the expanding clinical applications of tevar

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

Disclosures

Consultant:

WL Gore, Cordis, Medtronic

Research Grants:

WL Gore, Cook, CordisMedtronic, Boston Scientific, Abbott

Bolton, Lombard, Trivascular

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 !!

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

Requires Thoracotomy

Single lung ventilation

Heart bypass in many cases

Open Repair of DTA

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

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

J Vasc Surg 2008;47:912-8

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

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

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

J Vasc Surg 2013;58:346-54

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%

J Vasc Surg 2006;43A:20-21

By 200536% of Worldwide TEVAR use was for

OTHERNon Descending

Thoracic Aneurysm (DTA) applications

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%

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

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

Caution: Investigational device and off label use of approved device

Courtesy of R Greenberg

Branched Grafts Hybrid Debranching

Extending Anatomy Distally

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 !!

Caution: Investigational device and off label use of approved device

Branched Graft Examples

Chuter Design

Double helix (Greenberg)

WL Gore Single Branch

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.

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

Coils

Carotid to carotid And subclavian

Expanded use of TEVAR in Arch Aneurysms

Total Debranching for Complex Arch Aneurysms

Complex Hybrid Procedure with Elephant Trunk

Elephant Trunk after Arch Repair Elephant Trunk

Post TAGPlacement

Old Surgical Graft

Type IV TAAA

DebranchingSource Left IliacBranch Celiac

and Rt RenalBranch SMA

Branch L Renal

Expanded use of TEVAR in TAA Aneurysms

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

Visceral Debranching for Thoraco-Abdominal Aneurysms

Concern Regarding Retrograde Perfusion and durability of Grafts

Occluded Rt renal Graft 2 months post-op. Renal infarct

Expanded Use of Current Thoracic Endografts

to Non-Aneurysmal Pathologies

Ruptured DTA

Thoracic Aortic Dissection

Aortic Ulcer/Intramural Hematoma Traumatic Transection

Embolizing lesions

Aorto Bronchial Fistulas

Other Aortic Pathology

Thoracic Endografts: Expanded Use

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?

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

Rx aimed at Perfusing Viscera and Thrombosing the False Lumen

PRE

Post

WB: Type B dissection with SMA involvementVisceral ischemia and poor left renal perfusion

PRE

Post

WB: Type B dissection with SMA involvementVisceral ischemia and poor left renal perfusion

PRE

Post

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%

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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

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

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

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

PS: Rapid Aneurysmal Degeneration

Oct 14, 06 / 38 x 38mm Nov 29, 06 / 51 x 51mm Dec 6, 06 / 54 x 55mm

PS: TEVAR @ 4 months- Jan 30 2007

Jan 30, 07 / Pre Jan 30, 07 / Post

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

Ruptured DTA

Thoracic Aortic Dissection

Aortic Ulcer/ Intramural Hematoma

Traumatic Transection Embolizing lesions

Aorto Bronchial Fistulas

Other Aortic Pathology

Thoracic Endografts: Expanded Use

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.

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

FS: 45 year old Male / MVA accidentMultiple Injuries: Long bone/ Abdomen

21-22 mm aorta 26mm Thoracic Endograft

FS: First generation Thoracic Endografts

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

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

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

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

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%

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%

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%

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

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

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

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

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

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

Ruptured DTA

Thoracic Aortic Dissection

Aortic Ulcer/ Intramural Hematoma

Traumatic Transection

Embolizing lesions Aorto Bronchial Fistulas

Other Aortic Pathology

Thoracic Endografts: Expanded Use

Blue Toe Presentation is Common

Palpable Pedal PulsesUsually Repetitive

and can lead to toe amputations or limb loss

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

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

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

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.

Thoracic Endograft June 06 IVUS control. No contrast used

Stent Grafts for Atheroembolism: JS

Large Mobile plaque

IVUSProbe

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

Nov 08 Thoracic and Abdominal Aorta covered _ IVUS control

Stent Grafts for Atheroembolism: FN

Before Coverage After Coverage

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

Stent Grafts for Mobile Thrombus: TS TEE Control

Stent Grafts for Mobile Thrombus: TS

TREATMENT

SMA embolectomy Stent Graft Coverage of the

Mobile thrombus No complications No recurrence

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

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