Morphological Analysis of the Right Ventricular Endocardial Wall in Pulmonary Hypertension.

Pulmonary hypertension (PH) is a chronic progressive disease diagnosed when the pressure in the main pulmonary artery, assessed by right heart catheterization (RHC), is greater than 25 mmHg. Changes in the pulmonary vasculature due to the high pressure yield an increase in the right ventricle (RV) afterload. This starts a remodeling process during which the ventricle exhibits changes in shape and eventually fails. RV models were obtained from the segmentation of cardiac magnetic resonance images at baseline and 1-year follow-up for a pilot study that involved 12 PH and 7 control subjects. The models were used to create surface meshes of the geometry and to compute the principal, mean, and Gaussian curvatures. Ten global curvature indices were calculated for each of the RV endocardial wall reconstructions at the end-diastolic volume (EDV) and end-systolic volume (ESV) phases of the cardiac cycle. Statistical analysis of the data was performed to discern if there are significant differences in the curvature indices between controls and the PH group, as well as between the baseline and follow-up phases for the PH subjects. Six curvature indices, namely, the Gaussian curvature at ESV, the mean curvature at EDV and ESV, the L2-norm of the mean curvature at ESV, and the L2-norm of the major principal curvature at EDV and ESV, were found to be significantly different between controls and PH subjects (p < 0.05). We infer that these geometry measures could be used as indicators of RV endocardial wall morphology changes. Two global parameters, the Gaussian and mean curvatures at ESV, showed significant changes at the one-year follow-up for the PH subjects (p < 0.05). The aforementioned geometry measures to assess changes in RV shape could be used as part of a noninvasive computational tool to aid clinicians in PH diagnostic and progression assessment, and to evaluate the effectiveness of treatment.

Management of pulmonary hypertension due to heart failure with preserved ejection fraction.

Heart failure with preserved ejection fraction (HFpEF) is a major cause of HF-related morbidity and mortality, with no medical therapy proven to modify the underlying disease process and result in improvements in survival. With long-standing pulmonary venous congestion, a majority of HFpEF patients develop pulmonary hypertension (PH). Elevated pulmonary pressures have been shown to be a major determinant of mortality in this population. Given the paucity of available disease-modifying therapies for HFpEF, there has been a considerable interest in evaluating new therapeutic options specifically targeting PH in this patient population.

Ex vivo cardiovascular magnetic resonance measurements of right and left ventricular mass compared with direct mass measurement in excised hearts after transplantation: a first human SSFP comparison.

BACKGROUND: CMR is considered the 'gold standard' for non-invasive LV and RV mass quantitation. This information is solely based on gradient-recalled echo (GRE) sequences while contrast dependent on intrinsic T1/T2 characteristics potentially offers superior image contrast between blood and myocardium. This study aims, for the first time in humans, to validate the SSFP approach using explanted hearts obtained from heart transplant recipients. Our objective is establish the correlation between and to validate steady-state free precession (SSFP) derived LV and RV mass vs. autopsy mass of hearts from cardiac transplants patients. METHODS: Over three-years, 58 explanted cardiomyopathy hearts were obtained immediately upon orthotopic heart transplantation from the OR. They were quickly cleaned, prepared and suspended in a saline-filled container and scanned ex vivo via SSFP-SA slices to define LV/RV mass. Using an automatic thresholding program, segmentation was achieved in combination with manual trimming (ATMT) of extraneous tissue incorporating 3D cardiac modeling performed by independent and blinded readers. The explanted hearts were then dissected with the ventricles surgically separated at the interventricular septum. Weights of the total heart not excluding papillary and trabecular myocardium, LV and RV were measured via high-fidelity scale. Linear regression and Bland-Altman plots were used to analyze the data. The intra-class correlation coefficient was used to assess intra-observer reliability. RESULTS: Of the total of 58 explanted hearts, 3 (6%) were excluded due to poor image quality leaving 55 patients (94%) for the final analysis. Significant positive correlations were found between total 3D CMR mass (450 ± 111 g) and total pathology mass (445 ± 116 g; r = 0.99, p < 0.001) as well as 3D CMR measured LV mass (301 ± 93 g) and the pathology measured LV mass (313 ± 96 g; r = 0.95, p < 0.001). Strong positive correlations were demonstrated between the 3D CMR measured RV mass (149 ± 46 g) and the pathology measured RV mass (128 ± 40 g; r = 0.76, p < 0.001). The mean bias between 3D-CMR and pathology measures for total mass, LV mass and RV mass were: 3.0 g, -16 g and 19 g, respectively. CONCLUSIONS: SSFP-CMR accurately determines total myocardial, LV and RV mass as compared to pathology weighed explanted hearts despite variable surgical removal of instrumentation (left and right ventricular assist devices, AICD and often apical core removals). Thus, this becomes the first-ever human CMR confirmation for SSFP now validating the distinction of 'gold standard'.

Cost Analysis of Remote Cardiac Rehabilitation Compared With Facility-Based Cardiac Rehabilitation for Coronary Artery Disease.

Remote cardiac rehabilitation (RCR) represents a promising, noninferior alternative to facility-based cardiac rehabilitation (FBCR). The comparable cost of RCR in US populations has yet to be extensively studied. The purpose of this prospective, patient-selected study of traditional FBCR versus a third-party asynchronous RCR platform was to assess whether RCR can be administered at a comparable cost and clinical efficacy to FBCR. Adult insured patients were eligible for enrollment after an admission for a coronary heart disease event. Patients selected either FBCR or Movn RCR, a 12-week telehealth intervention using an app-based platform and internet-capable medical devices. Clinical demographics, intervention adherence, cost-effectiveness, and hospitalizations at 1-year after enrollment were assessed from the Highmark claims database after propensity matching between groups. A total of 260 patients were included and 171 of those eligible (65.8%) received at least 1 cardiac rehabilitation session and half of the patients chose Movn RCR. The propensity matching produced a sample of 41 matched pairs. Movn RCR led to a faster enrollment and higher completion rates (80% vs 50%). The total medical costs were similar between Movn RCR and FBCR, although tended toward cost savings with Movn RCR ($10,574/patient). The cost of cardiac rehabilitation was lower in those enrolled in Movn RCR ($1,377/patient, p = 0.002). The all-cause and cardiovascular-related hospitalizations or emergency department visits in the year after enrollment in both groups were similar. In conclusion, this pragmatic study of patients after a coronary heart disease event led to equivalent total medical costs and lower intervention costs for an asynchronous RCR platform than traditional FBCR while maintaining similar clinically important outcomes.

Integrating molecular and clinical variables to predict myocardial recovery.

Mechanical unloading and circulatory support with left ventricular assist devices (LVADs) mediate significant myocardial improvement in a subset of advanced heart failure (HF) patients. The clinical and biological phenomena associated with cardiac recovery are under intensive investigation. Left ventricular (LV) apical tissue, alongside clinical data, were collected from HF patients at the time of LVAD implantation (n=208). RNA was isolated and mRNA transcripts were identified through RNA sequencing and confirmed with RT-qPCR. To our knowledge this is the first study to combine transcriptomic and clinical data to derive predictors of myocardial recovery. We used a bioinformatic approach to integrate 59 clinical variables and 22,373 mRNA transcripts at the time of LVAD implantation for the prediction of post-LVAD myocardial recovery defined as LV ejection fraction (LVEF) ≥40% and LV end-diastolic diameter (LVEDD) ≤5.9cm, as well as functional and structural LV improvement independently by using LVEF and LVEDD as continuous variables, respectively. To substantiate the predicted variables, we used a multi-model approach with logistic and linear regressions. Combining RNA and clinical data resulted in a gradient boosted model with 80 features achieving an AUC of 0.731±0.15 for predicting myocardial recovery. Variables associated with myocardial recovery from a clinical standpoint included HF duration, pre-LVAD LVEF, LVEDD, and HF pharmacologic therapy, and LRRN4CL (ligand binding and programmed cell death) from a biological standpoint. Our findings could have diagnostic, prognostic, and therapeutic implications for advanced HF patients, and inform the care of the broader HF population.

Role of phosphodiesterase-5 inhibitors in heart failure: emerging data and concepts.

Novel treatment of congestive heart failure (HF) involves utilizing unique pathways to improve upon contemporary therapies. Increasing the availability of cyclic guanosine monophosphate (cGMP) by inhibition of phosphodiesterase-5 (PDE5) is a relatively new, but promising therapeutic strategy. Preclinical studies suggest a favorable myocardial effect of PDE5 inhibitors by blocking adrenergic, hypertrophic and pro-apoptotic signaling, thereby supporting their use in HF. The clinical benefits of acute and chronic PDE5 inhibition on lung diffusion capacity, exercise performance and ejection fraction in humans are emerging and appear promising. Larger, controlled trials are now on-going to assess the safety, efficacy and tolerability of PDE5 inhibitors on morbidity and mortality in patients with both systolic and diastolic heart failure. If the results of these trials are positive, a new avenue for the treatment of HF will open, which will help curtail the societal effects of this costly and morbid disease.

Cable Tension Optimization for an Epicardial Parallel Wire Robot.

HeartPrinter is a novel under-constrained 3-cable parallel wire robot designed for minimally invasive epicardial interventions. The robot adheres to the beating heart using vacuum suction at its anchor points, with a central injector head that operates within the triangular workspace formed by the anchors, and is actuated by cables for multipoint direct gene therapy injections. Minimizing cable tensions can reduce forces on the heart at the anchor points while supporting rapid delivery of accurate injections and minimizing procedure time, risk of damage to the robot, and strain to the heart. However, cable tensions must be sufficient to hold the injector head's position as the heart moves and to prevent excessive cable slack. We pose a linear optimization problem to minimize the sum of cable tension magnitudes for HeartPrinter while ensuring the injector head is held in static equilibrium and the tensions are constrained within a feasible range. We use Karush-Kuhn-Tucker optimality conditions to derive conditional algebraic expressions for optimal cable tensions as a function of injector head position and workspace geometry, and we identify regions of injector head positions where particular combinations of cable tensions are optimally at minimum allowable tensions. The approach can rapidly solve for the minimum set of cable tensions for any robot workspace geometry and injector head position and determine whether an injection site is attainable.

Salvage peripheral extracorporeal membrane oxygenation using Cobe Revolution(®) centrifugal pump as a bridge to decision for acute refractory cardiogenic shock.

OBJECTIVES: Acute refractory cardiogenic shock with early multisystem organ failure has a poor outcome without mechanical circulatory support. We review our experience with emergent peripheral cardiopulmonary support as a bridge to decision in these patients. METHODS: A retrospective review from January 2009 through December 2010 was conducted of 26 consecutive adult patients at a single institution with acute refractory cardiogenic shock who underwent salvage peripheral cardiopulmonary support. RESULTS: There were 18 men and 8 women with a mean age of 54 years (range 18 to 76). Indications for support: acute myocardial infarction (n = 16), decompensated chronic heart failure (n = 2), refractory arrhythmic arrest (n = 3), acute valvular pathology (n = 4), and unknown (n = 1). Patients with primary postcardiotomy shock were excluded. Median duration of support was 3 days (range 1 to 14). Decisions included: withdraw of support (n = 4), recovery (n = 5), and bridge to a procedure (n = 17). The procedures were percutaneous coronary intervention (n = 4), left ventricular assist device (n = 9), heart transplantation (n = 1), and miscellaneous cardiac surgery (n = 3). Overall survival to discharge was 65%. In the recovery and bridge to a procedure group, 78% were discharged from the hospital and survival at three months was 72%. CONCLUSIONS: Salvage peripheral cardiopulmonary support is a useful tool to rapidly stabilize acute refractory cardiogenic shock permitting an assessment of neurologic and end-organ viability.

Imaging in the evaluation of pulmonary artery hemodynamics and right ventricular structure and function.

Among the many approaches for evaluating patients with pulmonary hypertension (PH), imaging plays a crucial role. The primary role of imaging is to identify the severity of PH based on noninvasive hemodynamic assessment and to evaluate right ventricular morphology and function. The major modalities used in current clinical practice for these purposes are echocardiography and cardiac magnetic resonance (CMR) imaging. This review discusses the merits, limitations, and clinical utility of several echocardiographic and CMR techniques used in the evaluation of PH. It also includes a brief discussion of the role of computed tomography and radionuclide imaging.

Introducer Design Concepts for an Epicardial Parallel Wire Robot.

BACKGROUND: Cardiac gene therapies lack effective delivery methods to the myocardium. While direct injection has demonstrated success over a small region, homogenous gene expression requires many injections over a large area. To address this need, we developed a minimally invasive flexible parallel wire robot for epicardial interventions. To accurately deploy it onto the beating heart, an introducer mechanism is required. METHODS: Two mechanisms are presented. Assessment of the robot's positioning, procedure time, and pericardium insertion forces are performed on an artificial beating heart. RESULTS: Successful positioning was demonstrated. The mean procedure time was 230 ± 7 seconds for mechanism I and 259 ± 4 seconds for mechanism II. The mean pericardium insertion force was 2.2 ± 0.4 N anteriorly and 3.1 ± 0.4 N posteriorly. CONCLUSION: Introducer mechanisms demonstrate feasibility in facilitating the robot's deployment on the epicardium. Pericardium insertion forces and procedure times are consistent and reasonable.

Patient-Specific Computational Analysis of Hemodynamics in Adult Pulmonary Hypertension.

Pulmonary hypertension (PH) is a progressive disease characterized by elevated pressure and vascular resistance in the pulmonary arteries. Nearly 250,000 hospitalizations occur annually in the US with PH as the primary or secondary condition. A definitive diagnosis of PH requires right heart catheterization (RHC) in addition to a chest computed tomography, a walking test, and others. While RHC is the gold standard for diagnosing PH, it is invasive and posseses inherent risks and contraindications. In this work, we characterized the patient-specific pulmonary hemodynamics in silico for diverse PH WHO groups. We grouped patients on the basis of mean pulmonary arterial pressure (mPAP) into three disease severity groups: at-risk ([Formula: see text], denoted with A), mild ([Formula: see text], denoted with M), and severe ([Formula: see text], denoted with S). The pulsatile flow hemodynamics was simulated by evaluating the three-dimensional Navier-Stokes system of equations using a flow solver developed by customizing OpenFOAM libraries (v5.0, The OpenFOAM Foundation). Quasi patient-specific boundary conditions were implemented using a Womersley inlet velocity profile and transient resistance outflow conditions. Hemodynamic indices such as spatially averaged wall shear stress ([Formula: see text]), wall shear stress gradient ([Formula: see text]), time-averaged wall shear stress ([Formula: see text]), oscillatory shear index ([Formula: see text]), and relative residence time ([Formula: see text]), were evaluated along with the clinical metrics pulmonary vascular resistance ([Formula: see text]), stroke volume ([Formula: see text]) and compliance ([Formula: see text]), to assess possible spatiotemporal correlations. We observed statistically significant decreases in [Formula: see text], [Formula: see text], and [Formula: see text], and increases in [Formula: see text] and [Formula: see text] with disease severity. [Formula: see text] was moderately correlated with [Formula: see text] and [Formula: see text] at the mid-notch stage of the cardiac cycle when these indices were computed using the global pulmonary arterial geometry. These results are promising in the context of a long-term goal of identifying computational biomarkers that can serve as surrogates for invasive diagnostic protocols of PH.

Coronary vessel detection methods for organ-mounted robots.

BACKGROUND: HeartLander is a tethered robot walker that utilizes suction to adhere to the beating heart. HeartLander can be used for minimally invasive administration of cardiac medications or ablation of tissue. In order to administer injections safely, HeartLander must avoid coronary vasculature. METHODS: Doppler ultrasound signals were recorded using a custom-made cardiac phantom and used to classify different coronary vessel properties. The classification was performed by two machine learning algorithms, the support vector machines and a deep convolutional neural network. These algorithms were then validated in animal trials. RESULTS: Accuracy of identifying vessels above turbulent flow reached greater than 92% in phantom trials and greater than 98% in animal trials. CONCLUSIONS: Through the use of two machine learning algorithms, HeartLander has shown the ability to identify different sized vasculature proximally above turbulent flow. These results indicate that it is feasible to use Doppler ultrasound to identify and avoid coronary vasculature during cardiac interventions using HeartLander.

Retrospective Analysis and Forecasted Economic Impact of a Virtual Cardiac Rehabilitation Program in a Third-Party Payer Environment.

Background: Participation in cardiac rehabilitation (CR) is recommended for all patients with coronary artery disease (CAD) following hospitalization for acute coronary syndrome or stenting. Yet, few patients participate due to the inconvenience and high cost of attending a facility-based program, factors which have been magnified during the ongoing COVID pandemic. Based on a retrospective analysis of CR utilization and cost in a third-party payer environment, we forecasted the potential clinical and economic benefits of delivering a home-based, virtual CR program, with the goal of guiding future implementation efforts to expand CR access. Methods: We performed a retrospective cohort study using insurance claims data from a large, third-party payer in the state of Pennsylvania. Primary diagnostic and procedural codes were used to identify patients admitted for CAD between October 1, 2016, and September 30, 2018. Rates of enrollment in facility-based CR, as well as all-cause and cardiovascular hospital readmission and associated costs, were calculated during the 12-months following discharge. Results: Only 37% of the 7,264 identified eligible insured patients enrolled in a facility-based CR program within 12 months, incurring a mean delivery cost of $2,922 per participating patient. The 12-month all-cause readmission rate among these patients was 24%, compared to 31% among patients who did not participate in CR. Furthermore, among those readmitted, CR patients were readmitted less frequently than non-CR patients within this time period. The average per-patient cost from hospital readmissions was $30,814 per annum. Based on these trends, we forecasted that adoption of virtual CR among patients who previously declined CR would result in an annual cost savings between $1 and $9 million in the third-party healthcare system from a combination of increased overall CR enrollment and fewer hospital readmissions among new HBCR participants. Conclusions: Among insured patients eligible for CR in a third-party payer environment, implementation of a home-based virtual CR program is forecasted to yield significant cost savings through a combination of increased CR participation and a consequent reduction in downstream healthcare utilization.

Objective determination of peripheral edema in heart failure patients using short-wave infrared molecular chemical imaging.

SIGNIFICANCE: Peripheral pitting edema is a clinician-administered measure for grading edema. Peripheral edema is graded 0, 1 + , 2 + , 3 + , or 4 + , but subjectivity is a major limitation of this technique. A pilot clinical study for short-wave infrared (SWIR) molecular chemical imaging (MCI) effectiveness as an objective, non-contact quantitative peripheral edema measure is underway. AIM: We explore if SWIR MCI can differentiate populations with and without peripheral edema. Further, we evaluate the technology for correctly stratifying subjects with peripheral edema. APPROACH: SWIR MCI of shins from healthy subjects and heart failure (HF) patients was performed. Partial least squares discriminant analysis (PLS-DA) was used to discriminate the two populations. PLS regression (PLSR) was applied to assess the ability of MCI to grade edema. RESULTS: Average spectra from edema exhibited higher water absorption than non-edema spectra. SWIR MCI differentiated healthy volunteers from a population representing all pitting edema grades with 97.1% accuracy (N = 103 shins). Additionally, SWIR MCI correctly classified shin pitting edema levels in patients with 81.6% accuracy. CONCLUSIONS: Our study successfully achieved the two primary endpoints. Application of SWIR MCI to monitor patients while actively receiving HF treatment is necessary to validate SWIR MCI as an HF monitoring technology.

Sequential Pattern Mining of Longitudinal Adverse Events After Left Ventricular Assist Device Implant.

Left ventricular assist devices (LVADs) are an increasingly common therapy for patients with advanced heart failure. However, implantation of the LVAD increases the risk of stroke, infection, bleeding, and other serious adverse events (AEs). Most post-LVAD AEs studies have focused on individual AEs in isolation, neglecting the possible interrelation, or causality between AEs. This study is the first to conduct an exploratory analysis to discover common sequential chains of AEs following LVAD implantation that are correlated with important clinical outcomes. This analysis was derived from 58,575 recorded AEs for 13,192 patients in International Registry for Mechanical Circulatory Support (INTERMACS) who received a continuous-flow LVAD between 2006 and 2015. The pattern mining procedure involved three main steps: (1) creating a bank of AE sequences by converting the AEs for each patient into a single, chronologically sequenced record, (2) grouping patients with similar AE sequences using hierarchical clustering, and (3) extracting temporal chains of AEs for each group of patients using Markov modeling. The mined results indicate the existence of seven groups of sequential chains of AEs, characterized by common types of AEs that occurred in a unique order. The groups were identified as: GRP1: Recurrent bleeding, GRP2: Trajectory of device malfunction & explant, GRP3: Infection, GRP4: Trajectories to transplant, GRP5: Cardiac arrhythmia, GRP6: Trajectory of neurological dysfunction & death, and GRP7: Trajectory of respiratory failure, renal dysfunction & death. These patterns of sequential post-LVAD AEs disclose potential interdependence between AEs and may aid prediction, and prevention, of subsequent AEs in future studies.

A canonical correlation analysis of the relationship between clinical attributes and patient-specific hemodynamic indices in adult pulmonary hypertension.

Pulmonary hypertension (PH) is a progressive disease affecting approximately 10-52 cases per million, with a higher incidence in women, and with a high mortality associated with right ventricle (RV) failure. In this work, we explore the relationship between hemodynamic indices, calculated from in silico models of the pulmonary circulation, and clinical attributes of RV workload and pathological traits. Thirty-four patient-specific pulmonary arterial tree geometries were reconstructed from computed tomography angiography images and used for volume meshing for subsequent computational fluid dynamics (CFD) simulations. Data obtained from the CFD simulations were post-processed resulting in hemodynamic indices representative of the blood flow dynamics. A retrospective review of medical records was performed to collect the clinical variables measured or calculated from standard hospital examinations. Statistical analyses and canonical correlation analysis (CCA) were performed for the clinical variables and hemodynamic indices. Systolic pulmonary artery pressure (sPAP), diastolic pulmonary artery pressure (dPAP), cardiac output (CO), and stroke volume (SV) were moderately correlated with spatially averaged wall shear stress (0.60 ≤ R2 ≤ 0.66; p < 0.05). Similarly, the CCA revealed a linear and strong relationship (ρ = 0.87; p << 0.001) between 5 clinical variables and 2 hemodynamic indices. To this end, in silico models of PH blood flow dynamics have a high potential for predicting the relevant clinical attributes of PH if analyzed in a group-wise manner using CCA.

Factors Affecting Health Care Engagement of Patients With End-Stage Heart Failure: An Exploratory Survey Study.

Background. The decision to receive a permanent left ventricular assist device (LVAD) to treat end-stage heart failure (HF) involves understanding and weighing the risks and benefits of a highly invasive treatment. The goal of this study was to characterize end-stage HF patients across parameters that may affect their decision making and to inform the development of an LVAD decision support tool. Methods. A survey of 35 end-stage HF patients at an LVAD implant hospital was performed to characterize their information-seeking habits, interaction with physicians, technology use, numeracy, and concerns about their health. Survey responses were analyzed using descriptive statistics, grounded theory method, and Bayesian network learning. Results. Most patients indicated an interest in using some type of decision support tool (roadmap of health progression: 46%, n = 16; personal prognosis: 51%, n = 18; short videos of patients telling stories of their experiences with an LVAD: 57%, n = 20). Information patients desired in a hypothetical decision support tool fell into the following topics: prognoses for health outcomes, technical information seeking, expressing emotions, and treatment decisions. Desire for understanding their condition was closely related to whether they had difficult interpreting their electronic medical record in the past. Conclusions. Most patients reported interest in engaging in their health care decision making and seeing their prognosis and electronic health record information. Patients who were less interested in their own treatment decisions were characterized by having less success understanding their health information. Design of a decision support tool for potential LVAD patients should consider a spectrum of health literacy and include information beyond the technical specifications of LVAD support.

Risk Assessment in Patients with a Left Ventricular Assist Device Across INTERMACS Profiles Using Bayesian Analysis.

Current risk stratification models to predict outcomes after a left ventricular assist device (LVAD) are limited in scope. We assessed the performance of Bayesian models to stratify post-LVAD mortality across various International Registry for Mechanically Assisted Circulatory Support (INTERMACS or IM) Profiles, device types, and implant strategies. We performed a retrospective analysis of 10,206 LVAD patients recorded in the IM registry from 2012 to 2016. Using derived Bayesian algorithms from 8,222 patients (derivation cohort), we applied the risk-prediction algorithms to the remaining 2,055 patients (validation cohort). Risk of mortality was assessed at 1, 3, and 12 months post implant according to disease severity (IM profiles), device type (axial versus centrifugal) and strategy (bridge to transplantation or destination therapy). Fifteen percentage (n = 308) were categorized as IM profile 1, 36% (n = 752) as profile 2, 33% (n = 672) as profile 3, and 15% (n = 311) as profile 4-7 in the validation cohort. The Bayesian algorithms showed good discrimination for both short-term (1 and 3 months) and long-term (1 year) mortality for patients with severe HF (Profiles 1-3), with the receiver operating characteristic area under the curve (AUC) between 0.63 and 0.74. The algorithms performed reasonably well in both axial and centrifugal devices (AUC, 0.68-0.74), as well as bridge to transplantation or destination therapy indication (AUC, 0.66-0.73). The performance of the Bayesian models at 1 year was superior to the existing risk models. Bayesian algorithms allow for risk stratification after LVAD implantation across different IM profiles, device types, and implant strategies.

Sex-Based Differences in Left Ventricular Assist Device Utilization: Insights From the Nationwide Inpatient Sample 2004 to 2016.

BACKGROUND: Women comprise approximately one-third of the advanced heart failure population but may receive fewer advanced heart failure therapies including left ventricular assist devices (LVADs). During the early pulsatile-flow device era, women had higher post-LVAD mortality and increased complications. However, knowledge about these differences in the continuous-flow device era is limited. Therefore, we sought to explore temporal trends in LVAD utilization and post-LVAD mortality by sex. METHODS AND RESULTS: Patients with LVAD implantation from 2004 to 2016 were identified using the Nationwide Inpatient Sample. Trends in LVAD utilization and post-LVAD inpatient mortality were compared by sex and device era. Although LVADs are being increasingly utilized for patients with advanced systolic heart failure, women continue to represent a smaller proportion of LVAD recipients-25.8% in 2004 to 21.9% in 2016 (P for trend, 0.91). Women had increased inpatient mortality after LVAD implantation compared with men in the pulsatile-flow era (46.9% versus 31.1%, P<0.0001) but not in the continuous-flow era (13.3% versus 12.1%, P=0.27; P for interaction=0.0002). Inpatient mortality decreased for both sexes over time after LVAD, with a sharp fall in 2008 to 2009. Female sex was independently associated with increased post-LVAD inpatient mortality beyond adjustment for demographics and risk factors during the pulsatile-flow era (odds ratio, 2.13; 95% CI, 1.45-3.10; P<0.0001) but not during the continuous-flow era (1.18; 0.93-1.48; P=0.16). CONCLUSIONS: Although utilization of LVAD therapy increased over time for both sexes, LVAD implantation remains stably lower in women, which may suggest a potential underutilization of this potentially life-saving therapy. Prospective studies are needed to confirm these findings.

Monitoring Pulmonary Arterial Hypertension Using an Implantable Hemodynamic Sensor.

BACKGROUND: Pulmonary arterial hypertension (PAH) is a chronic disease that ultimately progresses to right-sided heart failure (HF) and death. Close monitoring of pulmonary artery pressure (PAP) and right ventricular (RV) function allows clinicians to appropriately guide therapy. However, the burden of commonly used methods to assess RV hemodynamics, such as right heart catheterization, precludes frequent monitoring. The CardioMEMS HF System (Abbott) is an ambulatory implantable hemodynamic monitor, previously only used in patients with New York Heart Association (NYHA) class III HF. In this study, we evaluate the feasibility and early safety of monitoring patients with PAH and right-sided HF using the CardioMEMS HF System. METHODS: The CardioMEMS HF sensors were implanted in 26 patients with PAH with NYHA class III or IV right-sided HF (51.3 ± 18.3 years of age, 92% women, 81% NYHA class III). PAH therapy was tracked using a minimum of weekly reviews of CardioMEMS HF daily hemodynamic measurements. Safety, functional response, and hemodynamic response were tracked up to 4 years with in-clinic follow-ups. RESULTS: The CardioMEMS HF System was safely used to monitor PAH therapy, with no device-related serious adverse events observed and a single preimplant serious adverse event. Significant PAP reduction and cardiac output elevation were observed as early as 1 month postimplant using trends of CardioMEMS HF data, coupled with significant NYHA class and quality of life improvements within 1 year. CONCLUSIONS: The CardioMEMS HF System provided useful information to monitor PAH therapy, and demonstrated short- and long-term safety. Larger clinical trials are needed before its widespread use to guide therapy in patients with severe PAH with right-sided HF.