Sealing con polimero e stent sovra renali nei colleti difficili

Transcription

1 Forum tecnico su Sealing, fissazione e Endoleaks in EVAR Sealing con polimero e stent sovra renali nei colleti difficili Francesco Speziale Chief Vascular and Endovascular Surgery Division Department of Surgery Paride Stefanini Policlinico Umberto I Sapienza University of Rome

2 INTRODUCTION EVAR has been widely accepted as the procedure of choice for patients with AAA and suitable aortic anatomy Nowadays, up to 60-70% of infrarenal AAAs can be treated with the endovascular devices available.

3 ESVS/SICVE GUIDELINES Minimal requirement for Proximal Aortic Neck: Neck diameter mm Alfa angle <60 Beta angle Neck thrombus <50% perhaps, those requirement are too restrictive! Neck calcification <50% Neck length >10mm Moll F, et al. EJVES 2011 C Pratesi et al. It J Vasc Endovasc Surg 2015

4 REAL WORLD EXPERIENCE Published experiences using commercially available devices in patients with Challenging neck anatomy are continuously increasing ( >100 papers on PubMed) and good results are reported from many Centers around the World.

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6 CONCLUSIONS No significant differences were observed between 63on-L and 133off-L long-term followup (24 months). Speziale F et al. Ann Vasc Surg 2014

7 OVATION STENTGRAFT After 2012, a new-concept, uncoventional, polymer-based devices changed the game, providing new possibilities for complex AAAs treatment. Overcoming the current Guidelines on neck morphology for EVAR, only one anatomical parameter is required:

8 OVATION STENTGRAFT IR+13 diameter 30mm

9 OVATION STENTGRAFT

10 FIRST EXPERIENCE Even if during our learning curve, Ovation stentgraft was adopted to treat a very selected patients population not amendable for treatment with conventional endograft.

11 FIRST EXPERIENCE

12 FIRST EXPERIENCE 21 Ovation Patients 17 (80.9%) challenging neck 18 (85.7%) challenging accesses 15 (71.4%) neck and accesses 9±5 (3-27) months: No type I or III endoleak 3 type II endoleaks 1 limb graft thrombosis Sirignano P, Speziale F et al. JCVS 2016

13 EXTENSIVE EXPERIENCE Moving from that initial positive experience, we decided to test the Ovation stentgraft in a lessselected cohort of patients treated for elective AAA in a double centers experience.

14 EXTENSIVE EXPERIENCE Ann Vasc Surg 2017 In press

15 EXTENSIVE EXPERIENCE 156 elective patients, 48% of them presenting a challenging neck, were treated from January 2012 to Decemeber 2015 Sirignano P, Speziale F et al. Ann Vasc Surg 2017 In press

16 EXTENSIVE EXPERIENCE Log-rank test showed no significant differences in terms of freedom from reinterventions for short aortic neck (<10mm) Sirignano P, Speziale F et al. Ann Vasc Surg 2017 In press

17 ONGOING EXPERIENCE To confirm those results, a prospective multicentric international study was designed

18 ONGOING EXPERIENCE Expanding Indications for Treatment with Standard EVAR in Patients with Challenging Anatomies, a Multi-Centric Prospective Evaluation EXTREME Registry Speziale F et al. Ann Med Surg 2017

19 ONGOING EXPERIENCE Enrolment started on March 2017, involving 17 centers across Italy and Spain P.I. F Speziale, Rome Italy A Argenteri, Pavia Italy S Bartoli, Rome Italy S Camparini, Cagliari Italy R Gómez, Malaga Spain A Ippoliti, Rome Italy M Lenti, Perugia Italy N Mangialardi, Rome Italy J Martinez, Jaen Spain C Novali, Cuneo Italy G Pogany, Rome Italy M Piñero, Cádiz Spain C Setacci, Siena Italy R Silingardi, Modena Italy F Spinelli, Rome Italy F Talarico, Palermo Italy M Taurino, Rome Italy Speziale F et al. Ann Med Surg 2017

20 ONGOING EXPERIENCE Up to September 2017: 59 enrolled pts mean neck length 5.8±2.9mm mean AAA diameter 48.7±5.9 mm 29/57 pts completed 30-day FU 1/57 reinterventions for limb occlusion

21 CONCLUSION Results obtained using Ovation stent-graft in our series seem to confirm that polymerbased EVAR could be considered a safe and reliable option, even in patients judged unfit for standard EVAR with conventional endografts

22 Symposium Chairman Francesco Speziale Scientific Secretariat Laura Capoccia Wassim Mansour Pasqualino Sirignano Vascular and Endovascular Surgery Division Department of Surgery Paride Stefanini Sapienza University of Rome Policlinico Umberto I caput.meeting@gmail.com