Implantable cardioverter defibrillators and quality of life: results from the defibrillators in nonischemic cardiomyopathy treatment evaluation study

BACKGROUND: The Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation study demonstrated that implantable cardioverter defibrillators (ICDs) significantly reduce the risk of sudden cardiac death in patients with nonischemic cardiomyopathy and an ejection fraction of 35% or less, with no statistically significant decrease in overall mortality. The impact of ICD placement and shock on health-related quality of life (HRQL) in this population is unknown. METHODS: The 12-Item Medical Outcomes Short-Form Health Survey and the Minnesota Living with Heart Failure Questionnaire were administered to 458 patients with nonischemic cardiomyopathy, an ejection fraction of 35% or less, and either nonsustained ventricular tachycardia or 10 or more premature ventricular depolarizations per hour at baseline, 1 month after randomization, and every 3 months thereafter throughout the trial. The subjects were randomized to an ICD or standard medical therapy. Outcomes were compared using hierarchical linear regression. RESULTS: Overall, there were no significant differences in HRQL throughout the trial between patients randomized to an ICD or standard medical therapy. However, in patients with 1 or more ICD shocks, HRQL declined 0.5 +/- 0.2 (mean +/- SD) points per shock on the emotional scale of the Minnesota Living with Heart Failure Questionnaire (P = .04) and 1.0 +/- 0.5 points per shock on the mental component score of the 12-Item Medical Outcomes Short-Form Health Survey (P = .04). CONCLUSIONS: Overall, HRQL was not affected by ICD implantation in patients in the Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation study. Implantable cardioverter defibrillator shock was associated with a reduction in some measures of HRQL, but the effects were unlikely to result in a clinically observable alteration until 5 or more shocks were experienced.     

植入型心律转复除颤器在心脏性猝死一级和二级预防中的应用

目的比较植入型心律转复除颤器（ICD）在心脏性猝死一级及二级预防中的治疗作用。方法对2005年1月至2009年6月符合ICD一级预防及二级预防标准并在我院植入ICD的患者进行随访。ICD的诊断设置室性心动过速（VT）、快速室性心动过速（FVT）及心室颤动（VF）3个工作区,治疗设置抗心动过速起搏（ATP）、低能量同步转复（CV）和高能量除颤（DF）。术后每3—6个月随访1次,利用程控仪获取ICD储存资料,了解患者心律失常发作情况以及ICD的诊断和治疗情况。结果共随访了40例患者,一级预防及二级预防各20例,平均随访时间一级预防组（12．2±7．6）个月,二级预防组（14．6±9．6）个月。随访过程中共13例患者发生了VF事件,其中一级预防组4例,二级预防组9例,21例患者发生了VT事件,其中一级预防组9例,二级预防组12例,统计学分析显示两组患者间VF及VT事件发生率差异无统计学意义。VT发生频率（VTfrenquency）在一级预防组为4．465次／月,二级预防组为26．16次／月（P〈0．001）。VT发作时间（VTduration）在一级预防组为（25．6±15．6）s,二级预防组为（78．1±58．7）s（P〈0．001）。一级预防组中9例患者ICD记录有持久性VT事件,其中由ATP终止6例,CV终止3例。4例患者有VF事件,均DF成功,二级预防组中12例患者ICD记录有持久性VT事件,其中由ATP终止7例,CV终止5例。9例患者有VF事件,均DF成功。结论二级预防的患者室性心律失常发作频率及发作时间均明显高于一级预防的患者,但因样本量较小,两组患者间因VT或VF接受ICD治疗的比例差异无统计学意义。     

Initial experience with an implantable cardioverter-defibrillator incorporating cardiac resynchronization therapy

OBJECTIVES: The purpose of this study was to evaluate an implantable cardioverter-defibrillator (ICD) incorporating biventricular pacing. BACKGROUND: Biventricular pacing improves the symptoms of heart failure, a frequent problem in ICD recipients. METHODS: This prospective multicenter study evaluated the safety and efficacy of an ICD with biventricular pacing. RESULTS: A total of 84 patients with a standard ICD indication, symptomatic heart failure, left ventricular (LV) ejection fraction <35% and a QRS duration >130 ms were included in the trial. In 81 of 84 patients the LV lead was successfully implanted. Patients significantly improved in the 6-min hall-walk test (baseline 304 plus minus 131 m, three months 397 plus minus 142 m, p < 0.001), quality of life (baseline 38.9 plus minus 21.2, three months 26.5 plus minus 21.2, p < 0.001) and the New York Heart Association (NYHA) classification (baseline 2.8 plus minus 0.6, three months 2.2 plus minus 0.5). Left ventricular end-diastolic (from 79.6 plus minus 13.0 mm to 73.6 plus minus 12.9 mm, p = 0.002) and end-systolic (from 68.3 plus minus 13.5 mm to 63.9 plus minus 12.9 mm, p < 0.001) diameter decreased, and fractional shortening increased (from 16 plus minus 6% to 18 plus minus 6%, p = 0.018). Of the patients 26 experienced 472 episodes of spontaneous sustained ventricular tachyarrhythmias. All episodes were successfully terminated except for 16 episodes occurring in a patient with incessant ventricular tachycardia. Biventricular antitachycardia pacing was more effective than right ventricular antitachycardia pacing (p < 0.001). During follow-up (median 185 days, range 12 to 344 days) five patients died from progressive heart failure. CONCLUSIONS: Incorporating biventricular pacing in an ICD is feasible and leads to an improvement of heart failure symptoms. Therefore, this therapy may become an option for patients who need ICD therapy in the presence of severe heart failure.     

QT Variability during Rest and Exercise in Patients with Implantable Cardioverter Defibrillators and Healthy Controls

Background: Increased QT Variability (QTVI) is predictive of life threatening arrhythmias in vulnerable patients. The predictive value of QTVI is based on resting ECGs, and little is known about the effect of acute exercise on QTVI. The relation between QTVI and arrhythmic vulnerability markers such as T‐wave alternans (TWA) has also not been studied. This study examined the effects of exercise on QTVI and TWA in patients with arrhythmic vulnerability. Methods: Digitized ECGs were obtained from 47 ICD patients (43 males; age 60.9 ± 10.1) and 23 healthy controls (18 males; age 59.7 ± 9.5) during rest and bicycle exercise. QTVI was assessed using a previously validated algorithm and TWA was measured as both a continuous and a categorical variable based on a priori diagnostic criteria. Results: QTVI increased with exercise in ICD patients (?0.79 ± 0.11 to 0.36 ± 0.08, P < 0.001) and controls (?1.50 ± 0.07 to ?0.19 ± 0.12, P < 0.001), and QTVI levels were consistently higher in ICD patients than controls during rest and exercise (P < 0.001). The magnitude of QTVI increase from baseline levels was not larger among ICD patients versus controls (P > 0.20). Among ICD patients, elevated exercise QTVI was related to lower LV ejection fraction and inducibility of ischemia (P < 0.05). QTVI at rest correlated with exercise TWA (r = 0.54, P = 0.0004). Conclusions: QT variability increases significantly with exercise, and exercise QTVI is related to other well‐documented markers of arrhythmic vulnerability, including low ejection fraction, inducible ischemia, and TWA. Resting QTVI may be useful in the risk stratification of individuals incapable of performing standard exercise protocols.     

The relationship between health-related quality of life, lung function and daily symptoms in patients with persistent asthma

It is generally believed that there is a direct correlation between asthma control and a patient's health-related quality of life (HRQL). Objective and subjective measures of asthma control are used interchangeably. A retrospective analysis from 8994 patients from 27 randomized, controlled clinical trials with persistent asthma was conducted to determine the degree of association which exists between objective (lung function) and subjective (symptoms, quality of life) measures. Assessments were made via forced expiratory volume in 1-second (FEV1), self-reported symptoms and the Asthma Quality of Life Questionnaire (AQLQ) overall scores. Baseline percent predicted FEV1 was weakly correlated with baseline symptom-free days (SFD) and baseline overall AQLQ scores (r=0.11 and 0.09, respectively; P <0.001). Changes in percent predicted FEV1 correlated weakly with changes in SFD but was more strongly correlated with changes in overall AQLQ scores (r= 0.26 and 0.38, respectively; P <0.001). Additionally, SFD at both baseline and endpoint were moderately correlated with overall AQLQ scores at baseline and endpoint (r=0.36 and 0.44; P <0.001). This study suggests that the impact of asthma on a patients' HRQL is not fully accounted for by objective measures such as lung function. Thus, HRQL data complements rather than duplicates results from traditional, objective assessments of asthma control.     

Clustering of ventricular tachyarrhythmias in heart failure patients implanted with a biventricular cardioverter defibrillator

Background: Temporal patterns of ventricular tachyarrhythmia (VT/VF) have been studied only in patients who have received implantable cardioverter defibrillators (ICD) for secondary prevention of sudden death, and mainly in ischemic patients. The aim of this study was to evaluate VT/VF recurrence patterns in heart failure (HF) patients with biventricular ICD and to stratify results according to HF etiology and ICD indication.
Methods and Results: We studied 421 patients (91% male, 66 ± 9 years). HF etiology was ischemic in 292 patients and nonischemic in 129. ICD indication was for primary prevention in 227 patients and secondary prevention in 194. Baseline left ventricular ejection fraction (LVEF) was 26 ± 7%, QRS duration 168 ± 32 msec, and NYHA class 2.9 ± 0.6. In a follow-up of 19 ± 11 months, 1,838 VT/VF in 110 patients were appropriately detected. In 59 patients who had ≥4 episodes, we tried to determine whether VT/VF occurred randomly or rather tended to cluster by fitting the frequency distribution of tachycardia interdetection intervals with exponential functions: VT/VF clusters were observed in 46 patients (78% of the subgroup of patients with ≥4 episodes and 11% of the overall population). On multivariate logistic analysis, VT/VF clusters were significantly (P < 0.01) associated with ICD indication for secondary prevention (odds ratio [OR]= 3.12; confidence interval [CI]= 1.56–6.92), nonischemic HF etiology (OR = 4.34; CI = 2.02–9.32), monomorphic VT (OR = 4.96; CI = 2.28–10.8), and LVEF < 25% (OR = 3.34; CI = 1.54–7.23). Cardiovascular hospitalizations and deaths occurred more frequently in cluster (21/46 [46%]) than in noncluster patients (63/375 (17%), P < 0.0001).
Conclusions: In HF patients with biventricular ICDs, VT/VF clusters may be regarded as the epiphenomenon of HF deterioration or as a marker of suboptimal response to cardiac resynchronization therapy.     

Physical functioning and mental well-being in association with health outcome in patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial II.

AIMS: The association of psychosocial and physical factors with health outcome in patients with congestive heart failure (CHF) has not been fully explored. The aim of this study was to assess the physical and mental health in relationship to health outcome in post-infarction patients with advanced left ventricular dysfunction. METHODS AND RESULTS: A total of 1058 patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) completed the Medical Outcome Trust Short Form (SF-12) at baseline. Physical component summary (PCS) and mental component summary (MCS) of SF-12 were analysed in relationship to survival, hospitalization due to CHF, and implantable cardioverter-defibrillator (ICD) therapy. Both baseline PCS and MCS were significantly associated with death (P < 0.001 and P < 0.016, respectively) and hospitalization due to CHF (P 相似文献   

Optimal Timing of Implantable Cardioverter‐Defibrillator Implantation After Myocardial Infarction: A Decision Analysis

ICD Implant Timing . Background: The optimal timing of implantable cardioverter defibrillator (ICD) placement for the primary prevention of sudden cardiac death after myocardial infarction (MI) remains unknown. Methods and Results: We developed a Markov model to investigate the optimal timing of ICD implantation after MI (no ICD, ICD at 60 days, 6 months, and 1 year) in patients who meet current guidelines. Estimates of arrhythmic death (baseline risk 6%, range 1–20% per year), nonarrhythmic death, and ICD efficacy were based upon MADIT‐II and other contemporary post‐MI clinical trials. We used both deterministic and stochastic modeling processes in our analysis. After 10 years follow‐up, the baseline probability of survival was higher in those treated with ICD implantation versus not (42% vs 30%, P < 0.001). Survival was highest with ICD implantation at 60 days versus 6 months versus 1 year: 42.4%, 42.3%, and 42.0% (P = 0.0028). ICD implantation at 60 days provided a mean incremental survival of 0.28 months and 0.84 months per patient (compared with implantation at 6 months and 1 year). In sensitivity analyses, patients’ competing risk for nonarrhythmic death was the primary determinant of benefit from ICD implantation. Overall, ICD implantation at 60 days resulted in the greatest life expectancy over a wide range of plausible nonarrhythmic and arrhythmic death rates. Conclusions: The benefits of early ICD implantation are modest when compared with delayed implantation at 6 months/1 year. Our results suggest that making sure a patient receives an ICD, when appropriate, may be more important than the timing of the implantation procedure. (J Cardiovasc Electrophysiol, Vol. pp. 791‐798, July 2010)     

External cardioversion of atrial fibrillation in patients with implanted pacemaker or cardioverter-defibrillator systems: a randomized comparison of monophasic and biphasic shock energy application.

AIMS: External cardioversion (ECV) of atrial fibrillation (AF) may damage implanted pacemaker and cardioverter-defibrillator (ICD) systems. This prospective study evaluated the safety and efficacy of ECV comparing mono- to biphasic shock waveforms in patients with implanted rhythm devices. METHODS AND RESULTS: Patients with pacemaker or ICD systems and an indication for ECV were randomized to receive mono- or biphasic shocks. Systems were tested immediately before and after ECV, 1 h and 1 week later with respect to device and lead integrity. Forty-four patients (71 +/- 10 years, 31 male; 29 pacemakers, 12 ICDs, three cardiac resynchronization systems) underwent ECV with antero-posterior paddle orientation (monophasic in 21 and biphasic in 23 patients). Pacing impedances were reduced immediately after ECV (atrial 402-392 ohm, P < 0.001; ventricular 517-496 ohm, P = 0.001) and returned to baseline values within 1 week. Ventricular sensing was reduced immediately after ECV (12.4-11.6 mV, P = 0.004). There was no device or lead dysfunction in any patient. ECV was successful in 42/44 patients (95%), cumulative energy was significantly lower for biphasic compared with monophasic shocks (P = 0.001). CONCLUSION: ECV for AF seems to be safe and effective in patients with implanted rhythm devices.     

Outcome in patients with an ICD incorporating cardiac resynchronisation therapy: differences between primary and secondary prophylaxis

BACKGROUND: The incidence of ventricular tachyarrhythmias in ICD patients with cardiac resynchronisation therapy (CRT-D) is not well studied. AIM: To analyse event free survival in CRT-D patients with a primary or a secondary prophylactic ICD indication. METHODS: Prospective, single centre. Eighty-six patients, 44% with a primary prophylactic indication. Actuarial event-free rates for mortality and arrhythmias were calculated. RESULTS: Baseline clinical characteristics were not significantly different between primary and secondary prophylaxis. Primary prophylaxis patients were more likely to be in NYHA class III. Over 21 months, 724 ventricular events with therapy occurred in 36 patients (42%). The actuarial event-free rates, at 1 and 3 years, from appropriate ICD therapy were higher (P<0.001) for primary (79.0% and 67.8%) than for secondary prophylaxis (45.6% and 27.0%). Appropriate ICD therapy occurred more in NYHA class II compared to class III (P=0.016). Underlying disease (ischemic versus non-ischemic) and functional class did not play a role in multivariate analysis. CONCLUSION: Important arrhythmic events in patients with heart failure, and CRT-D occur at a very high rate when the indication is secondary prophylaxis. Patients with primary prophylaxis have an annual event rate of 10%, even though they tend to have a worse heart failure class.     

Improved survival in patients with nonischemic advanced heart failure and syncope treated with an implantable cardioverter-defibrillator

The purpose of this study was to assess whether in patients with syncope and heart failure due to nonischemic cardiomyopathy, treatment with an implantable cardioverter-defibrillator (ICD) compared with conventional medical therapy is associated with a reduction in sudden death and total mortality. Patients with advanced heart failure who have syncope have been shown to be at high risk for sudden death. Further risk stratification has been difficult in patients with nonischemic cardiomyopathy in whom inducibility on electrophysiologic study is not predictive of future risk. Of 639 consecutive patients with nonischemic cardiomyopathy referred for heart transplantation, 147 patients with history of syncope and no prior history of sustained ventricular tachycardia or cardiac arrest were identified. Outcomes were compared for the 25 patients managed with an ICD and 122 patients managed with conventional medical therapy. There were no differences in the baseline variables in the 2 groups of patients, including age, ejection fraction, and medical treatments for heart failure, but patients receiving an ICD were more likely to have had nonsustained ventricular tachycardia (56% vs. 15%, p = 0.001). During a mean follow-up of 22 months, there were 31 deaths, 18 sudden, in patients treated with conventional therapy, whereas there were 2 deaths, none sudden, in patients treated with an ICD. An appropriate shock occurred in 40% of the ICD patients. Actuarial survival at 2 years was 84.9% with ICD therapy and 66.9% with conventional therapy (p = 0.04). Thus, in patients with nonischemic cardiomyopathy and syncope, therapy with an ICD is associated with a reduction in sudden death and an improvement in overall survival.     

Age, functional capacity, and health-related quality of life in patients with heart failure

BACKGROUND: Although heart failure disproportionately affects older persons and is associated with significant physical disability, existing data on physical limitations and health-related quality of life (HRQL) derive largely from studies of younger subjects. We compared the relationship between functional limitation and HRQL between older and younger patients with heart failure. METHODS AND RESULTS: We evaluated 546 outpatients with heart failure enrolled in a multicenter prospective cohort study. At baseline and 6 +/- 2 weeks later, functional status was assessed by New York Heart Association (NYHA) classification and 6-minute walk testing. HRQL was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ). Comparing older (age >65 years, n = 218) and younger patients (n = 328), we assessed baseline HRQL across strata of functional status. In the 484 patients who completed follow-up (194 older and 290 younger patients), we also assessed the changes in HRQL associated with changes in functional status over time. At baseline, older patients had better HRQL than younger patients (mean KCCQ score 60 +/- 25 versus 54 +/- 28, P = .005) in spite of worse NYHA class (mean 2.54 versus 2.35, P < .001) and lower 6-minute walk distances (824 +/- 378 versus 1064 +/- 371 feet, P < .001). After multivariable adjustment including baseline NYHA class, older age was independently correlated with better HRQL (beta = +7.9 points, P < .001). At follow-up, older patients with a deterioration in NYHA class experienced marked declines in HRQL compared with younger patients (mean HRQL change of -14.4 points versus +0.3 points, respectively, P < .001). Analyses using 6-minute walk distance as the functional measure yielded similar results. CONCLUSIONS: Although older patients with heart failure have relatively good HRQL in spite of significant functional limitations, they are at risk for worsening HRQL with further decline in functional status. These results underscore the importance of treatments aimed at maintaining functional status in older persons with heart failure, including those with significant baseline functional limitations.     

Health-related quality of life in a randomised placebo-controlled trial of sibutramine in obese patients with type II diabetes

OBJECTIVE: We evaluated the effects of 12-month treatment with sibutramine 15 mg daily compared with placebo on health-related quality of life (HRQL) in obese type II diabetes patients. We examined the associations between the changes in HRQL and in weight, glycaemic control, and haemodynamic variables. We also explored the predictive value of HRQL and its changes early during treatment. DESIGN: A randomised clinical trial. The subjects were enrolled in a 2-week single-blind run-in period with a modestly hypocaloric diet (700 kcal daily deficit) and then randomised to receive either sibutramine 15 mg (n=114, 60% female) or placebo (n=122, 58% female) once daily with the hypocaloric diet for 12 months. SUBJECTS: Obese (mean BMI 36 kg/m(2) and age 54 y) type II diabetes patients untreated with antidiabetic medications. MEASUREMENTS: The main outcome measures included body weight and HRQL (the RAND 36-Item Health Survey 1.0). RESULTS: The mean weight loss was greater in the sibutramine group (-7.1 kg) than in the placebo group (-2.6 kg, P<0.001). The baseline HRQL was relatively high. There were no significant differences between the treatment groups in glycaemic control or in any of the RAND-36 scales during the study. The scores on physical functioning (PF) and health change (HC) since last year improved in both groups and this improvement was related to weight loss. When HRQL changes were examined in categories of weight loss, the scores on PF and HC increased with >/=5% weight loss, but the scores on vitality (V) and general health (GH) increased only after >/=15% weight loss. Decrease in HbA1c was associated with increases in the scores of PF, GH, V, mental health, and HC. In the sibutramine group, the increase in diastolic blood pressure was associated with the decrease in the scores of PF, physical role functioning, emotional role functioning (ERF), social functioning (SF), and bodily pain. High baseline scores on ERF and SF, and low scores on V predicted weight loss at 12 months. Also, increasing scores on PF and V during the first 3 months predicted weight loss at 12 months. The sum of four dichotomised HRQL variables (baseline ERF >/=75=1 and <75=0; baseline SF>/=80=1 and <80=0; 3-month change in PF>0=1 and 0=1 and /=5% weight loss, but >/=15% weight loss was needed to achieve a cluster of HRQL improvements. The decrease in HbA1c was associated with many HRQL benefits. Poor baseline HRQL and the improvement observed in the first months of treatment may prove to be useful in predicting success in long-term weight loss.     

Factors influencing health-related quality of life in cardiac rehabilitation patients

Associations of age, gender, cardiac procedure (coronary artery bypass grafting or percutaneous transluminal coronary angioplasty), risk stratification, and number of comorbidities with health-related quality of life (HRQL) were examined among 217 men and 84 women (mean age, 63+/-11 years) consecutively enrolled in a phase II cardiac rehabilitation program. Female gender and high-risk stratification were independently associated with impaired treatment gains in most areas of HRQL. Older age and having a greater number of comorbidities were also associated with impaired gains in specific areas. HRQL was generally lower at baseline but not post-treatment in coronary artery bypass grafting vs. percutaneous transluminal coronary angioplasty patients. Cardiac rehabilitation patients also had lower HRQL scores than an age-matched, normative sample at baseline (most areas) and post-treatment (mainly on role physical). Findings reinforce the need for cardiac rehabilitation programs to tailor assessments and risk factor modification strategies to patient characteristics associated with low levels of HRQL, especially in women and those with higher risk stratification.     

Developing a senior healthcare practice using the chronic care model: effect on physical function and health-related quality of life

An ambulatory senior health clinic was developed using the chronic care model (CCM), with emphasis on an interdisciplinary team approach. To determine the effect of this care model approach in a nonprofit healthcare system, an observational, longitudinal panel study of community-dwelling Medicare beneficiaries was performed to examine the effect on physical function and health-related quality of life (HRQL). Participants in the study were recruited from a community sample of 6,864 eligible Medicare beneficiaries. Informed consent and baseline data were obtained from 1,709 individuals (recruitment response rate=25%) and complete data across 30 months from 1,307 (completion response rate=76%). Participants receiving care in the CCM-based senior healthcare practice (n=318) were compared with patients of primary care physicians supported by care managers (n=598) and a group without care managers (n=391). Self-reported data were collected over the telephone to measure physical function and HRQL at baseline and 6, 18, and 30 months. A multiple group mixture growth model was used to analyze physical function and HRQL across the 30 months. Physical function and HRQL mean scores decreased across time in all participants and were moderately correlated at each wave (correlation coefficient=0.74–0.79). Two latent growth classes were identified. In class 1, physical function decreased, and HRQL remained stable across time. In class 2, physical function and HRQL decreased in parallel. Ninety-seven percent of intervention group patients were in class 1, and 99% of patients in comparison groups 1 and 2 were in class 2. Despite physical function decline, patients in a senior health clinic care model maintained HRQL over time, whereas patients receiving traditional care had physical function and HRQL decline. An interdisciplinary team CCM approach appears to have a positive effect on HRQL in this population.     

Reduction of ventricular tachyarrhythmia by treatment of atrial fibrillation in ICD patients with dual-chamber implantable cardioverter/defibrillators capable of atrial therapy delivery: the REVERT-AF Study.

AIMS: The purpose of this prospective, randomized, multicentre study was to investigate whether the incidence of ventricular tachyarrhythmia can be reduced in standard implantable cardioverter/defibrillator (ICD) patients by implanting a dual-chamber ICD capable of atrial therapy delivery. METHODS AND RESULTS: A Jewel AF or GEM III AT ICD (Medtronic Inc., Minneapolis, MN, USA) was implanted in 122 patients (62.3 +/- 10.5 years; 84.4% male; coronary artery disease 71.3%; left ventricular ejection fraction 39.7 +/- 13.6%; secondary ICD indication 91%). Overall, 31.2% of the patients had paroxysmal atrial fibrillation (AF)/atrial tachycardia (AT) before ICD implantation (n = 38). Implantable cardioverter/defibrillator therapies for AT/AF were activated and de-activated every 3 months in a cross-over study design. The mean follow-up was 18.5 +/- 7.7 months (6.29 +/- 2.2 cross-over/patient). Overall, there were 684 episodes of ventricular tachyarrhythmias in 48.4% of patients (n = 59). In 33.6% of patients (n = 41), 532 supraventricular tachyarrhythmias occurred. Activation of ICD therapies for AT/AF did not result in a reduction of ventricular tachyarrhythmias (P = 0.92). Patients with monomorphic ventricular tachycardias (mVTs) as index arrhythmia for ICD implantation or inducible mVTs in the electrophysiological study had the highest probability of recurrences of ventricular tachyarrhythmias. CONCLUSION: For patients with standard indications for ICD therapy and no indication for cardiac pacing, a dual-chamber ICD capable of atrial tachyarrhythmia treatment offers no benefit concerning a reduction of ventricular tachyarrhythmias.     

Do positive health expectations and optimism relate to quality-of-life outcomes for the patient with an implantable cardioverter defibrillator?

PURPOSE: Clinical trials with the implantable cardioverter defibrillator (ICD) have demonstrated desirable outcomes in terms of mortality and morbidity among patients with potentially lethal arrhythmias. This study examined the "resilience factors" of positive health expectations and global optimism prospectively using the general quality-of-life (QOL) scores of newly implanted ICD patients. METHODS: The study enrolled 88 newly implanted ICD patients (mean age, 65.3 +/- 13.2 years; 83% male; 92% white) assessed 8 and 14 months after ICD implantation. A series of 2 x 2 factorial multivariate analyses of covariance were performed to examine the differences between baseline low versus high positive health expectations and baseline low versus high optimism in short- and long-term general QOL scores. RESULTS: After control was used for ejection fraction (mean, 31%), the patients with baseline high positive health expectations reported better general health at a long-term follow-up assessment (P = .002). The patients with high optimism reported better mental health and social functioning at a short-term follow-up assessment (P =. 056), and this finding approached significance at a long-term follow-up assessment (P = .061). CONCLUSIONS: Positive health expectations and optimism are differentially related to various components of QOL. Collectively, these two resilience factors may be targeted in future studies of interventions to improve QOL for ICD patients.     

Linking changes in quality of life to haematologic response and survival in systemic immunoglobulin light-chain amyloidosis

This study reports health-related quality of life (HRQL) among newly-diagnosed immunoglobulin light-chain (AL) patients (n = 914) treated with a bortezomib-based regimen and its association with response depth and survival. Haematologic response/HRQL were assessed over 24 months in an ongoing, prospective study. HRQL change was calculated across haematologic/cardiac response levels. The relationship between baseline HRQL and survival was evaluated by the Cox proportional-hazard model (PH). Shared-random-effects models (SREMs) estimated time-to-death conditional on current HRQL/longitudinal HRQL trajectory. At 3 months, there was consistent decline in 5/8 HRQL domains across all haematologic response levels. By 12 months, 3/5 declining domains improved among complete response (CR) patients. In contrast, the mean change in less-than-CR patients did not indicate improvement. Under the Cox PH, having a baseline HRQL score five points higher than the sample mean was associated with 20% lower mortality risk. SREMs indicated a five-point greater HRQL score at the event time correlated with an approximately 30% decrease in mortality risk. For each one-point increase in HRQL score trajectory slope, mortality risk decreased by approximately 88%. Only CR patients had HRQL improvement, while partial response patients had less decline but no meaningful improvements. These data show the importance of HRQL serial assessments of AL patients and its importance as an end-point.     

Health-related quality of life in patients with coronary artery disease after different treatments for angina in routine clinical practice

BACKGROUND AND AIM: The assessment of health-related quality of life (HRQL) increasingly is an important outcome in the management and care of patients with angina. The aim of this study was to describe the baseline HRQL in patients with coronary artery disease (CAD) and angina and to report the impact of the three established therapeutic strategies, continued medical treatment (CMT), percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) on HRQLover a 12-month follow-up period. PATIENTS AND METHODS: The change in specific HRQL scores and angina severity was evaluated in a routine clinical practice setting in 158 patients with CAD and angina treated either with CMT, PCI, or CABG. The measure used in this study to assess HRQL was the MacNew Heart Disease HROL Questionnaire (MacNew). It was administered before coronary angiography and 12 months after treatment stratification. Angina pectoris was assessed with the modified Canadian Cardiovascular Society's classification. RESULTS: The MacNew discriminated between treatment groups with lowest (poorest HROL) baseline global, physical,and social HRQL scores seen in patients with subsequent CABG. There were significantly greater improvements in global and emotional HRQL scores after both PCI and CABG than after CMT. In all three treatment groups, improved HRQLscores were associated with improved angina grade. CONCLUSION: The present study has shown clearly that evaluating HRQL as an outcome before and after different treatments for angina is feasible and useful in routine clinical practice. Measurement of HRQL discriminated between treatment groups at baseline and was responsive demonstrating improvement with each treatment alternative but most notably with CABG. The improved HROL was consistent with changes in angina severity. The MacNew may be useful when comparing outcomes across different treatments among patients with CAD and angina.