Today in Medicine: NY Times Describes Health and Economic Impact of Ablation for A Fib

NY Times Describes Health and Economic Impact of Ablation for A Fib

July 10, 2007 by Grendel Burrell [mailto:grendel.burrell@gmail.com]

In the Sunday, July 8, edition of the New York Times, the most common cardiac arrhythmia is highlighted with the spotlight placed on the economic impact of atrial fibrillation (AF). Atrial fibrillation is the most common sustained cardiac arrhythmia observed in clinical practice and is associated with increased morbidity and mortality, resulting from stroke and exacerbation of heart failure. To date, there is a lack of pharmacologic agents to safely and effectively convert the arrhythmia to sinus rhythm.

Defining and diagnosing AF may be easier than managing the burgeoning numbers of patients with this condition. The NY Times cites figures of an estimated 2.2 million patients in the US with symptoms ranging from shortness of breath or weakness to the risk of thromboembolism and stroke. The AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) study was across-sectional evaluation of 1.89 million US adults (≥20 years of age) whose AF was diagnosed between July 1, 1996, and December 31, 1997 (1). The goal of the study was to determine the prevalence of AF and to project the number of people in the United States who would exhibit AF between 1995 and 2050. At the time of the study’s conclusion, approximately 2.3 million US adults had AF, and 10.5% of those patients were ≥80 years of age. Projections indicated that >5.6 million Americans would be afflicted by 2050, and more than 50% of those would be ≥80 years of age. So, whether the number of patients in the US alone is 2.2 million, 2.3 million, or closer to 5.6 million, questions remain about how to pay for atrial fibrillation- medication and hospitalizations, the device-based therapy, atrial ablation, and future therapies.

The New York Times article reports that “thousands” of patients have undergone atrial ablation for atrial fib. Dr. Matthew Reynolds, an electrophysiologist at Beth Israel Deaconess Medical Center, Boston, MA and Medical Director of Economics and Quality of Life Research at the Harvard Clinical Research Institute, cites data that he and colleague presented at the May 2007 meeting of the heart Rhythm Society, “We estimated that > 2000 ablations were performed on Medicare patients in 2005. Not only is the number of procedures rapidly rising, but the number of hospitals providing this therapy increased from 242 to 453 institutions within a period of 5 years, and there are likely many more offering the procedure now.”

Dr. Peter Zimetbaum, an electrophysiologist at Beth Israel Deaconess Medical Center, Boston, MA and an Associate Professor in the Department of Medicine, Harvard Medical School told WikiDoc, “Non pharmacological approaches to AF management including percutaneous pulmonary vein isolation are increasingly performed to reduce the frequency and in some cases cure atrial fibrillation. The long-term success of these procedures is not yet known but short-term outcomes suggest a 70% improvement in pre procedure arrhythmia frequency. These procedures are technically challenging and very costly.” While atrial ablation is less invasive than open-heart surgery and the health economic analysis indicates that this curative procedure may be efficacious when compared to a lifetime of pharmacologic therapies, ablation has implications for Medicare and for private insurers. Adding to the cost is the fact that approximately 30% of patients require a second ablation. The volume of patients and the ablation procedure are on the FDA radar screen for additional review. The FDA plans to schedule a meeting with medical and pharma- and device-experts to discuss the facts and the questions about drugs and devices being used “off label” to manage atrial fibrillation.

Equipment costs for the catheter-based procedure run $4000-5000 per patient. Total billing for the hospital and physicians are $25-50,000, according to the NY Times. Physicians at Beth Israel Deaconess Medical Center, Boston, MA assessed the costs associated with the procedure and found the numbers to be ~ $15-20,000. Doctors and hospitals bill Medicare or insurers under codes for “somewhat similar cardiac procedures “ as stated in the Times article. Yet reimbursement falls short of the billed dollars. “Some insurers are using the lack of an FDA approved product as justification for labeling the procedure ‘experimental’ and therefore not covering it. Clinical trials are in the late phases of enrollment, and small studies have demonstrated the benefit of ablation, but the lack of a specific billing code is an issue in that hospitals have to do extra work to obtain reimbursement anywhere close to the cost. Support varies form insurer to insurer,” commented Dr. Reynolds.

Pharmacologic therapy for an AF patient, using generic drugs, costs approximately $1000/year. However, this does not account for the hospitalizations, blood tests, physician visits, and life style restrictions. Clearly, drug therapies are not a “cure”. Drug therapies are not without their own inherent risks. Amiodarone is implicated in the development of heart failure, can cause muscle tremors, and lung and liver damage. Warfarin raises the risk of bleeding and requires frequent tests and dose adjustments. Intravenous vernakalant, not yet commercially available, may, if approved, provide a new approach to the acute conversion of AF (2). When discussing approaches to management of atrial fib, Dr. Zimetbaum added, “Minimally invasive surgical approaches to pulmonary vein isolation are also being developed. These procedures have the added benefit of left atrial appendage exclusion (which might reduce stroke risk) and are reimbursed under surgical codes, which, at present, are profitable for hospitals.”

When to give up on drug therapy and move to ablation? Dr. Reynolds' perspective on this issue is that there is “…no single answer. When the objective is rhythm control, it usually doesn’t make sense to go beyond 2 trials with antiarrhythmic drugs since the chance of success with drugs beyond this point is pretty low. Failure of 2 or more drugs has been an enrollment criterion in many ablation studies to date.” But answers on cost effectiveness of ablation in the overall AF patient population are still needed. “In one recent study from the University of Michigan, authored by Paul Chan and colleagues (3), radiofrequency ablation therapy for atrial fibrillation was found to be cost-effective in patients with moderate stroke risk ($49,000 per quality-adjusted life-year) but not in patients at low stroke risk ($99,000 per quality-adjusted life-year). However, these findings were highly sensitive to assumptions regarding the true efficacy of ablation therapy and the benefit of sinus rhythm restoration on reducing long-term stroke risk-- both of which are virtually unknown at the present time. Until adequately powered trials are conducted to assess stroke and mortality risk reduction, the cost-effectiveness of ablation therapy for atrial fibrillation remains largely untested,” stated Dr. David Cohen, Director of Cardiovascular Research, St. Luke’s Mid America Heart Institute, and Professor of Medicine, University of Missouri-Kansas City.

While professional societies such as the Heart Rhythm Society (http://www.hrsonline.org/News/Media/press-releases/upload/HR-and-Euro-Copy-for-Print.pdf), endorse atrial ablation as standard care for patients unresponsive to drug therapy, it appears that physicians would further embrace ablation for their AF patients if technology could reduce the procedure time from 4 to 2 hours, and if insurance coverage was improved. The NY Times article provides examples of patients with excellent results and states that schedules for physicians doing ablations at the Cleveland Clinic are booked months in advance. Questions remain as to how the system can support the demand for the procedure and how the procedure can be made available to patients outside of major academic institutions while considering the costs and cost effectiveness analysis.

What is atrial fibrillation?
Atrial fibrillation is an irregularly irregular heart beat. The American College of Cardiology, American Heart Association, and the European Society of Cardiology define atrial fibrillation as a supraventricular tachyarrhythmia characterized by uncoordinated atrial activation with consequent deterioration of atrial mechanical function. On an electrocardiogram, AF is characterized by the replacement of P waves with rapid oscillations or fibrillatory waves of varying size, shape, and timing (4).