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.

Anxiety and depression as risk factors for ICD shocks and mortality in patients with an implantable cardioverter defibrillator - A systematic review.

OBJECTIVE: To examine associations between baseline anxiety and depression and occurrence of ICD shocks and risk of mortality in patients with an implantable cardioverter defibrillator (ICD). METHOD: We systematically searched EMBASE, PubMed, PsycINFO, and CINAHL for eligible studies fulfilling the predefined criteria. RESULTS: We included 37 studies based on 25 different cohorts following 35,003 participants for up to seven years. We observed no association between baseline anxiety nor depression and the occurrence of ICD shocks. More than half of the identified studies (respectively 56% and 60%) indicated a significant association between baseline anxiety or depression and increased risk of mortality (anxiety: n = 5, ranging from Hazard ratios (HR):1.02 [Confidence intervals (CI) 95% 1.00-1.03] to HR:3.45 [CI 95% 1.57-7.60]; depression: n = 6, ranging from HR:1.03 [CI 95% 1.00-1.06] to HR:2.10 [CI 95% 1.44-3.05]). We found a significant association between high methodological quality of the primary study and the detection of a significant association (p < 0.01). CONCLUSIONS: Baseline anxiety and depression are associated with increased risk of mortality in patients with an ICD, but not with occurrence of ICD shocks. Inclusion of baseline anxiety and depression in risk stratification of mortality may be warranted.

Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator.

BACKGROUND: The extravascular implantable cardioverter-defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of transvenous ICDs. The safety and efficacy of extravascular ICDs are not yet known. METHODS: We conducted a prospective, single-group, nonrandomized, premarket global clinical study involving patients with a class I or IIa indication for an ICD, all of whom received an extravascular ICD system. The primary efficacy end point was successful defibrillation at implantation. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful defibrillation was greater than 88%. The primary safety end point was freedom from major system- or procedure-related complications at 6 months. The safety objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients free from such complications was greater than 79%. RESULTS: A total of 356 patients were enrolled, 316 of whom had an implantation attempt. Among the 302 patients in whom ventricular arrhythmia could be induced and who completed the defibrillation testing protocol, the percentage of patients with successful defibrillation was 98.7% (lower boundary of the one-sided 97.5% confidence interval [CI], 96.6%; P<0.001 for the comparison with the performance goal of 88%); 299 of 316 patients (94.6%) were discharged with a working ICD system. The Kaplan-Meier estimate of the percentage of patients free from major system- or procedure-related complications at 6 months was 92.6% (lower boundary of the one-sided 97.5% CI, 89.0%; P<0.001 for the comparison with the performance goal of 79%). No major intraprocedural complications were reported. At 6 months, 25 major complications were observed, in 23 of 316 patients (7.3%). The success rate of antitachycardia pacing, as assessed with generalized estimating equations, was 50.8% (95% CI, 23.3 to 77.8). A total of 29 patients received 118 inappropriate shocks for 81 arrhythmic episodes. Eight systems were explanted without extravascular ICD replacement over the 10.6-month mean follow-up period. CONCLUSIONS: In this prospective global study, we found that extravascular ICDs were implanted safely and were able to detect and terminate induced ventricular arrhythmias at the time of implantation. (Funded by Medtronic; ClinicalTrials.gov number, NCT04060680.).

Early ICD implantation in cardiac arrest survivors with acute coronary syndrome - predictors of implantation, ICD-therapy and long-term survival.

Objectives. Implantable cardioverter defibrillator (ICD) implantation in patients resuscitated from out-of-hospital cardiac arrest (OHCA) due to acute myocardial infarction (AMI) is controversial. Design. Consecutive OHCA-survivors due to AMI from two Danish tertiary heart centers from 2007 to 2011 were included. Predictors of ICD-implantation, ICD-therapy and long-term survival (5 years) were investigated. Patients with and without ICD-implantation during the index hospital admission were included (later described as early ICD-implantation). Patients with an ICD after hospital discharge were censored from further analyses at time of implantation. Results. We identified 1,457 consecutive OHCA-patients, and 292 (20%) of the cohort met the inclusion criteria. An ICD was implanted during hospital admission in 78 patients (27%). STEMI and successful revascularization were inversely and independently associated with ICD-implantation (ORSTEMI = 0.37, 95% CI: 0.14-0.94, ORrevasc = 0.11, 0.03-0.36) whereas age, sex, LVEF <35%, comorbidity burden or shockable first OHCA-rhythm were not associated with ICD-implantation. Appropriate ICD-shock therapy during the follow-up period was noted in 15% of patients (n = 12). Five-year mortality-rate was significantly lower in ICD-patients (18% vs. 28%, plogrank = 0.02), which was persistent after adjustment for prognostic factors (HR = 0.44 (95% CI: 0.23-0.88)). This association was no longer found when using first event (death or appropriate shock whatever came first) as outcome variable (plogrank = 0.9). Conclusions. Mortality after OHCA due to AMI was significantly lower in patients with early ICD-implantation after adjustment for prognostic factors. When using appropriate shock and death as events, ICD-patients had similar outcome as patients without an ICD, which may suggest a survival benefit due to appropriate device therapy.

Long-term outcomes in young patients with atrioventricular block of unknown aetiology.

AIMS: Atrioventricular block (AVB) of unknown aetiology is rare in the young, and outcome in these patients is unknown. We aimed to assess long-term morbidity and mortality in young patients with AVB of unknown aetiology. METHODS AND RESULTS: We identified all Danish patients younger than 50 years receiving a first pacemaker due to AVB between January 1996 and December 2015. By reviewing medical records, we included patients with AVB of unknown aetiology. A matched control cohort was established. Follow-up was performed using national registries. The primary outcome was a composite endpoint consisting of death, heart failure hospitalization, ventricular tachyarrhythmia, and cardiac arrest with successful resuscitation. We included 517 patients, and 5170 controls. Median age at first pacemaker implantation was 41.3 years [interquartile range (IQR) 32.7-46.2 years]. After a median follow-up of 9.8 years (IQR 5.7-14.5 years), the primary endpoint had occurred in 14.9% of patients and 3.2% of controls [hazard ratio (HR) 3.8; 95% confidence interval (CI) 2.9-5.1; P < 0.001]. Patients with persistent AVB at time of diagnosis had a higher risk of the primary endpoint (HR 10.6; 95% CI 5.7-20.0; P < 0.001), and risk was highest early in the follow-up period (HR 6.8; 95% CI 4.6-10.0; P < 0.001, during 0-5 years of follow-up). CONCLUSION: Atrioventricular block of unknown aetiology presenting before the age of 50 years and treated with pacemaker implantation was associated with a three- to four-fold higher rate of the composite endpoint of death or hospitalization for heart failure, ventricular tachyarrhythmia, or cardiac arrest with successful resuscitation. Patients with persistent AVB were at higher risk. These findings warrant improved follow-up strategies for young patients with AVB of unknown aetiology.

Anxiety, depression, ventricular arrhythmias and mortality in patients with an implantable cardioverter defibrillator: 7 years' follow-up of the MIDAS cohort.

OBJECTIVE: To examine whether anxiety and depression at time of implantation of an implantable cardioverter defibrillator (ICD) is associated with ventricular arrhythmias (VAs) and mortality 7 years later. METHODS: A cohort of 399 patients (80% men; mean (SD) age = 58.3 (12.2)) implanted with an ICD completed the Hospital Anxiety and Depression Scale (HADS) and the State-Trait Anxiety Inventory at time of implantation. Patients were followed up for VAs and mortality at 7 years. RESULTS: At 7-years follow-up, 34% of the patients had died and 38% had experienced VAs. Baseline depression (score ≥ 8) (HR:2.10; 95% CI:1.44-3.05, p < 0.001) was associated with 7-year mortality in adjusted analyses while state anxiety (score ≥ 40) (HR:1.45; 95% CI:1.02-2.06, p = 0.039) and trait anxiety (score ≥ 40) (HR:1.51; 95% CI:1.06-2.16, p = 0.022) showed a trend towards an association with mortality. No association was found between VAs and anxiety and depression. There was a dose-response relationship with higher burden of anxiety (HR:2.13; 95% CI:1.31-3.46, p = 0.002) and depression (HR:2.13; 95% CI:1.33-3.42, p = 0.002) measured with the HADS (scores < 8, 8-10 and > 10) being associated with an increased risk of mortality. CONCLUSION: Patients with depression had greater risk of mortality, whereas anxiety only showed a trend. Neither anxiety nor depression was associated with VAs during follow-up.

Aetiologies and temporal trends of atrioventricular block in young patients: a 20-year nationwide study.

AIMS: To describe aetiologies and temporal trends in young patients with atrioventricular block (AVB). METHODS AND RESULTS: We identified all patients in Denmark, receiving their first pacemaker because of AVB before the age of 50 years between 1996 and 2015. Medical records were reviewed and clinical information and diagnostic work-up results were obtained to evaluate the aetiology. We used Poisson regression testing for temporal trends. One thousand and twenty-seven patients were identified, median age at time of implantation was 38 (interquartile range 25-45) years, 584 (56.9%) were male. The aetiologies were complications to cardiac surgery [n = 157 (15.3%)], congenital AVB [n = 93 (9.0%)], cardioinhibitory reflex [n = 52 (5.0%)], congenital heart disease [n = 43 (4.2%)], complication to radiofrequency ablation [n = 35 (3.4%)], cardiomyopathy [n = 31 (3.0%)], endocarditis [n = 18 (1.7%)], muscular dystrophy [n = 14 (1.4%)], ischaemic heart disease [n = 14 (1.4%)], sarcoidosis [n = 11 (1.1%)], borreliosis [n = 9 (0.9%)], hereditary [n = 6 (0.6%)], side-effect to antiarrhythmics [n = 6 (0.6%)], planned His-ablation [n = 5 (0.5%)], complication to alcohol septal ablation [n = 5 (0.5%)], and other known aetiologies [n = 11 (1.1%)]. The aetiology remained unknown in 517 (50.3%) cases. While the number of patients with unknown aetiology increased during the study period (P < 0.001), we observed no significant change in the number of patients with identified aetiology (P = 0.35). CONCLUSION: In a nationwide cohort, the aetiology of AVB was identified in only half the patients younger than 50 years referred for first-time pacemaker implantation. The number of patients with unknown aetiology increased during the study period. These findings indicate need for better insight into aetiologies of AVB and improved diagnostic work-up guidelines.

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.

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 ].

A Comparison of the Quality of Life of Patients With an Entirely Subcutaneous Implantable Defibrillator System Versus a Transvenous System (from the EFFORTLESS S-ICD Quality of Life Substudy).

The first clinical results from the Evaluation of Factors Impacting Clinical Outcome and Cost Effectiveness of the subcutaneous implantable cardioverter defibrillator (EFFORTLESS S-ICD) Registry on the entirely S-ICD system are promising, but the impact of the S-ICD system on patients' quality of life (QoL) is not known. We evaluated the QoL of patients with an S-ICD against an unrelated cohort with a transvenous (TV)-ICD system during 6 months of follow-up. Consecutively implanted patients with an S-ICD system were matched with patients with a TV-ICD system on a priori selected variables including baseline QoL. QoL was measured with the Short-Form Health Survey at baseline, 3, and 6 months after implant and compared using multivariable modeling with repeated measures. Patients with an S-ICD (n = 167) versus a TV-ICD system (n = 167) did not differ significantly on physical (p = 0.8157) and mental QoL scores (p = 0.9080) across baseline, 3, and 6 months after implantation in adjusted analyses. The evolution in physical (p = 0.0503) and mental scores (p = 0.3772) during follow-up was similar for both cohorts, as indicated by the nonsignificant interaction effect for ICD system by time. Both patients with an S-ICD system and a TV-ICD system experienced significant improvements in physical and mental QoL between time of implant and 3 months (both p's <0.0001) and between time of implant and 6 months (both p's <0.0001) but not between 3 and 6 months (both p's >0.05). In conclusion, these first results show that the QoL of patients with an S-ICD versus TV-ICD system is similar and that patients with either system experience improvements in QoL on the short term.

Perioperative management of antithrombotic treatment during implantation or revision of cardiac implantable electronic devices: the European Snapshot Survey on Procedural Routines for Electronic Device Implantation (ESS-PREDI).

The European Snapshot Survey on Procedural Routines for Electronic Device Implantation (ESS-PREDI) was a prospective European survey of consecutive adults who had undergone implantation/surgical revision of a cardiac implantable electronic device (CIED) on chronic antithrombotic therapy (enrolment March-June 2015). The aim of the survey was to investigate perioperative treatment with oral anticoagulants and antiplatelets in CIED implantation or surgical revision and to determine the incidence of complications, including clinically significant pocket haematomas. Information on antithrombotic therapy before and after surgery and bleeding and thromboembolic complications occurring after the intervention was collected at first follow-up. The study population comprised 723 patients (66.7% men, 76.9% aged ≥66 years). Antithrombotic treatment was continued during surgery in 489 (67.6%) patients; 6 (0.8%) had their treatment definitively stopped; 46 (6.4%) were switched to another antithrombotic therapy. Heparin bridging was used in 55 out of 154 (35.8%) patients when interrupting vitamin K antagonist (VKA) treatment. Non-vitamin K oral anticoagulant (NOAC) treatment was interrupted in 88.7% of patients, with heparin bridging in 25.6%, but accounted for only 25.3% of the oral anticoagulants used. A total of 108 complications were observed in 98 patients. No intracranial haemorrhage or embolic events were observed. Chronic NOAC treatment before surgery was associated with lower rates of minor pocket haematoma (1.4%; P= 0.042) vs. dual antiplatelet therapy (13.0%), VKA (11.4%), VKA + antiplatelet (9.2%), or NOAC + antiplatelet (7.7%). Similar results were observed for bleeding complications (P= 0.028). Perioperative management of patients undergoing CIED implantation/surgical revision while on chronic antithrombotic therapy varies, with evidence of a disparity between guideline recommendations and practice patterns in Europe. Haemorrhagic complications were significantly less frequent in patients treated with NOACs. Despite this, the incidence of severe pocket haematomas was low.

Single-coil and dual-coil defibrillator leads and association with clinical outcomes in a complete Danish nationwide ICD cohort.

BACKGROUND: The best choice of defibrillator lead in patients with routine implantable cardioverter-defibrillator (ICD) is not settled. Traditionally, most physicians prefer dual-coil leads but the use of single-coil leads is increasing. OBJECTIVE: The purpose of this study was to compare clinical outcomes in patients with single- and dual-coil leads. METHODS: All 4769 Danish patients 18 years or older with first-time ICD implants from 2007 to 2011 were included from the Danish Pacemaker and ICD Register. Defibrillator leads were 38.9% single-coil leads and 61.1% dual-coil leads. The primary end point was all-cause mortality. Secondary end points were lowest successful energy at implant defibrillation testing, first shock failure in spontaneous arrhythmias, structural lead failure, and lead extraction outcomes. RESULTS: Single-coil leads were associated with lower all-cause mortality with an adjusted hazard ratio of 0.85 (95% confidence interval 0.73-0.99; P = .04). This finding was robust in a supplementary propensity score-matched analysis. However, dual-coil leads were used in patients with slightly higher preimplant morbidity, making residual confounding by indication the most likely explanation for the observed association between lead type and mortality. The lowest successful defibrillation energy was higher using single-coil leads (23.2 ± 4.3 J vs 22.1 ± 3.9 J; P < .001). No significant differences were observed for other secondary end points showing high shock efficacies and low rates of lead failures and extraction complications. CONCLUSION: Shock efficacy is high for modern ICD systems. The choice between single-coil and dual-coil defibrillator leads is unlikely to have a clinically significant impact on patient outcomes in routine ICD implants.

Inappropriate shocks in the subcutaneous ICD: Incidence, predictors and management.

BACKGROUND: The entirely subcutaneous implantable cardioverter-defibrillator (S-ICD) eliminates the need for transvenous leads, and therefore has the potential to improve lead-longevity and reduce lead-related complications. The S-ICD has a morphology-based sensing algorithm of which inappropriate shocks have been reported. METHODS: We analyzed the incidence, predictors and management of inappropriate shocks in the EFFORTLESS S-ICD Registry, which collects S-ICD implantation information and follow-up data from clinical centers in Europe and New Zealand. RESULTS: During a follow-up of 21 ± 13 months, 48 out of 581 S-ICD patients (71% male, age 49 ± 18 years) experienced 101 inappropriate shocks (8.3%). The most common cause was cardiac signal oversensing (73%), such as T-wave oversensing. Eighteen shocks (18%) were due to supraventricular tachycardias (SVT), of which 15 occurred in the shock-only zone. Cox-proportional hazard modeling using time-dependent covariates demonstrated that patients with a history of atrial fibrillation (HR 2.4) and patients with hypertrophic cardiomyopathy (HR 4.6) had an increased risk for inappropriate shocks, while programming the primary vector for sensing (from xyphoid to V6) reduced the risk. Reprogramming or optimization of SVT treatment after the first clinical event of inappropriate shock was successful in preventing further inappropriate shocks for cardiac oversensing and SVT events. CONCLUSIONS: Inappropriate shocks, mainly due to cardiac oversensing, occurred in 8.3% of the S-ICD patients. Patients with hypertrophic cardiomyopathy or a history of atrial fibrillation were at increased risk, warranting specific attention for sensing and programming in this population.

The patient perspective on the Riata defibrillator lead advisory: a Danish nationwide study.

BACKGROUND: The St Jude Medical Riata lead advisory was issued owing to insulation failures. The impact of this advisory on patients' well-being is unknown. OBJECTIVES: The objectives of this study were to describe the acute impact of the Riata advisory on patients' well-being and psychological functioning and to examine changes over time. METHODS: Patients with active Riata leads completed standardized and validated patient-reported outcomes (PROs) in connection with a nationwide fluoroscopic screening with 12-month follow-up. They were matched (1:1) on age, sex, and implant indication with nonadvisory controls for baseline comparisons. Cohen's effect size d was used to determine the clinical relevance of the estimated adjusted mean differences (small, d = 0.20; moderate, d = 0.50; large, d ≥ 0.80). RESULTS: Of all Riata patients, 86% (256 of 299) completed baseline PROs and 70% (210 of 299) follow-up PROs. Riata patients reported poorer device acceptance (d = -0.28; P = .001) and increased device-related concerns (d = 0.29; P < .001) as compared with matched nonadvisory controls. There were no differences in symptoms of depression (d = 0.13; P = .13). Female sex was an independent predictor of a high advisory impact on general well-being as assessed with a purpose-designed question (odds ratio 2.24; P = .04). Device-related concerns decreased over time (d = -0.17; P = .002), but no changes were seen for other PROs. CONCLUSION: The Riata advisory is associated with a persistent small reduction in device acceptance and a small increase in device-related concerns with minimal improvement over time. Female sex is a predictor of a high negative advisory impact on general well-being. A need for counseling may arise in vulnerable subsets of patients.

Prospective nationwide fluoroscopic and electrical longitudinal follow-up of recalled Riata defibrillator leads in Denmark.

BACKGROUND: Recalled St. Jude Medical Riata defibrillator leads are prone to insulation failures with externalized conductors (ECs). Longitudinal studies are needed to guide lead management. OBJECTIVE: The purpose of this study was to describe the dynamic nature of EC and the association with electrical abnormalities and lead extraction outcomes. METHODS: A nationwide cohort established in 2012 of 295 patients with recalled Riata leads with dwell time 5.1 ± 1.1 years, 34 ECs, and 19 electrical abnormalities were followed until death, lead discontinuation with fluoroscopy, or a new 2013 screening with fluoroscopy and device interrogation. RESULTS: Fluoroscopic follow-up of 239 patients with normal baseline fluoroscopy revealed incident overt EC in 8 leads and borderline EC in 2 leads after 1.1 ± 0.2 years, with an incidence rate of 3.7 per 100 person-years (95% confidence interval 2.0-6.9). Fluoroscopic follow-up in 27 patients with baseline EC showed an increase in EC length of 4 ± 1 mm (P <.001) after 1.1 ± 0.3 years. Electrical follow-up in 276 patients with normal baseline electrical function demonstrated 20 incident electrical abnormalities after 1.0 ± 0.3 years, with an incidence rate of 7.1 per 100 person-years (95% confidence interval 4.6-11.0). This rate was significantly higher in leads with baseline EC, with an adjusted incidence rate ratio of 4.4 (95% confidence interval 1.7-11.5, P = .002). In 15 extractions, all leads were removed, with 2 major complications. CONCLUSION: The development of EC is a dynamic process despite long lead dwell time. ECs are associated with a higher risk of electrical abnormalities. Therefore, lead replacement should be considered, especially in patients with a long life expectancy.

Nationwide fluoroscopic screening of recalled Riata defibrillator leads in Denmark.

BACKGROUND: The natural history of insulation defects with inside-out conductor externalization in recalled St Jude Medical Riata defibrillator leads is not well understood. OBJECTIVES: To determine the prevalence of externalization in a nationwide screening. Secondary aims were to examine time dependence and location of externalization, association with electrical failure, and fluoroscopic diagnostic performance. METHODS: All 299 patients with recalled Riata leads in Denmark were identified, and all except one underwent fluoroscopy and device interrogation. Externalizations were confirmed by multiple investigators. RESULTS: The prevalence of externalization was 32 of 298 (11%) at a mean dwell time of 5.1 years. The prevalence was 21 of 98 (21%) for 8-F leads and 11 of 200 (6%) for 7-F leads; however, 8-F leads had longer dwell times. The degree of externalization was correlated with dwell time (Spearman's ρ = .37; P = .03). Externalization more often included the lead segment below the tricuspid annulus in dual coil leads than in single coil leads (69% vs 16%; P = .004). No association was observed between externalization and electrical function. Fluoroscopic diagnostic performance was good with positive and negative predictive values of 88% and 99%, respectively. CONCLUSIONS: The prevalence of externalization in a nationwide screening is at the same level as reported in previous studies with similar lead dwell times. The degree of externalization is time dependent, and location seems to differ between single and dual coil leads. Long-term lead performance and association with electrical failure need further clarification. Fluoroscopy has a good diagnostic performance in clinical practice.

Waiting for a pacemaker: is it dangerous?

AIMS: To determine waiting period-related morbidity, mortality, and adverse events in acute patients waiting for a permanent pacemaker (PPM). METHODS AND RESULTS: A retrospective chart review of all PPM implantations in Region Zealand, Denmark, in 2009 was conducted. Patients were excluded if they were discharged from the hospital during the waiting period or referred from the outpatient department. Adverse events were tracked. Four hundred and eighty-seven PPM implantations were identified. Of these, 259 patients (53.2%) required acute PPM implantation and waited a mean of 5.1 days from PPM indication to implantation. A lack of implantation capacity was responsible for 4.5 of the waiting days. Twenty-nine patients (11.2%) developed infection while waiting, primarily urinary tract infections. Thirteen patients (5.0%) suffered non-sustained ventricular tachycardia, and eight patients (3.1%) suffered clinical cardiac arrest followed by successful resuscitation. Three patients (1.2%) died during the waiting period before successful implantation. Forty-eight patients (18.5%) received the sympathomimetic beta-adrenergic agent, isoprenaline, and seven patients (13.7%) had malignant arrhythmias or cardiac arrest, reaching statistical significance (P < 0.05). Twenty-eight patients (10.8%) had a temporary transvenous-pacing catheter applied acutely. CONCLUSIONS: The patients awaited acute PPM implantations for a mean of 4.5 days because of capacity problems. Overall, 83 patients (32.0%) experienced at least one adverse event during the waiting period. The present study indicates that a waiting period is dangerous as it is associated with an increased risk of adverse events. Acute PPMs should be implanted with a 24-h pacemaker implantation service capacity.

Patient-reported outcomes in Danish implantable cardioverter defibrillator patients with a Sprint Fidelis lead advisory notification.

AIMS: Few studies have investigated the association between implantable cardioverter defibrillators (ICDs) and lead advisory notifications and patient-reported outcomes (PROs). We examined (i) whether the mode used to inform patients about a device advisory is associated with PROs, and (ii) whether patients with a lead subject to a device advisory report poorer PROs than non-advisory controls. METHODS AND RESULTS: Patients (n= 207) implanted with an ICD at Aarhus University Hospital, Denmark, with a Sprint Fidelis lead subject to an advisory and a non-advisory control group (n= 510), completed a set of standardized PRO measures. A Bonferroni correction was applied to all statistical PRO comparisons to adjust for multiple comparisons, with a P-value of 0.0038 (0.05/13 PROs) indicating statistical significance. Device advisory patients did not differ significantly on PROs according to mode of notification (all P-values >0.0038). They also did not differ significantly from controls on mean scores of depression, anxiety, device acceptance, and health status (all P > 0.0038). Differences were only found on ICD concerns (P< 0.0001) and on mental health status (P = 0.003), with advisory patients reporting fewer ICD concerns and a better mental health status than non-advisory controls. CONCLUSIONS: The mode used to inform ICD patients about the advisory was not associated with PROs, nor was the overall well-being of device advisory patients impaired compared to non-advisory controls. These results indicate that ICD patients are generally able to cope with a device advisory.

Attitudes towards implantable cardioverter-defibrillator therapy: a national survey in Danish health-care professionals.

AIMS: The aim of this study was to examine health-care professionals attitudes towards implantable cardioverter-defibrillator (ICD) therapy and issues discussed with patients. METHODS AND RESULTS: Survey of 209 health-care professionals providing specialized treatment and care of ICD patients at the five implanting centres in Denmark. Questions pertained to gender, age, years of experience within the field, knowledge of the ongoing critical debate on ICD therapy, and personal experience with ICD treatment, and/or sudden cardiac arrest within family and/or friends. Of all participants, 185 (88.5%) completed the survey. Physicians spent less time informing patients about ICD treatment prior to implantation (mean min = 17.7 ± 11.2 vs. 28.6 ± 19.4; P < 0.001). They were more likely to discuss clinical issues but less likely to discuss psychosocial issues with patients compared with non-physicians. Physicians were less likely to believe that their personal attitude towards ICD treatment has no influence on how they deal professionally with patients (27.8 vs. 43.6%; P = 0.04). Physicians and non-physicians were equally positive towards ICD therapy as primary prophylaxis in ischaemic cardiomyopathy (87.6 vs. 82.1%; P = 0.40) but not in non-ischaemic cardiomyopathy (57.3 vs. 83.9%; P < 0.001). Physicians were more positive towards ICD therapy as secondary prophylaxis (98.9 vs. 84.2%; P = 0.001) compared with non-physicians. CONCLUSIONS: Physicians focus on clinical rather than psychosocial issues when discussing ICD treatment with candidate patients. At the same time, physicians are more aware that their attitude towards ICD treatment may influence how they deal professionally with patients compared with non-physicians.