balloon cryo-ablation for atrial fibrillation - his-files.comhis-files.com/pdf/acc/17_mon/hall...
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Aharon Medina, MD Department of Cardiology
Shaare Zedek Medical Center, Jerusalem, Israel
Balloon Cryo-Ablation For
Atrial Fibrillation
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Proctoring fee from Medtronic Israel
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Disclosures
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68-year-old male patient.
No structural heart disease.
Paroxysmal AF since 2005.
On Amiodarone and Warfarin since 2005.
Cardioverted in 2007 and 2010.
Presented with fatigue for a couple of months.
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A.I. case study
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Atrial Flutter
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Change / add medication?
Cardioversion?
Rate control?
Flutter ablation?
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What would you do?
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Patient underwent successful Isthmus Block on 16.01.2013 and returned to sinus rhythm during RF ablation.
Was discharged on Amiodarone and Warfarin because of the history of AF.
Two days later, he presented in the EW with palpitations and the following ECG:
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Follow up
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Atrial Fibrillation
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Change / add medication?
Cardioversion?
Rate control?
AF ablation?
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What would you do?
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The Strategies of Treatment of Atrial Fibrillation (STAF) study
J Am Coll Cardiol. 2003;41(10):1690-1696
• No differences between rhythm-control and rate-control strategies regarding primary endpoints .
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AFFIRM Study NEJM 2002, Circulation 2004
Age at enrollment <0.0001 1.06 1.04 1.08
Coronary artery disease <0.0001 1.65 1.31 2.07
Congestive heart failure <0.0001 1.83 1.45 2.32
Diabetes <0.0001 1.56 1.22 2.00
Stroke or TIA <0.0001 1.54 1.17 2.05
Smoking <0.0001 1.75 1.29 2.39
First episode of AFib 0.0067 1.27 1.01 1.58
Sinus rhythm <0.0001 0.54 0.42 0.70
Warfarin use <0.0001 0.47 0.36 0.61
Digoxin use <0.0001 1.50 1.18 1.89
Rhythm-control drug 0.0005 1.41 1.10 1.83
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• The presence of SR but not AAD use is associated with a lower risk of death.
• These results indicate that if an effective method for
maintaining SR with fewer adverse effects were available, it might improve survival.
AFFIRM study Circulation 2004
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Atrial Fibrillation Ablation
Ultimate Rhythm Control ?
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ACCF/AHA/HRS 2011 Guidelines Update Treatment of Atrial Fibrillation
Wann LS. J Am Coll Cardiol. 2011 Jan 11;57(2):223-42.2011.
Knight B. HRS Practical Rate and Rhythm Management of Atrial Fibrillation. Updated January 2010.
“In some patients, especially young individuals with very symptomatic AF, ablation may be preferred over years of drug therapy.”
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Focal Atrial Fibrillation - Concept
Single fast firing focus
initiates chaotic activation
of atria
Proximal pulmonary veins
focus location
Elimination or isolation of
pulmonary vein focus can
cure Afib.
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Microscopic Anatomy
of Pulmonary Veins
Myocardial sleeve
Saito T, et al. J Cardiovasc Electrophysiol (2000) 11: 888
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Pulmonary Vein Isolation is Currently the Most Common Ablation Technique Used for Atrial Fibrillation
Crandall M A et al. Mayo Clin Proc. 2009;84:643-662
© 2009 Mayo Foundation for Medical Education and Research
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“Ablation strategies which target the PVs and/or PV
antrum are the cornerstone for most AF ablation
procedures.”
Pulmonary Vein Isolation (PVI) is the Cornerstone of AF Ablation
Cappato et al., Circ Arrhythm Electrophysiol 2010;3;32-38 http://www.HRSonline.org/Policy/ClinicalGuidelines
2007 HRS Consensus Statement
Each vein should be isolated independently
Complete electrical isolation should be the goal for targeted PVs and entrance and/or exit block should be demonstrated
Left
Superior
Pulmonary
Vein
Left
Inferior
Pulmonary
Vein
Right Inferior
Pulmonary Vein
Right Superior
Pulmonary Vein
Superior
Vena
Cava
Inferior Vena Cava
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Anatomy of the Pulmonary Veins
Kato R, et al. Circulation (2003) 107: 2004
RIPV
RSPV
LSPV
LIPV
LA appendage
Right PV Left PV
• Nuclear magnetic resonance image of the ostia of the right and left superior and inferior PVs and the left atrial appendage 18
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• Patient anatomy and atrial tissue depth is variable
• Cardiac contractions make maintaining position difficult
• Catheter force varies with position in heart
• Technically challenging
• Good lesions require transmurality
• Successful procedure requires contiguous lesions
Challenges Using RF Focal Ablation Catheter to Isolate PV and Ablate Atrial Tissue
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Ablation Approach for Patients with Persistent Atrial Fibrillation
Crandall M A et al. Mayo Clin Proc. 2009;84:643-662
© 2009 Mayo Foundation for Medical Education and Research
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Advantages of Cryo energy
Minimal disruption of endothelium
Minimal thrombus production
Maintenance of extracellular matrix - no collagen
denaturation
No collagen shrinkage known to occur with thermal
injury
Advantageous within venous structures - CS or
PV’s
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Baloon Cryoablation
Hypothermic
Zone
Ablation Zone
(sub-zero)
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• Pressurized N2O delivered
through ultrafine injection
tube
• Straightforward positioning:
over-the-wire, steerable,
good visibility
• Several safety
mechanisms: double
balloon, pressure and flow
monitoring, blood detection
• Freezor® MAX operates on
similar principles
Arctic Front Catheter Balloon Segment
Inner Balloon
Outer Balloon
Guide Wire
Lumen Thermocouple
Injection
Tube Marker Band
Deflection Wires
Guide Wire
Arctic Front® Catheter Design
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Lesion outline from Arctic Front Catheter 23 mm ablation in swine LA-PV
junction (45-day survival). PV is cut open longitudinally and flattened out. Top of image: PV and its branches; Bottom: LA. TTC staining.
Pulmonary vein tissue, transition between collagen and muscular sleeve
Muscular pulmonary veins sleeve distal to the lesion
Contiguous lesion
performed by
Arctic Front®
Catheter
Towards the lungs
Towards the left atrium
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Circumferential Lesion at LA-PV Junction
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4. The CryoConsole controls safe delivery of N2O to the catheter and return of the vapor. Numerous safety systems mitigate potential hazards.
2. Inside the balloon the liquid N2O vaporizes and absorbs heat from the surrounding tissue.
3. The vapor is returned to the console through a lumen maintained under vacuum.
How the Arctic Front® Cardiac
Cryo-Ablation System Works?
1. Liquid N2O is delivered from the CryoConsole through an injection tube to the inner balloon.
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Arctic Front PV Isolation
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Achieve is an intracardiac
electrophysiology diagnostic
catheter which can be deployed
through the Arctic Front® guide
wire lumen.
Available in 15 mm and
20 mm loop diameters.
Both diameters are compatible
with 23 mm and 28 mm
Arctic Front.
Achieve™ Mapping Catheter
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1. Access
targeted vein
2. Inflate
and
position
3. Occlude and
ablate
4. Assess PVI
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How Arctic Front® Balloon Catheter and Achieve
TM Work?
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Pulmonary Vein Isolation
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Potential Complications
of AF Ablation
Pulmonary vein stenosis 5%
Atrio-esophageal fistula 0.5%
Phrenic nerve palsy 10%
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Pulmonary Vein Stenosis
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CT Analysis of the LA and Esophagus
Lemola K, et al. Circulation (2004) 110: 3655 37
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Phrenic Nerve Palsy
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Solutions ?
• Ablate within the Left Atrium
Not in the Pulmonary veins !
• Pace the Phrenic Nerve
• Monitor Esophageal Temperature
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Blanking period (90 day)
Inclusion Criteria:
• ≥ 2 documented AF Episodes in the prior 2 months
• Efficacy failure of ≥ 1 AAD (flecainide, propafenone, sotalol) Redo ablation n = 31 (19%)
* CRYO: Arctic Front® System
26 centers in US and Canada
AAD optimization
Drug Crossover n = 65 (79%)
Cryoballoon ablation (CRYO)
n = 163
AAD Rx (DRUG)
n = 82
Follow-up at 1, 3, 6, 9 & 12 Months
N = 245 Randomized 2:1 to CRYO* or DRUG
STOP AF Trial Sustained Treatment of Paroxysmal Atrial Fibrillation
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0 100 200 300 400 500
Days
0%
20%
40%
60%
80%
100%
Tre
atm
en
t S
uccess
STOP AF Trial - Results
Cryo 69.9% (114/163)
Drugs 7.3% (6/82)
p < 0.001
Blanked
for
Detectable
AF
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42 42 (self reported)
0%
20%
40%
60%
80%
100%
AFEpisodes
Palpitations Fatigue Rapid heartbeat
Dyspnea Dizziness Syncope
100%
86%
76%
66%
54% 48%
4%
20% 25%
14% 18%
11% 7%
1%
20% 25%
13% 16%
9% 9%
1%
Baseline 6 Mo 12 Mo
% Subjects
AF Symptoms at 12M: CRYO Subjects
Baseline 6 Months 12 Months
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Single-arm, non-randomized study (followed STOP AF)
80 subjects in 12 centers
Follow-up at 1,3,6,12 months and 2,3,4,5 years post-cryoablation
procedure
Purpose to continue evaluating
Safety and efficacy of Arctic Front® system
The impact of experience on the learning curve
The chronic success rate of Cryoballoon ablation
increased with experience
US Continued Access Protocol (CAP)
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Phrenic nerve injury risk decreased from
11.2% in STOP AF to 4.8% in CAP AF
Pulmonary vein stenosis decreased from
3.1% to 1.3%
One patient had a second ablation procedure
using RF. At this time, the root cause of the
PV stenosis is under review.
CAP AF Safety Summary
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• PV isolation was achieved without touch-up in 91.1% of patients, using the smaller balloon in 26.7%, the larger balloon in 25.6%, and both balloons in 47.7% of patients.
• Long-term follow-up data >12 months (median 30 months; interquartile range 18 to 48 months) were available for 451 patients.
• 278 patients (61.6%) were free of AF recurrence with no need for repeat procedures after the 3-month blanking period. Rates of freedom from AF after 1, 2, and 3 repeat procedures were 74.9%, 76.2%, and 76.9%, respectively.
• Use of the smaller balloons or both balloons produced the highest rates of long-term freedom from AF. Phrenic nerve palsy occurred in 12 patients (2%), resolving within 3 to 9 months.
Long Term Follow up – Vogt at al JACC December 2012
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Long Term Follow up – Vogt at al JACC 2012
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In a prospective European single-center study, 163
patients underwent PVI with a cryo-balloon. Five years
success rate after a single ablation procedure was
53%.
Up to 11% of the patient experienced phrenic nerve
palsy, all reversible within 9 months.
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Long Term Follow up – Neumann at al
Europace 2013
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He underwent successful Isolation of 4 PV’s on 13.03.2013
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Back to our patient…
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• Cardiac CT and Trans-Esophageal Echocardiography were performed the day before the procedure.
• Cardiac CT images underwent segmentation using the Ensite Velocity system (St. Jude Medical) to obtain a 3-D picture of the LA and assess the PVs diameters.
• A single trans-septal puncture was performed and a deflectable sheath (FlexCath, Medtronic) was advanced into the LA.
• A 28 mm only Cryo-balloon (Arctic Front, Medtronic) was advanced over a 20 mm lasso catheter (Achieve, Medtronic) placed through its central lumen.
• Rt. phrenic nerve stimulation was performed during ablation of the right PVs.
• The esophageal temperature was monitored during ablation.
Shaare Zedek Ablation Protocol
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CT Image of Pulmonary Veins
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Cryo-Ablation of LSPV
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Cryo-Ablation of LIPV
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Cryo-Ablation of RIPV
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Cryo-Ablation of RSPV
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Cryo-Ablation of RIPV – Big Loop
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Pulmonary Vein Isolation
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• Between July 2012 & May 2013, cryo-ablation was performed in 18
patients (age 56 [22-68]) for whom at least one AAD has failed: 12
with paroxysmal AF, 5 with persistent AF and 1 with left atrial
tachycardia.
• 66 of 70 PV’s (94.3%) were successfully isolated. The right inferior
PV was not isolated in 4 patients: 1 - not attempted, 1 - technical
issue, 2 - unsuccessful.
• Radiation time was 70 ± 32 min (dropping with learning curve).
• After the 3 months blanking period, sinus rhythm was maintained in
80% of patients, follow up averaging 193 days (range 72-325).
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Shaare Zedek Experience
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Complications:
Phrenic nerve palsy occurred in 1 patient (5.6%)
and lasted for 30 minutes.
Two patients had a minor pericardial effusion.
No PV stenosis or esophageal fistula.
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Shaare Zedek Experience
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Cryoablation with the Arctic Front System:
• Effectively treats drug refractory PAF or early persistent AF.
• Is a safe and efficient procedure.
• Has shorter procedure times compared to RF ablation according to large published trials.
• Further follow up is needed to assess the long-term success rate.
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Conclusions
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So far in Sinus Rhythm… (3 months and 4 days)
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Our Patient?