Post on 12-Feb-2020
Fenestrated Anaconda™: Experience in 101 cases in the UK
Robin WilliamsFreeman Hospital
Newcastle-upon-Tyne
Frances E Colgan a
Michael J Clarke a
Peter M Bungay b
John W Quarmby b
Nicholas Burfitt c
Alun H Davies c
Mike Jenkinsc
Andrew Hatrick d
David Gerrard d
a Freeman Hospital, Newcastle-upon-Tyne
b Royal Derby Hospital, Derby
c Imperial College, London
d Frimley Park Hospital, Frimley
Disclosure
Speaker name: Robin Williams
I have the following potential conflicts of interest to report:
Consulting
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
x
Predictors of Abdominal Aortic Aneurysm Sac Enlargement After Endovascular Repair
Andres Schanzer, MD Roy K. Greenberg, MD et al
Circulation 2011 jun 21;123(24) :2848-55
10228 patients
42% of patients had anatomy that met the most conservative definition of device instructions for use
69% met the most liberal definition of device instructions for use.
5-year post-EVAR rate of AAA sac enlargement was 41%
Independent predictors of AAA sac enlargement
endoleak, age ≥80 years, aortic neck diameter ≥28 mmaortic neck angle >60°
common iliac artery diameter >20 mm
Supra-renal OR mortality >10% in England
NVD & HES data
Elective open suprarenal aneurysm repair in England from 2000 to 2010 an
observational study of hospital episode statistics.Karthikesalingam A1, Holt PJ, Patterson BO, Vidal-Diez A, Sollazzo G, Poloniecki JD, Hinchliffe RJ, Thompson MM.
PLoS One. 2013 May 23;8(5):e64163. doi: 10.1371/journal.pone.0064163. Print 2013.
Anaconda Fenestrated Range
UK
Germany
Austria74
228
300
France 67
Netherlands
Italy 46
64
Canada 45
Spain 41
Belgium 35
Australia 11
Brazil 9
Switzerland 7
Monaco
Chile 2
6
Hungary 2
Sweden 2
Poland 1
Implanted Devices to Date
…by Country
1727 Cases
• Four UK centres
– Royal Derby Hospital, Derby
– Imperial College/St Mary’s Hospital, London
– Frimley Park Hospital, Surrey
– Freeman Hospital, Newcastle
– All completed >20 cases• learning curves included,
much like Globalstar
UK four centre study
First 101 devices (prospective, consecutive series, unfunded)
Juxta renal, para-visceral, type IV TAAAno previous EVAR - cuffs and re-lines excluded
2010- 2014 Q1
- includes the first Anaconda fEVAR
data from the individual centres
Demographics
– 85% male
– median age 76 years (range 56-89 years)
– 52% described as “not fit for open repair”
Co-morbidity Number (n=101)
Diabetes 13 (13%)
Hypertension 72 (72%)
Ischaemic heart disease 53 (53%)
Congestive cardiac failure 5 (5%)
Chronic renal impairment 39 (39%)
Cerebrovascular disease 10 (10%)
Prior aortic surgery 2 (2%)
ASA grade Number of
patients (n=101)
1 0
2 21
3 67
4 10
5 0
Not stated 3
Graft type
4%
49%36%
11%
Number of fenestrations
1
2
3
4
30 day outcomes
• Technical success: 97%
– Aneurysm excluded (no type I or type III endoleak)
Procedural Endoleaks
Procedural 30 day
Type I 11% 2%
Type II 15% 22%
Type III 4% 1%
Type IV 1%
U/C 1%
30 day outcomes
• Type I/III endoleaks
– 9/11 type I endoleaks sealed spontaneously within 30 days
• one type Ib treated with angioplasty
• one considered for APTUS but had resolved by the time the patient attended for treatment (after 30 days)
– 3/4 type III endoleaks sealed spontaneously within 30 days
• left renal fenestration impossible to cannulate due to graft twist.
• 2nd attempt failed
• artery occluded with plug (after 30 days)
Target vessel patency – 30 day
• All vessel (incl valleys) 99.6%
• Stented vessels 247/251 = 98.4%
• coeliac artery occluded pre-op
• failed catheterisation of renal artery due to graft twist
– silent renal artery occlusion
– SMA delayed dissection with vessel occlusion
• Secondary Interventions: 5%
– SMA stent for dissection
– Retroperitoneal bleeding, NAD on catheter angio
– Second attempt to cannulate renal artery
– Redilatation of renal artery stent
– SMA stent due to valley encroachment
30 day outcomes
• Mortality: 3%
– SMA dissection, failed endovascular salvage, patient died
– Peri-operative perforated gastric ulcer and multi-organ failure
– Stent graft thrombosis (infra-renal); ax-fem bypass
MOF
1 yr – Mortality (all cause) – 9%
• 3 deaths within 30 days
• 6 further deaths within 1 yr– 85 days post fEVAR, 1 day post CFA thrombectomy
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
1 2 3 4 5 6 7 8 9 10 11 12 13
Survival
TVP (88 pts – 4 pts had US follow-up)
• 30 days 99.6%
• 1yr 99.1% (silent renal artery occlusion)
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
0 1 2 3 4 5 6 7 8 9 10 11 12
• Migration (>5mm) 0%
• Type I/III endoleak 0%
• Renal function (>25%) 0%
• Freedom from secondary interventions – 90%
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
0.90
1.00
Sac size pre-op vs 1 yr
median change -11mm
decreased 67 76%stable 20 23%
99%
increased (>5mm) 1 1%
30
40
50
60
70
80
90
100
110
mm
• Highly effective to 1 yr
–30 day Mortality 3%
–1 yr TVP 99.1%
–Limb occlusion 0%
• 3 year data
• 2 centres only…
• 52/101 patients
Early results of fenestrated endovascular repair of juxtarenal aortic aneurysms in
the United Kingdom.British Society for Endovascular Therapy and the Global Collaborators on Advanced Stent-Graft Techniques for Aneurysm Repair
(GLOBALSTAR) Registry..
Circulation. 2012 Jun 5;125(22):2707-15. doi: 10.1161/CIRCULATIONAHA.111.070334.
Endovascular versus open repair of abdominal aortic aneurysm in 15-years' follow-
up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1): a randomised
controlled trial.Patel R, Sweeting MJ, Powell JT, Greenhalgh RM; EVAR trial investigators..
Lancet. 2016 Nov 12;388(10058):2366-2374. doi: 10.1016/S0140-6736(16)31135-7.
3 years - all cause mortality – 18%1 aneurysm related death
Elective open suprarenal aneurysm repair in England from 2000 to 2010 an
observational study of hospital episode statistics.Karthikesalingam A1, Holt PJ, Patterson BO, Vidal-Diez A, Sollazzo G, Poloniecki JD, Hinchliffe RJ, Thompson MM.
PLoS One. 2013 May 23;8(5):e64163. doi: 10.1371/journal.pone.0064163. Print 2013.
Median AAA sac size (mm)
0
10
20
30
40
50
60
70
1m 12m 24m 36m
3 yrs
0.00
0.20
0.40
0.60
0.80
1.00
Procedure 6 months 12 months 18 months 24 months 30 months 36 months
93% Freedom from AAA expansion
3 yearRe-interventionsTVP
SMA stent fracture
graft twist at primary implant
T2EL embolisation
1 TV lost
SMA
Conclusion
In a wide range of anatomy
52% not considered for OR
Many unsuitable for other fEVAR devices
Safe to implant 3% mortality
99.2% TVP
Effective to 1 year (& 3 years)
Low mortality
AAAs continue to shrink (better than conventional EVAR)
Low TV loss
Fenestrated Anaconda™: Experience in 101 cases in the UK
Robin WilliamsFreeman Hospital
Newcastle-upon-Tyne
Frances E Colgan a
Michael J Clarke a
Peter M Bungay b
John W Quarmby b
Nicholas Burfitt c
Alun H Davies c
Mike Jenkinsc
Andrew Hatrick d
David Gerrard d
a Freeman Hospital, Newcastle-upon-Tyne
b Royal Derby Hospital, Derby
c Imperial College, London
d Frimley Park Hospital, Frimley