Objectives The aim of this study was to determine if the benefit of implantable cardioverter-defibrillators (ICDs) is modulated by medical comorbidity. Background Primary prevention ICDs improve survival in patients at risk for sudden cardiac death. Their benefit in patients with significant comorbid illness has not been demonstrated. Methods Original, patient-level datasets from MADIT I (Multicenter Automatic Defibrillator Implantation Trial I), MADIT II, DEFINITE (Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation), and SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) were combined. Patients in the combined population (N = 3,348) were assessed with respect to the following comorbidities: smoking, pulmonary disease, diabetes, peripheral vascular disease, atrial fibrillation, ischemic heart disease, and chronic kidney disease. The primary outcome was overall mortality, using the hazard ratio (HR) of time to death for patients receiving an ICD versus no ICD by extent of medical comorbidity, and adjusted for age, sex, race, left ventricular ejection fraction, use of antiarrhythmic drugs, beta-blockers, and angiotensin-converting enzyme inhibitors. Results Overall, 25% of patients (n = 830) had  Conclusions Patients with extensive comorbid medical illnesses may experience less benefit from primary prevention ICDs than those with less comorbidity; implantation should be carefully considered in sick patients. Further study of ICDs in medically complex patients is warranted.

Outcomes of Implantable Cardioverter-Defibrillator Use in Patients With Comorbidities: Results From a Combined Analysis of 4 Randomized Clinical Trials

New medical technologies are a leading driver of U.S. health care spending. This article identifies promising policy options to change which medical technologies are created, with two related policy goals: (1) Reduce total health care spending with the smallest possible loss of health benefits, and (2) ensure that new medical products that increase spending are accompanied by health benefits that are worth the spending increases. The analysis synthesized information from peer-reviewed and other literature, a panel of technical advisors convened for the project, and 50 one-on-one expert interviews. The authors also conducted case studies of eight medical products. The following features of the U.S. health care environment tend to increase spending without also conferring major health benefits: lack of basic scientific knowledge about some disease processes, costs and risks of U.S. Food and Drug Administration (FDA) approval, limited rewards for medical products that could lower spending, treatment creep, and the medical arms race. The authors identified ten policy options that would help advance the two policy goals. Five would do so by reducing the costs and/or risks of invention and obtaining FDA approval: (1) Enable more creativity in funding basic science, (2) offer prizes for inventions, (3) buy out patents, (4) establish a public-interest investment fund, and (5) expedite FDA reviews and approvals. The other five options would do so by increasing market rewards for products: (1) Reform Medicare payment policies, (2) reform Medicare coverage policies, (3) coordinate FDA approval and Centers for Medicare & Medicaid Services coverage processes, (4) increase demand for technologies that decrease spending, and (5) produce more and more-timely technology assessments.

/pdf/redirecting-innovation-in-u-s-health-care-options-to-c9ko488n2k.pdf

Redirecting Innovation in U.S. Health Care: Options to Decrease Spending and Increase Value

Utilization of cardiac resynchronization therapy in eligible patients hospitalized for heart failure and its association with patient outcomes.

Background Previous systematic reviews of implantable cardioverter defibrillators (ICDs) used for primary prevention of sudden cardiac death (SCD) concluded that ICDs are less effective in women and the elderly. Purpose To examine ICD effectiveness for primary prevention of SCD across subgroups by sex, age, New York Heart Association class, left ventricular ejection fraction, heart failure, left bundle branch block, QRS interval, time since myocardial infarction, blood urea nitrogen level, and diabetes. Data sources MEDLINE and the Cochrane Central Register of Controlled Trials through 3 September 2013 with no language restriction. Study selection Researchers screened articles for studies comparing ICD versus no ICD for primary prevention. Data extraction Data were extracted about study design, patients, interventions, mortality and SCD outcomes, subgroup characteristics, and subgroup effects. Quality of subgroup analyses was determined by consensus. Relative odds ratios comparing subgroup effects were calculated, and random-effects model meta-analyses were conducted on these ratios. Data synthesis Meta-analysis of 14 studies showed a decrease in deaths and SCDs due to ICD treatment. Ten studies provided subgroup analyses. Nine studies compared ICD versus no ICD, whereas one compared cardiac resynchronization therapy plus a defibrillator versus no ICD. Within-study interaction tests and across-study meta-analyses yielded weak evidence that did not show differences for all-cause mortality in subgroups by sex, age, and QRS interval. The evidence was indeterminate for other evaluated subgroups because of a paucity of data. Limitation Many subgroup analyses were underpowered, which may have resulted in false-negative findings. Conclusion Weak evidence fails to show differences for all-cause mortality in subgroups of sex, age, and QRS interval. Evidence is indeterminate for all-cause mortality in the other subgroups and for SCD. Primary funding source Agency for Healthcare Research and Quality.

Effectiveness of implantable cardioverter defibrillators for primary prevention of sudden cardiac death in subgroups a systematic review

Background— Large-scale data on outcomes with cardiac resynchronization therapy with defibrillator in patients with diabetes mellitus are limited. We compared outcomes after cardiac resynchronization therapy with defibrillator implantation among patients with heart failure who have diabetes mellitus versus those without diabetes mellitus.

Methods and Results— Survival curves and covariate adjusted hazard ratio (HR) or odds ratio were used to assess the risks for death, readmission, and device-related complications by diabetes mellitus status among 18 428 patients at least 65 years old receiving cardiac resynchronization therapy with defibrillator from the National Cardiovascular Data Registry, implantable cardioverter-defibrillator registry between 2006 and 2009, with up to 3 years of follow-up. Accounting for differences between groups, compared with those without diabetes mellitus (n=11 345), patients with diabetes mellitus (n=7083) had a higher risk of death both at 1 year (HR, 1.16 [95% confidence interval (CI), 1.05–1.29]; P =0.0037) and 3 years (HR, 1.21 [1.14–1.29]; P <0.001) after device implantation and higher risks of all-cause readmission (sub-HR, 1.16 [1.11–1.21] at 1 year; P <0.0001; sub-HR, 1.15 [1.11–1.19] at 3 years; P <0.0001) and heart failure–related readmission (sub-HR, 1.18 [1.09–1.28] at 1 year; P <0.0001; and sub-HR, 1.22 [1.15–1.30] at 3 years; P <0.0001). Device-related complications within 90 days did not differ between those with and without diabetes mellitus (odds ratio: 0.90 [0.77–1.06]; P =0.37). Interactions of age, sex, ischemic cardiomyopathy, renal failure, or QRS duration were not significant.

Conclusions— In older patients with heart failure receiving cardiac resynchronization therapy with defibrillator, diabetes mellitus was independently associated with greater risks of death and rehospitalization, but similar risks of procedural complications.

Diabetes Mellitus and Outcomes of Cardiac Resynchronization With Implantable Cardioverter-Defibrillator Therapy in Older Patients With Heart Failure.

Background—Implantable cardioverter-defibrillators (ICDs) are increasingly used for primary prevention after randomized, controlled trials demonstrating that they reduce the risk of death in patients with left ventricular systolic dysfunction. The extent to which the clinical characteristics and long-term outcomes of unselected, community-based patients with left ventricular systolic dysfunction undergoing primary prevention ICD implantation in a real-world setting compare with those enrolled in the randomized, controlled trials is not well characterized. This study is being conducted to address these questions. Methods and Results—The study cohort includes consecutive patients undergoing primary prevention ICD placement between January 1, 2006 and December 31, 2009 in 7 health plans. Baseline clinical characteristics were acquired from the National Cardiovascular Data Registry ICD Registry. Longitudinal data collection is underway, and will include hospitalization, mortality, and resource use from standa...

Longitudinal Study of Implantable Cardioverter-Defibrillators Methods and Clinical Characteristics of Patients Receiving Implantable Cardioverter-Defibrillators for Primary Prevention in Contemporary Practice

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Longitudinal Study of Implantable Cardioverter-Defibrillators Methods and Clinical Characteristics of Patients Receiving Implantable Cardioverter-Defibrillators for Primary Prevention in Contemporary Practice