1. after Isolated Rapid Deployment Aortic Valve Replacement
Comparison of Procedural Outcomes and Early Safety by Surgical Approach
after Isolated Rapid Deployment Aortic Valve Replacement
Thorsten C.W. Wahlers, M.D., Ph.D.,1 Axel Haverich, M.D.,2 Michael A. Borger, M.D., Ph.D.3 Malakh Shrestha, M.B.B.S, Ph.D.,2 Alfred A. Kocher, M.D.,4 Thomas Walther, M.D., Ph.D.,5 Matthias Roth, M.D.,5 Martin Misfeld, M.D.,3 Friedrich W. Mohr, M.D., Ph.D.,3 Joerg Kempfert, M.D.,5 Pascal M. Dohmen, M.D., Ph.D.,6 Christoph Schmitz, M.D.,7 Parwis Rahmanian, M.D.,1 Dominik Wiedemann, M.D.,4 Francis G Duhay, M.D.,8 Günther Laufer, M.D.4
1Medical University of Cologne, Cologne, Germany, 2Medical University of Hannover, Hannover, Germany, 3Heart Center Leipzig, Leipzig, Germany, 4Medical University of Vienna, Vienna, Austria, 5Kerckhoff Klinik, Bad Nauheim, Germany, 6University of Leipzig, Leipzig, Germany, 7University of Munich, Munich, Germany, 8Edwards Lifesciences LLC, Irvine, CA, USA

2. Background
Aortic valve replacement through a minimal access approach is associated with favorable clinical outcomes1-3
However, several meta-analyses have reported significantly longer cross-clamp times compared to a full sternotomy1, 4
References
1. Brown et al., J Thorac Cardiovasc Surg. 2009;137: e5.
2. Machler et al. Ann Thorac Surg. 1999;67:
3. Albacker et al. J Thorac Cardiovasc Surg. 2014;147: e5.
4. Phan K, et al., Ann Thorac Surg. 2014;98:

3. Purpose
In patients enrolled in the TRITON trial, we examined procedural and early (<30 days) safety outcomes after isolated rapid deployment aortic valve replacement through
Full Sternotomy
Upper Hemisternotomy
Right Anterior Thoracotomy

4. Methods Prospective, multicenter single arm study
(Hannover, Cologne, Leipzig, Vienna, Bad Nauheim, Munich)
287 patients with symptomatic, severe aortic stenosis underwent RDAVR using the EDWARDS INTUITY Valve System
Inclusion criteria: age ≥ 18 yrs; AS ± AR; elective AVR ± concomitant procedure(s); informed consent; agree to f/u for 5 yrs
Exclusion criteria: Pure AR; concomitant valve disease, or aneurysm of aortic root or ascending aorta requiring surgery; life-expectancy < 12 mos
Patients were operated between January 2010 & October 2012
For the purposes of this study, patients were evaluated for:
Perioperatively, for procedural times and technical success rates
At discharge, for hospital length of stay
At 30 days, for early adverse events

5. EDWARDS INTUITY Overview
A rapid deployment technique that incorporates a subannular, balloon-expandable stent frame that mechanically widens the LVOT to ensure a larger EOA compared to conventional surgical valves

6. Triton Study Overview Technical Success 96.1% 98.6% 97.3% Enrollment
Gen I Valve
n=149
Gen II Valve
n=138
Combined
n=287
Technical Success
(Deployment of the study valve within two attempts)
96.1%
(149/155)
98.6%
(138/140)
97.3%
(287/295)

7. Surgical Approach Overview
Number of Cases by Surgical Approach
Enrollment
n=295
158 (55%)
Isolated AVR
71 (45%)
Full Sternotomy
87 (55%)
Minimal Access Incision
77 (89%)
Upper Hemisternotomy
10 (11%)
Right Anterior Thoracotomy

8. Results: Baseline Characteristics
Enrollment
n=295
Technical Success
FS % (71/73)
UHS % (77/79)
RAT -100% (10/10)
Isolated RDAVR
n=158
Delivery and deployment of the study valve within two attempts
Parameter
Full Sternotomy (n=71)
Upper Hemisternotomy (n=77)
Right Anterior Thoracatomy
(n=10)
Age,yrs
75.7 ± 6.8
75.6 ± 6.6
75.3 ± 13.5
FEMALE
49.3 % (35/71)
50.6 % (39/77)
60.0 % (6/10)
Logistic EuroSCORE, %
8.0 ± 6.4
7.9 ± 4.9
12.0 ± 14.8
Body Mass Index, kg/m2
28.7 ± 4.2
27.8 ± 4.4
25.7 ± 3.4
Body Surface Area, m2
2.0 ± 0.2
1.9 ± 0.2
LVEF, %
63 ± 11
58 ± 13
59 ± 8
TRITON Database as of 17-June-2014

9. Results: Distribution of Valve Sizes
mean 23.3 mm
mean 23.6 mm
TRITON Database as of 17-June-2014

10. Results: Early Safety Outcomes
Parameter
Full Sternotomy
Upper Hemisternotomy
Right Anterior Thoracatomy
All Cause Mortality
1.4% (1/71)
1.3% (1/77)
0.0% (0/10)
Study Valve Related Mortality
Reoperation for Bleeding
7.0% (5/71)
7.8% (6/77)
Renal Failure/Dysfunction
2.8% (2/71)
9.1% (7/77)
Thromboembolic Event
Deep Sternal Wound Infection
Respiratory Dysfunction
3.9% (3/77)
Major Bleeding Events
11.3% (8/71)
6.5% (5/77)
Study Valve Related Explant
PVL Requiring Surgical Intervention
0.0% (0/71)
Pacemaker Implants,Total
5.6% (4/71)
5.2% (4/77)
Valve Related Pacemaker Implants
4.2% (3/71)
2.6% (2/77)
TRITON Database as of 17-June-2014

11. Results: Procedural Times
Parameter
FS (n=71)
UHS (n=77)
RAT (n=10)
p-value FS vs. UHS
p-value FS vs. RAT
Cardiopulmonary by-pass time (min)
71.6±41.8
69.6±19.1
122.2±22.1
0.2639
<.0001
Cross-clamp time (min)
43.5±32.5
43.1±13.1
88.3±18.6
0.1306
FS, full sternotomy; UHS, upper hemisternotomy; RAT, right anterior thoracatomy
TRITON Database as of 17-June-2014

12. Results: Procedural Times II
Comparison of Cross-clamp times to the Literature
EDWARDS INTUITY
Upper Hemisternotomy
REFERENCE
CROSS-CLAMP TIME (MIN)
TRITON 43
Borger1 41
Schlomicher2 26
Overall
26 – 43 min
Surgical Valves
Upper Hemisternotomy
REFERENCE
CROSS-CLAMP TIME (MIN)
Tabata1 72
Bakir2 62
Brinkmann3 75
Overall
62 – 75 min
Borger et al. Ann Thorac Surg. 2015;99:17-25.
Schlomicher et al. J Thorac Cardiovasc Surg Feb;149(2):
Tabata et al. Asian cardiovascular & thoracic annals. 2007;15:225-8.
Bakir et al. Ann Thorac Surg May;81(5):
Brinkman et al. Ann Thorac Surg. 2010;90:131-5.
TRITON Database as of 17-June-2014

13. Results: Discharge Outcomes
Parameter
FS (n=69)
mean ± sd (min, max) median
UHS (n=76)
RAT (n=10)
P-value
FS vs. UHS
FS vs. RAT
Hospital LOS (days)
11.7±6.3 (6.0, 50.0)10.0
13.1±10.6 (5.0, 89.0)10.0
9.5±6.7 (5.0, 28.0)7.0
0.8189
0.0116
ICU LOS (hours)
61.7±115.4
(0.0, 664.0)24.0
59.1± (0.0, 625.0)23.0
33.6±12.4 (24.0, 48.0)24.0
0.0936
0.5658
Intermediate Care LOS (hours)
22.3±45.1 (0.0, 192.0)0.0
43.7±92.8 (0.0, 504.0)0.0
19.2±42.0 (0.0, 120.0)0.0
0.1258
0.5940
In-hospital mortality
2.8% (2/71)
1.3% (1/77)
0.0% (0/10)
0.6076*
0.9999*
P-values based on Wilcoxon
* indicates use of Fisher's Exact test to calculate the P-values
LOS, length of stay; FS, full sternotomy; UHS, upper hemisternotomy; RAT, right anterior thoracatomy
TRITON Database as of 17-June-2014

14. Reoperation 19 mm Valve degenerated 21 mm Intuity Valve, 44 Min
Reoperation 19 mm Valve degenerated 21 mm Intuity Valve, 44 Min. Clamptime

15. Conclusions
Isolated RDAVR through an upper hemisternotomy can lead to shorter cross-clamp times than than have been historically reported in the surgical literature
This benefit may facilitate minimally invasive AVR by lessening the concern over prolonged cross-clamp times
Regardless of surgical approach, isolated RDAVR with EDWARDS INTUITY may lead to…
Low in-hospital mortality rate
Low early (<30 days) mortality rate
Low new permanent pacemaker implant rate

16. Limitations
TRITON represents initial experience using EDWARDS INTUITY Valve System; hence, incorporates learning curve
Lack of active comparator group

17. Thank you for the attention.