A study to assess a novel automated electrocardiogram technology in screening for atrial fibrillation.

INTRODUCTION: Atrial fibrillation is often asymptomatic and un-diagnosed in the community resulting in an increased risk of heart failure and stroke to those patients. We evaluated the effectiveness, tolerability, and accuracy of a novel six-channel electrocardiogram digital-health screening device, the RhythmPad, for the detection of atrial fibrillation. METHODS: Seven hundred and fifty-two participants attending the cardiology department were recruited. Two recordings were taken-a six-lead electrocardiogram using the RhythmPad device and a standard 12-lead electrocardiogram. Recorded traces were analyzed by two blinded cardiologists. The computer-generated automated diagnostic reports from both systems were also compared. Post-participation feedback was obtained from study participants using a three-part questionnaire. RESULTS: The sensitivity of the six-lead electrocardiogram compared to the 12-lead electrocardiogram, analyzed by two blinded cardiologists, for the detection of normal sinus rhythm was 95.9%, with a specificity of 97.2%. The sensitivity for the detection of atrial fibrillation using the six-lead ECG was 93.4%, with specificity 96.8%. The six-lead automated diagnostic report had a sensitivity and specificity of 97.5% and 98.6%, respectively, for correctly diagnosing normal sinus rhythm. For the correct diagnosis of atrial fibrillation, the six-lead automated diagnostic report had a sensitivity and specificity of 95.4% and 98.8%, respectively. A total of 95.4% of participants found RhythmPad to be comfortable, with only 0.5% preferring the 12-lead ECG device in comparison to six-lead ECG acquisitions. CONCLUSION: The RhythmPad digital health device and its automated diagnostic report were highly accurate in detecting atrial fibrillation when compared to a standard 12-lead electrocardiogram.

Usefulness of a 4-Grade Novel Mouthpiece Device for Increased Mouth Pressure Reproducing Artificial Difficulty in Breathing.

OBJECTIVE: The use of a novel 4-grade mouthpiece device to reproduce difficulty in breathing was assessed in healthy individuals. METHODS: A double-blind, randomized, crossover-controlled trial was conducted to investigate the efficacy and safety of the device with increasing mouth pressure. The modified Borg (mBorg) scale values, respiratory system resistance at 5 Hz (R5), and forced expiratory volume in one second (FEV1) were assessed while using the device. MATERIALS: The four grades of breathing difficulty device were tested in 32 healthy participants. RESULTS: The 4-grade device linearly worsened the mBorg scale with increasing mouth pressure. The mean R5 (± standard deviation [SD]) with grade I, II, III, and IV devices were 5.6 ± 0.1, 10.3 ± 0.3, 21.5 ± 0.7, and 54.8 ± 2.0 kPa/L/s, respectively. The mean %FEV1 predicted (± SD) were 83.6 ± 15.9% with grade I, 55.3 ± 11.8% with grade II, 32.0 ± 6.1% with grade III, and 15.3 ± 3.2% with the grade IV device. The mBorg scale was positively correlated with R5 (r = 0.79, p < 0.0001) and negatively with %FEV1 predicted (r = -0.81, p < 0.0001). No severe adverse events were reported during the trial. CONCLUSION: We demonstrated that the novel device could effectively reproduce the semi-quantitative artificial difficulty in breathing safely and easily in healthy individuals. These devices could be helpful to understand the mechanisms of difficulty in breathing.

An Up-to-Date Narrative Review on Congenital Heart Disease Percutaneous Treatment in Children Using Contemporary Devices.

BACKGROUND: Congenital heart pathology has a significant burden regarding morbidity and mortality in the pediatric population. Several transcatheter interventions and devices have been designed as an alternative to surgical repair. Percutaneous interventions have been proven to yield good results in most cases but with less stress and trauma than that attributed to surgical treatment, especially in frail pediatric patients. We aimed to review the literature and to investigate the feasibility and efficacy of transcatheter interventions and implantable devices for congenital heart disease management in children. METHODS: We performed a search in Scopus and MEDLINE databases using prespecified keywords to retrieve clinical studies published between 2000 and 2021. RESULTS: This article provides an up-to-date review regarding the applicability of interventional techniques in simple inter-atrial or inter-ventricular defects, and in challenging congenital defects, such as hypoplastic left heart syndrome, tetralogy of Fallot, or coronary artery fistula. Furthermore, we reviewed recent indications for defibrillator and cardiac resynchronization therapy, and new and promising devices currently being tested. CONCLUSION: Transcatheter treatment represents a feasible and efficient alternative to surgical repair of congenital heart defects. Novel devices could extend the indications and possibilities of percutaneous interventions in pediatric patients with congenital heart diseases.

Novel Therapeutic Devices in Heart Failure.

Heart failure (HF) constitutes a significant clinical problem and is associated with a sizeable burden for the healthcare system. Numerous novel techniques, including device interventions, are investigated to improve clinical outcome. A review of the most notable currently studied devices targeting pathophysiological processes in HF was performed. Interventions regarding autonomic nervous system imbalance, i.e., baroreflex activation therapy; vagus, splanchnic and cardiopulmonary nerves modulation; respiratory disturbances, i.e., phrenic nerve stimulation and synchronized diaphragmatic therapy; decongestion management, i.e., the Reprieve system, transcatheter renal venous decongestion system, Doraya, preCardia, WhiteSwell and Aquapass, are presented. Each segment is divided into subsections: potential pathophysiological target, existing evidence and weaknesses or unexplained issues. Novel therapeutic devices represent great potential in HF therapy management; however, further evidence is necessary to fully evaluate their utility.

A Review of Cardiac Implantable Electronic Device Infections for the Practicing Electrophysiologist.

Cardiovascular implantable electronic device (CIED) infections are morbid, costly, and difficult to manage. This review explores the pathophysiology, diagnosis, and management of CIED infections. Diagnostic accuracy has been improved through increased awareness and improved imaging strategies. Pocket or bloodstream infection with virulent organisms often requires complete system extraction. Emerging prophylactic interventions and novel devices have expanded preventative strategies and options for re-implantation. A clear and nuanced understanding of CIED infection is important to the practicing electrophysiologist.

Bioengineered percutaneous heart valves for transcatheter aortic valve replacement: a comparative evaluation of decellularised bovine and porcine pericardia.

Glutaraldehyde-treated, surgical bioprosthetic heart valves undergo structural degeneration within 10-15 years of implantation. Analogous preliminary results were disclosed for percutaneous heart valves (PHVs) realized with similarly-treated tissues. To improve long-term performance, decellularised scaffolds can be proposed as alternative fabricating biomaterials. The aim of this study was to evaluate whether bovine and porcine decellularised pericardia could be utilised to manufacture bioengineered percutaneous heart valves (bioPHVs) with adequate hydrodynamic performance and leaflet resistance to crimping damage. BioPHVs were fabricated by mounting acellular pericardia onto commercial stents. Independently from the pericardial species used for valve fabrication, bioPHVs satisfied the minimum hydrodynamic performance criteria set by ISO 5840-3 standards and were able to withstand a large spectrum of cardiac output conditions, also during extreme backpressure, without severe regurgitation, especially in the case of the porcine group. No macroscopic or microscopic leaflet damage was detected following bioPHV crimping. Bovine and porcine decellularized pericardia are both suitable alternatives to glutaraldehyde-treated tissues. Between the two types of pericardial species tested, the porcine tissue scaffold might be preferable to fabricate advanced PHV replacements for long-term performance. CONDENSED ABSTRACT: Current percutaneous heart valve replacements are formulated with glutaraldehyde-treated animal tissues, prone to structural degeneration. In order to improve long-term performance, bovine and porcine decellularised pericardia were utilised to manufacture bioengineered replacements, which demonstrated adequate hydrodynamic behaviour and resistance to crimping without leaflet architectural alteration.

Cervical Total Disc Replacement: Novel Devices.

This article reviews the available literature for novel cervical total disc replacement devices, including ones which are available inside and outside of the United States. It includes biomechanical consideration as well as design characteristics and clinical data when available.

Image-guided surgery and novel intraoperative devices for enhanced visualisation in general and paediatric surgery: a review.

Fluorescence guided surgery, augmented reality, and intra-operative imaging devices are rapidly pervading the field of surgical interventions, equipping the surgeon with powerful tools capable of enhancing the surgical visualisation of anatomical normal and pathological structures. There is a wide range of possibilities in the adult population to use these novel technologies and devices in the guidance for surgical procedures and minimally invasive surgeries. Their applications and their use have also been increasingly growing in the field of paediatric surgery, where the detailed visualisation of small anatomical structures could reduce procedure time, minimising surgical complications and ultimately improve the outcome of surgery. This review aims to illustrate the mechanisms underlying these innovations and their main applications in the clinical setting.

Procedural and Short-Term Results With the New Watchman FLX Left Atrial Appendage Occlusion Device.

OBJECTIVES: This study sought to report early experience with the new-generation Watchman FLX device (Boston Scientific, Marlborough, Massachusetts). BACKGROUND: The new-generation Watchman FLX features a reduced height, improved anchoring and fabric coverage, and a closed distal end. These design modifications aim to simplify implantation, allow full recapture and repositioning, and reduce peridevice leak and device-related thrombosis. METHODS: A total of 165 patients undergoing left atrial appendage (LAA) occlusion (LAAO) with Watchman FLX were enrolled in a prospective, multicenter registry at 12 centers participating in the European limited market release program. RESULTS: Mean age was 75.4 ± 8.9 years, and CHA2DS2-VASc score 4.4 ± 1.4. A total of 128 patients (77.6%) had a history of major bleeding, including previous intracranial hemorrhage in 55 cases (33.3%). LAA landing zone minimal and maximal mean diameters were 19.1 ± 3.6 mm and 22.3 ± 3.7 mm, and 24.2% of LAA were considered complex by dimensions. Technical success was achieved in all patients. Successful implantation at first attempt was achieved in 129 cases (78.2%), and a second device was required in 6 cases (3.6%). Procedure-related complications occurred in 3 patients (1.8%): 2 access-related (1.2%) and 1 pericardial effusion (0.6%). No peri-procedural strokes, deaths, or device embolizations occurred. Forty-nine patients (29.7%) were discharged with single antiplatelet therapy, 105 (63.6%) on dual antiplatelet, and 11 (6.7%) on anticoagulation. Imaging follow-up displayed just 1 peridevice leak ≥5 mm and 7 cases of device-related thrombosis (4.7%). During a median follow-up of 55 days (interquartile range: 45 to 148 days), there were 6 hemorrhagic complications (4.8%), 1 patient (0.8%) had an ischemic stroke, and 1 (0.8%) died. No late device embolizations occurred. CONCLUSIONS: LAAO with the Watchman FLX is safe and effective in a wide range of LAA morphologies, with a low procedural complication rate, high degree of LAA sealing, and favorable short-term efficacy.

Novel materials and devices in the transcatheter management of congenital heart diseases--the future comes slowly (part 1).

Management of congenital defects of the heart and great vessels constitutes the largest part of paediatric cardiology practice. Most of these defects require interventions, either corrective or palliative, to guarantee patient survival, symptom relief and/or better quality of life. Interventions can be performed either surgically or transcatheter percutaneously. The surgical repairs are invasive, with long-term results often being suboptimal for complex lesions and after the use of grafts, especially in small patients. Nowadays, various transcatheter devices allow much less invasive percutaneous management in some carefully selected patients with congenital heart disease. However, the currently available materials and devices are only suitable for a small proportion of children, while the majority of young patients with cardiac defects still need surgery, as no transcatheter alternatives exist. There are, however, numerous new biomaterials, devices and technologies that have the potential to expand the transcatheter approach to a much broader spectrum of congenital cardiovascular lesions and conditions. In this three-part review, we describe new advances in transcatheter devices and materials, which promise to extend the application of the percutaneous approach to younger and more complex patient groups with congenital heart disease. The first part focuses on new possibilities for the transcatheter treatment of vascular stenoses in growing patients and the closure of intracardiac defects.

Novel materials and devices in the transcatheter creation of vascular anastomosis--the future comes slowly (part 2).

Completion of the total cavopulmonary connection and creation of the majority of vascular anastomoses are currently usually performed surgically. The major disadvantage of the surgical approach, however, is its invasiveness, as patients undergoing cardiac surgery generally need sternotomy and cardiopulmonary bypass - often with cardiac arrest - commonly resulting in a prolonged and complicated postoperative intensive care period. Transcatheter procedures, in contrast, have a lower risk of complications, shorter intensive care and total hospital stays, and do not need a cardiopulmonary bypass or sternotomy. The second part of our review focuses on new advances in transcatheter technology, which will allow safe and effective percutaneous management of patients requiring the creation of an intervascular anastomosis and completion of the total cavopulmonary connection. It will create a therapeutic alternative able to reduce the surgical burden on this group of patients.