BACKGROUND:Cholecystokinin (CCK) is secreted from the intestines in response to food intake. We previously reported that the CCK gene is also expressed in the mammalian heart, and it has been hypothesized that proCCK could be a novel cardiac biomarker. However, it is not known whether cardiac gene expression leads to secretion in humans. PURPOSE:To investigate myocardial secretion of proCCK in patients with heart failure with reduced ejection fraction (HFrEF) or arrythmias. METHODS:A total of 115 patients undergoing invasive cardiac procedures were included: 55 with HFrEF (67 years [interquartile range (IQR) 60-76], 72.7 % male, LVEF 30 % [IQR 20-35]), and 60 without HFrEF (26 with Wolff-Parkinson-White syndrome (WPW) (30 years [IQR 26-39], 61.5 % male), and 34 with atrial fibrillation (AFIB) (66 years [IQR 60-71], 61.8 % male)). Blood was collected from the coronary sinus (CS) as well as the left atrium or femoral artery (A) to determine the transcardiac concentration gradient (TCproCCK) (CS proCCK concentration - A proCCK concentration). Radioimmunoassays were used for measurements of plasma hormones. RESULTS:TCproCCK across failing hearts was 0.05 pmol/l (IQR: -1.49-2.67) (p = 0.365). In non-failing hearts, TCproCCK was 0.35 pmol/l (IQR: -1.57-1.29) (p = 0.778) for WPW and 0.68 pmol/l (IQR: -1.58-3.28) (p = 0.133) for AFIB. Transcardiac gradients for N-terminal pro B-type natriuretic peptide (NT-proBNP) were observed in all groups. CONCLUSIONS:No evidence of net myocardial secretion of proCCK was found in either failing or structurally normal hearts, questioning its proposed role as a cardiac biomarker.

Background Treatment with implantable cardioverter-defibrillators (ICDs) effectively prevents sudden cardiac death (SCD) in patients with hypertrophic cardiomyopathy (HCM). Identifying patients most likely to benefit from a primary prevention ICD remains challenging. We aimed to investigate the long-term incidence of ICD therapy in patients with HCM according to SCD-risk at baseline.Methods The study retrospectively included all patients with HCM treated with an ICD for primary or secondary prevention between 1995 and 2022 in Eastern Denmark. Medical records for each patient were evaluated. Patients were stratified into risk groups according to the European Society of Cardiology HCM Risk-SCD score.Results We included 208 patients (66% male) with HCM and an ICD for primary (78%) or secondary prevention (22%). During a median 10-year follow-up, 66 patients (32%) received appropriate ICD therapy (antitachycardia pacing and/or shock), while 20 (10%) received inappropriate therapy. Patients with an ICD implanted for secondary prevention were almost twice as likely to receive appropriate therapy compared with patients with an ICD implanted for primary prevention (47% vs 28%, p=0.02). The 5-year cumulative incidences of appropriate shock therapy were 17% in patients with a high HCM Risk-SCD score, 16% in patients with an intermediate-risk score and 6% in patients with a low-risk score. A high-risk score was associated with higher cumulative incidence of appropriate shock therapy (p=0.012).Conclusion One-third of patients with HCM treated with an ICD experienced appropriate ICD therapy. The HCM-Risk SCD score adequately distinguished between low-risk and high-risk patients among those who underwent ICD implantation. Further improvements of risk-tools are needed to identify a larger proportion of the two-thirds of patients who did not benefit from ICD implantation after 10 years of observation.

Abstract Aim To investigate whether a compressive dressing after pacemaker or implantable cardioverter defibrillator (ICD) implantation and replacement applied for three hours can prevent bleeding, hematomas and pain. Method The study was a quasi-experimental interventional study including patients scheduled for implantation or replacement of a pacemaker or an ICD. In alternating months patients either received a compressive dressing (intervention group) or no compressive dressing (control group). Patients were followed at the catheterization lab, for three hours on the ward and until the first outpatient control visit (after 1-3 months). Outcomes was: Bleeding graded as bleeding, oozing or pocket-hematomas. Hematomas were measured by degrees and size. Pain was rated in a numerical rank scale (NRS). Results A total of 242 elective patients were included (intervention group n=114, control group n=128). The intervention group did not show any significant difference in development of pocket-hematomas compared to the control (p=0.24). Pain score was low in both groups (intervention NRS=1.41 vs. control NRS 1.32). Furthermore, no significant difference in pocket hematomas at follow-up were observed (p=0.77). Conclusion Using a compressive dressing did not significantly reduce bleeding or pocket hematomas after pacemaker or ICD implantation or replacement. Furthermore, no significant difference related to pain was observed. This study shows that patients who are not considered to be at elevated risk for bleeding or pocket-hematomas do not seem to benefit from a compressive dressing. Keywords Pacemaker, Implantable Cardioverter Defibrillator, Prophylactic compression bandaging, Pocket-hematoma, Device, Compression tool.

OBJECTIVES:This report discusses the challenges and strategies involved in managing venous stenosis secondary to pacing or defibrillator leads, focusing on endovascular treatment options and procedural considerations. KEY PROCEDURAL STEPS:Crucial steps of the procedure include thorough preprocedural planning, obtaining multisite venous access for optimal angiographic visualization, wiring through the stent using a percutaneous coronary intervention wire supported by a microcatheter and guiding catheter, confirming true lumen and intraluminal wire passage, and progressive ballooning using high-pressure balloons and kissing balloon technique. POTENTIAL PITFALLS:Procedural complications include crushing of the pacing leads within the stent, incomplete stent expansion, and aggravation of existing stenosis. Ensuring correct wire trajectory and using multiple imaging modalities are critical to avoiding these issues. TAKE-HOME MESSAGE:Venous stenosis related to pacing leads requires a multidisciplinary approach, with careful preprocedural planning and meticulous technique.

BACKGROUND:The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) investigated the efficacy and safety of the subcutaneous implantable cardioverter defibrillator (S-ICD) compared with a transvenous ICD (TV-ICD) and showed noninferiority of the S-ICD with regard to the composite end point of device-related complications and inappropriate shocks after 49.1 months. Complications associated with transvenous leads are expected to occur after longer follow-up. The PRAETORIAN-XL trial aims to investigate whether the S-ICD is superior to the TV-ICD with respect to device-related complications at 8-year follow-up. METHODS:The PRAETORIAN trial randomized patients with a class I or IIa indication for ICD therapy without the need for pacing to either S-ICD or TV-ICD among 39 centers in the United States and Europe between March 2011 and January 2017. The follow-up was extended after 49.1 months by an additional 4 years for the PRAETORIAN-XL trial. The primary end point was the composite of all device-related complications. Complications could be related or unrelated to the lead and minor or major, with major complications being those requiring an invasive intervention. End points were analyzed according to the modified intention-to-treat principle using a Fine-Gray subdistribution hazards model to account for competing risks. An as-treated analysis was performed using a Cox proportional hazards model with device type as time-dependent variable. RESULTS:Patients were randomized to S-ICD (n=426) and TV-ICD (n=423). Twenty-one percent of the S-ICD group versus 18% of the TV-ICD group were women. The median age at implantation was 63 (interquartile range, 54-69) years for the S-ICD and 64 (interquartile range, 56-69) years for the TV-ICD. After a median follow-up of 87.5 months, all device-related complications (major and minor combined) were not significantly different in the modified intention-to-treat analysis (subdistribution hazard ratio, 0.73 [95% CI, 0.48-1.12]); P=0.15). However, TV-ICD patients more often had a major complication or lead-related complication (P=0.03 and P<0.001, respectively). Moreover, the as-treated analysis showed significantly more complications in patients with a TV-ICD compared with an S-ICD (hazard ratio, 0.64 [95% CI, 0.41-0.99]; P=0.047). CONCLUSIONS:The PRAETORIAN-XL trial demonstrated that there was no significant difference between the S-ICD and TV-ICD in all device-related complications during long-term follow-up. However, the TV-ICD carries a higher risk of major and lead-related complications compared with S-ICD therapy. The S-ICD should therefore be considered for all patients without a pacing indication who are evaluated for ICD therapy. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.

BACKGROUND:The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to overcome the risk of lead-related complications associated with the transvenous implantable cardioverter-defibrillator (TV-ICD). In contrast to the TV-ICD, the S-ICD is a completely extrathoracic device. Subsequently, complications differ between these 2 implantable cardioverter-defibrillators, which might impact patient perceptions of the therapies. This prespecified secondary analysis of the PRAETORIAN trial evaluates differences in quality of life. METHODS:The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) randomized patients with an implantable cardioverter-defibrillator indication, without the need for pacing to S-ICD or TV-ICD therapy. Two questionnaires were collected at baseline, discharge, 12 months, and 30 months. The Duke Activity Status Index measures cardiac-specific physical functioning, and the 36-Item Short Form Health Survey measures physical and mental well-being, with the subscales bodily pain and mental health being of interest in this analysis. Mann-Whitney U tests were used to compare study arms, and a mixed model was used to describe the questionnaire outcomes over time. RESULTS:Patients were randomized to S-ICD (n=426) and TV-ICD (n=423). In the S-ICD group, 20% were women versus 19% in the TV-ICD group. The median age was 63 (interquartile range, 54-69) years in the S-ICD group versus 64 (interquartile range, 56-69) years in the TV-ICD group. There were no significant differences in the Duke Activity Status Index and 36-Item Short Form Health Survey subscales for bodily pain and mental health between the groups at any time point. Patients with a shock in the last 90 days had significantly lower scores for social functioning (P=0.008) and role limitations due to emotional problems (P=0.001) than patients without a shock, but this effect did not differ between treatment arms. CONCLUSIONS:In a large randomized cohort of patients with an S-ICD or TV-ICD, no difference in overall quality of life was observed. However, implantable cardioverter-defibrillator shocks resulted in a reduction in quality of life, regardless of the device type or appropriateness. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.

BACKGROUND:Inappropriate therapy (IAT) is an undesirable side effect of implantable cardiac defibrillator (ICD) therapy. Early studies with the subcutaneous ICD (S-ICD) showed relatively high inappropriate shock (IAS) rates. The PRAETORIAN (Prospective Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) trial demonstrated that the S-ICD is noninferior to the transvenous ICD (TV-ICD) with regard to the combined end point of IAS and complications. This secondary analyses evaluates all IAT in the PRAETORIAN trial. METHODS:This international, multicenter trial randomized 849 patients with an indication for ICD therapy between S-ICD (n=426) and TV-ICD therapy (n=423). ICD programming was mandated by protocol. All analysis were performed in the modified intention-to-treat population. RESULTS:In both groups 42 patients experienced IAT (48-month Kaplan-Meier estimated cumulative incidence, 9.9% and 10.1%, respectively; hazard ratio (HR), 0.99 [95% CI, 0.65-1.52]; P=0.97). There was no significant difference in patients experiencing IAS between both groups (P=0.14). In the S-ICD group, 81 IAT episodes with 124 IAS and 1 inappropriate antitachycardia pacing occurred versus 89 IAT episodes with 130 IAS and 124 inappropriate antitachycardia pacing in the TV-ICD group. IAT episodes were most frequently caused by supraventricular tachycardias in the TV-ICD group (n=83/89) versus cardiac oversensing in the S-ICD group (n=40/81). In the TV-ICD group, a baseline heart rate >80 bpm (HR, 1.99 [95% CI, 1.05-3.76]; P=0.03), a history of atrial fibrillation (HR, 2.66 [95% CI, 1.41-5.02]; P=0.003), and smoking (HR, 2.46 [95% CI, 1.31-4.09]; P=0.005) were independent predictors for IAT. A QRS duration >120 ms was an independent predictor for IAT caused by cardiac oversensing in the S-ICD group (HR, 3.13 [95% CI, 1.34-7.31]; P=0.008). Post-IAS interventions significantly reduced IAS recurrence in both groups (P=0.046). CONCLUSIONS:There was no significant difference in IAT and IAS rates between the S-ICD and TV-ICD in a conventional ICD population, but causes and predictors for IAT differed between the devices. After the first IAS, an intervention significantly reduced the recurrence rate of IAS. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.

Background Staphylococcus aureus bacteremia (SAB) is a high-risk condition associated with high morbidity and mortality. In the presence of cardiac implantable electronic devices (CIEDs), SAB may cause or clinically indicate device infection. We aimed to estimate the 10-year absolute risk of SAB in adult Danish first-time CIED carriers. Secondary aims included identification of risk factors associated with SAB.Methods A registry-based study utilizing Danish nationwide registers and including consecutive Danish patients undergoing first CIED implantation between 2000 and 2020 was conducted. The primary outcome was first-time SAB after CIED implantation.Results A total of 87 257 patients with first CIED implantation in the study period were identified (median age, 75 years; 62.6% were male; median follow-up, 3.8 years). Patients with pacemakers (PMs) were older and with more noncardiovascular comorbidities compared to patients with implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices with or without defibrillator capacity (CRTs). In total, 1366 patients (1.6%) developed SAB. The 10-year absolute risk (95% confidence interval) of SAB was 2.0% (1.9%-2.1%) for PM, 2.6% (2.2%-3.1%) for ICD, and 3.7% (3.0%-4.5%) for CRT. A multivariable Cox analysis identified hemodialysis (hazard ratio [HR], 8.51), SAB before CIED (HR, 2.76), liver disease (HR, 2.35), and carrying a CRT device (HR, 1.68) among the covariates associated with increased risk of SAB.Conclusions The absolute risk of SAB in Danish CIED carriers increased with more advanced CIED systems. The risk was highest within the first 3 months after CIED implantation and increased with the presence of certain covariates including renal dialysis, SAB before CIED, male sex, and advancing age. In a nationwide Danish cohort of first-time cardiac implantable electronic device recipients, the risk of Staphylococcus aureus bacteraemia increased with more advanced CIED-systems. The risk was highest within the first 3 months after device implantation. Graphical Abstract

Abstract Background According to current guidelines, complete removal of cardiac implantable electronic device (CIED) should be considered in patients with valvular infective endocarditis (IE), accounting for the identified pathogen and need for valve surgery (Class IIa recommendation). Unselected longitudinal data are needed to assess this strategy. Purpose To examine IE readmission after IE discharge according to status of CIED removal in patients with conservatively treated IE. Methods Using Danish nationwide registries, we identified patients aged ≥18 years with first-time IE from 2010-2021. We included patients with conservatively treated IE and a CIED, who were alive at IE discharge. Patients who underwent CIED removal during IE admission were compared to those without removal, examining the study outcome of IE readmission within six months after IE discharge. An initial blanking period of 14 days was applied after IE discharge. The Aalen-Johanson estimator and multivariable Cox regression models were used to determine cumulative incidences and adjusted hazard ratios (HRs) of IE readmission according to status of CIED removal, respectively. Results Among 6,843 patients with first-time IE, 5,731 (83.7%) were conservatively treated. Of these, 1,201 (21.0%) had a CIED, of which 205 (17.1%) died during IE admission. Thus, the final study population comprised 996 patients alive at IE discharge. The median age of the study population was 75.5 years (interquartile range [IQR]: 67.9-82.0), and 753 (75.6%) were males. In total, 574 (57.6%) patients underwent CIED removal during IE admission. Patients who underwent CIED removal were younger, compared to patients without CIED removal, 73.1 years (IQR: 65.7-79.1) versus 79.0 years (IQR: 71.3-85.1), respectively. The six-month cumulative incidence of IE readmission was 2.0% (95% confidence interval [CI]: 1.1-3.5%) in patients who underwent CIED removal versus 6.1% (95% CI: 4.0-8.9%) in patients without CIED removal (P-value=0.001) (Figure 1). CIED removal was associated with a significantly lower six-month rate of IE readmission, compared to no CIED removal (HR: 0.36 [95% CI: 0.17-0.77]). Relapse bacteraemia (including IE) with the same microorganism as first-time IE occurred in 2.2% of patients who underwent CIED removal and in 5.4% of patients without CIED removal. Staphylococcus aureus was the most common microorganism in 33.3% of patients with relapse bacteraemia who underwent CIED removal. Conclusions In this nationwide study, the six-month rate of infective endocarditis (IE) readmission was three-fold lower in patients who underwent cardiac implantable electronic device (CIED) removal, compared to patients without CIED removal. The current findings suggest that CIED removal is associated with lower risk of relapse of IE in patients with conservatively treated IE. These results are in line with current guideline recommendations. However, more randomized clinical trial data are needed.

Aims The decisions about placing an ICD in a child are more difficult than in an adult due to longer expected lifespan and the complication risk. Young patients gain the most years from ICDs, despite higher risk of device-related complications. The secondary prevention ICD indication is clear, and device is implanted regardless of potential complications. For primary prevention, risk of sudden cardiac death and complications need to be evaluated. We aimed to compare outcomes for primary and secondary prevention ICDs.Methods and results Retrospective nationwide cohort study including paediatric patients identified from the Danish ICD registry with ICD implanted at an age <= 15 from 1982-21. Demographics, complications (composite of device-related infections or lead-failure requiring re-operation, mortality because of arrhythmia, or unknown cause), and mortality were retrieved from medical charts. Endpoint was appropriate therapy (shock or anti-tachycardia pacing for ventricular tachycardia or fibrillation). Of 72 receiving an ICD, the majority had channelopathies (n = 34) or structural heart diseases (n = 28). ICDs were implanted in 23 patients for primary prevention and 49 for secondary prevention, at median ages of 13.8 and 11.6 years (P-value 0.01), respectively. Median follow-up was 9.0 (interquartile ranges: 4.7-13.5) years. The 10-year cumulative incidence of first appropriate therapy was 70%, with complication and inappropriate therapy rates at 41% and 15%, respectively. No difference was observed between prevention groups for all outcomes. Six patients died during follow-up.Conclusion In children, two-thirds are secondary prevention ICDs. Children have higher appropriate therapy and complication rates than adults, while the inappropriate therapy rate was low. Graphical Abstract

BACKGROUND AND AIM:There are a paucity of studies investigating workforce affiliation in connection with first-time implantable cardioverter defibrillator (ICD)-implantation. This study explored workforce affiliation and risk markers associated with not returning to work in patients with ICDs. METHODS:Using the nationwide Danish registers, patients with a first-time ICD-implantation between 2007 and 2017 and of working age (30-65 years) were identified. Descriptive statistic and logistic regression models were used to describe workforce affiliation and to estimate risk markers associated with not returning to work, respectively. All analyses were stratified by indication for implantation (primary and secondary prevention). RESULTS:Of the 4659 ICD-patients of working age, 3300 patients (71%) were members of the workforce (employed, on sick leave or unemployed) (primary: 1428 (43%); secondary:1872 (57%)). At baseline, 842 primary and 1477 secondary prevention ICD-patients were employed. Of those employed at baseline, 81% primary and 75% secondary prevention ICD-patients returned to work within 1 year, whereof more than 80% remained employed the following year. Among patients receiving sick leave benefits at baseline, 25% were employed after 1 year. Risk markers of not returning to work were 'younger age' in primary prevention ICD-patients, while 'female sex', left ventricular ejection fraction 'LVEF ≤40', 'lower income', and '≥3 comorbidities' were risk markers in secondary prevention ICD-patients. Lower educational level was a risk marker in both patient groups. CONCLUSION:High return-to-work proportions following ICD-implantation, with a subsequent high level of employment maintenance were found. Several significant risk markers of not returning to work were identified including 'lower educational level' that posed a risk in both patient groups. TRIAL REGISTRATION NUMBER:Capital Region of Denmark, P-2019-051.

Introduction: Pericardial effusion, a known complication to implantation of cardiac implantable electronic devices (CIED), may cause life-threatening cardiac tamponade. Limited knowledge is available about risk factors for clinically relevant procedural pericardial effusion. The aim is to identify the patient- and procedure-related risk factors associated with clinically relevant procedural pericardial effusion. Method: A nationwide observational cohort study based on data on 55 121 patients from the Danish Pacemaker Register between 2000 and 2018. We defined a clinically relevant procedural pericardial effusion related to the implantation if it occurred within 90 days after the primary CIED-procedure. Prespecified risk factors were analysed by multivariable logistic regression models to estimate the association with pericardial effusion. Results: There were 115 (0.21%) patients diagnosed with clinically relevant procedural pericardial effusion, with a median age of 75 years and 38.3% were females. Of these, 80.9% lead to a subsequent pericardiocentesis procedure. In adjusted logistic regression analysis, an increased risk of clinically relevant pericardial effusion was associated with female sex (OR:1.49 [95%CI: 1.03-2.16]), heart failure (OR:1.54 [95%CI: 1.06-2.23]), previous cardiac surgery (OR:1.63 [95%CI: 1.05-2.55]), CRT-device (OR:2.05 [95%CI: 1.23-3.41]), tertiary-centres (OR:1.8 [95%CI: 1.18-2.73]), increased procedural volume per year (>1000) (OR:1.85 [95%CI: 1.03-3.30]), indication of device-implantation (atrioventricular block) (OR:2.37 [95CI: 1.45-3.87]), and increasing number of leads implanted (two leads (OR:2.39 [95%CI: 1.43-4.00]), three leads (OR:4.77 [95%CI: 2.50-9.10])). Conclusion: Clinically relevant procedural pericardial effusion is a rare complication after CIED-implantation in Denmark. This study reveals important patient- and procedure-related risk factors associated with clinically relevant procedural pericardial effusion.

Abstract Aims Reduced psychological health is associated with adverse patient outcomes and higher mortality. We aimed to examine if a Brugada syndrome (BrS) diagnosis and symptomatic disease presentation were associated with an increased risk of new-onset depression or anxiety and all-cause mortality. Methods and results All Danish patients diagnosed with BrS (2006–2018) with no history of psychiatric disease and available for ≥6 months follow-up were identified using nationwide registries and followed for up to 5 years after diagnosis. The development of clinical depression or anxiety was evaluated using the prescription of medication and diagnosis codes. Factors associated with developing new-onset depression or anxiety were determined using a multivariate Cox proportional hazards regression model. Disease manifestation was categorized as symptomatic (aborted cardiac arrest, ventricular tachycardia, or syncope) or asymptomatic/unspecified at diagnosis. A total of 223 patients with BrS and no history of psychiatric disease were identified (72.6% male, median age at diagnosis 46 years, 45.3% symptomatic). Of these, 15.7% (35/223) developed new-onset depression or anxiety after BrS diagnosis (median follow-up 5.0 years). A greater proportion of symptomatic patients developed new-onset depression or anxiety compared with asymptomatic patients [21/101 (20.8%) and 14/122 (11.5%), respectively, P = 0.08]. Symptomatic disease presentation (HR 3.43, 1.46–8.05) and older age (lower vs. upper tertile: HR 4.41, 1.42–13.63) were significantly associated with new-onset depression or anxiety. All-cause mortality in this group of patients treated according to guidelines was low (n = 4, 1.8%); however, 3/4 developed depression or anxiety before death. Conclusion Approximately, one-sixth of patients with BrS developed new-onset depression or anxiety following a diagnosis of BrS. Symptomatic BrS disease manifestation was significantly associated with new-onset depression or anxiety.

Aim The COVID-19 pandemic resulted in a significant decrease in the number of hospital admissions for severe emergent cardiovascular diseases during lockdowns worldwide. This study aimed to determine the impact of both the first and the second Danish nationwide lockdown on the implantation rate of cardiac implantable electronic devices (CIEDs). Methods We retrospectively analysed the number of CIED implantations performed in Denmark and stratified them into 3-week intervals. Results The total number of de novo CIED implantations decreased during the first lockdown by 15.5% and during the second by 5.1%. Comparing each 3-week interval using rate ratios, a significant decrease in the daily rates of the total number of de novo and replacement CIEDs (0.82, 95% CI [0.70, 0.96]), de novo CIEDs only (0.82, 95% CI [0.69, 0.98]), and non-acute pacemaker implantations (0.80, 95% CI [0.63, 0.99]) was observed during the first interval of the first lockdown. During the second lockdown (third interval), a significant decrease was seen in the daily rates of de novo CIEDs (0.73, 95% CI [0.55, 0.97]), and of pacemakers in total during both the second (0.78, 95% CI [0.62, 0.97]) and the third (0.60, 95% CI [0.42, 0.85]) intervals. Additionally, the daily rates of acute pacemaker implantation decreased during the second interval (0.47, 95% CI [0.27, 0.79]) and of non-acute implantation during the third interval (0.57, 95% CI [0.38, 0.84]). A significant increase was observed in the number of replacement procedures during the first interval of the second lockdown (1.70, 95% CI [1.04, 2.85]). Conclusions Our study found only modest changes in CIED implantations in Denmark during two national lockdowns.

BACKGROUND:Changes in QRS duration (∆QRS) are often used in the clinical setting to evaluate the effect of cardiac resynchronization therapy (CRT), although an association between ∆QRS and outcomes is not firmly established. We aimed to assess the association between mortality and ∆QRS after CRT in patients from the DANISH (Danish Study to Assess the Efficacy of ICDs in Patients with Non-Ischemic Systolic Heart Failure on Mortality) study. METHODS:We included all patients from DANISH who received a CRT device and had available QRS duration data before and after implantation. Cox proportional hazards models were used to assess associations between ∆QRS (post-CRT QRS minus pre-CRT QRS) and mortality. RESULTS:Complete data were available in 572 patients. Median baseline QRS duration was 160 ms (IQR [146;180]). Post-CRT QRS was recorded a median of 48 days (IQR [33;86]) after implantation, and the median ∆QRS was -14 ms (IQR [-38;-3]). During a median follow-up of 4.1 years (IQR [2.5;5.8]), 106 patients died. In crude Cox regression, all-cause mortality was reduced by 6% per 10 ms shortening of QRS (HR 0.94; CI: 0.88-1.00, p = 0.04). The effect did not remain significant after multivariable adjustment (HR 1.01, CI: 0.93-1.10, p = 0.77). Further, no association was found between ∆QRS and improvement of New York Heart Association functional class at 6 months (OR 1.03, CI: 0.96-1.10, p = 0.42). CONCLUSION:In a large cohort of patients with non-ischemic cardiomyopathy, reduction of QRS duration after CRT was not associated with changes in mortality during long-term follow-up.

Objective: Identify implantable cardioverter defibrillator (ICD) patients at risk of distress (i.e., depression, anxiety, and ICD concerns) and associated risk factors. Method: First-time ICD patients (n = 1503) from the Danish national DEFIB-WOMEN study completed questionnaires at baseline, 3, 6, 12 and 24 months. Results: Of patients with low scores on distress, only 4%-7.2% experienced an increase in distress during 24 months of follow-up (FU), while 30.5%-52.5% with increased levels were likely to maintain increased levels at FU. Higher education, higher age, female sex, and good physical functioning at baseline were associated with less depression, anxiety and ICD concerns at FU. Previous psychological problems, smoking, Type D personality, NYHA class III-IV - all assessed at baseline - and shocks during FU were associated with depression, anxiety and ICD concerns. Conclusions: Generally, patients' psychological health improved, but patients with increased baseline scores were more likely to have increased scores at FU. We need to be vigilant if patients report elevated distress, particularly if they have depression at baseline, as depression seems more persistent. Given the impact of depression on health-related quality of life and prognosis, they should be screened and monitored closely.