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01-05-2021 | Original Paper

Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device

Authors: Sebastian Barth, Martina B. Hautmann, Eleni Arvaniti, Jan Kikec, Sebastian Kerber, Michael Zacher, Philipp Halbfass, Patrick Ranosch, Lukas Lehmkuhl, Borek Foldyna, Ulrich Lüsebrink, Karsten Hamm

Published in: Clinical Research in Cardiology | Issue 5/2021

Abstract

Aims

To examine the functional and hemodynamic mid-term outcome at 5 months of mitral regurgitation (MR) reduction using the PASCAL repair system.

Methods and results

Between July 2019 and February 2020 31 consecutive patients with MR 3 +/4 + (mean age 77.5 years, all in New York Heart Association (NYHA) class III–IV, STS score 9.1 ± 7.4) underwent MR reduction in our institute using the PASCAL device. 61.3% had a functional, 29.0% a degenerative, and 9.7% a mixed etiology. Successful implantation was achieved in 30/31 (96.8%) patients. 27/31 patients (87.1%) completed 5-month follow-up with clinical, echocardiographic, laboratory and hemodynamic assessment. At 5 months, 70.4% of the patients had MR grade ≤ 1 (p < 0.001). 85.2% were in NYHA class I or II (p < 0.001). Six-minute walk distance improved by 145 m (p = 0.010), Kansas City cardiomyopathy questionnaire and European quality of life 5 dimensions questionnaire (EQ5D) improved by 31 (p < 0.001) and 9 points (p = 0.001), respectively. Mean pulmonary capillary wedge pressure decreased significantly from 22.1 ± 9 mmHg to 17.3 ± 8 mmHg (p = 0.041) and right atrial pressure from 10.3 ± 6 mmHg to 8.0 ± 6 mmHg (p = 0.013) from baseline to 5 months. In addition, propensity score matching showed that PASCAL and MitraClip procedures resulted in equally hemodynamic and functional improvement.

Conclusion

MR reduction of severe MR with the PASCAL device is feasible and safe regardless of etiologies. Mid-term follow-up at 5 months showed a sustained MR reduction, improvement of exercise capacity, quality of life, proBNP levels and hemodynamics regarding pulmonary capillary wedge pressure and right atrial pressure.

Graphic abstract

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Title: Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device
Authors: Sebastian Barth
Martina B. Hautmann
Eleni Arvaniti
Jan Kikec
Sebastian Kerber
Michael Zacher
Philipp Halbfass
Patrick Ranosch
Lukas Lehmkuhl
Borek Foldyna
Ulrich Lüsebrink
Karsten Hamm
Publication date: 01-05-2021
Publisher: Springer Berlin Heidelberg
Published in: Clinical Research in Cardiology / Issue 5/2021
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-020-01733-7

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