title: One-year clinical outcome after ablation with a novel multipolar irrigated ablation catheter for treatment of atrial fibrillation: potential implications for clinical use.
abstract: OBJECTIVE
  Pulmonary vein isolation (PVI) is an established therapy for atrial fibrillation (AF). However, PVI remains a time-consuming procedure. A novel multipolar irrigated radiofrequency (RF) ablation catheter (nMARQ™) is aiming to improve PVI. We investigated the influence on procedural parameters and assessed clinical outcomes after PVI using this novel catheter.
  
  
  RESULTS
  Fifty-eight consecutive patients with paroxysmal AF were equally allocated (n = 29/group) to PVI treatment with (i) the novel multipolar ablation catheter (nMARQ™) and (ii) a standard single-tip ablation catheter (SAC). Study endpoints included procedure time, fluoroscopy time, radiation dose, RF time, number of energy applications, and clinical outcome defined as freedom from AF after a single procedure. Successful PVI was confirmed by a separate circular, multipolar mapping catheter in all patients treated with the nMARQ™. Pulmonary vein isolation was achieved in 100% in the SAC group. In the nMARQ™ group, PVI was suggested in all patients. However, confirmatory mapping revealed persistent pulmonary vein (PV) conduction in 19 out of 29 nMARQ™ patients. These patients underwent further ablation, which still failed to achieve PVI in 5 of the 29 nMARQ™ patients, mainly due to significant temperature rise in the oesophagus and device-related limitations reaching the right inferior PV. Mean fluoroscopy time (31 ± 12 vs. 23 ± 10 min, P < 0.05) and (132 ± 37 vs. 109 ± 30 min, P < 0.05) were longer in nMARQ™ vs. SAC patients. Radiofrequency time was shorter in nMARQ™ vs. SAC group (21 ± 9 vs. 35 ± 12 min, P < 0.001). Radiation dose and the number of energy applications did not differ between both groups. Clinical outcome analysis revealed no significant differences (nMARQ™: 72 vs. SAC: 72%) after a mean follow-up of 373 ± 278 days.
  
  
  CONCLUSIONS
  The use of the nMARQ™ catheter is associated with important device-related limitations to achieve successful PVI. However, clinical outcomes were equivalent in nMARQ™- and SAC-treated patients.
authors.affiliation: Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany German Cardiovascular Research Center (DZHK), partner site: Munich Heart Alliance, Munich, Germany reza.wakili@med.uni-muenchen.de.
authors.forename: Reza
authors.initials: R
authors.lastname: Wakili
authors.affiliation: Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Siebermair
authors.affiliation: Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Fichtner
authors.affiliation: Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
authors.forename: Moritz F
authors.initials: MF
authors.lastname: Sinner
authors.affiliation: Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Klocker
authors.affiliation: Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
authors.forename: Lucia
authors.initials: L
authors.lastname: Olesch
authors.affiliation: Department of Anesthesiology and Critical Care Medicine, Eberhard Karls University, Tübingen, Germany.
authors.forename: Jan N
authors.initials: JN
authors.lastname: Hilberath
authors.affiliation: Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
authors.forename: Samira
authors.initials: S
authors.lastname: Sarai
authors.affiliation: Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany Cardiovascular Research Center, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Clauss
authors.affiliation: Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Sattler
authors.affiliation: Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany German Cardiovascular Research Center (DZHK), partner site: Munich Heart Alliance, Munich, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Kääb
authors.affiliation: Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
authors.forename: Heidi L
authors.initials: HL
authors.lastname: Estner
mesh_terms: D000241:Adenosine / Q000097:blood; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000628:therapy*; D017115:Catheter Ablation / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D005471:Fluoroscopy; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D011446:Prospective Studies; D011667:Pulmonary Veins / Q000601:surgery; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000241:Adenosine
keywords: Ablation; Arrhythmia; Atrial fibrillation; Pulmonary vein isolation; nMARQ catheter