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Right ventricular (RV) failure is difficult to predict and is a major determinant of poor outcomes after left ventricular assist device (LVAD) implantation. We evaluated the associations of the following variables with severe RV failure in LVAD patients: tricuspid annular plane systolic excursion (TAPSE), pulmonary artery pulsatility index (PAPi), simplified RV contraction pressure index (sRVCPI), and HeartMate Risk Score (HMRS). We performed a retrospective case-control study on 216 patients who underwent continuous-flow LVAD implantation between 2008 and 2014. The primary analysis assessed the ability of HMRS, PAPi, sRVCPI, and TAPSE to predict severe RV failure. A secondary analysis evaluated the incremental benefit of combining predictive variables. Seventy-four patients developed severe RV failure (24%). Compared with the control group, the severe RV failure group had lower TAPSE (1.30 vs. 1.55; p < 0.001), lower PAPi (1.77 vs. 2.47; p = 0.001), lower sRVCPI (42.71 vs. 57.82; p < 0.001), and higher HMRS (2.12 vs. 1.65; p < 0.001). All four variables had similar receiver operating characteristic curves with modest area under the receiver operating characteristic curve (0.63-0.67, all p values < 0.001). In the evaluation of combined predictive variables, the combination of TAPSE with HMRS was found to be best for predicting severe RV failure. In summary, patients at risk for severe RV failure after LVAD implantation were successfully identified using TAPSE, PAPi, sRCPI, and HMRS. The combination of TAPSE and HMRS-incidentally, the least invasive and most readily available variables-proved to be superior to RV-centric metrics for predicting severe RV failure. The predictive and clinical use of these two variables should be tested prospectively.

Right heart failure is a potentially devastating complication of mechanical circulatory support, occurring at a rate of 0.49 events per 100 patient-months. Pulmonary vasodilators such as phosphodiesterase-5 inhibitors (PDE5i) have been frequently used to unload the right ventricle in left ventricular assist device (LVAD) patients, but there is scant evidence to support this practice., The purpose of this analysis is to provide additional data regarding the safety and efficacy of the PDE5i sildenafil in a real world population of patients supported with LVADs at Washington University in St. Louis. Sildenafil use was not associated with differences in gastrointestinal (GI) bleeding, stroke, mortality, heart failure (HF) admission, or orthotopic heart transplantation (OHT).

Frail patients are more prone to adverse events after cardiac surgery, particularly after implantation of left ventricular assist devices. Thus, frailty assessment may help identify patients unlikely to benefit from left ventricular assist device therapy. The purpose was to establish a suitable measure of frailty in adults with end-stage heart failure. In a prospective cohort of 75 patients (age 58 ± 12 years) with end-stage heart failure, we assessed the association between frailty (5-component Fried criteria) and the composite primary outcome of inpatient mortality or prolonged length of stay, as well as extubation status, time on ventilator, discharge status, and long-term mortality. Fried frailty criteria were met in 44 (59%) patients, but there was no association with the primary outcome (p = 0.10). However, an abridged set of 3 criteria (exhaustion, inactivity, and grip strength) was predictive of the primary outcome (odds ratio 2.9, 95% confidence interval 1.1 to 7.4), and of time to extubation and time to discharge. In patients with advanced heart failure, the 5-component Fried criteria may not be optimally sensitive to clinical differences. In conclusion, an abridged set of 3 frailty criteria was predictive of the primary outcome and several secondary outcomes, and may therefore be a clinically useful tool in this population., (Copyright © 2017. Published by Elsevier Inc.)

Current guidelines recommend adenosine diphosphate receptor inhibitors (ADPRi) be discontinued 5-7 days prior to cardiac surgery due to increased bleeding events, rates of re-exploration, and transfusions. However, the risks of left ventricular assist device (LVAD) implantation in patients taking an ADPRi have not previously been studied. We retrospectively identified 134 eligible patients with ischemic cardiomyopathy that underwent LVAD implantation between July 2009 and August 2013. The cohorts received an ADPRi ≤5 days of surgery (n = 25) versus >5 days prior or not at all (n = 109). Subgroup analyses adjusted for differences in frequency of redo sternotomy between cohorts, excluded patients that received an ADPRi >1 year prior to surgery, and excluded patients with a redo sternotomy. The ADPRi and control groups did not have significant differences in the primary outcomes, intraoperative PRBC units transfused (3.0 vs. 4.0, p = 0.12) or chest tube output within 24 h of surgery (1.66 L vs. 1.80 L, p = 0.61). After adjusting for differences in frequency of redo sternotomy (ADPRi vs. control, 12 vs. 52%, p ≤ 0.001), no significant difference in PRBC units transfused (3.1 vs. 3.5, p = 0.59) or chest tube output (2.04 L vs. 2.04 L, p = 0.98) was seen. No significant difference in 30-day mortality (8.0 vs. 11.0%, p = 0.63), 90-day mortality (16.4 vs. 23.3%, p = 0.42), or length of stay (29.0 vs. 28.0, p = 0.61) was seen. In this single-center experience, use of an ADPRi ≤5 days prior to LVAD implantation was not associated with increased bleeding, length of stay, or mortality.

Objectives: This study sought to assess the performance of the HeartMate Risk Score (HMRS) in a large multicenter cohort, with a focus on its performance as a function of disease severity., Background: The HMRS has been proposed as a simple tool for risk stratification of LVAD recipients, but subsequent studies have challenged its validity., Methods: We performed a retrospective, longitudinal, comparative study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) database. The HMRS was calculated for each patient and its association with mortality was assessed using Cox models, including a pre-specified interaction by INTERMACS profile groups (1 vs. 2 vs. 3 vs 4+)., Results: Among 10,847 patients with a mean age of 57.0 ± 12.9 years, 78.9 % were male; and 14.1%, 37.4%, 30.4%, and 18.2% were in INTERMACS profile groups 1, 2, 3, and ≥4, respectively. The HMRS showed moderate discrimination for both short-term (90-day, C-index 0.62) and long-term (2-years, C-index 0.60) mortality, with no significant difference between axial and centrifugal devices. Patients in the highest HMRS group had a relative risk of 90-day mortality 2.8 times greater than those in the lowest HMRS group (13.0% vs. 4.7%; p < 0.001). Importantly, the relative risks of higher HMRS scores were similar across INTERMACS profile groups, with subgroups of patients in INTERMACS profile 1 and 2 having comparable or lower mortality than some in INTERMACS profile 4+., Conclusions: The HMRS is a valid means of risk-stratifying patients across all INTERMACS profiles and may be superior to traditional INTERMACS classification. Risk stratification with the HMRS showed that patients within each INTERMACS profile groups have a wide spectrum of mortality risk and low INTERMACS profiles should therefore not be considered a contraindication to mechanical support., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The purpose of this study is to examine the association of sarcopenia as measured by psoas muscle area and outcomes in patients undergoing left ventricular assist device (LVAD) implantation. We retrospectively examined 333 consecutive patients who underwent implantation of a HeartMate II LVAD at our institution from June 2008 to August 2013. Patients were included if they had a perioperative computed tomography that spanned the L3-L4 vertebrae. Sarcopenia was defined as having the lowest tertile psoas muscle area by gender. The primary end point was the composite of inpatient death or prolonged length of stay of >30 days. One hundred patients met inclusion criteria. The psoas muscle area cut-off values for the lowest tertiles were 12.0 cm 2 for men and 6.5 cm 2 for women, resulting in 32 sarcopenic patients (32%). The primary outcome of inpatient death or prolonged length of stay occurred in 81% of patients in the sarcopenic versus 60% in the nonsarcopenic group (p = 0.043). There was a trend toward prolonged length of stay in sarcopenic patients but no difference in overall mortality. This demonstrates that sarcopenia as measured by psoas muscle area is associated with increased composite length of stay and mortality after LVAD implantation and may serve as correlate for frailty., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: We evaluated thrombotic and bleeding outcomes in patients with continuous-flow left ventricular assist devices (CF-LVADs), stratified by anticoagulation intensity. Previous studies of outpatients with CF-LVADs have suggested that target international normalized ratio (INR) values <2.5 (range, 2-3) may be used. However, recent studies reported an increase in pump thrombosis among CF-LVADs, especially within the first 6 months of implant., Methods and Results: We retrospectively reviewed 249 outpatients at our center who received a CF-LVAD between January 2005 and August 2013. Using Poisson models, we analyzed their 10 927 INRs to determine INR-specific rates of thrombotic (ischemic stroke and suspected pump thrombosis) and hemorrhagic (gastrointestinal bleeding and hemorrhagic stroke) events occurring outside of the hospital. In multivariate analyses, we adjusted for age, sex, atrial fibrillation, coronary disease, and LVAD type as time-dependent Cox proportional hazard models. During a mean follow-up of 17.6±13.6 months, thrombotic events occurred in 46 outpatients. The highest event rate (0.40 thrombotic events per patient-year) was in the INR range of <1.5, but INR values of 1.5 to 1.99 also had high rates (0.16 thrombotic events per patient-year). INR was inversely associated with thrombotic events (hazard ratio, 0.40; 95% confidence interval, 0.22-0.72; P=0.002). The optimal INR based on weighted mortality of thrombotic and bleeding events was 2.6., Conclusions: INR is inversely related to thrombotic events occurring outside of the hospital among patients supported with CF-LVADs. INR values <2.0 increase the rate of thrombotic events occurring outside of the hospital among patients supported with CF-LVADs., (© 2016 American Heart Association, Inc.)

Objectives: This study sought to determine whether severe right ventricular (RV) dysfunction in the pre-operative setting is associated with an increased risk of gastrointestinal bleeding (GIB) post-left ventricular assist device (LVAD)., Background: GIB is a significant complication in patients supported with continuous-flow LVADs. The impact of RV dysfunction on the risk of GIB has not been investigated., Methods: We retrospectively identified 212 patients who survived index hospitalization after implantation of HeartMate II (Thoratec Corp., Pleasanton, California) or Heartware HVAD (HeartWare Corp., Framingham, Massachusetts) from June 2009 to April 2013. Patients with severe RV dysfunction on pre-LVAD echocardiogram (n = 37) were compared to patients without severe RV dysfunction (n = 175). The primary outcome was freedom from GIB., Results: The majority of patients were male (79%) with a median INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile of 2 at LVAD implantation. There were no significant differences between cohorts with respect to demographics, comorbidities, device type, international normalization ratio, or aspirin strategy. During follow-up, 81 patients had GIB events: 23 of 37 (62%) in the severe RV dysfunction group versus 58 of 175 (33%) in the control group (p = 0.001). After adjustment for age and ischemic cardiomyopathy, severe RV dysfunction was associated with increased risk of GIB (hazard ratio: 1.799, 95% confidence interval: 1.089 to 2.973, p = 0.022)., Conclusions: In this single-center sample of patients supported with continuous-flow LVADs, severe RV dysfunction on pre-LVAD echocardiogram was associated with an increased risk of GIB. Further studies are needed to investigate possible mechanisms by which RV dysfunction increases the risk of GIB and to identify patient populations who may benefit from alterations in antithrombotic strategies., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study evaluated the Heartmate Risk Score (HMRS) and its potential benefits in clinical practice., Background: The HMRS has been shown to correlate with mortality in the cohort of patients enrolled in the Heartmate II trials, but its validity in unselected, "real world" populations remains unclear., Methods: This study identified a cohort of 269 consecutive patients who received a Heartmate II left ventricular assist device at our institution, the Barnes-Jewish Hospital in St. Louis, Missouri, between June 2005 and June 2013. Ninety-day and 2-year mortality rates, as well as frequency of several morbid events, were compared by retrospectively assigned HMRS category groups. The analysis was repeated within the subgroup of INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) class 1 patients., Results: Receiver operating curve analysis showed that the HMRS correlated with 90-day mortality with an area under the curve of 0.70. Stratification in low, mid, and high HMRS groups identified patients with increasing hazard of 90-day mortality, increasing long-term mortality, increasing rate of gastrointestinal bleeding events, and increasing median number of days spent in the hospital in the first year post implant. Within INTERMACS class 1 patients, those in the highest HMRS group were found to have a relative risk of 90-day mortality 5.7 times higher than those in the lowest HMRS group (39.1% vs. 6.9%, p = 0.029)., Conclusions: HMRS is a valid clinical tool to stratify risk of morbidity and mortality after implant of Heartmate II devices in unselected patients and can be used to predict short-term mortality risk in INTERMACS class 1 patients., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Stroke is a significant complication in patients supported with continuous-flow left ventricular assist devices (CF-LVAD) and hypertension is a significant risk factor for stroke, but the association between blood pressure and stroke in LVAD patients is not well characterized., Methods: We identified 275 consecutive patients who survived implant hospitalization between January 2005 and April 2013. Patients were grouped according to systolic blood pressure (SBP) as above a median and below a median of 100 mm Hg by their averaged systolic blood pressure during the 48 hours before discharge from implantation hospitalization. The groups were compared for the primary outcome of time to stroke., Results: The above-median SBP group had mean SBP of 110 mm Hg and the below-median SBP group had mean SBP of 95 mm Hg. There were no significant between-group differences in body mass index, smoking, vascular disease, hypertension, atrial fibrillation, or prior stroke. During a mean follow-up of 16 months, stroke occurred in 16% of the above-median SBP group vs in 7% of the below-median SBP group (hazard ratio, 2.38; 95% confidence interval, 1.11-5.11), with a similar proportion of hemorrhagic and ischemic strokes in each group. In Cox proportional hazard models adjusting for age, diabetes, or prior stroke, the hazard ratio remained statistically significant. SBP as a continuous variable predictor of stroke had an area under the curve of 0.64 in a receiver operating characteristic curve analysis., Conclusions: In this large, CF-LVAD cohort, elevated SBP was independently associated with a greater risk of subsequent stroke. These results identify management of hypertension as a potential modifiable risk factor for reducing the incidence of stroke in patients supported by CF-LVAD., (Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study evaluated clinical outcomes associated with erythropoiesis stimulating agent (ESA) use in left ventricular assist devices (LVAD)-supported patients., Background: Use of ESAs in patients with LVADs may minimize blood transfusions and decrease allosensitization. ESAs increase thrombotic events, which is concerning because LVADs are sensitive to pump thrombosis (PT)., Methods: We retrospectively reviewed 221 patients at our center who received a HeartMate II (Thoratec Corp., Pleasanton, California) LVAD between January 1, 2009 and June 6, 2013. Patients were divided into those who received ESAs during index admission (n = 121) and those who did not (n = 100). Suspected PT was defined as evidence of thrombus in the LVAD or severe hemolysis (lactate dehydrogenase >1,000 mg/dl or plasma-free hemoglobin >40 mg/dl). Outcomes were compared between cohorts using inverse probability-weighted analyses., Results: During a mean follow-up of 14.2 ± 11.9 months, suspected PT occurred in 37 patients (ESA 23%, no ESA 12%; p =0.03). The ESA cohort received ESAs 13.9 ± 60.9 days after LVAD implantation. At 180 days, event-free rates for suspected PT were ESA 78.6% versus no ESA 94.5% (p < 0.001). ESA use had higher rates of suspected PT (hazard ratio [HR]: 2.35; 95% confidence interval [CI]: 1.38 to 4.00; p = 0.002). For every 100-unit increase in cumulative ESA dosage, the hazard of suspected PT increased by 10% (HR: 1.10; 95% CI: 1.04 to 1.16; p < 0.001). After inverse probability weighting, ESA use was associated with a significantly higher rate of all-cause mortality (HR: 1.62; 95% CI: 1.12 to 2.33; p = 0.01)., Conclusions: ESA use in LVAD patients is associated with higher rates of suspected PT., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Electrocardiograms (ECGs) are routinely obtained in patients with advanced congestive heart failure (CHF) before and after surgical implantation with a left-ventricular assist device (LVAD). As the number of patients with CHF is increasing, it is necessary to characterize the changes present in the ECG of patients with LVADs., Methods: ECGs of 43 patients pre- and postimplantation of a HeartMate II LVAD were compared to characterize the presence of an LVAD using the following six criteria (LVADS2 ): low limb-lead voltage, ventricular pacing, artifact (electrical), duration of the QRS > 120 milliseconds, ST-elevation in the lateral leads, and splintering of the QRS complex. Additionally, 50 ECGs of non-LVAD patients coded as "lateral myocardial infarction (MI)" and 50 ECGs coded as "ventricular pacing" were chosen at random and scored. Odds ratios were calculated using Fisher's exact test. Logistic regression models were built to predict the presence of an LVAD in all patients., Results: Univariate analysis of the pre- and post-LVAD ECGs confirmed that all criteria except the "Duration of QRS > 120 milliseconds" characterized the ECG of a patient with an LVAD. Electrical artifact and low limb-lead voltage yielded the greatest association with an LVAD-ECG., Conclusions: The ECG of a patient with end-stage CHF significantly changes with LVAD implantation. The LVADS2 criteria provide a framework towards characterizing and establishing a new baseline of the ECG in a patient with a continuous-flow LVAD., (© 2014 Wiley Periodicals, Inc.)

Left ventricular assist device (LVAD)-supported patients are evaluated routinely with use of transthoracic echocardiography. Values of left ventricular unloading in this unique patient population are needed to evaluate LVAD function and assist in patient follow-up. We introduce a new M-mode measurement, the slope of the anterior mitral valve leaflet (SLAM), and compare its efficacy with that of other standard echocardiographically evaluated values for left ventricular loading, including E/e' and pulmonary artery systolic pressures. Average SLAM values were determined retrospectively for cohorts of random, non-LVAD patients with moderately to severely impaired left ventricular ejection fraction (LVEF) (<0.35, n=60). In addition, pre- and post-LVAD implantation echocardiographic images of 81 patients were reviewed. The average SLAM in patients with an LVEF <0.35 was 11.6 cm/s (95% confidence interval, 10.4-12.8); SLAM had a moderately strong correlation with E/e' in these patients. Implantation of LVADs significantly increased the SLAM from 7.3 ± 2.44 to 14.7 ± 5.01 cm/s (n=42, P <0.0001). The LVAD-supported patients readmitted for exacerbation of congestive heart failure exhibited decreased SLAM from 12 ± 3.93 to 7.3 ± 3.5 cm/s (n=6, P=0.041). In addition, a cutpoint of 10 cm/s distinguished random patients with LVEF <0.35 from those in end-stage congestive heart failure (pre-LVAD) with an 88% sensitivity and a 55% specificity. Evaluating ventricular unloading in LVAD patients remains challenging. Our novel M-mode value correlates with echocardiographic values of left ventricular filling in patients with moderate-to-severe systolic function and dynamically improves with the ventricular unloading of an LVAD.

Background: The purpose of this study is to comparatively analyze outcomes of heart transplant patients bridged to transplantation with HeartWare (HW-VAD) versus HeartMate II (HMII-VAD) left ventricular assist devices., Methods: The United Network for Organ Sharing Database was reviewed to identify first-time heart transplant recipients who were bridged to transplantation with either HW-VAD (n=141) or HMII-VAD (n=1824) from January 2009 through July 2012., Results: Recipients of HW-VAD had a higher proportion of female patients (27.0% versus 18.9%; p=0.019), a lower body surface area (2.01±0.25 m2 versus 2.06±0.25 m2; p=0.035), and a trend toward a higher peak percentage of panel reactive antibody against human leukocyte class I antigens (40.4%±32.8% versus 33.0%±30.4%; p=0.070). Pretransplantation recipient cardiac index (2.33±0.66 L⋅min(-1)⋅m(-2) versus 2.33±0.68 L⋅min(-1)⋅m(-2)), serum creatinine (1.21±0.43 mg/dL versus 1.26±0.57 mg/dL), and total bilirubin (1.34±3.45 mg/dL versus 1.06±1.84 mg/dL) were comparable between the two groups (p>0.05 for all comparisons). After transplantation, there were no significant differences in freedom from rejection or freedom from cardiac allograft vasculopathy. Posttransplant graft survival rates were similar between the HW-VAD group and the HMII-VAD group at 1, 2, and 3 years (88.4% versus 87.8%, 79.9% versus 83.8%, and 77.4% versus 79.9%, respectively; p=0.843)., Conclusions: These findings suggest similar hemodynamic unloading, pretransplant end-organ function, and posttransplant outcomes in patients bridged to transplantation with both the HW-VAD and HMII-VAD., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Hemolysis is becoming increasingly recognized as a major complication of left ventricular assist device (LVAD) support. Data regarding risk factors, prevalence, and outcomes are limited. To better define the characteristics and prognosis of hemolysis, we present a retrospective case-control study of LVAD patients in our institution., Methods: A detailed record review was conducted of 18 patients supported with the HeartMate II (HMII; Thoratec Corp, Pleasanton, CA) who were diagnosed with hemolysis, and their data were compared with 82 patients who received an LVAD implant during the same period who did not develop hemolysis. Patients were excluded if they did not survive hospitalization at the time of LVAD implantation. The primary end points of this analysis were time to death and time to first hospitalization., Results: Of 100 total patients, 18 HMII patients (18%) were diagnosed with hemolysis. Those with hemolysis were younger, had significantly higher lactate dehydrogenase and bilirubin levels, lower international normalized ratio, and no difference in cannula velocities by transthoracic echocardiography. Patient survival in the hemolysis group was markedly decreased at 1 year (38.9% vs 89.3%, p < 0.001), but no differences in hospitalization (p = 0.57) were observed. Partial to complete thrombosis was noted in all of the pumps at explant., Conclusions: These findings demonstrate that hemolysis is associated with high mortality, likely serving as a marker of pump thrombosis. Elevated lactate dehydrogenase and bilirubin levels are important indicators for hemolysis, and lower international normalized ratio may pre-dispose for this worrisome condition. Diagnosis should prompt clinicians to consider pump exchange or explant, listing for transplantation, or intensifying anti-coagulation., (Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Left ventricular assist devices (LVADs) have revolutionized the management of end-stage heart failure (ESHF). However, unexpectedly high rates of GI bleeding (GIB) have been described, and etiology and outcome remain unclear., Objective: To determine the prevalence, etiology, and outcome of GIB in LVAD recipients., Design: Retrospective case series., Setting: Tertiary care academic university hospital., Patients: 154 ESHF patients (55.4 years, 122 men/32 women) with LVADs implanted over a 10-year period., Main Outcome Measurements: Overt or occult GIB prompting endoscopic evaluation ≥ 7 days after LVAD implantation., Results: Over a mean of 0.9 ± 0.1 years of follow-up, 29 patients (19%) experienced 44 GIB episodes. Patients with GIB were older and received anticoagulation therapy before devices were implanted (P ≤ .02 for each). GIB was overt (n = 31) rather than occult (n = 13), and most patients presented with melena (n = 22, 50%); hemodynamic instability was observed in 13.6%. Each bleeding episode required 2.1 ± 0.1 diagnostic or therapeutic procedures, and a source was localized in 71%. Upper endoscopy provided the highest diagnostic yield; peptic bleeding (n = 14) and vascular malformations (n = 8) dominated the findings. Endoscopy was safe and well tolerated. Overall mortality was 35%, none directly from GIB., Limitation: Retrospective design., Conclusions: Rates of GIB with LVADs are higher than that seen in other patient populations, including those receiving anticoagulation and antiplatelet therapy. GIB episodes are mostly overt and predominantly from the upper GI tract. Endoscopy is safe in the LVAD population., (Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)