SAN FRANCISCO — A new technology using a hemodynamic sensor is safe and effective to use to enhance response to cardiac resynchronization therapy in patients with HF, according to data presented at the Heart Rhythm Society Annual Scientific Sessions.
In the RESPOND-CRT noninferiority trial, 998 patients with CRT devices from 125 sites in 12 countries were randomly assigned to receive the new technology, which consists of a microaccelerometer embedded in the tip of an atrial pacing lead (SonRtip lead, Sorin Group/LivaNova), or an echocardiographic-guided optimization of atrioventricular and interventricular intervals, the standard technique to enhance response to CRT.
The primary efficacy endpoint was the rate of clinical responders. Primary safety endpoints were greater than 91% freedom from acute complications and greater than 94% freedom from chronic complications related to the tip lead. In addition, there was a secondary endpoint of death or HF hospitalization.
According to the results presented, the response rate for patients assigned the novel lead was 75% vs. 70% for patients with echocardiographic optimization (P < .001). In addition, patients in the novel lead group had 98% freedom from acute complications and 99% freedom from chronic complications.
“All-cause death and HF hospitalization were similar in both arms of the study, but in the SonR group there was a 35% reduction in hospitalizations related to HF,” Josep Brugada Terradellas, MD, PhD, from Hospital Clinic de Barcelona, Spain, said during a presentation. “The SonRtip lead presented a very good safety profile and all efficacy endpoints were met. The clinical response for most subgroups was in favor of the use of the SonRtip lead, especially in patients with a history of [atrial fibrillation].”
Superiority was not met, but the trial was not powered for it, Brugada Terradellas said during a press conference. – by Tracey Romero
Brugada Terradellas J, et al. LBCT 01. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 4-7, 2016; San Francisco.
Disclosure: The trial was sponsored by LivaNova. Brugada Terradellas reports no relevant financial disclosures.