Focus on Pulmonary Vein Isolation
Pulmonary Vein Re-Isolation as a Routine Strategy Regardless of Symptoms: The PRESSURE Randomized Controlled Trial

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Abstract

Objectives

The goal of this study was to determine whether a strategy of early re-isolation of pulmonary vein (PV) reconnection in all patients, regardless of symptoms, would reduce the recurrence of atrial fibrillation (AF) and improve quality of life.

Background

Lasting pulmonary vein isolation (PVI) remains elusive. PV reconnection is strongly linked to the recurrence of arrhythmia.

Methods

A total of 80 patients with paroxysmal AF were randomized 1:1 after contact force-guided PVI to receive either standard care or undergo a repeat electrophysiology study after 2 months regardless of symptoms (repeat study). At the initial procedure, PVI was demonstrated by entrance/exit block and adenosine administration after a minimum 20-min wait. At the repeat study, all sites of PV reconnection were re-ablated. Patients recorded electrocardiograms daily and whenever symptomatic for 12 months using a handheld monitor. Recurrence was defined as ≥30 s of atrial tachyarrhythmia (AT) after a 3-month blanking period. The Atrial Fibrillation Effect on Quality-of-Life Questionnaire was completed at baseline and at 6 and 12 months.

Results

All 40 patients randomized to repeat study attended for this after 62 ± 6 days, of whom 25 (62.5%) had reconnection of 41 (26%) PVs. There were no complications related to these procedures. Subjects recorded a total of 32,203 electrocardiograms (380 [335 to 447] per patient) during 12.6 (12.2 to 13.2) months of follow-up. AT recurrence was significantly lower for the repeat study group (17.5% vs. 42.5%; p = 0.03), as was AT burden (p = 0.03). Scores on the Atrial Fibrillation Effect on Quality-of-Life Questionnaire were higher in the repeat study group at 6 months (p < 0.001) and 12 months (p = 0.02).

Conclusions

A strategy of routine repeat assessment with re-isolation of PV reconnection improved freedom from AT recurrence, AT burden, and quality of life compared with current standard care. (The Effect of Early Repeat Atrial Fibrillation [AF] on AF Recurrence [PRESSURE]; NCT01942408)

Key Words

atrial fibrillation
catheter ablation
pulmonary vein isolation
pulmonary vein reconnection

Abbreviations and Acronyms

AF
atrial fibrillation
AFEQT
Atrial Fibrillation Effect on Quality-of-Life Questionnaire
AT
atrial tachyarrhythmia
ECG
electrocardiogram
PV
pulmonary vein
PVI
pulmonary vein isolation
SC
standard care

Cited by (0)

The PRESSURE study was supported by an investigator-initiated study grant from Biosense Webster, Inc. (IIS-239). The funders approved the study design but had no involvement in the collection, analysis, or interpretation of data; the writing of the manuscript; or the decision to submit for publication. Dr. Todd has received speaker fees from Boston Scientific and Medtronic. Dr. Hall has received speaker fees from Medtronic; speaker fees and fellowship support from Boston Scientific; and educational event support from Biosense Webster, Inc. Dr. Gupta has received speaker fees, research grants, and fellowship support from Biosense Webster, Inc.; and is on the St. Jude Medical Proctor's Panel for implantation of the Amulet device. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.