Mortality In Left Ventricular Assist Device Patients Research Articles

Abstract 13680: Assessing the Role of Phosphodiesterase-5 Inhibitors in the Management of Left Ventricular Assist Device Patients: A Systematic Review and Meta-Analysis

Introduction: The advent of left ventricular assist device (LVAD) therapy revolutionized the management of severe heart failure. Right ventricular failure (RVF) remains a principal cause of mortality among these patients. Previous reports suggest phosphodiesterase-5 inhibitors (PDE-5is) can decrease pulmonary pressure, enhance ventricular function, and lower the risk of thrombosis and stroke. Nonetheless, certain studies present conflicting data, indicating potential increases in bleeding and mortality among patients using PDE-5is. Hypothesis: This study aimed to assess the outcomes of LVAD patients who were administered PDE-5is. Methods: A comprehensive search of PubMed/Medline, EMBASE, Cochrane, Web of Science, Scopus, and grey literature was conducted until January 2022. We included studies that directly compared outcomes of LVAD patients who used PDE-5is versus those who did not. Primary outcomes focused on postoperative RVF and all-cause mortality, while secondary outcomes included stroke, gastrointestinal bleeding, and pump thrombosis. The statistical analysis was performed using "R" statistical computing software (version 4), utilizing the metafor and meta packages. Results: Eight studies encompassing 3035 PDE-5i users and 3023 non-users were included in our analysis. PDE-5i use was not significantly associated with postoperative RVF (RR: 0.84; 95% CI 0.58-1.21, P=0.35; I2 = 83.2%). Similarly, there was no significant correlation between PDE-5i use and all-cause mortality (RR: 0.99; 95% CI 0.96-1.02, P=0.75; I2 = 0%), pump thrombosis (RR: 0.66; 95% CI 0.61-0.72, P=0.45; I2 = 0%), stroke (RR: 0.96; 95% CI 0.84-1.08, P=0.58; I2 = 0%), or gastrointestinal bleeding (RR: 1.13; 95% CI 0.77-1.67, P=0.65; I2 = 0%). Conclusions: Our analysis suggests that PDE-5i use is not associated with increased adverse outcomes such as bleeding, stroke, thrombosis, or all-cause mortality in LVAD patients. However, given the heterogeneity of the included studies and a lack of robust evidence supporting PDE-5i use, high-quality randomized controlled trials are needed to assess the potential benefits, efficacy, and safety of PDE-5is in reducing RVF, thrombosis, and all-cause mortality in LVAD patients.

Abstract 18204: Application of Machine Learning in Predicting All-Cause Mortality in Patients With Left Ventricular Assist Device

Introduction: Machine learning has been demonstrated to significantly enhance the accuracy of cardiovascular risk prediction across various cardiac diseases. Hypothesis: This study sought to develop a machine learning (ML) framework to predict all-cause mortality in patients with left ventricular assist device (LVAD). Methods: All patients in INTERMACS registry who received an LVAD from June 2006 to December 2017 were screened. The Light Gradient Boosting Machine (LightGBM) algorithm was used to train an ML model for predicting all-cause mortality. Nested ten-fold cross-validation was performed to optimize the model and estimate its performance on unseen data. Model performance was assessed using the receiver operating characteristics (ROC) curves. Results: The final study group consisted of 22,137 patients, with a mean age of 56±13 years, and 21.3% being female. After a median follow-up of 12.4 months (IQR, 4.7 - 27.1 months). The overall all-cause mortality was reported in 7228 patients (32.7%). The proposed LightGBM-based framework had good performance with an area under the receiver operating characteristic curve (AUC-ROC) of 0.74 ± 0.05 on average over the 10 trials. Furthermore, when stratified by gender, the LightGBM-based framework had good performance (AUC-ROC of 0.73 for males and AUC-ROC of 0.70 for females). Conclusions: A ML model using LightGBM can predict all-cause mortality in LVAD patients with good performance.

Abstract 13717: Apixaban vs Warfarin for LVAD Anticoagulation

Introduction: Left ventricular assist devices (LVADs) are a therapy for the management of end stage heart failure. LVADs are typically managed with long-term therapeutic anticoagulation with warfarin to prevent thrombotic complications. Direct oral anticoagulants (DOACs) are easier to manage than warfarin for other medical conditions requiring therapeutic anticoagulation. There is limited data regarding DOAC safety in patients with LVADs. Hypothesis: There is no significant difference in outcomes for patients with LVAD when on DOAC compared to warfarin. Methods: In a single center retrospective analysis from February 2019 to May 2023, patients with LVAD who were switched to the DOAC apixaban (due to warfarin complications or compliance problems) were compared to patients who remained on warfarin. Overall survival, number of hospitalizations, bleeding and thrombotic complications were compared within/between groups. Results: 72 patients were included. DOAC group vs warfarin group: n=12 vs 60, mean age = 52.5 vs 54.2 years; Male 75% vs 81.7%; black 66.7%; vs 58.3%. For DOAC group, 10 out of 12 were on warfarin prior to DOAC. Of these 10, incidence rates for bleeding related admissions were 4.2 per 1000 days on initial warfarin and 0.76 per 1000 days after switching to DOAC. Relative risk reduction of bleeding related admissions decreased by 81.9%. In the DOAC group, thrombosis related admissions on initial warfarin were 0, compared to 1 after switching to DOAC. When comparing DOAC and Warfarin groups, there were no statistically significant difference in bleeding or thrombotic complications (HR = 0.61; 95%CI= 0.21 to 1.46; HR= 0.74; 95%CI= 0.02 to 6.08, respectively) or mortality (HR = 0.44; 95%CI: 0.01 to 3.12). Incidence rates for bleeding related admissions were 0.98 per 1000 days and 1.59 per 1000 days, for DOAC and Warfarin, respectively. Incidence rates for thrombotic related admissions were 0.16 per 1000 days and 0.22 per 1000 days, for DOAC and Warfarin, respectively. Conclusions: There was no statistically significant difference in bleeding, thrombotic events, or mortality in LVAD patients receiving DOAC compared to Warfarin. Switching to DOAC improved bleeding rates in LVAD patients that suffered bleeding complications with Warfarin.

Abstract 15045: Impact of Left Ventricular Assist Device (LVAD) Type on Arrhythmic Outcomes in Patients With Continuous Flow LVADs

Introduction: Cardiac arrhythmias are common in continuous flow left ventricular assist device (LVAD) recipients. The impact of axial vs. intrapericardial centrifugal LVAD pumps on arrhythmia incidence and associated clinical outcomes is unclear. Hypothesis: This multicenter study evaluated the impact of LVAD type (axial vs. centrifugal) on incidence of atrial and ventricular arrhythmias, ICD shocks and mortality in LVAD patients. Methods: Analysis was done on 536 patients who underwent LVAD implantation at 5 US centers from 2008 to 2016. The groups were divided based on their LVAD type (axial - HeartMate II [HMII, n=433] vs. centrifugal - HeartWare (HW, n=103). Baseline characteristics as well as incidence of post-LVAD atrial arrhythmias (PL-AA), ventricular arrhythmias (PL-VA) and ICD shocks were analyzed in these groups. Multivariable Cox Regression analysis was used to identify predictors of survival. Results: Of 536 patients, 433 had HMII axial LVAD and 103 had HW centrifugal VAD implant. At baseline, HMII group had more males, higher proportion of CRT-D and higher prevalence of AA (Table 1A). Left ventricular dimensions were similar between groups. During a median follow-up of 537 days of LVAD support, incidence of PL-VA and ICD shocks were significantly higher in the HM2 group compared to HW group whereas incidence of PL-AA was not significantly different (Table 1A). In multivariable Cox Regression analysis, LVAD indication was the only variable that predicted survival (Table 1B). Type of LVAD (axial vs. centrifugal) was not associated with survival (HMII vs. HW - HR 1.04, P=0.48). Conclusions: In this multi-center continuous flow LVAD cohort, axial HM2 VAD patients had a higher incidence of PL-VA and ICD shocks. Type of LVAD (axial vs. centrifugal) was not associated with survival.

A MULTI-CENTRE STUDY EXAMINING THE ASSOCIATION BETWEEN NATRIURETIC PEPTIDES AND MORTALITY IN PATIENTS WITH A LEFT VENTRICULAR ASSIST DEVICE

BACKGROUND In patients with advanced heart failure, a left ventricular assist device (LVAD) offers improved survival and quality of life. NTproBNP is commonly measured during routine follow-up in patients with a LVAD. While NTproBNP has been extensively studied in ambulatory heart failure patients, and proven a useful prognostic marker, there is scarce evidence on its prognostic utility in LVAD patients. This multi-centre study aims to evaluate the association between NTproBNP and mortality in patients with a LVAD as bridge to heart transplant or destination therapy. METHODS AND RESULTS This is a two-center retrospective cohort study including 165 consecutive adults discharged after implantation of a durable continuous flow LVAD either as bridge to heart transplant, or as destination therapy between 2006 and 2020 at the Toronto General Hospital (Toronto, ON) and the Rigshospitalet (Copenhangen, Denmark). Uni- and multi-variable extended Cox proportional hazard models were used to evaluate the association between multiple measures of NTproBNP and mortality in LVAD patients. Of the 165 patients included in the analysis, 84 patients died and 76 patients were successfully bridged to heart transplant. Multi-variable analysis were adjusted for age, gender, type of cardiomyopathy, hypertension and diabetes. There was an increasing mortality risk with increasing NTproBNP values (Figure), with a significantly increased risk in patients with NTproBNP >1600 pmol/L in comparison to < 400 pmol/L (HR 4.4, CI 2.1-10.0). CONCLUSION Our multi-centre study demonstrates that in patients with a LVAD for bridge to transplantation or destination therapy, NTproBNP values exceeding 1600 pmol/L are significantly associated with increased risk of mortality. Larger studies may be useful to examine the prognostic utility of lower levels of NTproBNP and its association with mortality or heart-failure related hospitalizations. In patients with advanced heart failure, a left ventricular assist device (LVAD) offers improved survival and quality of life. NTproBNP is commonly measured during routine follow-up in patients with a LVAD. While NTproBNP has been extensively studied in ambulatory heart failure patients, and proven a useful prognostic marker, there is scarce evidence on its prognostic utility in LVAD patients. This multi-centre study aims to evaluate the association between NTproBNP and mortality in patients with a LVAD as bridge to heart transplant or destination therapy. This is a two-center retrospective cohort study including 165 consecutive adults discharged after implantation of a durable continuous flow LVAD either as bridge to heart transplant, or as destination therapy between 2006 and 2020 at the Toronto General Hospital (Toronto, ON) and the Rigshospitalet (Copenhangen, Denmark). Uni- and multi-variable extended Cox proportional hazard models were used to evaluate the association between multiple measures of NTproBNP and mortality in LVAD patients. Of the 165 patients included in the analysis, 84 patients died and 76 patients were successfully bridged to heart transplant. Multi-variable analysis were adjusted for age, gender, type of cardiomyopathy, hypertension and diabetes. There was an increasing mortality risk with increasing NTproBNP values (Figure), with a significantly increased risk in patients with NTproBNP >1600 pmol/L in comparison to < 400 pmol/L (HR 4.4, CI 2.1-10.0). Our multi-centre study demonstrates that in patients with a LVAD for bridge to transplantation or destination therapy, NTproBNP values exceeding 1600 pmol/L are significantly associated with increased risk of mortality. Larger studies may be useful to examine the prognostic utility of lower levels of NTproBNP and its association with mortality or heart-failure related hospitalizations.

Impact of COVID-19 on Patients Supported with a Left Ventricular Assist Device.

Patients on left ventricular assist device (LVAD) support may be susceptible to severe disease and complications from coronavirus disease-19 (COVID-19). The purpose of this study was to describe the clinical course of COVID-19 in LVAD patients. A retrospective review was performed at our center; 28 LVAD patients who developed COVID-19 between March 2020 and March 2021, and six patients with a prior COVID-19 infection who underwent LVAD implantation, were identified and examined. Of the 28 patients, nine (32%) died during the study period, five (18%) during their index hospitalization for COVID-19. Two patients (7%) presented with suspected pump thrombosis. In a nonadjusted binary regression logistic analysis, admission to the intensive care unit (unadjusted odds ratio, 7.6 [CI, 1.2-48], P = 0.03), and the need for mechanical ventilation (unadjusted odds ratio 14 [CI, 1.3-159], P = 0.03) were associated with mortality. The six patients who previously had COVID-19 and subsequently received a LVAD were on intra-aortic balloon pump and inotropic support at time of surgery. All six experienced a complicated and prolonged postoperative course. Three patients (50%) suffered from ischemic stroke, and there was one (17%) 30 day mortality. We observed an increased risk of morbidity and mortality in LVAD patients with COVID-19.

A Comprehensive Review of Risk Factor, Mechanism, and Management of Left Ventricular Assist Device-Associated Stroke.

The use of left ventricular assist devices (LVADs) has been increasing in the last decade, along with the number of patients with advanced heart failure refractory to medical therapy. Ischemic stroke and intracranial hemorrhage remain the leading causes of morbidity and mortality in LVAD patients. Despite the common occurrence and the significant outcome impact, underlying mechanisms and management strategies of stroke in LVAD patients are controversial. In this article, we review our current knowledge on pathophysiology and risk factors of LVAD-associated stroke, outline the diagnostic approach, and discuss treatment strategies.

Seasonal Variation in Epistaxis Recurrence and Mortality in Left Ventricular Assist Device Patients

<h3>Purpose</h3> Studies have shown seasonal variation in the incidence of epistaxis. However, this trend has not been evaluated in patients with left ventricular assist device (LVADs), who are at an increased risk for this frequent adverse event. We assessed the seasonality of epistaxis recurrence and its impact on mortality in LVAD patients. <h3>Methods</h3> We retrospectively reviewed 103 patients undergoing LVAD implantation from 2015-2020. Univariate and multivariate binary logistic regression analyses were used to evaluate predictors for mortality. <h3>Results</h3> 33 (32%) patients developed epistaxis; of these patients, 25 (75%) had recurrent events. The median time to event was 27 (10, 225) days post-implantation, and 67% of events occurred within 3 months. Fall and winter were the seasons with the most events (36% and 33%, respectively), while spring and summer had comparatively fewer events (18% and 12%, respectively). Patients with epistaxis in winter were most likely to have a recurrence (91%), followed by spring, summer, and fall (83%, 75%, and 58%, respectively). Winter implantation (OR 9.5; 95% CI 1.7-78.14) and age ≥ 58 years (OR 14.88; 95% CI 2.15-303.8) were significantly associated with mortality in LVAD patients with epistaxis (<i>P</i> <0.05 for both). These risk factors were independent predictors of mortality in multivariate analysis (Winter implant: OR 10.34; 95% CI 1.44-120; <i>P</i> = 0.03 and Age ≥ 58 years: OR 16.1; 95% CI 1.89-386; <i>P</i> = 0.03). <h3>Conclusion</h3> We found that the fall and winter seasons had an increased number of epistaxis events, which is consistent with the results of studies conducted in non-LVAD patient populations. Older patients with epistaxis are at an increased risk for mortality. Furthermore, the effect of winter implantation on mortality in epistaxis patients warrants further investigation. Larger, prospective studies should be done to validate these findings.

Right Ventricular Arterial Elastance is Associated with Prognostic Value in one Year Mortality Following Left Ventricular Assist Device Placement

Background In patients with end-stage heart failure (HF), acute right heart failure (RHF) after left ventricular assist device (LVAD) implantation is known to be a source of significant morbidity and mortality. Previous data identified RV pulsatility load using pulmonary arterial compliance as a marker for 6-month mortality in LVAD patients. We aimed to test whether the right ventricular arterial elastance (RVEa) was associated with increased risk of 1 year mortality after LVAD implantation. Hypothesis Patients with higher RVEa at preimplantation have a higher risk of dying at 1 year. Methods We retrospectively identified 381 patients with complete pre-implant hemodynamics obtained Results The majority of patients (65%) had RVEa≥1 (Fig. 1). When comparing baseline demographics, those with RVEa ≥1 were younger, had a lower proportion of hypertension, coronary artery disease, and more likely to be on inotropes pre-implantation. Those with RVEa ≥1 had lower SV, and pulmonary artery pressure index; and higher mean pulmonary artery pressure, pulmonary wedge capillary pressure and transpulmonary gradient. Multivariate survival analysis adjusted for heart rate, BMI, age, and gender demonstrated the only independent predictor of mortality was RVEa ≥1 (hazard ratio 1.80, [95% CI 1.07 - 3.05], p= 0.028). Conclusions Our multi-institutional study demonstrates that higher RVEa is associated with increased 1 year mortality post-VAD implantation. These data may be generalizable to other academic institutions and warrants further investigation in larger cohorts.

Clinical Impact of Hematoma Expansion in Left Ventricular Assist Device Patients

Hematoma expansion (HE) is associated with poor outcome in patients with intracerebral hemorrhage (ICH), but the impact on patients with an left ventricular assist device (LVAD) is unknown. We aimed to define the occurrence of HE in the LVAD population and to determine the association between HE and mortality. We performed a retrospective cohort study of LVAD patients and intentionally matched anticoagulated controls without LVAD admitted to Columbia University Irving Medical Center with ICH between 2008 and 2019. We compared HE occurrence between patients with an LVAD and those without an LVAD using regression modeling, adjusting for factors known to influence HE. We evaluated pump thrombosis following anticoagulation reversal. We examined the association between HE and hospital mortality using Poisson regression modeling adjusting for factors associated with poor outcome. Among 605 patients with an LVAD, we identified 28 patients with ICH meeting the study's inclusion criteria. Our LVAD ICH cohort was predominantly male (71%), with a mean age of 56 ± 10 years. The median baseline hematoma size was 20.1 mL3 (interquartile range [IQR], 8.6-46.9 mL3), and the median ICH score was 1 (IQR, 1-2). There was no significant difference in occurrence of HE in LVAD patients and matched non-LVAD patients (adjusted odds ratio [OR], 1.3; 95% confidence interval [CI], 0.4-4.2). There was an association between HE and in-hospital mortality in LVAD patients (adjusted OR, 4.8; 95% CI, 1.4-6.2). HE occurrence appears to be similar in LVAD and non-LVAD patients. HE has a significant impact on LVAD ICH mortality, underscoring the importance of adequate coagulopathy reversal and blood pressure management in these patients.

Pharmacological Treatment of Pump-Related Thrombosis in Patients with Left Ventricular Assist Device (HearWare HVAD)

Left ventricular assist device (LVAD) is one of the stablished treatments for advanced heart failure. Pump thrombosis (PT) is a major complication, increasing morbidity and mortality in LVAD patients. PT management includes surgical and pharmacological measures but the optimal treatment is not well defined. For this purpose, we reviewed our experience. From June 2011 to July 2019, 85 patients were implanted with a third generation LVAD (HeartWare HVAD, Medtronic, Inc.). All patients were implanted as a Bridge to Transplantation (BTT). PT was considered using INTERMACS criteria. Pharmacological treatment was defined by the use of intravenous heparin alone or in association with systemic thrombolysis with tissue plasminogen activator, t-PA-Actiliyse or with left intraventricular thrombolysis with t-PA-Actilyse. Success of the treatment was defined as improvement on biological and/or LVAD parameters, no surgical pump exchange and survival at 30 days. Treatment complications were defined as ischemic or hemorrhagicstroke or fatal bleeding. There were 47 pump thrombosis in 15 patients (18.3%, 12 men) for a total event rate of 3.1 thrombosis/patient. The mean time for all thrombotic event was 100.2±134.23 months and mean time for the first thrombotic event for heparin alone, local fibrinolysis and systemic fibrinolysis was 85.7, 40.1 and 174.8 months respectively.Thirteen thrombotic events were treated with systemic heparin alone, 26 were treated with systemic thrombolysis and 8 were treated with left intraventricular thrombolysis. Pharmacological treatment was successful in 13 patients, two patients died (intraventricular thrombolysis): one from stroke hemorrhage and one from abdominal hemorrhage. 12 patients were successfully transplanted. One patient is still alive with the LVAD. The mean waiting time on the transplant list was 35.3±18.1 months after PT. The 30 days survival is not statistically significant between the different pharmacological treatments for pump thrombosis. LVAD thrombosis is a major complication after LVAD implantation. Pharmacological conservative treatment with heparin or fibrinolysis could be the first line treatment before considering pump exchange or urgent heart transplant.

Abstract TP334: Clinical Impact of Hematoma Expansion in LVAD Patients

Background: Intracerebral hemorrhage (ICH) in left ventricular assist device (LVAD) patients is a devastating complication. Hematoma expansion (HE) is associated with poor outcomes in ICH patients, but the impact of HE on LVAD patients is not known. Prevention of HE includes rapid and complete coagulopathy reversal, adding further potential complications in LVAD patients given the inherent risk of hardware thrombosis. We aimed to define the occurrence of HE in the LVAD population and to determine the association between HE and mortality in this population. Methods: We performed a retrospective cohort study of ICH patients with preceding LVAD implantation admitted to Columbia University Irving Medical Center between Jan 2008 and April 2019. Intentionally matched ICH controls without LVADs were identified to compare rate of HE in LVAD and non LVAD patients. ICH volume was measured using ABC/2 method.We defined HE as an increase in hematoma volume of 6 ml or 33% comparing the first and last scan in 24 hours. Demographic data was compared using Pearson’s χ2 test for categorical variables and students T test and Wilcoxon rank sum test for normal and non-parametric continuous variables. The association between HE and hospital mortality in LVAD patients was examined using regression modeling after adjusting for Glasgow coma scale, age, hematoma size and location and admission INR. Results: Of605 LVAD patients, we identified 40 patients with ICH. Of these, 28 patients met the inclusion criteria. Mean (SD) age of LVAD patients was 56 (10), 29% of patients were female and the majority (81%) of LVAD patients were supported by Heartmate II. The median (interquartile range [IQR]) baseline hematoma size was 20.1 ml (8.6-46.9), median (IQR) ICH score was 1 (1-2). HE occurred in 16 (57%) patients supported by LVAD, and in 50% of patients without LVAD with no difference (p=0.6).There was an association between HE and in-hospital mortality in LVAD patients after adjusting for admission ICH score and INR (OR of 20.5, 95% CI: 1.8-232.8). Conclusions: HE is a potentially modifiable risk factor for mortality. We demonstrate that LVAD patients experience HE at a similar rate to matched controls. We show that prevention of HE with anticoagulation reversal does not increase mortality.

The Role of Ventricular Tachycardia in LVAD Patients and Clinical Outcomes

Introduction Ventricular tachycardia (VT) is common in patients with end-stage heart failure, and pose additional risks in patients who have left ventricular assist devices (LVAD). We set out to examine if development of VT increases risk of mortality post-LVAD and the odds of developing right ventricular failure (RVF). Hypothesis New onset VT increases both the risk of 1-year mortality post-LVAD and the odds of developing RVF. Methods We performed a single-center retrospective analysis of 295 patients who received a continuous-flow durable LVAD (HeartMate II or HeartWare VAD) between Jan. 1st 2006 through Dec. 31st 2016. We stratified patients to 2 cohorts: those who had positive or negative history of VT pre-LVAD and those who developed VT post-LVAD. A survival analysis based on 1-year survival was performed to find predictors of mortality and association with RVF. RVF severity was defined according to the new INTERMACS criteria. Results In patients with and without a history of VT, 113 (67%) and 74 (58%) respectively developed VT post-LVAD. Baseline characteristics were similar among all cohorts (Table 1). Survival analysis demonstrated that both new onset VT (Figure 1) and recurrence of VT did not increase the risk of 1 year mortality post-LVAD. Additionally, univariable analysis in patients without history of VT pre-LVAD showed that VT increased the odds of developing severe RVF (Table 2) (OR 6.20, p=0.020, 95%CI [1.33 - 29.0]), but this was no longer significant in multivariable analysis. Conclusions New onset and recurrent VT do not appear to be associated with increased mortality in LVAD patients. While there is a signal that new onset VT may increase the odds of severe RVF in patients without VT history pre-LVAD, this needs to be addressed prospectively and in larger cohorts.

Hyponatremia is Associated with Poor Prognosis in Left Ventricular Assist Device Patients

IntroductionSerum sodium is an important prognostic marker in heart failure patients, with lower values associated with increased risk of mortality. However, prognostic value of serum sodium has not been assessed in left ventricular assist device (LVAD) patients.HypothesisWe hypothesized lower serum sodium is associated with increased risk of mortality in LVAD patients.MethodsWe retrospectively identified 253 consecutive patients that had LVAD implantation at a single center between 2008-2016. To minimize confounding by peri-operative factors, we evaluated serum sodium at 3 months after implantation and time to all-cause mortality with a univariate Cox proportional hazards analysis. A secondary outcome was time to hospital readmission. Groups were defined as having lower and higher sodium levels relative to the median value. Censoring occurred at death, transplant, or pump exchange. A multivariate Cox proportional hazards analysis included estimated GFR and bicarbonate levels to account for effects of renal dysfunction and acid-base disturbance on sodium levels.ResultsThere were 195 eligible LVAD patients with a sodium value at 3 months. Average age was 53 ± 14 yrs, 77% were male, 26% black. Half (50%) received a Heartmate II device and 50% received a Heartware HVAD. Median serum sodium was 137 mmol/L. Median follow-up was 346 days with 26 deaths (13%). In a univariate analysis, increasing serum sodium at 3 months was associated with a lower risk of all-cause mortality (HR 0.826, p=0.006). Pre-operative sodium levels were not associated with mortality (HR 1.004, p=0.941). Serum sodium at 3 months remained predictive of mortality in a multivariate model with estimated GFR and HCO3 (Table). When stratified by the median, the lower sodium group had a significantly shorter time to all-cause mortality (Figure). Sodium levels at 3 months were not associated with time to readmission.ConclusionsHyponatremia in LVAD patients (sodium <137 mmol/L) is associated with significantly higher risk of all-cause mortality. Whether hyponatremia in an LVAD patient represents ongoing neurohormonal activation due to heart failure or is due to other etiologies associated with increased risk needs to be elucidated. Serum sodium is an important prognostic marker in heart failure patients, with lower values associated with increased risk of mortality. However, prognostic value of serum sodium has not been assessed in left ventricular assist device (LVAD) patients. We hypothesized lower serum sodium is associated with increased risk of mortality in LVAD patients. We retrospectively identified 253 consecutive patients that had LVAD implantation at a single center between 2008-2016. To minimize confounding by peri-operative factors, we evaluated serum sodium at 3 months after implantation and time to all-cause mortality with a univariate Cox proportional hazards analysis. A secondary outcome was time to hospital readmission. Groups were defined as having lower and higher sodium levels relative to the median value. Censoring occurred at death, transplant, or pump exchange. A multivariate Cox proportional hazards analysis included estimated GFR and bicarbonate levels to account for effects of renal dysfunction and acid-base disturbance on sodium levels. There were 195 eligible LVAD patients with a sodium value at 3 months. Average age was 53 ± 14 yrs, 77% were male, 26% black. Half (50%) received a Heartmate II device and 50% received a Heartware HVAD. Median serum sodium was 137 mmol/L. Median follow-up was 346 days with 26 deaths (13%). In a univariate analysis, increasing serum sodium at 3 months was associated with a lower risk of all-cause mortality (HR 0.826, p=0.006). Pre-operative sodium levels were not associated with mortality (HR 1.004, p=0.941). Serum sodium at 3 months remained predictive of mortality in a multivariate model with estimated GFR and HCO3 (Table). When stratified by the median, the lower sodium group had a significantly shorter time to all-cause mortality (Figure). Sodium levels at 3 months were not associated with time to readmission. Hyponatremia in LVAD patients (sodium <137 mmol/L) is associated with significantly higher risk of all-cause mortality. Whether hyponatremia in an LVAD patient represents ongoing neurohormonal activation due to heart failure or is due to other etiologies associated with increased risk needs to be elucidated.

Left Ventricular Assist Device Infections: A Systematic Review.

Left ventricular assist devices (LVADs) are becoming a more frequent life-support intervention. Gaining an understanding of risk factors for infection and management strategies is important for treating these patients. We conducted a systematic review and meta-analysis of studies describing infections in continuous-flow LVADs. We evaluated incidence, risk factors, associated microorganisms, and outcomes by type of device and patient characteristics. Our search identified 90 distinct studies that reported LVAD infections and outcomes. Younger age and higher body mass index were associated with higher rates of LVAD infections. Driveline infections were the most common infection reported and the easiest to treat with fewest long-term consequences. Bloodstream infections were not reported as often, but they were associated with stroke and mortality. Treatment strategies varied and did not show a consistent best approach. LVAD infections are a significant cause of morbidity and mortality in LVAD patients. Most research comes from secondary analyses of other LVAD studies. The lack of infection-oriented research leaves several areas understudied. In particular, bloodstream infections in this population merit further research. Providers need more research studies to make evidence-based decisions about the prevention and treatment of LVAD infections.

Trends, predictors and outcomes of ischemic stroke and intracranial hemorrhage in patients with a left ventricular assist device.

Patients with a left ventricular assist device (LVAD) are at a higher risk of ischemic stroke (IS) and intracranial hemorrhage (ICH). There is limited data available on risk factors and outcomes associated with IS and ICH in LVAD patients. All patients >18 years of age with an LVAD were identified based on the U.S. Nationwide Inpatient Sample (NIS) database from the year 2007 to 2011. Patients with a discharge diagnosis of IS were compared to those without IS. In a separate analysis, patients with a discharge diagnosis of ICH were compared to patients without ICH. Trends, predictors and outcomes of IS and ICH were analyzed using a multivariate regression model. Out of 17,323 discharges with a primary diagnosis of heart failure with LVAD, 624 (3.6%) patients had a co-diagnosis of IS and 387 (2.2%) had a co-diagnosis of ICH. From 2007 to 2011, the discharge diagnosis of heart failure with LVAD increased from 946 to 5,540, but the proportion of patients with IS remained about 3.4%, while the incidence of ICH decreased from 3.8% in 2007 to a plateau of around 2.2% in the following years. After adjusting for potential confounders, increasing Charlson Comorbidity Index (CCI) score was an independent predictor of IS and ICH. In-hospital mortality was four-fold higher in the IS group (odds ratio: 4.2; 95% CI: 2.3-7.6; P<0.0001) and 18-fold higher in the ICH group (OR: 18; 95% CI: 9-34, P<0.0001). Renal disease (OR: 5.3; CI: 1.3-22.1; P=0.02), liver disease (OR: 4.9; CI: 1.1-21.2; P=0.03) and abnormal coagulation profile (OR: 4.8; CI: 1.6-14.4; P=0.01) were independent predictors of mortality in LVAD patients with IS. Presence of diabetes mellitus (OR 4.3, P=0.1) and liver disease (or 2.8, P=0.2) showed trends towards predicting mortality in LVAD patients with ICH but did not reach statistical significance. Increasing comorbidity burden significantly increases the risk of both IS and ICH with LVAD. In our cohort, the incidence of IS and ICH increases the mortality 4- and 18-fold, respectively. Renal disease, liver disease and abnormal coagulation profile were independent predictors of mortality in LVAD patients with IS.

Predictors of ventricular arrhythmia after left ventricular assist device implantation: A large single-center observational study

Ventricular arrhythmias (VAs) are common in patients after left ventricular assist device (LVAD) implantation. The purpose of this study was to determine the predictors of VAs and their impact on mortality in LVAD patients. A total of 98 consecutive patients with an implantable cardioverter-defibrillator (ICD) (86 [88%] male, mean age 57 ± 10 years), 57 [58%] with nonischemic dilated cardiomyopathy) who had received an LVAD between May 2011 and December 2013 at our institution were included in the study. Mean left ventricular ejection fraction and left ventricular end-diastolic diameter were 20% ± 8% and 73 ± 11 mm, respectively. Seventy-three patients (75%) had atrial fibrillation (AF). During the 12 months before LVAD implantation, 38 patients (39%) had experienced ≥1 episode of VAs (11.5 ± 20) requiring ICD therapies. The number of patients with VAs was comparable among all types of ICDs (P = .48). During the 12-month follow-up after LVAD implantation, 48 patients (49%) experienced ≥1 episode of VAs (30 ± 98) with appropriate ICD therapies. The prevalence of VAs was significantly higher among patients with pre-LVAD VAs compared to those without VAs during the year before LVAD implantation (66% vs 38%; P = .008). In a binary multiple logistic regression analysis, pre-LVAD VAs (hazard ratio 5.36, 95% confidence interval 2.0-14.3; P = .001) and AF (hazard ratio 3.1, 95% confidence interval 1.1-11.9; P = .024) predicted post-LVAD VAs. Pre-LVAD VAs and AF predict the occurrence of VAs after LVAD implantation. According to the latest data on the negative impact of post-LVAD VAs on all-cause mortality, further studies should clarify the reasonability of maintaining sinus rhythm in patients with AF and/or prophylactic catheter ablation of ventricular tachycardias before LVAD implantation.

Implantable Cardioverter-Defibrillator Use in Patients With Left Ventricular Assist Devices: A Systematic Review and Meta-Analysis

ObjectivesThis study evaluated the impact of implantable cardioverter-defibrillators (ICDs) on mortality in patients with left ventricular assist devices (LVADs) by conducting a systematic review and meta-analysis of published studies. BackgroundThe burden of ventricular arrhythmias in patients with LVADs is high. Prior studies assessing the impact of ICD on survival of patients with LVADs have yielded conflicting results. MethodsRelevant studies from January 2000 through October 2015 were identified in the databases PubMed and OVID. Weighted relative risks were estimated using random effects meta-analysis techniques. ResultsSix observational studies (n = 937) were included. Patients were 53 ± 12 years of age, and 80% were male. Bridge-to-transplantation was the indication for LVAD use in 93% of the patients. A continuous-flow (CF) LVAD was present in 39% of patients. Mean left ventricular ejection fraction was 16 ± 6%. An ICD was present in 355 patients (38%). During a mean follow-up of 7 months, 241 patients (26%) died (16% in the ICD group vs. 32% in the no-ICD group). Presence of an ICD was associated with a 39% relative risk reduction in all-cause mortality (RR: 0.61; 95% confidence interval [CI]: 0.46 to 0.82; p < 0.01). Among subgroup of patients with CF-LVAD (n = 361), ICD use was associated with a statistically nonsignificant trend toward improved survival (RR: 0.76; 95% CI: 0.51 to 1.12; p = 0.17). ConclusionsICD use was associated with a significant reduction in mortality in LVAD patients, however, this effect was not significant in patients with CF-LVADs. Although these data support the use of ICDs, larger randomized trial data are strongly warranted to evaluate ICD effectiveness in patients with current generation LVADs.

Pre-operative Speckle-tracking Imaging to Predict the Need for Right Ventricular Support in Patients Undergoing Left Ventricular Assist Device Implantation

Background: Right ventricular (RV) dysfunction after left ventricular assist device (LVAD) implantation significantly complicates post-device management and has been shown to be associated with increased mortality. Pre-operative identification of patients who may develop post-LVAD RV dysfunction is challenging. This study was designed to evaluate pre-operative echocardiographic speckle tracking imaging as a predictor of post operative RV dysfunction. Methods: Thirty-nine patients who underwent Heartmate II LVAD placement in a single center were studied. Pre- and post-operative clinical, hemodynamic, laboratory, and echocardiographic data were prospectively collected as part of an ongoing institutional LVAD database. RV strain parameters were measured retrospectively using off-line speckletracking analysis software. Results: Twenty five of 39 LVAD recipients developed acute RV failure during the early post-operative period. RV function in 14 of these recipients improved with inotropes and judicious adjustment of LVAD parameters. Eleven patients, however, expired despite aggressive medical therapy including 7 patients who underwent placement of an RVAD. These 11 individuals were identified as having significantly lower global RV strain prior to device placement (p Conclusion: Poor intrinsic RV myocardial function is associated with a higher mortality in LVAD patients. Speckle-tracking echocardiography imaging, particularly, peak systolic global RV strain appears to be promising in predicting LVAD patients who require RVAD. Key words: Echocardiography, Heart Failure, Right heart function, Strain, Ventricular assist device.

Abstract 12518: Ventricular Arrhythmias and Mortality After Left Ventricular Assist Devices Implantation: A Meta-Analysis

Background: Ventricular arrhythmias (VAs) are among the most commonly reported adverse effects associated with left ventricular assist devices (LVADs). However, prevalence of VAs post-LVAD implantation, and their relation to all-cause mortality, remains to be elucidated. We conducted a meta-analysis and systematic review of observational studies with the primary objective of evaluating the risk of VAs after LVAD implantation and the risk of all-cause mortality in patients with LVADs who had VAs. Methods: We searched Medline, Embase and Cochrane Central from 2001 to 2014. Two reviewers independently searched,selected and assessed quality of included studies with differences resolved by consensus. Data were collected and analyzed using random and fixed-effect model, as appropriate, with inverse variance weighting. Results: Of 2,393 studies identified, 15 observational studies were eligible including 1,517 patients with a mean follow up of 201 days. An LVAD was associated with an increased risk of VA after implantation (OR = 2.21, 95% confidence interval [CI] 1.37-3.59, p&lt;0.001).There was an increased risk of all-cause mortality in LVAD patients who had post-LVAD VA (OR = 1.91, 95% CI 1.18-3.11, p&lt;0.001). Using meta-regression and sensitivity analyses to account for risk factors such as etiology of cardiomyopathy, duration of follow-up, destination LVAD versus bridge therapy and presence of an implantable cardioverter defibrillator at time of LVAD implantation did not change the results of our main analysis. Conclusions: LVADs are associated with an increased risk of VA and presence of VAs post LVAD implantation is associated with increased risk of all-cause mortality.