Coping, Mood, Quality of Life, and Outcomes in Recipients of Left Ventricular Assist Devices: A Cluster Analysis.

OBJECTIVE: Left ventricular assist devices (LVADs) are increasingly used for temporary circulatory support until transplant or as destination therapy for patients with end-stage heart failure. Understanding patients' attitudes and resources is crucial to support them. METHODS: Sixty-one LVAD recipients (55 [10] years, 10% women, 15% destination therapy) participating in cardiac rehabilitation (CR) postimplant underwent assessment of coping styles (Coping Orientation for Problem Experiences), quality of life (Medical Outcomes Study Short-Form 36, Minnesota Living with Heart Failure Questionnaire), and mood (Hospital Anxiety and Depression Scale). RESULTS: Cluster analysis identified two homogeneous groups: C1 (n = 18) patients had higher anxiety (9.6 [5.0] versus 4.0 [2.7], p < .001), depression (10 [3.0] versus 4 [2.7], p < .001), and avoidant coping (29 [5.2] versus 21.2 [3.8], p < .001) scores and worse quality of life (Short-Form 36 of the Medical Outcomes Study Physical Component Scale 31 [5.3] versus 35.6 [6.9], p < .001; Mental Component Scale 34.3 [6.8] versus 50.3 [8], p < .001; MLHFQ physical 26 [7.2] versus 13.9 [8.2], p < .001; emotional 17.7 [3.4] versus 3.86 [3.2], p < .001) than C2 participants (n = 43). During 31 (15-54) months, 20 patients (33%) died. By Cox multivariable analysis, after adjustment for age, sex, Interagency Registry for Mechanically Assisted Circulatory Support level at surgery, and meters walked during 6 minutes at CR discharge, C1 was associated with mortality (hazard ratio = 2.858; 95% confidence interval = 1.102-7.408, p = .031; model χ = 7.286, df = 5, p = .20). Survival was 44% in C1 and 77% in C2 (log-rank p = .033). CONCLUSIONS: Among patients discharged from CR after LVAD implant, one third show a profile characterized by worse perceived quality of life, mood disorders, and dysfunctional coping that is associated with long-term mortality, and these factors are potential targets for post-LVAD intensive support.

Psychological Profile in Coronary Artery By-Pass Graft Patients vs. Valve Replacement Patients Entering Cardiac Rehabilitation after Surgery.

Anxiety and depression are thought to influence the genesis of ischemic diseases and not of valvular diseases, but little is known on the psychological profile of cardiac patients after surgery. Aim of this study was to investigate differences in disease experience and mood between patients undergoing cardiac rehabilitation after coronary artery by-pass graft (CABG) or after valve replacement (VR). We studied 1,179 CABG and 737 VR patients who completed the Illness Behaviour Questionnaire and the Hospital Anxiety and Depression Scale after surgery. We tested the independent effect of the type of surgery by multivariate analysis and between-group differences in prevalence of clinically relevant scores. Relevant scores in the psychosomatic concern scale were more frequent in CABG than in VR patients. After correction by age, sex, education and marital status, scores of disease conviction and psychosomatic concern were higher in CABG patients, scores of denial were higher in VR patients. Unexpectedly, anxiety and depression scores did not differ between groups. Results suggest providing psychological support for anxiety and depression to both VR and CABG patients during cardiac rehabilitation, and planning differentiated interventions of cardiac rehabilitation and secondary prevention tailored to the specific psychological reactions of CABG and VR patients.

Differences in biochemical markers between Heart-transplanted and Left Ventricular Assist Device implanted patients, during cardiac rehabilitation.

Heart transplant (HTx) and left ventricular assist device (LVAD) implant are the best options for symptomatic end stage heart failure, but LVAD patients show lower rehabilitative outcome than HTx patients. To investigate the causes, we compared biomarkers levels and their association with rehabilitative outcome in 51 HTx and in 46 LVAD patients entering the same cardiac rehabilitation program. In both groups, routine biomarkers were measured at start (T1) and end (T2) of cardiac rehabilitation while homocysteine, leptine and IGF-1 were measured at T1 only. HTx patients had lower lymphocyte, platelets, glucose, total proteins and albumin at T1; differences with LVAD patients vanished during rehabilitation when new cases of diabetes were observed in HTx. By contrast, total cholesterol, LDL and HDL fractions, leptin and IGF-1 were higher in HTx patients. The increase from T1 to T2 in six-minute walking test distance, measure of functional rehabilitation outcome, was positively associated with homocysteine and IGF-1 levels in HTx patients. In conclusion, during rehabilitation care should be paid to the early occurrence of dyslipidemia and hyperglycemia in HTx patients, which also require a proper protein dietary support. IGF-1, dangerously low in LVAD patients, might contribute to their lower rehabilitative outcome.

Promotion of Home-Based Exercise Training as Secondary Prevention of Coronary Heart Disease: A PILOT WEB-BASED INTERVENTION.

BACKGROUND: Although cardiac rehabilitation (CR) is cost- effective in improving the health of patients with coronary heart disease (CHD), less than half of eligible CHD patients attend a CR program. Innovative web-based technologies might improve CR delivery and utilization. We assessed the feasibility and impact on functional capacity and secondary prevention targets of a long-term web-monitored exercise-based CR maintenance program. METHODS: Low- to moderate-risk CHD patients were recruited at discharge from inpatient CR after a coronary event or revascularization. We developed an interactive web-based platform for secure home individual access control, monitoring, and validation of exercise training. Of 86 eligible patients, 26 consented to participate in the study intervention (IG). Using a quasi-experimental design, we recruited in parallel 27 eligible patients, unavailable for regular web monitoring, who consented to a follow-up visit as usual care (UC). RESULTS: Among IG, active daily data transmission was 100% during month 1, 88% at month 3, and 81% at 6 months, with sustained improvement in self-reported physical activity beginning with the first week after discharge from inpatient CR (2467 [1854-3554] MET-min/wk) to month 3 (3411 [1981-5347] MET-min/wk, P = .019). Both groups showed favorable changes over time in lipid profile, ventricular function, distance walked in 6 min, and quality of life. At 6 mo, IG achieved a significantly higher proportion of cardiovascular risk factor targets than UC (75 ± 20% vs 59 ± 30%, P = .029). CONCLUSIONS: Our web-based home CR maintenance program was feasible, well-accepted, and effective in improving physical activity during 6 mo and achieved higher overall adherence to cardiovascular risk targets than UC.

End-stage heart failure: Two surgical approaches with different rehabilitative outcomes.

BACKGROUND: A rising number of patients are surgically treated for heart failure at the more advanced stage, thanks to the increasing use of left ventricular assist device (LVAD) as a reliable alternative to heart transplantation (HTx). However, it is still unknown whether differences exist between the two surgical approaches in the efficacy of rehabilitation programmes. Therefore, aim of this study was to evaluate whether functional capacity and rehabilitative outcomes differ between HTx and implantation of LVAD. METHODS AND RESULTS: We enrolled 51 patients with HTx and 46 with LVAD upon admission to our rehabilitation-unit. We evaluated six-minute walking test (6MWT), resting oxygen saturation (SaO2) and nutritional assessment before and after a standardised cardiovascular rehabilitation programme. HTx and LVAD groups differed in age, anthropometric variables, gender distribution. Upon enrolment, 6MWT distance was similar in the two groups, whereas malnutrition was less frequent and the waist circumference/height ratio (WHtR) was greater in LVAD patients. SaO2 was greater in HTx patients. Rehabilitation improved SaO2, 6MWT distance and nutritional status. The difference in malnutrition disappeared, but WHtR remained higher in the LVAD and SaO2 higher in the HTx patients; the 6MWT distance improved more in the HTx patients. Multivariate linear regression analysis confirmed that the type of intervention was independent predictor of 6MWT distance after rehabilitation. CONCLUSIONS: HTx patients improve more rapidly and perform better after rehabilitation, suggesting the need for more tailored rehabilitation training for LVAD patients.

Pilot Test of a New Personal Health System Integrating Environmental and Wearable Sensors for Telemonitoring and Care of Elderly People at Home (SMARTA Project).

BACKGROUND: The increase in life expectancy is accompanied by a growing number of elderly subjects affected by chronic comorbidities, a health issue which also implies important socioeconomic consequences. Shifting from hospital or community dwelling care towards a home personalized healthcare paradigm would promote active aging with a better quality of life, along with a reduction in healthcare-related costs. OBJECTIVE: The aim of the SMARTA project was to develop and test an innovative personal health system integrating standard sensors as well as innovative wearable and environmental sensors to allow home telemonitoring of vital parameters and detection of anomalies in daily activities, thus supporting active aging through remote healthcare. METHODS: A first phase of the project consisted in the definition of the health and environmental parameters to be monitored (electrocardiography and actigraphy, blood pressure and oxygen saturation, weight, ear temperature, glycemia, home interaction monitoring - water tap, refrigerator, and dishwasher), the feedbacks for the clinicians, and the reminders for the patients. It was followed by a technical feasibility analysis leading to an iterative process of prototype development, sensor integration, and testing. Once the prototype had reached an advanced stage of development, a group of 32 volunteers - including 15 healthy adult subjects, 13 elderly people with cardiac diseases, and 4 clinical operators - was recruited to test the system in a real home setting, in order to evaluate both technical reliability and user perception of the system in terms of effectiveness, usability, acceptance, and attractiveness. RESULTS: The testing in a real home setting showed a good perception of the SMARTA system and its functionalities both by the patients and by the clinicians, who appreciated the user interface and the clinical governance system. The moderate system reliability of 65-70% evidenced some technical issues, mainly related to sensor integration, while the patient's user interface showed excellent reliability (100%). CONCLUSIONS: Both elderly people and clinical operators considered the SMARTA system a promising and attractive tool for improving patients' healthcare while reducing related costs and preserving quality of life. However, the moderate reliability of the system should prompt further technical developments in terms of sensor integration and usability of the clinical operator's user interface.

Osteopathic Manipulative Treatment Improves Heart Surgery Outcomes: A Randomized Controlled Trial.

BACKGROUND: Controlling sternal pain after heart surgery is important to reduce the risk of postoperative complications, but pain is often undertreated because of contraindications and side effects of analgesic drugs. Recently, osteopathic manipulative treatment (OMT) was demonstrated to reduce pain in different clinical contexts, suggesting its potential utility after cardiac surgery. The aim of this open-label, controlled study is to assess whether OMT contributes to sternal pain relief and improves postoperative outcomes. METHODS: Eighty post-sternotomy adult inpatients were randomly allocated one to one to receive a standardized cardiorespiratory rehabilitation program alone (control group) or combined with OMT. Pain intensity and respiratory functional capacity were quantified by the Visual Analogue Scale score and by a standardized breathing test, at the start and end of rehabilitation. RESULTS: At the start of rehabilitation, the control group and the OMT group had similar Visual Analogue Scale median scores (controls 4, interquartile range [IQR]: 2 to 5; OMT 4, IQR: 3 to 5; p = not significant) and mean inspiratory volumes (controls 825 ± 381 mL; OMT 744 ± 291 mL; p = not significant). At the end of rehabilitation, the OMT group had a lower Visual Analogue Scale median score (controls 3, IQR: 2 to 4; OMT 1, IQR: 1 to 2; p < 0.01) and higher mean inspiratory volume (controls 1,400 ± 588 mL; OMT 1,781 ± 633 mL; p < 0.01). The analgesic drug intake was similar in the two groups. The hospitalization was shorter in the OMT group than in the control group (19.1 ± 4.8 versus 21.7 ± 6.3 days; p < 0.05). CONCLUSIONS: The combination of standard care with OMT is effective in inducing pain relief and functional recovery, and significantly improves the management of patients after heart surgery with sternotomy.

[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.

Fingolimod effects on left ventricular function in multiple sclerosis.

BACKGROUND: Cardiovascular side effects such as bradycardia and atrioventricular block were observed during the early clinical trials of fingolimod in multiple sclerosis, and one cardiovascular- linked death has been reported in the post-marketing period. OBJECTIVE: To investigate the medium-term effects of fingolimod on heart function in order to obtain further insights into its cardiac safety profile. METHODS: The study involved 53 patients starting treatment with fingolimod 0.5 mg daily and 25 patients treated with natalizumab 300 mg monthly. Cardiac function was assessed by means of echocardiography at baseline (T0), and after one (T1), six (T6), and (in the case of the fingolimod group) 12 months (T12). RESULTS: Mean left ventricular ejection fraction significantly decreased and end-systolic volume increased from T0 to T1 (p=0.005) and T6 (p=0.0001) in the fingolimod but not the natalizumab group, although a slight increase was observed at T12. A similar decrease in ejection fraction was also observed after six months in nine patients switched from natalizumab to fingolimod. CONCLUSION: Fingolimod significantly reduces left ventricular systolic function in MS patients. This effect has no clinical consequences in subjects without previous cardiac disorders, but suggests that more caution is required in patients with current or previous heart failure.

Quality of life and emotional distress early after left ventricular assist device implant: a mixed-method study.

Patients who temporarily or permanently rely on left ventricular assist devices (LVADs) for end-stage heart failure face complex psychological, emotional, and relational problems. We conducted a mixed-method study to investigate quality of life, psychological symptoms, and emotional and cognitive reactions after LVAD implant. Twenty-six patients admitted to cardiac rehabilitation were administered quality of life questionnaires (Short Form 36 of the Medical Outcomes Study and Minnesota Living with Heart Failure Questionnaire), the Hospital Anxiety and Depression Scale, and the Coping Orientation for Problem Experiences inventory, and underwent three in-depth unstructured interviews within 2 months after LVAD implant. Quality of life assessment (Short Form 36) documented persistently low physical scores whereas mental component scores almost achieved normative values. Clinically relevant depression and anxiety were observed in 18 and 18% of patients, respectively; avoidant coping scores correlated significantly with both depression and anxiety (Pearson correlation coefficients 0.732, P < 0.001 and 0.764, P < 0.001, respectively). From qualitative interviews, factors that impacted on LVAD acceptance included: device type, disease experience during transplant waiting, nature of the assisted organ, quality of patient-doctor communication, the opportunity of sharing the experience, and recipient's psychological characteristics. Quality of life improves early after LVAD implant, but emotional distress may remain high. A multidimensional approach that takes into account patients' psychological characteristics should be pursued to enhance LVAD acceptance.

Gender differences in illness behavior after cardiac surgery.

PURPOSE: Differences in the ways male and female patients confront their illness after cardiac surgery may contribute to previously observed gender differences in the outcomes of cardiac rehabilitation. The aim of this cross-sectional study was to verify whether there are gender-related differences in illness behavior (IB) soon after cardiac surgery and before entering cardiac rehabilitation. METHODS: Patients (N = 1323) completed the IB Questionnaire and Hospital Anxiety and Depression Scale (HADS) 9 ± 5 (mean ± SD) days after cardiac surgery. The scores were tested for gender differences in score distributions (Mann-Whitney U test) and in prevalence of clinically relevant scores (the Pearson χ² test). Multivariate regression analyses were made with IB Questionnaire and HADS scores as independent variables, and gender, age, education, marital status, and type of surgery as predictors. RESULTS: Denial was significantly (P < .01) prevalent among the men (3.6 ± 1.4) versus women (3.2 ± 1.6), whereas disease conviction (men = 2.1 ± 1.5, women = 2.5 ± 1.6), dysphoria (men = 1.5 ± 1.5, women = 2.0 ± 1.6), anxiety (men = 6.0 ± 3.6, women = 6.9 ± 3.9), and depression (men = 5.3 ± 3.8, women = 6.5 ± 4.0) were significantly more prevalent among women. The prevalences of clinically relevant scores for disease conviction, anxiety, and depression were also significantly higher in women. Multivariate analysis showed that gender predicted these scores even after the removal of confounders. CONCLUSIONS: Gender differences exist in denial, disease conviction, and dysphoria, probably depending on the culturally assigned roles of men and women. As these aspects of IB may compromise treatment compliance and the quality of life, the efficacy of cardiac rehabilitation programs might be improved taking into account the different prevalences in men and women.

Evaluation of a textile-based wearable system for the electrocardiogram monitoring in cardiac patients.

AIMS: We developed a textile-based wearable system, named MagIC, for the unobtrusive monitoring of one electrocardiogram (ECG) lead, respiratory frequency and motion. In the present study, we investigated the ability of this system to monitor cardiac rhythm and arrhythmic events in cardiac patients. METHODS AND RESULTS: The study was carried out by comparing ECG tracings simultaneously recorded by MagIC and traditional ECG devices (Trad-ECG) in 40 cardiac patients at rest and during physical exercise. Data were manually scored by two cardiologists. At rest the artefact rates observed with MagIC and Trad-ECG were virtually identical (1.4% of the registered signal); while during physical exercise the artefact rate observed with MagIC was much lower than with Trad-ECG (4.07 vs. 17.31%). Recordings from MagIC allowed a correct identification of the type of rhythm in the vast majority of patients (92.5%) and an estimation of PQ interval and QRS duration similar to Trad-ECG (<0.016 s). MagIC displayed a good performance in detecting arrhythmias, with only 14 misclassified events out of 3618, and both specificity and sensitivity being above 99%. No practical difference was observed in the estimation of the beat-by-beat RR interval by the two methods. CONCLUSION: This study indicates that in static condition MagIC has a capability of monitoring cardiac rhythm and arrhythmic events which is comparable with what obtainable by a traditional one-lead ECG recorder. During movement MagIC provides an ECG signal of better quality.

Valvulopathies in sub-Saharan African children: patterns, humanitarian interventions and cardiac surgical problems.

Despite the high burden of rheumatic fever in sub-Saharan African, there is currently no sustained and comprehensive strategy to control the disease. Consequently in this area the number of patients affected by rheumatic valve disease (RVD), most with a surgical indication, is 10-20 fold higher than in industrialised countries and estimates indicate that more than 50% of African RVD patients will die before age 25. In this paper, we review clinical and management issues of RVD in children in sub-Saharan Africa. Severe heart failure and undergrowth are the prevalent presentation of the illness. Severe mitral regurgitation is the commonest rheumatic valvulopathy observed in the first and second decades. Valve repair, the approach of choice, may be associated with unfavourable outcomes in patients with extreme cardiomegaly. In young people, whenever correct anticoagulation may reasonably be achieved, mechanical mitral prostheses should be preferred, even in females. The early deterioration of biologic mitral prostheses strongly suggests limiting their use to those cases in which correct anticoagulation is not feasible. In most sub-Saharan countries, socioeconomic factors strongly limit access to health services and to cardiac surgery in particular. Efforts to overcome these barriers have resulted in humanitarian projects along two patterns: creation of high tech on site health care structures or transfer of children with complex diseases to receive highly specialised cardiac surgical care abroad. We summarise the experience of our programme that followed the latter approach.

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.

Pentraxin-3 predicts functional recovery and 1-year major adverse cardiovascular events after rehabilitation of cardiac surgery patients.

BACKGROUND: Inflammatory and vascular markers have proved to be predictors of outcome in myocardial infarction and heart failure. We evaluated several circulating markers of cardiac stress, inflammation, and endothelial function to investigate their ability to predict short-term functional recovery and long-term clinical outcome in heart surgery patients undergoing inpatient rehabilitation. METHODS: This prospective, multicenter study enrolled 223 patients after heart surgery, included in a 3-week program of standardized and supervised physical training. The association between biomarkers (pentraxin-3 [PTX3], brain natriuretic peptide, high-sensitivity cardiac troponin-T [hs-cTnT] and C-reactive protein [hsCRP], creatine kinase, myoglobin, and urinary albumin excretion [UACR]) and exercise capacity (6-minute walk test, 6MWT) or 1-year incidence of major adverse cardiovascular events (MACE) was tested in models that included biohumoral markers, and clinical and instrumental variables. RESULTS: The patients (69.5% men, mean age of 67 ± 11 years) were enrolled after valvular surgery (52.7%) and 58.6% after coronary artery bypass grafting (CABG). Exercise capacity improved during rehabilitation (6MWT distance from 279 ± 95 to 386 ± 91 m; P < .0001); concentrations of most biomarkers decreased (hsCRP: 79% [P < .0001]; hs-cTnT: 57% [P < .0001]; UACR: 36% [P = .05]). Among the tested markers, PTX3 showed the closest association with 6MWT distance (P = .01) and was the only predictor of MACE, also in the subgroup of CABG patients (OR [95% CI] = 1.14 [1.03-1.27]; P = .015). CONCLUSION: PTX3, a marker of vascular inflammation and cardiovascular damage, is a predictor of short-term functional recovery and 1-year MACE in patients undergoing rehabilitation after cardiac surgery, regardless of clinical and instrumental parameters.

Functioning and disability in ischaemic heart disease.

OBJECTIVE: To describe functioning and disability in patients with stable ischaemic heart disease (IHD) according to the model endorsed by the International Classification of Functioning Disability and Health (ICF). DESIGN: Adult patients with IHD undergoing rehabilitation were consecutively enrolled. The ICF checklist and the WHO Disability Assessment Schedule II (WHO-DAS II) were administered in individual sessions. Patients' clinical status was described following NYAH criteria (New York Heart Association). Descriptive analyses were performed to report on clinical variables and WHO-DAS II scores. ICF categories reported as a problem by more than 20% of patients were described in detail. RESULTS: One hundred patients (mean age 62.9; 91% males, 71% in NYHA class II) were enrolled. Mean WHO-DAS II score was 23.9, and the most severe limitations are reported in life activities, getting around and in participation to social situations. A total of 30 ICF categories reached the threshold of 20%, 17 Body Functions and Structures, 13 Activities and Participation. CONCLUSIONS: ICF application in patients with IHD enables to enlarge the perspective on their health status, and provide useful information to follow the healthcare process from the acute setting to the outpatient management.