Bedside 3D ultrasound fistula maturation assessment by non-expert sonographers provides equivalent accuracy to formal duplex sonography: A prospective clinical trial.

Background: EchoSure is an automated point-of-care 3D ultrasound (3DUS) designed to be used by dialysis technicians without advanced ultrasound training. The EchoMark/EchoSure System is a two-part system comprised of a bioresorbable implant, EchoMark, and a diagnostic ultrasound imaging platform, EchoSure. EchoSure was designed to enable any healthcare personnel in a dialysis clinic setting to obtain non-invasive, direct measurements of flow and vessel parameters that are critical quantifications used in the assessment of AVF maturation and readiness for hemodialysis cannulation.

Baroreflex activation therapy in patients with heart failure and a reduced ejection fraction: Long-term outcomes.

Aims: Carotid baroreflex activation therapy (BAT) restores baroreflex sensitivity and modulates the imbalance in cardiac autonomic function in patients with heart failure with reduced ejection fraction (HFrEF). We tested the hypothesis that treatment with BAT significantly reduces cardiovascular mortality and heart failure morbidity and provides long-term safety and sustainable symptomatic improvement.

Methods And Results: BeAT-HF was a prospective, multicentre, randomized, two-arm, parallel-group, open-label, non-implanted control trial.

Mortality in randomised controlled trials using paclitaxel-coated devices for femoropopliteal interventional procedures: an updated patient-level meta-analysis.

Background: Numerous randomised clinical trials and real-world studies have supported the safety of paclitaxel-coated devices for the treatment of femoropopliteal occlusive disease. However, a 2018 summary-level meta-analysis suggested an increased mortality risk for paclitaxel-coated devices compared with uncoated control devices. This study presents an updated analysis of deaths using the most complete and current data available from pivotal trials of paclitaxel-coated versus control devices.

Intracranial Traumatic Hematoma Detection in Children Using a Portable Near-infrared Spectroscopy Device.

Introduction: We sought to validate a handheld, near-infrared spectroscopy (NIRS) device for detecting intracranial hematomas in children with head injury.

Methods: Eligible patients were those <18 years old who were admitted to the emergency department at three academic children's hospitals with head trauma and who received a clinically indicated head computed tomography (HCT). Measurements were obtained by a blinded operator in bilateral frontal, temporal, parietal, and occipital regions.

Response by Sex in Patient-Centered Outcomes With Baroreflex Activation Therapy in Systolic Heart Failure.

Objectives: The aim of this study was to assess sex differences in the efficacy and safety of baroreflex activation therapy (BAT) in the BeAT-HF (Baroreflex Activation Therapy for Heart Failure) trial.

Background: Patients were randomized 1:1 to receive guideline-directed medical therapy (GDMT) alone (control group) or BAT plus GDMT.

Methods: Pre-specified subgroup analyses including change from baseline to 6 months in 6-min walk distance (6MWD), quality of life (QoL) assessed using the Minnesota Living With Heart Failure Questionnaire (MLWHQ), New York Heart Association (NYHA) functional class, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) were conducted in men versus women.

Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction.

Background: This study demonstrated the safety and effectiveness of baroreflex activation therapy (BAT) in patients with heart failure with reduced ejection fraction (HFrEF).

Objectives: The BeAT-HF (Baroreflex Activation Therapy for Heart Failure) trial was a multicenter, prospective, randomized, controlled trial; subjects were randomized 1:1 to receive either BAT plus optimal medical management (BAT group) or optimal medical management alone (control group).

Methods: Four patient cohorts were created from 408 randomized patients with HFrEF using the following enrollment criteria: current New York Heart Association (NYHA) functional class III or functional class II (patients who had a recent history of NYHA functional class III); ejection fraction ≤35%; stable medical management for ≥4 weeks; and no Class I indication for cardiac resynchronization therapy.

Rezūm Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study.

Objective: To report 4-year outcomes of the randomized controlled trial of water vapor thermal therapy for treatment of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia.

Materials And Methods: Total 188 subjects; 135 men ≥50years old, International Prostate Symptom Score ≥ 13, maximum flow rate (Qmax) ≤15 mL/s and prostate volume 30 to 80 cc treated with Rezūm System thermal therapy were followed 4 years; subset of 53 men who requalified for crossover from control to active treatment were followed 3years.

Results: Lower urinary tract symptoms were significantly improved within ≤3 months after thermal therapy and remained consistently durable (International Prostate Symptom Score 47%, quality of life 43%, Qmax 50%, Benign Prostatic Hyperplasia Impact Index 52%) throughout 4years (P <.

Is Sexual Function Better Preserved After Water Vapor Thermal Therapy or Medical Therapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia?

Background: Men often experience deterioration of sexual function after the use of α-blockers and 5-α reductase inhibitors for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia. Thus, an alternative treatment with water vapor thermal therapy (Rezūm System, Boston Scientific, Marlborough, MA, USA) which is an efficacious minimally invasive surgical treatment that preserves sexual function was examined.

Aim: To compare sexual function over 3 years after continuous daily treatment with pharmaceutical agents in the Medical Therapy of Prostatic Symptoms (MTOPS) study vs a single thermal therapy procedure (Rezūm study) in subjects with matched criteria for LUTS severity and prostate size.

First granted example of novel FDA trial design under Expedited Access Pathway for premarket approval: BeAT-HF.

Background: The Food and Drug Administration (FDA) initiated the Expedited Access Pathway (EAP) to accelerate approval of novel therapies targeting unmet needs for life-threatening conditions. EAP allows for the possibility of initial FDA approval using intermediate end points with postapproval demonstration of improved outcomes.

Objective: Describe the EAP process using the BeAT-HF trial as a case study.

Three-Year Treatment Outcomes of Water Vapor Thermal Therapy Compared to Doxazosin, Finasteride and Combination Drug Therapy in Men with Benign Prostatic Hyperplasia: Cohort Data from the MTOPS Trial.

Purpose: We evaluated the long-term outcomes of treatment of lower urinary tract symptoms due to benign prostatic hyperplasia to compare a 1-time water vapor thermal therapy procedure with daily medical therapy in cohorts from the MTOPS (Medical Therapy of Prostatic Symptoms) study.

Materials And Methods: Results in the treatment arm of a randomized, controlled trial of thermal therapy using the Rezūm® System were compared to MTOPS subjects treated with doxazosin and/or finasteride. Evaluations were restricted to medical therapy subjects, representing 1,140 of the original 3,047 (37.

Inappropriate shocks in single-chamber and subcutaneous implantable cardioverter-defibrillators: a systematic review and meta-analysis.

Aims: Single-chamber (VR-ICD) and subcutaneous (S-ICD) implantable cardioverter-defibrillators are effective to protect patients against sudden death but expose them to higher risk of inappropriate shock (IS). We sought to quantify the annual rate and influencing factors of ISs in VR- and S-ICDs from the literature.

Methods And Results: PubMed, Embase, and Cochrane Library were searched for full text articles with IS rates.

Patterns of physical activity and survival following cardiac resynchronization therapy implantation: the ALTITUDE activity study.

Aims: Cardiac resynchronization therapy with implantable defibrillator backup (CRT-D) improves outcomes, but predictors and markers of response remain limited. Physical activity information collected by CRT devices may provide insights to CRT response and the relationship between activity changes and survival.

Methods And Results: Patients entered into the LATITUDE remote monitoring system from 2008 to 2012 after receipt of a new CRT-D were eligible.

Predictors for atrial fibrillation detection after cryptogenic stroke: Results from CRYSTAL AF.

Objective: We assessed predictors of atrial fibrillation (AF) in cryptogenic stroke (CS) or transient ischemic attack (TIA) patients who received an insertable cardiac monitor (ICM).

Methods: We studied patients with CS/TIA who were randomized to ICM within the CRYSTAL AF study. We assessed whether age, sex, race, body mass index, type and severity of index ischemic event, CHADS2 score, PR interval, and presence of diabetes, hypertension, congestive heart failure, or patent foramen ovale and premature atrial contractions predicted AF development within the initial 12 and 36 months of follow-up using Cox proportional hazards models.

Infarct Topography and Detection of Atrial Fibrillation in Cryptogenic Stroke: Results from CRYSTAL AF.

Background: Insertable cardiac monitors (ICM) have been shown to detect atrial fibrillation (AF) at a higher rate than routine monitoring methods in patients with cryptogenic stroke (CS). However, it is unknown whether there are topographic patterns of brain infarction in patients with CS that are particularly associated with underlying AF. If such patterns exist, these could be used to help decide whether or not CS patients would benefit from long-term monitoring with an ICM.

Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial.

Objectives: This study investigated the impact of the Medtronic AdaptivCRT (aCRT) (Medtronic, Mounds View, Minnesota) algorithm on 30-day readmissions after heart failure (HF) and all-cause index hospitalizations.

Background: The U.S.

Cryptogenic stroke and underlying atrial fibrillation.

Background: Current guidelines recommend at least 24 hours of electrocardiographic (ECG) monitoring after an ischemic stroke to rule out atrial fibrillation. However, the most effective duration and type of monitoring have not been established, and the cause of ischemic stroke remains uncertain despite a complete diagnostic evaluation in 20 to 40% of cases (cryptogenic stroke). Detection of atrial fibrillation after cryptogenic stroke has therapeutic implications.

Clinical response with adaptive CRT algorithm compared with CRT with echocardiography-optimized atrioventricular delay: a retrospective analysis of multicentre trials.

Aims: Adaptive cardiac resynchronization therapy (aCRT) is a novel algorithm for CRT pacing that provides automatic ambulatory selection between synchronized left ventricular (LV) or bi-ventricular (BiV) pacing and optimization of atrioventricular (AV) and inter-ventricular (VV) delays based on periodic measurement of intrinsic conduction. We aimed to compare the clinical response between aCRT and standard CRT in historical trials.

Methods And Results: The treatment arm of the aCRT trial was compared with a pooled historical control (HC) derived from the CRT arms of four clinical trials (MIRACLE, MIRACLE ICD, PROSPECT, and InSync III Marquis) with respect to the proportion of patients who had an improved clinical composite score (CCS) at the 6-month follow-up.

Investigation of a novel algorithm for synchronized left-ventricular pacing and ambulatory optimization of cardiac resynchronization therapy: results of the adaptive CRT trial.

Background: In patients with sinus rhythm and normal atrioventricular conduction, pacing only the left ventricle with appropriate atrioventricular delays can result in superior left ventricular and right ventricular function compared with standard biventricular (BiV) pacing.

Objective: To evaluate a novel adaptive cardiac resynchronization therapy ((aCRT) algorithm for CRT pacing that provides automatic ambulatory selection between synchronized left ventricular or BiV pacing with dynamic optimization of atrioventricular and interventricular delays.

Methods: Patients (n = 522) indicated for a CRT-defibrillator were randomized to aCRT vs echo-optimized BiV pacing (Echo) in a 2:1 ratio and followed at 1-, 3-, and 6-month postrandomization.

A novel algorithm for individualized cardiac resynchronization therapy: rationale and design of the adaptive cardiac resynchronization therapy trial.

Background: The magnitude of benefit of cardiac resynchronization therapy (CRT) varies significantly among its recipients; approximately 30% of CRT patients do not report clinical improvement. Optimization of CRT pacing parameters can further improve cardiac function, both acutely and chronically. Echocardiographic optimization is used in clinical practice, but it is time and resource consuming.

Inaccuracy in patient handoffs: discrepancies between resident-generated reports and the medical record.

A handoff is the transfer of a patient's care from one provider to another. It usually involves both a verbal and written exchange of information. Although written handoff sheets are critical to good patient care, there is little data on the quality of information they contain.

Staphylococcal toxic shock syndrome 2000-2006: epidemiology, clinical features, and molecular characteristics.

Introduction: Circulating strains of Staphylococcus aureus (SA) have changed in the last 30 years including the emergence of community-associated methicillin-resistant SA (MRSA). A report suggested staphylococcal toxic shock syndrome (TSS) was increasing over 2000-2003. The last population-based assessment of TSS was 1986.

Improved algorithm to detect fluid accumulation via intrathoracic impedance monitoring in heart failure patients with implantable devices.

Background: Intrathoracic impedance fluid monitoring has been shown to predict worsening congestive heart failure (CHF) in patients with implantable devices. We developed and externally validated a modified algorithm to identify worsening heart failure (HF) by using intrathoracic impedance.

Methods And Results: The modified algorithm was developed by using published data from 81 CHF subjects averaging 259 days of follow-up.