Percutaneous Ventricular Restoration Prevents Left Ventricular Remodeling Post Myocardial Infarction: One-Year Evaluation of the Heartech First-in-man Study.

BACKGROUND: This is first-in-man investigation of an implantable Heartech left ventricular partitioning device (LVPD) therapy for chronic heart failure (HF) after a myocardial infarction. METHODS AND RESULTS: Initially, 16 patients were chosen from 3 cardiac centers within China. All patients were treated with percutaneous ventricular restoration involving the Heartech LVPD implantation. Major adverse cardiovascular and cerebrovascular events were documented. Functional status, echocardiograph evaluation, European five-dimensional health scale, 6-minute walk test before the procedure and at postoperative follow-ups were recorded. We demonstrated successful implantation and device function with a success rate of 93.75%. One patient suffered a fatal myocardial infarction within the 12 ± 1 month follow-up. However, other patients did not report any major adverse cardiovascular and cerebrovascular events at their 12 ± 1 month follow-ups. After the operation, the average left ventricular end-systolic volume index decreased dramatically (66.00 mL/m2, interquartile range [IQR] 63.00-89.00 mL/m2 vs 48.00 mL/m2, IQR 32.25-68.25 mL/m2, P = .001), along with the left ventricular end-diastolic volume index (105.00 mL/m2, IQR 90.00-130.00 mL/m2 vs 76.50 mL/m2, IQR 57.75-120.25 mL/m2, P = .002). The left ventricular ejection fraction (35.00%, IQR 27.00-38.00% vs 42.50%, IQR 34.75-50.25%, P = .003), 6-minute walk test (383.13 ± 108.70 m vs 491.17 ± 118.44 m, P = .01), and European five-dimensional health scale (65.93 ± 11.25 vs 82.50 ± 5.44, P < .001), in turn, improved significantly. CONCLUSIONS: In our study, the Heartech LVPD was demonstrated as both safe and effective in reducing LV volume, enhancing LV function after implantation. These results remain constant at least till the 12 month follow-up. (Trial Registration: NCT02938637.).

Heartech® left ventricular partitioning device improves left ventricular systolic function of patients with chronic heart failure post-myocardial infarction at 1-year follow-up.

OBJECTIVES: This study presents 1-year follow-up data of echocardiographic outcomes in patients who received the Heartech® left ventricular (LV) partitioning device (LVPD) (Xinrui Medical Equipment Co. Ltd., Shanghai, China). BACKGROUND: Our first-in-man study of the Heartech® LVPD confirmed its safety and efficacy in patients with chronic heart failure (HF) post-myocardial infarction (MI) 1 month post-implantation. This subsequent study reports the echocardiographic outcomes of these patients at 1 year of follow-up. METHODS: Fifteen patients with HF post-MI from three cardiac intervention centers in China were successfully implanted with the Heartech® LVPD via percutaneous ventricular restoration procedures. Echocardiographic parameters-including LV systolic function, diastolic function, two-dimensional speckle-tracking analysis, and right ventricular systolic function-were obtained before device implantation and at 1 month and 1 year postoperatively. RESULTS: There was no deterioration of LV diastolic function, specific strain parameters, or right ventricular function at 1 year. Relative to the echocardiographic parameters recorded before the procedure, the LV ejection fraction (32.47 ± 6.98% vs. 42.5 ± 7.41%; p = .001) was significantly improved at 1 year, while the LV end-diastolic volume index (106.29 ± 28.01 vs. 83.30 ± 31.71; p = .005) and end-systolic volume index were significantly reduced (72.47 ± 22.77 vs. 50.00 ± 19.70; p = .001). CONCLUSIONS: One-year echocardiographic follow-up results confirmed that no deterioration of LV diastolic function or specific strain parameters was observed and LV systolic function was significantly improved in patients with HF post-MI who were implanted with the Heartech® LVPD.

A novel recyclable left ventricular partitioning device.

Percutaneous ventricular restoration is an established treatment that is used in left ventricle (LV) patients with anteroapical regional wall motion abnormality, dilated LV, systolic dysfunction after anterior myocardial infarction, and poor LV ejection fraction of heart failure. A ventricular partitioning device (VPD), which can be delivered percutaneously through the aortic valve, was placed at the apex of the LV. We aimed at improving the LV hemodynamics by isolating the dysfunctional apical region. Existing VPDs used in clinics are not recyclable. If the physician must extract the device owing to disease development, the patient must undergo thoracotomy. It is well known that thoracotomy is a high-risk operation. It may even cause patients to die. Therefore, we propose a recyclable left VPD that can be remove through a recovery snare after the device is implanted into the patient's ventricle. Such novel recyclable VPD could effectively avoid thoracotomy, thus resulting in favorable outcomes with reassuring safety.

A novel inflatable left ventricular partitioning device.

Percutaneous ventricular restoration (PVR) is an established treatment for patients with combined ischemic coronary artery disease and hear failure (HF). The left ventricle (LV) partitioning device is an interventional medical device that can be implanted into the ventricles of patients to reduce LV volumes, resulting in improved LV remodeling. However, the isolation surface area of the device is invariant, while the LV size of each patient is different. Thus, we designed a novel inflatable LV partitioning device. The functional volume of our ventricular isolation device can be adjusted by inflating and exhausting the device via the stomata based on a patient's ventricle size. The novel design could potentially reduce ventricular functional volume and improve the LV hemodynamic environment, thus resulting in favorable outcomes with reassuring safety and efficacy.

First-in-man study of Heartech® percutaneous left ventricular partitioning device for treatment of heart failure postmyocardial infarction.

OBJECTIVE: This first-in-man (FIM) study aimed to determine the safety and efficacy of the Heartech® left ventricular partitioning device (LVPD) in patients with chronic heart failure (HF) postmyocardial infarction. METHODS: Sixteen patients were enrolled from three cardiac intervention centers in China. All patients underwent percutaneous ventricular restoration (PVR) procedures with implantation of the Heartech® LVPD. Safety and immediate success rates were recorded. Major adverse cardiovascular and cerebrovascular events (MACCEs) including all-cause mortality, myocardial infarction, stroke, emergent or selective surgery or interventional therapy, renal failure requiring hemodialysis, and major bleeding were recorded. Efficacy features included functional status, echocardiographic characteristics, life quality characteristics including peak oxygen consumption of cardiopulmonary exercise testing (CPET), European five-dimensional health scale (EQ-5D), 6-min walk test (6MWT) at baseline and during follow-up (NCT02938637). RESULTS: The device success rate was 93.75% (15 successes in 16 patients) with 100% safety. During follow-up of 36 ± 4.5 days, no MACCEs were found. The left ventricular end-systolic volume index decreased significantly (LVESVi, 72.47 ± 22.77 mL/m2 vs. 50.13 ± 13.36 mL/m2 , p < .001) as did left ventricular end diastolic volume index (LVEDVi, 106.27 ± 28.01 mL/m2 vs. 83.20 ± 16.87 mL/m2 , p = .001). Left ventricular ejection fraction (LVEF, 32.47 ± 6.98% vs. 40.41 ± 6.15, p < .001), 6MWT (383.13 ± 108.70 vs. 453.47 ± 88.24, p < 0.001) and EQ-5D (65.93 ± 11.25 vs. 78.67 ± 8.35, p < .001) improved significantly. CONCLUSIONS: Heartech® LVPD appeared to be safe and effective for treatment of HF postmyocardial infarction.

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

OBJECTIVES: 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). BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: In post anterior MI heart failure patients, PVR has favorable near term impact on MV geometry as assessed by CCT. © 2015 Wiley Periodicals, Inc.