Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5

Individualized of fixed approach for pulmonary vein isolation utilizing the fourth generation cryoballoon: The randomized INDI-FREEZE trial
C.-H. Heeger1, R. Saraei2, C. Eitel2, M. Feher2, S. Hatahet2, G. D´Ambrosio2, H. L. Phan1, J. Vogler1, K.-H. Kuck3, R. R. Tilz1
1Medizinische Klinik II / Kardiologie, Angiologie, Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Lübeck; 2Med. Klinik II / Kardiologie, Elektrophysiologie, Universitätsklinikum Schleswig-Holstein, Lübeck; 3Kardiologie, LANS Cardio Hamburg, Hamburg;

Aims: Cryoballoon (CB) based pulmonary vein isolation (PVI) is a widely used technique for treatment of atrial fibrillation (AF); however the ideal energy dosing has not yet been standardized. This was a single-center randomized clinical trial aiming at assessing the safety, acute efficacy, and clinical outcome of an individualized vs. a fixed CB ablation protocol using the fourth-generation CB (CB4) guided by pulmonary vein (PV) potential recordings and CB temperature.

Methods: Patients were randomized in a 1:1 fashion to two different dosing protocols: INDI-FREEZE group (individualized protocol): freeze-cycle duration of time to effect plus 90 seconds or interruption of the freeze-cycle and repositioning CB if a CB temperature of -30°C was not within 40 seconds. Control group (fixed protocol): freeze-cycle duration of 180 seconds. No bonus freeze-cycle was applied in either patient group. The primary end point was freedom from atrial tachyarrhythmia at 12 months. Secondary end points included procedural parameters and complications.

Results: A total of 100 patients with paroxysmal AF were prospectively enrolled. No difference was seen in the primary end point (INDI-FREEZE group: 38/47 (81%) vs control group: 40/47, (85%), p=0.583). The total freezing time was significantly shorter in the INDI-FREEZE group (157±56s vs. 212±83s, p<0.001), while procedure duration (57.9±17.9min vs. 63.2±20.2min, p=0.172) was similar. No differences were seen in the minimum CB and esophageal temperatures as well as in periprocedural complications.

Conclusion: Compared to the fixed protocol, the individualized approach provides a similar safety profile and clinical outcome, while reducing the total freezing time.


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