Venous Stents Placed Below the Inguinal Ligament: No Worries
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1 Venous Stents Placed Below the Inguinal Ligament: No Worries
2 Disclosure Speaker name: Lowell S. Kabnick, MD, FACS, FACPh, RPhS... I have the following potential conflicts of interest to report: Consulting: AngioDynamics, Amsel, Bard Scientific Advisory Board: Venclose Speakers Bureau: Boston Scientific Royalties: AngioDynamics
3 Disclosures I love steak I am not an engineer 3
4 Vs
5 About My Opponent Peter G The Master Magician
6 This is Not Magic or Illusions
7 Ladies and Gentleman Stenting across the inguinal ligament should be avoided. IS
8
9 Definition of the Word: Worry mental distress or agitation resulting from concern usually for something impending or anticipated : anxiety.
10 Shifting Gears
11 Stent Strength
12 Venous Stent Attributes Self-expandable Crush resistant across length of stent Sufficient chronic outward force Sufficient wall coverage Flexibility sufficient to resist kink at physiological angles Durability allowing repeated shortening, twisting, and bending at the groin Minimal foreshortening
13 Venous Stent Options (CE) Boston Wallstent Optimed Cook Zilver Vena VIVO Trial Veniti Vici VIRTUS Trial Optimed Sinus obliquus Sinus Obliquus- 01-NIS Bard Venovo VERNACULAR Trial Medtronic ABRE ABRE Clinical Study ongoing
14 Different venous stents for different locations High radial force Radial force plus flexibility non Flexibility, kink resistance, low fracture rate
15 Venous Stent Fracture: Early Learnings Causes are multifactorial Occurs more high flexion /torsion areas versus deep pelvis May be asymptomatic,, likely undetected with DUS (standard of care) follow-up Suspected Fracture Unless there is sequelae, typical follow-up likely to miss 15
16 Observed Fractures in Various Stent Designs by Multiple Modalities How is Fracture (Fx) detected? Cone beam CT Venogram Plain film X-ray IVUS Computed Tomography (CT) Scan Invaginated stent Fracture Fracture Fracture Fracture de Graaf R. Dedicated Venous Stents; 17 November 2015; New York, NY. DUS only valuable if patency impacted! 16
17 Stent Fracture Classification (Types) Non-coronary (arterial) types standardized Sequalae vary by stent design & application What does this classification system mean for venous fractures? 17
18 Fracture Occurs Most Often in Highly Mobile Locations Bending Axial (Compression/ Elongation) Radial s s max s a s a mean s min 2 0 First highlighted in SFA stenting and has similarities to venous
19 Iliofemoral Vein Segment Course of CIV to CFV under Inguinal Ligament/ over Superior Ramus result in complex radii, curvatures, and biomechanical loads 21
20 Peripheral Stent Fracture Well Described in Scientific Literature, Little in Regards to Venous Stents Fracture Contributors: Stent design/ materials Longer stents Stent overlap Areas of high motion Detection/ Impact/ Rate of Fractures: Restenosis/patency rates differ by stent design Many Fx never detected (observed incidentally) Formal approval trials have lower rates Commercial real-world use report higher rates C. Walker, Insert to Endovascular Today. September Fracture rates are from 1 st and 2 nd Gen SFA stents, contributors & impact trends similar 22
21 In SFA Arterial Stents, Fracture Rates and Resulting Clinical Impact vary by Design/Type & Use Critical Review of the Reported Stent Fracture Rates in the SFA, and Popliteal Artery, Pr Yann Gouëffuc, Department of Vascular Surgery Fractures alone do not predict in-stent restenosis Initial venous stent experience indicate many symptom free, some impact patency 23
22 Special Consideration: Inguinal Ligament A Concern? Stenting across the inguinal ligament should be avoided. Guidelines present risk/benefits Risks No data on venous stent fracture Increased risk of early in-stent stenosis Benefits Stenting down to a normal flow segment is more important than avoiding crossing the inguinal ligament. Stents should not overlap at/near inguinal ligament. 24
23 Compression at the Inguinal Ligament: Biomechanical Loads likely more complex than Bending Alone Quantification of crosssectional geometry metrics, including area, major axis, minor axis performed in cadaveric studies At fetal position, minor axis drops to 0, supporting the theory of compression at the At fetal position, minor axis inguinal ligament and pubis drops to 0, supporting the theory of compression at the inguinal ligament and pubis 25
24 Proximity of Vein to Superior Ramus: Could this be a Contributor to Fracture Risk in Certain Patients? Distance of Common Femoral Vein (CFV) to Superior Ramus varies among patients ( seen on CT, described in non-vascular scientific literature, as observed in cadaver studies) Varying CFV to Superior Ramus distances may lead to more deformation in some patients There is no conclusive data published to date, however this may be worth of further study to help predict patients at higher risk 26
25 If Luminal Diameter Is Maintained, Will Tissue Incorporation Minimize Clinical Sequelae? Potential Risks Due to Fx? Lumen compromise/ patency Intimal vein/tissue trauma Damage to neighboring organs Embolism/ Fragments of stents Migration Marston et al, Journal of Vascular Surgery Venous and Lymphatic Disorders. 2015; Vol.4, Issue 1:73-79 Rathore et al, Journal of Vascular Surgery Venous and Lymphatic Disorders. 2016; Vol.4, Issue 4: Does stent incorporation lead to reduced impact? 29
26 braided stainless stents can be safely placed in the venous system across the inguinal crease with no risk of: stent fractures narrowing due to external compression focal development of severe in-stent restenosis no effect on long-term patency
27 Conclusions Venous stent fracture understanding in infancy Fracture Risk Fractures occur in high flex areas vs. more stable pelvis Low coverage, More flexibility FEW VENOUS STENT FRACTURES HAVE BEEN REPORTED Physicians must consider disease coverage, placement in high risk areas, stent type selected and f/u surveillance 36
28 LADIES AND GENTLEMEN ARTERTIAL STENTS ARE NOT VENOUS STENTS ENGINEERING PROPERTIES ARE DIFFERENT NOT ALL VENOUS STENTS ARE THE SAME AT PRESENT THERE HAVE BEEN VENOUS STENT FRACTURES WITHOUT SEQUELLAE AS A RESULT OF THEIR ENGINEERING Physicians must consider disease coverage
29 YES, IT IS SAFE TO STENT UNDER THE LIGAMENT
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