Phased RF ablation in persistent atrial fibrillation.
BACKGROUND
Persistent and long-standing persistent atrial fibrillation (AF) often requires extensive and/or repeat radiofrequency (RF) ablation procedures.


OBJECTIVE
The Tailored Treatment of Persistent Atrial Fibrillation (TTOP-AF) study assessed the effectiveness and safety of the phased RF system in a randomized controlled comparison of medical therapy against phased RF ablation for the management of persistent and long-standing persistent AF.


METHODS
Patients who had failed at least 1 antiarrhythmic drug (AAD) were randomized (2:1) to ablation management (AM) or medical management (MM). AM patients were allowed up to 2 ablations. Index and retreatment procedures consisted of pulmonary vein isolation and ablation of complex fractionated atrial electrograms. MM patients received AAD changes and/or cardioversion. The primary end points of the TTOP-AF study included chronic effectiveness and safety at 6 months and acute safety within 7 days of ablation.


RESULTS
At 6 months, a greater proportion of AM patients achieved effectiveness off AAD (77 of 138 [55.8%]) compared to MM patients (19 of 72 [26.4%]) (P < .0001). Acutely, 92.8% (128/138) of the procedures were successful while 12.3% (17/138) experienced a serious procedure and/or device-related adverse event. The predefined acute safety end point was not met. The proportion of patients with chronic safety events did not differ significantly between groups.


CONCLUSIONS
Catheter ablation of persistent/long-standing persistent AF with the phased RF ablation system is effective with greater reduction of AF compared with MM. More intense anticoagulation strategies, careful attention to catheter placement relative to the pulmonary vein ostia, and elimination of electrode interaction are expected to reduce the risk of stroke, pulmonary vein stenosis, and asymptomatic cerebral emboli.
The Ohio State University, Columbus, Ohio. Electronic address: John.Hummel@osumc.edu.
John
J
Hummel
Brigham and Women's Hospital, Boston, Massachusetts.
Gregory
G
Michaud
Iowa Heart Center, Des Moines, Iowa.
Robert
R
Hoyt
Emory Crawford Long Hospital, Atlanta, Georgia.
David
D
DeLurgio
Texas Heart Institute at St. Luke's Episcopal Hospital, Houston, Texas.
Abdi
A
Rasekh
St. Luke's Hospital, Mayo Clinic, Jacksonville, Florida.
Fred
F
Kusumoto
Genesis Medical Center, Davenport, Iowa.
Michael
M
Giudici
Piedmont Hospital, Atlanta, Georgia.
Dan
D
Dan
Austin Heart, Austin, Texas.
David
D
Tschopp
The John Hopkins Medical Institute, Baltimore, Maryland.
Hugh
H
Calkins
St. Antonius Ziekenhuis, Nieuwegein, The Netherlands.
Lucas
L
Boersma
D000293:Adolescent; D000328:Adult; D000368:Aged; D001281:Atrial Fibrillation / Q000188:drug therapy / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019233:Retreatment; D020521:Stroke / Q000209:etiology; D016896:Treatment Outcome
AAD; ACE; AF; AM; Ablation; Atrial fibrillation; CFAE; Complex Fractionated Atrial Electrogram; DCCV; FDA; Food and Drug Administration; INR; ITT; International normalized ratio; LA; LMWH; LVEF; MAAC; MASC; MM; OAT; PV; PVAC; Persistent; Phased RF; RF; SR; TEE; TTOP; TTOP-AF; Tailored Treatment of Persistent Atrial Fibrillation; ablation management; antiarrhythmic drug; asymptomatic cerebral embolus; atrial fibrillation; direct current cardioversion; intention to treat; left atrial; left ventricular ejection fraction; low-molecular weight heparin; medical management; multiarray ablation catheter; multiarray septal catheter; oral anticoagulation therapy; pulmonary vein; pulmonary vein ablation catheter; radiofrequency; sinus rhythm; transesophageal echocardiography