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On June 3, 2021 Medtronic, Inc announced discontinuation of the HVAD left ventricular assist device. The purpose of this analysis was to provide summary data on surgical risks of HVAD to HeartMate 3 exchange and compare survival after HVAD to HeartMate 3 exchange to survival after primary HVAD implantation.Three cohorts within The Society of Thoracic Surgeons Intermacs database were identified: primary HVAD implant cohort (January 2017 to March 2021, n = 3797), HVAD to HeartMate 3 exchange cohort (December 2017 to March 2021, n = 45), and HVAD to HVAD exchange cohort (January 2017 to March 2021, n = 234). Mortality after HVAD to HeartMate 3 exchange was modeled and compared with the constant hazard phase for risk of mortality while on continued HVAD support. As a secondary analysis outcomes and survival were compared between patients who underwent HVAD to HeartMate 3 and HVAD to HVAD exchange.HVAD to HeartMate 3 exchange was associated with significantly reduced survival compared with survival while remaining on HVAD support (6 months after exchange, 73.8% [70% confidence interval, 68.6-77.8] vs 79.0% [70% confidence interval, 78.3-79] for continued HVAD support). Compared with HVAD to HVAD exchange, survival was higher after replacement with HeartMate 3 (1 year: 85.9% [70% confidence interval, 79.5-90.5] vs 66.6% [70% confidence interval, 63.0-70.0], P = .009).Compared with continued support on HVAD, an exchange to HeartMate 3 was found to be associated with a significant increase in mortality. For patients who required pump exchange on HVAD support, exchange to HeartMate 3 demonstrated superior survival. Currently there is insufficient evidence to support elective exchange from an HVAD to HeartMate 3.

Pulmonary hypertension (PH) is a risk factor for morbidity and mortality in patients undergoing surgery and anesthesia. This document represents the first international consensus statement for the perioperative management of patients with pulmonary hypertension and right heart failure. It includes recommendations for managing patients with PH being considered for surgery, including preoperative risk assessment, planning, intra- and postoperative monitoring and management strategies that can improve outcomes in this vulnerable population. This is a comprehensive document that includes common perioperative patient populations and surgical procedures with unique considerations.

Whether pre left ventricular assist device (LVAD) sarcopenia is associated with higher incidence of gastrointestinal bleeding (GIB) on LVAD support remains unknown.To study the association between preoperative sarcopenia and post LVAD GIB events, we performed a retrospective, multi-centered study including patients with chest CTs performed ≤ 3 months prior to LVAD implantation at the University of Minnesota (n = 143) and Houston Methodist Hospital (n = 133). To quantify sarcopenia, unilateral pectoralis muscle mass indexed to body surface area (PMI) and attenuation (approximated by mean Hounsfield units; PHUThe study cohort included 276 LVAD recipients with 43 % designated as bridge to transplant at the time of LVAD implantation. High pectoralis muscle mass and tissue attenuation were both protective against GIB events. Each 5 unit increase in PHUPreoperative sarcopenia, as quantified by pectoralis muscle size and attenuation, was associated with the development of recurrent GI bleeding after LVAD implantation. These CT quantitative measures appear to predict not only early mortality but morbidity on LVAD as well.

BACKGROUND: While sex differences in heart transplantation (HT) waitlist mortality have been previously described, waitlist and HT outcomes by sex of patients in the highest urgency strata (Status 1) since implementation of the 2018 allocation system change in the United States are unknown. We hypothesized that women listed as Status 1 may have worse outcomes due to adverse events on temporary mechanical circulatory support. METHODS: The analysis included adult, single-organ HT waitlist candidates listed as Status 1 at any time while listed, after the HT allocation system change (from October 18, 2018 through March 31, 2022). The primary outcome was the rate of HT by sex, assessed using multivariable competing risk analysis where waitlist removal for death or clinical deterioration was the competing event. Post-HT survival by sex of waitlist candidates transplanted as a Status 1 was also compared. RESULTS: Of 1120 Status 1 waitlist candidates (23.8% women), women had a lower rate of HT compared to men (adjusted hazard ratio, 0.74 [95% CI, 0.62–0.88]; P P =0.026). Calculated panel reactive antibody did not account for all the harm observed. Post-HT survival of Status 1 candidates by sex was similar (adjusted hazard ratio, 1.13 [95% CI, 0.62–2.06]; P =0.70). CONCLUSIONS: Women have a lower rate of HT and higher rate of delisting for death or clinical deterioration at the highest urgent status, which appears to be mediated but not fully explained by calculated panel reactive antibody levels. Further investigation into the safety profile of temporary mechanical circulatory support devices in women is needed.

Background: Hemodynamic-guided management with a pulmonary artery pressure (PAP) sensor (CardioMEMS TM ) is effective in reducing heart failure hospitalization (HFH) in patients with chronic heart failure (HF). This study aims to determine the feasibility and clinical utility of the CardioMEMS HF system to manage patients supported with LVADs. Methods: In this multi-center prospective study, we followed patients with HeartMate II TM (n=52) or HeartMate 3 TM (n=49) LVADs and with CardioMEMS PA Sensors, and measured PAP, 6-minute walk distance (6MWD), quality of life (EQ-5D-5L scores), and HFH rates through 6 months. Patients were stratified as responders (R) and non-responders (NR) to reductions in PA diastolic pressure (PAD). Results: There were significant reductions in PAD from baseline to 6 months in R (21.5 to 16.5 mmHg, p Conclusions: LVAD patients managed with CardioMEMS with a significant reduction in PAD at 6 months showed improvements in 6MWD. Maintaining PAD < 20 mmHg was associated with fewer HF hospitalizations. Hemodynamic-guided management of LVAD patients with CardioMEMS is feasible and may result in functional and clinical benefits. Prospective evaluation of ambulatory hemodynamic management in LVAD patients is warranted. Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03247829

Preoperative variables can predict short term left ventricular assist device (LVAD) survival, but predictors of extended survival remain insufficiently characterized.Patients undergoing LVAD implant (2012-2018) in the Intermacs registry were grouped according to time on support: short-term (1 year, n = 7,483), mid-term (MT, 1-3 years, n = 5,976) and long-term (LT, ≥3 years, n = 3,015). Landmarked hazard analyses (adjusted hazard ratio, HR) were performed to identify correlates of survival after 1 and 3 years of support.After surviving 1 year of support, additional LVAD survival was less likely in older (HR 1.15 per decade), Caucasian (HR 1.22) and unmarried (HR 1.16) patients (p0.05). After 3 years of support, only 3 preoperative characteristics (age, race, and history of bypass surgery, p0.05) correlated with extended survival. Postoperative events most negatively influenced achieving LT survival. In those alive at 1 year or 3 years, the occurrence of postoperative renal (creatinine HR MT = 1.09; LT HR = 1.10 per mg/dl) and hepatic dysfunction (AST HR MT = 1.29; LT HR = 1.34 per 100 IU), stroke (MT HR = 1.24; LT HR = 1.42), infection (MT HR = 1.13; LT HR = 1.10), and/or device malfunction (MT HR = 1.22; LT HR = 1.46) reduced extended survival (all p ≤ 0.03).Success with LVAD therapy hinges on achieving long term survival in more recipients. After 1 year, extended survival is heavily constrained by the occurrence of adverse events and postoperative end-organ dysfunction. The growth of destination therapy intent mandates that future LVAD studies be designed with follow up sufficient for capturing outcomes beyond 24 months.

The Revivent TC System (BioVentrix Inc, San Ramon, CA) enables a less invasive approach for left ventricular reshaping and scar exclusion in selected patients with ischemic cardiomyopathy. Although the system is designed to improve quality of life and to promote reverse remodeling, patients can still progress to end-stage heart failure requiring advanced therapies. This report describes a case of left ventricular assist device surgery in a patient 16 months after Revivent System implantation. The planning process and surgical technique proved to be complex. This case report can help provide guidance to advanced heart failure teams who encounter patients with the Revivent System who require left ventricular assist device support.

The purpose of this analysis is to determine whether pectoralis muscle measures quantified on pre left ventricular assist device (LVAD) computerized tomography (CT) scans can identify subgroups of patients with differential disease severity within each Interagency Registry for Mechanical Circulatory Support (INTERMACS) profile. Patients with chest CTs performed ≤3 months before LVAD implantation at University of Minnesota (n = 143) and Houston Methodist Hospital (n = 133) were identified from the larger LVAD cohorts (University of Minnesota n = 353, Houston Methodist =278). Unilateral Pectoralis muscle mass indexed to body surface area and pectoralis muscle attenuation were measured on preoperative chest CT scans. Patients within each INTERMACS profile were separated into HIGH and LOW PEC muscle groups. Kaplan-Meier and multivariable cox regression analyses were performed to compare mortality among INTERMACS profiles by HIGH and LOW PEC muscle groups. INTERMACS 3 and 4 patients in the HIGH PEC groups had the highest survival on LVAD support (1 year survival 85% vs. 68%, log rank P = 0.0001). Being in this group was associated with a 60% reduction in the hazards rate (HR) of death after LVAD (adjusted HR 0.40, 95% confidence interval 0.25-0.62). Additionally, renal function deterioration in the year before LVAD was associated with lower INTERMACS profiles and lower measured pectoralis muscle tissue attenuation at the time of LVAD implantation. INTERMACS 3 and 4 patients with the highest pectoralis muscle measures had the best survival after LVAD. The association between renal function deterioration and sarcopenia suggests these muscle changes are progressive. Computerized tomography quantification of sarcopenia may help identify optimal LVAD implantation timing.

Purpose To provide safety and outcomes data on LVAD recipients referred for cardiac rehabilitation (CR). Methods A single center continuous-flow LVAD cohort (n=505) was searched for patients with information on CR participation (n=292). The analysis was then limited to LVAD recipients who fit into one of three main CR categories: those who graduated CR (n=138), those who would have been able to participate but declined (n=61), and those who were too sick to complete or start CR (n=28). To assess the association between CR categories and mortality and hospitalizations on LVAD support, multivariate cox regression and negative binomial regression analyses were performed, respectively. Results The mean age of the cohort with CR data available was 59 +/- 14 years, 44% (128/292) were bridge to transplant (BTT), and 40% (114/292) received a HeartMate 3 device. Among those who started CR and had the opportunity to finish (enough follow up time, insurance coverage), 79% graduated. Those who graduated CR had a 96% survival at 1 year (95% CI 91-98). In the unadjusted and adjusted analyses, those who graduated CR had the highest survival and the lowest incidence rates of hospitalization among the CR categories (Table). Conclusion This study is the largest to date to report outcomes of LVAD recipients referred for cardiac rehabilitation. The lower readmission rates and high survival in the group that graduated cardiac rehab provides further evidence for the safety of CR in LVAD recipients.

Rationale: A definitive dietary preparation recommendation is not possible based on literature in achievement of myocardial suppression for diagnosis of cardiac sarcoidosis (CS) with 18F-FDG PET/CT. Our goal is to compare three different dietary preparations in achievement of the best myocardial suppression and CS diagnosis. Methods: We retrospectively reviewed and compared three dietary preparations used at our institution. Three different diets were applied from 03/2014 to 12/2019. 24-h ketogenic diet with overnight fasting (n = 94); 18h-fasting (n = 44); 72-h daytime ketogenic diet with 3-day overnight fasting (n = 98). The interpretation of initial reports was recorded, and an independent radiologist (observer) retrospectively re-evaluated each case regarding CS diagnosis (Negative, Positive, Indeterminant) and myocardial suppression (Complete, Failed, Partial). Interobserver agreement was analyzed. We measured MaxSUV from bloodpool, liver, and the most suppressed normal myocardium. Results: We identified superior myocardial suppression with the 72-h preparation indicated by a higher bloodpool/myocardium and liver/myocardium ratios (P

Background We have previously demonstrated that pectoralis muscle mass and tissue attenuation obtained on preoperative CT scans were powerful predictors of mortality after left ventricular assist device implantation. In this analysis, we confirm our findings in a separate left ventricular assist device implantation cohort, and we present a novel, user-friendly mortality-prediction model incorporating these measures. Methods and Results Patients with chest CTs performed ≤ 3 months prior to left ventricular assist device implantation at University of Minnesota (n = 143) and Houston Methodist Hospital (n = 133) were identified. Unilateral pectoralis muscle mass indexed to body surface area (PMI) and attenuation (approximated by mean Hounsfield units) (PHUm) were measured on preoperative chest CT scans. To develop a prediction model incorporating pectoralis muscle measures, we implemented a cross-validated model-selection approach using Cox proportional hazards regression models. The final model included PHUm, PMI, African American race, creatinine, total bilirubin, body mass index, bridge to transplant, and presence or absence of contrast. Receiver-operating characteristic curves for 30-, 90- and 365-day survival were generated. The area under the curve for the model at 30, 90 and 365 days was 0.78, 0.76 and 0.76, respectively. Conclusions The Minnesota Pectoralis Risk Score had favorable discrimination in this multicenter dataset. These skeletal-muscle measures appear to add important information to preoperative risk assessment.

BACKGROUND: The 2018 United States heart allocation system offers an accelerated pathway for heart transplantation to the most urgent patients. OBJECTIVES: To determine whether the new allocation system resulted in lower likelihood of candidate recovery. METHODS: Adult patients waitlisted for heart transplantation with temporary MCS at the time of initial listing between 2010 and 2020 in the UNOS registry were included. Competing events of heart transplantation, waitlist death or delisting for deteriorating condition, and delisting for improved condition (candidate recovery) were analyzed in the new versus old heart allocation system. RESULTS: 688 patients were waitlisted with VA-ECMO or surgical non-dischargeable BIVAD (Status 1 or old 1A). 2237 patients were waitlisted with IABP, percutaneous LVAD, or surgical non-dischargeable LVAD (Status 2 or old 1A). Patients waitlisted with VA-ECMO or non-dischargeable BIVAD had significantly shorter median waitlist times (5 vs. 31 days), higher incidence for cardiac transplantation (81.5% vs. 43.0%), and lower incidence of candidate recovery (1.5% vs. 7.9%) in the new vs. old heart allocation system (all p

After the implementation of the 2018 US heart transplant allocation system, the experience and perceptions of heart transplant clinicians have not been well-cataloged.This web-based survey of both heart failure cardiologists and surgeons examined physician perspectives about the policy changes and whether the system is meeting its intended goals. The majority of participants (94%, n = 113) responded that the 2018 heart allocation system requires modification. Eighty-four percent reported using more temporary mechanical circulatory support to achieve higher status and 86% were concerned about the change in physician behavior and practices under the new system.Suggestions for possible improvement included higher status for patients on durable left ventricular assist device support, changes to criteria for status 2, modification of status exceptions, and advocacy for a heart allocation score.

In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device.We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years.This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group.Among patients with advanced heart failure, a fully magnetically levitated centrifugal-flow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.).

Background: The association between ventricular arrhythmias (VAs) and mortality in patients supported by continuous flow left ventricular assist devices (LVAD) remains controversial. Objective: To evaluate the association between pre-implantation, early (≤30 day) post-implantation VAs and mortality in bridge to transplant (BTT) and destination therapy (DT) LVAD patients, separately. The risk factors for post LVAD VAs were also investigated.Methods: In this observational cohort study, we included 341 patients who received a first time, continuous flow LVAD between January 1st 2010 and July 30th 2018. We used Kaplan Meier curves and multivariable cox regression analyses to study the association between VAs and mortality in the BTT and DT populations.Results: The mean age of the cohort was 58 ± 14 years, with 82% males, 53% had ischemic cardiomyopathy, and 45% were DT. The mean follow-up was 2.2 ± 2.1 years. In both BTT and DT cohorts, pre LVAD VAs were not associated with mortality after LVAD implantation (log-rank p=0.95 and p=0.089, respectively). In the BTT population, early post-LVAD VAs were not statistically associated with increased mortality (log rank p=0.072). In the DT patients, early post LVAD VAs were associated with a 67 % increase in the hazards rate of mortality on LVAD support (HR 1.67 [1.05-2.65], p=0.029). The final model was adjusted for type of cardiomyopathy, INTERMACS profile, glomerular filtration rate, post LVAD atrial fibrillation, age and cerebrovascular events.Conclusion: Early post-LVAD VA is common after LVAD implantation and is an independent predictor of mortality in the DT LVAD population.

A definitive dietary preparation recommendation is not possible based on literature on the achievement of myocardial suppression for diagnosis of cardiac sarcoidosis (CS) with (18)F-FDG PET/CT. Our goal is to compare 3 different dietary preparations in achievement of the best myocardial suppression and CS diagnosis. Methods: We retrospectively reviewed and compared 3 dietary preparations used at our institution. Three different diets were applied from March 2014 to December 2019: a 24-h ketogenic diet with overnight fasting (n = 94); 18-h fasting (n = 44); and 72-h daytime ketogenic diet with 3-d overnight fasting (n = 98). The interpretation of initial reports was recorded, and an independent radiologist (observer) retrospectively reevaluated each case regarding CS diagnosis (negative, positive, indeterminant) and myocardial suppression (complete, failed, partial). Interobserver agreement was analyzed. We measured SUVmax from blood pool, liver, and the most suppressed normal myocardium. Results: We identified superior myocardial suppression with the 72-h preparation, indicated by higher blood pool-to-myocardium and liver-to-myocardium ratios (P < 0.001). Myocardial suppression rates for the 72-h ketogenic diet, 24-h ketogenic diet, and 18-h fasting preparations were as follows: complete myocardial suppression, 96.9%, 68.1%, and 52.3%, respectively; failed myocardial suppression, 0%, 23.4%, and 25%, respectively; and partial myocardial suppression, 3.1%, 8.5%, and 22.7%, respectively (P < 0.001). The 72-h preparation had significantly fewer indeterminant and positive examinations. CS diagnosis rates for 72-h ketogenic diet, 24-h ketogenic diet, and 18-h fasting preparations were negative, 82.7%, 52.1%, and 27.3%, respectively; indeterminant, 2.0%, 24.5%, and 40.9%, respectively; and positive, 15.3%, 23.4%, and 31.8%, respectively (P < 0.001). A high agreement was present with the observer and the report (κ = 0.88). Conclusion: A 72-h daytime ketogenic diet with 3-d overnight fasting achieved substantially superior myocardial suppression versus a 24-h ketogenic diet with overnight fasting and an 18 h-fasting using (18)F-FDG PET/CT. This 72-h preparation results in significantly fewer indeterminant and potentially false-positive CS results.

Assess the association between digoxin use and gastrointestinal bleeding (GIB) in a multicenter continuous flow left ventricular assist device (LVAD) cohort.Patients implanted with continuous flow LVADs with data on GIB and digoxin use from two centers were included in the analysis (n = 649). GIB events were captured up to 2 years of follow-up. Digoxin use was defined as digoxin prescribed at discharge or within the first 3 months after LVAD implantation. A negative binomial regression model was performed to determine the association between digoxin use and number of GIB events over the follow-up period.Mean age of the cohort was 57 years (±14) and 45% (293/649) were bridge to transplant (BTT). Digoxin was prescribed in 33% of patients. Digoxin use was associated with an unadjusted 32% reduction in the incidence of rate of all cause GIB (IRR 0.68, 95% CI 0.46-0.99, p = 0.049). After adjusting for age, sex, Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile, renal function, and implanting center there was still a 34% reduction in the incidence rate (IRR 0.67, 95% CI 0.45-0.99, p = 0.048). When limiting the analysis to those with likely arteriovenous malformation associated GIB, the association strengthened (unadjusted: IRR 0.48, 95 % CI 0.26-0.89, p = 0.02, adjusted: IRR 0.47, 95 % CI 0.25-0.9, p = 0.022).In this multicenter study, inclusive of contemporary devices, digoxin use was associated with reduced GIB events. Prospective data will be required to confirm this association.

Background Adriamycin-associated cardiomyopathy (ACM) can lead to end-stage heart failure requiring advanced heart failure therapies. Objectives This study sought to provide post–cardiac transplant survival data in patients with ACM in the contemporary era of mechanical circulatory support and cardiac transplantation. Methods Adults (≥18 years of age) who underwent first-time, single-organ heart transplantation were identified from the United Network for Organ Sharing between October 18, 2008, and October 18, 2018. Cardiomyopathy subtypes that could have been supported with a left ventricular assist device (LVAD) including ACM, dilated cardiomyopathy (DCM), and ischemic cardiomyopathy (ICM) were included. A multivariable Cox regression analysis was performed to determine the association between cardiomyopathy subtype and post–cardiac transplant survival. Results This analysis included 18,270 patients (357 with ACM; 10,662 with DCM; and 7,251 with ICM). Heart transplant recipients with ACM were younger, included more women, and had higher pulmonary vascular resistance at the time of listing. Patients with ACM had a lower percentage of durable LVADs at the time of transplant across all years of the study period. Patients with ACM did not experience an increase in post–cardiac transplant mortality compared to those with DCM (adjusted hazard ratio: 0.96; 95% confidence interval: 0.79 to 1.40; p = 0.764) or ICM (adjusted hazard ratio: 0.85; 95% confidence interval: 0.6 to 1.2; p = 0.304). Conclusions Patients with ACM who received heart transplants between 2008 and 2018 had similar post–cardiac transplant survival to those with dilated and ischemic cardiomyopathy. Bridge-to-transplant LVAD use remains lower compared to other cardiomyopathy subtypes., Central Illustration

BACKGROUND: This study evaluates the impact of the 2018 allocation policy change on outcomes of orthotopic heart transplantation (OHT) in patients bridged with intra-aortic balloon pumps (IABPs). METHODS: Adult (≥18 years) patients undergoing OHT between 2013 and 2019 who were bridged with an IABP were stratified based on temporal relation to the policy change. Univariate analysis was used to compare baseline characteristics and postoperative outcomes. Multivariate Cox regression analysis was used to estimate risk-adjusted predictors of post-transplant mortality. RESULTS: A total of 1342 (8.6%) OHT patients were bridged with an IABP during the study period. Rates of bridging with IABP to OHT increased significantly after the policy change (7.0% versus 24.9%, P

Early readmission (within 30 days) after left ventricular assist device (LVAD) implantation might be a marker for increased mortality. We retrospectively reviewed the records of 277 adults who underwent continuous-flow LVAD implantation from 2005 through 2015 at our institution. The baseline characteristics of patients who were (versus were not) readmitted within 30 days after LVAD implantation were compared. To assess the impact of 30 day readmission on long-term survival, we used multivariate Cox regression. We also compared the cardiac transplant rate between the two groups. Of the 277 patients, 217 (78.3%) underwent LVAD implantation as a bridge-to-transplant; 76 (27.4%) of the 277 were readmitted within 30 days. The most common reason for readmission was volume overload (23.6%), followed by gastrointestinal bleeding (15.8%). Male gender, previous smoking, a higher baseline creatinine level, higher Model for End Stage Liver Disease Excluding INR (MELD-XI) score, and postoperative gastrointestinal bleeding or stroke were each associated with 30 day readmission. In our final multivariate model, increased mortality was also associated with 30 day readmission (hazard ratio, 1.60; 95% confidence interval, 1.1-2.5). Among the 217 bridge-to-transplant patients, the cardiac transplant rate was similar between the two groups: 18.7 transplants per patient-year among those who were readmitted within 30 days versus 19.7 transplants per patient-year among those who were not (p = 0.26). Among our study patients, 30 day readmission after LVAD implantation was frequent and was associated with increased mortality. It is currently unclear whether the general health of those patients was a factor and whether efforts to reduce 30 day readmission would favorably affect longer-term patient outcomes.

Background Sarcoidosis is a systemic granulomatous disease of unknown etiology. Clinical cohort studies of different populations are important to understand the high variability in clinical presentation and disease course of sarcoidosis. The aim of the study is to evaluate clinical characteristics, including organ involvement, pulmonary function tests, and laboratory parameters, in a sarcoidosis cohort at the University of Minnesota. We compare the organ system involvement of this cohort with other available cohorts. Methods We conducted a retrospective data collection and analysis of 187 subjects with biopsy-proven sarcoidosis seen at a tertiary center. Organ system involvement was determined using the WASOG sarcoidosis organ assessment instrument. Clinical phenotype groups were classified using the Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis criteria. Results Mean subject age at diagnosis was 45.8 ± 12.4, with a higher proportion of males (55.1%), and a higher proportion of blacks (17.1%) compared to the racial distribution of Minnesota residents (5.95%). The majority (71.1%) of subjects required anti-inflammatory therapy for at least 1 month. Compared to the A Case Control Etiologic Study of Sarcoidosis cohort, there was a higher frequency of extra-thoracic lymph node (34.2% vs. 15.2%), eye (20.9% vs. 11.8%), liver (17.6% vs. 11.5%), spleen (20.9% vs. 6.7%), musculoskeletal (9.6% vs. 0.5%), and cardiac (10.7% vs. 2.3%) involvement in our cohort. A multisystem disease with at least five different organs involved was identified in 13.4% of subjects. A restrictive physiological pattern was observed in 21.6% of subjects, followed by an obstructive pattern in 17.3% and mixed obstructive and restrictive pattern in 2.2%. Almost half (49.2%) were Scadding stages II/III. Commonly employed disease activity markers, including soluble interleukin-2 receptor and angiotensin-converting enzyme, did not differ between treated and untreated groups. Conclusions This cohort features a relatively high frequency of high-risk sarcoidosis phenotypes including cardiac and multiorgan disease. Commonly-utilized serum biomarkers do not identify subpopulations that require or do better with treatment. Findings from this study further highlight the high-variability nature of sarcoidosis and the need for a more reliable biomarker to predict and measure disease severity and outcomes for better clinical management of sarcoidosis patients.

Myocardial fibrosis identified by apical core pathology at the time of left ventricular assist device (LVAD) implantation may add information regarding myocardial recovery potential. In this analysis, we report the prevalence of myocardial fibrosis by cardiomyopathy type and its association with other known markers of left ventricular recovery. Left ventricular assist device core pathology was reviewed on 332 patients who underwent LVAD implantation at a single institution between 2005 and 2016. Baseline clinical and echocardiographic characteristics were compared among patients with and without myocardial fibrosis by cardiomyopathy type. Among the 332 LVAD core specimens, myocardial fibrosis was present in 79%. Myocardial fibrosis was more common in ischemic than in nonischemic patients (90% vs. 66%; p < 0.001). Patients with fibrosis were older than those without (58 ± 12 vs. 55 ± 19; p < 0.05). Among the nonischemic cardiomyopathy cases, those with fibrosis were more likely to have an implantable cardioverter defibrillator (ICD) 81% and to be diabetic 81%. Fibrosis was not associated with left ventricular end-diastolic diameter (LVEDD), creatinine, or N-terminal prohormone of brain natriuretic peptide (NT-pro BNP). Myocardial fibrosis by apical core biopsy correlated with several known markers of left ventricular recovery including cardiomyopathy type, age, and presence of an ICD. In nonischemic cardiomyopathy patients, the degree of myocardial fibrosis may add information regarding recovery potential.

Background Left ventricular assist device (LVAD) related complications have the potential to disqualify patients for heart transplantation. We sought to determine whether LVAD support was associated with increased rates of delisting due to medical unsuitability or clinical deterioration. Methods The analysis included adult candidates listed for first-time heart transplantation in the UNOS registry in the contemporary, continuous flow (CF)- LVAD era (2010–2016). The exposure variable was LVAD support on the waitlist. The primary outcome was time to delisting due to medical unsuitability or clinical deterioration. As cardiac transplantation and death represent competing risks in this study, a Fine-Gray cox regression analysis was performed. Results Data on 16,913 patients listed for heart transplant were analyzed. During a median follow up of 150 days, 1206 (7.1%) patients died, 10,083 (60%) were transplanted, and 1224 (7.2%) were delisted due to medical unsuitability or clinical deterioration. Presence of a LVAD at listing was associated with a reduced rate (hazard) of delisting both in the adjusted and unadjusted models (unadjusted HR 0.63, 95% CI 0.55–0.73, adjusted HR 0.78, 95% CI 0.67–0.90). Delayed LVAD while on the list was not associated with reduced rates of delisting (adjusted HR 0.91, 95% CI 0.79–1.1). Conclusions Continuous flow left ventricular assist device support was protective against delisting in this UNOS analysis. These data would suggest that despite the adverse event rate of mechanical support, improving cardiac output may be important to preserving the overall health of the potential cardiac transplant recipient.

Background Primary outcomes analysis of the Multicenter Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3 (MOMENTUM 3) trial short-term cohort demonstrated a higher survival rate free of debilitating stroke and reoperation to replace/remove the device (primary end-point) in patients receiving the HeartMate 3 (HM3) compared with the HeartMate (HMII). In this study we sought to evaluate the individual and interactive effects of pre-specified patient subgroups (age, sex, race, therapeutic intent [bridge to transplant/bridge to candidacy/destination therapy] and severity of illness) on primary end-point outcomes in MOMENTUM 3 patients implanted with HM3 and HMII devices. Methods Cox proportional hazard models were used to analyze patients enrolled in the “as-treated cohort” ( n = 289) of the MOMENTUM 3 trial to: (1) determine interaction of various subgroups on primary end-point outcomes; and (2) identify independent variables associated with primary end-point success. Results Baseline characteristics were well balanced among HM3 ( n = 151) and HMII ( n = 138) cohorts. No significant interaction between the sub-groups on primary end-point outcomes was observed. Cox multivariable modeling identified age (≤65 years vs >65 years, hazard ratio 0.42 [95% confidence interval 0.22 to 0.78], p = 0.006]) and pump type (HM3 vs HMII, hazard ratio 0.53 [95% confidence interval 0.30 to 0.96], p = 0.034) to be independent predictors of primary outcomes success. After adjusting for age, no significant impact of sex, race, therapeutic intent and INTERMACS profiles on primary outcomes were observed. Conclusions This analysis of MOMENTUM 3 suggests that younger age (≤65 years) at implant and pump choice are associated with a greater likelihood of primary end-point success. These findings further suggest that characterization of therapeutic intent into discrete bridge-to-transplant and destination therapy categories offers no clear clinical advantage, and should ideally be abandoned.

Aims Undetected atrial fibrillation (AF) may be common in the heart failure with preserved ejection fraction (HFpEF) population, and failure to detect this may lead to the missing of opportunities to prevent associated subclinical cerebral infarctions (SCIs) and cognitive decline. Methods and results We studied 1527 participants in the Atherosclerosis Risk in Communities (ARIC) Study, who underwent echocardiography, brain magnetic resonance imaging (MRI) and detailed cognitive assessment during 2011–13. Prevalences of SCI as detected by brain MRI were compared among the following groups: participants with no HFpEF/no AF; those with no HFpEF/AF; those with HFpEF/no AF, and those with HFpEF/AF. Cognitive scores were also compared. Prevalences of HFpEF and AF in this sample were 13.2% and 5.7%, respectively. Participants with HFpEF but no prior diagnosis of AF had a high prevalence of SCI by brain MRI (29.3%), which was similar to those in the no HFpEF/AF (24.5%) and HFpEF/AF (23.5%) groups, but higher than that in the no HFpEF/no AF subjects (17.3%). The odds of having SCI were higher in participants with HFpEF/no AF than in the no HFpEF/no AF group even after adjustment for potential confounders (odds ratio 1.56, 95% confidence interval 1.06–2.30). Individuals with HFpEF and SCI had lower cognitive scores than the reference (no HFpEF/no SCI) and HFpEF/no SCI groups. Conclusions Subclinical cerebral infarctions were prevalent in subjects in the ARIC cohort with HFpEF and no prior AF diagnosis and are associated with measurable cognitive deficits. Although other sources of emboli may be possible, these data suggest that paroxysmal AF may be underdiagnosed in this population. There may be a role for earlier anticoagulation in patients with HFpEF.

Purpose Cardiopulmonary stress testing (CPX) is widely used to evaluate patients with end stage heart failure who may benefit from advanced therapies, such as durable left ventricular assist devices (LVAD). A hypotensive systolic blood pressure response on CPX may identify a subpopulation with the highest risk physiology. We sought to evaluate long term outcomes among LVAD recipients with a pre-implantation hypotensive response. Methods This was a retrospective single center study using consecutive patients implanted with a continuous flow LVAD between 1/2011 and 1/2019 at our Institution. Patients with CPX performed within 12 months before implantation were included. Hypotensive response was defined as a peak exercise systolic blood pressure lower than the resting systolic blood pressure. The primary outcome was 1-year mortality. Multivariable cox regression analysis was performed to evaluate the relationship between hypotensive exercise blood pressure response and mortality. Multivariate linear regression analysis was used to determine pre-implant variables and mortality. Results 313 patients were enrolled in the study and 123 were identified to meet our inclusion criteria. The mean age was 60.1 years, 58% had ischemic cardiomyopathy and 85% were classified as INTERMACS 3-5. 54 patients had a hypotensive response on CPX (44%). A total of 14 patients died at 1 year, 10 from the hypotensive cohort (p=0.043), hazard ratio 3.54 with 95% CI (1.1, 11.3, p=0.033). Post-implantation ICU and overall hospital length of stay were similar to the group with normal blood pressure response. There was also no significant difference in post-operative complications and the risk of re-hospitalization at 1 month, 6 months and 1 year. Conclusion Hypotensive blood pressure response on the CPX performed pre-LVAD implantation is independently associated with increased 1-year mortality. Additional studies are needed to further characterize this high-risk patient population and to identify strategies to improve survival rates.