Comparative Outcomes of Balloon-Expandable S3 Versus Self-Expanding Evolut Bioprostheses for Transcatheter Aortic Valve Implantation
To date, comparisons between the balloon-expandable Edwards Sapien S3 (S3) versus the self-expanding Evolut R or PRO (Evolut) valves have been limited with respect to procedural outcomes. We aim to compare the safety, efficacy, and procedural efficiency of the S3 versus the Medtronic Evolut bioprost...
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| Veröffentlicht in: | The American journal of cardiology 2019-11, Vol.124 (10), p.1621-1629 |
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| creator | Mosleh, Wassim Amer, Mostafa R. Joshi, Saurabh Mather, Jeffrey F. Gandhi, Sumeet Iyer, Vijay Curtis, Lauren Kiernan, Francis J. McMahon, Sean Duvall, Lane McKay, Raymond G. |
| description | To date, comparisons between the balloon-expandable Edwards Sapien S3 (S3) versus the self-expanding Evolut R or PRO (Evolut) valves have been limited with respect to procedural outcomes. We aim to compare the safety, efficacy, and procedural efficiency of the S3 versus the Medtronic Evolut bioprostheses in patients who underwent transcatheter aortic valve implantation for severe aortic stenosis. Retrospective analysis was performed of all consecutive transcatheter aortic valve implantation procedures performed through the transfemoral approach with either S3 or Evolut at our hospital between September 2015 and January 2019. A total of 581 patients were included. There were no significant differences between S3 (n = 452) and Evolut (n = 129) concerning in-hospital or 30-day safety outcomes. S3 was associated with significantly shorter fluoroscopy times, lower fluoroscopy Air Kerma, and higher contrast use. S3 had lower postprocedure aortic valve area (1.71 ± 0.45 vs 1.84 ± 0.50 cm2, p = 0.004), larger peak gradient at 30 days (10.7 ± 3.8 vs 7.0 ± 3.2 mm Hg, p |
| doi_str_mv | 10.1016/j.amjcard.2019.08.014 |
| format | Article |
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We aim to compare the safety, efficacy, and procedural efficiency of the S3 versus the Medtronic Evolut bioprostheses in patients who underwent transcatheter aortic valve implantation for severe aortic stenosis. Retrospective analysis was performed of all consecutive transcatheter aortic valve implantation procedures performed through the transfemoral approach with either S3 or Evolut at our hospital between September 2015 and January 2019. A total of 581 patients were included. There were no significant differences between S3 (n = 452) and Evolut (n = 129) concerning in-hospital or 30-day safety outcomes. S3 was associated with significantly shorter fluoroscopy times, lower fluoroscopy Air Kerma, and higher contrast use. S3 had lower postprocedure aortic valve area (1.71 ± 0.45 vs 1.84 ± 0.50 cm2, p = 0.004), larger peak gradient at 30 days (10.7 ± 3.8 vs 7.0 ± 3.2 mm Hg, p <0.001), and lower aortic regurgitation (AR) rates postprocedure (47% vs 33%, p = 0.024) and at 30 days (50% vs 33%, p = 0.008), driven by mild AR. Device type was an independent predictor of AR postprocedure and at 30 days. Patients with ≥mild AR were more likely to have had Evolut valves (odds ratio = 2.94, p <0.001), especially in larger valves (>26 mm). Severe prosthesis-patient mismatch was higher in S3 (14.8% vs 7.9%, p <0.001). In conclusion, S3 is associated with less radiation exposure, higher contrast use, and lower incidence of AR at 30 days. Alternately, S3 has a higher transaortic gradient at 30 days, and higher levels of severe prosthesis-patient mismatch.</description><identifier>ISSN: 0002-9149</identifier><identifier>EISSN: 1879-1913</identifier><identifier>DOI: 10.1016/j.amjcard.2019.08.014</identifier><identifier>PMID: 31547995</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged, 80 and over ; Anesthesia ; Aortic stenosis ; Aortic valve ; Aortic Valve - diagnostic imaging ; Aortic Valve - surgery ; Aortic Valve Stenosis - diagnosis ; Aortic Valve Stenosis - surgery ; Balloon treatment ; Bioprosthesis ; Clinical outcomes ; Data dictionaries ; Demographics ; Echocardiography ; Female ; Fluoroscopy ; Follow-Up Studies ; Heart failure ; Heart Valve Prosthesis ; Heart valves ; Hospitals ; Humans ; Implantation ; Intubation ; Male ; Mercury ; Mortality ; Patients ; Prostheses ; Prosthesis Design ; Radiation ; Radiation effects ; Regurgitation ; Retrospective Studies ; Risk assessment ; Safety ; Stenosis ; Stroke ; Transcatheter Aortic Valve Replacement - methods ; Transplants & implants ; Treatment Outcome</subject><ispartof>The American journal of cardiology, 2019-11, Vol.124 (10), p.1621-1629</ispartof><rights>2019 Elsevier Inc.</rights><rights>Copyright © 2019 Elsevier Inc. All rights reserved.</rights><rights>2019. Elsevier Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c393t-360cf95802e66d298917eaa989234a24e964cc51e5a1763cde547dfc5230608e3</citedby><cites>FETCH-LOGICAL-c393t-360cf95802e66d298917eaa989234a24e964cc51e5a1763cde547dfc5230608e3</cites><orcidid>0000-0001-5944-6603 ; 0000-0002-8499-9207 ; 0000-0002-4286-0864</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2310271500?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,776,780,3536,27903,27904,45974,64362,64364,64366,72216</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31547995$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mosleh, Wassim</creatorcontrib><creatorcontrib>Amer, Mostafa R.</creatorcontrib><creatorcontrib>Joshi, Saurabh</creatorcontrib><creatorcontrib>Mather, Jeffrey F.</creatorcontrib><creatorcontrib>Gandhi, Sumeet</creatorcontrib><creatorcontrib>Iyer, Vijay</creatorcontrib><creatorcontrib>Curtis, Lauren</creatorcontrib><creatorcontrib>Kiernan, Francis J.</creatorcontrib><creatorcontrib>McMahon, Sean</creatorcontrib><creatorcontrib>Duvall, Lane</creatorcontrib><creatorcontrib>McKay, Raymond G.</creatorcontrib><title>Comparative Outcomes of Balloon-Expandable S3 Versus Self-Expanding Evolut Bioprostheses for Transcatheter Aortic Valve Implantation</title><title>The American journal of cardiology</title><addtitle>Am J Cardiol</addtitle><description>To date, comparisons between the balloon-expandable Edwards Sapien S3 (S3) versus the self-expanding Evolut R or PRO (Evolut) valves have been limited with respect to procedural outcomes. We aim to compare the safety, efficacy, and procedural efficiency of the S3 versus the Medtronic Evolut bioprostheses in patients who underwent transcatheter aortic valve implantation for severe aortic stenosis. Retrospective analysis was performed of all consecutive transcatheter aortic valve implantation procedures performed through the transfemoral approach with either S3 or Evolut at our hospital between September 2015 and January 2019. A total of 581 patients were included. There were no significant differences between S3 (n = 452) and Evolut (n = 129) concerning in-hospital or 30-day safety outcomes. S3 was associated with significantly shorter fluoroscopy times, lower fluoroscopy Air Kerma, and higher contrast use. S3 had lower postprocedure aortic valve area (1.71 ± 0.45 vs 1.84 ± 0.50 cm2, p = 0.004), larger peak gradient at 30 days (10.7 ± 3.8 vs 7.0 ± 3.2 mm Hg, p <0.001), and lower aortic regurgitation (AR) rates postprocedure (47% vs 33%, p = 0.024) and at 30 days (50% vs 33%, p = 0.008), driven by mild AR. Device type was an independent predictor of AR postprocedure and at 30 days. Patients with ≥mild AR were more likely to have had Evolut valves (odds ratio = 2.94, p <0.001), especially in larger valves (>26 mm). Severe prosthesis-patient mismatch was higher in S3 (14.8% vs 7.9%, p <0.001). In conclusion, S3 is associated with less radiation exposure, higher contrast use, and lower incidence of AR at 30 days. Alternately, S3 has a higher transaortic gradient at 30 days, and higher levels of severe prosthesis-patient mismatch.</description><subject>Aged, 80 and over</subject><subject>Anesthesia</subject><subject>Aortic stenosis</subject><subject>Aortic valve</subject><subject>Aortic Valve - diagnostic imaging</subject><subject>Aortic Valve - surgery</subject><subject>Aortic Valve Stenosis - diagnosis</subject><subject>Aortic Valve Stenosis - surgery</subject><subject>Balloon treatment</subject><subject>Bioprosthesis</subject><subject>Clinical outcomes</subject><subject>Data dictionaries</subject><subject>Demographics</subject><subject>Echocardiography</subject><subject>Female</subject><subject>Fluoroscopy</subject><subject>Follow-Up Studies</subject><subject>Heart failure</subject><subject>Heart Valve Prosthesis</subject><subject>Heart valves</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Implantation</subject><subject>Intubation</subject><subject>Male</subject><subject>Mercury</subject><subject>Mortality</subject><subject>Patients</subject><subject>Prostheses</subject><subject>Prosthesis Design</subject><subject>Radiation</subject><subject>Radiation effects</subject><subject>Regurgitation</subject><subject>Retrospective Studies</subject><subject>Risk assessment</subject><subject>Safety</subject><subject>Stenosis</subject><subject>Stroke</subject><subject>Transcatheter Aortic Valve Replacement - methods</subject><subject>Transplants & implants</subject><subject>Treatment Outcome</subject><issn>0002-9149</issn><issn>1879-1913</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkUFv1DAQhS1ERbeFnwCyxIVLUo-dOPEJtaulVKrUQ0uvlutMwFESB9tZwZ0fjqtdOHDhNLL9zbw3foS8BVYCA3kxlGYarAldyRmokrUlg-oF2UDbqAIUiJdkwxjjhYJKnZKzGId8BKjlK3IqoK4apeoN-bX102KCSW6P9G5N1k8Yqe_plRlH7-di92Mxc2eeRqT3gj5iiGuk9zj2xxc3f6W7vR_XRK-cX4KP6RvGPKP3gT4EM0dr8k3CQC99SM7SRzNmrZtpGc2csrCfX5OT3owR3xzrOfnyafew_Vzc3l3fbC9vCyuUSIWQzPaqbhlHKTuuWgUNGpMrF5XhFSpZWVsD1gYaKWyHecuutzUXTLIWxTn5cJibbX5fMSY9uWhxzEbQr1FzrqSUDVQyo-__QQe_hjm701wA4w3UjGWqPlA27x0D9noJbjLhpwamn2PSgz7GpJ9j0qzVOabc9-44fX2asPvb9SeXDHw8AJi_Y-8w6GgdzhY7F9Am3Xn3H4nfhram4w</recordid><startdate>20191115</startdate><enddate>20191115</enddate><creator>Mosleh, Wassim</creator><creator>Amer, Mostafa R.</creator><creator>Joshi, Saurabh</creator><creator>Mather, Jeffrey F.</creator><creator>Gandhi, Sumeet</creator><creator>Iyer, Vijay</creator><creator>Curtis, Lauren</creator><creator>Kiernan, Francis J.</creator><creator>McMahon, Sean</creator><creator>Duvall, Lane</creator><creator>McKay, Raymond G.</creator><general>Elsevier Inc</general><general>Elsevier Limited</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>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>M7Z</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-5944-6603</orcidid><orcidid>https://orcid.org/0000-0002-8499-9207</orcidid><orcidid>https://orcid.org/0000-0002-4286-0864</orcidid></search><sort><creationdate>20191115</creationdate><title>Comparative Outcomes of Balloon-Expandable S3 Versus Self-Expanding Evolut Bioprostheses for Transcatheter Aortic Valve Implantation</title><author>Mosleh, Wassim ; Amer, Mostafa R. ; Joshi, Saurabh ; Mather, Jeffrey F. ; Gandhi, Sumeet ; Iyer, Vijay ; Curtis, Lauren ; Kiernan, Francis J. ; McMahon, Sean ; Duvall, Lane ; McKay, Raymond G.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c393t-360cf95802e66d298917eaa989234a24e964cc51e5a1763cde547dfc5230608e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Aged, 80 and over</topic><topic>Anesthesia</topic><topic>Aortic stenosis</topic><topic>Aortic valve</topic><topic>Aortic Valve - diagnostic imaging</topic><topic>Aortic Valve - surgery</topic><topic>Aortic Valve Stenosis - diagnosis</topic><topic>Aortic Valve Stenosis - surgery</topic><topic>Balloon treatment</topic><topic>Bioprosthesis</topic><topic>Clinical outcomes</topic><topic>Data dictionaries</topic><topic>Demographics</topic><topic>Echocardiography</topic><topic>Female</topic><topic>Fluoroscopy</topic><topic>Follow-Up Studies</topic><topic>Heart failure</topic><topic>Heart Valve Prosthesis</topic><topic>Heart valves</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Implantation</topic><topic>Intubation</topic><topic>Male</topic><topic>Mercury</topic><topic>Mortality</topic><topic>Patients</topic><topic>Prostheses</topic><topic>Prosthesis Design</topic><topic>Radiation</topic><topic>Radiation effects</topic><topic>Regurgitation</topic><topic>Retrospective Studies</topic><topic>Risk assessment</topic><topic>Safety</topic><topic>Stenosis</topic><topic>Stroke</topic><topic>Transcatheter Aortic Valve Replacement - 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Academic</collection><jtitle>The American journal of cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mosleh, Wassim</au><au>Amer, Mostafa R.</au><au>Joshi, Saurabh</au><au>Mather, Jeffrey F.</au><au>Gandhi, Sumeet</au><au>Iyer, Vijay</au><au>Curtis, Lauren</au><au>Kiernan, Francis J.</au><au>McMahon, Sean</au><au>Duvall, Lane</au><au>McKay, Raymond G.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparative Outcomes of Balloon-Expandable S3 Versus Self-Expanding Evolut Bioprostheses for Transcatheter Aortic Valve Implantation</atitle><jtitle>The American journal of cardiology</jtitle><addtitle>Am J Cardiol</addtitle><date>2019-11-15</date><risdate>2019</risdate><volume>124</volume><issue>10</issue><spage>1621</spage><epage>1629</epage><pages>1621-1629</pages><issn>0002-9149</issn><eissn>1879-1913</eissn><abstract>To date, comparisons between the balloon-expandable Edwards Sapien S3 (S3) versus the self-expanding Evolut R or PRO (Evolut) valves have been limited with respect to procedural outcomes. We aim to compare the safety, efficacy, and procedural efficiency of the S3 versus the Medtronic Evolut bioprostheses in patients who underwent transcatheter aortic valve implantation for severe aortic stenosis. Retrospective analysis was performed of all consecutive transcatheter aortic valve implantation procedures performed through the transfemoral approach with either S3 or Evolut at our hospital between September 2015 and January 2019. A total of 581 patients were included. There were no significant differences between S3 (n = 452) and Evolut (n = 129) concerning in-hospital or 30-day safety outcomes. S3 was associated with significantly shorter fluoroscopy times, lower fluoroscopy Air Kerma, and higher contrast use. S3 had lower postprocedure aortic valve area (1.71 ± 0.45 vs 1.84 ± 0.50 cm2, p = 0.004), larger peak gradient at 30 days (10.7 ± 3.8 vs 7.0 ± 3.2 mm Hg, p <0.001), and lower aortic regurgitation (AR) rates postprocedure (47% vs 33%, p = 0.024) and at 30 days (50% vs 33%, p = 0.008), driven by mild AR. Device type was an independent predictor of AR postprocedure and at 30 days. Patients with ≥mild AR were more likely to have had Evolut valves (odds ratio = 2.94, p <0.001), especially in larger valves (>26 mm). Severe prosthesis-patient mismatch was higher in S3 (14.8% vs 7.9%, p <0.001). In conclusion, S3 is associated with less radiation exposure, higher contrast use, and lower incidence of AR at 30 days. Alternately, S3 has a higher transaortic gradient at 30 days, and higher levels of severe prosthesis-patient mismatch.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>31547995</pmid><doi>10.1016/j.amjcard.2019.08.014</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-5944-6603</orcidid><orcidid>https://orcid.org/0000-0002-8499-9207</orcidid><orcidid>https://orcid.org/0000-0002-4286-0864</orcidid></addata></record> |
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| subjects | Aged, 80 and over Anesthesia Aortic stenosis Aortic valve Aortic Valve - diagnostic imaging Aortic Valve - surgery Aortic Valve Stenosis - diagnosis Aortic Valve Stenosis - surgery Balloon treatment Bioprosthesis Clinical outcomes Data dictionaries Demographics Echocardiography Female Fluoroscopy Follow-Up Studies Heart failure Heart Valve Prosthesis Heart valves Hospitals Humans Implantation Intubation Male Mercury Mortality Patients Prostheses Prosthesis Design Radiation Radiation effects Regurgitation Retrospective Studies Risk assessment Safety Stenosis Stroke Transcatheter Aortic Valve Replacement - methods Transplants & implants Treatment Outcome |
| title | Comparative Outcomes of Balloon-Expandable S3 Versus Self-Expanding Evolut Bioprostheses for Transcatheter Aortic Valve Implantation |
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