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  • PASCAL, MitraClip Show Similar Safety, Clinical Outcomes in Patients with Moderate MR – German Study

    Major adverse events (MAE) and procedural success rates were not significantly different between patients who underwent mitral valve transcatheter edge-to-edge repair (TEER) with the PASCAL or MitraClip devices, a new study shows.

    However, patients were less likely to have post-procedure elevated transmitral gradient and moderate mitral regurgitation (MR) when they were treated with PASCAL, suggesting that PASCAL might have different long-term outcomes, the study concludes.

    These data were reported by Victor Mauri, MD, of the University of Cologne, Germany, and colleagues in a manuscript published Wednesday online in JACC: Cardiovascular Interventions.

    Many patients with MR do not undergo surgery because of common risks, such as advanced age and relevant comorbidities. TEER has replaced much of the use of mitral valve surgery in patients with higher surgical risk. The MitraClip system (Abbott Vascular) has been used in more than 150,000 patients and is approved for both degenerative and functional MR, while the PASCAL system (Edwards Lifesciences) was approved by the U.S. Food and Drug Administration in September for degenerative MR.

    In a previous study, these investigators reported procedural and short-term outcomes in a cohort of PASCAL patients after the device received the CE mark in 2019. The present study aimed to compare this cohort with patients who received the MitraClip procedure using propensity-score matching.

    Age, sex, left ventricular ejection fraction, New York Heart Association (NYHA) functional class, MR etiology, left ventricular end-diastolic diameter, left atrial volume index, and vena contracta width were included in the matching criteria. The study investigated 307 PASCAL (mean age = 77.0 ± 9.6 years, 42.3% female, NYHA functional class III or IV = 86.0%)) and 307 MitraClip (mean age = 77.1 ± 8.5, 42.0% female, NYHA functional class III or IV = 93.1%patients. The PASCAL patients underwent the procedure at  10 sites in Germany between February and December 2019; the MitraClip patients were treated at three of those same 10 sites between 2010 and 2018.

    The greatest percentage of comorbidities included arterial hypertension, coronary artery disease, atrial fibrillation and renal disease. All patients were experiencing moderate-to-severe or severe MR at baseline. The rate of MAE was the primary safety endpoint, and technical success and degree of residual MR at discharge were the primary efficacy endpoints.

    Technical success was achieved in 97.0% of patients in the PASCAL group and 98.0% the MitraClip group (P = 0.624). Both groups also had similar rates of MR ≤ 2+ at discharge (PASCAL = 93.8% vs MitraClip = 92.4%; P = 0.527). More patients in the PASCAL group exhibited MR ≤ 1+ (70.5% vs 56.6%; P < 0.001). The MitraClip group experienced significantly higher postprocedural mean gradient (3.3 ± 1.5 mm Hg vs 3.9 ± 1.7 mm Hg; P < 0.001). The PASCAL and MitraClip groups had similar all-cause mortality and MAE rates at 30 days (mortality = 1.7% vs 3.3%; P = 0.299; MAE = 3.9% vs 5.2%; P = 0.562).

    The investigators noted that even though only three of the 10 participating sites contributed patients to the MitraClip group, it is highly unlikely that this caused bias because of the matching baseline characteristics in both groups. The authors concluded that both PASCAL and MitraClip systems have high technical and clinical safety, and overall, PASCAL patients achieved greater MR reduction rates.

    In an accompanying editorial, Neil P. Fam MD, MSc, of the University of Toronto, noted that TEER is widely available and reliable for patients with severe MR.

    He added that while there was no difference in mortality or MAE between the MitraClip and PASCAL groups, patients in the PASCAL group required fewer devices to successfully reduce MR and had more efficient MR reduction overall.

    “Previous cohort studies have suggested a similar advantage of PASCAL over MitraClip with respect to MR reduction, durability and mitral gradients but were limited by small sample size,” said the editorialist, referring to studies such as the CLASP IID randomized trial, where PASCAL showed better durability than MitraClip at the 6-month follow-up.

    Fam also listed a major limitation of the study. The PASCAL P10 device was compared mostly with the first-generation MitraClip NT  or second-generation MitraClip NTR device, as only 12 patients received the third-generation MitraClip XTR device with longer clip arms. The editorialist also said that clinical and echocardiographic follow-ups can easily be incomplete in these types of studies.

    “Detailed follow-up of the CLASP IID/IIF studies and larger real-world experience will further refine these device strategies,” Fam concluded.

    Sources:

    Mauri V, Sugiura A, Spieker M, et al. Early Outcomes of 2 Mitral Valve Transcatheter Leaflet Approximation Devices. JACC Cardiovasc Interv. 2022 Nov 30 (Article in press).

    Fam NP. A Tale of Two TEERs: The Toolbox Expands. JACC Cardiovasc Interv. 2022 Nov 30 (Article in press).

    Image Credit: Belish – stock.adobe.com

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