por John R. Fischer
, Senior Reporter | August 03, 2017
Medtronic Arctic Front and Arctic
Front Advance Cryoballoon
A health economic analysis is outlining cryoballoon catheter ablation as a cost-saving alternative for treating atrial fibrillation and paroxysmal atrial fibrillation with safer outcomes, compared to radiofrequency ablation.
The report, published in the Journal of the American Heart Association
, found that patients treated with cryoballoon ablation experienced less repeat ablations and cardiovascular rehospitalizations, thereby saving more in expenses, compared to those who underwent radiofrequency ablation for treatment. It also found those who used cryoballoon ablation also helped their native health care systems financially in trial costs.
The findings were compiled as part of the FIRE AND ICE trial, a study sponsored by Medtronic that focuses on comparisons between its Arctic Front and Arctic Front Advance Cryoballoon brand and radiofrequency ablation through Biosense Webster’s ThermoCool line of RF ablation catheters for treating AF and PAF.
Cryoballoon ablation is a minimally-invasive procedure that freezes abnormal heart tissue using cold energy to disrupt unwanted electrical signals in the heart that cause AF and PAF. Radiofrequency uses heat to disrupt the signals.
The trial consisted of 750 patients in which 374 received treatment via cryoballoon ablation and 376 via radiofrequency ablation. All were then monitored for a year and a half following the treatment to assess the need for hospitalization and intervention.
Of the number that used cryoballoon ablation, 122 patients together experienced 205 hospitalizations and/or interventions, compared to 154 radiofrequency patients who required 268.
The trial tested patients in Germany, the U.K. and the U.S. Each German patient using cryoballoon ablation saved an average of €640 with the German health care system saving €245,000 in trial costs. U.K. patients saved £364 per person with the British health care system saving £140,000. American patients saved $925 each, thereby saving the U.S. healthcare system a total of $355,000.
Cryoballoon ablation has been used for 10 years to treat over 250,000 AF and PAF patients in more than 50 countries, though radiofrequency ablation is still the standard procedure since it has been around for decades, according to Medtronic.
Tracy McNulty, a Medtronic spokesperson, told HCB News that cryoballoon catheter ablation could become a standard alternative to radiofrequency ablation.
“The landmark FIRE AND ICE trial, from which this specific economic analysis was run, showed that the Medtronic cryoballoon is comparable to radiofrequency ablation in terms of safety and efficacy but with the added patient and health care system benefits of fewer repeat ablations and fewer rehospitalizations,” she said. “So, yes, we believe this trial shows that cryoballoon ablation should be considered a gold standard for treating patients with paroxysmal AF.”
The FDA has approved the Medtronic Arctic Front and Arctic Front Advance Cryoballoon brand as a treatment for drug refractory, symptomatic paroxysmal atrial fibrillation in the U.S. The brand is approved in Europe for treating atrial fibrillation.