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Background: The Impella device is a continuous axial flow pump which provides hemodynamic support by expelling blood into the aorta. The manufacturer recommends using dextrose-based heparin containing solutions as the default purge. As an alternative to anticoagulant solutions, a bicarbonate-based purge solution has been proposed with limited data substantiating adequate protection and durability. Objective: To assess the impact of a bicarbonate-based purge solution on Impella pump thrombosis and bleeding outcomes. Methods: Single-center, retrospective study of cardiogenic shock patients who received an Impella between December 2020 through September 2021. Patients were evaluated based on whether they received bicarbonate-based purge solutions or remained on heparin-based purge solutions. The primary outcome was the rate of Impella pump thrombosis, defined as multiple purge pressures greater than 800 mm Hg. Secondary outcomes included incidence of bleeding defined as a drop in Hgb of at least 2 g/dL along with use of blood products and supratherapeutic anticoagulation defined as an aPTT of greater than 70 seconds. Results: Forty-three patients received bicarbonate-based purge solutions and 49 controls received heparin. The incidence of purge thrombosis by purge pressure threshold was similar between the two groups (16.3% vs 12.2%, P = 0.58). The rate of bleeding was lower with bicarbonate-based purge (27.9% vs 65.3%, P < 0.05) driven by a drop in Hgb of more than 2 g/dL. The rate of supratherapeutic anticoagulation was higher in the heparin arm (65.3% vs 27.9%, P < 0.05) Conclusion and Relevance: Nonanticoagulant purge alternatives offer the potential to reduce bleeding complications and laboratory monitoring burden while maintaining durability. [ABSTRACT FROM AUTHOR]

The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices. (J Thorac Cardiovasc Surg 2022;-:1–8) [ABSTRACT FROM AUTHOR]

Aims: Continuous‐flow left ventricular assist devices (LVADs) as destination therapy (DT) are a recommended treatment by National Institute for Health and Care Excellence England for end‐stage heart failure patients ineligible for cardiac transplantation. Despite the fact that DT is frequently used as an LVAD indication across other major European countries and the United States, with consistent improvements in quality‐of‐life and longevity, National Health Service (NHS) England does not currently fund DT, mainly due to concerns over cost‐effectiveness. On the basis of the recently published ENDURANCE Supplemental Trial studying DT patients, we assessed for the first time the cost‐effectiveness of DT LVADs compared with medical management (MM) in the NHS England. Methods and results: We developed a Markov multiple‐state economic model using NHS cost data. LVAD survival and adverse event rates were derived from the ENDURANCE Supplemental Trial. MM survival was based on Seattle Heart Failure Model estimates in the absence of contemporary clinical trials for this population. Incremental cost‐effectiveness ratios (ICERs) were calculated over a lifetime horizon. A discount rate of 3.5% per year was applied to costs and benefits. Deterministic ICER was £46 207 per quality‐adjusted life year (QALY). Costs and utilities were £204 022 and 3.27 QALYs for the LVAD arm vs. £77 790 and 0.54 QALYs for the MM arm. Sensitivity analyses confirmed robustness of the primary analysis. Conclusions: The implantation of the HeartWare™ HVAD™ System in patients ineligible for cardiac transplantation as DT is a cost‐effective therapy in the NHS England healthcare system under the end‐of‐life willingness‐to‐pay threshold of £50 000/QALY, which applies for VAD patients. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Cardiogenic shock from refractory right ventricular (RV) failure during left ventricular assist device placement is associated with high morbidity and mortality. The addition of extracorporeal membrane oxygenation to RV mechanical assistance may help RV recovery and lead to improved outcomes. METHODS: We retrospectively reviewed all implanted continuous-flow left ventricular assist devices from April 2009 to June 2013. RV mechanical support was utilized for RV failure defined as haemodynamic instability despite vasopressors, pulmonary vascular dilators and inotropic therapy. RV assist devices were utilized with and without in-line membrane oxygenation. RESULTS: During the study period, 267 continuous-flow left ventricular assist devices were implanted. RV mechanical support was utilized in 27 (10%) patients; 12 (46%) had the addition of in-line extracorporeal membrane oxygenation. The mean age of patients with a right ventricular assist device with membrane oxygenation was lower than that in patients with a right ventricular assist device alone (45.6 ± 15.9 vs 64.6 ± 6.5, P = 0.001). Support was weaned in 66% (10 of 15) of patients with right ventricular assist device (RVAD) alone vs 83% (10 of 12) of those with RVAD with membrane oxygenation (P = 0.42). The RVAD was removed after 10.4 ± 9.4 vs 5 ± 2.99 days for patients with a RVAD with membrane oxygenation (P = 0.1). Patients with RVAD with membrane oxygenation had a 30-day mortality rate of 8 vs 47% for those with RVAD alone (P = 0.04). The survival rate after discharge was 86, 63 and 54% at 3, 6 and 12 months for both groups combined. CONCLUSIONS: Patients with a RVAD with membrane oxygenation support for acute RV failure after continuous-flow left ventricular assist device implantation had a lower 30-day mortality than those with a RVAD alone. Patients who survive to discharge have a reasonable 1-year survival. Combining membrane oxygenation with RVAD support appears to offer a short-term survival benefit in patients with RV failure after continuous-flow left ventricular assist device implantation. [ABSTRACT FROM AUTHOR]

Left ventricular assist devices (LVADs) are excellent therapies for advanced heart failure patients either bridged to transplant or for lifetime use. LVADs also allow for reverse remodeling of the failing heart that is often associated with functional improvement. Indeed, growing enthusiasm exists to better understand this population of patients, whereby the LVAD is used as an adjunct to mediate myocardial recovery. When patients achieve benchmarks suggesting that they no longer need LVAD support, questions related to the discontinuation of LVAD therapy become front and center. The purpose of this review is to provide a surgical perspective on the practical and technical issues surrounding LVAD deactivation. [ABSTRACT FROM AUTHOR]

The prevalence of end-stage heart failure and patients who could benefit from heart transplantation requires an expansion of the donor pool, relying on the transplant community to continually re-evaluate and expand the use of extended criteria donor organs. Introduction of new technologies such as the Paragonix SherpaPak Cardiac Transport System aids in this shift. We seek to analyze the impact of the SherpaPak system on recipient outcomes who receive extended criteria organs in the GUARDIAN-Heart Registry. Between October 2015 and December 2022, 1,113 adults from 15 US centers receiving donor hearts utilizing either SherpaPak (n = 560) or conventional ice storage (ice, n = 453) were analyzed from the GUARDIAN-Heart Registry using summary statistics. A previously published set of criteria was used to identify extended criteria donors, which included 193 SherpaPak and 137 ice. There were a few baseline differences among recipients in the 2 cohorts; most notably, IMPACT scores, distance traveled, and total ischemic time were significantly greater in SherpaPak, and significantly more donor hearts in the SherpaPak cohort had >4 hours total ischemia time. Posttransplant mechanical circulatory support utilization (SherpaPak 22.3% vs ice 35.0%, p = 0.012) and new extracorporeal membrane oxygenation/ventricular assist device (SherpaPak 7.8% vs ice 15.3%, p = 0.033) was significantly reduced, and the rate of severe primary graft dysfunction (SherpaPak 6.2% vs ice 13.9%, p = 0.022) was significantly reduced by over 50% in hearts preserved using SherpaPak. One-year survival between cohorts was similar (SherpaPak 92.9% vs ice 89.6%, p = 0.27). This subgroup analysis demonstrates that SherpaPak can be safely used to utilize extended criteria donors with low severe PGD rates. [ABSTRACT FROM AUTHOR]

The article discusses a study that examined the occurrence of pump thrombosis and elevated lactate dehydrogenase (LDH) levels, LDH levels presaging thrombosis and associated hemolysis, and outcomes of different management strategies in patients who received the HeartMate II left ventricular assist device. Findings confirmed pump thromboses in 66 patients, and 36 thromboses in unique devices were suspected. The increasing rate of pump thrombosis related to the use of the device is noted.

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. Determine real world survival outcomes and healthcare expenditures for commercially available durable LVADs. Using a retrospective observational cohort design, Medicare claims files were linked to manufacturer device registration data to identify de-novo, durable LVAD implants performed between January 2014 and December 2018, with follow-up through December 2019. Survival outcomes were compared using a Cox proportional hazards model stratified by LVAD type and validated using propensity score matching. Healthcare resource utilization was analyzed across device types by using nonparametric bootstrap analysis methodology. Primary outcome was survival at 1-year and total Part A Medicare payments. A total of 4,195 de-novo LVAD implants were identified in fee-for-service Medicare beneficiaries (821 HeartMate 3; 1,840 HeartMate II; and 1,534 Other-VADs). The adjusted hazard ratio for mortality at 1-year (confirmed in a propensity score matched analysis) for the HeartMate 3 vs HeartMate II was 0.64 (95% CI; 0.52–0.79, p < 0.001) and for the HeartMate 3 vs Other-VADs was 0.51 (95% CI; 0.42–0.63, p < 0.001). The HeartMate 3 cohort experienced fewer hospitalizations per patient-year vs Other-VADs (respectively, 2.8 vs 3.2 EPPY hospitalizations, p < 0.01) and 6.1 fewer hospital days on average (respectively, 25.2 vs 31.3 days, p < 0.01). The difference in Medicare expenditures, conditional on survival, for HeartMate 3 vs HeartMate II was -$10,722, p < 0.001 (17.4% reduction) and for HeartMate 3 vs Other-VADs was -$17,947, p < 0.001 (26.1% reduction). In this analysis of a large, real world, United States. administrative dataset of durable LVADs, we observed that the HeartMate 3 had superior survival, reduced healthcare resource use, and lower healthcare expenditure compared to other contemporary commercially available LVADs. [ABSTRACT FROM AUTHOR]

Mitral regurgitation (MR) determines pathophysiology and outcome in advanced heart failure. The impact of left ventricular assist device (LVAD) placement on clinically significant MR and its contribution to long-term outcomes has been sparsely evaluated. We evaluated the effect of clinically significant MR on patients implanted in the MOMENTUM 3 trial with either the HeartMate II (HMII) or the HeartMate 3 (HM3) at 2 years. Clinical significance was defined as moderate or severe grade MR determined by site-based echocardiograms. Of 927 patients with LVAD implants without a prior or concomitant mitral valve procedure, 403 (43.5%) had clinically significant MR at baseline. At 1-month of support, residual MR was present in 6.2% of patients with HM3 and 14.3% of patients with HMII (relative risk = 0.43; 95% CI, 0.22–0.84; p = 0.01) with a low rate of worsening at 2 years. Residual MR at 1-month post-implant did not impact 2-year mortality for either the HM3 (hazard ratio [HR],1.41; 95% CI, 0.52–3.89; p = 0.50) or HMII (HR, 0.91; 95% CI, 0.37–2.26; p = 0.84) LVAD. The presence or absence of baseline MR did not influence mortality (HM3 HR, 0.86; 95% CI, 0.56–1.33; p = 0.50; HMII HR, 0.81; 95% CI, 0.54–1.22; p = 0.32), major adverse events or functional capacity. In multivariate analysis, severe baseline MR (p = 0.001), larger left ventricular dimension (p = 0.002), and implantation with the HMII instead of the HM3 LVAD (p = 0.05) were independently associated with an increased likelihood of persistent MR post-implant. Hemodynamic unloading after LVAD implantation improves clinically significant MR early, sustainably, and to a greater extent with the HM3 LVAD. Neither baseline nor residual MR influence outcomes after LVAD implantation. [ABSTRACT FROM AUTHOR]

Background: The HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (Abbott) is a centrifugal, fully magnetically levitated, continuous-flow blood pump engineered to enhance hemocompatibility and reduce shear stress on blood components. The MOMENTUM 3 trial (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) compares the HM3 LVAS with the HeartMate II (HMII) LVAS (Abbott) in advanced heart failure refractory to medical management, irrespective of therapeutic intention (bridge to transplant versus destination therapy). This investigation reported its primary outcome in the short-term cohort (n=294; 6-month follow-up), demonstrating superiority of the HM3 for the trial primary end point (survival free of a disabling stroke or reoperation to replace the pump for malfunction), driven by a reduced need for reoperations. The aim of this analysis was to evaluate the aggregate of hemocompatibility-related clinical adverse events (HRAEs) between the 2 LVAS.Methods: We conducted a secondary end point evaluation of HRAE (survival free of any nonsurgical bleeding, thromboembolic event, pump thrombosis, or neurological event) in the short-term cohort (as-treated cohort n=289) at 6 months. The net burden of HRAE was also assessed by using a previously described hemocompatibility score, which uses 4 escalating tiers of hierarchal severity to derive a total score for events encountered during the entire follow-up experience for each patient.Results: In 289 patients in the as-treated group (151 the HM3 and 138 the HMII), survival free of any HRAE was achieved in 69% of the HM3 group and in 55% of the HMII group (hazard ratio, 0.62; confidence interval, 0.42-0.91; P=0.012). Using the hemocompatibility score, the HM3 group demonstrated less pump thrombosis requiring reoperation (0 versus 36 points, P<0.001) or medically managed pump thrombosis (0 versus 5 points, P=0.02), and fewer nondisabling strokes (6 versus 24 points, P=0.026) than the control HMII LVAS. The net hemocompatibility score in the HM3 in comparison with the HMII patients was 101 (0.67±1.50 points/patient) versus 137 (0.99±1.79 points/patient) (odds ratio, 0.64; confidence interval, 0.39-1.03; P=0.065).Conclusions: In this secondary analysis of the MOMENTUM 3 trial, the HM3 LVAS demonstrated greater freedom from HRAEs in comparison with the HMII LVAS at 6 months.Clinical Trial Registration: URL: http://clinicaltrials.gov. Unique identifier: NCT02224755. [ABSTRACT FROM AUTHOR]

Background Right ventricular failure (RVF) increases morbidity and mortality. The RECOVER RIGHT study evaluated the safety and efficacy of a novel percutaneous right ventricular assist device, the Impella RP (Abiomed, Danvers, MA), in a prospective, multicenter trial. Methods Thirty patients with RVF refractory to medical treatment received the Impella RP device at 15 United States institutions. The study population included 2 cohorts: 18 patients with RVF after left ventricular assist device (LVAD) implantation (Cohort A) and 12 patients with RVF after cardiotomy or myocardial infarction (Cohort B). The primary end point was survival to 30 days or hospital discharge (whichever was longer). Major secondary end points included indices of safety and efficacy. Results The patients (77% male) were a mean age of 59 ± 15 years, 53% had diabetes, 88.5% had a history of congestive heart failure, and 37.5% had renal dysfunction. Patients were on an average of 3.2 inotropes/pressors. Device delivery was achieved in all but 1 patient. Hemodynamics improved immediately after initiation of Impella RP support, with an increase in cardiac index from 1.8 ± 0.2 to 3.3 ± 0.23 liters/min/m 2 ( p < 0.001) and a decrease in central venous pressure from 19.2 ± 4 to 12.6 ± 1 mm Hg ( p < 0.001). Patients were supported for an average of 3.0 ± 1.5 days (range, 0.5–7.8 days). The overall survival at 30 days was 73.3%. All patients discharged were alive at 180 days. Conclusions In patients with life-threatening RVF, the novel percutaneous Impella RP device was safe, easy to deploy, and reliably resulted in immediate hemodynamic benefit. These data support its probable benefit in this gravely ill patient population. [ABSTRACT FROM AUTHOR]

Background Management of existing aortic insufficiency (AI) and mechanical aortic valves in patients undergoing left ventricular assist device (LVAD) implantation remains controversial. Surgical options to address these issues include closure, repair or replacement of the valve. Methods Continuous-flow LVAD/biventricular VAD patients entered into the INTERMACS database between June 2006 and December 2012 were included ( n = 5,344) in this analysis. Outcomes were compared between patients who underwent aortic valve (AV) closure ( n = 125), repair ( n = 95) and replacement ( n = 85). Results Among patients who underwent an AV procedure, actuarial survival was significantly reduced for AV closures (63.2%) compared with AV repairs (76.8%) and replacements (71.8%) ( p = 0.0003). Differences were greater between groups when only INTERMACS Level 1 or 2 patients were analyzed ( p = 0.003). After multivariate adjustment, AV closure remained a significant risk factor for mortality (hazard ratio = 1.87, 95% confidence interval 1.39 to 2.53, p < 0.0001). At 6 to 12 months post-operatively, moderate to severe AI developed in 19%, 5%, 9% and 10% of patients with available echocardiography who underwent repair, closure, replacement and no intervention, respectively ( p < 0.0001). Competing outcomes demonstrate that, at 1-year, fewer patients with AV closures were transplanted compared with patients with repairs/replacements (14% vs 19%). No differences were observed between groups with respect to cause of death, re-hospitalization, right heart failure or stroke. Conclusions AV closure was associated with increased mortality when compared with repair or replacement in patients with AI who underwent LVAD insertion. The reasons for this association require further investigation. This is the largest study to date to examine concomitant AV procedures in patients undergoing LVAD insertion. [ABSTRACT FROM AUTHOR]

Background: Performing concomitant tricuspid valve procedures (TVPs) in left ventricular assist device (LVAD) patients with significant pre-operative tricuspid regurgitation (TR) is controversial, and no studies have been large enough to definitively guide therapy. Methods: Between January 2006 and September 2012, 2,196 patients with moderate to severe pre-operative TR from 115 institutions underwent implantation of a continuous-flow left ventricular assist device (LVAD) as reported by The Society of Thoracic Surgeons National Database. Of these, 588 (27%) underwent a concomitant TVP. Inverse probability weighting based on propensity score was used to adjust for differences between the LVAD alone and LVAD+TVP groups, and outcomes were compared. Results: Most patients in the LVAD+TVP group underwent an annuloplasty alone (81.1%). Concomitant TVP did not affect risk of post-operative right VAD insertion (risk ratio [RR], 0.81; 95% confidence interval [CI], 0.49–1.36; p = 0.4310) or death (RR, 0.95; 95% CI, 0.68–1.33; p = 0.7658). However, TVP was associated with an increased risk for post-operative renal failure (RR, 1.53; 95% CI, 1.13–2.08; p = 0.0061), dialysis (RR, 1.49; 95% CI, 1.03–2.15; p = 0.0339), reoperation (RR, 1.24; 95% CI, 1.07–1.45; p = 0.0056), greater total transfusion requirement (RR, 1.03; 95% CI, 1.01–1.05; p = 0.0013), and hospital length of stay > 21 days (RR, 1.29; 95% CI, 1.16–1.43; p < 0.0001). Time on the ventilator and intensive care unit length of stay were also significantly prolonged for the LVAD+TVP group. Conclusions: Performing a concomitant TVP for continuous-flow LVAD patients with moderate to severe TR did not reduce early death or right VAD requirement and was associated with worse early post-operative outcomes. These data caution against routine concomitant TVP based solely on degree of pre-operative TR and suggest that additional selection criteria are needed to identify those patients in whom concomitant TVP may prevent post-operative right ventricular failure. [Copyright &y& Elsevier]

The article focuses on the slope of the anterior mitral valve leaflet (SLAM) as measurement of left ventricular (LV) unloading for left ventricular assist devices (LVAD) and systolic dysfunction. Topics covered include the multiple trans-thoracic echocardiographic (TTE) methods for assessing LV filling pressures and the serum pro-brain natriuretic peptide (BNP) measurement.

Background: Pump thrombosis in patients with left ventricular assist devices (LVADs) continues to present treatment challenges. Anti-coagulation strategies used to treat this complication are empiric and without firm data for guidance. The addition of a platelet glycoprotein IIb/IIIa inhibitor to intravenous anti-coagulation has been suggested by several case series and recent guidelines. The aim of this study was to evaluate our use of eptifibatide for the treatment of suspected pump thrombus/thrombosis. Methods: This retrospective, single-center cohort study was performed at Barnes-Jewish Hospital. The medical informatics system was queried to identify all LVAD patients who received eptifibatide for suspected pump thrombus/thrombosis from January 1, 2011, through April 30, 2013. Results: A total of 17 patients (16 HeartMate II [Thoratec, Pleasanton, CA], 1 HeartWare [HeartWare International Inc, Framingham, MA]) with 22 separate administration attempts received eptifibatide (dose range, 0.1–2 μg/kg/min) for suspected pump thrombus/thrombosis presenting as one or more of the following findings: elevated lactate dehydrogenase, decreased haptoglobin, elevated plasma free hemoglobin, LVAD dysfunction, or new, persistently high LVAD power. The mean time from device implantation to eptifibatide therapy was 47.34 days (range, 3.88–397.67 days). Of the 22 attempts, 5 (22.7%) resulted in resolution of 1 or more patient-specific indicators of LVAD thrombus/thrombosis. Three patients (17.6%) had resolution of an indicator while also remaining free from continued hemolysis, death, pump exchange, or emergent heart transplant. Bleeding events were common, with 11 patients (64.7%) experiencing bleeding during the infusion. Seven patients (41.2%) died, with intraparenchymal hemorrhage as the cause of death in 2 patients. Pump exchange was performed in 3 patients. Conclusions: Our limited experience indicates the risk of using eptifibatide outweighs the proposed benefit of salvaging the existing LVAD in the setting of suspected pump thrombus/thrombosis at our institution. [Copyright &y& Elsevier]

Background: Hemolysis is becoming increasingly recognized as a major complication of left ventricular assist device (LVAD) support. Data regarding risk factors, prevalence, and outcomes are limited. To better define the characteristics and prognosis of hemolysis, we present a retrospective case-control study of LVAD patients in our institution. Methods: A detailed record review was conducted of 18 patients supported with the HeartMate II (HMII; Thoratec Corp, Pleasanton, CA) who were diagnosed with hemolysis, and their data were compared with 82 patients who received an LVAD implant during the same period who did not develop hemolysis. Patients were excluded if they did not survive hospitalization at the time of LVAD implantation. The primary end points of this analysis were time to death and time to first hospitalization. Results: Of 100 total patients, 18 HMII patients (18%) were diagnosed with hemolysis. Those with hemolysis were younger, had significantly higher lactate dehydrogenase and bilirubin levels, lower international normalized ratio, and no difference in cannula velocities by transthoracic echocardiography. Patient survival in the hemolysis group was markedly decreased at 1 year (38.9% vs 89.3%, p < 0.001), but no differences in hospitalization (p = 0.57) were observed. Partial to complete thrombosis was noted in all of the pumps at explant. Conclusions: These findings demonstrate that hemolysis is associated with high mortality, likely serving as a marker of pump thrombosis. Elevated lactate dehydrogenase and bilirubin levels are important indicators for hemolysis, and lower international normalized ratio may pre-dispose for this worrisome condition. Diagnosis should prompt clinicians to consider pump exchange or explant, listing for transplantation, or intensifying anti-coagulation. [Copyright &y& Elsevier]

Background: Pump thrombosis remains an uncommon but potentially catastrophic complication of durable continuous-flow left ventricular assist devices (LVAD). A perceived increase in the incidence of pump thrombosis in the HeartMate II (HMII) LVAD (Thoratec, Pleasanton, CA) by clinicians prompted this analysis of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database. Methods: Between 2006 and June 2013, 8,988 United States patients aged older than 18 years received a durable LVAD. Of these, 6,910 adult patients from 132 institutions who received a HMII LVAD were entered in the INTERMACS database and constitute the study group for this analysis. Results: Overall survival (with censoring at transplant or explant for recovery) with the HMII LVAD was 80% at 1 year and 69% at 2 years and was not significantly different when stratified by era of implant. Freedom from device exchange or death due to thrombosis decreased from 99% at 6 months in 2009 to 94% in 2012 (p < 0.0001). Multivariable hazard function analysis showed risk factors for pump thrombosis included later implant year (p < 0.0001), younger age (p < 0.0001), higher creatinine (p = 0.002), larger body mass index (p = 0.004), white race (p = 0.0004), left ventricular ejection fraction above 20% (p = 0.02), and higher lactate dehydrogenase level at 1 month (p < 0.0001). Survival (p < 0.0001) and freedom from infection (p = 0.008) and cerebrovascular accident (p < 0.0001) were lower after pump exchange than after primary implant. Conclusions: Pump exchange or death due to pump thrombosis increased during 2011 and 2012, but the magnitude of the increase remained relatively small. Survival remains high (80% at 1 year) with the HMII LVAD. Risk factor analysis suggests that a number of patient-related factors contribute to the risk of thrombosis. Markedly elevated lactate dehydrogenase in the first month is a predictor of pump thrombosis. This analysis could not examine the potential role of technical factors during implant, such as sub-optimal pump or graft positioning, changes in patient management paradigms with pump speed settings, improved recognition and change in the threshold for pump exchange, or design or production changes with the pump, as contributors to the risk of pump thrombosis. [Copyright &y& Elsevier]

Pump thrombosis is a dreaded complication of long-term implantable ventricular assist devices. No guidance exists regarding the diagnosis and management of this entity despite its significant morbidity. After considerable thought and deliberation, a group of leading investigators in the field of mechanical support propose an algorithm for the diagnosis and management of this vexing entity based on clinical symptoms and serologic and imaging studies. [ABSTRACT FROM AUTHOR]