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Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms - 30/10/21

Doi : 10.1016/j.ahj.2021.08.007 
Nikola Pavlovic, MD a, r, 1, ⁎ , Gian-Battista Chierchia, MD b, 1, Vedran Velagic, MD c, Jean Sylvain Hermida, MD d, Stewart Healey, MD e, Giuseppe Arena, MD f, Nicolas Badenco, MD g, Christian Meyer, MD h, Jian Chen, MD i, Saverio Iacopino, MD j, Frédéric Anselme, MD k, Lukas Dekker, MD l, Fernando Scazzuso, MD m, Douglas L Packer, MD n, Carlo de Asmundis, MD b, Heinz-Friedrich Pitschner, MD o, Fabio Di Piazza, MSc p, Rachelle E Kaplon, PhD q, Malte Kuniss, MD o

Cryo-FIRST Investigators2

  A complete listing of investigators is available in the supplemental appendix.

a Sestre Milosrdnice University Hospital Centre, Zagreb, Croatia 
b Heart Rhythm Management Centre, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel, Brussels, Belgium 
c University Hospital Centre Zagreb, Zagreb, Croatia 
d Centre Hospitalier Universitaire d'Amiens-Picardie, France 
e Monash Health, Clayton, Australia 
f Ospedale Apuane, Massa Carrara, Italy 
g AP-HP Sorbonne Université, ICAN Institute, Hospital Pitié-Salpétrière, Paris, France 
h Cardiac Neuro- and Electrophysiology Research Consortium, EVK Düsseldorf, University Heart Center, Hamburg, Germany 
i Haukeland University Hospital, University of Bergen, Bergen, Norway 
j GVM Care&Research, Maria Cecilia Hospital, Cotignola, Italy 
k CHU de Rouen, Rouen, France 
l Catharina Ziekenhuis, Eindhoven, The Netherlands 
m Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina 
n Mayo Clinic Hospital - St. Mary's Campus, Rochester, Minnesota, USA 
o Kerckhoff Heart Center, Bad Nauheim, Germany 
p Medtronic, Core Clinical Solutions, Study and Scientific Solutions, Rome, Italy 
q Medtronic, Cardiac Ablation Solutions, Minneapolis, Minnesota 
r University Hospital Dubrava, Zagreb, Croatia 

⁎Reprint requests: Nikola Pavlovic, MD, University Hospital Dubrava, Av. Gojka Šuška 6, Zagreb, 10000 Croatia.University Hospital DubravaAv. Gojka Šuška 6Zagreb10000Croatia

Riassunto

Background

Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized.

Methods

Patients aged 18 to 75 with symptomatic paroxysmal AF naïve to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary.

Results

Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P <0.05). At 12 months, the mean adjusted difference in the AFEQT summary score was 9.9 points higher in the CBA group (95% CI: 5.5 –14.2, P <0.001). Clinically important improvements in the SF-36 physical and mental component scores were observed at 12 months in both groups, with no significant between group differences at this timepoint. In the CBA vs AAD group, larger improvements in EHRA class were observed at 6, 9 and 12 months (P <0.05) and the incidence rate of symptomatic palpitations was lower (4.6 vs 15.2 days/year post-blanking; IRR: 0.30, P <0.001).

Conclusions

In patients with symptomatic AF, first-line CBA was superior to AAD for improving AF-specific QoL and symptoms.

Trial registration

ClinicalTrials.gov number: NCT01803438.

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© 2021  Pubblicato da Elsevier Masson SAS.
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