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Thoracoabdominal normothermic regional perfusion (TA-NRP) has emerged as a powerful technique for optimizing organ procurement from donation after circulatory death donors. Despite its rapid adoption, standardized guidelines for TA-NRP implementation are lacking, prompting the need for consensus recommendations to ensure safe and effective utilization of this technique. A working group composed of members from The American Society of Transplant Surgeons, The International Society of Heart and Lung Transplantation, The Society of Thoracic Surgeons, and The American Association for Thoracic Surgery was convened to develop technical guidelines for TA-NRP. The group systematically reviewed existing literature, consensus statements, and expert opinions to identify key areas requiring standardization, including predonation evaluation, intraoperative management, postdonation procedures, and future research directions. The working group formulated recommendations encompassing donor evaluation and selection criteria, premortem testing and therapeutic interventions, communication protocols, and procedural guidelines for TA-NRP implementation. These recommendations aim to facilitate coordination among transplant teams, minimize variability in practice, and promote transparency and accountability throughout the TA-NRP process. The consensus guidelines presented herein serve as a comprehensive framework for the successful and ethical implementation of TA-NRP programs in organ procurement from donation after circulatory death donors. By providing standardized recommendations and addressing areas of uncertainty, these guidelines aim to enhance the quality, safety, and efficiency of TA-NRP procedures, ultimately contributing to improved outcomes for transplant recipients. [ABSTRACT FROM AUTHOR]

Background: As left ventricular assist device (LVAD) survival rates continue to improve, evaluating site-specific variability in outcomes can facilitate identifying targets for quality-improvement initiative opportunities in the field.Methods: Deidentified center-specific outcomes were analyzed for HeartMate 3 (HM3) patients enrolled in the MOMENTUM 3 pivotal and continued access protocol trials. Centers < 25th percentile for HM3 volumes were excluded. Variability in risk-adjusted center mortality was assessed at 90 days and 2 years (conditional upon 90-day survival). Adverse event (AE) rates were compared across centers.Results: In the 48 included centers (1958 patients), study-implant volumes ranged between 17 and 106 HM3s. Despite similar trial-inclusion criteria, patient demographics varied across sites, including age quartile ((Q)1-Q3:57-62 years), sex (73%-85% male), destination therapy intent (60%-84%), and INTERMACS profile 1-2 (16%-48%). Center mortality was highly variable, nadiring at ≤ 3.6% (≤ 25th percentile) and peaking at ≥ 10.4% (≥ 75th percentile) at 90 days and ≤ 10.2% and ≥ 18.7%, respectively, at 2 years. Centers with low mortality rates tended to have lower 2-year AE rates, but no center was a top performer for all AEs studied.Conclusions: Mortality and AEs were highly variable across MOMENTUM 3 centers. Studies are needed to improve our understanding of the drivers of outcome variability and to ascertain best practices associated with high-performing centers across the continuum of intraoperative to chronic stages of LVAD support. [ABSTRACT FROM AUTHOR]

Background This study investigates the impact of left ventricular assist device (LVAD) inflow cannula angulation, pump positional change over time, and the incidence of thrombotic pump dysfunction in a large cohort of HeartMate II (HM2) patients. Methods Patients (n = 326) who received primary HM2 LVAD between January 2008 and December 2013 at a single institution were retrospectively reviewed. Patients who underwent pump exchange (PE) for pump dysfunction, patients who had pump dysfunction (PD) but did not require pump exchange, and patients with normal LVAD pump dysfunction (NL) were compared. Pump positional change and angle of the inflow cannula with respect to the angle between inflow cannula and the LVAD body (IL angle) were measured from routine chest radiograph at postoperation, before discharge, and follow-up. Pump positional change was assessed based on pump positional differences between discharge and follow-up. Patients were also grouped by IL acute angulation (less than 65 degrees) and pump positional change. Results There were 21, 15, and 290 patients in the PE group, PD group, and NL group, respectively. There were significant differences in IL angle between PE and NL at all timepoints: postoperation (PD 63.6 ± 12.5, NL 70.6 ± 12.3; p = 0.018), before discharge (PD 64.4 ± 12.8, NL 69.5 ± 10.5; p = 0.039), and follow-up (PD 62.6 ± 14.2, NL 67.9 ± 11.2; p = 0.002). However, the IL angle was insignificant between PE and PD groups and between PD and NL groups. Sixty-seven percent of the PE group had pump positional change as opposed to 36% of the NL group ( p = 0.019). Eighty-four of 101 patients with pump positional change and 75 of 91 patients with acute angulation at postoperation did not have pump dysfunction. Conclusions Pump positional change may contribute to LVAD dysfunction or failure, but it does not entirely account for observed pump dysfunction or failure. [ABSTRACT FROM AUTHOR]

Background Biventricular support before orthotopic heart transplantation (OHT) has been shown to adversely affect short- and long-term outcomes, but the comparative effect of support type is largely unknown. This study determined the comparative effect of univentricular and biventricular support on survival in bridged patients after OHT. Methods The United Network of Organ Sharing database was queried for adult patients bridged to OHT with a univentricular (left ventricular assist device [LVAD]), biventricular (biventricular assist device [BiVAD]), or total artificial heart ([TAH]) device between 2004 and 2012. Unconditional and conditional survivals were compared with the Kaplan-Meier method. Cox proportional hazards regression models were constructed to determine the risk-adjusted influence of support type on death. Results Of the 4,177 patients identified, 3,457 (20.4%), 575 (3.4%), and 145 (0.9%) were bridged with an LVAD, BiVAD, and TAH, respectively. Unadjusted 30-day, 1-year, and 5-year estimated survival was greater in LVAD patients than in the BiVAD and TAH cohorts. After risk-adjustment, BiVAD and TAH were associated with an increased risk of death at all time points. Unadjusted and adjusted 5-year survival, conditional on 1-year survival, was worse, however, in only TAH patients. Conclusions Patients with biventricular failure bridged to OHT with a TAH or BiVAD experience worse short- and long-term survival comparison with those with an LVAD. This difference is most likely due to an increase in early death and depends on the type of BiVAD device implanted. [ABSTRACT FROM AUTHOR]

Objective: The aim of this work was to characterize the clinical response and identify predictors of clinical stabilization after intra-aortic balloon counterpulsation (IABP) support in patients with chronic systolic heart failure in cardiogenic shock before implantation of a left ventricular assist device (LVAD).Background: Limited data exist regarding the clinical response to IABP in patients with chronic heart failure in cardiogenic shock.Methods: We identified 54 patients supported with IABP before LVAD implantation. Criteria for clinical decompensation after IABP insertion and before LVAD included the need for more advanced temporary support, initiation of mechanical ventilation or dialysis, increase in vasopressors/inotropes, refractory ventricular arrhythmias, or worsening acidosis. The absence of these indicated stabilization.Results: Clinical decompensation after IABP occurred in 23 patients (43%). Both patients who decompensated and those who stabilized had similar hemodynamic improvements after IABP support, but patients who decompensated required more vasopressors/inotropes. Clinical decompensation after IABP was associated with worse outcomes after LVAD implantation, including a 3-fold longer intensive care unit stay and 5-fold longer time on mechanical ventilation (P < .01 for both). Although baseline characteristics were similar between groups, right and left ventricular cardiac power indexes (cardiac power index = cardiac index × mean arterial pressure/451) identified patients who were likely to stabilize (area under the receiver operating characteristic curve = 0.82).Conclusions: Among patients with chronic systolic heart failure who develop cardiogenic shock, more than one-half of patients stabilized with IABP support as a bridge to LVAD. Baseline measures of right and left ventricular cardiac power, reflecting work performed for a given flow and pressure, may allow clinicians to identify patients with sufficient contractile reserve who will be likely to stabilize with an IABP versus those who may need more aggressive ventricular support. [ABSTRACT FROM AUTHOR]

The decreasing size in continuous flow left ventricular assist devices has facilitated alternative approaches to implantation with nonsternotomy approaches increasing in adaptation over the last 5 years. Preserving the sternum for easier reoperation at cardiac transplant, decreasing the necessary dissection, and preservation of right ventricular function are potential benefits of such techniques. Most operative approaches use a left thoracotomy to access the left ventricular apex for inflow placement and variably combine an upper sternotomy or right thoracotomy with standard aortic graft placement. In patients with alternative outflow sites, most of the operation is performed through a left thoracotomy incision. With these approaches, the need for cardiopulmonary bypass is assessed with many operators avoiding its use for left ventricular assist device implantation. Additional potential benefits included decreased transfusion and shorter operative times, which may facilitate earlier hospital discharge. [ABSTRACT FROM AUTHOR]

Objective: To assess the effect of extremity vascular complications (EVCs, including ischemia or vessel trauma) on the outcomes of patients receiving cardiac support devices (CSDs, including ventricular assist device [VAD] and extracorporeal membrane oxygenation [ECMO]). Methods: Institutional Review Board-approved, retrospective review of a prospectively maintained database of all temporary and permanent CSD recipients from 7/1/10 to 6/30/12. Patient demographics, procedural data, and outcomes were analyzed. The primary endpoint was all-cause mortality at 30-days post-CSD initiation. Results: Of 208 patients who received CSDs, 31 (14.9%) experienced EVC: 13 (8.9%) of the 146 permanent VADs, 10 (26.3%) of the 38 temporary VADs, and 8 (33.3%) of the 24 ECMO patients. The 30-day mortality for CSD-EVC patients was not significantly higher than that of the CSD patients who did not experience EVC for permanent VAD (15.4% vs 4.5%; P = .15) and ECMO patients (50.0% vs 68.75%; P = 1.00), but was significantly higher for temporary VAD patients (80.0% vs 35.7%; P = .03). Within the CSD-EVC cohort, patients who received a temporary VAD had a significantly higher 30-day mortality and decision to withdraw care after EVC compared with those who received a permanent VAD (P = .01 and P < .01, respectively). Looking beyond the 30-day window, EVC was associated with higher mortality rates in the permanent VAD population (53.8% vs 25.6%; P = .025) but not the temporary VAD or ECMO groups. Conclusions: In temporary VAD recipients, EVCs result in higher 30-day mortality, more frequent withdrawal of care, and shortened survival time relative to the global temporary VAD group. EVC in permanent VAD recipients did not affect early (30-day) mortality rates, but strongly predicted a higher cumulative mortality risk for the 2-year study period. Overall ECMO mortality rates were high, and not significantly impacted by the occurrence of EVC. The nature of the EVC (cannulation site complication vs embolic injury) did not impact mortality. This data provides quality improvement targets for VAD programs. [Copyright &y& Elsevier]

Background: The purpose of this study is to comparatively analyze outcomes of heart transplant patients bridged to transplantation with HeartWare (HW-VAD) versus HeartMate II (HMII-VAD) left ventricular assist devices. Methods: The United Network for Organ Sharing Database was reviewed to identify first-time heart transplant recipients who were bridged to transplantation with either HW-VAD (n = 141) or HMII-VAD (n = 1824) from January 2009 through July 2012. Results: Recipients of HW-VAD had a higher proportion of female patients (27.0% versus 18.9%; p = 0.019), a lower body surface area (2.01 ± 0.25 m2 versus 2.06 ± 0.25 m2; p = 0.035), and a trend toward a higher peak percentage of panel reactive antibody against human leukocyte class I antigens (40.4% ± 32.8% versus 33.0% ± 30.4%; p = 0.070). Pretransplantation recipient cardiac index (2.33 ± 0.66 L ⋅ min−1 ⋅ m−2 versus 2.33 ± 0.68 L ⋅ min−1 ⋅ m−2), serum creatinine (1.21 ± 0.43 mg/dL versus 1.26 ± 0.57 mg/dL), and total bilirubin (1.34 ± 3.45 mg/dL versus 1.06 ± 1.84 mg/dL) were comparable between the two groups (p > 0.05 for all comparisons). After transplantation, there were no significant differences in freedom from rejection or freedom from cardiac allograft vasculopathy. Posttransplant graft survival rates were similar between the HW-VAD group and the HMII-VAD group at 1, 2, and 3 years (88.4% versus 87.8%, 79.9% versus 83.8%, and 77.4% versus 79.9%, respectively; p = 0.843). Conclusions: These findings suggest similar hemodynamic unloading, pretransplant end-organ function, and posttransplant outcomes in patients bridged to transplantation with both the HW-VAD and HMII-VAD. [Copyright &y& Elsevier]

Background: Although several studies have examined factors affecting survival after orthotopic heart transplantation (OHT), few have evaluated the impact of reoperative sternotomy. We undertook this study to examine the incidence and impact of repeat sternotomies on OHT outcomes. Methods: We conducted a retrospective review of all adult OHT from 2 institutions. Primary stratification was by the number of prior sternotomies. The primary outcome was survival. Secondary outcomes included blood product utilization and commonly encountered postoperative complications. Multivariable Cox proportional hazards regression models examined mortality while linear regression models examined blood utilization. Results: From January 1995 to October 2011, 631 OHT were performed. Of these, 25 (4.0%) were redo OHT and 182 (28.8%) were bridged to transplant with a ventricular assist device; 356 (56.4%) had undergone at least 1 prior sternotomy. On unadjusted analysis, reoperative sternotomy was associated with decreased 90-day (98.5% vs 90.2%, p < 0.001), 1-year (93.1% vs 79.6%, p < 0.001), and 5-year (80.4% vs 70.1%, p = 0.002) survival. This difference persisted on multivariable analysis at 90 days (hazard ratio [HR] 2.99, p = 0.01), 1 year (HR 2.98, p = 0.002), and 5 years (HR 1.62, p = 0.049). The impact of an increasing number of prior sternotomies was negligible. On multivariable analysis, an increasing number of prior sternotomies was associated with increased intraoperative blood product utilization. Increasing blood utilization was associated with decreased 90-day, 1-year, and 5-year survival. Conclusions: Reoperative sternotomy is associated with increased mortality and blood utilization after OHT. Patients with more than 1 prior sternotomy do not experience additional increased mortality. Carefully selected patients with multiple prior sternotomies have decreased but acceptable outcomes. [ABSTRACT FROM AUTHOR]

Objective: Preoperative use of clopidogrel increases the risk of bleeding, but its postoperative use has not been studied. We studied early postoperative clopidogrel use in on-pump and off-pump coronary artery bypass grafting. Methods: Data were obtained from the University HealthSystem Consortium database. We conducted a retrospective analysis of data of 15,067 adults who had coronary artery bypass grafting between 2003 and 2006 and received perioperative aspirin alone or in combination with clopidogrel, with the latter administered within 2 days after coronary artery bypass grafting. Logistic regression was used to analyze in-hospital mortality, 30-day readmission, ischemic or thrombotic events, and bleeding events, with propensity score adjustment for clopidogrel treatment. Results: Combined aspirin and clopidogrel were used in 3268 patients (22%). Compared with aspirin alone, aspirin plus clopidogrel was associated with reductions of in-hospital mortality (0.95% vs 1.78%; adjusted odds ratio: 0.50; 95% confidence interval: 0.25, 0.99) and bleeding events (4.19% vs 5.17%; adjusted odds ratio: 0.70; 95% confidence interval: 0.51, 0.97). Ischemic or thrombotic events were not significantly different (1.29% vs 1.53%; adjusted odds ratio, 0.99; 95% confidence interval: 0.59, 1.64). The relative effect of combined treatment did not differ between on-pump and off-pump coronary artery bypass grafting. Conclusions: Early postoperative clopidogrel combined with aspirin may be safe and beneficial compared with perioperative aspirin treatment alone, in both on-pump and off-pump coronary artery bypass grafting. However, a possibility of selection bias calls for randomized controlled trials to confirm our findings. [Copyright &y& Elsevier]

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 Management of existing mitral valve (MV) disease in patients undergoing left ventricular assist device (LVAD) implantation remains controversial. Methods Among continuous-flow LVAD patients with moderate to severe mitral regurgitation entered into the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database between April 2008 and March 2014 ( n = 4,930), outcomes were compared between patients who underwent MV repair (MVr, n = 252), MV replacement (MVR, n = 11) and no MV procedure (no MVP, n = 4,667). Impact on survival was analyzed by stratified actuarial and hazard function multivariable methodology. Post-operative functional capacity and quality of life were assessed. Results Patients who underwent MVPs had higher pre-operative pulmonary vascular resistance (3.6 ± 2.9 vs 2.9 ± 2.6 Wood units; p = 0.0006) and higher pulmonary artery systolic pressures (55.1 ± 13.8 vs 51.5 ± 14.0 mm Hg; p = 0.0003). Two-year survival was 76% for patients with concomitant MVr, 57% for those with MVR and 71% for those with no MVP ( p = 0.15). By multivariable analysis, neither MVr nor MVR affected early or late survival. Although improvements in post-operative functional status as evaluated by 6-minute walk distances were comparable across groups, visual analog score assessments of quality of life suggested a benefit of concomitant MVPs at 1-year post-implant (79.00 ± 1.73 vs 74.45 ± 0.51; p = 0.03), with fewer re-admissions observed for MVP patients ( p < 0.0001). Conclusions Concomitant MVPs are not associated with increased survival overall. However, MVPs are associated with benefits in terms of reduced hospital re-admission and improved quality of life in select patients. [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 Stroke is a significant complication in patients supported with continuous-flow left ventricular assist devices (CF-LVAD) and hypertension is a significant risk factor for stroke, but the association between blood pressure and stroke in LVAD patients is not well characterized. Methods We identified 275 consecutive patients who survived implant hospitalization between January 2005 and April 2013. Patients were grouped according to systolic blood pressure (SBP) as above a median and below a median of 100 mm Hg by their averaged systolic blood pressure during the 48 hours before discharge from implantation hospitalization. The groups were compared for the primary outcome of time to stroke. Results The above-median SBP group had mean SBP of 110 mm Hg and the below-median SBP group had mean SBP of 95 mm Hg. There were no significant between-group differences in body mass index, smoking, vascular disease, hypertension, atrial fibrillation, or prior stroke. During a mean follow-up of 16 months, stroke occurred in 16% of the above-median SBP group vs in 7% of the below-median SBP group (hazard ratio, 2.38; 95% confidence interval, 1.11–5.11), with a similar proportion of hemorrhagic and ischemic strokes in each group. In Cox proportional hazard models adjusting for age, diabetes, or prior stroke, the hazard ratio remained statistically significant. SBP as a continuous variable predictor of stroke had an area under the curve of 0.64 in a receiver operating characteristic curve analysis. Conclusions In this large, CF-LVAD cohort, elevated SBP was independently associated with a greater risk of subsequent stroke. These results identify management of hypertension as a potential modifiable risk factor for reducing the incidence of stroke in patients supported by CF-LVAD. [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]

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: 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]