Feasibility study of particulate extracellular matrix (P-ECM) and left ventricular assist device (HVAD) therapy in chronic ischemic heart failure bovine model.

Myocardial recovery with left ventricular assist device (LVAD) support is uncommon and unpredictable. We tested the hypothesis that injectable particulate extracellular matrix (P-ECM) with LVAD support promotes cell proliferation and improves cardiac function. LVAD, P-ECM, and P-ECM + LVAD therapies were investigated in chronic ischemic heart failure (IHF) calves induced using coronary embolization.

Suction prevention and physiologic control of continuous flow left ventricular assist devices using intrinsic pump parameters.

The risk for left ventricular (LV) suction during left ventricular assist devices (LVAD) support has been a clinical concern. Current development efforts suggest LVAD suction prevention and physiologic control algorithms may require chronic implantation of pressure or flow sensors, which can be unreliable because of baseline drift and short lifespan. To overcome this limitation, we designed a sensorless suction prevention and physiologic control (eSPPC) algorithm that only requires LVAD intrinsic parameters (pump speed and power).

Ambulatory extra-aortic counterpulsation in patients with moderate to severe chronic heart failure.

Objectives: The study sought to assess feasibility, safety, and potential efficacy of a novel implantable extra-aortic counterpulsation system (C-Pulse) in functional class III and ambulatory functional class IV heart failure (HF) patients.

Background: 30% to 40% of HF patients suffer from poor functional status and quality of life (QoL) but are not in need of end-stage treatments. We undertook a multicenter single-arm study to assess the C-Pulse System in such patients.

Rotary blood pump control strategy for preventing left ventricular suction.

The risk for left ventricular (LV) suction while maintaining adequate perfusion over a range of physiologic conditions during continuous flow LV assist device (LVAD) support is a significant clinical concern. To address this challenge, we developed a suction prevention and physiologic control (SPPC) algorithm for use with axial and centrifugal LVADs. The SPPC algorithm uses two gain-scheduled, proportional-integral controllers that maintain a differential pump speed (ΔRPM) above a user-defined threshold to prevent LV suction, while maintaining an average reference differential pressure (ΔP) between the LV and aorta to provide physiologic perfusion.

Early feasibility testing and engineering development of a sutureless beating heart connector for left ventricular assist devices.

APK Advanced Medical Technologies (Atlanta, GA) is developing a sutureless beating heart (SBH) left ventricular assist device (LVAD) connector system consisting of anchoring titanium coil, titanium cannula with integrated silicone hemostatic valve, coring and delivery tool, and LVAD locking mechanism to facilitate LVAD inflow surgical procedures. Feasibility testing was completed in human cadavers (n = 4) under simulated normal and hypertensive conditions using saline to observe seal quality in degraded human tissue and assess anatomic fit; acutely in ischemic heart failure bovine model (n = 2) to investigate short-term performance and ease of use; and chronically for 30 days in healthy calves (n = 2) implanted with HeartWare HVAD to evaluate performance and biocompatibility. Complete hemostasis was achieved in human cadavers and animals at LV pressures up to 170 mm Hg.

Development of an extracellular matrix delivery system for effective intramyocardial injection in ischemic tissue.

Biomaterials with direct intramyocardial injection devices have been developed and are being investigated as a potential cardiac regenerative therapy for end-stage ischemic heart failure. Decellularized extracellular matrix (ECM) has been shown to improve cardiac function and attenuate or reverse pathologic remodeling cascades. CorMatrix Cardiovascular, Inc.

Clinical outcomes after implantation of a centrifugal flow left ventricular assist device and concurrent cardiac valve procedures.

Background: Cardiac valve procedures are commonly performed concurrently during implantation of left ventricular assist devices, but the added procedural risk has not been studied in detail.

Methods And Results: Data from patients receiving the HeartWare Ventricular Assist Device in the ADVANCE bridge to transplant (BTT) trial and continued access protocol were reviewed. Of 382 consecutive patients who completed follow-up between August 2008 and June 2013 (mean time on support 389 days, median 271 days), 262 (68.

Extended extra-aortic counterpulsation with the C-Pulse device does not alter aortic wall structure.

The C-Pulse System is an implantable, extra-aortic, non-blood-contacting counterpulsation device, investigational in the United States and intended for use as a heart assist device for heart failure (NYHA class III-ambulatory IV) patients. As long-term effects of this implantable extra-aortic counterpulsation device on the aortic wall structure are not well established, we examined the histological and clinical data of a patient supported on the device for 21 months. A 58-year-old woman diagnosed with nonischemic cardiomyopathy (NYHA III) remained symptomatic despite optimal medical therapy and dual chamber pacemaker.

Heart transplantation.

Heart failure remains a major global problem with approximately 6 million individuals suffering from heart failure in the United States alone. The surgical technique of heart transplantation, popularized by Dr. Norman Shumway, has led to its success and currently remains the best treatment options for patients with end-stage.

Do improvements in substance use and mental health symptoms during treatment translate to long-term outcomes in the opposite domain?

Providers who treat adolescents with co-occurring substance use and mental health issues may prioritize treatment of one set of symptoms believing that improvements in one domain will result in improvements of the other. However, limited empirical data for adolescents provide evidence of such "spillover effects." Using data from 2900 youth in an outpatient treatment, we examined whether during-treatment changes in substance use or mental health symptoms predicted 12-month outcomes in the analogous and opposite domains.

Survival on the heart transplant waiting list: impact of continuous flow left ventricular assist device as bridge to transplant.

Background: Continued donor organ shortage and improved outcomes with current left ventricular assist device (LVAD) technology have increased the number of patients supported with bridge-to-transplantation (BTT) therapy. Using the United Network of Organ Sharing (UNOS) database, we assessed the impact on survival in patients supported with BTT while on the heart transplant waiting list.

Methods: The UNOS database was queried from January 2005 to June 2012 to identify patients listed for heart transplantation as UNOS status 1A or 1B.

Drive-line infections and sepsis in patients receiving the HVAD system as a left ventricular assist device.

Background: Drive-line infections and sepsis lead to significant morbidity and even mortality in patients with ventricular assist devices (VADs). The HeartWare HVAD system is unique compared with other VAD systems in that it has a thin, flexible drive-line and is implanted directly into the pericardial space without the need for a pump pocket. We reviewed 332 patients receiving the HVAD in the pivotal ADVANCE Bridge to Transplant (BTT) trial and Continued Access Protocol (CAP) to determine the incidence of drive-line infections and sepsis.

High-Resolution Imaging Using the VisualSonics Vevo 2100 on Isolated, Perfused Porcine Kidneys on Mechanical Circulatory Support.

Despite many improvements in the field of renal transplantation, the key problem that persists is the lack of organs for all the patients who need kidneys. This problem continues despite the addition of extended criteria donors and donation after cardiac death. Compounding this issue is the high discard rate and there are no good means to truly predict renal function using current pretransplantation testing parameters.

Incidence, risk, and consequences of atrial arrhythmias in patients with continuous-flow left ventricular assist devices.

Background: Although atrial arrhythmias (AAs) are common in heart failure, the incidence of AAs subsequent to the placement of left ventricular assist devices (LVADs) has not been elucidated.

Methods: Patients receiving a HeartMate II LVAD in the bridge to transplant (n = 490) and destination therapy (n = 634) trials were included (n = 1125). AAs requiring treatment were recorded, regardless of symptoms.

Disinhibitory recruitment of NMDA receptor pathways in retina.

Glutamate release at bipolar to ganglion cell synapses activates NMDA and AMPA/kainic acid (KA) ionotropic glutamate receptors. Their relative strength determines the output signals of the retina. We found that this balance is tightly regulated by presynaptic inhibition that preferentially suppresses NMDA receptor (NMDAR) activation.

The association of pretransplant HeartMate II left ventricular assist device placement and heart transplantation mortality.

Previous United Network for Organ Sharing (UNOS) analysis has shown an increase in posttransplant mortality with pretransplant pulsatile-flow left ventricular assist device (LVAD). Recent studies evaluating continuous-flow LVAD demonstrated improved durability, excellent survival, and improved quality of life. This study investigates the association of preheart transplant continuous-flow LVAD placement and posttransplant mortality using the UNOS database.

Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device: a prospective study using the INTERMACS registry (Interagency Registry for Mechanically Assisted Circulatory Support).

Objectives: A post-approval (PA) study for destination therapy (DT) was required by the Food and Drug Administration (FDA) to determine whether results with the HeartMate (HM) II (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial.

Background: New device technology developed in the clinical research setting requires validation in a real-world setting.

Methods: The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry.

Changes in condom use during the first year of HIV treatment in Uganda and the relationship to depression.

Purpose: We examined the effect of antiretroviral therapy (ART), and the predictive role of depression, on condom use with primary partners.

Methods: Data from three studies in Uganda were combined into a sample of 750 patients with a primary sex partner, with 502 starting ART and 248 entering HIV care, and followed for 12 months. Random-effects logistic regression models were used to examine the impact of ART, and the influence of baseline level and change in depression, on condom use with primary partners.

Scientific progress in heart and lung failure, mechanical circulatory support, and transplantation: highlights from the Journal of Heart and Lung Transplantation.

At the Thirty-third Annual Meeting and Scientific Sessions of the International Society of Heart and Lung Transplantation (Montréal, Quebec, Canada), a joint session between the Junior Faculty Council members and the editorial consultants of the Journal of Heart and Lung Transplantation took place to summarize recently published impacting publications in the Journal. The topics reviewed were mechanical circulatory support, heart transplantation, lung transplantation, pulmonary hypertension and pediatrics. The cooperative presentations has been formulated into the present report.

Estimating the causal effects of cumulative treatment episodes for adolescents using marginal structural models and inverse probability of treatment weighting.

Background: Substance use treatment is rarely a one-time event for individuals with substance use disorders. Sustained reductions in substance use and its related symptoms may result from multiple treatment episodes.

Methods: We use a marginal structural model with inverse-probability-of-treatment weighting to estimate the causal effects of cumulative treatment experiences over a period of 9 months on drug use at the end of 1-year among 2870 adolescents receiving care in community-based treatment settings.

An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial.

Background: The HeartWare left ventricular assist device (HVAD, HeartWare Inc, Framingham, MA) is the first implantable centrifugal continuous-flow pump approved for use as a bridge to transplantation. An infrequent but serious adverse event of LVAD support is thrombus ingestion or formation in the pump. In this study, we analyze the incidence of pump thrombus, evaluate the comparative effectiveness of various treatment strategies, and examine factors pre-disposing to the development of pump thrombus.