Sustained mitral regurgitation reduction for high-risk patients with Pascal system: CLASP IID
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Key takeaways:
- Patients with severe degenerative mitral regurgitation saw sustained benefits with a novel transcatheter edge-to-edge repair system.
- Improvements in mitral regurgitation were sustained at 1 year.
SAN FRANCISCO — Data show a novel transcatheter mitral valve edge-to-edge repair system was associated with a sustained reduction in mitral regurgitation plus functional and quality-of-life gains for patients at prohibitive surgical risk.
For the CLASP IID trial, which was designed for noninferiority, researchers compared the novel system (Pascal, Edwards Lifesciences) with the existing MitraClip system (Abbott). As Healio previously reported, the Pascal system received FDA approval on Sept. 15 based on the results of CLASP IID.
The Pascal system features independent grasping, atraumatic clasp and closure, and elongation functionality enabling the treatment of degenerative mitral regurgitation (MR), Firas Zahr, MD, director of interventional cardiology, co-director of the complex heart valve program and associate professor in the division of cardiovascular medicine at Oregon Health and Science University, said during a press conference at TCT 2023.
“The vast majority of patients [in CLASP IID] had MR of 4-plus at baseline and significantly improved immediately after the procedure, where the majority of patients had an MR of 2-plus or less at discharge,” Zahr said. “This was sustained out to 1 year.”
Reductions from severe to moderate MR
Zahr and colleagues analyzed data from 300 adults with significant symptomatic degenerative MR who were deemed to be at prohibitive surgical risk; frailty was the most common reason. Researchers randomly assigned patients to receive the Pascal (n = 204) or MitraClip (n = 96) system.
Different generations of the Pascal and MitraClip systems were used in the CLASP IID trial, which reflects the evolution of transcatheter mitral valve edge-to-edge repair (M-TEER) technology and clinical practice. The latest-generation MitraClip G4 system was used in 68.4% of the MitraClip group; the Pascal Precision system, which became available toward the end of the enrollment period, was only used in 21.1% of cases.
Researchers assessed safety at 30 days, effectiveness at 6 months, and effectiveness and clinical, echocardiographic, functional and quality-of-life outcomes at 1 year. The primary safety endpoint was the composite major adverse event rate at 30 days, including CV mortality, stroke, MI, need for renal replacement therapy, severe bleeding and nonelective mitral valve reintervention. The primary effectiveness endpoint was the proportion of patients with moderate or greater MR at 6 months.
The findings were simultaneously published in JACC: Cardiovascular Interventions.
At 1 year, differences in survival, freedom from HF hospitalization and major adverse events were nonsignificant (P > .05 for all). The proportion of patients with major adverse events at 30 days was comparable in both groups, at 4.6% in the Pascal group and 5.4% in the MitraClip group (absolute difference, –0.8%). The Kaplan-Meier estimate for freedom from major adverse events at 1 year was 84.7% for the Pascal group and 88.3% for the MitraClip group (P = .471).
“A high proportion of patients enjoyed freedom from major adverse events at 30 days and that continued out to 1 year,” Zahr said. “There was very low all-cause mortality as well as CV mortality, and a low HF hospitalization rate that carried out to 1 year.”
A reduction in MR to moderate or less was achieved by 97.9% of patients in the Pascal group and 95.7% of patients in the MitraClip group (absolute difference, 2.2%). This result is consistent with the previously reported primary effectiveness endpoint for the initial cohort, Zahr said.
The proportion of patients with moderate or less MR at 1 year was 95.8% in the Pascal group and 93.8% in the MitraClip group (absolute difference, 2.1%). The proportion of patients with mild or less MR at 1 year was 77.1% in the Pascal group and 71.3% in the MitraClip group (absolute difference, 5.8%).
Quality of life, registry data
In both groups, the researchers reported significant improvements in NYHA functional class and Kansas City Cardiomyopathy Questionnaire score from baseline to 1 year (P < .05 for all). At 1 year, differences in functional and quality-of-life outcomes between the two groups were not significant.
“The 1-year results really advocate for the advancement of mitral TEER as an important treatment option for prohibitive surgical risk patients with degenerative MR and confirm the safety and efficacy of the Pascal system in this group,” Robert Smith, MD, cardiothoracic surgeon at Baylor Scott and White The Heart Hospital in Plano, Texas, said during the press conference. “We saw high survival and low HF hospitalization rates, which were consistently achieved and maintained throughout the 1-year period. We saw significant and sustained MR reduction ... accompanied with echocardiographic improvements.”
The trial also included a nested registry for patients ineligible for randomization due to complex mitral valve anatomy, Smith said. In that analysis, which included 98 patients, 1-year Kaplan-Meier estimates of freedom from composite major adverse events, all-cause mortality and HF hospitalization were 83.5%, 89.3% and 91.5%, respectively. Significant MR reduction was achieved at 1 year (P < .001 vs. baseline), including 93.2% at moderate MR or less and 57.6% at mild MR or less, with improvements in related echocardiographic measures, Smith said. The registry findings were also simultaneously published in JACC: Cardiovascular Interventions.
Question of what defines ‘prohibitive risk’
During a Q&A session after the press conference, Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, FSCAI, professor of medicine and director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Weiner Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai, asked how the “magnificent” outcomes seen in CLASP IID were possible considering the patients were deemed “prohibitive risk.”
“These are great outcomes with survival out to 1 year,” Mehran said. “Are these really prohibitive risk patients?”
Zahr said the data speaks to safety of the M-TEER therapy.
“We have seen very low major adverse events at 30 days and at 1 year in a very sick patient population, and this speaks for the safety of the TEER procedure,” Zahr said. “The safety did not come at the expense of efficacy. Efficacy of MR reduction was remarkable.”
Smith also noted that the CLASP IID results cannot be compared with outcomes seen after mitral valve surgery.
“This is a patient population that really does not have options,” Smith said. “We are not talking about the same group of people [as candidates for surgery]. When you don’t have an option, this is an amazing therapy.”
References:
- Rogers JH. JACC Cardiovasc Interv. 2023;doi:10.1016/j.jcin.2023.10.026.
- Smith RL, et al. JACC Cardiovasc Interv. 2023;doi:10.1016/j.jcin.2023.10.020.
- Zahr F, et al. JACC Cardiovasc Interv. 2023;doi:10.1016/j.jcin.2023.10.002.
Perspective
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With the CLASP IID data, it is nice to see that we now have two devices that are very effective for degenerative MR in patients who are not good surgical candidates. To see 93% to 95% success rates on reducing MR in patients who have structural problems with the valve and are not good surgical candidates is very good. Safety was excellent.
For the last 2 decades, TEER of the mitral valve has improved dramatically. As someone who started doing these procedures in 2011, I can say that it is like night and day. Today, we can take older patients and promise them greater than 90% success in most instances. The patients come back and generally do feel better. That is very rewarding as a physician.
Remember, we had our early challenges with the mitral valve space, just like we do now in the tricuspid space. We eventually figured it out, and now we have lifesaving therapy with MitraClip. Hopefully, Pascal will be the same. We still have work to do. The combination of patient selection, proper trial design and device iterations, plus imaging improvements in the future, will make this more predictable and better.
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Zahr F, et al. Late-breaking clinical trials: Session III, in collaboration with the Journal of the American Medical Association. Presented at: TCT Scientific Symposium; Oct. 23-26, 2023; San Francisco (hybrid meeting).
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