Change search
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
Acute and long-term efficacy and safety with a single cryoballoon application as compared with the standard dual application strategy: a prospective randomized study using the second-generation cryoballoon for pulmonary vein isolation in patients with symptomatic atrial fibrillation
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
Show others and affiliations
2018 (English)In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 20, no 10, p. 1598-1605Article in journal (Refereed) Published
Abstract [en]

Aims

A single cryoballoon (CB) application per vein for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF) could save time and was therefore compared to the standard approach of two consecutive CB applications for acute and long-term efficacy and safety.

Methods and results

Patients with symptomatic AF were randomized to a single CB application per vein guided by an Achieve® catheter (Single cryo-arm) or to two CB applications using a standard guidewire (Routine cryo-arm). The primary endpoint was the rate of acute complete PVI. Secondary endpoints were freedom from AF evaluated by electrocardiogram and 7 days Holter at 6 and 12 months, symptoms by Symptom Severity Questionnaires and EHRA score and quality of life (QoL) by EQ5D-5L at 12 months. Among 140 patients included, PVI was achieved in 271 (100%) veins in the Single cryo-arm and in 269/271 (99.3%) veins in the Routine cryo-arm, P = 0.25. The procedure time was shorter in the Single cryo-arm, mean ± standard deviation 99.4 ± 33.3 min vs. 118.4 ± 34.3 min, P = 0.0015. Freedom from AF after one procedure at 12 months did not differ; 73.9.0% (Single cryo) vs. 71.4% (Routine), P = 0.74. Symptoms and QoL did also not differ between the two groups. There was a lower complication rate in the Single cryo-group, 2.9% vs. 12.9%, P = 0.03.

Conclusion

A single CB application shortens the procedure time without affecting acute or long-term efficacy, as compared to the routine two-application strategy, which with the lower complication rates has important implications when defining standards for PVI.

Place, publisher, year, edition, pages
2018. Vol. 20, no 10, p. 1598-1605
Keywords [en]
Atrial fibrillation, Ablation, Pulmonary vein isolation, Cryoballoon, Achieve®
National Category
Cardiac and Cardiovascular Systems
Research subject
Cardiology
Identifiers
URN: urn:nbn:se:uu:diva-362206DOI: 10.1093/europace/euy014ISI: 000450397600009OAI: oai:DiVA.org:uu-362206DiVA, id: diva2:1252624
Funder
Swedish Heart Lung Foundation, 20150751Swedish Research Council, 2014-36708-117759-70Available from: 2018-10-02 Created: 2018-10-02 Last updated: 2019-01-22Bibliographically approved
In thesis
1. Outcomes and safety of new techniques for pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation: A study based on randomised trials and registries
Open this publication in new window or tab >>Outcomes and safety of new techniques for pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation: A study based on randomised trials and registries
2018 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Atrial fibrillation (AF) is a common disease with a high prevalence in the adult population. Treatment of AF encompasses antiarrhythmic drugs and catheter ablation to reduce symptoms. The aim of this thesis was to study how to best alleviate symptoms of AF in a safe and efficient way comparing pharmacological treatment and the two dominating catheter ablation techniques, cryoballoon (CRYO) ablation and point-by-point radiofrequency (RF) ablation.

Quality of life improved more for those AF patients randomised to treatment with catheter ablation compared to those treated with antiarrhythmic medication after 12 months of follow up (n=155).

We evaluated a proposed optimised CRYO ablation protocol and randomised 140 patients to a single cryoballoon application per vein guided by a mapping catheter (Single cryo) or two cryoballoon applications (Routine). Acute pulmonary vein isolation rate did not differ. Procedure time decreased by 19 minutes with a lower complication rate in the Single cryo-arm. Freedom from AF after one procedure at 12 months did not differ; 73.9.0% (Single cryo) versus 71.4% (Routine).

CRYO ablation was also assessed in persistent AF and paroxysmal AF. Freedom from arrhythmia recurrence was lower after a single ablation in persistent AF (64.9%) compared with paroxysmal AF (82.2%) after 12 months. However, the reduction of AF symptoms and quality of life was excellent in both groups and did not differ after 12 months.

Patients undergoing their first AF ablation with CRYO or RF were included in a registry study. After 12 months, freedom from AF was equal irrespective of AF type, but there was a lower re-ablation rate and need for continued antiarrhythmic drug treatment after CRYO ablation. Procedure duration was reduced by 40 minutes with CRYO and complication rates did not differ,

In conclusion, catheter ablation reduces AF symptoms more than antiarrhythmic drugs and cryoballoon ablation can be further optimised with reduced procedure times and improved safety. Cryoballoon ablation is as efficacious as RF ablation as a first-line therapy in both paroxysmal and persistent AF and the lower re-ablation rates and  shorter procedure times may have important clinical implications when choosing AF ablation technique.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2018. p. 81
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1509
Keywords
atrial fibrillation, antiarrhythmic drugs, ablation, cryoballoon, radiofrequency, pulmonary vein isolation, quality of life, arrhythmia monitoring, implantable cardiac monitor, atrial fibrillation burden, health economics
National Category
Cardiac and Cardiovascular Systems
Research subject
Cardiology
Identifiers
urn:nbn:se:uu:diva-363259 (URN)978-91-513-0486-1 (ISBN)
Public defence
2018-12-05, Enghoff-salen, Akademiska sjukhuset, ingång 50, bv, Uppsala, 13:00 (English)
Opponent
Supervisors
Available from: 2018-11-14 Created: 2018-10-16 Last updated: 2018-11-30

Open Access in DiVA

No full text in DiVA

Other links

Publisher's full text

Search in DiVA

By author/editor
Mörtsell, DavidMalmborg, HelenaLönnerholm, StefanBlomström-Lundqvist, Carina
By organisation
Cardiology-Arrhythmia
In the same journal
Europace
Cardiac and Cardiovascular Systems

Search outside of DiVA

GoogleGoogle Scholar

doi
urn-nbn

Altmetric score

doi
urn-nbn
Total: 28 hits
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf