Left Ventricular Assist Device Implantation Research Articles

Use of Levosimendan in patients with INTERMACS 3 profile: weaning from inotropic support and short- to medium-term evolution

Abstract Funding Acknowledgements None. Introduction Patients with advanced heart failure (HF) in cardiogenic shock (CS) present a markedly high mortality rate. For CS patients dependent on inotropes, management is difficult with few therapeutic options available, especially in the absence of a suitability for heart transplantation (HTX) or left ventricular assist device implantation (LVAD), thus associating an even worse prognosis. Purpose With our study we aim to analyse the rate of weaning from inotropic support when Levosimendan, a calcium sensitizer with positive inotropic effects, is used in INTERMACS 3 CS patients and their short to medium-term evolution. We then evaluate if the absence of right ventricular dysfunction, of renal dysfunction, non-ischemic aetiology and QRS width could be predicting factors of a successful weaning from inotropes. Materials and methods We conducted a monocentric retrospective analysis of patients from a tertiary cardiac intensive care unit that have received a 24 hours Levosimendan infusion in the context of INTERMACS 3 cardiogenic shock between August 2015 – April 2023. Results Of the 137 subjects included in the analysis, 62 patients received Levosimendan for INTERMACS 3 CS. The median age was 59±15.3 and 91.9% (n=57) were male. Baseline LVEF was 19±6%, cardiac index 1.67±0.4L/min/m2, median NTproBNP 13 378 ± 11 126ng/L. 51.6% (n=32) had ischemic heart disease and 40.3% (n=25) had dilated cardiomyopathy. After Heart Team discussion, only 37% (n=23) were considered eligible for HTX or LVAD. Successful inotrope weaning was experienced in 68% (n=42). Amongst patients with weaning failure, most outcomes resulted in either death (45%), ambulatory continuous Dobutamine infusion (30%), or benefited from a HTX if eligible (15%). The weaning failure rates were similar amongst patients eligible and non-eligible to HTX or LVAD with different outcomes after weaning failure as shown in Figure 1. The overall survival rates at 1 month and 6 months were of 83.8% and 53.2% respectively, with a significant difference between survival rates according to inotrope weaning success or failure as shown in Figure 2. We found no clinical, biological, or echocardiographic parameter to be significantly associated with an increased probability of weaning. Conclusion Levosimendan use in INTERMACS 3 CS patients provides a good rate of success in weaning from inotropic support and could be a useful tool in allowing treatment optimization and stabilization in non HTX or LVAD eligible patients, as well as being a "bridge to transplantation" alternative. No predicting factors for successful weaning have been identified.

A prospective multicenter feasibility study of a miniaturized implantable continuous flow ventricular assist device in smaller children with heart failure

There is no FDA-approved left ventricular assist device (LVAD) for smaller children permitting routine hospital discharge. Smaller children supported with LVADs typically remain hospitalized for months awaiting heart transplant-a major burden for families and a challenge for hospitals. We describe the initial outcomes of the Jarvik 2015, a miniaturized implantable continuous flow LVAD, in the NHLBI-funded Pumps for Kids, Infants, and Neonates (PumpKIN) study, for bridge-to-heart transplant. Children weighing 8 to 30 kg with severe systolic heart failure and failing optimal medical therapy were recruited at 7 centers in the United States. Patients with severe right heart failure and single-ventricle congenital heart disease were excluded. The primary feasibility endpoint was survival to 30 days without severe stroke or non-operational device failure. Of 7 children implanted, the median age was 2.2 (range 0.7, 7.1) years, median weight 10 (8.2 to 20.7) kilograms; 86% had dilated cardiomyopathy; 29% were INTERMACS profile 1. The median duration of Jarvik 2015 support was 149 (range 5 to 188) days where all 7 children survived including 5 to heart transplant, 1 to recovery, and 1 to conversion to a paracorporeal device. One patient experienced an ischemic stroke on day 53 of device support in the setting of myocardial recovery. One patient required ECMO support for intractable ventricular arrhythmias and was eventually transplanted from paracorporeal biventricular VAD support. The median pump speed was 1600 RPM with power ranging from 1-4 Watts. The median plasma free hemoglobin was 19, 30, 19 and 30 mg/dL at 7, 30, 90 and 180 days or time of explant, respectively. All patients reached the primary feasibility endpoint. Patient-reported outcomes with the device were favorable with respect to participation in a full range of activities. Due to financial issues with the manufacturer, the study was suspended after consent of the eighth patient. The Jarvik 2015 LVAD appears to hold important promise as an implantable continuous flow device for smaller children that may support hospital discharge. The FDA has approved the device to proceed to a 22-subject pivotal trial. Whether this device will survive to commercialization remains unclear because of the financial challenges faced by industry seeking to develop pediatric medical devices. (Supported by NIH/NHLBI HHS Contract N268201200001I, clinicaltrials.gov 02954497).

ECPELLA as abridge-to-decision in refractory cardiogenic shock: asingle-centre experience.

In refractory cardiogenic shock, temporary mechanical support (tMCS) may be crucial for maintaining tissue perfusion and oxygen delivery. tMCS can serve as abridge-to-decision to assess eligibility for left ventricular assist device (LVAD) implantation or heart transplantation, or as abridge-to-recovery. ECPELLA is anovel tMCS configuration combining venoarterial extracorporeal membrane oxygenation with Impella. The present study presents the clinical parameters, outcomes, and complications of patients supported with ECPELLA. All patients supported with ECPELLA at University Medical Centre Utrecht between December 2020 and August 2023 were included. The primary outcome was 30-day mortality, and secondary outcomes were LVAD implantation/heart transplantation and safety outcomes. Twenty patients with an average age of 51years, and of whom 70% were males, were included. Causes of cardiogenic shock were acute heart failure (due to acute coronary syndrome, myocarditis, or after cardiac surgery) or chronic heart failure, respectively 70and 30% of cases. The median duration of ECPELLA support was 164 h (interquartile range 98-210). In 50% of cases, apermanent LVAD was implanted. Cardiac recovery within 30days was seen in 30% of cases and 30-day mortality rate was 20%. ECPELLA support was associated with major bleeding (40%), haemolysis (25%), vascular complications (30%), kidney failure requiring replacement therapy (50%), and Impella failure requiring extraction (15%). ECPELLA can be successfully used as abridge to LVAD implantation or as abridge-to-recovery in patients with refractory cardiogenic shock. Despite asignificant number of complications, 30-day mortality was lower than observed in previous cohorts.

Driveline Infection in Patients With Left Ventricular Assist Devices Implanted as Destination Therapy

Donor organ shortages cause increasing demand for mechanical circulatory support in patients with end-stage heart failure not only as a bridge to heart transplantation but mainly as a destination therapy. Improved results and increased applicability and durability of left ventricular assist devices (LVADs) have established this treatment option as an alternative to heart transplantation in selected patients. One of the most common complications after LVAD implantation is driveline infections (DLIs). This study aimed to expand the understanding of DLI epidemiology and potential changes in implantation techniques regarding optimizing DLI prevention and treatment among all patients undergoing LVAD (Medtronic's Heartware HVAD and HeartMate 3 Abbott LVAD system) implantation with at least 12 months of follow-up time between 2015 and 2022. There were 120 individuals with LVAD implantation, of whom 90 had 12 months of follow-up (85 men [94%], 5 women [6%]) with a median age of 58 years (50.25-63.75). The median body mass index was 27.12 kg/m2 (25.27-29.68). Of the 90 patients, 43 had ischemic heart failure (48%), 43 had dilated cardiomyopathy (48%), and the remaining 3 had other etiologies (3%), such as postinflammatory, and the remaining 1 had congenital heart defect (1%). Preoperative echocardiography revealed a mean left ventricle ejection fraction of 13.8% and a median left ventricle dimension of 7.55 cm (6.92-8.2). Imaging confirmed pulmonary hypertension in 61 patients (68%). Thirty-four of the 90 patients had diabetes (38%), and 16 were active smokers (18%). Median follow-up was 30 months (17.25-42), with the longest period being 82 months. More than half of the patients (n = 52; 57%) experienced a DLI. The median time to the first episode of DLI was 13 months (6-25). The most common pathogen revealed in wound swab culture was methicillin-sensitive Staphylococcus aureus (n = 23; 44%), Pseudomonas aeruginosa (n = 9; 17%), Proteus mirabilis (n = 4; 7%), and others. We observed that deeper driveline implantation below the left rectus muscle and just above the posterior rectus sheath resulted in fewer DLIs and longer free-from-DLI follow-up time. There was no statistically significant difference in DLI frequency between patients with or without diabetes mellitus. Appropriate selection of candidates and timing of LVAD implantation are critical for improved outcomes of destination therapy. DLI is the most common complication after LVAD implantation. Optimal surgical techniques and early implementation of targeted antibiotics are crucial. Significant challenges remain in optimizing DLI prevention and treatment.

Outcomes and Complications after Left Ventricular Assist Device Implantation

Heart transplantation is the treatment of choice for selected patients with end-stage heart failure. Persistent donor organ shortage causes a growing demand for mechanical circulatory support not only as a bridge to transplantation but mainly as a destination therapy (DT). The aim of the study was to analyze the indications, comorbidities, and complications during the follow-up of all patients undergoing left ventricular assist device (LVAD) implantation with at least 12 months of follow-up time in one of the most experienced clinics in Poland between 2015 and 2023. There were 125 individuals with LVAD implantation, from which 90 had full 12 months of follow-up (85 males - 94%, 5 females - 6%), with a median age of 58 (50.25-63.75) years. The median body mass index was 27.12 (25.27-29.68). The etiology of heart failure was ischemic (n = 44, 49%), dilated cardiomyopathy (n = 44, 49%), and others. Preoperative echocardiography revealed a mean LV ejection fraction of 13.8% and a median LV dimension of 7.55 (6.92-8.2) cm. In 61 patients (68%), imaging confirmed pulmonary hypertension. Thirty-four patients (38%) had diabetes and 16 (18%) were active smokers. Median follow-up was 30 (17.25-42) months, with the longest period being about 82 months. 40 (44%) patients had kidney failure before LVAD implantation, and in 43 cases (48%), we observed relevant, transient deterioration of kidney function. Almost all patients (n = 82, 91%) suffered from anemia (Hb <13 g/dL in males and <12 g/dL in females) in different periods after LVAD implantation due to perioperative bleeding, gastrointestinal bleeding or unknown causes. The lowest Hb level was observed in the first week after LVAD implantation in 53 cases (58%). Median red cell concentrate transfusion demand before the discharge after surgery was 6 (2-8, 5) units. Appropriate selection of candidates and timing of LVAD implantation are critical for improved outcomes of DT. Anemia and kidney failure are the most frequent follow-up complications. Improved results and increased applicability and durability of LVADs have established this treatment option as an excellent alternative for patients with end-stage heart failure.

Prognostic implications of delirium after Left Ventricular Assist Device (LVAD) implantation: A retrospective study

IntroductionIn critically ill patients, delirium is a prognostic indicator of morbidity and mortality. This study investigates the impact of a delirium diagnosis on outcomes after Left Ventricular Assist Device (LVAD) implantation. MethodsThis retrospective study included all adult patients who received LVADs at our institution between January 2016 and December 2020. We compared pre-implantation characteristics between the two groups, with and without a diagnosis of delirium, and compared their outcomes, including 1-month, 6-month, and in-hospital mortality, as well as re-intubation rate, length of stay (LOS), discharge disposition, and readmission rates. ResultsIn total, 361 patients (26.7% women, 75.8% African American) received durable LVADs. Ninety-four patients (26.1%) were diagnosed with delirium during the index admission. Pre-implantation demographic characteristics, past medical and psychiatric conditions, Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile, and laboratory values did not differ between the two groups with and without a diagnosis of delirium; older age (59 vs 56; P=0.03) was associated with delirium. Delirium diagnosis was associated with higher 1-month (P=0.007), 6-month (P=0.004), and in-hospital mortality (P<0.001), unplanned re-intubations (P<0.001), and a lower likelihood of discharge home (P = 0.03). Total hospital and ICU LOS were higher in patients with a diagnosis of delirium, though these results were not statistically significant. Readmission to hospital after index admission was quicker in patients with a diagnosis of delirium, but this result was not statistically significant. ConclusionsIn this study, a diagnosis of delirium during the LVAD implantation admission was associated with higher mortality, adverse post-surgical outcomes, and unfavorable discharge dispositions. Future prospective research is needed to validate the prognostic implications of delirium in both the short and long term. Additionally, there is a need to identify modifiable risk factors associated with delirium to promote early diagnosis and implement evidence-based management strategies to enhance outcomes within this population.

D-9 | Choice of temporary mechanical circulatory support in patients undergoing left ventricular assist device implantation

D-9 | Choice of temporary mechanical circulatory support in patients undergoing left ventricular assist device implantation

Predictors and Impact of Prolonged Vasoplegia After Continuous-Flow Left Ventricular Assist Device Implantation

BackgroundVasoplegia after cardiac surgery is associated with adverse outcomes. However, the clinical effects of vasoplegia and the significance of its duration after continuous-flow left ventricular assist device (CF-LVAD) implantation are less known. ObjectivesThis study aimed to identify predictors of and outcomes from transient vs prolonged vasoplegia after CF-LVAD implantation. MethodsThe study was a retrospective review of consecutive patients who underwent CF-LVAD implantation between January 1, 2005, and December 31, 2017. Vasoplegia was defined as the presence of all of the following: mean arterial pressure ≤65 mm Hg, vasopressor (epinephrine, norepinephrine, vasopressin, or dopamine) use for >6 hours within the first 24 hours postoperatively, cardiac index ≥2.2 L/min/m2 and systemic vascular resistance <800 dyn/s/cm5, and vasodilatory shock not attributable to other causes. Prolonged vasoplegia was defined as that lasting 12 to 24 hours; transient vasoplegia was that lasting 6 to <12 hours. Patient characteristics, outcomes, and risk factors were analyzed. ResultsOf the 600 patients who underwent CF-LVAD implantation during the study period, 182 (30.3%) developed vasoplegia. Mean patient age was similar between the vasoplegia and no-vasoplegia groups. Prolonged vasoplegia (n = 78; 13.0%), compared with transient vasoplegia (n = 104; 17.3%), was associated with greater 30-day mortality (16.7% vs 5.8%; P = 0.02). Risk factors for prolonged vasoplegia included preoperative dialysis and elevated body mass index. ConclusionsCompared with vasoplegia overall, prolonged vasoplegia was associated with worse survival after CF-LVAD implantation. Treatment to avoid or minimize progression to prolonged vasoplegia may be warranted.

Evaluation of the Hemocompatibility of the Direct Oral Anticoagulant Apixaban in Left Ventricular Assist Devices (DOAC LVAD) Study

BackgroundPatients receiving left ventricular assist device (LVAD) support require long-term anticoagulation to reduce the risk of thromboembolic complications. Apixaban is a direct oral anticoagulant that has become first-line therapy; however, its safety in LVAD recipients has not been well described. ObjectivesThis study sought to investigate whether, in patients with a fully magnetically levitated LVAD, treatment with apixaban would be feasible and comparable with respect to safety and freedom from the primary composite outcome of death or major hemocompatibility-related adverse events (HRAEs) (stroke, device thrombosis, major bleeding, aortic root thrombus, and arterial non–central nervous system thromboembolism) as compared with treatment with warfarin. MethodsThe DOAC LVAD (Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices) trial was a phase 2, open label trial of LVAD recipients randomized 1:1 to either apixaban twice daily or warfarin therapy. All patients were required to take low-dose aspirin. Patients were followed up for 24 weeks to evaluate the primary composite outcome. ResultsA total of 30 patients were randomized: 14 to warfarin and 16 to apixaban. The median patient age was 60 years (Q1-Q3: 52-71 years), and 47% were Black patients. The median time from LVAD implantation to randomization was 115 days (Q1-Q3: 56-859 days). At 24 weeks, the primary composite outcome occurred in no patients receiving apixaban and in 2 patients (14%) receiving warfarin (P = 0.12); these 2 patients experienced major bleeding from gastrointestinal sources. ConclusionsAnticoagulation with apixaban was feasible in patients with an LVAD without an excess of HRAEs or deaths. This study informs future pivotal clinical trials evaluating the safety and efficacy of apixaban in LVAD recipients. (Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices [DOAC LVAD]; NCT04865978)

Enhancing the implantation of mechanical circulatory support devices using computational simulations.

Introduction: Patients with end-stage heart failure (HF) may need mechanical circulatory support such as a left ventricular assist device (LVAD). However, there are a range of complications associated with LVAD including aortic regurgitation (AR) and thrombus formation. This study assesses whether the risk of developing aortic conditions can be minimised by optimising LVAD implantation technique. Methods: In this work, we evaluate the aortic flow patterns produced under different geometrical parameters for the anastomosis of the outflow graft (OG) to the aorta using computational fluid dynamics (CFD). A three-dimensional aortic model is created and the HeartMate III OG positioning is simulated by modifying (i) the distance from the anatomic ventriculo-arterial junction (AVJ) to the OG, (ii) the cardinal position around the aorta, and (iii) the angle between the aorta and the OG. The continuous LVAD flow and the remnant native cardiac cycle are used as inlet boundaries and the three-element Windkessel model is applied at the pressure outlets. Results: The analysis quantifies the impact of OG positioning on different haemodynamic parameters, including velocity, wall shear stress (WSS), pressure, vorticity and turbulent kinetic energy (TKE). We find that WSS on the aortic root (AoR) is around two times lower when the OG is attached to the coronal side of the aorta using an angle of 45° ± 10° at a distance of 55mm. Discussion: The results show that the OG placement may significantly influence the haemodynamic patterns, demonstrating the potential application of CFD for optimising OG positioning to minimise the risk of cardiovascular complications after LVAD implantation.

[Prognostic performance of pulmonary effective arterial elastance in patients with heart failure].

Objective: To explore the predictive value of pulmonary effective arterial elastance (Ea) in patients with heart failure (HF). Methods: This is a retrospective cohort study, which retrospectively included 284 patients with HF who underwent right heart catheterization at Heart Failure Center in Fuwai Hospital between September 2013 and February 2022. Data regarding baseline clinical characteristics, hemodynamic profiles, and prognosis were collected. Ea was calculated as mean pulmonary arterial pressure/stroke volume. Patients were divided into Ea<0.555 group and Ea≥0.555 group according to the median value of Ea (0.555 mmHg/ml, 1 mmHg=0.133 kPa). The primary outcome was the primary clinical event, set as the first occurrence of a series of composite events, including all-cause death, heart transplantation, left ventricular assist device implantation, and HF rehospitalization. Event-free survival was defined as the absence of primary clinical events. Spearman correlation analysis was used to calculate the correlation coefficient between Ea and parameters reflective of right heart function. The Kaplan-Meier analysis was used to compare the different groups for the estimation of outcomes with the log-rank test. We used Cox proportional-hazards regression models to estimate hazard ratios (HR) for primary clinical event. Subgroup analysis was performed based on the age, gender, New York Heart Association (NYHA) functional class, left ventricular ejection fraction, presence of pulmonary hypertension, and serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) values. We used receiver operating characteristic (ROC) curve to calculate the area under the curve (AUC) of Ea for predicting event-free survival in patients with HF. Results: The median age was 51 years, and 206 (72.5%) patients were male. Ea and pulmonary vascular resistance (PVR) were significantly correlated (r=0.698, P<0.001). The correlation between Ea and pulmonary arterial elastance (PAC) were even more significant (r=-0.888, P<0.001). Compared with Ea<0.555 group, Ea≥0.555 group presented with higher serum NT-proBNP values (4 443 (1 792, 8 554) ng/L vs. 1 721 (480, 4 528)ng/L,P<0.001), higher PVR (3.4 (2.5, 4.7) Wood vs. 1.4 (0.9, 2.2) Wood, P<0.001), lower cardiac output (3.0 (2.3, 3.9) L/min vs. 4.3 (3.8, 4.9) L/min, P<0.001), and lower PAC (1.6 (1.3, 2.0) ml/mmHg vs. 4.0 (3.0, 6.0) ml/mmHg, P<0.001). The median follow-up time was 392 (166, 811) days. The Kaplan-Meier survival curve demonstrated a lower event-free survival rate in the Ea≥0.555 group compared to the Ea<0.555 group (Plog-rank<0.001). After multivariate adjustment, Ea (HR=1.734, P<0.001) remained significantly associated with the primary outcome. Subgroup analysis indicated that Ea was associated with the primary outcome across all subgroups. The AUC was 0.724 (P<0.001) for Ea to predict event-free survival calculated from ROC analysis. Conclusions: Ea is closely related to parameters reflective of right ventricular afterload. Increased Ea is an independent predictor of adverse outcomes in patients with HF.

Escalating Surgical Treatment for Left Ventricular Assist Device Infection and Expected Mortality: Clinical Risk Prediction Score.

Left ventricular assist devices (LVAD) improve survival for patients with cardiac failure, but LVAD specific infections (VSI) remain a challenge with poorly understood predictive risk factors. Furthermore, the indications and utility of escalating medical treatment to surgical debridement and potential flap reconstruction are not well-characterized. A retrospective review of consecutive patients undergoing primary LVAD implantation at a tertiary academic center was performed. The primary outcomes measures were 90-day and overall mortality after VSI. Cox proportional hazards regression was used to generate a risk-prediction score for mortality. Of the 760 patients undergoing primary LVAD implantation, 255 (34%) developed VSI; of these 91 (36%) were managed medically, 134 (52%) with surgical debridement, and 30 (12%) with surgical debridement and flap reconstruction. One-year survival after infection was 85% with median survival of 2.40 years. Factors independently associated with increased mortality were diabetes (hazard ratio (HR) 1.44, p=0.04), methicillin-resistant Staphylococcus aureus infection (HR 1.64, p=0.03), deep space (pump pocket/outflow cannula) involvement (HR 2.26, p<0.001) and extra-corporeal membrane oxygenation after LVAD (HR 2.52, p<0.01. Factors independently associated with decreased mortality were flap reconstruction (HR 0.49, p=0.02) and methicillin-sensitive Staphylococcus aureus infection (HR 0.63, p=0.03). A clinical risk prediction score was developed using these factors and showed significant differences in median survival, which was 5.67 years for low-risk (score 0-1), 3.62 years for intermediate-risk (score 2), and 1.48 years for high-risk (score >3) (p<0.001) patients. We developed a clinical risk prediction score to stratify VSI patients. In selected cases, escalating surgical treatment was associated with increased survival. Future work is needed to determine if early surgical debridement and flap reconstruction can alter outcomes in select cases of VSI.

Temporal Analysis in Outcomes of Long-Term Mechanical Circulatory Support: Retrospective Study.

Mechanical assist device indications have changed in recent years. Reduced incidence of complications, better survival, and the third generation of mechanical support devices contributed to this change. In this single-center study, we focused on two time periods that are characterized by the use of different types of mechanical support devices, different patient characteristics, and change in the indications. The data were processed from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). We retrospectively defined two time intervals to reflect changes in ventricular assist device technology (period 1: 2007-2015; period 2: 2016-20222). A total of 181 patients underwent left ventricular assist device implantation. Device utilization was the following: HeartMate II = 52 (76.4%) and HeartWare = 16 (23.6%) in period 1 and HeartMate II = 2 (1.8%), HeartMate 3 = 70 (61:9%), HeartWare = 29 (25.7%), SynCardia TAH = 10 (8.8%), and BerlinHeart EXCOR = 2 (1.8%) in period 2. The outcomes of the time intervals were analyzed and evaluated. Survival was significantly higher during the second time period. Multivariate analysis revealed that age and bypass pump time are independent predictors of mortality. Idiopathic cardiomyopathy, bypass time, and the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) score are independent predictors of adverse events. Furthermore, the first period was noted to be at an increased risk of the following adverse events: pump thrombosis, gastrointestinal bleeding, and bleeding events. Despite the higher risk profile of the patients and persistent challenges, during the second period, there was a significant decrease in mortality and morbidity. The use of the HeartMate 3 device may have contributed to this result.

Noncardiac Surgery in Patients with Left Ventricular Assist Devices: A 11-Year Institutional Experience.

Limited options in the end-stage treatment of heart failure have led to increased use of left ventricular assist devices. For this reason, the rate of non-cardiac surgeries in patients with left ventricular assist devices is also increasing. Our study aims to analyze surgical rate, anesthesia management, and results by reviewing our 11-year experience with patients who underwent non-cardiac surgery receiving left ventricular assist devices support. We retrospectively evaluated 57 patients who underwent non-cardiac surgery and 67 non-cardiac surgical procedures among 274 patients who applied between January 2011 and December 2022 and underwent left ventricular assist devices implantation with end-stage heart failure. Fifty (74.6%) patients with left ventricular assist devices admitted to the hospital for non-cardiac surgery were emergency interventions. The most common reasons for admission were general surgery (52.2%), driveline wound revision (22.3%), and neurological surgery (14.9%). This patient group has the highest in-hospital mortality rate (12.8%) and the highest rate of neurological surgery (8.7%). While 70% of the patients who underwent neurosurgery were taken to surgery urgently, the International Normalized Ratio values of these patients were between 3.5 and 4.5 at the time of admission to the emergency department. With a perioperative multidisciplinary approach, higher morbidity and mortality risks can be reduced during emergencies and major surgical procedures.

Influence of the Outflow Graft Angular Position on the Outcomes in Patients With a Left Ventricular Assist Device.

This study aimed to explore the potential impact of the angular position of the outflow graft on thromboembolic events and aortic valve regurgitation in people with a left ventricular assist device (LVAD). We analyzed contrast computed tomography (CT) data of patients with LVAD implantation between 2016 and 2021. Three-dimensional reconstructions of the outflow graft and aortic arch were performed to calculate the horizontal (azimuth) angle and vertical (polar) angle, as well as the relative distance between the outflow graft, aortic valve, and brachiocephalic artery. Among 59 patients (median age 57, 68% male), a vertical angle ≥107° correlated significantly with increased cerebrovascular accidents (hazard ratio [HR]: 5.8, 95% confidence interval [CI]: 1.3-26.3, p = 0.022) and gastrointestinal bleeding (HR: 3.4, 95% CI: 1.0-11.2, p = 0.049) during a median 25 month follow-up. No significant differences were found between the vertical angle and aortic valve regurgitation or survival. The horizontal angle and relative distance did not show differences regarding clinical adverse events. This study emphasizes the importance of the LVAD outflow graft angular position to prevent life-threatening thromboembolic events. This study suggests the need for prospective research to further validate these findings.

Electrical storm after left ventricular assist device (LVAD) implantation.

Ventricular tachycardia storm or electrical storm (ES) is a common complication following left ventricular assist device (LVAD) implantation. The factors contributing to ES and outcomes are less studied. The study aimed to determine the factors associated with ES and the probability of survival in patients undergoing LVAD in three tertiary centers over a span of 15 years. We performed a retrospective cohort study on all patients who underwent LVAD implantation at the Mayo Clinic (Rochester, Phoenix, and Jacksonville) from January 1, 2006to December 31, 2020. ES was defined as ≥3 episodes of sustained ventricular tachycardia over a period of 24 h with no identifiable reversible cause. Detailed chart reviews of the electronic health records within the Mayo Clinic and outside medical records were performed. A total of 883 patients who underwent LVAD implantation were included in our study. ES occurred in 7% (n = 61) of patients with a median of 13 days (interquartile range [IQR]: 5-297 days) following surgery. We found 57% of patients (n = 35) developed ES within 30 days, while 43% (n = 26) patients developed ES at a median of 545 (IQR 152-1032) days after surgery. Following ES, 26% of patients died within 1 year. Patients with ES had a significant association with a history of ventricular arrhythmias and implantable cardioverter defibrillator(ICD) shocks before the procedure. ES was significantly associated with reduced survival compared to patients without ES(hazards ratio [HR]: 1.92, 95% CI: 1.39-2.64, p < .001). Following LVAD implantation, the rate of ES was 7% with majority of ES occurring within 30 days of LVAD. Risk factors for ES included pre-implant history of ventricular arrhythmias and ICD shock. ES was significantly associated with reduced survival compared to patients without ES.

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.

Outcomes of left ventricular assist device implantations at Karolinska University Hospital: A retrospective study

ObjectiveTo descriptively present data and outcomes of Left ventricular assist device (LVAD) implantations at Karolinska University hospital. MethodsData were collected from consecutive patients (n=44) who were implanted with HeartMate 3 (HM3) at Karolinska University Hospital between 2017 and 2022. The study presents baseline characteristics, clinical course during the inpatient hospital care after implantation, adverse events, and clinical outcomes. ResultsMedian intensive care unit stay and hospital stay after HM3 implantation was 8 (interquartile range [IQR] 6; 15) and 28 days (IQR 22; 36), respectively. In total, 73% underwent ramp test at some point after the implantation. Death from all causes within 30 days post-implantation was 5%. A total of 21 patients (48%) underwent right heart catheterization, at a median of 0.5 years (IQR 0.3;0.7) after implantation, and all exhibited optimally unloaded left ventricles. During the study period, 34% of the patients were transplanted, 5% were explanted, and 16% died with LVAD. In total, 11% and 5% suffered from early and late right ventricle failure, respectively. Acute renal failure affected 46% and 18% had drive-line infection. Spontaneous cerebral haemorrhage and cerebral infarction affected 5% and 7% of the study population, respectively. Gastrointestinal bleeding affected 16%. The median LVAD-duration was 10 months (IQR 5;22). The one-year survival rate with LVAD was 85%, and the two-year survival rate was 80%. ConclusionsThe results of this low volume single-center retrospective study on LVAD implantations align with the results of other studies and international registries.

Association of Psychosocial Risk Factors With Quality of Life and Readmissions 1 Year After LVAD Implantation

BackgroundAmong patients with advanced heart failure (HF), treatment with a left ventricular assist device (LVAD) improves health-related quality of life (HRQOL). We investigated the association between psychosocial risk factors, HRQOL, and outcomes after LVAD implantation. MethodsA retrospective cohort (n=9832) of adults aged ≥ 19 years who received durable LVAD between 2008 – 2017 was identified using the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Patients were considered to have psychosocial risk factors if ≥1 of the following were present: 1) substance abuse; 2) limited social support; 3) limited cognitive understanding; 4) repeated non-adherence; and 5) major psychiatric disease. Multivariable logistic and linear regression models were used to evaluate the association between psychosocial risk factors and change in Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 scores from baseline to 1-year, persistently poor HRQOL (KCCQ-12 score < 45 at baseline and 1-year), and 1-year rehospitalization. ResultsAmong the final analytic cohort, 2024 (20.6%) patients had ≥1 psychosocial risk factors. Patients with psychosocial risk factors were associated with a smaller improvement in KCCQ-12 scores from baseline to 1-year (Mean ± SD, 29.1 ± 25.9 vs 32.6 ± 26.1, p=0.015) for a difference of -3.51 (95% confidence interval [CI]: -5.88 to -1.13). Psychosocial risk factors were associated with persistently poor HRQOL (adjusted odds ratio [aOR] 1.35, 95% confidence interval [CI] 1.04 – 1.74), and 1-year all-cause readmission (adjusted hazard ratio [aHR] 1.11, 95% CI 1.05 – 1.18). Limited social support, major psychiatric disorder, and repeated non-adherence were associated with persistently poor HRQOL, while major psychiatric disorder was associated with 1-year rehospitalization. ConclusionThe presence of psychosocial risk factors is associated with lower KCCQ-12 scores and higher risk for readmission at 1-year after LVAD. While these associations are statistically significant, further research is needed to determine whether these differences are clinically meaningful.

(874) - Usefulness of Established Risk Scores in Predicting Right Heart Failure Requiring Temporary Right Ventricular Assist Device Support Following Left Ventricular Assist Device Implantation

(874) - Usefulness of Established Risk Scores in Predicting Right Heart Failure Requiring Temporary Right Ventricular Assist Device Support Following Left Ventricular Assist Device Implantation