Sebastian Barth1, Martina B Hautmann2, Eleni Arvaniti2, Jan Kikec2, Sebastian Kerber2, Michael Zacher3, Philipp Halbfass2, Patrick Ranosch2, Lukas Lehmkuhl4, Borek Foldyna4, Ulrich Lüsebrink5, Karsten Hamm6. 1. Department of Cardiology, Cardiovascular Center Bad Neustadt, Von-Guttenberg-Straße 11, 97616, Bad Neustadt a.d. Saale, Germany. sebastian.barth@campus-nes.de. 2. Department of Cardiology, Cardiovascular Center Bad Neustadt, Von-Guttenberg-Straße 11, 97616, Bad Neustadt a.d. Saale, Germany. 3. Department of Cardiac Surgery, Cardiovascular Center Bad Neustadt, Bad Neustadt a.d. Saale, Germany. 4. Department of Radiology, Cardiovascular Center Bad Neustadt, Bad Neustadt a.d. Saale, Germany. 5. Department of Cardiology, University of Marburg, Marburg, Germany. 6. Department of Cardiology, ANregiomed Klinikum Ansbach, Ansbach, Germany.
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.
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.
Authors: Sebastian Barth; Martina B Hautmann; Sebastian Kerber; Frank Gietzen; Michael Zacher; Philipp Halbfass; Patrick Müller; Anja Schade; Thomas Deneke; Anno Diegeler; Bernhard Schieffer; Karsten Hamm Journal: J Heart Valve Dis Date: 2016-07
Authors: Christian Besler; Thilo Noack; Maximilian von Roeder; Mitsunobu Kitamura; Karl-Patrik Kresoja; Anna Flo Forner; Carmine Bevilacqua; Steffen Desch; Joerg Ender; Michael A Borger; Holger Thiele; Philipp Lurz Journal: EuroIntervention Date: 2020-11-20 Impact factor: 6.534
Authors: Nicolas A Geis; Philipp Schlegel; Markus B Heckmann; Hugo A Katus; Norbert Frey; Patricia Crespo López; Philip W J Raake Journal: ESC Heart Fail Date: 2022-02-15
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