First clinical evaluation of an atrial haemodynamic sensor lead for automatic optimization of cardiac resynchronization therapy

• Published in: Europace (London, England) Vol. 18; no. 5; pp. 755 - 761
• Main Authors: Duncker, David, Delnoy, Peter Paul, Nägele, Herbert, Mansourati, Jacques, Mont, Lluís, Anselme, Frédéric, Stengel, Petra, Anselmi, Francesca, Oswald, Hanno, Leclercq, Christophe
• Format: Journal Article
• Language: English
• Published: England Oxford University Press (OUP) 01-05-2016; Oxford University Press
• Subjects: Aged; Arrhythmias, Cardiac - therapy; Cardiac Resynchronization Therapy - adverse effects; Cardiac Resynchronization Therapy - standards; Cardiology and cardiovascular system; Clinical Research; Defibrillators, Implantable; Electrocardiography; Europe; Female; Heart Atria - physiopathology; Heart Failure - etiology; Heart Failure - mortality; Heart Failure - therapy; Hemodynamics; Human health and pathology; Humans; Life Sciences; Longitudinal Studies; Male; Middle Aged; Prospective Studies; Treatment Outcome; Interventricular delay optimization; Peak endocardial acceleration; SonRtip atrial lead; Cardiac resynchronization therapy; Atrioventricular delay optimization
• ISSN: 1099-5129; 1532-2092
• DOI: 10.1093/europace/euv114

One option to improve cardiac resynchronization therapy (CRT) responder rates lies in the optimization of pacing intervals. A haemodynamic sensor embedded in the SonRtip atrial lead measures cardiac contractility and provides a systematic automatic atrioventricular and interventricular delays optimization. This multi-centre study evaluated the safety and performance of the lead, up to 1 year.
A total of 99 patients were implanted with the system composed of the lead and a CRT-Defibrillator device. Patients were followed at 1, 3, 6, and 12 months post-implant. The primary safety objective was to demonstrate that the atrial lead complication free rate was superior to 90% at 3-months follow-up visit. A lead handling questionnaire was filled by implanting investigators. Lead electrical performances and the performance of the system to compute AV and VV delays were evaluated at each study visit over 1 year. The complication free rate at 3 months post-implant was 99.0% [95%CI 94.5-100.0%], P < 0.001. Electrical performances of the lead were adequate whatever the atrial lead position and remained stable over the study period. The optimization algorithm was able to compute AV and VV delays in 97% of patients, during >75% of the weeks.
The atrial lead is safe to implant and shows stable electrical performance over time. It therefore offers a promising tool for automatic CRT optimization to further improve responder rates to CRT.