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Observational Study
. 2023 Aug 2;25(9):euad221.
doi: 10.1093/europace/euad221.

Acute and mid-term outcomes of ablation for atrial fibrillation with VISITAG SURPOINT: the Japan MIYABI registry

Affiliations
Observational Study

Acute and mid-term outcomes of ablation for atrial fibrillation with VISITAG SURPOINT: the Japan MIYABI registry

Ken Okumura et al. Europace. .

Erratum in

Abstract

Aims: The effectiveness of pulmonary vein isolation (PVI) guided by VISITAG SURPOINT (VS) has been demonstrated in Western populations. However, data for Asian populations are limited. VS settings may differ for Asians, given their smaller body size. This study aimed to describe outcomes of radiofrequency atrial fibrillation (AF) ablation guided by VS in a large Asian population.

Methods and results: The prospective, observational, multicentre MIYABI registry collected real-world data from patients undergoing VS-guided AF ablation using ThermoCool SmartTouch and ThermoCool SmartTouch SF catheters from 50 Japanese centres. All patients had paroxysmal AF or persistent AF for <6 months. Primary adverse events (PAEs) were evaluated for safety. The primary efficacy endpoint was the proportion of patients with PVI at the end of the procedure. Mid-term effectiveness (up to 12 months) was evaluated by freedom from documented atrial arrhythmias. Of the 1011 patients enrolled, 1002 completed AF ablation. The mean number of VS values per procedure was 428.8 on the anterior wall and 400.4 on the posterior wall. Nine patients (0.9%) experienced PAEs. Upon procedure completion, 99.7% of patients had PVI. Twelve-month freedom from atrial arrhythmia recurrence was 88.5%; 5.7% of patients were re-ablated. At repeat ablation, 54% of RSPV, 73% of RIPV, 70% of LSPV, and 86% of LIPV evaluated remained durably isolated.

Conclusion: Despite lower anterior wall VS values compared with the CLOSE protocol (≥550), the present study demonstrated comparable efficacy outcomes, indicating that a VS of ≥550 for the anterior wall may not be necessary for Asian patients.

Keywords: Ablation index; Asian; Atrial fibrillation; Pulmonary vein isolation; VISITAG SURPOINT.

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Conflict of interest statement

Conflict of interest: K.O. received lecture fees from Johnson & Johnson K.K. as part of the submitted work and received lecture fees from Daiichi Sankyo Co., Ltd; Nippon Boehringer Ingelheim Co., Ltd; Bristol-Myers Squibb K.K.; and Medtronic Japan Co., Ltd outside of the submitted work. K.I. received remuneration for lecture, consultant, and proctor from Johnson & Johnson K.K. as part of the submitted work and received remuneration for lecture, consultant, and proctor from Medtronic Japan Co., Ltd; Boston Scientific Japan K.K.; Japan Lifeline Co., Ltd; Daiichi Sankyo Co., Ltd; Bayer Yakuhin, Ltd; Bristol-Myers Squibb K.K.; Nippon Boehringer Ingelheim Co., Ltd; and Abbott outside of the submitted work. M.G. received lecture fees from Johnson & Johnson K.K. as part of the submitted work and received lecture fees from Medtronic Japan Co., Ltd; Bayer Yakuhin, Ltd; Abbott, Phillips Japan, Ltd; Cook Medical Japan G.K.; and Japan Lifeline Co., Ltd, and received research funds from Japan Lifeline Co., Ltd, outside of the submitted work. H.O. received remuneration from Johnson & Johnson K.K. as part of the submitted work and received a writing fee from MSD K.K., a lecture fee from Canon Medial Systems Corp., and a consultant fee from Kaken Pharmaceutical Co., Ltd, outside of the submitted work. M.Y. is an employee of Johnson & Johnson K.K., as indicated in the submitted work. A.N. received honoraria from Biosense Webster, Inc., as part of the submitted work and received honoraria from Abbott and Biosense Webster, Inc., and an endowment from Medtronic Japan Co., Ltd, and DVx Inc. outside of the submitted work.

Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
Patient disposition. PVI, pulmonary vein isolation; VS, VISITAG SURPOINT. aPopulation who met the eligibility criteria and had a catheter inserted. bThose in the total population who underwent PVI with VS -guided ablation.
Figure 2
Figure 2
Details of the ablation procedure (A) and cumulative distribution of VS values in the anterior, posterior, and oesophagus regions (B). Ant, anterior; ESO, oesophagus; LIPV, left inferior pulmonary vein; LSPV, left superior pulmonary vein; post, posterior; RIPV, right inferior pulmonary vein; RSPV, right superior pulmonary vein; VS, VISITAG SURPOINT. an = 965, bn = 651, cn = 954, dn = 955, en = 952, and fn = 960.
Figure 3
Figure 3
First-pass isolation rate (A), recurrence-free rates at 12 months (B), and re-ablation-free rates at 12 months (C) in MIYABI, US SURPOINT COA and Europe VISTAX studies. Definition of first-pass isolation rate for each study: MIYABI, PVI after a first encirclement that remained isolated until the end of the procedure; US SURPOINT COA, PVI toward the end of the procedure confirmed by an entrance block; Europe VISTAX, first-pass isolation proof to a 30-min wait period and adenosine challenge. Rates were determined by standard-of-care monitoring. AF, atrial fibrillation; PVI, pulmonary vein isolation.

Comment in

References

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