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Background: Patients receiving left ventricular assist device (LVAD) support require long-term anticoagulation to reduce the risk of thromboembolic complications. Apixaban is a direct oral anticoagulant that has become first-line therapy; however, its safety in LVAD recipients has not been well described., Objectives: This study sought to investigate whether, in patients with a fully magnetically levitated LVAD, treatment with apixaban would be feasible and comparable with respect to safety and freedom from the primary composite outcome of death or major hemocompatibility-related adverse events (HRAEs) (stroke, device thrombosis, major bleeding, aortic root thrombus, and arterial non-central nervous system thromboembolism) as compared with treatment with warfarin., Methods: The DOAC LVAD (Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices) trial was a phase 2, open label trial of LVAD recipients randomized 1:1 to either apixaban 5 mg twice daily or warfarin therapy. All patients were required to take low-dose aspirin. Patients were followed up for 24 weeks to evaluate the primary composite outcome., Results: A total of 30 patients were randomized: 14 patients to warfarin and 16 patients to apixaban. The median patient age was 60 years (Q1-Q3: 52-71 years), and 47% were Black patients. The median time from LVAD implantation to randomization was 115 days (Q1-Q3: 56-859 days). At 24 weeks, the primary composite outcome occurred in no patients receiving apixaban and in 2 patients (14%) receiving warfarin (P = 0.12); these 2 patients experienced major bleeding from gastrointestinal sources., Conclusions: Anticoagulation with apixaban was feasible in patients with an LVAD without an excess of HRAEs or deaths. This study informs future pivotal clinical trials evaluating the safety and efficacy of apixaban in LVAD recipients. (Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices [DOAC LVAD]; NCT04865978)., Competing Interests: Funding Support and Author Disclosures This study was sponsored by Inova Health System and funded by Abbott. Dr P. Shah has received grant support unrelated to this work and paid to Inova from Merck, Bayer, and Roche; and has served as a consultant for Natera, Merck, Ortho Clinical Diagnostics, and Procyrion. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Implantable left ventricular assist device (LVAD) therapy is used to improve quality of life, alleviate symptoms and extend survival rates in patients with advanced heart failure. Patients with LVADs require chronic anticoagulation to reduce the risk of thromboembolic complications, and they commonly experience bleeding events. Apixaban is a direct oral anticoagulant that has become first-line therapy for patients with nonvalvular atrial fibrillation and venous thromboembolism; however, its safety in patients with LVADs has not been well characterized. The evaluation of the hemocompatibility in the DOAC LVAD (Direct Oral Anti-Coagulant apixaban in Left Ventricular Assist Devices) trial is a phase 2, open-label trial of patients with LVADs who were randomized to either apixaban or warfarin therapy. Patients randomized to apixaban will be started on a dosage of 5 mg twice daily, whereas those randomized to warfarin will be managed at an International Normalized Ratio goal of 2.0-2.5. All patients will be treated with aspirin at 81 mg daily. We plan to randomize and follow as many as 40 patients for 24 weeks to evaluate the primary outcomes of freedom from death or hemocompatibility-related adverse events (stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism). The DOAC LVAD trial will establish the feasibility of apixaban anticoagulant therapy in patients with LVADs. Clinicaltrials.gov: NCT04865978., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: The benefits of standardized care for cardiogenic shock (CS) across regional care networks are poorly understood., Objectives: The authors compared the management and outcomes of CS patients initially presenting to hub versus spoke hospitals within a regional care network., Methods: The authors stratified consecutive patients enrolled in their CS registry (January 2017 to December 2019) by presentation to a spoke versus the hub hospital. The primary endpoint was 30-day mortality. Secondary endpoints included bleeding, stroke, or major adverse cardiovascular and cerebrovascular events., Results: Of 520 CS patients, 286 (55%) initially presented to 34 spoke hospitals. No difference in mean age (62 years vs 61 years; P = 0.38), sex (25% vs 32% women; P = 0.10), and race (54% vs 52% white; P = 0.82) between spoke and hub patients was noted. Spoke patients more often presented with acute myocardial infarction (50% vs 32%; P < 0.01), received vasopressors (74% vs 66%; P = 0.04), and intra-aortic balloon pumps (88% vs 37%; P < 0.01). Hub patients were more often supported with percutaneous ventricular assist devices (44% vs 11%; P < 0.01) and veno-arterial extracorporeal membrane oxygenation (13% vs 0%; P < 0.01). Initial presentation to a spoke was not associated with increased risk-adjusted 30-day mortality (adjusted OR: 0.87 [95% CI: 0.49-1.55]; P = 0.64), bleeding (adjusted OR: 0.89 [95% CI: 0.49-1.62]; P = 0.70), stroke (adjusted OR: 0.74 [95% CI: 0.31-1.75]; P = 0.49), or major adverse cardiovascular and cerebrovascular events (adjusted OR 0.83 [95% CI: 0.50-1.35]; P = 0.44)., Conclusions: Spoke and hub patients experienced similar short-term outcomes within a regionalized CS network. The optimal strategy to promote standardized care and improved outcomes across regional CS networks merits further investigation., Competing Interests: Funding Support and Author Disclosures Dr Tehrani has served on the advisory board for Abbott; has received research grants from Boston Scientific and Inari Medical; and has served as a consultant for Boston Scientific. Dr Truesdell has served as a consultant for Abiomed. Dr Ibrahim has received honoraria from Medtronic. Dr Shah is supported by a National Institutes of Health K23 Career Development Award 1K23HL143179; has served as a consultant for Merck, Novartis, and Procyrion; and his institution has received grant support from Abbott, Roche, Merck and Bayer for unrelated research. Dr Batchelor has served as consultant for Boston Scientific, Abbott, Medtronic, and V-Wave. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Despite improvements in pump design and durability, left ventricular assist device patients still suffer from life-threatening complications such as pump thrombosis (PT) and infection, often necessitating device exchange. Surgical exchange from HeartMate II (HM2; Abbott, Pleasanton, CA) to another HM2 is safe and associated with low mortality, but recurrent device thrombosis rates are high. Switching from axial-flow to centrifugal-flow pump, such as the HeartWare ventricular assist device (HVAD; Medtronic, Framingham, MA) may offer certain advantages due to it being a smaller, newer generation device, although there are limited data to support this strategy. Herein, we aimed to assess the surgical approach and feasibility, safety, and outcomes of surgical exchange from HM2 to HVAD., Methods: We evaluated HM2 patients who underwent device exchange to HVAD due to PT or infection at 4 large-volume left ventricular assist device implant centers., Results: Twenty-four patients underwent HM2 to HVAD exchange due to PT (92%) and refractory infection (8%). Patients were male (75%), white (88%), with ischemic cardiomyopathy (54%), Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) scale level 1-3 (90%), and destination therapy (62%). The majority underwent redo-sternotomy (79%) and the remainder underwent minimally invasive thoracotomy with subcostal approach. The existing HM2 outflow graft was maintained in 79% of cases. Recurrent PT was noted in 9% of patients. Mortality was 8% at 30 days and 33% at 1 year., Conclusions: The surgical exchange from a HM2 to HVAD is safe and feasible, despite the differences in device specifications and surgical adaptation required. Newer-generation pumps are increasingly considered for exchange in the setting of HM2 device complication, and increasing experience with modified surgical approaches may be valuable in the current era., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Right ventricular failure (RVF) portends poor outcomes after left ventricular assist device (LVAD) implantation. Although numerous RVF predictive models have been developed, there are few independent comparative analyses of these risk models., Methods and Results: RVF was defined as use of inotropes for >14 days, inhaled pulmonary vasodilators for >48 hours or unplanned right ventricular mechanical support postoperatively during the index hospitalization. Risk models were evaluated for the primary outcome of RVF by means of logistic regression and receiver operating characteristic curves. Among 93 LVAD patients with complete data from 2011 to 2016, the Michigan RVF score (C = 0.74 [95% CI 0.61-0.87]; P = .0004) was the only risk model to demonstrate significant discrimination for RVF, compared with newer risk scores (Utah, Pitt, EuroMACS). Among individual hemodynamic/echocardiographic metrics, preoperative right ventricular dysfunction (C = 0.72 [95% CI 0.58-0.85]; P = .0022) also demonstrated significant discrimination of RVF. The Michigan RVF score was also the best predictor of in-hospital mortality (C = 0.67 [95% CI 0.52-0.83]; P = .0319) and 3-year survival (Kaplan-Meier log-rank 0.0135)., Conclusions: In external validation analysis, the more established Michigan RVF score-which emphasizes preoperative hemodynamic instability and target end-organ dysfunction-performed best, albeit modestly, in predicting RVF and demonstrated association with in-hospital and long-term mortality., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: The objective of this work was to determine the impact of improving right ventricular versus left ventricular stroke work indexes (RVSWI vs LVSWI) during therapy for acute decompensated heart failure (ADHF)., Methods and Results: Cox proportional hazards regression and logistic regression were used to analyze key factors associated with outcomes in 175 patients (mean age 56.7 ± 13.6 years, 29.1% female) with hemodynamic data from the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness trial. In this cohort, 28.6% and 69.7%, respectively, experienced the outcomes of death, transplantation, or ventricular assist device implantatation (DVADTX) and DVADTX or HF rehospitalization (DVADTXHF) during 6 months of follow-up. Increasing RVSWI (ΔRVSWI) from baseline to discharge was associated with a decrease in DVADTXHF (hazard ratio [HR] 0.923, 95% confidence interval [CI] 0.871-0.979) per 0.1 mm Hg⋅L⋅m -2 increase); however, increasing LVSWI (ΔLVSWI) had only a nonsignificant association with decreased DVADTXHF (P = .11) In a multivariable model, patients with ΔRVSWI ≤1.07 mm Hg⋅L⋅m -2 and ΔLVSWI ≤4.57 mm Hg⋅L⋅m -2 had a >2-fold risk of DVADTXHF (HR 2.05, 95% CI 1.23-3.41; P = .006)., Conclusion: Compared with left ventricular stroke work, increasing right ventricular stroke work during treatment of ADHF was associated with better outcomes. The results promise to inform optimal hemodynamic targets for ADHF., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background & Aims: The risk of gastrointestinal (GI) bleeding (GIB) and thromboembolic events may increase with continuous-flow left ventricular assist devices (CF-LVADs). We aimed to characterize GIB and thromboembolic events that occurred in patients with CF-LVADs and compare them with patients receiving anticoagulation therapy., Methods: We performed a retrospective analysis of 159 patients who underwent CF-LVAD placement at 2 large academic medical centers (mean age, 55 ± 13 y). We identified and characterized episodes of GIB and thromboembolic events through chart review; data were collected from a time period of 292 ± 281 days. We compared the rates of GIB and thromboembolic events between patients who underwent CF-LVAD placement and a control group of 159 patients (mean age, 64 ± 15 y) who received a cardiac valve replacement and were discharged with anticoagulation therapy., Results: Bleeding events occurred in 29 patients on CF-LVAD support (18%; 45 events total). Sixteen rebleeding events were identified among 10 patients (range, 1-3 rebleeding episodes/patient). There were 34 thrombotic events among 27 patients (17%). The most common source of bleeding was GI angiodysplastic lesions (n = 20; 44%). GIB and thromboembolic events were more common in patients on CF-LVAD support than controls; these included initial GIB (18% vs 4%, P < .001), rebleeding (6% vs none, P = .001), and thromboembolic events (17% vs 8%, P = .01)., Conclusions: Patients with CF-LVADS receiving anticoagulants have a significantly higher risk of GIB and thromboembolic events than patients receiving anticoagulants after cardiac valve replacement surgery. GI angiodysplastic lesions are the most common source of bleeding., (Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Objective: Several strategies have been used to reduce the incidence of right ventricular failure after left ventricular assist device (LVAD) placement, including pulmonary vasodilation. The inhaled prostacyclin, epoprostenol, selectively dilates the pulmonary vasculature of ventilated areas of the lung, but also has been shown to inhibit platelet aggregation.(1) The authors evaluated the impact of early initiation of epoprostenol administration during LVAD placement on pulmonary artery pressures, use of vasoactive drugs, and blood loss., Design: Retrospective data review., Setting: Single center, university hospital., Participants: A total of 37 consecutive patients undergoing LVAD (HeartMate II) placement were included., Interventions: In the first group of 23 patients (group 1), inhaled epoprostenol was not initiated until weaning from cardiopulmonary bypass (CPB). In a subsequent group of 14 patients (group 2), inhaled epoprostenol was started shortly after induction of anesthesia and continued throughout and post-CPB., Measurements: Mean and systolic pulmonary artery pressures (mPAP, sPAP), vasoactive drugs, as well as hemodynamic parameters, blood loss, and use of blood products were recorded at the following time points: Baseline (BL), pre-CPB, post-CPB, and during postoperative days (POD) 0, 1, and 2. Data are presented as mean±SD or median [25%, 75%]., Results: Groups did not differ in demographic characteristics and comorbidities. BL sPAP (41±13 v 46±15 mmHg; p = 0.051) and mPAP (32±8 v 34±8 mmHg; p = 0.483) values were not different between the groups. Systolic and mPAP in group 1 were significantly lower in the postoperative period compared with BL (sPAP on POD 0: 34±6 mmHg; p<0.001; mPAP on POD 0, 1, and 2: 24±4 mmHg, 25±4 mmHg, 27±6 mmHg; p<0.001-0.003)). In contrast, in group 2, sPAP as well as mPAP were significantly lower during weaning from CPB (sPAP: 37±8; p = 0.002; mPAP: 28±5 mmHg; p = 0.016) as well as in the postoperative period (sPAP on POD 0, 1 and 2: 34±7, 35±7, and 37±10 mmHg; p<0.001-0.004; mPAP on POD 0, 1, and 2: 24±4 mmHg, 25±5 mmHg, 27±6 mmHg; p<0.001-0.006). Blood loss on postoperative day 0 was significantly lower in group 1 (1646 mL [1137, 2300] v 2915 mL [2335, 6155]; p = 0.006). Epoprostenol was a significant predictor of blood loss in the regression model (p<0.001) but did not predict a change in sPAP., Conclusions: Inhaled prostacyclin reduces sPAP and mPAP in the postoperative period after LVAD placement regardless of the timing of initiation. Early initiation seems to reduce sPAP as well as mPAP more effectively during the weaning process from CPB. However, early initiation is associated with an increased blood loss in the immediate postoperative period. The concept of preventively "bathing" the lung in prostacyclin should be evaluated critically in a prospective fashion to adequately examine this question., (Copyright © 2014 Elsevier Inc. All rights reserved.)

We report the first documented case of HeartMate II® left ventricular assist device (LVAD) reimplantation following Cohn Teflon felt plug repair of the initial left ventricular apical cannulation site. This case highlights the current limitations of the predictability of myocardial recovery while describing an effective technique for possible future LVAD reimplantation., (© 2012 Wiley Periodicals, Inc.)

Late stages of hypertrophic cardiomyopathy (HCM) result in medically refractory heart failure. Current treatments include septal myomectomy or alcohol ablation; however, not all patients are eligible for these procedures. We describe the technical aspects of implantation of a HeartMate II left ventricular assist device as a bridge to transplant therapy for a patient with HCM and end-stage heart failure. Pre- and post-operative imaging demonstrates the importance of establishing a functional inflow tract for the device., (© 2011 Wiley Periodicals, Inc.)