Durability of Pulmonary Vein Isolation with Cryoballoon Ablation: Results from the Sustained PV Isolation with Arctic Front Advance (SUPIR) Study
Language English Country United States Media print-electronic
Document type Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't
PubMed
25644659
DOI
10.1111/jce.12626
Knihovny.cz E-resources
- Keywords
- atrial fibrillation, cryoablation, cryoballoon, pulmonary vein isolation, recurrence,
- MeSH
- Action Potentials MeSH
- Time Factors MeSH
- Equipment Design MeSH
- Electrophysiologic Techniques, Cardiac MeSH
- Esophagoscopy MeSH
- Atrial Fibrillation diagnosis physiopathology surgery MeSH
- Cryosurgery adverse effects instrumentation MeSH
- Middle Aged MeSH
- Humans MeSH
- Non-Randomized Controlled Trials as Topic MeSH
- Prospective Studies MeSH
- Recurrence MeSH
- Aged MeSH
- Cardiac Catheters * MeSH
- Pulmonary Veins physiopathology surgery MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Research Support, Non-U.S. Gov't MeSH
- Geographicals
- Czech Republic MeSH
INTRODUCTION: Pulmonary vein (PV) reconnection remains the most important cause of AF recurrence after AF ablation. The second-generation cryoballoon catheter's ability to achieve durable PV isolation was assessed in a prospective nonrandomized clinical trial. METHODS AND RESULTS: PV isolation was performed by 4-minute ablations. Following verification of electrical isolation by a multielectrode mapping catheter, 1 additional lesion per PV was applied. Esophageal temperatures were monitored and all patients underwent postprocedure esophageal endoscopy. All patients underwent a second PV remapping procedure at ∼3 months to assess for PVI durability. Eighty-four (100%) veins were acutely isolated using only the 28 mm cryoballoon in 21 consecutive PAF patients with 2.2 ± 0.6 cryoapplications per vein, with the majority (83%) occurring after a single freeze. One patient presented with hematemesis and an esophageal ulceration that was treated conservatively; there were no episodes of esophageal fistula or phrenic nerve palsy. At 3.4 (2.9-4.1) months postablation, 68/75 veins (91%) remained electrically isolated; all PVs remained durably isolated in 79% of patients. Two patients accounted for 5 of 7 reconducting veins. The most common site for reconnection was the inferior aspect of the RIPV (3/7 reconnections). Reconnected veins had poorer occlusion at the index ablation procedure than veins that maintained chronic isolation (occlusion grade 2.9 ± 0.7 vs. 3.4 ± 0.7, P = 0.001). Clinical AF recurrence was detected in 2 patients (11%) at follow-up. CONCLUSIONS: The improved thermodynamic characteristics of the second-generation cryoballoon led to a high rate of both single-shot PVI and chronic lesion durability. This high rate of durable PV isolation is anticipated to translate to improved clinical outcome.
Cardiac Arrhythmia Service of the Mt Sinai Hospital New York New York USA
EMEA Regional Clinical Center Medtronic Clinical Research Institute Milan Italy
References provided by Crossref.org
ClinicalTrials.gov
NCT01645917
