Five-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement With RESILIA Tissue
The COMMENCE trial was conducted to evaluate the safety and effectiveness of aortic valve replacement using a bioprosthesis with novel RESILIA tissue (Edwards Lifesciences). RESILIA tissue is incorporated in the INSPIRIS RESILIA aortic valve (Edwards Lifesciences). Patients underwent clinically indi...
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| Veröffentlicht in: | The Annals of thoracic surgery 2023-06, Vol.115 (6), p.1429-1436 |
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| creator | Bavaria, Joseph E. Griffith, Bartley Heimansohn, David A. Rozanski, Jacek Johnston, Douglas R. Bartus, Krzysztof Girardi, Leonard N. Beaver, Thomas Takayama, Hiroo Mumtaz, Mubashir A. Rosengart, Todd K. Starnes, Vaughn Timek, Tomasz A. Boateng, Percy Ryan, William Cornwell, Lorraine D. Blackstone, Eugene H. Borger, Michael A. Pibarot, Philippe Thourani, Vinod H. Svensson, Lars G. Puskas, John D. |
| description | The COMMENCE trial was conducted to evaluate the safety and effectiveness of aortic valve replacement using a bioprosthesis with novel RESILIA tissue (Edwards Lifesciences). RESILIA tissue is incorporated in the INSPIRIS RESILIA aortic valve (Edwards Lifesciences).
Patients underwent clinically indicated surgical aortic valve replacement with a bovine pericardial bioprosthesis (model 11000A; Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), US Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee, and echocardiograms were analyzed by an independent core laboratory. Outcomes through an observational period of 5 years are reported.
Between January 2013 and March 2016, 689 patients received the study valve. Mean patient age was 66.9 ± 11.6 years; Society of Thoracic Surgeons Predicted Risk of Mortality was 2.0% ± 1.8%; and 23.8%, 49.9%, and 24.4% of patients were New York Heart Association functional class I, II, and III at baseline, respectively. Through December 11, 2020 the follow-up duration was 4.3 ± 1.4 years, and the completeness of follow-up over the observational period was 95.5%. Early ( |
| doi_str_mv | 10.1016/j.athoracsur.2021.12.058 |
| format | Article |
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Patients underwent clinically indicated surgical aortic valve replacement with a bovine pericardial bioprosthesis (model 11000A; Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), US Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee, and echocardiograms were analyzed by an independent core laboratory. Outcomes through an observational period of 5 years are reported.
Between January 2013 and March 2016, 689 patients received the study valve. Mean patient age was 66.9 ± 11.6 years; Society of Thoracic Surgeons Predicted Risk of Mortality was 2.0% ± 1.8%; and 23.8%, 49.9%, and 24.4% of patients were New York Heart Association functional class I, II, and III at baseline, respectively. Through December 11, 2020 the follow-up duration was 4.3 ± 1.4 years, and the completeness of follow-up over the observational period was 95.5%. Early (<30 days) all-cause mortality was 1.2%, stroke 1.6%, and major paravalvular leak 0.1%. Five-year actuarial freedom from all-cause mortality, structural valve deterioration, and all-cause reintervention were 89.2%, 100%, and 98.7%, respectively. At 5 years the effective orifice area was 1.6 ± 0.5 cm2, mean gradient was 11.5 ± 6.0 mm Hg, 97.8% of patients were class I/II, and 97.8% and 96.3% of patients had none/trace paravalvular and transvalvular regurgitation, respectively.
The safety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue through 5 years are encouraging, with clinically stable hemodynamics, minimal regurgitation, and no evidence of structural valve deterioration.</description><identifier>ISSN: 0003-4975</identifier><identifier>EISSN: 1552-6259</identifier><identifier>DOI: 10.1016/j.athoracsur.2021.12.058</identifier><identifier>PMID: 35065065</identifier><language>eng</language><publisher>Netherlands: Elsevier Inc</publisher><subject>Aged ; Animals ; Aortic Valve - diagnostic imaging ; Aortic Valve - surgery ; Aortic Valve Stenosis ; Cattle ; Heart Valve Prosthesis Implantation ; Humans ; Middle Aged ; Prospective Studies ; Treatment Outcome</subject><ispartof>The Annals of thoracic surgery, 2023-06, Vol.115 (6), p.1429-1436</ispartof><rights>2023 The Society of Thoracic Surgeons</rights><rights>Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c374t-574a5a0c550e64faf7205e3b0e9f1dab93b3dfd41ab08a6b5469347a5f80fab3</citedby><cites>FETCH-LOGICAL-c374t-574a5a0c550e64faf7205e3b0e9f1dab93b3dfd41ab08a6b5469347a5f80fab3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0003497522000637$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35065065$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bavaria, Joseph E.</creatorcontrib><creatorcontrib>Griffith, Bartley</creatorcontrib><creatorcontrib>Heimansohn, David A.</creatorcontrib><creatorcontrib>Rozanski, Jacek</creatorcontrib><creatorcontrib>Johnston, Douglas R.</creatorcontrib><creatorcontrib>Bartus, Krzysztof</creatorcontrib><creatorcontrib>Girardi, Leonard N.</creatorcontrib><creatorcontrib>Beaver, Thomas</creatorcontrib><creatorcontrib>Takayama, Hiroo</creatorcontrib><creatorcontrib>Mumtaz, Mubashir A.</creatorcontrib><creatorcontrib>Rosengart, Todd K.</creatorcontrib><creatorcontrib>Starnes, Vaughn</creatorcontrib><creatorcontrib>Timek, Tomasz A.</creatorcontrib><creatorcontrib>Boateng, Percy</creatorcontrib><creatorcontrib>Ryan, William</creatorcontrib><creatorcontrib>Cornwell, Lorraine D.</creatorcontrib><creatorcontrib>Blackstone, Eugene H.</creatorcontrib><creatorcontrib>Borger, Michael A.</creatorcontrib><creatorcontrib>Pibarot, Philippe</creatorcontrib><creatorcontrib>Thourani, Vinod H.</creatorcontrib><creatorcontrib>Svensson, Lars G.</creatorcontrib><creatorcontrib>Puskas, John D.</creatorcontrib><creatorcontrib>COMMENCE Trial Investigators</creatorcontrib><title>Five-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement With RESILIA Tissue</title><title>The Annals of thoracic surgery</title><addtitle>Ann Thorac Surg</addtitle><description>The COMMENCE trial was conducted to evaluate the safety and effectiveness of aortic valve replacement using a bioprosthesis with novel RESILIA tissue (Edwards Lifesciences). RESILIA tissue is incorporated in the INSPIRIS RESILIA aortic valve (Edwards Lifesciences).
Patients underwent clinically indicated surgical aortic valve replacement with a bovine pericardial bioprosthesis (model 11000A; Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), US Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee, and echocardiograms were analyzed by an independent core laboratory. Outcomes through an observational period of 5 years are reported.
Between January 2013 and March 2016, 689 patients received the study valve. Mean patient age was 66.9 ± 11.6 years; Society of Thoracic Surgeons Predicted Risk of Mortality was 2.0% ± 1.8%; and 23.8%, 49.9%, and 24.4% of patients were New York Heart Association functional class I, II, and III at baseline, respectively. Through December 11, 2020 the follow-up duration was 4.3 ± 1.4 years, and the completeness of follow-up over the observational period was 95.5%. Early (<30 days) all-cause mortality was 1.2%, stroke 1.6%, and major paravalvular leak 0.1%. Five-year actuarial freedom from all-cause mortality, structural valve deterioration, and all-cause reintervention were 89.2%, 100%, and 98.7%, respectively. At 5 years the effective orifice area was 1.6 ± 0.5 cm2, mean gradient was 11.5 ± 6.0 mm Hg, 97.8% of patients were class I/II, and 97.8% and 96.3% of patients had none/trace paravalvular and transvalvular regurgitation, respectively.
The safety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue through 5 years are encouraging, with clinically stable hemodynamics, minimal regurgitation, and no evidence of structural valve deterioration.</description><subject>Aged</subject><subject>Animals</subject><subject>Aortic Valve - diagnostic imaging</subject><subject>Aortic Valve - surgery</subject><subject>Aortic Valve Stenosis</subject><subject>Cattle</subject><subject>Heart Valve Prosthesis Implantation</subject><subject>Humans</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Treatment Outcome</subject><issn>0003-4975</issn><issn>1552-6259</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkE1v2zAMhoVhRZN1_QuDjrvYk2TLH8csSLsAaQO0QXcUaJlKFPgjk2QD_fdzkLY7DiBAEHzJl3wIoZzFnPHsxzGGcOgdaD-4WDDBYy5iJotPZM6lFFEmZPmZzBljSZSWuZyRL94fp1JM7WsySyTLzjEn-s6OGL0iOLodgu5b9LQ3NByQLrcPD6vH5YrunIWGrrsRfbB7CLbb00XvgtX0BZoR6ROeGtDYYhfobxsO9Gn1vN6sF3RnvR_wK7ky0Hi8fcs3ZHe32i1_RZvt_Xq52EQ6ydMQyTwFCUxLyTBLDZhcMIlJxbA0vIaqTKqkNnXKoWIFZJVMszJJc5CmYAaq5IZ8v6w9uf7PMN2qWus1Ng102A9eiUwIkec8LyZpcZFq13vv0KiTsy24V8WZOhNWR_WPsDoTVlyoifA0-u3NZaharD8G35FOgp8XAU6vjhad8tpip7G2DnVQdW__7_IXPwSRsA</recordid><startdate>202306</startdate><enddate>202306</enddate><creator>Bavaria, Joseph E.</creator><creator>Griffith, Bartley</creator><creator>Heimansohn, David A.</creator><creator>Rozanski, Jacek</creator><creator>Johnston, Douglas R.</creator><creator>Bartus, Krzysztof</creator><creator>Girardi, Leonard N.</creator><creator>Beaver, Thomas</creator><creator>Takayama, Hiroo</creator><creator>Mumtaz, Mubashir A.</creator><creator>Rosengart, Todd K.</creator><creator>Starnes, Vaughn</creator><creator>Timek, Tomasz A.</creator><creator>Boateng, Percy</creator><creator>Ryan, William</creator><creator>Cornwell, Lorraine D.</creator><creator>Blackstone, Eugene H.</creator><creator>Borger, Michael A.</creator><creator>Pibarot, Philippe</creator><creator>Thourani, Vinod H.</creator><creator>Svensson, Lars G.</creator><creator>Puskas, John D.</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></search><sort><creationdate>202306</creationdate><title>Five-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement With RESILIA Tissue</title><author>Bavaria, Joseph E. ; 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RESILIA tissue is incorporated in the INSPIRIS RESILIA aortic valve (Edwards Lifesciences).
Patients underwent clinically indicated surgical aortic valve replacement with a bovine pericardial bioprosthesis (model 11000A; Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), US Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee, and echocardiograms were analyzed by an independent core laboratory. Outcomes through an observational period of 5 years are reported.
Between January 2013 and March 2016, 689 patients received the study valve. Mean patient age was 66.9 ± 11.6 years; Society of Thoracic Surgeons Predicted Risk of Mortality was 2.0% ± 1.8%; and 23.8%, 49.9%, and 24.4% of patients were New York Heart Association functional class I, II, and III at baseline, respectively. Through December 11, 2020 the follow-up duration was 4.3 ± 1.4 years, and the completeness of follow-up over the observational period was 95.5%. Early (<30 days) all-cause mortality was 1.2%, stroke 1.6%, and major paravalvular leak 0.1%. Five-year actuarial freedom from all-cause mortality, structural valve deterioration, and all-cause reintervention were 89.2%, 100%, and 98.7%, respectively. At 5 years the effective orifice area was 1.6 ± 0.5 cm2, mean gradient was 11.5 ± 6.0 mm Hg, 97.8% of patients were class I/II, and 97.8% and 96.3% of patients had none/trace paravalvular and transvalvular regurgitation, respectively.
The safety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue through 5 years are encouraging, with clinically stable hemodynamics, minimal regurgitation, and no evidence of structural valve deterioration.</abstract><cop>Netherlands</cop><pub>Elsevier Inc</pub><pmid>35065065</pmid><doi>10.1016/j.athoracsur.2021.12.058</doi><tpages>8</tpages></addata></record> |
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| source | MEDLINE; Elsevier ScienceDirect Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Aged Animals Aortic Valve - diagnostic imaging Aortic Valve - surgery Aortic Valve Stenosis Cattle Heart Valve Prosthesis Implantation Humans Middle Aged Prospective Studies Treatment Outcome |
| title | Five-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement With RESILIA Tissue |
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