Ablation as first line treatment of paroxysmal atrial fibrillation

Atrial fibrillation (AF) is leading to electrical and structural remodeling. In
patients with paroxysmal AF there is minimal remodeling. In case of advanced
remodeling restoration of sinus rhythm becomes more difficult and the results
of catheter ablation of arrhythmogenic foci are disappointing. Catheter
ablation in the very early stages of the disease could therefore be more
effective than antiarrhythmic drug (AAD) therapy: it holds the potential to
treat AF and reverse remodeling leading to better rhythm control.

Primary objectives: To find out whether catheter ablation in the very early
stages of AF ( i.e. no structural nor electrical remodeling) compared to AADs
leads to 1) more effective rhythm control after a blanking period of three
months during an initial follow-up of six months, 2) less frequent progression
of disease after at least two years follow-up. Secondary objectives are 1)
describing the electrophysiologic behaviour of AF with continuous monitoring in
the absence of important electrical or structural remodeling, 2) effectivity of
catheter ablation for paroxysmal AF regarding AFburden and progression to
persistent or permanent AF during a follow-up of three years, 3) the comparison
of the quality of life (as assessed using Quality of Life (QoL) and symptom
questionnaires), 4) number of acute or chronic complications and
hospitalization rate during a three year follow-up, 5) definition of a
well-described cohort of early-ablated paroxysmal AF patients for long term
follow-up.

Single center, randomized, controlled trial

Patients in the intervention group will undergo isolation of all pulmonary
veins (PV) and nonPV foci. Patients in the control group will be treated with
AADs except for amiodarone. Patients in both the intervention and control group
will be continuously monitored with an implantable cardiac monitor (REVEAL*,
Medtronic) during the whole follow-up period of the study (i.e. three years).

Patients assigned to the intervention group will undergo cryothermal pulmonary
vein isolation. Cryothermal catheter ablation is a safe procedure with a risk
of peri-operative complications of 6%, which is mostly due to a transient
phrenic nerve palsy.30 However, it should be noted that many of the
complications, although serious, typically result in only acute and not
longterm morbidity. These complications include femoral pseudoaneurysm,
arteriovenous fistula, pneumothorax, hemothorax, transient ischemic attack, and
cardiac tamponade. The most serious complications resulting in permanent
disability were uncommon (death in 0.05% and stroke in 0.28%). In our
electrophysiology department we performed more than 200 AF ablation procedures
over the last four years with an overall major complication rate comparable to
other experienced centres.31 Implantation of the REVEAL device, is common
clinical practice. The REVEAL device is placed under the skin in the upper
chest area. The recommended implant zones are from the left parasternal area
extending to the mid-clavicular line between the first intercostal space and
the fourth rib. During the brief procedure, the area is numbed with local
anesthesia, a small incision is made, and the monitor is inserted. The mean
complication of this procedure, is pocket infection with an occurrence rate of
less than 1%.