Method of an Epidemiological Risk Study in Tens of Thousands Patients With Wearable Cardioverter Defibrillator for Prevention of Sudden Cardiac Death in Heart Failure Patients With Reduced Left Ventricular Ejection Fraction
Author(s)
Brigitte Both, PhD1, Kathrin Staudacher, PhD2, Frank Semrau, PhD2.
1Director Health Policy & Economics, Zoll CMS GmbH, Köln, Germany, 2Health Policy & Economics, Zoll CMS GmbH, Köln, Germany.
1Director Health Policy & Economics, Zoll CMS GmbH, Köln, Germany, 2Health Policy & Economics, Zoll CMS GmbH, Köln, Germany.
OBJECTIVES: Sudden cardiac arrest (SCA) followed by sudden cardiac death (SCD) is a major cause of mortality worldwide. This research aims to measure the incidence of life-threatening arrythmias in a SCA/SCD high risk group. The SCA/SCD incidence will be measured with appropriate Wearable Cardioverter Defibrillator (WCD) treatment(s). WCDs are technologies available in Japan, US and Europe. This research aims to explore if WCD recordings can serve to evaluate the risk in an underdiagnosed patients’ group regarding their risk of SCA/SCD during the acute phase of drug therapy optimization phase.
METHODS: The study protocol is an observational non-interventional, non-invasive, multicentre epidemiological risk study to evaluate SCA/SCD-risk expressed as cumulative incidence density in patients SCA/SCD risk, for a respective country. The WCD is assigned by the prescribing physician, patients wear the device, the ECG recording starts and time zero is defined. The WCD is prescribed as part of the usual daily clinical practice with guideline directed medication therapy (GDMT). Since SCA/SCD risk patients presumably have a true WCD appropriate treatment-rate of at least 1.2%, for the detection of 1.0% with a probability of 0.05 (95% CI, 0.008; 0.0123), a sample of 8928 per HF aetiology is necessary.
RESULTS: Patient history is extracted from documents collected for the country specific health care system to justify the prescription of the WCD for the insurer. WCD ECG stored data will be integrated into the database to assess treatments. Careful assignment to diagnoses and outcomes will be performed by the research team and controlled by independent researchers.
CONCLUSIONS: The full dataset of this RWD study from each individual country should give insights of the epidemiological risk of SCA/SCD under modern GDMT. The comprehensive database along with ECG recordings can be used for further research purposes including artificial intelligence assisted tools to explore causes and disease burden of SCA/SCD.
METHODS: The study protocol is an observational non-interventional, non-invasive, multicentre epidemiological risk study to evaluate SCA/SCD-risk expressed as cumulative incidence density in patients SCA/SCD risk, for a respective country. The WCD is assigned by the prescribing physician, patients wear the device, the ECG recording starts and time zero is defined. The WCD is prescribed as part of the usual daily clinical practice with guideline directed medication therapy (GDMT). Since SCA/SCD risk patients presumably have a true WCD appropriate treatment-rate of at least 1.2%, for the detection of 1.0% with a probability of 0.05 (95% CI, 0.008; 0.0123), a sample of 8928 per HF aetiology is necessary.
RESULTS: Patient history is extracted from documents collected for the country specific health care system to justify the prescription of the WCD for the insurer. WCD ECG stored data will be integrated into the database to assess treatments. Careful assignment to diagnoses and outcomes will be performed by the research team and controlled by independent researchers.
CONCLUSIONS: The full dataset of this RWD study from each individual country should give insights of the epidemiological risk of SCA/SCD under modern GDMT. The comprehensive database along with ECG recordings can be used for further research purposes including artificial intelligence assisted tools to explore causes and disease burden of SCA/SCD.
Conference/Value in Health Info
2025-09, ISPOR Real-World Evidence Summit 2025, Tokyo, Japan
Value in Health Regional, Volume 49S (September 2025)
Code
RWD63
Topic Subcategory
Health & Insurance Records Systems
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory)