Vascular Closure Devices Plugs Zoltan G Turi M

Vascular Closure Devices: Plugs Zoltan G. Turi, M. D. Professor of Medicine Cooper Medical School of Rowan University

Zoltan G. Turi, MD Consulting: Cordis Corporation Grant Support: Abbott Vascular Arstasis, Inc. St. Jude Medical, Inc. Marine Polymer Technologies, Inc.

Categories of closure devices • • Anchored plugs Unanchored plugs Suture closure Clip/staple closure Topical patches “No footprint” devices Closure begins with access

Unanchored Plugs • Passive approximation Vasoseal Duett Thrombosing agent

Nikolsky et al. JACC 2004.

Complication Rates OR (95% CI) Heterogeneity test P-value Dx studies 1. 44 [0. 43, 4. 82]† 0. 66 [0. 18/, 2. 38]* 0. 0003 0. 16 PCI studies 1. 11 [0. 94, 1. 33]* 1. 35 [0. 87, 2. 11]* 0. 22 0. 15 Both Dx+PCI studies 1. 83[1. 15, 2. 90]† 1. 15 [0. 67, 1. 98]* 0. 001 0. 43 All studies 1. 34 [1. 01, 1. 79]† 1. 30 [0. 90, 1. 87]* <0. 0001 0. 19 0. 1 0. 2 0. 5 1. 0 2. 0 5. 0 10. 0 Favors VCD Favors Manual Compression If Vaso. Seal was excluded, no difference Nikolsky et al. JACC 2004.

Change in Practice Vaso. Seal Angio-Seal Perclose Carey – CCI 2001 Duett

Cause of Death

Unanchored Plugs 1994 -2006 Vaso. Seal and Duett no longer marketed

End of the Unanchored Plugs ? • Passive approximation Mynx - Exo. Seal Through procedure sheath, simplified, resorption Passive approximation • Sealing agent

Vascade • Passive approximation • Thrombosing agent

Anchored Plugs Active Approximation Angio-Seal - Thrombosing agent High success rate, short learning curve, short deployment time Vascular occlusion, infection

Device Success VCD Device Closure Success - Interventions Most everything “works” in diagnostic cases Procedure success always looks good

From: Vascular Closure Device Failure in Contemporary Practice J Am Coll Cardiol Intv. 2012; 5(8): 837 -844. doi: 10. 1016/j. jcin. 2012. 05. 005

FISH Femoral Introducer Sheath and Hemostasis Small Intestinal Submucosa

Which Device to Use? • Patient and vessel specific: ¡ Fully anticoagulated • Active approximation ? ¡ Diseased vessel • Passive approximation ? • No intraluminal foreign body ¡ Oozing • Thrombosing or sealing agent, patch • Perhaps more important than above: ¡ Operator competence

Learning Curve Angio-Seal 14 % Warren CCI 1999 3. 5 % 8 F, post heparin, BMI

Where I think twice • Diabetes, immune suppressed, poor hygiene • • Too thin, too fat < 5 F Low stick, high stick Significant vascular disease

Infections • 0. 3% • Median incubation – 8 days • • • Staph aureus 75% BC + 86% Diabetics 80% PSA 42% 6 % mortality Sohail Mayo Clinic Proceedings Courtesy Dr. John Eidt, UAMS.

Factors Associated with RPH Ellis CCI 2006

High stick • 18: 1 ratio for RPH • Closure device in place – some space between plug and arterial wall

The Evidence Base • Complication rate manual compression = vascular closure device • Strong patient preference • Cost savings with shorter length of stay and less management outside cath lab