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Women might benefit more than men from cardiac resynchronization therapy (CRT) and do so at shorter QRS durations. This meta-analysis was performed to determine whether sex-based differences in CRT effects are better accounted for by height, body surface area (BSA), or left ventricular end-diastolic dimension (LVEDD). We analyzed patient-level data from CRT trials (MIRACLE, MIRACLE ICD, MIRACLE ICD II, REVERSE, RAFT, COMPANION, and MADIT-CRT) using bayesian hierarchical Weibull regression models. Relationships between QRS duration and CRT effects were examined overall and in sex-stratified cohorts; additional analyses indexed QRS duration by height, BSA, or LVEDD. End points were heart failure hospitalization (HFH) or death and all-cause mortality. Compared with men (n = 5628), women (n = 1439) were shorter (1.62 [interquartile range, 1.57–1.65] m vs 1.75 [1.70–1.80] m; P <.001), with smaller BSAs (1.76 [1.62–1.90] m2 vs 2.02 [1.89–2.16] m2; P <.001). In adjusted sex-stratified analyses, the reduction in HFH or death was greater for women (hazard ratio, 0.54; credible interval, 0.42–0.70) than for men (hazard ratio, 0.77; credible interval, 0.66–0.89; P interaction =.009); results were similar for all-cause mortality even after adjustment for height, BSA, and LVEDD. Sex-specific differences were observed only in nonischemic cardiomyopathy. The effect of CRT on HFH or death was observed at a shorter QRS duration for women (126 ms) than for men (145 ms). Indexing QRS duration by height, BSA, or LVEDD attenuated sex-specific QRS duration thresholds for the effects of CRT on HFH or death but not on mortality. Although body size partially explains sex-specific QRS duration thresholds for CRT benefit, it is not associated with the magnitude of CRT benefit. Indexing QRS duration for body size might improve selection of patients for CRT, particularly with a "borderline" QRS duration. [Display omitted] [ABSTRACT FROM AUTHOR]

Cardiac resynchronization therapy (CRT) reduces heart failure hospitalizations (HFH) and mortality for guideline-indicated patients with heart failure (HF). Most patients with HF are aged ≥70 years but such patients are often under-represented in randomized trials. Patient-level data were combined from 8 randomized trials published 2002-2013 comparing CRT to no CRT (n = 6,369). The effect of CRT was estimated using an adjusted Bayesian survival model. Using age as a categorical (<70 vs ≥70 years) or continuous variable, the interaction between age and CRT on the composite end point of HFH or all-cause mortality or all-cause mortality alone was assessed. The median age was 67 years with 2436 (38%) being 70+; 1,554 (24%) were women; 2,586 (41%) had nonischemic cardiomyopathy and median QRS duration was 160 ms. Overall, CRT was associated with a delay in time to the composite end point (adjusted hazard ratio [aHR] 0.75, 95% credible interval [CI] 0.66-0.85, P =.002) and all-cause mortality alone (aHR of 0.80, 95% CI 0.69-0.96, P =.017). When age was treated as a categorical variable, there was no interaction between age and the effect of CRT for either end point (P >.1). When age was treated as a continuous variable, older patients appeared to obtain greater benefit with CRT for the composite end point (P for interaction =.027) with a similar but nonsignificant trend for mortality (P for interaction =.35). Reductions in HFH and mortality with CRT are as great or greater in appropriately indicated older patients. Age should not be a limiting factor for the provision of CRT. [ABSTRACT FROM AUTHOR]

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ahj.2010.04.021 Byline: Gillian D. Sanders, Melissa H. Kong, Sana M. Al-Khatib, Eric D. Peterson Abstract: More than 80% of sudden cardiac deaths (SCDs) occur in patients [greater than or equal to]65 years old; the cost-effectiveness of implantable cardioverter defibrillator (ICD) therapy in older patients remains unclear. We sought to examine the cost-effectiveness of ICD therapy in at-risk patients [greater than or equal to]65 years old. Author Affiliation: Duke Clinical Research Institute, Duke University, Durham, NC Article History: Received 12 November 2009; Accepted 24 April 2010

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ahj.2006.10.023 Byline: Manesh R. Patel (a), Lynne M. Hurwitz (a), Lori Orlando (b), Douglas C. McCrory (b), Gillian D. Sanders (a)(b), David B. Matchar (b), Daniel Mark (b) Abstract: This report describes a review of the available scientific evidence through 2005 on direct noninvasive imaging tests (NITs) for coronary artery disease. In particular, the report addresses 6 key questions provided by the Agency for Healthcare Research and Quality and the Centers for Medicare and Medicaid Services. The questions examine the degree to which current evidence supports confident judgments about the use of NITs in the assessment of native coronary artery stenosis in clinical practice. The 2 NITs that are examined in detail in this report are 16 (and higher)-multidetector computed tomography angiography and 1.5-T magnetic resonance angiography to evaluate for stenosis in native coronary arteries. Reported sensitivity of NITs ranged from 68% to 100%; reported specificity ranged from 57% to 100% (patient-based analysis). Limitations include the exclusion of significant numbers of segments and patients, with often only the proximal coronary segments visualized. There is no direct evidence assessing the clinical use of NITs in terms of the incremental benefits or risks compared to alternative testing strategies. Although the ability of noninvasive direct coronary imaging technologies is promising -- particularly the 64-multidetector computed tomography angiography -- the evidence does not provide strong guidance on whether and how such technologies should be used in the population generally, or for Medicare beneficiaries specifically. Informed clinical and policy decision making will require further study of these technologies in well-characterized clinical contexts, in typical practice settings, and with attention to impact on management and health outcomes. Author Affiliation: (a) Division of Cardiology, Duke University Medical Center, Duke Clinical Research Institute, Duke University, Durham, NC (b) Duke Evidence Based Practice Center, Duke University, Durham, NC Article History: Received 27 October 2006; Accepted 27 October 2006 Article Note: (footnote) This review is a shortened version of the technology assessment commissioned from the authors by the Agency for Health Care Research and Quality (AHRQ) on behalf of the Medicare Coverage Committee. It was discussed at the MCAC public meeting on May 18, 2006, Baltimore, MD.

Background: Cardiac resynchronization therapy (CRT) has been demonstrated to improve heart failure (HF) symptoms, reverse LV remodeling, and reduce mortality and HF hospitalization (HFH) in patients with a reduced left ventricular (LV) ejection fraction (LVEF). Prior studies examining outcomes based on right ventricular (RV) lead position among CRT patients have provided mixed results. We performed a systematic review and meta-analysis of randomized controlled trials and prospective observational studies comparing RV apical (RVA) and non-apical (RVNA) lead position in CRT.Methods: Our meta-analysis was constructed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for systematic reviews and meta-analyses. We searched EMBASE and MEDLINE. Eligible studies reported on at least one of the following outcomes of interest: all-cause mortality, the composite endpoint of death and first HFH hospitalization, change in LVEF, New York Heart Association (NYHA) class improvement, and change in LV end systolic volume (LVESV). We performed meta-analysis summaries using a DerSimonian-Laird random-effects model and conservatively used the Knapp-Hartung approach to adjust the standard errors of the estimated model coefficients.Results: We included nine studies representing a total of 1832 patients. Of those, 1318 (72%) patients had RVA lead placement and 514 (28%) had RVNA lead placement. The mean age of patients was 65.5 ± 4.4 years, and they were predominantly men (69%-97%). There was no statistically significant difference in all-cause mortality by RVA vs. RVNA (OR = 0.77, 95% CI 0.32-1.89; I2 = 16.7%, p = 0.31), or in the combined endpoint of all-cause mortality and first HFH (OR 0.88, 95% CI 0.62-1.25; I2 = 0%, p = 0.84). Also, there was no difference between RVA and RVNA for NYHA class improvement (OR = 1.03, 95% CI 0.9-1.17; I2 = 0%, p = 0.99), change in LVEF (mean difference (MD) = 1.33, 95% CI -1.45 to 4.10; I2 = 47%; p = 0.093), and change in LVESV (MD = -1.11, 95% CI -3.34 to 1.12; I2 = 0%; p = 0.92).Conclusion: This meta-analysis shows that in CRT pacing, RV lead position does not appear to be associated with clinical outcomes or LV reverse remodeling. Further studies should focus on the relationship of RV lead vis-à-vis LV lead location, and its clinical importance. [ABSTRACT FROM AUTHOR]

Background: Although cardiac resynchronization therapy (CRT) is effective for some patients with heart failure and a reduced left ventricular ejection fraction (HFrEF), evidence gaps remain for key clinical and policy areas. The objective of the study was to review the data on the effects of CRT for patients with HFrEF receiving pharmacological therapy alone or pharmacological therapy and an implantable cardioverter-defibrillator (ICD) and then, informed by a diverse group of stakeholders, to identify evidence gaps, prioritize them, and develop a research plan.Methods: Relevant studies were identified using PubMed and EMBASE and ongoing trials using clinicaltrials.gov. Forced-ranking prioritization method was applied by stakeholders to reach a consensus on the most important questions. Twenty-six stakeholders contributed to the expanded list of evidence gaps, including key investigators from existing randomized controlled trials and others representing different perspectives, including patients, the public, device manufacturers, and policymakers.Results: Of the 18 top-tier evidence gaps, 8 were related to specific populations or subgroups of interest. Seven were related to the comparative effectiveness and safety of CRT interventions or comparators, and 3 were related to the association of CRT treatment with specific outcomes. The association of comorbidities with CRT effectiveness ranked highest, followed by questions about the effectiveness of CRT among patients with atrial fibrillation and the relationship between gender, QRS morphology and duration, and outcomes for patients either with CRT plus ICD or with ICD.Conclusions: Evidence gaps presented in this article highlight numerous, important clinical and policy questions for which there is inconclusive evidence on the role of CRT and provide a framework for future collaborative research. [ABSTRACT FROM AUTHOR]

Background: Chronic lower extremity venous disease (LECVD) is twice as prevalent as coronary heart disease, and invasive therapies to treat LECVD accounted for an estimated $290 million in Medicare expenditures in 2015. Despite increasing use of these invasive therapies, their comparative effectiveness is unknown.Methods: We conducted a systematic review and meta-analysis of treatments for patients (symptomatic and asymptomatic) with lower extremity varicosities and/or lower extremity chronic venous insufficiency/incompetence/reflux. We searched PubMed, Embase, and the Cochrane Database of Systematic Reviews for relevant English-language studies published from January 2000 to July 2016. We included comparative randomized controlled trials (RCTs) with >20 patients and observational studies with >500 patients. Short-, intermediate-, and long-term outcomes of placebo, mechanical compression therapy, and invasive therapies (surgical and endovascular) were included. Quality ratings and evidence grading was performed. Random-effects models were used to compute summary estimates of effects.Results: We identified a total of 57 studies representing 105,878 enrolled patients, including 53 RCTs comprised of 10,034 patients. Among the RCTs, 16 were good quality, 28 were fair quality, and 9 were poor quality. Allocation concealment, double blinding, and reporting bias were inadequately addressed in 25 of 53 (47%), 46 of 53 (87%), and 15 of 53 (28.3%), respectively. Heterogeneity in therapies, populations, and/or outcomes prohibited meta-analysis of comparisons between different endovascular therapies and between endovascular intervention and placebo/compression. Meta-analysis evaluating venous stripping plus ligation (high ligation/stripping) compared with radiofrequency ablation revealed no difference in short-term bleeding (odds ratio [OR]=0.30, 95% CI -0.16 to 5.38, P=.43) or reflux recurrence at 1-2 years (OR=0.76, 95% CI 0.37-1.55, P=.44). Meta-analysis evaluating high ligation/stripping versus endovascular laser ablation revealed no difference in long-term symptom score (OR 0.02, 95% CI -0.19 to 0.23, P=.84) or quality of life at 2 years (OR 0.06, 95% CI -0.12 to 0.25, P=.50).Conclusions: The paucity of high-quality comparative effectiveness and safety data in LECVD is concerning given the overall rise in endovascular procedures. More high-quality studies are needed to determine comparative effectiveness and guide policy and practice. [ABSTRACT FROM AUTHOR]

Background: Many young investigators are interested in cardiovascular (CV) outcomes research; however, the current training experience of early investigators across the United States is uncertain.Methods: From April to November 2014, we surveyed mentees and mentors of early-stage CV outcomes investigators across the United States. We contacted successful grantees of government agencies, members of professional organizations, and trainees in CV outcomes training programs.Results: A total of 185 (of 662) mentees and 76 (of 541) mentors completed the survey. Mentees were equally split by sex; most had completed training >3 years before completing the survey and were clinicians. Mentors were more likely women, mostly ≥20 years posttraining, and at an associate/full professor rank. Mentors reported devoting more time currently to clinical work than when they were early in their career and mentoring 2-4 people simultaneously. More than 80% of mentees started training to become academicians and completed training with the same goal. More than 70% of mentees desired at least 50% research time in future jobs. More than 80% of mentors believed that future investigators would need more than 50% time dedicated to research. Most mentees (80%) were satisfied with their relationship with their mentor and reported having had opportunities to develop independently. Mentors more frequently than mentees reported that funding cutbacks had negatively affected mentees' ability to succeed (84% vs 58%). Across funding mechanisms, mentees were more optimistic than mentors about securing funding. Both mentees and mentors reported greatest preparedness for job/career satisfaction (79% for both) and publications (84% vs 92%) and least preparedness for future financial stability (48% vs 46%) and work-life balance (47% vs 42%).Conclusions: Survey findings may stimulate future discourse and research on how best to attract, train, and retain young investigators in CV outcomes research. Insights may help improve existing training programs and inform the design of new ones. [ABSTRACT FROM AUTHOR]

Background: Outcomes research training programs should prepare trainees to successfully compete for research funding. We examined how early-career investigators' prior and desired training aligns with recently funded cardiovascular (CV) outcomes research.Methods: We (1) reviewed literature to identify 13 core competency areas in CV outcomes research; (2) surveyed early-career investigators to understand their prior and desired training in each competency area; (3) examined recently funded grants commonly pursued by early-career outcomes researchers to ascertain available funding in competency areas; and (4) analyzed alignment between investigator training and funded research in each competency area. We evaluated 185 survey responses from early-career investigators (response rate 28%) and 521 funded grants from 2010 to 2014.Results: Respondents' prior training aligned with funded grants in the areas of clinical epidemiology, observational research, randomized controlled trials, and implementation/dissemination research. Funding in community-engaged research and health informatics was more common than prior training in these areas. Respondents' prior training in biostatistics and systematic review was more common than funded grants focusing on these specific areas. Respondents' desired training aligned similarly with funded grants, with some exceptions; for example, desired training in health economics/cost-effectiveness research was more common than funded grants in these areas. Restricting to CV grants (n=132) and National Heart, Lung, and Blood Institute-funded grants (n=170) produced similar results.Conclusions: Identifying mismatch between funded grants in outcomes research and early-career investigators' prior/desired training may help efforts to harmonize investigator interests, training, and funding. Our findings suggest a need for further consideration of how to best prepare early-career investigators for funding success. [ABSTRACT FROM AUTHOR]

Background: Primary prevention implantable cardioverter defibrillator (ICD) reduce all-cause mortality by reducing sudden cardiac death. There are conflicting data regarding whether patients with more advanced heart failure derive ICD benefit owing to the competing risk of nonsudden death.Methods: We performed a patient-level meta-analysis of New York Heart Association (NYHA) class II/III heart failure patients (left ventricular ejection fraction ≤35%) from 4 primary prevention ICD trials (MADIT-I, MADIT-II, DEFINITE, SCD-HeFT). Bayesian-Weibull survival regression models were used to assess the impact of NYHA class on the relationship between ICD use and mortality.Results: Of the 2,763 patients who met study criteria, 68% (n=1,867) were NYHA II and 52% (n=1,435) were randomized to an ICD. In a multivariable model including all study patients, the ICD reduced mortality (hazard ratio [HR] 0.65, 95% posterior credibility interval [PCI]) 0.40-0.99). The interaction between NYHA class and the ICD on mortality was significant (posterior probability of no interaction=.036). In models including an interaction term for the NYHA class and ICD, the ICD reduced mortality among NYHA class II patients (HR 0.55, PCI 0.35-0.85), and the point estimate suggested reduced mortality in NYHA class III patients (HR 0.76, PCI 0.48-1.24), although this was not statistically significant.Conclusions: Primary prevention ICDs reduce mortality in NYHA class II patients and trend toward reducing mortality in the heterogeneous group of NYHA class III patients. Improved risk stratification tools are required to guide patient selection and shared decision making among NYHA class III primary prevention ICD candidates. [ABSTRACT FROM AUTHOR]

Background The number of cardiac implantable electronic device (CIED) recalls and advisories has increased over the past 3 decades, yet no consensus exists on how to best manage patients with these CIEDs, partially because rates of complications from prophylactic replacement are unknown. Objective The purpose of this study was to establish rates of complications when recalled CIED generators are replaced prophylactically. Methods We searched MEDLINE and the Cochrane Controlled Trials Register for reports of prophylactic replacement of recalled CIED generators. Studies with <20 subjects were excluded. We then conducted a meta-analysis of qualifying studies to determine the rates of combined major complications, mortality, and reoperation. Results We identified 7 citations that met our inclusion criteria and reported ≥1 end-points of interest. Four were single center, and 3 were multicenter. Six studies collected data retrospectively (n = 1213) and 1 prospectively (n = 222). Using a random effects model to combine data from all included studies, the rate of major complications was 2.5% (95% confidence interval [CI] 1.0%-4.5%). Combining data from 6 studies reporting mortality and reoperation, the rates were 0.5% (95% CI 0.1%–0.9%) and 2.5% (95% CI 0.8%–4.5%), respectively. Conclusion Prophylactic replacement of recalled CIED generators is associated with a low mortality rate but nontrivial rates of other major complications similar to those reported when CIED generators are replaced for other reasons. Thus, when considering replacing a recalled CIED generator, known risks of elective generator replacement likely apply and can be weighed against risks associated with device failure. [ABSTRACT FROM AUTHOR]

Background: Atrial fibrillation (AF) guideline recommendations for antiarrhythmic drugs (AADs) are based on the effectiveness and safety of the AAD in patients with selected, concomitant heart disease. It is unknown to what extent these recommendations are being implemented in clinical practice. Methods: Using commercial health claims, patients with AF were identified and then categorized into mutually exclusive, guideline-established subgroups based on their most serious concurrent heart disease: heart failure, coronary artery disease (CAD), hypertension, and no heart disease. Antiarrhythmic drug use after the first AF encounter and the identified concurrent heart disease encounter was determined from prescription claims, and this was compared with guideline recommendations. Results: From January 2006 through December 2010, a total of 331,274 patients with AF aged <65 years were identified: 18%, heart failure; 23%, CAD; 33%, hypertension; and 25%, no heart disease. Of these, 78,877 (24%) patients filled ≥1 qualifying AAD prescription. The median age was 57 years (interquartile range 52-61), and 69% were male. A total of 74,191 patients had AADs after both the AF and concurrent heart disease encounters: 27% with heart failure, 25% with CAD, 21% with hypertension, and 19% with no heart disease. In the heart failure and CAD subgroups, 45% and 31% of AADs were inconsistent with first- or second-line guideline recommendations, respectively. Conclusion: More than one-third of the AADs used in patients with AF and CAD or heart failure did not conform to guideline recommendations. This highlights the potential need for increased clinician education and intervention to improve the safe use of AADs for AF management. [Copyright &y& Elsevier]

Background: Whether there is an optimal time to place an implantable cardioverter-defibrillator (ICD) more than 40 days after myocardial infarction (MI) in guideline-eligible patients is unknown. Objective: To evaluate the effect of time from MI to randomization on mortality, rehospitalizations, and complications. Methods: Individual data on patients enrolled in 9 primary prevention ICD trials were provided. Clinical trials were eligible for the current analysis if they enrolled patients with an MI more than 40 days prior to randomization to primary prevention ICD therapy vs usual care: Multicenter Automatic Defibrillator Implantation Trial I, Multicenter UnSustained Tachyardia Trial, Multicenter Automatic Defibrillator Implantation Trial II, and Sudden Cardiac Death in Heart Failure Trial. Results: ICD recipients died less frequently than nonrecipients at 5 years across all subgroups of time from MI to randomization. In unadjusted Cox proportional hazards regression, a survival benefit was evident in most subgroups. Adjusted Bayesian Weibull survival modeling yielded hazard ratio (HR) 0.50, 95% posterior credible interval (PCI) 0.20–1.25 41–180 days after MI; HR 0.98, 95% PCI 0.37–2.37 181–365 days after MI; HR 0.22, 95% PCI 0.07–0.59>1–2 years after MI; HR 0.42, 95% PCI 0.17–0.90>2–5 years after MI; HR 0.55, 95% PCI 0.25–1.15>5–10 years after MI; and HR 0.48, 95% PCI 0.20–1.02>10 years after MI. There was no evidence of an interaction between time from MI and all-cause mortality, rehospitalizations, or complications. Conclusions: In this meta-analysis, there was scant evidence that the efficacy of primary prevention ICD therapy depends on time to implantation more than 40 days after MI. Similarly, there was no evidence that the risks of rehospitalizations or complications depend on time more than 40 days after MI. [Copyright &y& Elsevier]

Sudden cardiac arrest (SCA) is one of the most impactful public health problems in the United States. Despite the progress made in reducing the number of cardiac deaths, the incidence of sudden cardiac death remains high. Studies of life-saving interventions for prevention and treatment of SCA, like β-blockers, aldosterone antagonists, implantable cardioverter defibrillator therapy, automated external defibrillators, and cardiopulmonary resuscitation, have brought to light substantial underutilization, variations in care, and disparities. Thus, a comprehensive systems-based approach to addressing these gaps in care should be implemented. In addition to educating stakeholders about SCA and its prevention and developing tools that could help physicians identify patients who could benefit from primary prevention of SCA, robust performance measures with strong, evidence-based association between process performance and patient outcomes are needed. In this article, we review the burden of SCA and highlight the need to develop performance measures related to the prevention and treatment of SCA. [Copyright &y& Elsevier]

Abstract: Background/Objectives: Timely identification of cardiac ischemia is critical in patients with acute coronary syndrome (ACS). The first test is often the standard, resting 12-lead ECG. Given its limitations, signal analysis enhancements have been proposed. We summarize the published evidence for commercially available ECG-based signal analysis technologies. Methods: This is a systematic review of the English-language published literature. Results: Published evidence meeting inclusion criteria was available for two devices: PRIME ECG and LP 3000. Meta-analysis of eight studies estimated a 68.4% sensitivity (95% CI, 35.1%–89.7%) and 91.4% specificity (CI, 83.6%–95.7%) for the PRIME ECG, compared with 40.5% sensitivity (CI, 19.6%–65.5%) and 95.0% specificity (CI, 87.9%–98.0%) for the standard 12-lead ECG. Conclusions: Existing evidence is insufficient to confidently inform the appropriate use of ECG-based signal analysis technologies for detecting ischemia or infarct in ACS. Further research is needed to determine in what circumstances, if any, these devices might precede, replace, or add to the standard ECG in test strategies for detecting ischemia or infarct in ACS. [Copyright &y& Elsevier]

Sudden cardiac arrest (SCA) is the most common cause of death in the United States. Despite national guidelines, patients at risk for SCA often fail to receive evidence-based therapies. Racial and ethnic minorities and women are at particularly high risk for undertreatment. To address the persistent challenges in improving the quality of care for SCA, the Duke Center for the Prevention of Sudden Cardiac Death at the Duke Clinical Research Institute (Durham, NC) reconvened the Sudden Cardiac Arrest Thought Leadership Alliance. Experts from clinical cardiology, cardiac electrophysiology, health policy and economics, the US Food and Drug Administration, the Centers for Medicare and Medicaid Services, the Agency for Health Care Research and Quality, and device and pharmaceutical manufacturers discussed the development of SCA educational tools for patients and providers, mechanisms of implementing successful tools to help providers identify patients in their practice at risk for SCA, disparities in SCA prevention, and performance measures related to SCA care. This article summarizes the discussions held at this meeting. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: This study was designed to determine if physicians’ attitudes and recommendations surrounding implantable cardioverter-defibrillators (ICDs) are regionally associated with ICD use. Methods and Results: A national sample of 9969 members of the American College of Cardiology was surveyed electronically. Responses were merged with rates of ICD implantation from the National Cardiovascular Data Registry. Multivariable regression was used to assess trends between regional use and responses. We received 1210 responses (12%) and used 1124 after exclusions. Across regions, physicians were equally likely to recommend ICDs to males or females with ischemic (∼99% for both; P = NS) or nonischemic cardiomyopathy (85 vs. 88% P = 0.85). Significant increasing trends in the probability recommending ICD therapy were found when the patient was “frail” (21% to 32%; P = .03) or had a life expectancy <1 year (5% to 10%; P = .05). These differences were not associated with attitudes toward ICDs. Conclusions: Independent of variations in physicians’ attitudes towards ICDs, physicians in regions of low ICD use are not less likely to recommend ICDs in situations clearly supported by guidelines while those in regions of high ICD use are more likely to recommend ICDs to patients who might have limited benefit. [Copyright &y& Elsevier]

Background: More than 80% of sudden cardiac deaths (SCDs) occur in patients ≥65 years old; the cost-effectiveness of implantable cardioverter defibrillator (ICD) therapy in older patients remains unclear. We sought to examine the cost-effectiveness of ICD therapy in at-risk patients ≥65 years old. Methods: We developed a Markov model to evaluate lifetime costs and benefits of ICD therapy compared with optimal medical therapy in patients ≥65 years of age with left ventricular dysfunction. Data were derived from the literature and existing clinical trials of primary prevention of SCD. Outcome measures included life years, quality-adjusted life years, costs, and incremental cost-effectiveness. Results: Benefits and costs of ICD therapy in older individuals varied widely by clinical-trial population. In the 5 trials considered, for patients ≥65 years of age, ICDs demonstrated a life expectancy benefit compared with control therapy (incremental cost-effectiveness ratios ranging from $37,031-$138,458 per quality-adjusted life year). For 75-year-old patients, the findings were qualitatively similar, although cost-effectiveness was reduced in all trial populations. In sensitivity analyses, cost-effectiveness of ICD therapy in older individuals depended upon the trial population, quality of life, device cost, and frequency of generator replacement. Sensitivity analyses on other variables did not change the results substantially. Conclusions: The cost-effectiveness of ICD therapy for primary prevention in older patients varies widely among trials. Given an aging US population and the high risk of SCD in these individuals, further studies of ICD therapy and their cost-effectiveness—specifically in older patients—are needed. [Copyright &y& Elsevier]

The article focuses on guideline-driven therapies intended on stopping sudden cardiac death (SCD). It states that one therapy to prevent SCD is the implantable cardioverter defrillator (ICD). It mentions that while ICD is cost effective and beneficial, most patients at risk of SCD are not receiving ICD. It examines results of a think tank by the Duke Center for the Prevention of SCD at Duke Clinical Research Institute in Durham, North Carolina.

Accurate and timely prediction of sudden cardiac death (SCD) is a necessary prerequisite for effective prevention and therapy. Although the largest number of SCD events occurs in patients without overt heart disease, there are currently no tests that are of proven predictive value in this population. Efforts in risk stratification for SCD have focused primarily on predicting SCD in patients with known structural heart disease. Despite the ubiquity of tests that have been purported to predict SCD vulnerability in such patients, there is little consensus on which test, in addition to the left ventricular ejection fraction, should be used to determine which patients will benefit from an implantable cardioverter defibrillator. On July 20 and 21, 2006, a group of experts representing clinical cardiology, cardiac electrophysiology, biostatistics, economics, and health policy were joined by representatives of the US Food and Drug administration, Centers for Medicare Services, Agency for Health Research and Quality, the Heart Rhythm Society, and the device and pharmaceutical industry for a round table meeting to review current data on strategies of risk stratification for SCD, to explore methods to translate these strategies into practice and policy, and to identify areas that need to be addressed by future research studies. The meeting was organized by the Duke Center for the Prevention of SCD at the Duke Clinical Research Institute and was funded by industry participants. This article summarizes the presentations and discussions that occurred at that meeting. [Copyright &y& Elsevier]

Although current evidence supporting a more precise strategy for identifying patients at highest risk for sudden cardiac death (SCD) is sparse, strategies for translating existing and future evidence into clinical practice and policy are needed today. A great many unanswered questions exist. Examples include the following: At what level of risk for SCD should we pursue further testing or therapy? How should clinical strategies ethically and economically balance alternative outcomes? How can we best translate optimal strategies into clinical practice so as to prevent tomorrow''s SCDs? On July 20 and 21, 2006, a group of individuals with expertise in clinical cardiovascular medicine, biostatistics, economics, and health policy was joined by government (Food and Drug Administration; Centers for Medicare and Medicaid Services; National Heart, Lung, and Blood Institute; Agency for Healthcare Research and Quality), professional societies (Heart Rhythm Society), and industry to discuss strategies for risk assessment and prevention of SCD. The meeting was organized by the Duke Center for the Prevention of Sudden Cardiac Death and the Duke Clinical Research Institute. This article, the second of 2 documents, summarizes the policy discussions of that meeting, discusses an analytic framework for evaluating the risks and benefits associated with SCD prevention and risk stratification, and addresses the translation of SCD risk assessment strategies into practice and policy. [Copyright &y& Elsevier]

Background: Several studies based on claims data have reported underutilization of evidence-based heart failure (HF) therapies. The degree to which these estimates fail to account for therapeutic contraindications is unclear. Methods: We identified patients with HF and left ventricular ejection fraction ≤45% seen between January 1, 2010, and July 1, 2010, at a tertiary care Veterans Affairs Medical Center. Medical records were abstracted to evaluate utilization of and contraindications to β-blocker, angiotensin-converting enzyme inhibitor, aldosterone antagonist, anticoagulation for atrial fibrillation, implantable cardioverter-defibrillator, and cardiac resynchronization therapies. Results: Of the 178 patients with HF and an ejection fraction ≤45%, 78 (44%) received every guideline-recommended therapy. After accounting for medical contraindications, 77 (72%) of 107 patients received every guideline-recommended therapy. Adherence to recommendations for β-blocker (98%), angiotensin-converting enzyme inhibitor/angiotensin blocker (95%), and anticoagulation (97%) were better than adherence to implantable cardioverter-defibrillator (82%), cardiac resynchronization therapy (59%), or aldosterone antagonist (51%) recommendations. In adjusted analysis, lower New York Heart Association functional class and care by a cardiologist were associated with improved guideline adherence (P < .001). Conclusions: Many patients with HF have therapeutic contraindications, and a failure to account for these may lead to a large underestimation of the true guideline adherence rates. [ABSTRACT FROM AUTHOR]

Background: A recent review evaluated the comparative effectiveness of angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin II receptor blockers (ARBs) in patients with or at high risk for stable ischemic heart disease (IHD). The prioritization of future research needs has customarily been an informal process that is not responsive to the needs of all relevant stakeholders. Methods: As part of the Agency for Healthcare Research and Quality Effective Healthcare Program, the Duke Evidence-Based Practice Center engaged a diverse stakeholder group in 3 exercises designed to prioritize future research needs pertaining to the comparative effectiveness of ACE-I/ARB in patients with stable IHD. Results: Our stakeholders prioritized the following areas of research pertaining to the comparative effectiveness of ACE-I/ARB in stable IHD: (1) strategies to enhance greater evidence-based use, (2) impact of adherence on effectiveness or harms, (3) impact of comorbidities on effectiveness or harms, (4) medication impact on patient quality of life, (5) impact of demographic differences on effectiveness or harms, and (6) medication impact on incidence of new diagnoses. This project also yielded suggestions regarding potential study designs to address these future research needs. Conclusions: Our stakeholders prioritized research designed to facilitate (1) tailored ACE-I/ARB treatment based on individual patient characteristics and (2) implementation of ACE-I/ARB use among patients most likely to benefit. With respect to suggested study designs, it was felt that analysis of existing data would sufficiently address many of the top-tier future research needs (FRNs). [ABSTRACT FROM AUTHOR]

Sudden cardiac arrest (SCA) is the most common cause of death in the Unites States. Despite its major impact on public health, significant challenges exist at the patient, provider, public, and policy levels with respect to raising more widespread awareness and understanding of SCA risks, identifying patients at risk for SCA, addressing barriers to SCA care, and eliminating disparities in SCA care and outcomes. To address many of these challenges, the Duke Center for the Prevention of Sudden Cardiac Death at the Duke Clinical Research Institute (Durham, NC) held a think tank meeting on December 7, 2009, convening experts on this issue from clinical cardiology, cardiac electrophysiology, health policy and economics, the US Food and Drug Administration, the Centers for Medicare and Medicaid Services, the Agency for Health Care Research and Quality, and device and pharmaceutical manufacturers. The specific goals of the meeting were to examine existing educational tools on SCA for patients, health care providers, and the public and explore ways to enhance and disseminate these tools; to propose a framework for improved identification of patients at risk of SCA; and to review the latest data on disparities in SCA care and explore ways to reduce these disparities. This article summarizes the discussions that occurred at the meeting. [ABSTRACT FROM AUTHOR]

The need for consistent and current data describing the true incidence of sudden cardiac arrest (SCA) and/or sudden cardiac death (SCD) was highlighted during the most recent Sudden Cardiac Arrest Thought Leadership Alliance''s (SCATLA) Think Tank meeting of national experts with broad representation of key stakeholders, including thought leaders and representatives from the American College of Cardiology, American Heart Association, and the Heart Rhythm Society. As such, to evaluate the true magnitude of this public health problem, we performed a systematic literature search in MEDLINE using the MeSH headings, “death, sudden” OR the terms “sudden cardiac death” OR “sudden cardiac arrest” OR “cardiac arrest” OR “cardiac death” OR “sudden death” OR “arrhythmic death.” Study selection criteria included peer-reviewed publications of primary data used to estimate SCD incidence in the U.S. We used Web of Science''s Cited Reference Search to evaluate the impact of each primary estimate on the medical literature by determining the number of times each “primary source” has been cited. The estimated U.S. annual incidence of SCD varied widely from 180,000 to >450,000 among 6 included studies. These different estimates were in part due to different data sources (with data age ranging from 1980 to 2007), definitions of SCD, case ascertainment criteria, methods of estimation/extrapolation, and sources of case ascertainment. The true incidence of SCA and/or SCD in the U.S. remains unclear, with a wide range in the available estimates that are badly dated. As reliable estimates of SCD incidence are important for improving risk stratification and prevention, future efforts are clearly needed to establish uniform definitions of SCA and SCD and then to prospectively and precisely capture cases of SCA and SCD in the overall U.S. population. [Copyright &y& Elsevier]