The prognostic value of quality of life in atrial fibrillation on patient value.

BACKGROUND: In this study, the prognostic value of AF-related quality of life (AFEQT) at baseline on Major Adverse Cardiovascular Events (MACE) and improvement of perceived symptoms (EHRA) was assessed. Furthermore, the relationship between QoL and AF-related hospitalizations was assessed. METHODS: A cohort of AF-patients diagnosed between November 2014 and October 2019 in four hospitals embedded within the Netherlands Heart Network were prospectively followed for 12 months. MACE was defined as stroke, myocardial infarction, heart failure and/or mortality. Subsequently, MACE, EHRA score improvement and AF-related hospitalizations between baseline and 12 months of follow-up were recorded. RESULTS: In total, 970 AF-patients were available for analysis. In analyses with patients with complete information on the confounder subset 36/687 (5.2%) AF-patients developed MACE, 190/432 (44.0%) improved in EHRA score and 189/510(37.1%) were hospitalized during 12 months of follow-up. Patients with a low AFEQT score at baseline more often developed MACE (OR(95%CI): 2.42(1.16-5.06)), more often improved in EHRA score (OR(95%CI): 4.55(2.45-8.44) and were more often hospitalized (OR(95%CI): 4.04(2.22-7.01)) during 12 months post diagnosis, compared to patients with a high AFEQT score at baseline. CONCLUSIONS: AF-patients with a lower quality of life at diagnosis more often develop MACE, more often improve on their symptoms and also were more often hospitalized, compared to AF-patients with a higher quality of life. This study highlights that the integration of patient-reported outcomes, such as quality of life, has the potential to be used as a prognostic indicator of the expected disease course for AF.

Age-dependency of EHRA improvement based on quality of life at diagnosis of atrial fibrillation.

BACKGROUND: In this study, the relationship between AF-related quality of life (AFEQT) at baseline in AF-patients and the improvement on perceived symptoms and general state of health (EHRA, European Heart Rhythm Association score) at 12 months was assessed across predefined age categories. METHODS: Between November 2014 and October 2019 patients diagnosed with AF de novo in four hospitals embedded within the Netherlands Heart Network were prospectively followed for 12 months. These AF-patients were categorized into quartiles based on their AFEQT score at diagnosis and EHRA score was measured at diagnosis and 12 months of follow-up. Stratified analyses were performed using age categories (<65 vs. ≥65 years; <75 vs. ≥75 years). RESULTS: In total, 203/483 (42.0%) AF-patients improved in EHRA score after 12 months of follow-up. AF-patients in the lowest AFEQT quartile were more likely to improve, compared to patients in the highest AFEQT quartile (OR [95%CI]:4.73 [2.63-8.50]). Furthermore, patients ≥65 years and patients <75 years at diagnosis with lower AFEQT scores at baseline were most likely to improve in EHRA score after 12 months, compared to similarly aged patients with higher AFEQT scores at baseline. CONCLUSION: The present study indicates that AF-patients with a lower quality of life at diagnosis were most likely to improve their EHRA score after 12 months. This effect was most prominent in patients ≥65 years of age and patients <75 years of age, compared to patients >65 and ≥75 years, respectively. Future research should focus on further defining characteristics of these age groups to enable the implementation of age-tailored treatment.

Persistent phrenic nerve palsy after atrial fibrillation ablation: Follow-up data from The Netherlands Heart Registration.

BACKGROUND: Persistent phrenic nerve palsy (PNP) is an established complication of atrial fibrillation (AF) ablation, especially during cryoballoon and thoracoscopic ablation. Data on persistent PNP reversibility is limited because most patients recover <24 h. This study aims to investigate persistent PNP recovery, freedom of PNP-related symptoms after AF ablation and identify baseline variables associated with the occurrence and early PNP recovery in a large nationwide registry study. METHODS: In this study, we used data from the Netherlands Heart Registration, comprising data from 9549 catheter and thoracoscopic AF ablations performed in 2016 and 2017. PNP data was available of 7433 procedures, and additional follow-up data were collected for patients who developed persistent PNP. RESULTS: Overall, the mean age was 62 ± 10 years, and 67.7% were male. Fifty-four (0.7%) patients developed persistent PNP and follow-up was available in 44 (81.5%) patients. PNP incidence was 0.07%, 0.29%, 1.41%, and 1.25%, respectively for patients treated with conventional-RF, phased-RF, cryoballoon, and thoracoscopic ablation respectively. Seventy-one percent of the patients fully recovered, and 86% were free of PNP-related symptoms after a median follow-up of 203 (113-351) and 184 (82-359) days, respectively. Female sex, cryoballoon, and thoracoscopic ablation were associated with a higher risk to develop PNP. Patients with PNP recovering ≤180 days had a larger left atrium volume index than those with late or no recovery. CONCLUSION: After AF ablation, persistent PNP recovers in the majority of patients, and most are free of symptoms. Female patients and patients treated with cryoballoon or thoracoscopic ablation are more prone to develop PNP.

Dutch Outcome in Implantable Cardioverter-Defibrillator Therapy: Implantable Cardioverter-Defibrillator-Related Complications in a Contemporary Primary Prevention Cohort.

Background One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. Methods and Results Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverter-defibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0-2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. Conclusions One in 13 patients experiences at least one major implantable cardioverter-defibrillator-related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits.

Development and external validation of prediction models to predict implantable cardioverter-defibrillator efficacy in primary prevention of sudden cardiac death.

AIMS: This study was performed to develop and externally validate prediction models for appropriate implantable cardioverter-defibrillator (ICD) shock and mortality to identify subgroups with insufficient benefit from ICD implantation. METHODS AND RESULTS: We recruited patients scheduled for primary prevention ICD implantation and reduced left ventricular function. Bootstrapping-based Cox proportional hazards and Fine and Gray competing risk models with likely candidate predictors were developed for all-cause mortality and appropriate ICD shock, respectively. Between 2014 and 2018, we included 1441 consecutive patients in the development and 1450 patients in the validation cohort. During a median follow-up of 2.4 (IQR 2.1-2.8) years, 109 (7.6%) patients received appropriate ICD shock and 193 (13.4%) died in the development cohort. During a median follow-up of 2.7 (IQR 2.0-3.4) years, 105 (7.2%) received appropriate ICD shock and 223 (15.4%) died in the validation cohort. Selected predictors of appropriate ICD shock were gender, NSVT, ACE/ARB use, atrial fibrillation history, Aldosterone-antagonist use, Digoxin use, eGFR, (N)OAC use, and peripheral vascular disease. Selected predictors of all-cause mortality were age, diuretic use, sodium, NT-pro-BNP, and ACE/ARB use. C-statistic was 0.61 and 0.60 at respectively internal and external validation for appropriate ICD shock and 0.74 at both internal and external validation for mortality. CONCLUSION: Although this cohort study was specifically designed to develop prediction models, risk stratification still remains challenging and no large group with insufficient benefit of ICD implantation was found. However, the prediction models have some clinical utility as we present several scenarios where ICD implantation might be postponed.

Clamping versus nonclamping thoracoscopic box ablation in long-standing persistent atrial fibrillation.

OBJECTIVE: To compare clinical outcomes of clamping devices and linear nonclamping devices for isolation of the posterior left atrium (box) in thoracoscopic ablation of long-standing persistent atrial fibrillation. METHODS: Eighty patients who underwent thoracoscopic pulmonary vein and box isolation using a bipolar clamping device (42 patients) or bipolar nonclamping device (38 patients) to create the roof/inferior lesions for box isolation were included from 2 centers. Follow-up consisted of 24-hour Holter at regular intervals. Freedom from AF during 1-year follow-up and catheter repeat interventions were compared between groups. RESULTS: Acute intraoperative electrical isolation of the box compartment was significantly higher in the clamping group than in the nonclamping group (100% and 79%, respectively, P < .01). At 1-year follow-up, 91% of the clamping group and 79% of the nonclamping group were in sinus rhythm. During 1-year follow-up, recurrence rates did not significantly differ between the 2 groups (P = .08). Repeat catheter interventions were required in 10% of the clamping group and 21% of the nonclamping group (P = .15). Conduction gaps in the roof or inferior lesions were found in 1 patient (2%) in the clamping group versus 4 patients (11%) in the nonclamping group (P = .13). CONCLUSIONS: Thoracoscopic pulmonary vein and box isolation are highly effective in restoring sinus rhythm in long-standing persistent atrial fibrillation on short-term follow-up. Comparison of clamping and nonclamping devices revealed lower rates of intraoperative exit block of the box in the nonclamping group. However, this did not translate into a significant difference in atrial fibrillation freedom at short-term (1-year) follow-up.

Web-based distress management for implantable cardioverter defibrillator patients: A randomized controlled trial.

OBJECTIVE: Sudden cardiac arrest caused by cardiac arrhythmias is 1 of the leading causes of death worldwide. Implantable cardioverter defibrillators (ICDs) are considered as standard care for patients with increased risk of arrhythmias. However, 1 in 4 ICD patients experiences psychological distress post-ICD implantation. The WEB-based distress management program for ICD patients (WEBCARE) was developed to mitigate anxiety and depression and enhance health-related quality of life in ICD patients. This study investigates the 6- and 12-months outcomes. METHOD: A total of 289 consecutive ICD patients from 6 referral hospitals in the Netherlands were randomized to either the WEBCARE (n = 146) or usual care (n = 143) group. Patients in the WEBCARE group received an online, 12-weeks fixed, 6 lesson behavioral treatment based on problem solving therapy. Patients in the usual care group receive care as usual. RESULTS: Current findings show no significant difference on anxiety, depression or quality of life between the WEBCARE and Usual Care group at 6- and 12-months postimplantation. CONCLUSIONS: In this clinical trial of a Web-based behavioral intervention for ICD patients, the Web-based treatment was not superior to usual care on the long-term regarding patient reported outcomes. Future studies are warranted to examine the applicability of blended-care models and focus on further personalizing the program in order to increase adherence and improve outcomes. (PsycINFO Database Record

E-health to manage distress in patients with an implantable cardioverter-defibrillator: primary results of the WEBCARE trial.

UNLABELLED: The Web-based distress management program for patients with an implantable cardioverter-defibrillator (ICD; WEBCARE) was developed to mitigate distress and enhance health-related quality of life in ICD patients. This study investigated the treatment effectiveness at 3-month follow-up for generic and disease-specific outcome measures. METHODS: Consecutive patients implanted with a first-time ICD from six hospitals in the Netherlands were randomized to either the "WEBCARE" or the "usual care" group. Patients in the WEBCARE group received a 12-week fixed, six-lesson behavioral treatment based on the problem-solving principles of cognitive behavioral therapy. RESULTS: Two hundred eighty-nine patients (85% response rate) were randomized. The prevalence of anxiety and depression ranged between 11% and 30% and 13% and 21%, respectively. No significant intervention effects were observed for anxiety (ß = 0.35; p = .32), depression (ß = -0.01; p = .98) or health-related quality of life (Mental Component Scale: ß = 0.19; p = .86; Physical Component Scale: ß = 0.58; p = .60) at 3 months, with effect sizes (Cohen d) being small (range, 0.06-0.13). There were also no significant group differences as measured with the disease-specific measures device acceptance (ß = -0.37; p = .82), shock anxiety (ß = 0.21; p = .70), and ICD-related concerns (ß = -0.08; p = .90). No differences between treatment completers and noncompleters were observed on any of the measures. CONCLUSIONS: In this Web-based intervention trial, no significant intervention effects on anxiety, depression, health-related quality of life, device acceptance, shock anxiety, or ICD-related concerns were observed. A more patient tailored approach targeting the needs of different subsets of ICD patients may be warranted. TRIAL REGISTRATION: clinicaltrials.gov. Identifier: NCT00895700.

Trajectories of perceived emotional and physical distress in patients with an implantable cardioverter defibrillator.

BACKGROUND: Little is known about the course of emotional and physical distress in patients with an implantable cardioverter defibrillator (ICD). PURPOSE: We examined (1) trajectories of emotional and physical distress in the first 18 months postimplantation and (2) predictors of these trajectories, including demographical, clinical, and personality factors. METHODS: Dutch patients with an ICD (N = 645) completed measures on anxiety, depression, somatic symptoms, and perceived disability at the time of implantation, and 2, 12, and 18 months postimplantation. Measures on Type D personality (tendency to inhibit the expression of negative emotions) and anxiety sensitivity (tendency to fear anxiety-related sensations) were also completed at baseline. RESULTS: Latent class analysis (LatentGOLD) identified six to seven distinct trajectories, varying largely in overall levels of distress, and remaining relatively stable after a small initial decline. Multinomial regression showed that Type D personality and anxiety sensitivity were the most prominent predictors, particularly of trajectories that reflected higher distress levels. Cardiac resynchronization therapy and coronary artery disease also increased the risk for distress, whereas ICD indication and shocks did not. CONCLUSIONS: The course of emotional and physical distress may be relatively stable after ICD implantation. In clinical practice, identification of patients with high risk of higher levels of emotional and physical distress may be warranted; as such, patients with high levels of anxiety sensitivity or a Type D personality should be identified and offered behavioral support.

Age-related differences in the effect of psychological distress on mortality: Type D personality in younger versus older patients with cardiac arrhythmias.

BACKGROUND: Mixed findings in biobehavioral research on heart disease may partly be attributed to age-related differences in the prognostic value of psychological distress. This study sought to test the hypothesis that Type D (distressed) personality contributes to an increased mortality risk following implantable cardioverter defibrillator (ICD) treatment in younger patients but not in older patients. METHODS: The Type D Scale (DS14) was used to assess general psychological distress in 455 younger (≤70 y, m = 59.1) and 134 older (>70 y, m = 74.3) ICD patients. End points were all-cause mortality and cardiac death after a median follow-up of 3.2 years. RESULTS: Older patients had more advanced heart failure and a higher mortality rate (n = 34/25%) than younger patients (n = 60/13%), P = 0.001. Cardiac resynchronization therapy (CRT), but not Type D personality, was associated with increased mortality in older patients. Among younger patients, however, Type D personality was associated with an adjusted hazard ratio = 1.91 (95% CI 1.09-3.34) and 2.26 (95% CI 1.16-4.41) for all-cause and cardiac mortality; other predictors were increasing age, CRT, appropriate shocks, ACE-inhibitors, and smoking. CONCLUSION: Type D personality was independently associated with all-cause and cardiac mortality in younger ICD patients but not in older patients. Cardiovascular research needs to further explore age-related differences in psychosocial risk.

New image processing and noise reduction technology allows reduction of radiation exposure in complex electrophysiologic interventions while maintaining optimal image quality: a randomized clinical trial.

BACKGROUND: Despite their carcinogenic potential, X-rays remain indispensable for electrophysiologic (EP) procedures. OBJECTIVE: The purpose of this study was to evaluate the dose reduction and image quality of a novel X-ray technology using advanced image processing and dose reduction technology in an EP laboratory. METHODS: In this single-center, randomized, unblinded, parallel controlled trial, consecutive patients undergoing catheter ablation for complex arrhythmias were eligible. The Philips Allura FD20 system allows switching between the reference (Allura Xper) and the novel X-ray imaging technology (Allura Clarity). Primary end-point was overall procedural patient dose, expressed in dose area product (DAP) and air kerma (AK). Operator dose, procedural success, and necessity to switch to higher dose settings were secondary end-points. RESULTS: A total of 136 patients were randomly assigned to the novel imaging group (n = 68) or the reference group (n = 68). Baseline characteristics were similar, except patients in the novel imaging group were younger (58 vs 65 years, P < .01). Median DAP and AK were 43% and 40% lower in the novel imaging group, respectively (P < .0001). A 50% operator dose reduction was achieved in the novel imaging group (P < .001). Fluoroscopy time, number of exposure frames, and procedure duration were equivalent between the two groups, indicating that the image quality was similarly adequate in both groups. Procedural success was achieved in 91% of patients in both groups; one pericardial tamponade occurred in the novel imaging group. CONCLUSION: The novel imaging technology, Allura Clarity, significantly reduces patient and operator dose in complex EP procedures while maintaining image quality.

[Catheter ablation in patients with atrial fibrillation: what will change in daily practice?]. / Katheterablatie bij patiënten met boezemfibrilleren: wat verandert er voor de dagelijkse praktijk?

A recent publication compared catheter ablation and antiarrhythmic drugs as initial therapy for paroxysmal atrial fibrillation. No difference was seen in the primary endpoint of the cumulative AF burden over two years. The burden of AF was documented objectively by a series of 7-day continuous ECG recordings; a method that will evolve as a gold standard for measuring the AF burden. The major shortcoming of the study was an obsolete ablation endpoint, lacking verification of pulmonary vein isolation. Other drawbacks were the fact that ablations were not exclusively carried out in high-volume centres and a high cross-over rate in the drug group. Also, although the primary endpoint was not significantly different, several secondary outcomes obviously favoured ablation. Outcomes in both the ablation and drug groups were relatively good, and this study will not change the current practice for the majority of paroxysmal AF patients, although catheter ablation could be performed as the initial therapy.

Prognostic importance of distressed (Type D) personality and shocks in patients with an implantable cardioverter defibrillator.

BACKGROUND: Clinical trials have shown the benefit of implantable cardioverter defibrillator (ICD) treatment. In this study, we examined the importance of chronic psychological distress and device shocks among ICD patients seen in clinical practice. METHODS: This prospective follow-up study included 589 patients with an ICD (mean age=62.6 ± 10.1 years; 81% men). At baseline, vulnerability for chronic psychological distress was measured by the 14-item Type D (distressed) personality scale. Cox regression models of all-cause and cardiac death were used to examine the importance of risk markers. RESULTS: After a median follow-up of 3.2 years, 94 patients (16%) had died (67 cardiac death), 61 patients (10%) had experienced an appropriate shock and 28 (5%) an inappropriate shock. Inappropriate shocks were not associated with all-cause (p=0.52) or cardiac (p=0.99) death. However, appropriate shocks (HR=2.60, 95% CI 1.47-5.58, p=0.001) and Type D personality (HR=1.85, 95% CI 1.12-3.05, p=0.015) were independent predictors of all-cause mortality, adjusting for age, sex, left ventricular ejection fraction, cardiac resynchronization therapy (CRT), secondary indication, history of coronary artery disease, medication and diabetes. Type D personality and appropriate shocks also independently predicted an increased risk of cardiac death. Other independent predictors of poor prognosis were older age, treatment with CRT and diabetes. CONCLUSION: Vulnerability to chronic psychological distress, as defined by the Type D construct, had incremental prognostic value above and beyond clinical characteristics and ICD shocks. Physicians should be aware of chronic psychological distress and device shocks as markers of an increased mortality risk in ICD patients seen in daily clinical practice.

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.

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.

Posttraumatic stress 18 months following cardioverter defibrillator implantation: shocks, anxiety, and personality.

OBJECTIVE: Posttraumatic stress disorder (PTSD) has been observed in cardiac patients, but little is known about PTSD in implantable cardioverter defibrillator (ICD) patients. We examined the prevalence and predictors (clinical variables, personality, and anxiety) of PTSD in ICD patients. METHOD: Three hundred ninety-five ICD patients (20.1% female; mean age = 62.8 ± 10.3 years) from two Dutch referral hospitals completed the 14-item Type D scale (DS14) and the State-Trait Anxiety Inventory to assess Type D (distressed) personality (high negative affect with social inhibition) and anxiety (on the State Anxiety Inventory) at the time of implantation. Logistic regression analysis was performed to identify independent predictors of PTSD at 18 months postimplantation. RESULTS: At 18 months postimplantation, 30 patients (7.6%) qualified for a PTSD diagnosis. Of these patients, 55% (n = 16) had a Type D personality, 83% (n = 25) experienced anxiety at baseline, and 24% (n = 7) had experienced shocks during follow-up. Both Type D personality (odds ratio [OR] = 3.5) and baseline anxiety (OR = 4.3) were significant predictors of posttraumatic stress at 18 months postimplantation, independent of shocks and other clinical and demographic covariates. Shocks were not significantly associated with PTSD. CONCLUSION: A significant group of ICD patients is at risk of posttraumatic stress 18 months postimplantation, especially Type D patients and patients with increased levels of baseline anxiety. Identification of patients with Type D personality and anxiety at the time of implantation may be warranted to prevent PTSD in ICD patients.

Gender disparities in anxiety and quality of life in patients with an implantable cardioverter-defibrillator.

AIMS: A paucity of studies in implantable cardioverter-defibrillator (ICD) patients has examined gender disparities in patient-reported outcomes, such as anxiety and quality of life (QoL). We investigated (i) gender disparities in anxiety and QoL and (ii) the magnitude of the effect of gender vs. New York Heart Association (NYHA) functional class (III/IV), ICD shock, and Type D personality on these outcomes. METHODS AND RESULTS: Implantable cardioverter-defibrillator patients (n = 718; 81% men) completed the State-Trait Anxiety Inventory (STAI) and the Short-Form Health Survey 36 (SF-36) at baseline and 12 months post-implantation. The magnitude of the effect was indicated using Cohen's effect size index. Multivariate analysis of covariance for repeated measures showed no differences between men and women on mean scores of anxiety (F((1,696)) = 2.67, P = 0.10). Differences in QoL were observed for only two of the eight subscales of the SF-36, with women reporting poorer physical functioning (F((1,696)) = 7.14, P = 0.008) and vitality (F((1,696)) = 4.88, P = 0.028) than men. With respect to anxiety, effect sizes at baseline and 12 months for gender, NYHA class, and ICD shocks were small. A large effect size for Type D personality was found at both time points. For QoL, at baseline and 12 months, the effect sizes for gender were small, while the influence of NYHA class and Type D personality was moderate to large. CONCLUSIONS: Men and women did not differ on mean anxiety or QoL scores, except for women reporting poorer QoL on two domains. The relative influence of gender on anxiety and QoL was less than that of NYHA functional class and Type D personality.

Effect of cardiac resynchronization therapy-defibrillator implantation on health status in patients with mild versus moderate symptoms of heart failure.

Indications for cardiac resynchronization therapy (CRT) have expanded to include patients with mild congestive heart failure (CHF) symptoms (New York Heart Association [NYHA] functional class II) because of a demonstrated morbidity reduction in this subset of patients. However, little is known about postimplantation changes in their self-reported health status compared to patients with more severe CHF. The aim of this study was to examine the influence of baseline NYHA functional class on health status changes in the first 12 months after implantation of a CRT with defibrillator (CRT-D). Patients with first-time CRT-D (n = 169, 75% men, mean age 62.1 ± 10.7 years) were recruited from 3 Dutch hospitals. All patients completed the SF-36 Health Survey at the time of implantation and at 12 months after implantation. Mildly (NYHA functional class II; n = 54) and moderately (NYHA functional class III; n = 115) symptomatic CHF patients showed improved health status in several SF-36 domains at 12 months after CRT-D. When adjusting for baseline health status, the groups did not differ with respect to their health status improvement over time, but after adjustment for demographic and clinical factors, the mildly symptomatic patients reported relatively more improvement in general health (B = 10.15, SE = 3.31, p = 0.003) and social functioning (B = 10.64, SE = 3.74, p = 0.005). In conclusion, NYHA functional class II patients reported equal, and in some domains even more, improvement in health status compared to NYHA functional class III patients at 12 months after CRT-D. Hence, CRT not only prevents clinical adverse events in patients with mild CHF symptoms but also improves health status.

Three-dimensional CT overlay in comparison to CartoMerge for pulmonary vein antrum isolation.

INTRODUCTION: Three-dimensional (3D) navigation systems are widely used for pulmonary vein antrum isolation (PVAI). To circumvent left atrial (LA) mapping, 3D CT reconstructions of the LA can be superimposed directly (CT overlay) on the fluoroscopy image to guide ablation catheters and to mark ablation sites. METHODS AND RESULTS: Sixty-eight patients (pts) with symptomatic AF refractory to medical therapy were randomly assigned to CT overlay (group 1, n = 38) or CartoMerge (group 2, n = 30). In group 1 registration of the CT image was performed with contrast injections in 2 orthogonal projections. In group 2, visualization of all pulmonary vein (PV) ostia was done by PV angiography, followed by merging of the CT image and the Carto shell. We compared procedural success, procedure time, fluoroscopy time and radiation burden, measured as dose area product (DAP). Baseline characteristics were comparable in both groups. Procedural success, defined as disappearance of PV potentials in all PVs, was achieved in 37/38 (97%) of group 1 patients and 27/30 (90%) patients in group 2 (P = NS). Total procedure time was significantly shorter in group 1 compared to group 2 (129 +/- 34 vs 181 +/- 30 min, P < 0.0001). Although fluoroscopy time tended to be longer in the CT overlay group (47 +/- 16 vs 40 +/- 13 min, P = 0.06), proper use of diaphragmation resulted in comparable radiation values for both groups (DAP 53 +/- 27 vs 56 +/- 35 Gy cm(2), P = 0.76). CONCLUSIONS: CT overlay for PV isolation is feasible and may, in comparison to conventional LA navigation systems, shorten procedural time without increases in radiation burden.