Becker's Hospital Review

21 Executive Briefing As a global leader in medical technology, services and solutions, Medtronic improves the health and lives of millions of people each year. We believe our deep clinical, therapeutic and economic expertise can help address the complex challenges — such as rising costs, aging populations and the burden of chronic disease — faced by families and health- care systems today. But no one can do it alone. That's why we're committed to partnering in new ways and developing powerful solutions that deliver better patient outcomes. time being misdiagnosed with other conditions such as anxi- ety. Once diagnosed with AF, patients in the U.S. are required to undergo drug therapy as a first-line treatment. However, if a patient is drug refractory, their physician may move them toward ablation therapy. This presents the second opportunity to improve care. An ear- lier ablation intervention in indicated patients can significantly improve outcomes because of the progressive nature of AF. The data shows that only 4 percent of patients who are candi- dates for catheter ablation treatment are actually being treated. Lastly, patients and providers can improve outcomes by choos- ing safe and effective procedures and technologies that deliver predictable outcomes. Studies have proven both forms of catheter ablation — radiofre- quency and cryoballoon — are more effective than drug thera- pies. Radiofrequency ablation procedures use a single catheter to burn away problematic tissue point-by-point around each of the four pulmonary veins, electrically isolating the arrhythmia from the rest of the heart's left atrial chamber. Cryoballoon ab- lation is a newer and simpler take on this procedure: it involves delivering a single, cold shot to create lesions around the pul- monary veins to isolate the arrhythmia. In addition to its ease of delivery and predictable procedure times, cryoballoon therapy has been shown to reduce the chance of cardiovascular rehospitalization and reduce repeat procedures as compared with radiofrequency therapy. In the FIRE AND ICE clinical trial comparing the two procedures, cryo- balloon ablation was associated with 34 percent fewer cardio- vascular rehospitalizations and 33 percent fewer repeat abla- tions after the index procedure. Economic impact of cryoballoon technology Cryoballoon technology could offer hospitals treating patients with AF meaningful improvements to their standard practice. The value of cryoballoon technology can be broken down into two main buckets: how well the procedure optimizes cost and efficiencies, and how well it can lead to effective outcomes for indicated patients. The efficiencies associated with cryoballoon therapy repre- sent an opportunity for cost savings, according to Mr. Mody. Clinical data has shown that the procedure is efficient and pre- dictable, plus it offers flexibility in sedation choice. Compared to the radiofrequency procedure, which is usually performed under general anesthesia, cryoballoon therapy can be per- formed under moderate sedation. This may allow clinicians to conduct the procedure more quickly and schedule it more easily, without having to coordinate appointments with the general anesthesia team. Cryoballoon ablation is also more consistent in terms of pro- cedure time, which helps labs run more predictable schedules, reduce number of staff and create extra capacity. In an event simulation analysis, published in The Journal of Invasive Cardi- ology, the procedure was shown to reduce days of overtime lab usage by 36 percent and reduce overtime hours by 93 percent, compared to radiofrequency ablation. The second bucket of cost savings involves reducing costs by improving outcomes. Cryoballoon therapy is associated with a 21 percent reduction in payer cost compared to radiofrequen- cy therapy, according to a study examining the economic im- pact of clinical improvements. Mr. Mody noted that in the land- mark FIRE AND ICE clinical trial, this rounds out to the potential for significant payer savings of $925 per patient over the trial period, which stems from a reduction in repeat ablations, car- dioversions and hospitalizations. With more than 100,000 ablations performed in the U.S. each year, the potential savings could be substantial. Conclusion AF is difficult to treat, resulting in significant costs for hospitals and the U.S. healthcare system. However, early treatment with catheter ablation for indicated patients may yield clinical ben- efit over drug therapy. Based on past randomized trials, cryob- alloon ablation has been shown to produce similar outcomes specific to clinical efficacy and safety when compared with the more traditional radiofrequency ablation. However, according to the FIRE AND ICE trial, cryoballoon ablation also was associ- ated with fewer repeat ablations and rehospitalizations, which may create significant cost savings for the healthcare system and are important clinical outcomes for patients. n With more than 100,000 ablations performed in the U.S. each year, the potential savings could be substantial.

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