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.
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Method Article
Interventional Tricuspid Valve Replacement: A Structured Sequence of Procedures
In This Article
Summary
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
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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.
- Examination methods required.
- Begin pre-procedural planning with a comprehensive imaging work-up, including transthoracic echocardiography (TTE), transesophageal ....
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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 great.......
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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 tricus.......
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Disclosures
The authors have no conflict of interest.
Acknowledgements
CT evaluation was performed by the manufacturer's team as a standard procedure. We appreciate the support of the manufacturer’s staff and thank the patient for allowing the case to be broadcast.
Special thanks to the patient who allowed us to broadcast the case.
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Materials
| 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 |
References
- Nath, J., Foster, E., Heidenreich, P. A. Impact of tricuspid regurgitation on long-term survival. J Am Coll Cardiol. 43 (3), 405-409 (2004).
- Addetia, K., Harb, S. C., Hahn, R. T., Kapadia, S., Lang, R. M. Cardiac Implantable Electronic Device Lead-Induced Tricuspid R....
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