1. The Impact of Live Case Transmission on Patient Outcomes during Transcatheter Aortic Valve Replacement: Results from the VERITAS Study Dr. Ron Waksman On behalf of the VERITAS Investigators

2. Disclosures
FDA provided partial grant support

3. Ron Waksman, MD Consulting: Biotronik, Inc. Abbott Laboratories
Boston Scientific Corporation
Medtronic, Inc.
Merck and Company, Inc.
Honoraria:
Abbott Laboratories,

4. Background
Live case demonstrations presenting cutting-edge technology during interventional cardiology meetings have been performed for over 30 years and are considered a valuable educational resource.
There is an ongoing discussion on whether patients who are treated during live case demonstrations are exposed to a higher risk.
Currently there is no safety data on live TAVR cases and the Valve Devices under IDE are not allowed to be broadcast.

5. VERITAS Trial Objectives
VERITAS: (Transcatheter Aortic Valve IntERvention-LIve Case TrAnsmiSsion)
Objective:
Assess the safety of patients treated with TAVR during a live case or video-taped transmission as compared to those treated with TAVR without live or recorded transmission.
Hypothesis:
The rate of major complication within the live case or video-taped transmission TAVR patients will be similar to those treated without a transmission.

6. VERITAS Study Safety Endpoints
Safety assessed by the rates of major complication defined as the composite of:
In-hospital death
Stroke, post procedural
Tamponade
Valve embolization
Coronary obstruction
Renal failure requiring dialysis
Need for pacemaker
Infection
VARC In-hospital Outcomes

7. VERITAS Study Procedural Safety Endpoints
Procedure time
Fluoroscopy time (minutes)
Intubation time (if performed)
Amount of contrast use (cc)
Length of stay in intensive/coronary care units
Length of hospital stay
Development of myocardial infarction (MI)
Respiratory or heart failure requiring mechanical ventilation
Device migration, need for a second valve
Need for open heart surgery
Need for unplanned cardiopulmonary bypass
Major vascular complications including
Access site complication requiring open repair
Distal embolization requiring surgery

8. VERITAS Trial Design Case-Control Study TAVR
Matched Control : NOT Live transmission or taped TAVR
42 Enrolled
Matched Case:
Live transmission or taped TAVR
42 Enrolled
Registry Case:
Live transmission or taped TAVR
18 Enrolled
Matching Criteria
Site and operator
STS Score ± 2 points
Date of the TAVR procedure ± 4 weeks
First attending for the TAVR procedure
Access site/valve for TAVR
Inclusion Criteria:
Subject > 18 years of age
Subject underwent TAVR procedure with:
Edwards-Sapien transfemoral approach
Edwards-Sapien transapical approach
CoreValve transfemoral approach

9. Methodology
Sites conducted a retrospective chart review to collect data for all Case and Control subjects as appropriate per Ethics Committee guidelines.
Only de-identified information collected on these subjects.
The sites matched the control subject to the case subject by the specified criteria.
Site and operator
First attending for the TAVR
STS Score ± 2 points
Access site/valve for TAVR
Date of the TAVR (± 4 weeks)

10. Principal Investigator Case Registry Subjects
VERITAS Study Sites
Site
Principal Investigator
Matched Pairs
Case Registry Subjects
Guys and St Thomas' Hospital
London, United Kingdom
Martyn Thomas, MD 13 8
Bern University Hospital
Bern, Switzerland
Steffen Gloekler, MD 10
CardioVasculares Centrum Frankfurt
Frankfurt, Germany
Horst Sievert, MD 4
Saint Paul's Hospital
Vancouver, Canada
John Webb, MD 7
San Raffaele Hospital
Milan, Italy
Antonio Colombo, MD 6
MedStar Washington Hospital Center
Washington, DC, USA
Ron Waksman, MD 2
Total 42 18

11. Demographics & Medical History
Case
(n=42)
Control
P value
Case Registry (n=18)
Age
84.19 ± 6.77
82.21 ± 8.44
0.240
76.8 ± 10.7
Males
54.8%
38.1%
0.189
55.6%
Caucasian Race
92.7%
88.1%
0.713
100%
Diabetes
20.0%
16.7%
0.917
33.3%
Hypertension
70.7%
66.7%
0.871
Hypercholesterolemia
56.1%
39.0%
0.185
61.1%
Renal Insufficiency
32.5%
23.8%
0.529
22.2%
COPD
19.5%
11.9%
0.515
11.1%
Congestive Heart Failure
92.9%
97.6%
0.616
NYHA Class III or IV
67.6%
68.3%
0.862
72.2%
Endocarditis 0%
2.4%
1.000
0.0%
Current tobacco use
2.5%
14.3%
Prior Balloon Aortic Valvuloplasty
9.5%
0.142
27.8%
Logistic EuroScore
20.64 ± 11.88
20.57 ± 13.68
0.979
16.9 ± 11.7
STS Risk Score
6.54 ± 3.22
6.46 ± 3.20
0.911
4.9 ± 2.9

12. Risk Factors Case (n=42) Control P value Case Registry (n=18)
Coronary Artery Disease
51.9%
40.0%
0.563
3 vessel CAD
25.9%
12.0%
0.296
20.0%
Prior Revascularization
40.5%
26.2%
0.247
47.1%
Prior Myocardial Infarction
11.9%
0.164
16.7%
Peripheral Vascular Disease
7.3%
7.1%
1.000
22.2%
Cerebrovascular Disease
2.4%
0.616
11.1%
Stroke or TIA
21.4%
0.015
Surgical Candidate
38.1%
39.0%
0.810
70.6%
Permanent Pacemaker
12.8%
15.0%
0.964
44.4%
Current Arrhythmia
57.9%
45.9%
0.421
27.8%
Atrial fibrillation
34.2%
35.1%
LBBB
7.9%
10. 8%
0.711
5.6%
RBBB
13.2% 0%
0.543
0.0%
1º AV Block
10.5%
10.8%

13. Baseline Echo Case (n=42) Control P value Case Registry (n=18)
Mean Systolic PA Pressure (mmHg)
51.8 ± 22.3
35.0 ± 7.0
0.100
N/A
Mean AV Gradient (mmHg)
42.4 ± 18.5
48.5 ± 18.0
0.140
± 18.7
Peak AV Gradient (mmHg)
68.5 ± 28.9
73.7 ± 22.7
0.400
86.1 ± 32.4
AV Area (cm2)
0.7 ± 0.2
1.0 ± 1.6
0.390
0.7 ± 0.2
Aorta Diameter (cm)
3.0 ± 0.6
0.790
3.2 ± 0.6
Aortic Annulus
Dilated
0.0%
2.4%
1.000
11.1%
Calcified
63.2%
61.0%
0.974
66.7%
Bioprosthesis
10.5%
9.8%
Sessile or Mobile Aortic Atheroma (>5 mm)
33.3%
25.0%
0.696
Moderate or Severe Aortic Stenosis
92.5%
90.5%
100%
Moderate or Severe Mitral Stenosis
2.7%
0.481
5.6%
Aortic Regurgitation +1
35.0%
34.1%
22.2% +2
30.0%
26.8%
0.966
27.8% +3
5.0% +4
4.9%
Left Ventricular Ejection Fraction
56.8 ± 12.3
52.1 ± 14.3
0.110
55.8 ± 19.0

14. Procedure Case (n=42) Control P value Case Registry (n=18)
Femoral Access
90.0%
92.9%
0.834
72.2%
Ventricular Apex Access
7.5%
7.1%
27.8%
Adjunctive PCI
0.0%
4.8%
0.494
5.9%
Valve Type
Edwards
69.0%
73.8%
0.810
61.1%
Core Valve
31.0%
28.2%
38.9%
Rapid pacing used
78.6%
81.0%
1.000
Need for Second Valve
9.5%
2.4%
0.360
5.6%
Initial Valve Retrieved
Valve Deployment Success
100%
---
Final Valve Correct Positioning
91.2%
97.0%
0.614
94.4%
Delivery Catheter Retrieval Success
Access Site Closure
Surgical, Any
32.5%
35.0%
35.3%
Surgical, Transfemoral
0.829
15.4%
Closure Device, Transfemoral
71.8%
84.6%

15. Bioprosthetic Valve Types

16. Post Procedure Echo Case (n=42) Control P value Case Registry (n=18)
Mean Systolic PA Pressure
53.2 ± 20.4
44.7 ± 14.0
0.420
46.0 ± 6.9
Delta Mean AV Gradient
-30.6 ± 19.5
-34.9 ± 16.3
0.316
-37.4 ± 19.9
AV Area
1.6 ± 0.5
1.4 ± 0.4
0.141
1.4 ± 0.2
Delta AV Area
+0.7 ± 0.5
+0.9 ± 0.6
0.325
+0.6 ± 0.2
Aorta Diameter (cm)
3.0 ± 0.5
3.0 ± 0.6
0.717
3.0 ± 0.4
Moderate or Severe Aortic Stenosis
0.0%
---
Moderate or Severe Mitral Stenosis
5.9%
0.239
Aortic Regurgitation +1
43.5%
52.6%
52.9% +2
28.2%
7.9%
0.067
29.4% +3
5.1%
10.5% +4 0%
Left Ventricular Ejection Fraction
54.1 ± 10.5
54.9 ± 9.7
0.697
50.4 ± 12.3

17. Intraprocedural Complications
* Defined as +3 or +4

18. VARC Complications
Death: p=1.000; Cardiac Death: p=1.000; Tamponade: p=0.494; AKI 3: p=1.000; Post MI: p=1.000; Conversion to Open Heart: p=1.000; Unplanned CPB: p=1.000; End organ failure: p=1.000

19. VARC Vascular Complications and Bleeding

20. Additional Post Procedural Outcomes
All p = NS

21. Key Procedural Variables
Case
(n=42)
Control
P value
Case-Registry
(n=18)
Number of Operators
3.2 ± 1.7
2.9 ± 1.4
0.443
2.3 ± 0.46
More than 3 Operators
21.4%
22.0%
0.835
0.0%
General Anesthesia Usage
76.2%
54.8%
0.066
61.1%
Intubation time (minutes)
4.7 ± 4.6
14.8 ± 40.7
0.200
5.6 ± 4.7
Procedure time (minutes)
130.2 ± 50.6
100.6 ± 43.7
0.006
98.8 ± 41.0
Fluoroscopy time (minutes)
21.0 ± 13.2
20.9 ± 16.5
0.986
16.9 ± 10.9
Amount of contrast use (cc)
180.4 ± 104.2
161.2 ± 76.3
0.358
156.3 ± 82.9
Length of stay in ICU (days)
3.6 ± 4.2
2.6 ± 2.2
0.177
1.3 ± 1.8
Length of hospital stay (days)
10.5 ± 5.7
10.4 ± 6.3
0.957
10.3 ± 8.1

22. Limitations Retrospective data collection Sample size is small
18 case were unable to be matched to controls
Due to the study design, patient satisfaction was not attainable

23. Summary
Although the STS and EuroScore assessments were similar between the case and control patients, there is a suggestions that the live- or taped-transmission patients were slightly more complicated, but statistical significance was not reached.
These results suggest that broadcasting TAVR live case demonstrations in selected patients from selected centers is safe and associated with similar complication rates, fluoro times, contrast volume and length of stay.

24. Conclusions
These data support that TAVR procedures when done by operators who perform high volumes of cases for both live case transmissions in general and TAVR procedures such procedures are safe and similar with respect to events as non-transmitted cases.
Such transmissions, however, should be performed by experienced and high volume operators.
Live- or taped-transmission of TAVR procedures should be utilized for the introduction of the technology and for initial training of the procedural techniques.
To ensure the adequate exposure to new techniques and devices for the TAVR procedure, Live case transmission of investigational devices should be utilized more frequently within the IDE studies to ensure transparency of new device techniques.