Perceval implant Key points REF. FSCA-HV-2016-001

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Patient pre-operative assessment

Perceval out of the jar

Surgical Technique

• Aortotomy

• Perceval implant related precautions

• Decalcification

• Sizing

• Guiding sutures

• Traction sutures

• Valve deployment

• Ballooning

• Inspection before closing the aorta

• Removal of the Guiding Sutures

• Prosthesis Removal Procedure

Patient pre-operative assessment

Preoperative patient assessment

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WARNING: Check that at the preoperative echo the ratio between the sinotubular

junction and the annulus diameter is ≤ 1.3. A ratio greater than 1.3 indicates a

condition of aortic root dilation for which Perceval S implant is contraindicated.

Transesophageal echocardiography (TEE) provides information on the aortic root geometry

allowing the measurement of the sinotubular junction (STJ) and the subsequent

calculation of the STJ to annulus ratio, which should be <1.3 for optimal seating of the

valve. Measurement of the sinotubular junction may be challenging without TEE.

Perceval out of the jar

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Perceval Out of the Jar

The valve as found in the jar does not coapt

completely. A symmetric shape can be seen, but

the leaflets do not coapt.

That is normal, in fact, Perceval has a larger

diameter than the indicated annuli range, in

order to apply a radial force for valve sealing and

anchoring once implanted.

When the valve is properly sized and implanted,

its inflow diameter is reduced to fit the patient’s

annulus and obtain leaflet coaptation.

Surgical Technique

Aortotomy

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The aortotomy is made transversely, higher than

what is used for traditional AVR. The reason is

that the Nitinol stent is longer than a traditional

valve and the outflow portion could interfere with

the closure of the aortotomy or may be caught

within the suture if the aortotomy is too low.

Aortotomy extension depends on the surgeon’s

preference; it is not recommended to overextend

the incision.

A transverse aortotomy located at least 3.5 cm above the aortic annulus or at least 0.5 cm above the sinotubular junction is considered optimal.

WARNING: Oblique aortotomy is not recommended since release of the device at the implant might result in aortotomy suture difficulties.

Perceval implant related precautions

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In case of concomitant procedures these must be performed as much as possible prior to Perceval S implantation.

After Perceval implantation, manipulation of the heart and/or of the ascending aorta, if required, should be done gently; should an atrial retractor be placed, take care not to compress the ascending aorta. These manoeuvres may lead to unknown effects on the implanted valve, including displacement and folding.

Decalcification

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Warning: Complete intra-annular

decalcification of the annulus is not

necessary, but eccentric/bulky protruding

intra-luminal calcifications must be removed.

Inadequate decalcification or residual calcium may

cause an uneven surface that can lead to

paravalvular leakage.

Bulky calcium deposits in the LVOT

might prevent optimal expansion of the inflow

portion of the stent. These deposits should be

addressed during the implant to avoid PVL and/or

incorrect valve positioning.

LVOT hypertrophy

may prevent optimal expansion of the inflow

portion of the stent.

In this case myectomy is recommended

Decalcification

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Decalcification is very important in the areas

close to the commissures.

Here the calcium deposits could impair the

commissural strut expansion.

Collar Seating

Commissural Strut

Sizing

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Each sizer represents the lower and upper limits of the

Perceval valve’s respective size.

It is recommended to start the sizing with the “S” sizer.

White obturators should not deform the annulus during

the sizing procedure. Avoid forcing the white obturator

through the annulus.

The importance of correct sizing

The appropriate size of the prosthesis is established

when the transparent obturator passes easily through

the aortic annulus into the left ventricle, and the white

obturator remains stable above the aortic annulus

Undersizing may lead to central or paravalvular

leakage, while oversizing may lead to elevated

pressure gradients or valve malfunction.

Ø in mm

S

M

L

XL

19 21

23

25

27

21

23

25

Ø in mm

Correct size

Proceed with next sizer

Sizing: what to do in case of doubt?

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Example: if you push with additional force, the white obturator will pass through the annulus

Suggestion: verify that the valve sizer has entered into the annulus perpendicular to the annular plane.

Then, if white obturator remains above the annulus or blocked within the annulus requiring firm traction

for retrieval, choose the same size valve (not the larger size).

REMEMBER:

There is no advantage in Perceval oversizing.

An oversized Perceval valve will not guarantee better hemodynamic performance. If oversized, Perceval

will likely show suboptimal expansion which could result in higher gradients.

TIP:

In a border line case, with the annulus right in between two sizes, consider the overall dimension of the

aortic root (sinuses and STJ width) for your size choice.

Guiding Sutures

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Correct placement of the guiding sutures is key to

the correct positioning of the valve.

Guiding sutures must be placed to hold the

traction applied during the implantation of the

device.

Position a guiding suture in each valve sinus, 2- 3

mm under the leaflet hinge point, perpendicular to

the annulus.

The 120 degree distribution of the sutures can be

ensured by using the sizers, as they have

reference spokes which are distributed at 120

degrees.

Guiding Sutures – LVOT Extremity Guidelines

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Avoid placing the guiding sutures too low in

the annulus.

The LVOT extremity should not be more

than 2-3 mm below the annulus.

The collar of the Perceval inflow should seat

above the annulus.

The LVOT extremities of the guiding sutures determine the depth of the valve.

Therefore, it is important that the guiding sutures are placed by inserting the needle in the

LVOT (below the annulus) and exiting above the annulus.

This prevents the valve from being deployed too low or too high in the aortic root.

annulus

Collar

Guiding Sutures – Aortic Extremity Guidelines

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The aortic extremity of the guiding sutures

provide an important reference point prior

to valve deployment.

Place the guiding sutures with aortic

extremity level at 2-3 mm above the

annulus. This will provide a good reference

for the positioning of the valve before the

opening of the inflow.

The rim of the collar should be at

approximately the same level of the exit

point of the guiding sutures.

Traction Sutures

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If using traction sutures, remember to

release the traction sutures prior to

valve deployment.

As traction sutures lift the annulus plane

upwards, they should be released prior to

Perceval implantation to avoid

misplacement of the valve after their

release.

Release

Release

Release

The use of traction sutures, placed at level of the

commissures, is not mandatory in Perceval

implantation.

However, their use may help visualization and

facilitate the positioning of the guiding sutures.

Surgical Technique – Traction of the Guiding Sutures

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All three guiding sutures must be pulled firmly

during valve deployment.

If tension is weak on one of the guiding sutures,

the valve could tilt to that side.

The guiding sutures should be pulled at a narrow

angle close to the holder.

Ensure that during valve deployment, you

are not preventing your assistants from

keeping all three guiding sutures properly

pulled at the correct angle.

Holder Shaft axis

Valve Deployment

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Assess valve alignment from the left, right and

non coronary sinus. As the nadir of the non

coronary cusp is lower, the holder should be

tilted toward the surgeon to ensure appropriate

seating of the valve at the annular level and

prevent PVL.

Rotate the knob at the end of the holder

clockwise (opened-lock arrow) until you hear a

click and “feel” the valve inflow ring being

released.

In this step, make sure you are not tilting

the holder which must be kept

perpendicular to the annular plane.

Ensure the sutures are not tangled around the

stent posts, which could interfere with the

proper seating of the device.

Valve Deployment

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Remove the Smart Clip and pull back the sliding

sheath of the holder.

Avoid rotational movements and keep the Holder

in an axial position with respect to the aorta.

Ensure that the guiding sutures are not trapped

in the stent struts.

The outflow of the valve will be released

following the withdrawal of the holder.

After deployment is complete, the holder should

be removed from the LVOT with gentle rotational

movements. Avoid tangling the holder in the

prosthesis.

Ballooning

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The balloon dilation provides optimal sealing of the valve

to the aortic annulus.

The balloon dilation does not cause deformation of the

stent.

Choose balloon that corresponds to the size of the valve

to be implanted.

During the balloon dilation, the catheter must be kept

absolutely steady to avoid misplacement or damage to

the prosthesis.

Ensure balloon is completely deflated before removing it

(retrieving the balloon not fully deflated may cause valve

displacement).

21

C

A

Before closing the aorta, the following checks should be performed: • Coronary ostia patency

• Proper valve positioning The pericardial sealing collar (C) should sit supra annularly while the inflow skirt (A) should sit intra annularly.

Annulus level

Inspection before closing the aorta

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Inspection before closing the aorta

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Valve positioning:

The collar of the Perceval seats supra-annularly

while the skirt of the inflow seats intra-annularly.

Therefore, if the annulus is visible from the top,

the valve is placed too low.

If the annulus is visible from the ventricular side,

the valve is positioned too high.

Check visually that sinusoidal struts are

juxtaposed at the Valsalva sinuses. Full apposition

of the outflow ring to the aortic wall at the level of

the STJ is not required. Post-dilation of the outflow

ring is not recommended.

A Perceval valve properly sized and implanted into the aortic root will show an even coaptation, with the rims of the leaflets at the same height. Note that the possible presence of a central limited space between the leaflet is intrinsic to the valve design, provided that is symmetrical and limited in extension. Verify that the prosthesis is well-anchored to the aortic root and that there is no lack of contact between the prosthesis and aortic annulus, potentially responsible for Para-prosthetic leaks. Aortic root filling maybe done at the physician’s discretion (hydraulic testing). By delicately using rounded pliers, leaflets should show an even coaptation with the rims of the leaflets at the same height .

Inspection before closing the aorta

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Removal of the Guiding Sutures

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Remove guiding sutures before closing the aortotomy.

To remove the guiding sutures, they must be cut right above the level of the

aortotomy.

The guiding sutures must not be tied. This may prevent optimal valve

seating and cause central or paravalvular leaks.

Potential risks due to tying of guiding sutures

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Tilted valve due to:

• improper guiding sutures positioning in unfavorable anatomy

• misplacement during knotting

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Distorted valve due to improper guiding sutures placement (not aligned to the valve eyelets, distributed at 120 degrees)

Prosthesis Removal Procedure

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Should it be necessary to remove the prosthesis from the implant site, proceed as follows:

Place crushed ice from a sterile physiological solution in the surgical area, ensuring that the ice comes

into contact with the prosthesis;

Wet the prosthesis with the iced physiological solution and simultaneously clamp the outflow section of

the prosthesis with three surgical forceps positioned at 120°;

Use the forceps to create radial compression on the prosthesis to reduce its diameter; the procedure is

performed holding the superior portion of the stent (outflow) at two opposite points and dragging them to

the center at the same time, forming an ‘χ’ . Using the ‘χ-movement’, the prosthesis can be easily

removed (*).

After detachment of the prosthesis from the aortic wall, extract the forceps and prosthesis as if they were

a single device, do not damage the surrounding tissue.

A removed Perceval prosthesis MUST NOT BE REIMPLANTED, as its integrity is no longer

guaranteed.

(*) Santarpino G. et al. “A supra-annular malposition of the Perceval S sutureless aortic valve: the ‘χ-movement’ removal technique and subsequent reimplantation” Interactive CardioVascular and Thoracic Surgery 15 (2012) 280–281

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Closing the aorta

Make sure the closing suture does not

catch the stent by any means.

Since the level of the aortotomy will

move distally with respect to the annulus

after declamping, catching the frame

bears the risk of dislodging the valve

into the aortic root.

Therefore, every stitch of the suture has

to be carried out with visual inspection

to ensure exact closure.

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Intraoperative post-implant Echo

Intraoperative post-implant echo is an

important step for quality control in

every valve procedure.

In the setting of sutureless implantation,

it prevents late detection of device

malfunction or regurgitation following

the procedure.

Note: after declamping, especially in

cases of low pressure, a trivial central

leakage may be detected. This most

likely disappears in a few hours once

diastolic pressure is restored.

If greater leakage is detected, check

valve sizing and positioning to assess the

need for valve explant.

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