Ventricular Assist Device Recipients Research Articles

Structural heart transcatheter interventions in orthotopic cardiac transplant and left ventricular assist devices recipients: A nationwide study

BackgroundThe current incidence and outcomes of structural transcatheter procedures in heart transplant (HTx) recipients and left-ventricular assist devices (LVAD) carriers is unknown.Aims: To provide insights on structural transcatheter procedures performed across HTx and LVAD patients in Spain. MethodsMulticenter, ambispective, observational nationwide registry. ResultsUntil May/2023, 36 percutaneous structural interventions were performed (78% for HTx and 22% for LVAD) widely varying among centers (0%–1.4% and 0%–25%, respectively). Percutaneous mitral transcatheter edge-to-edge (TEER) was the most common (n = 12, 33.3%), followed by trancatheter aortic valve replacement (n = 11, 30.5%), and tricuspid procedures (n = 9, 25%).Mitral TEER resulted in mild residual mitral regurgitation in all but one case, mean gradient was <5 mmHg in 75% of them at 1-year, with no mortality and 8.3% re-admission rate. Tricuspid TEER resulted in 100% none/mild residual regurgitation with a 1-year mortality and readmission rates of 22% and 28.5%, respectively. Finally, trancatheter aortic valve replacement procedures (n = 8 in LVADs due to aortic regurgitation and n = 3 in HTx), were successful in all cases with one prosthesis degeneration leading to severe aortic regurgitation at 1-year, 18.2% mortality rate and no re-admissions.Globally, major bleeding rates were 7.9% and 12.5%, thromboembolic events 3.7% and 12.5%, readmissions 37% and 25%, and mortality 22% and 25%, in HTx and LVADs respectively. No death was related to the implanted transcatheter device. ConclusionsMost centers with HTx/LVAD programs perform structural percutaneous procedures but with very inconsistent incidence. They were associated with good safety and efficacy, but larger studies are required to provide formal recommendations.

Structural heart transcatheter interventions in orthotopic cardiac transplant and left ventricular assist devices recipients: A nationwide study

BackgroundThe current incidence and outcomes of structural transcatheter procedures in heart transplant (HTx) recipients and left-ventricular assist devices (LVAD) carriers is unknown.Aims: To provide insights on structural transcatheter procedures performed across HTx and LVAD patients in Spain. MethodsMulticenter, ambispective, observational nationwide registry. ResultsUntil May/2023, 36 percutaneous structural interventions were performed (78% for HTx and 22% for LVAD) widely varying among centers (0%–1.4% and 0%–25%, respectively). Percutaneous mitral transcatheter edge-to-edge (TEER) was the most common (n = 12, 33.3%), followed by trancatheter aortic valve replacement (n = 11, 30.5%), and tricuspid procedures (n = 9, 25%).Mitral TEER resulted in mild residual mitral regurgitation in all but one case, mean gradient was <5 mmHg in 75% of them at 1-year, with no mortality and 8.3% re-admission rate. Tricuspid TEER resulted in 100% none/mild residual regurgitation with a 1-year mortality and readmission rates of 22% and 28.5%, respectively. Finally, trancatheter aortic valve replacement procedures (n = 8 in LVADs due to aortic regurgitation and n = 3 in HTx), were successful in all cases with one prosthesis degeneration leading to severe aortic regurgitation at 1-year, 18.2% mortality rate and no re-admissions.Globally, major bleeding rates were 7.9% and 12.5%, thromboembolic events 3.7% and 12.5%, readmissions 37% and 25%, and mortality 22% and 25%, in HTx and LVADs respectively. No death was related to the implanted transcatheter device. ConclusionsMost centers with HTx/LVAD programs perform structural percutaneous procedures but with very inconsistent incidence. They were associated with good safety and efficacy, but larger studies are required to provide formal recommendations.

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 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 the Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly score, Hepatic or Renal Disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Re-Bleeding, Hypertension, Anemia, Genetic Factors, Excessive Fall Risk and Stroke score, Anticoagulation and Risk Factors in Atrial Fibrillation score, Outpatient Bleeding Risk Index, venous thromboembolism score, atrial fibrillation score, 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, venous thromboembolism-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.

(241) - Clinical Outcomes and the Impact of SCAI Stage Among Protekduo Right Ventricular Assist Device Recipients with Cardiogenic Shock: A Report from the Cardiogenic Shock Working Group

(241) - Clinical Outcomes and the Impact of SCAI Stage Among Protekduo Right Ventricular Assist Device Recipients with Cardiogenic Shock: A Report from the Cardiogenic Shock Working Group

(576) - Assessment of Platelet Response to Aspirin Therapy and Hemocompatibility-Related Adverse Events in HeartMate 3 Left Ventricular Assist Device Recipients

(576) - Assessment of Platelet Response to Aspirin Therapy and Hemocompatibility-Related Adverse Events in HeartMate 3 Left Ventricular Assist Device Recipients

(457) - Adverse In-Hospital Outcomes of Left Ventricular of Ventricular Assist Device Recipients Developing Acute Kidney Injury

(457) - Adverse In-Hospital Outcomes of Left Ventricular of Ventricular Assist Device Recipients Developing Acute Kidney Injury

(811) - Left Ventricular Assist Device Recipients with a History of Cardiovascular Disease or Cardiothoracic Surgery Have Increased Mortality

(811) - Left Ventricular Assist Device Recipients with a History of Cardiovascular Disease or Cardiothoracic Surgery Have Increased Mortality

Epidemiology and Risk Factors for Nosocomial Infections in Left Ventricular Assist Device Recipients.

Left ventricular assist devices (LVADs) have been increasingly used as a valid option to improve the prognosis and reduce the symptoms of end-stage heart failure. However, long-term complications, mostly infections and coagulation disorders, are frequent. We described the epidemiology and risk factors for nosocomial infections (NIs) in a cohort of adult patients who underwent continuous-flow LVAD implant between January 2010 and December 2017 in Turin, Italy. Secondary outcomes were the prevalence of multidrug-resistant (MDR) bacteria and mortality. Results: Overall, 64 LVADs were implanted. A total of 32 (50%) patients experienced at least one episode of NI, with a total of 46 infectious events. VAD-related infections occurred in 22 patients (68.8%). Non VAD-related NIs occurred in 12 patients (37.5%), mainly low respiratory tract infections. Length of intensive care unit admission was a risk factor for NI (OR 1.224, 95%CI; 1.049, 1.429). Gram-negative bacilli were responsible for 58.8% of VAD-related infections and 79.5% of non-VAD related infections. In sixteen patients (50%), at least one episode of infection was related to an MDR strain. INTERMACS class and length of MV were independent risk factors for NIs by MDR strains (respectively, OR 2.12, 95%CI: 1.08, 6.80; p = 0.02 and OR 1.46, 95%CI: 1.07, 5.52, p = 0.047). In-hospital mortality was 6.3%. No differences in mortality were observed between infected and non-infected patients (p = 0.61) even when caused by MDR strains (p = 0.143). Conclusion: the rate of nosocomial infections in LVAD patients is associated with the length of ICU admission, and the etiology of nosocomial infection after LVAD implant is mainly due to GNB, including a high rate of MDR strains, especially KPC-KP and MDR PA.

Pre- and Post-Implant Endoscopy in Left Ventricular Assist Device Recipients: A Single-Center Experience.

Gastrointestinal bleeding (GIB) is common in left ventricular assist devices (LVADs) patients, but the optimal screening approach before LVAD implantation is still unclear. The aim of the study was to describe our experience with pre- and post-LVAD implantation endoscopic screening and subsequent GI bleeding in this cohort. A retrospective review was conducted among all patients who underwent LVAD implantation at Saint Luke's Hospital, between 2010 and 2020. The data were reviewed to determine the yield and safety of endoscopic procedures performed within 1 month before LVAD placement and the incidence of GIB within 1 year after implantation. A total of 167 LVAD patients met the inclusion criteria, and 23 underwent pre-implantation endoscopic evaluation. Angiodysplasia had a significantly higher odds ratio (OR) of 9.41 (95% confidence interval (CI): 2.01 - 44.09) in post-LVAD endoscopy, while there was no significant difference in bleeding from other sources such as peptic ulcer disease or diverticular bleeding. There was no difference in the incidence of GIB in patients who underwent endoscopic evaluation pre-LVAD compared to post-LVAD GIB (32.6% vs. 39.1%, P = 0.64). Endoscopy was well-tolerated in this cohort, and argon plasma coagulation was the most commonly used intervention to achieve hemostasis. According to our results, we recommend against routine pre-LVAD endoscopic screening. Instead, we suggest an individualized approach, where decisions are made on a case-by-case basis.

Differences in early outcomes for left ventricular assist device recipients implanted before and during the COVID-19 pandemic.

Differences in early outcomes for left ventricular assist device recipients implanted before and during the COVID-19 pandemic.

Perioperative Management And Episode Of Care Outcomes Following Hip Or Knee Arthroplasty Among Left Ventricular Assist Device Recipients

Perioperative Management And Episode Of Care Outcomes Following Hip Or Knee Arthroplasty Among Left Ventricular Assist Device Recipients

Intravenous administration of umbilical cord lining stem cells in left ventricular assist device recipients: Results of the uSTOP LVAD BLEED pilot study

PurposeLeft ventricular assist device (LVAD) implantation improves survival in advanced heart failure. Despite this, angiodysplastic bleeding complications remain a significant driver of costs as well as morbidity. Mechanisms implicated in post LVAD implant bleeding include the dysregulation of angiogenic factors seen in this population. The present pilot study evaluates the safety of umbilical cord lining stem cells (ULSCs) in LVAD recipients while exploring any early evidence of efficacy to improve bleeding. MethodsIn a 3 + 3 design, 9 patients received an intravenous (IV) infusion of ULSCs at escalating doses. The primary endpoint was safety and tolerability, secondary exploratory outcomes included antibodies against hemoglobin to quantify the amount of blood in stool without need for dietary restriction. ResultsThe primary safety and tolerability outcomes were met as no infusion related adverse events or toxic responses were observed. There was no sensitization after administration of ULSCs as assessed by panel reactive antibody. An increase in Angiopoetin-1 levels and a decrease in Angiopoetin-2 levels from baseline to 30 days were observed in 4 patients. Quantitative Faecal Immunochemical Test suggested a decrease in the mean blood content of stool from baseline to 30 days. ConclusionsIn this first ever IV administration of ULSCs in LVAD patients, infusion was noted to be safe and tolerable and did not cause immune sensitization. Half of the patients were noted to have angiogenic stabilization, and there was a trend towards decreasing amounts of blood noted in the stool, suggesting an early signal of efficacy.

Exploring Liposomal Systems for Gallic Acid and Tannic Acid Delivery: Potential Strategies to Address Inflammation and Infections in Pediatric Ventricular Assist Device Recipients

Exploring Liposomal Systems for Gallic Acid and Tannic Acid Delivery: Potential Strategies to Address Inflammation and Infections in Pediatric Ventricular Assist Device Recipients

Catheter Ablation for Tachyarrhythmias in Left Ventricular Assist Device Recipients: Clinical Significance and Technical Tips.

The demand for durable left ventricular assist devices (LVADs) has been increasing worldwide in tandem with the rising population of advanced heart failure patients. Especially in cases of destination therapy, instead of bridges to transplantation, LVADs require a lifelong commitment. With the increase in follow-up periods after implantation and given the lack of donor hearts, the need for managing concomitant tachyarrhythmias has arisen. Atrial and ventricular arrhythmias are documented in approximately 20% to 50% of LVAD recipients during long-term device support, according to previous registries. Atrial arrhythmias, primarily atrial fibrillation, generally exhibit good hemodynamic tolerance; therefore, catheter ablation cannot be easily recommended due to the risk of a residual iatrogenic atrial septal defect that may lead to a right-to-left shunt under durable LVAD supports. The clinical impacts of ventricular arrhythmias, mainly ventricular tachycardia, may vary depending on the time periods following the index implantation. Early occurrence after the operation affects the hospitalization period and mortality; however, the late onset of ventricular tachycardia causes varying prognostic impacts on a case-by-case basis. In cases of hemodynamic instability, catheter ablation utilizing a trans-septal approach is necessary to stabilize hemodynamics. Nonetheless, in some cases originating from the intramural region or the epicardium, procedural failure may occur with the endocardial ablation. Specialized complications associated with the state of LVAD support should be carefully considered when conducting procedures. In LVAD patients, electrophysiologists, circulatory support specialists, and surgeons should collaborate as an integrated team to address the multifaceted issues related to arrhythmia management.

Abstract 16780: Single Cell Profiles of Human Heart Failure and Myocardial Diseases

Background: Heart failure represents the end-stage of a range of diseases which adversely impact the heart muscle. The extent by which cellular and molecular mechanisms differ between myocardial diseases in heart failure remains incompletely understood. Methods: We performed isolation and droplet-based RNA-sequencing of 394 247 single nuclei from 103 explanted hearts from transplant and ventricular assist device recipients and 7 unused donor hearts without heart disease. After sample and nuclei level quality control, doublet removal and sample integration; principal component analysis and shared nearest neighbor clustering were used to identify distinct cell populations. Cell type composition and transcriptomic profiles were compared across donor hearts and 10 myocardial diseases (hypertrophic, dilated, ischemic, restrictive, arrythmogenic and non-compaction cardiomyopathy; rheumatic and congenital heart disease; cardiac amyloidosis and graft rejection; n=1-45/group). Results: We identified and manually annotated 14 distinct cell populations that were present across controls and myocardial diseases, including transcriptionally diverse subgroups of cardiomyocytes, endothelial cells and pericytes. Compared to controls, we observed disease-specific differences in cell populations with regards to composition, heterogeneity, and specific transcriptional profiles. Conclusions: Our results reveal differences in single cell profiles of individual heart muscle diseases compared to controls without heart disease.

Abstract 12859: Clinical Correlates and Prognostic Value of B-type Natriuretic Peptide in Left Ventricular Assist Device Recipients With Cardiogenic Shock: Insights From INTERMACS

Introduction: B-type natriuretic peptide (BNP) is a robust predictor of outcomes across the heart failure (HF) spectrum. However, data characterizing BNP levels in end-stage HF with cardiogenic shock (CS) is lacking. Furthermore, the prognostic value of BNP in left ventricular assist device (LVAD) receiving Stage D HF patients with CS has not been assessed previously. Methods: Continuous flow LVAD recipients with CS enrolled in INTERMACS between 2005 to 2017 were included. CS was defined as INTERMACS profile 1-3. The primary outcome of the study was long-term mortality. Long-term mortality was assessed in patients alive at 1-month post-surgery. Secondary outcomes included peri-operative mortality (&lt;30 days of surgery), cardiovascular mortality, arrhythmia, and right HF. The cohort was stratified by quartiles of BNP levels. Multivariable Cox proportional hazard models, adjusted for age, sex, body mass index, INTERMACS profile, center volume, implantation year, device strategy, estimated glomerular filtration rate, employment status, and education level, were used to assess the association between BNP levels and outcomes. Results: Among 7,290 LVAD recipients with CS, the median pre-implantation BNP value was 859 (427, 1,614) pg/mL. Males [851(429, 1,557) pg/mL, P =0.07], non-Hispanic Blacks [777 (362, 1,514) pg/mL, P =&lt;0.001], and obese [642 (311, 1,170) pg/mL, P =&lt;0.001] patients had lower BNP values. Over a median follow-up of 14.7 (6.9, 28.7) months, the risk of long-term mortality was similar in the second [HR adj :1.06 (0.94-1.20)], third [HR adj :0.97 (0.85-1.10)], and fourth [HR adj :1.04 (0.91-1.18)] quartiles of BNP compared with the first quartile of BNP. Similarly, the risk of peri-operative mortality, cardiovascular mortality, arrhythmia, and right HF did not vary by the quartiles of BNP. Conclusions: BNP has poor prognostic value in LVAD recipients with CS and the value of routine measurement of BNP in this population needs further investigation.

Kidney Function Trajectories, Risk Factors, and Outcomes in Left Ventricular Assist Device (LVAD) Recipients

Kidney Function Trajectories, Risk Factors, and Outcomes in Left Ventricular Assist Device (LVAD) Recipients

Clinical Correlates and Prognostic Value of B-Type Natriuretic Peptide in Left Ventricular Assist Device Recipients With Cardiogenic Shock: Insights from INTERMACS

Clinical Correlates and Prognostic Value of B-Type Natriuretic Peptide in Left Ventricular Assist Device Recipients With Cardiogenic Shock: Insights from INTERMACS

Comparison of the course of SARS-CoV-2 infection in left ventricular assist device recipients implanted before and during COVID-19 pandemic.

Comparison of the course of SARS-CoV-2 infection in left ventricular assist device recipients implanted before and during COVID-19 pandemic.

Cardiac Cachexia in Left Ventricular Assist Device Recipients and the Implications of Weight Gain Early After Implantation.

Background Severe cardiac cachexia or malnutrition are commonly considered relative contraindications to left ventricular assist device (LVAD) implantation, but post-LVAD prognosis for patients with cachexia is uncertain. Methods and Results Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) 2006 to 2017 was queried for the preimplantation variable cachexia/malnutrition. Cox proportional hazards modeling examined the relationship between cachexia and LVAD outcomes. Of 20 332 primary LVAD recipients with available data, 516 (2.54%) were reported to have baseline cachexia and had higher risk baseline characteristics. Cachexia was associated with higher mortality during LVAD support (unadjusted hazard ratio [HR], 1.36 [95% CI, 1.18-1.56]; P<0.0001), persisting after adjustment for baseline characteristics (adjusted HR, 1.23 [95% CI, 1.0-1.42]; P=0.005). Mean weight change at 12 months was +3.9±9.4 kg. Across the cohort, weight gain ≥5% during the first 3 months of LVAD support was associated with lower mortality (unadjusted HR, 0.90 [95% CI, 0.84-0.98]; P=0.012; adjusted HR, 0.89 [95% CI, 0.82-0.97]; P=0.006). Conclusions The proportion of LVAD recipients recognized to have cachexia preimplantation was low at 2.5%. Recognized cachexia was independently associated with higher mortality during LVAD support. Early weight gain ≥5% was independently associated with lower mortality during subsequent LVAD support.