The Exercise aNd hEArt transplant (ENEA) trial - a registry-based randomized controlled trial evaluating the safety and efficacy of cardiac telerehabilitation after heart transplant.

BACKGROUND: Heart transplant (HTx) is gold-standard therapy for patients with end-stage heart failure. Cardiac rehabilitation (CR) is a multidisciplinary intervention shown to improve cardiovascular prognosis and quality of life. The aim in this randomized controlled trial is to explore the safety and efficacy of cardiac telerehabilitation after HTx. In addition, biomarkers of rehabilitation outcomes will be identified, as data that will enable treatment to be tailored to patient phenotype. METHODS: Patients after HTx will be recruited at IRCCS S. Maria Nascente - Fondazione Don Gnocchi, Milan, Italy (n = 40). Consenting participants will be randomly allocated to either of two groups (1:1): an intervention group who will receive on-site CR followed by 12 weeks of telerehabilitation, or a control group who will receive on-site CR followed by standard homecare and exercise programme. Recruitment began on 20th May 2023 and is expected to continue until 20th May 2025. Socio-demographic characteristics, lifestyle, health status, cardiovascular events, cognitive function, anxiety and depression symptoms, and quality of life will be assessed, as well as exercise capacity and muscular endurance. Participants will be evaluated before the intervention, post-CR and after 6 months. In addition, analysis of circulating extracellular vesicles using Surface Plasmon Resonance imaging (SPRi), based on a rehabilomic approach, will be applied to both groups pre- and post-CR. CONCLUSION: This study will explore the safety and efficacy of cardiac telerehabilitation after HTx. In addition, a rehabilomic approach will be used to investigate biomolecular phenotypization in HTx patients. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT05824364.

Characteristics, Components, and Efficacy of Telerehabilitation Approaches for People with Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is at the top of the list of non-communicable diseases with related rehabilitation needs. Digital medicine may provide continuative integrated intervention, overcoming accessibility and cost barriers. METHODS: We systematically searched for randomized controlled trials on telerehabilitation (TR) in people with COPD to profile the adopted TR strategies, focusing on TR models and the main rehabilitation actions: monitoring and assessment, decision, and feedback. Additionally, a meta-analysis was run to test the TR effect on functional capacity, dyspnea, and quality of life compared to no intervention (NI) and conventional intervention (CI). RESULTS: Out of the 6041 studies identified, 22 were eligible for the systematic review, and 14 were included in the meta-analyses. Results showed a heterogeneous scenario in terms of the TR features. Furthermore, only a small group of trials presented a comprehensive technological kit. The meta-analysis highlighted a significant effect of TR, especially with the asynchronous model, on all outcomes compared to NI. Moreover, a non-inferiority effect of TR on functional capacity and quality of life, and a superiority effect on dyspnea compared to CI were observed. Finally, the studies suggested a high rate of TR adherence and high safety level. CONCLUSIONS: TR is an effective strategy to increase and maintain functional capacity, breath, and quality of life in people with COPD. However, a consensus on the essential elements and features of this approach needs to be defined, and the effect of long-term maintenance merits further investigation.

Can Seismocardiogram Fiducial Points Be Used for the Routine Estimation of Cardiac Time Intervals in Cardiac Patients?

The indexes of cardiac mechanics can be derived from the cardiac time intervals, CTIs, i.e., the timings among the opening and closure of the aortic and mitral valves and the Q wave in the ECG. Traditionally, CTIs are estimated by ultrasound (US) techniques, but they may also be more easily assessed by the identification of specific fiducial points (FPs) inside the waveform of the seismocardiogram (SCG), i.e., the measure of the thorax micro-accelerations produced by the heart motion. While the correspondence of the FPs with the valve movements has been verified in healthy subjects, less information is available on whether this methodology may be routinely employed in the clinical practice for the monitoring of cardiac patients, in which an SCG waveform distortion is expected because of the heart dysfunction. In this study we checked the SCG shape in 90 patients with myocardial infarction (MI), heart failure (HF), or transplanted heart (TX), referred to our hospital for rehabilitation after an acute event or after surgery. The SCG shapes were classified as traditional (T) or non-traditional (NT) on whether the FPs were visible or not on the basis of nomenclature previously proposed in literature. The T shape was present in 62% of the patients, with a higher ∓ prevalence in MI (79%). No relationship was found between T prevalence and ejection fraction (EF). In 20 patients with T shape, we checked the FPs correspondence with the real valve movements by concomitant SCG and US measures. When compared with reference values in healthy subjects available in the literature, we observed that the Echo vs. FP differences are significantly more dispersed in the patients than in the healthy population with higher differences for the estimation of the mitral valve closure (-17 vs. 4 ms on average). Our results indicate that not every cardiac patient has an SCG waveform suitable for the CTI estimation, thus before starting an SCG-based CTI monitoring a preliminary check by a simultaneous SCG-US measure is advisable to verify the applicability of the methodology.

Telerehabilitation Approaches for People with Chronic Heart Failure: A Systematic Review and Meta-Analysis.

INTRODUCTION: Telerehabilitation (TR) for chronic heart failure (CHF) allows for overcoming distance barriers and reducing exacerbations. However, little is known about TR descriptors, components, and efficacy in CHF. METHODS: This work systematically reviewed the TR strategies of randomized controlled trials in people with CHF. A meta-analysis was run to test its effect on exercise capacity and quality of life compared to no rehabilitation (NI) and conventional intervention (CI). RESULTS: Out of 6168 studies, 11 were eligible for the systematic review, and 8 for the meta-analysis. TR intervention was individual and multidimensional, with a frequency varying from 2 to 5 times per 8-12 weeks. The TR components mainly included an asynchronous model, monitoring/assessment, decision, and offline feedback. A few studies provided a comprehensive technological kit. Minimal adverse events and high adherence were reported. A large effect of TR compared to NI and a non-inferiority effect compared to CI was registered on exercise capacity, but no effects of TR compared to NI and CI on quality of life were observed. CONCLUSIONS: TR for people with CHF adopted established effective strategies. Future interventions may identify the precise TR dose for CHF, technological requirements, and engagement components affecting the patient's quality of life.

Short- and long-term effects of a cardiac rehabilitation program in patients implanted with a left ventricular assist device.

The efficacy of cardiac rehabilitation in heart-failure patients who received a left-ventricular assist device (LVAD) instead of heart transplantation (HTx) is still unclear. This study aims to evaluate whether cardiac rehabilitation is beneficial in LVAD as HTx patients in the short term and whether its effects in LVAD patients persist over time. Twenty-five LVAD patients were evaluated by functional and psychological tests at admission (T0) and discharge (T1) of a 4-week inpatient structured rehabilitation program, and follow-ups 3 (T2), 6 (T3), and 12 months (T4) after discharge. Twenty-five matched HTx patients were also studied from T0 to T1 to compare the improvements in the six-minute walk test (6MWT). The quality-of-life scores substantially improved in LVAD patients and the 6MWT showed the same functional recovery as in HTx patients from T0 to T1. After T1, numerous LVAD patients withdrew from the study. However, the 6MWT outcome increased further from T1 to T3, with a positive trend during the follow-ups. Hemoglobin and the ventilatory performance increased, and the psychological perception of heart-failure symptoms and pain further improved at T2. In conclusion, exercise-based rehabilitation programs provide similar beneficial effects in LVAD and HTx patients, without deterioration in LVAD patients up to 12 months after discharge.

[Referral to cardiac rehabilitation of patients with left ventricular assist devices in Italy]. / Ricoveri in riabilitazione cardiologica dei pazienti sottoposti ad impianto di assistenza ventricolare sinistra in Italia.

In recent years, the lack of heart donors caused an increase in the proportion of patients undergoing left ventricular assist device (LVAD) implantation. The clinical complexity of these devices requires a multidisciplinary approach to be extended after hospital discharge. The lack of shared care pathways for these patients may result in an impairment of both of short- and long-term results. Available data show that cardiac rehabilitation (CR) improves physical performance and quality of life. Notwithstanding this, there is a lack of information about its effects on mortality, hospitalizations and major complications. This article is a survey focus on the referral to CR facilities and the number and types of LVAD implanted in Italy. Among the 24 Italian cardiac surgery centers that have been contacted, 22 provided their data: from 2012 to 2014, 260 patients underwent LVAD implantation with an in-hospital post-surgical mortality of 10%, and 77% of patients were admitted to CR facilities. For patients with LVAD, a referral to an inpatient rehabilitation unit may be considered appropriate.

Psychological profiles derived by cluster analysis of Minnesota Multiphasic Personality Inventory and long term clinical outcome after coronary artery by pass grafting.

BACKGROUND: To evaluate the psychological characteristics of coronary heart disease (CHD) patients after coronary artery bypass grafting (CABG) by cluster analysis of Minnesota Multiphasic Personality Inventory (MMPI-2) questionnaires and to assess the impact of the profiles obtained on long-term outcome. METHODS: 229 CHD patients admitted to cardiac rehabilitation filled in self-administered MMPI-2 questionnaires early after CABG. We assessed the relation between MMPI-2 profiles derived by cluster analysis, clinical characteristics and outcome at 3-year follow-up. RESULTS: Among the 215 patients (76% men, median age 66 years) with valid criteria in control scales, we identified 3 clusters (G) with homogenous psychological characteristics: G1 patients (N = 75) presented somatoform complaints but overall minimal psychological distress. G2 patients (N=72) presented type D personality traits. G3 subjects (N=68) showed a trend to cynicism, mild increases in anger, social introversion and hostility. Clusters overlapped for clinical characteristics such as smoking (G1 21%, G2 24%, G3 24%, p ns), previous myocardial infarction (G1 43%, G2 47%, G3 49% p ns), LV ejection fraction (G1 60 [51-60]; G2 58 [49-60]; G3 60 [55-60], p ns), 3-vessel-disease prevalence (G1 69%, G2 65%, G3 71%, p ns). Three-year event rates were comparable (G1 15%; G2 18%; G3 15%) and Kaplan-Meier curves overlapped among clusters (p ns). CONCLUSIONS: After CABG, the interpretation of MMPI-2 by cluster analysis is useful for the psychological and personological diagnosis to direct psychological assistance. Conversely, results from cluster analysis of MMPI-2 do not seem helpful to the clinician to predict long term outcome.

Psychological disorders after coronary artery by-pass surgery: a one-year prospective study.

BACKGROUND: Coronary artery by-pass surgery (CABG) is often followed by anxiety and depression that require early identification in order to provide adequate psychological support. The predictive role of tests administered soon after CABG on long-term psychological outcomes has been only incompletely explored. AIM, DESIGN AND METHODS: Aim of this study was to assess post-operative and 12-month persistence of psychological disorders by means of the Minnesota Multiphasic Personality Inventory (MMPI-2) and the depression and state and trait anxiety scales of the Cognitive Behavioural Assessment (CBA-2.0) in 118 male patients admitted to cardiac rehabilitation after CABG. RESULTS: Early after CABG we observed a high prevalence of depression (11.8% by MMPI-2 and 12.7% by CBA) and state anxiety (23.5%). At 1-year the MMPI-2 scale D indicated stable mean score and high scores at entry were predictive of persistent depression. Conversely the CBA-2.0 scale QD score significantly decreased (from 3.86 +/- 3.19 to 2.91 +/- 3.45, p = 0.017). Also ST1 state anxiety significantly decreased (from 35.17 +/- 6.95 to 32.55 +/- 6.72, p = 0.003) whereas ST2 trait anxiety was stable. We found no association between psychometric results and ventricular function, number of grafts or time since diagnosis of coronary artery disease. CONCLUSIONS: State anxiety and depression by CBA significantly decreased 1-year after CABG; conversely trait anxiety and depression, investigated by MMPI-2, a more specific personality questionnaire, were stable. High scores for the depression in the scale D of MMPI-2 early after CABG seem to be predictive of the persistence of the disorder at 1-year.

[Coronary flow reserve assessment by transthoracic color Doppler echocardiography after primary angioplasty: relationship with recovery of left ventricular function]. / Valutazione della riserva di flusso coronarico mediante ecocardiografia color Doppler transtoracica in pazienti sottoposti ad angioplastica primaria: relazioni con il recupero della funzione ventricolare sinistra.

BACKGROUND: The aim of this study was to determine the relationship between coronary flow reserve measurement by transthoracic Doppler echocardiography in recent acute myocardial infarction treated with primary coronary angioplasty (PTCA) and recovery of left ventricular function. METHODS: Forty-one consecutive patients (3 patients excluded for not good quality of the Doppler signal) have been studied with: (1) recent first acute myocardial infarction treated with primary PTCA within 6 hours of pain onset; (2) optimal angioplasty result with stent deployment, anti-IIb/IIIa infusion and TIMI 3 flow; (3) lack of type 1 diabetes and/or hypertension; (4) good tolerance to adenosine. Transthoracic Doppler echocardiography was used to record coronary flow velocities in the distal left anterior descending and posterior descending coronary arteries at rest and after infusion of adenosine. Coronary flow reserve was measured after 11 +/- 1 days from the acute event. The wall motion score index (WMSI) was calculated at baseline, 1 month and 3 months from myocardial infarction. RESULTS: Patients of group A (n = 29 with coronary flow reserve > or = 1.6) showed a progressive and significant recovery of left ventricular function at follow-up. Patients of group B (n = 9 with coronary flow reserve < 1.6) had persistent left ventricular dysfunction at 3 months (ANOVA, p < 0.0001). WMSI was 1.64 +/- 0.26 in group A and 1.81 +/- 0.16 in group B (p = 0.09) at baseline; 1.30 +/- 0.26 in group A and 1.75 +/- 0.16 in group B (p < 0.0001) at 1 month; and 1.20 +/- 0.25 in group A and 1.73 +/- 0.17 in group B at 3 months. There was an inverse correlation between coronary flow reserve and WMSI at 1 month (r = -0.564, p < 0.0001), and at 3 months (r = -0.583, p < 0.0001). On multivariate analysis baseline WMSI and coronary flow reserve were the only predictors of 1-month WMSI recovery and of WMSI recovery at 3 months. CONCLUSIONS: Coronary flow reserve by transthoracic color Doppler echocardiography is a useful method for predicting left ventricular function recovery in patients after primary PTCA.

[Complexity of observable psychological distress after surgical myocardial revascularization in male subjects]. / Complessità dei disturbi psicologici osservabili dopo rivascolarizzazione miocardica chirurgica in soggetti di sesso maschile.

BACKGROUND: Psychological disturbances like anxiety, depression, post-traumatic stress disorder are often associated with coronary artery disease and, in some studies, play a prognostic role after a coronary event. Despite some psychological disturbances following coronary artery bypass graft (CABG) have an impact on outcomes of both the surgical intervention and the rehabilitation program, their complexity as well as their clinical and instrumental determinants are still not fully understood. The aim of this study was to determine in male subjects with coronary artery disease the prevalence and complexity of psychological disturbances occurring after CABG as well as their predictors. METHODS: One hundred eighteen males without history of psychological disturbances consecutively admitted to our rehabilitation inpatient service between September 2002 and September 2003 underwent 11 +/- 2 days after CABG extensive psychometric testing including the Minnesota Multiphasic Personality Inventory-2, the Cognitive Behavioral Assessment.2, and the Hamilton test. Cardiac evaluation included coronary risk factors, NYHA class, coronary heart disease history, medical therapy, CABG number, and echocardiography. RESULTS: Mean age 63.7 +/- 8.1 years; ejection fraction 54.6 +/- 10.3%; NYHA class I 92.4%, NYHA class II and III 7.6%; CABG number 1 (11%), 2 (23.7%), 3 (39.8%), 4 (21.8%), 5 (4.2%); coronary artery disease length 64 +/- 85 months, hospital stay 31.3 +/- 8 days. The score was above clinical cut-off on scale for depression in 16-39.8% of the patients, state anxiety in 27.1%, trauma in 16.1%, type A personality in 16.1%. Subjects above clinical cut-off for depression, anxiety and trauma did not differ from subjects below in terms of clinical and instrumental characteristics. Age, ejection fraction, coronary risk factors, coronary heart disease duration, and CABG number did not predict the development of depression, anxiety and trauma. Psychological disturbances often clustered in the same subjects. CONCLUSIONS: In males following CABG, psychological disturbances are extremely frequent, often clustered, and independent of subjects' characteristics and coronary heart disease severity.

[Resection of unusual atrial mass complicated with fungal endocarditis in a patient undergoing immunosuppressive treatment]. / Resezione di una neoformazione atriale rara complicata da endocardite fungina in paziente in terapia immunosoppressiva.

Nodules of mesothelial and monocytic cells (Mesothelial/Monocytic Incidental Cardiac Excresences; MICE) are rare cardiac lesions, non neoplastic, possibly reactive and in part derived from mesothelium. A 76 years old woman, treated with low dose of steroid and methotrexate for rheumatoid arthritis, underwent surgical excision of cardiac "MICE". Postoperative period was complicated with early and severe fungal endocarditis requiring reintervention. Two aspects are of interest: rarity of both cardiac pathologies and the possible relation to immunosuppressive therapy. Treatment of fungal endocarditis should be aggressive, overall survival is rather poor. Possibility to discontinue immunosuppressive treatment should be considered before cardiac surgery.

[Clinical and organizational problems related to cardiological rehabilitation units]. / Problematiche cliniche e gestionali della riabilitazione cardiologica in regime di ricovero.

The characteristics of patients admitted to cardiac rehabilitation units have progressively changed and are now represented by older age and clinical instability, with a higher percentage of females than in the past. Moreover, the demand of admission to cardiac rehabilitation departments has increased as a consequence of the extension of cardiac surgical procedures to older patients with frequent comorbidity. At the same time, the need of a shorter hospitalization in the acute hospital units has contributed to more frequent requests for cardiac rehabilitation admission. Cost factors and problems of organization have also contributed to the typology of the patients now admitted for cardiac rehabilitation. The data of patients admitted to the Cardiac Rehabilitation Unit of the Don Gnocchi Hospital in Milan are reported too: these data confirm the actual change in the typology of patients with respect to the past; the possible explanations and reasons, as well as the increased average age of the population and the increased number of surgical interventions in the elderly and females are also evaluated. Moreover, the programs and the rehabilitative aims have been consequently changed. Finally, even the use of non-invasive alternatives to ergometric tests is here discussed.