Left Ventricular Assist Device Group Research Articles

Comparative analysis of multi-organ failure trajectories reflected by the MELD-3.0 following heart transplantation and heartmate 3 implantation

Abstract Background Multi-organ failure (MOF) frequently complicates advanced heart failure (HF), substantially impacting patient prognosis. The Model of End-Stage Liver Disease 3.0 (MELD-3.0) scale, encompassing liver and kidney function parameters, is a valuable tool for assessing the severity of organ dysfunction. Purpose This study aims to elucidate the trajectory of MOF in individuals undergoing either heart transplantation (HTx) or left ventricular assist device (LVAD) - HeartMate 3 implantation, utilizing the MELD-3.0 scale, over a 1-year follow-up period. Methods A comprehensive analysis was conducted, examining data from 1 month preceding to 1 year subsequent to the HTx or LVAD implantation. The MELD-3.0 score was calculated using the average values of international normalized ratio, bilirubin, creatinine, sodium, and albumin levels during this timeframe. Comparative assessments of the average MELD-3.0 scores were performed between the HTx and LVAD groups at 1 month pre-procedure, as well as at 1 week, 1 month, 3 months, 6 months, and 1 year post-procedure. Results The analysis included 107 patients undergoing HTx and 31 patients undergoing HMi, with a median age of 54 years (47-62), 85% were male. There was no difference in MELD-3.0 between HTx and LVAD patients in the pre-procedure period: 12.3 (7.3-15.9) vs 13.1 (7.7-16.6), p=0.95. There was also no difference in MELD-3.0 at 1 week and 1 month post-procedure. However, in the 3rd month, the difference gained statistical significance: 7.3 (4.6-9.4) vs 13.8 (11.5-19.7), p<0.01 and continued to be significant in the next follow-ups: 12-month 5.4 (3.1-10.2) vs 11.1 (6.7—15.1), p<0.01, comparing respectively HTx vs LVAD. In both groups of patients, a significant decrease in MELD-3.0 score from 3-month follow-up when compared to 1 month preceding the procedure was observed. Within 12 months post-procedure, 30 patients (22%) died (19 in HTx group and 11 in LVAD group), 8 LVAD patients (26%) had HTx. Conclusion The utilization of the MELD-3.0 scale reveals significant differences in the trajectory of multi-organ failure between HTx and LVAD patients. Both forms of advanced HF therapy result in an improvement of liver and kidney condition, while HTx patients' benefits are larger and last longer, highlighting the distinct impacts of this intervention on organ function.MELD 3.0 score in time

Propensity score-based comparison of high-risk coronary artery bypass grafting vs. left ventricular assist device implantation in patients with coronary artery disease and advanced heart failure.

Revascularization in patients with severely reduced left ventricular function and coronary artery disease (CAD) is associated with a high perioperative risk. In this setting, implantation of a durable left ventricular assist device (LVAD) might be an alternative. We retrospectively compared the outcomes of adult patients with CAD and a left ventricular ejection fraction (LVEF) ≤ 25% who underwent coronary artery bypass grafting (CABG) vs. LVAD implantation. Propensity score (PS) matching was performed for statistical analysis, resulting in 168 pairs. In the PS-matched cohorts, the mean age was 62 years; one third had a history of myocardial infarction, 11% were resuscitated, half of the patients were on inotropic support, and 20% received preoperative mechanical circulatory support. LVAD patients required significantly longer ventilation (58 h [21, 256] vs. 16 h [9, 73], p < 0.001) and had a longer ICU stay (11d [7, 24] vs. 4d [2, 10], p ≤ 0.001) compared to CABG patients The incidence of postoperative renal replacement therapy (2 [1.2%] vs.15 [8.9%], p = 0.002) and temporary mechanical circulatory support was lower in the LVAD group (1 [0.6%] vs. 51 [30.4%], p ≤ 0.001). The in-hospital stroke rate was similar (LVAD 7 [5.4%] vs. CABG 8 [6.2%], p = 0.9). In-hospital survival, 1-year survival, and 3-year survival were 90.5% vs. 85.5% (p = 0.18), 77.4% vs. 68.9% (p = 0.10) and 69.6% vs. 45.9% (p < 0.001), for CABG and LVAD patients respectively. Patients with CAD and advanced HF demonstrate better mid-term survival if they undergo CABG rather than LVAD implantation.

Characterizing Adaptive Changes and Patient Survival After 2018 Donor Allocation Restructuring: A UNOS Database Analysis.

We sought to characterize adaptive changes to the revised United Network for Organ Sharing donor heart allocation policy and estimate long-term survival trends for heart transplant (HTx) recipients. Patients listed for HTx between October 17, 2013 and September 30, 2021 were identified from the United Network for Organ Sharing database, and stratified into pre- and postpolicy revision groups. Subanalyses were performed to examine trends in device utilization for extracorporeal membranous oxygenation (ECMO), durable left ventricular assist device (LVAD), intra-aortic balloon pump (IABP), microaxial support (Impella), and no mechanical circulatory support (non-MCS). Survival data post-HTx were fitted to parametric distributions and extrapolated to 5 years. We identified 27,523 HTx waitlist candidates during the study period, most of whom (n = 16,376) were waitlisted in the prepolicy change period. Overall, 19,554 patients underwent HTx during the study period (pre: 12,037 and post: 7517). Listings increased after the policy change for ECMO ( P < 0.01), Impella ( P < 0.01), and IABP ( P < 0.01) patients. Listings for LVAD ( P < 0.01) and non-MCS ( P < 0.01) patients decreased. HTx increased for ECMO ( P < 0.01), Impella ( P < 0.01), and IABP ( P < 0.01) patients after the policy change and decreased for LVAD ( P < 0.01) and non-MCS ( P < 0.01) patients. Waitlist survival increased for the overall ( P < 0.01), ECMO ( P < 0.01), IABP ( P < 0.01), and non-MCS ( P < 0.01) groups. Waitlist survival did not differ for the LVAD ( P = 0.8) and Impella ( P = 0.1) groups. Post-transplant survival decreased for the overall ( P < 0.01), LVAD ( P < 0.01), and non-MCS ( P < 0.01) populations. Allocation policy revisions have contributed to greater utilization of ECMO, Impella, and IABP, decreased utilization of LVADs and non-MCS, increased waitlist survival, and decreased post-HTx survival.

Bridge-to-transplant temporary mechanical circulatory support and risk of allosensitization.

Since the 2018 change in the US adult heart allocation policy, more patients are bridged-to-transplant on temporary mechanical circulatory support (tMCS). Previous studies indicate that durable left ventricular assist devices (LVAD) may lead to allosensitization. The goal of this study was to assess whether tMCS implantation is associated with changes in sensitization. We included patients evaluated for heart transplants between 2015 and 2022 who had alloantibody measured before and after MCS implantation. Allosensitization was defined as development of new alloantibodies after tMCS implant. A total of 41 patients received tMCS before transplant. Nine (22.0%) patients developed alloantibodies following tMCS implantation: 3 (12.0%) in the intra-aortic balloon pump group (n=25), 2 (28.6%) in the microaxial percutaneous LVAD group (n=7), and 4 (44.4%) in the veno-arterial extra-corporeal membrane oxygenation group (n=9)-p=.039. Sensitized patients were younger (44.7±11.6 years vs. 54.3±12.5 years, p=.044), were more likely to be sensitized at baseline - 3 of 9 (33.3%) compared to 2 out of 32 (6.3%) (p=.028) and received more transfusions with red blood cells (6 (66.6%) vs. 8 (25%), p=.02) and platelets (6 (66.6%) vs. 5 (15.6%), p=.002). There was no significant difference in tMCS median duration of support (4 [3,15] days vs. 8.5 [5,14.5] days, p=.57). Importantly, out of the 11 patients who received a durable LVAD after tMCS, 5 (45.5%) became sensitized, compared to 4 out of 30 patients (13.3%) who only had tMCS-p=.028. Our findings suggest that patients bridged-to-transplant with tMCS, without significant blood product transfusions and a subsequent durable LVAD implant, have a low risk of allosensitization. Further studies are needed to confirm our findings and determine whether risk of sensitization varies by type of tMCS and duration of support.

HeartMate 3 implantation with an emphasis on the biventricular configuration.

Right ventricular failure following implantation of a durable left ventricular assist device (LVAD) is a major driver of mortality. Reported survival following biventricular (BiVAD) or total artificial heart (TAH) implantation remains substantially inferior to LVAD alone. We report our outcomes with LVAD and BiVAD HeartMate 3 (HM3). Consecutive patients undergoing implantation of an HM3 LVAD between November 2014 and December 2021, at The Alfred, Australia were included in the study. Comparison was made between the BiVAD and LVAD alone groups. A total of 86 patients, 65 patients with LVAD alone and 21 in a BiVAD configuration underwent implantation. The median age of the LVAD and BiVAD groups was 56 years (Interquartile range 46-62) and 49 years (Interquartile range 37-55), respectively. By 4 years after implantation, 54% of LVAD patients and 43% of BiVAD patients had undergone cardiac transplantation. The incidence of stroke in the entire experience was 3.5% and pump thrombosis 5% (all in the RVAD). There were 14 deaths in the LVAD group and 1 in the BiVAD group. The actuarial survival for LVAD patients at 1 year was 85% and BiVAD patients at 1 year was 95%. The application of HM 3 BiVAD support in selected patients appears to offer a satisfactory solution to patients requiring biventricular support.

Synchrotron-based X-ray phase contrast imaging of transmural cardiac tissue in patients treated for advanced heart failure

Abstract Background Cardiac imaging is essential for identifying structural changes in advanced heart failure (HF) and understanding underlying pathophysiology. Synchrotron radiation-based X-ray phase contrast imaging (X-PCI) is a non-destructive imaging modality that can provide high resolution three-dimensional (3D) visualisation of cardiac tissue on the microstructural level. Thus far, such analyses including the quantification of myocyte aggregates ranging from the epicardium to the endocardium, have been confined to animal models and human fetal tissue. We aimed to explore the feasibility of using X-PCI to quantify and compare structural organisation and orientation of myocyte aggregates in the myocardium across different advanced HF aetiologies. Methods and design Four adult patients were included - two receiving a left ventricular assist device (LVAD), and two undergoing heart transplantation (HTx). Aetiology of advanced HF in both the LVAD and HTx group was ischaemic heart disease and dilated cardiomyopathy (DCM), respectively. Transmural tissue samples were obtained by left ventricular apical coring (LVAD) and from the explanted hearts (HTx). The tissue specimens were imaged by X-PCI at the TOMCAT beamline using an effective pixel size of 5.8 µm. Orientation of aggregates of cardiomyocytes was assessed using a structure tensor-based method and morphological parameters were derived - the helical angle (HA), or the angle between the circumferential left ventricular plane and myocyte aggregates, and fractional anisotropy (FA), the degree of anisotropy or disorganisation of the local myocardium. Results The general patient characteristics are shown in Table 1. X-PCI enabled 3D visualisation of transmural myocardial tissue samples showing differences in organisation of myocardial structure in different HF aetiologies (Figure 1). The epicardial adipose layer was thicker in DCM, paired with a thinner epicardial myocyte layer (yellow arrows). Furthermore, the epi-to-endocardial HA transition was clearly visualized in ICM (double arrows), whereas there was clear disruption of the HA gradient in DCM samples – a finding further quantified via FA (green arrows). Conclusion X-PCI allows non-destructive advanced imaging of ex-vivo tissue. By harnessing the power of digital 3D imaging on a cellular level, it provides a novel insight to differential information on tissue organisation in different aetiologies of advanced heart failure.Table 1Figure 1

Abstract 12573: Differences in Blood Product Consumption Between Ventricular Assist Device and Extracorporeal Membrane Oxygenation During Postoperative Period

Introduction: Mechanical circulatory supports such as veno-arterial extracorporeal membrane oxygenation (ECMO) and left ventricular assist device (LVAD) are used in advanced heart failure patients. Due to their thrombogenic surfaces, these devices can lead to disseminated thrombosis. The need for anticoagulation also predisposes to hemorrhage, in addition to hemolysis from shear stress. As a result, transfusion of blood components is usually warranted following implantation. Hypothesis: To evaluate the differences in the need for transfusion of blood products between these devices during immediate postoperative period up to day 3. Methods: Fifty-four patients with advanced heart failure patients admitted at our facility between January 2016-2019 were included. All patients were anticoagulated with continuous heparin infusion. We analyzed the need for packed red blood cells (pRBC), fresh frozen plasma (FFP), and platelet transfusion. Lactate dehydrogenase (LDH), CBC, aPTT, and PT were also measured. The study was approved by Institutional Review Board (#L19-093). Results: A total of 54 patients (25 patients received ECMO and 29 patients received LVAD) were included. The median age was 56 years [47-62]. Thirty-eight patients (70.4%) were male. The means daily substitution of pRBC were significantly lower in the LVAD group on day 2 (0.35 vs 2.64 units/day, p=0.002) and day 3 (0.58 vs 1.64 units/day, p=0.028). The means daily substitution of platelets were comparable between the ECMO and LVAD groups. A trend toward the lower mean daily substitution of FFP in the LVAD group on day 2 (0 vs 0.44 units/day, p=0.069) was seen. There was a significantly lower serum LDH in the LVAD group on day 3 (391 ± 345 vs 599 ± 268, p=0.003). Conclusions: Data from this retrospective study showed that, compared to ECMO, LVAD was associated with lower rates of hemolysis and pRBC transfusion.

Abstract 14769: Peripheral Venous Pressure Measured With a Novel Miniature Pressure Transducer Correlates With Central Venous Pressure in Heart Failure, Heart Transplant, and Left Ventricular Assist Device Patients

Introduction: Peripheral venous pressure (PVP) has been shown to accurately correlate with central venous pressure (CVP) when measured using a conventional manometer and pressure tubing. We investigated the correlation between PVP as measured by a novel pressure transducer and CVP in heart failure (HF), heart transplant (HTx), and left ventricular assist device (LVAD) patients. Methods: A prospective, cross-sectional study examining PVP from February 2022 to May 2023 was conducted. The analysis was limited to patients undergoing right heart catheterization (RHC) admitted for HF, post-HTx monitoring, or LVAD hemodynamic testing. PVP was transduced from an antecubital or more distal peripheral intravenous (IV) catheter site using a miniature digital, disposable pressure transducer (Centurion Compass Universal HG, Medline). Pressures were compared using Pearson’s correlation coefficient. Results: 99 patients were enrolled with a mean age of 62 ± 12 years and a mean ejection fraction (EF) of 41 ± 21%. 74% of the patients had heart failure, 17% were HTx patients, and 9% were LVAD patients. The PVP measured with the novel pressure transducer was found to be highly correlated to CVP measured by RHC (r=0.80, p &lt; 0.0001) (Figure). High correlation was also noted when broken down by HF (r=0.77, p &lt; 0.0001), HTx (r=0.95, p &lt; 0.0001), and LVAD groups (r=0.90, p &lt; 0.0003). There was a high degree of correlation for HF patients with EF &lt; 50% (r=0.74, p &lt; 0.0001) and EF &gt; 50% (r=0.90, p &lt; 0.0001). A high degree of correlation was found for all peripheral IV insertion sites: antecubital (r=0.86, p=0.000071), forearm (r=0.76, p&lt;0.00001), and hand (r=0.84, p&lt;0.00001). Conclusions: There is a high degree of correlation between PVP measured by a novel pressure transducer and CVP in HF, HTx, and LVAD patients. PVP measurements using this transducer are a reliable estimate of volume status in these patient populations.

Heart Transplant Outcomes After Total Artificial Heart

We sought to compare heart transplant (HTX) outcomes from patients with a total artificial heart (TAH), biventricular assist device (BiVAD), or left ventricular assist device (LVAD) as a bridge to transplant (BTT). Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS)-Scientific Registry of Transplant Recipients (SRTR) created a dataset with TAH or durable mechanical circulatory support (MCS) who reached HTX between 2006 and 2015. The retrospective analysis compared TAH outcomes with those with a BiVAD or LVAD before HTX. The primary outcome was posttransplant survival at 1, 36, and 60 months. Secondary outcomes included simultaneous heart-kidney transplants, donor characteristics, and mortality risk factors. INTERMACS-SRTR cohort had, at the time of HTX, 2762 patients with LVAD; 205 BiVAD (139 durable and 66 temporary RVAD); 176 TAH (6 prior HeartMate II). Sixty months after HTX, mortality rates were 16.5% in the total group: LVAD 15.2%, BiVAD 22.4%, and TAH 29%. Survival differed between the LVAD, the TAH, and BiVAD but not between the BiVAD and TAH groups. One-year survival and complication rates were similar across groups-there was no difference in survival by donor age in the overall cohort. There was a difference in TTD based on recipient age in the LVAD group but not in BiVAD or TAH groups. Occurrence of HTX-kidney and post-transplant dialysis were higher in the TAH versus LVAD and BiVAD groups. The TAH is an efficacious BTT. Refinements in technology and patient selection may improve outcomes.

Blood flow kinetic energy is a novel marker for right ventricular global systolic function in patients with left ventricular assist device therapy.

Right ventricular (RV) failure remains a major concern in heart failure (HF) patients undergoing left ventricular assist device (LVAD) implantation. We aimed to measure the kinetic energy of blood in the RV outflow tract (KE-RVOT) - a new marker of RV global systolic function. We also aimed to assess the relationship of KE-RVOT to other echocardiographic parameters in all subjects and assess the relationship of KE-RVOT to hemodynamic parameters of RV performance in HF patients. Fifty-one subjects were prospectively enrolled into 4 groups (healthy controls, NYHA Class II, NYHA Class IV, LVAD patients) as follows: 11 healthy controls, 32 HF patients (8 NYHA Class II and 24 Class IV), and 8 patients with preexisting LVADs. The 24 Class IV HF patients included 21 pre-LVAD and 3 pre-transplant patients. Echocardiographic parameters of RV function (TAPSE, St', Et', IVA, MPI) and RV outflow color-Doppler images were recorded in all patients. Invasive hemodynamic parameters of RV function were collected in all Class IV HF patients. KE-RVOT was derived from color-Doppler imaging using a vector flow mapping proprietary software. Kruskal-Wallis test was performed for comparison of KE-RVOT in each group. Correlation between KE-RVOT and echocardiographic/hemodynamic parameters was assessed by linear regression analysis. Receiver operating characteristic curves for the ability of KE-RVOT to predict early phase RV failure were generated. KE-RVOT (median ± IQR) was higher in healthy controls (55.10 [39.70 to 76.43] mW/m) than in the Class II HF group (22.23 [15.41 to 35.58] mW/m, p < 0.005). KE-RVOT was further reduced in the Class IV HF group (9.02 [5.33 to 11.94] mW/m, p < 0.05). KE-RVOT was lower in the LVAD group (25.03 [9.88 to 38.98] mW/m) than the healthy controls group (p < 0.005). KE-RVOT had significant correlation with all echocardiographic parameters and no correlation with invasive hemodynamic parameters. RV failure occurred in 12 patients who underwent LVAD implantation in the Class IV HF group (1 patient was not eligible due to death immediately after the LVAD implantation). KE-RVOT cut-off value for prediction of RV failure was 9.15 mW/m (sensitivity: 0.67, specificity: 0.75, AUC: 0.66). KE-RVOT, a novel noninvasive measure of RV function, strongly correlates with well-established echocardiographic markers of RV performance. KE-RVOT is the energy generated by RV wall contraction. Therefore, KE-RVOT may reflect global RV function. The utility of KE-RVOT in prediction of RV failure post LVAD implantation requires further study.

Left ventricular assist device mode: Co-pulse left ventricular unloading in a working mode of ex vivo heart perfusion

For normothermic ex vivo heart perfusion (EVHP), a resting mode and working mode have been proposed. We newly developed a left ventricular assist device (LVAD) mode that supports heart contraction by co-pulse synchronized LVAD. Following resting mode during time 0 to 1 hour, pig hearts (n=18) were perfused in either resting, working, or LVAD mode during time 1 to 5 hour, and then myocardial function was evaluated in working mode at 6 hour. The preservation ratio was defined as the myocardial mechanical function at 330 minute divided by the function at 75 minute. In LVAD mode, LVAD unloaded the pressure and the volume in the left ventricle in the systolic phase. The LVAD group was significantly associated with higher preservation ratios in cardiac output (resting, 33 ± 3; working, 35 ± 5; LVAD, 76% ± 5%; p < 0.001), stroke work, dP/dt maximum, and dP/dt minimum compared with the other groups. Glucose consumption was significantly reduced in the resting group. The LVAD group was significantly associated with higher myocardial oxygen consumption (resting, 2.2 ± 0.3; working; 4.6 ± 0.5; LVAD, 6.1 ± 0.5 mL O2/min/100 g, p < 0.001) and higher adenosine triphosphate (ATP) levels (resting, 1.1 ± 0.1; working, 0.7 ± 0.1; LVAD, 1.6 ± 0.2 μmol/g, p=0.001) compared with the others. These data suggest that myocardial mechanical function was better preserved in LVAD mode than in resting and working modes. Although our data suggested similar glycolysis activity in the LVAD and working groups, the higher final ATP in the LVAD group might be explained by reduced external work in LVAD.

Outcomes of concomitant aortic valve procedures and left ventricular assist device implantation: A systematic review and meta-analysis.

Left ventricular assist device (LVAD) implantation is frequently employed in patients with end-stage heart failure. The outcomes of addressing the repair of all substantial aortic valvular disease at the time of LVAD implantation remain unclear. We sought to assess the clinical outcomes in patients undergoing LVAD implantation concomitant with aortic valve procedures (AVPs) compared with isolated LVAD implantation. A literature search was performed using PubMed, Embase, and Cochrane library from inception till June 2022. Primary outcomes included short-term mortality and long-term survival. Random effects models were used to compute mean differences and odds ratios with 95% confidence intervals (CIs). A total of 14 observational studies (N=52 693) met our inclusion criteria. Concomitant LVAD implantation and AVPs were associated with higher short-term mortality (OR=1.61 [95% CI, 1.06-2.42]; p=0.02) and mean CPBt (MD=43.25 [95% CI, 22.95-63.56]; p < 0.0001), and reduced long-term survival (OR=0.70 [95% CI, 0.55-0.88]; p=0.003) compared with isolated LVAD implantation. No difference in the odds of cerebrovascular accident (OR=1.05 [95% CI, 0.79-1.39]; p=0.74) and mean length of hospital stay (MD=2.89 [95% CI, -4.04 to 9.82]; p=0.41) was observed between the two groups. On adjusted analysis, short-term mortality was significantly higher in the LVAD group with concurrent AVPs when compared with the isolated LVAD group (aHR=1.50 [95% CI, 1.20-1.87]; p=0.0004). Concurrent AVPs were associated with higher short-term mortality and reduced long-term survival in patients undergoing LVAD implantation compared with isolated LVAD implantation.

Microembolic signal monitoring in patients with HeartMate 3 and HeartWare left ventricular assist devices: Association with antithrombotic treatment and cerebrovascular events.

In patients with left ventricular assist devices (LVADs), ischemic and hemorrhagic stroke are dreaded complications. Predictive markers for these events are lacking. This study aimed to investigate the prevalence and predictive value of microembolic signals (MES) for stroke, detected by Transcranial Doppler sonography (TCD) in patients with HeartMate 3 (HM 3) or HeartWare (HW). A thirty-minute bilateral TCD monitoring of the middle cerebral artery (MCA) was performed in 62 outpatients with LVAD (HM 3N=31, HW N=31) and 31 healthy controls. Prevalence and quantity of MES were investigated regarding clinical and laboratory parameters. Cerebrovascular events (CVE) were recorded on follow-up at 90 and 180 days. MES were detected in six patients with HM 3, three patients with HW, and three controls. Within the LVAD groups, patients on monotherapy with vitamin-K-antagonist (VKA) without antiplatelet therapy were at risk for a higher count of MES (negative binomial regression: VKA: 1; VKA + ASA: Exp(B)=0.005, 95%CI 0.001-0.044; VKA + clopidogrel: Exp(B)=0.012, 95%CI 0.002-0.056). There was no association between the presence of MES and CVE or death on follow-up (p > 0.05). For the first time, the prevalence of MES was prospectively investigated in a notable outpatient cohort of patients with HM 3 and HW. Despite optimized properties of the latest LVAD, MES remain detectable depending on antithrombotic therapy. No association between MES and CVE could be detected.

Impact of Continuous Flow Left Ventricular Assist Device on Heart Transplant Candidates: A Multi-State Survival Analysis.

(1) Objectives: The aim of this study was to investigate the impact of the prolonged use of continuous-flow left ventricular assist devices (LVADs) on heart transplant (HTx) candidates. (2) Methods: Between January 2012 and December 2019, we included all consecutive patients diagnosed with end-stage heart failure considered for HTx at our institution, who were also eligible for LVAD therapy as a bridge to transplant (BTT). Patients were divided into two groups: those who received an LVAD as BTT (LVAD group) and those who were listed without durable support (No-LVAD group). (3) Results: A total of 250 patients were analyzed. Of these, 70 patients (28%) were directly implanted with an LVAD as BTT, 11 (4.4%) received delayed LVAD implantation, and 169 (67%) were never assisted with an implantable device. The mean follow-up time was 36 ± 29 months. In the multivariate analysis of survival before HTx, LVAD implantation showed a protective effect: LVAD vs. No-LVAD HR 0.01 (p < 0.01) and LVAD vs. LVAD delayed HR 0.13 (p = 0.02). Mortality and adverse events after HTx were similar between LVAD and No-LVAD (p = 0.65 and p = 0.39, respectively). The multi-state survival analysis showed a significantly higher probability of death for No-LVAD vs. LVAD patients with (p = 0.03) or without (p = 0.04) HTx. (4) Conclusions: The use of LVAD as a bridge to transplant was associated with an overall survival benefit, compared to patients listed without LVAD support.

Defibrillator generator replacements in patients with left ventricular assist device support: The risks of hematoma and infection.

The majority (89%) of left ventricular assist device (LVAD) patients have an implantable cardioverter-defibrillator (ICD) in place. Due to the advances of modern-day LVAD therapy, more patients are on support for longer. This inevitably leads to more LVAD patients facing ICD generator battery depletion. Until now, there are insufficient data regarding periprocedural risks of generator replacements in a high-risk group like the LVAD cohort. A retrospective, single-center analysis of pocket-related outcomes of all ICD generator replacements in LVAD and Non-LVAD patients between January 2014 and December 2018. The primary outcome was the combined endpoint of clinically significant pocket hematoma and/or cardiac implantable electronic device (CIED) infection in the first 6 months after ICD generator exchange. The clinically significant hematoma was defined as hematoma requiring reoperation, prolongation of hospitalization, or interruption of anticoagulation. The cumulative incidence function was calculated for the primary endpoint. Two hundred seventy-seven patients underwent ICD generator exchange in our clinic in this time. Of these, 251 patients had a complete 6-month follow-up regarding clinically significant pocket hematomas and pocket infections. One hundred ninety patients had no LVAD, and 61 patients were on LVAD support. The rate of the primary combined endpoint clinically significant pocket hematoma and/or CIED infection was 3.5 times higher in LVAD patients compared to the non-LVAD cohort (event rate 39.14 vs 11.07 per 100 patient-years, p=0.048). Clinically significant pocket hematomas necessitating revision occurred nearly 4 times more often in the LVAD group (p=0.042). Pocket device infection rates were around 16 times higher in LVAD patients compared to non-LVAD patients (p=0.002). Compared to Non-LVAD patients, LVAD patients exhibit a relevant higher rate of clinically significant pocket hematoma and CIED infection after ICD generator exchange. This information should additionally be considered in the decision-making process regarding the indication for ICD generator exchange.

P53: Postoperative Leukocytosis Trends in Ventricular Assist Device Implantation and Coronary Artery Bypass Graft Surgery

Background and Objective: Leukocytosis is a marker of inflammation due to infectious or non-infectious etiologies and is seen after coronary artery bypass graft surgery (CABG) and left ventricular assist device (LVAD) placement. Differentiating reactive postoperative leukocytosis from post-operative infection can drive antimicrobial stewardship initiatives. In this study, we aimed to describe the expected temporal trend of white blood cell (WBC) counts after LVAD placement compared to CABG. Methods and Analysis: We conducted a retrospective chart review of adult patients who underwent durable LVAD implantation or on-pump CABG between 2017-2019 at a single university-affiliated tertiary care hospital in Washington, DC. We excluded patients who were undergoing LVAD exchange, percutaneous VAD placement, had kidney failure requiring renal replacement therapy or transplant, had thromboembolism <14 days before the procedure, clinical or microbiological evidence of systemic infection <7 days before the procedure, were on steroids ≥5 mg prednisone daily, had a history of hematologic malignancy or acquired immunodeficiency syndrome. We compared the WBC count trend postoperatively after LVAD placement vs. CABG until day 24 or discharge, whichever was earlier. Secondary outcomes included comparing number of patients with bacteremia or clinical evidence of infection requiring antimicrobial therapy among the two groups. Results: We reviewed the charts of 116 LVAD patients and 134 CABG patients with median age 61 years [Interquartile Range (IQR) 53.0, 67.0] and BMI 28.4 kg/m2 [IQR 25.5, 32.8]. In the LVAD group, there was a peak in median WBC count to 14.2 (x103/ μL) [IQR 11.3, 17.6] on Day 2 post-operatively and another peak on Day 10 post-operatively to 14.1 [IQR 10.6, 18.4]. In the CABG group, median WBC peak was observed at Day 2 post-operatively at 11.8 [9.1, 14.2] (Fig. 1). There were 10 (8.6%) LVAD patients with clinical or microbiological evidence of infection compared to 2 (1.5%) CABG patients (p = 0.01). After excluding patients with infections there was no change observed in the trend of the postoperative WBC counts. Conclusion: Post-operative leukocytosis is common in cardiopulmonary bypass and peak WBC are higher in LVAD patients than CABG patients. WBC counts peak in LVAD patients at day 2 and 10 postoperatively. This expected peak should be taken into consideration while evaluating patients for infections and antimicrobial therapy.

Left Ventricular Assist Device Mode: Co-Pulse Left Ventricular Unloading in Working Mode of Ex Vivo Heart Perfusion

<h3>Purpose</h3> As normothermic ex vivo heart perfusion (EVHP), resting mode and working mode have been proposed. Herein we newly developed left ventricular assist device (LVAD) mode in EVHP: a novel EVHP mode that supported heart contraction by co-pulse synchronized LVAD. <h3>Methods</h3> Following resting mode at 0-1 hour, pig hearts (n = 18) were perfused using cellular perfusate in either of resting, working, and LVAD mode at 1-5 hour, and then myocardial function was evaluated in working mode in all cases at 6 hour. Preservation ratio in the evaluation was defined as myocardial function at 6 hour/myocardial function at 1 hour. Metabolic markers were measured every hour. In LVAD mode, LVAD unloaded the perfusate in left ventricle in systolic phase (Figure). <h3>Results</h3> LVAD mode group was significantly associated with higher preservation ratio in cardiac output (LVAD, 76 ± 5; Resting, 33 ± 3; Working, 35 ± 5%, P < 0.001), stroke work, dP/dt max, and dP/dt min, compared with other groups (Table). Glucose consumption were significantly reduced in resting mode group. LVAD mode group was associated with higher myocardial oxygen consumption (MVO₂) (LVAD, 6.1 ± 0.5; Resting, 2.2 ± 0.3; Working, 4.6 ± 0.5 mL O₂/mion/100g, P < 0.001) and higher ATP level (LVAD, 1.6 ± 0.2; Resting, 1.1 ± 0.1; Working, 0.7 ± 0.1 μmol/g, P = 0.003), compared with other groups. <h3>Conclusion</h3> These data suggest that myocardial function was better preserved in LVAD mode than in resting and working mode. Although similar glycolysis activity was suspected in LVAD and working groups, higher final ATP in LVAD group might be explained by reduced external work in LVAD.

Outcomes In Advance Heart Failure Patients With Biopsy Proven Liver Fibrosis

<h3>Background</h3> There is paucity of data regarding outcomes of stage D heart failure patients undergoing evaluation and treatment with advanced therapies [heart transplant (HTX), left ventricular assist device (LVAD)] in the setting of biopsy-proven liver fibrosis. <h3>Methods</h3> We retrospectively assessed stage D heart failure patients (age>18 years) who had liver biopsy and underwent advanced therapy evaluation from 2017 to 2020. Overall baseline characteristics and 1-year clinical outcomes were compared between mild to moderate (stage 0-2) and severe liver fibrosis (stage 3-4) group. <h3>Results</h3> A total of 136 patients were included. HTX was done in 23 patients, LVAD in 48 patients and 65 did not undergo advance therapies (no therapy group). Patients in no therapy group were older (61 vs 55 vs 57 years; p=0.03) and had more diabetes (60% vs 26% vs 46%; p=0.02) in comparison to HTX and LVAD group, respectively. Whereas HTX group had more non-ischemic cardiomyopathy (83% vs 65% vs 43%; p=0.02) compared to LVAD and no therapy group, respectively (Table 1A). Steatohepatitis was present in 26.1% of HTX, 31.3% of LVAD and 32.3% in no therapy group. Biopsies identified 23 patients with severe liver fibrosis and 113 patients with mild to moderate fibrosis. 1 LVAD patient lost follow-up in mild to moderate fibrosis group. Out of 23 patients in severe fibrosis group, 65% underwent no advanced therapies, only 4% underwent HTX and 30% received LVAD (Table1B). Among patients in the no therapy group, mean PCWP was higher in fibrosis grade 3-4 when compared to fibrosis grade 0-2 group (23 vs 17, p=0.04). No patient died in heart transplant group. There was no significant difference in 1-year mortality in LVAD group (43% vs 20%, p=0.2), whereas no therapy group showed high mortality (60% vs 26%, p=0.02) in severe fibrosis vs mild-moderate fibrosis patients (Tabe1B). The overall 1-year mortality among severe liver fibrosis patients who underwent no advanced therapy was 60% vs 37.5% with advanced therapies. <h3>Conclusions</h3> Liver fibrosis is common among advanced heart failure patients. Mortality is high in end-stage heart failure patients with underlying severe liver fibrosis. As anticipated, patients with severe liver fibrosis were less likely to undergo LVAD or HTX than patients with mild to moderate fibrosis. Therefore, liver biopsy should be considered in patients being evaluated for advanced therapies.

Outcomes of Heart Transplantation versus Left Ventricular Assist Device Implantation in Septuagenarians

Purpose Prior studies have separately evaluated outcomes of heart transplantation (HT) and left ventricular assist device (LVAD) implantation in elderly versus younger patients. The optimal advanced therapy strategy in septuagenarians is not well-characterized. We performed a retrospective study to evaluate the outcomes of HT and LVAD in septuagenarians with advanced heart failure. Methods Septuagenarians who received advanced therapies at UC San Diego between 2011 and 2021 were reviewed. We assessed in-hospital morbidity and long-term survival between patients who underwent HT versus LVAD. For survival analysis, septuagenarians who were declined advanced therapies were used as comparison. Results Of 78 patients who underwent advanced therapies, 22 patients received HT and 56 patients received LVAD. The HT group was younger (71.1 vs 73.9 years, p < 0.001) and more had temporary mechanical circulatory support prior to surgery (68.2% vs 16.1%, p < 0.001). While the LVAD group experienced more post-operative right ventricular failure (13.6% vs 57.1%, p < 0.001) and arrhythmia (18.1% vs 46.4%, p = 0.02), length of stay was comparable (24.2 vs 37.1 days, p = 0.19). In mean follow up of 2.2 years, there was no difference in survival between HT and LVAD patients (77.3% vs 64.3%, log-rank p = 0.419). Both strategies offered a survival benefit compared to patients who were declined advanced therapies (Figure; log-rank p = 0.009). Conclusion In a single-center cohort, septuagenarians who underwent advanced therapies with HT and LVAD derived significant survival benefit at two years. Patients with LVAD experienced higher in-hospital morbidity compared to HT. Prior studies have separately evaluated outcomes of heart transplantation (HT) and left ventricular assist device (LVAD) implantation in elderly versus younger patients. The optimal advanced therapy strategy in septuagenarians is not well-characterized. We performed a retrospective study to evaluate the outcomes of HT and LVAD in septuagenarians with advanced heart failure. Septuagenarians who received advanced therapies at UC San Diego between 2011 and 2021 were reviewed. We assessed in-hospital morbidity and long-term survival between patients who underwent HT versus LVAD. For survival analysis, septuagenarians who were declined advanced therapies were used as comparison. Of 78 patients who underwent advanced therapies, 22 patients received HT and 56 patients received LVAD. The HT group was younger (71.1 vs 73.9 years, p < 0.001) and more had temporary mechanical circulatory support prior to surgery (68.2% vs 16.1%, p < 0.001). While the LVAD group experienced more post-operative right ventricular failure (13.6% vs 57.1%, p < 0.001) and arrhythmia (18.1% vs 46.4%, p = 0.02), length of stay was comparable (24.2 vs 37.1 days, p = 0.19). In mean follow up of 2.2 years, there was no difference in survival between HT and LVAD patients (77.3% vs 64.3%, log-rank p = 0.419). Both strategies offered a survival benefit compared to patients who were declined advanced therapies (Figure; log-rank p = 0.009). In a single-center cohort, septuagenarians who underwent advanced therapies with HT and LVAD derived significant survival benefit at two years. Patients with LVAD experienced higher in-hospital morbidity compared to HT.

Impact of bridging with left ventricular assist device on right ventricular function following heart transplantation.

AimsPatients awaiting orthotopic heart transplantation (OHT) can be bridged utilizing a left ventricular assist device (LVAD) that reduces left ventricular filling pressures, decreases pulmonary artery wedge pressure, and maintains adequate cardiac output. This study set out to examine the poorly investigated area of if and how pre‐treatment with LVAD impacts right ventricular (RV) function following OHT.Methods and resultsWe prospectively evaluated 59 (LVAD n = 20) consecutive OHT patients. Transthoracic echocardiography (TTE) was performed in conjunction with right heart catheterization (RHC) at 1, 6, and 12 months after OHT. RV function TTE‐parameters included tricuspid annular plane systolic excursion (TAPSE), systolic tissue velocity (S′), fractional area change, two‐dimensional RV global longitudinal strain and longitudinal strain from the RV lateral wall (RVfree). At 1 month after OHT, the LVAD group had significantly better longitudinal RV function than the non‐LVAD group: TAPSE (15 ± 3 mm vs. 12 ± 2 mm, P < 0.001), RV global longitudinal strain (−19.8 ± 2.1% vs. −14.3 ± 2.8%, P < 0.001), and RVfree (−19.8 ± 2.3% vs. −14.1 ± 2.9%, P < 0.001). At this time point, pulmonary vascular resistance (PVR) was also lower [1.2 ± 0.4 Wood Units (WU) vs. 1.6 ± 0.6 WU, P < 0.05] in the LVAD group compared with the non‐LVAD group. At 6 and 12 months, no difference was detected in any of the TTE and RHC measured parameters between the two groups. Between 1 and 12 months, all parameters of RV function improved significantly in the non‐LVAD group but remained unaltered in the LVAD group.ConclusionsOur results indicate that pre‐treatment with LVAD decreases PVR and is associated with significantly better RV function early following OHT. During the first year following transplantation, RV function progressively improved in the non‐LVAD group such that at 6 and 12 months, no difference in RV function was detected between the groups.