Comparison of Safety and Efficacy Between First and Second Generation of Angio-Seal Closure Devices in Interventional Patients

There are two principal approaches to achieve femoral artery hemostasis following diagnostic cardiac catheterization or percutaneous coronary intervention (PCI): manual compression or arterial closure devices.1–6 Arterial closure devices are safe and effective in selected patients, with complication rates similar to or lower than manual compression.7 There are two principal types of closure device: suture-based and plugs.8 The Angio-Seal closure device (Daig, Minnetonka, Minnesota) achieves hemostasis by anchoring a collagen plug to the anterior vessel wall through a sheath delivery system.9–11 Recently, a new generation of the Angio-Seal device (Angio-Seal STS Platform™) became available. The Angio-Seal STS simplifies the deployment process for the operator; by eliminating the post-placement spring, the procedure is concluded in the cath lab. Previous studies have shown that early (first) generation devices can be responsible for increased vascular complications.12 The purpose of this study is to compare the safety and efficacy of the first- and new-generation Angio-Seal devices in patients undergoing PCI. Methods Patients. A total of 140 patients, age > 18 years, undergoing PCI using the femoral approach between April 2001 and March 2002 were enrolled in the study. A total of 78 patients (55.7%) were treated with the new Angio-Seal STS device as part of a prospective registry, while a group of 62 patients (44.3%) represents a historical control from the institutional database matched for demographic and clinical variables. We excluded patients with thrombolytic therapy, acute ST-elevation myocardial infarction (MI) or sheath size > 8 French. PCI. Percutaneous revascularization was performed with standard techniques. Anticoagulation after sheath insertion was accomplished using intravenous unfractionated heparin to achieve a target activated clotting time (ACT) of 200–250 seconds. During data acquisition on the new Angio-Seal STS device, bivalirudin (Angiomax, The Medicines Company) became available and was used at operator discretion in place of unfractionated heparin. Bivalirudin was administered as a 0.75 mg/kg bolus followed by 1.75 mg/kg/hr infusion until the end of the PCI. All patients were treated with aspirin 325 mg daily. A loading dose of clopidogrel 150 mg was given, followed by 75 mg/day if the patient received stents. Patients who were allergic or intolerant to clopidogrel received a loading dose of ticlopidine 250 mg followed by 250 mg twice daily. Arterial closure. The hemostasis method (manual compression versus Angio-Seal) was left to the discretion of the attending interventionalist. Before Angio-Seal deployment, femoral arteriography was performed in all patients through the arterial sheath in both groups. The Angio-Seal device was not used in patients with: 1) an arteriotomy site at or below the femoral artery bifurcation; 2) common femoral artery size Data collection. A dedicated research coordinator was assigned to collect the data from the patient chart, hospital computerized database and cath lab reports. Patients were followed until discharge. Procedural information included procedure time, discharge time (defined as time from hospital admission until hospital discharge), ACT, heparin dose, bivalirudin and glycoprotein IIb/IIIa inhibitor use, devices used during PCI, deployment failure and inability to obtain hemostasis. Procedural success was defined as successful completion of PCI without major adverse cardiac events (MACE), i.e., death, ST elevation and non-ST elevation MI (CK-MB > 3 times normal), and emergent or urgent coronary artery bypass graft (CABG) surgery. Major vascular complications included post-procedural drop in hematocrit > 20%, hematoma > 5 cm, need for blood transfusion, retroperitoneal bleed, formation of arteriovenous fistula, pseudoaneurysm, need for surgical repair at the access site, and infection involving the access site requiring antibiotics. A hematoma Statistics. Continuous variables were expressed as means ± 1 standard deviation and compared with the unpaired Student’s t-test. Categorical variables were expressed as frequencies and compared with Chi-square statistics or Fisher’s exact tests; p-values 5 cm, drop in hematocrit > 20%, and blood transfusion in the two groups. There were no pseudoaneurysms, arteriovenous fistulas, retroperitoneal bleeds or infections. Discussion The major finding of this study is that the new Angio-Seal STS Platform can secure hemostasis after PCI in a safe and effective manner, similar to the old device. The new platform is easier for the operator and the patient. Arterial closure is performed in the catheterization lab and there is no post-placement spring to remove 20–30 minutes later. Patient comfort is improved without the spring, because the patient can move in the bed without concern about spring dislodgement. Earlier mobilization could shorten time to ambulation, which is known to increase patient satisfaction.8 Higher procedural ACT values were found to correlate with an increase in vascular complications in previous studies.13 Complication rates appear to be influenced by use of heparin, fibrinolytic therapy, arterial sheath size, age >= 65 years, and the presence of peripheral vascular disease.14 In our study, higher ACT values in the Angio-Seal STS group did not result in an increased number of vascular complications. Prolongation of ACT during PCI in the Angio-Seal STS group was entirely related to the use of bivalirudin. It has been reported that with the standard dosing regimen of bivalirudin (0.75 mg/kg bolus followed by 1.75 mg/kg/hr infusion), ACT values could be more than 150 seconds longer compared to those receiving UFH.15 However, in spite of higher ACTs in previous studies, ischemic and hemorrhagic complications were lower or similar (depending on the dosage) compared to UFH.13,16–19 The same is true for the current study. Rates of minor and major vascular complications and procedural outcomes were similar between groups and were similar to other studies.12,13 Closure device failure rate in our study was as low as or comparable to the data reported in the literature.12,13,20 This was true despite the fact that this study was performed early in operator experience with the new device. There were no infections during the study; the known infection rate is between 0–3%.3,8,20,21 Study limitations. The number of patients in both groups was small and the study was not randomized. Use of glycoprotein IIb/IIIa inhibitors was low in the study. Conclusion. The new generation of the Angio-Seal STS closure device, which permits faster and easier deployment, does not decrease the arterial closure success rate or increase vascular complications compared to the first generation of Angio-Seal.

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