Audit on the Complication Rates of Angioseal Vascular Closure Devices

Transcription

1 Audit on the Complication Rates of Angioseal Vascular Closure Devices Poster No.: C-1359 Congress: ECR 2014 Type: Authors: Keywords: DOI: Scientific Exhibit S. Abdulla, H. Rafiee, M. Crawford; Norwich/UK Complications, Angioplasty, CT-Angiography, Catheter arteriography, Interventional vascular, Vascular, Puncture, Hemorrhage, Embolism / Thrombosis, Dissection /ecr2014/C-1359 Any information contained in this pdf file is automatically generated from digital material submitted to EPOS by third parties in the form of scientific presentations. References to any names, marks, products, or services of third parties or hypertext links to thirdparty sites or information are provided solely as a convenience to you and do not in any way constitute or imply ECR's endorsement, sponsorship or recommendation of the third party, information, product or service. ECR is not responsible for the content of these pages and does not make any representations regarding the content or accuracy of material in this file. As per copyright regulations, any unauthorised use of the material or parts thereof as well as commercial reproduction or multiple distribution by any traditional or electronically based reproduction/publication method ist strictly prohibited. You agree to defend, indemnify, and hold ECR harmless from and against any and all claims, damages, costs, and expenses, including attorneys' fees, arising from or related to your use of these pages. Please note: Links to movies, ppt slideshows and any other multimedia files are not available in the pdf version of presentations. Page 1 of 10

2 Aims and objectives Background Vascular closure devices have been established as safe alternatives to manual compression for obtaining haemostasis after interventional vascular procedures. Fig. 2: Technique for using an Angioseal vascular closure device. References: Devriendt A et al. (2009) Ease of Using a Dedicated Percutaneous Closure Device after Inadvertent Cannulation of the Subclavian Artery: Case Report. Case Rep Med Versus manual compression they have been shown to provide faster haemostasis with no significant difference in complication rates. However, there is a risk of deployment failure and they incur an extra cost. A systematic review and meta-analysis (Das et al, 2011) and a worldwide registry (Reekers et al, 2011) have investigated complication rates - these will be used as the standard in our audit. Aims 1. To compare our department's Angioseal complication rates with those in the published literature. Page 2 of 10

3 2. To ensure that the use of an Angioseal device is always mentioned in the formal report of the interventional procedure. 3. To re-audit the results to assess whether there has been an improvement in our practice. Images for this section: Fig. 2: Technique for using an Angioseal vascular closure device. Page 3 of 10

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5 Fig. 1: Angioseal device Page 5 of 10

6 Methods and materials A retrospective audit was performed on patients who had undergone interventional procedures where an Angioseal vascular closure device was used for haemostasis. The report on our PACS system, follow-up investigations and patient discharge letters were reviewed for evidence of post-procedure complications. Where there were complications the clinical notes were reviewed to assess the clinical impact. The initial audit period was January 2009 to December 2010, and following analysis of the results and implementation of recommendations a re-audit was carried out on patients from July 2012 to December Results Original Audit Patients In the initial audit 226 patients (142 male, 84 female) were included with 269 Angioseals used in total. The average age was 69.7 years. 112 Angioseals were inserted on the right, 71 on the left and 43 bilaterally. Regarding the approach of the initial puncture, 205 were retrograde, 60 antegrade and 4 retrograde followed by antegrade (via turning of the sheath). Complications Angioseal failure: 10 (3.7%) - 3 were due to maldeployment, 2 due to bleeding around the Angioseal requiring manual compression and 1 due to heavy vascular calcification. Haematoma: 5 (1.9%) - one required a transfusion CFA occlusions: 4 (1.5%) - all required endarterectomies. 2 were noted to have a small calibre aorta. 1 patient had both occlusion and dissection. In one case the Angioseal maldeployed. CFA stenosis: 5 (1.9%) - 2 required surgery (one fem-pop bypass, one endarterectomy). 3 were asymptomatic. Angioseal embolus: 1 (0.4%) - failed deployment, followed by embolisation of the Angioseal to the popliteal artery trifurcation resulting in calf pain and requiring surgical embolectomy. No cases of retroperitoneal haematoma, pseudoaneurysm or infection. Page 6 of 10

7 Other Findings There was a higher complication rate in women (11.9% vs 7.7%). Eggebrecht et al (2004) also found a 7-fold increased risk of severe access complications in women, possibly due to smaller native vessels and a shorter CFA. However, the average age in our patient group was higher in women (75.9 vs 67.5 yrs), which may contribute to a higher complication rate. There was a slightly higher complication rate with antegrade vs retrograde approach (10% vs 7.3%) and with left-sided vs right-sided puncture (8.8% vs 7.1%). In 27% of cases the use of an Angioseal was not mentioned in the radiology report. This is important because if a significant complication does occur it is imperative that the clinical team are aware that an Angioseal device has been used. Recommendations The results showed that our department had higher Angioseal complication rates compared to the literature, mainly due to maldeployment and vascular occlusion/stenosis. Recommendations were made to reconsider the use of Angioseals in patients with small calibre arteries and to always make a note of Angioseal use in the final report. Re-Audit Patients The re-audit contained 198 patients (125 males, 73 females) with an average age of 67 yrs. 232 Angioseals were used, 107 on the right, 57 on the left, and 34 bilaterally. Regarding the approach, 191 were retrograde, 40 antegrade and 1 was antegrade followed by retrograde. Complications Angioseal failure: 4 (1.7%) CFA occlusion: 1 (0.4%) - In this case the Angioseal maldeployed and the leg became ischaemic following the procedure. At surgery, the Angioseal was found deployed within the CFA, occluding it. Haematoma: 8 (3.4%) - 7 minor, 1 moderate. Page 7 of 10

8 Pseudoaneurysm: 1 (0.4%) - this was associated with the moderate haematoma No cases of retroperitoneal haematoma or infection Other Findings Slightly higher complication rates with male vs female patients (6.4% vs 4.1%), retrograde vs antegrade approach (5.2% vs 2.5%) and right vs left side (6.4% vs 2.2%). However the overall number of complications was low, making it difficult to draw conclusions from this. Angioseals are being used more often in our department. In 11% of cases the Angioseal was not mentioned in the report. Comparison The comparison of the original audit, re-audit and literature complication rates are displayed in the table. Images for this section: Page 8 of 10

9 Table 1: Table showing original audit and re-audit complication rates compared to the meta-analysis and registry complication rates. Page 9 of 10

10 Conclusion Our Angioseal complication rates have improved significantly for serious complications such as vascular occlusion/stenosis and for maldeployment of the device. This is partly due to increased experience with using the device and partly due to better patient selection. The occurrance of local haematoma appears to have increased but this may be due to increased reporting of small haematomas. We now also meet the standards set by the literature in all categories except regarding haematomas. The inclusion of Angioseal use in the formal report of the interventional procedure has also improved, although ideally it should be mentioned in 100% of all reports so there is still room for improvement here. We will re-audit our Angioseal complication rates in another two years to ensure continual improvement in our practice. Personal information References Das R, Ahmed K, Athanasiou T, Morgan RA, Belli A-M (2011) 'Arterial Closure Devices Versus Manual Compression for Femoral Haemostasis in Interventional Radiological Procedures: A Systemic Review and Meta-Analysis', Cardiovascular and Interventional Radiology, 34(4): Reekers JA, Müller-Hülsbeck S, Libicher M, Atar E, Trentmann J, Goffette P, Borggrefe J, Zele#ák K, Hooijboer P, Belli A-M (2011) 'CIRSE Vascular Closure Device Registry', Cardiovascular and Interventional Radiology, 34(1):50-53 Eggebrecht H, von Birgelen C, Naber C, Kröger K, Schmermund A, Wieneke H, Bartel T, Wörtgen U, Baumgart D, Haude M, Erbel R (2004) 'Impact of Gender on Femoral Access Complications Secondary to Application of a Collagen-Based Vascular Closure Device', Journal of Invasive Cardiology, 16(5): Page 10 of 10