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.
OBJECTIVE
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.


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.
St. Thomas' Hospital, London, United Kingdom.
Martyn
M
Thomas
Christoph A
CA
Nienaber
Hüseyin
H
Ince
Andrejs
A
Erglis
Vladan
V
Vukcevic
Ulrich
U
Schäfer
Rui Cruz
RC
Ferreira
Stefan
S
Hardt
Stefan
S
Verheye
Vasco
V
Gama Ribeiro
Lissa
L
Sugeng
Corrado
C
Tamburino
D000368:Aged; D056988:Anterior Wall Myocardial Infarction / Q000150:complications* / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005060:Europe; D005080:Exercise Test; D017079:Exercise Tolerance; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006439:Hemodynamics; D006801:Humans; D017379:Hypertrophy, Left Ventricular / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D020127:Recovery of Function; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left; D020257:Ventricular Remodeling