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2/7/2018
1
Advances in Atrial Fibrillation Treatment: Ablation and Left Atrial Occlusion Strategies
J. Michael Mangrum, MD
Associate Professor of Medicine
Ted Turner Clinical Scholar in Atrial Fibrillation
Director, Atrial Fibrillation Center
University of Virginia
February 17, 2018 Guerrieri Heart & Vascular Institute’s 22nd Annual Coastal Cardiac & Vascular Conference
Disclosures
• Research Grants: Medtronic, Boston Scientific, St. Jude Medical, CardioFocus
• Advisory Board: Medtronic, CardioFocus
• Speaker: Medtronic, CardioFocus, St. Jude Medical
Outline
•AF introduction
•AF ablation
• LAA occlusion
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Atrial Fibrillation: Facts
Single most common sustained cardiac dysrhythmia
In 2010, estimated 2.6 million Americans had AF and expected 12 million in 2050
Men have a 1.5 fold higher risk of developing AF
Risk of AF increases with age. (Note: only 1% of patients with AF are less than 60 years old)
Stroke is 5X more common in patients with AF
About 1 in 7 strokes are caused by AF
Hypertension is the most notable risk factor for developing AF
The estimated cost of treating Americans with AF is $26 billion per year
Deshpande, et al. Card Electrophysiol Clin 2014;6:1‐4
Definitions
• Paroxysmal AF• AF that terminates spontaneously or with intervention within 7 days of onset
• Early Persistent AF• AF sustained beyond 7 days but < 3months in duration
• Persistent AF• AF sustained beyond 7 days
• Long‐standing Persistent AF• Continuous AF of greater than 12 months duration
• Permanent AF• Decision made to remain in AF with no further attempts at rhythm control
Calkins, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm 2017;14:e275‐e444.
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Calkins, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm 2017;14:e275‐e444.
Calkins, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm 2017;14:e275‐e444.
Indications for Catheter Ablation of Atrial Fibrillation
• Symptomatic AF refractory/intolerant to at least one class I or III antiarrhythmic medication
• Paroxysmal Class I
• Persistent Class IIa
• Long‐standing persistent Class IIb
• Symptomatic AF prior to initiation of class I or III antiarrhythmic medication
• Paroxysmal Class IIa
• Persistent Class IIa
• Long‐standing persistent Class IIb
Calkins, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm 2017;14:e275‐e444.
2/7/2018
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Indications for Surgical Ablation of Atrial Fibrillation:concomitant open (such as mitral valve)
• Symptomatic AF refractory/intolerant to at least one class I or III antiarrhythmic medication
• Paroxysmal Class I
• Persistent Class I
• Long‐standing persistent Class I
• Symptomatic AF prior to initiation of class I or III antiarrhythmic medication
• Paroxysmal Class I
• Persistent Class I
• Long‐standing persistent Class I
Calkins, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm 2017;14:e275‐e444.
Indications for Surgical Ablation of Atrial Fibrillation:concomitant closed (such as CABG or AVR)
• Symptomatic AF refractory/intolerant to at least one class I or III antiarrhythmic medication
• Paroxysmal Class I
• Persistent Class I
• Long‐standing persistent Class I
• Symptomatic AF prior to initiation of class I or III antiarrhythmic medication
• Paroxysmal Class IIa
• Persistent Class IIa
• Long‐standing persistent Class IIa
Calkins, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm 2017;14:e275‐e444.
Indications for Surgical Ablation of Atrial Fibrillation:stand‐alone or hybrid
• Symptomatic AF refractory/intolerant to at least one class I or III antiarrhythmic medication and failed one or more attempts at catheter ablation or prefer a surgical approach
• Paroxysmal Class IIb
• Persistent Class IIa
• Long‐standing persistent Class IIa
Calkins, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm 2017;14:e275‐e444.
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Cox JL. Current Problems in Cardiology 1983:3‐60
Cox JL. Current Problems in Cardiology 1983:3‐60
• The resulting concept…is based on that of a maze in which there is one entrance point into the box (SAN), one true conduction route between the entrance and exit, and several blind alleys along the route. Thus we refer to this surgical procedure as the maze procedure.
• Between 1987‐91, 22 pts underwent this procedure
Cox, JL, et al. JAMA 1991;266:1976‐1980.
Cox JL, et al. J Thorac Cardiovasc Surg 1995;110:473‐84
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Multiple electrode catheter
2 thermocouples
per electrode
Introducer
sheath
14 coil electrodes
• A Focal Source of Atrial Fibrillation treated by Discrete Radiofrequency Ablation• Jais P, et al. Circulation 1997;95:572‐576
Haissaguerre M, et al. N Engl J Med 1998;339:659‐66
Pulmonary Vein Isolation (PVI)
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Cardiac Ablation for Atrial Fibrillation
• Goals• High clinical efficacy• Low complication rates
• Achieve durable pulmonary vein isolation with least amount of tissue damage/destruction
• How to achieve durable pulmonary vein isolation?• Lesions to be contiguous and transmural
• Why is there re‐connection?• Role of edema or inefficient energy deliver?
• Lack of energy titration based on patients’ anatomy?
Tools for PVI in US
• Radiofrequency (point‐by‐point ablation)
• Cryoballoon
• Laser
HeartLight Technology – Main components
Console
Balloon Catheter Sheath
Endoscope
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Case (UVA 8.15.17)
• Mr. G is a 52 y.o. male with a 3 year h/o PAF. Current AF episodes monthly
• Med Hx: HTN
• Meds: Failed flecainide and metoprolol
• ECHO: Normal LV function; LA size 4.1 cm
• Plan: PVI
Case (UVA 8.15.17)
Case (UVA 8.15.17)RSPV First set of lesions
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Case (UVA 8.15.17)
Case (UVA 8.15.17)
• RIPV not isolated
• Would like more antral RPV lesions
• LPVs limited by esophageal temperature rise
• Re‐deployed balloon in RPVs
• Increased the balloon size
• Ablated more on periphery of endoscopic view
Case (UVA 8.15.17)RSPV Second set of lesions
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Case (UVA 8.15.17)
Case (UVA 8.15.17) [Before ablation]
Case (UVA 8.15.17) [After 1st encirclement]
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Case (UVA 8.15.17) [After second encirclement of RPVs]
LaserFluid Cooled RF
Lesion Quality
Dukkipati SR, d’Avila A, Reddy VY et al. Circ Arrhythm Electrophysiol. 2010,3:266-73
Laser Ablation
PACE. 2015 Jul 14. doi: 10.1111/pace.12696.
LASER Ablation
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Baseline Regional LA/PV thickness
S
I
AP
S
I
PA
S
I
PA
RSPV
RIPV
S
I
AP
S
I
AP LSPV
LIPV
n= 8162 measurements in 30 patients
2.88±0.76
2.43±0.88
2.73±1.20
2.46±1.20
2.56±0.88
2.57±0.98
2.47±1.15
2.66±1.02
2.64±1.08
2.79±1.05 3.68±1.83
5.10±1.40
3.60±0.89
3.28±0.94
2.98±1.17
2.28±0.76
4.06±2.16
2.78±0.87
3.88±1.75
3.06±0.90LC
> 3 mm
< 3 mm
Importance of energy titration
Without energy titration, there will likely be regions without transmural lesions or there will be injury to adjacent structures
LSPV Pre 2 LSPV Post 2
HRS 2015; PO06‐60
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Laser
RIPV pre RIPV post
HRS 2015; PO06‐60
Percent change in wall thickness post ablation
0.0
10.0
20.0
30.0
40.0
50.0
60.0
LSPV(S)
LSPV(P)
LSPV(I)
LSPV(A)
LIPV(S)
LIPV(P)
LIPV(I)
LIPV(A)
RSPV(S)
RSPV(P)
RSPV(I)
RSPV(A)
RIPV(S)
RIPV(P)
RIPV(I)
RIPV(A)
RF
Laser
Region of each PV
Percent (%
) Increase in wall
thickness
% change PV [RF vs. Laser]
RF = 40.2%Laser = 14.4%
RF = 32.5%Laser = 11.8%
RF = 15.3%Laser = 2.7%
RF = 17.0%Laser = 5.3%
RF =29.5%Laser = 8.5%
Ablation Strategies for Persistent AF
PVI only
PVI + non‐PV triggers
PVI + linear lesions (Eg: 2C3L)
PVI + CFAE
PVI + linear lesions + CFAE
Step‐wise approach
PVI + “catheter MAZE” (including RA ablation)
PVI + entire posterior wall
Rotor/driver domain ablation
PVI + rotor/driver domain ablation
Hybrid AF ablation
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Substrate and Trigger Ablation for Reduction in Atrial Fibrillation Trial II [STAR AF II]
589 persistent AF patients randomized in 1:4:4 ratio to PVI only (67pts); PVI + CFAE (263pts); PVI + linear (259pts)
F/U 18 months
Primary endpoint: Freedom from any AF > 30 seconds after 1 procedure
Verma A, et al. N Engl J Med 2015;372:1812‐22
Verma A, et al. N Engl J Med 2015;372:1812‐22
59%
49%46%
P = 0.15
Substrate and Trigger Ablation for Reduction in Atrial Fibrillation Trial II [STAR AF II]
48 centers from 12 countries
Persistent AF patients. (Excluded if paroxysmal, persistent AF > 3 years, or LA > 6.0 cm)
Ablation performed with: Open‐irrigated ablation
EnSite Velocity, St. Jude Medical*
Post‐procedure 3 month ‘blanking’ period and drugs then stopped
If recurrence post 3 months, could start (or re‐start) AA drug and if appropriate re‐ablation [same randomized strategy] at 3‐6 months post initial procedure
Monitoring
Clinical Assessment, 12 lead ECGs , 24 Hr Holters at 3,6,9,12, and 18 months, and transtelephonic monitoring weekly for 18 months and with any symptom
Verma A, et al. N Engl J Med 2015;372:1812‐22*Funded the study
Substrate and Trigger Ablation for Reduction in Atrial Fibrillation Trial II [STAR AF II]
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Why the result?
Additional ablation result in new iatrogenic areas of arrhythmogenesiswhere the tissue is incompletely ablated or linear block not achieved?
Perhaps neither CFAE or lines are the correct supplemental targets?
Automated CFAE maps may not be accurate?
Can we be assured of durable PVI?
Ablation endpoint was not AF termination.
For persistent AF, is total elimination of AF necessary or is AF burden reduction an acceptable endpoint?
Driver Domains in Persistent Atrial Fibrillation (Haissaguerre M, et al. Circulation 2014;130:530‐538)
Aims
Evaluate use of non-invasive 3D Mapping (ECM) to identify drivers in distinct categories of persistent atrial fibrillation (AF).
Methods
• Prospective, non-randomized
• RF Ablation times compared to matched controls
• n=103
• Driver ablation + PVI; + linear lesions if AF not terminated
Results
Acute results: 82/103 patients experienced AF termination (80%).
Outcomes:
58/90 (64%) in stable sinus rhythm at 12 mos
16/90 repeat ablations for atrial tachycardia (12) or AF (4)
85% with AF termination free from AF at 12 mos
Anatomical Distribution of AF Drivers (above) Distribution of Mean Number of
Rotations per Patient (n=103) (below)
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AFACART Trial. (Knecht S, et al. Europace. 2017;19:1302‐1309)
Aims
To evaluate the utility of ECG mapping as a practical tool prior to ablation for persistent AF in centers with no practical experience of the system
Methods
• Multicenter (8 centers), prospective non-randomized
• N=118, PsAF <1 year, refractory to >1 AAD, LA diameter <55mm
• Primary endpoint: Acute AF to SR or AT
Results
• Driver‐only ablation resulted in AF termination in 64% of the patients (75/118)
• Acute termination rates were not significantly different across all 10 centers.
• At 1 year, 77% of patients were free from AF recurrence after only a single procedure (78% off AADs)
• 14/25 recurrences were persistent of which 4 could not be managed by DC cardioversion ± new AADs ± repeat ablation
• 3 month blanking period (Failure =AF or AT > 30secs)
• Holters at 3 , 6*, 9, & 12* months (*=72 hours)
Results Cont. 14/25 recurrences were persistent. Remaining 11 AF
recurrences were paroxysmal 37% of all patients developed atrial tachycardia managed
by AAD ± repeat ablation
Chronic Freedom from AF
46
Noninvasive mapping
47
Obtain CT scan for heart‐torso geometry2
Select beats and create mapsRecord cardiac signals from vest3 4
Prep patient and apply vest1
Phase Mapping (Atrial Fibrillation)
Phase Map Composite Map
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CardioInsight Physician Training | Confidential
AF Recording and map generation
Define phase intervals Phase maps Composite map
Identify intervals with >1000ms (recommend 1200ms) over enough samples (ex. 10+) to be representative of rhythm under investigation.
(Segment CT and combine AF recordings)
Create a playable phase map for each processed map interval
Displays composite of all detected phase map activity
Interval1
X >10
49
X >10
UVA Case 027
TVMV
Termination while ablating posterior left atrium around the left PVs
UVA Case 027
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UVA Case 018
UVA Case 001
TV
UVA Case 017
TV
UVA Case 020
TV MVMV
MV
Initial experience at UVA compared to European experience
• All types of atrial fibrillation (PAF, persistent, long‐standing persistent)
• Both Index cases and Repeat ablation cases
• Did mapping both pre‐procedure and intra‐procedure
• Modified 7 segment model to subsegments (total of 19)
• Endpoint was ablation to sinus rhythm
• Used contact force sensing ablation catheters
University of Virginia Experience• Initial Experience (February, 2017 – November, 2017)
• Atrial – 40 • Afib (Paroxysmal) – 6 (Index cases – 4, Repeat cases – 2)• Afib (Persistent) – 25 (Index cases – 12, Repeat cases – 13)• Afib (Long‐Standing Persistent) – 4 (Index cases – 0, Repeat cases – 4)• Atach – 3 (Index cases – 1, Repeat cases – 2)• Note: 1 patient non‐inducible, 1 patient atrial flutter and not mapped
• Ventricular – 5 • PVC – 5
• CRT – 6 • CardioInsight™ Mapping System was used pre‐procedure and intra‐procedure
• For the above Atrial Arrhythmia patients, the ablation strategy was to ablate to sinus rhythm
• Achieved in 28/38* (74%) CardioInsight™ cases • Presented in Afib/AT [27]. 18/27 (67%) ablated to SR• Presented in SR [13]. Induced. 11/13 (85%) ablated to SR
*Could not induce sustained Arrhythmia in 1 case and unable to map the flutter in 1 case
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0
2
4
6
8
10
12
14
AT Paroxysmal Persistent Long‐StandingPersistent
Acute Procedural Success: Type of Atrial Arrhythmia Cases and Ablation to Sinus Rhythm
Index Repeat
100% 100%
100% 100%
92% 62%
0%
Number of Patien
ts
Did not terminate with ablation
0
2
4
6
8
10
12
14
AT Paroxysmal Persistent Long‐StandingPersistent
Clinical Success – Arrhythmia‐free
Index Repeat
Mean f/u = 5.1 months
100% 100%
75% 50%
83%92%
0%
Note: Same patient in 2 cases with deep RAA trigger (not a mapping issue)
Note: Same patient in 2 cases with ASD repair and arrhythmias due to surgery
Number of Patien
ts
Did not terminate with ablation
Indications for Surgical Ablation of Atrial Fibrillation:stand‐alone or hybrid
• Symptomatic AF refractory/intolerant to at least one class I or III antiarrhythmic medication and failed one or more attempts at catheter ablation or prefer a surgical approach
• Paroxysmal Class IIb
• Persistent Class IIa
• Long‐standing persistent Class IIa
Calkins, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm 2017;14:e275‐e444.
2/7/2018
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Hybrid Cardiac Ablation
Driver and Mangrum. J Thorac Dis 2015;7:159‐164
Driver and Mangrum. J Thorac Dis 2015;7:159‐164
1 = PVI2 = Roof3 = Inferior4 = Anterior5 = LSPV to LAA6 = Inferior to CS7 = SVC8 = Intercaval
a = mitral isthmusb = CTI
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Driver and Mangrum. J Thorac Dis 2015;7:159‐164
Persistent Patients (45 pts)
60±126045±7204.8±0.9
1.7±0.5
2.1±0.647
Age (years)Male (%)LVEF (%)CHF?LA Diameter
# of Failed Ablations
# of AADBMI >30 (%)
Surgery +Catheter (15)
RepeatCatheter (30)
59±146751±9164.5±0.8
1.8±1.2
1.7±0.833
P
nsnsnsnsns
ns
ns
Mahapatra S, et al. Ann Thorac Surg 2011;91: 1890‐1898
Mahapatra S, et al. Ann Thorac Surg 2011;91: 1890‐1898
2/7/2018
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Mahapatra S, et al. Ann Thorac Surg 2011;91: 1890‐1898
Port Placement
• Right Side
• Left Side
Bipolar clamp
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GP Mapping and AblationHigh Frequency Stimulation
Positive Vagal Response
Epicardial Exit Block
PericardialInsertion of
Lig of Marshall
LAA
Left Pulmonary
Artery
LSPV
Ligament ofMarshall
Ligament of Marshall
2/7/2018
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Atricure Exclude Appendage Device
Multipolar catheter in each PV
Check Box Lesion
• Check Posterior wall
• Entrance block
• Exit block with pacing
• Often Roof Line gap
• LI‐MI line includes CS burn
• Use fluoro to confirm place LI‐MI line same place as surgeon
• Isoproternol run limited by pressure
2/7/2018
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Track Atrial Flutters
2/7/2018
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2/7/2018
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LSPV post
LIPV post
RSPV post
2/7/2018
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RIPV post
SVC post
2/7/2018
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Di Biase, et al. HRS 2010
2/7/2018
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Di Biase, et al. HRS 2010
Di Biase, et al. HRS 2010
CAP STOPS LSP AF – Procedure MetricsPost Procedure Voltage Map – Isolation of Posterior LA & PVs
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Oral Anticoagulation is Standard of Care, but Not Ideal for All NCDR Pinnacle Registry
Warfarin
• Bleeding risk
• Daily regimen
• High non‐adherence rates
• Regular INR monitoring
• Food and drug interaction issues
• Complicates surgical procedures
Novel Oral Anticoagulants
• Bleeding risk
• Daily or 2x/daily regimen
• High non‐adherence rates
• Complicates surgical procedures
• Limited reversal agents
• High cost
1. Hsu, J et al. JAMA Cardiol. Published online March 16, 2016. doi:10.1001/jamacardio.2015.0374
Use of OACs in AF Patients peaks at ~50%,use declines with increasing risk
Despite NOAC Adoption and Ability to Switch NOACs, Adherence to Anticoagulation Remains a Challenge
Source: Martinez C, et al. Therapy Persistence in Newly Diagnosed Non-Valvular Atrial Fibrillation Treated with Warfarin or NOAC. A Cohort Study. Thromb Haemost. 2015 Dec 22;115(1):31-9. doi: 10.1160/TH15-04-0350.
~30% of NOAC patients stop taking any drug at 2 years
Connection Between Non‐Valvular AF‐Related Stroke and the Left Atrial Appendage
1. Stoddard et al. Am Heart J. (2003)2. Goldman et al. J Am Soc Echocardiogr (1999)3 Blackshear JL. Odell JA., Annals of Thoracic Surg (1996)
• Stasis-related LA thrombus is a predictor of TIA1 and ischemic stroke2.
• In non-valvular AF, >90% of stroke-causing clots that come from the left atrium are formed in the LAA3.
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Left Atrial Appendage Closure Devices(FDA Approved Devices as of January, 2018)
Endocardial Epicardial
Watchman™ Lariat™ Atriclip™
WATCHMAN™ LAAC Device
Indications for Use
The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non‐valvular atrial fibrillation who:
• Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2‐VASc scores and are recommended for anticoagulation therapy;
• Are deemed by their physicians to be suitable for warfarin; and
• Have an appropriate rationale to seek a non‐pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin
• One-time implant that does not need to be replaced
• Performed in a cardiac cath lab/EP suite, does not need hybrid OR
• Performed by a Heart Team
• IC/EP or IC&EP, TEE, General Anesthesia, Surgical Back- up, WATCHMAN Clinical Specialist
• Transfemoral Access: Catheter advanced to the LAA via the femoral vein
WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device Procedure
• General anesthesia*
• 1 hour procedure*
• 1-2 day hospital stay*
* Typical to patient treatment in U.S. clinical trials
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WATCHMAN™ ‐Most Studied LAAC Device
Key Trials N Highlights
PROTECT AF1
(2005‐2008)707 Prospective, randomized 2:1, non‐inferiority trial of LAA closure vs. warfarin.
CAP2
(2008‐2010)566
Prospective registry allowing continued access to the WATCHMAN Device and gain further information prior to PMA approval.
PREVAIL3
(2010‐2012)407
Prospective, randomized 2:1, non‐inferiority trial to collect additional information on the WATCHMAN Device.
CAP2(2012‐2014)
579Prospective registry allowing continued access to the WATCHMAN Device prior to PMA approval.
EWOLUTION(2013‐2015)4*
1025Prospective registry allowing all patients receiving a WATCHMAN Device at participating centers in Europe, Middle East and Russia
Total patients >3,000 ~9,000 Patient‐Years of Follow‐up
1 Reddy, et al. JAMA. 2014 ;312(19): 1988‐1998.2 Reddy VY et al. Circulation. 2011; 123:417‐424.3 Holmes et al., JACC 2014,;4(1): 1‐11.4Boersma, L. V. A., et al. CCI (2015); 88(3): 460‐465.
* Majority of patients enrolled could not take anticoagulation and therefore contraindicated in the US per current labeling.
Procedural Success
Implant success defined as deployment and release of the device into the LAA; no leak ≥ 5 mm
* The EWOLUTION Registry is a European prospective registry which reflects CE Mark indications for use which differ from the FDA indications for use.1 Boersma, L.et al. EHJ 2016;37(31): 2465.; 2 Reddy VY, Holmes DR, et al. JACC 2016; 69(3): 253-261.
~50% new operators
~70% new operators performed 50% of
procedures
Favorable Procedural Safety Profile: All Device and/or Procedure‐related Serious Adverse Events within 7 Days
9.9%
4.8%4.1% 4.1% 3.8%
2.8%
0%
2%
4%
6%
8%
10%
12%
PROTECT AF1st Half
PROTECT AF2nd Half
CAP PREVAIL CAP2 EWOLUTION*
Patients With Safety Event(%)
N=232 N=231 N=566 N=269 N=579 N=10191
~50% New Operators in PREVAIL
* The EWOLUTION Registry is a European prospective registry which reflects CE Mark indications for use which differ from the FDA indications for use.1 Boersma, LVA.et al. EHJ 2016; 37(31): 2465.
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WATCHMAN™
*The performance and timing of TEE to re‐evaluate the LAA seal is left to physician discretion.Typical to patient treatment in U.S. clinical trials
Warfarin Cessation with WATCHMAN
92% 99%
45 Days
92% of patients were able to discontinue warfarin after 45 days, with 99% able to discontinue after 1 year3
1. Reddy, VY et al. Circulation. 2011;123:417‐424. 2 WATCHMAN FDA Panel Sponsor Presentation. Oct 2014.. 3 Holmes, DR et al. JACC 2014; 64(1):1‐12.
WATCHMAN Enables Patients to Discontinue Long‐term OAC
92%92%
99%
1 Year
EndoCATHOcclusion Balloon
FindrWIRZGuidewire System
LARIAT
Suture delivery device
TenSURE
Suture tightener SureCUTSuture cutter
SofTIP
Guide Cannula
LARIAT Procedure
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LARIAT Suture Delivery Device
• FDA Indications: The LARIAT Suture Deliver Device facilitates suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated with a pre‐tied polyester suture
ACCESS DELIVER CAPTURE/CLOSE REMOVE
Standard techniques and technology for pericardial
and transseptal access are utilized for placement. The
.025” FindrWIRE & EndoCATH are positioned.
The SofTIP is oriented to the target and the .035”
FindrWIRE is delivered to connect to the .025”
FindrWIRE at the target. The LARIAT is then
advanced.
With the snare opened, the LARIAT is advanced
over the target and closed. After confirmation, the suture is released &
tightened.
All catheters are removed, reverse heparin and all that remains with the
patient is a small remnant of suture. Band-Aid
closure
PLACE Procedure PERMANENT LIGATION APPROXIMATION CLOSURE & EXCLUSION
PLACE Procedure
Bartus et al. Heart Rhythm 2011;8:188-193. Bartus et al. J Am Coll Cardiol 2012; epub.
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Katz, et al. JACC 2000;36:468‐71
• Spontaneous echo contrast or thrombus seen in incompletely ligated LAA in 9 of 18 (50%) patients
• 4 patients with incompletely ligated LAA had thromboembolic events
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AtriClip
LA Appendage AnatomyCactus (30%) Cauliflower (3%)
Chicken Wing (48%) Windsock (19%)
DiBiase et al. J Am Coll Cardiol 2012;60:531‐8.A – CT; B ‐ CMR
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Calkins et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation
AF/LAA Collaborative Team Approach
• Team Members• EP, IC (structural heart interest), surgeon
• Individualize Patient• Ablation Strategy and/or device?• Are there contraindication to anticoagulation?• Arrhythmia management
• Ablation
• Other AF treatment
• Concomitant surgical needs• CABG
• Valve