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: ClinicalTrials.gov identifier: NCT02954341.

Keywords: CardioMEMS™ HF System; Clinical trial results; Haemodynamic monitoring; Heart failure; Pulmonary artery pressure; UK.

Conflict of interest statement

M.R.C. reports grants and personal and study conduction fees from Abbott. A.F. reports research grants and speaker honoraria from Abbott. P.C. reports speaker honoraria from Abbott. P.F. reports study conduction fees from Biotronik, British Heart Foundation, Bristol Myers Squibb, Novo Nordisk, Johnson & Johnson, Sanofi, Amgen, and Bayer; personal fees from Novartis and Pharmacosmos; and grants and personal fees from Medtronic. B.C. reports personal fees from Abbot, Medtronic, Biotronik, Novartis, and AstraZeneca and non‐financial support from Merit Medical. I.L. and T.R.B. report personal fees from Abbott. C.C. reports consulting fees from Abbott; speaker honoraria from AstraZeneca, Novartis, and Bayer; and travel/meeting attendance support from Novartis. R.S.G. reports grants, personal fees, and non‐financial support from Abbott; grants, personal fees, and other from Boston Scientific (BSCI); and personal fees from Novartis, AstraZeneca, Vifor, Boehringer Ingelheim, Servier, and Pharmacosmos. K.G. reports honoraria from Novartis and AstraZeneca. G.C.‐W., A.Z., C.H., and D.R. have nothing to disclose. H.S.L. reports honoraria from Abbott. A.P. reports grants from Medtronic and personal fees from Medtronic and Abbot. S.P. reports support for educational activities from Abbott. C.G. and J.H. are Abbott employees. P.B.A. is an Abbott employee and stockholder.

© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

Figures

Figure 1

CONSORT diagram.

Figure 2

Heart failure hospitalization (HFH) reduction.

Figure 3

(A) Area under the curve. (B) Weekly home pulmonary artery pressure (PAP) reading compliance.