LAAC Device Surveilance:

Significance of Peri-Device Leaks & Device-Related

Thrombus

Saibal Kar MD, FACC

Los Robles Regional Medical Center, Thousand Oaks, CA
Physician Director, Interventional Cardiology, HCA Healthcare
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Post LAAC: Imaging surveilance

▪ Device related thrombus and peri-device leak are important

limitations of the current generation LAAC devices

▪ The incidence though small, can be a mechanism of recurrent stroke

▪ There is therefore a need for post procedure imaging to detect and

help treat these conditions
81 yr old lady presenting with a TIA 3 months
following placement of Watchman 2.5 LAAC
5 mm peridevice leak
5 mm peridevice leak
Transcatheter closure of a peri-device leak using a
16 mm AVP II plug
Watchman FLX overview

• Fully recapturable and reusable

• Less traumatic
• Closed distal end
• Redesigned anchors
• Lower chance of embolization
• Larger size range ( 20 to 35
mm)
• More comfortable: lower leak
• Reduced metal exposure: lower
DRT

Kar S, et al. Circulation 2021;143:1754–1762.

 Improvements in Leak Across Device Iterations
Newer devices have less leak than previous generations
Corelab Adjudicated 1-year Residual Jet
100%

89.5%
90%

80%

70%
63.0%
60%
51.0%
50% 46.0%

40% 36.0%

30%

20%
10.5%
10%
3.0%
0.0% 1.0%
0%
No leak (0mm) Small Leak (>0-5mm) Large Leak (>5mm)
1 2 2
WATCHMAN FLX (PINNACLE FLX) AMULET (AMULET IDE) Legacy WATCHMAN (AMULET IDE)

Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
1 Kar, CIRCULATION, 2021.
2 Lakkireddy, CIRCULATION, 2021.
 Leaks Analysis of FDA LAAC Trials
1-year PDL → Increases Subsequent Ischemic Stroke Rates
Study Population
• Patients with Watchman Implants (n=1,054)
• From 3 FDA Trials: PROTECT-AF, PREVAIL & CAP2
• TEE Imaging during Follow-Up: 45 days & 1 year

Leak at 1 Year TEE Adjusted 5-Yr Rates of Ischemic Stroke/SE

0.7% by Leak on 1 Year TEE
n=7
28.4% 100%

12.4%

Ischemic Stroke / SE
n=122
HR=2.0, 95% CI 1.2-3.4
No leak 15.3%
n=150 50%
Leak >0-3mm
Group 5yr Rate
71.6%
n=704 PDL: None 5.1% P=0.011
Leak >3-5mm
PDL: 0-5 mm 9.9%
Leak >5mm
0%
N=983 patients 0 1y 2y 3y 4y 5y

SR.Dukkipati, DR.Holmes, SK.Doshi … VY.Reddy. J Am Coll Cardiol 80:469-484 (2022)

What is the nature/impact of these strokes?
Stroke Severity & Mortality
Stroke Severity by Leak at 1 Year All-Cause Mortality
(N=976; excludes >5mm) (N=976; excludes >5mm)
100%

50%
Group 5y Rate
No PDL 18.3% P=0.93
Any PDL 16.2%
Disabling / Fatal Non-Disabling
Non-Disabling / Fatal
Stroke Stroke
Stroke 0%
0 1y 2y 3y 4y 5y

The Increased strokebyrisk

Severity determined with PDL is driven by an increase in non-disabling stroke
comparing
Modified Rankin scores: Baseline vs 3mo
→➔ No Increase in Mortality
SR.Dukkipati, DR.Holmes, SK.Doshi … VY.Reddy. J Am Coll Cardiol 80:469-484 (2022)
79 yr old lady with permanent AF underwent LAAC in May
2021. No 45 day follow up, or TEE planned by physician
Pt presented with TIA in Dec 2021: No deficit

▪ Surgery vs another
DOAC vs coumadin

▪ Pt refused surgery

▪ Pt started on
coumadin
 DRT across devices
Device-Related Thrombus Across Trials
7.0%
6.0%
Patients with DRT

5.0%
Percentage of

4.0%
3.0%
2.0%
1.0%
0.0%
PROTECT AF 1 PREVAIL 1 CAP 1 CAP2 1 EWOLUTION 2 WASP 3 Amulet IDE 4 Amulet 5 Amulet IDE 4 P FLX 1 FLXibility 6
(WATCHMAN) Registry (Amulet)

Legacy WATCHMAN Amplatzer Amulet WATCHMAN FLX

1. IFU (51221704); 2. Boersma LV, et al. Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology: Final 2-Year Outcome Data of the EWOLUTION Trial Focusing on History of Stroke and
Hemorrhage. 2019; 3. Phillips KP, et al. Left atrial appendage closure with WATCHMAN in Asian patients: 2 year outcomes from the WASP registry. 2019; 4. Lakkireddy D, et al. Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke
Prophylaxis (Amulet IDE): A Randomized, Controlled Trial. 2021; 5. Landmesser U, et al. Left atrial appendage occlusion with the AMPLATZER Amulet device: one-year follow-up from the prospective global Amulet observational registry. 2018; 6. Betts et al. One-Year
Results From the FLXibility Post-Approval Study: Final Real-World Clinical Outcomes With a Next-Generation Left Atrial Appendage Closure Device, Oral Abstract, EHRA, 2022
Device related thrombus(DRT) and stroke

• Most cases of post procedure stroke are not associated with DRT

• Presence of DRT increases the risk of stroke

• Treatment with anticoagulants can help prevent and treat DRT

 Imaging surveillance post LAAC : (TEE or CT)
Current Practice
Day 0 6 weeks 6 months one year

Imaging TEE/ICE TEE/CT optional TEE/CT

No leak /thrombus Look for late DRT
ASA+NOAC Stop NOAC start Clopidogrel stop clopidogrel
Leak/thrombus seen TEE/CT
Continue NOAC

Champion Trial
Day 0 4 months 6 months one year

Imaging TEE/ICE TEE/TEE/CT TEE/CT only if there if event

NOAC for 3 months If no thrombus seen: Aspirin alone
Addressing the limitations
• Modifications of current generation devices
• Modifications of frame work and or struts
• Disc and Lobe device
• Specific device coatings
• New generation LAAC devices
• Conformal
• Seal LA
• New concepts
• Laminar
 Watchman FLX vs Pro: Stages of Healing: A timeline
Coated devices showed faster healing in a challenging canine model (no OAC or APT)
3 days 14 days 28 days 45 days

~25% endothelialized ~50% endothelialized

Uncoated

~70% endothelialized 100% endothelialized

Coated

Thinner layer of provisional Near complete endothelial coverage at

Thrombus already resolving at 14 Complete endothelialization on
thrombus on coated device 30 days on coated device
days in coated group coated device in challenge in vivo
Concept device or technology. Not available for sale. model
The testing was performed by or on behalf of BSC. Data on file.
Novel concept: Laminar device
Fluoro

Implantation
Summary

• Device related thrombus and peri-device leak are important

limitations of current generation LAACs.

• Imaging surveillance is important to help detect and address these

issues

• New devices and novel concepts are in development to answer some

of the limitations of the current generation LAACs.