and closure device

OBJECTIVE: We aimed to evaluate the safety and efficacy of radiation dose reduction with a new-generation biplane angiocardiography system in patients undergoing transcatheter isolated patent ductus arteriosus (PDA) closure. MATERIALS AND METHODS: Fifty pediatric patients who underwent transcatheter PDA closure were randomly divided into two groups as normal radiation dose and low dose. Patients who required additional procedures other than PDA closure were excluded...

BACKGROUND: Transcatheter closure of the patent ductus arteriosus (PDA) in premature infants is currently dependent on fluoroscopic guidance and transportation to the catheterization laboratory. AIM: We describe a new echocardiographically guided technique to allow our team to move to the bedside at the neonatal intensive care unit (NICU) of the referring center for percutaneous treatment of PDA in premature infants. METHODS: This is a single-center, retrospective, primarily descriptive analysis...

4D (bio-)printing endows 3D printed (bio-)materials with multiple functionalities and dynamic properties. 4D printed materials have been recently used in biomedical engineering for the design and fabrication of biomedical devices, such as stents, occluders, micro-needles, smart 3D-cell engineered micro-environments, drug delivery systems, wound closures, and implantable medical devices. However, the success of 4D printing relies on the rational design of 4D printed objects, the selection of smart materials, and the availability of appropriate types of external (multi-)stimuli...

BACKGROUND: Left atrial appendage (LAA) closure is an alternative to chronic anticoagulation for stroke prevention in patients with nonvalvular atrial fibrillation. Multiple devices were used for LAA closure, with the Amplatzer Amulet LAA Occluder (Abbott, Chicago, IL, USA) and Watchman device (Boston Scientific, Marlborough, MA, USA) being the most commonly used in clinical practice. In August 2021, the FDA approved the use of the Amplatzer Amulet LAA Occluder. There is still a knowledge gap in the safety profile of the Amplatzer Amulet LAA Occluder device in comparison to the Watchman device...

Malignant tumors pose a significant threat to human life and well-being because of their rising occurrence and size. The current treatment methods and diagnostic techniques employed in clinical practice are inadequate for effectively treating tumors. Fluorescence, photothermal effects, radiosensitization, and biocompatibility are only a few instances of the unique photonic and physicochemical properties exhibited. Gold nanoclusters (AuNCs) are nanomaterials that possess modest dimensions, typically measuring approximately 3 nm, and are composed of a limited number of particles...

While achieving premarket approval from the US Food and Drug Administration represents a significant milestone in the development and commercialization of a Class III medical device, the aftermath endeavor of gaining market access can be daunting. This article provides a case study of the Barricaid annular closure device (Barricaid), a reherniation reduction device, which has been demonstrated to decrease the risk of suffering a recurrent lumbar intervertebral disc herniation. Following Food and Drug Administration approval, clinical adoption has been slow due to barriers to market access, including the perception of low-quality clinical evidence, questionable significance of the medical necessity of the procedure, and imaging evidence of increased likelihood of vertebral endplate changes...

OBJECTIVES: This retrospective study sought to determine the feasibility of transcatheter atrial septal defect device closure in patients less than 15 kg, as well as to assess complication rates and the reasons for unsuccessful device closure. BACKGROUND: In general, the risks associated with transcatheter atrial septal defect device closure are believed and reported to be relatively low, but the evidence stems from trials involving adults and older children. Current guidelines do not recommend atrial defect closure in device closure in children <15 kg, due to limited data available for feasibility and safety of device closure in this group of patients...

IMPORTANCE: Left atrial appendage elimination may improve catheter ablation outcomes for atrial fibrillation. OBJECTIVE: To assess the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to catheter pulmonary vein isolation for nonparoxysmal atrial fibrillation. DESIGN, SETTING, AND PARTICIPANTS: This multicenter, prospective, open-label, randomized clinical trial evaluated the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to planned pulmonary vein isolation for nonparoxysmal atrial fibrillation present for less than 3 years...

BACKGROUND: As the population ages, the rates of hip diseases and fragility fractures are increasing, making total hip arthroplasty (THA) one of the best methods for treating elderly patients. With the increasing number of THA surgeries and diverse surgical methods, there is a need for standard evaluation protocols. This study aimed to use deep learning algorithms to classify THA videos and evaluate the accuracy of the labelling of these videos. METHODS: In our study, we manually annotated 7 phases in THA, including skin incision, broaching, exposure of acetabulum, acetabular reaming, acetabular cup positioning, femoral stem insertion, and skin closure...

OBJECTIVE: To evaluate the efficacy of a new mechanochemical ablation (MOCA) device versus endovenous laser ablation (EVLA) for primary great saphenous vein (GSV) reflux. MATERIALS AND METHODS: Prospectively analyze the demographics, treatment detail and outcomes data of 57 primary GSV reflux patients. Patients were randomly assigned to MOCA or EVLA group with random envelope method. Primary endpoint was 6-month closure rate of GSV. Secondary endpoint including technical success rate, the venous clinical severity score (VCSS), chronic venous insufficiency questionnaire (CIVIQ-20) score and visual analogue scale (VAS) for pain...

Percutaneous catheter-based closure is increasingly utilized in premature newborns. While near-infrared spectroscopy (NIRS) has been examined for assessment of interventional closure in surgical ligation, its application in percutaneous transcatheter closure remains unexplored. This study aims to assess cerebral and renal hemodynamic changes using NIRS during percutaneous closure compared to surgical closure in preterm infants. A prospective observational study enrolled preterm infants born at 32 weeks of gestation or less and diagnosed with hsPDA between January 2020 and December 2022...

BACKGROUND: The use of left ventricular assist devices (LVADs) for patients with end-stage cardiac failure awaiting heart transplantation has become increasingly common. However, ventricular assist device-related infections remain a major problem complicating their long-term use. Retrospective review has previously shown a decrease in lifetime return to operating room (RTOR) with no change in 90-day complications when a muscle or omental flap is used for coverage after washout for infection...

OBJECTIVES: Anterior open bite can be treated non-surgically via molar intrusion using temporary skeletal devices (TAD). Clear aligner therapy (CAT) is recognized as a viable therapeutic modality for non-extraction treatment of adults with mild open bite. This study aimed to compare the treatment effect and mechanisms of open bite closure between patients treated with braces and TADs double arch intrusion and those treated with CAT. Treatment success at T3 was based on 1- positive overbite on ceph; 2- Change in the vertical dimension 3- post treatment POSI score equal to zero...

More than 1 million transcatheter-based cardiovascular procedures across the spectrum of interventional cardiology are performed annually in the United States. With the expanded indications for and increased complexities associated with these procedures, interventional cardiologists are expected to possess the requisite expertise to complete these interventions safely and effectively. While the art of vascular access and closure remains a prerequisite and critical skillset in contemporary practice, there remain significant variations in the techniques employed, resulting in the bleeding and vascular complications encountered in clinical practice...

Left atrium appendage closure is a safe and effective therapy for patients with atrial fibrillation and high thromboembolic and hemorrhagic risks. Prosthesis embolization is a potential major complication with an incidence of 0.07%. We report a case of migration of an Amplatzer Amulet (Abbott) device that was successfully retrieved in an innovative way (4).

The left atrial appendage (LAA) occluder is an important medical device for closing the LAA and preventing stroke. The device-related thrombus (DRT) prevents the implantation of the occluder in exerting the desired therapeutic effect, which is primarily caused by the delayed endothelialization of the occluder. Functional coatings are an effective strategy for accelerating the endothelialization of occluders. However, the occluder surface area is particularly large and structurally complex, and the device is subjected to a large shear friction in the sheath during implantation, which poses a significant challenge to the coating...

Background: Transcatheter closure of a patent foramen ovale (PFO) is performed in cryptogenic stroke and other conditions. Information is lacking for some devices. Methods: We aimed to evaluate the Figulla Flex II PFO Occluder (FFP) and Figulla Flex UNI Occluder (FFU) through a retrospective multi-center registry. Results : 527 patients were included. Mean age was 48.9 (±13.8) years. The procedure was under transthoracic, transesophageal or intracardiac echocardiography in 185 (35.1%), 193 (36.6%) and 149 (28...

Background: Pulmonary vein isolation is currently considered to be the gold standard for ablating paroxysmal atrial fibrillation. However, its efficacy is limited in patients with persistent atrial fibrillation. The convergent procedure has emerged as a hybrid ablation. This study aims, for the first time in the literature, to introduce a hybrid approach that includes epicardial ablation with cutting-edge robotic technology and subsequent electrophysiological study to verify and an endocardial ablation to complete the ablation lines...

STUDY OBJECTIVE: To investigate diverse hysterectomy techniques to determine their influence on patient outcomes, including pain levels, sexual function, anxiety, and quality of life. Of particular focus is the comparison between vessel sealing and traditional suturing in abdominal, vaginal, and laparoscopic hysterectomies. This study is unique in its comprehensive evaluation, considering patient satisfaction, recommendation rates, recovery times, and various other aspects. METHOD: Our prospective cohort study adhered to ethical guidelines, involving a meticulous assessment of patients, including medical history, anxiety levels, pelvic pain, sexual function, and quality of life...

INTRODUCTION: With the introduction of transcatheter aortic valve implantation (TAVI), endovascular abdominal aortic aneurysm repair (EVAR), thoracic endovascular aortic aneurysm repair (TEVAR), and frequent use of left ventricular assist devices in complicated percutaneous coronary interventions, the use of large bore arterial access has become a necessity. In the index study, we compared the percutaneous closure of large arteriotomies with open surgical (OS) closure. METHODS: It was a prospective study in which we compared the technical success and vascular complication rate associated with the use of a suture-based vascular closure device (VCD): Perclose ProGlide (PP) with that of OS closure...