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Importance: Greater splanchnic nerve ablation may improve hemodynamics in patients with heart failure and preserved ejection fraction (HFpEF)., Objective: To explore the feasibility and safety of endovascular right-sided splanchnic nerve ablation for volume management (SAVM)., Design, Setting, and Participants: This was a phase 2, double-blind, 1:1, sham-controlled, multicenter, randomized clinical trial conducted at 14 centers in the US and 1 center in the Republic of Georgia. Patients with HFpEF, left ventricular ejection fraction of 40% or greater, and invasively measured peak exercise pulmonary capillary wedge pressure (PCWP) of 25 mm Hg or greater were included. Study data were analyzed from May 2023 to June 2024., Intervention: SAVM vs sham control procedure., Main Outcomes and Measures: The primary efficacy end point was a reduction in legs-up and exercise PCWP at 1 month. The primary safety end point was serious device- or procedure-related adverse events at 1 month. Secondary efficacy end points included HF hospitalizations, changes in exercise function and health status through 12 months, and baseline to 1-month change in resting, legs-up, and 20-W exercise PCWP., Results: A total of 90 patients (median [range] age, 71 [47-90] years; 58 female [64.4%]) were randomized at 15 centers (44 SAVM vs 46 sham). There were no differences in adverse events between groups. The primary efficacy end point did not differ between SAVM or sham (mean between-group difference in PCWP, -0.03 mm Hg; 95% CI, -2.5 to 2.5 mm Hg; P = .95). There were also no differences in the secondary efficacy end points. There was no difference in the primary safety end point between the treatment (6.8% [3 of 44]) and sham (2.2% [1 of 46]) groups (difference, 4.6%; 95% CI, -6.1% to 15.4%; P = .36). There was no difference in the incidence of orthostatic hypotension between the treatment (11.4% [5 of 44]) and sham (6.5% [3 of 46]) groups (difference, 4.9%; 95% CI, -9.2% to 18.8%; P = .48)., Conclusions and Relevance: Results show that SAVM was safe and technically feasible, but it did not reduce exercise PCWP at 1 month or improve clinical outcomes at 12 months in a broad population of patients with HFpEF., Trial Registration: ClinicalTrials.gov Identifier: NCT04592445.

Background: Monitoring supine pulmonary artery pressures to guide heart failure (HF) management has reduced HF hospitalizations in select patients., Objectives: The purpose of this study was to evaluate the effect of managing seated mean pulmonary artery pressure (mPAP) with the Cordella Pulmonary Artery sensor on outcomes in patients with HF., Methods: Following GUIDE-HF (Hemodynamic-GUIDEd Management of Heart Failure Trial), with U.S. Food and Drug Administration input, PROACTIVE-HF (A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial) was changed from a randomized to a single-arm, open label trial, conducted at 75 centers in the USA and Europe. Eligible patients had chronic HF with NYHA functional class III symptoms, irrespective of the ejection fraction, and recent HF hospitalization and/or elevated natriuretic peptides. The primary effectiveness endpoint at 6 months required the HF hospitalization or all-cause mortality rate to be lower than a performance goal of 0.43 events/patient, established from previous hemodynamic monitoring trials. Primary safety endpoints at 6 months were freedom from device- or system-related complications or pressure sensor failure., Results: Between February 7, 2020, and March 31, 2023, 456 patients were successfully implanted in modified intent-to-treat cohort. The 6-month event rate was 0.15 (95% CI: 0.12-0.20) which was significantly lower than performance goal (0.15 vs 0.43; P < 0.0001). Freedom from device- or system-related complications was 99.2% and freedom from sensor failure was 99.8% through 6 months., Conclusions: Remote management of seated mPAP is safe and results in a low rate of HF hospitalizations and mortality. These results support the use of seated mPAP monitoring and extend the growing body of evidence that pulmonary artery pressure-guided management improves outcomes in heart failure. (Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial [PROACTIVE-HF]; NCT04089059)., Competing Interests: Funding Support and Author Disclosures This work was supported by Endotronix Inc. Drs Miranda, Shah, Macaluso, and Hickey were on the Eligibility Committee of PROACTIVE-HF. Prof Sharif is funded by the Science Foundation Ireland SFI 17/RI/5353. Drs Hiivala, Owens, Sauerland, and Forouzan are employees of Endotronix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: Patients with heart failure and mildly reduced or preserved ejection fraction have limited therapeutic options. The ALT-FLOW Early Feasibility Study evaluated safety, haemodynamics and outcomes for the APTURE transcatheter shunt system, a novel left atrium to coronary sinus shunt in these patients., Methods and Results: Safety and shunt implantation success was evaluated for all 116 enrolled patients. An analysis population of implanted patients with a left ventricular ejection fraction (LVEF) >40% (n = 95) was chosen to assess efficacy via paired comparison between baseline and follow-up haemodynamic (3 and 6 months), and echocardiographic, clinical and functional outcomes (6 months and 1 year). Health status and quality of life outcomes were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS). The primary safety endpoint, major adverse cardiac, cerebral, and renal events, and reintervention through 30 days, occurred in 3/116 patients (2.6%). All implanted shunts were patent at 1 year. In patients with LVEF >40%, the mean (95% confidence interval) reduction in exercise pulmonary capillary wedge pressure (PCWP) at 20 W was -5.7 (-8.6, -2.9) mmHg at 6 months (p < 0.001). At baseline, 8% had New York Heart Association class I-II status and improved to 68% at 1 year (p < 0.001). KCCQ-OSS at baseline was 39 (35, 43) and improved at 6 months and 1 year by 25 (20-30) and 27 (22-32) points, respectively (both p < 0.0001). No adverse changes in haemodynamic and echocardiographic indices of right heart function were observed at 1 year. Overall, the reduction in PCWP at 20 W and improvement in KCCQ-OSS in multiple subgroups were consistent with those observed for the entire population., Conclusions: In patients with heart failure and LVEF >40%, the APTURE shunt demonstrated an acceptable safety profile with significant sustained improvements in haemodynamic and patient-centred outcomes, underscoring the need for further evaluation of the APTURE shunt in a randomized trial., (© 2024 European Society of Cardiology.)

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., Competing Interests: Disclosures CSL reports grants or contracts from NIH and QED Medical Research Foundation; JS reports grants from Natera; BR, PCORI, UCSD) and consulting fees from LAA, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis; JS reports from Medtronic; JL reports from Abbott, AstraZeneca, Alleviant, Boston Scientific, Merck, CVRx, VWave, and Edwards; EDA reports from Abiomed, Novartis, Abbott, Ionis Pharmaceuticals, Sana Biotechnology, Medtronic, Lexeo Pharmaceuticals, and Cytokinetics; KLG reports payment or honoraria from Amgen; JJT reports CareDx, Medtronic, and Paragonix; MSK reports from Medtronic; BR reports TEACH faculty development program; KLG reports AHA, payment for expert testimony (EDA: Astra Zeneca), meeting/travel support; MSK reports Abbott; KLG: ISHLT, AHA); Data Safety Monitoring Board or Advisory Board; JJT reports from CareDx, Medtronic, Abiomed, Takeda, Abbott; MSK reports Medtronic; JKK reports Carmat and Xeltis clinical trials), leadership or fiduciary role (EDA Papillon Therapeutics, ResQ Pharmaceuticals); JKK reports ISHLT Research Foundation, International Society for Heart & Lung Transplantation; KLG reports ISHLT; LAA reports being associate editor of Circulation: Heart Failure; DC reports being President-elect, PROMIS Health Organization; JKK reports being Director of the Data Center for STS-Intermacs Registry for Mechanical Circulatory Support., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Pulmonary hypertension (PH) is life-threatening, and often diagnosed late in its course. We aimed to evaluate if a deep learning approach using electrocardiogram (ECG) data alone can detect PH and clinically important subtypes. We asked: does an automated deep learning approach to ECG interpretation detect PH and its clinically important subtypes?, Methods and Results: Adults with right heart catheterization or an echocardiogram within 90 days of an ECG at the University of California, San Francisco (2012-2019) were retrospectively identified as PH or non-PH. A deep convolutional neural network was trained on patients' 12-lead ECG voltage data. Patients were divided into training, development, and test sets in a ratio of 7:1:2. Overall, 5016 PH and 19,454 patients without PH were used in the study. The mean age at the time of ECG was 62.29 ± 17.58 years and 49.88% were female. The mean interval between ECG and right heart catheterization or echocardiogram was 3.66 and 2.23 days for patients with PH and patients without PH, respectively. In the test dataset, the model achieved an area under the receiver operating characteristic curve, sensitivity, and specificity, respectively of 0.89, 0.79, and 0.84 to detect PH; 0.91, 0.83, and 0.84 to detect precapillary PH; 0.88, 0.81, and 0.81 to detect pulmonary arterial hypertension, and 0.80, 0.73, and 0.76 to detect group 3 PH. We additionally applied the trained model on ECGs from participants in the test dataset that were obtained from up to 2 years before diagnosis of PH; the area under the receiver operating characteristic curve was 0.79 or greater., Conclusions: A deep learning ECG algorithm can detect PH and PH subtypes around the time of diagnosis and can detect PH using ECGs that were done up to 2 years before right heart catheterization/echocardiogram diagnosis. This approach has the potential to decrease diagnostic delays in PH., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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., Competing Interests: Conflicts of Interest Omid Forouzan, Nicholas J. Hiivala, Andrea Sauerland, and Katrin Leadley are employees of Endotronix. All other authors report no financial relationships or conflicts of interest regarding the content herein., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: The Cordella pulmonary artery (PA) pressure sensor (Endotronix, Inc) is an investigational, wireless, microelectromechanical system (MEMS) sensor that allows remote monitoring of PA pressures. Understanding the implantation procedure and technical nuances is key to safe, efficient, and effective implantation to allow for successful use of the PA pressure sensor over the long term. We provide a summary of the implantation procedure and present a series of cases detailing the Cordella PA pressure sensor implantation in the United States and Europe.

Background: Patients with heart failure (HF) and reduced ejection fraction suffer from a relapsing and remitting disease course, where early treatment changes may improve outcomes. We assessed the clinical integration and safety of the HeartLogic multisensor index and alerts in HF care., Methods: The Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) study enrolled 200 patients with HF and reduced ejection fraction (<35%), New York Heart Association functional class II-III symptoms, implanted with a cardiac resynchronization therapy-defibrillator or and implantable cardioverter defibrillator, who had either a hospitalization for HF within 12 months or unscheduled visit for HF exacerbation within 90 days or an elevated natriuretic peptide concentration (brain natriuretic peptide [BNP] of ≥150 pg/mL or N-terminal pro-BNP [NT-proBNP] of ≥600 pg/mL). This phase included the development of an alert management guide and evaluated changes in medical treatment, natriuretic peptide levels, and safety., Results: The mean age of participants was 67 years, 68% were men, 81% were White, and 61% had a HF hospitalization in prior 12 months. During follow-up, there were 585 alert cases with an average of 1.76 alert cases per patient-year. HF medications were augmented during 74% of the alert cases. HF treatment augmentation within 2 weeks from an initial alert was associated with more rapid recovery of the HeartLogic Index. Five serious adverse events (0.015 per patient-year) occurred in relation to alert-prompted medication change. NTproBNP levels decreased from median of 1316 pg/mL at baseline to 743 pg/mL at 12 months (P < .001)., Conclusions: HeartLogic alert management was safely implemented in HF care and may optimize HF management. This phase supports further evaluation in larger studies., Trial Registration: ClinicalTrials.gov (NCT03237858)., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Arrhythmogenic right ventricular cardiomyopathy (ARVC) is an important cause of sudden cardiac death in young people and athletes. To date, no treatment has proven to slow the progression of the disease. Preload reducing agents such as nitrates and diuretics have shown promising results in preventing training-induced development of ARVC in a murine model., Objective: The purpose of this study was to describe our experience with preload reducing therapy in patients with ARVC and symptomatic right ventricular (RV) dysfunction., Methods: We performed retrospective chart review of prospectively collected registry data and included 20 patients with definite ARVC who had serial echocardiographic measurements and an implantable cardioverter-defibrillator. Six of the 20 patients with RV end-diastolic area (RVEDA) above median (>25 cm 2 ) and New York Heart Association functional class II-IV symptoms were successfully treated with long-term isosorbide dinitrate 5-40 mg tid (at maximum tolerated dose) and hydrochlorothiazide-spironolactone 25-25 mg daily. The main outcomes of interest were RVEDA, RV fractional area change (FAC), and RV outflow tract measurements. Generalized estimating equations with repeated measures were used to identify the association between preload reducing agents and echocardiographic structural progression., Results: Patients who received preload reducing agents (n = 6) were older and had larger RVs with lower FAC at baseline. However, treatment with preload reducing agents was associated with less RVEDA enlargement during mean 3.3 (range 1-6.7) years of treatment in multivariate analysis (% change in RVEDA associated with treatment -7.71; 95% confidence interval -13.29 to -2.13; P = .007)., Conclusion: Preload reducing agents show promising results in slowing RV enlargement in patients with ARVC and show possible disease-modifying potential., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Objective: Pregnancy requires a complex physiological adaptation of the maternal cardiovascular system, which is disrupted in women with pregnancies complicated by preeclampsia, putting them at higher risk of future cardiovascular events. The measurement of body movements in response to cardiac ejection via ballistocardiogram (BCG) can be used to assess cardiovascular hemodynamics noninvasively in women with preeclampsia. Methods: Using a previously validated, modified weighing scale for assessment of cardiovascular hemodynamics through measurement of BCG and electrocardiogram (ECG) signals, we collected serial measurements throughout pregnancy and postpartum and analyzed data in 30 women with preeclampsia and 23 normotensive controls. Using BCG and ECG signals, we extracted measures of cardiac output, J-wave amplitude × heart rate (J-amp × HR). Mixed-effect models with repeated measures were used to compare J-amp × HRs between groups at different time points in pregnancy and postpartum. Results: In normotensive controls, the J-amp × HR was significantly lower early postpartum (E-PP) compared with the second trimester (T2; p  = 0.016) and third trimester (T3; p  = 0.001). Women with preeclampsia had a significantly lower J-amp × HR compared with normotensive controls during the first trimester (T1; p  = 0.026). In the preeclampsia group, there was a trend toward an increase in J-amp × HR from T1 to T2 and then a drop in J-amp × HR at T3 and further drop at E-PP. Conclusions: We observe cardiac hemodynamic changes consistent with those reported using well-validated tools. In pregnancies complicated by preeclampsia, the maximal force of contraction is lower, suggesting lower cardiac output and a trend in hemodynamics consistent with the hyperdynamic disease model of preeclampsia., Competing Interests: O.Q., M.H.S., S.B., S.D., D.T., J.H., M.E., S.R., J.G.V., and L.K. have no competing financial interests. O.T.I. is a Scientific Advisor for Physiowave, Inc., (© Odayme Quesada et al., 2021; Published by Mary Ann Liebert, Inc.)

Background: African American and Hispanic postmenopausal women have the highest risk for heart failure compared with other races, but heart failure prevalence is lower than expected in some national cohorts. It is unknown whether psychosocial factors are associated with lower risk of incident heart failure hospitalization among high-risk postmenopausal minority women., Methods and Results: Using the Women's Health Initiative Study, African American and US Hispanic women were classified as high-risk for incident heart failure hospitalization with 1 or more traditional heart failure risk factors and the highest tertile heart failure genetic risk scores. Positive psychosocial factors (optimism, social support, religion) and negative psychosocial factors (living alone, social strain, depressive symptoms) were measured using validated survey instruments at baseline. Adjusted subdistribution hazard ratios of developing heart failure hospitalization were determined with death as a competing risk. Positive deviance indicated not developing incident heart failure hospitalization with 1 or more risk factors and the highest tertile for genetic risk. Among 7986 African American women (mean follow-up of 16 years), 27.0% demonstrated positive deviance. Among high-risk African American women, optimism was associated with modestly reduced risk of heart failure hospitalization (subdistribution hazard ratio 0.94, 95% confidence interval 0.91-0.99), and social strain was associated with modestly increased risk of heart failure hospitalization (subdistribution hazard ratio 1.07, 95% confidence interval 1.02-1.12) in the initial models; however, no psychosocial factors were associated with heart failure hospitalization in fully adjusted analyses. Among 3341 Hispanic women, 25.1% demonstrated positive deviance. Among high-risk Hispanic women, living alone was associated with increased risk of heart failure hospitalization (subdistribution hazard ratio 1.97, 95% confidence interval 1.06-3.63) in unadjusted analyses; however, no psychosocial factors were associated with heart failure hospitalization in fully adjusted analyses., Conclusions: Among postmenopausal African American and Hispanic women, a significant proportion remained free from heart failure hospitalization despite having the highest genetic risk profile and 1 or more traditional risk factors. No observed psychosocial factors were associated with incident heart failure hospitalization in high-risk African Americans and Hispanics. Additional investigation is needed to understand protective factors among high-risk African American and Hispanic women., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Heart failure (HF) and breast cancer are 2 of the leading causes of death in postmenopausal women. The temporal association between HF and breast cancer in postmenopausal women has not been described., Objectives: This study sought to examine the temporal association between HF and breast cancer., Methods: Postmenopausal women within the WHI (Women's Health Initiative) cohort were studied. All prevalent HF and prevalent breast cancer at enrollment were self-reported. Incident hospitalized HF and breast cancer diagnoses were adjudicated through 2017., Results: Among a cohort of 44,174 women (mean age 63 ± 7 years), 2,188 developed incident invasive breast cancer and 2,416 developed incident hospitalized HF over a median follow-up of 14 and 15 years, respectively. When compared with a breast cancer- and HF-free cohort, there was no association between prevalent HF and incident invasive breast cancer and similarly, there was no association between prevalent breast cancer and incident hospitalized HF. Across the entire cohort, the median survival after incident hospitalized HF was worse compared with an incident invasive breast cancer diagnosis (5 and 19 years, respectively). In women with incident invasive breast cancer, prevalent HF was associated with an increased risk of mortality (hazard ratio: 2.28; 95% confidence interval: 1.31 to 3.95). In women with incident hospitalized HF, prevalent breast cancer was associated with an increased risk of mortality (hazard ratio: 1.66; 95% confidence interval: 1.03 to 2.68). Cause of death after incident HF was different only in women with prevalent and interim breast cancer compared with those without prevalent and interim breast cancer., Conclusions: In postmenopausal women, prevalent HF was not associated with a higher incidence of breast cancer and vice versa. However, the presence of incident invasive breast cancer or incident HF in those with prevalent HF or prevalent breast cancer, respectively, was associated with increased mortality., Competing Interests: Dr. Nohria has received research support from Amgen, Inc.; and has consulted for Takeda Oncology. Dr. Fonarow has consulted for Abbott, Amgen, Bayer, Janssen, Novartis, and Medtronic. Dr. Chlebowski has consulted for Novartis, AstraZeneca, Genentech, Merck, and Immunomedics; and has received honorarium from Novartis and AstraZeneca. Dr. Mohammed serves on the Advisory Board for Pfizer; and has received research support from CardioCell, Abbott, Actelion, Corvia, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2020 The Authors.)

Background: To estimate oxygen uptake (VO 2 ) from cardiopulmonary exercise testing (CPX) using simultaneously recorded seismocardiogram (SCG) and electrocardiogram (ECG) signals captured with a small wearable patch. CPX is an important risk stratification tool for patients with heart failure (HF) owing to the prognostic value of the features derived from the gas exchange variables such as VO 2 . However, CPX requires specialized equipment, as well as trained professionals to conduct the study., Methods and Results: We have conducted a total of 68 CPX tests on 59 patients with HF with reduced ejection fraction (31% women, mean age 55 ± 13 years, ejection fraction 0.27 ± 0.11, 79% stage C). The patients were fitted with a wearable sensing patch and underwent treadmill CPX. We divided the dataset into a training-testing set (n = 44) and a separate validation set (n = 24). We developed globalized (population) regression models to estimate VO 2 from the SCG and ECG signals measured continuously with the patch. We further classified the patients as stage D or C using the SCG and ECG features to assess the ability to detect clinical state from the wearable patch measurements alone. We developed the regression and classification model with cross-validation on the training-testing set and validated the models on the validation set. The regression model to estimate VO 2 from the wearable features yielded a moderate correlation (R 2 of 0.64) with a root mean square error of 2.51 ± 1.12 mL · kg -1 · min -1 on the training-testing set, whereas R 2 and root mean square error on the validation set were 0.76 and 2.28 ± 0.93 mL · kg -1 · min -1 , respectively. Furthermore, the classification of clinical state yielded accuracy, sensitivity, specificity, and an area under the receiver operating characteristic curve values of 0.84, 0.91, 0.64, and 0.74, respectively, for the training-testing set, and 0.83, 0.86, 0.67, and 0.92, respectively, for the validation set., Conclusions: Wearable SCG and ECG can assess CPX VO 2 and thereby classify clinical status for patients with HF. These methods may provide value in the risk stratification of patients with HF by tracking cardiopulmonary parameters and clinical status outside of specialized settings, potentially allowing for more frequent assessments to be performed during longitudinal monitoring and treatment., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: Left ventricular assist devices (LVADs) fail in up to 10% of patients due to the development of pump thrombosis. Remote monitoring of patients with LVADs can enable early detection and, subsequently, treatment and prevention of pump thrombosis. We assessed whether acoustical signals measured on the chest of patients with LVADs, combined with machine learning algorithms, can be used for detecting pump thrombosis., Methods: 13 centrifugal pump (HVAD) recipients were enrolled in the study. When hospitalized for suspected pump thrombosis, clinical data and acoustical recordings were obtained at admission, prior to and after administration of thrombolytic therapy, and every 24 hours until laboratory and pump parameters normalized. First, we selected the most important features among our feature set using LDH-based correlation analysis. Then using these features, we trained a logistic regression model and determined our decision threshold to differentiate between thrombosis and non-thrombosis episodes., Results: Accuracy, sensitivity and precision were calculated to be 88.9%, 90.9% and 83.3%, respectively. When tested on the post-thrombolysis data, our algorithm suggested possible pump abnormalities that were not identified by the reference pump power or biomarker abnormalities., Significance: We showed that the acoustical signatures of LVADs can be an index of mechanical deterioration and, when combined with machine learning algorithms, provide clinical decision support regarding the presence of pump thrombosis.

Advances in cancer therapeutics have dramatically improved the survival rate and quality of life in patients affected by various cancers, but have been accompanied by treatment-related cardiotoxicity, e.g. left ventricular (LV) dysfunction and/or overt heart failure (HF). Cardiologists thus need to assess cancer treatment-related cardiotoxic risks and have close followups for cancer survivors and patients undergoing cancer treatments using serial echocardiography exams and cardiovascular biomarkers testing. Unfortunately, the cost-prohibitive nature of echocardiography has made these routine follow-ups difficult and not accessible to the growing number of cancer survivors and patients undergoing cancer treatments. There is thus a need to develop a wearable system that can yield similar information at a minimal cost and can be used for remote monitoring of these patients. In this proof-of-concept study, we have investigated the use of wearable seismocardiography (SCG) to monitor LV function non-invasively for patients undergoing cancer treatment. A total of 12 subjects (six with normal LV relaxation, five with impaired relaxation and one with pseudo-normal relaxation) underwent routine echocardiography followed by a standard six-minute walk test. Wearable SCG and electrocardiogram signals were collected during the six-minute walk test and, later, the signal features were compared between subjects with normal and impaired LV relaxation. Pre-ejection period (PEP) from SCG decreased significantly (p < 0.05) during exercise for the subjects with impaired relaxation compared to the subjects with normal relaxation, and changes in PEP/LV ejection time (LVET) were also significantly different between these two groups (p < 0.05). These results suggest that wearable SCG may enable monitoring of patients undergoing cancer treatments by assessing cardiotoxicity.

Background: We assessed whether postmenopausal hormone therapy (HT) was associated with incident heart failure (HF) and its subtypes and examined whether there was a modifying effect of age on the associations., Methods and Results: Postmenopausal women aged 50-79 enrolled in the Women's Health Initiative HT trials were analyzed. The 16,486 women with a uterus were randomized to receive conjugated equine estrogens (CEE 0.625 mg/day) plus medroxyprogesterone acetate (MPA 2.5 mg/day) or placebo, and 10,739 women with prior hysterectomy were randomized to receive CEE (0.625 mg/day) alone or placebo. Incident HF was defined as the first HF hospitalization. HF with reduced ejection fraction (HFrEF) or preserved EF (HFpEF) was defined as EF < 50% or ≥ 50%. During the intervention phase, median follow-up was 5.6 years in the CEE-plus-MPA trial and 7.2 years in the CEE-alone trial. During the cumulative follow-up of 18.9 years, women randomized to HT vs placebo in the 2 combined trials had incidence rates of 3.90 vs 3.89 per 1000 person-years for total HF; 1.25 vs 1.40 per 1000 person-years for HFrEF, and 1.88 vs 1.79 per 1000 person-years for HFpEF, respectively. There were no significant effects of HT on the risk of total incident HF or its subtypes in either trial, and age at randomization did not significantly modify the results., Conclusions: Postmenopausal HT did not alter the risk of hospitalization for HF or its subtypes during the intervention or cumulative 18.9 years of follow-up, and results did not vary significantly by age at randomization., Trial Registration: clinicaltrials.gov Identifier: NCT0000611 https://clinicaltrials.gov/ct2/show/NCT00000611?cond=women%27s±health±initiative&rank=5., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background Long-term corticosteroid therapy is the standard of care for treatment of cardiac sarcoidosis (CS). The efficacy of long-term corticosteroid-sparing immunosuppression in CS is unknown. The goal of this study was to assess the efficacy of methotrexate with or without adalimumab for long-term disease suppression in CS, and to assess recurrence and adverse event rates after immunosuppression discontinuation. Methods and Results Retrospective chart review identified treatment-naive CS patients at a single academic medical center who received corticosteroid-sparing maintenance therapy. Demographics, cardiac uptake of 18-fluorodeoxyglucose, and adverse cardiac events were compared before and during treatment and between those with persistent or interrupted immunosuppression. Twenty-eight CS patients were followed for a mean 4.1 (SD 1.5) years. Twenty-five patients received 4 to 8 weeks of high-dose prednisone (>30 mg/day), followed by taper and maintenance therapy with methotrexate±low-dose prednisone (low-dose prednisone, <10 mg/day). Adalimumab was added in 19 patients with persistently active CS or in those with intolerance to methotrexate. Methotrexate±low-dose prednisone resulted in initial reduction (88%) or elimination (60%) of 18-fluorodeoxyglucose uptake, and patients receiving adalimumab-containing regimens experienced improved (84%) or resolved (63%) 18-fluorodeoxyglucose uptake. Radiologic relapse occurred in 8 of 9 patients after immunosuppression cessation, 4 patients on methotrexate-containing regimens, and in no patients on adalimumab-containing regimens. Conclusions Corticosteroid-sparing regimens containing methotrexate with or without adalimumab is an effective maintenance therapy in patients after an initial response is confirmed. Disease recurrence in patients on and off immunosuppression support need for ongoing radiologic surveillance regardless of immunosuppression regimen.

Background: Cardiovascular complications of pregnancy present an opportunity to assess risk for subsequent cardiovascular disease. We sought to determine whether peripartum cardiomyopathy and hypertensive disorder of pregnancy subtypes predict future myocardial infarction, heart failure or stroke independent of one another and of other risks such as gestational diabetes, preterm birth and intrauterine growth restriction., Methods and Results: The California Healthcare Cost and Utilization Project database was used to identify all hospitalised pregnancies from 2005 to 2009, with follow-up through 2011, for a retrospective cohort study. Pregnancies, exposures, covariates and outcomes were defined by International Classification of Diseases, Ninth Revision codes. Among 1.6 million pregnancies (mean age 28 years; median follow-up time to event excluding censoring 2.7 years), 558 cases of peripartum cardiomyopathy, 123 603 hypertensive disorders of pregnancy, 107 636 cases of gestational diabetes, 116 768 preterm births and 23 504 cases of intrauterine growth restriction were observed. Using multivariable Cox proportional hazards models, peripartum cardiomyopathy was independently associated with a 39.2-fold increase in heart failure (95% CI 30.0 to 51.9), resulting in ~1 additional hospitalisation per 1000 person-years. There was a 13.0-fold increase in myocardial infarction (95% CI 4.1 to 40.9) and a 7.7-fold increase in stroke (95% CI 2.4 to 24.0). Hypertensive disorders of pregnancy were associated with 1.4-fold (95% CI 1.0 to 2.0) to 7.6-fold (95% CI 5.4 to 10.7) higher risk of myocardial infarction, heart failure and stroke, resulting in a maximum of ~1 additional event per 1000 person-years. Gestational diabetes, preterm birth and intrauterine growth restriction had more modest associations., Conclusion: These findings support close monitoring of women with cardiovascular pregnancy complications for prevention of early cardiovascular events and study of mechanisms underlying their development., Competing Interests: Competing interests: None declared.

Objectives: This study prospectively examined physical activity levels and the incidence of heart failure (HF) in 137,303 women, ages 50 to 79 years, and examined a subset of 35,272 women who, it was determined, had HF with preserved ejection fraction (HFpEF) and HF with reduced EF (HFrEF)., Background: The role of physical activity in HF risk among older women is unclear, particularly for incidence of HFpEF or HFrEF., Methods: Women were free of HF and reported ability to walk at least 1 block without assistance at baseline. Recreational physical activity was self-reported. The study documented 2,523 cases of total HF, and 451 and 734 cases of HFrEF and HFpEF, respectively, during a mean 14-year follow-up., Results: After controlling for age, race, education, income, smoking, alcohol, hormone therapy, and hysterectomy status, compared with women who reported no physical activity (reference group), inverse associations were observed across incremental tertiles of total physical activity for overall HF (hazard ratio [HR]: Tertile 1 = 0.89, Tertile 2 = 0.74, Tertile 3 = 0.65; trend p < 0.001), HFpEF (HR: 0.93, 0.70, 0.68; p < 0.001), and HFrEF (HR: 0.81, 0.59, 0.68; p = 0.01). Additional controlling for potential mediating factors included attenuated time-varying coronary heart disease (CHD) (nonfatal myocardial infarction, coronary revascularization) diagnosis but did not eliminate the inverse associations. Walking, the most common form of physical activity in older women, was also inversely associated with HF risks (overall: 1.00, 0.98, 0.93, 0.72; p < 0.001; HFpEF: 1.00, 0.98, 0.87, 0.67; p < 0.001; HFrEF: 1.00, 0.75, 0.78, 0.67; p = 0.01). Associations between total physical activity and HF were consistent across subgroups, defined by age, body mass index, diabetes, hypertension, physical function, and CHD diagnosis. Analysis of physical activity as a time-varying exposure yielded findings comparable to those of baseline physical activity., Conclusions: Higher levels of recreational physical activity, including walking, are associated with significantly reduced HF risk in community-dwelling older women., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The recent resurgence of ballistocardiogram (BCG) measurement and interpretation technologies has led to a wide range of powerful tools available for unobtrusively assessing mechanical aspects of cardiovascular health at home. Researchers have demonstrated a multitude of modern BCG measurement modalities, including beds, chairs, weighing scales, and wearable approaches. However, many modalities produce significant variations in the morphology of the measured BCG, creating confusion in the analysis and interpretation of the signals. This paper creates a framework for comparing wearable BCG measurements to whole body measurements--such as taken with a weighing scale system--to eventually allow the same analysis and interpretation tools that have been developed for whole body systems to be applied in the future to wearable systems. To the best of our knowledge, it represents the first attempt to morphologically compare vertical acceleration recordings measured on different locations on the torso to whole body displacements measured by BCG instrumentation.

Heart failure (HF) is an escalating public health problem, with few effective methods for home monitoring. In HF management, the important clinical factors to monitor include symptoms, fluid status, cardiac output, and blood pressure--based on these factors, inotrope and diuretic dosages are adjusted day-by-day to control the disorder and improve the patient's status towards a successful discharge. Previously, the ballistocardiogram (BCG) measured on a weighing scale has been shown to be capable of detecting changes in cardiac output and contractility for healthy subjects. In this study, we investigated whether the BCG and electrocardiogram (ECG) signals measured on a wireless modified scale could accurately track the clinical status of HF patients during their hospital stay. Using logistic regression, we found that the root-mean-square (RMS) power of the BCG provided a good fit for clinical status, as determined based on clinical measurements and symptoms, for the 85 patient days studied from 10 patients (p < 0.01). These results provide a promising foundation for future studies aimed at using the BCG/ECG scale at home to track HF patient status remotely.

We report the case of a 70-year-old man with a history of myocardial infarction and coronary artery bypass grafting, presenting with signs and symptoms of heart failure. Cardiac magnetic resonance imaging demonstrated a small amount of scarring in the anteroseptal wall, moderate left ventricular enlargement, and a left ventricular ejection fraction of 26%. Patient was started on simvastatin 20 mg daily, gradually increased to 80 mg daily, which were maintained for another 4 weeks. Twelve weeks after the initial presentation, the patient experienced a marked improvement in his symptoms. Repeat cardiac magnetic resonance imaging showed global improvement in left ventricular contractility, with ejection fraction of 36% and end-diastolic volume decreasing from 230 to 153 ml. We speculate that high-dose statin therapy had a significant role in improving the ventricular function in our patient by improving the endothelial flow. This hypothesis is presently being tested in a larger prospective trial.

In patients presenting with acute myocardial infarction (MI), the early use of intravenous beta-blockade followed by short-term oral administration in the absence of reperfusion therapy has shown a modest reduction in mortality. In contrast, major reductions in mortality and reinfarction have been shown when beta-blockers have been used soon after an acute MI and continued long-term. These benefits were observed in trials conducted in the 1970s and 1980s, prior to the widespread use of reperfusion therapies, antiplatelet agents, and angiotensin-converting enzyme inhibitors; those trials excluded patients with postischemic heart failure. Recently, the CAPRICORN trial has shown a significant reduction in all-cause mortality and reinfarction in post-MI patients with systolic dysfunction, in response to carvedilol. In spite of compelling evidence supporting the use of beta-blockers in the post-MI setting, data published by the National Cooperative Cardiovascular Project have shown that fewer than half of all post-MI patients receive beta-blockers as long-term therapy. It appears that post-MI patients with perceived contraindications, such as advanced age, diabetes, heart failure, peripheral vascular disease, and/or chronic pulmonary obstructive disease, may derive a substantial benefit from the use of beta-blockers. Given the considerable evidence from randomized clinical trials, the use of beta-blockers is recommended in all post-MI patients without a contraindication, particularly in those with left ventricular systolic dysfunction.