Cryoablation System Stops Arrhythmia in its Tracks

The Medtronic Arctic Front CryoAblation catheter system uses a coolant that is released into the catheter's balloon, causing the balloon to freeze and ablate the tissue, thus allowing the rapid formation of continuous cryoablation lesions at the pulmonary vein (PV) ostia. The system is comprised of the Arctic Front cryoballoon catheter, which inflates and fills with coolant to ablate between the PV and the left atrium; the FlexCath steerable sheath, which helps deliver and position the cryocatheter in the left atrium; the Freezor MAX Cardiac cryoAblation catheter, which is a single-point catheter used to provide additional ablations; and the CryoConsole, which houses the coolant, electrical, and mechanical components that run the catheter during a cryotherapy procedure. Pre-clinical data have demonstrated long-term effectiveness of the balloon cryoablation for permanent electrical isolation of the PVs with low risk of PV stenosis. Results from these studies suggest that no pulmonary venous stenosis and no thromboembolic incidents have occurred even with multiple four or eight-minute long procedures. The Medtronic Arctic Front CryoAblation catheter system is a product of Medtronic (Minneapolis, MN, USA), and has been approved for use in Europe, Australia, and Hong Kong, and is under investigational use in the United States.

"This catheter is designed to allow physicians to more efficiently and easily ablate than with a single tip ablation procedure,” said Kevin Wheelan, M.D., chief of staff at Baylor Heart and Vascular (Dallas, TX, USA), and an investigator in the Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP-AF) clinical trial evaluating the system. "In this trial, the cryoballoon's stability simplified the process for these types of cardiac ablation procedures.”

AF is a common and disabling cardiac arrhythmia. In addition to hemodynamic compromise and higher mortality rates, AF patients suffer an increased risk of systemic emboli arising from the left atrium. The risk of stroke in patients with nonvalvular AF is 5 to 7 times greater than in comparable patients without AF; overall, 20 - 25% of ischemic strokes are due to cardiac emboli, of which half arise in patients with nonvalvular AF. In addition to such proven mortality and morbidity risks, AF is associated with a substantial burden of symptoms, stemming from the arrhythmia itself, exacerbation of comorbid conditions such as chronic heart failure (CHF), associated anxiety over possible sequelae, as well as the substantial burden of side effects from antiarrhythmic drugs used to treat AF; currently available treatments are unsatisfactory for many patients. AF drug treatment has a relatively low efficacy, even in patients suffering from paroxysmal atrial fibrillation (PAF), with frequent recurrences and a high incidence of intolerable drug side effects.

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