Transradial access compared with femoral puncture closure devices in percutaneous coronary procedures

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1 International Journal of Cardiology 137 (2009) Transradial access compared with femoral puncture closure devices in percutaneous coronary procedures Alessandro Sciahbasi a,, Dionigi Fischetti b, Amedeo Picciolo b, Roberto Patrizi a, Isabella Sperduti c, Giuseppe Colonna b, Francesco Summaria a, Antonio Montinaro b, Ernesto Lioy a a U.O. Cardiologia, Policlinico Casilino, ASL RMB, Rome, Italy b Divisione di Emodinamica, Ospedale Vito Fazzi, Lecce, Italy c Biostatistics Unit, Regina Elena Institute for Cancer Research, Rome, Italy Received 29 January 2008; received in revised form 2 May 2008; accepted 1 June 2008 Available online 8 August 2008 Abstract Background: Transradial access (RA) is associated with less complications and is preferred by patients. Vascular closure devices (VCDs) may improve discomfort and may reduce complications associated with transfemoral access. Aim was to evaluate complications and discomfort associated with percutaneous coronary procedures employing RA or VCDs. Methods: We enrolled 1492 consecutive patients who underwent percutaneous coronary procedures with RA (604 procedures), femoral approach with manual compression (MC) (276 procedures), or with either Angioseal (311 procedures) or Starclose (301 procedures) closure device. Discomfort was assessed using procedure-specific questions. Major vascular complications were evaluated during hospitalization. Results: RA significantly reduced major complications (0.7%) compared to either the MC (2.9%, p = 0.03) or the VCDs (Starclose 2.7%, Angioseal 3.9%, p = 0.003). There were no significant differences in major complications between MC and either the Angioseal or the Starclose. At multivariate analysis the RA was predictor of reduced complications (OR 0.26, 95% CI , p = 0.03 vs MC, and OR 0.19, 95% CI , p = vs VCDs). The RA was associated with a significant reduction in procedural discomfort with 44.2% of patients referring no discomfort (p b ). Starclose and Angioseal were better tolerated than MC (27.8%, 29.3% and 8.9% patients respectively without discomfort, p b ). Conclusions: RA is associated with a significant reduction in major vascular complications compared to femoral approach even if two different VCDs are employed. VCDs are better tolerated than MC but the RA was associated with the lowest discomfort Elsevier Ireland Ltd. All rights reserved. Keywords: Radial; Vascular closure device; Angioseal; Starclose 1. Introduction Corresponding author. UOC Cardiologia, Policlinico Casilino-ASL RMB, Rome, Italy. Tel.: ; fax: address: alessandro.sciahbasi@fastwebnet.it (A. Sciahbasi). Transradial approach (RA) of cardiac catheterization is a common alternative to transfemoral access for diagnostic coronary angiography and percutaneous coronary interventions (PCI) [1]. The RA reduces access bleeding complications [2] and reduces the procedural discomfort of the patients [3] mostly due to the prolonged vascular compression time and bed rest length associated with the transfemoral access. However, RA is more demanding for the operator with longer learning curve [4], increased fluoroscopy time [5,6] and reduced possibility to perform coronary interventions with 7 or 8 French catheters [7]. Vascular closure devices (VCDs) have been developed to reduce bed rest and vascular complications after PCI performed through femoral access [8]. When compared to /$ - see front matter 2008 Elsevier Ireland Ltd. All rights reserved. doi: /j.ijcard

2 200 A. Sciahbasi et al. / International Journal of Cardiology 137 (2009) manual compression these devices facilitate patient mobilization, decrease length of hospital stay and improve patient satisfaction level [9,10]. However the role of VCDs compared to RA in terms of patient discomfort is still undetermined. The Angioseal is an extensively used VCD, with over 5 million devices used up to now, that provide rapid and easy vascular closure following diagnostic and interventional procedures. The device is composed of a collagen sponge and a specially designed adsorbable polymer which ensure an endovascular arteriotomy closure. A large meta-analysis [11] showed a reduced trend toward less complications with Angioseal compared to manual compression. The Starclose is a newer VCD that provides extravascular hemostasis by a star-shaped nitinol clip. A recent study [12] did not demonstrate significant differences in major complications compared to the Angioseal VCD. However there are no studies comparing the risk of complications with these two VCDs and the risk associated with the transradial access. Aim of this dual center observational study, Transradial Access compared with femoral puncture closure devices in percutaneous coronary procedures (TARANTA study), was to compare the procedural risk of vascular complications associated with the RA compared with the use of two different VCDs for femoral closure and to evaluate the patient discomfort associated with the use of VCDs or the RA. 2. Methods 2.1. Patient population From January 2006 to March 2007, we prospectively enrolled consecutive patients referred for cardiac catheterization or percutaneous coronary intervention in two different hospitals (Policlinico Casilino, Rome, Italy and Vito Fazzi Hospital, Lecce, Italy). Of the 2744 patients who underwent percutaneous coronary procedures, 1492 were included in the study: patients were excluded for known vascular disease precluding arterial access, ischemic Allen test, ST-segment elevation acute myocardial infarction, need to use arterial sheaths other than 6 French in diameter, angiographic contraindication to vascular closure device, history of bleeding diathesis, emergency catheterization, lack of informed consent, patients unable to answer our quality of life questionnaire (patients intubated, dementia) or patients referred from department other than cardiology. Procedures were performed by 8 different interventional cardiologists and patients underwent coronary procedures in accordance with the routine practice of the single operator. Three operators performed systematic radial approach, two operators systematic femoral approach followed by manual compression, three operators systematic femoral approach with either Angioseal VIP (St. Jude Medical, St. Paul, Minnesota, US) closure device or Starclose (Abbott Vascular, Redwood City, California, US) closure device. Each operator performed at least 300 procedure per year. The study has been approved by Institutional Ethical Committee and written informed consent was obtained to take part of the study Procedure A 6 French artery sheath was utilised in all cases. Only in the RA group, the Allen test was performed prior to the procedure and patients with ischemic results (7% of screened patients) were excluded from the study. The radial artery approach was performed using an hydrophilic guidewire and hydrophilic sheath (Radifocus, Introducer II, Terumo Corporation, Tokyo, Japan). After sheath insertion, 2.5 mg of verapamil were injected directly into the radial artery and 5000 units of unfractioned heparin were administrated intravenous to all patients. Additional units of unfractioned heparin were given prior to the interventional procedure under activated clotting time guidance ( s or s if glycoprotein IIb/IIIa inhibitors were used). In the femoral approach a 6 French non-hydrophilic sheath was utilised and unfractioned heparin was given only prior to an interventional procedure according to the activated clotting time results ( s or s if glycoprotein IIb/IIIa inhibitors were used). The activated clotting time was monitored after the procedure only in the manual compression group. Most patients underwent coronary angiography followed by coronary intervention in the same procedure: if the coronary intervention needed the use of catheters bigger than 6 French, the patient was excluded from the study Sheath management In the radial group, the radial artery sheath was immediately removed at the end of the procedure (either diagnostic or interventional) and hemostasis was obtained using an inflatable wrist band (TR-BAND, Terumo Corporation, Tokyo, Japan). The compression device was progressively deflated and completely removed within 6 8 h. Patients were allowed to ambulate within 1 h after the procedure unless contraindicated by their clinical conditions. In the manual compression group, the femoral sheath was removed immediately after the procedure (in case of diagnostic exam) or when the activated clotting time was less than 180 s (in case of interventional procedure). Hemostasis was obtained by manual compression, lasting at least 20 min, and subsequent femoral bandage. These patients had to rest in bed overnight and were allowed to walk the following morning unless their clinical status did not advise early mobilization. In the Angioseal VIP and Starclose group the arterial closure was performed in the cardiac catheterization laboratory at the end of the procedure. Patients were allowed to ambulate within 3 h unless contraindicated by clinical status.

3 A. Sciahbasi et al. / International Journal of Cardiology 137 (2009) Table 1 Clinical and procedural characteristics of patients. Manual compression (n=276) Starclose (n=301) Angioseal VIP (n=311) Transradial approach (n=604) p Clinical Age (years) 67.53± ± ± ± Males (%) Weight (kg) 73.53± ± ± ± Height (cm) ± ± ± ± Body mass index (kg/m 2 ) 26.77± ± ± ± ACS (%) Diabetes (%) Procedural PCI (%) Multivessel PCI (% of PCI) Thienopyridines (%) b GP IIb/IIIa inhibitors (%) b a Fluoroscopy time (min) 6 (1 61) 6 (1 45) 5 (1 58) 8 (1 62) b Results are expressed as mean and standard deviation. Discrete variables are expressed as percent. ACS: acute coronary syndromes; GP: glycoprotein; PCI: percutaneous coronary interventions. a Median and range Vascular closure devices The Starclose vascular closure system is composed of an introducer sheath, dilator, guide wire and a clip applier, with a nitinol clip housed in the clip applier. When released from the clip applier, tines on the clip grasp the edges of the vascular tissue and draw them together to close the arteriotomy site. The system is designed to provide mechanical closure without impinging the vessel lumen. The Angioseal VIP vascular closure device is composed of a collagen sponge and a specially designed adsorbable polymer anchor that are connected by an adsorbable suture. The device seals the arteriotomy between the anchor and the collagen sponge. The hemostasis is enhanced by the coagulation-inducing properties of the collagen. Femoral angiography was performed with 10 ml of contrast in right anterior 30 projection in all subjects before deploying both vascular closure devices. The following angiographic criteria were used to guide VCD deployment: 1. a femoral puncture far more than 4 5 mm from the femoral bifurcation; 2. femoral vessel greater than 4 mm and 3. absence of diffuse calcification or vascular stenosis greater than 40%. If the femoral artery was not suitable to VCD closure, the patient was excluded from the study and the hemostasis was obtained by manual compression. without ischemia of the arm, failure of the vascular closure device. VCD failure was considered the inability to use the device or the persistence of bleeding after the deployment requiring manual compression. Procedural failure was considered the inability to cannulate the coronary ostia or the inadequate catheter support or the inability to track a device in place Quality of life assessment Quality of life was assessed in all patients the day after the procedure using a series of procedure-specific questions as previously documented [3]. The procedure-specific questions 2.5. Definition of complications Major complications include vascular death, pseudoaneurysm, arteriovenous fistula, major bleeding requiring blood transfusion or surgical intervention, surgical intervention at the puncture site, ischemic complication of the limb, stroke or transient ischemic attack. Minor complications include haematoma not requiring blood transfusion or vascular repair, loss of radial pulse Fig. 1. Differences in major vascular complications between groups. The radial approach was associated with a significant reduction in major vascular complications compared with both the manual compression and the vascular closure devices groups. There were no significant differences between manual compression and vascular closure devices or between Starclose and Angioseal VIP. MC: manual compression; RA: transradial approach.

4 202 A. Sciahbasi et al. / International Journal of Cardiology 137 (2009) Table 2 Details of vascular complications. MC (n=276) Starclose (n=301) Angioseal VIP (n=311) RA (n=604) Major complications n (%) 8 (2.9) 8 (2.7) 12 (3.9) 4 (0.7) Vascular death 0 (0) 0 (0) 0 (0) 0 (0) Bleeding requiring transfusion or vascular surgery 5 (1.8) 5 (1.7) 3 (1) 1 (0.2) Pseudoaneurysm requiring surgery 1 (0.4) 1 (0.3) 4 (1.3) 0 (0) Other surgical interventions at the puncture site 0 (0) 2 (0.7) 0 (0) 0 (0) Ischemic complications of the limb 1 (0.4) 0 (0) 4 (1.3) 0 (0) TIA 1 (0.4) 0 (0) 1 (0.3) 2 (0.3) Stroke 0 (0) 0 (0) 0 (0) 1 (0.2) Failure of the VCD n (%) 9 (3) 4 (1.3) Access site failure n(%) 0 (0) 0 (0) 0 (0) 15 (2.5) Procedural failure n (%) 2 (0.7) 1 (0.3) 1 (0.3) 9 (1.5) Loss of radial pulse n (%) 7 (1%) MC: Manual compression; RA: transradial approach; TIA: transient ischemic attack; VCD: vascular closure device. used 0 to 10 visual analog scales [13] to assess overall discomfort, the ability to eat, the difficult to urinate, the discomfort of the bed rest and the discomfort related to the vascular compression. The questionnaires were filled by the patients after standardized instructions given by nurses. We considered low discomfort scores ranging from 0 to 5 and high discomfort scores ranging from 6 to Statistical analysis Data are presented as mean and standard deviation unless otherwise noted. Student's t-test and Analysis of Variance (ANOVA) were used to compare mean values with the Bonferroni correction employed to adjust for multiple comparisons. A 2-tailed p value of 0.05 was considered statistically significant. The normality assumptions for ANOVA were assessed with the Kolmogorov Smirnov test. Comparisons of proportions between groups were performed using a two-sided chi-square test, or if the number expected of patients was less than five, a two-sided Fisher's exact test, both adjusted for multiple comparisons. Multivariate logistic regression analysis was performed to identify independent clinical and procedural predictors of major vascular complications in all patients. The cut-off p value to be enrolled or excluded from the model were set to 0.10 and Results are expressed as odds ratio (OR) with 95% Confidence Interval (CI). The SPSS (version 11.0) was used for all analysis. 3. Results Clinical and procedural characteristics of all patients undergoing coronary procedures (diagnostic or interventional) are shown in Table 1. During the 15 months of the study, 604 patients underwent coronary angiography or PCI through RA (274 PCI), 276 patients through femoral access followed by manual compression (122 PCI), 301 patients through femoral access closed with Starclose VCD (152 PCI) and 311 patients through femoral access closed with Angioseal VIP VCD (110 PCI). All groups were well matched for age, sex, weight, height, body mass index and history of diabetes. More than 30% of the patients in each group were referred for an acute coronary syndrome without significant differences between groups. The number of PCI was significantly lower in the Angioseal VIP group and the use of glycoprotein IIb/IIIa inhibitors and thienopyridines Table 3 Univariate and multivariate analysis for major complications. Univariate analysis Multivariate analysis OR (95% CI) Age (b75 vs 75) 0.50 ( ) Sex (M vs F) 0.48 ( ) BMI 0.95 ( ) Fluoroscopy time 1.02 ( ) Access site (Manual Compression 0.88 vs VCDs) ( ) (RA vs VCD) 0.20 ( ) (RA vs Manual 0.22 compression) ( ) ACS (yes vs no) 0.84 ( ) GPIIb IIIa inhibitors 0.66 (yes vs no) ( ) Diabetes (yes vs no) 2.37 ( ) Thienopyridines 0.85 (no vs yes) ( ) Procedure (Coronarography 0.79 vs PCI) ( ) p value OR (95% CI) p value ( ) 0.04 NS ( ) ( ) ( ) ( ) ACS: acute coronary syndromes; BMI: body mass index; CI: Confidence interval; GP: glycoprotein; NS: not significant; PCI: percutaneous coronary interventions; OR: odds ratio; RA: transradial approach; VCD: vascular closure device. OR and CI can only be calculated for two variables.

5 A. Sciahbasi et al. / International Journal of Cardiology 137 (2009) Fig. 2. Odds ratio for major complications. The reduction in major complications associated with the radial approach was observed in all subgroups analysed. ACS: acute coronary syndromes; GP: glycoprotein; MC: manual compression; PCI: percutaneous coronary interventions; RA: transradial approach; VCD: vascular closure device. was significantly higher in the manual compression and RA groups compared to VCD groups (pb0.0001). The RA was associated with a small but significant increase in fluoroscopy time compared to manual compression and VCD groups (pb0.0001) Complications Major complications were significantly lower in the RA group (0.7%) compared both to the manual compression group (2.9%, p=0.03) and to the VCD groups (2.7% for Starclose, 3.9% for Angioseal VIP, p = 0.003). There were no significant differences between manual compression and either the Angioseal VIP or the Starclose groups in major complications (Fig. 1). The reduction in major complications observed in the RA group was mainly driven by less bleeding complications (Table 2). At the univariate analysis age b75 years, male sex, the absence of diabetes and the RA were associated with a significant reduction in the rate of complications. However, the multivariate logistic regression analysis identified the RA as predictor of reduced rate of complications (OR 0.19, 95% CI vs VCDs, p=0.003 and OR 0.26, 95% CI vs manual compression, p = 0.03) and identified the diabetes as predictor of increase rate of complications (OR 2.11, 95% CI , p=0.04), (Table 3). Moreover the reduction in major complications associated with the RA was observed in all subgroups considered (Fig. 2). Table 4 Quality of life associated with the procedure. Manual compression (n=276) Starclose (n=301) Angioseal VIP (n=311) Transradial approach (n=604) p Any discomfort Difficult to urinate (%) b Difficult to eat (%) b Pain for compression (%) b Discomfort of bed rest (%) b Global discomfort (%) b High (6 10 points) discomfort Difficult to urinate (%) b Difficult to eat (%) b Pain for compression (%) b Discomfort of bed rest (%) b Global discomfort (%) b0.0001

6 204 A. Sciahbasi et al. / International Journal of Cardiology 137 (2009) The rate of failure of the two different VCDs was similar accounting for 1.3% in the Angioseal VIP group and 3% in the Starclose group (p=0.143, Table 2). The procedural failure was very low in all groups but higher in the RA group compared with the other groups (Table 2). In 15 patients (2,5%) of the radial group the radial artery could not be successfully inserted. The following day after the procedure the radial artery was not palpable in 7/604 patients (1%) of the RA; all these patients were asymptomatic without further clinical vascular events Procedural discomfort The RA was associated with a significant reduction in all parameters of procedural discomfort compared to the other groups (Table 4) with 44.2% of patients referring no discomfort for the procedure (pb0.0001). VCDs were better tolerated than manual compression in terms of shorter length of bed rest and of less global discomfort (Table 4). When data were analysed considering low (0 5 points) and high (6 10 points) discomfort scores, all the procedures (RA, VCDs and manual compression) were well tolerated with less than 10% of patients showing high global discomfort (Table 4). However both the RA and the use of VCDs were better tolerated than the manual compression for all the parameters considered. 4. Discussion This study compared the transradial approach for coronary procedures with two different and extensively used vascular closure devices. The main finding of the study is that RA is associated with less major complications compared to VCDs and with better patient comfort. The benefit of transradial access for coronary intervention has been well documented in the literature [14]: access site bleeding complications are rare and length of hospital stay is significantly reduced compared to the traditional femoral access. However, RA is considered more demanding for the interventional cardiologist and the use of VCDs for femoral procedures represents a good alternative in order to reduce vascular complications [15] and patient discomfort [9,10].In addition the recently published European Guidelines for non-st elevation myocardial infarction endorse the use of closure devices as well as the radial approach to reduce bleeding complications in patients undergoing percutaneous coronary interventions [16]. In our study similar major complications were observed in the VCD and manual compression groups, whereas the RA had the lowest incidence of vascular complications. This reduction in vascular complications is attractive because it was associated with a reduction in bleeding complications, a known risk factor for worse prognosis in patients with acute coronary syndromes [17,18]. Moreover in our study the lower rate of vascular complications in the RA group was observed despite a significantly higher use of glycoprotein IIb/IIIa inhibitors and thienopyridines compared to VCD groups and even if vascular cerebral accidents were included among major vascular complications. Cerebral accidents were considered as major vascular complication on the basis of significantly RA related increased incidence of cerebral accidents and cognitive disorders reported in some studies [19]. A significant reduction in access site complications with RA compared to the use of the Perclose VCD has been previously reported [5]. However in that study an early generation of vascular closure device with known higher complication rates compared to the Angioseal [9], was used. Moreover high rates of patients exclusion and crossover to standard manual compression interfered with the interpretation of the results. Newer devices like the Angioseal VIP and the Starclose systems are associated with higher closure success rates and with reduced incidence of vascular complications, and have not yet compared to RA. Many studies have reported that patient satisfaction was higher using VCDs in comparison to manual compression [9,10]. In fact the use of VCDs was significantly better tolerated by the patients due to reduction in bed rest length, in discomfort to urinate and to eat and with the compression related pain. However to our knowledge previous studies comparing the tolerability of VCDs to RA have not been performed. In our study we confirmed that VCDs are better tolerated than manual compression; on the other hand when VCDs are compared to RA, the latter is better tolerated particularly because of a reduction in the discomfort related to bed rest. RA is not extensively employed by interventional cardiologists because there are some concerns about the higher than with femoral approach procedural failures and about the risk of post-procedural occlusion of the radial artery. In our study the procedural success with RA was high (96%) and similar to previous studies [7]. Moreover, in our opinion, the use of an inflatable wrist band for radial hemostasis, that ensures a progressive artery decompression, was related to a low rate of post-procedural pulse loss. This incidence in our study was very low (1%) and lower than reported in other studies [19,20], although 6F sheaths and 6F catheters were used in all procedures. However, in our study, RA was associated with a slight but significant increase in fluoroscopy time as previously documented [5,6,21]. High volume catheterization labs have to consider special precautions in order to improve the X-ray protection during coronary procedures via the RA. In other studies [22,23] RA has also been employed to perform primary percutaneous interventions in the setting of acute ST-elevation myocardial infarction with comparable results to the femoral approach. However in our study we excluded patients with ST-elevation myocardial infarction for two reasons: a. to avoid confounding results evaluating the periprocedural quality of life assessment and b. to avoid a selection bias in a non-randomised trial because in such high

7 A. Sciahbasi et al. / International Journal of Cardiology 137 (2009) risk procedures the RA might not be the preferred technique for all patients. The choice of the access site was not determined in a randomized way and this may limit the results of our study. However in the comparison of different vascular accesses performed by operators who routinely employ a particular technique (RA or VCDs), we excluded the complications that may be observed during operator learning curves, or related to a reduced skill both with RA and the use of VCDs. Other limitations of our study consist in the short in hospital follow-up and in the diagnosis of vascular complications based on clinical data rather than guided by image studies. In conclusion our study shows a reduction in major vascular complications with transradial approach compared to femoral approach, even if two different vascular closure devices are employed. The transradial approach is also associated with better patient tolerability. Vascular closure devices seem to be a good option alternative to manual compression in terms of better patient comfort, although the complications rates are similar. Acknowledgement The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology [24]. References [1] Archbold RA, Robinson NM, Schilling RJ. Radial artery access for coronary angiography and percutaneous coronary intervention. BMJ 2004;329: [2] Agostoni P, Biondi-Zoccai GGL, De Benedictis ML, et al. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures. J Am Coll Cardiol 2004;44: [3] Cooper CJ, El-Shiekh RA, Cohen DJ, et al. Effect of transradial access on quality of life and cost of cardiac catheterization: a randomised comparison. Am Heart J 1999;138: [4] Goldberg SL, Renslo R, Sinow R, French WJ. 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