Percutaneous Ventricular Restoration Therapy Research Articles

P4887Acute hemodynamic and echocardiographic effects of percutaneous ventricular restoration therapy using the Parachute device in patients with severe ischemic cardiomyopathy: a single center experience

P4887Acute hemodynamic and echocardiographic effects of percutaneous ventricular restoration therapy using the Parachute device in patients with severe ischemic cardiomyopathy: a single center experience

Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study.

Background:The primary cause of ischemic heart failure (HF) is myocardial infarction (MI) resulting in left ventricle (LV) wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device (CardioKinetix, Inc., CA, USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI.Methods:Thirty-one patients with New York Heart Association (NYHA) Class II, III ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin for at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index (LVESVI) against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-5D and visual analog scale (VAS). For quantitative data comparison, paired t-test (normality data) and signed-rank test (abnormality data) were used; application of signed-rank test was for the ranked data comparison.Results:A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ± 20.0 ml/m2 to 53.1 ± 17.0 ml/m2 (P < 0.0001). The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than half a class at 3 months (P < 0.001). Quality of life assessed by the VAS value increased 11.5 points (P < 0.01), demonstrating improvement at 3 months.Conclusion:The favorable outcomes observed in the high-risk patients provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for ischemic HF patients.Trial Registration:ClinicalTrials.gov, NCT02240940; https://clinicaltrials.gov/ct2/show/NCT02240940.

Surgical Considerations for the Explantation of the Parachute Left Ventricular Partitioning Device and the Implantation of the Heartmate Ii Left Ventricular Assist Device

Chronic heart failure is the leading cause of death in the world. With newer therapies, the burden of this disease has decreased; however, a significant number of patients remain refractive to existing therapies. Myocardial infarction often leads to ventricular remodeling and eventually contributes to heart failure. The Parachute™ (Cardiokinetix, Menlo Park, CA) is the first device designed for percutaneous ventricular restoration therapy, which reduces left ventricular volume and minimizes the risk of open surgical procedures. For the first time, we report a case of explantation of the Parachute ventricular partitioning device and transition to a HeartMate II™ left ventricular assist device and the surgical considerations for a successful outcome.

Cardiac computed tomography assessment of the near term impact of percutaneous ventricular restoration therapy (parachute(®) ) on mitral valve geometry.

The aim of current study is to assess the near term impact of percutaneous ventricular restoration therapy (PVR), Parachute(®) on mitral valve (MV) geometry by cardiac computed tomography (CCT). Recent data demonstrates the feasibility of PVR for treatment of post anterior myocardial infarction (MI) heart failure. Little is known, however, about the interaction of the device and left ventricular structures, particularly the MV apparatus. This is a retrospective Core Laboratory analysis of Parachute Trials' CCT data. Patients with paired (before and after Parachute implant) CCT acquisitions were included into analysis. MV geometric parameters were measured. Thirty-three patients were included in the analysis. The mean time of follow-up CCT post procedure was 188 ± 52 days. There were significant reduction in tenting height (A1P1: -1.70 ± 1.89 mm, -17.40 ± 20.20%; A2P2: -1.43 ± 1.89 mm, -12.10 ± 15.00%; A3P3: -1.54 ± 1.58 mm, -15.50 ± 15.20%, P < 0.001), tenting volume (-0.93 ± 0.60 mm3, -22.00 ± 11.40%, P < 0.001), systolic interpapillary muscle distance (-2.22 ± 2.11 mm, -7.51 ± 7.23%, P < 0.001) and diastolic interpapillary muscle distance (-3.14 ± 2.20 mm, -8.46 ± 5.73%, P < 0.001) post PVR. In post anterior MI heart failure patients, PVR has favorable near term impact on MV geometry as assessed by CCT. © 2015 Wiley Periodicals, Inc.

Challenges in patient selection for the parachute device implantation

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. 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™. 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]. 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.

Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Patients With Ischemic Heart Failure and Dilated Left Ventricles: The U.S. Pivotal Trial Design

Left ventricle (LV) remodeling after anterior wall myocardial infarction leads to increased LV volumes, myocardial stress and ultimately heart failure (HF). Treatment options are limited for this high morbidity and mortality risk population. Randomized trials are needed to determine the effect of Percutaneous Ventricular Restoration Therapy (PVRT) in treatment of HF.

Comparison of the Predictive Values of NT-proBNP and Lung Impedance Measurements in the Course of BNP-Guided Treatment of CHF Patients

Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Patients With Ischemic Heart Failure and Dilated Left Ventricles: The U.S. Pivotal Trial Design William T. Abraham, Michael Pencia, Serjan Nikolic, Thomas Engels, Marco A. Costa; Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH; Harvard Clinical Research Institute, Harvard University, Boston, MA; Cardikinetix Inc., Menlo Park, CA; Division of Cardiology, Case Western Reserve University, Cleveland, OH