Five-year follow-up after percutaneous pulmonary valve implantation using the Venus P-valve system for patients with pulmonary regurgitation and an enlarged native right ventricular outflow tract.

BACKGROUND: Percutaneous pulmonary valve implantation (PPVI) with the self-expandable Venus P-valve system is a promising treatment for patients with pulmonary regurgitation (PR) and a native right ventricular outflow tract (RVOT). However, limited data is available regarding its midterm outcomes. This study assessed the midterm clinical and echocardiographic outcomes following Venus P-valve implantation. METHODS: From 2013 to 2018, 55 patients with moderate or severe PR after surgical RVOT repair with a transannular or RVOT patch were consecutively enrolled from six hospitals in China. Five-year clinical and echocardiographic outcomes were collected and evaluated. The primary endpoint was a freedom from all-cause mortality and reintervention. RESULTS: At 5 years, the primary endpoint was met for 96% of patients, corresponding to a freedom from all-cause mortality of 96% (95% confidence interval [CI]: 86%-99%) and freedom from reintervention of 98% (95% CI: 87%-100%). Endocarditis was reported in five patients (four patients within 1 year and one patient at 5 years) following PPVI. Transpulmonary gradient and stent orifice diameter remained stable compared to at discharge (p＞0.05). No paravalvular leak was reported while only 1 patient gradually increased to moderate PR during follow-up. Significant improvement of RV diameter and LVEF (p＜0.001) sustained over the 5-year follow-up, in consistent with remarked improved New York Heart Association(NYHA) functional class (p＜0.001). CONCLUSION: The 5-year results of the China VenusP Study demonstrated the midterm benefits of Venus P-valve implantation in the management of patients with severe PR with an enlarged native RVOT by providing sustained symptomatic and hemodynamic improvement.

Large-range lithography nano-alignment without phase unwrapping by a dual-frequency moiré fringe heterodyne.

Moiré fringe is an effective approach to realize nano-alignment. However, affected by short periodicity and phase unwrapping, moiré fringe technology has small alignment ranges and redundant algorithms, making it difficult to meet practical application requirements. To solve the problem, we propose a large-range lithography nano-alignment method without phase unwrapping by a dual-frequency moiré fringe heterodyne. This method obtains four sets of moiré fringes from the main and differential alignment marks and then calculates the misalignment information using the heterodyne method. In this approach, both large alignment range and high alignment accuracy are achieved while avoiding the phase unwrapping process. The experimental results verified the rationality and feasibility of the proposed method.

Efficient Fourier single-pixel imaging based on weighted sorting.

Fourier single-pixel imaging (FSI) has attracted increased attention in recent years with the advantages of a wide spectrum range and low cost. FSI reconstructs a scene by directly measuring the Fourier coefficients with a single-pixel detector. However, the existing sampling method is difficult to balance the noise suppression and image details within a limited number of measurements. Here we propose a new sampling strategy for FSI to solve this problem. Both the generality of the spectral distribution of natural images in the Fourier domain and the uniqueness of the spectral distribution of the target images in the Fourier domain are considered in the proposed method. These two distributions are summed with certain weights to determine the importance of the Fourier coefficients. Then these coefficients are sampled in order of decreasing importance. Both the simulations and experiments demonstrate that the proposed method can capture more key Fourier coefficients and retain more details with lower noise. The proposed method provides an efficient way for Fourier coefficient acquisition.

Novel arm-width-expandable transcatheter edge-to-edge repair system: Preclinical experiment and first-in-human study.

BACKGROUND: The ValveClasp system is a novel transcatheter edge-to-edge repair (TEER) device with an arm-width-expandable clip that allows treatment of patients with only one clip more frequently. OBJECTIVES: This study aimed to evaluate the feasibility and safety of a novel TEER device in porcine models and patients. METHODS: Fourteen young adult pigs were enrolled. A clip with an expanded arm was implanted under epicardial echocardiography and fluoroscopy guidance. Five patients with at least moderate-to-severe mitral regurgitation underwent TEER using the ValveClasp system to test the safety and effectiveness of the device. RESULTS: The device success rate was 100% (14/14) in the animal experiments, and all clips were deployed at the A2P2 segments, forming a double-orifice mitral valve. Gross observations on day 180 showed a wide and continuous tissue bridge between the leaflets. The acute procedural success rate was 100% (5/5). Only one clip was required in all patients, and all achieved effective postoperative endpoints (grade ≤2+). During 30-day follow-up, no adverse events occurred. All patients' vena Contracta width (from 8.04 0.71 mm to 3.84 ± 1.18 mm, p = 0.012), mitral regurgitation area (from 12.75 ± 3.13 cm2 to 3.50 ± 1.66 cm2 , p = 0.008), and left ventricular end diastolic diameter (from 52.00 ± 2.92 mm to 46.00 ± 3.08 mm, p = 0.040) were considerably decreased, without obvious mitral stenosis. CONCLUSIONS: The novel arm-width-expandable ValveClasp device is safe for TEER for treating severe mitral regurgitation.

High-order spatial phase shift method realizes modulation analysis through a single-frame image.

For the modulation-based structured illumination microscopy system, how to obtain modulation distribution with an image has been a research hotspot. However, the existing frequency-domain single-frame algorithms (mainly including the Fourier transform method, wavelet method, etc.) suffer from different degrees of analytical error due to the loss of high-frequency information. Recently, a modulation-based spatial area phase-shifting method was proposed; it can obtain higher precision by retaining high-frequency information effectively. But for discontinuous (such as step) topography, it would be somewhat smooth. To solve the problem, we propose a high-order spatial phase shift algorithm that realizes robust modulation analysis of a discontinuous surface with a single-frame image. At the same time, this technique proposes a residual optimization strategy, so that it can be applied to the measurement of complex topography, especially discontinuous topography. Simulation and experimental results demonstrate that the proposed method can provide higher-precision measurement.

Transcatheter edge to edge repair using the ease-of-use valve clamp system for functional mitral regurgitation: a primary report.

PURPOSE: The ValveClamp system is a novel edge-to-edge mitral valve repair system designed for the ease of operation. We report the outcomes of our initial experience of treating functional mitral regurgitation (MR) with the ValveClamp system. METHODS: The subjects of this study were patients with symptomatic functional MR despite standard medical therapy, who were treated with transapical ValveClamp implantation. The patients were divided into an atrial functional mitral regurgitation (AFMR) group and a ventricular functional mitral regurgitation (VFMR) group. Clinical and echocardiographic outcomes were evaluated at baseline and then at the 3-month follow up. RESULTS: Twelve patients, with a median age of 71 years (range 65-78 years), were assigned to the AFMR group (n = 5) or the VFMR group (n = 7). The device implantation rate was 100%, and 10 (83.3%) patients required implantation of only one clamp. The catheter time was less than 10 min in half of the patients, the fastest time being 5 min. There were no procedure-related complications. At the 3-month follow up, all patients were free from all-cause mortality, surgery, and rehospitalization. MR improved to ≤ 2 + in all 12 patients with MR grade 3 + or 4 + at baseline, (100%) and to ≤ 1 + in 9 of these patients (75%), with a low-pressure gradient. The left atrial diameter and the left ventricular end diastolic diameter decreased significantly in both the AFMR and VFMR groups. The left ventricular eject fraction at the 3-month follow up showed a rising trend in both the AFMR and VFMR groups, whereas PASP decreased remarkably. All 12 patients with baseline NYHA functional class III/IV (100%) showed improvement of at least 1 class, and 2 of these patients (16.7%) showed improvement of at least 2 classes. CONCLUSIONS: The ValveClamp system is simple and effective for transapical transcatheter edge to edge repair in patients with functional MR.

Motion-resolved real-time 4D flow MRI with low-rank and subspace modeling.

PURPOSE: To develop a new motion-resolved real-time four-dimensional (4D) flow MRI method, which enables the quantification and visualization of blood flow velocities with three-directional flow encodings and volumetric coverage without electrocardiogram (ECG) synchronization and respiration control. METHODS: An integrated imaging method is presented for real-time 4D flow MRI, which encompasses data acquisition, image reconstruction, and postprocessing. The proposed method features a specialized continuous ( k , t ) $$ \left(\mathbf{k},t\right) $$ -space acquisition scheme, which collects two sets of data (i.e., training data and imaging data) in an interleaved manner. By exploiting strong spatiotemporal correlation of 4D flow data, it reconstructs time-series images from highly-undersampled ( k , t ) $$ \left(\mathbf{k},t\right) $$ -space measurements with a low-rank and subspace model. Through data-binning-based postprocessing, it constructs a five-dimensional dataset (i.e., x-y-z-cardiac-respiratory), from which respiration-dependent flow information is further analyzed. The proposed method was evaluated in aortic flow imaging experiments with ten healthy subjects and two patients with atrial fibrillation. RESULTS: The proposed method achieves 2.4 mm isotropic spatial resolution and 34.4 ms temporal resolution for measuring the blood flow of the aorta. For the healthy subjects, it provides flow measurements in good agreement with those from the conventional 4D flow MRI technique. For the patients with atrial fibrillation, it is able to resolve beat-by-beat pathological flow variations, which cannot be obtained from the conventional technique. The postprocessing further provides respiration-dependent flow information. CONCLUSION: The proposed method enables high-resolution motion-resolved real-time 4D flow imaging without ECG gating and respiration control. It is able to resolve beat-by-beat blood flow variations as well as respiration-dependent flow information.

Feasibility Study of a Novel Transcatheter Tricuspid Annuloplasty System in a Porcine Model.

Gradually, more attention has been paid to tricuspid regurgitation. Formerly the "forgotten valvular heart disease," it has been recognized as having high incidence and adverse prognosis if untreated. However, isolated tricuspid valve surgery carries substantial risk and is thus not recommended. The K-Clip transcatheter tricuspid annuloplasty system has recently emerged as a minimally invasive therapeutic option that may help address these unmet clinical needs. The K-Clip technology simulates the Kay's procedure, which reduces the dimensions of the tricuspid annulus by folding and clamping the tricuspid annulus issue with a rigid clamping device. The feasibility of the K-Clip technology was investigated in this study, and annulus area reduction and declining tricuspid regurgitation grades were noted following the procedure. The findings of this study suggest that the K-Clip system may potentially be applicable as a novel transcatheter tricuspid annuloplasty device for the treatment of severe tricuspid in humans.

Efficacy of interatrial shunt devices: an opening window to acute pulmonary hypertensive crisis and chronic pulmonary arterial hypertension.

The current study aimed to elucidate the efficacy of interatrial shunt device (IASD) for the treatment of acute pulmonary hypertensive crisis (PHC) and chronic pulmonary arterial hypertension (PAH). After establishing chronic PAH models using dehydrogenized monocrotaline (DHMCT), PAH dogs were implanted with IASDs (group A) or received no intervention (group B). One month later, DHMCT was injected again to establish an acute PHC. The prognosis, hemodynamics, ultrasound cardiography, electrocardiogram, and lung pathology of the dogs were observed. The baseline mean pulmonary arterial pressure increased from 12.70 ± 1.03 to 19.95 ± 1.75 mmHg and established a chronic PAH model 2 months after DHMCT injection (1.50 mg/kg). After an additional injection of DHMCT (1.50 mg/kg) in the chronic PAH model, acute PHC occurred. Mean PAP, sPAP, and pulmonary vascular resistance increased to 22.67 ± 1.80 mmHg, 35.70 ± 1.66 mmHg, and 12.50 ± 3.50 WOOD U, respectively. Cardiac output (CO) decreased to 1.31 ± 0.26 L/min, and the right-to-left shunt caused hypoxemia. The survival rates of the dogs with and those without IASD were 70.0% and 22.2% (P = 0.037), respectively. Six months after PHC, the CO between the dogs with and those without IASD were 1.44 ± 0.11 L/min and 1.18 ± 0.04 L/min (P = 0.028). The long-term survival rates were 50.0% and 22.2%, respectively (P = 0.21). IASD might be efficacious and beneficial for treating acute PHC and chronic PAH, as well as improving prognosis.

Transcatheter Mitral Valve Edge-to-Edge Repair with a Novel System.

The ValveClamp system is a novel edge-to-edge mitral valve repair system that is designed for ease of operation. We aimed to report the 1-year outcomes of the early feasibility study of this system.Patients with severe degenerative mitral regurgitation (MR) at higher surgical risk and who received transapical ValveClamp implantation were followed for 1 year for clinical and echocardiographic outcomes.Twelve patients (mean age, 76.5 ± 6.3 years; mean Society of Thoracic Surgery score, 6.9 ± 1.9%) were enrolled at three sites in China. At 1 year, no patient died, received reoperation, or had long-term complications. Of the 12 patients with MR of 3+ or 4+ at baseline, 11 patients (91.67%) remained with MR ≤ 2+ at 1 year, and no patient had mitral stenosis. Significant reductions in maximum MR area (from 15.1 ± 6.51 cm2 to 4.45 ± 1.85 cm2, P < 0.001), effective orifice area (from 4.34 ± 0.34 cm2 to 2.38 ± 0.45 cm2, P < 0.001), and vena contracta width (from 8.03 ± 1.11 to 3.38 ± 2.11 mm, P < 0.001) were observed. The left cardiac dimensions were decreased, especially the mitral valve annulus diameter (from 34.79 ± 4.27 mm to 31.42 ± 2.81 mm, P < 0.05). Of the 12 patients with baseline New York Heart Association functional class III/IV, all patients experienced an improvement of at least one class (P < 0.05).Our study provides evidence that transapical ValveClamp implantation in high-risk patients with severe degenerative MR is safe and feasible, with good efficacy in the mid-long term.

Effect of iloprost on biomarkers in patients with congenital heart disease-pulmonary arterial hypertension.

Some biomarkers play important roles in the endothelial dysfunction of patients with pulmonary arterial hypertension (PAH), including nitric oxide (NO), endothelin-1 (ET-1), asymmetric dimethylarginine (ADMA), galectin-3 (Gal-3), B-type natriuretic peptide (BNP), and uric acid (UA). However, studies on these biomarkers in pulmonary artery blood in congenital heart disease-PAH (CHD-PAH) and the effect of iloprost on the regulation of biomarkers are lacking. This study investigated potential CHD-PAH biomarkers and their association with the severity of disease. The effect of iloprost on the regulation of these biomarkers was also studied. A total of 31 patients with CHD-PAH were enrolled. Seven with positive effects of iloprost (the average reduction in mPAP 11.13±1.73 mm Hg) and 19 with negative effects of iloprost (the average reduction in mPAP 4.21±4.87 mm Hg; iloprost positive group [IPG] vs iloprost negative group [ING], P<.01) and five age-matched controls were studied. The pulmonary artery blood sample was collected before and after inhaling iloprost, and the plasma concentrations of Gal-3, ADMA, ET-1, and NO were measured. A significant positive linear relationship was observed between mPAP and plasma ET-1, BNP, ADMA, and UA levels in all patients with CHD-PAH. ET-1, ADMA, BNP, and UA levels had a significant linear relationship with mean pulmonary arterial pressure, which could be used to predict the severity of CHD-PAH. ET-1 might be a potential biomarker to pre-evaluate the effect of iloprost on CHD-PAH. Iloprost could affect the expression of Gal-3 and, therefore, the process of fibrosis could be influenced by iloprost.