A multicentre investigation into migration of the Zenith fenestrated aortic stent-graft England A England A, García-Fiñana M, McWilliams RG & British Society.

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Presentation transcript:

A multicentre investigation into migration of the Zenith fenestrated aortic stent-graft England A England A, García-Fiñana M, McWilliams RG & British Society for Endovascular Therapy (BSET) Collaborators.

Financial Disclosure Funding – NIHR grant.

Displacement (drag) force BACKGROUND Complications – AAA reperfusion – Vessel occlusion – Rupture Maintaining fixation – Radial force – Hooks & barbs – Longitudinal columnar support – Suprarenal component – Target vessel stents

AIM To report using multicentre data the:- 1.Incidence 2.Timings 3.Related complications/reinterventions Proximal & distal (Iliac limb) migration of Zenith fenestrated AAA stent-graft.

METHODS Nine UK Centres approached Inclusion Criteria – FEVAR – Zenith (Cook) – CT Follow-up 1 st post-op CT scan (baseline) +1 additional CT scan (> 6 months) Endovascular databases – Sample description – Follow-up events (+CT data) Ethics, R&D approvals – Retrieval of CT data to Liverpool

MIGRATION DEFINITION ≥ 4 mm Movement of the device by ≥ 4 mm at either proximal or distal (iliac) landing zones 1. England et al., J Vasc Surg 2012;55:

2-YEAR CT SMA SAGITTAL CLL 1-MONTH CT (Baseline) SMA SAGITTAL CLL TOP STENT 17 mm TOP STENT CAUDAL 7 mm 24 mm 1-MONTH CT (Baseline) EIA BOTTOM STENT ANNUAL CT 8 mm CRANIAL 6 mm 2 mm BOTTOM STENT PROXIMAL DISTAL

RESULTS Included Clinical Site Total Cohort Available n% A836072% D441432% B362364% F231252% E191474% C191684% I18317% G14857% H6467% Total available cohort262 Included, n Included, % 154 Included n=154 Excluded n=108 P Value Age, yearsMedian 73 IQR 68 to 79 Median 74 IQR 69 to Gender, men140 (91%) 96 (89%) AAA diameter, mm Median 62 IQR 58 to 69 Median 60 IQR 58 to % MedianRange Follow-up, months

DEVICES Graft shape n% Bifurcated14393 AUI53 Tube64 Target vessel configuration n% CA Scallop (stented)29 (0)19 (0) Fenestration (stented)6 (6)4 (4) SMA Scallop (stented)93 (0)60 (0) Fenestration (stented)45 (44)29 (29) RT Renal Scallop (stented)7 (2)5 (1) Fenestration (stented)137 (137)89 (89) LT Renal Scallop (stented)6 (2)4 (1) Fenestration (stented)145 (144)94 (94)

PROXIMAL MIGRATION ≥ 4 mm In 33 patients (21%) - caudal Median migration +6 mm (range, +4.1 to mm) One migration per 10 person-years of follow-up Median time to migration = 12 months (range 6 to 89 months) ≥

FREEDOM FROM PROXIMAL MIGRATION Time, mo n. risk std. err % 77% 64%

DISTAL (iliac) MIGRATION ≥ 4 mm Out of 259 iliac limbs assessed – 34 (13%) showed migration (cranial) Median migration -6.1 mm (range, -4.1 to mm) One limb migration per 9.9 person-years of follow-up Median time to migration = 23 months (range 6 to 89 months)

RESULTS FREEDOM FROM DISTAL MIGRATION CONTRALATERAL LIMBIPSILATERAL LIMB

RESULTS FREEDOM FROM ANY DISTAL MIGRATION 85% 82% 65%

COMPLICATIONS REINTERVENTIONS ComplicationProximal migration P value No (n=121) Yes (n=33) Endoleak32 (26%)5 (15%)0.131 Target vessel loss10 (8%)4 (9%)0.349 Kinking8 (7%)5 (15%)0.116 Fracture6 (5%)1 (3%)0.535 ReinterventionProximal migration P value No (n=121) Yes (n=33) Endoleak4 (3%)1 (3%) TV Compromise6 (5%)2 (6%) 10 (8%)3 (9%)0.496

CONCLUSIONS Based on this multicentre analysis:- Migration – Proximal, – Distal (iliac), Movements – Minor (< 7 mm) Consequences – Minimal }

COLLABORATORS This project would not have been possible without the support from:- St. George’s Vascular Institute Cambridge University Hospitals Manchester Royal Infirmary University Hospitals of South Manchester Newcastle University Hospitals Royal Liverpool University Hospital Royal United Hospital Bath University Hospitals of Leicester Royal Free Hospital