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CHICAGO -- Compassionate use of the on patients with severe tricuspid regurgitation resulted in some successes, according to first-in-human data presented here.

Neil Fam, MD, MSc, of St. Michael's Hospital in Toronto, Ontario, reported on 28 people at high or prohibitive surgical risk receiving the device who showed notable clinical improvements soon after the procedure:

• From all patients classified at 3+ tricuspid regurgitation severity to 85% having severity drop to class 1-2 immediately after the procedure and remaining there at 30 days (P<0.001)
• New York Heart Association class going from virtually all III/IV to 88% in I/II at 30 days (P<0.001)
• Six-minute walk test distances up from 238 m at baseline to 334 m (P<0.001)

By 30 days, there were two deaths -- neither related to the device or the procedure -- and one heart failure hospitalization among this cohort, Fam said during a platform presentation at the annual organized by the Cardiovascular Research Foundation.

Overall, the compassionate-use experience with the device resulted in 86% procedural success with a mean of 1.4 Pascal spacers implanted per patient (the maximum was three spacers with more torrential regurgitation). Nine in ten cases made use of the independent leaflet grasping mechanism.

Procedures averaged 134 minutes, during which there was no mortality or conversion to surgery.

Study participants averaged 79 years and 54% were women. They largely presented with functional tricuspid regurgitation (82%). All were already on loop diuretics, with more than two-thirds on aldosterone antagonist therapy.

"In this first-in-human experience, the Pascal Transcatheter Valve Repair System demonstrated high procedural success, acceptable safety, and significant clinical improvement in patients with challenging tricuspid anatomy and severe TR [tricuspid regurgitation]," Fam concluded.

The Pascal system joins Edwards' other tricuspid repair systems, the spacer-and-rail Forma and the Cardioband.

Pascal in particular consists of a central spacer that fills the regurgitation area and features contoured paddles (to reduce stress on native leaflets) and longer clasps that allow for individual leaflet capture. This device already has the CE Mark in Europe for treating mitral regurgitation and is being tested against the MitraClip in the .

Now, the role of the Pascal system in tricuspid regurgitation needs to be further defined in prospective studies with long-term follow-up, Fam told the audience.

Although the independent leaflet grasping may be an advantage here, it's possible that longer arms are not always "your friend" if multiple devices need to be implanted, said session co-moderator Martin Leon, MD, of Columbia University Medical Center/NewYork-Presbyterian Hospital in New York City.

Perhaps a shorter device would be needed for more complete repair, Leon suggested.

Fam agreed and said that the Pascal implant has now been made available in two sizes.

He cautioned that this was an observational study with a small sample and no core lab adjudication of clinical and echocardiographic results.

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