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ATRIAL FIBRILLATION CONTINUUM OF CARE.  Accounts for 1/3 of hospital admissions for cardiac rhythm disturbances  Highly symptomatic and affects quality.

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Presentation on theme: "ATRIAL FIBRILLATION CONTINUUM OF CARE.  Accounts for 1/3 of hospital admissions for cardiac rhythm disturbances  Highly symptomatic and affects quality."— Presentation transcript:

1 ATRIAL FIBRILLATION CONTINUUM OF CARE

2  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 AFOver 100,000 strokes in the US alone attributable to AF  Increasing prevalence due to aging population THERMOCOOL ® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO ® Systems (excluding NAVISTAR ® RMT THERMOCOOL ® Catheter) 1 Friberg L, Hammar N, Rosenqvist M (2010) Stroke in paroxysmal atrial fibrillation: report from the Stockholm Cohort of Atrial Fibrillation. Eur Heart J 31 (8): Fuster V, 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): 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): Gersh B, Tsang T, Bames M, Seward J (2005). The changing epidemiology of non-valvular atrial fibrillation: the role of novel risk factorsGersh B, Tsang T, Bames M, Seward J (2005). Eur Heart J. Supplements 7: C5-C11. AF WILL HAVE AN INCREASING IMPACT ON HEALTHCARE

3 AF AFFECTS ATRIAL MECHANICAL FUNCTION Atrial fibrillation (AF) is characterized by uncoordinated atrial activation with consequent deterioration of atrial mechanical function THERMOCOOL ® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO ® Systems (excluding NAVISTAR ® RMT THERMOCOOL ® Catheter) 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 Normal Heart Function and AF Source: Adapted from the Mayo Clinic (website). Comparison of Normal Heart Function and Atrial Fibrillation. Updated August 18, (http://www.mayoclinic.org/atrial- fibrillation/enlargeimage837.html). Accessed December 10, 2010.

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

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 THERMOCOOL ® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO ® Systems (excluding NAVISTAR ® RMT THERMOCOOL ® Catheter) Heart Rhythm Vol. 4, No 6, June 2007 ACC/AHA/ESC Classification of AF

6 AF TREATMENT GUIDELINES THERMOCOOL ® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO ® Systems (excluding NAVISTAR ® RMT THERMOCOOL ® Catheter) * 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 Disabling symptoms in AF Anticoagulation & rate control as needed AADs & cardioversion as needed Catheter ablation* if AAD treatment fails (Paroxysmal AF is the only FDA approved Indication for catheter ablation) 2007 US Population (301M) Minimal or no symptoms Anticoagulation & rate control as needed Permanent AF (longstanding persistent AF) Anticoagulation & rate control as needed Recurrent paroxysmal or persistent AF AF Prevalence (3.1M)

7 RHYTHM CONTROL IS NOT INFERIOR TO RATE CONTROL Rate control: Rate control: minimize symptoms and reduce heart rate Rhythm control : 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 THERMOCOOL ® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO ® Systems (excluding NAVISTAR ® RMT THERMOCOOL ® Catheter) 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): Rate vs Rhythm Control

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

9 AF IS A PROGRESSIVE DISEASE  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) THERMOCOOL ® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO ® Systems (excluding NAVISTAR ® RMT THERMOCOOL ® Catheter) 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 Progression of AF

10 THE LONGER THE AF DURATION THE MORE DIFFICULT TO RESTORE SINUS RHYTHM 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) Rates of Transition to Persistent or Chronic AF: % Patients by Type of AF at Baseline

11 AF SIGNIFICANTLY AFFECTS QUALITY OF LIFE THERMOCOOL ® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO ® Systems (excluding NAVISTAR ® RMT THERMOCOOL ® Catheter) 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 SF-36 Quality of Life of Patients with AF Compared with the General Population and Patients with Other Cardiovascular Conditions

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

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

14 META-ANALYSES DEMONSTRATE THAT RF ABLATION IS MORE EFFECTIVE THAN ADT FOR MANAGING AF IN CERTAIN PATIENTS THERMOCOOL ® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO ® Systems (excluding NAVISTAR ® RMT THERMOCOOL ® Catheter) 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

15 RF ABLATION IMPROVES QUALITY OF LIFE THERMOCOOL ® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO ® Systems (excluding NAVISTAR ® RMT THERMOCOOL ® Catheter) 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 QoL Assessment: Absolute Change from Baseline to Three Months

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 THERMOCOOL ® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO ® Systems (excluding NAVISTAR ® RMT THERMOCOOL ® Catheter) Objectives differ patient to patient, but our approach matters every time

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 THERMOCOOL ® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO ® Systems (excluding NAVISTAR ® RMT THERMOCOOL ® Catheter) Map Creation Video Map Creation Video Map Creation Video Map Creation Video Ablation Video Ablation Video Ablation Video Ablation Video

18 RF ABLATION INVOLVES LESION CREATION TO PREVENT ABNORMAL ACTIVATION 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): THERMOCOOL ® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO ® Systems (excluding NAVISTAR ® RMT THERMOCOOL ® Catheter)  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

19 CASE STUDIES CASE STUDIES #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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