title: Mesh ablator vs. cryoballoon pulmonary vein ablation of symptomatic paroxysmal atrial fibrillation: results of the MACPAF study.
abstract: OBJECTIVE
  Catheter ablation of the pulmonary veins (PVs) is a promising therapeutic approach for symptomatic atrial fibrillation (AF). The prospective randomized single-centre study 'Mesh Ablator versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation' (MACPAF; clinicaltrials.gov NCT01061931) compared the efficacy and safety of two balloon-based PV ablation systems.
  
  
  RESULTS
  Thirty-two patients underwent PV ablation for symptomatic paroxysmal AF using the Arctic Front® or the HD Mesh Ablator® catheter according to study protocol. The primary endpoint was complete PV isolation (PVI) at the end of the ablation procedure, determined by exit block after achieving entrance block. Long-term follow-up data are not included in this publication. Patients' mean age was 61.7 ± 8.9 years, 43.2% were female, and median CHA₂DS₂-VASc score was 2.0. In the intention-to-treat analysis, the rate of the primary endpoint was 56.5% in patients randomized to the Arctic Front® and 9.5% in patients randomized to the HD Mesh Ablator® catheter (P = 0.001). In the per-protocol analysis, complete PVI was achieved in 13 (76.5%) of 17 Arctic Front® patients but in none of the 15 HD Mesh Ablator® patients (P < 0.0001). There were one major and two minor complications in each study arm but no clinically evident stroke. Post-procedural AF recurrence was detected within hospital stay in two (11.8%) Arctic Front® patients and in seven (46.7%) HD Mesh Ablator® patients (P = 0.049).
  
  
  CONCLUSIONS
  The MACPAF study revealed a superiority of the Arctic Front® catheter concerning complete PVI. Owing to the insufficient efficacy of the HD Mesh Ablator® catheter, the safety board decided to stop MACPAF prematurely.
authors.affiliation: Department of Cardiology and Pneumology, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, D-12203 Berlin, Germany. lydia.koch@charite.de
authors.forename: Lydia
authors.initials: L
authors.lastname: Koch
authors.forename: Karl Georg
authors.initials: KG
authors.lastname: Haeusler
authors.forename: Juliane
authors.initials: J
authors.lastname: Herm
authors.forename: Erdal
authors.initials: E
authors.lastname: Safak
authors.forename: Robert
authors.initials: R
authors.lastname: Fischer
authors.forename: U
authors.initials: U
authors.lastname: Malzahn
authors.forename: Thomas
authors.initials: T
authors.lastname: Werncke
authors.forename: Peter U
authors.initials: PU
authors.lastname: Heuschmann
authors.forename: Matthias
authors.initials: M
authors.lastname: Endres
authors.forename: Jochen B
authors.initials: JB
authors.lastname: Fiebach
authors.forename: Heinz-Peter
authors.initials: HP
authors.lastname: Schultheiss
authors.forename: Alexander
authors.initials: A
authors.lastname: Schirdewan
mesh_terms: D000368:Aged; D001281:Atrial Fibrillation / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods*; D003452:Cryosurgery / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D011667:Pulmonary Veins / Q000601:surgery*; D012008:Recurrence; D013526:Surgical Mesh; D016896:Treatment Outcome