In this trial, patients with symptomatic paroxysmal atrial fibrillation were assigned to either radiofrequency ablation or antiarrhythmic drug therapy as first-line treatment. There was no ...significant difference between the groups in the cumulative burden of AF over a 2-year period.
Radiofrequency catheter ablation has emerged as an effective therapy for patients with paroxysmal atrial fibrillation who have recurrent episodes of arrhythmia despite antiarrhythmic drug therapy.
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It has been suggested that pulmonary-vein isolation can also be used as first-line treatment in selected patients with paroxysmal atrial fibrillation,
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and there are physiological reasons to assume that ablation as first-line therapy might be more effective than later intervention. Irreversible structural changes such as fibrosis and myolysis are commonly detected in the atria when atrial fibrillation has become persistent,
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and extensive atrial fibrosis detected by magnetic resonance imaging predicts a poor outcome . . .
Abstract
Aims
Device-related infection (DRI) is a severe complication to cardiac implantable electronic devices (CIED) therapy. Device-related infection incidence and its risk factors differ between ...previous studies. We aimed to define the long-term incidence and incidence rates of DRI for different types of CIEDs in the complete Danish device-cohort and identify patient-, operation- and device-related risk factors for DRI.
Methods and results
From the Danish Pacemaker (PM) and implantable cardioverter-defibrillator (ICD) Register, we included consecutive Danish patients undergoing CIED implantation or reoperation from January 1982 to April 2018, resulting in 97 750 patients, 128 045 operations and follow-up of in total 566 275 device years (DY). We identified 1827 DRI causing device removals. Device-related infection incidence during device lifetime was 1.19% (1.12–1.26) for PM, 1.91% (1.71–2.13) for ICD, 2.18% (1.78–2.64) for cardiac resynchronization therapy (CRT)-pacemakers (CRT-P), and 3.35% (2.92–3.83) for CRT-defibrillators (CRT-D). Incidence rates in de novo implantations were 2.04/1000 DY for PM, 3.84 for ICD, 4.38 for CRT-P, and 6.76 for CRT-D. Using multiple-record and multiple-event per subject proportional hazard analysis, we identified implantation of complex devices (ICD and CRT), reoperations, prior DRI, male sex, and younger age as significantly associated with higher DRI risk.
Conclusion
Overall risk of infection was low in PM implantations but considerably higher in CRT systems and after reinterventions. These data support the importance of evaluating all patients considered for CIED therapy thoroughly, in order to identify potential modifiable risk factors and reduce the risk of early reoperations.
The number of cardiac implantable electronic device (CIED) implantations has increased over recent years as a result of population growth, increasing life expectancy, adoption of guidelines, and ...better access to healthcare. Transvenous lead extraction (TLE), as a part of an overall lead management strategy, has also been increasing, not only as a consequence of this growth, but also because of increasing rates of infection, lead failure, awareness of indications for lead management, and development of extraction tools. Clinical research is essential for understanding efficacy and risks of TLE, which has important implications regarding decision-making and therapeutic strategies in patients who are candidates for this procedure. Data on TLE have mainly come from retrospective series, with variable reporting of endpoints. Recently, the ELECTRa registry conducted by the European Heart Rhythm Association (EHRA), has reported the largest prospective experience on lead extraction published to date in 3555 patients recruited from 19 European countries. There remain unresolved issues, which is a strong incentive for conducting further specifically-designed clinical trials to answer important questions in this area. In addition to clinical studies, national registries are potentially useful for evaluating epidemiology of TLE as well as for quality control and understanding resource implications. Standardization of definitions and reporting of parameters are paramount in order to analyse, compare, and pool data for scientific purposes. Expert consensus statements on lead extraction have been published by the Heart Rhythm Society (HRS) in 2009 and 2017, and by EHRA in 2012. Experience from the ELECTRa registry has been valuable for identifying challenges faced with conducting scientific studies in this field, and provides a framework for future endeavours.
This writing group has been commissioned by EHRA to provide recommendations for designing scientific studies, reports and registries relating to lead extraction.
The aim of this analysis was to provide comprehensive information on invasive cardiac arrhythmia therapies in the European Society of Cardiology (ESC) area over the past 10 years.
The European Heart ...Rhythm Association (EHRA) has collected data on invasive arrhythmia therapies since 2008. This year 53 of the 56 ESC member countries provided data for the EHRA White Book. Here we present updated data on procedure rates together with information on demographics, economy, vital statistics, local healthcare systems and training activities. Considerable heterogeneity in the access to invasive arrhythmia therapies still exists across the five geographical ESC regions. In 2016, the device implantation rates per million population were 3-6 times higher in the Western region than in the non-European and Eastern ESC member countries. Catheter ablation activity was highest in the Western countries followed by the Northern and Southern areas. In the non-European countries, atrial fibrillation ablation rate was more than tenfold lower than in the European countries. On the other hand, the growth rate over the past ten years was highest in the non-European and Eastern countries. In some Eastern European countries with relative low gross domestic product the procedure rates exceeded the average values.
It was encouraging to note that during the past decade the growth in invasive arrhythmia therapies was greatest in the areas historically with relatively low activity. Nevertheless, there is substantial disparity and continued efforts are needed to improve harmonization of cardiac arrhythmia therapies in the ESC area.
Abstract
Aims
It is recommended to perform atrial fibrillation ablation with continuous anticoagulation. Continuous apixaban has not been tested.
Methods and results
We compared continuous apixaban ...(5 mg b.i.d.) to vitamin K antagonists (VKA, international normalized ratio 2–3) in atrial fibrillation patients at risk of stroke a prospective, open, multi-centre study with blinded outcome assessment. Primary outcome was a composite of death, stroke, or bleeding (Bleeding Academic Research Consortium 2–5). A high-resolution brain magnetic resonance imaging (MRI) sub-study quantified acute brain lesions. Cognitive function was assessed by Montreal Cognitive Assessment (MoCA) at baseline and at end of follow-up. Overall, 674 patients (median age 64 years, 33% female, 42% non-paroxysmal atrial fibrillation, 49 sites) were randomized; 633 received study drug and underwent ablation; 335 undertook MRI (25 sites, 323 analysable scans). The primary outcome was observed in 22/318 patients randomized to apixaban, and in 23/315 randomized to VKA {difference −0.38% 90% confidence interval (CI) −4.0%, 3.3%, non-inferiority P = 0.0002 at the pre-specified absolute margin of 0.075}, including 2 (0.3%) deaths, 2 (0.3%) strokes, and 24 (3.8%) ISTH major bleeds. Acute small brain lesions were found in a similar number of patients in each arm apixaban 44/162 (27.2%); VKA 40/161 (24.8%); P = 0.64. Cognitive function increased at the end of follow-up (median 1 MoCA unit; P = 0.005) without differences between study groups.
Conclusions
Continuous apixaban is safe and effective in patients undergoing atrial fibrillation ablation at risk of stroke with respect to bleeding, stroke, and cognitive function. Further research is needed to reduce ablation-related acute brain lesions.
Aim
Left ventricular (LV) lead position at the latest mechanically activated non‐scarred myocardial LV region confers improved response to cardiac resynchronization therapy (CRT). We conducted a ...double‐blind, randomized controlled trial to evaluate the clinical benefit of multimodality imaging‐guided LV lead placement in CRT.
Methods and results
Patients were allocated (1:1) to imaging‐guided LV lead placement using cardiac computed tomography (CT) venography, 99mTechnetium myocardial perfusion imaging, and speckle‐tracking echocardiography radial strain to target the optimal coronary sinus (CS) branch closest to the non‐scarred myocardial segment with latest mechanical activation (imaging group, n = 89) or to routine LV lead implantation in a posterolateral region with late electrical activation (control group, n = 93). The primary endpoint was clinical non‐response to CRT ≥1 of the following after 6 months: (1) death, (2) heart failure hospitalization, or (3) no improvement in New York Heart Association class and <10% increase in 6‐min walk distance. Secondary outcomes included LV remodelling and the combination of all‐cause mortality and hospitalization owing to heart failure during 1.8 ± 0.9 years. Analysis was intention‐to‐treat. In the imaging group, fewer patients reached the primary endpoint (26% vs. 42%, P = 0.02). More patients in the imaging group had the LV lead placed in the optimal CS branch (83% vs. 65%, P = 0.01). There were no between‐group differences in reverse LV remodelling or the combined endpoint of death or hospitalizations for heart failure.
Conclusions
Multimodality imaging‐guided LV lead placement towards the CS branch closest to latest mechanically activated non‐scarred myocardial LV segment reduces the proportion of clinical non‐responders to CRT. Larger long‐term multicentre studies are needed.
The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial compared radiofrequency catheter ablation (RFA) with antiarrhythmic drug therapy ...(AAD) as first-line treatment for paroxysmal atrial fibrillation (AF). Endpoint of ablation was elimination of electrical activity inside pulmonary veins. We present the results of the 5-year follow-up.
This pre-specified 5-year follow-up included assessment of any AF and symptomatic AF burden by one 7-day Holter recording and quality of life (QoL) assessment, using SF-36 questionnaire physical and mental component scores. Analysis was intention-to-treat. Imputation was used to compensate for missing Holter data.
245 of 294 patients (83%) randomised to RFA (n=125) or AAD (n=120) attended the 5-year follow-up, 227 with Holter recording. Use of class I or III AAD was more frequent in AAD group (N=61 vs 13, p<0.001). More patients in the RFA group were free from AF (126/146 (86%) vs 105/148 (71%), p=0.001, relative risk (RR) 0.82; 95% CI 0.73 to 0.93) and symptomatic AF (137/146 (94%) vs 126/148 (85%), p=0.015, χ
test, RR 0.91; 95% CI 0.84 to 0.98) in 7-day Holter recording. AF burden was significantly lower in the RFA group (any AF: p=0.003; symptomatic AF: p=0.02). QoL scores did not differ between randomisation groups. QoL scores remained improved from baseline (both components p<0.001), and did not differ from 2-year scores.
At 5 years, the occurrence and burden of any AF and symptomatic AF were significantly lower in the RFA group than in the AAD group. Improved QoL scores observed after 2 years persisted after 5 years without between-group differences.
NCT00133211; Results.
In patients without any history of atrial fibrillation (AF), detection of subclinical atrial high rate episodes (AHRE) by implanted devices has been associated with an increased thromboembolic risk. ...The predictive value of AHREs in patients with cardiac resynchronization therapy (CRT) is uncertain.
We aimed to investigate the prognostic value of early detected AHRE in patients with CRT.
This observational study included patients who received CRT and no history of AF. Patients had standard indication for CRT treatment. They were screened for early detected AHREs longer than 6 minutes occurring before 6-month follow-up, and the longest duration of AHREs was recorded. Information on clinical AF and thromboembolic events was obtained from the Danish National Patient Registry. The Cox regression model was used to compute hazard ratios (HRs) with 95% confidence intervals (CIs).
Of 394 eligible patients, 79 patients (20%) had early AHRE detected. During a median follow-up of 4.6 years, patients with early detected AHREs had an increased risk of clinical AF (HR 2.35; 95% CI 1.47-3.74; P < .001) and thromboembolic events (HR 2.30; 95% CI 1.09-4.83; P = .028). For patients with AHREs longer than 24 hours, these associations were stronger. The risk of mortality was not higher with early detected AHREs (HR 0.97; 95% CI 0.64-1.45; P = .87). Of the 27 patients with thromboembolic events, only 10 patients (37%) had AHREs detected within a 2-month period before the thromboembolic event.
In patients without any history of AF, detection of early AHREs after CRT implantation is associated with a significantly increased risk of clinical AF and thromboembolic events, particularly AHRE longer than 24 hours.
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