Initial Experiences of Removal of Intra-Aortic Balloon Pumps with the Angio-Seal‚Ñ¢

The Angio-Seal™ Hemostatic Puncture Closure Device (St. Jude Medical, St. Paul, Minnesota) uses a biodegradable anchor and resorbable collagen plug to achieve local hemostasis after cardiac catheterization with up to 8 Fr arterial sheaths. Many investigators have revealed the efficacy of this device in achieving adequate hemostasis as compared to traditional manual pressure techniques.^1–3 There are a couple types of vascular devices that use collagen plugs, e.g., VasoSeal® (Datascope Interventional Products, Mahwah, New Jersey) and Angio-Seal. Vasoseal consists of a collagen plug deposited immediately outside the arterial wall. In contrast, Angio-Seal produces a sandwich closure between a footplate that sits against the inner arterial wall and a collagen plug outside the artery, which results in a more certain attachment than is achieved with the Vasoseal device.⁴ Although the diameter of the catheters used in the intra-aortic balloon pump (IABP) technique have become smaller in the past decade — down to 8 Fr or 7 Fr — vascular complications caused by the inadequate arterial closure after the removal of an IABP, including bleeding, hematoma and pseudoaneurysms, have been reported to occur.^5,6 It has already been reported that the VasoSeal is safe and effective for achieving hemostasis after removal of an IABP.⁷ However, it has not been clarified whether the Angio-Seal is effective for removing an IABP. We therefore investigated whether the Angio-Seal could be used safely and could achieve hemostasis rapidly when removing an IABP. Materials and Methods Study population. We prospectively studied 18 consecutive patients [age: mean 59.7 years (28–82 years), 15 males] in which the Angio-Seal device was planned to be used to achieve vascular hemostasis after the removal of an IABP between August and December 2004 in the intensive and cardiac care unit of Nippon Medical School. The exclusion criteria included age 8 A 0.20 inch guidewire was inserted through the central lumen of the IABP, and both the IABP and sheath were gently removed. The Angio-Seal sheath was inserted through the attached guidewire. Then the guidewire was exchanged for the 0.38 inch guidewire provided in the Angio-Seal kit. During the guidewire exchange, the Angio-Seal sheath was inserted to a suitable position. After determining the correct position of the sheath, the insertion system was introduced through the sheath, and the anchor was placed against the inner arterial wall. By retracting the entire device, the anchor and collagen sponge were drawn together, sandwiching the arteriotomy, and the collagen sponge was then tamped further down onto the outer arterial wall by a plastic tube. Finally, a metallic spring maintained controlled tension on the collagen for approximately 45 minutes and was taken off in the absence of oozing of blood. Study endpoint. The primary endpoint was a composite of any type of major and minor vascular complications. We defined major complications as retroperitoneal bleeding, vessel occlusion, loss of distal pulses, vascular surgery and death. Minor complications were hematoma (> 10 cm), AV fistula or pseudoaneurysm. The secondary endpoints were successful technical deployment of the device and immediate hemostasis without the need for additional treatment by manual compression. This protocol was the same technique utilized in a previous study on Angio-Seal after cardiac catheterization procedures.⁹ Technical success was defined as successful deployment of the device with immediate hemostasis achieved by the absence of bleeding immediately after the application of the closure device. The time to achieve hemostasis was also assessed in all patients. It was defined as the time that elapsed from the removal of the IABP until the tension spring was placed. Note: We have no financial interest in the products or companies relevant to this research. All materials were purchased with our research budget. Results We enrolled 18 consecutive patients who needed IABP support, and of those, 16 patients received the Angio-Seal to achieve vascular hemostasis after removal of the IABP. Two patients were excluded due to massive hematomas prior to IABP removal. The baseline characteristics of the 16 patients are shown in Table 1. An IABP was inserted in 9 patients with cardiogenic shock due to acute myocardial infarction. Four patients had congestive heart failure, 2 patients had uncontrolled angina pectoris before coronary bypass surgery and 1 patient had ventricular fibrillation. An 8 Fr IABP was inserted in 11 patients, and a 7 Fr system in 5 patients. IABP counterpulsation was continued for 1–5 days (mean 2.7 days). The Angio-Seal device was successfully deployed in all patients. The time-to-hemostasis was 2–5 minutes (mean 3.3 minutes). There were no instances of major bleeding, vessel occlusion or vascular surgery during the 7 days in any of the patients. Although 12 patients (66%) were treated with antiplatelet medications (aspirin alone: 4 patients; aspirin and ticlopidine: 3 patients; aspirin, ticlopidine and cilostazol: 5 patients), no patient required additional compression. Discussion This is a first report of an initial experience of removal of an IABP using the Angio-Seal device. We also found the time to achieve hemostasis to be shorter compared not only to traditional manual compression, but also to any other device. It was reported that the Angio-Seal device allowed for an earlier time-to-hemostasis and ambulation compared to conventional manual compression techniques after cardiac catheterization.³ The complication rates were similar for Angio-Seal and manual compression.^3,9 Conventional treatment of the femoral access site after cardiac catheterization, including manual compression and pressure bandages, is associated with prolonged immobilization and significant patient discomfort.¹⁰ Immediate removal of the arterial sheath after the procedure improves patient comfort. When the Angio-Seal is utilized to achieve hemostasis after removal of an IABP, similar benefits may be realized. Although we did not restrict our patients’ position after removing the spring, there were no complications. Therefore, using the Angio-Seal device may lessen the waiting time after the removal an IABP. The safety and efficacy of the VasoSeal device in achieving hemostasis after IABP removal has been reported.⁷ The VasoSeal is a collagen-based vascular closure device similar to the Angio-Seal. Vasoseal consists of a collagen plug deposited just outside the arterial wall; on the other hand, the Angio-Seal produces a sandwich closure. Thus, it may be easier to deploy and provide a more secure and effective hemostasis than with VasoSeal. The Angio-Seal device does not treat the subcutaneous tract. The VasoSeal requires that the subcutaneous track be enlarged to 11.5 Fr, thereby adding additional trauma, whereas the Angio-Seal is delivered through an 8 Fr sheath. The removal of the IABP using VasoSeal takes 8–17 minutes (mean 12.5 minutes),⁷ and it takes 2–5 minutes (mean 3.3 minutes) with the Angio-Seal in the present study, suggesting that the Angio-Seal might be easier to use. Despite the implantation of an intravascular foreign body, we did not observe any infectious complications. However, repeat sterilization of the puncture site should be applied and strict sterile deployment of the device is required in order to minimize the risk of infectious complications. This study was small and therefore needs to be confirmed by a large-scale study. The 16 patients in our study did not develop infections. We carefully confirmed that there was no infection at the puncture site and gently disinfected it many times under the direction of the guidelines for the prevention of intravascular catheter-related infections⁸ which mention that catheter replacement over a guidewire has become an accepted technique for replacing malfunctioning catheters or for exchanging a pulmonary artery catheter for a central venous catheter. In the present study, heparin was discontinued to reduce the risk of bleeding. In a previous study on VasoSeal with IABP removal, the IABP was removed when the ACT was 7 It has also been reported that the Angio-Seal could be used safely after catheterization in patients treated with anticoagulants and glycoprotein IIb/IIIa receptor inhibitors^9,11 In our study, 66.7% of the patients were treated with antiplatelet therapy and we had no complications. Thus, the Angio-Seal may allow for an earlier time-to-hemostasis and safe use. This was a small, nonrandomized study evaluating a novel approach in which the Angio-Seal device was used to achieve hemostasis when removing an IABP. The success rate of this procedure may partly depend on the skill of the operator. Further study will be necessary to elucidate the safety and full benefits of utilizing the Angio-Seal device in this patient population in order to be able to recommend its routine use in the removal an IABP.

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