Durable left ventricular assist device therapy in advanced heart failure: Patient selection and clinical outcomes.

The increasing adoption of left ventricular assist devices (LVADs) into clinical practice is related to a combination of engineering advances in pump technology and improvements in understanding the appropriate clinical use of these devices in the management of patients with advanced heart failure. This review intends to assist the clinician in identifying candidates for LVAD implantation, to examine long-term outcomes and provide an overview of the common complications related to use of these devices.

Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol.

The HeartMate 3 left ventricular assist system (LVAS; St. Jude Medical, Inc., formerly Thoratec Corporation, Pleasanton, CA) was recently introduced into clinical trials for durable circulatory support in patients with medically refractory advanced-stage heart failure.

Risk of Cardiovascular Hospitalizations from Exposure to Coarse Particulate Matter (PM10) Below the European Union Safety Threshold.

The association between exposure to air pollution and acute cardiovascular (CV) events is well documented; however, limited data are available evaluating the public health safety of various "doses" of particular matter (PM) below currently accepted safety thresholds. We explored the cross-sectional association between PM with aerodynamic diameter <10 μm (PM10) and daily CV hospitalizations in Brescia, Italy, using Poisson regression models adjusted for age, gender, and meteorologic indices. Average daily exposure to PM10 obtained from arithmetic means of air pollution data were captured by 4 selected monitoring stations.

Statin use, intensity, and 3-year clinical outcomes among older patients with coronary artery disease.

Background: Clinical trial evidence suggests that statin therapy reduces adverse clinical events and provides even greater benefit at high-intensity doses in coronary artery disease (CAD) patients, yet few studies have examined this in clinical practice.

Methods: We linked detailed in-hospital data (2005-2009) on 15,729 Get With The Guidelines-CAD patients ≥65 years prescribed statins to Centers for Medicare and Medicaid Services claims. High-intensity statin therapy was defined as discharge prescription of atorvastatin ≥40 mg, rosuvastatin ≥20 mg, or simvastatin 80 mg.

Variable Contribution of Heart Failure to Quality of Life in Ambulatory Heart Failure With Reduced, Better, or Preserved Ejection Fraction.

Objectives: The relative contribution of heart failure (HF) compared with other medical and nonmedical factors on diminished quality of life (QOL) across subtypes with reduced, better, and preserved left ventricular ejection fraction (LVEF) in a large ambulatory HF population was evaluated.

Background: Dominant factors influencing limited QOL in patients with HF have not been investigated.

Methods: Before routine HF clinic visits, 726 patients with ambulatory HF (mean age 56 ± 15 years, 37% women) completed a 1-page questionnaire that assessed QOL and relative contributions of HF compared with other medical and nonmedical factors to their QOL limitations.

Serum Osmolality and Postdischarge Outcomes After Hospitalization for Heart Failure.

Serum osmolality may fluctuate with neurohormonal activation and in response to certain therapeutics in patients with heart failure (HF). The clinical relevance of osmolality in patients with HF has not been defined. In this post hoc analysis of the Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan trial, we analyzed serum osmolality measured at discharge in 3,744 patients hospitalized for HF and reduced ejection fraction (EF ≤40%).

Femoropopliteal Artery Stent Thrombosis: Report From the Excellence in Peripheral Artery Disease Registry.

Background: There are limited data on femoropopliteal artery stent thrombosis (ST), which is a serious adverse outcome of peripheral artery interventions.

Methods And Results: Index procedures resulting in femoropopliteal ST were compared with stent procedures without subsequent ST in the Excellence in Peripheral Artery Disease registry. The study data had a total of 724 cases of stent procedures and 604 unique patients.

Pulse Pressure and Risk for Cardiovascular Events in Patients With Atherothrombosis: From the REACH Registry.

Background: Pulse pressure (PP) provides valuable prognostic information in specific populations, but few studies have assessed its value on cardiovascular outcomes in a broad, worldwide population.

Objectives: The aim of this study was to determine whether PP is associated with major adverse cardiovascular outcomes, independently of mean arterial pressure.

Methods: Participants from the international REACH (Reduction of Atherothrombosis for Continued Health) registry, which evaluates subjects with clinical atherothrombotic disease or risk factors for its development, were examined.

Sudden cardiac death in heart failure with preserved ejection fraction: a target for therapy?

The incidence and mechanisms of sudden cardiac death (SCD) among patients with heart failure with reduced ejection fraction have been well characterized. Conversely, limited data are available exploring the landscape of SCD in patients with heart failure with preserved ejection fraction (HFpEF). HFpEF is a heterogeneous clinical syndrome of increasing prevalence and is associated with substantial morbidity and mortality.

Association of Arterial Pulse Pressure With Long-Term Clinical Outcomes in Patients With Heart Failure.

Objectives: This study assessed the association between pulse pressure (PP) and adverse outcomes at 1 year in patients hospitalized for heart failure (HF).

Background: PP has been shown to be predictive of the development of HF. The value and utility of PP assessment in patients with prevalent HF is less clear.

Effect of Catheter-Based Renal Denervation on Morning and Nocturnal Blood Pressure: Insights From SYMPLICITY HTN-3 and SYMPLICITY HTN-Japan.

Unlabelled: High nighttime and early morning blood pressure (BP) have been associated with greater risk for cardiovascular events than high clinic or daytime BP. BP is typically highest in the rising hours, when morning activities typically begin. We examined the effect of renal denervation on morning (6:00-8:59 AM), daytime (9:00 AM-8:59 PM), and nighttime (1:00-5:59 AM) ambulatory BP.

Risks and Benefits Associated With Prestroke Antiplatelet Therapy Among Patients With Acute Ischemic Stroke Treated With Intravenous Tissue Plasminogen Activator.

Importance: Intravenous tissue plasminogen activator (tPA) is known to improve outcomes in ischemic stroke; however, many patients may have been receiving antiplatelet therapy before acute ischemic stroke and could face an increased risk for bleeding when treated with tPA.

Objective: To assess the risks and benefits associated with prestroke antiplatelet therapy among patients with ischemic stroke who receive intravenous tPA.

Design, Setting, And Participants: This observational study used data from the American Heart Association and American Stroke Association Get With the Guidelines-Stroke registry, which included 85 072 adult patients with ischemic stroke who received intravenous tPA in 1545 registry hospitals from January 1, 2009, through March 31, 2015.

Quality of Care and Ischemic Stroke Risk After Hospitalization for Transient Ischemic Attack: Findings From Get With The Guidelines-Stroke.

Background: Patients with transient ischemic attack (TIA) are at increased risk for ischemic stroke. We derived a prediction rule for 1-year ischemic stroke risk post-TIA, examining estimated risk, receipt of inpatient quality of care measures for TIA, and the presence or absence of stroke at 1 year post discharge.

Methods And Results: We linked 67 892 TIA Get With The Guidelines-Stroke patients >65 years (2003-2008) to Medicare inpatient claims to obtain longitudinal outcomes.

Left ventricular dimension decrement index early after axial flow assist device implantation: A novel risk marker for late pump thrombosis.

Background: It is increasingly recognized that pump thrombosis most likely represents the end stage of a complex interaction between the patient-pump interface. We hypothesized that early patient/pump mismatch, as manifested by suboptimal left ventricular (LV) unloading early after left ventricular assist device (LVAD) implantation, may be a harbinger of increased risk for later LVAD thrombosis.

Methods: In 64 patients (59 ± 11 years old, 78% men, 44% destination therapy) discharged alive without thrombosis or other device malfunction after first HeartMate II LVAD implantation (between January 2011 and June 2014), LV dimensions in end diastole (LVIDd) and end systole (LVIDs) were compared between pre-implant and optimal set speed pre-discharge echocardiography.

Role of biomarkers in cardiac structure phenotyping in heart failure with preserved ejection fraction: critical appraisal and practical use.

Heart failure (HF) with preserved ejection fraction (HFpEF) is a heterogeneous clinical syndrome characterized by cardiovascular, metabolic, and pro-inflammatory diseases associated with advanced age and extracardiac comorbidities. All of these conditions finally lead to impairment of myocardial structure and function. The large phenotypic heterogeneity of HFpEF from pathophysiological underpinnings presents a major hurdle to HFpEF therapy.

Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves.

Background: A finding of reduced aortic-valve leaflet motion was noted on computed tomography (CT) in a patient who had a stroke after transcatheter aortic-valve replacement (TAVR) during an ongoing clinical trial. This finding raised a concern about possible subclinical leaflet thrombosis and prompted further investigation.

Methods: We analyzed data obtained from 55 patients in a clinical trial of TAVR and from two single-center registries that included 132 patients who were undergoing either TAVR or surgical aortic-valve bioprosthesis implantation.

Cardiovascular risk in relation to body mass index and use of evidence-based preventive medications in patients with or at risk of atherothrombosis.

Aim: Explore the relation between body mass index (BMI) and cardiovascular disease, and the influence of optimal medical therapy (OMT) on this relationship.

Methods And Results: Patients from the REACH cohort, an international, prospective cohort of patients with or at high risk of atherosclerosis with documentation of potential confounders, including treatments and risk factors, were followed up to 4 years (n = 54 285). Patients were categorized according to baseline BMI (ranging from underweight to Grade III obesity).

Real world effectiveness of warfarin among ischemic stroke patients with atrial fibrillation: observational analysis from Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) study.

Objective: To examine the association between warfarin treatment and longitudinal outcomes after ischemic stroke in patients with atrial fibrillation in community practice.

Design: Observational study.

Setting: Hospitals (n = 1487) participating in the Get With The Guidelines (GWTG)-Stroke program in the United States, from 2009 to 2011.