"Doubtful accepting": A grounded theory study of living with cardiac resynchronization therapy.

Heart failure is associated with low quality of life and a high mortality rate. There is limited information about patients' experiences of living with cardiac resynchronization therapy (CRT). In the present study, we sought to explore the process of living with CRT defibrillator. This qualitative study was completed from December 2014 to April 2016 using a grounded theory approach. Twenty semistructured interviews were held with 17 patients with heart failure. Data analysis was done via a previously-published approach. The core category of the process of living with the device is "doubtful accepting". This process includes three sequential phases: losing integrity, attempting to cope with the device, and coexisting. The process takes place in a context of barriers and facilitators, and results in a wide spectrum of outcomes, from frustration to empowerment. Nurses' awareness of this process can help them provide higher quality care, strengthen facilitators and reduce barriers to the process, and enable patients to effectively use coping strategies.

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.

The Post-Myocardial Infarction Pacing Remodeling Prevention Therapy (PRomPT) Trial: Design and Rationale.

BACKGROUND: Despite considerable improvements in the medical management of patients with myocardial infarction (MI), patients with large MI still have substantial risk of developing heart failure. In the early post-MI setting, implantable cardioverter defibrillators have reduced arrhythmic deaths but have no impact on overall mortality. Therefore, additional interventions are required to further reduce the overall morbidity and mortality of patients with large MI. METHODS: The Pacing Remodeling Prevention Therapy (PRomPT) trial is designed to study the effects of peri-infarct pacing in preventing adverse post-MI remodeling. Up to 120 subjects with peak creatine phosphokinase >3,000 U/L (or troponin T >10 µg/L) at time of MI will be randomized to either dual-site or single-site biventricular pacing with the left ventricular lead implanted in a peri-infarct region or to a nonimplanted control group. Those randomized to a device will be blinded to the pacing mode, but randomization to a device or control cannot be blinded. Subjects randomized to pacing will have the device implanted within 10 days of MI. The primary objective is to assess the change in left ventricular end-diastolic volume from baseline to 18 months. Secondary objectives are to assess changes in clinical and mechanistic parameters between the groups, including rates of hospitalization for heart failure and cardiovascular events, the incidence of sudden cardiac death and all-cause mortality, New York Heart Association functional class, 6-minute walking distance, and quality of life. CONCLUSIONS: The PRomPT trial will provide important evidence regarding the potential of peri-infarct pacing to interrupt adverse remodeling in patients with large MI.

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.

The Registry Evaluating Functional Outcomes of Resynchronization Management (REFORM): quality of life and psychological functioning in patients receiving cardiac resynchronization therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) is a treatment for heart failure (HF) that improves cardiac, functional, and quality of life (QoL) outcomes. This study was designed to examine the effect of the addition of CRT (CRTD) to the implantable cardioverter defibrillator (ICD) on psychological functioning. METHODS AND RESULTS: Overall, 99 participants completed batteries before and 9 months after ICD or CRTD implantation in a registry of HF patients receiving device treatment in 3 US centers. Measures included validated indices of mental health (State Trait Anxiety Inventory, Patient Health Questionnaire: Depression) and generic and disease/device-specific QoL (Medical Outcomes Study-Short Form-12, Kansas City Cardiomyopathy Questionnaire, Florida Patient Acceptance Survey, Florida Shock Anxiety Scale). Mixed between-within analyses of covariance were employed to compare device groups on each outcome controlling for cardiac and demographic covariates. Clinically significant anxiety was elevated in both groups at both time points (57% CRTD at baseline, 29% CRTD 9 months, 44% ICD at baseline, 45% ICD 9 months). Clinically significant depressive symptoms were high at baseline (38% CRTD, 31% ICD), but dropped at follow-up (16% CRTD, 7% ICD; P = 0.01). Participants with CRTD had improved mental component and disease-specific QoL following CRT; however, CRTD patients had worse QoL, worse mental component QoL at baseline, and worse device acceptance at 9-month follow-up than patients with ICDs (all P < 0.05). CONCLUSIONS: Evidence of low QoL, psychological functioning, and device acceptance provides the impetus to increase research on well-being of HF patients being implanted with CRTD in research and clinical work.

Depression, psychological distress, and quality of life in patients with cardioverter defibrillator with or without cardiac resynchronization therapy.

Congestive heart failure is frequent and leads to reduced exercise capacity, reduced quality of life (QoL), and depression in many patients. Cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillators (ICD) offer therapeutic options and may have an impact on QoL and depression. This study was performed to evaluate physical and mental health in patients undergoing ICD or combined CRT/ICD-implantation (CRT-D). Echocardiography, spiroergometry, and psychometric questionnaires [Beck Depression Inventory, General World Health Organization Five Well-being Index (WHO-5), Brief Symptom Inventory and 36-item Short Form (SF-36)] were obtained in 39 patients (ICD: 17, CRT-D: 22) at baseline and 6-month follow-up (FU) after device implantation. CRT-D patients had a higher NYHA class and broader left bundle branch block than ICD patients at baseline. At FU, ejection fraction (EF), peak oxygen uptake, and NYHA class improved significantly in CRT-D patients but remained unchanged in ICD patients. Patients with CRT-D implantation showed higher levels of depressive symptoms, psychological distress, and impairment in QoL at baseline and FU compared to ICD patients. These impairments remained mostly unchanged in all patients after 6 months. Overall, these findings imply that there is a need for careful assessment and treatment of psychological distress and depression in ICD and CRT-D patients in the course of device implantation as psychological burden seems to persist irrespective of physical improvement.

Anxiety and risk of ventricular arrhythmias or mortality in patients with an implantable cardioverter defibrillator.

OBJECTIVE: A subgroup of patients with an implantable cardioverter defibrillator (ICD) experiences anxiety after device implantation. The purpose of the present study was to evaluate whether anxiety is predictive of ventricular arrhythmias and all-cause mortality 1 year post ICD implantation. METHODS: A total of 1012 patients completed the state version of the State-Trait Anxiety Inventory at baseline. The end points were ventricular arrhythmias and mortality the first year after ICD implantation. RESULTS: Within the first year after ICD implantation, 19% of patients experienced a ventricular arrhythmia, and 4% died. Anxiety was associated with an increased risk of ventricular arrhythmias (hazard ratio [HR] = 1.017; 95% confidence interval [CI] = 1.005-1.028; p = .005) and mortality (HR = 1.038; 95% CI = 1.014-1.063; p = .002) in adjusted analysis. Patients with anxiety (highest tertile) had a 1.9 increased risk for ventricular arrhythmias (95% CI = 1.329-2.753; p =.001) and a 2.9 increased risk for mortality (95% CI = 1.269-6.677; p = .01) compared with patients with low anxiety (lowest tertile). Among 257 patients with cardiac resynchronization therapy, anxiety was associated with mortality (HR = 5.381; 95% CI = 1.254-23.092; p = .02) after adjusting for demographic and clinical covariates. CONCLUSIONS: Anxiety was associated with an increased risk of ventricular arrhythmias and mortality 1 year after ICD implantation, independent of demographic and clinical covariates. Monitoring and treatment of anxiety may be warranted in a selected subgroup of high-risk patients with an ICD.

[Quality of life in patients after anti-arrhythmic devices implantation]. / Jakosc zycia chorych po implantacji wszczepialnych urzadzén antyarytmicznych.

THE AIM OF STUDY: To assess changes in quality of life in patients with advanced heart failure before ICD or CRTD implantation and after 6 months follow-up period. MATERIAL AND METHODS: The quality of life study was performed in group consisting of 98 patients (69 male, mean age 70.4 +/- 8.60 years), who underwent CRTD implantation (48 patients, 33 male, mean age 70.6 +/- 9.12 years) or ICD implantation (50 patients, 36 male, mean age 70.3 +/- 8.16 years) before the procedure and after 6 months of follow-up. Inclusion criteria were as follows: patients with indications to ICD or CRTD implantation, complete quality of life questionnaires before the procedure and after 6 months follow-up, lack of diagnosed dementia. The quality of life assessment was performed using patient's self-assessment with SF-36 and DASI questionnaires. Patients' self-assessment, NYHA class and ejection fraction was compared before the implantation and after 6 months. Additionally, co-morbidities and experiencing of high voltage therapy were analyzed. RESULTS: In the whole group after 6 months NYHA class improved from mean 2.9 +/- 0.5 to 2.3 +/- 0.84, p < 0.001; in CRTD group from mean 3.0 +/- 0.62 to 2.3 +/- 0.95, p < 0.001; in ICD group from mean 2.9 +/- 0.35 to 2.2 +/- 0.74, p < 0.001. In the whole group after 6 months ejection fraction improved from mean 27.7 +/- 6.92 to 31.0 +/- 7.23%, p < 0.001; in CRTD group from mean 25.3 +/- 7.85 to 32.4 +/- 8.98%, p < 0.001; in ICD group there was no significant improvement of ejection fraction. After CRTD implantation improvement of quality of life was achieved in SF36 and DASI questionnaires. There was no significant improvement in ICD group. DASI index is deteriorated by device's interventions (cardioversions) (regression index=3.45, odds ratio OR = 31.5, 95% confidence interval OR = 8.2-121, p < 0.001) and presence of permanent atrial fibrillation (regression index = 1,243, odds ratio OR = 3.45, 95% confidence interval OR = 1.03-11.7, p < 0.042). SF36 index is deteriorated by presence of kidney failure (regression index = 1.91, odds ratio OR = 6.74, 95% confidence interval OR = 1.75-26, p < 0.005) and permanent atrial fibrillation (regression index = 2.27, odds ratio OR = 9.7, 95% confidence interval OR = 3.1-29.6, p < 0.001). CONCLUSIONS: Cardiac resynchronization therapy (CRTD) improves quality of life, NYHA class and left ventricle ejection fraction. Implantable cardioverter-defibrillator (ICD) does not significantly improve quality of life, NYHA class or left ventricle ejection fraction. Only in the CRTD group a significant positive correlation between changes in DASI and SF36 indexes and left ventricle ejection fraction was achieved. Experiencing cardioversion/defibrillation from implantable device and co morbidities (diabetes mellitus, arterial hypertension, kidney failure, permanent atrial fibrillation) significantly deteriorate patients' self assessment of quality of life.

Cardiac resynchronization and quality of life in patients with minimally symptomatic heart failure.

OBJECTIVES: This study compared the quality of life (QOL) of patients with cardiac resynchronization therapy (CRT) and an implantable cardioverter-defibrillator (ICD) to patients with an ICD only. BACKGROUND: CRT with ICD is associated with a reduction in heart failure risk among minimally symptomatic patients. It is unknown whether this improves QOL. METHODS: This study uses the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) data. The MADIT-CRT enrolled 1,820 patients at 110 centers across 14 countries. Patients had ischemic cardiomyopathy (New York Heart Association [NYHA] functional class I or II) or nonischemic cardiomyopathy (NYHA functional class II only), sinus rhythm, an ejection fraction of 30% or less, and prolonged intraventricular conduction with a QRS duration of 130 ms or more. QOL was evaluated on the 1,699 patients with baseline and follow-up measures using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Six dimensions (Physical Limitation, Symptom Stability, Symptom Frequency, Symptom Burden, Quality of Life, and Social Limitations) and 3 summary scores (Total Symptom, Clinical Summary, and Overall Summary) were analyzed. RESULTS: During an average follow-up of 2.4 years, the CRT-ICD group had greater improvement than the ICD-only group on all KCCQ measures (p < 0.05 on each scale). These differences were significant among patients with left bundle branch block conduction disturbance (n = 1,204, p < 0.01 on each scale), but not among patients without left bundle branch block (n = 494). CONCLUSIONS: Compared with patients with ICD only, CRT-ICD is associated with greater improvement in QOL among relatively asymptomatic patients, specifically among those with left bundle branch conduction disturbance.

Cost-effectiveness of cardiac resynchronization therapy: perspective from Argentina.

OBJECTIVES: Cardiac resynchronization therapy (CRT) has recently been shown to reduce both mid-term and long-term mortality in patients with mild heart failure. Although proven effective, it is unclear whether CRT is cost-effective in low and middle-income countries (LMIC). Therefore, we set out to analyze the cost-effectiveness of CRT in Argentina in patients with New York Heart Association (NYHA) functional class (FC) I or II heart failure (HF). We chose to compare patients receiving optimal medical treatment (OMT) and CRT with those patients receiving only OMT. METHODS: We constructed a Markov model with a cohort simulation, and a life-time horizon to assess costs, life-years, and quality-adjusted life-year (QALY) gained as a result of treatment with both CRT and OMT from an Argentine third party payer perspective. We included patients who met the following criteria: left ventricular ejection fraction (LVEF) ≤ 40 percent, sinus rhythm with a QRS ≥ 120 msec, and NYHA FC I-II HF. The results were expressed as cost per life-year and QALY gained in international dollars (ID$) for the year 2009. RESULTS: For the base case analysis performed, we started at a fixed age of 65. After applying a 3 percent annual discount rate, the incremental cost-effectiveness ratio (ICER) was 38.005 ID$ per year of life gained and 34.185 ID$ per QALY gained. CONCLUSIONS: Long-term treatment with CRT appears to be cost-effective in Argentina compared with patients treated solely with OMT. Similar analysis should be performed to determine if this treatment option is cost-effective in other LMIC.

Mood disorders and outcome in patients receiving cardiac resynchronization therapy.

BACKGROUND: Mood disorders (MD) have been demonstrated to influence outcome in cardiac disease in general and specifically in chronic heart failure (HF). Little is known about their possible effect on response to cardiac resynchronization therapy (CRT). OBJECTIVE: To evaluate the influence of MD on CRT response. METHODS: We conducted a retrospective chart review of all cardiac CRT-D (CRT defibrillator) recipients (N = 153) at the Veterans Affairs Pittsburgh Healthcare System from beginning of 2004 through end of 2006. All-cause death and HF-related hospitalizations (HFH), individually and combined, were sought through 2009. RESULTS: During a mean follow-up time of 31.4 ± 14.7 months, there were 48 (31.4%) deaths and 55 (35.9%) HFHs in HF patients having New York Heart Association class of 2.9 ± 0.3, left ventricular ejection fraction (LVEF) of 25.8 ± 9.1%, left ventricular end-diastolic diameter (LVEDD) of 61.6 ± 11.6 mm, and QRS of 152 ± 30.5 ms . A total of 65 (42.5%) patients had MD (depression, anxiety, or posttraumatic stress disorder). Compared to others, patients in the MD group were at a significantly higher risk of HFH alone (47.7% vs 27.3%, P = 0.009) or when combined with death (58.5% vs 39.8%, P = 0.022) but not death alone (35.4% vs 28.4%, P = 0.36). The significant predictive effect of MD on HFH alone and when combined with death shown in univariate analysis was not attenuated after adjustment for age, ejection fraction, etiology of cardiomyopathy, cumulative number of any shocks, smoking, and evidence of postimplantation echocardiographic improvement. CONCLUSIONS: MD in patients with advanced but stable HF receiving CRT-D therapy was a predictor of HFH alone or when combined with death but not mortality alone.