The present study demonstrated the feasibility of sheathless dTRA using an 8Fr BGC. Conversion to TFA was required in four of the 50 patients (8%). Of these four patients switched to TFA, the brachial artery could not be accessed because the BGCs were obstructed in the radial artery in two patients. In one patient, the diagnostic catheter could not select the target vessel, while in another patient, kinking occurred after the BGC was guided to the target vessel.
The efficacy of BGC has been well documented in prior studies [5, 8, 13, 16]. Indeed, one multicenter prospective study indicated that the use of BGC for mechanical thrombectomy is associated with a higher first-pass effect rate and reduced procedure time, leading to decreased National Institutes of Health Stroke Scale scores from admission to 24 h, and a lower 90-day mortality rate compared with non-BGC patients [7]. Furthermore, through flow control, BGC contributes to the navigability of microcatheters in the internal carotid artery, enhancing the stability of coils in anterior circulation aneurysms [17], [18]. In one retrospective study investigating coil embolization for anterior circulation aneurysms, proximal balloon inflation was used to stabilize the framing coil when it deviated from the parent vessel. In this study, flow control using a proximal balloon was performed in 43 of the 206 patients, and no procedure-related complications were observed [18]. Additionally, the use of BGC for flow reversal has been reported to facilitate safe treatment in CAS [5, 8, 13, 16]. In the present study, minor cerebral ischemia occurred as a complication of the procedure in two patients (4.7%). The use of BGC in neuroendovascular therapy was found to be effective with acceptable complication rates. Nevertheless, the small inner and large outer diameters of the BGC make it challenging to approach it through small-caliber vessels. Further, the double-lumen design is associated with trackability issues. Consequently, reports on dTRA using BGC are limited [5, 10]. Rajah et al. were the first to report mechanical thrombectomy using dTRA with a BGC [10]; in their study, they placed a 7Fr Glide sheath and guided a 6 + Cello Balloon Guide (Medtronic). Because of the small internal diameter, which could not accommodate 4Fr or 5Fr Simonds, the target vessel was selected with a glide wire, and the BGC was guided. However, this method was associated with a prolonged procedure times and anatomical limitations when approaching a target vessel. Additionally, concerns have been raised regarding the inability to perform emergency CAS due to the profile limitations of BGC. To guide large-bore BGCs, a sheathless access method can be utilized [13]. In one previously-reported case series, patients anticipating difficulties with TFA were selected, and a 9Fr Optimo was guided through the brachial artery without using a sheath for CAS [13]. Although kinking occurred in one of the eight patients, which necessitated a change of BGC, the procedure success rate was 100%, which necessitated a change in the BGC. Due to the lack of consideration of the radial artery diameter in this study, the BGCs became lodged in the radial artery in 2 out of 50 patients (4%). Guiding large-bore BGCs without using a sheath appears to be effective; however, it is necessary to consider the diameter of the radial artery.
Recently, BGCs with larger inner diameters that exhibit enhanced flexibility have been introduced [4, [14]. Flowgate 2 (Stryker Neurovascular, USA) has an outer diameter of 2.7 mm and an inner diameter of 0.084 in, and cannot accommodate a 0.071 inch large-bore aspiration catheter [4, 19]. In one retrospective study using an 8Fr Flowgate 2 for mechanical thrombectomy using TRA, radial artery vasospasm occurred in 3 of 20 patients, while kinking occurred in 4 patients [4]. In contrast, the Walrus (Q’Apel Medical, USA) has an outer diameter of 2.79 mm and an inner diameter of 0.087 in, allowing the use of a 0.071 inch large-bore aspiration catheter. Dossani et al. reported a case series of 10 patients with acute ischemic stroke due to large vessel occlusion treated with mechanical thrombectomy using a sheathless TRA with a Walrus BGC [14]. In this case series, TRA was achieved in all patients regardless of the radial artery diameter, while no kinking occurred. The 8Fr Optimo has an outer diameter of 2.67 mm, which is smaller than that of the Walrus. However, its inner diameter is 0.087 in, which is similar to that of the Walrus. The 8Fr Optimo can accommodate a 6Fr distal access catheter, enabling the use of a double microcatheter and a combination of a microcatheter and balloon in aneurysm treatment. In addition, CAS is possible. In our study, only 1 of 50 patients (2%) required TFA because of kinking of the internal carotid artery. Given its profile with a wide inner diameter, small outer diameter, trackability, and wide range of treatment options, sheathless dTRA using the 8Fr Optimo is considered a valuable treatment option.
In this retrospective study, sheathless distal radial access using an 8Fr BGC was performed regardless of radial artery diameter. Overall, we found that RAO occurred in 12 of the 43 patients (28%), and the radial artery diameter was significantly smaller in the occlusion group. Previous reports have indicated an occlusion rate of 0–5% with dTRA, whereas our study showed a higher RAO rate [5, 12, 20, 21]. In earlier studies, the choice of approach was left to the discretion of the physicians, and preoperative ultrasound was used to measure the vessel diameter and assess suitability [5, 12, 21]. Additionally, compared with our study, treatments using smaller sheaths may have resulted in lower occlusion rates [20]. Patient-related risk factors for RAO include female sex; diabetes mellitus; atherosclerotic factors such as dyslipidemia and peripheral arterial disease; small caliber of the radial artery; and repeated cannulation, which can cause intimal hyperplasia and media thickening, resulting in a reduced lumen diameter [11, 22]. Further, procedure-related risk factors, such as multiple punctures, radial artery spasm, long procedural and hemostasis times, and occlusive hemostasis have also been reported [11]. In a retrospective analysis of cardiovascular interventions performed via dTRA, a distal radial artery inner diameter-to-sheath outer diameter ratio of less than 1 was identified as an independent risk factor for distal RAO [12]. In our study, with a cutoff value for predicting RAO is 2.4 mm, this ratio was 0.92. According to previous findings, when employing large-bore BGCs for dTRA, careful consideration is necessary if the inner diameter of the radial artery closely matches the outer diameter of the sheath, which may result in radial artery occlusion.
RAO is usually asymptomatic [22], and severe hand ischemia is rare [23, 24]. Moreover, even if RAO occurs after a neuroendovascular procedure using TRA, retreatment may be possible. In one retrospective study involving 46 patients who underwent repeated TRA, RAO occurred in 13. Recanalization was achieved in a median of 6 days in all patients using a radial artery catheterization set that included the movable guidewire and outer sheath, allowing for subsequent neuroendovascular procedures [25]. Although symptomatic RAO was not observed in this study, in such cases, recanalization therapy may be required, and the artery becomes unusable for future access routes [24, 25]. Our indications for dTRA using an 8Fr BG may have the potential for improvement, considering a cutoff value of 2.4 mm for the inner diameter of the radial artery.
The present study has some limitations. First, patient data were collected retrospectively from a single institution. As such, further multicenter prospective studies are required to confirm these findings. Second, selection bias may have occurred as 120 patients requiring urgent treatment or with significant comorbidities were treated with TFA, most of whom underwent mechanical thrombectomy. In addition, seven patients switched their treatment to another access. As a result, only 43 patients treated with dTRA were analyzed. Finally, the study did not provide long-term follow-up results of patients who developed radial artery occlusion. Spontaneous recanalization can be observed, and a meta-analysis showed that the incidence of radial artery occlusion within 24 h was 7.7%, which decreased to 5.5% after more than 1 week of follow-up [12, 26]. Further follow-up is needed to assess the long-term RAO rates.