PMID- 32845361
OWN - NLM
STAT- MEDLINE
DCOM- 20211119
LR  - 20211119
IS  - 1861-0692 (Electronic)
IS  - 1861-0684 (Linking)
VI  - 110
IP  - 5
DP  - 2021 May
TI  - Mid-term hemodynamic and functional results after transcatheter mitral valve 
      leaflet repair with the new PASCAL device.
PG  - 628-639
LID - 10.1007/s00392-020-01733-7 [doi]
AB  - 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.
FAU - Barth, Sebastian
AU  - Barth S
AUID- ORCID: 0000-0001-9549-3503
AD  - Department of Cardiology, Cardiovascular Center Bad Neustadt, 
      Von-Guttenberg-Strasse 11, 97616, Bad Neustadt a.d. Saale, Germany. 
      sebastian.barth@campus-nes.de.
FAU - Hautmann, Martina B
AU  - Hautmann MB
AD  - Department of Cardiology, Cardiovascular Center Bad Neustadt, 
      Von-Guttenberg-Strasse 11, 97616, Bad Neustadt a.d. Saale, Germany.
FAU - Arvaniti, Eleni
AU  - Arvaniti E
AD  - Department of Cardiology, Cardiovascular Center Bad Neustadt, 
      Von-Guttenberg-Strasse 11, 97616, Bad Neustadt a.d. Saale, Germany.
FAU - Kikec, Jan
AU  - Kikec J
AD  - Department of Cardiology, Cardiovascular Center Bad Neustadt, 
      Von-Guttenberg-Strasse 11, 97616, Bad Neustadt a.d. Saale, Germany.
FAU - Kerber, Sebastian
AU  - Kerber S
AD  - Department of Cardiology, Cardiovascular Center Bad Neustadt, 
      Von-Guttenberg-Strasse 11, 97616, Bad Neustadt a.d. Saale, Germany.
FAU - Zacher, Michael
AU  - Zacher M
AD  - Department of Cardiac Surgery, Cardiovascular Center Bad Neustadt, Bad Neustadt 
      a.d. Saale, Germany.
FAU - Halbfass, Philipp
AU  - Halbfass P
AD  - Department of Cardiology, Cardiovascular Center Bad Neustadt, 
      Von-Guttenberg-Strasse 11, 97616, Bad Neustadt a.d. Saale, Germany.
FAU - Ranosch, Patrick
AU  - Ranosch P
AD  - Department of Cardiology, Cardiovascular Center Bad Neustadt, 
      Von-Guttenberg-Strasse 11, 97616, Bad Neustadt a.d. Saale, Germany.
FAU - Lehmkuhl, Lukas
AU  - Lehmkuhl L
AD  - Department of Radiology, Cardiovascular Center Bad Neustadt, Bad Neustadt a.d. 
      Saale, Germany.
FAU - Foldyna, Borek
AU  - Foldyna B
AD  - Department of Radiology, Cardiovascular Center Bad Neustadt, Bad Neustadt a.d. 
      Saale, Germany.
FAU - Lusebrink, Ulrich
AU  - Lusebrink U
AD  - Department of Cardiology, University of Marburg, Marburg, Germany.
FAU - Hamm, Karsten
AU  - Hamm K
AD  - Department of Cardiology, ANregiomed Klinikum Ansbach, Ansbach, Germany.
LA  - eng
PT  - Journal Article
DEP - 20200826
PL  - Germany
TA  - Clin Res Cardiol
JT  - Clinical research in cardiology : official journal of the German Cardiac Society
JID - 101264123
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Arterial Pressure/physiology
MH  - Cardiac Catheterization/*methods
MH  - Exercise Tolerance
MH  - Female
MH  - Follow-Up Studies
MH  - Heart Valve Prosthesis
MH  - Heart Valve Prosthesis Implantation/instrumentation/*methods
MH  - Hemodynamics
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mitral Valve/*surgery
MH  - Mitral Valve Insufficiency/*surgery
MH  - Prosthesis Design
MH  - Pulmonary Wedge Pressure/physiology
MH  - Quality of Life
MH  - Surveys and Questionnaires
OTO - NOTNLM
OT  - Mitral regurgitation
OT  - PASCAL-system
OT  - Transcatheter mitral
OT  - Valve repair
EDAT- 2020/08/28 06:00
MHDA- 2021/11/20 06:00
CRDT- 2020/08/27 06:00
PHST- 2020/07/02 00:00 [received]
PHST- 2020/08/12 00:00 [accepted]
PHST- 2020/08/28 06:00 [pubmed]
PHST- 2021/11/20 06:00 [medline]
PHST- 2020/08/27 06:00 [entrez]
AID - 10.1007/s00392-020-01733-7 [pii]
AID - 10.1007/s00392-020-01733-7 [doi]
PST - ppublish
SO  - Clin Res Cardiol. 2021 May;110(5):628-639. doi: 10.1007/s00392-020-01733-7. Epub 
      2020 Aug 26.