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Percutaneous Ventricular Restoration (PVR) Therapy Using the Parachute Device in 100 Subjects with Ischaemic Dilated Heart Failure: One-Year Primary Endpoint Results of PARACHUTE III, a European Trial

2015-10Journal article Open access
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dc.contributor.authorThomas, M
dc.contributor.authorNienaber, C
dc.contributor.authorInce, H
dc.contributor.authorErglis, A
dc.contributor.authorVukcevic, V
dc.contributor.authorSchäfer, U
dc.contributor.authorCruz Ferreira, R
dc.contributor.authorHardt, S
dc.contributor.authorVerheye, S
dc.contributor.authorGama Ribeiro, V
dc.contributor.authorSugeng, L
dc.contributor.authorTamburino, C
dc.date.accessioned2017-05-24T14:57:32Z
dc.date.available2017-05-24T14:57:32Z
dc.date.issued2015-10
dc.description.abstractAIMS: This prospective, non-randomised, observational study conducted in Europe was designed in order to assess the long-term safety and efficacy of the Parachute device in ischaemic heart failure subjects as a result of left ventricle remodelling after anterior wall myocardial infarction. METHODS AND RESULTS: One hundred subjects with New York Heart Association Class II-IV ischaemic heart failure (HF), ejection fraction (EF) between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularised were enrolled. The primary safety endpoint was procedural- or device-related major adverse cardiac cerebral events (MACCE). The secondary safety endpoint was the composite of mortality and morbidity. Secondary efficacy endpoints included haemodynamic measurements determined by echocardiography, LV volume indices, and assessment of functional improvement measured by a standardised six-minute walk test. Of the 100 subjects enrolled, device implantation was successful in 97 (97%) subjects. The one-year rates of the primary and secondary safety endpoints were 7% and 32.3%, respectively. The secondary endpoints, LV volume reduction (p<0.0001) and six-minute walk distance improvement (p<0.01), were achieved. CONCLUSIONS: The favourable outcomes observed in this high-risk population provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for HF subjects.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationEuroIntervention. 2015 Oct;11(6):710-7.pt_PT
dc.identifier.doi10.4244/EIJV11I6A143pt_PT
dc.identifier.urihttp://hdl.handle.net/10400.17/2687
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherEuropa Digital & Publishingpt_PT
dc.subjectAgedpt_PT
dc.subjectAnterior Wall Myocardial Infarctionpt_PT
dc.subjectCardiac Catheterizationpt_PT
dc.subjectEuropept_PT
dc.subjectExercise Testpt_PT
dc.subjectExercise Tolerancept_PT
dc.subjectFemalept_PT
dc.subjectHeart Failurept_PT
dc.subjectHemodynamicspt_PT
dc.subjectHumanspt_PT
dc.subjectHypertrophy, Left Ventricularpt_PT
dc.subjectKaplan-Meier Estimatept_PT
dc.subjectMalept_PT
dc.subjectMiddle Agedpt_PT
dc.subjectProspective Studiespt_PT
dc.subjectProsthesis Designpt_PT
dc.subjectProsthesis Implantationpt_PT
dc.subjectRecovery of Functionpt_PT
dc.subjectRisk Factorspt_PT
dc.subjectTime Factorspt_PT
dc.subjectTreatment Outcomept_PT
dc.subjectVentricular Function, Leftpt_PT
dc.subjectVentricular Remodelingpt_PT
dc.subjectHSM CARpt_PT
dc.titlePercutaneous Ventricular Restoration (PVR) Therapy Using the Parachute Device in 100 Subjects with Ischaemic Dilated Heart Failure: One-Year Primary Endpoint Results of PARACHUTE III, a European Trialpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage717pt_PT
oaire.citation.issue6pt_PT
oaire.citation.startPage710pt_PT
oaire.citation.titleEurointerventionpt_PT
oaire.citation.volume11pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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