CardioMEMS Heart Failure System Research Articles

Heart failure hospitalization reduction and long-term safety with remote pulmonary artery pressure monitoring: results of the CardioMEMS HF System OUS Post-Market Study

Abstract Background Heart failure (HF) is increasing in prevalence and is responsible for frequent hospitalization and readmissions, despite current guideline recommended therapies. Hemodynamic guided HF management using frequently remotely obtained pulmonary artery (PA) pressure information using a permanently implanted PA sensor (CardioMEMSTM HF System, Abbott) consistently reduced HF hospitalizations (HFH) in multiple healthcare settings. The safety and efficacy of the CardioMEMS HF System has been shown previously in several clinical studies, which reported significant reductions in HFH compared to a control (CHAMPION: 33%, 18M; GUIDE-HF: 28%, 1 yr; and MONITOR-HF: 44%, 1 yr) and longitudinally (MEMS-HF: 62%, 1 yr; and CardioMEMS US PAS: 57%, 1 yr) across varying health systems. Purpose The CardioMEMS HF System OUS Post-Market Study (COAST) aimed to evaluate the safety and effectiveness of hemodynamic guided HF management in patients with NYHA Class III HF in varying health systems across Europe and Australia. Methods COAST is a prospective, multi-centre, open-label clinical trial that consented 321 patients at 38 European and Australian centres. The primary endpoint is a combination of safety (freedom from DSRCs and freedom from pressure sensor failure at 2 years after implant) and efficacy endpoints (annualized HFH rate at 1-year vs the HFH rate in the year prior to enrolment). In this analysis we report these primary results of the study. Results Out of 321 consented patients, 17 subjects were withdrawn before implant, while the PA sensor was implanted successfully in 299 out of 304 patients who underwent the procedure (98.3% success rate). Seventy-three percent (73%) of the patients were male, the mean age was 68.4±11.7 years with ischemic cardiomyopathy in 45.4%. At baseline, all patients had NYHA Class III symptoms and an average EQ-5D-5L VAS score of 60.0±21.6. After 2 years follow-up there was 100% freedom from DSRCs and 99.7% freedom from pressure sensor failure. The annualized HFH rate after 1 year decreased by 69%, from 1.586 (pre-implant) to 0.488 (post-implant) (p<0.0001). The patient’s quality of life (EQ-5D-5L VAS) increased 8.1 units (68.2 ± 20.1, p=0.0008). Conclusion The COAST Study demonstrated that hemodynamic-guided remote HF management using PA pressure information is both safe and effective, with consistent implant safety and low risk for long-term sensor failure. At 1 year post implant, HFH were significantly reduced and quality of life improved. These results are also consistent with long-term clinical follow-up (2 yr) in other geographies with no late-stage adverse events or adverse events from sensor implant, demonstrating the generalizability of this type of hemodynamic-guided HF management.

Measurement inaccuracy reported via the Manufacturer and User Facility Device Experience database for an implantable pulmonary artery pressure sensor: recalibration direction and magnitude results

Abstract Introduction Remote monitoring using an implantable pulmonary artery pressure (PAP) sensor (CardioMEMS HF system) in patients with heart failure (HF) has been consistently shown to reduce HF hospitalizations [1]. The success of this approach relies on the accurate measurement of diastolic PAP (dPAP) over time to allow early interventions such as diuretic intensification [2]. However, it remains unclear how the measurement accuracy changes over time after the initial calibration at the time of device implantation. Purpose This study aims to identify measurement inaccuracy events and to quantify the magnitude and direction of required device recalibration for CardioMEMS devices as reported in a large-scale regulatory device database. Methods We used the publicly accessible Manufacturer and User Facility Device Experience (MAUDE) data maintained by the US Food and Drug Administration (FDA). The summary search was performed for the CardioMEMS pulmonary artery pressure sensor for the entire product life cycle from January 2009 to February 2024 [3,4]. The entries related to the measurement accuracy under ‘Device Problems’ categories were obtained. Tested accuracy was reported to have been within ±10mmHg of a reference pressure measurement throughout simulated use for 10 years [5]. Normal range for dPAP is ~8mmHg to 15mmHg [6]. Results A total of 2656 entries were obtained. Following categories were identified for the reported entries: device sensing problem (N=999, 38%); incorrect measurement (N=1349, 52%); incorrect measurement, inappropriate waveform (N=279, 11%), and incorrect, inadequate, or imprecise results or readings (N=29, 1%). After excluding 56 entries for missing information, 2600 entries were included for the analysis. A total of 1676 (64%) entries reported the need for recalibration of the CardioMEMS device. A mean PAP difference (defined as the difference of the mean PAP reference value measured at the time of recalibration minus the CardioMEMS reading obtained during the reference measurement) is shown in Figure 1. Compared to the reference pressure values at the time of recalibration, 488 (29%) of CardioMEMS readings were higher and 1188 (71%) were lower. The absolute recalibration pressure difference was 14.5 ± 9.3 mmHg (mean ± standard deviation, range 0.02-59.3 mmHg). The recalibration by more than 10 mmHg was reported in 1040 (40%) entries. Conclusions Suspected measurement inaccuracy with CardioMEMS device is not uncommon and often necessitate recalibration. Almost one-half (40%) of the recalibrations required more than 10 mmHg correction. These results should inform clinicians to consider recalibration along the course of CardioMEMS monitoring if there is discordance between clinical assessment and the values from the device.Figure 1.Figure 2

Effects of sodium-glucose cotransporter 2 inhibitors on pulmonary hemodynamics in chronic heart failure patients with a pulmonary artery pressure sensor

Abstract Background Approximately 50% of patients with chronic heart failure (HF), either with preserved or reduced left ventricular ejection fraction (LVEF), have secondary pulmonary hypertension, which results in poorer prognosis. In previous studies, sodium-glucose cotransporter 2 inhibitors (SGLT2i) have shown a reduction in cardiovascular death, HF hospitalization and pulmonary artery pressure (PAP) in patients with HF, regardless of LVEF, but exact mechanisms remain unclear. Purpose The main objective of this study is to analyse effects of SGLT2i on PAP in patients with chronic HF followed by a PAP sensor (CardioMEMS HF system). The secondary objective is to analyse effects in subgroups of LVEF. Methods We included chronic HF patients (regardless of LVEF) with previously implanted a PAP sensor, from July 2019 to February 2023. SGLT2i had been added in fourth position in patients with reduced LVEF, since they were previously on optimal HF treatment as chronic patients. Changes in PAP, renal function and N-terminal pro B-type natriuretic peptide (NTproBNP) were compared between two periods of time: "30 days before" and "30 days after" SGLT2i initiation. Patients were then classified in two groups: group 1 (LVEF ≤40%) and group 2 (LVEF >40%) and repeated same analyses. Results Overall, 61 patients were screened, and 17 finally were included, mean age 71.7 ± 9.6 years, 64.7% were men, mean LVEF was 49.4 ± 17.5%, 23.5% had ischaemic aetiology and 64.7% were in NYHA class III (Table 1). There were more men in group 1 than in group 2 (p=0.043), without other differences in basal characteristics between groups (Table 1). Dapagliflozin (10mg daily) was initiated in 14 patients (82.4%), 5 from group 1 and 9 from group 2 (p=1.000), and empagliflozin (10mg daily) in 3 patients (17.6%), 1 from group 1 and 2 from group 2 (p=1.000). Before SGLT2i, mean diastolic PAP (dPAP) was 17.3 ± 5.6 mmHg and median NTproBNP was 2841.5 (289-10515) pg/mL. SGLT2i significantly reduced dPAP; average dPAP ("30 days after" period) was 1.5 mmHg lower (95% CI, 0.26-2.74; p=0.021) compared to "30 days before" period (Figure 1). SGLT2i also reduced systolic PAP (-2.2 mmHg), mean PAP (-1.7 mmHg), NTproBNP (-183 pg/mL) and creatinine (-0.2 mg/dL), but not statistically significant. SGLT2i reduced PAP, NTproBNP and creatinine too in group 1 (6 patients), but did not achieve statistical significance. Reductions were as well observed in group 2 (11 patients), and SGLT2i significantly reduced dPAP (-2.04 mmHg) (95% CI, 0.31-3.77; p=0.025). Conclusions In patients with chronic HF and a PAP sensor, SGLT2i, added to previous HF treatment, significantly reduced dPAP. PAP reductions were observed regardless LVEF, but results were more robust in patients with LVEF >40%.Figure 1

Assessing the impact of haemodynamic monitoring with CardioMEMS on heart failure patients: a cost-benefit analysis.

The objective of this study was to perform a cost-benefit analysis of the CardioMEMS HF System (Abbott Laboratories, Abbott Park, IL, USA) in a heart failure (HF) clinic in Spain by evaluating the real-time remote monitoring of pulmonary artery pressures, which has been shown to reduce HF-related hospitalizations and improve the quality of life for selected HF patients. Particularly, the study aimed to determine the value of CardioMEMS in Southern Europe, where healthcare costs are significantly lower and its effectiveness remains uncertain. This single-centre study enrolled all consecutive HF patients (N=43) who had been implanted with a pulmonary artery pressure sensor (CardioMEMS HF System); 48.8% were females, aged 75.5±7.0years, with both reduced and preserved left ventricular ejection fraction; 67.4% of them were in New York Heart Association Class III. The number of HF hospitalizations in the year before and the year after the sensor implantation was compared. Quality-adjusted life years gained based on a literature review of previous studies were calculated. The rate of HF hospitalizations was significantly lower at 1year compared with the year before CardioMEMS implantation (0.25 vs. 1.10 events/patient-year, hazard ratio 0.22, P=0.001). At the end of the first year, the usual management outperformed the CardioMEMS HF System. By the end of the second year, the CardioMEMS system is estimated to reduce costs compared with usual management (net benefits of €346). Based on the results, we suggest that remote monitoring of pulmonary artery pressure with the CardioMEMS HF System represents a midterm and long-term efficient strategy in a healthcare setting in Southern Europe.

A profile on the CardioMEMS HF system in the management of patients with early stages of heart failure: an update

ABSTRACT Introduction Over the past decade, there have been noteworthy advances in the evaluation and treatment of heart failure (HF). Despite an improved understanding of this chronic disease, HF is still one of the leading causes of morbidity and mortality in the United States and worldwide. Decompensation and rehospitalization of HF patients remain an integral problem in disease management, with significant economic implications. Remote monitoring systems have been developed to detect HF decompensation early and address it before hospitalization. The CardioMEMS HF system is a wireless pulmonary artery (PA) monitoring system that detects changes in PA pressure and transmits data to the healthcare provider. As changes in PA pressures occur early during HF decompensation, the CardioMEMS HF system allows providers to institute timely changes in HF medical therapies to alter the course of the decompensation. The use of the CardioMEMS HF system has been shown to reduce HF hospitalization and improve quality of life. Areas Covered This review will focus on the available data supporting the expanded utilization of the CardioMEMS system in patients with HF. Expert Opinion The CardioMEMS HF system is a relatively safe and cost-effective device that reduces the incidence of HF hospitalization and qualifies as intermediate-to-high value medical care.

Cost-Effectiveness of Remote Cardiac Monitoring With the CardioMEMS Heart Failure System: A Systematic Review.

Heart Failure (HF) imposes a relevant burden and a considerable health concern, with high prevalence and mortality rates. This study was conducted to assess the cost-effectiveness of remote cardiac monitoring with the CardioMEMS Heart Failure System. In the present systematic review, several scholarly databases were searched and updated from inception up to September 20, 2022. The objective of the present review was formulated according to the patient/population, intervention, comparison and outcomes format. Mortality rate, hospitalization rate, quality-adjusted life year (QALY), total costs, and the incremental cost-effectiveness ratio regarding the use of the CardioMEMS System were the key outcomes of the present study. The quality of included studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS) checklist. Finally, 5 articles were retained and analyzed in the present systematic review. All studies employed the Markov and decision tree models. Results show that the CardioMEMS system reduced mortality and hospitalization rate and created a higher QALY. In all selected countries the CardioMEMS method is a more expensive method than the standard of care (SoC), with the highest cost in the United States (US) ($201,437) and the lowest cost in the United Kingdom ($25,963), respectively. the highest willingness to pay in the US and the lowest in Italy ($100,000 and $33,000 per QALY), respectively. Results showed that the most cost per QALY for the CardioMEMS system was in the US and the lowest was in the Netherlands ($46,622 and $26,615 per QALY), respectively. In all selected countries, CardioMEMS is a cost-effective method for monitoring and managing pulmonary artery pressures in HF patients. Strategies such as CardioMEMS, which decrease the rate of hospitalization, are likely to be only more cost-effective in the future.

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.

Long Term Safety and Outcomes Utilizing the CardioMEMS Device in Patients with Pulmonary Arterial Hypertension

<h3>Purpose</h3> Baseline and periodic hemodynamic monitoring of pulmonary artery pressures using right heart catheterization (RHC) is recommended for initiating and titrating pulmonary arterial hypertension (PAH) therapies as well as for prognostication. The CardioMEMS HF System is an ambulatory implantable hemodynamic monitor, previously only used in patients with left heart failure (HF). In this study, we describe the long-term safety and outcomes using the CardioMEMS device in PAH patients implanted as a part of an investigational pilot study. <h3>Methods</h3> 23 PAH patients between the ages of 31-80 years, were implanted with CardioMEMS device as a part of an investigational pilot study (VITA contract HHSN268201400008C) between 08/2014 - 09/2018. 3 patients were lost to follow-up. Complete follow up data was available for 20 patients who were included in this analysis. <h3>Results</h3> 85% of the PAH patients were female, with a median post-implant follow-up period of 58.5 months. The number of right heart catheterization (RHC) prior to the device implant was 4.37 per patient year, while only 1.99 RHC per patient year were done post implant. In long term follow up there were no significant device related adverse events and all devices remain functional. 8 patients did require RHC for recalibration of the device. 12 patients are still undergoing active monitoring. Of the remaining patients, 1 was enrolled in hospice, 4 patients died from progression of PAH, 1 patient died from malignancy; 1 from end-stage cirrhosis. There was a total of 13 HF hospitalizations between these 20 patients over 3 to 7 year follow-up based on the time of implant. <h3>Conclusion</h3> The CardioMEMS device has previously been reported to reduce hospitalizations in patients with left sided heart failure. Based on our study, deployment of the device was safe in PAH patients with no long-term device related complications. It reduced the number of follow-up invasive RHC by more than 50%. Larger prospective studies are warranted before widespread use of the device for monitoring PA pressures in PAH patients.

Mechanical support for the failing single ventricle after Fontan

Mechanical support for the failing single ventricle after Fontan

Quantification of device-related event reports associated with the CardioMEMS Heart Failure System

Abstract Introduction The CardioMEMS (Abbott) is an implantable pulmonary artery pressure monitor for heart failure patients approved by the United States Food and Drug Administration (FDA) based on the CHAMPION trial reporting a reduction in the composite outcome of heart failure hospitalizations (HFH) and all-cause mortality. The result was driven by reduction in HFH; there was no benefit on mortality. While CardioMEMS was approved by the FDA in May 2014 and received Conformitè Europënne (CE) Mark approval in December 2014, the FDA review found preferential attention towards patients in the treatment arm that may have biased results. The FDA-mandated industry-sponsored post-marketing study identified 5 device-related complications in a 1,200-patient cohort from September 2014 to October 2017. A separate review of adverse events reported to the FDA during a similar timeframe from May 2014 to May 2017 identified 155 instances of injury or death. As worldwide implantation rates of CardioMEMS have increased since 2017 to roughly 20,000, we updated device-related events reported to the FDA to aid in understanding its current real-world safety profile. Methods The FDA mandates reporting of all medical device-related events to the Manufacturer and User Facility Device Experience (MAUDE) database, a passive surveillance system. We queried all available reports from May 28, 2014 to November 28, 2020 using the unique product code for CardioMEMS (“MOM”). Almost all reports (96%) contained a narrative description, which was used to enumerate adverse events. Results A total of 2,861 MAUDE reports have been filed for CardioMEMS in the reporting period, increasing from an average of 38 reports per 6-month period from May 2014 to May 2017 to an average of 149 reports per 6-month period afterwards (Figure 1). The majority reported inaccurate measurements, which required replacement of the external unit, repeat non-invasive testing, or repeat catheterization to resolve (Table). There were 169 (5.9%) patient deaths reported; most commonly reported non-fatal safety events included hemoptysis, heart failure exacerbation, and significant bleeding at the groin site (Table 1). Conclusion We found an increased number of adverse events associated with CardioMEMS in the last 3 years compared to the first 3 years, partially coinciding with increased use. Safety of CardioMEMS should be considered along with the lack of evidence of benefit on all-cause mortality from clinical trials. MAUDE has the known limitation of incomplete adverse event reporting, thus actual adverse event rates are certainly higher. Another limitation is lack of an exact denominator as number of implantations annually is not publicly available. Our analysis demonstrates risks associated with CardioMEMS implantation that are increasing in number. These data can more accurately inform discussions regarding risks and benefits between patients, physicians, and policymakers when considering CardioMEMS. Funding Acknowledgement Type of funding sources: None. FigureTable

Pulmonary Artery Pressure Monitoring Effectively Guides Management to Reduce Heart Failure Hospitalizations in Obesity

ObjectivesThis study sought to determine the impact of therapy guided by pulmonary artery (PA) pressure monitoring in patients with heart failure (HF) and obesity. BackgroundObesity is prevalent in HF and associated with volume retention, but it complicates clinical assessment of congestion. MethodsThe CardioMEMS Post Approval Study was a prospective, multicenter, open-label trial in 1,200 patients with New York Heart Association functional class III HF and prior HF hospitalization (HFH) within 12 months. Patients with a body mass index (BMI) >35 kg/m2 were required to have a chest circumference <65 inches. Therapy was guided by PA pressure monitoring at sites, and HFHs were adjudicated 1 year before implantation and throughout follow-up. This analysis stratified patients according to ejection fraction (EF) <40% or ≥40% and by BMI <35 kg/m2 or ≥35 kg/m2. ResultsBaseline PA diastolic pressure was higher in patients with BMI ≥35 kg/m2 regardless of EF, but all PA pressures were reduced at 12 months in each cohort (P < 0.0001). HFH rate was reduced by >50% in both cohorts for EF <40% (BMI <35 kg/m2 [HR: 0.48; 95% CI: 0.41-0.55] and ≥35 kg/m2 [HR: 0.40; 95% CI: 0.31-0.53]) and EF ≥40% (BMI <35 kg/m2 [HR: 0.42; 95% CI: 0.35-0.52] and ≥35 kg/m2 [HR: 0.34; 95% CI: 0.25-0.45]; P < 0.0001). There was a nonsignificant trend toward greater reduction with more obesity. The all-cause hospitalization rate was also significantly reduced during monitoring (P < 0.01). ConclusionsManagement guided by PA pressure monitoring effectively reduced pressures, HFH, and all-cause hospitalization in patients with obesity regardless of EF. (CardioMEMS HF System Post Approval Study; NCT02279888)

Improving the monitoring of chronic heart failure in Argentina: is the implantable pulmonary artery pressure with CardioMEMS Heart Failure System cost-effective?

BackgroundThe CardioMEMS® sensor is a wireless pulmonary artery pressure device used for monitoring symptomatic heart failure (HF). The use of CardioMEMS was associated with a reduction of hospitalizations of HF patients, but the acquisition cost could be high in low-and-middle income countries. Evidence of cost-effectiveness is needed to help decision-makers to allocate resources according to “value for money”. This study is aimed at estimating the cost-effectiveness of CardioMEMS used in HF patients from the third-party payer perspective -Social Security (SS) and Private Sector (PS)- in Argentina.MethodsA Markov model was developed to estimate the cost-effectiveness of CardioMEMS versus usual medical care over a lifetime horizon. The model was applied to a hypothetical population of patients with HF functional class III with at least one hospitalization in the previous 12 months. The main outcome was the incremental cost-effectiveness ratio (ICER). To populate the model we retrieved clinical, epidemiological and utility parameters from the literature, whilst direct medical costs were estimated through a micro-costing approach (exchange rate USD 1 = ARS 76.95). Uncertainties in all parameters were assessed by deterministic, probabilistic and scenario sensitivity analysis.ResultsCompared with the usual medical care, CardioMEMS increased quality-adjusted life years (QALY) by 0.37 and increased costs per patient by ARS 1,081,703 for SS and ARS 919,051 for PS. The resultant ICER was ARS 2,937,756 per QALY and ARS 2,496,015 per QALY for SS and PS, respectively. ICER was most sensitive to the hazard ratio of HF hospital admission and the acquisition price of CardioMEMS. The probability that CardioMEMS is cost-effective at one (ARS 700,473), three (ARS 2,101,419,) and five (ARS 3,502,363) Gross Domestic Product per capita is 0.6, 17.9 and 64.1% for SS and 5.4, 33.3 and 73.2% for PS.ConclusionsCardioMEMS was more effective and more costly than usual care in class III HF patients. Since in Argentina there is no current explicit threshold, the final decision to determine its cost-effectiveness will depend on the willingness-to-pay for QALYs in each health subsector.

Morning pulmonary artery pressure measurements by CardioMEMS are most stable and recommended forpressure trends monitoring.

AimsThe CardioMEMS HF system is used to measure pulmonary artery (PA) pressures of patients with heart failure (HF). The goal of this study was to determine the impact of time in the daily PA pressure measurements, considering variance and influence of circadian rhythms on cardiovascular pathophysiology.Methods and resultsThe study included 10 patients with HF with reduced ejection fraction (LVEF < 40%; New York Heart Association class III). Individual daily PA pressures were obtained by CardioMEMS sensors, per protocol, measured up to six times throughout the day, for a period of 5 days. Differences between variation of morning versus evening PA pressures were compared with Wilcoxon signed-rank test.Mean PA pressures (mPAP) increased from a morning value of 19.1 ± 2 mm Hg (8 am; mean ± standard error of the mean [SEM]) to 21.3 ± 2 mm Hg late in the evening (11 pm; mean ± SEM). Over the course of 5 days, evening mPAP exhibited a significantly higher median coefficient of variation than morning mPAP (14.9 (interquartile range [IQR] 7.6–21.0) and 7.0 (IQR 5.0–12.8) respectively; p = 0.01). The same daily pattern of pressure variability was observed in diastolic (p = 0.01) and systolic (p = 0.04) pressures, with diastolic pressures being more variable than systolic at all time points.ConclusionsMorning PA pressure measurements yield more stable values for observing PA trends. Patients should thus be advised to consistently perform their daily PA pressure measurements early in the morning. This will improve reliability and interpretation of the CardioMEMS management, indicating true alterations in the patient’s health status, rather than time-of-day-dependent variations.Supplementary InformationThe online version of this article (10.1007/s12471-021-01590-7) contains supplementary material, which is available to authorized users.

“The Road Not Taken": Successful Use of CardioMEMS to Optimize a Patient in Stage D Heart Failure

Introduction Pulmonary artery (PA) pressure monitoring via the CardioMEMS HF System is currently indicated for those with New York Heart Association (NYHA) Class III heart failure. However, the use of CardioMEMS in those with NYHA Class IV heart failure is less understood. Case Report 44-year old African American male with history of NYHA Class IIIb-IV, Stage D heart failure with reduced ejection fraction secondary to left ventricular noncompaction with recurrent severe mitral regurgitation (MR) despite successful transcatheter mitral-leaflet approximation with the MitraClip device, persistent atrial fibrillation status-post atrioventricular node ablation and cardiac resynchronization therapy (CRT) upgrade presented with frequent hospitalizations for acute decompensated heart failure (HF). He continued to have severe biventricular failure with left ventricular systolic function of 20% and left ventricular internal diameter in diastole of 8.1 cm. Despite medical optimization, MitraClip placement and CRT device implantation, the patient continued to have recurrent HF exacerbations with a total of six hospital admissions, two of which required prolonged intensive care unit stay for cardiogenic shock. He was not considered a candidate for left ventricular assist device due to chronic right sided heart failure. With history of active marijuana use, evaluation for cardiac transplantation was not an immediate option at our center and was deferred. The decision was made to place a CardioMEMS device to aid with assessment of volume status and to help prevent further hospitalizations. After placement of his CardioMEMs device, the patient had pulmonary artery diastolic pressure (PADP) readings ranging from 23-31 mmHg. Six months post implant, with frequent adjustments to his medical regimen, the patient has had no further emergency room visits or hospitalizations. His PADP improved to the range of 18-20 mmHg and he is currently undergoing evaluation for heart transplantation. Summary There is adequate data available that suggest CardioMEMS device reduces hospitalizations in those with NYHA Class III heart failure. Our case suggests that CardioMEMS may be safe and appropriate to aid in management of patients with more severe NYHA Class IIIb/IV heart failure. Future studies are necessary to determine the safety and utility of using CardioMEMS in this population.

CardioMEMS: where we are and where can we go?

The prevalence of heart failure (HF) has been on the rise with associated increase in hospitalizations, morbidity and mortality. These hospitalizations have led to increasingly more cost on and decreased quality of life for patients. CardioMEMS is one of the newer devices designed to help tackle this issue by allowing for better monitoring of HF patients. This device also allows for accurate recording of pulmonary artery pressures (PAPs) and has also been applied in various other areas, such as aneurysmal tears, for monitoring pressures. In this manuscript we will review the current state of CardioMEMS HF system and investigate some of the other areas for its promising use in the field.

Monitoring Pulmonary Arterial Hypertension Using an Implantable Hemodynamic Sensor

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. 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. 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 1month postimplant using trends of CardioMEMS HF data, coupled with significant NYHA class and quality of life improvements within 1 year. 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.

Hemodynamic-GUIDEd management of Heart Failure (GUIDE-HF)

BackgroundHemodynamic-guided heart failure (HF) management using pulmonary artery (PA) pressures reduces HF hospitalizations (HFHs) in previously hospitalized HF patients with New York Heart Association (NYHA) class III symptoms. It remains uncertain whether this approach reduces not only HFHs but all-cause mortality and if benefits extend to patients with NYHA class II and IV HF or to those symptomatic patients with elevated natriuretic peptides without recent HFH. MethodsGUIDE-HF is a prospective trial with 2 arms enrolling patients with HF regardless of ejection fraction (EF). The randomized arm is a single-blind, randomized, controlled trial of PA pressure-guided therapy in NYHA class II-IV patients (n = 1,000) with either a previous HFH or elevated natriuretic peptides (B-type natriuretic peptide/NT-pro–B-type natriuretic peptide). All consenting subjects will receive an implantable PA pressure sensor (CardioMEMS HF System) followed by randomization to either a treatment group, managed with provider remote access to the hemodynamic data, or a control group, managed without provider access to these data. Subjects in the control group will receive scheduled, scripted, sham contacts from the study team to maintain blinding as to their study group assignment. The primary study end point is the composite of cumulative HF events and all-cause mortality at 12 months. Secondary end points include quality-of-life and functional assessments. The single arm of the trial is an observational arm in which NYHA class III patients (n = 2,600) with either a previous HFH or elevated natriuretic peptides (but no recent HFH) will be implanted with a PA pressure sensor and observed for occurrence of the primary composite end point of cumulative HF events and mortality at 12 months. This arm will test the hypothesis that hemodynamic-guided care is similarly effective in HF patients enrolled on the basis of elevated natriuretic peptide levels but no recent HFH and those with a recent HFH. ConclusionsGUIDE-HF is the largest clinical trial of hemodynamic-guided HF management across a broad population of HF patients, with a study design and sample size adequate to examine survival, cumulative HF events, quality of life, and functional capacity.

An update on the CardioMEMS pulmonary artery pressure sensor.

Heart failure (HF) is one of the most important healthcare issues due to its prevalence, high morbidity and mortality, as well as its economic burden. A shift in the healthcare model towards reducing inpatient hospitalizations might have a significant impact on HF-related costs and quality of life. Recently, wireless monitoring has begun to be an essential part of the management in the patient with HF. The CardioMEMS HF system is one of the best examples pertaining to the success in this field. This article will discuss the CardioMEMS HF system and the rationale behind its development.

Ambulatory Hemodynamic Monitoring Strategy for Heart Failure Management Reduces Utilization of Emergency Room Services

Background: Ambulatory hemodynamic monitoring through the St. Jude Medical CardioMEMS™ HF System allows for assessment of pulmonary artery (PA) pressures and heart rate. Although several remote monitoring strategies have been explored, the CHAMPION Trial highlights the significant effectiveness of using longitudinal PA pressure guided heart failure (HF) management. This is the first and only FDA-approved monitoring strategy shown to significantly reduce HF hospital admissions and improve quality of life in NYHA class III patients. Objective: To examine whether management strategy using ambulatory hemodynamic monitoring through the CardioMEMS HF system reduced Emergency Department (ED) visits. Methods: A retrospective chart review of patients implanted with CardioMEMS HF system from March 30, 2015 to March 6, 2017 was performed. We examined ED visit event rates over the 1 year prior to implant compared with ED visits post implant. An ED visit was defined as a patient arriving at an ED within the health system and being discharged from the ED or arriving at the ED and being admitted as an observation stay for monitoring. Patients who were admitted as inpatients were not included. Patients were followed post implant until death, heart transplant, or VAD implant. Poisson regression was used to compare pre-implant event rates to post-implant event rates. Results: From 3/30/15 to 3/6/17, 52 patients were implanted. Average age at time of implant was 65 ± 14 y, 30 (58%) of the patients were male and 35 (67%) of the patients had an LVEF < 40% (Table 1). ED visits were significantly reduced in these 52 patients (Fig. 1). In the 1 year prior to implant, 80 ED visits occurred resulting in an average of 0.76 events per patient per 180 days compared with 34 ED visits in the post-implant phase resulting in an average of 0.52 events per patient per 180 days, P = .04 (Fig. 1.) Discussion: Utilization of remote hemodynamic monitoring via the CardioMEMS HF system in monitoring PA pressures is statistically significant in reducing ED visits in our health system.Table 1Baseline Demographics (Pre-Implant)IndicatorFreq (%); Mean+/−STDTotal implants52Age at implant64.6+/−14.2 (28–86)Male30 (57.7%)Race: Caucasian42 (80.8%)Height (cm)171.7+/−9.5 (152–190.5)Weight (kg)96.6+/−18.8 (57–134)BMI32.7+/−6 (20.9–45.4)LVEF32.1+/−17.6 (0.2–65)LVEF 40% or greater17 (32.7%)Laboratory and hemodynamic analysis Systolic blood pressure Diastolic blood pressure Heart rate (beats/min) Pulmonary Artery Pressure (mean) Serum creatinine (mg/dL) (median [Q1-Q3]) CRT/CRT-D ICD implant117.3+/−12.9 (91–142) 68.7+/−9.1 (52–84) 75.6+/−13.3 (50–103) 27.4+/−7.9 (13–43) 1.32 [1.02–1.62] 20 (38.5%) 19 (36.5%)Comorbidities Ischemic cardiomyopathy Hypertension Coronary artery disease Diabetes mellitus Atrial tachycardia flutter or fibrillation COPD Chronic kidney disease22 (42.3%) 34 (65.4%) 30 (57.7%) 24 (46.2%) 24 (46.2%) 15 (28.8%) 24 (46.2%)Drugs Angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers Beta-blocker Aldosterone antagonist Loop diuretic Hydralazine Nitrate37 (71.2%) 45 (86.5) 31 (59.6%) 52 (100%) 4 (7.7%) 12 (23.1%) Open table in a new tab

271 - Using Heart Rate Data From Ambulatory Hemodynamic Monitoring System in Heart Failure Management

Introduction: Standard use of ambulatory hemodynamic monitoring in heart failure (HF) management primarily involves adjustment of diuretics and vasodilator therapy. The CHAMPION Trial demonstrated the benefit of hemodynamic-guided management in symptomatic HF patients, which is highlighted in this case. Case: An 81-year-old white woman with ischemic cardiomyopathy, LVEF 27% and refractory NYHA III symptoms had paroxysmal AF (s/p 2 prior successful cardioversions and intolerant to antiarrhythmics) and biventricular pacemaker-defibrillator placement. She was on optimal evidence-based medical therapy and had been hospitalized 4 times in the past year for HF decompensation. We deemed her eligible for ambulatory hemodynamic monitoring to reduce HF hospitalizations and improve quality of life, and successfully implanted the CardioMEMS HF System. Post implant, hemodynamic data revealed elevated pulmonary artery pressures (PAPs) and heart rate (HR) and, based on evidence-based interventions, we continued intermittent adjustment of her medical regimen (Fig. 1). PAPs, HR and symptoms remained refractory despite this. Further evaluation unmasked uncontrolled paroxysmal AF. After an electrophysiology consult, she underwent successful atrioventricular node ablation using conventional catheter mapping techniques. Her hemodynamics and symptoms improved. Diuretics were down-titrated, with improvement in renal function and no rebound PAPs; she has not been admitted to the hospital for a HF decompensation event since. Discussion: This case illustrates the complicated nature of the syndrome of HF, and the adverse hemodynamic and clinical effects of AF. In “real world” experience, not every patient's hemodynamic pressures improve with a diuretic- or vasodilator-based strategy alone. We suspect that persisting with this restrained strategy may lead to adverse events, e.g., hypotension and renal dysfunction. This case highlights the use of HR, which is accessible data in the CardioMEMS HF System, as part of HF management strategy. This may help diagnose various mechanisms of HF decompensation. Interventions should also be expanded to include consideration of HR modulation strategies (eg, antiarrhythmics, ivabradine, optimal use of pacemakers and catheter-based ablation) when indicated. These proposed interventions, though individually proven to favorably impact HF management, need further investigation to be established as an adjunct to the current evidence-based strategy with ambulatory hemodynamic monitoring.