Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience
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...
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| Veröffentlicht in: | Clinical research in cardiology 2020-05, Vol.109 (5), p.549-559 |
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| creator | Kriechbaum, Steffen D. Boeder, Niklas F. Gaede, Luise Arnold, Martin Vigelius-Rauch, Ursula Roth, Peter Sander, Michael Böning, Andreas Bayer, Matthias Elsässer, Albrecht Möllmann, Helge Hamm, Christian W. Nef, Holger M. |
| description | 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
|
| doi_str_mv | 10.1007/s00392-019-01538-3 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2281108638</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2281108638</sourcerecordid><originalsourceid>FETCH-LOGICAL-c375t-5e8c39b90cc8a9637fded339f82f35dabc8d546d0e6aef16911961353f50864f3</originalsourceid><addsrcrecordid>eNp9kU1P3DAQhi1UVD7aP8ChstQLlxQ7E2ft3hACWgkEEu3Z8jrjEuQk27HDdv89pkup1EMP1liaZ94Z6WHsSIpPUojFSRICTF0JacpToCvYYftSt7ISranfvP51s8cOUnoQQkkBzVu2B7JR0ki1z-i6z-Qif3TxEXlEFyJmTrhyPfF1n-95vkc-4prfnt6dnV7xtEkZh88cHcVNAV2s1hPFjncuOx5oGrjjl0iDG_kwx9x7HDMhx18rpB5Hj-_YbnAx4fuXesi-X5x_O_tSXd1cfi0rKg8LlSuF2oNZGuG9dqaFReiwAzBB1wFU55Zed6ppO4GtwyBbI6VpJSgISui2CXDIjre5K5p-zpiyHfrkMUY34jQnW9dayoKCLujHf9CHaaaxXPdMibok16JQ9ZbyNKVEGOyK-sHRxkphn43YrRFbjNjfRiyUoQ8v0fNywO515I-CAsAWSKU1_kD6u_s_sU-dIpYL</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2280219620</pqid></control><display><type>article</type><title>Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Kriechbaum, Steffen D. ; Boeder, Niklas F. ; Gaede, Luise ; Arnold, Martin ; Vigelius-Rauch, Ursula ; Roth, Peter ; Sander, Michael ; Böning, Andreas ; Bayer, Matthias ; Elsässer, Albrecht ; Möllmann, Helge ; Hamm, Christian W. ; Nef, Holger M.</creator><creatorcontrib>Kriechbaum, Steffen D. ; Boeder, Niklas F. ; Gaede, Luise ; Arnold, Martin ; Vigelius-Rauch, Ursula ; Roth, Peter ; Sander, Michael ; Böning, Andreas ; Bayer, Matthias ; Elsässer, Albrecht ; Möllmann, Helge ; Hamm, Christian W. ; Nef, Holger M.</creatorcontrib><description>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.
Graphic abstract</description><identifier>ISSN: 1861-0684</identifier><identifier>EISSN: 1861-0692</identifier><identifier>DOI: 10.1007/s00392-019-01538-3</identifier><identifier>PMID: 31451915</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Aged ; Aged, 80 and over ; Cardiac Catheterization - instrumentation ; Cardiac Catheterization - methods ; Cardiac Catheters ; Cardiology ; Catheters ; Cohort Studies ; Complications ; Equipment Design ; Fasteners ; Female ; Germany ; Heart Valve Prosthesis Implantation - instrumentation ; Heart Valve Prosthesis Implantation - methods ; Heart valves ; Humans ; Male ; Medicine ; Medicine & Public Health ; Mitral valve ; Mitral Valve Insufficiency - diagnostic imaging ; Mitral Valve Insufficiency - surgery ; Original Paper ; Patients ; Registries ; Regurgitation ; Repair ; Treatment Outcome</subject><ispartof>Clinical research in cardiology, 2020-05, Vol.109 (5), p.549-559</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2019</rights><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2019.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-5e8c39b90cc8a9637fded339f82f35dabc8d546d0e6aef16911961353f50864f3</citedby><cites>FETCH-LOGICAL-c375t-5e8c39b90cc8a9637fded339f82f35dabc8d546d0e6aef16911961353f50864f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00392-019-01538-3$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00392-019-01538-3$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,41467,42536,51297</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31451915$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kriechbaum, Steffen D.</creatorcontrib><creatorcontrib>Boeder, Niklas F.</creatorcontrib><creatorcontrib>Gaede, Luise</creatorcontrib><creatorcontrib>Arnold, Martin</creatorcontrib><creatorcontrib>Vigelius-Rauch, Ursula</creatorcontrib><creatorcontrib>Roth, Peter</creatorcontrib><creatorcontrib>Sander, Michael</creatorcontrib><creatorcontrib>Böning, Andreas</creatorcontrib><creatorcontrib>Bayer, Matthias</creatorcontrib><creatorcontrib>Elsässer, Albrecht</creatorcontrib><creatorcontrib>Möllmann, Helge</creatorcontrib><creatorcontrib>Hamm, Christian W.</creatorcontrib><creatorcontrib>Nef, Holger M.</creatorcontrib><title>Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience</title><title>Clinical research in cardiology</title><addtitle>Clin Res Cardiol</addtitle><addtitle>Clin Res Cardiol</addtitle><description>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.
Graphic abstract</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Cardiac Catheterization - instrumentation</subject><subject>Cardiac Catheterization - methods</subject><subject>Cardiac Catheters</subject><subject>Cardiology</subject><subject>Catheters</subject><subject>Cohort Studies</subject><subject>Complications</subject><subject>Equipment Design</subject><subject>Fasteners</subject><subject>Female</subject><subject>Germany</subject><subject>Heart Valve Prosthesis Implantation - instrumentation</subject><subject>Heart Valve Prosthesis Implantation - methods</subject><subject>Heart valves</subject><subject>Humans</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Mitral valve</subject><subject>Mitral Valve Insufficiency - diagnostic imaging</subject><subject>Mitral Valve Insufficiency - surgery</subject><subject>Original Paper</subject><subject>Patients</subject><subject>Registries</subject><subject>Regurgitation</subject><subject>Repair</subject><subject>Treatment Outcome</subject><issn>1861-0684</issn><issn>1861-0692</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kU1P3DAQhi1UVD7aP8ChstQLlxQ7E2ft3hACWgkEEu3Z8jrjEuQk27HDdv89pkup1EMP1liaZ94Z6WHsSIpPUojFSRICTF0JacpToCvYYftSt7ISranfvP51s8cOUnoQQkkBzVu2B7JR0ki1z-i6z-Qif3TxEXlEFyJmTrhyPfF1n-95vkc-4prfnt6dnV7xtEkZh88cHcVNAV2s1hPFjncuOx5oGrjjl0iDG_kwx9x7HDMhx18rpB5Hj-_YbnAx4fuXesi-X5x_O_tSXd1cfi0rKg8LlSuF2oNZGuG9dqaFReiwAzBB1wFU55Zed6ppO4GtwyBbI6VpJSgISui2CXDIjre5K5p-zpiyHfrkMUY34jQnW9dayoKCLujHf9CHaaaxXPdMibok16JQ9ZbyNKVEGOyK-sHRxkphn43YrRFbjNjfRiyUoQ8v0fNywO515I-CAsAWSKU1_kD6u_s_sU-dIpYL</recordid><startdate>20200501</startdate><enddate>20200501</enddate><creator>Kriechbaum, Steffen D.</creator><creator>Boeder, Niklas F.</creator><creator>Gaede, Luise</creator><creator>Arnold, Martin</creator><creator>Vigelius-Rauch, Ursula</creator><creator>Roth, Peter</creator><creator>Sander, Michael</creator><creator>Böning, Andreas</creator><creator>Bayer, Matthias</creator><creator>Elsässer, Albrecht</creator><creator>Möllmann, Helge</creator><creator>Hamm, Christian W.</creator><creator>Nef, Holger M.</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><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></search><sort><creationdate>20200501</creationdate><title>Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience</title><author>Kriechbaum, Steffen D. ; Boeder, Niklas F. ; Gaede, Luise ; Arnold, Martin ; Vigelius-Rauch, Ursula ; Roth, Peter ; Sander, Michael ; Böning, Andreas ; Bayer, Matthias ; Elsässer, Albrecht ; Möllmann, Helge ; Hamm, Christian W. ; Nef, Holger M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-5e8c39b90cc8a9637fded339f82f35dabc8d546d0e6aef16911961353f50864f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Cardiac Catheterization - instrumentation</topic><topic>Cardiac Catheterization - methods</topic><topic>Cardiac Catheters</topic><topic>Cardiology</topic><topic>Catheters</topic><topic>Cohort Studies</topic><topic>Complications</topic><topic>Equipment Design</topic><topic>Fasteners</topic><topic>Female</topic><topic>Germany</topic><topic>Heart Valve Prosthesis Implantation - instrumentation</topic><topic>Heart Valve Prosthesis Implantation - methods</topic><topic>Heart valves</topic><topic>Humans</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Mitral valve</topic><topic>Mitral Valve Insufficiency - diagnostic imaging</topic><topic>Mitral Valve Insufficiency - surgery</topic><topic>Original Paper</topic><topic>Patients</topic><topic>Registries</topic><topic>Regurgitation</topic><topic>Repair</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kriechbaum, Steffen D.</creatorcontrib><creatorcontrib>Boeder, Niklas F.</creatorcontrib><creatorcontrib>Gaede, Luise</creatorcontrib><creatorcontrib>Arnold, Martin</creatorcontrib><creatorcontrib>Vigelius-Rauch, Ursula</creatorcontrib><creatorcontrib>Roth, Peter</creatorcontrib><creatorcontrib>Sander, Michael</creatorcontrib><creatorcontrib>Böning, Andreas</creatorcontrib><creatorcontrib>Bayer, Matthias</creatorcontrib><creatorcontrib>Elsässer, Albrecht</creatorcontrib><creatorcontrib>Möllmann, Helge</creatorcontrib><creatorcontrib>Hamm, Christian W.</creatorcontrib><creatorcontrib>Nef, Holger M.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><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>Kriechbaum, Steffen D.</au><au>Boeder, Niklas F.</au><au>Gaede, Luise</au><au>Arnold, Martin</au><au>Vigelius-Rauch, Ursula</au><au>Roth, Peter</au><au>Sander, Michael</au><au>Böning, Andreas</au><au>Bayer, Matthias</au><au>Elsässer, Albrecht</au><au>Möllmann, Helge</au><au>Hamm, Christian W.</au><au>Nef, Holger M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience</atitle><jtitle>Clinical research in cardiology</jtitle><stitle>Clin Res Cardiol</stitle><addtitle>Clin Res Cardiol</addtitle><date>2020-05-01</date><risdate>2020</risdate><volume>109</volume><issue>5</issue><spage>549</spage><epage>559</epage><pages>549-559</pages><issn>1861-0684</issn><eissn>1861-0692</eissn><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.
Graphic abstract</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>31451915</pmid><doi>10.1007/s00392-019-01538-3</doi><tpages>11</tpages></addata></record> |
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| ispartof | Clinical research in cardiology, 2020-05, Vol.109 (5), p.549-559 |
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| subjects | Aged Aged, 80 and over Cardiac Catheterization - instrumentation Cardiac Catheterization - methods Cardiac Catheters Cardiology Catheters Cohort Studies Complications Equipment Design Fasteners Female Germany Heart Valve Prosthesis Implantation - instrumentation Heart Valve Prosthesis Implantation - methods Heart valves Humans Male Medicine Medicine & Public Health Mitral valve Mitral Valve Insufficiency - diagnostic imaging Mitral Valve Insufficiency - surgery Original Paper Patients Registries Regurgitation Repair Treatment Outcome |
| title | Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience |
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