Sustained Benefit With Pascal TEER Device at 2 Years: CLASP IID and MiCLASP

LONDON, England—Two-year results from the CLASP IID randomized trial and registry confirm the early benefits of transcatheter edge-to-edge repair (TEER) with the Pascal system (Edwards Lifesciences) for patients with degenerative mitral regurgitation (MR) at too high risk for surgery.

In the trial, which included patients with significant, symptomatic MR (3+ or 4+) randomized to TEER with Pascal or MitraClip (Abbott), there was no significant difference in MR reduction, quality of life, or functional or clinical outcomes between the two devices at 2 years, reported investigators last week at PCR London Valves 2024.

Another presentation released at the meeting, this one sharing data from the single-arm MiCLASP study of Pascal in patients with both functional and degenerative MR, also was encouraging. For both the CLASP II registry, which included degenerative MR only, and MiCLASP, investigators reported favorable outcomes at 2 years despite the inclusion of patients with complex anatomy.

“Now, I think the question is, what device do you use?” said lead investigator Raj Makkar, MD (Cedars-Sinai Medical Center, Los Angeles, CA), during the hotline session. “I have a lot of experience with the MitraClip device. It’s a great device, but I think there are certain features of the Pascal device that are very attractive. One of the features I am drawn to is the ability to elongate and the ability to bail out. When you’re working in the commissures, there is a greater chance of being entangled in the chords and I’m more inclined to use the Pascal device.”

On the other hand, he said, there may be situations in which a smaller device is needed, so physicians may opt for MitraClip, which has four clip sizes, including the smaller NT version.

“So, I think it all depends upon the anatomy,” said Makkar. “When the posterior leaflet is very short, I am much more inclined to go to the MitraClip device than to the Pascal. I think you can use either device in most cases—it’s a question of personal choice.”

Scott Lim, MD (University of Virginia School of Medicine, Charlottesville), another CLASP IID investigator, said the 2-year results confirm that TEER is safe and effective with both devices.

At 6 months, “there seemed to be a diminution of the efficacy in the MitraClip arm for those getting down to [MR 1+], and visually you still see that trend, but statistically it’s not a significant difference,” Lim told TCTMD. “I think what we really have to point to here is that for 80% of patients with straightforward anatomies, they can be randomized either way and do really well with either device.”

When it gets down to the nuts and bolts, Lim said there are some conceptual differences between valves which operators will take into account when choosing.

MitraClip, which is closed mechanically, may be preferred in certain patients, such as those with calcification on the leaflet tips, because operators may require a stronger closure, said Lim. For patients with a small mitral valve orifice area, the “nitinol-based Pascal device flexes through the cardiac cycle, and even though it’s physically bigger, it can actually go into smaller orifices with less impact on the gradients,” he said.    

Benefits Sustained to 2 Years

CLASP IID, conducted at 54 sites in the United States, Canada, and Europe, included 300 patients (mean age 81 years; 35% women) with degenerative MR deemed anatomically suitable for either device. The primary endpoints of the trial were a composite of major adverse events at 30 days for safety and the proportion of patients with MR graded as 2+ or less at 6 months for efficacy. As previously reported, Pascal was shown to be noninferior to MitraClip, with the equivalent results sustained out to 1 year.

In the 2-year follow-up, which is based on complete data from 151 patients treated with Pascal and 81 treated with MitraClip, there was a sustained and significant reduction in core lab-adjudicated MR with both devices. With Pascal, 94.9% of patients had moderate or less MR (MR 2+ or less) compared with 93.2% of those treated with MitraClip, a nonsignificant difference.

Transmitral gradients upon discharge were sustained out to 2 years in both study arms, with no difference between devices. There was also evidence of left ventricular remodeling in the Pascal- and MitraClip-treated patients, with investigators reporting a significant and sustained reduction in LV end-diastolic volume (LVEDV) and diameter (LVEDD) from 30 days to 2 years.

“The same holds true for the functional and quality-of-life outcomes,” said Makkar. “The benefits were sustained up to 2 years, with 88% of the patients being in NYHA class I or II in the Pascal and MitraClip groups.” Clinical outcomes, including survival and freedom from cardiovascular mortality, heart failure hospitalization, or reintervention, were similar in both groups.

I think you can use either [MitraClip or Pascal] in most cases—it’s a question of personal choice. Raj Makkar

The registry analysis, which Makkar also presented, focused on 98 patients (mean age 81.1 years; 61.2% male) with anatomical exclusion criteria who were not randomized in the CLASP IID trial but were treated with the Pascal device. Despite complex anatomy, including two or more independent significant jets or a small mitral valve orifice area, 92% of patients treated with Pascal had moderate or less MR at 2 years.

Like in the randomized trial, the improvement in mean transmitral gradient was sustained out to 2 years, as was the reduction in LVEDV and LVEDD. Functional and quality-of-life outcomes were improved at 2 years, with 83.7% of Pascal-treated patients in NYHA class I or II. Clinical outcomes at 2 years, said Makkar, were “quite favorable given the type of patients that were enrolled in this registry.”

Regarding patients with functional MR, who were excluded from CLASP IID, Makkar said a separate trial—CLASP IIF—is currently underway.

MiCLASP at 2 Years

During the same late-breaking trials session, Tobias Geisler, MD (University Hospital Tübingen, Germany), presented 2-year outcomes with Pascal from MiCLASP, a prospective, multicenter, postmarketing study in patients with symptomatic functional and degenerative MR. Of the 600 people (mean age 77.4 years; 58.3% male) enrolled in the study, 2-year follow-up was available in 303.

Cardiovascular mortality at 2 years was 10%, which Geisler said is “quite low” in this sick patient population. Compared with the year prior to study enrollment, investigators observed a significant reduction in HF hospitalizations in the 2 years after device implantation. This reduction was seen in patients with functional and degenerative MR, although the benefit was less in those with functional MR, he said.

There’s also an unarguable and substantial reduction in heart failure hospitalization, which is a very important measure. David Hildick-Smith

Overall, 98.6% had moderate or less MR at 2 years, a reduction that was consistent in those with functional and degenerative MR, as well as those with complex anatomy. Like in CLASP IID, there were improvements in LV remodeling, functional outcomes, and quality of life.

David Hildick-Smith, MD (Brighton and Sussex University Hospitals, Brighton, England), one of the discussants during the session, said “there’s lots to like” about the MiCLASP study, including its size. While mortality was 16.7% at 2 years, this reflects the patient population rather than the device, he said, adding that Pascal-related safety issues are quite rare. Rates of device embolization and single-leaflet device attachment were low at 0.2% and 1.5%, respectively.

“There’s also an unarguable and substantial reduction in heart failure hospitalization, which is a very important measure, both for the patient and from a health economic point of view,” said Hildick-Smith.