BIOTRONIK Demonstrates Ongoing Commitment to Advancing Scientific Knowledge at HRS Four studies shown at Heart Rhythm 2023 were generated from BIOTRONIK’s CERTITUDE research program

Continuing a history of commitment to furthering research in its field, four studies supported by BIOTRONIK’s real-world evidence generating research initiative, CERTITUDE, were presented at Heart Rhythm 2023 on May 20^th and 21^st.

The CERTITUDE registry, established in 2020, is a comprehensive source of real-world data gathered from BIOTRONIK Home Monitoring^®, device tracking, and insurance claims data from qualifying US BIOTRONIK patients. This data is made available for physicians to leverage through submission and approval of a research proposal.

CERTITUDE’s robust database provides opportunities for research that require large continuous datasets, as demonstrated in an analysis by Dr. Krishna Pundi of Stanford Medicine (Stanford, CA) titled “Leveraging a Natural Experiment to Determine the Effect of Air Pollution on Ventricular Arrhythmias and Physical Activity: the 2020 U.S. Wildfires.” Data available from CERTITUDE allowed investigators to evaluate relationships between air pollution associated with wildfires and ventricular arrhythmias and markers of heart failure in patients with implantable cardiac devices.¹ Additionally, Dr. Abhishek Deshmukh of Mayo Clinic (Rochester, MN) presented CERTITUDE results looking at the impact of COVID-19 vaccinations on arrhythmias.² These real-world research projects are possible with access to a large retrospective database such as CERTITUDE.

Results from two other CERTITUDE analyses highlighted BIOTRONIK products, features and their corresponding benefits for patients and clinicians. An investigation led by Dr. Luigi Di Biase of Albert Einstein College of Medicine (New York, NY) into lead complication rates between BIOTRONIK single lead and dual lead ICD systems concluded that single lead systems, particularly BIOTRONIK’s DX technology, have a lower rate of lead-related complications over three years and results in reduced costs associated with hospitalizations due to these complications.³

Another study focused on BIOTRONIK’s early antitachycardia pacing (eATP) feature. It found eATP to be more successful at terminating ventricular tachycardia in the VF zone than traditional ATP and reduces unnecessary shocks.⁴ The eATP feature is an algorithm available in ICDs and CRT-Ds from the latest generation and, as with DX technology, is exclusive to BIOTRONIK.

“We are incredibly pleased with the variety of research that has already been performed using the CERTITUDE database,” says David Hayes, M.D., Chief Medical Officer, BIOTRONIK, Inc. “Our commitment to furthering scientific knowledge in our field is demonstrated not only through the studies we directly sponsor, but also through projects like CERTITUDE that allow us to support the scientific community as a whole.”

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References:

1. Pundi, K. et al. Leveraging a natural experiment to determine the effect of air pollution on ventricular arrhythmias and physical activity: The 2020 U.S. wildfires. Heart Rhythm 20, S666 (2023). 
2. Deshmukh, A. J. et al. COVID-19 vaccination impact on atrial arrhythmias – real-world evidence from the certitude registry. Heart Rhythm 20, S81 (2023).
3. Di Biase, L. et al. Real-world longitudinal data evaluation of complication rates and Medicare hospitalization costs between one-lead, hybrid, and two-lead ICD Systems. Heart Rhythm 20, S716–S717 (2023).
4. Daswani, M. et al. Shock reduction through early delivery of antitachycardia pacing for fast ventricular tachycardias. Heart Rhythm 20, S719 (2023).