Novel cryoballoon technology for atrial fibrillation ablation: Impact of pulmonary vein variant anatomy, cooling characteristics, and 1-year outcome from the CHARISMA registry

Schiavone, M; Bianchi, S; Malacrida, M; Fassini, G; Ricciolino, R; Pecora, D; Pelargonio, G; Iacopino, S; Ducceschi, V; Maggio, R; Bianchini, L; La Greca, C; Rossi, P; Bencardino, G; Moltrasio, M; Di Belardino, N; Pepi, P; Rossi, L; Santagostino, M; Tondo, C; De Simone, A

doi:10.1016/j.hrthm.2024.08.040

Arrhythmias & electrophysiology

Novel cryoballoon technology for atrial fibrillation ablation: Impact of pulmonary vein variant anatomy, cooling characteristics, and 1-year outcome from the CHARISMA registry

Heart RhythmPublished 22 Aug 2024Prospective registry study

Main finding · ATA recurrenceResultHazard ratio 1.43 95% CI 0.49–4.13

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Authors' conclusion

The POLARx CB system demonstrated long-term efficacy, along with a safe profile, in both patients with paroxysmal AF and those with peAF, regardless of the presence PV variants. Time to isolation was longer in patients with ATA recurrences during follow-up.

Study context

Population: Patients with paroxysmal atrial fibrillation (AF) (83.4%) or persistent AF (16.6%) undergoing POLARx cryoballoon ablation
Participants: 429 consecutive patients

Exposure: Pulmonary vein (PV) anatomy variants vs standard PV anatomy after POLARx cryoballoon ablation
PV variantsn = 28
Standard PV anatomyn = 401reference
Outcome: Absence of any atrial tachyarrhythmias (AF/atrial flutter/atrial tachycardia)
Follow-up: 1 year

Methodological detailsmulticentre, consecutive patients

Multicentre
Consecutive patients

Main finding

ATA recurrence · mean 431 ± 99 days of follow-up, after blanking period

Hazard ratio

1.43

95% CI 0.49–4.13

P = 0.4384

Events by group

PV variants17.9%5 of 28

Standard PV anatomy14.5%58 of 401

PV variantsvs Standard PV anatomy

HR 1.43 (95% CI 0.49–4.13); P = 0.4384

As reported in the abstract

Overall ATA recurrence: 63 patients (14.7%)

Observational data: associations, not effects.

Secondary outcomes

Thaw time, recurrence vs no recurrence

P = 0.0012

Recurrencemean 18.5 secondsSD 7

No recurrencemean 19.8 secondsSD 7

Time to isolation, recurrence vs no recurrence

P = 0.04

Recurrencemean 57.4 secondsSD 42

No recurrencemean 49.1 secondsSD 33

Predictors of ATA recurrence (adjusted)

	← Lower risk ←→ Higher risk →	HR (95% CI)	P value
HFAdjusted for confounders	0.10.31310	4.12 (1.75–9.73)	P = 0.0013
peAFAdjusted for confounders	0.10.31310	1.81 (1.03–3.18)	P = 0.0433
	0.10.31310Hazard ratio (log scale)

Thaw time, recurrence vs no recurrence

Shorter total deflation time with recurrence

Cooling characteristics, standard PVs vs PV variants

Nadir temperature, thaw time and total deflation time differed between standard PVs and PV variants

Original publication

Novel cryoballoon technology for atrial fibrillation ablation: Impact of pulmonary vein variant anatomy, cooling characteristics, and 1-year outcome from the CHARISMA registry. Heart Rhythm. Published 22 August 2024. doi:10.1016/j.hrthm.2024.08.040

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