Showing papers in "Europace in 2015"
TL;DR: In this article, the authors proposed AMIOdarone versus implantable cardioverter-defibrillator (ICD-DV) for the treatment of atrial fibrillation.
Abstract: ACC
: American College of Cardiology
ACE
: angiotensin-converting enzyme
ACS
: acute coronary syndrome
AF
: atrial fibrillation
AGNES
: Arrhythmia Genetics in the Netherlands
AHA
: American Heart Association
AMIOVIRT
: AMIOdarone Versus Implantable cardioverter-defibrillator:
1,513 citations
TL;DR: The current manuscript is an update of the original Practical Guide, published in June 2013, and listed 15 topics of concrete clinical scenarios for which practical answers were formulated, based on available evidence.
Abstract: The current manuscript is an update of the original Practical Guide, published in June 2013[Heidbuchel H, Verhamme P, Alings M, Antz M, Hacke W, Oldgren J, et al. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013;15:625-51; Heidbuchel H, Verhamme P, Alings M, Antz M, Hacke W, Oldgren J, et al. EHRA practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation: executive summary. Eur Heart J 2013;34:2094-106]. Non-vitamin K antagonist oral anticoagulants (NOACs) are an alternative for vitamin K antagonists (VKAs) to prevent stroke in patients with non-valvular atrial fibrillation (AF). Both physicians and patients have to learn how to use these drugs effectively and safely in clinical practice. Many unresolved questions on how to optimally use these drugs in specific clinical situations remain. The European Heart Rhythm Association set out to coordinate a unified way of informing physicians on the use of the different NOACs. A writing group defined what needs to be considered as 'non-valvular AF' and listed 15 topics of concrete clinical scenarios for which practical answers were formulated, based on available evidence. The 15 topics are (i) practical start-up and follow-up scheme for patients on NOACs; (ii) how to measure the anticoagulant effect of NOACs; (iii) drug-drug interactions and pharmacokinetics of NOACs; (iv) switching between anticoagulant regimens; (v) ensuring adherence of NOAC intake; (vi) how to deal with dosing errors; (vii) patients with chronic kidney disease; (viii) what to do if there is a (suspected) overdose without bleeding, or a clotting test is indicating a risk of bleeding?; (xi) management of bleeding complications; (x) patients undergoing a planned surgical intervention or ablation; (xi) patients undergoing an urgent surgical intervention; (xii) patients with AF and coronary artery disease; (xiii) cardioversion in a NOAC-treated patient; (xiv) patients presenting with acute stroke while on NOACs; and (xv) NOACs vs. VKAs in AF patients with a malignancy. Additional information and downloads of the text and anticoagulation cards in >16 languages can be found on an European Heart Rhythm Association web site (www.NOACforAF.eu).
1,123 citations
TL;DR: A critical review of new HRV methodologies and their application in different physiological and clinical studies, with particular attention paid to methodologies that have not been reported in the 1996 standardization document but have been more recently tested in sufficiently sized populations.
Abstract: Following the publication of the Task Force document on heart rate variability (HRV) in 1996, a number of articles have been published to describe new HRV methodologies and their application in different physiological and clinical studies. This document presents a critical review of the new methods. A particular attention has been paid to methodologies that have not been reported in the 1996 standardization document but have been more recently tested in sufficiently sized populations. The following methods were considered: Long-range correlation and fractal analysis; Short-term complexity; Entropy and regularity; and Nonlinear dynamical systems and chaotic behaviour. For each of these methods, technical aspects, clinical achievements, and suggestions for clinical application were reviewed. While the novel approaches have contributed in the technical understanding of the signal character of HRV, their success in developing new clinical tools, such as those for the identification of high-risk patients, has been rather limited. Available results obtained in selected populations of patients by specialized laboratories are nevertheless of interest but new prospective studies are needed. The investigation of new parameters, descriptive of the complex regulation mechanisms of heart rate, has to be encouraged because not all information in the HRV signal is captured by traditional methods. The new technologies thus could provide after proper validation, additional physiological, and clinical meaning. Multidisciplinary dialogue and specialized courses in the combination of clinical cardiology and complex signal processing methods seem warranted for further advances in studies of cardiac oscillations and in the understanding normal and abnormal cardiac control processes.
518 citations
TL;DR: This systematic review on risk factors for CIED infection may contribute to developing better infection control strategies for high-risk patients and can also help risk assessment in the management of device revisions.
Abstract: Infectious complications after cardiac implantable electronic device (CIED) implantation are increasing over time and are associated with substantial mortality and healthcare costs. The aim of this study was to systematically summarize the literature on risk factors for infection after pacemaker, implantable cardioverter-defibrillator, and cardiac resynchronization therapy device implantation. Electronic searches (up to January 2014) were performed in PubMed, Scopus, and Web of Science databases. Sixty studies (21 prospective, 9 case-control, and 30 retrospective cohort studies) met the inclusion criteria. The average device infection rate was 1-1.3%. In the meta-analysis, significant host-related risk factors for infection included diabetes mellitus (odds ratio (OR) [95% confidence interval] = 2.08 [1.62-2.67]), end-stage renal disease (OR = 8.73 [3.42-22.31]), chronic obstructive pulmonary disease (OR = 2.95 [1.78-4.90]), corticosteroid use (OR = 3.44 [1.62-7.32]), history of the previous device infection (OR = 7.84 [1.94-31.60]), renal insufficiency (OR = 3.02 [1.38-6.64]), malignancy (OR = 2.23 [1.26-3.95]), heart failure (OR = 1.65 [1.14-2.39]), pre-procedural fever (OR = 4.27 [1.13-16.12]), anticoagulant drug use (OR = 1.59 [1.01-2.48]), and skin disorders (OR = 2.46 [1.04-5.80]). Regarding procedure-related factors, post-operative haematoma (OR = 8.46 [4.01-17.86]), reintervention for lead dislodgement (OR = 6.37 [2.93-13.82]), device replacement/revision (OR = 1.98 [1.46-2.70]), lack of antibiotic prophylaxis (OR = 0.32 [0.18-0.55]), temporary pacing (OR = 2.31 [1.36-3.92]), inexperienced operator (OR = 2.85 [1.23-6.58]), and procedure duration (weighted mean difference = 9.89 [0.52-19.25]) were all predictors of CIED infection. Among device-related characteristics, abdominal pocket (OR = 4.01 [2.48-6.49]), epicardial leads (OR = 8.09 [3.46-18.92]), positioning of two or more leads (OR = 2.02 [1.11-3.69]), and dual-chamber systems (OR = 1.45 [1.02-2.05]) predisposed to device infection. This systematic review on risk factors for CIED infection may contribute to developing better infection control strategies for high-risk patients and can also help risk assessment in the management of device revisions.
323 citations
TL;DR: The use of CF with the above guidelines and contiguous deployment of RF lesions in EFFICAS II study resulted in more durable PVI in catheter ablation of PAF.
Abstract: Aims A challenge of pulmonary vein isolation (PVI) in catheter ablation for paroxysmal atrial fibrillation (PAF) is electrical reconnection of the PV. EFFICAS I showed correlation between contact force (CF) parameters and PV durable isolation but no prospective evaluation was made. EFFICAS II was a multicentre study to prospectively assess the impact of CF guidance for an effective reduction of PVI gaps.
Methods and results Pulmonary vein isolation using a radiofrequency (RF) ablation catheter with an integrated force sensor (TactiCath™) was performed in patients with PAF. Operators were provided EFFICAS I-based CF guidelines [target 20 g, range 10–30 g, minimum 400 g s force-time integral (FTI)]. Conduction gaps were assessed by remapping of PVs after 3 months, and gap rate was compared with EFFICAS I outcome. At follow up, 24 patients had 85% of PVs remaining isolated, compared with 72% in EFFICAS I ( P = 0.037) in which CF guidelines were not used. The remaining 15% of gaps correlated to the number of catheter moves at creating the PVI line, quantified as Continuity Index. For PV lines with contiguous lesions and low catheter moves, durable isolation was 81% in EFFICAS I and 98% in EFFICAS II ( P = 0.005). At index procedure, the number of lesions was reduced by 15% in EFFICAS II vs. EFFICAS I.
Conclusion The use of CF with the above guidelines and contiguous deployment of RF lesions in EFFICAS II study resulted in more durable PVI in catheter ablation of PAF.
[10.1093/europace/euv131][1]
[1]: /lookup/doi/10.1093/europace/euv131
290 citations
TL;DR: Among oral anticoagulation-naïve AF patients initiated on oral antICOagulation in Denmark, warfarin initiation has declined since the introduction of dabigatran in August 2011; however, use of rivaroxaban and apixaban is increasing.
Abstract: Aims Non-vitamin K antagonist oral anticoagulation (NOAC) agents have been approved for stroke prophylaxis in atrial fibrillation (AF). We investigated ‘real-world’ information on how these drugs are being adopted.
Methods and results Using Danish nationwide administrative registers, we identified all oral anticoagulation-naive AF patients initiating oral anticoagulation from 22 August 2011 through 31 October 2013. Using logistic regression analysis, baseline characteristics and temporal utilization trends were compared between initiators of warfarin vs. one of the N OACs: dabigatran, rivaroxaban, or apixaban. We identified 18 611 oral anticoagulation-naive AF patients of which 9902 (53%) initiated warfarin treatment, 7128 (38%) dabigatran, 1303 (7%) rivaroxaban, and 278 (1%) apixaban. Overall, 40% of newly initiated patients were started on dabigatran within the first 4 months of when the drug came on market. By October, 2013, 40% were being started on warfarin and dabigatran, respectively, and another 20% were started on either rivaroxaban or apixaban. Rivaroxaban and apixaban users generally had a higher predicted risk of stroke and bleeding compared with warfarin and dabigatran users. Older age, female gender, and prior stroke were some of the factors associated with NOAC use vs. warfarin, whereas chronic kidney disease, myocardial infarction, and heart failure showed the opposite association.
Conclusion Among oral anticoagulation-naive AF patients initiated on oral anticoagulation in Denmark, warfarin initiation has declined since the introduction of dabigatran in August 2011. Dabigatran is the most frequently used alternative option to warfarin; however, use of rivaroxaban and apixaban is increasing. Patients initiated with rivaroxaban or apixaban in general have a higher predicted stroke and bleeding risks compared with warfarin or dabigatran initiators.
[10.1093/europace/euu223][1]
[1]: /lookup/doi/10.1093/europace/euu223
155 citations
TL;DR: Female subjects were older and more symptomatic, compared with males, and were more likely to receive rate control, and also, female patients were at higher stroke risk overall, but oral anticoagulation was used in a high proportion of patients.
Abstract: Aims Sex differences in the epidemiology and clinical management of AF are evident. Of note, females are more symptomatic and if age >65, are at higher risk of thromboembolism if incident AF develops, compared with males.
Methods and results In an analysis from the dataset of the Euro Observational Research Programme on Atrial Fibrillation (EORP-AF) Pilot survey ( n = 3119), we examined sex-related differences in presentation, treatment, and outcome of contemporary patients with AF in Europe.Female subjects were older ( P < 0.0001), with a greater proportion aged ≥75 years, with more heart failure and hypertension. Heart failure with preserved ejection fraction was more common in females ( P < 0.0001), as was valvular heart disease ( P = 0.0003). Females were more symptomatic compared with males with a higher proportion being EHRA Class III and IV ( P = 0.0012). The more common symptoms that were more prevalent in females were palpitations ( P < 0.0001) and fear/anxiety ( P = 0.0007). Other symptoms (e.g. dyspnoea, chest pain, fatigue, etc.) were not different between males and females. Health status scores were significantly lower for females overall, specifically for the psychological and physical domains (both P < 0.0001) but not for the sexual activity domain ( P = 0.9023). Females were less likely to have electrical cardioversion (18.9 vs. 25.5%, P < 0.0001), and more likely to receive rate control ( P = 0.002). Among patients recruited in hospital and discharged alive ( n = 2009), documented contraindications to vitamin K antagonist (VKA) were evident in 23.8% of females. A CHA2DS2-VASc score ≥2 was found in 94.7% of females and 74.6% of males ( P < 0.0001), with oral anticoagulants being used in 95.3 and 76.2%, respectively ( P < 0.0001). A HAS-BLED score of ≥3 was found in 12.2% of females and 14.5% of males. Independent predictors of VKA use in females on multivariate analysis were CHA2DS2-VASc score ( P = 0.0007), lower HAS-BLED score ( P = 0.0284), and prosthetic mechanical valves ( P = 0.0276).
Conclusion The EORP-AF Pilot survey provides contemporary data on sex differences in clinical features and management of AF patients participating in the EORP-AF Pilot registry. Female subjects were older and more symptomatic, compared with males, and were more likely to receive rate control. Also, female patients were at higher stroke risk overall, but oral anticoagulation was used in a high proportion of patients.
151 citations
TL;DR: These statistics indicate that despite significant improvements, there still is considerable heterogeneity in the availability of arrhythmia therapies across the ESC area.
Abstract: Aims There has been large variations in the use of invasive electrophysiological therapies in the member countries of the European Society of Cardiology (ESC). The aim of this analysis was to provide comprehensive information on cardiac implantable electronic device (CIED) and catheter ablation therapy trends in the ESC countries over the last five years.
Methods The European Heart Rhythm Association (EHRA) has collected data on CIED and catheter ablation therapy since 2008. Last year 49 of the 56 ESC member countries provided data for the EHRA White Book. This analysis is based on the current and previous editions of the EHRA White Book. Data on procedure rates together with information on economic aspects, local reimbursement systems and training activities are presented for each ESC country and the five geographical ESC regions.
Results In 2013, the electrophysiological procedure rates per million population were highest in Western Europe followed by the Southern and Northern European countries. The CIED implantation and catheter ablation rate was lowest in the Eastern European and in the non-European ESC countries, respectively. However, in some Eastern European countries with relative low gross domestic product procedure rates exceeded those of some wealthier Western countries, suggesting that economic resources are not the only driver for utilization of arrhythmia therapies.
Conclusion These statistics indicate that despite significant improvements, there still is considerable heterogeneity in the availability of arrhythmia therapies across the ESC area. Hopefully, these data will help identify areas for improvement and guide future activities in cardiac arrhythmia management.
150 citations
TL;DR: The present document covers the antithrombotic management during different ablation procedures, implantation or exchange of cardiac implantable electronical devices (CIEDs), as well as the management of peri-interventional bleeding complications.
Abstract: Since the advent of the non-vitamin K antagonist oral anticoagulant (NOAC) agents, which act as direct thrombin inhibitors or inhibitors of Factor Xa, clinicians are provided with valuable alternatives to vitamin K antagonists (VKAs). At the same time, electrophysiologists frequently perform more invasive procedures, increasingly involving the left chambers of the heart. Thus, they are constantly faced with the dilemma of balancing the risk for thromboembolic events and bleeding complications. These changes in the rapidly evolving field mandate an update of the European Heart Rhythm Association (EHRA) 2008 consensus document on this topic.1 The present document covers the antithrombotic management during different ablation procedures, implantation or exchange of cardiac implantable electronical devices (CIEDs), as well as the management of peri-interventional bleeding complications.
The document is not a formal guideline and due to the lack of prospective randomized controlled trials (RCTs) for many of the clinical situations encountered, the recommendations are often ‘expert opinion’. The document strives to be practical for which reason we subdivided it in the three main topics: ablation procedure, CIED implantation or generator change, and issues of peri-interventional bleeding complications on concurrent antiplatelet therapy. For quick reference, every subchapter is followed by a short section on consensus recommendations.
Many RCTs are ongoing in this field and it is hoped that this document will help to prompt further well-designed studies.
### Ablation of atrial fibrillation, left atrial arrhythmias and right sided atrial flutter
In patients with symptomatic paroxysmal or even persistent atrial fibrillation (AF), catheter ablation is indicated when antiarrhythmic drugs have failed in controlling recurrences or even as a first-line therapy in selected patients.2–4
Patients with AF have an increased risk of thromboembolic events, which varies according to the presence of several risk factors.5,6 Apart from their intrinsic thromboembolic risks, ablation in these patients increases thromboembolic risk due to the introduction and manipulation …
147 citations
TL;DR: Radiofrequency catheter ablation seems to be more effective than medical therapy as first-line treatment of paroxysmal AF in relatively young and otherwise healthy patients, but may also cause more severe adverse effects.
Abstract: Aims New evidence about first-line radiofrequency catheter ablation (RFA) in symptomatic atrial fibrillation (AF) has emerged. In a single study the comparative treatment effect is potentially diminished by the high rate of cross-over to the alternative therapy. Therefore, we conducted a systematic review and meta-analysis of the available data to further evaluate the efficacy and safety of RFA vs. antiarrhythmic drugs (AADs).
Methods and results Five databases were searched for randomized controlled trials comparing RFA and AAD therapy as first-line treatment of AF in August 2014. Three studies with 491 patients with recurrent symptomatic AF were included. The patients were relatively young and the majority of them had paroxysmal AF (98.7%) and no major comorbidity. Radiofrequency catheter ablation was associated with significantly higher freedom from AF recurrence compared with AAD therapy [risk ratio (RR) 0.63, 95% confidence interval (CI) 0.44–0.92, P = 0.02]. The difference in the rate of symptomatic AF recurrences was not statistically significant (RR 0.57, 95% CI 0.30–1.08, P = 0.09). There was one procedure-related death and seven tamponades with RFA, whereas symptomatic bradycardia was more frequent with AAD therapy.
Conclusion Radiofrequency catheter ablation seems to be more effective than medical therapy as first-line treatment of paroxysmal AF in relatively young and otherwise healthy patients, but may also cause more severe adverse effects. These findings support the use of RFA as first-line therapy in selected patients, who understand the benefits and risks of the procedure.
141 citations
TL;DR: With the use of a decision analytic simulation model, it has been shown that screening for asymptomatic AF in 75/76-year-old individuals is cost-effective.
Abstract: Aims The aim of this study was to estimate the cost-effectiveness of 2 weeks of intermittent screening for asymptomatic atrial fibrillation (AF) in 75/76-year-old individuals. Methods and results T ...
TL;DR: The proper definition of adherence in terms of its three elements: initiation, implementation, and discontinuation is discussed; how adherence is reliably and accurately measured and successfully enhanced, to achieve and maintain safe and effective levels of NOAC-based anticoagulation are discussed.
Abstract: Suboptimal medication adherence is a widespread problem in ambulatory care of chronic diseases, with deviations in either direction from the prescribed dosing regimen. For the non-vitamin K antagonist oral anticoagulants (NOACs), such deviations occur and can lead to bleeding or clotting, as suboptimal adherence involves temporary periods of either overdosing or underdosing. In this expert review, we discuss: (a) the proper definition of adherence in terms of its three elements: initiation, implementation, and discontinuation; (b) how adherence is reliably and accurately measured and (c) successfully enhanced, to achieve and maintain safe and effective levels of NOAC-based anticoagulation. We also discuss the comparative effects of prescribing the same total daily dose, given either once-daily or as half-strength twice-daily doses. Because NOACs have plasma half-lives of ∼12 h, the twice-daily dosing regimen is less prone than the once-daily dosing regimen to hazardously high peaks or hazardously low troughs in anticoagulant concentrations and associated actions. As in other fields of oral drug treatment, the continuity of drug action is greater with twice-daily than with once-daily dosing, despite the fact that a few more doses are skipped with twice-daily than with once-daily dosing. This paradox is explained by the disproportionately greater impact on drug action of skipping a once-daily than a twice-daily dose. Integration of these principles into real-world medication management is the next step in the improvement of oral anticoagulation.
TL;DR: Pulmonary vein isolation using CF-guided RF and second-generation CB leads to comparable single-procedure arrhythmia-free survival at up to 18 months with similar overall complication rate.
Abstract: Aims Whether pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) using contact force (CF)-guided radiofrequency (RF) or second-generation cryoballoon (CB) present similar efficacy and safety remains uncertain.
Methods and results We performed a multicentre study comparing procedural safety and arrhythmia recurrence after standardized PVI catheter ablation for PAF using CF-guided RF ablation (Thermocool® SmartTouch™, Biosense Webster; or Tacticath™, St Jude Medical) (CF group) with second-generation CB ablation (Arctic Front Advance™, Medtronic) (CB group). Overall, 376 patients (mean age 59.8 ± 10.4 years, 280 males) were enrolled in 4 centres: 198 in CF group and 178 in CB group. Procedure was shorter for CB group than for CF group (109.6 ± 40 vs. 122.5 ± 40.7 min, P = 0.003), but fluoroscopy duration and X-ray exposure were not statistically different ( P = 0.1 and P = 0.22, respectively). Overall complication rate was similar in both groups: 14 (7.1%) in the CF group vs. 13 (7.3%) in the CB group ( P = 0.93). However, transient right phrenic nerve palsy occurred only in CB group (10 patients, 5.6%; P = 0.001 vs. CF group) and severe non-lethal complications (embolic event, tamponade, or oesophageal injury) occurred only in CF group (5 patients, 2.5%; P = 0.03 vs. CB group). No periprocedural death occurred in either group. Single-procedure freedom from any atrial arrhythmias at 18 months post-ablation was comparable in CF group and CB group (76 vs. 73.3%, respectively, log rank P = 0.63).
Conclusion Pulmonary vein isolation using CF-guided RF and second-generation CB leads to comparable single-procedure arrhythmia-free survival at up to 18 months with similar overall complication rate.
TL;DR: Even in this cohort with high overall rates of oral anticoagulation use, ESC guideline-adherent antithrombotic management is associated with significantly better outcomes, including those related to mortality and TE, as well as the composite endpoint of 'cardiovascular death, any TE or bleeding'.
Abstract: Aims Guideline-adherent therapy for stroke prevention in atrial fibrillation has been associated with better outcomes, in terms of thromboembolism (TE) and bleeding.
Methods and results In this report from the EuroObservational Research Programme-Atrial Fibrillation (EORP-AF) Pilot General Registry, we describe the associated baseline features of ‘high risk’ AF patients in relation to guideline-adherent antithrombotic treatment, i.e. whether they were adherent, over-treated, or under-treated based on the 2012 European Society of Cardiology (ESC) guidelines. Secondly, we assessed the predictors of guideline-adherent antithrombotic treatment. Thirdly, we evaluated outcomes for all-cause mortality, TE, bleeding, and the composite endpoint of ‘any TE, cardiovascular death or bleeding’ in relation to whether they were ESC guideline-adherent treatment. From the EORP-AF cohort, the follow-up dataset of 2634 subjects was used to assess the impact of guideline adherence or non-adherence. Of these, 1602 (60.6%) were guideline adherent, whilst 458 (17.3%) were under-treated, and 574 (21.7%) were over-treated. Non-guideline-adherent treatment can be related to region of Europe as well as associated clinical features, but not age, AF type, symptoms, or echocardiography indices. Over-treatment per se was associated with symptoms, using the EHRA score, as well as other comorbidities. Guideline-adherent antithrombotic management based on the ESC guidelines is associated with significantly better outcomes. Specifically, the endpoint of ‘all cause death and any TE’ is increased by >60% by undertreatment [hazard ratio (HR) 1.679 (95% confidence interval (CI) 1.202–2.347)] or over-treatment [HR 1.622 (95% CI 1.173–2.23)]. For the composite endpoint of ‘cardiovascular death, any TE or bleeding’, over-treatment increased risk by >70% [HR 1.722 (95% CI 1.200–2.470)].
Conclusion Even in this cohort with high overall rates of oral anticoagulation use, ESC guideline-adherent antithrombotic management is associated with significantly better outcomes, including those related to mortality and TE, as well as the composite endpoint of ‘cardiovascular death, any TE or bleeding’. These contemporary observations emphasize the importance of guideline implementation, and adherence to the 2012 ESC guidelines for stroke prevention in AF.
TL;DR: Overall persistence with rivaroxaban therapy is high, with a discontinuation rate of ∼15% in the first year of treatment and few additional discontinuations thereafter, using data from a prospective, non-interventional oral anticoagulation registry.
Abstract: Aims Worldwide, rivaroxaban is increasingly used for stroke prevention in atrial fibrillation (SPAF) but little is known about the rates of or reasons for rivaroxaban discontinuations in daily care. Using data from a prospective, non-interventional oral anticoagulation (NOAC) registry, we analysed rivaroxaban treatment persistence.
Methods and results Persistence with rivaroxaban in SPAF was assessed in an ongoing, prospective, non-interventional registry of >2600 NOAC patients from daily care using the Kaplan–Meier time-to-first-event analysis. Reasons for and management of rivaroxaban discontinuation were assessed. Potential baseline risk factors for treatment discontinuation were evaluated using Cox regression analysis. Between October 2011 and April 2014, 1204 rivaroxaban SPAF patients were enrolled [39.3% switched from vitamin K antagonists (VKAs) and 60.7% newly treated patients]. Of these, 223 patients (18.5%) stopped rivaroxaban during follow-up (median 544 days), which translates into a discontinuation rate of 13.6 (95% CI 11.8–15.4) per 100 patient-years. Most common reasons for treatment discontinuations were bleeding complications (30% of all discontinuations), followed by other side-effects (24.2%) and diagnosis of stable sinus rhythm (9.9%). A history of chronic heart failure (HR 1.43; 95% CI 1.09–1.87; P = 0.009) or diabetes (HR 1.39; 95% CI 1.06–1.82; P = 0.018) were the only statistically significant baseline risk factors for rivaroxaban discontinuation. After discontinuation of rivaroxaban, patients received antiplatelet therapy (31.8%), VKA (24.2%), another NOAC (18.4%), heparin (9.9%), or nothing (15.7%).
Conclusion Our data indicate that overall persistence with rivaroxaban therapy is high, with a discontinuation rate of ∼15% in the first year of treatment and few additional discontinuations thereafter.
TL;DR: This unique consensus document focuses on patients, summarizing the available literature on patients' experiences of living with various cardiac tachyarrhythmias and their treatment preferences, and identifies gaps in knowledge which will help to inform clinical practice and future research.
Abstract: Cardiac tachyarrhythmias are recurrent or chronic and in some cases life-threatening conditions. Heart rhythm disturbances are often highly symptomatic and the psychological impact of the disease can be significant. Patients' beliefs and knowledge about their health (and illness), medications, and healthcare they receive are important determinants of whether or not they accept recommended treatments; influence their coping responses to their illness and treatment; adherence to recommended therapy; and ultimately affects health outcomes. Incorporation of patients' values and preferences for therapy should now be considered as an integral part of the decision-making process and treatment strategy.
It is important to acknowledge and understand the impact of cardiac tachyarrhythmias on the patient. To address this issue, a Task Force was convened by the European Heart Rhythm Association (EHRA), and endorsed by the Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulacion Cardiaca y Electrofisiologia (SOLEACE), with the remit to comprehensively review the published evidence available, to publish a joint consensus document on patient values and preferences for the management of cardiac tachyarrhythmias, and to provide up-to-date consensus recommendations for use in clinical practice.
Hence this unique consensus document focuses on patients, summarizing the available literature on patients' experiences of living with various cardiac tachyarrhythmias and their treatment preferences, and identifies gaps in knowledge which will help to inform clinical practice and future research. The document will also summarize key points for discussions with patients during consultations regarding their condition, treatment options, disease trajectory, treatment goals, and outcomes. Finally, this document provides links to useful resources and patient advocacy groups and organizations and professional societies relevant to each group of cardiac tachyarrhythmias.
### Patients' experiences of living with atrial fibrillation
The experience of living with atrial fibrillation (AF) has been investigated from several perspectives. Quantitative studies reveal that patients with AF generally report lower health-related quality …
TL;DR: It is suggested that CF-guided radiofrequency and cryotherapy present very similar performances in the setting of paroxysmal AF catheter ablation, as well as recurrence at 12 months.
Abstract: Aims In the setting of paroxysmal atrial fibrillation (AF), there are no available data comparing the mid-term outcome of patients undergoing pulmonary vein isolation (PVI) catheter ablation using contact-force (CF)-guided radiofrequency (RF) vs. second-generation balloon cryotherapy.
Methods and results Prospective single-centre evaluation, carried out from March 2011 to February 2013, comparing CF radiofrequency (Thermocool® SmartTouch™, Biosense Webster, Inc.) (CF group) with cryoballoon ablation (Arctic Front Advance™ 28 mm cryoballoon, Medtronic, Inc.) (CB group), in regards to procedural safety and efficacy, as well as recurrence at 12 months. Overall, 150 consecutive patients were enrolled (75 in each group). The characteristics of patients of both the groups were similar (61.2 ± 9.9 years, women 25.3%, mean AF duration 4.1 ± 4.0 years, mean CHA2DS2-VASc score 1.4 ± 1.3, mean HAS-BLED 1.4 ± 0.6). Duration of the procedure was significantly lower in the CF group (110.7 ± 32.5 vs. 134.5 ± 48.3 min, P = 0.001), with a lower duration of fluoroscopy (21.5 ± 8.5 vs. 25.3 ± 9.9 min, P = 0.017) and X-ray exposure (4748 ± 2411 cGy cm² vs. 7734 ± 5361 cGy cm², P = 0.001). In contrast, no significant difference was found regarding significant procedural complication (2.7 vs. 1.3% in CF and CB groups, respectively; P = 0.56), and PVI was eventually achieved in all cases. At 12 months, AF recurrence occurred in 11 patients (14.7%) in the CB group and in 9 patients (12.0%) in the CF group (HR = 1.20 95% CI 0.50–2.90; log rank P = 0.682).
Conclusions Our preliminary findings suggest that CF-guided radiofrequency and cryotherapy present very similar performances in the setting of paroxysmal AF catheter ablation.
TL;DR: In this paper, the risk of thromboembolism in a nationwide cohort of atrial fibrillation patients undergoing direct current (DC) cardioversion with or without oral anticoagulant coverage was estimated by calculating incidence rates and by multivariable adjusted Cox proportional hazard models.
Abstract: Aims To study the risk of thromboembolism in a nationwide cohort of atrial fibrillation patients undergoing direct current (DC) cardioversion with or without oral anticoagulant coverage.
Methods and results A retrospective study of 16 274 patients in Denmark discharged from hospital after a first-time DC cardioversion for atrial fibrillation between 2000 and 2008. Use of oral anticoagulant therapy within 90 days prior and 360 days after DC cardioversion was obtained from the Danish Register of Medicinal Product Statistics. The risk of thromboembolism was estimated by calculating incidence rates and by multivariable adjusted Cox proportional-hazard models. During the initial 30 days following discharge, the thromboembolic incidence rate was 10.33 per 100 patient-years for the no prior oral anticoagulant therapy group [ n = 5084 (31.2%)], as compared with 4.00 per 100 patient-years for the prior oral anticoagulant therapy group [ n = 11 190 (68.8%)], [hazard ratio associated with no prior oral anticoagulant therapy was 2.25; 95% confidence interval (CI), 1.43–3.53]. Thromboembolic risk stratification by the CHADS2 and CHA2DS2-VASc scores did not change the results. Hazard ratio with no oral anticoagulant therapy was 2.21; 95% CI, 0.79–6.77 and 2.40; 95% CI, 1.46–3.95 with CHA2DS2-VASc score 0–1 and CHA2DS2-VASc score 2 or more, respectively.
Conclusion Direct current cardioversion for atrial fibrillation without oral anticoagulation is associated with a high risk of thromboembolism. Notably, the risk is high in the initial period after cardioversion, indicating a hazardous association between DC cardioversion without anticoagulation and thromboembolism.
[10.1093/europace/euu292][1]
[1]: /lookup/doi/10.1093/europace/euu292
TL;DR: Atrial tachyarrhythmias occurrence during BP and longer time of PersAF seem to be significant predictors of arrhythmia recurrences after the index procedure, which is associated with shorter procedure time and radiation exposure as compared with RFCA.
Abstract: Aims To assess the 1 year efficacy of pulmonary vein isolation (PVI) as index procedure for persistent atrial fibrillation (PersAF) comparing conventional radiofrequency irrigated-tip catheter ablation (RFCA) using contact-force technology and ablation using the second-generation cryoballoon (CB-AdvA).
Methods and results One hundred consecutive patients (74 male, 74%; mean age 62.4 ± 9.6 years) with drug-refractory PersAF undergoing PVI using RFCA and CB-AdvA were enrolled. Follow-up was based on outpatient clinic visits including Holter-electrocardiograms. Recurrence of atrial tachyarrhythmias (ATas) was defined as a symptomatic or documented episode >30 s. Among 100 patients, 50 underwent RFCA whereas 50 CB-AdvA. Mean procedure and fluoroscopy times were 90.5 ± 41.7 vs. 140.2 ± 46.9 min and 14.5 ± 6.6 vs. 19.8 ± 6.8 min in the CB-Adv and in the RFCA group, respectively ( P < 0.01). At 1 year follow-up, after a 3 months blanking period (BP), freedom from ATas off-drugs after a single procedure was 60% (28/50 patients) in the CB-Adv and 56% (27/50 patients) in the RFCA group ( P = 0.71). Multivariate analysis demonstrated that PersAF duration ( P = 0.01) and relapses during BP ( P = 0.02) were independent predictors of ATa recurrences following the index procedure.
Conclusion Freedom from ATas following PersAF ablation with RFCA and CB-Adv is comparable at 1 year follow-up after a single procedure. Ablation with the CB-Adv is associated with shorter procedure time and radiation exposure as compared with RFCA. Atrial tachyarrhythmias occurrence during BP and longer time of PersAF seem to be significant predictors of arrhythmia recurrences after the index procedure.
TL;DR: Elevated pre-ablation M/H ratio was associated with an increased recurrence of AF after cryoballoon-based catheter ablation, which support the role of pre- ablation pro-inflammatory and pro-oxidant environment in AF recurrence after ablation therapy but suggest that other factors are also important.
Abstract: Aims Previous studies evidenced that increased monocyte count or activity and lower high-density lipoprotein (HDL) cholesterol levels were associated with more prevalent atrial fibrillation (AF) which attributed to pro-inflammatory and pro-oxidant effects. Monocyte-to-HDL ratio ( M / H ratio) is a recently emerged indicator of inflammation and oxidative stress which have been only studied in patients with chronic kidney disease. We aimed to investigate the prognostic impact of M / H ratio on AF recurrence after cryoballoon-based catheter ablation.
Methods and results A total of 402 patients (43.5% female, age 53.5 ± 10.9 years, and 80.8% paroxysmal AF) with symptomatic AF underwent initial cryoablation procedure. Patients were categorized into quartiles on the basis of their pre-procedural M / H ratio. Post-ablation blanking period was observed for 3 months. At a mean follow-up of 20.6 ± 6.0 months, 95 patients (23.6%) had developed AF recurrence. Atrial fibrillation recurrence rates from the lowest to the highest M / H ratio quartiles were 7.4, 7.4, 16.8, and 68.4%, respectively ( P < 0.001). On multivariate Cox regression analysis, the preablation M / H ratio (HR: 1.20, 95% CI: 1.15–1.25, P < 0.001), left atrial diameter, duration of AF history, and early AF recurrence were independent predictors of AF recurrence. Using a cut-off level of 11.48, the pre-ablation M/H ratio predicted AF recurrence during follow-up with a sensitivity of 85% and a specificity of 74%.
Conclusion Elevated pre-ablation M / H ratio was associated with an increased recurrence of AF after cryoballoon-based catheter ablation. Our results support the role of pre-ablation pro-inflammatory and pro-oxidant environment in AF recurrence after ablation therapy but suggest that other factors are also important.
TL;DR: This position statement by the European Heart Rhythm Association (EHRA) endorsed by the Heart Rhythm Society (HRS) offers a pragmatic approach to the rationale and requirement for an SU, based on specialist consensus, existing practice and scientific evidence.
Abstract: The European Society of Cardiology (ESC) has played an important role in advancing our understanding of the causes, optimal investigation, and management of syncope through publication of practice guidelines in 2001, 2004, and 2009.1–3 The 2009 ESC guidelines recommend the establishment of formal Syncope Units (SUs)—either virtual or physical site within a hospital or clinic facility—with access to syncope specialists and specialized equipment.3 In response, this position statement by the European Heart Rhythm Association (EHRA) endorsed by the Heart Rhythm Society (HRS) offers a pragmatic approach to the rationale and requirement for an SU, based on specialist consensus, existing practice and scientific evidence (see Appendix).
The panel consists of specialists who have experience in developing and leading such units representing cardiology, geriatric and general internal medicine, neurology, and emergency medicine.
This document is addressed to physicians and others in administration, who are interested in establishing an SU in their hospital, so that they can meet the standards proposed by ESC-EHRA-HRS.1–3
### Definition of syncope and transient loss of consciousness
Syncope is a transient loss of consciousness (T-LOC) due to transient global cerebral hypoperfusion, and is characterized by rapid onset, short duration, and spontaneous complete recovery. This definition of syncope has been developed by the Task Force for the Diagnosis and Management of Syncope of the ESC and endorsed by the EHRA, European Heart Failure Association and European Heart Rhythm Society. Transient loss of consciousness is a term that encompasses all disorders characterized by self-limited LOC, irrespective of mechanism.1–3 By including the mechanism of unconsciousness, i.e. transient global cerebral hypoperfusion, the current syncope definition excludes other causes of T-LOC such as epileptic seizures and concussion, as well as certain common syncope mimics, such as psychogenic pseudosyncope.
### Definition of a Syncope Unit
An SU is a facility featuring a standardized approach to the diagnosis and management …
TL;DR: 3D scar reconstruction using images from 3D-GRE sequence improves the overall delineation of CC prior to VT ablation.
Abstract: Aims Non-invasive depiction of conducting channels (CCs) is gaining interest for its usefulness in ventricular tachycardia (VT) ablation. The best imaging approach has not been determined. We compared characterization of myocardial scar with late-gadolinium enhancement cardiac magnetic resonance using a navigator-gated 3D sequence (3D-GRE) and conventional 2D imaging using either a single shot inversion recovery steady-state-free-precession (2D-SSFP) or inversion-recovery gradient echo (2D-GRE) sequence.
Methods and results We included 30 consecutive patients with structural heart disease referred for VT ablation. Preprocedural myocardial characterization was conducted in a 3 T-scanner using 2D-GRE, 2D-SSFP and 3D-GRE sequences, yielding a spatial resolution of 1.4 × 1.4 × 5 mm, 2 × 2 × 5 mm, and 1.4 × 1.4 × 1.4 mm, respectively. The core and border zone (BZ) scar components were quantified using the 60% and 40% threshold of maximum pixel intensity, respectively. A 3D scar reconstruction was obtained for each sequence. An electrophysiologist identified potential CC and compared them with results obtained with the electroanatomic map (EAM). We found no significant differences in the scar core mass between the 2D-GRE, 2D-SSFP, and 3D-GRE sequences (mean 7.48 ± 6.68 vs. 8.26 ± 5.69 and 6.26 ± 4.37 g, respectively, P = 0.084). However, the BZ mass was smaller in the 2D-GRE and 2D-SSFP than in the 3D-GRE sequence (9.22 ± 5.97 and 9.39 ± 6.33 vs. 10.92 ± 5.98 g, respectively; P = 0.042). The matching between the CC observed in the EAM and in 3D-GRE was 79.2%; when comparing the EAM and the 2D-GRE and the 2D-SSFP sequence, the matching decreased to 61.8% and 37.7%, respectively.
Conclusion 3D scar reconstruction using images from 3D-GRE sequence improves the overall delineation of CC prior to VT ablation.
TL;DR: In this article, the authors studied the progression of chronic kidney disease (CKD), defined as a glomerular filtration rate (GFR) of 3 months, and found that even mild forms of kidney disease are associated with an increased risk of cardiovascular morbidity and overall mortality.
Abstract: The kidney exerts multiple functions, and pathophysiological interactions between the kidney and the heart have important clinical implications, but it has only recently become clear that these interactions should be studied across the whole spectrum of reduced kidney function and not only in cases with severe, end-stage renal disease (ESRD), as has been done for many years.1 The prevalence of chronic kidney disease (CKD), defined as a glomerular filtration rate (GFR) of 3 months, exceeds 10% in the adult population and reaches 47% in subjects older than 70 years, according to data from the USA, with a trend towards a recent increasing prevalence.1,2
Many interactions between kidney and cardiovascular functions have important implications for clinical management and health policy ( Figure 1 ), since even mild forms of kidney disease are associated with an increased risk of cardiovascular morbidity and overall mortality, and renal function may worsen over time.1,3
Figure 1
Stages of the development and progression of chronic kidney disease (CKD), including complications and strategies to improve outcomes. Modified from Eckardt et al. 1 GFR, glomerular filtration rate.
Although cardiovascular disease (CVD) and cardiac disorders are more frequent and severe in CKD, they are often not recognized, or undertreated, in view of the complexity of patient management in this setting.4 On the other hand, the presence and evolution of CKD is often not evaluated and monitored in patients with various forms of heart diseases, including patients with cardiac rhythm disturbances, a setting where CKD is associated with challenging decision-making on the management of specific treatments and interventions. In patients with cardiac diseases, CKD predisposes to acute kidney injury and vice versa , and both may strongly influence clinical management of cardiac conditions.
Considering the need for increasing the awareness of …
TL;DR: Pacemaker and ICD implantation rates seem to have reached a level phase in Sweden, and Implantable cardioverter-defibrillator and CRT implantation rate are very low and do not reflect guideline indications.
Abstract: Aims The National Swedish Pacemaker and Implantable Cardioverter-Defibrillator (ICD) Registry collects prospective data on all pacemaker and ICD implants in Sweden. We aimed to report the 2012 findings of the Registry concerning electrical devices implantation rates and changes over time, 1 year complications, long-term device longevity and patient survival.
Methods and results Forty-four Swedish implanting centres continuously contribute implantation of pacemakers and ICDs to the Registry by direct data entry on a specific website. Clinical and technical information on 2012 first implants and postoperative complications were analysed and compared with previous years. Patient survival data were obtained from the Swedish population register database. In 2012, the mean pacemaker and ICD first implantation rates were 697 and 136 per million inhabitants, respectively. The number of cardiac resynchronization therapy (CRT) first implantations/million capita was 41 (CRT pacemakers) and 55 (CRT defibrillators), with only a slight increase in CRT-ICD rate compared with 2011. Most device implantations were performed in men. Complication rates for pacemaker and ICD procedures were 5.3 and 10.1% at 1 year, respectively. Device and lead longevity differed among manufacturers. Pacemaker patients were older at the time of first implant and had generally worse survival rate than ICD patients (63 vs. 82% after 5 years).
Conclusion Pacemaker and ICD implantation rates seem to have reached a level phase in Sweden. Implantable cardioverter-defibrillator and CRT implantation rates are very low and do not reflect guideline indications. Gender differences in CRT and ICD implantations are pronounced. Device and patient survival rates are variable, and should be considered when deciding device type.
TL;DR: It is shown that Arc-Adv-CB use is associated with lower late AF recurrences at the cost of an increased risk for PNP and intraprocedural vagal reactions.
Abstract: Aims The second-generation cryoballoon (Arctic Front Advance™) (Arc-Adv-CB) has a redesigned injection system which distributes the refrigerant homogenously to the frontal balloon surface. The aim of this study was to compare the efficacy and safety of the Arc-Adv-CB and its predecessor (Arctic Front™) (Arc-CB) in patients who underwent pulmonary vein isolation (PVI) for atrial fibrillation (AF).
Methods and results Three hundred and six patients (55.35 ± 10.60 years, 47.05% male) were included in the study. A total of 1205 pulmonary veins were attempted for PVI with either Arc-CB or Arc-Adv-CB. The follow-up durations were 30 (23–38) and 10 (8–13) months in Arc-CB and Arc-Adv-CB groups, respectively ( P < 0.001). When the blanking period was considered, freedom from AF after a single ablation procedure was 68.53 and 90.83% in patients undergoing PVI with Arc-CB and Arc-Adv-CB, respectively. The most frequent complication was transient phrenic nerve palsy (PNP) which occurred in five(2.54%) and nine(8.26%) of patients undergoing PVI with Arc-CB and Arc-Adv-CB, respectively ( P = 0.040). Left atrial (LA) diameter (hazard ratio, HR: 3.552, 95% CI: 2.034–6.201, P < 0.001), smoking history (HR:1.643, 95% CI: 1.011–2.671, P = 0.045), persistent AF (HR:1.725, 95% CI: 1.021–2.915, P = 0.041), duration of AF (HR:1.039, 95% CI: 1.000–1.080, P = 0.047), and early AF recurrence (HR:2.399, 95% CI: 1.443–3.989, P < 0.001) were associated with increased late AF recurrence. On the other hand, intraprocedural vagal reactions (HR: 0.550, 95% CI: 0.331–0.915, P = 0.021) and Arc-Adv-CB use (HR: 0.441, 95% CI: 0.225–0.866, P = 0.017) were associated with lower late AF recurrence. Left atrial diameter (HR: 3.072, 95% CI: 1.646–5.732, P < 0.001), early AF recurrence (HR: 1.906, 95% CI: 1.103–3.291, P = 0.021), and Arc-Adv-CB use (HR: 0.472, 95% CI: 0.239–0.931, P = 0.030) were independent predictors for late AF recurrence.
Conclusion Our study has shown that Arc-Adv-CB use is associated with lower late AF recurrences at the cost of an increased risk for PNP.
TL;DR: Advanced interatrial block is a key predictor for high risk of new-onset AF after a successful CTI ablation in patients with typical AFl and no prior history of AF.
Abstract: Aims A significant proportion of patients develop atrial fibrillation (AF) following cavotricuspid isthmus (CTI) ablation for typical atrial flutter (AFl). The objective of this study was to assess whether the presence of advanced interatrial block (aIAB) was associated with an elevated risk of AF after CTI ablation in patients with typical AFl and no prior history of AF. Methods and results This study included patients with typical AFl and no prior history of AF that were referred for CTI ablation. Patients were excluded when they had received repeat ablations or did not demonstrate a bidirectional block. In all patients, a post-ablation electrocardiogram (ECG) in sinus rhythm was evaluated for the presence of aIAB, defined as a P-wave duration ≥120 ms and biphasic morphology in the inferior leads. New-onset AF was identified from 12-lead ECGs, Holter monitoring, and device interrogations. The cohort comprised 187 patients (age 67 ± 10.7 years; ejection fraction 55.8 ± 11.2%). Advanced interatrial block was detected in 18.2% of patients, and left atrium was larger in patients with aIAB compared with those without aIAB (46.2 ± 5.9 vs. 43.1 ± 6.0 mm; P = 0.01). Over a median follow-up of 24.2 months, 67 patients (35.8%) developed new-onset AF. The incidence of new-onset AF was greater in patients with aIAB compared with those without aIAB (64.7 vs. 29.4%; P Conclusion Advanced interatrial block is a key predictor for high risk of new-onset AF after a successful CTI ablation in patients with typical AFl.
TL;DR: For catheter ablation of persistent AF, the '2C3L' strategy is a fixed approach associated with clinical efficacy similar to that of the 'stepwise' approach but with less RF delivery, fewer X-ray exposure, and shorter procedural time.
Abstract: Aims This prospective clinical trial was designed to evaluate the efficacy of an ablation strategy, namely ‘2C3L’, in the treatment of persistent atrial fibrillation (AF); and to compare its efficacy with that of the ‘stepwise’ approach, which has been acknowledged as a promising ablation technique for persistent AF.
Methods and results The ‘2C3L’ technique is a fixed ablation approach consisting of bilateral circumferential pulmonary vein antrum isolation (PVAI) and three linear ablation lesion sets across the mitral isthmus, left atrial roof, and cavo-tricuspid isthmus. One hundred and forty-six patients with persistent AF were randomized to undergo ablation by using the ‘2C3L’ or the ‘stepwise’ technique ( n = 73, respectively). The primary endpoint was freedom from any atrial tachyarrhythmia off antiarrhythmic drug (AAD) after a single procedure at follow-up. Twelve months after a single procedure, there was no difference in sinus rhythm (SR) maintenance rate between the two groups (67% for ‘2C3L’ vs. 60% for ‘stepwise’, P = 0.394; 95% confidence interval of between-group difference −8.7 to 22.4%). The procedure (222 ± 42 vs. 263 ± 41 min), fluoroscopy (41 ± 9 vs. 55 ± 8 min), and radiofrequency (RF) (107 ± 32 vs. 128 ± 38 min) time were significantly shorter in the ‘2C3L’ group (all P < 0.001). At 25 ± 5 months after the first procedure, 57.5 and 52.1% of patients from the ‘2C3L’ group and the ‘stepwise’ group were in SR off AAD ( P = 0.494), respectively.
Conclusions For catheter ablation of persistent AF, the ‘2C3L’ strategy is a fixed approach associated with clinical efficacy similar to that of the ‘stepwise’ approach but with less RF delivery, fewer X-ray exposure, and shorter procedural time.
TL;DR: A 'no-bonus'-freeze protocol for PVI using the second-generation 28 mm CB resulted in an 82% 1-year clinical success rate, suggesting a bonus freeze cycle following successful PVI may not be essential to superior clinical outcome.
Abstract: Aims Studies on the use of the second-generation 28 mm cryoballoon (CB) for the treatment of atrial fibrillation (AF) have reported superior 1-year clinical outcome Customarily, a bonus freeze cycle is applied after pulmonary vein isolation (PVI) The purpose of the present study was to assess the 1-year clinical outcome following PVI foregoing a bonus freeze cycle
Methods and results Patients with drug-refractory paroxysmal AF (PAF) or persistent AF underwent PVI using the second-generation 28 mm CB The freeze cycle duration was set at 240 s No bonus freeze cycle was applied Clinical follow-up (FU) included 12-lead ECGs and 24h-Holter ECGs at 3, 6, and 12 months A total of 45 patients (age 60 ± 11 years, mean LA diameter 421 ± 86 mm, n = 38 [84%] PAF) underwent CB-based PVI Of 177 pulmonary veins (PVs) identified, 176/177 (99%) PVs were successfully isolated The mean number of CB applications was 12 ± 04, 15 ± 08, 14 ± 07, 11 ± 03 and 17 ± 12 for the right superior PVs, right inferior PVs, left superior PVs, left inferior PVs, and left common PVs, respectively Mean procedure and fluoroscopy times were 113 ± 32 and 19 ± 7 min, respectively Phrenic nerve palsy occurred in 1/45 (2%) patients One of 45 (2%) patients was lost to FU After a mean FU period of 392 ± 58 (267–522) days including a 3-month blanking period, 36 of 44 (82%) patients remained in stable sinus rhythm Five out of eight patients with arrhythmia recurrence underwent a second procedure Only those PVs isolated with a single freeze cycle (5/11 PVs, 45%) demonstrated PV reconduction In contrast, no PV reconnection was found in PVs initially treated with multiple freeze cycles
Conclusions A ‘no-bonus’-freeze protocol for PVI using the second-generation 28 mm CB resulted in an 82% 1-year clinical success rate A bonus freeze cycle following successful PVI may not be essential to superior clinical outcome
TL;DR: Despite undisputable benefits, conventional pacemaker therapy is associated with specific complications related to the subcutaneous device and the transvenous leads, so miniaturized leadless pacemakers may have the potential to overcome some complications of conventional pacing.
Abstract: Despite undisputable benefits, conventional pacemaker therapy is associated with specific complications related to the subcutaneous device and the transvenous leads. Recently, two miniaturized leadless pacemakers, Nanostim™ (St. Jude Medical) and Micra™ (Medtronic), which can be completely implanted inside the right ventricle using steerable delivery systems, entered clinical application. The WiCS™-cardiac resynchronisation therapy (CRT) system (wireless cardiac stimulation for CRT, EBR Systems) delivers leadless left ventricular endocardial stimulation for cardiac resynchronization. In addition to obvious cosmetic benefits, leadless pacing systems may have the potential to overcome some complications of conventional pacing. However, acute and long-term complications still remains to be determined, as well as the feasibility of device explantation years after device placement.
TL;DR: It is demonstrated that LAAO is most commonly employed in patients at high thrombo-embolic risk in whom OAC is contraindicated and the complication rates remain significant.
Abstract: The purpose of this EP Wire was to assess the indications, techniques, and outcomes of left atrial appendage occlusion (LAAO) in Europe. Thirty-three European centres, all members of the European Heart Rhythm Association electrophysiology (EP) research network, responded to this survey by completing the questionnaire. The major indication for LAAO (94%) was the prevention of stroke in patients at high thrombo-embolic risk (CHA2DS2-VASc ≥ 2) and contraindications to oral anticoagulants (OACs). Twenty-one (64%) of the responding centres perform LAAO in their own institution and 80% implanted 30 or less LAAO devices in 2014. Two-dimensional transoesophageal echocardiography was the preferred imaging technique to visualize LAA before, during, and after LAAO in 79, 58, and 62% of the participating centres, respectively. Following LAAO, 49% of the centres prescribe vitamin K antagonists or novel OACs. Twenty-five per cent of the centres combine LAAO with pulmonary vein isolation. The periprocedural complications included death (range, 0-3%), ischaemic or haemorrhagic stroke (0-25%), tamponade (0-25%), and device embolization (0-20%). In conclusion, this EP Wire has demonstrated that LAAO is most commonly employed in patients at high thrombo-embolic risk in whom OAC is contraindicated. The technique is not yet very widespread and the complication rates remain significant.