title: First clinical evaluation of an atrial haemodynamic sensor lead for automatic optimization of cardiac resynchronization therapy.
abstract: OBJECTIVE
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany duncker.david@mh-hannover.de.
authors.forename: David
authors.initials: D
authors.lastname: Duncker
authors.affiliation: Isala Klinieken, Dr Van Heesweg 2, 8025 AB Zwolle, The Netherlands.
authors.forename: Peter Paul
authors.initials: PP
authors.lastname: Delnoy
authors.affiliation: Albertinen Hospital, Süntelstr. 11a, 22457 Hamburg, Germany.
authors.forename: Herbert
authors.initials: H
authors.lastname: Nägele
authors.affiliation: Cardiology Department, Brest University Hospital, Boulevard Tanguy Prigent, 29609 Brest, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Mansourati
authors.affiliation: Cardiology Department - Arrhythmia Section, Thorax Institute - Hospital Clinic, University of Barcelona, Villarroel, 170, 08036, Barcelona, Spain.
authors.forename: Lluís
authors.initials: L
authors.lastname: Mont
authors.affiliation: Cardiology Department, Charles Nicolle University Hospital, 1 rue Germont, 76031 Rouen, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Anselme
authors.affiliation: Sorin Group Germany GmbH, Lindberghstr. 25, 80939 Munich, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Stengel
authors.affiliation: Sorin CRM SAS, 4 Avenue Réaumur, 92140 Clamart, France.
authors.forename: Francesca
authors.initials: F
authors.lastname: Anselmi
authors.affiliation: Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.
authors.forename: Hanno
authors.initials: H
authors.lastname: Oswald
authors.affiliation: Cardiology Department Pontchaillou, University Hospital, 2 rue Henri Le Guilloux, 35033 Rennes, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Leclercq
mesh_terms: D000368:Aged; D001145:Arrhythmias, Cardiac / Q000628:therapy*; D058406:Cardiac Resynchronization Therapy / Q000009:adverse effects / Q000592:standards*; D017147:Defibrillators, Implantable; D004562:Electrocardiography; D005060:Europe; D005260:Female; D006325:Heart Atria / Q000503:physiopathology; D006333:Heart Failure / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D006439:Hemodynamics; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
keywords: Atrioventricular delay optimization; Cardiac resynchronization therapy; Interventricular delay optimization; Peak endocardial acceleration; SonRtip atrial lead