A Aminian

Akihiko Takahashi

DN Feldman

E Romagnoli

F Kiemeneij

F Yoshimachi

Ferdinand Kiemeneij

Fuminobu Yoshimachi

HC Gwon

ME Wewers

Motomaru Masutani

S Saito

S Schulman

SS Jolly

T Fujii

T Matsukage

Takashi Matsukage

Yuji Ikari

Abstract
          The aim of this study was to evaluate the safety and feasibility of the new 5 Fr Glidesheath Slender (GSS). The transradial (TR) approach has become popular because of several advantages, such as a reduced rate of vascular access site complications. However, because the radial artery is narrow, a limitation of TR access is the potential for artery spasm or occlusion. Studies of radial artery size demonstrate that 5 Fr sheaths are too wide for more than 10 % of patients. The GSS (Terumo, Tokyo, Japan) is a new radial sheath with a thinner wall and a hydrophilic coating. It has an inner diameter that is compatible with a 5 Fr guiding catheter, while the outer diameter is similar to that of a 4 Fr sheath. A total of 21 consecutive patients undergoing transradial angiography and/or transradial percutaneous coronary intervention with the 5 Fr GSS were included, and safety and feasibility of the device were assessed. Transradial angiography was performed in 10 patients, and transradial intervention in 11 patients. All procedures were successful, without the need for conversion to the transfemoral approach. The radial artery occlusion rate was 0 %, including a patient who had experienced six previous radial artery punctures. There were no cases of artery spasm, hematoma, major bleeding or functional disorders. One coronary artery perforation caused by a guidewire was reported, but it was unrelated to the sheath introducer. The new 5 Fr GSS was safe and feasible for transradial angiography and transradial intervention.</jats:p

Crossref

ORIGINAL ARTICLESafety and feasibility of the new 5 Fr Glidesheath SlenderFuminobu Yoshimachi1 • Ferdinand Kiemeneij2 • Motomaru Masutani3 •Takashi Matsukage4 • Akihiko Takahashi5 • Yuji Ikari1Received: 11 March 2015 / Accepted: 23 June 2015 / Published online: 4 July 2015 Japanese Association of Cardiovascular Intervention and Therapeutics 2015Abstract The aim of this study was to evaluate the safetyand feasibility of the new 5 Fr Glidesheath Slender (GSS).The transradial (TR) approach has become popular becauseof several advantages, such as a reduced rate of vascularaccess site complications. However, because the radialartery is narrow, a limitation of TR access is the potential forartery spasm or occlusion. Studies of radial artery sizedemonstrate that 5 Fr sheaths are too wide for more than10 % of patients. The GSS (Terumo, Tokyo, Japan) is a newradial sheath with a thinner wall and a hydrophilic coating. Ithas an inner diameter that is compatible with a 5 Fr guidingcatheter, while the outer diameter is similar to that of a 4 Frsheath. A total of 21 consecutive patients undergoing tran-sradial angiography and/or transradial percutaneous coro-nary intervention with the 5 Fr GSS were included, andsafety and feasibility of the device were assessed. Transra-dial angiography was performed in 10 patients, and tran-sradial intervention in 11 patients. All procedures weresuccessful, without the need for conversion to the trans-femoral approach. The radial artery occlusion rate was 0 %,including a patient who had experienced six previous radialartery punctures. There were no cases of artery spasm,hematoma, major bleeding or functional disorders. Onecoronary artery perforation caused by a guidewire wasreported, but it was unrelated to the sheath introducer. Thenew 5 Fr GSS was safe and feasible for transradialangiography and transradial intervention.Keywords Glidesheath Slender  Less invasivetreatment  Slender percutaneous coronary intervention Transradial angiography  Transradial coronaryinterventionIntroductionTransradial angiography (TRA) and transradial coronaryintervention (TRI) have become popular approachesbecause of several advantages, such as fewer bleedingcomplications [1–3]. However, use of TRA and TRI islimited for patients with a narrow radial artery, beingassociated with the risk of artery spasm, occlusion or pain.Indeed, the 6 Fr sheath size is too big for some patients.The outer diameter of a 5 Fr sheath may also be too widebecause radial artery studies demonstrate that a 4 Fr sheathis optimal for the majority of patients [4, 5].Glidesheath Slender (GSS, Terumo, Japan) is compati-ble with a 5 Fr guiding catheter and it was designed solelyfor TR access. All the 5Fr Guiding Catheters, which we canuse in Japan 2015, are compatible with the 5Fr GSS thatwas already checked in vitro. It has a thinner wall, whichreduces the outer diameter by 1 Fr, while the diameter ofthe inner lumen is unchanged (Fig. 1). The length of the5Fr GSS is 16 cm. Aminian et al. reported the safety andfeasibility of the 6 Fr GSS [6]. In this study, initial expe-rience with the 5 Fr GSS (4 Fr outer diameter) was eval-uated in patients undergoing TRA and TRI, focusing onsafety and feasibility.& Fuminobu Yoshimachiyoshimachi-circ@umin.ac.jp1 Department of Cardiology, Tokai University School ofMedicine, 143 Shimo Kasuya, Isehara, Kanagawa 259-1193,Japan2 Tergooi Hospital, Blaricum, The Netherlands3 Department of Cardiology, Syowa Hospital, Amagasaki,Japan4 Department of Cardiology, Tokai University HachiojiHospital, Hachioji, Japan5 Takahashi Hospital, Kobe, Japan123Cardiovasc Interv and Ther (2016) 31:38–41DOI 10.1007/s12928-015-0344-2MethodsTRA or TRI using the GSS 5 Fr was performed in TergooiHospital, the Kingdom of the Netherlands, on two con-secutive days in January 2015. Patients were enrolledprospectively, not randomized. The inclusion criterion(Fig. 2) was suspected or confirmed ischemic heart diseaserequiring coronary angiography or percutaneous coronaryintervention (PCI) via the radial artery. Ad hoc PCI wasplanned for all patients, and preoperative administration ofdual antiplatelet drugs was mandatory. Exclusion criteriawere as follows: no indication for coronary angiography orPCI, less than 21 years old, females with the possibility ofpregnancy, unable to obtain written informed consent, andpatients whom the physician deemed to be unsuitable forthis study.Only procedures using the 5 Fr GSS were included. Theapproach was via either the right or left radial arterybecause the GSS is approved exclusively for radial arteryaccess.After local anesthesia, puncture with 21-gauge needleswas performed, the guide wire was inserted, and the 5 FrGSS was placed inside the radial artery. All patientsreceived 5000 IU of heparin, irrespective of the scheduledprocedure. The decision to perform ad hoc PCI after TRAwas made by each physician.Following procedure completion, the 5 Fr GSS wasimmediately removed, and hemostasis was performed witheither TR-Band (Terumo, Japan) or a bandage and smallpillow, as selected by the physician. TR-band was removed4–5 h after confirmation of bleeding cessation, whilebandages were removed after the overnight hospital stay.End pointsThe primary endpoint was radial artery patency afterremoval of hemostasis devices, and pulsation was com-pared with that before the procedure. For cases with nopulsation or a low level of pulsation, radial artery patencywas determined with the pulse Doppler method.Secondary endpoints were: radial artery spasm, hema-toma, major bleeding complication, functional disorderincluding hand ischemia due to radial artery dysfunction,pain score, and major adverse cardiac and cerebrovascularevents (MACCE) related to the GSS. Radial Spasm wasdefined clinically as significant limitation of the cathetermovement felt by the operator with severe pain in theforearm of the patient.MACCE was defined as: all-cause mortality, cardiacdeath, myocardial infarction, cerebral bleeding, cerebralinfarction, or acute revascularization.Pain was assessed after sheath removal using the visualanalog scale (VAS) [7], with scores ranging from 0 to10 cm. Large hematoma was defined as more than 5 cm orequal to 5 cm in diameter, and small hematoma as lessthan 5 cm. Major bleeding was defined as fatal bleeding,and/or symptomatic bleeding in a critical area or organ,and/or bleeding accompanied by either a decline inhemoglobin levels of greater than or equal to 20 g L-1(1.24 mmol L-1) or the need for a transfusion of greaterthan or equal to 2 units of whole blood or red blood cells[8].Fig. 1 The novel introducer sheath of the 5 Fr Glidesheath Slender has an inner lumen the same size as a conventional 5 Fr sheath, combinedwith an outer diameter similar to that of a conventional 4 Fr sheath. The artery access size is 1 Fr lower than that of a conventional 5 Fr sheathFig. 2 5Fr GC was inserted to the 5Fr GSS via right radial approach.However, common color of 5Fr sheath is gray; the color of the 5FrGSS is red which is for common 4Fr sheath. Because outer diameterof the 5Fr GSS is the same as that of conventional 4Fr sheathSafety and feasibility of the new 5 Fr GSS 39123ResultsThe clinical characteristics of patients are presented inTable 1. A total of 21 patients were included, of whom85.7 % were male. The mean age was 61.5 ± 13.6(mean ± SD) years, and the mean body mass index was26.6 ± 3.8 kg/m2. The mean number of previous attemptsat radial artery access was 0.85, and the maximum was six.Ad hoc PCI was performed after TRA in 11 patients,while the other 10 patients underwent TRA only. The meanprocedure time was 24.1 ± 9.2 minThe results of primary and secondary endpoints areshown in Table 2. No cases of radial artery occlusion wereobserved. In one patient who had undergone radial accesssix times previously, pulsation was very weak from thebeginning of the procedure, and no change was detectedafter TR-Band removal; as a result, patency was assessedwith the pulse Doppler method.DiscussionThis is the first report of clinical experience with the 5 FrGSS. No cases of radial artery occlusion or spasm, and nobleeding complications were reported in this study. VASscores were very low, indicating that the sheath had a lowpropensity to cause pain. It should be noted that neitherradial artery occlusion nor spasm occurred in a patient whohad undergone TR access six times previously. The outerlumen of the 5 Fr GSS is the same as that of a conventional4 Fr sheath; however, 5 Fr catheters were used in thisstudy, and the results are similar to those observed with 4Fr conventional sheaths.Nevertheless, it was a concern that the thinner wall ofthe GSS may be prone to kinking or fracture, but no suchphenomenon occurred.It is well known that the use of a sheath with a largerdiameter than that of the radial artery causes injury.Reducing the sheath size from 5 Fr to 4 Fr is associatedwith safer TR access, with the rate of vascular access sitecomplications reduced by up to 5 and 15 % in Japanesemales and females, respectively [4, 5]. It is expected that asimilar level of risk reduction may be achieved with the 5Fr GSS. Another study reported that a sheath with a smallerouter diameter was more comfortable for patients, and thethreshold ratio of radial artery/sheath outer diameter was0.9, even in cases without radial artery occlusion andpainful feelings using a conventional 5 Fr sheath [9]. Forthese reasons, TR access is safer and more comfortablewith the 5 Fr GSS than conventional 5 Fr sheaths.Recently, the introduction of next-generation deviceshas made it possible to use 5 Fr guiding catheters forroutine PCI. All the available stents are compatible with a5 Fr guiding catheter. Furthermore, the kissing balloontechnique can be performed with a 5 Fr guiding catheterand 0.010 in. guide wire for bifurcation lesions [10]. PCIfor chronic total occlusion is also possible [11]. Severaltechniques to enhance back-up support have been intro-duced for complex lesions, including a child’s catheter[12].Limitations of this study include the small number ofcases, single ethnic origin of the Netherlands, and the useof two different hemostasis devices. Especially, Nether-lander is well known for strong constitution of the bodyand the size of radial artery may be larger than that ofAsian race. We need more studies to other race includingTable 1 Patients’ characteristics (n = 21)Age (years) 61.5 ± 13.6 (35–91)Male gender (%) 18 (85.7)Height (cm) 174 ± 9.1Weight (kg) 64.0 ± 14.5BMI (kg/m2) 26.6 ± 3.8Coronary risk factor, n (%)Hypertension 11 (52.4)Dyslipidemia 9 (42.8)Diabetes 6 (28.6)Insulin treated 2 (9.2)Current smoker 10 (47.6)Number of previous radial access, n (%)0 10 (47.6)1 8 (38.1)2 2 (9.5)6 1 (7.8)Procedure (%)Angiography 10 (47.6)Ad hoc PCI 11 (52.4)Procedure time (min) 24.1 ± 9.2BMI body mass index, PCI percutaneous coronary interventionTable 2 Results of the primary and secondary endpointsPatency after removal of hemostasis devices (%)Patency 21(100.0)Radial artery occlusion 0Spasm 0Major and minor hematoma 0Major bleeding 0Functional disorder 0Pain score 0.57 (0.0–3.0)MACCE 0MACCE: all-cause mortality, cardiac death, myocardial infarction,cerebral bleeding, cerebral infarction, or acute revascularizationrelated to the Glidesheath Slender40 F. Yoshimachi et al.123Asian, who have small sized radial artery. Because thissmall size of the sheath seems to be useful to people havingsmall sized radial artery to prevent radial artery occlusionor spasm. The selection of hemostasis devices by thephysicians was not random. The TR-Band was mainlyselected for one-day outpatient procedures because of thelack of overnight nursing staff with experience using thishemostasis device. Further studies are necessary to evalu-ate the 5 Fr GSS in Asian populations, which have a higherbleeding tendency.This sheath has thin wall. In this study, there were nokinking and bending phenomenon after using angiographyand intervention. But we have to know that GSS may befragile with manipulating violently and have to be usedgently to disturb breaking.Finally, limitation of this report should be described.Using the echography and the doppler flow may clarify theimpact of the 5Fr GSS on radial artery. But it was difficultto use those imaging devices, because the hospital disal-lowed to use it. This is the first in men of 5Fr GSS. Weshould make another multi center registration comparingwith 5Fr GSS and conventional 5Fr sheath in order toprove the superiority of slender sheath.ConclusionThe initial clinical experience with the new 5 Fr GSSdemonstrated that it was safe and feasible for TR access.No radial artery occlusion or spasm was reported. Thebleeding complication rate was also 0 %.Acknowledgments We wish to thank all the members of TergooiHospital who provided help with this study, and all members of theSlender Club Japan for contributing to the concept of a slender sheath.Conflict of interest All authors must disclose any affiliation with orfinancial involvement in any organization with a direct financialinterest in the subject matter or materials discussed in the manuscript.References1. Feldman DN, Swaminathan RV, Kaltenbach LA, Baklanov DV,Kim LK, Wong SC, et al. Adoption of radial access andcomparison of outcomes to femoral access in percutaneouscoronary intervention: an updated report from the national car-diovascular data registry (2007–2012). Circulation.2013;127:2295–306.2. Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versusfemoral access for coronary angiography or intervention and theimpact on major bleeding and ischemic events: a systematicreview and meta-analysis of randomized trials. Am Heart J.2009;157:132–40.3. Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, RigattieriS, Pendenza G, et al. Radial versus femoral randomized investi-gation in ST-segment elevation acute coronary syndrome: theRIFLE-STEACS (Radial versus femoral randomized investiga-tion in ST-Elevation acute coronary syndrome) study. J Am CollCardiol. 2012;60:2481–9.4. Fujii T, Masuda N, Toda E, Shima M, Tamiya S, Ito D, et al.Analysis of right radial artery for transradial catheterization byquantitative angiography–anatomical consideration of optimalradial puncture point. J Invasive Cardiol. 2010;22:372–6.5. Saito S, Ikei H, Hosokawa G, Tanaka S. Influence of the ratiobetween radial artery inner diameter and sheath outer diameter onradial artery flow after transradial coronary intervention. CatheterCardiovasc Interv. 1999;46:173–8.6. Aminian A, Dolatabadi D, Lefebvre P, Zimmerman R, Brunner P,Michalakis G, et al. Initial experience with the GlidesheathSlender for transradial coronary angiography and intervention: afeasibility study with prospective radial ultrasound follow-up.Catheter Cardiovasc Interv. 2014;84:436–42.7. Wewers ME, Lowe NK. A critical review of visual analoguescales in the measurement of clinical phenomena. Res NursHealth. 1990;13:227–36.8. Schulman S, Kearon C. Definition of major bleeding in clinicalinvestigations of antihemostatic medicinal products in non-sur-gical patients. J Thromb Haemost. 2005;3:692–4.9. Gwon HC, Doh JH, Choi JH, Lee SH, Hong KP, Park JE, et al. A5Fr catheter approach reduces patient discomfort during tran-sradial coronary intervention compared with a 6Fr approach: aprospective randomized study. J Interv Cardiol. 2006;19:141–7.10. Yoshimachi F, Masutani M, Matsukage T, Saito S, Ikari Y.Kissing balloon technique within a 5 Fr guiding catheter using0.010 inch guidewires and 0.010 inch guidewire-compatibleballoons. J Invasive Cardiol. 2007;19:519–24.11. Matsukage T, Masutani M, Yoshimachi F, Takahashi A, KatsukiT, Saito S, et al. A prospective multicenter registry of 0.010-inchguidewire and compatible system for chronic total occlusion: thePIKACHU registry. Catheter Cardiovasc Interv.2010;75:1006–12.12. Kiemeneij F, Yoshimachi F, Matsukage T, Amoroso G, Fraser D,Claessen BE, et al. Focus on maximal miniaturisation of tran-sradial coronary access materials and techniques by the SlenderClub Japan and Europe: an overview and classification. EuroIn-tervention. 2015;10:1178–86.Safety and feasibility of the new 5 Fr GSS 41123

Cardiovascular Intervention and Therapeutics

Safety and feasibility of the new 5 Fr Glidesheath Slender

https://link.springer.com/content/pdf/10.1007%2Fs12928-015-0344-2.pdf

Safety and feasibility of the new 5 Fr Glidesheath Slender

Abstract

Similar works

Full text

Available Versions

Crossref