Initial Experience With a Novel Sheathless Guiding Catheter (Hyperion SheathLess) for Transradial Coronary Intervention

Abstract

Background. The Hyperion SheathLess guiding catheter (Asahi Intecc) is a novel guiding system for transradial percutaneous coronary intervention (PCI). Compared with the previous model (SheathLess Eaucath; Asahi Intecc), improvements achieved with the Hyperion SheathLess catheter are a more flexible tip and a smaller outer diameter of the catheter while maintaining the diameter of the inner lumen. The aim of this study was to report our initial experience with this guiding catheter. Methods. A total of 127 consecutive patients undergoing transradial PCI using a 6-Fr Hyperion SheathLess guiding catheter (n = 78) or a 7-Fr catheter (n = 49) were analyzed. Results. Procedural success was 99.2%, with 1 patient (0.8%) requiring conversion to femoral access. No patients were noted to have coronary ostial dissection. Doppler ultrasound examination of the radial artery at 30-day follow-up was available in 111 of 127 patients, with 3 patients (2.7%; all 3 patients in the 7-Fr catheter group) found to have radial artery occlusion. Radial spasm occurred in 3 patients (2.4%; all 3 patients in the 7-Fr catheter group). Forearm hematoma occurred in 10 patients (7.9% total; 4 grade-1 patients [3.2%], 5 grade-2 patients [3.9%], and 1 grade-3 patient [0.8%]). Conclusion. The use of the Hyperion SheathLess guiding catheter for transradial PCI was feasible and associated with a low rate of procedure-related complications, including coronary ostial dissection. This sheathless guiding catheter could be a valuable option to further decrease the risk of procedure-related complications.

Keywords: sheathless guiding catheter, slender device, transradial approach

Radial access complications, such as radial artery occlusion (RAO) and radial spasm, limit the use of the radial approach for percutaneous coronary intervention (PCI), despite the clinical benefits in reducing vascular access-site and bleeding complications.¹ The SheathLess Eaucath guiding catheter (Asahi Intecc) was previously developed to overcome such drawbacks by removing the need for traditional sheaths.² However, transradial PCI using a sheathless guiding catheter has not yet gained popularity, and its adoption has been limited to only a few experienced radial centers,³ which is largely attributable to a concern about the risk of catheter-induced coronary ostial dissection because of its tip stiffness.^4,5 For this reason, the Hyperion SheathLess guiding catheter (Asahi Intecc) has recently been developed as a next-generation sheathless guiding catheter for PCI. As compared with the previous model, SheathLess Eaucath, improvements achieved with the Hyperion SheathLess catheter are a more flexible tip, which is made of soft urethane, and a smaller outer diameter of the catheter while maintaining the diameter of the inner lumen. In this study, we report our preliminary results on the feasibility and safety of performing transradial PCI using this new sheathless guiding catheter system.

Methods

Patient selection. During the study period, the choice of access site and type of guiding system was left to operator discretion. A total of 127 consecutive patients underwent transradial PCI using a 6- or 7-Fr Hyperion SheathLess guiding catheter at Sendai Kousei Hospital between November 2018 and July 2021. No patients were excluded from the analysis. Consequently, a total of 127 patients undergoing transradial PCI using a 6-Fr or 7-Fr Hyperion SheathLess guiding catheter were analyzed in our study.

The 6-Fr Hyperion SheathLess guiding catheter combines an inner diameter of 1.80 mm, which is 6-Fr compatible, with an outer diameter of 2.11 mm, which is smaller than that of a 6.5-Fr Sheathless Eaucath guiding catheter (2.16 mm) or a 5-Fr sheath (2.30-2.35 mm) and is almost the same size as the 4-Fr sheath (2.00-2.10 mm), whereas the 7-Fr Hyperion SheathLess guiding catheter combines an inner diameter of 2.05 mm, which is 7-Fr compatible, with an outer diameter of 2.41 mm, which is smaller than that of a 7.5-Fr SheathLess Eaucath guiding catheter (2.49 mm) or a 6-Fr sheath (2.60-2.65 mm) (Figure 1).

PCI procedures and radial hemostasis. Using the Seldinger technique, the radial artery was punctured about 2 cm proximal to the radius styloid process with 18-G puncture needles, and a 0.025˝ guidewire was introduced, reaching the ascending aorta. A short dilator or a peel-away dilator, followed by a sheathless guiding catheter connected to a supplied central dilator, was introduced into the radial artery over a 0.025˝ guidewire (Figure 2). Once the sheathless guiding catheter reached the proximal ascending aorta and coronary intubation was achieved, the central dilator and 0.025˝ guidewire were removed. In cases in which ad hoc PCI procedures were performed, a sheath-cum-sheathless technique was used. Namely, after coronary angiography was performed with a 4-Fr sheath via the radial artery, the sheath was exchanged for a sheathless guiding catheter over a 0.025˝ guidewire. The initial dose of heparin was 7500-10,000 units. After the sheathless guiding catheter was removed at the end of the procedure, the punctured radial artery was sealed with a compression device (Tometa Kun; Zeon Medical)⁶ according to the following steps to achieve hemostasis (occlusive hemostasis technique). First, it was pressurized up to the reference pressure, defined as ≥20 mm Hg pressure than the systolic blood pressure at the time of catheter removal. Next, 30 minutes after removal, the pressure was decreased by 20 mm Hg every hour until it reached 20 mm Hg, if the hourly checkup revealed no local hematoma or bleeding. Finally, the compression device was removed 7-8 hours after the procedure.

Ultrasound evaluation. We evaluated the incidence of RAO at 30-day follow-up using Doppler ultrasonography with the Toshiba Aplio XG SSA-790A (Cannon Medical Systems Corporation) and a PLT-1204AT (2D, 12 MHz) or a PLT-1204BT (2D, 12 MHz) probe. The sheath-to-artery ratio was defined as the ratio between the outer diameter of the sheathless guiding catheter (2.11 mm for 6 Fr and 2.41 mm for 7 Fr) and the inner diameter of the radial artery measured before PCI.

Study endpoints and definitions. The efficacy outcome was procedural success, which was defined as the successful completion of transradial PCI by achieving postprocedural thrombolysis in myocardial infarction (MI) grade 3 flow and <30% coronary residual stenosis without crossover to another form of vascular access. Safety outcomes were as follows: (1) coronary ostial dissection while navigating the guiding catheters into the coronary ostium; (2) access-site complications during the procedure or at 30-day follow-up, including RAO, radial spasm, radial pseudoaneurysm requiring intervention (percutaneous or surgical), and forearm (access-site) hematoma; (3) major bleeding, including procedure-related bleeding complications and blood loss from a hemostasis valve Y connector; and (4) major cardiac and cerebrovascular events (MACCEs) during the 30 days post procedure, including all-cause death, MI, stent thrombosis, target lesion revascularization, and ischemic stroke. RAO was defined as severely reduced or absent blood flow at the puncture site, as revealed by Doppler studies.⁷Radial spasm was defined as intolerable pain experienced by the patient or difficulty reported by the operator during the insertion, manipulation, or removal of the sheathless guiding catheter. Forearm hematoma was categorized using the early discharge after transradial stenting of coronary arteries grading:⁸ grade 1, <5 cm in diameter; grade 2, 5-10 cm in diameter; grade 3, >10 cm in diameter but distal to the elbow; and grade 4, extending above the elbow. Major bleeding was evaluated based on the definition provided by the Bleeding Academic Research Consortium.⁹ We included type 3 and type 5 events as the safety outcomes in the current study.

Statistical analysis. Continuous variables are expressed as median (interquartile range [IQR]) and categorical variables are expressed as numbers and percentages. We compared categorical variables using Fisher's exact test. Because of the descriptive nature of the study, we did not perform a formal sample-size calculation. A 2-tailed P-value of <.05 was considered statistically significant. All statistical analyses were performed using JMP software, version 14 (SAS Institute, Inc).

Ethics approval. The study was approved by the institutional research committee of the Sendai Kousei Hospital (approval No. 2-9; approval date: May 12, 2020). All procedures performed in this study were conducted in accordance with the ethical standards of the institutional research committee and the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Results

Baseline patient characteristics are presented in Table 1. The median age of the patients was 71.0 years (IQR, 62.0-79.0), and 53.5% underwent PCI for stable angina pectoris. Table 2 outlines the procedural characteristics. A total of 108 patients (85%) underwent PCI using 1 guiding catheter without exchanging for another. Of the 19 patients who required >1 guiding catheter, 18 required a change of the guiding catheter for a larger or smaller size when navigating the catheter into the coronary ostium, and 1 patient required another guiding catheter due to crossover to transfemoral PCI using a conventional sheath. No patients required catheter exchange due to poor backup support. Among the 78 patients who underwent preprocedural radial artery ultrasound examinations, the median value of the sheath-to-artery ratio was 0.96 (IQR, 0.84-1.10).

Table 3 shows the efficacy and safety outcomes. Procedural success was 99.2%. Access-site crossover occurred in 1 patient (0.8%). In this patient, crossover to femoral access was required because a peel-away dilator was accidentally pushed too deep into the left radial artery. It got stuck and could not be removed manually. Thus, radial access became impossible, and crossover to femoral access was performed. The peel-away dilator was surgically removed after transfemoral PCI was completed. No patients experienced catheter-induced coronary ostial dissection during the procedure. A total of 111 patients underwent radial ultrasound at 30-day follow-up; 3 patients (2.7%) had RAO, all of whom underwent PCI with a 7-Fr Hyperion SheathLess guiding catheter. Three patients (2.4%) underwent radial spasm, although it did not hinder the completion of PCI. All patients were free from MACCE at up to 30 days after the index PCI, except for 2 patients who died from cardiac failure 3-4 hours after PCI for myocardial infarction and 1 patient who developed ischemic stroke 1 hour after PCI. Table 4 shows the incidences of access-site complications and major bleeding according to the size of the sheathless guiding catheter. No patients treated with a 6-Fr Hyperion SheathLess guiding catheter experienced RAO or radial spasm. Compared with the patients who underwent PCI with a 6-Fr Hyperion SheathLess guiding catheter, those who underwent PCI with a 7-Fr catheter had a significantly greater incidence of forearm hematoma (grade ≥1) (odds ratio (OR), 4.17; 95% confidence interval [CI], 1.02-16.97) and major bleeding at 30-day follow-up (OR, 10.74; 95% CI, 1.25-92.20).

Discussion

To the best of our knowledge, the current study is the first to focus on the feasibility and safety of using a 6-Fr or 7-Fr Hyperion SheathLess guiding catheter for transradial PCI. The main findings showed a low rate of procedure-related complications, including catheter-induced coronary ostial dissection.

We found no cases of catheter-induced coronary ostial dissection in our study. This may be attributed to the more flexible tip of the Hyperion SheathLess guiding catheter compared with the previous model, whose incidences of catheter-induced coronary ostial dissection were reported to be 1.0%-1.8%.^4,5 Thus, the more flexible tip of the Hyperion Sheathless guiding catheter could encourage interventional cardiologists to use this novel catheter in their daily clinical practice.

Additionally, the 6-Fr Hyperion SheathLess guiding catheter presented no incidence of postprocedural RAO at 30 days as determined by ultrasonography, whereas the 7-Fr catheter showed a nonsignificant but numerically higher incidence of RAO (7%). This might be because the outer diameter of the 6-Fr Hyperion SheathLess guiding catheter is almost the same as a 4-Fr sheath. The larger sheath-to-artery ratio is a significant predictor of RAO;⁷ a sheath that is larger than a radial artery is likely to cause RAO (the sheath-to-artery ratio cutoff for RAO is 1.0) and the outer diameter of even a 5-Fr sheath was reported too large for most Asian populations.⁷ Therefore, a 4-Fr sheath size may be most suitable for Asian populations, who have small-sized radial arteries.^10,11 In our study, the median value of the sheath-to-artery ratio in the 6-Fr group was 0.92 (<1.0), which indicates that the use of this next-generation sheathless catheter avoided a large sheath-to-artery mismatch. As expected, no patients who received the 6-Fr Hyperion SheathLess guiding catheter experienced RAO. Previously, the incidence of RAO was 11.6% with a 6-Fr conventional sheath and 19.5% with a 7-Fr conventional sheath.¹² Thus, this novel sheathless guiding system, the 6-Fr size in particular, contributed to the much lower incidence of RAO than that expected from previous data of PCI (using conventional sheaths).

Only a few patients experienced radial spasm, according to our findings. In particular, it did not occur in patients who underwent PCI with a 6-Fr Hyperion SheathLess guiding catheter. This indicates that this next-generation sheathless catheter avoided a large sheath-to-artery mismatch, as a sheath-to-artery ratio >1 is associated with pain during sheath insertion and removal.¹³ In fact, in the present study, the median value of the sheath-to-artery ratio for the 6-Fr Hyperion SheathLess guiding catheter was 0.92. In addition, the hydrophilic coating that is present along the entire length of the catheter might also have contributed to the low incidence of radial spasm.

Forearm hematoma after transradial sheathless PCI occurred in 7.9% of the patients in our study. Numerically, this is almost the same as the previous data using sheaths (mostly 5-Fr or 6-Fr sheaths).⁸ In addition, the findings of our study suggest that a larger-bore guiding catheter is more likely to cause forearm hematoma or major bleeding, which is consistent with a previous meta-analysis demonstrating that the use of a 6-Fr system was associated with a significant increase in bleeding events compared with a 5-Fr system.¹⁴ Thus, we must recognize that forearm hematoma could happen even if transradial sheathless PCI is performed, and when choosing a large-bore sheathless guiding catheter, close follow-up of both access site and hemoglobin level is warranted.

Study limitations. Our study had several limitations. First, this was a retrospective, observational study, and thus, no direct comparison has been made with the previous model. Second, because the choice of the Hyperion SheathLess guiding catheter was at operator discretion, we cannot rule out a selection bias. Finally, more data are required to confirm whether this novel catheter is really feasible in more complex PCI cases, which generally take longer. In prolonged PCI procedures, we must recognize the reduction of maneuverability and backup of the sheathless guiding catheter due to the heat and moisture of the blood. Therefore, additional studies are needed to evaluate this sheathless guiding catheter in more complex PCI cases.

Conclusion

Our initial experience with the novel Hyperion SheathLess guiding catheter for transradial PCI found that its use was feasible and associated with a low rate of procedure-related complications, including catheter-induced coronary ostial dissection. This new sheathless guiding system could be a viable option for further reducing the risk of procedure-related vascular complications in transradial PCI.

Acknowledgments. We would like to thank Ai Maruyama, Shizuka Nishimagi, and Saori Ichijyo at Sendai Kousei Hospital for helping with the work and data collection.

Affiliations and Disclosures

From the ¹Department of Cardiology, Sendai Kousei Hospital, Sendai, Miyagi, Japan; and ²Department of Cardiovascular Medicine, Dokkyo Medical University, Mibu, Tochigi, Japan.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.

Manuscript accepted October 21, 2021.

The authors report that patient consent was provided for publication of the images used herein.

Address for correspondence: Tsuyoshi Isawa, MD, Department of Cardiology, Sendai Kousei Hospital. 4-15, Hirose-machi, Sendai, Miyagi, 980-0873, Japan. Email: isa_tsuyo@yahoo.co.jp

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