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reconstruction is typically only needed when considering tricuspid valve-in-ring therapy, and a

3D print model may be helpful for preprocedural planning.

If available, the manufacturer’s card or the surgical operative report is reviewed to check for the type and size of the surgical prosthesis. After that, transcatheter valve sizing is done using the VIV mobile application, which gives the transcatheter valve sizing according to the BPV true internal diameter. Sizing can also be conﬁrmed using a preprocedural cardiac CT scan (contrast CT if possible), which measures the actual internal diameter that can sometimes be smaller than the expected internal diameter if there is stenosis or pannus formation. In cases where prosthesis sizing remains questionable by imaging, balloon sizing during the procedure can be performed by inﬂating a balloon of a particular size across the surgical valve and looking to see if a waist develops, which is a sign of adequate seal. The waist can then be measured to determine the internal diameter.

Off-label use of currently available valve technology is planned; the two valves most commonly implanted are the Melody (Medtronic, Inc., Minneapolis, MN) and Sapien S3 (Edwards Lifesciences, Irvine, CA).

Valve Selection

Sizing of the surgical BPV can be done with traditional known methods (VIV applications) or by balloon sizing at the time of the procedure to determine the inner diameter of the existing BPV (Fig. 24.1). The Melody valve system can be safely implanted into all BPVs with an outer diameter of 25 mm at the time of surgical implant. The delivery catheter for the Melody is a 22-mm, balloon-in-balloon, fully covered system that expands the Melody valve to an outer diameter of approximately 24 mm when fully deployed. If the balloon-sizing method used at the time of the procedure demonstrates that the waist on the balloon is less than 24 mm, then a fully deployed Melody will ﬁt well, even when manufacturer’s speciﬁcations indicate a much larger valve; this is typically due to leaﬂet restriction, calciﬁcation, thickening, and/or pannus ingrowth. Implantation of the Sapien valve into a BPV 27 mm or greater is typically performed, again with size being determined by typical VIV speciﬁcations. Certain types of BPV may be fractured to improve inner diameter. Consideration may be given to fracture of the existing BPV, particularly if smaller diameter, with a high-pressure balloon prior to valve implant.

Fig. 24.1 The 22-mm Z-Med balloon is inﬂated within the Medtronic Mosaic bioprosthesis; a waist is present at the sewing ring (arrows). The exchange wire is positioned deep within the right pulmonary artery (tip not visualized) and the intracardiac echo catheter (*) is positioned in the right atrium.

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Procedure: Step-by-Step Approach

1. If preprocedural transthoracic echocardiographic (TTE) images are adequate or intracar-

diac echocardiography (ICE) is available, the procedure can be done under conscious sedation. Alternatively, if transesophageal echocardiogram is required for intraprocedural imaging, general anesthesia is often used.

2. Access is obtained in the femoral vein using a 7F sheath under ultrasound guidance, using

usual techniques with or without preclosure with one Perclose device.

3. A small arterial sheath is often also used in the femoral or radial artery for hemodynamic

monitoring.

4. A balloon wedge catheter (Teleﬂex, Morrisville, NC) is then advanced into the pulmonary

artery and placed in a wedge position. The left pulmonary artery is preferred over the right, as it may provide better alignment for positioning and deployment of the device.

5. Once the balloon wedge catheter is in position, an exchange-length Amplatz super-stiff

0.0350 wire is then advanced through the balloon wedge catheter and placed distally.

6. The balloon wedge catheter is then removed over the stiff wire.

7. The 7F sheath is removed and is upsized to a 14F or 16F Edwards eSheath over the stiff

wire.

8. The Edwards Sapien S3 valve is then mounted with an atrial orientation of the skirt.

9. The transcatheter delivery system is then inserted into the inferior vena cava (IVC) and

assembled, then positioned across the tricuspid prosthetic valve sewing ring using an orthogonal ﬂuoroscopic angle (see Fig. 24.2). The position of the Sapien S3 valve should be positioned such that the central marker is just ventricular to the prosthesis sewing ring.

10. After conﬁrming positioning on ﬂuoroscopy, deployment starts with a slow inﬂation.

Once a stable position is reached, deployment is completed by fully inﬂating the balloon over a period of 6 to 8 seconds. Adequate anchoring is conﬁrmed ﬂuoroscopically by seeing a waist around the transcatheter ring, as well as using echocardiography to assess for the presence of periprosthetic or prosthetic leaks. Rapid pacing is not needed for this procedure; however, in rare instances, transcatheter valve positioning can be challenging

A B

Fig. 24.2 (A) A small curve Safari wire is positioned in the dilated right ventricle, and the Sapien valve is advanced into the existing bioprosthesis (St. Jude Epic with thin ﬁlament visualized in annulus/sewing ring). Adjustment would be made with respect to positioning this valve more proximally before deployment is carried out. (B) Small curve Safari wire positioned with curve down in the apex of the dilated right ventricle for positioning of the Sapien valve into this Hancock II bioprosthetic valve.

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and rapid pacing can be helpful. This can be done using right atrial, left ventricular pacing with a balloon-tipped pacemaker or coronary artery septal branch pacing through a coronary wire insulated in a microcatheter and connected to the pacemaker externally.

11. The delivery system is then retracted over the wire into the IVC.

12. Once adequate deployment is verified, the balloon wedge catheter is then brought

up again over the stiff wire into the wedge position. The stiff wire is then carefully removed.

13. Finally, the femoral vein sheath is removed and the Perclose suture is deployed to achieve

adequate hemostasis.

An acceptable result is a well-seated transcatheter valve with some waist seen at the areas of contact with the surgical valve ring, with no evidence of more than mild periprosthetic or prosthetic leak, as well as less than 5 mmHg diastolic gradient across the tricuspid valve.

Tips, Tricks, and Pitfalls

1. Access sheath: Femoral venous access is most commonly used, although internal jugular

access is also possible. When planning for Melody valve deployment, the Ensemble delivery system is designed to be advanced percutaneously without a guiding sheath, as the valve remains fully covered until advanced into the desired position. A 22F DrySeal sheath (Gore Medical, Newark DE) will accommodate the 22F delivery system without the need for multiple catheter exchanges over the guidewire. A 16F eSheath is used for Sapien implant.

2. Wire positioning: Standard right heart catheterization is performed during this procedure.

In the setting of severe tricuspid stenosis and/or regurgitation, it may be difﬁcult to cross easily, and biplane visualization of the valve ring is very useful. A Glidewire may be used to assist catheter crossing. If a pulmonary artery (PA) wire is planned, the 7F balloon wedge catheter can be positioned deeply in the right or left pulmonary artery with the use of this angled Glidewire. An exchange-length 0.0350 wire, typically a Lunderquist (Cook Medical, Bloomington, IN) or Amplatz super-stiff or extra-stiff (Boston Scientiﬁc, Marlborough, MA) wire, is positioned deep in the PA for most valve deployments. With the balloon inﬂated on the wedge catheter to maintain position of the tip, the stiff exchange wire is then positioned to the tip of the wedge catheter and left in place as the wedge catheter is withdrawn. The left PA may be favored to visualize the tip of the wire during valve manipulation, particularly when using the Sapien system and mounting the valve onto the balloon in the IVC. When using a stiffer wire, it is important to monitor the wire tip at all times to prevent distal PA branch injury.

An alternative method is to position a small curve Safari wire (Boston Scientiﬁc, Marlbor-

ough, MA) directly into the apex of the right ventricle (RV) (Fig. 24.3). This technique is particularly useful when the RV is known to be severely dilated, as the wire curve can be accommodated in the apex of the RV; this technique is unlikely to be successful when the RV is smaller or hypercontractile. To deploy the stiff Safari wire successfully into the RV, the right atrial–to–tricuspid valve curve needs to be maintained with a steerable sheath such as the Agilis (Abbott, Abbott Park, IL) or Dexterity sheath (Spirus Medical, Stoughton, MA). A “mother–child” catheter combination of 6F multipurpose guide with 5F multipurpose catheter or the 7F balloon wedge catheter can then be manipulated into the apex of the RV for positioning of the Safari wire.

3. Valve positioning/deployment: Typical radiographic landmarks are utilized for valve posi-

tioning, and angiography is not usually needed. In general, positioning the anteroposterior (AP) camera so that the radiographic landmarks of the valve are seen from the side (i.e., valve leaﬂet markers and sewing ring superimposed on itself ) provides the best imaging

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A B

Fig. 24.3 If a pulmonary artery (PA) wire is planned, the 7F balloon wedge catheter can be positioned deeply in the right or left pulmonary artery with the use of an angled Glidewire. (A) Initial positioning of the Melody valve into a St. Jude Epic tricuspid bioprosthesis (arrows) with the guidewire positioned into RPA. The carrot tip of the Ensemble delivery system can be visualized (*). (B) Positioning of the Sapien valve into the tricuspid bioprosthesis with the pusher catheter against the valve (arrow). The Lunderquist wire is positioned deep within the left pulmonary artery (*).

plane for valve positioning and deployment (Fig. 24.4A). Rarely does the orthogonal view

(i.e., “en face” view) provide additional imaging information once the tricuspid valve has

been crossed. In most situations where the wire is positioned into the pulmonary artery, the

delivery system appears to be more vertically oriented within the existing bioprosthetic

tricuspid valve, directed toward the pulmonary outﬂow tract (see Fig. 24.4B). However,

once valve inﬂation begins, one typically sees a more coaxial positioning and adjustment into

proper alignment as the valve is fully deployed. The valve must be anchored on the existing

BPV sewing ring, so the operator must be familiar with radiographic landmarks of the exist-

ing surgically placed valve or valve ring. In general, one should see a small amount of ﬂaring

of the valve on either side of the surgical ring with a slightly more ventricular deployment.

Pacing is rarely necessary, as a controlled, careful deployment can be achieved.

a. Melody Valve: The Melody valve delivery system completely contains the valve until it

is uncovered by the operator after delivered into the desired position. As this delivery system was designed for pulmonary valve positioning, there are rarely issues achieving satisfactory position within the tricuspid BPV. However, if difﬁculty is encountered, a small portion of the valve can be uncovered to provide some “ﬂexibility” of the delivery system if needed. A small amount of valve repositioning may be necessary after the valve is fully uncovered. The Melody valve has a balloon-in-balloon deployment mechanism where the inner balloon can be inﬂated and small adjustments in positioning performed after inner balloon inﬂation (Fig. 24.5A). Once the position is secure, outer balloon inﬂation fully delivers the 22-mm Melody valve into the existing BPV (see Fig. 24.5B–D). Both inner and outer balloons are then deﬂated, and a separate outer-balloon-only inﬂation is performed. One should see a small amount of ﬂaring of both ends of the valve, which provides secure positioning.

b. Sapien Valve: The Sapien valve is advanced through the eSheath and mounted onto the

balloon in the IVC under ﬂuoroscopic visualization (monitoring the position of the distal wire tip if in the pulmonary artery), usually with the E down on the eSheath, but vBPV can be accomplished with the pusher catheter in a typical position, but if the operator encounters difﬁculty, it may help to bring the pusher catheter back and

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Fig. 24.4 (A) During initial deployment of the Melody valve, the inner balloon is inﬂated, at which point minor adjustments in position can be made. (B) Outer balloon inﬂation will deliver the Melody valve to a full diameter of 22 mm, expanding it into the existing bioprosthesis. (C) Final delivery position with radiopaque stent support of the Melody valve well expanded within the St. Jude epic bioprosthesis (sewing ring, arrows). (D) Orthogonal view to demonstrate the fully expanded Melody valve within the bioprosthetic valve.

advance the valve/balloon independently. Tension in the catheter system should be released, and if signiﬁcant difﬁculty is encountered, a small amount of balloon inﬂation at the tip might aid in crossing the tricuspid valve. A slow, careful deployment can be performed without the need for rapid pacing, remembering that the Sapien S3 valve shortens from the atrium toward the ventricle (Fig. 24.6). In most situations, the center mark of the valve balloon should be positioned just a few millimeters “ventricular” to the valve sewing ring/annulus. When deploying into a large bioprosthetic valve (e.g., 31 to 33 mm), 1 to 4 extra cubic centimeters of volume may be utilized to achieve additional expansion.

4. Imaging: All modalities of echocardiography can be utilized during TVIV procedures.

This procedure can be carried out safely with conscious, moderate sedation, in which case ICE or TTE is preferred. Transesophageal echocardiography (TEE) typically requires general anesthetic for patient comfort, and image quality may not be satisfactory, especially in comparison to ICE imaging. TTE apical views are generally preferred for imaging of

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Fig. 24.5 Fully deployed Sapien valve within the 33-mm St. Jude Epic valve, with slight ﬂaring or proximal end with positioning of valve at sewing ring (arrows). Small curve Safari wire is seen in right ventricle (*).

Fig. 24.6 Intracardiac echo imaging before and after Melody tricuspid valve-in-valve. All imaging was performed with probe in right atrium. (A) Retracted thickened tricuspid bioprosthetic leaﬂets are visualized. (B) Color Doppler showing severe transvalvular regurgitation (arrow). (C) After Melody valve deployment, the leaﬂet coaptation (*) can be seen deep within the Melody valve stent. (D) Color Doppler demonstrates trivial transvalvular regurgitation and no evidence of intervalvular leak. RA, Right atrium; RV, right ventricle.

the tricuspid valve during the procedure, but may also be challenging with the patient in

the recumbent position. ICE imaging is simply obtained from the “home view” with the

probe positioned in the right atrium (Fig. 24.7A and B). Detailed imaging of the valve

should be performed before conclusion of the procedure, evaluating both intervalvular leak

(regurgitation between the newly deployed transcatheter valve and the preexisting BPV)

and function of the valve leaﬂets (see Fig. 24.7C and D).

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Fig. 24.7 Intracardiac echo imaging before and after Sapien tricuspid valve-in-valve. All imaging was performed with probe in right atrium. (A) Color Doppler on left side of panel shows severe transvalvular regurgitation (arrow) with thickened tricuspid bioprosthetic leaﬂets seen on right side of panel (*). (B) After Sapien valve deployment, there is trivial transvalvular regurgitation seen on left side of panel (arrow) with a nicely positioned stent seen within the existing bioprosthetic valve (BPV) on the right side of the panel. RA, Right atrium.

Outcomes

The largest registry study with TVIV implantation included 152 cases from 53 centers. The procedural success rate of TVIV implantation was 98.7%. There was one procedural death, two cases of periprosthetic leak, and two cases of tricuspid stenosis immediately after the procedure. Over a 13-month follow-up period, a total of 22 patients died. Four patients developed valve failure due to thrombosis and leaﬂet immobility. Nine patients required surgical replacement, and two patients underwent repeat VIV procedure.

Complications

PULMONARY ARTERY LACERATION

Any hemoptysis or blood in the endotracheal tube should raise the concern of pulmonary vessel injury. As TVIV therapy does not involve as much catheter manipulation as PA branch or pulmonary valve therapy, this complication is rare. To prevent this complication, it is important to use the balloon wedge catheter for wire exchanges, especially the stiff wires, and continuously ensure the distal tip of the wire does not advance too far. The operator should have the appropriate coils or vascular plugs and delivery systems available to appropriately treat and embolize any vessel injury if needed.

PERIPROSTHETIC LEAK

Because the stiff wire is positioned into the left PA at an angle with the surgical ring, transcatheter valves are usually deployed at an angle and align with the surgical valve once deployment is complete. However, a tilted deployed position can still occur in some cases, which can lead to periprosthetic leak. Moreover, undersizing and valve migration can also lead to periprosthetic leak. If more than mild periprosthetic leak is present along with symptoms or hemolysis, then paravalvular leak closure would be indicated.

INTERVALVULAR REGURGITATION

Intervalvular leak or regurgitation between the newly deployed transcatheter valve and the existing BPV is rarely seen, but is slightly more common with the Sapien valve. Inﬂation of the

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transcatheter valve with additional volume may obliterate the leak. Careful echocardiographic assessment is necessary, and if the leak is determined to be mild, it may be left as is, rather than placing the new transcatheter valve at risk of embolization during excessive catheter manipulation.

VALVE EMBOLIZATION

Valve embolization is possible if the valve is improperly positioned before deployment or sizing is not performed to speciﬁcations—certainly there is more risk when implanting into a tricuspid valve annuloplasty ring. Wire position should not be lost. If the valve is found to be undersized during balloon inﬂation by evidence of lack of anchoring on the annulus, the balloon can be kept in the inﬂated position with the valve secured on the balloon and pulled back into the IVC for deployment.

If wire position is lost so there is no longer a wire through the embolized valve, valve retrieval

can be attempted using snaring techniques with an En snare (Merit Medical, South Jordan, UT) or Amplatz Gooseneck (Medtronic, Minneapolis, MN) snare devices, which can then help position the valve in the IVC and deploy it there in the proper orientation. If this is not successful, surgical removal is warranted.

CHAMBER PERFORATION

Right-sided chambers are thin and vulnerable to device-related perforation. Care should be taken during delivery, deployment, and retrieval of equipment. Pericardial effusion detected on imaging or tamponade should raise this suspicion. This would require emergent pericardiocentesis with negative pressure to seal the perforation and surgical intervention if bleeding continues.

VASCULAR BLEEDING

Bleeding is a rare complication of large-bore venous access and should be monitored accordingly. We use one Perclose suture deployed in a preclose fashion. If for some reason the Perclose is not successful, a ﬁgure-of-8 stitch can be done and is usually successful in controlling venous bleeds.

Postprocedural Management

Patients are typically treated with aspirin indeﬁnitely and warfarin therapy at least for the ﬁrst 3 months. Baseline valve gradients, leaﬂet function, and degree of regurgitation should be documented by echocardiography, both intraprocedurally and before hospital discharge. Regular surveillance echocardiography is warranted for any patient who has undergone VIV therapy.

We then suggest monitoring of valve function by TTE at a 3- and 6-month interval, then

annually, at a minimum, depending on the clinical status of the patient. If there is any suggestion of increasing valve gradient, anticoagulation therapy should be adjusted accordingly. Infective endocarditis prophylaxis is warranted on a lifelong basis.

Summary and Key Points

Catheter-based TVIV therapy is an attractive option for repeat intervention on the tricuspid

valve, especially in patients with previous sternotomy and/or signiﬁcant comorbidities.

The two most commonly implanted valves are the Melody and Sapien S3.

Intraprocedural imaging is usually performed using TTE and/or ICE. Obtaining good-

quality images is often more difﬁcult with TEE compared with left-sided valves.

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