Clinical and economic impact of ventricular assist device infections: a real-world claims analysis.

Background: VAD therapy has revolutionized the treatment of end-stage heart failure, but infections remain an important complication. The objective of this study was to characterize the clinical and economic impacts of VAD-specific infections.

Methods: A retrospective analysis of a United States claims database identified members ≥ 18 years with a claim for a VAD implant procedure, at least 6 months of pre-implant baseline data, and 12 months of follow-up between 1 June 2016 and 31 December 2019.

Global best practices consensus: Long-term management of patients with hybrid centrifugal flow left ventricular assist device support.

Objectives: Six months after withdrawal of the HeartWare HVAD System (HVAD; Medtronic) from sale, approximately 4000 patients continue ongoing support with this device. In light of the diminishing experience, this global consensus document summarizes key management recommendations.

Methods: International experts with experience in the management of patients with ongoing HVAD support were invited to summarize key aspects of patient and pump management and highlight differences in the current HeartMate 3 (Abbott Laboratories) ventricular assist device.

The Jarvik 2000 Left Ventricular Assist Device: Results of the United States Bridge to Transplant Trial.

The Jarvik 2000 bridge to transplant investigational device exemption study was a multicentered, prospective study of 150 UNOS status I patients implanted with the Jarvik 2000 between 2005 and 2012. During the study period, there were numerous modifications of the system that included converting from pin to cone bearings. Results were analyzed for three cohorts: total (n = 150), pin (n = 128), and cone (n = 22).

Higher levels of allograft injury in black patients early after heart transplantation.

Black patients suffer higher rates of antibody-mediated rejection and have worse long-term graft survival after heart transplantation. Donor-derived cell free DNA (ddcfDNA) is released into the blood following allograft injury. This study analyzed %ddcfDNA in 63 heart transplant recipients categorized by Black and non-Black race, during the first 200 days after transplant.

Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients.

The study aim was to examine the impact time in therapeutic range (TTR, International Normalized Ratio [INR] 2.0-3.0) has on survival and adverse events in patients receiving the HeartWare HVAD System in the ENDURANCE and ENDURANCE Supplemental Trials.

Comparison of two individualized antithrombotic protocols in HeartWare HVAD recipients.

We previously reported low rates of pump thrombosis and hemorrhagic stroke, but increased bleeding, under our original antithrombosis protocol (P1) in HeartWare recipients. We designed and implemented a revised protocol (P2) to reduce complexity and bleeding. Thrombelastography and PFA-100 guide antiplatelet titration.

Minimally Invasive Left Ventricular Assist Device Insertion Facilitates Subsequent Heart Transplant.

Objective: We have observed that minimally invasive left ventricular assist device (LVAD) insertion leads to more facile re-entry and easier cardiac transplantation. We hypothesize minimally invasive LVAD implantation results in improved outcomes at the time of subsequent heart transplant.

Methods: All adults undergoing cardiac transplantation between October 2015 and March 2019 at our institution were retrospectively reviewed.

A Minimally Invasive Approach to Left Ventricular Assist Device Insertion Facilitates Subsequent Explant.

A minimally invasive approach to left ventricular assist device (LVAD) insertion may benefit patients at the time of implant, but whether the approach to LVAD insertion influences the outcome of subsequent cardiovascular reoperations is unknown. Here we present the case of a 50-year-old male who underwent LVAD insertion through a minimally invasive approach and subsequently had left ventricular recovery. LVAD explant was performed without the use of any blood products or inotropic support.

Outcomes with temporary mechanical circulatory support before minimally invasive centrifugal left ventricular assist device.

Background: Despite improved survival and morbidity after durable left ventricular assist device (dLVAD), outcomes for cardiogenic shock patients are suboptimal. Temporary mechanical circulatory support (tMCS) can permit optimization before dLVAD. Excellent outcomes have been observed using minimally-invasive dLVAD implantation.

FDG PET/CT for Early Detection and Localization of Left Ventricular Assist Device Infection: Impact on Patient Management and Outcome.

Objectives: The feasibility of F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) for the diagnosis of left ventricular assist device (LVAD) infection has been demonstrated. Beyond the diagnoses of LVAD infection, the authors hypothesized that the pattern and site of the infection along its various components may significantly impact clinical management and patient outcome.

Background: In patients with end-stage heart failure, the clinical use of LVAD for destination therapy is on the rise, accompanied by a higher prevalence of infections and serious complications.

Individualized Antithrombotic Therapy in Heartware HVAD Recipients.

There are no evidence-based guidelines for antithrombotic therapy in left ventricular assist device patients. We evaluated the efficacy of a multi-agent, test-guided protocol, which remained consistent throughout our use of the Heartware HVAD. Thrombelastography and platelet function analyzer (PFA)-100 guide antiplatelet titration.

Quantitative Assessment of Inflow Malposition in Two Continuous-Flow Left Ventricular Assist Devices.

Background: We previously investigated preoperative variables associated with qualitative inflow cannula malposition in the HeartMate II (Thoratec-Abbott, Abbott Park, IL) continuous-flow left ventricular assist device. In this report, we assess inflow cannula malposition quantitatively in recipients of both the HeartMate II and the HeartWare (Medtronic-HeartWare, Minneapolis, MN) and examine its association with device thrombosis.

Methods: Malposition was quantified based on angular deviation from a hypothetic ideal inflow cannula position in two orthogonal computed tomography imaging planes.

Systemic Inflammatory Response Syndrome After Contentious-Flow Left Ventricular Assist Device Implantation and Change in Platelet Mitochondrial Membrane Potential.

Background: The objective of this study was to investigate the change of platelet function and platelet mitochondrial membrane potential in contentious-flow left ventricular assist device (CF-LVAD)-implanted heart failure (HF) patients with or without systemic inflammatory response syndrome (SIRS).

Methods And Results: We recruited 31 CF-LVAD patients (16 SIRS and 15 non-SIRS) and 11 healthy volunteers as control. Pre- and post-implantation blood samples were collected.

Comparison of intraplatelet reactive oxygen species, mitochondrial damage, and platelet apoptosis after implantation of three continuous flow left ventricular assist devices: HeartMate II, Jarvik 2000, and HeartWare.

Differences in device design may have an effect on platelet damage and associated clinical complications. We aimed to compare device-specific platelet functionality in 26 heart failure patients supported with three continuous-flow left ventricular assist devices: HeartMate II (n = 8), Jarvik 2000 (n = 9), and HeartWare (n = 9). Intraplatelet reactive oxygen species (ROS) generation, mitochondrial damage, and platelet apoptosis were compared between device types before and after the implantation at every week up to 1 month.

Intraplatelet reactive oxygen species, mitochondrial damage and platelet apoptosis augment non-surgical bleeding in heart failure patients supported by continuous-flow left ventricular assist device.

Non-surgical bleeding (NSB) is the most common clinical complication among heart failure (HF) patients supported by continuous-flow left ventricular assist devices (CF-LVADs). Understanding the role of platelet functionality contributing to NSB after CF-LVAD implantation is crucial for prevention and management of this adverse event. The aim of this study was to examine the role of intraplatelet reactive oxygen species (ROS) and platelet damage on the incidence of bleeding events after CF-LVAD implantation in HF patients.

University of Maryland surgical experience with the Jarvik 2000 axial flow ventricular assist device.

Background: The Jarvik 2000, an axial flow ventricular assist device (VAD), is currently under investigation for bridge to transplant (BTT) indications. The principal advantage of the Jarvik device is intraventricular pump placement. This eliminates the inflow cannula and pump pocket and allows for uncomplicated left ventricular implantation without sternotomy.

Clinical outcomes are similar in pulsatile and nonpulsatile left ventricular assist device recipients.

Background: Despite concerns about the adequacy of support provided by continuous-flow left ventricular assist devices (LVADs), direct comparisons of patient characteristics and outcomes between first-generation pulsatile and second-generation nonpulsatile LVADs are absent. We hypothesized that a nonpulsatile Jarvik 2000 LVAD (Jarvik Heart, Inc, New York, NY) would result in comparable outcomes to those of similarly ill patients implanted with a pulsatile LVAD (Novacor, WorldHeart Inc, Oakland, CA; and HeartMate XVE, Thoratec, Pleasanton, CA).

Methods: We retrospectively compared common pre-LVAD clinical characteristics and indicators of heart failure severity between 13 pulsatile and 14 nonpulsatile LVAD recipients.

Ultrafiltration versus intravenous diuretics for patients hospitalized for acute decompensated heart failure.

Objectives: This study was designed to compare the safety and efficacy of veno-venous ultrafiltration and standard intravenous diuretic therapy for hypervolemic heart failure (HF) patients.

Background: Early ultrafiltration may be an alternative to intravenous diuretics in patients with decompensated HF and volume overload.

Methods: Patients hospitalized for HF with > or =2 signs of hypervolemia were randomized to ultrafiltration or intravenous diuretics.

Acute congestive heart failure in the emergency department.

Acute heart failure and cardiogenic pulmonary edema is a common cause of respiratory distress among patients presenting to the emergency department. The emergency department is frequently the primary entry point into the health care system for these patients and is the site of initial stabilization, evaluation, and management of the patient.Emergency physicians, alongside cardiologists, play a critical role as these patients are treated in the emergency department and transferred to the cardiac ICU.

Allograft inflammatory factor-1 expression correlates with cardiac rejection and development of cardiac allograft vasculopathy.

Background: Standard morphological features of endomyocardial biopsy specimens do not necessarily correlate with the efficacy of immunotherapy or development of cardiac allograft vasculopathy (CAV). We hypothesized that expression of allograft inflammatory factor-1 (AIF-1), a cytokine-inducible, calcium-binding protein associated with vascular smooth muscle cell proliferation, would be associated with allograft rejection and development of CAV.

Methods And Results: A total of 157 endomyocardial biopsy specimens from 26 patients with heart transplants were examined for expression of AIF-1 mRNA by semiquantitative reverse transcription-polymerase chain reaction.