What's on the Horizon™ for AAA: Unilateral &

Percutaneous, "UP-EVAR" System

Zoran Rancic M.D., Ph.D.

Clinic for Cardiovascular Surgery University Hospital Zurich

DISCLOSURES

STENOSIS, SEVERE CALCIFICATION, KINKS, OCCLUSIONS OF ONE ILIAC AXIS GROIN INFECTION STOMA CLOSE TO THE GROIN

What to do for a really LOW INVASIVE PROCEDURE in high risk patient?

COMMON SITUATIONS FOR UNILATERAL ACCESS

ATTEMPT OF EXTERNAL ILIAC RECANALIZATION: Risk of failure, occlusion of hypogastric ostium

LEFT AORTO UNILIAC EG WITH EXCLUSION OF RIGHT COMMON ILIAC. Occlusion of right hypogatric-femoral collateral vessels fem.-fem bypass mandatory – sometimes with general anesthesia Type II Endoleak for hypogastric retrograde flow

POSSIBLE APPROACHES

image courtesy of Prof G. coppi, MD

OPTION A - BILATERAL

A CONVENTIONAL BIFURCATED MODULAR GRAFT FROM LEFT GROIN COMPLETED WITH AN EXTENSION FOR THE RIGTH COMMON ILIAC

USING OMERAL/AXILLARY APPROACH

OPTION B – UNILATERAL

A BIFURCATED ENDOGRAFT DEPLOYED FROM A SINGLE ACCESS

2 ALTERNATIVES FOR HYPOGASTRIC PRESERVATION

image courtesy of Prof G. coppi, MD

CALIBER AND LENGTH OF THE DELIVERY SYSTEM INCREASED INVASIVNESS* SUBSTANTIAL COMPLEXITY

*too short and too large profile - dedicated devices for AAA EG limb extension (Advanta 7- 12F , Viabhan 6-12 F, Fluency 8-10F. availability)

2 Advanta 16 x 5.9

From Axillary a.

OPTION A – BILATERAL

OPTION B – UNILATERAL

• Implantation of the HORIZON™ Full Endovascular Stent-Graft

System, containing three different modules, in a

percutaneous approach from the left iliac artery.

• Local anesthesia

Single sided access (Unilateral)

True 14 Fr. OD (22 ÷ 31 mm Proximal Neck diameters)

Reproduces the native anatomy (preserves natural iliac bifurcation)

Modular design

Proximal transrenal active fixation

Distal fixation on the bifurcation

Eliminates the step of “short limb cannulation”

Flexible

HORIZON™ SYSTEM COMPONENTS

Connections are more secure, providing reliable prevention of detachment and/or Type III endoleaks.

Suprarenal active fixation and support on Aorto-iliac bifurcation reduces risk of migration.

Facilitates easy future contra lateral intervention.

Hourglass in Gateway

Dual Fixation

Preservation of natural iliac

bifurcation

Delivery system crossing profile of all modules – 14 Fr.

PROCEDURAL OUTCOME

image courtesy of Prof G. Coppi, MD.

2 MONTHS FOLLOW UP CTA

image courtesy of Prof G. Coppi, MD.

The Horizon™ CE study

• The study population: 30 patients, men and women, age ≥18 years, with AAA or AIA and having Iliac/femoral access vessel morphology that is compatible with vascular access techniques and devices.

• Prospective, non-randomized, open-label, one arm, and interventional clinical study.

• 9 sites: Eindhoven,Modena,Reggio-Emilia,Torino,Zurich,Dedinje-Belgrade,CCS-Belgrade,Ein-Carem,Beer-Jacob

• The trial’s primary endpoints is being evaluated at 30 days.

• Data is being collected at baseline, implantation, pre-discharge, 1, 6, and 12 months and annually thereafter until completion of 5 years follow-up.

• All adverse events, including deaths, is recorded throughout the course of the study.

The Horizon™ 30- day results

In total 27 patients No technical failure: 100% success in delivery and deployment Safety Results - No Major Adverse Events Reported during the FU visits to date.

a. No Aneurysm growth b. No Aneurysm rupture c. No Conversion to open surgery d. No Type I , III , IV endoleaks e. No stent graft migration f. No limb graft occlusion

The initial safety and effectiveness of the Horizon™ prosthesis is encouraging,

The HorizonTM represents a lower invasive and more appealing procedure

In some cases where is difficult to have both vasciular access possible the HorizonTM might be a first choice for AAA

14F delivery system makes the percutaneous approch safer and easier

To date, twenty seven (27) patients have been enrolled in the study and Endospan expects to complete enrollment in H1 2015

CONCLUSIONS