Treatment of calcific aortic stenosis with the percutaneous heart valve : Mid-term follow-up from the initial feasibility studies: the french experience
The aim of this work was to study the feasibility, safety, efficacy, and durability of percutaneous heart valve (PHV) implantation in the aortic position. We developed a PHV (equine pericardium valve in a balloon-expandable, stainless-steel stent) to treat patients with inoperable aortic stenosis (A...
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| Veröffentlicht in: | Journal of the American College of Cardiology 2006-03, Vol.47 (6), p.1214-1223 |
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| creator | CRIBIER, Alain EITCHANINOFF, Helene TRON, Christophe BAUER, Fabrice AGATIELLO, Carla NERCOLINI, Deborah TAPIERO, Sydney LITZLER, Pierre-Yves BESSOU, Jean-Paul BABALIAROS, Vasilis |
| description | The aim of this work was to study the feasibility, safety, efficacy, and durability of percutaneous heart valve (PHV) implantation in the aortic position.
We developed a PHV (equine pericardium valve in a balloon-expandable, stainless-steel stent) to treat patients with inoperable aortic stenosis (AS).
Thirty-six patients (aortic valve area < or =0.7 cm2, New York Heart Association [NYHA] functional class IV, and severe comorbidities), formally declined for surgery, were recruited on a compassionate basis. The PHV was implanted by retrograde or antegrade trans-septal approach. Clinical and echocardiographic outcomes were assessed serially.
Twenty-seven patients were implanted successfully (23 antegrade, 4 retrograde) in the subcoronary position with improvement in valve area (0.60 +/- 0.11 cm2 to 1.70 +/- 0.10 cm2, p < 0.0001) and transvalvular gradient (37 +/- 13 mm Hg to 9 +/- 2 mm Hg, p < 0.0001). Paravalvular aortic regurgitation was grade 0 to 1 (n = 10), grade 2 (n = 12), and grade 3 (n = 5). One week post-procedure, improvement in left ventricular function (45 +/- 18% to 53 +/- 14%, p = 0.02) was most pronounced in patients with ejection fraction 90% NYHA functional class I to II). Percutaneous heart valve function remained unchanged during follow-up, and no deaths were device-related.
Percutaneous heart valve implantation is feasible in inoperable patients with end-stage AS leading to hemodynamic and clinical improvement. Continued advances and improved patient selection should decrease adverse events in the near future. |
| doi_str_mv | 10.1016/j.jacc.2006.01.049 |
| format | Article |
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We developed a PHV (equine pericardium valve in a balloon-expandable, stainless-steel stent) to treat patients with inoperable aortic stenosis (AS).
Thirty-six patients (aortic valve area < or =0.7 cm2, New York Heart Association [NYHA] functional class IV, and severe comorbidities), formally declined for surgery, were recruited on a compassionate basis. The PHV was implanted by retrograde or antegrade trans-septal approach. Clinical and echocardiographic outcomes were assessed serially.
Twenty-seven patients were implanted successfully (23 antegrade, 4 retrograde) in the subcoronary position with improvement in valve area (0.60 +/- 0.11 cm2 to 1.70 +/- 0.10 cm2, p < 0.0001) and transvalvular gradient (37 +/- 13 mm Hg to 9 +/- 2 mm Hg, p < 0.0001). Paravalvular aortic regurgitation was grade 0 to 1 (n = 10), grade 2 (n = 12), and grade 3 (n = 5). One week post-procedure, improvement in left ventricular function (45 +/- 18% to 53 +/- 14%, p = 0.02) was most pronounced in patients with ejection fraction <50% (35 +/- 10% to 50 +/- 16%, p < 0.0001). Thirty-day major adverse events after successful implantation were 26% (pericardial tamponade, stroke, arrhythmia, urosepsis, and one death unexplained at autopsy). Eleven patients are currently alive with follow-up of 9 months (n = 2), 10 months (n = 3), 11 months (n = 1), 12 months (n = 2), 23 months (n = 1), and 26 months (n = 2). All patients experienced amelioration of symptoms (>90% NYHA functional class I to II). Percutaneous heart valve function remained unchanged during follow-up, and no deaths were device-related.
Percutaneous heart valve implantation is feasible in inoperable patients with end-stage AS leading to hemodynamic and clinical improvement. Continued advances and improved patient selection should decrease adverse events in the near future.</description><identifier>ISSN: 0735-1097</identifier><identifier>EISSN: 1558-3597</identifier><identifier>DOI: 10.1016/j.jacc.2006.01.049</identifier><identifier>PMID: 16545654</identifier><identifier>CODEN: JACCDI</identifier><language>eng</language><publisher>New York, NY: Elsevier Science</publisher><subject>Aged ; Aged, 80 and over ; Aortic Valve ; Aortic Valve Stenosis - complications ; Aortic Valve Stenosis - surgery ; Biological and medical sciences ; Calcinosis - complications ; Calcinosis - surgery ; Cardiology ; Cardiology. Vascular system ; Cardiovascular disease ; Colleges & universities ; Comorbidity ; Coronary vessels ; Endocardial and cardiac valvular diseases ; Feasibility Studies ; Female ; Follow-Up Studies ; Heart ; Heart attacks ; Heart surgery ; Heart Valve Diseases - complications ; Heart Valve Diseases - surgery ; Heart Valve Prosthesis ; Hospitals ; Humans ; Hypertension ; Male ; Medical sciences ; Middle Aged ; Mortality ; Pathology ; Patients ; Prostheses ; Stroke ; Time Factors</subject><ispartof>Journal of the American College of Cardiology, 2006-03, Vol.47 (6), p.1214-1223</ispartof><rights>2006 INIST-CNRS</rights><rights>Copyright Elsevier Limited Mar 21, 2006</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17678580$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16545654$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>CRIBIER, Alain</creatorcontrib><creatorcontrib>EITCHANINOFF, Helene</creatorcontrib><creatorcontrib>TRON, Christophe</creatorcontrib><creatorcontrib>BAUER, Fabrice</creatorcontrib><creatorcontrib>AGATIELLO, Carla</creatorcontrib><creatorcontrib>NERCOLINI, Deborah</creatorcontrib><creatorcontrib>TAPIERO, Sydney</creatorcontrib><creatorcontrib>LITZLER, Pierre-Yves</creatorcontrib><creatorcontrib>BESSOU, Jean-Paul</creatorcontrib><creatorcontrib>BABALIAROS, Vasilis</creatorcontrib><title>Treatment of calcific aortic stenosis with the percutaneous heart valve : Mid-term follow-up from the initial feasibility studies: the french experience</title><title>Journal of the American College of Cardiology</title><addtitle>J Am Coll Cardiol</addtitle><description>The aim of this work was to study the feasibility, safety, efficacy, and durability of percutaneous heart valve (PHV) implantation in the aortic position.
We developed a PHV (equine pericardium valve in a balloon-expandable, stainless-steel stent) to treat patients with inoperable aortic stenosis (AS).
Thirty-six patients (aortic valve area < or =0.7 cm2, New York Heart Association [NYHA] functional class IV, and severe comorbidities), formally declined for surgery, were recruited on a compassionate basis. The PHV was implanted by retrograde or antegrade trans-septal approach. Clinical and echocardiographic outcomes were assessed serially.
Twenty-seven patients were implanted successfully (23 antegrade, 4 retrograde) in the subcoronary position with improvement in valve area (0.60 +/- 0.11 cm2 to 1.70 +/- 0.10 cm2, p < 0.0001) and transvalvular gradient (37 +/- 13 mm Hg to 9 +/- 2 mm Hg, p < 0.0001). Paravalvular aortic regurgitation was grade 0 to 1 (n = 10), grade 2 (n = 12), and grade 3 (n = 5). One week post-procedure, improvement in left ventricular function (45 +/- 18% to 53 +/- 14%, p = 0.02) was most pronounced in patients with ejection fraction <50% (35 +/- 10% to 50 +/- 16%, p < 0.0001). Thirty-day major adverse events after successful implantation were 26% (pericardial tamponade, stroke, arrhythmia, urosepsis, and one death unexplained at autopsy). Eleven patients are currently alive with follow-up of 9 months (n = 2), 10 months (n = 3), 11 months (n = 1), 12 months (n = 2), 23 months (n = 1), and 26 months (n = 2). All patients experienced amelioration of symptoms (>90% NYHA functional class I to II). Percutaneous heart valve function remained unchanged during follow-up, and no deaths were device-related.
Percutaneous heart valve implantation is feasible in inoperable patients with end-stage AS leading to hemodynamic and clinical improvement. Continued advances and improved patient selection should decrease adverse events in the near future.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Aortic Valve</subject><subject>Aortic Valve Stenosis - complications</subject><subject>Aortic Valve Stenosis - surgery</subject><subject>Biological and medical sciences</subject><subject>Calcinosis - complications</subject><subject>Calcinosis - surgery</subject><subject>Cardiology</subject><subject>Cardiology. Vascular system</subject><subject>Cardiovascular disease</subject><subject>Colleges & universities</subject><subject>Comorbidity</subject><subject>Coronary vessels</subject><subject>Endocardial and cardiac valvular diseases</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Heart</subject><subject>Heart attacks</subject><subject>Heart surgery</subject><subject>Heart Valve Diseases - complications</subject><subject>Heart Valve Diseases - surgery</subject><subject>Heart Valve Prosthesis</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Pathology</subject><subject>Patients</subject><subject>Prostheses</subject><subject>Stroke</subject><subject>Time Factors</subject><issn>0735-1097</issn><issn>1558-3597</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpd0M1u1DAQAGALgehSeAEOyBKCW1I7ie2kN1TxJxX1Us7R2BkrXjnxYjstfRMet6ZdhNTDaObwzYw9hLzlrOaMy7N9vQdj6oYxWTNes254RnZciL5qxaCekx1Trag4G9QJeZXSnhXY8-ElOeFSdKLEjvy5jgh5wTXTYKkBb5x1hkKIuaSUcQ3JJXrr8kzzjPSA0WwZVgxbojNCzPQG_A3Sc_rDTVXGuFAbvA-31XagNobloc2tLjvw1CIkp513-a4M3yaH6fwB2IirmSn-LgtcKfE1eWHBJ3xzzKfk55fP1xffqsurr98vPl1Wc8uaXGlt-WS7Cbm2knU908ANDkp2rW409IbbRvaWDSBaLgwaw6zVErQQupOSt6fk4-PcQwy_Nkx5XFwy6P3jH0eplBiE-gvfP4H7sMW1vG3kgkkulZRNUe-OatMLTuMhugXi3fjv4gV8OAJI5dw2wmpc-u-UVL3oWXsPRh2UOw</recordid><startdate>20060321</startdate><enddate>20060321</enddate><creator>CRIBIER, Alain</creator><creator>EITCHANINOFF, Helene</creator><creator>TRON, Christophe</creator><creator>BAUER, Fabrice</creator><creator>AGATIELLO, Carla</creator><creator>NERCOLINI, Deborah</creator><creator>TAPIERO, Sydney</creator><creator>LITZLER, Pierre-Yves</creator><creator>BESSOU, Jean-Paul</creator><creator>BABALIAROS, Vasilis</creator><general>Elsevier Science</general><general>Elsevier Limited</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>20060321</creationdate><title>Treatment of calcific aortic stenosis with the percutaneous heart valve : Mid-term follow-up from the initial feasibility studies: the french experience</title><author>CRIBIER, Alain ; EITCHANINOFF, Helene ; TRON, Christophe ; BAUER, Fabrice ; AGATIELLO, Carla ; NERCOLINI, Deborah ; TAPIERO, Sydney ; LITZLER, Pierre-Yves ; BESSOU, Jean-Paul ; BABALIAROS, Vasilis</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-h302t-bbf1df4de1bf60480ba1ce97643b2ba8c1f268f09a5315cecc0ffb6ab55b46613</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Aortic Valve</topic><topic>Aortic Valve Stenosis - complications</topic><topic>Aortic Valve Stenosis - surgery</topic><topic>Biological and medical sciences</topic><topic>Calcinosis - complications</topic><topic>Calcinosis - surgery</topic><topic>Cardiology</topic><topic>Cardiology. Vascular system</topic><topic>Cardiovascular disease</topic><topic>Colleges & universities</topic><topic>Comorbidity</topic><topic>Coronary vessels</topic><topic>Endocardial and cardiac valvular diseases</topic><topic>Feasibility Studies</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Heart</topic><topic>Heart attacks</topic><topic>Heart surgery</topic><topic>Heart Valve Diseases - complications</topic><topic>Heart Valve Diseases - surgery</topic><topic>Heart Valve Prosthesis</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>Pathology</topic><topic>Patients</topic><topic>Prostheses</topic><topic>Stroke</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>CRIBIER, Alain</creatorcontrib><creatorcontrib>EITCHANINOFF, Helene</creatorcontrib><creatorcontrib>TRON, Christophe</creatorcontrib><creatorcontrib>BAUER, Fabrice</creatorcontrib><creatorcontrib>AGATIELLO, Carla</creatorcontrib><creatorcontrib>NERCOLINI, Deborah</creatorcontrib><creatorcontrib>TAPIERO, Sydney</creatorcontrib><creatorcontrib>LITZLER, Pierre-Yves</creatorcontrib><creatorcontrib>BESSOU, Jean-Paul</creatorcontrib><creatorcontrib>BABALIAROS, Vasilis</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>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of the American College of Cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>CRIBIER, Alain</au><au>EITCHANINOFF, Helene</au><au>TRON, Christophe</au><au>BAUER, Fabrice</au><au>AGATIELLO, Carla</au><au>NERCOLINI, Deborah</au><au>TAPIERO, Sydney</au><au>LITZLER, Pierre-Yves</au><au>BESSOU, Jean-Paul</au><au>BABALIAROS, Vasilis</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Treatment of calcific aortic stenosis with the percutaneous heart valve : Mid-term follow-up from the initial feasibility studies: the french experience</atitle><jtitle>Journal of the American College of Cardiology</jtitle><addtitle>J Am Coll Cardiol</addtitle><date>2006-03-21</date><risdate>2006</risdate><volume>47</volume><issue>6</issue><spage>1214</spage><epage>1223</epage><pages>1214-1223</pages><issn>0735-1097</issn><eissn>1558-3597</eissn><coden>JACCDI</coden><abstract>The aim of this work was to study the feasibility, safety, efficacy, and durability of percutaneous heart valve (PHV) implantation in the aortic position.
We developed a PHV (equine pericardium valve in a balloon-expandable, stainless-steel stent) to treat patients with inoperable aortic stenosis (AS).
Thirty-six patients (aortic valve area < or =0.7 cm2, New York Heart Association [NYHA] functional class IV, and severe comorbidities), formally declined for surgery, were recruited on a compassionate basis. The PHV was implanted by retrograde or antegrade trans-septal approach. Clinical and echocardiographic outcomes were assessed serially.
Twenty-seven patients were implanted successfully (23 antegrade, 4 retrograde) in the subcoronary position with improvement in valve area (0.60 +/- 0.11 cm2 to 1.70 +/- 0.10 cm2, p < 0.0001) and transvalvular gradient (37 +/- 13 mm Hg to 9 +/- 2 mm Hg, p < 0.0001). Paravalvular aortic regurgitation was grade 0 to 1 (n = 10), grade 2 (n = 12), and grade 3 (n = 5). One week post-procedure, improvement in left ventricular function (45 +/- 18% to 53 +/- 14%, p = 0.02) was most pronounced in patients with ejection fraction <50% (35 +/- 10% to 50 +/- 16%, p < 0.0001). Thirty-day major adverse events after successful implantation were 26% (pericardial tamponade, stroke, arrhythmia, urosepsis, and one death unexplained at autopsy). Eleven patients are currently alive with follow-up of 9 months (n = 2), 10 months (n = 3), 11 months (n = 1), 12 months (n = 2), 23 months (n = 1), and 26 months (n = 2). All patients experienced amelioration of symptoms (>90% NYHA functional class I to II). Percutaneous heart valve function remained unchanged during follow-up, and no deaths were device-related.
Percutaneous heart valve implantation is feasible in inoperable patients with end-stage AS leading to hemodynamic and clinical improvement. Continued advances and improved patient selection should decrease adverse events in the near future.</abstract><cop>New York, NY</cop><pub>Elsevier Science</pub><pmid>16545654</pmid><doi>10.1016/j.jacc.2006.01.049</doi><tpages>10</tpages></addata></record> |
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| subjects | Aged Aged, 80 and over Aortic Valve Aortic Valve Stenosis - complications Aortic Valve Stenosis - surgery Biological and medical sciences Calcinosis - complications Calcinosis - surgery Cardiology Cardiology. Vascular system Cardiovascular disease Colleges & universities Comorbidity Coronary vessels Endocardial and cardiac valvular diseases Feasibility Studies Female Follow-Up Studies Heart Heart attacks Heart surgery Heart Valve Diseases - complications Heart Valve Diseases - surgery Heart Valve Prosthesis Hospitals Humans Hypertension Male Medical sciences Middle Aged Mortality Pathology Patients Prostheses Stroke Time Factors |
| title | Treatment of calcific aortic stenosis with the percutaneous heart valve : Mid-term follow-up from the initial feasibility studies: the french experience |
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