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.

In-hospital outcome of patients with severe mitral valve regurgitation classified as inoperable and treated with the MitraClip® device.

BACKGROUND: To evaluate the short-term outcome of patients predominantly at high risk treated with the MitraClip® device for severe mitral valve regurgitation (MR) using one or more clips. METHODS: We prospectively analyzed patients with highly symptomatic MR classified as inoperable (logistic EuroSCORE 24.16 ± 13.64%; STS-score 29.9 ± 14.5%) but subject to mitral valve repair with MitraClip® between May 2010 and January 2011. Thirty-three consecutive patients (57.6% male; age 77.8 ± 6.7 years) were enrolled and treated with either 1 (n = 7; 21.2%), 2 (n = 20; 60.6%), 3 (n = 4; 12.1%), or 4 (n = 2, 6.1%) clips. Grading of MR was performed by two-dimensional transesophageal echocardiography (2D-TEE) prior to TEE-guided clipping and before discharge. RESULTS: MR was classified as functional in 23 (69.7%) and organic in 10 (30.3%) of the patients with MR-grade ≥ 3+ in 32 (97%) and = 4 in 1 patients (3%) before repair. Reduction in MR grade to grade ≤1+ was achieved in 81.7% and to 2 in 12.1% (P = 0.00072). Invasive pulmonary artery systolic pressure (PAPsyst) and pulmonary capillary wedge pressure (PCWP) v-wave decreased from 59.2 ± 18.6 to 46.9 ± 15.3 mmHg (P = 0.00014) and 21.2 ± 6.7 to 8.0 ± 3.3 mmHg (P = 0.0093), respectively, as measured immediately after clipping. Functional NYHA class improved from mean 3 (range 3 [90.9%] to 4 [9.1%]) to 2 in 84.9% (P = 0.00081) as obtained at discharge. CONCLUSIONS: Mitral valve repair with MitraClip® using multiple clips is appropriate and safe in unselected patients resulting in reduced MR with positive impact on short-term functional capacity.

Improvement of cardiac function by intracoronary freshly isolated bone marrow cells transplantation in patients with acute myocardial infarction.

BACKGROUND: We analyzed in the present study the influence of intracoronary autologous freshly isolated bone marrow cells transplantation (BMCs-Tx) on cardiac function in patients with acute myocardial infarction (AMI). METHODS AND RESULTS: The 32 patients with AMI were enrolled in this prospective nonrandomized study to either freshly isolated BMC-Tx or to a control group without cell therapy. Global left ventricular ejection fraction (LVEF) and the size of infarct area were determined by left ventriculography. We observed in patients with autologous freshly isolated BMCs-Tx at 6 months follow up a significant reduction of infarct size as compared to control group. Moreover, we found a significant increase of LVEF as well as infarct wall movement velocity at 6 months follow up in cell therapy group as compared to control group. In the control group there was no significant difference of LVEF, infarct size and infarct wall movement velocity between baseline and 6 months after AMI. CONCLUSIONS: These results demonstrate for the first time that intracoronary transplantation of autologous freshly isolated BMCs by use of a point of care system is safe, and may lead to improvement of cardiac function in patients with AMI.

Improved mobilization of the CD34(+) and CD133(+) bone marrow-derived circulating progenitor cells by freshly isolated intracoronary bone marrow cell transplantation in patients with ischemic heart disease.

Cell therapy is a promising novel option for treatment of cardiovascular disease. Because the role of bone marrow-derived circulating progenitor cells (BM-CPCs) after cell therapy is less clear, we analyzed in this randomized, controlled study the influence of intracoronary autologous freshly isolated bone marrow cell transplantation (BMC-Tx) by using a point-of-care system on cardiac function and on the mobilization of BM-CPCs in patients with ischemic heart disease (IHD). Fifty-six patients with IHD were randomized to either receive freshly isolated BMC-Tx or a control group that did not receive cell therapy. Peripheral blood concentrations of CD34/45(+) and CD133/45(+) CPCs were measured by flow cytometry pre-, immediately post-, and at 3, 6, and 12 months postprocedure in both groups. Global ejection fraction and the size of infarct area were determined by left ventriculography. We observed in patients with IHD after intracoronary transplantation of autologous freshly isolated BMCs-Tx at 3 and 12 months follow-up a significant reduction of the size of infarct area and increase of global ejection fraction as well as infarct wall movement velocity. The mobilization of CD34/45(+) and CD133/45(+) BM-CPCs significantly increased at 3, 6, and 12 months after cell therapy when compared with baseline in patients with IHD, although no significant changes were observed between pre- and immediately postintracoronary cell therapy administration. In the control group without cell therapy, there was no significant difference of CD34/45(+) and CD133/45(+) BM-CPCs mobilization between pre- and at 3, 6, and 12 months postcoronary angiography. Intracoronary transplantation of autologous freshly isolated BMCs by using a point-of-care system in patients with IHD may enhance and prolong the mobilization of CD34/45(+) and CD133/45(+) BM-CPCs in peripheral blood and this might increase the regenerative potency in IHD.