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Catheter Cardiovasc Interv ; 82(5): E718-25, 2013 Nov 01.
Article in English | MEDLINE | ID: mdl-23592588

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. MATERIAL AND 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]. CONCLUSION: 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.


Subject(s)
Cardiac Catheterization/instrumentation , Heart Failure/therapy , Patient Selection , Aged , Cardiac Catheterization/adverse effects , Echocardiography , Feasibility Studies , Female , Germany , Heart Failure/diagnosis , Heart Failure/etiology , Heart Failure/physiopathology , Humans , Imaging, Three-Dimensional , Male , Middle Aged , Multidetector Computed Tomography , Myocardial Infarction/complications , Predictive Value of Tests , Prospective Studies , Radiographic Image Interpretation, Computer-Assisted , Recovery of Function , Stroke Volume , Time Factors , Treatment Outcome , Ventricular Function, Left
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