Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device
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 (...
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| Veröffentlicht in: | Clinical research in cardiology 2021-05, Vol.110 (5), p.628-639 |
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| creator | Barth, Sebastian Hautmann, Martina B. Arvaniti, Eleni Kikec, Jan Kerber, Sebastian Zacher, Michael Halbfass, Philipp Ranosch, Patrick Lehmkuhl, Lukas Foldyna, Borek Lüsebrink, Ulrich Hamm, Karsten |
| description | 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
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| doi_str_mv | 10.1007/s00392-020-01733-7 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2437397083</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2522237294</sourcerecordid><originalsourceid>FETCH-LOGICAL-c375t-4fea49d55cc0770efd1af86593206058f5ae587f362e6ef8036cb223a151eb363</originalsourceid><addsrcrecordid>eNp9kcFOHSEUhkljU63tC3TRkLhxM-0BBphZGtPaJhpNbNeEyxx6MczMFZhrfHux19rEhSs44fv_E_IR8onBFwagv2YA0fMGODTAtBCNfkMOWKdYA6rne8_3rt0n73O-AZAMRPuO7AvetVIodkC2F2FoCqaRrnGch_vJjsFROw3UL5MrYZ5spAnzEkum1leSlmSn7GxZ4-M0hjpHurVxizSi9RFLDWxsSPQulDWtHJ3wjl6dXJ-enNMBt8HhB_LW25jx49N5SH5___br9Edzfnn2s2KNE1qWpvVo236Q0jnQGtAPzPpOyV5wUCA7Ly3KTnuhOCr0HQjlVpwLyyTDlVDikBzvejdpvl0wFzOG7DBGO-G8ZMNboUWvoRMVPXqB3sxLqt-vlOS1VPO-rRTfUS7NOSf0ZpPCaNO9YWAerZidFVOtmL9WjK6hz0_Vy2rE4TnyT0MFxA7I9Wn6g-n_7ldqHwBrPZfx</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2522237294</pqid></control><display><type>article</type><title>Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device</title><source>SpringerLink Journals</source><creator>Barth, Sebastian ; Hautmann, Martina B. ; Arvaniti, Eleni ; Kikec, Jan ; Kerber, Sebastian ; Zacher, Michael ; Halbfass, Philipp ; Ranosch, Patrick ; Lehmkuhl, Lukas ; Foldyna, Borek ; Lüsebrink, Ulrich ; Hamm, Karsten</creator><creatorcontrib>Barth, Sebastian ; Hautmann, Martina B. ; Arvaniti, Eleni ; Kikec, Jan ; Kerber, Sebastian ; Zacher, Michael ; Halbfass, Philipp ; Ranosch, Patrick ; Lehmkuhl, Lukas ; Foldyna, Borek ; Lüsebrink, Ulrich ; Hamm, Karsten</creatorcontrib><description>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</description><identifier>ISSN: 1861-0684</identifier><identifier>EISSN: 1861-0692</identifier><identifier>DOI: 10.1007/s00392-020-01733-7</identifier><identifier>PMID: 32845361</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Capillary pressure ; Cardiology ; Cardiomyopathy ; Etiology ; Heart valves ; Hemodynamics ; Medicine ; Medicine & Public Health ; Mitral valve ; Original Paper ; Pressure ; Quality of life ; Questionnaires ; Regurgitation ; Valve leaflets</subject><ispartof>Clinical research in cardiology, 2021-05, Vol.110 (5), p.628-639</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2020</rights><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2020.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-4fea49d55cc0770efd1af86593206058f5ae587f362e6ef8036cb223a151eb363</citedby><cites>FETCH-LOGICAL-c375t-4fea49d55cc0770efd1af86593206058f5ae587f362e6ef8036cb223a151eb363</cites><orcidid>0000-0001-9549-3503</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00392-020-01733-7$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00392-020-01733-7$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32845361$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Barth, Sebastian</creatorcontrib><creatorcontrib>Hautmann, Martina B.</creatorcontrib><creatorcontrib>Arvaniti, Eleni</creatorcontrib><creatorcontrib>Kikec, Jan</creatorcontrib><creatorcontrib>Kerber, Sebastian</creatorcontrib><creatorcontrib>Zacher, Michael</creatorcontrib><creatorcontrib>Halbfass, Philipp</creatorcontrib><creatorcontrib>Ranosch, Patrick</creatorcontrib><creatorcontrib>Lehmkuhl, Lukas</creatorcontrib><creatorcontrib>Foldyna, Borek</creatorcontrib><creatorcontrib>Lüsebrink, Ulrich</creatorcontrib><creatorcontrib>Hamm, Karsten</creatorcontrib><title>Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device</title><title>Clinical research in cardiology</title><addtitle>Clin Res Cardiol</addtitle><addtitle>Clin Res Cardiol</addtitle><description>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</description><subject>Capillary pressure</subject><subject>Cardiology</subject><subject>Cardiomyopathy</subject><subject>Etiology</subject><subject>Heart valves</subject><subject>Hemodynamics</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Mitral valve</subject><subject>Original Paper</subject><subject>Pressure</subject><subject>Quality of life</subject><subject>Questionnaires</subject><subject>Regurgitation</subject><subject>Valve leaflets</subject><issn>1861-0684</issn><issn>1861-0692</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>BENPR</sourceid><recordid>eNp9kcFOHSEUhkljU63tC3TRkLhxM-0BBphZGtPaJhpNbNeEyxx6MczMFZhrfHux19rEhSs44fv_E_IR8onBFwagv2YA0fMGODTAtBCNfkMOWKdYA6rne8_3rt0n73O-AZAMRPuO7AvetVIodkC2F2FoCqaRrnGch_vJjsFROw3UL5MrYZ5spAnzEkum1leSlmSn7GxZ4-M0hjpHurVxizSi9RFLDWxsSPQulDWtHJ3wjl6dXJ-enNMBt8HhB_LW25jx49N5SH5___br9Edzfnn2s2KNE1qWpvVo236Q0jnQGtAPzPpOyV5wUCA7Ly3KTnuhOCr0HQjlVpwLyyTDlVDikBzvejdpvl0wFzOG7DBGO-G8ZMNboUWvoRMVPXqB3sxLqt-vlOS1VPO-rRTfUS7NOSf0ZpPCaNO9YWAerZidFVOtmL9WjK6hz0_Vy2rE4TnyT0MFxA7I9Wn6g-n_7ldqHwBrPZfx</recordid><startdate>20210501</startdate><enddate>20210501</enddate><creator>Barth, Sebastian</creator><creator>Hautmann, Martina B.</creator><creator>Arvaniti, Eleni</creator><creator>Kikec, Jan</creator><creator>Kerber, Sebastian</creator><creator>Zacher, Michael</creator><creator>Halbfass, Philipp</creator><creator>Ranosch, Patrick</creator><creator>Lehmkuhl, Lukas</creator><creator>Foldyna, Borek</creator><creator>Lüsebrink, Ulrich</creator><creator>Hamm, Karsten</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7Z</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-9549-3503</orcidid></search><sort><creationdate>20210501</creationdate><title>Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device</title><author>Barth, Sebastian ; Hautmann, Martina B. ; Arvaniti, Eleni ; Kikec, Jan ; Kerber, Sebastian ; Zacher, Michael ; Halbfass, Philipp ; Ranosch, Patrick ; Lehmkuhl, Lukas ; Foldyna, Borek ; Lüsebrink, Ulrich ; Hamm, Karsten</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-4fea49d55cc0770efd1af86593206058f5ae587f362e6ef8036cb223a151eb363</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Capillary pressure</topic><topic>Cardiology</topic><topic>Cardiomyopathy</topic><topic>Etiology</topic><topic>Heart valves</topic><topic>Hemodynamics</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Mitral valve</topic><topic>Original Paper</topic><topic>Pressure</topic><topic>Quality of life</topic><topic>Questionnaires</topic><topic>Regurgitation</topic><topic>Valve leaflets</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Barth, Sebastian</creatorcontrib><creatorcontrib>Hautmann, Martina B.</creatorcontrib><creatorcontrib>Arvaniti, Eleni</creatorcontrib><creatorcontrib>Kikec, Jan</creatorcontrib><creatorcontrib>Kerber, Sebastian</creatorcontrib><creatorcontrib>Zacher, Michael</creatorcontrib><creatorcontrib>Halbfass, Philipp</creatorcontrib><creatorcontrib>Ranosch, Patrick</creatorcontrib><creatorcontrib>Lehmkuhl, Lukas</creatorcontrib><creatorcontrib>Foldyna, Borek</creatorcontrib><creatorcontrib>Lüsebrink, Ulrich</creatorcontrib><creatorcontrib>Hamm, Karsten</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biochemistry Abstracts 1</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical research in cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Barth, Sebastian</au><au>Hautmann, Martina B.</au><au>Arvaniti, Eleni</au><au>Kikec, Jan</au><au>Kerber, Sebastian</au><au>Zacher, Michael</au><au>Halbfass, Philipp</au><au>Ranosch, Patrick</au><au>Lehmkuhl, Lukas</au><au>Foldyna, Borek</au><au>Lüsebrink, Ulrich</au><au>Hamm, Karsten</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device</atitle><jtitle>Clinical research in cardiology</jtitle><stitle>Clin Res Cardiol</stitle><addtitle>Clin Res Cardiol</addtitle><date>2021-05-01</date><risdate>2021</risdate><volume>110</volume><issue>5</issue><spage>628</spage><epage>639</epage><pages>628-639</pages><issn>1861-0684</issn><eissn>1861-0692</eissn><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</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>32845361</pmid><doi>10.1007/s00392-020-01733-7</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0001-9549-3503</orcidid></addata></record> |
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| ispartof | Clinical research in cardiology, 2021-05, Vol.110 (5), p.628-639 |
| issn | 1861-0684 1861-0692 |
| language | eng |
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| source | SpringerLink Journals |
| subjects | Capillary pressure Cardiology Cardiomyopathy Etiology Heart valves Hemodynamics Medicine Medicine & Public Health Mitral valve Original Paper Pressure Quality of life Questionnaires Regurgitation Valve leaflets |
| title | Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device |
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