Figure 1

Device description

The Carpentier-Edwards PERIMOUNT Plus mitralpericardial bioprosthesis, model 6900P, and theCarpentier-Edwards PERIMOUNT Theon mitralpericardial bioprosthesis, model 6900PTFX, arecomprised of bovine pericardium leafletsmounted on a flexible metal alloy frame. Bothvalves are built upon the proven performanceof model 6900 in clinical use since 1984.1,2

The valve profile, shape and mountingtechniques have been specifically engineered to enhance durability by increasing tolerancefor the high pressure under which a mitralbioprosthesis functions.

Carpentier-Edwards PERIMOUNT mitral valvesare compatible with the following accessories(Figure 1):

- Handle model 1117

- Sizers model 1169HP

- Tray model TRAY1169HP

Implantation

The Carpentier-Edwards PERIMOUNT valve isimplanted using standard surgical techniques.Key steps to a successful implant include:

1.Proper sizing with the appropriate valve sizers.

2.Proper preparation and seating of the bioprosthesis using the handle and properly deployed holder.

3.Proper use of the holder; tying sutures with the holder in place to avoid looping around the stent.

4.Proper assessment of function, both by direct vision before closure, then with postoperative TEE.

1. Sizing

Use only Edwards sizers 1169HP to size forCarpentier-Edwards PERIMOUNT mitral valves,models 6900P and 6900PTFX, as their keydimensions correlate with those of the valves(Figure 2):

- the barrel’s external diameter matches the valve’s external diameter (OD),

- the lip of the sizer mimics the sewing band.

Carpentier-Edwards PERIMOUNT Mitral Valves Models 6900P and 6900PTFX

Sizing and Implantation Technique

Figure 2

Sizer Lip

Barrel External Diameter

Valve Sewing Band

Valve External Diameter (OD)

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1.1 Do not oversize!Oversizing may cause valve damage or localizedmechanical stresses, which may in turn injure theheart or result in tissue failure, stent distortion andvalve regurgitation. The excellent hemodynamicperformance of the PERIMOUNT mitral valve acrossall sizes makes oversizing unnecessary (Figure 3).

Sizers 1169HP are labeled with both the valve sizeand the mean effective orifice area (EOA) in cm2

(Figure 4). These in vivo EOA values were obtainedthrough three multicentric prospective studiesconducted between 1984 and 1997 at the 1- to 2-year post-implant interval. Having access to boththe labeled size and the EOA at the time of surgeryprovides clinically relevant information on theexpected hemodynamic performance. This may helpsurgeons determine the right size for a particularpatient, and prevent oversizing.

1.2 Sizing according to the suture techniqueLike other mitral bioprostheses, PERIMOUNT mitralvalves are usually implanted using pledgetedmattress sutures. The pledgets may be placed eitheron the atrial or ventricular aspect of the annulus(Figure 5). The suggested suture technique isventricular placement of the pledgets or non-everting sutures as this allows the valve andannulus to seat in the most natural position and isoften preferred in the case of a calcified annulus.

When sizing for non-everting suturing techniques,the sizer barrel should comfortably fit whenintroduced into the annulus. The sizer lip should beseated on top of the annulus as the sewing bandwill be later. It is important to account for apossible decrease in the size of the valve that canbe implanted when chordal preservation techniquesare used.3,4

Figure 5

Figure 4

Figure 3Hemodynamic Performance

0

0.9

1.8

2.7

3.6

2.32.6 2.6 2.5

1.8

Valve Size

25 mm 27 mm 29 mm 31 mm 33 mm

In vitro Clinical EOA at 1-2 yr post implant cm2

3 40 47 27 4n=

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2. Preparation and seating of the prosthesis

As with any stented mitral bioprosthesis, specialcare must be taken during implantation to avoidlooping a suture around one of the stent posts orinserting a post behind a strand of chordal tissuewhen chordal preservation techniques are used.

2.1 Deploy the Tricentrix holder system

The Tricentrix holder system (Figure 7) facilitatesimplantation while maximizing visibility. Itsinnovative tenting system protects the stent fromentrapping a loose suture. The three stent postsretract toward the center of the valve when theTricentrix holder system is fully deployed. To deploythe Tricentrix holder system, these steps must befollowed:

- Insert the handle 1111 or 1117 (reusable) or 1126 (disposable) and turn clockwise until snug fit. Once the handle has been attached, it should not be removed until the valve is seated in the annulus.

- Grasp the plastic sleeve and rotate the handle clockwise an additional 1/4-turn until the holder reaches the unlock position; then push on the handle until the post snaps into its fully deployed position (Figure 8).

- Remove the sleeve and clip. The sleeve is removedby pulling away from the rest of the assembly.The clip then is removed by sliding away from theholder. Rinse the valve two times, one minute each, in separate saline bowls filled with at least 500 ml saline.

- Check for proper deployment; the holder should be locked. There should be no space between thebase of the white post and the holder, and no sliding movement (Figure 9).

Should the surgeon suspect that the holder is notfully deployed when handed the valve, he or shecan complete the deployment by gently holding thevalve sewing band, unlocking the post, and pushingon the handle until the tenting structure isproduced and the post snaps into position.

Figure 8

Figure 9

Figure 7

Check

Rotate Push

Properly deployed holder system

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2.2 Valve orientationThe PERIMOUNT mitral valve is symmetrical andoffers three identical leaflets without muscleshelves. The valve should be positioned to avoidobstruction of the left ventricular outflow tract(LVOT) by the stent posts. Two black suture markersaid in the orientation of the valve and indicatewhere the stent posts are positioned.

The PERIMOUNT mitral valve has a low profiledesign with short stent posts. This feature alsominimizes the risk of LVOT obstruction and the riskof ventricular damage in patients with a smallventricular cavity.

2.3 Valve seating

It is important to maintain firm tension on thesutures as the valve is lowered into the annulus toprevent formation of suture loops that mightentrap a leaflet (Figure 10). The 1117 handle islonger and has a flexible shaft to help reachdifficult exposures and to facilitate valve seating.

3. Tying sutures with the holder in place

3.1. Handle removalOnce the valve is seated, the handle of the valveholder system may be removed prior to tying thesutures. This is easily achieved without unscrewingit: the handle and adapter are removed as anassembly. Maintain the valve placement in theannulus by gently placing forceps or gloved handsonto the holder.

Cut the single green adapter attachment thread bythe handle and removethe adapter and handleassembly as one unit(Figure 11). Do notunscrew the handle as this may unseat orrotate the valve,creating the potentialfor a loose suture.

3.2. Avoid suture looping

To avoid suture looping, it is essential to leave the deployed Tricentrix holder attached to the valve until all knots are tied.

The Tricentrix holder system has short legs androunded edges for ease of suturing and a very lowprofile for increased visibility.

However, if leaving the holder in place obstructsthe surgeon's view or makes tying knots difficult, atleast all the sutures to each side of the three stentposts MUST be tied down before cutting the threeholder attachment threads to remove the holder.

Do not cut the deployed holder attachment threadsbefore these adjacent sutures are tied down. If theattachment threads are cut before tying thesutures, the holder tenting structure will beeliminated and can no longer prevent suturelooping around the stent posts. In addition, thevalve could also unseat or partially separate fromthe annulus during the removal of the holder,loosening the sutures which may in turn result in asuture loop.

Figure 11

Figure 10

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3.3. Tricentrix holder removalOnce all knots are tied, the holder is easily removedby cutting each of the three green exposed threadsusing a scalpel or scissor placed in the cuttingchannel, then removing the holder system as a unit,along with attaching sutures using sterile glovedhands or protected forceps (Figure 12).

4. Assessment of the valve function 4.1. Direct vision assessmentOnce the holder is removed it is important tovisually assess the function of the valve. The leafletsshould appear symmetric; any leaflet distortionsuggests a technical problem. It is recommended tovisually inspect each of the leaflets to ensure thevalve is free of suture loops or anatomicalobstructions that may interfere with the functionof the valve.

The PERIMOUNT valve design incorporates a smallcentral free space at rest. This space is intended torelieve stress on the tissue and to contributethereby to the long-term performance of the valve.It closes under even low physiological pressure.However, the “water test”, which is filling the leftventricle with saline using a syringe, widely used inmitral valve repair, is not recommended to test thePERIMOUNT mitral valve.

4.2. Echocardiographic assessment

As with any heart valve operation, intraoperativepost-bypass transesophageal echo verification ofvalve function prior to heparin reversal anddecannulation is essential.5 Normally functioningvalves demonstrate no or mild central regurgitationarising from the free space at the center of thevalve. Occasionally one or more trivial jets arisefrom the coaptation edge of the leaflets andoriginate at the stent posts. All of these flowpatterns are physiologically insignificant andcomprise this valve’s signature flow pattern.Additional flow patterns observed include minorjets originating from the sewing ring cloth thatmay be observed prior to administration ofprotamine. Unlike the signature flow pattern, thesejets typically resolve shortly after reversal ofheparin. Similarly, as the patient returns tophysiologic pressures following cardiopulmonarybypass, the appearance of the central jet diminishesuntil only trivial or mild signature flow remains.6

Abnormal flow patterns include moderate (2+) orgreater central or eccentric regurgitation. Excessiveregurgitation, especially severe regurgitation or arestricted appearance of the leaflets onechocardiographic assessment may indicate anentrapped leaflet and requires reinstitution ofcardiopulmonary bypass and re-opening of theatrial incision for further assessment (Figure 13).

Figure 13

Figure 12

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Edwards Lifesciences LLC · One Edwards Way · Irvine, CA 92614 USA · 949.250.2500 · 800.424.3278 · www.edwards.com

Edwards Lifesciences (Canada) Inc. · 1290 Central Pkwy West, Suite 300 · Mississauga, Ontario · Canada L5C 4R3 · Phone 905.566.4220 · 800.268.3993

Edwards Lifesciences S.A. · Ch. du Glapin 6 · 1162 Saint-Prex · Switzerland · Phone 41.21.823.4300

Edwards Lifesciences Japan · 2-8 Rokubancho · Chiyoda-ku, Tokyo 102-0085 · Japan · Phone 81.3.5213.5700

The surgical technique presented in this material is the techniqueused by Kevin D. Accola, MD. Edwards Lifesciences does not endorseany particular surgical technique.

Kevin D. Accola, MD is a paid consultant to Edwards Lifesciences.

Rx only. See instructions for use for full prescribing information.

Edwards Lifesciences devices placed on the European market meetingthe essential requirements referred to in Article 3 of the MedicalDevice Directive 93/42/EEC bear the CE marking of conformity.

Edwards and PERIMOUNT Theon are trademarks of EdwardsLifesciences Corporation. Edwards Lifesciences, the stylized E logo,Carpentier-Edwards, PERIMOUNT, PERIMOUNT Plus and Tricentrix aretrademarks of Edwards Lifesciences Corporation and are registered inthe United States Patent and Trademark Office.

© 2007 Edwards Lifesciences LLCAll rights reserved. AR02178

References1. Marchand MA, et al. Fifteen-Year Experience With the Mitral Carpentier-Edwards PERIMOUNT

Pericardial Bioprosthesis. Ann Thorac Surg 2001;71:S236–9.2. Data on file at Edwards Lifesciences - 16 YEAR RESULTS Carpentier-Edwards PERIMOUNT Mitral

Pericardial Bioprosthesis, Model 6900 CLINICAL COMMUNIQUE3. Aagaard J, et al. Mitral valve replacement with total preservation of native valve and subvalvular

apparatus. J Heart Valve Dis. 1997 May;6(3):274-8; discussion 279-80.4. Yu Y, et al. Mitral valve replacement with complete mitral leaflet retention: operative techniques. J

Heart Valve Dis. 1999 Jan;8(1):44-6.5. Shanewise JS et al: ASE/SCA guidelines for performing a comprehensive intraoperative multiplane

transoesophageal echocardiography examination: Recommendations of the American Society of Echocardiography Council for Intraoperative Echocardiography and the Society of Cardiovascular Anaesthesiologists Task Force for Certification in Perioperative Transesophageal Echocardiography.J Am Soc Echocardiogr 1999;12:884-900.

6. Morehead AJ et al. Introperative echocardiographic detection of regurgitant jets after valve replacement. Ann Thorac Surg 2000;69:135-139.

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