Challenges in patient selection for the parachute device implantation.

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.

Mitral valve repair using multiple MitraClips®: a dobutamine stress echocardiography evaluation.

AIMS: The haemodynamic effect of mitral valve (MV) repair using multiple MitraClips® (MC) has not been investigated. The aim of the study was to evaluate the stress performance of MV repair with MC. METHODS AND RESULTS: Twenty consecutive patients (77±7 years, 13 men [65%]) after implantation of >2 MitraClips® were subsequently evaluated with dobutamine stress echocardiography (DSE). After MC implantation, mean transmitral pressure gradient (TPG) (3.3±0.8 mmHg vs. 4.0±0.6 mmHg; p<0.001) and mitral valve orifice area (2.9±0.3 cm2 vs. 3.9±0.4 cm2; p<0.001) were significantly increased during DSE showing a physiological behaviour effect of the MV. LVEF (41±18% vs. 46±21%; p<0.001) and systolic pulmonary artery pressure (42±11 mmHg vs. 44±12 mmHg; p=0.014) increased significantly. The degree of MR was stable during stress (p=0.68). At linear regression, only baseline peak TPG was related to stress mean TPG (p<0.001; Beta 0.816; 95% CI: 0.368-0.918). CONCLUSIONS: MV repair using MitraClips® should be performed with the aim of maximal reduction of MR degree. MV repair using MC may not lead to pathological degrees of MV stenosis. Although the TPG is significantly increased during stress, it never reaches pathological levels and is always accompanied by a significant increase in MVOA. The degree of residual MR remains unchanged during maximal pharmacological stress.