title: Challenges in patient selection for the parachute device implantation.
abstract: BACKGROUND
  A novel percutaneous ventricular restoration therapy (PVRT) has been recently proposed to treat patients with ischemic heart failure (IHF) and antero-apical regional wall motion abnormalities after myocardial infarction (MI). In this prospective, single center, non-randomized study, we herein propose safety and feasibility evaluation of the device, in which a different patient selection strategy was used.
  
  
  METHODS
  A three-stage evaluation was adopted in a series of patients referred for a Parachute Ventricular Partitioning Device (Parachute™). After an initial clinical evaluation, a secondary screening step was performed according to echocardiographic functional (LVEF<40%, apical/anterior akinesia/dyskinesia) and anatomical criteria [diameter of LV-apex (LVAD) = 4.0 × 5.0 cm, left ventricular end diastolic diameter (LVEDD)>56 mm, left ventricular end systolic diameter (LVESD)>38 mm]. Patients encountering the echocardiographic criteria were selected for 3D cardiac CT (architecture, geometry, and trabeculation of the left ventricle) and eventually treated with the Parachute™.
  
  
  RESULTS
  Fifty patients were screened according to the echocardiographic criteria. Twenty-seven of those that met the echo inclusion criteria underwent further cardiac CT imaging. After CT imaging, eight patients were scheduled for Parachute™ implantation. The device was successfully implanted in all eight patients with no in-hospital mortality. A 3-month follow-up echocardiography showed LV-volume reduction [95% CI; LVEDV: -76.5 (-116; -36.8), P = 0.002 and LVESV: -47.4 (-63.8; -30.9), P = 0.003] and improvement of global EF [95% CI; global EF: 6.87 (5.36; 8.39), P = 0.008].
  
  
  CONCLUSIONS
  Selection criteria for Parachute™ placement should include left ventricular functional and anatomical parameters. When preprocedural echocardiography and cardiac CT are adequately implemented, satisfactory periprocedural and short term follow-up results may be achieved after Parachute™ implantation.
authors.affiliation: Department of Internal Medicine, Division of Cardiology, University Hospital Rostock, Germany.
authors.forename: Ilkay
authors.initials: I
authors.lastname: Bozdag-Turan
authors.forename: Benjamin
authors.initials: B
authors.lastname: Bermaoui
authors.forename: Liliya
authors.initials: L
authors.lastname: Paranskaya
authors.forename: R
authors.initials: R
authors.lastname: GökmenTuran
authors.forename: Giuseppe
authors.initials: G
authors.lastname: D'Ancona
authors.forename: Stephan
authors.initials: S
authors.lastname: Kische
authors.forename: Ralph
authors.initials: R
authors.lastname: Birkemeyer
authors.forename: Bojan
authors.initials: B
authors.lastname: Jovanovic
authors.forename: Jan
authors.initials: J
authors.lastname: Schuetz
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Akin
authors.forename: Cem Hakan
authors.initials: CH
authors.lastname: Turan
authors.forename: Jasmin
authors.initials: J
authors.lastname: Ortak
authors.forename: K
authors.initials: K
authors.lastname: Hauenstein
authors.forename: Cristoph Anton
authors.initials: CA
authors.lastname: Nienaber
authors.forename: Hueseyin
authors.initials: H
authors.lastname: Ince
mesh_terms: D000368:Aged; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D004452:Echocardiography; D005240:Feasibility Studies; D005260:Female; D005858:Germany; D006333:Heart Failure / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D021621:Imaging, Three-Dimensional; D008297:Male; D008875:Middle Aged; D061330:Multidetector Computed Tomography; D009203:Myocardial Infarction / Q000150:complications; D018579:Patient Selection; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011857:Radiographic Image Interpretation, Computer-Assisted; D020127:Recovery of Function; D013318:Stroke Volume; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left
keywords: PVRT; ParachuteTM; echocardiographic criteria; ischemic heart failure; ventricular partitioning device