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The Mitralign device for transcatheter tricuspid valve annuloplasty safely helped to better the quality of life of heart failure patients with torrential tricuspid regurgitation, a feasibility study suggested.

Patients receiving the device, also known as Trialign, showed substantial improvement in New York Heart Association (NYHA) functional class, Minnesota Living with Heart Failure Questionnaire scores (mean 47.4 to 20.9 points, P<0.001), and 6-minute walk tests (mean 245 to 298 meters, P=0.008) on intention-to-treat analysis.

At 30 days, tricuspid regurgitation fell from median 92.7 mL to 55.9 mL, though this was not statistically significant (P=0.811). This improvement approached statistical significance in the as-treated analysis, however (88.0 to 51.1 mL, P=0.065), according to Rebecca T. Hahn, MD, of Columbia University Medical Center/New York-Presbyterian Hospital, and collaborators in the .

Mitralign plicates the tricuspid annulus, replicating the modified Kay procedure. The early data were published in the April 11, 2017 issue of the .

"Although the reduction in tricuspid regurgitation seems modest at first glance, this is probably related to the baseline tricuspid regurgitation, which was torrential and associated with severe annular dilation and a distance between the posterior commissures that is >2.8 cm of plication achieved with a single pair of pledgets," asserted Azeem Latib, MD, of San Raffaele Scientific Institute, and Antonio Mangieri, MD, of EMO-GVM Centro Cuore Columbus, both in Milan, in an .

A major challenge of transcatheter tricuspid intervention, the editorialists suggested, is that patients who are referred for treatment tend to have "massive" tricuspid regurgitation.

"If the field of transcatheter tricuspid valve intervention is to be successful, we need to rethink how we currently approach functional tricuspid regurgitation. Diuretic therapy improves symptoms and reduces volume overload but do not change the course of the disease once annular dilatation occurs. Thus, in order for these therapies to be truly effective in changing the natural history of functional tricuspid regurgitation, the cardiology community needs to challenge the conventional approach to the tricuspid valve."

Latib and Mangieri urged: "We need to stop ignoring the tricuspid valve or making excuses for not treating moderate to severe functional tricuspid regurgitation with annular dilatation. Surgical repair of annular dilatation at the time of left-sided heart surgery should become standard practice, and earlier treatment of significant tricuspid regurgitation, regardless of whether surgically or percutaneously, needs to become widely accepted."

The Mitralign (or Trialign) system received Europe's for functional mitral regurgitation in 2016.

The SCOUT trial had 15 patients enrolled from 2015 to 2016. To be eligible, participants had to have NYHA functional class of 2 or greater with at least moderate functional tricuspid regurgitation. The average age was 73.2 years, with 87% of the study group being women.

Mitralign placement was successful in all cases: no deaths, strokes, bleeds, tamponade, or valve reinterventions were observed by Hahn's group.

Thirty days out, however, technical success had dropped to 80%: 3 out of the 15 patients had single-pledget annular detachments without reintervention. The remaining patients showed narrowed tricuspid annuli (11.3 cm² from 12.3 cm², P=0.019) and reduced effective regurgitant orifice areas (0.32 cm² versus 0.51 cm², P=0.020) on an as-treated basis.