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Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience

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Abstract

Aims

To examine the clinical experience and practical use of the PASCAL transcatheter valve repair system (Edwards Lifesciences, Irvine, CA, USA) and to report some of the first clinical results.

Methods and results

A total of 18 consecutive patients with severe, symptomatic mitral regurgitation (MR) were included in this German multicentre registry. All patients underwent clinical, echocardiographic, and laboratory assessment prior to the PASCAL procedure and before hospital discharge. MR was classified as functional in 6 patients, degenerative in 2, and combined in 10. All except one received a single PASCAL implant. The preprocedural severe MR present in all patients was reduced: grade 0 in 4 (22.2%), grade I in 11 (61.1%), grade II in 3 (16.7%). The v-wave was significantly reduced from 31.7 ± 9.5 to 18 ± 7.7 mmHg (p < 0.001). Independent leaflet capture, performed in 4 (22.2%) of the patients, wide clasps, and the 10-mm central spacer are features of the PASCAL device to optimize mitral leaflet repair. There were no periprocedural complications.

Conclusion

PASCAL is a safe and effective mitral valve repair device for the treatment of severe MR. Device-specific features allow valve repair tailored to the individual anatomy of the underlying mitral pathology in each patient.

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Acknowledgements

We thank Elizabeth Martinson, Ph.D., of the KHFI Editorial Office for her editorial assistance.

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Correspondence to Steffen D. Kriechbaum.

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Conflict of interest

HM and LG received speaker honoraria from Abbott Vascular and Edwards Lifesciences. HN received speaker honoraria from Abbott Vascular; none of the other authors have any potential conflict of interest regarding this topic.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional ethics committees of the participating centers and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Kriechbaum, S.D., Boeder, N.F., Gaede, L. et al. Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience. Clin Res Cardiol 109, 549–559 (2020). https://doi.org/10.1007/s00392-019-01538-3

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