Long-term outcomes of left atrial appendage occlusion in high-risk atrial fibrillation patients: 4-year follow up data.

Long-term follow-up data of left atrial appendage (LAA) occlusion in patients with atrial fibrillation (AF) are sparse. To address these data gaps, we analysed the 4-year outcomes of AF patients following LAA occlusion. The was a retrospective cohort study of high-risk patients with AF who underwent successful implantation of the Amulet device at our center between 2014 and 2017. Study endpoints were the rate of stroke, major bleeding and all-cause mortality. We included 71 patients (35.2% females) with a median age of 78 (IQR 73-82) years. Over a median follow-up period of 46 (IQR 19-56) months, the annual rate of ischemic stroke was 1.06 events/100 patient-years (95% CI 0-2.35), hemorrhagic stroke was 1.06 events/100 patient-years (95% CI 0-2.35) and major extracranial bleeding that required unplanned hospital admission was 1.84 events/100 patient-years (95% CI 0.25-3.43). A total of 28 (39.4%) patients died during this period with an annual mortality rate of 10.29 events/100 patient-years (95% CI 7.25-13.32). Our experience suggests that LAA occlusion using the Amulet device appears to be associated with a low risk of ischemic stroke in high-risk AF patients who are deemed unsuitable for oral anticoagulation; however, these patients have a high rate of mortality over the medium to long-term follow-up, and an ongoing significant risk of bleeding and thrombotic events.

Same-day discharge in selected patients undergoing atrial fibrillation ablation.

BACKGROUND: Atrial fibrillation (AF) ablation is a complex procedure, generally requiring at least one overnight hospital stay. We investigated the safety and feasibility of early mobilization and same-day discharge following streamlined peri-ablation management for AF. METHODS: From 2014, we offered same-day discharge to selected patients who underwent uncomplicated AF ablation on the morning lists, with ultrasound-guided femoral access, uninterrupted warfarin or minimal interruption in novel oral anticoagulants, and reversal of intraprocedural heparin with protamine. Patients were discharged 6-8 h postprocedure and offered access to a dedicated nurse helpline. RESULTS: Of 1599 AF ablation cases performed from April 2014 to March 2017, 811 (50.7%) were performed on the morning lists and 169/811 (20.8%) were discharged on the same day. Excluding 26 research cases, 1/143 (0.7%) had transient right phrenic nerve palsy and five (3.5%) cases experienced minor problems that did not preclude same-day discharge; three (2.1%) needed rehospitalization postdischarge: one for pericarditic chest pain and two for nausea/vomiting. Compared to 642 overnight cases, day-case procedures were shorter, more likely to be redos, to be performed under sedation rather than general anesthesia, and less likely to involve linear lesions and electrical cardioversion. There were no significant differences in patient age, gender, body mass index, CHA2 DS2 -VASc, in preprocedural anticoagulation regimen (warfarin vs novel anticoagulants vs no anticoagulation) and in choice of ablation method (cryoballoon vs radiofrequency). CONCLUSIONS: Selective same-day discharge after AF ablation is safe and feasible using a streamlined peri-procedural care protocol. Wider adoption can potentially reduce health-care costs while improving patient experience.

Electrical Storm: Current Evidence, Clinical Implications, and Future Perspectives.

PURPOSE OF REVIEW: Electrical storm (ES) is a life-threatening medical emergency of repetitive episodes of sustained ventricular arrhythmias within a short period. Its occurrence is associated with poor short- and long-term survival, even in patients with implantable cardioverter defibrillators (ICD). Management of ES is challenging and mainly based on retrospective studies. This article reviews the existing literature on ES, presents the available data regarding its management, and proposes a new algorithm based on current evidence. RECENT FINDINGS: Recent research could modify the management of ES supporting the role of non-selective ß1 and ß2 blockade and the early intervention with catheter ablation as well as strengthening the role of cardiac sympathetic denervation. A multipronged approach should be considered for the management of ES including identification and correction of reversible causes, ICD reprogramming, drug therapy (beta-blockers-especially non-selective ones-and other anti-arrhythmic drugs) and non-pharmacologic therapies such as catheter ablation and techniques of neuroaxial modulation. Although current data suggest early aggressive management, further research is required to clarify the optimal order and combination of therapies for the prevention of future events.

Management for atrial arrhythmias in adults with complex congenital heart disease.

INTRODUCTION: The prevalence of congenital heart disease (CHD) is steadily increasing among adults. Atrial arrhythmias are frequent late complications and are associated with substantial morbidity. AREAS COVERED: We discuss key considerations regarding management strategies for atrial arrhythmias in common forms of CHD and offer future perspectives. EXPERT OPINION: An appreciation of the types of atrial arrhythmias encountered in patients with diverse forms of CHD, combined with the growing clinical and research experience, appears to be yielding favorable results, whereas little progress has been made on the antiarrhythmic drug front, indications for anticoagulation have considerably evolved. Advances in interventional techniques have propelled catheter ablation to the forefront to treat a variety of atrial arrhythmias in patients with complex CHD. Nevertheless, much work remains to be done to elucidate underlying pathophysiology, triggers, and critical substrates that predispose patients with specific CHD malformations to develop atrial arrhythmias. Future advances could allow for the implementation of individualized, possibly preemptive, approaches to arrhythmia management. With the prevalence of atrial fibrillation on the rise in the aging population with CHD, concerted efforts must be directed toward optimizing patient selection for catheter ablation as well as refining procedural aspects to safely and more effectively improve long-term outcomes.

Robotic magnetic-guided catheter ablation in patients with congenital heart disease: a systematic review and pooled analysis.

BACKGROUND: Robotic magnetic navigation (RMN) has emerged as a potential solution to overcome challenges associated with catheter ablation of arrhythmias in patients with congenital heart disease (CHD). OBJECTIVES: To assess safety and efficacy of RMNguided catheter ablation in patients with CHD. DESIGN AND METHODS: A systematic review and pooled analysis was conducted on patients with CHD who underwent RMNguided catheter ablation. Random effects models were used to generate pooled estimates with the inverse variance method used for weighting studies. RESULTS: Twentyfour nonoverlapping records included 167 patients with CHD, mean age 36.5 years, 44.6% female. Type of CHD was simple in 27 (16.2%), moderate in 32 (19.2%), and complex in 106 (63.5%). A total of 202 procedures targeted 260 arrhythmias, the most common being macroreentrant atrial circuits. The mean procedural duration was 207.5 minutes, with a mean fluoroscopy time of 12.1 minutes. The pooled acute success rate was 89.2% [95% CI (77.8%, 97.4%)]. Freedom from arrhythmia recurrence was 84.5% [95% CI (72.5%, 94.0%)] over a mean follow-up of 24.3 months. The procedural complication rate was 3.5% with no complication attributable to RMN technology. CONCLUSION: RMN-guided ablation appears to be safe and effective across a variety of arrhythmia substrates and types of CHD.

Navigating Arrhythmias in Tetralogy of Fallot Throughout the Lifespan: A Case-based Review.

Arrhythmias are a common complication associated with tetralogy of Fallot (ToF), one of the most prevalent forms of congenital heart disease. As illustrated by this case-based review, various forms of arrhythmias can be encountered across the lifespan of patients with ToF, from infancy to older adulthood. These include atrioventricular block, junctional ectopic tachycardia, and atrial and ventricular arrhythmias. Arrhythmias have important implications on the health and quality of life of patients with ToF and require treatment by caregivers with dedicated expertise. The choice of pharmacologic and/or interventional therapies to alleviate symptoms, avoid complications, and mitigate risks depends in part on the type, severity, and frequency of the arrhythmia, as well as on the particularities of individual clinical scenarios. Preventing, monitoring for, and managing arrhythmias are an integral component of the care of patients with ToF throughout their lifespan that is critical to optimizing health outcomes.

L'arythmie est une complication fréquemment associée à la tétralogie de Fallot (TF), l'une des cardiopathies congénitales les plus courantes. Dans le présent article de synthèse basé sur des études de cas, nous illustrons les différentes formes d'arythmie tout au long de la vie des patients atteints de la TF, de la petite enfance à l'âge adulte avancé. Les formes d'arythmie décrites incluent le bloc atrioventriculaire, la tachycardie jonctionnelle ectopique et les arythmies auriculaire et ventriculaire. L'arythmie a des répercussions importantes sur l'état de santé et sur la qualité de vie des patients atteints de la TF, et elle requiert un traitement par des personnes dotées d'une expertise particulière. Le choix d'un traitement (pharmacologique, interventionnel ou les deux) pour soulager les symptômes, éviter les complications et réduire les risques dépend du type, de la sévérité et de la fréquence de l'arythmie, ainsi que des particularités de chaque tableau clinique. La prévention, la surveillance et la prise en charge de l'arythmie font partie intégrante des soins pour les patients atteints de la TF tout au long de leur vie, et elles sont cruciales pour optimiser les résultats cliniques.

Prevalence and clinical significance of collateral findings detected by chest computed tomography in patients undergoing atrial fibrillation ablation.

AIMS: Chest computed tomography (CT) scanning is increasingly used as an imaging technique in patients undergoing atrial fibrillation (AF) catheter ablation. Chest CT scans visualize organs other than the heart and collateral findings may be identified incidentally. Our study aims to assess the prevalence and clinical relevance of such collateral findings in patients undergoing AF ablation. METHODS AND RESULTS: One hundred and seventy-three patients (127 males, age 59 ± 10 years) underwent chest CT scan for image integration in AF ablation. Collateral findings from visualized thoracic and upper abdominal organs were collected. Findings that required further investigations or treatment according to current guidelines were considered as clinically significant. A total of 164 collateral findings were identified in 97 (56%) patients, and most patients showed abnormalities of the lungs (67 patients, 39%). Forty-nine (28%) patients had clinically significant findings needing further investigation and 17 (10%) of them required specific treatments, including three cases (1.7 %) of lung malignancy. CONCLUSIONS: Chest CT images acquired for integration in AF ablation should be read thoroughly as they may serve as a screening tool for otherwise unrecognized clinically significant conditions of the heart, lungs, or other visualized organs.

Reversible atrial gap junction remodeling during hypoxia/reoxygenation and ischemia: a possible arrhythmogenic substrate for atrial fibrillation.

Alteration of cardiomyocyte gap-junctions and component connexins (Cx) has been suggested to contribute to the development of atrial fibrillation (AF), including postoperative AF. We tested different possible stimuli, such as hypoxia and ischemia, influencing Cx43 and Cx40 expression and distribution in cultured atrial cells (HL-1) and reversibility of these processes after reoxygenation. Western-blot analysis and immunostaining using anti-Cx43, anti-Cx40 and anti-zonula occludens polyclonal antibodies were performed. HL-1 cells exposed to hypoxia for 24 and 48 h showed a reduction of Cx43 protein levels by 75% and 90% respectively (p < 0.001). During reoxygenation following 24 h of hypoxia, Cx43 levels increased to reach the basal level within 48 h, while they remained at low level during reoxygenation following 48 h of hypoxia. Furthermore, atrial cardiomyocytes subjected to simulated ischemia (SI) were incubated in normoxic and hypoxic conditions for 3, 6, 9, 12 h. Atrial cardiomyocytes subjected to SI in addition to normoxia showed a progressive reduction of Cx43 levels beginning from 3 h. During SI and hypoxia, atrial Cx43 levels showed an initial decrease after 3 h with a subsequent rescue beginning from 6 h of exposure (p = 0.001). Hypoxia and ischemia per se downregulate Cx43 protein expression in atrial cardiomyocytes, but protein downregulation is reversible, depending on hypoxia duration and the association of the two triggers. These alterations characterize several conditions and might contribute to the generation of an arrhythmogenic substrate leading to AF onset and/or maintenance.

Rationale and design of the NO-PARTY trial: near-zero fluoroscopic exposure during catheter ablation of supraventricular arrhythmias in young patients.

INTRODUCTION: Radiofrequency catheter ablation is the mainstay of therapy for supraventricular tachyarrhythmias. Conventional radiofrequency catheter ablation requires the use of fluoroscopy, thus exposing patients to ionising radiation. The feasibility and safety of non-fluoroscopic radiofrequency catheter ablation has been recently reported in a wide range of supraventricular tachyarrhythmias using the EnSite NavX™ mapping system. The NO-PARTY is a multi-centre, randomised controlled trial designed to test the hypothesis that catheter ablation of supraventricular tachyarrhythmias guided by the EnSite NavX™ mapping system results in a clinically significant reduction in exposure to ionising radiation compared with conventional catheter ablation. METHODS: The study will randomise 210 patients undergoing catheter ablation of supraventricular tachyarrhythmias to either a conventional ablation technique or one guided by the EnSite NavX™ mapping system. The primary end-point is the reduction of the radiation dose to the patient. Secondary end-points include procedural success, reduction of the radiation dose to the operator, and a cost-effectiveness analysis. In a subgroup of patients, we will also evaluate the radiobiological effectiveness of dose reduction by assessing acute chromosomal DNA damage in peripheral blood lymphocytes. CONCLUSIONS: NO-PARTY will determine whether radiofrequency catheter ablation of supraventricular tachyarrhythmias guided by the EnSite NavX™ mapping system is a suitable and cost-effective approach to achieve a clinically significant reduction in ionising radiation exposure for both patient and operator.

Imaging of scar in patients with ventricular arrhythmias of right ventricular origin: cardiac magnetic resonance versus electroanatomic mapping.

INTRODUCTION: Assessment of late gadolinium enhancement (LGE) at cardiac magnetic resonance is often used to detect scar in patients with arrhythmias of right ventricular (RV) origin. Recently, electroanatomic mapping (EAM) has been shown to reliably detect scars corresponding to different cardiomyopathic substrates. We compared LGE with EAM for the detection of scar in patients with arrhythmias of RV origin. METHODS AND RESULTS: Thirty-one patients with RV arrhythmias and biopsy-proven structural heart disease (18 ARVC and 13 myocarditis), and 5 with idiopathic RV outflow tract arrhythmias underwent LGE analysis and EAM with scar validation through EAM-guided endomyocardial biopsy. EAM scars were present in 23 (64%) patients (all with structural heart disease), whereas LGE was present only in 12 (33%). In 2 cases, EAM provided a false-positive diagnosis of a small scar in the basal perivalvular area. LGE correctly diagnosed EAM scar in 48% of patients, resulting in high positive (92%) but low negative (50%) predictive values. The distribution of LGE was significantly associated with the distribution of EAM scars (P < 0.001 in the free wall, P = 0.003 in the outflow tract, and P = 0.023 in the posterior/inferior wall). Presence of LGE reflected a higher extension of EAM scars (34.4 ± 16.5% vs 7.9 ± 10.1% of the RV area, P < 0.001). At receiver operating characteristic (ROC) analysis, an extension of scar ≥20% of the RV area was the best cut-off value to detect LGE (sensitivity 83%, specificity 92%). Of note, LGE missed 10 of 11 (91%) patients with EAM scars <20% of RV area. CONCLUSIONS: LGE is significantly less sensitive than EAM in identifying RV cardiomyopathic substrates. Absence of LGE does not rule out the presence of small scars, and EAM with biopsy should be considered to increase the diagnostic yield.

Meta-analysis: age and effectiveness of prophylactic implantable cardioverter-defibrillators.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) for the primary prevention of sudden cardiac death have been proven effective in several clinical trials. PURPOSE: To summarize evidence about the effectiveness of ICDs versus standard medical therapy for the primary prevention of sudden cardiac death in different age groups of patients with severe left ventricular dysfunction. DATA SOURCES: MEDLINE, Embase, CENTRAL, BioMed Central, Cardiosource, ClinicalTrials.gov, and ISI Web of Science (January 1970 to April 2010) were searched with no language restrictions. STUDY SELECTION: Two independent reviewers screened titles and abstracts to identify randomized, controlled trials of prophylactic ICD versus medical therapy in patients with severe left ventricular dysfunction that provided data about mortality outcomes for different age groups. DATA EXTRACTION: Two independent reviewers assessed risk for bias of trials and extracted patient and study characteristics and hazard ratios (HRs) relevant to all-cause mortality. DATA SYNTHESIS: Five trials (MADIT-II, DEFINITE, DINAMIT, SCD-HeFT, and IRIS) that enrolled 5783 patients (44% were elderly) were included. The primary analysis, which excluded the 2 trials enrolling patients early after acute myocardial infarction (DINAMIT and IRIS), found that prophylactic ICD therapy reduced mortality in younger patients (HR, 0.65 [95% CI, 0.50 to 0.83]; P < 0.001). A smaller survival benefit was found in elderly patients (HR, 0.75 [95% CI, 0.61 to 0.91]) that was not confirmed when MADIT-II patients older than 70 years were excluded or when data from DINAMIT and IRIS were included [corrected]. LIMITATIONS: Four potentially eligible trials were not included in the meta-analysis because mortality data by age group were not available. Adjustment for differences in comorbid conditions and medical therapies among patients enrolled in the trials was not possible. CONCLUSION: Available data suggest that prophylactic ICD therapy may be less beneficial for elderly patients with severe left ventricular dysfunction than for younger patients [corrected]. PRIMARY FUNDING SOURCE: None.

Usefulness of statins in preventing atrial fibrillation in patients with permanent pacemaker: a systematic review.

Patients with permanent pacemakers (PM) are at high risk of developing atrial fibrillation (AF). Minimal ventricular pacing modalities have been demonstrated to reduce AF in such patients, although they are not suitable for patients with advanced atrioventricular conduction disease. Recent evidences suggest that 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (i.e. statins) may represent a new strategy to prevent AF in patients at risk. In this article, we sought to review data regarding the effectiveness of statin therapy in preventing AF patients with a PM. We reviewed all available studies that assessed the effect of statin therapy on the occurrence of AF in patients with PM, implanted due to sinus node dysfunction or atrioventricular conduction disease. Moreover, a random effect inverse variance-weighted meta-analysis was performed, by entering directly the logarithm of the hazard ratio (HR) of AF provided in the multiple Cox regression analyses from each study. Three studies were identified, including 552 patients, of whom 159 received statins. Follow-up ranged from 1 to 2.77 years. Two studies (one observational and one prospective randomized) included predominantly patients with sinus node dysfunction (70% and 91% of patient population, respectively) and, consistently, showed a beneficial effect of statins on the occurrence of AF. On the other hand, the study including predominantly patients with atrioventricular block (60% of patient population) failed to show a beneficial effect of statins on AF occurrence. The HR for AF occurrence for the cumulative data was found to be 0.43 (95% confidence interval: 0.28-0.67, P < 0.001). Statistical heterogeneity between included studies was not detected (chi(2) = 1.68, P = 0.43, I(2) = 0%), although significant clinical differences were found in terms of study design, patient populations, statins use and dosage and AF-monitoring capabilities. Statins may represent a novel treatment strategy to prevent the occurrence of AF in patients with PM, especially for those who had a PM implanted due to sinus node dysfunction. Basing on our findings, a randomized clinical trial with a proper design to evaluate the utility of statins in preventing AF in these patients is warranted.

Neuroimaging findings in pediatric Wernicke encephalopathy: a review.

Wernicke encephalopathy (WE) is an acute neurological disease resulting from dietary thiamine (vitamin B1) deficiency. WE is characterized by changes in consciousness, ocular dysfunction, and ataxia. Neuroradiologic findings usually show symmetric signal intensity alterations in the mammillary bodies, medial thalami, tectal plate, and periaqueductal area. Selective involvement of the cranial nerve nuclei, cerebellum, red nuclei, dentate nuclei, fornix, splenium, cerebral cortex, and basal ganglia characterize nonalcoholic WE patients. Furthermore, symmetric basal ganglia alterations with involvement of the putamen have only been observed in children. The incidence of WE is underestimated in both adult and pediatric patients. Interestingly, the frequency of WE in children appears to be similar to that observed in adults. The prognosis of the disease largely depends on the time from diagnosis to thiamine supplementation. The aim of this pediatric literature review is to provide an update on neuroradiologic findings in children affected by WE in an effort to determine pertinent clinical and imaging findings that can improve the detection and early identification of the disease. A thorough knowledge of the MRI findings of WE will assist in arriving at an early diagnosis, thereby reducing the morbidity and mortality associated with this disease in children.

Acute spinal cord compression due to epidural lipomatosis complicated by an abscess: magnetic resonance and pathology findings.

A 68-year-old male presented with rapidly progressive paraplegia. MR images of the thoracic spine were interpreted as being consistent with an abscess within an epidural lipomatosis compressing the spinal cord. Laminectomy was performed, and a large amount of pus was drained from the epidural lipomatosis, from which Staphylococcus aureus was isolated. This is the first reported case of an abscess involving an epidural lipomatosis.

Long-Term Arrhythmic Risk Assessment in Biopsy-Proven Myocarditis.

OBJECTIVES: This study sought to assess long-term arrhythmic risk in patients with myocarditis who received an implantable cardioverter-defibrillator (ICD). BACKGROUND: The arrhythmic risk of patients with myocarditis overtime remains poorly known. METHODS: The study enrolled 56 patients with biopsy-proven myocarditis who received an ICD for either primary (57%) or secondary prevention (43%) according to current guidelines. Clinical characteristics, biopsy findings, electrophysiological data from endocardial 3-dimensional electroanatomic voltage mapping, and device interrogation data were analyzed to detect arrhythmic events overtime. Coronary angiography excluded significant coronary artery disease in all patients. RESULTS: At a mean follow-up of 74 ± 60 months (median 65 months), 25 (45%) patients had major ventricular arrhythmias treated by ICD intervention (76% being terminated by ICD shock and 24% by antitachyarrhythmia burst pacing). At multivariable analysis, the presence of sustained ventricular tachycardia on admission (hazard ratio: 13.0; 95% confidence interval: 2.0 to 35.0; p = 0.032) and the extension of the areas of low potentials at the bipolar endocardial mapping (hazard ratio: 1.19; 95% confidence interval: 1.04 to 1.37; p = 0.013) were the only independent predictors of appropriate ICD interventions. A cutoff value of 10% of abnormal bipolar area at electroanatomical ventricular mapping discriminated patients with appropriate ICD interventions with a sensitivity of 89% and a specificity of 85%. CONCLUSIONS: The study demonstrates that the prevalence of life-threatening ventricular arrhythmias in patients with myocarditis receiving an ICD according to current guidelines is high and the arrhythmic risk persists late overtime. Electroanatomical ventricular mapping may be a useful tool to identify patients at greater arrhythmic risk.

Ventricular tachycardia ablation in structural heart disease: Impact of ablation strategy and non-inducibility as an end-point on long term outcome.

BACKGROUND: To investigate the long term outcomes after catheter ablation (CA) of ventricular tachycardia (VT) in the context of structural heart disease in a multicenter cohort. The impact of different ablation strategies (substrate ablation versus activation guided versus combined) and non-inducibility as an end-point was evaluated. METHODS: Data was pooled from prospective registries at 5 centres over a 5 year period. Success was defined as survival free from recurrent ventricular arrhythmias (VA). Multivariate analysis of factors predicting survival free from VA was analysed by Cox regression. RESULTS: Five hundred sixty-six patients underwent CA for VT. Patients were 64 ±â€¯15 years. Left ventricular ejection fraction was 35 ±â€¯15% and 66% had ischaemic heart disease. At 2.3 (IQR 1.0-4.2) years, success was achieved in 44% after a single procedure, rising to 60% after repeat procedures. Mortality at final follow up was 22%. Multivariate analysis showed that higher left ventricular ejection fraction, younger age, ischaemic heart disease, and non-inducibility of VA predicted long term survival free from VA (all p < 0.05). There was no impact of the approach to ablation. CONCLUSION: CA eliminates VT in a large proportion of patients long term. Ablation strategy did not impact outcome and hence substrate ablation is a reasonable initial strategy. Non-inducibility of VA predicted survival free from VA and may be worth pursuing as a procedural end-point.

Outcome of left atrial appendage occlusion in high-risk patients.

OBJECTIVE: Percutaneous left atrial appendage (LAA) occlusion can be an interventional alternative to oral anticoagulation for stroke prevention in patients with atrial fibrillation. METHODS: We delivered LAA occlusion therapy using a standardised approach to patient referral, multidisciplinary team assessment, implant criteria, imaging and follow-up. We analysed patient characteristics, efficacy and safety of the implant procedure, and 12-month outcomes. RESULTS: Of 143 referrals from October 2014 to December 2016, 83 patients (age 76±8years, 32.5% female, mean CHAD2S2-VASc score 4 ±1) were offered LAA occlusion. Eighty (95.3%) had previous major bleeding (intracranial in 59%). LAA occluder implantation with an Amulet device was successful in 82 (98.8%), with periprocedural major adverse events occurring in 5 (6.0%) patients (2 device embolisations including 1 death, 2 major bleeds). Cardiac imaging in 75 (94%) patients 2months following implant showed device-related thrombus in 1 case (1.3%) and minor (<5mm) device leaks in 13 (17.1%). Over a median 12-month follow-up, 3 (3.8%) ischaemic strokes, 2 (2.5%) haemorrhagic strokes and 5 (6.3%) major extracranial bleeds occurred. All-cause mortality was 10%, with most deaths (7, 87.5%) due to non-cardiovascular causes. CONCLUSIONS: LAA occlusion may be a reasonable option for stroke prevention inhigh-risk patients with atrial fibrillation ineligible for anticoagulation. However, procedural complication rates are not insignificant, and patients remain at risk of serious adverse events and death even after successful implant.