George Trellopoulos MDPapanikolaou Hospital

Thessaloniki

‘Advances in the Endovascular Management of the

Descending Thoracic Aorta Pathologies’

• Thoracic aneurysm - descending thoracic aneurysm - thoracic arch aneurysm - thoracoabdominal • Type B dissection - acute (complicated and uncomplicated) - chronic (complicated and uncomplicated)• Trauma disruption

– acute– remote (chronic)

• Other – penetrating aortic ulcers – pseudoaneurysm – IMH – aortobronchial fistula – aortoesophageal fistula – coarctation – anastomotic pseudoaneurysm – Shaggy aorta

Reported Applications for Reported Applications for Thoracic Stent Grafts Thoracic Stent Grafts

TransectionTransection

Dissecting AneurysmDissecting Aneurysm

AneurysmAneurysm

PseudoaneurysmPseudoaneurysm

Thoracic Aneurysms Results

• Eurostar 2006Eurostar 2006• TAG Phase IITAG Phase II• TTRTTR• VALOR TRIALVALOR TRIAL

• No randomized trials (Level 1 or 2)• Few case-control series• Numerous case series and registries

n 30d Mortality

Paraplegia

Verdant Montreal 1995 351 35(10%) 0

Galloway NYU 1996 62 4(6.5%) 0

Ehrlich Vienna 1998 58 18(31%) 6(10%)

Biglioli Milan 1999 143 8(5.5%) 7(5%)

Cooley THI 2000 132 17(13%) 11(8%)

Coselli Baylor 2004 387 17(4.3%) 10(2.6%)

Estrera/Safi UT 2005 300 24(8%) 7(2.3%)

Glade Nether 2005 53 6(11%) 4(8%)

Makaroun TAG 2006 94 11(11.7%) 13(13.8%)

Stone MGH 2006 93 14(15.1%) 8(8.6%)

1673 154(9.2%) 66(3.9%)

Results:Open Thoracic Aneurysm Repair

30 day mortality: 4.3-31%Paraplegia: 0-13.8%

Endovascular repair of the descending thoracic aorta: evidence for the change in clinical practice.

Sayed & Thomson, Vascular. 2005 May-Jun;13(3):148-57

• 1,518 patients underwent endovascular repair for thoracic aortic disease;• 810 thoracic aortic aneurysms • 500 type B thoracic aortic dissections• 106 traumatic ruptures• The 30-day mortality rate was 5.5% and 6% for late postoperative deaths • Primary technical success rate was 97% (only 15 patients requiring open conversion)• 118 endoleaks were reported; (29 were restented, and the remainder required surgical intervention). • Graft infection occurred in 6 cases• Migrations were detected in 10

n=656 n=457 n=142EurostarEurostar TTRTTR TAGTAG

Results of Endovascular Registries and Trials

VALOR PIVOTAL TRIAL: High Risk Arm

Multicenter (18 sites), prospective

study of Talent Thoracic patients with descending aneurysms

– 137 high risk patients

– 1 year follow-up

– 75% aneurysm, 7% pseudoaneurysm, 6% traumatic injury

Successful use of thoracic stent graft in high risk patients at 1 year

– 1 year mortality 24.1% (33/137)

– Paraplegia 0.8% (1/137)

– Stroke (13/137) 9.5% (8 in zone 1 or 2)

– Migration (>5mm) 1.5% (2/137)

– Endoleaks 7.5%(10 pts) (Type I 4 pts, Type II 5 pts, 1 unknown)

Data presented at VEITH 2006:

OPEN SURGER ARM: Data to be presented at SVS, June 2007

Results of Thoracic Endovascular Grafting in Different Aortic Segments

Melissano et al., J Endovasc Ther 2007;14;150-157

• 30 day Mortality 6.3% 2% 28.6%

• Technical Success 85.9% 98% 100%

• Spinal Cord Injury 3.1% 4% 7.1%

• Stroke 3.1% 1% 0%

• Endoleak 12.5% 2% 0%

Arch n=64 DTA (n=100) TaA n=14

• 30 day Mortality 11.8% 1.8%30 day Mortality 11.8% 1.8%

• Technical Success 88.2% 97.3%Technical Success 88.2% 97.3%

• 30 day clinical success 75% 96.4%30 day clinical success 75% 96.4%

Comparison of outcomes in the Hybrid and Non- Hybrid Comparison of outcomes in the Hybrid and Non- Hybrid Procedure Groups:Procedure Groups:

Hybrid n=68 Non-Hybrid n=110

Debranching Supraaortic Vessels and Visceral Vessels

““TEVAR is more challenging in the aortic arch due to its curvature movement and high flow”

“The evolution of fenestrated devices and further developments of totally endovascular techniques may represent an alternative to hybrid procedures”

Management of Type B Dissection

Complications to Acute Dissection•Mortality 10-20% / 30 day•Rupture 10%•Organ Ischemia 5-10%•Dilatation/Aneurysm 30-40%/ 4 years•Refractory Hypertension 5-10%

Uncomplicated Type B DissectionMedical Treatment

Uncomplicated Type B DissectionStent Grafting (Chronic)

Data presented at Veith 2006Data presented at Veith 2006

(1) 12 month all cause mortality Best medical management – 3% Endograft – 10% (NS)(2) Over 95% False Lumen Thrombosis with stent graft vs. over 50% with medical management(3) 7 patients (10,6%) of patients in medical management crossed over to stent graft in 1 year

««  For uncomplicated type B dissection a primary strategy of tailored anti-hypertensive medical

treatment and serial imaging is justified, with deferred stent-graft implantation as an option for patients

failing to respond to medical management. ». »

Uncomplicated Type B DissectionStent Grafting (Acute)

(IRAD 2006) Long-term survival in patients presenting with type B acute aortic

dissection: Insights from the International Registry of

Acute Aortic Dissection.Natural History of Acute Type B Dissection:

Tsai et al., Circulation 114:2226, 2006

N=317N=317

Medical RXMedical RX78%78%

EndograftEndograft11%11%

SurgerySurgery11%11%

In-hospital mortalityIn-hospital mortality10%10%

In-hospital mortalityIn-hospital mortality11%11%

In-hospital mortalityIn-hospital mortality29%29%

Complicated Type B Dissections

• Feasibility established by Nienaber classic 2003 report

• n = 11 patients with no in-hospital mortality

Open Surgery• 30 day mortality 30-60%• Paraplegia 20-30%

Complicated Type B DissectionsCombined experience from the EUROSTAR and United Kingdom Thoracic Endograft

RegistriesLeurs et al., J Vasc Surg 40: 670-80, 2004

• Technical Success 88,6% • Paraplegia or Paresis 0,8%• Stroke 1,5%• Endoleak 6,0%• 30 day Mortality 8,4 % (Elective 6.5%, Emergency 12%)

Aortic Dissection (elective n=62, Emergency 60%)

Concept of Endovascular Repair in Aortic Dissection

Complicated Type B DissectionDissected Aneurysm

Localization and IncidenceTransection

• Traumatic rupture of the aorta is usually fatal; only 10%-20% reach the hospital alive

• Of those reaching the hospital alive, an additional 5-10% die within a few hours due to massive, multi-system injury

• The appropriate treatment of the remaining 5- 10% remains controversial

Transection Open Surgery• Mortality 5-25%• Paraplegia 9-19%

Transection

• 39 published case series (2001-2006)• 352 patients

– 30 d mortality = 11.2% (0-23.1)– Paraplegia = None

Endovascular Repair

AVAILABLE DEVICESAVAILABLE DEVICES

Commercially Available Grafts

• GORE TAG• MEDRONIC TALENT (Valiant)• BOLTON RELAY • ZENITH XT2• ENDOMED ENDOFIT

• Variety of different technical properties and deployment techniques.

• Up to 10% oversizing and long overlapping (4-5 cm)

GORE Tag

After 2001:• the 2 longitudinal nitinol

spines were removed. (due to fractures)

• The middle layers of the PTFE were reworked to add rigitidity and assist with tracking and delivery of device

Video GORE

Medtronic Talent Thoracic / Valiant

Valiant Talent Valiant

Video MEDTRONIC

Critical Issue (1) • Paraplegia after endovascular stent grafting

Factors: Prevention and Treatment:

• Number of devices• Length of coverage >205 mm• Prior AAA• Hypotension (MAP <90)

• Preoperative imaging and identification of critical vessels• Cerebrospinal fluid drainage• Avoid perioperative hypotension

Retrograde Type A Dissection after EVAR

Critical Issue (2) Critical Issue (2)

Critical Issue (2a) Critical Issue (2a)

How to prevent

1. Careful aortic arch evaluation (no IMH, tortuocity, atheroma)

2. Limited Oversizing (10%)

3. Avoid postoperative hypertension

4. Avoid balloon moulding

Retrograde Type A Dissection after EVAR

Critical Issue (3)Endograft Collapse

• Out of 68 device compression reported to GORE, 72% occurred in patients with trauma related injuries

• 51/68 patients successful re- intervention confirmed

How to prevent

• Less oversizing in transection (2mm)• Overstendting of LSA• Stent graft with better apposition in the inner curve• Stent graft with more radial force

Critical Issue (3a)Endograft Collapse

Critical Issue (4) How to canalize the True Lumen

• Careful Pre-TEVAR imaging assessment (CTA, MRA, DSA for proximal entry , distal entry, extension of dissection

• Preparation of both Femoral and Brachial Arteries

• Canalise the true Lumen from Brachial to Femoral artery

• Angiography step by step

Critical Issue (5) How to advance the stent graft in severe tortuosity and

carvature arch

1. Brachial - femoral guidewire stretch technique

2. Use of 2 stiff guidewires from the femoral artery

3. Using a large dilatators from one femoral artery and 2 stiff guidewires from the other femoral artery

Summary Summary

Summary: Thoracic Endograft

• No randomized trials• Technical success in more than 98%• Type I endoleak is more common than Type II• Endograft associated with improved short-term outcomes (mortality, paraplegia)• 15-20% require iliac/aortic conduit• Coverage of LSCA is relatively benign and most avoid

prophylactic bypass except– Dominant L vertebral artery– Incomplete Circle of Willis– Patent LIMA

• SCI after endograft is less frequent than after open repair

Summary: Thoracic Endograft

• Endograft treatment of complicated type B dissections is SUPERIOR to open surgery

• Endograft treatment of uncomplicated type B dissections is INFERIOR to best medical management

• Role of endograft in treatment of traumatic aortic injury is feasible but of unproven benefit – No FDA-approved device

• SCI very rare in traumatic aortic injury