Guide Heart Failure Management Research Articles

Physician-directed patient self-management in heart failure using left atrial pressure: Interim insights from the VECTOR-HF I and IIa studies.

Haemodynamic monitoring using implantable pressure sensors reduces the risk of heart failure (HF) hospitalizations. Patient self-management (PSM) of haemodynamics in HF has the potential to personalize treatment, increase adherence, and reduce the risk of worsening HF, while lowering clinicians' burden. The VECTOR-HF I and IIa studies are prospective, single-arm, open-label clinical trials assessing safety, usability and performance of left atrial pressure (LAP)-guided HF management using PSM in New York Heart Association class II and III HF patients. Physician-prescribed LAP thresholds trigger patient self-adjustment of diuretics. Primary endpoints include the ability to perform LAP measurements and transmit data to the healthcare provider (HCP) interface and the patient guidance application, and safety outcomes. This is an interim analysis of 13 patients using the PSM approach. Over 12 months, no procedure- or device-related major adverse cardiovascular or neurological events were observed, and there were no failures to obtain measurements from the sensor and transmit the data to the HCP interface and the patient guidance application. Patient adherence was 91.4%. Using PSM, annualized HF hospitalization rate significantly decreased compared to a similar period prior to PSM utilization (0 admissions vs. 0.69 admissions over 11.84 months, p = 0.004). At 6 months, 6-min walk test distance and the Kansas City Cardiomyopathy Questionnaire overall summary score demonstrated significant improvement. Interim findings suggest that PSM using a LAP monitoring system is feasible and safe. PSM is associated with high patient adherence, potentially improving HF patients' functional status, quality of life, and limiting HF hospitalizations.

Value of left ventricular longitudinal strain in predicting overt heart failure in patients with Chagas disease and preserved left ventricular ejection fraction

Abstract Introduction Speckle-tracking echocardiography (STE) is an established tool to detect early myocardial contractile impairment. In Chagas disease patients, STE may be helpful to identify subtle myocardial damage with the potential of progression to heart failure. Purpose This study aimed to assess the value of STE in predicting heart failure in Chagas disease patients with preserved left ventricular ejection fraction (LVEF). Methods Patients with Chagas disease living in endemic area who had preserved LVEF (>50%) were selected for the study. Clinical evaluation, B-type natriuretic peptide (NT-ProBNP), electrocardiogram (ECG), and echocardiogram were performed at enrollment in 2015 to 2016 and in the follow-up visit between 2018 and 2019. Global longitudinal strain (GLS) derived from STE was analyzed offline. Peak GLS was calculated as the mean value from 18 segments of the left ventricle (Figure 1). The outcome was development of heart failure defined by elevation of NT-ProBNP levels, categorized according to age-specific cut-points for heart failure at the second evaluation. Patients with abnormal NT-ProBNP at baseline or those who died between the 2 visits were not included. Results A total of 692 were enrolled, mean age was 58 ± 12 years and 495 (72%) were women. Mean LVEF at baseline and follow-up visits were 63.4 ± 4.6% and 59.8 ± 11.2% (p<0.001). The median [IQR] time between visit 1 and visit 2 was 5.4 [4.5 - 5.8] years. Among patients alive and attending the second visit, 48 patients (7%) developed overt heart failure with overall incidence rate of 14.1 events per 1000 patient-years (95% CI 10.4-18.6). On multivariable analysis, independent predictors of new-onset heart failure were male sex (OR 2.30, 95% CI 1.02-5.18), age (OR 1.04, 95% CI 1.01-1.07), QRS duration (OR 1.03, 95% CI 1.01-1.04), left atrial (LA) volume indexed (OR 1.05, 95% CI 1.01-1.09), and GLS (OR 0.90, 95% CI 0.81-0.98). LVEF did not remain in the model. The C-statistic of the final model was 0.80 (95% CI 71-88) showing a good discrimination. Conclusions In a cohort of patients with Chagas disease from remote areas with preserved ejection fraction, GLS was an important predictor of progression to overt heart failure, after adjustment for sex, age, QRS duration and LA volume. GLS was associated with further increased NT-ProBNP levels, which is useful to guide heart failure management, irrespective of systolic dysfunction.

Heart failure management guided by remote multiparameter monitoring: A meta-analysis

BackgroundSeveral implant-based remote monitoring strategies are currently tested to optimize heart failure (HF) management by anticipating clinical decompensation and preventing hospitalization. Among these solutions, the modern implantable cardioverter-defibrillator and cardiac resynchronization therapy devices have been equipped with sensors allowing continuous monitoring of multiple preclinical markers of worsening HF, including factors of autonomic adaptation, patient activity, and intrathoracic impedance. ObjectivesWe aimed to assess whether implant-based multiparameter remote monitoring strategy for guided HF management improves clinical outcomes when compared to standard clinical care. MethodsA systematic literature research for randomized controlled trials (RCTs) comparing multiparameter-guided HF management versus standard of care was performed on PubMed, Embase, and CENTRAL databases. Incidence rate ratios (IRRs) and associated 95% confidence intervals (CIs) were calculated using the Poisson regression model with random study effects. The primary outcome was a composite of all-cause death and HF hospitalization events, whereas secondary endpoints included the individual components of the primary outcome. ResultsOur meta-analysis included 6 RCTs, amounting to a total of 4869 patients with an average follow-up time of 18 months. Compared with standard clinical management, the multiparameter-guided strategy reduced the risk of the primary composite outcome (IRR 0.83, 95%CI 0.71–0.99), driven by statistically significant effect on both HF hospitalization events (IRR 0.75, 95%CI 0.61–0.93) and all-cause death (IRR 0.80, 95%CI 0.66–0.96). ConclusionImplant-based multiparameter remote monitoring strategy for guided HF management is associated with significant benefit on clinical outcomes compared to standard clinical care, providing a benefit on both hospitalization events and all-cause death.

Device-based remote monitoring strategies for guided management of patients with heart failure: a systematic review and meta-analysis

Abstract Background Preclinical predictors of worsening heart failure can be monitored by implanted devices and may support the management of patients with heart failure. However, clinical results of such an approach are controversial. Purpose We aimed to assess if guided heart failure management according to device-based remote monitoring strategies is more effective than standard therapy. Methods A comprehensive literature research for randomized controlled trials (RCTs) comparing a strategy of guided heart failure management versus standard therapy was performed on PubMed, Embase, and CENTRAL databases. Incidence rate ratios (IRRs) and associated 95% confidence intervals (CIs) were calculated using the Poisson regression model with random study effects. The primary outcome was a composite of all-cause death and hospitalizations for heart failure. Secondary endpoints included the individual components of the primary outcome. Results A total of 9216 patients from 14 RCTs were included. The average follow-up duration was of 16 months. Compared with standard therapy, guided heart failure management reduced the risk of the composite of all-cause death and hospitalizations for heart failure (IRR 0.86, 95% CI 0.79–0.94, p<0.001), driven by a reduction in both all-cause death (IRR 0.88, 95% CI 0.77–1.00, p=0.049) and hospitalizations for heart failure (IRR 0.83, 95% CI 0.75–0.92, p<0.001). Findings varied according to the type of parameters monitored, with haemodynamic-guided and multiparameter-guided strategies yielding favorable effects, while impedance-guided strategy was not able to provide significant benefits. Conclusion Device-based remote monitoring systems as a tool to guide the management of patients with heart failure were associated with a valuable reduction in the risks of death, hospitalizations for heart failure, and the composite of both, supporting their routine use in clinical practice. Funding Acknowledgement Type of funding sources: None.

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

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. 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. 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.

Accurate Estimation of Right-Filling Pressure Using Handheld Ultrasound Score in Patients with Heart Failure

IntroductionThis study aims to evaluate the accuracy of bedside assessment of inferior vena cava (IVC) and right internal jugular (RIJ) vein in predicting right atrial (RA) pressure in heart failure patients. MethodsWe prospectively studied 124 heart failure patients who were referred to our catheterization laboratory for right heart catheterizations to assess hemodynamics and to guide heart failure management. Just prior to the procedure, a handheld ultrasound examination was performed in each patient. The volume status was assessed by estimating RA pressure using end-expiratory IVC dimension, IVC respiratory collapsibility, and RIJ respiratory collapsibility. Patients were divided into 2 groups based on invasive RA pressure value. Multiple logistic regression models were used to identify factors associated with RA ≥10 mm Hg; a 3-point simple score was then created. The performance of this score was assessed using the receiver operating characteristics curve. ResultsIn this study 124 heart failure patients were included; median age was 59 years (interquartile range 48-65), and 40% were female. RIJ respiratory collapsibility <50%, end-expiratory IVC dimension ≥21 mm, and respiratory collapsibility <50% were significantly associated with elevated RA pressure, and were used to build the score. The area under the receiver operating characteristics curve (AUC) for the 3-point score was 0.84 (0.77-0.92), and it performed better than 2-point score using IVC characteristics alone (AUC 0.84 [0.77-0.92] vs 0.75 [0.67-0.83]; P = .003). Of 124 patients, 90 patients (72.5%) had concordant RA pressure and pulmonary capillary wedge pressure. ConclusionConcomitant ultrasound assessment of RIJ and IVC correlated better with RA pressure than IVC alone. A simple 3-point score can provide a useful and easily accessible tool to estimate volume status, and further guide management of heart failure patients.

Echocardiographic Global Longitudinal Strain Is Associated With Myocardial Fibrosis and Predicts Outcomes in Aortic Stenosis.

Aims: Left ventricular ejection fraction is the conventional measure used to guide heart failure management, regardless of underlying etiology. Left ventricular global longitudinal strain (LV-GLS) by speckle tracking echocardiography (STE) is a more sensitive measure of intrinsic myocardial function. We aim to establish LV-GLS as a marker of replacement myocardial fibrosis on cardiovascular magnetic resonance (CMR) and validate the prognostic value of LV-GLS thresholds associated with fibrosis.Methods and results: LV-GLS thresholds of replacement fibrosis were established in the derivation cohort: 151 patients (57 ± 10 years; 58% males) with hypertension who underwent STE to measure LV-GLS and CMR. Prognostic value of the thresholds was validated in a separate outcome cohort: 261 patients with moderate-severe aortic stenosis (AS; 71 ± 12 years; 58% males; NYHA functional class I–II) and preserved LVEF ≥50%. Primary outcome was a composite of cardiovascular mortality, heart failure hospitalization, and myocardial infarction. In the derivation cohort, LV-GLS demonstrated good discrimination (c-statistics 0.74 [0.66–0.83]; P < 0.001) and calibration (Hosmer-Lemeshow χ2 = 6.37; P = 0.605) for replacement fibrosis. In the outcome cohort, 47 events occurred over 16 [3.3, 42.2] months. Patients with LV-GLS > −15.0% (corresponding to 95% specificity to rule-in myocardial fibrosis) had the worst outcomes compared to patients with LV-GLS < −21.0% (corresponding to 95% sensitivity to rule-out myocardial fibrosis) and those between −21.0 and −15.0% (log-rank P < 0.001). LV-GLS offered independent prognostic value over clinical variables, AS severity and echocardiographic LV mass and E/e′.Conclusion: LV-GLS thresholds associated with replacement myocardial fibrosis is a novel approach to risk-stratify patients with AS and preserved LVEF.

Natriuretic peptide dynamics with remote pulmonary artery pressure monitoring

Abstract Background Real-life clinical practice has confirmed the value of pulmonary artery (PA) pressure-guided therapy in patients with heart failure (HF) and history of repeated HF hospitalizations (HFH), to greater extent to that reported in the pivotal clinical trial CHAMPION-HF. The value of hemodynamic monitoring in a population of patients with HF and elevated natriuretic peptides, but without recent HFH, is unknown. Objective To assess N-terminal-pro-brain natriuretic peptide (NTproBNP) dynamics before and 6 months after PA pressure sensor implantation. Methods Ten patients managed in a multidisciplinary HF clinic implanted with the CardioMEMS PA pressure sensor were consecutively included from June 2019 to July 2020. Mean age was 63.1±23.5 years, 30% were women, 40% had HF with reduced EF (EF &amp;lt;40%). NTproBNP was measured at baseline and six months after sensor implantation. Wilcoxon matched-pairs signed-rank test was used to compare NTproBNP values at baseline and at 6 months. Fractional polynomial fit plot was used to represent changes in mean PA pressure over time. Linear regression was used to predict the change in NTproBNP based on the change in PA pressures. Results Mean daily pressure transmission rate was 92.4±5.1%. During the six-month study period 90% of patients had a change in medication related to PA pressure, with an average of 0.21 [0.17–0.66] changes per patient per month. Mean PA pressure at baseline was 28.5±9.5 mmHg, and decreased by 5.5 mmHg at 6 months (p=0.01) (Figure 1). NTproBNP was also significantly lower six months post CardioMEMS implantation; decreasing from 1696 pg/ml [976–2930] at baseline to 1046 pg/ml [616–2076] after six months (p=0.04) (Figure 2). There was a weak correlation between the change in NTproBNP and the change in mean PA pressure (R2=0.22, p=0.17). Conclusions NTproBNP values were significantly lower 6-months following implantation of a PA pressure sensor to guide HF management. Mean PA pressures were also significantly reduced. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Hospital Universitari Germans Trias i Pujol Figure 1. Change in mean PA pressure over time.Figure 2. Change in NTproBNP after PAP monitoring.

Innovations in Cardiac Implantable Electronic Devices.

Cardiac implantable electronic devices (CIEDs) are essential for the management of a variety of cardiac conditions, including tachyarrhythmias, bradyarrhythmias, and medically refractory heart failure (HF). Recent advancements in CIED technology have led to innovative solutions that overcome shortcomings associated with traditional devices or address unmet needs. Leadless pacemakers, subcutaneous implantable cardioverter defibrillators (ICDs), and extravascular ICDs eliminate lead-related complications common with conventional pacemakers or ICDs. Conduction system pacing (His bundle pacing and left bundle branch pacing) is a more physiologic method of pacing and avoids the deleterious consequences associated with long-term right ventricular pacing. For HF-related devices, cardiac contractility modulation is an emerging therapy that bridges a gap for many patients ineligible for cardiac resynchronization therapy and has been shown to improve HF symptoms and decrease hospitalizations and mortality in select patients. Implantable pulmonary artery pressure monitors help guide HF management and reduce hospitalizations. Lastly, new phrenic nerve stimulating devices are being utilized to treat central sleep apnea, a common comorbidity associated with HF. While further long-term studies are still underway for many of these new technologies, it is anticipated that these devices will become indispensable therapeutics in the expanding cardiovascular armamentarium.

Abstract 13875: Pulmonary Artery Pressure Guided Heart Failure Management Reduces Hospitalizations Across All Stages of Chronic Kidney Disease

Introduction: Pulmonary artery pressure (PAP)-guided treatment reduces heart failure hospitalizations (HFH) in randomized and “real world” studies. Underlying CKD in HF patients portends poorer outcomes. This analysis was performed to determine if benefit of PAP-guided HF therapy persists with increasing CKD severity. Methods: This retrospective cohort study was conducted in NYHA Class III HF recipients of the PAP sensor enrolled in the CardioMEMS Post Approval Study. Patients were subdivided into quartiles of glomerular filtration rates estimated by MDRD equation (eGFR). Rates of HFH 1 year before versus 1 year after PAP sensor implantation were compared across quartiles of eGFR using the Andersen-Gill Cox proportional hazards model, while accounting for competing risk of death, advanced HF therapies, and progression to end-stage kidney disease. Multivariate analysis was performed to identify independent predictors of CKD (baseline eGFR &lt; 90 mL/min/1,73m 2 ) progression. Results: Among 1200 PAP sensor recipients, 1119 had concomitant CKD with CKD stages 3 and 4 occurring in 754 patients (67.4%). In CKD patients, 40.6%, 42.1%, and 17.3%, respectively, demonstrated worse, unchanged, or improved CKD stage. Compared to 12 pre-implant months, HFH rates dropped in 12 months after implant across all eGFR quartiles (Table). PA systolic, diastolic, and mean pressures decreased from baseline to 24 months in all GFR quartiles. The baseline mean PAP as a continuous variable independently predicted CKD progression (OR: 1.027, p= 0.0006). Conclusion: Reduction of HFH by PAP-guided therapy occurred across CKD stages in a large HF population receiving the CardioMEMS sensor after Food and Drug Administration approval. Thus, PAP monitoring enables safe HF therapy optimization even in patients with advanced CKD. Since higher baseline mean PAP independently forecasts CKD worsening, HF patients with this unfavorable hemodynamic value require intensified monitoring.

Midodrine As A Bridge To Enable Use of Life Enhancing Therapies In Chronic Heart Failure

Introduction The pathophysiology of heart failure (HF) is characterized by hemodynamic, neurohormonal and autonomic perturbations. Alterations in receptor activation from this autonomic imbalance may have profound effects on cardiac function and structure. The optimal counteraction of the excessive sympathetic activity is still unclear. An excessive blockade of the sympathetic nervous system may result in adverse outcomes. Evidence from preclinical and human studies reveals that α1-adrenergic receptors mediate adaptive and protective effects in the heart. Midodrine is an α1 receptor agonist exerting its actions via activation of the alpha-adrenergic receptors of the arteriolar and venous vasculature, producing an increase in vascular tone and elevation of blood pressure without stimulating cardiac beta-adrenergic receptors. Hypothesis Use of midodrine to improve autonomic dysfunction and SBP, thus enabling optimization of life saving medications, has not been evaluated adequately. Methods The goal of the Cardiorenal center is to reduce 30-day hHF, 90-day hHF, optimize GDMT, improve QOL, prevent CKD progression, and enhance survival. A comprehensive, multidisciplinary, nurse-directed, physician guided heart failure management program including those with CKD was started in 2017. The program of intensive face to face weekly or bimonthly encounters demonstrated fewer rehospitalizations and improved QOL. The multicomponent program consists of the INSPIRE HF framework: 1) Identify individualized priorities and nature of multimorbidity, 2) Nutrition intervention, 3) Stabilize fluid status 4) Psychosocial motivational empowerment, 5) Initiate GDMT 6) Revisit comorbidities with biomarker assessments and 7) Education and exercise programs.. A total of 162 patients discharged from the hospital enrolled within a week at the clinic were followed for 30 months on a weekly basis. Sixty patients were identified as having autonomic dysfunction with low SBP Results A total of 60 patients (Men 67 %, F 33 %) were started on midodrine. Mean midodrine dose was 20.7 mg a day .Over a period of 6 weeks, 75% of patients were able to be initiated on beta blockers (p=0.04); 50 % on ARNI (p=0.08) and 33 % on MRA (p Conclusion Cardio-selective α1-AR activation with low doses of agonists such as midodrine appears to be feasible, safe and enables GDMT utilization in patients with autonomic dysfunction and hypotension. Further randomized clinical trial may be beneficial in understanding the role of alpha agonists in patients with heart failure.

Inspire - HF Manifesto Reduces Readmissions And Improves Outcomes In Chronic Heart Failure

Introduction Multiple co-morbidity is common in patients with HF increasing their risk for poor health outcomes. In the US, approximately 40% of Medicare beneficiaries with HF have >5 non-cardiac conditions and this group accounts for >80% of the total inpatient HF-related hospital days in the US. Annual total costs for HF is more than $ 40 B and the majority (61%) of hospital readmissions are attributable to multimorbidity and occur within 15-days of discharge. Most of these HF admissions and readmissions are preventable. A proactive management strategies are needed to address all comorbidities such as hypertension, diabetes, dyslipidemia, metabolic derangement, worsening renal function, and repetitive hospitalizations that ultimately lead to loss of psychosocial and financial independence, anxiety, depression, poor coping skills, falls, sarcopenia and death. Hypothesis Use of a novel framework such as INSPIRE -HF will address multiple comorbidities and improve outcomes Methods A comprehensive, multidisciplinary, nurse-directed, physician guided heart failure management program including those with CKD was started in 2017. The goal of the Cardiorenal center is to reduce 30-day hHF, 90-day hHF, optimize GDMT, improve QOL, prevent CKD progression, and enhance survival .The program consists of intensive face to face weekly or bimonthly encounters in patients enrolled at this clinic within a week after discharge from the hospital for CHF. The multicomponent program consists of the INSPIRE HF framework: 1) Identify individualized priorities and nature of multimorbidity, 2) Nutrition intervention including management of diabetes, obesity, hypertension, dyslipidemia and poor functional capacity, 3) Stabilize fluid status 4) Psychosocial motivational empowerment and financial assistance as needed, 5) Initiate GDMT 6) Revisit comorbidities with biomarker assessments and 7) Education and exercise programs including EECP therapy for those who qualify. A total of 162 patients discharged from the hospital enrolled within a week at the clinic were followed for 30 months on a weekly or bimonthly basis. Results A total of 162 patients (Men 66 %, Systolic HF 69%, Ischemic etiology 55%, 35 % with diabetes, 27 % hypertensive and 58 % with CKD) were started on the INSPIRE Strategy driven protocol. Total of 27 patients (16 %) were admitted during the 30-month period of which 8 patients (5%) were readmitted within 30 days and 19 patients (11%) were readmitted in the subsequent 180 days. Twenty-seven patients have died (16.7%) during this period. Fifty-nine patients received IV diuretics at some point during their visits and averted readmission (37%). More than 90% improved by at least 1 NYHA functional class. Conclusion A comprehensive multiple comorbidity management strategy in a nurse directed physician guided outpatient cardiometabolic renal center using the INSPIRE HF manifesto improves HF outcomes.

Pulmonary artery pressure-guided therapy in ambulatory patients with symptomatic heart failure: the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF).

Heart failure (HF) leads to repeat hospitalisations and reduces the duration and quality of life. Pulmonary artery pressure (PAP)-guided HF management using the CardioMEMS™ HF system was shown to be safe and reduce HF hospitalisation (HFH) rates in New York Heart Association (NYHA) class III patients. However, these findings have not been replicated in health systems outside the United States. Therefore, the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF) evaluated the safety, feasibility, and performance of this device in Germany, The Netherlands, and Ireland. A total of 234 NYHA class III patients (68 ± 11 years, 22% female, ≥1 HFH in the preceding year) from 31 centres were implanted with a CardioMEMS sensor and underwent PAP-guided HF management. One-year rates of freedom from device- or system-related complications and from sensor failure (co-primary outcomes) were 98.3% [95% confidence interval (CI) 95.8-100.0] and 99.6% (95% CI 97.6-100.0), respectively. Survival rate was 86.2%. For the 12 months post- vs. pre-implant, HFHs decreased by 62% (0.60 vs. 1.55 events/patient-year; hazard ratio 0.38, 95% CI 0.31-0.48; P < 0.0001). After 12 months, mean PAP decreased by 5.1 ± 7.4 mmHg, Kansas City Cardiomyopathy Questionnaire (KCCQ) overall/clinical summary scores increased from 47.0 ± 24.0/51.2 ± 24.8 to 60.5 ± 24.3/62.4 ± 24.1 (P < 0.0001), and the 9-item Patient Health Questionnaire sum score improved from 8.7 ± 5.9 to 6.3 ± 5.1 (P < 0.0001). Haemodynamic-guided HF management proved feasible and safe in the health systems of Germany, The Netherlands, and Ireland. Physician-directed treatment modifications based on remotely obtained PAP values were associated with fewer HFH, sustainable PAP decreases, marked KCCQ improvements, and remission of depressive symptoms.

Rationale and design of the CardioMEMS Post-Market Multinational Clinical Study: COAST.

AimsChronic heart failure reduces quality and quantity of life and is expensive for healthcare systems. Medical treatment relies on guideline‐directed therapy, but clinical follow‐up and remote management is highly variable and poorly effective. New remote management strategies are needed to maintain clinical stability and avoid hospitalizations for acute decompensation.Methods and resultsThe CardioMEMS Post‐Market Study is a prospective, international, single‐arm, multicentre, open‐label study (NCT02954341) designed to examine the feasibility of haemodynamic guided heart failure management using a small pressure sensor permanently implanted in the pulmonary artery (PA). Daily uploaded PA pressures will be reviewed weekly to remotely guide medical management of patients with persistent NYHA Class III symptoms at baseline and a hospitalization in the prior 12 months. The study will enrol up to 800 patients from 85 sites across the United Kingdom, Europe, and Australia. The primary safety endpoint will assess device or system‐related complications or sensor failures after 2 years of follow‐up. Efficacy will be estimated after 1 year of follow‐up comparing HF hospitalization rates before and after sensor implantation. Observational endpoints will include mortality, patient, and investigator monitoring compliance, PA pressure changes, quality of life, and several pre‐defined subgroup analyses.ConclusionsThe CardioMEMS Post‐Market Study will investigate the generalizability of remote haemodynamic guided HF management in a number of national settings. The results may support the more widespread implementation of this novel clinical management approach.

Usefulness of Noninvasively Measured Pulse Amplitude Changes During the Valsalva Maneuver to Identify Hospitalized Heart Failure Patients at Risk of 30-Day Heart Failure Events (from the PRESSURE-HF Study)

The pulse amplitude ratio (PAR), the ratio of pulse pressure at the end of the Valsalva maneuver to before the onset, correlates with cardiac filling pressure. We have developed a handheld device that uses finger photoplethysmography to measure PAR and estimate left ventricular end diastolic pressure (LVEDP). Patients hospitalized with heart failure (HF) performed three 10-second trials of a standardized Valsalva maneuver (at 20 mm Hg measured via pressure transducer), while photoplethysmography waveforms were recorded, at admission and discharge. Combined primary outcome was 30-day HF hospitalization, intravenous diuresis, or death. Fifty-two subjects had discharge PAR testing; 12 met the primary outcome. Median PAR on admission was 0.55 (interquartile range: 0.40 to 0.70, n = 48) and on discharge was 0.50 (interquartile range: 0.36 to 0.69). Mean PAR-estimated LVEDP was significantly higher in subjects that had an event (20.2 vs 16.9 mm Hg, p = 0.043). Subjects with PAR-estimated LVEDP >19.5 mm Hg had an event rate hazard ratio of 4.57 (95% confidence interval 1.37, 15.19, p = 0.013) compared with patients with LVEDP 19.5 mm Hg or below, with significantly lower 30-day event-free survival (log-rank p = 0.006). In conclusion, noninvasively estimated LVEDP using the pulse amplitude response to a Valsalva maneuver in patients hospitalized for HF changes with diuresis and identifies patients at high risk for 30-day HF events. Detection of elevated filling pressures before hospital discharge may be useful in guiding HF management to reduce HF events.

CardioMEMS, the real progress in heart failure home monitoring.

The burden of hospitalizations driven by exacerbation of acute heart failure remains unacceptably high. The associated use of hospital resources drives increasing patient, caregiver, and economic costs. Noninvasive telemedical systems investigated in randomized controlled trials have failed to demonstrate to reduce hospitalization rates probably because of the indirect (non-linear) relationship of the measured biological signals with the patient congestion status. Instead, there is increasing evidence that direct measure of intracardiac and pulmonary artery pressure can effectively guide heart failure management and reduce hospitalizations. Early studies adopting implantable hemodynamic monitors in the right heart unveiled the potential of pressure-based heart failure management, whereas subsequent investigations showed the powerful preemptive approach for heart failure exacerbations. One large randomized trial (CHAMPION) proved that a direct pulmonary pressure monitor system (CardioMEMS) substantially reduced heart failure hospitalizations in subjects randomized to active pulmonary pressure-guided management. The system monitoring safety and efficacy were also excellent. The study proved that early management in response to increased pulmonary pressure is able to provide the most effective therapeutic intervention to prevent heart failure exacerbations.

Differences in Swan-Ganz Hemodynamics from Catheterization Lab Insertion to the Cardiac Care Unit: A Prospective Study

Purpose Invasive hemodynamic monitoring with Swan-Ganz catheters (SGC) provides clinical information that can help guide heart failure management and inform decisions regarding advanced heart failure therapies. However, measurements in the cardiac catheterization laboratory (CCL) can potentially be affected by anxiety, stress, and colder temperatures. To address the magnitude of this effect, we investigated the magnitude of variation in hemodynamics between the CCL and the cardiac care unit (CCU). Methods We prospectively enrolled patients who underwent SGC placement in the CCL and then were moved to the cardiac care unit (CCU) for continuous hemodynamic monitoring. Hemodynamic measurements obtained in CCL were compared to on arrival to the CCU before the initiation of additional medical interventions. Results Data was obtained from 53 patients with heart failure [58.8 ± 13 years; 17% female; LVEF 20% ± 12%] who had leave-in SGCs placed since April 2018. Compared to the CCU, patients in the CCL were found to have higher biventricular filling pressures, systemic vascular resistance (p pulmonary vascular resistance (p Conclusion Invasive hemodynamic measurements obtained from patients with heart failure in the CCL are significantly worse than those obtained hours later in the CCU environment. In patients that have unfavorable hemodynamics in the CCL, there may be utility in reassessing parameters in an inpatient setting to optimize patient management.

How Dynamic are Hemodynamics?: Short-Term Changes in Hemodynamic Measures and Indices among Heart Failure Patients

Purpose Pulmonary arterial catheters (PAC) are valuable tools for guiding heart failure management and evaluating patients for advanced therapies. Although several hemodynamically-derived indices have prognostic value in patients with advanced heart failure, the short-term variance that can be seen in these measurements has not been well described. This study aimed to determine short-term variations in hemodynamic measurements and associated indices among heart failure patients. Methods Patients undergoing clinically-indicated PAC placement at our institution from April 2018 with serial hemodynamic measurements were prospectively recruited. Hemodynamics and clinical variables were collected at the time 0 and again at 24 hours. Hemodynamic indices frequently used to assess the right ventricle, including pulmonary artery pulsatility index (PAPi), right atrial pressure (RAP) to pulmonary capillary wedge pressure (PCWP) ratio, and transpulmonary gradient were also calculated for both time points. Results Data was available for 57 patients with an average of age 58.3 years. Compared to baseline measurements, 24-hour data revealed a significant reduction in RAP (-1.6 mmHg; p= Conclusion Our single-center experience with short-term hemodynamic measurements revealed improvement in filling pressures over 24 hours. Notably, in patients with initially elevated RAP, PAPi significantly improved. Such findings demonstrate that PAPi's utility as a risk prediction index must be considered in the context of its variability based on loading conditions, rather than as a static value.

Pulmonalarterieller Drucksensor zur ambulanten Beurteilung des ventrikulären Füllungsdrucks bei fortgeschrittener Herzinsuffizienz

Patients with advanced heart failure suffer from frequent hospitalizations. Noninvasive hemodynamic telemonitoring for assessment of pulmonary filling pressure has been shown to reduce hospitalizations. In this article, our experience with possible control intervals and the standardization of the follow-up care of hemodynamic telemonitoring is reported.A literature search and our own experience in the follow-up care concerning the implantable pulmonary artery pressure sensor for noninvasive hemodynamic telemonitoring in patients with advanced heart failure are presented.For standardized follow-up care of heart failure patients with hemodynamic monitoring a specialized team consisting of a heart failure nurse and heart failure physician is essential. These teams should ideally work based on a unique standard operating procedure (SOP) to ensure standardized control intervals and a standardized approach to classical hemodynamic changes. However, all therapeutic recommendations have to be prescribed by a physician and must be modified if individually appropriate.Optimized follow-up care for hemodynamically guided heart failure management requires the implementation of novel structures in the German health care system in order to transfer the clinical benefit from clinical trials into daily routine.

What is the Role of Cardiopulmonary Exercise Testing in Goal Directed Therapy of Heart Failure Patients Presenting with Dyspnea

Background Cardiopulmonary exercise testing (CPX) is a non-invasive tool to precisely define maximum exercise capacity with measurement of peak oxygen uptake (pVO2). Combined with other variables, CPX provides a comprehensive characterization of reserve capacity which can then guide the need for treatment. Purpose The purpose of this study was to evaluate findings in ambulatory heart failure patients undergoing CPX and assess heart failure severity/guide treatment. Methods A total of 96 patients were referred to the cardiology service for CPX testing at a local community hospital during the years of 2016 and 2017. All CPX data and results were interpreted/reported by the heart failure medical director. Results Of the 96 patients who underwent CPX testing, 50 were found to have cardio-metabolic impairment due to heart failure (HF). Of these patients, the mean findings were: age 69, BMI 28.6, mean ejection fraction 36.6%, and 35% female. CPX results were notable for average pVO2 of 1.24 L/min (65.85%), average weight adjusted VO2 of 14.56 mL/kg/min (67.76%) and average VE/VCO2 slope of 36.6. 22% of patients were referred to cardiac rehabilitation. 8% were referred to an LVAD/transplant program, while 32% received optimization of medication regimen in the hospital HF clinic. Primary all-cause of dyspnea was due to deconditioning (22%) compared to cardiac (30.2%), pulmonary (11.45%) or mixed (27.1%) etiology. 2 patients required the use of inotropes, 4 were readmitted for HF exacerbation and there was 1 recorded death. A total of 40 patients who did not follow up with a provider in our EMR were lost to follow-up. Discussion Using CPX we were able to capture the patients presenting with persistent dyspnea with a component of cardio-metabolic etiology. These patients were then referred to our HF program for further management based on symptomatology and response to therapy. Options for management included the addition/titration of evidence-based HF therapy, cardiac rehab, referral to stage D heart failure centers for evaluation of advanced therapies or intervention. We hypothesize that CPX is a valuable tool to discriminate HF severity in ambulatory patients in a community HF setting. Future directions include using CPX to guide HF management in NYHA I-III patients in HFrEF and HFpEF, and risk prediction of stage C patients based on the ability to identify patients for Stage D intervention versus optimization of medication regimen.