Durable Mechanical Circulatory Support Devices Research Articles

Stroke and Mechanical Circulatory Support in Adults.

Short-term and durable mechanical circulatory support (MCS) devices represent life-saving interventions for patients with cardiogenic shock and end-stage heart failure. This review will cover the epidemiology, risk factors, and treatment of stroke in this patient population. Short-term devices such as intra-aortic balloon pump, Impella, TandemHeart, and Venoatrial Extracorporal Membrane Oxygenation, as well as durable continuous-flow left ventricular assist devices (LVADs), improve cardiac output and blood flow to the vital organs. However, MCS use is associated with high rates of complications, including ischemic and hemorrhagic strokes which carry a high risk for death and disability. Improvements in MCS technology have reduced but not eliminated the risk of stroke. Mitigation strategies focus on careful management of anti-thrombotic therapies. While data on therapeutic options for stroke are limited, several case series reported favorable outcomes with thrombectomy for ischemic stroke patients with large vessel occlusions, as well as with reversal of anticoagulation for those with hemorrhagic stroke. Stroke in patients treated with MCS is associated with high morbidity and mortality. Preventive strategies are targeted based on the specific form of MCS. Improvements in the design of the newest generation device have reduced the risk of ischemic stroke, though hemorrhagic stroke remains a serious complication.

Abstract 14742: Driveline Infections Are Associated With Increased Hospitalizations Amongst Heartmate III Recipients

Introduction: The Heartmate III (Abbott, Chicago) is the only currently available durable left ventricular assist device (LVAD). Driveline infections (DLI) are a potential complication of durable mechanical circulatory support (MCS). We sought to analyze the impact of driveline infections on post-implantation outcomes. Methods: Consecutive patients who underwent implantation of a Heartmate III LVAD at our institution were analyzed. Patients were excluded if the device was placed as part of an exchange for another durable MCS device. Patients were followed until transplant, device exchange, death, or end of follow up. The primary outcome was the difference in number of hospitalizations and days hospitalized between patients with driveline infections compared to those without. Results: 130 patients (average age 59 years, 71% male) underwent implantation of a Heartmate III LVAD between September 2015 and March 2021. Over an average follow up of 23 months, 51 patients developed a documented DLI. The average time to DLI was 336 days. 90 percent of the initial DLI were caused by single organisms and 53 percent of these organisms were gram-positive. The number of total hospitalizations (2.6 vs. 5.9, p=0.00001) and total days hospitalized (28.8 vs. 62.7, p=0.0002) were increased in patients with DLI. Patients with DLI spent an average of 27 days hospitalized for reasons related to their DLI. 23 percent of patients with DLI required extended treatment with IV antibiotics for their first infection. 31 percent of patients with DLI were later transitioned from oral to extended treatment with intravenous antibiotics. 16 patients with DLI required debridement and 5 ultimately required device exchange. Conclusions: Despite improvement in device design and hemocompatibility, driveline infections remain a common source of morbidity for patients supported by Heartmate 3 LVAD and are associated with increased hospitalizations and hospitalization days. The potential morbidity should be discussed with patients prior to implantation and diligent care must be taken post-implantation to reduce the impact of this common complication.

Echocardiography in Cardiac Assist Devices.

In patients with medically refractory heart failure or cardiogenic shock, both temporary and durable mechanical circulatory support devices can be used to support cardiac circulation. Both transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) are widely available, relatively noninvasive, and avoid radiation exposure. Thus, echocardiography is an invaluable tool that provides vital information aiding in preprocedure evaluation, placement, management, and weaning of cardiac assist devices. The purpose of this article is to review the utility of both TTE and TEE in managing patients with cardiac assist devices.

Physical Properties of Blood and their Relationship to Clinical Conditions.

It has been long known that blood health heavily influences optimal physiological function. Abnormalities affecting the physical properties of blood have been implicated in the pathogenesis of various disorders, although the exact mechanistic links between hemorheology and clinical disease manifestations remain poorly understood. Often overlooked in current medical practice, perhaps due to the promises offered in the molecular and genetic era, the physical properties of blood which remain a valuable and definitive indicator of circulatory health and disease. Bridging this gap, the current manuscript provides an introduction to hemorheology. It reviews the properties that dictate bulk and microcirculatory flow by systematically dissecting the biomechanics that determine the non-Newtonian behavior of blood. Specifically, the impact of hematocrit, the mechanical properties and tendency of red blood cells to aggregate, and various plasma factors on blood viscosity will be examined. Subsequently, the manner in which the physical properties of blood influence hemodynamics in health and disease is discussed. Special attention is given to disorders such as sickle cell disease, emphasizing the clinical impact of severely abnormal blood rheology. This review expands into concepts that are highly topical; the relation between mechanical stress and intracellular homeostasis is examined through a contemporary cell-signaling lens. Indeed, accumulating evidence demonstrates that nitric oxide is not only transported by erythrocytes, but is locally produced by mechanically-sensitive enzymes, which appears to have intracellular and potentially extracellular effects. Finally, given the importance of shear forces in the developing field of mechanical circulatory support, we review the role of blood rheology in temporary and durable mechanical circulatory support devices, an increasingly utilized method of life support. This review thus provides a comprehensive overview for interested trainees, scientists, and clinicians.

Cardiogenic Shock

Abstract: Cardiogenic shock (CS) is the most common cause of death in hospitalized patients with acute myocardial infarction (AMI). The incidence and mortality of CS in hospitals is also high, although advanced therapy is widely used in CS patients. CS is a condition characterized by inadequate cardiac output due to primary cardiovascular diseases, leading to clinical and biochemical manifestations of insufficient tissue perfusion. CS complicates 5–10% of AMI. STEMI increases the risk of CS approximately twice as much as NSTEMI. In the last 10 years, in-hospital mortality due to CS that occurs in AMI has not changed, that is at 40-50%. The pathophysiology of CS shows several overlaps and can occur simultaneously, that is starting with a cardiac insult that reduces cardiac output, central hemodynamic changes, microcirculatory dysfunction, systemic inflammatory response syndrome, and multi-organ dysfunction. CS classification based on SCAI, divided into 5, that’s A(at risk), B(beginning CS), C(classic CS), D(deteriorating), and E(extremis). The key to managing CS is treating the patient as soon as possible, as each higher SCAI shock stage was associated with increased hospital mortality. All patients with suspected ACS-associated CS should have an early invasive strategy with appropriate revascularization. Vasoactive medicines have the potential to improve hemodynamics but at the expense of increased myocardial oxygen consumption and arrhythmogenic risk. Mechanical circulatory support (MCS) has insufficient data as the first-line device solution for CS patients. However, the use of durable MCS devices in a bridge-to-bridge strategy is becoming more prevalent and is supported by clinical recommendations. APACHE-III and SAPS-II, had the best mortality discrimination values to assess the outcome in CS patients.
 Keywords: cardiogenic shock, classification, heart failure, myocardial infarction, SCAI

Durable Mechanical Circulatory Support in Adult Congenital Heart Disease: Reviewing Clinical Considerations and Experience.

Adults with congenital heart disease (ACHD) patients are one of the fastest growing populations in cardiology, and heart failure (HF) is the most common cause of morbidity and mortality amongst them. The need for advanced HF therapies in ACHD patients stands to grow substantially. The anatomic considerations for placing durable mechanical circulatory support (MCS) devices in ACHD patients often require specialized approaches. Despite this, increasing evidence suggests that durable MCS can be implanted safely with favorable outcomes in ACHD patients. Expansion of MCS use in ACHD patients is imperative to improve their clinical outcomes. Knowledge of ACHD-specific anatomic and physiologic considerations is crucial to HF programs’ success as they work to provide care to this growing population.

Feasibility and role of echocontrast evaluation of patients with LVAD

Abstract Funding Acknowledgements Type of funding sources: None. Background In patients with Advanced heart failure (AHF) long-term support with durable mechanical circulatory support (MCS) devices such as left ventricular assist device (LVAD) brings survival benefits and improvement in quality of life, compared with conventional medical treatments. Development of RVF in patients with LVAD has a direct effect on mortality and is associated with prolonged length of stay in intensive care unit and in-hospital stay and with poor quality of life. Purpose: the evaluation of clinical safety and feasibility of echocontrast (EC) in patients implanted with 3 different types of LVAD (HeartWAre HVAD, Jarvik 2000, HeartMate 3); the assessment of the improvement in the visualization of heart structures; the intra and inter-operator agreement of RV measurements (FAC, TAPSE, sPAP, TR, regional wall motion abnormalities) with and without contrast. Methods: Between 2014 and 2019, 43 patients were implanted with LVAD, in particular 7 (16%) patients were implanted with Jarvik 2000, 31 (72%) with HeartMAte 3, 5 (12%) pts with HeartWAre HVAD. Nine patients (21%) either had contraindication or refused contrast injection. In 3 (7%) patients, it was technically challenging to obtain apical images at all levels. Two (5%) patients lost their follow-up. Our final population was of 29 (67%) patients. We also assessed the reproducibility of these measurements between two different expert operators (blind analysis). Results: We observed no allergic reaction to EC. Total 329 (64%) of 516 RV wall segments were available for qualitative analysis without contrast vs 451 (87%) with contrast (p < 0.001) with a significant improvement of the evaluability of regional contractility and FAC (41% vs 90%, p < 0.001). Evaluation of TAPSE, TR and sPAP was similar with and without contrast (p = NS) All the RV parameters showed little inter-operator variability when measured with contrast. TAPSE, FAC, and RWMA showed an excellent reproducibility (ICC >0.86) while it was good for 2D-baseline derived parameters (ICC = 0.74) showing improvement of inter operator reproducibility in the evaluation of regional contractility in the contrast echocardiography modality. Conclusion: EC is safe with all the types of LVAD we examined. Accurate and reproducible visualization of RV is imperative for reliability of information, a routine use of EC could play a pivotal role in interpreting RV features. EC improves RV morphologic and functional judgment; allowing greater accuracy and precision in the assessment of both global and regional RV functions. This finding may have important clinical improvement, especially in the future for analysis focused in RV prognostic role in LVAD patients

Heart Xenotransplant: A Door That Is Finally Opening.

Heart Xenotransplant: A Door That Is Finally Opening.

Mechanical Circulatory Support in Advanced Heart Failure

Advanced heart failure (HF) with persistent and progressive clinical decline despite maximal medical therapy portends a high mortality in the absence of advanced therapies, such as ventricular assist devices or heart transplantation. A subset of these advanced HF patients deteriorates into refractory cardiogenic shock, that is challenging to manage with vasoactive agents alone. Temporary mechanical circulatory support (MCS) device options have evolved over the years and provide a viable option to rescue and rest the myocardium of patients in cardiogenic shock. The goal of such therapy is to serve as bridge to recovery, or more often, a bridge to durable advanced therapies. For those patients with progressive advanced HF despite extensive medical therapy, durable MCS devices (ventricular assist devices) are available when heart transplantation is not feasible. In this article, we review currently available temporary and durable MCS devices, with a focus on their hemodynamic profiles, to inform optimal device selection for patients with advanced HF.

Mechanical Circulatory Support as a Bridge-to-Transplant Candidacy: When Does It Work?

Durable mechanical circulatory support (dMCS) devices can be offered as a bridge-to-transplant (BTT) or as a bridge-to-candidacy (BTC) strategy for candidates with contraindications to transplant listing, including pulmonary hypertension (BTC-PH), morbid obesity (BTC-Obes), social issues (BTC-Soc), or chronic illness (BTC-Illness). An understanding of the trajectory of BTC patients could guide future triage of advanced heart failure patients who are not candidates for transplantation. We performed a retrospective review all patients who underwent dMCS implantation as either BTT (206 patients) or BTC (114 patients) at our center from January 1, 2010, to March 31, 2020. There was no significant difference in mortality between BTC patients and BTT patients. Compared with the BTT group, significantly more patients in the BTC-PH group were transplanted (81% vs. 63%; p < 0.05) and significantly fewer patients in the BTC-Obes group (44%; p < 0.05) and BTC-Soc group (39%; p < 0.05) were transplanted. Additionally, the readmission rate was higher for those in the BTC-Obes (6.2 vs. 2.1; p < 0.05) and BTC-Soc (3.9 vs. 2.1; p < 0.05) groups. Bridge-to-candidacy patients generally had poorer post-dMCS trajectories than BTT patients. Centers should not be dissuaded from pursuing a BTC strategy for qualified patients; however, careful consideration of potential adverse outcomes is necessary.

Outcome of durable mechanical circulatory support devices in a tertiary care hospital in Saudi Arabia

Abstract Funding Acknowledgements Type of funding sources: None. Background Heart failure (HF) remains a significant cause of morbidity and mortality. Heart transplantation is the gold standard treatment for end stage heart failure. Durable mechanical circulatory support devices became a modality of treatment as bridge to transplantation or destination therapy because of the shortage of donor hearts. Objective To report the experience of durable mechanical circulatory devices in our tertiary care hospital as compared with the report of the International Society of Mechanically Assisted Circulatory Support (IMACS) registry. Results Between 2013 until December 2019, 73 durable mechanical circulatory support devices were implanted. Mean age 41.36 ±14.1 years and 83.6% of them were male. Etiology: 52.1% of the patients had dilated cardiomyopathy while 34.2% had ischemic cardiomyopathy. Age distribution: 45.2% of the patients were in the age group of 30-49 years while 32.9% were in the age group of 50-69 years. No devices were inserted in patients within the age group ≥70 years. Left ventricular assist devices with continuous pump flow accounted for 82.2% of implanted devices while biventricular support accounted for 15.1%. Total artificial hearts were implanted in 2.7% of the patients. INTERMACS categories at the time of implantation: 20.6% of patients were in INTERMACS I, INTERMACS II 38.4%, INTERMACS III 22%, INTERMACS IV17.6% while only 1.4% were INTERMACS V. Device strategy: 73.9% of devices were implanted as a bridge to candidacy for transplantation, 15.1 % were implanted as a bridge to cardiac recover, 8.2% were listed to heart transplantation while only 2.7% were left for destination therapy strategy. 50.7% of patients were discharged home after fulfilling education requirements. Forty per cent of the patients underwent heart transplantation. Major adverse events: 5.4% of the patients developed major cerebrovascular strokes after device implantation. Mediastinal significant bleeding and exploration occurred in 12.3% of patients and gastrointestinal bleeding in 8.2%. Driveline infection occurred in 16.4% of patients but only 2.7% had deep wound infection requiring urgent heart transplantation. Mortality on the device was 31.5%. Conclusion Our experience with mechanical circulatory support is similar to the reported major events and survival from the International Society of Mechanically Assisted Circulatory Support.

Neurocritical Care of Mechanical Circulatory Support Devices.

Mechanical circulatory support (MCS) devices have demonstrated improved survival outcomes in otherwise refractory cardiopulmonary failure but are associated with significant neurologic morbidity and mortality. This review aims to characterize MCS-associated brain injury and discuss the neurocritical care of this population. We found no practice guidelines or specific management strategies for the neurocritical care of patients with MCS devices. Acute brain injury was commonly observed in short-term and durable MCS devices. There is emerging evidence that a standardized neurological monitoring and management algorithm for MCS device-associated brain injury is feasible and potentially improves neurological outcomes. While MCS devices are associated with significant neurologic morbidity and mortality, there is scant evidence regarding optimal neuromonitoring and neurocritical care. With the increase in use of MCS devices for both short-term and durable applications, improved outcomes will depend on early identification and intervention of neurologic complications and further research into their pathophysiology.

First 5-year multicentric clinical trial experience with the HeartMate 3 left ventricular assist system

The HeartMate 3 (HM3) left ventricular assist system (Abbott, Abbott Park, IL) is a durable mechanical circulatory support device with unique features comprising a magnetically levitated rotor with a wide blood flow path and artificial pulse wave. 1 Schmitto JD Hanke JS Rojas SV Avsar M Haverich A First implantation in man of a new magnetically levitated left ventricular assist device (HeartMate III). J Heart Lung Transplant. 2015; 34: 858-860 Abstract Full Text Full Text PDF PubMed Scopus (129) Google Scholar

Single centre 12 year experience with durable mechanical circulatory support: comparison with the EUROMACS registry.

Mechanical circulatory support is an established therapy in end-stage heart failure. The EUROMACS registry was created to promote research in these patients. The aim of this report was to present our 12 year experience with the durable mechanical circulatory support devices and compare it with the EUROMACS registry. Data from the entire EUROMACS registry from January 2011 to April 2019 were included (4704 implantations in 4410 patients). During the 12 years of our experience, until April 2019,125 mechanical support devices were implanted, in 122 patients. We compare patients´ characteristics, operative data and results with the EUROMACS registry and we report the major complications during the observational period. Primary end-point (death) occurred in 40 (32.8 %) patients in our cohort during the follow-up period, representing the survival rate 75 %, 68 %, and 58 % for 6, 12, 24 months respectively, which compares favourably with the data, reported by the EUROMACS registry, the survival 66 % and 53 % after 1 and 2 years respectively. Cerebrovascular accident occurred in 7 %, a bleeding event in 32 %, significant infection (driveline) in 78 % and a device malfunction in 13 % of the patients. Forty- three patients underwent a heart transplant with hospital and long-term mortality of 11.6 % and 14 % respectively. Mechanical circulatory support is a valuable therapeutic option with excellent survival rates, nevertheless it is associated with clinically significant complications rates. The direct comparison between our cohort and the EUROMACS registry showed that early implantation strategy and mini invasive approach may improve survival rates and decrease postoperative complications (Tab. 3, Fig. 3, Ref. 16).

Right ventricular function and cardiopulmonary performance among patients with heart failure supported by durable mechanical circulatory support devices

Patients with continuous-flow left ventricular assist devices (CF-LVADs) experience limitations in functional capacity and frequently, right ventricular (RV) dysfunction. We sought to characterize RV function in the context of global cardiopulmonary performance during exercise in this population. A total of 26 patients with CF-LVAD (aged 58 ± 11 years, 23 males) completed a hemodynamic assessment with either conductance catheters (Group 1, n = 13) inserted into the right ventricle to generate RV pressure‒volume loops or traditional Swan‒Ganz catheters (Group 2, n = 13) during invasive cardiopulmonary exercise testing. Hemodynamics were collected at rest, 2 sub-maximal levels of exercise, and peak effort. Breath-by-breath gas exchange parameters were collected by indirect calorimetry. Group 1 participants also completed an invasive ramp test during supine rest to determine the impact of varying levels of CF-LVAD support on RV function. In Group 1, pump speed modulations minimally influenced RV function. During upright exercise, there were modest increases in RV contractility during sub-maximal exercise, but there were no appreciable increases at peak effort. Ventricular‒arterial coupling was preserved throughout the exercise. In Group 2, there were large increases in pulmonary arterial, left-sided filling, and right-sided filling pressures during sub-maximal and peak exercises. Among all participants, the cardiac output‒oxygen uptake relationship was preserved at 5.8:1. Ventilatory efficiency was severely abnormal at 42.3 ± 11.6. Patients with CF-LVAD suffer from limited RV contractile reserve; marked elevations in pulmonary, left-sided filling, and right-sided filling pressures during exercise; and severe ventilatory inefficiency. These findings explain mechanisms for persistent reductions in functional capacity in this patient population.

Less Invasive Left Ventricular Assist Device Implantation: One Right Step Toward the Future

Less Invasive Left Ventricular Assist Device Implantation: One Right Step Toward the Future

Perioperative management of patients with undergoing durable mechanical circulatory support.

Durable mechanical circulatory support (MCS) devices revolutionized the treatment options for patients with end-stage heart failure (HF). Implantation of durable mechanical support has become an integral treatment modality in end-stage HF patients and it is associated with improved quality of life and survival. There is no doubt that this needs an interdisciplinary and interprofessional approach of cardiac surgeons, cardiologists, cardiac anesthesiologists, perfusionists, intensivists, psychologists, assist device coordinators as well as physiotherapists and intensive care. Implantation of durable MCS is a challenging procedure for the anesthesiologist due to the patient’s characteristics and comorbid diseases. It demands comprehensive training, high vigilance and quick response during the acute hemodynamic changes occurring during the surgery. Preoperative risk stratification is of major importance to guide perioperative medical treatment strategies. Most of these patients have several comorbidities and multiple medications. Therefore, to anticipate postoperative end-organ dysfunction such as cognitive dysfunction, pulmonary or renal failure, an interdisciplinary approach is necessary to optimize patient’s prior surgery. Transthoracic and transesophageal echocardiography (TTE and TEE), both play an invaluable role in diagnosing the cause and guiding the management in different unstable clinical situations. Especially prevention of postoperative right HF with subsequent necessity of temporary MCS is important as it is associated with higher mortality. The aim of this review is to provide an overview about the current concepts of perioperative management for durable MCS. A multimodal standard operating procedure supports early recovery after surgery and intensive care stay. Standardized perioperative care helps to ensure optimal medical treatment. This review focusses on several major skills of perioperative management of these high-risk surgical patients.

Towards Designing a Better Death: A Retrospective Analysis of Planned In-Hospital LVAD Deactivation Cases

Despite rapid growth of implanted durable mechanical circulatory support devices, best practices for device deactivation and end of life (EOL) care have yet to be elucidated. We wished to describe current practices in LVAD deactivation at EOL, identify unmet needs of dying patients, and develop best-practice protocols for LVAD deactivation. Retrospective analysis of patients admitted at MedStar Washington Hospital Center who had planned LVAD deactivation prior to death between January 2017 and August 2019. EHR review extracted information regarding patient demographics, underlying cardiac history, LVAD implant course/complications, reasons for LVAD deactivation, clinical details of deactivation process including symptom management issues, unit of death, consultant participation, and family presence. Data was analyzed using descriptive statistics. Fifty-three patients (32% women, 67% African American, 64% non-ischemic cardiomyopathy) with median 267 days on durable MCS support (range 10-3326 days) were included in the analysis. Fourteen deaths occurred during LVAD index hospitalization; for the rest, patients sought hospital or emergency room care a median of twice in the year prior to death (range 0-16 occurrences). Final hospital length-of-stay was median 21 days (range 1-106). During planning for LVAD deactivation, PC was consulted in 33 cases (66%), hospital chaplaincy in 27 (51%), and ethics in 13 (25%). Forty deaths occurred in the hospitals cardiac ICUs, 12 in the advanced heart failure step-down unit, and 1 in the ED. Family members were present at deactivation in 39 cases (74%). Regarding EOL symptom management, at the time of deactivation most patients received opioids (94%) and benzodiazepines (66%). LVAD deactivation time was documented in only 18 cases (34%); in these cases, time from device deactivation to death was median 11 minutes (range 1 min to nearly 28 hours). Our early outcomes identify existing practices that should be continued as well as opportunities to develop and implement best-practice protocols for LVAD deactivation, palliative symptom management, psychosocial/spiritual support, and ongoing education for involved providers.This retrospective case series review informs the creation and implementation of future collaborative LVAD deactivation policies and workflow guidelines.

Durable mechanical circulatory support device use in the United States by geographic region and minority status

BackgroundDurable mechanical circulatory support device (MCSD) therapy has experienced rapid dissemination in the United States. Few studies have evaluated geographic patterns of its dissemination based upon patient characteristics that could identify potential variation in its application. MethodsA combined Interagency Registry for Mechanically Assisted Circulatory Support and Medicare dataset identified durable MCSD implants from 2008 through 2014. MCSD implant rates were estimated using yearly US Census population data, estimated from the Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research database and stratified by age, race, and United Network for Organ Sharing (UNOS) region. ResultsOverall, 16,331 patients received an MCSD implant from 232 unique centers. Annual MCSD implant rate (per 1 million population) significantly increased in each UNOS region (absolute range of increase, 5.3-16.4) with UNOS Region 7 demonstrating the highest overall absolute rate (20.9) in 2014 and UNOS Region 11 demonstrating the greatest relative increase in rate (430.5%). Geographical differences in the rate of MCSD implants were observed among whites and minorities with higher rates of MCSD implants observed for minorities for nearly all UNOS regions across all years. Significantly greater relative increases in MCSD implants for minorities compared with whites were observed within UNOS Regions 2, 3, 6, 7, 8, 9, and 11 (P < .001). ConclusionsGeographical differences exist in rates of MCSD implantation among whites and minorities. The reasons for these differences are unknown, but may reflect underlying differences in disease burden or disparities in access to heart transplantation and warrant further study.

Anticoagulation Reversal and Risk of Thromboembolic Events Among Heart Transplant Recipients Bridged with Durable Mechanical Circulatory Support Devices.

Anticoagulation reversal agents (ARAs) can minimize bleeding complications associated with mechanical circulatory support devices (MCSDs) explantation at the time of heart transplantation (HT); data on thromboembolic (TE) risk associated with ARAs are limited in this patient population. In this single-center study, we retrospectively analyzed 118 consecutive adults who were supported with durable MCSDs and underwent HT between May 2013 and October 2016. Patients were categorized based on intraoperative use of ARAs (recombinant factor VIIa [n=23], 4-factor prothrombin complex concentrate [n=48], or factor IX complex [n=2]) at the time of HT; these agents were used at discretion of implanting surgeons for bleeding control. The primary outcome of interest was presence of venous or systemic TE events within 3 months of HT. Multivariable logistic regression analyses were used to assess association between TE events and use of ARAs. A total of 71 (60%) patients received ARAs, and a total of 32 patients (27.1%) had TE events (25 venous [median time to diagnosis: 11.5 days; interquartile range {IQR}: 9-31 days], and 10 systemic [median time to diagnosis: 5.5 days; IQR: 4-8 days]); 26 (81.2%) of those with TE events had ARAs used at the time of HT. Multivariable analysis identified use of ARAs as an independent predictor of TE events (multivariable odds ratio: 3.06; 95% CI: 1.09-8.58; p = 0.034). Unplanned intraoperative use of ARAs to control bleeding was associated with a significantly higher risk of TE events among HT recipients bridged with durable MCSD. Future studies are required to further assess safety of these agents and their impact on patient outcomes.