1. Access and Closure Devices: How to Minimize the Complications
Cardiovascular Research Technology (CRT) 2011
Washington, DC, Feb 27 – March 1, 2011
Structural Heart & Valve Revolution I2/27/2011 5:15:00 PM2/27/2011 5:25:00 PMAccess and Closure Devices: How to Minimize the ComplicationsDiplomat Ballroom
Access and Closure Devices: How to Minimize the Complications
TAVI Complications and Management
Moderators: Nicolo Piazza, MD & Augusto D. Pichard, MD
4:15 PM Lessons from Complications: The Balloon Expandable Edwards SAPIEN and the Self-Expanding Medtronic CoreValve Transcatheter Valve Systems Nicolo Piazza, MD
4:25 PM Managing TAVI Rhythm Disturbances: New LBBB, Bradyarrhythmias and Temporary and Permanent PacemakersJeffrey J. Popma, MD
4:35 PM Embolic Penetration Devices for Stroke Prevention Eberhard Grube, MD
4:45 PM My Worst TAVI Complication Nicolo Piazza, MD
4:55 PM My Worst TAVI Complication Mathew Williams, MD
5:05 PM General Anesthesia, TEE, Hemodynamic Support: A “Minimalist” Perspective for TAVI Augusto D. Pichard, MD
5:15 PM Access and Closure Devices: How to Minimize the Complications Horst Sievert, MD
5:25 PM Adjourn
Horst Sievert, Nina Wunderlich
CardioVascular Center Frankfurt
Frankfurt, Germany

2. Conflict of Interest Statement
Physician name
Company
Relationship
Horst Sievert
Access Closure, AGA, Ardian, Arstasis, Atritech, Atrium, Avinger, Bard, Boston Scientific, Bridgepoint, CardioKinetix, CardioMEMS, Coherex, Contego, CSI, EndoCross, Epitek, Evalve, ev3, FlowCardia, Gore, Guidant, Lumen Biomedical, HLT, Kyoto Medical, Lifetech, Lutonix, Medinol, Medtronic, NDC, NMT, Occlutech, Osprey, Ovalis, pfm Medical Mepro GmbH, ReCor, Rox Medical, Sorin, Spectranetics, SquareOne, TriReme Medical, Trivascular, Veryan Medical, Viacor
Consulting fees,
Travel expenses,
Study honoraria
Cardiokinetix, Access Closure, CoAptus, Lumen Biomedical, Coherex
Stock options,
Stocks 1

3. Screening Angiogram of infrarenal aorta and iliac vessels
Diameter?
Calcium?
Tortuosity?
Aneurysm?
Can the curves of the iliac vessels be straightened by a stiff wire?

4. Screening CT angio in case of difficult anatomy
as a routine? (Edwards)
Same parameters as with angio
In addition, you can see where the calcium is

5. } Where are the limits? Edwards Sapien CoreValve 23mm valve  22F
 OD 25.5 F = 8.5mm
 OD 27.9 F = 9.3mm }
 18F
 OD 20 F = 6.7mm
Vessel  10% less than OD may be acceptable

6. If the vessels are too small
Cut down of the common iliac
Subclavian access
Transapical access

7. Perclose vs Cut Down
Important for the decision is only the common femoral artery at the puncture site
Sheath diameter = vessel diameter is ok
The diameter of the iliac arteries is important for the big sheath, not for the Perclose

8. How and where to puncture
Think about which side (right or left) is better suitable to introduce that big sheath
Start with the contralateral side

9. How and where to puncture
20 G needle
Needle entry into the vessel should be just below the center of the femoral head
Confirm central stick by contrast injection through needle

10. How and where to puncture
Introduce 4 F sheath and confirm position before you proceed
Go cross-over
Puncture the contra- lateral common femoral artery under roadmap or fluoro guidance
Or bring a pig-tail down to the common femoral and "puncture the tail"

11. Colombo-Technique
Iron-man wire
7 F Sheath
23cm long
Puncture site for TAVI Sheath

12. Perclose Skin incision not too short!!
Enlarge the subcutaneous channel with a clamp
10 F Prostar
One Prostar is enough, regardless of sheath size

13. Big Sheath Remove the Perclose over a regular 0.035" wire
Introduce a 10 F sheath
Give heparin only at this time
Exchange for the big sheath over a stiff wire

14. How to introduce the big sheath?
Use dilators with increasing diameter (18+)
Activate the hydrophilic coating by making it wet
Rotate the sheath not more than 20° clockwise/counterclockwise
You may consider to make the sheath more slippery with ….

15. If that does not work Consider Balloon angioplasty of stenoses
Brachial access
snare the wire and pull it up together with the sheath
Implantation of an oversized endograft
Valve implantation a few weeks later

16. Sheath Removal

17. Long 7F sheath from the contra-lateral side
0.035" wire
7 F Sheath
23cm long
7 F Sheath
23cm long
18+ Sheath
Iron-man wire
Long 7F sheath from the contra-lateral side
 cross over (Iron-man still in place)
Have the dilator of the big sheath ready
Remove the wire only when the big sheath is in the common femoral artery
Have PTA balloons and covered stents ready
Remove the big sheath
Intermittent contrast injections to rule out perforation

18. Contrast injection via the 7F sheath or the big sheath
Slowly pull back the big sheath

19. 3 main complications Iliac rupture Occlusion at the puncture site
Bleeding at the puncture site

20. What to do in iliac rupture?
Re-advance the big sheath to stop bleeding!
Introduce an 8-10 mm PTA balloon via the contralateral 7 F sheath to control bleeding
Covered stent via the big sheath or the contra-lateral 7F sheath
Hemoban, Viaban, Fluency, …

21. Iliac rupture  percutaneous repair

22. If there is no iliac rupture
Pull the sheath out
Bring the knots down
Angiogram
Cut the suture
Close the skin

23. … and if there is an occlusion?
 balloon, stent,….

24. What to do if it bleeds? If the 0.035" wire is still in place
You may try to re-introduce the sheath to stop bleeding immediately
Inflate the PTA balloon in the common/external iliac artery
Minor bleeding
Manual compression

25. … major bleeding or if manual compression does not work:
Advance a PTA balloon from the contralateral side into the common femoral artery
Inflate it at the puncture site for 15 min

26. And if prolonged balloon inflation does not work?
Implant a covered stent at the puncture site

27. … or you could call the surgeon

28. If he is a good surgeon … … he will not perform surgery
He will put his finger into the hole …
what he can easily do because you had made a large skin incision
… and stop the bleeding

29. Thank you very much!

32. Back-up

34. Perclose (10F Prostar) Marker channels with sutures
for back bleeding that indicates
proper device positioning
Barrel to pull back
the needles
Stamp

35. Aussendurchmesser einer 18 F Schleuse?
3 D CT Reconstruction

36. Big Sheath at What Time? After crossing the valve!
Before or after valvuloplasty?
Before or after preparing the valve?
To consider
The big sheath in the groin is not healthy
Balloon valvuloplasty may result in severe AR requiring immediate valve implantation
You do not want to prepare the valve before you are sure that you can implant it
Our standard
Crossing the valve  big sheath  valvuloplasty  valve implantation