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Introduction: We aimed to assess the impact of digoxin use following left ventricular assist device (LVAD) implantation on clinical outcomes., Methods: Patients implanted with continuous flow LVADs at a single academic medical center and survived to initial hospital discharge were included in the analysis ( n  = 346). Clinical events were captured at a maximum of 2 years of follow up. Digoxin use was defined as 30-day continuous use post-LVAD. Negative binomial regression and Kaplan-Meier method were used to assess the association between digoxin use and clinical outcomes., Results: Mean age of the cohort was 56 years (±13) and 23% (79/346) were female sex. Digoxin was used in 144 patients (41.6%) for a median of 268 days (IQR 154, 616). Digoxin use was associated with a significant reduction in cumulative incidence of gastrointestinal bleeding (GIB) (15% vs 26%, p  = 0.004). After adjusting for age, hypertension, post-operative hemoglobin, RDW, potassium, and GFR, and use of angiotensin receptor/neprilysin inhibitor, there remained a significant 47% reduction in GIB incidence in patients treated with digoxin. There was no significant difference in cumulative incidence in right ventricular failure (RVF) between the two groups. There was no difference in overall 2-year survival between groups., Conclusions: Digoxin use was associated with reduction in GIB events, but not in RVF or mortality. Further studies are needed to confirm these findings and to investigate optimal timing and patient population.

While cytomegalovirus (CMV) reactivation occurs in immunocompetent patients who are critically ill and has been associated with worse outcomes, very few cases of CMV reactivation have been reported following left ventricular assist device (LVAD) implantation. We aimed to evaluate the incidence and risk factors for CMV reactivation following LVAD implantation. Retrospective chart review of patients who had undergone LVAD implantation between July 2004 and December 2018 was performed. Cases with CMV reactivation post-LVAD were randomly matched (1:2) by sex, LVAD type, and implant year with controls utilizing SAS macros. Fisher's exact and paired sample t-tests were performed to evaluate for differences between categorical and continuous variables, respectively. Days to reactivation post-LVAD implantation were calculated in cases, and the corresponding times post-LVAD implantation were determined in control patients for variable comparisons. Survival analysis was performed using the Kaplan-Meier method. Of the 349 patients reviewed, 208 (59.6%) patients were seropositive for CMV before LVAD implantation. Of these 208 patients, eight (3.8%) had CMV reactivation following LVAD implantation. The median time to CMV reactivation following LVAD implantation was 21.5 days (range, 6-177). Six (75%) patients had CMV viremia, and the other two had colitis and pneumonia without viremia. In comparison to controls, patients with CMV had higher creatinine levels (p = 0.039) and higher RDW (p = 0.05) and were more likely to have received steroids within the previous week (p = 0.028) and to have concurrent bacterial infection (p = 0.001). CMV reactivation following LVAD implantation is more frequent than expected. Early testing, diagnosis, and treatment in at-risk patients (i.e., renal failure, steroid use, elevated RDW) might improve clinical outcomes., Competing Interests: The authors have no relevant conflicts of interest to disclose. The authors received no internal or external funding to conduct this study., (Copyright © ASAIO 2020.)

Gastrointestinal bleeding (GIB) is a common cause of morbidity among patients supported by left ventricular assist devices (LVADs). The aim of this study was to identify if pre-LVAD right ventricular (RV) dysfunction is associated with risk of GIB after LVAD implantation. Of 398 patients implanted with LVADs between July 2008 and July 2016, 130 (33%) developed GIB at a median of 2.6 months following LVAD implantation. Arteriovenous malformations (AVMs) were found in 42 (34%) GIB patients. Patients with GIB were older and more likely to have hypertension, diabetes, and ischemic cardiomyopathy. On pre-LVAD echocardiography, GIB patients had increased RV diastolic dimension (4.7 ± 0.8 vs. 4.4 ± 0.9 cm, p = 0.02), a higher rate of greater than mild tricuspid valve (TV) regurgitation (73 [60%] vs. 120 [47%], p = 0.006), and underwent TV repair more often (38 [30%] vs. 43 [16%], p = 0.0006) during LVAD implantation. After multivariable adjustment, preoperative greater than mild RV enlargement (hazard ratio [HR] 2.32, 95% CI 1.12-5.03; p = 0.03), TV regurgitation (HR 1.83, CI 1.02-3.44; p = 0.01), and TV repair (HR 3.76, confidence interval [CI] 1.02-4.44; p = 0.01) remained associated with risk of GIB. This finding was driven by the AVM-GIB subgroup. Preoperative RV enlargement and TV regurgitation are associated with post-LVAD AVM-related GIB., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © ASAIO 2020.)

Left ventricular assist device (LVAD) deactivation may be considered in cases of left ventricular recovery, pump thrombosis, infection, and end-of-life palliation. Surgical pump explantation remains the principal method, but percutaneous deactivation presents a safe and effective alternative. We have developed a formal program for percutaneous LVAD deactivation within our advanced heart failure program including patient selection criteria, preprocedure testing, a procedural algorithm, and a postprocedure care plan. Patient selection for percutaneous LVAD deactivation required review by an interdisciplinary heart transplant team including reason for deactivation, cardiac function, surgical risk, and patient preference. All candidates underwent LVAD ramp studies with both transthoracic echocardiography and right heart catheterization assessment. Deactivation was performed under general anesthesia with transesophageal echocardiography guidance. Three Amplatzer Vascular Plug IIs (Abbott, St. Paul, MN) were deployed in the LVAD outflow cannula with the proximal edge of the third plug aligned with the aortic anastomosis of the graft as guided by angiography and 3-dimensional transesophageal echocardiography. In a separate procedure, the LVAD drive line was transected below the skin, which was closed surgically over the driveline stump. Anticoagulation was continued for at least 3 months. Since initiation in January 2017, our program has performed 7 percutaneous LVAD deactivation procedures. All procedures have been successful, 5 of the patients remain medically managed, and 2 have proceeded to heart transplant. Percutaneous LVAD deactivation provides an alternative to surgical explantation. A percutaneous LVAD deactivation program is an important component of an advanced heart failure program., (Copyright © 2020. Published by Elsevier Inc.)

In selected patients with left ventricular assist device-associated infection or malfunction, pump exchange may become necessary after conservative treatment options fail and heart transplantation is not readily available. We examined the survival and complication rate in patients (⩾19 years of age) who underwent HeartMate II to HeartMate II exchange at our institution from 1 January 2010 to 28 February 2018. Clinical outcomes were analyzed and compared for patients who underwent exchange for pump thrombosis (14 patients), breach of driveline integrity (5 patients), and device-associated infection (2 patients). There were no differences in 30-day mortality (p = 0.58), need for temporary renal replacement therapy (p = 0.58), right ventricular mechanical support (p = 0.11), and postoperative stroke (p = 0.80) among groups. Survival at 1 year was 90% ± 7% for the whole cohort and 85% ± 10% for those who underwent exchange for pump thrombosis. In patients exchanged for device thrombosis, freedom from re-thrombosis and survival free from pump re-thrombosis at 1 year were 49% ± 16% and 42% ± 15%, respectively. No association of demographic and clinical variables with the risk of recurrent pump thrombosis after the first exchange was identified. Survival after left ventricular assist device exchange compares well with published results after primary left ventricular assist device implantation. However, recurrence of thrombosis was common among patients who required a left ventricular assist device exchange due to pump thrombosis. In this sub-group, consideration should be given to alternative strategies to improve the outcomes.

Background: Pulmonary hypertension secondary to left heart disease (WHO Group 2) is a known risk factor in patients with heart failure. The favourable effect of left ventricular assist devices (LVAD) on pulmonary hypertension has been demonstrated before, although this effect has not been well-studied in advanced pulmonary arterial bed disease with a significant elevation in pulmonary vascular resistance., Methods: We reviewed the records of 258 LVAD patients in our institution. Patients with elevated mean pulmonary artery pressure (mPAP>25mmHg) and elevated pulmonary vascular resistance (PVR ≥3 Wood units) were included in the study. Patients were divided into two groups based on their baseline PVR (PVR=3-5 Wood units (WU) vs. PVR>5WU). The groups were studied for the changes in their pulmonary haemodynamics after the placement of LVAD., Results: Fifty-one (51) patients were included in the study. All patients showed a significant improvement in their pulmonary haemodynamic parameters post LVAD placement. In the group with the higher PVR, mPAP dropped from a baseline of 43±7mmHg to 22±6mmHg post LVAD placement (p<0.001), while PVR dropped from 6.3±1.2 Wood units to 2.2±1.1 Wood units (p<0.001). In a subgroup of patients who underwent cardiac transplantation post LVAD (n=14), all patients maintained a normalised PVR (<3WU) one year post cardiac transplantation., Conclusions: Left ventricular assist devices can reverse pulmonary hypertension WHO Group 2 with significantly elevated PVR; this effect is not dependent on the baseline PVR, and is maintained up to one year post cardiac transplantation., (Copyright © 2018 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

Psychosocial factors have been show to impact survival and outcomes in a number of different diseases, including heart failure and patients receiving heart transplantation. With the increasing utilization of these devices, it is important to identify risk factors that could impact post-left ventricular assist device (LVAD) outcomes. This study was a single center, retrospective analysis of 238 patients who underwent implantation of a LVAD between July 27, 2004, and July 21, 2016, at The University of Nebraska Medical Center. Data collected include length of stay, number of readmission, alive status at 30 days, 180 days, and 1 year, as well as multiple psychosocial factors including history of drug abuse, history of alcohol abuse, history of noncompliance, history of anxiety, and history of depression, among others. Outcomes were calculated using univariate and multivariate analyses with SAS Version 9.4. None of the psychosocial factors assessed in this study showed statistical significance in predicting 30 day or 6 month mortality, but patients who smoked at the time of admission for LVAD implantation had higher mortality at 1 year (odds ratio 4.6, 95% confidence interval, 1.226-15.898, p = 0.011.) Patients with a diagnosis of depression had higher numbers of readmissions compared with those without depression (p = 0.048) with the number of readmissions further increased in patients with a diagnosis of both depression and anxiety (p = 0.0074). Psychosocial determinants do not appear to have a significant effect on mortality, but can result in increased risk of readmission if not adequately addressed before implantation and continually monitored postimplantation.

The aim of this study was to evaluate clinical outcomes after left ventricular assist device (LVAD) implantation in patients with severe pre-LVAD renal dysfunction (RD). The cohort of 165 consecutive patients implanted with HeartMate II LVADs was divided into two groups: 1) baseline glomerular filtration rate (bGFR) ≤ 40 ml/min/1.73 m (n = 30), and 2) GFR > 40 ml/min/1.73 m (n = 135). In both groups, GFR increased significantly at 1 month and then declined, remaining higher than the pre-LVAD level in the bGFR ≤ 40 group and returning back to the pre-LVAD level in the bGFR > 40 group by 1 year post-LVAD follow-up. Post-LVAD dialysis was used in 20% of the bGFR ≤ 40 patients and 7% of the bGFR > 40 patients (p = 0.02). By 3 months, 14% patients had GFR ≤ 40 ml/min/1.73 m. Grade ≥2 tricuspid regurgitation (TR) (odds ratio [OR], 3.4; 95% confidence interval [CI], 1.23-10.28; p = 0.02) and model for end-stage liver disease-XI score ≥ 17 (OR, 4.2; 95% CI, 1.45-12.24; p = 0.01) were risk factors for severe RD at 3 months after LVAD implantation. Eight bGFR ≤ 40 patients underwent heart transplantation. Carefully selected patients with advanced heart dysfunction and bGFR ≤ 40 ml/min/1.73 m can improve kidney function with LVAD support and be able to bridge to isolated heart transplantation. Additional research is needed to refine patient selection for LVAD.

Background: Adverse events (AEs), such as intracranial hemorrhage, thromboembolic event, and progressive aortic insufficiency, create substantial morbidity and mortality during continuous flow left ventricular assist device support yet their relation to blood pressure control is underexplored., Methods and Results: A multicenter retrospective review of patients supported for at least 30 days and ≤18 months by a continuous flow left ventricular assist device from June 2006 to December 2013 was conducted. All outpatient Doppler blood pressure (DOPBP) recordings were averaged up to the time of intracranial hemorrhage, thromboembolic event, or progressive aortic insufficiency. DOPBP was analyzed as a categorical variable grouped as high (>90 mm Hg; n=40), intermediate (80-90 mm Hg; n=52), and controlled (<80 mm Hg; n=31). Cumulative survival free from an AE was calculated using Kaplan-Meier curves and Cox hazard ratios were derived. Patients in the high DOPBP group had worse baseline renal function, lower angiotensin-converting enzyme inhibitor or angiotensin receptor blocker usage during continuous flow left ventricular assist device support, and a more prevalent history of hypertension. Twelve (30%) patients in the high DOPBP group had an AE, in comparison with 7 (13%) patients in the intermediate DOPBP group and only 1 (3%) in the controlled DOPBP group. The likelihood of an AE increased in patients with a high DOPBP (adjusted hazard ratios [95% confidence interval], 16.4 [1.8-147.3]; P=0.012 versus controlled and 2.6 [0.93-7.4]; P=0.068 versus intermediate). Overall, a similar association was noted for the risk of intracranial hemorrhage (P=0.015) and progressive aortic insufficiency (P=0.078) but not for thromboembolic event (P=0.638). Patients with an AE had a higher DOPBP (90±10 mm Hg) in comparison with those without an AE (85±10 mm Hg; P=0.05)., Conclusions: In a population at risk, higher DOPBP during continuous flow left ventricular assist device support was significantly associated with a composite of AEs., (© 2015 American Heart Association, Inc.)

Background: Heart failure is associated with reversal to a fetal gene expression pattern of contractile and metabolic genes. Substantial recovery of ventricular function with assist devices is rare. Our goal was to evaluate the effects of assist devices on fetal gene expression and hypoxia inducible factor-1 alpha (HIF-1 alpha), a transcriptional factor in hypoxic signaling., Methods: Human heart tissue was obtained from the left ventricular apex at the time of assist device implantation and again from the left ventricular free wall during cardiac transplantation. Non-failing tissue was obtained from unused hearts from human donors. Gene expression was measured with the Affymetrix 133 plus 2 Array. HIF-1 alpha was measured by Western blotting with commercially available antibodies., Results: Heart failure was associated with a decrease in alpha-myosin heavy chain and sarcoplasmic reticulum-Ca(2+) adenosine triphosphatase messenger RNA expression along with an increase in skeletal tropomyosin. This pattern persisted after assist device therapy. Heart failure was also associated with abnormalities in regulatory metabolic genes including glucose transporter 1 (GLUT1). These patterns also persisted after assist device therapy despite a reduction in atrial natriuretic peptide expression and normalization of HIF-1 alpha., Conclusions: Failure of assist devices to produce sustained recovery of myocardial contractile function may be due in part to persistent fetal transcriptional patterns of contractile and metabolic genes.