Emilia Romagna Region published a rapid assessment report on the cardiac cryoablation catheter (also known as cryoballoon) for atrial fibrillation (AF). The authors concluded that, compared to radiofrequency ablation, cryoablation is not linked to higher effectiveness but presents shorter procedural time.
Introduction
Atrial fibrillation (AF) in Italy has an estimated prevalence of 2%, with 55.1% of patients presenting permanent AF, 24.3% presenting persistent AF, and 20.1% presenting paroxysmal AF. Initial treatment is pharmacological but ablation procedures can also be performed to manage cardiac rhythm. Transcatheter ablation can be performed by radiofrequency ablation or cryoablation. Medtronic is the only company that offers a cryoballoon for AF, the Arctic Front® Cardiac Cryoablation Catheter. Three different product generations are available with Arctic Front Advance ST® being the latest. The average unit price for the cryoballoon in Italy is 4,000 EUR. The author estimated that 220 patients within the Region would be eligible for the use of this technology.
Methods
The assessment was developed around the following elements:
§ Population: Subjects with paroxysmal AF or persistent AF eligible for pulmonary vein isolation (PVI) by transcatheter ablation not previously treated with ablative techniques;
§ Intervention: Cryoballoon PVI;
§ Comparator: Radiofrequency PVI;
§ Outcomes: Effectiveness (AF symptoms management, need for re-intervention, etc.), Safety (peri-procedural complications and post-procedural adverse events), and Technical performance (procedural time, success rate, etc.);
§ Time of follow-up: 12 months (excluding blanking, i.e., 90 days after the ablation procedure);
- Study design: Secondary studies (HTA reports and systematic reviews), Primary studies (RCTs and controlled observational studies with at least 10 subjects; data from device surveillance considered for safety assessment), and ongoing studies.
Results
Two systematic reviews from 2016 were included but results were in disagreement. A meta-analysis of primary studies was then performed.
For paroxysmal AF, 29 primary studies were included (6 of which were RCTs) for a total of 11,635 patients. No differences between cryoablation and radiofrequency ablation were identified in the effectiveness outcomes. Compared to radiofrequency ablation, the use of cryoablation was linked to a reduced risk of pericardial effusion and cardiac tamponade but also to an increased risk of damage to the phrenic nerve. A shorter procedural time was linked to the use of cryoablation versus radiofrequency ablation.
For persistent AF, only 2 primary studies were included (none of them was a RCT) for a total of 218 patients. While no differences in effectiveness outcomes were identified, adverse events occurred only in patients treated with radiofrequency ablation and procedural times were shorted with cryoablation.
Among the 21 ongoing studies identified, 16 studies involve paroxysmal AF patients.
See the full report in Italian here.
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