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

Abstract

Aims: 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 anteriorapical 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. Clinical registration: www.clinicaltrials.gov numbers are NCT01297296 (PARACHUTE III) and NCT01286116 (cohort B subjects). KEYWORDS• ischaemic heart failure • left ventricle remodelling • structural heart

First‐in‐man study of Heartech® percutaneous left ventricular partitioning device for treatment of heart failure postmyocardial infarction

“…This study was the first‐in‐man trial showing that the PVR with Heartech® LVPD may be a desirable device for reducing LV volume and improving LV function in patients with HF post‐MI. The short‐term clinical outcomes were consistent with those of previous studies examining the Parachute® LVPD …”

Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure

“…One key observation in the hemodynamic response of the Chinese patients versus previously published Parachute data is the much greater improvement in systolic function, specifically EF and end systolic volume index. [56] A likely theory may be that the Chinese patients were treated earlier in the progression of HF (i.e., NYHA II) whereby the basal and mid LV function responded better to a reduction in wall stress and improvement in synchronized contraction.…”

İleri evre kalp yetersizliği rehberi

“…[343] Öte yandan, özellikle yaygın anterior AMI sonrası akinetik-anevrizmatik bölgeyi izole edip geometriyi ve dolayısıyla sol kalbin boşalmasını toparlayan cihaz çalışmaları PARACHUTE çalışmaları olarak bilinmektedir ve özel endikasyonda etkili ve güvenli olduğu gösterilmiştir. [344] İKY tedavisinde en fazla ümit beslenen alanlardan bir tanesi, KY'de bozulmuş olan sempato-vagal dengeyi düzeltmeye yöne-lik tedavi yaklaşımıdır. [345] Ancak gerek NECTAR-HF çalışması [346] gerekse INOVATE-HF çalışması [347] bekleneni vermemiştir.…”

“…[354] Kardiyak kök hücrelerin farklılaşma ve parakrin etkilerinin diğer kök hücrelerden daha iyi olduğunu gösteren hayvan çalışmaları vardır. [344] Kök hücre tedavisinde 3. nesil tedavi hücresiz-hücresel tedavi üzerinde odaklanmaya başlamıştır. Bu noktada birinci yolak, hücre destek sistemleri ile ikinci nesil kök hücre tedavisinin iyileştirilmesi, ikinci yolak, kök hücre tedavisinde etkili olan kimyasal-biyolojik materyallerin (eksozom, mikroRNA vs) hüc-resel elemanlar olmaksızın uygulanması üzerinde iler- lemektedir.…”