October 19, 2018
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Valve repair with transcatheter device reduces tricuspid regurgitation

Jorg Hausleiter
Jörg Hausleiter

SAN DIEGO —Interventional tricuspid edge-to-edge valve repair with a transcatheter device in patients with tricuspid regurgitation was safe and resulted in a high procedural success rate, according to data from the TriValve registry presented at TCT 2018.

Jörg Hausleiter, MD, of Ludwig-Maximilians Universität München in Munich, and colleagues analyzed data from 249 patients (mean age, 77 years; 51% women) with tricuspid regurgitation who underwent edge-to-edge therapy with a transcatheter device (MitraClip, Abbott).

“The rationale for this was fourfold,” Hausleiter said during a press conference. “We wanted to investigate the procedural outcome, the durability of [tricuspid regurgitation] reduction at 1 year, the clinical outcome at 1 year including mortality and unplanned hospitalizations and to finally identify predictors for both procedural failure and also 1-year mortality.”

The main outcome measures of interest were NYHA class, unplanned repeat hospitalizations, tricuspid regurgitation grade and presence of peripheral edema.

A mean of two clips (range, 0-5) were placed into the tricuspid valve, according to the press conference.

Tricuspid regurgitation was reduced by at least one grade in 89.2% of patients, and 51.8% of patients had concomitant mitral regurgitation treatment in the same procedure. At baseline, the majority of patients had a tricuspid regurgitation grade between 3+ and 4+, which was reduced to an estimated 77% of those having a grade between 1+ and 2+ at discharge.

Independent predictors for procedural failure were tricuspid regurgitation jet location, tricuspid regurgitation effective regurgitant orifice area greater than 0.7 cm2, tenting area greater than 3.15 cm2 and a leaflet gap greater than 6.4 mm.

At 1 year, 70.1% had procedural success and 49.7% had procedural failure regarding all-cause mortality and repeat hospitalizations (log-rank P < .0001).

A tricuspid regurgitation grade of 2+ or lower was seen in 72% of patients at 1 year (P < .001).

The majority of patients at baseline had a NYHA class of III or IV. At 1 year, 69% of patients had a class of I or II (P < .001). Peripheral edema improved from 84% at baseline to 26% at follow-up (P < .001).

“We were able to demonstrate that this procedure can be performed very safely,” Hausleiter said during the press conference. “There was just a mortality rate of 2% within the first 30 days, and one conversion to surgery. We were able to demonstrate that the [tricuspid regurgitation] reduction is durable and that this also improves the clinical outcomes at 1 year.” – by Darlene Dobkowski

Reference:

Hausleiter J, et al. Late-Breaking Clinical Science 1. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.

Disclosure: Hausleiter reports he received research support and speaker honoraria from Abbott Vascular and Edwards Lifesciences.