Left Ventricular Assist Device Thrombosis Research Articles

Abstract 13507: Outcomes Among Coronary Artery Disease Patients Hospitalized for Left Ventricular Assist Device Implantation: A United States Population-Based Cohort Study

Introduction: Coronary Artery Disease (CAD) is a significant cause of morbidity and mortality among the general population. Previous studies suggested that significant CAD increased the risk for adverse outcomes including acute coronary syndrome and ischemic cardiomyopathy, which if severe enough warrants advance therapeutic options including implantation of a left ventricular assist device (LVAD). However, there is paucity of data exploring the in-hospital outcomes of patients with CAD admitted for LVAD implantation. Hypothesis: CAD does not impact outcomes in patients undergoing LVAD implantation. Methods: A retrospective cohort study using the National Inpatient Sample 2018-2020 database. Patients aged > 18 years with known CAD admitted for LVAD placement were identified in the database. Multivariate logistic regression analysis was used to adjust for potential patients' and hospital level confounders. Outcome of interest were in-hospital mortality, ST-Elevation Myocardial Infarction (STEMI), LVAD thrombosis and ischemic stroke among patients with CAD hospitalized for LVAD implantation. Results: We identified a total of 76,757 patients admitted for LVAD implantation in the years 2018-2020, of which 55.93% (n= 42,930/76,757) had CAD. The overall mortality rate among patients admitted for LVAD implantation was 27.47% (n=21,080/76,757). Among those with concomitant CAD, the mortality rate was significantly higher at 28.93% (12,263/42,930, P=0.00). Using a stepwise survey multivariable logistic regression model that adjusted for patient and hospital level confounders, concomitant CAD among LVAD recipients was found to be an independent predictor of overall in-hospital mortality (aOR 1.24; 95% CI (Confidence Interval), 1.14-1.36; p<0.001) but did not increase the risk of STEMI (aOR 1.48; 95% CI, 0.98-1.34; p=0.09), LVAD thrombosis (aOR 1.04; 95% CI, 0.51-2.14; p=0.91) and ischemic stroke (aOR 0.76; 95% CI, 0.38-1.39; p=0.33). Conclusions: Among hospitalized patients for LVAD implantation, concurrent CAD increased the risk for in-hospital mortality but did not increase the risk for STEMI, LVAD thrombosis and ischemic stroke. Prospective studies with control of potential confounders may better delineate these associations.

Prognostic value of mitral regurgitation in patients undergoing left ventricular assist device deployment: A systematic review and meta-analysis.

Left ventricular assist devices (LVADs) represent an important therapeutic option for patients progressing to end-stage heart failure. LVAD has previously been shown to have a promising role in improving mitral regurgitation (MR). Nevertheless, the prognostic value of preoperative uncorrected MR in this population remains unclear. A systematic database search with meta-analysis was conducted of comparative original articles of patients with preoperative mild MR (Grade 0-I) versus moderate-severe MR (Grade II-III) undergoing LVAD implantation, in EMBASE, MEDLINE, Cochrane database, and Google Scholar, from inception to June 2022. Primary outcomes were overall and operative mortality. Secondary outcomes were neurological dysfunction, gastrointestinal bleeding, right heart failure, LVAD thrombosis, and driveline infection. Our search yielded 2228 relevant studies. A total of 19 studies met the inclusion criteria with a total of 11 873 patients. LVAD caused a statistically significant decrease of 35.9% in the number of patients with moderate-severe MR (grade II-III) postoperatively. No significant difference was observed in terms of overall mortality, operative mortality, GI bleeding, LVAD thrombosis, and driveline infection rates between mild and moderate-severe MR. An increased rate of right heart failure was seen among patients with moderate-severe MR, while lower rates of neurological events were also observed. LVAD improves the haemodynamics of the left ventricle, to promote resolution of MR. Nevertheless, the severity of preoperative mitral regurgitation in patients undergoing LVAD deployment does not seem to affect mortality.

Left ventricular functional improvement appears to contribute to lower rates of device thrombosis in patients on durable mechanical circulatory support

By unloading the failing heart, left ventricular (LV) assist devices (LVADs) provide a favorable environment for reversing adverse structural and functional cardiac changes. Prior reports have suggested that an improved native LV function might contribute to the development of LVAD thrombosis. We used the Interagency Registry for Mechanically Assisted Circulatory Support and found that LV functional improvement is associated with a lower risk for device thrombosis. The risk for cerebrovascular accident and transient ischemic attack was comparable across post-LVAD LV function subgroups, while the risk of hemolysis was lower in subgroups of patients with better LV function on LVAD support.

Sex disparities in left ventricular assist device implantation outcomes: A systematic review and meta-analysis of over 50 000 patients.

Left ventricular assist devices (LVAD) represent an important therapeutic option for patients progressing to end-stage heart failure. Women have been historically underrepresented in LVAD studies, and have been reported to have worse outcomes despite technological optimisation. We aimed to systematically explore the evidence on sex disparities in the use and outcomes of LVAD implantation. A systematic database search with meta-analysis was conducted of comparative original articles of men versus women undergoing LVAD implantation, in EMBASE, MEDLINE, Cochrane database and Google Scholar, from inception to July 2022. Primary outcomes were stroke (haemorrhagic and ischaemic) and early/overall mortality. Secondary outcomes were LVAD thrombosis, right VAD implantation, major bleeding, kidney dysfunction, and device/driveline infection. Our search yielded 137 relevant studies, including 22 meeting the inclusion criteria with a total of 53 227 patients (24.2% women). Overall mortality was higher in women (odds ratio [OR] 1.35, 95% confidence interval [CI] 1.05-1.62, p= 0.02), as was overall stroke (OR 1.32, 95%CI 1.06-1.66, p= 0.01), including ischemic (OR 1.80, 95%CI 1.22-2.64, p= 0.003) and haemorrhagic (OR 1.72, 95%CI 1.09-2.70, p= 0.02). Women had more frequent right VAD implantation (OR 2.11, 95%CI 1.24-3.57, p= 0.006) and major bleeding (OR 1.40, 95%CI 1.06-1.85, p= 0.02). Kidney dysfunction, LVAD thrombosis, and device/driveline infections were comparable between sexes. Our analysis suggests that women face a greater risk of adverse events and mortality post-LVAD implantation. Although the mechanisms remain unclear, the difference in outcomes is thought to be multifactorial. Further research, that includes comprehensive pre-operative characteristics and post-operative outcomes, is encouraged.

Accelerated LVAD pump thrombosis in COVID-19 patient: Case report and mini review.

Coronavirus (COVID-19) infection exposes patients with heart failure specially who are on mechanical support to a higher risk of morbidity and mortality. To investigate the impact of COVID-19 infection on left ventricular assist device (LVAD) thrombosis in heart failure patients. We searched the medical electronic records, Medline, PubMed and Cochrane databases for; (LVAD) AND (thrombosis)) AND (covid-19)) AND (heart failure). We divided cases reported into, LVAD thrombosis with COVID-19 infection and compare them with LVAD thrombosis without COVID-19 infection. Demographic data, LVAD device, presentation, treatment and outcomes were reviewed in all the LVAD thrombosis patients. In addition to our case, 8 other cases of LVAD thrombosis associated with COVID and 9 cases of LVAD thrombosis without covid infection were found. Patients with Covid infection had worse presentation and outcomes (3 deaths VS. 1 death in non-covid group). In LVAD patients, pump malfunction due to thrombus development in the inflow cannula, device body, or outflow graft can result in hemodynamic instability, hemolysis and other life-threatening complications. COVID infection significantly increases the risk of mortality in LVAD patient by accelerating the pump thrombosis due to elevated levels of endothelial protein C receptor and thrombomodulin along with procoagulants such as factor VIII, P-selectin, and von Willebrand factor. Significant morbidity and mortality are attributed to LVAD thrombosis, which are exasperated by prothrombotic conditions created in COVID-19 infections.

Clinical Case 26—Is it possible to live with thrombosed left ventricular assist device (LVAD)?

Abstract LVAD HeartWare was implanted in a 63-year-old patient with end-stage dilated cardiomyopathy. The postoperative course was complicated by massive gastrointestinal (GI) bleeding that required surgical exploration of the GI tract. For the next 1.5 years, the patient has significantly improved functional capacity with proper LVAD function. A month before the incident, an alarm indicating a pump malfunction was recorded. The patient presents with congestive symptoms and an altered sound of LVAD. Laboratory indicates seven times elevated LDH values, low HGB and INR 3.03. Thrombophilia tests were negative. Echo examination does not indicate pump thrombosis, but the pump parameters show increased energy consumption (>6 W) and increased flow (>7 L/min). A diagnosis of LVAD thrombosis was made. Fibrinolytic therapy was contraindicated because of a history of GI bleeding, so a continuous infusion of heparin was started. Despite this, the patient's clinical condition deteriorates, and a decision was made to discontinue the LVAD, to prevent further hemolysis that led to acute kidney injury (AKI). The procedure was performed without endangering the patient. Massive hemolysis, however, leads to the progressive development of AKI requiring CVVHDF. Global respiratory insufficiency develops and mechanical ventilation was started. After six days of intensive treatment, the patient recovered and was discharged home with a thrombosed pump. For the next 2.5 years, the patient was in satisfactory condition during follow-ups, the pump was not explanted. Even sophisticated medical devices carry with them risks for the patient's life despite adequate management. Treatment of LVAD thrombosis depends on patient characteristics and pump-related factors.

Health-Related Quality of Life Analysis Supports the Recommendation for HeartMate3 Implantation without Concomitant Mitral Valve Surgery

<h3>Purpose</h3> Functional mitral valve regurgitation (MR) is common in patients with end-stage heart failure awaiting left ventricular assist device (LVAD) implantation. The resolution of functional MR in LVAD patients has been detected for different LVAD types and across all grades of MR severity. However, it should be proven if the health-related quality of life (HRQoL) after LVAD implantation is comparable in patients with different preoperative MR grades. <h3>Methods</h3> We performed a single-center HRQoL analysis including 34 patients with HeartMate 3 (HM3) implantation using the SF12 Health Survey and the Hospital Anxiety and Depression Score (HADS) at least 1 year after LVAD implantation. The study groups were classified according to echocardiographically defined grade of MR. The group without severe MR (none, mild or moderate MR) comprised 24 patients; the group with severe MR comprised 10 patients. Clinical characteristics including the six-minute walk test (6MWT) were documented. <h3>Results</h3> Age, gender, history of prior heart valve surgery as well as the rate of heart transplantation, ECMO and RVAD implantation, right heart failure, ventricular arrhythmias, stroke, suction events, LVAD thrombosis, and bleeding events were comparable between LVAD patients with severe and not severe MR (p < 0.05). The 6MWT was comparable in the postoperative period (p = 0.13) and one year after LVAD implantation (p = 0.57). No significant differences were apparent in the SF-12-determined physical health (severe MR: 36.6 ± 8.4; not severe MR: 40.1 ± 9.3; p = 0.32) and mental health (severe MR: 49.5 ± 9.7; not severe MR: 54.3 ± 10.5; p = 0.22) as well as in the HADS-determined anxiety (severe MR: 5.6 ± 3.6; not severe MR: 4.9 ± 3.3; p = 0.58) and depression grade (severe MR: 6.3 ± 3.7; not severe MR: 4.6 ± 4.1; p = 0.28). <h3>Conclusion</h3> Physical and mental health as well as anxiety and the depression grade that were measured with standardized questionnaires are comparable in LVAD patients with preoperative severe and not severe MR. The results of this HRQoL pilot study support the recommendation of the International Society for Heart and Lung Transplantation for a HM3 implantation without concomitant MV repair and replacement.

Slow It Down: A Case Report Of Microangiopathic Hemolytic Anemia In A Heartmate III Patient

<h3>Introduction</h3> Incidence of hemolysis in left ventricular assist devices (LVADs) is reported from 13-18%, but with HeartMate 3 (HM3) LVAD has been decreased to <1%. Typically, hemolysis is associated with LVAD thrombosis with subsequent decreased survival rate at 1 year (38.9% vs. 89.3%). We present a case of microangiopathic hemolytic anemia (MAHA), not related to pump thrombosis in a recent implanted HM3 LVAD patient which resolved by decreasing LVAD speed. <h3>Case Report</h3> A 44 year-old man with status post LVAD HM3 4 months prior complicated with right ventricular (RV) failure, pulmonary hypertension and CKD Stage III was admitted for mixed vasodilatory and cardiogenic shock. Patient required dual inotropes, vasopressors and temporary renal replacement therapy in an effort to stabilize him and continue his evaluation for heart and kidney transplant. Meanwhile, patient developed acute, severe thrombocytopenia (platelet count of 26K) and mild anemia. Disseminated intravascular coagulation was unlikely (normal fibrinogen level). Heparin-induced thrombosis (HIT) antibody testing was non-reactive. No active sepsis. There were no power spikes or suspected LVAD thrombosis (Table 1). Intrinsic bone marrow disease was thought to be unlikely. LDH was elevated and haptoglobin level undetectable (Table 2), blood smear showed schistocytes, raising suspicious for MAHA, therefore LVAD speed was decreased to 5100 RPM to diminish red blood cell (RBC) fragmentation and maintained in systemic unfractionated heparin infusion. This resulted in recovery of platelets and hemolysis parameters (Table 2). Ultimately, patient underwent dual organ transplantation without complications. <h3>Conclusions</h3> Per our knowledge, this is the first case reported of MAHA in a LVAD HM3 patient, not related to pump thrombosis that resolves with decrease in LVAD speed. MAHA is caused by mechanical injury of RBCs. The effective treatment in this scenario was to decrease the speed of the LVAD, hypothetically to decrease excessive shear in circulation. Further research should be done to delineate efficacy of reducing LVAD speed in these patients.

Successful Thrombolytic Therapy in a Suspected Case of HeartMate 3 LVAD Thrombosis

IntroductionAlthough less common with the HeartMate 3 (HM3), pump thrombosis remains a life-threatening complication of durable left ventricular assist devices (LVAD). We present what we believe is the first case of suspected pump thrombosis in a patient with a HM3 LVAD that was successfully managed with tissue plasminogen activator (tPA).Case ReportA 22-year-old man who underwent HM3 implantation for end stage heart failure due to left ventricular non-compaction presented after experiencing two low flow alarms. His physical examination was notable for tachycardia at 125 beats per minute and an elevated Doppler mean blood pressure of 92 mm Hg. LVAD interrogation revealed low flows without power spikes (Figure 1A). Within 24 hours, he developed persistent hypotension requiring vasopressor support and multiple low flow alarms. Serial laboratory results were notable for rising LDH, peaking at 4,741 U/L and acute liver injury with AST 2,712 U/L, ALT 798 U/L and INR 5.2. Transthoracic echocardiography and computed tomography (CT) angiography did not reveal any obvious thrombus. Given this constellation of findings, pump thrombosis was suspected. Following multidisciplinary discussion, unfractionated heparin bolus and infusion were started. After an unremarkable head CT, heparin was stopped and systemic tPA was given at a dose of 5 mg over one minute followed by 10 mg over 10 minutes due to ongoing liver dysfunction. Heparin was resumed after PTT returned to therapeutic range. Immediately post tPA infusion, his LVAD flows improved from 2.3 L/min to 4.1 L/min (Figure 1B). Vasopressor support was quickly weaned. LDH, creatinine, and liver enzymes improved over the following days. Warfarin was resumed on day 14 of admission. He was discharged on aspirin, clopidogrel and warfarin.SummaryThrombolytics may be a potential therapeutic option in select cases of HM 3 pump thrombosis. Further research is warranted to delineate LVAD parameters that facilitate early recognition of pump thrombosis and successful medical management. Although less common with the HeartMate 3 (HM3), pump thrombosis remains a life-threatening complication of durable left ventricular assist devices (LVAD). We present what we believe is the first case of suspected pump thrombosis in a patient with a HM3 LVAD that was successfully managed with tissue plasminogen activator (tPA). A 22-year-old man who underwent HM3 implantation for end stage heart failure due to left ventricular non-compaction presented after experiencing two low flow alarms. His physical examination was notable for tachycardia at 125 beats per minute and an elevated Doppler mean blood pressure of 92 mm Hg. LVAD interrogation revealed low flows without power spikes (Figure 1A). Within 24 hours, he developed persistent hypotension requiring vasopressor support and multiple low flow alarms. Serial laboratory results were notable for rising LDH, peaking at 4,741 U/L and acute liver injury with AST 2,712 U/L, ALT 798 U/L and INR 5.2. Transthoracic echocardiography and computed tomography (CT) angiography did not reveal any obvious thrombus. Given this constellation of findings, pump thrombosis was suspected. Following multidisciplinary discussion, unfractionated heparin bolus and infusion were started. After an unremarkable head CT, heparin was stopped and systemic tPA was given at a dose of 5 mg over one minute followed by 10 mg over 10 minutes due to ongoing liver dysfunction. Heparin was resumed after PTT returned to therapeutic range. Immediately post tPA infusion, his LVAD flows improved from 2.3 L/min to 4.1 L/min (Figure 1B). Vasopressor support was quickly weaned. LDH, creatinine, and liver enzymes improved over the following days. Warfarin was resumed on day 14 of admission. He was discharged on aspirin, clopidogrel and warfarin. Thrombolytics may be a potential therapeutic option in select cases of HM 3 pump thrombosis. Further research is warranted to delineate LVAD parameters that facilitate early recognition of pump thrombosis and successful medical management.

De Ritis-adjusted AST provides comparable efficacy to lactate dehydrogenase as a biomarker for detection of LVAD hemolysis or thrombosis.

Lactate hydrogenase (LDH) is a common biomarker utilized in the detection and monitoring of left ventricular assist device (LVAD) hemolysis and thrombosis. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are common laboratory tests that can be used to calculate the De Ritis ratio and the De Ritis adjusted AST. A retrospective review of LVAD patients was performed to identify three cohorts of patients: those with confirmed pump thrombosis after device exchange, those with LVAD-related hemolysis who were medically managed without pump exchange, and those who did not meet these criteria and served as the control cohort. Evaluation of AST, AST/ALT ratio (referred to as the De Ritis ratio) as well as AST x (AST/ALT) or the De Ritis-adjusted AST (DRA) was performed. There were 29 patients who underwent device exchange for thrombosis, 25 patients who were diagnosed with hemolysis and treated medically (clopidogrel (N=6), heparin (N=13), tirofiban (N=8), eptifibatide (N=2), and some received more than one of these treatments), and 425 control patients. A qualitatively comparable relative and absolute rise in DRA and LDH were found in both surgically managed pump thrombosis and suspected device-related hemolysis. Both AST and LDH as well DRA are significantly associated with pump thrombosis (p < 0.0001 for each). DRA is a potential screening biomarker for hemolysis and device thrombosis in stable left ventricular assist device patients.

Left Ventricular Assist Device Thrombosis: Combined Approach by Echocardiography and Logfiles Review for Diagnosis and Management

IntroductionLeft ventricular assist devices are an established therapy for end-stage heart failure. Follow-up of these patients showed complications, such as thrombosis. Our objective was to evaluate the contribution of echocardiography — in association with HeartWare HVAD online logfiles reviews and lactate dehydrogenase titration — for diagnosis and treatment of thrombosis.MethodsSeventeen episodes of thrombosis were diagnosed in 8/20 patients with HVAD. Diagnosis was made by trans-thoracic echocardiographic blood flow velocities, logfiles review of power consumption and pump flows, and titration of lactate dehydrogenase. Data were collected at baseline routine control (Group A), during thrombosis (Group B), after thrombolysis (Group C).ResultsThrombolysis was successful in all cases; one patient died of cerebral haemorrhage. Echocardiographic maximal blood flow velocity near the inflow cannula was 598±42 cm/sec (Group B), 379.41±21 cm/sec (Group C), and 378.24±28 cm/sec (Group A) (P<0.00001). In eight (47%) cases, thrombi were visualized in the left ventricle by three-dimensional modality. Logfiles recordings of blood flows were 9.52±0.9 L/min (Group B), 4.02±0.4 L/min (Group C), and 4.04±0.4 L/min (Group A) (P<00001). Power consumption was 5.01±0.7 W (Group B), 3.45±0.2 W (Group C), and 3.46±0.2 W (Group A) (P<0.00001). Lactate dehydrogenase was 756±54 IU (Group B), 234±22 IU (Group A), and 257±36 IU (Group C) (P<0.00001).ConclusionsEchocardiography of increased maximal velocity near the inflow cannula is a sign of HVAD obstruction. Logfile reviews provide a clear picture of HVAD obstruction. Combination of echocardiographic data and review of logfiles detects signs of left ventricular assist devices thrombosis leading to a successful treatment.

Postimplant Phosphodiesterase-5 Inhibitor Use in Centrifugal Flow Left Ventricular Assist Devices

ObjectivesThis study examined the association between phosphodiesterase-5 inhibitor (PDE-5i) use and outcomes in patients with contemporary centrifugal flow left ventricular assist devices (LVADs). BackgroundPDE-5i use may affect outcomes in patients with continuous flow LVADs. MethodsPatients enrolled in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support), with HeartMate 3 (n = 4,628) or HeartWare Ventricular Assist Device (HVAD) (n = 2,601) implant were included in the analysis. The mean duration of follow-up was 11.94 ± 8.65 months. PDE-5is were used in 2,173 patients. The primary endpoint was the composite of all-cause mortality, ischemic stroke, and pump thrombosis. Propensity matching and stabilized inverse probability of treatment weights were used to adjust for baseline differences between patients receiving and not receiving PDE-5i. Adjusted Cox proportional hazards analysis was performed for each outcome. ResultsThe primary endpoint was lower in the PDE-5i group (adjusted HR: 0.77; 95% CI: 0.69-0.86; P < 0.0001; HeartMate 3: adjusted HR: 0.77; 95% CI: 0.64-0.92; P = 0.0044; HVAD: adjusted HR: 0.76; 95% CI: 0.66-0.88; P = 0.0002). All-cause mortality was lower with PDE-5is (adjusted HR: 0.75; 95% CI: 0.65-0.86; P < 0.0001; HeartMate 3: adjusted HR: 0.70; 95% CI: 0.57-0.86; P = 0.0007; HVAD: adjusted HR: 0.78; 95% CI: 0.65-0.94; P = 0.0098) and fewer ischemic strokes with PDE-5is were observed (adjusted HR: 0.71; 95% CI: 0.56-0.89; P = 0.003; HeartMate 3: adjusted HR: 0.67; 95% CI: 0.45-0.99; P = 0.045; HVAD: adjusted HR: 0.73; 95% CI: 0.56-0.97; P = 0.03). LVAD thrombosis was unchanged with PDE-5is, with overall low event rates observed. ConclusionsPostimplant PDE-5i use was associated with lower mortality and ischemic strokes in patients with centrifugal flow LVADs.

Phenomapping a Novel Classification System for Patients With Destination Therapy Left Ventricular Assist Devices

Patients with continuous flow destination therapy (DT) left ventricular assist devices (LVAD) comprise a heterogeneous population. We hypothesized that phenotypic clustering of individuals with DT LVADs by their implantation characteristics will be associated with different long-term risk profiles. We analyzed 5,999 patients with continuous flow DT LVADs in Interagency Registry for Mechanically Assisted Circulatory Support using 18 continuous variable baseline characteristics. We Z-transformed the variables and applied a Gaussian finite mixture model to perform unsupervised clustering resulting in identification of 4 phenogroups. Survival analyses considered the competing risk for cumulative incidence of transplant or the composite end point of death or heart transplant where appropriate. Phenogroup 1 (n=1,163, 19%) was older (71 years) and primarily white (81%). Phenogroups 2 (n=648, 11%) and 3 (n=3,671, 61%) were of intermediate age (70 and 62 years), weight (85 and 87 kg), and ventricular size. Phenogroup 4 (n=517, 9%) was younger (40 years), heavier (108 kg), and more racially diverse. The cumulative incidence of death, heart transplant, bleeding, LVAD malfunction, and LVAD thrombosis differed among phenogroups. The highest incidence of death and the lowest rate of heart transplant was seen in phenogroup 1 (p <0.001). For adverse outcomes, phenogroup 4 had the lowest incidence of bleeding, whereas LVAD device thrombosis and malfunction were lowest in phenogroup 1 (p <0.001 for all). Finally, the incidence of stroke, infection, and renal dysfunction were not statistically different. In conclusion, the present unsupervised machine learning analysis identified 4 phenogroups with different rates of adverse outcomes and these findings underscore the influence of phenotypic heterogeneity on post-LVAD implantation outcomes.

Left Ventricular Assist Device Thrombosis Treated with Intravenous Tissue Plasminogen Activator in a Patient with COVID-19 Infection

Left ventricular assist device (LVAD) implantation is an established treatment for patients with end-stage, systolic heart failure as a bridge to heart transplantation or destination therapy. LVAD pump thrombosis is a life-threatening complication than can be triggered by prothrombotic conditions such as infection. Management of pump thrombosis presents as both a diagnostic and therapeutic challenge that is associated with a high morbidity and mortality. We report a case of pump thrombosis in a patient with a HeartMate II (Abbott Laboratories, Chicago, IL) and coronavirus (COVID-19) infection that was treated successfully with an intravenous thrombolytic, tissue plasminogen activator.

Identification of characteristics, risk factors, and predictors of recurrent LVAD thrombosis: conditions in HeartWare devices

BackgroundRedictors of repetitive left-ventricular assist device (LVAD)-thrombosis have not been studied yet.MethodsWe identified predictors of recurrent LVAD thrombosis in HeartWare (HVAD) patients in a long-term study from 2010 until 2020. We included all patients with two or more thrombolysis treatments for repetitive HVAD thrombosis and effectiveness of thrombolytic therapy was defined as freedom from stroke, death, another HVAD thrombosis, or surgical device exchange within 30 days after the event. Study endpoints also include all-cause mortality and heart transplantation.ResultsA total of 534 HVAD implantations have been screened, and 73 patients (13.7%) developed first HVAD thrombosis after a median of 10 months (IQR; 6–21 months). 46 of these patients had effective thrombolysis in 71.7% (n = 33/46). After a median of 14 months (IQR 4–32 months) follow-up, 17 patients (51.5%) had developed a second HVAD thrombosis and all were treated with t-PA therapy again, resulting in effectiveness in 76.5% (n = 13/17). The four patients with ineffective t-PA therapy underwent subsequent surgical HVAD exchange. Multiple Cox regression model analysis revealed time interval between HVAD implantation and first thrombosis as an independent risk factor of recurrent thrombosis (HR, 0.93, 95% CI 0.87–0.99, p = 0.031). Kaplan–Meier analysis at 3 year follow-up showed no significant difference in overall survival for recurrent vs non-recurrent thrombosis groups (log-rank test, p = 0.959).ConclusionRecurrent HVAD thrombosis mostly appears within 12 months after first thrombosis. Systemic t-PA therapy for recurrent pump thrombosis seems safe, achieving comparable effectiveness rates to initial t-PA therapy. Survival does not differ between patients with or without recurrent HVAD thrombosis.

Abstract 15226: The Impact of Chronic Obstructive Pulmonary Disease on In-hospital Outcomes Following Left Ventricular Assist Device Implantation

Background: Chronic obstructive pulmonary disease (COPD) is well-known cause of ventricular dysfunction. However, in the setting of patients with advanced heart failure undergoing left ventricular assist device (LVAD) implantation, there is paucity data on COPD influence on in-hospital outcomes. Methods: This retrospective cohort study based on the Nationwide Inpatient Sample included all patients above 18 years all who underwent LVAD implantation from 2011 to 2017. All data was weight as recommended by Healthcare Cost and Utilization Project.Multivariate logistic regression was used to evaluate the impact of COPD on in-hospital outcomes. Results: A total of 25,503 patients underwent LVAD implantation, of those 13.8% had a pre-existing diagnosis of COPD. Individuals with COPD were older (median 62 vs. 58 years, p&lt;0.001), more commonly male (82% vs. 76.4%, p&lt;0.001). Patient with COPD had a greater burden of comorbidities confirmed by significant higher rate of hypertension, diabetes, atrial tachyarrhythmias, dyslipidemia, prior stroke, coronary and peripheral artery diseases, pulmonary hypertension, and chronic kidney disease (p&lt;0.001 for all). No significant difference was found in in-hospital stroke, infections, short-term percutaneous mechanical circulatory support, implant related complications, and LVAD thrombosis. There was a significant higher rate of inpatient acute kidney injury, major bleeding, cardiac complications, thromboembolism, and cardiac arrest in patients without COPD (p&lt;0.05 for all outcomes). Compared to patients without COPD, individuals with COPD had a lower mortality (6.2% vs. 12.4%; OR 0.59; C.I. 0.512-0.685; p&lt;0.05). Conclusion: Patients with COPD undergoing LVAD implantation have higher comorbidities, however, it is not associated with increase in-hospital all-cause mortality.Further studies are needed to analyze the differences found between these two groups in more detail.

Abstract 14574: Assessing Cardiovascular, Thrombotic and Bleeding Outcomes in Patients With Chronic Liver Disease Undergoing Left Ventricular Assist Device Implantation: Analysis of the National Inpatient Sample Database

Introduction: Coagulopathy and hematologic abnormalities are major concerns in patients with chronic liver disease (CLD) and refractory heart failure which combined with the use of anticoagulation or anti-platelet therapy, may affect perioperative outcomes in patients undergoing left ventricular assist device (LVAD) implantation. Methods: The National Inpatient Sample Database was queried from 2012 to 2017 for relevant International Classification of Diseases (ICD)-9 and ICD-10 procedural and diagnostic codes. Baseline characteristics and in-hospital outcomes were compared in patients with chronic liver disease and those without, who underwent LVAD implantation. Results: A total of 23,435 patients underwent LVAD implantation, 2,200 patients with CLD and 20,755 patients without CLD. See Table 1 for baseline characteristics. All-cause inpatient mortality (14.8% vs. 11.1%, p&lt;0.001), major bleeding (34.3% vs. 30.2%, p&lt;0.001), transfusion of platelets (18.0% vs. 14.0%, p&lt;0.001), and the occurrence of a subarachnoid hemorrhage (1.6% vs. 0.7%, p&lt;0.001) were greater in patients with CLD. LVAD thrombosis (6.6% vs. 9.4%, p&lt;0.001) and post-operative ischemic stroke (3.4% vs. 6.1%, p&lt;0.001) occurred less in patients with CLD. Using a multivariate logistic regression model to adjust for confounding factors, revealed that CLD was predictive of increased mortality in patients undergoing LVAD implantation (odds ratio: 1.29, 95% confidence interval [CI]; 1.06 to 1.56, p=0.010). Conclusions: We demonstrated between 2012 to 2017, given the clinical paradox of pro- and anticoagulant risks in patients with CLD and advanced HF, LVAD implantation was associated with increased mortality, major bleeding with increased utilization of platelet products and yet increased thrombotic complications. Further studies are needed to evaluate both thrombotic and bleeding risks in this population, along with mitigating factors without compromising either outcome.

The Impact of Obesity on Left Ventricular Assist Device Outcomes.

Background and Objectives: The understanding of high body mass index (BMI) and outcomes after Left Ventricular Assist Device (LVAD) implantation continues to evolve and the relationship has not been established yet. In this study, we investigated the effects of obesity (BMI > 30 kg/m2) on post–LVAD implantation outcomes. HeartWare LVAD and Heart Mate III LVAD were implanted. The primary outcome that was measured was mortality (in-hospital and on follow-up). The secondary outcomes that were measured were major adverse events. Materials and Methods: At our institution, the West German Heart and Vascular Center (Essen, Germany), from August 2010 to January 2020, a total of 210 patients received a long-term LVAD. Patients were stratified according to BMI ≥ 30 kg/m2 representing the obesity threshold. The first group (n = 162) had an average BMI of 24.2 kg/m2 (±2.9), and the second group (n = 48) had an average BMI of 33.9 kg/m2 (±3.2). Baseline demographics were analysed alongside comorbidities per group. Results: Overall mortality was not significantly different between the obese group (51.1% n = 24) and the nonobese group (55.2%, n = 85) (p = 0.619). The difference between the mean duration of survival of patients who expired after hospital discharge was insignificant (2.1 years ± 1.6, group 1; 2.6 years ± 1.5, group 2; p = 0.29). In-hospital mortality was unvaried between the two groups: group 1: n = 34 (44% out of overall group 1 deaths); group 2: n = 11 (45.8% out of overall group 2 deaths) (p > 0.05). Postoperative complications were unvaried between the obese and the non-obese group (all with p > 0.05). However, a significant difference was found with regards to follow-up neurological complications (18.5% vs. 37.8%, p = 0.01) and LVAD thrombosis (14.7% vs. 33.3%, p = 0.01), as both were higher in the obese population. Conclusion: Obesity does not form a barrier for LVAD implantation in terms of mortality (in-hospital and on follow up). However, a significantly higher incidence of follow-up LVAD thrombosis and neurological complications has been found in the obese group of patients.

Thrombotic Risk of Rotor Speed Modulation Regimes of Contemporary Centrifugal Continuous-flow Left Ventricular Assist Devices

Contemporary centrifugal continuous-flow left ventricular assist devices (LVADs) incorporate dynamic speed modulation algorithms. Hemocompatibility of these periodic unsteady pump operating conditions has been only partially explored. We evaluated whether speed modulation induces flow alterations associated with detrimental prothrombotic effects. For this aim, we evaluated the thrombogenic profile of the HeartWare ventricular assist device (HVAD) Lavare Cycle (LC) and HeartMate3 (HM3) artificial pulse (AP) via comprehensive numerical evaluation of (i) pump washout, (ii) stagnation zones, (iii) shear stress regimens, and (iv) modeling of platelet activation status via the platelet activity state (PAS) model. Data were compared between different simulated operating scenarios, including: (i) constant rotational speed and pump pressure head, used as reference; (ii) unsteady pump pressure head as induced by cardiac pulsatility; and (iii) unsteady rotor speed modulation of the LC (HVAD) and AP (HM3). Our results show that pump washout did not improve across the different simulated scenarios in neither the HVAD nor the HM3. The LC reduced but did not eliminate flow stagnation (-57%) and did not impact metrics of HVAD platelet activation (median PAS: +0.4%). The AP reduced HM3 flow stagnation by up to 91% but increased prothrombotic shear stress and simulated platelet activation (median PAS: +124%). Our study advances understanding of the pathogenesis of LVAD thrombosis, suggesting mechanistic implications of rotor speed modulation. Our data provide rationale criteria for the future design optimization of next generation LVADs to further reduce hemocompatibility-related adverse events.

Evaluating the impact of chronic obstructive pulmonary disease on in‐hospital outcomes following left ventricular assist device implantation

Chronic obstructive pulmonary disease (COPD) is a cause of ventricular dysfunction. However, in the setting of patients with heart failure undergoing left ventricular assist device (LVAD) implantation, there is a paucity of data on the association between COPD and in-hospital outcomes. Retrospective cohort study based on the NIS including patients ≥18 years who underwent LVAD implantation from 2011 to 2017. Multivariate regression was used to evaluate the impact of COPD on in-hospital outcomes. A total of 25,503 patients underwent LVAD implantation, of which 13.8% also had COPD. COPD group was older (median 62 vs. 58 years), and more males (82% vs. 76.4%, p < .001 for both). COPD group had more hypertension, diabetes, atrial tachyarrhythmias, dyslipidemia, prior stroke, coronary artery diseases, pulmonary hypertension, and chronic kidney disease (p < .001 for all). No differences in strokes, infections, mechanical circulatory support, and LVAD thrombosis. There was a higher incident of inpatient acute kidney injury, major bleeding, cardiac complications, thromboembolism, and cardiac arrest in patients without COPD (p < .05 for all). Compared with no-COPD group, COPD group had a lower mortality (6.2% vs. 12.4%; odds ratio, 0.59; confidence interval, 0.512-0.685; p < .05). Patients with COPD undergoing LVAD implantation have more comorbidities, without an associated increase mortality.