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

DISCLOSURES Michael Guiry, MD Honoraria The Medicines Company

Are closure devices better than manual compression?

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

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

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

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

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

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

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;44:1200-1209

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

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.

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

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

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

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

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

“Gold Standard” Manual Pressure

Surgical Complications 5F Diagnostic Ambulation N=260 Time To Ambulation 1.8-3.1 hrs Surgical Complications 0%                                             Manual Compression Kern, JACC 1990

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 < 0.0001 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

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

Sheath Removal Protocol This is the Bulleted List slide. To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left) The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide. If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page. Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows: Choose View / Master / Slide Master from your menu. Select the text at the bottom of the slide and type in a short version of your presentation title. Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle)

Closure Device Protocol This is the Bulleted List slide. To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left) The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide. If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page. Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows: Choose View / Master / Slide Master from your menu. Select the text at the bottom of the slide and type in a short version of your presentation title. Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle)

Femoral Sheath Protocol This is the Bulleted List slide. To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left) The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide. If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page. Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows: Choose View / Master / Slide Master from your menu. Select the text at the bottom of the slide and type in a short version of your presentation title. Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle)

This is the Bulleted List slide. To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left) The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide. If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page. Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows: Choose View / Master / Slide Master from your menu. Select the text at the bottom of the slide and type in a short version of your presentation title. Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle)

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

How to Avoid Complications!

Ideal Anatomic Vascular Access

Access is Everything! Dissection Embolization

Watch your PUNCTURE first D 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]

Declining Vascular Complications rates in PCI P < 0.001 for Temporal Trend Northern New England Cardiovascular Disease Study Group JACC 2007

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;29:1269-75. Cooper, Am Heart J 1999;138:430-6. Am Heart J 1999;138:430. Cathet Cardiovasc Diagn,1996;39:365-370.

The Radial Advantage!!

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

GOOD LUCK!