How to select FEVAR versus EVAR + endoanchors in short-necked AAAs Jean-Paul P.M. de Vries, Richte C.L. Schuurmann St. Antonius Hospital Nieuwegein, The Netherlands 21st Critical Issues Congress Nuernberg, May 2017
Disclosures: Co-founder of Endovascular Diagnostics Consultant for Medtronic, Endologix Research grants: Cardionovum, BARD, Stichting Lijf en leven, Endologix, BTG
short neck is too simplistic 3
SWAC criteria aortic neck Short (< 15 mm) Wide (>28) Angulated (>75 infrarenal) Conical (>20% diameter increase first 1 cm) S in combination with WAC à consequences for apposition of the endograft in the neck 4
Custom software to calculate endograft position R.C. Schuurmann et al, JVS, in press
Majority of endografts are tilted (in the neck) R.C. Schuurmann et al, JVS, in press
Consequence for seal / apposition
Fabric distance from renal arteries R.C. Schuurmann et al, JVS, in press
Pre-operative neck post-op seal ü 45%: fabric distance 0 3 mm from renal artery ü 37%: > 3 mm below renal artery ü A 1 cm aortic neck at pre-operative CT scan = < 7mm seal post-evar (30% of patients)!
Factors influencing treatment (EVAR + / FEVAR) Team experience Budget / reimbursement Elective / urgent Logistics Patient characteristics 10
Why EVAR + Endoanchors? Custom made solutions still have limits 11
ANCHOR registry results ANCHOR Registry t Prospective, observation, international, multi-center postmarket registry to expand clinical knowledge on the use of Heli-FX EndoAnchor System in real-world patients 634* ANCHOR REGISTRY 462 PRIMARY ARM 172 REVISION ARM *Data cut November, 2016
ANCHOR registry (4 9 mm necks) ANCHOR Short Neck Cohort: N=70 subjects t Primary treatment with Endurant or Endurant II/IIs in conjunction with Heli-FX EndoAnchor System for infrarenal neck lengths 4mm and <10mm t Assessment of Primary Outcomes Type Ia endoleak rate (via Core Lab) Re-intervention rate Technical success
Baseline characteristics ( 4 9 mm necks) Endurant + EndoAnchor Implants Baseline Anatomical Characteristics* (N=70) Core Lab Infrarenal Diameter: 25.7 mm Infrarenal Angulation: 20.6 Neck Length: 6.86 mm Max Aneurysm Diameter: 57.7 mm Avg Neck Thrombus Thickness: 0.85 mm Avg Neck Calcium Thickness: 1.3 mm * Mean Core Lab measurements
Indications and procedural data Endurant + EndoAnchor Implants Reason for EndoAnchor Placement (site-reported) Concern for Late Failure 56% Treatment of Type Ia Endoleak 21% Prevention of Neck Dilatation 23%
Technical success Endurant + EndoAnchor Implants Technical Success: 88.6% (62/70) Successful delivery and deployment of the aortic stent graft, with no unintentional coverage of the renal arteries, and successful implantation of the EndoAnchor implants at the target aortic site At least 1 EndoAnchor didn t adequately penetrate aortic wall (N=4) All 4 procedures determined to be successful by the investigator Unsuccessful delivery of main body to intended landing zone (N=3) Endografts delivered slightly distal to intended target One subject with combination of low endograft landing, unintentional coverage of a renal artery with cuff, and unsuccessful implant of EndoAnchors Overall Procedural Success (investigator assessed): 97.1% (68/70)
30-days outcome Endurant + EndoAnchor Implants 1 Month Follow-Up Type Ia Endoleaks: 6.9% (4/58) 3 out of the 4 were not reported by the Sites; Core Lab reported 3 out of the 4 subjects received less than the recommended number of EndoAnchors implanted No AAA ruptures or conversions to OSR Two (2) subjects reported with limb occlusions Both subjects required 2nd procedures Mortality: 5.7% (4/70) Not device or AAA related
FEVAR Differences in number of fenestrations Differences in juxta-, para-, and suprarenal AAAs Differences in devices o Custom made, but manufactured o Physician modified
Meta-analysis (30-day mortality)
FEVAR outcome Author Year Type of study N = Peri-operative mortality Peri-operative renal impairment New-onset dialysis Reintervention rate Nordon 2009 Systemic review 368 1.4% 14.9% 1.4% 15% (12 mths) Linsen 2012 Systemic review 629 2.1% 22.2% 2.1% 18% (24 mths) Kristmundson 2009 Prospective series 54 3.7% 9% 0% 13% (12 mths) Greenberg 2009 Prospective series 30 0% 6.7% 0% 17% (24 mths) Verhoeven 2010 Retrospective series 100 1% 25% 2% 9% (24 mths) Tambyraja # 2011 Prospective series 29 0% n.a. 0% 38% (17 mths)
Meta-analysis, 2001-2012 5 CH-EVAR studies (94 patients, 151 target vessels) 10 F-EVAR studies (931 patients, 2465 target vessels) Target vessel preservation : 98.0% vs. 98.6% 30-day mortality : 5.3% vs. 2.4% Impaired renal function : 12% vs.9.8% New-onset dialysis : 2.5% vs. 1.5% Postoperative cardiac complications : 7.4% vs. 3.7% Ischemic stroke : 3.2% vs. 0.3% p=0.012 EARLY type Ia ELs : 10% vs. 4.3% p=0.002
Short necks (4-9 mm) à EVAR + Endoanchors EndoAnchors + Endurant provide an off-the-shelf solution for short neck, hostile anatomy patients to improve fixation This therapeutic approach preserves future treatment, if needed. Use of EndoAnchors + Endurant does not preclude future use of proximal cuff, chevar, fevar, or OSR Early outcomes have demonstrated the importance of following IFU recommendations for number of EndoAnchor implants to use Further follow-up required, but early treatment success is high given the challenging patient characteristics of this 4 to <10mm short neck cohort Indications: patients declined for FEVAR and open surgery, urgent AAA repair, cost/benefit considerations
Short necks (4-9 mm) à FEVAR Possibility to extend seal (ideally > 15 mm circumferential apposition) Proven concept with robust mid-term data No single of double FEVAR, but 3 or 4 vessel FEVAR
Short necks treatment algorithm Treatment options are complementary Patient tailored decision Don t forget open surgery