Krista C. van den Broek

Risk of ventricular arrhythmia after implantable defibrillator treatment in anxious Type D patients

OBJECTIVES We sought to examine the combination of adverse psychological factors (anxiety, depression, and distressed or Type D personality) as a predictor of ventricular arrhythmias in patients with implantable cardioverter-defibrillators (ICDs). BACKGROUND Little is known about the role of psychological factors and their clustering in the occurrence of life-threatening arrhythmias. METHODS In this prospective study, 391 patients with an ICD (81% men, age 62.3 +/- 10.4 years) completed anxiety, depression, and Type D personality scales at the time of implantation. The end point was occurrence of ventricular arrhythmia, defined as appropriate ICD therapies, in the first year after implantation. RESULTS Ventricular arrhythmias occurred in 19% (n = 75) of patients. Increased symptoms of depression (p = 0.81) or anxiety (p = 0.31) did not predict arrhythmias. However, anxious patients with a Type D personality had a significantly increased rate of ventricular arrhythmias (21 of 71; 29.6%) as compared with other ICD patients (54 of 320; 16.9%; hazard ratio [HR]: 1.89; 95% confidence interval [CI]: 1.14 to 3.13; p = 0.013). When controlled for the effects of sex, age, ischemic etiology, left ventricular dysfunction, prolonged QRS duration, and medication, anxious Type D patients (HR: 1.72; 95% CI: 1.03 to 2.89; p = 0.039) and secondary prevention patients (HR: 1.91; 95% CI: 1.14 to 3.20; p = 0.014) were at increased risk of ventricular arrhythmias. CONCLUSIONS Personality modulated the effect of emotional distress; anxiety predicted a 70% increase in risk of arrhythmia in Type D patients but not in other patients. Anxious Type D patients may be identified and offered additional behavioral support after ICD implantation.

Pre-implantation implantable cardioverter defibrillator concerns and Type D personality increase the risk of mortality in patients with an implantable cardioverter defibrillator

AIMS Little is known about the influence of psychological factors on prognosis in implantable cardioverter defibrillator (ICD) patients. We examined the influence of the distressed personality (Type D) and pre-implantation device concerns on short-term mortality in ICD patients. METHODS AND RESULTS Consecutively implanted ICD patients (N = 371; 79.5% men) completed the Type D Scale and the ICD Patient Concerns questionnaire prior to implantation and were followed up for short-term mortality. The prevalence of Type D was 22.4%, whereas 34.2% had high levels of ICD concerns. The incidence of mortality was higher in Type D vs. non-Type D patients [13.3% vs. 4.92%; hazard ratio (HR): 2.74; 95% confidence interval (CI): 1.24-6.03] and in patients with high vs. low levels of ICD concerns (11.0% vs. 4.5%; HR: 2.38; 95% CI: 1.08-5.23). Type D personality (HR: 2.79; 95% CI: 1.25-6.21) and high levels of ICD concerns (HR: 2.38; 95% CI: 1.06-5.34) remained independent predictors of mortality in separate analyses, adjusting for sex, age, ICD indication, coronary artery disease, and shocks. Patients with clustering of both Type D personality and high levels of pre-implantation concerns (HR: 3.86; 95% CI: 1.64-9.10) had a poorer survival compared with patients with one or none of these risk markers in adjusted analysis. Shocks during the follow-up period were also associated with mortality (HR: 3.09; 95% CI: 1.36-7.04). CONCLUSION Patients with a distressed personality and high levels of pre-implantation device-related concerns had a poorer prognosis, independent of other risk markers including shocks. This subgroup of patients should be identified in clinical practice and would likely benefit from a combined distress management programme and cardiac rehabilitation.

Risk of chronic anxiety in implantable defibrillator patients: A multi-center study

BACKGROUND Little is known about the prevalence of chronic anxiety in patients with an implantable cardioverter defibrillator (ICD). In a multi-center, prospective study, we examined 1) the prevalence of chronic anxiety (i.e., patients anxious at implantation and 12 months), and 2) predictors of chronic anxiety. METHODS ICD patients (N=284; 21.1% women) anxious (cut-off ≥ 40 on the State Trait Anxiety Inventory (STAI)) at the time of implantation qualified for inclusion in the current study. Patients completed the Type D Scale at baseline and the STAI (state measure) at baseline and 12 months. RESULTS Of 284 patients anxious at baseline, 53.9% (153/284) remained anxious at 12-month follow-up. Diabetes (OR:2.49; 95%CI:1.16-5.36), cardiac resynchronization therapy (CRT) (OR:2.03; 95%CI:1.02-4.05), and Type D personality (OR:1.87; 95%CI:1.09-3.19) were independent predictors of 12-month anxiety, adjusting for demographic and clinical variables including ICD therapy during follow-up. Shocks (both appropriate and inappropriate during follow-up) were not associated with chronic anxiety at 12 months (OR:0.94; 95%CI:0.42-2.12). The prevalence of chronic anxiety in the 96 patients with no risk factors was 34.4% and 63.8% in the 120 patients with either diabetes, CRT, or Type D personality. CONCLUSIONS More than 50% of ICD patients anxious at the time of implantation were still anxious at 12 months, indicating a high level of chronicity. Diabetes, CRT, and Type D personality were independent predictors of chronic anxiety. ICD patients anxious at implantation should be closely monitored and offered adjunctive psychosocial intervention if symptoms do not remit spontaneously in order to prevent adverse health outcomes.

Does ICD indication affect quality of life and levels of distress

The implantable cardioverter defibrillator (ICD) is the treatment of choice for life‐threatening arrhythmias, with ICD indications having recently been extended to include primary prophylaxis. Despite the medical benefits of the ICD, there is an ongoing debate as to the impact of the ICD on patients’ lives, particularly whether primary prophylaxis implantation may impact adversely on patient‐centered outcomes such as quality of life (QoL) and distress. We examined the evidence for a role of ICD indication on these patient‐centered outcomes. A literature search was conducted on PubMed and Web of Science from 2002 to present, focusing on indication for ICD therapy and patient‐centered outcomes (i.e., anxiety, depression, disease‐specific, or general QoL). We identified five studies (seven articles) concerning the impact of indication on patient‐centered outcomes. Sample sizes varied from 91–426 patients across studies, five of seven articles used a prospective design, and follow‐up ranged from 2–12 months. No study reported an effect for indication on patient‐centered outcomes. There is no evidence to suggest that patients receiving an ICD for primary prophylaxis have subsequent poorer QoL and greater distress than patients receiving an ICD for secondary prophylaxis. This knowledge may help cardiologists in the clinical management of patients, in particular when discussing ICD implantation with patients.

Shock as a Determinant of Poor Patient-Centered Outcomes in Implantable Cardioverter Defibrillator Patients: Is There More to It Than Meets the Eye?

The medical benefits of the implantable cardioverter defibrillator (ICD) are well established, but ICD shocks are known to influence patient‐centered outcomes. In this viewpoint, we examine the strength of the evidence as found in primary and secondary prevention trials that used quality of life as an outcome, and compare the influence of ICD shock with other factors (e.g., heart failure and psychological factors) as determinants of outcomes, with a view to providing recommendations for clinical practice and future research. Based on the large‐scale primary and secondary prevention trials (i.e., CABG‐PATCH, CIDS, AVID, AMIOVIRT, SCD‐HeFT, MADIT‐II, and DEFINITE), evidence for an association between ICD shocks and quality of life is mixed, with some indication that the influence of shocks may depend largely on the interval between shocks and assessment of quality of life. In order to improve the clinical management of ICD patients, we need to adopt a more rigorous and standardized methodology in future studies in order to be able to draw firm conclusions about the impact of ICD shocks on individual patients. We also need to acknowledge that the impact of shocks on psychological functioning and quality of life may not be as straightforward as previously assumed. Given that programming of the ICD is changing, leading to fewer shocks and improved quality of life, it may be timely to also examine the influence of other determinants (e.g., heart failure progression and the patients psychological profile) of patient‐centered outcomes both in research and in clinical practice. (PACE 2010; 33:1430–1436)

Psychological reaction to potential malfunctioning of implantable defibrillators

Background: Psychological problems following implantable cardioverter defibrillators (ICD) implantation are diverse and include increased levels of anxiety. Anxiety may even rise further when possible malfunctioning of an ICD is announced, with a higher risk of serious ventricular arrhythmias and death as a consequence. Following the public statement of Medtronic, all patients in the Netherlands with the specific Medtronic ICD were contacted for extra device evaluation. The aim of this exploratory study was to determine whether the proportion of ICD patients with high levels of anxiety would increase after this extra device evaluation.

Emotional distress, positive affect, and mortality in patients with an implantable cardioverter defibrillator

BACKGROUND Little is known about the relationship between emotional distress and mortality in patients with an implantable cardioverter defibrillator (ICD). Our aim was to examine the predictive value of general negative and positive affect, and depressive symptoms (including its components somatic symptoms and cognitive-affective symptoms) for mortality. METHODS ICD patients (N=591, 81% male, mean age=62.7 ± 10.1 years) completed the Global Mood Scale to measure the independent dimensions negative and positive mood, and the Beck Depression Inventory to measure depressive symptoms. Covariates consisted of demographic and clinical variables. RESULTS During the median follow-up of 3.2 years, 96 (16.2%) patients died. After controlling for covariates, negative affect was significantly related to all-cause mortality (HR=1.034, p=0.002), whereas positive affect was not (HR=1.007, p=0.61). Depressive symptoms were also independently associated with an increased mortality risk (HR=1.031, p=0.030) and somatic symptoms of depression in particular (HR=1.130, p=0.003), but cognitive-affective symptoms were not associated with mortality (HR=0.968, p=0.29). When entering both significant psychological predictors in a covariate-adjusted model, negative mood remained significant (HR=1.039, p=0.009), but somatic symptoms of depression did not (HR=0.988, p=0.78). Similar results were found for cardiac-related death. Of covariates, increased age, CRT, appropriate shocks were positively related to death. CONCLUSIONS Negative affect in general was related to mortality, but reduced positive affect was not. Depression, particularly its somatic symptoms, was also related to mortality, while cognitive-affective symptoms were not. Future research may further focus on the differential predictive value of emotional distress factors, as well as on mechanisms that relate emotional distress factors to mortality.

Rationale and design of WEBCARE: A randomized, controlled, web-based behavioral intervention trial in cardioverter-defibrillator patients to reduce anxiety and device concerns and enhance quality of life

BackgroundThe implantable cardioverter defibrillator (ICD) is generally well accepted, but 25-33% of patients experience clinical levels of anxiety, depression, and impaired quality of life (QoL) following implantation. Few trials in ICD patients have investigated whether behavioral intervention may mitigate the development of these adjustment problems. We present the rationale and study design of the WEB-based distress management program for implantable CAR dioverter dE fibrillator patients (WEBCARE) trial.MethodsWEBCARE is a multi-center, multi-disciplinary, randomized, controlled behavioral intervention trial designed to examine the effectiveness of a web-based approach in terms of reducing levels of anxiety and device concerns and enhancing QoL. Consecutive patients hospitalized for the implantation of an ICD will be approached for study participation while in hospital and randomized to the intervention arm (n = 175) versus usual care (n = 175) at baseline (5-10 days post implantation). Patients will complete assessments of patient-centered outcomes at baseline, 14, 26, and 52 weeks after implantation. Patients randomized to the intervention arm will receive a 12-week web-based behavioral intervention starting 2 weeks after implantation. Primary endpoints include (ii) patient-centered outcomes (i.e., anxiety, depression, ICD acceptance, QoL); (iii) health care utilization; and (iiii) cost-effectiveness. All primary endpoints will be assessed with standardized and validated disease-specific or generic questionnaires. Secondary endpoints include (iii) cortisol awakening response; and (iiii) ventricular arrhythmias.DiscussionWEBCARE will show whether a behavioral intervention using a web-based approach is feasible and effective in reducing anxiety and ICD concerns and improving QoL in ICD patients.Trial Registrationhttp://www.ClinicalTrials.gov. Identifier: NCT00895700.

Comparison of fatigue levels in patients with stroke and patients with end-stage heart failure: application of the fatigue assessment scale.

OBJECTIVES: To examine the assessment of fatigue using the Fatigue Assessment Scale (FAS) in patients with stroke and to compare the levels of fatigue reported by patients with stroke, patients with chronic heart failure (CHF), and healthy controls.

Association of Type D personality with unhealthy lifestyle, and estimated risk of coronary events in the general Icelandic population:

Background: Type D personality is associated with an increased morbidity and mortality risk in cardiovascular disease patients, but the mechanisms explaining this risk are unclear. We examined whether Type D was associated with coronary artery disease (CAD) risk factors, estimated risk of developing CAD, and previous cardiac events. Design: Cross-sectional study in the general Icelandic population. Methods: A random sample of 4753 individuals (mean age 49.1 ± 12.0 years; 49% men) from the REFINE-Reykjavik study completed assessments for Type D personality and conventional CAD risk factors. Ten-year risk of developing CAD was estimated with the Icelandic risk calculator. Results: Type D personality (22% of sample) was associated with a higher prevalence of hypertension (35 vs. 31%, p = 0.009), but less use of hypertension medication (58 vs. 65%, p = 0.013) in hypertensives, more diabetes (6 vs. 4%, p = 0.023), wider waist circumference (p = 0.007), and elevated body mass index (p = 0.025) and blood lipids (p < 0.05). Type D individuals reported less physical exercise (p = 0.000) and more current (26 vs. 21%, p = 0.003) and former smoking (48 vs. 44%, p = 0.036). Estimates of 10-year risk of CAD were higher in Type D individuals (12.4%, 95% CI 1.9 to 23.8%), and Type Ds reported more previous cardiac events than non-Type Ds (5 vs. 3%, p < 0.01; OR 1.71, 95% CI 1.21 to 2.42). Conclusions: In the general Icelandic population, Type D personality was associated with differences in lifestyle-related CAD risk factors, a higher estimated risk of developing CAD, and higher incidence of previous cardiac events. Unhealthy lifestyles may partly explain the adverse cardiovascular effect of Type D personality.