atrial fibrillation continuum of care. accounts for 1/3 of hospital admissions for cardiac rhythm...

ATRIAL FIBRILLATION CONTINUUM OF CARE

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

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):967-975.2 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):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 factorsGersh B, Tsang T, Bames M, Seward J (2005). Eur Heart J. Supplements 7: C5-C11.

AF WILL HAVE AN INCREASING IMPACT ON HEALTHCARE

AF AFFECTS ATRIAL MECHANICAL FUNCTION

Atrial fibrillation (AF) is characterized by uncoordinated atrial activation with consequent deterioration of atrial mechanical function


Heart Rhythm Vol. 4, No 6, June 2007Atrial 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

Normal Heart Function and AF

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.

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

SOURCE: Jalife J, Berenfeld O, Mansour M (2002) Mother rotors and fibrillatory conduction: a mechanism of atrial fibrillation. Cardiovasc Res 54 (2):204-216.

Structure and Mechanism of AF

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


Heart Rhythm Vol. 4, No 6, June 2007

ACC/AHA/ESC Classification of AF

AF TREATMENT GUIDELINES


* 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


Permanent AF (longstanding persistent AF)


Recurrent paroxysmal or persistent AF

AF Prevalence (3.1M)

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


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.

Rate vs Rhythm Control

THE BIGGER PICTURE


Sinus Rhythm via ablation:Most atrial fibrillation will not progressRisk of side effects dissipate

Rate Control:Atrial fibrillation tends to continue to progressDrug failure rates and side effects increase with time

Survival is crucialAdditional important factors:Effectiveness of the treatmentQuality of life for the patient

WHEN CONSIDERING RATE VS RHYTHM CONTROL, MANY FACTORS NEED TO BE CONSIDERED

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)


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

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


Rates of Transition to Persistent or Chronic AF: % Patients by Type of AF at Baseline

AF SIGNIFICANTLY AFFECTS QUALITY OF LIFE


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

ADT IS ASSOCIATED WITH ADVERSE EVENTS


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


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)

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

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

QoL Assessment: Absolute Change from Baseline to Three Months

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

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

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):335-379.


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

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)


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


VIDEO FOR “THE ABLATION PROCEDURE” CREATING THE MAP Return

VIDEO FOR “THE ABLATION PROCEDURE” AF ABLATION Return

atrial fibrillation continuum of care. accounts for 1/3 of hospital admissions for cardiac rhythm...

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