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Background The enterosalivary nitrate-nitrite-nitric oxide (NO3-NO2-NO) pathway generates NO following oral microbiota-mediated production of salivary nitrite, potentially linking the oral microbiota to reduced cardiometabolic risk. Nitrite depletion by oral bacteria may also be important for determining the net nitrite available systemically. We examine if higher abundance of oral microbial genes favoring increased oral nitrite generation and decreased nitrite depletion is associated with a better cardiometabolic profile cross-sectionally. Methods and Results This study includes 764 adults (mean [SD] age 32 [9] years, 71% women) enrolled in ORIGINS (Oral Infections, Glucose Intolerance, and Insulin Resistance Study). Microbial DNA from subgingival dental plaques underwent 16S rRNA gene sequencing; PICRUSt2 was used to estimate functional gene profiles. To represent the different components and pathways of nitrogen metabolism in bacteria, predicted gene abundances were operationalized to create summary scores by (1) bacterial nitrogen metabolic pathway or (2) biochemical product (NO2, NO, or ammonia [NH3]) formed by the action of the bacterial reductases encoded. Finally, nitrite generation-to-depletion ratios of gene abundances were created from the above summary scores. A composite cardiometabolic Z score was created from cardiometabolic risk variables, with higher scores associated with worse cardiometabolic health. We performed multivariable linear regression analysis with cardiometabolic Z score as the outcome and the gene abundance summary scores and ratios as predictor variables, adjusting for sex, age, race, and ethnicity in the simple adjusted model. A 1 SD higher NO versus NH3 summary ratio was inversely associated with a -0.10 (false discovery rate q=0.003) lower composite cardiometabolic Z score in simple adjusted models. Higher NH3 summary score (suggestive of nitrite depletion) was associated with higher cardiometabolic risk, with a 0.06 (false discovery rate q=0.04) higher composite cardiometabolic Z score. Conclusions Increased net capacity for nitrite generation versus depletion by oral bacteria, assessed through a metagenome estimation approach, is associated with lower levels of cardiometabolic risk.

Periodontitis affects up to 50% of individuals worldwide, and 8.5% are diagnosed with diabetes. The high-comorbidity rate of these diseases may suggest, at least in part, a shared etiology and pathophysiology. Changes in oral microbial communities have been documented in the context of severe periodontitis and diabetes, both independently and together. However, much less is known about the early oral microbial markers of these diseases. We used a subset of the ORIGINS project dataset, which collected detailed periodontal and cardiometabolic information from 787 healthy individuals, to identify early microbial markers of periodontitis and its association with markers of cardiometabolic health. Using state-of-the-art compositional data analysis tools, we identified the log-ratio of Treponema to Corynebacterium bacteria to be a novel Microbial Indicator of Periodontitis (MIP), and found that this MIP correlates with poor periodontal health and cardiometabolic markers early in disease pathogenesis in both subgingival plaque and saliva.

‘BRS Isis' is a new colored seedless table grape tolerant to downy mildew, the main vine disease in subtropical humid areas. This new seedless cultivar is an interspecific hybrid from the crossing of CNPUV 681–29 [Arkansas 1976 X CNPUV 147–3 (‘Niagara Branca' x ‘Venus')] x ‘BRS Linda', and was recently released by Embrapa Grape and Wine, Brazil. The performance of ‘BRS Isis' seedless grape was evaluated in an experimental vineyard in 2016 located in a subtropical area at Marialva city, state of Parana, Brazil. The vines were grafted onto ‘IAC 766 Campinas' rootstock and trained in an overhead trellising system spaced at 2× 5 m. Vines were cane-pruning in late winter of July 2016, and for assessments, 20 representative vines were selected in the area. As ‘BRS Isis' is a very fruitful grape, presenting 4 bunches per shoot, a load adjustment was performed after fruitset removing 50% of bunches per shoot, leaving 2 bunches per shoot, equivalent to a density of 10 bunches.m−2. The duration in days of the main phenological stages from pruning to harvest, and the physicochemical and yield characteristics of ‘BRS Isis' seedless grape were subjected to evaluation. It was determined that the cycle is 144 days. The means of berry and bunch weight was 6.7 ± 1.0 g and 500.0 ± 0.04 g, respectively, and the color index of berries (CIRG) was 4.3 ± 1.3. The means of total soluble solids (TSS), titratable acidity (TA) and maturity index (TSS/TA) observed were 14.2 ± 0.3° Brix, 0.6 ± 0.04% of tartaric acid and 24.1 ± 1.5, respectively, while the yield was 49.0 ± 5.7 tons.ha−1. The yield observed is considered high to keep a sustainable crop over time, thus, in order to obtain grapes of ‘BRS Isis' with regular yield, and possibly, with a higher content of soluble solids, it is desirable to keep only 1 bunch per shoot (5 bunches.m−2) after fruitset.

De novo aortic insufficiency (AI) is a common adverse event after continuous-flow left ventricular assist device (LVAD) placement and is associated with morbidity and mortality. This study aims to compare the development of de novo AI between HeartMate 3 (Abbott) and HeartMate II LVAD recipients. A retrospective review was conducted of clinical characteristics and serial echocardiograms (1 month, 6 months, and 1 year postimplantation) of HeartMate 3 patients implanted between November 2014 and March 2019 and of HeartMate II patients implanted between April 2004 and December 2015 at Columbia University Irving Medical Center. One hundred twenty-two patients were excluded from analysis for a history of aortic valve surgery, concomitant aortic valve surgery with LVAD implant, or more than trace preoperative AI left untreated. De novo AI was defined as development of more than mild AI after LVAD implant. Included in the study were 121 HeartMate 3 patients and 270 HeartMate II patients. After accounting for competing risks of death and transplantation, there was no significant difference in the development of de novo AI by 1 year postimplantation between HeartMate II and HeartMate 3 patients (P =.68). There was no significant difference in severity of AI developed up to 1 year post-implantation between HeartMate II and HeartMate 3 patients. Development of de novo AI is comparable between HeartMate 3 and HeartMate II patients. There is no significant difference in severity of AI between HeartMate II and HeartMate 3 patients. [ABSTRACT FROM AUTHOR]

Trimethylamine N-oxide (TMAO)—a gut-derived metabolite—is elevated in heart failure (HF) and linked to poor prognosis. We investigated variations in TMAO in HF, left ventricular assist device (LVAD), and heart transplant (HT) and assessed its relation with inflammation, endotoxemia, oxidative stress, and gut dysbiosis. METHODS: We enrolled 341 patients. TMAO, CRP (C-reactive protein), IL (interleukin)-6, TNF-α (tumor necrosis factor alpha), ET-1 (endothelin-1), adiponectin, lipopolysaccharide, soluble CD14, and isoprostane were measured in 611 blood samples in HF (New York Heart Association class I–IV) and at multiple time points post-LVAD and post-HT. Gut microbiota were assessed via 16S rRNA sequencing among 327 stool samples. Multivariable regression models were used to assess the relationship between TMAO and (1) New York Heart Association class; (2) pre- versus post-LVAD or post-HT; (3) biomarkers of inflammation, endotoxemia, oxidative stress, and microbial diversity. RESULTS: ln-TMAO was lower among HF New York Heart Association class I (1.23 [95% CI, 0.52–1.94] µM) versus either class II, III, or IV (1.99 [95% CI, 1.68–2.30], 1.97 [95% CI, 1.71–2.24], and 2.09 [95% CI, 1.83–2.34] µM, respectively; all P<0.05). In comparison to class II–IV, ln-TMAO was lower 1 month post-LVAD (1.58 [95% CI, 1.32–1.83] µM) and 1 week and 1 month post-HT (0.97 [95% CI, 0.60–1.35] and 1.36 [95% CI, 1.01–1.70] µM). ln-TMAO levels in long-term LVAD (>6 months: 1.99 [95% CI, 1.76–2.22] µM) and HT (>6 months: 1.86 [95% CI, 1.66–2.05] µM) were not different from symptomatic HF. After multivariable adjustments, TMAO was not associated with biomarkers of inflammation, endotoxemia, oxidative stress, or microbial diversity. CONCLUSIONS: TMAO levels are increased in symptomatic HF patients and remain elevated long term after LVAD and HT. TMAO levels were independent from measures of inflammation, endotoxemia, oxidative stress, and gut dysbiosis. [ABSTRACT FROM AUTHOR]

Vasoplegia is a frequent complication of left ventricular assist device (LVAD) implantation. We investigated the effectiveness of methylene blue (MB) for vasoplegia in LVAD recipients. Twenty-seven patients received MB for vasoplegia after LVAD implantation and met study criteria between March 2015 and May 2018. Propensity score inverse probability weighting identified 41 controls who did not receive MB for post-LVAD vasoplegia. Clinical outcomes were compared between control and MB groups and between patients who received doses during (n = 15) and after surgery (n = 12). Hemodynamics and vasopressor requirements were analyzed using analysis of covariance. Median total MB dose was 1.9 mg/kg (interquartile range, 1.2-2.2 mg/kg). Methylene blue recipients experienced a transient initial decline in norepinephrine requirement from 141 ng/kg per min (95% confidence interval [CI], 81-201 ng/kg per min) to 117 ng/kg per min (95% CI, 58-176 ng/kg per min; P =.022) and a delayed decline in vasopressin from 4.8 U/h (95% CI, 3.8-5.8 U/h) to 4.0 U/h (95% CI, 2.8-5.1 U/h) (P =.004). In-hospital mortality, postoperative complications, and end-organ dysfunction did not differ from those of controls. There were no observed differences in mean arterial pressure, vasopressor requirements, or outcomes between patients who received doses during or after surgery. Weighted overall mortality in the entire study cohort was 8.8%. Although MB may affect vasopressor requirements, clinical outcomes in vasoplegia after LVAD implantation did not improve and were not affected by the timing of administration. [ABSTRACT FROM AUTHOR]

Although extremely high pulmonary vascular resistance (PVR) is a relative contraindication for heart transplantation (HTx), recent data with continuous-flow left ventricular assist devices (LVADs) indicate HTx outcomes may be different when high PVR is managed with an LVAD. This study clarifies the contemporary association between PVR at HTx and posttransplant survival in LVAD vs non-LVAD cohorts. We reviewed the United Network for Organ Sharing registry for adults who received a transplant from 2008 to 2015. In those with continuous-flow LVADs and those with no VADs at HTx, (non-VAD), we grouped patients by low PVR (PVR <3), intermediate PVR (PVR 3 to <6), and high PVR (PVR ≥6) groups. Adjusted hazard ratios (aHRs) for death after HTx were calculated by Cox regression. The non-LVAD cohort included 6270 patients (4385 in low, 1643 in intermediate, and 242 in high PVR), and the LVAD cohort included 4111 patients (3227 in low, 798 in intermediate, and 86 in high PVR). The high PVR LVAD group had the worst survival, which was not significant, likely to low power (P =.300). The aHR for death in non-LVAD was 1.047 (95% confidence interval, 1.010-1.088) and in LVAD was 1.063 (95% confidence interval, 1.010-1.119). Cubic spline analysis demonstrated nonlinear associations between PVR and the aHR, especially in the LVAD cohort. There was no significant evidence to conclude the effect of pretransplant PVR on posttransplant survival is higher in LVAD vs non-LVAD patients, based on analysis of the United Network for Organ Sharing database. However, further investigations are indicated to clarify HTx candidacy in those with extremely high PVR even after LVAD. [ABSTRACT FROM AUTHOR]

The use of short-term mechanical circulatory support (ST-MCS) has increased for refractory cardiogenic shock. However, there are scant data about bridge-to-recovery patients. We retrospectively reviewed 502 patients with cardiogenic shock who received venoarterial extracorporeal membrane oxygenation or a temporary surgical ventricular assist device as ST-MCS between 2010 and 2016. There were 178 patients (35.5%) who survived through device explantation. Of these, 149 patients (29.7%) survived to discharge and were included for analysis. The primary outcome was midterm survival without undergoing heart replacement therapy. In our bridge-to-recovery cohort, 101 patients (67.8%) were men, and the median age was 59 years (interquartile range, 51 to 67 years). Etiology of cardiogenic shock included postcardiotomy shock in 35.6% of patients (n = 53), allograft failure in 26.8% (n = 40), acute myocardial infarction (AMI) in 24.2% (n = 36), and other acute decompensated heart failure in 14.4% (n = 20). There were 24 major events (16.1%) recorded, including 21 patients who died and 3 patients who received heart replacement therapy during median follow-up of 306 days (interquartile range, 58.25 to 916.75 days). Overall freedom from event at 3 years was 74.2%. In subgroup analysis, AMI patients had a significantly worse freedom-from-event rate at 40.4% (p < 0.001). By univariate Cox analysis, AMI etiology (p = 0.003), length of ST-MCS (p = 0.06), blood urea nitrogen (p = 0.012), and left ventricular ejection fraction (p = 0.005) at discharge were predictors for adverse events. The overall midterm outcome of patients explanted from ST-MCS is favorable except for AMI patients. [ABSTRACT FROM AUTHOR]

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Background Blood type O heart transplant recipients wait longer than non-O recipients and frequently require bridging left ventricular assist devices (LVADs). However, rarely has the effect of this disparity been shown in a large registry. This study used Markov simulation to clarify the outcome difference between O and non-O candidates and how allocation change could affect survival. Methods We reviewed the United Network for Organ Sharing registry for adults listed for heart transplantation from 2008 to 2015. Cumulative incidences of death or transplant and survival after listing were compared between O and non-O using propensity matching. A four-state Markov model—waiting without LVAD, waiting with LVAD, transplantation, and death—was created to simulate survival after listing. Sensitivity analysis was performed to see how the percentage of O hearts in non-O recipients would affect survivals. Results A total of 8,187 O and non-O candidates were included after matching. The cumulative incidence of transplantation was lower in O (p < 0.001), and death after listing was significantly higher (p < 0.001). During a median follow-up of 2.1 years, 69.6% of non-O candidates were transplanted, compared with 54.9% of O candidates (p < 0.001). Despite this disparity, 19% of non-O recipients received O hearts. Our simulated survival demonstrated that decreasing the O heart percentage in non-O recipients from the current 19% to 5% would provide similar survival in O and non-O after listing. Conclusions Under the current strategy, there are death and transplant rate differences between O and non-O candidates. Our simulation-based allocation strategy might aid in mitigating this discrepancy across blood types. [ABSTRACT FROM AUTHOR]

BACKGROUND: Continuous-flow left ventricular assist devices (CF-LVADs) have become a standard treatment choice in advanced heart failure patients. We hypothesized that practice patterns with regards to CF-LVAD utilization vary significantly among transplant centers and impact waitlist outcomes. METHODS AND RESULTS: The United Network for Organ Sharing registry was queried to identify adult patients who were waitlisted for heart transplantation (HT) between 2008 and 2015. Each patient was assigned a propensity score based on likelihood of receiving a durable CF-LVAD before or while waitlisted. The primary outcomes of interest were death or delisting for worsening status and HT at 1 year. A total of 22 863 patients from 92 centers were identified. Among these, 9013 (39.4%) were mechanically supported. CF-LVAD utilization varied significantly between and within United Network for Organ Sharing regions. Freedom from waitlist death or delisting was significantly lower in propensity-score--matched patients who were mechanically supported versus medically managed (83.5% versus 79.2%; P<0.001). However, cumulative incidence of HT was also lower in mechanically supported patients (53.3% versus 63.6%; P<0.001). Congruous mechanical and medical bridging strategies based on clinical risk profile were associated with lower risk of death or delisting (hazard ratio, 0.88; P=0.027) and higher likelihood of HT (hazard ratio, 1.14; P<0.001). CONCLUSIONS: CF-LVAD utilization may lower waitlist mortality at the expense of lower likelihood of HT. Decision to use CF-LVAD and timing of transition should be individualized based on patient-, center-, and regionlevel risk factors to achieve optimal outcomes. [ABSTRACT FROM AUTHOR]

Background Hospital readmissions have an adverse effect on the quality of life in patients with end-stage heart failure. We examined the temporal pattern, predictors, and outcomes of readmission in continuous flow left ventricular assist device–supported patients. Methods We retrospectively reviewed inpatient data of 350 consecutive patients who received a continuous-flow left ventricular assist device at our center between May 2004 and December 2014. A total time–restricted model was used to estimate hazard ratios for readmission, and the Nelson nonparametric method was used to estimate mean cumulative function for each cause of readmission. Results The mean age was 57 ± 13 years, 82.6% received a HeartMate II (Abbott Laboratories, Chicago, IL), and 26.3% were destination therapy. The 30-day readmission rate was 21.7%, and 264 readmissions (41.1%) occurred within the first 6 months of support. The leading cause of readmission was bleeding (0.74 mean cumulative events per person), followed by infection (0.7), device failure (0.52), arrhythmia (0.3), and right heart failure (0.28) at 3 years. The number of readmissions did not have an adverse effect on survival (hazard ratio, 1.03; 95% confidence interval, 0.92 to 1.17; p = 0.58). Increase in each body mass index unit was associated with 1.029 times the rate of overall readmission ( p = 0.041). Patients with a body mass index of 30 kg/m 2 or higher had increased readmissions for device failure ( p = 0.008) and right heart failure ( p = 0.03). Conclusions Readmission burden is highest during the first few months of continuous-flow left ventricular assist device support, but survival is not affected. Patients with an elevated body mass index are at increased risk for readmissions for device failure and right heart failure. [ABSTRACT FROM AUTHOR]

BACKGROUND: There is mixed evidence of racial and socioeconomic disparities in heart transplant outcomes. Their underlying cause--and whether individual- or community-level traits are most influential--remains unclear. The current study aimed to characterize socioeconomic disparities in outcomes and identify time trends and mediators of these disparities. METHODS AND RESULTS: We used United Network for Organ Sharing registry data and included 33 893 adult heart transplant recipients between 1994 and 2014. Socioeconomic status (SES) indicators included insurance, education, and neighborhood SES measured using a composite index. Black race and multiple indicators of low SES were associated with the primary outcome of death or retransplant, independent of baseline clinical characteristics. Blacks had lower HLA and race matching, but further adjustment for these and other graft characteristics only slightly attenuated the association with black race (HR, 1.25 after adjustment). This and the associations with neighborhood SES (HR, 1.19 for lowest versus highest decile), Medicare (HR, 1.17), Medicaid (HR, 1.29), and college education (HR, 0.90) remained significant after full adjustment. When comparing early (1994-2000) and late (2001-2014) cohorts, the disparities associated with the middle (second and third) quartiles significantly decreased over time, but those associated with lowest SES quartile and black race persisted. Low neighborhood SES was also associated with higher risks of noncompliance (HR, 1.76), rejection (HR, 1.28), hospitalization (HR, 1.13), and infection (HR, 1.10). CONCLUSIONS: Racial and socioeconomic disparities exist in heart transplant outcomes, but the latter may be narrowing over time. These disparities are not explained by differences in clinical or graft characteristics. [ABSTRACT FROM AUTHOR]

BACKGROUND: Patients with restrictive cardiomyopathy (RCM) and hypertrophic cardiomyopathy (HCM) generally are considered poor candidates for mechanical circulatory support devices (MCSDs) and often not able to be bridged mechanically to heart transplantation. This study characterized MCSD utilization and transplant waitlist outcomes in patients with RCM/HCM under the current allocation system and discusses changes in the era of the new donor allocation system. METHODS AND RESULTS: Patients waitlisted from 2006 to 2016 in the United Network for Organ Sharing registry were stratified by RCM/ HCM versus other diagnoses. MCSD utilization and waitlist duration were analyzed by propensity score models. Waitlist outcomes were assessed by cumulative incidence functions with competing events. Predictors of waitlist mortality or delisting for worsening status in patients with RCM/ HCM were identified by proportional hazards model. Of 30 608 patients on the waitlist, 5.1% had RCM/HCM. Patients with RCM/HCM had 31 fewer waitlist days (P<0.01) and were ≈26% less likely to receive MCSD (P<0.01). Cumulative incidence of waitlist mortality was similar between cohorts; however, patients with RCM/HCM had higher incidence of heart transplantation. Predictors of waitlist mortality or delisting for worsening status in patients with RCM/HCM without MCSD support included estimated glomerular filtration rate <60 mL/min per 1.73 m², pulmonary capillary wedge pressure >20 mm Hg, inotrope use, and subjective frailty. CONCLUSIONS: Patients with RCM/HCM are less likely to receive MCSD but have similar waitlist mortality and slightly higher incidence of transplantation compared with other patients. The United Network for Organ Sharing RCM/HCM risk model can help identify patients who are at high risk for clinical deterioration and in need of expedited heart transplantation. [ABSTRACT FROM AUTHOR]

Objective Venous-arterial extracorporeal membrane oxygenation (VA-ECMO) is a well-established therapy for refractory cardiopulmonary failure. Femoral cannulation offers a quick and effective means of providing circulatory support but is not without complication. Inflammation or lymphatic disruption at the site of cannulation can cause the formation of lymphoceles, leading to the patient's discomfort and possibly necessitating intervention. The purpose of this study was to evaluate the incidence of in-hospital lymphocele formation in VA-ECMO patients and to identify predictors for their development. Methods We conducted a single-center retrospective review of 192 patients who underwent femoral VA-ECMO insertion and subsequent decannulation from March 2007 to August 2016 for cardiogenic shock. Baseline demographics, risk factors, and cannulation strategies were examined. Groin lymphocele formation was assessed as the primary outcome. Results Median age was 58 years (interquartile range, 48-67 years) with a median duration of support of 4 days (interquartile range, 2-6 days). Lymphocele formation was identified in 31 patients (16%). Patients who developed lymphoceles were more likely to have post-heart transplantation primary graft dysfunction (PGD) as an indication for ECMO support compared with those who did not (54.2% vs 8%; P < .001). ECMO duration was similar between groups, but lymphocele patients were more likely to have undergone femoral cutdown procedures (68% vs 42%; P = .010). Compared with those PGD patients who did not develop lymphoceles, PGD lymphocele patients had higher rates of diabetes mellitus preoperatively (62% vs 8%; P = .006). Thirteen (42%) patients required surgical incision and drainage, and 4 of these patients (31%) required repeated surgical intervention. Conclusions Lymphocele formation is relatively common after femoral VA-ECMO. There was a significantly higher incidence of lymphocele formation in diabetic patients requiring support for PGD after heart transplantation. [ABSTRACT FROM AUTHOR]

Background Optimal anticoagulation strategy remains uncertain in patients with heparin-induced thrombocytopenia (HIT) and undergoing left ventricular assist device (LVAD) implantation. We describe our protocol of abciximab and heparin in these patients. Methods Our protocol is to administer abciximab, 0.25 mg/kg loading dose, followed by continuous infusion of 0.125 μg · kg −1 · min −1 throughout cardiopulmonary bypass. Full-dose heparin is then given with subsequent additional doses to maintain an activated clotting time of 400 seconds or longer. The abciximab infusion is stopped 15 minutes after heparin reversal with protamine, and platelets are transfused. Results Six patients underwent LVAD implantation with this protocol in our program. HIT was confirmed in 4 patients was suspected in 2, which was negative after the operation. One patient received a HeartMate XVE (Thoratec Corp, Pleasanton, CA) and the others received HeartMate II (Thoratec Corp). There were no thromboembolic complications. One patient required chest reexploration for bleeding and temporary right VAD support. Postoperative anticoagulation with argatroban was restarted on median postoperative day 3 (range, days 1 to 6) and warfarin was started on day 5 (range, days 3 to 12). Median postoperative intensive care unit stay was 9 days (range, 5 to 76 days), and hospital stay was 22 days (range, 18 to 132 days). After the initial LVAD implantation, 1 patient required HeartMate XVE LVAD exchange to HeartMate II and subsequent heart transplant, both of which were performed with the abciximab/heparin protocol. A HeartMate II device was explanted in another patient after myocardial recovery. The remaining 4 patients are alive on device support. Conclusions This is the first report of a novel abciximab/heparin protocol for LVAD implantation in patients with HIT. The preliminary results suggest the feasibility and safety of this protocol. [ABSTRACT FROM AUTHOR]

BACKGROUND: Gastrointestinal (GI) bleeding is one of the most common complications after continuous-flow left ventricular assist device implantation. More than one third of patients with incident bleed go on to develop recurrent GI bleeding. Octreotide, a somatostatin analog, is proposed to reduce the risk of recurrent GI bleeding in this population. METHODS AND RESULTS: This multicenter, retrospective analysis evaluated 51 continuous-flow left ventricular assist device patients who received secondary prophylaxis with octreotide after their index GI bleed from 2009 to 2015. All patients had a hospitalization for GI bleed and received octreotide after discharge. Patient demographics, medical and medication history, and clinical characteristics of patients who rebled after receiving octreotide were compared with non-rebleeders. These data were also compared with matched historical control patients previously enrolled in the HMII (HeartMate II) clinical trials, none of whom received octreotide, to provide a context for the bleeding rates. Twelve patients (24%) who received secondary octreotide prophylaxis developed another GI bleed, whereas 39 (76%) did not. There were similar intergroup demographics; however, significantly more bleeders had a previous GI bleeding history before left ventricular assist device placement (33% versus 5%; P=0.02) and greater frequency of angiodysplasia confirmed during endoscopy (58% versus 23%; P=0.03). Fewer patients in this study experienced a recurrent GI bleed compared with a matched historical control group that did not receive octreotide (24% versus 43%; P=0.04). CONCLUSIONS: Patients with continuous-flow left ventricular assist device receiving secondary prophylaxis with octreotide had a significantly lower GI bleed recurrence compared with historical controls not treated with octreotide. Additional prospective studies are needed to confirm these data. [ABSTRACT FROM AUTHOR]

Background Few studies have evaluated the long-term effects of continuous blood flow with reduced pulsatility on end-organ function. Methods Between May 2004 and December 2015, 469 patients underwent continuous-flow left ventricular assist device (LVAD) implantation at our center. Our study included 59 (13%) patients who were supported with an LVAD for a minimum of 3 years. We evaluated postoperative renal function and hepatic function at 1 and 6 months, and 1, 2, and 3 years after implantation in those 59 patients. Results The patients’ mean age was 63 ± 13 years, 81% were male, 53% had an ischemic cause of heart failure, and 68% underwent LVAD implantation as destination therapy. All laboratory determinations showed significant improvements at 1 month after the procedure. Hepatic values remained in a normal range for up to 3 years, although renal function improvement was predominantly transient. One month after implantation, the mean estimated glomerular filtration rate (eGFR) was improved from 58.2 ± 27.9 to 77.7 ± 33.5 mL/min/1.73 m 2 . However, 46 (78%) patients showed a gradual decline in eGFR to only 1.7% above the preoperative value after 3 years ( p = 0.67 vs baseline). The risk factors for impaired renal function after long-term support were age 60 years or older, ischemic cause, and late right heart failure. Conclusions Continuous-flow LVAD improves renal and hepatic functions in patients with advanced heart failure. However, in most, the initial improvement in renal function is largely transient and returns to baseline after a prolonged support period. [ABSTRACT FROM AUTHOR]

Background—Low socioeconomic status (SES) is a known risk factor for heart failure, mortality among those with heart failure, and poor post heart transplant (HT) outcomes. This study sought to determine whether SES is associated with decreased waitlist survival while on left ventricular assist device (LVADs) support and after HT. Methods and Results—A total of 3361 adult patients bridged to primary HT with an LVAD between May 2004 and April 2014 were identified in the UNOS database (United Network for Organ Sharing). SES was measured using the Agency for Healthcare Research and Quality SES index using data from the 2014 American Community Survey. In the study cohort, SES did not have an association with the combined end point of death or delisting on LVAD support (P=0.30). In a cause-specific unadjusted model, those in the top (hazard ratio, 1.55; 95% confidence interval, 1.14–2.11; P=0.005) and second greatest SES quartile (hazard ratio 1.50; 95% confidence interval, 1.10–2.04; P=0.01) had an increased risk of death on device support compared with the lowest SES quartile. Adjusting for clinical risk factors mitigated the increased risk. There was no association between SES and complications. Post-HT survival, both crude and adjusted, was decreased for patients in the lowest quartile of SES index compared with all other SES quartiles. Conclusions—Freedom from waitlist death or delisting was not affected by SES. Patients with a higher SES had an increased unadjusted risk of waitlist mortality during LVAD support, which was mitigated by adjusting for increased comorbid conditions. Low SES was associated with worse post-HT outcomes. Further study is needed to confirm and understand a differential effect of SES on post-transplant outcomes that was not seen during LVAD support before HT. [ABSTRACT FROM AUTHOR]

Background--Advanced systolic heart failure is associated with myocardial and systemic metabolic abnormalities, including low levels of total cholesterol and low-density lipoprotein. Low cholesterol and low-density lipoprotein have been associated with greater mortality in heart failure. Implantation of a left ventricular assist device (LVAD) reverses some of the metabolic derangements of advanced heart failure. Methods and Results--A cohort was retrospectively assembled from 2 high-volume implantation centers, totaling 295 continuous-flow LVAD recipients with ≥2 cholesterol values available. The cohort was predominantly bridge-totransplantation (67%), with median age of 59 years and 49% ischemic heart failure cause. Total cholesterol, low-density lipoprotein, high-density lipoprotein, and triglyceride levels all significantly increased after LVAD implantation (median values from implantation to 3 months post implantation 125-150 mg/dL, 67-85 mg/dL, 32-42 mg/dL, and 97-126 mg/ dL, respectively). On Cox proportional hazards modeling, patients achieving recovery of total cholesterol levels, defined as a median or greater change from pre implantation to 3 months post-LVAD implantation, had significantly better unadjusted survival (hazard ratio, 0.445; 95% confidence interval, 0.212-0.932) and adjusted survival (hazard ratio, 0.241; 95% confidence interval, 0.092-0.628) than those without cholesterol recovery after LVAD implantation. The continuous variable of total cholesterol at 3 months post implantation and the cholesterol increase from pre implantation to 3 months were also both significantly associated with survival during LVAD support. Conclusions--Initiation of continuous-flow LVAD support was associated with significant recovery of all 4 lipid variables. Patients with a greater increase in total cholesterol by 3 months post implantation had superior survival during LVAD support. [ABSTRACT FROM AUTHOR]

Background--Time course and predictors of myocardial recovery on contemporary left ventricular assist device support are poorly defined because of limited number of recovery patients at any implanting center. This study sought to investigate myocardial recovery using multicenter data from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Methods and Results--Thirteen thousand four hundred fifty-four adult patients were studied. Device explant rates for myocardial recovery were 0.9% at 1-year, 1.9% at 2-year, and 3.1% at 3-year follow-up. Independent predictors of device explantation for recovery were age <50 years (odds ratio [OR] 2.5), nonischemic etiology (OR 5.4), time since initial diagnosis <2 years (OR 3.4), suboptimal heart failure therapy before implant (OR 2.2), left ventricular end-diastolic diameter <6.5 cm (OR 1.7), pulmonary systolic artery pressure <50 mm Hg (OR 2.0), blood urea nitrogen <30 mg/dL (OR 3.3), and axial-flow device (OR 7.6). Patients with myocarditis (7.7%), postpartum cardiomyopathy (4.4%), and adriamycin-induced cardiomyopathy (4.1%) had highest rates of device explantation for recovery. Use of neurohormonal blockers on left ventricular assist device support was significantly higher in patients who were explanted for recovery. Importantly, 9% of all left ventricular assist device patients who were not explanted for recovery have demonstrated substantial improvement in left ventricular ejection fraction (partial recovery) and had remarkable overlap in clinical characteristic profile compared with patients who were explanted for recovery (complete recovery). Complete and partial recovery rates have declined in parallel with recent changes observed in device indications and technology. Conclusions--Myocardial recovery is a spectrum of improvement rather than a binary clinical end point. One in every 10 left ventricular assist device patients demonstrates partial or complete myocardial recovery and should be targeted for functional assessment and optimization. [ABSTRACT FROM AUTHOR]

Background--Management of hemolysis in the setting of suspected device thrombosis in continuous-low left ventricular assist device patients varies widely, ranging from watchful waiting with intensified antithrombotic therapy to early surgical device exchange. The aim of this study was to compare the outcomes of hemolysis events treated with surgical interventions versus medical management alone. Methods and Results--A retrospective review of Heartmate II continuous-low left ventricular assist device patients at 2 centers from January 2009 to September 2014 was completed. Patients were categorized as surgical management if hemolysis refractory to intensification of standard antithrombotic therapy was treated surgically. The primary end point was the first occurrence of cerebrovascular accident (CVA) or death. Sixty-four hemolysis events occurred in 49/367 patients implanted with Heartmate II continuous-low left ventricular assist devices. Of 49 primary hemolysis events, 24 were treated with surgical interventions. After surgical treatment, 1 patient died and 2 experienced CVAs, as compared with 3 deaths and 9 CVAs in the 25 patients who remained on intensified antithrombotic therapy alone. The 1-year freedom from CVA or death was 87.5% and 49.5% in the surgical and medical cohorts, respectively (P=0.027). Resolution of a primary hemolysis event without CVA or death occurred in 21/24 patients treated with surgical interventions and in 13/25 who remained on medical therapy alone. A similar association between treatment and outcome was noted in the 15 recurrent hemolysis events. Conclusions--Hemolysis refractory to intensification of antithrombotic therapy identifies continuous-low left ventricular assist device patients at major risk for CVA and death. Early device exchange should be considered to minimize these risks. [ABSTRACT FROM AUTHOR]

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