Axillary Impella devices are increasingly employed for long-term support of patients with systolic heart failure and shock. Axillary access allows for awake support and ambulation, which carries an inherent risk of disconnection or malposition. We report a series of two cases where device replacement due to dysfunction and malposition can be completed safely through the original axillary graft using axillary graft thrombectomy, given that the clot burden could be a major source of morbidity to the patient.
Abstract WP403: Trends and Predictors of Intracranial Hemorrhage in Patients With Advanced Heart Failure on Left Ventricular Assist Device From 2005 to 2014 in the U.S.
Introduction: Left ventricular assist device (LVAD) is known to extend survival in patients with advanced heart failure but it is associated with intracranial cranial hemorrhage (ICH). In the last decade, the use of LVAD substantially increased along with advances in LVAD technology, but there is limited data regarding the trends of ICH risk and predictors in patients with LVAD. Methods: We included the patients aged≥18 years with primary diagnosis of LVAD hospitalized in the US from 2005 to 2014 using the National Inpatient Sample. We computed the survey weighted percentages with ICH across the 10-year study period and assessed whether the proportions changed over time. Predictors of ICH were evaluated using the multivariable logistic regression model. All analyses were appropriately adjusted for the survey design variables to account for the complex survey design. Results: Of 33,246 hospitalizations, 568 (1.7%) had ICH. The number of LVAD placement has increased from 873 in year 2005 to 5,175 in year 2014. However, the risk of ICH remained largely unchanged from 1.7% to 2.3% (linear trend: p=0.604). The adjusted odds of ICH was increased with the presence one of the following variables: female sex (odds ratio [OR]: 1.58, 95% confidence interval [CI] 1.03-2.43), history of ischemic stroke (OR: 3.13, 95% CI 1.86-5.28), and Charlson Comorbidity Index (CCI) of ≥3 (OR: 77.40, 95% CI 10.03-597.60). Conclusions: Despite advances in LVAD technology and its increased use in patients with advanced heart failure, the risk of ICH has remained relatively unchanged. High CCI and history of ischemic stroke were associated with higher odds of ICH in patients with LVAD. With the advent of magnetically levitated centrifugal-flow LVAD, future trend of ICH may change and further research efforts are needed to prevent ICH in patients with LVAD.
Left ventricular assist devices in the elderly: Marching forward with cautions
Congestive heart failure is highly prevalent in the elderly population and left ventricular assist device has been increasingly used in this population. LVAD therapy is more costly than medical treatment but it increases the survival and quality of life of the elderly patients with low disease acuity. Therefore careful selection of candidates and implementation of LVAD therapy earlier in the course of the disease is crucial to improve outcomes. With the technical advances and improvement in clinical management, the financial burden of LVAD therapy in the elderly will become less, making this therapy more economically feasible.
OUTCOMES OF NON-LIVER SOLID ORGAN TRANSPLANTATION USING HEPATITIS C POSITIVE DONORS TO HEPATITIS C NEGATIVE RECIPIENTS: A MULTICENTER EXPERIENCE
Patients are admitted to the hospital for hemodynamic optimization before left ventricular assist device (LVAD) implantation. The aim of this study was to evaluate the clinical outcomes of hemodynamic optimization using an intra-aortic balloon pump (IABP) in ambulatory heart failure patients before LVAD placement. This retrospective single-center study included 199 noninotrope-dependent patients who underwent durable LVAD implantation between January 1, 2007 and April 10, 2017. Invasive hemodynamic as well as the primary composite end-point of stage 2 or 3 acute kidney injury, right ventricular failure, and 30-day mortality were compared between patients with and without an IABP. Median age was 64 (interquartile range [IQR], 57–71) years and 165 (82.9%) were male; 72 (36.2%) received an IABP. Patients treated with an IABP had worse baseline exercise capacity and hemodynamic parameters. Patients with an IABP had greater relative reduction in pulmonary artery mean pressure (−16% vs. −2%; p ≤ 0.001). The primary composite end-point was not different between patients who had an IABP and those who did not (20.8% vs. 20.5%; p = 0.952), as were each of the individual end-points. Despite worse baseline hemodynamic parameters and exercise capacity, ambulatory heart failure patients who received an IABP before LVAD implantation had more favorable reductions in pulmonary artery pressures without an increase in the composite end-point. These results suggest that IABP use before LVAD implantation may mitigate the risk of postoperative complications in ambulatory patients.
A Comparison of Von Willebrand Factor Indexes in Heartmate II Compared to Heartware Left Ventricular Assist Devices
Abstract Background: Von Willebrand factor (VWF) is a multimeric glycoprotein synthesized in endothelium and megakaryocytes. Elevated total VWF antigen has been associated with arterial thrombosis, while in patients with left ventricular assist devices (LVAD), loss of high molecular weight multimers is associated with spontaneous bleeding. We hypothesized that the lower rotational speed of the Heartware LVAD would be associated with less severe disruption of VWF. Methods: A total of 22 patients were included. We compared samples from a) 17 patients with Heartmate II LVAD (HM II), 76% male, median age 67 (54-73) years, 24% non-white, 45 (33-59) months after implant, with b) 5 patients with Heartware (HW) LVAD, all male, age 64 (59-65) years, 20% non-white, 27 (14-29) months after implant. All patients received warfarin. All HW patients took aspirin, while 82% of HM II patients took aspirin. Samples were analyzed for VWF antigen, activity, platelet function analyzer-100 collagen adenosine diphosphate closure time (PFA) and VWF multimers by gel electrophoresis. Multimers were assessed qualitatively and quantitatively by dividing mers > 15 by mers 2-15 (multimer ratio) and with a normalized multimer ratio (multimer ratio of patient / normal plasma control from the same gel). Results: Although flow rates did not differ significantly between HM II and HW, 5.2 (4.6-6.5) versus 4.3 (4.2-5.4) liters per minute respectively, rotational speeds were very different, mean 9472 versus 2680 rpms, p<0.0001). There were no differences in hemoglobin, hematocrit, or platelet count at the time of sampling. Qualitative VWF multimers were abnormal in all patients, and PFA was non-clotting in 88% of HM II patients and 80% of HW patients. VWF activity to antigen ratio was not different: HM II 0.68 (0.63-0.74) versus HW 0.70 (0.63-0.71). However, VWF antigen was significantly higher in HM II patients, 199 (174-227) compared to HW, 139 (122-160), p=0.039 and the normalized VWF multimer ratio was significantly lower, suggesting greater loss of high molecular weight multimers in HM II, 0.43 (0.41-0.48) compared to HW, 0.53 (0.48-0.56), p=0.0025 (figure). Conclusion: The lower rotational speed associated with the Heartware LVAD appears to produce less elevation of VWF antigen, and slightly less loss of VWF high molecular weight multimers compared to the Heartmate II LVAD. Additional studies are needed to describe whether or not lower pump thrombosis rates and rates of spontaneous bleeding are associated with these differences. Figure 1. Figure 1. Disclosures No relevant conflicts of interest to declare.
Extracorporeal membrane oxygenation as a salvage therapy for patients with severe primary graft dysfunction after heart transplant
AbstractBackgroundSevere primary graft dysfunction (PGD) is the leading cause of early death after heart transplant.AimTo examine the outcomes of heart transplant recipients who received venoarterial extracorporeal membrane oxygenation (VA‐ECMO) for severe PGD.MethodsWe reviewed electronic health records of adult patients who underwent heart transplant from November 2005 through June 2015. We defined severe PGD according to International Society for Heart and Lung Transplantation consensus statements.ResultsOf 1030 heart transplant patients, 31 (3%) had severe PGD and required VA‐ECMO. The mean (range) age was 59 (43‐69) years. Fifteen patients (48%) underwent prior sternotomy and 10 (32%) received a left ventricular assist device as a bridge to transplant. Severe PGD manifested as failure to wean from cardiopulmonary bypass in 20 patients (65%) and as severe hemodynamic instability in the immediate postoperative period in 10 (32%), including cardiac arrest in 3 (10%). Twenty‐five patients (81%) were successfully weaned from VA‐ECMO, and 19 (61%) were discharged; the other 12 (39%) died.ConclusionsAlthough VA‐ECMO is a common method for providing mechanical circulatory support to patients with PGD, multicenter studies are needed to assess factors associated with successful outcomes and improved survival of these patients.
A Phase 2A Dose-Escalation Study of the Safety, Tolerability, Pharmacokinetics and Haemodynamic Effects of BMS-986231 in Hospitalized Patients with Heart Failure with Reduced Ejection Fraction
Abstract Aims This study was designed to evaluate the safety, tolerability and haemodynamic effects of BMS-986231, a novel second-generation nitroxyl donor with potential inotropic, lusitropic and vasodilatory effects in patients hospitalized with decompensated heart failure and reduced ejection fraction (HFrEF). Methods and results Forty-six patients hospitalized with decompensated HFrEF were enrolled into four sequential dose-escalation cohorts in this double-blind, randomized, placebo-controlled Phase 2a study. Patients with baseline pulmonary capillary wedge pressure (PCWP) of ≥20 mmHg and a cardiac index of ≤2.5 L/min/m2 received one 6-h i.v. infusion of BMS-986231 (at 3, 5, 7 or 12 µg/kg/min) or placebo. BMS-986231 produced rapid and sustained reductions in PCWP, as well as consistent reductions in time-averaged pulmonary arterial systolic pressure, pulmonary arterial diastolic pressure and right atrial pressure. BMS-986231 increased non-invasively measured time-averaged stroke volume index, cardiac index and cardiac power index values, and decreased total peripheral vascular resistance. There was no evidence of increased heart rate, drug-related arrhythmia or symptomatic hypotension with BMS-986231. Analyses of adverse events throughout the 30-day follow-up did not identify any toxicities specific to BMS-986231, with the potential exception of infrequent mild-to-moderate headaches during infusion. There were no treatment-related serious adverse events. Conclusions BMS-986231 demonstrated a favourable safety and haemodynamic profile in patients hospitalized with advanced heart failure. Based on preclinical data and these study's findings, it is possible that the haemodynamic benefits may be mediated by inotropic and/or lusitropic as well as vasodilatory effects. The therapeutic potential of BMS-986231 should be further assessed in patients with heart failure.