Pre-procedural fit-testing of TAVR valves using parametric modeling and 3D printing
Successful transcatheter aortic valve replacement (TAVR) requires an understanding of how a prosthetic valve will interact with a patient's anatomy in advance of surgical deployment. To improve this understanding, we developed a benchtop workflow that allows for testing of physical interactions...
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| Veröffentlicht in: | Journal of cardiovascular computed tomography 2019-01, Vol.13 (1), p.21-30 |
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| creator | Hosny, Ahmed Dilley, Joshua D. Kelil, Tatiana Mathur, Moses Dean, Mason N. Weaver, James C. Ripley, Beth |
| description | Successful transcatheter aortic valve replacement (TAVR) requires an understanding of how a prosthetic valve will interact with a patient's anatomy in advance of surgical deployment. To improve this understanding, we developed a benchtop workflow that allows for testing of physical interactions between prosthetic valves and patient-specific aortic root anatomy, including calcified leaflets, prior to actual prosthetic valve placement.
This was a retrospective study of 30 patients who underwent TAVR at a single high volume center. By design, the dataset contained 15 patients with a successful annular seal (defined by an absence of paravalvular leaks) and 15 patients with a sub-optimal seal (presence of paravalvular leaks) on post-procedure transthoracic echocardiogram (TTE). Patients received either a balloon-expandable (Edwards Sapien or Sapien XT, n = 15), or a self-expanding (Medtronic CoreValve or Core Evolut, n = 14, St. Jude Portico, n = 1) valve. Pre-procedural computed tomography (CT) angiograms, parametric geometry modeling, and multi-material 3D printing were utilized to create flexible aortic root physical models, including displaceable calcified valve leaflets. A 3D printed adjustable sizing device was then positioned in the aortic root models and sequentially opened to larger valve sizes, progressively flattening the calcified leaflets against the aortic wall. Optimal valve size and fit were determined by visual inspection and quantitative pressure mapping of interactions between the sizer and models.
Benchtop-predicted “best fit” valve size showed a statistically significant correlation with gold standard CT measurements of the average annulus diameter (n = 30, p |
| doi_str_mv | 10.1016/j.jcct.2018.09.007 |
| format | Article |
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This was a retrospective study of 30 patients who underwent TAVR at a single high volume center. By design, the dataset contained 15 patients with a successful annular seal (defined by an absence of paravalvular leaks) and 15 patients with a sub-optimal seal (presence of paravalvular leaks) on post-procedure transthoracic echocardiogram (TTE). Patients received either a balloon-expandable (Edwards Sapien or Sapien XT, n = 15), or a self-expanding (Medtronic CoreValve or Core Evolut, n = 14, St. Jude Portico, n = 1) valve. Pre-procedural computed tomography (CT) angiograms, parametric geometry modeling, and multi-material 3D printing were utilized to create flexible aortic root physical models, including displaceable calcified valve leaflets. A 3D printed adjustable sizing device was then positioned in the aortic root models and sequentially opened to larger valve sizes, progressively flattening the calcified leaflets against the aortic wall. Optimal valve size and fit were determined by visual inspection and quantitative pressure mapping of interactions between the sizer and models.
Benchtop-predicted “best fit” valve size showed a statistically significant correlation with gold standard CT measurements of the average annulus diameter (n = 30, p < 0.0001 Wilcoxon matched-pairs signed rank test). Adequateness of seal (presence or absence of paravalvular leak) was correctly predicted in 11/15 (73.3%) patients who received a balloon-expandable valve, and in 9/15 (60%) patients who received a self-expanding valve. Pressure testing provided a physical map of areas with an inadequate seal; these corresponded to areas of paravalvular leak documented by post-procedural transthoracic echocardiography.
We present and demonstrate the potential of a workflow for determining optimal prosthetic valve size that accounts for aortic annular dimensions as well as the active displacement of calcified valve leaflets during prosthetic valve deployment. The workflow's open source framework offers a platform for providing predictive insights into the design and testing of future prosthetic valves.</description><identifier>ISSN: 1934-5925</identifier><identifier>EISSN: 1876-861X</identifier><identifier>DOI: 10.1016/j.jcct.2018.09.007</identifier><identifier>PMID: 30322772</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>3-D printing ; 3D printing ; Additive manufacturing ; Aged ; Aged, 80 and over ; Aortic leaflets ; Aortic stenosis ; Aortic valve ; Aortic Valve - diagnostic imaging ; Aortic Valve - pathology ; Aortic Valve - physiopathology ; Aortic Valve - surgery ; Aortic Valve Insufficiency - diagnostic imaging ; Aortic Valve Insufficiency - etiology ; Aortic Valve Insufficiency - physiopathology ; Aortic Valve Stenosis - diagnosis ; Aortic Valve Stenosis - physiopathology ; Aortic Valve Stenosis - surgery ; Aortography - methods ; Calcifications ; Calcinosis - diagnosis ; Calcinosis - physiopathology ; Calcinosis - surgery ; Clinical Decision-Making ; Computed Tomography Angiography ; Female ; Heart Valve Prosthesis ; Hospitals, High-Volume ; Humans ; Male ; Models, Anatomic ; Models, Cardiovascular ; Multi-material printing ; Parametric modeling ; Patient-Specific Modeling ; Printing, Three-Dimensional ; Prosthesis Design ; Radiographic Image Interpretation, Computer-Assisted ; Retrospective Studies ; Transcatheter Aortic Valve Replacement - adverse effects ; Transcatheter Aortic Valve Replacement - instrumentation ; Treatment Outcome ; Workflow</subject><ispartof>Journal of cardiovascular computed tomography, 2019-01, Vol.13 (1), p.21-30</ispartof><rights>2018</rights><rights>Published by Elsevier Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c422t-f75bbc154dfec66e364b3565a818808828241c7a3149b775fae4e68b2f5524633</citedby><cites>FETCH-LOGICAL-c422t-f75bbc154dfec66e364b3565a818808828241c7a3149b775fae4e68b2f5524633</cites><orcidid>0000-0002-1844-481X ; 0000-0003-4718-3839 ; 0000-0002-5026-6216</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1934592518301722$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30322772$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hosny, Ahmed</creatorcontrib><creatorcontrib>Dilley, Joshua D.</creatorcontrib><creatorcontrib>Kelil, Tatiana</creatorcontrib><creatorcontrib>Mathur, Moses</creatorcontrib><creatorcontrib>Dean, Mason N.</creatorcontrib><creatorcontrib>Weaver, James C.</creatorcontrib><creatorcontrib>Ripley, Beth</creatorcontrib><title>Pre-procedural fit-testing of TAVR valves using parametric modeling and 3D printing</title><title>Journal of cardiovascular computed tomography</title><addtitle>J Cardiovasc Comput Tomogr</addtitle><description>Successful transcatheter aortic valve replacement (TAVR) requires an understanding of how a prosthetic valve will interact with a patient's anatomy in advance of surgical deployment. To improve this understanding, we developed a benchtop workflow that allows for testing of physical interactions between prosthetic valves and patient-specific aortic root anatomy, including calcified leaflets, prior to actual prosthetic valve placement.
This was a retrospective study of 30 patients who underwent TAVR at a single high volume center. By design, the dataset contained 15 patients with a successful annular seal (defined by an absence of paravalvular leaks) and 15 patients with a sub-optimal seal (presence of paravalvular leaks) on post-procedure transthoracic echocardiogram (TTE). Patients received either a balloon-expandable (Edwards Sapien or Sapien XT, n = 15), or a self-expanding (Medtronic CoreValve or Core Evolut, n = 14, St. Jude Portico, n = 1) valve. Pre-procedural computed tomography (CT) angiograms, parametric geometry modeling, and multi-material 3D printing were utilized to create flexible aortic root physical models, including displaceable calcified valve leaflets. A 3D printed adjustable sizing device was then positioned in the aortic root models and sequentially opened to larger valve sizes, progressively flattening the calcified leaflets against the aortic wall. Optimal valve size and fit were determined by visual inspection and quantitative pressure mapping of interactions between the sizer and models.
Benchtop-predicted “best fit” valve size showed a statistically significant correlation with gold standard CT measurements of the average annulus diameter (n = 30, p < 0.0001 Wilcoxon matched-pairs signed rank test). Adequateness of seal (presence or absence of paravalvular leak) was correctly predicted in 11/15 (73.3%) patients who received a balloon-expandable valve, and in 9/15 (60%) patients who received a self-expanding valve. Pressure testing provided a physical map of areas with an inadequate seal; these corresponded to areas of paravalvular leak documented by post-procedural transthoracic echocardiography.
We present and demonstrate the potential of a workflow for determining optimal prosthetic valve size that accounts for aortic annular dimensions as well as the active displacement of calcified valve leaflets during prosthetic valve deployment. The workflow's open source framework offers a platform for providing predictive insights into the design and testing of future prosthetic valves.</description><subject>3-D printing</subject><subject>3D printing</subject><subject>Additive manufacturing</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Aortic leaflets</subject><subject>Aortic stenosis</subject><subject>Aortic valve</subject><subject>Aortic Valve - diagnostic imaging</subject><subject>Aortic Valve - pathology</subject><subject>Aortic Valve - physiopathology</subject><subject>Aortic Valve - surgery</subject><subject>Aortic Valve Insufficiency - diagnostic imaging</subject><subject>Aortic Valve Insufficiency - etiology</subject><subject>Aortic Valve Insufficiency - physiopathology</subject><subject>Aortic Valve Stenosis - diagnosis</subject><subject>Aortic Valve Stenosis - physiopathology</subject><subject>Aortic Valve Stenosis - surgery</subject><subject>Aortography - methods</subject><subject>Calcifications</subject><subject>Calcinosis - diagnosis</subject><subject>Calcinosis - physiopathology</subject><subject>Calcinosis - surgery</subject><subject>Clinical Decision-Making</subject><subject>Computed Tomography Angiography</subject><subject>Female</subject><subject>Heart Valve Prosthesis</subject><subject>Hospitals, High-Volume</subject><subject>Humans</subject><subject>Male</subject><subject>Models, Anatomic</subject><subject>Models, Cardiovascular</subject><subject>Multi-material printing</subject><subject>Parametric modeling</subject><subject>Patient-Specific Modeling</subject><subject>Printing, Three-Dimensional</subject><subject>Prosthesis Design</subject><subject>Radiographic Image Interpretation, Computer-Assisted</subject><subject>Retrospective Studies</subject><subject>Transcatheter Aortic Valve Replacement - adverse effects</subject><subject>Transcatheter Aortic Valve Replacement - instrumentation</subject><subject>Treatment Outcome</subject><subject>Workflow</subject><issn>1934-5925</issn><issn>1876-861X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kElLxEAQhRtRHLc_4EFy9JLYS3oJeBncYUBxw1vT6VSkhyxjdzLgv7fDjB49VVG893j1IXRKcEYwERfLbGntkFFMVIaLDGO5gw6IkiJVgnzsxr1gecoLymfoMIQlxlwSrPbRjGFGqZT0AL08eUhXvrdQjd40Se2GdIAwuO4z6evkdf7-nKxNs4aQjGE6row3LQze2aTtK2imm-mqhF0nK--6yXiM9mrTBDjZziP0dnvzenWfLh7vHq7mi9TmlA5pLXlZWsLzqgYrBDCRl4wLbhRRCitFFc2JlYaRvCil5LWBHIQqac05zQVjR-h8kxv7f42xtG5dsNA0poN-DJoSiiXnquBRSjdS6_sQPNQ6lm2N_9YE6wmmXuoJpp5galzoCDOazrb5Y9lC9Wf5pRcFlxsBxC_XDrwO1kEXWToPMazq3X_5P2nOhLw</recordid><startdate>201901</startdate><enddate>201901</enddate><creator>Hosny, Ahmed</creator><creator>Dilley, Joshua D.</creator><creator>Kelil, Tatiana</creator><creator>Mathur, Moses</creator><creator>Dean, Mason N.</creator><creator>Weaver, James C.</creator><creator>Ripley, Beth</creator><general>Elsevier Inc</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>7X8</scope><orcidid>https://orcid.org/0000-0002-1844-481X</orcidid><orcidid>https://orcid.org/0000-0003-4718-3839</orcidid><orcidid>https://orcid.org/0000-0002-5026-6216</orcidid></search><sort><creationdate>201901</creationdate><title>Pre-procedural fit-testing of TAVR valves using parametric modeling and 3D printing</title><author>Hosny, Ahmed ; Dilley, Joshua D. ; Kelil, Tatiana ; Mathur, Moses ; Dean, Mason N. ; Weaver, James C. ; Ripley, Beth</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c422t-f75bbc154dfec66e364b3565a818808828241c7a3149b775fae4e68b2f5524633</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>3-D printing</topic><topic>3D printing</topic><topic>Additive manufacturing</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Aortic leaflets</topic><topic>Aortic stenosis</topic><topic>Aortic valve</topic><topic>Aortic Valve - diagnostic imaging</topic><topic>Aortic Valve - pathology</topic><topic>Aortic Valve - physiopathology</topic><topic>Aortic Valve - surgery</topic><topic>Aortic Valve Insufficiency - diagnostic imaging</topic><topic>Aortic Valve Insufficiency - etiology</topic><topic>Aortic Valve Insufficiency - physiopathology</topic><topic>Aortic Valve Stenosis - diagnosis</topic><topic>Aortic Valve Stenosis - physiopathology</topic><topic>Aortic Valve Stenosis - surgery</topic><topic>Aortography - methods</topic><topic>Calcifications</topic><topic>Calcinosis - diagnosis</topic><topic>Calcinosis - physiopathology</topic><topic>Calcinosis - surgery</topic><topic>Clinical Decision-Making</topic><topic>Computed Tomography Angiography</topic><topic>Female</topic><topic>Heart Valve Prosthesis</topic><topic>Hospitals, High-Volume</topic><topic>Humans</topic><topic>Male</topic><topic>Models, Anatomic</topic><topic>Models, Cardiovascular</topic><topic>Multi-material printing</topic><topic>Parametric modeling</topic><topic>Patient-Specific Modeling</topic><topic>Printing, Three-Dimensional</topic><topic>Prosthesis Design</topic><topic>Radiographic Image Interpretation, Computer-Assisted</topic><topic>Retrospective Studies</topic><topic>Transcatheter Aortic Valve Replacement - adverse effects</topic><topic>Transcatheter Aortic Valve Replacement - instrumentation</topic><topic>Treatment Outcome</topic><topic>Workflow</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hosny, Ahmed</creatorcontrib><creatorcontrib>Dilley, Joshua D.</creatorcontrib><creatorcontrib>Kelil, Tatiana</creatorcontrib><creatorcontrib>Mathur, Moses</creatorcontrib><creatorcontrib>Dean, Mason N.</creatorcontrib><creatorcontrib>Weaver, James C.</creatorcontrib><creatorcontrib>Ripley, Beth</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of cardiovascular computed tomography</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hosny, Ahmed</au><au>Dilley, Joshua D.</au><au>Kelil, Tatiana</au><au>Mathur, Moses</au><au>Dean, Mason N.</au><au>Weaver, James C.</au><au>Ripley, Beth</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pre-procedural fit-testing of TAVR valves using parametric modeling and 3D printing</atitle><jtitle>Journal of cardiovascular computed tomography</jtitle><addtitle>J Cardiovasc Comput Tomogr</addtitle><date>2019-01</date><risdate>2019</risdate><volume>13</volume><issue>1</issue><spage>21</spage><epage>30</epage><pages>21-30</pages><issn>1934-5925</issn><eissn>1876-861X</eissn><abstract>Successful transcatheter aortic valve replacement (TAVR) requires an understanding of how a prosthetic valve will interact with a patient's anatomy in advance of surgical deployment. To improve this understanding, we developed a benchtop workflow that allows for testing of physical interactions between prosthetic valves and patient-specific aortic root anatomy, including calcified leaflets, prior to actual prosthetic valve placement.
This was a retrospective study of 30 patients who underwent TAVR at a single high volume center. By design, the dataset contained 15 patients with a successful annular seal (defined by an absence of paravalvular leaks) and 15 patients with a sub-optimal seal (presence of paravalvular leaks) on post-procedure transthoracic echocardiogram (TTE). Patients received either a balloon-expandable (Edwards Sapien or Sapien XT, n = 15), or a self-expanding (Medtronic CoreValve or Core Evolut, n = 14, St. Jude Portico, n = 1) valve. Pre-procedural computed tomography (CT) angiograms, parametric geometry modeling, and multi-material 3D printing were utilized to create flexible aortic root physical models, including displaceable calcified valve leaflets. A 3D printed adjustable sizing device was then positioned in the aortic root models and sequentially opened to larger valve sizes, progressively flattening the calcified leaflets against the aortic wall. Optimal valve size and fit were determined by visual inspection and quantitative pressure mapping of interactions between the sizer and models.
Benchtop-predicted “best fit” valve size showed a statistically significant correlation with gold standard CT measurements of the average annulus diameter (n = 30, p < 0.0001 Wilcoxon matched-pairs signed rank test). Adequateness of seal (presence or absence of paravalvular leak) was correctly predicted in 11/15 (73.3%) patients who received a balloon-expandable valve, and in 9/15 (60%) patients who received a self-expanding valve. Pressure testing provided a physical map of areas with an inadequate seal; these corresponded to areas of paravalvular leak documented by post-procedural transthoracic echocardiography.
We present and demonstrate the potential of a workflow for determining optimal prosthetic valve size that accounts for aortic annular dimensions as well as the active displacement of calcified valve leaflets during prosthetic valve deployment. The workflow's open source framework offers a platform for providing predictive insights into the design and testing of future prosthetic valves.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>30322772</pmid><doi>10.1016/j.jcct.2018.09.007</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-1844-481X</orcidid><orcidid>https://orcid.org/0000-0003-4718-3839</orcidid><orcidid>https://orcid.org/0000-0002-5026-6216</orcidid></addata></record> |
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| ispartof | Journal of cardiovascular computed tomography, 2019-01, Vol.13 (1), p.21-30 |
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| subjects | 3-D printing 3D printing Additive manufacturing Aged Aged, 80 and over Aortic leaflets Aortic stenosis Aortic valve Aortic Valve - diagnostic imaging Aortic Valve - pathology Aortic Valve - physiopathology Aortic Valve - surgery Aortic Valve Insufficiency - diagnostic imaging Aortic Valve Insufficiency - etiology Aortic Valve Insufficiency - physiopathology Aortic Valve Stenosis - diagnosis Aortic Valve Stenosis - physiopathology Aortic Valve Stenosis - surgery Aortography - methods Calcifications Calcinosis - diagnosis Calcinosis - physiopathology Calcinosis - surgery Clinical Decision-Making Computed Tomography Angiography Female Heart Valve Prosthesis Hospitals, High-Volume Humans Male Models, Anatomic Models, Cardiovascular Multi-material printing Parametric modeling Patient-Specific Modeling Printing, Three-Dimensional Prosthesis Design Radiographic Image Interpretation, Computer-Assisted Retrospective Studies Transcatheter Aortic Valve Replacement - adverse effects Transcatheter Aortic Valve Replacement - instrumentation Treatment Outcome Workflow |
| title | Pre-procedural fit-testing of TAVR valves using parametric modeling and 3D printing |
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