Abstract Background It is debated whether insulin use is associated with a pro-arrhythmic effect. There is paucity of studies investigating this aspect in patients with heart failure (HF), where use of insulin is associated with an increased mortality risk. Purpose We aimed to investigate whether patients receiving insulin had higher risk of device-treated ventricular tachyarrhythmia (VTA) in a population of HF patients with medically treated diabetes and primary prevention implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy with defibrillator (CRT-D). Methods Information on ICD/CRT-D implantation and therapy, comorbidities, diabetes, diabetes-related complications and medication were obtained through Danish nationwide registers. From 2007 through 2016 we identified all primary prevention ICD/CRT-D implantations in HF patients with diabetes, defined as treatment with antidiabetic medication within one year prior to implantation. Patients were divided into two groups; Insulin treated vs. non-insulin treated patients. Endpoints of interest were VTA, defined as appropriate ICD therapy, and all-cause mortality. Cumulative incidence curves and adjusted Cox proportional Hazards regression analyses were used to assess risk of outcomes. Adjustment variables included age, gender, ischemic heart disease (IHD), left ventricular ejection fraction (LVEF), ICD vs. CRT-D, diuretic use (as a proxy for severity of HF), prior VTA and diabetes-related complications, identified from diagnosis codes for diabetic nephro-, retino-, and neuropathy, multiple diabetic complications and unspecified diabetic complications. Results We identified 1240 patients with HF and diabetes with a primary prevention ICD/CRT-D. The majority of patients had type 2 diabetes (94%). Of these 479 patients (39%) were treated with insulin and 761 (61%) were not. Patients were primarily male (85%) with mean age of 66.9±8.3 years, mean LVEF of 25.6±7.5%, 42% had CRT-D and 58% ICD, without differences between the groups. The insulin-treated group had a higher occurrence of diabetes-related complications (81% vs. 42%, p<0.01) and IHD (95% vs. 90%, p<0.01). During a mean follow-up of 3.1±2.1 years, 74 insulin treated patients (16%) and 86 non-insulin treated patients (11%) experienced VTA (p=0.034), with higher 5-year cumulative incidence of VTA in the insulin group. Insulin treatment was associated with significantly increased risk of VTA (HR = 1.45; 95% CI [1.04–2.03], p=0.031) and all-cause mortality (HR=1.27; 95% CI [1.03–1.58], p=0.027), as compared with non-insulin treated patients. Figure 1 Conclusion In HF patients with diabetes implanted with a primary prevention ICD/CRT-D, treatment with insulin was associated with a significant 45% increased risk of device-treated ventricular tachyarrhythmias and 27% increased risk of all-cause mortality. These findings support further clinical trials to evaluate the safety of insulin in patients with HF and type 2 diabetes.
Purpose: CRT does not always produce the desired clinical outcome due to problematic CS access, lead placement / dislodgement, phrenic nerve stimulation, chronic reliability lead issues, worsening heart failure or high risk ICD / pacemaker upgrades. Endocardial pacing for CRT is an alternative. The Wireless Stimulation of the Endocardium System (WiSE) comprises a battery-powered ultrasonic transmitter implanted in a left intercostal space and a leadless pacing electrode fixed directly onto the LV endocardium, replacing the CS lead. The WiSE System was evaluated in the multicentre SELECT-LV study. Method: WiSE was implanted in 34 pts indicated for CRT, but untreated due to various difficulties. 25 pts were followed for 12m. Primary and secondary endpoints were evaluated at 1 and 6m. Summary of results: Baseline characteristics: 25 male; NYHA 2.7 ± 0.6; age 65.8 ± 8.6 yrs; BMI 29.7 ± 4.8; intrinsic and RV paced QRSs were 163 ± 32 ms and 180 ± 30 ms respectively; EF 27.4 ± 5.4%; etiology ICM-10 / NICM-12 / both-3. By 12m, there were 2 deaths, 1 acute MI, 5 episodes of cardiac decompensation in 4 pts, and a resolved CVA in 1 pt who had failed to follow the post-op anticoagulation regimen. There were no instances of cardiac perforation or LV electrode dislodgement. Mean implant duration was 571 ± 136 days. Consistent CRT was achieved in 100%, 97% and 96% of pts at 1, 6 and 12m. BiV QRS durations were 129 ± 22, 129 ± 13 and 124 ± 17 ms at 1, 6 and 12m respectively. Reductions in BiV QRS duration compared with the baseline QRS for pts reaching 12m were 34 ± 27, 34 ± 28 and 39 ± 40 ms at 1, 6 and 12m respectively. The 6m clinical composite scores for these pts were 84% improved, 12% unchanged and 4% worsened. Conclusion: Wireless endocardial LV pacing is an alternative approach to CRT. These 12m data demonstrate the clinical benefit to our pts, previously untreated by CRT. BiV pacing is maintained with reverse electrical remodeling continuing to be evident 12m post implant.
Objective A patient-focused approach is advocated to embody risk of non-adherence to medication and subsequent adverse clinical outcomes following ischaemic heart disease (IHD). This study aimed to explore how patient perceived information on pharmacological prevention was associated with subsequent non-adherence to medication (measured by non-initiation, non-implementation and non-persistence) in patients with incident IHD. Design Cohort study. Setting Denmark. Participants Register-based cohort of 829 patients with incident IHD in 2013. Measures Perception covered whether patients’ experienced being adequately informed about their pharmacological prevention. Information on such was obtained from a survey and divided into ‘Well informed’, ‘Moderately informed’ and ‘Poorly informed’. Information on baseline characteristics, and reimbursed prescriptions of medication (antiplatelets, statins, ACE-inhibitors/angiotensin receptor blockers and β-blockers) during follow-up were obtained by linkage to nationwide public registers. Non-initiation and non-implementation of medication, measured as proportion of days covered, were analysed by Poisson regression. Non-persistence to medication, measured as risk of discontinuation, was analysed by multivariable Cox proportional hazard regression. Primary and secondary outcome measures Non-implementation and non-persistence to medication up to 365 days of follow-up were primary outcomes. Secondary outcomes included non-initiation as well as non-implementation and non-persistence to medication at 180 days of follow-up. Results A dose–response association was in general found between perception of pharmacological prevention and risk of non-implementation and non-persistence. For example, the hazard of non-persistence to antiplatelets was 1.18 (95% CI 0.71 to 1.96) times higher for patients reporting 'Moderately informed' and 1.89 (95% CI 1.10 to 3.25) times higher for patients reporting 'Poorly informed', compared with patients reporting 'Well informed of perception of pharmacological prevention' up to 365 days of follow-up. Conclusion Lower levels of perception of pharmacological prevention were associated with subsequent non-implementation and non-persistence to medication in patients with incident IHD.
Schizophrenia is associated with poor anticoagulation control and clinical prognosis in patients with atrial fibrillation (AF). Little is known about initiation of oral anticoagulation therapy (OAC) in this patient population.In the nationwide Danish health registries, we identified all patients with incident AF and schizophrenia with indication for OAC treatment. Patients with schizophrenia (n = 673) were matched 1:5 on sex, age, stroke risk score, and calendar-period to incident AF patients without schizophrenia. We calculated absolute risk and risk difference (RD) of OAC initiation, adjusting for stroke and bleeding risk factors. Analyses were stratified by calendar period (2000-2011 and 2012-2018) to account for changes after the introduction of non-vitamin K OACs (NOAC).Among patients with schizophrenia (mean age 69.5 years, 50.3% females), 33.7% initiated OAC within the first year after AF diagnosis, compared with 54.4% of patients without schizophrenia, corresponding to an adjusted RD of -20.7 (95% confidence interval [CI]: -24.7 to -16.7). OAC initiation increased over time regardless of schizophrenia status. During 2000-2011, 18.3% of patients with schizophrenia and 42.9% without schizophrenia initiated OAC (adjusted RD -23.6%, 95% CI -28.8 to -18.6). During 2012-2018, this was 48.5% and 65.7%, respectively (adjusted RD -14.4%, 95% CI -20.4 to -8.4).Initiation of OAC was substantially lower among patients with AF and schizophrenia compared with matched AF peers. These findings accentuate the importance of close attention to disparities in initiation of OAC treatment, and potential missed opportunities for prevention of disabling strokes in AF patients with schizophrenia.
Objective: We investigated the long-term cardiovascular outcomes associated with direct oral anticoagulants (DOACs), antiplatelets and No-Treatment compared to warfarin beyond 90-days after atrial fibrillation (AF) catheter ablation. Methods: We identified 12,010 AF patients undergoing first-time ablation in Denmark (2002-2018) and analyzed stroke, serious bleeding, cardiovascular death and the composite of these three endpoints (MACE) by incidence rates (IR) per 1000 person-years and Cox proportional-hazard models. Results: The median age was 62 years (interquartile range [IQR]: 54-68 years); 28.8% were female, 7225 (60.2%) patients were younger than 65-years, and 6927 (57.7%) patients had CHA2DS2-VASc score≥2. Over a total of 65,990 person-years follow-up commencing 90-days after first-time ablation, warfarin, DOACs, antiplatelets and ‘No-treatment’ exposures covered 30,877 (46.8%), 9,452 (14.3%), 6,003 (9.1%) and 19,657 (29.8%) person-years, respectively. There was no difference between DOACs vs warfarin (HR 1.04 [0.77-1.42]95%CI) while antiplatelets (HR 1.50 [1.11-2.05]95%CI) and No-Treatment (HR 1.50 [1.15-1.94]95%CI) were associated with a significantly higher rate of stroke. DOACs (HR 0.70 [0.54-0.92]95%CI), antiplatelets (HR 0.58 [0.41-0.82]95%CI) and No-Treatment (HR 0.52 [0.39-0.69]95%CI) were associated with a significantly lower rate of serious bleeding compared with warfarin. We found no difference between DOACs and warfarin (HR 0.87 [0.61-1.25]95%CI) while Antiplatelets (HR 1.42 [1.04-1.94]95%CI) and No-treatment (HR 2.77 [2.16-3.56]95%CI) were associated with a significantly higher rate of cardiovascular death. We observed no difference with DOACs (HR 0.86 [0.70-1.05]95%CI), antiplatelets (HR 1.04 [0.84-1.27]95%CI) or No-Treatment (HR 1.10 [0.93-1.31]]95%CI) compared to warfarin in multivariable analyses regarding the composite endpoint of MACE. Conclusions: Our study indicates a better bleeding risk profile associated with DOACs than warfarin in patients undergoing AF ablation, but no difference for the endpoints of stroke, cardiovascular death, or the composite endpoint of MACE. Despite the favourable bleeding risk, antiplatelets and No-Treatment compared with warfarin appear hazardous due to a higher rate of stroke and cardiovascular death.
Accurate orientation within true three-dimensional (3D) anatomies is essential for the successful radiofrequency (RF) catheter ablation of atrial fibrillation (AF) and atrial macro-re-entrant tachycardia (MRT). In this prospective study, ablation of AF and MRT was performed exclusively using a pre-acquired and integrated computed tomography (CT) image for anatomical 3D orientation without electro-anatomic reconstruction of the left atrium (LA).Fifty-four consecutive patients suffering from AF (n = 36) and/or MRT (n = 18) underwent RF catheter ablation. A 3D CT image was registered into the NavX-Ensite system without reconstruction of the atrial chamber anatomy. The quality of CT alignment was assessed and validated according to fluoroscopy information, electrogram characteristics, and tactile feedback at 31 pre-defined LA control points. The ablation of AF as well as mapping and ablation of MRT was performed within the 3D CT anatomy. In all patients, mapping and ablation could be performed without the reconstruction of the respective atrial chamber anatomy. The overall CT alignment was highly accurate with true surface contact in 90% (84%; 100%) of the control points. Complete isolation of all pulmonary vein (PV) funnels was achieved in 35 of 36 patients (97%) with AF. In patients with persistent AF (n = 11), additional isolation of the posterior LA (box lesion) and the placement of a mitral isthmus line were performed. The MRT mechanisms were as follows: around a PV ostium (n = 6), perimitral (n = 4), through LA roof (n = 5), septal (n = 2), and around left atrial appendage (n = 1). After a follow-up of 122 +/- 33 days, 22/25 (88%) patients with paroxysmal AF, 8/11 (73%) with persistent AF, and 16/18 (89%) with MRT remained free from arrhythmia recurrences.For patients with AF and MRT, our study shows the feasibility of successful placement of complex linear ablation line concepts guided by an integrated 3D image anatomy alone rather than catheter-based virtual chamber surface reconstructions.