May 6 2016
LivaNova, PLC, a market-leading medical technology and innovation company, today announced results from the RESPOND-CRT clinical trial, showing that a 35% risk reduction in heart failure hospitalization was associated with SonR.
The RESPOND-CRT trial was designed to investigate the clinical efficacy and safety of device-based optimization using the SonR cardiac contractility sensor in patients with advanced heart failure. The results, announced today by Prof. Josep Brugada at an oral late breaking presentation during the annual Heart Rhythm Society Meeting, showed that the study successfully met its primary and secondary end points.
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.
“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.”
“SonR is a great example of LivaNova’s commitment to developing innovative medical technology that really matters, and we would like to thank the participating centers and the several independent committees for their great support in this landmark study,” said Stefano Di Lullo, LivaNova, President of the CRM Business Unit. “The RESPOND-CRT trial results offer our CRM business a unique growth opportunity while helping physicians treat patients with heart failure globally.”1
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.
The design of the trial has been published in the American Heart Journal, 2014.2
About SonR contractility sensor
The SonR sensor uses measurements of cardiac contractility in order to optimize cardiac resynchronization therapy. The SonR cardiac contractility sensor consists of a micro accelerometer embedded in the tip of the SonRtip atrial lead. The sensor continuously measures the vibrations generated by the myocardium during cardiac contractions which are correlated to cardiac contractility. 3,4,5
The SonRtip lead is connected to a LivaNova CRT-D device featuring an algorithm which automatically adapts the atrioventricular (AV) and interventricular (VV) intervals based on cardiac contractility measurements. Optimization is performed on a weekly basis both at rest and during exercise. This allows for cardiac resynchronization therapy to be continuously adapted to the individual needs of each patient.
SonR technology is available exclusively in LivaNova CRT-D devices including the Paradym, Intensia and Platinium families. The new Platinium CRT-D SonR device was launched in Europe in November 2015.
References
- Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, et al. Heart disease and stroke statistics—2013 update: a report from the American Heart Association. Circulation. 2013;127:e6–e245
- Brugada J, Brachmann J, Delnoy PP, et al. Automatic optimization of cardiac resynchronization therapy using SonR-rationale and design of the clinical trial of the SonRtip lead and automatic AV-VV optimization algorithm in the paradym RF SonR CRT-D (RESPOND-CRT) trial. Am Heart J 2014;167:429-36.
- Rickards AF, Bombardini T, Corbucci G et al. An implantable intracardiac accelerometer for monitoring myocardial contractility. The multicenter PEA Study group. Pacing Clin Electrophysiol 1996;19:2066-2071
- Bongiorni MG, Soldati E, Arena G et al. Local myocardial contractility related to endocardial acceleration signals detected by a transvenous pacing lead. Pacing Clin Electrophysiol 1996;19:1682-1688
- Bordachar P, Garrigue S, Ritter P et al. Contributions of a hemodynamic sensor embedded in an atrial lead in a porcine model. J Cardiovasc Elrctrophysiol. 2011;22(5):579-83