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Home HEALTH PASCAL for MV repair not inferior to MitraClip: Pivotal CLASP IID

PASCAL for MV repair not inferior to MitraClip: Pivotal CLASP IID

A newly available transcatheter device for edge-to-edge mitral valve (MV) repair, named for a famous scientist-inventor, is similar to one that has long been available miter clip (Abbott Vascular) for short-term efficacy and safety, suggests an interim but prespecified analysis of a randomized trial.

In his comparison with the MitraClip, the PASCAL transcatheter valve repair system (Edwards Lifesciences) was non-inferior with respect to 30-day major adverse events and success in achieving mitral regurgitation (MR) of no more than moderate severity within 6 months. The trial enrolled patients with significant symptomatic degenerative MI considered too high risk for surgical repair or replacement.

The interim analysis covers 180 of the 300 patients followed in the study, of whom 117 received the PASCAL device and 63 received the MitraClip. Both groups showed significant gains in functional class, symptom status, and quality of life over 6 months, reported D. Scott Lim, MD, University of Virginia Health System Hospital, Charlottesville, and Konstantinos Koulogiannis, MD, Morristown Medical Center. , New Jersey. jointly on September 17 at Transcatheter Cardiovascular Therapeutics (TCT) 2022 in Boston, Massachusetts.

Lim, one of the principal investigators on the trial, is also the lead author of his same day post in JACC: Cardiovascular Interventions.

Based largely on the results of the CLOSE IID In a pivotal trial, the US Food and Drug Administration (FDA) recently approved the PASCAL system for use in patients with degenerative MR, Edwards announced Sept. 15. The device what he approved in the European Union on August 17.

MitraClip has been available in various iterations in the United States since 2013 and in Europe since 2008.

“It’s good for the field to be able to say we have two devices that are comparable,” giving clinicians more options, said Vinod H. Thourani, MD, Piedmont Heart Institute, Atlanta, Georgia. elcorazon.org | Medscape Cardiology.

The current analysis shows that “we still need to figure out which patient pathologies will be beneficial” for each of the devices, Thourani said. “The goal will be to find out if there are certain anatomical considerations where one device is better than the other.”

It will be necessary to study “more patients, a larger cohort, with longer follow-up to allow us to see its true benefits,” he said, as well as more subgroup analyses. For now, the choice of device will likely be “carrier-specific, the one you’re comfortable with.”

Thourani, who is not an author on the current study, is the US principal investigator for the CLASP IIF study looking at clinical outcomes with the two devices and says he consults with both Edwards and Abbott.

The findings are “preliminary at this time,” said Michael Young, MD, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, in part because, like most randomized trials, CLASP IID entered a select population, not broadly representative.

“They want to do, to the best of their ability, an apples-to-apples comparison, without confusion that could make it difficult to interpret later,” said Young, who is not associated with the trial. elcorazon.org | Medscape Cardiology.

But CLASP IID “enrolled patients that we see and treat, so it’s certainly a compelling study. Now we have another device that has been shown to be safe and effective. How are we going to extrapolate that to all the patients that are being referred to our practices?” It will, I think, be the subject of debate and deliberation.

The PASCAL and MitraClip devices may be better suited for different patients with various mitral valve pathologies due to differences in their designs, Lim said. PASCAL’s relative flexibility might make it preferable in patients with smaller mitral valves, and its ability to lengthen during labor might make it more suitable for patients with dense areas of chordae around the valve, she speculated.

MitraClip, said Lim elcorazon.org | Medscape CardiologyIt has a mechanical closure system by anchoring that can make it more suitable for “more complicated leaflets, thicker with calcium”.

CLASP IID enrolled patients with grade 3+ or 4+ degenerative MR who were considered to be “prohibitive surgical risk” at 43 sites in North America and Europe. He randomly assigned them 2 to 1 to receive the PASCAL or MitraClip device.

Either of two versions of PASCAL were used, the original device or the “smaller, narrower” PASCAL Ace, Lim noted. Both versions are covered by the FDA approval of the PASCAL Precision System. Around 40% of patients assigned to MitraClip received earlier versions of the device and around 60% received newer versions as they were implemented.

Mean procedure times were 88 minutes for PASCAL and 79 minutes for MitraClip (P = .023), with much of the difference attributable to early PASCAL procedures. Procedure times for the device decreased with increased operator experience, states the published report.

The primary safety endpoint rates of major adverse events at 30 days were 3.4% for PASCAL and 4.8% for MitraClip. The endpoint was a composite of cardiovascular mortality, race, myocardial infarctionnew need for renal replacement therapy, severe bleeding, or non-elective reinvention of MV.

The proportion of patients with MR grade 2+ or less at 6 months, the primary efficacy endpoint, evaluated at a central laboratory, was 96.5% for the PASCAL group during a median follow-up of 179, 5 days and 96.8% for a median of 184.5. days for those who received MitraClip.

Comparisons for both primary endpoints with PASCAL prespecified non-inferiority criteria.

In a secondary analysis, the proportion of PASCAL patients with MR grade 1 or less was stable from post-procedure discharge to 6 months, at 87.2% and 83.7%, respectively (P = .317).

But while 88.5% of MitraClip patients had grade 1 or greater MR at discharge, 71.2% were grade 1 or greater at 6 months (P = .003). That apparent hemodynamic impairment raised some eyebrows in the TCT sessions as a potential sign that PASCAL’s functional results are more durable.

That kind of judgment is premature, offered to Anita W. Asgar, MD, MSc, Montreal Heart Institute, Quebec, Canada, as a guest commentator after the formal presentation of the CLASP IID trial.

The trial is notable in part for “showing how safe this procedure is and how successful it is for these patients — this is phenomenal,” he said, but “I would caution that comparing one device is better than another with such a small number of patients.” “

The MitraClip, Young noted, “has been, to this point, our only option for edge-to-edge mitral valve repair. And many of us have years of experience and many patients we treat with that device.” His core hasn’t used PASCAL yet, but that may change as the field becomes more familiar with the device. Operators can use either device in different cases, he said.

“Depending on the schedule, and depending on the volume of mitral patients you see and the edge-to-edge repair you do, it could be that you stay with one, or switch to another, or integrate both and try to decide which patients could be more suitable for one or the other.

SQUARE BRACKET IID was sponsored by Edwards Lifesciences. Lim reports consulting for Philips, Venus, and Valgen and receives research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Koulogiannis discloses having served as a consultant and serving on an advisory board for Edwards Lifesciences and as a speaker for Abbott and discloses that he owns stock, shares or stock options in 4C. The statements of the other authors are found in the report. Thourani reveals that he served as a consultant to both Abbott and Edwards Lifesciences. Young discloses having received consulting fees or honoraria or having worked in a Medtronic speakers bureau. Asgar discloses having received research support or having had a research contract with Abbott Vascular and having received consulting fees or fees or worked on a speaker’s bureau for Medtronic, Edwards Lifesciences, and W. Gore & Associates.

Transcatheter Cardiovascular Therapeutics (TCT) 2022. Presented September 17, 2022.

JACC cardiovascular intervention. Published online on September 17, 2022. summaries

Follow Steve Stiles on Twitter: @SteveStiles2. For more information on theheart.org, follow us on Twitter other Facebook.


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