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ATRIAL FIBRILLATION CONTINUUM OF CARE

ATRIAL FIBRILLATION CONTINUUM OF CARE. AF WILL HAVE AN INCREASING IMPACT ON HEALTHCARE. Accounts for 1/3 of hospital admissions for cardiac rhythm disturbances Highly symptomatic and affects quality of life Accounts for 15% of all stroke in US

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ATRIAL FIBRILLATION CONTINUUM OF CARE

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  1. ATRIAL FIBRILLATION CONTINUUM OF CARE

  2. AF WILL HAVE AN INCREASING IMPACT ON HEALTHCARE • Accounts for 1/3 of hospital admissions for cardiac rhythm disturbances • Highly symptomatic and affects quality of life • Accounts for 15% of all stroke in US • Over 100,000 strokes in the US alone attributable to AF • Increasing prevalence due to aging population 1 FribergL, Hammar N, Rosenqvist M (2010) Stroke in paroxysmal atrial fibrillation: report from the Stockholm Cohort of Atrial Fibrillation. Eur Heart J 31 (8):967-975. 2FusterV, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S (2006) ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation-executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of 3 Patients with Atrial Fibrillation). Eur Heart J 27 (16):1979-2030. Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE (2001) Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 285 (18):2370-2375. 4Gersh B, Tsang T, Bames M, Seward J (2005). The changing epidemiology of non-valvular atrial fibrillation: the role of novel risk factorsGershB, Tsang T, Bames M, Seward J (2005). EurHeart J. Supplements 7: C5-C11. THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  3. AF AFFECTS ATRIAL MECHANICAL FUNCTION Normal Heart Function and AF Atrial fibrillation (AF) is characterized by uncoordinated atrial activation with consequent deterioration of atrial mechanical function Heart Rhythm Vol. 4, No 6, June 2007 Atrial fibrillation. (2009, July 30). In Wikipedia, The Free Encyclopedia. Retrieved 20:50, July 30, 2009, from http://en.wikipedia.org/w/index.php?title=Atrial_fibrillation&oldid=305148284 Source: Adapted from the Mayo Clinic (website). Comparison of Normal Heart Function and Atrial Fibrillation. Updated August 18, 2010. (http://www.mayoclinic.org/atrial-fibrillation/enlargeimage837.html). Accessed December 10, 2010. THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  4. VARIOUS MECHANISMS CONTRIBUTE TO AF • Evidence suggests that AF can be attributed to three mechanisms: • Multiple, random propagating wavelets • Focal electrical discharges • Localized reentrant activity with fibrillatory conduction Structure and Mechanism of AF SOURCE: JalifeJ, Berenfeld O, Mansour M (2002) Mother rotors and fibrillatory conduction: a mechanism of atrial fibrillation. Cardiovasc Res 54 (2):204-216. THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  5. AF IS CLASSIFIED INTO SUB-TYPES • Paroxysmal:recurrent AF (≥2 episodes), that terminates spontaneously within 7days • Persistent:AF sustains >7 days, or lasts less than 7 days but necessitates pharmacologic or electrical cardioversion • Longstanding persistent (permanent):continuous AF of greater than 1 year duration ACC/AHA/ESC Classification of AF Heart Rhythm Vol. 4, No 6, June 2007 THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  6. AF TREATMENT GUIDELINES 2007 US Population (301M) AF Prevalence (3.1M) Recurrent paroxysmal or persistent AF Permanent AF (longstanding persistent AF) Minimal or no symptoms Disabling symptoms in AF Anticoagulation & rate control as needed Anticoagulation & rate control as needed Anticoagulation & rate control as needed AADs & cardioversionas needed Catheter ablation* if AAD treatment fails (Paroxysmal AF is the only FDA approved Indication for catheter ablation) * There is currently no FDA approved catheter for ablation of persistent AF ACC/AHA/ESC Guidelines for Management of pts with AF; Circulation 2006;114:257–354 THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  7. RHYTHM CONTROL IS NOT INFERIOR TO RATE CONTROL • Rate control: minimize symptoms and reduce heart rate • Rhythm control: restore and/or maintain sinus rhythm • Randomized controlled trials have compared the efficacy of rate versus rhythm control treatments for the management of AF • No significant differences in mortality, thromboembolism or bleeding, cardiovascular events, or symptomatic improvement. • Findings suggest rhythm control is not inferior to rate control Rate vs Rhythm Control Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD (2002) A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med 347 (23):1825-1833. THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  8. WHEN CONSIDERING RATE VS RHYTHM CONTROL, MANY FACTORS NEED TO BE CONSIDERED THE BIGGER PICTURE • Survivalis crucial • Additional important factors: • Effectivenessof the treatment • Quality of life for the patient Rate Control: Atrial fibrillation tends to continue to progress Drug failure rates and side effects increase with time Sinus Rhythm via ablation: Most atrial fibrillation will not progress Risk of side effects dissipate THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  9. AF IS A PROGRESSIVE DISEASE Progression of AF • HATCH Score: • Estimates the probability of AF progression in patients with paroxysmal AF • The HATCH score contains four categories: • Very low (0) • Low (1) • Moderate (2 to 4) • High (5 to 7) Progression to persistent AF occurred in approximately 50% of patients with a HATCH score > 5 and in 6% of patients with a HATCH score of zero THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  10. THE LONGER THE AF DURATION THE MORE DIFFICULT TO RESTORE SINUS RHYTHM Rates of Transition to Persistent or Chronic AF: % Patients by Type of AF at Baseline Rates of progression from paroxysmal AF to more frequent and intractable forms of AF ranged up to 30% at 5 years, with annual risk estimates generally 3-6% over time THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  11. AF SIGNIFICANTLY AFFECTS QUALITY OF LIFE SF-36 Quality of Life of Patients with AF Compared with the General Population and Patients with Other Cardiovascular Conditions • The SF-36 is a Quality of Life measurement which assesses eight concepts: • General health perception • Physical functioning • Social functioning, • Role limitations due to physical problems • Bodily pain • Mental health • Role limitations due to emotional problems • Vitality • AF patients have significantly reduced quality of life as compared to the general population and patients with other cardiovascular conditions THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  12. ADT IS ASSOCIATED WITH ADVERSE EVENTS Commonly Prescribed AADs: Potential Adverse Events and Contraindications The high incidence of adverse events and recurrence rates may outweigh expected quality of life improvements from antiarrhythmic drugs THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  13. ADT HAS A HIGH RATE OF AF RECURRENCE COMPARED WITH CATHETER ABLATION The recurrence rate of patients treated with antiarrhythmic drugs is higher than with RF ablation Kaplan-Meier Curve of Time to Recurrence of Symptomatic Atrial Arrhythmia Following Second Line Antiarrhythmic Drug Therapy (ADT) THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  14. META-ANALYSES DEMONSTRATE THAT RF ABLATION IS MORE EFFECTIVE THAN ADT FOR MANAGING AF IN CERTAIN PATIENTS The studies reported that approximately 77% of RFCA treated patients remained free of AF recurrence in comparison to only 19% to 52% of ADT treated patients Meta-Analyses Comparing Catheter Ablation to ADT in Patients with AF THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  15. RF ABLATION IMPROVES QUALITY OF LIFE A prospective, multicenter, randomized clinical trial compared RFCA and ADT in 167 patients with paroxysmal AF Patients in the RFCA group displayed improvements in QoL compared with ADT patients at 3 months, and without significant change at 6 and 9 months QoLAssessment: Absolute Change from Baseline to Three Months THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  16. COMPLETE SOLUTION FOR PATIENTS • Develop treatment pathway guidelines as a team • Treat atrial fibrillation to focus on potential other heart problems • Determine a plan for drug refractory patients Objectives differ patient to patient, but our approach matters every time THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  17. THE ABLATION PROCEDURE A minimally invasive technique in which radiofrequency (RF) energy is used to neutralize small areas of the heart tissue that generate and conduct abnormal electrical activity, the source of the arrhythmia Map Creation Video Ablation Video THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  18. RF ABLATION INVOLVES LESION CREATION TO PREVENT ABNORMAL ACTIVATION • RF ablation uses high frequency alternating current to eliminate or alter the arrhythmogenic substrate • An ablation catheter is used to apply RF to the endocardium to produce continuous lesions (scars) that prevent the abnormal electrical activation contributing to AF • The most common lesion sets include circling of the pulmonary veins (PVs) called circumferential PV isolation Source: Adapted from Calkins H, Brugada J, Packer DL et al. (2007) HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. A report of the HRS Task Force on Catheter and Surgical Ablation of Atrial Fibrillation developed in partnership with the EHRA and the ECAS; in collaboration with ACC, AHA, and the STS. Endorsed and approved by the governing bodies of the ACC, AHA, ECAS, EHRA, STS, and the HRS. Europace 9(6):335-379. THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  19. CASE STUDIES CASESTUDIES #1 Patient characteristics: Age, gender, duration of AF, left atrial size, comorbidities, pharmacological history Ablation procedure utilized: linear, focal, isolation, circumferential, CFAE, combined, etc. Patient Outcomes: AF free, time to AF recurrence, other atrial arrhythmias, quality of life, post-procedure AAD therapy, rhythm control, and stroke risk control Complications: adverse events (PV stenosis, stroke, fistula, other arrhythmias, tamponade, second ablation) THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  20. CONCLUSION AF is a progressive disease. The longer the duration of the disease the more difficult it is to restore / maintain sinus rhythm RF catheter ablation for paroxysmal AF has been demonstrated to be safe and effective for patients that are refractory or intolerant to antiarrhythmic drugs RF ablation has been demonstrated to have a less AF recurrences and improves quality of life as compared to antiarrhythmic drugs Referring patients for early intervention, will reduce patient management complexity THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter)

  21. VIDEO FOR “THE ABLATION PROCEDURE” CREATING THE MAP Return

  22. VIDEO FOR “THE ABLATION PROCEDURE” AF ABLATION Return

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