Ventricular Assist Device Outcomes Research Articles

Left Ventricular Assist Device Outcomes In Patients With Chronic Kidney Disease And End-stage Renal Disease

<h3>Background</h3> There is paucity of data regarding Left ventricular Assist Device (LVAD) outcomes in patients with advanced Chronic kidney disease (CKD) and End Stage Renal Disease (ESRD). <h3>Methods</h3> We conducted a retrospective study utilizing United States Renal Database (2006-2016) to compare 1-year outcomes between Medicare beneficiaries with ESRD to 5% sample of Medicare beneficiaries with CKD among LVAD patients. Comorbidities and outcomes were identified using appropriate ICD9 or ICD-10 codes. Patients who underwent heart transplant in follow up were excluded prior to obtaining outcomes. Subgroup analysis of CKD patients with available staging information [n=181(41.2%)] was explored to study CKD stage impact on outcomes. <h3>Results</h3> There were 482 patients with CKD and 192 patients with ESRD who underwent LVAD implantation. The ESRD group were 5 years younger and had more females compared to CKD group. Non-ischemic cardiomyopathy was more common in CKD vs ESRD (45.2% vs 23.9%, p <0.001). The details of baseline characteristics are shown in Table 1. The 1-year mortality is higher in ESRD when compared to CKD group (68.3% vs 35.5%, p <0.001). Median time to mortality in ESRD was 22 days (IQR; 6-55) and 46 days (IQR; 19-153) in CKD group. Out of patients with available baseline CKD staging, 91.2% had advanced CKD (stage III and above). Subgroup analysis in this cohort showed trend of increase in mortality from III (33.9%) to IV/V (40.9%). There were no significant differences in bleeding, pump thrombosis, stroke and sepsis/infection between two groups. <h3>Conclusions</h3> The patients with ESRD who receive LVAD have worse survival when compared to CKD group. There is also trend of gradual increase in mortality with worsening renal function. This information will help in shared decision making while considering advance heart failure therapies in CKD or ESRD patients.

Racial and Gender Disparities in the Prognostic Value of Galectin-3 in Post Left Ventricular Assist Device Outcomes

<h3>Purpose</h3> Galectin-3 is a novel biomarker, with elevated levels being linked to greater cardiovascular risk and poor outcomes in heart failure (HF) patients. McEvoy et al. found that Galectin-3 has better predictive value of HF outcomes in Caucasians compared to African Americans, however, this relationship and gender disparities have not been well explored in the Left Ventricular Assist Device (LVAD) population. The purpose of this study was to investigate gender and racial disparities in the LVAD population. <h3>Methods</h3> From 2012 to 2020, 171 LVAD patients at our institution had lab values collected for Galectin-3. Of these, 73 were African American, 76 were Caucasian, 110 were male, and 61 were female. Their outcomes, including right ventricular failure (RVF), time on inotropes, need for right ventricular assist device (RVAD), length ICU stay, and mortality were collected retrospectively. <h3>Results</h3> There was no significant difference in demographic variables besides age and BSA (Table 1). Galectin-3 correlated to inotrope duration in both African Americans (r=0.312, p=0.008) and Caucasians (r=0.295, p=0.013), but was only correlated with ICU stay in Caucasians (r=0.352, p=0.003), and not in African Americans (r=-0.006, p=0.963) There was significant correlation between Galectin-3 and Creatinine in Caucasians (r=0.425, p=0.001), but not in African Americans (r=0.078, p=0.509)Galectin-3 predicted inotrope duration in males (r=0.32, p=0.001) but not in females (r=0.28, p=0.07). Correlation was also found between Galectin-3 and Creatinine in males (r=-0.27, p=0.005), but not in females (r=-0.09, p=0.55). Galectin-3 predicted mortality in males with mean Galectin-3 of 28.6 ± 11.3 in those who died compared to 25.0 ± 12.2 in those who did not (p=0.05), while it did not in females, with mean Galectin-3 of 29.3 ± 17.6 in those who died compared to 28.0 ± 13.1 in those who did not (p=0.78). <h3>Conclusion</h3> The prognostic implications of Galectin-3 may be more pronounced in certain gender and racial groups.

Ventricular Assist Device Use in Pediatric Restrictive and Hypertrophic Cardiomyopathy: An Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Analysis

<h3>Purpose</h3> Use of ventricular assist devices (VAD) in patients with restrictive (RCM) and hypertrophic cardiomyopathy (HCM) remains low compared to use in dilated cardiomyopathy. We describe the outcomes of patients with RCM and HCM supported by VAD and characteristics associated with successful VAD support. <h3>Methods</h3> We examined the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry for outcomes of patients with RCM, HCM and mixed HCM/RCM who underwent VAD implantation from March 2012 - July 2021, including major adverse events, and survival. <h3>Results</h3> Fourteen patients were identified and represent 2.2% of the ACTION registry at data collection. There were 9 initial LVAD (with 2 subsequent RVAD) and 5 initial BIVAD (1 total artificial heart). Of 12 LVAD patients with data, 4 had LA and 8 had LV cannulation. Median age was 3.4 years (range 0.3-16.9), weight 15 kg (5.2-57.2), and BSA 0.64 m2 (0.29-1.67). Diagnoses included RCM (50%), HCM (35.7%), and mixed RCM/HCM (14.3%). Illness severity at implant was high with 29% Intermacs profile 1, 50% on ECMO, 57.1% on ventilator support, 85.7% on 1 or more inotrope, and 64.3% on TPN. Twenty devices were used in 14 patients: 10 (50%) paracorporeal pulsatile, 6 (30%) paracorporeal continuous, 3 (15%) implantable continuous, and 1 (5%) intracorporeal pulsatile. Median duration of support was 80 days (8-412). Four patients died on device, 9 transplanted and 1 alive on device. Though not statistically significant, patients who died had higher incidence of pre-VAD: ECMO, TPN, Intermacs profile 1, HCM, initial BIVAD and major VAD-related adverse events. Cause of death was inadequate support (1, HCM with Rotaflow BiVAD), infection (2), and multi-organ failure (1). <h3>Conclusion</h3> Patients with restrictive and hypertrophic cardiomyopathy have high pre-implant illness severity, however, most patients had successful VAD outcomes. VAD support is a reasonable strategy for select RCM and HCM patients.

Patient and Device Selection in Pediatric MCS: A Review of Current Consensus and Unsettled Questions.

The field of pediatric ventricular assist device (VAD) support has expanded significantly over the past 20years, with one third of pediatric heart transplant recipients currently being bridged to transplant with a VAD. Despite increased pediatric VAD utilization, however, there remains little formalized guidance for patient or device selection. The population of children with advanced heart failure is quite heterogeneous, and the available data suggest that VAD outcomes vary significantly based upon patient size, anatomy, level of illness, and type of device implanted. In an effort to better understand current practice patterns and identify populations for whom there does not appear to be a consensus approach to achieving optimal VAD outcomes, the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) has surveyed clinical decision-making among member sites and conducted a review of the available literature regarding patient population-specific VAD outcomes and center-specific practices related to patient and device selection. Rather than aiming to provide clinical guidelines, this document offers an overview of contemporary approaches to patient and device selection, highlighting specific populations for whom there is not a consensus approach to achieving reliably good VAD outcomes, as these populations may benefit most from future research and quality improvement efforts directed toward identifying best practice.

Impact of preoperative versus postoperative dialysis on left ventricular assist device outcomes: An analysis from the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support database

ObjectiveChronic kidney disease and renal failure are common in patients being considered for left ventricular assist device support. We sought to evaluate the outcomes of patients undergoing left ventricular assist device implantation with preoperative dialysis and those with new-onset postoperative renal failure requiring dialysis. MethodsAll patients (n = 14,090) undergoing primary left ventricular assist device implantation who were listed in the Interagency Registry for Mechanically Assisted Circulatory Support database (2014-2019) were evaluated. Landmark analysis then stratified patients alive at 1 month by preoperative dialysis and at 1 month postoperatively, preoperative dialysis only, postoperative dialysis only, and no dialysis. ResultsOf 14,090 patients undergoing left ventricular assist device implantation, patients on dialysis (400%, 3%) preoperatively had significantly higher mortality at 1 month (18% vs 6%, P < .0001). However, of patients on preoperative dialysis, 131 (32.8%) no longer required dialysis at 1 month postoperatively and had long-term survival similar to patients who never required dialysis (no dialysis vs recovered, P = .13). Long-term survival was significantly worse in patients with persistent dialysis and new dialysis at 1 month postoperatively (P < .0001). Time to first stroke, major nondevice infection, any bleeding event, and gastrointestinal bleeding were all worse in patients on preoperative or postoperative dialysis (all P < .0001). Device infection, malfunction, or thrombosis was not associated with dialysis status (P > .05). Negative predictors of recovery include biventricular assist device (odds ratio, 0.20) and inotropes 1 week postimplant (odds ratio, 0.19). ConclusionsPreoperative renal failure is associated with 3 times higher mortality and worse morbidity in patients receiving a left ventricular assist device. However, one-third of patients with preoperative dialysis will recover renal function postimplant with similar long-term survival and quality of life as those without dialysis.

Predicting Left Ventricular Assist Device Outcomes Utilizing the Stanford Integrated Psychosocial Assessment for Transplant Measure

Objective: Durable mechanical circulatory support is a proven therapy to extend survival for patients with end-stage heart failure (HF). The International Society for Heart and Lung Transplantation guidelines recommend a detailed psychosocial assessment when selecting candidates for durable mechanical circulatory support. Currently, there are no formally validated psychosocial evaluation tools for left ventricular assist device (LVAD) candidacy. The Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) uses a multidisciplinary algorithm to evaluate the impact of pre-transplant risk factors on post-transplant outcomes. Emerging literature suggests that the SIPAT might be useful for assessing psychosocial risk factors for LVAD outcomes. Methods: A total of 268 consecutive patients (median age 66 years, 84.6% male) with terminal HF were evaluated before LVAD implantation with a SIPAT assessment. Key outcomes included readmission and mortality rates at 30 days and two years. Results: After screening, 234 subjects met the inclusion criteria and were analyzed. The Patient Readiness subscale of the SIPAT was statistically significant in predicting two-year mortality (B = .167, P &lt; .001; Nagelkerke r2 = .106). Scores on the SIPAT did not correlate to 30-day readmission, 30-day mortality, or two-year readmission rates. Discussion: In this study, only the Patient Readiness score was associated with mortality at two-years post-implantation. This research elucidates the potential longer-term impact of psychosocial factors on LVAD outcomes and the SIPAT’s utility in evaluating LVAD candidacy.

Abstract 10817: Association of Hospital Procedural Volumes with Outcomes of Left Ventricular Assist Devices

Introduction: Left Ventricular Assist Devices (LVADs) are effective and feasible options for stage D heart failure. The impact of procedural volumes on LVAD outcomes has been seldomly investigated. Methods: We investigated the Nationwide Readmission Database for the impact of different institutional LVAD volumes on clinical outcomes in 2018. Institutional procedural volumes were stratified into Low (1-7/year), medium (8-24/year) and high (&gt;25/year). Multivariant analysis and adjusted odds ratio was performed to examine association between LVAD hospital volumes and outcomes. Primary outcome was major adverse events (MAE) defined as a composite of mortality, myocardial infarction, stroke or TIA, bleeding requiring transfusion, acute kidney injury, vascular complications and pericardial effusion or tamponade requiring pericardiocentesis or surgery. Results: A total of 2315 patients underwent LVAD placement, with a mean age of 57. No difference in age, sex or presence of chronic disease was noted among patient in different procedural volume tiers. There was statistically significant difference in MAE in medium-volume center when comparing to low volume centers. No difference in MAE was present in low and high-volume center. No significant difference was noted in 30-day all cause readmission, 30-day heart failure readmission or in individual components of MAE across different hospital procedural volumes. Conclusions: Medium-volume centers are associated with better composite clinical outcomes. Overall, no difference in mortality, stroke or myocardial infarction exists among different volume centers. Further clinical research is warranted to clarify the appropriate minimum LVAD procedural volumes required for accreditation.

Baseline Renal Function and Left Ventricular Assist Device Outcomes Among Patients with CKD

Baseline Renal Function and Left Ventricular Assist Device Outcomes Among Patients with CKD

Contemporary Nationwide Heart Transplantation and Left Ventricular Assist Device Outcomes in Patients with Histories of Bariatric Surgery

Bariatric surgery may play a role in the management of morbidly obese patients with end-stage heart failure through increasing eligibility and improving the outcomes of destination therapies. We conducted a nationally representative, retrospective cohort study of patients with previous bariatric surgery undergoing either heart transplantation or left ventricular assist device implantation. Of 200 patients, < 6% experienced in-hospital mortality after destination therapy, comparable to that reported in the general population of heart recipients. Risk-adjusted outcomes differed minimally from those of obese patients undergoing destination therapy without previous bariatric surgery. This study provides important safety benchmarking data and demonstrates the feasibility of bariatric surgery as a potential bridge to left ventricular assist device implantation or heart transplantation in obese patients with end-stage heart failure.

Contemporary Left Ventricular Assist Device Outcomes in an Aging Population: An STS INTERMACS Analysis

BackgroundSurvival, functional outcomes, and quality of life after left ventricular assist device (LVAD) are ill-defined in elderly patients, and with new-generation devices. ObjectivesThis study sought to evaluate survival, functional outcomes, and quality of life after LVAD in contemporary practice. MethodsAdults receiving durable LVADs between January 1, 2010, and March 1, 2020, were identified from the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) database. The primary outcome was adjusted survival; secondary outcomes included quality of life rated using a visual analogue scale (where 0 represents “worst health” and 100 “best health”); 6-minute walk distance; stroke; device malfunction; and rehospitalization, stratified by patient age. Median follow-up was 15 months (IQR: 6-32 months). ResultsThe cohort comprised 68.9% (n = 16,808) patients aged <65 years, 26.3% (n = 6,418) patients aged 65-75 years, and 4.8% (n = 1,182) patients aged >75 years, who were predominantly male (n = 19,119, 78%) and on destination therapy (n = 12,425, 51%). Competing outcomes analysis demonstrated mortality (70% CIs) of 34% (33%-34%), 54% (54%-55%), and 66% (64%-68%) for patients aged <65, 65-75, and >75 years, respectively, which improved during the study in patients aged >75 years. Newer-generation devices were associated with reduced late mortality (HR: 0.35; 95% CI: 0.25-0.49). Stroke, device malfunction or thrombosis, and rehospitalizations decreased with increasing age (all P < 0.01). Median 6-minute walk distance increased from 0 feet (IQR: 0-665 feet) to 1,065 feet (IQR: 642-1,313 feet) (P < 0.001), and quality of life improved from 40 (IQR: 15-60) to 75 (IQR: 60-90) (P < 0.001) after LVAD in all age groups. ConclusionsIn elderly patients, LVADs are associated with increased functional capacity, similar improvements in quality of life, and fewer complications compared with younger patients.

HeartWare HVAD Market Withdrawal and Impact on the Pediatric Field.

HeartWare HVAD Market Withdrawal and Impact on the Pediatric Field.

Clinical Outcomes of Ventricular Assist Device for Failing Bidirectional Glenn Physiology

Purpose The number of patients with failing single ventricle physiology is increasing, and ventricular assist device (VAD) support in this population is challenging. The purpose of this study was to describe our clinical experience with VAD for failing Glenn physiology. Methods A retrospective review of clinical outcomes was conducted in patients that underwent durable VAD placement for failing Glenn circulation between 2010 and 2020 at Texas Children's Hospital. Results Ten patients met inclusion criteria; all had a morphologic right ventricle (RV): 6 hypoplastic left heart syndrome/variant and 4 with isomerism with RV dominant atrioventricular septal defect. INTERMACS profiles were 1 in 3 patients (1 with ECMO) and 2 in 7 patients. Four patients were intubated. Age, weight, and body surface area at VAD implantation were 3.2 (0.9-10.1) years, 13.0 (7.7-22.8) kg, and 0.50 (0.36-0.90) m2, respectively. The device-strategy included HVAD in 6, Jarvik 2015 in 1, and Berlin cannula (with Berlin and/or Rotaflow pumps) in 3. Concomitant Fontan completion was performed in 5 patients (1 with fenestration), while the other 5 remained with Glenn circulation. PaO2/FiO2 ratio (median, range) on postoperative day 1 was significantly higher with Fontan completion [192 (53-336)] than without [76 (59-78), p=0.05] except a patient with Glenn circulation on ECMO. The median duration of mechanical ventilation after VAD was 2 days (range, 1 - 14). There was 1 early mortality 8 days after HVAD placement with Fontan completion due to neurologic insult intraoperatively. The remaining 9 patients (90%) were bridged to transplant at a median support duration of 3.8 (0.1-16.6) months. Five of the 6 HVAD patients were able to be discharged home prior to transplant. One patient encountered a pump thrombus requiring pump exchange and 1 patient suffered a thromboembolic stroke due to a mobile intraventricular thrombus. One patient had a subdural and subarachnoid hemorrhage 27 days after VAD implantation, with complete neurologic recovery without deficits. Conclusion This single-institutional experience suggests long term VAD support is sustainable for failing Glenn physiology with accompanying Fontan completion in selected patients. Further studies are warranted to optimize long term VAD support in this challenging population.

Ventricular Assist Device Outcomes in Children and Young Adults with Muscular Dystrophy: An ACTION Analysis

<h3>Purpose</h3> Cardiac disease results in significant morbidity and mortality in patients with muscular dystrophy (MD). Single centers have described their ventricular assist device (VAD) experience in this population, however broader applicability and outcomes remain unknown. <h3>Methods</h3> We examined outcomes of all patients with MD and dilated cardiomyopathy implanted with a VAD at Advanced Cardiac Therapies Improving Outcomes Network (ACTION) centers 9/2012-9/2020. <h3>Results</h3> A total of 19 VADs were implanted in 18 patients across 10 ACTION sites. The median duration of support was 252 days (range 11-1681 days). The majority of pts had dystrophinopathy (66%) and the median age at implant was 17.2 years (Table). Device strategy was bridge to transplant in 5 (27.8%), 4 of whom survived to transplant. The frequency of a positive outcome (transplanted or alive on device) at 6 months and 1 year were 89% and 84%, respectively (Figure). A single patient suffered a stroke (hemorrhagic), 2 patients developed sepsis, 1 patient developed respiratory failure requiring tracheostomy and 4 patients patient developed right heart failure (1 of whom required temporary right VAD). <h3>Conclusion</h3> In selected MD patients, VADs can serve as effective bridges to HT and chronic therapy. Right heart failure and infectious complications were relatively common, while stroke and respiratory failure were rare. Further research is needed to understand the patients who may benefit most from VAD therapy in terms of survival and quality of life and how to mitigate the risks the of the adverse events identified in the current report.

Outcomes of Mechanical Circulatory Support in Infants with Congenital Heart Disease Listed for Heart Transplant

<h3>Purpose</h3> Infants with congenital heart disease (CHD) and advanced heart failure are a growing population. We hypothesize that survival to transplant was superior in those infants supported with no MCS compared to those with ventricular assist device (VAD) or extracorporeal membrane oxygenation (ECMO). <h3>Methods</h3> This retrospective cohort study evaluates data from the 1987-2018 United Network for Organ Sharing (UNOS) database assessing patients <1yo with CHD who were listed for orthotopic heart transplant (OHT). Patients were divided into 3 categories at the time of listing and at time of transplant: No MCS, ECMO and VAD. The primary outcome was survival to transplant, while the secondary outcome was 1-year post-transplant survival. <h3>Results</h3> Analysis included 2755 patients of whom 62% (1705) survived to transplant and 50% (1378) survived from listing to 1-year post transplant. At the time of listing, 86% (2357) were not on MCS, 13% (360) were on ECMO, and 1% (38) on VAD. Average weight at the time of listing was 4.2±2.0 kg, with VAD patients larger (5.1±2.1 kg) than ECMO (4.0±1.5 kg) or no MCS (4.2±2.0 kg) (<i>p=0.003)</i>. At the time of listing, 53% of VAD patients, 62% of ECMO patients and 45% of patients without MCS were on inotropic support. In comparison to those patients not on MCS, death prior to transplant was highest for those patients on ECMO at listing, (HR 4.1, 95% CI 3.6-4.8) and equivocal if on VAD at listing (OR 1.6, 95% CI 1.0-2.5). 1-yr post-transplant mortality was higher if on ECMO at transplant (vs. no MCS, HR 4.0, 95% CI 3.0-5.3) but similar if on VAD at transplant (vs. no MCS, HR 1.4, 95% CI 0.8-2.5). <h3>Conclusion</h3> Infants with CHD listed for OHT have poor outcomes regardless of support modality, with less than 2/3 surviving to transplant and only half surviving to 1-year post-transplant. Patients supported with ECMO have particularly dismal survival, while VAD outcomes are similar to those not requiring MCS. Strategies to effectively improve survival in this high-risk cohort are urgently needed.

Outcomes of Infants and Children with Stage 1 Single Ventricle Implanted with Ventricular Assist Devices: An Analysis of the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Registry

<h3>Purpose</h3> Ventricular assist device (VAD) use in patients with congenital heart disease is increasing. Data on VAD outcomes in infants/children with stage 1 single ventricle (SV) are limited. Our study aims to characterize the outcomes of this population using multi-center registry data. <h3>Methods</h3> We examined the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry for outcomes of stage 1 SV patients undergoing VAD implantation between March 2018 - June 2020. ACTION data are collected from 30 centers, and major adverse events undergo central adjudication using pre-specified event definitions. Clinical characteristics, major adverse events, and survival are reported. <h3>Results</h3> During the study period, 27 stage 1 SV patients underwent VAD implant with median age of 1 month (range 0.1-44), weight 3.7kg (2.4-17), and BSA 0.24 m² (0.18-0.65). Pre-implant comorbidities were frequent: ventilator support (85%), ECMO (37%), history of cerebral vascular accident (CVA, 30%), and pre-implant dialysis (18.5%). Device strategy included paracorporeal continuous-flow VAD in 11 patients, paracorporeal pulsatile VAD (12), and multiple devices (4). Concomitant surgical procedure was performed in 4 patients. Median support duration was 56 days (2-271). A positive clinical outcome, defined as transplant, weaned, or alive on device was obtained in 59%, with 12 patients transplanted while 11 died on device (Fig 1). Adverse events on VAD support included neurologic dysfunction (18.5%, with n=2 CVA), bleeding (22%), infection (48%), renal dysfunction (15%), and device malfunction (4%). <h3>Conclusion</h3> Stage 1 SV patients undergoing VAD support have frequent and severe pre-implant comorbidities, which likely contributed to the significant morbidity and mortality post-implant. A variety of device types and surgical strategies are employed by centers to support this challenging physiology.

Outcomes of Ventricular Assist Device Use in Children for Bridge to Heart Retransplantation

<h3>Purpose</h3> As the use of pediatric ventricular assist devices (VAD) has increased, more children are being supported with VADs for transplant graft failure as a bridge to heart re-transplant (HT). Little is known about VAD outcomes for graft failure where left ventricular (LV) function is preserved, and LV chamber dilation is uncommon. We sought to examine VAD outcomes as a bridge to HT for this important subset of HF patients. <h3>Methods</h3> Organ Procurement and Transplant Network (OPTN) data were used to identify all children ≤21 years who underwent VAD placement between 2004 and 2020 as a bridge to heart re-transplant. Cox proportional hazard modeling was used to identify risk factors for mortality. <h3>Results</h3> Of 723 children listed for heart re-transplant, 144 were supported with MCS (87 with a VAD and 57 with ECMO alone). Of 87 VAD recipients, 41 (68%) received an LVAD alone, 29 (33%) received BIVADs, 9 (10%) received an TAH, and 7 (8%) an isolated RVAD. The most common isolated LVAD used was the Berlin Heart (N=16, 39%), a percutaneous LVAD (Impella or Tandem, N=11, 26%), and Heartware HVAD (N=6, 15%). The most common BIVAD configuration was bilateral Berlin Hearts (N=15, 52%) and bilateral CentriMag (10%). Since 2011 (when complete VAD survival data become available), overall survival to HT was 72%, with 61% reaching transplant while 11% remained on the waitlist. Survival was significantly worse compared to pediatric VAD patients supported for DCM and comparable to children with CHD (P=0.31) (Figure). For children supported with the Berlin Heart, outcomes for LVAD and BIVAD patients were similar (P=0.69) in contrast to other diagnoses where BIVAD outcomes are typically inferior to LVAD outcomes. <h3>Conclusion</h3> VAD outcomes for bridge to re-transplant are significantly worse than DCM patients and comparable to outcomes for CHD. While BIVAD outcomes are typically worse than LVAD outcomes for most cardiac diagnoses, outcomes appear similar for children supported for graft failure.

Impact of 2018 UNOS Allocation Policy Change on VAD Outcomes

<h3>Purpose</h3> In October 2018 the UNOS Allocation Policy for heart transplantation was changed to prioritize more critically-ill patients. Before the allocation change, patients with ventricular assist devices (VADs) were listed as Status 1B which was changed to Status 4. We sought to investigate the impact this change in policy had on survival outcomes. <h3>Methods</h3> All adult patients who were registered for heart transplantation with VAD for the year before (PRE, n=633) and after (POST, n=567) the UNOS 2018 Allocation policy change were analyzed. Baseline characteristics were compared using Mann-Whitney U test and Chi-square test as appropriate. Kaplan-Meier survival analysis was performed for 6 months post-transplantation. <h3>Results</h3> There was no difference in 6 month post transplantation survival in VAD patients in PRE and POST groups. Total days on the waiting list was lower in the POST group (median+IQR) (32 [10.0, 96] vs. 59.0 [22.0,121.0]), p<0.001. Baseline characteristics between recipient groups were similar. <h3>Conclusion</h3> After the 2018 policy change there was no difference in 6 month survival among patients with VADs compared to prior. There was a shorter wait time to transplantation for patients with VADs in the POST group. Further analysis on implications of UNOS policy changes are warranted.

Outcomes of Temporary Percutaneous Right Ventricular Assist Devices in Right Ventricular Failure

Purpose Right ventricular failure occurs in a variety of clinical settings and is associated with worse survival. We describe our clinical experience with two temporary percutaneous right ventricular assist devices (RVADs): TandemLife Protek Duo (TPD) and Impella RP. Methods A prospectively maintained institutional registry was used to identify patients requiring TPD and Impella RP support. Baseline characteristics, etiology of heart failure, indication for RVAD support, timing of implantation in relation to the onset of right ventricular (RV) failure were characterized. Specific clinical outcomes, including overall survival, time on temporary percutaneous RV support, device explant and device exchange rates were analyzed. Outcomes were further analyzed among the cohort of explanted patients. Results Between January 2015 and December 2018, 19 TPD devices and 10 Impella RP devices were implanted. Indication for RV support included post-left ventricular assist device implantation RV failure, post-cardiotomy cardiogenic shock, and post-transplant RV failure. Mean (median) support duration for TPD was 16 (12) days, and 5 (4) days for Impella RP. Among TPD patients, 11 (57.9%) were explanted, 4 (21.0%) died, and there were no device exchanges. Among Impella RP patients, 5 (50.0%) were explanted, 3 (30.0%) died, and 1 (10.0%) required device exchange. Among TPD patients explanted, 7 (63.6%) recovered and were weaned, 3 (27.2%) died, and 1 (9.1%) required a durable RVAD. Among Impella RP patients explanted, 4 (80.0%) recovered and were weaned, and 1 (20.0%) required a durable RVAD. Conclusion RV failure is associated with reduced survival. Temporary percutaneous RVAD devices provide a suitable strategy for bridging patient to recovery.

Outcomes of Ventricular Assist Device Use for Bridge to Heart Transplant in Children with Single-Ventricle Heart Disease

<h3>Purpose</h3> As the use of pediatric ventricular assist devices (VAD) has increased, more children are being supported with VADs for single-ventricle heart disease (SVD). Little is known about outcomes for this rapidly growing population of advanced HF patients. We sought to examine trends in VAD use for SVD and to assess outcomes. <h3>Methods</h3> Organ Procurement and Transplant Network (OPTN) data were used to identify all children ≤21 years who underwent VAD placement between 2004 and 2020 for SVD. Cox proportional hazard modeling was used to identify risk factors for mortality defined as death or clinical deterioration. <h3>Results</h3> Of 1955 children with SVD, 315 were supported with an MCS device (145 SVADs and 170 ECMO only). Of the SVADs, 142 (97%) received an SVAD alone as the primary device, 2 (1%) received BIVADs and 1 (1%) a TAH. The most common VAD brands were the Berlin Heart EXCOR (N=44, 30%), the CentriMag/PediMag (N=40, 28%), Heartware HVAD (N=35, 24%), and the CentriMag/PediMag (ZZ%) and the Heartmate III (N=8, 6%). Since 2011 (when complete VAD survival data become available), overall survival to HT was 62% of whom 58% reached transplant; 38% died or deteriorated, and 2% recovered. Survival was significantly worse compared to pediatric VAD patients supported for DCM and comparable to patients supported for 2-ventricle CHD (P=0.79) (Find). Survival to transplant was highest for adult continuous flow devices (77%) and lower for the CentriMag/PediMag system (63%) and the Berlin Heart EXCOR (63%). <h3>Conclusion</h3> VAD outcomes for bridge to transplant for single-ventricle heart disease patients are similar to other forms of 2-ventricle CHD but inferior to DCM. The highest survival appears to be in patients receiving adult CF devices with room for improvement in smaller patients receiving non-dischargeable devices.

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.