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Aminian A - AIMRADIAL 2013 - Glidesheath slender


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Initial experience with the Glidesheath Slender for transradial coronary angiography and intervention: a feasibility study with prospective radial ultrasound follow-up

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Aminian A - AIMRADIAL 2013 - Glidesheath slender

  1. 1. Initial experience with the Glidesheath Slender for Transradial Coronary Angiography and Intervention: a Feasibility Study with Prospective Radial Ultrasound Follow-up. Adel Aminian, MD, Dariouch Dolatabadi, MD, Pascal Lefebvre, MD, Robert Zimmerman, MSc, Philippe Brunner, MD, Georges Michalakis, MD, Jacques Lalmand, MD Centre Hospitalier Universitaire de Charleroi Belgium
  2. 2. Disclosures • I have no relevant financial interests to disclose
  3. 3. Background • Increasing use of TR access worldwide • Radial artery: smaller size and increased tendancy to spasm • 6Fr guide catheters are standard for PCI cases 1 1 Bertrand OF et al. JACC CI 2010; 3:1022–1031.
  4. 4. 6Fr Saito et al. CCI 1999
  5. 5. GLIDESHEATH “SLENDER” CONCEPT GLIDESHEATH “SLENDER” CONCEPT OD 2,63 mm ID 2,22 mm OD 2,45 mm Down Sizing ID 2,22 mm Equivalent Diameter 5Fr Sheath
  6. 6. GLIDESHEATH “SLENDER”: POTENTIAL BENEFITS GLIDESHEATH “SLENDER”: POTENTIAL BENEFITS • 1size down puncture Minimize invasiveness • 1 size up inner lumen Time and cost saving in ad-hoc PCI
  7. 7. GLIDESHEATH “SLENDER”: SPECIFIC CAUTIONS GLIDESHEATH “SLENDER”: SPECIFIC CAUTIONS Terumo t=0.20mm ETFE Terumo t=0.15mm ETFE Terumo t=0.10mm(Trial sample) ETFE Behaviors after the tube was folded at 180° With permission from Terumo
  8. 8. Objectives • To evaluate the feasibility and safety of the Glidesheath Slender in routine transradial (TR) coronary angiography and intervention.
  9. 9. Methods
  10. 10. TR procedures • Verapamil (2mg) and Isosorbide Dinitrate (200400 μg) • IV Heparin 5000 UI – PCI: Adjunctive bolus for ACT 250-300 • 4 or 5 French for diagnostic and 5 or 6 French for PCI
  11. 11. Postprocedural hemostasis • TR band • Strict patent hemostasis protocol • Compression time limited to 2H
  12. 12. Study end-points • Primary endpoint: – Procedural success. • Secondary endpoints: – Vascular access site complications – Symptomatic vascular spasm – Major sheath kinking – Post-procedural radial artery occlusion (RAO).
  13. 13. End-points definitions • Procedural success – Completion of the planned procedure through the initially selected radial access route. • Vascular access site complications – Any documented vascular damage (vessel perforation, arterial dissection, pseudoaneurysm and local hematoma). – Major: hemoglobin loss > 3 g/dl or need for blood transfusion or vascular repair. – Minor: local hematoma > 3 cm diameter without hemoglobin loss > 3 g/dl or need for blood transfusion or vascular repair.
  14. 14. End-points definitions • Symptomatic vascular spasm – Inability to manipulate the guidewire or catheter in a smooth and pain-free manner – Inability to remove the sheath in a similar way at the end of the procedure. – The presence of vascular anatomical variants was also recorded. • Major sheath kinking – Significant deformation of the sheath leading to vascular complication and/or procedural failure. • Post procedural RAO – The absence of a radial pulse assessed clinically together with the absence of flow assessed by Doppler ultrasound examination of the radial artery at 1 month follow-up
  15. 15. 1 full 360° Radio-ulnar loop 2 severe RA tortuosities
  16. 16. High procedural success • 99% PCI through single radial access without sheath upsizing • All comer population – ACS patients – Complex PCI
  17. 17. Low rate of post-procedural RAO • Reduced sheath size • Adequate anticoagulation • First TR procedure • Limited compression time • Strict patent hemostasis protocol
  18. 18. RAO SV. JACC CI 2012
  19. 19. SPECIFIC SETTINGS AT INCREASED RISK OF SHEATH KINKING SPECIFIC SETTINGS AT INCREASED RISK OF SHEATH KINKING • Resistance to sheath insertion – Short skin nick – Push the sheath carefully • During attempts to replace the sheath in case of slippage. – Adhesive dressing
  20. 20. Conclusions • Routine use of the Glidesheath Slender for TR coronary angiography and intervention is safe and feasible with a high rate of procedural success and low rates of vascular complications and RAO. • This new dedicated radial sheath has the potential to allow complex coronary interventions while limiting local trauma to the artery. • Future studies will need to compare the Glidesheath Slender with current 6Fr sheaths with focus on vascular access site complications and RAO.