Long-term cost-utility analysis of remote monitoring of older patients with pacemakers: the PONIENTE study.

BACKGROUND: Cost-effectiveness studies on pacemakers have increased in the last years. However the number of long-term cost-utility studies is limited. The objective of this study was to perform a cost-utility analysis comparing remote monitoring (RM) versus conventional monitoring (CM) in hospital of older patients with pacemakers, 5 years after implant. METHODS: Under a controlled, not randomized, nor masked clinical trial, 83 patients with pacemakers were initially selected. After five years of follow-up, a total of 55 patients (CM = 34; RM = 21) completed the study. A cost-utility analysis of RM in terms of costs per gained quality-adjusted life years (QALYs) was conducted. The costs from the Public Health System (PHS) as well as patients and their relatives were taken into account for the study. The robustness of the results was verified by the probabilistic analyses through Monte-Carlo simulations. RESULTS: After a five-year follow-up period, total costs were lower in the RM group by 23.02% than in the CM group (€274.52 versus €356.62; p = 0.033) because of a cost saving from patients' perspective (€59.05 versus €102.98; p = 0.002). However, the reduction of in-hospital visits derived from RM exhibited insignificant impact on the costs from the PHS perspective, with a cost saving of 15.04% (€215.48 vs. €253.64; p = 0.144). Costs/QALYs obtained by the RM group were higher as compared to the CM group, although there were no significant differences. The incremental cost-effectiveness ratio of CM in comparison to RM became positive (€301.16). CONCLUSIONS: This study confirms RM of older patients with pacemakers appears still as a cost-utility alternative to CM in hospital after 5 years of follow-up. TRIAL REGISTRATION: ClinicalTrials.gov: (Identifier: NCT02234245 ). Registered 09 September 2014 - Prospectively registered.

Correction: A non-randomized clinical trial to examine patients' experiences and communication during telemonitoring of pacemakers after five years follow-up.

[This corrects the article DOI: 10.1371/journal.pone.0261158.].

A non-randomized clinical trial to examine patients' experiences and communication during telemonitoring of pacemakers after five years follow-up.

Patients with pacemakers need regular follow-ups which are demanding. Telemonitoring for pacemaker can provide a new opportunity to avoid follow-up visits. On the other hand, in-person visits could help patients with pacemakers to cope better with the anxiety linked to their condition and maintain better communication with their doctors than simple remote control of their device status. Therefore, our objective was to analyze the experiences and communication comparing telemonitoring (TM) versus conventional monitoring (CM) of patients with pacemakers. A single-center, controlled, non-randomized, non-blinded clinical trial was designed. Data were collected five years after implantation in a cohort of 89 consecutive patients assigned to two different groups: TM and CM. The 'Generic Short Patient Experiences Questionnaire' (GS-PEQ) was used to assess patients' experiences, and the Healthcare Communication Questionnaire (HCCQ) was used to measure the communication of patients with healthcare professionals. Additionally, an ad-hoc survey including items from the 'Telehealth Patient Satisfaction Survey' and a 'costs survey' was used. After five years, 55 patients completed the study (TM = 21; CM = 34). Participants' mean (±SD) age was 81 (±6.47), and 31% were females. No differences in baseline characteristics between groups were found. The comparative analyses TM versus CM showed some significant differences. According to GS-PEQ, TM users received adequate information about their diagnosis or afflictions (p = .035) and the treatment was better adapted to their situation (p = .009). Both groups reported negative experiences regarding their involvement in their treatment decisions, the waiting time before admission, and perceived a low-benefit. According to HCCQ, the TM group experienced poorer consultation management by the healthcare provider (p = .041). Participants reported positive overall communication experiences. The study provides insights into the experiences and communication in PM monitoring services as well as specific areas where users reported negative experiences such as the consultation management by clinicians. Trial registration: ClinicalTrials.gov NCT02234245.

Effectiveness and Safety in Remote Monitoring of Patients with Pacemakers Five Years after an Implant: The Poniente Study.

Health-related quality of life (HRQoL) and functional capacity values immediately after pacemaker (PM) implantation have been well established; however, not much has been known about its long-term effects. The present study compared the long-term effectiveness and safety of remote monitoring plus a clinic visit versus clinic visits alone during follow-up of adults implanted with PMs. This study was a single-centre, controlled, non-randomised, non-blinded clinical trial. Data were collected pre-implantation and after 60 months. The patients in the PONIENTE study were assigned to two different groups: remote monitoring (RM) and conventional monitoring (CM). The EuroQol-5D (EQ-5D) questionnaire was used to assess HRQoL and Duke Activity Status Index was used for the functional capacity. After five years, 55 patients completed the study (RM = 21; CM = 34). EuroQol-5D and functional capacity values were improved; however, significant differences were observed only in the EQ5D visual analogue scale (p < 0.001). Remote monitoring was equally feasible, reliable, safe, and clinically useful as CM. The frequencies of rehospitalisations and emergency visits did not differ between the groups. RM was found to be safe and effective in early detection and treatment of medical- and device-related events and in reducing hospital visits. Improved HRQoL was described not only immediately after PM implantation but also extended over a long time.

Long-Term Socioeconomic Impact of Informal Care Provided to Patients with Pacemakers: Remote vs. Conventional Monitoring.

The impact of informal care immediately after pacemaker (PM) implantation has been well established; however, not much is known about its long-term effects. The present study compared personal characteristics, associated problems, workloads, time, and costs related to informal care provided to patients with PM under remote monitoring (RM) vs. conventional monitoring (CM) in the hospital, five years after implantation. The PONIENTE study was a controlled, non-randomized or masked clinical trial conducted with information obtained from the perspective of informal caregivers. Data were collected at 12 and 60 months after PM implantation. The patients in the study were assigned to two different groups: remote monitoring (RM) and conventional monitoring (CM). The "Disability, personal autonomy, and dependency situations survey" (EDAD) was administered to collect information on sociodemographic characteristics, time, care difficulties, health status, professional aspects, and impact on economic, family, or leisure aspects of the main caregivers providing care to patients with pacemakers. After five years, 55 patients completed the study (RM = 21; CM = 34). The average age was 63.14 years (SD = 14.90), 96% of them were women, and the most predominant marital status was married (72%). Informal caregivers lived in the homes of the patients in 70% of cases, and 88% indicated that they had to provide care six to seven days a week. The average cost per patient during the monitoring period studied was 13.17% lower in the RM group than in the CM group, and these differences were not statistically significant (p = 0.35). This study found similar results in the two groups under study with respect to sociodemographic characteristics, workload, time, and problems associated with health, leisure and family members. The costs associated with care were higher in the CM group; however, these differences were not statistically significant.

Cost-utility analysis on telemonitoring of users with pacemakers: The PONIENTE study.

INTRODUCTION: Few studies have confirmed the cost-saving of telemonitoring of users with pacemakers (PMs). The purpose of this controlled, non-randomised, non-masked clinical trial was to perform an economic assessment of telemonitoring (TM) of users with PMs and check whether TM offers a cost-utility alternative to conventional follow-up in hospital. METHODS: Eighty-two patients implanted with an internet-based transmission PM were selected to receive either conventional follow-up in hospital ( n = 52) or TM ( n = 30) from their homes. The data were collected during 12 months while patients were being monitored. The economic assessment of the PONIENTE study was performed as per the perspectives of National Health Service (NHS) and patients. A cost-utility analysis was conducted to measure whether the TM of patients with PMs is cost-effective in terms of costs per gained quality-adjusted life years (QALYs). RESULTS: There was a significant cost-saving for participants in the TM group in comparison with the participants in the conventional follow-up group. From the NHS's perspective, the patients in the TM group gained 0.09 QALYs more than the patients in the conventional follow-up group over 12 months, with a cost saving of 57.64% (€46.51 versus €109.79, respectively; p < 0.001) per participant per year. In-office visits were reduced by 52.49% in the TM group. The costs related to the patient perspective were lower in the TM group than in the conventional follow-up group (€31.82 versus €73.48, respectively; p < 0.005). The costs per QALY were 61.68% higher in the in-office monitoring group. DISCUSSION: The cost-utility analysis performed in the PONIENTE study showed that the TM of users with PMs appears to be a significant cost-effective alternative to conventional follow-up in hospital.

Effectiveness of pacemaker tele-monitoring on quality of life, functional capacity, event detection and workload: The PONIENTE trial.

AIMS: The purpose of the present study was to assess the effectiveness of the remote monitoring (RM) of older adults with pacemakers on health-related quality of life, functional capacity, feasibility, reliability and safety. METHODS: The PONIENTE study is a controlled, non-randomized, non-blinded clinical trial, with data collection carried out during the pre-implant stage and after 12 months. Between October of 2012 and November of 2013, 82 patients were assigned to either a remote monitoring group (n = 30) or a conventional hospital monitoring (HM) group (n = 52). The EuroQol-5D (EQ-5D) and the Duke Activity Status Index were used to measure health-related quality of life and functional capacity, respectively. Baseline characteristics and number of hospital visits were also analyzed. RESULTS: The baseline characteristics of the two study groups were similar for both the EQ-5D (RM 0.74, HM 0.67; P = 0.404) and the Duke Activity Status Index (RM 21.42, HM 19.95; P = 0.272). At the 12-month follow up, the EQ-5D utility score was improved for both groups (RM 0.91, HM 0.81; P = 0.154), unlike the EQ-5D Visual Analog Scale (P = 0.043). The Duke Activity Status Index score was similar to the baseline score. The number of in-hospital visits was 27% lower (3 vs 4; P < 0.001) in the remote group as compared with the hospital group. CONCLUSIONS: The PONIENTE trial suggests that the remote monitoring of pacemakers in older adults is an equivalent option to hospital monitoring, in terms of health-related quality of life and functional capacity. Furthermore, it allows for the early detection of clinical and pacemaker-related adverse events, and significantly reduces the number of in-hospital visits. Geriatr Gerontol Int 2016; 16: 1188-1195.

Workload, time and costs of the informal cares in patients with tele-monitoring of pacemakers: the PONIENTE study.

OBJECTIVES: The purpose of this study was to assess the burden borne by and the costs to informal caregivers of patients with remotely monitored (RM) pacemakers. METHODS: The PONIENTE study was a controlled, non-randomised clinical trial, with data collected from informal caregivers, 12 months after implantation of pacemakers. The survey on disabilities, personal autonomy, and dependency situations was used to gather information on demographic and social characteristics, levels of professionalism, time and types of care, difficulties in providing care, health status, professional aspects, economic and family or leisure impacts due to informal caregiving for patients with pacemakers. RESULTS: During 14 months, 76 caregivers were enrolled in the PONIENTE trial. Of which, 26 were included in the RM group and 50 in the hospital-monitored group (HM). The mean ages were 58.62 ± 16.51 and 61.10 ± 12.67 years, respectively (p = 0.56) in the groups, and 69.7 % were females. The majority (96.1 %) of the caregivers declared that they had to provide their services between 6 and 7 days per week (88.5 % in RM group versus 100 % in HM group; p = 0.037). The costs related to care provided by the informal caregivers were 21.38 % lower in the RM group than in the HM group (p = 0.033). CONCLUSIONS: The PONIENTE study shows a significant impact of informal care on relatives and friends of patients with pacemakers in terms of their well-being and costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT02234245.

A Systematic Review of Economic Evaluations of Pacemaker Telemonitoring Systems.

INTRODUCTION AND OBJECTIVES: Over the last decade, telemedicine applied to pacemaker monitoring has undergone extraordinary growth. It is not known if telemonitoring is more or less efficient than conventional monitoring. The aim of this study was to carry out a systematic review analyzing the available evidence on resource use and health outcomes in both follow-up modalities. METHODS: We searched 11 databases and included studies published up until November 2014. The inclusion criteria were: a) experimental or observational design; b) studies based on complete economic evaluations; c) patients with pacemakers, and d) telemonitoring compared with conventional hospital monitoring. RESULTS: Seven studies met the inclusion criteria, providing information on 2852 patients, with a mean age of 81 years. The main indication for device implantation was atrioventricular block. With telemonitoring, cardiovascular events were detected and treated 2 months earlier than with conventional monitoring, thus reducing length of hospital stay by 34% and reducing routine and emergency hospital visits as well. There were no significant intergroup differences in perceived quality of life or number of adverse events. The cost of telemonitoring was 60% lower than that of conventional hospital monitoring. CONCLUSIONS: Compared with conventional monitoring, cardiovascular events were detected earlier and the number or hospitalizations and hospital visits was reduced with pacemaker telemonitoring. In addition, the costs associated with follow-up were lower with telemonitoring.

[Comparative Effectiveness of Remote Monitoring of People with Cardiac Pacemaker versus Conventional: quality of Life at the 6 Months]. / Efectividad comparativa del seguimiento remoto a personas con marcapasos cardíacos frente al convencional: calidad de vida a los 6 meses.

BACKGROUND: The use of remote follow-up (RF) of people with pacemakers (PM) is limited in comparison to the hospital modality (HS), being still poor the scientific evidence that shows their comparative effectiveness. The aim of this study was to compare the quality of life in individuals with different modalities of follow-up. METHODS: Controlled, not randomized nor masked clinical trial, with data collection at pre and post-implantation of pacemakers during the 6 months follow-up. All patients over 18 years-old who were implanted a PM during the study period were selected (n = 83), and they were assigned to RF (n = 30) or HF (n = 53) groups according to their personal characteristics and patient's preferences. Baseline characteristics and number of visits to the hospital were analysed, the EuroQol-5D (EQ5D) questionnaire was administered to evaluate the health-related quality of life, and Duke Activity Status Index (DASI) to assess the functional capacity. RESULTS: There were no significant differences between both groups in relation to the baseline analysis, EQ5D (RF:0.7299; HF:0.6769) and DASI (RF:21.41; HF:19.99). At 6 months the quality of life was improved in both groups (EQ5D RF:0.8613; HF:0.8175; p = 0,439) still without significant differences between them. DASI score was similar to baseline (20.51 vs 21.80). RF group performed less transmissions/visits per patient (1.57) than hospital group (1.96; relative reduction 31%; p = 0.015). CONCLUSIONS: Remote follow-up of people with pacemakers might be considered as an equivalent option to the hospital follow-up in relation to the quality of life and it reduces the number of hospital visits.

Revisión sistemática de evaluaciones económicas de los sistemas de telemonitorización en los marcapasos / A systematic review of economic evaluations of pacemaker telemonitoring systems

Introducción y objetivos: En la última década, la telemedicina aplicada a la monitorización de marcapasos cardiacos ha experimentado un extraordinario crecimiento. Se desconoce si esta tecnología tiene una eficiencia diferente de la convencional. El objetivo del estudio es realizar una revisión sistemática analizando la evidencia disponible con respecto al consumo de recursos y los resultados en salud en ambas modalidades de seguimiento. Métodos: La búsqueda se realizó en 11 bases de datos y se incluyeron estudios publicados hasta noviembre de 2014. Los criterios de inclusión fueron: a) diseño experimental u observacional; b) estudios basados en evaluaciones económicas completas; c) pacientes con marcapasos, y d) telemonitorización comparada con la modalidad hospitalaria. Resultados: Siete estudios cumplían los criterios de inclusión, con información sobre 2.852 pacientes con una media de edad de 81 años; el bloqueo auriculoventricular era la principal indicación. En la telemonitorización, los eventos cardiovasculares se detectan y tratan 2 meses antes, con lo que se reduce en un 34% el número de hospitalizaciones, así como las visitas rutinarias y de urgencias al hospital. No hubo diferencias intergrupales significativas en calidad de vida percibida o número de eventos adversos. El coste de la telemonitorización es un 60% menor que el de la monitorización hospitalaria. Conclusiones: En la telemonitorización de marcapasos, los eventos cardiovasculares se detectan antes y disminuyen las hospitalizaciones y el número de visitas al hospital. Además, con la telemonitorización se reducen los costes asociados al seguimiento (AU)

Introduction and objectives: Over the last decade, telemedicine applied to pacemaker monitoring has undergone extraordinary growth. It is not known if telemonitoring is more or less efficient than conventional monitoring. The aim of this study was to carry out a systematic review analyzing the available evidence on resource use and health outcomes in both follow-up modalities. Methods: We searched 11 databases and included studies published up until November 2014. The inclusion criteria were: a) experimental or observational design; b) studies based on complete economic evaluations; c) patients with pacemakers, and d) telemonitoring compared with conventional hospital monitoring. Results: Seven studies met the inclusion criteria, providing information on 2852 patients, with a mean age of 81 years. The main indication for device implantation was atrioventricular block. With telemonitoring, cardiovascular events were detected and treated 2 months earlier than with conventional monitoring, thus reducing length of hospital stay by 34% and reducing routine and emergency hospital visits as well. There were no significant intergroup differences in perceived quality of life or number of adverse events. The cost of telemonitoring was 60% lower than that of conventional hospital monitoring. Conclusions: Compared with conventional monitoring, cardiovascular events were detected earlier and the number or hospitalizations and hospital visits was reduced with pacemaker telemonitoring. In addition, the costs associated with follow-up were lower with telemonitoring (AU)

Efectividad comparativa del seguimiento remoto a personas con marcapasos cardíacos frente al convencional: calidad de vida a los 6 meses / Comparative effectiveness of remote monitoring of people with cardiac pacemaker versus conventional: quality of life at the 6 months

Fundamentos: El uso del seguimiento remoto (SR) de personas portadoras de marcapasos (MP) es limitado en comparación con la modalidad hospitalaria (SH), siendo escasa la evidencia científica que muestre su efectividad. El objetivo de este estudio fue comparar la calidad de vida en personas con diferentes modalidades de seguimiento. Métodos: Ensayo clínico controlado, no aleatorizado ni enmascarado, con recogida de datos pre y post-implante del marcapasos durante los 6 meses de seguimiento. Se seleccionó a todos los pacientes mayores de 18 años a los que se les implantó un marcapasos en el periodo de estudio (n=83), siendo asignados al grupo SR (n=30) o al grupo SH (n=53), en función de sus características personales y preferencias. Se analizaron las características basales y número de visitas al hospital, y se administró el cuestionario EuroQol-5D (EQ-5D) para evaluar la calidad de vida relacionada con la salud y el Duke Activity Status Index (DASI) para valorar la capacidad funcional. Resultados: No hubo diferencias significativas entre ambos grupos en relación al análisis basal, EQ-5D (SR:0,7299; SH:0,6769) y DASI (SR:21,41; SH:19,99) iniciales. A los 6 meses la calidad de vida mejoró en ambos grupos (SR:0,8613; SH:0,8175; p=0,439) aun sin diferencias estadísticamente significativas entre ellos. La puntuación final en el DASI fue similar a la basal (20,51 vs 21,80). El grupo de SR realizó menos visitas/transmisiones por paciente (1,57) que el grupo hospitalario (1,96), la reducción relativa fue del 31% (p=0,015). Conclusiones: El seguimiento remoto de personas portadoras de marcapasos se podría considerar como una opción equivalente al hospitalario en relación a la calidad de vida y reduce el número de visitas al hospital (AU)

Background: The use of remote follow-up (RF) of people with pacemakers (PM) is limited in comparison to the hospital modality (HS), being still poor the scientific evidence that shows their comparative effectiveness. The aim of this study was to compare the quality of life in individuals with different modalities of follow-up. Methods: Controlled, not randomized nor masked clinical trial, with data collection at pre and post-implantation of pacemakers during the 6 months follow-up. All patients over 18 years-old who were implanted a PM during the study period were selected (n=83), and they were assigned to RF (n=30) or HF (n=53) groups according to their personal characteristics and patient’s preferences. Baseline characteristics and number of visits to the hospital were analysed, the EuroQol-5D (EQ5D) questionnaire was administered to evaluate the health-related quality of life, and Duke Activity Status Index (DASI) to assess the functional capacity. Results: There were no significant differences between both groups in relation to the baseline analysis, EQ5D (RF:0.7299; HF:0.6769) and DASI (RF:21.41; HF:19.99). At 6 months the quality of life was improved in both groups (EQ5D RF:0.8613; HF:0.8175; p=0,439) still without significant differences between them. DASI score was similar to baseline (20.51 vs 21.80). RF group performed less transmissions/visits per patient (1.57) than hospital group (1.96; relative reduction 31%; p=0.015). Conclusions: Remote follow-up of people with pacemakers might be considered as an equivalent option to the hospital follow-up in relation to the quality of life and it reduces the number of hospital visits (AU)