SAN FRANCISCO – Repeat, invasive electrophysiology studies conducted 2 months after pulmonary vein isolation – regardless of symptoms and, if necessary, with repeat ablations – substantially reduce atrial fibrillation recurrence and improve quality of life at 1 year, according to an investigation conducted at the Liverpool (Eng.) Heart and Chest Hospital.

After initial pulmonary vein isolation (PVI), 40 patients with drug-refractory, paroxysmal atrial fibrillation (AF) were randomized to the repeat approach, and 40 others to the current standard of care (SC), meaning repeat PVI based on recurrent AF symptoms.

Pulmonary vein reconnections were found in 25 patients (63%) checked at 2 months, and all 25 had repeat PVIs without complications. Meanwhile, nine (23%) patients in the SC group had repeat PVIs for clinical recurrence at a mean of about 7 months.

At one year, 33 patients in the repeat group (82.5%), but only 23 in the SC group (57.5%), were free of atrial tachyarrhythmia (AT) (P = .03), and total group AT burden was lower (91 versus 127 days, P = .03). Quality of life scores on the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire were higher in the repeat study group, too (mean 92.2 versus 79.1 out of 126 points, P = .030).

“A strategy of early assessment with re-isolation of PV reconnections can be deployed safely and improves freedom from AT recurrence and quality of life compared with current standard care. While the gold standard remains durable PVI from the initial procedure, until rates of this can be substantially improved, early re-intervention could be considered as a reasonable strategy to improve outcomes,” the investigators concluded.

“If it was my dad and I was doing a PVI today, I’d say, ‘Dad, let’s bring you back and look at how you’re doing in 2 months,’” lead investigator Dr. Dhiraj Gupta said during an interview after his presentation at the Heart Rhythm Society annual meeting.

“We can’t really afford to do everybody twice, but this has certainly lowered our threshold for reintervention,” said Dr. Gupta, a cardiologist at the Liverpool hospital. “We used to try antiarrhythmic drugs” for recurrence; “we don’t do that anymore. We complete the job that [we] set out to do in the first place. Our threshold is any recurrence beyond 1 month. A surprising number of patients agree with this [recheck] strategy, which is one of the reasons we didn’t have a single drop out in this study. I tell them that it’s highly likely that some of the pulmonary veins I isolated for them are going to reconnect.”

Audience members were concerned that 15 patients in the study arm (38%) ended up having an invasive test they didn’t need. Dr. Gupta said it’s a “glass half full or half empty” situation. “I see it as half full. These repeat procedures are short, safe, and quick [about 80 minutes], and even shorter for those patients who don’t require pulmonary reisolation.” For those patients who do, only a few have symptoms; the rest would have had to wait for remergent symptoms to trigger a second procedure. “I believe that these repeat procedures have become so safe that the risk is more than made up” for by the benefits.

There were no complications with early reinterventions, and there were just two complications with the original PVI; one patient who ended up in the repeat group had a spontaneously resolving phrenic nerve palsy with the first procedure, and one SC patient had a transient ischemic attack. In short, “the complication rates for the two groups were identical,” Dr. Gupta said.

Patients were split about evenly between men and women in both study arms, and patients were in their early 60s, on average. The mean baseline AFEQT score was 46.8 points; 78% in the standard care group, but 55% in the early reintervention group, were on baseline anticoagulants.

All of the subjects were given portable ECG recorders after their initial PVIs, and told to take a daily 30-second recording, and to record if they felt any heart symptoms. They followed the instructions and made more than 32,000 recordings.

Every PVI patient at the Liverpool hospital now gets a recorder at discharge, and physicians there base early interventions on the results, whether or not patients are symptomatic. “We’ve bought lots of them, and tell patients to have a low threshold for recording. I believe 24-hours Holters are a bit outdated,” Dr. Gupta said.

All the PVIs in the study were contact-force guided and used wide area circumferential ablation with the help of 3-D mapping and automated lesion tagging. Entrance and exit block were demonstrated, and adenosine was administered to unmask dormant reconnections after a waiting period of at least 20 minutes. Antiarrhythmic drugs were stopped at 4 weeks.

Biosense Webster funded the work. Dr. Gupta is a speaker for and receives research and fellowship funding from the company.

aotto@frontlinemedcom.com

PVI redo at 2 months drops 1 year AF recurrence by 30%