Atrial fibrillation, a rapid and irregular heartbeat, is putting a growing number of Americans at risk of heart failure and stroke, and in turn dramatically increasing the clinical and financial burden on U.S. hospitals.
The condition affects more than 3.5 million Americans, but the likelihood of developing AF increases with age, so it disproportionately affects seniors. Roughly one in 25 U.S. adults over age 60 has AF, with the rate increasing to one in 10 Americans over age 80. As the population ages and other risk factors such as obesity, hypertension, diabetes and cardiovascular disease continue to grow, the prevalence of AF is expected to double by 2035.
This content is sponsored by Medtronic
While the condition itself is not life threatening, AF seriously impacts one's health by increasing the likelihood of stroke five times and increasing the risk of heart failure three times. In fact, 17 percent of all patients admitted to hospitals in the U.S. have some type of arrhythmia, or irregular heart rhythm. And once admitted for a stroke or heart failure, patients with AF don't fare as well as non-AF patients. The condition doubles the rate of death from stroke, and increases the risk of morbidity and mortality from heart failure.
Treating patients with AF proves complex and costly for hospitals. Fortunately, hospitals have several opportunities to reduce costs and improve outcomes for patients with arrhythmia.
During a webinar hosted by Becker's Hospital Review, Hae Lim, PhD, senior principal scientist, and Mark Burton, director of market access at Medtronic, reviewed the clinical and economic burden of AF, outlined potential opportunities to improve care and compared the economic impact of various treatments. Samir Mody, vice president for Healthcare Economics and Reimbursement at Medtronic, expanded on those sentiments.
AF's burden on hospitals and the U.S. healthcare system
AF patients put greater financial pressure on hospitals than non-AF patients. AF patients are twice as likely as non-AF patients to be hospitalized for any reason, four times as likely to be hospitalized for cardiac events and eight times as likely to have multiple cardiovascular hospitalizations.
Medtronic estimates the average hospital has anywhere from 100 to 200 admissions with a primary diagnosis of AF during a single year. Because of the risks associated with treating AF and the prevalence of the condition, this takes a financial toll on the U.S. healthcare system, costing roughly $26 billion per year. On a per-patient level, the average patient with AF incurs a net annual incremental cost of about $8,700, which is 73 percent more than the healthy population, according to Mr. Mody. For AF patients with a history of heart failure, those costs can grow upwards of $33,000.
Mr. Mody relayed the burden of AF hospitalizations on hospital and payer finances and said Medtronic is focusing on this patient population and investing in technology to stem the tide of this condition.
Opportunities to improve clinical care and outcomes
"Patients with AF have a significantly lower quality of life," Mr. Mody said. "It cuts across all dimensions of health and physical wellbeing."
Two main treatment pathways exist for AF patients: reduce the risk of stroke and/or manage symptoms. For stroke prevention, drug-based therapy, such as warfarin and novel oral anticoagulants, can prevent the formation of additional blood clots. Patients who cannot manage stroke risk with drugs may choose to undergo an invasive surgical procedure that closes off the left atrial appendage, where blood clots often form during irregular heartbeats.
As for managing AF symptoms, patients usually start with drug therapy and are ramped up as necessary. Following drug therapy, other options for some types of AF include catheter and surgical ablation, both of which destroy heart tissue and the associated electrical activity causing arrhythmias. AF is complex, but hospitals and clinicians have three main opportunities to improve clinical AF care. The first is an expedient, accurate diagnosis. Patients may spend considerable time being misdiagnosed with other conditions such as anxiety.
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 earlier 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 candidates for catheter ablation treatment are actually being treated.
Lastly, patients and providers can improve outcomes by choosing safe and effective procedures and technologies that deliver predictable outcomes.
Studies have proven both forms of catheter ablation — radiofrequency and cryoballoon — are more effective than drug therapies. 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 ablation is a newer and simpler take on this procedure: it involves delivering a single, cold shot to create lesions around the pulmonary 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, cryoballoon ablation was associated with 34 percent fewer cardiovascular rehospitalizations and 33 percent fewer repeat ablations 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 represent an opportunity for cost savings, according to Mr. Mody. Clinical data has shown that the procedure is efficient and predictable, plus it offers flexibility in sedation choice. Compared to the radiofrequency procedure, which is usually performed under general anesthesia, cryoballoon therapy can be performed 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 procedure 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 Cardiology, 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 radiofrequency therapy, according to a study examining the economic impact of clinical improvements. Mr. Mody noted that in the landmark 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, cardioversions 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 benefit over drug therapy. Based on past randomized trials, cryoballoon 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 associated with fewer repeat ablations and rehospitalizations, which may create significant cost savings for the healthcare system and are important clinical outcomes for patients.