Heart failure is a debilitating and progressive disease, tied to substantial patient morbidity and death, and to significant healthcare costs. Cardiac resynchronization therapy (CRT) is a proven treatment for patients who have heart failure due to reduced ejection fraction (a measure of the heart’s pumping ability) with ventricular dyssynchrony, where the lower chambers of the heart are not synchronized. CRT improves the heart’s pumping efficiency and reduces patient symptoms. Despite the proven safety and effectiveness of CRT, it remains underused due to the perception that up to one-third of patients do not benefit from (i.e., respond to) the therapy.

Medtronic sponsored the AdaptResponse study, the results of which were presented April 17, 2023, by study chair Bruce Wilkoff, M.D., of the Cleveland Clinic, as Late Breaking Science at the European Heart Rhythm Association Scientific Sessions 2023 in Barcelona. The study aimed to demonstrate improvement in patient outcomes (reduced mortality and heart failure events) and CRT response by comparing the Medtronic-exclusive AdaptivCRT™ algorithm, which measures and adjusts therapy according to each patient’s heart rhythm, with standard cardiac resynchronization therapy.

According to Alan Cheng, M.D., chief medical officer, Medtronic Cardiac Rhythm Management: “The study results show that AdaptivCRT provides similar outcomes to standard CRT, but did not meet the primary endpoint. AdaptResponse is a contemporary evaluation, where all patients in the study received some form of CRT, either AdaptivCRT or standard. Importantly, the study revealed that, with CRT, these heart failure patients experienced the:

• lowest mortality (16.5% at five years) of any randomized CRT trial, and
• highest response rate (93% at six months) of all clinical trials evaluating cardiac resynchronization therapy using the clinical composite score.

While the study did not show superiority of AdaptivCRT over standard CRT, these findings are encouraging news for patients with heart failure, showing that their prognosis with cardiac resynchronization therapy is substantially better than previously understood.”

AdaptResponse is the largest, global randomized controlled trial of cardiac resynchronization therapy, involving 3,617 patients with systolic heart failure and left bundle branch block from 227 centers in 27 countries. Additionally, 43% of the study participants were women, the largest proportion of women in a randomized controlled trial of cardiac resynchronization therapy.

Medtronic remains committed to developing clinical evidence critical to scientific advancement and medical practice that also has a significant, positive impact on patients’ lives.

CONTACT:
Tracy McNulty
Public Relations
+1-763-526-2492

Ryan Weispfenning
Investor Relations
+1-763-505-4626