Safety and effectiveness of a novel balloon-in-basket pulsed-field ablation catheter for the treatment of paroxysmal and persistent AF: Volt-AF IDE trial acute results.

Background: Increasing use of Pulsed Field Ablation (PFA) to treat atrial fibrillation (AF) has led to concerns related to tissue contact, hemolysis, and electroanatomic mapping integration. A novel balloon-in-basket PFA catheter offers form and function to address these concerns.

Objective: The VOLT-AF Investigational Device Exemption (IDE) study is a prospective, single-arm global IDE study designed to demonstrate the Volt PFA system (Abbott Laboratories, Chicago, Illinois) is safe and effective for the treatment of paroxysmal AF (PAF) and persistent AF (PersAF).

Multipoint pacing is associated with reduction of heart failure hospitalizations or death in patients who do not respond to cardiac resynchronization therapy: results of the MORE-CRT MPP randomized trial.

Aims: Cardiac resynchronization therapy (CRT) via biventricular pacing (BIVP) is an effective treatment, but non-responders are at a higher risk of death and heart failure (HF) hospitalizations compared with CRT responders. The MORE-CRT MPP trial aimed to evaluate whether CRT with multipoint pacing (MPP) is associated with improved clinical outcomes in CRT non-responders.

Methods And Results: Cardiac resynchronization therapy patients were treated with conventional BIVP for 6 months and then assessed for CRT response (left ventricular end-systolic volume relative reduction >15% vs.

Heart Size Difference Drives Sex-Specific Response to Cardiac Resynchronization Therapy: A Post Hoc Analysis of the MORE-MPP CRT Trial.

Background: Studies have reported that female sex predicts superior cardiac resynchronization therapy (CRT) response. One theory is that this association is related to smaller female heart size, thus increased relative dyssynchrony at a given QRS duration (QRSd). Our objective was to investigate the mechanisms of sex-specific CRT response relating to heart size, relative dyssynchrony, cardiomyopathy type, QRS morphology, and other patient characteristics.

A microneedle patch realizes weight loss through photothermal induction of fat browning.

As a globally prevalent disease, obesity leads to many chronic diseases, so it is important to develop safe and effective treatments with fewer side effects and lasting weight loss. In this study, we developed a biodegradable hyaluronic acid microneedle patch loaded with polydopamine nanoparticles and mirabegron, which directly acted on subcutaneous white adipose tissue, and then induced browning of white adipose tissue through mild photothermal therapy. The approach showed excellent browning-promoting ability and biocompatibility.

Heart size disparity drives sex-specific response to cardiac resynchronization therapy: a post-hoc analysis of the MORE-MPP CRT trial.

Background: Studies have reported that female sex predicts superior cardiac resynchronization therapy (CRT) response. One theory is that this association is related to smaller female heart size, thus increased "relative dyssynchrony" at given QRS durations (QRSd).

Objective: To investigate the mechanisms of sex-specific CRT response relating to heart size, relative dyssynchrony, cardiomyopathy type, QRS morphology, and other patient characteristics.

Avoiding unnecessary ventricular pacing is associated with reduced incidence of heart failure hospitalizations and persistent atrial fibrillation in pacemaker patients.

Aims: In bradycardia patients treated with dual-chamber pacing, we aimed to evaluate whether pacing with atrioventricular (AV) delay management [AV hysteresis (AVH)], compared with standard pacing with fixed AV delays, reduces unnecessary ventricular pacing percentage (VPP) and is associated with better clinical outcomes. Main study endpoints were the incidence of heart failure hospitalizations (HFH), persistent atrial fibrillation (AF), and cardiac death.

Methods And Results: Data from two identical prospective observational studies, BRADYCARE I in the USA and BRADYCARE II in Europe, Africa, and Asia, were pooled.

New insertable cardiac monitors show high diagnostic yield and good safety profile in real-world clinical practice: results from the international prospective observational SMART Registry.

Aims: Insertable cardiac monitors (ICMs) are indicated for long-term monitoring of unexplained syncope or palpitations, and for detection of bradycardia, ventricular tachycardia, and/or atrial fibrillation (AF). The aim of our study was to evaluate the safety and clinical value associated with a new generation ICM (Confirm Rx™, Abbott, Illinois, USA), featuring a new remote monitoring system based on smartphone patient applications.

Methods And Results: The SMART Registry is an international prospective observational study.

Advances and perspective on the translational medicine of biodegradable metals.

Biodegradable metals, designed to be safely degraded and absorbed by the body after fulfil the intended functions, are of particular interest in the 21 century. The marriage of advanced biodegradable metals with clinical needs have yield unprecedented possibility. Magnesium, iron, and zinc-based materials constitute the main components of temporary, implantable metallic medical devices.

PDLLA-Zn-nitrided Fe bioresorbable scaffold with 53-μm-thick metallic struts and tunable multistage biodegradation function.

Balancing the biodegradability and mechanical integrity of a bioresorbable scaffold (BRS) with time after implantation to match the remodeling of the scaffolded blood vessel is important, but a key challenge in doing so remains. This study presents a novel intercalated structure of a metallic BRS by introducing a nanoscale Zn sacrificial layer between the nitrided Fe platform and the sirolimus-carrying poly(d,l-lactide) drug coating. The PDLLA-Zn-FeN BRS shows a multistage biodegradation behavior, maintaining mechanical integrity at the initial stage and exhibiting accelerated biodegradation at the subsequent stage in both rabbit abdominal aortas and human coronary arteries, where complete biodegradation was observed about 2 years after implantation.

In vivo degradation and endothelialization of an iron bioresorbable scaffold.

Detection of in vivo biodegradation is critical for development of next-generation medical devices such as bioresorbable stents or scaffolds (BRSs). In particular, it is urgent to establish a nondestructive approach to examine in vivo degradation of a new-generation coronary stent for interventional treatment based on mammal experiments; otherwise it is not available to semi-quantitatively monitor biodegradation in any clinical trial. Herein, we put forward a semi-quantitative approach to measure degradation of a sirolimus-eluting iron bioresorbable scaffold (IBS) based on optical coherence tomography (OCT) images; this approach was confirmed to be consistent with the present weight-loss measurements, which is, however, a destructive approach.

Long-Term Efficacy of Biodegradable Metal-Polymer Composite Stents After the First and the Second Implantations into Porcine Coronary Arteries.

A biodegradable coronary stent is expected to eliminate the adverse events of an otherwise eternally implanting material after vessel remodeling. Both biocorrodible metals and biodegradable polymers have been tried as the matrix of the new-generation stent. Herein, we utilized a metal-polymer composite material to combine the advantages of the high mechanical strength of metals and the adjustable degradation rate of polymers to prepare the biodegradable stent.

Magnetic resonance (MR) safety and compatibility of a novel iron bioresorbable scaffold.

Fully bioresorbable scaffolds have been designed to overcome the limitations of traditional drug-eluting stents (DESs), which permanently cage the native vessel wall and pose possible complications. The ultrathin-strut designed sirolimus-eluting iron bioresorbable coronary scaffold system (IBS) shows comparable mechanical properties to traditional DESs and exhibits an adaptive degradation profile during target vessel healing, which makes it a promising candidate in all-comers patient population. For implanted medical devices, magnetic resonance (MR) imaging properties, including MR safety and compatibility, should be evaluated before its clinical use, especially for devices with intrinsic ferromagnetism.

Alloying design of biodegradable zinc as promising bone implants for load-bearing applications.

Magnesium-based biodegradable metals (BMs) as bone implants have better mechanical properties than biodegradable polymers, yet their strength is roughly less than 350 MPa. In this work, binary Zn alloys with alloying elements Mg, Ca, Sr, Li, Mn, Fe, Cu, and Ag respectively, are screened systemically by in vitro and in vivo studies. Li exhibits the most effective strengthening role in Zn, followed by Mg.

Enhanced Osseointegration of Zn-Mg Composites by Tuning the Release of Zn Ions with Sacrificial Mg-Rich Anode Design.

Relatively slow degradation rate and delayed osseointegration induced by excessive release of Zn ions are two main disadvantages of the use of pure Zn ion bioabsorbable orthopedic implants. In light of this, we designed a cathodic protection strategy by incorporating Mg, acting as a sacrificial anode, into Zn to form Zn-Mg composites. The performance of novel Zn-Mg composites with regard to degradation behavior and biocompatibility was evaluated systematically under and conditions.

In vitro and in vivo studies on zinc-hydroxyapatite composites as novel biodegradable metal matrix composite for orthopedic applications.

Unlabelled: Recent studies indicate that there is a great demand to optimize pure Zn with tunable degradation rates and more desirable biocompatibility as orthopedic implants. Metal matrix composite (MMC) can be a promising approach for this purpose. In this study, MMC with pure Zn as a matrix and hydroxyapatite (HA) as reinforcements were prepared by spark plasma sintering (SPS).

Strategy of Metal-Polymer Composite Stent To Accelerate Biodegradation of Iron-Based Biomaterials.

The new principle and technique to tune biodegradation rates of biomaterials is one of the keys to the development of regenerative medicine and next-generation biomaterials. Biodegradable stents are new-generation medical devices applied in percutaneous coronary intervention, etc. Recently, both corrodible metals and degradable polymers have drawn much attention in biodegradable stents or scaffolds.

Evolution of the degradation mechanism of pure zinc stent in the one-year study of rabbit abdominal aorta model.

In the present study, pure zinc stents were implanted into the abdominal aorta of rabbits for 12 months. Multiscale analysis including micro-CT, scanning electron microscopy (SEM), scanning transmission electron microscopy (STEM) and histological stainings was performed to reveal the fundamental degradation mechanism of the pure zinc stent and its biocompatibility. The pure zinc stent was able to maintain mechanical integrity for 6 months and degraded 41.

Long-term in vivo corrosion behavior, biocompatibility and bioresorption mechanism of a bioresorbable nitrided iron scaffold.

Unlabelled: Pure iron as a potential bioresorbable material for bioresorbable coronary scaffold has major disadvantages of slow corrosion and bioresorption. However, so far, there are neither quantitative data of long-term in vivo corrosion nor direct experimental evidence for bioresorption of pure iron and its alloys, which are fundamental and vital for developing novel Fe-based alloys overcoming the intrinsic drawbacks of pure iron. This work systemically investigated scaffold performance, long-term in vivo corrosion behavior and biocompatibility of a nitrided iron coronary scaffold and explored its bioresorption mechanism.

Racial and Ethnic Disparities in Diabetes Care and Impact of Vendor-Based Disease Management Programs.

Objective: We examined the existence of disparities in receipt of appropriate diabetes care among California's fee-for-service Medicaid beneficiaries and the effectiveness of a telephonic-based disease management program delivered by a disease management vendor on the reduction of racial/ethnic disparities in diabetes care.

Research Design And Methods: We conducted an intervention-control cohort study to test the effectiveness of a 3-year-long disease management program delivered to Medicaid fee-for-service beneficiaries aged 22 to 75 with a diagnosis of diabetes in Los Angeles and Alameda counties. The outcome measures were the receipt of at least one hemoglobin A1c (HbA1c) test, LDL cholesterol test, and retinal examination each year.

Cytotoxicity and its test methodology for a bioabsorbable nitrided iron stent.

Comprehensive assessments of the cytotoxicity of nitrided iron, a promising bioabsorbable metallic material, were conducted using in vitro methods. Extracting and standing experiments were conducted to determine the factors influencing the precipitation of the extract during extraction and incubation. The MTT method, fluorescent staining, and direct contact method were used to explore the in vitro cytotoxicity of nitrided iron stent extracts, nitrided iron foils, and their bulk corrosion products.

Characterization and in vivo evaluation of a bio-corrodible nitrided iron stent.

A bio-corrodible nitrided iron stent was developed using a vacuum plasma nitriding technique. In the nitrided iron stents, the tensile strength, radial strength, stiffness and in vitro electrochemical corrosion rate were significantly increased compared with those of the control pure iron stent. To evaluate its performance in vivo, the deployment of the nitrided iron stents in juvenile pig iliac arteries was performed.

Better outcomes, lower costs: palliative care program reduces stress, costs of care for children with life-threatening conditions.

This policy brief examines the Partners for Children (PFC) program--California's public pediatric community-based palliative care benefit to children living with life-threatening conditions and their families. Preliminary analysis of administrative and survey data indicates that participation in the PFC program improves quality of life for the child and family. In addition, participation in the program resulted in a one-third reduction in the average number of days spent in the hospital.

Ti-Ge binary alloy system developed as potential dental materials.

As-cast Ti-xGe (x = 2, 5, 10, 20 wt %) binary alloys were produced in this work, and various experiments were carried out to investigate the microstructure, mechanical properties, in vitro electrochemical and immersion corrosion behaviors as well as cytotoxicity with as-cast pure Ti as control, aiming to study the feasibility of Ti-xGe alloy system as potential dental materials. The microstructure of Ti-xGe alloys changes from single α-Ti phase to α-Ti + Ti(5)Ge(3) precipitation phase with the increase of Ge content. Mechanical tests show that Ti-5Ge alloy has the best comprehensive mechanical properties.