Trial shows 35% Risk Reduction in Heart Failure Hospitalization using SonR
NICE, France, June 9, 2016
LivaNova, PLC, a market-leading medical technology and innovation company, today announced results from the RESPOND-CRT clinical trial at CARDIOSTIM-EHRA EUROPACE, Nice, France, showing that a 35% risk reduction in heart failure hospitalization was associated with SonR.
The trial was designed to investigate the clinical efficacy and safety of device-based optimization (compared to optimisation using echocardiography) using the SonR cardiac contractility sensor in patients with advanced heart failure.
The device combines the functions of an Implantable Cardiac Defibrillator (ICD) with Cardiac Resynchronization Therapy (CRT). The SonR sensor consists of a micro-accelerometer embedded in the tip of the SonRtip atrial lead. It measures the vibrations generated by the myocardium during cardiac contractions, which are correlated to cardiac contractility.
Prof. Josep Brugada told delegates at Cardiostim that the study successfully met its primary and secondary end points. “In order to deliver the very best CRT treatment to our heart failure patients, there has been a real need for an optimization solution that is both automatic and efficient,” said Prof. Josep Brugada, MD, PhD, Cardiovascular Institute, Hospital Clínic, University of Barcelona, Spain.
“Today the results of the RESPOND-CRT trial have shown that SonR perfectly meets this need. The high rates of responders together with the beneficial improvements in clinical outcomes indicate a significant advancement in CRT therapy, one that will allow us to better treat a larger number of heart failure patients.”
The proprietary SonR optimization system allows for cardiac resynchronization therapy to be continuously adapted to the needs of each patient, thus delivering individualized therapy.
In the RESPOND-CRT trial, optimization with SonR was compared to optimization using echocardiography. Even though echo-guided optimization was considered best practice in terms of reducing the number of non-responders to CRT, it has never been widely adopted in routine practice because of the significant resource consumption it requires.
The overall positive response to CRT reached in the group of patients treated with SonR was 75%, a reduction of approximately 16% in non- responders versus the echo group. In addition to a global favorable effect on long-term heart failure hospitalization, optimization with SonR resulted in a significant improvement in clinical response for patients with a history of atrial fibrillation or renal dysfunction.
ABOUT THE RESPOND-CRT TRIAL
The RESPOND-CRT study is a prospective, multicenter, randomized, double-blind study designed to evaluate the safety and efficacy of the SonR system. The trial enrolled 1,039 patients at 125 sites in Europe, US and Australia who were implanted with a CRT-D device. Patients were randomized 2:1 to receive either AV or VV optimization with SonR or echocardiography. The primary analyses were performed at 12 months.
The RESPOND-CRT trial is an Investigation Device Exemption (IDE) study approved by the Food and Drug Administration (FDA).
The study met all of its primary safety and efficacy end points.
The SonRtip lead was proven to be safe, with only 1% of patients reporting lead dislodgement and 0.1% of patients reporting lead fracture.
Optimization with SonR was proven to be as effective as echo-guided optimization based on responder rates. Patients were defined as responders at 12 months based on a hierarchical set of criteria as follows: alive, free from heart failure events, with an improved NYHA functional class or quality of life. Responder rates were 75% in the SonR arm and 70.4% in the Echo arm with the P value [P <0.0001] of the non-inferiority test showing that SonR is as effective as AV and VV echo-guided CRT optimization.