Ventricular Assist System Research Articles

HeartWare HVAD: Postoperative issues in our first patient

Ventricular assist devices (VADs) serve as a bridge to heart transplant or destination therapy in end stage heart failure. HeartWare HVAD is a second generation, non pulsatile, magnetically levitated centrifugal pump, which is preload dependent and afterload sensitive. It has an inlet that is cored into the left ventricular wall and an outflow that is attached to a graft which is sutured into the ascending aorta. The Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE) registry has reported a 2 year survival of 76% and 5 year survival of 59%. We present our experience of the first HeartWare 2 HVAD implanted at our institute.

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.

Design Rationale and Preclinical Evaluation of the HeartMate 3 Left Ventricular Assist System for Hemocompatibility

The HeartMate 3 (HM3) left ventricular assist device (LVAD) is designed to support advanced heart failure patients. This centrifugal flow pump has a magnetically levitated rotor, artificial pulse, textured blood-contacting surfaces, optimized fluid dynamics, large blood-flow gaps, and low shear stress. Preclinical tests were conducted to assess hemocompatibility. A computational fluid dynamics (CFD) model guided design for low shear stress and sufficient washing. Hemolysis testing was conducted on six pumps. Plasma-free hemoglobin (PfHb) and modified index of hemolysis (MIH) were compared with HeartMate II (HMII). CFD showed secondary flow path residence times between 27 and 798 min, comparable with main flow residence times between 118 and 587 min; HM3 vs. HMII shear stress exposure above 150 Pa was 3.3 vs. 11 mm within the pump volume and 134 vs. 604 mm on surfaces. In in vitro hemolysis tests at 2, 5, and 10 L/min, average pfHb 6 hours after test initiation was 58, 74, and 157 mg/dl, compared with 112, 123, and 353 mg/dl for HMII. The HM3/HMII ratio of average MIH at 2, 5, and 10 L/min was 0.29, 0.36, and 0.22. Eight 60 day bovine implants were tested with average flow rates from 5.6 to 6.4 L/min with no device failures, thrombosis, or hemolysis. Results support advancing HM3 to clinical trials.

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

Interaction between Warfarin and Linezolid in Patients with Left Ventricular Assist System in Japan.

The purpose of this study was to investigate the possible interaction between warfarin and linezolid in patients with a left ventricular assist system (LVAS) for the treatment of severe heart failure. Patients with LVAS who were treated with linezolid for the treatment of infections from January 2003 to March 2013 were identified from medical records. The impact of linezolid on the clotting function, as well as the dose of warfarin during the first 10 days of linezolid therapy, was investigated. The mean prothrombin time-international normalized ratio (PT-INR) and mean doses of warfarin during 7 days before and 10 days after the initiation of linezolid therapy were calculated for individual patients. The PT-INR per mg of WF dose on the previous day (X) was calculated. The warfarin dose, PT-INR, and warfarin sensitivity index (WSI) value before and after the initiation of linezolid were compared to evaluate the impact of linezolid on the effect of warfarin. Sixteen patients were enrolled in the study. Although the mean PT-INR increased from 3.74 to 4.06, no significant difference was observed (p=0.05). A significant difference was observed in the mean dose of warfarin before and after the initiation of linezolid administration, with a decrease from 3.23 to 2.69 mg/day (p=0.001). In contrast, the mean WSI value significantly increased from 1.37 to 1.82 (p=0.014). After 10 days of linezolid administration, the mean X values increased over the baseline value by 31.7%. These findings suggest that co-administration of linezolid results in increased PT-INR in patients with LVAS treated with warfarin.

Treatment of device thrombus in the HeartWare HVAD: Success and outcomes depend significantly on the initial treatment strategy

Pump thrombosis is a major adverse event in patients supported with a left ventricular assist device (LVAD). Treatment approaches include device exchange, lytic therapy, or augmentation of anticoagulation or antiplatelet therapy. The optimal strategy in the HeartWare HVAD Ventricular Assist System (HeartWare, Framingham, MA) is uncertain, and because few large studies have examined differing treatment outcomes, we have reviewed findings from the Mechanical Circulatory Support Research Network registry. Between March 2009 and August 2014, 175 patients (133 male) underwent implantation of the HeartWare HVAD at institutions that comprise the Mechanical Circulatory Support Research Network. Median age at implant was 59 years (range, 18-76 years). Follow-up was available in all patients for a median of 6 months (maximum, 61 months) and for a total of 163 patient-years of support. There were 36 pump thromboses (using Interagency Registry for Mechanically Assisted Circulatory Support criteria) in 21 patients for a total event rate of 0.22 events/patient-year of support; 13 patients had 1 event, 4 had 2, 2 had 3, 1 had 4, and 1 had 5. The median time to the first thrombosis was 6.4 months, and to each subsequent thrombosis was 4, 3, 2, and 2 months, respectively. Primary treatment success was defined as the patient remaining alive and within the first 30 days of the initial treatment be free from stroke, recurrence of pump thrombosis, device exchange, or urgent transplantation (United Network of Organ Sharing Status 1A). Medical treatment was defined as tissue plasminogen activator, heparin plus glycoprotein IIb/IIIa inhibitor, or heparin alone, not followed by surgical treatment within 72 hours. Initial medical treatment was used in 29 episodes (tissue plasminogen activator in 24, heparin alone in 4, and heparin plus glycoprotein IIb/IIIa in 1) and surgical (device exchange) in 7. Medical treatment was successful in 14 of 29 episodes (48%). Complications of medical treatment included hemorrhagic stroke in 6 patients (21%), need for urgent device exchange/transplant in 6 (21%), and death in 3 (10%). Surgical treatment was successful in all 7 patients (100%). No significant early complications or early deaths occurred after device exchange. In this large multicenter analysis, we observed that medical therapy, as the initial treatment strategy for HeartWare HVAD thrombosis, is associated with low success (48%) and a significant risk of hemorrhagic stroke (21%) and death (10%). However, initial treatment with device exchange was uniformly successful and not associated with significant early morbidity or death. Although the optimal treatment approach for HeartWare HVAD pump thrombosis remains undecided, these data do not support the routine use of medical therapy as an initial treatment strategy.

Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study

BackgroundThe HeartMate 3 left ventricular assist system (LVAS) is intended to provide long-term support to patients with advanced heart failure. The centrifugal flow pump is designed for enhanced hemocompatibility by incorporating a magnetically levitated rotor with wide blood-flow paths and an artificial pulse. ObjectivesThe aim of this single-arm, prospective, multicenter study was to evaluate the performance and safety of this LVAS. MethodsThe primary endpoint was 6-month survival compared with INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support)-derived performance goal. Patients were adults with ejection fraction ≤25%, cardiac index ≤2.2 l/min/m2 without inotropes or were inotrope-dependent on optimal medical management, or listed for transplant. ResultsFifty patients were enrolled at 10 centers. The indications for LVAS support were bridge to transplantation (54%) or destination therapy (46%). At 6 months, 88% of patients continued on support, 4% received transplants, and 8% died. Thirty-day mortality was 2% and 6-month survival 92%, which exceeded the 88% performance goal. Support with the fully magnetically levitated LVAS significantly reduced mortality risk by 66% compared with the Seattle Heart Failure Model–predicted survival of 78% (p = 0.0093). Key adverse events included reoperation for bleeding (14%), driveline infection (10%), gastrointestinal bleeding (8%), and debilitating stroke (modified Rankin Score >3) (8%). There were no pump exchanges, pump malfunctions, pump thrombosis, or hemolysis events. New York Heart Association classification, 6-min walk test, and quality-of-life scores showed progressive and sustained improvement. ConclusionsThe results show that the fully magnetically levitated centrifugal-flow chronic LVAS is safe, with high 30-day and 6-month survival rates, a favorable adverse event profile, and improved quality of life and functional status. (HeartMate 3™ CE Mark Clinical Investigation Plan [HM3 CE Mark]; NCT02170363)

(2) - Long Term Support of Patients Receiving an LVAD for Advanced Heart Failure: A Subgroup Analysis of the Registry to Evaluate the HeartWare® Left Ventricular Assist System (The REVOLVE Registry)

(2) - Long Term Support of Patients Receiving an LVAD for Advanced Heart Failure: A Subgroup Analysis of the Registry to Evaluate the HeartWare® Left Ventricular Assist System (The REVOLVE Registry)

Gastrointestinal Bleeding in Recipients of the HeartWare Ventricular Assist System

ObjectivesThis 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). BackgroundGIB 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. MethodsBleeding 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. ResultsOverall, 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. ConclusionsRecipients 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.

Early feasibility testing and engineering development of the transapical approach for the HeartWare MVAD ventricular assist system.

Implantation of ventricular assist devices (VADs) for the treatment of end-stage heart failure (HF) falls decidedly short of clinical demand, which exceeds 100,000 HF patients per year. Ventricular assist device implantation often requires major surgical intervention with associated risk of adverse events and long recovery periods. To address these limitations, HeartWare, Inc. has developed a platform of miniature ventricular devices with progressively reduced surgical invasiveness and innovative patient peripherals. One surgical implant concept is a transapical version of the miniaturized left ventricular assist device (MVAD). The HeartWare MVAD Pump is a small, continuous-flow, full-support device that has a displacement volume of 22 ml. A new cannula configuration has been developed for transapical implantation, where the outflow cannula is positioned across the aortic valve. The two primary objectives for this feasibility study were to evaluate anatomic fit and surgical approach and efficacy of the transapical MVAD configuration. Anatomic fit and surgical approach were demonstrated using human cadavers (n = 4). Efficacy was demonstrated in acute (n = 2) and chronic (n = 1) bovine model experiments and assessed by improvements in hemodynamics, biocompatibility, flow dynamics, and histopathology. Potential advantages of the MVAD Pump include flow support in the same direction as the native ventricle, elimination of cardiopulmonary bypass, and minimally invasive implantation.

Results of the post-market Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE)

The post-market Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE) is an investigator-initiated registry established to collect post-CE Mark Trial clinical data on patients receiving a HeartWare ventricular assist device (HVAD) in the European Union and Australia. The ReVOLVE is a multi-center, prospective, single-arm registry performed at seven centers in Europe and two in Australia. Herein we describe a total of 254 commercial HVAD implants according to labeled indications between February 2009 and November 2012. Summary statistics included patients' demographics, adverse events, length of support and outcomes. Compared with the clinical trial supporting the CE Mark of the HeartWare system, patient selection differed in that patients were older, and there were higher proportions of females and patients with idiopathic cardiomyopathies in the ReVOLVE cohort. Duration of support ranged from 1 to 1,057 days, with a mean of 363 ± 280 days (median 299.5 days). Transplantation was done in 56 patients (22%), explant for recovery was performed in 3 patients (1%), 43 died while on support (17%), and 152 (60%) remain on the device. Success in patients with the HeartWare system was 87% at 6 months, 85% at 1 year, 79% at 2 years and 73% at 3 years. Adverse event rates were low, comparable or improved when compared to the CE Mark Trial. Real-world use of the HeartWare system continues to demonstrate excellent clinical outcomes in patients supported with the device.

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 miniaturized intrapericardial ventricular assist device: advantages and adverse events in comparison to contemporary devices

Increasing incidence of end-stage heart failure and limited availability of donor organs have led to longer waiting times for cardiac transplantation and subsequently increasing mortality. Ventricular assist device therapy is fast becoming an accepted alternative treatment to treat end-stage heart failure and is being implemented as a bridge to decision, bridge to myocardial recovery, bridge to heart transplantation or as a destination therapy. LVADs not only enable hemodynamic stabilization and recovery of secondary organ failure in severely ill patients, but have also been shown to reduce pulmonary vascular resistance in nontransplantable candidates. Technology of ventricular assist devices has evolved over several decades of time and generations of devices. The HVAD® Pump (HeartWare International, Inc., MA, USA) is a third-generation, miniaturized, continuous-flow ventricular assist device. Due to its miniaturized housing and intrapericardial placing, it can be used proficiently to support the right ventricle and has also demonstrated great utility in minimally invasive and off-pump implantation, exchange and explantation. It is favored for similar reasons in adolescents and in heart failure due to complex congenital heart disease. The purpose of this article is to review the clinical use of HeartWare® Ventricular Assist System (HeartWare System; HeartWare International, Inc.) with different strategies pertaining to its advantages and adverse events in comparison with contemporary devices.

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.

Impact of Pump Replacement on Outcome in Advanced Heart Failure Patients With Left Ventricular Assist System

Pump thrombosis is one of the major adverse events associated with the use of a left ventricular assist system (LVAS) in patients with advanced heart failure. We investigated the clinical implication of pump replacement because of thrombus formation. This study included 87 patients who underwent implantation of a Nipro (Toyobo) pulsatile extracorporeal LVAS intended as a bridge to transplantation and were alive more than 3 months after implantation. The pump of this device is translucent, and daily evaluation for signs of thrombus formation was performed. Pump replacement was performed for significant thrombus formation that became visible. Data collection including demographics as well as hematologic values were performed 1 day before (baseline) and 3 months after implantation, and all patients were followed for 2 years or until death. At 3 months after LVAS implantation, 41 patients (47.1%) had undergone pump replacement because of pump thrombus. Baseline body surface area <1.63 m(2) was a significant predictor of pump replacement (hazard ratio [HR] 2.15, P = 0.04). At 3 months after implantation, there was a significantly higher incidence of stroke (P < 0.05) as well as a significantly greater decrease in body weight (F = 4.92, P = 0.03) in patients who underwent pump replacement as compared to those without. The 2-year mortality after implantation was 26.4%. Multivariate Cox regression analysis showed that pump replacement within 3 months after implantation was an independent predictor of mortality (HR 2.50, P = 0.03). In conclusion, pump replacement for thrombus formation may have a strong association with worse outcome. Our results reconfirm the clinical importance of device thrombus in the management of LVAS.

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

BackgroundIn this report, we share our experience with left ventricular assist device (LVAD) implantation in cases with a left ventricular (LV) thrombus. MethodOver 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. ResultsTwo 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. ConclusionWe 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.