Quality of life of patients with cardiac pacemaker: levels, associated characteristics, and the impact of anxiety and depression.

INTRODUCTION: Implantation of a permanent cardiac pacemaker (PPM) improves recipients' quality of life (QoL). However, psychiatric disturbance may adversely affect QoL and undermine clinical outcomes.

Periprocedural complications of cardiac implantable electronic device implantation in very elderly patients with cognitive impairment: A prospective study.

ABSTRACT: Very elderly people (over 80 years) with cardiac implantable electronic devices (CIEDs) indications often have a higher prevalence of aging comorbidity, among which cognitive impairment is not uncommon. This study aimed to investigate periprocedural complications of CIED implantation among very elderly patients with and without cognitive impairment. One hundred eighty patients ≥80 years of age indicated for CIED implantation were included in our study. During hospitalization, the cognitive evaluation was performed according to the Diagnostic and Statistical Manual of Mental Disorders (fifth edition). According to the cognitive test results, patients were divided into 2 groups (90 patients with normal cognitive function and 90 patients with cognitive impairment). Meanwhile, their physical parameters and laboratory measurements were completed. The procedural data and periprocedural complications were collected from both groups. The association between cognitive impairment and periprocedural complications was analyzed using univariate and multiple logistic regression analyses. During a one-month follow-up, the most frequent periprocedural complications in very elderly patients were pocket hematoma and thrombosis events. Cognitively impaired patients had a higher incidence of complications than normal cognitive patients. Multivariate regression analysis showed that cognitive impairment was positively correlated with periprocedural complications in very elderly patients. Cognitive impairment is associated with increased periprocedural complications of CIED implantation in very elderly patients.

Sport activity in patients with cardiac implantable electronic devices: evidence and perspectives.

Demographic characteristics of patients with cardiac implantable electronic devices have significantly changed during the last few years, according to the ageing of the population and the consequent increase in the number of elderly individuals with indication for pacemaker implant and, on the other hand, to the increased number of young individuals implanted with an implantable cardioverter defibrillator for the primary prevention of sudden death. More and more often, both elderly and young patients ask the physician to deal with the device in their daily activities, which often include sport practice. This latter is advisable because of its recognized benefits on cardiovascular prevention, although there are many limitations for patients with a cardiac implantable electronic device. Hence, the need to balance the patient's request with the appropriate precautions emerging from existing evidence. The current article aims to provide an overview of the most recent data on this topic, derived from registries and observational studies. Over the years an attempt to standardize recommendations has been made, but robust evidence is still lacking. Substantial differences exist between countries based on their sports regulations. Official recommendations of European and American Scientific Societies are resumed. The future perspective is to obtain data to allow these patients a safer practice of sport activity also through technological advances in terms of device materials and programming improvement and the possibility of remote monitoring.

Comparison of depression and anxiety among pacemaker and implantable cardioverter-defibrillator recipients: A cross-sectional study.

INTRODUCTION: Anxiety and depression among implantable cardioverter-defibrillator (ICD) recipients can lead to physical or psychological consequences and reduce the quality of life of these patients. Few studies have compared the frequency and severity of depressive and anxiety disorders in the pacemaker (PM) and ICD recipients. The aim of the present study was to compare depression and anxiety among PM and ICD recipients. METHODS: This cross-sectional study was performed on 296 patients referred to a specialized cardiology teaching hospital from October 1, 2019 to July 1, 2020. Patients were selected using convenience sampling method. RESULTS: Regarding anxiety, the results showed that the overall prevalence of anxiety in PM, ICD, and control groups was 23.5%, 28%, and 8%, respectively. Results showed no significant difference between PM and ICD recipients regarding the anxiety prevalence (p = .46). With regard to depression, the results showed that the overall prevalence of depression in the PM, ICD, and control groups was 7.1%, 23%, and 4.1%, respectively. The results showed a significant difference between PM and ICD recipients in terms of depression prevalence (p = .03). The results also showed that the prevalence of depression was significantly higher among PM and ICD recipients than the control group (p = .01). CONCLUSION: Considering the results of the present study and the high prevalence of anxiety and depression, it seems necessary to focus more on educating patients about the effectiveness of PM and ICD devices in reducing anxiety and depression.

Quality of life and psychological co-morbidities in children and adolescents with cardiac pacemakers and implanted defibrillators: a cohort study in Eastern Germany.

INTRODUCTION: The implantation of a pacemaker or an implantable cardioverter-defibrillator during childhood may reduce quality of life and lead to mental health problems. This study aimed to evaluate potential mental health problems (i.e., depressive and anxiety symptoms) and quality of life in children with cardiac active devices in comparison to healthy peers. METHODS: We analysed data of children with pacemakers or implantable cardioverter-defibrillators aged 6-18 years. Quality of life, depressive and anxiety symptoms were assessed by standardised questionnaires. The results were compared to age-matched reference groups. RESULTS: Children with implantable cardioverter-defibrillator showed significant lower quality of life in comparison to reference group (p = 0.03), but there was no difference in quality of life between children with pacemaker and reference group. There was no significant difference in depressive symptoms between children with a cardiac rhythm device compared to reference group (self-report: p = 0.67; proxy report: p = 0.49). There was no significant difference in anxiety (p = 0.53) and depressive symptoms (p = 0.86) between children with pacemaker and children with implantable cardioverter-defibrillator. CONCLUSIONS: Living with an implantable cardioverter-defibrillator in childhood seems to decrease the patients' quality of life. Although children with pacemaker and implantable cardioverter-defibrillator don't seem to show more depressive and anxiety symptoms in comparison to their healthy peers, there still can be an increased risk for those children to develop mental health problems. Therefore, treating physicians should be aware of potential mental health problems and provide the patients and their families with appropriate therapeutic offers.

The Effect of Religious Intervention Using Prayer for Quality of Life and Psychological Status of Patients with Permanent Pacemaker.

The development of heart disease, followed by the pacemaker implantation, has reduced the quality and psychological problems for patients. Thus, the present study was conducted to determine the effect of prayer on the quality of life and the psychological status of patients with permanent pacemaker. This is a quasi-experimental study in which 75 patients were assigned to experimental and control groups. Religious intervention was conducted for the experimental group, including the Tavasol prayer and four recommended (mustahab) remembrances in 7 sessions. Before and after the intervention, the patients were provided with the quality of life questionnaire and psychological status. Then, the questionnaires were analyzed using descriptive and analytical tests. Before intervention, there was no difference between quality of life status and psychological status of patients, but after intervention, their quality of life increased and their psychological status improved significantly. The implementation of religious intervention based on prayer positively affects the quality of life and psychological status of patients; thus, implementing this intervention is necessary for patients.

The gap between what patients know and desire to learn about their cardiac implantable electronic devices.

BACKGROUND: Advancement of digital technology now allows patients to have access to data from their cardiac implantable electronic devices (CIEDs). However, patients' understanding regarding CIED data and perceived personal usability remain unclear. The present study is a prospective survey to examine patients' understanding of their CIEDs and their perception of what is important. METHODS: We screened 400 patients between July and December 2018 who presented to our outpatient clinic for a CIED interrogation. Patients received a one-page questionnaire asking baseline demographics, their perception about their own knowledge about their device, and multiple-choice questions in seven basic categories: type of CIED, original indication, functionality, manufacturer, number of active leads, estimated battery life, and number of shocks received. We compared these answers to their interrogation reports to assess accuracy. We also asked participants what they would like to be aware of regarding their CIED. RESULTS: From this cohort, 344 of 400 (86%) (62.9 ± 12.8 years and 64 % males) agreed to take the survey and were included in the analysis. At baseline, 63.2% agreed or strongly agreed that they were knowledgeable about their devices. The overwhelming majority of patients demonstrated CIED knowledge deficits in at least one content area (n = 294, 86%), or more than two content areas (n = 176, 51%). Patients agreed or strongly agreed that they had a desire to have information regarding each of the following: battery life (84%), activity level (79%), heart rate trend (75%), and ventricular arrhythmias (74%). CONCLUSION: There is a large discrepancy in patients' level of knowledge regarding their CIEDs and their wish to know more details. Future technologies should satisfy providers' goals to educate their patients with basic information and fulfill patients' desire to obtain more data from their CIEDs.

Health-related quality of life outcomes in pediatric patients with cardiac rhythm devices: a cross-sectional study with case-control comparison.

BACKGROUND: Little is known about health-related quality of life (HRQoL) in pediatric patients with cardiac rhythm devices. This study aims to compare self- and proxy-reported HRQoL in patients with pacemaker (PM) and implantable cardioverter-defibrillator (ICD) to that in sex- and age-matched healthy controls and to examine predictors for generic and disease-specific HRQoL. METHODS: The study included 72 PM and ICD patients (39% females) and 72 sex- and age-matched healthy controls from 3 to 18 years of age. HRQoL data was obtained by the PedsQL 4.0 Generic Core Scales and Pediatric Cardiac Quality of Life Inventory. Medical data was collected retrospectively from medical records. RESULTS: Patients had significantly lower self- and proxy-reported generic overall HRQoL and lower physical health than healthy controls, and ICD patients also had lower psychosocial health. On multivariate analyses, generic overall HRQoL and physical health was significantly predicted by current cardiac medication (ß = -.39, p = .02 for overall HRQoL, respectively ß = -.44, p = .006 for physical health). Disease-specific overall HRQoL was only marginally predicted by child age, device type, and the presence of a structural congenital heart disease (p < .10). CONCLUSIONS: This study shows that PM and ICD patients have lower HRQoL than healthy controls and that patients who need cardiac medication are seen by their parents at great risk for lower generic overall HRQoL. Our study also indicates a trend towards higher risk for low disease-specific HRQoL in younger patients, ICD patients, and patients with a structural congenital heart disease. Special attention should be given to these patients as they may benefit from a timely clinical evaluation in order to provide supportive interventions.

Patients' experiences of remote communication after pacemaker implant: The NORDLAND study.

BACKGROUND: The concept of 'patient experience' has become central to how to improve healthcare. Remote communication with patients is today a frequent practice in healthcare services, showing similar outcomes to standard outpatient care while enabling cost reduction in both formal and informal care. The purpose of this study was to analyse the experiences of people with telemonitoring pacemakers. METHODS: Patients were randomly allocated to either the telemonitoring or hospital monitoring follow-ups. Using the 'Generic Short Patient Experiences Questionnaire' (GS-PEQ), as well as an ad-hoc survey from the 'telehealth patient satisfaction survey' and 'costs survey', patients' experiences were measured six months after the pacemaker implant in a cohort of 50 consecutive patients. The mean age was 74.8 (± 11.75) years and 26 (52%) patients were male of which 1 was lost in follow-up. Finally, 24 patients were followed up with standard hospital monitoring, while 25 used the telemonitoring system. Differences in baseline characteristics between groups were not found. RESULTS: Findings showed overall positive and similar experiences in patients living with telemonitoring and hospital monitoring pacemakers. Significant differences were found in GS-PEQ concerning how telemonitoring patients received less information about their diagnosis/afflictions (p = 0.046). We did not find significant differences in other items such as 'confidence in the clinicians' professional skills', 'treatment perception adapted to their situation', 'involvement in decisions regarding the treatment', 'perception of hospital organisation', 'waiting before admission', 'satisfaction of help and treatment received', 'benefit received', and 'incorrect treatment'. CONCLUSIONS: The remote communication of pacemakers was met with positive levels of patients' experiences similarly to patients in the hospital monitoring follow-up. However, telemonitoring patients received less information. Thus, improving the quality and timing of information is required in telemonitoring patients in the planning and organisation of future remote communication healthcare services for people living with a pacemaker implant.

Posttraumatic stress and health-related quality of life in parents of children with cardiac rhythm devices.

PURPOSE: Studies have shown a high prevalence of post-traumatic stress disorders (PTSD) among parents of children with life-threatening diseases. However, it is yet unknown whether parents of children with cardiac rhythm device develop posttraumatic stress symptoms or even PTSD. METHODS: This cross-sectional investigation is part of a comprehensive single-center study of long-term medical and psychosocial outcomes in pediatric patients with pacemaker (PM) and implantable cardioverter defibrillator (ICD). 69 patients (78%) were included in the study, with the participation of 69 mothers and 57 fathers. Parents completed the Posttraumatic Diagnostic Scale and Medical Outcomes Study Short Form-36 item questionnaire. Child's medical data was collected retrospectively from patients' hospital records. RESULTS: At assessment, the patients (39% females) were on average 11.2 years old. The predominant device type was PM in 56 cases (81%). The mean time since device implantation was 6.3 years (SD = 4.3). Full heart-disease related PTSD was diagnosed in one mother and no father, while partial heart-disease-related PTSD was diagnosed in 3 mothers (4%) and 2 fathers (4%). Parental HRQoL-especially regarding the mental health dimension-was affected in both parents. In both parents, total PTSD symptom severity scores were a significant predictor for mental health summary scores after controlling for child age at implantation, presence of other non-cardiac disease in the child, parental age, and presence of own chronic disease. CONCLUSIONS: Special attention should be given to parental PTSD symptoms in the clinical follow-up of PM and ICD patients as some parents might probably benefit from psychological support.

Cross-cultural adaptation and validation of the Indonesian version of AQUAREL on patients with permanent pacemaker: a cross-sectional study.

OBJECTIVE: The assessment of quality of life has significant impact in device therapy. This research was aimed to translate and evaluate the validity and reliability of the Indonesian version of the AQUAREL questionnaire. RESULTS: We evaluated 32 patients during the cross-cultural adaptation stage and 20 patients during validity and reliability evaluation stages. Indonesian version of AQUAREL showed positive correlation between 6-min walking test and dyspnea domain (r = 0.228; p = 0.048), and showed negative correlation between NT pro-BNP and chest discomfort (r = - 0.231; p = 0.043) and dyspnea domain (r = - 0.268; p = 0.020). The total AQUAREL also showed positive moderate correlation toward total SF-36 (r = 0.543; p = 0.000). The internal consistency was good (Cronbach α = 0.728) and the repeatability between day 1 and day 8 was good, with moderate positive correlation (r = 0.581; p = 0.007).

Obstructive sleep apnea and quality of life in elderly patients with a pacemaker.

OBJECTIVE: To evaluate quality of life in elderly patients with obstructive sleep apnea (OSA) who have a pacemaker. METHODS: This was a cross-sectional study involving elderly patients (≥ 60 years of age) with a pacemaker. The dependent variable was quality of life, as evaluated with the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). Sociodemographic and clinical parameters, including anxiety and depression (Hospital Anxiety and Depression Scale score), as well as the presence of OSA (defined as an apnea-hypopnea index ≥ 15 events/h), were analyzed as independent variables. Patients with cognitive/neurological deficits or decompensated heart failure were excluded. RESULTS: We evaluated 72 patients, 17 (23.6%) of whom presented OSA. Of those 17 patients, 9 (52.9%) were male. The mean age was 72.3 ± 9.3 years. A diagnosis of OSA was not associated with gender (p = 0.132), age (p = 0.294), or body mass index (p = 0.790). There were no differences between the patients with OSA and those without, in terms of the SF-36 domain scores. Fourteen patients (19.4%) presented moderate or severe anxiety. Of those 14 patients, only 3 (21.4%) had OSA (p = 0.89 vs. no OSA). Twelve patients (16.6%) had moderate or severe depression. Of those 12 patients, only 2 (16.6%) had OSA (p = 0.73 vs. no OSA). CONCLUSIONS: In elderly patients with a pacemaker, OSA was not found to be associated with quality of life or with symptoms of anxiety or depression.

Effect of peer support on health outcomes in patients with cardiac pacemaker implantation: A randomized, controlled trial.

The aim of this study was to examine the effect of a nurse-led telephone-based peer support program on health outcomes in patients after cardiac pacemaker implantation. Seventy six patients who received cardiac pacemaker implantation were recruited as participants and randomly assigned to either the peer support group or the usual care group. The usual care group received routine care and health education measures provided by nurses; the peer support group received telephone-based peer support. Health-related quality of life, self-care knowledge-attitudes-practice, postoperative anxiety and depression, compliance with attending scheduled follow-up visits, and the incidence of postoperative complications were evaluated at baseline and 6 months' postintervention for the two groups. The result showed that the interventions had a better effect on self-care knowledge-attitudes-practice, postoperative anxiety and depression, and compliance with attending scheduled follow-up visits in the peer support group than in the usual care group. This study confirms that telephone-based peer support improves self-care ability, compliance with attending scheduled follow-up visits, and reduces postoperative anxiety and depression more effectively than conventional nurse care among patients with cardiac pacemaker implantation.

The influence of age on the psychological profile of patients with cardiac implantable electronic devices: results from the Italian population in a multicenter study conducted by the European Heart Rhythm Association.

BACKGROUND: Cardiac implantable electronic devices (CIEDs) are widely used to treat bradyarrhythmias or improve the prognosis of patients with heart failure (HF). AIMS: To evaluate age-related (≤ 75 vs. > 75 years) attitudes, worries, psychological effects and needs in an Italian CIEDs population. METHODS: Patients attending their periodical ambulatory evaluation received a questionnaire conceived by the European Heart Rhythm Association Scientific Initiatives Committee as part of a multicenter, multinational snapshot survey. Seven countries participated in the study, and 1646 replies were collected. Of these, 437 (27%) were from Italy. Present results refer to the Italian population only. CIEDs were stratified into devices to treat bradycardia or HF. RESULTS: The use of CIEDs was more common in advanced age. Older patients needed less information about CIEDs than younger ones (p = 0.044), who would prefer to be better informed about CIEDs-related consequences on psychologic profile (p = 0.045), physical (p < 0.001) and sexual (p < 0.001) activities, and driving limitations (p = 0.003). When compared to older subjects, younger individuals experienced more difficulties (p = 0.035), especially in their professional (p < 0.001) and private life (p = 0.033), feeling their existence was limited by the device (p < 0.001). Conversely, quality of life (HRQL) more often improved in the elderly (p = 0.001). Information about what to do with CIEDs at the end of life is scant independently of age. CONCLUSIONS: HRQL after CIEDs implantation improves more frequently in older patients, while the psychological burden of CIEDs is usually higher in younger patients. End of life issues are seldom discussed.

Health-Related Quality of Life and Psychological Adjustment of Children and Adolescents with Pacemakers and Implantable Cardioverter Defibrillators: A Systematic Review.

The absence of cardiac symptoms, the improved exercise tolerance and the increased life expectancy are the advantages of a successful cardiac device therapy. Nevertheless, the fact of a lifelong device dependency, the inherent possibility of device malfunction and the progression of the underlying heart disease may impact the health-related quality of life (HRQoL) and the psychological adjustment of these individuals. To date, an overview of findings on these topics is lacking. The objective of this study was to evaluate and summarize the current evidence on generic and disease-specific HRQoL and psychological adjustment in paediatric patients with a pacemaker (PM) or an implantable cardioverter defibrillator (ICD). A systematic literature search was conducted using relevant databases and predefined keywords. Study selection was conducted based on predefined inclusion criteria. Fourteen studies were selected which were of varying methodological quality. Overall, the studies indicated that PM/ICD patients themselves and their parents scored lower than healthy controls on generic HRQoL scales and reported similar disease-related HRQoL as patients with severe forms of congenital heart disease. Regarding psychological adjustment outcome, PM recipients and norms were not significantly different with respect to anxiety and depression symptoms, while ICD patients showed more signs of anxiety than depression. HRQoL and psychological health should be considered when setting therapy goals and evaluating medical treatment success. This approach allows an early intervention in patients at risk of maladaptation, which is especially important in the young patient undergoing crucial developmental stages.

Cognitive behavioral intervention improves quality of life and perceived illness acceptance in patients after cardiac electrotherapy devices implantation. / Interwencja poznawczo-behawioralna poprawia jakosc zycia oraz akceptacje choroby wsród pacjentów po implantacji urzadzen do elektroterapii serca.

OBJECTIVES: This study is an attempt to provide an analysis of the influence of implementation of cognitive behavioral intervention (CBI) in patients after cardiovascular implantable electronic device (CIED) implantation on the quality of life following the procedure as well as the level of illness acceptance. METHODS: The study group consisted of patients who underwent standard medical care related to CIED implantation and who additionally received CBI. Patients who received only standard medical care related to CIED implantation constituted a control group. CBI consisted of four sessions conducted over 30 (±3) days after the implantation. Demographic, clinicaland psychological factors were assessed.The Acceptance of Illness Scale (AIS) and EuroQol-5D (EQ-5D) were applied. RESULTS: In total, 128 patients (women: 36.7%, mean age 64.5 ± 8.9) were included in the study. The proposed cycle of four structured CBI meetings was well accepted by the patients, which is confirmed by their high turnout for these meetings. After six months, quality of life indices were significantly improved in cardiac electrotherapy recipients assigned to CBI, including: Visual Analogue Scale EQ-5D (80.2 ± 11.8 vs. 64.9 ± 14.3; p < 0.0001) and better acceptance of illness (AIS: 35.6 ± 4.3 vs. 28.7 ± 6.1; p < 0.0001). CONCLUSIONS: Implementation of CBI in patients after CIED implantation significantly improved indices of quality of life as well as illness acceptance, when compared to the control group of patients in standard care following electrotherapy. CBI showed multiple benefits in this population, as well as ensures the fulfilment of its expected therapeutic effect, while short duration of the intervention did not prolong the hospitalization itself.

Obstructive sleep apnea and quality of life in elderly patients with a pacemaker / Apneia obstrutiva do sono e qualidade de vida em idosos portadores de marca-passo

ABSTRACT Objective: To evaluate quality of life in elderly patients with obstructive sleep apnea (OSA) who have a pacemaker. Methods: This was a cross-sectional study involving elderly patients (≥ 60 years of age) with a pacemaker. The dependent variable was quality of life, as evaluated with the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). Sociodemographic and clinical parameters, including anxiety and depression (Hospital Anxiety and Depression Scale score), as well as the presence of OSA (defined as an apnea-hypopnea index ≥ 15 events/h), were analyzed as independent variables. Patients with cognitive/neurological deficits or decompensated heart failure were excluded. Results: We evaluated 72 patients, 17 (23.6%) of whom presented OSA. Of those 17 patients, 9 (52.9%) were male. The mean age was 72.3 ± 9.3 years. A diagnosis of OSA was not associated with gender (p = 0.132), age (p = 0.294), or body mass index (p = 0.790). There were no differences between the patients with OSA and those without, in terms of the SF-36 domain scores. Fourteen patients (19.4%) presented moderate or severe anxiety. Of those 14 patients, only 3 (21.4%) had OSA (p = 0.89 vs. no OSA). Twelve patients (16.6%) had moderate or severe depression. Of those 12 patients, only 2 (16.6%) had OSA (p = 0.73 vs. no OSA). Conclusions: In elderly patients with a pacemaker, OSA was not found to be associated with quality of life or with symptoms of anxiety or depression.

RESUMO Objetivo: Avaliar a qualidade de vida em idosos portadores de marca-passo e apneia obstrutiva do sono (AOS). Métodos: Estudo de corte transversal com idosos (idade ≥ 60 anos) portadores de marca-passo cardíaco. A variável dependente foi qualidade de vida, avaliada por meio do Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). Dados sociodemográficos e clínicos foram analisados como variáveis independentes, entre os quais ansiedade e depressão (por meio da Hospital Anxiety and Depression Scale), assim como presença de AOS (definida como um índice de apneia-hipopneia ≥ 15 eventos/h). Pacientes com déficits cognitivos/neurológicos ou descompensação cardíaca foram excluídos. Resultados: A amostra foi composta por 72 pacientes, 17 dos quais (23,6%) apresentaram AOS - 9 homens (52,9%). A média de idade foi de 72,3 ± 9,3 anos. Não houve associações de presença de AOS com sexo (p = 0,132), idade (p = 0,294) e índice de massa corpórea (p = 0,790). Não foram observadas diferenças dos domínios do SF-36 entre os grupos com e sem AOS. Em relação à ansiedade, 14 pacientes (19,4%) apresentaram sintomas moderados ou graves, dos quais apenas 3 (21,4%) tinham AOS (p = 0,89 vs. sem AOS). No tocante à depressão, 12 pacientes (16,6%) apresentaram sintomas moderados ou graves, dos quais 2 (16,6%) tinham AOS (p = 0,73 vs. sem AOS). Conclusões: Nesta amostra em idosos portadores de marca-passo, a presença de AOS não foi associada a qualidade de vida e sintomas de ansiedade e depressão.

Health-related quality of life on tele-monitoring for users with pacemakers 6 months after implant: the NORDLAND study, a randomized trial.

BACKGROUND: With an ageing population and widening indications for pacemakers implantation, the number of persons carrying an implant is steadily increasing. The routine follow-up is thus a heavy burden for the respective NHS as well as for the patients and their relatives. Most of them of the studies have been performed in densely populated areas and nearby to the hospital. It is thus unknown whether these results could be applied also in rural areas such as Northern Norway with a more scattered population. The aim of this study was to assess the effectiveness of tele-monitoring (TM) in patients with pacemakers regarding reliability, safety and health-related quality of life, compared to traditional follow-up in outpatient clinic in a setting where geographical effects could possible influence the results. METHODS: The NORDLAND study is a controlled, randomized, non-masked clinical trial in pacemaker patients, with data collection carried out during the pre-implant stage and after 6 months. Between August of 2014 and November of 2015, 50 patients were assigned to either a tele-monitoring group (n = 25) or a conventional hospital monitoring (HM) group (n = 25). The EuroQol-5D (EQ-5D) utilities and visual analogue scale (VAS) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) were used to measure Health-Related Quality of Life. Baseline characteristics and number of hospital visits were also analyzed. RESULTS: The baseline characteristics of the two study groups were similar for EQ-5D utilities (TM:0.81; HM:0.76; p = 0.47), EQ-5D VAS (TM: 64.00; HM:64.88; p = 0.86) and the MLHFQ (TM:20.20; HM:28.96; p = 0.07). At the 6 month follow-up, there were no significant differences between the groups in EQ-5D utilities (TM: 0.81; HM: 0.76; p = 0.54) and EQ-5D VAS scores (TM: 72.71; HM: 59.79; p = 0.08). The MLHFQ score was improved in both groups (TM: -4.40; HM: -15.13; p <  0.001). The number of in-office visits was similar in both groups (TM: 1.24 vs HM: 1.12; P = 0.30). CONCLUSIONS: The NORDLAND trial shows that HRQoL is improved after implant in both groups. Without significant differences with regards to effectiveness and safety. In addition, provides a scientifically rigorous method to the field of HRQoL evaluations in patients with pacemakers. TRIAL REGISTRATION: ClinicalTrials.gov NCT02237404 , September 11, 2014.

Influence of frailty on the quality of life patients qualified for pacemaker implantation.

AIMS AND OBJECTIVES: An important question is whether frailty syndrome affects the assessment of quality of life or whether frailty syndrome may reduce the benefits of a cardiac pacemaker implantation. BACKGROUND: Frailty syndrome is known risk factor for quality of life evaluation after selected cardiology invasive procedures. DESIGN: The study was designed as single-centre prospective study. METHODS: The study included 171 patients aged ≥60 years who were qualified for pacemaker implantation. Quality of life was evaluated twice-before and 6 months after implantation using MLHF questionnaire. A frailty syndrome evaluation using the Tilburg Frailty Indicator (TFI) was performed prior to pacemaker implantation. A DDDR pacemaker was implanted in each patient. RESULTS: Frailty syndrome was identified in half of the patients with indications for cardiac pacemaker implantation. There was an improvement in quality of life in the six months after pacemaker implantation in all of the robust and frailty syndrome-affected patients that were included into the study-in general, physical and emotional domains. CONCLUSION: Implantation of cardiac pacemaker influences the compensation quality of life evaluation in patients with sinus node dysfunction. Presence of frailty influences worse quality of life of patients when evaluated before cardiac pacemaker implantation. RELEVANCE TO CLINICAL PRACTICE: Frailty should be evaluated in all older patients qualified for pacemaker implantation to evaluate high-risk group, optimise therapeutic approach and to intense education activities for patients and family.