AMAZING THINGS ARE HAPPENING HERE Manual Compression Still

AMAZING THINGS ARE HAPPENING HERE Manual Compression: “Still the Gold Standard” Michael Guiry, RPA-C Chief Physician Assistant Interventional Cardiology New. York-Presbyterian The University Hospital of Columbia and Cornell

DISCLOSURES Michael Guiry, MD Honoraria – The Medicines Company

Are closure devices better than manual compression? AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Ideal Method for Hemostasis v 99% Reliable (with short time to hemostasis) v. Inexpensive v. Failure Mode Benign v. Easy Removal v. Absence of Complications v. Absence of Foreign Body/Infection v. Easy Reentry AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Indications for VCD’s Indications Angio. Seal Perclose Star. Close Diagnostic Cath + + + PCI + + + 5 F and 6 F + + + 7 F + + NM 8 F + + NM Ipsilateral Access less than 90 days 1 cm higher Not indicated No restriction Instructions for use: Angioseal VIP 2006, Perclose 2006, Star. Close 2007 AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Contra-indications for VCD’s: Warnings Do Not Use If Contra-indications Angio. Seal Perclose Star. Close SFA or Profunda Insertion + + + Bifurcation Insertion + + + Above Inguinal Lig. + + + Posterior Wall Puncture NM + + Multiple Punctures NM + + Instructions for use: Angioseal VIP 2006, Perclose 2006, Star. Close 2007 AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Arteriotomy Closure Devices Time to hemostasis Time to ambulation ? Complication rate AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Percutaneous Arterial Closure Devices 33, 125 patients in 21 trials DIAGNOSTIC PCI AMAZING THINGS ARE HAPPENING HERE §Diagnostic: hemostasis equivalent to compression, complications higher §PCI: efficacious as compression without correction of anticoagulation, complication rates similar New. York-Presbyterian The University Hospital of Columbia and Cornell §No individual device was superior Journal of Vascular & Interventional Radiology. 14(7): 865 -85, 2003

Surgical Complications from Closure Devices 100 Medical Device Reports on FDA Manufacturer and User Facility Device Experience Database for Vasoseal, Angio-Seal, and Perclose AMAZING THINGS ARE HAPPENING HERE American Journal of Surgery. 178(6): 511 -6, 1999 New. York-Presbyterian The University Hospital of Columbia and Cornell

Meta-Analysis of ACD’s Randomized Control Trials Cohort Studies Case-Control Studies • Closure Devices studied – Angioseal, Vasoseal, Perclose; • 82 eligible trials, only 30 trials met inclusion criteria; • 37, 066 patients; AMAZING THINGS ARE HAPPENING HERE From Nikolsky et al. JACC 2004; 44: 1200 -1209 New. York-Presbyterian The University Hospital of Columbia and Cornell

Studies Included Results All Included Studies 30 Angio. Seal Vaso. Seal Perclose 12 10 15 Dx PCI 2 8 2 6 3 13 AMAZING THINGS ARE HAPPENING HERE Dx+PCI 4 5 5 New. York-Presbyterian The University Hospital of Columbia and Cornell

Conclusions Ø In the setting of diagnostic cardiac catheterization, neither of studied closure devices offered statistical advantage in access site complication rate compared with mechanical compression Ø In the setting of PCI, Angio. Seal and Perclose did not provide benefit or harm in access site complication rate compared with mechanical compression. The rates of access site related complications were higher using Vaso. Seal compared with mechanical compression Ø Additional studies are required to examine the safety of ACDs and the impact of generational advances of these devices on patient outcomes. New. York-Presbyterian AMAZING THINGS ARE HAPPENING HERE The University Hospital of Columbia and Cornell

Vascular Closure Advantages AMAZING THINGS ARE HAPPENING HERE ØShorter Hemostasis ØShorter LOS for Ambi Patients ? ØPatient Comfort ? ØLess Staff Time ØImproved Experience New. York-Presbyterian The University Hospital of Columbia and Cornell

Vascular Closure Disadvantages §Cost §Reentry Into Site §Additive Complications: AMAZING THINGS ARE HAPPENING HERE §Infection from Foreign Body §Device Related Occlusion / Ischemia §Device Embolization New. York-Presbyterian The University Hospital of Columbia and Cornell

Why Should We Use Vascular Closure Devices Over Manual Compression? Resnic, 2001 Tavris, 2004 Vaitkus, 2004 Nikolsky, 2004 Arora, 2007 Koreny, 2004 Exaire, 2004 Applegate, 2006 Nikolsky, 2004 (Vaso. Seal) Applegate, 2008 Favors VCD Favors MC Adapted from Dauerman HL, Applegate R, Cohen DJ, J Am Coll Cardiol 2007 AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Clinical Trial Challenges • Varying definitions for ¡ Device success • Exclusion of complications • Exclusion of adjunctive compression ¡ Procedure success – all bleeding eventually stops ¡ Endpoints –particularly hematoma size • Varying follow-up duration – in-lab, 24 hours, in-hospital, 30 days AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Clinical Trial Challenges • Endpoints with guaranteed wins for devices versus manual compression ¡ Particularly time to ambulation • No randomized control trials • What about “real world” practice AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

“Gold Standard” Manual Pressure AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Manual Compression 5 F Diagnostic Ambulation N=260 Time To Ambulation 1. 8 -3. 1 hrs Surgical Complications 0% Kern, JACC 1990 AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Immediate Sheath Removal After 6 F Angioplasty Immediate (n=182) 4 Hours Later (n=79) P Value 54% NS Procedure Time (min) 40. 7 ± 25 62. 2 ± 43 < 0. 0001 Hemostasis Time (min) 13. 8 ± 7. 4 19. 7 ± 12 < 0. 0001 15% 30% < 0. 01 2. 2 ± 1. 9 2. 8 ± 1. 8 < 0. 02 Stent Deployed Hematoma > 3 cm Time to Discharge (days) D. Metz et al, J Invas Cardiol 1999 AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Vascular Complications Factors Increasing Risk for Hemostasis ¡ Elevated SBP (> 180 mm. HG) at time of sheath removal ¡ Aortic Insufficiency ¡ Low Body Weight ¡ Elderly Female ¡ Coagulopathies ¡ Intense anticoagulation, (i. e. fibrinolytics, Gp. IIb/IIIa antagonists) ¡ Large arterial sheath size ¡ Pre-existing peripheral vascular disease New. York-Presbyterian ¡ Renal Disease AMAZING THINGS ARE HAPPENING HERE The University Hospital of Columbia and Cornell

Sheath Removal Protocol AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Closure Device Protocol AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Femoral Sheath Protocol AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Femoral Artery Management: Breakdown Devices AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

How to Avoid Complications! AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Ideal Anatomic Vascular Access AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Access is Everything! Dissection AMAZING THINGS ARE HAPPENING HERE Embolization New. York-Presbyterian The University Hospital of Columbia and Cornell

Watch your PUNCTURE first C C B B A A D AMAZING THINGS ARE HAPPENING HERE D New. York-Presbyterian The University Hospital of Columbia and Cornell

Declining Vascular Complications rates in PCI P < 0. 001 for Temporal Trend Northern New England Cardiovascular Disease Study Group AMAZING THINGS ARE HAPPENING HERE JACC 2007 New. York-Presbyterian The University Hospital of Columbia and Cornell

Advantages/Disadvantages Radial Access AMAZING THINGS ARE HAPPENING HERE §Major Vascular Complications < 0. 1% §Better Access in Morbidly Obese Patient §Access Failure 3 -7% §Radial Occlusion occurs in 0 -24% of cases §Requires Special Catheter Shapes §Beware of Tortuosity Am Heart J 1999; 138: 430. Cathet Cardiovasc Diagn, 1996; 39: 365 -370. Mann, JACC 1998; 32: 572 -6. Kiemeniej, JACC 1997; 29: 1269 -75. Cooper, Am Heart J 1999; 138: 430 -6. New. York-Presbyterian The University Hospital of Columbia and Cornell

The Radial Advantage!! AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell

Final Thoughts: • Vascular Closure Devices (VCD) are unreliable, expensive and increase complications. • Before using a VCD, explain to the Patient and Family that use of the device will allow ambulation at 1 -hour, though they still won’t go home, AND for this “benefit” are at increased risk of groin complications- such as infection, device embolization or leg ischemia. OR • Offer, the gold standard in access management: AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian Manual Compression The University Hospital of Columbia and Cornell

GOOD LUCK! AMAZING THINGS ARE HAPPENING HERE New. York-Presbyterian The University Hospital of Columbia and Cornell