ACTION-ARC Pediatric and Adult Congenital Heart Disease Ventricular Assist Device Adverse Event Definitions-2023.

Adverse events (AEs) experienced by children and adults with congenital heart disease (CHD) on ventricular assist devices (VADs) are sometimes unique to these populations. The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) and the Academic Research Consortium (ARC) aimed to harmonize definitions of pediatric and CHD AEs for use in clinical trials, registries, and regulatory evaluation. Data from the ACTION registry and adjudication committee were used to adapt general mechanical circulatory support ARC definitions.

American Heart Association Cardiogenic Shock Registry: Design and Implementation.

Background: Cardiogenic shock is a morbid complication of heart disease that claims the lives of more than 1 in 3 patients presenting with this syndrome. Supporting a unique collaboration across clinical specialties, federal regulators, payors, and industry, the American Heart Association volunteers and staff have launched a quality improvement registry to better understand the clinical manifestations of shock phenotypes, and to benchmark the management patterns, and outcomes of patients presenting with cardiogenic shock to hospitals across the United States.

Methods: Participating hospitals will enroll consecutive hospitalized patients with cardiogenic shock, regardless of etiology or severity.

Standardized Definitions for Cardiogenic Shock Research and Mechanical Circulatory Support Devices: Scientific Expert Panel From the Shock Academic Research Consortium (SHARC).

The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened to develop pragmatic consensus definitions useful for the evaluation of clinical trials enrolling patients with cardiogenic shock, including trials evaluating mechanical circulatory support devices. Several in-person and virtual meetings were convened between 2020 and 2022 to discuss the need for developing the standardized definitions required for evaluation of mechanical circulatory support devices in clinical trials for cardiogenic shock patients. The expert panel identified key concepts and topics by performing literature reviews, including previous clinical trials, while recognizing current challenges and the need to advance evidence-based practice and statistical analysis to support future clinical trials.

Hospitalization Patterns and Impact of a Magnetically-Levitated Left Ventricular Assist Device in the MOMENTUM 3 Trial.

Background: In the MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) pivotal trial, the HeartMate 3 (HM3) fully magnetically levitated left ventricular assist device (LVAD) demonstrated superiority over the axial-flow HeartMate II (HMII) LVAD. The patterns and predictors of hospitalizations with the HM3 LVAD have not been characterized.

Objectives: This study sought to determine causes, predictors, and impact of hospitalizations during LVAD support.

Correction: Understanding and Addressing Variation in Health Care-Associated Infections After Durable Ventricular Assist Device Therapy: Protocol for a Mixed Methods Study.

[This corrects the article DOI: 10.2196/14701.].

Center Variability in Patient Outcomes Following HeartMate 3 Implantation: An Analysis of the MOMENTUM 3 Trial.

Background: As left ventricular assist device (LVAD) survival rates continue to improve, evaluating site-specific variability in outcomes can facilitate identifying targets for quality-improvement initiative opportunities in the field.

Methods: Deidentified center-specific outcomes were analyzed for HeartMate 3 (HM3) patients enrolled in the MOMENTUM 3 pivotal and continued access protocol trials. Centers < 25th percentile for HM3 volumes were excluded.

Outcomes With Phosphodiesterase-5 Inhibitor Use After Left Ventricular Assist Device: An STS-INTERMACS Analysis.

Background: Elevated right ventricular afterload following continuous-flow left ventricular assist device (CF-LVAD) may contribute to late right heart failure (LRHF). PDE5i (phosphodiesterase-5 inhibitors) are used to treat pulmonary hypertension and right heart dysfunction after CF-LVAD, but their impact on outcomes is uncertain.

Methods: We queried Interagency Registry for Mechanically Assisted Circulatory Support from 2012 to 2017 for adults receiving a primary CF-LVAD and surviving ≥30 days from index discharge.

Graft Resistance Difference after HVAD to HeartMate 3 Left Ventricular Assist Device Exchange.

Background: A likely consequence of the discontinued distribution and sale of the HVAD System (Medtronic, Minneapolis, MN) will be an increase in replacement with the HeartMate 3 (Abbott, Chicago, IL) left ventricular assist device when device exchange is necessary. If part or all of the HVAD 10-mm-diameter outflow graft is retained during replacement, the HeartMate 3 will have to run at a higher speed than it would with its 14-mm-diameter graft.

Methods: A steady-state, in vitro study was run with 250-mm-long samples of HVAD, HeartMate 3, and half-HVAD/half-HeartMate 3 grafts and additionally 125- and 375-mm-long samples of the HVAD graft.

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.

Primary Graft Dysfunction in Heart Transplant Recipients-Risk Factors and Longitudinal Outcomes.

Before the 33rd Annual International Society for Heart and Lung Transplantation conference, there was significant intercenter variability in definitions of primary graft dysfunction (PGD). The incidence, risk factors, and outcomes of consensus-defined PGD warrant further investigation. We retrospectively examined 448 adult cardiac transplant recipients at our institution from 2005 to 2017.

Creation and Validation of a Novel Sex-Specific Mortality Risk Score in LVAD Recipients.

Background Prior studies have shown that women have worse 3-month survival after receiving a left ventricular assist device compared with men. Currently used prognostic scores, including the Heartmate II Risk Score, do not account for the increased residual risk in women. We used the IMACS (International Society for Heart and Lung Transplantation Mechanically Assisted Circulatory Support) registry to create and validate a sex-specific risk score for early mortality in left ventricular assist device recipients.

Clinical outcomes and healthcare expenditures in the real world with left ventricular assist devices - The CLEAR-LVAD study.

Background: Several distinctly engineered left ventricular assist devices (LVADs) are in clinical use. However, contemporaneous real world comparisons have not been conducted, and clinical trials were not powered to evaluate differential survival outcomes across devices.

Objectives: Determine real world survival outcomes and healthcare expenditures for commercially available durable LVADs.

A comparison of air-cell and gel surgical table pads and an evaluation of the influence of pressure distribution and other factors on pressure injury prevention.

Guidelines for pressure injury prevention consider the use of pressure-redistributing pads to prevent tissue deformation. However, limited research exists to assess the pressure distribution provided by the operating tables and the effectiveness of pressure-redistributing pads in preventing pressure injuries. In this study, we compared the pressure distribution properties of two surgical table pads and identified parameters influencing pressure injury outcomes after a lengthy surgical procedure.

Impact of Pre-Existing Mitral Regurgitation Following Left Ventricular Assist Device Implant.

Objectives: Optimal management of significant mitral regurgitation (SMR) during left ventricular assist device (LVAD) placement remains uncertain. This study evaluates the effect of untreated preop SMR on outcomes following LVAD implant.

Methods: Adults undergoing primary LVAD placement from April 2004 to May 2017 were included.

Gender Differences in Mortality After Left Ventricular Assist Device Implant: A Causal Mediation Analysis Approach.

We used the International Society for Heart and Lung Transplantation (ISHLT) Registry for Mechanically Assisted Circulatory Support (IMACS) database to examine 1) gender differences in post-left ventricular assist device (LVAD) mortality in the contemporary era and 2) preimplant clinical factors that might mediate any observed differences. Adults who received continuous-flow (CF)-LVAD from January 2013 to September 2017 (n = 9,565, age: 56.2 ± 13.

Evaluation of a Health Care Performance Improvement Initiative to Facilitate Optimal Clinical Outcomes in Patients Receiving Ventricular Assist Device Support.

Background: Ventricular assist device (VAD) patients are at high risk for morbidities and mortality. One potentially beneficial component of the Joint Commission VAD Certification process is the requirement that individual VAD programs select 4 performance measures to improve and optimize patients' clinical outcomes.

Problem Statement: Review of patient data after our program's first certification visit in 2008 showed that, compared to national recommendations and published reports, our patients had suboptimal outcomes in 4 areas after device implantation: length of hospital stay, receipt of early (<48 hours) postsurgical physical therapy, driveline infection incidence, and adequacy of nutritional status (prealbumin ≥18 mg/dL).

Delineating Pathways to Death by Multisystem Organ Failure in Patients With a Left Ventricular Assist Device.

Background: This study delineates the sequences of adverse events (AEs) preceding mortality attributed to multisystem organ failure (MSOF) in patients with a left ventricular assist device (LVAD).

Methods: We analyzed 3765 AEs after 536 LVAD implants recorded in The Society of Thoracic Surgeons Intermacs data registry between 2006 and 2015 that resulted in MSOF death. Hierarchical clustering identified and visualized quantitatively unique clusters of patients with similar AE profiles.

Adipose-derived stem cell sheet under an elastic patch improves cardiac function in rats after myocardial infarction.

Objectives: Although adipose-derived stem cells (ADSCs) have shown promise in cardiac regeneration, stable engraftment is still challenging. Acellular bioengineered cardiac patches have shown promise in positively altering ventricular remodeling in ischemic cardiomyopathy. We hypothesized that combining an ADSC sheet approach with a bioengineered patch would enhance ADSC engraftment and positively promote cardiac function compared with either therapy alone in a rat ischemic cardiomyopathy model.

Authorship Correction: Understanding and Addressing Variation in Health Care-Associated Infections After Durable Ventricular Assist Device Therapy: Protocol for a Mixed Methods Study.

[This corrects the article DOI: 10.2196/14701.].

The Preimplantation Psychosocial Evaluation and Prediction of Clinical Outcomes During Mechanical Circulatory Support: What Information Is Most Prognostic?

Background: Psychosocial evaluations are required for long-term mechanical circulatory support (MCS) candidates, no matter whether MCS will be destination therapy (DT) or a bridge to heart transplantation. Although guidelines specify psychosocial contraindications to MCS, there is no comprehensive examination of which psychosocial evaluation domains are most prognostic for clinical outcomes. We evaluated whether overall psychosocial risk, determined across all psychosocial domains, predicted outcomes, and which specific domains appeared responsible for any effects.