Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation

BackgroundPercutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)–related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown.ObjectivesThis study sought to compare DOACs with LAAC in high-risk patients with AF.MethodsLeft Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA₂DS₂-VASc of ≥3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat.ResultsA high-risk patient cohort (CHA₂DS₂-VASc: 4.7 ± 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients.ConclusionsAmong patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944)     

Predictors of Major Bleeding Among Working-Age Adults with Atrial Fibrillation: Evaluating the Effects of Potential Drug-drug Interactions and Switching from Warfarin to Non-vitamin K Oral Anticoagulants

Purpose

This study aims to evaluate the associations between switching from warfarin to non-vitamin K oral anticoagulants (NOACs), exposure to potential drug-drug interactions (DDIs), and major bleeding events in working-age adults with atrial fibrillation (AF).

Methods

We conducted a retrospective cohort study using the claims database of commercially insured working-age adults with AF from 2010 to 2015. Switchers were defined as patients who switched from warfarin to NOAC; non-switchers were defined as those who remained on warfarin. We developed novel methods to calculate the number and proportion of days with potential DDIs with NOAC/warfarin. Multivariate logistic regressions were utilized to evaluate the associations between switching to NOACs, exposure to potential DDIs, and major bleeding events.

Results

Among a total of 4126 patients with AF, we found a significantly lower number of potential DDIs and the average proportion of days with potential DDIs in switchers than non-switchers. The number of potential DDIs (AOR 1.14, 95% CI 1.02–1.27) and the HAS-BLED score (AOR 1.64, 95% CI 1.48–1.82) were significantly and positively associated with the likelihood of a major bleeding event. The proportion of days with potential DDIs was also significantly and positively associated with risk for bleeding (AOR 1.42, 95% CI 1.03, 1.96). We did not find significant associations between switching to NOACs and major bleeding events.

Conclusions

The number and duration of potential DDIs and patients’ comorbidity burden are important factors to consider in the management of bleeding risk in working-age AF adults who take oral anticoagulants.

     

Left atrial appendage closure in end-stage renal disease and hemodialysis: Data from a German multicenter registry

Background

Left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). OAC treatment has been proven feasible in mild-to-moderate chronic kidney disease (CKD). In contrast, the optimal antithrombotic management of AF patients with end-stage renal disease (ESRD) is unknown and LAAC has not been proven in these patients in prospective randomized clinical trials.

Objectives

The objective of this study is to evaluate safety and efficacy of LAAC in patients with ESRD.

Methods

Patients undergoing LAAC were collected in a German multicenter real-world observational registry. A composite endpoint consisting of the occurrence of ischemic stroke/transient ischemic attack, systemic embolism, and/or major clinical bleeding was assessed. Patients with ESRD were compared with propensity score-matched patients without severe CKD. ESRD was defined as a glomerular filtration rate < 15 ml/min/1.73 m² or chronic hemodialysis treatment.

Results

A total of 604 patients were analyzed, including 57 with ESRD and 57 propensity-matched patients. Overall, 596 endocardial and 8 epicardial LAAC procedures were performed. Frequency of major complications was 7.0% (42/604 patients) in the overall cohort, 8.8% (5/57 patients) in patients with ESRD, and 10.5% (6/57 patients) in matched controls (p = 0.75). The estimated event-free survival of the combined endpoint after 500 days was 90.7 ± 4.5% in patients with ESRD and 90.2 ± 5.5% in matched controls (p = 0.33).

Conclusions

LAAC had comparable procedural safety and clinical efficacy in patients with ESRD and patients without severe CKD.     

Incidence,Predictors, and Prognostic Value of Acute Kidney Injury Among Patients Undergoing Left Atrial Appendage Closure

Objectives

The aims of this registry were to determine the incidence, predictors, and prognostic value of periprocedural acute kidney injury (AKI) after left atrial appendage closure (LAAC).

Comparison of bleeding risk scores in patients with atrial fibrillation: insights from the RE‐LY trial

Background

Oral anticoagulation is the mainstay of stroke prevention in atrial fibrillation (AF), but must be balanced against the associated bleeding risk. Several risk scores have been proposed for prediction of bleeding events in patients with AF.

Objectives

To compare the performance of contemporary clinical bleeding risk scores in 18 113 patients with AF randomized to dabigatran 110 mg, 150 mg or warfarin in the RE‐LY trial.

Methods

HAS‐BLED, ORBIT, ATRIA and HEMORR₂HAGES bleeding risk scores were calculated based on clinical information at baseline. All major bleeding events were centrally adjudicated.

Results

There were 1182 (6.5%) major bleeding events during a median follow‐up of 2.0 years. For all the four schemes, high‐risk subgroups had higher risk of major bleeding (all P  < 0.001). The ORBIT score showed the best discrimination with c‐indices of 0.66, 0.66 and 0.62, respectively, for major, life‐threatening and intracranial bleeding, which were significantly better than for the HAS‐BLED score (difference in c‐indices: 0.050, 0.053 and 0.048, respectively, all P  < 0.05). The ORBIT score also showed the best calibration compared with previous data. Significant treatment interactions between the bleeding scores and the risk of major bleeding with dabigatran 150 mg BD versus warfarin were found for the ORBIT (P  = 0.0019), ATRIA (P  < 0.001) and HEMORR₂HAGES (P  < 0.001) scores. HAS‐BLED score showed a nonsignificant trend for interaction (P  = 0.0607).

Conclusions

Amongst the current clinical bleeding risk scores, the ORBIT score demonstrated the best discrimination and calibration. All the scores demonstrated, to a variable extent, an interaction with bleeding risk associated with dabigatran or warfarin.

     

Predictors of stroke or systemic embolism in patients with non-valvular atrial fibrillation with CHA2DS2-VASc score of 0

Background

Anticoagulant therapy has been important for stroke prevention in patients with atrial fibrillation (AF). However, it was not recommended due to its relatively higher risk of bleeding than its lower risk of stroke in patients with a CHA₂DS₂-VASc score of 0.

Hypothesis

This study aimed to evaluate the predictors of stroke in AF patients with very low risk of stroke.

Methods

Between 1990 and 2020, 542 patients with non-valvular AF (NVAF) with a CHA₂DS₂-VASc score of 0 followed up for at least 6 months were enrolled. Patients with only being woman as a risk factor were included as a CHA₂DS₂-VASc score of 0 in this study. The primary outcome was stroke or systemic embolism.

Results

The primary outcome rate was 0.78%/year. In Cox hazard model, age of ≥50 years at diagnosis (hazard ratio [HR] 6.710, 95% confidence interval [CI] 1.811–24.860, p = .004), LVEDD of ≥46 mm (HR 4.513, 95% CI 1.038–19.626, p = .045), and non-paroxysmal AF (HR 5.575, 95% CI 1.621–19.175, p = .006) were identified as independent predictors of stroke or systemic embolism. Patients with all three independent predictors had a higher risk of stroke or systemic embolism (4.21%/year), whereas those without did not have a stroke or systemic embolism.

Conclusion

The annual stroke or systemic embolism rate in NVAF patients with CHA₂DS₂-VASc score of 0 was 0.78%/year, and age at AF diagnosis, LVEDD, and non-paroxysmal AF were independent predictors of stroke or systemic embolism in patients considered to have a very low risk of stroke.     

Association of right bundle branch block or intraventricular conduction delay with recurrence of atrial fibrillation after catheter ablation

Background

The association between bundle branch block (BBB) and recurrence of atrial fibrillation (AF) after catheter ablation is unclear. The aim of this study was to determine whether AF combined with BBB is associated with AF recurrence after catheter ablation.

Methods

A total of 477 consecutive AF patients who underwent catheter ablation were included. The AF patients were divided into three groups according to BBB: AF without BBB (n = 427), AF with right bundle branch block (AF with RBBB) (n = 16), and AF with intraventricular conduction delay (AF with IVCD) (n = 34).

Results

Of the 477 AF patients (mean age 57 years, 81% men, median CHA₂DS₂-VASc score of 1), 16 (3.4%) patients had RBBB, and 34 (7.1%) patients had IVCD. During a mean follow-up of 15.2 ± 6.7 months, 119 patients (24.9%) had recurrence of AF. Of these, 111 (26%) patients were in the AF without BBB group, with 2 (12.5%) and 6 (17.6%) patients in the RBBB and IVCD groups, respectively. The Kaplan–Meier estimate of the rate of recurrent AF was not significantly different among the three groups (p = .39). Multivariable analysis showed that persistent AF (HR 1.7, 95% CI 1.15–2.50, p = .007), chronic kidney disease (HR 2.94, 95% CI 1.20–7.17, p = .01), and left atrial diameter (HR 1.04, 95% CI 1.009–1.082, p = .01) were significantly associated with AF recurrence.

Conclusion

AF with BBB was not significantly associated with the recurrence of AF after catheter ablation in middle-aged patients with low-risk cardiovascular profile.     

Incidence and outcomes of catheter related thrombosis (CRT) in patients with acute leukemia using a platelet-adjusted low molecular weight heparin regimen

The purpose of this study is to evaluate the efficacy and safety of novel oral anticoagulant (NOAC) versus warfarin therapy in patients undergoing different operations. We performed a systematic review of MEDLINE, EMBASE, Cochrane Controlled Trials Register, and reports presented at scientific meetings. The efficacy and safety of NOACs during the perioperative period was compared to that using warfarin. Of the 2652 studies initially reviewed, we identified 9 that included 15,880 patients for the meta-analysis. Compared to warfarin, dabigatran increased the risk of major bleeding (RR 1.37, 95% CI 1.06–1.78, P?=?0.02). Apixaban (RR 0.63, 95% CI 0.40–0.99, P?=?0.04) reduced thrombotic events. NOAC therapy decreased thrombotic events in patients undergoing non-cardiac surgery (RR 0.68, 95% CI 0.50–0.92, P?=?0.02). Compared to warfarin, the administration of NOACs in the perioperative period has the same risk of thromboembolism and major bleeding. But patients undergoing non-cardiac surgery may benefit more from perioperative NOAC therapy. Apixaban may reduce thrombotic events and dabigatran increases the risk of major bleeding during the perioperative period.     

Effects of different interventions on prognosis and quality of life in patients with atrial fibrillation

Objective

To compare the effects of different intervention measures on prognosis and quality of life in patients with atrial fibrillation, in order to provide clinical basis for diagnosis and treatment.

Methods

A total of 160 patients who visited several hospitals including Shanghai Xinhua Hospital from June 2019 to June 2021 were selected. Among them, 40 cases were in the drug treatment group (DRUG group), 40 cases in the radiofrequency ablation group (Radiofrequency ablation, RFA group), and 40 cases in the catheter ablation combined with percutaneous left atrial appendage occlusion group (“"one-stop”" procedure group) and 40 cases in the percutaneous left atrial appendage closure group (Left atrial appendage closure, LAAC group). The Minnesota quality of life score (MLHFQ), ejection fraction (LVEF), and left atrial anterior and posterior diameters (LAD) were compared between the groups at 1-year follow-up, and the differences in adverse events were compared between the groups.

Results

(1) After a 1-year follow-up, overall comparison, the MLHFQ scores and the LVEF and the LAD among the four groups were statistically different (p < .01); (2) Multiple comparisons, ① the MLHFQ scores: The RFA group was the lowest, the “one-stop” operation group was lower than the DRUG group, the LAAC group was the highest (p < .01). ② LVEF: The RFA group was the highest, the “one-stop” procedure group was higher than the drug treatment group, the LAAC group was the lowest (p < .01). ③ LAD: the RFA group and the “one-stop” procedure group were smaller than the DRUG group, the DRUG group was smaller than the LAAC group (p < .01).(3) Compared with the baseline data after 1-year follow-up in each group, in the RFA group and in the “one-stop” procedure group, the MLHFQ scores was decreased, the LVEF was increased, and the LAD was decreased (p < .01); in the DRUG group: the difference was not statistically significant (p > .05); in the LAAC group, the MLHFQ scores was increased, the LVEF was decreased, and the LAD was increased (p < .01). (4) There were significant differences in the incidence of adverse events among the four groups (p < .01), the lowest in the RFA group and the highest in the LAAC group.

Conclusion

Compared with drug treatment, radiofrequency ablation and “one-stop” procedure group can improve the quality of life of patients with atrial fibrillation, improve cardiac function, and reduce the occurrence of adverse events. Percutaneous left atrial appendage occlusion affects patients' quality of life and improves cardiac function, and increases the incidence of adverse events.     

Net Clinical Benefit of Non-Vitamin K Antagonist vs Vitamin K Antagonist Anticoagulants in Elderly Patients with Atrial Fibrillation

BackgroundThe risks of thromboembolic and hemorrhagic events in patients with atrial fibrillation both increase with age; therefore, net clinical benefit analyses of anticoagulant treatments in the elderly population are crucial to guide treatment. We evaluated the 1-year clinical outcomes with non-vitamin-K antagonist and vitamin K antagonist oral anticoagulants (NOACs vs VKAs) in elderly (≥75 years) patients with atrial fibrillation in a prospective registry setting.MethodsData on 3825 elderly patients were pooled from the PREFER in AF and PREFER in AF PROLONGATION registries. The primary outcome was the incidence of the net composite endpoint, including major bleeding and ischemic cardiovascular events on NOACs (n = 1556) compared with VKAs (n = 2269).ResultsThe rates of the net composite endpoint were 6.6%/year with NOACs vs 9.1%/year with VKAs (odds ratio [OR] 0.71; 95% confidence interval [CI], 0.51-0.99; P = .042). NOAC therapy was associated with a lower rate of major bleeding compared with VKA use (OR 0.58; 95% CI, 0.38-0.90; P = .013). Ischemic events were nominally reduced too (OR 0.71; 95% CI, 0.51-1.00; P = .050). Major bleeding with NOACs was numerically lower in higher-risk patients with low body mass index (BMI; OR 0.50; 95% CI, 0.22-1.12; P = .07) or with age ≥85 years (OR 0.44; 95% CI, 0.13-1.49; P = .17).ConclusionsOur real-world data indicate that, compared with VKAs, NOAC use is associated with a better net clinical benefit in elderly patients with atrial fibrillation, primarily due to lower rates of major bleeding. Major bleeding with NOACs was numerically lower also in higher-risk patients with low BMI or age ≥85 years.     

Impact of P-wave indices in prediction of atrial fibrillation—Insight from loop recorder analysis

Background

Several P-wave indices are associated with the development of atrial fibrillation (AF). However, previous studies have been limited in their ability to reliably diagnose episodes of AF. Implantable loop recorders allow long-term, continuous, and therefore more reliable detection of AF.

Hypothesis

The aim of this study is to identify and evaluate ECG parameters for predicting AF by analyzing patients with loop recorders.

Methods

This study included 366 patients (mean age 62 ± 16 years, mean LVEF 61 ± 6%, 175 women) without AF who underwent loop recorder implantation between 2010–2020. Patients were followed up on a 3 monthly outpatient interval.

Results

During a follow-up of 627 ± 409 days, 75 patients (20%) reached the primary study end point (first detection of AF). Independent predictors of AF were as follows: age ≥68 years (hazard risk [HR], 2.66; 95% confidence interval [CI], 1.668–4.235; p < .001), P-wave amplitude in II <0.1 mV (HR, 2.11; 95% CI, 1.298–3.441; p = .003), P-wave terminal force in V₁ ≤ −4000 µV × ms (HR, 5.3; 95% CI, 3.249–8.636; p < .001, and advanced interatrial block (HR, 5.01; 95% CI, 2.638–9.528; p < .001). Our risk stratification model based on these independent predictors separated patients into 4 groups with high (70%), intermediate high (41%), intermediate low (18%), and low (4%) rates of AF.

Conclusions

Our study indicated that P-wave indices are suitable for predicting AF episodes. Furthermore, it is possible to stratify patients into risk groups for AF using simple ECG parameters, which is particularly important for patients with cryptogenic stroke.

     

Direct current cardioversion practices following percutaneous left atrial appendage closure

Introduction

Among patients with non-valvular atrial fibrillation (AF) and percutaneous left atrial appendage closure (LAAC) undergoing direct current cardioversion (DCCV), the need for and use of LAA imaging and oral anticoagulation (OAC) is unclear.

Objective

The purpose of this study is to evaluate the real-world use of transesophageal echocardiography (TEE) or cardiac computed tomography angiography (CCTA) before DCCV and use of OAC pre- and post-DCCV in patients with AF status post percutaneous LAAC.

Methods

This retrospective single center study included all patients who underwent DCCV after percutaneous LAAC from 2016 to 2022. Key measures were completion of TEE or CCTA pre-DCCV, OAC use pre- and post-DCCV, incidence of left atrial thrombus (LAT) or device-related thrombus (DRT), incidence of peri-device leak (PDL), and DCCV-related complications (stroke, systemic embolism, device embolization, major bleeding, or death) within 30 days.

Results

A total of 76 patients with AF and LAAC underwent 122 cases of DCCV. LAAC consisted of 47 (62%), 28 (37%), and 1 (1%) case of Watchman 2.5, Watchman FLX, and Lariat, respectively. Among the 122 DCCV cases, 31 (25%) cases were identified as “non-guideline based” due to: (1) no OAC for 3 weeks and no LAA imaging within 48 h before DCCV in 12 (10%) cases, (2) no OAC for 4 weeks following DCCV in 16 (13%) cases, or (3) both in 3 (2%) cases. Among the 70 (57%) cases that underwent TEE or CCTA before DCCV, 16 (23%) cases had a PDL with a mean size of 3.0 ± 1.1 mm, and 4 (6%) cases had a LAT/DRT on TEE resulting in cancellation. There were no DCCV-related complications within 30 days.

Discussion

There is a widely varied practice pattern of TEE, CCTA, and OAC use with DCCV after LAAC, with a 6% rate of LAT/DRT. LAA imaging before DCCV appears prudent in all cases, especially within 1 year of LAAC, to assess for device position, PDL, and LAT/DRT.     

Sex-related differences in outcome after left atrial appendage occlusion: Insights from Europe and the EWOLUTION registry

Background

Women with atrial fibrillation (AF) generally experience worse symptoms, poorer quality of life, and have a higher risk of stroke and death. There is limited availability of sex-related differences regarding left atrial appendage occlusion (LAAO).

Aims

The aim of this study was to evaluate the sex-related differences in patients undergoing LAAO in EWOLUTION.

Methods

A total of 1025 patients scheduled for elective LAAO therapy employing the WATCHMAN Gen 2.5 prospectively consented for participation; 1005 patients received a successful implant and were followed for 2 years. As we detected sex-related differences in baseline data we performed a propensity score matching. The primary endpoint is a combined endpoint of survival free from mortality, major bleeding, ischemic stroke, transitory ischemic attack (TIA) and systemic embolization (SE) up to 2-year clinical follow-up. Secondary Endpoints were periprocedural data and overall 2-year survival.

Results

Women were older but had less often vascular disease and hemorrhagic stroke. There was no sex-related significant difference after LAAO at 2 years in the combined endpoint of survival free from mortality, major bleeding, ischemic stroke, TIA, and SE (female vs. male: 79% vs.76%, p = 0.24) or in overall survival (female vs. male: 85% vs. 82%, p = 0.16). Procedural data showed a higher sealing rate after the implantation in women (complete sealing female 94% vs. male 90%, p = 0.033), significantly more pericardial effusions (female 1.2% vs. male 0.2%, p = 0.031) and a similar periprocedural risk profile.

Conclusions

Females undergoing LAAO differ in various baseline variables, but after adjustment, we observed similar safety and efficacy of LAAO with no significant difference in long-term outcomes between women and men.     

Higher FT4 level within the normal range predicts the outcome of cryoballoon ablation in paroxysmal atrial fibrillation patients without structural heart disease

Background

Accumulated evidence has indicated that a high-normal FT4 level is an independent risk factor for the clinical progression of AF. However, the association between elevated FT4 concentration within the normal range and AF recurrence after cryoballoon ablation in China is unknown.

Methods

This retrospective and observational study included 453 AF patients who underwent cryoballoon ablation from January 2016 to August 2018. Patients were classified into quartiles based on preprocedural serum FT4 concentration. The clinical characteristics of the patients and the long-term rate of AF recurrence after ablation were assessed.

Results

After a mean follow-up period of 17.4 ± 9.0 months, 91 (20.1%) patients suffered from AF recurrence. The AF recurrence rate by FT4 quartile was 17.7%, 19.0%, 21.4%, and 22.3% for participants with FT4 in quartile 1, 2, 3, and 4, respectively (p < .001). On multivariate Cox regression, FT4 concentration (HR: 1.187, 95% CI: 1.093–1.290, p < .001) and left atrial diameter (HR: 1.052, 95% CI: 1.014–1.092, p = .007) were significant predictors of AF recurrence. When stratifying for AF type, the rate of postoperative recurrence was independently increased as FT4 concentration increased in paroxysmal AF, but not in persistent AF (p < .001 in paroxysmal AF and p = .977 in persistent AF).

Conclusion

Higher FT4 level within the normal range predicted the outcome of cryoballoon ablation in Chinese paroxysmal AF patients without structural heart disease.

     

Safety and efficacy of venous thromboembolism prophylaxis in patients with cirrhosis: A systematic review and meta-analysis

Background & Aims

Patients with cirrhosis are considered in a haemostatic balance, though weaker than in normal subjects. In these patients, however, the use of pharmacological prophylaxis for venous thromboembolism (VTE) remains controversial. Therefore, in this study, we aimed to assess the safety and efficacy of VTE prophylaxis in patients with cirrhosis.

Methods

We conducted a systematic review of studies reporting the occurrence of bleeding and VTE events in patients with cirrhosis, and controls, undergoing VTE prophylaxis. Meta-regression analysis was conducted to further explore the determinants of heterogeneity in the study of the occurrence of either bleeding or VTE events.

Results

In a total of 10 studies, including 5712 patients, of which 2330 undergoing VTE prophylaxis, bleeding (n = 5513) and VTE events occurred in 8.2% and 2.8% patients respectively. A total of 2963 and 3162 patients were included from low-risk of bias studies in bleeding and VTE analysis respectively: while administration of VTE prophylaxis did not seem to reduce VTE (OR = 1.07, CI 0.39–2.96, p = .89), importantly prophylaxis was not associated with increased bleeding risk (OR = 0.56, CI 0.20–1.59, p = .27). Meta-regression analysis showed that no parameter significantly influenced the heterogeneity of data regarding bleeding or VTE events.

Conclusions

In patients with cirrhosis, current evidence is insufficient to advise for or against the use of VTE prophylaxis, mainly due to lack of quality and homogeneity of available data. However, its use does not appear to be associated with a significant bleeding risk. Adequately designed studies are required to provide a measure of its overall utility.     

TIMI‐AF score and cardiovascular events in vitamin K antagonists‐naïve outpatients with atrial fibrillation

Background

The TIMI‐AF score predicts poor outcomes in patients with atrial fibrillation (AF) and guides selection of anticoagulant therapy by identifying clinical benefit of direct oral anticoagulants (DOACs) or vitamin K antagonists (VKA).

Hypothesis

Our objective was to determine the ability to predict cardiovascular events according to the TIMI‐AF score in a real‐world population.

Methods

Retrospective observational study of VKA‐naïve patients with AF was seen at a cardiology outpatient clinic in Spain between November 2012 and August 2014. We recorded adverse events (myocardial infarction, systemic embolism or stroke, major bleeding, and death).

Results

The study population comprised of 426 patients (50.7% men, mean age, 69 ± 14 years). The TIMI‐AF score identified 372 patients (87.3%) with a low risk, 50 patients (11.7%) with an intermediate risk, and 4 patients (0.9%) with a high risk. After a mean follow‐up of 423.4 ± 200.1 days, 37 patients (9%) experienced an adverse event. Patients with a TIMI‐AF score ≥ 7 had a poorer cardiovascular prognosis (HR, 6.1; 95%CI, 3.2‐11.7; P < 0.001). The area under the ROC curve of TIMI‐AF was 0.755 (95%CI, 0.669‐0.840; P < 0.001), which was greater than that of CHA₂DS₂VASc (0.641; 95%CI, 0.559‐0.724; P = 0.004), HAS‐BLED (0.666; 95%CI, 0.578‐0.755; P < 0.001), and SAMeTT₂R₂ (0.529; 95%CI, 0.422‐0.636; P = 0.565). Similar results were obtained in relation to the net clinical outcome (life‐threatening bleeding, disabling stroke, or all‐cause mortality).

Conclusions

The TIMI‐AF risk score can identify patients who are at greater risk of cardiovascular events and a poor net clinical outcome with a better diagnostic yield than CHA₂DS₂VASc, HAS‐BLED, and SAMeTT₂R₂.     

Non-vitamin K antagonist oral anticoagulation versus left atrial appendage occlusion for primary and secondary stroke prevention after cardioembolic stroke

IntroductionThis study aimed to evaluate the performance of non-vitamin K antagonist oral anticoagulation (NOAC) in patients with previous stroke and non-valvular atrial fibrillation (AF) compared with left atrial appendage occlusion (LAAO) in primary and secondary stroke prevention settings.MethodsThis was a prospective, single-center, non-randomized cohort study of 302 consecutive patients with non-valvular AF and at high risk for stroke. Two treatment strategies were compared: LAAO (n=91) and long-term treatment with NOAC (n=149). The primary outcome was the composite endpoint of death, stroke and major bleeding. Propensity score and cause-of-death analyses were performed to compare outcomes.ResultsIn a mean follow-up of 13 months, there were 30 deaths (LAAO 8.8% vs. NOAC 14.8%), five strokes (LAAO 1.1% vs. NOAC 2.7%) and six major bleeds (LAAO 1.1% vs. NOAC 3.4%). There was a non-significant trend for a lower incidence of the primary endpoint in the LAAO group (11.0% vs. 20.9%; HR 0.42, 95% CI 0.17-1.05, p=0.064). Considering only secondary prevention LAAO patients (34.1% of the LAAO group), there was also a non-significant lower incidence of the primary endpoint (LAAO 6.5% vs. 20.9%; HR 0.30, 95% CI 0.07-1.39, p=0.12). While about a fifth of LAAO patients stopped antiplatelet treatment six months after device implantation due to recurrent minor bleeding, no adverse cardiovascular event or major bleeding occurred in this subset of patients.ConclusionIn this registry-based study, LAAO was a reasonable alternative to NOAC for the prevention of a composite endpoint of all-cause mortality, stroke and major bleeding in patients at high risk for stroke.     

Impacto pronóstico de la enfermedad renal crónica sobre el cierre percutáneo de la orejuela izquierda en la fibrilación auricular: una experiencia unicéntrica

BackgroundPercutaneous left atrial appendage closure (LAAC) has been proposed as an alternative to anticoagulation therapy in patients with nonvalvular atrial fibrillation to decrease the thromboembolic risk, while avoiding the risks of chronic anticoagulation. This option may be attractive in patients with nonvalvular atrial fibrillation and chronic kidney disease (CKD), since they exhibit both high-thromboembolic and bleeding risks.ObjectiveTo evaluate the prognostic impact of the presence of CKD in patients with atrial fibrillation undergoing LAAC peri-procedure and during the follow-up as compared with patients with preserved renal function.MethodsRetrospective, observational study that included 124 consecutive patients with atrial fibrillation undergoing LAAC in a university hospital, and the results were evaluated according to the baseline renal function of the patients.ResultsThe median age was 75.5 years (IQR 67.6–80) and 62.1% were men, the median of CHA₂DS₂-Vasc and HASBLED scores was 4 (IQR 3–4) for both scores. Up to 57.3% of the total sample had CKD. Baseline characteristics were similar between groups, but CKD patients were older and had a higher HASBLED score. During the procedure, no thromboembolic, bleeding events, or deaths were observed. Combining the time of hospitalization and follow-up, no significant differences were observed between groups in the annual rate of thromboembolic events (0.97/100 patient-years [100PY] vs. 4.06/100PY, p = .09), but there was a higher rate of bleeding events (5.67/100PY vs. 13.3/100PY, p = .033) and mortality among CKD patients (6.50/100PY vs. 17.2/100PY, p = .009), with an odds ratio of 2.711 (95% CI 1.96–6.95). In the multivariate analysis, a preserved eGFR was independently associated with a lower mortality risk.ConclusionsLAAC is a valid alternative to oral anticoagulation in patients with CKD and atrial fibrillation, with a low-rate of peri- and post-procedure complications, although CKD patients exhibited a higher risk of bleeding and mortality during the follow-up. However, these higher rates may not be necessarily related to the procedure.     

Abstracts of the 27th Annual Conference of APASL,March 14–18, 2018, New Delhi,India

Background and aims

Spontaneous bacteremia is a poorly characterized infection in patients with cirrhosis. We compared the incidence of mortality and acute kidney injury in patients with spontaneous bacterial peritonitis and spontaneous bacteremia, and identified risk factors for mortality and acute kidney injury in patients with spontaneous bacteremia.

Methods

We performed a retrospective cohort study of patients with cirrhosis and spontaneous bacteremia or spontaneous bacterial peritonitis from 2008 to 2016 at Hospital Italiano, Buenos Aires. We compared the cumulative incidence of acute kidney injury and death between the two infections, and identified risk factors for these outcomes in patients with spontaneous bacteremia.

Results

Seventy-one patients with spontaneous bacteremia and 55 patients with spontaneous bacterial peritonitis were included. Most infections were nosocomial. Overall, 26% of bacteria were resistant and 11% multi-resistant. We found no significant association between acute kidney injury [subhazard ratio (sHR) 1.05 (95% confidence interval, CI 0.67–1.63, p = 0.83)] or death [sHR 1.15 (95% CI 0.60–2.20, p = 0.68)] and type of spontaneous infection in multivariate analyses adjusting for basal Model for End-Stage Liver Disease (MELD) score. In patients with spontaneous bacteremia, baseline MELD score was independently associated with acute kidney injury [sHR 1.07 (95% CI 1.03–1.11, p = 0.001)] and death [sHR 1.07 (95% CI 1.02–1.15, p = 0.03)].

Conclusions

Short-term acute kidney injury and mortality rates were similar in patients with spontaneous bacteremia and spontaneous bacterial peritonitis. Risk assessment of patients with spontaneous bacteremia can be performed with baseline MELD score.

     

Performance of two tools for pulmonary vein occlusion assessment with a novel navigation system in cryoballoon ablation procedure

Introduction

Optimal occlusion of pulmonary vein (PV) is essential for atrial fibrillation (AF) cryoballoon ablation (CBA). The aim of the study was to investigate the performance of two different tools for the assessment of PV occlusion with a novel navigation system in CBA procedure.

Methods

In consecutive patients with paroxysmal AF who underwent CBA procedure with the guidance of the novel 3-dimentional mapping system, the baseline tool, injection tool and pulmonary venography were all employed to assess the degree of PV occlusion, and the corresponding cryoablation parameters were recorded.

Results

In 23 patients (mean age 60.0 ± 13.9 years, 56.5% male), a total of 149 attempts of occlusion and 122 cryoablations in 92 PVs were performed. Using pulmonary venography as the gold standard, the overall sensitivity, specificity of the baseline tool was 96.7% (95% confidence interval [CI] 90.0%–99.1%), and 40.5% (95% CI 26.0%–56.7%), respectively, while the corresponding value of the injection tool was 69.6% (95% CI 59.7%–78.1%), and 100.0% (95% CI 90.6%–100.0%), respectively. Cryoablation with optimal occlusion showed lower nadir temperature (baseline tool: −44.3 ± 8.4°C vs. −35.1 ± 6.5°C, p < .001; injection tool: −46.7 ± 6.4°C vs. −38.3 ± 9.2°C, p < .001) and longer total thaw time (baseline tool: 53.3 ± 17.0 s vs. 38.2 ± 14.9 s, p = .003; injection tool: 58.5 ± 15.5 s vs. 41.7 ± 15.2 s, p < .001) compared with those without.

Conclusions

Both tools were able to accurately assess the degree of PV occlusion and predict the acute cryoablation effect, with the baseline tool being more sensitive and the injection tool more specific.