Update On Fevar: Sciencedirect

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journal of indian college of cardiology 6s (2016) 128–131

Available online at www.sciencedirect.com

ScienceDirect

journal homepage: www.elsevier.com/locate/jicc

Short Communication

Update on FEVAR

Saroj Das *
Professor, Department of Vascular Surgery, London North West Hospitals NHS Trust, London, UK

article info abstract

Article history: Synopsis of presentation at APVIC VII, June 2015.


Received 23 August 2015 # 2015 Indian College of Cardiology. All rights reserved.
Accepted 26 October 2015
Available online 30 November 2015

Keywords:
FEVAR
Anaconda
Juxtarenal
Pararenal

and efficacy of the device. This is a requirement from MHRA for


1. Introduction
vigilance of custom devices. The patient population included
those who required a custom-made AAA device for juxtarenal
Management of juxtarenal and pararenal aortic aneurysm aneurysms. The follow-up included clinical assessment,
frequently presents a challenge. Open surgery for this measurement of renal function and CT/ultrasound at pre-
condition is associated with devastating consequences. discharge or 30 days (if still hospitalised) and every year post-
Endovascular approach has been developed by some of the implant till 5 years. The endpoints were adverse events,
device industries with better short- and long-term results. This overall mortality, AAA exclusion and target vessel patency.
is a Post-Market Surveillance Study for the Vascutek Custom
Fenestrated Anaconda Stent Graft. Vascutek joined the
3. Results
Fenestrated programme in June 2010.

By the end of May 2015, a total of 968 devices were implanted


2. Methods
world-wide, of which 307 were deployed in UK and 231 in
Germany (Table 1). Two-third of the patients were hyperten-
This is a web-based prospective multicentre observational sive, 40% had ischaemic heart disease, 22% had chronic renal
post-market registry with the aim of monitoring clinical safety impairment and 9% had previous aortic surgery (Table 2).

* Tel.: +44 1895279847; fax: +44 1895259249.


E-mail address: saroj.das@imperial.ac.uk
http://dx.doi.org/10.1016/j.jicc.2015.10.008
1561-8811/# 2015 Indian College of Cardiology. All rights reserved.
journal of indian college of cardiology 6s (2016) 128–131 129

Table 1 – Total Anaconda stent graft implants by country.

Forty-four patients were unfit for open surgery. The maximum


Table 2 – Patient demographics and reported comorbid- diameter of the aneurysms was a mean of 62  11 mm. 451
ities. patients had 2, 314 patients had 3 and 137 patients had 4
Reported comorbidities N % fenestrations (Table 3). Bifurcated grafts were deployed in 584
(94.7%) of the 617 patients. Operating time in minutes was as
Diabetes 91 14
follows: screening 69  46, procedure time 288  114 (Tables 4
Hypertension 410 65
Current smoker 143 23 and 5). With regard to adverse events, 14 patients had cardiac
Ex smoker 229 36 events, 10 had renal complications, 8 patients suffered a stroke
Ischaemic heart disease 254 40 and limb ischaemia occurred in 4 patients. The overall
Congestive cardiac failure 57 9 mortality was 9.2% (57/618). Endoleaks were reported in 170/
Chronic renal impairment 137 22 612 evaluable patients at the end of the procedure, and Type II
Cerebrovascular disease 57 9
accounting for majority of the endoleaks, reducing to 1 (Type
Prior aortic surgery 53 9
II) at the end of 4 years. Aneurysm sac size had decreased in all
 Age: Mean  SD: 74  7 years (N = 618); Range: 51–97 years.
the evaluable patients (Table 6). Target vessels were lost in 11/
 Sex: 557 male (89%) (N = 628).
803 vessels at the end of 1 year (Table 7).

Table 3 – Number of fenestrations.

Number of Fenestraons

5 4

4 137

3 314

2 451

1 52

0 6

• Devices are fully customised and can have 0 to 5 fenestraons

• Approximately 80 % of Fenestrated Anaconda™ devices have 2 or 3 fenestraons.


130 journal of indian college of cardiology 6s (2016) 128–131

Table 4 – Procedure times.


Statistic Value
Screening time (min) Mean  SD 69  46
N = 600 Median 62
Min 0
Max 336

Procedure time (min) Mean  SD 292  123


N = 597 Median 269
Min 58
Max 1045

Procedure time adjusted (removing 4 outliers >12 h) (min) Mean  SD 288  114
N = 593 Median 265
Min 58
Max 671

Table 5 – Graft data.


Graft type Total (N = 617) Number of fenestrations

0 1 2 3 4 5
Bifurcate 584 (94.7%) – 33 292 193 65 1
Cuff 20 (3.2%) 1 – 8 7 4 –
AUI 11 (1.8%) 1 – 5 5 – –
Leg 2 (0.3%) 2 – – – – –

Table 6 – Outcomes: Aneurysm sac size.


1 year (N = 261) 2 years (N = 66) 3 years (N = 16) 4 years (N = 3)
Decreased 166 (63.6%) 32 (48.5%) 7 (43.8%) 3 (100%)
Stable 83 (31.8%) 29 (43.9%) 7 (43.8%) 0
Increased 12 (4.6%) 5 (7.6%) 2 (12.5%) 0

Table 7 – Outcomes: Target vessel patency.


1 year (N = 250) 2 years (N = 65) 3 years (N = 15) 4 years (N = 3)
Target vessels 803 217 52 12
Fully patent 766 201 49 12
Partially occluded 26 14 2 0
Occluded 11 2 1 0
Vessels lost 9 renal artery 2 renal artery 1 renal artery –
1 SMA
1 Coeliac

4. Conclusions suggested readings

The 5 years global registry data for FEVAR Anaconda 1. Greenberg RK, Haulon S, Lyden SP, et al. Endovascular
experience is encouraging with an overall mortality of 9.2% management of juxtarenal aneurysms with
and low adverse events despite a large proportion of the fenestrated endovascular grafting. J Vasc Surg.
patients being unsuitable for open surgery. 2004;39:279–287.
2. Forbes TL, Harding GE, Lawlor DK, Derose G, Harris KA.
Comparison of renal function after endovascular
Conflicts of interest aneurysm repair with different transrenally
fixated endografts. J Vasc Surg.
2006;44:938–942.
The author has none to declare.
journal of indian college of cardiology 6s (2016) 128–131 131

3. Greenhalgh RM, Brown LC, Powell JT, et al. Endovascular 6. Sandford RM, Bown MJ, Sayers RD, Fishwick G, London NJ,
versus open repair of abdominal aortic aneurysm. N Engl J Nasim A. Endovascular abdominal aortic aneurysm repair:
Med. 2010;362:1863–1871. 5-year follow-up results. Ann Vasc Surg. 2008;22:372–378.
4. Faruqi RM, Chuter TA, Reilly LM, et al. Endovascular 7. Sun Z, Mwipatayi BP, Semmens JB, Lawrence-Brown MM.
repair of abdominal aortic aneurysm using a Short to midterm outcomes of fenestrated endovascular
pararenal fenestrated stent-graft. J Endovasc Surg. 1999;6: grafts in the treatment of abdominal aortic aneurysms: a
354–358. systematic review. J Endovasc Ther. 2006;13:747–753.
5. Monahan TS, Schneider DB. Fenestrated and branched stent 8. Muhs BE, Verhoeven EL, Zeebregts CJ, et al. Mid-term results
grafts for repair of complex aortic aneurysms. Semin Vasc of endovascular aneurysm repair with branched and
Surg. 2009;22:132–139. fenestrated endografts. J Vasc Surg. 2006;44:9–15.

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