Externalized conductors and electrical dysfunction in transvenous ventricular leads: Results of the Cardiac Lead Assessment Study.

Background: The Cardiac Lead Assessment Study (CLAS) was a large prospective, multicenter, international postmarket surveillance study conducted at 45 sites. Objective: The purpose of CLAS was to examine the prevalence and incidence of externalized conductors and electrical dysfunction in subjects with selected St. Jude Medical defibrillator and left ventricular leads. Methods: Cinefluoroscopy was used to determine the presence of externalized conductors at enrollment and at 12-, 24-, and 36-month follow-up visits. Lead electrical measurements were collected systematically. Results: The study enrolled 2216 subjects with a total of 2847 study leads. The prevalence of externalized conductors through 36 months for Riata leads was 30.9%, Riata ST leads 12.6%, Durata leads 0.5%, and QuickSite/QuickFlex leads 4.7%. The prevalence of electrical dysfunction through 36 months for Riata was 4.0%, Riata ST 3.3%, Durata 2.4%, and QuickSite/QuickFlex 0.3%. In Riata and Riata ST leads with externalized conductors, there was a low risk of electrical dysfunction. None of the Durata or QuickSite/QuickFlex leads with externalized conductors developed electrical dysfunction. There was no evidence of an electrical short in a high-voltage shocking circuit leading to failed shock. Conclusion: A high prevalence of externalized conductors was found in Riata and Riata ST defibrillator leads, with a higher risk of externalization for 8F Riata leads than for 7F Riata ST leads. The 98% reduction in prevalence of externalized conductors in Durata leads compared to Riata/Riata ST leads confirms that the design improvements culminating in Durata leads significantly improved abrasion resistance and durability.

Arrhythmias in Female Patients: Incidence, Presentation and Management.

There is a growing appreciation for differences in epidemiology, treatment, and outcomes of cardiovascular conditions by sex. Historically, cardiovascular clinical trials have under-represented females, but findings have nonetheless been applied to clinical care in a sex-agnostic manner. Thus, much of the collective knowledge about sex-specific cardiovascular outcomes result from post hoc and secondary analyses. In some cases, these investigations have revealed important sex-based differences with implications for optimizing care for female patients with arrhythmias. This review explores the available evidence related to cardiac arrhythmia care among females, with emphasis on areas in which important sex differences are known or suggested. Considerations related to improving female enrollment in clinical trials as a way to establish more robust clinical evidence for the treatment of females are discussed. Areas of remaining evidence gaps are provided, and recommendations for areas of future research and specific action items are suggested. The overarching goal is to improve appreciation for sex-based differences in cardiac arrhythmia care as 1 component of a comprehensive plan to optimize arrhythmia care for all patients.

Management of Atrial Fibrillation in Patients 75 Years and Older: JACC State-of-the-Art Review.

The prevalence of atrial fibrillation (AF) is increasing as the population ages. AF treatment-related complications also increase markedly in older adults (defined as ≥75 years of age for this review). The older AF population has a high risk of stroke, bleeding, and death. Syncope and fall-related injuries are the most common reasons for nonprescription of oral anticoagulation (OAC), and are more common in older adults when OACs are used with antiarrhythmic drugs. Digoxin may be useful for rate control, but associations with increased mortality limit its use. Beyond rate and rhythm control considerations, stroke prophylaxis is critical to AF management, and the benefits of direct OACs, compared with warfarin, extend to older adults. Invasive procedures such as AF catheter ablation, pacemaker implantation/atrioventricular junction ablation, and left atrial appendage occlusion may be useful in appropriately selected cases. However, older adults have generally been under-represented in clinical trials.

Management of Atrial Fibrillation in Older Patients by Morbidity Burden: Insights From Get With The Guidelines-Atrial Fibrillation.

Background Knowledge is scarce regarding how multimorbidity is associated with therapeutic decisions regarding oral anticoagulants (OACs) in patients with atrial fibrillation. Methods and Results We conducted a cross-sectional study of hospitalized patients with atrial fibrillation using the Get With The Guidelines-Atrial Fibrillation registry from 2013 to 2019. We identified patients ≥65 years and eligible for OAC therapy. Using 16 available comorbidity categories, patients were stratified by morbidity burden. A multivariable logistic regression model was used to determine the odds of receiving OAC prescription at discharge by morbidity burden. We included 34 174 patients with a median (interquartile range) age of 76 (71-83) years, 56.6% women, and 41.9% were not anticoagulated at admission. Of these patients, 38.6% had 0 to 2 comorbidities, 50.7% had 3 to 5 comorbidities, and 10.7% had ≥6 comorbidities. The overall discharge OAC prescription was high (85.6%). The prevalence of patients with multimorbidity increased from 59.7% in 2014 to 64.3% in 2019 (P trend=0.002). Using 0 to 2 comorbidities as the reference, the adjusted odds ratio (95% CI) of OAC prescription were 0.93 (0.82, 1.05) for patients with 3 to 5 comorbidities and 0.72 (0.60, 0.86) for patients with ≥6 comorbidities. In those with ≥6 comorbidities, the most common reason for nonprescription of OACs were frequent falls/frailty (31.0%). Conclusions In a contemporary quality-of-care database of hospitalized patients with atrial fibrillation eligible for OAC therapy, multimorbidity was common. A higher morbidity burden was associated with a lower odds of OAC prescription. This highlights the need for interventions to improve adherence to guideline-recommended anticoagulation in multimorbid patients with atrial fibrillation.

Economic value and cost-effectiveness of biventricular versus right ventricular pacing: results from the BLOCK-HF study.

Aims: The Biventricular vs Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block (BLOCK-HF) demonstrated that biventricular (BiV) pacing resulted in better clinical and structural outcomes compared to right ventricular (RV) pacing in patients with atrioventricular (AV) block and reduced left ventricular ejection fraction (LVEF; ≤50%). This study investigated the cost-effectiveness of BiV vs RV pacing in the patient population enrolled in the BLOCK-HF trial. Methods: All-cause mortality, New York Heart Association (NYHA) Class distribution over time, and NYHA-specific heart failure (HF)-related healthcare utilization rates were predicted using statistical models based on BLOCK-HF patient data. A proportion-in-state model calculated cost-effectiveness from the Medicare payer perspective. Results: The predicted patient survival was 6.78 years with RV and 7.52 years with BiV pacing, a 10.9% increase over lifetime. BiV pacing resulted in 0.41 more quality-adjusted life years (QALYs) compared to RV pacing, at an additional cost of $12,537. The "base-case" incremental cost-effectiveness ratio (ICER) was $30,860/QALY gained. Within the clinical sub-groups, the highest observed ICER was $43,687 (NYHA Class I). Patients receiving combined BiV pacing and defibrillation (BiV-D) devices were projected to benefit more (0.84 years gained) than BiV pacemaker (BiV-P) recipients (0.49 years gained), compared to dual-chamber pacemakers. Conclusions: BiV pacing in AV block patients improves survival and attenuates HF progression compared to RV pacing. ICERs were consistently below the US acceptability threshold ($50,000/QALY). From a US Medicare perspective, the additional up-front cost associated with offering BiV pacing to the BLOCK-HF patient population appears justified.

The effect of a monetary incentive for administrative assistants on the survey response rate: a randomized controlled trial.

BACKGROUND: There is sufficient evidence that monetary incentives are effective in increasing survey response rates in the general population as well as with physicians. The objective of this study was to assess the impact of a monetary incentive intended for administrative assistants on the survey response rate of physicians in leadership positions. METHODS: This was an ancillary study to a national survey of chairs of academic Departments of Medicine in the United States about measuring faculty productivity. We randomized survey participants to receive or not receive a $5 gift card enclosed in the survey package. The cover letter explained that the gift card was intended for the administrative assistants as a "thank you for their time." We compared the response rates between the 2 study arms using the Chi-square test. RESULTS: Out of 152 participants to whom survey packages were mailed to, a total of 78 responses were received (51 % response rate). The response rates were 59 % in the incentive arm and 46 % in the no incentive arm. The relative effect of the incentive compared to no monetary incentive was borderline statistically significant (relative risk (RR) = 1.36, 95 % confidence interval (CI) 0.99 to 1.87; p = 0.055). CONCLUSION: Monetary incentives intended for administrative assistants likely increase the response rate of physicians in leadership positions.

Assessment of faculty productivity in academic departments of medicine in the United States: a national survey.

BACKGROUND: Faculty productivity is essential for academic medical centers striving to achieve excellence and national recognition. The objective of this study was to evaluate whether and how academic Departments of Medicine in the United States measure faculty productivity for the purpose of salary compensation. METHODS: We surveyed the Chairs of academic Departments of Medicine in the United States in 2012. We sent a paper-based questionnaire along with a personalized invitation letter by postal mail. For non-responders, we sent reminder letters, then called them and faxed them the questionnaire. The questionnaire included 8 questions with 23 tabulated close-ended items about the types of productivity measured (clinical, research, teaching, administrative) and the measurement strategies used. We conducted descriptive analyses. RESULTS: Chairs of 78 of 152 eligible departments responded to the survey (51% response rate). Overall, 82% of respondents reported measuring at least one type of faculty productivity for the purpose of salary compensation. Amongst those measuring faculty productivity, types measured were: clinical (98%), research (61%), teaching (62%), and administrative (64%). Percentages of respondents who reported the use of standardized measurements units (e.g., Relative Value Units (RVUs)) varied from 17% for administrative productivity to 95% for research productivity. Departments reported a wide variation of what exact activities are measured and how they are monetarily compensated. Most compensation plans take into account academic rank (77%). The majority of compensation plans are in the form of a bonus on top of a fixed salary (66%) and/or an adjustment of salary based on previous period productivity (55%). CONCLUSION: Our survey suggests that most academic Departments of Medicine in the United States measure faculty productivity and convert it into standardized units for the purpose of salary compensation. The exact activities that are measured and how they are monetarily compensated varied substantially across departments.

B-type natriuretic peptide assessment in ambulatory heart failure patients: insights from IMPROVE HF.

BACKGROUND: B-type natriuretic peptide (BNP) levels provide diagnostic and prognostic information in heart failure. This study determined the frequency of BNP assessment and analyzed demographic characteristics, clinical variables and the utilization of guideline-recommended heart failure therapies by BNP level in outpatients with reduced left ventricular ejection fraction (LVEF). METHODS AND RESULTS: The IMPROVE HF registry (The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) is a prospective cohort study of patients at least 18 years of age with a LVEF 35% or less and chronic heart failure or previous myocardial infarction (MI) presenting to cardiology and multispecialty practices. The medical records of 15,381 patients were reviewed. BNP was measured in 4213 (27.4%) patients and the median plasma BNP level was 384 pg/ml (interquartile range 158-877 pg/ml). Patients were stratified by plasma BNP measurements into the following tertiles: 219 pg/ml or less, more than 219 to 649 pg/ml, and more than 649 pg/ml. Jugular venous distension, pedal edema, rales and systolic murmur on physical examination and elevated renal function parameters were associated with higher BNP levels. BNP assessment and elevated BNP levels were not associated with greater use of any of the quality of care measures. However, patients with a BNP in the top tertile were less likely to be treated with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers or aldosterone antagonists compared with patients with a BNP in the bottom tertile. CONCLUSION: Among practices participating in IMPROVE HF, BNP was not measured in most outpatients with reduced LVEF and chronic heart failure or previous MI. BNP assessment or the BNP level in patients with recorded measurements, with few exceptions, did not impact the utilization of guideline-recommended therapies.

Relation of obesity to recurrence rate and burden of atrial fibrillation.

Obesity is associated with new-onset atrial fibrillation (AF). However, the effect of obesity on AF recurrence or burden has not been studied. The aim of this study was to investigate the relation between AF recurrence, AF burden, and body mass index (BMI). A limited-access data set from the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) trial provided by the National Heart, Lung, and Blood Institute was used. Statistical analysis was done with a generalized linear mixed model. In 2,518 patients who had BMIs recorded, higher BMI was associated with a higher number of cardioversions (odds ratio [OR] 1.017, 95% confidence interval [CI] 1.005 to 1.029 for a BMI increase of 1 kg/m(2); OR 1.088, 95% CI 1.024 to 1.155 for a BMI increase of 5 kg/m(2); OR 1.183, 95% CI 1.049 to 1.334 for a BMI increase of 10 kg/m(2); p = 0.006 for each). Increased BMI was also associated with a higher likelihood of being in AF on follow-up (OR 1.020, 95% CI 1.002 to 1.038 per 1 kg/m(2) increased BMI, p = 0.0283; OR 1.104, 95% CI 1.011 to 1.205 per 5 kg/m(2) increased BMI, p = 0.0283; OR 1.218, 95% CI 1.021 to 1.452 per 10 kg/m(2) increased BMI, p = 0.0283). In a multivariate analysis, left atrial size but not BMI was an independent predictor of AF recurrence and AF burden. Because left atrial size was correlated with BMI, the effect of BMI on AF can be likely explained by greater left atrial size in subjects with higher BMIs. In conclusion, obesity is associated with a higher incidence of recurrence of AF and greater AF burden.

Preventing tomorrow's sudden cardiac death today: part II: Translating sudden cardiac death risk assessment strategies into practice and policy.

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.

Why cardioverter-defibrillator implantation might not be the best idea for your elderly patient.

Over the last decade, implantable cardioverter-defibrillators (ICDs) have become a part of mainstream clinical practice, with improvements in survival in a broad range of patients. Given the overall limited life expectancy of elderly patients, their frequent comorbidities, and the complications associated with ICD implantation, it may not be reasonable to expect results with ICD implantation in the elderly to be comparable to that found in the clinical trials. In this paper, the authors review the available scientific literature and discuss why mainstream ICD use in the elderly may not be advisable.