Left Ventricular Assist Device Placement Research Articles

Long-Term Outcome After Venoarterial Extracorporeal Membrane Oxygenation as Bridge to Left Ventricular Assist Device Preceding Heart Transplantation

To determine if venoarterial extracorporeal membrane oxygenation (VA ECMO) as a bridge to left ventricular assist device (LVAD) in heart transplant (HT) candidates (ie, double bridge to HT) was associated with increased morbidity and mortality when compared to LVAD bridging to HT (ie, single bridge to HT). A retrospective analysis of patients undergoing LVAD support from 2011 to 2020. A Kaplan-Meier survival curve and Cox-Mantel hazard ratios (HR) were calculated during LVAD support and after HT. Postoperative complications were collected. University Hospital Erasme. HT candidates requiring LVAD. VA ECMO bridging to LVAD (ECMO-LVAD group [n=24]) versus LVAD (LVAD group [n=64]). Eighty-eight patients underwent HeartWare LVAD (HVAD, Medtronic) placement. Survival to hospital discharge and during the entire study period were lower in the ECMO-LVAD group (66.7% v 92.2%; p=0.0027, and 37.5% v 62.5%; p=0.035, respectively). Overall HR of death was 2.46 (95% confidence interval [CI]: 1.13-5.37; p=0.005) in the ECMO-LVAD group and remained elevated throughout their time on LVAD support (HR 3.24 [95% CI: 1.15-9.14]; p=0.0036). However, in patients who underwent HT (n=50), mortality was similar between groups (HR 1.33 [95% CI: 0.33-5.31]; p=0.66). Postoperative complications were more frequent in the ECMO-LVAD group (infection=83.3% v 51.6%, p=0.007; renal replacement therapy=45.8% v 9.4%, p=0.0001; post-LVAD ECMO=25.0% v 1.6%; p=0.0003). VA ECMO as a bridge to LVAD support before HT was associated with increased morbidity and mortality during LVAD support. However, in patients who underwent HT, outcomes were similar regardless of VA ECMO bridging.

Sustained Use of the Impella 5.0 Heart Pump Enables Bridge to Clinical Decisions in 34 Patients.

We studied whether sustained hemodynamic support (>7 d) with the Impella 5.0 heart pump can be used as a bridge to clinical decisions in patients who present with cardiogenic shock, and whether such support can improve their outcomes. We retrospectively reviewed cases of patients who had Impella 5.0 support at our hospital from August 2017 through May 2019. Thirty-four patients (23 with cardiogenic shock and 11 with severely decompensated heart failure) underwent sustained support for a mean duration of 11.7 ± 9.3 days (range, ≤48 d). Of 29 patients (85.3%) who survived to next therapy, 15 were weaned from the Impella, 8 underwent durable left ventricular assist device placement, 4 were escalated to venoarterial extracorporeal membrane oxygenation support, and 2 underwent heart transplantation. The 30-day survival rate was 76.5% (26 of 34 patients). Only 2 patients had a major adverse event: one each had an ischemic stroke and flail mitral leaflet. None of the devices malfunctioned. Sustained hemodynamic support with the Impella 5.0 not only improved outcomes in patients who presented with cardiogenic shock, but also provided time for multidisciplinary evaluation of potential cardiac recovery, or the need for durable left ventricular assist device implantation or heart transplantation. Our study shows the value of using the Impella 5.0 as a bridge to clinical decisions.

Anticoagulation Therapy Considerations in Left Ventricular Assist Devices in the Setting of Factor VII Deficiency

Background: Factor VII (FVII) deficiency is a rare bleeding disorder that affects approximately 1 out of every 500,000 people. As Warfarin inhibits the synthesis of vitamin K dependent clotting factors, it is generally contraindicated in patients with bleeding tendencies or blood dyscrasias; therefore, the literature regarding the use of warfarin in FVII deficiency is very limited. We report a successful re-challenge of warfarin therapy in a patient with FVII deficiency who needed left ventricular assist device (LVAD).Clinical case: Hematology was consulted to aid in the anti-coagulant management of a 57-year old female with coronary artery disease, ischemic cardiomyopathy (ejection fraction 15%), end stage heart failure (stage D) on home milrinone, elevated baseline prothrombin time (PT), and INR who was admitted for placement of LVAD, as a bridge to transplant. Of note, she had spontaneous oral bleeding when warfarin was given 7 years ago, after myocardial infarction after which warfarin was discontinued. She has been on aspirin 81 mg and clopidogrel 75 mg once daily. Moreover, 6 months ago, she had rectal bleeding after colonic polypectomies and needed 2 units of packed red blood cell transfusion. She always had heavy menstrual cycles and now she is post-menopausal. Family history was negative for any bleeding disorder. Social history was positive for 30 pack years smoking, which she stopped 5 years ago. Vital signs were significant for low systolic blood pressures in 90s-100s mm Hg on milrinone and heart rate in low 60s and saturating 96% on 4 liter of oxygen. Physical exam was remarkable for jugular venous distention, systolic murmur, bibasilar crackles, and grade 2 pitting edema. Laboratory tests were significant for hemoglobin (Hgb) 8.7g/dL (12-15.5 g/dl), hematocrit 28.2 (normal: 38-46%), platelet count 204 (150-450 x 103/microliter), PT 15.3 to 18.8 (normal: 11-13.5 seconds), INR between 1.4 to 1.7, PTT 21.1 sec. Liver function was normal except for mild decrease in albumin levels 3.3 g/dL (normal: 3.5-5.5 g/dl), vitamin K level 1 (0.1-2.2 ng/dl). Mixing study (1:1) has corrected the PT to 13.1 sec (ruling out the presence of inhibitory antibodies). Meanwhile, FVII assay was back with lower values– 35% (65-180%). A repeat testing also revealed a similar value (37%).As the acquired causes of FVII deficiency were ruled out (negative anti-phospholipid antibodies, appropriate reticulocyte index in the setting of anemia, no malignancy, no history of stem cell transplant) mild FVII deficiency, likely congenital, was diagnosed. Of note, sequential analysis genetic testing for F7 gene was positive for missense mutation 11128delC in exon 8. Despite lack of data of warfarin use in the setting of FVII deficiency, and LVAD, she consented to LVAD after fully understanding of risk of death from bleeding. HeartMate II LVAD was implanted. Intravenous heparin was started post-operatively with goal anti-Xa initially at 0.2 to 0.3 IU/ml that was safely titrated between 0.3 to 0.7 IU/mL with careful monitoring of bleeding. Warfarin at 2mg/day was started. Factors II, VII and X, PT and INR were closely monitored with slow titration of warfarin. The INR between 3.0 to 3.6 correlated with Factor II level of 20-40%, FVII level of 15% and Factor X level of 15-25%. Aspirin 81mg once daily was added eventually. Around 10 months after LVAD, she presented with melena, anemia (Hgb 4.8 g/dL) for which she received 3 units of packed red blood cells. Detailed evaluation showed angioectasias of the stomach and jejunum, which were cauterized. Warfarin was safely re-initiated 1 month after with goal INR lowered between 2.5 to 3.0. No more bleeding episodes occurred to date.Discussion and conclusion: Both bleeding and thrombosis occur at very high rates in the patients on LVAD, present difficult management issues, and can be life threatening. This was more challenging in the setting of FVII deficiency. We used the goals of factors II, factor VII and X levels between 20-40%, 10-15% and 15-25%, respectively, for the therapeutic window with warfarin use. For our patient, these levels correlated with INR 3-3.6. With recent GI bleeding, goal INR was lowered between 2.5-3.0 with no further bleeding episode on 6 month follow up. Our case describes a successful re-challenge of warfarin therapy in a patient with FVII deficiency. However, we must recognize the varying degrees of FVII and the corresponding bleeding risk among patients with FVII deficiency. DisclosuresNo relevant conflicts of interest to declare.

Combination Biomarkers for Risk Stratification in Patients With Chronic Heart Failure Biomarkers Prognostication in HF

Current guidelines recommend measuring natriuretic peptide biomarkers to establish prognosis in patients with chronic heart failure with reduced ejection fraction (HFrEF). We assessed whether a combination biomarkers approach improve prognostication in patients with stable HFrEF. An observational cohort study recruited 202 patients with stable HFrEF at a single center, tertiary care hospital undergoing elective cardiac resynchronization therapy device placement from 2013 to 2015. Twenty-four biomarkers were analyzed individually and in combination using Cox proportion hazard regression model for major adverse cardiac events (ie, death, cardiac transplant, left ventricular assist device placement), and major adverse cardiac events plus HF hospitalizations. The single best biomarker for predicting major adverse cardiac events is peripheral mid-regional pro-adrenomedullin (C statistic = 0.771 ± 0.045) compared to current guideline recommended N-terminal pro b-type natriuretic peptide (C=0.668 ± 0.046). The best combined biomarkers for predicting major adverse cardiac events are blood urea nitrogen, coronary sinus C-reactive protein, peripheral mid-regional pro-atrial natriuretic peptide and peripheral soluble IL-1 receptor-like 1 (C = 0.767 ± 0.036). In this observational cohort, the combined biomarkers (blood urea nitrogen, C-reactive protein, mid-regional pro-atrial natriuretic peptide and soluble IL-1 receptor-like 1) or the single biomarker (mid-regional pro-adrenomedullin) was superior to N-terminal pro B-type natriuretic peptide, the current guideline recommended biomarker in predicting cardiovascular outcomes in patients with HFrEF. Larger studies are needed to validate these findings and examine whether single or combined biomarkers improve HFrEF prognostication.

Left Ventricular Assist Devices in Patients With Active Malignancies

BackgroundThere are limited data to guide oncology and cardiology decision-making in patients with a left ventricular assist device (LVAD) and concurrent active malignancy. ObjectivesThe goal of this study was to describe cancer treatment approaches, complications, and survival among patients with active cancer on LVAD support in 2 tertiary heart failure and oncology programs. MethodsIn this retrospective cohort study, LVAD databases were reviewed to identify patients with a cancer diagnosis at the time of or after LVAD implantation. We created a 3:1 matched cohort based on age, sex, etiology of cardiomyopathy, LVAD implant strategy, and INTERMACS profile stratified by site. Kaplan-Meier analysis and Cox proportional hazards models were used to compare survival between patients with cancer and non-cancer comparators. ResultsAmong 1,123 patients who underwent LVAD implantation between 2005 and 2019, 22 patients with LVADs with active cancer and 66 matched non-cancer comparators were identified. Median age was 62 years (range 41 to 73 years); 50% of patients with cancer were African-American, and 27% were women. Prostate cancer, followed by renal cell cancer and hematologic malignancies were the most common diagnoses. There was no significant difference in unadjusted Kaplan-Meier median survival estimates from the time of LVAD placement between patients with cancer (3.53 years; 95% confidence interval [CI]: 1.41 to 5.33) and non-cancer comparators (3.03 years; 95% CI: 1.83 to 5.26; log-rank P = 0.99). In Cox proportional hazard models, cancer diagnosis as a time-varying variable was associated with a statistically significant increase in death (hazard ratio: 2.05; 95% CI: 1.03 to 4.12; P = 0.04). Patients with cancer had less gastrointestinal bleeding compared with matched non-cancer comparators (P = 0.016). Other complications were not significantly different. ConclusionsOur study provides initial feasibility and safety data and set a framework for multidisciplinary team management of patients with cancer and LVADs.

Optimal Hemodynamics and Risk of Severe Outcomes Post-Left Ventricular Assist Device Implantation.

Data on pre-implant hemodynamic optimization before continuous flow left ventricular assist device placement (CF-LVAD) with respect to patient-centered outcomes remain limited. Consecutive patients undergoing CF-LVAD implant between 2007 and 2017 were identified. Hemodynamic variables, trends, and laboratory studies were evaluated pre-LVAD implant in a logistic regression model to identify predictors of the primary composite endpoint: the need for right ventricular assist device therapy, the requirement for hemodialysis at 90 days, and 30-day mortality. Multivariate modeling identified three variables significantly associated with the primary endpoint: right ventricular stroke work index (RVSWI), right atrial pressure (RAP), and blood urea nitrogen (BUN); all immediately pre-LVAD, p < 0.01. Optimal dichotomization points were 500 mmHg*ml*m-2, 12 mmHg, and 40 mg/dL. The three-component model identified an AUC of 0.77 (p < 0.0001) for the composite endpoint. Optimization of 2/3 parameters, 1/3, and 0/3 was associated with odds ratios of 3.5 (95% CI, 1.1-11.7), 7.2 (95% CI, 2.1-24.2), and 20.6 (95% CI, 5.3-80.6), respectively, relative to those patients who were fully optimized (3/3 parameters). The number of optimized parameters was also associated with 1-year overall survival (p = 0.02). Low RVSWI, high RAP, and high BUN were independently associated with adverse outcomes after the CF-LVAD implant, demonstrating a stepwise association with severe postimplant adverse events.

Hemodynamic Predictors of Renal Function After Pediatric Left Ventricular Assist Device Implantation.

Although renal function often improves after pediatric left ventricular assist device (LVAD) implantation, recovery is inconsistent. We aimed to identify hemodynamic parameters associated with improved renal function after pediatric LVAD placement. A single-center retrospective cohort study was conducted in patients less than 21 years who underwent LVAD placement between June 2004 and December 2015. The relationship between hemodynamic parameters and estimated glomerular filtration rate (eGFR) was assessed using univariate and multivariate modeling. Among 54 patients, higher preoperative central venous pressure (CVP) was associated with eGFR improvement after implantation (p = 0.012). However, 48 hours postimplantation, an increase in CVP from baseline was associated with eGFR decline over time (p = 0.01). In subgroup analysis, these associations were significant only for those with normal pre-ventricular assist device renal function (p = 0.026). In patients with preexisting renal dysfunction, higher absolute CVP values 48 and 72 hours after implantation predicted better renal outcome (p = 0.005). Our results illustrate a complex relationship between ventricular function, volume status, and renal function. Additionally, they highlight the challenge of using CVP to guide management of renal dysfunction in pediatric heart failure. Better methods for evaluating right heart function and volume status are needed to improve our understanding of how hemodynamics impact renal function in this population.

The Evaluation of Transported Children to Pediatric Intensive Care Unit: Indications, Problems, and Outcomes

ObjectiveCritically ill children often require transport to tertiary centers where higher levels of care can be provided. In this study, we aimed to evaluate the reasons for transport, complications that occurred during transport, and the clinical outcomes of the patients transferred to our tertiary pediatric intensive care unit (PICU). MethodsThis retrospective study was conducted in a tertiary pediatric hospital with 250 beds and 20 tertiary PICU beds. ResultsDuring the study period, 108 patients were transferred to our PICU. The mean age was 75.0 ± 70.5 months (range, 1-211 months), and 59 were female. Most patients (82.4%) were transported by land; 17.6% were transported by air ambulance. Fourteen patients were referred for liver transplantation, and 7 patients were referred because of a need for extracorporeal membrane oxygenation support and heart transplantation or left ventricular assist device placement. Two patients were transported by air while on extracorporeal membrane oxygenation. Complications occurred in 25% of patients. ConclusionVital signs were assesed, and certain critical interventions such as intravenous fluids and respiratory support were provided more frequently during air transport, possibly due to the fact that physicians were always present during air transport. Quality improvement of transport teams and multicenter and nationwide studies on PICU transport are needed.

833 Evolution of sleep disordered breathing types in heart failure

Abstract Introduction Central sleep apnea is commonly seen in patients with heart failure. Here we present a case demonstrating shifting of predominant apneic events from central to obstructive type after placement of left ventricular assist device (LVAD) in end stage heart failure patient. Report of case(s) Case Presentation: 66 year-old African American male has past medical history of chronic congestive heart failure diabetes, hypertension, paroxysmal atrial fibrillation, anemia, hypothyroidism, chronic kidney disease and sleep apnea. Prior to his LVAD placement, his left ventricular ejection fraction (EF) was &amp;lt;10%. Patient was diagnosed with central sleep apnea with AHI of 58 (with 92% of apneic events being central events), oxygen nadir of 74%. Subsequently, patient had LVAD placed for symptomatic heart failure and repeat polysomnogram repeated at six month demonstrated an improved AHI of 45.8 with predominantly obstructive and mixed apneic events, with only 12.5% being central events. Conclusion This case report highlights not only the improvement of the sleep apnea in CHF treated with LVAD but also shows the shift of apneic events from predominantly central to obstructive type post LVAD. Support (if any) 1. Henein MY, Westaby S, Poole-Wilson PA, Cowie MR, Simonds AK. Resolution of central sleep apnoea following implantation of a left ventricular assist device. Int J Cardiol. 2010 Feb 4;138(3):317–9. PMID: 18752859. 2. Köhnlein T, Welte T, Tan LB, Elliott MW. Central sleep apnoea syndrome in patients with chronic heart disease: a critical review of the current literature. Thorax. 2002 Jun;57(6):547–54. PMID: 12037232 3. Monda C, Scala O, Paolillo S, Savarese G, Cecere M, D’Amore C, Parente A, Musella F, Mosca S, Filardi PP. Apnee notturne e scompenso cardiaco: fisiopatologia, diagnosi e terapia [Sleep apnea and heart failure: pathophysiology, diagnosis and therapy]. G Ital Cardiol (Rome). 2010 Nov;11(11):815–22. Italian. PMID: 21348318.

Nutritional assessment and comparison of nutritional indices in predicting adverse outcomes in patients undergoing left ventricular assist device implantation

BackgroundPreoperative malnutrition has been correlated to postoperative complications in patients with advanced heart failure undergoing placement of a left ventricular assist device (LVAD). We sought to determine whether nutritional risk scores could identify a subset of patients with an LVAD who were at high risk of adverse events. MethodsWe conducted a retrospective cohort study of all patients undergoing LVAD placement at a single center. The prognostic nutritional index (PNI), nutritional risk index (NRI), and nutrition risk in the critically ill (NUTRIC) score were calculated retrospectively from data abstracted from chart review. The primary endpoint was a composite of mortality and other adverse events associated with LVAD implantation. We used χ2 or Fisher exact tests to compare these three indices against the primary outcome. ResultsA total of 41 patients with a mean age of 57.2 ± 13.7 y and a mean body mass index of 29.3 ± 6.3 kg/m2 underwent LVAD placement between 2011 and 2019. The composite outcome at 1 y occurred in 31 (76%) patients. Preoperatively, 3 patients were identified as at high nutritional risk by the PNI score and 39 by the NRI score but none by the NUTRIC score. Most patients received nutritional interventions. The nutritional risk scores did not differ significantly between patients who experienced the composite outcome and those who did not. ConclusionsThe NRI, NUTRIC, and PNI scores did not identify a subset of patients at high risk for the composite outcome. Further studies are needed to determine how to better assess the true nutritional risk of the LVAD population. However, until better risk stratification is available, all patients with an LVAD should be consider at high risk and given appropriate nutritional interventions.

Modified technique for left ventricular assist device insertion in the setting of apical calcification.

Modified technique for left ventricular assist device insertion in the setting of apical calcification.

Kidney Function Following Left Ventricular Assist Device Implantation: An Observational Cohort Study

Rationale & ObjectiveNearly half the patients with heart failure have chronic kidney disease. Implantation of a left ventricular assist device (LVAD) improves kidney function in some but not all patients, and lack of improvement is associated with worse outcomes. Preimplantation factors that predict change in kidney function after LVAD placement are not well described.Study DesignSingle-center observational study.Setting & ParticipantsConsecutive patients undergoing LVAD implantation.Predictors48 diverse preimplantation variables including demographic, clinical, laboratory, hemodynamic, and echocardiographic variables.OutcomesThe primary outcome was change in estimated glomerular filtration rate (eGFR) at 1 month after implantation. Secondary outcomes included eGFR changes at 3, 6, and 12 months.Analytic ApproachUnivariable and multivariable linear regression.ResultsAmong 131 patients, average age was 60 ± 13 years, 83% were men, 47% had pre-existing chronic kidney disease, and mean preimplantation eGFR was 57 ± 23 mL/min/1.73 m2. At 1-month following LVAD implantation, eGFR improved in 98 (75%) patients. Variables associated with 1-month increases in eGFR were younger age, absence of diabetes mellitus (DM), use of inotropes, lower implantation eGFR, and higher implantation serum urea nitrogen, alanine aminotransferase, bilirubin, and creatinine levels. In multivariable models, younger age (β = 7.14 mL/min/1.73 m2 per SD; 95% CI, 3.17-11.10), lower eGFR (β = 7.72 mL/min/1.73 m2 per SD; 95% CI, 3.10-12.34), and absence of DM (β = 10.36 mL/min/1.73 m2; 95% CI, 2.99-17.74) were each independently associated with 1-month improvement in eGFR. Only younger age and lower eGFR were associated with improvements in eGFR at later months.LimitationsSingle-center study. Loss to follow-up from heart transplantation and death over duration of study.ConclusionsOnly younger age, lower eGFR, and absence of DM were associated with improvement in eGFR at 1 month. Thus, prediction of eGFR change at 1 month and beyond is limited by using preimplantation variables.

Colostomy Reversal in a Patient with an LVAD: A Case Report

Introduction Patients with existing Left Ventricular Assist Device (LVAD) who undergo non-cardiac surgery have a 9% risk of surgical site infection and up to a 44% chance of peri- and post-operative bleeding. This, along with the hemodynamic compromise of advanced heart failure, often makes LVAD patients prohibitively high risk for non-emergent surgeries. We present a successful case of an LVAD implanted into a patient with prior colostomy, who then later underwent a technically difficult colostomy reversal and parastomal hernia repair, without any of the aforementioned complications. Case Report A 44-year-old male with a history of non-ischemic cardiomyopathy (LVEF 20%) subsequently suffered perforated diverticulitis which was treated with a sigmoid colon resection with end colostomy. Later that year, he required LVAD (HeartMate 3™ Abbott) placement for cardiogenic shock requiring chronic inotropic support. Prior to his LVAD placement, colostomy reversal was considered to reduce the risk of post-operative LVAD driveline infection. Ultimately, colostomy reversal was deferred due to concern that a colorectal anastomosis may leak due to poor perfusion. However, he then developed a parastomal hernia with loss of domain which hindered colostomy care. Because he was weaned off inotropes and had clinically improved after his LVAD placement, it was felt he would be hemodynamically stable to tolerate colostomy reversal and subsequent parastomal hernia repair. His anticoagulation with warfarin was held for bridging enoxaparin one week before surgery. The colostomy site fascial defect was closed primarily and a sublay of synthetic mesh was placed. The surgical dissection at the old colostomy site was done to ensure there was adequate distance between the surgical field and LVAD driveline. The presence of the LVAD driveline along the right abdominal wall limited the ability to perform a right sided component separation but it was done on the left side to gain intra-abdominal domain. He remained stable during and after the procedure. Warfarin was re-started post-operative day one. Summary This demonstrates feasibility to receive an LVAD with an existing colostomy, despite risk of infection. It also highlights that patients with an LVAD can undergo colostomy reversal and parastomal hernia repair, despite risk of poor anastomosis healing, bleeding, subcutaneous infection, and LVAD driveline infection.

False Positive Hepatitis C Virus Serologies in Pediatric Patients with Left Ventricular Assist Devices

Introduction Left ventricular assist devices (LVAD) are being used more frequently in pediatric patients with advanced heart failure as a bridge to transplant. Pediatric centers began implanting the HeartMate 3 LVAD in 2017 and it has become the LVAD of choice at many centers, including our own. Allosensitization is commonly observed after LVAD placement, resulting in higher frequencies of auto-antibodies, though the pathophysiology of this phenomenon is not well understood. Viral hepatitis screening is done prior to transplant, but there are no current guidelines on type of testing and timing with regards to LVAD placement. Case Report Three pediatric patients, aged 7-12 years old, each received an LVAD as bridge to orthoptic heart transplant (OHT) between May 2019 - September 2020. All were otherwise healthy and had negative hepatitis C (HCV) antibody tests prior to Heartmate 3 LVAD placement as part of the pre-transplant infectious work up. Repeat HCV serologic testing obtained shortly before cardiac transplant were positive in all three patients. The patients had no signs or symptoms of acute HCV infection, received infrequent blood transfusions between LVAD placement and OHT, and had no increased risk behaviors. Concurrent HCV quantitative PCR testing was done in two patients and both were negative. HCV antibody testing repeated within six weeks from LVA removal was negative in all three patients. Summary False positive HCV serology secondary to immunogenicity of LVADs has been described in adult literature. Our case series is the first, to our knowledge, to be described in pediatric patients. Adult data suggests that the false positive HCV serology can occur in 16-59% of cohorts post-LVAD. This is thought to be due to immunogenicity of the LVAD as serologies revert after the LVAD is explanted. Our experience demonstrates the importance of standardizing HCV testing in patients both pre- and post-LVAD as a bridge to OHT. Furthermore, acquisition of hepatitis C infection is rare in children and pediatric cardiac transplant providers should be aware of the possibility of false positive HCV antibody tests in this clinical scenario and the importance of confirmatory testing with quantitative PCR if concerned.

Effect of Early Post-Operative Intravenous Iron Replacement in Patients with HeartMate III

<h3>Purpose</h3> Iron deficiency is a common contributor to morbidity and mortality in patients with heart failure (HF). While guidelines suggest intravenous (IV) iron to improve functional status and quality of life (QoL) in patients with NYHA class II-III HF, left ventricular assist device (LVAD) recipients were not included in early IV iron studies. Small, recent studies show benefit of IV iron after LVAD, but iron replacement occurred months after device placement. Our study compares outcomes between patients who did and did not receive IV iron during the index admission following Thoratec HeartMate III® (HM 3) LVAD placement <h3>Methods</h3> Sixty-six adult patients with a HM 3 placed at our institution who received early post-op IV ferric gluconate (n=20) or no IV iron replacement (n=46) were compared. Patients who received other IV iron replacement within 90 days before or after LVAD placement were excluded. The co-primary outcomes were mean change in health-related quality of life (by the Minnesota Living with Heart Failure Questionnaire [MLHFQ]) and 6 minute walk distance (6MWD) from baseline to first ≥ 90 day clinic follow-up. Resolution of iron deficiency and hemoglobin levels were also assessed in the IV iron group. <h3>Results</h3> Baseline characteristics were similar between groups (Table 1). The median baseline MLHFQ was 80 and 62 and 6MWD was 500 and 218 feet in the IV iron group and no IV iron groups, respectively. There was no significant difference between the IV iron and no-IV iron groups in MLHFQ (-27 ± 38 vs -29 ± 43, p = 0.262) or 6MWD (360 ± 740 vs. 607 ± 923, p = 0.118). Patients' 6MWD increased on average by 360 ± 740 feet in the IV iron group compared to 606.5 ± 923 feet in those not receiving iron. Iron deficiency resolved in 17 (85%) patients who received IV iron. <h3>Conclusion</h3> Despite a high rate of resolution of IV iron deficiency, patients receiving IV iron during index admission following HM 3 implantation did not experience an improvement in quality of life or functional capacity when compared to those who did not receive IV iron.

Trends in Renal Function Prior to and after LVAD Placement and Association with Post LVAD Mortality

<h3>Purpose</h3> To model renal function in an advanced heart failure population both prior to and after left ventricular assist device (LVAD) and to determine the association between pre-operative renal function trends and post-LVAD mortality. <h3>Methods</h3> Patients with a first time continuous-flow LVAD implant at a single center with renal function data before and after LVAD were included in the analysis (n=410). GFR at each time point was calculated with the CKD-EPI equation. Trends before and after LVAD were computed and plotted using Locally Estimated Scatterplot Smoothing (LOESS). GFR between 200 to 100 days prior to LVAD was regressed longitudinally to calculate a slope of GFR change prior to LVAD. Both the GFR slope and nadir of GFR prior to LVAD (Figure) were assessed as predictors of post LVAD mortality using multivariable cox regression. <h3>Results</h3> When assessed as a whole, GFR declined in the entire cohort prior to LVAD, improved with medical optimization, improved further post LVAD, and then declined again to a level that was similar to initially measured values. Each unit decrease in the GFR slope was associated with an adjusted 35% increase in post LVAD mortality (HR 1.36, 95% CI 1.15-1.51, p=0.002). With respect to the GFR nadir, each 10-unit decrease was associated with an adjusted 19% increase in post-LVAD mortality (HR 1.19, 95% CI 1.07- 1.30, p = 0.003). Models were adjusted for age, bridge to transplant status, ischemic cardiomyopathy, and diabetes. <h3>Conclusion</h3> This analysis demonstrates that renal function in the advanced heart failure population prior to LVAD is complex, with declines in renal function prior to LVAD, and the nadir of GFR prior to LVAD being associated with increased post LVAD mortality. This data suggest earlier LVAD placement prior to measurable renal deterioration may be beneficial.

Racial Disparities in Advanced Heart Failure Therapies: Are Outcomes the Correct Metric?

<h3>Purpose</h3> Multiple large database studies have shown that African American (AA) patients have worse outcomes after heart transplant compared to white patients, but that outcomes are similar between these groups after left ventricular assist device placement. We sought to compare outcomes after LVAD and heart transplant between different racial groups at our institution. <h3>Methods</h3> We utilized retrospective databases from our institution that include all patients that underwent heart transplant or LVAD implantation from 2009 to 2020 (323 LVAD patients, 717 heart transplant patients). Patients were stratified by race, and those categorized as white, AA, Hispanic, or Asian were included. Differences between groups were analyzed using t-tests, chi-squared tests, Kaplan Meier analysis, and cox proportional hazards models. <h3>Results</h3> AA LVAD patients were more likely to be female, and less likely to have diabetes compared to the other groups. AA, Asian, and Hispanic LVAD patients were younger than white LVAD patients. AA heart transplant recipients were less likely to have ischemic cardiomyopathy as the etiology of heart failure. There was no significant difference by log-rank test in one-year survival between races for LVAD patients or heart transplant patients (figure 1). There was a trend towards less AA LVAD patients undergoing transplant among those eligible (81% compared to 97% of white patients, 85% of Asian patients and 90% of Hispanic patients), but this was not statistically significant (p-value 0.06). <h3>Conclusion</h3> At our institution, there is no significant difference in one-year survival after LVAD implantation or heart transplant by race, but AA patients may be less likely to receive a transplant. These data are important because they suggest we should focus resources on access to care among AA patients. Future work will involve examining the heart failure population within our health system and county to determine if AA patients are offered LVAD and heart transplant at the same rates as white patients.

Optimization Prior to Left Ventricular Assist Device Implantation is Associated with Reduced Risk of Severe Early Post-Implant Complications

<h3>Purpose</h3> Although hemodynamic status prior to continuous flow left ventricular assist device placement (CF-LVAD) is an important determinant of outcomes, data on pre-implant optimization and patient-oriented outcomes are sparse. <h3>Methods</h3> We identified consecutive patients undergoing CF-LVAD implant between 2007 and 2017 at a single institution. Hemodynamic variables at three time points and laboratory studies were evaluated pre-LVAD implant in a logistic regression model to identify predictors of the primary composite endpoint: need for right ventricular assist device (RVAD) therapy, requirement for hemodialysis at 90 days, and 30-day mortality. <h3>Results</h3> Multivariate modeling identified three variables significantly associated with the primary endpoint: right ventricular stroke work index (RVSWI), right atrial pressure (RAP), and blood urea nitrogen (BUN); all immediately pre-LVAD, <i>P</i><.01. Optimal dichotomization points (rounded) were 500 mmHg*ml*m⁻², 12 mmHg, and 40 mg/dL, respectively. The three-component model identified an AUC of 0.77 (<i>P</i><.0001) for the composite endpoint. Optimization of 2/3 parameters, 1/3, and 0/3 was associated with of odds ratios of 2.4 (95% CI 0.8-7.6), 5.5 (1.8-17.0), and 18.9 (4.9-73.1), respectively, for the primary endpoint relative to those patients who were fully optimized (3/3 parameters). Number of optimized parameters was also associated with 1-year overall survival (<i>P</i>=.02). <h3>Conclusion</h3> Low RVSWI, high RAP, and high BUN were independently associated with adverse outcomes after CF-LVAD implant, and demonstrated a stepwise association with severe post-implant adverse events. Prospective, protocol-driven hemodynamic optimization should be tested to improve outcomes after CF-LVAD implantation.

Micro RNA Expression of Heart Failure Patients and Responses to Left Ventricular Assistant Device Support

Purpose Micro RNAs are key regulators of various biological processes including the pathogenesis of heart failure (HF). In this study we compared miRNA profiles of heart failure (HF), left ventricular assist devices (LVAD) and non-failing (NF) hearts patients. Our goal was to identify epigenetic mechanisms involved in HF and responses to LVAD therapy. Methods RNAs were isolated from myocardial tissues of HF patients without mechanical support at the time of transplant (n=6) and after LVAD (n=6) placement in non-ischemic dilated cardiomyopathy patients along with NF controls (n = 6). NanoString analysis was used to compare miRNA expression among in HF, LVAD, and control patients. NanoString miRNA raw count data were preprocessed and normalized using nSolver 4.0 Analysis Software. Ingenuity Pathway Analysis (IPA) was carried out on differentially expressed micro RNA to understand the biological pathways involved. Results Our sample population was 84% male with an average age of 57 and 82% Caucasian, 16% African American and 2% Asian. Forty four miRNAs were differentially expressed in HF patients than NF control and 79 miRNAs were differentially expressed in HF patients when compared to post-LVAD HF patients. IPA analysis revealed that heart enlargement was significantly altered in HF compared to NF control with p value of 2.58E-04. Three miRNA were upregulated (mir590-5p, mir146a-5p and mir-761-5p) and three were downregulated by more than two folds (mir-1, mir-23a-3p and mir497-5). Heart enlargement was also significantly different in pre vs post with p value of 2.57E-02. Five miRNAs were involved with four upregulated (mir-590-5p, mir146a-5p, mir-761 and mir 140-3p) while only one was downregulated (mir-497-5p). Conclusion End stage heart failure is characterized by cardiac remodeling, arrhythmias, fibrosis and a decline in myocyte contractility. Our results identify a large number of miRNAs that are associated with end stage heart failure and cardiac enlargement in addition to the miRNAs associated with remodeling on LVAD therapy. Micro RNA profiles can identify molecular mechanisms of disease and serve as potential biomarkers or therapeutic targets.

Variation in CardioMEMS Pressure Measurements Due to Frequent Changes in Altitude in a Patient with HeartMate III LVAD

Introduction Implantation of a wireless pulmonary artery pressure monitoring device [CardioMEMS] has been utilized to monitor hemodynamic parameters in patients with NYHA Class III heart failure, however the impact of travel between altitudes on device calibration in patients who have received the Heart Mate III (HM3) Left Ventricular Assist Device (LVAD) is unknown. We describe a case of poorly correlating CardioMEMS readings with Swan-Ganz catheter measurements in a patient requiring frequent travel. Case Report A 53 year old man underwent placement of a CardioMEMS device 4 months prior to placement of a HM3 LVAD for stage D non-ischemic cardiomyopathy and was noted to have significant increases in the device's pulmonary arterial pressure readings. The patient was clinically stable and well compensated with stable LVAD settings and no alarms were noted. His chest X-ray showed stable position of his CardioMEMS device, clear lung fields, and a stable LVAD device position. Pulmonary artery waveform on the CardioMEMS device was normal. Repeat right heart catheterization at his home institution showed significant discrepancy between Swan-Ganz catheter measurements and his CardioMEMS readings. The difference in mean pulmonary artery pressure was roughly 15 mmHg. The device had been auto-calibrated at a different institution that was 3996 ft (1217 m) higher in altitude. The patientʼs travel between institutions continued due to active transplant evaluation and the CardioMEMS auto re-calibrated to the higher altitude setting despite recalibration twice at the home institution. The decision was made to turn off his CardioMEMS and monitor the patient clinically. Summary CardioMEMS device implantation can assist in remote monitoring of heart failure patients with LVADs. Accuracy of the device may be affected by large changes in elevation between the initial baseline calibration and subsequent measurements (2mm Hg per 305 meters elevation change) in patients without an LVAD per the device manufacturer. This case highlights the importance of considering changes in elevation of different geographic calibration locations as potential causes for error in CardioMEMS pressure readings prior to adjustment of medications. Further investigation is needed to evaluate changes in CardioMEMS pressure readings as it correlates to changes in altitude in LVAD patients.