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The latest mitral valve repair and replacement devices were associated with favorable outcomes thus far, investigators reported.

The Evoque, Tendyne, and Pascal devices are poised as potential alternatives to MitraClip repair or surgical treatment for mitral regurgitation (MR). Early-to-midterm data in people with symptomatic, moderate-to-severe MR were presented during the virtual , held this year in lieu of the EuroPCR conference.

Evoque for Valve Replacement

Transfemoral transcatheter mitral valve replacement (TMVR) with transseptal puncture was found to be feasible with the Evoque valve, a first-in-human study found.

Among the 14 patients in the study, one had a non-cardiovascular death and two had a stroke by 30 days. There were no myocardial infarctions (MIs) nor rehospitalizations at that point. Two people underwent paravalvular leak closure and one received alcohol septal ablation for left ventricular outflow tract obstruction, reported John Webb, MD, of St. Paul's Hospital in Vancouver, British Columbia.

A full manuscript was published simultaneously in .

MR was less than mild in all implanted patients at 30 days (83.3% had no MR). Symptoms improved from 64.3% of patients being in New York Heart Association (NYHA) class III or worse at baseline to 81.8% left with NYHA class II symptoms (with 18.2% still classified as class III).

The Evoque valve comprises a self-expanding frame, leaflets, and a fabric skirt, and a unique anchoring mechanism uses the annulus, leaflets, and chords for secure placement.

Valve replacement has the advantage of being applicable to a wider range of anatomies, according to Webb's group.

Study participants had a median age of 84. MR was classified as degenerative in 28.6% of the patients, functional in 21.4%, and mixed in 50%.

Technical success was noted in 92.9%, and one person converted to surgery.

The "reasonable number deaths" in this high-risk cohort was highlighted by session discussant Francesco Maisano, MD, of University Hospital Zurich in Switzerland.

He cautioned, however, that this is an early experience in a limited number of patients who were probably highly selected given that left ventricular ejection fraction was over 50%.

Nevertheless, he said, the study offers "promising data" that transfemoral-transseptal TMVR can be safely performed.

An is ongoing and planned for 58 participants, Webb noted.

Tendyne for Valve Replacement

TMVR with the Tendyne bioprosthetic resulted in fairly good outcomes at 2 years, though stroke and bleeding rates appeared elevated, a study showed.

Disabling stroke occurred in 5.0% of study participants, MI in 8.0%, mitral valve re-intervention in 5.0%, endocarditis in 5.0%, major bleeding in 35.0%, new permanent pacemaker implantation in 8.0%, and new-onset atrial fibrillation in 9.0%.

All-cause mortality was 27% at 1 year and reached 41.6% by 2 years (most deaths being cardiovascular), according to David Muller, MD, of St. Vincent's Health Australia, who reported on the first 100 patients to complete 2-year follow-up in the .

Although mortality was "reasonable" in the study, the stroke and bleeding rates observed are a concern and may be related to an issue of anticoagulation following TMVR requiring further analysis, Maisano suggested.

At 1 year, 98.9% of the group had no MR. By 2 years, 93.2% still had no MR, with the remainder showing grade 1+ MR.

Tendyne is a tri-leaflet bioprosthetic valve that is held in position by a tether attached to an apical pad placed over the ventricular access site. It is approved for commercial use in Europe.

Patients had entered the study at a mean age of 74.7. Men accounted for 69.0% of the cohort. Two-thirds had NYHA class III/IV symptoms, and 92.0% had grade 4+ MR.

Muller highlighted the sustained clinical improvement observed in terms of NYHA classification (81.7% in class I/II at 2 years) and a 19-point improvement on the Kansas City Cardiomyopathy Questionnaire (KCCQ; both P<0.0001). Moreover, heart failure hospitalizations fell from 1.30 to 0.51 per patient-year, P=0.01).

Outcomes at 2 years, therefore, were "very acceptable considering the advanced age and underlying comorbidities," Muller told the audience.

Pascal for Valve Repair

Finally, the Pascal transcatheter valve repair system emerged from the CLASP study with good safety and efficacy data out to 1 year.

The 14.5% composite rate of major adverse events included a 6.5% incidence of cardiovascular mortality, 1.6% MIs, 9.7% severe bleeding, 1.6% re-intervention for device-related complications, and no strokes or new need for renal replacement therapy.

Survival was 92% for the 109-person cohort at 1 year, when patients also showed an 88% rate of freedom from heart failure hospitalization, according to another presentation by Webb with the manuscript published simultaneously in .

MR severity dropped to grade 1 or below in 82% of patients (all were grade 2 or below). Significant clinical improvement was also noted from NYHA symptoms (88% were in NYHA class I/II) and a 14-point boost on the KCCQ.

"In the CLASP study, the Pascal repair system was safe and performed as intended," Webb concluded.

The Pascal device features two adjustable clasps for independent leaflet grasping, paddles to reduce leaflet stress, and a central spacer that fills the regurgitant gap. Like the Tendyne, Pascal is already CE Marked in Europe for treatment of MR, and is also being investigated for use in tricuspid valve repair.

Patients included in the study were an average 75.5 years old, and were divided between those who had functional MR (67%) and those with degenerative MR (33%).

The comparing the Pascal and the MitraClip is ongoing, Webb said.

Maisano cautioned that these were very selected patients with central MR, as the investigators had excluded people with commissural lesions that merit further investigation.