Top

European Radiology

Published in:

01-07-2016 | Vascular-Interventional

Safety and efficiency of femoral artery access closure with a novel biodegradable closure device: a prospective single-centre pilot study

Authors: Karla M. Treitl, Alma Ali, Marcus Treitl

Published in: European Radiology | Issue 7/2016

Abstract

Objectives

Vascular closure devices can accelerate haemostasis after arteriotomy, but induce scarring. The aim of the study was to prospectively analyse the feasibility of a novel biodegradable arterial closure device (CD).

Methods

Two hundred fifty-five patients (183 male; age 36–98 years) with an access vessel diameter >3 mm received the biodegradable CD after endovascular therapy. Technical success rate, time-to-haemostasis (TTH) and time-to-ambulation (TTA) were measured. Puncture site complications were categorized as minor (local hematoma, minor bleeding) or major (pseudoaneurysm, embolization, dissection, thrombotic occlusion, hematoma/major bleeding requiring surgery, access site infection).

Results

Technical success was achieved in 98.8 % (252 cases); device failure occurred in three cases (1.2 %). The average TTH and TTA were 11.3 ± 26.9 s and 73.0 ± 126.3 min. The major complication rate was 1.6 %, with three pseudoaneurysms and one retroperitoneal bleeding. The minor complication rate was 2.0 %, with five small hematomas. Neither cardiovascular risk factors nor access vessel characteristics had statistically significant influence on adverse events. Re-puncture was uncomplicated in 32 cases after 155.0 ± 128.8 days.

Conclusions

Handling of the new biodegradable CD is safe. The complication rates are tolerably low and comparable to other CDs. Post-procedural sonography showed no significant palpable subcutaneous changes in the access site.

Key Points

• VCDs can increase time efficiency and patient comfort after intervention.

• In this prospective single-centre-study, biodegradable CD was safe and easily applicable.

• Its major and minor complication rates are comparable to other CDs.

• Its mean time-to-haemostasis and time-to-ambulation were 11.3 ± 26.9 s and 73.0 ± 126.3 min.

• Post-procedural sonography showed no significant palpable subcutaneous changes at the access site.

Patel MR, Jneid H, Derdeyn CP et al (2010) Arteriotomy closure devices for cardiovascular procedures: a scientific statement from the American Heart Association. Circulation 122:1882–1893CrossRefPubMed

Sheth RA, Walker TG, Saad WE et al (2014) Quality improvement guidelines for vascular access and closure device use. J Vasc Interv Radiol 25:73–84CrossRefPubMed

Hon LQ, Ganeshan A, Thomas SM, Warakaulle D, Jagdish J, Uberoi R (2010) An overview of vascular closure devices: what every radiologist should know. Eur J Radiol 73:181–190CrossRefPubMed

Treitl M, Eberhardt KM, Maxien D, Behrends B, Reiser MF (2013) Arterial closure devices. What device for which clinical situation? Radiologe 53:230–245CrossRefPubMed

Schulz-Schupke S, Helde S, Gewalt S et al (2014) Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical trial. JAMA 312:1981–1987CrossRefPubMed

Nelson PR, Kracjer Z, Kansal N et al (2014) A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). J Vasc Surg 59:1181–1193CrossRefPubMed

Chevalier B, Lancelin B, Koning R et al (2003) Effect of a closure device on complication rates in high-local-risk patients: results of a randomized multicenter trial. Catheter Cardiovasc Interv 58:285–291CrossRefPubMed

Gargiulo NJ 3rd, Veith FJ, Ohki T et al (2007) Histologic and duplex comparison of the Perclose and Angio-Seal percutaneous closure devices. Vascular 15:24–29CrossRefPubMed

Zhu J, Clark RA (2014) Fibronectin at select sites binds multiple growth factors and enhances their activity: expansion of the collaborative ECM-GF paradigm. J Investig Dermatol 134:895–901CrossRefPubMed

10.

Huppert P, Tacke J, Lawall H, Deutschen Gesellschaft fur AG (2010) S3 guidelines for diagnostics and treatment of peripheral arterial occlusive disease. Radiologe 50:7–15CrossRefPubMed

11.

Koreny M, Riedmuller E, Nikfardjam M, Siostrzonek P, Mullner M (2004) Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA 291:350–357CrossRefPubMed

12.

Popma JJ, Satler LF, Pichard AD et al (1993) Vascular complications after balloon and new device angioplasty. Circulation 88:1569–1578CrossRefPubMed

13.

Lewis-Carey MB, Kee ST (2003) Complications of arterial closure devices. Tech Vasc Interv Radiol 6:103–106CrossRefPubMed

14.

Das R, Ahmed K, Athanasiou T, Morgan RA, Belli AM (2011) Arterial closure devices versus manual compression for femoral haemostasis in interventional radiological procedures: a systematic review and meta-analysis. Cardiovasc Intervent Radiol 34:723–738CrossRefPubMed

15.

Reekers JA, Muller-Hulsbeck S, Libicher M et al (2011) CIRSE vascular closure device registry. Cardiovasc Intervent Radiol 34:50–53CrossRefPubMed

16.

Biancari F, D'Andrea V, Di Marco C, Savino G, Tiozzo V, Catania A (2010) Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J 159:518–531CrossRefPubMed

Title: Safety and efficiency of femoral artery access closure with a novel biodegradable closure device: a prospective single-centre pilot study
Authors: Karla M. Treitl
Alma Ali
Marcus Treitl
Publication date: 01-07-2016
Publisher: Springer Berlin Heidelberg
Published in: European Radiology / Issue 7/2016
Print ISSN: 0938-7994
Electronic ISSN: 1432-1084
DOI: https://doi.org/10.1007/s00330-015-4023-6

At a glance: The STEP trials

Springer Medicine

Safety and efficiency of femoral artery access closure with a novel biodegradable closure device: a prospective single-centre pilot study

Abstract

Objectives

Methods

Results

Conclusions

Key Points

At a glance: The STEP trials

Springer Medicine

Abstract

Objectives

Methods

Results

Conclusions

Key Points

Please log in to get access to this content

Other articles of this Issue 7/2016

Multimodality imaging assessment of the deleterious role of the intraluminal thrombus on the growth of abdominal aortic aneurysm in a rat model

IVIM DW-MRI of autoimmune pancreatitis: therapy monitoring and differentiation from pancreatic cancer

Is there a systematic bias of apparent diffusion coefficient (ADC) measurements of the breast if measured on different workstations? An inter- and intra-reader agreement study

Potential of MR histogram analyses for prediction of response to chemotherapy in patients with colorectal hepatic metastases

Computer-aided detection of pulmonary nodules: a comparative study using the public LIDC/IDRI database

Comparison of the image qualities of filtered back-projection, adaptive statistical iterative reconstruction, and model-based iterative reconstruction for CT venography at 80 kVp