Effect of remote monitoring on clinical outcomes in European heart failure patients with an implantable cardioverter-defibrillator: secondary results of the REMOTE-CIED randomized trial.

AIMS: Remote patient monitoring (RPM) systems offer a promising alternative to conventional In-Clinic check-ups, hereby reducing unnecessary clinic visits. Especially with the rise of the COVID-19 pandemic, this reduction is of paramount importance. Regarding the association between RPM and clinical outcomes, findings of previous studies have been inconsistent. The aim of this study is to elucidate the effect of partly substituting In-Clinic visits by RPM on clinical outcomes in implantable cardioverter-defibrillator (ICD) patients. METHODS AND RESULTS: The study included 595 heart failure patients (LVEF ≤35%; NYHA Class II/III) implanted with an ICD compatible with the Boston Scientific LATITUDE™ system. Participants were randomized to RPM plus an annual In-Clinic visit or 3-6 months In-Clinic check-ups alone. The investigated endpoints after 2 years of follow-up included a composite of all-cause mortality and cardiac hospitalization, mortality and cardiac hospitalization as independent endpoints and ICD therapy. The incidence of mortality and hospitalization did not differ significantly as independent, nor as composite endpoint between the RPM and In-Clinic group (all Ps <0.05). The results were similar regarding ICD therapy, except for appropriate ICD therapy (odds ratio 0.50; 95% confidence interval 0.26-0.98; P = 0.04). Exploratory subgroup analyses indicated that the effect of RPM differs between patients with specific characteristics, i.e. ≥60 years and permanent atrial fibrillation (all Ps < 0.05). CONCLUSION: RPM is non-inferior to conventional In-Clinic visits regarding clinical outcomes. Routine In-Clinic follow-up may partly be substituted by RPM without jeopardizing safety and efficiency, and thus reducing unnecessary In-Clinic visits. CLINICALTRIALS.GOV IDENTIFIER: NCT01691586.

Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial.

AIMS: The European REMOTE-CIED study is the first randomized trial primarily designed to evaluate the effect of remote patient monitoring (RPM) on patient-reported outcomes in the first 2 years after implantation of an implantable cardioverter-defibrillator (ICD). METHODS AND RESULTS: The sample consisted of 595 European heart failure patients implanted with an ICD compatible with the Boston Scientific LATITUDE® RPM system. Patients were randomized to RPM plus a yearly in-clinic ICD check-up vs. 3-6-month in-clinic check-ups alone. At five points during the 2-year follow-up, patients completed questionnaires including the Kansas City Cardiomyopathy Questionnaire and Florida Patient Acceptance Survey (FPAS) to assess their heart failure-specific health status and ICD acceptance, respectively. Information on clinical status was obtained from patients' medical records. Linear regression models were used to compare scores between groups over time. Intention-to-treat and per-protocol analyses showed no significant group differences in patients' health status and ICD acceptance (subscale) scores (all Ps > 0.05). Exploratory subgroup analyses indicated a temporary improvement in device acceptance (FPAS total score) at 6-month follow-up for secondary prophylactic in-clinic patients only (P < 0.001). No other significant subgroup differences were observed. CONCLUSION: Large clinical trials have indicated that RPM can safely and effectively replace most in-clinic check-ups of ICD patients. The REMOTE-CIED trial results show that patient-reported health status and ICD acceptance do not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation.ClinicalTrials.gov Identifier: NCT01691586.

Remote monitoring of implantable cardioverter defibrillators: Patient experiences and preferences for follow-up.

BACKGROUND: Patient satisfaction with remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) seems to be high, yet knowledge on long-term patient experiences is limited. The European REMOTE-CIED study explored patients' experiences with RPM, examined patient's preferences for ICD follow-up, and identified determinants of patient's preferences in the first 2 years postimplantation. METHODS: European heart failure patients (N = 300; median age = 66 years [interquartile range (IQR) = 59-73], and 22% female) with a first-time ICD received a Boston Scientific LATITUDE RPM system (Marlborough, MA, USA) and had scheduled in-clinic follow-ups once a year. Patients completed questionnaires at 1-2 weeks and also at 3, 6, 12, and 24 months postimplantation and clinical data were obtained from their medical records. Patient evaluation data were analyzed descriptively, and Student's t-tests/Man-Whitney U tests or Chi-square tests/Fisher's exact tests were performed to examine determinants of patient preferences. RESULTS: At 2 years postimplantation, the median patient satisfaction score with the RPM system was 9 out of 10 (IQR = 8-10), despite 53% of the patients experiencing issues (eg, failure to transmit data). Of the 221 patients who reported their follow-up preferences, 43% preferred RPM and 19% preferred in-clinic follow-up. Patients with a preference for RPM were more likely to be higher educated (P = 0.04), employed (P = 0.04), and equipped with a new LATITUDE model (P = 0.04), but less likely to suffer from chronic obstructive pulmonary disease (P = 0.009). CONCLUSION: In general, patients were highly satisfied with RPM, but a subgroup preferred in-clinic follow-up. Therefore, physicians should include patients' concerns and preferences in the decision-making process, to tailor device follow-up to individual patients' needs and preferences.

Decreased Quality of Life Due to Driving Restrictions After Cardioverter Defibrillator Implantation.

BACKGROUND: Driving restrictions for patients with an implantable cardioverter defibrillator (ICD) may require significant lifestyle adjustment and affect patients' psychological well-being. This study explored the prevalence of, and factors associated with, patient-reported decrease in quality of life due to driving restrictions in the first 2 months postimplantation. METHODS: Dutch ICD patients (N = 334; median age, 64 [interquartile range, 55-70) years; 81% male) completed questionnaires at the time of implantation and 4 months postimplantation, assessing their sociodemographic, psychological, and driving-related characteristics. Clinical baseline data were retrieved from patients' medical records. RESULTS: Nearly half of the patients (49%) reported decreased quality of life due to driving restrictions. Patient-reported reasons included dependency on others/public transport, (social) isolation, and inability to work. Patients reporting decreased quality of life were more likely to be younger (P = .01), to feel that the restriction lasts too long (P = .004), to have considered ICD refusal because of the restrictions (P = .03), and to have Type D personality (P = .02), anxiety (P = .05), depression (P = .003), and ICD-related concerns (P = .02). Multivariable analysis showed that being younger than 60 years (odds ratio [OR], 2.30; 95% confidence interval [CI], 1.09-4.88; P = .03), feeling the driving restriction lasts too long (OR, 1.77; 95% CI, 1.23-2.55; P = .002), and depression (OR, 3.21; 95% CI, 1.09-9.47; P = .035) were independently associated with decreased quality of life due to driving restrictions. CONCLUSIONS: This study indicated that a significant group of ICD patients may experience decreased quality of life because of the driving restrictions postimplantation. The restrictions seem to particularly affect patients who are younger and distressed and patients who feel that the restriction lasts too long.

Impaired Mental Health-Related Quality of Life in Patients with Idiopathic Ventricular Fibrillation.

BACKGROUND: Idiopathic ventricular fibrillation (iVF) is diagnosed in cardiac arrest survivors without an identifiable cause. Data regarding the health-related quality of life (HRQoL) in iVF patients are lacking. The purpose of this study was to investigate the HRQoL of iVF patients and to compare it to patients with an implantable cardioverter defibrillator (ICD) diagnosed with an underlying disease and healthy subjects. METHODS: In 61 iVF patients with an ICD (iVF-ICD) and 59 ICD patients with a diagnosis (diagnosis-ICD), HRQoL was assessed using the 12-item Short-Form Health Survey (SF-12), the EuroQoL-5 dimensions (EQ-5D), the 9-item Patient Health Questionnaire, and the ICD Patient Concerns (ICDC) Questionnaire. In addition, 860 healthy subjects completed the SF-12. RESULTS: IVF-ICD showed similar SF-12 physical summary scores compared with diagnosis-ICD patients (50.8 [interquartile range (IQR) = 42.1-53.9] vs 54.1 [IQR = 46.5-58.3]; P = 0.080) and healthy subjects (51.8 [IQR = 45.9-54.1]; P = 0.691). The mental summary score was impaired in iVF-ICD patients compared with diagnosis-ICD patients (45.9 [IQR = 40.7-49.4] vs 54.6 [IQR = 46.0-57.9]; P < 0.001) and healthy subjects (47.7 [IQR = 43.0-50.4]; P = 0.027). Scores on all five EQ-5D domains were similar between iVF-ICD patients and diagnosis-ICD patients, as well as symptoms of severe depression (19% vs 12%; P = 0.101). ICD concerns were similar between iVF-ICD and diagnosis-ICD patients (ICDC-scores 2 vs 2; P = 0.494). CONCLUSIONS: Data suggest that there is a reduced mental HRQoL in patients with iVF compared to other cardiac arrest survivors. Screening and treatment of psychological distress should therefore be considered in iVF patients.

The patient perspective on remote monitoring of patients with an implantable cardioverter defibrillator: Narrative review and future directions.

BACKGROUND: Studies have shown that remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) is at least comparable to in-clinic follow-up with regard to clinical outcomes and might be cost-effective, yet RPM is not standard clinical practice within Europe. Better insight into the patient perspective on RPM may aid in its acceptance, implementation, and reimbursement. This narrative review (1) summarizes existing evidence on the impact of RPM on patient-reported outcomes and (2) discusses future directions in examining the patient perspective. METHODS AND RESULTS: Literature review indicated that only five randomized trials on RPM in ICD patients included patient-reported outcomes, with inconclusive results. Observational studies show a trend toward good patient satisfaction and acceptation of RPM. Yet, results should be interpreted with caution due to a number of limitations including a potential selection bias, use of generic/nonvalidated questionnaires, relatively short follow-up durations, and a lack of subgroup identification. CONCLUSION: Although RPM seems to be safe, effective, timely, and efficient, the patient perspective has received little attention so far. The scarce evidence on patient-reported outcomes in RPM studies seems to be positive, but future trials with a follow-up of ≥12 months and validated patient-reported outcome measures are needed. The REMOTE-CIED study from our group is the first prospective randomized controlled trial primarily designed to examine the patient perspective on RPM, and is powered to identify characteristics associated with RPM satisfaction and benefit. Results are expected in 2018 and will add valuable information to the current evidence.

Relationship Between Reverse Remodeling and Cardiopulmonary Exercise Capacity in Heart Failure Patients Undergoing Cardiac Resynchronization Therapy.

BACKGROUND: Studies on the relationship between left ventricular reverse remodeling and cardiopulmonary exercise capacity in heart failure patients undergoing cardiac resynchronization therapy (CRT) are scarce and inconclusive. METHODS AND RESULTS: Eighty-four patients with a 1st-time CRT-defibrillator (mean age 65 ± 11; 73% male) underwent echocardiography and cardiopulmonary exercise testing (CPX) before implantation (baseline) and 6 months after implantation. At baseline, patients also completed a set of questionnaires measuring mental and physical health. The association between echocardiographic response (left ventricular end-systolic volume decrease ≥15%) and a comprehensive set of CPX results was examined. Echocardiographic responders (54%) demonstrated higher peak oxygen consumption and better exercise performance than nonresponders at baseline and at 6-month follow-up. Furthermore, only echocardiographic responders showed improvements in ventilatory efficiency during follow-up. Multivariable repeated measures analyses revealed that, besides reverse remodeling, New York Heart Association functional class II and good patient-reported health status before implantation were the most important correlates of higher average oxygen consumption during exercise, and that nonischemic etiology and smaller pre-implantation QRS width were associated with better ventilatory efficiency over time. CONCLUSIONS: During the first 6 months of CRT there was a significant positive association between reverse remodeling and cardiopulmonary exercise capacity.

Distinct trajectories of disease-specific health status in heart failure patients undergoing cardiac resynchronization therapy.

PURPOSE: It is well known that a significant proportion of heart failure patients (10-44 %) do not show improvement in symptoms or functioning from cardiac resynchronization therapy (CRT), yet no study has examined patient-reported health status trajectories after implantation. METHODS: A cohort of 139 patients with a CRT-defibrillator (70 % men; age 65.7 ± 10.1 years) completed the Kansas City Cardiomyopathy Questionnaire (KCCQ) prior to implantation (baseline) and at 2, 6, and 12-14 months post-implantation. Latent class analyses were used to identify trajectories and associates of disease-specific health status over time. RESULTS: All health status trajectories showed an initial small to large improvement from baseline to 2-month follow-up, whereafter most trajectories displayed a stable pattern between short- and long-term follow-up. Low educational level, NYHA class III/IV, smoking, no use of beta-blockers, use of psychotropic medication, anxiety, depression, and type D personality were found to be associated with poorer health status in unadjusted analyses. Interestingly, subgroups of patients (12-20 %) who experienced poor health status at baseline improved to stable good health status levels after implantation. CONCLUSIONS: Levels of disease-specific health status vary considerably across subgroups of CRT-D patients. Classification into poorer disease-specific health status trajectories was particularly associated with patients' psychological profile and NYHA classification. The timely identification of CRT-D patients who present with poor disease-specific health status (i.e., KCCQ score < 50) and a distressed psychological profile (i.e., anxiety, depression, and/or type D personality) is paramount, as they may benefit from cardiac rehabilitation in combination with psychological intervention.

Ventricular tachyarrhythmias and mortality in patients with an implantable cardioverter defibrillator: impact of depression in the MIDAS cohort.

OBJECTIVE: We examined whether depression is independently associated with implantable cardioverter defibrillator (ICD) therapy for ventricular tachyarrhythmias and mortality. METHODS: A cohort of 430 consecutive patients with a first-time ICD (79% men; mean [standard deviation] age = 57.8 [12.1] years) completed the Hospital Anxiety and Depression Scale 1 day before implantation. During follow-up, the ICD was interrogated at 3-month intervals. Cox proportional hazard regression analyses were used to examine the impact of depression on time to first appropriate ICD therapy and all-cause mortality during a median follow-up period of 3.8 years. RESULTS: Of all patients, 108 (25.1%) were depressed. Depression was not associated with time to first appropriate ICD therapy (unadjusted hazard ratio [HR] = 1.07, 95% confidence interval [CI] = 0.73-1.56). However, depression was associated with an increased risk for all-cause mortality (unadjusted HR = 2.18, 95% CI = 1.36-3.49). Depression remained independently associated with all-cause mortality (HR = 1.94, 95% CI = 1.06-3.54, p = .031), after adjusting for demographic and clinical characteristics. Patients who remained depressed during the first 3 months after implantation were at greatest risk for dying (HR = 2.88, 95% CI = 1.29-6.45, p = .010). CONCLUSIONS: The current study showed that depression at the time of implant is not associated with time to first appropriate ICD therapy but almost doubled the risk for all-cause mortality in patients with an ICD. Patients with persistent depression during the first 3 months after implantation face the greatest risk of dying. Current evidence indicates that multifactorial interventions are likely to be the most successful in terms of reducing distress. Whether this translates into enhanced survival has yet to be determined.

Association between brain natriuretic peptide, markers of inflammation and the objective and subjective response to cardiac resynchronization therapy.

INTRODUCTION: Studies suggest that cardiac resynchronization therapy (CRT) can induce a decrease in brain natriuretic peptide (BNP) and systemic inflammation, which may be associated with CRT-response. However, the evidence is inconclusive. We examined levels of BNP and inflammatory markers from pre-CRT implantation to 14months follow-up in CRT-responders and nonresponders, defined by two response criteria. METHODS: We studied 105 heart failure patients implanted with a CRT-defibrillator (68% men; age=65.4±10.1years). The objective CRT-response was defined as a reduction of ⩾15% in left ventricular end systolic volume; subjective CRT-response was defined as an improvement of ⩾10 points in patient-reported health status assessed with the Kansas City Cardiomyopathy Questionnaire. Plasma BNP and markers of inflammation (CRP, IL-6, TNFα, sTNFr1 and sTNFr2) were measured at three time points. RESULTS: Pre-implantation concentrations of TNFα were significantly lower for subjective responders compared to nonresponders (p=.05), but there was no difference in BNP and the other inflammatory markers at baseline. Objective CRT-response was significantly associated with lower BNP levels over time (F=27.31, p<.001), and subjective CRT-response with lower TNFα levels (F=5.67, p=.019). CONCLUSION: Objective and subjective response to CRT was associated with lower levels of BNP and TNFα, respectively, but not with other markers of inflammation. This indicates that response to CRT is not automatically related to a stronger overall decrease in inflammation. Large-scale studies are warranted that further examine the relation between the clinical effects of CRT on inflammatory markers, as the latter have been associated with poor prognosis in heart failure.

Poor health status and distress in cardiac patients: the role of device therapy vs. underlying heart disease.

AIMS: Implantable cardioverter defibrillator (ICD) therapy, which includes the risk of shocks, is considered the primary culprit of reductions in patient reported outcomes (PROs; e.g. health status and distress), thereby negating the role of underlying disease severity. We examined the relative influence of living with an ICD vs. congestive heart failure (CHF) on PROs and compared (i) ICD patients without CHF (ICD only), (ii) CHF patients without an ICD (CHF-only), and (iii) CHF patients with an ICD (ICD + CHF). METHODS AND RESULTS: Separate cohorts of ICD and CHF patients (N = 435; 75% men) completed PROs at baseline, 6 and 12 months. Groups differed on physical health status only at baseline (F((2,415)) = 7.15, P = 0.001) and on anxiety at 12 months (F((2,415)) = 4.04, P = 0.01); ICD + CHF patients had the most impaired physical health status but the lowest anxiety level followed by the ICD only and CHF only patients. Congestive heart failure only patients had the most impaired mental health status and reported the highest level of anxiety as compared to the ICD only (P < 0.001) and ICD + CHF groups (P = 0.009), while the two latter groups did not differ. The effect sizes ranged from very small (0.03) to moderate-large (0.69). Groups did not differ in depression scores. CONCLUSION: Congestive heart failure patients reported worse PROs as compared to ICD patients, although the magnitude of the differences was relatively small. This suggests that the well being of patients is not necessarily negatively influenced by the implantation of an ICD, and that underlying heart disease may have at least an equal if not greater influence on PROs.

Monitoring device acceptance in implantable cardioverter defibrillator patients using the Florida Patient Acceptance Survey.

BACKGROUND: Patient device acceptance might be essential in identifying patients at risk for adverse patient-reported outcomes following implantation of an implantable cardioverter defibrillator (ICD). We examined the validity and reliability of the Florida Patient Acceptance Scale (FPAS) and identified correlates of device acceptance in a Dutch cohort of ICD patients. METHODS: Patients with a first-time ICD (N = 272, mean age = 59.2 ± 11.9, 82% men) recruited from the Erasmus Medical Center, Rotterdam, or the Medisch Spectrum Twente, Enschede, The Netherlands completed the FPAS, the Type D Scale, and the Hospital Anxiety and Depression Scale. RESULTS: Exploratory and confirmatory factor analyses indicated that eliminating three items from the FPAS, leaving 12 items contributing to three factors, is equivalent to the original four-factor version of the FPAS. The abbreviated FPAS had a high internal consistency both for the total scale and all subscales, with Cronbach's alphas ranging from 0.76 to 0.82. Anxiety (odds ratio [OR]: 9.75; 95% confidence interval [CI]: 2.38-39.87; P = 0.002), depression (OR: 2.96; 95% CI: 0.98-8.93; P = 0.05), and the distressed (Type D) personality (OR: 5.04; 95% CI: 1.50-16.92; P = 0.01), but not demographic and clinical factors including shocks, were significant independent correlates of poor device acceptance. CONCLUSION: A shortened 12-item, three-factor version of the FPAS was shown to be a valid and internally consistent instrument to assess device acceptance in Dutch ICD patients. Psychological but not clinical factors were the primary correlates of device acceptance, which underlines the importance of taking into account the patient's psychological profile when seeking to identify patients at risk for adjustment difficulties after ICD implantation.

Economic evaluation of remote monitoring of patients with an implantable cardiac defibrillator (REMOTE-CIED study).

INTRODUCTION: Remote patient monitoring (RPM) of heart failure patients has the potential to reduce healthcare resource use and costs, but current evidence has been inconclusive. This study aims assess the impact of RPM of heart failure patients with an implantable cardioverter defibrillator on medical resource use, direct medical costs, quality-adjusted life years (QALYs), and travel time of patients, and to estimate its commercial headroom in the Netherlands and Germany. METHODS: Data from the REMOTE-CIED randomized controlled trial were used to calculate differences in length of hospital stay, outpatient clinic visits, telephone consults, emergency room visits, and travel time between patients on in-clinic follow-up and RPM in the Netherlands, Germany, and France. Incremental cardiac-related healthcare costs and QALYs were calculated and used to calculate the commercial headroom of RPM in the Netherlands and Germany. The impact of imputation, parameter, and case-mix uncertainty on these outcomes was explored using probabilistic analysis. RESULTS: Length of hospitalization, number of unscheduled admissions, and number of outpatient visits were lower in the remote monitoring group in all three countries. Number of hospital admissions was higher, and number of calls was lower in the Netherlands and Germany but not in France. Costs were lower in both the Netherlands (-€1041, 95% confidence interval (CI): -€3308, €1005) and Germany (-€2865, 95% CI: -€7619, €1105), while incremental effectiveness differed: -0.003 (95% CI: -0.114, 0.107) QALY in the Netherlands and +0.086 (95% CI: -0.083, 0.256) in Germany. Commercial headroom was estimated at €881 (95% CI: -€5430, €7208) in the Netherlands and €5005 (95% CI: -€1339, €11,960) in Germany. DISCUSSION: RPM was found to result in reduced medical resource use and travel time. Whether it is cost saving or cost effective strongly depends on the costs of remote monitoring. TRIAL REGISTRATION NUMBER AND TRIAL REGISTER: ClinicalTrials.gov: NCT01691586.

Patient-reported outcomes in Danish implantable cardioverter defibrillator patients with a Sprint Fidelis lead advisory notification.

AIMS: Few studies have investigated the association between implantable cardioverter defibrillators (ICDs) and lead advisory notifications and patient-reported outcomes (PROs). We examined (i) whether the mode used to inform patients about a device advisory is associated with PROs, and (ii) whether patients with a lead subject to a device advisory report poorer PROs than non-advisory controls. METHODS AND RESULTS: Patients (n= 207) implanted with an ICD at Aarhus University Hospital, Denmark, with a Sprint Fidelis lead subject to an advisory and a non-advisory control group (n= 510), completed a set of standardized PRO measures. A Bonferroni correction was applied to all statistical PRO comparisons to adjust for multiple comparisons, with a P-value of 0.0038 (0.05/13 PROs) indicating statistical significance. Device advisory patients did not differ significantly on PROs according to mode of notification (all P-values >0.0038). They also did not differ significantly from controls on mean scores of depression, anxiety, device acceptance, and health status (all P > 0.0038). Differences were only found on ICD concerns (P< 0.0001) and on mental health status (P = 0.003), with advisory patients reporting fewer ICD concerns and a better mental health status than non-advisory controls. CONCLUSIONS: The mode used to inform ICD patients about the advisory was not associated with PROs, nor was the overall well-being of device advisory patients impaired compared to non-advisory controls. These results indicate that ICD patients are generally able to cope with a device advisory.

Patient-rated health status predicts prognosis following percutaneous coronary intervention with drug-eluting stenting.

PURPOSE: In patients treated with percutaneous coronary intervention (PCI) with the paclitaxel-eluting stent, we examined whether patient-rated health status predicts adverse clinical events. METHODS: Consecutive PCI patients treated with drug-eluting stenting (N = 870; 72.2% men; mean age = 62.6 ± 11.5) completed the EQ-5D post-PCI. The EQ-5D levels were dichotomized into 'no problems' (level 1) versus 'problems' (levels 2, 3); the visual analogue scale (VAS) was dichotomized using the 25th percentile (cut-off ≤60) indicating poor health status. Patients were followed up for 1-year clinical events (death or non-fatal myocardial infarction (MI)). RESULTS: There were 53 deaths/MIs at follow-up. The EQ-5D health status dimensions mobility (HR:2.23; 95% CI:1.25-3.97), self-care (HR:3.09; 95% CI:1.54-6.20), and self-reported health status as measured with the EQ-VAS (HR:2.94; 95% CI:1.65-5.25) were independent predictors of death/MI and added to the predictive value of a model comprised of demographic and clinical characteristics. The EQ-5D dimensions usual activities, pain/discomfort, and anxiety/depression were not associated with adverse clinical events in adjusted analysis. CONCLUSIONS: Patient-rated health status predicted adverse clinical events at 1-year follow-up in PCI patients treated with drug-eluting stenting, with the risk being more than 2-fold independent of disease severity and other demographic and clinical characteristics. It may be timely to adopt standard assessment of health status in clinical practice.

Response to cardiac resynchronization therapy: is it time to expand the criteria?

BACKGROUND: Cardiac resynchronization therapy (CRT) is a promising treatment for a subgroup of patients with advanced congestive heart failure and a prolonged QRS interval. Despite the majority of patients benefiting from CRT, 10-40% of patients do not respond to this treatment and are labeled as nonresponders. Given that there is a lack of consensus on how to define response to CRT, the purpose of this viewpoint is to discuss currently used definitions and their shortcomings, and to provide recommendations as to how an expansion of the criteria for CRT response may be useful to clinicians. METHODS AND RESULTS: Analysis of the literature and case reports indicates that the majority of established measures of CRT response, including New York Heart Association functional class and echocardiographic, hemodynamic, and neurohormonal parameters, are poor associates of patient-reported symptoms and quality of life. Moreover, the potential moderating role of psychological factors in determining health outcomes after CRT has largely been neglected. CONCLUSIONS: It is recommended to routinely assess health status after CRT with a disease-specific questionnaire in standard clinical practice and to examine its determinants, including psychological factors such as personality traits and depression. This may lead to improved (secondary) treatment and prognosis in CHF patients treated with CRT.

Negative and positive affect are independently associated with patient-reported health status following percutaneous coronary intervention.

PURPOSE: We examined the association between negative and positive affect and 12-month health status in patients treated with percutaneous coronary intervention (PCI) with drug-eluting stents. METHODS: Consecutive PCI patients (n = 562) completed the Global Mood Scale at baseline to assess affect and the EuroQoL-5D (EQ-5D) at baseline and 12-month follow-up to assess health status. RESULTS: Negative affect [F(1, 522) = 17.14, P < .001] and positive affect [F(1, 522) = 5.11, P = .02] at baseline were independent associates of overall health status at 12-month follow-up, adjusting for demographic and clinical factors. Moreover, there was a significant interaction for negative by positive affect [F(1, 522) = 6.11, P = .01]. In domain-specific analyses, high negative affect was associated with problems in mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with the risk being two to fivefold. Low positive affect was only associated with problems in self-care (OR: 8.14; 95% CI: 1.85-35.9; P = .006) and usual activities (OR: 1.87; 95% CI: 1.17-3.00; P = .009). CONCLUSIONS: Baseline negative and positive affect contribute independently to patient-reported health status 12 months post PCI. Positive affect moderated the detrimental effects of negative affect on overall health status. Enhancing positive affect might be an important target to improve patient-centered outcomes in coronary artery disease.

Social inhibition and emotional distress in patients with coronary artery disease: The Type D personality construct.

We examined the validity of the social inhibition component of Type D, its distinctiveness from negative affectivity, and value regarding emotional distress as measured with the DS14 in 173 coronary artery disease patients. In dimensional analysis, social inhibition and negative affectivity emerged as distinct traits. Analysis of continuous negative affectivity and social inhibition measures showed main effects for several emotional and inhibition markers and an interaction effect for social anxiety. Categorical analysis indicated that Type D patients reported more depression, negative mood, social anxiety, and less positive mood. Social inhibition is not a redundant trait, but has additional conceptual value.

Patient-reported causes of heart failure in a large European sample.

BACKGROUND: Patients diagnosed with chronic diseases develop perceptions about their disease and its causes, which may influence health behavior and emotional well-being. This is the first study to examine patient-reported causes and their correlates in patients with heart failure. METHODS: European heart failure patients (N = 595) completed questionnaires, including the Brief Illness Perceptions Questionnaire. Using deductive thematic analysis, patient-reported causes were categorized into physical, natural, behavioral, psychosocial, supernatural and other. Clinical data were collected from medical records. RESULTS: Patients who did not report any cause (11%) were on average lower educated and participated less often in cardiac rehabilitation. The majority of the remaining patients reported physical causes (46%, mainly comorbidities), followed by behavioral (38%, mainly smoking), psychosocial (35%, mainly (work-related) stress), and natural causes (32%, mainly heredity). There were socio-demographic, clinical and psychological group differences between the various categories, and large discrepancies between prevalence of physical risk factors according to medical records and patient-reported causes; e.g. 58% had hypertension, while only 5% reported this as a cause. Multivariable analyses indicated trends towards associations between physical causes and poor health status (Odds ratio (OR) = 1.41, 95% confidence interval (95% CI) = 0.95-2.09, p = 0.09), psychosocial causes and psychological distress (OR = 1.54, 95% CI = 0.94-2.51, p = 0.09), and behavioral causes and a less threatening view of heart failure (OR = 0.64, 95% CI = 0.40-1.01, p = 0.06). CONCLUSION: European patients most frequently reported comorbidities, smoking, stress, and heredity as heart failure causes, but their causal understanding may be limited. There were trends towards associations between patient-reported causes and health status, psychological distress, and illness perceptions.

Prevalence and risk markers of early psychological distress after ICD implantation in the European REMOTE-CIED study cohort.

BACKGROUND: Evidence on psychological distress in patients living with an implantable cardioverter defibrillator (ICD) is inconclusive. The current study is the first to examine the prevalence and risk markers of anxiety and/or depression in a large international cohort of European ICD patients with or without cardiac resynchronization therapy (CRT). METHOD: Heart failure patients (N=569) from France, Germany, Spain, Switzerland and the Netherlands participating in the REMOTE-CIED study completed a set of questionnaires 1-2weeks post ICD-implantation, including the 7-item Generalized Anxiety Disorder scale and the 9-item Patient Health Questionnaire to assess anxiety and depressive symptoms, respectively. Patients' clinical data were obtained from their medical records. RESULTS: The prevalence of anxiety was 16% and that of depression 19%, with 25% of patients reporting one or both types of distress. Multivariable logistic regression analysis showed that age <60years (odds ratio (OR)=2.5[95% confidence interval=1.2-5.0]), having a threatening view of heart failure (OR=4.7[2.7-8.2]), a high level of ICD-related concerns (OR=2.9[1.7-5.1]), Type D personality (OR=2.4[1.3-4.4]), poor patient-reported health status (OR=2.2[1.3-3.9]) and receiving psychotropic medication (OR=3.0[1.5-5.9]) were positively associated with distress, while attending cardiac rehabilitation (OR=0.3[0.2-0.7]) was negatively associated with distress. CONCLUSIONS: A significant subset of European ICD and CRT-defibrillator patients reports anxiety and/or depression in the first weeks post implantation. Patients' psychological characteristics, especially negative perceptions about their illness and treatment, were the strongest associates of distress. Timely identification of these patients is essential as they may benefit from psychological interventions and cardiac rehabilitation in terms of improved quality of life and prognosis.