Pulmonary Artery Pressure Monitoring System Research Articles

Ambulatory factors influencing pulmonary artery pressure waveforms and implications for clinical practice.

CardioMEMS, a remote pulmonary artery pressure monitoring system, provides waveform patterns for the ambulatory heart failure patient. These waveforms provide significant insights into patient volume and clinical management. We aim to provide a foundation for understanding the determinants of waveform characteristics and provide practical examples illustrating how to interpret and integrate common scenario waveforms into clinical decision-making. A total of three groups of relevant scenarios were included namely (a) location and activity at time of waveform transmission, (b) impact of contemporary interventions, and (c) arrhythmias. We illustrate that waveform analysis can be individualized to each patient's care strategy in the appropriate clinical context to help guide clinical decision-making.

Understanding adherence to the CardioMEMS pulmonary artery pressure monitoring system for heart failure: A qualitative study

BackgroundThe CardioMEMS HF system is a remote monitoring device that allows patients to transmit pulmonary artery pressure readings to providers, who are alerted when pressures increase above the patient's normal threshold. ObjectivesThe purpose of this study was to gain a better understanding of patient adherence to the CardioMEMS system and to compare patients’ self-reported use of the system with actual adherence. MethodsWe conducted semi-structured interviews with patients who had a CardioMEMS device. Transcripts were analyzed using a combination of structural and process coding. ResultsPatients engaged with the CardioMEMS system in a reciprocal manner, continually learning from the feedback provided by the system. Self-concept influenced the way that patients adhere. ConclusionsPatients experience many benefits of the CardioMEMS system; however, it is not clear that these perceived or real benefits affect how a person adheres. Rather, our findings suggest that a person's self-concept may be a better predictor of adherence to telemonitoring systems.

P612Feasibility and safety of a wireless pulmonary artery pressure monitoring system in chronic porcine models of pulmonary hypertension

P612Feasibility and safety of a wireless pulmonary artery pressure monitoring system in chronic porcine models of pulmonary hypertension

Impact of Practice-Based Management of Pulmonary Artery Pressures in 2000 Patients Implanted With the CardioMEMS Sensor.

Elevated pulmonary artery (PA) pressures in patients with heart failure are associated with a high risk for hospitalization and mortality. Recent clinical trial evidence demonstrated a direct relationship between lowering remotely monitored PA pressures and heart failure hospitalization risk reduction with a novel implantable PA pressure monitoring system (CardioMEMS HF System, St. Jude Medical). This study examines PA pressure changes in the first 2000 US patients implanted in general practice use. Deidentified data from the remote monitoring Merlin.net (St. Jude Medical) database were used to examine PA pressure trends from the first consecutive 2000 patients with at least 6 months of follow-up. Changes in PA pressures were evaluated with an area under the curve methodology to estimate the total sum increase or decrease in pressures (mm Hg-day) during the follow-up period relative to the baseline pressure. As a reference, the PA pressure trends were compared with the historic CHAMPION clinical trial (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association [NYHA] Functional Class III Heart Failure Patients). The area under the curve results are presented as mean±2 SE, and P values comparing the area under the curve of the general-use cohort with outcomes in the CHAMPION trial were computed by the t test with equal variance. Patients were on average 70±12 years old; 60% were male; 34% had preserved ejection fraction; and patients were followed up for an average of 333±125 days. At implantation, the mean PA pressure for the general-use patients was 34.9±10.2 mm Hg compared with 31.3±10.9 mm Hg for CHAMPION treatment and 32.0±10.5 mm Hg for CHAMPION control groups. The general-use patients had an area under the curve of -32.8 mm Hg-day at the 1-month time mark, -156.2 mm Hg-day at the 3-month time mark, and -434.0 mm Hg-day after 6 months of hemodynamic guided care, which was significantly lower than the treatment group in the CHAMPION trial. Patients consistently transmitted pressure information with a median of 1.27 days between transmissions after 6 months. The first 2000 general-use patients managed with hemodynamic-guided heart failure care had higher PA pressures at baseline and experienced greater reduction in PA pressure over time compared with the pivotal CHAMPION clinical trial. These data demonstrate that general use of implantable hemodynamic technology in a nontrial setting leads to significant lowering of PA pressures.

Health Economic Impact of a Pulmonary Artery Pressure Sensor for Heart Failure Telemonitoring: A Dynamic Simulation.

Recently, a permanently implantable wireless system, designed to monitor and manage pulmonary artery (PA) pressures remotely, demonstrated significant reductions in heart failure (HF) hospitalizations in high-risk symptomatic patients, regardless of ejection fraction. The objectives of this study were to simulate the estimated clinical and economic impact in Germany of generalized use of this PA pressure monitoring system considering reductions of HF hospitalizations and the improvement in Quality of Life. Based on the Prospective Health Technology Assessment approach, we simulated the potential of the widespread application of PA pressure monitoring on the German healthcare system for the period 2009-2021. This healthcare economic simulation formulated input assumptions based on results from the CHAMPION Trial, a multicenter, prospective, randomized controlled U.S. trial that demonstrated a 37% reduction of hospitalizations in persistently symptomatic previous HF patients. Based on these results, an estimated 114,800 hospitalizations would expected to be avoided. This effect would potentially save an estimated €522 million, an equivalent of $575 million, during the entire simulation period. This healthcare economic modeling of the PA pressure monitoring system's impact demonstrates substantial clinical and economic benefits in the German healthcare system.

Interventions Linked to Decreased Heart Failure Hospitalizations During Ambulatory Pulmonary Artery Pressure Monitoring

ObjectivesThis study sought to analyze medical therapy data from the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in Class III Heart Failure) trial to determine which interventions were linked to decreases in heart failure (HF) hospitalizations during ambulatory pulmonary artery (PA) pressure-guided management. BackgroundElevated cardiac filling pressures, which increase the risk of hospitalizations and mortality, can be detected using an ambulatory PA pressure monitoring system before onset of symptomatic congestion allowing earlier intervention to prevent HF hospitalizations. MethodsThe CHAMPION trial was a randomized, controlled, single-blind study of 550 patients with New York Heart Association functional class III HF with a HF hospitalization in the prior year. All patients undergoing implantation of the ambulatory PA pressure monitoring system were randomized to the active monitoring group (PA pressure-guided HF management plus standard of care) or to the blind therapy group (HF management by standard clinical assessment), and followed for a minimum of 6 months. Medical therapy data were compared between groups to understand what interventions produced the significant reduction in HF hospitalizations in the active monitoring group. ResultsBoth groups had similar baseline medical therapy. After 6 months, the active monitoring group experienced a higher frequency of medications adjustments; significant increases in the doses of diuretics, vasodilators, and neurohormonal antagonists; targeted intensification of diuretics and vasodilators in patients with higher PA pressures; and preservation of renal function despite diuretic intensification. ConclusionsIncorporation of a PA pressure-guided treatment algorithm to decrease filling pressures led to targeted changes, particularly in diuretics and vasodilators, and was more effective in reducing HF hospitalizations than management of patient clinical signs or symptoms alone.

Abstract 19228: Cost-effectiveness of the CardioMems Implantable Pulmonary Artery Pressure Monitoring System in Patients With Chronic Heart Failure

Background: For management of heart failure, the value of the CardioMems device remains uncertain. We assessed the cost-effectiveness of the CardioMems device. Methods: We developed a Markov model to determine quality-adjusted life-years (QALYs), cost, and cost-effectiveness of patients with heart failure receiving CardioMems implantation compared to those with routine care. In the main case analysis, we modeled the intervention in the CHAMPION trial cohort, which included patients with NYHA Class III heart failure with a heart failure hospitalization within the past twelve months. We also performed subgroup analyses of patients with preserved ejection fraction or reduced ejection fraction, and a scenario analysis of a second cohort of patients from the CHARM trials with a previous heart failure hospitalization. We obtained event rates and utilities from published trial data; we used costs from literature estimates and Medicare payment data. The main case analysis was calibrated to the hospitalization and survival rates of the CHAMPION trial. Results: In the CHAMPION trial main case analysis, CardioMems reduced lifetime hospitalizations (2.37 versus 3.27), increased months of survival (67 versus 62), increased QALYs (2.66 versus 2.38) and increased costs ($171,132 versus $154,084), yielding a cost of $59,520 per QALY gained or $40,301 per life-year gained. The cost per QALY gained was $71,964 in patients with reduced ejection fraction compared to $34,899 in those with preserved ejection fraction. In less ill patients from the CHARM trials, which included patients with NYHA Class II heart failure, the device cost increased to $110,565 per QALY gained. If the device cost decreased from $17,500 in the main case analysis to $15,000, the intervention would cost less than $50,000 per QALY gained. The duration of effectiveness was initially assumed to be lifelong; if less than 29 months, CardioMems would cost more than $150,000 per QALY gained. Conclusion: The CardioMems device is cost-effective in populations similar to the CHAMPION trial, with a cost of less than $100,000 per QALY gained, if durability of device effectiveness is sustained. Post-marketing surveillance data on the device’s durability will further clarify its value.

Limitations of right heart catheterization in the diagnosis and risk stratification of patients with pulmonary hypertension related to left heart disease: Insights from a wireless pulmonary artery pressure monitoring system

Although right heart catheterization (RHC) remains the gold standard for assessment of hemodynamics in patients with known or suspected pulmonary hypertension (PH), there are significant limitations to this type of assessment. The current study evaluates the limitations of RHC in the diagnosis of left heart-related PH (World Health Organization group II) among patients enrolled in the CHAMPION trial and discusses insights into patient risk from home implantable hemodynamic monitor (IHM) data that were not identified at the time of the RHC procedure. The CHAMPION trial enrolled 550 New York Heart Association functional class III patients who had been hospitalized for heart failure (HF) in the previous year, regardless of left ventricular ejection fraction or etiology. Hemodynamic data obtained during baseline RHC were compared with IHM data obtained during the first week of home readings. HF hospitalization rates and mortality were analyzed to assess patient risk. The study population for this retrospective analysis comprised 537 patients with available IHM data. For 320 patients in the PHRHC group, home IHM data confirmed the RHC findings with similar mean pulmonary artery pressures obtained from both methods (36 mm Hg vs 36 mm Hg, p = 0.5066). However, of the 217 patients in the No PHRHC group, 106 patients (48.8%) exhibited PH based on the home IHM data (PHIHM group). The remaining 111 patients (51.2%) in the No PHRHC group had no evidence of PH on the IHM data (No PHIHM group). Patients in the No PHRHC/PHIHM group had significantly higher mean PA pressures on IHM than patients in the No PHRHC/No PHIHM group (31 mm Hg vs 18 mm Hg, p < 0.0001). Patients in the No PHRHC/No PHIHM group had significantly lower HF hospitalization rates than patients in the No PHRHC/PHIHM group (0.25 vs 0.49, incidence rate ratio = 0.51, 95% confidence interval = 0.33-0.77, p = 0.0007). Using only RHC, World Health Organization group II PH may be significantly under-diagnosed. In patients with left-sided HF and resting mean PA pressure ≤25 mm Hg during RHC, more frequent PA pressure monitoring using an IHM device can provide additional data for improved diagnosis and patient risk stratification compared with a single RHC alone.

Abstract 19396: Diuretic Use Guided by a Wireless Implanted Pulmonary Artery Pressure Monitoring System in NYHA Class III Heart Failure Patients: Observations from the CHAMPION Trial

Introduction: Optimal diuretic dosing strategies for the treatment of chronic heart failure (HF) have not been established. The range of effective diuretic doses varies widely from patient to patient and within patient from time to time. Knowledge of wirelessly measured Pulmonary Artery Pressure (w-PAP) can provide immediate feedback on treatment response and thus may help identify an optimal diuretic strategy. Methods: Retrospective analysis of CHAMPION trial data to determine if adjustments of diuretic therapy in response to w-PAP are associated with reduced HF hospitalization rates. Results: In the CHAMPION trial 270 patients were assigned to w-PAP and 280 to usual care (UC). At baseline w-PAP and UC groups were similar in percentage of patients receiving diuretics (91.9% and 94.2%) and diuretics doses. Over a 6 month follow up period loop diuretics were more frequently adjusted in the w-PAP than in the UC group (1267 vs. 498 times; p&lt;0.0001). In the w-PAP group 629 diuretic adjustments (49.8%) in 155 patients (57.4%) resulted from detection of increases in PAP and 107 diuretic changes (75.4%) in 46 patients (17%) occurred after detection of declining PAP. Compared to baseline, 6 months daily loop diuretic dose increased from 96.8 mg to 122.7 mg in the w-PAP group and 98.0 mg to 112.4 in the UC group. Despite more frequent diuretic adjustments in the w-PAP than in the UC group, mean daily loop diuretic dose changes were similar between groups (25.9 mg vs. 14.3 mg; p=0.1214). The 89 w-PAP patients with increased loop diuretic dose had a lower rate of HF hospitalizations than the 68 UC patients with similarly increased diuretic doses (0.32 vs. 0.70; p= 0.0014. In contrast HF hospitalization rates were similar in the 134 w-PAP and 173 UC patients without diuretic dose change (0.28 vs.0.27). Conclusions: Utilization of w-PAP permits physicians to effectively increase and decrease diuretic doses and reduce HF hospitalizations rates. Such adjustments in diuretic doses without knowledge of w-PAP are associated with a high 6-month rate of HF hospitalizations.

Heart Failure Hospitalizations are Reduced in Heart Failure Patients With Comorbid Pulmonary Hypertension Using a Wireless Implanted Pulmonary Artery Pressure Monitoring System

Pulmonary hypertension (PHTN) is common in both systolic and diastolic HF patients and is an independent predictor of adverse outcomes. PHTN in the setting of HF could be best managed by ongoing knowledge of pulmonary artery pressure (PAP) data.

Safety and accuracy of a wireless pulmonary artery pressure monitoring system in patients with heart failure

Implantable hemodynamic monitoring to guide heart failure (HF) therapy is a promising area of active research. The goal of this investigation was to evaluate the safety and technical performance of a novel wireless pulmonary artery pressure monitoring system in 17 patients with symptomatic HF. The monitoring system consists of a sensor, delivery catheter, interrogator, and home monitoring device. The HF sensor was implanted into a distal branch of the pulmonary artery. Pulmonary artery pressures were monitored using the external device, which powers the HF sensor and transmits the hemodynamic data from the patient's home to a secure Internet database. The accuracy of the system was assessed by comparison with standard right heart catheterization (RHC). The HF sensor was safely and successfully implanted in all patients. Agreement between the HF sensor and RHC for systolic, diastolic, and mean pulmonary artery pressures was excellent, with correlation coefficients of 0.94, 0.85, and 0.95, respectively (all P < .0001). Using Bland-Altman plots, the average differences for systolic, diastolic, and mean pulmonary artery pressures for the HF sensor vs RHC were -4.4 ± 0.3, 2.5 ± 1.0, and -0.8 ± 1.3 mm Hg, respectively. There were no serious device-related adverse events. A postmortem analysis of the HF sensor in a patient who died 12 months after implant demonstrated complete endothelialization and no evidence of thrombosis. This trial supports the safety and accuracy of this pulmonary artery pressure monitoring system in patients with HF and the conduct of randomized trials of implantable hemodynamic monitoring in HF, using this system.

CHAMPION Trial Rationale and Design: The Long-Term Safety and Clinical Efficacy of a Wireless Pulmonary Artery Pressure Monitoring System

Background Decompensated heart failure (HF) is associated with unacceptable morbidity and mortality risks. Recent implantable technology advancements allow frequent filling pressure monitoring and provide insight into HF pathophysiology and a new tool for HF management. Methods The CHAMPION trial is a prospective, multicenter, randomized, single-blind clinical trial testing the hypothesis that HF management guided by frequently assessed pulmonary artery pressures is superior to traditional methods. A total of 550 subjects with New York Heart Association (NYHA) functional class III HF were enrolled at 64 sites in the United States. All subjects received the CardioMEMS HF sensor as a permanent pulmonary artery implant and were randomized to the treatment or the control group before discharge. The treatment group received traditional HF management guided by hemodynamic information from the sensor. The control group received traditional HF disease management. Safety endpoints include freedom from device/system-related complications and freedom from HF sensor failure at 6 months. The efficacy endpoint is a reduction in the rate of HF-related hospitalizations in the treatment group versus the control group at 6 months. Conclusions The CHAMPION trial will investigate the safety and clinical efficacy of the CardioMEMS hemodynamic monitoring system and may establish this management strategy as a new paradigm for the medical management of patients with symptomatic HF.

Clinical trials update from the European Society of Cardiology Heart Failure Meeting 2010: TRIDENT 1, BENEFICIAL, CUPID, RFA‐HF, MUSIC, DUEL, handheld BNP, phrenic nerve stimulation, CHAMPION and CABG with CRT study

This article provides information and a commentary on key trials relevant to the pathophysiology, prevention and treatment of heart failure (HF) presented at the annual meeting of the Heart Failure Association of the European Society of Cardiology held in Berlin. Unpublished reports should be considered as preliminary, since analyses may change in the final publication. Tonapofylline failed to show efficacy and was associated with an approximately 1% increased risk of seizures in patients with acute decompensated heart failure (ADHF) and renal dysfunction in TRIDENT. Results from BENEFICIAL do not support the use of alagebrium, an advanced glycation end‐product breaker, in clinically stable patients with relatively mild HF symptoms. CUPID showed encouraging preliminary results for augmentation of SERCA2a enzyme activity by gene transfection in patients with severe HF. The RFA‐HF study did not provide convincing evidence for the use of radiofrequency ablation for atrial fibrillation but was underpowered. A wearable, multi‐sensor patch showed potential for detecting impending HF decompensation in MUSIC. A comparison of low‐intensity oral diuretic therapy in patients hospitalized with ADHF suggested that torasemide was superior to furosemide in DUEL. The use of point‐of‐care B‐type natriuretic peptide and echocardiography failed to improve the rate of correct HF diagnosis in primary care. Phrenic nerve stimulation improved symptoms of sleep apnoea in a small study of patients with HF and central sleep apnoea. The use of a novel implantable pulmonary artery pressure monitoring system to guide patient management improved outcomes in the CHAMPION study. A study to evaluate a combined coronary artery bypass grafting (CABG) and epicardial cardiac resynchronization therapy implantation procedure reduced mortality compared with CABG alone.