UC SF The Short Neck: What is the Role of Anchors, Chimneys, Z-Fen? Jade S. Hiramoto, MD, MAS UCSF Vascular Symposium April 4, 2019 VASCULAR SURGERY • UC SAN FRANCISCO 1 UC SF Disclosures • Research support and royalties from Cook, Inc. VASCULAR SURGERY • UC SAN FRANCISCO 2 1
UC EVAR: The Short Neck SF • Unfavorable proximal aortic neck: increased risk of failure after EVAR - Short neck - Highly angulated - Conical (reverse taper morphology) - Thrombus/calcium • Currently marketed endografts IFU require neck length of 10-15 mm • Increased risk of endoleak and migration VASCULAR SURGERY • UC SAN FRANCISCO 3 UC EVAR: The Short Neck SF • Augment the neck - Endoanchors • Raise the neck - Chimney grafts - Fenestrated devices VASCULAR SURGERY • UC SAN FRANCISCO 4 2
UC EndoAnchors SF • Heli-FX EndoAnchor system (Medtronic, Santa Rosa, CA) • Designed as adjunct to EVAR • Enhance fixation and sealing of endograft within proximal aortic neck • May be helpful in cases of highly angulated or short neck • Contraindicated if mural thrombus or calcium present at site of intended deployment - Prohibit penetration of EndoAnchor into aortic wall VASCULAR SURGERY • UC SAN FRANCISCO 5 UC EndoAnchors SF • Advantages - Improve fixation/sealing of endograft to proximal aortic neck - “Mimics” surgical sutured anastomosis • Disadvantages - Subsequent open surgery may be harder VASCULAR SURGERY • UC SAN FRANCISCO 6 3
Augmenting the Neck: UC SF EndoAnchors Jordan et al; J Vasc Surg 2014;60:885-92 VASCULAR SURGERY • UC SAN FRANCISCO 7 ANCHOR Prospective UC SF Multicenter Registry • 2/2012-12/2013: 319 patients from 43 sites in the US/Europe - Asymptomatic, symptomatic, or ruptured AAA • Primary arm: - EndoAnchor implantation at same time as initial EVAR procedure - High risk anatomy for future proximal neck complication, based on opinion of investigator - Treated for prophylaxis of endoleak or migration - Type IA EL at initial EVAR procedure • Secondary arm: - Prior EVAR with type IA EL or endograft migration Jordan et al; J Vasc Surg 2014;60:885-92 VASCULAR SURGERY • UC SAN FRANCISCO 8 4
UC SF ANCHOR Prospective Multicenter Registry (n=242) (n=77) (n=319) • Procedural success=technical success without type IA EL Jordan et al; J Vasc Surg 2014;60:885-92 VASCULAR SURGERY • UC SAN FRANCISCO 9 UC ANCHOR Prospective SF Multicenter Registry • During mean follow-up of 9.3 ± 4.7 months, no new type 1A EL or endograft migration after index procedure • Single center study of 51 patients: 87% 2 year freedom from type IA EL (Goudeketting et al; JEVT 2019; 26(1):90-100) Jordan et al; J Vasc Surg 2014;60:885-92 VASCULAR SURGERY • UC SAN FRANCISCO 10 5
Raising the Neck:Chimney Grafts UC SF • Placement of stent into branch vessel with proximal part of stent extending above proximal edge of aortic stent graft • Allows more proximal placement of aortic stent graft in short-necked AAAs while maintaining perfusion to viscera and kidneys Hiramoto et al; J Vasc Surg 2009;49:1100-6 VASCULAR SURGERY • UC SAN FRANCISCO 11 Raising the Neck:Chimney Grafts UC SF • Chimney grafts from brachial/axillary arteries • Aortic stent-graft deployed from femoral arteries • Main stent-graft ballooned simultaneously with branch vessel stents Yammine H et al; Tech Vasc Interventional Rad VASCULAR SURGERY • UC SAN FRANCISCO 2018;21:165-174 12 6
Raising the Neck:Chimney Grafts UC SF • Advantages: - Standard, off-the shelf components - May be less technically challenging than fenestrated device • Disadvantages: - Gutters: blood flow through channels between main body of aortic endograft and chimney grafts - Chimney stents may become kinked, compressed, or occluded - Stroke risk (upper extremity access) Yammine H et al; Tech Vasc Interventional Rad VASCULAR SURGERY • UC SAN FRANCISCO 2018;21:165-174 13 PERICLES Registry: UC SF Collected World Experience • Largest collection of ch-EVAR procedures • 517 patients treated from 2008-2014 • “Real world” clinical practice • 20% cases symptomatic, rapid expansion, ruptured • Aneurysm classification: - Juxtarenal AAA n=360 (70%) - Suprarenal AAA n=129 (25%) - Type IV TAAA n=28 (5%) VASCULAR SURGERY • UC SAN FRANCISCO Donas et al; Ann Surg 2015;262:546-553 14 7
UC PERICLES Registry: SF Collected World Experience • Type IA intraoperative EL in 41 patients (8%) - 15 patients (3%) with persistent EL despite corrective measures - Technical success 502/517 cases (97%) • 30 day mortality: 5% - Four procedural-related deaths • Mean follow-up 17.1 months (range 1-70 months) - Primary chimney patency 94% - No difference if balloon-expandable or self-expanding stent used Donas et al; Ann Surg 2015;262:546-553 VASCULAR SURGERY • UC SAN FRANCISCO 15 PERICLES Registry: UC SF Collected World Experience Occlusion-free survival of balloon expandable chimneys • What is the optimal device combination for ch-EVAR? - Unclear • No difference in chimney occlusion rates between aortic device types with BECS - Trend toward higher occlusion rate with BECS in Group C Group A=nitinol/polyester Group B=stainless steel/polyester Group C=nitinol/PTFE VASCULAR SURGERY • UC SAN FRANCISCO BECS=balloon-expandable covered stent 16 8
UC PERICLES Registry SF • Significant occlusion-free survival advantage in those with lower number of chimney stents • 1.8 fold-increased risk of occlusion for each additional chimney stent • Use of bare metal “endolining” stent doubled occlusion hazard risk Scali et al; JVS 2018;68:24-35 VASCULAR SURGERY • UC SAN FRANCISCO 17 Raising the Neck: UC SF Fenestrated Devices (FEVAR) • Advantages: - FDA-approved indication for juxtarenal AAA repair - No gutters • Disadvantages: - Manufacturing delay - Technically challenging - Costs VASCULAR SURGERY • UC SAN FRANCISCO 18 9
Zenith FEVAR UC SF Oderich et al; JVS 2014;60:1420-8 VASCULAR SURGERY • UC SAN FRANCISCO 19 Zenith FEVAR U.S. UC SF Multicenter Trial • First prospective multicenter analysis of FEVAR to treat juxtarenal AAA • 67 patients enrolled in 14 US centers from 2005-2012 • Custom-made fenestrated stent-grafts with one to three fenestrations • Renal alignment with balloon-expandable stents - Covered and uncovered stents Oderich et al; JVS 2014;60:1420-8 VASCULAR SURGERY • UC SAN FRANCISCO 20 10
Zenith FEVAR U.S. UC SF Multicenter Trial: Results Oderich et al; JVS 2014;60:1420-8 VASCULAR SURGERY • UC SAN FRANCISCO 21 UC SF Systematic Review of FEVAR • 763 patients and 2040 target vessels • 93% technical success • 30 day mortality 1.7% (range 0-4%) • 74 target vessels occluded (3.6%) - 9 intraoperative - 65 during follow-up • 90% freedom from re-intervention at 1 year Ou et al; Ann Vasc Surg 2015;29:1680-88 VASCULAR SURGERY • UC SAN FRANCISCO 22 11
FEVAR vs ch-EVAR: UC SF How Do They Compare? • Systematic review/meta-analysis of 42 studies with 2264 patients undergoing FEVAR and ch-EVAR - 25 studies of FEVAR - 13 studies of ch-EVAR - 4 studies containing both • 4413 target vessels Yaoguo et al; Vascular 2017;25(1):92-100 VASCULAR SURGERY • UC SAN FRANCISCO 23 FEVAR vs ch-EVAR: UC SF How Do They Compare? Yaoguo et al; Vascular 2017;25(1):92-100 VASCULAR SURGERY • UC SAN FRANCISCO 24 12
FEVAR vs ch-EVAR: UC SF How Do They Compare? Yaoguo et al; Vascular 2017;25(1):92-100 VASCULAR SURGERY • UC SAN FRANCISCO 25 Complex EVAR: VQI UC SF O’Donnell et al; JVS 2019;1 -12 VASCULAR SURGERY • UC SAN FRANCISCO 26 13
Complex EVAR: VQI UC SF Adjusted Odds Ratios for Outcomes • Perioperative death (p=0.13) - 3.4% FEVAR - 2.7% PMEG - 6.1% ch-EVAR • Overall survival 91% at 1 year and 88% at 3 years - No difference between repair types • Ch-EVAR cases: - More arm/neck access - Longer procedural times - Used more contrast material - Increased risk of stroke, MI, MACE O’Donnell et al; JVS 2019;1 -12 VASCULAR SURGERY • UC SAN FRANCISCO 27 UC SF FEVAR/ch-EVAR vs Open Repair • National Surgical Quality Initiative Program (NSQIP) Database 2012-2016 • Examined 30 day outcomes of FEVAR, ch- EVAR and open repair for juxta, para, and suprarenal AAA • 1191 patients underwent AAA repair - 72% open repair - 14% FEVAR - 14% chEVAR Locham S et al; Vasc Endovasc Surg 2019; 53(3):189-198 VASCULAR SURGERY • UC SAN FRANCISCO 28 14
UC SF NSQIP Data:30 Day Outcomes Locham S et al; Vasc Endovasc Surg 2019; 53(3):189-198 VASCULAR SURGERY • UC SAN FRANCISCO 29 UC SF NSQIP Data:30 Day Outcomes Open AAA repair associated with 2 to 5-fold increase in mortality, renal, and cardiopulmonary complications Locham S et al; Vasc Endovasc Surg 2019; 53(3):189-198 VASCULAR SURGERY • UC SAN FRANCISCO 30 15
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