Effects of a brief intervention based on Acceptance and Commitment Therapy versus usual care for cardiac rehabilitation patients with coronary heart disease (ACTonHEART): a randomised controlled trial.

OBJECTIVES: The main objective of the study is to investigate the short-term efficacy of Acceptance and Commitment Therapy (ACT) on the simultaneous modification of biological indicators of risk and psychological well-being in patients with coronary heart disease attending cardiac rehabilitation (CR). DESIGN: This was a two-arm randomised controlled trial comparing a brief, manualised, ACT-based intervention with usual care (UC). SETTING: The study was conducted in an outpatient CR unit in Italy. Data collection took place from January 2016 to July 2017. PARTICIPANTS: Ninety-two patients were enrolled and randomised, following an unbalanced randomisation ratio of 2:1 to the ACT group (n=59) and the control group (n=33). Eighty-five patients completed the ACT (n=54) and the UC (n=31) interventions and were analysed. INTERVENTIONS: The control group received UC, a 6 weeks multidisciplinary outpatient CR programme, encompassing exercise training, educational counselling and medical examinations. The experimental group, in addition to UC, participated in the Acceptance and Commitment Therapy on HEART disease (ACTonHEART) intervention encompassing three group sessions based on ACT. OUTCOMES: The primary outcomes were Low Density Lipoproteins (LDL)cholesterol, resting systolic blood pressure, body mass index (BMI) and psychological well-being measured by the Psychological General Well-Being Index (PGWBI). Outcome measures were assessed at baseline and at the end of CR. RESULTS: Based on linear mixed models, no significant group × time interaction was observed for either the primary outcomes (ß, 95% CI: PGWBI =-1.13, -6.40 to -4.14; LDL cholesterol =-2.13, -11.02 to -6.76; systolic blood pressure =-0.50, -10.76 to -9.76; diastolic blood pressure =-2.73, -10.12 to -4.65; BMI =-0.16, -1.83 to -1.51, all p values >0.05) or the secondary outcomes (all p values >0.05). A significant time effect was found for the PGWBI total (beta=4.72; p=0.03). CONCLUSIONS: Although analyses revealed null findings, the results can inform the design of future ACT-based CR interventions and can help researchers to strike a balance between the idealised implementation of an ACT intervention and the structural limitations of existing CR programmes. TRIAL REGISTRATION NUMBER: NCT01909102.

Effects of cardiac rehabilitation on cardiopulmonary test parameters in heart failure: A real world experience.

Background: Cardio-Pulmonary Exercise Test (CPET) is the gold standard for evaluation of patients with heart failure (HF); however, its use is limited in everyday practice. We analyzed the use of CPET for HF management in the real world. Methods: From 2009 to 2022, 341 patients with HF underwent 12-16 weeks of rehabilitation in our Centre. We present data from 203 patients (60%), excluding those unable to perform CPET, those with anaemia and severe pulmonary disease. Before and after rehabilitation, we performed CPET, blood tests and echocardiography, tailoring individual physical training to the results of baseline test. The following variables were considered: peak Respiratory Equivalent Ratio (RER), peakVO2 (ml/Kg/min), VO2 at aerobic threshold (VO2AT,% maximal), VE/VCO2 slope, P(ET)CO2, VO2 /Work ratio (ΔVO2/ΔWork). Results: Rehabilitation improved peak VO2, pulse O2, VO2 AT and ΔVO2/ΔWork in all patients by about 13% (p < 0.01). Most patients (126, 62%) showed a reduced left ventricular ejection fraction (HFrEF), but rehabilitation was effective also in patients with mildly reduced (HFmrEF: n = 55, 27%) or preserved ejection fraction (HFpEF: n = 22, 11%). Conclusions: Rehabilitation in patients with heart failure induces a significant recovery of cardiorespiratory performance easily assessed by CPET, that is applicable to the majority of them and should be used routinely in the programming and evaluating of cardiac rehabilitation programs.

Lung Ultrasound in Patients With SARS-COV-2 Pneumonia: Correlations With Chest Computed Tomography, Respiratory Impairment, and Inflammatory Cascade.

OBJECTIVES: Lung ultrasound (LUS) might be comparable to chest computed tomography (CT) in detecting parenchymal and pleural pathology, and in monitoring interstitial lung disease. We aimed to describe LUS characteristics of patients during the hospitalization for COVID-19 pneumonia, and to compare the extent of lung involvement at LUS and chest-CT with inflammatory response and the severity of respiration impairment. METHODS: During a 2-week period, we performed LUS and chest CT in hospitalized patients affected by COVID-19 pneumonia. Dosages of high sensitivity C-reactive protein (HS-CRP), d-dimer, and interleukin-6 (IL-6) were also obtained. The index of lung function (P/F ratio) was calculated from the blood gas test. LUS and CT scoring were assessed using previously validated scores. RESULTS: Twenty-six consecutive patients (3 women) underwent LUS 34 ± 14 days from the early symptoms. Among them, 21 underwent CT on the same day of LUS. A fair association was found between LUS and CT scores (R = 0.45, P = .049), which became stronger if the B-lines score on LUS was not considered (R = 0.57, P = .024). LUS B-lines score correlated with IL-6 levels (R = 0.75, P = .011), and the number of involved lung segments detected by LUS correlated with the P/F ratio (R = 0.60, P = .019) but not with HS-CRP and d-Dimer levels. No correlations were found between CT scores and inflammations markers or P/F. CONCLUSION: In patients with COVID-19 pneumonia, LUS was correlated with both the extent of the inflammatory response and the P/F ratio.

Cardiac-specific experiential avoidance predicts change in general psychological well-being among patients completing cardiac rehabilitation.

Previous studies have shown that experiential avoidance (EA) is associated with physical and psychological well-being in medical and non-medical samples. The aims of the present study were to evaluate the reciprocal association between psychological well-being and EA over time among cardiac rehabilitation (CR) patients with moderately to severely low levels of psychological well-being. Pre-CR data on demographic characteristics, measures of psychological well-being, and cardiac-specific EA were collected from 915 CR patients, as well as post-CR psychological well-being and EA data, from 800 of these patients. A cross-lagged model was estimated to examine the relationship between EA and psychological well-being among patients with moderately to severely low levels of psychological well-being based on questionnaire scores. Both EA and psychological well-being significantly changed during CR and were negatively associated with each other at both pre- and post-CR. Results from cross-lagged structural equation modeling supported a nonreciprocal association between EA and psychological well-being during CR. Pre-CR assessment of EA in patients showing low levels of well-being at the beginning of CR could help to identify patients at risk for worse psychological outcomes. EA could be a promising target of psychological treatments administered during CR.

[Safety and efficacy of early discharge and outpatient rehabilitation after myocardial infarction for low-risk patients]. / Sicurezza ed efficacia della dimissione precoce associata a riabilitazione ambulatoriale dopo infarto miocardico nel paziente a basso rischio.

BACKGROUND: Guidelines recommend early discharge and rehabilitation after ST-elevation myocardial infarction (STEMI) in low-risk patients. However, low risk is not established according to well-defined criteria and often it depends on subjective judgment. The aim of this real-life study is to confirm that early discharge is safe in patients at low risk according to selected criteria and subsequent outpatient rehabilitation is associated with clinical benefits. METHODS: Patients with STEMI treated with primary percutaneous coronary intervention from October 2010 to October 2017, identified as being at low risk (according to predefined criteria), discharged by day 5, were studied retrospectively. Basal characteristics and 30-day outcome were evaluated and a comparison was made between patients who completed or did not complete outpatient rehabilitation. RESULTS: We enrolled 193 STEMI patients treated with percutaneous coronary intervention for STEMI, early discharged and at low risk: 132 completed outpatient rehabilitation and 61 did not. The increase in cardiac enzymes and the occurrence of arrhythmias were the only independent predictors of completion of outpatient rehabilitation. After 30 days from discharge, adverse events were rare and not significantly different between groups. Optimal pharmacological therapy was achieved more often in the rehabilitation group (58.3% vs 44.3%; p<0.05). CONCLUSIONS: Early discharge within 5 days of STEMI has been proved feasible and safe in our population of well-defined low-risk patients. Early participation in a rehabilitation program was associated with a more adequate titration of therapy.

Cardiac autonomic regulation in patients undergoing pulmonary vein isolation for atrial fibrillation.

AIMS: Ablation procedures for the treatment of atrial fibrillation lead to changes in autonomic heart control; however, there are insufficient data on the possible association of these changes with atrial fibrillation recurrence. The study aim was to assess the effects of pulmonary vein isolation (PVI) on cardiac autonomic modulation and atrial fibrillation recurrence. METHODS: We screened 52 patients with atrial fibrillation referred for PVI, of whom 20 patients met inclusion and exclusion criteria, and were enrolled in the study and followed over 6 months. Beat-to-beat blood pressure monitoring was performed 1-2 days before PVI, 1 and 6 months after PVI. We estimated pulse interval variability and spontaneous baroreflex sensitivity (BRS) both in the time and frequency domains, and performed the Valsalva manoeuvre assessing the Valsalva ratio. RESULTS: During 6 months after PVI, atrial fibrillation recurrence was observed in six patients. One month after PVI, pulse interval variability and BRS (sequence method) significantly decreased in all patients, returning to preintervention values by 6 months. Patients without atrial fibrillation recurrence at 1 month showed a transient reduction in pulse interval variability (frequency domain) and in BRS (both methods) in contrast to those with atrial fibrillation recurrence. A significant decrease in the Valsalva ratio observed at 1 month was maintained at 6 months after PVI in both groups. CONCLUSION: Successful PVI may lead to transient autonomic alterations reflected by a reduction in pulse interval variability and BRS, with more prolonged changes in the Valsalva ratio. The efficacy of PVI in preventing atrial fibrillation recurrence seems to be related to transient parasympathetic atrial denervation.

Cross-Lagged Relations Between Exercise Capacity and Psychological Distress During Cardiac Rehabilitation.

Background: Poorer mental health is associated with lower exercise capacity, above and beyond the effect of other cardiovascular risk factors. However, the directionality of this relationship remains unclear. Purpose: The main aim of the present study was to clarify, with a cross-lagged panel design, the relationship between psychological status and exercise capacity among patients in a cardiac rehabilitation (CR) program. Methods: A clinical sample of 212 CR patients completed exercise-capacity testing and measures of depression and anxiety (Hospital Anxiety and Depression Scale) pre-CR and post-CR. Demographic and clinical data, including BMI and smoking history, were also collected. Multivariate stepwise regression analysis was performed to identify the best predictors of exercise capacity at discharge. Structural equation modeling was utilized to quantify the cross-lagged effect between exercise capacity and psychological distress. Results: Multivariate regression analysis revealed that higher levels of psychological distress pre-CR are predictively associated with less improvement in exercise capacity post-CR, beyond the effects of age, sex, and baseline functional status. Results from structural equation modeling supported a 1-direction association, with psychological distress pre-CR predicting lower exercise capacity post-CR over and above autoregressive effects. Conclusions: Study results did not support the hypothesis of a bidirectional relationship between psychological distress and EC. High levels of psychological distress pre-CR appeared to be longitudinally associated with lower exercise capacity post-CR, but not vice versa. This finding highlights the importance of assessing and treating both anxiety and depression in the early phase of secondary prevention programs.

A brief period of intensive cardiac rehabilitation improves global longitudinal strain and diastolic function after a first uncomplicated myocardial infarction.

Objectives In patients with abnormal left ventricular ejection fraction (LVEF) after acute myocardial infarction (AMI), cardiac rehabilitation with physical training prevents cardiac remodelling. To define the role of rehabilitation in the recovery of ventricular function in less severe cases, we studied its effects on more refined indexes of left ventricular function in uncomplicated, low-risk patients. Methods and results Fifty-five patients underwent percutaneous coronary revascularization after uncomplicated first AMI. Thirty-four started cardiac rehabilitation with counselling and physical training; 21 patients did not train, followed a counselling program and were taken as controls. Echocardiography was performed at baseline, after rehabilitation or counselling program and at six months follow-up. We measured: global strain (GS%) with speckle tracking analysis, E/e' by tissue Doppler imaging (TDI), left ventricular elastance (KLV) from the deceleration time (DT), LVEF, systolic and diastolic volumes, wall motion score index (WMSI). At baseline, groups had similar GS%, KLV, LVEF, DT, E/e', systolic and diastolic volumes, WMSI. Rehabilitation increased peak VO2 by 18% (P < 0.05) and improved GS%, KLV, LVEF, E/e' and WMSI (P < 0.02) that were unchanged in controls. The improvement persisted at six months. Conclusions After a first uncomplicated AMI, abnormalities of left systolic and diastolic ventricular function may be present persisting over time despite a normal LVEF, which are fully reverted by cardiac rehabilitation.

Intermittent levosimendan infusions in advanced heart failure: a real world experience.

Objective To analyse the effects of levosimendan infusions in advanced heart failure. Methods Patients with advanced heart failure treated with repeated levosimendan infusions were retrospectively compared with controls. Clinical, blood and echocardiographic parameters were obtained at baseline and after 12 months, and before and after each levosimendan infusion. Hospitalizations for heart failure and in-hospital length of stay in the 6 months before enrolment and after 6 and 12 months were recorded, along with 1-year mortality. Results Twenty-five patients treated with levosimendan and 25 controls were studied. After each levosimendan infusion, ventricular function and various clinical and metabolic parameters were improved. After 12 months, left ventricular ejection fraction (LVEF) had improved compared with baseline in the levosimendan group. The 1-year mortality rate was similar in both groups. During the 6 months before enrolment, hospitalizations were fewer in controls compared with the levosimendan group; after 6 and 12 months they increased in controls and decreased in the levosimendan group. Seven patients were super-responders to levosimendan, with LVEF improving more than 20% and hospitalizations being reduced at 12 months compared with the rest of the levosimendan group. Conclusion Intermittent levosimendan improved LVEF and decreased hospitalizations in advanced heart failure and represents a therapeutic option for patients whose disease is worsening.

Retrospective application of Program to Access and Review Trending iNformation and Evaluate coRrelation to Symptoms in patients with Heart Failure criteria for the remote management of patients with cardiac resynchronisation therapy.

Aim The Program to Access and Review Trending iNformation and Evaluate coRrelation to Symptoms in patients with Heart Failure (PARTNERS HF) trial elaborated a multiparametric model for prediction of acute decompensation in advanced heart failure patients, based on periodical in office data download from cardiac resynchronisation devices. In this study, we evaluated the ability of the PARTNERS HF criteria to detect initial decompensation in a population of moderate heart failure patients under remote monitoring. Methods We retrospectively applied the PARTNERS HF criteria to 1860 transmissions from 104 patients (median follow up 21 months; range 1-67 months), who were enrolled in our programme of telemedicine after cardiac resynchronisation therapy. We tested the ability of a score based on these criteria to predict any acute clinical decompensation occurring in the 15 days following a transmission. Results In 441 cases, acute heart failure was diagnosed after the index transmission. The area under the curve (AUC) of the score for the diagnosis of acute decompensation was 0.752 (confidence interval (CI) 95% 0.728-0.777). The best score cut-off was consistent with the results of PARTNERS HF: with a score ≥2, sensitivity was 75% and specificity 68%. The odds ratio for events was 6.24 (CI 95% 4.90-7.95; p < 0.001). Conclusions When retrospectively applied to remote monitoring transmissions and arranged in a score, PARTNERS HF criteria could identify HF patients who subsequently developed acute decompensation. These results warrant prospective studies applying PARTNERS HF criteria to remote monitoring.

Current activities of Cardiovascular Rehabilitation in the ambulatory setting of the Lombardy Region.

In the present work, the current activities of Cardiovascular Rehabilitation and Prevention (CRP) in the ambulatory setting of the Lombardy Region (Italy) are described. Based on the 2012 Legislation, ambulatory CRP is delivered by means of three programme categories (MAC 6, 7, and 8) with different degrees of intensity. The patient evaluation of global cardiovascular/clinical risk, comorbidity, and disability is the cornerstone for MAC prescription. Following the organization of MAC activities, a survey on 327 patients was carried out by the regional network of the Italian Society of Cardiovascular Rehabilitation (GICR-IACPR). Globally, acute coronary syndromes (with or without coronary revascularization) constituted the main access group to CRP. More than 60% of patients displayed a condition of high risk, comorbidity, and disability. The outcome of ambulatory CRP by means of MAC 6 and 7 was satisfactory, while in the 'less intensive' MAC 8 patients with complete drug up-titration and achievement of secondary prevention targets were no more than 70%.

Lung ultrasound and transthoracic impedance for noninvasive evaluation of pulmonary congestion in heart failure.

BACKGROUND: In patients with heart failure, many indexes are available for noninvasive identification of pulmonary congestion: E/E' at echocardiography; plasma levels of brain natriuretic peptide (BNP) (pg/ml); number of B-lines at lung ultrasound; and transthoracic conductance [thoracic fluid content (TFC)TT = 1/Ω] at impedance cardiography (ICG). METHODS: We obtained 75 measures from 50 patients (72 ±â€Š10 years, NYHA 2.4 ±â€Š0.7, ejection fraction 31 ±â€Š7%), 25 of them studied before and after intravenous diuretics, in whom we assessed the following: E/e' from Doppler echocardiogram; BNP plasma levels; presence and number of B-lines at lung ultrasound; and TFCTT from ICG. We determined the relationship among these indexes and their change with treatment, and compared B-lines and TFC for the diagnosis of pulmonary congestion. Finally, we considered the timing and the personnel required for performing and interpreting each test. RESULTS: A mutual relationship was observed between all the variables. After clinical improvement, changes in each variable were of similar direction and magnitude. Congestion (estimated by chest radiograph) was present in 59% of the patients: TFC value and B-line number had the best sensitivity and specificity for its detection. BNP determination and ICG assessment were performed by a nurse (15 min), and echocardiography and lung ultrasound were performed by a cardiologist (15 min). CONCLUSION: The correlation between all indexes and their consensual change after improvement of the clinical status suggests that they all detect pulmonary congestion, and that using at least two indexes improves sensitivity and specificity. The choice among the methods may be determined by the patient characteristics or by the clinical setting.

Correlation between trans and intra-thoracic impedance and conductance in patients with chronic heart failure.

AIMS: In chronic heart failure, changes of intra-thoracic impedance (Z0IT) may suggest impending pulmonary congestion; a similar result has been found by measuring trans-thoracic conductance (TFCTT = 1/Z0 = 1/kΩ). We assumed that a relationship could exist between Z0IT and TFCTT. METHODS: We collected 140 measurements from 70 patients carrying an implantable cardioverter-defibrillator/cardiac resynchronization device with the CareLink function (71 ± 9 years, New York Heart Association (NYHA) 2.4 ± 0.9, ejection fraction 31 ± 8%, optimal treatment); they were studied during system alarms and after appropriate treatment (diuretics and/or vasodilators, n = 42) or during clinical stability and at the time of a system alarm (n = 28); correspondent BNP values were obtained. We related Z0IT obtained by the device, with TFCTT obtained with a commercial system. RESULTS: A strong relationship was found between Z0IT and TFCTT. Changes in the variables after treatment or during worsening conditions were of the same direction and order of magnitude, and were related to BNP levels obtained simultaneously. CONCLUSIONS: Trans-thoracic conductance, similarly to intra-thoracic impedance, may noninvasively point to pulmonary congestion and be useful in patients not carrying an implanted device. The possibility of remotely obtaining this variable should be evaluated for the telemonitoring of heart failure patients.

Pulmonary congestion at rest and abnormal ventilation during exercise in chronic systolic heart failure.

BACKGROUND: In patients with chronic heart failure, abnormal ventilation at cardiopulmonary testing (expressed by minute ventilation-to-carbon dioxide production, or VE/VCO2 slope, and resting end-tidal CO2 pressure) may derive either from abnormal autonomic or chemoreflex regulation or from lung dysfunction induced by pulmonary congestion. The latter hypothesis is supported by measurement of pulmonary capillary wedge pressure, which cannot be obtained routinely but may be estimated noninvasively by measuring transthoracic conductance (thoracic fluid content 1/kΩ) with impedance cardiography. METHODS AND RESULTS: Preliminarily, in 9 patients undergoing invasive hemodynamics during cardiopulmonary testing, we demonstrated a significant relationship between VE/VCO2 slope and resting end-tidal CO2 pressure with baseline and peak pulmonary capillary wedge pressure. Later, noninvasive hemodynamic evaluation by impedance cardiography was performed before cardiopulmonary testing in 190 patients with chronic systolic heart failure and normal lung function (aged 67±3 years, 71% with ischemia, ejection fraction 32±7%, 69% with implantable cardioverter-defibrillator or cardiac resynchronization therapy). In this group, we determined the relationship between abnormal ventilation (VE/VCO2 slope and resting end-tidal CO2 pressure) and transthoracic conductance. In the whole population, thoracic fluid content values were significantly related to VE/VCO2 slope (R=0.63, P<0.0001) and to resting end-tidal CO2 pressure (R=-0.44, P<0.001). CONCLUSIONS: In patients with chronic heart failure, abnormal ventilation during exercise may be related in part to pulmonary congestion, as detected by resting baseline impedance cardiography.

Development and initial validation of the Cardiovascular Disease Acceptance and Action Questionnaire (CVD-AAQ) in an Italian sample of cardiac patients.

Psychological inflexibility refers to the attempt to decrease internal distress even when doing so is inconsistent with life values, and has been identified as a potential barrier to making and maintaining health behavior changes that are consistent with a heart-healthy lifestyle. Disease- and behavior-specific measures of psychological inflexibility have been developed and utilized in treatment research. However, no specific measure has been created for patients with heart disease. Thus, the CardioVascular Disease Acceptance and Action Questionnaire (CVD-AAQ) was developed. The present study is aimed to evaluate the psychometric properties of the CVD-AAQ and to explore its association with measures of psychological adjustment and cardiovascular risk factors in an Italian sample of 275 cardiac patients. Exploratory factor analysis showed a structural one-factor solution with satisfactory internal consistency and test-retest reliability. The relation with other measures was in the expected direction with stronger correlations for the theoretically consistent variables, supporting convergent and divergent validity. CVD-AAQ scores were associated with general psychological inflexibility, anxiety and depression and inversely correlated with psychological well-being. Moreover, the results showed that CVD-AAQ scores are associated with two relevant risk factors for cardiac patients, namely low adherence to medication and being overweight. In sum, results suggest that the CVD-AAQ is a reliable and valid measure of heart disease-specific psychological inflexibility with interesting clinical applications for secondary prevention care.

Prognostic value of noninvasive hemodynamic evaluation of the acute effect of levosimendan in advanced heart failure.

AIMS: Optimization of inotropic treatment in worsening heart failure sometimes requires invasive hemodynamic assessment in selected patients. Impedance cardiography (ICG) may be useful for a noninvasive hemodynamic evaluation. METHODS: ICG was performed in 40 patients (69 ± 8 years; left ventricular ejection fraction 27.5 ± 5.6%; New York Heart Association 3.18 ± 0.34; Interagency Registry for Mechanically Assisted Circulatory Support 5.48 ± 0.96, before and after infusion of Levosimendan (0.1­0.2 µg/kg per min for up to 24 h). Echocardiogram, ICG [measuring cardiac index (CI), total peripheral resistances (TPRs) and thoracic fluid content (TFC)] and plasma levels of brain natriuretic peptide (BNP) were obtained; in nine patients, right heart catheterization was also carried out. RESULTS: When right catheterization and ICG were performed simultaneously, a significant relationship was observed between values of CI and TPR, and between TFC and pulmonary wedge pressure. ICG detected the Levosimendan-induced recovery of the hemodynamic status, associated with improved systolic and diastolic function and reduction in BNP levels. One-year mortality was 4.4%. At multivariate analysis, independent predictors of mortality were: no improvement in the severity of mitral regurgitation, a persistent restrictive filling pattern (E/E' > 15), a reduction of BNP levels below 30% and a change below 10% in CI, TPR and TFC. When combined, absence of hemodynamic improvement at ICG could predict 1-year mortality with better sensitivity (86%) and specificity (85%) than the combination of echocardiographic and BNP criteria only (sensitivity 80% and specificity 36%). CONCLUSION: Noninvasive hemodynamic evaluation of heart failure patients during infusion of inodilator drugs is reliable and may help in their prognostic stratification.

The ACTonHEART study: rationale and design of a randomized controlled clinical trial comparing a brief intervention based on Acceptance and Commitment Therapy to usual secondary prevention care of coronary heart disease.

BACKGROUND: Modifiable risk factors, including life-style habits and psychological variables, have been increasingly demonstrated to have an important role in influencing morbidity and mortality in cardiovascular patients, and to account for approximately 90% of the population risk for cardiac events.Acceptance and Commitment Therapy (ACT) has shown effectiveness in promoting healthy behaviors, and improving psychological well-being in patients with chronic physical conditions. Moreover, a first application of an acceptance-based program in cardiac patients has revealed high treatment satisfaction and initial evidences of effectiveness in increasing heart-healthy behaviour. However, no clinical trial to date has evaluated the efficacy of an acceptance-based program for the modification of cardiovascular risk factors and the improvement of psychological well-being, compared to usual secondary prevention care. METHODS: Approximately 168 patients will be recruited from an outpatient cardiac rehabilitation unit and randomly assigned to receive usual care or usual care + a brief ACT-based intervention. The ACT group will be administered five group therapy sessions integrating educational topics on heart-healthy behaviours with acceptance and mindfulness skills. Participants will be assessed at baseline, six weeks later (post treatment for the ACT condition), at six and twelve months follow-up.A partially-nested design will be used to balance effects due to clustering of participants into small therapy groups. Primary outcome measures will include biological indicators of cardiovascular risk and self-reported psychological well-being. Treatment effects will be tested via multilevel modeling after which the mediational role of psychological flexibility will be evaluated. DISCUSSION: The ACTonHEART study is the first randomized clinical trial designed to evaluate the efficacy of a brief group-administered, ACT-based program to promote health behavior change and psychological well-being among cardiac patients. Results will address the effectiveness of a brief treatment created to simultaneously impact multiple cardiovascular risk factors. Conducted in the context of clinical practice, this trial will potentially offer empirical support to alternative interventions to improve quality of life and reduce mortality and morbidity rates among cardiac patients. TRIAL REGISTRATION: clinicaltrials.gov/ (NCT01909102).

Transthoracic bioimpedance and brain natriuretic peptide assessment for prognostic stratification of outpatients with chronic systolic heart failure.

BACKGROUND: In patients with chronic heart failure, physical evaluation and clinical judgment may be inadequate for prognostic stratification. HYPOTHESIS: Information obtained with simple bedside tests would be helpful in patient management. METHODS: We report on 142 outpatients with systolic heart failure seen at our heart failure unit from 2007 to 2010 (ages 69.4 ± 8.9 years; ejection fraction [EF] 30.6 ± 6.1%; 43% with implanted defibrillators and/or resynchronization devices). At their first visit, we assessed levels of brain natriuretic peptide (BNP) (pg/mL), evaluated transthoracic conductance (TFC) (1/kΩ) by transthoracic bioimpedance, and performed echocardiography. RESULTS: Four-year mortality was 21.2%. At multivariate analysis, surviving and deceased subjects did not differ regarding New York Heart Association, age, gender, heart failure etiology, or EF at index visit. Patients who died had higher BNP and TFC (BNP = 884 ± 119 pg/mL vs 334 ± 110 pg/mL; TFC = 50 ± 8/kΩ vs 37 ± 7/kΩ, both P < 0.001]. Patients with BNP < 450 pg/mL and TFC < 40/kΩ had a 2.1% 4-year mortality, compared to 46.5% mortality of patients having BNP ≥ 450 pg/mL and TFC ≥ 40/kΩ. BNP ≥ 450 pg/mL and TFC ≥ 40/kΩ showed high sensitivity (91%) and specificity (88%)in identifying patients who died at follow-up. CONCLUSIONS: The combined use of BNP and impedance cardiography during the first assessment of a patient in a heart failure unit identified those carrying a worse medium-term prognosis. This approach could help the subsequent management of patients, allowing better clinical and therapeutic strategies.

Intermittent levosimendan infusions in advanced heart failure: favourable effects on left ventricular function, neurohormonal balance, and one-year survival.

The role of repeated infusions of Levosimendan (LEVO) in patients with chronic advanced heart failure is still unclear. Thirty-three patients with chronic heart failure presenting clinical deterioration were randomized 2:1 to receive monthly infusions of LEVO (n = 22) or Furosemide (Controls, n = 11). At the first drug's administration, noninvasive hemodynamic evaluation was performed; before and after each infusion, we assessed NYHA class, systolic and diastolic function, functional mitral regurgitation, and brain natriuretic peptide (BNP) levels. Noninvasive hemodynamic in the LEVO group showed vasodilation and decrease in thoracic conductance (index of pulmonary congestion), whereas in Controls, only a reduced thoracic conductance was observed. In the LEVO group, systolic and diastolic function, ventricular volumes, severity of mitral regurgitation, and BNP levels improved over time from baseline and persisted 4 weeks after the last infusion (P < 0.01). In Controls, no change developed over time in cardiac function and BNP levels. In LEVO-treated patients, 1-year mortality tended to be lower than in those treated with Furosemide. In conclusion, serial LEVO infusions in advanced heart failure improved ventricular performance and favorably modulated neurohormonal activation. Multicenter randomized studies are warranted to test the effect of LEVO on long-term outcome.

Transthoracic impedance accurately estimates pulmonary wedge pressure in patients with decompensated chronic heart failure.

Routine cardiac catheterization to assess pulmonary capillary wedge pressure (PCWP) is not recommended in heart failure (HF), and various noninvasive tools have been proposed. The authors evaluated the reliability of echocardiography, brain natriuretic peptide (BNP), and thoracic electrical bioimpedance (TEB) in predicting PCWP in 29 patients (72±4 years, New York Heart Association class 3.5±0.9, ejection fraction 28%±6%) who underwent hemodynamic evaluation for worsening HF. Echocardiography was performed immediately before the hemodynamic study. During clinical stability, PCWP, plasma BNP, and TEB were simultaneously assessed. Among TEB variables, thoracic conductance (thoracic fluid content [TFC]=1/kΩ) was used. PCWP was related with E/E' obtained with mitral Doppler and mitral annulus tissue Doppler imaging echocardiography ( R=0.55, P<.005), with BNP levels (R=0.43, P<.01) and TFC values (R=0.69, P<.001). For detection of PCWP ≥15 mm Hg, TFC ≥35/kΩ had high specificity (97%) and sensitivity (86%) and negative (92%) and positive (97%) predictive value, while E/E' and BNP levels had poorer specificity. After infusion of the inodilator levosimendan, changes in TFC and PCWP were of the same order of magnitude and mutually related. In worsening HF, TEB could help avoid right heart catheterization, since it may estimate PCWP better than BNP or echocardiography. Moreover, TFC could be used for noninvasive assessment of drugs' effect.