Vol 26, No 3 (2019)
Original articles — Interventional cardiology
Published online: 2018-03-29

open access

Page views 5621
Article views/downloads 1405
Get Citation

Connect on Social Media

Connect on Social Media

Thermic sealing in femoral catheterization: First experience with the Secure Device

Michael Sacherer1, Ewald Kolesnik1, Friederike von Lewinski1, Nicolas Verheyen1, Karin Brandner1, Markus Wallner12, Deborah M. Eaton2, Olev Luha1, Robert Zweiker1, Dirk von Lewinski1
Pubmed: 29611164
Cardiol J 2019;26(3):233-240.

Abstract

Background: Devices currently used to achieve hemostasis of the femoral artery following percutaneous cardiac catheterization are associated with vascular complications and remnants of artificial materials are retained at the puncture site. The Secure arterial closure Device induces hemostasis by utilizing thermal energy, which causes collagen shrinking and swelling. In comparison to established devices, it has the advantage of leaving no foreign material in the body following closing. This study was designed to evaluate the efficacy and safety of the Secure Device to close the puncture site following percutaneous cardiac catheterization.

Methods: The Secure Device was evaluated in a prospective non-randomized single-center trial with patients undergoing 6 F invasive cardiac procedures. A total of 67 patients were enrolled and the device was utilized in 63 patients. Fifty diagnostic and 13 interventional cases were evaluated. Femoral artery puncture closure was performed immediately after completion of the procedure. Time to hemostasis (TTH), time to ambulation (TTA) and data regarding short-term and 30-day clinical follow-up were recorded.

Results: Mean TTH was 4:30 ± 2:15 min in the overall observational group. A subpopulation of patients receiving anticoagulants had a TTH of 4:53 ± 1:43 min. There were two access site complications (hematoma > 5 cm). No major adverse events were identified during hospitalization or at the 30 day follow-up.

Conclusions: The new Secure Device demonstrates that it is feasible in diagnostic and interventional cardiac catheterization. With respect to safety, the Secure Device was non-inferior to other closure devices as tested in the ISAR closure trial.

Article available in PDF format

View PDF Download PDF file

References

  1. Walter J, Vogl M, Holderried M, et al. Manual Compression versus Vascular Closing Device for Closing Access Puncture Site in Femoral Left-Heart Catheterization and Percutaneous Coronary Interventions: A Retrospective Cross-Sectional Comparison of Costs and Effects in Inpatient Care. Value Health. 2017; 20(6): 769–776.
  2. Hon LQ, Ganeshan A, Thomas SM, et al. An overview of vascular closure devices: what every radiologist should know. Eur J Radiol. 2010; 73(1): 181–190.
  3. Krishnasamy VP, Hagar MJ, Scher DJ, et al. Vascular closure devices: technical tips, complications, and management. Tech Vasc Interv Radiol. 2015; 18(2): 100–112.
  4. Davidson LJ, Luna J, Virmani R, et al. First human experience of thermal arterial closure. Catheter Cardiovasc Interv. 2014; 84(1): 30–36.
  5. Schulz-Schüpke S, Helde S, Gewalt S, et al. Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical trial. JAMA. 2014; 312(19): 1981–1987.
  6. Holm NR, Sindberg B, Schou M, et al. Randomised comparison of manual compression and FemoSeal™ vascular closure device for closure after femoral artery access coronary angiography: the CLOSure dEvices Used in everyday Practice (CLOSE-UP) study. EuroIntervention. 2014; 10(2): 183–190.
  7. Koreny M, Riedmüller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA. 2004; 291(3): 350–357.
  8. Nikolsky E, Mehran R, Halkin A, et al. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis. J Am Coll Cardiol. 2004; 44(6): 1200–1209.
  9. Martin JL, Pratsos A, Magargee E, et al. A randomized trial comparing compression, Perclose Proglide and Angio-Seal VIP for arterial closure following percutaneous coronary intervention: the CAP trial. Catheter Cardiovasc Interv. 2008; 71(1): 1–5.
  10. Dong H, Peng M, Jiang X, et al. Endovascular therapy for Angio-seal-related acute limb ischemia: Perioperative and long-term results. Catheter Cardiovasc Interv. 2017; 89(S1): 609–615.
  11. Gargiulo NJ, Veith FJ, Ohki T, et al. Histologic and duplex comparison of the perclose and angio-seal percutaneous closure devices. Vascular. 2007; 15(1): 24–29.
  12. Kabelitz L, Nonn A, Nolte KW, et al. Long term outcome after application of the angio-seal vascular closure device in minipigs. PLoS One. 2016; 11(9): e0163878.
  13. Spiliopoulos S, Katsanos K, Karnabatidis D, et al. Safety and efficacy of the StarClose vascular closure device in more than 1000 consecutive peripheral angioplasty procedures. J Endovasc Ther. 2011; 18(3): 435–443.
  14. Minko P, Katoh M, Gräber S, et al. Obesity: an independent risk factor for insufficient hemostasis using the AngioSeal vascular closure device after antegrade puncture. Cardiovasc Intervent Radiol. 2012; 35(4): 775–778.
  15. Schmelter C, Liebl A, Poullos N, et al. Suitability of Exoseal vascular closure device for antegrade femoral artery puncture site closure. Cardiovasc Intervent Radiol. 2013; 36(3): 659–668.