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BACKGROUND: The ruling n. 38485, 20 June 2019, of the Italian Supreme Court, III criminal section, addressed by the perspective of the law the very sensitive and new issue of telemedicine. OBJECTIVE: This commentary deals with the issue of authorization of telemedicine activities by the health authority, starting from the Italian Court of Criminal Cassation, III section, decision n. 38485/2019. The case law explored the authorization of a health point, which carries out telemedicine services. METHODS: Starting from the perspective discussed by Italian health regulations, the paper examines how the health act could be defined, with the possibilities offered by telecommunications, and how it now relates legally to the physical place where it takes place. RESULTS: Even if telemedicine opens the way to virtual spaces of health practice, the Ministry of Health Italian Guidelines pose functional and logistical issues to guarantee users' safety and health care system accountability. Then, functional requirements for health legitimate practice, and their continuous monitoring, together with the responsibilities of the service centers, health professionals and health facilities, are discussed. CONCLUSION: The questioning of States' health law, in a broad health system such as that of the Europe, characterized by autonomous health regulations, is extremely important for cross-border health policy with telemedicine, as overall regulatory compliance in health care is the ground criterion for risk prevention and patient safety, to be properly verified.

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OBJECTIVE: To evaluate the short- and long-term effect of remote synchronous fine-tuning and follow-up visits on hearing-related problems and hearing aid (HA) benefits for first-time HA users. DESIGN: A randomised controlled trial. STUDY SAMPLE: Patients at public tax-funded HA clinics in Sweden due for aural rehabilitation (AR) were randomised to either an intervention group (n = 33) or a control group (n = 36). Both groups completed the conventional AR process, but the intervention group received synchronous remote fine-tuning of HAs and online follow-up visits. Outcome measures were used before and after intervention, and 6 months and 1 year after intervention. RESULTS: Both groups improved hearing-related problems measured with the Hearing Handicap Inventory for the Elderly/Adults over time, and no significant differences were found between the groups. Such improvements were also found for the Abbreviated Profile of Hearing Aid Benefit except for the subscale aversiveness. Both groups decreased the use of HAs in hours/day over time. The intervention group reported significant improvements in activity limitation when measured directly after the intervention, compared to the control group. CONCLUSION: Synchronous remote fine-tuning and follow-ups for first-time HA users did not influence the outcomes of hearing-related problems and HA benefits differently from standard care at our clinic.

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BACKGROUND: Chronic kidney disease (CKD) is a significant public health concern, and patient self-management is an effective approach to manage the condition. Mobile applications have been used as tools to assist in improving patient self-management, but their effectiveness in long-term outpatient follow-up management of patients with CKD remains to be validated. This study aimed to investigate whether using a mobile application combined with traditional outpatient follow-up can improve health outcomes of patients with CKD . METHODS: This retrospective cohort study recruited CKD patients with stage 1-5 who were not receiving renal replacement therapy from a CKD management center. Two groups were established: the APP + outpatient follow-up group and the traditional outpatient follow-up group. Baseline data was collected from January 2015 to December 2019, followed by a three-year long-term follow-up until December 2022. Laboratory data, all-cause mortality, and renal replacement treatment were then collected and compared between the two groups. RESULTS: 5326 patients were included in the study, including 2492 in the APP + outpatient group and 2834 in the traditional outpatient group. After IPTW virtualization matching, the final matched the APP + outpatient group consisted of 2489 cases (IQR, 33-55) and 2850 (IQR, 33-55) in the traditional outpatient group. By the end of the study, it was observed that the laboratory data of Phosphorus, Sodium, Triglyceride, Hemoglobin showed significant improvements, Furthermore the APP + outpatient group demonstrated superior results compared to the traditional outpatient group (P < .05). And it was observed that there were 34 deaths (1.4%) in the APP + outpatient group and 46 deaths (1.6%) in the traditional outpatient group(P = .49). After matching for renal replacement therapy outcomes, the two groups were found to be comparable (95% CI [0.72-1.08], P = .23), with no significant difference. However, it was noted that the traditional outpatient group had a lower incidence of using temporary catheters during initial hemodialysis (95% CI [8.4-29.8%], P < .001). CONCLUSION: The development and application of an app combined with outpatient follow-up management can improve patient health outcomes. However, to ensure optimal preparation for kidney replacement therapy, patients in CKD stages 4-5 may require more frequent traditional outpatient follow-ups, and further develop an information-based decision-making support tool for renal replacement therapy.

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BACKGROUND: Randomized controlled trials typically require study-specific visits, which can burden participants and sites. Remote follow-up, such as centralized call centers for participant-reported or site-reported, holds promise for reducing costs and enhancing the pragmatism of trials. In this secondary analysis of the CONNECT-HF (Care Optimization Through Patient and Hospital Engagement For HF) trial, we aimed to evaluate the completeness and validity of the remote follow-up process. METHODS AND RESULTS: The CONNECT-HF trial evaluated the effect of a post-discharge quality-improvement intervention for heart failure compared to usual care for up to 1 year. Suspected events were reported either by participants or by health care proxies through a centralized call center or by sites through medical-record queries. When potential hospitalization events were suspected, additional medical records were collected and adjudicated. Among 5942 potential hospitalizations, 18% were only participant-reported, 28% were reported by both participants and sites, and 50% were only site-reported. Concordance rates between the participant/site reports and adjudication for hospitalization were high: 87% participant-reported, 86% both, and 86% site-reported. Rates of adjudicated heart failure hospitalization events among adjudicated all-cause hospitalization were lower but also consistent: 45% participant-reported, 50% both, and 50% site-reported. CONCLUSIONS: Participant-only and site-only reports missed a substantial number of hospitalization events. We observed similar concordance between participant/site reports and adjudication for hospitalizations. Combining participant-reported and site-reported outcomes data is important to capture and validate hospitalizations effectively in pragmatic heart failure trials.

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Background: Medication abortion (MAB) follow-up historically involves visiting a health care facility for ultrasonography or laboratory testing. In rural states such as New Mexico, many patients travel hours for MAB, making two visits burdensome. Studies demonstrate feasibility, safety, and patient preference for remote follow-up. Materials and Methods: We evaluated whether MAB follow-up by telephone had noninferior loss-to-follow-up (LTFU) rates compared with ultrasonography or laboratory follow-up in a rural population. This was a retrospective chart review of University of New Mexico MAB LTFU rates after changing to telephone follow-up (home group, n = 136). Patients were propensity-matched in a 1:2 ratio to a historical cohort (health care group, n = 272) to eliminate significant differences. We defined LTFU as no contact within 50 days. We evaluated complications requiring intervention, possible ongoing pregnancy, completion of the home follow-up protocol (7- and 30-day calls, high-sensitivity urine pregnancy test [UPT]), follow-up by intended method (home or health care), and number of call attempts. Results: LTFU rates for the home group (n = 23, 17%) were noninferior to the health care group (n = 60, 22%, p = 0.24). Rates of complications requiring intervention (p = 0.83) and possible ongoing pregnancy (p = 0.72) among the home group were similar to the health care group. Ninety-seven (71%) home group patients completed the initial call, 79 (58%) completed the UPT, and 86 (69%) completed the 30-day call. Ninety-five (70%) home group patients followed up by intended method, comparable with the health care group (n = 199, 73%, p = 0.56). Staff made a median of 3 (interquartile range: 2-4) calls per home group patient. Conclusions: Remote MAB LTFU rates were noninferior to in-person LTFU rates.

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INTRODUCTION: Therapeutic approaches in Multiple Myeloma (MM) have considerably changed over the last few years, with effective oral chemotherapy and continuous treatment. In this context, the objective of this study was to examine the circuitry of an advanced practitioner nurse (APN)-led intervention that provided supportive care for MM patients treated with oral chemotherapy. METHODS: This population-based study was conducted at the hematology department - Institut de Cancérologie Lucien Neuwirth (ICLN, Saint-Priest-en-Jarez), from April 2017 to September 2020. A follow-up program was established with a specialized APN in oncology. RESULTS: All APN interventions were recorded, representing 1240 phone calls and 162 consultations for 42 MM patients. Eighty-two calls were referred to the physician with 45 consultations triggered. Most of the calls were frequent within the few first months, with a high request for information and reassurance, especially for treatment-naive or relapsed patients. In our study, the APN was able to manage multiple side effects through care organization (i.e., hospitalizations, transfusions) and a careful coordination between the primary care team and the hospital. DISCUSSION: In order to respond to the high need for care pathway and safety improvement, especially in elderly population, we have initiated an original follow-up by an APN for MM patients treated with oral chemotherapy. While the role of APN has become prominent in the oncology field in recent years, its holistic approach has to be emphasized in further studies to bring a comprehensive perspective to health care coordination in the future.

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BACKGROUND/AIM: Clinical assessment of wounds for surgical site infection (SSI) after hospital discharge is challenging and resource intensive. Remote assessment using digital images may be feasible and expedite SSI diagnosis. Acceptable and accurate methods for this process are needed. This study developed and evaluated the feasibility, acceptability and usability of a method for patients to capture standardised wound images for remote wound assessment to detect SSI. MATERIALS AND METHODS: The work was conducted in two phases. Phase I involved: i) a review of literature to identify key components of photography relevant to taking wound images, ii) development of wound photography instructions for patients and a secure process for transmission of images using electronic survey software and iii) pre-testing of the photography instructions and processing method with a sample of 16 patients using cognitive interviews and observations. Phase II involved a prospective cohort study of 89 patients to evaluate the feasibility, acceptability and usability of the remote method following discharge from hospital after surgery. Quality of the images was assessed by three independent clinical reviewers. RESULTS: Some 21 key components for photographing wounds were identified from 11 documents. Of these, 16 were relevant to include in instructions for patients to photograph their wounds. Pre-testing and subsequent iterations improved understanding and ease of use of the instructions and the process for transmitting images. Fifty-two of 89 (58.4%) patients testing the method remotely took an image of their wound(s) and 46/52 (88.5%) successfully transmitted images. When it was possible to ascertain a reason for not taking/transmitting images, this was primarily health problems (n = 7) or lack of time/poor engagement with the study (n = 4) rather than problems relating to technology/competency (n = 2) or practical issues relating to the wound itself (n = 2). Eighty-seven (85.3%) of the 102 images received were evaluated to be of high quality and sufficient to remotely assess SSI by at least two independent reviewers. CONCLUSION: A simple, standardised and acceptable method for patients to take and transmit wound images suitable for remote assessment of SSI has been developed and tested and is now available for use in routine clinical care and research.

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BACKGROUND: Alert-driven remote patient monitoring (RPM) or fully virtual care without routine evaluations may reduce clinic workload and promote more efficient resource allocation, principally by diminishing nonactionable patient encounters. OBJECTIVE: The purpose of this study was to conduct a cost-consequence analysis to compare 3 postimplant implantable cardioverter-defibrillator (ICD) follow-up strategies: (1) in-person evaluation (IPE) only; (2) RPM-conventional (hybrid of IPE and RPM); and (3) RPM-alert (alert-based ICD follow-up). METHODS: We constructed a decision-analytic Markov model to estimate the costs and benefits of the 3 strategies over a 2-year time horizon from the perspective of the US Medicare payer. Aggregate and patient-level data from the TRUST (Lumos-T Safely RedUceS RouTine Office Device Follow-up) randomized clinical trial informed clinical effectiveness model inputs. TRUST randomized 1339 patients 2:1 to conventional RPM or IPE alone, and found that RPM was safe and reduced the number of nonactionable encounters. Cost data were obtained from the published literature. The primary outcome was incremental cost. RESULTS: Mean cumulative follow-up costs per patient were $12,688 in the IPE group, $12,001 in the RPM-conventional group, and $11,011 in the RPM-alert group. Compared to the IPE group, both the RPM-conventional and RPM-alert groups were associated with lower incremental costs of -$687 (95% confidence interval [CI] -$2138 to +$638) and -$1,677 (95% CI -$3134 to -$304), respectively. Therefore, the RPM-alert strategy was most cost-effective, with an estimated cost-savings in 99% of simulations. CONCLUSIONS: Alert-driven RPM was economically attractive and, if patient outcomes and safety are comparable to those of conventional RPM, may be the preferred strategy for ICD follow-up.

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Telemedicine is the combination of technologies and activities that offer new remote ways of medical care. The Sm@rtEven application project is a remote assistance service that follows patients affected by lower limb fractures surgically treated at Galeazzi Orthopedic Institute (Milan, Italy). The Sm@rtEven application aims to evaluate the clinical conditions of patients treated for lower limb fracture after discharge from hospital using remote follow-up (FU). The project is not a substitute for traditional clinical consultations but an additional tool for a more complete and prolonged view over time. The Sm@rtEven application is installed on patients' smartphones and is used daily to communicate with healthcare personnel. In the first protocol, patients had to complete different tasks for 30 days, such as monitoring the load progression on the affected limb, the number of steps during the day, and body temperature and completing a questionnaire. A simplified protocol was proposed due to the pandemic and logistical issues. The revised protocol enrolled patients after more than 30 days of their operation, prioritized the rehabilitation phase, and required patients to use the app for fewer days. After an initial phase of correct use, a reduction in patient compliance was gradually reported in the first protocol. However, patient compliance in the second protocol remained high (96.25%) in the recording of all the required parameters. The Sm@rtEven application has proven to be a valuable tool for following patients remotely, especially during the pandemic. Telemedicine has the same value as traditional clinical evaluations, and it enables patients to be followed over long distances and over time, minimizing any discomfort.

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OBJECTIVE: The purpose of this study was to explore the effect of WeChat-based remote follow-up management on reducing the home care burden and anxiety of parents of premature infants. METHODS: A randomized controlled study was conducted in our hospital, with 150 premature infants enrolled in this study, each with 75 cases in the intervention group and the control group. WeChat-based remote follow-up management was performed in the intervention group after discharge, while traditional outpatient follow-up management was performed in the control group. Zarit Burden Interview (ZBI) scale as the primary outcome was used to compare the parental care burden between the two groups. RESULTS: At the 1-month follow-up, the ZBI (37.1 ± 8.3 vs. 54.2 ± 10.5 [mean ± SD], mean difference: 17.1, the 95% confidence interval for the mean difference: [14.07, 20.13], P = 0.016), Family Caregiver Task Inventory (FCTI) scale (23.1 ± 5.2 vs. 33.4 ± 6.7 [mean ± SD], mean difference: 10.3, the 95% confidence interval for the mean difference: [8.38, 12.22], P = 0.023), Self-Rating Anxiety Scale (SAS) (49.6 ± 8.5 vs. 60.2 ± 10.8 [mean ± SD], mean difference: 10.6, the 95% confidence interval for the mean difference: [7.49,13.71], P = 0.021) and Self-Rating Depression Scale (SDS) (48.2 ± 9.5 vs. 58.8 ± 11.2 [mean ± SD], mean difference: 10.6, the 95% confidence interval for the mean difference: [7.28, 13.92], P = 0.019) scores of the intervention group were lower than those of the control group, and the lower scores indicate better outcomes. CONCLUSION: WeChat-based remote follow-up management of premature infants after discharge can effectively improve parents' ability to care and their psychological state and reduce burden of care.

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BACKGROUND: Patients with cystic fibrosis (CF) are considered to be a COVID-19 risk group. In March 2020, a fast-track Patient Reported Outcome (PRO) solution was developed to ensure access to CF care without in-person hospital visits. This study investigated the feasibility of urgently replacing in-person appointments with remote monitoring using telephone consultations combined with PROs. We investigated patients and health care professionals' (HCPs) acceptance, recruitment rate, response rate, missing data, and attrition. METHODS: We included adult CF patients from the Department of Infectious Diseases at Aarhus University Hospital, Denmark between April and June 2020. Patients filled in a disease-specific questionnaire including relevant clinical aspects, performed home spirometry, and sent in a sputum sample before a scheduled telephone consultation. Twelve participants who completed the questionnaire and had a telephone consultation were interviewed. Three physicians and three nurses from the CF clinical team participated in a focus group interview. RESULTS: Eighty patients were recruited for remote monitoring, and 41 patients filled in at least one questionnaire. Overall, both patients and HCPs found remote monitoring and use of PROs acceptable and useful. Patients experienced greater flexibility and found the questionnaire relevant and understandable but pointed out the need for items regarding mental health status and more adequate information about changes in follow-up and workflow. CONCLUSION: Urgent reorganization of outpatient follow-up among CF patients due to COVID-19 was feasible in routine clinical practice. However, patient involvement should be a future point of attention to ensure a sustainable telehealth PRO solution.

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BACKGROUND: Artificial intelligence (AI), such as machine learning (ML), shows great promise for improving clinical decision-making in cardiac diseases by outperforming statistical-based models. However, few AI-based tools have been implemented in cardiology clinics because of the sociotechnical challenges during transitioning from algorithm development to real-world implementation. OBJECTIVE: This study explored how an ML-based tool for predicting ventricular tachycardia and ventricular fibrillation (VT/VF) could support clinical decision-making in the remote monitoring of patients with an implantable cardioverter defibrillator (ICD). METHODS: Seven experienced electrophysiologists participated in a near-live feasibility and qualitative study, which included walkthroughs of 5 blinded retrospective patient cases, use of the prediction tool, and questionnaires and interview questions. All sessions were video recorded, and sessions evaluating the prediction tool were transcribed verbatim. Data were analyzed through an inductive qualitative approach based on grounded theory. RESULTS: The prediction tool was found to have potential for supporting decision-making in ICD remote monitoring by providing reassurance, increasing confidence, acting as a second opinion, reducing information search time, and enabling delegation of decisions to nurses and technicians. However, the prediction tool did not lead to changes in clinical action and was found less useful in cases where the quality of data was poor or when VT/VF predictions were found to be irrelevant for evaluating the patient. CONCLUSIONS: When transitioning from AI development to testing its feasibility for clinical implementation, we need to consider the following: expectations must be aligned with the intended use of AI; trust in the prediction tool is likely to emerge from real-world use; and AI accuracy is relational and dependent on available information and local workflows. Addressing the sociotechnical gap between the development and implementation of clinical decision-support tools based on ML in cardiac care is essential for succeeding with adoption. It is suggested to include clinical end-users, clinical contexts, and workflows throughout the overall iterative approach to design, development, and implementation.

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OBJECTIVE: COVID-19 pandemic represents a serious health emergency that severely compromised our Public Health system, resulting in a rapid and forced reorganization and involved the management of chronic diseases too. The Scleroderma Unit of Modena and Reggio Emilia follows more than 600 patients suffering from systemic sclerosis (SSc) and recently became the referral center (HUB) in Emilia-Romagna for this rare connective tissue disease. The aim of the present study was to evaluate the extent by which the lockdown and the pandemic has impacted the activity of admissions to Scleroderma Unit of Modena and Reggio Emilia. METHODS: Our daily clinical activity is characterized by outpatient visits, videocapillaroscopy exam, ulcers treatment, therapeutic infusions in day hospital regimen, multidisciplinary visits following our dedicated SSc care pathway, and clinical trials. Our activity has been quickly rescheduled to ensure the proper assistance to our SSc patients during the COVID-19 pressure. RESULTS: The use of telemedicine has certainly assured a robust continuity of health care. Furthermore, telephone pre-triage, nurse/medical triage, proper physical distancing and use of PPE/DPI allowed us to re-organize and continue SSc daily activity. Specifically, therapeutic infusions in day hospital regimen and outpatient visits, including ulcers treatment, was guaranteed and maximized. CONCLUSION: The management of scleroderma patients by an expert specialist reference center is crucial in order to ensure continuity of care and pursue the best SSc practice.

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Health care systems face an expansion in the number of older individuals with a high prevalence of neurodegenerative diseases and related behavioral and psychological symptoms of dementia (BPSDs). Health care providers are expected to develop innovative solutions to manage and follow up patients over time in the community. To date, we are unable to continuously and accurately monitor the nature, frequency, severity, impact, progression, and response to treatment of BPSDs after the initial assessment. Technology could address this need and provide more sensitive, less biased, and more ecologically valid measures. This could provide an opportunity to reevaluate therapeutic strategies more quickly and, in some cases, to treat earlier, when symptoms are still amenable to therapeutic solutions or even prevention. Several studies confirm the relationship between sensor-based data and cognition, mood, and behavior. Most scientific work on mental health and technologies supports digital biomarkers, not so much as diagnostic tools but rather as monitoring tools, an area where unmet needs are significant. In addition to the implications for clinical care, these real-time measurements could lead to the discovery of new early biomarkers in mental health. Many also consider digital biomarkers as a way to better understand disease processes and that they may contribute to more effective pharmaceutical research by (i) targeting the earliest stage, (ii) reducing sample size required, (iii) providing more objective measures of behaviors, (iv) allowing better monitoring of noncompliance, (v) and providing a better understanding of failures. Finally, communication technologies provide us with the opportunity to support and renew our clinical and research practices.

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Device interrogation and management are time consuming, representing a relevant burden for pacing centers. In several situations, patients' management requires additional follow up visits. Remote Monitoring (RM) allows an optimal recall management and a rapid diagnosis of device or lead failure, without the need of additional in office visits. Further it allows a significant delay reduction between the adverse event and the reaction to the alarm, shortening the time needed to make a clinical decision. A role in risk-predicting patient-related outcomes has also been shown. RM permits detection of the arrhythmia from 1 to 5 months in advance compared to in-office visits. Importantly, by using specific algorithms with multiparametric analysis, RM has been studied as a potential instrument to identify early patients on risk of worsening HF using specific algorithms. Although the use of RM in HF setting remains controversial, it has been proposed to improve HF clinical outcomes and survival in clinical trials. In this sense, RM success could require a standardization of process within a management model, that may involve different health care professionals. In this review, we examine recent advances of RM providing an update of this tool through different clinical scenarios.

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In addition to the telemedical follow-up at a fixed point in time, there is the possibility of a close-meshed telemetric monitoring in modern devices. By transferring device and patient-specific data, errors in the integrity of the device or electrodes and cardiac arrhythmias can be detected early, in various studies significantly reducing the number of outpatient or inpatient visits and the rate of inadequate implantable cardioverter-defibrillator (ICD) therapies. Measurement of various surrogate parameters allows better clinical assessment of heart failure patients, yet no improvement in outcome with therapy guided by telemetric data has been demonstrated. Retrospective analyzes, a prospective randomized study, and various meta-analyzes identified a reduction in all-cause mortality through the use of remote monitoring. This effect is mainly due to monitoring as closely as possible, timely examination of the findings, accordingly early interventions and specification of clear therapeutic regimens in certain clinical scenarios. Such comprehensive patient care requires the creation of telemonitoring centers with appropriate structural and personal equipment, whereby the creation of such structures has not yet been remunerated in the German healthcare system. In this paper, an overview of remote monitoring and identify possibilities and limitations of device-based telemedical monitoring is provided.

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BACKGROUND: Remote monitoring (RM) is an established technology integrated into routine follow-up of patients with an implantable cardioverter-defibrillator (ICD). Current RM systems differ according to transmission frequency and alert definition. OBJECTIVE: The purpose of this study was to compare the time difference between detection and acknowledgment of clinically relevant events between 4 RM systems. METHODS: We analyzed time delay between detection of ventricular arrhythmic and technical events by the ICD and acknowledgment by hospital staff in 1802 consecutive patients followed with RM between September 2014 and August 2016. Devices from Biotronik (BIO; n = 374), Boston Scientific (BSC; n = 196), Medtronic (MDT; n = 468), and St Jude Medical (SJM; n = 764) were included. We identified all events from RM web pages and their acknowledgment with RM or at in-clinic follow-up. Events that occurred during weekends were excluded. RESULTS: We included 3472 events. Proportion of events acknowledged within 24 hours was 72%, 23%, 18%, and 65% with BIO, BSC, MDT, and SJM, respectively, with median times of 13, 222, 163, and 18 hours from detection to acknowledgment (P <.001 for both comparisons between manufacturers). Including only events transmitted as alerts by RM, 72%, 68%, 61%, and 65% for BIO, BSC, MDT and SJM, respectively, were acknowledged within 24 hours. Variation in time to acknowledgment of ventricular tachyarrhythmia episodes not treated with shock therapy was the primary cause for the difference between manufacturers. CONCLUSION: Significant and clinically relevant differences in time delay from event detection to acknowledgment exist between RM systems. Varying definitions of which events RM transmits as alerts are important for the differences observed.

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Telemonitoring (TM) features are implemented in nearly all cardiac implantable electronic devices (CIEDs) that have recently been released to the market. In combination with pacemakers, defibrillators and systems for cardiac resynchronization it is a safe and efficient method for routine technical aftercare of the devices as well as for monitoring heart failure and arrhythmias. Using TM has the potential to optimize patient care with regard to economic, clinical and safety aspects. Despite the good availability of existing data and clear recommendations of the responsible scientific societies, it is often seen as an isolated solution which is not fully integrated into standard care, although it has its own EBM number for implantable cardioverter-defibrillators and cardiac resynchronization therapy systems. The reasons are not only the unsatisfactory reimbursement of costs, different IT structures and the borders between clinics and medical practices, but also acceptance problems of physicians and legal aspects. The compensation of cardiac pacemakers and 'event recorders' is unsolved. TM provides the prospect for optimal and cross-sectoral patient care. Furthermore it has the potential to become the standard method for the care for patients with a CIED.

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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.

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