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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

Volumetric Response beyond Six Months of Cardiac Resynchronization Therapy and Clinical Outcome.

AIMS: Response to cardiac resynchronization therapy (CRT) is often assessed six months after implantation. Our objective was to assess the number of patients changing from responder to non-responder between six and 14 months, so-called late non-responders, and compare them to patients who were responder both at six and 14 months, so-called stable responders. Furthermore, we assessed predictive values of six and 14-month response concerning clinical outcome. METHODS: 105 patients eligible for CRT were enrolled. Clinical, laboratory, ECG, and echocardiographic parameters and patient-reported health status (Kansas City Cardiomyopathy Questionnaire [KCCQ]) were assessed before, and six and 14 months after implantation. Response was defined as ≥15% LVESV decrease as compared to baseline. Major adverse cardiac events (MACE) were registered until 24 months after implantation. Predictive values of six and 14-month response for MACE were examined. RESULTS: In total, 75 (71%) patients were six-month responders of which 12 (16%) patients became late non-responder. At baseline, late non-responders more often had ischemic cardiomyopathy and atrial fibrillation, higher BNP and less dyssynchrony compared to stable responders. At six months, late non-responders showed significantly less LVESV decrease, and higher creatinine levels. Mean KCCQ scores of late non-responders were lower than those of stable responders at every time point, with the difference being significant at 14 months. The 14 months response was a better predictor of MACE than six months response. CONCLUSIONS: The assessment of treatment outcomes after six months of CRT could be premature and response rates beyond might better correlate to long-term clinical outcome.

Trajectories of patient-reported health status in patients with an implantable cardioverter defibrillator.

To date, no study has assessed the course of patient-reported health status in patients with an implantable cardioverter defibrillator (ICD). Studying health status trajectories and their baseline determinants would permit the identification of patients at risk for poor health outcomes after ICD implantation. A combined cohort of 1,222 patients with an ICD (79% men; age = 61.4 [11.2] years) completed the 12-Item Short-Form Health Survey at baseline and 2 to 3 months and 12 to 14 months after implantation. Latent class analyses were used to identify trajectories and predictors of health status over time. Most health status trajectories showed a stable pattern after short-term follow-up, with differences between trajectories being mainly related to differences in absolute levels of health status. Seven trajectories were identified for physical health status. Being unemployed, symptomatic heart failure, ICD shock, psychotropic medication, negative affectivity, and type D personality were identified as independent determinants of poorer physical health status. For mental health status, 6 trajectories were identified. Younger age, low educational level, symptomatic heart failure, renal failure, no use of ACE inhibitors, psychotropic medication, negative affectivity, and type D personality were identified as independent determinants of poorer mental health status. In conclusion, the population with an ICD seems to be heterogeneous in terms of patient-reported physical and mental health status. Patients with an ICD who present with poor health status and a distressed personality profile should be timely identified and monitored as they may benefit from cardiac rehabilitation in combination with behavioral intervention.

Persistent and fluctuating anxiety levels in the 18 months following acute myocardial infarction: the role of personality.

OBJECTIVE: To identify the varying courses of anxiety symptoms in the first 18 months after a myocardial infarction (MI) and to examine the importance of personality in determining elevated anxiety. METHODS: Four hundred eighty-six MI patients completed the State-Trait Anxiety Inventory during hospitalization and at 2-, 12- and 18-months post-MI. At baseline, patients also completed the DS14 Type D personality scale, Anxiety Sensitivity Index and Beck Depression Inventory, and clinical and sociodemographic information was collected. RESULTS: Growth mixture modeling analysis identified four anxiety trajectories. The majority of patients reported stable anxiety scores over time, indicative of either persistent high (17%) or low (71%) anxiety. Patients in the other two smaller groups initially reported moderate levels of anxiety that fluctuated during follow-up. Type D personality [odds ratio (OR)=5.34; 95% confidence interval (CI): 2.26-12.63], negative affectivity (OR=3.24; 95% CI: 1.29-8.14) and anxiety sensitivity (OR=3.35; 95% CI: 1.69-6.62) were the most prominent determinants of persistent high anxiety, independent of depression, sociodemographic and clinical factors. CONCLUSIONS: The course of anxiety in the first 18 months after MI is relatively stable for the majority of patients. Patients with Type D personality, negative affectivity and anxiety sensitivity are at an increased risk for persisting elevated anxiety and should be identified and offered appropriate treatment.

Temporary balloon occlusion of the internal iliac arteries to prevent massive hemorrhage during cesarean delivery among patients with placenta previa.

OBJECTIVE: To evaluate the effectiveness of temporary balloon occlusion of the internal iliac artery before uterine incision to prevent massive obstetric hemorrhage during cesarean delivery among patients with anterior placenta previa. METHODS: In a retrospective cohort study conducted at Amphia Hospital Breda (Breda, Netherlands), data were analyzed from women with anterior placenta previa who delivered by cesarean between January 1, 2001, and September 30, 2012. Cases with and without balloon occlusion of the internal iliac artery were included. The primary outcomes were the amount of blood loss during cesarean delivery, drop of hemoglobin level, and blood loss of more than 1000 mL. RESULTS: Of 68 eligible women, 42 (62%) had temporary balloon occlusion and 26 (38%) had no balloon occlusion. Median blood loss was 800 mL (interquartile range [IQR] 488-1113) in the balloon group and 1000 mL (IQR 694-1307) in the no balloon group (P=0.06). Blood loss of 1000 mL or more was recorded in 16 (38%) women in the balloon group and 18 (69%) in the no balloon group (P=0.01). CONCLUSION: Temporary balloon occlusion of the internal iliac artery before uterine incision during cesarean delivery could potentially reduce blood loss among patients with anterior placenta previa. Large, randomized controlled trials are needed to confirm the results.

Cardiac patients who completed a longitudinal psychosocial study had a different clinical and psychosocial baseline profile than patients who dropped out prematurely.

Non-response is a serious threat to the external validity of longitudinal psychosocial studies. Little is known about potential systematic differences between patients with coronary artery disease who complete a psychosocial study and those who drop out prematurely due to non-response, or whether drop-outs may have a different cardiovascular risk. We studied a cohort of 1132 consecutive patients undergoing percutaneous coronary intervention (PCI). At baseline, all patients completed the Hospital Anxiety and Depression Scale (HADS) and the Type D Scale (DS14). At 12 months follow-up, 70.8% (n = 802) of patients completed both questionnaires, while 29.2% (n = 330) dropped out. We observed significant differences in socio-demographic, clinical, and psychological baseline characteristics between completers and drop-outs. Drop-outs were younger, more likely to smoke, but less often prescribed cardiovascular medications, including calcium antagonists and angiotensin-converting enzyme inhibitors, as compared with completers. Drop-outs more often had depression, anxiety, and negative affectivity, as compared with completers (all p-values <0.05). After a median follow-up of 4 years, we found no significant differences in mortality risk between completers and drop-outs (6.5 vs. 7.3%; adjusted HR 1.34, 95% CI 0.82-2.19, respectively). In conclusion, a possible attrition bias occurred, as drop-outs and completers differed systematically on some socio-demographic, clinical, and psychological baseline characteristics. Despite these differences, this did not translate into a poorer short-term prognosis, as there were no differences in the mortality risk of completers vs. drop-outs after a median follow-up of 4 years. In future prospective studies, attention should be paid to attrition bias, and its possible impact on study results and implications should be discussed.

Self-reported health-related quality of life predicts 5-year mortality and hospital readmissions in patients with ischaemic heart disease.

BACKGROUND: Patient health-related quality of life (HRQL) is an important health outcome with lower HRQL associated with adverse events in patients with ischaemic heart disease (IHD). DESIGN: Baseline health-related quality of life was investigated as a predictor of 5-year all-cause mortality and cardiac readmissions in Danish patients with IHD. METHODS: The international HeartQoL Project survey was designed to develop a core HRQL questionnaire for patients with IHD. Baseline scores on each of the 14 items ultimately included in the HeartQoL questionnaire were linked to Danish national health registries and hazard ratios for mortality and readmissions were estimated using Cox regression models. RESULTS: Among 938 eligible Danish patients with IHD, 662 (70.6%) participated in the international HeartQoL Project. During the 5-year follow-up, 83 patients died and 196 patients were readmitted. Adjusted analyses showed a significant linear association between all-cause mortality and both lower global HRQL (HR = 1.67, 95% CI: 1.26-2.23; p<0.001) and physical scores (HR=1.71, 1.33-2.21; p<0.001) and between readmission and both lower global (HR=1.73, 1.41-2.12; p < 0.001) and physical scores (HR = 1.63, 1.35-1.96; p < 0.001). A significant, but non-linear, effect was found for emotional HRQL score on outcomes. CONCLUSION: This study shows a significant and linear relationship between lower global and physical HRQL scores in patients with IHD and 5-year all-cause mortality and cardiac readmission.

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.