The document summarizes the expanding clinical applications of endovascular aneurysm repair (TEVAR) beyond its original use for descending thoracic aneurysms. It discusses how TEVAR is now being used to treat a wider range of thoracic aortic pathologies including dissections, ulcers, trauma, and various complex aneurysms. The document also explores new techniques like branched endografts and debranching procedures that are pushing the anatomic limits of TEVAR proximally and distally. While noting some limitations, it presents data showing TEVAR has led to reduced mortality, complications, and hospital stay compared to open surgery for many thoracic aortic conditions.

1. The Expanding Clinical Applications of
TEVAR
Michel Makaroun MD
Co-Director UPMC Heart and Vascular Institute
Professor and Chief, Division of Vascular Surgery
University of Pittsburgh School of Medicine

2. Disclosures
Consultant:
WL Gore, Cordis, Medtronic
Research Grants:
WL Gore, Cook, Cordis
Medtronic, Boston Scientific, Abbott
Bolton, Lombard, Trivascular

3. March 2005:TAG was the 1st
device approved in the US
for the Rx of Descending Thoracic Aneurysms
More Devices + Modifications were approved since:
TX2 (Cook)
Talent and Valiant (Medtronic)
C-TAG (WL Gore)
Relay (Bolton)
With more to come !!

4.  WL Gore
Gore TAG device Approval 2005
 C-TAG Approval 2011 (Trauma 2012 / Dissection 2013)
 Medtronic
Talent device Approval 2008
Valiant Device Approval 2011
 Cook Inc.
TX2 device Approval 2008
 Bolton
Relay Approval 2012
Investigational Devices
 Enrolment in progress Cook TX2 LP (Low profile)
Current Devices in the US approved for DTA

5.  Requires Thoracotomy
 Single lung ventilation
 Heart bypass in many cases
Open Repair of DTA

6. N Mortality Renal Failure Paraplegia
Coselli 2004 387 2.8% 7.4% 2.6%
Estrera 2001 182 8.8% 2.7%
Galloway 1996 78 10.3% 3.8%
Verdant 1995 366 12% 2.4% 0%
Livesay 1985 360 11.7% 6% 6.5%
Svensson 1993 782 4.9%
Total 2155 8.8% 5.3% 3.7%
Results of Open Repair of DTA

7. Procedural Events
Technical success 98% 98.8% 99.5% N/A 87%
EBL 250 ml 216 ml 371 ml 2067 ml -
Hospital stay 3.0 days 5.0 days 6.4 days 15 days -
30 Day outcomes
Mortality 1.5% 1.9% 2.1% 7.1 % 5.3%
Spinal cord ischemia 2.8% 5.6% 8.7% 13% 4%
Stroke 3.5% 2.5% 3.6% 6.7% 2.8%
MAE 28% 41.9% 30% 77% -
STUDY
&
STENT GRAFT
TAG STARZ VALOR TX2+TA
G Control
Open
Repair
EUROSTAR+
UK
TAG TX2 TALENT Multiple
TEVAR Results vs Open Repair

8. J Vasc Surg 2008;47:912-8

9. Endo Open
Years Since Treatment
0 1 2 3 4 5
Survival
1.0
0.8
0.6
0.4
0.2
0.0
Log Rank P = 0.01
FIVE YEAR FOLLOW-UP: Aneurysm Related Survival

10. All Cause Mortality
Endo Open
Years Since Treatment
0 1 2 3 4 5
Survival
1.0
0.8
0.6
0.4
0.2
0.0
Log Rank P = 0.40

11. Freedom from Re-Interventions
Years Since Treatment
0 1 2 3 4 5
FreedomfromReintervention
1.0
0.8
0.6
0.4
0.2
0.0
Log Rank P = 0.01
Endo Open

12. J Vasc Surg 2013;58:346-54

13. J Vasc Surg 2013;58:346-54
Open TEVAR
Mortality 12% 5.2%
Any Complication 50% 30%
Renal failure 19% 6.6%
Cardiac 13% 4.9%
Pulmonary 23% 7.4%

14. J Vasc Surg 2006;43A:20-21
By 2005
36% of Worldwide
TEVAR use was for
OTHER
Non Descending
Thoracic Aneurysm
(DTA) applications

15. Ann Thorac Surg 2013;95:1577-83
Vienna Single center series
 1996-2010
 300 patients
 137 descending thoracic aneurysms 46%
 80 Type B dissections (60 acute) 26%
 59 perforating aortic ulcers 20%
 24 traumatic transections 8%

16. The Clinical Applications of TEVAR has clearly
been expanding beyond the original target of
Thoracic Endografts:
Expanding anatomic limits both proximally and distally:
Hybrid Debranching, Chimneys and Branched Endografts
Expanding Indications and Pathologies treated

17. Caution: Investigational device and off label use of approved device
Extending Anatomy Proximally
Courtesy of J Anderson
Branched Grafts Hybrid Debranching
Courtesy of EB Diethrich

18. Caution: Investigational device and off label use of approved device
Courtesy of R Greenberg
Branched Grafts Hybrid Debranching
Extending Anatomy Distally

19. Branched Grafts
 Anatomic Reconstruction of Branches without any
major surgical Intervention
But
 Limited Availability
 Most are still custom made
 Require extensive Manipulation of Aneurysm
 Simple designs finally emerging and entering trials
 Chimneys are the poor man alternative !!

20. Caution: Investigational device and off label use of approved device
Branched Graft Examples
Chuter Design
Double helix (Greenberg)
WL Gore Single Branch

21. Debranching
 Relocation of Branches to a remote Non Aneurysmal Segment
 Allows a New Longer Landing zone for the Endograft
Goals
 Expand Therapeutic Window to Individuals who are not
candidate for open Repair
 Reduce Total Morbidity and Mortality
 Assumes that the total Hybrid mortality and morbidity is less
than the open surgery alternative: Unproven but likely for arch
procedures and less so for visceral debranching.

22. Early target: Covering the Left Subclavian!
Extended Landing Zone with Coverage of L Subclavian
A Carotid Subclavian bypass is not necessary in
all patients, but is preferable when feasible to
decrease neurologic complications

23. Coils
Carotid to carotid
And subclavian
Expanded use of TEVAR in Arch Aneurysms

24. Total Debranching for Complex Arch Aneurysms

25. Complex Hybrid Procedure with Elephant Trunk
Elephant Trunk after Arch Repair Elephant
Trunk
Post TAG
Placement

26. Old Surgical Graft
Type IV TAAA
Debranching
Source Left Iliac
Branch Celiac
and Rt Renal
Branch SMA
Branch L Renal
Expanded use of TEVAR in TAA Aneurysms

27. Celiac and SMA Coverage: Snorkels?
EM: 88 yo F with Rupture of Mycotic Aneurysm
23 mm cuffs
because of small
aorta
7mm Viabahns
in Celiac
and SMA

28. Visceral Debranching for Thoraco-Abdominal Aneurysms
Concern Regarding
Retrograde Perfusion
and durability of
Grafts
Occluded Rt renal
Graft 2 months
post-op. Renal infarct

29. Expanded Use of
Current Thoracic Endografts
to
Non-Aneurysmal Pathologies

30.  Ruptured DTA
 Thoracic Aortic Dissection
 Aortic Ulcer/Intramural Hematoma
 Traumatic Transection
 Embolizing lesions
 Aorto Bronchial Fistulas
 Other Aortic Pathology
Thoracic Endografts: Expanded Use

31. Main role of TEVAR: Complicated Type B
 Acute Type A Surgery
 Acute Type B Uncomplicated Medical Management
TEVAR ?
 Acute Type B Complications TEVAR
 Chronic Type B Stable Medical Management
 Chronic Type B Aneurysmal Surgery vs TEVAR?

32. Acute Complicated Type B Dissection
 End Organ ischemia or Malperfusion
 Rupture or suspected leak
 Unrelenting Back Pain/ Refractory HT
Treatment Aim with TEVAR
 Cover the Entry Tear
 Improve flow into the True Lumen
 Induce Thrombosis of the False Lumen
 Decrease Morbidity and Mortality
 Hopefully Prevent Late Complications
Adjuncts needed occasionally
 Endovascular fenestration or stent

33. Rx aimed at Perfusing Viscera and
Thrombosing the False Lumen
PRE
Post

34. WB: Type B dissection with SMA involvement
Visceral ischemia and poor left renal perfusion
PRE
Post

35. WB: Type B dissection with SMA involvement
Visceral ischemia and poor left renal perfusion
PRE
Post

36. European Heart Journal (2006) 27, 489-498.
 Technical success rate: 98%
 In Hospital Mortality: 5.2%
 In-hospital complication rate: 14-18%
 Stroke 1.9%
 Paraplegia 0.8%
 Surgical Conversion: 2.3%
 Adjunctive endovascular procedure: 1.5%
Cumulativemortality

37. J Vasc Surg 2010;52:860-6
National Inpatient Sample (US) 2005-2007
Open TEVAR
 Patients 3619 1381
 Mortality 19.0% 10.6% P<0.01
 Emergency 20.1% 13.1% P<0.03
 Elective 12.3% 4.8%
 Cardiac morbidity12.4% 4.9%
 Hemorrhage 14.0% 2.8%
 Renal Failure 32.1% 17.2%
 Hospital Stay 10.7 days 8.3 days

38. Circ Cardiovasc Interv 2013;6:407-416
INSTEAD Trial: 5 year FU
Uncomplicated Type B may also benefit from TEVAR
All Cause Aneurysm related
Mortality Mortality

39. J Thorac Cardiovasc Surg 2010; 139:1548-53
Beijing 2001-2007 84 patients
 Mean time from dissection 13.9 mo (1-120)
 Entry tear sealed 91.7%
 30 day Mortality 1.2%
 FU 1 retrograde dissection
4 second TEVAR for endoleaks
3 late deaths from rupture

40. Ann Thorac Surg 2010; 90:90-4
Bern and Vienna 2004-2009 14 patients
 Mean time from dissection 19 mo (4-84)
 Arch Debranching 7 patients
 30 day Mortality 0%
 Clinical success 86%
 Long term FU 2 Aortic related deaths

41. PS: Rapid Aneurysmal Degeneration
Oct 14, 06 / 38 x 38mm Nov 29, 06 / 51 x 51mm Dec 6, 06 / 54 x 55mm

42. PS: TEVAR @ 4 months- Jan 30 2007
Jan 30, 07 / Pre Jan 30, 07 / Post

43. PS: Follow-up after TEVAR for Chronic Dissection
Feb 1, 07 / 58 x 59mm Feb 28, 07 / 50 x 54mm July 7, 08 No Sac
June 2010 Thoracic aorta
Healed for 2 years

44.  Ruptured DTA
 Thoracic Aortic Dissection
 Aortic Ulcer/ Intramural Hematoma
 Traumatic Transection
 Embolizing lesions
 Aorto Bronchial Fistulas
 Other Aortic Pathology
Thoracic Endografts: Expanded Use

45. TEVAR Expanded Use: Aortic Injuries
 US: >8000/year
 High Prehospital Mortality (80%)
 Site: Majority at isthmus of aorta
 1200-1500 reach hospital alive
 30% die from aortic injury
 70-80% have associated injuries
 Non fatal Unrecognized lesions
develop false aneurysms over time.

46. Benefits of TEVAR for Aortic Transection
 Possible under Local anesthesia
 No Aortic Cross Clamping
 No or minimal Anticoagulation
 Does not interfere with
management of associated injuries
 No Thoracotomy

47. FS: 45 year old Male / MVA accident
Multiple Injuries: Long bone/ Abdomen
21-22 mm aorta 26mm Thoracic Endograft
FS: First generation Thoracic Endografts

48. JT: 29 year old Female / ATV vs Tree accident
Multiple Injuries: Head/ Abdomen / Pulmonary / Spine
17 mm AORTA
JT: Use of Cuffs for Transection
23 mm
Aortic cuffs

49. Main Concern with TEVAR for trauma
 Young Patients
 No Long term durability data
 Specific grafts only recently available
 Graft Collapse with old grafts
Causes: Oversizing and poor apposition
APR 08: 9 Year FU

50. Main Concern with TEVAR for trauma
 Young Patients
 No Long term durability data
 Specific grafts only recently available
 Graft Collapse with old grafts
Causes: Oversizing and poor apposition

51. Main Concern with TEVAR for trauma
 Young Patients
 No Long term durability data
 Specific grafts only recently available
 Graft Collapse with old grafts
Causes: Oversizing and poor apposition

52. Open Repair has a high Mortality and Morbidity
J Vasc Surg 2006: 43 (2): A22-A29
Open results
Clamp and Sew Distal Perfusion
Paraplegia Mortality Paraplegia Mortality
Von Oppell (94)
87 studies
1492 pts
19.0% 16.0% 6.1% 15.0%
Kadali (1991) 28.5% 3.8%

53. and Results have not Improved over 30 years
Single Center Series over 27 years
Attar et al Ann Thor Surg 1999
 263 patients over 27 years
 Operative Mortality
 1971-1975 19%
 1976-1984 36%
 1985-1994 26%
 1995-1998 16%
 Paraplegia 17%

54. 1997AAST Report: Open Results are poor
Fabian et al J Trauma 1997
 274 patients over 2.5 years from 50 centers
 From injury to thoracotomy: 16.5 hours
 Mortality 31% two thirds from Aortic source
 Paraplegia
 Full Bypass 4.5%
 Partial Bypass 7.7%
 Clamp and Saw 16.4%

55. J Vasc Surg 2006: 43 (2): A22-A29
Review of 17 Early reports of TEVAR
Patients Technical Success Mortality Paraplegia
Total 146 99% 2% 0

56. Traumatic Aortic Transection
TEVAR vs Open Thoracotomy at UPMC 1999-2010
 45 open Repairs 1999-2007
 9 deaths Mortality 19%
 3 paraplegia Paraplegia 6.6%
 50 TEVAR / 46 Acute: 15 cuffs / 2 TX2 / 32 TAG / 1 Talent
 2 deaths (PE, C2 inj) Mortality 4.0%
 No paraplegia Paraplegia 0%
Since Feb 2007 All Transections Rx by TEVAR

57. Traumatic Aortic Transection
 6 LSA coverage. 1 LCS bypass.
 1 stroke from associated inominate trauma with thrombus
 No conduits
 Mean FU 20 months . Longest 9 years
 Graft Related Complications
 3 isolated graft collapses treated with second TAG
 1 conversion @ 6 m after graft collapse and AEF
 1 conversion @ 3 yrs for Sx dynamic L Carotid obstruction
 1 conversion @ 2yrs for asymptomatic Carotid obstruction
 1 conversion @ 18 months for arm hypertension
TEVAR at UPMC 1999 - Apr 2010

58. LS: 27 month Follow-up Amaurosis and Light headedness
To and Fro motion in Left CCA on Duplex
Angiogram and Pressure measurement in LCCA
LS: Conversion for dynamic obstruction of LCCA
27 months

59. 2007 AAST Report
J Trauma 2008;64:1415-19
2007: 65% of All Transections in the US
are being managed by TEVAR with better
results

60. J Vasc Surg 2006: 43 (2): A22-A29
51 patients
No operative mortality
100% Technical success
No device related adverse events
No paraplegia
7.8% 30 day mortality
Approved for Trauma

61.  Ruptured DTA
 Thoracic Aortic Dissection
 Aortic Ulcer/ Intramural Hematoma
 Traumatic Transection
 Embolizing lesions
 Aorto Bronchial Fistulas
 Other Aortic Pathology
Thoracic Endografts: Expanded Use

62. Blue Toe Presentation is Common
Palpable Pedal Pulses
Usually Repetitive
and can lead to toe amputations or limb loss

63. Embolization Source: Thoracic Abdominal
 Recurrence 60% 8%
 Mortality 60% 11%
 Amputation 40% 17%
 Surgical treatment reduces embolization:7 vs 36%
J VASC SURG 1993;17:328-35

64. UPMC Experience: 2006-2012
 20 patients (65% women)
 12 Thoracic only and 8 with abdominal component
 After TEVAR
 No further embolization
 Kidney function stabilized in most and improved in 50%
 No Incidence of post-operative clinical embolizations

65. Stent Grafts for Atheroembolism: JS
 62 year old Truck driver
 March 06: Two Blue toes on left
 Renal dysfunction: Cr = 1.6
(Previous Cr 0.8-1.2)
 CT SCAN: Large Atheromas in
the Thoracic Aorta with Renal
Microemboli

66. Stent Grafts for Atheroembolism: JS
 Refused Stent Graft in Mar 06
due to employment
considerations
 Returned May 06: New episode of
Blue toes on the right
 Progressive Renal dysfunction:
Cr = 2.4
 Agrees to Stent-Graft Coverage.

67.  Thoracic Endograft June 06
 IVUS control. No contrast used
Stent Grafts for Atheroembolism: JS
Large Mobile plaque
IVUS
Probe

68.  Dec 2007. No recurrence. Cr: 1.7 CT scan
 No new renal infarcts / clean luminal surface
 Last FU 12/09 No recurrence. CR: 1.5
Stent Grafts for Atheroembolism: JS
March 2006. Pre Rx Dec 2007 Post RxDec 2007 Post Rx

69. Nov 08 Thoracic and Abdominal Aorta covered _ IVUS control
Stent Grafts for Atheroembolism: FN
Before Coverage After Coverage

70.  Different Pathology
 Consequences similar
 Same principles apply
Stent Grafts for Mobile Thrombus: TS
 TS: 44 year old Female
 Abdominal and flank pain
 Thoracic clot
 Splenic Infarcts
 Renal Infarct
 SMA embolus

71. Stent Grafts for Mobile Thrombus: TS
 TEE Control

72. Stent Grafts for Mobile Thrombus: TS
TREATMENT
 SMA embolectomy
 Stent Graft Coverage of the
Mobile thrombus
 No complications
 No recurrence

73. Eur J Vasc Endovasc Surg 2013;45:154-59

74. SUMMARY
 The role of Thoracic Endografts for treatment
of thoracic pathology continues to Expand
 Many improvements on the horizon will
increase the applicability to most anatomies
and types of Pathology