Leadless pacemaker tine damage and fracture: novel complications of a novel device fixation mechanism.

Background: Leadless pacemakers represent a paradigm-changing advancement. However, they required innovative and novel device design, including the use of nitinol tines for fixation.

Objective: We aimed to understand the potential for fracture in the novel tine-based fixation mechanism.

The Data Monitoring Committee: A Collective or a Collection?

In this commentary, we urge that a Data Monitoring Committee (DMC) should operate as a collective, that is, as a unitary whole. In so doing, its recommendations should emerge through a consensus development process, not through a vote of the members. The summary notes of its closed session, that is, its minutes, should report the recommendations of the DMC and, if necessary, the justification for those recommendations; it should not attribute opinions to individual members.

Dronedarone for the treatment of atrial fibrillation with concomitant heart failure with preserved and mildly reduced ejection fraction: a post-hoc analysis of the ATHENA trial.

Aims: Limited therapeutic options are available for the management of atrial fibrillation/flutter (AF/AFL) with concomitant heart failure (HF) with preserved (HFpEF) and mildly reduced ejection fraction (HFmrEF). Dronedarone reduces the risk of cardiovascular events in patients with AF, but sparse data are available examining its role in patients with AF complicated by HFpEF and HFmrEF.

Methods And Results: ATHENA was an international, multicentre trial that randomized 4628 patients with paroxysmal or persistent AF/AFL and cardiovascular risk factors to dronedarone 400 mg twice daily versus placebo.

Endovascular therapy of axillary artery disease with drug-coated balloon angioplasty.

The occurrence of upper-extremity arterial disease is less common than that of the lower extremities. Nevertheless, exercise-induced symptoms, when present, can significantly affect functional capacity and limit quality of life. We report a case of exertional right upper-extremity pain and severe right axillary artery disease that was revascularized using an off-label drug-coated balloon technology with resolution of symptoms.

Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in high vascular risk.

Objective: ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) are widely prescribed in patients with high cardiovascular (CV) risk. However, whether both classes have equivalent effectiveness to prevent CV events remains unclear. The aim of this study was to compare the incidence of major CV events between ACEI and ARB users.

Academic Outcomes in Children With Congenital Heart Defects: A Population-Based Cohort Study.

Background: Most studies evaluating neurocognitive outcomes in children with congenital heart defects (CHD) have focused on high-risk patients or used specialized, resource-intensive testing. To determine the association of CHD with academic outcomes and compare outcomes according to the severity of CHD, we linked state educational records with a birth defects registry and birth certificates.

Methods And Results: We performed a retrospective cohort study using data from the North Carolina Birth Defects Monitoring Program, North Carolina Department of Public Instruction, and North Carolina Department of Health and Human Services vital records.

Transapical transcatheter aortic valve replacement in patients with or without prior coronary artery bypass graft operation.

Background: Transapical approach (TA) is an established access alternative to the transfemoral technique in patients undergoing transcatheter aortic valve replacement (TAVR) for treatment of symptomatic aortic valve stenosis. The impact of prior coronary artery bypass grafting (CABG) on clinical outcomes in patients undergoing TA-TAVR is not well defined.

Methods: A single center retrospective cohort analysis of 126 patients (male 41%, mean age 85.

Biomarkers in cardiovascular clinical trials: past, present, future.

Background: Cardiovascular (CV) clinical trials are instrumental in understanding treatment effects and offer insights into the natural progression of CV disease. Biomarkers are a critical component of patient selection, end point definition, and safety monitoring, and clinical trials provide a platform for the discovery and validation of new biomarkers that may augment the understanding of disease mechanisms, risk stratification, and/or clinical decision-making.

Content: We review the roles that biomarkers have played in CV clinical trials and roles that CV clinical trials have played and will continue to play in the discovery and validation of biomarkers and their implementation in clinical practice.

Clinical correlates of long-term mortality after percutaneous interventions of saphenous vein grafts.

Background: Increasing number of patients undergo percutaneous intervention of saphenous vein grafts (SVGs). However, the clinical factors associated with long-term mortality after SVG interventions are currently less known. Accordingly, the goal of present study was to evaluate clinical correlates of long-term mortality and to develop a simple bedside tool for risk stratification in patients undergoing SVG interventions.

Discovery of proteins related to coronary artery disease using industrial-scale proteomics analysis of pooled plasma.

Background: Relating a disease state to an entire population of proteins provides an opportunity to gain new insights into a disease.

Methods: Male populations of 53 patients with angiographic coronary artery disease and 53 control subjects without coronary disease from the Duke Databank for Cardiovascular Disease were established and matched for age and race as well as extremes of risk factors. Major plasma protein abnormalities were excluded.

Acute heart failure associated with high admission blood pressure--a distinct vascular disorder?

Background: Although blood pressure (BP) is elevated in patients with acute heart failure (AHF), first admission BP has not been meticulously recorded before treatment in previous studies.

Methods: During three consecutive months, all AHF admissions (335 patients) to a city hospital which provides the sole inpatient medical service for approximately 500,000 people were registered. First BP was recorded before treatment at the first patient encounter in the ambulance or the emergency room.

Enterococcal prosthetic valve infective endocarditis: report of 45 episodes from the International Collaboration on Endocarditis-merged database.

Enterococcal prosthetic valve infective endocarditis (PVE) is an incompletely understood disease. In the present study, patients with enterococcal PVE were compared to patients with enterococcal native valve endocarditis (NVE) and other types of PVE to determine differences in basic clinical characteristics and outcomes using a large multicenter, international database of patients with definite endocarditis. Forty-five of 159 (29%) cases of definite enterococcal endocarditis were PVE.

Elevated body mass index and intermediate-term clinical outcomes after acute coronary syndromes.

Purpose: Obesity is a coronary disease risk factor, but its independent effect on clinical outcomes following acute coronary syndromes has not been quantified. We evaluated the relationship between elevated body mass index (BMI) and 30-day, 90-day, and 1-year clinical outcomes postacute coronary syndromes.

Subjects And Methods: Using 15 071 patients (normal weight [BMI = 18.

Genetic association studies in cardiology.

The last decade has witnessed the emergence of the genetic association study into the mainstream clinical literature. Technological advances and the Human Genome Project have resulted in widespread interest in exploring these new variables in clinical disease. Although the concept of relating genetic variation to disease is exciting, this excitement must be tempered by the many limitations of such analyses.

Novel approaches to clinical trials: device-related infections.

The explosive growth in the use of cardiac devices and the continued large number of thoracic operations produce a significant number of costly infectious complications. These infections represent a leading cause of death and disability after device implantation or surgery. Unfortunately, few objective data are available to validate the clinical epidemiology of surgical and device-related infections, and although the number of randomized trials is increasing, too few have tested strategies for prophylaxis or treatment, particularly in the cardiac arena.