Pascal noninferior to MitraClip for treatment of degenerative mitral regurgitation
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BOSTON — A novel mitral valve transcatheter edge-to-edge repair system was noninferior to an existing system in a head-to-head trial in patients with severe symptomatic degenerative mitral regurgitation, researchers reported at TCT 2022.
For the CLASP IID trial, researchers compared the novel system (Pascal, Edwards Lifesciences) with the existing system (MitraClip, Abbott). As Healio previously reported, the Pascal system received FDA approval on Sept. 15 based on the results of CLASP IID.
Konstantinos P. Koulogiannis, MD, interventional cardiologist at Atlantic Health System Morristown Medical Center in Morristown, New Jersey, and D. Scott Lim, MD, professor of medicine and pediatrics at the University of Virginia and medical director of the UVA Advanced Cardiac Valve Center, presented results of a prespecified interim analysis of 180 patients (mean age, 81 years; 67% men), all of whom had degenerative mitral regurgitation grade 3+ or 4+ and were considered to be at prohibitive surgical risk.
Patients underwent 2:1 randomization, with two receiving the Pascal system for every one receiving the MitraClip system. The primary safety endpoint was major adverse events at 30 days. The primary efficacy endpoint was percentage of patients with mitral regurgitation grade 2+ or better at 6 months. The results were simultaneously published in JACC: Cardiovascular Interventions.
The Pascal device “has a hollow nitinol frame construction, so it closes passively and can flex more open or closed depending on the force put on it,” Lim said during a press conference. “It also allows it to elongate, so it can be maneuvered with a greater degree of confidence in areas with denser cords without getting stuck. It has a central spacer to bridge the coaptation gap so that the leaflets are not pulled tightly together, but rather are pulled to the spacer.”
Four patients (3.4%) in the Pascal group and three (4.8%) in the MitraClip group had major adverse events at 30 days. In the Pascal group, there was one CV death, three severe bleeding events and one nonelective mitral valve reintervention, and in the MitraClip group there was one CV death and two severe bleeding events, according to the researchers. Adverse event rates remained similar between the groups at 6 months (log-rank P = .231).
The primary efficacy endpoint was achieved in 96.5% of the Pascal group (P vs. baseline < .001) and 96.8% of the MitraClip group (P vs. baseline < .001), the researchers found.
Both groups improved from baseline to 6 months in functional capacity (P < .001) and quality-of-life outcomes (P for all < .05).
The proportion of patients with a mitral regurgitation grade of 1+ or better was consistent between discharge and 6 months in the Pascal group (from 87.2% to 83.7%; P = .317), but the same was not true in the MitraClip group (from 88.5% to 71.2%; P = .003), according to the researchers.
“The CLASP IID trial is the first randomized controlled trial to directly compared two TEER therapies, and further establishes the safety and the efficacy of mitral valve TEER for degenerative mitral regurgitation,” Koulogiannis said at the press conference.
A consideration for choosing which device to use is that “the two devices have different design features that I think may be beneficial in different anatomies,” Lim said at the press conference. “As an example, since the Pascal device is hollow nitinol and can flex, even though it is about twice the size of the MitraClip, the data we have suggests it can go into smaller mitral valve annuli at the same frequency of use; it’s a bigger amount of device in there, but the gradients are the same, essentially because the Pascal device doesn’t obstruct the inflow as much due to its flexibility. Whereas the mechanical closure of MitraClip is definitely much stronger, so if you are going after a valve that has calcium in the leaflet tips or very thick leaflets that need to be held together, the MitraClip may be more helpful for that.”
Reference:
Perspective
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This was a randomized clinical trial comparing the efficacy and safety of two devices: a newer one called Pascal (made by Edwards Lifesciences) and a second more established device, the MitraClip (made by Abbott). Specifically, this study aimed to show that the Pascal device was noninferior to the MitraClip device with respect to safety and efficacy.
The safety endpoint was defined as percentage of major adverse events such as CV mortality, stroke and MI. The efficacy endpoint was defined as proportion of patients with MR ≤2+ at 6 months. The take-home message for this study is that the Pascal device was noninferior to the MitraClip in terms of both safety and efficacy endpoints.
This study provides another choice of device to perform TEER in patients. Having additional device options offers more flexible and potentially better individualized therapeutic options for patients.
This was an analysis at 6 months, and it will be important to have follow up at 5 years (as already intended in the trial) to assess long-term durability and safety of the devices.
Perspective
Back to TopMatthew Romano, MD
The results expand the armamentarium for transcatheter devices that can treat patients with degenerative mitral regurgitation at prohibitively high surgical risk. There are some nuances and differences in the structure of the device, and a suggestion that there are particular areas of the native valve apparatus where the Pascal device may be of benefit, such as at the commissures.
We do not yet have a clear handle on which patient should get which device. It is too early to understand the full picture. It appears to be like choosing a Chevrolet or a Ford, and that is going to be a challenge. The presentation did mention that the design of the Pascal device may be of benefit in certain areas of the valve based on the location of the prolapse or flail, such as adjacent to the commissures as opposed to the middle of the valve. It is at the commissures where device entanglement of the chords is more likely. This device may lend itself to easier liberation of entanglement in this location.
These efforts continue to push the envelope in terms of developing devices for treating patients. It is an exciting time to treat patients in the mitral space, which is a new frontier.
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Koulogiannis KP, et al. Late-Breaking Clinical Science in Structural Heart Disease: Session I, in Collaboration With The New England Journal of Medicine. Presented at: TCT Scientific Symposium; Sept. 16-19, 2022; Boston (hybrid meeting).
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