First-in-Human Use of a Novel Dual-Mechanism Transcatheter Tricuspid Repair Device

Abstract

Background

Transcatheter tricuspid valve intervention offers an alternative to surgery in high-risk patients with severe symptomatic tricuspid regurgitation (TR).

First-in-Human/Early Reports Summary

We report the first-in-human use of a novel transcatheter tricuspid valve repair device (Versa Vascular) that stabilizes annular dilation and induces regurgitant orifice sealing. The patient, an 85-year-old woman with symptomatic severe isolated functional TR, was considered high risk for open surgery, with unsuitable anatomy for other transcatheter-based options.

Discussion

As transcatheter tricuspid valve intervention evolves, devices must balance clinical outcomes and procedural versatility. Multimodal mechanisms of action that reduce TR across varied anatomies while preserving procedural safety and simplicity are essential. This technology shows promise with ease of use and reproducible results.

Novelty

The Versa Vascular system limited annular dilatation and reduced TR severity without affecting right ventricular function.

Take-Home Message

This first-in-human experience demonstrated safe implantation of a novel transcatheter repair device, with sustained TR reduction and improved functional status at 90 days.

Graphical Abstract

Tricuspid regurgitation (TR) is a highly prevalent valvular disorder associated with adverse outcomes, particularly among elderly patients.1, 2, 3, 4, 5 In this population, isolated tricuspid valve surgery is often overlooked, leading to continued disease progression and worsening heart failure symptoms.⁶ In recent years, several transcatheter technologies have emerged as promising alternatives to surgery. Transcatheter tricuspid edge-to-edge repair (T-TEER) has demonstrated a favorable safety profile and procedural simplicity; however, its clinical utility is limited by anatomical limitations and suboptimal TR reduction in many patients.⁷ Transcatheter tricuspid valve replacement (TTVR) achieves more complete TR reduction, but it is associated with higher postprocedural mortality and pacemaker implantation rates, as well as prosthesis-related complications such as thrombosis, degeneration, and endocarditis. To date, there is a need for the development of new therapeutic tools that combine the procedural safety of T-TEER with the superior reproducibility and TR reduction of TTVR. In this report, we present the first-in-human use of a novel transcatheter tricuspid repair system designed to limit the progression of annular dilation and modulate regurgitant flow (Versa Vascular).

Take-Home Messages

• •In this first-in-human clinical experience, implantation of a novel transcatheter repair device (Versa Vascular) was safe and led to sustained reduction in tricuspid regurgitation and improved functional status at 90 days.
• •This technology displays a multimodal mechanism of action, limiting annular dilatation and reducing TR severity while avoiding interference with right ventricular function.

Case Summary

An 85-year-old woman with a history of chronic atrial fibrillation presented with decompensated right-sided heart failure due to torrential functional TR secondary to severe annular tricuspid dilatation. Despite optimal medical therapy including high doses of diuretics, she remained severely symptomatic (NYHA functional class III) with signs of right heart failure.

Transthoracic echocardiography demonstrated torrential TR, with marked dilatation of the right heart chambers (basal right ventricular end-diastolic diameter: 67 mm, right atrial volume: 247 mL), right ventricular (RV) dysfunction (tricuspid annular plane systolic excursion: 1.3 cm, tissue Doppler imaging S′: 8.2 cm/s, RV fractional area change: 36%, RV outflow tract velocity-time integral: 7.7 cm), inferior vena cava dilation (diameter: 3.1 cm), and systolic flow reversal in the hepatic veins. Left ventricular ejection fraction was preserved at 51%, and no significant left-sided valvular disease was present. Severe septal leaflet tethering was observed. Transesophageal echocardiography (TEE) revealed a quadrileaflet tricuspid valve anatomy, and computed tomography (CT) showed a tricuspid annular perimeter of 152 mm, with annular diameters of 43 and 52 mm.

The heart team assessed the patient as being at high risk for open heart surgery (TRI-SCORE = 8/12).⁸ The anatomy was considered unsuitable for other transcatheter tricuspid valve intervention (TTVI) options using currently available devices. Consequently, the patient was evaluated for treatment with the transcatheter Versa Vascular system.

The Versa Vascular implant is a tricuspid valve repair device delivered percutaneously through a 26-F delivery catheter. The implant features a conformable nitinol frame that adapts to the anatomy of the right atrium and contains small barbs to anchor the implant in the atrial tissue. The frame is covered with a textile atrial skirt ingrowth matrix that aims to limit annular dilation with endothelization (as seen in chronic animal studies). A 22 mm–diameter disk is centrally located to reduce regurgitant flow (Figure 1), leaving a geometric orifice area of >8 cm², which is comparable to or greater than that of commercially available replacement devices. The dual mechanism is intended to limit annular dilation and reduce TR severity. The delivery system allows for the precise delivery, expansion, and repositioning of the devices multiple times before final release. Once released, the current generation of the device can not be repositioned or retrieved.

Figure 1.

Versa Vascular Implant Device

(A) Outflow/ventricular view and (B) inflow/atrial view.

The right common femoral vein was accessed and preclosed using standard vascular closure devices (Abbott Vascular). A 26-F DrySeal Flex introducer sheath (Gore) was positioned in the right atrium. The Versa Vascular system was introduced into the right atrium and aligned coaxially and coplanar with the tricuspid annulus, guided by three-dimensional multiplanar reconstruction TEE. The implant was unsheathed and expanded right above the annulus until a stable position was achieved, and the barbs were fully engaged with the anatomy (Figure 2). After device stability and TR reduction were confirmed via three-dimensional multiplanar reconstruction TEE and fluoroscopy, the device was released, and the delivery catheter was removed from the patient.

Figure 2.

Intraprocedural Fluoroscopic Images

Fluoroscopic views of the delivery catheter and implant throughout the procedure: (A) before unsheathing, (B) after unsheathing, and (C) at full expansion.

Complete hemostasis of the access site was documented after delivery sheath removal. Assessing residual flow after tricuspid repair is challenging given the complex flow dynamics. Final TEE showed a reduction of the TR from torrential to moderate, with stable positioning of the device (Figures 3 and 4). Fluoroscopic and follow-up CT images confirmed the stability of the device, without any tilting movement (Figure 5).

Figure 3.

Echocardiography Before and After Implant Procedure

TTE with color Doppler (A) at screening and (B) at 90-day follow-up∗ showing septal TR jet. TEE with color Doppler (C) before and (D) after implantation. ∗TTE images (panels A and B) with the same Nyquist limit before and after implantation were not available. TEE = transesophageal echocardiography; TR = tricuspid regurgitation; TTE = transthoracic echocardiography.

Figure 4.

Transthoracic Echocardiography After Device Implantation

TTE after device implantation in (A) diastolic phase with leaflets open and (B) systolic phase. (C) With three-dimensional multiplanar reconstruction.

Figure 5.

Fluoroscopy at End of Procedure and Follow-Up CT

(A) Fluoroscopic view of the implant after release. (B and C) CT at 90 days postoperatively. CT = computed tomography.

The patient was discharged 7 days after the procedure in an improved medical condition, and the guidance of anticoagulation of for least 6 months was followed. At 90-day follow-up, there was an improvement in NYHA status to class II, with good device anchoring confirmed on both transthoracic echocardiography and CT (Figure 5) and a mean gradient of 4 mm Hg. The two-dimensional vena contracta width of the TR jet was reduced from 2.1 cm at baseline to 1.2 cm at the 90-day follow-up (∼45% reduction). After device implantation, the central occluder effectively reduced the central jet, with a remaining but smaller residual leak surrounding the device.

Novelty of the Submission

The first-in-human implantation of this novel repair technology demonstrated the feasibility of the Versa Vascular device at 90-day follow-up. This technology displays a multimodal mechanism of action, limiting annular dilatation and reducing TR severity while avoiding interference with right ventricular function.

Future Directions

As the field of TTVI continues to evolve, future technologies must address the complex interplay between clinical outcomes and procedural versatility. There is a growing need for devices that go beyond the current repair-versus-replacement paradigms and instead offer multimodal mechanisms of action simultaneously. The ideal next-generation therapies should enhance TR reduction across a broader range of anatomies while maintaining the favorable safety profile of T-TEER. Equally important is the preservation of procedural simplicity and reproducibility, ensuring that these solutions can be adopted widely across diverse clinical settings. The next-generation Versa technology promises to achieve this balance by combining ease of use, procedural safety, and reproducible technical results. Additional sizes and shapes to accommodate the irregular shape of regurgitant orifices will increase the patient eligibility, as will testing and any required modifications to enable compatibility with existing pacemaker leads and future implantation of leadless permanent pacemakers.

Conclusions

In this first-in-human clinical experience, the implantation of a novel transcatheter repair device was safe and resulted in a sustainable reduction of the TR and improvement in functional status at 90 days.

Funding Support and Author Disclosures

Support for this work was received from Versa Vascular Inc (Santa Cruz, California). Dr Granada is a cofounder of Versa Vascular Inc and coinventor of the Versa Vascular device. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.