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Neutrophil to lymphocyte ratio (NLR) can predict mortality/complications in left ventricular assist device (LVAD) patients; however, the prognostic value of longitudinal NLR measurements has not been well studied. Here, we examine the mortality/complication incidence in patients with chronically increased NLR verses patients with acutely elevated NLR as a predictor of patient outcomes. This retrospective analysis included 102 patients who underwent LVAD implantation from 2016 to 2018 at a single center. The NLR was calculated at the time of surgery, and at 30 and 90 days after surgery. The NLR values were grouped into categorical data: low, normal (put in range), and high. Patients were classified in 2 groups based on change in their NLR values from surgery to 90 days; the H90 group had sustained increase of NLR over 90‐days and the N90 group had normalization of NLR at 90‐days. Actuarial survival the between study groups was measured using Kaplan–Meier curves. The N90 group had 50 patients (median age 58 (48–66) years, 21% female) at the time of LVAD placement. Group H90 had 52 patients (median age 64 (52–68) years, 16% female). Median age, body mass index (BMI), bilirubin, creatinine, and BNP at time of implant as well as type of device and implant strategy were comparable between the study groups. The post implant survival for N90 group was significantly better than the H90 group at 1 year (93% vs. 80%) and 2 years (90% vs. 67%) (log‐rank P =.001). Early post LVAD survival in patients with elevated NLR over 90 days postoperatively was significantly worse compared to patients who normalized the NLR at 90 days. [ABSTRACT FROM AUTHOR]

Objectives: Wide QRS duration and ventricular pacing are common in recipients of continuous-flow left ventricular assist devices (CF-LVADs) but their impact on outcomes remains unclear. We assessed the clinical and arrhythmic outcomes of CF-LVAD patients with wide QRS or right ventricular (RV) pacing at baseline, compared with those with narrow QRS and those with continued cardiac resynchronization therapy (CRT).Methods and Results: A total of 520 patients (57 ± 13 years) with an implantable cardioverter-defibrillator (ICD) (n = 240) or CRT-defibrillator (n = 280) who underwent CF-LVAD implantation at 5 centers in 2007-2015 were studied. Patients were divided into 3 groups: ICD-N (QRS ≤120 ms; n = 134), ICD-W (QRS >120 ms; n = 106), and CRT (n = 280). Mortality, hospitalization, and ventricular arrhythmia (VA) incidence were compared among the groups. Baseline QRS duration was different among the groups (100 ± 13 [ICD-N] vs 155 ± 26 [ICD-W] vs 159 ± 29 ms [CRT]; P < .0001). In the ICD-W group, 37 (35%) had >80% RV pacing at baseline. Median biventricular pacing in the CRT group was 96%. Over 523 days of CF-LVAD support, Kaplan-Meier analysis showed no difference in survival among groups (log rank P = .9). According to multivariate Cox regression, wide QRS duration and RV pacing were not associated with survival. QRS narrowed during CF-LVAD support in the ICD-W and CRT groups but was not associated with improved survival (P = .9). No differences were noted among the groups in hospitalizations (P = .9), VA (P = .2), or ICD shocks (P = .06).Conclusions: In this large CF-LVAD cohort, a wide QRS duration, high percentage of RV pacing at baseline, and changes in QRS duration after LVAD implantation were not associated with survival. Continued CRT after CF-LVAD implantation also was not associated with improved survival or HF hospitalizations. [ABSTRACT FROM AUTHOR]

Objective Left ventricular assist device (LVAD) surgery is complex, high risk, and expensive. The authors’ hypothesis is baseline regional cerebral oxygen saturation (rSO 2 ) might be a predictor of postoperative clinical outcomes. Design Retrospective review of 210 consecutive continuous flow LVAD patients between 2008 and 2014. The primary measure is 30-day mortality rate and secondary measures include modified major adverse cardiocerebral events (MACE), length of stay (LOS), and intensive care unit (ICU) stay. Multiple logistic regression models were applied to examine if a binary outcome variable, such as 30-day mortality and MACE, is associated with rSO 2 at baseline. Log-linear model was used to examine whether LOS or ICU stay hours is associated with rSO 2 at baseline. Setting Single institution, academic hospital. Participants Patients who received LVAD surgery ​at Jewish Hospital, Louisville, KY. Interventions All patients received LVAD surgery. Cerebral oximetry monitoring was used in both the preoperative and intraoperative periods. Measurements and Main Results The authors found that higher rSO 2 at baseline is associated with lower 30-day mortality with an odds ratio of 0.94 and 95% confidence interval (0.888, 0.995) for every 1% increase of rSO 2 . For secondary outcomes, baseline rSO 2 was not significantly associated with MACE, requirement for postoperative renal failure/dialysis, reoperation for bleeding, and LOS or ICU hours. Conclusions Regional cerebral oxygen saturation levels at baseline are significantly associated with 30-day mortality after LVAD surgeries. [ABSTRACT FROM AUTHOR]

The role of oxidative stress and leukocyte activation has not been elucidated in developing systemic inflammatory response syndrome ( SIRS) in heart failure ( HF) patients after continuous-flow left ventricular assist device ( CF-LVAD) implantation. The objective of this study was to investigate the change of plasma redox status and leukocyte activation in CF-LVAD implanted HF patients with or without SIRS. We recruited 31 CF-LVAD implanted HF patients (16 SIRS and 15 non- SIRS) and 11 healthy volunteers as the control. Pre- and postimplant blood samples were collected from the HF patients. Plasma levels of oxidized low-density lipoprotein ( oxLDL), malondialdehyde ( MDA), total antioxidant capacity ( TAC), superoxide dismutase ( SOD) in erythrocyte, myeloperoxidase ( MPO), and polymorphonuclear elastase ( PMN-elastase) were measured. The HF patients had a preexisting condition of oxidative stress than healthy controls as evident from the higher oxLDL and MDA levels as well as depleted SOD and TAC. Leukocyte activation in terms of higher plasma MPO and PMN-elastase was also prominent in HF patients than controls. Persistent oxidative stress and reduced antioxidant status were found to be more belligerent in HF patients with SIRS after the implantation of CF-LVAD when compared with non- SIRS patients. Similar to oxidative stress, the activation of blood leukocyte was significantly highlighted in SIRS patients after implantation compared with non- SIRS. We identified that the plasma redox status and leukocyte activation became more prominent in CF-LVAD implanted HF patients who developed SIRS. Our findings suggest that plasma biomarkers of oxidative stress and leukocyte activation may be associated with the development of SIRS after CF-LVAD implant surgery. [ABSTRACT FROM AUTHOR]

Heart failure is a clinical syndrome with significant morbidity and mortality. The use of left ventricular assist devices has improved outcomes for patients with advanced heart failure in the face of limited donor organs available for heart transplantation. This article describes current issues and limitations facing the left ventricular assist device field and explores how the field can be expanded in this setting. [ABSTRACT FROM AUTHOR]

Background Implantable cardioverter-defibrillators (ICDs) can improve survival in left ventricular assist device (LVAD) recipients. However, the impact of cardiac resynchronization therapy (CRT-D) on outcomes in continuous-flow left ventricular assist device (CF-LVAD) patients is not known. We sought to determine if CRT-D improved clinical outcomes in CF-LVAD patients compared with ICDs alone. Methods and Results Sixty-one consecutive CF-LVAD patients with an ICD or CRT-D were evaluated. Impacts of CRT-D on mortality, all-cause hospitalization, and incidence of atrial (AA) and ventricular (VA) arrhythmias after LVAD implantation was compared with patients with ICD alone. Of the 61 LVAD patients, 31 (age 59.8 ± 16 years, 84% male) had CRT-D and 30 (age 57.2 ± 13 years, 74% male) had ICD. Before LVAD implantation, no significant differences were noted between the groups in demographic and clinical characteristics, LVAD indications, and incidence of AA and VA. Over 682 ± 45 days of LVAD support, 8 patients (25.8%) died in the CRT-D arm versus 5 (16.7%) in the ICD arm ( P = .35). No differences were noted between the CRT-D and ICD groups in all-cause (96.8 vs 93.3%; P = .63) and HF (19.4 vs 26.7%; P = .78) hospitalizations, left ventricular (LV) end-diastolic diameter (6.4 ± 1.5 vs 6.2 ± 1.1 cm, P = .47), and incidence of AA (35.4% vs 33.3%; P = .80), VA (29% vs 26.6%; P = .86), and ICD shocks (22.6% vs 16.7%; P = .93). Beta-blocker and antiarrhythmic drug use after LVAD implantation was similar in both groups. Conclusions In patients with refractory HF who received CF-LVADs, CRT-D, compared with ICD, did not significantly improve mortality, all-cause hospitalization, LV dimensions, and incidence of AA and VA. [ABSTRACT FROM AUTHOR]

Background: The HeartWare left ventricular assist device (HVAD, HeartWare Inc, Framingham, MA) is the first implantable centrifugal continuous-flow pump approved for use as a bridge to transplantation. An infrequent but serious adverse event of LVAD support is thrombus ingestion or formation in the pump. In this study, we analyze the incidence of pump thrombus, evaluate the comparative effectiveness of various treatment strategies, and examine factors pre-disposing to the development of pump thrombus. Methods: The analysis included 382 patients who underwent implantation of the HVAD as part of the HeartWare Bridge to Transplant (BTT) and subsequent Continued Access Protocol (CAP) trial. Descriptive statistics and group comparisons were generated to analyze baseline characteristics, incidence of pump thrombus, and treatment outcomes. A multivariate analysis was performed to assess significant risk factors for developing pump thrombus. Results: There were 34 pump thrombus events observed in 31 patients (8.1% of the cohort) for a rate of 0.08 events per patient-year. The incidence of pump thrombus did not differ between BTT and CAP. Medical management of pump thrombus was attempted in 30 cases, and was successful in 15 (50%). A total of 16 patients underwent pump exchange, and 2 underwent urgent transplantation. Five patients with a pump thrombus died after medical therapy failed, 4 of whom also underwent a pump exchange. Survival at 1 year in patients with and without a pump thrombus was 69.4% and 85.5%, respectively (p = 0.21). A multivariable analysis revealed that significant risk factors for pump thrombus included a mean arterial pressure > 90 mm Hg, aspirin dose ≤ 81 mg, international normalized ratio ≤ 2, and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile level of ≥ 3 at implant. Conclusions: Pump thrombus is a clinically important adverse event in patients receiving an HVAD, occurring at a rate of 0.08 events per patient-year. Significant risk factors for pump thrombosis include elevated blood pressure and sub-optimal anti-coagulation and anti-platelet therapies. This suggests that pump thrombus event rates could be reduced through careful adherence to patient management guidelines. [Copyright &y& Elsevier]

Left ventricular assist devices (LVADs) are slowly gaining acceptance as the treatment of choice in appropriately selected patients with end-stage heart failure who are not transplant candidates. Obesity is a well-known risk factor for increased cardiovascular morbidity and mortality, and frequently can be the reason some patients are turned down for heart transplantation. Because of this experience in transplant patients, many centers have also been reluctant to offer these patients an LVAD for destination therapy (DT). Subsequently, the 1-year outcomes of obese patients receiving LVADs for DT at our center were reviewed. Fifty-eight consecutive patients (83% men) were implanted with HeartMate XVE ( n = 22) or HeartMate II ( n = 36) LVAD. Patients were divided into normal (body mass index [BMI] ≤ 30 kg/m2, n = 38) and obese (BMI ≥ 30 kg/m2, n = 20) groups according to their BMI. Preoperatively, there were statistically significant differences ( P < 0.05) between normal and obese groups in age (65.9 years vs. 54.7 years), weight (72.9 kg vs. 107.5 kg), BMI (24.1 kg/m2 vs. 35.2 kg/m2), and incidence of diabetes (37% vs. 60%). At 1-year follow-up, there were no statistically significant differences ( P > 0.5) between normal and obese groups: creatinine levels (1.4 vs. 1.5), New York Heart Association classification (1.2 vs. 1.6), and survival (63% vs. 65%). Our initial results demonstrate that morbidly obese patients with end-stage heart failure with a contraindication for transplant may successfully undergo implantation of an LVAD for DT. [ABSTRACT FROM AUTHOR]

The article discusses the United Network for Organ Sharing (UNOS) status code 1A, which is designated for candidates on the organ donor waiting list who have the highest priority on the basis of medical urgency. In the article the author reflects on the code's relevance in heart transplant patients who are supported with a Left Ventricular Assist Device.

Objectives: The aim of this study was to derive and validate a model to predict survival in candidates for HeartMate II (HMII) (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) support. Background: LVAD mortality risk prediction is important for candidate selection and communicating expectations to patients and clinicians. With the evolution of LVAD support, prior risk prediction models have become less valid. Methods: Patients enrolled into the HMII bridge to transplantation and destination therapy trials (N = 1,122) were randomly divided into derivation (DC) (n = 583) and validation cohorts (VC) (n = 539). Pre-operative candidate predictors of 90-day mortality were examined in the DC with logistic regression, from which the HMII Risk Score (HMRS) was derived. The HMRS was then applied to the VC. Results: There were 149 (13%) deaths within 90 days. In the DC, mortality (n = 80) was higher in older patients (odds ratio [OR]: 1.3, 95% confidence interval [CI]: 1.1 to 1.7 per 10 years), those with greater hypoalbuminemia (OR: 0.49, 95% CI: 0.31 to 0.76 per mg/dl of albumin), renal dysfunction (OR: 2.1, 95% CI: 1.4 to 3.2 per mg/dl creatinine), coagulopathy (OR: 3.1, 95% CI: 1.7 to 5.8 per international normalized ratio unit), and in those receiving LVAD support at less experienced centers (OR: 2.2, 95% CI: 1.2 to 4.4 for <15 trial patients). Mortality in the DC low, medium, and high HMRS groups was 4%, 16%, and 29%, respectively (p < 0.001). In the VC, corresponding mortality was 8%, 11%, and 25%, respectively (p < 0.001). HMRS discrimination was good (area under the receiver-operating characteristic curve: 0.71, 95% CI: 0.66 to 0.75). Conclusions: The HMRS might be useful for mortality risk stratification in HMII candidates and may serve as an additional tool in the patient selection process. [ABSTRACT FROM AUTHOR]

Background: Patterns of weight change after implantation of a continuous-flow left ventricular assist device (CF-LVAD) can affect transplant candidacy and may influence outcomes. We evaluated changes in weight over a 24-month period from a national LVAD clinical trial database. Methods: A retrospective analysis was performed of 896 patients enrolled into the HeartMate II Clinical trials for bridge-to-transplant and destination therapy from March 2005 to January 2009. The patients were divided into 4 groups: underweight (body mass index [BMI] <18.5 [kg/m2]); normal (BMI 18.5 to 29.9); obese (BMI 30 to 34.9); and extremely obese (BMI≥35). Baseline BMI was compared with BMI at 6 months and 24 months after implant. BMI change >10% of baseline was considered clinically significant. Results: At 6 months, underweight and normal-weight patients had significant increases in BMI, with effects sustained up to 24 months (p < 0.01). Underweight patients gained weight most often, with 75% showing clinically meaningful weight gain at 24 months. Obese and extremely obese patients, in contrast, did not experience weight change over the same period. Pre-albumin levels improved from baseline to 6 months in all patients. Conclusions: Underweight and normal-weight patients had an increase in BMI after LVAD implantation, and these changes persisted through 24 months. The BMIs of obese and extremely obese patients remained unchanged. Nutritional status improved in all groups. [ABSTRACT FROM AUTHOR]

Background: Extremes of body mass index (BMI) are often considered contraindications to use of a left ventricular assist device (LVAD), but data regarding outcomes across the spectrum of BMI are limited. We sought to assess the association of BMI with survival and major morbidity after continuous-flow (CF) LVAD implantation. Methods: Patients (n = 896) enrolled in the HeartMate II LVAD bridge-to-transplantation and destination therapy trials were divided into 4 BMI groups: underweight (<18.5 kg/m2); normal (18.5 kg/m2 ≤ BMI < 30 kg/m2); obese (30 kg/m2 ≤ BMI < 35 kg/m2); and extremely obese (≥35 kg/m2). The association of BMI with survival was tested using Kaplan–Meier analysis and proportional hazards regression. Major adverse events were compared using Poisson''s regression and chi-square tests. Results: At implantation, 48 (5%) patients were underweight, 596 (67%) normal weight, 164 (18%) obese and 88 (10%) extremely obese. BMI extremes were associated with differences in creatinine, albumin, age, central venous pressure and etiology. BMI was not associated with survival in the univariate analysis (p = 0.83) or in adjusted models (extremely obese: hazard ratio [HR] 1.29, p = 0.231; obese: HR 0.94, p = 0.723; underweight: HR 1.23, p = 0.452). Underweight patients were more likely to have bleeding events (p < 0.001), whereas extremely obese patients had higher rates of device-related infection (p = 0.041) and rehospitalization (p = 0.014). Conclusions: Overall survival in patients receiving CF LVAD is similar across BMI categories. Carefully selected patients at both extremes of BMI have good mid-term survival after LVAD and should be considered for LVAD implantation relative to overall risk profile. [ABSTRACT FROM AUTHOR]

Background: The HeartMate II (Thoratec Corp, Pleasanton, CA) continuous-flow left ventricular assist device (LVAD) improved survival in destination therapy (DT) patients during a randomized trial compared with pulsatile-flow LVADs. This study documented changes in cognitive performance in DT patients from that trial to determine if there were differences between continuous-flow and pulsatile-flow support. Methods: Data were collected in a sub-study from 96 HeartMate II continuous-flow and 30 HeartMate XVE pulsatile-flow LVAD patients from 12 of the 35 trial sites that followed the same serial neurocognitive (NC) testing protocol at 1, 3, 6, 12, and 24 months after LVAD implantation. Spatial perception, memory, language, executive functions, and processing speed were the domains assessed with 10 standard cognitive measures. Differences over time and between LVAD type were evaluated with linear mixed-effects modeling. Results: From 1 to 24 months after LVAD implantation, changes in NC functions were stable or showed improvement in all domains, and there were no differences between the continuous-flow and pulsatile-flow groups. Data at 24 months were only available from patients with the continuous-flow LVAD due to the limited durability of the HeartMate XVE device. There was no decline in any NC domain over the time of LVAD support. Missing data not collected from patients who died could have resulted in a bias toward inflated study results. Conclusions: The NC performance of advanced heart failure patients supported with continuous-flow and pulsatile-flow LVADs shows stabilization or improvement during support for up to 24 months. [Copyright &y& Elsevier]