Access Site Pseudoaneurysms After Endovascular Intervention for Peripheral Arterial Diseases
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ORIGINAL ARTICLE pISSN 2288-6575 • eISSN 2288-6796 https://doi.org/10.4174/astr.2019.96.6.305 Annals of Surgical Treatment and Research Access site pseudoaneurysms after endovascular intervention for peripheral arterial diseases Ahmed Eleshra1,2, Daehwan Kim1, Hyung Sub Park1,3, Taeseung Lee1,3 1Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea 2Department of Vascular Surgery, Faculty of Medicine, Mansoura University Hospital, Mansoura, Egypt 3Department of Surgery, Seoul National University College of Medicine, Seoul, Korea Purpose: Pseudoaneurysms after percutaneous vascular access are common and potentially fatal if left untreated. The aim of this study was to determine the incidence and risk factors associated with access site pseudoaneurysms after endovascular intervention for peripheral arterial disease (PAD) under a routine postintervention ultrasound (US) surveillance protocol. Methods: A total of 254 PAD interventions were performed in a single center between January 2015 and November 2016, and puncture site duplex US surveillance was routinely performed within 48 hours of the procedure. Clinical, procedural and follow-up US data were analyzed. Results: The overall incidence of pseudoaneurysm was 2.75% (6 cases in the femoral artery and 1 in the brachial artery). There was no difference between retrograde and antegrade approach, but there was a higher rate of pseudoaneurysm formation after manual compression compared to arterial closure device (ACD) use (4.3% vs. 0.87%). Manual compression was more commonly used for antegrade punctures (79.0%) and ACD for retrograde punctures (67.7%). Calcification was more frequently found in antegrade approach cases (46.8% vs. 16.9% for retrograde cases) and manual compression was preferred in its presence. All pseudoaneurysms were treated successfully at the time of diagnosis by US-guided compression repair and there were no cases of rupture. Conclusion: Pseudoaneurysm rates after therapeutic endovascular intervention for PAD were comparable to other cardiologic or interventional radiologic procedures despite the higher possibility of having a diseased access vessel. Routine US surveillance of access sites allowed for early diagnosis and noninvasive treatment of pseudoaneurysms, preventing potentially fatal complications. [Ann Surg Treat Res 2019;96(6):305-312] Key Words: False aneurysm, Vascular closure devices, Endovascular procedures, Complications, Peripheral arterial disease INTRODUCTION must be sealed at the end of the procedure. Failure to seal adequately can lead to puncture-related complications, which Percutaneous endovascular revascularization is an estab- may include groin hematoma, pseudoaneurysm, arteriovenous lished and highly accepted therapy for peripheral arterial fistula, thrombosis, and dissection. Excessive bleeding from diseases (PAD) [1]. It requires deliberate arterial puncture for the puncture site can be fatal and therefore must not be access, most commonly the common femoral artery, which underestimated, but in some cases of retroperitoneal bleeding, Received October 5, 2018, Revised March 1, 2019, Copyright ⓒ 2019, the Korean Surgical Society Accepted March 28, 2019 cc Annals of Surgical Treatment and Research is an Open Access Journal. All Corresponding Author: Taeseung Lee articles are distributed under the terms of the Creative Commons Attribution Non- Department of Surgery, Seoul National University Bundang Hospital, 82 Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which Gumi-ro 173 beon-gil, Bundang-gu, Seongnam 13620, Korea permits unrestricted non-commercial use, distribution, and reproduction in any Tel: +82-31-787-7092, Fax: +82-31-787-4078 medium, provided the original work is properly cited. E-mail: [email protected] ORCID code: https://orcid.org/0000-0001-6425-5924 Annals of Surgical Treatment and Research 305 Annals of Surgical Treatment and Research 2019;96(6):305-312 early diagnosis can be missed. The rate of puncture-related degree of calcification at the access site (grades 1–4 according complications has been reported to range from 1.5% to 9%, to the peripheral arterial calcium scoring system) [8] method and surgical repair is required in 20%–40% of these cases [2,3]. of hemostasis, and type of arterial closure device used. We Furthermore, these complications can lead to longer length of excluded 19 cases that had not undergone follow-up duplex US hospitalization, increased patient discomfort and an increase after the intervention. Additionally, groin hematomas were not in socioeconomic burden. Pseudoaneurysms are one of the included in this study due to the benign nature of progression. trouble some complications that can rupture if left untreated. The study was approved by the Institutional Review Board of Some society guidelines have recommended an acceptable rate Seoul National University Bundang Hospital (IRB No. B-1801-442- of <0.2%, but the reported rates of femoral pseudoaneurysm in 105), and informed consent was waived due to the retrospective the literature vary from as low as 0.2% to up to 3.8% of patients nature of the study. when routine duplex ultrasound (US) imaging was performed. [4,5]. Procedure Manual compression of the access site is the most widely All endovascular interventions were performed in a hybrid accepted and cost-effective method of achieving hemostasis operation room equipped with a bi-planar fixed C-arm. All after endovascular intervention, but it is claimed to be time procedures were therapeutic in nature and diagnostic cases consuming and uncomfortable for the patients. Additionally, its were not included in this study. Access was obtained using mechanism of hemostasis does not lead to direct closure of the the Seldinger technique under ultrasound-guidance and a vessel, and therefore it is more prone to bleeding complications, micropuncture set with a 21-gauge needle was used routinely especially if patient cooperation is suboptimal. In order to for all cases. Areas of calcification were avoided during puncture overcome these drawbacks, arterial closure devices have been whenever possible. The direction of access was retrograde for developed to directly seal the punctured artery. Their efficacy iliac and aortic pathologies or crossover interventions, while has been proven by many previous studies, and they are antegrade approach was used for femoro-popliteal or below-the- nowadays widely used, with the advantage of being comfortable knee interventions. Patients were anticoagulated routinely with for both the patient and the physician, and allowing for early unfractionated heparin with dosage based on body weight and mobilization and recovery. However, their cost and their endovascular procedures were performed by an experienced indications for use may preclude their routine use in daily vascular interventionist with good expertise in endovascular practice. Therefore the risks and benefits of arterial closure intervention. devices remain a source of controversy [6,7]. The aim of this study was to report the rate of puncture- Access site management after intervention related pseudoaneurysm formation after therapeutic endo- Arterial sheaths were routinely removed in the operation vascular intervention for PAD in a population where routine room and hemostasis was achieved either by manual duplex US surveillance was performed the next day after the compression or by use of arterial closure devices. The method intervention. Additionally, the risk factors associated with of hemostasis was mainly decided on the basis of physician pseudoaneurysm formation were determined, with special preference, but manual compression was preferred for small attention to puncture direction and method of hemostasis. caliber sheaths or for heavily calcified access sites. Manual compression was performed by the first assistant for at least METHODS 20–30 minutes, a compression bandage was then applied, and patients were advised to stay immobilized for at least 6–8 hours We retrospectively reviewed a prospectively collected after the procedure. For ACDs, the puncture sites and gloves data of 273 cases that underwent therapeutic endovascular were sterilized with chlorhexidine solution before application intervention for occlusive and nonocclusive diseases of the of the devices, and arterial closure was performed according peripheral arterial system from January 2015 to November to the instructions for use of each device. The ACDs used were 2016. The primary aim of this study was to determine the the Perclose ProGlide (Abbott Vascular Inc., Santa Clara, CA, rate of puncture-related pseudoaneurysm formation based on USA), FemoSeal (St. Jude Medical, St. Paul, MN, USA), StarClose a routine duplex US surveillance protocol the next day after (Abbott) and Mynx (Cardinal Health, Dublin, OH, USA). In these the initial intervention. The patients’ clinical characteristics, patients, bed rest for 4 hours after closure was recommended. including medications (antiplatelet and anticoagulation agents), comorbidities and etiology of the disease were analyzed Duplex ultrasound examination from electronic medical records. Procedural details were also Duplex US was performed routinely the next day after evaluated, which included the site of puncture, direction of endo vas cular intervention by registered vascular technicians access (antegrade vs. retrograde), sheath size, heparin dosage, in a noninvasive vascular lab. For the femoral artery, the US 306 Ahmed Eleshra, et al: Pseudoaneurysms