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

David Duncker 1, * Peter Paul Delnoy 2 Herbert Nägele 3 Jacques Mansourati 4, 5 Lluís Mont 6 Frédéric Anselme 7 Petra Stengel 8 Francesca Anselmi 9 Hanno Oswald 1 Christophe Leclercq 10
* Auteur correspondant
1 Departments of Cardiology and Angiology
2 Isala Klinieken
3 Albertinen Hospital - HAMBURG - Albertinen Hospital
4 CHRU - Cardio - Département de Cardiologie
5 ORPHY (EA 4324) - Optimisation des régulations physiologiques
6 Cardiology Department
7 Service de cardiologie [Rouen]
8 Sorin Group [München]
9 Sorin Group [Clamart]
10 Cardio - RENNES - Département de Cardiologie
Abstract : 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.
Keywords : Atrioventricular delay optimization SonRtip atrial lead Cardiac resynchronization therapy Peak endocardial acceleration Interventricular delay optimization
Type de document :
Article dans une revue
EP-Europace, Oxford University Press (OUP): Policy B, 2016, 18 (5), pp.755 - 761. 〈10.1093/europace/euv114〉
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http://hal.univ-brest.fr/hal-01259844
Contributeur : Ghislaine Calvez <>
Soumis le : jeudi 21 janvier 2016 - 10:27:12
Dernière modification le : jeudi 13 septembre 2018 - 15:17:14

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UNIV-BREST | LTSI | COMUE-NORMANDIE | UNIROUEN | ORPHY

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David Duncker, Peter Paul Delnoy, Herbert Nägele, Jacques Mansourati, Lluís Mont, et al.. First clinical evaluation of an atrial haemodynamic sensor lead for automatic optimization of cardiac resynchronization therapy.. EP-Europace, Oxford University Press (OUP): Policy B, 2016, 18 (5), pp.755 - 761. 〈10.1093/europace/euv114〉. 〈hal-01259844〉

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