Prosthesis–patient mismatch in high-risk patients with severe aortic stenosis: A randomized trial of a self-expanding prosthesis
Abstract Objectives We compared the incidence of prosthesis–patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence...
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| Veröffentlicht in: | The Journal of thoracic and cardiovascular surgery 2016-04, Vol.151 (4), p.1014-1023.e3 |
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| creator | Zorn, George L., MD Little, Stephen H., MD Tadros, Peter, MD Deeb, G. Michael, MD Gleason, Thomas G., MD Heiser, John, MD Kleiman, Neal S., MD Oh, Jae K., MD Popma, Jeffrey J., MD Adams, David, MD Huang, Jian, MD Reardon, Michael J., MD |
| description | Abstract Objectives We compared the incidence of prosthesis–patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence of PPM on clinical outcomes. Methods Patients with severe aortic stenosis and at increased risk for surgery were randomized 1:1 to TAVR or SAVR. Postoperative PPM was defined by the effective orifice area index (EOAi) as severe PPM (EOAi ≤ 0.65 cm2 /m2 ) and no severe PPM (EOAi > 0.65 cm2 /m2 ); clinical outcomes were analyzed in the TAVR arm (n = 389) and SAVR arm (n = 353). Left ventricular mass index and regression were analyzed at baseline and 1 year. Results The incidence of severe PPM in the SAVR group at 1 year was 25.7% versus 6.2% in the TAVR group ( P |
| doi_str_mv | 10.1016/j.jtcvs.2015.10.070 |
| format | Article |
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Michael, MD ; Gleason, Thomas G., MD ; Heiser, John, MD ; Kleiman, Neal S., MD ; Oh, Jae K., MD ; Popma, Jeffrey J., MD ; Adams, David, MD ; Huang, Jian, MD ; Reardon, Michael J., MD</creator><creatorcontrib>Zorn, George L., MD ; Little, Stephen H., MD ; Tadros, Peter, MD ; Deeb, G. Michael, MD ; Gleason, Thomas G., MD ; Heiser, John, MD ; Kleiman, Neal S., MD ; Oh, Jae K., MD ; Popma, Jeffrey J., MD ; Adams, David, MD ; Huang, Jian, MD ; Reardon, Michael J., MD</creatorcontrib><description>Abstract Objectives We compared the incidence of prosthesis–patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence of PPM on clinical outcomes. Methods Patients with severe aortic stenosis and at increased risk for surgery were randomized 1:1 to TAVR or SAVR. Postoperative PPM was defined by the effective orifice area index (EOAi) as severe PPM (EOAi ≤ 0.65 cm2 /m2 ) and no severe PPM (EOAi > 0.65 cm2 /m2 ); clinical outcomes were analyzed in the TAVR arm (n = 389) and SAVR arm (n = 353). Left ventricular mass index and regression were analyzed at baseline and 1 year. Results The incidence of severe PPM in the SAVR group at 1 year was 25.7% versus 6.2% in the TAVR group ( P < .0001). Left ventricular mass index regression at 1 year was 6.8% for TAVR and 15.1% for SAVR in patients with severe PPM. At 1 year the rate of all-cause mortality and acute kidney injury were significantly greater in all patients (TAVR + SAVR) with severe PPM compared with no severe PPM (20.6% vs 12.0% [ P = .0145] for death and 19.2% vs 8.5% [ P = .0008] for acute kidney injury). Conclusions In patients with high surgical risk and severe aortic stenosis, severe PPM is more common in patients treated with SAVR than those treated with TAVR. Patients with severe PPM are a greater risk for death and acute kidney injury than patients without severe PPM.</description><identifier>ISSN: 0022-5223</identifier><identifier>EISSN: 1097-685X</identifier><identifier>DOI: 10.1016/j.jtcvs.2015.10.070</identifier><identifier>PMID: 26614412</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Acute Kidney Injury - epidemiology ; aortic stenosis ; Aortic Valve - diagnostic imaging ; Aortic Valve - physiopathology ; Aortic Valve - surgery ; Aortic Valve Stenosis - diagnosis ; Aortic Valve Stenosis - mortality ; Aortic Valve Stenosis - physiopathology ; Aortic Valve Stenosis - surgery ; Aortic Valve Stenosis - therapy ; Bioprosthesis ; Cardiac Catheterization - adverse effects ; Cardiac Catheterization - instrumentation ; Cardiac Catheterization - mortality ; Cardiothoracic Surgery ; Echocardiography, Doppler ; Heart Valve Prosthesis ; Heart Valve Prosthesis Implantation - adverse effects ; Heart Valve Prosthesis Implantation - instrumentation ; Heart Valve Prosthesis Implantation - mortality ; Humans ; Incidence ; Kaplan-Meier Estimate ; Postoperative Complications - diagnosis ; Postoperative Complications - epidemiology ; Postoperative Complications - mortality ; Proportional Hazards Models ; Prospective Studies ; Prosthesis Design ; prosthesis-patient mismatch ; Risk Assessment ; Risk Factors ; Severity of Illness Index ; Time Factors ; transcatheter aortic valve replacement ; Treatment Outcome ; United States - epidemiology ; Ventricular Function, Left ; Ventricular Remodeling</subject><ispartof>The Journal of thoracic and cardiovascular surgery, 2016-04, Vol.151 (4), p.1014-1023.e3</ispartof><rights>The American Association for Thoracic Surgery</rights><rights>2016 The American Association for Thoracic Surgery</rights><rights>Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c459t-c7fa03d60c796e473626ff16de414a534f70d493176385c511e20cc0e4fde2173</citedby><cites>FETCH-LOGICAL-c459t-c7fa03d60c796e473626ff16de414a534f70d493176385c511e20cc0e4fde2173</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0022522315021339$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26614412$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zorn, George L., MD</creatorcontrib><creatorcontrib>Little, Stephen H., MD</creatorcontrib><creatorcontrib>Tadros, Peter, MD</creatorcontrib><creatorcontrib>Deeb, G. Michael, MD</creatorcontrib><creatorcontrib>Gleason, Thomas G., MD</creatorcontrib><creatorcontrib>Heiser, John, MD</creatorcontrib><creatorcontrib>Kleiman, Neal S., MD</creatorcontrib><creatorcontrib>Oh, Jae K., MD</creatorcontrib><creatorcontrib>Popma, Jeffrey J., MD</creatorcontrib><creatorcontrib>Adams, David, MD</creatorcontrib><creatorcontrib>Huang, Jian, MD</creatorcontrib><creatorcontrib>Reardon, Michael J., MD</creatorcontrib><title>Prosthesis–patient mismatch in high-risk patients with severe aortic stenosis: A randomized trial of a self-expanding prosthesis</title><title>The Journal of thoracic and cardiovascular surgery</title><addtitle>J Thorac Cardiovasc Surg</addtitle><description>Abstract Objectives We compared the incidence of prosthesis–patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence of PPM on clinical outcomes. Methods Patients with severe aortic stenosis and at increased risk for surgery were randomized 1:1 to TAVR or SAVR. Postoperative PPM was defined by the effective orifice area index (EOAi) as severe PPM (EOAi ≤ 0.65 cm2 /m2 ) and no severe PPM (EOAi > 0.65 cm2 /m2 ); clinical outcomes were analyzed in the TAVR arm (n = 389) and SAVR arm (n = 353). Left ventricular mass index and regression were analyzed at baseline and 1 year. Results The incidence of severe PPM in the SAVR group at 1 year was 25.7% versus 6.2% in the TAVR group ( P < .0001). Left ventricular mass index regression at 1 year was 6.8% for TAVR and 15.1% for SAVR in patients with severe PPM. At 1 year the rate of all-cause mortality and acute kidney injury were significantly greater in all patients (TAVR + SAVR) with severe PPM compared with no severe PPM (20.6% vs 12.0% [ P = .0145] for death and 19.2% vs 8.5% [ P = .0008] for acute kidney injury). Conclusions In patients with high surgical risk and severe aortic stenosis, severe PPM is more common in patients treated with SAVR than those treated with TAVR. Patients with severe PPM are a greater risk for death and acute kidney injury than patients without severe PPM.</description><subject>Acute Kidney Injury - epidemiology</subject><subject>aortic stenosis</subject><subject>Aortic Valve - diagnostic imaging</subject><subject>Aortic Valve - physiopathology</subject><subject>Aortic Valve - surgery</subject><subject>Aortic Valve Stenosis - diagnosis</subject><subject>Aortic Valve Stenosis - mortality</subject><subject>Aortic Valve Stenosis - physiopathology</subject><subject>Aortic Valve Stenosis - surgery</subject><subject>Aortic Valve Stenosis - therapy</subject><subject>Bioprosthesis</subject><subject>Cardiac Catheterization - adverse effects</subject><subject>Cardiac Catheterization - instrumentation</subject><subject>Cardiac Catheterization - mortality</subject><subject>Cardiothoracic Surgery</subject><subject>Echocardiography, Doppler</subject><subject>Heart Valve Prosthesis</subject><subject>Heart Valve Prosthesis Implantation - adverse effects</subject><subject>Heart Valve Prosthesis Implantation - instrumentation</subject><subject>Heart Valve Prosthesis Implantation - mortality</subject><subject>Humans</subject><subject>Incidence</subject><subject>Kaplan-Meier Estimate</subject><subject>Postoperative Complications - diagnosis</subject><subject>Postoperative Complications - epidemiology</subject><subject>Postoperative Complications - mortality</subject><subject>Proportional Hazards Models</subject><subject>Prospective Studies</subject><subject>Prosthesis Design</subject><subject>prosthesis-patient mismatch</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Severity of Illness Index</subject><subject>Time Factors</subject><subject>transcatheter aortic valve replacement</subject><subject>Treatment Outcome</subject><subject>United States - epidemiology</subject><subject>Ventricular Function, Left</subject><subject>Ventricular Remodeling</subject><issn>0022-5223</issn><issn>1097-685X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkcuKFTEQhoMoznH0CQTJ0k0fU7lOCwrD4A0GFFRwF2K6ejo9fTkmOWccV-Ir-IY-iWnPcRZuXAWq_r_-1FeEPAS2Bgb6Sb_us9-lNWegSmXNDLtFVsBqU-kT9ek2WTHGeaU4F0fkXko9Y0UC9V1yxLUGKYGvyI93cU65wxTSr-8_Ny4HnDIdQxpd9h0NE-3CRVfFkC7poZvoVcgdTbjDiNTNMQdPU8ZpLkOe0lMa3dTMY_iGDc0xuIHOLXVFP7QVft2UZpgu6OYm9z6507oh4YPDe0w-vnzx4ex1df721Zuz0_PKS1XnypvWMdFo5k2tURqhuW5b0A1KkE4J2RrWyFqA0eJEeQWAnHnPULYNcjDimDzezy3RX7aYsi1rehwGN-G8TRaMUaAVk7xIxV7qyy9TxNZuYhhdvLbA7ALf9vYPfLvAX4qFbHE9OgRsP4_Y3Hj-0i6CZ3sBljV3AaNNvhD12ISIPttmDv8JeP6P3w9hCt4Nl3iNqZ-3cSoELdjELbPvl_sv5wfFOAhRi99kZa6w</recordid><startdate>20160401</startdate><enddate>20160401</enddate><creator>Zorn, George L., MD</creator><creator>Little, Stephen H., MD</creator><creator>Tadros, Peter, MD</creator><creator>Deeb, G. Michael, MD</creator><creator>Gleason, Thomas G., MD</creator><creator>Heiser, John, MD</creator><creator>Kleiman, Neal S., MD</creator><creator>Oh, Jae K., MD</creator><creator>Popma, Jeffrey J., MD</creator><creator>Adams, David, MD</creator><creator>Huang, Jian, MD</creator><creator>Reardon, Michael J., MD</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</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>20160401</creationdate><title>Prosthesis–patient mismatch in high-risk patients with severe aortic stenosis: A randomized trial of a self-expanding prosthesis</title><author>Zorn, George L., MD ; Little, Stephen H., MD ; Tadros, Peter, MD ; Deeb, G. Michael, MD ; Gleason, Thomas G., MD ; Heiser, John, MD ; Kleiman, Neal S., MD ; Oh, Jae K., MD ; Popma, Jeffrey J., MD ; Adams, David, MD ; Huang, Jian, MD ; Reardon, Michael J., MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c459t-c7fa03d60c796e473626ff16de414a534f70d493176385c511e20cc0e4fde2173</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Acute Kidney Injury - epidemiology</topic><topic>aortic stenosis</topic><topic>Aortic Valve - diagnostic imaging</topic><topic>Aortic Valve - physiopathology</topic><topic>Aortic Valve - surgery</topic><topic>Aortic Valve Stenosis - diagnosis</topic><topic>Aortic Valve Stenosis - mortality</topic><topic>Aortic Valve Stenosis - physiopathology</topic><topic>Aortic Valve Stenosis - surgery</topic><topic>Aortic Valve Stenosis - therapy</topic><topic>Bioprosthesis</topic><topic>Cardiac Catheterization - adverse effects</topic><topic>Cardiac Catheterization - instrumentation</topic><topic>Cardiac Catheterization - mortality</topic><topic>Cardiothoracic Surgery</topic><topic>Echocardiography, Doppler</topic><topic>Heart Valve Prosthesis</topic><topic>Heart Valve Prosthesis Implantation - adverse effects</topic><topic>Heart Valve Prosthesis Implantation - instrumentation</topic><topic>Heart Valve Prosthesis Implantation - mortality</topic><topic>Humans</topic><topic>Incidence</topic><topic>Kaplan-Meier Estimate</topic><topic>Postoperative Complications - diagnosis</topic><topic>Postoperative Complications - epidemiology</topic><topic>Postoperative Complications - mortality</topic><topic>Proportional Hazards Models</topic><topic>Prospective Studies</topic><topic>Prosthesis Design</topic><topic>prosthesis-patient mismatch</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Severity of Illness Index</topic><topic>Time Factors</topic><topic>transcatheter aortic valve replacement</topic><topic>Treatment Outcome</topic><topic>United States - epidemiology</topic><topic>Ventricular Function, Left</topic><topic>Ventricular Remodeling</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zorn, George L., MD</creatorcontrib><creatorcontrib>Little, Stephen H., MD</creatorcontrib><creatorcontrib>Tadros, Peter, MD</creatorcontrib><creatorcontrib>Deeb, G. Michael, MD</creatorcontrib><creatorcontrib>Gleason, Thomas G., MD</creatorcontrib><creatorcontrib>Heiser, John, MD</creatorcontrib><creatorcontrib>Kleiman, Neal S., MD</creatorcontrib><creatorcontrib>Oh, Jae K., MD</creatorcontrib><creatorcontrib>Popma, Jeffrey J., MD</creatorcontrib><creatorcontrib>Adams, David, MD</creatorcontrib><creatorcontrib>Huang, Jian, MD</creatorcontrib><creatorcontrib>Reardon, Michael J., MD</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</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>The Journal of thoracic and cardiovascular surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zorn, George L., MD</au><au>Little, Stephen H., MD</au><au>Tadros, Peter, MD</au><au>Deeb, G. Michael, MD</au><au>Gleason, Thomas G., MD</au><au>Heiser, John, MD</au><au>Kleiman, Neal S., MD</au><au>Oh, Jae K., MD</au><au>Popma, Jeffrey J., MD</au><au>Adams, David, MD</au><au>Huang, Jian, MD</au><au>Reardon, Michael J., MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prosthesis–patient mismatch in high-risk patients with severe aortic stenosis: A randomized trial of a self-expanding prosthesis</atitle><jtitle>The Journal of thoracic and cardiovascular surgery</jtitle><addtitle>J Thorac Cardiovasc Surg</addtitle><date>2016-04-01</date><risdate>2016</risdate><volume>151</volume><issue>4</issue><spage>1014</spage><epage>1023.e3</epage><pages>1014-1023.e3</pages><issn>0022-5223</issn><eissn>1097-685X</eissn><abstract>Abstract Objectives We compared the incidence of prosthesis–patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence of PPM on clinical outcomes. Methods Patients with severe aortic stenosis and at increased risk for surgery were randomized 1:1 to TAVR or SAVR. Postoperative PPM was defined by the effective orifice area index (EOAi) as severe PPM (EOAi ≤ 0.65 cm2 /m2 ) and no severe PPM (EOAi > 0.65 cm2 /m2 ); clinical outcomes were analyzed in the TAVR arm (n = 389) and SAVR arm (n = 353). Left ventricular mass index and regression were analyzed at baseline and 1 year. Results The incidence of severe PPM in the SAVR group at 1 year was 25.7% versus 6.2% in the TAVR group ( P < .0001). Left ventricular mass index regression at 1 year was 6.8% for TAVR and 15.1% for SAVR in patients with severe PPM. At 1 year the rate of all-cause mortality and acute kidney injury were significantly greater in all patients (TAVR + SAVR) with severe PPM compared with no severe PPM (20.6% vs 12.0% [ P = .0145] for death and 19.2% vs 8.5% [ P = .0008] for acute kidney injury). Conclusions In patients with high surgical risk and severe aortic stenosis, severe PPM is more common in patients treated with SAVR than those treated with TAVR. Patients with severe PPM are a greater risk for death and acute kidney injury than patients without severe PPM.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26614412</pmid><doi>10.1016/j.jtcvs.2015.10.070</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | The Journal of thoracic and cardiovascular surgery, 2016-04, Vol.151 (4), p.1014-1023.e3 |
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| subjects | Acute Kidney Injury - epidemiology aortic stenosis Aortic Valve - diagnostic imaging Aortic Valve - physiopathology Aortic Valve - surgery Aortic Valve Stenosis - diagnosis Aortic Valve Stenosis - mortality Aortic Valve Stenosis - physiopathology Aortic Valve Stenosis - surgery Aortic Valve Stenosis - therapy Bioprosthesis Cardiac Catheterization - adverse effects Cardiac Catheterization - instrumentation Cardiac Catheterization - mortality Cardiothoracic Surgery Echocardiography, Doppler Heart Valve Prosthesis Heart Valve Prosthesis Implantation - adverse effects Heart Valve Prosthesis Implantation - instrumentation Heart Valve Prosthesis Implantation - mortality Humans Incidence Kaplan-Meier Estimate Postoperative Complications - diagnosis Postoperative Complications - epidemiology Postoperative Complications - mortality Proportional Hazards Models Prospective Studies Prosthesis Design prosthesis-patient mismatch Risk Assessment Risk Factors Severity of Illness Index Time Factors transcatheter aortic valve replacement Treatment Outcome United States - epidemiology Ventricular Function, Left Ventricular Remodeling |
| title | Prosthesis–patient mismatch in high-risk patients with severe aortic stenosis: A randomized trial of a self-expanding prosthesis |
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