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.

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.

Risk profiles and outcomes of patients receiving antibacterial cardiovascular implantable electronic device envelopes:A retrospective analysis

BACKGROUND Cardiovascular implantable electronic devices(CIEDs)are implanted in an increasing number of patients each year,which has led to an increase in the risk of CIED infection.Antibacterial CIED envelopes locally deliver antibiotics to the implant site over a short-term period and have been shown to reduce the risk of implant site infection.These envelopes are derived from either biologic or nonbiologic materials.There is a paucity of data examining patient risk profiles and outcomes from using these envelope materials in the clinical setting and comparing these results to patients receiving no envelope with their CIED implantation.AIM To evaluate risk profiles and outcomes of patients who underwent CIED procedures with an antibacterial envelope or no envelope.METHODS After obtaining Internal Review Board approval,the records of consecutive patients who underwent a CIED implantation procedure by a single physician between March 2017 and December 2019 were retrospectively collected from our hospital.A total of 248 patients within this period were identified and reviewed through 12 mo of follow up.The CIED procedures used either no envelope(n=57),a biologic envelope(CanGaroo®,Aziyo Biologics)that was pre-hydrated by the physician with vancomycin and gentamicin(n=89),or a non-biologic envelope(Tyrx^(TM),Medtronic)that was coated with a resorbable polymer containing the drug substances rifampin and minocycline by the manufacturer(n=102).Patient selection for receiving either no envelope or an envelope(and which envelope to use)was determined by the treating physician.Statistical analyses were performed between the 3 groups(CanGaroo,Tyrx,and no envelope),and also between the No Envelope and Any Envelope groups by an independent,experienced biostatistician.RESULTS On average,patients who received any envelope(biologic or non-biologic)were younger(70.7±14.0 vs 74.9±10.6,P=0.017),had a greater number of infection risk factors(81.2%vs 49.1%,P<0.001),received more high-powered devices(37.2%vs 5.8%,P=0.004),and were undergoing more reoperative procedures(47.1%vs 0.0%,P<0.001)than patients who received no envelope.Between the two envelopes,biologic envelopes tended to be used more often in higher risk patients(84.3%vs 78.4%)and reoperative procedures(62.9%vs 33.3%)than non-biologic envelopes.The rate of CIED implant site pocket infection was low(any envelope 0.5%vs no envelope 0.0%)and was statistically equivalent between the two envelope groups.Other reported adverse events(lead dislodgement,lead or pocket revision,device migration or erosion,twiddler’s syndrome,and erythema/fever)were low and statistically equivalent between groups(biologic 2.2%,non-biologic 3.9%,no envelope 1.8%).CONCLUSION CIED infection rates for biologic and non-biologic antibacterial envelopes are similar.Antibacterial envelopes may benefit patients who are higher risk for infection,however additional studies are warranted to confirm this.

Optimized Axillary Vein Technique versus Subclavian Vein Technique in Cardiovascular Implantable Electronic Device Implantation： A Randomized Controlled Study

Background：The conventional venous access for cardiovascular implantable electronic device （CIED） is the subclavian vein,which is often accompanied by high complication rate.The aim of this study was to assess the efficacy and safety of optimized axillary vein technique.Methods：A total of 247 patients undergoing CIED implantation were included and assigned to the axillary vein group or the subclavian vein group randomly.Success rate of puncture and complications in the perioperative period and follow-ups were recorded.Results：The overall success rate （95.7% vs.96.0%） and one-time success rate （68.4% vs.66.1%） of punctures were similar between the two groups.In the subclavian vein group,pneumothorax occurred in three patients.The subclavian gaps of three patients were too tight to allow operation of the electrode lead.In contrast,there were no puncture-associated complications in the axillary vein group.In the patient follow-ups,two patients in the subclavian vein group had subclavian crush syndrome and both of them received lead replacement.The incidence of complications during the perioperative period and follow-ups of the axillary vein group and the subclavian vein group was 1.6% （2/125） and 8.2% （10/122）,respectively （χ^2=5.813,P =0.016）.Conclusion：Optimized axillary vein technique may be superior to the conventional subclavian vein technique for CIED lead placement.

Effect of fluoroscopy frame rate on radiation exposure and in-hospital outcomes in cardiovascular implantable electronic device implantation procedures

Objective:To assess the radiation exposure in cardiovascular implantable electronic device(CIED)implantation procedures,the effect of fluoroscopy frame rate on various radiation exposure indices,and in-hospital outcomes.Methods:Data of CIED implantation procedures from September 2015 to December 2019 of all the CIED implantation procedures performed at our institute were retrospectively analyzed.The procedural data were divided into two groups:a)pre-group:procedures that were performed under fluoroscopy frame rate of 7.5 frames per second(fps);b)post-group:procedures that were performed under fluoroscopy frame rate of 3.75 fps.We compared procedure time,fluoroscopy time,Kerma air product,effective dose,and in-hospital outcomes between the two groups.Results:A total of 2,225 procedures were included in the analysis with mean age of(62±15)years.The procedures consisted of the implantation of single-chamber(n=1,436),double chamber(n=656),and biventricular devices(n=133).Procedure time and radiation indices showed a significant reduction over the study period(P<0.001).Reduction in the fluoroscopy frame rate was associated with a significant reduction in radiation exposure indices(P<0.001).In-hospital outcomes did not differ between the two groups.Conclusions:Reduction in the fluoroscopy frame rate from 7.5 to 3.75 fps significantly decreased the radiation exposure in CIED implantation procedures.A framerate lower than 3.75 fps should be the default setting during such procedures.

Remote monitoring of implantable cardioverters defibrillators:a comparison of acceptance between octogenarians and younger patients

Background Remote monitoring(RM)is increasingly employed for all types of cardiac implantable devices(CIED).However,there are only limited data on the acceptance of RM by the elderly.The aim of our study was to ascertain how octogenarians assess RM technologies compared to younger,presumably technically more literate patients,and what concerns or technical problems the system presents to both groups of patients.Methods The trial was designed as a descriptive,register-based single-center study.The study population consisted of all consecutive patients≥80 years of age(group A,n=94)and all consecutive patients aged≤40 years(group B,n=71),who had undergone implantation of an implantable cardioverter-defibrillator(ICD)between the years of 2009 and 2018 and were using a Home Monitoring?(HM,Biotronik,Berlin,Germany)system.All patients fulfilling entry criteria were approached with a request to participate in the survey.Results A total of 85(90.4%)and 65(91.5%)valid surveys were obtained for groups A and B,respectively.Ninety-two percent of patients in both groups(P=0.903)were satisfied with the limited number of planned ambulatory follow-ups(i.e.,once a year).All patients in both groups(100%)reported that they were satisfied with the HM system,and 97%and 94%of patients in Groups A and B,respectively,ranked it highly beneficial(P=0.68).A significant proportion of patients in both groups were completely unaware of any health-related benefits associated with the use of the HM system(42%in Group A vs.49%in Group B,P=0.4).Among the most frequently reported personal benefits of HM were a sense of safety and security and savings on travel expenses and time.5%and 9%of patients in Groups A and B,respectively,reported that usage of HM caused them some degree of psychological stress(P=0.27).Nearly all patients in both groups reported receiving information on HM from their doctor after ICD implantation.None of Group A reported receiving information from a nurse either before or after ICD implantation,while 14%of Group B patients reported receiving information from a nurse after,but not before ICD implantation.Seven and 51%(P<0.0001)of patients in Group A and B,respectively,sought additional information about HM post-discharge.Conclusions The HM system received good marks and was much appreciated,even in patients over 80 years of age.The level of acceptance and potential psychological stress resulting from RM technology appears to be about the same in older patients as in younger patients.The majority of octogenarians either did not fully understand the clinical benefits of the system or mistakenly thought that the HM system was a substitute for emergency 24-h surveillance.These results highlight the need for better patient education relative to RM technology,with one option being to delegate more of this educational process to specially trained nurses.

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]).

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.

Materials and applications of bioresorbable electronics

Bioresorbable electronics is a new type of electronics technology that can potentially lead to biodegradable and dissolvable electronic devices to replace current built-to-last circuits predominantly used in implantable devices and consumer electronics. Such devices dissolve in an aqueous environment in time periods from seconds to months, and generate biological safe products. This paper reviews materials, fabrication techniques, and applications of bioresorbable electronics, and aims to inspire more revolutionary bioresorbable systems that can generate broader social and economic impact. Existing challenges and potential solutions in developing bioresorbable electronics have also been presented to arouse more joint research efforts in this field to build systematic technology framework.

A robust and transparent nanosilica-filled silicone rubber coating with synergistically enhanced mechanical properties and barrier performance

Implantable electronic devices(IEDs)are widely used by human beings to achieve medical treatment and diagnosis nowadays.However,ideal encapsulation of IEDs is still far from perfect as full prevention of body fluid diffusion into the coating remains unsolved.Herein,we develop a high-performance composite coating for IED encapsulation by introducing SiO_(2) nanoparticles into silicone rubber,which synergistically enhances mechanical properties and improves barrier performance.By fabricating composite coatings with different nanosilica contents,3%nanosilica is proved to be an optimal additive content with an excellent combination of improved fracture strength(from 2.5 MPa to 4.5 MPa),increased coating resistance(from 10^(4) to 10^(9) cm^(2))and ideal coating uniformity.Mechanical and electrochemical characterizations subsequently confirm substantially enhanced mechanical properties and barrier performance of the composite coating,which effectively resist crack propagation and impede penetrations of water and chloride ions through the coating.Theoretical calculations further uncover that modified SiO_(2) particles with enriched methyl groups endow a strong bridging effect to interact with silicone rubber monomer,which,together with anti-agglomeration property of methyl groups,contributes to a pronounced improvement in mechanical performance of nanosilica-filled silicone rubber.Benefitting from the enhanced mechanical and barrier properties,the as-fabricated nanosilica-filled silicone rubber demonstrates superior protection for the encapsulated circuits with a significantly improved lifetime(709.1 h)compared to that of circuits coated by pure silicone rubber(472.8 h)and bare circuit boards(1 h),which offers great values for packaging material design in future IED encapsulation.