1. Columbia University Medical Center Cardiovascular Research Foundation
Will Vascular Complications Remain the Achilles’ Heel of Transfemoral TAVI? – Cardiology View
Martin B. Leon, MD
Columbia University Medical Center
Cardiovascular Research Foundation
New York City
CRT 2011; Washington DC
February 27- March 1, 2011

2. Presenter Disclosure Information for CRT Symposium; February 28, 2011
Martin B. Leon, M.D.
NON-PAID Consultant:
Edwards Lifesciences, Medtronic
Consultant:
Symetis
Equity Relationship:
Claret, Sadra, Vivasure

3. Vascular Complications - TAVI
Background

4. REVIVE & REVIVAL Vascular Complications (15.5%)
Perforations (n=12)
Covered Stent - 3
3 Deaths
Surgical Bypass - 9
Flow Limiting Iliac Dissection (n=4)
2 Deaths
Surgical Repair - 4
In Hospital Mortality in Patients with a Vascular Complication – 36%
In Hospital Mortality in Patients without a Vascular Complication – 10.3%
Vascular Complications (n=25)
Avulsed Iliac Artery (n=3)
Surgical Bypass - 3
Aortic Dissection (n=3)
Surgery - 1
2 Deaths
Medical - 2
Lower Extremity Ischemia (n=4)
Surgery - 2
2 Deaths
Medical - 2 3 3

5. Edwards TAVI Complications Multiple Data Sources (TA and TF)
POOLED*
(503 pts)
SOURCE (1038 pts)
VANCOUVER (250 pts)
PARIS (75 pts)
CA-Multictr (339 pts)
Vascular (maj)** (%)
18.5
10.6
10.3
11.8
13.1
AR >2+ (%)
10.9
4.7
5.0
5.3
7.7
Stroke (%)
4.0
2.5
3.0
2.3
New Pacemaker (%)
4.4
7.0
5.5
4.9
Renal Failure (%)
5.2
8.7
4.2 na
2.6
Coronary Obstr (%)
0.6
* REVIVE, REVIVAL, TRAVERCE, PARTNER EU
** TF Only

6. SOURCE Vascular Complications 1-Year Survival (22/24F Device)
Approach
% Survival in Pts who did not have vascular complications
% Survival in Pts who did have vascular complications
P-Value TF
83.9%
72.2%
0.0121
Without Vascular Complication
With Vascular Complication
Survival
Months post Procedure
1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0 1 2 3 4 5 6 7 8 9 10 11 12
Trans-femoral (463 pts) 5 5

7. Published on-line September 22, 2010 @ NEJM
Published on-line September 22, NEJM.org and print October 21, 2010
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On behalf of the Executive Committee, the Investigator Sites,
and the courageous patients who participated in the PARTNER trial! 6

8. VARC Definitions J Am Coll Cardiol 2011; 67:253-69
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J Am Coll Cardiol 2011; 67:253-69 7

9. Clinical Outcomes at 30 Days and 1 Year
Vascular Complications
Major
All
P<0.0001
P<0.0001
per cent
P<0.0001
P<0.0001
TAVI (n=179)
Standard Rx (n=179)

10. Mortality vs. Major Vasc Complics TAVI patients
Major Vascular Complication (n=31)
No Major Vascular Complication (n=148)
P (log rank) = 0.069
47.2%
Mortality (%)
27.7%
Months 9

11. Vascular Complications - TAVI
Solutions

12. Vascular Complications - TAVI Solutions
Smaller profile sheaths (and new expandable sheath systems)

13. Edwards TAVI Sheaths Delivery Systems are Improving
24F 22F 18F

14. Vascular Complications - TAVI Solutions
Smaller profile sheaths (and new expandable sheath systems)
Meticulous vascular screening and team training

15. TAVI Vascular Access Screening
All patients - angiogram and CTA or IVUS/non-contrast CT if renal function a concern.
Contrast requiring procedures are separated
Diagnostic cath performed non-Rx side
Studies carefully reviewed by entire team with focus on vessel size, tortuousity, pathology and calcification (especially at bifurcations)

16. TAVI Vascular Access Assessment (trans-femoral)
Vessel Size
Determined with CTA or IVUS
Avoid use of angiogram as sole method
Tortuosity
Determined with angiogram
During diagnostic place stiff wire to determine ability of artery to ‘straighten’
Calcification
Determine with non-contrast, non-subtracted cine and non-contrast CT
Greatest concern is circumferential calcification at bifurcations (location is critical)
Lesions
Severity, focal vs. diffuse, +/- calcified, location

17. REVIVE improved screening to reduce vascular complications
Vascular Access Complication Rate, by patient
January 2006 – June 2006
30%
Vascular Access Complication Rate, by patient
August 2006 – December 2007
5.8%
Vascular Screening with
Columbia University
Medical Center
Core Lab
INSTITUTED
(in coordination with DSMB)
P = .006 16 16

18. Vascular Complications - TAVI Solutions
Smaller profile sheaths (and new expandable sheath systems)
Meticulous vascular screening and team training
Liberal use of alternative vascular access sites (don’t push the envelope)

19. TAVI Vascular Access Sites
Trans - femoral
Most common; limited by local anatomy/pathology
Only percutaneous access and closure site
Trans - apical
Mini-thoracotomy; requires more training
Trans - subclavian/axillary
Alternative if femoral inaccessible
Trans - iliac/abdominal aorta
Retro-peritoneal surgical access + conduit
Trans - thoracic aorta
Mini-thoracotomy alternative
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20. Vascular Complications - TAVI Solutions
Smaller profile sheaths (and new expandable sheath systems)
Meticulous vascular screening and team training
Liberal use of alternative vascular access sites (don’t push the envelope)
Percutaneous access and closure (and new dedicated closure devices in the future)

21. TAVI Vascular Closure Techniques (trans-femoral) PERCUTANEOUS CLOSURE – Why?
Simplifies the procedure and facilitates use of conscious sedation
Improves patient comfort and facilitates early ambulation (and discharge)
Becomes comprehensive interventional non-surgical procedure – less dependence on OR environment, anesthesia, and surgeons

22. TAVI Vascular Closure Techniques (trans-femoral) PERCUTANEOUS CLOSURE
Suture mediated
One Prostar
Two (or three) Proglides
Other devices under development

23. Columbia CBOT after TAVI58
Transfemoral TAVIs
(November 2008 to September 2010)
Columbia CBOT
after TAVI 2
Elective Surgical Repairs
(Vessel unsuitable for percutaneous closure) 56
Percutaneous closure with CBOT
95%
Success
Rate
3 (5.4%)
Failed closure/Bridge to Surgical Repair
1 occlusive dissection of external iliac
2 perforation of external iliac
53 (94.6%)
Successful Closures
24 (42.8%)
Primary Closure
29 (51.8%)
Therapeutic CBOTs
26 (46.4%)
Post-dilatation Balloon only
3 (5.4%)
Endovascular Stent

24. Vascular Complications - TAVI An Ongoing Achilles’ Heel?
As with most things in interventional cardiology, the combination of 1) improved technology (lower profiles and dedicated closure devices), 2) meticulous training, screening and procedure planning, and 3) evolving operator experience – will significantly reduce the frequency and severity of TAVI-related vascular complications, maintaining the transfemoral approach as the dominant access strategy in the future!