Intranasal Carbetocin Reduces Hyperphagia, Anxiousness, and Distress in Prader-Willi Syndrome: CARE-PWS Phase 3 Trial.

Context: Prader-Willi syndrome (PWS) is a rare genetic disorder characterized by endocrine and neuropsychiatric problems including hyperphagia, anxiousness, and distress. Intranasal carbetocin, an oxytocin analog, was investigated as a selective oxytocin replacement therapy.

Objective: To evaluate safety and efficacy of intranasal carbetocin in PWS.

Impact of preoperative versus postoperative dialysis on left ventricular assist device outcomes: An analysis from the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support database.

Objective: Chronic kidney disease and renal failure are common in patients being considered for left ventricular assist device support. We sought to evaluate the outcomes of patients undergoing left ventricular assist device implantation with preoperative dialysis and those with new-onset postoperative renal failure requiring dialysis.

Methods: All patients (n = 14,090) undergoing primary left ventricular assist device implantation who were listed in the Interagency Registry for Mechanically Assisted Circulatory Support database (2014-2019) were evaluated.

Right Heart Failure Following Left Ventricular Device Implantation: Natural History, Risk Factors, and Outcomes: An Analysis of the STS INTERMACS Database.

Background: Our current understanding of right heart failure (RHF) post-left ventricular assist device (LVAD) is lacking. Recently, a new Interagency Registry for Mechanically Assisted Circulatory Support definition of RHF was introduced. Based on this definition, we investigated natural history, risk factors, and outcomes of post-LVAD RHF.

Evolution of Late Right Heart Failure With Left Ventricular Assist Devices and Association With Outcomes.

Background: A revised definition of right heart failure (RHF) for the Society of Thoracic Surgeons Intermacs database of left ventricular assist devices (LVADs) was introduced in June 2014.

Objectives: The purpose of this study was to determine the prevalence and severity of RHF over time and the association of RHF status at 3 months with 12-month outcomes after LVAD.

Methods: All patients in Society of Thoracic Surgeons Intermacs with follow-up and supported at least 3 months with a continuous flow LVAD implanted between June 2, 2014 and March 31, 2017 without a simultaneous RVAD.

Long-term survival on LVAD support: Device complications and end-organ dysfunction limit long-term success.

Background: Preoperative variables can predict short term left ventricular assist device (LVAD) survival, but predictors of extended survival remain insufficiently characterized.

Method: Patients undergoing LVAD implant (2012-2018) in the Intermacs registry were grouped according to time on support: short-term (<1 year, n = 7,483), mid-term (MT, 1-3 years, n = 5,976) and long-term (LT, ≥3 years, n = 3,015). Landmarked hazard analyses (adjusted hazard ratio, HR) were performed to identify correlates of survival after 1 and 3 years of support.

Impact of thoracotomy approach on right ventricular failure and length of stay in left ventricular assist device implants: an intermacs registry analysis.

Introduction: Traditionally, implantation of Left Ventricular Assist Devices (LVADs) is performed via median sternotomy. Recently, less invasive thoracotomy approaches are growing in popularity as they involve less surgical trauma, potentially less bleeding, and may preserve right ventricular function. We hypothesized implantation of LVADs via thoracotomy has less perioperative right ventricular failure (RVF) and shorter postoperative length of stay (LOS).

STS INTERMACS Database: The Key to Conduct Single-Arm Trials in Advanced Heart Failure Patients.

Background: Safe introduction of novel mechanical circulatory support (MCS) devices into clinical practice is a challenging process. Single-arm trials using a control arm from existing database is an effective alternative that could be applied for regulatory approval. This study analyzes the capability of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database to establish objective performance criteria and select patient population that could be used for future single-arm MCS trials.

Growing Up Fast: Managing Autism Spectrum Disorder and Precocious Puberty.

Case: John is a 4-year-old boy with autism spectrum disorder (ASD) and developmental delay who presented with concerns about increasing aggressive behavior at a follow-up visit with his developmental-behavioral pediatrician. Diagnosis of ASD was made via Diagnostic and Statistical Manual of Mental Disorders, 5th version criteria at initial evaluation at 34 months. Medical history at that time was pertinent for rapid linear growth since the age of 1 and recent pubic hair growth and penile enlargement.

Quantifying the impact from stroke during support with continuous flow ventricular assist devices: An STS INTERMACS analysis.

Introduction: Adverse events, especially strokes, during the implantation of continuous flow durable left ventricular assist devices (LVADs) remain the major barriers to greater application among patients with ambulatory advanced heart failure.

Methods: Between June 2014 and June 2017, a total of 9,489 patients in the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support database received 10,285 continuous flow LVADs, with follow-up through June 2018.

Results: During the follow-up period, 1,515 (16%) patients suffered 1 or more strokes, with a nearly equal frequency of ischemic and hemorrhagic etiology.

The Society of Thoracic Surgeons Intermacs 2019 Annual Report: The Changing Landscape of Devices and Indications.

Background: The field of mechanical circulatory support has been impacted by the approval of new continuous-flow left ventricular assist devices (LVADs) and changes to the United States heart allocation system.

Methods: Primary isolated continuous-flow LVAD implants in The Society of Thoracic Surgeons Intermacs registry from January 2014 through September 2019 were evaluated. Survival and freedom from major adverse events were compared between axial-flow, centrifugal-flow with hybrid levitation (CF-HL), and centrifugal-flow with full magnetic levitation (CF-FML) devices.

Causes and Consequences of Missing Health-Related Quality of Life Assessments in Patients Who Undergo Mechanical Circulatory Support Implantation: Insights From INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support).

Background: Missing health-related quality of life (HRQOL) data in longitudinal studies can reduce precision and power and bias results. Using INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support), we sought to identify factors associated with missing HRQOL data, examine the impact of these factors on estimated HRQOL assuming missing at random missingness, and perform sensitivity analyses to examine missing not at random (MNAR) missingness because of illness severity.

Methods And Results: INTERMACS patients (n=3248) with a preimplantation profile of 1 (critical cardiogenic shock) or 2 (progressive decline) were assessed with the EQ-5D-3L visual analog scale and Kansas City Cardiomyopathy Questionnaire-12 summary scores pre-implantation and 3 months postoperatively.

Biventricular Support With Intracorporeal, Continuous Flow, Centrifugal Ventricular Assist Devices.

Background: The incidence of right ventricular dysfunction requiring right ventricular assist device after left ventricular assist device placement has been reported between 10% to 30%. The mortality rate is higher compared with patients who require left ventricular assist device only; the most effective and safest biventricular assist device remains unknown. We aimed to determine the survival outcomes and frequency of adverse events in patients with two durable, intracorporeal, continuous flow centrifugal pumps for support.

Concomitant mitral valve procedures in patients undergoing implantation of continuous-flow left ventricular assist devices: An INTERMACS database analysis.

Background: Management of existing mitral valve (MV) disease in patients undergoing left ventricular assist device (LVAD) implantation remains controversial.

Methods: Among continuous-flow LVAD patients with moderate to severe mitral regurgitation entered into the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database between April 2008 and March 2014 (n = 4,930), outcomes were compared between patients who underwent MV repair (MVr, n = 252), MV replacement (MVR, n = 11) and no MV procedure (no MVP, n = 4,667). Impact on survival was analyzed by stratified actuarial and hazard function multivariable methodology.

Outcomes of Restrictive and Hypertrophic Cardiomyopathies After LVAD: An INTERMACS Analysis.

Background: Patients with restrictive (RCM) and hypertrophic (HCM) cardiomyopathies are felt to be a difficult population to treat with left ventricular assist device (LVAD) therapy. Scarce data exist on outcomes of continuous-flow (CF) LVAD support in these challenging patient cohorts.

Methods: The Interagency Registry for Mechanically Assisted Circulatory Support Registry was queried for all patients with RCM (n = 94) and HCM (n = 104) who underwent CF LVAD implantation between March 2008 and March 2014.

Eighth annual INTERMACS report: Special focus on framing the impact of adverse events.

Background: The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database now includes >20,000 patients from >180 hospitals.

Methods: The eighth annual report of INTERMACS updates the first decade of patient enrollment.

Results: In the current era, >95% of implants are continuous flow devices.

Effects of MetAP2 inhibition on hyperphagia and body weight in Prader-Willi syndrome: A randomized, double-blind, placebo-controlled trial.

Aims: There are no treatments for the extreme hyperphagia and obesity in Prader-Willi syndrome (PWS). The bestPWS clinical trial assessed the efficacy, safety and tolerability of the methionine aminopeptidase 2 (MetAP2) inhibitor, beloranib.

Materials And Methods: Participants with PWS (12-65 years old) were randomly assigned (1:1:1) to biweekly placebo, 1.

Incorporating Antiracism Coursework into a Cultural Competency Curriculum.

Creating a socially conscious educational environment is an imperative if health care practitioners are to have a significant impact on health inequities. The effects of practitioner bias, prejudice, and discrimination on health and health outcomes have been well documented in the literature. Individuals being trained to provide health care will be entering into an increasingly diverse world and must be equipped with the appropriate knowledge and skills in order to meet the needs of those seeking their care.

Age and gender differences and factors related to change in health-related quality of life from before to 6 months after left ventricular assist device implantation: Findings from Interagency Registry for Mechanically Assisted Circulatory Support.

Background: Gaps in the literature exist regarding health-related quality of life (HRQOL) early after left ventricular assist device (LVAD) surgery. The purposes of our study were to describe HRQOL over time, by age and gender, and identify risk factors for poor HRQOL early after LVAD implant.

Methods: Patients (n = 7,353) from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database received a continuous-flow LVAD as a primary implant at 133 United States hospitals.

Endocrine Effects of Inhaled Corticosteroids in Children.

Inhaled corticosteroids (ICSs) are widely used as first-line treatment for various chronic respiratory illnesses. Advances in devices and formulations have reduced their local adverse effects. However, as delivery of ICSs to the lungs improves, the systemic absorption increases, and an adverse effect profile similar to, although milder than, oral corticosteroids has emerged.

Pump thrombosis in the Thoratec HeartMate II device: An update analysis of the INTERMACS Registry.

Background: Pump thrombosis in durable continuous-flow pumps is a barrier to long-term mechanical circulatory support. Earlier Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data identified an increasing risk of pump thrombosis in recent years with the HeartMate II (HMII) left ventricular assist device. The current analysis examines pump thrombosis in the patient cohort extended through June 2014.

Seventh INTERMACS annual report: 15,000 patients and counting.

The seventh annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes the first 9 years of patient enrollment. The Registry includes >15,000 patients from 158 participating hospitals. Trends in device strategy, patient profile at implant and survival are presented.

A multicenter analysis of clinical hemolysis in patients supported with durable, long-term left ventricular assist device therapy.

Background: Despite the beneficial effects of mechanical circulatory support (MCS), the majority of patients ultimately will have an adverse event. Although hemolysis is common among temporary devices, the incidence and clinical significance of hemolysis in patients managed with long-term, durable left ventricular assist device (LVAD) therapy is largely unknown.

Methods: Data were obtained from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS).

Change in health-related quality of life from before to after destination therapy mechanical circulatory support is similar for older and younger patients: analyses from INTERMACS.

Background: Destination therapy left ventricular assist devices (DT LVADs) are being implanted in older adults on an increasing basis. Older patients have a higher risk for mortality and morbidity post-LVAD, which may impact their health-related quality of life (HRQOL). We aimed to determine the change in HRQOL by age from before implant to 1 year after DT LVAD implant and identify factors associated with the change.

Transfer from planned home birth to hospital: improving interprofessional collaboration.

Women's heightened interest in choice of birthplace and increased rates of planned home birth in the United States have been well documented, yet there remains significant public and professional debate about the ethics of planned home birth in jurisdictions where care is not clearly integrated across birth settings. Simultaneously, the quality of interprofessional interactions is recognized as a predictor of health outcomes during obstetric events. When care is transferred across birth settings, confusion and conflict among providers with respect to roles and responsibilities can adversely affect both outcomes and the experience of care for women and newborns.