Heart Disease and Stroke Statistics-2023 Update: A Report From the American Heart Association.

BACKGROUND: The American Heart Association, in conjunction with the National Institutes of Health, annually reports the most up-to-date statistics related to heart disease, stroke, and cardiovascular risk factors, including core health behaviors (smoking, physical activity, diet, and weight) and health factors (cholesterol, blood pressure, and glucose control) that contribute to cardiovascular health. The Statistical Update presents the latest data on a range of major clinical heart and circulatory disease conditions (including stroke, congenital heart disease, rhythm disorders, subclinical atherosclerosis, coronary heart disease, heart failure, valvular disease, venous disease, and peripheral artery disease) and the associated outcomes (including quality of care, procedures, and economic costs). METHODS: The American Heart Association, through its Epidemiology and Prevention Statistics Committee, continuously monitors and evaluates sources of data on heart disease and stroke in the United States to provide the most current information available in the annual Statistical Update with review of published literature through the year before writing. The 2023 Statistical Update is the product of a full year's worth of effort in 2022 by dedicated volunteer clinicians and scientists, committed government professionals, and American Heart Association staff members. The American Heart Association strives to further understand and help heal health problems inflicted by structural racism, a public health crisis that can significantly damage physical and mental health and perpetuate disparities in access to health care, education, income, housing, and several other factors vital to healthy lives. This year's edition includes additional COVID-19 (coronavirus disease 2019) publications, as well as data on the monitoring and benefits of cardiovascular health in the population, with an enhanced focus on health equity across several key domains. RESULTS: Each of the chapters in the Statistical Update focuses on a different topic related to heart disease and stroke statistics. CONCLUSIONS: The Statistical Update represents a critical resource for the lay public, policymakers, media professionals, clinicians, health care administrators, researchers, health advocates, and others seeking the best available data on these factors and conditions.

Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association.

BACKGROUND: The American Heart Association, in conjunction with the National Institutes of Health, annually reports the most up-to-date statistics related to heart disease, stroke, and cardiovascular risk factors, including core health behaviors (smoking, physical activity, diet, and weight) and health factors (cholesterol, blood pressure, and glucose control) that contribute to cardiovascular health. The Statistical Update presents the latest data on a range of major clinical heart and circulatory disease conditions (including stroke, congenital heart disease, rhythm disorders, subclinical atherosclerosis, coronary heart disease, heart failure, valvular disease, venous disease, and peripheral artery disease) and the associated outcomes (including quality of care, procedures, and economic costs). METHODS: The American Heart Association, through its Statistics Committee, continuously monitors and evaluates sources of data on heart disease and stroke in the United States to provide the most current information available in the annual Statistical Update. The 2022 Statistical Update is the product of a full year's worth of effort by dedicated volunteer clinicians and scientists, committed government professionals, and American Heart Association staff members. This year's edition includes data on the monitoring and benefits of cardiovascular health in the population and an enhanced focus on social determinants of health, adverse pregnancy outcomes, vascular contributions to brain health, and the global burden of cardiovascular disease and healthy life expectancy. RESULTS: Each of the chapters in the Statistical Update focuses on a different topic related to heart disease and stroke statistics. CONCLUSIONS: The Statistical Update represents a critical resource for the lay public, policymakers, media professionals, clinicians, health care administrators, researchers, health advocates, and others seeking the best available data on these factors and conditions.

Research Needs and Priorities for Catheter Ablation of Atrial Fibrillation: A Report From a National Heart, Lung, and Blood Institute Virtual Workshop.

Catheter ablation has brought major advances in the management of patients with atrial fibrillation (AF). As evidenced by multiple randomized trials, AF catheter ablation can reduce the risk of recurrent AF and improve quality of life. In some studies, AF ablation significantly reduced cardiovascular hospitalizations. Despite the existing data on AF catheter ablation, numerous knowledge gaps remain concerning this intervention. This report is based on a recent virtual workshop convened by the National Heart, Lung, and Blood Institute to identify key research opportunities in AF ablation. We outline knowledge gaps related to emerging technologies, the relationship between cardiac structure and function and the success of AF ablation in patient subgroups in whom clinical benefit from ablation varies, and potential platforms to advance clinical research in this area. This report also considers the potential value and challenges of a sham ablation randomized trial. Prioritized research opportunities are identified and highlighted to empower relevant stakeholders to collaborate in designing and conducting effective, cost-efficient, and transformative research to optimize the use and outcomes of AF ablation.

Wearable Cardioverter-Defibrillator after Myocardial Infarction.

BACKGROUND: Despite the high rate of sudden death after myocardial infarction among patients with a low ejection fraction, implantable cardioverter-defibrillators are contraindicated until 40 to 90 days after myocardial infarction. Whether a wearable cardioverter-defibrillator would reduce the incidence of sudden death during this high-risk period is unclear. METHODS: We randomly assigned (in a 2:1 ratio) patients with acute myocardial infarction and an ejection fraction of 35% or less to receive a wearable cardioverter-defibrillator plus guideline-directed therapy (the device group) or to receive only guideline-directed therapy (the control group). The primary outcome was the composite of sudden death or death from ventricular tachyarrhythmia at 90 days (arrhythmic death). Secondary outcomes included death from any cause and nonarrhythmic death. RESULTS: Of 2302 participants, 1524 were randomly assigned to the device group and 778 to the control group. Participants in the device group wore the device for a median of 18.0 hours per day (interquartile range, 3.8 to 22.7). Arrhythmic death occurred in 1.6% of the participants in the device group and in 2.4% of those in the control group (relative risk, 0.67; 95% confidence interval [CI], 0.37 to 1.21; P=0.18). Death from any cause occurred in 3.1% of the participants in the device group and in 4.9% of those in the control group (relative risk, 0.64; 95% CI, 0.43 to 0.98; uncorrected P=0.04), and nonarrhythmic death in 1.4% and 2.2%, respectively (relative risk, 0.63; 95% CI, 0.33 to 1.19; uncorrected P=0.15). Of the 48 participants in the device group who died, 12 were wearing the device at the time of death. A total of 20 participants in the device group (1.3%) received an appropriate shock, and 9 (0.6%) received an inappropriate shock. CONCLUSIONS: Among patients with a recent myocardial infarction and an ejection fraction of 35% or less, the wearable cardioverter-defibrillator did not lead to a significantly lower rate of the primary outcome of arrhythmic death than control. (Funded by the National Institutes of Health and Zoll Medical; VEST ClinicalTrials.gov number, NCT01446965 .).

Spatial characterization of the tachycardia circuit of atrioventricular nodal re-entrant tachycardia.

AIMS: The exact circuit of atrioventricular nodal re-entrant tachycardia (AVNRT) remains elusive. To assess the location and dimensions of the AVNRT circuit. METHODS AND RESULTS: Both typical and atypical AVNRT were induced at electrophysiology study of 14 patients. We calculated the activation time of the fast and slow pathways, and consequently, the length of the slow pathway, by assuming an average conduction velocity of 0.04 mm/ms in the nodal area. The distance between the compact atrioventricular node and the slow pathway ablating electrode was measured on three-dimensionally reconstructed fluoroscopic images obtained in diastole and systole. We also measured the length of the histologically discrete right inferior nodal extension in 31 human hearts. The length of the slow pathway was calculated to be 10.8 ± 1.3 mm (range 8.2-12.8 mm). The distance from the node to the ablating electrode was measured in five patients 17.0 ± 1.6 mm (range 14.9-19.2 mm) and was consistently longer than the estimated length of the slow pathway (P < 0.001). The length of the right nodal inferior extension in histologic specimens was 8.1 ± 2.3 mm (range 5.3-13.7 mm). There were no statistically significant differences between these values and the calculated slow pathway lengths. CONCLUSION: Successful ablation affects the tachycardia circuit without necessarily abolishing slow conduction, probably by interrupting the circuit at the septal isthmus.

Risk Stratification for Sudden Cardiac Death After Myocardial Infarction.

Sudden cardiac death (SCD) accounts for ∼50% of mortality after myocardial infarction (MI). Most SCDs result from ventricular tachyarrhythmias, and the tachycardias that precipitate cardiac arrest result from multiple mechanisms. As a result, it is highly unlikely that any single test will identify all patients at risk for SCD. Current guidelines for use of implantable cardioverter-defibrillators (ICDs) to prevent SCD are based primarily on measurement of left ventricular ejection fraction (LVEF). Although reduced LVEF is associated with increased total cardiac mortality after MI, the focus of current guidelines on LVEF omits ∼50% of patients who die suddenly. In addition, there is no evidence of a mechanistic link between reduced LVEF and arrhythmias. Thus, LVEF is neither sensitive nor specific as a tool for post-MI risk stratification. Newer tests to screen for predisposition to ventricular arrhythmias and SCD examine abnormalities of ventricular repolarization, autonomic nervous system function, and electrical heterogeneity. These tests, as well as older methods such as programmed stimulation, the signal-averaged electrocardiogram, and spontaneous ventricular ectopy, do not perform well in patients with LVEF ≤30%. Recent observational studies suggest, however, that these tests may have greater utility in patients with LVEF >30%. Because SCD results from multiple mechanisms, it is likely that combinations of risk factors will prove more precise for risk stratification. Prospective trials that evaluate the performance of risk stratification schema to determine ICD use are necessary for cost-effective reduction of the incidence of SCD after MI.

Association between the Charlson comorbidity index and outcomes after implantable cardioverter defibrillator generator replacement.

BACKGROUND: Recipients of implantable cardioverter defibrillator (ICD) generator replacement with multiple medical comorbidities may be at higher risk of adverse outcomes that attenuate the benefit of ICD replacement. The aim of this investigation was to study the association between the Charlson comorbidity index (CCI) and outcomes after ICD generator replacement. METHODS: All patients undergoing first ICD generator replacement at Mayo Clinic, Rochester and Beth Israel Deaconess Medical Center, Boston between 2001 and 2011 were identified. Outcomes included: (a) all-cause mortality, (b) appropriate ICD therapy, and (c) death prior to appropriate therapy. Multivariable Cox regression analysis was performed to assess association between CCI and outcomes. RESULTS: We identified 1421 patients with mean age of 69.6 ± 12.1 years, 81% male and median (range) CCI of 3 (0-18). During a mean follow-up of 3.9 ± 3 years, 52% of patients died, 30.6% experienced an appropriate therapy, and 23.6% died without experiencing an appropriate therapy. In multivariable analysis, higher CCI score was associated with increased all-cause mortality (Hazard ratio, HR 1.10 [1.06-1.13] per 1 point increase in CCI, P < .001), death without prior appropriate therapy (HR 1.11 [1.07-1.15], P < .0001), but not associated with appropriate therapy (HR 1.01 [0.97-1.05], P = .53). Patients with CCI ≥5 had an annual risk of death of 12.2% compared to 8.7% annual rate of appropriate therapy. CONCLUSIONS: CCI is predictive of mortality following ICD generator replacement. The benefit of ICD replacement in patients with CCI score ≥5 should be investigated in prospective studies.

High-power and short-duration ablation for pulmonary vein isolation: Safety, efficacy, and long-term durability.

INTRODUCTION: PV reconnection is often the result of catheter instability and tissue edema. High-power short-duration (HP-SD) ablation strategies have been shown to improve atrial linear continuity in acute pre-clinical models. This study compares the safety, efficacy, and long-term durability of HP-SD ablation with conventional ablation. METHODS AND RESULTS: In 6 swine, 2 ablation lines were performed anterior and posterior to the crista terminalis, in the smooth and trabeculated right atrium, respectively; and the right superior PV was isolated. In 3 swine, ablation was performed using conventional parameters (Thermocool-Smarttouch® SF; 30 W/30 seconds) and in 3 other swine using HP-SD parameters (QDOT-MICRO™, 90 W/4 seconds). After 30 days, linear integrity was examined by voltage mapping and pacing, and the heart and surrounding tissues were examined by histopathology. Acute line integrity was achieved with both ablation strategies; however, HP-SD ablation required 80% less RF time compared with conventional ablation (P ≤ 0.01 for all lines). Chronic line integrity was higher with HP-SD ablation: all 3 posterior lines were continuous and transmural compared to only 1 line created by conventional ablation. In the trabeculated tissue, HP-SD ablation lesions were wider and of similar depth with 1 of 3 lines being continuous compared to 0 of 3 using conventional ablation. Chronic PVI without stenosis was evident in both groups. There were no steam-pops. Pleural markings were present in both strategies, but parenchymal lung injury was only evident with conventional ablation. CONCLUSIONS: HP-SD ablation strategy results in improved linear continuity, shorter ablation time, and a safety profile comparable to conventional ablation.

High-Resolution Mapping of Postinfarction Reentrant Ventricular Tachycardia: Electrophysiological Characterization of the Circuit.

BACKGROUND: In vivo description of ventricular tachycardia (VT) circuits is limited by insufficient spatiotemporal resolution. We used a novel high-resolution mapping technology to characterize the electrophysiological properties of the postinfarction reentrant VT circuit. METHODS: In 15 swine, myocardial infarction was induced by left anterior descending artery balloon occlusion. Animals were studied 6 to 8 weeks after myocardial infarction. Activation mapping of VTs was performed by using the Rhythmia mapping system. Activation time was based on a combination of bipolar and unipolar electrograms. The response to overdrive pacing from different zones of the circuit was examined. RESULTS: A total of 56 monomorphic VTs were induced (3.8±2.1 per animal). Among these, 21 (37.5%) were hemodynamically stable and allowed mapping of the circuit. Isthmuses were 16.4±7.2 mm long and 7.4±2.8 mm wide. Conduction velocities were slowest at the inward curvature into the isthmus entrance (0.28±0.2 m/s), slightly faster at the outward curvature exit (0.40±0.3 m/s) and nearly normal at the central isthmus (0.62±0.2 m/s). In 3 animals, 2 VT morphologies with opposite axes sharing the same isthmus were mapped. Conduction velocities within the shared isthmus were dependent on the activation vector, consistently slower at the proximal curvature. Overdrive pacing from isthmus sites determined by activation mapping was consistent with entrainment criteria for isthmus. However, dimensions of the isthmus defined by entrainment exceeded dimensions of the isthmus measured by activation mapping by 32±18%. CONCLUSIONS: In postinfarction reentrant VT, conduction velocities are slowest at the proximal and distal curvatures. Entrainment mapping overestimates the true size of the isthmus. High-resolution activation mapping of VT may better guide ablation therapy.

Global Electric Heterogeneity Risk Score for Prediction of Sudden Cardiac Death in the General Population: The Atherosclerosis Risk in Communities (ARIC) and Cardiovascular Health (CHS) Studies.

BACKGROUND: Asymptomatic individuals account for the majority of sudden cardiac deaths (SCDs). Development of effective, low-cost, and noninvasive SCD risk stratification tools is necessary. METHODS AND RESULTS: Participants from the Atherosclerosis Risk in Communities study and Cardiovascular Health Study (n=20 177; age, 59.3±10.1 years; age range, 44-100 years; 56% female; 77% white) were followed up for 14.0 years (median). Five ECG markers of global electric heterogeneity (GEH; sum absolute QRST integral, spatial QRST angle, spatial ventricular gradient [SVG] magnitude, SVG elevation, and SVG azimuth) were measured on standard 12-lead ECGs. Cox proportional hazards and competing risks models evaluated associations between GEH electrocardiographic parameters and SCD. An SCD competing risks score was derived from demographics, comorbidities, and GEH parameters. SCD incidence was 1.86 per 1000 person-years. After multivariable adjustment, baseline GEH parameters and large increases in GEH parameters over time were independently associated with SCD. Final SCD risk scores included age, sex, race, diabetes mellitus, hypertension, coronary heart disease, stroke, and GEH parameters as continuous variables. When GEH parameters were added to clinical/demographic factors, the C statistic increased from 0.777 to 0.790 (P=0.008), the risk score classified 10-year SCD risk as high (>5%) in 7.2% of participants, 10% of SCD victims were appropriately reclassified into a high-risk category, and only 1.4% of SCD victims were inappropriately reclassified from high to intermediate risk. The net reclassification index was 18.3%. CONCLUSIONS: Abnormal electrophysiological substrate quantified by GEH parameters is independently associated with SCD in the general population. The addition of GEH parameters to clinical characteristics improves SCD risk prediction.

Catheter Ablation of Atypical Atrioventricular Nodal Reentrant Tachycardia.

BACKGROUND: Because of its low prevalence, data on atypical atrioventricular nodal reentrant tachycardia (AVNRT) are scarce, and the optimal ablation method has not been established. Our study aimed at assessing the efficacy and safety of conventional slow pathway ablation, as applied for typical cases, in atypical AVNRT. METHODS: We studied 2079 patients with AVNRT subjected to slow pathway ablation. In 113 patients, mean age 48.5±18.1 years, 68 female, atypical AVNRT or coexistent atypical and typical AVNRT without other concomitant arrhythmia was diagnosed. Ablation data and outcomes were compared with a group of age- and sex-matched control patients with typical AVNRT. RESULTS: Fluoroscopy and radiofrequency current delivery times were not different in the atypical and typical groups, 20.3±12.2 versus 20.8±12.9 minutes (P=0.730) and 5.9±5.0 versus 5.5±4.5 minutes (P=0.650), respectively. Slow pathway ablation was accomplished from the right septum in 110 patients, and from the left septum in 3 patients, in the atypical group. There was no need for additional ablation lesions at other anatomic sites, and no cases of atrioventricular block were encountered. Recurrence rates of the arrhythmia were 5.6% in the atypical (6/108 patients) and 1.8% in the typical (2/111 patients) groups in the next 3 months following ablation (P=0.167). CONCLUSIONS: Conventional ablation at the anatomic area of the slow pathway is the therapy of choice for symptomatic AVNRT, regardless of whether the typical or atypical form is present.

New York Heart Association class and the survival benefit from primary prevention implantable cardioverter defibrillators: A pooled analysis of 4 randomized controlled trials.

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.

Predicting appropriate shocks in patients with heart failure: Patient level meta-analysis from SCD-HeFT and MADIT II.

BACKGROUND: No precise tools exist to predict appropriate shocks in patients with a primary prevention ICD. We sought to identify characteristics predictive of appropriate shocks in patients with a primary prevention implantable cardioverter defibrillator (ICD). METHODS: Using patient-level data from the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), we identified patients with any appropriate shock. Clinical and demographic variables were included in a logistic regression model to predict appropriate shocks. RESULTS: There were 1,463 patients randomized to an ICD, and 285 (19%) had ≥1 appropriate shock over a median follow-up of 2.59 years. Compared with patients without appropriate ICD shocks, patients who received any appropriate shock tended to have more severe heart failure. In a multiple logistic regression model, predictors of appropriate shocks included NYHA class (NYHA II vs. I: OR 1.65, 95% CI 1.07-2.55; NYHA III vs. I: OR 1.74, 95% CI 1.10-2.76), lower LVEF (per 1% change) (OR 1.04, 95% CI 1.02-1.06), absence of beta-blocker therapy (OR 1.61, 95% CI 1.23-2.12), and single chamber ICD (OR 1.67, 95% CI 1.13-2.45). CONCLUSION: In this meta-analysis of patient level data from MADIT-II and SCD-HeFT, higher NYHA class, lower LVEF, no beta-blocker therapy, and single chamber ICD (vs. dual chamber) were significant predictors of appropriate shocks.

Incidence and risk factors for symptomatic heart failure after catheter ablation of atrial fibrillation and atrial flutter.

AIMS: To determine the incidence and risk factors for development of symptomatic heart failure (HF) following catheter ablation for atrial fibrillation (AF) and atrial flutter. METHODS AND RESULTS: We prospectively enrolled consecutive patients undergoing pulmonary vein isolation (PVI) or cavotricuspid isthmus (CTI) ablation between November 2013 and June 2014. Post-discharge symptoms were assessed via telephone follow-up and clinic visits. The primary outcome was symptomatic HF requiring treatment with new/increased diuretic dosing. Secondary outcomes were prolonged index hospitalization and readmission for HF ≤30 days. Univariate and multivariable logistic regressions were used to assess the relationship between patient/procedural characteristic and post-ablation HF. Among 111 PVI patients [median age 62.0 years; left ventricular ejection fraction (LVEF) 55%], 29 patients (26.1%) developed symptomatic HF, 6 patients (5.4%) required prolonged index hospitalization, and 8 patients (7.2%) were readmitted for HF. In univariate analyses, persistent AF [odds ratio (OR) 2.97, P = 0.02], AF at start of the procedure (OR 2.99, P = 0.01), additional ablation lines (OR 11.07, P < 0.0001), and final left atrial pressure (OR 1.10 per 1 mmHg increase, P = 0.02) were associated with HF development. Peri-procedural diuresis, net fluid balance, and LVEF were not correlated. In multivariable analyses, only additional ablation lines (ORadj 9.17, P = 0.007) were independently associated with post-ablation HF. Six patients (16.7%) developed HF after CTI ablation. CONCLUSION: A 26.1% of patients undergoing PVI and 16.7% of patients undergoing CTI ablation developed symptomatic HF when prospectively and uniformly assessed. 12.6% of patients experienced prolonged index hospitalizations or readmission for management of HF within 1 week after PVI. Improved understanding of risk factors for post-ablation HF may be critical in developing strategies to address during AF ablation.

Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients (PAM-ICD): Rationale and Design of an RCT Currently Underway.

BACKGROUND: Improving mental and physical health of patients with implantable cardioverter defibrillators (ICD) is critical because this group is at high risk for ventricular arrhythmias and sudden death and depressed or anxious cardiovascular disease (CVD) patients appear to be at even higher risk for mortality compared to nondepressed or nonanxious CVD patients. Further, autonomic dysfunction is present in these patients, and negative emotions and arrhythmias form a downward spiral further worsening mood, well-being, and cardiovascular health. Much research demonstrates that positive emotion is related to health benefits, improved physiology, and increased survival. METHODS AND RESULTS: This is a two-arm randomized controlled trial aiming to recruit 60 adult ICD patients comparing 12 individually delivered, weekly sessions of: (1) a positive emotion-focused cognitive-behavioral therapy (Quality of Life Therapy [QOLT]), and (2) Heart Healthy Education. Autonomic functioning, heart rhythm indices, and psychosocial health are measured at baseline, 3 months, and 9 months. The first goal is feasibility and acceptability, with the primary outcome being arrhythmic event frequency data. CONCLUSION: This study is designed to test whether QOLT produces changes in mood, quality of life/well-being, autonomic function, and arrhythmic and ICD therapy event rates. This feasibility trial is a foundational step for the next trial of QOLT to help determine whether a 3-month QOLT trial can reduce arrhythmias occurrences among ICD patients, and examine a mechanism of autonomic functioning. This study may help to develop and implement new medical or psychological therapies for ICD patients.

Risk stratification for sudden cardiac death in North America - current perspectives.

Sudden cardiac death (SCD) accounts for approximately 360,000 deaths annually in the United States, and is the cause of half of all cardiovascular deaths. In patients with severely depressed left ventricular ejection fraction (LVEF), implantable cardioverter-defibrillators (ICDs) have been shown to significantly reduce total mortality, but many factors beyond LVEF influence the relative benefit afforded by ICD implantation. In fact, among patients with prior myocardial infarction, approximately half of all SCDs occur in patients without severe LV dysfunction, and in analyses of large ICD trials, certain patient subgroups derive no benefit to ICD implantation despite having low LVEF, often due to competing non-arrhythmic mortality. Improved risk stratification tools to help select patients who are likely to derive the most benefit from ICD implantation are therefore needed. This manuscript will review studies evaluating use of ICDs in patients with mild LV systolic dysfunction and LVEF >35%, currently available ICD risk stratification models, and the rationale for designing a cohort study to prospectively validate use of an ICD risk stratification score.

Identification of subpopulations with distinct treatment benefit rate using the Bayesian tree.

Characterization of a subpopulation by the difference in marginal means of the outcome under the intervention and control may not be sufficient to provide informative guidance for individual decision and public policy making. Specifically, often we are interested in the treatment benefit rate (TBR), that is, the probability of benefitting an intervention in a meaningful way. For binary outcomes, TBR is the proportion that has "unfavorable" outcome under the control and "favorable" outcome under the intervention. Identification of subpopulations with distinct TBR by baseline characteristics will have significant implications in clinical setting where a medical intervention with potential negative health impact is under consideration for a given patient. In addition, these subpopulations with unique TBR set the basis for guidance in implementing the intervention toward a more personalized scheme of treatment. In this article, we propose a Bayesian tree based latent variable model to seek subpopulations with distinct TBR. Our method offers a nonparametric Bayesian framework that accounts for the uncertainty in estimating potential outcomes and allows more exhaustive search of the partitions of the baseline covariates space. The method is evaluated through a simulation study and applied to a randomized clinical trial of implantable cardioverter defibrillators to reduce mortality.

Influence of renal function on mortality and ventricular arrhythmias in patients undergoing first implantable cardioverter-defibrillator generator replacement.

BACKGROUND: Impaired renal function is associated with increased mortality among patients with implantable cardioverter-defibrillators (ICDs). The relationship between renal function at time of ICD generator replacement and subsequent appropriate ICD therapies is not known. METHODS AND RESULTS: We identified 441 patients who underwent first ICD generator replacement between 2000 and 2011 and had serum creatinine measured within 30 days of their procedure. Patients were divided into tertiles based on estimated glomerular filtration rate (eGFR). Adjusted Cox proportional hazard and competing risk models were used to assess relationships between eGFR and subsequent mortality and appropriate ICD therapy. Median eGFR was 37.6, 59.3, and 84.8 mL/min/1.73 m(2) for tertiles 1-3, respectively. Five-year Kaplan-Meier survival probability was 34.8%, 61.4%, and 84.5% for tertiles 1-3, respectively (P < 0.001). After multivariable adjustment, compared to tertile 3, worse eGFR tertile was associated with increased mortality (HR 2.84, 95% CI [1.36-5.94] for tertile 2; HR 3.84, 95% CI [1.81-8.12] for tertile 1). At 5 years, 57.0%, 58.1%, and 60.2% of patients remained free of appropriate ICD therapy in tertiles 1-3, respectively (P = 0.82). After adjustment, eGFR tertile was not associated with future appropriate ICD therapy. Results were unchanged in an adjusted competing risk model accounting for death. CONCLUSIONS: At time of first ICD generator replacement, lower eGFR is associated with higher mortality, but not with appropriate ICD therapies. The poorer survival of ICD patients with reduced eGFR does not appear to be influenced by arrhythmia status, and there is no clear proarrhythmic effect of renal dysfunction, even after accounting for the competing risk of death.

Comparison between single- and multi-sensor oesophageal temperature probes during atrial fibrillation ablation: thermodynamic characteristics.

AIMS: Oesophageal temperature monitoring with single-sensor probe (SSP) has a variable ability to predict oesophageal ulceration as a consequence of pulmonary vein isolation (PVI). Multi-sensor self-expandable probes (MSPs) may offer improved thermal monitoring. The objective of this study was to compare the thermodynamic characteristics of both probes during PVI. METHODS AND RESULTS: This prospective study enrolled 20 patients undergoing index PVI. Ten patients (group A) underwent dual monitoring with SSP and MSP and 10 control patients (group B) were monitored with SSP alone. Time to initial rise (>0.2°C), time to 1.0°C rise, peak temperature, and decay were recorded with each posterior wall lesion (20 W, 198 applications). The operator was blinded to the MSP temperature data and ablation was only interrupted when SSP temperature increased by ≥2°C. All patients underwent endoscopy within 24 h. Initial temperature increase was detected earlier with MSP (13.4 ± 7.5 vs. 30.5 ± 15.4 s; P < 0.001); led to shorter time to 1.0°C rise (18.5 ± 10.1 vs. 32.1 ± 12.0 s; P < 0.001); and higher change in peak temperature (1.6 ± 2.0 vs. 0.60 ± 0.53°C; P < 0.001). Decay time was similar between the probes (146.1 ± 35.3 vs. 150.4 ± 48.4 s; P = 0.89). The incidence of oesophageal ulceration was similar between the Groups A and B (5 and 4, respectively). Multi-sensor self-expandable probe provided greater sensitivity (100 vs. 60%) and similar specificity (60%) for detection of oesophageal ulceration. Five swine underwent oesophageal mapping before and after MSP placement without alteration in size or position. CONCLUSION: Multi-sensor probes provide a superior thermodynamic profile. Its clinical value in reducing oesophageal injury requires further evaluation.