Embolization of percutaneous left atrial appendage closure devices: timing, management and clinical outcomes.

BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.

Length of stay following percutaneous left atrial appendage occlusion: Data from the prospective, multicenter Amplatzer Amulet Occluder Observational Study.

AIMS: To evaluate factors influencing the length of stay in patients undergoing percutaneous left atrial appendage occlusion (LAAO). METHODS AND RESULTS: Patient characteristics, procedural data and the occurrence of serious adverse events were analyzed from the AmplatzerTM AmuletTM Occluder Observational Study. Patients were divided into three groups: same day (S, 0day, n = 60, 5.6%) early (E, 1day, n = 526, 48.9%), regular (R, 2-3days, n = 338, 31.4%) and late (L, ≥4days, n = 152, 14.1%) discharge and followed up for 60 days. Procedure and device related SAE during the in-hospital stay (S: 0.0% vs. E: 1.0% vs. R: 2.1% vs. L: 23%, p<0.0001) were a major trigger for a prolonged in-hospital stay. Of the 37 subjects in the late discharge group with an SAE prior to discharge, cardiac or bleeding complications were the most common underlying conditions, occurring in 26 subjects. Multinomial logistic analysis only identified HAS-BLED score as an independent influencing factor (p = 0.04) for a late discharge. After 60 days, mortality tended to be greatest in the late discharge group (S: 0.0% vs. E: 1.0% vs. R: 1.2% vs. L: 3.3%, p = 0.1066). CONCLUSION: Over half of the subjects receiving an Amplatzer Amulet occluder were discharged within 1 day of the implant procedure. Serious adverse events were a major trigger for a late discharge after LAAO. Increased HAS-BLED score was associated with a prolonged in-hospital stay.

Gender difference in left atrial appendage occlusion outcomes: Results from the Amplatzer™ Amulet™ Observational Study.

BACKGROUND: Percutaneous LAAO represents an alternative for stroke prevention in patients not tolerating anticoagulation. While women are at higher risk of complications during percutaneous coronary or valvular interventions, the impact of gender on LAAO outcomes is not well characterized. The current study assessed potential gender-related differences in procedural and long-term outcomes following left atrial appendage occlusion (LAAO). METHODS: 1088 AF patients were enrolled in the prospective, multicenter, Amplatzer™ Amulet™ Observational Study and followed for 2 years with scheduled adverse event assessments. The prespecified primary outcome was ischemic stroke, systemic embolism or cardiovascular (CV) death at 2 years. We also compared the rate of procedural success, device-related thrombus (DRT) and major bleeding between genders. RESULTS: 702 men and 386 women underwent LAAO. Implant successwas high, and similar between men and women (98.9 vs 99.5%, p = 0.58). Similarly, no difference was observed in the primary outcome (12.0 vs 12.5%, p = 0.82). Compared to the CHA2DS2-VASc predicted rate, we observed a numerically greater absolute risk reduction of ischemic stroke in women (from 7.6 to 2.1%/year) than men (from 6.2 to 2.2%/year). DRT through 2 years was similar between groups (1.6%, p = 0.96). We found no significant gender difference in terms of periprocedural or long-term (7.1 vs 7.6%/year) major bleeding. CONCLUSIONS: In this large group of patients undergoing LAAO using the Amplatzer™ Amulet™ device we found no significant gender difference in terms of procedural or long-term clinical outcomes. Similarly to oral anticoagulation, device-based LAA occlusion renders AF-related stroke risk similar in women and men. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02447081.https://clinicaltrials.gov/ct2/show/NCT02447081.

Clinical outcomes of patients undergoing percutaneous left atrial appendage occlusion in general anaesthesia or conscious sedation: data from the prospective global Amplatzer Amulet Occluder Observational Study.

OBJECTIVE: To evaluate the safety and efficacy of percutaneous left atrial appendage occlusion (LAAO) using conscious sedation (CS). BACKGROUND: Several percutaneous structural heart disease interventions are safely and efficiently performed using CS instead of general anaesthesia (GA). This concept has not been evaluated in a large multicenter cohort of patients undergoing LAAO. METHODS: Patients from the prospective, global Amplatzer Amulet Occluder Observational Study were divided into two groups (GA vs CS). Baseline information, periprocedural and postprocedural efficacy and complications, as well as outcomes through 7 days post implant were compared. RESULTS: Patients undergoing transesophageal-guided implants were categorised by GA (n=607, 64%) or CS (n=342, 36%) usage. Mean age was 75 years in both groups. LAAO technical success was achieved in 99% of both groups. The procedure duration (GA: 35±22 min vs CS: 27±19 min, p<0.001), total amount of contrast medium (GA: 105±81 mL vs CS: 86±66 mL, p<0.001) and fluoroscopic time (GA: 13±9 min vs CS: 12±13 min, p<0.001) were less in CS cases. Procedure-related or device-related serious adverse events during the first 7 days were numerically higher in the CS group (GA: 4.9% vs CS: 7.6%, p=0.114). Peridevice residual flow was absent or ≤5 mm 1-3 months after the procedure in 99.7% of the GA and in 100% of the CS group (p=1.000). CONCLUSIONS: In a large global study, LAAO with the Amplatzer Amulet occluder is safe and feasible using CS. Procedure duration and total amount of contrast were less with CS than GA cases. TRIAL REGISTRATION NUMBER: NCT02447081; Results.

Incidence and clinical impact of major bleeding following left atrial appendage occlusion: insights from the Amplatzer Amulet Observational Post-Market Study.

BACKGROUND: Major bleeding (MB) events are independent predictors of mortality after cardiac interventional procedures. The clinical relevance of MB following left atrial appendage occlusion (LAAO) remains unclear. AIMS: This study aimed to investigate the incidence and clinical impact of MB after LAAO in a real-world population at high risk for bleeding and contraindicated to anticoagulation. METHODS: The two-year results of the Amplatzer Amulet Observational Post-Market Study were analysed. An independent committee adjudicated MBs according to the Bleeding Academic Research Consortium scale. Cox proportional hazards regression identified variables associated with MB events and mortality. RESULTS: The MB rate was 7.2%/year, with a rate of 10.1%/year during year one, decreasing to 4.0%/year over year two. The most common bleeding location was gastrointestinal, accounting for 48% of MBs. Pre-LAAO MB was associated with an increased risk for post-LAAO MB (HR 2.34, 95% CI: 1.37-3.99). The occurrence of post-LAAO MB was associated with increased mortality (37.3% vs 12.7%; p<0.0001), driven mainly by events occurring beyond the periprocedural period. The annualised rate of ischaemic stroke or TIA was similar in patients with and without MB (2.3% vs 3.3%; p=0.446). MB post LAAO was a strong independent predictor of mortality (HR 3.07, 95% CI: 2.15-4.40). CONCLUSIONS: In real-world patients at high bleeding risk, MB following LAAO was not uncommon and associated with a significant increase in mortality, without increasing the risk of stroke. ClinicalTrials.gov Identifier: NCT02447081. https://clinicaltrials.gov/ct2/show/NCT02447081.

Three two-site apoA-I immunoassays using phage expressed detector antibodies - Preliminary clinical evaluation with cardiac patients.

High density lipoproteins (HDL) are a heterogenous group of subpopulations differing in protein/lipid composition and in their anti-atherogenic function. There is a lack of specific and robust assays which can target the functionality of HDL with respect to atherosclerosis. With recently generated CAD HDL targeted, single chain recombinant antibodies (scFvs) we set out to design and optimize apo A-I tests to compare it with conventional HDL-C and apo A-I analyses for diagnosis and risk assessment of coronary artery disease (CAD) and its outcome. Three highly sensitive two-site apo A-I assays: 022-454, 109-121 and 110-525 were optimized. A preliminary clinical evaluation of these assays, after proper sample dilution procedure, was performed using samples derived from 195 chest pain patients (myocardial infarction (MI), n = 86 and non-MI, n = 109), collected at the time of admission and at discharge from hospital (hospital stay ≤ 24 h). The clinical performance of the assays was compared with apo A-I measured with polyclonal anti-apo A-I antibody using conventional ELISA. Apo A-I data was in addition compared with HDL-C concentration of the samples. The concentration of apo A-I was significantly lower in MI patients than in non-MI individuals with assay 022-454 (admission and discharge samples, P < 0.0001 and = 0.004); assay 109-121 (admission and discharge samples, P = 0.04 and 0.0009), and, ELISA based apo A-I test (admission and discharge samples, P = 0.008 and < 0.0001). HDL-C (admission and discharge samples, P = 0.002 and P = 0.01) was also significantly lower in MI patients. In Kaplan- Meier analysis, two-site assay 109-121 assay predicted mortality from admission samples at 1.5 yrs (whole cohort, P = 0.01 and in MI patients, P = 0.05) and at 6 months (whole cohort, P = 0.04). Assay 110-525 predicted mortality at 1.5 yrs from admission samples of non-MI patients (P = 0.01) and at 6 months from whole discharge sample cohort (P = 0.04). Polyclonal anti-apo A-I based conventional assay predicted mortality at 1.5 yrs from admission samples of whole cohort (P = 0.03). Two-site apo A-I assay 022-454 and HDL-C provided no capability of predicting mortality in the whole cohort or any sub-group. In conclusion, two of the tested recombinant apo A-I antibody combinations (sc 109-121 and sc 110-525) display promising outcome to improve diagnosis and prediction of future cardiac events in cardiac patients over polyclonal apo A-I ELISA and HDL-C assays. The noted differences, while interesting, are preliminary and need however to be verified in extensive cohorts of pathological cardiac conditions and healthy controls.

Comparative data on left atrial appendage occlusion efficacy and clinical outcomes by age group in the Amplatzer™ Amulet™ Occluder Observational Study.

AIMS: Left atrial appendage occlusion (LAAO) may be considered for patients with non-valvular atrial fibrillation (NVAF) and a relative/formal contraindication to anticoagulation. This study aimed to summarize the impact of aging on LAAO outcomes at short and long-term follow-up. METHODS AND RESULTS: We compared subjects aged <70, ≥70 and <80, and ≥80 years old in the prospective, multicentre Amplatzer™ Amulet™ Occluder Observational Study (Abbott, Plymouth, MN, USA). Serious adverse events (SAEs) were reported from implant through a 2-year post-LAAO visit and adjudicated by an independent clinical events committee. Overall, 1088 subjects were prospectively enrolled. There were 265 subjects (24.4%) <70 years old, 491 subjects (45.1%) ≥70 and <80 years old, and 332 subjects (30.5%) ≥80 years old, with the majority (≥80%) being contraindicated to anticoagulation. As expected, CHA2DS2-VASc and HAS-BLED Scores increased with age. Implant success was high (≥98.5%) across all groups, and the proportion of subjects with a procedure- or device-related SAE was similar between groups. At follow-up, the observed ischaemic stroke rate was not significantly different between groups, and corresponding risk reductions were 62, 56, and 85% when compared with predicted rates for subjects <70, ≥70 and <80, and ≥80 years old, respectively. Major bleeding and mortality rates increased with age, while the incidence of device-related thrombus tended to increase with age. CONCLUSIONS: Despite the increased risk for ischaemic stroke with increasing age in AF patients, LAAO reduced the risk for ischaemic stroke compared with the predicted rate across all age groups without differences in procedural SAEs.

The Impact of CHA2DS2-VASc and HAS-BLED Scores on Clinical Outcomes in the Amplatzer Amulet Study.

OBJECTIVES: The aim of this study was to evaluate the impact of CHA2DS2-VASc and HAS-BLED scores on ischemic and bleeding events of patients enrolled in the Amplatzer Amulet Observational Study. BACKGROUND: Baseline CHA2DS2-VASc and HAS-BLED scores have been validated in atrial fibrillation patients to guide about anticoagulation but not in patients treated by left atrial appendage occlusion (LAAO). METHODS: Subjects were stratified according to CHA2DS2-VASc and HAS-BLED scores. Clinical outcomes were collected through 2 years and adjudicated by an independent committee. RESULTS: Subjects were considered at low (n = 156), moderate (n = 715), and high (n = 215) risk for ischemic stroke, corresponding to CHA2DS2-VASc scores of <3, 3 to 5, and ≥6, respectively. The annual rates of ischemic stroke were 1.1%, 2.0%, and 3.5%, respectively. When compared with the predicted rate, LAAO reduced the risk of ischemic stroke by 56%, 69%, and 68%. Device-related thrombus occurred in 0.7%, 1.5%, and 3.0% of subjects at low, moderate, and high risk for ischemic stroke, respectively. The HAS-BLED score was ≤3 in 629 subjects and >3 in 456 subjects, respectively. Non-peri-procedural major bleeding was reduced by 11% and 9% compared with predicted rates in the low and high bleeding risk groups, respectively. CONCLUSIONS: LAAO with the Amplatzer Amulet reduced the risk of ischemic stroke compared with the predicted rate, with a greater magnitude among patients at high thromboembolic risk without increasing the bleeding risk. (Amplatzer™Amulet™ Post-Market Study [Amulet™PMS]; NCT02447081).

Percutaneous left atrial appendage closure in patients with prior intracranial bleeding and thromboembolism.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is an alternative treatment in atrial fibrillation patients with contraindication to oral anticoagulation. However, patient selection criteria for LAAC are debated. OBJECTIVE: The purpose of this study was to evaluate the outcome after LAAC in patients with prior intracranial bleeding and thromboembolism. METHODS: Consecutive patients with atrial fibrillation and prior intracranial bleeding who underwent LAAC from February 2009 to August 2018 at the Turku University Hospital, Finland, were included in a prospective registry. Patients were followed through clinical visits and annual phone calls up to 5 years. RESULTS: Overall 104 patients (mean age 73 ± 7 years; 30% women; CHA2DS2-VASc score 4.7 ± 1.4; HAS-BLED score 3.3 ± 0.9) with atrial fibrillation and prior intracranial bleeding underwent successful LAAC using mainly (n = 102) Amplatzer devices. Median time from intracranial bleeding to LAAC was 7 months, and median follow-up 3.6 years. Antithrombotic treatment was ≤6 months in 71 patients (68%), and 48 patients (46%) received aspirin or clopidogrel alone. The rates of thromboembolism and intracranial bleeding (per 100 patient-years) were 3.4 and 1.9, respectively. In 39 patients with previous thromboembolism, the rate of thromboembolism was 3.6 per 100 patient-years (95% confidence interval 1.5-7.0), yielding a 69% relative risk reduction with respect to predicted risk based on median CHA2DS2-VASc score. Overall, rates of thromboembolism and intracranial bleeding were broadly similar in patients with and those without prior thromboembolism. CONCLUSION: Percutaneous LAAC with minimized antithrombotic treatment was demonstrated to be a valid treatment option in high-risk patients with prior intracranial bleeding and thromboembolism.

Ablation strategies for different types of atrial fibrillation in Europe: results of the ESC-EORP EHRA Atrial Fibrillation Ablation Long-Term registry.

AIMS: The ESC EORP EHRA Atrial Fibrillation (AF) Ablation Long-Term registry was designed to assess management and outcomes of AF catheter ablation procedures in Europe. To investigate the current ablation approaches and their outcomes for patients with paroxymal AF (PAF) and non-PAF in Europe. METHODS AND RESULTS: Data from index ablations were collected in 27 European countries at 104 centres in a prospective fashion. Pre-procedural, procedural, and 1-year follow-up data were captured on a web-based electronic case record form. Data on the ablation procedure were available for 3446 patients. Of these, 2513 patients and 933 patients underwent pulmonary vein isolation (PVI) or PVI plus (PVIplus) additional ablation, respectively. The ablation strategy was limited to PVI in 81% and 56% of patients in the PAF and non-PAF group, respectively (P < 0.001). In the non-PAF group, left atrial linear ablation and ablation of complex fragmented atrial electrograms were more commonly performed. Arrhythmias recurrence after PVI was 29% and 39% in the PAF and non-PAF group, respectively (P < 0.001) and 42% after PVIplus in both groups. Atrial fibrillation related hospital admissions were more common in the PVIplus group (20% vs. 14%). A very low procedural complication rate was observed. No relevant differences were observed with regard to repeat ablation (PVI 9% and PVIplus 11%). CONCLUSION: In patients with PAF and non-PAF, the ablation strategies of PVI and PVIplus led to similar arrhythmia-free survival rates after 1 year. A considerable hospital readmission rate was noted.

Effectiveness of Only Aspirin or Clopidogrel Following Percutaneous Left Atrial Appendage Closure.

Percutaneous left atrial appendage closure (LAAC) offers a feasible option for stroke prevention in patients with atrial fibrillation (AF), but the optimal antithrombotic treatment strategy for patients with strict contraindications to oral anticoagulation (OAC) remains uncertain. We sought to evaluate short- and long-term outcome after percutaneous LAAC in these very patients discharged on single antiplatelet therapy (SAPT) alone. All consenting AF patients who underwent LAAC from February 2009 to August 2018 in Turku University Hospital, Finland, were enrolled into a prospectively maintained registry. Only patients discharged on SAPT alone were considered for the present analysis. Patients were prospectively followed up to 5 years. The primary end points were thromboembolic event (stroke, transient ischemic attack, or systemic embolism) and intracranial bleeding. Of the 165 LAAC patients, 81 patients (mean age 75 ± 7 years; 44% women; CHA2DS2-VASc 4.8 ± 1.4; HAS-BLED 3.2 ± 0.8) were discharged on SAPT only (77 with aspirin 100 mg) after successful LAAC using Amplatzer devices. The duration of SAPT was ≤6 months in 61 (75%) patients. The most common contraindication to OAC was previous intracranial bleeding in 48 (59%) patients. During a mean follow-up of 2.9 years, there were 6 thromboembolic events (2.7 of 100 patient-years; 73% lower-than-predicted rate of thromboembolism). Eight patients (3.6 of 100 patient-years) had a major bleeding event after discharge, and 4 patients had intracerebral bleeding (1.7 of 100 patient-years). At 6-month landmark analysis, freedom from thromboembolism and intracranial bleeding at 3-year follow-up was similar in those with discontinued and life-long SAPT (95.1% vs 88.9% and 97.6% vs 91.7%, respectively). In conclusion, long-term outcome is satisfactory after LAAC in selected AF patients with strict contraindications to OAC receiving short-term SAPT. However, adverse events are not infrequent during early postoperative months.

Incidence, Characterization, and Clinical Impact of Device-Related Thrombus Following Left Atrial Appendage Occlusion in the Prospective Global AMPLATZER Amulet Observational Study.

OBJECTIVES: This study sought to report the incidence, characteristics, and clinical impact of device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) with the AMPLATZER Amulet device (Abbott, Plymouth, Minnesota). BACKGROUND: DRT is a potential serious complication of LAAO, but the incidence and clinical impact of DRTs in a real-world setting are not well characterized. METHODS: A total of 1,088 patients were enrolled in a multicenter prospective study and followed for 1 year. All events were adjudicated by an independent committee, including the presence of DRT. Patients with DRT were reviewed for suboptimal device implantation and characterization of DRT formation. Multiple Cox regression was performed to identify predictors of DRT formation. RESULTS: Device implantation was successful in 1,078 (99%) patients, with 1-year follow-up completed in 96.3% of patients. A total of 18 DRTs occurred in 17 patients (1.7%/year), as a second DRT developed following complete resolution of an initial DRT in 1 patient. The left upper pulmonary vein ridge was not covered by the Amulet disc in 82% of DRT patients, indicating suboptimal implantation, with most thrombus developing in the untrabeculated area of the LAA ostium between the pulmonary vein ridge and the upper edge of the disc. Three (18%) DRT patients had an ischemic stroke, all within 3 months of DRT diagnosis. Patients with a DRT were at a greater risk for ischemic stroke or transient ischemic attack compared with non-DRT patients (hazard ratio: 5.27; 95% confidence interval: 1.58 to 17.55; p = 0.007). Larger LAA orifice width was a predictor of DRT formation (hazard ratio: 1.09; 95% confidence interval: 1.00 to 1.19; p = 0.04). CONCLUSIONS: Following LAAO with the AMPLATZER Amulet device, DRT was observed infrequently. Although the presence of DRT was associated with an increased rate of ischemic stroke or transient ischemic attack as compared with patients without DRT, the large majority of DRT patients (82%) did not experience any ischemic neurologic events.

Direct Immunoassay for Free Pregnancy-Associated Plasma Protein A (PAPP-A).

BACKGROUND: Pregnancy-associated plasma protein A (PAPP-A), especially in its noncomplexed form (fPAPP-A), is linked to vulnerable atherosclerotic plaques and risk of cardiac events. An assay for sensitive detection of fPAPP-A has been lacking. Our aim was to develop and validate a direct fPAPP-A assay to meet this need. METHODS: Monoclonal antibodies binding exclusively fPAPP-A were produced by immunizing mice with recombinant PAPP-A. In the optimized immunoassay, we used an fPAPP-A-specific capture antibody together with a lanthanide-chelate-labeled monoclonal antibody recognizing all PAPP-A forms. The assay was evaluated with CLSI guidelines and compared to a 2-assay subtractive fPAPP-A approach. Clinical performance was assessed with acute coronary syndrome patients. RESULTS: The limits of detection and quantitation were 0.4 mIU/L and 1.3 mIU/L, respectively, and the assay was linear up to 1000 mIU/L (R2 = 0.999). Both serum and heparin plasma were suitable matrices, and the complexed form of PAPP-A caused no significant interference. Correlation between the developed assay and the 2-assay approach was fair (Pearson's r = 0.819). Median concentration in healthy individuals was 1.0 mIU/L. fPAPP-A concentration was higher in patients who had myocardial infarction or died during the 1-year follow-up period than in those who did not (1.13 mIU/L vs 0.82 mIU/L, P = 0.008, model adjusted with age and sex). fPAPP-A measured with this direct assay predicted this end point as well as (follow-up 1 year) or better (30 days) than the 2-assay fPAPP-A alone or in combination with cTnI. CONCLUSIONS: The new assay enables sensitive and reliable measurement of low cardiac-related fPAPP-A concentrations from blood samples.

Antiarrhythmic drug therapy among patients presenting to emergency department with symptomatic atrial fibrillation - a prospective nationwide cohort.

BACKGROUND: Atrial fibrillation (AF) is a common arrhythmia that causes numerous visits to emergency departments (ED). The aim of the FinFib2 study was to evaluate whether treatment of patients with AF in ED is consistent with the contemporary European Society of Cardiology (ESC) management guidelines. Here we report the results of antiarrhythmic drug therapy (AAD) in ED. METHODS: All patients within the two-week study period whose primary reason for the ED visit was symptomatic AF were included into this prospective multicentre study. Comprehensive data on factors contributing to the treatment of AF were collected, including a data of previous use of ADDs, and changes made for them during a visit in ED. RESULTS: The study population consisted of 1013 consecutive patients (mean age 70 ± 13 years, 47.6% female). The mean European Heart Rhythm Association (EHRA) symptom score was 2.2 ± 0.8. Rhythm control strategy was opt for 498 (63.8%) and 140 (64.5%) patients with previously and newly diagnosed AF, respectively. In patients with previously diagnosed AF the most frequently used AAD was a beta blocker (80.9%). Prior use of class I (11.4%) and III (9.1%) AADs as well as start or adjustment of their dosage (7.4%) were uncommon. Most of the patients with newly diagnosed AF were prescribed a beta blocker (71.0%) or a calcium channel antagonist (24.0%), and only two of them received class I or class III AADs. CONCLUSIONS: Our data demonstrated that in patients presenting to the ED with recurrent symptomatic AF and aimed for rhythm control strategy, the use of class I and class III AADs was rare despite ESC guideline recommendations. It is possible that early adaptation of a more aggressive rhythm control strategy might improve a quality of life for symptomatic patients and alleviate the ED burden associated with AF. Beta blockers were used by majority of patients as rate control therapy both in rate and rhythm control groups. TRIAL REGISTRATION: NCT01990105 . Registered 15 November 2013.

Left atrial appendage occlusion with the AMPLATZER Amulet device: periprocedural and early clinical/echocardiographic data from a global prospective observational study.

AIMS: The global, prospective AMPLATZER Amulet observational study documents real-world periprocedural, transoesophageal echocardiographic (TEE) and clinical outcomes from left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device. The aim of this report is to describe the periprocedural and early clinical/TEE results from this study. METHODS AND RESULTS: This multicentre prospective real-world registry included 1,088 patients (75±8.5 years, 64.5% male, CHA2DS2-VASc: 4.2±1.6, HAS-BLED: 3.3±1.1) with non-valvular atrial fibrillation; 82.8% of patients were considered to have an absolute or relative contraindication to long-term anticoagulation and 72.4% had had a previous major bleeding. Periprocedural results, clinical outcomes up to the first three months and the available TEE results from the first scheduled follow-up (one to three months post implant) are reported. Successful device implantation was achieved in 99.0% of patients. During the procedure and index hospitalisation, major adverse events occurred in 3.2% of patients. Patients were discharged on a single antiplatelet agent (23.0%), dual antiplatelets (54.3%) or an oral anticoagulant (18.9%). TEE follow-up 67±23 days post procedure in 673 patients showed adequate (<3 mm jet) occlusion of the appendage in 98.2% of patients and device thrombus in 10 patients (1.5%), as evaluated by core laboratory analysis. CONCLUSIONS: This large real-world prospective registry of catheter-based LAAO using the AMPLATZER Amulet device reports a high implant success rate and a low periprocedural complication rate in a population with a high risk of stroke and bleeding. Transoesophageal echo data confirm good closure rates during follow-up and low rates of device-associated thrombus.

Left atrial appendage occlusion versus standard medical care in patients with atrial fibrillation and intracerebral haemorrhage: a propensity score-matched follow-up study.

AIMS: The aim of this study was to investigate the prognosis in patients with atrial fibrillation (AF) and intracerebral haemorrhage (ICH) having a left atrial appendage occlusion (LAAO) versus patients receiving standard medical therapy. METHODS AND RESULTS: A total of 151 patients from the Nordic countries with AF and previous ICH who underwent LAAO using the AMPLATZER Cardiac Plug or the AMPLATZER AMULET were compared to a propensity score-matched group of 151 patients receiving standard medical therapy. The two groups were matched so that their risks for stroke and bleeding were similar (CHA2DS2-VASc and HAS-BLED scores). The standard care patients were identified from the Danish Stroke Registry among 787 patients with AF and ICH. The primary endpoint was a composite of all-cause mortality, ischaemic stroke and major bleeding. Patients with AF and a prior ICH treated with LAAO had a lower risk of the composite outcome as compared to patients treated with standard medical care (events/1,000 years [95% confidence interval]: 53.3 [44.3-64.1] vs. 366.7 [298.2-450.9]; hazard ratio 0.16 [0.07-0.37]). CONCLUSIONS: LAAO is suggested to be of major clinical benefit in AF patients having sustained an ICH. These results have to be confirmed in a randomised clinical trial.

Anticoagulation therapy among patients presenting to the emergency department with symptomatic atrial fibrillation - the FinFib2 study.

OBJECTIVES: Atrial fibrillation (AF) causes numerous visits to emergency departments (EDs). We evaluated the thromboembolic and bleeding risk profile and use of oral anticoagulation (OAC) therapy among patients presenting with symptomatic AF to ED. METHODS: Within a 2-week period, all patients whose primary reason for the ED visit was AF were enrolled into this prospective study in 35 EDs around Finland. The risk of thromboembolic and bleeding events was assessed by the CHA2DS2VASc and the HAS-BLED score, respectively. Thereafter, we evaluated whether OAC was used according to the contemporary management guidelines. RESULTS: The study population included 1013 patients (mean age 70±13 years, 52.4% men) with newly or previously diagnosed symptomatic AF. The mean CHA2DS2VASc and HAS-BLED score was 3.1±2.1 and 1.9±1.2, respectively. At admission, 76.3% of the patients with previously diagnosed AF and CHA2DS2VASc score of at least 2 were using OAC (warfarin 92.3%). However, the international normalized ratio was not at the therapeutic level in 41.9% of them. At discharge, 84.1% of the high-risk patients (85.5% of previously diagnosed and 79.6% of newly diagnosed) and 57.0 and 37.0% of the moderate-risk and low-risk patients were on OAC, respectively. Of the high-risk patients, 5.4% were treated with aspirin. CONCLUSION: These data showed that OAC was prescribed frequently to patients with symptomatic AF and risk factors for stroke. However, in patients using warfarin, international normalized ratio was not at the therapeutic level in a large proportion of the patients with previously diagnosed AF.

Predictors of pocket hematoma in patients on antithrombotic therapy undergoing cardiac rhythm device implantation: insights from the FinPAC trial.

BACKGROUND: The FinPAC trial showed that the strategy of uninterrupted oral anticoagulation (OAC) was non-inferior to interrupted OAC for the primary outcome of bleeding and thromboembolic complications in patients undergoing cardiac rhythm management device (CRMD) implantation. METHODS: We conducted a post hoc analysis of the FinPAC data to explore the incidence and predictors of significant (> 100 cm(2)) pocket hematoma after CRMD implantation among the study population (n = 447). A total of 213 patients were on OAC, 128 were on aspirin, and 106 on no antithrombotic therapy. RESULTS: The incidence of significant pocket hematoma during hospital stay was significantly higher among patients using OAC (5.6%) and aspirin (5.5%) than in those with no antithrombotic medications (0.9%), but only one patient (0.8%) in the aspirin group needed revision of hematoma. Two patients (0.9%) in the OAC group and one (0.8%) in the aspirin group needed blood products. In multivariable regression analysis, no pre- procedural features predicted the significant hematoma in any of the groups. CONCLUSIONS: Clinically significant pocket hematoma is a rare complication after CRMD implantation in patients with ongoing therapeutic OAC. The incidence of significant pocket hematoma formation is similar in patients using OAC and those using aspirin.