When to use standard EVAR with EndoAnchors or CHEVAR in short-neck AAAs JEAN-PAUL P.M. DE VRIES, DIRECTOR OF VASCULAR SURGERY ST.ANTONIUS HOSPITAL NIEUWEGEIN, THE NETHERLANDS. LINC ASIA-PACIFIC HongKong, March 2018 LINC ASIA 18
short neck is too simplistic 2
SWAC criteria aortic neck Short (< 15 mm) Wide (>28) Angulated (>75 infrarenal) Conical (>20% diameter increase first 1 cm) S in combination with WAC consequences for apposition of the endograft in the neck 3
Majority of endografts are tilted (in the neck) R.C. Schuurmann et al, JVS, 2017
EndoAnchors CREATE THE STABILITY OF A SURGICAL ANASTOMOSIS IN EVAR AND TEVAR Surgical Anastomosis EndoAnchoring Case images courtesy of John Aruny MD, Bart Edward Muhs, MD, PhD. 5
How to manage EVAR with EndoAnchors? PROPHYLAXIS TREATMENT Hostile Anatomy Overcoming concerns for implant stability Normal Anatomy Mitigating risk of reinterventions Resolve proximal seal failures Challenging neck anatomies (e.g. wide, short, conical, angulated) Severe comorbidities that preclude safe reintervention Targeted sealing of acute type I endoleaks Difficult landing Patients potentially lost during F/U Targeted sealing of late type I endoleaks (e.g. birdbeaking, close to branched vessels) Long remaining life expectancy (young pts) Augmented stability in migrated grafts Case image from Gandhi RT, Katzen BT Treating a Type 1A Endoleak Using EndoAnchors. Endovascular Today March 2012 23:26. 6
EVAR + EndoAnchors in short-necks Clinical Evaluation ANCHOR Registry Short Neck Cohort Baseline Anatomical Characteristics* Core Lab Anchor Registry Patients Infrarenal Diameter: 25.7 mm Primary Revision Neck Length: 6.86 mm ( 4.06-9.97 mm) Avg Neck Calcium Thickness: 1.31 mm Avg Neck Thrombus Thickness: 0.85 mm Endurant Stent Graft Other Brands Infrarenal Angulation: 20.6 Aneurysm Diameter: 70 Patients with Short Necks (<10 mm down to 4 mm) 57.7 mm * Mean Core Lab measurements
EVAR + EndoAnchors in short-necks ASA Classification ASA III/IV Male: 73% HTN Tobacco Female: 27% Hyperlipidemia CVD Mean Age: 71 Years 17.1% symptomatic patients Median Core Lab measurements based on 70 pts with baseline CTs 1. PMA P100021/S063: IFU Clinical Summary 2. CSR 2.9% ruptured cases
EVAR + EndoAnchors in short-necks Reasons for EndoAnchor placement (site-reported) SOURCE: Heli-FX CSR, 90 Day Update
EVAR + EndoAnchors in short-necks Procedure Duration (min) Time for EndoAnchor implant (min) Fluoro time (min) Number of EndoAnchor implants 148 17 35 5.5 *Average figures PMA P100021/S063: IFU Clinical Summary
EVAR + EndoAnchors in short-necks 1.9% (1/53) 1.6% (1/64) 4.7% (3/64) 0% (0/64) 0% (0/64) PROMISING 1-YEAR OUTCOMES Type Ia Endoleak Type Ia-Related Secondary Procedure Secondary Procedure Conversion to OSR Rupture PMA P100021/S063: IFU Clinical Summary
WHY CHEVAR? Custom made solutions still have limits
WHY CHEVAR? Approx. 18% of patients are excluded from EVAR because of a short neck with insufficient sealing zone Iliac access, neck angulation and emergent treatment are major exclusion criteria for custom made solutions J. Carpenter et. al; J Vasc Surg. 2001 Dec;34(6):1050-4
CH-EVAR IS A STANDARDIZATION NEEDED?
THE BEST CONDITIONS FOR PARALLEL STENTING DURING EVAR AN IN-VITRO STUDY ARE MATERIALS PLAYING A ROLE? Patency G. Mestres et. al, Eur J Vasc Endovasc Surg. 2012 Nov;44(5):468-73; 1 = MAQUET Cardiovascular, LLC
ARE MATERIALS PLAYING A ROLE? THE BEST CONDITIONS FOR PARALLEL STENTING DURING EVAR AN IN-VITRO STUDY Gutters G. Mestres et. al, Eur J Vasc Endovasc Surg. 2012 Nov;44(5):468-73
ARE MATERIALS PLAYING A ROLE? Patency PERICLES (Various Stent Grafts/Chimney stents) PROTAGORAS (Endurant +Advanta V12) 87.0% 95.7%
ARE MATERIALS PLAYING A ROLE? Nitinol Endoskeleton Gutters Stainless Steel Endoskeleton In vivo and in vitro studies showed harmonic interaction of the Endurant device with balloon expandable covered stents as chimneys. K. Donas et. al, J Vasc Surg. 2015 Sep;62(3):578-84
GUTTERS CLASSIFICATION A1 A2 A3 Type A1: Gutter originating at the proximal start of the fabric of the endograft and continuing into the aneurysm sac. Type A2: Gutter originating at the proximal start of the fabric of the endograft and extending into the side branch vessel. Type A3: gutter that begins at the proximal start of the endograft fabric and terminates proximal to the aneurysm sac or chimney stent graft
POTENTIAL PROS and CONS OF CHEVAR Advantages CE approved short neck indication Increases seal zone Off the shelf product availability Symptomatic, Ruptured Flexible Devices Angled Neck Low Profile Devices Challenging access vessels Cost effective Disadvantages Less wall apposition (gutters) Brachial access required
On-label use JUXTARENAL AAA - SEAL SMA Two Chimney ONLY Primary EVAR, no revision cases MINIMUM sealing zone 2mm Lowest Renal One Chimney For one Chimney: 15 mm from proximal aspect of AAA to highest renal Proximal Aspect of AAA For two Chimney: 15 mm from proximal aspect of AAA to SMA This must include a MINIMUM infrarenal neck of 2 mm (range 2 mm to 9 mm)
On-label use JUXTARENAL AAA - DIAMETER Aortic diameter treatment range 19 mm to 30 mm Oversizing recommendations 20 to 30% 19 mm to 30 mm Graft diameter (proximal; mm) Vessel inner diameter (mm) Standard configuration Parallel configuration 23 19-20 N/A 25 21-22 19-20 28 23-25 21-23 32 26-28 24-26 36 29-32 27-30
128 patients with pararenal pathologies and the intention to treat by Endurant and Atrium Advanta V12 1 as chimney graft Follow up: 3 year Kaplan Mayer analysis K. Donas et. al, J Vasc Surg. 2016 Jan;63(1):1-7
THE PROTAGORAS STUDY STUDY RESULTS Primary Endpoints: sac diameter regression and Chimney graft patency Sac regression: 64.8+/-14.6 mm 60.1+/-16.3 mm, p <0.001 New onset of type IA endoleak needed secondary procedure: 1.6 % 90,6 % patients reduced or stable AAA diameter K. Donas et. al, J Vasc Surg. 2016 Jan;63(1):1-7
Sufficient seal necessary Preoperative maximal PAP diameter 64.8 mm Preoperative proximal neck diameter 24 mm Preoperative proximal neck length 4.7 mm Preoperative suprarenal neck angulation 22.8 New sealing zone from <5mm to 18.7mm
THE PROTAGORAS STUDY PRIMARY CHIMNEY GRAFT PATENCY 95.7% K. Donas et. al, J Vasc Surg. 2016 Jan;63(1):1-7
THE PROTAGORAS STUDY REINTERVENTION 93.3% K. Donas et. al, J Vasc Surg. 2016 Jan;63(1):1-7
Extend the neck Stabilize the neck
Extend the neck Stabilize the neck
When to use standard EVAR with EndoAnchors or CHEVAR in short-neck AAAs JEAN-PAUL P.M. DE VRIES, DIRECTOR OF VASCULAR SURGERY ST.ANTONIUS HOSPITAL NIEUWEGEIN, THE NETHERLANDS. LINC ASIA-PACIFIC HongKong, March 2018 LINC ASIA 18