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Wednesday, August 24, 2016

Radiosurgery for Atrial Fibrillation

REVIEW ARTICLE 
 PEER-REVIEWED

Cost-Effectiveness of Cardiac Radiosurgery for Atrial Fibrillation: Implications for Reducing Health Care Morbidity, Utilization, and Costs



Abstract

In the United States(U.S.), atrial fibrillation (AF) is the second-most common cardiovascular condition after hypertension, affecting four million Americans each year. Individuals with AF are three times more likely to be hospitalized over the span of a year when compared to medically matched control groups. The considerably large clinical population of individuals with AF mandates that the cost-effectiveness and efficacy of current treatment regimens for AF have egregious implications for health care spending and public health. Unfortunately, catheter ablation for AF treatment has been shown to make only modest gains in quality-adjusted life years, has yet to demonstrate cost-utility advantages over conventional therapies for AF, and has a reported rate of recurrence for AF that is notably high. Thus, there is a major unmet clinical need for a therapeutic option to treat AF that produces more consistent and efficacious results that are cost-effective. Cardiac radiosurgery as a therapy for AF has the potential to be remarkably cost-effective and produce robust patient outcomes. CyberHeart Inc. has developed the world’s first-ever cardiac radiosurgery (CRS) system designed to ablate the heart non-invasively. Procedures that ablate the heart utilizing the Cyberheart CRS system are anticipated to allow higher efficacy and more consistent results than current techniques such as catheter ablation. The aim of this study is to present the current healthcare utilization and expenditures in AF treatment, report the cost-effectiveness of catheter ablation for AF, and project the potential cost-effectiveness of cardiac radiosurgery for the treatment of AF.
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Conclusions

Patients with AF have a multitude of cost determinants and are observed to have notably high health care utilization and expenditures. AF has been reported to account for 350,000 hospitalizations, 5 million office visits, and 276,000 emergency room visits over a one-year period, and is a major driver of healthcare costs in the U.S. and worldwide [26]. In the U.S. it is estimated that AF resulted in $16 billion in costs to Medicare alone for newly diagnosed patients and in the European Union (E.U). It has been approximated that expenditures on AF are more than €13.5 billion [27, 29]. Approximations of the average cost for a patient in the U.S. with AF per year range from $20,613 to $40,169 [28]. Individuals with AF are three times more likely to be hospitalized over the span of a year when compared to medically matched control groups [31]. Consequently, the cost-effectiveness and efficacy of AF treatment are tremendously important for the future of healthcare spending.
There is a major unmet clinical need for a therapeutic option to treat AF that produces more consistent and efficacious results, yielding lower complication rates, and allows treatment to be more cost-effective. Catheter ablation as a therapy to restore sinus rhythm to patients with AF has a reported rate of recurrence that ranges between 50-80% for one to three years after the initial procedure. The reported amount of patients that do not have AF recurrence after undergoing a catheter ablation after five years has been reported to be 59.4% [4, 20, 23, 34]. Because the greater majority of patients that have AF recurrence do not require hospitalization, it is likely that the already notably high recurrence rate of catheter ablation is even higher than the rate of recurrence reported in the literature. Such a high recurrence rate necessitates that repeat ablation procedures are performed to treat AF, which unfortunately have higher risks for complications and increase total costs for patients. Accordingly, studies on the cost-effectiveness of catheter ablation for AF have displayed that it is not economically beneficial or cost-effective as a first-line therapy for patients that are older than 50 years [28, 39].
Cardiac radiosurgery has a tremendous potential to provide therapy for AF that results in improved clinical outcomes that are more cost-effective than current treatment options for AF. CyberKnife SRS has already been established to be cost-effective for the treatment of intracranial neoplasms and cancer metastases located on the body [46, 47, 49]. CyberHeart CRS system is a cutting edge technology that delivers radiation to cardiac targets with impeccable accuracy to non-invasively ablate the heart. Because its proprietary technology allows clinicians to use an anatomic approach and predetermine the exact size and shape of the cardiac ablation on a computer program, procedures that ablate the heart utilizing the Cyberheart CRS system are anticipated to allow higher efficacy and more consistent results than current techniques such as catheter ablation. In addition to providing improved clinical outcomes, CyberHeart procedures for the treatment of AF are projected to be less expensive than catheter ablation procedures. A CyberHeart procedure for AF has an expected Medicare reimbursement of $8,000, which is comparably lower than the reported $12,500 Medicare reimbursement of catheter ablation for AF. The anticipated decrease in costs for a CyberHeart procedure for AF occurs because CRS does not require cardiac anesthesia, cardiothoracic surgical backup, or other support that is required for catheter ablation. While current research is ongoing to further validate the efficacy of the CyberHeart CRS system in an FDA approved clinical investigation, the benefits of non-invasively ablating the heart with CRS to treat AF in a cost-effective manner will undoubtedly have incredible implications that can radically improve the lives of the millions of individuals that suffer from symptomatic AF. 

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