Abstract
Aims
During the last decade, ablation has increasingly been used in rhythm control management of patients with atrial fibrillation (AF). Over time, experience and techniques have improved ...and indications for ablation have expanded. The purpose of this study was to investigate whether the recurrence rate of AF following ablation has improved during last decade.
Methods and results
Through Danish nationwide registers, all patients with first-time AF ablation, between 2005 and 2014 in Denmark were identified. Recurrent AF after ablation was identified with 1 year follow-up. A total of 5425 patients undergoing first-time ablation were included. While patient median age increased over time the median AF duration prior to ablation decreased. The rates of recurrent AF decreased from 45% in 2005–2006 to 31% 2013–2014 with the relative risk of recurrent AF almost halved with an odds ratio of 0.57 95% confidence intervals (95% CI) 0.47–0.68 in 2013–2014 compared with patients undergoing ablation in 2005–2006. Female gender, hypertension, AF duration >2 years, and cardioversion within 1 year prior to ablation were all associated with an increased risk of recurrent AF.
Conclusion
One year risk of recurrent AF following first-time ablation has almost halved from 2006 to 2014. Hypertension, female sex, cardioversion 1 year prior to ablation, and AF duration for more than 2 years all increased the associated risk of recurrent AF.
Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical ...trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications.
This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65 min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each).
In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement.
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.
To investigate the long-term risk of thromboembolism and serious bleeding associated with oral anticoagulation (OAC) therapy beyond 3 months after radiofrequency ablation (RFA) of atrial fibrillation ...(AF).
Linking Danish administrative registries, 4050 patients undergoing first-time RFA (2000-11) were identified. Risk of thromboembolism and serious bleeding according to OAC therapy were analysed by incidence rates (presented per 100 person-years) and Cox proportional-hazard models. The median age was 59.5 years (interquartile range, IQR: 52.8-65.2); 26.5% were females. During a median follow-up of 3.4 years (IQR: 2.0-5.6), 71 (1.8%) thromboembolism cases were identified, where incidence rates with and without OAC were 0.56 (0.40-0.78)95%CI and 0.64 (0.46-0.89)95%CI, respectively. Oral anticoagulation discontinuation remained insignificant hazard ratio 1.42(0.86-2.35)95%CI in multivariable analysis. Beyond 3 months after RFA 87 (2.1%) serious bleedings occurred; incidence rates with and without OAC were 0.99 (0.77-1.27)95%CI and 0.44 (0.29-0.65)95%CI, respectively. Oral anticoagulation therapy was significantly associated with serious bleeding risk hazard ratio 2.05(1.25-3.35)95%CI. In an age- and gender-matched cohort (1 : 4) of 15 848 non-ablated AF patients receiving rhythm-control therapy, thromboembolic rates with and without OAC were 1.34 (1.21-1.49)95%CI and 2.14 (1.98-2.30)95%CI, respectively. Adjusted incidence rate ratio was 0.53 (0.43-0.65)95%CI favouring RFA cohort.
Thromboembolic risk beyond 3 months after RFA was relatively low compared with a matched non-ablated AF cohort. With cautious interpretation due to low number of events, serious bleeding risk associated with OAC seems to outweigh the benefits of thromboembolic risk reduction. Randomized studies are warranted to test our results.
Objectives This study sought to examine the risk of major cardiac adverse events and death in a nationwide cohort of patients without previous comorbidity admitted for syncope. Background Syncope is ...a common clinical event, but knowledge of prognosis is not fully elucidated in healthy individuals. Methods Patients without previous comorbidity admitted for syncope in Denmark from 2001 to 2009 were identified in nationwide administrative registries and matched by sex and age with 5 control subjects from the Danish population. The risk of death or recurrent syncope, implantation of pacemaker or implantable cardioverter-defibrillator, and cardiovascular hospitalization were analyzed with multivariable Cox proportional hazard models. Results We identified 37,017 patients with a first-time diagnosis of syncope and 185,085 control subjects; their median age was 47 years (interquartile range, 32 to 63 years) and 47% were male. A total of 3,023 (8.2%) and 14,251 (7.1%) deaths occurred in the syncope and the control population, respectively, yielding an event rate of 14.3 per 1,000 person-years (PY) in the syncope population. Multivariable Cox regression analysis demonstrated a significantly increased risk of all-cause mortality (hazard ratio HR: 1.06; 95% confidence interval CI: 1.02 to 1.10), cardiovascular hospitalization event rate of 26.5 per 1,000 PY (HR: 1.74; 95% CI: 1.68 to 1.80), recurrent syncope event rate of 45.1 per 1,000, stroke event rate of 6.8 per 1,000 PY (HR: 1.35; 95% CI: 1.27 to 1.44), and pacemaker or implantable cardioverter-defibrillator event rate of 4.2 per 1,000 PY (HR: 5.52; 95% CI: 4.67 to 5.73; p < 0.0001). Conclusions The first admission for syncope among healthy individuals significantly predicts the risk of all-cause mortality, stroke, cardiovascular hospitalization, device implantation, and recurrent syncope.
Acute exposure to hypoxia causes chemoreflex activation of the sympathetic nervous system. During acclimatization to high
altitude hypoxia, arterial oxygen content recovers, but it is unknown to what ...degree sympathetic activation is maintained
or normalized during prolonged exposure to hypoxia. We therefore measured sympathetic nerve activity directly by peroneal
microneurography in eight healthy volunteers (24 ± 2 years of age) after 4 weeks at an altitude of 5260 m (Chacaltaya, Bolivian
Andes) and at sea level (Copenhagen). The subjects acclimatized well to altitude, but in every subject sympathetic nerve activity
was highly elevated at altitude vs. sea level (48 ± 5 vs. 16 ± 3 bursts min â1 , respectively, P < 0.05), coinciding with increased mean arterial blood pressure (87 ± 3 vs. 77 ± 2 mmHg, respectively, P < 0.05). To examine the underlying mechanisms, we administered oxygen (to eliminate chemoreflex activation) and saline (to
reduce cardiopulmonary baroreflex deactivation). These interventions had minor effects on sympathetic activity (48 ± 5 vs. 38 ± 4 bursts min â1 , control vs. oxygen + saline, respectively, P < 0.05). Moreover, sympathetic activity was still markedly elevated (37 ± 5 bursts min â1 ) when subjects were re-studied under normobaric, normoxic and hypervolaemic conditions 3 days after return to sea level.
In conclusion, acclimatization to high altitude hypoxia is accompanied by a striking and long-lasting sympathetic overactivity.
Surprisingly, chemoreflex activation by hypoxia and baroreflex deactivation by dehydration together could account for only
a small part of this response, leaving the major underlying mechanisms unexplained.
Syncope could be related to high risk of falls and injury in adults, but documentation is sparse. We examined the association between syncope and subsequent fall-related injuries in a nationwide ...cohort.
By cross-linkage of nationwide registers, all residents ≥18 years with a first-time diagnosis of syncope were identified between 1997-2012. Syncope patients were matched 1:1 with individuals from the general population. The absolute one-year risk of fall-related injuries, defined as fractures and traumatic head injuries requiring hospitalization, was calculated using Aalen-Johansen estimator. Ratios of the absolute one-year risk of fall-related injuries (ARR) were assessed by absolute risk regression analysis.
We identified 125,763 patients with syncope: median age 65 years (interquartile range 46-78). At one year, follow-up was complete for 99.8% where a total of 8394 (6.7%) patients sustained a fall-related injury requiring hospitalization, of which 1606 (19.1%) suffered hip fracture. In the reference group, 4049 (3.2%) persons had a fall-related injury. The one-year ARR of a fall-related injury was 1.79 (95% confidence interval 1.72-1.87, P<0.001) in patients with syncope compared with the reference group; however, increased ARR was not exclusively in older patients. Factors independently associated with increased ARR of fall-related injuries in the syncope population were: injury in past 12 months, 2.39 (2.26-2.53, P<0.001), injury in relation to the syncope episode, 1.62 (1.49-1.77, P<0.001), and depression, 1.37 (1.30-1.45, P<0.001).
Patients with syncope were at 80% increased risk of severe fall-related injuries within the year following discharge. Notably, increased risk was not exclusively in older patients.
Determining the presence of modifiable risk factors for atrial fibrillation (AF), such as sleep apnea is of clinical importance due to the potential impact targeting these risk factors can have on ...the progression and burden of AF. Using new digital-based technology is a promising solution to the underreporting of sleep apnea highlighted by academical societies in recent years. The aim of this study is to report the prevalence and severity of sleep apnea in patients with AF and, secondarily, assess the accuracy and feasibility of a new home-screening device for sleep apnea (NightOwl™ by Ectosense).
DAN-APNO is a cross-sectional study at the Department of Cardiology, Herlev-Gentofte Hospital recruiting patients with AF referred to anticoagulation initiation aged 18 to 90 years without known sleep apnea. At least 150 patients will be recruited and undergo medical history, clinical evaluation, several sleep-apnea questionnaires, and a sleep-recording evaluation for four nights with sleep apnea home-monitoring device NightOwl™. Additionally, the first 20 participants and participants with moderate-severe sleep apnea by screening are referred to cardio-respiratory monitoring (CRM). This clinical evaluation allows the comparison of standard evaluation method and the NightOwl™. Clinical measures include Apnea-Hypopnea Index (AHI), Oxygen Desaturation Index (ODI), pulse rate, as well as questionaries about sleep apnea assessment and the clinical feasibility of the NightOwl™ device. Main outcomes comprise analysis of the prevalence and severity of sleep apnea, and clinical and demographic predictors of moderate and severe sleep apnea. In addition, correlation analyses for accuracy measures between CRM and NightOwl™ will be conducted along with patient ease-of-use and satisfaction questionnaires.
This study is limited by selection bias; only patients with atrial fibrillation from anticoagulation clinic is asked to participate, which could limit the generalizability of our results. However, this study aims to test whether a miniaturized simple home-monitoring device for detecting sleep apnea in patients with AF potentially can evaluate sleep apnea more conveniently and easier. Trial Registration The study is registered the 18-02-2021 at clinicaltrials.gov with registration number: NCT04760002.
Recurrent syncope is a major cause of hospitalizations and may be associated with cardiovascular co-morbidities. Despite this, prognostic factors and the clinical characteristics among patients are ...not well described. Therefore, we identified and analyzed data on all patients >50 years of age discharged after a first-time episode of syncope in the period 2001 to 2009 through nationwide administrative registries. We identified the clinical characteristics of 5,141 patients ≥85 years of age and 23,454 patients <85 years of age. Multivariate Cox models were used to assess prognostic factors associated with the end point of recurrent syncope according to age. We found that those with syncope and ≥85 years were more often women (65% vs 47%) and generally had a greater prevalence of noncardiovascular co-morbidities, whereas the prevalence of cardiovascular co-morbidities was more heterogeneously distributed across age groups. Overall, significant baseline predictors of recurrent syncope were aortic valve stenosis (hazard ratio HR 1.48, 95% confidence interval CI 1.31 to 1.68), impaired renal function (HR 1.34, 95% CI 1.15 to 1.58), atrioventricular or left bundle branch block (HR 1.32, 95% CI 1.16 to 1.51), male gender (HR 1.18, 95% CI 1.12 to 1.24), chronic obstructive pulmonary disorder (HR 1.10, 95% CI 1.02 to 1.19), heart failure (HR 1.10, 95% CI 1.02 to 1.21), atrial fibrillation (HR = 1.09, 95% CI 1.01 to 1.19), age per 5-year increment (HR 1.09, 95% CI 1.07 to 1.10), and orthostatic medications per increase (HR 1.06, 95% CI 1.03 to 1.09). Atrial fibrillation and impaired renal function both exhibited less prognostic importance for recurrent syncope in the elderly compared with younger population (p for interactions <0.01). In conclusion, predictive factors of recurrent syncope were closely associated with increased cardiovascular risk profile age and gender. The use of multiple orthostatic medications additively increased the risk of recurrences representing a need for strategies to reduce unnecessary polypharmacy.
Guidelines recommend prioritizing treatment with antiarrhythmic drugs before referral of patients with atrial fibrillation to ablation, delaying a potential subsequent ablation. However, delaying ...ablation may affect ablation outcomes. We sought to investigate the impact of duration from diagnosis to ablation on the risk of atrial fibrillation recurrence and adverse events.
Using Danish nationwide registries, all patients with first-time ablation for atrial fibrillation were identified and included from 2010 to 2018. Patients were divided into 4 groups by diagnosis-to-ablation time: <1.0 year (early ablation), 1.0 to 1.9 years, 2.0 to 2.9 years, and >2.9 years (late ablation). The primary end point was atrial fibrillation recurrence after the 90-day blanking period, defined by admission for atrial fibrillation, cardioversions, use of antiarrhythmic drugs, or repeat atrial fibrillation ablations. The secondary end point was a composite end point of heart failure, ischemic stroke, or death, and each event individually. The study cohort consisted of 7705 patients. The 5-year cumulative incidence of atrial fibrillation recurrence in the 4 groups was 42.9%, 54.8%, 55.9%, and 58.4%, respectively. Hazard ratios were 1.20 (95% CI, 1.07-1.35), 1.29 (95% CI, 1.13-1.47), and 1.40 (95% CI, 1.28-1.53), respectively, with the early ablation group as reference. The hazard ratio for the combined secondary end point was 1.22 (95% CI, 1.04-1.44) in the late ablation group compared with the early ablation group.
In patients undergoing ablation for atrial fibrillation, early ablation was associated with a significantly lower risk of atrial fibrillation recurrence. Furthermore, the associated risk of heart failure, ischemic stroke, or death was significantly lower in early-compared with late-ablation patients.
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