Download - The expanding clinical applications of tevar
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The Expanding Clinical Applications of TEVAR
Michel Makaroun MDCo-Director UPMC Heart and Vascular Institute
Professor and Chief, Division of Vascular Surgery
University of Pittsburgh School of Medicine
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Disclosures
Consultant:
WL Gore, Cordis, Medtronic
Research Grants:
WL Gore, Cook, CordisMedtronic, Boston Scientific, Abbott
Bolton, Lombard, Trivascular
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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 !!
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WL GoreGore TAG device Approval 2005 C-TAG Approval 2011 (Trauma 2012 / Dissection 2013)
MedtronicTalent device Approval 2008Valiant 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
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Requires Thoracotomy
Single lung ventilation
Heart bypass in many cases
Open Repair of DTA
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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
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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+TAG ControlOpen Repair
EUROSTAR+UK
TAG TX2 TALENT Multiple
TEVAR Results vs Open Repair
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J Vasc Surg 2008;47:912-8
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Endo Open
Years Since Treatment
0 1 2 3 4 5
Su
rviv
al
1.0
0.8
0.6
0.4
0.2
0.0
Log Rank P = 0.01
FIVE YEAR FOLLOW-UP: Aneurysm Related Survival
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All Cause Mortality
Endo Open
Years Since Treatment
0 1 2 3 4 5
Su
rviv
al
1.0
0.8
0.6
0.4
0.2
0.0
Log Rank P = 0.40
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Freedom from Re-Interventions
Years Since Treatment
0 1 2 3 4 5
Fre
edo
m f
rom
Rei
nte
rven
tio
n
1.0
0.8
0.6
0.4
0.2
0.0
Log Rank P = 0.01
Endo Open
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J Vasc Surg 2013;58:346-54
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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%
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J Vasc Surg 2006;43A:20-21
By 200536% of Worldwide TEVAR use was for
OTHERNon Descending
Thoracic Aneurysm (DTA) applications
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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%
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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
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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
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Caution: Investigational device and off label use of approved device
Courtesy of R Greenberg
Branched Grafts Hybrid Debranching
Extending Anatomy Distally
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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 !!
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Caution: Investigational device and off label use of approved device
Branched Graft Examples
Chuter Design
Double helix (Greenberg)
WL Gore Single Branch
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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.
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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
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Coils
Carotid to carotid And subclavian
Expanded use of TEVAR in Arch Aneurysms
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Total Debranching for Complex Arch Aneurysms
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Complex Hybrid Procedure with Elephant Trunk
Elephant Trunk after Arch Repair Elephant Trunk
Post TAGPlacement
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Old Surgical Graft
Type IV TAAA
DebranchingSource Left IliacBranch Celiac
and Rt RenalBranch SMA
Branch L Renal
Expanded use of TEVAR in TAA Aneurysms
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Celiac and SMA Coverage: Snorkels?EM: 88 yo F with Rupture of Mycotic Aneurysm
23 mm cuffs because of small
aorta
7mm Viabahns in Celiacand SMA
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Visceral Debranching for Thoraco-Abdominal Aneurysms
Concern Regarding Retrograde Perfusion and durability of Grafts
Occluded Rt renal Graft 2 months post-op. Renal infarct
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Expanded Use of Current Thoracic Endografts
to Non-Aneurysmal Pathologies
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Ruptured DTA
Thoracic Aortic Dissection
Aortic Ulcer/Intramural Hematoma Traumatic Transection
Embolizing lesions
Aorto Bronchial Fistulas
Other Aortic Pathology
Thoracic Endografts: Expanded Use
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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?
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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
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Rx aimed at Perfusing Viscera and Thrombosing the False Lumen
PRE
Post
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WB: Type B dissection with SMA involvementVisceral ischemia and poor left renal perfusion
PRE
Post
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WB: Type B dissection with SMA involvementVisceral ischemia and poor left renal perfusion
PRE
Post
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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%
Cu
mu
lati
ve m
ort
ali
ty
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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
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Circ Cardiovasc Interv 2013;6:407-416
INSTEAD Trial: 5 year FUUncomplicated Type B may also benefit from TEVAR
All Cause Aneurysm related
Mortality Mortality
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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 endoleaks3 late deaths from rupture
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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
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PS: Rapid Aneurysmal Degeneration
Oct 14, 06 / 38 x 38mm Nov 29, 06 / 51 x 51mm Dec 6, 06 / 54 x 55mm
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PS: TEVAR @ 4 months- Jan 30 2007
Jan 30, 07 / Pre Jan 30, 07 / Post
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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 aortaHealed for 2 years
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Ruptured DTA
Thoracic Aortic Dissection
Aortic Ulcer/ Intramural Hematoma
Traumatic Transection Embolizing lesions
Aorto Bronchial Fistulas
Other Aortic Pathology
Thoracic Endografts: Expanded Use
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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.
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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
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FS: 45 year old Male / MVA accidentMultiple Injuries: Long bone/ Abdomen
21-22 mm aorta 26mm Thoracic Endograft
FS: First generation Thoracic Endografts
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JT: 29 year old Female / ATV vs Tree accidentMultiple Injuries: Head/ Abdomen / Pulmonary / Spine
17 mm AORTA
JT: Use of Cuffs for Transection
23 mmAortic cuffs
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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
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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
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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
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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%
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and Results have not Improved over 30 years
Single Center Series over 27 yearsAttar 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%
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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%
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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
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Traumatic Aortic TransectionTEVAR 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
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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
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LS: 27 month Follow-up Amaurosis and Light headednessTo and Fro motion in Left CCA on Duplex
Angiogram and Pressure measurement in LCCA
LS: Conversion for dynamic obstruction of LCCA
27 months
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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
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J Vasc Surg 2006: 43 (2): A22-A29
51 patientsNo operative mortality100% Technical successNo device related adverse
eventsNo paraplegia7.8% 30 day mortalityApproved for Trauma
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Ruptured DTA
Thoracic Aortic Dissection
Aortic Ulcer/ Intramural Hematoma
Traumatic Transection
Embolizing lesions Aorto Bronchial Fistulas
Other Aortic Pathology
Thoracic Endografts: Expanded Use
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Blue Toe Presentation is Common
Palpable Pedal PulsesUsually Repetitive
and can lead to toe amputations or limb loss
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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
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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
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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
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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.
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Thoracic Endograft June 06 IVUS control. No contrast used
Stent Grafts for Atheroembolism: JS
Large Mobile plaque
IVUSProbe
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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
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Nov 08 Thoracic and Abdominal Aorta covered _ IVUS control
Stent Grafts for Atheroembolism: FN
Before Coverage After Coverage
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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
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Stent Grafts for Mobile Thrombus: TS TEE Control
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Stent Grafts for Mobile Thrombus: TS
TREATMENT
SMA embolectomy Stent Graft Coverage of the
Mobile thrombus No complications No recurrence
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Eur J Vasc Endovasc Surg 2013;45:154-59
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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
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