XV. ULUSAL VASKULERCERRAHI KONGRESI

Mr. Paul Bachoo

Consultant Vascular Surgeon

Aberdeen

Scotland

WHY REPOSITIONABLE ?

Proximal aortic neck diameter> 28mm

Length <15mm

11-15mm

<10mm

• Angle >60

• Reverse taper / bulging neck

• Thrombus lining

• Calcification

Neck 10mm

Angle 94

Aberdeen case

Stent graft

attributes

ACCURATE

DEPLOYMENT

Aberdeen: 3mensio Vascular Tera-recon

Trans renal Infra renal

Top downBottom up

Repositionable

Device Manufacturer Stent Graft Delivery Special feature

Talent Medtronic Nitinol Woven Polyester

Integratedsheath

Pararenal bare stent

Zenith Flex Cook Stainless steel

WovenPolyester

Integrated sheath

Uncovered stent, suprarenal fixation

Powerlink Endologix Cobalt chromium

ePTFE Integrated sheath

Sits on bifurcation

Device Manufacturer Stent Graft Delivery Special feature

Anaconda Vascutek Nitinol WovenPolyester

Integrated sheath

RepositionableMagnetic guidance

Aorfix Lombard Nitinol WovenPolyester

Integrated sheath

Crumple zone

Endurant Medtronic Nitinol Woven Polester

Integrated sheath

Pararenal bare stent,suprarenal hooks

Endoframes Endobags

Infrarenal

hooks

NitinolePTFE

RepositionableTop down

Infra renal

Deploy the trunk to the contra gate. This allows distal

perfusion and prevents wind sock effect

Repositioning is not mandatory

Point of no return

Step 3: deploying the ispi legDeploying the ipsi-lateral leg

However if repositioning is required

Constraining the trunk will disengage the anchoring

pins and allow re-positioning of the device

After repositioning

Deploy Trunk

Attempt Cannulation

Remove

Constraining

Mechanism

Deploy ipsi

Balloon Trunk-ipsi

Reposition

Reposition

Happy

With

Position?

Success?

NoYes

Yes

No

Deploy Contra

Confidence

Take on challenging aortic neck anatomy Angulated long Angulated short Straight short

Train future endovascular surgeons Introduce surgeons experienced in open AAA surgeons to EVAR Allow experienced endovascular surgeons to take on challenging

anatomy

Short straight neck

Courtesy of Professor Eric Vorhoeven

C3 ADDRESSES THE INABILITY OF BEING ABLE TO RELIABLY PREDICT THE EXACT LANDING SITE OF A GRAFT WITHIN A CURVED SEGMENT

Site

Number Site Name

Procedure Date

Range

C3 Deployment

System

203 Klinikum Nürnberg Süd 08/10 - 10/11 40(24.2%)

209 University of Cologne University Clinics 09/10 - 09/11 17(10.3%)

215 Klinikum der Universität Regensburg 08/10 - 08/11 12(7.3%)

218 University of Heidelberg 03/11 – 8/11 8(4.8%)

263 Hospital Clinic I Provincial de Barcelona 09/10 – 6/11 5(3.0%)

264 Orebro University Hopsital 9/10 – 6/11 16(9.5%)

278 Aberdeen Royal Infirmary 9/10 – 10/11 32(19.0%)

279 Cambridge University Hospitals NHS Trust 09/10 - 09/11 13(7.9%)

280 Royal Liverpool University Hospital 09/10 – 10/11 16(9.7%)

283 Weißeritztal Kliniken GmbH 08/10 - 05/11 9(9.5%)

Total Subjects Enrolled 08/10 - 10/11 168

C3 Device

N (C3) / N (ABD) =168(%)

%Male 85 / 87

Age (yrs)

Mean (Std Dev) 73.7 / 74 (7.7)

Median 75.0

Range (51.0-90.0)

Patient demographics & surgical risk factors

ASA Classification NYHA Classification

Number Responding 162 Number Responding 161

I 3 / (1.9) I 28(18.0)

II 52(32.1 / 10) II 89(55.3)

III 100(61.7 / 70) III 29(18.0)

IV 7(4.3 / 10) IV 0(0.0)

V 0(0.0) No Cardiac Disease 14(8.7)

N=161(%)

Aortic Pathology

Abdominal aortic aneurysm 157(97.5 / 100)

Common iliac aneurysm 3(1.9)

Abdominal aortic aneurysm rupture 1(0.6)

Reason for Treatment

Primary Procedure for Endovascular Treatment 155(96.3 / 100)

Reintervention of an Open Surgical Procedure 3(1.9)

Reintervention of a Prior Endovascular Procedure 2(1.2)

Aneurysm Diameter (mm)

n 155

Mean (Std Dev) 58.4(60)

Median 56.0

Range (35.0,95.0)

Proximal Neck Length (cm)

n 154

Mean (Std Dev) 2.9 (2.1)

Median 2.5

Range (0.3,21.0)

Infrarenal Neck Angle

n 147

Mean (Std Dev) 27.7(24.4)

Median 22.0

Range (0.0,100.0)

Case Planning

Information

Neck Length < 1.5 cm 13(8.1%)

Neck Angulation ≥ 60 15(9.3%)

Significant Calcification at

Landing Zones

28(17.4%)

Significant Thrombus at

Landing Zones

18(11.2%)

Anesthesia Method n (%)

General 149 (92.5 / 100)

Regional 11(6.8)

Local 0

Procedure Survival 161(100 / 100)

Procedure Time (skin-to-skin)

Mean (Std Dev) 126.7(65.4 / 70)

Median 110.0

Range (60.0,477.0)

Hospital Stay (Days)

Mean (Std Dev) 6.6(8.1 / 3)

Median 5.0

Range (1.0,93.0)

Number of Enrolled Subjects n=168(%)

Number of Cases Requiring Trunk Repositioning 91/8(57)

Reasons for Repositioning

Positioning Closer to Renal Arteries 67 / 7(42)

Contralateral Gate Positioning 27(17)

Other 16(10)

Number of cases requiring repositioning n=95

Number of Repositions per Case

1 61 (7)

2 24(1)

3 5

4 1

Missing 4

Number of Enrolled Subjects 168 (%)

95% CI1

Device Deployed Where Planned 150(93 / 100) (88.2%,96.1%)

Deployed ≥5mm from intended location 4(2.5%) (1.0%,6.2%)

Number of Enrolled Subjects n=168 (%)

Subjects with Aortic Extender(s) Implanted 8 / 2 (5.0)

Subjects with unplanned Aortic Extender(s) 7 (4.3)

Reasons for Unplanned Extender Use

Increase Seal 1 (0.6)

Extend Landing Zone 1 (0.6)

Type I Endoleak 5 (3.1)

Number of Enrolled Subjects n=168 (%)

Any In-Hospital Serious Event 4 / 0 (2.4)

Iliac artery occlusion 2 (1.2)

Device Dislocation 1 (0.6)

Renal haemorrhage 1 (0.6)

Surgical mortality = 0

30 day mortality = 0

Death reported at day 35 due to renal sepsis from dialysis

Death reported at day 173 due to subdural hematoma

Why repositionable ?

Controlled delivery Controlled and precise adjustments in a vertical plane Controlled orientation of contra-lateral limb in a horizontal

plane Controlled proximal landing at preferred site avoiding

calcium plaques / thrombus/preserving accessory renals Controlled proximal landing within a angled neck Controlled and safe training Controlled constraint and disengagement of hooks Controlled use of aortic cuffs / expenses

If not the first time certainly by the third repositioning you will achieve your intended proximal landing site