Safety and feasibility of 5 French Glidesheath Slender for complex transradial interventions in small diameter radial arteries

Transradial(TR) access1, 2 has limitations in patients with small diameter radial arteries (SDRA) because of increased risk of radial artery(RA) spasm(RAS), access site crossover, procedure failure,³ and RA occlusion (RAO)⁴ despite adequate anticoagulation & patent hemostasis.1, 2

A wide variation in RA diameter (RAD)have been reported in patients worldwide: from 2.4 to 3.2 mm (SE Asia)3, 6, 7, 8, 9;1.8–1.9 mm (India)¹⁰;1.8–2.8 mm (North America).¹¹ RAD is ≤1.5 mm in 8–10% of our patients.¹⁰

The outer diameter of radial sheaths varies with manufacturers (≈2.4 mm for 5F sheaths and 2.7 mm for 6Fr sheaths).⁵ The Glidesheath Slender (GSS ™ Terumo, Japan) has a thinner wall, that reduces its outer diameter to 4Fr & has the potential to minimize RA: Sheath size mismatch, which is associated with higher risk of RAS and RAO especially in patients with SDRA.⁴

This non-randomized prospective study was performed on consecutive patients who presented to the Mission hospital Durgapur, India for coronary angiograms and/or angioplasty in July 2015 with the aim of assessing the safety and feasibility of the 5 Fr-GSS for complex coronary interventions in patients with SDRA using 5Fr guiding catheters.

All patients underwent ultrasound of arm arteries (UAA), to evaluate for internal diameters of bilateral RA and UA, cubital loops and vascular anomalies, to which the operators were blinded.

Consenting patients with right RAD <1.8 mm & coronary lesions of AHA/ACC type B2 or C¹² were included. The inclusion of patients with RAD <1.8 mm was based on prior data showing⁴ that these patients had greater post-procedure (PP) RAO.

Patients with RAD ≧1.8 mm, acute ST elevation myocardial infarction, those with thrombotic lesions requiring thrombo-suction (TRTS) or the presence of known bifurcation lesions with side branch >2 mm (SB2); calcific lesions requiring rotablation & those unable to consent were excluded.

Transradial intervention (TRI) was done using standard procedures via right radial access.¹⁰ PP- hemostasis was achieved by manual compression after sheath removal when the activated clotting time was <160 s. Average time to hemostasis was 18+/–7 min. UAA was repeated in patients¹⁰ at 0, 7 and 30 days PP to detect RAO.

Out of 19 consecutive patients, 9 met inclusion criteria {(Chronic total occlusion(n = 5),B2-lesions (n = 4)}; while 10 were excluded{TRTS (n = 3), SB2 (n = 2), Lesion A/B1 (n = 3), RAD > 1.8 mm (n = 2)}.

The mean RAD (1.6 ± 0.2 mm) in our cohort was smaller than those from prior observational studies.10, 11

PP-RAO occurred in one patient on day-0 with bilateral parallel RA and UA and high origin of the SDRA from the axillary artery. This patient also had intra-procedure grade 2 spasm.¹⁰

Another patient had a minor arm hematoma from injury by the tip of a 0.035” glidewire. This was contained by inflating a sphygmomanometer cuff.¹³

In one patient with a cubital loop, right radial access failed, necessitating access site change to left RA. In no case the GSS kinked or fractured.

Although this initial study is too small for any conclusions on RAO; we found the new 5 Fr GSS, to be safe and feasible in the patients with SDRA (<1.8 mm), who underwent complex TRI at our hospital without any major complications.