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International audience; Abstract BackgroundThe UNTOUCHED study will assess the safety and efficacy of the subcutaneous implantable cardioverter defibrillator (S‐ICD) in the most common cohort of patients receiving ICDs. The primary goal is to evaluate the inappropriate shock (IAS)‐free rate in primary prevention patients with a reduced ejection fraction (EF) and compare with a historical control of transvenous ICD patients with similar programming. Methods and ResultsThe UNTOUCHED study is a global, multicenter, prospective, nonrandomized study of patients undergoing de novo S‐ICD implantation for primary prevention of sudden cardiac death with a left ventricular EF ≤35%. The primary end point of this trial is freedom from IAS at 18 months. The lower 95% confidence bound of the observed incidence will be compared to a performance goal of 91.6%, which was derived from the IAS rate in MADIT‐RIT. The secondary end points are all‐cause shock‐free rate at 18 months, and system‐ and procedure‐related complication‐free rate at 1 month and 6 months. Enrollment of a minimum of 1,100 subjects from up to 200 centers worldwide is planned based on power calculations of the primary and principal secondary end points. ConclusionsThis trial will provide important data regarding the rates of inappropriate and appropriate shock therapy in real‐world use of the S‐ICD in the most common group of patients receiving ICDs.

Background Clinical outcomes of cardiac resynchronization therapy (CRT) in patients over the age of 80 have not been well described. Methods We retrospectively identified 96 consecutive patients ≥ 80 years old who underwent an initial implant or an upgrade to CRT, with or without defibrillator (CRT-D vs. CRT-P), at our institution between January 2003 and July 2008. The control cohort consisted of 177 randomly selected patients < 80 years old undergoing CRT implant during the same time period. The primary efficacy endpoint was all-cause mortality at 36 months, assessed by Kaplan-Meier time to first event curves. Results In the octogenarian cohort, mean age at CRT implant was 83.1 ± 2.9 years vs. 60.1 ± 8.8 years among controls (P < 0.001). Across both groups, 70% were male, mean left ventricular ejection fraction (LVEF) was 24.8% ± 14.1% and QRS duration was 154 ± 24.8 ms, without significant differences between groups. Octogenarians were more likely to have ischemic cardiomyopathy (74% vs. 37%, P < 0.001) and more likely to undergo upgrade to CRT instead of an initial implant (42% vs. 19%, P < 0.001). The rate of appropriate defibrillator shocks was lower among octogenarians (14% vs. 27%, P = 0.02) whereas the rate of inappropriate shocks was similar (3% vs. 6%, P = 0.55). At 36 months, there was no significant difference in the rate of all-cause mortality between octogenarians (11%) and controls (8%, P = 0.381). Conclusion Appropriately selected octogenarians who are candidates for CRT have similar intermediate-term mortality compared to younger patients receiving CRT.

Background: Pulmonary vein (PV) reverse remodeling has been recognized following atrial fibrillation (AF) ablation. However, the extent of physiologic reverse remodeling after AF ablation and the potential impact of reverse remodeling on the radiographic diagnosis of PV stenosis have not been well characterized.

As the global burden of cardiovascular disease continues to increase worldwide, nurturing the development of early-career cardiologists interested in global health is essential to create a cadre of providers with the skill set to prevent and treat cardiovascular diseases in international settings. As such, interest in global health has increased among cardiology trainees and early-career cardiologists over the past decade. International clinical and research experiences abroad present an additional opportunity for growth and development beyond traditional cardiovascular training. We describe the American College of Cardiology International Cardiovascular Exchange Database, a new resource for cardiologists interested in pursuing short-term clinical exchange opportunities abroad, and report some of the benefits and challenges of global health cardiovascular training in both resource-limited and resource-abundant settings.

© 2015 American College of Cardiology Foundation. Cardiovascular morbidity and mortality as a result of inhaled tobacco products continues to be a global healthcare crisis, particularly in low- and middle-income nations lacking the infrastructure to develop and implement effective public health policies limiting tobacco use. Following initiation of public awareness campaigns 50 years ago in the United States, considerable success has been achieved in reducing the prevalence of cigarette smoking and exposure to secondhand smoke. However, there has been a slowing of cessation rates in the United States during recent years, possibly caused by high residual addiction or fatigue from cessation messaging. Furthermore, tobacco products have continued to evolve faster than the scientific understanding of their biological effects. This review considers selected updates on the genetics and epigenetics of smoking behavior and associated cardiovascular risk, mechanisms of atherogenesis and thrombosis, clinical effects of smoking and benefits of cessation, and potential impact of electronic cigarettes on cardiovascular health.

Background. Recent experimental and clinical data suggest that lowering serum lipid levels with statins may prevent or delay the process of restenosis. The purpose of this trial is to determine whether lipid levels relate to restenosis and/or whether statin therapy can prevent or delay the process of restenosis after intracoronary stenting. Methods: One hundred thirty-six patients who underwent single coronary artery stenting from June 1995 to June 1997 in our institution were included in the study. All these patients were followed for at least 9 months (mean 392 +/- 148 days) for major adverse cardiac events (MACE). We defined as MACE the occurrence of death, myocardial infarction, or need for target lesion revascularization. From this cohort, 103 patients had at least one lipid parameter from the lipid profile evaluated within 2 months from the date of the procedure. Patients who had the stent because of an acute myocardial infarction were included in the study only if their lipid profile was evaluated before or at least 6 weeks after the event. Patients with triglyceride levels above 500 had both triglyceride and low-density lipoprotein cholesterol levels excluded from the statistical analysis. Patients were divided into two groups based on lipid levels: normal (Group 1; n = 31) and elevated (Group II; n = 72). Patient outcomes were also analyzed by statin therapy use. Results: There was no significant difference in MACE rates between the two groups when outcomes were analyzed by lipid levels (22.6% versus 20.8% P = 0.8). Furthermore, outcomes were analyzed by use of statin therapy (Group III, n = 53, on statin versus Group IV, n = 50, on no statin). There was also no difference in MACE rates between the two groups (20.8% versus 22%; P = 0.8). Conclusion: The process of restenosis has unique features that differentiate it from atherosclerosis. Although lipid-lowering therapy is crucial in delaying the process of atherosclerosis, its role in the prevention of restenosis is yet to be proven.

The recently commercially available subcutaneous implantable cardioverter-defibrillator (S-ICD) uses a completely subcutaneous electrode configuration to treat potentially lethal ventricular tachyarrhythmia. Clinical trials have proven its effectiveness in detecting and treating ventricular fibrillation and tachycardia. The S-ICD offers the advantage of eliminating the need for intravenous and intracardiac leads and their associated risks and shortcomings. However, its major disadvantage is its inability to provide bradycardia rate support and antitachycardia pacing to terminate ventricular tachycardia. This paper discusses the S-ICD clinical trials and advantages and disadvantages of this novel technology to help the physician identify its role and select candidate patients who will benefit from this device.

ObjectivesThe purpose of this study was to identify predictors and clinical implications of permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR).BackgroundCardiac conduction disturbances requiring PPM are a frequent complication of TAVR. However, limited data is available regarding this complication after TAVR with a balloon-expandable valve.MethodsThe study included patients without prior pacemaker who underwent TAVR in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry and investigated predictors and clinical effect of new PPM.ResultsOf 2,559 TAVR patients, 586 were excluded due to pre-existing PPM. A new PPM was required in 173 of the remaining 1,973 patients (8.8%). By multivariable analysis, predictors of PPM included right bundle branch block (odds ratio [OR]: 7.03, 95% confidence interval [CI]: 4.92 to 10.06, p < 0.001), prosthesis diameter/left ventricular (LV) outflow tract diameter (for each 0.1 increment, OR: 1.29, 95% CI: 1.10 to 1.51, p = 0.002), LV end-diastolic diameter (for each 1 cm, OR: 0.68, 95% CI: 0.53 to 0.87, p = 0.003), and treatment in continued access registry (OR: 1.77, 95% CI: 1.08 to 2.92, p = 0.025). Patients requiring PPM had a longer mean duration of post-procedure hospitalization (7.3 ± 2.7 days vs. 6.2 ± 2.8 days, p = 0.001). At 1 year, new PPM was associated with significantly higher repeat hospitalization (23.9% vs. 18.2%, p = 0.05) and mortality or repeat hospitalization (42.0% vs. 32.6%, p = 0.007). There was no difference between groups in LV ejection fraction at 1 year.ConclusionsPPM was required in 8.8% of patients without prior PPM who underwent TAVR with a balloon-expandable valve in the PARTNER trial and registry. In addition to pre-existing right bundle branch block, the prosthesis to LV outflow tract diameter ratio and the LV end-diastolic diameter were identified as novel predictors of PPM after TAVR. New PPM was associated with a longer duration of hospitalization and higher rates of repeat hospitalization and mortality or repeat hospitalization at 1 year. (THE PARTNER TRIAL: Placement of AoRtic TraNscathetER Valves Trial; NCT00530894)

ObjectivesThis study sought to investigate the prevalence, predictors, and outcomes of patients with post-operative ventricular arrhythmia (POVA) in a large cohort of patients.BackgroundNew-onset POVA after cardiac surgery (CS) is uncommon and has controversial prognostic value.MethodsA total of 14,720 consecutive patients undergoing CS at Emory University between January 2004 and July 2010 were included in the study. Data on all-cause mortality were obtained from Social Security Administration death records. Multivariable regression models were constructed to determine the risk factors for POVA and to estimate the independent impact of POVA on long-term survival after adjusting for 40 different covariates.ResultsPOVA occurred in 248 patients (1.7%). Patients with POVA were older (63.5 vs. 61.6 years), had lower left ventricular ejection fraction (EF) (43.7 vs. 51.3), and had greater comorbidities (Society of Thoracic Surgeons mortality risk score of 7.2% vs. 3.1%, p < 0.001). Multivariable analysis showed that older age (odds ratio [OR]: 1.018 per 1-year increase, p < 0.001), emergent surgery (OR: 1.77, p = 0.019), and the presence of PVD (OR: 1.41, p = 0.049) were associated with a higher incidence of POVA, whereas higher left ventricular EF (OR: 0.97 per 1% increase, p < 0.001), mild chronic obstructive pulmonary disease (OR: 0.37, p < 0.001), and off-pump surgery (OR: O.41, p < 0.001) were associated with a lower incidence of POVA. POVA was associated with substantially increased adjusted long-term mortality (hazard rate: 2.53, p < 0.001) over 3.5 years of follow-up.ConclusionsPOVA is associated with increased long-term mortality after CS. Older age, PVD, lower EF, and emergent surgery are associated with a higher risk of POVA, whereas off-pump surgery seems to be protective.

Although implantable cardioverter-defibrillators (ICDs) are frequently viewed as a lifelong commitment in that patients are routinely scheduled for generator exchange (GE) at end of battery life, several considerations should prompt a reevaluation of risks and benefits before GE. Compared with initial ICD implant, patients receiving replacement devices are older, and have more comorbidities and shorter life expectancy, all of which may limit the benefit of ICD therapy following GE. Additionally, GE is associated with significant complications, including infection, which may increase the risk of mortality. In this paper, we review recent data regarding opportunities for risk stratification before GE, with a particular focus on those with improved left ventricular function and those who have not experienced ICD therapies during the first battery life. We also provide a broader perspective on ICD therapy, focusing on how decisions regarding GE may affect goals of care at the end of life.