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1 Original Acta Cardiol Sin 2007;23: The Efficacy and Safety of Angio-Seal Percutaneous Femoral Artery Closure Device after Diagnostic and Therapeutic Cardiac Catheterizations A Single Center s Experience Cheng-Han Lee,,2 Shu-Fen Hung, 3 Ju-Yi Chen, Ting-Hsin Chao, Yi-Heng Li, Li-Jen Lin and Liang-Miin Tsai Objective: The purpose of this study was to evaluate the safety and efficacy of a hemostatic puncture closure device (Angio-Seal Vascular Closure Device) in patients undergoing diagnostic and therapeutic cardiac catheterizations. Methods: All consecutive patients (n = 02) who received a hemostatic puncture closure device from January 2007 to May 2007 in the National Cheng Kung University Hospital were enrolled in the study. Of these, 45 (44%) patients received therapeutic cardiac catheterizations. Multivariate logistic regression analyses were used to determine the predictors of vascular complications. Results: Of 02 patients, there were 68 (67%) males, and the mean age was 67 years. All devices were deployed successfully, and device dysfunction occurred in only one patient (0.98%), in whom successful hemostasis was achieved later by manual and sandbag compression. There were 7 patients (6.7%) with small hematoma ( 6 cm in diameter) and three (2.9%) with large hematoma after the procedure. Compared with patients in the diagnostic group, patients in the therapeutic group had insignificantly higher complications of large hematoma (n = 3) (6.7% vs 0%, p = 0.08). However, no patients developed pseudoaneurysms, arteriovenous fistulae, and late bleeding in need of vascular repairs and blood transfusion until 7 to 4 days after discharge in both groups. Using multivariate logistic regression method, older age ( 75 years) was the only risk factor for developing large hematoma. Conclusion: Angio-Seal device offers a safe and effective hemostasis of the femoral artery in patients undergoing diagnostic and therapeutic cardiac catheterizations with acceptable morbidity rates. Key Words: Angio-Seal device Femoral artery puncture Cardiac catheterization Complications INTRODUCTION Received: June 8, 2007 Accepted: September 0, 2007 Division of Cardiology, Department of Internal Medicine, National Cheng Kung University Hospital; 2 Institute of Clinical Medicine, School of Medicine, National Cheng Kung University; 3 Nursing Department of National Cheng Kung University Hospital, Tainan, Taiwan. Address correspondence and reprint requests to: Dr. Liang-Miin Tsai, Professor of Internal Medicine, Department of Internal Medicine, National Cheng Kung University Hospital, No. 38 Sheng-Li Rd., Tainan 70428, Taiwan. Tel: ext. 2389; Fax: ; appollolee@yahoo.com.tw Femoral artery access is still the most widely used for diagnostic and therapeutic cardiac catheterization; however, it may require manual compression at the vascular access site with or without the use of adjunctive compression tools. Also, patients need prolonged bed rest, which results in discomfort, longer hospital stay and additional costs. Reported vascular complication occurs in 0.8% to.8% of diagnostic cardiac catheterizations and.5% to 9% of percutaneous coronary inter- 247 Acta Cardiol Sin 2007;23:247 53

2 Cheng-Han Lee et al. catheter to maintain an activated clotting time (ACT) between 250 and 300 seconds. Blood samples for ACT measurements were obtained at the end of the procedure. Patients receiving intracoronary stents would receive aspirin mg/day and clopidogrel 300 mg as a loading dose followed by 75 mg/day if there were no contraindications. vention (PCI) cases when performed via transfemoral access, and 20% to 40% of these patients who experience such complications require surgical repair.-5 Since the introduction of vascular closure devices, the efficacy and safety of these devices have been evaluated.6-8 A recent meta-analysis of 30 randomized trials showed that there is only marginal evidence that arterial puncture closing devices are effective and they may increase the risk of hematoma and pseudoaneurysm.9 The frequent use of antiplatelet and anticoagulant agents in PCI cases usually has higher rate of vascular complications. Therefore, we sought to compare the efficacy and safety of the Angio-Seal Vascular Closure Device (St. Jude Medical, St Paul, MN) in patients undergoing diagnostic and therapeutic cardiac catheterizations in this referred medical center. Femoral artery closure Following successful diagnostic catheterization or PCI procedures, hemostatic puncture closure was then achieved using the Angio-Seal Vascular Closure Device. If cardiologists had suspicion of unusual puncture site, a femoral arteriogram would be performed via the arterial sheath. Patients generally did not undergo arterial closure if the arteriostomy site was at or below the common femoral artery bifurcation, extensively calcified, or significantly stenotic (< 5 mm in diameter). The Angio-Seal device consists of an absorbable plug component and delivery system (Figure ). Initial arterial sheaths with size 7F were used in all patients, and delivery of the device was then initiated by first exchanging the existing sheath over a wire for an 8F sheath. The carrier tube containing the plug was inserted through the sheath. After ensuring the carrier tube in the arterial lumen, the anchor was deployed. The sheath and carrier tube assembly was then retracted (Figure ), maintaining tension on the assembly while pushing down the temper tube for 0 seconds. MATERIALS AND METHODS Study population The study was conducted at the cardiac catheterization laboratory, National Cheng Kung University Hospital, in southern Taiwan. Patients in our institution undergoing diagnostic cardiac catheterization or PCI using the femoral artery approach were included in the study. Patients were not eligible for a percutaneous femoral artery closure device if they had peripheral arterial occluded disease, presence of ST-segmental elevation myocardial infarction, presence of hematoma before sheath removal, or suspicion of profunda femoris puncture. Finally, a total of 02 diagnostic catheterization and PCI procedures between January 2007 and May 2007 were retrospectively enrolled. There were 45 patients (44%) experiencing PCI procedures and the others received only diagnostic cardiac catheterizations. Cardiac catheterization and PCI procedures Diagnostic cardiac catheterization and PCI procedures were performed via the percutaneous femoral approach using 7 French introducers and guide catheters. Our cardiovascular fellows performed the arterial puncture. If patients just received diagnostic procedures, we did not give heparin during the procedure. If patients received elective PCI procedures, we routinely gave 0000 U heparin into the coronary artery through the guiding Acta Cardiol Sin 2007;23: Figure. The Angio-Seal hemostatic puncture closure device. The Angio-Seal device consists of a delivery system (A and B) and an absorbable plug component (C). After the sheath and carrier tube assembly is retracted, the device creates a mechanical seal by sandwiching the arteriotomy between a bio-absorbable anchor and collagen sponge (D). 248

3 Experience with Angio-Seal Device in Taiwan The device created a mechanical seal by sandwiching the arteriotomy between a bio-absorbable anchor and collagen sponge. Efficacy and safety of the Angio-Seal device The efficacy of the Angio-Seal device is defined by the ability of the device to cover the arteriotomy site and stop bleeding after the deployment. Procedure failure is defined as immediate hematoma formation and necessity of manual and sandbag compression after the deployment. The safety end points included vascular complications, as follows: groin bleeding (defined as blood loss at the access site resulting in blood transfusion, drop in hemoglobin > 3 g/dl, or late bleeding), large hematoma (> 6 cm in diameter), vascular injury (need for vascular repair, pseudoaneurysm, arteriovenous fistula, acute limb ischemia). In our hospital, vascular ultrasound investigation of the femoral artery was performed only when there was clinical suspicion of a vascular complication. Follow-up of patients after discharge was done at 7 to 4 days. Statistical analysis We analyzed the data using SPSS 2.0 software (SPSS Inc., Chicago, Illinois). Data are expressed as mean standard deviation, or percentage. The 2 test was used for comparisons of categorical data, and the two-tailed Student t test was used to compare continuous variables. The multiple regression analysis using a stepwise forward regression model in which each variable with a P value < 0. in the univariate analysis for predicting vascular complications was entered into the model. All reported P-values are two-tailed, and statistical significance was set at P < RESULTS Baseline characteristics of the 02 study patients, of which 45 (44%) underwent percutaneous coronary intervention and 57 (56%) underwent diagnostic cardiac catheterization, are listed in Table. In the therapeutic group, male patients significantly predominated, and higher percentages of diabetes mellitus were found. Before catheterizations, there were no laboratory differences between these two groups. Furthermore, the mean procedure duration was significantly longer and activated clotting time was significantly greater in patients undergoing PCI (Table ). Immediately before device deployment, the systolic blood pressure and pulse rate were similar in both groups (Table ). Higher percentages of patients received combination anti-platelet therapy in the PCI group. No patients received intravenous GP IIb/IIIa receptor inhibitor after the PCI procedures. Table 2 describes the vascular complications in both groups. Fourteen patients (3.7%) had mild groin oozing immediately after the device was deployed; however, oozing was quickly stopped by manual pressure within 5 minutes. All devices were successfully deployed. However, there was one procedure failure. Immediate swelling and active bleeding after the deployment developed in one patient. After manual pressure and sandbag compression for 6 hours, hemostasis was achieved successfully. Although we reported any hematoma, including small size ( 6 cm in diameter), only large hematoma (> 6 cm in diameter) was regarded as a vascular complication. The overall vascular complication rate was insignificantly lower in the diagnostic catheterization group as compared with the PCI group (0% vs 6.7%, n = 3, p = 0.08). Table 3 describes the detailed data for patients developing large hematoma. These complications occurred among the first 30 patients, but werenot observed in the next 72 patients. In addition, nobody developed other vascular complications in need of blood transfusion and vascular repairs. All patients received follow-up between 7 and 4 days after discharge and they were examined for the puncture site, including hematoma, thrills, and bruits. No additional vascular complications were found in either group during the period. Multivariate logistic regression models for determining predictors of vascular complications showed that older age ( 75 years) was the only independent risk factor (odds ratio:.3; 95% confidence interval:.0~.7, p = 0.05). DISCUSSION This study documented the use of the Angio-Seal Vascular Closure Device as a means of achieving early hemostasis following diagnostic and therapeutic cardiac catheterization in selected patients. The device was successfully deployed in all study patients, and only one de- 249 Acta Cardiol Sin 2007;23:247 53

4 Cheng-Han Lee et al. Table. Baseline clinical characteristics in 02 adult patients Features Overall n 02 Therapeutic n 45 Diagnostic n 57 P value Demographics Mean age, years Male 68% 78% 58% 0.04 Hypertension 69% 80% 6% Diabetes mellitus 38% 49% 29.% 0.04 Renal insufficiency 0.3% 8.9% 4% 0.54 Hemodialysis 08.2% 8.9% 8.8% Dyslipidemia 33% 33% 30% 0.83 CVA 2.4% 3.3% 0.5% 0.76 Smoking 28% 29% 28% Heart failure 9% 4.4% 29.8% Body mass index Laboratory data WBC, mm Hemoglobin, mg dl Platelets, mm PT, seconds APTT, seconds BUN, mg dl Creatinine, mg dl Medications Aspirin 79% 84% 75% 0.33 Clopidogrel 64% 93% 40% Warfarin 2.% 0 3.5% 0.50 Before device deployment ACT, seconds Systolic BP, mmhg Heart rate, minute Procedure*, minutes CVA means cerebrovascular accident, which includes ischemic stroke and hemorrhagic stroke; ACT activated clotting time; *stands for the procedure duration from successful arterial puncture to Angio-Seal deployment. Table 2. Vascular complications Complications Therapeutic group (n 45) Diagnostic group (n 57) P value Small hematoma ( 6cm) 9(20%). 8 (4%) 0.44 Largehematoma( 6cm) 3(6.7%) Procedure failure (2.2%) Pseudoaneurysm Arteriovenous fistula Retriperitoneal hemorrhage Acute limb ischemia Surgical repairs vice was dysfunctional. We did not observe any adverse cardiac events and major vascular complications in need of vascular repairs and blood transfusion during the follow-up periods. There seemed to be a learning curve for Angio-Seal device deployment in this study. Vascular complications at the access site always lead Acta Cardiol Sin 2007;23:

5 Experience with Angio-Seal Device in Taiwan Table 3. Detailed data for 3 patients developing large hematoma after device deployment Patient number 2 3 Sex Male Male Female Age, years BMI PT, seconds aptt, seconds Platelets, 0 3 mm Creatinine, mg dl Single antiplatelet use - Yes Yes Double antiplatelet use Yes - - Indication for catheterization Stable angina AMI Stable angina Procedure duration*, minutes ACT, seconds BMI means body mass index; AMI, acute myocardial infarction and *stands for the procedure duration from successful arterial puncture to Angio-Seal deployment. to prolonged hospital stay, increased costs, and patient discomfort. Although manual compression is effective in achieving hemostasis in most patients, it takes 5-20 minutes to compress the puncture site followed by 4- to 6-hour bed rest. Reported vascular complications occur in 0.8% to.8% of diagnostic cardiac catheterizations and.5% to 9% of percutaneous coronary intervention cases when performed via transfemoral access. -5 The drawbacks of manual compression have led to a search for methods of puncture site hemostasis that are more comfortable and effective for both physicians and patients. Since the introduction of vascular closure devices, the FDA has approved several devices for use in clinical practice, and the Angio-Seal Vascular Closure Device is one of them. 0-2 The present study showed that the risk of vascular complications was none in the diagnostic group and 6.7% in the therapeutic group, which is comparable with previously published literature. The Angio- Seal device was effective in achieving hemostasis in 99% of patients. One patient had active groin bleeding and a large hematoma immediately. An efficacy of 95-00% exists in different reports. -5 Our final results were all satisfying because manual compression was effective in achieving hemostasis without any further complications. No serious vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal hemorrhage, and surgical repairs, were observed in our study. However, a large-sample study reported that the rate of serious vascular complications was around 0.2% in the diagnostic group and 0.7% in the therapeutic group. 7 In our series, multivariate logistic regression method for determining predictors of vascular complications showed that older age ( 75 years) was the only independent risk factor. The frequent use of antiplatelet or anticoagulant agents created a tendency to an increased rate of access site complications by manual compression. Although patients in the therapeutic group had higher tendency of wound bleeding such as higher activated clotting time, longer procedure duration, and higher percentages of antiplatelet use, the occurrence of vascular complications seemed to be not related to these factors. The Angio-Seal device consists of an anchor composed of a polylactide and polyglycolide polymer, a collagen plug, and suture contained within a special carrier system. If appropriately inserted, the device achieves hemostasis by mechanically compressing the arteriotomy site between the anchor and the collagen plug. Because the collagen plug instead of vessel wall itself seals off the puncture hole, antiplatelet and anticoagulant therapy will not increase the rate of vascular complications. A recent study also found that older age ( 70 years) was an independent predictor of vascular complications. 7 Although older age is not a contraindication, we should be very careful when applying the Angio-Seal device in these patients. We are not sure why older patients have higher incidences of major hematoma. We infer that the agglutination between the vessel wall and device s collagen plug in older patients may decrease. According to our experience, when we retract the sheath and carrier tube assembly, we should maintain tension on the assem- 25 Acta Cardiol Sin 2007;23:247 53

6 Cheng-Han Lee et al. bly while pushing down the temper tube for more than the recommended 0 seconds. Furthermore, if blood oozes from the puncture site after the Angio-Seal device deployment, applying short-duration manual pressure is safe and may decrease vascular complications. This study has several limitations. Its size did not allow for the evaluation of rare vascular complications such as pseudoaneurysm, arteriovenous fistula, and acute limb ischemia. We did not know the duration from the initial arterial puncture to successful sheath placement, which may affect the size of the hematoma after Angio- Seal device deployment. We did not do routine vascular ultrasound in every patient during the follow-up period. However, we would perform the vascular duplex if thrills, bruits, or large hematoma were detected. In conclusion, Angio-Seal Vascular Closure Device deployment is an easy, safe, and effective tool to achieve quick hemostasis. Even in patients undergoing therapeutic cardiac catherterizations, the complications of the puncture site are acceptable. We should be very careful when implanting this device in the elderly. REFERENCES. Nasser TK, Mohleri ER, Wilensky RL, Hathaway DR. Peripheral vascular complications following coronary interventional procedures. Clin Cardiol 995;8: Applegate R, Grabarczk M, Little W, et al. Vascular closure devices in patients treated with anticoagulation and IIb/IIIa receptor inhibitors during percutaneous revascularization. JAmColl Cardiol 2002;40: Resnic F, Blake G, 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 200;88: Waksman R, King SB, Douglas JS, et al. Predictors of groin complications after balloon and new-device coronary intervention. Am J Cardiol 995;75: Omoigui N, Califf R, Pieper K, et al. Peripheral vascular complications in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I). J Am Coll Cardiol 995;26: Aksoy M, Becquemin JP, Desgranges P, et al. The safety and efficacy of Angioseal in therapeutic endovascular interventions. Eur J Vasc Endovasc Surg 2006;32: Arora N, Matheny ME, Sepke C, Resnic FS. A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices. Am Heart J 2007;53: Ward SR, Casale P, Raymond R, et al. Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography. Am J Cardiol 998;8: Koreny M, Riedmuller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA 2004;29: Gerckens U, Cattelaens N, Lampe EG, et al. Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device. Am J Cardiol 999;83: Amin FR, Yousufuddin M, Stables R, et al. Femoral haemostasis after transcatheter therapeutic intervention: a prospective randomized study of the Angio-Seal device vs. the FemoStop device. Int J Cardiol 2000;76: Duffin DC, Muhlestein JB, Allisson SB, et al. Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invasive Cardiol 200;3: Acta Cardiol Sin 2007;23:

7 Original Acta Cardiol Sin 2007;23: 在診斷和治療性心導管後使用 Angio-Seal 動脈黏合器之有效度及安全性,2 李政翰 3 洪淑芬 陳儒逸 趙庭興 李貽恆 林立人 台南市國立成功大學醫學院附設醫院內科部心臟內科 台南市國立成功大學醫學院臨床醫學研究所 2 台南市國立成功大學醫學院附設醫院護理部 3 蔡良敏 目的本研究目的在評估做完診斷和治療性心導管後使用 Angio-Seal 動脈黏合器的有效度和安全性的比較 方法從 2007 年一月至 2007 年五月, 共有 02 位病人在國立成功大學附設醫院接受完診斷或治療性心導管後使用 Angio-Seal 動脈黏合器 其中, 有 45 (44%) 位病人同時接受診斷和治療性心導管 利用多變數回歸分析方法找出使用 Angio-Seal 動脈黏合器後會發生血管併發症的危險因子 結果 02 位病人的平均年齡為 67 ± 歲而有 68 (67%) 位男性 所有 Angio-Seal 動脈黏合器都被成功植入, 但是有一個 (0.98%) 病人在放完動脈黏合器後並無法立即止血, 必須以手壓止血及後續使用沙袋加壓後才成功獲得止血 在之後出院前追蹤中, 共有 7 (6.7%) 位病人出現小血腫 ( 直徑 6 公分 ) 及 3 (2.9%) 位病人出現大血腫 ( 直徑 > 6 公分 ) 與接受診斷性心導管的病人比較起來, 接受治療性心導管的病人似乎有較高比例會出現大血腫 (3 位 ) (6.7% vs 0%, p = 0.08), 不過並無統計學的意義 但是, 在後續出院後 7 至 4 天的追蹤中並沒有任何病人發生重大血管併發症需要手術治療或輸血, 包括假血管瘤 動靜脈瘻管 延遲傷口出血 利用多變數回歸分析方法找出年老 ( 年紀 75 歲 ) 是唯一在使用 Angio-Seal 動脈黏合器後會出現大血腫的危險因子 結論接受完診斷或治療性心導管後使用 Angio-Seal 動脈黏合器都可以安全並有效的讓股動脈止血, 而它所造成的血管併發症是可以接受的 關鍵詞 :Angio-Seal 動脈黏合器 股動脈穿刺 心導管手術 併發症 253