Edoxaban therapy increases treatment satisfaction and reduces utilization of healthcare resources: an analysis from the EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of atrial fibrillation (ENSURE-AF) study.

Aims: The EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of atrial fibrillation (ENSURE-AF) (NCT02072434) study was a multicentre prospective, randomized, open-label, blinded-endpoint evaluation (PROBE) trial comparing edoxaban with enoxaparin/warfarin followed by warfarin alone in 2199 non-valvular atrial fibrillation patients undergoing electrical cardioversion and showed comparable rates of bleeding and thromboembolism between treatments. This prespecified ancillary analysis investigated the impact of edoxaban therapy on treatment satisfaction and utilization of healthcare services. Methods and results: The Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) was completed by study patients on Day 28 post-cardioversion. Higher scores represent greater satisfaction. Healthcare resource utilizations were collected from randomization to Day 28 post-cardioversion. Data from patients who received at least one dose of study drugs were analysed. Patients treated with edoxaban were more satisfied than enoxaparin/warfarin in both PACT-Q treatment satisfaction and convenience scores (P < 0.001 for both). Differences in treatment satisfaction scores were greater in patients who underwent non-transoesophageal echocardiography (TOE)-guided cardioversion than in patients who underwent TOE-guided cardioversion. Edoxaban was associated with fewer clinic visits (4.75 visits vs. 7.60 visits; P < 0.001) and fewer hospital days (3.43 days vs. 5.41 days; P < 0.05). Rates of hospitalizations and emergency room visits were not significantly different. Overall, edoxaban therapy was estimated to reduce healthcare costs by €107.73, €437.92, €336.75, and $246.32 per patient in German, Spanish, Italian, and US settings, respectively. Conclusions: The convenience of edoxaban therapy over warfarin in patients undergoing cardioversion may provide greater treatment satisfaction and cost savings to the healthcare system.

Disease progression after ablation for atrial flutter compared with atrial fibrillation: A nationwide cohort study.

AIMS: The aim of this study was to study the risk of death and development of arrhythmia and/or subsequently heart failure after an atrial flutter ablation procedure compared with an atrial fibrillation (AF) ablation procedure. METHODS: This observational study is based on data from Danish nationwide health databases. Patients with a first-time ablation procedure for either atrial flutter or AF in the period 2000-2016 were included. Rates of renewed arrhythmia, heart failure or death were compared and reported as adjusted hazard ratios (HR). RESULTS: The study population consisted of 2,004 and 3,803 patients with an incident atrial flutter or AF ablation procedure, respectively. All-cause mortality among atrial flutter patients was significantly higher compared with the AF group (HR 1.80, 95% confidence interval [CI] 1.39-2.35). The incidence of renewed arrhythmia without heart failure was lower in atrial flutter (HR 0.76, 95% CI 0.69-0.84). Renewed atrial flutter ablation and pacemaker implantations were significantly more frequent (HR 2.42, 95% CI 2.02-2.91 and HR 1.42, 95% CI 1.13-1.79, respectively) in atrial flutter compared with AF. The risk of heart failure was higher for atrial flutter, both after the initial ablation (HR 1.48, 95% CI 1.08-2.03), and after a further arrhythmia management event (HR 1.98, 95% CI 1.33-2.94). CONCLUSION: There was a higher mortality risk after atrial flutter ablation procedures compared with patients undergoing AF ablation. Rates of heart failure and further renewed (non-AF) arrhythmia management were higher in atrial flutter.

Death and thrombo-embolic risk after ablation of atrial flutter compared with atrial fibrillation: a nationwide cohort study.

AIMS: The aim of this study was to investigate whether there is a similar mortality and thrombo-embolic risk, after an atrial ablation procedure, compared with an atrial fibrillation (AF) procedure. METHODS AND RESULTS: Using data from nationwide Danish health registries, we identified patients aged 18-75 years undergoing a first-time atrial flutter or an AF ablation procedure in the period 2000-13. Cox proportional hazards regression was used to calculate hazard ratios (HRs) after 5 years of follow-up, adjusting for concomitant risk factors. A total of 1096 and 2266 patients underwent an ablation for atrial flutter or AF, respectively. Age distribution was similar in the two, but atrial flutter patients had more co-morbidities. During 5 years of follow-up, we observed 38 and 36 deaths in the atrial flutter and AF groups, corresponding to an almost two-fold higher mortality rate among atrial flutter patients [crude HR 1.92, 95% confidence interval (CI) 1.22-3.03]. The higher mortality rate persisted after adjustment for age, sex, diabetes mellitus, and hypertension (adjusted HR 1.68, 95% CI 1.05-2.69). The rate of thrombo-embolic events was similar in the two groups (crude HR 1.34, 95% CI 0.71-2.56; adjusted HR 1.22, 95% CI 0.62-2.41). CONCLUSION: In this observational study, patients with atrial flutter had a significantly higher all-cause mortality rate compared with those with AF after an ablation procedure, but similar thrombo-embolic event rates. Future studies should elucidate the reason for this difference in mortality.

Venous thromboembolism in patients with implantable cardioverter-defibrillators.

AIMS: To examine the incidence of venous thromboembolism (VTE) and its risk factors among patients with implantable cardioverter-defibrillators (ICDs). METHODS AND RESULTS: All first-time ICD recipients in Denmark during 2000-12 were identified from medical databases. Incident VTEs were ascertained, overall and according to gender, age, Charlson Comorbidity Index score (no, moderate, or severe comorbidity), prior pacemaker or cardiac resynchronization therapy (CRT-D) implantation, and ICD type (single-chamber, dual-chamber, or CRT-D). We computed the risk of VTE within 3 months and 5 years of implantation, taking death into account as a competing risk. We used Cox proportional hazards regression to compute hazard ratios as estimates of incidence rate ratios (IRRs). Among 8132 ICD recipients, 136 VTEs were diagnosed during up to 13 years of follow-up (median = 3.0 years). The VTE incidence rate was thus 4.5 per 1000 person-years [95% confidence interval (CI): 3.7-5.2]. Venous thromboembolism risk was 0.3% (95% CIs ranging from 0.1 to 0.7%) within 3 months following ICD implantation regardless of comorbidity level. Within 5 years following implantation it was 1.4% (95% CI: 0.8-2.3%), 1.3% (1.0-1.8%), and 3.2% (95% CI: 2.4-4.1%) for patients with no, moderate, and severe comorbidity, respectively. Overall, severe comorbidity conferred a 2.7-fold higher incidence rate ratio than no comorbidity (95% CI: 1.6-4.6). Incidence rate ratios did not differ by gender, age, or ICD type. CONCLUSION: Three-month risk of VTE following ICD implantation was 0.3% regardless of comorbidity level. Five-year risk of VTE following ICD implantation was 1.9% and more than twice as high for patients with severe comorbidity as for patients without comorbidity.

Regional differences in referral, procedures, and outcome after ablation for atrial fibrillation in Europe: a report from the Atrial Fibrillation Ablation Pilot Registry of the European Society of Cardiology.

AIMS: Ablation is an effective treatment of symptomatic and drug refractory atrial fibrillation (AF). Using data from the European AF Ablation Pilot Registry comprising 1410 patients from 10 European countries, we prospectively investigated regional differences in AF ablation regarding patient selection, ablation strategy, and outcome. METHODS AND RESULTS: Countries were divided into three regions: South (Greece, Italy, Spain), East (Czech Republic, Poland), and West/North (Belgium, Denmark, France, Germany, and the Netherlands). One-year success was defined as patient survival free from atrial arrhythmia, with or without antiarrhythmic drugs (AAD). In all regions, patients were symptomatic and treated extensively with beta-blockers and AAD pre-ablation. Patients in East had more co-morbidity, increased thromboembolic risk, were more likely to have paroxysmal AF, and they underwent more left atrial linear ablations. Adverse events remained within expected levels, albeit with a significantly higher reporting of adverse cardiovascular events in the West/North (4.7 vs. 1.4 and 1.5% in South and East, P = 0.0032). There was no significant difference in peripheral/vascular, neurological, pulmonary, gastrointestinal, or general adverse events. The 1-year success rate after ablation differed non-statistically between regions ranging from 69.1 to 74.7%. A second ablation was performed in 23.2% in West/North compared with 10.5 and 16.5% in South and East. The proportion of patients still on AADs was highest in the South region (51.6 vs. 42.3 and 38.8% in East and West/North). CONCLUSION: This study with all-comer patients shows that patient selection for ablation follows current guidelines but reveals significant differences regarding co-morbidity, medication, and ablation strategy. Despite this, 1-year outcomes are without significant differences and in line with previously published clinical trials.

New strict left bundle branch block criteria reflect left ventricular activation differences.

AIMS: Pacing lead electrical delays and strict left bundle branch block (LBBB) criteria were assessed against cardiac resynchronization therapy (CRT) outcome. METHODS: Forty-nine patients with LBBB and QRS duration >130 milliseconds underwent CRT-implantation. Sensed right ventricular to left ventricular electrical delay (RV-LV-IED) was measured. Response to CRT was defined as ≥15% decrease in left ventricular end-systolic volume. RESULTS: Eighteen of 20 (90%) patients with non-ischemic dilated cardiomyopathy (DCM) and 18 of 29 (62%) with ischemic heart disease (IHD) responded to CRT, p<0.01. When applying new strict ECG criteria subsequent rates of response in DCM were 18/19 (95%) and in IHD of 18/23 (78%) respectively, p<0.05 between IHD groups. Correspondingly, RV-LV-IED was longer in DCM compared to IHD patients and in responders compared to non-responders, p=0.017 and p<0.001, respectively. CONCLUSION: Interventricular electrical delay predicts left ventricular remodeling after CRT and new, strict ECG criteria of LBBB are superior in predicting remodeling.

Long pacing pulses reduce phrenic nerve stimulation in left ventricular pacing.

INTRODUCTION: Phrenic nerve stimulation is a major obstacle in cardiac resynchronization therapy (CRT). Activation characteristics of the heart and phrenic nerve are different with higher chronaxie for the heart. Therefore, longer pulse durations could be beneficial in preventing phrenic nerve stimulation during CRT due to a decreased threshold for the heart compared with the phrenic nerve. We investigated if long pulse durations decreased left ventricular (LV) thresholds relatively to phrenic nerve thresholds in humans. METHODS AND RESULTS: Eleven patients, with indication for CRT and phrenic nerve stimulation at the intended pacing site, underwent determination of thresholds for the heart and phrenic nerve at different pulse durations (0.3-2.9 milliseconds). The resulting strength duration curves were analyzed by determining chronaxie and rheobase. Comparisons for those parameters were made between the heart and phrenic nerve, and between the models of Weiss and Lapicque as well. In 9 of 11 cases, the thresholds decreased faster for the LV than for the phrenic nerve with increasing pulse duration. In 3 cases, the thresholds changed from unfavorable for LV stimulation to more than a factor 2 in favor of the LV. The greatest change occurred for pulse durations up to 1.5 milliseconds. The chronaxie of the heart was significantly higher than the chronaxie of the phrenic nerve (0.47 milliseconds vs. 0.22 milliseconds [P = 0.029, Lapicque] and 0.79 milliseconds vs. 0.27 milliseconds [P = 0.033, Weiss]). CONCLUSION: Long pulse durations lead to a decreased threshold of the heart relatively to the phrenic nerve and may prevent stimulation of the phrenic nerve in a clinical setting.

Does atrial pacing lead to atrial fibrillation in patients with sick sinus syndrome? Insights from the DANPACE trial.

AIMS: Paroxysmal atrial fibrillation (AF) is common in patients with sick-sinus syndrome (SSS) and pacemakers leading to morbidity and an increased risk of stroke or death. Previous studies indicate that atrial pacing may precipitate AF. We investigated the relation between atrial pacing and the occurrence of AF during long-term follow-up among patients with SSS, no prior AF, and dual-chamber pacemakers (DDDRs). METHODS AND RESULTS: We analysed data from 396 patients who received DDDR pacemakers in the DANPACE trial. The percentage of atrial pacing (%AP) was compared with the number of mode-switch (MS) episodes collected by the pacemaker at each follow-up as an indicator of AF. Mean follow-up was 4.2 ± 2.4 years. The mean proportion of atrial and ventricular pacing was 59 ± 31 and 65 ± 33%, respectively. Approximately 72% developed AF as indicated by MS episodes at some point during follow-up. Unadjusted regression analysis indicated a relation between %AP and AF (P = 0.04), but after adjustment for possible confounders (sex, age, hypertension, diabetes, myocardial infarction, PQ interval, and left atrial diameter) there was no significant relationship (P = 0.37). CONCLUSION: Atrial fibrillation is very common among patients with SSS. No association between %AP and development of AF was found in patients with SSS. Future trials may randomize patients to different levels of AP exposure.

Health economic evaluation of single-lead atrial pacing vs. dual-chamber pacing in sick sinus syndrome.

AIMS: The recent Danish Multicentre Randomized Trial on Single-Lead Atrial (AAIR) Pacing versus Dual-Chamber (DDDR) Pacing in Sick Sinus Syndrome (DANPACE) suggested DDDR pacing as standard care. However, previous findings supported the routine use of AAIR pacing. This study investigated the cost-effectiveness of DDDR pacing compared with AAIR pacing for sick sinus syndrome. METHODS AND RESULTS: A decision-analytical model based on patient-level data from three randomized trials was designed from the Danish healthcare system's perspective. The main outcomes were lifetime costs, quality-adjusted lifeyears (QALYs), and net monetary benefit. Quality-adjusted lifeyears were calculated by utilizing community-based preferences. Costs were calculated by utilizing the extensive data on resource consumption, from the DANPACE trial. Data were pooled and adjusted for baseline differences. Dual-chamber pacing was shown to be cost-effective in all the analyses using a willingness-to-pay (WTP) threshold of £20,000/QALY, and most analyses using a WTP of £30,000/QALY. When pooling the data and adjusting for baseline differences, Monte Carlo simulations revealed a 51-71% probability of DDDR pacing being cost-effective at a WTP of £20,000/QALY, and a 42-58% probability at a WTP of £30,000/QALY. Dual-chamber pacing was most likely to be cost-effective among elderly patients with comorbidity. The expected value of perfect information was low and initiation of additional publicly funded Danish trials was discouraged. CONCLUSION: Dual-chamber pacing is likely to be a cost-effective treatment for sick sinus syndrome patients.

Groin hematoma after electrophysiological procedures-incidence and predisposing factors.

OBJECTIVES: We evaluated the incidence and predisposing factors of groin hematomas after electrophysiological (EP) procedures. DESIGN: Prospective, observational study, enrolling consecutive patients after EP procedures (Atrial fibrillation: n = 151; Supraventricular tachycardia/Diagnostic EP: n = 82; Ventricular tachycardia: n = 18). Patients underwent manual compression for 10 min and 3 h post procedural bed rest. AF ablations were performed with INR 2-3, ACT > 300, and no protamine sulfate. Adhesive pressure dressings (APDs) were used if sheath size ≥ 10F; procedural time > 120 min; and BMI > 30. Patient-reported hematomas were recorded by a telephone follow-up after 2 weeks. RESULTS: Hematoma developed immediately in 26 patients (10%) and after 14 days significant hematoma was reported in 68 patients (27%). Regression analysis on sex, age, BMI 25, ACT 300, use of APD, sheath size and number, and complicated venous access was not associated with hematoma, either immediately after the procedure or after 14 days. Any hematoma presenting immediately after procedures was associated with patient-reported hematomas after 14 days, odds ratio 18.7 (CI 95%: 5.00-69.8; P < 0.001). CONCLUSIONS: Any hematoma immediately after EP procedures was the sole predictor of patient-reported hematoma after 2 weeks. Initiatives to prevent groin hematoma should focus on the procedure itself as well as post-procedural care.

The impact of drug discontinuation in patients treated with temporary pacemaker due to atrioventricular block.

INTRODUCTION: Patients treated with a temporary pacemaker (TPM) due to atrioventricular (AV) block are often monitored after discontinuation of AV node blocking drugs to evaluate the indication for permanent pacing. However, the impact of drug discontinuation is sparsely documented. We investigated to what extent drug discontinuation abolished the need for permanent pacemaker (PPM) implantation. METHODS AND RESULTS: All hospital records of patients who received a TPM at Aalborg Hospital, Denmark, between January 2000 and March 2011 (n = 575) were retrospectively reviewed. Patients with AV block who were treated with a TPM and concomitant cessation of drug therapy were included if there was no other underlying mechanism causing the AV block. AV blocking drugs included antiarrhythmic agents classes II-IV and digoxin. Fifty-five patients fulfilled our inclusion criteria. Forty-seven patients had an indication for a PPM at the initial hospital admission, despite drug discontinuation. Of the remaining 8 patients who were discharged without a PPM, 3 subsequently experienced events: 2 had recurrence of AV block requiring a PPM, and 1 experienced syncope. Thus, in total, 49 (89%) patients had a final indication for a permanent pacemaker (PPM). Of patients receiving beta-blocker monotherapy, 26 (96%) had an indication for a PPM. TPM implantation was complicated by infection or displacement in 11% of cases. CONCLUSIONS: The vast majority of patients treated with a TPM due to AV block and who receive beta-blockers alone or in combination with digoxin have a final indication for a PPM despite cessation of drug treatment. TPM are frequently associated with complications.

Implanted cardiac devices are reliably detected by commercially available metal detectors.

OBJECTIVE: Explosions of Cardiovascular Implantable Electronic Devices (CIEDs) (pacemakers, defibrillators, and loop recorders) are a well-recognized problem during cremation, due to lithium-iodine batteries. In addition, burial of the deceased with a CIED can present a potential risk for environmental contamination. Therefore, detection of CIEDs in the deceased would be of value. This study evaluated a commercially available metal detector for detecting CIEDs. DESIGN: Observational study including pacemaker patients (n = 70) and a control group without pacemaker (n = 95). The investigational device was a hand-held metal detector for detecting metal or electricity wiring. RESULTS: The metal detector detected the pacemaker in all pacemaker patients and thus exhibited a sensitivity of 100%. The specificity of the metal detector was 86%, and the negative predictive value was 100%. Thirteen individuals without pacemakers were falsely identified as having an implanted device due to implanted prosthetic material or elements of clothing. CONCLUSION: A simple hand-held metal detector may detect CIEDs with a high sensitivity. It may be of value in detecting CIEDs in deceased persons before burial or cremation. Any signal detected by the metal detector should prompt further investigation of the body and patient files.

Heart failure in patients with sick sinus syndrome treated with single lead atrial or dual-chamber pacing: no association with pacing mode or right ventricular pacing site.

AIMS: Previous studies indicate that ventricular pacing may precipitate heart failure (HF). We investigated occurrence of HF during long-term follow-up among patients with sick sinus syndrome (SSS) randomized to AAIR or DDDR pacing. Furthermore, we investigated effects of percentage of ventricular pacing (%VP) and pacing site in the ventricle. METHODS AND RESULTS: We analysed data from 1415 patients randomized to AAIR (n = 707) or DDDR pacing (n = 708). Ventricular pacing leads were recorded as located in either an apical or a non-apical position. The %VP and HF hospitalizations were recorded during follow-up. Patients were classified with new HF, if in New York Heart Association (NYHA) functional class IV or if presence of ≥2 of: oedema; dyspnoea; NYHA functional class III. Mean follow-up was 5.4 ± 2.4 years. Heart failure hospitalizations did not differ between groups. In the AAIR group, 170 of the 707 (26%) patients developed HF vs. 169 of the 708 (26%) patients in the DDDR group, hazard rate ratio (HR) 1.00, 95% confidence interval (CI) 0.79-1.22, P = 0.87. In DDDR patients, 146 of the 512 patients (29%) with ventricular leads in an apical position developed HF vs. 28 of the 161 patients (17%) with the leads in a non-apical position, HR 0.67, CI 0.45-1.00, P = 0.05. After adjustments this difference was non-significant. The incidence of HF was not associated with %VP (P = 0.57). CONCLUSION: In patients with SSS, HF was not associated with pacing mode, %VP, or ventricular lead localization. This suggests that DDDR pacing is safe in patients with SSS without precipitating HF.

A third troponin T blood sample is not cost-effective in patients with suspected non-ST segment elevation acute coronary syndrome.

BACKGROUND: The diagnosis of acute myocardial infarction requires troponin assessment in at least two blood samples 6-9 hours apart, with an optional third sample 12-24 hours after admission if suspicion is high. Yet, in many institutions, this third sample is routinely drawn. This study aimed to evaluate cost-effectiveness of this third sample of troponin. METHODS: A total of 534 patients with possible Non ST-Elevation Acute Coronary Syndrome (NSTE-ACS) were included. Blood samples for cardiac TroponinT (cTnT) were obtained on arrival, after 6-9 hours, and 12-24 hours after admission. The costs of cTnT analysis, and hospital stay were calculated. RESULTS: Of the 534 patients, 124 had at least one elevated cTnT value. Among these, four patients (3.2%) had cTnT values increased only in the third sample. Based on their risk profile and/or ECG changes, these four patients were eligible for referral to coronary angiography even before the result of the third sample became available. The number of patients whose length of stay was extended solely because of the third sample was 275. Incremental cost of the third blood sample: [534 patients × Euro (EUR) 12 per cTnT analysis] + [275 patients × 0.5 day × EUR 1,550] = EUR 219,533. Approximately 1400 patients with suspected NSTE-ACS are admitted to our department each year. Thus, the total cost per year is: (1,400/534) × EUR 219,533 = EUR 575,555. CONCLUSION: A third troponin sample adds no vital information regarding patients' treatment or investigations plan. On the contrary, it may lead to an unnecessary extension of the admission period and increased costs.

Determinants of the release pattern of ischaemia-modified albumin in acute ST-elevation myocardial infarction treated with primary PCI.

BACKGROUND: Ischaemia-modified albumin (IMA) is proposed as a marker of cardiac ischaemia. Release kinetics of IMA have not been investigated during ongoing acute coronary syndrome. We evaluated IMA kinetics in patients with ongoing ST-segment elevation MI (STEMI) and revascularization by primary percutaneous coronary intervention (pPCI) as a model. METHODS: Twenty-five patients with STEMI undergoing successful pPCI (Age: median 65 y, range 41-79 y; symptoms duration: median 4 h, range 1-7 h). Fourteen blood samples were collected (11 during the first 24 h following pPCI) and analyzed for IMA, cardiac troponin T, CKMBmass, myoglobin, and heart-type fatty acid binding protein. RESULTS: Following pPCI, mean IMA increased to 16% above baseline, normalizing within less than 3 h. At the time of pPCI, patients with TIMI 0 flow in the infarct artery had low levels of IMA and only exhibited a rise in IMA levels after pPCI, whereas patients with TIMI 1-3 flow had high IMA levels on arrival with a subsequent decrease (p < 0.036). There was no statistically significant association between IMA and other variables, e.g. ECG, symptoms duration, sex, age, blood pressure, and number of vessels affected. Relative concentrations of IMA were low compared with other cardiac biomarkers. CONCLUSIONS: Our results indicate that IMA release may depend on reperfusion-induced events rather than ischaemia per se. Further, we find a narrow diagnostic time window and a low sensitivity of the IMA assay. Improved understanding of the release mechanisms of IMA is needed before clinical application of the test.

Diagnostic value of ischemia-modified albumin in patients with suspected acute coronary syndrome.

INTRODUCTION: Ischemia-modified albumin (IMA) has been proposed as a useful rule-out marker for the diagnosis of acute coronary syndrome (ACS) in the emergency department. This study evaluated the ability of IMA to predict the acute myocardial infarction (AMI) diagnosis in a population of chest pain patients. METHODS: The study population comprised 107 subjects (men, 62%; women, 38%) admitted with suspected ACS. None of the patients had ST-segment elevations that qualified for immediate revascularization. Ischemia-modified albumin was determined from serum with albumin cobalt binding test (Inverness Medical Innovations Inc, Stirling, UK). Furthermore, cardiac troponin T, creatinine kinase MB mass, myoglobin, and heart-type fatty acid binding protein (H-FABP) were determined on arrival, after 6 to 9 hours, and after 12 to 24 hours. All patients had at least 2 blood samples taken to exclude/verify the AMI. AMI was defined by a cardiac troponin T level greater than 0.03 microg/L. RESULTS: Thirty-three percent of the patients (n = 35) had a final diagnosis of AMI. The sensitivity of admission IMA for a final diagnosis of ACS was 0.86 (95% confidence interval [95% CI], 0.69-0.95). Specificity was 0.49 (95% CI, 0.36-0.60). Negative predictive value was 0.88 (95% CI, 0.72-0.95). The optimal cutoff threshold derived from the receiver operating characteristics (ROC) curve (ROC analysis) was determined as 91 U/mL. The area under the ROC curve was 0.73. Ischemia-modified albumin did not, at any time, provide superior sensitivity or specificity compared with other biomarkers. We do not find the data supportive of IMA as a standard marker in the emergency department.

Edoxaban versus warfarin in vitamin K antagonist experienced and naïve patients from the edoxaban versus warfarin in subjects undergoing cardioversion of atrial fibrillation (ENSURE-AF) randomised trial.

BACKGROUND: In ENSURE-AF study, edoxaban had similar efficacy and safety profile versus enoxaparin-warfarin (enox-warf) in patients undergoing electrical cardioversion of non-valvular atrial fibrillation. OBJECTIVES: To evaluate the efficacy and safety of edoxaban versus enox-warf in patients who were vitamin K antagonists (VKA) naïve or experienced at time of randomisation into ENSURE-AF trial. METHODS: The primary efficacy endpoint was a composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular death during the overall study period, 28 days on study drug after cardioversion and 30 days follow-up. The primary safety endpoint was the composite of major and clinically relevant nonmajor bleeding during the on-medication period from time of first dose to last dose of study drug taken + 3 days. RESULTS: Of 2199 patients enrolled in ENSURE-AF, 1095 were randomised to edoxaban and 1104 to enox-warf. There were numerically fewer primary efficacy endpoint events with edoxaban than enox-warf irrespective of whether VKA experienced or naïve (0.5% vs. 0.9%, 0.3% vs. 1.4%, respectively). There were no significant differences in the primary safety endpoint [odds ratio (OR) 2.09, 95% confidence interval (CI) 0.72-6.81 in anticoagulant experienced patients, OR 0.77, 95% CI 0.15-3.60 in anticoagulant naïve patients] and in major bleeding rates regardless of treatment or VKA experience (OR 0.69, 95%CI 0.06-6.04, OR 0.48, 95% CI 0.01-9.25, respectively). CONCLUSIONS: Edoxaban had comparable efficacy and safety to optimized anticoagulation with enox-warf. The primary efficacy and safety endpoint outcomes were broadly similar between VKA experienced or naïve patients.

Single and dual coil shock efficacy and predictors of shock failure in patients with modern implantable cardioverter defibrillators-a single-center paired randomized study.

PURPOSE: Implantable cardioverter defibrillators (ICDs) can treat life-threatening tachyarrhythmia with high-voltage shocks. The aims were to compare the efficacy of single and dual coil shock vectors in modern ICDs and to identify predictors of shock failure. METHODS: This is a single-center paired randomized study including 216 patients with mixed indications and ICDs from four manufacturers. All patients underwent two implant defibrillation tests using single and dual coil vectors with the test order randomized. Tested shock energy differed slightly between manufacturers because of differences in device programmability: first shock approximately 15 J below maximal output-if failed, second shock approximately 10 J below maximal output-if failed, third shock at maximal output. RESULTS: First shock success rate was 399/432 (92.4%). Comparing single and dual coil vectors, no differences were seen in first shock efficacy (91.7% vs. 93.1%, P = 0.629) or lowest tested succesfully stored energy (27.2 J vs. 27.1 J, P = 0.620). All successive internal shocks failed in 4/432 (0.9%) of inductions requiring external rescue shocks to restore circulation. Multivariate predictors of first shock failure were QRS duration (relative risk 0.81 per 10 ms, P = 0.001), amiodarone treatment (relative risk 3.30, P = 0.003), and body height (relative risk 1.70 per 10 cm, P = 0.019). CONCLUSIONS: Implant defibrillation testing of modern intravenous ICD systems demonstrates high shock efficacy with no difference between single and dual coil vectors.

Significant regional variation in use of implantable cardioverter-defibrillators in Denmark.

AIMS: Implantable cardioverter-defibrillator (ICD) treatment prevents sudden cardiac death in high-risk patients. This study examined geographical variation in ICD implantation rates in Denmark and potential causes of variation. METHODS AND RESULTS: We obtained numbers of ICD implantations in the 5 Danish regions and 98 municipalities during 2007-13 from the Danish Pacemaker and ICD Registry. Standardized implantation rates (SIRs) were computed as ICD implantations per 1 000 000 person-years, and age- and gender-standardized to the Danish population. We examined associations of the municipal SIR with mean age and Charlson Comorbidity Index score of ICD recipients, percentage of implantations with primary prophylactic indication, and distance from patient residency to ICD implanting centre. Based on 7192 ICD implantations, the nationwide SIR was 186 [95% confidence interval (CI) 182-190], ranging from 170 (95% CI 158-183) in the North Denmark Region to 206 (95% CI 195-218) in the Region of Zealand. Municipalities with higher patient comorbidity scores, higher percentages of implantations with primary prophylactic indication, and shorter distances to ICD implanting centres, had higher SIRs [differences between SIRs of municipalities in highest and lowest quartiles 22 (95% CI 10-34), 45 (95% CI 33-58), and 35 (95% CI 24-47), respectively]. Regional differences in SIRs decreased over time and had become insignificant during 2011-13. CONCLUSION: Implantable cardioverter-defibrillator implantation rates in Denmark varied significantly between regions but variation decreased during 2007-13. Geographical variation was associated with differences in patient comorbidity score, variation in use of primary prophylactic ICD treatment, and distance to ICD implanting centre.