Increased Spironolactone Dosing in Acute Heart Failure Alters Potassium Homeostasis but Does not Enhance Decongestion.

BACKGROUND: The ATHENA-HF (Aldosterone Targeted Neurohormonal Combined with Natriuresis Therapy in Heart Failure) clinical trial found no improvements in natriuretic peptide levels or clinical congestion when spironolactone 100 mg/day for 96 hours was used in addition to usual treatment for acute heart failure. METHODS: We performed a post hoc analysis of ATHENA-HF to determine whether spironolactone treatment induced any detectable pharmacodynamic effects and whether patients with potentially greater aldosterone activity experienced additional decongestion. Trial subjects previously treated with spironolactone were excluded. We first examined for changes in renal potassium handling. Using the baseline serum potassium level as a surrogate marker of spironolactone activity, we then divided each treatment arm into tertiles of baseline serum potassium and explored for differences in laboratory and clinical congestion outcomes. RESULTS: Among spironolactone-naïve patients, the change in serum potassium did not differ after 24 hours or 48 hours but was significantly greater with spironolactone treatment compared to placebo at 72 hours (0.23 ± 0.55 vs 0.03 ± 0.60 mEq/L; P = 0.042) and 96 hours (0.32 ± 0.51 vs 0.13 ± 0.72 mEq/L; P = 0.046). Potassium supplementation was similar at treatment start and at 24 hours, but spironolactone-treated patients required substantially less potassium replacement at 48 hours (24% vs 36%; P = 0.048), 72 hours (21% vs 37%; P = 0.013), and 96 hours (11% vs 38%; P < 0.001). When the treatment arms were divided into tertiles of baseline serum potassium, there were no differences in the 96-hour log N-terminal pro-B-type natriuretic peptide levels, net fluid loss, urine output, or dyspnea relief in any of the potassium groups, with no effect modification by treatment exposure. CONCLUSIONS: Spironolactone 100 mg/day for 96 hours in patients receiving intravenous loop diuresis for acute heart failure has no clear added decongestive ability but does meaningfully limit potassium wasting.

The effect of tablet computer-based telemonitoring added to an established telephone disease management program on heart failure hospitalizations: The Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) III Randomized Controlled Trial.

BACKGROUND: Mobile health applications are becoming increasingly common. Prior work has demonstrated reduced heart failure (HF) hospitalizations with HF disease management programs; however, few of these programs have used tablet computer-based technology. METHODS: Participants with a diagnosis of HF and at least 1 high risk feature for hospitalization were randomized to either an established telephone-based disease management program or the same disease management program with the addition of remote monitoring of weight, blood pressure, heart rate and symptoms via a tablet computer for 90 days. The primary endpoint was the number of days hospitalized for HF assessed at 90 days. RESULTS: From August 2014 to April 2019, 212 participants from 3 hospitals in Massachusetts were randomized 3:1 to telemonitoring-based HF disease management (n = 159) or telephone-based HF disease management (n = 53) with 98% of individuals in both study groups completing the 90 days of follow-up. There was no significant difference in the number of days hospitalized for HF between the telemonitoring disease management group (0.88 ± 3.28 days per patient-90 days) and the telephone-based disease management group (1.00 ± 2.97 days per patient-90 days); incidence rate ratio 0.82 (95% confidence interval, 0.43-1.58; P = .442). CONCLUSIONS: The addition of tablet-based telemonitoring to an established HF telephone-based disease management program did not reduce HF hospitalizations; however, study power was limited.

High- Versus Low-dose Losartan and Serum Potassium: An Analysis From HEAAL.

BACKGROUND: Patients with heart failure (HF) experience frequent alterations of serum potassium. Despite the high risk of events associated with hypokalemia, hyperkalemia is feared by clinicians and often leads to interruption or discontinuation of renin-angiotensin-aldosterone system inhibitors. Data on serum potassium of patients treated with different doses of renin-angiotensin-aldosterone system inhibitors are scarce. METHODS AND RESULTS: The effects of high-dose vs low-dose losartan on clinical outcomes in patients with heart failure (HEAAL) trial randomized 3834 patients with HFrEF intolerant to angiotensin-converting enzyme inhibitors to losartan 150 mg/d (high dose) vs 50 mg/d (low dose). We studied the associations of serum potassium (baseline and time updated) with study outcomes and the effect of the randomized treatment on serum potassium. Patients with higher baseline potassium were older, had diabetes, poorer renal function, and used mineralocorticoid receptor antagonists more frequently. In time-updated models, hyperkalemia (>5.0 or ≥5.5 mmol/L) was not associated with cardiovascular death or the composite of cardiovascular death or HF hospitalization. Hypokalemia (serum potassium of ≤3.5 mmol/L, in particular) was associated with a higher risk of the composite of cardiovascular death or HF hospitalization (hazard ratio [HR] 1.58, 95% confidence interval [CI] 1.19-2.08), all-cause death (HR 1.68, 95% CI 1.26-2.24), and sudden cardiac death or resuscitated cardiac arrest (HR 1.74, 95% CI 1.11-2.73). High-dose losartan decreased the risk of hypokalemia (HR 0.77, 95% CI 0.63-0.92) and increased the risk of hyperkalemia (HR 1.21, 95% CI 1.05-1.39). High-dose losartan decreased the composite of cardiovascular death or HF hospitalizations consistently across the full spectrum of serum potassium at baseline (interaction P = .85). CONCLUSIONS: In patients with HF with reduced ejection fraction intolerant to angiotensin-converting enzyme inhibitors and treated with either high- or low-dose losartan, incident hypokalemia had a stronger association with poor outcomes than incident hyperkalemia. High-dose losartan reduced the incidence of hypokalemia, and its benefits were maintained across the full spectrum of serum potassium.

HFSA Expert Consensus Statement on the Medical Management of Patients on Durable Mechanical Circulatory Support.

The medical management of patients supported with durable continuous flow left ventricular assist device (LVAD) support encompasses pharmacological therapies administered in the preoperative, intraoperative, postoperative, and chronic LVAD support stages. As patients live longer on LVAD support, the risks of LVAD-related complications and progression of cardiovascular and other diseases increase. Using existing data from cohort studies, registries, randomized trials, and expert opinion, this Heart Failure Society of America Consensus Document on the Medical Management of Patients on Durable Mechanical Circulatory Support offers best practices on the management of patients on durable mechanical circulatory support, focusing on pharmacological therapies administered to patients on continuous flow LVADs. Although quality data in the LVAD population are few, the use of guideline-directed heart failure medical therapies and the importance of blood pressure management, right ventricular preload and afterload optimization, and antiplatelet and anticoagulation regimens are discussed. Recommended pharmacological regimens used to mitigate or treat common complications encountered during LVAD support, including arrhythmias, vasoplegia, mucocutaneous bleeding, and infectious complications, are addressed. Finally, this document touches on important potential pharmacological interactions from antidepressants and herbal and nutritional supplements of relevance to providers of patients on LVAD support.

Rationale and Design of the Proactive-HF Trial for Managing Patients With NYHA Class III Heart Failure by Using the Combined Cordella Pulmonary Artery Sensor and the Cordella Heart Failure System.

BACKGROUND: Optimizing guideline-directed medical therapy (GDMT) and monitoring congestion in patients with heart failure (HF) are key to disease management and preventing hospitalizations. A pulmonary artery pressure (PAP)-guided HF management system providing access to body weight, blood pressure, heart rate, blood oxygen saturation, PAP, and symptoms, may provide new insights into the effects of patient engagement and comprehensive care for remote GDMT titration and congestion management. METHODS: The PROACTIVE-HF study was originally approved in 2018 as a prospective, randomized, controlled, single-blind, multicenter trial to evaluate the safety and effectiveness of the Cordella PAP Sensor in patients with HF and with New York Heart Association (NYHA) functional class III symptoms. Since then, robust clinical evidence supporting PAP-guided HF management has emerged, making clinical equipoise and enrolling patients into a standard-of-care control arm challenging. Therefore, PROACTIVE-HF was changed to a single-arm trial in 2021 with prespecified safety and effectiveness endpoints to provide evidence for a similar risk/benefit profile as the CardioMEMS HF System. CONCLUSION: The single-arm PROACTIVE-HF trial is expected to further demonstrate the benefits of PAP-guided HF management of patients with NYHA class III HF. The addition of vital signs, patient engagement and self-reported symptoms may provide new insights into remote GDMT titration and congestion management.

PROMIS: Physical, Mental and Social Health Outcomes Improve From Before to Early After LVAD Implant: Findings From the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) Study.

Study participants (n = 272) completed 12 Patient-Reported Outcomes Measurement Information System (PROMIS) physical, mental and social health measures (questionnaires) prior to implantation of a left ventricular assist device (LVAD) and again at 3 and 6 months postimplant. All but 1 PROMIS measure demonstrated significant improvement from pre-implant to 3 months; there was little change between 3 and 6 months. Because PROMIS measures were developed in the general population, patients with an LVAD, their caregivers and their clinicians can interpret the meaning of PROMIS scores in relation to the general population, helping them to monitor a return to normalcy in everyday life.

Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial.

BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.

Assessment of adverse events for a home-use intense pulsed light hair removal device using postmarketing surveillance.

BACKGROUND AND OBJECTIVES: Home-use intense pulsed light (IPL) hair removal devices are convenient for consumers. Consumer safety associated with home-use IPL devices, however, remains a subject of interest. In this descriptive analysis, we assessed the most commonly reported adverse events (AEs) for a home-use IPL device from postmarketing surveillance and qualitatively compared these with AEs from clinical studies and medical device reports of home-use IPL treatments. MATERIALS AND METHODS: For this analysis of voluntary reports, we queried a distributor's postmarketing database for IPL devices for the period beginning January 1, 2016, to December 31, 2021. All sources of comments, for example, phone, e-mail, company-sponsored web sites, were included in the analysis. AE data were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. Also, we conducted a PubMed search to identify AE profiles from existing literature on home-use IPL devices and we searched the Manufacturer and User Facility Device Experience (MAUDE) database for reports on home-use IPL devices. These results were qualitatively compared to the data in the postmarketing surveillance database. RESULTS: A total of 1692 cases involving IPL were identified from voluntary reports of AEs between 2016 and 2021. The shipment-adjusted reporting rate for AE cases (number of AE cases/100,000 shipped IPL devices) was 67/100,000 during this 6-year period. The most commonly reported AEs were pain of skin 27.8% (470/1692), "thermal burn" 18.7% (316/1692), and erythema 16.0% (271/1692). Among the top 25 AEs reported, no unexpected health events were observed. The reported AEs were qualitatively similar to the pattern seen in clinical studies and the MAUDE database associated with such home-use IPL treatments. CONCLUSION: This is the first such report documenting AEs for home-use IPL hair removal from a postmarketing surveillance program. These data are supportive of the safety of such home-use low-fluence IPL technology.

A scoping review of the utility of self-report and informant-report prospective memory measures.

There has been increased use of self-report prospective memory (PM) scales in recent years, despite uncertainty about their validity. This study reviewed how self-and informant-report PM questionnaires have been used in the assessment of PM. We evaluated relationships between self-report, informant-report, and performance-based PM measures, and the validity of using self-report measures in detecting PM impairments and monitoring intervention outcomes. The scoping review methodology of Arksey and O'Malley (2005. Scoping studies: Towards a methodological framework. International Journal of Social Research Methodology, 8(1), 19-32) was used. Database searches yielded 488 published studies that used the Prospective Memory Questionnaire (PMQ), Prospective and Retrospective Memory Questionnaire (PRMQ), Comprehensive Assessment of PM (CAPM), and Brief Assessment of PM (BAPM). The self-report and informant-report measures of PM had weak- to moderate-strength relationships with performance-based PM measures. Some self-report PM scales could detect PM impairments and monitor intervention outcomes, however few studies had investigated this. The findings indicated that self- and informant-report scales measure different constructs to performance-based measures of PM. It is recommended that these scales be used alongside performance-based measures to provide complementary and comprehensive assessments of PM. Further research into assessment of PM using self-report measures will aid assessment and treatment choices.

Radiographic risk factors for intracranial hemorrhage in patients with left ventricular assist devices.

OBJECTIVE: Intracranial hemorrhage (ICH) in patients with left ventricular assist devices (LVAD) is a devastating complication. Demographic risk factors for ICH in LVAD patients are defined, however anatomic predispositions to ICH are unknown. We sought to interrogate intracranial radiographic risk factors for ICH in LVAD patients. METHODS: We reviewed 440 patients who received an LVAD from 2008-2021. We selected patients with CT scans of the head either before or after LVAD placement, but typically within 5 years. 288 patients (21 ICH, 267 Control) with imaging were included. A detailed chart review was performed on demographics, radiographic features, and management. RESULTS: The incidence of ICH in our total cohort was 8.6% (38/440). The presence of pump thrombosis (p=0.001), driveline infection (p=0.034), other hemorrhage (p=0.001), or previous placement of a cardio-defibrillator (p=.003) was associated with increased risk for ICH. An analysis of imaging revealed that the presence of a mass (p=0.006), vascular pathology (p=0.001), and microangiopathy (p=0.04) was significantly associated with ICH in LVAD patients. These radiographic features were validated with a multivariate logistic regression which confirmed presence of a mass (aOR 332.1, 95% CI: 14.7-7485.1, p<0.001), vascular pathology (aOR 69.7, 95% CI: 1.8-2658.8, p=0.022), and microangiopathy (aOR 6.5, 95% CI: 1.1-37.6, p=0.035) were independently associated with ICH. CONCLUSION: Radiographic evidence of microangiopathy, intracranial mass, and vascular pathology are independent risk factors for ICH which are readily identified by imaging. We advocate that CT imaging be used to further stratify patients at highest risk of ICH during treatment with an LVAD.

Understanding Longitudinal Changes in Pulmonary Vascular Resistance After Left Ventricular Assist Device Implantation.

BACKGROUND: Elevated pulmonary vascular resistance (PVR) is common in patients with advanced heart failure. PVR generally improves after left ventricular assist device (LVAD) implantation, but the rate of decrease has not been quantified and the patient characteristics most strongly associated with this improvement are unknown. METHODS AND RESULTS: We analyzed 1581 patients from the Interagency Registry for Mechanically Assisted Circulatory Support registry who received a primary continuous-flow LVAD, had a baseline PVR of ≥3 Wood units (WU), and had PVR measured at least once postoperatively. Multivariable linear mixed effects modeling was used to evaluate independent associations between postoperative PVR and patient characteristics. PVR decreased by 1.53 WU (95% confidence interval [CI] 1.27-1.79 WU) per month in the first 3 months postoperatively, and by 0.066 WU (95% CI 0.060-0.070 WU) per month thereafter. Severe mitral regurgitation at any time during follow-up was associated with a 1.29 WU (95% CI 1.05-1.52 WU) higher PVR relative to absence of mitral regurgitation at that time. In a cross-sectional analysis, 15%-25% of patients had persistently elevated PVR of ≥3 WU at any given time within 36 months after LVAD implantation. CONCLUSION: The PVR tends to decrease rapidly early after implantation, and only more gradually thereafter. Residual mitral regurgitation may be an important contributor to elevated postoperative PVR. Future research is needed to understand the implications of elevated PVR after LVAD implantation and the optimal strategies for prevention and treatment.

Untwist the twist: instant hemodynamic improvement in known HeartMate 3 complication.

The HeartMate 3 [HM3 (Abbott, Abbott Park, Illinois)] is a left-ventricular assist device (LVAD) with excellent clinical results. Outflow graft occlusion as a complication secondary to outflow graft twisting was reported to occur in 1.6% within the MOMENTUM 3 trial. The anti-twist metal clip or modified bend relief is made to prevent this complication currently, however, there remain large numbers of early implanted HM3 which may develop this complication. There are limited reports illustrating diagnosis, surgical repair, and post-repair hemodynamic changes of these complications. Thus, we present a case of successful diagnosis and surgical repair of an outflow graft twist. Simple procedure through thoracotomy without cardiopulmonary bypass provides significant immediate hemodynamic improvement.

Left thoracotomy vs full sternotomy for centrifugal durable LVAD implantation: 1-year outcome comparison post-LVAD and post-heart transplantation.

Left ventricular assist device (LVAD) implantations have traditionally been approached through a full median sternotomy (FS). Recently, a minimally invasive left thoracotomy (LT) approach has been popularized. This study sought to compare the outcomes of FS and LT patients post-primary LVAD implantation and post-subsequent heart transplant (HT). This was a single-center retrospective study. 83 patients who underwent primary centrifugal durable LVAD implantation from January 2014 to June 2018 were included (FS, n = 41; LT, n = 42). 41 patients had a subsequent HT (FS, n = 19; LT, n = 22). Pre-operative patient demographics, intraoperative variables, post-operative 1-year survival, length of hospital stay, complications, and outcomes for LVAD implantation and following HT were analyzed. Intraoperative data showed that the LT group had a 23.4% longer mean LVAD implant surgical time (p < 0.01). One-year post-LVAD survival was similar between the two groups (p = 0.05). Complication rates, with the exception of the rate of hemorrhagic stroke (p = 0.04) post-LVAD implant were similar. One-year survival post-HT was similar between groups (p = 0.35). Complication rates and mean length of hospital stay were also similar (p = 1.0) post-HT. Our study demonstrated that LT approach does not negatively affect post-LVAD implantation or post-HT outcomes. Further, larger studies may determine more detailed effects of LT approach.

Sensitization in Heart Transplantation: Emerging Knowledge: A Scientific Statement From the American Heart Association.

Sensitization, defined as the presence of circulating antibodies, presents challenges for heart transplant recipients and physicians. When present, sensitization can limit a transplantation candidate's access to organs, prolong wait time, and, in some cases, exclude the candidate from heart transplantation altogether. The management of sensitization is not yet standardized, and current therapies have not yielded consistent results. Although current strategies involve antibody suppression and removal with intravenous immunoglobulin, plasmapheresis, and antibody therapy, newer strategies with more specific targets are being investigated.

Outcomes of Severely Obese Patients Supported by a Centrifugal-Flow Left Ventricular Assist Device.

BACKGROUND: Ventricular assist devices provide improved outcomes for patients with advanced heart failure, but their benefit in the severely obese is not well documented. METHODS: Patients enrolled in the HeartWare ADVANCE trial (n=382) were divided into 2 body mass index (BMI) groups. Patients with severe obesity (>35 kg/m2) were compared with a control group with BMI ≤35 kg/m2. The association of BMI with survival was tested using Kaplan-Meier analysis and major adverse events were compared. RESULTS: At implantation, 48 (13%) of patients were severely obese. There was no difference in survival through 2 years of support between severely obese patients and the control group. Severely obese patients were at higher risk of driveline infection (P = .01) and acute renal dysfunction (P = .002). Both groups experienced similar improvements in quality of life. Functional capacity improved in both severely obese and control patients, although severely obese patients had smaller improvements than controls in their 6-minute walk scores. CONCLUSIONS: Despite an increased risk of adverse events, severe obesity was not associated with reduced survival or quality of life. A better understanding of the risks and benefits of left ventricular assist device therapy in obese patients will help in the shared decision-making of the patient selection process.

Timing and Trends of Right Atrial Pressure and Risk of Right Heart Failure After Left Ventricular Assist Device Implantation.

BACKGROUND: Elevated right atrial pressure (RAP) is associated with poor outcomes after left ventricular assist device (LVAD) implantation. However, the optimal time for RAP measurement and the importance of resolution of right heart congestion prior to LVAD implantation remain unclear. METHODS AND RESULTS: We performed a retrospective cohort study of 134 consecutive LVAD recipients from our institution. Congestion was defined as RAP ≥ 14 mmHg and was assessed at hospital admission and implant. The primary outcome was death or right ventricular assist device (RVAD) implantation. When stratified by congestion status at admission, congested and non-congested patients had similar event-free survival rates (hazard ratio [HR]: 1.2, 95% confidence interval [CI]: 0.6-2.6). However, when stratified at implant, congested patients had a higher rate death or RVAD implantation (HR: 2.5, 95% CI: 1.1-5.6). Patients were then divided into 4 groups based on their trajectory of congestion status: no congestion, resolved congestion, new congestion, or persistent congestion. Patients with no congestion and resolved congestion had similar outcomes, whereas patients with persistent congestion had a markedly increased rate of death or RVAD implantation (HR: 3.1, 95% CI: 1.3-7.6). CONCLUSION: RAP at LVAD implantation is more strongly associated with postoperative outcomes than admission RAP. Patients not responsive to decongestive therapies, with persistently elevated RAP, represent a high-risk cohort for adverse outcomes following LVAD implantation.

Evaluation and Management of Right-Sided Heart Failure: A Scientific Statement From the American Heart Association.

BACKGROUND AND PURPOSE: The diverse causes of right-sided heart failure (RHF) include, among others, primary cardiomyopathies with right ventricular (RV) involvement, RV ischemia and infarction, volume loading caused by cardiac lesions associated with congenital heart disease and valvular pathologies, and pressure loading resulting from pulmonic stenosis or pulmonary hypertension from a variety of causes, including left-sided heart disease. Progressive RV dysfunction in these disease states is associated with increased morbidity and mortality. The purpose of this scientific statement is to provide guidance on the assessment and management of RHF. METHODS: The writing group used systematic literature reviews, published translational and clinical studies, clinical practice guidelines, and expert opinion/statements to summarize existing evidence and to identify areas of inadequacy requiring future research. The panel reviewed the most relevant adult medical literature excluding routine laboratory tests using MEDLINE, EMBASE, and Web of Science through September 2017. The document is organized and classified according to the American Heart Association to provide specific suggestions, considerations, or reference to contemporary clinical practice recommendations. RESULTS: Chronic RHF is associated with decreased exercise tolerance, poor functional capacity, decreased cardiac output and progressive end-organ damage (caused by a combination of end-organ venous congestion and underperfusion), and cachexia resulting from poor absorption of nutrients, as well as a systemic proinflammatory state. It is the principal cause of death in patients with pulmonary arterial hypertension. Similarly, acute RHF is associated with hemodynamic instability and is the primary cause of death in patients presenting with massive pulmonary embolism, RV myocardial infarction, and postcardiotomy shock associated with cardiac surgery. Functional assessment of the right side of the heart can be hindered by its complex geometry. Multiple hemodynamic and biochemical markers are associated with worsening RHF and can serve to guide clinical assessment and therapeutic decision making. Pharmacological and mechanical interventions targeting isolated acute and chronic RHF have not been well investigated. Specific therapies promoting stabilization and recovery of RV function are lacking. CONCLUSIONS: RHF is a complex syndrome including diverse causes, pathways, and pathological processes. In this scientific statement, we review the causes and epidemiology of RV dysfunction and the pathophysiology of acute and chronic RHF and provide guidance for the management of the associated conditions leading to and caused by RHF.

The Neutrophil-Lymphocyte Ratio and Survival During Left Ventricular Assist Device Support.

BACKGROUND: Systolic heart failure (HF) is a low-grade systemic inflammatory state. Neutrophil-lymphocyte ratio (NLR) is a nonspecific inflammatory marker with prognostic value in HF. We aimed to determine the relationship between NLR and mortality during left ventricular assist device (LVAD) support. METHODS AND RESULTS: We retrospectively reviewed LVAD recipients implanted in the years 2010-2018. NLR was recorded before LVAD implantation and at intervals during LVAD support; pre-LVAD and 90-day LVAD NLRs were compared. Cox proportional hazard models were constructed to study the impact of NLR, both before LVAD implantation and at 90 days with LVAD, on mortality during subsequent LVAD support. Among 301 subjects, the median pre-LVAD NLR was 4.7 (interquartile range 3.0-8.0). Higher pre-LVAD NLR was independently associated with increased mortality during a median 324 days of LVAD support (adjusted hazard ratio [HR] 1.03, 95% confidence interval [CI] 1.01-1.06; P = .012, adjusted for pre-LVAD age, HF etiology, white blood count, hemoglobin, blood urea nitrogen, and sodium). After LVAD implantation, the NLR rose initially and then plateaued lower by day 90. Despite the mean decrease, higher 90-day LVAD NLR remained independently associated with increased mortality (adjusted HR 1.06, 95% CI 1.01-1.13; P = .033, stratified by early infection events). CONCLUSIONS: Higher pre-LVAD NLR is independently associated with mortality during LVAD support. NLR improves during LVAD support, but even accounting for early infections, a higher NLR at day 90 remains associated with subsequent mortality.

Intraoperative Hemodynamic and Echocardiographic Measurements Associated With Severe Right Ventricular Failure After Left Ventricular Assist Device Implantation.

BACKGROUND: Severe right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation increases morbidity and mortality. We investigated the association between intraoperative right heart hemodynamic data, echocardiographic parameters, and severe versus nonsevere RVF. METHODS: A review of LVAD patients between March 2013 and March 2016 was performed. Severe RVF was defined by the need for a right ventricular mechanical support device, inotropic, and/or inhaled pulmonary vasodilator requirements for >14 days. From a chart review, the right ventricular failure risk score was calculated and right heart hemodynamic data were collected. Pulmonary artery pulsatility index (PAPi) [(pulmonary artery systolic pressure - pulmonary artery diastolic pressure)/central venous pressure (CVP)] was calculated for 2 periods: (1) 30 minutes before cardiopulmonary bypass (CPB) and (2) after chest closure. Echocardiographic data were recorded pre-CPB and post-CPB by a blinded reviewer. Univariate logistic regression models were used to examine the performance of hemodynamic and echocardiographic metrics. RESULTS: A total of 110 LVAD patients were identified. Twenty-five did not meet criteria for RVF. Of the remaining 85 patients, 28 (33%) met criteria for severe RVF. Hemodynamic factors associated with severe RVF included: higher CVP values after chest closure (18 ± 9 vs 13 ± 5 mm Hg; P = .0008) in addition to lower PAPi pre-CPB (1.2 ± 0.6 vs 1.7 ± 1.0; P = .04) and after chest closure (0.9 ± 0.5 vs 1.5 ± 0.8; P = .0008). Post-CPB echocardiographic findings associated with severe RVF included: larger right atrial diameter major axis (5.4 ± 0.9 vs 4.9 ± 1.0 cm; P = .03), larger right ventricle end-systolic area (22.6 ± 8.4 vs 18.5 ± 7.9 cm; P = .03), lower fractional area of change (20.2 ± 10.8 vs 25.9 ± 12.6; P = .04), and lower tricuspid annular plane systolic excursion (0.9 ± 0.2 vs 1.1 ± 0.3 cm; P = .008). Right ventricular failure risk score was not a significant predictor of severe RVF. Post-chest closure CVP and post-chest closure PAPi discriminated severe from nonsevere RVF better than other variables measured, each with an area under the curve of 0.75 (95% CI, 0.64-0.86). CONCLUSIONS: Post-chest closure values of CVP and PAPi were significantly associated with severe RVF. Echocardiographic assessment of RV function post-CPB was weakly associated with severe RVF.

Increased Plasma-Free Hemoglobin Levels Identify Hemolysis in Patients With Cardiogenic Shock and a Trans valvular Micro-Axial Flow Pump.

Hemolysis is a potential limitation of percutaneously delivered left-sided mechanical circulatory support pumps, including trans valvular micro-axial flow pumps (TVP). Hemolytic biomarkers among durable left ventricular assist devices include lactate dehydrogenase (LDH) >2.5 times the upper limit of normal (ULN) and plasma-free hemoglobin (pf-Hb) >20 mg/dL. We examined the predictive value of these markers among patients with cardiogenic shock (CS) receiving a TVP. We retrospectively studied records of 116 consecutive patients receiving an Impella TVP at our institution between 2012 and 2017 for CS. Twenty-three met inclusion/exclusion criteria, and had sufficient pf-Hb data for analysis. Area under receiver-operator characteristic (ROC) curve for diagnosing hemolysis were calculated. Mean age was 62 ± 14 years and ejection fraction was 15 ± 5%. Mean duration of support was 5.4 ± 3.5 days. Pre-device LDH levels were >2.5x ULN in 71% (n = 5/7) of 5.0 and 29% of CP patients, while pre-device pf-Hb levels were >20 mg/dL in 14% (n = 1/7) of 5.0 and 25% (n = 4/16) of CP patients. Given elevated baseline LDH and pf-Hb levels, we defined hemolysis as a pf-Hb level >40 mg/dL within 72 h post-implant plus clinical evidence of device-related hemolysis. We identified that 30% (n = 7/23) had device-related hemolysis. Using ROC curve-derived cut-points, an increase in delta pf-Hb by >27mg/dL, not delta LDH, within 24 h after TVP implant (delta pf-Hb: C-statistic = 0.79, sensitivity: 57%, specificity: 93%, p <0.05) was highly predictive of hemolysis. In conclusion, we identified a change in pf-Hb, not LDH, levels is highly sensitive and specific for hemolysis in patients treated with a TVP for CS.