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. 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. Disclosures • I have no relevant financial interests to disclose
- 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. 6Fr Saito et al. CCI 1999
- 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. 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. 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. Objectives • To evaluate the feasibility and safety of the Glidesheath Slender in routine transradial (TR) coronary angiography and intervention.
- 9. Methods
- 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. Postprocedural hemostasis • TR band • Strict patent hemostasis protocol • Compression time limited to 2H
- 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. 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. 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
- 17. 1 full 360° Radio-ulnar loop 2 severe RA tortuosities
- 18. High procedural success • 99% PCI through single radial access without sheath upsizing • All comer population – ACS patients – Complex PCI
- 19. Low rate of post-procedural RAO • Reduced sheath size • Adequate anticoagulation • First TR procedure • Limited compression time • Strict patent hemostasis protocol
- 20. RAO SV. JACC CI 2012
- 21. 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
- 22. 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.
Notes de l'éditeur
- Over the last decade, the transradial (TR) approach for coronary angiography and interventions has become popular throughout the world because of several advantages such as reduced bleeding complications and immediate patient mobilisation . On the other hand, the smaller size of the radial artery together with an increased tendency to spasm may potentially restrict the use of large-sized sheaths and catheters that are necessary for the treatment of complex coronary lesions. Despite these few limitations, a recent international TR practice survey has demonstrated that the use of 6 French (Fr) guide catheters was the standard for most PCI cases
- However, the use of a 6Fr sheath may create a significant mismatch between the sheath and the radial artery in a substantial number of patients leading to vascular complications (9,10).
- The Glidesheath « Slender » from Terumo (Tokyo, Japan) has been developed as a 6 Fr compatible radial sheath with hydrophilic coating and a thinner wall than current 6 Fr sheaths, with the goal to minimize invasiveness during TR approach (Fig 1). For this purpose, the thickness of the sheath wall has been reduced from 0,20 mm to 0,12 mm, while maintaining an ID of 2,22 mm (Figure 2a and 2b). As a result, the OD has been reduced from 2,63 mm to 2,45 mm which is close to the OD of current 5Fr sheath
- Potential benefits of this sheath during TR procedure include a reduced risk of damage to the radial artery and the possibility to perform most PCI cases in ad-hoc procedure
- Since UTW has thinnest sheath wall, it is easier to kink than current sheaths. However, it easy to kink, but also easy to come back to original position and resistance of device insertion is not impaired.
- In case of successful insertion of the Glidesheath Slender, a drug cocktail of Verapamil (2mg) and Isosorbide Dinitrate (200-400 μg) was injected through the side arm of the sheath. Heparin (5000 IU) was given intravenously in all patients. Diagnostic procedures were performed using 4 or 5 Fr catheters. In case of PCI, a 5 or 6 Fr guiding catheter was chosen according to operator preference and lesion complexity. An adjunctive bolus of Heparin was given during PCI if needed according to activated clotting time monitoring (therapeutic range 250-300 sec). Administration of glycoprotein IIb-IIIa inhibitors and/or Bivalirudin depended on the discretion of the operator.
- After removal of the sheath, hemostasis was achieved using a unilateral radial compression system (TR Band; Terumo, Tokyo, Japan) in order to achieve “patent hemostasis” in all patients. Briefly, the TR Band was initially inflated at the site of radial puncture with 10 cc of air to facilitate removal of the sheath. Radial artery patency was then evaluated by plethysmography during manual compression of the ipsilateral ulnar artery. In case of occlusive compression of the radial artery, the TR Band was gradually deflated till the plethysmographic signal returned, which confirmed radial artery patency. Special care was taken to achieve the lowest pressure necessary to maintain hemostasis. Radial compression time was limited to a maximum of 2 hours for both diagnostic and PCI procedures.
- The mean age was 63 +/- 11 years and 74 patients were male (65%). Of the 114 cases, 27 patients had acute coronary syndrome (24%) with 10 patients undergoing primary PCI.
- Access was obtained through the right radial artery in 112 patients (98,2%) and through the left radial artery in 2 patients. During the procedure, the use of at least one 6 Fr catheter was noted in 38 patients (34%). Ad-hoc or planned PCI was performed in 35 patients (31%). In case of PCI, a 6 Fr guide catheter was required for the treatment of bifurcation lesions in 16 patients with subsequent kissing balloon inflation in 13 patients, the use of a thromboaspiration catheter in 9 patients and the use of rotational atherectomy in 2 patients. At the end of the procedure, failure to achieve patent hemostasis occurred in only 2 patients (1,7%).
- Procedural success was 99,1% with only one case requiring conversion to femoral access. In this case, the reason for procedural failure was the presence of an abnormal implantation of the right coronary ostium with an inability to engage a guide catheter by right radial access. There were 6 minor hematomas but no patient experienced major vascular complications. The rate of symptomatic radial spasm was 4,4% (5/114). In 3 out of the 5 patients who developed spasm, upper-limb retrograde angiography disclosed anatomical variations (2 patients had severe radial tortuosities and 1 patient had a full 360° radial-ulnar loop). No case of major sheath kinking was noted. Doppler ultrasound examination of the radial artery at 1 month follow-up was available in 113/114 patients with only one case of RAO (0,88%).
- Of note, all PCI except one could be performed through a single radial access without the need for upsizing the sheath with subsequent reduction in patient discomfort and radial injury related to sheath exchange. Furthermore, we used the Glidesheath Slender in an all-comer population including patients presenting with ACS and patients undergoing complex PCI.
- Besides reduced sheath size, several other factors can explain the low rate of RAO found in this study including adequate anticoagulation (5000 IU Heparin) in all patients, exclusion of patients with previous TR procedure through the same artery, limited compression time up to 2 hours and most importantly the achievement of a strict « patent hemostatis » protocol with only 2 patients requiring occlusive compression of the radial artery in order to achieve post-procedural hemostasis.
- Of note, the low rate of radial occlusion found in our study is in line with previous studies using a patent hemostasis protocol (RAO between 0,8 and 1,8%) (19, 21-22). Along with these studies, we demonstrated that prevention of RAO can be achieved by the combination of best current clinical practice and reduced sheath size.
- In our experience, 2 specific settings are at increased risk of developping sheath kinking: 1/ during sheath insertion and 2/ during attempts to replace the sheath in case of slippage. If a resistance to sheath insertion occurs at the level of the skin, we recommend to perform a short skin nick and to push the sheath carefully. Following successfull insertion, the sheath should be fixed to the forearm at the point of entry into the radial artery with an adhesive dressing to avoid slippage during the procedure.
- Only 2 patients requiring occlusive compression of the radial artery in order to achieve post-procedural hemostasis