Abstract
BackgroundThe PASCAL system is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of this study was to compare the safety and efficacy of the PASCAL to the MitraClip system in a highly selected group of patients with complex primary mitral regurgitation (PMR) defined as effective regurgitant orifice area (MR-EROA) ≥ 0.40 cm2, large flail gap (≥ 5 mm) or width (≥ 7 mm) or Barlow’s disease.Methods38 patients with complex PMR undergoing mitral intervention using PASCAL (n = 22) or MitraClip (n = 16) were enrolled. Primary efficacy endpoints were procedural success and degree of residual MR at discharge. The rate of major adverse events (MAE) according to the Mitral Valve Academic Consortium (MVARC) criteria was chosen as the primary safety endpoint.ResultsPatient collectives did not differ relevantly regarding pertinent baseline parameters. Patients` median age was 83.0 [77.5–85.3] years (PASCAL) and 82.5 [76.5–86.5] years (MitraClip). MR-EROA at baseline was 0.70 [0.68–0.83] cm2 (PASCAL) and 0.70 [0.50–0.90] cm2 (MitraClip), respectively. 3D-echocardiographic morphometry of the mitral valve apparatus revealed no relevant differences between groups. Procedural success was achieved in 95.5% (PASCAL) and 87.5% (MitraClip), respectively. In 86.4% of the patients a residual MR grade ≤ 1 + was achieved with PASCAL whereas reduction to MR grade ≤ 1 + with MitraClip was achieved in 62.5%. Neither procedure time number of implanted devices, nor transmitral gradient differed significantly. No periprocedural MAE according to MVARC occured.ConclusionIn this highly selected patient group with complex PMR both systems exhibited equal procedural safety. MitraClip and PASCAL reduced qualitative and semi-quantitative parameters of MR to an at least comparable extent.Graphic abstract
Highlights
The EVEREST II trial showed that edge-to-edge transcatheter mitral valve repair (TMVR) with the MitraClip system reduces mitral regurgitation less effectively than mitral valve surgery in a patient cohort with low surgical risk and a predominance of primary mitral regurgitation (PMR) [1]
A realworld study with over 300 patients recently accepted for publication confirms promising results with high procedural success rates and safety for the PASCAL device while achieving a similar effectiveness in a cohort of patients of whom one third presented with PMR [5]
38 patients with primary mitral regurgitation were treated with percutaneous edge-to-edge mitral valve repair between August 2018 and April 2020. 22 patients received a PASCAL device and 16 patients underwent a MitraClip intervention (12 cases treated with the XTR-device, 2 cases treated with the NTR-device and 2 cases treated with a combination of both MitraClip devices)
Summary
The EVEREST II trial showed that edge-to-edge transcatheter mitral valve repair (TMVR) with the MitraClip system reduces mitral regurgitation less effectively than mitral valve surgery in a patient cohort with low surgical risk and a predominance of primary mitral regurgitation (PMR) [1]. The trial revealed that, while mortality and symptomatic improvement were similar after a 5-year follow-up, TMVR was associated with higher rates of residual/recurrent MR and mitral valve reinterventions [1]. Based on these findings surgery currently is considered the gold standard for MV repair in PMR in the absence of an increased perioperative risk and the advance of transcatheter mitral therapies will be critically dependent on achieving optimal procedural results even in patients with complex pathologies [2]. MitraClip and PASCAL reduced qualitative and semi-quantitative parameters of MR to an at least comparable extent
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