Imaging specialist Rebecca Hahn explores key details about the Evoque TTVR device

The valve greatly improved patient quality of life as well, with improved Kansas City Cardiomyopathy Questionnaire (KCCQ) scores by a mean of about 17 points.

TRISCEND II findings

The TRISCEND II trial randomized 400 patients with severe or greater tricuspid regurgitation. It compared outcomes between the Evoque TTVR system and optimal medical therapy (OMT). With a 2:1 randomization favoring the device, the trial evaluated complex safety and efficacy endpoints.

The patients were all very sick, many being classified with torrential regurgitation. The requirement to enter the trial was greater than or equal to severe regurgitation. Many had renal dysfunction, and almost all had atrial fibrillation. Biomarkers indicated liver congestion in most patients as well. 

"These were very sick patients and I think they came to us very late in the disease process," Hahn said.

The trial looked at a composite primary safety and effective endpoint that included all-cause mortality, the need for a right ventricular assist device (RVAD) or heart transplant, tricuspid valve intervention, annualized rate of heart failure hospitalization, KCCQ improvement, NYHA heart failure class improvement and improvements in the six-minute walk at one year. Patients will be followed out to five years.

The endpoints were compared to the control in a win ratio assessment, where TTVR had wins 62.1% compared to 30.7% in the OMT arm.

"The win ratio was 2.02, so it was highly favorable for the TTVR device. And in almost every single one of the seven parameters that were tested, the wins were higher for the transcatheter valve replacement patients. Almost all numbers were better in patients who received the valve replacement than those that were treated with optimal medical therapy," Hahn explained. "If you look at the Kaplan-Meier curves, there is indeed a difference at one year. And I'm really looking forward to the later follow-ups, because the trends are that the curves are separating."

There was a 12% mortality rate for TTVR and a 15% rate for the OMT group. But Hahn said that if rates are examined starting at the 30-day mark due to a slight upfront risk of a valve replacement, the curves are even more separated, landing at 9% vs. 15%.

"TTVR is showing significant trends in improving mortality and heart failure hospitalization. When you look at New York Heart Association class, as well as KCCQ and the six-minute walk distance, there are significant differences favoring a greater improvement with the transcatheter tricuspid valve replacement device," she explained.

Efficacy and quality of life using the Evoque valve

Quality of life has become a primary focus of recent tricuspid device trials. Initial trials using transcatheter edge-to-edge repair (TEER) leaflet clipping devices showed improvement in regurgitation that did not translate into significant improvements in mortality. However, overall, KCCQ scores were higher and patients reported being able to return to normal life activities, so this became the big success story and push for FDA approval of tricuspid TEER, rather than helping patients live longer.

New longer-term TRILUMINATE IDE data presented at TCT 2024 confirmed efficacy for the first time for Abbott’s TriClip device in treating tricuspid regurgitation (TR). The initial results from the first 350 patients in the trial, presented at ACC.23, show positive quality of life data, which led to the FDA approval of the Abbott TriClip in April 2024. Find out more from an interview with Gilbert H. Tang, MD.

The Evoque valve demonstrated exceptional efficacy in reducing regurgitation levels, which translated into substantial improvements in quality of life. Hahn said this reflects better symptom management and functional capacity, which lead to improved diuretic responsiveness, decreased liver congestion, and better overall patient outcomes.

Hahn she said the survival curves at one year in TRISCEND II already show separation with higher survival for TTVR patients, which she hopes will be more pronounced with further follow-ups.

The TRANSCEND II late-breaking trial was actually broken out into two parts on the primary outcomes and a separate presentation on the quality of life outcomes, presented by Suzanne V. Arnold, MD, with Saint Luke's Mid America Heart Institute at the University of Missouri-Kansas City.(2) Read more.

Details of how to implant the Evoque tricuspid valve

The Evoque TTVR system offers a streamlined implantation process using transfemoral access with a 28 French catheter. The self-expanding value is available in sizes ranging from 44, 48, 52 and 56 mm to accommodates varying annular dimensions.

She said the controls on the delivery catheter allow for significant control over trajectory and are very maneuverable. This is important because of the sharp turn from the inferior vena cava (IVC) into the right atrium.

As the valve is unsheathed under angiography, transesophageal echo (TEE) and sometimes augmented with intra-cardiac echo (ICE), the native leaflets need to be engaged by the arms of the valve. Hahn said these need to engage the leaflets to help seal the valve tightly in the annulus.  

“The nine atraumatic anchors are critical for securely capturing valve leaflets, even in complex anatomy with multiple commissures," she said. "Unlike devices with atrial flanges, the Evoque leaves the atrium unobstructed, allowing for potential coronary sinus access if needed.”

The number of tricuspid leaflets can vary between patients, but the device works very well capturing multiple leaflets and commissures, Hahn explained. 

"The beauty of the Evoque device is it has nine atraumatic anchors. So even if you miss one anchor in a commissure, it will capture the leaflet typically on either side of those commissures. The device does not have an atrial flange, and therefore once it goes in, it's using the leaflets to help close off the tricuspid regurgitation."

The device also leaves access in the atrium in case there is a need to put in a coronary sinus lead.

While there are sometimes issues accessing imaging windows for the tricuspid value in some patients because of shadowing, Hahn said TEE imaging is slightly easier because all you need really is one good imaging level. From there, she said 3D imaging can be created with a reconstruction of the entire annulus and valve leaflets. This 3D image can be rotated around to ensure all nine anchors are below the annulus and have leaflets over the top.

Overcoming pacemaker leads to implant transcatheter tricuspid valves

Many patients who suffer from tricuspid valve regurgitation have pacemakers with lead wires that go through the tricuspid valve. This can present challenges. Hahn said this has led to lower numbers of these patients (less than 20%) being included in tricuspid device trials and registries. The presence of leads can play a roll in patient selection.

"You do want to be careful about anatomic challenges and being able to get down to at least moderate regurgitation. You can still put the Evoque valve in with the lead in place. In the TRISCEND II trial, almost 40% of patients had leads. There was a higher percentage with pacemakers because the device itself does not care whether or not the lead is a adherent to the leaflets," Hahn explained.

She said her heart team always discussed whether or not they had other options in case the lead malfunctioned, or if the lead could be extracted before the valve went in. These discussions need to involve an electrophysiologist on the heart team.

Hahn added that her center has a very experienced lead extractor, so many times the leads were removed. Sometimes a Micra leadless pacemaker would be considered. Other options included the use of coronary sinus or epicardial leads.

Patient selection for the Evoque valve

Hahn said there is still a lot to learn about patient selection for the valve because the trial excluded patients with a left ventricular ejection fraction of (LVEF) of less than 25%, any evidence of severe right ventricular dysfunction, severe renal insufficiency or severe pulmonary hypertension. Data does suggest some of these patients may benefit from a reduction in tricuspid regurgitation.

She said patient selection is a very complex and requires a heart team-based discussion and shared decision-making discussion with the patient. Hahn said this is particularly important because the mortality and the heart failure hospitalization benefits have not been the same as the devices on the left side of the heart. She said this means the discussion with patients often boils down to how they feel and if this device can make them feel better.

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