1. How TAVR Impacts Cardiac Surgery and What the Credentials for the Surgeon Should Be
Joseph E. Bavaria, M.D.
Roberts-Measey Professor and
Vice-Chief of Cardiovascular Surgery
And Howard Herrmann, MD
Professor and Chief, Interventional Cardiology
(CV Service line portion)
CRT Wash DC, Feb. 2013

2. Joseph E. Bavaria, MD Grant Support: Edwards Lifesciences, LLC
Honoraria: Vascutek
Off-Label: Will discuss TEVAR for off-label indications in dissections. Will discuss TAVI which is not approved at this time and is only in trial

3. TAVR Categories in Relation to the AS Universe
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Operable AS patients
Too Sick
Inoperable
High Risk
Low-Intermediate Risk
II A A
High
Risk B
Extreme
Risk C
90%
10%
? 20% 3

4. 50% of the growth in valves is from TAVI
Accelerated slope since initiation of TAVR program
HUP – Valve primary procedure volume

5. Penn Heart Surgery Program FY10
fiscal year, Penn surgeons performed 1,250 valve procedures
Total N = 2400 open Heart

6. Cardiac Surgery and Alternate access

7. TF & TA Utilization Edwards Sapien Valve
Europe TF
50%
Importance of this slide: FDA and Cohort A

8. All-Cause Mortality or Stroke (AT)
34.8%
29.7%
25.7%
∆ at 1 yr:
AVR - PMA-TA = –5.1%
AVR - NRCA-TA = +4.0%
PMA-TA - NRCA-TA = +9.1%
Improvement
No. at Risk
AVR 92 72 67 66 63
PMA-TA
104 81 77 70
NRCA-TA
822
563
365
291
123

9. Actuarial 1-Yr Survival (%)
Canadian Multicenter Experience (TCT 2009)
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
Actuarial 1-Yr Survival (%)
76%
75%
78%
64%
65%
Survival (%)
64%
All patients
Transfemoral
Transapical 6 12 18 24
No. of Months
Patients at risk
339
166 95 39 26
205
129 53 34
162 90 60 28 22
103 73 35 25
177 75 34 11 3
101 55 17 8

10. Impact of Accumulated Transapical Site Experience on Stroke (AT): LOW STROKE RATES!!
∆ = 0.2%
∆ = 0.2%
Sites Initiated Before Sep 2009: 14 Sites
Sites Initiated After Sep 2009: 10 Sites

11. Cardiac Surgery and CV Service line Financial Impact

12. Background
Is AVR Important (Financially) to Cardiovascular Surgery and the Health System?
How Important?

13. Contribution Margin of Various Cardiac Treatments
Valve procedures are highly profitable; generating a healthy average contribution margin and per case gain

14. Example Commercial Patient
OR Supplies, driven by valve 74% of direct cost

15. Example Commercial Patient
OR Supplies, driven by valve 78% of direct cost

16. Aortic Valve Replacement Germany 2000-2010
TAVR =23.9%
2011-~ 5, % !

17. Credentialing and the NCD

18. Transfemoral and Alternate Access Results: Real World, Large Series, Consecutive Cases (n=250)

19. Transcatheter Valve
S. Bleiziffer, et al; (Munich, Germany); JTCVS 2010
N= 250; 82% TF/Retrograde; 85% CoreValve; 15% Sapien, Real World, all pts.included.
Age= 81.4, Euroscore=24.3
Variety of Approaches:
Transfemoral and Trans-iliac
Transapical
Trans-Subclavian
Trans Ascending Aorta

20. Transcatheter Valve 30-day mortality = 12.4% CVA= 5.1% TF= 6.1% TA= 0%
S. Bleiziffer, et al; (Munich, Germany); JTCVS 2010
30-day mortality = 12.4%
CVA= 5.1%
TF= 6.1%
TA= 0%
Pacemaker: 19.7%
Arterial Access Complications needing surgical intervention: 11.7%
THIS IS NOT A TOTALLY BENIGN PROCEDURE!

21. Transcatheter Valve Complications Needing a CV Surgeon:
S. Bleiziffer, et al; (Munich, Germany); JTCVS 2010
Complications Needing a CV Surgeon:
Peripheral Vascular and Dissection: 11.7%
Conversion to open AVR: 0.7% (2.6% in Partner A)
Circulatory Collapse requiring CPB Resucitation: 3%
Pericardial Effusion > 1 cm on TEE: 3.6%
Total = 19%

22. Post Market Europe: Standard Series: Intraoperative Procedural Complications List, Initial 170 cases: Is there a Learning Curve? .... Yes But
Root rupture
malplacement
resuscitation
Pericardial effusion
revalving
Coronary ischemia
PM implantation
vascular complications
Intra-operative only
80% CoreValve and 20% Sapien: General Mix
S Bleiziffer, et al; AATS Boston May 2009 (n=250)

23. Off-label implantation was identified in 67% of patients
40% had one, 19% had two, and 8% had three or more off-label criteria.

24. So ….. For these reasons, CMS (and FDA) “Charged” the “Four” Societies to develop a Guideline or Credentialing document which would contribute to the NCD

25. Training/Credentialing Multidisciplinary Heart Team
Valve Centers
Training/Credentialing
Multidisciplinary Heart Team
National TVT Registry

26. TAVR approved under “coverage with evidence development”
Approved for treatment of severe symptomatic aortic stenosis
FDA approved indication and with an FDA approved device
Two cardiac surgeons approve
Performed in facility with
>50surgical AVR’/year (~400); Cardiac anesthesia
>1000 caths/400PCI/year
Structural requirement (30-50)
>20TAVR/year
Mortality<15% ……. Running 1 year > 60% survival
Stroke and Vascular 30 day <15%
Multidisciplinary Heart Team, Institutional Committment
Institutional: Hybrid Room,
Mandatory National TVT Registry participation

27. ACC, STS, SCAI, AATS (Four Societies) Carl Tommaso and Morton Bolman III (Chairs) Ted Feldman and Joseph Bavaria (Vice-Chairs) (ACCF COI Policy)
Guideline Domains:
Institutional
Interventional Cardiology
Cardiac Surgery
TAVR Program Outcomes (Quality)

28. Institutional
Cath Lab Program with 1000 caths/400 PCI per year
(?) Structural procedures per year, 60% BAV
Active Cardiac Surgery Program with > 50 AVR per year
Two Institutionally based Surgeons (>50% documented time at that Hospital)
10/50 of the AVR must be STS > 6
Mandatory Participation in the National (TVT) Database
Highly Recommended that a “Hybrid OR/Cath Lab” be used
Mandatory Sterile Conditions /Standards
Heart Team Approach (including Cardiac Anesthesia)

29. Surgeon
100 Career AVR or 25 AVR per year (50 past 2 yrs PRIOR to initiation of TAVR program
10 High Risk (STS > 6)
Experience with peripheral CPB
Experience with Retroperitoneal and Iliofemoral Artery exposure
Board Certification

30. Interventionalist
Structural Procedures LIFETIME OR
30 Left sided Structural per year (60% BAV)
Board Certification

31. TAVR Program Quality Parameters
30 day All-Cause mortality < 15%
30 day All-Cause Neuro events (including TIA) < 15%
30 day Major Vascular Complication Rate < 15%
> 90% Institutional follow-up in database
60% 1 year survival rate for Non-op (cohort B/Extreme Risk)
After program up for 2 years …. Running 2-yr average
Maintain EITHER 20 TAVR procedures per year OR 40 over 2 years
National TVT database

32. Bottom Line CMS Charge: Must have some evidence that the Institution and the Physicians: “Have some indication that they have a commitment and organized interest” in Heart valve disease

33. Heart Team is KEY: Weekly Penn Aortic Valve and TAVI Conference
Thank You

34. Thomas Eakins: Gross Clinic (1878@JEFF) and Agnew Clinic (1888@PENN)
Great Progress in 10 years!
Thank You