Interventional Tricuspid Valve Replacement: A Structured Sequence of Procedures

Summary

We describe the implantation of the transcatheter tricuspid valve replacement system (TTVR) in patients with severe tricuspid regurgitation. The transcatheter system is the first FDA-approved, commercially available transcatheter tricuspid replacement therapy with percutaneous transfemoral vein access. Under continuous transesophageal echocardiographic guidance, the device is deployed within the native tricuspid valve.

Abstract

The EVOQUE valve system is the first approved tricuspid valve replacement system developed specifically for the percutaneous implantation of a biological tricuspid valve in patients diagnosed with symptomatic severe tricuspid regurgitation (TR). The implantation procedure is performed through the introduction and advancement of the valve delivery system via the femoral vein. The prosthetic valve consists of a Nitinol frame with a valve made from bovine pericardium. The entire implantation procedure is performed completely percutaneously. Each step of valve positioning, deployment, and implantation is performed while the patient is under general anesthesia. The procedure is carried out under close observation and precise steering using continuous guidance with transesophageal echocardiography (TEE). This protocol presents a comprehensive and detailed step-by-step approach to the interventional endovascular implantation of the EVOQUE tricuspid bioprosthesis under TOE guidance. The procedure has been demonstrated to be both safe and efficient, with most patients achieving complete resolution of tricuspid regurgitation.

Introduction

Severe tricuspid regurgitation (TR) is shown to be associated with disabling symptoms and an increased risk of death¹. TR can be classified into three etiological types. Primary TR is caused by intrinsic abnormalities of the tricuspid valve, such as Epstein’s anomaly, carcinoid syndrome, or endocarditis. Secondary TR, which is the most common form, results from annular dilatation secondary to alterations in right heart anatomy. Tertiary TR arises from tricuspid regurgitation induced by cardiac electrical devices, either through mechanical interference² or pacing-related ventricular remodelling³.

Isolated tricuspid valve surgery is performed infrequently and is associated with high rates of operative death and complications. Patients are usually of advanced age, above 80, and therapy is limited to surgery, with a mortality between 8% and 27% depending on the comorbidities of the patients and the centre's experience^4,5,6,7. The incidence of TR is high, with >300,000 patients in Europe and >200,000 in the US⁸ with only a limited number of surgically treated patients between 8,000 and 10,000 in the US⁹. There are no exact numbers of performed surgeries in Europe. Therefore, percutaneous procedures have gained significant attention in the last decade. There were several developments for the percutaneous repair of TR. The currently most frequently used technique is the transcutaneous edge-to-edge repair technique (TEER) by the Tricuspid-clip system (T-TEER).

The anatomic constraints for Transcutaneous Tricuspid Valve Replacement (TTVR) are primarily related to the ability to position the device within the annular plane and the anchoring mechanism. Compared to the T-TEER technique, large coaptation gaps, complex leaflet morphologies, markedly thickened or immobile leaflets, and CIED-related TR can also be treated by TTVR. For TTVR devices, significant determinants of feasibility are the size of the current devices compared to the tricuspid annulus, as well as the ability to steer the device to obtain a coaxial implantation trajectory, in large part determined by the size of the implant device and available right heart space.

First register trials with these T-TEER devices showed very good safety and efficacy. Within the randomized TRILUMINATE trial (Tricuspid clipping vs medical therapy only), there were no in-hospital deaths; patients in the intervention group had a significant increase in quality-of-life and reduction in tricuspid regurgitation. Nevertheless, after TEER, there were 50% of patients with a residual, moderate, severe, massive, or torrential TR after 30 days, showing that the edge-to-edge strategy is not able to reach a result consistent with or better than that of surgery¹⁰. Also, other interventional strategies like the interventional annuloplasty with a band or a spacer device (an interventional applicable spacer technology within the gap of the leaflets of the tricuspid valve) could not show complete reversal of the TR.

Taking into consideration these limitations of the current available percutaneous devices and the fact that not every patient is suitable for these repair techniques together with the fact that surgery has a significant periprocedural mortality risk and that the cohort of TR patients is usually older and has a per se high risk for surgery or is inoperable due to concomitant diseases underlines the need for a development of a low risk transcatheter valve replacement system.

With the Tricuspid replacement valve system demonstrated in this protocol, we provide a complete percutaneous implantation of a new valve (in the tricuspid valve) that results usually without relevant regurgitation. The most common patient type treated is patients with secondary TR, but other aetiologies can also be treated with the system. First randomized data from the TRISCEND II Trial showed the safety and efficacy of the TTVR compared to medical therapy only. Patients in the implantation arm of the trial experienced a more than 2-fold greater likelihood for clinical benefit, showing a significantly better composite safety and efficacy endpoint with a hierarchical test win ratio of 2.02¹¹.

Echocardiography and computed tomography (CT) are key imaging modalities to ensure procedural success. This procedure is performed percutaneously in a minimal-invasive fashion in a standard cardiac catheterization laboratory under general anesthesia using usually fluoroscopy, TOE guidance, and physiological monitoring.

Protocol

The filming of the procedure was approved by the patient as well as all involved team members and confirmed by the ethics committee of the University Hospital Jena, Jena, Germany.

1. Procedural planning

NOTE: Patients should be in a compensated, euvolemic state before intervention. This status should be verified by achieving the lowest NT-proBNP level. Patient’s weight should be documented.

1. Examination methods required.
   1. Begin pre-procedural planning with a comprehensive imaging work-up, including transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and an ECG-gated, contrast-enhanced CT scan.
   2. Measure the tricuspid annulus dimensions using appropriate imaging modalities.
   3. Evaluate the morphology of the tricuspid leaflets and chordal structures.
   4. Identify the presence of any intracardiac leads and assess their position relative to the valve apparatus. Determine the optimal fluoroscopic and echocardiographic implantation angle. Verify adequate transesophageal echocardiography image quality before proceeding.
   5. Assess left ventricular and right ventricular function using echocardiography and other relevant imaging methods. Perform right heart catheterization while the patient is in a compensated, euvolemic state.
   6. Measure and document pulmonary artery pressure (PAP), pulmonary capillary wedge pressure (PCWP), and pulmonary vascular resistance (PVR). Use these hemodynamic parameters to evaluate right heart function and pulmonary hemodynamics.

2. Procedural preparation

1. Physiological Monitoring
   1. Perform the procedure under general anesthesia with endotracheal intubation. Establish continuous invasive arterial blood pressure, electrocardiographic, peripheral oxygen saturation, and pulse monitoring.
   2. Establish central venous access for volume or medication administration.
2. Positioning of the patient
   1. Position the patient supine on the catheterization laboratory table.
   2. Place a pillow under the patient’s right shoulder if necessary to optimize TEE image acquisition. Position a rigid plate beneath the patient’s knees to serve as a stable base for the stabilizer table.
   3. Place the small table over the patient’s knees, sloping toward the midline, and secure the implant device within the stabilizer holder mounted onto the table.
3. Preparation of the Sterile Set
   1. Prepare a sterile set with the required materials and prepare the instrumentation table according to standard catheterization laboratory practice.
   2. Sterilize both femoral access sites and position sterile drapes over the patient, including the stabilizer table. Cover both femoral access sites with transparent foil plaster after draping.
   3. Prepare an additional large side table with sterile drapes for device preparation.

3. Venous Access

1. Access Site Location
   1. Select the right femoral vein as the preferred access site according to pre-procedural planning.
2. Ultrasound-Guided Puncture and Anesthesia
   1. Prepare a linear ultrasound probe with a sterile ultrasound cover and localize the femoral vein using ultrasound guidance.
   2. Administer subcutaneous anesthesia medication (e.g., Xylocaine 2%, 10–20 mL) under ultrasound observation.
3. Venous Access and Sheath Insertion
   1. Puncture the right femoral vein using ultrasound guidance.
   2. Advance the standard J-tip wire, packaged with the steerable sheath, into the right femoral vein. Introduce a steerable long sheath (8.5 Fr.) into the superior vena cava.

4. Placement of TEE Probe

1. Preparation
   1. Apply local anesthetic spray (e.g., Xylocaine spray) to the oropharyngeal region and insert a bite guard to protect the probe and the patient’s teeth. Apply glide gel to facilitate the smooth insertion of the probe.
2. Probe Placement
   1. Advance the TEE probe carefully into the mid-esophagus until cardiac structures are visualized on the echocardiographic screen. Use a laryngoscope if necessary to facilitate safe probe insertion.
3. Initial TEE Evaluation
   1. Begin with the mid-esophageal view at 0° to examine all chambers and rule out pericardial effusion.
   2. Evaluate right ventricular and left ventricular function, assess mitral regurgitation, and assess forward right ventricular stroke volume using RVOT velocity-time integral or 3D volumetric assessment.
   3. Assess and reconfirm tricuspid valve measurements (AP diameter, SL diameter, and circumference) within the intended landing zone using multiplanar reconstruction. Compare these measurements with CT scan measurements to ensure selection of the correct valve size.

5. Right Ventricular Access

1. Advancement into the Right Ventricle
   1. Introduce a standard 5 Fr pigtail catheter through the previously positioned steerable sheath and advance both into the right atrium.
   2. Visualize the mid-esophageal TEE view, flex the steerable sheath to approximately 70–90°, and rotate it toward the tricuspid valve orifice. Advance the pigtail catheter across the tricuspid valve into the right ventricle.
   3. Observe all manipulations continuously using TEE, especially transgastric biplane views. Ensure that the pigtail catheter is not entrapped between a papillary muscle or chordae tendineae, and position the catheter within the right ventricular apex.
   4. Proceed with preparation of the valve system after confirming femoral access and right ventricular positioning.
2. Introduction of the Stiff Wire
   1. Advance the designated extra-stiff wire through the pigtail catheter and position it in the right ventricular apex. Remove the pigtail catheter after confirming correct wire positioning.
   2. Verify by TEE that the extra-stiff wire lies freely within the right ventricular apex without interaction with subvalvular structures, avoiding entanglement in the anterior papillary muscle or chordae tendineae.
3. Sheath Removal
   1. Remove the pigtail catheter and gradually withdraw the steerable sheath from the right ventricle.
   2. Retroflex the sheath during withdrawal to minimize tension on the right ventricular wall. Use TEE to verify stable extra-stiff wire position in the right ventricular apex and use fluoroscopic guidance during complete removal of the sheath from the patient.
4. Anticoagulation
   1. Administer an intravenous heparin bolus of approximately 100 IU/kg body weight after positioning the wire in the right ventricular apex.
   2. Achieve an activated clotting time of 300–350 s and measure activated clotting time approximately 5 min after heparin administration and every 30 min thereafter.
   3. Administer additional heparin if the activated clotting time falls below 250 s.

6. Device Introduction

1. Preparation of the Femoral Vein
   1. Perform stepwise pre-dilatation of the femoral access site using the dedicated dilator set, starting with the smallest dilator and progressing to the middle and then the largest dilator (33 Fr). Leave each dilator in the vein for approximately 30 s to allow adaptation.
   2. Monitor stiff wire position using TEE and angiography during manipulation at the groin to maintain correct positioning.
2. Device Introduction
   1. Secure the stabilizer onto the stabilizer table or base and fix it firmly.
   2. Introduce the pre-prepared valve delivery system with the prepared valve into the patient and advance it over the stiff wire until the tip reaches the inferior vena cava–right atrium transition. Monitor the wire position continuously using TEE during advancement.
   3. Retract the delivery system to maintain position at the inferior vena cava–right atrium transition and fix the sheath into the stabilizer.
   4. Advance the device gently forward to cross the tricuspid valve while aligning the device perpendicular to the valve using the primary flex knob. Turn the primary flex knob gently while observing movements fluoroscopically and by TEE and pull the stiff wire gently during advancement.
   5. Confirm stable wire position in the right ventricular apex and monitor valve and delivery system movement continuously. After the nose cone crosses the tricuspid valve, secure the delivery system within the stabilizer and turn the flush port to the 2:00 o’clock position.
   6. Adjust the fluoroscopy C-arm to the optimal implant angle calculated pre-operatively from CT data. Use a right anterior oblique position in most cases.
3. Positioning of the Delivery System
   1. Center the device within the tricuspid annular plane with the trajectory toward the apex. Adjust septolateral alignment using the secondary flex knob and adjust the anterior–posterior direction using the retract knob.
   2. Monitor device position continuously using multiplanar reconstruction (MPR) TEE. Advance the nose cone below the valve coaptation line.
   3. Pull the wire to move the system forward until the wire loop reaches the nose cone to gain depth. Use the black depth knob if additional depth is required.
   4. Create a capsule gap of approximately 2 mm by turning the capsule knob in the release direction, then turn the capsule knob one-half to one full turn back in the closing direction for relaxation of the device.
   5. Assess device depth using TEE and use the capsule gap as a marker. Achieve the final target position when the capsule gap aligns with the native leaflet coaptation zone.

7. Valve Release

1. Reassess valve position using TEE and fluoroscopy after each manipulation of the delivery system. Confirm central septal-lateral and anterior-posterior positioning within the annulus and ensure a coaxial trajectory to the native valve annulus. Verify alignment using TEE-MPR and fluoroscopy.
   1. First Procedural Time-Out
      1. Confirm adequate system position, central annular positioning, and coaxial trajectory to the annulus.
      2. Attempt repositioning if any criterion is not met. Abort valve deployment if optimal alignment cannot be achieved despite repositioning.
2. Anchor Release to 45°
   1. Retract the capsule by turning the capsule knob until the anchors open to approximately 45°. Monitor anchor opening continuously using TEE and fluoroscopy.
   2. Rotate the capsule knob one-half to one full turn in the closing direction to allow passive relaxation of the device. Reassess position and reposition if required.
   3. Apply gentle pulling and use the dedicated knob if additional depth is required.
   4. For more septal positioning: Rotate the system away from the 2 o’clock position toward the 3 or 4 o’clock position or adjust using the secondary flex knob.
   5. Adjust anterior–posterior positioning using the retract knob. Consider changes in steering interaction after applying secondary flex.
3. Anchor Release to 90°
   1. Open the capsule further to 90° after confirming adequate position. Rotate the capsule knob one-half to one full turn in the closing direction to allow passive system relaxation.
   2. Perform a 360° spin in the MPR view to confirm that each anchor is engaged below the leaflets toward the hinge points. Correct trajectory, depth, and central position if required. Retract the nose cone to gain height.
4. Anchor Release to 135°
   1. Continue capsule retraction to 135° after confirming satisfactory anchor engagement at 90°. Rotate the capsule knob one-half to one full turn in the closing direction to allow passive system relaxation.
   2. Perform a 360° spin in the MPR view to confirm anchor engagement below the leaflets toward the hinge points. Correct trajectory, depth, and central position if required. Retract the nose cone to gain height.
5. Anchor Full Release and Ventricular Expansion
   1. Open the capsule until the anchors expand to nearly 180°. Confirm anchor engagement and valve position using a 360° MPR spin and confirm free movement of the native leaflets by TEE.
   2. Continue releasing the capsule knob until the marker band exits the capsule’s distal marker ring. Perform another 360° MPR spin to confirm correct position and anchor engagement.
6. Atrial Expansion and Final Release
   1. Move the valve into a more atrial position so that the anchors move under the hinge points of the leaflets. Pull back the wire and nose cone and use the depth knob if required to reduce depth.
   2. Confirm anchor contact with the leaflet hinge points at the annular plane using a 360° MPR spin. Perform controlled tilting maneuvers if alignment is not achieved in all quadrants.
   3. Adjust alignment using the retract knob, reduce primary or secondary flex, or rotate the device clockwise or counterclockwise as required. Select positioning maneuvers according to the degree of secondary flex applied.
   4. Rotate the blue release knob clockwise after confirming the correct depth and position. Verify coaxial valve position and correct anchor height at the annular plane using the MPR view.
   5. Pull back the nose cone into the middle of the valve using the taper tip slider. Turn the release knob completely to disconnect the valve from the delivery catheter.
   6. Perform a final TEE assessment to confirm stable valve position and function.

8. Removal of the Delivery System

1. Removal from the Right Ventricle
   1. Remove the delivery system under continuous TEE and fluoroscopic monitoring. Confirm that the nose cone is completely retracted.
   2. Gradually release secondary flex followed by primary flex while withdrawing the system. Verify central wire position under fluoroscopy and avoid contact between the valve and the delivery system or wire.
   3. Retract the system while returning secondary and primary flex to their starting positions to maintain a central position within the valve.
2. Explanting the Delivery System
   1. Rotate the blue release knob counterclockwise to close the inner capsule until the tapered tip is reached once the system is in the right atrium.
   2. Rotate the white capsule release knob counterclockwise to close the outer capsule. Remove all flex from the system and withdraw the delivery catheter from the patient.
3. Wire Removal
   1. Confirm central guidewire position within the valve using fluoroscopy and TEE.
   2. Advance a pigtail catheter over the wire and withdraw both to leave the valve in a smooth position.
4. Echocardiographic Control
   1. Perform a TEE evaluation to assess valve position and function. Check for intra- and paravalvular leakage, assess right and left ventricular function, evaluate mitral regurgitation, and exclude pericardial effusion.

9. Closure of the Access Site

1. Place a figure-of-eight stitch (Z-suture) using a size 0–2 USP suture distal and proximal to the wire entry site and secure with a tight knot to achieve hemostasis of the groin.
2. Use a suture device or a combination if required.
3. Apply an additional light compression bandage to the groin.
4. Complete the procedure.

10. Postinterventional Therapy

1. Administer heparin antagonization after access site closure if required.
2. Stop general anaesthesia and extubate the patient. Continue anticoagulation therapy for at least 6 months.
3. Establish monitoring for at least 24 h. Establish ECG monitoring for at least 72 h.
4. Perform follow-up ECG and transthoracic echocardiography.

Results

The tricuspid valve system was evaluated in a prospective nonrandomized, single-arm, multi-center trial-in US and Europe at 20 centers (TRISCEND study)¹². It included 176 patients with moderate to severe tricuspid regurgitation in a single arm. The first randomized study was TRISCEND II¹¹.

In TRISCEND, the majority of patients were elderly and highly symptomatic, with more than 75% in NYHA class III–IV. Tricuspid regurgitation was severe or greater in about 88%, including a substantial proportion with torrential TR. Device implantation was successful in 94% of patients. The high implantation rate demonstrates the technical possibility and reproducibility of the procedure. The 30day major adverse event rate was 18.6%, with a cardiovascular mortality of 1.7% compared to the predicted STS mortality score between 7.4–10% (repair vs replacement) and a severe bleeding rate of 16.9%. Cardiovascular death rate after 1 year was 9.1%. These findings indicate the acceptable safety of the procedure in high-risk and elderly patients. Heart failure hospitalizations were reduced to 74.9% within 12 months. Quality of life improved significantly, as measured by the KCCQ score, and NYHA Class improved, with 93.3% NYHA Class I–II after one year. In addition, the 6-min walk test increased significantly, as well as freedom from edema. Together, these results demonstrate a meaningful functional improvement and symptomatic relief following transcatheter valve replacement.

In the randomized TRISCEND II trial, patients were assigned in a 2:1 ratio to transcatheter valve replacement or medical therapy alone across 45 centers in the US and Germany. Patients were eligible if they were symptomatic and had at least severe tricuspid regurgitation. Patients with impaired right ventricular function and severe impaired renal function (eGFR<25 ml/min/ 1.73m²) or who had a reduced life expectancy of <12 months were excluded from the trial. Medication included a stable diuretic dose. A core laboratory reviewed initial echocardiograms before entry into the trial. Patients were at a mean age of 79.2 years, and 75.5% were women. The STS mortality score was high, with 6.7% for mitral valve repair and 9.7% for mitral valve replacement.

After 30 days, mortality was in the device group 3.2% vs 0% in the control group, 10.5% had severe bleeding events, and 15.8% vs 0% developed conduction abnormalities requiring pacemaker implantation. After 1 year, there were 11.6% death in the device group vs 10.5% in the control group, and 17.4% pacemaker implantations vs 2.3% in the control group.

At 1 year of follow-up, the win ratio of 2.02 favors valve replacement with EVOQUE. These results support the clinical superiority of transcatheter valve replacement compared with medical therapy alone. Patients in the device group showed an improvement in NYHA class, quality of life (KCCQ), and 6 min walk test. At least 72.6% in the device group had no residual TR after 1 year. The finding supports the sustained efficacy of transcatheter valve replacement in reducing tricuspid regurgitation.

Figure 1: Echocardiographic and Three-Dimensional Imaging of the EVOQUE Valve. (A) Transesophageal echocardiography image demonstrating torrential tricuspid regurgitation before implantation (arrow). (B) Transthoracic echocardiography images of the EVOQUE valve. Left: The EVOQUE valve (*) visualized on transthoracic echocardiography. Right: Diastolic frame of color Doppler interrogation. (C) Implanted EVOQUE valve with the atrial side oriented superiorly. (D) Three-dimensional reconstructed image of the implanted EVOQUE valve (*) viewed from the right atrium. Please click here to view a larger version of this figure.

Procedural Phase	Critical Step	Imaging Criteria
Pre-procedural planning	Annular sizing and trajectory planning	CT-derived annular dimensions; predefined RAO implant view; adequate RV size
RV access and wire positioning	Central apixal wire placement	Wire free in RV apex without chordal/papillary interaction (TEE transgastric view)
Initial positioning	Coaxial alignment in annular plane	Perpendicular trajectory to annulus (TEE-MPR + fluoroscopy)
Depth positioning	capsule gap at leaflet coaptation line	Capsule marker aligned with native hinge points (TEE-MPR)
45°–90° anchor release	Symmetric early anchor engagement	Anchors below leaflet insertion; no chordal interference
135°–180° release	Full anchor engagement in all quadrants	360° MPR confirmation of hinge-point capture
Final release	Stable annular alignment before detachment	Coaxial orientation maintained; free leaflet motion
Device removal	Central withdrawal without valve contact	Wire centered within valve frame (fluoroscopy + TEE)
Post-procedural monitoring	Rhythm and valve function assessment	No paravalvular leak; stable RV/LV function; no pericardial effusion

Table 1: Step-by-step guide to the valve replacement procedure. This table provides a step-by-step guide to the valve replacement procedure from the preprocedural to the procedural phase.

Discussion

The EVOQUE transcatheter tricuspid valve replacement system represents the first percutaneously implantable system for patients with symptomatic severe tricuspid regurgitation. These patients are typically older than 75 years, multimorbid, and at high risk of mortality for surgical valve repair. In contrast, transcatheter edge-to-edge repair has shown clinical improvements with a reduction of the tricuspid regurgitation, but often leaves patients with at least moderate TR. Therefore, the percutaneously implantable tricuspid valve offers a complete removal of the TR in most patients and can be a good alternative to edge-to-edge procedures.

From a procedural perspective, several steps are critical for successful implantation. Careful pre-procedural imaging using TEE and CT is mandatory to assess annular size, right ventricular and left ventricular function and dimensions, and the optimal fluoroscopic imaging. During the intervention, careful wire placement in the RV apex and continuous monitoring of the execution of each procedural step are crucial. Re-evaluation before each deployment stage, especially before final release, is an important safety element, as this represents the last opportunity to reposition or abort the procedure without harm.

The described trials of the Tricuspid system demonstrate a good clinical and functional success of the therapy, whereas mortality seems not to be affected. Nevertheless, there was a significant clinical improvement when using the EVOQUE transcatheter tricuspid valve replacement in addition to medical therapy versus medical therapy alone.

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Agilis NxTSheath 71 cm , 8.5F  (medium or large curl)	Abbott	G408321/ G408324	Crossing tricuspid valve
Evoque Application system	Edwards Lifesciences		Valve application
Evoque stabilizer, plate and base	Edwards Lifesciences		Stabilizer
Evoque Valve	Edwards Lifesciences		Valve - different sizes
Pigtail catheter Impulse 5 F	Boston Scientific	GTIN 08714729343639	Navigation in the right ventricle
Safari extra small wire	Boston Scientific	GTIN 08714729887614	exchange wire