Christopher L. Fellows, MD, FACC, FHRS

Virginia Mason Medical Center

Seattle, Wa.

Cardiac Arrhythmias 2015

NEI CHING SU WENThe Yellow Emperor's Classic Textbook of Internal Medicine

“When the pulse is irregular and tremulous and the beats occur at intervals, then the impulse of life fades”

Huang TiCirca 2696-2598 BC

Hering HE. Das Elektrocardiogramm des Irregularis perpetuus. Deutsches Archiv fur Klinische Medizin. 1908; 94:205-8.

1)1) 2014 AHA/ACC/HRS Guidelines for the 2014 AHA/ACC/HRS Guidelines for the Management of AFManagement of AF

2)2) 2011 Focused Update on the management of 2011 Focused Update on the management of AFAF

3)3) 2012 Expert Consensus Statement on 2012 Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Catheter and Surgical Ablation of Atrial FibrillationFibrillation

www.acc.org www.hrsonline.org

National Coverage Determination (NCD).

The following indications are covered: 1. Documented non-reversible symptomatic bradycardia due to sinus node dysfunction.2. Documented non-reversible symptomatic bradycardia due to second degree and/or third degree atrioventricular block.

8/13/2013

Basic Arrhythmology

Take a good historyDocument the arrhythmiaSymptom/rhythm correlationEvaluate for structural heart diseasePrecipitating factors (T4, Electrolytes,

ETOH)

Why treat ?

Symptoms (palps to syncope)Prevent Cardiac ArrestPrevent stroke (AF)Prevent worsening of Arrhythmogenic

substratePrevent Arrhythmia induced myopathy

Rate related cardiomyopathy

Tachy-cardiomyopathy

1913 Gossage and Braxton Hicks described a case of AF in a young man who developed CHF …. “which might very well have been a consequence not a cause of the auricular fibrillation”

Gossage AM, Braxton Hicks JA Q J Med 1913;6:435-40.

“auricular fibrillation, apart from any other disease of the heart, may cause severe congestive failure and that upon cessation of the arrhythmia the congestive failure may be followed by complete and lasting recovery”

I. C. Brill, 1937

What tools do we have ?

DrugsPacersICDsAblation

What tools do we have ?

DrugsPacersICDsAblation

AF is very frustrating

Causes strokes…strokes are BADMakes pts feel BADTherapy toxic and ineffective

Is Sinus Rhythm Important ?

AFFIRM (Wyse DG, et.al. NEJM 2002;347:1825-31)

RACE (Hagens VE, et.al. JACC 2004;43:241-247.)

STAF (Carlsson J, et.al. JACC 2003;41:1690-1696.)

All concluded …..that there were no mortality differences between rate control and rhythm control strategies in the treatment of AF

Sinus Rhythm

AFFIRM type trials excluded highly symptomatic patients

Trials designed to test strategy not therapyTherapy was very ineffective

AFFIRM Substudy

On treatment analysisNSR= 47% lower risk of deathAAD use = 49% increased risk of death

AFFIRM investigators. Circ 2004;109:1509-1413

“…the failure of AFFIRM, RACE, or STAF in showing any differences between rate and rhythm control is not so much a positive statement for rate control but rather a testimony on the ineffectiveness of the rhythm control methods used.”

Verma A, Natale A. Circulation 2005;112:1214-1231.

OK, Sinus rhythm is good but at what price ?

DrugsPacerICDAblation

OK, Sinus rhythm is good but at what price ?

DrugsPacerICDAblation

“… the success of Pulmonary Vein Antral Isolation can exceed 90%, sometimes requiring 2 procedures, and there is an associated risk of stroke <1%, cardiac perforation <1%, pulmonary vein stenosis <1%, vascular injury <1%, and atrioesophageal fistula 1/1000.”

Results

Worldwide data* (100 centers), 52% efficacy (27% repeats) 6%

complicationsUS data** (92 centers)

66% efficacy

*Cappato R, Calkins H, Chen S et.al Circ. 2005;111:1100-1105.

**Mickelson S, Dudley B, Treat E, et.al. JICE 2005;12:213-220.

Published Catheter Ablation Success Rates

Success Rates Catheter Ablation

Calkins H, et al. Circulation. 2009;2:349-361.

N = 63 studies 6936 pts

Major complications 4.9%

Recent RF study

SMART-AF prospective trial (N=161)Contact force catheterVery experienced operators72.5% 12 month freedom from AF

compared to 66% (open irrigated)4 perforation/tamponade (2.48%)

Natale A, et.al, JACC 2014;64:647-56.

Cryoablation

1948 (Hass) surgical Cryo lesions in Cardiac surgery using CO2

1963 (Cooper) developed liquid nitrogen surgical cryo tools

1977 (Gallagher) reported AVN ablation using surgical cryoablation

1991 (Gillette) cryoablation catheter in animals

1999 (Dubuc) cryocatheter in humans

Cryoballoon results 2/11 – 10/14(CF)N=595 (male 72%)Ages 29-84All symptomatic, documented multiple

AF episodes, failed drug therapy.82/595 prior failed procedures (8

surgical Maze, 10 multiple RF failures)

Cryoballoon results 2/11 - 12/13

124 patients >1 yr f/u 90% NSR, (77% 95/124 NSR off drugs).

Advance Balloon f/u > 12 mo

50 pts ablated between 6/12 and 11/1247/50 f/u data available39/47 cured (no AF no AAD) (83%)4/47 brief AF no AAD2/47 no AF remain on AAD2/47 failures (4%)

96 %

Advance Balloon f/u > 12 mo PAF only62 pts f/u between 6/14 and 8/1412 month survey data available on all51/62 cured (no AF no AAD) (82%)7/62 better (brief symptoms no AAD or

no symptoms w/ AAD (11%)4/62 failures (7%)

93 %

Immediate Lab Complications (18/595 = 3%)7 groin hematoma (1.1%) (no intervention

required)2 hypotension/acidosis 1 hyperkalemia1 phenylepherine IV extravasation2 hematuria from foley placement1 ileus 1 temporary pacing overnight for

bradycardia1 cath/stent2 CHF exacerbation

Phrenic nerve palsy (N=595)44 Phrenic nerve palsy (7.4%)40 transient with full recovery in lab. 4 persistent at discharge, 3 with full

recovery by 3 months, 1 recovery in 12 months.

Late Complications (N=595)

0 CVA ,TIA,MI, or embolism0 Tamponade0 EA fistula0 Deaths0 persistent phrenic nerve palsy (1 yr)

“… the success of Pulmonary Vein Antral Isolation can exceed 90%, sometimes requiring 2 procedures, and there is an associated risk of stroke <1%, cardiac perforation <1%, pulmonary vein stenosis <1%, vascular injury <1%, and atrioesophageal fistula 1/1000.”

Repeat Procedures

25 %-33% with RF30/595 (5.0%) with Cryo

GoalsImprove efficacyDecrease complicationsDecrease repeat proceduresMinimize iatrogenic arrhythmias ( LA

flutter)Decrease lab time or minimize

variability

Total Lab Time

Long-term Outcomes

N= 605 (579 PAF)18-48 month f/u ( median 30 month)61.6% single procedure74.9% multiple procedurePNP 2% ( last 420 patients 0.7%)

Vogt J, et al. JACC 2013;61:1707-12

AF AblationThe “Cure”….where are we ?

The concepts are goodThe tools are getting betterCurrent techniques are becoming more

practical for widespread applicationSafety remains a concern

AF ablation remains a second line therapy for highly symptomatic patients who fail medical management or cannot /will not take medications (2006)

or first line therapy for selected patients (2011)

Things to consider

This is great for symptomatic paroxysmal AF

It is a 2 hour procedure under a general anesthetic

Requires anticoagulation with warfarinIt does not change your CHADS scoreIt doesn’t work in everybodyThere are serious potential

complications