Association of Ambulatory Hemodynamic Monitoring of Heart Failure With Clinical Outcomes in a Concurrent Matched Cohort Analysis

Abstract

IMPORTANCE In a randomized clinical trial, heart failure (HF) hospitalizations were lower in patients managed with guidance from an implantable pulmonary artery pressure sensor compared with usual care. It remains unclear if ambulatory monitoring could also improve long-term clinical outcomes in real-world practice. OBJECTIVE To determine the association between ambulatory hemodynamic monitoring and rates of HF hospitalization at 12 months in clinical practice. DESIGN, SETTING, AND PARTICIPANTS This matched cohort study of Medicare beneficiaries used claims data collected between June 1, 2014, and March 31, 2016. Medicare patients who received implants of a pulmonary artery pressure sensor were identified from the 100% Medicare claims database. Each patient who received an implant was matched to a control patient by demographic features, history of HF hospitalization, and number of all-cause hospitalizations. Propensity scoring based on comorbidities (arrhythmia, hypertension, diabetes, pulmonary disease, and renal disease) was used for additional matching. Data analysis was completed from July 2017 through January 2019. EXPOSURES Implantable pulmonary artery pressure monitoring system. MAIN OUTCOMES AND MEASURES The rates of HF hospitalization were compared using the Andersen-Gill method. Days lost owing to events were compared using a nonparametric bootstrap method. RESULTS The study cohort consisted of 1087 patients who received an implantable pulmonary artery pressure sensors and 1087 matched control patients. The treatment and control cohorts were well matched by age (mean [SD], 72.7 [10.2] years vs 72.9 [10.1] years) and sex (381 of 1087 female patients [35.1%] in each group), medical history, comorbidities, and timing of preimplant HF hospitalization. At 12 months postimplant, 616 HF hospitalizations occurred in the treatment cohort compared with 784 HF hospitalizations in the control cohort. The rate of HF hospitalization was lower in the treatment cohort at 12 months postimplant (hazard ratio [HR], 0.76 [95% CI, 0.65-0.89]; P < .001). The percentage of days lost to HF hospitalizations or death were lower in the treatment group (HR, 0.73 [95% CI, 0.64-0.84]; P < .001) and the percentage of days lost owing to all-cause hospitalization or death were also lower (HR, 0.77 [95% CI, 0.68-0.88]; P < .001). CONCLUSIONS AND RELEVANCE Patients with HF who were implanted with a pulmonary artery pressure sensor had lower rates of HF hospitalization than matched controls and spent more time alive out of hospital. Ambulatory hemodynamic monitoring may improve outcomes in patients with chronic HF.

Invasive Devices and Sensors for Remote Care of Heart Failure Patients

“…Additional analyses in a subset of 480 patients showed a risk reduction of 34% (HR 0.66, 95% CI 0.57–0.76) after 12 months of follow-up [ 26 ]. Another cohort study used the Medicare claims database to identify 1087 CardioMEMS patients and matched these patients to 1087 control patients by using the propensity score technique [ 27 ]. A significant difference in HF hospitalization rates was found in favor of the CardioMEMS cohort at 12 months post-implant (HR 0.76, 95% CI 0.65–0.89).…”

Clinical Update of the Latest Evidence for CardioMEMS Pulmonary Artery Pressure Monitoring in Patients with Chronic Heart Failure: A Promising System for Remote Heart Failure Care

“…CardioMEMS is the only invasive heart failure (HF) remote monitoring sensor with Food and Drug Administration (FDA) approval and European Conformity (CE) mark. The CardioMEMS HF system is recommended in the European Society of Cardiology (ESC) guidelines of 2016 with a class II b level B recommendation, which is expected to be upgraded in the newest version of the guidelines in 2021 with evidence from several new studies [1,[6][7][8][9][10]. The CardioMEMS PA sensor has no internal power supply and is fully compatible with implantable cardioverter defibrillators (ICDs), (cardiac resynchronization therapy) CRT devices and left ventricular assist devices (LVADs).…”

“…Several studies have examined the effectiveness of ambulatory hemodynamic monitoring by the CardioMEMS HF system in reducing HF hospitalization outside strict clinical trials or prospective study settings [ 9 , 10 ]. Desai et al conducted a retrospective cohort study using 1114 patients from the U.S. Medicare claims database who had a CardioMEMS sensor implanted between 1 June 2014 and 31 December 2015 [ 9 ].…”

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

“…23 Subsequent real-world data in thousands of patients demonstrate similar outcomes to those reported in the CHAMPION pivotal trial. [24][25][26] Most recently, large propensity matched analyses in real-world cohorts found that haemodynamically monitored patients with HF had significant reductions in days lost due to death or hospitalization, with associative improved survival in the monitored group. 26 Haemodynamic guided HF management with remote PA pressure monitoring, however, was predominantly tested in the United States healthcare system.…”

“…[24][25][26] Most recently, large propensity matched analyses in real-world cohorts found that haemodynamically monitored patients with HF had significant reductions in days lost due to death or hospitalization, with associative improved survival in the monitored group. 26 Haemodynamic guided HF management with remote PA pressure monitoring, however, was predominantly tested in the United States healthcare system. The PA pressure monitoring system (CardioMEMS TM HF System, Abbott, Atlanta, GA, USA) has the CE mark and Therapeutic Goods Administration approval and is modelled to possibly be cost-effective in other geographies.…”