1. TOTAL AORTIC ARCH REPLACEMENT WITH THORAFLEX HYBRID FROZEN ELEPHANT TRUNK PROSTHESIS: RESULTS OF FIRST 100 PATIENTS
Malakh Shrestha, Heike Krueger, Tim Kaufeld, Erik Beckmann, Nurbol Koigeldiyev, Felix Fleissner, Julia Umminger, Axel Haverich and Andreas Martens.
Hannover Medical School

2. Disclosures
Consultant Vascutek Terumo

3. “Elephant Trunk Technique“
Stage 1
1. Aneurysm:15th March 1982
2. CADA: 28th October 1983
3. AADA: 22nd May 1989
Modifications of the Classical Elephant Trunk
Borst HG et al. Extensive aortic replacement using the ‚elephant trunk prosthesis‘
Thorac Cardiovasc Surg 1983; 31 (1): 37-40

4. The second stage completion is inevitable!
METHODS:
March 1982 to March 2012, 179 patients (112 males, age 56 ± 13years)
(91 aneurysms, 88 dissections (47 acute)).
The second stage completion is inevitable!

5. Is branched graft technique better for total aortic arch replacement?
Ann Thorac Surg Jun;77(6):
Separate grafts or en bloc anastomosis for arch vessels reimplantation to the aortic arch.
Di Eusanio M, Schepens MA, Morshuis WJ, Dossche KM, Kazui T, Ohkura K, Washiyama N, Di Bartolomeo R, Pacini D, Pierangeli A.
Spielvogel 2005

6. Thoraflex Hybrid FET graft
Unstented proximal part & stented distal part
4 ‘fingers’, three for supra-aortic vessels, one for ECC
Stent length: 100 & 150 mm
Unstented & stented part available in different sizes
sewing collar
Radio-opaque markers
Fully Sealed Device, gelatine

7. Delivery System Release Clip Tip Splitter Splittable Sheath
with side guide wire access
Splitter
Splittable Sheath
Completely removed from system after deployment
Malleable Shaft
Handle
Strap
Release Clip

8. Thoraflex Hybrid FET Graft
Plexus 4 Branched graft
Sewing Collar for distal anastmosis
Fully Sealed Device
Radio opaque markers

10. Hannover Concept Core temperature 25°C Bilateral SACP (22-24°C)
‘Beating Heart‘ arch surgery
Minimize lower body ischaemia
CSF drainage
CO2 Sufflation
FET

12. Pre-operative Data All Acute Dissection Chronic Dissection Aneurysm P
All
Acute Dissection
Chronic Dissection
Aneurysm P
Patients (n)
n = 100
n = 37
n = 21
n = 42
Sex (Male (n,%))
n = 65 (65%)
n = 28 (76%)
n = 12 (57%)
n = 25 (60%)
0.226
Age (Years)
59 ± 14
56 ± 13
54 ± 16
64 ± 11
0.004
Marfan Syndrome (n,%)
n = 11 (11%)
n = 4 (11%)
n = 5 (24%)
n = 2 (5%)
0.075
Previous surgery (n,%)
n = 28 (28%)
n = 1 (3%)
n = 15 (71%)
n = 12 (29%)
<0.0001

13. Intra-operative Data All Acute Dissection Chronic Dissection Aneurysm
All
Acute Dissection
Chronic Dissection
Aneurysm P
Patients (n)
n =100
n = 37
n = 21
n = 42
Operation time (min)
367 ± 80
391 ± 62
393 ± 64
334 ± 90
0.001
CPB time (min)
241 ± 61
267 ± 46
244 ± 52
217 ± 68
0.0007
Cardiac ischemia time (min)
123 ± 62
146 ± 56
117 ± 61
105 ± 63
0.011
Distal CA time (min
57 ± 55
60 ± 39
64 ± 34
51 ± 32
0.354
SACP time (min)
98 ± 36
110 ± 35
104 ± 36
84 ± 31
0.003
“Beating Heart” arch repair
n = 47 (47%)
n=14 (38%)
n = 9 (43%)
n = 24 (57%)
0.210
Concomitant procedures:
- Bentall
- Valve sparing root
- CABG
- MVR
- AVR
n = 52 (52%)
n = 10
n = 30
n = 12
n = 3
n = 2
n = 26 (70%)
n = 5
n = 4
n = 1
n = 0
n = 17 (40%)
n = 8
n = 6
n =1
0.019

14. Post-operative Data *1 pt. has permanent Paraplegia
All
Acute Dissection
Chronic Dissection
Aneurysm P
Patients (n)
n = 100
n = 37
n = 21
n = 42
Ventilation (days)
1.0 ( )
2.8 ( )
0.9 ( )
0.7 ( )
0.0019
Rethoracotomy for bleeding (n,%)
n = 16 (16%)
n = 8 (22%)
n = 3 (14%)
n = 5 (12%)
0.487
Stroke (n,%)
n = 10 (10%)
n = 5 (14%)
n = 2 (5%)
0.330
Paraparesis * (n/%)
n = 7 (7%)
n = 3 (8%)
n = 2 (10%)
0.741
Recurrent nerve palsy (n,%)
n = 25 (25%)
n = 9 (24%)
n = 8 (38%)
n = 8 (19%)
0.256
Renal failure; dialysis ** (n,%)
n = 14 (14%)
n = 4 (11%)
n = 4 (19%)
n = 6 (14%)
0.684
30 day mortality (n,%)
n = 1 (5%)
n = 3 (7%)
0.890
*1 pt. has permanent Paraplegia
** 1 pt. needs permanent Dialysis

15. Distal aortic reinterventions
All
Acute Dissection
Chronic Dissection
Aneurysm P
Patients (n)
n = 100
n = 37
n = 21
n = 42
Second procedure downstream aorta (n,%)
n = 20 (20%)
n = 2 (3%)
n = 7 (33%)
n = 11 (26%)
0.016
Time to reoperation (months)
7.0 ( )
6.8 ( )
9.2 (6.9-11)
5.3 ( )
0.295
- open surgical
- thoraco-abdominal
- descending aorta
- abdominal/iliac
- endo-vascular
n = 7 (7%)
n = 2
n = 3
n = 13 (13%)
n = 0 (0%)
n = 0
n = 2 (5%)
n = 3 (14%)
n = 1
n = 4 (19%)
n = 4 (10%)
n = 7 (17%)
0.086
0.216

16. Aortic imaging
Segment A
Segment B
Segment C

17. Aortic remodeling: False lumen thrombosis in AADA
Pre-OP
Post-OP
Last Follow Up
Patent
Partial
Thromb.
P vs. Pre
Segment A
22 (85%)
1 (4%)
3 (12%)
4 (16%)
20 (80%)
<0.001
1 (6%)
2 (11%)
15 (83%)
Segment B
21 (84%)
10 (41%)
8 (33%)
6 (25%)
0.006
5 (31%)
16 (38%)
Segment C
0 (0%)
14 (58%)
4 (17%)
0.056
11 (69%)
4 (25%)
0.3233

18. Aortic remodeling in AADA
Aortic diameters
Post-OP vs. Pre-OP
Last Follow Up vs. Pre-OP
Aortic diameter difference (%, P)
Aortic diameter difference (%,P) AL TL FL
Segment A
+0.0%
(0.506)
+66%
(0.001)
-32%
(0.0001)
-3.0%
(0.179)
+92
(<0.0001)
-68%
Segment B
+0.5%
(0.854)
+53%
(0.015)
-23%
(0.020)
+31%
(0.704)
+60%
(0.005)
-13%
(0.023)
Segment C
+3.3%
(0.267)
+43%
(0.104)
-26%
(0.066)
+8.5%
(0.331)
+44%
(0.051)
-8.2%
(0.330)

19. Aortic remodeling: False lumen thrombosis in CAD
Pre-OP
Post-OP
Last Follow Up
Patent
Partial
Thromb.
P vs. Pre
Segment A
15 (71%)
1 (5%)
5 (24%)
4 (20%)
6 (30%)
10 (50%)
0.003
3 (18%)
5 (29%)
9 (53%)
Segment B
15 (75%)
2 (10%)
3 (15%)
14 (74%)
3 (16%)
2 (11%)
0.815
15 (94%)
1 (6%)
0 (0%)
0.232
Segment C
16 (89%)
14 (82%)
2 (12%)
0.295
12 (92%)
1 (8%)
0.242

20. Aortic remodeling in CAD
Aortic diameters
Post-OP vs. Pre-OP
Last Follow Up vs. Pre-OP
Aortic diameter difference (%, P)
Aortic diameter difference (%,P) AL TL FL
Segment A
-4.7 %
(0.454)
+45 %
(0.100)
-19 %
(0.049)
-14 %
(0.133)
+77 %
(0.003)
-31 %
(0.001)
Segment B
-3.3 %
(0.560)
+15 %
(0.500)
-11 %
(0.227)
-0.6 %
(0.967)
+25 %
(0.668)
-2.6 %
(0.528)
Segment C
-2.4 %
(0.673)
+9.4 %
(0.718)
-10 %
(0.452)
-0.8 %
(0.725)
+1.2 %
+2 %
(0.676)

21. Kaplan Meier Curve: Freedom from Re-intervention

22. Kaplan Meier Curve: Survival

23. Conclusion The Thoraflex Hybrid FET:
1. Combines advantages of FET and Plexus arch graft
2. Ease of FET delivery
3. Unique features , e.g. “Sewing Collar“
4. Aortic “remodelling“ in Aortic dissections
5. Potentially „single stage“ therapy in Aneurysms
6. Excellent peri-operative and mid-term results.
‘Beating Heart’ in Aortic Arch Surgery
1983
1988
1991/93
1997/2003
2004
2006
2013
Borst
Svensson
Kazui
Usui, Karck
Neri
‘Siena graft‘
Shrestha, Haverich

24. Thank You!
“The Aortic Team“ Hannover Medical School!