Thoracic Stent GraftZenith® TX1

Thoracic Stent GraftZenith® TX1

Thoracic Stent Graft

The Zenith® TAA One Piece Endovascular Graft is a

customized graft with the H&L-BOne-Shot™

Introducer System designed for endovascular repair

of Thoracic

Aortic Aneurysms (TAA) in the descending aorta. It

is intended for treatment of patients with

atherosclerotic aneurysms, symptomatic acute or

chronic dissections, contained ruptures, growing

aneurysms and/or aneurysms resulting in distal

ischemia.

• Aneurismal disease• Aortic dissection• Traumatic Aortic Rupture

Thoracic Stent GraftIndications

Thoracic Stent GraftContraindications

• Insufficient flow to sustain stent graft patency

• Arterial vessels incompatible with the delivery system

• Aneurysm dimensions outside range of the graftsystem dimensions

• Lesions that cannot be crossed with a delivery system

• Systemic infection

• Allergic reaction to contrast media, device materialsor anticoagulant therapy

• Congenital degenerative collagen disease(e.g. Marfan's syndrome)

• Pregnancy

• Thrombus in the proposed landing zones

• Risk of occlusion of the carotid artery, SMAor other vital vessels

The Thoracic Aorta is notthe Abdominal Aorta

• High flow and pulsatility• Different pathologies• Different anatomy

– larger diameter vessel– curved– different branch vessels to

consider

Advantages:• Tube Graft -

simple• Single groin

access

Disadvantages:• Curve• High flow

The Thoracic Aortais not the Abdominal Aorta

Device Design for ThoracicAorta• Accurate positioning• Flexible and conforms to curve

Characteristics ofthe Stent Graft

• Bottom uncovered stent with barbs– Thickness is 16/1000 inch, length 26 mm

• Sealing stent (internal)– Thickness is 15/1000 inch, length 17 mm

• Body stents (external)– Thickness is 14/1000 inch, length 14 mm

• Top sealing stent with barbs (internal)– Thickness is 16/1000 inch, length 17 mm

Woven Polyester Mesh

• Thickness is 0.35 mm • Porosity is 350 ml/min/cm2

• Suture material is – Green, polyester ethibond– Blue, polypropylene

Radiopaque Markers

• 4 gold markers at the top• 4 gold markers at the bottom• Longitudinal markers

Sizes

• Graft Diameter (REG. TRIAL)– 22-34 mm proximal and distal– length: min 75 mm/max 150 mm(Larger diameters available only upon request)

• Graft Diameter (CLIN. INVEST)– 22-42 mm proximal and distal– length: min 75 mm/max 225 mm

• Introducer Diameter– 18 FR for a graft diameter:-26 mm– 20 FR for a graft diameter:28 -34 mm– 22 FR for a graft diameter: 36 - 42 mm

Internal/External Stents

• Inner stents for sealing– One or two top internal stents possible– Top inner stent with barbs penetrating

the graft

• External stents– Smooth inner surface– Pressure from within the lumen; the

polyester mesh is being pushed againstthe stents

Gaps

• 5 mm gaps– Diameter of the graft 22-26 mm

• 7 mm gaps– Diameter of the graft 28-34 mm

• 10 mm gaps– Diameter of the graft 36-42 mm

Top Inner Stentwith Barbs

• 17 mm long (to facilitate the curve)

• Barbs are 5 mm long• Inside for sealing• Held by a release wire attached to

the release bottom on the introducer handle

Bottom Uncovered Stentwith Barbs

• 26 mm long• Barbs are 5 mm long• Secured at the bottom cap with a

release wire• Uncovered stent

– For safe distal fixation of the stent

Introducer System

• Sheath with hemostatic valve with sideport

• Metal needle tubing with COONS dilator• Pusher with bottom cap• Two release wires

Sheath

• 18 FR (22-26 mm)20 FR (28-34 mm)22 FR (36-42 mm)

• 70 cm long• Low friction PTFE

Metal Needle Tubewith Coons Dilator

• Curved• Straight• 100 mm long• 80 mm long• No sideholes for angiography!

Pusher

• Made from PVC• Attached to the handle with bottom

caps• Carrier of the two release wires

Handle

• Black release wire mechanismlocking bottom uncovered stent

• White release wire mechanismlocking covered top stent

Release Wires

• One to hold the proximal part closed• One through the bottom cap to

overcome accidental release of the bottom stent

• Both wires are connected with the blackand white knobs on the handle

Sliding Handle

• To release bottom uncovered stent

Pin Vise

• Locking mechanism for metal tube to control tip movement

Metal Tube

• Stopper to avoid unintended releaseof graft

• Lumen for .035 inch wire guide

Procedure

• In theatre or in the vascular radiology suite

• C-arm - mobile or stationary X-ray unit• Surgeon with radiologist

Preparation

• Artery selection for delivery system entry• Tortuosity of the access vessels

and aneurysm• Quality of the landing zones• Landing zone diameters• distance between the proximal

and distal landing zones

Preparation

• Unilateral femoral cut down• 2500 units of heparin/systemic dose• Prepare the device 10.000 units/100 ml• Catheter through the SCA

Image showing the catheter through the SCA

Image showing the catheter through the SCA

Placement

• Always under fluoroscopy• Over a 260 cm LES or AUS wire• Never rotate the introduction system• The dilator tip softens at body temp.• Connect a heparin drip

(1000u/500ml)

Deployment

• Lower patient’s blood pressure(if possible)

• Withdraw the sheath (verify positionwith angiography). You can push thegraft up, but never pull it down.

Further Deployment

• Continue to withdraw sheath until the hemoreduction valve docks with thecontrol handle

• Check position again and if okrelease safety wire 1

• Remove the security screw and withdrawthe front part of the handle till it dockswith the back part of the handle. Thebottom cap is opened

• Remove security wire 2 and the top willbe deployed

Finalizing

• Molding balloon• Final angiography

New Areas

• Rupture• Type B dissections

Thoracic Aortic Rupture• A new indication for stent graft?• Open repair - high

morbidity/mortality• Distance to left SCA - short prox.

neck• Optimal device design?• Frequently other serious injuries• Immediate or delayed treatment?

Traumatic thoracic aortic aneurysm:treatment with endovascular stent-graftsNH Kato, MD Dake, DC Miller, CP Semba,RS Mitchell, MK Razavi and ST Kee

Radiology 1997; 205: 657-662

Delayed treatment of traumatic rupture of the thoracic aorta with endoluminal covered stent

H Rousseau, P Soula, P Perreault, B Bui, et al

Circulation. 1999; 99: 498-504

Thoracic Aortic Rupture

Thoracic Aortic Rupture

Thoracic Aortic Rupture

Thoracic Aortic Rupture

Thoracic Aortic Rupture

Thoracic Aortic Rupture

Stent Graft for Type B Dissection; Issues

• Continued perfusion of falselumen mortality

• Medical Rx still has risk of rupture and progression

• Surgery has high risk of death andparaplegia

AIM: Aortic remodeling due to stent expansion of true lumen and thrombosis and retraction of false lumen

Nonsurgical reconstruction of thoracic aortic dissection by stent-graft placement

Christoph A Nienaber, Rossella Fattori, Gunnar Lund et al

N Engl J Med 340(20):1539-45, 1999 May 20

Conclusion: Preliminary observations suggest that elective, nonsurgical insertion of an endovascular stent graft is safe and efficacious in selected patients who have thoracic aortic dissection and for whom surgery is indicated. Endoluminal repair may be useful for interventional reconstruction of thoracic aortic dissection

Stent Graft for Type BDissection; Issues

• Lumen 5.5 cm or greater• Luminal expansion or pain• Proximal entry point to false lumen• Entry point 0.5 cm from LSCA• 1 iliac without dissection

Thoracic Aorta - Conclusions• Promising area• No long term data• Studies needed

Thoracic Aorta - Questions• Which cases to treat?• Acute or delayed treatment?• Custom or standard grafts?• Transpose LSCA?• Stop the heart?• Further improvements in design?

Thoracic Endovascular Graft

Anatomy