Catheter Approaches Primarily Treat Paroxsymal AF Patients

The figure below illustrates the large unmet market that is not presently being served by catheter ablation procedures. AF is the most common cardiac arrhythmia and its incidence continues to increase as the population ages. In a recent Circulation article, it is estimated that there will be 15 million people with AF by 2050 in the US alone.  As the catheter literature indicates endocardial ablation is most effective on patients with less than 4.5cm atria and less than 60 years old²¹. Generally, these patients have lone (no structural heart disease), paroxysmal AF.
 

 

The Convergent Procedure is designed to address the 76% of AF patients with atria greater than 4.5cm and the 88% of AF patients with structural heart disease. These patients have had few viable treatment alternatives and are not frequently referred by cardiologists to the EPs because of limited ablation treatment success.²²

 

Footnotes:

1. Fuster and Ryden, et al. ACC/AHA/ESC Practice Guidelines, JACC Vol 38, No. 4, October 2001.
2. Verma A, et al. Substrate and Trigger Ablation and Reduction of Atrial Fibrillation (STAR AF): a randomized, multicentre, international trial. European Heart Journal, March 2010.
3. Elayi C, et al. Ablation for longstanding permanent atrial fibrillation: Results from a randomized study comparing three different strategies. Heart Rhythm Society, 2008.
4. Hindricks G, et al. Perception of Atrial Fibrillation Before and After Radiofrequency Catheter Ablation: Relevance of Asymptomatic Arrhythmia Recurrence. Circulation: Journal of the American Heart Association, 112; 307-313. 2005.
5. Jais P, et al. Catheter Ablation Versus Antiarrhythmic  Drugs for Atrial Finrillation: The A4 Study. Circulation: Journal of the American Heart Association, 118, 2498-2505. 2008.
6. Haissaguerre M, et al. Catheter Ablation of Long-Lasting Persistent Atrial Fibrillation: Clinical Outcome and Mechanics of Subsequent Arrhythmias. Journal of Cardiovascular Electrophysiology. Vol. 16, No. 11, November 2005.
7. Kanj, M, et al. Pulmonary Vein Antral Isolation Using and Open Irrigation Ablation Catheter for the Treatment of Atrial Fibrillation. Journal of the American College of Cardiology. Vol. 49, No. 15, 2007.
8. Liu X, et al. Achievement of Pulmonary Vein Isolation in Patients Undergoing Circumferential Pulmonary Vein Ablation: A randomized comparison between two difference isolation approaches. Journal of Cardiovascular Electrophysiology. Vol.  17, No. 12, December 2006.
9. O’Neill M, et al. Long-term follow-up of persistent atrial fibrillation ablation using termination as a procedural endpoint. European Heart Journal. 2009.
10. Oral H, et al. A Randomized Assessment of the Incremental Role of Ablation of Complex Fractionated Atrial Electrograms After Antral Pulmonary Vein Isolation for Long-Standing Persistent Atrial Fibrillation. Journal of the American College of Cardiology. Vol. 53, No. 9, 2009.
11. Pappone C, et al. Atrial Electroanatomic Remodeling After Circumferential Radiofrequency Pulmonary Vein Ablation. Circulation: Journal of the American Heart Association. 104:2539-2544. 2001.
12. Marrouche N, et al. Phased-Array Intercardiac Echocardiography Monitoring During Pulmonary Vein Isolation in Patients with Atrial Fibrillation: Impact on Outcome and Compliactions. Circulation: Journal of  the American Heart Association. 107:2710-2716. 2003.
13. Pappone C, et all. Circumferential Radiofrequency Ablation of Pulmonary Vein Ostia: A New Anatomic Approach for Curing Atrial Fibrillation. Circulation: Journal of the American Heart Association. 102:2619-2628. 2000.
14. Haissaguerre M, etal. Changes in Atrial Fibrillation Cycle Length and Inducibility During Catheter Ablation and Their Relation to Outcome. Circulation: Journal of the American Heart Association. 109:3007-3013. 2004.
15. Scharf C, et al. Ablation of Persistent Atrial Finrillation Using Mulitelectrode Catheters and Duty-Cycled Radiofrequency Energy. Journal of the American College of Cardiology. Vol. 54, No. 15. 2009.
16. Wilber  D, et al. Comparison of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation in Patients with Paroxysmal Atrial Fibrillation: A Randomized Controlled Trial. Journal of the American Medical Association. 303:333-340. 2010.
17. Wazni  O, et al. Radiofrequency Ablation vs Antiarrhythmic Drugs as First-line Treatment of Symptomatic Atrial Fibrillation: A Randomized Trial. Journal of the American Medical Association. 293: 2634-2640. 2005.
18. Pritchett A, et al. Left Atrial Colume as Index of Left Atrial Size. Journal of the American College of Cardiology. 41:1036-1043. 2003.
19. Atrial Fibrillation Investigators. Arch Intern Med 1994;154:1449-1457.
20. Gersak B, et al. Importance of Evaluating Conduction Block in Radiofrequency Ablation for Atrial Fibrillation. European Journal of Cardio-thoracic Surgery. 2011.
21. Miyasaka Y, et al. Circulation. 2006; 114:119-25
22. Pritchett, JACC. 2003; 41:1036-43