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Success Rate and Safety of Coronary Angiography and Angioplasty Via Radial Artery Approach Among a Chinese Population
Abstract: Objective. To find out the safety and success rate of transradial coronary angiography and angioplasty among a Chinese population. Design. This was a prospective study performed on 2845 consecutive patients in a single interventional center at the first affiliated hospital, Nanjing Medical University, in Nanjing from August 2012 to July 2013. Allen’s test was carried out on all patients who were involved in the study. Patients with abnormal Allen’s test, cardiogenic shock, those on hemodialysis, and foreigners were excluded from the study. Our goal was to determine the efficacy and complications of coronary angiography (CAG) and percutaneous coronary intervention (PCI) through the radial approach in our local population. Results. The mean age of our patients was 64 ± 7.5 years with 1628 males (57.2%) and 1217 females (42.8%). A total of 1537 patients (54.0%) were hypertensive, while 501 patients (17.6%) were diabetic. Six patients (0.002%) had previous coronary artery bypass surgery. None of our patients had any bleeding disorder. A total of 1416 CAGs (49.8%) and 1429 PCIs (50.2%) were performed. The success rate was 97.6% for CAG and 96.3% for PCI. Seven patients (0.25%) had minor hematoma and 49 patients (1.7%) had reduced radial pulse 3-4 hours post procedure. Conclusion. Transradial coronary intervention is safe and practical. It should be favored over femoral artery as an initial access point.
J INVASIVE CARDIOL 2014;26(6):273-275
Key words: transradial approach, coronary angiography, percutaneous coronary intervention, safety, success, Chinese
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The first transradial CAG was described by Campeau et al1 in 1989 and the first transradial PCI was performed by Kiemeneij and Laarman2 in 1993. In the past few years, the radial artery approach has become more popular due to lower complication rates in comparison to femoral approach.3,4 Globally, around 20% of coronary interventions are carried out through the transradial route.5,6 European Society of Cardiology (ESC) 2011 guidelines for non-ST elevation acute coronary syndrome declared that the radial approach should be favored in patients at high risk of bleeding, provided that the cardiologist has adequate expertise with this method. In our center, radial interventions started in the year 2007 and nowadays the radial artery is used as a primary site for both CAG and PCI.
The common femoral artery (CFA) is still preferred as the dominant access site for CAG and PCI in many parts of the world, for example the United States, mainly due to the larger vessel size.7 These days, with the advance of technology, we have better and smaller equipment available for coronary interventions, but we still encounter serious vascular access complications via the CFA approach, such as hematomas, retroperitoneal bleed, arterial pseudoaneurysm, arteriovenous fistulas, dissection, or occlusion.8 These often require blood transfusion, surgical intervention, and prolonged hospitalization.9 The radial artery is easily compressed in comparison to brachial artery and CFA, is distant from major veins and nerves, and is not an end artery. Thus, even in case of radial artery occlusion (RAO), the blood supply of the hand will not be compromised.10 The transradial approach offers other advantages, such as fewer vascular access complications, early ambulation, shorter hospital stay, less patient discomfort, and reduced cost.
Compared to many races,11-14 the radial artery in Chinese people is relatively smaller. This could be more troublesome. Our aim was to determine the success rate and safety of transradial CAG and PCI among a Chinese study population.
Methods
This was a prospective study carried out on 2845 Chinese patients in the interventional center of the first affiliated hospital of Nanjing Medical University in Nanjing from August 2012 to July 2013. Patients involved were of all ages and both sexes, and all signed written informed consent before starting the procedure.
Indications for CAG and PCI were acute myocardial infarction, acute coronary syndrome, and abnormal stress test or computed tomography (CT) angiography. Following routine history taking and clinical examination, Allen’s test was performed on each patient’s right hand to evaluate proper dual arterial supply from radial and ulnar artery. Any abnormality in the test would exclude the patient from the study. An experienced interventional cardiologist performed or guided all procedures. The latter was in charge and made all decisions during the entire procedure. Immediately after radial artery catheterization, 2000 units of heparin and 100-200 µg nitroglycerin were administered through the sheath before beginning the procedure. Verapamil (2.5-5 mg) was used only in suspected cases of radial artery spasm. Proper visualization of both coronary arteries was necessary to be accepted as successful CAG. Transradial PCI was considered successful if the entire procedure was carried out via the radial artery. In case of failure to achieve this goal, the surgery was shifted to CFA access. Each patient had their radial pulse examined manually before leaving the catheter laboratory. Radial artery compression device (Terumo band) was utilized in all patients. The device was inflated with 13-15 mL of air and was removed 3-4 hours post procedure, after which radial pulse was examined again.
Complications taken under consideration were vascular access bleeding requiring blood transfusion or vascular repair, large hematoma with hemoglobin drop of 2 mg/dL, arteriovenous fistula, and forearm ischemia requiring intervention.
Age (years) was presented as mean, whereas variables such as gender, success and complications rate, hypertension, diabetes, previous CABG, and bleeding diathesis were shown as number and percentage.
Results
Baseline clinical and procedural data. Baseline clinical characteristics are summarized in Table 1. A total of 1416 CAGs (49.8%) and 1429 PCIs (50.2%) were performed through the right transradial route as a primary site, using 6 Fr sheath catheters in all cases. Our study population comprised 1628 males (57.2%) and 1217 females (42.8%), with a mean age of 64 ± 7.5 years. The population included 1537 patients with hypertension (54.0%) and 501 patients with diabetes (17.6%). Six patients (0.002%) had previous coronary artery bypass graft (CABG) surgery. None of our patients had any bleeding disorder.
Procedural success and complications rate are summarized in Table 2. The overall procedural success rate was 1382 patients (97.6%) for CAG. The reasons for failure (n = 34 cases) included failed radial artery puncture (n = 3), radial artery loop or tortuosity (n = 10), severe radial artery spasm (n = 18), and tortuous subclavian artery (n = 3). A total of 595 patients (42%) who underwent transradial CAG were discharged the same day.
Among the 1429 patients (50.2%) who underwent PCI, 1376 cases (96.3%) were successful. The reasons for failure (n = 53) were radial artery spasm (n = 22), tortuous subclavian artery (n = 6), difficult engagement of guidewire/inability to cannulate the artery (n = 21), and poor guide support (n = 4). Standard anticoagulation and 6 Fr catheter were used in all cases.
We did not come across any major complications in our study. Seven patients (0.25%) suffered from minor forearm hematoma, which was treated conservatively, and 49 patients (1.7%) had reduced radial pulse 3-4 hours post procedure after removal of radial artery compression device. None of our patients required blood transfusion or any surgical intervention for any complications. We did not confirm any radial artery occlusion before hospital discharge since all patients were asymptomatic.
Discussion
In our study, the radial approach in a Chinese population was safe and successful in the majority of the patients. In general, the Chinese physique is smaller compared to many other races. In one study,15 the average Chinese adult body mass index was 22.03 kg/m2 for men and 22.69 kg/m2 for women. The mean right radial artery diameter in Chinese,11,16 measured by ultrasound in two separate studies, was 2.37 ± 0.57 mm and 2.38 ± 0.56 mm.
Bernat et al17 showed the radial route was safe and practical in more than 50% of patients with ST-elevation myocardial infarction and cardiogenic shock managed by primary PCI and was associated with better survival. On the other hand, prognosis was still poor for patients with cardiogenic shock undergoing primary PCI.18 Another prospective study performed on 2209 patients in Amsterdam showed that the use of radial artery in PCI resulted in low access-site crossover and high success rates.
In a retrospective cohort study performed on 4534 patients in Scotland, Johnman et al19 demonstrated a high success rate for radial artery catheterization and minimal vascular complications, as well as better survival within 30 days.
For transradial catheterization in most southern Chinese populations, the use of a 6 Fr sheath and guiding catheter was safe, and the use of 7 Fr sheaths and guiding catheters was possible in some patients. Tortuous and anomalous radial arteries are frequently encountered in southern Chinese people and are responsible for a large percentage of failures in transradial coronary interventions.20
The use of radial access in patients with acute myocardial infarction was questioned, since it could lead to a delay in reperfusion time, especially in the elderly. However, recently it was shown that radial approach does not lead to a lengthening of the door-to-balloon time, suggesting the efficacy of this approach in STEMI patients at presentation.21,22
A meta-analysis for evaluation of outcomes of transradial vs transfemoral access for primary PCI in patients with STEMI carried out by Mamas et al 23 that included 2977 patients demonstrated a marked decrease in major adverse cardiac events and mortality in favor of radial access. The conclusion of the meta-analysis was that the radial approach was preferable to the transfemoral route for primary PCI.24 In the MORTAL (Mortality benefit Of Reduced Transfusion after percutaneous coronary intervention via the Arm or Leg) study, transradial access was associated with half of the transfusion rate and a diminution in 30-day and 1-year mortality.25 The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study also demonstrated that radial access was associated with lower morbidity and cardiac mortality when compared to the CFA approach.
Choussat et al26 compared outcomes in radial and femoral approaches in 150 patients treated with abciximab. Access-site bleeding complications were non-existent in the radial group, vs 5 (7.4%) in the femoral group.27 Transradial PCI success relies upon the skills of the physician. An interventional cardiologist needs to execute ≥50 cases to obtain similar outcomes comparable to experienced operators. The chief limitation of the radial approach is the smaller size of the artery compared to CFA, which increases the risk of spasm, hence requiring small caliber catheters. Cardiologists who employ the radial approach must also be skilled with the femoral approach since it may be needed in cases of radial approach failure or when large guiding catheters are required.
Radial artery occlusion is a serious complication with transradial catheterization; nevertheless, it is rarely clinically important in the presence of adequate ulnar supply to the palmar arch. A total of 1.7% of our patients had reduced radial pulse 3-4 hours post procedure after removal of radial artery compression device. This could have been caused by radial artery trauma. We did not check for vessel occlusion before discharge because all patients were asymptomatic, but this does not rule out radial artery occlusion.
Radial artery ultrasound was done in a study involving 355 patients who underwent transradial coronary procedures.28 The incidence of radial artery occlusion before the procedure, 1 day post procedure, and 1 month post procedure was 0%, 2.8%, and 1.7%, respectively. The authors concluded that transradial coronary procedures can lead to early radial artery injury, but this later healed in the majority of cases.29
Procedural precautions have been shown to somewhat decrease radial artery occlusion. Shorter duration of hemostatic compression is associated with a lower rate of radial artery occlusion, without increase in bleeding complications.30 Patent hemostasis is remarkably efficient in reducing radial artery occlusion after radial access. Guided compression should be done to maintain artery patency at the time of hemostasis.
In our study, we excluded patients with cardiogenic shock.31 This condition is not that rare in patients presenting with acute STEMI, with an occurrence of around 7.5%. In our next study, we will discuss the outcomes of transradial approach in patients with cardiogenic shock undergoing CAG and PCI.
Conclusion
The radial artery approach for CAG and PCI was found to be safe with high degree of success in Chinese population. In experienced hands, it can be a suitable alternative to CFA as a primary site.
Acknowledgment. We extend special thanks to the entire staff of the Nanjing Medical University First Affiliated Hospital catheterization laboratory and to Abdool Aleem Khan for help in the completion of this manuscript.
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From the Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
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 submitted July 29, 2013, provisional acceptance given September 27, 2013, final version accepted November 11, 2013.
Address for correspondence: Prof. Xinli Li, MD, PhD, Cardiology Department, The First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Nanjing, China, 210029; Email: xinli3267@yeah.net