wide QRS complex (>120 ms). Assessment of inter- and particularly intraventricular dyssynchrony as provided by echocardiography (predominantly tissue Doppler imaging techniques) may allow improved identification of potential responders to CRT. In this review a summary of the clinical and echocardiographic results of the large, randomized trials is provided, followed by an extensive overview on the currently available echocardiographic techniques for assessment of LV dyssynchrony. In addition, the value of LV scar tissue and venous anatomy for the selection of potential candidates for CRT are discussed.

Cardiac Output, Low↗

PubMed2005

Cardiac resynchronization therapy: Part 2--issues during and after device implantation and unresolved questions.

Encouraged by the clinical success of cardiac resynchronization therapy (CRT), the implantation rate has increased exponentially, although several limitations and unresolved issues of CRT have been identified. This review concerns issues that are encountered during implantation of CRT devices, including the role of electroanatomical mapping, whether CRT implantation should be accompanied by simultaneous atrioventricular nodal ablation in patients with atrial fibrillation, procedural complications, and when to consider surgical left ventricular lead positioning. Furthermore, (echocardiographic) CRT optimization and assessment of CRT benefits after implantation are highlighted. Also, controversial issues such as the potential value of CRT in patients with mild heart failure or narrow QRS complex are addressed. Finally, open questions concerning when to combine CRT with implantable cardioverter-defibrillator therapy and the cost-effectiveness of CRT are discussed.

Atrial Fibrillation↗

PubMed2005

A new anatomic score for prognosis after cardiac catheterization in patients with previous bypass surgery.

OBJECTIVES: The purpose of this study was to determine the value of a new anatomic score for prognosis after diagnostic catheterization in patients with previous coronary artery bypass grafting (CABG). BACKGROUND: Previous CABG patients comprise a growing proportion of patients with coronary artery disease (CAD). Whereas prognostic scores are available to adjust for native CAD, there are no comparable scores for patients with previous CABG. METHODS: We studied 3,178 previous CABG patients (2,729 in a training set) who underwent cardiac catheterization. With a Cox model to develop relative weights in the training set, we created a graft index that adjusted native anatomy for territories with grafts free of significant (> or =75%) stenoses. Scaling the regression coefficients by the maximum coefficient created an index ranging from 0 to 100, where 100 was three-vessel CAD with no patent grafts. RESULTS: The graft index was significantly associated with all-cause death (chi-square = 121.9, p < 0.001). In combined models, the index was more strongly associated with all-cause death than either number of diseased vessels (chi-square = 68.0 and 1.7, respectively) or the Duke CAD index (chi-square = 54.3 and 9.5, respectively). In models for death using an independent validation set, the index was also associated more strongly than either native disease descriptors. In a model including other clinical variables, the graft index remained significantly associated with all-cause death (chi-square = 40.1, p < 0.001). CONCLUSIONS: For previous CABG patients, the Duke graft index was significantly more associated with prognosis than native anatomy alone and quantifies the effect of patent grafts on survival. This tool has the potential to help determine prognosis and inform the referral of post-CABG patients to repeat revascularization procedures.

Aged↗

PubMed2005

Hostility, age, and mortality in a sample of cardiac patients.

This study examined hostility as a predictor of survival in a sample of 1,328 patients who had documented coronary artery disease. After controlling for disease severity, there was a significant interaction between age and hostility. Hostility was significantly associated with poorer survival but only in younger (<61.2 years) patients.

Age Factors↗

PubMed2005

Ratings of positive and depressive emotion as predictors of mortality in coronary patients.

BACKGROUND: An extensive body of research has demonstrated an association between negative affective states and health outcomes. Positive emotions may also influence physical health, however, their examination has received far less attention. METHODS: Positive and depressive emotion ratings were examined as independent and joint predictors of survival in a sample of 866 cardiac catheterization patients. The mean follow-up was 11.4 years, during which 415 deaths occurred. The mean age of the sample was 60.3 years and 74.3% of the sample were males. RESULTS: Both positive and depressive ratings were associated with survival (hazard ratio=0.80, 95% CI=0.66-0.97, p<0.025 and hazard ratio=1.32, 95% CI=1.13-1.54, p<0.001, respectively), adjusted for risk factors. Positive emotion ratings were no longer significantly related to mortality when the two emotion measures were simultaneously included in a survival model. CONCLUSION: The current findings are consistent with a theory that suggests that the relation between positive emotion and mortality may be partly mediated by depressive emotion.

Coronary Disease↗

PubMed2005

Clinical and economic implications of the Multicenter Automatic Defibrillator Implantation Trial-II.

BACKGROUND: The Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II demonstrated that implantable cardioverter defibrillators (ICDs) save lives when used in patients with a history of myocardial infarction (MI) and an ejection fraction of 0.3 or less. OBJECTIVE: To investigate the cost-effectiveness of implanting ICDs in patients who met MADIT-II eligibility criteria and were enrolled in the Duke Cardiovascular Database between 1 January 1986 and 31 December 2001. DESIGN: Cost-effectiveness analysis. DATA SOURCES: Published literature, databases owned by Duke University Medical Center, and Medicare data. TARGET POPULATION: Adults with a history of MI and an ejection fraction of 0.3 or less. TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTIONS: ICD therapy versus conventional medical therapy. OUTCOMES MEASURES: Cost per life-year gained and incremental cost-effectiveness. RESULTS: Compared with conventional medical therapy, ICDs are projected to result in an increase of 1.80 discounted years in life expectancy and an incremental cost-effectiveness ratio of 50,500 dollars per life-year gained. Cost-effectiveness varied dramatically with changes in time horizon: The cost-effectiveness ratio increased to 67,800 dollars per life-year gained, 79,900 dollars per life-year gained, 100,000 dollars per life-year gained, 167,900 dollars per life-year gained, and 367,200 dollars per life-year gained for 15-year, 12-year, 9-year, 6-year, and 3-year time horizons, respectively. Changing the frequency of follow-up visits, complication rates, and battery replacements had less of an effect on the cost-effectiveness ratios than reducing the cost of ICD placement and leads. LIMITATIONS: The study was limited by the completeness of the data, referral bias, difference in medical therapy between the Duke cohort and the MADIT-II cohort, and not addressing potential upgrades to biventricular devices. CONCLUSIONS: The economic expense of defibrillator implantation in all patients who meet MADIT-II eligibility criteria is substantial. However, in the range of survival benefit observed in MADIT-II, ICD therapy for these patients is economically attractive by conventional standards.

Adult↗