RESUMEN

Background: A novel non-contact system for remote parameter testing and reprogramming offers an alternative method for assessing device parameters during cardiac implantable electronic devices (CIEDs) implantation without the need for physical contact with the manufacturer's clinical service technician. The safety and feasibility of using this system in CIEDs implantation procedures remains to be determined. Objective: Evaluate the safety and feasibility of remote parameter testing in CIEDs implantation procedures. Methods: A single center, randomized, open-label, non-inferiority trial (ChiCTR2200057587) was conducted to compare the two approaches for interrogating CIEDs during implantation procedures: routine interrogation performed by on-site technicians or remote interrogation performed by technicians using the 5G-Cloud Technology Platform. Patients aged ≥18 years and elected to receive CIEDs were eligible for inclusion. The primary endpoint was the completion rate of the parameter test. Safety and efficiency were evaluated in all randomly assigned participants. Results: A total of 480 patients were finally enrolled and were randomly assigned to routine group (n = 240) or remote group (n = 240). The primary endpoint was achieved by 100% in both groups (P = 0.0060 for noninferiority). The parameters of sensing, threshold, and impedance regarding the right atrium, right ventricle, and left ventricle had no statistical significance between the two groups (P > 0.05). Procedure time, parameter testing time, and both duration and dose of x-ray irradiation were not significantly different between the two groups (P > 0.05). Shut-open door frequency was significantly higher in the routine group than the remote group [6.00 (4.00, 8.00) vs. 0, P < 0.0001]. Notably, no clinical or technical complications were observed in the remote group. Conclusions: Remote parameter testing is safe and feasible across various devices implantation procedures. The utilization of remote parameter testing and reprogramming could represent an innovative approach to improve healthcare accessibility and unlock the full potential of secondary centers in managing CIEDs. The Registration Identification: ChiCTR2200057587.

RESUMEN

The purpose of the study is to develop new proposals for improving criminal procedural legislation in the field of conducting remote investigative actions with disabled persons, taking into account their physiological and functional characteristics. Research material and methods: This study is based on an analysis of the norms regarding the criminal procedural legislation of the Republic of Kazakhstan and a number of foreign states that regulate the procedure for conducting remote investigative actions - as well as scientific publications on the research topic in the field of psychology and medicine. An integrated approach involves considering the studied phenomena of communication during an investigative action as a set of interconnected and interdependent elements, i.e., consideration of the issue from the medical, psychological and legal points of view. Situational and systemic types of analysis, complex sociological analysis, diagnostics and forecasting investigative situation were also used. Methods of analysis and synthesis, induction, deduction, methods of qualitative and quantitative analysis were employed to clarify the legal essence of the studied phenomenon. Findings: practical recommendations aimed at improving and developing the performance of remote investigative actions involving persons with disabilities (further ­ FWDs) y creating optimal conditions for the transfer of verbal, medical, and psychological information, as well as technical and forensic support for conducting RIAs. The following conclusions were made: in order to improve the current legislation, it is advisable to consider the issue of developing and including a special norm in the legislation, taking into account the characteristics of the communicative competencies of persons with disabilities. This norm regulates the procedure for conducting investigative actions involving the mute, deaf, blind and other persons with disabilities.

El objetivo del estudio es elaborar nuevas propuestas de mejora de la legislación procesal penal en el ámbito de la realización de actuaciones de investigación a distancia con personas con discapacidad, teniendo en cuenta sus características fisiológicas y funcionales. Material y métodos de investigación: Este estudio se basa en un análisis de las normas relativas a la legislación procesal penal de la República de Kazajstán y de una serie de Estados extranjeros que regulan el procedimiento para llevar a cabo acciones de investigación a distancia -, así como publicaciones científicas sobre el tema de investigación en el campo de la psicología y la medicina. Un enfoque integrado implica considerar los fenómenos estudiados de comunicación durante una acción de investigación como un conjunto de elementos interconectados e interdependientes, es decir, considerar la cuestión desde los puntos de vista médico, psicológico y jurídico. También se utilizaron los tipos de análisis situacional y sistémico, el análisis sociológico complejo, el diagnóstico y la previsión de la situación de investigación. Se emplearon métodos de análisis y síntesis, inducción, deducción, métodos de análisis cualitativo y cuantitativo para aclarar la esencia jurídica del fenómeno estudiado. Conclusiones: recomendaciones prácticas destinadas a mejorar y desarrollar la realización de acciones de investigación a distancia en las que participen personas con discapacidad (en adelante - RIA) y crear condiciones óptimas para la transferencia de información verbal, médica y psicológica, así como apoyo técnico y forense para la realización de las RIA. Se llegó a las siguientes conclusiones:con el fin de mejorar la legislación actual, es aconsejable considerar la cuestión de desarrollar e incluir una norma especial en la legislación, teniendo en cuenta las características de las competencias comunicativas de las personas con discapacidad. Esta norma regula el procedimiento para llevar a cabo acciones de investigación en las que estén implicadas personas mudas, sordas, ciegas y otras personas con discapacidad.

O objetivo do estudo é desenvolver novas propostas para aprimorar a legislação processual penal no campo da realização de ações investigativas remotas com pessoas com deficiência, levando em conta suas características fisiológicas e funcionais. Material e métodos de pesquisa: Este estudo baseia-se em uma análise das normas relativas à legislação processual penal da República do Cazaquistão e de vários países estrangeiros que regulamentam o procedimento para a realização de ações investigativas remotas, bem como em publicações científicas sobre o tópico de pesquisa no campo da psicologia e da medicina. Uma abordagem integrada envolve a consideração dos fenômenos estudados de comunicação durante uma ação investigativa como um conjunto de elementos interconectados e interdependentes, ou seja, a consideração da questão dos pontos de vista médico, psicológico e jurídico. Também foram usados tipos de análise situacional e sistêmica, análise sociológica complexa, diagnóstico e previsão da situação investigativa. Métodos de análise e síntese, indução, dedução, métodos de análise qualitativa e quantitativa foram empregados para esclarecer a essência legal do fenômeno estudado. Resultados: recomendações práticas com o objetivo de aprimorar e desenvolver o desempenho de ações investigativas remotas envolvendo pessoas com deficiência (mais adiante - FWDs), criando condições ideais para a transferência de informações verbais, médicas e psicológicas, bem como suporte técnico e forense para a realização de RIAs. Foram feitas as seguintes conclusões: para aprimorar a legislação atual, é aconselhável considerar a questão do desenvolvimento e da inclusão de uma norma especial na legislação, levando em conta as características das competências comunicativas das pessoas com deficiência. Essa norma regulamenta o procedimento para conduzir ações investigativas envolvendo pessoas mudas, surdas, cegas e outras pessoas com deficiência.

Asunto(s)

RESUMEN

Remote control (RC) of cardiac implantable electronic devices (CIEDs) has been tested as safe and effective in the magnetic resonance imaging space. We sought to evaluate RC applications of patients at home. RC of cardiac devices in patients' homes is feasible, safe, and effective, with consistent patient satisfaction. Patients with CIEDs using the CareLink™ network (Medtronic, Minneapolis, MN, USA) participated in a pair of home RC sessions. A technician visited the patient's house and set up a telehealth tablet and a programmer, which included inputting a session key enabling programmer access via a third-party host. The investigator video-conferenced with the patient and remotely controlled the programmer for device testing and data assessment, using a cellular hotspot for Internet connection. Reprogramming was performed as necessary. In all cases, an RC session legend was programmed in the device information field as a control. The patients then completed an experience questionnaire. One hundred fifty patients (99 pacemakers and 51 implantable cardioverter-defibrillators) completed 2 RC sessions, for 300 RC sessions in total. There were no complications or communication interruptions once the system communication proved stable after the first minute. In 26 sessions, initial communication was interrupted upon device interrogation, requiring communication to be re-established (which sometimes necessitated switching to an alternative carrier). Clinically driven parameter reprogramming was performed in 58 RC sessions (39%). Programming of notations concerning RC sessions was performed in all 300 sessions. The average duration of the RC sessions was 11 min. Patients' satisfaction scored 4.5 out of 5 points. In conclusion, RC management of cardiac devices at patients' homes is safe, effective, convenient, and associated with high patient satisfaction. This technology may prove very useful in a changing health care delivery system, especially amid the coronavirus disease 2019 pandemic.

RESUMEN

Background: Due to seriously imbalanced distribution of follow-up clinics in China, routine in-office visits are erratically attended by many cardiovascular implantable electronic device (CIED) patients. Meanwhile, remote monitoring is significantly underutilized. Novel tools to address the current predicament of routine in-office visits in China is urgently needed. Objectives: To assess the reliability and feasibility of cloud follow-up in CIED patients. Methods: A total of 325 CIED patients from 13 hospitals in Sichuan Province, China, were enrolled. Information on patients' sociodemographic and basic clinical characteristics was collected. All devices were tested and programmed with 5G-cloud follow-up platform in a real-time manner. All patients were surveyed about their acceptance of and preferences regarding cloud follow-up compared to routine in-office visits. Results: Compliance with routine in-office visits in this region was 60.6%. None of the patients were enrolled in remote monitoring services. Clinically important predictors of non-compliance were elderly age (≥75 years old), odds ratio (OR) 2.392 (95% confidence interval, 1.111-5.150); needing notification from a follow-up clinic, OR 2.518 (1.179-5.376); and being beyond 15 months post-implantation, OR 5.440 (2.563-11.543). All cloud follow-up sessions were performed safely and efficiently, without any adverse events. 292 (89.8%) patients preferred cloud follow-up for future device management. Conclusion: Compliance with routine in-office visits in this region has much room for improvement. Cloud follow-up addresses the limitations of an imbalanced distribution of follow-up clinics and geographic barriers for in-office CIED evaluation. Thus, cloud follow-up provides a potential solution to the current predicament of routine in-office visits in China.

RESUMEN

Remote monitoring of permanent pacemakers and implantable cardiac defibrillators has undergone considerable advances over the past several decades. Advancement of technology has created the ability for remote monitoring of implantable cardiac devices; a device can monitor its own function, record arrhythmias, and transmit data to health care providers without frequent in-office checks, shown to be as safe as in-office interrogation. Remote monitoring allows earlier detection of clinically actionable events, reduces incidence of inappropriate shocks, and allows earlier detection of atrial fibrillation. App-based remote monitoring provides patients with rapid access to their cardiac data, which may improve compliance with remote monitoring.

Asunto(s)

RESUMEN

BACKGROUND: In the era of COVID-19, travel restrictions and social distancing measures have changed the landscape for device interrogations of pacemakers and defibrillators for rural Victorians. Previously, device checks were performed infrequently in large volume, face-to-face rural clinics by visiting cardiologists and technicians. Access to remote areas and social distancing restrictions have made these clinics unfeasible to operate. The Cardiac Society of Australia and New Zealand (CSANZ) and Heart Rhythm Society (HRS) COVID-19 consensus statements have suggested the utilisation of remote monitoring to minimise the potential spread of COVID-19 infections between clinicians and high-risk patients. A novel solution to this challenge was the implementation of a remote device interrogation (RI) service located in two kiosks at two rural pharmacies. This service was termed Remote Device Interrogation Kiosks (ReDInK). AIM: This cross-sectional observational study aimed to describe the set-up process, safety and efficacy of RI and customer satisfaction of the ReDInK program. METHODS: Two-hundred-and-ninety-two (292) rurally located patients with implantable cardiac devices were identified via the cardiology department database. Of these, 101 (44%) were enrolled into the ReDInK program across two rurally located pharmacies between April and July 2020. RI was performed and download outcomes were reviewed. A customer satisfaction survey assessed attitudes towards the program and explored options of ongoing service application. RESULTS: Of 101 patients enrolled into ReDInK, 96 (95%) resulted in satisfactory device checks. Four (4) individuals failed-to-attend and one individual experienced technical download issues. Of the 96 satisfactory device checks, three required in-person follow-up for reasons including battery replacement, lead repositioning and in-person programming. No adverse events were reported. A satisfaction telephone survey was conducted with 81 (83%) participants enrolled in ReDInK. Seventy-one (71) individuals (88%) of those surveyed expressed satisfaction and 73 (90%) labelled the process as efficiently conducted. Sixty-nine (69) (85%) participants felt reassured that this service was established during the pandemic. However 47 (58%) participants reported they would still feel comfortable to undergo in-person reviews despite social distancing recommendations. CONCLUSIONS: With the COVID-19 pandemic posing restrictions to social distancing and reducing unnecessary in-person interaction, the ReDInK program emerges as an efficacious and safe solution for patients in rural Victoria. The program's widely positive reception and successful conduction in rural Victoria invites further opportunity for a wider application of similar programs, expanding its role to metropolitan areas.

Asunto(s)

RESUMEN

AIMS: This trial aimed to evaluate the safety and efficiency of a common and simplified protocol for the surveillance of cardiac implantable electronic devices based on remote monitoring (RM) in patients with pacemakers (PMs) and implantable cardiac defibrillators (ICDs) for at least 24 months. METHODS AND RESULTS: The RM-ALONE is a multicentre prospective trial that randomly assigned 445 patients in two groups, both followed by RM: the home monitoring-only (HMo) based on RM + remote interrogations (RIs) every 6 months and the HM + IO that adds in-office evaluations every 6 months to RM. Four hundred and forty-five patients were enrolled in the study, 294 PMs and 151 ICDs recipients. In the HMo group, 20% of patients experienced ≥1 major adverse cardiac event (MACE) vs. 19.5% in HM + IO group (P = 0.006 for non-inferiority). The proportion of patients with a PM/ICD who experienced ≥1 MACE was 15.2/29.3% in HMo group and 16.1/26.3% in HM + IO group (hazard ratio 0.95/1.15, 95% confidence interval 0.53-1.70/0.62-2.10). There were 789 in-office evaluations (136 in the HMo and 653 in the HM + IO; P < 0.001). There was a 79.2% reduction of in-office evaluations with no significant differences in unscheduled visits between groups: 122 (54.5%) in HMo and 101 (45.3%) in HM + IO; P = 0.15. The time a physician/nurse spent per patient/follow-up was significantly reduced in the HMo group: 4/5 min (0-30)/(1-30) vs. 10/10 min (0-40)/(1-40) in HM + IO (P < 0.0001). CONCLUSION: The RM-ALONE protocol common for ICD and PM surveillance, consisting of RM + RI every 6 months has proven safe and efficient in reducing hospital visits and staff workload.

Asunto(s)

RESUMEN

BACKGROUND: Non-sustained ventricular tachycardia (NSVT) can occur asymptomatically and can be incidentally detected in the internal records of pacemakers (PM). The clinical value of NSVT in the population of PM patients is still uncertain.Our aim was to assess the prevalence of NSVT detected by remote PM control, to describe the clinical and demographic characteristics of patients with NSVT, and to assess the prognostic significance of NSVT in terms of both overall and cardiovascular mortality. METHODS: Consecutive patients followed with PM remote interrogations from September 2010 to December 2015 were included. The transmissions pertaining to the first 12 months of remote control were analysed and the patients were divided by those presenting NSVT and those without NSVT. The two groups were compared in terms of total mortality and cardiovascular mortality based on the administrative data provided by the regional administration of the Italian National Health System. RESULTS: The prevalence of NSVT in 408 patients (62% males, mean age 75.6; SD 10.6 years old) was 21% in a year. During a mean follow-up duration of 44 months, NSVT did not emerge as independently associated with overall mortality, but was associated with cardiovascular mortality in a competing risk regression model with older age, male gender, diabetes, chronic renal insufficiency, ischemic cardiomyopathy and chronic obstructive pulmonary disease. CONCLUSIONS: We show that NSVT episodes recorded by remote control in a PM population are independently associated with cardiovascular mortality with possible implications for risk stratification and therapeutic options.

RESUMEN

Remote monitoring in the modern era has improved outcomes for patients with cardiac implantable electronic devices. There are many advantages to remote monitoring, including improved quality of life for patients, decreased need for in-office interrogation, and secondary reduced costs. Patient safety and enhanced survival remain the most significant benefit. With most of the published literature on this topic being focussed on adults, paediatric outcomes continue to be defined. This is a review of the benefits of remote monitoring in paediatrics and in patients with CHD.

Asunto(s)

RESUMEN

BACKGROUND: Device follow-up is mandatory in the care of patients with a pacemaker. However, in most cases, device checks appear to be mere technical, time-consuming procedures. The aim of this research is to evaluate whether remote follow-up can replace in-clinic device checks by assessing clinical outcomes for pacemaker patients followed only via remote follow-up. METHODS AND RESULTS: Consecutive pacemaker patients followed with remote monitoring were prospectively included by 6 Italian cardiology centers in an observational investigation. The workflow for remote monitoring included an initial assessment by nursing staff and, when necessary, by a responsible physician for medical decisions. No in-person visits were scheduled after the start of remote monitoring. One-thousand and two-hundred and fifty one patients (30% female, 75±11years old) were followed for a median observation period of 15months. Out of 4965 remote transmissions, 1882 (38%) had at least one clinically relevant event to be investigated further, but, only after 137 transmissions (2.8%), the patients were contacted for an in-clinic visit or hospitalization. Sixty-nine patients died and 124 were hospitalized for various reasons. Atrial fibrillation episodes were the most common clinical events discovered by remote transmissions, occurring in 1339 (26%) transmissions and 471 (38%) patients. CONCLUSIONS: Our experience shows that remote monitoring in a pacemaker population can safely replace in-clinic follow-up, avoiding unnecessary in-hospital device follow-up.

Asunto(s)