Durable Left Ventricular Assist Device Research Articles

Changes in Donor Utilization and Outcomes for Patients Bridged With Durable Left Ventricular Assist Device.

We studied the impact of the 2018 heart allocation policy change on donor characteristics and posttransplant outcomes of left ventricular assist device (LVAD)-bridged heart transplant (HT) recipients. Left ventricular assist device-bridged adult HT recipients from October 2014 to October 2022 in the United Network for Organ Sharing database were categorized into old allocation policy (OAP) and new allocation policy (NAP) cohorts. Baseline characteristics, posttransplant outcomes, and subgroup analyses of unstable and stable LVAD-bridged recipients were assessed. The study included 7,384 HT recipients; 4,345 (58.8%) were transplanted in the OAP era and 3,039 (41.2%) in the NAP era. Old allocation policy recipients were most frequently status 1A at transplantation (71.1%), whereas NAP recipients were most frequently status 3 (40.0%), and status 4 (31.9%). Median donor sequence number (DSN) was higher in the NAP versus OAP era (9 vs. 3, p < 0.001). On multivariable analysis, NAP recipients had 20% higher 1 year mortality compared to OAP (adjusted hazard ratio [aHR] = 1.20 [95% confidence interval {CI}: 1.04-1.40], p = 0.01). Status 1 or 2 recipients had 28% higher 1 year mortality compared to status 1A (aHR = 1.28 [95% CI: 1.01-1.63], p = 0.04). Status 1 and 2 LVAD-supported recipients had higher mortality following the 2018 allocation change, indicating the need for closer surveillance of LVAD-bridged patients who may decompensate on the waitlist.

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.

Comparison of Intraoperative Blood Product Use During Heart Transplantation in Patients Bridged with Impella 5.5 versus Durable Left Ventricular Assist Devices

Comparison of Intraoperative Blood Product Use During Heart Transplantation in Patients Bridged with Impella 5.5 versus Durable Left Ventricular Assist Devices

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.

Special Considerations for Advanced Heart Failure Surgeries: Durable Left Ventricular Devices and Heart Transplantation.

Heart transplantation and durable left ventricular assist devices (LVADs) represent two definitive therapies for end-stage heart failure in the modern era. Despite technological advances, both treatment modalities continue to experience unique risks that impact surgical and perioperative decision-making. Here, we review special populations and factors that impact risk in LVAD and heart transplant surgery and examine critical decisions in the management of these patients. As both heart transplantation and the use of durable LVADs as destination therapy continue to increase, these considerations will be of increasing relevance in managing advanced heart failure and improving outcomes.

Early Outcomes in Patients With LVAD Undergoing Heart Transplant via Use of the SherpaPak Cardiac Transport System.

Heart transplant (HT) in recipients with left ventricular assist devices (LVADs) is associated with poor early post-HT outcomes, including primary graft dysfunction (PGD). As complicated heart explants in recipients with LVADs may produce longer ischemic times, innovations in donor heart preservation may yield improved post-HT outcomes. The SherpaPak Cardiac Transport System is an organ preservation technology that maintains donor heart temperatures between 4 °C and 8 °C, which may minimize ischemic and cold-induced graft injuries. This analysis sought to identify whether the use of SherpaPak versus traditional cold storage was associated with differential outcomes among patients with durable LVAD undergoing HT. Global Utilization and Registry Database for Improved Heart Preservation-Heart (NCT04141605) is a multicenter registry assessing post-HT outcomes comparing 2 methods of donor heart preservation: SherpaPak versus traditional cold storage. A retrospective review of all patients with durable LVAD who underwent HT was performed. Outcomes assessed included rates of PGD, post-HT mechanical circulatory support use, and 30-day and 1-year survival. SherpaPak (n=149) and traditional cold storage (n=178) patients had similar baseline characteristics. SherpaPak use was associated with reduced PGD (adjusted odds ratio, 0.56 [95% CI, 0.32-0.99]; P=0.045) and severe PGD (adjusted odds ratio, 0.31 [95% CI, 0.13-0.75]; P=0.009), despite an increased total ischemic time in the SherpaPak group. Propensity matched analysis also noted a trend toward reduced intensive care unit (SherpaPak 7.5±6.4 days versus traditional cold storage 11.3±18.8 days; P=0.09) and hospital (SherpaPak 20.5±11.9 days versus traditional cold storage 28.7±37.0 days; P=0.06) lengths of stay. The 30-day and 1-year survival was similar between groups. SherpaPak use was associated with improved early post-HT outcomes among patients with LVAD undergoing HT. This innovation in preservation technology may be an option for HT candidates at increased risk for PGD. URL: https://www.clinicaltrials.gov; Unique identifier: NCT04141605.

Temporary Mechanical Circulatory Support During Bariatric Surgery: A Novel Bridge to Durable Left Ventricular Assist Device and Cardiac Transplantation.

Advanced heart failure (HF) with comorbid severe obesity presents a unique surgical dilemma: bariatric surgery may help patients meet cardiac transplantation body mass index (BMI) criteria, but poor cardiac function puts them at increased intraoperative risk. Per International Society for Heart and Lung Transplantation (ISHLT) guidelines BMI > 35 is a contraindication for orthotopic heart transplantation. Temporary mechanical circulatory support (MCS) with Impella 5.5 during bariatric surgery, as presented in this report, may help solve this dilemma for some patients. We present three patients with severe obesity and advanced heart failure (HF) who underwent successful bariatric surgery while supported by Impella 5.5 (Abiomed, Inc., Danvers, MA).

(109) - Incidence and Risk Factors for Early Stroke Following Durable Left Ventricular Assist Device (LVAD) Implantation: An STS Intermacs Analysis

(109) - Incidence and Risk Factors for Early Stroke Following Durable Left Ventricular Assist Device (LVAD) Implantation: An STS Intermacs Analysis

(32) - Long-Term Outcomes of Substance Abusers Who Received a Durable Left Ventricular Assist Device (LVAD)

(32) - Long-Term Outcomes of Substance Abusers Who Received a Durable Left Ventricular Assist Device (LVAD)

(62) - Sildenafil Modifies Platelet Activation and Reduces Mediators of Vascular Remodeling During Durable Left Ventricular Assist Device Support: A Double-Blind, Placebo-Controlled, Randomized Study

(62) - Sildenafil Modifies Platelet Activation and Reduces Mediators of Vascular Remodeling During Durable Left Ventricular Assist Device Support: A Double-Blind, Placebo-Controlled, Randomized Study

(190) - Utility of CardioMEMS HF System Data in Management of Patients Supported with Durable Left Ventricular Assist Devices (INTELLECT 3-HF Study)

(190) - Utility of CardioMEMS HF System Data in Management of Patients Supported with Durable Left Ventricular Assist Devices (INTELLECT 3-HF Study)

(823) - Hemodynamic Effects of Pacing in Patients with Durable Left Ventricular Assist Devices (LVAD)

(823) - Hemodynamic Effects of Pacing in Patients with Durable Left Ventricular Assist Devices (LVAD)

(951) - Effectiveness of Pump Exchange for Major Device Related Infection in Patients Receiving a Durable Left Ventricular Assist Device

(951) - Effectiveness of Pump Exchange for Major Device Related Infection in Patients Receiving a Durable Left Ventricular Assist Device

(338) - Sex-Specific Differences in Outcomes of Patients Weaned from Durable Left Ventricular Assist Devices (LVAD) - A VAD Wean Registry Analysis

(338) - Sex-Specific Differences in Outcomes of Patients Weaned from Durable Left Ventricular Assist Devices (LVAD) - A VAD Wean Registry Analysis

(1289) - Acclimation of Right Ventricular Function After Durable Left Ventricular Assist Device Support

(1289) - Acclimation of Right Ventricular Function After Durable Left Ventricular Assist Device Support

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.

Impella as Bridge to Durable Left Ventricular Assist Device in Acute Myocardial Infarction Cardiogenic Shock Patients.

Implantation of durable left ventricular assist device (LVAD) in cardiogenic shock (CS) patients after acute myocardial infarction (AMI) poses specific challenges (small left ventricular size, acute infarct area, need for antithrombotic therapy, status Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) 1 with impaired organ function and derangements in coagulation and inflammatory parameters) which may affect outcomes. We reviewed data of all AMI-CS patients who were implanted LVAD after Impella support at a referral center with the aim to analyze feasibility, timing, and outcomes of durable LVAD implantation after tMCS with Impella due to AMI-CS. Twenty-one patients were treated between 2013 and 2023: all were in Society for Cardiovascular Angiography & Interventions (SCAI) class D-E and INTERMACS 1-2 at presentation, median LV ejection fraction (EF) and LV end-diastolic diameter (EDD) were 15 (10-20)% and 57 (54-60) mm, respectively. Eleven patients (52%) were supported with Impella CP, seven with Impella 5.0 (33%), and three (14%) with Impella 2.5. Axillary cannulation was performed in nine patients (43%). Five patients (24%) had concomitant venoarterial extracorporeal membrane oxygenation (VA-ECMO) support. Median duration of Impella support was 12 (8-14) days. Overall, the use of Impella was characterized by low rate of complications and allowed successful bridge to durable LVAD in all patients, with 100% 30 day survival rate.

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.

Right Ventricular Assist Device Placement During Left Ventricular Assist Device Implantation Is Associated With Improved Survival.

Right ventricular failure (RVF) is a significant cause of mortality in patients undergoing left ventricular assist device (LVAD) implantation. Although right ventricular assist devices (RVADs) can treat RVF in the perioperative LVAD period, liberal employment before RVF is not well established. We therefore compared the survival outcomes between proactive RVAD placement at the time of LVAD implantation with a bailout strategy in patients with RVF. Retrospectively, 75 adult patients who underwent durable LVAD implantation at our institution and had an RVAD placed proactively before LVAD implantation or as a bailout strategy postoperatively due to hemodynamically unstable RVF were evaluated. Patients treated with a proactive RVAD strategy had lower Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) and a higher proportion of these required temporary mechanical circulatory support (MCS) preoperatively. Preoperative hemodynamic profiling showed a low pulmonary artery pulsatility index (PAPi) score of 1.8 ± 1.4 and 1.6 ± 0.94 (p = 0.42) in the bailout RVAD and proactive RVAD groups, respectively. Survival at 3, 6, and 12 months post-LVAD implantation was statistically significantly higher in patients who received a proactive RVAD. Thus, proactive RVAD implantation is associated with short- and medium-term survival benefits compared to a bailout strategy in RVF patients undergoing LVAD placement.

Incidence, Outcomes, and Opportunity for Left Ventricular Assist Device Weaning for Myocardial Recovery

BackgroundMyocardial recovery occurs in patients with advanced heart failure on left ventricular assist device (LVAD) support, but there is the premise that it is rare with uncertain results. ObjectivesThe goal of this study was to investigate the incidence and consequence of LVAD explant after myocardial recovery. MethodsUsing the United Network for Organ Sharing registry, LVAD implants in the United States between 2005 and 2020 were tracked until death, transplantation, or explant for myocardial recovery. The cohort undergoing explant was followed up for heart failure relapse (defined as relisting followed by delisting due to death, being too ill, or transplantation; or second durable LVAD implant). ResultsOf 15,728 LVAD implants, 126 patients underwent explant for recovery, which only occurred in 55 (38%) of 145 implanting centers. The crude cumulative incidence was 0.7% at 2 years, whereas the incidence reached 4.7% among designated centers in the selected young nonischemic cohort. Of 126 explanted patients, 76 (60%) were subsequently delisted for sustained recovery. Heart failure relapsing had a relatively higher hazard in the early phase, with a 30-day incidence of 6% (7 of 126) but tapered following with the freedom rate of 72.5% at 4 years. ConclusionsIn the United States, LVAD explant for myocardial recovery was underutilized, leading to a very low incidence at the national level despite a realistic rate being achieved in designated centers for selected patients. With follow-up extending up to 4 years after explant, more than one-half were successfully removed and stayed off the waitlist, and approximately 70% were free from heart failure relapse events.