Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study
Aim The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). Materials and Methods From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1...
Ausführliche Beschreibung
Autor*in: |
Ierardi, Anna Maria [verfasserIn] |
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E-Artikel |
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Englisch |
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2023 |
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Anmerkung: |
© Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023. corrected publication 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
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Übergeordnetes Werk: |
Enthalten in: CardioVascular and interventional radiology - Berlin : Springer, 1978, 46(2023), 7 vom: 24. Mai, Seite 827-834 |
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Übergeordnetes Werk: |
volume:46 ; year:2023 ; number:7 ; day:24 ; month:05 ; pages:827-834 |
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DOI / URN: |
10.1007/s00270-023-03463-5 |
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SPR05215212X |
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520 | |a Aim The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). Materials and Methods From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5–7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected. Results VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders (p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p: 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management. Conclusion Our study suggests a better outcome with the same complication rate, except that for AVF incidence for non-balloon collagen plug device if compared to balloon occluders vascular closure devices. | ||
700 | 1 | |a Coppola, Andrea |4 aut | |
700 | 1 | |a Renzulli, Matteo |4 aut | |
700 | 1 | |a Piacentino, Filippo |4 aut | |
700 | 1 | |a Fontana, Federico |4 aut | |
700 | 1 | |a Paladini, Andrea |4 aut | |
700 | 1 | |a Guzzardi, Giuseppe |4 aut | |
700 | 1 | |a Semeraro, Vittorio |4 aut | |
700 | 1 | |a Di Stasi, Carmine |4 aut | |
700 | 1 | |a Giurazza, Francesco |4 aut | |
700 | 1 | |a Niola, Raffaella |4 aut | |
700 | 1 | |a Stefanini, Matteo |4 aut | |
700 | 1 | |a Contegiacomo, Andrea |4 aut | |
700 | 1 | |a Carrubba, Claudio |4 aut | |
700 | 1 | |a Discalzi, Andrea |4 aut | |
700 | 1 | |a Ciferri, Fernanda |4 aut | |
700 | 1 | |a Carriero, Serena |4 aut | |
700 | 1 | |a Lanza, Carolina |4 aut | |
700 | 1 | |a Biondetti, Pierpaolo |4 aut | |
700 | 1 | |a Coniglio, Giovanni |4 aut | |
700 | 1 | |a Fonio, Paolo |4 aut | |
700 | 1 | |a Venturini, Massimo |4 aut | |
700 | 1 | |a Carrafiello, Gianpaolo |4 aut | |
700 | 1 | |a Del Giudice, Costantino |4 aut | |
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10.1007/s00270-023-03463-5 doi (DE-627)SPR05215212X (SPR)s00270-023-03463-5-e DE-627 ger DE-627 rakwb eng Ierardi, Anna Maria verfasserin (orcid)0000-0002-3033-9713 aut Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023. corrected publication 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Aim The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). Materials and Methods From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5–7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected. Results VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders (p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p: 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management. Conclusion Our study suggests a better outcome with the same complication rate, except that for AVF incidence for non-balloon collagen plug device if compared to balloon occluders vascular closure devices. Coppola, Andrea aut Renzulli, Matteo aut Piacentino, Filippo aut Fontana, Federico aut Paladini, Andrea aut Guzzardi, Giuseppe aut Semeraro, Vittorio aut Di Stasi, Carmine aut Giurazza, Francesco aut Niola, Raffaella aut Stefanini, Matteo aut Contegiacomo, Andrea aut Carrubba, Claudio aut Discalzi, Andrea aut Ciferri, Fernanda aut Carriero, Serena aut Lanza, Carolina aut Biondetti, Pierpaolo aut Coniglio, Giovanni aut Fonio, Paolo aut Venturini, Massimo aut Carrafiello, Gianpaolo aut Del Giudice, Costantino aut Enthalten in CardioVascular and interventional radiology Berlin : Springer, 1978 46(2023), 7 vom: 24. Mai, Seite 827-834 (DE-627)253390451 (DE-600)1458490-6 1432-086X nnns volume:46 year:2023 number:7 day:24 month:05 pages:827-834 https://dx.doi.org/10.1007/s00270-023-03463-5 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 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_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_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 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_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 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_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 46 2023 7 24 05 827-834 |
spelling |
10.1007/s00270-023-03463-5 doi (DE-627)SPR05215212X (SPR)s00270-023-03463-5-e DE-627 ger DE-627 rakwb eng Ierardi, Anna Maria verfasserin (orcid)0000-0002-3033-9713 aut Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023. corrected publication 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Aim The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). Materials and Methods From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5–7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected. Results VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders (p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p: 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management. Conclusion Our study suggests a better outcome with the same complication rate, except that for AVF incidence for non-balloon collagen plug device if compared to balloon occluders vascular closure devices. Coppola, Andrea aut Renzulli, Matteo aut Piacentino, Filippo aut Fontana, Federico aut Paladini, Andrea aut Guzzardi, Giuseppe aut Semeraro, Vittorio aut Di Stasi, Carmine aut Giurazza, Francesco aut Niola, Raffaella aut Stefanini, Matteo aut Contegiacomo, Andrea aut Carrubba, Claudio aut Discalzi, Andrea aut Ciferri, Fernanda aut Carriero, Serena aut Lanza, Carolina aut Biondetti, Pierpaolo aut Coniglio, Giovanni aut Fonio, Paolo aut Venturini, Massimo aut Carrafiello, Gianpaolo aut Del Giudice, Costantino aut Enthalten in CardioVascular and interventional radiology Berlin : Springer, 1978 46(2023), 7 vom: 24. Mai, Seite 827-834 (DE-627)253390451 (DE-600)1458490-6 1432-086X nnns volume:46 year:2023 number:7 day:24 month:05 pages:827-834 https://dx.doi.org/10.1007/s00270-023-03463-5 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 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_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_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 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_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 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_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 46 2023 7 24 05 827-834 |
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10.1007/s00270-023-03463-5 doi (DE-627)SPR05215212X (SPR)s00270-023-03463-5-e DE-627 ger DE-627 rakwb eng Ierardi, Anna Maria verfasserin (orcid)0000-0002-3033-9713 aut Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023. corrected publication 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Aim The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). Materials and Methods From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5–7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected. Results VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders (p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p: 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management. Conclusion Our study suggests a better outcome with the same complication rate, except that for AVF incidence for non-balloon collagen plug device if compared to balloon occluders vascular closure devices. Coppola, Andrea aut Renzulli, Matteo aut Piacentino, Filippo aut Fontana, Federico aut Paladini, Andrea aut Guzzardi, Giuseppe aut Semeraro, Vittorio aut Di Stasi, Carmine aut Giurazza, Francesco aut Niola, Raffaella aut Stefanini, Matteo aut Contegiacomo, Andrea aut Carrubba, Claudio aut Discalzi, Andrea aut Ciferri, Fernanda aut Carriero, Serena aut Lanza, Carolina aut Biondetti, Pierpaolo aut Coniglio, Giovanni aut Fonio, Paolo aut Venturini, Massimo aut Carrafiello, Gianpaolo aut Del Giudice, Costantino aut Enthalten in CardioVascular and interventional radiology Berlin : Springer, 1978 46(2023), 7 vom: 24. Mai, Seite 827-834 (DE-627)253390451 (DE-600)1458490-6 1432-086X nnns volume:46 year:2023 number:7 day:24 month:05 pages:827-834 https://dx.doi.org/10.1007/s00270-023-03463-5 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 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_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_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 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_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 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_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 46 2023 7 24 05 827-834 |
allfieldsGer |
10.1007/s00270-023-03463-5 doi (DE-627)SPR05215212X (SPR)s00270-023-03463-5-e DE-627 ger DE-627 rakwb eng Ierardi, Anna Maria verfasserin (orcid)0000-0002-3033-9713 aut Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023. corrected publication 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Aim The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). Materials and Methods From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5–7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected. Results VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders (p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p: 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management. Conclusion Our study suggests a better outcome with the same complication rate, except that for AVF incidence for non-balloon collagen plug device if compared to balloon occluders vascular closure devices. Coppola, Andrea aut Renzulli, Matteo aut Piacentino, Filippo aut Fontana, Federico aut Paladini, Andrea aut Guzzardi, Giuseppe aut Semeraro, Vittorio aut Di Stasi, Carmine aut Giurazza, Francesco aut Niola, Raffaella aut Stefanini, Matteo aut Contegiacomo, Andrea aut Carrubba, Claudio aut Discalzi, Andrea aut Ciferri, Fernanda aut Carriero, Serena aut Lanza, Carolina aut Biondetti, Pierpaolo aut Coniglio, Giovanni aut Fonio, Paolo aut Venturini, Massimo aut Carrafiello, Gianpaolo aut Del Giudice, Costantino aut Enthalten in CardioVascular and interventional radiology Berlin : Springer, 1978 46(2023), 7 vom: 24. Mai, Seite 827-834 (DE-627)253390451 (DE-600)1458490-6 1432-086X nnns volume:46 year:2023 number:7 day:24 month:05 pages:827-834 https://dx.doi.org/10.1007/s00270-023-03463-5 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 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_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_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 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_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 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_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 46 2023 7 24 05 827-834 |
allfieldsSound |
10.1007/s00270-023-03463-5 doi (DE-627)SPR05215212X (SPR)s00270-023-03463-5-e DE-627 ger DE-627 rakwb eng Ierardi, Anna Maria verfasserin (orcid)0000-0002-3033-9713 aut Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023. corrected publication 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Aim The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). Materials and Methods From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5–7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected. Results VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders (p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p: 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management. Conclusion Our study suggests a better outcome with the same complication rate, except that for AVF incidence for non-balloon collagen plug device if compared to balloon occluders vascular closure devices. Coppola, Andrea aut Renzulli, Matteo aut Piacentino, Filippo aut Fontana, Federico aut Paladini, Andrea aut Guzzardi, Giuseppe aut Semeraro, Vittorio aut Di Stasi, Carmine aut Giurazza, Francesco aut Niola, Raffaella aut Stefanini, Matteo aut Contegiacomo, Andrea aut Carrubba, Claudio aut Discalzi, Andrea aut Ciferri, Fernanda aut Carriero, Serena aut Lanza, Carolina aut Biondetti, Pierpaolo aut Coniglio, Giovanni aut Fonio, Paolo aut Venturini, Massimo aut Carrafiello, Gianpaolo aut Del Giudice, Costantino aut Enthalten in CardioVascular and interventional radiology Berlin : Springer, 1978 46(2023), 7 vom: 24. Mai, Seite 827-834 (DE-627)253390451 (DE-600)1458490-6 1432-086X nnns volume:46 year:2023 number:7 day:24 month:05 pages:827-834 https://dx.doi.org/10.1007/s00270-023-03463-5 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 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_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_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 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_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 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_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 46 2023 7 24 05 827-834 |
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Enthalten in CardioVascular and interventional radiology 46(2023), 7 vom: 24. Mai, Seite 827-834 volume:46 year:2023 number:7 day:24 month:05 pages:827-834 |
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Ierardi, Anna Maria @@aut@@ Coppola, Andrea @@aut@@ Renzulli, Matteo @@aut@@ Piacentino, Filippo @@aut@@ Fontana, Federico @@aut@@ Paladini, Andrea @@aut@@ Guzzardi, Giuseppe @@aut@@ Semeraro, Vittorio @@aut@@ Di Stasi, Carmine @@aut@@ Giurazza, Francesco @@aut@@ Niola, Raffaella @@aut@@ Stefanini, Matteo @@aut@@ Contegiacomo, Andrea @@aut@@ Carrubba, Claudio @@aut@@ Discalzi, Andrea @@aut@@ Ciferri, Fernanda @@aut@@ Carriero, Serena @@aut@@ Lanza, Carolina @@aut@@ Biondetti, Pierpaolo @@aut@@ Coniglio, Giovanni @@aut@@ Fonio, Paolo @@aut@@ Venturini, Massimo @@aut@@ Carrafiello, Gianpaolo @@aut@@ Del Giudice, Costantino @@aut@@ |
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Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Aim The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). Materials and Methods From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5–7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected. Results VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders (p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p: 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management. 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Ierardi, Anna Maria Coppola, Andrea Renzulli, Matteo Piacentino, Filippo Fontana, Federico Paladini, Andrea Guzzardi, Giuseppe Semeraro, Vittorio Di Stasi, Carmine Giurazza, Francesco Niola, Raffaella Stefanini, Matteo Contegiacomo, Andrea Carrubba, Claudio Discalzi, Andrea Ciferri, Fernanda Carriero, Serena Lanza, Carolina Biondetti, Pierpaolo Coniglio, Giovanni Fonio, Paolo Venturini, Massimo Carrafiello, Gianpaolo Del Giudice, Costantino |
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Ierardi, Anna Maria |
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effectiveness and safety of different vascular closure devices: multicentre prospective observational study |
title_auth |
Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study |
abstract |
Aim The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). Materials and Methods From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5–7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected. Results VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders (p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p: 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management. Conclusion Our study suggests a better outcome with the same complication rate, except that for AVF incidence for non-balloon collagen plug device if compared to balloon occluders vascular closure devices. © Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023. corrected publication 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
abstractGer |
Aim The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). Materials and Methods From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5–7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected. Results VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders (p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p: 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management. Conclusion Our study suggests a better outcome with the same complication rate, except that for AVF incidence for non-balloon collagen plug device if compared to balloon occluders vascular closure devices. © Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023. corrected publication 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
abstract_unstemmed |
Aim The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). Materials and Methods From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5–7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected. Results VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders (p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p: 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management. Conclusion Our study suggests a better outcome with the same complication rate, except that for AVF incidence for non-balloon collagen plug device if compared to balloon occluders vascular closure devices. © Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023. corrected publication 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
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Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study |
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Coppola, Andrea Renzulli, Matteo Piacentino, Filippo Fontana, Federico Paladini, Andrea Guzzardi, Giuseppe Semeraro, Vittorio Di Stasi, Carmine Giurazza, Francesco Niola, Raffaella Stefanini, Matteo Contegiacomo, Andrea Carrubba, Claudio Discalzi, Andrea Ciferri, Fernanda Carriero, Serena Lanza, Carolina Biondetti, Pierpaolo Coniglio, Giovanni Fonio, Paolo Venturini, Massimo Carrafiello, Gianpaolo Del Giudice, Costantino |
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score |
7.399167 |