Left Ventricular Assist Device Patients Research Articles

Performance of risk scores in predicting major bleeding in left ventricular assist device recipients: a comparative external validation

BackgroundImplantation of a left ventricular assist device (LVAD) is a crucial therapeutic option for selected end-stage heart failure patients. However, major bleeding (MB) complications postimplantation are a significant concern. ObjectivesWe evaluated current risk scores’ predictive accuracy for MB in LVAD recipients. MethodsWe conducted an observational, single-center study of LVAD recipients (HeartWare or HeartMate-3, November 2010-December 2022) in the Netherlands. The primary outcome was the time to first post-LVAD MB (according to the International Society on Thrombosis and Haemostasis [ISTH] and Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS], and INTERMACS combined with intracranial bleeding [INTERMACS+] criteria). Mortality prior to MB was considered a competing event. Discrimination (C-statistic) and calibration were evaluated for HAS-BLED, HEMORR2HAGES, Anticoagulation and Risk Factors in Atrial Fibrillation, Outpatient Bleeding Risk Index, VTE-BLEED, AF-BLEED, and Utah Bleeding Risk Score (UBRS). ResultsOne hundred four patients were included (median age, 64 years; female, 20.2%; HeartWare, 90.4%; HeartMate-3, 9.6%). The cumulative MB incidence was 75.7% (95% CI 65.5%-85.9%) by ISTH and INTERMACS+ criteria and 67.0% (95% CI 56.0%-78.0%) per INTERMACS criteria over a median event-free follow-up time of 1916 days (range, 59-4521). All scores had poor discriminative ability on their intended prediction timeframe. Cumulative area under the receiving operator characteristic curve ranged from 0.49 (95% CI 0.35-0.63, VTE-BLEED) to 0.56 (95% CI 0.47-0.65, UBRS) according to ISTH and INTERMACS+ criteria and from 0.48 (95% CI 0.40-0.56, Anticoagulation and Risk Factors in Atrial Fibrillation) to 0.56 (95% CI 0.47-0.65, UBRS) per INTERMACS criteria. All models showed poor calibration, largely underestimating MB risk. ConclusionCurrent bleeding risk scores exhibit inadequate predictive accuracy for LVAD recipients. There is a need for an accurate risk score to identify LVAD patients at high risk of MB who may benefit from patient-tailored antithrombotic therapy.

Alterations in Sarcopenia Index are Associated with Inflammation, Gut and Oral Microbiota among Heart Failure, Left Ventricular Assist Device and Heart Transplant Patients.

BackgroundSarcopenia, characterized by loss of muscle mass and function, is prevalent in heart failure (HF) and predicts poor outcomes. We investigated alterations in sarcopenia index (SI), a surrogate for skeletal muscle mass, in HF, left ventricular assist device (LVAD) and heart transplant (HT), and assessed its relationship with inflammation and digestive tract (gut and oral) microbiota. MethodsWe enrolled 460 HF, LVAD and HT patients. Repeated measures pre/post procedures were obtained prospectively in a subset of LVAD and HT patients. SI (serum Creatinine/Cystatin C) and inflammatory biomarkers (C-reactive protein, interleukin-6, tumor necrosis factor-alpha) were measured in 271 and 622 blood samples, respectively. Gut and saliva microbiota were assessed via 16S rRNA sequencing among 335 stool and 341 saliva samples. Multivariable regression assessed the relationship between SI and i) New York Heart Association class; ii) pre- vs. post-LVAD or HT; iii) biomarkers of inflammation and microbial diversity. ResultsMedian (interquartile range) natural logarithm (ln)-SI was -0.13 (-0.32,0.05). Ln-SI decreased across worsening HF class, further declined at 1-month after LVAD and HT and rebounded over time. Ln-SI was correlated with inflammation (r=-0.28, p<0.01), and gut (r=0.28, p<0.01) and oral microbial diversity (r=0.24, p<0.01), these associations remained significant after multivariable adjustment in the combined cohort but not for all individual cohorts. Presence of the gut taxa Roseburia inulinivorans was associated with increased SI. ConclusionsSI levels decreased in symptomatic HF and remained decreased long-term after LVAD and HT. In the combined cohort, SI levels covaried with inflammation in a similar fashion and significantly related to overall microbial (gut and oral) diversity, including specific taxa compositional changes.

Longitudinal cardiac dimensions in patients undergoing LVAD implantation.

In conventional left ventricular assist devices (LVAD), a separate outflow graft is sutured to the ascending aorta. Novel device designs may include a transventricular outflow cannula crossing the aortic valve (AV). While transversal ventricular dimensions are well investigated in patients with severe heart failure, little is known about the longitudinal dimensions. These dimensions are, however, particularly critical for the design and development of mechanical circulatory support (MCS) devices with transaortic outflow cannula. In an explorative retrospective cohort study at the University Medical Center Freiburg, Germany, the longitudinal cardiac dimensions of patients undergoing computed tomography angiography (CTA) before and, if available, after LVAD implantation were analyzed. Among others, the following dimensions were assessed: (a) apex to AV, (b) apex to mitral valve, (c) AV to sinotubular junction (STJ), (d) apex to STJ, (e) apex to brachiocephalic artery (BCA), and (f) AV to BCA. In total, 44 LVAD patients (36 male, age 55.8 years, height 1.75 m) were included. The longitudinal cardiac dimensions were (a) 114.5 ± 12.1 mm, (b) 108.0 ± 12.4 mm, (c) 20.9 ± 2.9, (d) 135.4 ± 13.4 mm, (e) 206.0 ± 18.3, and (f) 91.5 ± 9.8 mm. Postoperatively, (a) and (b) decreased by 31.5% and 39.5%, respectively (N = 14). Longitudinal cardiac dimensions may be reduced by up to 40% after LVAD implantation. A better knowledge of these dimensions and their postoperative alterations in LVAD patients may improve surgical planning and help to design MCS devices with transventricular outflow cannula.

Temporarily Reversing Warfarin With Low-Dose 4-Factor Prothrombin Complex Concentrate in Left Ventricular Assist Device Patients Undergoing an Invasive Procedure.

American Association for Thoracic Surgery and The International Society for Heart and Lung Transplantation (AATS/ISHLT) guidelines recommend warfarin in patients with continuous-flow left ventricular assist devices (LVADs) to reduce the risk of device thrombosis and systemic embolization. Left ventricular assist device patients often undergo elective and emergent procedures that require interrupted anticoagulation. Data and experience vary on the optimal strategy to rapidly reverse warfarin in LVAD patients when an emergent procedure is planned. The purpose of this study was to describe the use of 4-factor prothrombin complex concentrate (PCC4) for warfarin reversal in patients with LVADs undergoing elective and emergent procedures. This retrospective, single-center, cohort review describes the use of PCC4 in patients with LVADs who require warfarin reversal for elective or emergent procedures. The primary outcome was a composite incidence of pump thrombosis, venous thromboembolism, and ischemic stroke within 30 days of PCC4 administration. In total, 14 patients received 17 administrations of PCC4. One patient received 3 administrations, and 1 other patient received 2 administrations during separate encounters. The median dose was 500 units or 6.6 units/kg (range = 4.2-14.1 units/kg). Of the PCC4 administrations, 82% (14/17) were for low bleed risk procedures and 76% (13/17) were for elective procedures. There were no cases of pump thrombosis, venous thromboembolism, or stroke within 30 days of the procedure. Low-dose PCC4 appears to be a safe and effective temporary reversal strategy for patients with LVADs undergoing low-bleed risk elective procedures.

Apixaban in bridge to transplant and destination LVAD - rationale and study design: the ApixiVAD trial.

Use of novel anticoagulation in mechanical circulatory support is controversial. We report the rationale and design of the ApixiVad pilot trial, a pilot study testing the safety of apixaban as an anticoagulant in patients bridged to transplant (BTT) or for destination (DT) with Heartmate 3 (HM3) left ventricular assist device (LVAD). Apixaban has been used in small non-randomized cohorts in LVAD patients and shown to be effective in ex vivo studies. The ApixiVAD study examines apixaban use in a multicentre, international, open-label, randomized, controlled trial aiming to include 50 BTT or DT HM3 patients with a 1:1 randomization ratio. This event-driven study has a maximum follow-up period of 24months with interim analysis at 6months. The primary outcome is death, thromboembolic events and major bleeding, including operative bleeding and immediate transplant outcomes. The secondary outcome focuses on patients' quality of life related to anticoagulation. This investigator-driven pilot study is not powered to determine the non-inferiority of apixaban. An increase in primary outcome in the apixaban group of 20% will be considered a signal of harm. A positive outcome in the ApixiVAD study would provide the basis for future, larger, pivotal anticoagulation trials in LVAD patients.

Effectiveness of exercise-based cardiac rehabilitation for patients with left ventricular assist device: A systematic review and meta-analysis.

Exercise-based cardiac rehabilitation (EBCR) improves functional capacity in heart failure (HF). However, data on the effect of EBCR in patients with advanced HF and left ventricular assist devices (LVADs) are limited. This meta-analysis aimed to evaluate the impact of EBCR on the functional ability of LVAD patients by comparing the corresponding outcome indicators between the EBCR and ST groups. PubMed, Embase, Clinical Trials, and Cochrane Library databases were searched for studies assessing and comparing the effects of EBCR and standard therapy (ST) in patients following LVAD implantation. Using pre-defined criteria, appropriate studies were identified and selected. Data from selected studies were extracted in a standardized fashion, and a meta-analysis was performed using a fixed-effects model. The protocol was registered on INPLASY (202340073). In total, 12 trials involving 477 patients were identified. The mean age of the participants was 52.9 years, and 78.6% were male. The initiation of EBCR varied from LVAD implantation during the index hospitalization to 11months post-LVAD implantation. The median rehabilitation period ranged from 2weeks to 18months. EBCR was associated with improved peak oxygen uptake (VO2) in all trials. Quantitative analysis was performed in six randomized studies involving 214 patients (EBCR: n = 130, ST: n = 84). EBCR was associated with a significantly high peak VO2 (weighted mean difference [WMD] = 1.64mL/kg/min; 95% confidence interval [CI], 0.20-3.08; p = .03). Similarly, 6-min walk distance (6MWD) showed significantly greater improvement in the EBCR group than in the ST group (WMD = 34.54m; 95% CI, 12.47-56.42; p = .002) in 266 patients (EBCR, n = 140; ST, n = 126). Heterogeneity was low among the included trials. None of the included studies reported serious adverse events related to EBCR, indicating the safety of EBCR after LVAD implantation. This study demonstrated that EBCR following LVAD implantation is associated with greater improvement in functional capacity compared with ST as reflected by the improved peak VO2 and 6MWD values. Considering the small number of patients in this analysis, further research on the clinical impact of EBCR in LVAD patients is warranted.

Management of incessant ventricular arrhythmias in a patient with left ventricular assist device: a case report

BackgroundThe implantation of left ventricular assist devices (LVADs) as a bridge to transplantation or as destination therapy in end-stage heart failure patients is frequently complicated by the emergence of ventricular arrhythmias (VAs). These arrhythmias have been implicated in precipitating deleterious clinical outcomes, increased mortality rates and augmented healthcare expenditures.Case PresentationWe present a challenging case of a 49-year-old male with a history of dilated cardiomyopathy who received an LVAD. Post-implantation, the patient suffered from intractable VAs, leading to multiple rehospitalizations and hemodynamic deterioration. Despite exhaustive medical management and electrical cardioversion attempts, the patient’s VAs persisted, ultimately necessitating prioritization for cardiac transplantation.DiscussionThis case highlights the challenges in managing VAs in LVAD patients and the importance of multidisciplinary collaboration. While pharmacological intervention is the initial strategy, catheter ablation may be considered in selected cases when medication is insufficient. In instances of intractable VAs, expeditious listing for heart transplantation as a high-priority candidate is advisable when feasible.

(844) - Characterization and Treatment of Iron Deficiency in Left Ventricular Assist Device Patients

(844) - Characterization and Treatment of Iron Deficiency in Left Ventricular Assist Device Patients

(78) - Impact of Vitamin K Antagonist Therapy on Outcomes in a Randomized Controlled Trial of Aspirin Removal in Left Ventricular Assist Device Patients - A Pre-Specified Analysis from The ARIES Trial

(78) - Impact of Vitamin K Antagonist Therapy on Outcomes in a Randomized Controlled Trial of Aspirin Removal in Left Ventricular Assist Device Patients - A Pre-Specified Analysis from The ARIES Trial

(60) - Dynamic and Structural Ophthalmic Evaluation of Continuous-Flow Left Ventricular Assist Device Patients

(60) - Dynamic and Structural Ophthalmic Evaluation of Continuous-Flow Left Ventricular Assist Device Patients

(1308) - A Multidisciplinary Protocol for Anticoagulation Reversal in Left Ventricular Assist Device Patients Presenting with Intracranial Hemorrhage

(1308) - A Multidisciplinary Protocol for Anticoagulation Reversal in Left Ventricular Assist Device Patients Presenting with Intracranial Hemorrhage

(512) - Are the Bleeding and Thrombosis Complications in Left Ventricular Assist Device Patients as Impactful as Infection and Rejection in Heart Transplant Recipients?

(512) - Are the Bleeding and Thrombosis Complications in Left Ventricular Assist Device Patients as Impactful as Infection and Rejection in Heart Transplant Recipients?

(873) - Outcomes in HeartMate 3 Left Ventricular Assist Device Patients Requiring Temporary Right Ventricular Assist Device Support

(873) - Outcomes in HeartMate 3 Left Ventricular Assist Device Patients Requiring Temporary Right Ventricular Assist Device Support

(111) - Impact of Concomitant Surgical Procedures in a Randomized Controlled Trial of Aspirin Removal in Left Ventricular Assist Device Patients - An Analysis from The ARIES Trial

(111) - Impact of Concomitant Surgical Procedures in a Randomized Controlled Trial of Aspirin Removal in Left Ventricular Assist Device Patients - An Analysis from The ARIES Trial

(1079) - Clinician Assessed Versus Objective Measures of Frailty in Left Ventricular Assist Device Patients

(1079) - Clinician Assessed Versus Objective Measures of Frailty in Left Ventricular Assist Device Patients

Long-term quality of life, psychological distress, and caregiver burden in octogenarians with LVAD: A single-centre experience.

With the general population aging, both life expectancy and the number of left ventricular assist device (LVAD) implantations in elderly patients are growing. Nevertheless, their perceived long-term quality of life, including psychological aspects, coupled with the respective caregiver's burden, remain under-reported. In light of the rising number of octogenarians with LVAD who necessitate broader healthcare provider involvement, we assessed the long-term quality of life, as defined by both the 36-item short-form health (SF-36) survey and the EuroQol 5 dimensions, 5-level questionnaire (EQ-5D-5L)-including the visual analog scale-in octogenarian LVAD patients who had received treatment at our institution. Additionally, we evaluated the psychological health of octogenarian LVAD patients using the psychological general well-being index (PGWBI), alongside their caregivers' well-being through the 22-item version of the Zarit Burden Interview (ZBI). Of 12 octogenarian LVAD patients, 5 were alive and willing to answer questionnaires. Mean age at implant was 74 ± 2 years. Median follow-up was 2464 (IQR = 2375-2745) days. Although variable, the degree of health and psychological well-being perceived by octogenarian patients with LVAD was "good." Interestingly, the burden of assistance reported by caregivers, though relevant, was greatly varied, suggesting the need to better define and address psychological long-term aspects related to LVAD implantation for both patients and caregivers with a broad-spectrum approach.

Abstract P103: Alterations in Sarcopenia Index Are Associated With Inflammation, Gut and Oral Microbiota Among Heart Failure, Left Ventricular Assist Device and Heart Transplant Patients

Introduction: Sarcopenia, characterized by loss of muscle mass and function, is prevalent in heart failure (HF) and associated with poor outcomes. We investigated alterations in sarcopenia index (SI), a surrogate marker of skeletal muscle mass, in HF, left ventricular assist device (LVAD) and heart transplant (HT) and assessed its relationship with inflammation and digestive tract (gut and oral) microbiota. Hypothesis: Sarcopenia will be associated with increased inflammation, dysbiotic microbial signatures, higher HF class, and earlier time post-HT or post LVAD. Methods: We enrolled 460 HF, LVAD and HT patients. Repeated measures pre and post procedures were obtained in a subset of LVAD and HT patients. Sarcopenia index (serum Creatinine/Cystatin C) and inflammatory biomarkers (C-reactive protein, interleukin-6, tumor necrosis factor-alpha) were measured in 271 and 622 blood samples, respectively. Gut and saliva microbiota were assessed via 16S rRNA sequencing among 335 stool and 341 saliva samples. Multivariable regression models were used to assess the relationship between SI and i) New York Heart Association class; ii) pre- vs. post-LVAD or HT; iii) biomarkers of inflammation and microbial diversity. Results: Median (interquartile range) ln-SI was -0.13(-0.32,0.05). Ln-SI decreased across worsening HF class, further declined within the 1-month after LVAD and HT and rebounded over time to the levels of symptomatic HF. Ln-SI demonstrated an inverse correlation with inflammation (r=-0.28, p&lt;0.0001), and a positive correlation with gut (r=0.26, p&lt;0.0001) and oral microbial diversity (r=0.24, p&lt;0.0001). Presence of the gut taxa Roseburia inulinivorans was associated with increased SI. Conclusions: SI levels decreased in symptomatic HF and remained decreased long-term after LVAD and HT. SI levels covaried with inflammation, gut and oral microbiota in a similar fashion.

The Influence of Arrhythmias and Metabolic Profile on Inpatient Mortality in Patients with Left Ventricular Assist Devices.

Background: In patients with end-stage heart failure, durable Left Ventricular Assist Devices (LVADs) can be used as a bridge to transplant or destination therapy. LVADs have been shown to improve survival for patients with heart failure (HF). HF is associated with electrolyte abnormalities and the development of sustained arrhythmias. However, data on the influence of arrhythmias and electrolyte imbalances on inpatient outcomes in LVAD patients are lacking. Furthermore, previous works assessing inpatient outcomes focused mainly on the role of chronic comorbidities in those outcomes. Methods: In this cross-sectional study, we used discharge data from the National Inpatient Sample from 2019 to 2020 to assess the influence of acute arrhythmias on inpatient mortality in patients with LVADs. We also investigated the relationship between acute medical conditions and mortality. Results: There were 9418 (not survey-adjusted) hospitalizations with LVAD, among which 2539 (27%) died during the hospitalization. Univariate analysis of arrhythmias showed that ventricular arrhythmias (VAs)-ventricular fibrillation/flutter and ventricular tachycardia-as well as complete heart block were associated with significantly higher odds of mortality. Follow-up multivariable logistic analysis showed that these arrhythmias retain their increased association with death. Hyperkalemia and acidosis had increased adjusted odds of death (1.54 (95% confidence interval: 1.28-1.85) (p < 0.001) and 2.44 (CI: 2.14-2.77) (p < 0.001), respectively). Conclusions: VAs, complete heart block, hyperkalemia, and acidosis were associated with increased odds of all-cause mortality. Females had higher odds of inpatient mortality. These findings suggest that electrolyte management, maintenance of optimal acid-base balance, and interventions to treat sustained ventricular arrhythmias may be suitable therapeutic targets to reduce mortality in hospitalized patients with LVADs.

Socio-economic position, multimorbidity, and health care utilization among Danish left ventricular assist device patients.

Increasing numbers of patients with advanced heart failure and significant comorbidity and social barriers are considered for left ventricular assist devices (LVADs). We sought to examine health care utilization post-LVAD implantation, including the influence of individual-level socio-economic position and multimorbidity. We conducted a Danish nationwide cohort study linking individual-level data from clinical LVAD databases, the Scandiatransplant Database, and Danish national medical and administrative registries. Socio-economic position included cohabitation status, educational level, and employment status. Multimorbidity was defined as two or more chronic conditions from at least two chronic disease groups. Health care utilization (hospital activity, general practice activity, and redeemed medical prescriptions) within 2years post-discharge after LVAD implantation was evaluated using descriptive statistics at 0.5year intervals. We identified 119 patients discharged alive with first-time LVAD implanted between 2006 and 2018. The median age of the patients was 56.1years, and 88.2% were male. Patients were followed until heart transplantation, LVAD explantation, death, 31 December 2018, or for 2years. The median follow-up was 0.8years. The highest median use of health care services was observed 0-0.5years post-LVAD discharge compared with the subsequent follow-up intervals: 0.5-1, 1-1.5, and 1.5-2years, respectively. The median (interquartile range) number of hospitalizations was 10 (7-14), bed days 14 (9-28), outpatient visits 8 (5-12), telephone contacts with a general practitioner 4 (2-8), and total redeemed medical prescriptions 26 (19-37) within 0-0.5years post-LVAD discharge compared with the median utilization within the consecutive follow-up periods [e.g. within 0.5-1year: hospitalizations 5 (3-8), bed days 8 (4-14), outpatient visits 5 (3-8), telephone contacts 2 (0-5), and redeemed medical prescriptions 24 (18-30)]. The median use of health care services was stable from 0.5years onwards. The median number of hospitalizations and bed days was slightly higher in patients living alone with a low educational level or low employment status within 0-0.5years post-LVAD implantation. Finally, the median number of in-hospital days and redeemed prescriptions was higher among patients with pre-existing multimorbidity. Among patients who underwent LVAD implantation, health care utilization was high in the early post-LVAD discharge phase and was influenced by socio-economic position. Multimorbidity influenced the number of in-hospital days and redeemed prescriptions during the 2year follow-up.

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.