Elsevier

Heart Rhythm

Volume 10, Issue 9, September 2013, Pages 1318-1324
Heart Rhythm

Phrenic nerve paralysis during cryoballoon ablation for atrial fibrillation: A comparison between the first- and second-generation balloon

https://doi.org/10.1016/j.hrthm.2013.07.005Get rights and content

Background

Phrenic nerve palsy (PNP) is the most frequently observed complication during cryoballoon ablation (CB; Arctic Front, Medtronic, MN) occurring in roughly 7%–9% of the cases. The new second-generation cryoballoon ablation Arctic Front Advance (CB-A) (Arctic Front) has recently been launched in the market.

Objective

To evaluate the incidence of right PNP with the new CB-A in comparison with the first-generation balloon in a series of consecutive patients that underwent pulmonary vein isolation with this modality.

Methods

The study was designed as an observational study with a prospective follow-up. In total, 121 consecutive patients were included: 80 patients with the CB (group 1) and 41 with the CB-A (group 2).

Results

Mean procedural times, fluoroscopic times, and time to pulmonary vein isolation documented by real-time recordings were significantly lower in group 2 (P ≤ .05). The occurrence of PNP was significantly higher in group 2 (6.25% [5 of 80] in group 1 vs 19.5% [8 of 41] in group 2; P = .033). At 7 months, PNP persisted in 1 (2.5%) patient in the CB-A group.

Conclusions

Right PNP seems to occur in a significantly larger number of patients with the second-generation CB-A. However, this complication is reversible in nearly all cases on short-term follow-up. More refined phrenic nerve monitoring during right-sided pulmonary vein ablation and less vigorous wedging maneuvers in the pulmonary vein ostia might significantly reduce the occurrence of this complication.

Introduction

Phrenic nerve palsy (PNP) is the most frequently observed complication during cryoballoon ablation (CB) (Arctic Front, Medtronic, MN) for drug-resistant atrial fibrillation (AF).1, 2 Recent articles state that this complication occurs in approximately 7%–9% of the procedures,1, 3 although, virtually always reversible, cases of permanent PNP have been reported. Recent developments have led to the launch of the second-generation CB Arctic Front Advance (CB-A) (Medtronic) in the market. Owing to significant technological improvements, this new tool permits a more homogeneous circumferential lesion around the pulmonary vein (PV) ostium if compared to the previous generation CB.4 We hope that this will lead to higher rates of permanent PVI and therefore better clinical outcome. However, little is known about the rate of PNP during ablation with the CB-A. The aim of the present study was to compare the incidence, the clinical features, and the outcome of PNP between patients having undergone pulmonary vein isolation (PVI) with the first-generation CB or the second-generation CB-A.

Section snippets

Patient population

The study was designed as a retrospective study of patients discharged from the Heart Rhythm Management Center, Free University of Brussels, Belgium. A total of 121 consecutive patients admitted to our hospital for CB were included in the study (the last 80 and first 41 patients having undergone PVI with the first-generation CB and the second-generation CB-A, respectively). Data were obtained from charts after discharge and included basic demographic and preablation clinical information, date

Baseline population characteristics

In total, 121 consecutive patients were included. Groups 1 and 2 consisted in 80 and 41 patients, respectively. Table 1 gives the patient demographics and clinical characteristics of the study population.

Procedural characteristics

All patients underwent a procedure with the large 28 mm CB. A total of 483 of 484 (99.7%) PVs could be isolated with balloon only. Focal touch-up was needed in 1 (0.8%) patient. The mean total procedure time was 119 ± 21 minutes in group 1 vs 93 ± 19 minutes in group 2 (P < .001). The mean

Discussion

The main findings of our study are as follows: (1) right PNP occurs significantly more frequently during ablation with the second-generation 28 mm CB-A if compared to its predecessor; (2) it might also occur in the RIPV in a significant number of cases; (3) no anatomical predictors of PNP could be observed; and (4) in nearly all cases it is a reversible complication.

The CB-A has been launched in the market with technical modifications designed to improve procedural outcome significantly. This

Conclusions

Right PNP seems to occur in a significantly larger number of patients with the second-generation CB-A. However, this complication is reversible in nearly all cases on short-term follow-up. More refined PN monitoring during right-sided PV ablation and less vigorous wedging maneuvers in the PV ostia might significantly reduce the occurrence of this complication.

References (14)

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    However, a specific risk profile should be considered when performing AFCB ablation. Most importantly, as the cooling characteristics of the second-generation AFCB were improved, an increase in (right sided) phrenic nerve damage resulting in hemidiaphragmatic paralysis was observed with an incidence of approximately 3% in recent trials (41,45,66,67). The risk increases if greater pressure is applied on the balloon during freezing, but it may be reduced significantly if the approach is modified to ablate at a more ostial location and by using the larger 28-mm balloon (34,67).

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Dr Chierchia, Dr Sarkozy, and Dr de Asmundis have received compensation for teaching purposes from AF Solutions and Medtronic. Dr Chierchia has received compensation for proctoring purposes from AF Solutions and Medtronic. Dr Brugada has received speaker fees from Medtronic.

The first 2 authors contributed equally to this work.

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