Journal of Korean Neurosurgical Society

The Korean Neurosurgical Society (대한신경외과학회)
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Angio-$Seal^{TM}$ $Evolution^{TM}$ versus Manual Compression for Common Femoral Artery Puncture in Neurovascular Diagnostic Angiography: A Prospective, Non-Randomized Study

  • Chung, Joon-Ho (Department of Neurosurgery, Inha University School of Medicine) ;
  • Lee, Dong-Woo (Department of Neurosurgery, Cheju Halla General Hospital) ;
  • Kwon, Ok-Sim (Department of Neurosurgery, Seoul St. Mary's Hospital, The Catholic University of Korea) ;
  • Kim, Bum-Soo (Department of Radiology, Seoul St. Mary's Hospital, The Catholic University of Korea) ;
  • Shin, Yong-Sam (Department of Neurosurgery, Seoul St. Mary's Hospital, The Catholic University of Korea)
  • Received : 2010.11.12
  • Accepted : 2011.03.03
  • Published : 2011.03.28
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Abstract

Objective : This prospective, non-randomized study compared the safety and efficacy of the Angio-$Seal^{TM}$ $Evolution^{TM}$ to that of manual compression for common femoral artery punctures in neurovascular diagnostic angiography. Methods : From June 2009 to September 2009, we performed 169 diagnostic trans-femoral cerebral angiographies, using either the Angio-$Seal^{TM}$ $Evolution^{TM}$ or manual compression to achieve hemostasis. We included 60 patients in this study, 30 in each group. We defined minor complications as those requiring no further treatment such as hematoma size less than 6 cm and bruise size less than 25 cm. Major complications were those requiring surgery of the femoral artery pseudoaneurysm and/or the second line increase of hospital stay even without further treatment. Results : Mean time to hemostasis was $0.42{\pm}0.04$ minutes for the angioseal and $15.83{\pm}1.63$ minutes for manual compression (p<0.001). Overall complication rate did not differ between the 2 groups. After the patients were fully mobile, at 24 hours, the rate of onset of new complication differed significantly between the 2 groups (p=0.032). In the angioseal group, 5 (16.7%) of the 30 patients experienced the onset of a new complication after 24 hours, including 3 (60.0%) of the 5 who experienced major complications. Conclusion : The Angio-$Seal^{TM}$ $Evolution^{TM}$ is effective at decreasing mean time to hemostasis, like other closing devices. However, it may not be effective at producing early ambulation and discharge, compared to manual compression, because delayed complications may occur significantly after 24 hours.

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References

  1. Boztosun B, Gunes Y, Yildiz A, Bulut M, Saglam M, Kargin R, et al. : Early ambulation after diagnostic heart catheterization. Angiology 58 : 743-746, 2008 https://doi.org/10.1177/0003319707308890
  2. Doyle BJ, Konz BA, Lennon RJ, Bresnahan JF, Rihal CS, Ting HH : Ambulation 1 hour after diagnostic cardiac catheterization : a prospective study of 1009 procedures. Mayo Clin Proc 81 : 1537-1540, 2006 https://doi.org/10.4065/81.12.1537
  3. Eidt JF, Habibipour S, Saucedo JF, McKee J, Southern F, Barone GW, et al. : Surgical complications from hemostatic puncture closure devices. Am J Surg 178 : 511-516, 1999 https://doi.org/10.1016/S0002-9610(99)00246-9
  4. Hermiller J, Simonton C, Hinohara T, Lee D, Cannon L, Mooney M, et al. : Clinical experience with a circumferential clip-based vascular closure device in diagnostic catheterization. J Invasive Cardiol 17 : 504-510, 2005
  5. Hoffer EK, Bloch RD : Percutaneous arterial closure devices. J Vasc Interv Radiol 14 : 865-885, 2003 https://doi.org/10.1097/01.RVI.0000071086.76348.8E
  6. Koreny M, Riedmuller E, Nikfardjam M, Siostrzonek P, Mullner M : Arterial puncture closing devices compared with standard manual compression after cardiac catheterization : systematic review and meta-analysis. JAMA 291 : 350-357, 2004 https://doi.org/10.1001/jama.291.3.350
  7. Leoni CJ, Potter JE, Rosen MP, Brophy DP, Lang EV : Classifying complications of interventional procedures : a survey of practicing radiologists. J Vasc Interv Radiol 12 : 55-59, 2001 https://doi.org/10.1016/S1051-0443(07)61403-1
  8. Lewis-Carey MB, Kee ST : Complications of arterial closure devices. Tech Vasc Interv Radiol 6 : 103-106, 2003 https://doi.org/10.1053/tvir.2003.36444
  9. Macdonald S, Thomas SM, Cleveland TJ, Gaines PA : Outpatient vascular intervention : a two-year experience. Cardiovasc Intervent Radiol 25 : 403-412, 2002 https://doi.org/10.1007/s00270-002-1920-2
  10. Nasser TK, Mohler ER 3rd, Wilensky RL, Hathaway DR : Peripheral vascular complications following coronary interventional procedures. Clin Cardiol 18 : 609-614, 1995 https://doi.org/10.1002/clc.4960181105
  11. Popma JJ, Satler LF, Pichard AD, Kent KM, Campbell A, Chuang YC, et al. : Vascular complications after balloon and new device angioplasty. Circulation 88 : 1569-1578, 1993 https://doi.org/10.1161/01.CIR.88.4.1569
  12. Ratnam LA, Raja J, Munneke GJ, Morgan RA, Belli AM : Prospective nonrandomized trial of manual compression and Angio-Seal and Starclose arterial closure devices in common femoral punctures. Cardiovasc Intervent Radiol 30 : 182-188, 2007 https://doi.org/10.1007/s00270-006-0226-1
  13. Sacks D, Marinelli DL, Martin LG, Spies JB : Reporting standards for clinical evaluation of new peripheral arterial revascularization devices. Technology Assessment Committee. J Vasc Interv Radiol 8 : 137-149, 1997 https://doi.org/10.1016/S1051-0443(97)70530-X
  14. Upponi SS, Ganeshan AG, Warakaulle DR, Phillips-Hughes J, Boardman P, Uberoi R : Angioseal versus manual compression for haemostasis following peripheral vascular diagnostic and interventional procedures - a randomized controlled trial. Eur J Radiol 61 : 332-334, 2007 https://doi.org/10.1016/j.ejrad.2006.09.007
  15. Veasey RA, Large JK, Silberbauer J, Paul G, Taggu W, Ellery S, et al. : A randomized controlled trial comparing StarClose and AngioSeal vascular closure devices in a district general hospital - the SCOAST study. Int J Clin Pract 62 : 912-918, 2008 https://doi.org/10.1111/j.1742-1241.2008.01761.x
  16. Wagenbach A, Saladino A, Daugherty WP, Cloft HJ, Kallmes DF, Lanzino G : Safety of early ambulation after diagnostic and therapeutic neuroendovascular procedures without use of closure devices. Neurosurgery 66 : 493-496; discussion 496-497, 2010 https://doi.org/10.1227/01.NEU.0000359532.92930.07

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