Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States.

OBJECTIVES: The aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States. BACKGROUND: The National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of "real-world" patients have not been previously reported. METHODS: Patients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates. RESULTS: The study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA2DS2-VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier-estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure. CONCLUSIONS: This study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy.

Comparison of Incident Cardiovascular Event Rates Between Generic and Brand l-Thyroxine for the Treatment of Hypothyroidism.

OBJECTIVE: To determine whether levothyroxine (L-T4) preparation (generic vs brand) affected hospitalization for cardiovascular events. PATIENTS AND METHODS: We performed a retrospective analysis using a large administrative claims database, OptumLabs Data Warehouse, creating two 1-to-1 propensity score-matched cohorts initiating generic or brand L-T4. Patients were followed for a mean of 1.0±1.2 years (range, 0-9.3 years). We included 87,902 propensity score-matched patients (43,951 patients per cohort) initiating generic or brand L-T4. Variables included in matching were age, sex, race/ethnicity, residence region, selected comorbidities, and Charlson-Deyo comorbidity score. Patients with previous use of any thyroid preparation, amiodarone, or lithium were excluded. Primary outcomes were the event rates for hospitalizations for incident atrial fibrillation, myocardial infarction, congestive heart failure, or stroke. RESULTS: In the generic L-T4 cohort, 35,242 (80.2%) were women and 7327 (16.7%) were 65 years of age or older; in the brand L-T4 cohort, 34,633 (78.8%) were women and 8092 (18.4%) were 65 years of age or older. We found no differences in event rates (events per 1000 person-years) for 4 outcomes comparing generic and brand L-T4 therapy: (1) atrial fibrillation (1.82 vs 2.19; hazard ratio [HR], 1.22; 95% CI, 0.90-1.65; P=.19); (2) myocardial infarction (2.12 vs 1.83; HR, 0.86; 95% CI, 0.64-1.17; P=.35); (3) congestive heart failure (2.27 vs 2.00; HR, 0.88; 95% CI, 0.66-1.18; P=.41); and (4) stroke (3.10 vs 2.38; HR, 0.77; 95% CI, 0.59-1.00; P=.05). Stratification by age group revealed no differences. CONCLUSION: In patients with newly treated hypothyroidism, cardiovascular event rates were similar for generic and brand L-T4.

Arrhythmia care in Africa.

Data on cardiovascular disease, including arrhythmias, in Africa is limited. However, the burden of cardiovascular disease appears to be on the rise. Recent global data suggests an increase in atrial fibrillation rates despite declining rates of rheumatic heart disease. Atrial fibrillation is also associated with increased mortality in Africa. Current management with medical therapy is sub-optimal and ablation procedures, inaccessible. Atrial fibrillation is also an independent risk factor for death in patients with rheumatic heart disease. Sudden cardiac deaths from ventricular arrhythmias are under-recognized and inadequately treated with very high rates out of hospital cardiac arrest due to poor education of the general public on cardiopulmonary resuscitation skills and lack of essential healthcare infrastructure. Use of cardiac devices such as implantable defibrillators and pacemakers is low with significant regional variations and is almost non-existent in sub-Saharan Africa. There is a great unmet need for arrhythmia diagnosis and management in Africa. Governments and healthcare stakeholders need to include cardiovascular disease as a healthcare priority given the rising burden of disease and associated mortality.

Frequency of in-hospital adverse outcomes and cost utilization associated with cardiac resynchronization therapy defibrillator implantation in the United States.

BACKGROUND: The utilization of cardiac resynchronization therapy defibrillator (CRT-D) has increased significantly, since its initial approval for use in selected patients with heart failure. Limited data exist as for current trends in implant-related in-hospital complications and cost utilization. The aim of our study was to examine in-hospital complication rates associated with CRT-D and their trends over the last decade. METHODS AND RESULTS: Using the Nationwide Inpatient Sample, we estimated 378 248 CRT-D procedures from 2003 to 2012. We investigated common complications, including mechanical, cardiovascular, pericardial complications (hemopericardium, cardiac tamponade, or pericardiocentesis), pneumothorax, stroke, vascular complications (consisting of hemorrhage/hematoma, incidents requiring surgical repair, and accidental arterial puncture), and in-hospital deaths described with CRT-D, defining them by the validated International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code. Mechanical complications (5.9%) were the commonest, followed by cardiovascular (3.6%), respiratory failure (2.4%), and pneumothorax (1.5%). Age (≥65 years), female gender (OR, 95% CI; P value) (1.08, 1.03-1.13; 0.001), and the Charlson score ≥3 (1.52, 1.45-1.60; <0.001) were significantly associated with increased mortality/complications. CONCLUSIONS: The overall complication rate in patients undergoing CRT-D has been increasing in the last decade. Age (≥65), female sex, and the Charlson score ≥3 were associated with higher complications. In patients who underwent CRT-D implantation, postoperative complications were associated with significant increases in cost.

Mayo Registry for Telemetry Efficacy in Arrest Study: An Assessment of the Utility of Telemetry in Predicting Clinical Decompensation.

INTRODUCTION: Our study assesses the utility of telemetry in identifying decompensation in patients with documented cardiopulmonary arrest. METHODS: A retrospective review of inpatients who experienced a cardiopulmonary arrest from May 1, 2008, until June 30, 2014, was performed. Telemetry records 24 hours prior to and immediately preceding cardiopulmonary arrest were reviewed. Patient subanalyses based on clinical demographics were made as well as analyses of survival comparing patients with identifiable rhythm changes in telemetry to those without. RESULTS: Of 242 patients included in the study, 75 (31.0%) and 110 (45.5%) experienced telemetry changes at the 24-hour and immediately preceding time periods, respectively. Of the telemetry changes, the majority were classified as nonmalignant (n = 50, 66.7% and n = 66, 55.5% at 24 hours prior and immediately preceding, respectively). There was no difference in telemetry changes between intensive care unit (ICU) and non-ICU patients and among patients stratified according to the American Heart Association telemetry indications. There was no difference in survival when comparing patients with telemetry changes immediately preceding and at 24 hours prior to an event (n = 30, 27.3% and n = 15, 20.0%) to those without telemetry changes during the same periods (n = 27, 20.5% and n = 42, 25.2%; P = .22 and .39). CONCLUSION: Telemetry has limited utility in predicting clinical decompensation in the inpatient setting.

Mayo registry for telemetry efficacy in arrest (MR TEA) study: An assessment of the effect of admission diagnosis on outcomes from in-hospital cardiopulmonary arrest.

INTRODUCTION: Little data exists evaluating how different risk factors influence outcomes following in-hospital arrests. METHODS: A retrospective review of patients that suffered a cardiopulmonary arrest between 1 May 2008 and 30 June 2014 was performed. Patients were stratified into subsets based on cardiac versus non-cardiac reasons for admission. RESULTS: 199 patients met inclusion criteria, of which 138 (69.3%) had a non-cardiac reason for admission and 61 (30.7%) a cardiac etiology. No difference in demographics and non-cardiac comorbidities were present. Cardiac-related comorbidities were more prevalent in the cardiac etiology subset. Arrests with a shockable rhythm were more common in the cardiac group (P < 0.0001), yet return of spontaneous circulation from the index event was similar (P = 0.254). More patients in the cardiac group were alive at 24-h post resuscitation (n = 34, 55.7% versus n = 49, 35.5%; P = 0.0085), discharge (n = 21, 34.4% versus n = 19, 13.8%; P = 0.0018), and at last follow-up (n = 13, 21.3% versus n = 14, 10.1%; P = 0.0434). CONCLUSION: Although patients with cardiac and non-cardiac etiologies for admission have similar rates of return of spontaneous circulation, those with cardiac etiologies are more likely to survive to hospital discharge and outpatient follow-up.

Remote monitoring of patients with implanted cardiac devices.

Three different types of implantable cardiac devices are now commonly used in clinical medicine: pacemakers (including cardiac resynchronization systems), cardiac defibrillators, and loop recorders. Although pacing specialists and electrophysiologists have traditionally been responsible for device follow-up, the newest generation of implanted devices stores a wealth of information that can be useful to the clinical cardiologist. Important information, in addition to device function, such as incidence and type of arrhythmias, general clinical condition of the patient, and hemodynamic status can now be stored on large databases that are available via web access to all physicians caring for an individual patient. The advent of the remote monitoring capability of implanted devices has initiated a rapidly accelerating paradigm shift in device follow-up that can potentially improve patient care at lower cost.

Atrial fibrillation ablation leads to long-term improvement of quality of life and reduced utilization of healthcare resources.

In some patients, rapid activation from one or several foci can lead to atrial fibrillation. This study evaluated long-term changes in quality of life and healthcare resource utilization in patients with atrial fibrillation treated by ablation of focal triggers. Thirty-three patients underwent ablation for paroxysmal atrial fibrillation. Health surveys (SF-36) were obtained at baseline, and after 1 year and 3 years of follow-up. Health care costs were measured for the 3 years before and after ablation. Ablation was successful in 82%, partially successful in 12% (no sustained episodes but on antiarrhythmic drug therapy), and unsuccessful in 6% of patients. The average number of ablation procedures was 1.6 +/- 0.6 per patient. After ablation, patients reported significantly improved quality of life in all SF-36 categories except bodily pain. Healthcare resource utilization was significantly reduced after ablation (Clinic visits: 7.4 +/- 2.5 per year vs. 1.1 +/- 0.6 per year, p < 0.05; Emergency room visits: 1.7 +/- 0.90 per year vs. 0.03 +/- 0.17 per year, p < 0.05; Hospitalization: 1.6 +/- 0.81 vs. 0, p < 0.05). Cost of healthcare (not including procedural costs) was significantly reduced after ablation (Pre-ablation: 1,920 +/- 889 dollars/year vs. post-ablation: 87 +/- 68 dollars/year; p < 0.01). Procedural cost of ablation was 17,173 +/- 2,466 dollars/patient. Ablation of focal triggers of atrial fibrillation is associated with a sustained improvement in quality of life. Although the initial cost of ablation is high, after ablation, utilization of healthcare resources is significantly reduced.