CardioMEMS European Monitoring Study for Heart Failure

Heart failure (HF) is a clinical syndrome characterized by frequent
hospitalization, poor quality of life, multiple comorbidities, high mortality
and a complex therapeutic regimen. Affected individuals suffer from impairment
of functional capacity and have a variety of symptoms such as dyspnea, fatigue,
limited exercise tolerance, fluid retention, pulmonary congestion and
peripheral edema.
HF is a progressive disease associated with high patient morbidity and
mortality and a poor quality of life. Prognosis following a diagnosis of heart
failure is poor and 5-year survival rates compare badly with those of most
cancers. Heart failure is incurable and while patients may die from other
causes not directly linked to heart failure once diagnosed with heart failure,
they will not be cured of the syndrome by any currently available therapy.

Estimates of the prevalence and incidence of heart failure vary due to
differences in definition and assessment of heart failure, there is no
gold-standard assessment to diagnose the presence of the disease. The
prevalence of heart failure is generally accepted to be 1-2% of the population
in the western world with the incidence approaching 5 * 10 people per 1000 per
year. The total population of 28 EU member states by January 2013 was estimated
to be 505,674,9655 giving an estimated number of heart failure patients of
between five and ten million (1 * 2%) in the EU.
This highly prevalent disease leads to over 1,000,000 hospitalizations each
year for decompensation requiring acute medical care. Over 90% of patients
hospitalized for heart failure are congested with excess body volume resulting
in increased pulmonary artery pressures. Current disease management tools are
insensitive in estimating pulmonary artery pressures and are of limited utility
in remotely monitoring the patient. New technology development has led to a
fully implantable leadless and battery-less sensor that can provide pulmonary
artery pressures by remote interrogation from the patient*s home.

The CardioMEMS* HF System consists of a wireless, battery-less pressure sensor
implanted into the pulmonary artery and external electronics that power and
communicate with the sensor and that transmit pulmonary artery pressure
waveforms and measurements to a secure website for physician/health care
professional review and patient management.

The CHAMPION trial demonstrated that management of heart failure using
pulmonary artery pressure information obtained with the CardioMEMS HF System,
in addition to traditional signs and symptoms, reduced HF hospitalizations.

The CHAMPION trial was conducted at 64 U.S. centers and enrolled 550 patients
with NYHA Class III heart failure who had been hospitalized for heart failure
in the previous year. All patients were implanted with a sensor and then
randomized to Treatment (heart failure management on the basis of pulmonary
artery pressure and standard of care) or Control (heart failure management on
the basis of standard of care). CHAMPION met its primary endpoint of reduction
in the rate of heart failure hospitalizations at 6 months with Treatment
patients having 28% fewer heart failure hospitalizations compared to Control
patients; benefit was sustained with a 37% reduction in heart failure
hospitalizations over the full randomized study duration13. All secondary
endpoints were met demonstrating reduction in pulmonary artery pressures,
reduction in proportion of patients hospitalized for heart failure, increase in
days alive outside the hospital and improved quality of life.

Studies to date have demonstrated a reduction in HF-related hospitalizations
and improved quality of life in patients using the CardioMEMS HF System when
compared with patients receiving standard of care in the United States. The
purpose of this study is to characterize the use of the CardioMEMS HF System
when used in a real-world setting.

This study is a prospective, non-randomized, open-label, multi-center,
post-market study.

Implantation of CardioMEMS sensor

Studies to date have demonstrated a reduction in HF-related hospitalizations
and improved quality of life in patients using the CardioMEMS HF System. Risks
associated with the implantation and use of the device are minor, generally
without serious consequences, and occur at a low rate. The CHAMPION Clinical
Trial7 reported no pressure sensor failures, and device/system Related
Complications occurred in only 1% of the cases with an additional 1% of the
patients experiencing a Procedure-related adverse event. Therefore, there is
reasonable evidence that the clinical benefits for this procedure outweigh the
risks and thus provide justification for proceeding with this observational
study.