Real‐world evidence in a national health service: results of the UK CardioMEMS HF System Post‐Market Study

Abstract

Aims The CardioMEMS HF System Post‐Market Study (COAST) was designed to evaluate the safety, effectiveness, and feasibility of haemodynamic‐guided heart failure (HF) management using a small sensor implanted in the pulmonary artery of New York Heart Association (NYHA) Class III HF patients in the UK, Europe, and Australia. Methods and results COAST is a prospective, international, multicentre, open‐label clinical study (NCT02954341). The primary clinical endpoint compares annualized HF hospitalization rates after 1 year of haemodynamic‐guided management vs. the year prior to sensor implantation in patients with NYHA Class III symptoms and a previous HF hospitalization. The primary safety endpoints assess freedom from device/system‐related complications and pressure sensor failure after 2 years. Results from the first 100 patients implanted at 14 out of the 15 participating centres in the UK are reported here. At baseline, all patients were in NYHA Class III, 70% were male, mean age was 69 ± 12 years, and 39% had an aetiology of ischaemic cardiomyopathy. The annualized HF hospitalization rate after 12 months was 82% lower [95% confidence interval 72–88%] than the previous 12 months (0.27 vs. 1.52 events/patient‐year, respectively, P < 0.0001). Freedom from device/system‐related complications and pressure sensor failure at 2 years was 100% and 99%, respectively. Conclusions Remote haemodynamic‐guided HF management, using frequent assessment of pulmonary artery pressures, was successfully implemented at 14 specialist centres in the UK. Haemodynamic‐guided HF management was safe and significantly reduced hospitalization in a group of high‐risk patients. These results support implementation of this innovative remote management strategy to improve outcome for patients with symptomatic HF. Clinical registration number: http://ClinicalTrials.gov identifier: NCT02954341.

Ambulatory haemodynamic‐guided management reduces heart failure hospitalizations in a multicentre European heart failure cohort

“…Our results are in line with previous studies that have reported an absolute decrease of 1-5 mmHg after 12 months. 3,6,9,14,15 PAP-guided therapy resulted in a reduction in total HF hospitalizations of 50% after 6 months and 40% after 12 months. In the CHAMPION trial remote PAP monitoring reduced HF hospitalizations by 33% after a mean follow-up of 18 months in NYHA class III patients with a previous HF hospitalization 16 and these results were reproduced in several post-approval observational studies.…”

“…In the CHAMPION trial remote PAP monitoring reduced HF hospitalizations by 33% after a mean follow-up of 18 months in NYHA class III patients with a previous HF hospitalization 16 and these results were reproduced in several post-approval observational studies. [4][5][6]9,14 In contrast, the very recent GUIDE-HF (Haemodynamic-Guided Management of Heart Failure) trial in NYHA class II-IV patients with a previous HF hospitalization or elevated N-terminal pro-BNP failed to show a benefit of remote PAP monitoring on all-cause mortality and total HF events. 17 However, a prespecified COVID-19 sensitivity analysis suggested a significant impact of COVID-19 on the results.…”

History and evolution of pacing and devices

“…These data are transmitted for trend review by the clinical team and allow for early adjustment of diuretic therapy prior to the onset of clinical decompensation. Combined UK experience from multiple centres has been recently published and the system has been approved for routine clinical use in the NHS in 2021 50…”

Pulmonary Artery Pressure-Guided Telemonitoring Reduced Pulmonary Artery Pressure but Did Not Result in Higher Doses of Guideline-Directed Medical Therapy–Observations from an Advanced Elderly German Heart Failure Cohort

“…Standard HF medications, such as beta blockers, angiotensin-converting enzyme inhibitors (ACE-I), angiotensin receptor blockers (ARB), aldosterone antagonists, angiotensin receptor-neprilysin inhibitors (ARNI), and sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors) all improved survival [ 9 , 10 , 11 , 12 , 13 , 14 , 15 ] rates, prevented recurrent hospitalizations due to worsening HF, and improved the clinical status, functional capacity, and quality of life [ 6 ]. However, the target dose of evidence-based medication is generally difficult to reach outside of clinical trials [ 16 ], and elderly patients are even less likely to receive evidence-based HF therapy [ 17 ]. Previous analyses have shown that prevalent comorbidities and associated multi-drug treatments are the most prominent factors limiting uptitration in elderly people [ 18 ].…”