Patients with systolic heart failure who received a novel technology using the SonR hemodynamic sensor were more likely to respond to cardiac resynchronization therapy (CRT) compared with those who used echocardiographic optimization, according to a prospective trial.
Patients in the SonR group also had a statistically significant, 35 percent reduction in heart failure-related hospitalizations.
Lead researcher Josep Brugada Terradellas, MD, PhD, of Hospital Clínic de Barcelona in Spain, presented the results on May 5 during a late-breaking clinical trial session at the Heart Rhythm Society’s scientific sessions in San Francisco.
The RESPOND-CRT study enrolled 1,039 patients from 125 sites in 12 countries in three continents, including North America. Of the patients, 998 were randomized in a 2:1 ratio after implantation to SonR-driven repetitive, automatic programming or echo-guided optimization.
The SonRtip lead (LivaNova) is an atrial pacing lead that has an embedded micro-accelerometer and measures the vibrations that correlate to S1 heart sounds. The SonR technology is used in CRT devices for heart failure that automatically determines the optimal atrioventricular (AV) and interventricular (VV) delays during rest and exercise.
The SonR technology is not yet FDA-approved and is not available in the U.S.
At baseline, the groups were well balanced. The mean age was approximately 67 years old, and nearly 70 percent of patients were males.
The researchers said that the primary efficacy endpoint (the rate of clinical responders) and co-primary safety endpoints (greater than 91% freedom from acute and greater than 94 percent freedom from chronic complications related to the SonRtip lead) were met.
After 12 months, the response rates were 75.0 percent for patients using the SonRtip lead and 70.4 percent for patients with echocardiographic optimization. The difference was not statistically significant.
Subgroup analyses of sick patients with a history of atrial fibrillation or renal failure found that patients had better outcomes with the SonR hemodynamic sensor.
“With one-third of patients not responding properly to current CRT optimization methods, we saw the need to explore alternative methods to improve patient outcomes,” Brugada Terradellas said in a news release. “This new SonR technology is the first system to automatically optimize for patients every week. Importantly, it works while the patient is active and therefore provides patients with a better way of life. This is a very promising technology for patients managing their heart failure and has the potential to become the new gold standard for CRT optimization.”