new advances in atrial fibrillation ablation: cryoballoon-based pulmonary vein isolation
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New Advances in Atrial Fibrillation Ablation: Cryoballoon-Based Pulmonary Vein
Isolation
Ahmed F. Osman, MD, FACC FESC, FHRS, FASE
Florida Heart Rhythm Specialists, PLLCDirector, Cardiac EP lab, Broward General
Medical CenterNOVA Southeastern University
22
Atrial Fibrillation Health Risks and Costs
• Negative impact on quality of life1,2
• Leading cause of stroke: 5x increased risk3
• Increases risk of heart failure4
• Increases US healthcare system costs: $12 billion estimated cost to treat AF5
1. Singh SN, et al. J Am Coll Cardiol. 2006;48:721-730.2. Kang Y. Heart Lung. 2006;35:170-177.3. Wolf PA, et al. Stroke. 1991;22:983-988.4. White PD: Heart disease. New York, NY, The McMillan Co, 1937.5. Kim M, et al. Adv.Ther. 2009;26:847-857.
Thoracic vein and atrial pathogenesis of AFExtension of
muscular fibers into pulmonary
vein (PV)Ganglia noted
in yellow
Large and small reentrant
wavelets that play a role in initiating andsustaining AF
Common locations of PV
(purple) and common sites
of origin of non-PV
triggers (black)
Composite of anatomic and
arrhythmic mechanisms
of AF
Calkins et al. Heart Rhythm. 2007;4:1-46.
LSPV
LIPV
RSPV
IVC
RIPV
SVC
LSPV
LIPV
RSPV
IVC
SVC
LSPV
LIPV
RSPV
IVC
RIPV
SVC
LSPV
LIPV
RSPV
IVC
RIPV
SVC
RIPV
Indications for Catheter AF Ablation
• Symptomatic AF refractory or intolerant to at least one Class I or III antiarrhythmic medication
• In rare clinical situations, it may be appropriate as first-line therapy
• Selected symptomatic patients with heart failure and/or reduced ejection fraction
• Presence of a left atrial thrombus is contraindication to catheter ablation of AF
“It's far more important to know what person the disease has than what disease the person has.”
Hippocrates
Patient Selection for AblationMore Optimal Patient Less Optimal Patient
Variable
Symptoms Highly symptomatic Minimally symptomatic
Class I and III drugs failed 1 0
AF type Paroxysmal Long-standing persistant
Age Younger (<70 years) Older (70 years)
LA size Smaller (<5.0 cm) Larger (5.0 cm)
Ejection fraction Normal Reduced
Congestive heart failure No Yes
Other cardiac disease No Yes
Pulmonary disease No Yes
Sleep apnea No Yes
Obesity No Yes
Prior stroke/TIA No YesCourtesy of Hugh Calkins, MD.
66
Pulmonary Vein Isolation (PVI) is the Cornerstone of AF Ablation
“Ablation strategies which target the PVs and/or PV antrum are the cornerstone for most AF ablation procedures.”
Cappato et al., Circ Arrhythm Electrophysiol 2010;3;32-38 http://www.HRSonline.org/Policy/ClinicalGuidelines
Isolate each PV independently
2007 HRS Consensus Statement
Complete electrical isolation should be the goal for targeted PVs and entrance and/or exit block should be demonstratedLeft
Superior Pulmonary
Vein
LeftInferior
Pulmonary Vein
Right Inferior Pulmonary Vein
Right Superior Pulmonary Vein
Superior Vena Cava
Inferior Vena Cava
Controlled Trials of AF Ablation Patients Free of AF (% at 1 Year)
Courtesy of Jeremy N. Ruskin, MD, Massachusetts General Hospital.
Perc
ent
88
Challenges Using RF Focal Ablation Catheter to Isolate PV and Ablate Atrial Tissue
• 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
99
• Risk of perforation• Uncontrolled energy delivery • Esophageal damage• Char/coagulum formation• Inconsistent results• Time consuming point-by-point
ablation• 6% complication rate• 3- to 6-hour procedure times• Success rates:
– 14.5% - 76.5% w/o AAD– 8.8% - 50.3% w/AAD
Clinical Issues with Conventional RF Focal Ablation Catheter
Cappato R, et al. Circulation. 2005;111:1100-1105.
1010
Clinical Issues with Conventional RF Focal Ablation Catheter
• 6% complication rate• 3- to 6-hour procedure times• Success rates:
– 14.5% - 76.5% w/o AAD– 8.8% - 50.3% w/AAD
Cappato R, et al. Circulation. 2005;111:1100-1105.
Arctic Front® Catheter Design
• 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
Arctic Front Catheter Balloon Segment
Inner Balloon
Outer Balloon
Guide Wire Lumen Thermocouple
Injection Tube
Marker Band
Deflection Wires
Guide Wire
1212
Hypothermia
• Ice formation and thawing
• Apoptosis• Necrosis
Cryoablation Effects Include Multiple Mechanisms
Baust, Institute of Biomedical Technology, SUNY 2002
1313
Histological Effect on the Connective Tissue Matrix
• Cryoadhesion improves contact and stability, minimizing the amount of fluoro used
• Preserves the extracellular matrix and endothelial integrity1
• Decreases risk of thrombus formation1
• Demonstrates well demarcated lesions1
1 Sarabanda AV, et al. J Am Coll Cardiol. 2005;46:1902-1912.
1414
Properties of Cryoablation
• Removes heat from the tissue• Leads with a wave of hypothermia• Ablates at the point of balloon contact
Hypothermic Zone
Ablation Zone (sub-zero)
1515
Achieve™ Mapping Catheter
• 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
• Either diameter compatible with 23 mm and 28 mm Arctic Front
16
How Arctic Front® Balloon Catheter and AchieveTM Work
1. Accesstargeted vein
2. Inflate and position
3. Occlude and ablate
4. Assess PVI
16
17
Standardized ProcedureDoes Not Require Complex 3D Mapping
Arctic Front® Cryoballoon
Fluoroscopy image during contrast dye injection shows full occlusion of the left superior pulmonary vein.
• Arctic Front creates circumferential lesions,1 using 2-3 applications per vein to achieve PVI2
• Does not require 3D mapping• Achieve Mapping Catheter can be
deployed through the Arctic Front guide wire lumen, minimizing catheter exchanges
• Allows the procedure to be performed using a single transseptal puncture
Achieve™ Mapping Catheter
Image: Courtesy of Dr. Vogt, Herz- und Diabeteszentrum NRW, Germany1 Sarabanda AV, et al. EffJ Am Coll Cardiol. 2005;46:1902-1912.2 Medtronic, Inc. Arctic Front Cardiac CryoAblation Catheter clinical reports, in support of FDA premarket approval. 1
7
Entire procedure can be done using fluoroscopy or intracardiac echocardiography
18
Assessment of Real-Time PV Isolation• Achieve™ mapping catheter allows
for real-time assessment of PV isolation during cryoablation with Arctic Front®
Images: Courtesy of Dr. Schwagten, ZNA Middelheim, Belgium (above) and Dr. Vogt, Herz- und Diabeteszentrum NRW, Germany (right)
Delay Increased Delay
Isolation Arctic Front is positioned against the LIPV ostium, with Achieve positioned to assess PV isolation
18
19
2020
European Clinical Study ResultsSymptomatic Drug Refractory PAF Efficacy Results
Efficacy Neumann Van Belle Kojodjojo
PVI 97% Arctic Front® 98.5% Arctic Front 83% Arctic Front99% RF ablation
Freedom from AF
74% off AAD at 1 year with Arctic Front
73% off AAD at 1 year with first 3-month blanking period with Arctic Front
59% freedom from AF off AAD at one year with Arctic Front
77% off AAD in most patients at 13 months with Arctic Front
72% off AAD in most patients at 13 months with RF ablation
7-day Holter ECG at 3m intervals
EvR 1m pre3 Month post24h Holter, 12 lead ECG at 3m intervals
24h Holter monitoring at 1, 3, 6, 12 months Event recorders
2121
European Clinical Study ResultsArctic Front® Safety Results
Neumann Van Belle Kojodjojo• 7.5% Phrenic nerve
palsy (PNP)*; all recovered at < 1 year (26/346)
• No PV stenosis
• No atrioesphageal fistula, stroke, death, or other peri-procedural complications
* Primarily in 23 mm balloon
• 2.8% asymptomatic PNP*; all resolved within 6 months (4/141)
• 1.4% arteriovenous fistula (2/141)
• 0.7% left atrial flutter successfully ablated (1/141)
• No PV stenosis
• 0.8% pericardial effusion (1/124)
• 1.6% transient PNP (2/124)
2222
Shorter Procedures Demonstrated with Experienced European Users
Data from 9 German Centers: Arctic Front® is 33% faster than point-by-point catheter systems with a 24% reduction in fluoro time.
Medtronic data on file.
300
250
200
150
100
50
0
Min
utes
Lab OccupancyTime
Primary PhysicianTime
FluoroscopyTime
-33%
-33%
-24%
Point-by-Pointwith 3D Mapping
Arctic Front
23
Meta Analysis of Clinical Experience
• 539 articles screened, 23 were retained for the final analysis
• Efficacy results strong:– Acute success over 98%– 12-month freedom from AF: 72.83% with 3-month
blanking– No difference in 6-month and 12-month freedom from
recurrent AF between those who underwent Cryoballoon ablation for paroxysmal AF and who underwent RF ablation
Andrade JG, Khairy P, Guerra PG, et al. Efficacy and Safety of Cryoballoon Ablation for Atrial Fibrillation – A Systematic Review of Published Studies. Heart Rhythm. 2011. 23
24
Complications – Meta AnalysisOutcome n/N %Phrenic Nerve Palsy (PNP)
Any reported PNPPNP persisting post-procedurePNP persisting > 1 year
86/1,34967/1,349
5/1,349
6.38%4.73%0.37%
Pulmonary Vein Stenosis (PVS)Any PVS (per patient)PVS requiring intervention
7/7732/1,163
0.90%*0.17%
Periprocedure eventsStroke or TIAMyocardial infarctionLA‐esophageal fistulaEsophageal ulcerationPericardial effusion or tamponadeCardiac tamponadePulmonary artery rupture
4/1,2413/1,2310/1,298
6/11618/1,231
7/1,2311/1,231
0.32%0.24%†
0.00%5.17%‡
1.46%0.57%0.08%
* Studies reporting systematic screening for PVS with non‐invasive imaging† Two were transient due to air embolism and resolved without sequelae‡ Outcome reported in three studies of systematic endoscopy post Cryoballoon ablation
24
Andrade JG, Khairy P, Guerra PG, et al. Efficacy and Safety of Cryoballoon Ablation for Atrial Fibrillation – A Systematic Review of Published Studies. Heart Rhythm. 2011.
2525
European Arctic Front® Study Conclusions for Symptomatic Drug Resistant PAF Patients
1. Arctic Front System had a very high rate of acute PVI success
2. Arctic Front System had high rate of success in reducing long-term AF events
3. Arctic Front System had a low rate of complications; most resolved by 1 year
4. Arctic Front System significantly reduced procedure time for complete PVI compared to other PVI approaches
5. There was no occurrence of atrioesophageal fistula
2626
Blankingperiod (90 day)
STOP AF TrialKey Inclusion Criteria:• ≥ 2 documented AF Episodes
in the prior 2 months• Efficacy failure of ≥ 1 AAD
(flecainide, propafenone, sotalol)
Redo ablationn = 31 (19%)
* CRYO: Arctic Front® System
26 centers in US and Canada
AAD optimization
DRUG Crossovern = 65 (79%)
Cryoballoonablation (CRYO)
n = 163
AAD Rx (DRUG)n = 82
Follow-upat 1, 3, 6,
9 & 12Months
N = 245Randomized2:1 to CRYO*
or DRUG
2727
0 100 200 300 400 500Days
0%
20%
40%
60%
80%
100%
Trea
tmen
t Suc
cess
Trea
tmen
t Suc
cess
Effectiveness ResultsFreedom from AF after 90 Days Blanked for Detectable AF
CRYO 69.9% (114 / 163)
DRUG 7.3% (6 / 82)
OR = 29.5 (12.0 – 72.2) p < 0.001
Blankedfor
DetectableAF
28
CRYO Procedure Experience Impacts Treatment Success
25centersn=43
P < 0.001 by quartile (Wald)OR = 1.14 for each procedure
14centersn=38
10centersn=42
4centersn=40
1st and 2nd
procedures3rd – 5th
procedures6th – 11th
procedures12th – 23rd procedures
100%
80%
60%
40%
20%
0%
Trea
tmen
t Suc
cess
56%
66% 69%
90%
29
Device Related and Procedure Related Serious Adverse Events with Increasing
Experience
*p = 0.27 for SAE by first procedure sequence (initial procedure and reablation) **p = 0.13 for SAE by first procedure sequence (initial procedure only) ***p = 0.30 for SAE within 30 days by first procedure sequence (initial procedure only)
Kowal, et al. in preparation.
DR/PR SAE[n (%)]
Procedure Sequence by Quartile
1st and 2nd
25 centers, n=433rd – 5th
14 centers, n=386th – 11th
10 centers, n=4212th – 23rd
4 centers, n=40
Serious Adverse Events*(Initial and Repeat Abls.)
3 (7.0%) 3 (7.9%) 4 (9.5%) 0 (0.0%)
Serious Adverse Events**(Initial Procedure Only)
3 (7.0%) 2 (5.3%) 3 (7.1%) 0 (0.0%)
Serious Adverse Events within 30 days of procedure***(Initial Procedure Only)
2 (4.7%) 1 (2.6%) 2 (4.8%) 0 (0.0%)
3030
Additional STOP AF Results
CRYO Results:• 98.2% acute procedural success
• 62.2% of patients were treatment successes without any AF drugs at 12 months
• 60.1% single procedure success rate
• 19% of patients had redo procedures within the first 90-day follow-up period
DRUG Results: • 79% of DRUG group demonstrated chronic treatment failure
and crossed over to the cryoablation procedure
3131
Phrenic Nerve Palsy (PNP)
• 29/259 (11.2%) procedures:*– 15 subjects - asymptomatic– 13 subjects - symptomatic with DOE, SOB, and/or cough– 25/29 (86.2%) resolved by 1 year
• Median time for CXR resolution 102 days• 4/259 subjects (1.5%) had an abnormal CXR at
1 year, 1 (0.4%) remained symptomatic
* 29 PNP events out of 259 procedures in 28 subjects
3232
STOP AF Trial Conclusions
STOP AF met pre-specified primary effectiveness end point:• 98.2% of CRYO group had acute procedure success• 69.9% of CRYO group compared to 7.3% of DRUG group
were considered a treatment success at 12 months
STOP AF met the pre-specified primary safety end points:• Cryoablation procedure events were observed in 3.1%
(6.3%, UCB) of CRYO group; below the pre-specified 95% upper confidence bound of 14.8%
• The major AF event rate in the CRYO group was non-inferior to the DRUG group at 12 months, at 3.1% and 8.5% respectively
3333
Conclusions
Cryoablation for early Atrial Fibrillation:
1. Is effective in isolation of Pulmonary veins.2. Is a safe procedure. 3.Has shorter procedure times, compared to
conventional RF ablation procedures.4. Ideal procedure for PV / antral based atrial
fibrillation.
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