Update on the fenestrated Anaconda endograft for F/EVAR: worldwide experience from the global FACT registry
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1 Update on the fenestrated Anaconda endograft for F/EVAR: worldwide experience from the global FACT registry Clark Zeebregts Professor of Vascular Surgery University Medical Center Groningen Department of Surgery Division of Vascular Surgery Groningen, The Netherlands
2 Disclosure Speaker name: Clark Zeebregts. I have the following potential conflicts of interest to report: Consulting (Terumo Aortic) Other(s): Received research grants from W.L. Gore & Associates, LeMaitre Vascular, Atrium Maquet Getinge Group, and Cook Medical
3 Concept Infra-renal sealing and fixation Peaks in anterior-posterior orientation Alignment markers on left valley Supra-renal fixation and sealing Valleys in AP orientation Vessel cradled in anterior valley Markers on left peak hook
4 Worldwide numbers Total implants to date: 2969 Data recorded January 18, 2019
5 AUI Bifurcated CFD Cuff Leg Implanted devices By type of device Straight Leg 9 By number of fenestrations Tapered Leg 69 Flared Leg 21 Extra Long Body 1 Tapered Cuff Straight Cuff Flared Cuff Extra Long Body Fenestrated Valley Long Body Standard 280 Short Body 36 Long Body 1018 Joined Bodies 268 Fenestrated Valley 173 Augmented Valley 647 Tapered AUI 21 Non-fen AUI 3 Fenestrated AUI 117
6 Literature Fenestrated Anaconda
7 Multicenter retrospective analysis - methods Retrospective cohort study All clinics worldwide >15 treated cases* Potentially >850 cases Primary outcome Re-intervention free survival Secondary outcome Survival Target vessel patency Procedural type Ia endoleak Follow-up results * The International Fenestrated Anaconda Study Group: P. Bungay, Royal Derby Hospital, Derby, UK; M.M. Sabalbal, R.S. Moore, Alberta Health Services Calgary, Canada; M. Delbridge, Norfolk and Norwich University Hospitals, UK; M.M.P.J. Reijnen, J.W. Lardenoije, Rijnstate Hospital, Arnhem, The Netherlands; K. Oikonomou, P. Kasprzak, Universitätsklinikum Regensburg, Regensburg, Germany; S. Mylonas, J. Brunkwall, University Hospital Cologne, Köln, Germany; R. Meerwaldt, R. Geelkerken, Medisch Spectrum Twente, Enschede, The Netherlands; A. Papaioannou, A. Stehr, Evangelisches Krankenhaus Mülheim, Mülheim an der Ruhr, Germany; C.J. Zeebregts, I.F.J. Tielliu, A. de Niet, UMCG, Groningen, The Netherlands; S. Langer, Marien-Hospital Witten, Witten, Germany; W.P. Ngu, R. Birk, R. Lakshminarayan, Hull and East Yorkshire Hospitals NHS Trust, Kingston upon Hull, UK.
8 Multicenter retrospective analysis - results 335 cases 11 centers (Netherlands, Germany, U.K., Canada) Median age 74 yrs M : F 292 : 43 egfr 67.6 ml/min/1.73 m 2 Procedural results General anesthesia 96.7% Cut-down access 91.6% Additional cranial access 42.0% Fenestrations 920 (mean 2.7) Value/% BMI 27.6 (±4.2) Hypertension (SVS 1) 79.1 Diabetes mellitus 19.7 Peripheral artery disease 20.9 Cerebrovascular disease 13.4 Hypercholesterolemia 64.8 Cardiac status (SVS 1) 47.3 Pulmonary status (SVS 1) 31.0 Smoker (yes + previous)
9 Multicenter retrospective analysis - early results Assisted primary technical success 88.4% Procedural type Ia endoleak 6.9% Type Ia endoleak at 30 days 2.5% Spontaneous resolved 56.5% Treated 4.3% egfr 65.2 ml/min/1.73m 2 vs. preoperative: p= day mortality 14 (4.2%)
10 Multicenter retrospective analysis - follow-up Follow-up Median follow-up all 1.2 yrs (IQR ) >30 days 1.4 yrs (IQR ) Re-intervention-free survival 1-yr 83.6 ± 2.2% 3-yrs 71.0 ± 3.7%
11 Multicenter retrospective analysis - follow-up Overall patient survival 1-yr 89.8 ± 1.8% 3-yrs 79.2 ± 3.0% Target vessel patency 1-yr 96.4 ± 0.7 % 3-yrs 92.7 ± 1.4% egfr 59.3 ml/min/1.73m 2 p=0.000, vs. pre-operative
12 Multicenter retrospective analysis - discussion Cases include first placed cases of the Fenestrated Anaconda Low technical success due to type Ia endoleak, but resolving spontaneously in most cases High target vessel patency at one year One-year survival is comparable to current literature Prospective registries or randomized trials still lacking
13 GLOBAL FACT multicenter prospective registry Study title Global Fenestrated Anaconda Clinical study Global FACT (FACT-001) Study type Global, multi-centre, prospective, non-interventional study of a custom device Sample size ~160 patients Maximum 25 cases per site 12 to 15 planned sites 2 year recruitment period 10 year follow-up
14 GLOBAL FACT multicenter prospective registry Currently 39 patients recruited in the study. 11 sites active (in Australia, Austria, Canada, Netherlands and UK).* Several other sites pending activation (in Italy, Germany and France). Primary data publications will occur at 1 year, 2 year, 5 year and 10 year endpoints. Initial publication (30 day data) anticipated Apr-Jun * The GLOBAL FACT study group N. Burfitt, London Imperial, London, UK; D. Gerrard, Frimley Park, Frimley, UK; R. Williams, J McCaslin, Freeman Hosptial, New Castle, UK; K. Sieunarine, Hollywood Medical Center, Perth, Australia; P. Chu, Epworth Richmond Hospital, Melbourne, Australia; R. Moore, Peter Lougheed Center, Calgary, Canada; J. Falkensammer, A. Assadian, Wilhelminnenspital, Vienna; M. Gargiulo, A. Stella, Policlinico S. Orsola Malpighi, Bologna, Italy; D. Midy, CHU Bordeaux, France; J. Brunkwall, Uniklinik Köln, Germany, M. Espinola, Hospital Dipreca, Santiago, Chili; MMPJ. Reijnen, Rijnstate, Arnhem, The Netherlands; A. de Niet, IFJ. Tielliu, CJ. Zeebregts, University Medical Center Groningen, Groningen, The Netherlands; R. Meerwaldt, Medisch Spectrum Twente, Enschede, The Netherlands; R. Kropman, Antonius Hospital, Nieuwegein, The Netherlands
15 Conclusions Acceptable mid-term results with Fenestrated Anaconda Possibility to treat different and more angulated anatomy Increased number of endoleaks, probably not relevant as most of them resolve spontaneously Long-term results are awaited
16 Announcement Thank you for your attention and welcome to ESCVS May 2019 in Groningen, The Netherlands!
17 Update on the fenestrated Anaconda endograft for F/EVAR: worldwide experience from the global FACT registry Clark Zeebregts Professor of Vascular Surgery University Medical Center Groningen Department of Surgery Division of Vascular Surgery Groningen, The Netherlands
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