Late Positive Remodeling and Late Lumen Gain Contribute to Vascular Restoration by a Non-Drug Eluting Bioresorbable Scaffold: A Four-Year Intravascular Ultrasound Study in Normal Porcine Coronary Arteries
BACKGROUND—The interplay between mechanical dilatation, resorption, and arterial response following implantation of bioresorbable scaffolds is still poorly understood. METHODS AND RESULTS—Long-term geometric changes in porcine coronary arteries in relation to gradual degradation of bioresorbable sca...
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| Veröffentlicht in: | Circulation. Cardiovascular interventions 2012-02, Vol.5 (1), p.39-46 |
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| creator | Strandberg, Erika Zeltinger, Joan Schulz, Daryl G Kaluza, Greg L |
| description | BACKGROUND—The interplay between mechanical dilatation, resorption, and arterial response following implantation of bioresorbable scaffolds is still poorly understood.
METHODS AND RESULTS—Long-term geometric changes in porcine coronary arteries in relation to gradual degradation of bioresorbable scaffolds were assessed in comparison with bare metal stents (BMS). Intravascular ultrasound (IVUS)-derived lumen, outer stent/scaffold, and reference vessel areas were evaluated in 94 polymer scaffolds and 46 BMS at 5 days and 3, 6, 12, 18, 24, and 55 months, in addition to polymer scaffold radial crush strength and molecular weight (MW) at 3, 6, and 12 months. BMS outer stent area and lumen area remained constant through 55 months (P=0.05, but within 1 standard deviation of 100%, and P=0.58, respectively), while significant increases were exhibited by polymer-scaffolded vessels with the maximum late lumen gain at 24 months, paralleled by the outer scaffold area increase, and then remaining at that increased level at 55 months (P |
| doi_str_mv | 10.1161/CIRCINTERVENTIONS.111.964270 |
| format | Article |
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METHODS AND RESULTS—Long-term geometric changes in porcine coronary arteries in relation to gradual degradation of bioresorbable scaffolds were assessed in comparison with bare metal stents (BMS). Intravascular ultrasound (IVUS)-derived lumen, outer stent/scaffold, and reference vessel areas were evaluated in 94 polymer scaffolds and 46 BMS at 5 days and 3, 6, 12, 18, 24, and 55 months, in addition to polymer scaffold radial crush strength and molecular weight (MW) at 3, 6, and 12 months. BMS outer stent area and lumen area remained constant through 55 months (P=0.05, but within 1 standard deviation of 100%, and P=0.58, respectively), while significant increases were exhibited by polymer-scaffolded vessels with the maximum late lumen gain at 24 months, paralleled by the outer scaffold area increase, and then remaining at that increased level at 55 months (P<0.01). By 12 months polymer scaffolds experienced significant reductions in radial strength and MW, while the animals underwent the largest weight gain. At 3 months and beyond, the patency ratio (lumen area/reference vessel area) of BMS remained constant (0.71 to 0.85, P=0.49). In contrast, that of polymer scaffolds increased and approached 1 (P=0.13).
CONCLUSIONS—Bioresorbable polymer scaffolds allow restoration of the treated segmentʼs ability to remodel outward to achieve level lumen transition between reference vessel and scaffold-treated regions, a process mediated by animal growth and scaffold degradation. This also introduces a challenge to standard analyses of IVUS outcomes relying on constant stent diameters over time.</description><identifier>ISSN: 1941-7640</identifier><identifier>EISSN: 1941-7632</identifier><identifier>DOI: 10.1161/CIRCINTERVENTIONS.111.964270</identifier><identifier>PMID: 22253358</identifier><language>eng</language><publisher>Hagerstown, MD: American Heart Association, Inc</publisher><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy ; Animals ; Biocompatible Materials - chemistry ; Biological and medical sciences ; Biomechanical Phenomena ; Blood Vessel Prosthesis Implantation ; Cardiovascular system ; Coronary Vessels - diagnostic imaging ; Coronary Vessels - pathology ; Coronary Vessels - surgery ; Emergency and intensive care: renal failure. Dialysis management ; Graft Occlusion, Vascular - diagnosis ; Graft Occlusion, Vascular - etiology ; Graft Occlusion, Vascular - pathology ; Humans ; Intensive care medicine ; Investigative techniques, diagnostic techniques (general aspects) ; Medical sciences ; Metals - chemistry ; Models, Animal ; Regeneration ; Stents ; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases ; Swine ; Ultrasonic investigative techniques ; Ultrasonography, Interventional ; Vascular Patency ; Vascular surgery: aorta, extremities, vena cava. Surgery of the lymphatic vessels</subject><ispartof>Circulation. Cardiovascular interventions, 2012-02, Vol.5 (1), p.39-46</ispartof><rights>2012 American Heart Association, Inc.</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3388-7e3b90dbd84c6e2d80eec3dffb00a13f2f07bb78e27629c3dca2717cd47cf0153</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3674,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25539841$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22253358$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Strandberg, Erika</creatorcontrib><creatorcontrib>Zeltinger, Joan</creatorcontrib><creatorcontrib>Schulz, Daryl G</creatorcontrib><creatorcontrib>Kaluza, Greg L</creatorcontrib><title>Late Positive Remodeling and Late Lumen Gain Contribute to Vascular Restoration by a Non-Drug Eluting Bioresorbable Scaffold: A Four-Year Intravascular Ultrasound Study in Normal Porcine Coronary Arteries</title><title>Circulation. Cardiovascular interventions</title><addtitle>Circ Cardiovasc Interv</addtitle><description>BACKGROUND—The interplay between mechanical dilatation, resorption, and arterial response following implantation of bioresorbable scaffolds is still poorly understood.
METHODS AND RESULTS—Long-term geometric changes in porcine coronary arteries in relation to gradual degradation of bioresorbable scaffolds were assessed in comparison with bare metal stents (BMS). Intravascular ultrasound (IVUS)-derived lumen, outer stent/scaffold, and reference vessel areas were evaluated in 94 polymer scaffolds and 46 BMS at 5 days and 3, 6, 12, 18, 24, and 55 months, in addition to polymer scaffold radial crush strength and molecular weight (MW) at 3, 6, and 12 months. BMS outer stent area and lumen area remained constant through 55 months (P=0.05, but within 1 standard deviation of 100%, and P=0.58, respectively), while significant increases were exhibited by polymer-scaffolded vessels with the maximum late lumen gain at 24 months, paralleled by the outer scaffold area increase, and then remaining at that increased level at 55 months (P<0.01). By 12 months polymer scaffolds experienced significant reductions in radial strength and MW, while the animals underwent the largest weight gain. At 3 months and beyond, the patency ratio (lumen area/reference vessel area) of BMS remained constant (0.71 to 0.85, P=0.49). In contrast, that of polymer scaffolds increased and approached 1 (P=0.13).
CONCLUSIONS—Bioresorbable polymer scaffolds allow restoration of the treated segmentʼs ability to remodel outward to achieve level lumen transition between reference vessel and scaffold-treated regions, a process mediated by animal growth and scaffold degradation. This also introduces a challenge to standard analyses of IVUS outcomes relying on constant stent diameters over time.</description><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>Animals</subject><subject>Biocompatible Materials - chemistry</subject><subject>Biological and medical sciences</subject><subject>Biomechanical Phenomena</subject><subject>Blood Vessel Prosthesis Implantation</subject><subject>Cardiovascular system</subject><subject>Coronary Vessels - diagnostic imaging</subject><subject>Coronary Vessels - pathology</subject><subject>Coronary Vessels - surgery</subject><subject>Emergency and intensive care: renal failure. Dialysis management</subject><subject>Graft Occlusion, Vascular - diagnosis</subject><subject>Graft Occlusion, Vascular - etiology</subject><subject>Graft Occlusion, Vascular - pathology</subject><subject>Humans</subject><subject>Intensive care medicine</subject><subject>Investigative techniques, diagnostic techniques (general aspects)</subject><subject>Medical sciences</subject><subject>Metals - chemistry</subject><subject>Models, Animal</subject><subject>Regeneration</subject><subject>Stents</subject><subject>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</subject><subject>Swine</subject><subject>Ultrasonic investigative techniques</subject><subject>Ultrasonography, Interventional</subject><subject>Vascular Patency</subject><subject>Vascular surgery: aorta, extremities, vena cava. Surgery of the lymphatic vessels</subject><issn>1941-7640</issn><issn>1941-7632</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNplUctuEzEUHSEQLYFfQF6AWE3xY56ITRrSEilKUZJWYjXyeO60Bo9d7HGr_CMfxS1Jy4KFZfv43HOvz0mSd4yeMFawj7PFerZYbefrq_lqu7hYbRBmJ3WR8ZI-S45ZnbG0LAR__nTO6FHyKoQflCJc8JfJEec8FyKvjpPfSzkC-eaCHvUdkDUMrgOj7TWRtiN_H5dxAEvOpbZk5uzodRsRHR25kkFFIz1WhdF5OWpnSbsjkqycTb_4eE3mJo4PYqfaeQjOt7I1QDZK9r0z3ScyJWcu-vQ7oMoCteXdo-alwVtwEafYjLHbEWy_cn6QBqf1SlvAabyz0u_I1I_gNYTXyYtemgBvDvskuTybb2df0-XF-WI2XaZKiKpKSxBtTbu2qzJVAO8qCqBE1_ctpZKJnve0bNuyAl4WvMYXJXnJStVlpeopy8Uk-bDXvfXuV8TPN4MOCoyRFlwMTY3-srxCiyfJ5z1TeReCh7659XrAmRtGm4c4m__iRJg1-zix_O2hUWwH6J6KH_NDwvsDAX2TpvfSKh3-8fJc1FXGkJfteffOoFfhp4n34JsbkGa8aSgToszqPOWUccoppSkuWok_lzS_WA</recordid><startdate>201202</startdate><enddate>201202</enddate><creator>Strandberg, Erika</creator><creator>Zeltinger, Joan</creator><creator>Schulz, Daryl G</creator><creator>Kaluza, Greg L</creator><general>American Heart Association, Inc</general><general>Lippincott Williams & Wilkins</general><scope>IQODW</scope><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></search><sort><creationdate>201202</creationdate><title>Late Positive Remodeling and Late Lumen Gain Contribute to Vascular Restoration by a Non-Drug Eluting Bioresorbable Scaffold: A Four-Year Intravascular Ultrasound Study in Normal Porcine Coronary Arteries</title><author>Strandberg, Erika ; Zeltinger, Joan ; Schulz, Daryl G ; Kaluza, Greg L</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3388-7e3b90dbd84c6e2d80eec3dffb00a13f2f07bb78e27629c3dca2717cd47cf0153</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</topic><topic>Animals</topic><topic>Biocompatible Materials - chemistry</topic><topic>Biological and medical sciences</topic><topic>Biomechanical Phenomena</topic><topic>Blood Vessel Prosthesis Implantation</topic><topic>Cardiovascular system</topic><topic>Coronary Vessels - diagnostic imaging</topic><topic>Coronary Vessels - pathology</topic><topic>Coronary Vessels - surgery</topic><topic>Emergency and intensive care: renal failure. Dialysis management</topic><topic>Graft Occlusion, Vascular - diagnosis</topic><topic>Graft Occlusion, Vascular - etiology</topic><topic>Graft Occlusion, Vascular - pathology</topic><topic>Humans</topic><topic>Intensive care medicine</topic><topic>Investigative techniques, diagnostic techniques (general aspects)</topic><topic>Medical sciences</topic><topic>Metals - chemistry</topic><topic>Models, Animal</topic><topic>Regeneration</topic><topic>Stents</topic><topic>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</topic><topic>Swine</topic><topic>Ultrasonic investigative techniques</topic><topic>Ultrasonography, Interventional</topic><topic>Vascular Patency</topic><topic>Vascular surgery: aorta, extremities, vena cava. Surgery of the lymphatic vessels</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Strandberg, Erika</creatorcontrib><creatorcontrib>Zeltinger, Joan</creatorcontrib><creatorcontrib>Schulz, Daryl G</creatorcontrib><creatorcontrib>Kaluza, Greg L</creatorcontrib><collection>Pascal-Francis</collection><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>Circulation. Cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Strandberg, Erika</au><au>Zeltinger, Joan</au><au>Schulz, Daryl G</au><au>Kaluza, Greg L</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Late Positive Remodeling and Late Lumen Gain Contribute to Vascular Restoration by a Non-Drug Eluting Bioresorbable Scaffold: A Four-Year Intravascular Ultrasound Study in Normal Porcine Coronary Arteries</atitle><jtitle>Circulation. Cardiovascular interventions</jtitle><addtitle>Circ Cardiovasc Interv</addtitle><date>2012-02</date><risdate>2012</risdate><volume>5</volume><issue>1</issue><spage>39</spage><epage>46</epage><pages>39-46</pages><issn>1941-7640</issn><eissn>1941-7632</eissn><abstract>BACKGROUND—The interplay between mechanical dilatation, resorption, and arterial response following implantation of bioresorbable scaffolds is still poorly understood.
METHODS AND RESULTS—Long-term geometric changes in porcine coronary arteries in relation to gradual degradation of bioresorbable scaffolds were assessed in comparison with bare metal stents (BMS). Intravascular ultrasound (IVUS)-derived lumen, outer stent/scaffold, and reference vessel areas were evaluated in 94 polymer scaffolds and 46 BMS at 5 days and 3, 6, 12, 18, 24, and 55 months, in addition to polymer scaffold radial crush strength and molecular weight (MW) at 3, 6, and 12 months. BMS outer stent area and lumen area remained constant through 55 months (P=0.05, but within 1 standard deviation of 100%, and P=0.58, respectively), while significant increases were exhibited by polymer-scaffolded vessels with the maximum late lumen gain at 24 months, paralleled by the outer scaffold area increase, and then remaining at that increased level at 55 months (P<0.01). By 12 months polymer scaffolds experienced significant reductions in radial strength and MW, while the animals underwent the largest weight gain. At 3 months and beyond, the patency ratio (lumen area/reference vessel area) of BMS remained constant (0.71 to 0.85, P=0.49). In contrast, that of polymer scaffolds increased and approached 1 (P=0.13).
CONCLUSIONS—Bioresorbable polymer scaffolds allow restoration of the treated segmentʼs ability to remodel outward to achieve level lumen transition between reference vessel and scaffold-treated regions, a process mediated by animal growth and scaffold degradation. This also introduces a challenge to standard analyses of IVUS outcomes relying on constant stent diameters over time.</abstract><cop>Hagerstown, MD</cop><pub>American Heart Association, Inc</pub><pmid>22253358</pmid><doi>10.1161/CIRCINTERVENTIONS.111.964270</doi><tpages>8</tpages></addata></record> |
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| ispartof | Circulation. Cardiovascular interventions, 2012-02, Vol.5 (1), p.39-46 |
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| source | MEDLINE; American Heart Association Journals; EZB-FREE-00999 freely available EZB journals |
| subjects | Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy Animals Biocompatible Materials - chemistry Biological and medical sciences Biomechanical Phenomena Blood Vessel Prosthesis Implantation Cardiovascular system Coronary Vessels - diagnostic imaging Coronary Vessels - pathology Coronary Vessels - surgery Emergency and intensive care: renal failure. Dialysis management Graft Occlusion, Vascular - diagnosis Graft Occlusion, Vascular - etiology Graft Occlusion, Vascular - pathology Humans Intensive care medicine Investigative techniques, diagnostic techniques (general aspects) Medical sciences Metals - chemistry Models, Animal Regeneration Stents Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Swine Ultrasonic investigative techniques Ultrasonography, Interventional Vascular Patency Vascular surgery: aorta, extremities, vena cava. Surgery of the lymphatic vessels |
| title | Late Positive Remodeling and Late Lumen Gain Contribute to Vascular Restoration by a Non-Drug Eluting Bioresorbable Scaffold: A Four-Year Intravascular Ultrasound Study in Normal Porcine Coronary Arteries |
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