Is interventional technique better than the traditional over-the-wire method for left ventricular lead implantation in cardiac resynchronization therapy?

Background: Interventional cardiac resynchronization therapy (I-CRT) for left ventricular lead (LVL) placement works as a supplement to traditional (over-the-wire) cardiac resynchronization therapy (T-CRT). It has been argued that I-CRT is a time-consuming and complicated procedure. Objective: The purpose of this study was to investigate differences in procedure-related, perioperative, postoperative, and clinical endpoints between I-CRT and T-CRT. Methods: This single-center, retrospective, cohort study included all consecutive patients receiving a CRT-pacemaker/defibrillator between January 1, 2012, and August 31, 2018. Patients underwent T-CRT from January 1, 2012, to June 1, 2015, and I-CRT from January 1, 2016, to August 31, 2018. We obtained data from patient record files, fluoroscopic images, and the Danish Pacemaker and ICD Register. Data were analyzed using Wilcoxon rank-sum/linear regression for continuous variables and the Pearson χ2/Fisher exact for categorical variables. Results: Optimal LVL placement was achieved in 82.7% of the I-CRT group and 76.8% of the T-CRT group (P = .015). In the I-CRT group, 99.0% of LVLs were quadripolar vs 55.3% in the T-CRT group (P <.001). Two or more leads were used during the procedure in 0.7% and 10.5% of all cases in the I-CRT and T-CRT groups, respectively (P <.001). Total implantation time was 81.0 minutes in the I-CRT group and 83.0 minutes in the T-CRT group (P = .41). Time with catheters in the coronary sinus was 45.0 minutes for the I-CRT group vs 37.0 minutes in the T-CRT group, respectively (P <.001). Conclusion: I-CRT did not prolong total implantation time despite longer time with catheters in the coronary sinus. I-CRT allowed more optimal LVL placement, wider use of quadripolar leads, and use of fewer leads during the procedure.

Influence of vitamin D receptor signaling and vitamin D on colonic epithelial cell fate decisions in ulcerative colitis.

BACKGROUND AND AIMS: Epidemiological studies have shown that subnormal levels of vitamin D (25(OH)D) are associated with a more aggravated clinical course of ulcerative colitis (UC). Despite an increased focus on the therapeutic importance of vitamin D and vitamin D receptor (VDR) signaling, the mechanisms underlying the effects of the vitamin D-VDR axis on UC remain elusive. Therefore, we aimed to investigate whether exposure to active vitamin D (1,25(OH)2D3)/VDR signaling in human organoids could influence the maintenance of the colonic epithelium. METHODS: Intestinal VDR expression was studied by immunohistochemistry, RNA expression arrays, and single-cell RNA sequencing of colonic biopsy specimens obtained from patients with UC and healthy individuals. To characterize the functional and transcriptional effects of 1,25(OH)2D3, we used patient-derived colonic organoids. The dependency of VDR was assessed by knocking out the receptor with CRISPR/Cas9. RESULTS: Our results suggest that 1,25(OH)2D3/VDR stimulation supports differentiation of the colonic epithelium and that impaired 1,25(OH)2D3/VDR signaling thereby may compromise the structure of the intestinal epithelial barrier, leading to flares of UC. Furthermore, a transcriptional response to VDR activity was observed primarily in fully differentiated cells at the top of the colonic crypt, and this response was reduced during flares of UC. CONCLUSIONS: We identified an important role of vitamin D signaling in supporting differentiated cell states in the human colonic epithelium, and thereby maintenance of the intestinal barrier integrity. This makes the vitamin D-VDR signaling axis an interesting target for therapeutic efforts to achieve and maintain remission in patients with UC.

Strategies to improve atrioventricular synchrony in patients with a Micra AV leadless pacemaker.

The second generation of transcatheter pacing systems, called Micra AV, can provide atrioventricular (AV) synchronous pacing via a new pacing algorithm relying on sensing mechanical atrial contraction. Several novel programming parameters were introduced to enable AV synchronous pacing, including an A3 window and A4 window as well as a conduction mode switch and an activity mode switch. In addition to several automated features, manual programming optimization of some of the novel parameters is key to improving AV synchrony. A solid knowledge of the features and their programming is essential for electrophysiologists implanting or following patients with Micra AV devices. Differences in programming optimization might partially explain the high variability of AV synchrony published in real-world data reports. This article reviews the key programming parameters of Micra AV. Subsequently, optimal programming recommendations for defined patient profiles are presented. Those were established by consensus within an expert panel comprised of 11 European electrophysiologists from high-volume Micra AV centres. The patient profiles were (1) high degree AV block and slow sinus rhythm; (2) high degree AV block and fast sinus rhythm; and (3) intermittent AV block. The panel recommended to evaluate the mechanical atrial activity on transthoracic echocardiography prior to implant. It was also agreed that Auto A3 Threshold and Tracking Check should be turned off in all patients, AV conduction mode switch should be turned off in all patients with high degree AV block, and the lower rate should be programmed to 50 bpm with exceptions based on individual clinical assessment. Future studies will be useful to evaluate the strength of those recommendations to improve the AV synchrony.

EFAS Score - Validation of Danish Version by the Score Committee of the European Foot and Ankle Society (EFAS).

BACKGROUND: The Score Committee of the European Foot and Ankle Society (EFAS) developed, validated, and published the EFAS Score in 13 languages. Currently, the Danish version completed data acquisition and underwent further validation. METHODS: The data were collected pre-operatively and post-operatively at a minimum follow-up of 3 months and mean follow-up of 6 months. Item reduction, scale exploration, confirmatory analyses and responsiveness were executed using classical test theory and item response theory. RESULTS: The internal consistency was confirmed in the Danish version (Cronbach's Alpha 0.88). The Standard Error of Measurement (SEM) was 0.31 and is similar to other language versions. Between baseline and follow-up, 77.2% of patients showed an improvement on their EFAS score, with adequate responsiveness (effect size 1.05). CONCLUSIONS: The Danish EFAS Score version was successfully validated in patients with a wide variety of foot and ankle pathologies. All score versions are freely available at www.efas.net.

Leadless pacemakers at 5-year follow-up: the Micra transcatheter pacing system post-approval registry.

BACKGROUND AND AIMS: Prior reports have demonstrated a favourable safety and efficacy profile of the Micra leadless pacemaker over mid-term follow-up; however, long-term outcomes in real-world clinical practice remain unknown. Updated performance of the Micra VR leadless pacemaker through five years from the worldwide post-approval registry (PAR) was assessed. METHODS: All Micra PAR patients undergoing implant attempts were included. Endpoints included system- or procedure-related major complications and system revision rate for any cause through 60 months post-implant. Rates were compared through 36 months post-implant to a reference dataset of 2667 transvenous pacemaker patients using Fine-Gray competing risk models. RESULTS: 1809 patients were enrolled between July 2015 and March 2018 and underwent implant attempts from 179 centres in 23 countries with a median follow-up period of 51.1 months (IQR: 21.6-64.2). The major complication rate at 60 months was 4.5% [95% confidence interval (CI): 3.6%-5.5%] and was 4.1% at 36 months, which was significantly lower than the 8.5% rate observed for transvenous systems (HR: .47, 95% CI: .36-.61; P < .001). The all-cause system revision rate at 60 months was 4.9% (95% CI: 3.9%-6.1%). System revisions among Micra patients were mostly for device upgrades (41.2%) or elevated thresholds (30.6%). There were no Micra removals due to infection noted over the duration of follow-up. At 36 months, the system revision rate was significantly lower with Micra vs. transvenous systems (3.2% vs. 6.6%, P < .001). CONCLUSIONS: Long-term outcomes with the Micra leadless pacemaker continue to demonstrate low rates of major complications and system revisions and an extremely low incidence of infection.

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.

An alternative NURF complex sustains acute myeloid leukemia by regulating the accessibility of insulator regions.

Efficient treatment of acute myeloid leukemia (AML) patients remains a challenge despite recent therapeutic advances. Here, using a CRISPRi screen targeting chromatin factors, we identified the nucleosome-remodeling factor (NURF) subunit BPTF as an essential regulator of AML cell survival. We demonstrate that BPTF forms an alternative NURF chromatin remodeling complex with SMARCA5 and BAP18, which regulates the accessibility of a large set of insulator regions in leukemic cells. This ensures efficient CTCF binding and boundary formation between topologically associated domains that is essential for maintaining the leukemic transcriptional programs. We also demonstrate that the well-studied PHD2-BROMO chromatin reader domains of BPTF, while contributing to complex recruitment to chromatin, are dispensable for leukemic cell growth. Taken together, our results uncover how the alternative NURF complex contributes to leukemia and provide a rationale for its targeting in AML.

Workforce affiliation in primary and secondary prevention Implantable Cardioverter Defibrillator patients - a nationwide Danish study.

BACKGROUND AND AIM: There are a paucity of studies investigating workforce affiliation in connection with first-time 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 2007-2017 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 4,659 ICD-patients of working age, 3,300 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 one-year, whereof more than 80% remained employed the following year. Among patients receiving sick leave benefits at baseline, 25% were employed after one-year. Risk markers of not returning to work were 'younger age' in primary prevention ICD-patients, while 'female sex', '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. CONCLUSIONS: 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.

Atrial pacing minimization in sinus node dysfunction and risk of incident atrial fibrillation: a randomized trial.

BACKGROUND AND AIMS: High percentages of atrial pacing have been associated with an increased risk of atrial fibrillation. This study is aimed at evaluating whether atrial pacing minimization in patients with sinus node dysfunction reduces the incidence of atrial fibrillation. METHODS: In a nationwide, randomized controlled trial, 540 patients with sinus node dysfunction and an indication for first pacemaker implantation were assigned to pacing programmed to a base rate of 60 bpm and rate-adaptive pacing (DDDR-60) or pacing programmed to a base rate of 40 bpm without rate-adaptive pacing (DDD-40). Patients were followed on remote monitoring for 2 years. The primary endpoint was time to first episode of atrial fibrillation longer than 6 min. Secondary endpoints included longer episodes of atrial fibrillation, and the safety endpoint comprised a composite of syncope or presyncope. RESULTS: The median percentage of atrial pacing was 1% in patients assigned to DDD-40 and 49% in patients assigned to DDDR-60. The primary endpoint occurred in 124 patients (46%) in each treatment group (hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.76-1.25, P = .83). There were no between-group differences in atrial fibrillation exceeding 6 or 24 h, persistent atrial fibrillation, or cardioversions for atrial fibrillation. The incidence of syncope or presyncope was higher in patients assigned to DDD-40 (HR 1.71, 95% CI 1.13-2.59, P = .01). CONCLUSIONS: Atrial pacing minimization in patients with sinus node dysfunction does not reduce the incidence of atrial fibrillation. Programming a base rate of 40 bpm without rate-adaptive pacing is associated with an increased risk of syncope or presyncope.

An organoid-based CRISPR-Cas9 screen for regulators of intestinal epithelial maturation and cell fate.

Generation of functionally mature organs requires exquisite control of transcriptional programs governing cell state transitions during development. Despite advances in understanding the behavior of adult intestinal stem cells and their progeny, the transcriptional regulators that control the emergence of the mature intestinal phenotype remain largely unknown. Using mouse fetal and adult small intestinal organoids, we uncover transcriptional differences between the fetal and adult state and identify rare adult-like cells present in fetal organoids. This suggests that fetal organoids have an inherent potential to mature, which is locked by a regulatory program. By implementing a CRISPR-Cas9 screen targeting transcriptional regulators expressed in fetal organoids, we establish Smarca4 and Smarcc1 as important factors safeguarding the immature progenitor state. Our approach demonstrates the utility of organoid models in the identification of factors regulating cell fate and state transitions during tissue maturation and reveals that SMARCA4 and SMARCC1 prevent precocious differentiation during intestinal development.

Cost-effectiveness of an antibacterial envelope for infection prevention in patients undergoing cardiac resynchronization therapy reoperations in Denmark.

AIMS: Use of an absorbable antibacterial envelope during implantation prevents cardiac implantable electronic device infections in patients with a moderate-to-high infection risk. Previous studies demonstrated that an envelope is cost-effective in high-risk patients within German, Italian, and English healthcare systems, but these analyses were based on limited data and may not be generalizable to other healthcare settings. METHODS AND RESULTS: A previously published decision-tree-based cost-effectiveness model was used to compare the costs per quality-adjusted life year (QALY) associated with adjunctive use of an antibacterial envelope for infection prevention compared to standard-of-care intravenous antibiotics. The model was adapted using data from a Danish observational two-centre cohort study that investigated infection-risk patients undergoing cardiac resynchronization therapy (CRT) reoperations with and without an antibacterial envelope (n = 1943). We assumed a cost-effectiveness threshold of €34 125/QALY gained, based on the upper threshold used by the National Institute for Health and Care Excellence (£30 000). An antibacterial envelope was associated with an incremental cost-effectiveness ratio (ICER) of €12 022 per QALY in patients undergoing CRT reoperations, thus indicating that the envelope is cost-effective when compared with standard of care. A separate analysis stratified by device type showed ICERS of €6227 (CRT defibrillator) and €29 177 (CRT pacemaker) per QALY gained. CONCLUSIONS: Cost-effectiveness ratios were favourable for patients undergoing CRT reoperations in the Danish healthcare system, and thus are in line with previous studies. Results from this study can contribute to making the technology available to Danish patients and align preventive efforts in the pacemaker and ICD area.

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.

Severity of Brugada syndrome disease manifestation and risk of new-onset depression or anxiety: a Danish nationwide study.

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.

Does targeted positioning of the left ventricular pacing lead towards the latest local electrical activation in cardiac resynchronization therapy reduce the incidence of death or hospitalization for heart failure?

BACKGROUND: Cardiac resynchronization therapy (CRT) improves symptoms, health-related quality of life and long-term survival in patients with systolic heart failure (HF) and shortens QRS duration. However, up to one third of patients attain no measurable clinical benefit from CRT. An important determinant of clinical response is optimal choice in left ventricular (LV) pacing site. Observational data have shown that achieving an LV lead position at a site of late electrical activation is associated with better clinical and echocardiographic outcomes compared to standard placement, but mapping-guided LV lead placement towards the site of latest electrical activation has never been investigated in a randomized controlled trial (RCT). The purpose of this study was to evaluate the effect of targeted positioning of the LV lead towards the latest electrically activated area. We hypothesize that this strategy is superior to standard LV lead placement. METHODS: The DANISH-CRT trial is a national, double-blinded RCT (ClinicalTrials.gov NCT03280862). A total of 1,000 patients referred for a de novo CRT implantation or an upgrade to CRT from right ventricular pacing will be randomized 1:1 to receive conventional LV lead positioning preferably in a nonapical posterolateral branch of the coronary sinus (CS) (control group) or targeted positioning of the LV lead to the CS branch with the latest local electrical LV activation (intervention group). In the intervention group, late activation will be determined using electrical mapping of the CS. The primary endpoint is a composite of death and nonplanned HF hospitalization. Patients are followed for a minimum of 2 years and until 264 primary endpoints occurred. Analyses will be conducted according to the intention-to-treat principle. Enrollment for this trial began in March 2018, and per April 2023, a total of 823 patients have been included. Enrollment is expected to be complete by mid-2024. CONCLUSIONS: The DANISH-CRT trial will clarify whether mapping-guided positioning of the LV lead according to the latest local electrical activation in the CS is beneficial for patients in terms of reducing the composite endpoint of death or nonplanned hospitalization for heart failure. Results from this trial are expected to impact future guidelines on CRT. GOV IDENTIFIER: NCT03280862.

A web-based intervention for patients with an implantable cardioverter defibrillator - A qualitative study of nurses' experiences (Data from the ACQUIRE-ICD study).

Objective: The aim of this study was to explore cardiac nurses' experiences with a comprehensive web-based intervention for patients with an implantable cardioverter defibrillator. Methods: We conducted an explorative qualitative study based on individual semi-structured interviews with 9 cardiac nurses from 5 Danish university hospitals. Results: We found one overall theme: "Between traditional nursing and modern eHealth". This theme was derived from the following six categories: (1) comprehensive content in the intervention, (2) patient-related differences in engagement, (3) following the protocol is a balancing act, (4) online communication challenges patient contact, (5) professional collaboration varies, and (6) an intervention with potential. Cardiac nurses were positive towards the web-based intervention and believe it holds a large potential. However, they felt challenged by not having in-person and face-to-face contact with patients, which they found valuable for assessing patients' wellbeing and psychological distress. Conclusion: Specific training in eHealth communication seems necessary as web-based care entails a shift in the nursing role and requires a different way of communication.InnovationFocusing on the user experience in web-based care from the perspective of cardiac nurses is innovative, and by applying implementation science this leads to new knowledge to consider when developing and implementing web-based care.

Use of Nonrecommended Drugs in Patients With Brugada Syndrome: A Danish Nationwide Cohort Study.

Background Patients with Brugada syndrome (BrS) are recommended to avoid drugs that may increase their risk of arrhythmic events. We examined treatment with such drugs in patients with BrS after their diagnosis. Methods and Results All Danish patients diagnosed with BrS (2006-2018) with >12 months of follow-up were identified from nationwide registries. Nonrecommended BrS drugs were grouped into drugs to "avoid" or "preferably avoid" according to http://www.brugadadrugs.org. Cox proportional hazards analyses were performed to identify factors associated with any nonrecommended BrS drug use, and logistic regression analyses were performed to examine associated risk of appropriate implantable cardioverter defibrillator therapy, mortality, and a combined end point indicating an arrhythmic event of delayed implantable cardioverter defibrillator implantation, appropriate implantable cardioverter defibrillator therapy, and mortality. During a median follow-up of 6.8 years, 93/270 (34.4%) patients with BrS (70.4% male, median age at diagnosis 46.1 years [interquartile range, 32.6-57.4]) were treated with ≥1 nonrecommended BrS drugs. No difference in any nonrecommended BrS drug use was identified comparing time before BrS diagnosis (12.6%) with each of the 5 years following BrS diagnosis (P>0.05). Factors associated with any nonrecommended BrS drug use after diagnosis were female sex (hazard ratio [HR]) 1.83 [95% CI, 1.15-2.90]), psychiatric disease (HR, 3.63 [1.89-6.99]), and prior use of any nonrecommended BrS drug (HR, 4.76 [2.45-9.25]). No significant association between any nonrecommended BrS drug use and implantable cardioverter defibrillator therapy (n=20/97, odds ratio [OR], 0.7 [0.2-2.4]), mortality (n=10/270, OR, 3.4 [0.7-19.6]), or the combined end point (n=38/270, OR, 1.7 [0.8-3.7]) was identified. Conclusions One in 3 patients with BrS were treated with a nonrecommended BrS drug after BrS diagnosis, and a BrS diagnosis did not change prescription patterns. More awareness of nonrecommended drug use among patients with BrS is needed.

Long-term risk of cardiovascular implantable electronic device reinterventions following external cardioversion of atrial fibrillation and flutter: A nationwide cohort study.

BACKGROUND: External cardioversion (ECV) is an essential part of rhythm control of atrial fibrillation and flutter in patients with and without cardiovascular implantable electronic devices (CIEDs). Long-term follow-up data on ECV-related CIED dysfunctions are limited. OBJECTIVE: The purpose of this study was to investigate the risk of CIED reintervention following ECV in a nationwide cohort. METHODS: We identified CIED implants and surgical reinterventions from 2005 to 2021 in the Danish Pacemaker and ICD Register. We included CIED patients undergoing ECV from 2010 to 2019 from the Danish National Patient Registry. For each ECV-exposed generator, 5 matched generators without ECV were identified, and for each ECV-exposed lead, 3 matched leads were identified. The primary endpoints were generator replacement and lead reintervention. RESULTS: We compared 2582 ECV-exposed patients with 12,910 matched patients with a pacemaker (47%), implantable cardioverter-defibrillator (ICD) (29%), cardiac resynchronization therapy-pacemaker (6%), or cardiac resynchronization therapy-defibrillator (18%). During 2 years of follow-up, 210 ECV-exposed generators (8.1%) vs 670 matched generators (5.2%) underwent replacements, and 247 ECV-exposed leads (5.6%) vs 306 matched leads (2.3%) underwent reintervention. Unadjusted hazard ratios were 1.61 (95% confidence interval [CI] 1.37-1.91; P <.001) for generator replacement and 2.39 (95% CI 2.01-2.85; P <.001) for lead reintervention. One-year relative risks were 1.73 (95% CI 1.41-2.12; P <.001) for generator replacement and 2.85 (95% CI 2.32-3.51; P <.001) for lead reintervention, and 2-year relative risks were 1.39 (95% CI 1.19-1.63; P <.001) and 2.18 (95% CI 1.84-2.57; P <.001), respectively. CONCLUSION: ECV in patients with a CIED is associated with a higher risk of generator replacement and lead reintervention. The risks of reinterventions were more pronounced within the first year after cardioversion.

Patients with an implantable cardioverter defibrillator at risk of poorer psychological health during 24 months of follow-up (results from the Danish national DEFIB-WOMEN study).

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.

Cardiac surgery in patients with cardiac implantable electronic devices and risk of device infections: a nationwide nested case-control study.

PURPOSE: Cardiac surgery in patients with cardiac implantable electronic devices (CIEDs) has been associated with a higher risk of infective endocarditis, but how it influences risk of CIED-specific infections is not known. Our aim was to examine risk of systemic CIED infections after cardiac surgery in patients with CIEDs. METHODS: Based on data obtained from Danish administrative registries and the Danish Pacemaker and ICD Register, we conducted a case-control study nested within a nationwide cohort of patients who underwent a de novo CIED implantation in Denmark between 1998 and 2017. We defined cases as incident systemic CIED infections resulting in device system extraction. Controls were sampled 1:100 on time, age, sex and device type using risk set sampling. Exposure was defined as coronary artery bypass graft, or cardiac heart valve replacement or repair surgery. RESULTS: From a study cohort comprising 67,621 patients, we identified 170 cases and 16,788 controls. In the minimally adjusted model, the incidence rate ratio (IRR) for systemic CIED infection was 6.4 (95% confidence interval (CI) 3.8-10.7) with cardiac surgery, and after additional confounder adjustment, 5.4 (95% CI 3.2-9.2). IRRs were higher with restriction to heart valve replacement surgery (adjusted IRR 7.5, 95% CI 4.0-16.6), and when limiting our exposure time window to one year (adjusted IRR 10.1, 95% CI 4.5-22.3). CONCLUSION: Cardiac surgery in patients with de novo CIEDs was associated with a high risk of systemic CIED infections. Highest risk was observed after heart valve replacement surgery and within the first year of surgery.