Proposal: Redo Ablation for Paroxysmal AF, Symptoms or Not

May 08, 2016

SAN FRANCISCO, CA — Catheter ablation of symptomatic paroxysmal atrial fibrillation (PAF), as effective as it is with contemporary equipment and techniques, isn't always durable. Actually, the ablated circuitry around the pulmonary veins often, perhaps even most of the time, reestablish themselves so that AF recurs.

Symptomatic recurrences are often addressed with a repeat cath ablation, but based on their randomized trial, researchers say a better strategy is to redo the pulmonary-vein isolation (PVI) procedure in all patients 2 months after their initial ablation[1]. That's whether or not they have developed recurrent symptoms or even silent AF.

With that approach after an initial ablation for symptomatic PAF, compared with repeat PVI driven by symptoms or documented recurrent AF, the group saw significant declines in AF recurrence and in total AF burden and significantly improved quality-of-life scores.

Dr Dhiraj Gupta

The Pulmonary Vein Re-Isolation as a Routine Strategy: A Success Rate Evaluation (PRESSURE) trial was limited by including only 80 patients at a single tertiary-care center with the latest equipment and operators highly experienced in AF ablation, acknowledged Dr Dhiraj Gupta (Liverpool Heart and Chest Hospital, UK), who presented the trial here at the Heart Rhythm Society (HRS) 2016 Scientific Sessions.

The trial's patients were essentially healthy except for their symptomatic PAF, and in those who later received repeat catheter ablations, the second ablations were short and not associated any complications, according to Gupta.

"Even though this is not a life-threatening arrhythmia, paroxysmal atrial fib can have a huge impact on quality of life," Gupta told heartwire from Medscape.

Freedom from Arrhythmia and Complication Rates, Routine Repeat Procedure vs Standard Care

Parameter Routine repeat procedure (n=40) Standard care (n=40) P
Total freedom from atrial tachyarrhythmia at 12 months (%) 82.5 57.5 0.03
Total atrial tachyarrhythmia burden (d) 91 127 0.03
Complications (% of patients) 2.5 2.5 >0.99
Complications (% of procedures) 1.25 2.0 >0.99

"In our hands, repeat AF ablation is a very straightforward undertaking," he said. "Clearly that's the direction to travel for the electrophysiology community—as AF ablation becomes more commonplace and procedure numbers increase, one would hope that our safety data are going to be replicated more widely."

About 62% of patients who went to a repeat procedure regardless of AF or symptom recurrence showed electrophysiologic signs of reestablished pulmonary-vein connections, Gupta reported. About 22% randomized to the standard approach ultimately went to a second procedure; almost 90% of those showed electrophysiologic recurrence.

"I Couldn't Do it in My Practice"

After Gupta's presentation of PRESSURE at the HRS sessions, a flurry of audience responses questioned the "ethics" and "cost conscientiousness" of the routine strategy and offered recurrence-driven repeat procedures as a better alternative—even for very experienced centers.

Dr John D Day (Intermountain Medical Center, Salt Lake City, UT), comoderator for the session, pointed out for heartwire that 38% of the trial's patients randomized to a redo procedure at 2 months had an unnecessary procedure, with all the attendant, well-recognized procedure-related risks. "I couldn't do it in my practice," he said about the routine strategy; if operators do it enough, they'll eventually see complications.

However, said Day, who isn't associated with PRESSURE, "they had a lot of people that could have benefited from a redo procedure. So I think the answer is somewhere in the middle," that is, redo procedures driven by AF. "I don't see any downside to waiting for a recurrence."

The trial randomized 80 patients with uncomplicated successful catheter ablation of symptomatic, drug-refractory PAF to undergo a repeat EP study after 2 months regardless of symptoms or documented AF or to standard care consisting of symptom- or AF-driven repeat procedures. The study excluded patients with persistent AF, a prior AF ablation procedure, or severe structural heart disease or left ventricular dysfunction.

The two groups were about equally divided between men and women and were similar at baseline with respect to age, mean left atrial diameter, LVEF, prevalence of oral anticoagulation, and quality-of-life scores according to the Atrial Fibrillation Effect on Quality-of-life (AFEQT) Questionnaire. Their initial procedures were similar with respect to mean duration (165 minutes), mean ablation time (44 minutes), and rate of pulmonary-vein isolation (99.4%).

All patients engaged a commercially available, portable cardiac rhythm monitor (Omron Heartscan HCG-801) once daily or on development of symptoms. All antiarrhythmic drugs were stopped 4 weeks after the first procedure, Gupta said.

Prevalence and Characteristics of Redo Procedure, Routine Repeat Procedure vs Standard Care

Parameter Routine repeat procedure (n=40) Standard care (n=40)
Redo PVI (%) 100 22.5
Time to redo (median d) 62 210
PV reconnection (% of patients) 62 88
Procedure time (min) 80 115
Ablation time (min) 5.1 12.3

Gupta said when interviewed that he "would love to" do a repeat procedure in every patient like those who entered the study, symptoms or not, if costs were not an issue. "We don't offer it to all our patients; we would get a call from the [UK National Health Service] if we started doing that. But we certainly have a very low threshold for offering the intervention. And if anyone has any [recurrent] atrial fibrillation following the first month, we will take them back to the lab."

Baseline and Follow-up Scores on the Atrial Fibrillation Effect on Quality-of-life Questionnaire

Time point Routine repeat procedure (n=40) Standard care (n=40) P
Baseline 46.3 47.7 0.895
6 mo 88.1 60.2 0.0005
12 mo 91.7 77.8 0.034

The study was funded by Biosense Webster, for which Gupta discloses being on the speaker's bureau and receiving research grants and fellowship support. Disclosures for the coauthors are listed in the abstract.

Follow Steve Stiles on Twitter: @SteveStiles2. For more from theheart.org, follow us on Twitter and Facebook.

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