Transcatheter Treatment of Native Aortic Valve Regurgitation
Background: Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR.Objectives: The aim of this study was to describe the compassionate-...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Garcia, Santiago [verfasserIn] Ye, Jian [verfasserIn] Webb, John [verfasserIn] Reardon, Michael [verfasserIn] Kleiman, Neal [verfasserIn] Goel, Sachin [verfasserIn] Hatab, Taha [verfasserIn] Fam, Neil [verfasserIn] Peterson, Mark [verfasserIn] Liauw, Samantha [verfasserIn] Frisoli, Tiberio M. [verfasserIn] Bashir, Hanad [verfasserIn] Paige, Debra [verfasserIn] Rock, Darlene [verfasserIn] Schmidt, Christian [verfasserIn] Jollis, James G. [verfasserIn] Kereiakes, Dean J. [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2023 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: JACC Cardiovascular interventions - American College of Cardiology ; ID: gnd/1017722-X, New York, NY : Elsevier, 2008, 16 |
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| Übergeordnetes Werk: |
volume:16 |
| DOI / URN: |
10.1016/j.jcin.2023.05.018 |
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ELV062334921 |
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| 245 | 1 | 0 | |a Transcatheter Treatment of Native Aortic Valve Regurgitation |
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| 520 | |a Background: Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR.Objectives: The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve).Methods: A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm).Results: A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without the need for surgical conversion or a second transcatheter heart valve) was 81% (22 of 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience, leading to changes in valve design. At 30 days, there was 1 death, 1 stroke, and 3 new pacemakers (13%), and 88% of patients were in NYHA functional class I or II. No patient had residual AR of moderate or greater degree at 30 days.Conclusions: The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk. | ||
| 650 | 4 | |a aortic regurgitation | |
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| 650 | 4 | |a transcatheter aortic valve replacement | |
| 700 | 1 | |a Ye, Jian |e verfasserin |4 aut | |
| 700 | 1 | |a Webb, John |e verfasserin |4 aut | |
| 700 | 1 | |a Reardon, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Kleiman, Neal |e verfasserin |4 aut | |
| 700 | 1 | |a Goel, Sachin |e verfasserin |0 (orcid)0000-0001-6041-3876 |4 aut | |
| 700 | 1 | |a Hatab, Taha |e verfasserin |4 aut | |
| 700 | 1 | |a Fam, Neil |e verfasserin |4 aut | |
| 700 | 1 | |a Peterson, Mark |e verfasserin |4 aut | |
| 700 | 1 | |a Liauw, Samantha |e verfasserin |4 aut | |
| 700 | 1 | |a Frisoli, Tiberio M. |e verfasserin |4 aut | |
| 700 | 1 | |a Bashir, Hanad |e verfasserin |4 aut | |
| 700 | 1 | |a Paige, Debra |e verfasserin |4 aut | |
| 700 | 1 | |a Rock, Darlene |e verfasserin |4 aut | |
| 700 | 1 | |a Schmidt, Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Jollis, James G. |e verfasserin |4 aut | |
| 700 | 1 | |a Kereiakes, Dean J. |e verfasserin |4 aut | |
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10.1016/j.jcin.2023.05.018 doi (DE-627)ELV062334921 (ELSEVIER)S1936-8798(23)00844-0 DE-627 ger DE-627 rda eng 610 VZ 44.85 bkl Garcia, Santiago verfasserin aut Transcatheter Treatment of Native Aortic Valve Regurgitation 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR.Objectives: The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve).Methods: A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm).Results: A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without the need for surgical conversion or a second transcatheter heart valve) was 81% (22 of 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience, leading to changes in valve design. At 30 days, there was 1 death, 1 stroke, and 3 new pacemakers (13%), and 88% of patients were in NYHA functional class I or II. No patient had residual AR of moderate or greater degree at 30 days.Conclusions: The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk. aortic regurgitation compassionate use transcatheter aortic valve replacement Ye, Jian verfasserin aut Webb, John verfasserin aut Reardon, Michael verfasserin aut Kleiman, Neal verfasserin aut Goel, Sachin verfasserin (orcid)0000-0001-6041-3876 aut Hatab, Taha verfasserin aut Fam, Neil verfasserin aut Peterson, Mark verfasserin aut Liauw, Samantha verfasserin aut Frisoli, Tiberio M. verfasserin aut Bashir, Hanad verfasserin aut Paige, Debra verfasserin aut Rock, Darlene verfasserin aut Schmidt, Christian verfasserin aut Jollis, James G. verfasserin aut Kereiakes, Dean J. verfasserin aut Enthalten in American College of Cardiology ; ID: gnd/1017722-X JACC Cardiovascular interventions New York, NY : Elsevier, 2008 16 Online-Ressource (DE-627)578539160 (DE-600)2452163-2 (DE-576)294403027 1876-7605 nnns volume:16 GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 44.85 Kardiologie Angiologie VZ AR 16 |
| spelling |
10.1016/j.jcin.2023.05.018 doi (DE-627)ELV062334921 (ELSEVIER)S1936-8798(23)00844-0 DE-627 ger DE-627 rda eng 610 VZ 44.85 bkl Garcia, Santiago verfasserin aut Transcatheter Treatment of Native Aortic Valve Regurgitation 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR.Objectives: The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve).Methods: A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm).Results: A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without the need for surgical conversion or a second transcatheter heart valve) was 81% (22 of 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience, leading to changes in valve design. At 30 days, there was 1 death, 1 stroke, and 3 new pacemakers (13%), and 88% of patients were in NYHA functional class I or II. No patient had residual AR of moderate or greater degree at 30 days.Conclusions: The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk. aortic regurgitation compassionate use transcatheter aortic valve replacement Ye, Jian verfasserin aut Webb, John verfasserin aut Reardon, Michael verfasserin aut Kleiman, Neal verfasserin aut Goel, Sachin verfasserin (orcid)0000-0001-6041-3876 aut Hatab, Taha verfasserin aut Fam, Neil verfasserin aut Peterson, Mark verfasserin aut Liauw, Samantha verfasserin aut Frisoli, Tiberio M. verfasserin aut Bashir, Hanad verfasserin aut Paige, Debra verfasserin aut Rock, Darlene verfasserin aut Schmidt, Christian verfasserin aut Jollis, James G. verfasserin aut Kereiakes, Dean J. verfasserin aut Enthalten in American College of Cardiology ; ID: gnd/1017722-X JACC Cardiovascular interventions New York, NY : Elsevier, 2008 16 Online-Ressource (DE-627)578539160 (DE-600)2452163-2 (DE-576)294403027 1876-7605 nnns volume:16 GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 44.85 Kardiologie Angiologie VZ AR 16 |
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10.1016/j.jcin.2023.05.018 doi (DE-627)ELV062334921 (ELSEVIER)S1936-8798(23)00844-0 DE-627 ger DE-627 rda eng 610 VZ 44.85 bkl Garcia, Santiago verfasserin aut Transcatheter Treatment of Native Aortic Valve Regurgitation 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR.Objectives: The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve).Methods: A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm).Results: A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without the need for surgical conversion or a second transcatheter heart valve) was 81% (22 of 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience, leading to changes in valve design. At 30 days, there was 1 death, 1 stroke, and 3 new pacemakers (13%), and 88% of patients were in NYHA functional class I or II. No patient had residual AR of moderate or greater degree at 30 days.Conclusions: The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk. aortic regurgitation compassionate use transcatheter aortic valve replacement Ye, Jian verfasserin aut Webb, John verfasserin aut Reardon, Michael verfasserin aut Kleiman, Neal verfasserin aut Goel, Sachin verfasserin (orcid)0000-0001-6041-3876 aut Hatab, Taha verfasserin aut Fam, Neil verfasserin aut Peterson, Mark verfasserin aut Liauw, Samantha verfasserin aut Frisoli, Tiberio M. verfasserin aut Bashir, Hanad verfasserin aut Paige, Debra verfasserin aut Rock, Darlene verfasserin aut Schmidt, Christian verfasserin aut Jollis, James G. verfasserin aut Kereiakes, Dean J. verfasserin aut Enthalten in American College of Cardiology ; ID: gnd/1017722-X JACC Cardiovascular interventions New York, NY : Elsevier, 2008 16 Online-Ressource (DE-627)578539160 (DE-600)2452163-2 (DE-576)294403027 1876-7605 nnns volume:16 GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 44.85 Kardiologie Angiologie VZ AR 16 |
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10.1016/j.jcin.2023.05.018 doi (DE-627)ELV062334921 (ELSEVIER)S1936-8798(23)00844-0 DE-627 ger DE-627 rda eng 610 VZ 44.85 bkl Garcia, Santiago verfasserin aut Transcatheter Treatment of Native Aortic Valve Regurgitation 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR.Objectives: The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve).Methods: A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm).Results: A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without the need for surgical conversion or a second transcatheter heart valve) was 81% (22 of 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience, leading to changes in valve design. At 30 days, there was 1 death, 1 stroke, and 3 new pacemakers (13%), and 88% of patients were in NYHA functional class I or II. No patient had residual AR of moderate or greater degree at 30 days.Conclusions: The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk. aortic regurgitation compassionate use transcatheter aortic valve replacement Ye, Jian verfasserin aut Webb, John verfasserin aut Reardon, Michael verfasserin aut Kleiman, Neal verfasserin aut Goel, Sachin verfasserin (orcid)0000-0001-6041-3876 aut Hatab, Taha verfasserin aut Fam, Neil verfasserin aut Peterson, Mark verfasserin aut Liauw, Samantha verfasserin aut Frisoli, Tiberio M. verfasserin aut Bashir, Hanad verfasserin aut Paige, Debra verfasserin aut Rock, Darlene verfasserin aut Schmidt, Christian verfasserin aut Jollis, James G. verfasserin aut Kereiakes, Dean J. verfasserin aut Enthalten in American College of Cardiology ; ID: gnd/1017722-X JACC Cardiovascular interventions New York, NY : Elsevier, 2008 16 Online-Ressource (DE-627)578539160 (DE-600)2452163-2 (DE-576)294403027 1876-7605 nnns volume:16 GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 44.85 Kardiologie Angiologie VZ AR 16 |
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10.1016/j.jcin.2023.05.018 doi (DE-627)ELV062334921 (ELSEVIER)S1936-8798(23)00844-0 DE-627 ger DE-627 rda eng 610 VZ 44.85 bkl Garcia, Santiago verfasserin aut Transcatheter Treatment of Native Aortic Valve Regurgitation 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR.Objectives: The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve).Methods: A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm).Results: A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without the need for surgical conversion or a second transcatheter heart valve) was 81% (22 of 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience, leading to changes in valve design. At 30 days, there was 1 death, 1 stroke, and 3 new pacemakers (13%), and 88% of patients were in NYHA functional class I or II. No patient had residual AR of moderate or greater degree at 30 days.Conclusions: The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk. aortic regurgitation compassionate use transcatheter aortic valve replacement Ye, Jian verfasserin aut Webb, John verfasserin aut Reardon, Michael verfasserin aut Kleiman, Neal verfasserin aut Goel, Sachin verfasserin (orcid)0000-0001-6041-3876 aut Hatab, Taha verfasserin aut Fam, Neil verfasserin aut Peterson, Mark verfasserin aut Liauw, Samantha verfasserin aut Frisoli, Tiberio M. verfasserin aut Bashir, Hanad verfasserin aut Paige, Debra verfasserin aut Rock, Darlene verfasserin aut Schmidt, Christian verfasserin aut Jollis, James G. verfasserin aut Kereiakes, Dean J. verfasserin aut Enthalten in American College of Cardiology ; ID: gnd/1017722-X JACC Cardiovascular interventions New York, NY : Elsevier, 2008 16 Online-Ressource (DE-627)578539160 (DE-600)2452163-2 (DE-576)294403027 1876-7605 nnns volume:16 GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 44.85 Kardiologie Angiologie VZ AR 16 |
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Garcia, Santiago @@aut@@ Ye, Jian @@aut@@ Webb, John @@aut@@ Reardon, Michael @@aut@@ Kleiman, Neal @@aut@@ Goel, Sachin @@aut@@ Hatab, Taha @@aut@@ Fam, Neil @@aut@@ Peterson, Mark @@aut@@ Liauw, Samantha @@aut@@ Frisoli, Tiberio M. @@aut@@ Bashir, Hanad @@aut@@ Paige, Debra @@aut@@ Rock, Darlene @@aut@@ Schmidt, Christian @@aut@@ Jollis, James G. @@aut@@ Kereiakes, Dean J. @@aut@@ |
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2023-01-01T00:00:00Z |
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<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">ELV062334921</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230927085301.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230830s2023 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/j.jcin.2023.05.018</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)ELV062334921</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ELSEVIER)S1936-8798(23)00844-0</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rda</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">610</subfield><subfield code="q">VZ</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.85</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Garcia, Santiago</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Transcatheter Treatment of Native Aortic Valve Regurgitation</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2023</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zzz</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Background: Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR.Objectives: The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve).Methods: A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm).Results: A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). 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Garcia, Santiago |
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Garcia, Santiago ddc 610 bkl 44.85 misc aortic regurgitation misc compassionate use misc transcatheter aortic valve replacement Transcatheter Treatment of Native Aortic Valve Regurgitation |
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610 VZ 44.85 bkl Transcatheter Treatment of Native Aortic Valve Regurgitation aortic regurgitation compassionate use transcatheter aortic valve replacement |
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ddc 610 bkl 44.85 misc aortic regurgitation misc compassionate use misc transcatheter aortic valve replacement |
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Transcatheter Treatment of Native Aortic Valve Regurgitation |
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Transcatheter Treatment of Native Aortic Valve Regurgitation |
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Garcia, Santiago Ye, Jian Webb, John Reardon, Michael Kleiman, Neal Goel, Sachin Hatab, Taha Fam, Neil Peterson, Mark Liauw, Samantha Frisoli, Tiberio M. Bashir, Hanad Paige, Debra Rock, Darlene Schmidt, Christian Jollis, James G. Kereiakes, Dean J. |
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Garcia, Santiago |
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10.1016/j.jcin.2023.05.018 |
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verfasserin |
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transcatheter treatment of native aortic valve regurgitation |
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Transcatheter Treatment of Native Aortic Valve Regurgitation |
| abstract |
Background: Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR.Objectives: The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve).Methods: A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm).Results: A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without the need for surgical conversion or a second transcatheter heart valve) was 81% (22 of 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience, leading to changes in valve design. At 30 days, there was 1 death, 1 stroke, and 3 new pacemakers (13%), and 88% of patients were in NYHA functional class I or II. No patient had residual AR of moderate or greater degree at 30 days.Conclusions: The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk. |
| abstractGer |
Background: Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR.Objectives: The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve).Methods: A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm).Results: A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without the need for surgical conversion or a second transcatheter heart valve) was 81% (22 of 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience, leading to changes in valve design. At 30 days, there was 1 death, 1 stroke, and 3 new pacemakers (13%), and 88% of patients were in NYHA functional class I or II. No patient had residual AR of moderate or greater degree at 30 days.Conclusions: The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk. |
| abstract_unstemmed |
Background: Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR.Objectives: The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve).Methods: A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm).Results: A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without the need for surgical conversion or a second transcatheter heart valve) was 81% (22 of 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience, leading to changes in valve design. At 30 days, there was 1 death, 1 stroke, and 3 new pacemakers (13%), and 88% of patients were in NYHA functional class I or II. No patient had residual AR of moderate or greater degree at 30 days.Conclusions: The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk. |
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| title_short |
Transcatheter Treatment of Native Aortic Valve Regurgitation |
| remote_bool |
true |
| author2 |
Ye, Jian Webb, John Reardon, Michael Kleiman, Neal Goel, Sachin Hatab, Taha Fam, Neil Peterson, Mark Liauw, Samantha Frisoli, Tiberio M. Bashir, Hanad Paige, Debra Rock, Darlene Schmidt, Christian Jollis, James G. Kereiakes, Dean J. |
| author2Str |
Ye, Jian Webb, John Reardon, Michael Kleiman, Neal Goel, Sachin Hatab, Taha Fam, Neil Peterson, Mark Liauw, Samantha Frisoli, Tiberio M. Bashir, Hanad Paige, Debra Rock, Darlene Schmidt, Christian Jollis, James G. Kereiakes, Dean J. |
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c |
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| doi_str |
10.1016/j.jcin.2023.05.018 |
| up_date |
2024-07-06T18:39:50.843Z |
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1803856055731486720 |
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