Anterior Tilted Deployment of EVOQUE Transcatheter Tricuspid Valve Replacement System: Overcoming Inadequate Implant Depth

Abstract

Transcatheter tricuspid valve (TV) replacement (TTVR) with the EVOQUE system is the first and only Food and Drug Administration–approved replacement option for patients with ≥ moderate tricuspid regurgitation despite optimal medical therapy. Several anatomical considerations affect procedural success. Transfemoral (TF) access is the preferred approach but can be challenging. It is influenced by the inferior vena cava (IVC)–to–tricuspid valve annulus (TVA) offset as well as the working room length. The latter combines right atrium (RA) height and right ventricle (RV) depth and is affected by the IVC–TVA distance. In cases where the right atrial height is short (<60 mm), the standard TF deployment may be hindered due to deep capsule position in the RV, which can cause chordal entanglement and affect trajectory. In such scenarios, mitigation strategies such as wire manipulation or secondary flex may be required. When those maneuvers are insufficient, left femoral venous access or transjugular (TJ) approach may be necessary. Here we describe a novel deployment technique to facilitate successful valve implantation as an added strategy to overcome lack of right atrial height while maintaining femoral access. The anterior tilted deployment strategy described here ensures optimal valve placement and function, reducing the risk of procedural complications related to limited height in the RA and the need to switch access intraprocedurally. This method highlights the adaptability of the EVOQUE system in managing complex cardiac anatomies.

Highlights

• •Inadequate implant depth can be challenge during transfemoral EVOQUE transcatheter tricuspid valve replacement.
• •Multiple techniques to gain height may be needed including wire manipulation, left femoral approach, secondary flex with counterclockwise rotation, or alternately transjugular approach may be needed.
• •The new RVOT technique can be used to overcome inadequate implant depth during transfemoral deployment of EVOQUE transcatheter tricuspid valve replacement.

EVOQUE Transcatheter Tricuspid Valve Replacement System

The EVOQUE transcatheter tricuspid valve (TV) replacement (TTVR) system (Edwards Lifesciences, Irvine, California) is the first and only Food and Drug Administration–approved transcatheter valve replacement for patients with ≥ moderate, symptomatic tricuspid regurgitation despite optimal medical therapy. The EVOQUE valve is deployed using a transfemoral (TF) venous approach, and the procedural technique has been previously described.¹ The valve consists of a 28-mm trileaflet bovine pericardial tissue valve, a self-expanding nitinol frame with nine anchors that engage and capture the native tricuspid leaflets, and a fabric skirt. The in-line delivery system has an outer diameter of 28 F and a handle that contains a primary flex knob, a secondary flex knob, and a depth knob to facilitate valve alignment and positioning within the TV. A separate capsule knob and release knob control the expansion and release of the valve housed in a capsule at the distal end of the delivery system. The depth knob helps achieve a deeper position in the right ventricle (RV), while the primary flex and secondary flex knobs control the trajectory and position of the device. The depth knob cannot bring the valve atrially from its initial height. The delivery system requires a stiff wire with a pigtail configuration (Safari wire; Boston Scientific, Boston, Massachusetts) in the RV apex.

The EVOQUE system is designed for TF delivery. TF access, particularly from the right side, is often favored due to its routine use in most transcatheter structural heart procedures. In the TRISCEND II study (Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device), 89.1% of patients underwent TTVR via the right femoral vein, with left femoral access used in 10.9% of cases.² The interplay between anatomical structures within the right side of the heart, including the inferior vena cava (IVC), right atrium (RA), IVC–TV annulus (TVA) offset, and RV papillary muscles, can affect right-sided access. Computed tomography (CT) evaluation of the right-side structures can help predict upfront left-sided access.³

Anatomical Suitability for TTVR With EVOQUE

Cardiac CT angiography is essential for TTVR planning. Analysis starts with assessment of the retention mechanisms that combine annular and ventricular oversizing, leaflet integrity, and the height of the papillary muscles. The EVOQUE system comes in four sizes (44 mm, 48 mm, 52 mm, and 56 mm) and can treat annular perimeters between 114 mm and 169 mm. After determining that the anatomy offers adequate retention mechanisms for EVOQUE TTVR, the second step involves assessing the suitability of the working room length in the right cardiac chambers and the IVC–RA–RV complex. The EVOQUE TTVR system requires a combination of factors, including a favorable trajectory, position, and depth of the capsule marker band below the TVA. The overall working length of the device is 90 mm from the inflexion point to the tip of the nose cone and 78 mm from the inflexion point to the capsule edge (Figure 1). Therefore, a total (RA + RV) working length ≥100 mm is required for TF valve delivery. Ideally, the capsule marker band is positioned between systolic and diastolic leaflet excursion to allow the anchors to peak and flip 90 degrees without entrapment in the subvalvular apparatus. The optimal depth of the capsule therefore takes into consideration the leaflet length; the longer the leaflets, the deeper the capsule needs to be. It also takes into consideration the presence and the proximity of tall papillary muscles, which can interact and be entrapped by the anchors. Such entrapment can lead to difficulty mobilizing the device during deployment and may result in prosthesis tilting or embolization after release. After entry into the RV, capsule marker band depth is affected not only by the height of the RA relative to the center of the TVA, but also by the distance between the IVC–RA junction to the TVA and the angle between the IVC and the TVA; an obtuse angle may shrink the working length. Ideally, the trajectory of the delivery system is perpendicular to the native tricuspid annulus. It is notably influenced by the anatomical offset between the IVC and the TVA. This can be measured by CT, though it only represents the best-case scenario. Prediction of the actual catheter-to-tricuspid offset is another step toward better procedural planning but is challenging due to the inability to determine compliance of anatomical structures.

Figure 1.

Left panel: The overall working length of the EVOQUE delivery device is 78 mm from the inflexion point to the capsule and 90 mm from the inflexion point to the tip of the nose cone. Right panel: The minimum working length to accommodate the EVOQUE delivery device is an RA >50 mm and an overall working length of RA and RV >100 cm. However, other factors affect the capsule position from the TV annulus, including the IVC–TVA offset and the EV distance from the TVA.

Abbreviations: EV, Eustachian valve; IVC, inferior vena cava; RA, right atrium; RV, right ventricle; TV, tricuspid valve; TVA, tricuspid valve annulus.

The secondary flex knob of the valve delivery system can move the device laterally and help overcome some of the IVC–TVA offset. The current iteration of the delivery catheter lacks the ability to gain RA height, and the depth knob can only add ventricular depth.

Troubleshooting Potential Anatomical Challenges With TTVR

Anatomical challenges arise mostly from a combination of inadequate (typically too-short) close proximity of IVC to TVA, RA–RV working length, and/or significant IVC tricuspid offset. Notably, the EVOQUE device cannot be recaptured once the anchors peek. This makes CT planning and bailout strategies very important.

The capsule length of the EVOQUE valve is 78 cm from the capsule marker to the proximal bend and 90 cm from the tip of the nose cone to the proximal bend (Figure 1). A systolic RA height of 60 mm to 100 mm is generally considered favorable, as it allows the capsule to achieve favorable RV depth for deployment. In the cases where the CT analysis predicts a potential for bailout due to limited working room or significant offset, an alternative access can include a left femoral or a transjugular (TJ) access.

Shallow RA height will likely lead to deep position of the capsule in the RV that can cause chordal entrapment of the anchors and suboptimal trajectory of the capsule, which is difficult to correct.

Maneuvers to gain height in the RA include gentle advancement of the Safari wire in the RV with care taken to observe the motion of the wire to avoid undue pressure on the RV apex. This can help raise the valve in the RA and thereby provide shallower RV depth. This maneuver has a modest gain in height at best. However, pushing the safari wire carries the risk of RV perforation and can affect the catheter trajectory, making deployment challenging.

Another maneuver to gain height is to add secondary flex to the system and rotate the entire system counterclockwise, which can translate atrially. This method may increase height by as much as 2 cm with maximal secondary flex (marker at 2 on the handle). Increasing the use of secondary flex will result in a more lateral position of the delivery device and limit the ability to adjust the anterior-posterior trajectory with primary flex.

Left femoral venous approach can provide approximately 1 cm of additional RA height³ and reduce the catheter to tricuspid offset to the minimum anatomical IVC tricuspid offset. Left femoral access has been recommended when RA height is <60 mm and the IVC–TVA offset is >20 mm.³

TJ access has recently been utilized in challenging anatomies, as it can provide extra cardiac working length (superior vena cava [SVC]), a less tortuous path to the RA, and more favorable coaxial alignment between the SVC and the center of the TVA.^4,5

TJ access offers additional options for TTVR. Before initiating TJ access for EVOQUE TTVR, the local heart team should establish adequate experience with TF deployment. In addition, planning how to position and adapt the interventional team, imager, and anesthesiologist within this new procedural environment is important. Unplanned conversion to jugular access can be challenging, particularly since tilting the table may be necessary to achieve correct coaxial alignment. Manipulation from the jugular approach involves inverted controls and different ergonomics.

The left TJ access typically allows for more height and reduced SVC tricuspid offset. However, this can be challenging in the presence of pacemaker leads and requires a careful assessment of potential lead adherence, notably to the innominate SVC junction.

Here we describe another strategy to overcome inadequate RA height during TF EVOQUE TTVR. Table 1 compares all maneuvers of gaining height with advantages and disadvantages, including the strategy described subsequently.

Table 1.

Maneuvers to gain right atrial height

Technique	Advantage	Disadvantage
Wire manipulation (push in RV)	Simple and reversible	RV apex injury/perforation. Limited value (height gain).
Secondary flex and counterclockwise motion of the EVOQUE delivery device	Simple and reversible	If excessive secondary flex is introduced, the primary flex will shift to a septal-lateral direction, which may complicate the correction of the anteroposterior trajectory.
Left femoral access	Mildly challenging if this is secondary access due to bilateral large-bore access increasing bleeding risk	Bilateral large-bore access unless left is chosen as primary access. More lateral position upon entry of RA. Large EV may prevent the EVOQUE valve from coaxial entry into RA.
TJ	Can overcome anatomical challenges of TF access—inadequate implant depth, IVC–TVA offset, large EV, and tortuous femoral vein and IVC	Room set up and positioning of interventional cardiologist, imager, and anesthesiologist. Manipulation from the jugular approach involves inverted controls and different ergonomics. Interaction with cardiac implantable electronic device leads. Incompatibility with most radiation protection systems leading to excessive radiation exposure.
Anterior tilted deployment	Bailout strategy when above TF techniques not helpful and anatomical requirements are met	Anatomical requirements (not applicable to all).

Abbreviations: EV, Eustachian valve; IVC, inferior vena cava; RA, right atrium; RV, right ventricle; TF, transfemoral; TJ, transjugular; TVA, tricuspid valve annulus.

Case Report

A 76-year-old patient with previous mechanical aortic valve replacement, permanent atrial fibrillation, chronic heart failure with preserved ejection fraction, chronic kidney disease, and a pacemaker presented with torrential tricuspid regurgitation despite maximal medical therapy with dyspnea and chronic edema (Figure 2). Her anatomy was felt to be favorable for EVOQUE TTVR with a 52-mm valve. CT analysis predicted favorable TF deployment with no significant procedural concerns, and TJ analysis was not performed. The patient had large RA and RV, with adequate working room of 61 mm in the RA and a favorable IVC–TVA offset. Her IVC centerline to TV centerline was 32 mm. She had a prominent Eustachian valve (EV) and EV–TVA distance of 24.6 mm (Figure 3).

Figure 2.

Left panel: TEE images. (a) RV inflow view. Posterior (P) and anterior (A) leaflets visible. This also shows a prominently long Eustachian valve (∗). (b) RV outflow view. Septal (S) and anterior (A) leaflets visible. (c and d) Color demonstrating torrential tricuspid regurgitation. Right panel: (e and f) CT cardiac angiography with measurements of the TVA. (g and h) CT overlay images generated using 3Mensio (Pie Medical imaging, Netherlands) showing the relationship of IVC and TV annulus in (g) coplanar view and (h) en face view showing there is overlap of the IVC and TV annulus, which is predictive of a favorable TTVR anatomy for right-sided femoral approach.

Abbreviations: CT, computed tomography; EV, Eustachian valve; IVC, inferior vena cava; RV, right ventricle; TEE, transesophageal echocardiography; TTVR, transcatheter tricuspid valve replacement; TV, tricuspid valve; TVA, tricuspid valve annulus.

Figure 3.

(a–c) CT cardiac angiography with measurements of the RV and RA in diastole and systole. Favorable RA height (>60 mm) and RV working room to accommodate the EVOQUE capsule. (d) Three-dimensional reconstruction reveals a prominent EV and distance to the TVA of 24.6 mm. In our cases, we have observed that EV–TVA distance <25 mm would favor a left femoral approach. (e) IVC centerline to TVA distance of 31.9 mm. In our experience, centerline IVC–TVA distance of <40 mm could potentially lead to inadequate working room length, and we favor a left-sided approach. In this case, despite a large RA height, we were unable to gain adequate RA height from the right- and left-sided approach.

Abbreviations: CT, computed tomography; EV, Eustachian valve; IVC, inferior vena cava; RA, right atrium; RV, right ventricle; TVA, tricuspid valve annulus.

After informed consent, the patient's TTVR was attempted from a right femoral approach, and a 3D Verisight intracardiac echo (ICE) (Philips, Netherlands) probe was advanced from the left femoral vein using a 12 Fr sheath due to challenging transesophageal echocardiography imaging from the mechanical aortic valve replacement. The capsule of the valve was too deep in the RV. Despite gentle manipulation of the safari wire and addition of secondary flex with counterclockwise rotation of the shaft, the capsule was still too deep in the RV and well past the TV leaflet coaptation. We then changed to a left femoral approach to gain RA height. Despite this, we were still deep in the RV with the capsule marker at 2.3 cm from the systolic coaptation (Figure 4). We then performed the anterior tilted deployment of the valve as described subsequently with successful deployment of the 52 mm EVOQUE valve.

Figure 4.

Left panel top image: 3D intracardiac image and CT simulation demonstrating inadequate right atrial height and a deep capsule position. CT predicted adequate right atrial height of >60 mm. However, the large EV prevented adequate right atrial height and the capsule was too deep. Multiple maneuvers to gain height were insufficient from the right femoral approach, and we converted to a left femoral venous approach. Despite the left femoral approach, the capsule was still deep in the RV at 3.3 cm from the TV annulus and 2.3 cm from the systolic coaptation plane. Left panel bottom image: CT simulation demonstrating the position of the capsule in relation to the EV (∗) and the TV systolic coaptation. Right image: Capsule deep in the RV. The white interrupted line represents the approximate plane of the TV annulus.

Abbreviations: A, anterior leaflet; CT, computed tomography; EV, Eustachian valve; P, posterior leaflet; RV, right ventricle; TV, tricuspid valve.

Anterior Tilted Deployment of the EVOQUE Valve

When all maneuvers to gain height from a femoral approach have been exhausted, the anterior tilted deployment of the EVOQUE system can be attempted. After coaxial positioning of the valve across the TVA is obtained, this method involves retraction of the delivery system posteriorly with a slow removal of the primary flex on the device, which will cause a pronounced posterior-to-anterior (PA) trajectory. This maneuver allows the delivery catheter to use an off-axis, anteriorly tilted orientation, providing longer ventricular depth into the RV outflow tract (RVOT). As the ventricular expansion progresses and the ventricular position of the valve shrinks, the operator can reposition the delivery system into a more coaxial position, perpendicular to the annulus. Care must be taken not to pin a potentially long anterior leaflet or scoop a high posterior papillary muscle with the anchors while the delivery sheath is still tilted anteriorly.

Anatomical Requirements for the Anterior Tilted Deployment of the EVOQUE Valve

This maneuver can be attempted provided anatomical requirements (Figure 5) are met:

• •The capsule can be positioned centrally and coaxially to the TV annular plane with minimal difficulty.
• •Capsule edge is <35 mm below the TV leaflet hinge points (Figure 5). This is the expected change in device height, measured from anchor tips to loading tabs, from crimped length to final release. Depending on the valve size, the crimped length of the EVOQUE valve frame is between 51 mm and 54 mm. At final release, the distance from the valve loading tabs to the flipped anchor tips is 17 mm (a change of 35 mm). If capsule edge is >35 mm below annulus, the flipped anchor tips will not be at the TV hinge points to securely anchor the valve.

Figure 5.

Anatomical requirement for anterior tilted deployment of EVOQUE valve. The crimped valve length from the loading tabs to the anchor tips is between 51 mm and 54 mm based on the valve size. At final release, the distance from the loading tabs to the flipped anchor tips is 17 mm. If the capsule edge is <35 mm below the annulus, the anchors will have adequate room to flip to the TV hinge points by final release without chordal entrapment.

Abbreviation: TV, tricuspid valve.

However, this maneuver should not be attempted in the following instances:

• •There is significant anterior leaflet tethering >15 mm (this is distance of the anterior leaflet tip to TVA in systole).
• •The posterior papillary muscle is higher than the capsule edge. This will prevent the anchor tabs from capturing the posterior leaflets.
• •More than 1.25 turn of secondary flex knob is required to correct the septal lateral trajectory. (Ideally the capsule is central in the septal lateral position.)
• •The capsule edge is >35 mm below the TV leaflet hinge points. The anchor tips will not reach the TV leaflet hinge point, which will prevent stable anchoring of the EVOQUE valve at final deployment.

Procedural Steps of the Anterior Tilted Deployment of the EVOQUE Valve

These are the steps of the maneuver:

• •Confirm that the valve capsule can be flexed and unflexed and positioned centrally and coaxially with minimal difficulty. This is performed before creating capsule gap. Ensure the valve is central in the septal lateral plane.
• •Using 3D multiplanar reconstruction on transesophageal echocardiography or ICE, confirm that the capsule is <35 mm below the TV hinge points.
• •If secondary flex and the counterclockwise technique were previously used to gain height, ensure that the secondary flex is reset to under 1.25 turns.
• •Release the primary flex to create a P-A trajectory into the RVOT. The Safari wire pressure and position should be maintained before releasing flex. Centralize the valve by retracting the entire system posterior (Figures 6 and 7).
• •While maintaining the PA trajectory and central position, the anchors are progressively exposed to 90 degrees (Figure 8).
• •Progressively withdraw the capsule to expose the valve anchors to initiate ventricular flip while simultaneously adding primary flex to correct the PA trajectory to become coaxial to the TV annular plane (Figure 9). Ensure the anchors are positioned to capture or have captured the leaflets. At this stage, the valve anchors will be at the level of the leaflet excursion and continue deploying per Instructions for Use (IFU).⁶
• •Once ventricular expansion is complete, adjust height and trajectory as needed by the IFU (Figure 10).⁶
• •Proceed with final atrial expansion for complete release of the valve (Figure 11).

Figure 6.

Left image: ICE showing the PA trajectory with the posterior aspect of the capsule edge just beneath the systolic coaptation plane. Right image: Capsule gap created with a pronounced PA trajectory to gain RA height. The white interrupted line represents the approximate plane of the TV annulus.

Abbreviations: ICE, intracardiac echo; PA, posterior-to-anterior; RA, right atrium; TV, tricuspid valve.

Figure 7.

Left image: ICE multiplanar reconstruction images. The anchors are peeking out of the capsule with a pronounced anterior trajectory and the tip of the capsule at the anterior septal commissure in the RVOT. Right image: The entire system is retracted posteriorly to avoid chordal entanglement while maintaining the anterior trajectory.

Abbreviations: A, anterior; ICE, intracardiac echo; L, lateral; P, posterior; RVOT, right ventricle outflow tract; S, septal.

Figure 8.

Progressive exposure of the anchors maintaining the anterior trajectory from 10 to 90 degrees while adding primary flex to correct the anterior trajectory and keeping posterior anchors at proper height to encourage leaflet capture and minimize possible entaglement with sub valve structures. The valve frame shortens as more anchors are exposed. The white interrupted line represents the approximate plane of the TV annulus.

Abbreviation: TV, tricuspid valve.

Figure 9.

Top panel: Progressive exposure of the anchors and ventricular flip of the anchors while simultaneously adding primary flex to correct the anterior trajectory and become coaxial to the TV annular plane. The white interrupted line represents the approximate plane of the TV annulus. Bottom panel: ICE multiplanar reconstruction images demonstrating the progressive ventricular flip of the EVOQUE anchors.

Abbreviation: ICE, intracardiac echo; TV, tricuspid valve.

Figure 10.

Left image: Ventricular expansion of the EVOQUE frame demonstrating engagement of the anchors evenly beneath the anterior, posterior, septal, and lateral portions of the TV annulus. Right image: Ventricular expansion of the EVOQUE frame. White interrupted line represents the approximate plane of the TV annulus. There is a mild anterior-to-posterior trajectory, which was corrected by the final release.

Abbreviation: TV, tricuspid valve.

Figure 11.

Left image: ICE image of the valve deployed. Right image: Fluoroscopy of the valve deployed. The white interrupted line represents the approximate plane of the TV annulus.

Abbreviation: ICE, intracardiac echo; TV, tricuspid valve.

Once the valve was released, the capsule was withdrawn back to the RA. The capsule was recaptured in the RA, and the entire system was withdrawn from the patient. Bilateral femoral hemostasis was achieved using a Perclose suture (Abbott Vascular, Menlo Park, California). Echocardiography revealed excellent valve function without central or paravalvular regurgitation. The patient was resumed on her anticoagulation and discharged home 2 days after the procedure.

Conclusion

EVOQUE TTVR is gaining rapid commercial adoption. The right-sided cardiac structures demonstrate significant variability. RA height, RV length perpendicular to the TVA, IVC–TVA distance, and IVC–TVA offset all influence procedural success. Right femoral approach is the most common access site used in 89% of patients in the TRISCEND II trial.² However, left femoral approach may be required in patients with inadequate RA height or large IVC–TVA offset.³ In our commercial experience, we have observed that the EV to TVA distance <25 mm and centerline IVC–TVA distance of <40 mm can be predictive of inadequate working room length during deployment, even in patients with large RA–RV dimension as described in our case. Techniques that can be used to overcome inadequate implant depth include wire manipulation, addition of secondary flex with counterclockwise rotation of device, left femoral approach, and TJ approach (Table 1). Our case highlights a new technique to overcome inadequate working length despite left femoral approach.

The anterior tilted deployment of the EVOQUE valve described herein can overcome deep capsule location in the RV. This maneuver allows the delivery catheter to use an off-axis, anterior tilt, thereby pulling the flexion of the catheter into the IVC and negating the limitation of RA height or IVC–TVA distance. It may be used in cases that fit certain anatomical criteria. The EVOQUE valve is not designed for recapture once the anchors are exposed; hence, if an RVOT deployment technique is attempted, a minor capsule separation may be created at the intended depth before the anchors are exposed. This technique may be attempted from either femoral approach and adds to the armamentarium of maneuvers (Table 1) that may be useful for successful TF valve deployment before abandoning the femoral approach.

Ethics Statement

This case report was carried out in accordance with the appropriate ethical guidelines.

Funding

The authors have no funding to report.

Disclosure Statement

Puvi Seshiah served as the proctor and consultant for Edwards; and he served as the subinvestigator for TRISCEND II trial. Santiago Gracia served as the proctor and consultant for Edwards; and he served as the principal investigator for TRISCEND II trial. Richard Bae and Nadia El Hangouche served as the proctors and consultants for Edwards.

The other authors had no conflicts to declare.