Telemedicine home-based management in patients with chronic heart failure and diabetes type II: study protocol for a randomized controlled trial.

BACKGROUND: Heart failure and type 2 diabetes are prevalent public health issues in Europe. These complex chronic conditions require extensive pharmacological management, ongoing self-care, and behavioral changes. Despite the known benefits of lifestyle changes, such as regular exercise and better control of blood sugar levels, patients may need help implementing the recommended changes. This study aims to assess the effectiveness of a telemedicine program for managing heart failure and type 2 diabetes at home. The program focuses on promoting lifestyle changes. METHODS AND ANALYSIS: During scheduled outpatient cardiology evaluations, eligible patients are recruited and randomly assigned to either an intervention or control group in a 1:1 ratio. The intervention group receives support from a nursing case manager through a structured home-based teleassistance program and a trainer for daily physical activity stimulation. They also have access to teleconsultations with cardiologists and diabetes specialists as needed, telemonitoring of vital signs, and daily step tracking. An app records and monitors daily drug treatment, glycemia, blood pressure, heart rate, and other clinical parameters. Patients can also self-report symptoms and communicate via a chat and videoconference system with a Nurse Case Manager. The control group receives routine care. Data collection occurs before intervention and 6 months after baseline during a new outpatient cardiology evaluation. The primary outcome is to measure the difference in the distance walked during a 6-min walk test between baseline and after 6 months. The key secondary outcomes include improving the disease status and physical activity profile. Data will be analyzed according to the intention-to-treat principles. DISCUSSION: This study will provide evidence on the efficacy of a telemedicine home-based management model to maintain correct lifestyles in patients with both heart failure and type 2 diabetes, improving self-management, their empowerment on the diseases, and increasing their knowledge and ability to recognize symptoms early. TRIAL REGISTRATION: ClinicalTrials.gov NCT05633784. Registered on November 30, 2022.

Estimating maximum work rate during cardiopulmonary exercise testing from the six-minute walk distance in patients with heart failure.

Background: Exercise is recommended for patients with chronic heart failure (CHF) and its intensity is usually set as a percentage of the maximal work rate (MWR) during cardiopulmonary exercise testing (CPX) or a symptom-limited incremental test (SLIT). As these tests are not always available in cardiac rehabilitation due to logistic/cost constraints, we aimed to develop a predictive model to estimate MWR at CPX (estMWR@CPX) in CHF patients using anthropometric and clinical measures and the 6-min walk test (6 MWT), the most widely used exercise field test. Methods: This is a multicentre cross-sectional retrospective study in a cardiac rehabilitation setting. Six hundred patients with HF in New York Heart Association (NYHA) functional class I-III underwent both CPX and 6 MWT and, through multivariable linear regression analysis, we defined several predictive models to define estMWR@CPX. Results: The best model included 6 MWT, sex, age, weight, NYHA class, left ventricular ejection fraction (LVEF), smoking status and chronic obstructive pulmonary disease COPD (adjusted R2 = 0.55; 95% LoA -39 to 33 W). When LVEF was excluded as a predictor, the resulting model performed only slightly worse (adjusted R2 = 0.54; 95% LoA -42 to 34 W). Only in 34% of cases was the percentage difference between estMWR@CPX and real MWR@CPX <10% in absolute value. EstMWR@CPX tended to overestimate low values and underestimate high values of true MWR@CPX. Conclusions: Our results showed a lack of accuracy in the predictive model evaluated; therefore, for an accurate prescription of cycle-ergometer exercise training, it is necessary to assess MWR by CPX or SLIT.

Home-based exercise program for people with residual disability following hospitalization for COVID-19: Randomized control trial.

BACKGROUND: The best exercise program for individuals with effort intolerance or hypoxia at rest and/or during exercise post-COVID-19 treatment who have already had in-hospital rehabilitation remains unknown. OBJECTIVE: We evaluated the efficacy of a home-based rehabilitation exercise program intervention that included teleconsultations with a specialist nurse. METHODS: This was a multicenter randomized controlled trial for individuals who had been diagnosed with, and treated for, COVID-19. Despite inpatient rehabilitation they still had effort intolerance; this was defined as being a) only able to walk <70 % of the predicted distance during the six-minute walking test (6MWT) and/or b) oxygen desaturation all day long/during effort. The primary outcome was effort tolerance, as evaluated by the 6MWT. Secondary outcomes were dyspnea, fatigue, spirometry, respiratory muscle evaluations, and oxygenation. The Intervention group performed 4 weeks of a self-directed exercise program with bi-weekly physiotherapist video calls; the Control group participated in physical activity howsoever they wished. Exercises were divided into 4 intensity levels according to disability and oxygen desaturation. The program progressively increased from low (walking, free-body exercise, sit-to-stand, and balance exercises) to high (speed walking with a pedometer, cycle ergometer, and strengthening exercises). RESULTS: We included 79 participants: 40 in the Intervention and 39 in the Control group. Mean (SD) age was 67.1 (10.3) years; 72 % (n = 57) were male. No intergroup differences in effort tolerance were found [Intervention 77.6 (75.4)m vs Control 49.5 (73.3)m (p = 0.109)]. Participants with 6MWT distance results < lower limit of normality values showed best improvements in mean (SD) effort tolerance: Intervention, 120.1 (75.8)m vs Control, 59.1 (75.6)m (p = 0.035). After 2 months, mean (SD) 6MWT distances in the 2 groups were similar: Intervention, 475.9 (82.4)m vs Control, 469.2 (118.9)m (p = 0.807). CONCLUSIONS: In individuals with residual disability post-COVID-19 and after inpatient rehabilitation, a home-based exercise program with teleconsultation significantly improves effort tolerance but only for people who had severe effort intolerance at baseline. DATABASE REGISTRATION: ClinicalTrials.gov number, NCT04821934.

Incremental prognostic value of functional impairment assessed by 6-min walking test for the prediction of mortality in heart failure.

Natriuretic peptides (NP) are recognized as the most powerful predictors of adverse outcomes in heart failure (HF). We hypothesized that a measure of functional limitation, as assessed by 6-min walking test (6MWT), would improve the accuracy of a prognostic model incorporating a NP. This was a multicenter observational retrospective study. We studied the prognostic value of severe functional impairment (SFI), defined as the inability to perform a 6MWT or a distance walked during a 6MWT < 300 m, in 1696 patients with HF admitted to cardiac rehabilitation. The primary outcome was 1-year all-cause mortality. After adjusting for the baseline multivariable risk model-including age, sex, systolic blood pressure, anemia, renal dysfunction, sodium level, and NT-proBNP-or for the MAGGIC score, SFI had an odds ratio of 2.58 (95% CI 1.72-3.88; p < 0.001) and 3.12 (95% CI 2.16-4.52; p < 0.001), respectively. Adding SFI to the baseline risk model or the MAGGIC score yielded a significant improvement in discrimination and risk classification. Our data suggest that a simple, 6MWT-derived measure of SFI is a strong predictor of death and provide incremental prognostic information over well-established risk markers in HF, including NP, and the MAGGIC score.

Usability of a continuous oxygen saturation device for home telemonitoring.

Background: The emergency for the COVID-19 pandemic has led to greater use of home telemonitoring devices. The aim of this study was to assess the usability of continuous home-monitoring care with an oxygen saturation device on post-COVID-19 patients. Method: The system consists of a digital continuous pulse oximeter and a smartphone with an App, which were provided to patients. A survey composed of a standard Post-Study System Usability Questionnaire, and a satisfaction questionnaire was exploited to conduct a usability and feasibility analysis of the service. Results: A total of 29 patients (17.2% female) with a mean age of 65 ± 11.5 years were enrolled: 20 patients were smartphone users (69%) with a mean age of 60.2 ± 9.5 years, and 9 patients (31%) did not own a smartphone (mean age 76.8 ± 5.9). The monitoring period was 1 month: a total of 444 recordings were conducted, 15 recordings per patient averagely. In total, 82% of the recordings performed did not require any intervention, while 18% led to the production of a report and subsequent intervention by a nurse who verified, together with the specialist, the need to intervene (i.e. the patient accessed the clinic for medical control and/or modification of oxygen therapy). A total of 17 patients compiled a usability questionnaire. The service was perceived as useful and well-structured, although it often required caregiver support. Conclusions: Using continuous home-monitoring care with an oxygen saturation device seems feasible and useful for patients who could be followed at home avoiding going back to the hospital every time a trend oximetry is needed. Further improvements in connections, data flow processes, and simplifications, based on patients' feedback, are needed to scale up the service.

COVID-19 teleassistance and teleconsultation: a matched case-control study (MIRATO project, Lombardy, Italy).

Background: During the COVID-19 pandemic, telemedicine has been recognised as a powerful modality to shorten the length of hospital stay and to free up beds for the sicker patients. Lombardy, and in particular the areas of Bergamo, Brescia, and Milan, was one of the regions in Europe most hit by the COVID-19 pandemic. The primary aim of the MIRATO project was to compare the incidence of severe events (hospital readmissions and mortality) in the first three months after discharge between COVID-19 patients followed by a Home-Based Teleassistance and Teleconsultation (HBTT group) program and those discharged home without Telemedicine support (non-HBTT group). Methods: The study was designed as a matched case-control study. The non-HBTT patients were matched with the HBTT patients for sex, age, presence of COVID-19 pneumonia and number of comorbidities. After discharge, the HBTT group underwent a telecare nursing and specialist teleconsultation program at home for three months, including monitoring of vital signs and symptoms. Further, in this group we analysed clinical data, patients' satisfaction with the program, and quality of life. Results: Four hundred twenty-two patients per group were identified for comparison. The median age in both groups was 70 ± 11 years (62% males). One or more comorbidities were present in 86% of the HBTT patients and 89% in the non-HBTT group (p = ns). The total number of severe events was 17 (14 hospitalizations and 3 deaths) in the HBTT group and 40 (26 hospitalizations and 16 deaths) in the non-HBTT group (p = 0.0007). The risk of hospital readmission or death after hospital discharge was significantly lower in HBTT patients (Log-rank Test p = 0.0002). In the HBTT group, during the 3-month follow-up, 5,355 teleassistance contacts (13 ± 4 per patient) were performed. The number of patients with one or more symptoms declined significantly: from 338 (78%) to 183 (45%) (p < 0.00001). Both the physical (ΔPCS12: 5.9 ± 11.4) component and the mental (ΔMCS12: 4.4 ± 12.7) component of SF-12 improved significantly (p < 0.0001). Patient satisfaction with the program was very high in all participants. Conclusions: Compared to usual care, an HBTT program can reduce severe events (hospital admissions/mortality) at 3-months from discharge and improve symptoms and quality of life. Clinical trial registration: www.ClinicalTrials.gov, NCT04898179.

ICF framework in cardiac rehabilitation: a real-life implementation in post-cardiac surgery and chronic heart failure patients.

BACKGROUND: The International Classification of Functioning, Disability, and Health (ICF) is growing in importance in cardiac rehabilitation (CR) as the number of elderly comorbid patients increases. AIM: To classify through the ICF framework a group of post-cardiac surgery (CS) and chronic heart failure (CHF) patients undergoing rehabilitation. Then, to compare the two groups and identify possible factors at admission that could affect ICF evaluations at discharge. DESIGN: Observational retrospective real-life study. SETTING: Two inpatient CR units. POPULATION: Consecutive CS and CHF patients admitted for CR (January-December 2019). METHODS: Clinical, anthropometric data and functional status at admission and discharge were extracted from patient health records. A set of 26 ICF codes regarding body functions (b) and activities (d) was analyzed to identify: 1) the qualifiers attributed (from 0=no impairment to 4=severe impairment) for each code, 2) the percent distribution of qualifiers (0/1/2/3/4) attributed per patient. We then evaluated changes in both (1) and (2 - defined as ICF Delta%) from admission to discharge. RESULTS: All patients (55% males; mean age 73±12 years) showed an improvement post-rehabilitation in the ICF qualifiers attributed (P<0.0001 for all codes). CS patients (N.=150) were less functionally impaired at admission than CHF (N.=194) (P<0.05 for all codes), and at discharge showed greater Delta% in the qualifiers 0/1/2 attributed than CHF (P<0.0001 for b codes; P<0.05 for d codes). Delta% for qualifiers 3 and 4 was similar in the two groups. No impairment at admission (qualifier 0), CS group, and presence/complexity of comorbidities were identified as possible covariates influencing ICF qualifiers at discharge, impacting the rate of both no/mild impairment (ICF% aggregate 0+1 - adjusted R2=0.627; P<0.0001) and moderate impairment (ICF% qualifier 2 - adjusted R2=0.507; P<0.0001). CONCLUSIONS: CHF patients showed a worse ICF picture at admission and less improvement at discharge than CS. The presence and complexity of comorbidities negatively influenced the ICF classification at discharge, especially in CHF patients. CLINICAL REHABILITATION IMPACT: This study shows the utility of ICF classification in CR as a means for describing, measuring, and comparing patient functioning across the care continuum.

Functional outcome after cardiac rehabilitation and its association with survival in heart failure across the spectrum of ejection fraction.

BACKGROUND: There is limited evidence regarding the effects of cardiac rehabilitation (CR) in patients with heart failure and preserved ejection fraction (HFpEF). METHODS: We studied 1784 patients admitted to inpatient CR. The patients were grouped into HFpEF (EF≥0.50), HF with mildly reduced EF (HFmrEF; EF 41-49), and HF with reduced EF (HFrEF; EF≤0.40). A standardized 6-min walking test was performed at admission and discharge. Measures of functional outcome were: (1) absolute increase in 6-min walking distance (6MWD) from admission to discharge >50 m and (2) increase in 6MWD to ≥300 among the patients who walked <300 m at admission. RESULTS: After adjustment, the patients with HFpEF or HFmrEF were as likely as those with HFrEF to achieve an increase in 6MWD >50 m (odds ratio 0.95 [95%CI 0.71-1.24; p=0.648] and 1.04 [95%CI 0.77-1.41; p=0.769], respectively) or an increase in 6MWD to ≥300 m (odds ratio 0.79 [95%CI 0.51-1.23; p=0.299] and 0.65 [95%CI 0.38-1.12; p=0.118], respectively). The adjusted hazard ratio of 5-year mortality for patients who achieved an increase in 6MWD >50 m was 0.60 (95%CI 0.51-0.71; p<0.001) and that for patients who achieved an increase in 6MWD at discharge to ≥300 m 0.61 (95%CI 0.48-0.79; p<0.001). In each EF group, both outcomes remained independently associated with improved survival. CONCLUSIONS: Our data suggest that patients with HFpEF or HFmrEF are as likely as those with HFrEF to benefit from CR in terms of functional improvement. Functional improvement was independently associated with improved long-term survival, regardless of EF.

Dysbiosis and leaky gut in hyper-inflated COPD patients: Have smoking and exercise training any role?

BACKGROUND: To characterize the leaky gut syndrome in a cohort of COPD patients with lung hyperinflation according to their clinical history (i.e. hyperinflation severity, chronic respiratory failure [CRF] presence, GOLD stage, prescribed therapy, smoking history) and with or without recent exercise training activity. METHODS: At the ambulatory visit, we evaluated selected COPD patients with lung hyperinflation [residual volume (RV)≥110% pred, TLC≤120% pred)] in clinical stability, identifying them as those who have attended a recent program of exercise training and those who were waiting for it. Clinical and respiratory characteristics (forced expiratory volume at the first second, forced vital capacity, and arterial blood gasses) were collected. Microbiota composition (CFU/ml), and intestinal permeability (i.e., Zonulin ng/ml) were measured in the stool and normalized to the normality cutoff value. RESULTS: All patients [n = 32, median age: 67 years, median RV: 185.0% pred (IQR: 162.0-206.0) and TLC 125.0% pred (IQR: 113.0-138.0)] showed depletion of Lactobacilli, Bacteroides and a great increase in E. Coli, KES (2 and 6.4 times) and Saccharomyces concentrations (2.5 times) other than normality. All evaluations on gut microbiota composition in the whole population were independent of BMI, CRF, GOLD stage or hyperinflation severity, and inhaled steroid therapy. Smoking habits (smokers vs ex-smokers) influenced only Bacteroides species (p<0.05) and no systemic inflammation was present in these patients. On the contrary, Zonulin concentration, a marker of intestinal permeability, was significantly higher than normal (2.8 times) and was correlated with Saccharomyces (p = 0.013). Zonulin (p = 0.001) and Saccharomyces (p<0.0001) were also significantly different in patients undergoing exercise training with respect to those on the waiting list for training. These findings were not influenced by smoking habits. CONCLUSIONS: A marked dysbiosis and leaky gut alteration characterize all COPD hyper-inflated patients, being worse in patients waiting for exercise training. A pre-to-post study is necessary to confirm these preliminary findings.

Predictors of survival in patients undergoing cardiac rehabilitation after transcatheter aortic valve replacement (TAVR): a multicenter retrospective study.

BACKGROUND: The aim of this study was to evaluate cardiac rehabilitation (CR)-derived predictors of outcome in patients discharged from rehabilitation after transcatheter aortic valve replacement (TAVR). METHODS: We retrospectively analyzed data from 232 TAVR patients (aged 82±6 years, 55% females) discharged following an average 3-week residential CR program in the period January 2009 to December 2017. Comorbidities (cumulative illness rated state-comorbidity index, CIRS-CI), echocardiography on admission, disability (Barthel Index [BI]) and functional capacity (6-min walk distance, 6MWD) at discharge, and maximal training session intensity expressed in METs/min were collected. The endpoint was all-cause mortality. RESULTS: Seventy-four (32%) deaths occurred at 3-year follow-up. At discharge, non-survivors had a higher comorbidity rate (CIRS-CI 5.2±2.3 vs. 4.1±1.9, P=0.000), higher disability level (BI 80.4±24 vs. 88.8±17, P=0.000), and worse renal function (creatinine 1.6±0.9 vs. 1.2±0.4 mg/dL, P=0.000). They were also more often on diuretics (73% vs. 53.2%, P=0.003) and beta-blocker therapy (73% vs. 57.6%, P=0.042) and had a markedly reduced functional capacity (6MWD 221±100m vs. 265±105m, P=0.001). At multivariate Cox proportional hazards regression analysis, independent predictors of survival at follow-up were lower comorbidity rate, a better-preserved renal function, lower use of diuretics, and a higher 6MWD at discharge (Harrell's C = 0.707). CONCLUSIONS: Patients attending residential CR after TAVR are very old with significant comorbidity. The overall 3-year mortality rate after CR discharge is high. Our findings suggest the need for individually tailored follow-up care in patients discharged from CR after TAVR to address their residual exercise capacity, comorbidities, and renal function impairment.

Definition of a Method for the Evaluation of Telemedicine Platforms in the Italian Context.

Background: The COVID-19 outbreak led to the diffusion of several telemedicine solutions. The choice of the correct platform is crucial for ensuring the release of effective assistance. However, there is a lack of an objective method for the assessment of technical features. Objective: This study proposes a methodology for the evaluation of functional requirements of telemedicine platforms. This approach also permits the comparison of solutions in the Italian market by means of defined parameters, thus directing the choice of health care professionals. Methods: The study is divided into three phases. First, a mapping of the telemedicine platforms operating in Italy is performed. Then, the available platforms are selected based on the offered telemedicine activity. Finally, a method for evaluating the investigated platforms is defined. Results: Thirty-three (n = 33) technological systems were identified through an accurate investigation on the web and interviews with IT companies. Fifteen parameters were defined and organized into three categories: (1) usability of the telemedicine platform, (2) security, and (3) technological and organizational aspects. A score between 1 and 4 was assigned to each parameter, proportionally to the completeness of the platform. In particular, 62.96% of platforms reached an average score between 3.01 and 4 points; 33.33% of them had scores between 2.01 and 3, while the remaining 3.70% of solutions obtained a result between 1.01 and 2. Conclusions: The study provides an evaluation approach that is easily usable by health professionals to select the most suitable platform. The number of solutions and quality of information could be updated to obtain a complete tool.

Feasibility of telepsychology support for patients with advanced cardiorespiratory diseases and their caregivers.

Objective: The aim of this study was to test the feasibility of telepsychology support for patients with severe cardiorespiratory disease and their caregivers. A secondary objective was to explore pre-post relationships between patients' and caregivers' clinical measures. Methods: A telehealth program incorporating telepsychology support, i.e., an "on-demand" phone service with a psychologist, was provided to consecutive cardiorespiratory patients at discharge from inpatient rehabilitation and to their caregivers. At the start and end of the 1-year program, participants were interviewed "face-to-face," and their anxiety/depression level, patients' quality of life (MRF-28, SF-36, and MQOL), and caregivers' (n = 18) family strain (FSQ) and needs (CNA) were assessed: we analyzed the correlations and evaluated customer satisfaction. Results: Of 80 eligible individuals, 40 took part in this study: 22 patients (FVC = 39 ± 14%; EF = 39 ± 13%) and 18 caregivers. Eleven (28%, 6 patients and 5 caregivers) requested tele-psychological support, resulting in 51 consultations focused on anxiety, difficulty in patient management, worry about the patient's emotional state, and need for emotional support; 3 participants underwent a tailored psychotherapy program. All participants expressed high satisfaction with the service. At enrolment, anxiety was less evident in patients (73% men) than in caregivers, while depressive symptoms were more evident (6.5 ± 3.1), and correlated with MRF-28 and MQOL. Caregivers' (94% women) FSQ showed a "strongly recommended" need for support; at enrolment, high levels of anxiety/depression were correlated with high FSQ (for both, p < 0.05); depressive symptoms correlated negatively with age (p = 0.025) and positively with emotional needs (p = 0.025); anxiety was positively correlated with education level (p = 0.048). At follow-up, patients' perception of support (n = 13/22) tended to increase (p = 0.089), while caregivers' strain (n = 10/18) tended to decline (to within the "range of attention"). At enrolment, caregivers' anxiety/depression and strain correlated with patients' quality of life (for both; p < 0.05). At follow-up, caregivers' strain correlated with patients' quality of life (p = 0.028) and cognitive performance (p = 0.048). Conclusion: Telepsychology support associated with a telehealth service is feasible and satisfying for both participants and psychological management. A suitable support program can benefit both patients and caregivers, particularly those at higher risk of depressive symptoms (younger caregivers) and anxiety (all caregivers).

Renin Angiotensin System Blockers and Risk of Mortality in Hypertensive Patients Hospitalized for COVID-19: An Italian Registry.

BACKGROUND: It is uncertain whether exposure to renin-angiotensin system (RAS) modifiers affects the severity of the new coronavirus disease 2019 (COVID-19) because most of the available studies are retrospective. METHODS: We tested the prognostic value of exposure to RAS modifiers (either angiotensin-converting enzyme inhibitors [ACE-Is] or angiotensin receptor blockers [ARBs]) in a prospective study of hypertensive patients with COVID-19. We analyzed data from 566 patients (mean age 75 years, 54% males, 162 ACE-Is users, and 147 ARBs users) hospitalized in five Italian hospitals. The study used systematic prospective data collection according to a pre-specified protocol. All-cause mortality during hospitalization was the primary outcome. RESULTS: Sixty-six patients died during hospitalization. Exposure to RAS modifiers was associated with a significant reduction in the risk of in-hospital mortality when compared to other BP-lowering strategies (odds ratio [OR]: 0.54, 95% confidence interval [CI]: 0.32 to 0.90, p = 0.019). Exposure to ACE-Is was not significantly associated with a reduced risk of in-hospital mortality when compared with patients not treated with RAS modifiers (OR: 0.66, 95% CI: 0.36 to 1.20, p = 0.172). Conversely, ARBs users showed a 59% lower risk of death (OR: 0.41, 95% CI: 0.20 to 0.84, p = 0.016) even after allowance for several prognostic markers, including age, oxygen saturation, occurrence of severe hypotension during hospitalization, and lymphocyte count (adjusted OR: 0.37, 95% CI: 0.17 to 0.80, p = 0.012). The discontinuation of RAS modifiers during hospitalization did not exert a significant effect (p = 0.515). CONCLUSIONS: This prospective study indicates that exposure to ARBs reduces mortality in hospitalized patients with COVID-19.

Telemedicine as a Means to an End, Not an End in Itself.

Telemedicine (TM)-the management of disease at a distance-has potential usefulness for patients with advanced respiratory disease. Underscoring this potential is the dramatic expansion of its applications in clinical medicine. However, since clinical studies testing this intervention often provide heterogeneous results, its role in the medical management of respiratory disorders remains inconclusive. A major problem in establishing TM's effectiveness is that it is not a single intervention; rather, it includes a number of divergent diagnostic and therapeutic modalities-and each must be tested separately. Reflecting the discord between the need for further documentation of its approaches and effectiveness and its rapid utilization without this needed information, a major challenge is the lack of international guidelines for its integration, regulation, operational plans, and guidance for professionals. Tailored TM, with increased flexibility to address differing healthcare contexts, has the potential to improve access to and quality of services while reducing costs and direct input by health professionals. We should view TM as a tool to aid healthcare professionals in managing their patients with respiratory diseases rather than as a stand-alone substitute to traditional medical care. As such, TM is a means rather than an end.

Association of improvement in functional capacity after rehabilitation with long-term survival in heart failure.

BACKGROUND: The prognostic value of change in six-minute walking distance (6MWD) after treatment to predict mortality in heart failure (HF) remains a controversial issue. We assessed the prognostic value of rehabilitation-induced improvement in 6MWD in predicting mortality in patients with HF. METHODS: We studied 2257 patients admitted to six inpatient rehabilitation facilities after a hospitalization for HF (N. 912) or because of worsening functional capacity and/or deteriorating clinical status (N. 1345). A six-minute walking test was performed at admission and discharge. The primary outcome was 3-year all-cause mortality after discharge from cardiac rehabilitation. We used multivariable Cox proportional hazard modeling to assess the association of increase in 6MWD with 3-year mortality, adjusting for established predictors of mortality. RESULTS: 6MWD significantly increased by 61 m (p < .001) from admission to discharge and 969 patients (42.9%) achieved an increase in 6MWD >50 m. After full adjustment, an increase in 6MWD >50 m was associated with a 22% decreased risk for 3-year mortality (HR 0.78 [95% CI 0.68-0.91]; p = .002). When modeled as a continuous variable, improvement in 6MWD remained independently associated with decreased risk for 3-year mortality (HR per each 50 m increase: 0.92 [95% CI 0.88-0.96]). CONCLUSIONS: Rehabilitation-induced improvement in 6MWD was associated with a significantly reduced risk for 3-year mortality. Our data also suggest that an improvement in 6MWD of more than 50 m could represent a clinically meaningful endpoint of cardiac rehabilitation for patients with heart failure.

Characteristics, Outcomes, and Long-Term Survival of Patients With Heart Failure Undergoing Inpatient Cardiac Rehabilitation.

OBJECTIVE: To investigate the association of cardiac rehabilitation (CR) participation with all-cause mortality after a hospitalization for heart failure (HF) and to describe the characteristics and functional and clinical outcomes of HF patients undergoing inpatient CR. DESIGN: Multicenter cohort study. The association between CR participation and all-cause mortality from discharge from the acute care setting was assessed using Cox regression analysis adjusting for established prognostic factors. SETTING: Six inpatient rehabilitation facilities. PARTICIPANTS: A total of 3219 patients with HF admitted to inpatient CR between January 2013 and December 2016. Of these patients, 1455 had been transferred directly from acute care hospitals after a hospitalization for HF (CR-group 1) and 1764 had been admitted from the community due to worsening functional disability or worsening clinical conditions (CR-group 2). Serving as a control group were 633 patients not referred to CR after a hospitalization for HF served as control group (non-CR group). INTERVENTIONS: Cardiac rehabilitation. MAIN OUTCOME MEASURES: Long-term mortality. Secondary outcomes were: (1) change in functional capacity, as assessed by change in 6-minute walking distance from admission to discharge; (2) clinical outcomes of the index inpatient rehabilitation admission, including in-hospital mortality and unplanned readmission to the acute care. RESULTS: Compared with the non-CR group, the adjusted hazard ratios of mortality at 1, 3, and 5 years for CR-group 1 patients were 0.82 (range, 0.68-0.97), 0.81 (range, 0.71-0.93), and 0.80 (range, 0.70-0.91). The 6-minute walking distance increased from 230-292 meters (P<.001), and 43.4% of the patients gained >50 m improvement. Overall, 2.5% of the patients died in hospital and 4.7% of the patients experienced unplanned readmissions to acute care, with significant differences between group 1 and group 2. CONCLUSIONS: Our data show that inpatient CR is effective in improving functional capacity and suggest that inpatient CR provided in the earliest period after a hospitalization for HF is associated with long-term improved survival.

Telehealth and Telecare: A Real-Life Integrated Experience in the COVID-19 Pandemic.

Background:In the first few months of 2020, Lombardy was the hardest-hit region in Italy for COVID-19 cases. Our Rehabilitation Institute offered a telemedicine service to COVID-19 patients discharged after hospitalization.Methods:Patients transferred from Emergency, Intensive Care, and Pulmonology departments of the principal regional hospital hubs had an average stay in our hospital of 2-3 weeks. On discharge, at home, they underwent a telecare nursing and specialist teleconsultation program for 3 months, including monitoring of vital signs and symptoms. Patients completed the SF-12 questionnaire at the start and end of the program and rated their satisfaction with it.Results:The program involved 130 patients (51%). During the period, there were 14 ± 2 (1,800 in total) telenursing support phone calls per patient made, and 12.5 ± 3.4 oxygen saturation readings per patient (1,631 in total). Persisting symptoms, frequently in combination, were present at the start of the program in 124 (94%) patients. There was a significant reduction of symptoms (p < 0.0000) after the telecare program. The physical component of SF-12 significantly improved at the end [Δ(t1-t0) = 6.7 ± 9.3, p < 0.0001]. On the contrary, the mental component of SF-12 remained unchanged or decreased slightly in patients ≤70 years of age [Δ(t1-t0) = -2.7 ± 12.3, ns], while it decreased significantly [Δ(t1-t0) = -5.4 ± 12.4, p = 0.0367] in older patients (although remaining mild). Patient satisfaction with the program was very high in all 130 patients.Conclusions:Our Telehealth and Telecare Service offers an example of rapid scaling and adaptation of an existing program to meet the needs of COVID-19 patients. Our findings indicate that telemedicine can be an integral part of clinical practice if supported by the institution with training and IT support provided to patients, nurses, and clinicians.

Brisk walking can be a maximal effort in heart failure patients: a comparison of cardiopulmonary exercise and 6 min walking test cardiorespiratory data.

AIMS: Cardiopulmonary exercise test (CPET) and 6 min walking test (6MWT) are frequently used in heart failure (HF). CPET is a maximal exercise, whereas 6MWT is a self-selected constant load test usually considered a submaximal, and therefore safer, exercise, but this has not been tested previously. The aim of this study was to compare the cardiorespiratory parameters collected during CPET and 6MWT in a large group of healthy subjects and patients with HF of different severity. METHODS AND RESULTS: Subjects performed a standard maximal CPET and a 6MWT wearing a portable device allowing breath-by-breath measurement of cardiorespiratory parameters. HF patients were grouped according to their CPET peak oxygen uptake (peakV̇O2 ). One hundred and fifty-five subjects were enrolled, of whom 40 were healthy (59 ± 8 years; male 67%) and 115 were HF patients (69 ± 10 years; male 80%; left ventricular ejection fraction 34.6 ± 12.0%). CPET peakV̇O2 was 13.5 ± 3.5 mL/kg/min in HF patients and 28.1 ± 7.4 mL/kg/min in healthy subjects (P < 0.001). 6MWT-V̇O2 was 98 ± 20% of the CPET peakV̇O2 values in HF patients, while 72 ± 20% in healthy subjects (P < 0.001). 6MWT-V̇O2 was >110% of CPET peakV̇O2 in 42% of more severe HF patients (peakV̇O2  < 12 mL/kg/min). Similar results have been found for ventilation and heart rate. Of note, the slope of the relationship between V̇O2 at 6MWT, reported as a percentage of CPET peakV̇O2 vs. 6MWT V̇O2 reported as the absolute value, progressively increased as exercise limitation did. CONCLUSIONS: In conclusion, the last minute of 6MWT must be perceived as a maximal or even supramaximal exercise activity in patients with more severe HF. Our findings should influence the safety procedures needed for the 6MWT in HF.

The Future of Exercise-Based Cardiac Rehabilitation for Patients With Heart Failure.

Cardiac rehabilitation (CR) is a comprehensive program that includes exercise training, titration of medical therapy, lifestyle modification, educational support, and psychosocial assessment. All these components are safe and beneficial resulting in significant improvements in quality of life, functional capacity, mortality, and hospital readmission. Current guidelines support its use in a broad spectrum of cardiac disease. This review focuses on exercise-based CR for heart failure (HF) patients in whom CR is a recommended treatment. Exercise should be prescribed according to a personalized approach, optimizing, and tailoring the rehabilitative program to the patient's characteristics. Specific CR programs are dedicated to older patients, those with HF and preserved ejection fraction, and recipients of cardiac implantable electronic devices or left ventricular assistance device. Telemedicine may increase CR participation and overcome some of the barriers that limit its utilization.

Altered Vascular Endothelium-Dependent Responsiveness in Frail Elderly Patients Recovering from COVID-19 Pneumonia: Preliminary Evidence.

We evaluated vascular dysfunction with the single passive leg movement test (sPLM) in 22 frail elderly patients at 84 + 31 days after hospitalization for COVID-19 pneumonia, compared to 22 age-, sex- and comorbidity-matched controls (CTRL). At rest, all COVID-19 patients were in stable clinical condition without severe comorbidities. Patients (aged 72 ± 6 years, 73% male) had moderate disability (Barthel index score 77 ± 26), hypoxemia and normocapnia at arterial blood gas analysis and mild pulmonary restriction at spirometry. Values of circulating markers of inflammation (C-reactive protein: CRP; erythrocyte sedimentation rate: ESR) and coagulation (D-dimer) were: 27.13 ± 37.52 mg/dL, 64.24 ± 32.37 mm/1 h and 1043 ± 729 ng/mL, respectively. At rest, femoral artery diameter was similar in COVID-19 and CTRL (p = 0.16). On the contrary, COVID-19 infection deeply impacted blood velocity (p = 0.001) and femoral blood flow (p < 0.0001). After sPLM, peak femoral blood flow was dramatically reduced in COVID-19 compared to CTRL (p = 0.001), as was blood flow ∆peak (p = 0.05) and the area under the curve (p < 0.0001). This altered vascular responsiveness could be one of the unknown components of long COVID-19 syndrome leading to fatigue, changes in muscle metabolism and fibers' composition, exercise intolerance and increased cardiovascular risk. Impact of specific treatments, such as exercise training, dietary supplements or drugs, should be evaluated.