December 9, 2021ESC Heart Failure49 citationsOpen Access
Real-World Evidence in a National Health Service: Results of the UK CardioMEMS HF System Post-Market Study
Key Result
Haemodynamic-guided heart failure management using the CardioMEMS HF System significantly reduced the annualized heart failure hospitalization rate by 82% (IRR 0.18) compared to the year prior to implantation.
Study Design
Type
Observational (n=100)
Blinding
Open-label
Multicenter
Yes
Structured PICO
Does haemodynamic-guided heart failure management using a pulmonary artery sensor reduce heart failure hospitalization rates in patients with NYHA Class III symptoms and a previous hospitalization?
P
Population
100 adults (mean age 69) with NYHA Class III heart failure and a recent hospitalization, managed with a pulmonary artery sensor and followed for 1 year.
I
Intervention
Haemodynamic-guided heart failure management using a permanently implanted pulmonary artery pressure sensor (CardioMEMS HF System) with daily home pressure uploads and medication adjustments for 12 months.
C
Comparator
Historical control (the 12-month period prior to sensor implantation in the same patients).
O
Outcome
Annualized heart failure hospitalization rates after 1 year of haemodynamic-guided management vs. the year prior to sensor implantation. Primary safety endpoints: freedom from device/system-related complications and pressure sensor failure after 2 years.hard clinical
Haemodynamic-guided heart failure management using an implanted pulmonary artery sensor significantly reduced heart failure hospitalizations by 82% compared to the prior year in a real-world UK cohort.
Main Result
Relative Risk: 0.18 (95% CI 0.12–0.28)
Absolute Event Rate: 0.27% vs 1.52%
p-value: p=<0.0001
Limitations
- Lack of a contemporary control group as a comparator (historical control analysis)
- Potential placebo effect of remote monitoring was uncontrolled
- Possibility that patients did not have structured HF management in the 12 months prior to sensor implantation
- Lack of a contemporary control group (historical control analysis)
- Potential placebo effect of remote monitoring uncontrolled
- Possible confounding factors not controlled
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.