What's on the Horizon for AAA: Unilateral & Percutaneous, "UP-EVAR" System Zoran Rancic M.D., Ph.D.

Transcription

1 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

2 DISCLOSURES

3 COMMON SITUATIONS FOR UNILATERAL ACCESS What to do for a really LOW INVASIVE PROCEDURE in high risk patient? STENOSIS, SEVERE CALCIFICATION, KINKS, OCCLUSIONS OF ONE ILIAC AXIS GROIN INFECTION STOMA CLOSE TO THE GROIN

4 POSSIBLE APPROACHES 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 image courtesy of Prof G. coppi, MD

5 2 ALTERNATIVES FOR HYPOGASTRIC PRESERVATION 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 image courtesy of Prof G. coppi, MD

6 OPTION A BILATERAL CALIBER AND LENGTH OF THE DELIVERY SYSTEM INCREASED INVASIVNESS* SUBSTANTIAL COMPLEXITY 2 Advanta 16 x 5.9 From Axillary a. *too short and too large profile - dedicated devices for AAA EG limb extension (Advanta 7-12F, Viabhan 6-12 F, Fluency 8-10F. availability)

7 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

8 HORIZON SYSTEM COMPONENTS Delivery system crossing profile of all modules 14 Fr. Suprarenal active fixation and support on Aorto-iliac bifurcation reduces risk of migration. Dual Fixation Hourglass in Gateway Facilitates easy future contra lateral intervention. Preservation of natural iliac bifurcation Connections are more secure, providing reliable prevention of detachment and/or Type III endoleaks.

9 PROCEDURAL OUTCOME image courtesy of Prof G. Coppi, MD.

10 2 MONTHS FOLLOW UP CTA image courtesy of Prof G. Coppi, MD.

11 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.

12 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

13 CONCLUSIONS The initial safety and effectiveness of the Horizon prosthesis is encouraging, The Horizon TM represents a lower invasive and more appealing procedure In some cases where is difficult to have both vasciular access possible the Horizon TM 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