Uninterrupted Vitamin K Antagonists Research Articles

Transcatheter aortic valve implantation in patients with uninterrupted vitamin K antagonists.

Bridging of vitamin K antagonist (VKA) with heparin is usually not promoted during interventional or surgical procedures related to increased risk of bleeding and thrombotic events but this strategy has not been evaluated during transcatheter aortic valve implantation (TAVI). The aim of this study was to evaluate the rate of major bleeding and vascular complications after TAVI performed in patients with uninterrupted VKA. From January 2016 to October 2017, consecutive patients who underwent TAVI with uninterrupted VKA (International Normalized Ratio [INR]between 1.5 and 3.5) were prospectively included in a monocentric registry. TAVI was performed according to current guidelines and a 50 U/kgbolus of heparin was injected at the beginning of the procedure for all patients. Vascular and bleeding complications were assessed using the Valve Academic Research Consortium 3 (VARC3) and the Bleeding Academic Research Consortium (BARC) definitions at a 30-day follow-up. A total of 88 patients were included with a median age of 84 years (81.8-87.0), 42% being female. The median society of thoracic surgeons score was 5.1 (4.1-7.5), the median CHADS2-VAScwas 5.5 (5-6)and 60.2% had a chronic kidney failure. Median INR at the time of implantation was 2.1 (1.8-2.6). The main VKA indication was atrial fibrillation. Transfemoral access was used in 88.6% of the patients. Major bleeding (BARC ≥ 3b) occurred in five patients (5.7%) and major vascular complications occurred in seven patients (8.0%). At 1month follow-up, major bleeding (BARC ≥ 3) or vascular complications occurred in 10 patients (11.4%). In patients with major bleeding peripheral arterial disease (RR = 10.95; 95% confidence interval (CI) 1.63-73.75; p = 0.014) and carotid access (RR = 8.56; 95% CI 1.19-1.51; p = 0.033) were more common. INR > 2.5 was significantly associated with vascular complications (RR = 7.14; 95% CI 1.29-39.63; p = 0.025). At 30 days, mortality and stroke rates were 2.3% and 4.5%, respectively. TAVI with uninterrupted VKA treatment seems feasible and safe with a low risk of major bleeding and vascular complications in this first single-center experience. Particular caution is advocated in high body mass index patients and to keep INR < 2.5.

Outcomes of leadless pacemaker implantation in patients with mechanical heart valves.

Device infections constitute a major complication of transvenous pacemakers. Mechanical heart valves (MHV) increase the risk of infective endocarditis (IE) and pacemaker infection, requiring lifelong vitamin K-antagonists (VKA), which may affect patient management. Leadless pacemakers (LP) are associated with low infection rates, posing an attractive option in MHV patients requiring permanent pacing. This study describes outcomes following LP implantation in patients with MHV. This is a multicenter, observational, retrospective study including consecutive patients implanted with an LP at 5 centers between June 2015 and January 2020. Procedural outcomes, antithrombotic management, complications, performance during follow-up and episodes of bacteremia and IE were compared between patients with and without an MHV (MHV and non-MHV groups). Four hundred fifty-nine patients were included (74 in the MHV group, 16.1%, and 385 in the non-MHV group, 83.9%). Procedural outcomes and acute electrical performance were comparable between groups. Vascular complications and cardiac perforation occurred in 2.7 versus 2.3% (p = 1) and 0% versus 0.8% (p = 1) in the MHV group and non-MHV group. One case of IE occurred in the MHV group and 2 in the non-MHV group. In MHV patients, uninterrupted VKA was used in 83.8%, whereas 16.2% were heparin-bridged. Vascular complication or tamponade occurred in 1 (8.3%) MHV heparin-bridged patient versus 1 (1.6%) MHV uninterrupted VKA patient (p = .3). LP implantation outcomes in MHV patients are comparable to the general LP population. Device-related infections are rare following LP implantation, including in patients with MHV. In the MHV group, periprocedural anticoagulation management was not associated with significantly different rates of tamponade or vascular complication.

Bleeding Outcomes After Dental Extraction in Patients Under Direct-Acting Oral Anticoagulants vs. Vitamin K Antagonists: A Systematic Review and Meta-Analysis.

Background: The current systematic review aimed to compare bleeding outcomes in dental extraction patients receiving uninterrupted Direct-acting oral anticoagulant (DOAC) or Vitamin K antagonists (VKAs) for various systemic diseases. Methods: PubMed, Embase, ScienceDirect, CENTRAL, and Google Scholar databases were searched for randomized controlled trials, controlled clinical trials, prospective and retrospective cohort studies, and case control studies, conducted on adult patients undergoing dental extraction under uninterrupted DOAC or VKAs therapy and reporting bleeding outcomes. The search was conducted up to March 31, 2021. We pooled data to calculate risk ratios (RR) with 95% confidence intervals (CI) in a random-effects model. Results: Eight studies comparing 539 patients on DOAC therapy and 574 patients on VKAs were included. Meta-analysis indicated a statistically significant lower bleeding risk in patients under DOAC therapy (RR 0.68 95% CI 0.49, 0.95 I2 = 0%). However, on sensitivity analysis, the results were statistically non-significant after exclusion of any of the included studies. On pooled analysis of limited number of studies, we found no statistically significant difference in the risk of bleeding between apixaban (RR 0.85 95% CI 0.45, 1.60 I2 = 0%), rivaroxaban (RR 0.95 95% CI 0.36, 2.48 I2 = 45%), dabigatran (RR 0.49 95% CI 0.19, 1.28 I2 = 5%), edoxaban (RR 0.41 95% CI 0.13, 1.27 I2 = 0%) and VKAs. Conclusion: The results of the first review comparing bleeding outcomes after dental extraction in patients on uninterrupted DOAC or VKA therapy indicates that patients on DOAC may have a reduced risk of hemorrhage. Current evidence is of very low-quality and should be interpreted with caution. Data on individual DOAC is scarce and at this point, the difference in the risk of bleeding between these drugs cannot be elucidated. Further studies with a large sample size shall supplement our conclusion.

Comparison of major bleeding events of uninterrupted non-vitamin K antagonist oral anticoagulants versus uninterrupted vitamin K antagonist during catheter ablation of atrial fibrillation: a meta-analysis of randomised controlled trials

Background Previous meta-analyses comparing major bleeding of uninterrupted non-vitamin K antagonist oral anticoagulants (NOACs) versus uninterrupted vitamin K antagonist (VKA) during catheter ablation (CA) of atrial fibrillation (AF) had no consensus. This meta-analysis was performed to comprehensively evaluate the risk of major bleeding events of these two anticoagulant strategies. Methods We searched online databases for randomised controlled trials that compared major bleeding events of uninterrupted NOACs and VKA during CA of AF. A fixed-effect model was used if P-value was > 0.10 and I 2 was < 50%, otherwise a random- effect model was used. Results Six studies including 2392 patients were included in the analysis. The incidence of major bleeding was lower in the NOACs group than in the VKA group (OR = 0.56, 95% CI = 0.34 − 0.93, I 2 = 38%, p = 0.15). Subgroup analyses showed that the incidence of severe puncture site complications was lower in the NOACs group than in the VKA group (OR = 0.53, 95% CI = 0.30 − 0.96, I 2 = 16%, p = 0.32). But the incidence of cardiac tamponade (OR = 0.53, 95% CI = 0.23 − 1.26, I 2 = 0%, p = 0.46), intracranial (OR = 0.25, 95% CI = 0.03 − 2.23, I 2 = 0%, p = 0.82) and gastrointestinal bleeding (OR = 0.98, 95% CI = 0.18 − 5.39, I 2 = 0%, p = 0.43) had no statistically differences between the two groups. Conclusion This meta-analysis suggests that compared to uninterrupted VKA, uninterrupted NOACs are superior in major bleeding during CA of AF, but this superiority existed only in the aspect of severe puncture site complications.

Uninterrupted direct oral anticoagulants and vitamin K antagonists during ablation for atrial fibrillation: an updated meta-analysis

Abstract Background Uninterrupted anticoagulation during catheter ablation of atrial fibrillation (CAAF) became standard of care after positive results of trials investigating vitamin K antagonists (VKA). Previous studies and meta-analyses of uninterrupted direct oral anticoagulants (DOAC) vs. VKA have given controversial results. We thus aimed to elucidate the risks and benefits of uninterrupted DOAC vs. VKA during CAAF in an updated meta-analysis of randomized controlled trials (RCTs). Methods Online databases were searched for RCTs comparing uninterrupted DOAC to VKA in patients undergoing CAAF until September 2019. Data from retrieved studies were analysed in a comprehensive meta-analysis. Primary safety outcome was major bleeding; primary efficacy outcome was stroke or transient ischemic attack (TIA). Secondary outcomes included a composite of major bleeding and stroke or TIA, minor bleeding, acute cerebral lesions on magnetic resonance imaging (ACL) and mortality. Results Six eligible RCTs comprising 2,369 patients were included. Pooled meta-analysis showed no significant differences in DOAC vs. VKA concerning the rates of major bleeding (2.2% vs. 3.8%; odds ratio (OR) 0.69, 95% confidence interval (CI) 0.30–1.56; p=0.37) and stroke or TIA (0.2% vs. 0.2%; OR 0.97, CI 0.20–4.72; p=0.97). There were no significant differences found in secondary outcomes (OR 0.73, p=0.49 for composite of major bleeding and stroke or TIA; OR 1.08, p=0.52 for minor bleeding; OR 1.12, p=0.59 for ACL; and OR=0.60, p=0.64 for all-cause mortality). Conclusion Our meta-analysis suggests that uninterrupted periprocedural anticoagulation with DOAC or VKA is characterized by a similar risk/benefit ratio in patients undergoing CAAF with comparable rates of major bleeding and stroke. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Medical faculty of the Heinrich-Heine-University Düsseldorf, Germany

Activated clotting time monitoring during atrial fibrillation catheter ablation: Does the anticoagulant matter?

Atrial fibrillation (AF) catheter ablation is performed in patients receiving direct oral anticoagulants (DOACs). Guidelines recommend to perform the procedure with uninterrupted anticoagulation and intra-procedural unfractionated heparin (UFH) administration to achieve activated clotting time (ACT) at 300 seconds, as recommended for vitamin K antagonist (VKA). To determine whether ACT monitoring might be transposed from VKA to DOAC-treated patients. From 124 patients receiving either uninterrupted DOAC (dabigatran, rivaroxaban, apixaban) or VKA or being untreated, blood sampling was performed for anticoagulation testing. DOAC concentrations, and INR for VKA were measured. ACT was determined at baseline, and after spiking with UFH doses equivalent to 1000, 2500, 5000 and 10000 IU in vivo. At baseline, the extent to which oral anticoagulants prolonged ACT differed: despite similar concentrations, ACT was longer with dabigatran and shorter with apixaban (both P < 0.001). The relationship between ACT and the intensity of anticoagulation also differed: ACT strongly correlated with INR ( r = 0.73, P < 0.001) and dabigatran concentration ( r = 0.87, P < 0.0001), but poorly correlated with apixaban or rivaroxaban concentrations. Moreover, the effects of UFH on ACT prolongation depended on the anticoagulant onboard: dose-response curves in samples from VKA and dabigatran-treated patients were parallel whereas ACT prolongation in response to UFH was significantly lower in the presence of FXa-inhibitors, especially apixaban. UFH administration to achieve ACT at 300 seconds may be transposed from VKA to uninterrupted dabigatran-treated patients but not to patients receiving FXa inhibitors, especially apixaban: targeting 300 seconds might expose to UFH overdosing, and bleeding complications. These findings question the indiscriminate use of ACT in AF ablation.

Uninterrupted Dabigatran Administration Provides Greater Inhibition against Intracardiac Activation of Hemostasis as Compared to Vitamin K Antagonists during Cryoballoon Catheter Ablation of Atrial Fibrillation.

Background. Cerebral thromboembolism is a rare but feared complication of transcatheter ablation in patients with atrial fibrillation (AF). Here, we aimed to test which pre-procedural anticoagulation strategy results in less intracardiac activation of hemostasis during ablation. Patients and methods. In this observational study, 54 paroxysmal/persistent AF patients undergoing cryoballoon ablation were grouped according to their periprocedural anticoagulation strategy: no anticoagulation (oral anticoagulation (OAC) free; n = 24), uninterrupted vitamin K antagonists (VKA) (n = 11), uninterrupted dabigatran (n = 17). Blood was drawn from the left atrium before and immediately after the ablation procedure. Cryoablations were performed according to standard protocols, during which heparin was administered. Heparin-insensitive markers of hemostasis and endothelial damage were tested from intracardiac samples: D-dimer, quantitative fibrin monomer (FM), plasmin-antiplasmin complex (PAP), von Willebrand factor (VWF) antigen, chromogenic factor VIII (FVIII) activity. Results. D-dimer increased significantly in all groups post-ablation, with lowest levels in the dabigatran group (median [interquartile range]: 0.27 [0.36] vs. 1.09 [1.30] and 0.74 [0.26] mg/L in OAC free and uninterrupted VKA groups, respectively, p < 0.001). PAP levels were parallel to this observation. Post-ablation FM levels were elevated in OAC free (26.34 [30.04] mg/L) and VKA groups (10.12 [16.01] mg/L), but remained below cut-off in all patients on dabigatran (3.98 [2.0] mg/L; p < 0.001). VWF antigen and FVIII activity increased similarly post-ablation in all groups, suggesting comparable procedure-related endothelial damage. Conclusion. Dabigatran provides greater inhibition against intracardiac activation of hemostasis as compared to VKAs during cryoballoon catheter ablation.

Minimally Interrupted Non-Vitamin K Antagonist Oral Anticoagulants vs. Bridging Therapy and Uninterrupted Vitamin K Antagonists During Atrial Fibrillation Ablation: A Retrospective Single-Center Study.

Objectives: Although the latest international guidelines recommend the use of uninterrupted non-vitamin K antagonist oral anticoagulants (NOAC) during atrial fibrillation (AF) ablation, it does not reflect current clinical practice, as most centers still use a minimally interrupted NOAC strategy. The purpose of this study was to evaluate the safety and effectiveness of minimally interrupted NOAC compared with bridging therapy and uninterrupted vitamin K antagonist (VKA) for nonvalvular AF ablation.Patients and Methods: A total of 4520 patients who underwent AF ablation between January 2010 and December 2018 were included in the analysis. According to their periprocedural anticoagulation strategies, patients were divided into three groups: Bridging heparin group (n = 1848); Uninterrupted VKA group (n = 796) and Minimally interrupted NOAC group (Total n = 1876; dabigatran: n = 865; rivaroxaban, n = 1011). A combined complication endpoint (CCE) as composed of any bleeding complications and thromboembolic events was analyzed.Results: Rates of thromboembolisms were similar among the three groups (0.22% for Bridging heparin group, 0.25% for Uninterrupted VKA group, and 0.11% for Minimally interrupted NOAC group, p = 0.626). There was a significant difference among the three groups for the incidence of overall bleeding events (8.50% for Bridging heparin group, 4.52% for Uninterrupted VKA group, and 2.67% for Minimally interrupted NOAC group, p < 0.001). A significant difference of CCE rates was shown in the Minimally interrupted NOAC group as compared with the Uninterrupted VKA group (2.77 vs. 4.77%, p = 0.008) and the Bridging heparin group (2.77 vs. 8.71%, p < 0.001). There was no significant difference in CCE rates among the different NOACs (dabigatran 2.89% vs. rivaroxaban 2.67%, p = 0.773).Conclusions: In patients undergoing AF ablation, minimally interrupted NOACs during the periprocedural period appears safer and equally effective when compared to the bridging heparin and uninterrupted VKA therapy.

P1187Pocket-Hematoma after cardiac implantable electronic devices surgery: a single centre study

Abstract Intro Pocket hematoma is a common complication after pacemaker (PMK) or implantable cardioverter defibrillator (ICD) surgery. In this clinical setting anticoagulant and antiplatelet therapy are associated with an increased risk of hemorrhagic complications, but data are sparse. Purpose We examined the impact of antiplatelet therapy and anticoagulation with vitamin K antagonists (VKA) or heparin on the risk of pocket hematoma. Materials and method: between august 2017 and june 2019, a total of 639 devices were implanted or replaced at our centre. Predictors of hematoma occurrence were determined by multivariate regression analysis. We used a specific definition of pocket hematoma: a) any palpable swelling in the pocket area requiring an unscheduled visit or prolonged hospitalization &amp;gt; 24 h or re-hospitalization for hematoma, b) interruption of antithrombotics, c) reoperation, d) hemoglobin drop &amp;gt; 2 g/dl or blood transfusion. The above criteria were assessed during hospitalization and up to 10 days after discharge. Results: the incidence of pocket hematoma was 7.5%. Among 639 patients (pts) including in the study 33.5% (214 pts) didn’ t take any antithrombotic therapy, 40.2 % (257 pts) were on single antiplatelet therapy (SAPT), 8.8 % (56 pts) were on dual antiplatelet therapy, 11.1 % (71 pts) were on uninterrupted VKA (mean INR 2). Heparin bridging was administered in 6.4% (41 pts). Ejection fraction (43 ±13 %) and hemoglobin value before implantation (12.3 ±2.6 g/dL) in patients who developed hematoma were significantly lower compared with whose without hematoma. Patients with hematoma had a higher prevalence of congestive heart failure, ischemic cardiomyopathy and intake antithrombotic therapy. After adjusting for confounding factors with multivariate logistic regression only the use of dual antiplatelet therapy (OR 5.9 95% CI 1.5-21 p = 0.008) and the bridging with enoxaparin (OR 5.6 95% CI 1.4-22 p = 0.013) increased the risk of pocket hematoma. Single antiplatelet therapy (OR 2.6 95% CI 0.8-8.4 p = ns) and uninterrupted VKA (OR 0.9 95% CI 0.7-11 p = ns) did not increased the risk of pocket hematoma compared to no antithrombotic therapy. Pulse generator change and new device implant/upgrading (OR 1.8 95% CI 0.6-5.2 p = ns) carried the same haemorrhagic risk. Conclusion the use of DAPT or bridging with enoxaparin are highly predictive for the occurrence of perioperative pocket hematoma in patients scheduled for pmk/icd surgery. In contrast, single antiplatelet therapy and uninterrupted VKA did not increase the risk of hematoma.

Meta-analysis of the safety and efficacy of using minimally interrupted novel oral anticoagulants in patients undergoing catheter ablation for atrial fibrillation.

The ideal periprocedural anticoagulation strategy for patients being treated with a novel oral anticoagulant (NOAC) during catheter ablation (CA) for atrial fibrillation (AF) is unclear. We evaluated the safety and efficacy of using a minimally interrupted NOAC strategy versus an uninterrupted NOAC or vitamin K antagonist (VKA) strategy during AF ablation. The Cochrane Library, PubMed, and EMBASE databases were searched for randomized controlled or prospective observational studies that compared a minimally interrupted NOAC strategy with an uninterrupted NOAC or VKA strategy from the time of database establishment up to December 2019. The primary endpoints were major bleeding, minor bleeding, and symptomatic thromboembolism. The secondary endpoint was silent cerebral infarction (SCI) as detected by post-ablation brain magnetic resonance imaging (MRI). A measurement of treatment effect for the endpoint was reported as pooled odds ratio (OR) with 95% confidence interval (CI). A total of 18 studies (6 randomized, 11 observational, and 1 randomized registry) with 6203 patients were included in the final analysis (47% of the patients received minimally interrupted NOAC). There was no significant difference between treatment groups regarding the risk for major bleeding (OR 1.04, 95% CI 0.69-1.57, P = 0.86, I2 = 27%). Different stratification methods did not yield significant difference regarding the risk for major bleeding. There was no difference between groups regarding the risk for minor bleeding (P = 1.00) or symptomatic thromboembolism (P = 0.26). Brain MRI results showed that both uninterrupted NOAC (OR 0.44, 95% CI 0.23-0.83, P = 0.01, I2 = 72%) and uninterrupted VKA (OR 0.48, 95% CI 0.24-0.97, P = 0.04, I2 = 36%) produced a significant reduction in the rate of SCI when compared with minimally interrupted NOAC. A periprocedural anticoagulation strategy of minimally interrupted NOAC is not superior to uninterrupted NOAC or VKA when used during AF ablation. There is evidence favoring the use of uninterrupted NOAC or VKA in terms of the risk for SCI.

Uninterrupted anticoagulation during catheter ablation for atrial fibrillation: no difference in major bleeding and stroke between direct oral anticoagulants and vitamin K antagonists in an updated meta-analysis of randomised controlled trials

Background Periprocedural uninterrupted anticoagulation for catheter ablation of atrial fibrillation (AF) became standard after positive results of vitamin K antagonist (VKA) trials. Previous studies of uninterrupted direct oral anticoagulants (DOACs) vs. VKA have given controversial results. We thus aimed to elucidate the risk/benefit ratio of uninterrupted DOAC vs. VKA during catheter ablation of AF in an updated meta-analysis of randomised controlled trials (RCTs). Methods Online databases were searched for RCTs comparing uninterrupted DOAC to VKA in patients undergoing catheter ablation of AF. Data from retrieved studies were analysed in a comprehensive meta-analysis. Primary safety outcome was major bleeding; primary efficacy outcome was stroke or transient ischaemic attack (TIA). Secondary outcomes included a composite of major bleeding and stroke or TIA, minor bleeding, acute cerebral lesions on magnetic resonance imaging (MRI), and mortality. Results Six eligible RCTs comprising 2,369 patients were included. There were no significant differences in DOAC vs. VKA concerning the rates of major bleeding (2.2% vs. 3.8%; odds ratio (OR) 0.69, 95% confidence interval (CI) 0.30–1.56; p = .37) and stroke or TIA (0.2% vs. 0.2%; OR 0.97, CI 0.20–4.72; p = .97). Pooled meta-analysis of secondary outcomes revealed no significant differences (OR 0.73, p = .49 for composite of major bleeding and stroke or TIA; OR 1.08, p = .52 for minor bleeding; OR 1.12, p = .59 for acute cerebral lesions on MRI; and OR 0.60, p = .64 for all-cause mortality). Conclusion Our meta-analysis suggests that uninterrupted DOAC is not superior to VKA in patients undergoing catheter ablation of AF with comparable rates of major bleeding and stroke.

Catheter ablation of atrial fibrillation with uninterrupted anticoagulation: a meta-analysis of six randomized controlled trials.

Uninterrupted anticoagulation is recommended during the ablation of atrial fibrillation. This meta-analysis compared the safety and efficacy of uninterrupted direct oral anticoagulants (DOACs) to uninterrupted vitamin K antagonists (VKAs) during atrial fibrillation ablation. The meta-analysis included eligible randomized controlled trials from 2009 to 2019. Odds ratios (ORs) and 95% confidence intervals were pooled using a random effects model and a sensitivity analysis was performed by sequentially removing one study or DOAC at a time. Six studies were included; 1288 received DOAC and 1081 VKA. Pooled ORs indicated a lower nonsignificant incidence in DOACs vs. VKA of composite outcome of major bleeding, stroke, or transient ischemic attack, and mortality (0.69; 0.28-1.71; 31 vs. 45 events), major bleeding alone (0.66; 0.30-1.47; 27 vs. 41 events), and cardiac tamponade (0.56; 0.21-1.45; eight vs. 13 events) with a slightly higher occurrence of minor bleeding (1.17; 0.89-1.56; 139 vs. 106 events) and silent cerebral thromboembolic events (1.12; 0.75-1.66; 72 vs. 58 among 442 and 376 patients performing MRI study). Sensitivity analyses confirmed overall results: pooled ORs ranged from 0.56 to 1.00 for the composite outcome and from 0.54 to 0.92 for major bleedings. Uninterrupted DOAC is a safe and effective alternative to uninterrupted VKA during atrial fibrillation ablation.

Safety of uninterrupted direct oral anticoagulants for ambulatory common atrial flutter catheter ablation: A propensity score–matched cohort study

Same-day home discharge after common atrial flutter catheter ablation (CAFCA) is a feasible, safe, and cost-effective practice, but there are currently no data for patients treated with direct oral anticoagulants (DOAs). We evaluated the safety, efficacy, and feasibility of ambulatory CAFCA in patients treated with DOAs compared with those treated with vitamin K antagonists (VKAs). Patients scheduled for isolated and elective ambulatory CAFCA in our tertiary university center between 2009 and 2019 were included. Propensity score for anticoagulant type was calculated from age, sex, body mass index, HAS-BLED and CHA2DS2-VASc scores, chronic kidney disease, associated antiplatelet treatment, procedure duration, and number of femoral venipunctures. Propensity score matching yielded 820 patients (mean age 67 ± 11 years). Catheter ablation was performed under uninterrupted VKA (n = 410; international normalized ratio 2.5 ± 0.6) or uninterrupted DOA (n = 410). The procedural success rate was 91%, and the effective same-day discharge rate was 93%. The occurrence of the primary end point, defined as any early and clinically significant bleeding (Bleeding Academic Research Consortium classification ≥ 2) at 1 week, was similar between patients treated with DOAs and those treated with VKAs (2.9% vs 3.7%; P = .70). Female sex, high HAS-BLED score, and prolonged procedure duration were independently associated with the primary end point. Uninterrupted DOA regimens are safe for patients undergoing ambulatory CAFCA in a high-volume center with a dedicated ambulatory unit and standardized procedural and postoperative management.

Thromboembolism and bleeding risk in atrial fibrillation ablation with uninterrupted anticoagulation between new oral anticoagulants and vitamin K antagonists: insights from an updated meta-analysis.

Cumulative reports comparing the efficacy and safety outcomes between uninterrupted NOACs and vitamin K antagonists (VKA) in AF ablation had been freshly published. This meta-analysis aimed at offering a more comprehensive evaluation between these two anticoagulants in uninterrupted strategy. We searched in PUBMED, EMBASE, and Cochrane Library (inception to June 10, 2019) for eligible studies. Fixed-effects model was preferred in pooled analysis if I2 < 50%. Publication bias was also evaluated. A total of 23 studies involving 12,725 individuals were analyzed in this literature. There were no difference between uninterrupted NOACs and VKA groups in incidence of Stroke/TIA (RR 0.98, 95% CI 0.54-1.77, P = 0.93, I2 = 0%), silent cerebral embolism (RR 1.09, 95% CI 0.82-1.43, P = 0.56, I2 = 0%), minor bleeding complication (RR 0.97, 95% CI 0.83-1.14, P = 0.73, I2 = 0%), cardiac tamponade (RR 0.95, 95% CI 0.63-1.42, P = 0.80, I2 = 0%). Uninterrupted NOACs was associated with significantly lower major bleeding incidence (RR 0.67, 95% CI 0.49-0.92, P = 0.01, I2 = 0%), pericardial effusion (RR 0.75, 95% CI 0.56-1.00, P = 0.048, I2 = 9%). In sub-analysis, no difference was found in all sub-analyses for Stroke/TIA while significant major bleeding risk reduction in uninterrupted NOACs was identified in the subgroup of CHA2DS2-VASc score ≥ 2 and target activated clotting time (ACT) > 300 s. In conclusions, uninterrupted NOACs was more effective than uninterrupted VKA in reducing major bleeding and pericardial effusion risk without increasing thromboembolism risk, and the benefits of uninterrupted NOACs on major bleeding complication could be more pronounced if CHA2DS2-VASc score ≥ 2 or target ACT > 300 s.

Significant Benefit of Uninterrupted DOACs Versus VKA During Catheter Ablation of Atrial Fibrillation.

This study assessed the incremental benefit of uninterrupted direct oral anticoagulants (DOACs) versus uninterrupted vitamin K antagonists (VKAs) for catheter ablation (CA) of nonvalvular atrial fibrillation (NVAF) on 3 primary outcomes: major bleeding events (MBEs), minor bleeding events, and thromboembolic events (TEs). The secondary outcome was post-procedural silent cerebral infarction (SCI) as detected by brain cardiac magnetic resonance. As a class, evidence of the benefits of DOACs versus VKAs during CA of AF is scant. A systematic review of Medline, Cochrane, and Embase was done to find all randomized controlled trials in which uninterrupted DOACs were compared against uninterrupted VKAs for CA of NVAF. A fixed-effect model was used, except when I2 was≥25, in which case, a random effects model was used. The benefit of uninterrupted DOACs over VKAs was analyzed from 6 randomized control trials that enrolled a total of 2,256 patients (male: 72.7%) with NVAF, finding significant benefit in MBEs (relative risk [RR]: 0.45; 95% confidence interval [CI]: 0.20 to 0.99; p=0.05). No significant differences were found in minor bleeding events (RR: 1.12; 95%CI: 0.87 to 1.43; p=0.39), TEs (RR: 0.75; 95%CI: 0.26 to 2.14; p=0.59), or post-procedural SCI (RR: 1.09; 95%CI: 0.80 to 1.49; p=0.58). An uninterrupted DOACs strategy for CA of AF appears to be safer than uninterrupted VKAs with a decreased rate of major bleeding events. There are no significant differences among the other outcomes. DOACs should be offered as a first-line therapy to patients undergoing CA of AF, due to their lower risk of major bleeding events, ease of use, and fewer interactions.

P1843Transcatheter aortic valve implantation in patients with uninterrupted vitamin k antagonist

Abstract Background Bridging of vitamin K antagonist (VKA) with heparin is usually not promoted during interventional or surgical procedures related to increased risk of bleeding and thrombotic events but this strategy has not been evaluated during TAVI. Purpose The aim of this study was to evaluate the rate of major bleeding and vascular complications after TAVI performed in patients with uninterrupted VKA. Methods From January 2016 to October 2017, consecutive patients who underwent TAVI with uninterrupted VKA (INR between 1.5 and 3.5) were prospectively included in a monocentric registry. TAVI were performed according to current guidelines and a 50UI/kg bolus of heparin was injected at the beginning of the procedure for all patients. Vascular and bleeding complications were assessed using the Valve Academic Research Consortium 2 (VARC2) and the Bleeding Academic Research Consortium (BARC) definitions at 30 day follow-up. Results A total of 88 patients were included with a median age of 84 years [81.8–87], 42% being female, the median STS score was 5.1 [4.1–7.5], the median CHADS2-VASc was 5.5 [5–6] and 60.2% had a chronic kidney failure. Median INR at time of implantation was at 2.1 [1.8–2.6]. VKA were used for atrial fibrillation (89.8%), mechanic mitral prosthesis (5.7%) or venous thromboembolic disease (4.5%). Trans femoral access was used in 88.6% of the patients. Major bleeding (BARC ≥3b) occurred in 5 patients (5,7%) and major vascular complications occurred in 7 patients (8%). Peripheral arterial disease (RR = 10.95; 95% CI: 1.63 to 73.75; p=0.014) and carotid access (RR=8.56; 95% CI: 1.19 to 61.51; p=0.033) were significantly associated with major bleeding. INR &gt;2.5 was significantly associated with vascular complications (RR=7.14; 95% CI: 1.29 to 39.63; p=0.025). In multivariate analysis, Body mass index (OR=1.26; 95% CI: 1.02 to 1.57; p=0.032) and INR &gt;2.5 (OR=18.91; 95% CI: 1.62 to 221.26; p=0.010) were independent factor significantly associated with vascular complications or major bleeding. Mortality rate at 30 days follow-up was 2.3%, there was no myocardial infarction and stroke rate was 4.5%. Figure 1. Study flowchart Conclusion TAVI with uninterrupted VKA treatment seems to be feasible and safe with low risk of bleeding and vascular complications in this first single centre experience. Particular caution is advocated in low BMI patients and to keep INR&lt;2.5.

Clinical Performance of Apixaban vs. Vitamin K Antagonists in Patients with Atrial Fibrillation Undergoing Direct Electrical Current Cardioversion: A Prospective Propensity Score-Matched Cohort Study.

Atrial fibrillation (AF) is associated with an increased risk of thromboembolic events. This study compared the long-term efficacy and safety of apixaban with that of uninterrupted vitamin K antagonist (VKA) therapy in patients with AF scheduled for transesophageal echocardiogram (TEE)-guided direct current cardioversion (DCC) from June 2014 to September 2016. We enrolled consecutive patients with persistent nonvalvular AF scheduled to undergo DCC. Patients received apixaban 5mg or 2.5mg twice daily (bid) or VKA at therapeutic doses for at least 3weeks before and 4weeks after DCC. All patients underwent anamnestic, clinical, electrocardiographic, and echocardiographic evaluation at each follow-up visit and were followed-up for 12months. The primary efficacy endpoint was the composite of stroke/transient ischemic attack and systemic embolism. The primary safety endpoint was major bleeding. After propensity score matching, comparative treatment groups comprised 182 (75.8%) patients receiving apixaban 5mg bid and 182 receiving VKA. A low incidence of atrial thrombus (0.5%) at TEE was found in both groups. The acute cardioversion success rate was 86.1% in the apixaban group (156/181) and 83.9% in the VKA group (152/181). During the follow-up period, a similarly low incidence of thromboembolic events (1.1%) was reported in both groups; the bleeding safety profile tended to favor apixaban over VKA (1.1 vs. 1.6%; p = 0.3). Newly initiated anticoagulation with apixaban in patients with nonvalvular AF scheduled for TEE-guided DCC seems to be as effective and safe as uninterrupted VKA therapy during 12months of follow-up.

Minimally interrupted novel oral anticoagulant versus uninterrupted vitamin K antagonist during atrial fibrillation ablation

PurposeThe safety and efficacy of a minimally interrupted novel oral anticoagulant (NOAC) strategy at the time of atrial fibrillation (AF) ablation is uncertain. The purpose of this study was to compare rates of bleeding and thromboembolic events between minimally interrupted NOAC and uninterrupted vitamin K antagonist (VKA) in patients undergoing AF ablation.MethodsThis was a retrospective single-center cohort study of consecutive patients who underwent AF catheter ablation between January 2013 and April 2017. Endpoints included major bleeding, clinically relevant non-major bleeding and systemic thromboembolic event from the time of ablation through 30 days. Bleeding events were defined by the Bleeding Academic Research Consortium (BARC) and International Society on Thrombosis and Haemostasis (ISTH).ResultsA total of 637 patients were included in the analysis, 520 patients used uninterrupted VKA and 117 patients minimally interrupted NOAC (dabigatran: n = 68; apixaban: n = 30; rivaroxaban, n = 14; edoxaban, n = 5). The rate of clinically relevant non-major bleeding was lower in the NOAC group in comparison to the VKA group (BARC type 2: 2.6% versus 8.3%, P = 0.03; ISTH: 0% versus 3.8%, P = 0.03). Rates of major bleeding were similar between groups (BARC type 3 to 5: 3.4% versus 4.2%, P = NS; ISTH: 6.0% versus 8.7%, P = NS; for NOAC and VKA groups, respectively). Rates of systemic embolism were 0% with minimally interrupted NOAC, and 0.6% with uninterrupted VKA (P = NS).ConclusionsIn patients undergoing AF ablation, anticoagulation with minimally interrupted NOAC was associated with fewer clinically relevant non-major bleeding events in comparison with uninterrupted VKA without compromising thromboembolic safety.

Safety and efficacy of nonvitamin K antagonist oral anticoagulants during catheter ablation of atrial fibrillation: A systematic review and meta-analysis.

Catheter ablation for atrial fibrillation (AF) is associated with a transitory increase in the risk of both thromboembolic and bleeding events. Evidence on the use of nonvitamin K antagonist oral anticoagulants (NOACs) in patients undergoing AF ablation mostly comes from small observational studies, underpowered to detect differences in clinical outcomes between NOACs and vitamin K antagonists (VKAs) treated patients. This updated meta-analysis aimed to determine the safety and efficacy of periprocedural anticoagulation with NOACs compared with VKAs in AF patients undergoing catheter ablation. We searched MEDLINE, Cochrane library, and web sources for randomized and observational studies comparing periprocedural treatment with NOACs and VKAs in patients undergoing AF ablation. The primary safety endpoint was major bleeding events, and the primary efficacy endpoint was thromboembolic events (a composite of systemic thromboembolism, transient ischemic attack, and stroke). A total of 29 studies with 12644 patients were included in the meta-analysis. Overall, patients on NOACs had a significantly lower risk of major bleeding compared to VKAs either in observational studies (Peto OR 0.68; 95% CI: 0.48-0.95; P=0.022; I2 =20%) or in RCTs (Peto OR 0.30; 95% CI: 0.14-0.62; P=0.001; I2 =28%). Uninterrupted NOACs reduced the risk of major bleeding when compared to uninterrupted VKAs (Peto OR 0.66; 95% CI: 0.45-0.96; P=0.028; I2 =1%), similarly, interrupted NOACs lowered the risk of major bleeding compared to interrupted VKAs (Peto OR 0.29; 95% CI: 0.13-0.66; P=0.003; I2 =0%; Pinteraction =0.076). The rate of thromboembolic complications was very low and did not significantly differ between the study groups either in observational studies (Peto OR 0.91; 95% CI: 0.49-1.67; P=0.755; I2 =0%) or in RCTs (Peto OR 0.14; 95% CI: 0.01-1.30; P=0.083; I2 =0%). Use of NOACs compared to VKAs significantly reduced the risk of bleeding in patients with AF ablation. Similarly, the risk of bleeding was lower with uninterrupted NOACs than with uninterrupted VKAs, and with interrupted NOACs than with interrupted VKAs. The rate of thromboembolic complications was extremely low in both study groups without any differences.

A meta-analysis of randomized controlled trials of uninterrupted periprocedural anticoagulation strategy in patients undergoing atrial fibrillation catheter ablation

BackgroundIn patients undergoing atrial fibrillation (AF) ablation, despite uninterrupted oral anticoagulants (OACs) have been recommended, no consensus has emerged regarding to whether uninterrupted novel oral anticoagulants (NOACs) are superior to uninterrupted vitamin K antagonists (VKAs) for the periprocedural antithrombotic management. This meta-analysis aimed to compare the efficacy and safety of uninterrupted NOACs and uninterrupted VKAs in patients undergoing AF ablation. MethodsDatabases were searched for articles published up to March 20, 2018. Only randomized controlled trials (RCTs) were selected. The data were analyzed with RevMan 5.3 using a fixed-effects method. Results6 RCTs and 1903 patients were included. There was no significant difference between NOACs group and VKAs group in incidence of stroke or TIA (OR = 1.00, 95% CI = 0.23–4.40, P = 1.00), silent cerebral thromboembolic events (OR = 1.09, 95% CI = 0.67–1.75, P = 0.74) or minor bleeding (OR = 1.01, 95% CI = 0.78–1.31, P = 0.93), which were consistent in subgroup analysis of individual NOAC vs. VKAs group. NOACs treatment was associated with reduced risk of major bleeding as compared with VKAs (OR = 0.45, 95% CI = 0.26–0.81, P < 0.01). In the subgroup analyses, only the dabigatran group showed significant lower incidence of major bleeding compared to VKAs group. ConclusionsIn patients undergoing AF ablation, uninterrupted NOACs is as effective as uninterrupted VKAs treatment, uninterrupted dabigatran (150 mg twice daily) may be superior to other uninterrupted OACs strategies.