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The aim of this study was to assess for distinct kidney function trajectories following left ventricular assist device (LVAD) placement. Cohort studies of LVAD recipients demonstrate that kidney function tends to increase early after LVAD placement, followed by decline and limited sustained improvement. Inter-individual differences in kidney function response may be obscured.We identified continuous flow LVAD implantations in US adults (2016-2017) from INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). Primary outcomes were estimated glomerular filtration rate (eGFR) trajectories pre-implantation to ∼12 months. Latent class mixed models were applied to primary and validation samples. Clinical differences among trajectory groups were investigated.Among 4,615 LVAD implantations, 5 eGFR trajectory groups were identified. The 2 largest groups (Groups 1 and 2) made up80% of the cohort, and were similar to group average trajectories previously reported, with early eGFR rise followed by decline and stabilization. Three novel trajectory groups were found: worsening followed by sustained low kidney function (Group 3, 10.1%), sustained improvement (Group 4, 3.3%), and worsening followed by variation (Group 5, 1.7%). These groups differed in baseline characteristics and outcomes. Group 4 was younger and had more cardiogenic shock and pre-implantation dialysis; Group 3 had higher rates of pre-existing chronic kidney disease, along with older age.Novel eGFR trajectories were identified in a national cohort, possibly representing distinct cardiorenal processes. Type 1 cardiorenal syndrome may have been predominant in Group 4, and parenchymal kidney disease may have been predominant in Group 3.

In the 2016 ISHLT listing criteria guidelines for heart transplantation, recipients were recommended to have a body mass index (BMI)35 kg/m². However, outcomes data for subgroups of transplant recipients with a BMI35 kg/m² are limited. We examined the outcomes of heart transplant recipients who had a BMI of 35 to 39.9 kg/m² or ≥40 kg/m² and compared their outcomes with recipients who had a BMI35 kg/mUsing data from the United Network for Organ Sharing database, we performed a retrospective cohort analysis of 23,009 adults who underwent cardiac transplantation between 2009 and 2018. Transplant recipients were stratified by BMI categories (35 kg/m², 35-39.9 kg/m², and ≥40 kg/m²). Patient survival was depicted by Kaplan-Meier curves. Cox proportional-hazards modeling was used to determine the prognostic factors associated with mortality within 90 days, 1 year, and 5 years after transplantation.Survival at 90 days, 1 year, and 5 years after transplantation was better in recipients who had a BMI35 kg/m² than in those who had a BMI of 35 to 39.9 kg/m² (P values ranged from 0.01 to0.001) or ≥40 kg/m² (P0.001). Additionally, survival at 90 days (P0.001) and 1 year (P = 0.002) was significantly better in recipients who had a BMI of 35 to 39.9 kg/m² than in those who had a BMI ≥40 kg/m². In multivariate analysis, a BMI of 35 to 39.9 was significantly associated with increased 90-day mortality (HR = 1.53; 95% CI 1.12, 2.08; P = 0.01) but not increased 1-year (HR = 1.28; 95% CI 0.99, 1.66; P = 0.06) or 5-year mortality (HR = 1.11; 95% CI 0.91, 1.36; P = 0.29).Although heart transplant recipients with class II obesity (BMI 35-39.9 kg/m²) may have suboptimal survival compared with those who have a BMI35 kg/m², these patients have better outcomes than do those with class III obesity (BMI ≥40 kg/m²). Thus, contrary to current guidelines, selected patients with class II obesity should be considered for transplantation.

Warfarin is standard anticoagulation therapy for patients with a continuous-flow left ventricular assist device (CF-LVAD). However, warfarin requires regular monitoring and dosage adjustments and fails for many patients, causing thromboembolic and bleeding events. Factor Xa inhibitors have been shown to be noninferior to warfarin in preventing strokes and are associated with less intracranial hemorrhage in patients with atrial fibrillation. We evaluated treatment safety and effectiveness in CF-LVAD patients who switched from warfarin to a factor Xa inhibitor (apixaban or rivaroxaban) after warfarin failure. This was a retrospective, single-center study of patients treated between 2008 and 2018. We assessed the occurrence of stroke, non-central nervous system (CNS) embolism, pump thrombosis, and major gastrointestinal bleeding and intracranial hemorrhage during therapy. We identified seven patients: five were male, the average body mass index was 30 kg/m2, and average age was 56 years. Preimplantation comorbidities included hypertension (all patients) and diabetes mellitus, ischemic cardiomyopathy, atrial fibrillation, and previous myocardial infarction (four patients each). Overall, patients received warfarin for 3968 days and apixaban/rivaroxaban for 1459 days. The warfarin group was within the therapeutic INR range (2.0–3.0) 30% of the time. Complication rates did not differ between warfarin and apixaban/rivaroxaban: strokes, 0.20 vs none, non-CNS embolism, 0.54 vs none; pump thrombosis, 0.27 vs none; major gastrointestinal bleeding, 0.20 vs 0.50; intracranial hemorrhage, 0.13 vs none. Factor Xa inhibitors may be viable treatment options for CF-LVAD patients for whom warfarin therapy has failed. Large prospective studies are necessary to confirm these results.

Bariatric surgery helps many morbidly obese patients lose substantial weight. However, few data exist on its long-term safety and effectiveness in patients who also have continuous-flow left ventricular assist devices and in whom heart transplantation is contemplated. We retrospectively identified patients at our institution who had undergone ventricular assist device implantation and subsequent laparoscopic sleeve gastrectomy from June 2015 through September 2017, and we evaluated their baseline demographic data, preoperative characteristics, and postoperative outcomes. Four patients (3 men), ranging in age from 32 to 44 years and in body mass index from 40 to 57, underwent sleeve gastrectomy from 858 to 1,849 days after left ventricular assist device implantation to treat nonischemic cardiomyopathy. All had multiple comorbidities. At a median follow-up duration of 42 months (range, 24–47 mo), median body mass index decreased to 31.9 (range, 28.3–44.3) at maximal weight loss, with a median percentage of excess body mass index lost of 72.5% (range, 38.7%–87.4%). After achieving target weight, one patient was listed for heart transplantation, another awaited listing, one was kept on destination therapy because of positive drug screens, and one regained weight and remained ineligible. On long-term follow-up, laparoscopic sleeve gastrectomy appears to be safe and feasible for morbidly obese patients with ventricular assist devices who must lose weight for transplantation consideration. Additional studies are warranted to evaluate this weight-loss strategy after transplantation and immunosuppression.

Implantable continuous-flow left ventricular assist devices (CF-LVADs) are used for long-term LV support in bridging patients to heart transplantation or as destination therapy. With prolonged support times, some patients will have repeat complications necessitating multiple device exchanges. To elucidate the safety and efficacy of repeat device exchange, we retrospectively reviewed data from 25 patients who underwent two or more CF-LVAD implantations between July 2005 and August 2017. Indications for exchange were thrombus/hemolysis (n = 8, 32%), electromechanical device malfunction (n = 14, 56%), and infection (n = 3, 12%). The implanted devices were the HeartMate II (n = 13, 52%), the HeartWare HVAD (n = 11, 44%), and the Jarvik 2000 (n = 1, 4%). Average hospital length of stay was 44 days (range 4-221 days), and 17 patients (68%) survived to discharge. Average duration of support after the most recent LVAD implantation was 802 days (range 1-3,229 days). Overall survival was 72% at 1 year and 60% at 2 years. Postoperative complications included respiratory failure in five patients (20%), device infection in five (20%), bleeding requiring reoperation in four (16%), neurologic dysfunction in four (16%), and acute renal failure in two (8%). Overall, our data suggest that repeat LVAD exchange is a feasible option for patients with recurrent device-related complications.

Hyponatremia is associated with adverse outcomes in heart failure and after cardiac surgery. We hypothesized that hyponatremia is associated with poorer short-term and longer term survival in patients after continuous-flow left ventricular assist device (CF-LVAD) placement.We reviewed a single-center database of patients who received a CF-LVAD during 2012-2017. Sodium (Na) values obtained within 14 days before CF-LVAD insertion were averaged; patients (n = 332) were divided into hyponatremia (mean Na135 mEq/L; n = 160; 48.2%) and normonatremia groups (mean Na 135-145 mEq/L; n = 172; 51.8%). Patients requiring preoperative dialysis or pump exchange were excluded. We compared outcomes between preoperative hyponatremia and normonatremia groups.The two groups' baseline characteristics were similar, although hyponatremia patients more often had preoperative mechanical circulatory support (44.4% vs. 31.4%, p = 0.002). Although hyponatremic and normonatremic patients did not differ in 30-day mortality (7.5% vs. 6.5%, p = 0.7), preoperative hyponatremia was associated with greater 5-year mortality (61% vs. 44%, p = 0.03). On binary logistic regression analysis, the strongest independent predictors of late mortality were hyponatremia (odds ratio [OR] 1.88, 95% CI [1.07-3.31], p = 0.02), older age (OR 1.03, 95% CI [1.01-1.05], p = 0.01), and elevated mean right atrial pressure/pulmonary capillary wedge pressure ratio (OR 4.69, 95% CI [1.76-12.47], p = 0.002).Hyponatremia was not associated with greater early mortality but was associated with poorer late survival. The optimal timing of LVAD implantation in relation to hyponatremia, and whether correcting hyponatremia perioperatively improves long-term survival, should be investigated.

Background As more left ventricular-assist devices (LVADs) are implanted, multidrug-resistant LVAD infections are becoming increasingly common, partly due to bacterial biofilm production. To aid in developing bacteriophage therapy for LVAD infections, we have identified the most common bacterial pathogens that cause LVAD driveline infections (DLIs) in our heart transplant referral center. Materials and methods We studied a retrospective cohort of patients who received LVADs from November 2003 to August 2017 to identify the common causative organisms of LVAD infection. We also studied a prospective cohort of patients diagnosed with DLIs from October 2018 to May 2019 to collect bacterial strains from DLIs for developing bacteriophages to lyse causative pathogens. LVAD infections were classified as DLI, bacteremia, and pump/device infections in the retrospective cohort. Results In the retrospective cohort of 582 patients, 186 (32.0%) developed an LVAD infection, with 372 microbial isolates identified. In the prospective cohort, 96 bacterial strains were isolated from 54 DLIs. The microorganisms causing DLIs were similar in the two cohorts; the most common isolate was Staphylococcus aureus. We identified 6 prospective S. aureus strains capable of biofilm formation. We developed 3 bacteriophages that were able to lyse 5 of 6 of the biofilm-forming S. aureus strains. Conclusions Similar pathogens caused LVAD DLIs in our retrospective and prospective cohorts, indicating our bacterial strain bank will be representative of future DLIs. Our banked bacterial strains will be useful in developing phage cocktails that can lyse ≥80% of the bacteria causing LVAD infections at our institution.

To determine whether the cause of cardiomyopathy affects outcomes in patients who undergo continuous-flow left ventricular assist device support, we compared postimplant adverse events and survival between patients with ischemic and nonischemic cardiomyopathy. The inclusion criteria for the ischemic group were a history of myocardial infarction or revascularization (coronary artery bypass grafting or percutaneous coronary intervention), ≥75% stenosis of the left main or proximal left anterior descending coronary artery, or ≥75% stenosis of ≥2 epicardial vessels. From November 2003 through March 2016, 526 patients underwent device support: 256 (48.7%) in the ischemic group and 270 (51.3%) in the nonischemic group. The ischemic group was older (60.0 vs 50.0 yr), included more men than women (84.0% vs 72.6%), and had more comorbidities. More patients in the nonischemic group were able to have their devices explanted after left ventricular recovery (5.9% vs 2.0%; P=0.02). More patients in the ischemic group had gastrointestinal bleeding (31.2% vs 22.6%; P=0.03), particularly from arteriovenous malformations (20.7% vs 11.9%; P=0.006) and ulcers (16.4% vs 9.3%; P=0.01). Kaplan-Meier analysis revealed no difference in overall survival between groups (P=0.24). Older age, previous sternotomy, higher total bilirubin level, and concomitant procedures during device implantation independently predicted death (P ≤0.03), whereas cause of heart failure did not (P=0.08). Despite the similarity in overall survival between groups, ischemic cardiomyopathy was associated with more frequent gastrointestinal bleeding. This information may help guide the care of patients with ischemic cardiomyopathy who receive continuous-flow left ventricular assist device support.

Background Despite technological advancements, pump durability and pump-related complications continue to affect and adversely impact the lives of patients with end-stage heart failure on left ventricular assist device (LVAD) support. In an attempt to avoid recurrent LVAD-related complications, there may be circumstances where it is clinically advantageous to exchange a patient's device from HeartMate II to HeartWare HVAD. However, there is a paucity of data that describes the safety and feasibility of such an approach. Objective We present the largest single-center series of HeartMate II (HMII) to HeartWare (HVAD) device exchanges. Methods A retrospective review of 11 patients who underwent HMII to HVAD exchange from 2012 to 2017 was conducted to evaluate patient characteristics, incidence of postoperative complications, and survival. Results Eleven male patients (mean age 55 ± 14.4 years) underwent HMII to HVAD device exchange. One patient expired on postoperative day 7 secondary to sepsis. One patient was lost-to-follow-up after 23 months. An additional three patients died at 5, 7, and 24 months. Mean follow-up after device exchange was 1555 ± 311 days for the remaining six patients. None of the 11 study patients underwent LVAD explant, further device exchange, or heart transplant. Conclusion Exchange of an HMII LVAD to an HVAD can be performed safely with acceptable perioperative morbidity and mortality.

There are only 2 treatments for the thousands of patients who progress to the most advanced form of heart failure despite the application of guideline-based medical therapy, use of ventricular assist devices and heart transplantation. There has been a great deal of progress in both of these therapies that have led to improved outcomes including significant improvement in survival and functional capacity. Heart transplantation offers the best short- and long-term survival for patients with end-stage heart failure, and the majority of these recipients achieve relatively limitless functional capacity for their age. However, the chronic shortage of available donors limits the number of recipients in the United States to an only 2500 patients/y or only a fraction of potential candidates. The significant improvement in outcomes now possible with durable ventricular assist devices has led to a significant increase in their use, which now exceeds the volume of heart transplants in the United States, with the greatest growth in use for those not considered to be candidates for heart transplantation, previously referred to as destination therapy. This article will review the substantial progress that has taken place for both of these life-saving treatment options, as well as the future directions.

OBJECTIVES Dialysis is considered a contraindication to continuous-flow left ventricular assist device (CF-LVAD) implantation. We evaluated clinical outcomes and survival in carefully selected, low-risk patients with renal failure who required dialysis before CF-LVAD implantation. METHODS We extracted medical record data of patients who underwent CF-LVAD placement at our centre between 1 January 2006 and 31 August 2017, with 2 clinical scenarios: those who required long-term (>14 days) dialysis and those who required short-term (≤14 days) dialysis immediately before implantation. Demographic, clinical and intraoperative characteristics and survival outcomes were assessed. RESULTS Of 621 patients who underwent CF-LVAD implantation during the study period, 31 underwent dialysis beforehand. Of these, 17 required long-term dialysis (13 haemodialysis, 4 peritoneal dialysis), and 14 underwent short-term haemodialysis. Compared with the long-term dialysis patients, the short-term dialysis patients were more likely to be Interagency Registry for Mechanically Assisted Circulatory Support profile 1–2 (92.9% vs 70.6%; P CONCLUSIONS Carefully selected patients who are stable on long-term dialysis have acceptable survival rates after CF-LVAD implantation. Patients with acute renal failure had much poorer outcomes than those with chronic end-stage renal disease.

Left ventricular assist devices (LVADs) are increasingly used as destination therapy or as a bridge to future cardiac transplant in patients with end-stage heart failure. Extracorporeal membrane oxygenation (ECMO) can be used to bridge patients in cardiogenic shock or with decompensated heart failure to durable mechanical circulatory support. We assessed outcomes in patients in critical cardiogenic shock (Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS] profile 1) who underwent implantation of a continuous-flow (CF)-LVAD, with or without preoperative ECMO bridging. For this retrospective study, we selected INTERMACS profile 1 patients who underwent CF-LVAD implantation at our institution between Sep 1, 2004 and Nov 30, 2018. Of 768 patients identified, 133 (17.3%) were INTERMACS profile 1; 26 (19.5%) received preoperative ECMO support, and 107 (80.5%) did not. Postimplantation outcomes were compared between the ECMO and no-ECMO groups. No significant differences were found in 30-day mortality (15.4 vs. 15.9%, P = 0.95) or survival at 1 year (53.8 vs. 60.9%, P = 0.51). Three patients who received ECMO before CF-LVAD implantation subsequently underwent cardiac transplant. In the ECMO group, the lactate level 1 day after ECMO initiation was lower in survivors than nonsurvivors (2.7 ± 2.2 vs. 7.4 ± 4.2 mmol/L, P = 0.02; area under the curve = 0.85, P = 0.01) after CF-LVAD implantation. Bridging with ECMO to CF-LVAD implantation in carefully selected INTERMACS profile 1 patients (those who are at the highest risk for critical cardiogenic shock and for whom palliation may be the only other option) produced acceptable postoperative outcomes. Field of research: Artificial lung/ECMO.

IMPORTANCE: With continuing improvements in medical devices and more than a decade since the 2006 United Network for Organ Sharing (UNOS) allocation policy, it is pertinent to assess survival among patients on the heart transplantation waiting list, especially given the recently approved 2018 UNOS allocation policy. OBJECTIVES: To assess survival outcomes among patients on the heart transplant waiting list during the past 3 decades and to examine the association of ventricular assist devices (VADs) and the 2006 UNOS allocation policy with survival. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cross-sectional used the UNOS database to perform an analysis of 95 323 candidates wait-listed for heart transplantation between January 1, 1987, and December 29, 2017. Candidates for all types of combined transplants were excluded (n = 2087). Patients were followed up from the time of listing to death, transplantation, or removal from the list due to clinical improvement. Competing-risk, Kaplan-Meier, and multivariable Cox proportional hazards regression analyses were used. MAIN OUTCOMES AND MEASURES: The analysis involved an unadjusted and adjusted survival analysis in which the primary outcome was death on the waiting list. Because of changing waiting list preferences and policies during the study period, the intrinsic risk of death for wait-listed candidates was assessed by individually analyzing, comparing, and adjusting for several candidate risk factors. RESULTS: In total, 95 323 candidates (72 915 men [76.5%]; mean [SD] age, 51.9 [12.0] years) were studied. In the setting of changes in listing preferences, 1-year survival on the waiting list increased from 34.1% in 1987-1990 to 67.8% in 2011-2017 (difference in proportions, 0.34%; 95% CI, 0.32%-0.36%; P

Introduction Left ventricular assist devices (LVAD) are used as a bridge to heart transplant or destination therapy for patients with the New York Heart Association (NYHA) class 3 or 4 heart failure. Acute kidney injury (AKI) or need for renal replacement therapy (RRT) post-LVAD implant can lead to poor outcomes. Identifying risk factors of AKI post-LVAD implant can help stratify potential LVAD candidates. Methods This is a retrospective study of all patients who received continuous-flow LVAD at our institution from January 2015 until August 2017. We calculated the incidence of AKI and the need for RRT post-LVAD implant, as well as the rate of renal recovery and survival rates at 30 days and 1-year post-LVAD implant. The presence of chronic kidney disease (CKD) and proteinuria was assessed, and kidney ultrasound results were reviewed on all patients, if available. CKD was present if estimated glomerular filtration rate (eGFR) was

The widespread acceptance of left ventricular assist device (LVAD) implantation in the treatment of heart failure has revolutionized the way end-stage heart failure is treated. Advances in LVAD and other continuous-flow technology combined with a better understanding of patient selection has led to unparalleled survival as well as a reduction in the adverse event profile of these pumps. As our understanding of heart failure continues to grow, there is little doubt that emerging continuous-flow technologies will continue to play an important role for patients with end-stage heart failure.

Purpose We explored if utilization of continuous flow (CF-LVADS) has increased amongst females in the age of new-generation devices, which are smaller and more durable. We also compared outcomes between female and male CF-LVAD recipients. Methods The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) was queried to identify 20,324 CF-LVAD recipients from June 2008 to December 2017, of which 4350 (21.4%) were female and 15,974 (78.6%) were male. Survival was compared after propensity matching for age ≥ 50 yr, heart failure etiology, body surface area, INTERMACS class, co-morbidities, device strategy as destination or bridge to transplant therapy, temporary mechanical circulatory support, and device type. Results In 2008, women made up 22.5% of CF-LVAD recipients but that decreased to 20.9% in 2016 (Figure 1a). After propensity matching, baseline characteristics were comparable between 2463 females and 3925 males with the exception of mean right atrial pressure / pulmonary capillary wedge pressure which was higher in women (0.50 vs 0.45, p Conclusion Women with heart failure are far less likely to receive CF-LVADs and despite propensity matching, women are more likely to present with right heart failure at time of implantation. The higher mortality risk may be due to women presenting with more advanced heart failure at time of referral for CF-LVAD.

Objective Determine the feasibility and predictors of early discharge after minimalist transcatheter aortic valve replacement (TAVR). Background Duration of hospitalization has a direct impact on overall cost of care, but the clinical impact of length of stay (LOS) in patients undergoing minimalist TAVR remains unclear. Methods We studied 268 patients who underwent minimalist TAVR. Short LOS (sLOS) was defined as post-procedural LOS ≤ 3 days and observed in 163 patients. Prolonged LOS (pLOS) was observed in 105 patients. Propensity score matching based on 39 variables yielded 54 pairs of patients in each group. We analyzed 30-day mortality, 30-day re-hospitalization and long-term survival data. Multivariate regression models were used to define predictors of sLOS. Results Thirty-day mortality was 0% versus 5.5% in the sLOS and pLOS groups, respectively (P = 0.08). Incidence of re-hospitalization was higher in pLOS (13% vs. 3.7%). sLOS was associated with lower odds ratio of minor vascular complication (OR 0.1 [95% CI: 0.01, 0.75], P = 0.05), any bleeding (OR 0.35 [95% CI: 0.14, 0.87], P = 0.02), blood transfusion (OR 0.27 [95% CI: 0.08, 0.81], P = 0.02), and new pacemaker implantation (OR 0.23 [95% CI: 0.1, 0.53], P

Anticoagulation with unfractionated heparin is vital to reduce the risk of thromboembolic events during cardiopulmonary bypass and left ventricular assist device placement. However patients with heparin-induced thrombocytopenia are at risk of developing immune-mediated thrombotic events. We describe 2 patients with heparin-induced thrombocytopenia confirmed via serotonin release assay who were successfully treated with plasmapheresis exchange before left ventricular assist device placement.

Purpose Hyponatremia is a recognized risk factor for adverse outcomes in heart failure and after cardiac surgery. We hypothesized that hyponatremia would be associated with poorer short-term and longer-term survival in patients after continuous-flow left ventricular assist device (CF-LVAD) placement. Methods Patients who received a CF-LVAD between January 2012 and December 2017 were identified in a single-center database. Sodium values within 14 days of LVAD insertion were averaged; hyponatremia was defined as Na Results Out of 322 patients, 49.7% (n=160) were found to have hyponatremia prior to LVAD insertion. There were no significant differences in comorbidities between groups. Pre-operative hyponatremia was associated with increased length of post-operative stay (38 vs 30 days, p=0.02). Though there was no difference in short-term (90-day) mortality, hyponatremia was associated with increased long-term, five-year mortality (61% vs 44%, p=0.03) (Figure 1). On binary logistic regression analysis, hyponatremia (OR 1.88 95% CI [1.073-3.315], p=0.03), increased age (OR 1.03 95% CI [1.007-1.053], p=0.01), elevated neutrophil-lymphocyte ratio (OR 1.064 95% CI [1.004-1.128], p=0.037), decreased albumin (OR 0.94 95% CI [0.887-0.992], p=0.03), and elevated mean right atrial pressure/pulmonary capillary wedge pressure ratio (OR 4.69 95% CI [1.762-12.473], p=0.002) were independent risk factors of mortality. Conclusion Pre-operative hyponatremia is associated with increased mortality after LVAD implantation and can be used as a marker or added to existing risk scores to further risk stratify patients. Whether hyponatremia correction improves long-term survival should be investigated.

In this study, we sought to determine the accuracy of several critical care risk scores for predicting survival of Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile 1 patients after continuous-flow left ventricular assist device (CF-LVAD) placement. We retrospectively analyzed the records of 605 patients who underwent CF-LVAD implantation between 2003 and 2016. We calculated the preoperative HeartMate II Risk Score (HMRS) and preoperative Right Ventricular Failure Risk Score (RVFRS) and the following risk scores for postoperative days 1-5: HMRS, RVFRS, Model for End-stage Liver Disease (MELD), MELD-eXcluding International Normalized Ratio, Post Cardiac Surgery (POCAS) risk score, Sequential Organ Failure Assessment (SOFA) risk score, and Acute Physiology and Chronic Health Evaluation III. The preoperative scores and the postoperative day 1, 5-day mean, and 5-day maximum scores were entered into a receiver operating characteristic curve analysis to examine accuracy for predicting 30-day, 90-day, and 1-year survival. The mean POCAS score was the best predictor of 30-day and 90-day survival (area under the curve [AUC] = 0.869 and 0.816). The postoperative mean RVFRS was the best predictor of 1-year survival (AUC = 0.7908). The postoperative maximum and mean RVFRS and HMRS were more accurate than the preoperative scores. Both of these risk score measurements of acuity in the postoperative intensive care unit setting help predict early mortality after LVAD implantation.

Introduction: Postoperative atrial fibrillation (POAF) is one of the most common complications after cardiac surgery and is especially hazardous in elderly patients and those with left ventricular dysfunction. Therefore, we sought to find the associated risk factors and predictors for the development of POAF in patients undergoing left ventricular assist device (LVAD) implantation. Materials and methods: We retrospectively reviewed 109 patients with no prior history of atrial fibrillation undergoing continuous flow LVAD implantation at a single center institution from 2013-2017. Results: POAF lasting 24 hours or greater occurred in 29 of 109 patients (26.6%). Early 30-day mortality was higher in POAF patients compared to non-POAF (6.9% vs 0%, p=0.02) (Figure). Patients with POAF had higher rates of pump exchange although this did not reach statistical significance (17.2% vs 6.3%, p=0.08). However, POAF was not associated with stroke (10.3% vs 23.8%, p=0.24) or long-term mortality (27.6% vs 31.3%, p=0.8). The only independent risk factor for POAF was elevated pre-operative creatinine (OR: 2.5 95% CI: 1.3-4.6, p=0.004). Higher mean preoperative CHADS 2 (3.0 +/- 0.01 vs 2.4 +/- 0.5, p=0.01) and mean preoperative R 2 CHADS 2 (5.0 +/- 0.01 vs 4.4 +/- 0.5, p=0.01) scores were associated with POAF as compared to non-POAF. Conclusion: In patients undergoing continuous-flow left ventricular assist device implantation, postoperative atrial fibrillation was associated with higher rates of early mortality but not postoperative stroke or long-term mortality. Furthermore, higher preoperative CHADS 2 and R 2 CHADS 2 scores were associated with postoperative atrial fibrillation. However, the only independent predictor of post-operative atrial fibrillation in this small cohort was elevated preoperative creatinine.

Purpose Stroke is one of the leading complications during CF-LVAD support. The purpose of this observational study was to investigate the temporal relationship of circulating homocysteine (Hcy) and oxidative stress as potential markers to identify CF-LVAD patients at risk for developing postoperative strokes. Methods We analyzed available blood samples from 24 selected subjects including non-heart failure control group(n=6) and heart-failure patients undergoing CF-LVAD implant(n=18). The CF-LVAD patients were selected in stroke group(n=6) those who developed stroke within a month after implant and were compared to selected matched patients who did not develop stroke(n=12). Baseline Hcy, malondialdehyde(MDA) and antioxidant were compared between groups. Weekly blood samples at 1,2,3 and 4 weeks were analyzed in selected stroke and no-stroke groups. Results At baseline, CF-LVAD patients had higher plasma Hcy and MDA and lower antioxidant than the control group(Fig1A-C). There was a significant 1.8-fold increase in baseline Hcy in stroke group compared to no-stroke group though there were no differences in the levels of MDA and antioxidant between them(Fig1A-C). In stroke group, post-implant levels of Hcy and MDA increased temporally and remained elevated while these trends were not seen in the no-stroke group(Fig1D-F). There was also a significant depletion in antioxidant in stroke group at week 4 compared to no-stroke group(Fig1F). Conclusion A near 2-fold rise in baseline Hcy was seen in stroke group patients compared to no-stroke patients, suggesting its utility as a potential biomarker to predict stroke risk after CF-LVAD implant. Elevated Hcy, oxidative stress and depleted antioxidant may be important indicators of systemic response of the body to CF-LVAD in patients who have stroke. These findings also suggest that vascular endothelial dysfunction may plan an important role in the development of stroke in CF-LVAD recipients.

Purpose Left ventricular assist devices (LVAD) are standard of care for management of end-stage heart failure. LVAD patients are on antiplatelet agents and long-term anticoagulation with warfarin to prevent thrombotic events. The ease of use, superior efficacy, and improved side effect profile have made direct oral anticoagulants (DOACs) the preferable anticoagulant for treatment of atrial fibrillation; but there is limited data regarding their safety and efficacy in patients with an LVAD. Methods In this multicenter retrospective analysis, LVAD patients who were switched to a DOAC after a trial of warfarin were compared to patients who remained on warfarin. The DOAC group included patients with a history of warfarin failure or noncompliance. Overall survival as well as thrombotic events (i.e. ischemic stroke, pump thrombosis) and bleeding events (i.e. intracranial or gastrointestinal (GI) bleed) were compared between the two groups. Non-parametric and semi-parametric cox multiple regression analysis were performed. Univariate screening was performed to identify co-variates to be included in the multivariable analysis when applicable. Results A total of 268 patients were included in the study (DOAC group: N=8, mean age=58±19 years, 75% male vs warfarin group: N=260, mean age=57±13 years, 81% male). The majority of the DOAC (75%) and all warfarin patients were on low-dose aspirin. There was no significant difference in mortality between the two groups (HR=2.0, P=0.2; adjusted HR=2.3, P=0.1) (Figure 1A). There were no statistically significant differences in GI bleeding (HR=0.95, P=0.9; adjusted HR=1.1, P=0.9) and intracranial bleed (HR=1.5, P=0.7) (Figure 1B-C). Additionally, the rate of ischemic stroke (HR=1.5, P=0.7) and pump thrombosis were similar between the two groups (HR=0.9, P=0.9; adjusted HR=0.7, P=0.7) (Figure 1D-E). Conclusion Our findings suggest DOACs may provide a safe and effective alternative to warfarin in the life long anticoagulation of LVAD patients. Further studies are warranted.

Gallstone ileus due to erosion of one or more gallstones into the gastrointestinal tract is an uncommon cause of small bowel obstruction. The site of impaction is usually distal ileum, and less commonly the jejunum, colon, duodenum, or stomach. We report a rare case of gallstone ileus with impaction at the proximal small bowel and at a Meckel's diverticulum (MD) in a 64-year-old woman managed with laparoscopic converted to open small bowel resections. Patient was discharged home in stable condition and remained asymptomatic at 6-mo follow up. We review the current literature on surgical approaches to MD and gallstone ileus. Diverticulectomy or segmental resection is preferred for complicated MD. For gallstone ileus, simple enterolithotomy or segmental resection are the most the most favored especially in older co-morbid patients due to lower mortality rates and the rarity of recurrent gallstone ileus. In addition, laparoscopy has been increasingly reported as a safe approach to manage gallstone ileus.

BACKGROUND Valve selection in patients with end-stage renal disease (ESRD) is uncertain. We performed a systematic review and meta-analysis to compare clinical outcome in ESRD patients undergoing valve replacement. METHODS We systematically searched multiple databases (2000–October 2015) to identify original studies comparing adverse events between mechanical and biological valve replacement in ESRD patients. End-points studied were: postoperative mortality, bleeding events, need for re-operation, and late survival. A random-effect inverse-variance weighted analysis was performed; event rates are compared as odds ratio (OR and 95% confidence interval) and hazard ratios (HR) for time-to-event data. Mechanical valve and tissue valve replacement were considered as study and control cohorts, respectively. RESULTS Fifteen retrospective studies (5523 mechanical and 1600 tissue valve) were included in our meta-analysis. Early mortality was comparable (OR 1.15 [0.77; 1.72]; p = 0.49). The mean follow-up among studies ranged from 1.6–15 years. Bleeding was significantly higher after mechanical valve replacement (OR 2.55 [1.53; 4.26]; p = 0.0003). Structural valve degeneration was present in only 0.6% patients after a tissue valve replacement. Overall survival after valve replacement was poor (median 2.61 years); valve choice did not influence this outcome (pooled HR 0.87 [0.73; 1.04]; p = 0.14). CONCLUSION Operative mortality in ESRD patients is comparable between mechanical and tissue valve replacement. Major bleeding episodes are significantly higher after mechanical valve replacement but structural degeneration in tissue valves during the follow-up period is low. Based on the findings from this meta-analysis, we would recommend using tissue valves in patients with ESRD.

Ventricular assist device (VAD) technology is being increasingly used for circulatory support and refractory heart failure. Known complications of VAD technology including bleeding and thrombosis. We report a rare case of acute mesenteric ischemia in a VAD patient, who was successfully treated with segmental small bowel resections.

Purpose Examine gender differences continuous-flow left ventricular assist device (CF-LVAD) recipients. Methods Retrospective review of 695 patients receiving a CF-LVAD from 11/2003 to 08/2017, of which 551 (79.3%) were male and 144 (20.7%) were female. Genders were compared after propensity score matching for age ≥50 yrs, diagnosis, body surface area, INTERMACS class, comorbidities, prior mechanical circulatory support, and prior sternotomy. Survival and outcomes were compared between 139 matched gender pairs. Results After matching, no difference was seen in baseline characteristics (Table 1). A competing risk analysis showed that women had a non-significant increase in mortality (p=0.065) (Figure 1). Women had higher rates of right ventricular assist device support (3.4% vs 0.8%, p=0.03) and there was a trend towards higher rates of stroke, LVAD exchange, and longer length of stay. Additionally, lower rates of drive line infection and transplantation in women were seen (Table 2). Conclusion Larger studies are needed to determine if these single center findings of increased probability of mortality amongst women are reproducible. Additionally, further study should be devoted to risk factors for postoperative right heart failure among women.

Background: The development of stroke while on continuous flow left ventricular assist device (CF-LVAD) remains a source of significant morbidity and mortality. The ability to risk stratify these patients can improve postoperative management. Objective: To describe the overall experience of cerebrovascular accidents in CF-LVAD patients at a large volume tertiary center and compare the utility of CHADS 2 , CHA 2 DS 2 -VASc, and R 2 CHADS 2 scores. Methods: A retrospective analysis of 522 patients (524 CF-LVADs: HeartMate-II=402; Heartware=122), between 2003 and 2016, was conducted. Post-operative heparin for 2-3 days, warfarin (goal INR 2-3), and 80-325mg aspirin were administered daily. Cerebrovascular vascular accident (CVA) was defined as any focal or global deficit with positive imaging. The CHADS 2 , R 2 CHADS 2 and CHA 2 DS 2 -VASc scores were calculated. Baseline characteristics and risk assessment scores were compared between patients with ischemic CVA (ICVA) and no CVA (nCVA). Kaplan-Meier analysis was conducted. Results: Mean age was 54.7±13.6 years, 21.8% were female and 44.8% had ischemic cardiomyopathy. Eighty patients (15.3%) had 98 events of ICVA. Median duration between implant and ICVA was 127 [range 1-2226] days. Hemorrhagic conversion occurred in 9 (9.2%) patients. The CHADS 2 (ICVA=2.4±1.0, nCVA=2.3±1.1, p-value=0.53), CHA 2 DS 2 -VASc (ICVA=3.2±1.3, nCVA=2.9±1.3, p-value=0.08) and R 2 CHADS 2 (ICVA=3.5±1.5, nCVA=3.2±1.6, p-value=0.22) were all higher for ICVA cohort. Patients with multiple ICVAs had a mean CHADS 2 score of 2.5±0.74, CHA 2 DS 2 -VASc score of 3.5±1.1, and R 2 CHADS 2 score of 4±1.2. Freedom from stroke was significantly lower in the CHA 2 DS 2 -VASc ≥3 compared to the CHA 2 DS 2 -VASc Conclusion: CHA 2 DS 2 -VASc of ≥3 was associated with ICVA in this cohort of CF-LVAD patients. Specifically tailored risk-scores are needed to better predict those at risk for neurological events in CF-LVADs

Purpose We assessed the impact of blood loss and transfusion volume on right ventricular failure (RVF) requiring right-sided mechanical circulatory support (R-MCS) after continuous flow left ventricular assist device (CF-LVAD) implantation. Methods Retrospective review of 434 patients with CF-LVAD implantation from 2003 to 2017. Intraoperative blood loss, postoperative blood loss, and intraoperative transfusion volume was assessed for patients requiring R-MCS. Results Mean patient age was 55.2±13.6 years. Heartware HVAD was inserted in 100 (23.0%) and HeartMate II in 334 (77.0%) patients. Of these, 49 (11.3%) patients required R-MCS. R-MCS placed within 24 hours of CF-LVAD (N=20, 4.6%) had significantly more intraoperative and postoperative blood loss, and received a significantly higher quantity of intraoperative blood products compared to patients who did not require R-MCS within 24 hours (Table 1). HeartMate II patients had higher 24 hour blood loss (3398.3±3721.6 vs 1621.2±1243.4 ml, p Conclusion Intraoperative and postoperative blood loss as well as intraoperative transfusions were associated with development of early RVF requiring R-MCS. This highlights the importance of reducing coagulopathy and its associated need for transfusions in patients at risk for early R-MCS.

Purpose Patients with advanced heart failure and cardiorenal syndrome can experience significantly elevation in blood urea nitrogen (BUN) levels. We evaluated the impact of preoperative elevated BUN levels on bleeding and survival in patients who underwent continuous flow - left ventricular assist device (CF-LVAD) implantation. Methods We performed a retrospective review of 737 patients who underwent implantation of CF-LVADs from December 1999 through August 2017 at our center. Preoperative hemodynamics, perioperative characteristics, and postoperative outcomes were compared between patients with BUN ≥60 mmol/L and those Results Of the 664 patients included in the study (73 were excluded due to incomplete data), 53 patients had a BUN ≥60 mmol/L (mean: 83±28) and 611 patients had a BUN Conclusion Preoperative elevation in BUN above 60 mmol/L was associated with higher mortality. Additional studies are warranted to determine whether preoperative optimization of the uremia with medical therapy and/or dialysis can impact the increased risk of mortality.

Purpose Patients with end-stage heart failure on left ventricular assist devices are predisposed to stroke. Preoperative factors associated with increased stroke risk are poorly understood. Methods Single-center retrospective review of 725 patients from 2000 to 2017 who received a continuous flow left ventricular assist device (CF-LVAD) at our institution. Logistic regression analysis was performed to determine independent predictors of ischemic and hemorrhagic stroke . Results Mean age was 54.0±13.7 years, most patients were male 573 (79.0%), and most were implanted as a bridge to transplant 421 (58.1%) (Table 1). Of these, 118 (16.3%) patients had an ischemic stroke at a median follow-up of 128 (Range:1-4042, IQR 36-456) days. A history of diabetes was independently associated with an ischemic stroke (HR 1.7 95% CI 1.1 to 2.6, p=0.01). Hemorrhagic stroke , excluding ischemic conversions (N=16, 2.2%), occurred in 86 (11.9%) patients at a median follow up of 281 (Range:5-2436, IQR 92-698) days. Female gender (HR 1.9 95% CI 1.1 to 3.4, p=0.02) and INTERMACS class I (HR 2.2 95% CI 1.3 to 3.7, p=0.04) were independently associated with development of hemorrhagic stroke while on CF-LVAD support. Patients with ischemic and hemorrhagic stroke had significantly lower survival compared to patients without postoperative stroke (Figure 1). Conclusion The temporal pattern and risk factor profile for ischemic stroke is distinctly different from that of hemorrhagic stroke in patients on CF-LVAD support. This may be useful in preoperative risk stratification and postoperative risk reduction.

Purpose We identified the impact of vasoplegia after left ventricular assist device (LVAD) on postoperative outcomes and predictors of postoperative vasoplegia. Methods Retrospective review of 624 patients who had continuous flow LVAD implantation from 2005-2017 at our institution. Mild, moderate, or severe vasoplegia was determined with the vasoactive score (VS) [dopamine+100 x epinephrine + 100 x norepinephrine + 10000 x vasopressin] (U/kg/min), with a VS of 28 being severe. Mean VS was calculated at 0-6 hrs, 6-12 hrs, and 12-24 hrs postoperatively. Results Mean age was similar for vasoplegic and non-vasoplgic patients (Table 1). Vasoplegia was observed in 134 (21.5%) patients. Reoperation for bleeding and 30-day mortality were higher in vasoplegic patients (Table 1). VS at 12-24 hrs had a greater association with 30-day mortality compared to VS at 0-6 or 6-12 hrs (AUC 0.72 vs 0.69 vs 0.65; p creatinine , prolonged cardiopulmonary bypass time, preoperative beta blocker use and preoperative mechanical circulatory support . Conclusion Moderate to severe vasoplegia at 12 to 24 hrs postoperatively is associated with significantly worse survival after CF-LVAD implantation. Modifiable risk factors identified in this study should be optimized to reduce risk of vasoplegia.

Purpose Infection is a frequent problem following CF-LVAD implantation. We were interested in determining the spectrum of infectious complications following implantation of HeartMate II (HMII) and Heartware (HW) CF-LVADs. Methods We reviewed 893 HMII and HW implants from 1999 to 2018 performed at our institution. Infections were classified as device-specific (superficial/deep driveline infection or pocket/device infection) or as device-related (bacteremia). Other infections, such as urinary tract infections, central line infections, and pneumonia were recorded, but are not analyzed here. Etiology of the infection was also recorded. In some infections, multiple infectious agents were cultured. Results 801 CF-LVADs were implanted; 542 HMIIs, and 256 HWs. 180/542 (33.2%) of HMII, and 70/256 (27.3%) of HW pumps developed an infection. The incidence of infection / support year was 20.6% for HMII pumps and 20.3% for HW pumps. Driveline infections (superficial or deep) occurred in 136/542 (25.1%) HMII implants and in 53/250 (21.2%) HW implants. Pocket/device infections occurred in 102/542 (18,8%) HMII pumps and in 23/256 (9.0%) HW pumps. Bacteremia occurred in 84/542 (15.1%) HMII pumps and in 28/256 (10.9%) HW pumps. Staph aureus, pseudomonas, and coagulase negative species were the most common isolates (see Table). Median time to first infection was not statistically different (p=748) between HMII (1021 days) and HW devices (1273 days); (See Figure). Conclusion Infection continues to be a major problem after CF-LVAD implantation. Driveline infections, both superficial and deep, as well as pocket and device infections occur commonly after both HMII and HW implants.

BACKGROUND Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) for patients with severe symptomatic aortic stenosis (AS) who are at intermediate and high risk for surgery. Commercial use of TAVR has expanded to patients with end stage renal disease (ESRD). OBJECTIVES Compare in-hospital outcomes of TAVR versus SAVR in ESRD patients requiring hemodialysis (HD). METHODS ESRD patients on HD undergoing TAVR (n = 328) or SAVR (n = 697) between 2012 and 2014 were identified in the National Inpatient Sample (NIS). Propensity-score matching method was used to minimize selection bias. Baseline characteristics and in-hospital outcomes were compared. RESULTS TAVR patients were older (75.3 vs. 61.6 years, P

Study Right ventricular assist devices (RVAD) are commonly used for severe right heart failure (RHF) after continuous flow left ventricular assist device (CF-LVAD) insertion. However, the timing of RVAD insertion and the associated outcomes in CF-LVAD patients remains unclear. This study evaluates the effect of timing of RVAD insertion on long-term outcomes of CF-LVAD patients. Methods We performed a retrospective review CF-LVAD implantations from Jan 2001 through Mar 2017 at our center. From this, we culled out patients who received an RVAD and divided this cohort into early insertion (≤24 hours after CF-LVAD placement) and delayed insertion (>24 hours and ≤30days after CF-LVAD placement) groups. We compared early and late outcomes in the two groups. Results Within the CF-LVAD placement cohort (n=692), 61 (8.82%) patients required RVAD for severe RHF, with 35 (57.4%) patients in the early insertion group and 26 (42.6%) in the delayed insertion group. The majority of patients received temporary-type RVADs (CentriMag=42, TandemHeart=3) while some received durable-type RVADs (HeartWare=5, HeartMateII=1, Abiomed5000=4, Jarvik2000=1, Thoratec PVAD=3, Biomedicus=1). The mean duration of RVAD support was 48.8 days. In the early group, 17 (48.6%) patients were successfully weaned vs. 10 (38.5%) in the delayed group (p=NS). Overall differences between the early and late group have been summarized in Table 1 . Thirty-day mortality was similar for early 19 (54.3%) vs. delayed group 15 (57.7%) (p=NS) (Figure 1). There was no significant difference between the two groups in successfully bridging to transplantation. The 12-month overall survival rate in early placement patients was 16.7% and 26.9% in the delayed placement patients (p=NS) (Figure 1). Conclusions In this cohort of patients, no significant differences were found between the early and delayed groups in length of stay or 30-day readmission rates. There is no effect of timing of RVAD insertion on long-term outcomes of CF-LVAD patients. Prospective randomized trials can be designed to answer this equipoise effectively.

Purpose Left ventricular assist devices (LVADs) are a popular option for left ventricular support in bridging patients to heart transplantation or as destination therapy. However, the effect of heart failure etiology on outcomes after LVAD implantation has not yet been elucidated. Methods Between 2008 and 2018, a total of 549 patients with either ischemic cardiomyopathy (ICM) or nonischemic cardiomyopathy (NICM) underwent implantation of a continuous-flow LVAD our institution. ICM was defined by history of myocardial infarction or revascularization, coronary angiography showing ≥75% stenosis of the left main or proximal left anterior descending coronary arteries or ≥75% stenosis of two or more epicardial vessels. We identified 301 (54.8%) patients with NICM and 248 (45.2%) patients with ICM, and compared postoperative survival and adverse events in patients with ICM versus NICM. Results NICM patients were more likely to be female (22.9% vs 17.8%, p=0.08). Survival was similar between both groups with 30 day, 6 month, and 1 year survivals of 93%, 81%, and 72%, respectively, for ICM patients versus 91%, 81%, and 74%, respectively, for NICM patients (p=0.5) (Figure 1). Etiology of heart failure was not an independent predictor of survival in multivariate logistic regression analysis (p=0.84). There was no significant difference in adverse events including stroke, sepsis, or pump infection between the two groups. Conclusion The etiology of heart failure did not appear to significantly affect outcomes after LVAD implantation.

Purpose Continuous flow left ventricular assist device (CF-LVAD) support has been associated with high rates of gastrointestinal bleeding (GIB). We analyzed the ability of the R2CHA2DS2 VASc scoring system to predict GIB in patients on CF-LVAD support. Methods We performed a retrospective review of 526 patients who underwent implantation of CF-LVADs from November 2003 through March 2016 at our center. The R2 CHA2DS2 VASc score was calculated preoperatively for each patient, and logistic regression analysis and receiver operating characteristic (ROC) curve analysis were performed to determine whether this risk score predicted GIB. Additional analyses were performed using the R2 CHA2DS2 VASc score to identify etiologies and locations of GIB. Results R2CHA2DS2 VASc score was calculated for 519 patients; 7 patients were excluded due to incomplete data. Average score was 5.1±1.4 (Figure). A total of 218 GIB event occurred in 140 patients; 48 experienced a recurrent GIB. Median time to GIB event was 78 days (interquartile range = 36.5-2298.75 days). The most common etiology was atriovenous malformations (72 events in 50 patients). The R2 CHA2DS2 VASc score successfully predicted GIB (Odds ratio [OR]=1.4, p=0.001) and was especially significant for GIB from ulcers (OR=1.4, p=0.002) and AVMs (OR=1.5, p=0.001) in the stomach (OR=1.3, p=0.004) and duodenum (OR=1.5, p=0.02; Table). ROC curve analysis resulted in an area under the curve of 0.63. Conclusion The R2 CHA2DS2 VASc risk score accurately predicted GIB events in CF-LVAD recipients from AVMs and ulcers in the stomach and duodenum. This may be useful in the selection and management of patients being considered for LVAD implantation.

Purpose The gold standard for anticoagulation in patients with continuous flow left ventricular assist device (CF-LVADs) is warfarin. However, many patients fail warfarin therapy due to thromboembolic and bleeding events. Warfarin requires regular monitoring and dosage adjustments, and is associated with significant patient time outside recommended therapeutic INR range. Novel oral anticoagulation (NOAC) has been shown to be non-inferior compared to warfarin in stroke prevention with less intracranial hemorrhage in patients with atrial fibrillation. In this study, we sought to evaluate the safety and efficacy of NOACs in patients with CF-LVADs after failed warfarin therapy. Methods Patients who underwent CF-LVAD insertion between 2008 and 2018 were identified in a single-center database. 7 patients with either HeartMate II or HeartWare were switched from warfarin to a NOAC, either apixaban or rivaroxaban, were included. Occurrence of stroke, non-CNS embolism, pump thrombosis, and major GI bleeding or intracranial hemorrhage on warfarin and NOAC were evaluated. Results 5 of 7 patients were male, with an average BMI of 30. Common comorbidities were hypertension (100%), diabetes mellitus (57%) and ischemic cardiomyopathy (57%). There were a total of 3968 patient days on warfarin and 1459 patient days on a NOAC. Patients on warfarin therapy spent an average time of 30% within a therapeutic INR range. The rates of complications under warfarin versus NOAC therapy were: strokes 0.019 vs. 0 /patient-year, non-CNS embolism 0.019 vs. 0 /patient-year, pump thrombosis 0.01 vs. 0 /patient-year, major GI bleeding 0.02 vs. 0.07 /patient-year, and intracranial hemorrhage 0.019 vs. 0 /patient-year.(Table 1). Conclusion Increased complication rates and poor time in therapeutic INR range were present in patients receiving warfarin therapy after CF-LVAD insertion. NOAC therapy with apixaban or rivaroxaban may be a viable alternative. However, large prospective studies are necessary to confirm these results.

Purpose Continuous flow left ventricular assist device (CF-LVAD) support has been associated with gastrointestinal bleeding (GIB), primarily from arteriovenous malformations or ulcers, and exacerbated by the requirement for anticoagulation. In this report, we explore whether GIB persisted after heart transplant in patients who experienced GIB events while on CF-LVAD support. Methods We performed a retrospective review of 701 patients who underwent implantation of CF-LVADs from August 2002 through August 2017 at our center, and identified patients who underwent CF-LVAD implantation as a Bridge-to-Transplant, experienced at least one GIB event during CF-LVAD support, and were successfully bridged to heart transplantation. We evaluated the incidence of GIB events in these patients after heart transplantation. Results A total of 46 heart transplant recipients fit the inclusion criteria. There were a total of 63 total GIB events while on CF-LVAD support. Locations of GIB events included esophagus (N=3), stomach (N=21), duodenum (N=7), jejunum (N=3), small intestine not-otherwise-specified (N=12), colon (N=14), and rectum (N=3). Etiologies included gastritis (N=10), ulcer (N=11), arteriovenous malformation (N=13), angiodysplasia (N=3), polyp (N=2), diverticulosis (N=8), and Mallory Wiess tear (N=2). Mean LVAD support time was 1.4±1.5 years (65.4 cumulative patient-years). Mean follow-up time after transplantation was 4.0±3.5 years (183.3 cumulative patient-years after transplantation). There was only 1 GIB event after heart transplantation (events per patient-year: 0.005). The etiology was non-specific acute colitis in a patient who had prior GIB from a gastric ulcer while on LVAD therapy. Time from transplant to GIB event was 3.9 years. The patient was taking aspirin 81mg daily at the time of GIB. Conclusion GIB during CF-LVAD therapy did not persist after heart transplantation. This may be due to restoration of pulsatile flow. Introduction of a greater degree of pulsatility into LVAD flow technology may improve the incidence of GIB while on CF-LVAD support.

Purpose Recent studies involving partial-support ventricular assist device (VADs) have suggested INTERMACS Profiles may be used as a means of identifying patients with less severe heart failure who require lower flow rates. We explore which preoperative factors are predictive of continuous-flow left VAD (CF-LVAD) flow requirements at discharge. Methods Retrospective review of 206 patients who underwent primary implantation of CF-LVAD from May 2013 through August 2017 at our center and survived to discharge. We performed step-wise multiple linear regression analysis on preoperative factors to identify factors that predicted CF-LVAD flow rates at the time of discharge. Results Of the 206 patients in our study, 27 (13.1%) were INTERMACS Profile 1, 53 (25.7%) were Profile 2, 95 (46.1%) were Profile 3, 14 were Profile 4, and 17 (6.8%) were Profile 5-7. Mean flow rates at discharge were 5.3±1.3, 5.3±1.6, 4.9±1.3, 5.3±1.2, and 5.8±1.0 L/min, respectively. Linear regression analysis showed INTERMACS Profile was not correlated with LVAD flow (p=0.73). Age (Regression Coefficient [RC] = -0.03, p=0.009), body surface area (BSA; RC = 0.23, p=0.03), creatinine (RC = 0.40, p=0.02) and mean right atrial pressure (RC = 0.05, p=0.02) were significantly correlated with higher flow rates (Table). Conclusion INTERMACS Profile was not a predictor of required flow rates for patients on CF-LVAD support at the time of discharge. Younger age, higher BSA, and preoperative creatinine and mean right atrial pressure predicted greater flow requirements. Further studies are warranted to devise predictive models of CF-LVAD flow requirements.