Safety and Efficacy of a 6 French Perclose Arterial Suturing Device Following Percutaneous Coronary Interventions: A Pilot Evalu

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. 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 = 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.

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