1. Manual Compression: “Still the Gold Standard”
Michael Guiry, RPA-C
Chief Physician Assistant
Interventional Cardiology

2. DISCLOSURES
Michael Guiry, MD
Honoraria
The Medicines Company

3. Are closure devices better than manual compression?

4. Ideal Method for Hemostasis
99% Reliable (with short time to hemostasis)
Inexpensive
Failure Mode Benign
Easy Removal
Absence of Complications
Absence of Foreign Body/Infection
Easy Reentry

5. Indications for VCD’s Indications AngioSeal Perclose StarClose
Diagnostic Cath +
PCI
5F and 6F 7F NM 8F
Ipsilateral Access less than 90 days
1cm higher
No restriction
Not indicated
Instructions for use: Angioseal VIP 2006, Perclose 2006, StarClose 2007

6. Contra-indications for VCD’s: Warnings Do Not Use If -
AngioSeal
Perclose
StarClose
SFA or Profunda Insertion +
Bifurcation Insertion
Above Inguinal Lig.
Posterior Wall Puncture NM
Multiple Punctures
Instructions for use: Angioseal VIP 2006, Perclose 2006, StarClose 2007

7. Arteriotomy Closure Devices
Time to hemostasis
Time to ambulation
Arteriotomy closure devices are an alternative to traditional mechanical mode of hemostasis after percutaneous endovascular procedures.
These devices have been demonstrated to reduce the time to hemostasis, facilitate patient mobilization and decrease hospital length of stay.
However, clinical utility of ACD in terms of access site complications is controversial.
? Complication rate

8. Percutaneous Arterial Closure Devices 33,125 patients in 21 trials
DIAGNOSTIC
PCI
Meta-analysis of published trials have shown variable resluts
Hoffer EK. Bloch RD. Percutaneous arterial closure devices.Journal of Vascular & Interventional Radiology. 14(7):865-85, 2003
Advances in interventional angiography such as covered stent technology and adjunctive anticoagulation and antiplatelet therapy for arterial recanalization have reached the margins of percutaneous application. In these circumstances, compression methods of arterial closure require prolonged compression or long arterial sheath dwell times that increase procedural time, complication rates, and patient discomfort. Percutaneous arterial closure devices offer the potential of rapid hemostasis and shorter times to ambulation and discharge. These benefits have costs, in terms of the price of the devices and complications of their use. A Web search identified approved and pending devices. A Medline search identified device studies that were reviewed to assess the efficacy and complication rates of device-mediated closure versus the gold standard of manual compression. Studies that compared devices were evaluated to determine if any particular device was superior. The arterial closure devices were equivalent to manual compression in the establishment of hemostasis in the diagnostic population. However, complication rates were higher. In the therapeutic populations, the devices were as efficacious as manual compression, without correction of anticoagulation, and the complication rates were similar. No individual device was clearly superior.
Diagnostic: hemostasis equivalent to compression, complications higher
PCI: efficacious as compression without correction of anticoagulation, complication rates similar
No individual device was superior
Journal of Vascular & Interventional Radiology. 14(7):865-85, 2003

9. Surgical Complications from Closure Devices
Eidt JF. Habibipour S. Saucedo JF. McKee J. Southern F. Barone GW. Talley JD. Moursi M. Surgical complications from hemostatic puncture closure devices. American Journal of Surgery. 178(6):511-6, 1999
For securing immediate hemostasis following percutaneous arterial catheterization, the Food and Drug Administration has approved three hemostatic puncture closure devices. We reviewed our institutional experience with one device (Angio-Seal).
METHODS: A retrospective, single-center, nonrandomized observational study was made of all vascular complications following femoral cardiac catheterization.
RESULTS: An immediate mechanical failure of the device was experienced in 34 (8%) patients. Surgical repair was required in 1.6% (7 of 425) of patients following Angio-Seal versus 0.3% (5 of 1662) following routine manual compression (P = 0.004). In 5 patients, the device caused either complete occlusion or stenosis of the femoral artery. The polymer anchor embolized in 1 patient and was retrieved with a balloon catheter at surgery.
CONCLUSION: During the first year of utilization of a percutaneous hemostatic closure device following cardiac catheterization, we observed a marked increase in arterial occlusive complications requiring surgical repair. Surgeons must be familiar with the design of these devices to achieve precise repair of surgical complications.
100 Medical Device Reports on FDA Manufacturer and User Facility Device Experience Database for Vasoseal, Angio-Seal, and Perclose
American Journal of Surgery. 178(6):511-6, 1999

10. 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;
From Nikolsky et al. JACC 2004;44:

11. Studies Included All Included Studies AngioSeal VasoSeal Perclose
Results
All Included Studies 30
AngioSeal
VasoSeal
Perclose 12 10 15 Dx
PCI Dx
PCI Dx
PCI 2 8 2 6 3 13
Dx+PCI
Dx+PCI
Dx+PCI 4 5 5

12. Conclusions
In the setting of diagnostic cardiac catheterization, neither of studied closure devices offered statistical advantage in access site complication rate compared with mechanical compression
In the setting of PCI, AngioSeal 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 VasoSeal compared with mechanical compression
Additional studies are required to examine the safety of ACDs and the impact of generational advances of these devices on patient outcomes.

13. Advantages Vascular Closure Shorter Hemostasis
Shorter LOS for Ambi Patients ?
Patient Comfort ?
Less Staff Time
Improved Experience
Vascular Closure

14. Disadvantages Vascular Closure Cost Reentry Into Site
Additive Complications:
Infection from Foreign Body
Device Related Occlusion / Ischemia
Device Embolization
          
                                
Vascular Closure

15. Why Should We Use Vascular Closure Devices Over Manual Compression?
Resnic, 2001
Tavris,2004
Vaitkus, 2004
Nikolsky, 2004
Arora, 2007
Nikolsky, 2004 (VasoSeal)
Applegate, 2008
Exaire, 2004
Koreny, 2004
Applegate, 2006
Favors VCD
Favors MC
Adapted from Dauerman HL, Applegate R, Cohen DJ, J Am Coll Cardiol 2007

16. 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

17. 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

18. “Gold Standard”
Manual Pressure

19. Surgical Complications
5F Diagnostic Ambulation
N=260
Time To Ambulation
hrs
Surgical Complications 0%
          
                                
Manual Compression
Kern, JACC 1990

20. Immediate Sheath Removal After 6F Angioplasty
4 Hours Later
(n=79) P
Value
Stent Deployed
54% NS
Procedure Time (min)
40.7 ± 25
62.2 ± 43
<
Hemostasis Time (min)
13.8 ± 7.4
19.7 ± 12
Hematoma > 3 cm
15%
30%
< 0.01
Time to Discharge (days)
2.2 ± 1.9
2.8 ± 1.8
< 0.02
D.Metz et al, J Invas Cardiol 1999

21. Vascular Complications
Factors Increasing Risk for Hemostasis
Elevated SBP (> 180mmHG) at time of sheath removal
Aortic Insufficiency
Low Body Weight
Elderly Female
Coagulopathies
Intense anticoagulation, (i.e. fibrinolytics, GpIIb/IIIa antagonists)
Large arterial sheath size
Pre-existing peripheral vascular disease
Renal Disease

22. Sheath Removal Protocol
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23. Closure Device Protocol
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24. Femoral Sheath Protocol
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26. Femoral Artery Management: Breakdown
Devices
Worldwide market 495 million, Angioseal 72%, Perclose 23, Vasoseal 4%, ? Duett, patches
My data is not precise (an understatement), but my estimates for the 2005 U.S. sealing device market are as follows:
Radial = 10%
Manual compression = 50%
Patches = 10%  (broken down by Syvek 25%, D-Stat Dry 20%, Chito-Seal 20%, Clo-Sur P.A.D. 10%, Neptune 10%, Stasys 10%, Others 5%)
Invasive Sealing Devices = 30% (broken down by Angio-Seal 85%, Perclose 10%, VasoSeal 4%, Duett 1%)
Attached are a couple of slides with additional information if useful.  See you in Rome later this week and dinner on Thursday.
Howard

27. How to Avoid Complications!

28. Ideal Anatomic Vascular Access

29. Access is Everything!
Dissection
Embolization

30. Watch your PUNCTURE firstD B C A D B C
Routine femoral angiography at the end of the catheterization procedure is a significant advance.[42-44] Such angiography allows identification of the major risk factor for retroperitoneal hemorrhage-sheath insertion above the inferior epigastric artery.[44-46] In addition, femoral angiography identifies the estimated 13% of patients with nonfemoral artery sheath insertion for which VCD utilization is of unclear efficacy (Fig. 4).[20,43] Identification of significant femoral arterial disease may allow selective use of manual compression in situations where implantation of an intravascular device may be associated with an increased risk of complications ( Table 1 ).[7,47] Furthermore, femoral angiography may be especially important in the setting of multiple procedures at the same femoral access site; there is limited data regarding the safety of repeat access, and further study regarding the pathological and potential anatomical effects of repeat access with different devices is warranted.[48-50]

31. Declining Vascular Complications rates in PCI
P < for Temporal Trend
Northern New England Cardiovascular Disease Study Group
JACC 2007

32. Advantages/Disadvantages
Radial Access
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
Advantages/Disadvantages
Mann, JACC 1998;32:572-6.
Kiemeniej, JACC 1997;29:
Cooper, Am Heart J 1999;138:430-6.
Am Heart J 1999;138:430.
Cathet Cardiovasc Diagn,1996;39:

33. The Radial Advantage!!

34. 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:
Manual Compression

35. GOOD
LUCK!