Cardiac implantable therapeutic medical devices:A narrative review

Heart diseases are common life-threatening acute diseases.They are leading causes of mortality worldwide,especially significant in developed countries.Other than medications for therapies and prophylaxis,special treatment considerations with implantable cardiac devices are important to reduce mortality and medical disability.This paper aims to review indications,contraindications,efficacy,complications,and generic considerations of several commonly implanted cardiac devices including pacemakers,cardiac resynchronization devices,implantable cardiac defibrillators,left atrial appendage occlusion watchman devices,and ventricular assist devices.As various implantable therapeutic cardiac devices are sometimes carried in the bodies of patients with cardiac disease,practitioners of various specialties should be familiar with different cardiac devices on the management of different cardiac conditions while providing holistic care.

The gender difference of utilization of cardiac implantable electronic device in China： data from Arrhythmia Interventional Therapy Data Registry

Background Cardiac implantable electronic devices （CIEDs） greatly improve survival and life quality of patients. However, there are gender differences regarding both the utilization and benefit of these devices. In this prospective CIED registry, we aim to appraise the gender differences in CIED utilization in China. Methods Twenty centers from 14 provinces in China were included in our registry study. All patients who underwent a CIED implantation in these twenty centers between Jan 2015 and Dec 2016 were included. Results A total of 8570 patients were enrolled in the baseline cohort, including 7203 pacemaker, 664 implantable cardiac defibrillators （ICD） implants and 703 cardiac resynchronization therapy device （CRT/D）. Totally, 4117 （48.0%） CIED patients were female, and more than 59% pacemaker patients were female, but women account only one third of ICD or CRT/D implantation in this registry. There were significant differences between genders at pacemaker and ICD indications. Female was more likely received a pacemaker due to sick sinus syndrome （SSS） （63.9% vs. 51.0%, P 〈 0.001）. Female patients receiving an ICD were more likely due to cardiac ion channel disease （29.2% vs. 4.2%, P 〈 0.001）. The percentage of utilization of dual-chamber pacemaker in female patients was significantly higher than male （85.3% vs. 81.1%, P 〈 0.001）. But male patients were more likely received a cardiac resynchronization therapy devices with defibrillator than female （56.5% vs. 41.9%, P = 0.001）. In pacemaker patient, male was more likely to have structure heart disease （31.3% vs. 28.0%, P = 0.002）. In ICD patient, male patients were more likely to have ischemic heart disease （48.2% vs. 29.2%, P 〈 0.001）. The mean age of women at the time of CRT/D implantation was older than men （P = 0.014）. Nonischemic cardiomyopathy （70.9%） was the most common etiology in the patients who underwent the treat？ment of CRT/D, no matter male or female. Conclusions In real-world setting, female do have different epidemiology, pathophysiology and clinical presentation of many cardiac rhythm disorders when compared with male, and all these factors may affect the utilization of CIED implantation. But it also possibility that cultural and socioeconomic features may play a role in this apparent discrimination.

Geriatric issues in patients with or being considered for implanted cardiac rhythm devices: a case-based review

1 Introduction Virtually all cardiovascular diseases including arrhythmias,valve disease,coronary artery disease and heart failure(HF)are increasingly common with advancing age.^([1])Age and disease-related changes in the heart including fibrosis in the atrial and ventricular myocardium and conduction system,scar tissue from myocardial infarction or other cardiomyopathic processes,increased inflammatory cytokines and changes to ion channels are just some of the factors that predispose older adults to arrhythmias.^([2]).

Effects of medically generated electromagnetic interference from medical devices on cardiac implantable electronic devices: A review

As cardiac implantable electronic devices(CIED)become more prevalent,it is important to acknowledge potential electromagnetic interference(EMI)from other sources,such as internal and external electronic devices and procedures and its effect on these devices.EMI from other sources can potentially inhibit pacing and trigger shocks in permanent pacemakers(PPM)and implantable cardioverter defibrillators(ICD),respectively.This review analyzes potential EMI amongst CIED and left ventricular assist device,deep brain stimulators,spinal cord stimulators,transcutaneous electrical nerve stimulators,and throughout an array of procedures,such as endoscopy,bronchoscopy,and procedures involving electrocautery.Although there is evidence to support EMI from internal and external devices and during procedures,there is a lack of large multicenter studies,and,as a result,current management guidelines are based primarily on expert opinion and anecdotal experience.We aim to provide a general overview of PPM/ICD function,review documented EMI effect on these devices,and acknowledge current management of CIED interference.

Feasibility of a Chronic Foreign Body Infection Model Studying the Influence of TiO2 Nanotube Layers on Bacterial Contamination

Bacterial infections on the surface of medical devices are a significant problem in therapeutic approach, especially when implants are used in the living. In cardiology, pacemaker generator pocket surfaces, made in titanium alloy can be colonized by pathogen microorganism. This contamination represents a major risk of sepsis, endocarditis and localized infections for patients. A way to limit this bacterial contamination is to modify the surface topography using nano-structuration process of the titanium alloy surface of the implanted devices. The aim of this study is to evaluate the influence of TiO2 nanotube layers on bacterial infection in the living, considering the feasibility of an animal model of chronic foreign body infection. TiO2 nanotube layers prepared by electrochemical anodization of Ti foil in 0.4 wt% hydrofluoric acid solution were implanted subcutaneously in Wistar rats. Three weeks after implantation, TiO2 implants were contaminated by a Staphylococcus epidermilis strain using two different concentrations at 106 and 108 colony forming unit (CFU) in order to induce a sufficient infection level and to avoid unwanted over infection consequences on rats health during the experiments. After 28 days in the living, 75% of nanotube layers initially submitted to the 108 CFU inoculum were contaminated while only 25% nanotube layers initially submitted to the 106 CFU inoculum remained infected. This significant result underlines the influence of TiO2 nanotube layers in decreasing the infection level. Our in vitro experiments showed that the synthesized TiO2 nanotubes indeed decreased the Staphylococcus epidermilis adhesion compared to unanodized Ti foil.

Re-evaluation of Transvenous Lead Extraction with Modified Standard Technique: A Prospective Study in 229 Patients

As new-type powered sheaths are expensive and unavailable, the standard lead extraction techniques remain the mainstay in clinical applications in many countries. The purpose of this study was to re-evaluate the clinical application of the standard lead extraction techniques and equipment, and make some procedural modifications and innovations. In our center, between January 2006 and May 2012, 229 patients （median, 66 years） who underwent lead extraction due to infection and lead malfunc- tion were registered and followed up prospectively with respect to clinical features, reasons for lead ex- traction, technical characteristics, and clinical prognosis. A total of 440 leads had to be extracted trans- venously by using special tools from 229 patients （male, 72.1%）. Vegetations 〉1 cm were detected in six patients. Locking Stylets were applied for 398 （90.5%） leads. Telescoping dilator polypropylene sheaths and counter traction technique were used for 202 （45.9%） leads due to lead adhesion, and the mean im- plant duration of the 202 leads was longer than the other 238 leads （48.9±22.6 vs. 26.6±17.8 months; P 〈0.01）. In addition, modified isolation and snare techniques were used for 56 leads （12.7%）. Minor and major procedure-related complications occurred in three （1.3%） and four （1.7%） cases respectively, in- cluding one death （0.4%）. Severe lead residue occurred in one case. Complete procedural success rate was 96.1% （423/440）, and clinical success rate was 98.9% （435/440）. The median follow-up period was 18 （1-76） months. No infection- and procedure-related death occurred in our series. Our data demon- strated that high clinical success rate of transvenous lead extraction can be guaranteed by making full use of the standard lead extraction techniques and equipment with individualized modifications.

CIED implantation in elderly patients： a single-center experience

Thanks to the development of new medical technologies and improvement in medical care the last decades are characterized by the growth of elderly＇s number. The median age of the world＇s population is increasing because of a decline in birth rates and a 20-year increase in the average life span during the second half of the 20th century.

Bioinspired approaches for medical devices

Advances in medical devices have revolutionized the treatment of human diseases,such as stents in occluded coronary artery,left ventricular assist devices in heart failure,pacemakers in arrhythmias,etc.Despite their significance,the development of devices for reducing and avoiding the thrombosis formation,obtaining excellent mechanical performance,and achieving stable electronic physiology remains challenging and unresolved.Fortunately,nature serves as a good resource of inspirations,and brings us endless bioinspired physicochemical ideas to better the development of novel artificial materials and devices that enable us to potentially overcome the unresolved obstacles.Bioinspired approaches,in particularly,owe much of their current development in biology,chemistry,materials science,medicine and engineering to the design and fabrication of advanced devices.The application of bioinspired devices is a burgeoning area in these fields of research.In this perspective,we would take the cardiovascular device as one example to show how these bioinspired approaches could be used to build novel,advanced biomedical devices with precisely controlled functions.Here,bioinspired approaches are utilized to solve issues like thrombogenic,mechanical and electronic physiology problems in medical devices.Moreover,there is an outlook for future challenges in the development of bioinspired medical devices.

Reduction of atrial fibrillation in remotely monitored pacemaker patients： results from a Chinese multicentre registry

Background Many recipients of implantable cardiac electronic devices have atrial fibrillation （AF） occurrences after device implantation, even if there is no previous history of AF, and some of the episodes are asymptomatic. The purpose of this study was to evaluate trends in AF burden following early AF detection in patients treated with pacemakers equipped with automatic, daily Home Monitoring function. Methods Between February 2009 and December 2010, the registry recruited 701 pacemaker patients （628 dual-chamber, 73 biventricular devices） at 97 clinical centers in China. Daily Home Monitoring data transmissions were analyzed to screen for the AF burden. In-office follow-ups were scheduled for 3 and 6 months after implantation. Upon first AF （i.e., mode-switch） detection in a patient, screening olAF burden by Home Monitoring was extended for the next 180 days. Results At least one episode of AF was observed in 22.9% of patients with dual-chamber pacemakers and in 28.8% of patients with biventricular pacemakers. The first AF detection in a patient occurred, on average, about 2 months before scheduled follow-up visits. In both pacemaker groups, mean AF burden decreased significantly （P〈0.05） over 180 days following first AF detection： from 12.0% to 2.5% in dual-chamber and from 12.2% to 0.5% in biventricular pacemaker recipients. The number of patients with an AF burden 〉10% per month was significantly reduced over 6 months of implantation in both dual chamber （38 patients in the first month vs. 21 patients in month 6, P〈0.05） and biventricular （7 patients in the first month vs. 0 patient in months 4-6, P〈0.05） pacemaker recipients. Conclusions Automatic, daily Home Monitoring of patients treated with cardiac pacemakers allows early detection of AF, and there is a gradual and significant decrease in AF burden.