Interventions

Interventions can be performed in cases where the conduit is not performing adequately. The following recommendations are made to avoid damage to the conduit.

 

Surgical access

  • Surgical access can be performed in the loop region of the aXess-L graft, after six (6) months post-implantation.
  • aXess-S cannot be accessed through the conduit.
  • When opening the conduit, do not cut the SRS struts.
  • When opening the conduit, it is recommended to use a scalpel blade (#11 or #15) instead of scissors to reduce the risk of cutting the SRS struts.
  • If needed, use pledgeted sutures when closing the conduit.
  • As an alternative, close the conduit incision with ePTFE sutures.

Percutaneous access

  • Access through inflow arterial branches or outflow venous branches is preferred per standard of care.
  • If required, percutaneous access through the conduit (both aXess-S and aXess-L) can be performed after six (6) months post implantation.
  • A guidewire is recommended when performing endovascular procedures within the conduit.
  • Use only atraumatic, soft-tipped guidewires when performing endovascular procedures within the conduit.
  • To reduce the risk of delamination or false lumen formation when performing endovascular procedures within the conduit, always use a atraumatic, soft-tipped guidewire and avoid using a super stiff guidewire and excessive force.
  • To reduce the risk of delamination or false lumen formation when performing endovascular procedures, check for proper positioning within the lumen using angiographic imaging and reposition guidewire if needed.
  • Catheter size 8Fr or smaller.

Angioplasty

  • Use only non-compliant balloons.
  • 7mm maximum balloon size.
  • Can be used at all conduit locations, including the anastomoses and loop region.
  • During the first six (6) months following implantation, avoid using a DCB (drug-coated balloon).

Stenting

  • Using self-expanding covered stents is recommended.
  • Refer to the manufacturer’s size recommendations (avoid undersizing and significant oversizing).
  • 7mm maximum balloon size for balloon-expanded stents.
  • Ensure a minimum 2 cm stent overlap with conduit SRS.
  • Can be used at all conduit locations, including the anastomoses and loop region.

Thrombectomy

  • Thrombectomy procedures should be performed within a few days after the onset of thrombosis while the thrombus is still soft, as per standard of care. This will reduce the risk of conduit delamination or false lumen creation.
  • Preferred method for surgical thrombectomy is using a 4 Fr Fogarty catheter, ideally over a guidewire. Do not use sizes above 6 Fr.
  • Preferred method for percutaneous thrombectomy is aspiration using the AngioJet™ system, size 6 Fr or similar.
  • Conduit can be clamped using an atraumatic clamp.
  • A second Fogarty catheter can be used as an endoclamp.
  • Commercially available endovascular thrombectomy devices based on aspiration can be used.
  • Using thrombolytic agents is acceptable after 6 months post-implantation.

Pseudoaneurysms

  • Covered stents are recommended for treating larger pseudoaneurysms, with a size of > 1.5cm in one dimension or an area of > 4cm².

Accessories

  • Introducer sheath: up to size 8Fr Max.
  • Guidewire: atraumatic, soft tip.