麻豆传媒

Progress continues to be made on new transcatheter devices for the treatment of severe mitral and tricuspid regurgitation, investigators reported.

Several valve repair and replacement technologies, designed as alternatives to surgery in high-risk patients, had promising early results presented at this year's virtual European Association of Percutaneous Cardiovascular Interventions (EuroPCR) meeting.

The larger pivotal trials for these devices are not expected to be completed for at least another few years. As such, the following all remain investigational devices in the U.S.

Tendyne in Mitral Valve Replacement

Operators reported good real-world experience with Tendyne, a tri-leaflet bioprosthetic valve from Abbott, in registry data going out to 30 days.

Tendyne received the CE Mark from European regulators for transcatheter mitral valve implantation in January 2020.

Since then, 96 patients with mitral regurgitation (MR) had the Tendyne successfully implanted across 31 European centers. None or trace MR was recorded for 95.8% of patients at discharge, which grew to 100% at 30 days.

There were zero perioperative deaths, strokes, or device embolizations during the Tendyne procedure. One person had left ventricular outflow tract obstruction. The cardiovascular mortality rate was 9.4% at 30 days.

By then, New York Heart Association (NYHA) classification improved, from the majority being class III at baseline to class I or II in 66.1%.

is the ongoing trial pitting the Tendyne system against the MitraClip in patients with moderate-to-severe MR or symptomatic mitral valve disease due to severe mitral annular calcification. Study completion is expected in 2026.

Pascal (Ace) in Mitral Valve Repair

Use of the CE-Marked Pascal transcatheter mitral repair device was associated with a reduction of MR and good clinical outcomes at 2 years in the , which was conducted at various centers in the U.S., Canada, Australia, and Europe.

Among the 48 out of 124 study participants with 2-year follow-up, MR was cut down to 2+ or better in 97% of patients (1+ or better in 78%). Pascal recipients had a survival rate of 80%, as well as a freedom from heart failure rehospitalization rate of 84%.

At 2 years, 93% of patients were classified as NYHA class I or II.

Notably, the thinner Pascal Ace had become available toward the end of CLASP enrollment, and the analysis included Ace recipients as the last 12 people in the study.

The original Pascal device from Edwards Lifesciences features two adjustable clasps for independent leaflet grasping, paddles to reduce leaflet stress, and a central spacer that fills the regurgitant gap. Pascal Ace measures 5- to 6-mm in width compared with Pascal's 10-mm width, and features a smaller spacer.

A separate report from a high-volume Swiss center alone showed that the newer Pascal Ace performed about as well as the original Pascal in both mitral and tricuspid valve repair.

In 50 procedures logged since September 2020, technical success with Pascal Ace was just a few percentage points below that with a historical Pascal cohort, as were the odds of patients reaching MR grade 1+ and tricuspid regurgitation (TR) grade 1+/2+.

Both Pascal Ace and Pascal were associated with NYHA functional class improvement after mitral and tricuspid repair.

investigators are conducting paired trials of Pascal mitral valve repair against MitraClip therapy in patients with degenerative and functional MR. The trials are expected to be completed in 2028.

Pascal (Ace) in Tricuspid Valve Repair

Transcatheter tricuspid valve repair reduced TR severity at 6 months for most patients in the small CLASP TR early feasibility study.

Implantation of the Pascal and Pascal Ace devices was successful in 91% of 63 U.S. patients with severe TR. The procedural success rate was 98%, and the clinical success rate was 87%. About a third of study participants had received the Pascal Ace in this study.

The 42 patients with 6-month follow-up had TR severity drop from largely massive or torrential at baseline to mostly moderate (a quarter of people had none/trace or mild TR). TR was reduced by at least one grade in 89% of patients (and at least two grades in 70%).

Rates of cardiovascular mortality and severe bleeding at 6 months were 3.2% and 6.3%, respectively. Eighty-four percent of patients were in NYHA class I or II.

The comparing the Pascal system against optimal medical therapy is underway, with an estimated completion date in 2027.

TriClip in Tricuspid Valve Repair

Use of the TriClip tricuspid valve repair system was associated with positive real-world outcomes, the showed.

In this European post-approval study, 75 patients with symptomatic, severe TR enjoyed 100% implant success and acute procedural success. Most patients needed two clips during the TriClip procedure.

TR was reduced to moderate or less at discharge in 84% of participants (and reached none/trace or mild status in 46%). All patients had TR reduced by at least one grade.

There were no major adverse events at discharge. However, operators did report major bleeding in 4.0% of cases, single leaflet device attachment in 5.3%, and tricuspid valve stenosis in 2%.

Abbott's TriClip, based on the MitraClip, clips together the tricuspid valve leaflets in transcatheter edge-to-edge repair. , a newer version of the TriClip, was recently given the CE Mark.

The original TriClip received its CE Mark in April 2020 following 6-month results of the .

Two-year outcomes of TRILUMINATE were reported at this year's EuroPCR meeting.

The study was conducted at 21 sites in Europe and the U.S.; 2-year data were available for 48 patients.

The 62% rate of none/trace to moderate TR at 30 days was maintained to 60% at 2 years, with the 12% rate of massive or torrential TR falling to 2%. TR fell by one grade in 85.4% of patients, consistent with 30-day data from the study.

Notably, hospitalizations fell from 1.30 per patient-year in the year before TriClip placement to 0.66 per patient-year at 2 years (P<0.0001). All-cause mortality reached 18.7% by then.

TRILUMINATE participants also showed sustained improvement in NYHA classification, 6-minute walking distances, and quality of life per the Kansas City Cardiomyopathy Questionnaire.

Enrollment is ongoing for the comparing TriClip repair with medical therapy for severe TR. That trial is projected to be completed in 2027.

Evoque in Tricuspid Valve Replacement

Preliminary data suggested good early performance of transfemoral tricuspid valve replacement with the Evoque device.

Device success was 98% in , a prospective single-arm study with 56 patients enrolled at nine centers so far.

Of the 47 patients with 30-day results, 98% had TR classified as none/trace or mild at 30 days. All Evoque recipients achieved at least one grade reduction in TR, and 95% at least two grade reductions, at 30 days.

By then, the cardiovascular mortality rate was 1.9%, and non-elective tricuspid valve re-interventions were needed in 3.8%. Notably, 22.6% of patients experienced severe bleeding, though no such event was life-threatening or fatal.

More than three-quarters of patients were placed in NYHA class I or II.

The Evoque valve comprises a self-expanding frame, leaflets, and a fabric skirt. A unique anchoring mechanism uses the annulus, leaflets, and chords for secure placement and is compatible with pre-existing leads.

Evoque's pivotal trial, , is expected to be completed in 2028. The trial is comparing the Evoque procedure with optimal medical therapy in patients with severe TR.

The valve from Edwards Lifesciences is also under investigation for use in .

Cardioband in Tricuspid Valve Repair

Finally, the Cardioband tricuspid repair system was shown to reduce severity in patients with functional TR, researchers reported.

The Cardioband from Edwards Lifesciences provides transfemoral direct annular reduction therapy in functional TR.

In , Cardioband valve repair was associated with 97% device success among 61 patients.

In 59 patients with sufficient follow-up, TR severity was reduced from largely severe-to-torrential at baseline to none/trace to moderate in 69% of patients (36% with none/trace to mild) at 30 days. In total, 85% of patients had at least one grade reduction in TR at 30 days.

Reported adverse events included death (1.6%), coronary artery injury requiring intervention (6.6%), conduction disorders requiring permanent pacing (1.6%), and severe bleeding (11.5%, none fatal).

TriBAND offered early evidence of right heart remodeling by 30 days in terms of mid-right ventricular end-diastolic diameter, right atrial volume, and inferior vena cava diameter.

Additionally, NYHA classification improved, with the majority of patients in class III at baseline dropping to three-quarters in class I or II at 30 days.

The Cardioband is up against medical therapy in the , scheduled for completion in 2024.

Comment