Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study

Background: The primary cause of ischemic heart failure (HF) is myocardial infarction (MI) resulting in left ventricle (LV) wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device (CardioKinetix, Inc., CA, USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI. Methods: Thirty-one patients with New York Heart Association (NYHA) Class II, III ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin for at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index (LVESVI) against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-5D and visual analog scale (VAS). For quantitative data comparison, paired t-test (normality data) and signed-rank test (abnormality data) were used; application of signed-rank test was for the ranked data comparison. Results: A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ± 20.0 ml/m2 to 53.1 ± 17.0 ml/m2 (P < 0.0001). The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than half a class at 3 months (P < 0.001). Quality of life assessed by the VAS value increased 11.5 points (P < 0.01), demonstrating improvement at 3 months. Conclusion: The favorable outcomes observed in the high-risk patients provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for ischemic HF patients. Trial Registration: ClinicalTrials.gov, NCT02240940; https://clinicaltrials.gov/ct2/show/NCT02240940. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Yue-Jin Yang [verfasserIn] Yong Huo [verfasserIn] Ya-Wei Xu [verfasserIn] Jian-An Wang [verfasserIn] Ya-Ling Han [verfasserIn] Jun-Bo Ge [verfasserIn] Rui-Yan Zhang [verfasserIn] Xiao-Yan Yan [verfasserIn] Run-Lin Gao [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2016

Schlagwörter:	Ischemic Heart Failure; Left Ventricle Remodeling; Percutaneous Ventricular Restoration; Structural Heart

Übergeordnetes Werk:	In: Chinese Medical Journal - Wolters Kluwer, 2004, 129(2016), 17, Seite 2058-2062
Übergeordnetes Werk:	volume:129 ; year:2016 ; number:17 ; pages:2058-2062

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.4103/0366-6999.189048

Katalog-ID:	DOAJ046831991

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allfields	10.4103/0366-6999.189048 doi (DE-627)DOAJ046831991 (DE-599)DOAJebd7dd51b0c547bd82bad35272c5a04e DE-627 ger DE-627 rakwb eng Yue-Jin Yang verfasserin aut Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: The primary cause of ischemic heart failure (HF) is myocardial infarction (MI) resulting in left ventricle (LV) wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device (CardioKinetix, Inc., CA, USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI. Methods: Thirty-one patients with New York Heart Association (NYHA) Class II, III ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin for at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index (LVESVI) against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-5D and visual analog scale (VAS). For quantitative data comparison, paired t-test (normality data) and signed-rank test (abnormality data) were used; application of signed-rank test was for the ranked data comparison. Results: A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ± 20.0 ml/m2 to 53.1 ± 17.0 ml/m2 (P < 0.0001). The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than half a class at 3 months (P < 0.001). Quality of life assessed by the VAS value increased 11.5 points (P < 0.01), demonstrating improvement at 3 months. Conclusion: The favorable outcomes observed in the high-risk patients provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for ischemic HF patients. Trial Registration: ClinicalTrials.gov, NCT02240940; https://clinicaltrials.gov/ct2/show/NCT02240940. Ischemic Heart Failure; Left Ventricle Remodeling; Percutaneous Ventricular Restoration; Structural Heart Medicine R Yong Huo verfasserin aut Ya-Wei Xu verfasserin aut Jian-An Wang verfasserin aut Ya-Ling Han verfasserin aut Jun-Bo Ge verfasserin aut Rui-Yan Zhang verfasserin aut Xiao-Yan Yan verfasserin aut Run-Lin Gao verfasserin aut In Chinese Medical Journal Wolters Kluwer, 2004 129(2016), 17, Seite 2058-2062 (DE-627)363772693 (DE-600)2108782-9 25425641 nnns volume:129 year:2016 number:17 pages:2058-2062 https://doi.org/10.4103/0366-6999.189048 kostenfrei https://doaj.org/article/ebd7dd51b0c547bd82bad35272c5a04e kostenfrei http://www.cmj.org/article.asp?issn=0366-6999;year=2016;volume=129;issue=17;spage=2058;epage=2062;aulast=Yang kostenfrei https://doaj.org/toc/0366-6999 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 129 2016 17 2058-2062
spelling	10.4103/0366-6999.189048 doi (DE-627)DOAJ046831991 (DE-599)DOAJebd7dd51b0c547bd82bad35272c5a04e DE-627 ger DE-627 rakwb eng Yue-Jin Yang verfasserin aut Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: The primary cause of ischemic heart failure (HF) is myocardial infarction (MI) resulting in left ventricle (LV) wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device (CardioKinetix, Inc., CA, USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI. Methods: Thirty-one patients with New York Heart Association (NYHA) Class II, III ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin for at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index (LVESVI) against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-5D and visual analog scale (VAS). For quantitative data comparison, paired t-test (normality data) and signed-rank test (abnormality data) were used; application of signed-rank test was for the ranked data comparison. Results: A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ± 20.0 ml/m2 to 53.1 ± 17.0 ml/m2 (P < 0.0001). The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than half a class at 3 months (P < 0.001). Quality of life assessed by the VAS value increased 11.5 points (P < 0.01), demonstrating improvement at 3 months. Conclusion: The favorable outcomes observed in the high-risk patients provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for ischemic HF patients. Trial Registration: ClinicalTrials.gov, NCT02240940; https://clinicaltrials.gov/ct2/show/NCT02240940. Ischemic Heart Failure; Left Ventricle Remodeling; Percutaneous Ventricular Restoration; Structural Heart Medicine R Yong Huo verfasserin aut Ya-Wei Xu verfasserin aut Jian-An Wang verfasserin aut Ya-Ling Han verfasserin aut Jun-Bo Ge verfasserin aut Rui-Yan Zhang verfasserin aut Xiao-Yan Yan verfasserin aut Run-Lin Gao verfasserin aut In Chinese Medical Journal Wolters Kluwer, 2004 129(2016), 17, Seite 2058-2062 (DE-627)363772693 (DE-600)2108782-9 25425641 nnns volume:129 year:2016 number:17 pages:2058-2062 https://doi.org/10.4103/0366-6999.189048 kostenfrei https://doaj.org/article/ebd7dd51b0c547bd82bad35272c5a04e kostenfrei http://www.cmj.org/article.asp?issn=0366-6999;year=2016;volume=129;issue=17;spage=2058;epage=2062;aulast=Yang kostenfrei https://doaj.org/toc/0366-6999 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 129 2016 17 2058-2062
allfields_unstemmed	10.4103/0366-6999.189048 doi (DE-627)DOAJ046831991 (DE-599)DOAJebd7dd51b0c547bd82bad35272c5a04e DE-627 ger DE-627 rakwb eng Yue-Jin Yang verfasserin aut Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: The primary cause of ischemic heart failure (HF) is myocardial infarction (MI) resulting in left ventricle (LV) wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device (CardioKinetix, Inc., CA, USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI. Methods: Thirty-one patients with New York Heart Association (NYHA) Class II, III ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin for at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index (LVESVI) against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-5D and visual analog scale (VAS). For quantitative data comparison, paired t-test (normality data) and signed-rank test (abnormality data) were used; application of signed-rank test was for the ranked data comparison. Results: A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ± 20.0 ml/m2 to 53.1 ± 17.0 ml/m2 (P < 0.0001). The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than half a class at 3 months (P < 0.001). Quality of life assessed by the VAS value increased 11.5 points (P < 0.01), demonstrating improvement at 3 months. Conclusion: The favorable outcomes observed in the high-risk patients provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for ischemic HF patients. Trial Registration: ClinicalTrials.gov, NCT02240940; https://clinicaltrials.gov/ct2/show/NCT02240940. Ischemic Heart Failure; Left Ventricle Remodeling; Percutaneous Ventricular Restoration; Structural Heart Medicine R Yong Huo verfasserin aut Ya-Wei Xu verfasserin aut Jian-An Wang verfasserin aut Ya-Ling Han verfasserin aut Jun-Bo Ge verfasserin aut Rui-Yan Zhang verfasserin aut Xiao-Yan Yan verfasserin aut Run-Lin Gao verfasserin aut In Chinese Medical Journal Wolters Kluwer, 2004 129(2016), 17, Seite 2058-2062 (DE-627)363772693 (DE-600)2108782-9 25425641 nnns volume:129 year:2016 number:17 pages:2058-2062 https://doi.org/10.4103/0366-6999.189048 kostenfrei https://doaj.org/article/ebd7dd51b0c547bd82bad35272c5a04e kostenfrei http://www.cmj.org/article.asp?issn=0366-6999;year=2016;volume=129;issue=17;spage=2058;epage=2062;aulast=Yang kostenfrei https://doaj.org/toc/0366-6999 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 129 2016 17 2058-2062
allfieldsGer	10.4103/0366-6999.189048 doi (DE-627)DOAJ046831991 (DE-599)DOAJebd7dd51b0c547bd82bad35272c5a04e DE-627 ger DE-627 rakwb eng Yue-Jin Yang verfasserin aut Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: The primary cause of ischemic heart failure (HF) is myocardial infarction (MI) resulting in left ventricle (LV) wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device (CardioKinetix, Inc., CA, USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI. Methods: Thirty-one patients with New York Heart Association (NYHA) Class II, III ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin for at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index (LVESVI) against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-5D and visual analog scale (VAS). For quantitative data comparison, paired t-test (normality data) and signed-rank test (abnormality data) were used; application of signed-rank test was for the ranked data comparison. Results: A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ± 20.0 ml/m2 to 53.1 ± 17.0 ml/m2 (P < 0.0001). The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than half a class at 3 months (P < 0.001). Quality of life assessed by the VAS value increased 11.5 points (P < 0.01), demonstrating improvement at 3 months. Conclusion: The favorable outcomes observed in the high-risk patients provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for ischemic HF patients. Trial Registration: ClinicalTrials.gov, NCT02240940; https://clinicaltrials.gov/ct2/show/NCT02240940. Ischemic Heart Failure; Left Ventricle Remodeling; Percutaneous Ventricular Restoration; Structural Heart Medicine R Yong Huo verfasserin aut Ya-Wei Xu verfasserin aut Jian-An Wang verfasserin aut Ya-Ling Han verfasserin aut Jun-Bo Ge verfasserin aut Rui-Yan Zhang verfasserin aut Xiao-Yan Yan verfasserin aut Run-Lin Gao verfasserin aut In Chinese Medical Journal Wolters Kluwer, 2004 129(2016), 17, Seite 2058-2062 (DE-627)363772693 (DE-600)2108782-9 25425641 nnns volume:129 year:2016 number:17 pages:2058-2062 https://doi.org/10.4103/0366-6999.189048 kostenfrei https://doaj.org/article/ebd7dd51b0c547bd82bad35272c5a04e kostenfrei http://www.cmj.org/article.asp?issn=0366-6999;year=2016;volume=129;issue=17;spage=2058;epage=2062;aulast=Yang kostenfrei https://doaj.org/toc/0366-6999 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 129 2016 17 2058-2062
allfieldsSound	10.4103/0366-6999.189048 doi (DE-627)DOAJ046831991 (DE-599)DOAJebd7dd51b0c547bd82bad35272c5a04e DE-627 ger DE-627 rakwb eng Yue-Jin Yang verfasserin aut Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: The primary cause of ischemic heart failure (HF) is myocardial infarction (MI) resulting in left ventricle (LV) wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device (CardioKinetix, Inc., CA, USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI. Methods: Thirty-one patients with New York Heart Association (NYHA) Class II, III ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin for at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index (LVESVI) against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-5D and visual analog scale (VAS). For quantitative data comparison, paired t-test (normality data) and signed-rank test (abnormality data) were used; application of signed-rank test was for the ranked data comparison. Results: A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ± 20.0 ml/m2 to 53.1 ± 17.0 ml/m2 (P < 0.0001). The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than half a class at 3 months (P < 0.001). Quality of life assessed by the VAS value increased 11.5 points (P < 0.01), demonstrating improvement at 3 months. Conclusion: The favorable outcomes observed in the high-risk patients provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for ischemic HF patients. Trial Registration: ClinicalTrials.gov, NCT02240940; https://clinicaltrials.gov/ct2/show/NCT02240940. Ischemic Heart Failure; Left Ventricle Remodeling; Percutaneous Ventricular Restoration; Structural Heart Medicine R Yong Huo verfasserin aut Ya-Wei Xu verfasserin aut Jian-An Wang verfasserin aut Ya-Ling Han verfasserin aut Jun-Bo Ge verfasserin aut Rui-Yan Zhang verfasserin aut Xiao-Yan Yan verfasserin aut Run-Lin Gao verfasserin aut In Chinese Medical Journal Wolters Kluwer, 2004 129(2016), 17, Seite 2058-2062 (DE-627)363772693 (DE-600)2108782-9 25425641 nnns volume:129 year:2016 number:17 pages:2058-2062 https://doi.org/10.4103/0366-6999.189048 kostenfrei https://doaj.org/article/ebd7dd51b0c547bd82bad35272c5a04e kostenfrei http://www.cmj.org/article.asp?issn=0366-6999;year=2016;volume=129;issue=17;spage=2058;epage=2062;aulast=Yang kostenfrei https://doaj.org/toc/0366-6999 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 129 2016 17 2058-2062
language	English
source	In Chinese Medical Journal 129(2016), 17, Seite 2058-2062 volume:129 year:2016 number:17 pages:2058-2062
sourceStr	In Chinese Medical Journal 129(2016), 17, Seite 2058-2062 volume:129 year:2016 number:17 pages:2058-2062
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Ischemic Heart Failure; Left Ventricle Remodeling; Percutaneous Ventricular Restoration; Structural Heart Medicine R
isfreeaccess_bool	true
container_title	Chinese Medical Journal
authorswithroles_txt_mv	Yue-Jin Yang @@aut@@ Yong Huo @@aut@@ Ya-Wei Xu @@aut@@ Jian-An Wang @@aut@@ Ya-Ling Han @@aut@@ Jun-Bo Ge @@aut@@ Rui-Yan Zhang @@aut@@ Xiao-Yan Yan @@aut@@ Run-Lin Gao @@aut@@
publishDateDaySort_date	2016-01-01T00:00:00Z
hierarchy_top_id	363772693
id	DOAJ046831991
language_de	englisch
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A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device (CardioKinetix, Inc., CA, USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI. Methods: Thirty-one patients with New York Heart Association (NYHA) Class II, III ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin for at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index (LVESVI) against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-5D and visual analog scale (VAS). For quantitative data comparison, paired t-test (normality data) and signed-rank test (abnormality data) were used; application of signed-rank test was for the ranked data comparison. Results: A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ± 20.0 ml/m2 to 53.1 ± 17.0 ml/m2 (P < 0.0001). The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than half a class at 3 months (P < 0.001). 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author	Yue-Jin Yang
spellingShingle	Yue-Jin Yang misc Ischemic Heart Failure; Left Ventricle Remodeling; Percutaneous Ventricular Restoration; Structural Heart misc Medicine misc R Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study
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topic_title	Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study Ischemic Heart Failure; Left Ventricle Remodeling; Percutaneous Ventricular Restoration; Structural Heart
topic	misc Ischemic Heart Failure; Left Ventricle Remodeling; Percutaneous Ventricular Restoration; Structural Heart misc Medicine misc R
topic_unstemmed	misc Ischemic Heart Failure; Left Ventricle Remodeling; Percutaneous Ventricular Restoration; Structural Heart misc Medicine misc R
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title	Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study
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title_full	Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study
author_sort	Yue-Jin Yang
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author_browse	Yue-Jin Yang Yong Huo Ya-Wei Xu Jian-An Wang Ya-Ling Han Jun-Bo Ge Rui-Yan Zhang Xiao-Yan Yan Run-Lin Gao
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title_sort	percutaneous ventricular restoration therapy using the parachute device in chinese patients with ischemic heart failure: three-month primary end-point results of parachute china study
title_auth	Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study
abstract	Background: The primary cause of ischemic heart failure (HF) is myocardial infarction (MI) resulting in left ventricle (LV) wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device (CardioKinetix, Inc., CA, USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI. Methods: Thirty-one patients with New York Heart Association (NYHA) Class II, III ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin for at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index (LVESVI) against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-5D and visual analog scale (VAS). For quantitative data comparison, paired t-test (normality data) and signed-rank test (abnormality data) were used; application of signed-rank test was for the ranked data comparison. Results: A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ± 20.0 ml/m2 to 53.1 ± 17.0 ml/m2 (P < 0.0001). The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than half a class at 3 months (P < 0.001). Quality of life assessed by the VAS value increased 11.5 points (P < 0.01), demonstrating improvement at 3 months. Conclusion: The favorable outcomes observed in the high-risk patients provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for ischemic HF patients. Trial Registration: ClinicalTrials.gov, NCT02240940; https://clinicaltrials.gov/ct2/show/NCT02240940.
abstractGer	Background: The primary cause of ischemic heart failure (HF) is myocardial infarction (MI) resulting in left ventricle (LV) wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device (CardioKinetix, Inc., CA, USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI. Methods: Thirty-one patients with New York Heart Association (NYHA) Class II, III ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin for at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index (LVESVI) against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-5D and visual analog scale (VAS). For quantitative data comparison, paired t-test (normality data) and signed-rank test (abnormality data) were used; application of signed-rank test was for the ranked data comparison. Results: A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ± 20.0 ml/m2 to 53.1 ± 17.0 ml/m2 (P < 0.0001). The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than half a class at 3 months (P < 0.001). Quality of life assessed by the VAS value increased 11.5 points (P < 0.01), demonstrating improvement at 3 months. Conclusion: The favorable outcomes observed in the high-risk patients provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for ischemic HF patients. Trial Registration: ClinicalTrials.gov, NCT02240940; https://clinicaltrials.gov/ct2/show/NCT02240940.
abstract_unstemmed	Background: The primary cause of ischemic heart failure (HF) is myocardial infarction (MI) resulting in left ventricle (LV) wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device (CardioKinetix, Inc., CA, USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI. Methods: Thirty-one patients with New York Heart Association (NYHA) Class II, III ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin for at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index (LVESVI) against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-5D and visual analog scale (VAS). For quantitative data comparison, paired t-test (normality data) and signed-rank test (abnormality data) were used; application of signed-rank test was for the ranked data comparison. Results: A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ± 20.0 ml/m2 to 53.1 ± 17.0 ml/m2 (P < 0.0001). The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than half a class at 3 months (P < 0.001). Quality of life assessed by the VAS value increased 11.5 points (P < 0.01), demonstrating improvement at 3 months. Conclusion: The favorable outcomes observed in the high-risk patients provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for ischemic HF patients. Trial Registration: ClinicalTrials.gov, NCT02240940; https://clinicaltrials.gov/ct2/show/NCT02240940.
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title_short	Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study
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Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study

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