Background. Arterial access site management after percutaneous coronary intervention (PCI) is a matter of increasing importance in this era of potent antiplatelet pharmacotherapy. We evaluated the safety and efficacy of a 6 French (Fr) Perclose suturing device in achieving rapid hemostasis of the access site after PCI and thus improving patient comfort. Methods. The 6 Fr Perclose (Prostar) device consists of a suture-based closure device delivered via introducer sheath designed for suturing of the arteriotomy puncture site. Over a 3-month period, the device was used in 48 consecutive PCI treated patients (age, 62 ± 13 years; 70% male; 44% post myocardial infarction) and in-hospital groin complication rate was compared to 48 consecutive patients (age, 64 ± 12 years; 64% male; 33% post myocardial infarction) who had manual compression hemostasis. Results. Antiplatelet glycoprotein IIb/IIIa antagonists were used more frequently during and following the procedure in 58% of Perclose-treated patients versus 42% of the manual compression group (p = 0.019). Leg immobilization duration was 3–4 hours in all patients sutured by the device; in patients with manual compression, the sheath was removed at an average of 4.8 ± 2.5 hours after termination of the PCI and an additional 6 hours of leg immobilization were subsequently required. No difference in overall major complication rate was found between groups (6.2% in suture-mediated patients versus 9.3% in manual compression group; p = 0.60). In 3 patients (6.2%) treated using the device, adjunctive manual compression was required in addition to groin suturing due to technical failure or residual oozing from the arteriotomy site. Conclusion. The 6 Fr Perclose device can be safely used to achieve rapid hemostasis and the device may hasten bed mobilization of PCI-treated patients despite frequent use of potent antiplatelet pharmacotherapy during coronary interventions.

       Arterial access site management after percutaneous coronary intervention (PCI) is a matter of increasing importance in this era of more complex procedures with frequent use of potent antiplatelet pharmacotherapy.1 The morbidity associated with post-catheterization groin complications, such as bleeding, large hematoma, pseudoaneurysm and other complications, is not frequently life threatening; however, it is often associated with profound discomfort, prolonged hospital stay, need for vascular repair, blood transfusion and increased cost.2 The Prostar suture-mediated closure device (Perclose™, Abbott Laboratory, Redwood City, California) was recently approved for clinical use in Israel. Prior to its widespread used among operators at our institution, we sought to evaluate the safety and efficacy of the 6 French (Fr) version of this device in achieving rapid hemostasis of the access site after PCI and thus improving in-bed mobilization and overall patient comfort.

Methods

       The 6 Fr Prostar device consists of a suture-based closure device delivered through a 0.035´´ guidewire using an introducer sheath specifically designed for subcutaneous suturing of the arteriotomy puncture site (Figures 1A–1D).3 The prototype device used an 8 Fr closure sheath (Prostar-Plus) and thus caused a mismatch in sheath size when using a 6 Fr diagnostic or interventional procedure catheter. Recently, the 6 Fr Prostar suture-mediated closure device version was designed for 5 or 6 Fr catheter-based procedures. Over a 3-month period, the device was used in 48 consecutive PCI-treated patients at our institution and in-hospital groin complication rate was compared to another group of 48 consecutive patients who underwent manual compression hemostasis. We undertook a detailed surveillance of groin complications. Manual compression was performed in the cardiology department 4 hours after termination of the angioplasty procedure without intravenous glycoprotein (GP) IIb/IIIa antiplatelet administration, and after 6 hours in cases of systemic antiplatelet administration. Patients were then instructed to withhold leg immobilization for an additional 6 hours; thus, total leg immobilization time was 10–12 hours for the “manual compression” session. Unless instructed otherwise, leg immobilization was 3–4 hours in patients treated using the Perclose device followed by in-bed leg mobilization. In both groups, all patients became fully mobilized by the morning after the interventional procedure. Patients were excluded from the study if they had the following: 1) multiple (> 1) groin sticks; 2) history of peripheral vascular disease or reduced femoral pulse; 3) prior (within one month) coronary or peripheral groin-mediated angiographic procedure; or 4) any difficulty in obtaining “smooth” insertion of the femoral sheath.

Figure 1

(A) Insertion and positioning of the 6 French Perclose device into the femoral access site with pulsatile flow through the marker lumen indicating an adequate intraluminal device position. (B) Deployment of foot and positioning against the arterial wall in preparation for suturing followed by needle deployment. (C) Suture retrieval across the arterial wall using the pull-through needles. (D) A closer look at the suture created after pulling back the device followed by a final Clincher Knot tying (not shown).

       Patient demographics and procedure-related variables were collected for all subjects. All patients underwent either 5 or 6 Fr diagnostic procedures, followed by an interventional procedure using a 6 Fr guiding catheter. Successful vascular device closure was defined as complete arterial hemostasis without need for additional manual compression or surgical repair. Large hematoma was defined as hematoma >= 10 cm in superficial diameter or any hematoma responsible for at least one unit of blood transfusion. Pseudoaneurysm was defined as a communication between an extra-luminal cavity and the femoral artery with a back-and-forth flow pattern demonstrated by color Doppler. Retroperitoneal bleeding was defined as an accumulation of blood in the abdominal cavity as demonstrated by computerized tomography (CT) scan. Infection was defined as erythema and pain around the arterial puncture site associated with fever and leukocytosis. The need for vascular surgery was recorded. In this analysis, small hematoma and/or local superficial infections that did not mandate the administration of systemic antibiotics were considered to be “clinically insignificant” vascular complications. Large hematoma, pseudoaneurysm, retroperitoneal bleed, blood transfusion and surgical repair were classified as “major groin complications”.
       All continuous variables were listed within their standard deviations. The t-test was used to determine significant differences for continuous variables and the Chi-square test was used to calculate differences in categorical values between groups (suture versus manual compression). Probability value < 0.05 was considered statistical significant.

Results

       Patient demographics were similar between groups (Table 1). All patients except for one in each group underwent a successful coronary stenting procedure and had oral clopidogrel administration for 4 weeks. Two patients (one in each group) underwent coronary balloon angioplasty without stent implantation. Antiplatelet GP IIb/IIIa antagonists were used more frequently during and following the procedure in 58% of suture-mediated groin closure patients versus 42% of the manual compression group (p = 0.019). The use of antiplatelet pharmacotherapy was initiated immediately prior to PCI in the catheterization laboratory in all patients. Final activated clotting time values were comparable between groups (247 ± 68 seconds versus 262 ± 87 seconds; p = 0.17). Leg immobilization was 3–4 hours (mean, 3.8 ± 0.2 hours) in all patients treated using the device. In patients with manual compression, the sheath was removed an average of 4.8 ± 2.5 hours after termination of the PCI. Six additional hours of leg immobilization were subsequently required to prevent bleeding. Details and periprocedural groin complication rate are presented in Table 2. No difference in overall major complication rate was found between groups (6.2% in Prostar-treated patients versus 9.3% in the manual compression group; p = 0.60). In 3 patients (6.2%) treated using the device, adjunctive manual compression was required in addition to groin suturing due to technical failure or residual oozing from the arteriotomy site. In these cases, leg immobilization was prolonged for 6 hours following sheath removal. No patient sustained retroperitoneal bleeding or needed blood transfusion. One patient had pseudoaneurysm and large groin hematoma following manual compression and thus underwent a vascular repair.

Discussion

       Initial use of the 8 Fr prototype version of the Perclose device was reported by Carere et al.3 and included 32 closure-device attempts with most patients receiving anticoagulation. There were 4 failures to achieve hemostasis using the device and 3 additional cases of “suture breaks”, with an overall procedural success of 88%. The Suture To Ambulate And Discharge (STAND I) trial evaluated the 6 Fr suture-mediated device in 200 patients undergoing diagnostic procedures, with successful hemostasis achieved in 99% of patients and 1% major complications.4 STAND II randomized 515 patients undergoing diagnostic or interventional procedures to the 8 or 10 Fr (Prostar-Plus) device versus traditional compression. Successful suture-mediated hemostasis was achieved in 97.6% of patients compared to 98.9% of patients with compression. Major complication rates were 2.4% and 1.1%, respectively (p = NS). Median time to hemostasis (19 minutes versus 243 minutes, respectively; p < 0.01) and time to ambulation (3.9 hours versus 14.8 hours, respectively; p < 0.01) were significantly shorter for suture-mediated closure in this study. Cura et al.5 tested the feasibility of using 8 Fr Perclose devices in conjunction with antiplatelet blockade during PCI. They demonstrated that the closure device had a similar risk profile to manual compression, even in patients treated with systemic platelet inhibition. Kahn et al. reported a large consecutive series of immediate groin suturing using the 8 Fr Prostar-Plus device in a large cohort of diagnostic and interventional cases.6 A significantly higher complication rate was noted in the diagnostic catheterization patients treated with the device compared to diagnostic catheterization patients treated with compression (2.6% major and 4.6% minor complication rate for the device versus 0.2% major and 1.8% minor complication rate for manual compression). However, for the interventional patients, there were no notable differences in either major or minor complications between groups. These results are explained by the use of an 8 Fr suture device which enlarged an initial 5 and 6 Fr arteriotomy site used for diagnostic purposes, in contrast to interventional cases where the 8 Fr device was matched to a larger sheath size. In our series, all patients underwent PCI using 6 Fr guiding catheters. Thus, according to our limited experience, the 6 Fr Prostar device seems to accommodate well the need for earlier ambulation without an excessive arteriotomy site enlargement as was observed in the report by Kahn et al.6
       Dangas et al. evaluated vascular complications after hemostasis with various types of arteriotomy closure devices (including the Prostar 8 Fr device) versus manual compression after PCI in 5,093 patients.7 In their analysis, the more generalized use of various closure devices was associated with more frequent occurrence of hematoma compared to compression (9.3% versus 5.1%, respectively), higher rate of significant hematocrit drop (5.2% versus 2.5%, respectively) and similar rates of pseudoaneurysm and fistula formation. Also, vascular surgical repair at the access site was required more often with the closure device (2.5 versus 1.5% for the manual compression group). It is possible that a more selective use of closure devices (including Perclose) is advisable in order to limit vascular complications when attempting to accelerate post-PCI patient comfort and ambulation. A more favorable experience was reported by Resnic et al., who examined 1,485 PCI-treated patients who received a closure device, with the majority of patients receiving systemic antiplatelet treatment.8 The overall vascular complication rate was 4.2% in this study. By univariate analysis, the use of closure devices was associated with a lower vascular complication rate and a shorter length of hospital stay. Multivariate analysis showed a significant reduction in vascular complications with the closure devices (odds ratio, 0.59). In the subgroup of patients receiving GP IIb/IIIa antagonists, the use of closure devices was associated with a profound reduction in the risk of vascular complications (odds ratio, 0.45).
       Prior to its generalized use among patients undergoing PCI at our institution, we sought to examine the feasibility, safety and efficacy of the 6 Fr Perclose device performed immediately after completion of PCI. Based on our pilot experience, which included a “learning curve” phase for some operators, we conclude that the 6 Fr device (matched for a 6 Fr femoral sheath) can be safely used to achieve rapid hemostasis and potentially hasten bed mobilization (and perhaps also ambulation) among PCI-treated patients. The results presented herein were obtained despite more frequent use of antiplatelet pharmacotherapy during coronary interventions among device-managed patients and despite the achievement of optimal level of anticoagulation during PCI according to clotting time measurements. The overall complication rate was 6.2% using the closure device (versus 9.2% in the manual compression group), but it is important to note that all 3 patients who had groin complications had large hematomas (defined as >= 10 cm in superficial diameter) rather than pseudoaneurysm or retroperitoneal bleeding. Groin hematoma without pseudoaneurysm was considered to be a “softer” endpoint in our study and its prevalence was comparable among the study groups. In 2 of 3 patients, failure to achieve complete hemostasis with the device was probably related to “learning curve” experience in 2 cases and was due to technical failure caused by a single “suture break” in 1 additional case.
       The closure device enabled faster in-bed leg mobilization and is also likely to improve patient comfort prior to full ambulation. As a cautious step in this study, complete mobilization was allowed only the following day after PCI. In theory and in practice, one may consider allowing earlier (i.e., same day) ambulation in cases of rapid and complete suture-mediated hemostasis and no need for continued systemic intravenous administration of antithrombotic treatment. However, it is still our practice to instruct all patients to stay in bed overnight prior to their subsequent hospital discharge. Nonetheless, it should be noted that in our study the device allowed faster mobilization because our protocol was to keep manually compressed patients immobilized for a longer period. Thus, based on our study, we can only state that it is likely that the Perclose device will allow faster mobilization, although the results are not conclusive.
       Finally, the cost of a single Perclose device in Israel is approximately $150. It is beyond the scope of this work to address the issues of “cost-effectiveness” or “cost-saving” parameters and to determine the budget considered “reasonable” to spend in order to improve patient comfort during the relatively short recovery period after PCI. However, a rough estimation for our interventional facility performing approximately 2,000 PCI procedures per year, with an estimated 50% use of suturing devices following PCI (excluding diagnostic procedures), would be $150,000 per year (the additive non-reimbursable cost). This is a significant budget that needs to be carefully taken into consideration and weighed against potential savings parameters. Specifically, these calculations should be weighed against potential cost savings from early ambulation or even facilitating the performance of ambulatory angioplasty procedure in institutions where “same-day” discharge is a common practice in suitable cases.

1. Waksman R, King SB III, Douglas JS, et al. Predictors of groin complications after balloon and new-device coronary intervention. Am J Cardiol 1995;75:886–889.
2. Nasser TK, Mohler ER III, Wilensky RL, Hathaway DR. Peripheral vascular complications following coronary interventional procedures. Clin Cardiol 1995;18:609–614.
3. Carere RG, Webb JG, Ahmed T, Dodek. Initial experience using Prostar: A new device for percutaneous suture-mediated closure of arterial puncture sites. Cathet Cardiovasc Diagn 1996;37:367–372.
4. Baim DS, Knopf WD, Hinohara T, et al. Suture-mediated closure of the femoral access site after cardiac catheterization: Results of the suture to ambulate and discharge (STAND I and STAND II) trials. Am J Cardiol 2000;85:864.
5. Cura FA, Kapadia SR, L’Allier PL, et al. Safety of femoral closure devices after percutaneous coronary interventions in the era of glycoprotein IIb/IIIa platelet blockade. Am J Cardiol 2001;87:504.
6. Kahn ZM, Kumar M, Hollander G, Frankel R. Safety and efficacy of the Perclose suture-mediated closure device after diagnostic and interventional catheterizations in a large consecutive. Cathet Cardiovasc Intervent 2002;55:8–13.
7. Dangas G, Mehran R, Kokolis S, et al. Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices. J Am Coll Cardiol 2001;38:642–644.
8. Resnic FS, Blake GJ, Ohno-Machado L, et al.Vascular closure devices and the risk of vascular complications after percutaneous coronary intervention in patients receiving glycoprotein IIb/IIIa inhibitors. Am J Cardiol 2001;88:493–496.