Transcatheter mitral valve repair with the PASCAL device showed high rates of survival and freedom from heart failure rehospitalization at 2 years in the single-arm, safety and efficacy CLASP study.
The early reductions in mitral regurgitation (MR) were sustained with 97% of patients having MR grades of 2+ or less and 78% having MR grades of 1+ or less at 2 years.
There was also evidence of left ventricular (LV) reverse remodeling and significant improvements in functional status, Molly Szerlip, MD, Baylor Scott & White Health, Plano, Texas, reported as lead author. The results were published online May 18 in JACC: Cardiovascular Interventions.
“The PASCAL transcatheter valve repair system is a favorable option for treating patients with MR,” she said in a simultaneous virtual presentation at the 2021 Congress of European Association of Percutaneous Cardiovascular Interventions (EuroPCR 2021).
The PASCAL system is not approved in the United States, but Szerlip observed that the investigators are eagerly awaiting results from the ongoing, pivotal CLASP IID/IIF trial comparing the edge-to-edge repair system with another such device, MitraClip, in 1275 patients with functional or degenerative MR. The primary completion date is set for December 2023.
Abbott’s MitraClip has been available in the US since 2013 and in Europe since 2008; Edwards Lifesciences received a CE mark for the PASCAL system in 2019.
“The results of the CLASP study are remarkable and indicate an additional differentiated tool ready for clinical routine,” Georg Goliasch, MD, PhD, and Philipp Bartko, MD, both from the Medical University of Vienna in Vienna, Austria, write in an accompanying editorial.
As both systems target similar lesions, there might be “significant overlap in this particular patient population,” Goliasch told theheart.org | Medscape Cardiology. From a technical perspective, the separate leaflet grasping was initially one of the advantages of the PASCAL, but this has also been recently introduced for the MitraClip.
That said, the “PASCAL device may offer a leaflet repair with decreased mechanical leaflet traction — specifically appealing to treat ventricular secondary MR — because mechanical forces applied to leaflets remain low, and the [central] spacer augments the leaflet surface in a way that reduces restrictive diastolic opening,” he added. “However, this remains highly speculative.”
The CLASP study enrolled 124 patients (56% male) with symptomatic MR grade of at least 3+ who were receiving optimal medical therapy at 14 sites in five countries. Their mean age was 75 years, 69% had functional MR (FMR), 31% had degenerative MR (DMR), and 60% were NYHA functional class III to IVa.
The primary endpoints of procedural and clinical success and adverse events at 30 days and 1-year outcomes were published last year. Echocardiographic data were available for 36 patients at 2 years with follow-up ongoing.
Composite major adverse event rates were 8.1% at 30 days, 18.5% at 1 year, and 16.9% at 2 years, driven mostly by severe bleeding at 7.3%, 11.3%, and 7.3%, respectively, Szerlip said.
Kaplan-Meier estimates showed 80.3% survival at 2 years (72.3% FMR, 94.3% DMR) and 84.3% freedom from heart failure rehospitalization (77.5% FMR, 97.3% DMR). The annualized HF rehospitalization rate fell to 85% at 2 years.
These results, the authors noted, hinged on minimizing residual MR. In the FMR group, 100% and 95% of patients achieved MR ≤2+ at 1 year and 2 years, respectively, compared with 95% and 99% treated with the MitraClip in the COAPT study.
In the DMR group, 100% of patients achieved MR ≤2+ at both 1 and 2 years, which “compares favorably to 94% from the EXPAND study at 1 year” with the MitraClip NTR and XTR systems, they write.
In CLASP, the LV end-diastolic volume decreased by 11 mL at 30 days and continued to decrease at 1 year (25 mL) and 2 years (33 mL; P < .001).
LV end-diastolic diameter (LVEDD) fell by 2.7 mm at 30 days, 3.9 mm at 1 year, and by 2.7 mm at 2 years (P = .002). At 2 years, 93% of patients were in NYHA class I or II (P < .001).
“The authors of the trial observed significant LV reverse remodeling with a decrease in LVEDD. These findings are indeed of particular interest and warrant further investigation by future studies as this has not been shown to such an extent in previous E2E [edge-to-edge] repair studies,” Goliasch told Medscape.
He raised an eyebrow, however, at the cross-trial comparisons, adding, “We should be very careful to draw any hasty conclusions considering the high proportion of missing echocardiographic data. Nevertheless, all these aspects might make the design of future studies for direct comparisons between E2E devices in the various structural aspects of mitral valve disease attractive to tailor treatment and optimize patient care.”
Szerlip and colleagues cited several study limitations including the absence of a control arm that may have contributed to a Hawthorne effect; not all patients had reached 2-year follow-up at the time of the analysis; and adjudication of events and assessment of the 6-minute walk test and quality-of-life measures were limited to 1 year based on the protocol.
The study was sponsored by Edwards Lifesciences. Szerlip reported serving as a proctor/speaker for Edwards; a national principal investigator for EFS; a speaker for Boston Scientific, and serving on steering committees for Medtronic and Abbott. Goliasch and Bartko have disclosed no relevant financial relationships.
J Am Coll Cardiol Intv. Published online May 18, 2021. Abstract, Editorial
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