April 13, 2020Journal of Interventional Cardiac ElectrophysiologyOpen Access

Reducing radiation exposure in second-generation cryoballoon ablation without compromising clinical outcome

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Why the study?

CB PVI involves increased radiation exposure compared with radiofrequency ablation, and the mid-term clinical outcome of reducing radiation through a modified fluoroscopy protocol needed evaluation.

Does a modified fluoroscopy protocol reduce radiation exposure without compromising clinical efficacy in patients undergoing second-generation cryoballoon ablation for atrial fibrillation?

Structured PICO

Does a modified fluoroscopy protocol reduce radiation exposure without compromising clinical efficacy in patients undergoing second-generation cryoballoon ablation for atrial fibrillation?

Population

90 consecutive patients with atrial fibrillation (paroxysmal, persistent, or long-standing persistent) who underwent second-generation cryoballoon-based pulmonary vein isolation (PVI).

Intervention

Modified fluoroscopy protocol consisting of visualization of the degree of pulmonary vein occlusion only by fluoroscopy (no cine runs) and increased radiation awareness (e.g., optimal collimation, minimizing distance between patient and detector, limiting fluoroscopy) during cryoballoon ablation (n=44).

Comparator

Conventional fluoroscopy settings including cine runs to visualize the degree of pulmonary vein occlusion prior to each freeze cycle during cryoballoon ablation (historic control group, n=46).

Outcome

Total dose area product (DAP), total fluoroscopy time, and 1-year freedom from documented recurrence of atrial fibrillation (AF) lasting longer than 30 seconds after a single procedure.surrogate

Implementing a modified fluoroscopy protocol without cine runs significantly reduces radiation exposure during cryoballoon ablation for atrial fibrillation without compromising procedural success or 1-year clinical outcomes.

Limitations

Observational nature of the study may introduce bias, as evidenced by differences in baseline characteristics (sex and LA diameter) between groups.
Did not systematically collect data on the number of pulmonary veins which showed small leaks during balloon occlusion.
Single-center study with a limited number of patients which may impact the generalizability of the results.

Implication

Modified fluoroscopy may lower radiation in CB PVI; hypothesis-generating and requires randomized confirmation before practice change.

Abstract

PURPOSE: Pulmonary vein isolation (PVI) using cryoballoon (CB) ablation is associated with an increased radiation exposure compared with radiofrequency ablation. Previous studies showed that radiation exposure in CB PVI can be reduced by optimizing the fluoroscopy protocol without comprising acute efficacy and safety. We evaluated the mid-term outcome of a modified fluoroscopy protocol in patients undergoing CB PVI. METHODS: The study population comprised 90 consecutive patients who underwent second-generation CB-based PVI. The first 46 patients underwent CB PVI with conventional fluoroscopy settings (group A, historic control group). In the following 44 patients (group B), a modified fluoroscopy protocol was applied consisting of (1) visualization of degree of PV occlusion only by fluoroscopy (no cine runs); (2) increased radiation awareness. Primary endpoints were the total dose area product (DAP), fluoroscopy time, and freedom from documented recurrence of atrial fibrillation (AF) after a single procedure. RESULTS: , P < 0.001) and median fluoroscopy time (20 min vs. 24 min, P < 0.001) as compared with group A. The 1-year freedom from documented recurrence of AF after a single procedure was similar among groups (74% in group A vs. 77% in group B, P = 0.71). There were no significant differences between both groups for the secondary endpoints, including procedure duration, proportion of patients with complete electrical isolation, and complications. CONCLUSION: Using a modified fluoroscopy protocol and increased radiation awareness, radiation exposure can be significantly reduced in CB PVI with a similar 1-year clinical outcome.