Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial.

Importance: Only about half of patients with atrial fibrillation (AF) who are at increased risk for stroke are treated with an oral anticoagulant (OAC), despite guideline recommendations for their use. Educating patients with AF about prevention of stroke with OACs may enable them as agents of change to initiate OAC treatment. Objective: To determine whether an educational intervention directed to patients and their clinicians stimulates the use of OACs in patients with AF who are not receiving OACs. Design, Setting, and Participants: The Implementation of a Randomized Controlled Trial to Improve Treatment With Oral Anticoagulants in Patients With Atrial Fibrillation (IMPACT-AFib) trial was a prospective, multicenter, open-label, pragmatic randomized clinical trial conducted from September 25, 2017, to May 1, 2019, embedded in health plans that participate in the US Food and Drug Administration's Sentinel System. It used the distributed database comprising health plan members to identify eligible patients, their clinicians, and outcomes. IMPACT-AFib enrolled patients with AF, a CHA2DS2-VASc (cardiac failure or dysfunction, hypertension, age 65-74 [1 point] or ≥75 years [2 points], diabetes, and stroke, transient ischemic attack or thromboembolism [2 points]-vascular disease, and sex category [female]) score of 2 or more, no evidence of OAC prescription dispensing in the preceding 12 months, and no hospitalization-related bleeding event within the prior 6 months. Interventions: Randomization to a single mailing of patient and/or clinician educational materials vs control. Main Outcomes and Measures: Analysis was performed on a modified intention-to-treat basis. The primary end point was the proportion of patients with at least 1 OAC prescription dispensed or at least 4 international normalized ratio test results within 1 year of the intervention. Results: Among 47 333 patients, there were 24 909 men (52.6%), the mean (SD) age was 77.9 (9.7) years, mean (SD) CHA2DS2-VASc score was 4.5 (1.7), 22 404 patients (47.3%) had an ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation) bleeding risk score of 5 or more, and 8890 patients (18.8%) had a history of hospitalization for bleeding. There were 2328 of 23 546 patients (9.9%) in the intervention group with initiation of OAC at 1 year compared with 2330 of 23 787 patients (9.8%) in the control group (adjusted OR, 1.01 [95% CI, 0.95-1.07]; P = .79). Conclusions and Relevance: Among a large population with AF with a guideline indication for OACs for stroke prevention who were randomized to a mailed educational intervention or to usual care, there was no clinically meaningful, numerical, or statistically significant difference in rates of OAC initiation. More-intensive interventions are needed to try and address the public health issue of underuse of anticoagulation for stroke prevention among patients with AF. Trial Registration: ClinicalTrials.gov Identifier: NCT03259373.

Proton pump inhibitors may enhance the risk of citalopram- and escitalopram-associated sudden cardiac death among patients receiving hemodialysis.

PURPOSE: Polypharmacy is common in the hemodialysis population and increases the likelihood that patients will be exposed to clinically significant drug-drug interactions. Concurrent use of proton pump inhibitors (PPIs) with citalopram or escitalopram may potentiate the QT-prolonging effects of these selective serotonin reuptake inhibitors through pharmacodynamic and/or pharmacokinetic interactions. METHODS: We conducted a retrospective cohort study using data from the U.S. Renal Data System (2007-2017) and a new-user design to examine the differential risk of sudden cardiac death (SCD) associated with citalopram/escitalopram initiation vs. sertraline initiation in the presence and absence of PPI use among adults receiving hemodialysis. We studied 72 559 patients:14 983 (21%) citalopram/escitalopram initiators using a PPI; 26 503 (36%) citalopram/escitalopram initiators not using a PPI;10 779 (15%) sertraline initiators using a PPI; and 20 294 (28%) sertraline initiators not using a PPI (referent). The outcome of interest was 1-year SCD. We used inverse probability of treatment weighted survival models to estimate weighted hazard ratios (HRs) and 95% confidence intervals (CIs). RESULTS: Compared with sertraline initiators not using a PPI, citalopram/escitalopram initiators using a PPI had the numerically highest risk of SCD (HR [95% CI] = 1.31 [1.11-1.54]), followed by citalopram/escitalopram initiators not using a PPI (HR [95% CI] = 1.22 [1.06-1.41]). Sertraline initiators using a PPI had a similar risk of SCD compared with those not using a PPI (HR [95% CI] = 1.03 [0.85-1.26]). CONCLUSIONS: Existing PPI use may elevate the risk of SCD associated with citalopram or escitalopram initiation among hemodialysis patients.

Research Priorities in the Secondary Prevention of Atrial Fibrillation: A National Heart, Lung, and Blood Institute Virtual Workshop Report.

There has been sustained focus on the secondary prevention of coronary heart disease and heart failure; yet, apart from stroke prevention, the evidence base for the secondary prevention of atrial fibrillation (AF) recurrence, AF progression, and AF-related complications is modest. Although there are multiple observational studies, there are few large, robust, randomized trials providing definitive effective approaches for the secondary prevention of AF. Given the increasing incidence and prevalence of AF nationally and internationally, the AF field needs transformative research and a commitment to evidenced-based secondary prevention strategies. We report on a National Heart, Lung, and Blood Institute virtual workshop directed at identifying knowledge gaps and research opportunities in the secondary prevention of AF. Once AF has been detected, lifestyle changes and novel models of care delivery may contribute to the prevention of AF recurrence, AF progression, and AF-related complications. Although benefits seen in small subgroups, cohort studies, and selected randomized trials are impressive, the widespread effectiveness of AF secondary prevention strategies remains unknown, calling for development of scalable interventions suitable for diverse populations and for identification of subpopulations who may particularly benefit from intensive management. We identified critical research questions for 6 topics relevant to the secondary prevention of AF: (1) weight loss; (2) alcohol intake, smoking cessation, and diet; (3) cardiac rehabilitation; (4) approaches to sleep disorders; (5) integrated, team-based care; and (6) nonanticoagulant pharmacotherapy. Our goal is to stimulate innovative research that will accelerate the generation of the evidence to effectively pursue the secondary prevention of AF.

Research Priorities in Atrial Fibrillation Screening: A Report From a National Heart, Lung, and Blood Institute Virtual Workshop.

Clinically recognized atrial fibrillation (AF) is associated with higher risk of complications, including ischemic stroke, cognitive decline, heart failure, myocardial infarction, and death. It is increasingly recognized that AF frequently is undetected until complications such as stroke or heart failure occur. Hence, the public and clinicians have an intense interest in detecting AF earlier. However, the most appropriate strategies to detect undiagnosed AF (sometimes referred to as subclinical AF) and the prognostic and therapeutic implications of AF detected by screening are uncertain. Our report summarizes the National Heart, Lung, and Blood Institute's virtual workshop focused on identifying key research priorities related to AF screening. Global experts reviewed major knowledge gaps and identified critical research priorities in the following areas: (1) role of opportunistic screening; (2) AF as a risk factor, risk marker, or both; (3) relationship between AF burden detected with long-term monitoring and outcomes/treatments; (4) designs of potential randomized trials of systematic AF screening with clinically relevant outcomes; and (5) role of AF screening after ischemic stroke. Our report aims to inform and catalyze AF screening research that will advance innovative, resource-efficient, and clinically relevant studies in diverse populations to improve the diagnosis, management, and prognosis of patients with undiagnosed AF.

Implantable Cardioverter Defibrillator Utilization and Mortality Among Patients ≥65 Years of Age With a Low Ejection Fraction After Coronary Revascularization.

The purpose of this analysis was to assess implantable cardioverter-defibrillator (ICD) utilization and its association with mortality among patients ≥65 years of age after coronary revascularization. Patients in the National Cardiovascular Database Registry Chest Pain-Myocardial Infarction (MI) Registry who presented with MI from January 2, 2009 to December 31, 2016, had a left ventricular ejection fraction ≤35% and underwent in-hospital revascularization (10,014 percutaneous coronary intervention (PCI) and 1,647 coronary artery bypass grafting (CABG)) were linked with Medicare claims to determine rates of 1-year ICD implantation. The association between ICD implantation and 2-year mortality was assessed. Of 11,661 included patients, an ICD was implanted in 1,234 (10.6%) within 1 year of revascularization (1,063 (10.6%) PCI and 171 (10.4%) CABG). Among PCI-treated patients, in-hospital ventricular arrhythmia (adjusted hazard ratio [aHR] 1.60, 95% confidence interval [CI] 1.34 to 1.92), 2-week cardiology follow-up (aHR 1.48, 95% CI 1.29 to 1.70), readmission for heart failure (aHR 3.21, 95% CI 2.73 to 3.79), and readmission for MI (aHR 2.18, 95% CI 1.66 to 2.85) were positively associated with ICD implantation. Among CABG-treated patients, in-hospital ventricular arrhythmia (aHR 2.33, 95% CI 1.39 to 3.91), and heart failure readmission (aHR 3.14, 95% CI 1.96 to 5.04) were positively associated with ICD implantation. Women were less likely to receive an ICD, regardless of the revascularization strategy. ICD implantation was associated with lower 2-year all-cause mortality (aHR 0.74, 95% CI 0.63 to 0.86). In conclusion, only 1 in 10 Medicare patients with low ejection fraction received an ICD within 1 year after revascularization. Contact with the healthcare system after discharge was associated with higher likelihood of ICD implantation. ICD implantation was associated with lower mortality following revascularization for MI.

The subcutaneous implantable cardioverter-defibrillator in review.

The subcutaneous implantable cardioverter defibrillator (S-ICD) is a completely extrathoracic device that has recently been FDA approved for the prevention of sudden cardiac death in select populations. Although the transvenous implantable cardioverter defibrillator (TV-ICD) has a proven mortality benefit in multiple patient populations, there are significant risks both with implantation and years after its placement. The S-ICD may help prevent some of these complications. Currently, the S-ICD is typically implanted in patients with prior device infection or at an increased risk for an infection, younger patients with difficult venous access related to either hemodialysis or difficult cardiac anatomy, patients who live active lifestyles, and those who may outlive the TV-ICD leads. There is an absolute contraindication for S-ICD implantations for patients who need pacing either for ventricular tachycardia or bradycardia because this device cannot perform these functions. To date, there are no randomized controlled trial (RCT) data evaluating the safety and efficacy of this relatively new device. Observational studies of both the S-ICD alone and in comparison with the TV-ICD have showed promising results, including a decrease in lead-related and periprocedural complications as well as a high level of effectiveness at terminating ventricular arrhythmias. These analyses over time may have contributed to the evolution and comfortability with the S-ICD system, as physicians are more often referring for and/or implanting this device for patients with appropriate indications. Furthermore, inappropriate shock rates with the S-ICD have decreased over time especially with dual zone programming. This review summarizes the results of a multitude of observational studies with respect to patient selection for the S-ICD, complication rates, appropriate and inappropriate shock rates, and programming. This review also tackles current ongoing randomized trials. Although the results of ongoing trials will be helpful, there is still a continued need to evaluate the efficacy of the S-ICD in broader patient populations including patients with several comorbidities and older patients so that more patients can be considered for this potentially lifesaving device.

Outcomes of apixaban versus warfarin in patients with atrial fibrillation and multi-morbidity: Insights from the ARISTOTLE trial.

BACKGROUND: Patients with atrial fibrillation (AF) often have multi-morbidity, defined as ≥3 comorbid conditions. Multi-morbidity is associated with polypharmacy, adverse events, and frailty potentially altering response to anticoagulation. We sought to describe the prevalence of multi-morbidity among older patients with AF and determine the association between multi-morbidity, clinical outcomes, and the efficacy and safety of apixaban compared with warfarin. METHODS: In this post-hoc subgroup analysis of the ARISTOTLE trial, we studied enrolled patients age ≥ 55 years (n = 16,800). Patients were categorized by the number of comorbid conditions at baseline: no multi-morbidity (0-2 comorbid conditions), moderate multi-morbidity (3-5 comorbid conditions), and high multi-morbidity (≥6 comorbid conditions). Association between multi-morbidity and clinical outcomes were analyzed by treatment with a median follow-up of 1.8 (1.3-2.3) years. RESULTS: Multi-morbidity was present in 64% (n = 10,713) of patients; 51% (n = 8491) had moderate multi-morbidity, 13% (n = 2222) had high multi-morbidity, and 36% (n = 6087) had no multi-morbidity. Compared with the no multi-morbidity group, the high multi-morbidity group was older (74 vs 69 years), took twice as many medications (10 vs 5), and had higher CHA2DS2-VASc scores (4.9 vs 2.7) (all P < .001). Adjusted rates per 100 patient-years for stroke/systemic embolism, death, and major bleeding increased with multi-morbidity (Reference no multi-morbidity; moderate multi-morbidity 1.42 [1.24-1.64] and high multi-morbidity 1.92 [1.59-2.31]), with no interaction in relation to efficacy or safety of apixaban. CONCLUSIONS: Multi-morbidity is prevalent among the population with AF; efficacy and safety of apixaban is preserved in this subgroup supporting extension of trial results to the most complex AF patients.

Use of Biomarkers to Predict Specific Causes of Death in Patients With Atrial Fibrillation.

BACKGROUND: Atrial fibrillation is associated with an increased risk of death. High-sensitivity troponin T, growth differentiation factor-15, NT-proBNP (N-terminal pro-B-type natriuretic peptide), and interleukin-6 levels are predictive of cardiovascular events and total cardiovascular death in anticoagulated patients with atrial fibrillation. The prognostic utility of these biomarkers for cause-specific death is unknown. METHODS: The ARISTOTLE trial (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation) randomized 18 201 patients with atrial fibrillation to apixaban or warfarin. Biomarkers were measured at randomization in 14 798 patients (1.9 years median follow-up). Cox models were used to identify clinical variables and biomarkers independently associated with each specific cause of death. RESULTS: In total, 1272 patients died: 652 (51%) cardiovascular, 32 (3%) bleeding, and 588 (46%) noncardiovascular/nonbleeding deaths. Among cardiovascular deaths, 255 (39%) were sudden cardiac deaths, 168 (26%) heart failure deaths, and 106 (16%) stroke/systemic embolism deaths. Biomarkers were the strongest predictors of cause-specific death: a doubling of troponin T was most strongly associated with sudden death (hazard ratio [HR], 1.48; P<0.001), NT-proBNP with heart failure death (HR, 1.62; P<0.001), and growth differentiation factor-15 with bleeding death (HR, 1.72; P=0.028). Prior stroke/systemic embolism (HR, 2.58; P>0.001) followed by troponin T (HR, 1.45; P<0.0029) were the most predictive for stroke/ systemic embolism death. Adding all biomarkers to clinical variables improved discrimination for each cause-specific death. CONCLUSIONS: Biomarkers were some of the strongest predictors of cause-specific death and may improve the ability to discriminate among patients' risks for different causes of death. These data suggest a potential role of biomarkers for the identification of patients at risk for different causes of death in patients anticoagulated for atrial fibrillation. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00412984.

Causes of Death in a Contemporary Cohort of Patients With Type 2 Diabetes and Atherosclerotic Cardiovascular Disease: Insights From the TECOS Trial.

OBJECTIVE: We evaluated the specific causes of death and their associated risk factors in a contemporary cohort of patients with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD). RESEARCH DESIGN AND METHODS: We used data from the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) study (n = 14,671), a cardiovascular (CV) safety trial adding sitagliptin versus placebo to usual care in patients with type 2 diabetes and ASCVD (median follow-up 3 years). An independent committee blinded to treatment assignment adjudicated each cause of death. Cox proportional hazards models were used to identify risk factors associated with each outcome. RESULTS: A total of 1,084 deaths were adjudicated as the following: 530 CV (1.2/100 patient-years [PY], 49% of deaths), 338 non-CV (0.77/100 PY, 31% of deaths), and 216 unknown (0.49/100 PY, 20% of deaths). The most common CV death was sudden death (n = 145, 27% of CV death) followed by acute myocardial infarction (MI)/stroke (n = 113 [MI n = 48, stroke n = 65], 21% of CV death) and heart failure (HF) (n = 63, 12% of CV death). The most common non-CV death was malignancy (n = 154, 46% of non-CV death). The risk of specific CV death subcategories was lower among patients with no baseline history of HF, including sudden death (hazard ratio [HR] 0.4; P = 0.0036), MI/stroke death (HR 0.47; P = 0.049), and HF death (HR 0.29; P = 0.0057). CONCLUSIONS: In this analysis of a contemporary cohort of patients with diabetes and ASCVD, sudden death was the most common subcategory of CV death. HF prevention may represent an avenue to reduce the risk of specific CV death subcategories.

Multiple Comorbidities and Response to Cardiac Resynchronization Therapy: MADIT-CRT Long-Term Follow-Up.

BACKGROUND: Data regarding cardiac resynchronization therapy (CRT) in patients with multiple comorbidities are limited. OBJECTIVES: This study evaluated the association of multiple comorbidities with the benefits of CRT over implantable cardioverter-defibrillator (ICD) alone. METHODS: We examined 1,214 MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy) study patients with left bundle branch block (LBBB) and 0, 1, 2, or ≥3 comorbidities, including renal dysfunction, hypertension (HTN), diabetes, coronary artery disease, history of atrial arrhythmias, history of ventricular arrhythmias, current smoking, and cerebrovascular accident. In an adjusted analysis, we analyzed risk of heart failure (HF) events or death by comorbidity group in all patients and in patients with CRT with defibrillator (CRT-D) versus ICD. Then we examined percent change in left ventricular (LV) end-diastolic volume, LV end-systolic volume, LV ejection fraction, left atrial volume, and LV dyssynchrony at 1-year in CRT-D patients by comorbidity group. RESULTS: There was an inverse relationship between comorbidity burden and improvements in LV end-systolic volume, LV end-diastolic volume, left ventricular ejection fraction, left atrial volume, and LV dyssynchrony. In an adjusted model, there was an increasing risk of death or nonfatal HF events with increasing comorbidity burden regardless of treatment group (p < 0.001). During a mean follow-up of 4.65 years, there was no interaction with respect to comorbidity burden and the benefit of CRT-D versus ICD only for death or nonfatal HF events (interaction p = 0.943). In the groups with greatest comorbidity burden (2 and ≥3), the absolute risk reduction associated with CRT-D over ICD alone appeared greater than that seen for groups with less comorbidity burden (0 and 1). CONCLUSIONS: During long-term follow-up of MADIT-CRT study patients with LBBB randomized to CRT-D, there were differences in HF or death risk and in the degree of reverse remodeling among comorbidity groups. However, the burden of comorbidity does not appear to compromise the clinical benefits of CRT-D compared with ICD alone.

Sudden Cardiac Death in Patients With Ischemic Heart Failure Undergoing Coronary Artery Bypass Grafting: Results From the STICH Randomized Clinical Trial (Surgical Treatment for Ischemic Heart Failure).

BACKGROUND: The risk of sudden cardiac death (SCD) in patients with heart failure after coronary artery bypass graft surgery (CABG) has not been examined in a contemporary clinical trial of surgical revascularization. This analysis describes the incidence, timing, and clinical predictors of SCD after CABG. METHODS: Patients enrolled in the STICH trial (Surgical Treatment of Ischemic Heart Failure) who underwent CABG with or without surgical ventricular reconstruction were included. We excluded patients with prior implantable cardioverter-defibrillator and those randomized only to medical therapy. The primary outcome was SCD as adjudicated by a blinded committee. A Cox model was used to examine and identify predictors of SCD. The Fine and Gray method was used to estimate the incidence of SCD accounting for the competing risk of other deaths. RESULTS: Over a median follow-up of 46 months, 113 of 1411 patients who received CABG without (n = 934) or with (n = 477) surgical ventricular reconstruction had SCD; 311 died of other causes. The mean left ventricular ejection fraction at enrollment was 28±9%. The 5-year cumulative incidence of SCD was 8.5%. Patients who had SCD and those who did not die were younger and had fewer comorbid conditions than did those who died of causes other than SCD. In the first 30 days after CABG, SCD (n=5) accounted for 7% of all deaths. The numerically greatest monthly rate of SCD was in the 31- to 90-day time period. In a multivariable analysis including baseline demographics, risk factors, coronary anatomy, and left ventricular function, end-systolic volume index and B-type natriuretic peptide were most strongly associated with SCD. CONCLUSIONS: The monthly risk of SCD shortly after CABG among patients with a low left ventricular ejection fraction is highest between the first and third months, suggesting that risk stratification for SCD should occur early in the postoperative period, particularly in patients with increased preoperative end-systolic volume index or B-type natriuretic peptide. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT0002359.

Prescription of Guideline-Recommended Implantable Cardioverter Defibrillator and Cardiac Resynchronization Therapy Among Patients Hospitalized With Heart Failure and Varying Degrees of Renal Function.

Implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) reduce mortality in many patients with heart failure (HF), but the current use and effectiveness of ICD/CRT in patients with chronic kidney disease (CKD) are uncertain. We examined associations between kidney function and guideline-recommended prescription of ICD/CRT in the Get With The Guidelines-Heart Failure registry, a performance improvement program for hospitalized patients with HF. We compared differences in ICD and CRT prescription between the following categories of estimated glomerular filtration rate (eGFR; mL/min/1.73 m2): ≥60, 59 to 30, <30, and dialysis dependent. From 2008 through 2014, 26,286 patients were eligible for ICD or CRT, and 16,123(61%) had an eGFR <60. De novo ICD and CRT prescription in this group was low at 45% and 30.5%, respectively. Compared to patients with eGFR ≥60, patients with eGFR 30 to 59 were more likely to receive an ICD (adjusted odds ratio [aOR] 1.08, 95% confidence intervals [CI] 1.01 to 1.14), whereas dialysis patients were less likely (aOR 0.61, 95% CI 0.5 to 0.76). Worse kidney function was associated with a decreased likelihood of CRT prescription (aOR 0.97 per 10 ml/min eGFR decrease, p = 0.03). During the study period, the likelihood of both ICD and CRT prescription increased over time among patients with CKD (ICD aOR 1.12, 95% CI 1.07 to 1.18; CRT aOR 1.14, 95% CI 1.06 to 1.23, per year). Prescription of an ICT/CRT was associated with greater 1-year survival in all eGFR groups. In conclusion, there are significant CKD-based differences in prescription of ICD and CRT in HF. However, given the current state of evidence, it is unclear whether improved prescription of ICD and CRT in the CKD population will result in improvement in outcomes.

Reassessment of Cardiac Function and Implantable Cardioverter-Defibrillator Use Among Medicare Patients With Low Ejection Fraction After Myocardial Infarction.

BACKGROUND: Guidelines recommend that patients with low ejection fraction (EF) after myocardial infarction (MI) have their EF reassessed 40 days after MI for implantable cardioverter-defibrillator (ICD) candidacy. This study examines rates of EF reassessment and their association with 1-year ICD implantation in post-MI patients with low EF. METHODS: We examined rates of postdischarge EF reassessment and ICD implantation among 10 289 Medicare-insured patients ≥65 years of age with an EF≤35% during the index MI admission from January 2007 through September 2010 in ACTION Registry-GWTG (Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines). Multivariable Cox models tested the association between time-dependent EF reassessment and 1-year ICD implantation, stratified by revascularization status during the index MI admission. RESULTS: Among patients with EF ≤35% during the index MI admission, 66.8% (95% confidence interval [CI], 65.9-67.8) had EF reassessment within the next year. Revascularized patients were more likely to have EF reassessment (76.9% [95% CI, 75.8-78.0)] versus 53.7% [95% CI, 52.2-55.2]; P<0.001) and had shorter times to EF reassessment (median, 67 versus 84 days; P<0.001) than nonrevascularized patients. Among patients with EF reassessment, only 11% received an ICD within 1 year. Reassessment of EF was associated with a higher likelihood of ICD implantation for both revascularized (unadjusted, 12.1% versus 2.4%, P<0.001; adjusted hazard ratio, 10.6, 95% CI, 7.7-14.8) and nonrevascularized (unadjusted, 10.0% versus 1.7%, P<0.001; adjusted hazard ratio, 6.1, 95% CI, 4.1-9.2) patients. CONCLUSIONS: In US practice, EF reassessments are commonly performed among patients with MI with an initially reduced EF. Although 1-year EF reassessment is associated with increased likelihood of ICD implantation, 1-year ICD implantation rates remain very low even among patients with EF reassessment, regardless of revascularization status.

Outcomes 1 Year After Implantable Cardioverter-Defibrillator Lead Abandonment Versus Explantation for Unused or Malfunctioning Leads: A Report from the National Cardiovascular Data Registry.

BACKGROUND: Patients with an unused or malfunctioning implantable cardioverter-defibrillator (ICD) lead may have the lead either abandoned or explanted; yet there are limited data on the comparative acute and longer-term safety of these 2 approaches. METHODS AND RESULTS: We examined in-hospital events among 24 908 subject encounters using propensity score 1:1 matching for ICD lead abandonment or explantation in the National Cardiovascular Data Registry (NCDR) ICD Registry (April 2010 to June 2014). Relative to patients undergoing lead abandonment, patients undergoing lead explantation had more in-hospital procedure-related complications: 2.19% (n=273) versus 3.77% (n=469; P<0.001), respectively. Similarly, patients undergoing lead explantation had slightly higher rates of in-hospital death: 0.21% (n=26) versus 0.64% (n=80; P<0.001), respectively. At 1 year in a Medicare subset for survival, there was a trend of increased mortality in the explantation group (11% versus 8%; P=0.06). In the Medicare subset analyzed for postprocedure complications, there was no difference with respect to 6-month bleeding (4.80% in both the groups), tamponade (0.38% versus 0.58%), infection (1.34% versus 3.07%), upper extremity thrombosis (0.77% versus 0.96%), pulmonary embolism (0.38% versus 0.96%), or urgent surgery (1.15% for both the groups; P>0.05 for all). CONCLUSIONS: After matching, patients undergoing removal of an unused or malfunctioning ICD lead had slightly higher in-hospital complications and deaths than those with a lead abandonment strategy. Although the 1-year mortality risk was slightly higher in the lead explantation group, this difference was not statistically significant and may be explained by chance.

Surgery for Aortic Dilatation in Patients With Bicuspid Aortic Valves: A Statement of Clarification From the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

Two guidelines from the American College of Cardiology (ACC), the American Heart Association (AHA), and collaborating societies address the risk of aortic dissection in patients with bicuspid aortic valves and severe aortic enlargement: the "2010 ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease" (Circulation. 2010;121:e266-e369) and the "2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease" (Circulation. 2014;129:e521-e643). However, the 2 guidelines differ with regard to the recommended threshold of aortic root or ascending aortic dilatation that would justify surgical intervention in patients with bicuspid aortic valves. The ACC and AHA therefore convened a subcommittee representing members of the 2 guideline writing committees to review the evidence, reach consensus, and draft a statement of clarification for both guidelines. This statement of clarification uses the ACC/AHA revised structure for delineating the Class of Recommendation and Level of Evidence to provide recommendations that replace those contained in Section 9.2.2.1 of the thoracic aortic disease guideline and Section 5.1.3 of the valvular heart disease guideline.

Risk Stratification for Arrhythmic Events in Patients With Asymptomatic Pre-Excitation: A Systematic Review for the 2015 ACC/AHA/HRS Guideline for the Management of Adult Patients With Supraventricular Tachycardia: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society.

OBJECTIVE: To review the literature systematically to determine whether noninvasive or invasive risk stratification, such as with an electrophysiological study of patients with asymptomatic pre-excitation, reduces the risk of arrhythmic events and improves patient outcomes. METHODS: PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (all January 1, 1970, through August 31, 2014) were searched for randomized controlled trials and cohort studies examining noninvasive or invasive risk stratification in patients with asymptomatic pre-excitation. Studies were rejected for low-quality design or the lack of an outcome, population, intervention, or comparator of interest or if they were written in a language other than English. RESULTS: Of 778 citations found, 9 studies met all the eligibility criteria and were included in this paper. Of the 9 studies, 1 had a dual design-a randomized controlled trial of ablation versus no ablation in 76 patients and an uncontrolled prospective cohort of 148 additional patients-and 8 were uncontrolled prospective cohort studies (n=1594). In studies reporting a mean age, the range was 32 to 50 years, and in studies reporting a median age, the range was 19 to 36 years. The majority of patients were male (range, 50% to 74%), and <10% had structural heart disease. In the randomized controlled trial component of the dual-design study, the 5-year Kaplan-Meier estimates of the incidence of arrhythmic events were 7% among patients who underwent ablation and 77% among patients who did not undergo ablation (relative risk reduction: 0.08; 95% confidence interval: 0.02 to 0.33; P<0.001). In the observational cohorts of asymptomatic patients who did not undergo catheter ablation (n=883, with follow-up ranging from 8 to 96 months), regular supraventricular tachycardia or benign atrial fibrillation (shortest RR interval >250 ms) developed in 0% to 16%, malignant atrial fibrillation (shortest RR interval ≤250 ms) in 0% to 9%, and ventricular fibrillation in 0% to 2%, most of whom were children in the last case. CONCLUSIONS: The existing evidence suggests risk stratification with an electrophysiological study of patients with asymptomatic pre-excitation may be beneficial, along with consideration of accessory-pathway ablation in those deemed to be at high risk of future arrhythmias. Given the limitations of the existing data, well-designed and well-conducted studies are needed.