HeartWare Ventricular Assist System Research Articles

Long-term follow-up of patients supported with the HeartWare left ventricular assist system.

The aim of the present study is to report our long-term experience with the HeartWare Ventricular Assist System (HVAD). Between July 2009 and February 2018, a total of 103 patients (mean age 50.0±14.4, range 28-74years; 22 females) received HVAD implantation in a single center institution. A total of 26 (25.4%) patients were in cardiogenic shock preoperatively and received extracorporeal life support (ECLS) prior to HVAD implantation. The aim of left ventricular assist device (LVAD)implantation was bridge to transplantation (BT) in 59 (57.3%), destination therapy (DT) in 28 (27.2%), and bridge to decision in16 (15.5%). There were 211.1 total patient years of support. Mean survival was 2.05±2.14years. Kaplan-Meier analysis showed an overall survival rate of 69.7%, 56.7%, 46.0%, and 25.0% at 1, 2, 4, and 8years, respectively. A total of 23 patients (22.3%) died during the hospital stay. Of them 65.2% (15 patients) were preoperatively in cardiogenic shock (INTERMACS 1). Sub-analysis of the BT patients showed a mean survival of 2.45±2.29years with a survival rate of 85.1%, 75.1%, 67.2%, and 44.8% at 1, 2, 4, and 8years, respectively. Among them, 20 patients received heart transplantation on follow-up. Mean survival of DT patients was 2.18±1.91years with a survival rate of 67.9%, 49.0%, and 25.1% at 1, 2, and 4years, respectively. At latest follow-up in September 2018, 26 patients (25.24%) were still on LVAD. A total of five patients completed 6years on LVAD, of them two were supported over 8years. The most common adverse event reported was gastrointestinal bleeding requiring rehospitalization (0.161 EPPY). A total of 19 patients reported disabling stroke. Pump thrombosis was diagnosed in six patients (5.8%) (0.02 EPPY), of them four patients underwent pump exchange. To the best of our knowledge, this is the longest experience with HVAD reported so far. Patients supported with an HVAD show a satisfactory long-term survival. Further multicenter evaluations are needed to confirm these single-center results.

Survival and Functional Status After Bridge-to-Transplant with a Left Ventricular Assist Device.

The use left ventricular assist devices (LVAD) as a bridge-to-transplant (BTT) has become a common modality to treat end-stage heart failure. We sought to examine the impact of BTT on long-term survival and quality of life after heart transplant. The population was all adult patients undergoing isolated heart transplantation in the United States between 2007 and 2017. Inclusion criteria covered BTT patients with a LVAD (only Heartmate II [HMII] or HeartWare Ventricular Assist System [HVAD]) and compared these with patients undergoing de novo heart transplantation. Our primary end-point was survival at 1, 2, and 5 years. Secondary end-points were functional status, return to work, and rates of hospital readmission and graft rejection. Unconditional and conditional survival was estimated with the Kaplan-Meier method. The independent influence of BTT on risk-adjusted mortality was determined using Cox proportional hazards models. In this period, 5,584 patients were bridged with an LVAD and 12,295 underwent de novo transplantation. Unconditional survival was 2% higher in de novo patients at 1, 2, and 5 years. After risk adjustment, BTT was associated with increased mortality at each time point. Unadjusted 5 year survival, conditional on 90 day survival, was similar between groups (82.6% vs. 83.4%; p = 0.15). Functional status, return to work, and unadjusted rates of hospital readmission and graft rejection were similar at 1, 2, 5 years. Bridge-to-transplant with LVADs provides excellent survival and similar quality of life to that of patients undergoing de novo heart transplantation. Bridge-to-transplant patients experience a slightly higher mortality rate within 90 days of transplantation.

Early Outcomes After Heart Transplantation in Recipients Bridged With a HeartMate 3 Device

Left ventricular assist devices are increasingly used as bridge-to-transplantation in eligible patients. The HeartMate 3 (HM3; Abbott Laboratories, Abbot Park, IL) is the latest device to obtain US Food andDrug Administration approval as bridge-to-transplantation. This study examines early outcomes of transplant recipients after HM3 in comparison with recipients bridged with the HeartMate 2 (HM2; Abbott Laboratories) and HeartWare Ventricular Assist System (HVAD; Medtronic, Minneapolis, MN) devices. Using the Organ Procurement and Transplantation Network database, we identified all adult patients who were slated for bridge-to-transplantation with a continuous-flow left ventricular assist devices (HM2, HVAD, or HM3) between April 1, 2015 and January 31, 2018. The primary endpoint was all-cause mortality 6 months after transplantation. The independent influence of the bridging device on outcomes was determined using Cox proportional hazard models. Patients (N= 1,978) were successfully bridged to transplantation with the HM2 (n= 881), HVAD (n= 920), or HM3 (n= 177) device. Six-month mortality rates were similar across these devices (HM2, 5.9%; HVAD, 7.7%; HM3, 4.7%; log-rank p= 0.30). On average HM2 patients were on a left ventricular assist device for 2 months longer (p < 0.01). The HVAD had the lowest rate of device exchange before transplant (p= 0.01). The HM3 had no events of pump thrombosis (p < 0.01). HVAD patients had the lowest rate of device malfunction before to transplant (p < 0.01). Panel reactive antibodies at the time of transplantation were lower for HM3 patients (p < 0.01); however rates of graft rejection at 6 months were not different (p=0.25). The HM3 device provides excellent early outcomes as a bridge to transplantation and may be associated with a reduction in comorbidities. Longer follow-up is needed to better define differences between durable left ventricular assist devices.

Adverse Event Rates Change Favorably Over Time for Patients Bridged With the HeartWare Left Ventricular Assist Device.

The HeartWare Ventricular Assist System (HVAD) provides significant improvements in survival and quality of life, and here, we seek to evaluate temporal differences in the adverse event (AE) rates. Patients (n = 382) in the ADVANCE bridge-to-transplant and continued access protocol trial were assessed for bleeding, cardiac arrhythmia, infection, ischemic and hemorrhagic stroke, and right heart failure during predetermined time periods (≤30, >30-180, >180-365, >365-730, >730-1,095 days) after HVAD implant. The Kaplan-Meier survival at 30 days, 6 months, 1, 2, and 3 years was 98%, 90%, 84%, 71%, and 63%, respectively. There were significantly fewer total AEs in days >30-180 (events per patient year [EPPY] = 5.34) compared with the first 30 days post HVAD implantation (EPPY = 30.36; p < 0.0001). The total AE rate in days >180-365 (EPPY = 4.09) was also significantly lower than the event rate in days >30-180 (EPPY = 5.34; p < 0.0001). Incidence of cardiac arrhythmias, infections, strokes, and right heart failure were highest immediately post implant and lower rates occurred after 6 months. After 1 year, all AEs exhibited stable rates that were comparable up to 3 years of support (all p > 0.05). This changing risk over time has clinically meaningful implications toward improving patient management.

International coordinator survey results on the outpatient management of patients with the HeartWare® ventricular assist system.

While the HeartWare® Ventricular Assist System (HVAS) is a successful therapy for end-stage heart failure, outpatient management methods can vary significantly and require further investigation. A survey to assess the long-term HVAS patient management and monitoring strategies was completed by 36 international heart centers that currently have over 1,450 patients on VAD support either at home or in the hospital. Multiple choice questions examined VAD program characteristics, anticoagulation management, driveline exit-site dressing and showering recommendations, blood pressure and pump parameter monitoring, and patient discharge protocols. Outpatient international normalized ratio (INR) was most frequently measured every 3-4 days (28.6%), and the most frequent schedule for changing driveline exit site dressings was 3 times per week (30.6%). Only 25.7% of centers required their patients to measure blood pressure at home. A subgroup analysis was performed to assess the influence of center experience and larger centers generally had more frequent monitoring compared to smaller centers. This survey showed specific differences in outpatient management strategies that were previously unreported. However, further studies with correlations to patient outcomes are necessary to determine optimal patient management recommendations.

BODY MASS INDEX AND OUTCOMES OF PATIENTS SUPPORTED BY THE HEARTWARE VENTRICULAR ASSIST SYSTEM

Advanced heart failure patients demonstrate significant improvements in survival and quality of life when supported by the HeartWare Ventricular Assist System (HVAD). Patients who are not considered for cardiac transplantation due to comorbid obesity may remain candidates for left ventricular assist

Gastrointestinal Bleeding in Recipients of the HeartWare Ventricular Assist System

This study evaluated gastrointestinal bleeding (GIB) in patients receiving the HeartWare HVAD System (HeartWare Inc., Framingham, Massachusetts) in the pivotal BTT (Bridge to Transplant) trial and under the continued access protocol (CAP). GIB has become a significant problem for recipients of continuous flow device left ventricular assist devices (CF-LVAD). The need for anticoagulation and antiplatelet therapies complicates the management of GIB. Bleeding events from 382 patients with advanced heart failure (140 patients enrolled in the BTT trial, and an additional 242 CAP patients) were analyzed. Post-implant anticoagulation consisted of heparin followed by warfarin at a target international normalized ratio of 2 to 3. Acetylsalicylic acid was recommended at 81 to 325 mg. Overall, 59 of 382 (15.4%) patients experienced 108 GIB events (0.27 events per patient year). Mean time to first bleed was 273.1 days and 86.1% of events occurred beyond 30 days. Freedom from GIB was 84.1% at 1 year. Median international normalized ratio at the time of first bleed was 2.4 ± 1.4. The most common etiology of bleeding identified was arteriovenous malformation and the most common site was the small intestine. Repeat bleeding was infrequent, though GIB patients required more readmissions and developed nondevice infections more frequently. No patients required surgical intervention and no deaths directly related to GIB occurred. Recipients of the HeartWare Ventricular Assist Device System had an incidence of 0.27 GIB/patient year with a freedom from GIB of 84.1% at 1 year. All patients with GIB events were managed with medical and endoscopic therapies, although 31% of patients experienced a recurrence of GIB. No surgical intervention was required. GIB did not impact survival. (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure [ADVANCE]; NCT00751972).

Institutional Experience with the HeartWare Ventricular Assist System in 100 Patients

Background: The implantation of a left ventricular assist device has become a standard treatment option for terminal heart failure. We present our institutional experience with the HeartWare Ventricular Assist System (HVAD) in 100 patients.

Management of pump thrombosis in patients with left ventricular assist devices.

The gradual evolution of left ventricular assist device (LVAD) therapy has resulted in a durable option for patients as either a bridge to transplantation (BTT) or a destination therapy (DT). Outcomes with current continuous-flow devices continue to demonstrate significant patient benefit, not only in enhanced survival but also in improved functional capacity and quality of life. While the lessening of adverse events through time has resulted in more widespread adoption of this therapy, there continues to be unintended consequences, including, most notably, infection, bleeding, and thrombosis. Beginning in 2011, centers and collaborative groups began to observe a significant increase in the incidence of pump thrombosis with the HeartMate II LVAD (Thoratec Corp., Pleasanton, CA, USA). However, this clinical scourge is not limited to the HeartMate II, as the HeartWare Ventricular Assist System (HVAD; HeartWare Inc., Framingham, MA, USA) has also had these same issues, which led to pump modifications and the appreciation of more strict control of blood pressure and anticoagulation with this pump design. We review the current status of the field of mechanical circulatory support in its approach to diagnosis, management, and prevention of LVAD pump thrombosis.

Ventricular assist devices in children

Ventricular assist devices (VADs) have revolutionized heart failure management in adults. Recently, VADs have similarly taken a prominent role in the management of end-stage heart failure in children. The purpose of this review is to describe the indications for VADs in children, types of devices available, current outcomes, and future directions of VAD therapy. There has been a dramatic increase in VAD utilization in children over the last decade. For small children, paracorporeal pneumatic pulsatile pumps (e.g., Berlin Heart EXCOR VAD, Berlin Heart GmbH, Berlin, Germany) are most commonly utilized for long-term support. In older children, intracorporeal continuous flow devices (e.g., HeartMate II Left Ventricular Assist System, Thoratec Corporation, Pleasanton, California, USA and HeartWare Ventricular Assist System, HeartWare Incorporated, Framingham, Massachusetts, USA) have been used and allow the possibility of destination therapy. Other devices, such as the total artificial heart, can be utilized for selected patients. Although overall outcomes of pediatric VADs are favorable, complication rates remain high. The utilization of VADs in complex circulations, such as single ventricle patients, remains infrequent and is associated with a high rate of adverse outcomes. VADs are well-established treatment for end-stage heart failure in children. Further investigation is needed to refine patient selection criteria, minimize complications, and develop additional pediatric-specific devices.

HeartWare Controller Logs A Diagnostic Tool and Clinical Management Aid for the HVAD Pump

Continuous-flow ventricular assist devices (VADs) are a viable therapy for the treatment of end-stage heart failure, offering support for bridge-to-transplantation and destination therapy. As support duration for VADs continues to rise, patient management and device maintenance will play an increasingly crucial role. The HeartWare Ventricular Assist System has currently been implanted in >4,000 patients worldwide. The HeartWare controller stores approximately 30 days of VAD data including pump rotational speed, power consumption, and estimated VAD flow. Routine assessment of controller log files can serve as a pump performance tool and clinical management aid, assisting the clinician to make accurate and timely diagnoses. Here, we discuss the controller's data collection system as well as present the process for evaluation and reporting of controller log files to clinicians.

Comparison of Continuous‐Flow and Pulsatile‐Flow Blood Pumps on Reducing Pulmonary Artery Pressure in Patients With Fixed Pulmonary Hypertension

Pulmonary hypertension (PH) is considered as a risk factor for morbidity and mortality in patients undergoing heart transplantation. Recently, left ventricular assist device (LVAD) implantation has been increasingly used in reducing pulmonary artery pressure (PAP) in patients with PH unresponsive to medical therapy. Herein, we aimed to compare the efficacy of continuous-flow and pulsatile-flow blood pumps on the improvement of PH in mechanical circulatory support patients. Twenty-seven patients with end-stage heart failure who underwent LVAD implantation surgery were enrolled. Fifteen of them (55.6%) had continuous-flow pump (HeartWare Ventricular Assist System, HeartWare, Inc., Miramar, FL, USA), and 12 of them (44.4%) had pulsatile pump (Berlin Heart EXCOR ventricular assist device, Berlin Heart AG, Berlin, Germany). The efficacy of LVADs on the improvement of PH was compared between continuous-flow and pulsatile pumps by the evaluation of systolic PAP, tricuspid annular plane systolic excursion (TAPSE), right ventricular systolic motion (RVSM), right ventricular ejection fraction (RVEF), and grade of tricuspid insufficiency (TI) for each of the study participants. All of the 15 patients who underwent continuous-flow blood pump implantation surgery (Group 1) were male with a mean age of 46.9 ± 11.7 years, and in pulsatile-flow blood pump implanted participants (Group 2), the mean age was 40.6 ± 16.8 years, all of whom were also male (P=0.259). Mean follow-up was 313.7 ± 241.3 days in Group 1 and 448.7 ± 120.7 days in Group 2 (P=0.139). In Group 1, mean preoperative and postoperative systolic PAP were measured as 51.7 ± 12.2 mm Hg and 22.2 ± 3.4 mm Hg, respectively, while those in Group 2 were 54.5 ± 7.5 mm Hg and 33.9 ± 6.4 mm Hg, respectively. A significantly greater decrease in systolic PAP was noticed in patients with continuous-flow blood pumps (P=0.023); however, no statistically significant difference was found when we considered the change in TAPSE between study groups (P=0.112). A statistical significance in the alteration of RVEF, RVSM, and the grade of TI during study visits was not found between the study groups (P=0.472, P=0.887, and P=0.237, respectively). Although the two studied types of LVADs were found to be effective in reducing PAP in heart transplantation candidates with PH, lesser postoperative systolic PAP values were achieved in patients who underwent continuous-flow pump implantation surgery.

HeartWare ventricular assist system for bridge to transplant: Combined results of the bridge to transplant and continued access protocol trial

The HeartWare Ventricular Assist System (HeartWare Inc, Framingmam, MA) is a miniaturized implantable, centrifugal design, continuous-flow blood pump. The pivotal bridge to transplant and continued access protocols trials have enrolled patients with advanced heart failure in a bridge-to-transplant indication. The primary outcome, success, was defined as survival on the originally implanted device, transplant, or explant for ventricular recovery at 180 days. Secondary outcomes included an evaluation of survival, functional and quality of life outcomes, and adverse events. A total of 332 patients in the pivotal bridge to transplant and continued access protocols trial have completed their 180-day primary end-point assessment. Survival in patients receiving the HeartWare pump was 91% at 180 days and 84% at 360 days. Quality of life scores improved significantly, and adverse event rates remain low. The use of the HeartWare pump as a bridge to transplant continues to demonstrate a high 180-day survival rate despite a low rate of transplant. Adverse event rates are similar or better than those observed in historical bridge-to-transplant trials, despite longer exposure times due to longer survival and lower transplant rates.

Left Ventricular Assist Device Implantation in Heart Failure Patients With a Left Ventricular Thrombus

In this report, we share our experience with left ventricular assist device (LVAD) implantation in cases with a left ventricular (LV) thrombus. Over the 3 years, more than 100 end-stage heart failure cases have been treated with LVAD implantation in our center, including 6 patients with a LV thrombus. Three were detected using preoperative transthoracic echocardiography. Fifty percent of the patients had dilated cardiomyopathy and the remaining cases had an ischemic etiology. Double inotropic support with dopamine and dobutamine was used in all, with 3 drugs with the addition of adrenaline in 2 patients. In 4 cases we implanted the HeartWare Ventricular Assist System (HeartWare, Inc., Miramar, Fla, United States) and in the remaining 2 patients, the Berlin Heart EXCOR ventricular assist device (Berlin Heart AG, Berlin, Germany) for biventricular support. In 1 patient the apical ventriculotomy was extended to remove an intertrabecular thrombosis and ventricular septal surface covered with a dacron patch to minimize the thrombogenic potential. Two patients died due to sepsis and multiorgan failure. None of the patients experienced a neurological event, pump thrombosis, or pump malfunction. Two subjects underwent re-explorations due to hemorrhage. Two candidates underwent successfull transplantation without any evidence of thrombosis in the explanted heart or device. We believe that patients with a LV thrombus and preserved right ventricular function are good candidates for implantation of a LVAD after removing the intracavitary thrombus.

Outcomes of HeartWare Ventricular Assist System support in 141 patients: a single-centre experience

A third-generation ventricular assist device, the HeartWare Ventricular Assist System, has demonstrated its reliability and durability in animal models and clinical experience. However, studies of a large series of applications are still lacking. We evaluate the safety and efficacy of the HeartWare pump in 141 patients with end-stage heart failure at a single centre. A total of 141 patients (116 men and 25 women with a mean age of 52 years) in New York Heart Association (NYHA) Class IV received implantation of the HeartWare Ventricular Assist System between August 2009 and April 2011 at the Deutsches Herzzentrum Berlin. The outcomes were measured in terms of laboratory data, adverse events, NYHA functional class and survival during device support. The HeartWare system provided an adequate haemodynamic support for patients both inside and outside the hospital. NYHA class improved to I-II. Organ function and pulmonary vascular resistance improved significantly. In this cohort of patients, 14 patients underwent heart transplantation, one had had the device explanted following myocardial recovery, one had changed to another assist device, 81 were on ongoing support and 44 died. The overall actuarial survival rates at 6 and 12 months were 70 and 67%, respectively, and the 3-, 6- and 12-month survival rates on a left ventricular assist device (LVAD) support for bridge to transplantation patients were 82, 81 and 79%, respectively. Infection and bleeding were the main adverse events. Four patients underwent an LVAD exchange for pump thrombosis. The HeartWare system provides a safe and effective circulatory support in a population with a wide range of body surface areas, with a satisfactory actuarial survival time and an improved quality of life. It can be used for univentricular or biventricular support, being implanted into the pericardial space with simplified surgical techniques.

New Circulatory Support System: Heartware

Through the new developments in medicine, heart failure therapy has advanced to mechanical circulatory support systems. The HeartWare Ventricular Assist System HVAD; HeartWare, Inc.; Miramar, Fla, USA) is a new device that is a centrifugal, intracorporeal, miniaturized and continuous flow pump that serves simple patient use and enhanced life quality. This article reports the midterm results of patients who underwent the heartware support system. We retrospectively compiled our data from December 2010, including 10 patients of mean age 51.8 years with 90% males, 70% of the overall patient cohort had dilated cardiomyopathy and remaining ones, ischemic disease. Mean left ventricular ejection fraction was 20.1% and mean systolic pulmonary artery pressure was 49.2 mm Hg. A single patient was grade 1; seven were grade 2; and remaining ones, grade 3 according to the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) scale. All patients were operated with cardiopulmonary bypass (CPB) with moderate hypothermia. Tricuspid ring annuloplasty was performed in 3 (30%) patients. In one patient we removed a left ventricular thrombus. In a case with severe aortic regurgitation, we placed a simple coaptation stitch at the central portion of the three aortic cusps under the aortic cross clamp. The mean CPB duration was 95.5 minutes. There was no operative or in-hospital mortality. Mean support time was 250.67 days. During the early postoperative period, one patient experienced a minor hemorrhagic neurological event also requiring a tracheostomy due to pneumonia. This patient has completely healed and on follow-up continues a normal life. All patients were asymptomatic regarding heart failure. One patient unfortunately died because of possible pancreatic cancer and sepsis. Two patients underwent transplantations on days 159 and 172 of support. The HVAD system provided effective circulatory support for patients with end-stage heart failure with low adverse event rates. Long-term results are needed particularly for destination therapy candidates.

Invited Commentary

Invited Commentary

Long-term use of the CentriMag® Ventricular Assist System as a right ventricular assist device: a case report

Right ventricular failure (RVF) following implantation of a left ventricular assist system (LVAS) is associated with high morbidity and mortality.( 1-4 ) Numerous centers have reported short-term use of the CentriMag (®) Ventricular Assist System (CVAS) (Levitronix LLC, Waltham, MA) for treatment of cardiogenic shock, decompensated heart failure and right ventricular failure (RVF) following LVAS implantation.( 5-9 ) The present report reviews the clinical course of a patient requiring long-term right ventricular support utilizing the CVAS, following a HeartMate (®) II LVAS (Thoratec Corp. Pleasanton, CA) implantation. Elevated cytotoxic antibody levels complicated the patient's treatment plan by precluding orthotropic heart transplantation. The CVAS operated for 304 days without mechanical difficulty until replaced with the HeartWare (®) Ventricular Assist System (HeartWare Inc. Miramar, FL).

First Experiences With the HeartWare Ventricular Assist System in Children

The purpose of this study is to describe initial experience with a new continuous flow, ventricular assist system in the pediatric population. Seven children (aged 6 to 16 years) received implantation of a novel third-generation, continuous flow, ventricular assist device (HeartWare, HeartWare Inc, Miami Lakes, FL) as a bridge to cardiac transplantation. All children were in terminal heart failure despite inotropic support, and signs of renal or hepatic impairment developed. Six children had dilatative cardiomyopathy and 1 had congenital heart disease (hypoplastic left heart, total cavopulmonary connections with extracardiac conduit). Six patients have been successfully bridged to transplantation. Median support time was 75 days (range, 1 to 136 days). One child is still under continuous mechanical support. None of the patients suffered a thromboembolic event or an infection. The HeartWare assist system can be successfully used as a bridge to transplantation in children and adolescents with end-stage heart failure.

Multicenter Evaluation of an Intrapericardial Left Ventricular Assist System

The aim of this study was to conduct an initial clinical evaluation of the new HeartWare Ventricular Assist System (HeartWare, Inc., Framingham, Massachusetts) in a multicenter, prospective, nonrandomized single-arm clinical trial. Heart failure is a worldwide epidemic. The effectiveness of heart transplantation and medical therapy is limited, resulting in the emergence of mechanical circulatory support as a primary treatment for end-stage heart disease. Left ventricular assist devices that use rotary pumps are small and durable, which might reduce morbidity and mortality during support. Fifty heart transplant candidates with New York Heart Association functional class IV symptoms were supported at 5 international centers by the HeartWare System for 180 days, until heart transplant, myocardial recovery and device explant, or death. Patients who continue to be supported have been followed for a minimum of 2 years. Of the 50 patients, 20 (40%) received transplants, 4 (8%) had the pump explanted after myocardial recovery, and 17 (34%) continue support at 2 years. Nine (18%) patients died during support from sepsis (n = 3), multiple organ failure (n = 3), or hemorrhagic stroke (n = 3). The actual survival at 6, 12, and 24 months was 90%, 84%, and 79%, respectively. In the survivors, measures of quality of life showed a significant improvement over baseline values. Significant improvements were found for recognition memory at 3 months after implant (p = 0.006). The most frequent adverse events were infection and bleeding. Patients with end-stage heart failure can be safely and effectively supported by the HeartWare Ventricular Assist System with improved quality of life and neurocognitive function.