Use of FemoStop‚Ñ¢ System for Arterial Puncture Site Closure After Coronary Angioplasty

ABSTRACT: Different protocols exist concerning the method and timing of post-coronary angioplasty arterial puncture site closure. Easy handling and good effectiveness are well-documented for the Femostop™ femoral artery compression system; however, no hard data exist concerning the relationship between heparin anticoagulation level and femoral artery compression time (FSCT). Thus, we prospectively randomized 267 patients after elective percutaneous transluminal coronary angioplasty (PTCA) into two groups [group A (n = 137) had early sheath removal 6–8 hours after PTCA; group B (n = 130) had late sheath removal 14–16 hours after PTCA] and analyzed the dependence of the FSCT on the heparin anticoagulation level (aPTT) and the incidence of vagal reactions and puncture site complications. FSCT was significantly longer in group A (69 ± 27 minutes versus 45 ± 15 minutes; p 1,3,7,11 At many institutions, the puncture site is manually compressed after coronary angiography until hemostasis begins and a compression bandage is subsequently applied for 12–24 hours. In contrast, larger puncture sites and intense heparinization are used during percutaneous transluminal coronary angioplasty (PTCA), and thus mechanical compression systems such as the FemoStop™ system or specialized closure systems based on collagen plugging or suture technology (e.g., Vasoseal™ or Perclose™) are used.^1,3,15 There are no data in the literature regarding the FemoStop system with respect to femoral artery compression times in relation to coagulation status and sheath removal time after PTCA. We investigated the practical use of this system in a clinical study involving patients undergoing elective PTCA. Methods Patients. Two hundred ninety-six patients with elective PTCA were successively randomized since December 2001 in a prospective study and divided into two groups: 1) group A, with early sheath removal, i.e., 6–8 hours after PTCA; and 2) group B, with late sheath removal, i.e., 14–16 hours after PTCA. The FemoStop compression time (FSCT) until primary hemostasis, the incidence of post-procedural bleeding, inguinal hematomas and false aneurysms in the first 36 hours, and also the occurrence of vagal reactions using the FemoStop system were analyzed in relation to sheath removal time and the heparin anticoagulation status. Patients with peripheral arterial occlusive disease were not included in the study. All study participants gave their consent for the procedure with respect to the technique and time of sheath removal. A total of 267 patients (age, 63 ± 9 years; 187 male, 80 female) were evaluated, all of whom received identical antithrombotic therapy (ASS, 100 mg/day and 2 x 250 mg ticlopidine/day) prior to PTCA and also standardized heparinization during PTCA (5,000 IU intravenous heparin before PTCA and 10,000 IU intracoronary heparin during PTCA). The other 29 patients could not be analyzed due to abnormal laboratory findings [activated partial thromboplastin time (aPTT) Coagulation status analysis. After successful PTCA (performed via the right femoral artery with a 7 French sheath in all cases), the coagulation status [aPTT and prothrombin time (PT)] was analyzed. After discarding 10 ml of arterial blood via the arterial sheath, conventional coagulation monovettes (Sarstedt™) were used for this purpose. The blood sample was immediately taken to the clinic laboratory, whereupon coagulation was analyzed with an automatic coagulator (Boehringer™), in which Neoplastin plus an aPTT reagent (Boehringer) were used as reagents. No heparin was applied for the next 6 hours in either group. In group A, the femoral sheath was removed after 6 ± 2 hours using the FemoStop system after a second analysis of the coagulation status [aPTT(2) and PT(2)] according to the above-mentioned method. In group B, after the 6-hour heparin-free period, a continuous heparin infusion of 10 IU/kg body weight/hour was started to prevent deep vein thrombosis, and the femoral sheath was removed after 15 ± 3 hours using the FemoStop system after the coagulation status was measured. Six hours after PTCA, the incidence of early hematoma at the puncture site was documented in both groups. At this time, one patient from each group had a significant inguinal hematoma; both patients were excluded from femoral compression time analysis, but were included in the later overall documentation of the number of inguinal hematomas. Application of the FemoStop system. A fixing belt was applied under the patient’s thighs at the level of the puncture site while the sheath was still in place. The pressure arch was placed on the patient with the center of the pneumatic air cushion approximately 1 cm above the puncture site. The belt ends were inserted in the belt locks of the pressure arch. A manometer was connected to the inflatable pneumatic bubble via a short pressure hose. After the compression apparatus was centered, the air cushion pressure was rapidly increased and the sheath was simultaneously removed from its position under visual monitoring of the puncture site through the transparent air cushion. The air cushion was inflated to 30 mmHg above the patient’s systolic blood pressure, and this pressure (P = BP systolic + 30 mmHg) was held constant for 25 minutes. After this 25-minute period, the onset of hemostasis was checked at 5-minute intervals via short-term reduction of the air cushion pressure. If complete removal of the air cushion without post-operative bleeding was possible, the entire system was removed and a loose-fitting compression bandage was applied for the next 24 hours. The time until primary hemostasis was attained was defined as FSCT. After PTCA, the blood pressure was measured continuously for all patients and a continuous intravenous infusion of nitrates (2–8 mg/hour) was administered to ensure normotonic blood pressure values at the time of sheath removal. Patients with hypertensive blood pressure values (BP > 160/95 mmHg) at the time of sheath removal were primarily excluded. Thirty-six hours after PTCA, all patients underwent a clinical examination and the total incidence of hematoma at the puncture track was determined. For this purpose, hematomas were defined as inguinal accumulations of blood > 10 cm² accompanied by pain and relevant hematoma-induced swelling. All patients with a relevant inguinal hematoma and/or clinical suspicion of a false aneurysm were subjected to a duplex sonography of the Arteria femoralis to detect/rule out a false aneurysm. Statistical analysis. The statistical analyses of the inguinal compression times and of the aPTT and PT values were conducted using the Student’s paired test, and the analyses of the incidence of hematomas, vagal reactions and false aneurysms were performed with the Chi-square test. A p-value 4 g/dl were not observed in any case, nor were any reocclusions in the dilated coronary artery documented. Discussion Most therapeutic interventional procedures for coronary arteries are performed via the transfemoral approach, while various protocols exist for timing and mode of arterial puncture site closure. According to the literature,^2,4,6,10,13 the incidence of peripheral vascular complications, such as hematoma, is dependent on various factors such as the heparin anticoagulation status, femoral sheath, age and female sex. The scientific literature contains contradicting results with respect to the influence factors of arterial blood pressure and peripheral arterial vascular status (e.g., arterial occlusive disease).^4,6,10,13 It has not yet been investigated whether a relationship exists between heparinization and necessary compression time as a mechanical mode of compression. To analyze this relationship, we attempted to hold constant as many parameters with possible influence on the femoral compression time as possible. Only patients who were normotensive at the time of sheath removal and without peripheral arterial occlusive disease were included in this study. In all cases, coronary angioplasty was performed via the right femoral artery with a 7 French sheath, and both heparinization management and platelet aggregation therapy were standardized peri-interventionally. In contrast to manual compression, the use of the pneumatic pressure bubble allows control of a potentially important influence parameter on the closure time, namely, to keep the compression pressure relatively standardized and comparable. Therefore, patients with inguinal hematomas manifesting before FemoStop compression were primarily excluded, since larger inguinal accumulations of blood at the same air cushion pressure must cause a lower local compression pressure on the femoral artery. Taking into account the two patients who were excluded a priori because of inguinal hematoma, the total patient group had a hematoma incidence of 6.7%, which is comparable to the data reported in the literature.^1,3,5,6 A relevant relationship between heparin anticoagulation level and closure time of the arterial puncture site could be proven using the FemoStop system, which is important in every-day clinical practice. The more intense the heparinization, the longer the necessary compression time with the FemoStop system. This phenomenon is comprehensible when viewed from the perspective of coagulation physiology, since not only platelet aggregation but also plasmatic coagulation play important roles in hemostasis, due to the reduced effect of thrombin as a central coagulation enzyme by heparin.⁸ With early sheath removal (approximately 6 hours after PTCA), a relevant heparinization is still present, so the FemoStop compression time is significantly prolonged compared to late sheath removal in a normalized coagulation situation. The relatively long and thus sometimes painful compression period necessary for early sheath removal is stressful to the patient and is also accompanied by an increased incidence of vagal reactions. Therefore, in our opinion, only those patients in whom the aPTT is less than 80 seconds six hours after PTCA should be considered for early sheath removal. Late sheath removal (approximately 15 hours after PTCA) can be performed without concern after carefully carried out primary femoral artery puncture when the heparinization regimen used here is applied. In this study, it was not followed with an increased rate of peripheral vascular complications. The compression times are obviously shorter, and the procedure is more pleasant for the patient. However, publications by Friedmann et al.9 have shown that prolonged heparinization and late sheath removal after PTCA may be associated with an increased incidence of relevant bleeding complications in the inguinal region.¹⁴ In contrast, the occurrence of complications (post-operative bleeding after the system is removed, incidence of hematomas, false aneurysms) in our study population after late sheath removal was comparable to data on other modes of femoral artery closure (collagen plug, etc.) reported in the literature.^1,3,5 Compared to arterial puncture site closure via collagen application, the material costs for the FemoStop system are substantially lower. Moreover, the same vascular access can be used for control angiograms that become necessary very early after PTCA, which can be problematic with the percutaneously inserted collagen plug.¹ On the whole, based on our findings and the experience from over 3,000 coronary angioplasties performed at the Heart Centre of Wuppertal,^11,12 with respect to the use of the FemoStop system, the following recommendations can be made: 1) before femoral sheath removal and FemoStop application, the current heparin anticoagulation status (aPTT, better ACT) should be known¹¹ so that the necessary FemoStop compression time can be estimated; and 2) to obtain the shortest possible compression times, the aPTT should not be greater than 80 seconds and the sheath should not be removed too quickly after PTCA ( 400 seconds), or better yet, an alternative closure system (e.g., collagen plug) should be used a priori.^1,3,6,7Conclusion. Our data suggest that the FemoStop system is well suited for arterial puncture site closure after uncomplicated coronary angioplasty under inpatient conditions and can be recommended for use because of its simple handling and low material costs.