Durable Left Ventricular Assist Device Research Articles

Impact of concomitant aortic valve replacement in patients with mild-to-moderate aortic valve regurgitation undergoing left ventricular assist device implantation: EUROMACS analysis.

Left ventricular assist device (LVAD) therapy may lead to an aortic regurgitation, limiting left ventricular unloading and causing adverse events. Whether concomitant aortic valve replacement may improve outcomes in patients with preoperative mild-to-moderate aortic regurgitation remains unclear. A retrospective propensity score-matched analysis of adult patients with preoperative mild-to-moderate aortic regurgitation undergoing durable LVAD implantation between 01/01/2011 and 30/11/2021 was performed. Patients undergoing concomitant valve surgery other than biological aortic valve replacement were excluded, resulting in 77 with concomitant biological aortic valve replacement and 385 without. Following 1:1 propensity score matching, two groups of 55 patients with and without biological aortic valve replacement were obtained, (mean age 59 ± 11 years, 92% male, 59.1% HeartWare). Aortic regurgitation was mild in 72.7% and 76.4% and moderate in 27.3% and 23.6% in non-replacement and replacement cohorts respectively. The 30-day survival was 89.1% vs. 85.5% (p = 0.59), 1-year survival 69.1% vs. 56.4% (p = 0.19), and 2-year survival 61.8% vs. 47.3% (p = 0.10) in the non-replacement and replacement groups, respectively. After a mean follow-up of 1.2 years, non-replacement patients had a higher incidence of pump thrombosis (11 [20%] vs. 3 [5.5%], p = 0.022) and fewer major bleedings (2 [3.6%] vs. 11 [20%], p = 0.008). Compared with those treated conservatively, patients with mild-to-moderate aortic regurgitation undergoing concomitant aortic valve replacement during LVAD implantation have a similar survival up to 2 years on support. Patients with concomitant valve replacement had a higher risk of bleeding complications but fewer pump thromboses.

Intraoperative Epoprostenol in Type II Heparin-Induced Thrombocytopenia During Left-Ventricular Assist Device Implantation: A Case Series and Review of Literature.

Type II heparin-induced thrombocytopenia and thrombosis (type II HITT) is a rare but serious complication in patients receiving heparin for anticoagulation. In type II HITT, an immune-mediated reaction against platelet factor four-heparin complexes results in thrombocytopenia and an elevated risk of thrombosis. This poses significant challenges for patients with advanced heart failure requiring urgent left-ventricular assist device (LVAD) implantation. The use of direct thrombin inhibitors, the typical alternative to heparin, is associated with increased bleeding risk and lacks a reversal agent, limiting their use in cardiac surgery. We present two cases of intraoperative epoprostenol to facilitate implantation of a durable LVAD in type II HITT, of which one case underwent preoperative plasmapheresis and intravenous immunoglobulin (IVIG) therapy. Epoprostenol, a prostacyclin analog, was used intraoperatively during LVAD implantation to inhibit platelet activation and allowed for the safe administration of heparin during cardiopulmonary bypass. Both patients underwent successful LVAD implantation without thrombotic or major bleeding complications. These cases highlight the potential of using intraoperative epoprostenol in conjunction with preoperative plasma exchange (PLEX) and IVIG to mitigate the risks associated with heparin use in patients with type II HITT, offering an alternative approach for this high-risk group requiring urgent cardiac surgery.

Pump Exchange for Major Device Related Infection in Patients Receiving a Durable Left Ventricular Assist Device

BackgroundDevice-related infection (DRI) remains a cause of morbidity and mortality following durable left ventricular assist device (dLVAD) implantation. We evaluated outcomes following pump exchange (PE) for DRI following dLVAD implantation. MethodsForty-nine patients underwent PE between 1/2007 and 12/2022 for major DRI. Outcomes included survival, incidence of subsequent DRI, and proportion of patients achieving success (freedom from DRI at 1-year following PE). ResultsMedian age was 49 years. Median time from primary implant to DRI diagnosis and from diagnosis to PE was 26 and 4.1 months, respectively. Median time to DRI recurrence was 5.8 months with 76% of patients achieving success. Success was obtained in 23/24 (96%) of patients whose time to PE from DRI diagnosis was ≤ 4 months and 14/25 (56%) if time > 4 months. ConclusionMost patients achieve success following PE for DRI. The risk of subsequent DRI and mortality remains high. Early (≤ 4 months) PE following DRI diagnosis increases the likelihood of success, while reducing the rate of subsequent DRI.

Abstract 4127071: Pulmonary Artery Catheter Utilization in Cardiogenic Shock: Clinical Characteristics and Outcomes

Background: The pulmonary artery catheter (PAC) is used for hemodynamic monitoring, but its impact on patient outcomes, especially in cardiogenic shock (CS), is controversial. Several studies have shown no significant benefits and noted complications, leading to a decline in PAC use. However, PAC use appears to have increased recently in guiding management decisions in CS. Our study aims to assess the clinical characteristics and outcomes of CS patients receiving PACs versus not. Methods: We included patients with CS admitted to a tertiary academic medical center between May 2015 and December 2023. Variables were compared using Kruskal-Wallis, chi-squared, and Fisher's exact tests. Hemodynamic parameters were collected from either right heart catheterization or from a PAC. Endpoints included native heart survival to discharge, durable left ventricular assist device (LVAD) implantation, heart transplant (HTx), and 30-day and 1-year survival from discharge. Results: The study group consisted of 742 patients with CS. Of these, 385 (52%) received a PAC and 357 (48%) did not. The baseline characteristics of the two groups are shown in Table 1A . PAC patients had more severe shock, worse hemodynamics, and higher rates of temporary mechanical circulatory support (MCS) use. Hemodynamic measurements at shock onset differed, with PAC patients having higher right atrial pressures and lower cardiac index by Fick. Clinical outcomes and MCS related complications are shown in Table 1B. There was no significant difference in native heart survival at discharge, but HTx and durable LVAD implantation was higher in the PAC group. PAC placement was associated with longer hospital stays and more MCS related complications, including bleeding and hemolysis. The 30-day survival rate was similar between groups, and 1-year survival was marginally higher in the PAC group. Conclusion: PAC patients exhibited more severe clinical characteristics, longer hospital stays, higher rates of temporary MCS use and complications, durable LVAD implantation, and HTx. Short-term survival rates were similar, but 1-year survival was slightly better for PAC patients. Further studies are needed to provide clearer insights into PAC use in CS.

Metabolic Consequences of Advanced Chronic Heart Failure and its Modification by Implantation of a Durable Left Ventricular Assist Device.

Heart failure (HF) is a clinical syndrome characterized by the inability of the heart to provide adequate perfusion to tissues and organs, resulting in typical symptoms such as fatigue, dyspnea, dyspepsia, or swelling due to decreased cardiac output. With its increasing prevalence, heart failure has become one of the leading causes of morbidity and mortality worldwide, imposing a significant burden on the population by reducing long-term life expectancy and raising hospital costs. Indeed, over 20 million people worldwide suffer from heart failure, with a 5-year mortality rate of 60-70%. As heart failure progresses, various structural and metabolic changes occur within the myocardium and organ systems. In the past two decades, therapeutic options for heart failure patients have significantly expanded. In addition to novel pharmacological treatment, advanced surgical methods such as heart transplantation (HTx) and the implantation of durable left ventricular assist devices (LVADs) are available for patients with end-stage heart failure. This review discusses the pathophysiological aspects and metabolic consequences of heart failure and metabolic changes, as well as the benefits and challenges of implanting a left ventricular assist device. Furthermore, future targets for heart failure diagnostics and therapy will be highlighted.

Long-term outcomes of cardiogenic shock survivors: a contemporary retrospective analysis from a tertiary center

Abstract Background Cardiogenic shock (CS) is a complex syndrome that still portends a dismal short-term prognosis. However, in patients that survive the initial admission and are later discharged, the long-term prognosis remains ill-characterized. Aim We aimed to describe the long-term morbidity and mortality outcomes of patients surviving the index admission for CS. Methods Retrospective analysis of all consecutive patients admitted to a cardiac intensive care unit (CICU) between December 2016 and December 2022 with a diagnosis of CS. All etiologies were included and further categorized as: acute myocardial infarction (AMI-CS), acute-on-chronic heart failure (HF-CS) and secondary causes [(S-CS): myocarditis, arrhythmic storm, acute pulmonary embolism, among others]. Our primary endpoint was defined as all-cause death, conditional to being discharged alive. Secondary endpoints comprised heart transplant, durable left ventricular assist device (LVAD) implantation, implantable cardioverter-defibrillator (ICD) insertion and hospital readmission during follow-up. Results A total of 208 patients were included [median age 68 years (IQR 57-80), 66% males, mean Charlson comorbidity index 4±3], of whom 52% (n=108) had AMI-CS, 27% (n=56) HF-CS and 21% (n=44) S-CS. During the index admission, mean SAPS II score was 49±18 and most patients were in SCAI-C (66%, n=137) stage. Organ support in the form of invasive mechanical ventilation, renal replacement therapy or temporary mechanical circulatory assist devices was necessary in 62% (n=129), 27% (n=56) and 26% (n=55) of patients, respectively. 53% of patients (n=110) survived the index admission [median CICU length of stay 8 (IQR 3-15) days; median hospital length of stay 13 (IQR 4-25) days]. At discharge, mean left ventricular ejection fraction was 38±16% and 28% (n=26) of patients underwent ICD implantation. Median follow-up after discharge was 679 (IQR 373-1056) days, with 4 (4%) patients lost to follow-up. Overall mortality was 22% (n=24) and was numerically higher for AMI-CS when compared to HF-CS and S-CS (9% vs 7% vs 6% respectively, p=0.640). Secondary endpoint analysis showed that 10% (n=11) had a heart transplant, 2% (n=2) received a durable LVAD, 9% (n=10) received an ICD and 26% (n=28) were re-hospitalized during that period. Conclusions Although the long-term mortality of patients discharged alive after the index admission for CS is not overwhelming, one in every four will be readmitted and a small proportion will be eligible for advanced heart failure therapies. Healthcare strategies to improve the morbidity and mortality of many CS survivors should be devised.

Impact of HF etiology on the sustainability of favorable response after LVAD weaning: A VAD Wean Registry analysis

Abstract Background A subset of heart failure (HF) patients can experience significant improvement of their cardiac structure and function while on left ventricular assist device (LVAD) support. Purpose We sought to investigate the impact of HF etiology on the durability of cardiac improvement and favorable outcomes after LVAD weaning. Methods We studied 324 HF patients enrolled in the international multicenter VAD Wean Registry who received a durable continuous-flow LVAD and underwent device support weaning (Figure 1). Indications for VAD weaning included: structural/functional cardiac improvement meeting institutional criteria for "myocardial recovery" (responders) or LVAD-related complications accompanied by variable degrees of cardiac improvement (partial responders). Patients were divided into seven categories based on HF etiology: ischemic cardiomyopathy (CM) (n=30), post-myocarditis CM (n=65), peripartum CM (n=53), valvular CM (n=12), chemotherapy-induced CM (n=14) and idiopathic CM (n=150). The primary outcome was 2-year survival free of transplant or LVAD re-implantation. The secondary outcome was the LVEF, measured by echocardiography at 3, 6, 12 and 24 months post-LVAD weaning. Results Patients with idiopathic, peripartum and post-myocarditis CM had higher rate of 2-year survival free of transplant or LVAD re-implantation compared to patients with chemotherapy-induced CM (Figure 2-Panel A) (p-values: 0.009, 0.004, 0.001, respectively). Patients with post-myocarditis CM were also more likely to achieve the primary outcome compared to those with ischemic CM (ICM) (p-value, 0.009). The LVEF changes over time are depicted in the Figure 2-Panel B. Conclusions In this multicenter analysis the etiology of HF appears to impact the durability of favorable response after LVAD weaning. The degree of reverse remodeling achieved before VAD weaning and its impact on the durability of response in different HF etiologies warrants further investigation in studies with larger patient population and power.

Outcomes after noncardiac surgery in patients with left ventricular assist devices: a systematic review.

The number of patients living with left ventricular assist devices (LVADs) has gradually increased in the past decade. Non-cardiac surgery (NCS) in patients with LVAD poses a unique situation with its inherent challenges. We conducted a comprehensive review to investigate the perioperative complications and mortality associated with emergent or elective NCS in patients with LVAD. A comprehensive literature search for any papers referring to continuous LVAD patients with NCS. All publications with at least five durable LVAD patients who had NCS were eligible for inclusion. Twenty articles matching our criteria were found and included in our study. This systematic review included 6,476 LVAD patients who underwent 6,824 NCS. There were 5-3,216 LVAD patients with NCS in each study. The median age was between 39 and 65 years, and most of the patients (78.8%) were male. Thirty-day postoperative mortality ranged from 0% to 60%. Eight studies reported no death within the 30 days of the operation. Common complications include gastrointestinal (GI) bleeding, intracranial bleeding, infection, acute kidney injury (AKI), urinary tract infection (UTI), stroke, sepsis, pneumonia, and VAD exchange. Emergent abdominal surgery had the highest (up to 60%) mortality rate, and vascular and neurological operations had the highest complication rates. Due to the diverse range of patients in each publication and the combination of outcomes presented in various publications, a meta-analysis was not conducted. In LVAD patients, noncardiac surgery may be performed effectively and safely. LVAD patients who undergo non-cardiac surgery may require more transfusions due to their complex coagulopathies. However, perioperative management of LVAD patients undergoing emergent NCS should be optimized to reduce mortality. https://osf.io/fetsb/.

Application of donor predicted heart mass in heart transplant recipients with left ventricular assist device

IntroductionAn association between predicted heart mass (PHM) and post heart transplantation outcomes has been well established; however, there is limited data on the effect of donor PHM on recipients bridged with a durable left ventricular assist device (LVAD). This retrospective observational study seeks to challenge the theoretical benefit of oversizing donor hearts for recipients bridged with LVADs. MethodsAnalysis of the United Network for Organ Sharing (UNOS) database revealed 10,806 adult patients with one of three durable LVADs (HeartMate 2, HeartMate 3 [HM3], HeartWare [HVAD]) between January 1, 2015 and December 31, 2021. Baseline characteristics were compared between seven equally sized groups based on donor-to-recipient PHM. Univariable and multivariable Cox regression analyses were constructed to evaluate the effect of PHM size-matching on the primary outcome of 1-year post-transplant survival. Further analyses were performed specifically on HM3 patients and with PHM as a continuous variable. ResultsMultivariable analysis revealed that severely undersized donor hearts (PHM ratio < 0.86) resulted in worse outcomes with respect to 1-year mortality (HR 1.30; CI 1.03-1.64, p=0.03). There was no significant benefit to oversizing donor hearts. Similar results were found in patients bridged to transplant with HM3. ConclusionSimilar to prior studies on heart transplant recipients, recipients bridged with durable LVAD had worse outcomes when using severely undersized donor hearts. Oversized donor hearts did not significantly improve 1-year mortality, compared to size-matched references. These results were consistent in a subgroup analysis of patients bridged only with HM3 LVADs.

Galectin-3 as a Prognostic Biomarker of Left Ventricular Assist Device Implantation Outcomes.

We assessed the prognostic potential of Galectin-3 in a sample of 159 heart failure patients who received a left ventricular assist device (LVAD) implant from 2012 to 2020. Clinical outcomes included hemodynamic data, right heart failure (RHF), hemocompatibility-related adverse events (HRAEs), and mortality. Galectin-3 was compounded into Michigan-RVF and EUROMACS-RHF risk scores and compared to the noncompounded risk scores. Right heart failure was significantly correlated with Galectin (p = 0.004) on a continuous spectrum. Inotrope duration was significantly correlated to Galectin-3 (interquartile range [IQR]: 7.58-8.65, p < 0.001) along with INTERMACS score (IQR: 2.14-1.90, p < 0.001). Intensive care unit length of stay (median 8 days, p = 0.02), blood urea nitrogen (p < 0.001), creatinine (p < 0.001), and pulmonary artery pulsatility index (p = 0.05) were also significantly correlated with Galectin-3. In our c-statistic analysis, the predictive value for RHF improved when Galectin-3 was included for both the Michigan-RVF (0.80-0.86) and EUROMACS-RHF (0.77-0.82) risk scores. When elevated over a binary cutoff of 18.2 ng/ml, Galectin-3 significantly correlated with HRAEs (p = 0.014) and mortality (p = 0.031). Galectin-3 shows great promise as a predictive biomarker in patients implanted with durable LVADs. In addition to significant correlation with key clinical outcomes, Galectin-3 enhanced the Michigan-RVF and EUROMACS-RHF risk scores in predicting progression to RHF.

Mortality in Recipients of Durable Left Ventricular Assist Devices Undergoing Ventricular Tachycardia Ablation

BackgroundLeft ventricular assist device (LVAD) recipients have a higher incidence of ventricular tachycardia (VT). However, the role of VT ablation in this population is not well-established. ObjectivesThis single-center retrospective cohort study sought to examine the impact of post-LVAD implant VT ablation on survival. MethodsThis retrospective study examined a cohort of patients that underwent LVAD implantation at Baylor St. Luke’s Medical Center and Texas Heart Institute between January 2011 and January 2021. All-cause estimated mortality was compared across LVAD recipients based on the incidence of VT, timing of VT onset, and the occurrence and timing of VT ablation utilizing Kaplan-Meier survival analysis and Cox proportional hazards models. ResultsPost-implant VT occurred in 53% of 575 LVAD recipients. Higher mortality was seen among patients with post-implant VT within a year of implantation (HR: 1.62 [95% CI: 1.15-2.27]). Among this cohort, patients who were treated with a catheter ablation had superior survival compared with patients treated with medical therapy alone for the 45 months following VT onset (HR: 0.48 [95% CI: 0.26-0.89]). Moreover, performance of an ablation in this population aligned mortality rates with those who did not experience post-implant VT (HR: 1.18 [95% CI: 0.71-1.98]). ConclusionsVT occurrence within 1 year of LVAD implantation was associated with worse survival. However, performance of VT ablation in this population was correlated with improved survival compared with medical management alone. Among patients with refractory VT, catheter ablation aligned survival with other LVAD participants without post-implant VT. Catheter ablation of VT is associated with improved survival in LVAD recipients, but further prospective randomized studies are needed to compare VT ablation to medical management in LVAD recipients.

Propensity matched post-transplant survival in durable CF-axial pump BTT patients with and without diabetes: A UNOS database analysis.

Diabetes and post-transplant survival have been linked. However, the impact on post-transplant survival of patients supported on Continuous Flow (CF) axial left ventricular assist devices (LVAD) as a bridge to transplant (BTT) with diabetes has not been widely studied. This study attempts to assess the impact of diabetes type II (DM type II) as a comorbidity influencing survival patterns in the post-cardiac transplant population supported on LVADs and to test if the presence of a pre- transplant durable LVAD acts as an independent risk factor in long-term post-transplant survival. The UNOS database population from 2004 to 2015 was used to construct the cohorts. A total of 21,032 were transplanted during this period. The transplant data were further queried to extract CF-axial flow pumps BTT (HMII-BTT) patients and patients who did not have VAD support before the transplant. A total of 4224 transplant recipients had HMII at the time of transplant, and 13,131 did not have VAD support. Propensity analysis was performed, and 4107 recipients of similar patient characteristics to those in the BTT group were selected for comparison. The patients with a VAD had significantly reduced survival at 2 years post-transplant (p = 0.00514) but this trend did not persist at 5 years (p = 0.0617) and 10 years post-transplant (p = 0.183). Patients with diabetes and a VAD significantly decreased survival at 2 years (p = 0.00204), 5 years (p = 0.00029), and 10 years (p = 0.00193). The presence of a durable LVAD is not an independent risk factor for long-term survival. Diabetes has a longstanding effect on the posttransplant survival of BTT patients.

The impact of the OPTN policy change on patients with a durable left ventricular assist device and chronic kidney disease: Analysis of the UNOS database.

The Organ Procurement and Transplantation Network (OPTN) implemented modifications in 2018 to the adult heart transplant allocation system to better stratify the most medically urgent transplant candidates. We evaluated the impact of these changes on patients supported by a durable left ventricular assist device (LVAD) with chronic kidney disease (CKD). To evaluate the impact of the OPTN policy change on patients supported by durable left ventricular assist devices (LVAD) with chronic kidney disease (CKD). We performed an analysis of patients from the United Network of Organ Sharing Database supported by durable LVAD listed for a heart transplant (HT) between October 17, 2016 and September 30, 2021. Patients were divided into two groups: pre- and postpolicy, depending on whether they were listed on or prior to October 17, 2018. Patients who were on dialysis prior to surgery or discharge were excluded from the analysis. Patients with simultaneous heart and kidney transplants were excluded. Patients who were listed for transplant prepolicy change but transplanted postpolicy change were excluded. This cohort was then subdivided into degrees of CKD based on estimated glomerular filtration rate (eGFR), which resulted in 678 patients (23.7%) in Stage 1 (GFR ≥89.499) (Prepolicy: 345, Postpolicy: 333), 1233 (43.1%) in Stage 2 (89.499 > GFR ≥ 59.499) (Prepolicy: 618, Postpolicy: 615), 613 (21.4%) in Stage 3a (59.499 > GFR ≥ 44.499) (Prepolicy: 291, Postpolicy: 322), 294 (10.3%) in Stage 3b (44.499 > GFR ≥ 29.499) (Prepolicy: 143, Postpolicy: 151), 36 (1.3%) in Stage 4 (29.499 > GFR ≥ 15) (Prepolicy: 21, Postpolicy: 15), and 9 (0.3%) in Stage 5 (15 > GFR) (Prepolicy: 4, Postpolicy: 5). The primary outcome was 1-year and 2-year post-HT survival. There were 2863 patients who met the study criteria (1422 prepolicy, 1441 postpolicy). Overall survival, regardless of CKD stage, was lower following the policy change (p < 0.01). There was a similar risk of primary graft failure (PGF) in the pre- and postpolicy period (1.8% vs. 1.2%, p = 0.26). 1-year overall survival was 93% (91, 94) and 89% (87, 91) in the pre- and postpolicy periods, respectively. 2-year overall survival was 89% (88, 91) and 85% (82, 87) in the pre- and postpolicy periods, respectively. For CKD Stages 1, 2, 3a, 3b, 4, and 5, 1 -year survival was 93% (91, 95), 92% (90,93), 89% (86, 91), 89% (86, 93), 80% (68, 94), and 100% (100, 100), respectively. For CKD Stages 1, 2, 3a, 3b, 4, and 5, 2-year survival was 91% (88, 93), 88% (86, 90), 84% (81, 88), 84% (80, 89), 73% (59, 90), and 100% (100, 100), respectively. Patients with CKD 1 and 2 had better survival compared to those with CKD 3 (p < 0.01) and CKD 4 and 5 (p = 0.03) in the pre- and postpolicy periods. Patients with CKD 3 did not have a survival advantage over those with CKD 4 and 5 (p = 0.25). On cox regression analysis, advancing degrees of CKD were associated with an increased risk of mortality. Patients with LVAD support had decreased overall survival after the OPTN policy change. Patients with more advanced CKD had lower survival than patients without advanced CKD, though they were not impacted by the OPTN policy change.

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.

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

To determine if the intraoperative transfusion requirements differ based on the mechanical circulatory device used as a bridge to heart transplantation. A single-center retrospective analysis of intraoperative transfusion requirements in all patients undergoing heart or heart/kidney transplantation between November 2018 and July 2021 who were bridged with a temporary (Impella 5.5) or durable left ventricular assist device (LVAD). A tertiary care hospital. Forty-three adult patients bridged to heart or heart/kidney transplantation with a temporary or durable LVAD between 2018 and 2021 INTERVENTIONS: Recording of baseline characteristics and intraoperative transfusion requirements, including packed red blood cells, fresh frozen plasma, cryoprecipitate, autologous blood salvage, and platelets. The difference in cardiopulmonary bypass times, intensive care unit length of stay, and the vasoactive inotrope score following transplantation were also recorded. The primary outcome was the volume of blood products transfused intraoperatively. Patients who underwent bridge to transplantation using the Impella 5.5 had statistically significant lower median transfusions of cryoprecipitate (155 mL versus 200 mL, p = 0.015), autologous blood salvage (675 mL versus 1,125 mL, p ≤ 0.01), and platelets (412 mL versus 675 mL, p ≤ 0.01). Additionally, there was a trend toward lower transfusion of intraoperative packed red blood cells (4.5 units versus 6.5 units, p = 0.29) and fresh frozen plasma (675 mL versus 800 mL, p = 0.11), but these were not statistically significant. The results suggest a reduction in certain intraoperative transfusion requirements in patients undergoing heart transplantation bridged with the Impella 5.5 versus durable left ventricular assist device.

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.

Prognostic Implications of Delirium After Left Ventricular Assist Device 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).