Dr Peter Bungay Derbyshire Vascular Services Royal Derby Hospital Derby UK
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1 Dr Peter Bungay Derbyshire Vascular Services Royal Derby Hospital Derby UK
2 Disclosure I have the following potential conflicts of interest to report Consultant, proctor and paid speaker for Vascutek UK
3 Burfit t Fenestrated Anaconda - History Anaconda infra-renal graft CE mark 2005 First in man Fenestrated Anaconda June 2010 Indicated for short-necked to type 4 TAAA 1 to 4 fenestration devices, bifurcate or tube Publication of initial experience Bungay et al JVS 2011;54(6): th implant April 2012 Total to date 600
4 Why Anaconda? - Anatomical suitability - Ease of use - Results
5 Anatomical suitability
6 Broadening Anatomical Suitability Flexibility - 50 angulation
7 Broadening Anatomical Suitability Flexibility - 75 angulation
8 Angulation α & β angles
9 Non-parallel visceral segment
10 Tapering & Pleating
11 Broadening Anatomical Suitability Flexibility to accommodate non-parallel visceral segment
12 Broadening Anatomical Suitability Fenestrations of any size in any position
13 Broadening Anatomical Suitability Fenestrations of any size in any position Percentage suitability not quantifiable
14 Ease of use
15 Cannulation from brachial access Bail out for failed femoral cannulation Elective for steeply angulated visceral vessels
16 Reducing technical difficulty Repositionable graft body Accurate initial deployment Repositioning function maintained throughout procedure
17 Reducing technical difficulty Constraining graft assists cannulation
18 Results
19 Real world FEVAR data? Nordon (n=368) Globalstar (n=318) 30D Mortality 1.4% 4.1% (11% OR) Primary TVP 96.6% 99.4% Late TVP 92% 95% (3 years) Permanent Dialysis 1.4% Not reported Re-intervention 15% 6.3% (<30 days) EJVES 2009; 38:35-41 Circulation 2012 Jun 5;125(22):
20 Registry The Vascutek Anaconda TM Custom Fenestrated Stent Graft Post-Market Surveillance Study Observational post-market registry Started June 2010 with 1 st case Prospective Multicentre Web based
21 UK Experience UK Implants (Oct 2013) 138 (108 in Registry) UK 1 st 100 Registry Cases Follow up 1 year 67 (50) 2 years 23 (18) 3 years 3 (2) Number of UK Centres 15
22 UK Centres 1 st 100 Registry Cases Imperial 32 Royal Derby 29 Leeds 8 Frimley Park 7 Freeman 5 Queen Elizabeth Birmingham 3 Royal London 3 Norfolk and Norwich 3 Kings College 2 Western Infirmary Glasgow 2 Royal Free, London 2 Leicester Royal Infirmary 1 Oxford John Radcliffe 1 Stoke Mandeville 1 Aberdeen Royal Infirmary 1
23 UK 1 st 100 Registry Cases Graft design Fenestrations No. of cases 1 vessel 9% 2 vessel 54% 3 vessel 27% 4 vessel 10% (7 fenestrated cuffs 7%)
24 UK 1 st 100 Registry Cases Patient Demographics Mean age 75 (range 56-87) Mean AAA size 63mm (45-106mm) 82 male, 18 female
25 UK 1 st 100 Registry Cases Comorbidities Diabetes 12% Hypertension 60% Current smoker 22% Ex smoker 40% IHD 55% Congestive Cardiac failure 5% Chronic renal impairment 34% Cerebrovascular disease 4% Prior aortic surgery 2%
26 UK 1 st 100 Registry Cases ASA grade I 0% II 22% III 66% IV 12% V 0% Fit for open repair 54%
27 Results No aborted procedures open conversions >99% target vessel cannulation (1 failure of 238 target vessels) Endoleaks: End of procedure discharge/30 days I 5 2 II III 6 2
28 Results 30 day mortality 4 x 30 day deaths Myocardial infarction Mesenteric ischaemia (SMA dissection) Multi-organ failure (embolic) Stroke Anaconda FEVAR 30 day mortality 4%
29 GLOBALSTAR UK Retrospective study 14 Experienced centres (>10 FEVARs) 318 FEVAR cases GLOBASTAR 30 day mortality 4.1%
30 cf GLOBALSTAR UK Retrospective study 14 Experienced centres (>10 FEVARs) 318 FEVAR cases GLOBASTAR 30 day mortality 4.1% Anaconda 1 st UK 100 mortality 4% - 41% of cases at inexperienced centres UK Anaconda experienced centres mortality 3% (n=100)
31 1 year follow up 67 patients (data for 50) 2 deaths 1x MI, 1x type B dissection rupture 2x Renal stent occlusions >98% patency overall 1x iliac limb occlusion (fem-fem bypass) 1x CFA occlusion (ilio-profunda bypass)
32 1 year follow up 67 patients (data for 50) No migration No type I or III endoleak Sac Size Stable or decreased 49 (98%) Increased 1 (2%)
33 2 year follow up 23 patients (data for 18) 1x death (LVF) 1x Renal stent occlusion 96% patency (2/48) 1x graft infection No migration No type I or III endoleak Sac Size Stable or decreased 17 (94%) Increased = 1 (6%) >Type II Onyx embolization via SMA/IMA
34 3 year follow up 3 patients (data for 2) One patient refused follow up No further deaths No migration No endoleak Sac size decreased
35 So how does that compare? Nordon (n=368) Globalstar (n=318) Anaconda (n=100) 30D Mortality 1.4% 4.1% (11% OR) 4% Primary TVP 96.6% 99.4% 99.6% Late TVP 92% 95% (3 years) 96% Permanent Dialysis 1.4% Not reported nil Re-intervention 15% 6.3% (<30 days)?
36 Why you would not choose the Anaconda Fenestrated graft Neck diameter >31mm - largest graft 34mm Most Type 4 TAAA - longest body length 90mm Other TAAA - not a branched graft Very large or symptomatic AAA - custom made
37 Summary New FEVAR graft Potential for wider anatomical applicability Ease of use benefits High level of technical & clinical success UK multicentre results comparable to Globalstar
38 Thank you
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