In Norway the prevalence of chronic heart failure has been estimated to be 2 per cent, meaning 80 000 – 100 000 people. Around 75 per cent of heart failure patients are older than 75 years old. Furthermore, patients diagnosed with heart failure account for approximately 5 per cent of all hospital admissions in Norway, and at any one time about 20 per cent of patients on a medicine department consist of heart failure patients.
The New York Heart Association (NYHA) has categorised heart failure into four classes. Class I and class II are considered mild. Class III is considered moderate and class IV is considered severe. The CardioMEMS™ HF System implantable pulmonary artery pressure sensor is to be used by patients classified within class III, i.e. moderate heart failure.
The CardioMEMS™ HF System is only commercially available in the USA.
In USA the CardioMEMS™ HF System was approved through the Premarket Approval (PMA) process by the U.S. Food and Drug Association (FDA) in May 2014. Approval was based upon one randomised, controlled clinical trial. The approved indication is: «This device is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalised for heart failure in the previous year. The haemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalisations».
This single technology assessment was commissioned by the National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway. They wanted Norwegian Institute of Public Health to evaluate the efficacy, safety and health economic documentation for continuous monitoring of pulmonary artery pressure via an implanted wireless and battery-free pressure sensor (CardioMEMS™ HF System) compared to standard treatment for the management of patients with New York Heart Association (NYHA) class III heart failure. We have evaluated the submitted documentation up towards available published documentation.