1. Post-care and anticoagulation of patients post LAA Closure
CRT 2015
Washington, DC, Feb 21-24, 2015
10min
Post-care and anticoagulation of patients post LAA Closure
Sameer Gafoor,
Horst Sievert, Ilona Hofmann, Laura Vaskelyte, Stefan Bertog, Predrag Matić, Markus Reinartz
CardioVascular Center Frankfurt - CVC
Frankfurt, Germany .

2. Disclosures Institution name Company Relationship
CardioVascular Center Frankfurt
Abbott, Access Closure, AGA, Angiomed, Boston, CardioKinetix, CardioMEMS, Cierra, Coherex, Coaptus, Cordis, CSI, Edwards, EndoTex, ev3, Gore, Guidant, Lumen Biomedical, Kensey Nash, Mind Guard, NDC, Neovasc, NMT, OAS, Occlutech, Ovalis, Pathway, Percardia, Rox Medical, Sadra, Sorin, St. Jude, Terumo, Topspin, Velocimed, Venus, Xtent
Consulting fees,
Travel expenses,
Study honoraria
Cardiokinetics, Access Closure, Velocimed, Cierra, CoAptus, Lumen Biomedical, Square One
Stock options,
Stocks

3. Congratulations! You closed the LAA!
Anesthesiologist is happy because stock market is looking better
Echocardiographer is rescheduling his shoulder physical therapy for later this afternoon
But there is much more to do

4. Remember This is a preventive procedure
So patients should not face complications
Important to have good hospital course and followup

5. Postcare: final views Always finish with
Echocardiographic position and check for effusion
Fluoroscopic view in AP position
Sometimes we will keep sheath in after deployment for five minutes and see if there is device migration

6. Postcare: venous closure
Figure of eight sheath
0-0 silk suture on large curved cutting needle

7. Postcare: venous closure
Step 1: pass needle on caudal side of sheath insertion site through subq tissue
Step 2: crossing needle and suture back on same side of sheath
Step 3: pass needle through sq tissue

8. Before leaving the lab Patient is on dual antiplatelet therapy in lab
Give protamine peri-sheath removal
Two levels of communication
Cardiologist to ICU/monitored floor team
Anesthesia to ICU/monitored floor team

9. Send patient to Monitored floor or ICU
Pericardial effusion can happen in first 24 hours
Should be able to have quick echocardiography within minutes
Echo machine should be on and at bedside for first few cases
Setup for early pericardiocentesis
If any concern  TTE

10. Postprocedure day 0 Receive anticoagulation Groin management
Extubation (in procedure room if possible)
Early ambulation

11. Postrocedure Day 1 Xray AP and lateral
Transthoracic echocardiogram to check for effusion and
Anticoagulation regimen
Discharge day 1 or 2

12. Anticoagulation regimen is still debated
What anticoagulation protocols are there?
What echo followup protocols are present?
What do we do with thrombus and leak?
What device modifications can we make to prevent leaks?

13. PROTECT-AF algorithm

14. PROTECT-AF Anticoagulation “cessation”
87% of patients at 45 days, more at later time points
Reasons for continuing on warfarin
Flow in LAA (n=30)
Physician order (n=13)
Other (n=9)

15. What if cannot tolerate anticoagulation?

16. Contraindications to oral anticoagulation
Hemorrhagic/bleeding (active PUD, overt bleeding)
Blood dyscrasia
Unsupervised patients with senility and/or high fall risk
Other documented reason (including hypersensitivity to warfarin)

17. ASAP trial regimen Aspirin and clopidogrel for 6 months
Average stroke risk CHADS2 2.8
7.4%/year
7.3%/year with aspirin
5.0%/year with aspirin and clopidogrel
Actual ischemic stroke rate 1.7%

18. Iberian registry for ACP
Lopez-Mingues – Iberian registry 167 pts had the most rigorous DAPT regimen
Aspirin Clopidogrel 600 x 1 day
Aspirin Clopidogrel x 3-6 months
Aspirin alone for up to 12 months
TEE at 1, 3, 6, and 12 months
Thrombus occurred – subcutaneous lovenox for 2 weeks, aspirin and clopidogrel continued

19. Iberian registry (continued)
CHADS2 rate of 3; translates to 9.6% at one year, observed was 3.9%

20. Iberian registry (continued)
TEE check 1, 2, 6, and 12 months
Thrombus still seen on 8% of patients
Overall range is 5-17%
Higher when dual antiplatelet therapy withdrawn in first 2 months, falls with 2-3 week course of enoxaparin

21. Overall ACP registry

22. What about leaks?

23. Residual leaks after catheter closure PROTECT AF
After 12m 32% had at least some degree of peri-device flow
Size of Leaks
Minor (<1mm) %
Moderate (1-3mm) 62.4%
Major (>3mm) 36.8%
Patients with residual leaks >5 mm were treated with anticoagulation
Viles-Gonzalez JF J Am Coll Cardiol. 2012;59:

24. .... because in PROTECT AF these patients received anticoagulation
We can only assume (from surgical experience) that a large leak (>5mm) is a risk factor for stroke ...
.... because in PROTECT AF these patients received anticoagulation
Is a small leak (<5mm) a risk factor for stroke?

25. PROTECT-AF Primary Efficacy Endpoints by Leak Severity
A higher chads 2 score equals a higher stroke risk
Comparison of primary efficacy (red), ischemic stroke (yellow), and a composite endpoint of stroke and systemic embolization (orange), showing no significant statistical relationship between the presence or severity of peri-device flow.
Primary Efficacy Event Rates in Patients With and Without Peri-Device Flow
Any Residual Flow
No Flow p
Efficacy
9/182 (5%)
18/263 (7%)
0.572
Ischemic stroke/systemic embolism
5/182 (3%)
11/263 (4%)
0.669
Viles-Gonzales, J et al. JACC 2012; 59(10):923-9.

26. What do we do with a large leak?
Yes we can anticoagulate... But is there anything else we can do?
As you can expect we started to close them

27. Residual leak after Watchman
+ AVP II
72 M with AF
TIA 2006, CAD, GI Bleeding
Watchman (31mm) Implantation May 2011
Leak at TEE 19 months later
M/72 AF, TIA 2006, CAD, GI Bleeding
Watchman (31mm) Implantation
Leak at TEE 19 months later

28. 8Fr Introductory sheath, Amplatz Extra Stiff
Amplatzer Vascular Plug (AVP II) 10 mm

29. Deployment of Device and Final Result

30. So there are many different protocols
How do we make sense of this?

31. We find our own middle ground: the CVC Protocol
Anticoagulation with warfarin may be too much – and many patients do not want this
Dual antiplatelet therapy for 3 months, then aspirin alone for 6 months
TEE at one month
Check for significant leak or thrombus

32. We find our own middle ground: the CVC Protocol
If thrombus
Warfarin or enoxaparin for 3 months; remove aspirin and clopidogrel if possible, then repeat TEE
If at repeat TEE still thrombus, continue for another three months with warfarin
If leak
If greater than 5 mm with high-risk criteria such as filling the LAA or reaching the back of the LAA – consider closure

33. Better than treating is to prevent the problem
How do we make the devices better?

34. How do we make devices better?
Risk of thrombus until neoendothelialization forms
Often checked in canine studies (many limitations)
At 28 days, all surfaces of Wtchman were covered
At 30 days, one canine had focal uncovered area at lower edge of disc and at the screw

35. Watchman vs. ACP Canine model 30 days
Kar S et al. JACC Interv 2014

36. However let’s not jump to conclusions yet
ACP
Amulet
New St. Jude system is called Amulet
Different end screw in place that is shorter

37. Amulet: Recessed End Screw
uniform surface in the left atrium
potentially less risk of thrombus formation
Preclinical canine model: Mature and stable neointima covering the device surface (arrows); the device was filled by organized thrombus (asterisk). 90 day cohort (H&E)

38. Thank you!