A Peek at the Pipeline of Transcatheter Tricuspid Valve Replacement Systems

The race to develop transcatheter systems for tricuspid regurgitation (TR) continues, and early-stage report cards are in for several investigational devices.

Progress with transcatheter tricuspid valve replacement (TTVR) candidate devices Topaz, LuX-Valve Plus, VDyne, and Trisol for severe to torrential TR was shared at the EuroPCR meeting in Paris, continuing the notable flurry of transcatheter innovation in this space.

Despite this early enthusiasm, it has been widely acknowledged that tricuspid valve interventions have a long road ahead to reach real-world patients. The earliest devices to hit the market — the Evoque TTVR device and the TriClip transcatheter edge-to-edge repair device — are still finding their footing amid dispersal issues. Both of these systems are FDA approved for quality of life and health status improvement, but there is a lack of robust evidence on clinical benefit.

Here are the progress reports on candidates for tricuspid valve intervention featured at this year’s EuroPCR meeting.

Topaz

In the TRICURE first-in-human study, there were positive safety and effectiveness results at 30 days with the Topaz transfemoral TTVR device.

In 20 patients with severe symptomatic TR deemed not eligible for surgery, implant of the Topaz device resulted in a total major adverse event (MAE) rate of 35%, with three deaths (15%), three re-interventions (15%), and one heart failure hospitalization (5%). Notably, there were no instances of myocardial infarction, stroke, or need for permanent pacemaker attributed to the Topaz, reported Julien Dreyfus, MD, PhD, of Centre Cardiologique du Nord in Paris.

As for device success, 100% of patients achieved none or mild TR at 30 days. Moreover, symptoms were reduced down to New York Heart Association (NYHA) class I or II for 85% of Topaz recipients.

The TRICURE E.U. pivotal study and early feasibility study are ongoing to confirm the results. So far more than 60 procedures have been done with encouraging results, according to Dreyfus.

Topaz is designed with a rigid inner stent and soft outer stent. The device is anchored to the native leaflets and flexes with every heartbeat. In TRICURE, the average procedure lasted 35 minutes.

Dreyfus noted that 70% of the TRICURE cohort (average age 77, 90% women) had an NYHA functional class of III or worse; their predicted in-hospital mortality had been 17.6%.

LuX-Valve Plus

There were also promising safety and performance data with the LuX-Valve Plus, though pacemaker implants may be something to watch for with this transjugular TTVR device.

The TRINITY study showed that in patients with severe symptomatic TR at high risk for tricuspid valve surgery, the LuX-Valve Plus had a 14.8% MAE rate at 30 days that included two cardiovascular deaths (1.3%), one stroke (0.7%), six severe bleeds (4.0%), and 13 new pacemaker implants (8.7%).

The device met its 30-day performance goal (TR grade 2 or better without clinically significant paravalvular leak) in 95.7% of patients. NYHA class was successfully reduced to class I or II in 84.1%, reported Thomas Modine, MD, PhD, of CHU Bordeaux in France.

He said the LuX-Valve Plus features a non-radial force anchoring design, a self-adaptive braiding ring to reduce annular dilation, and a delivery system that facilitates precise valve release positioning. The device also has a large size option that makes it applicable to a wider range of anatomies.

Of note is the second-generation device’s design for implantation via the transjugular vein to reduce trauma from the TTVR procedure; the original LuX-Valve device had a transatrial approach.

Altogether, the full cohort of TRINITY included 149 patients with an average age of 77 years; about 66% were women. At baseline, 36.9% had torrential TR, 51.0% had massive TR, and 12.1% had severe TR.

Modine said that the LuX-Valve Plus continues to be investigated in clinical studies.

VDyne

Another system for transfemoral TTVR, the VDyne, similarly showed promise in a small early feasibility study that also saw pacemaker needs arise after device implant.

In 43 VDyne recipients with severe symptomatic TR, MAEs at 30 days included two instances of cardiovascular death (4.7%), one stroke (2.3%), two conversions to surgery (4.7%), and six cases of new pacemaker or cardiac implantable electronic device placement (13.9%).

At 30 days, TR was reduced to none/trace in 75% of patients, and mild in 21.4%. This improved further by 6 months, when 93.3% of patients had none/trace TR and 6.7% had mild TR, according to Jörg Kellermair, MD, of Kepler University Hospital Linz in Austria.

In addition, 85% of device recipients reached NYHA class I or II at 30 days, a figure that grew to 89% at 6 months.

Kellermair described the VDyne as having a shallow side delivery approach, an asymmetric D shape that conforms to native anatomy, a design for ventricular oversizing with barb-free anchoring, and a short profile. It was also designed with five available implant sizes (with three more sizes planned for the near future).

VDyne’s VISTA early feasibility study cohort had an average age over 77 years, and 72% were women. Of the participants, 31.7% had severe TR, 34.1% had massive TR, and 26.8% had torrential TR.

Trisol

Finally, TR was also improved to some degree with yet another TTVR system, this one having a single-leaflet design held by two commissures, in another early feasibility study.

Among 11 patients, 27% had none/trace TR at 30 days, and 55% had mild TR. At latest follow-up — the longest being 4 years in one patient — none/trace TR criteria were met by 38% and mild TR criteria by 54% (with 8% still having moderate TR), reported Isaac George, MD, of NewYork Presbyterian/Columbia University Medical Center in New York City.

Patient symptoms improved to NYHA class I or II in 82% at 30 days, reaching 91% at latest follow-up.

George noted that 16 patients have been enrolled to date in this study. Of the 11 included in the present report, 46% had severe TR, 15% had massive TR, and 39% had torrential TR.

He explained that the Trisol was designed with gradual leaflet closing for reduced right ventricular peak pressure gradients, along with a large orifice for better filling of the right ventricle. The design avoids the application of radial force by the device.

Disclosures

Dreyfus reported personal fees from Abbott and Edwards Lifesciences.

Modine disclosed consulting for Jenscare Scientific.

Kellermair reported personal fees from Abbott and Daiichi Sankyo.

George declared consulting relationships with Edwards Lifesciences, Medtronic, Boston Scientific, VDyne, and Trisol.