Efficacy of a web-based healthcare innovation to advance the quality of life and care of patients with an implantable cardioverter defibrillator (ACQUIRE-ICD): a randomized controlled trial.

AIMS: Modern clinical management of patients with an implantable cardioverter defibrillator (ICD) largely consists of remote device monitoring, although a subset is at risk of mental health issues post-implantation. We compared a 12-month web-based intervention consisting of goal setting, monitoring of patients' mental health-with a psychological intervention if needed-psychoeducational support from a nurse, and an online patient forum, with usual care on participants' device acceptance 12 months after implantation. METHODS AND RESULTS: This national, multi-site, two-arm, non-blinded, randomized, controlled, superiority trial enrolled 478 first-time ICD recipients from all 6 implantation centres in Denmark. The primary endpoint was patient device acceptance measured by the Florida Patient Acceptance Survey (FPAS; general score range = 0-100, with higher scores indicating higher device acceptance) 12 months after implantation. Secondary endpoints included symptoms of depression and anxiety. The primary endpoint of device acceptance was not different between groups at 12 months [B = -2.67, 95% confidence interval (CI) (-5.62, 0.29), P = 0.08]. Furthermore, the secondary endpoint analyses showed no significant treatment effect on either depressive [B = -0.49, 95% CI (-1.19; 0.21), P = 0.17] or anxiety symptoms [B = -0.39, 95% CI (-0.96; 0.18), P = 0.18]. CONCLUSION: The web-based intervention as supplement to usual care did not improve patient device acceptance nor symptoms of anxiety and depression compared with usual care. This specific web-based intervention thus cannot be recommended as a standardized intervention in ICD patients.

Treatment-induced increase in total body potassium in patients at high risk of ventricular arrhythmias; a randomized POTCAST substudy.

OBJECTIVE: Hypokalemia is associated with increased risk of arrhythmias and it is recommended to monitor plasma potassium (p-K) regularly in at-risk patients with cardiovascular diseases. It is poorly understood if administration of potassium supplements and mineralocorticoid receptor antagonists (MRA) aimed at increasing p-K also increases intracellular potassium. METHODS: Adults aged≥18 years with an implantable cardioverter defibrillator (ICD) were randomized (1:1) to a control group or to an intervention that included guidance on potassium rich diets, potassium supplements, and MRA to increase p-K to target levels of 4.5-5.0 mmol/l for six months. Total-body-potassium (TBK) was measured by a Whole-Body-Counter along with p-K at baseline, after six weeks, and after six months. RESULTS: Fourteen patients (mean age: 59 years (standard deviation 14), 79% men) were included. Mean p-K was 3.8 mmol/l (0.2), and mean TBK was 1.50 g/kg (0.20) at baseline. After six-weeks, p-K had increased by 0.47 mmol/l (95%CI:0.14;0.81), p = 0.008 in the intervention group compared to controls, whereas no significant difference was found in TBK (44 mg/kg (-20;108), p = 0.17). After six-months, no significant difference was found in p-K as compared to baseline (0.16 mmol/l (-0.18;0.51), p = 0.36), but a significant increase in TBK of 82 mg/kg (16;148), p = 0.017 was found in the intervention group compared to controls. CONCLUSIONS: Increased potassium intake and MRAs increased TBK gradually and a significant increase was seen after six months. The differentially regulated p-K and TBK challenges current knowledge on potassium homeostasis and the time required before the full potential of p-K increasing treatment can be anticipated. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT03833089).

The effect of increased plasma potassium on myocardial function; a randomized POTCAST substudy.

Plasma potassium (p-K) in the high-normal range has been suggested to reduce risk of cardiovascular arrythmias and mortality through electrophysiological and mechanical effects on the myocardium. In this study, it was to investigated if increasing p-K to high-normal levels improves systolic- and diastolic myocardial function in patients with low-normal to moderately reduced left ventricular ejection fraction (LVEF). The study included 50 patients (mean age 58 years (SD 14), 81% men), with a mean p-K 3.95 mmol/l (SD 0.19), mean LVEF 48% (SD 7), and mean Global Longitudinal Strain (GLS) -14.6% (SD 3.1) patients with LVEF 35-55% from "Targeted potassium levels to decrease arrhythmia burden in high-risk patients with cardiovascular diseases trial" (POTCAST). Patients were given standard therapy and randomized (1:1) to an intervention that included guidance on potassium-rich diets, potassium supplements, and mineralocorticoid receptor antagonists targeting high-normal p-K levels (4.5-5.0 mmol/l). Echocardiography was done at baseline and after a mean follow-up of 44 days (SD 18) and the echocardiograms were analyzed for changes in GLS, mechanical dispersion, E/A, e', and E/e'. At follow-up, mean difference in changes in p-K was 0.52 mmol/l (95%CI 0.35;0.69), P<0.001 in the intervention group compared to controls. GLS was improved with a mean difference in changes of -1.0% (-2;-0.02), P<0.05 and e' and E/e' were improved with a mean difference in changes of 0.9 cm/s (0.02;1.7), P = 0.04 and ? 1.5 (-2.9;-0.14), P = 0.03, respectively. Thus, induced increase in p-K to the high-normal range improved indices of systolic and diastolic function in patients with low-normal to moderately reduced LVEF.

Global constructive work is associated with ventricular arrhythmias after cardiac resynchronization therapy.

AIMS: Non-invasive left ventricular (LV) pressure-strain loops provide a novel method for quantifying myocardial work by incorporating LV pressure in measurements of myocardial deformation. Early studies suggest that myocardial work parameters such as global constructive work (GCW) could be useful and reliable in arrhythmia prediction, particularly in patients undergoing cardiac resynchronization therapy (CRT). The aim of this study was to evaluate whether the magnitude of GCW was associated with the occurrence of ventricular arrhythmias in patients after CRT. METHODS AND RESULTS: Patients on guideline-recommended treatment with a CRT defibrillator (CRT-D) were evaluated by 2D speckle-tracking echocardiography including measurements of GCW at least 6 months after implantation. The primary outcome was a composite of appropriate defibrillator therapy and sustained ventricular arrhythmia under the monitor zone. A total of 162 patients [mean age 66 years (±10), 122 males (75%)] were included. Sixteen (10%) patients experienced the primary outcome during a median follow-up of 18 months (interquartile range: 12-25) after the performance of index echocardiography. Patients with a below-median GCW (<1473 mmHg%) had a hazard ratio (HR) for the outcome of 8.14 [95% confidence interval (CI): 1.83-36.08], P = 0.006 compared with patients above the median in a univariate model and remained an independent predictor after multivariate adjustment for the estimated glomerular filtration rate and QRS duration [HR 4.75 (95% CI: 1.01-22.28), P < 0.05]. CONCLUSION: In patients treated with CRT-D, a GCW below median level was associated with a five-fold increase in the risk of ventricular arrhythmias.

Long-term cardiovascular outcomes among immigrants and non-immigrants in cardiac resynchronization therapy: a nationwide study.

AIMS: To date, potential differences in outcomes for immigrants and non-immigrants with a cardiac resynchronization therapy (CRT), in a European setting, remain underutilized and unknown. Hence, we examined the efficacy of CRT measured by heart failure (HF)-related hospitalizations and all-cause mortality among immigrants and non-immigrants. METHODS AND RESULTS: All immigrants and non-immigrants who underwent first-time CRT implantation in Denmark (2000-2017) were identified from nationwide registries and followed for up to 5 years. Differences in HF related hospitalizations and all-cause mortality were evaluated by Cox regression analyses. From 2000 to 2017, 369 of 10 741 (3.4%) immigrants compared with 7855 of 223 509 (3.5%) non-immigrants with a HF diagnosis underwent CRT implantation. The origins of the immigrants were Europe (61.2%), Middle East (20.1%), Asia-Pacific (11.9%), Africa (3.5%), and America (3.3%). We found similar high uptake of HF guideline-directed pharmacotherapy before and after CRT and a consistent reduction in HF-related hospitalizations the year before vs. the year after CRT (61% vs. 39% for immigrants and 57% vs. 35% for non-immigrants). No overall difference in 5-year mortality among immigrants and non-immigrants was seen after CRT [24.1% and 25.8%, respectively, P-value = 0.50, hazard ratio (HR) = 1.2, 95% confidence interval (CI): 0.8-1.7]. However, immigrants of Middle Eastern origin had a higher mortality rate (HR = 2.2, 95% CI: 1.2-4.1) compared with non-immigrants. Cardiovascular causes were responsible for the majority of deaths irrespective of immigration status (56.7% and 63.9%, respectively). CONCLUSION: No overall differences in efficacy of CRT in improving outcomes between immigrants and non-immigrants were identified. Although numbers were low, a higher mortality rate among immigrants of Middle Eastern origin was identified compared with non-immigrants.

Carpal Tunnel Syndrome in Patients Who Underwent Pacemaker Implantation and Relation to Amyloidosis, Heart Failure, and Mortality.

Advances in treatment warrant earlier diagnosis of cardiac amyloidosis (CA). Common cardiac and extracardiac manifestations of CA, such as pacemaker implantation and carpal tunnel syndrome (CTS), might provide screening opportunities for CA. However the association between CTS and CA in patients undergoing pacemaker implantation has not been well studied. This study examined the association between previous CTS surgery and adverse cardiovascular outcomes in patients who underwent pacemaker implantation. Using Danish nationwide registries, we identified all patients ≥50 years who underwent first-time pacemaker implantation during 2000 to 2018, examining the association between previous CTS surgery and adverse cardiovascular outcomes 5 years after pacemaker implantation. Cumulative incidence functions and Cox proportional hazard models were used to assess the differences. Among 57,315 patients who underwent pacemaker implantation, 2.2% (n = 1,266) had previous CTS surgery. Patients in the CTS cohort were older, more often female, and had more co-morbidities than patients without CTS. The cumulative 5-year mortality was higher among patients with CTS (44.6% [41.1% to 47.9%] versus 40.2% [39.7% to 40.6%], p = 0.04). In the adjusted models, previous CTS surgery was not associated with increased 5-year mortality, but it was associated with an increased rate of hospitalization for new-onset heart failure, (hazard ratio 1.32 [1.11 to 1.57], p = 0.002) and a higher risk of amyloidosis diagnosis after pacemaker implantation (hazard ratio 7.72 [2.96 to 20.10], p <0.0001), compared with no previous CTS surgery. In patients who underwent pacemaker implantation, adjusted models showed that previous CTS surgery was associated with a higher incidence of hospitalization for new-onset heart failure and amyloidosis diagnosis after pacemaker implantation. Screening for CA may be considered in patients undergoing pacemaker implantation.

Cause-specific death and risk factors of 1-year mortality after implantable cardioverter-defibrillator implantation: a nationwide study.

AIMS: Current treatment guidelines recommend implantable cardioverter-defibrillators (ICDs) in eligible patients with an estimated survival beyond 1 year. There is still an unmet need to identify patients who are unlikely to benefit from an ICD. We determined cause-specific 1-year mortality after ICD implantation and identified associated risk factors. METHODS AND RESULTS: Using Danish nationwide registries (2000-2017), we identified 14 516 patients undergoing first-time ICD implantation for primary or secondary prevention. Risk factors associated with 1-year mortality were evaluated using multivariable logistic regression. The median age was 66 years, 81.3% were male, and 50.3% received an ICD for secondary prevention. The 1-year mortality rate was 4.8% (694/14 516). ICD recipients who died within 1 year were older and more comorbid compared to those who survived (72 vs. 66 years, P < 0.001). Risk factors associated with increased 1-year mortality included dialysis [odds ratio (OR): 3.26, confidence interval (CI): 2.37-4.49], chronic renal disease (OR: 2.14, CI: 1.66-2.76), cancer (OR: 1.51, CI: 1.15-1.99), age 70-79 years (OR: 1.65, CI: 1.36-2.01), and age ≥80 years (OR: 2.84, CI: 2.15-3.77). The 1-year mortality rates for the specific risk factors were: dialysis (13.8%), chronic renal disease (13.1%), cancer (8.5%), age 70-79 years (6.9%), and age ≥80 years (11.0%). Overall, the most common causes of mortality were related to cardiovascular diseases (62.5%), cancer (10.1%), and endocrine disorders (5.0%). However, the most common cause of death among patients with cancer was cancer-related (45.7%). CONCLUSION: Among ICD recipients, mortality rates were low and could be indicative of relevant patient selection. Important risk factors of increased 1-year mortality included dialysis, chronic renal disease, cancer, and advanced age.

A Randomized Trial of His Pacing Versus Biventricular Pacing in Symptomatic HF Patients With Left Bundle Branch Block (His-Alternative).

OBJECTIVES: This study sought to compare 2 ways of achieving cardiac resynchronization. BACKGROUND: Cardiac resynchronization therapy (CRT) in patients with symptomatic heart failure and left bundle branch block (LBBB) can be achieved with His-bundle pacing correcting the bundle branch block (His-CRT). The present study is the largest randomized study comparing His-CRT and biventricular pacing (BiV-CRT) to date. METHODS: Fifty patients with symptomatic heart failure, left ventricular ejection fraction (LVEF) ≤35% and LBBB according to electrocardiography were randomized 1:1 to His-CRT or BiV-CRT and followed for 6 months. At implantation, 7 patients crossed over from His-pacing to LV-pacing in the His-CRT group and 1 patient crossed over from LV-pacing to His-pacing in the BiV-CRT group. RESULTS: His-corrective pacing was achieved in 72% of the patients in the His-CRT group. Intention-to-treat 6-month follow-up LVEF increased by 16 ± 7% in the His-CRT group compared with 13 ± 6% in the BiV-CRT group (nonsignificant) and improvements were seen in clinical and physical parameters in both treatment arms with no significant differences between the groups. Pacing thresholds were higher for His-CRT compared with BiV-CRT both at implantation (1.8 ± 1.2 V vs. 1.2 ± 0.8 V; p < 0.01) and at 6-month follow-up (2.3 ± 1.4 V vs. 1.4 ± 0.5 V; p < 0.01). The per-protocol LVEF was significantly higher at 6 months (48 ± 8% vs. 42 ± 8%; p < 0.05) and the end-systolic volume was lower (65 ± 22 ml vs. 83 ± 27 ml; p < 0.05) in His-CRT patients compared with BiV-CRT. CONCLUSIONS: In heart failure patients with LBBB, His-CRT provided similar clinical and physical improvement compared with BiV-CRT at the expense of higher pacing thresholds.

Left bundle branch block without a typical contraction pattern is associated with increased risk of ventricular arrhythmias in cardiac resynchronization therapy patients.

Cardiac resynchronization therapy (CRT) reduces the risk of ventricular arrhythmias (VA) in heart failure (HF) patients with left bundle branch block (LBBB) while the effect is less clear among non-LBBB patients. This study aimed to investigate if absence of LBBB features whether by echocardiography or strict ECG criteria would identify patients at risk of developing VA in a cohort with LBBB according to conventional ECG criteria. Two hundred six CRT candidates were prospectively included from 2 centers. Prior to CRT presence of a typical LBBB contraction pattern was identified using longitudinal strain in the apical 4-chamber view. All preimplantation ECGs were categorized as LBBB or non-LBBB according to Strauss´ strict criteria. Primary end-point was defined as any appropriate antitachycardia pacing (ATP) or shock therapy within 2 years after CRT implantation. A total of 129 (63%) patients had a typical LBBB contraction pattern, while 134 (66%) met the strict ECG criteria. Over 2 years, 45 patients (22%) experienced VA. Absence of a typical LBBB contraction pattern was independently associated with an increased risk of VA (hazard ratio ([HR] 1.89; 95% CI 1.04 to 3.44; p: 0.036). Strict LBBB was not independently associated with the occurrence of VA. Fulfilling neither strict ECG nor echocardiographic criteria for LBBB was associated with a 3.3-fold increase in risk of VA ([HR] 3.34; 95% CI 1.75 to 6.94; (p < 0.001). The risk of VA was almost 2-fold higher if a typical LBBB contraction pattern was absent prior to CRT.

Temporal Incidence of Appropriate and Inappropriate Therapy and Mortality in Secondary Prevention ICD Patients by Cardiac Diagnosis.

OBJECTIVES: This study sought to estimate the temporal development in rates and incidences of appropriate and inappropriate implantable cardioverter-defibrillator (ICD) therapy and shocks by cardiac diagnosis in a real-world population of patients with secondary prevention ICDs. BACKGROUND: Data on cardiac diagnoses and temporal development of ICD therapies in patients with secondary prevention ICDs are limited. METHODS: Patients (N = 4,587) with a secondary prevention ICD were identified from the Danish Pacemaker and ICD Register (January 1, 2007, to December 31, 2016) and linked to nationwide administrative registers. The outcome of appropriate and inappropriate ICD therapy and all-cause mortality were analyzed by annual event rates, cumulative incidence plots, and Cox regression models. RESULTS: During a mean follow-up of 3.6 ± 2.4 years, 1,362 patients (30%) experienced appropriate ICD therapy (16.8% shocks), and 350 patients (7.6%) experienced inappropriate ICD therapy (4.6% shocks). From 2007 to 2016, there was a significant temporal reduction in both appropriate and inappropriate ICD therapy from 28.2 (95% confidence interval [CI]: 21.6 to 37.0) to 7.9 (95% CI: 6.8 to 9.1) and 10.0 (95% CI: 6.4 to 15.5) to 1.0 (95% CI: 0.7 to 1.5) per 100 person-years (p for trends <0.001). Multivariate Cox regression analyses showed that arrhythmogenic right ventricular cardiomyopathy was associated with the highest probability of appropriate ICD therapy (hazard ratio: 2.45; 95% CI: 1.77 to 3.39; p < 0.0001), whereas patients with hypertrophic cardiomyopathy had the lowest probability (hazard ratio: 0.62; 95% CI: 0.42 to 0.93; p = 0.0196) when compared to patients with ischemic heart disease. CONCLUSIONS: In this nationwide real-life cohort of patients with secondary prevention ICDs, we observed a significant temporal decline in delivered appropriate and inappropriate shocks and ICD therapies in the last decade. A large proportion of patients still experienced ICD therapy but with significant differences by cardiac diagnosis.

Left axis deviation in patients with left bundle branch block is a marker of myocardial disease associated with poor response to cardiac resynchronization therapy.

AIMS: Patients with left axis deviation (LAD) and left bundle branch block (LBBB) show less benefit from cardiac resynchronization therapy (CRT) compared to other LBBB-patients. This study investigates the reasons for this. METHODS: Sixty-eight patients eligible for CRT were included. Patients were divided into groups according to QRS-axis; normal axis (NA), left axis deviation (LAD) and right axis deviation (RAD). Before CRT implantation CMR imaging was performed to evaluate scar tissue. Echocardiography was performed before and after implantation. The electrical substrate was assessed by measuring interlead electrical delays. Response was evaluated after 8 months by left ventricular (LV) remodelling and clinical response. RESULTS: Forty-four (65%) patients were responders in terms of LV remodelling. The presence of LAD was found to be independently associated with a poor LV remodelling non-response OR 0.21 [95% CI 0.06-0.77] (p = 0.02). Patients with axis deviation had more myocardial scar tissue (1.3 ±â€¯0.6 vs. 0.9 ±â€¯0.6, P = 0.04), more severe LV hypertrophy (14 (64%) and 6 (60%) vs. 7 (29%), P = 0.05) and tended to have a shorter interlead electrical delay than patients with NA (79 ±â€¯40 ms vs. 92 ±â€¯48 ms, P = 0.07). A high scar tissue burden was more pronounced in non-responders (1.4 ±â€¯0.6 vs. 1.0 ±â€¯0.5, P = 0.01). CONCLUSIONS: LAD in the presence of LBBB is a predictor of poor outcome after CRT. Patients with LBBB and LAD have more scar tissue, hypertrophy and less activation delay.

A large inherent delay between the ECG and EGM signals in the pacing system analyzer from Medtronic makes it unsuitable to estimate timing events during CRT implantation.

BACKGROUND: Following an observation of pacing markers being placed after the beginning of the paced QRS complex when using the analyzer module 2290 of the Medtronic 2090 programmer, we decided to determine the delay between the EGM and the ECG channels and comparing it to the St Jude Merlin® programmer. METHODS: We obtained ECG lead I simultaneously from both the ECG cable and by attaching the atrial clamps of the EGM cable on the left and right shoulder. We were then able to directly measure any delay. Then we compared measurements of start QRS to LV sense (qLV) in patients implanted with CRT in the last year where we had data on qLV at implant and at 6-month follow-up. At implant qLV was measured by the analyzer modules and at 6-month follow-up, it was measured in the pacing devices. RESULTS: We found that the delay between the EGM and ECG channels was 59 ±â€¯4 ms in the Medtronic analyzer (ECG first) and 4 ±â€¯3 ms in the St Jude analyzer (EGM first). In 16 CRT patients where the Medtronic analyzer had been used, the difference between qLV at implant and qLV at 6 months was 60 ±â€¯27 ms whereas this difference was 2 ±â€¯28 ms in 34 CRT patients where the St Jude analyzer had been used (p < 10-7). CONCLUSION: There is a delay of about 60 ms between the EGM and ECG channels of 2290 analyzer module of the Medtronic 2090 programmer making it unsuitable for determining timing measurements between QRS and EGM.

Incidence of appropriate implantable cardioverter-defibrillator therapy and mortality after implantable cardioverter-defibrillator generator replacement: results from a real-world nationwide cohort.

AIMS: The safety of omitting implantable cardioverter-defibrillator (ICD) generator replacement in patients with no prior appropriate therapy, comorbid conditions, and advanced age is unclear. The aim was to investigate incidence of appropriate ICD therapy after generator replacement. METHODS AND RESULTS: We identified patients implanted with a primary prevention ICD (n = 4630) from 2007 to 2016, who subsequently underwent an elective ICD generator replacement (n = 670) from the Danish Pacemaker and ICD Register. The data were linked to other databases and evaluated the outcomes of appropriate therapy and death. Predictors of ICD therapy were identified using multivariate Cox regression analyses. A total of 670 patients underwent elective ICD generator replacement. Of these, 197 (29.4%) patients had experienced appropriate therapy in their 1st generator period. During follow-up of 2.0 ± 1.6 years, 95 (14.2%) patients experienced appropriate therapy. Predictors of appropriate therapy in 2nd generator period was low initial left ventricular ejection fraction (≤25%) [hazard ratio (HR) 1.87, confidence interval (CI) 1.13-1.95] and appropriate therapy in 1st generator period (HR 3.95, CI 2.57-6.06). For patients with appropriate therapy in 1st generator period, 4-year incidence of appropriate therapy was 50.6% vs. 16.4% in those without (P < 0.001). Among patients >80 years with no prior appropriate therapy 8.8% of patients experienced appropriate therapy after replacement. Comorbidity burden and advanced age were associated with reduced device utilization after replacement and a high competing risk of death without preceding appropriate therapy. CONCLUSION: A significant residual risk of appropriate therapy in the 2nd generator was present even among patients with advanced age and with a full prior generator period without any appropriate ICD events.

Clinical outcome in patients with implantable cardioverter-defibrillator and cancer: a nationwide study.

AIMS: Patients with cancer are insufficiently represented in randomized clinical trials investigating efficacy of implantable cardioverter-defibrillators (ICDs). We aimed to describe outcomes in patients with a pre-existing diagnosis of cancer at time of ICD implantation. METHODS AND RESULTS: We utilized Danish nationwide registries to identify primary and secondary prevention ICD implantations from 2007 to 2012. Multivariable Cox models were used to assess the risk of appropriate ICD therapy and mortality in patients with and without cancer at time of implantation. During a median follow-up of 2.1 years, 2935 primary prevention ICD and 2730 secondary prevention ICD implantations were identified. Out of these [289 (5.1%)] had pre-existing cancer [primary 140 (4.8%), secondary 149 (5.5%)]. No differential risk for appropriate ICD therapy was found between patients with or without cancer, [primary cancer: 19/140, no cancer: 380/2795, hazard ratio (HR) = 1.07 (0.67-1.69)] and [secondary cancer: 42/149, no cancer: 699/2581, HR = 1.28 (0.93-1.75)]. In primary patients, cancer was not associated with higher risk of 1-year [cancer: 10/140, no cancer: 133/2795, HR = 1.20 (0.84-2.28)] or all-time mortality [cancer: 22/140, no cancer: 339/2795, HR = 1.13 (0.74-1.75)]. In secondary patients, cancer was associated with a higher 1-year [cancer: 19/149, no cancer: 108/2581, HR = 2.62 (1.60-4.29)] and all-time mortality [cancer: 44/149, no cancer: 315/2581, HR = 2.36 (1.71-3.24)]. CONCLUSION: Implantable cardioverter-defibrillators were implanted in a minority of cancer patients. No difference in risk of appropriate therapy was observed between cancer and non-cancer patients, regardless of implant indication. Cancer was associated with increased mortality in secondary prevention ICD patients, but not in primary prevention ICD patients. In secondary prevention ICD patients, the majority of deaths were attributable to cancer.

Risk of post-discharge fall-related injuries among adult patients with syncope: A nationwide cohort study.

BACKGROUND: Syncope could be related to high risk of falls and injury in adults, but documentation is sparse. We examined the association between syncope and subsequent fall-related injuries in a nationwide cohort. METHODS: By cross-linkage of nationwide registers, all residents ≥18 years with a first-time diagnosis of syncope were identified between 1997-2012. Syncope patients were matched 1:1 with individuals from the general population. The absolute one-year risk of fall-related injuries, defined as fractures and traumatic head injuries requiring hospitalization, was calculated using Aalen-Johansen estimator. Ratios of the absolute one-year risk of fall-related injuries (ARR) were assessed by absolute risk regression analysis. RESULTS: We identified 125,763 patients with syncope: median age 65 years (interquartile range 46-78). At one year, follow-up was complete for 99.8% where a total of 8394 (6.7%) patients sustained a fall-related injury requiring hospitalization, of which 1606 (19.1%) suffered hip fracture. In the reference group, 4049 (3.2%) persons had a fall-related injury. The one-year ARR of a fall-related injury was 1.79 (95% confidence interval 1.72-1.87, P<0.001) in patients with syncope compared with the reference group; however, increased ARR was not exclusively in older patients. Factors independently associated with increased ARR of fall-related injuries in the syncope population were: injury in past 12 months, 2.39 (2.26-2.53, P<0.001), injury in relation to the syncope episode, 1.62 (1.49-1.77, P<0.001), and depression, 1.37 (1.30-1.45, P<0.001). CONCLUSION: Patients with syncope were at 80% increased risk of severe fall-related injuries within the year following discharge. Notably, increased risk was not exclusively in older patients.

Effectiveness of a comprehensive interactive eHealth intervention on patient-reported and clinical outcomes in patients with an implantable cardioverter defibrillator [ACQUIRE-ICD trial]: study protocol of a national Danish randomised controlled trial.

BACKGROUND: In Denmark and other countries, there has been a shift in the management of patients with an implantable cardioverter defibrillator (ICD) with remote device monitoring largely replacing in-hospital visits. Less patient-nurse and patient-physician interaction may lead to gaps in patients' quality of care and impede patients' adaptation to living successfully with the ICD. A comprehensive eHealth intervention that include goal-setting, monitoring of symptoms of depression, anxiety, and quality of life, psychological treatment, information provision, supportive tools, online dialogues with nursing staff and access to an online community network, may help fill these gaps and be particularly beneficial to patients who suffer from anxiety and depression. This study will evaluate the effectiveness of the ACQUIRE-ICD care innovation, a comprehensive and interactive eHealth intervention, on patient-reported and clinical outcomes. METHODS: The ACQUIRE-ICD study is a multicenter, prospective, two-arm, unblinded randomised controlled superiority trial that will enroll 478 patients implanted with a first-time ICD or ICD with cardiac synchronisation therapy (CRT-D) from the six implanting centers in Denmark. The trial will evaluate the clinical effectiveness and cost-effectiveness of the ACQUIRE-ICD care innovation, as add-on to usual care compared with usual care alone. The primary endpoint, device acceptance, assessed with the Florida Patient Acceptance Survey, is evaluated at 12 months' post implant. Secondary endpoints, evaluated at 12 and 24 months' post implant, include patient-reported outcomes, return to work, time to first ICD therapy and first hospitalisation, mortality and cost-effectiveness. DISCUSSION: The effectiveness of a comprehensive and interactive eHealth intervention that relies on patient-centred and personalised tools offered via a web-based platform targeted to patients with an ICD has not been assessed so far. The ACQUIRE-ICD care innovation promotes and facilitates that patients become active participants in the management of their disease, and as such addresses the need for a more patient-centered disease-management approach. If the care innovation proves to be beneficial to patients, it may not only increase patient empowerment and quality of life but also free up time for clinicians to care for more patients. TRIAL REGISTRATION: The trial has been registered on https://clinicaltrials.gov/ct2/show/NCT02976961 on November 30, 2016 with registration number [ NCT02976961 ].

Shortening of paced QRS duration after electrocardiographic optimization of left ventricular pacing vector in patients treated with Cardiac Resynchronization Therapy.

Background: Choice of left ventricular pacing vector (LVPV) affects the QRS-duration (QRSd) in patients with Cardiac Resynchronization Therapy (CRT). It is not known whether testing all LVPVs reduces QRSd compared to device-based "standard-programming". Methods: In patients implanted with CRT several ECGs were recorded for each usable LVPV (no phrenic nerve stimulation and threshold <3.5 V) and during "standard-programming" after device-based optimization of AV/VV delays. Results: 22 consecutive patients were included. Average QRSd reduction after CRT + "standard-programming" was 27.3 ±â€¯22 ms. Additional QRSd-reduction was possible in 4 patients by changing the LVPV, and in 5 other patients after optimization of AV- and VV delays without changing LVPV. Conclusions: Shortening of QRSd compared to "standard-programming" was possible approximately 40% of these patients treated with CRT by testing all LVPVs and re-optimizing AV/VV delays during follow-up. Studies of clinical effects are needed.

The use of guideline recommended beta-blocker therapy in primary prevention implantable cardioverter defibrillator patients: insight from Danish nationwide registers.

Aims: We aimed to examine the use of guideline recommended beta-blocker therapy prior to and after primary prevention implantable cardioverter defibrillator (ICD) implantation in a 'real-life' setting. Methods and results: From the Danish Pacemaker and ICD Registry we identified all 1st-time primary prevention ICD and cardiac resynchronization therapy defibrillator (CRT-D) implantations in Denmark from 2007-12 (n = 2935). Use of beta-blocker, type and dose was acquired through the Danish Prescription Registry. According to guideline recommendations, we defined target daily doses as ≥50 mg carvedilol and ≥200 mg metoprolol. Prior to implantation 2427 of 2935 (83%) patients received beta-blocker therapy, with 2166 patients (89%) having initiated treatment 3 months or more prior to implantation. The majority of patients was prescribed carvedilol (52%) or metoprolol (41%). Patients on carvedilol reached target dosages more frequently than patients on metoprolol, with 39% of patients on carvedilol and 26% of patients on metoprolol at the time of implantation (P < 0.001 for all time-points). Increase in proportion of patients reaching target daily doses was observed for both carvedilol and metoprolol after ICD implantation. Carvedilol treatment was a strong predictor for being on target dose of BB at time of implant, as was treatment with angiotensin-converting enzyme inhibitors and/or spironolactone, no history of myocardial infarction, younger age and less pronounced heart failure symptoms. Conclusion: In a real-life setting of primary prevention ICD patients, 39% and 26% of patients were titrated to optimal target dose of carvedilol or metoprolol prior to implantation. A higher proportion of patients on carvedilol reached target dose, as compared with metoprolol.

The impact of co-morbidity burden on appropriate implantable cardioverter defibrillator therapy and all-cause mortality: insight from Danish nationwide clinical registers.

AIMS: In a nationwide cohort of primary (PP-ICD) and secondary prevention (SP-ICD) implantable cardioverter defibrillator (ICD) patients, we aimed to investigate the association between co-morbidity burden and risk of appropriate ICD therapy and mortality. METHODS AND RESULTS: We identified all patients >18 years, implanted with first-time PP-ICD (n = 1873) or SP-ICD (n = 2461) in Denmark from 2007 to 2012. Co-morbidity was identified in administrative registers of hospitalization and drug prescription from pharmacies. Co-morbidity burden was defined as the number of pre-existing non-ICD indication-related co-morbidities including atrial fibrillation, diabetes, chronic obstructive pulmonary disease, chronic renal disease, liver disease, cancer, chronic psychiatric disease, and peripheral and/or cerebrovascular disease, and divided into four groups (co-morbidity burden 0, 1, 2, and ≥3). Through Cox models, we assessed the impact of co-morbidity burden on appropriate ICD therapy and mortality. Increasing co-morbidity burden was not associated with increased risk of appropriate therapy, irrespective of implant indication [all hazard ratios (HRs) 1.0-1.4, P = NS]. Using no co-morbidities as reference, increasing co-morbidity burden was associated with increased mortality risk in PP-ICD patients (co-morbidity burden 1, HR 2.1; comorbidity burden 2, HR 3.7; co-morbidity burden ≥3, HR 6.6) (all P < 0.001) and SP-ICD patients (co-morbidity burden 1, HR 2.2; co-morbidity burden 2, HR 3.8; co-morbidity burden ≥3, HR 5.8). With increasing co-morbidity burden, an increasing frequency of patients died without having utilized their device, with 72% PP-ICD and 45% SP-ICD patients with co-morbidity burden ≥3 dying without prior appropriate ICD therapy. CONCLUSION: Increasing co-morbidity burden was not associated with increased risk of appropriate ICD therapy. With increasing co-morbidity burden, mortality increased, and a higher proportion of patients died, without ever having utilized their device.