Stroke is one of the leading causes of disability and death worldwide. Prevention of stroke is therefore essential. Effective prevention should be tailored to the clinical characteristics,... Show moreStroke is one of the leading causes of disability and death worldwide. Prevention of stroke is therefore essential. Effective prevention should be tailored to the clinical characteristics, lifestyle, and environment of the individual, among others. This is also known as precision prevention. An important example illustrating the need for precision prevention is the existence of sex differences in stroke occurrence. In practice, for predicting stroke risk, only traditional risk factors (such as smoking and hypertension) are included, and women-specific risk factors are not yet routinely included. As a result, women with an increased risk of stroke may be missed, which also prevents timely initiation of preventive treatments. In this thesis, I tried to lay the foundation for precision prevention of stroke in women.Part I discussed the pathophysiology underlying women-specific risk factors for stroke, and gender differences in the clinical presentation of stroke. I found that the mechanisms underlying the relationship between women-specific risk factors and stroke, in particular the relationship between migraine and cerebral infarctions, seem to be particularly significant in the childbearing phase of life.In Part II, I described how health data from the EHR can be used to develop prediction models for the risk of myocardial infarction or stroke specifically for women under 50 years of age, and found that women-specific risk factors can add value in the predictions. However, there is still a long way to go to actually implement these models in practice, such as testing them on new datasets, and complying with current laws and regulations for safe application. Show less
This thesis describes the wide range of long-term consequences in stroke patients who received multidisciplinary rehabilitation.Over a third of them reported pain in the shoulder, arm, wrist or... Show moreThis thesis describes the wide range of long-term consequences in stroke patients who received multidisciplinary rehabilitation.Over a third of them reported pain in the shoulder, arm, wrist or hand. About the same percentage had low patient activation scores, which is a prerequisite for effective self-management to cope with the consequences of stroke. Almost half of patients who were working before the stroke managed to maintain paid employment for two and a half years. These patients were more satisfied with their participation than patients who did not return to work. Average independence in daily activities increased during rehabilitation. The Barthel Index was found to be more sensitive to measure change than the Utrecht Scale for Evaluation of Rehabilitation. Health-related quality of life increased on average from start of rehabilitation to one year afterwards. The average social costs in the first year were €63,045 for inpatients and €24,533 for outpatients. The burden of the nearest of stroke patients was investigated, which showed that a third of them experienced a high burden.In conclusion, the consequences of stroke can also remain present, worsen or develop in the long term and are present for the individual patient, their nearest and the healthcare system. Show less
Ali, M.; Meij, A. van der; Os, H.J.A. van; Zwet, E.W. van; Spaander, F.H.M.; Hofmeijer, J.; ... ; MR CLEAN Registry Investigators 2022
BackgroundWomen have been reported to have worse outcomes after endovascular treatment (EVT), despite a similar treatment effect in non-clinical trial populations. We aimed to assess sex... Show moreBackgroundWomen have been reported to have worse outcomes after endovascular treatment (EVT), despite a similar treatment effect in non-clinical trial populations. We aimed to assess sex differences at hospital presentation with respect to workflow metrics, prestroke disability, and presenting clinical symptoms. MethodsWe included consecutive patients from the Multicentre Randomised Controlled Trial of Endovascular Treatment for Acute Ischaemic Stroke in The Netherlands (MR CLEAN) Registry (2014-2018) who received EVT for anterior circulation large vessel occlusion (LVO). We assessed sex differences in workflow metrics, prestroke disability (modified Rankin Scale (mRS) score >= 1), and stroke severity and symptoms according to the National Institutes of Health Stroke Scale (NIHSS) score on hospital admission with logistic and linear regression analyses and calculated the adjusted OR (aOR). ResultsWe included 4872 patients (47.6% women). Compared with men, women were older (median age 76 vs 70 years) and less often achieved good functional outcome at 90 days (mRS <= 2: 35.2% vs 46.4%, aOR 0.70, 95% CI 0.60 to 0.82). Mean onset-to-door time was longer in women (2 hours 16 min vs 2 hours 7 min, adjusted delay 9 min, 95% CI 4 to 13). This delay contributed to longer onset-to-groin times (3 hours 26 min in women vs 3 hours 13 min in men, adjusted delay 13 min, 95% CI 9 to 17). Women more often had prestroke disability (mRS >= 1: 41.1% vs 29.1%, aOR 1.57, 95% CI 1.36 to 1.82). NIHSS on admission was essentially similar in men and women (mean 15 +/- 6 vs 15 +/- 6, NIHSS <10 vs >= 10, aOR 0.91, 95% CI 0.78 to 1.06). There were no clear sex differences in the occurrence of specific stroke symptoms. ConclusionWomen with LVO had longer onset-to-door times and more often prestroke disability than men. Raising awareness of these differences at hospital presentation and investigating underlying causes may help to improve outcome after EVT in women. Show less
Albalak, G.; Stijntjes, M.; Bodegom, D. van; Jukema, J.W.; Atsma, D.E.; Heemst, D. van; Noordam, R. 2022
Aims Little is known about the impact of daily physical activity timing (here referred to as 'chronoactivity') on cardiovascular disease (CVD) risk. We aimed to examined the associations between... Show moreAims Little is known about the impact of daily physical activity timing (here referred to as 'chronoactivity') on cardiovascular disease (CVD) risk. We aimed to examined the associations between chronoactivity and multiple CVD outcomes in the UK Biobank. Methods and results physical activity data were collected in the UK-Biobank through triaxial accelerometer over a 7-day measurement period. We used K-means clustering to create clusters of participants with similar chronoactivity irrespective of the mean daily intensity of the physical activity. Multivariable-adjusted Cox-proportional hazard models were used to estimate hazard ratios (HRs) comparing the different clusters adjusted for age and sex (model 1), and baseline cardiovascular risk factors (model 2). Additional stratified analyses were done by sex, mean activity level, and self-reported sleep chronotype. We included 86 657 individuals (58% female, mean age: 61.6 [SD: 7.8] years, mean BMI: 26.6 [4.5] kg/m(2)). Over a follow-up period of 6 years, 3707 incident CVD events were reported. Overall, participants with a tendency of late morning physical activity had a lower risk of incident coronary artery disease (HR: 0.84, 95%CI: 0.77, 0.92) and stroke (HR: 0.83, 95%CI: 0.70, 0.98) compared to participants with a midday pattern of physical activity. These effects were more pronounced in women (P-value for interaction = 0.001). We did not find evidence favouring effect modification by total activity level and sleep chronotype. Conclusion Irrespective of total physical activity, morning physical activity was associated with lower risks of incident cardiovascular diseases, highlighting the potential importance of chronoactivity in CVD prevention. Show less
Background The effects of thrombus imaging characteristics on procedural and clinical outcomes after ischemic stroke are increasingly being studied. These thrombus characteristics - for eg, size,... Show moreBackground The effects of thrombus imaging characteristics on procedural and clinical outcomes after ischemic stroke are increasingly being studied. These thrombus characteristics - for eg, size, location, and density - are commonly analyzed as separate entities. However, it is known that some of these thrombus characteristics are strongly related. Multicollinearity can lead to unreliable prediction models. We aimed to determine the distribution, correlation and clustering of thrombus imaging characteristics based on a large dataset of anterior-circulation acute ischemic stroke patients. Methods We measured thrombus imaging characteristics in the MR CLEAN Registry dataset, which included occlusion location, distance from the intracranial carotid artery to the thrombus (DT), thrombus length, density, perviousness, and clot burden score (CBS). We assessed intercorrelations with Spearman's coefficient (rho) and grouped thrombi based on 1) occlusion location and 2) thrombus length, density and perviousness using unsupervised clustering. Results We included 934 patients, of which 22% had an internal carotid artery (ICA) occlusion, 61% M1, 16% M2, and 1% another occlusion location. All thrombus characteristics were significantly correlated. Higher CBS was strongly correlated with longer DT (rho=0.67, p<0.01), and moderately correlated with shorter thrombus length (rho=-0.41, p<0.01). In more proximal occlusion locations, thrombi were significantly longer, denser, and less pervious. Unsupervised clustering analysis resulted in four thrombus groups; however, the cohesion within and distinction between the groups were weak. Conclusions Thrombus imaging characteristics are significantly intercorrelated - strong correlations should be considered in future predictive modeling studies. Clustering analysis showed there are no distinct thrombus archetypes - novel treatments should consider this thrombus variability. Show less
Objective We aimed to investigate whether serum anti-N-methyl-D-aspartate-receptor GluN1 (previously NR1) antibody (NMDAR1-abs) seropositivity impacts cognitive function (CF) in the long term... Show moreObjective We aimed to investigate whether serum anti-N-methyl-D-aspartate-receptor GluN1 (previously NR1) antibody (NMDAR1-abs) seropositivity impacts cognitive function (CF) in the long term following ischemic stroke. Methods Data were used from the PROSpective Cohort with Incident Stroke-Berlin. NMDAR1-abs (IgM/IgA/IgG) were measured with cell-based assays from serum obtained within 7 days after the first-ever stroke. Seropositivity was defined as titers >= 1:10, low titers as <= 1:100 and high titers as > 1:100. We assessed CF at 1, 2 and 3 years after stroke with the Telephone Interview for Cognitive Status-modified (TICS-m) and used crude and propensity score adjusted inverse probability weighted generalized linear models to estimate the impact of NMDAR1-abs serostatus on TICS-m. Results Data on NMDAR1-abs (median day of sampling = 4[IQR = 2-5]) were available in 583/621 PROSCIS-B patients (39% female; median NIHSS = 2[IQR = 1-4]; median MMSE = 28[IQR:26-30]), of whom 76(13%) were seropositive (IgM: n = 48/IgA: n = 43/IgG: n = 2). Any NMDAR1-abs seropositivity had no impact on TICS-m compared to seronegative patients (beta crude = 0.69[95%CI = - 0.84 to 2.23]; beta adjusted = 0.65[95%CI = - 1.00 to 2.30]). Patients with low titers scored better on TICS-m compared to seronegative patients (beta crude = 2.33[95%CI = 0.76 to 3.91]; beta adjusted = 2.47[95%CI = 0.75 to 4.19]); in contrast, patients with high titers scored lower on TICS-m (beta crude = -2.82[95%CI = - 4.90 to - 0.74], beta adjusted = - 2.96[95%CI = - 5.13 to - 0.80]), compared to seronegative patients. Conclusion In our study, NMDAR1-abs seropositivity did not affect CF over 3 years after a first mild to moderate ischemic stroke. CF differed according to NMDAR1-abs serum titer, with patients with high NMDAR1-abs titers having a less favorable cognitive outcome compared to seronegative patients. Show less
Holswilder, G.; Stuart, M.P.M.E.; Dompeling, T.; Kruyt, N.D.; Goeman, J.J.; Lugt, A. van der; ... ; MR CLEAN 2022
Introduction Vascular anatomy might affect endovascular treatment success in acute ischemic stroke patients with large vessel occlusion. We investigated the prognostic value of extracranial... Show moreIntroduction Vascular anatomy might affect endovascular treatment success in acute ischemic stroke patients with large vessel occlusion. We investigated the prognostic value of extracranial vascular characteristics on procedural time and revascularization success in patients with large vessel occlusion in the anterior cerebral circulation. Patients and methods We included 828 patients endovascularly treated within 6.5 hours of symptom onset from the Dutch MR CLEAN-Registry. We evaluated aortic arch configuration, stenosis and tortuosity of supra-aortic arteries, and internal carotid arteries (ICAs) on pre-intervention CTA. We constructed logistic prediction models for outcome variables procedural duration (>= 60 minutes) and non-successful revascularization (extended thrombolysis in cerebral infarction (eTICI) of 0-2A) using baseline characteristics and assessed the effect of extracranial vascular characteristics on model performance. Results Cervical ICA tortuosity and stenosis >= 99% improved prediction of long procedural duration compared with baseline characteristics from area under the curve of 0.61 (95% CI: 0.57-0.65) to 0.66 (95% CI: 0.62-0.70) (P < 0.001). Cervical ICA tortuosity was significantly associated with non-successful recanalization. Prediction of non-successful revascularization did not improve after including aortic arch elongation, acute take-off angle, aortic variant, origin stenosis of supra-aortic arteries, and cervical ICA tortuosity, with an area under the curve of 0.63 (95% CI: 0.59-0.67) compared with 0.59 (95% CI: 0.55-0.63) (P = 0.11). Conclusion Extracranial vascular characteristics have additional prognostic value for procedural duration, but not for revascularization success, compared with baseline characteristics. Performance of both prediction models is limited in patients treated for large vessel occlusion. Show less
Aims Persistence with direct oral anticoagulants (DOACs) has become a concern in non-valvular atrial fibrillation (NVAF) patients, but whether this affects prognosis is rarely studied. We... Show moreAims Persistence with direct oral anticoagulants (DOACs) has become a concern in non-valvular atrial fibrillation (NVAF) patients, but whether this affects prognosis is rarely studied. We investigated the persistence with oral anticoagulants (OACs) and its association with prognosis among a nationwide cohort of NVAF patients.Methods and results DOAC-naive NVAF patients who started to use DOACs for ischaemic stroke prevention between 2013 and 2018 were included using Dutch national statistics. Persistence with OACs was determined based on the presence of a 100-day gap between the last prescription and the end of study period. In 93 048 patients, 75.7% had a baseline CHA(2)DS(2)-VASc score of >= 2. The cumulative incidence of persistence with OACs was 88.1% [95% confidence interval (CI) 87.9-88.3%], 82.6% (95% CI 82.3-82.9%), 77.7% (95% CI 77.3-78.1%), and 72.0% (95% CI 71.5-72.5%) at 1, 2, 3, and 4 years after receiving DOACs, respectively. Baseline characteristics associated with better persistence with OACs included female sex, age range 65-74 years, permanent atrial fibrillation, previous exposure to vitamin K antagonists, stroke history (including transient ischaemic attack), and a CHA(2)DS(2)-VASc score >= 2. Non-persistence with OACs was associated with an increased risk of the composite outcome of ischaemic stroke and ischaemic stroke-related death [adjusted hazard ratio (aHR) 1.79, 95% CI 1.49-2.15] and ischaemic stroke (aHR 1.58, 95% CI 1.29-1.93) compared with being persistent with OACs.Conclusion At least a quarter of NVAF patients were non-persistent with OACs within 4 years, which was associated with poor efficacy of ischaemic stroke prevention. The identified baseline characteristics may help identify patients at risk of non-persistence. Show less
BackgroundEarly prediction of malignant infarction may guide treatment decisions. For patients who received endovascular treatment, the risk of malignant infarction is unknown and risk factors are... Show moreBackgroundEarly prediction of malignant infarction may guide treatment decisions. For patients who received endovascular treatment, the risk of malignant infarction is unknown and risk factors are unrevealed.AimsThe objective of this study is to estimate the incidence of malignant infarction after endovascular treatment in patients with an occlusion of the anterior circulation, to identify independent risk factors, and to establish a model for prediction.MethodsWe analyzed patients who received endovascular treatment for a large vessel occlusion in the anterior circulation within 6.5 h after symptom onset, included in the Dutch MR CLEAN Registry between March 2014 and June 2016. We compared patients with and without malignant infarction. Candidate predictors were incorporated in a multivariable binary logistic regression model. The final prediction model was established using backward elimination. Discrimination and calibration were evaluated with the area under the receiver operating characteristic curve (AUROC) and the Hosmer-Lemeshow test.ResultsOf 1445 patients, 82 (6%) developed malignant infarction. Independent predictors were lower age, higher National Institutes of Health Stroke Scale (NIHSS), lower alberta stroke program early CT score (ASPECTS), internal carotid artery occlusion, lower collateral score, longer times from onset to groin puncture, and unsuccessful reperfusion. The AUROC of a prediction model combining these features was 0.83 (95% confidence interval (CI): 0.79-0.88) and the Hosmer-Lemeshow test indicated appropriate calibration (P = 0.937).ConclusionThe risk of malignant infarction after endovascular treatment started within 6.5 h of stroke onset is approximately 6%. Successful reperfusion decreases the risk. A prediction model combining easily retrievable measures of age, ASPECTS, collateral status, and reperfusion shows good discrimination between patients who will develop malignant infarction and those who will not. Show less
Aim:To describe the course of depressive symptoms during the first 12 months post-stroke and its association with unmet needs. Methods:A prospective cohort study among stroke patients admitted to... Show moreAim:To describe the course of depressive symptoms during the first 12 months post-stroke and its association with unmet needs. Methods:A prospective cohort study among stroke patients admitted to inpatient rehabilitation. Depressive symptoms were assessed 3, 6, and 12 months post-stroke using the Hospital Anxiety and Depression Scale, and categorized into three trajectories: no (all times <8), non-consistent (one or two times >= 8), or persistent (all times >= 8) depressive symptoms. Unmet needs were assessed using the Longer-Term Unmet Needs questionnaire. Multivariable logistic regression analyses were used to investigate the association between depressive symptoms and unmet needs. Results:One hundred and fifty-one patients were included, of whom 95 (62.9%), 38 (25.2%), and 18 (11.9%) had no, non-consistent, or persistent depressive symptoms, respectively. Depressive symptoms three months post-stroke persisted in 43.9% and recurred in 19.5% of patients during the first 12 months post-stroke. Depressive symptoms were significantly associated with the occurrence and number of unmet needs (odds ratio 6.49;p = 0.003 and odds ratio 1.28;p = 0.005, respectively). Conclusions:Depressive symptoms three months post-stroke were likely to persist or recur during the first 12 months post-stroke. Depressive symptoms are associated with unmet needs. These results suggest that routine monitoring of depressive symptoms and unmet needs should be considered post-stroke. Show less
Kuhrij, L.S.; Marang-van de Mheen, P.J.; Berg-Vos, R.M. van den; Leeuw, F.E. de; Nederkoorn, P.J.; Lingsma, H.F. 2019
Background Intravenous thrombolysis (IVT) plays a prominent role in the treatment of acute ischemic stroke (AIS). The sooner IVT is administered, the higher the odds of a good outcome. Therefore,... Show moreBackground Intravenous thrombolysis (IVT) plays a prominent role in the treatment of acute ischemic stroke (AIS). The sooner IVT is administered, the higher the odds of a good outcome. Therefore, registering the in-hospital time to treatment with IVT, i.e. the door-to-needle time (DNT), is a powerful way to measure quality improvement. The aim of this study was to identify determinants that are associated with extended DNT. Methods Patients receiving IVT in 2015 and 2016 registered in the Dutch Acute Stroke Audit were included. DNT and onset-to-door time (ODT) were dichotomized using the median (i.e. extended DNT) and the 90th percentile (i.e. severely extended DNT). Logistic regression was performed to identify determinants associated with (severely) extended DNT/ODT and its effect on in-hospital mortality. A linear model with natural spline was used to investigate the association between ODT and DNT. Results Included were 9518 IVT treated patients from 75 hospitals. Median DNT was 26 min (IQR 20-37). Determinants associated with a higher likelihood of extended DNT were female sex (OR 1.17, 95% CI 1.05-1.31) and admission during off-hours (OR 1.12, 95% CI 1.01-1.25). Short ODT correlated with longer DNT, whereas longer ODT correlated with shorter DNT. Young age (OR 1.38, 95% CI 1.07-1.76) and admission to a comprehensive stroke center (OR 1.26, 1.10-1.45) were associated with severely extended DNT, which was associated with in-hospital mortality (OR 1.54, 95%CI 1.19-1.98). Conclusions Even though DNT in the Netherlands is short compared to other countries, lowering the DNT may be achievable by focusing on specific subgroups. Show less
Objectives: To describe health care use and its associated factors in the chronic phase after stroke. Methods: Patients completed a questionnaire on health care use, 58 years after hospital... Show moreObjectives: To describe health care use and its associated factors in the chronic phase after stroke. Methods: Patients completed a questionnaire on health care use, 58 years after hospital admission for stroke. It comprised the number of visits to physicians or other health care professionals over the past 6 months (Physician-visits; Low <= 1 or High >= 2) and other health care professionals (Low = 0 or High >= 1). In addition the Longer-term Unmet Needs after Stroke (LUNS), Frenchay Activity Index (FAI) and Physical and Mental Component Summary Scales of the Short Form 12 (PCS and MCS) were administered. Their associations with health care use (high, low) were determined by means of logistic regression analysis, adjusted for sex and age. Results: Seventy-eight of 145 patients (54%) returned the questionnaires; mean time-since-stroke was 80.3 months (SD10.2), age-at-stroke 61.7 years (SD13.8), and 46 (59%) were male. Physician contacts concerned mainly the general practitioner (58; 79.5%). Forty-one (52.6%) and 37 (47.4%) of the patients had a high use of physician and other health professionals visits, respectively. Worse PCS scores were associated with both high use of physician and other health professionals visits (OR.931; 95%CI.877-.987 and OR.941; 95%CI.891-.993, respectively), whereas the FAI, MCS, or LUNS were not related to health care use. Conclusions: Health care use after stroke is substantial and is related to physical aspects of health status, not to mental aspects, activities or unmet needs, suggesting a mismatch between patients' needs and care delivered. Show less
Meijeren-Pont, W. van; Volker, G.; Vlieland, T.V.; Goossens, P. 2019
Objective: To compare the responsiveness of the Utrecht Scale for Evaluation of Rehabilitation (USER) to the responsiveness of the Barthel Index in stroke patients in an inpatient rehabilitation... Show moreObjective: To compare the responsiveness of the Utrecht Scale for Evaluation of Rehabilitation (USER) to the responsiveness of the Barthel Index in stroke patients in an inpatient rehabilitation facility. Design: Observational study. Setting: Inpatient rehabilitation facility. Subjects: Consecutive stroke patients admitted for clinical rehabilitation. Interventions: Not applicable. Main measures: The USER and the Barthel Index were administered by a nurse at admission and discharge. The Effect Size and Standardized Response Mean (SRM) were calculated as measures of responsiveness. Results: From 198 (78%) of the 254 patients who were included in the study period, both admission and discharge data were available. At admission the mean score of the USER subscale Functional independence was 43.1 (SD = 18.9) and at discharge the mean score was 59.3 (SD = 13.8). The mean score of the Barthel Index at admission was 13.3 (SD = 5.4) and at discharge 18.4 (SD = 3.3). The Effect Size of the USER subscales Mobility, Self-care, Cognitive functioning, Pain, Fatigue and Mood were 0.85, 0.77, 0.48, 0.19, 0.40 and 0.28, respectively, and of the Barthel Index 0.94. The results for the SRM were in the same range. Conclusion: In inpatient rehabilitation after stroke, the USER was less responsive than the Barthel Index. Show less
Wentink, M.; Bodegom-Vos, L. van; Brouns, B.; Arwert, H.; Houdijk, S.; Kewalbansing, P.; ... ; Meesters, J. 2019
Background: Patient's expectations of the outcomes of rehabilitation may influence the outcomes and satisfaction with treatment.Objectives: For stroke patients in multidisciplinary rehabilitation,... Show moreBackground: Patient's expectations of the outcomes of rehabilitation may influence the outcomes and satisfaction with treatment.Objectives: For stroke patients in multidisciplinary rehabilitation, we aimed to explore patient's outcome expectations and their fulfilment as well as determinants.Methods: The Stroke Cohort Outcomes of REhabilitation (SCORE) study included consecutive stroke patients admitted to an inpatient rehabilitation facility after hospitalisation. Outcome expectations were assessed at the start of rehabilitation (admission) by using the three-item Expectancy scale (sum score range 3-27) of the Credibility/Expectancy Questionnaire (CEQ). After rehabilitation, patients answered the same questions formulated in the past tense to assess fulfilment of expectations. Baseline patient characteristics were recorded and health-related quality of life (EQ-5D) was measured at baseline and after rehabilitation. The number of patients with expectations unfulfilled or fulfilled or exceeded was computed by subtracting the admission and discharge CEQ Expectancy scores. Multivariable regression analysis was used to determine the factors associated with outcome expectations and their fulfilment, estimating odds ratios (ORs) and 95% confidence intervals (CIs).Results: We included 165 patients (96 males [58.2%], mean (SD) age 60.2 years [12.7]) who completed the CEQ Expectancy instrument at admission (median score 21.6, interquartile range [IQR] 17.0-24.0); 79 completed it both at admission (median score 20.6, IQR 16.6-24.4) and follow-up (median score 20.0, IQR 16.4-22.8). For 40 (50.6%) patients, expectations of therapy were fulfilled or exceeded. No patient characteristic at admission was associated with baseline CEQ Expectancy score. Odds of expectation fulfilment were associated with low expectations at admission (OR 0.70, 95% CI 0.60-0.83) and improved EQ-5D score (OR 1.35, 95% CI 1.04-0.75).Conclusions: In half of the stroke patients in multidisciplinary rehabilitation, expectations were fulfilled or exceeded, most likely in patients with low expectations at admission and with improved health-related quality of life. More research into the role of health professionals regarding the measurement, shaping and management of outcome expectations is needed. (C) 2018 Elsevier Masson SAS. All rights reserved. Show less
BACKGROUND The Shockless IMPLant Evaluation (SIMPLE) trial showed that defibrillation testing (DT) at the time of implantable cardioverter-defibrillator (ICD) implant did not improve shock efficacy... Show moreBACKGROUND The Shockless IMPLant Evaluation (SIMPLE) trial showed that defibrillation testing (DT) at the time of implantable cardioverter-defibrillator (ICD) implant did not improve shock efficacy or reduce mortality. There are no data regarding the risk of complications, including stroke, among patients with atrial fibrillation (AF) who undergo DT.OBJECTIVE The purpose of this prospectively planned substudy of SIMPLE was to evaluate the effect of DT vs no DT on clinical outcomes among patients with AF.METHODS We compared efficacy (failed appropriate shock/arrhythmic death) and safety between patients who had AF on their immediate preprocedural ECG to the rest of the study patients. Then among patients with AF we compared these outcomes between patients randomized to DT vs no DT.RESULTS Of the 2500 patients enrolled in SIMPLE, 251 (10%) were in AF immediately before ICD implant. AF patients had an increased risk of failed appropriate shock/arrhythmic death adjusted hazard ratio [HR] 1.64; 95% confidence interval [CI] 1.13-2.39; P = .009) and higher all-cause mortality (adjusted HR 1.58; 95% CI 1.2-2.08; P = .001). Among AF patients, perioperative complications and stroke did not significantly differ between DT vs no-DT groups (9.2% vs 5.4 0 /0; P = .2; and 1.7% vs 1.5%; P >.999, respectively). Failed appropriate shock or arrhythmic death occurred in 35 of 251 AF patients (14%), and the no-DT group proved not inferior to the DT group (HR 0.58; 95 0 /0 CI 0.30-1.15; P-noninferiority = .006).CONCLUSION ICD recipients with AF are at increased risk for adverse outcomes; however, DT does not improve arrhythmic survival or shock efficacy. There is no evidence that DT increased the occurrence of perioperative stroke. Show less
