Most Common Surgical Procedures

Surgery Description Areas of Application/RationaleAortotomy for valve repair/replacement Incision made into the aorta to access damaged heart valves for replacement with animal or synthetic

valves. Aortotomy suture-line sealing; cardiac operative site coverage to prevent adhesion formation.

Aortic aneurysm/root repair Repair of defects in the aorta, the major arterial vessel exiting the heart. Includes ascending, descending, and total arch repair

Anastomotic suture-line sealing for hemostasis; cardiac operative site coverage to prevent adhesion formation.

Coronary artery bypass grafting (CABG) CABG involves using a segment of a vein or artery to bypass blocked coronary arteries. May be alone or combined with additional cardiac surgical procedures.

Anastomotic and cannulation suture-line sealing for hemostasis; cardiac operative site coverage to prevent adhesion formation.

Left ventricular assist device (LVAD) implantation Following removal of a failing heart, a left ventricular assist device is implanted into a patient until a replacement heart becomes available.

Anastomotic suture-line sealing for hemostasis; cardiac operative site coverage to prevent adhesion formation.

Staged congenital heart procedures Staged procedures to correct birth defects occurring in the heart, valves, or arteries. Anastomotic suture-line sealing for hemostasis; cardiac operative site coverage to prevent adhesion formation.

COSEAL SURGICAL SEALANT IS INDICATED FOR SEALING SUTURE LINES ALONG ARTERIAL AND VENOUS RECONSTRUCTIONS AND FOR PATIENTS UNDERGOING CARDIAC SURGERY TO PREVENT OR REDUCE THE INCIDENCE, SEVERITY, AND EXTENT OF POST SURGICAL ADHESION FORMATION.

smooth muscle cells

Cardiac Surgery Primer

Cross-section of Heart

Aortotomy

Aortic Aneurysm

Aortic Aneurysm/Root Repair

Aortic Vascular Anatomy

CABG Anastomoses

FOR INTERNAL USE ONLY

Vena Cava

Venous bypass

Coronary artery

Graft repair of aneurysm

Aorta

Suture line with COSEAL

Left subclavian

artery

Artery bypass

Ascending aorta

Coronary artery

Coronary artery

Image from A.D.A.M. Available at www.lab.anhb.uwa.edu.auAvailable at www.massgeneral.org/heartcenter

Application Benefits of Using COSEAL Surgical Sealant in Cardiac SurgeryAnastomotic Suture Line Sealing 1. COSEAL is a strong, flexible, and completely synthetic sealant ideal for cardiac surgery.1-3

2. COSEAL has been clinically proven to adhere to Dacron/ePTFE grafts as well as tissue,1,4,5 so it is well-suited to many reconstructive cardiac procedures, especially in the aorta.

Cardiac Adhesion Prevention Postoperative adhesion formation makes repeat cardiac surgery more challenging.6 Reduction in the severity of adhesions provides faster access to cardiothoracic structures.6 COSEAL has been clinically proven to reduce the severity of postoperative cardiac adhesions.6 No other surgical sealant has been clinically proven to deliver both sealing and adhesion prevention efficacy.

Tunica adventitia

Tunica mediaexternal elastic lamina

connective tissue

endothelium

internal elastic lamina

Tunica intima

Ascending aortic aneurysm

Aortic arch

Normal aortic root

Vena Cava

Aortotomy with

COSEAL

Aortic valve replacement

Ascending aorta

ObjectionsCOSEAL can’t be used with a cell saver. The use of COSEAL with a cell saver is not contraindicated. COSEAL is completely synthetic and does not possess any active hemostatic agents such as thrombin.1 However, care should be taken not to aspirate COSEAL into extracorporeal autologous cell-saver circuits.

COSEAL can’t be used for patients on bypass. COSEAL can be used for patients on bypass, and it has been studied in an aortic clinical trial.4 Further, use of COSEAL on bypass may be the preferred method of use since the anastomotic sites are asanguinous and non-pressurized at this point in the procedure which may reduce the problematic issues of acheiving hemostasis once the patient is off-pump.

I’ve heard COSEAL is expensive.

Compared to what? In a randomized controlled trial, when COSEAL was compared to a similar product, it offered equivalent anastomotic sealing, but provided this desired effect in a significantly more rapid time frame.5 If one considers the potential costs associated with prolonged operative time, potential reoperation, or a prolonged hospital stay, the cost of COSEAL is not significant by comparison.8

Tips for Success• Work with staff to determine the focus of the surgeon and their current challenges.

• Prepare and demo product with surgeon and staff prior to case: – Use the Coseal Application Spraysheet as a tool to train the surgeon on ideal

application, and explain the advantages/disadvantages between the standard applicator and the spray applicator.

• Explain proper application to surgeon and staff : – Apply to a mainly dry surface. On-pump application is a good time for this. If there is

active bleeding present, bleeding can be stopped with FLOSEAL, and then sealed with COSEAL.

– Plan on the pathway for anastomotic application. If using the standard applicator, remind the surgeon to apply quickly (3-6 cm away from the vessel) and do not stop for a long period of time because the applicator can clog. If there are many anastomoses to perform, recommend use of spray applicator.

– Allow 60 seconds for COSEAL to polymerize before touching the anastomosis. • Discuss precautions before surgery regarding COSEAL. Refer to the Instructions for Use.2

Marketing MaterialsDescription

COSEAL Aortic Sales Sheet

COSEAL Trifold

Cardiovascular BioSurgery Brochure

Videos: CABG, Aortotomy, Aortic Root

Cardiac Reference OverviewArticle Title Reference Key Finding

Improved intraoperative management of anastomotic bleeding during aortic reconstruction: results of a randomized controlled trial.

Hagberg RC, et al. Am Surg 2004;70(4):307-11.

COSEAL exhibited greater proportion of immediate sealing at anastomotic suture-lines compared with control-treated (Gelfoam/thrombin) sites.

Reducing the incidence and severity of pericardial adhesion with a sprayable polymeric matrix.

Konertz WF, et al. Ann Thorac Surg 2003;7:1270-4.

Pediatric patients treated with COSEAL exhibited lower adhesion scores at five separate regions than untreated controls.

The use of a surgical sealant (COSEAL) in cardiac and vascular reconstructive surgery: an economic analysis.

Buskens E, et al. J Cardiovasc Surg (Torino) 2006;47(2):161-70.

A decision analysis model indicated use of COSEAL could potentially yield cost-savings by reducing both the need for blood products and operative time.

Script• COSEAL is a unique solution for cardiac surgery because it is a “2 in 1”

product that provides both anastomotic sealing and cardiac adhesion prevention.

• COSEAL adheres to tissue through covalent bonds and gels in 5 seconds with complete polymerization within one minute, reducing migration potential.1,2

• COSEAL is designed for high pressure sealing and can seal leak pressures of 660 +/- 150 mmHg (in vitro burst test for closure of puncture defects 0.6-0.9 mm in diameter in an animal model)7 which is 3x that of high (hypertensive) systolic aortic pressure,7 ensuring optimal performance in all cardiac anastomoses.

• COSEAL performs independent of the coagulation cascade and is unaffected by the patient’s coagulation status.1

• COSEAL is flexible and conforms to pulsatile anatomy, unlike other adhesives such as BIOGLUE.3

• COSEAL remains at the treated graft site for approximately 7 days, and is then completely eliminated from the body in 30 days.1 Future potential surgeries will not be challenged by the remnants of a permanent adhesive/sealant.

• COSEAL is 100% synthetic and contains no glutaraldehyde, or animal or human proteins, including thrombin.2 In a pivotal study, there was no adverse tissue response.5

• COSEAL provides a mechanical barrier between healing structures to protect against postoperative adhesion formation.6

• COSEAL may confer considerable economic benefits to hospital and health service budgets by reducing both the use of blood products and overall operative time.8

Challenges in Cardiac Surgery• Intraoperative and postoperative bleeding from anastomotic sites• Coagulopathy induced by cardiopulmonary bypass, anticoagulant/antiplatelet drugs,

and/or deep hypothermic circulatory arrest • High-pressure vascular anastomoses• Difficult-to-reach locations for hemostasis at completion of surgery

• Global withdrawal and use of aprotinin

• Increase in reoperative procedures with aging population

Probing QuestionsQuestions before COSEAL introduction:• Is it more challenging to achieve hemostasis in the typical cardiac surgery patient than it was 5-10

years ago?

• Has the withdrawal of aprotinin made the achievement of intraoperative hemostasis more challenging for you, including hemostasis at anastomotic suture lines?

• How has the increased use of Clopidogrel (Plavix) affected your patient’s ability to achieve hemostasis during surgery? While it is optimal to take patients off this therapy before surgery, how often do you have urgent cases in which this is not possible?

• What is your overall level of interest in blood management conservation? Do you think that intraoperative and postoperative bleeding from anastomotic sites is an important consideration?

• What is your current approach to achieving hemostasis at difficult anastomotic suture lines? Do you think it is something you should just address when bleeding occurs, or do you think a proactive approach to minimizing blood loss is more logical?

• How often do you experience challenging anastomotic situations because of friable and/or calcified tissue? What are the hemostatic challenges associated with this and how do you manage them?

• What are your concerns regarding postoperative pressure spikes (hypertension) and their impact on the anastomotic suture lines after the patient is awake or sits up for the first time?

• When performing a resternotomy on a cardiac patient, what challenges do cardiac adhesions create for you? What is your interest in technology to help reduce this burden?

Baxter Healthcare Corporation | Baxter Healthcare S.A. Postbox CH-8010 Zurich | www.baxterbiosurgery.comBaxter, FLOSEAL, and Advancing Surgery, Enhancing Life are trademarks of Baxter International, Inc. COSEAL is a trademark of Angiotech GmbH, used under license. BS-BS-364 November 2009

All other products or trademarks appearing herein are the property of their respective owners.

BioSurgery Advancing Surgery,Enhancing Life FOR INTERNAL USE ONLY

References 1. Hill A, Estridge TD, Maroney M, et al. Treatment of suture line bleeding with a novel synthetic surgical sealant in a canine iliac PTFE graft model. .J Biomed Mater Res. 2001;58(3):308-12. 2. COSEAL [Instructions for Use-EU]. Hayward, CA: Baxter Healthcare Corporation, 2009. 3. Azadani AN, Matthews PB, Ge L, et al. Mechanical properties of surgical glues used in aortic root replacement. Ann Thorac Surg 2009;87:1154–60. 4. Hagberg RC, Hazim JS, Sabik J, et al. Improved intraoperative management of anastomotic bleeding during aortic reconstruction: results of a randomized controlled trial. Am Surg 2004;70(4):307-11. 5. Glickman M, Gheissari A, Money S, et al. A polymeric sealant inhibits anastomotic suture hole bleeding more rapidly than gelfoam/thrombin: results of a randomized controlled trial. Arch Surg 2002;137(3):326-31. 6. Konertz WF, Kostelka M, Mohr FW , et al. Reducing the incidence and severity pericardial adhesion with a sprayable polymeric matrix. Ann Thorac Surg 2003;7:1270-4. 7. Wallace DG, Cruise GM, Rhee WM, et al. A tissue sealant based on reactive multifunctional polyethylene glycol. J Biomed Mater Res. 2001;58(5):545-55. 8. Buskens E, Meijboom MJ, Kooijman H, et al. The use of a surgical sealant (COSEAL) in cardiac and vascular reconstructive surgery: an economic analysis. J Cardiovasc Surg (Torino) 2006; 47(2):161-70.

Cardiovascular Anatomy

FOR INTERNAL USE ONLYBS-BS-364 11/09

Cardiovascular Procedures

FOR INTERNAL USE ONLYBS-BS-364 11/09