experimental & clinical cardiology

EXPERIMENTAL & CLINICAL CARDIOLOGY

Volume 20, Issue 7, 2014

Title: "Incidence and Predictors of Radial Artery Occlusion After Using Sheathless Standard Guiding Catheters in Complex Coronary Intervention and Carotid Artery Stenting by Trans-radial Approach"

Authors: Wei-Chieh Lee, Huang-Chung Chen, Chih-Yuan Fang, Cheng-I Cheng, Cheng-Hsu Yang, Chien-Jen Chen, Chi-Ling Hang, Hon-Kan Yip, Chiung-Jen Wu and Hsiu-Yu Fang

How to reference: Incidence and Predictors of Radial Artery Occlusion After Using Sheathless Standard Guiding Catheters in Complex Coronary Intervention and Carotid Artery Stenting by Trans-radial Approach/Wei-Chieh Lee, Huang-Chung Chen, Chih-Yuan Fang, Cheng-I Cheng, Cheng-Hsu Yang, Chien-Jen Chen, Chi-Ling Hang, Hon-Kan Yip, Chiung-Jen Wu and Hsiu-Yu Fang/Exp Clin Cardiol Vol 20 Issue7 pages 1305-1327 / 2014

Incidence and Predictors of Radial Artery Occlusion After Using Sheathless Standard Guiding Cat...

Incidence and Predictors of Radial Artery Occlusion after Using Sheathless Standard Guiding Catheters In Complex Coronary Intervention and Carotid Artery Stenting By Trans-Radial Approach

Wei-Chieh Lee, MD1, Huang-Chung Chen, MD1*, Chih-Yuan Fang, MD1, Cheng-I Cheng, MD1, Cheng-Hsu Yang, MD1, Chien-Jen Chen, MD1, Chi-Ling Hang, MD1, Hon-Kan Yip, MD1, Chiung-Jen Wu, MD1§, Hsiu-Yu Fang, MD1

1

Division of Cardiology, Department of Internal Medicine; Kaohsiung Chang Gung

Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung 83301, Taiwan

*Indicates equal contribution as first author. §

Indicates equal contribution as correspondence author.

Corresponding author: Hsiu-Yu Fang, MD Address for Correspondence: Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung 123, Ta Pei Road, Niao Sung District, Kaohsiung City, 83301, Taiwan, R.O.C. 1 Exp Clin Cardiol, Volume 20, Issue 7, 2014 - Page 1305


Address for Contact: No. 123, Ta Pei Rd, Niao-Sung District, Kaohsiung City, Taiwan Tel: +886-7-7317123 ext. 2363; +886-975056407 Fax: +886-7-7322402 E-mail: [email protected] Running title: Sheathless TRA for complex interventions

2 Exp Clin Cardiol, Volume 20, Issue 7, 2014 - Page 1306


Abstract Objectives The aim of this study was to evaluate the incidence and predictors of radial artery occlusion after using sheathless standard guiding catheters for complex coronary interventions and carotid artery stenting by trans-‐‑radial approach (TRA). Methods From January 2010 to June 2012, a total of 150 patients who received a sheathless TRA percutaneous coronary intervention (PCI) for complex coronary diseases such as chronic total occlusion (CTO), severe triple vessel coronary artery disease, left main coronary artery disease, and carotid artery stenting were enrolled. All of these patients underwent PCI using sheathless standard guiding catheters, and the procedural success and complication rates were recorded. Routine assessments of radial artery pulsation via clinical follow-‐‑up were done at 1 month, 6 months and 1 year after the procedure. Results Of the 150 patients, 117 received sheathless TRA PCI for complex coronary lesions, and 33 underwent a sheathless TRA intervention for carotid artery stenting. The access-‐‑related complication rate was only 2.6%, and the catheter-‐‑related complication rate was 13.0% due to difficulty with CTO lesions. The overall procedure success rate was 93.5% (complex coronary PCI: 92.3%; carotid artery stenting: 100%), and no patient required emergency surgery. After one-‐‑year follow-‐‑up, only 6 patients suffered from radial artery occlusion (RAO). The incidence of RAO for carotid artery stenting was higher than for complex coronary interventions (10.71% vs. 2.86%). Conclusions Sheathless transradial intervention for complex coronary artery disease and carotid artery stenting is feasible and safe with a relatively low RAO rate.



Key words Transradial, Sheathless, Percutaneous Coronary Intervention, Chronic Total Occlusion, Carotid Artery Stenting, Radial Artery Occlusion



Introduction Trans-‐‑radial approach (TRA) percutaneous coronary interventions (PCI) have been used since 1993 with increasing popularity. The feasibility and safety of TRA PCI has been reported for acute coronary syndrome (1), complex PCI (2, 3), carotid artery stenting (4), and even unprotected left main (LM) lesions (5). Although the larger size of the guiding catheters can offer a larger working space and stronger backup support, a higher rate of access site complication such as access site bleeding, hematoma and arterio-‐‑venous fistula formation can occur. In the current era, transradial coronary interventions result in fewer access site complications and a shorter duration of hospitalization. The retrograde approach via bypass grafting (6) and septal collaterals (7) is the most significant advantage of the PCI technique for chronic total occlusion (CTO), which requires larger guiding catheters for backup support and complex devices. One of the most important limitations of TRA PCI is the inability to use larger guiding catheters due to the relatively small size of the radial artery, especially in Asian patients. Saito et al (8) reported that the radial artery lumen is smaller than a 7 Fr introducer sheath in one third of men and two thirds of women in Japan. However, this critical limitation may be resolved by the sheathless guiding catheter technique with a 6.5 Fr sheathless guide catheter system (9). Several pilot studies have reported the use of sheathless standard guiding catheters for TRA PCI for bifurcation coronary lesions (10, 11). However, to the best of our knowledge, no study has evaluated sheathless standard guiding catheters for TRA interventions and carotid artery stenting with long-‐‑term follow-‐‑up of radial artery patency rate. Patients and enrollment criteria From January 2010 to June 2012, we prospectively enrolled 150 patients who received sheathless TRA PCI for complex coronary artery disease (CAD) PCI and carotid artery stenting. The hospital’s Internal Research Board committee approved the study protocol and each subject provided written informed consent.



Exclusion criteria The exclusion criteria included: 1) a history of acute or recent ischemic or hemorrhagic stroke (< 2 months); 2) major surgery or trauma within the preceding 2 months; 3) unfavorable anatomy for the transradial approach such as subclavian or innominate artery tortuosity and/or stenosis; and 4) positive Allen’s test in the arm. In total, 117 patients were enrolled who received complex CAD interventions, and 33 patients were enrolled who received carotid artery stenting. Four patients received sheathless TRA PCI twice for complex CAD PCI. Follow-‐‑up Routine assessments of radial artery pulsation via clinical follow-‐‑up with a pulse oximeter and Doppler ultrasonography scan were done at 1 month, 6 months and 1 year after the procedure. A total of 133 patients completed one year of follow-‐‑up, 10 were lost to follow-‐‑up, and 7 expired during the 1-‐‑year follow-‐‑up period. Sheathless guiding catheter insertion Both radial arteries were evaluated by either Allen’s test or Doppler ultrasonography before the procedure. A 5 Fr conventional arterial sheath (Terumo, Japan) was inserted via a usual radial artery access site with a 5 Fr standard guiding catheter for diagnostic coronary angiography or carotid angiography. A cocktail solution consisting of 200 µg nitroglycerin and 5,000 I.U. heparin was given via the artery sheath after successful sheath insertion. Before intervention, a 0.035 inch 260 cm J-‐‑tip Teflon wire (Argon, USA) was inserted to the ascending aorta. The 5 Fr artery sheath was then exchanged for a 6 or 7 Fr guiding catheter using the sheathless technique, which was loaded with a 5 Fr VTK catheter (VTK, Cook Inc., Bloomington, IN, USA). The guiding catheter was removed along with the J-‐‑tip Teflon wire after the procedure with a TR band (Terumo, Japan) (Figure 1 A-‐‑E) The guiding catheters used are listed in Table 1. Before performing PCI, a second intracoronary bolus of 5,000 I.U. heparin was administered via the guiding catheters. A loading dose of clopidogrel (300 mg)



was administered before PCI in all participants. Statistical analysis Continuous variables are reported as mean ± standard deviation, and categorical variables are reported as frequencies. Categorical variables were compared between groups by the chi-‐‑square test. A P-‐‑value of