The Influence of Hybrid Comprehensive Telerehabilitation on Anxiety in Heart Failure Patients: The TELEREH-HF Randomized Clinical Trial.

Telerehabilitation for heart failure (HF) patients is beneficial for physical functioning, prognosis, and psychological status. The study aimed at evaluating the influence of hybrid comprehensive telerehabilitation (HCTR) on the level of anxiety in comparison to usual care (UC). The TELEREH-HF study was a multicenter prospective RCT in 850 clinically stable HF participants. Patients underwent clinical examinations, including the assessment of anxiety, at entry and after the 9-week training program (HCTR) or observation (UC). The State-Trait Anxiety Inventory (STAI) was used. 20.3% HCTR and 20.1% UC patients reported high level of anxiety as a state at baseline, with higher STAI results in younger participants (< 63 y.o.) (p = .048 for HCTR; p = .026 for UC). At both stages of the study, patients with lower level of physical capacity (measured by a peak VO2) had shown significantly higher level of anxiety. There were no significant changes in anxiety levels during the 9-week observation for the entire study population, although there were different patterns of change in anxiety (both trait and state) in younger and older groups,with the decrease in younger patients, and the increase-in the older group.Trial registry number NCT02523560 (Clinical Trials.gov), date of registration: August 14, 2015.

Predictors of proarrhythmic effect in heart failure patients after 9-week hybrid comprehensive telerehabilitation and their influence on cardiovascular mortality in long-term follow-up: Subanalysis of the TELEREH-HF randomized clinical trial.

BACKGROUND: Regular exercise training is beneficial in heart failure (HF) patients. However, its potential proarrhythmic effect is possible but has not been sufficiently investigated. OBJECTIVE: To identify patients at risk for proarrhythmic effect after the 9-week of hybrid comprehensive telerehabilitation (HCTR) program vs the 9-week of usual care (UC) and to investigate its predictors and impact on cardiovascular mortality based on data from the TELEREH-HF RCT. METHODS: Proarrhythmic effect, strictly defined on the basis of available standards was evaluated by comparing 24-h Holter ECG before and after 9-week of HCTR or UC of 773 HF patients (The New York Heart Association class I-III, left ventricular ejection fraction ≤40%). RESULTS: The proarrhytmic effect was found in 78 (20.4%) and in 61 (15.6%) patients in the HCTR and UC group respectively, and the difference between groups was not statistically significant (p = 0.081). However, univariate analysis identified several statistically significant predictors of proarrhythmia in HCTR only vs the UC group. After a multivariate analysis ischaemic aetiology of HF (OR = 2.27, p = 0.008), peak oxygen consumption at baseline <14 ml/kg/min (OR = 2.03, p = 0.012) and level of N-terminal-pro B-type natriuretic peptide (NT-proBNP) in the first and the second tercile (OR = 1.85, p = 0.043) were identified to be independent predictors of proarrhytmic effect of exercise training among the HF patients in HCTR group only. CONSLUSIONS: Patients who underwent a 9-week HCTR were not at a higher risk of proarrhythmic effect after its completion compared to UC. However, predictors of proarrhythmia such as ischemic aetiology of HF, poor physical capacity, lower NT-proBNP level were discovered in the HCTR group only, yet it does not cause a significant risk of cardiovascular mortality including sudden cardiac death in long-term follow-up.

Effects of hybrid comprehensive telerehabilitation on cardiopulmonary capacity in heart failure patients depending on diabetes mellitus: subanalysis of the TELEREH-HF randomized clinical trial.

BACKGROUND: Type 2 diabetes mellitus (DM) is one of the most common comorbidities among patients with heart failure (HF) with reduced ejection fraction (HFrEF). There are limited data regarding efficacy of hybrid comprehensive telerehabilitation (HCTR) on cardiopulmonary exercise capacity in patients with HFrEF with versus those without diabetes. AIM: The aim of the present study was to analyze effects of 9-week HCTR in comparison to usual care on parameters of cardiopulmonary exercise capacity in HF patients according to history of DM. METHODS: Clinically stable HF patients with left ventricular ejection fraction [LVEF] < 40% after a hospitalization due to worsening HF within past 6 months were enrolled in the TELEREH-HF (The TELEREHabilitation in Heart Failure Patients) trial and randomized to the HCTR or usual care (UC). Cardiopulmonary exercise tests (CPET) were performed on treadmill with an incremental workload according to the ramp protocol. RESULTS: CPET was performed in 385 patients assigned to HCTR group: 129 (33.5%) had DM (HCTR-DM group) and 256 patients (66.5%) did not have DM (HCTR-nonDM group). Among 397 patients assigned to UC group who had CPET: 137 (34.5%) had DM (UC-DM group) and 260 patients (65.5%) did not have DM (UC-nonDM group). Among DM patients, differences in cardiopulmonary parameters from baseline to 9 weeks remained similar among HCTR and UC patients. In contrast, among patients without DM, HCTR was associated with greater 9-week changes than UC in exercise time, which resulted in a statistically significant interaction between patients with and without DM: difference in changes in exercise time between HCTR versus UC was 12.0 s [95% CI - 15.1, 39.1 s] in DM and 43.1 s [95% CI 24.0, 63.0 s] in non-DM, interaction p-value = 0.016. Furthermore, statistically significant differences in the effect of HCTR versus UC between DM and non-DM were observed in ventilation at rest: - 0.34 l/min [95% CI - 1.60, 0.91 l/min] in DM and 0.83 l/min [95% CI - 0.06, 1.73 l/min] in non-DM, interaction p value = 0.0496 and in VE/VCO2 slope: 1.52 [95% CI - 1.55, 4.59] for DM vs. - 1.44 [95% CI - 3.64, 0.77] for non-DM, interaction p value = 0.044. CONCLUSIONS: The benefits of hybrid comprehensive telerehabilitation versus usual care on the improvement of physical performance, ventilatory profile and gas exchange parameters were more pronounced in patients with HFrEF without DM as compared to patients with DM. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02523560. Registered 3rd August 2015. https://clinicaltrials.gov/ct2/show/NCT02523560?term=NCT02523560&draw=2&rank=1 . Other Study ID Numbers: STRATEGME1/233547/13/NCBR/2015.

Assessment of ECG during hybrid comprehensive telerehabilitation in heart failure patients-Subanalysis of the Telerehabilitation in Heart Failure Patients (TELEREH-HF) randomized clinical trial.

BACKGROUND: Exercise training in heart failure (HF) patients should be monitored to ensure patients' safety. Electrocardiographic (ECG) telemonitoring was used to assess the safety of hybrid comprehensive telerehabilitation (HCTR). OBJECTIVE: Analysis of ECG recorded during HCTR in HF patients. METHODS: The TELEREH-HF multicenter, randomized, controlled trial enrolled 850 HF patients with New York Heart Association class I-III and left ventricular ejection fraction of ≤40%. This subanalysis focuses on 386 patients (aged 62 ± 11 years, LVEF 31 ± 7%) randomized to HCTR. HCTR was telemonitored with a device allowing to record 16-s fragments of ECG and to transmit the data via mobile phone network to the monitoring center. ResultsIn 386 patients, 16,622 HCTR sessions were recorded and 66,488 ECGs fragments were evaluated. Sinus rhythm was present in 320 (83%) and permanent atrial fibrillation (AF) in 66 (17%) patients, respectively. The most common arrhythmias were ventricular and atrial premature beats, recorded in 76.4% and 27.7% of the patients, respectively. Non-sustained ventricular tachycardia (21 episodes in 8 patients) and paroxysmal AF episodes (6 in 4 patients) were rare. None of the analyzed demographic and clinical characteristics was predictive for onset of the new arrhythmias on exercise. CONCLUSION: Telerehabilitation in HF patients was safe without the evidence for symptomatic arrhythmias requiring discontinuation of telerehabilitation. Only one mildly symptomatic paroxysmal AF episode led to the short-term suspension of the training program. The most common arrhythmias were atrial and ventricular premature beats. These arrhythmias did not result in any changes in rehabilitation and therapy regimens.

[Effects of hybrid comprehensive cardiac telerehabilitation conducted under the pension prevention program of the Social Insurance Institution]. / Efekty hybrydowej kompleksowej telerehabilitacji kardiologicznej realizowanej w ramach prewencji rentowej Zakladu Ubezpieczen Spolecznych.

BACKGROUND: The Polish Social Insurance Institution (SII), under its pension prevention initiative, has taken measures to support the patients return to work and thus developed a new model of hybrid, comprehensive, cardiac telerehabilitation (HCCT). The aim of the study was to analyze the effects of HCCT in terms of its acceptance, adherence to and influence on patients' physical capacity and ability to return to work. MATERIAL AND METHODS: The study included 99 patients, aged 54.6±6.3 years, who suffered from cardiovascular diseases. They participated in a 24-day HCCT consisting of preliminary and final examinations, 10 days of out-patients rehabilitation based on cycloergometer training (5 sessions) and Nordic walking training (10 sessions), and 12 days of home telerehabilitation based on Nordic walking training. The effectiveness of HCCT was assessed by comparing changes in functional capacity expressed by metabolic equivalent of task (MET) and a 6-min walking test (6-MWT) distance from the beginning and the end of HCCT. Acceptance of HCCT was evaluated using a questionnaire. Adherence to HCCT was assessed by the patients' participation in the training sessions. Effectiveness of HCCT in terms of return to work was assessed according to SII definition. RESULTS: Hybrid, comprehensive, cardiac telerehabilitation resulted in significant improvement of functional capacity 7.6±2.0 vs. 8.1±2.4 MET (p < 0.0001) and distance in 6-MWT 448.5±79.2 m vs. 480.5±84.1 m (p < 0.0001). There were 82.8% of adherent, 16.2% of partially adherent and 1% of non-adherent patients. After HCCT 48 patients were able to return to work. CONCLUSIONS: Hybrid, comprehensive, cardiac telerehabilitation was well accepted and led to the improvement of the patients' physical capacity. Adherence to HCCT was high and allowed 48.48% of patients return to work. Med Pr 2017;68(1):61-74.

Implantable cardioverter-defibrillator therapy in a 34-year-old patient with eating disorders and after the third sudden cardiac arrest.

Eating disorders (ED) such as anorexia nervosa and bulimia are psychiatric diseases associated with the highest mortality rate of any other psychiatric disorders. More recently, long-term outcome studies with follow-up of over 20 years report a mortality of between 15% and 18% (Casiero and Frishman, Cardiol Rev 14(5), 227, 2006). The sudden death secondary to arrhythmias is often the cause of death in these patients (Casiero and Frishman, Cardiol Rev 14(5), 227, 2006). A case of life-threatening ventricular arrhythmia (VA) in a patient with ED is presented. Clinical records (cardiologic, psychiatric), electrocardiograms, echocardiogram, coronary angiogram, cardiac magnetic resonance, and endocrine diagnostics were performed. Finally a cardioverter-defibrillator (ICD) was implanted in the patient after her third cardiac arrest. An optimal approach to antiarrhythmic therapy in such patients is a real challenge for a cardiologist.

How should we advise heart failure patients on exercise and what should we tell them?

The article discusses the problem of motivating and encouraging patients with heart failure to perform regular exercise training. Firstly, the benefits of exercise training are presented, and rational and convincing arguments justifying its implementation in heart failure patients are provided. Secondly, the issue of overcoming barriers to exercise training implementation is considered. Finally, the role of the medical team and family members in supporting patients with heart failure in long-term adherence to recommendations is defined and analyzed. In addition, the article presents various ways of performing exercise training easily.

The potential of virtual triage AI to improve early detection, care acuity alignment, and emergent care referral of life-threatening conditions.

Objective: To evaluate the extent to which patient-users reporting symptoms of five severe/acute conditions requiring emergency care to an AI-based virtual triage (VT) engine had no intention to get such care, and whose acuity perception was misaligned or decoupled from actual risk of life-threatening symptoms. Methods: A dataset of 3,022,882 VT interviews conducted over 16 months was evaluated to quantify and describe patient-users reporting symptoms of five potentially life-threatening conditions whose pre-triage healthcare intention was other than seeking urgent care, including myocardial infarction, stroke, asthma exacerbation, pneumonia, and pulmonary embolism. Results: Healthcare intent data was obtained for 12,101 VT patient-user interviews. Across all five conditions a weighted mean of 38.5% of individuals whose VT indicated a condition requiring emergency care had no pre-triage intent to consult a physician. Furthermore, 61.5% intending to possibly consult a physician had no intent to seek emergency medical care. After adjustment for 13% VT safety over-triage/referral to ED, a weighted mean of 33.5% of patient-users had no intent to seek professional care, and 53.5% had no intent to seek emergency care. Conclusion: AI-based VT may offer a vehicle for early detection and care acuity alignment of severe evolving pathology by engaging patients who believe their symptoms are not serious, and for accelerating care referral and delivery for life-threatening conditions where patient misunderstanding of risk, or indecision, causes care delay. A next step will be clinical confirmation that when decoupling of patient care intent from emergent care need occurs, VT can influence patient behavior to accelerate care engagement and/or emergency care dispatch and treatment to improve clinical outcomes.

Feasibility of hybrid telerehabilitation as a component of the Managed Care after Acute Myocardial Infarction (MC-AMI) program in a 12-month follow-up: experience from a single center.

INTRODUCTION: Managed Care after Myocardial Infarction (MC­AMI [KOS-Zawal]), a comprehensive care program dedicated to patients after myocardial infarction, was implemented in Poland in 2017. Hybrid cardiac telerehabilitation (HTR) is a unique component of MC­AMI. OBJECTIVES: We evaluated the feasibility of HTR as a component of MC­AMI and assessed its safety and acceptance by patients. One­year all­cause mortality among the patients participating and not participating in MC­AMI was analyzed. PATIENTS AND METHODS: The MC­AMI group included 114 patients who underwent a 5­week HTR program comprising telemonitored Nordic walking training sessions, and who completed the entire 12­month MC­AMI program. The influence of HTR on the physical capacity was assessed by comparing the stress test results before and after HTR. After HTR, the patients completed a satisfaction survey to assess their acceptance of the program. The non-MC­AMI group was formed using propensity score matching to compare 1­year all­cause mortality between the patients participating and not participating in MC-AMI. RESULTS: HTR significantly improved the functional capacity assessed in the stress test and was well­received by the patients. In the study group, nonfatal non-ST­segment elevation myocardial infarction, elective coronary percutaneous intervention, and cardiovascular hospitalization occurred in 0.9%, 2.6% and 6.1% of the patients, respectively. There were no deaths among the MC­AMI participants, whereas in the non-MC­AMI group, 1­year all­cause mortality was 3.5%. The log­rank test comparing the survival probabilities of matched groups, estimated by the Kaplan-Meier method, showed heterogeneity of the curves (P = 0.04). CONCLUSIONS: HTR as a component of MC­AMI was a feasible, safe, and well­accepted form of cardiac rehabilitation. Participation in MC­AMI including HTR was associated with a significantly lower risk of 1­year all­cause mortality, as compared with not taking part in the rehabilitation program.

How Virtual Triage Can Improve Patient Experience and Satisfaction: A Narrative Review and Look Forward.

Objective: To complete a review of the literature on patient experience and satisfaction as relates to the potential for virtual triage (VT) or symptom checkers to enhance and enable improvements in these important health care delivery objectives. Methods: Review and synthesis of the literature on patient experience and satisfaction as informed by emerging evidence, indicating potential for VT to favorably impact these clinical care objectives and outcomes. Results/Conclusions: VT enhances potential clinical effectiveness through early detection and referral, can reduce avoidable care delivery due to late clinical presentation, and can divert primary care needs to more clinically appropriate outpatient settings rather than high-acuity emergency departments. Delivery of earlier and faster, more acuity level-appropriate care, as well as patient avoidance of excess care acuity (and associated cost), offer promise as contributors to improved patient experience and satisfaction. The application of digital triage as a front door to health care delivery organizations offers care engagement that can help reduce patient need to visit a medical facility for low-acuity conditions more suitable for self-care, thus avoiding unpleasant queues and reducing microbiological and other patient risks associated with visits to medical facilities. VT also offers an opportunity for providers to make patient health care experiences more personalized.

The Role of Virtual Triage in Improving Clinician Experience and Satisfaction: A Narrative Review.

Objective: This review examines the literature on improving clinician satisfaction with a focus on what has been most effective in improving experience from the perspective of clinicians, and the potential role that virtual triage (VT) technology can play in delivering positive clinician experiences that improve clinical care, and bring value to health care delivery organizations (HDOs). Methods: Review and synthesis of evidence on clinician satisfaction indicating a potential for VT to favorably impact clinician experience, sense of effectiveness, efficiency, and reduction of administrative task burden. Analysis considers how to conceptualize and the value of improving clinician experience, leading clinician dissatisfiers, and the potential role of VT in improving clinician experience/satisfaction. Results: Contributors to poor clinician experience/satisfaction where VT could have a beneficial impact include better managing resource limitations, administrative workload, lack of care coordination, information overload, and payer interactions. VT can improve clinician experience through the technology's ability to leverage real-time actionable data clinicians can use, streamlining patient-clinician communications, personalizing care delivery, optimizing care coordination, and better aligning digital/virtual services with clinical practice. From an organizational perspective, improvements in clinician experience and satisfaction derive from establishing an effective digital back door, increasing the clinical impact of and satisfaction derived from telemedicine and virtual care, and enhancing clinician centricity. Conclusions: By embracing digital transformation and implementing solutions such as VT that focus on improving patient and clinician experience, HDOs can address barriers to delivery of high-quality, efficient, and cost-effective care. VT is a digital health tool that can create a more streamlined and satisfying experience for clinicians and the patients they care for. VT is a technology solution that can help clinicians make faster more informed decisions, reduces avoidable care, improves communication with patients and within care teams, and lowers their administrative burden so they have more quality time to care for patients.

Predictors of long-term prognosis based on clinical status and measurements obtained in heart failure patients after 9-week hybrid comprehensive telerehabilitation: A subanalysis of the TELEREH-HF randomized clinical trial.

BACKGROUND: Assessing prognosis in heart failure (HF) is of major importance. AIMS: The study aimed to define predictors influencing long-term cardiovascular mortality or HF hospitalization ("composite outcome") based on clinical status and measurements obtained after a 9-week hybrid comprehensive telerehabilitation (HCTR) program. METHODS: This analysis is based on the TELEREH-HF (TELEREHabilitation in Heart Failure) multicenter randomized trial that enrolled 850 HF patients (left ventricular ejection fraction [LVEF] ≤40%). Patients were randomized 1:1 to 9-week HCTR plus usual care (experimental arm) or usual care only (control arm) and followed for median (interquartile range [IQR]) 24 (20-24) months for development of the composite outcome. RESULTS: Over 12-24 months of follow-up, 108 (28.1%) patients experienced the composite outcome. The predictors of our composite outcome were: nonischemic etiology of HF, diabetes, higher serum level of N-terminal prohormone of brain natriuretic peptide, creatinine, and high-sensitivity C-reactive protein; low carbon dioxide output at peak exercise; high minute ventilation and breathing frequency at maximum effort in cardiopulmonary exercise tests; increase in delta of average heart rate in 24-hour Holter ECG monitoring, lower LVEF, and patients' non-adherence to HCTR. The model discrimination C-index was 0.795 and decreased to 0.755 on validation conducted in the control sample which was not used in derivation. The 2-year risk of the composite outcome was 48% in the top tertile versus 5% in the bottom tertile of the developed risk score. CONCLUSION: Risk factors collected at the end of the 9-week telerehabilitation period performed well in stratifying patients based on their 2-year risk of the composite outcome. Patients in the top tertile had an almost ten-fold higher risk compared to patients in the bottom tertile. Treatment adherence, but not peak VO2 or quality of life, was significantly associated with the outcome.

A multinational survey of patient utilization of and value conveyed through virtual symptom triage and healthcare referral.

Objective: To describe the use patterns, impact and derived patient-user value of a mobile web-based virtual triage/symptom checker. Methods: Online survey of 2,113 web-based patient-users of a virtual triage/symptom checker was completed over an 8-week period. Questions focused on triage and care objectives, pre- and post-triage care intent, frequency of use, value derived and satisfaction with virtual triage. Responses were analyzed and stratified to characterize patient-user pre-triage and post-triage intent relative to triage engine output. Results: Seventy-eight percent of virtual triage users were female, and 37% were 18-24 years old or younger, 28% were 25-44, 16% were 45-54, and 19% were 55 years or older; 41.2% completed the survey from the U.S., 12.5% from the U.K., 9.1% from Canada, 5.6% from India, 3.8% from South Africa. Motivations were to determine need to consult a physician (44.2%), to secure medical advice without visiting a physician (21.0%), and to confirm a diagnosis received (14.2%). Forty-three percent were first time users of virtual triage, 36.6% utilized a triage engine at least once every few months or more often. Pre-triage, 40.5% did not know what level of healthcare they were planning to utilize, 33.9% stated they intended to seek a physician consultation, 23.7% engage self-care and 1.8% seek emergency care. Virtual triage recommended 56.8% of patient-users consult a physician, 33.8% seek emergency care and 9.4% engage self-care. In three-fourths, virtual triage helped users decide level of care to pursue. Among 74.1%, triage recommended care different than pre-triage intentions. Post-triage, those who remained uncertain of their care path decreased by 25.4%. Patient-user experience and satisfaction with virtual triage was high, with 80.1% stating that they were highly likely or likely to use it again, and interest in and willingness to use telemedicine doubled. Conclusion: Virtual triage successfully redirected patient-users who initially planned to seek an inappropriate level of care acuity, reduced patient uncertainty of care path, and doubled the percentage of patients amenable to telemedicine and virtual health engagement. Patient-users were highly satisfied with virtual triage and the virtual triage patient experience, and a large majority will use virtual triage recurrently in the future.

Relationship between physical capacity and depression in heart failure patients undergoing hybrid comprehensive telerehabilitation vs. usual care: subanalysis from the TELEREH-HF Randomized Clinical Trial.

AIMS: The hybrid comprehensive telerehabilitation (HCTR) consisting of telecare (with psychological telesupport), telerehabilitation, and remote monitoring of cardiovascular implantable electronic devices might be an option to improve both physical capacity and depressive symptoms. The aim of the study was to investigate the influence of HCTR on depressive symptoms and physical capacity in heart failure (HF) patients in comparison with usual care (UC). METHODS AND RESULTS: The present analysis formed part of a multicentre, randomized trial that enrolled 850 HF patients (New York Heart Association I-III, left ventricular ejection fraction ≤ 40%). Patients were randomized 1:1 to HCTR or UC. Patients underwent an HCTR programme (1 week in hospital and 8 weeks at home; exercise training 5 times weekly) or UC with observation. The Beck Depression Inventory II (BDI-II) score (cut point for depression ≥ 14) was used to assess depression and the physical capacity was measured by peak oxygen consumption (peak VO2; mL/kg/min). Measurements were made before and after 9-week intervention/observation (HCTR/UC group). Both groups were comparable in terms of demographic and clinical characteristics. In HCTR group, at entry, 23% of the sample obtained BDI-II scores ≥14 vs. 27.5% in UC group. There were no significant differences between groups regarding ΔBDI-II score (P = 0.992) after 9-week HCTR/UC. There was a significant improvement in physical capacity only in the HCTR group in both patients with (P = 0.033) and without (P < 0.001) depression. CONCLUSIONS: In HF patients, HCTR provided similar reduction of depressive symptoms as UC. HCTR resulted in a significant improvement in physical capacity in patients with and without depression.

Prognostic Impact of Hybrid Comprehensive Telerehabilitation Regarding Diastolic Dysfunction in Patients with Heart Failure with Reduced Ejection Fraction-Subanalysis of the TELEREH-HF Randomized Clinical Trial.

AIMS: The objective of the study was to evaluate the effects of individually prescribed hybrid comprehensive telerehabilitation (HCTR) implemented at patients' homes on left ventricular (LV) diastolic function in heart failure (HF) patients. METHODS AND RESULTS: The Telerehabilitation in Heart Failure Patients trial (TELEREH-HF) is a multicenter, prospective, randomized (1:1), open-label, parallel-group, controlled trial involving HF patients assigned either to HCTR involving a remotely monitored home training program in conjunction with usual care (HCTR group) or usual care only (UC group). The patient in the HCTR group underwent a 9-week HCTR program consisting of two stages: an initial stage (1 week) conducted in hospital and the subsequent stage (eight weeks) of home-based HCTR five times weekly. Due to difficulties of proper assessment and differences in the evaluation of diastolic function in patients with atrial fibrillation, we included in our subanalysis only patients with sinus rhythm. Depending on the grade of diastolic dysfunction, patients were assigned to subgroups with mild diastolic (MDD) or severe diastolic dysfunction (SDD), both in HCTR (HCTR-MDD and HCTR-SDD) and UC groups (UC-MDD and UC-SDD). Changes from baseline to 9 weeks in echocardiographic parameters were seen only in A velocities in HCTR-MDD vs. UC-MDD; no significant shifts between groups of different diastolic dysfunction grades were observed after HCTR. All-cause mortality was higher in UC-SDD vs. UC-MDD with no difference between HCTR-SDD and HCTR-MDD. Higher probability of HF hospitalization was observed in HCTR-SDD than HCTR-MDD and in UC-SDD than UC-MDD. No differences in the probability of cardiovascular mortality and hospitalization were found. CONCLUSIONS: HCTR did not influence diastolic function in HF patients in a significant manner. The grade of diastolic dysfunction had an impact on mortality only in the UC group and HF hospitalization over a 12-24-month follow-up in HCTR and UC groups.

Antiarrhythmic effect of 9-week hybrid comprehensive telerehabilitation and its influence on cardiovascular mortality in long-term follow-up - subanalysis of the TELEREHabilitation in Heart Failure Patients randomized clinical trial.

Introduction: Cardiac rehabilitation is a component of heart failure (HF) management, but its effect on ventricular arrhythmias is not well understood. We analyzed the antiarrhythmic effect of a 9-week hybrid comprehensive telerehabilitation (HCTR) program and its influence on long-term cardiovascular mortality in HF patients taken from the TELEREHabilitation in Heart Failure Patients (TELEREH-HF) trial. Material and methods: We evaluated the presence of non-sustained ventricular tachycardia (nsVT) and frequent premature ventricular complexes ≥ 10 beats/hour (PVCs ≥ 10) in 24-hour ECG monitoring at baseline and after 9-week HCTR or usual care (UC) of 773 HF patients (NYHA I-III, LVEF ≤ 40%). Functional response for HCTR was assessed by changes - delta (Δ) - in peak oxygen consumption (pVO2) as a result of comparing pVO2 from the beginning and the end of the program. Results: Among 143 patients with nsVT, arrhythmia subsided in 30.8% after HCTR. Similarly, among 165 patients randomized to UC who had nsVT 34.5% did not show it after 9 weeks (p = 0.481). There was no significant difference in the decrease in PVC ≥ 10 over 9 weeks between randomization arms (14.9% vs. 17.8%, respectively p = 0.410). Functional response for HCTR in ΔpVO2 > 2.0 ml/kg/min did not affect occurrence of arrhythmias. Multivariable analysis did not identify HCTR as an independent factor determining improvement of nsVT or PVCs ≥ 10. However, only in the HCTR group, the achievement of the antiarrhythmic effect significantly reduced the cardiovascular mortality in 2-year follow-up (p < 0.001). Conclusions: Significant improvement in physical capacity after 9 weeks of HCTR did not correlate with the antiarrhythmic effect in terms of incidence of nsVT or PVCs ≥ 10. An antiarrhythmic effect after the 9-week HCTR affected long-term cardiovascular mortality in HF patients.

Quality of life in heart failure patients undergoing hybrid comprehensive telerehabilitation versus usual care - results of the Telerehabilitation in Heart Failure Patients (TELEREH-HF) Randomized Clinical Trial.

INTRODUCTION: Hybrid comprehensive telerehabilitation (HCTR) consisting of telecare (with psychological telesupport), telerehabilitation and remote monitoring of implantable devices might be an innovative option improving heart failure (HF) patients' quality of life (QoL) and emotional health. The aim of the study was to investigate the influence of HCTR on various facets of QoL in HF patients in comparison with usual care (UC) alone. MATERIAL AND METHODS: The present analysis formed part of a multicenter, randomized trial that enrolled 850 HF patients (NYHA I-III, LVEF ≤ 40%). Patients were randomized 1 : 1 to HCTR plus UC or UC only. Patients underwent either an HCTR program or UC with observation. The psychological intervention in the HCTR group included supportive psychological counseling via mobile phone. The Medical Outcome Survey Short Form 36 Questionnaire was used to assess QoL. Measurements were made before and after a 9-week intervention (HCTR group)/observation (UC group). RESULTS: After the intervention, the HCTR group showed significant improvement in overall QoL, physical domain (PD) of QoL, and 4 areas of QoL (physical functioning (PhF), role functioning related to physical state (RF), general health (GH), vitality (VI)). A significant positive change in QoL in the UC group was observed only in VI and social functioning. There were also significant differences in QoL after 9-week intervention/observation between the two groups. The results showed greater improvement in HCTR for overall QoL (p = 0.009), PD of QoL (p = 0.0003) and three specific areas of QoL: PhF (p = 0.001), RF (p = 0.003), bodily pain (BP) (p = 0.015). CONCLUSIONS: In comparison to UC, HCTR resulted in improvement in overall QoL, PD of QoL and 3 specific areas of QoL: PhF, RF and BP.

An aetiology-based subanalysis of the Telerehabilitation in Heart Failure Patients (TELEREH-HF) trial.

AIMS: The aim of our study was to analyse the benefits of a 9 week hybrid comprehensive telerehabilitation (HCTR) programme in heart failure (HF) patients according to aetiology, as a subanalysis of the Telerehabilitation in Heart Failure Patients (TELEREH-HF) trial. METHODS AND RESULTS: Overall, 555 (65.3%) patients with ischaemic (IS) and 295 (34.7%) patients with non-ischaemic (NIS) HF aetiology were randomized. There were no differences between the effect of HCTR and usual care (UC) on the primary outcome of number of days alive and out of the hospital in 26 months from the time of randomization in either aetiology (Wilcoxon-Mann-Whitney test), and no heterogeneity of effect between the aetiologies was noted (van Elteren test, P = 0.746). In Cox proportional hazards regression analysis, treatment was not independently associated with the secondary outcomes. For all-cause mortality, the adjusted hazard ratio for HCTR vs. UC was 0.90 (95% confidence interval, 0.54-1.51) in IS and 1.42 (95% confidence interval, 0.69-2.94) in NIS (P interaction = 0.316). Differences between HCTR and UC in terms of change in the 6 min walk test distance and cardiopulmonary exercise test time after 9 weeks reached statistical significance in the IS arm (P = 0.015 and P < 0.001, respectively), but not in the NIS arm; however, tests of heterogeneity indicated no statistically significant differences. CONCLUSIONS: The trial showed no difference between HCTR and UC in the primary outcome of percentage of days alive and out of the hospital for either IS or NIS aetiology. Moreover, the magnitude of changes in the clinical and functional statuses of the HF patients did not differ by aetiology. HCTR might have had beneficial effects on the 6 min walk test distance and cardiopulmonary exercise test time after 9 weeks in the IS patients; however, the effect was not statistically significantly different from that observed in the NIS patients.

Remote Monitoring of Cardiac Implantable Electronic Devices in Patients Undergoing Hybrid Comprehensive Telerehabilitation in Comparison to the Usual Care. Subanalysis from Telerehabilitation in Heart Failure Patients (TELEREH-HF) Randomised Clinical Trial.

BACKGROUND: The impact of cardiac rehabilitation on the number of alerts in patients with remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) is unknown. We compared alerts in RM and outcomes in patients with CIEDs undergoing hybrid comprehensive telerehabilitation (HCTR) versus usual care (UC). METHODS: Patients with heart failure (HF) after a hospitalization due to worsening HF within the last 6 months (New York Heart Association (NYHA) class I-III and left ventricular ejection fraction (LVEF) ≤40%) were enrolled in the TELEREH-HF study and randomised 1:1 to HCTR or UC. Patients with HCTR and CIEDs received RM (HCTR-RM). Patients with UC and CIEDs were offered RM optionally (UC-RM). Data from the initial 9 weeks of the study were analysed. RESULTS: Of 850 enrolled patients, 208 were in the HCTR-RM group and 62 in the UC-RM group. The HCTR-RM group was less likely to have alerts of intrathoracic impedance (TI) decrease (p < 0.001), atrial fibrillation (AF) occurrence (p = 0.031) and lower mean number of alerts per patient associated with TI decrease (p < 0.0001) and AF (p = 0.019) than the UC-RM group. HCTR significantly decreased the occurrence of alerts in RM of CIEDs, 0.360 (95%CI, 0.189-0.686; p = 0.002), in multivariable regression analysis. There were two deaths in the HCTR-RM group (0.96%) and no deaths in the UC-RM group (p = 1.0). There were no differences in the number of hospitalised patients between the HCTR-RM and UC-RM group (p = 1.0). CONCLUSIONS: HCTR significantly reduced the number of patients with RM alerts of CIEDs related to TI decrease and AF occurrence. There were no differences in mortality or hospitalisation rates between HCTR-RM and UC-RM groups.

Effects of a 9-Week Hybrid Comprehensive Telerehabilitation Program on Long-term Outcomes in Patients With Heart Failure: The Telerehabilitation in Heart Failure Patients (TELEREH-HF) Randomized Clinical Trial.

Importance: Guidelines recommend exercise training as a component of heart failure management. There are large disparities in access to rehabilitation, and introducing hybrid comprehensive telerehabilitation (HCTR) consisting of remote monitoring of training at patients' homes might be an appealing alternative. Objective: To assess whether potential improvements in quality-of-life outcomes after a 9-week HCTR intervention in patients with heart failure translate into improvement in clinical outcomes during extended 12 to 24 months of follow-up, compared with usual care. Design, Setting, and Participants: The Telerehabilitation in Heart Failure Patients (TELEREH-HF) trial is a multicenter, prospective, open-label, parallel-group randomized clinical trial that enrolled 850 patients with heart failure up to 6 months after a cardiovascular hospitalization with New York Heart Association levels I, II, or III and left ventricular ejection fraction of 40% or less. Patients from 5 centers in Poland were randomized 1:1 to HCTR plus usual care or usual care only and followed up for 14 to 26 months after randomization. Interventions: During the first 9 weeks, patients underwent either an HCTR program (1 week in hospital and 8 weeks at home) or usual care with observation. The HCTR intervention encompassed telecare, telerehabilitation, and remote monitoring of implantable devices. No intervention occurred in the remaining study period. Main Outcomes and Measures: The percentage of days alive and out of the hospital from randomization through the end of follow-up at 14 to 26 months. Results: A total of 850 patients were enrolled, with 425 randomized to the HCTR group (377 male patients [88.7%]; mean [SD] age, 62.6 [10.8] years) and 425 randomized to usual care (376 male patients [88.5%]; mean [SD] age, 62.2 [10.2] years). The HCTR intervention did not extend the percentage of days alive and out of the hospital. The mean (SD) days were 91.9 (19.3) days in the HCTR group vs 92.8 (18.3) days in the usual-care group, with the probability that HCTR extends days alive and out of the hospital equal to 0.49 (95% CI, 0.46-0.53; P = .74) vs usual care. During follow-up, 54 patients died in the HCTR arm and 52 in the usual-care arm, with mortality rates at 26 months of 12.5% vs 12.4%, respectively (hazard ratio, 1.03 [95% CI, 0.70-1.51]). There were also no differences in hospitalization rates (hazard ratio, 0.94 [95% CI, 0.79-1.13]). The HCTR intervention was effective at 9 weeks, significantly improving peak oxygen consumption (0.95 [95% CI, 0.65-1.26] mL/kg/min vs 0.00 [95% CI, -0.31 to 0.30] mL/kg/min; P < .001) and quality of life (Medical Outcome Survey Short Form-36 questionnaire score, 1.58 [95% CI, 0.74-2.42] vs 0.00 [95% CI, -0.84 to 0.84]; P = .008), and it was well tolerated, with no serious adverse events during exercise. Conclusions and Relevance: In this trial, the positive effects of a 9-week program of HCTR in patients with heart failure did not lead to the increase in percentage of days alive and out of the hospital and did not reduce mortality and hospitalization over a follow-up period of 14 to 26 months. Trial Registration: ClinicalTrials.gov identifier: NCT02523560.