Developing and Validating a Self-Care Self-Efficacy Scale for Oral Anticoagulation Therapy in Patients With Nonvalvular Atrial Fibrillation: Protocol for a Mixed Methods Study.

BACKGROUND: Oral anticoagulation therapy (OAC) is the cornerstone treatment for preventing venous thromboembolism and stroke in patients with nonvalvular atrial fibrillation (NVAF). Despite its significance, challenges in adherence and persistence to OAC regimens have been reported, leading to severe health complications. Central to addressing these challenges is the concept of self-efficacy (SE) in medication management. Currently, there is a noticeable gap in available tools specifically designed to measure SE in OAC self-care management, while such tools are crucial for enhancing patient adherence and overall treatment outcomes. OBJECTIVE: This study aims to develop and validate a novel scale aimed to measure self-care self-efficacy (SCSE) in patients with NVAF under OAC, which is the patients' Self-Care Self-Efficacy Index in Oral Anticoagulation Therapy Management (SCSE-OAC), for English- and Italian-speaking populations. We also seek to assess patients' SE in managing their OAC treatment effectively and to explore the relationship between SE levels and sociodemographic and clinical variables. METHODS: Using a multiphase, mixed methods observational study design, we first conceptualize the SCSE-OAC through literature reviews, patient focus groups, and expert consensus. The scale's content validity will be evaluated through patient and expert reviews, while its construct validity is assessed using exploratory and confirmatory factor analyses, ensuring cross-cultural applicability. Criterion validity will be examined through correlations with clinical outcomes. Reliability will be tested via internal consistency and test-retest reliability measures. The study will involve adult outpatients with NVAF on OAC treatment for a minimum of 3 months, using both e-surveys and paper forms for data collection. RESULTS: It is anticipated that the SCSE-OAC will emerge as a reliable and valid tool for measuring SE in OAC self-care management. It will enable identifying patients at risk of poor adherence due to low SE, facilitating targeted educational interventions. The scale's validation in both English and Italian-speaking populations will underscore its applicability in diverse clinical settings, contributing significantly to personalized patient-centered care in anticoagulation management. CONCLUSIONS: The development and validation of the SCSE-OAC represent a significant advancement in the field of anticoagulation therapy. Validating the index in English- and Italian-speaking populations will enable personalized patient-centered educational interventions, ultimately improving OAC treatment outcomes. The SCSE-OAC's focus on SCSE introduces a novel approach to identifying and addressing individual patient needs, promoting adherence, and ultimately improving health outcomes. Future endeavors will seek to extend the validation of the SCSE-OAC across diverse cultural and linguistic landscapes, broadening its applicability in global clinical and research settings. This scale-up effort is crucial for establishing a universal standard for measuring SCSE in OAC management, empowering clinicians and researchers worldwide to tailor effective and culturally sensitive interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT05820854; https://tinyurl.com/2mmypey7. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51489.

Hemorrhagic complications after stroke treatment with intravenous thrombolysis despite use of direct oral anticoagulants: an observational study.

Background: For patients experiencing ischemic stroke despite receiving therapy with direct oral anticoagulants (DOAC) and without endovascular treatment options, therapeutic prospects are currently dismal. Current guidelines recommend intravenous thrombolysis (IVT) only for patients who have received DOAC in very restricted settings, as an increased risk of bleeding is suspected. However, recent retrospective observational studies suggest that IVT is safe despite DOAC pretreatment. Objectives: To provide further evidence that IVT despite previous DOAC treatment is not associated with an increased risk of bleeding. Design: Observational retrospective study. Methods: Demographic, clinical, and radiological data of patients who received IVT (+/- endovascular thrombectomy) despite DOAC pretreatment between June 2021 and January 2024 were analyzed using descriptive statistics, including DOAC plasma concentration at admission. Secondary intracranial hemorrhages and functional outcomes at 3 months were assessed. Since 2023, patients have been treated according to a modified local standard operating procedure at our hospital, allowing for IVT despite DOAC pretreatment regardless of DOAC plasma levels or the use of reversal agents. Results: Of 1821 patients treated with acute recanalization procedures during the study period, N = 35 had received IVT with (18) or without (17) additional endovascular therapy. Among these patients with a wide age range (42-97 years) and DOAC plasma concentrations up to 369 ng/ml, only one developed symptomatic intracranial hemorrhage. A favorable outcome (modified Rankin scale score 0-2) after 3 months was observed in 57% (20) of the patients. Conclusion: IVT despite direct oral anticoagulation seems to be safe, even at advanced age and high DOAC plasma levels.

Bleeding problems after stroke treatment with clot-busting drugs, even when taking blood thinners After local treatment rules were changed to allow clot-busting treatment for stroke even if patients had recently used blood thinners, the number of patients receiving this treatment more than tripled. Despite not checking blood test results before treatment, serious brain bleeding was not common. The levels of blood thinners in the patients' blood did not affect the chances of having any kind of brain bleeding. This new information supports the growing evidence that clot-busting treatment may be safe for patients taking novel blood thinners.

Health-Related Quality of Life and Satisfaction in Atrial Fibrillation Patients on Anticoagulant Therapy: Differences between Vitamin K Antagonists and Direct Oral Anticoagulants; Results from the Multicentre REGUEIFA Registry.

Background: Oral anticoagulation (OAC) is pivotal in the clinical management of atrial fibrillation (AF) patients. Vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) prevent thromboembolic events, but information about the quality of life (QoL) and patient satisfaction in relation with the anticoagulant treatment is limited. Methods: REGUEIFA is a prospective, observational, and multicentre study that included patients with AF treated by cardiologists. We included patients treated with VKAs or DOACs. The EuroQol-5D (EQ-5D) questionnaire evaluated QoL, and the Anti-Clot Treatment Scale (ACTS) questionnaire investigated patient satisfaction with OAC. Results: A total of 904 patients were included (532 on VKA and 372 on DOACs). A total of 846 patients completed the EQ-5D questionnaire, with results significantly worse in patients on VKAs than on DOACs: more mobility limitations (37.6% vs. 24.2%, p < 0.001), more restriction in usual activities (24.7% vs. 18.3%, p = 0.026), more pain/discomfort (31.8% vs. 24.2%, p = 0.015), a lower visual analogue scale (VAS) score (66.4 ± 16.21 vs. 70.8 ± 15.6), and a lower EQ-D5 index (0.79 ± 0.21 vs. 0.85 ± 0.2, p < 0.001). After adjusting for baseline characteristics, VKA treatment was not an independent factor towards worse EQ-5D results. Also, 738 patients completed the ACTS questionnaire, and burden and profit scores were lower in patients on VKAs than for DOACs (52.1 ± 8.4 vs. 55.5 ± 6.8, p < 0.001 and 11.1 ± 2.4 vs. 11.8 ± 2.6, p < 0.001, respectively). The negative impact score was higher for VKAs than for DOACs (1.8 ± 1.02 vs. 1.6 ± 0.99, p < 0.001), with a general positive impact score lower for VKAs than for DOACs (3.6 ± 0.96 vs. 3.8 ± 1.02, p < 0.001). Conclusions: Patients on VKA have more comorbidity and worse EQ-5D and VAS scores than those on DOACs. VKA has a greater burden and higher negative impact on the patient's life than DOACs.

Effects of atrial fibrillation screening according to thyroid function: Post-hoc analysis of the randomized LOOP study.

PURPOSE: Subclinical thyroid dysfunction is a marker for atrial fibrillation (AF) and stroke risk. This study explored the effects of AF screening according to thyroid-stimulating hormone (TSH) levels. METHODS: An AF screening trial (the LOOP study) was analyzed post-hoc according to baseline TSH. The primary outcome was stroke or systemic embolism (SE). Secondary outcomes included major bleeding, all-cause death, and the combination of stroke, SE, and cardiovascular death. RESULTS: TSH measurement was available in 6003 of 6004 trial participants, 1500 randomized to implantable loop recorder (ILR) screening for AF and anticoagulation upon detection vs. 4503 to usual care; mean age was 74.7±4.1 years and 2836 (47%) were women. AF detection was approximately triple for ILR vs usual care across TSH tertiles (adjusted p-interaction=0.44). In the first tertile, screening was associated with decreased risk of the primary outcome (hazard ratio 0.52 [0.30-0.90]; p=0.02) and stroke, SE, or cardiovascular death (hazard ratio 0.54 [0.34-0.84]; p=0.006) compared to usual care, while no effect was observed among participants with higher TSH (adjusted p-interaction 0.03 and 0.01, respectively). There was no effect on other outcomes. Analyses of continuous TSH or excluding those with abnormal TSH or thyroid medication showed similar results. CONCLUSION: AF screening and subsequent treatment was associated with decreased stroke risk among participants with low TSH, though the yield of screening was similar across TSH levels. TSH may be useful as a marker to indicate benefit from AF screening vs. overdiagnosis and overtreatment. These findings should be considered exploratory and warrant further study. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT0203645.

Effect of Screening for Undiagnosed Atrial Fibrillation on Stroke Prevention.

BACKGROUND: Atrial fibrillation (AF) often remains undiagnosed, and it independently raises the risk of ischemic stroke, which is largely reversible by oral anticoagulation. Although randomized trials using longer term screening approaches increase identification of AF, no studies have established that AF screening lowers stroke rates. OBJECTIVES: To address this knowledge gap, the GUARD-AF (Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals) trial screened participants in primary care practices using a 14-day continuous electrocardiographic monitor to determine whether screening for AF coupled with physician/patient decision-making to use oral anticoagulation reduces stroke and provides a net clinical benefit compared with usual care. METHODS: GUARD-AF was a prospective, parallel-group, randomized controlled trial designed to test whether screening for AF in people aged ≥70 years using a 14-day single-lead continuous electrocardiographic patch monitor could identify patients with undiagnosed AF and reduce stroke. Participants were randomized 1:1 to screening or usual care. The primary efficacy and safety outcomes were hospitalization due to all-cause stroke and bleeding, respectively. Analyses used the intention-to-treat population. RESULTS: Enrollment began on December 17, 2019, and involved 149 primary care sites across the United States. The COVID-19 pandemic led to premature termination of enrollment, with 11,905 participants in the intention-to-treat population. Median follow-up was 15.3 months (Q1-Q3: 13.8-17.6 months). Median age was 75 years (Q1-Q3: 72-79 years), and 56.6% were female. The risk of stroke in the screening group was 0.7% vs 0.6% in the usual care group (HR: 1.10; 95% CI: 0.69-1.75). The risk of bleeding was 1.0% in the screening group vs 1.1% in the usual care group (HR: 0.87; 95% CI: 0.60-1.26). Diagnosis of AF was 5% in the screening group and 3.3% in the usual care group, and initiation of oral anticoagulation after randomization was 4.2% and 2.8%, respectively. CONCLUSIONS: In this trial, there was no evidence that screening for AF using a 14-day continuous electrocardiographic monitor in people ≥70 years of age seen in primary care practice reduces stroke hospitalizations. Event rates were low, however, and the trial did not enroll the planned sample size.(Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals [GUARD-AF]; NCT04126486).

Benefits and limitations of implantable loop recorders in the very elderly.

BACKGROUND: Implantable loop recorder (ILR) allows rhythm-monitoring up to 3 years. They are recommended in patients with recurrent syncope and for the detection of atrial fibrillation (AF) in patients with cryptogenic thromboembolic events. AF and syncope occur more often in elderly patients. However, data in this cohort is limited. METHODS AND RESULTS: All patients ≥ 80 years undergoing ILR-implantation between 2011 and 2022 in our center were included. Permanent pacemaker implantation (PPI) and oral anticoagulation due AF were defined as primary endpoints. Forty-five patients ≥ 80 years were included, 33 because of recurrent syncope and 12 because of suspected AF. The average follow up (FU) was 17.6 months. Overall in 22 patients, ILR-implantation led to a therapeutic consequence (48.9%). In the 12 patients who underwent ILR-implantation for detection of AF, AF was detected in nine patients (75%). In the 33 elderly patients who received ILR-implantation after syncope, 11 underwent PPI during FU (33.3%). One patient accidentally removed the ILR himself via the implantation-wound, and no other ILR-related complications were observed. CONCLUSION: ILR are effective and safe in elderly patients. AF was often found in patients with suspected AF, especially in patients after catheter ablation of only documented atrial flutter (AFlu). PPI-rate was high in patients with recurrent syncope and ILR-implantation. Further investigations are necessary to determine whether PPI may be considered in elderly patients with syncope even in the absence of a bifascicular block.

Apixaban, edoxaban and rivaroxaban but not dabigatran are associated with higher mortality compared to vitamin-K antagonists: A retrospective German claims data analysis.

BACKGROUND: Vitamin-K antagonists (VKAs) have widely been replaced by non-VKA oral anticoagulants (NOACs). This includes Austria, Germany and Switzerland, where as VKA, instead of warfarin, the much longer-acting phenprocoumon is used, which was not compared to NOACs in clinical trials. METHODS: Using administrative data from a large German health insurance, we included all anticoagulation-naïve patients with a first prescription of a NOAC or VKA between 2012 and 2020. We analysed overall survival, major adverse cardiac and cerebrovascular events, major thromboembolic events and major bleeding. RESULTS: Overall, 570,137 patients were included (apixaban: 26.9%, dabigatran: 4.6%, edoxaban: 8.8%, rivaroxaban: 39.1% and VKA: 20.7% of these 99.4% phenprocoumon). In the primary analysis using a 1:1 propensity score matching-cohort (PSM-cohort), a significantly higher overall mortality was found for apixaban, edoxaban and rivaroxaban (all p < 0.001) but not for dabigatran (p = 0.13) compared to VKA. In this PSM-cohort, 5-year mortality was 22.7% for apixaban versus 12.7% for VKA, 19.5% for edoxaban versus 11.4% for VKA, 16.0% for rivaroxaban versus 12.3% for VKA (all p < 0.001) and 13.0% for dabigatran versus 12.8% for VKA (p = 0.06). The observed effect was confirmed in sensitivity analyses using un-weighted and three different weighted Fine-Gray regression models on the basis of the entire cohort. CONCLUSIONS: In this large real-world analysis, apixaban, edoxaban and rivaroxaban, but not dabigatran, were associated with worse survival compared to VKA. These findings, consistent with a few other studies including phenprocoumon, cast profound doubts on the unreflected, general use of NOACs. Randomized trials should assess whether phenprocoumon might actually be superior to NOACs.

Anticoagulation in device-detected atrial fibrillation with or without vascular disease: a combined analysis of the NOAH-AFNET 6 and ARTESiA trials.

BACKGROUND AND AIMS: The optimal antithrombotic therapy in patients with device-detected atrial fibrillation (DDAF) is unknown. Concomitant vascular disease can modify the benefits and risks of anticoagulation. METHODS: These pre-specified analyses of the NOAH-AFNET 6 (n=2534 patients) and ARTESiA (n=4012 patients) trials compared anticoagulation to no anticoagulation in patients with DDAF with or without vascular disease, defined as prior stroke/transient ischemic attack, coronary or peripheral artery disease. Efficacy outcomes were the primary outcomes of both trials, a composite of stroke, systemic arterial embolism (SE), myocardial infarction, pulmonary embolism or cardiovascular death, and stroke or SE. Safety outcomes were major bleeding or major bleeding and death. RESULTS: In patients with vascular disease (NOAH-AFNET 6 56%, ARTESiA 46.0%), stroke, myocardial infarction, systemic or pulmonary embolism, or cardiovascular death occurred at 3.9%/patient-year with and 5.0%/patient-year without anticoagulation (NOAH-AFNET 6), and 3.2%/patient-year with and 4.4%/patient-year without anticoagulation (ARTESiA). Without vascular disease, outcomes were equal with and without anticoagulation (NOAH-AFNET 6 2.7%/patient-year, ARTESiA 2.3%/patient-year in both randomised groups). Meta-analysis found consistent results across both trials (I2heterogeneity=6%) with a trend for interaction with randomised therapy (pinteraction=0.08). Stroke/SE behaved similarly. Anticoagulation increased major bleeding in vascular disease patients (edoxaban 2.1%/patient-year, no anticoagulation 1.3%/patient-year; apixaban 1.7%/patient-year; no anticoagulation 1.1%/patient-year; incidence rate ratio 1.55 [1.10-2.20]) and without vascular disease (edoxaban 2.2%/patient-year; no anticoagulation 0.6%/patient-year; apixaban 1.4%/patient-year; no anticoagulation 1.1%/patient-year, incidence rate ratio 1.93 [0.72-5.20]). CONCLUSIONS: Patients with DDAF and vascular disease are at higher risk of stroke and cardiovascular events and may derive a greater benefit from anticoagulation than patients with DDAF without vascular disease.

Left Atrial Appendage Closure Compared With Oral Anticoagulants for Patients With Atrial Fibrillation: A Systematic Review and Network Meta-Analysis.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) has been suggested as an alternative to long-term oral anticoagulation for nonvalvular atrial fibrillation, but comparative data remain scarce. We aimed to assess ischemic and bleeding outcomes of LAAC compared with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) for the prevention of cardioembolic events in patients with atrial fibrillation. METHODS AND RESULTS: Embase and MEDLINE were searched for randomized trials comparing LAAC, VKAs, and DOACs. The primary efficacy end point was any stroke or systemic embolism. Treatment effects were calculated from a network meta-analysis and ranked according to the surface under the cumulative ranking curve. Seven trials and 73 199 patients were included. The risk of the primary end point was not statistically different between LAAC versus VKAs (odds ratio [OR], 0.92 [95% CI, 0.62-1.50]) and LAAC versus DOACs (OR, 1.11 [95% CI, 0.71-1.73]). LAAC and DOACs resulted in similar risk of major or minor (OR, 0.93 [95% CI, 0.61-1.42]) and major bleeding (OR, 0.92 [95% CI, 0.58-1.46]); however, after exclusion of procedural bleeding, bleeding risk was significantly lower in those undergoing LAAC. Both LAAC and DOACs reduced the risk of all-cause death  compared with VKAs (LAAC versus VKAs: OR, 0.70 [95% CI, 0.53-0.91]; DOACs versus VKAs: OR, 0.90 [95% CI, 0.85-0.95], respectively). DOACs ranked as the best treatment for stroke or systemic embolism prevention (66.9%) and LAAC for reducing major bleeding (63.9%) and death (96.4%). CONCLUSIONS: As a nonpharmacological alternative to oral anticoagulation for atrial fibrillation, LAAC showed similar efficacy and safety compared with VKAs or DOACs. Prospective confirmation from larger studies is warranted.

Favorable safety profile of NOAC therapy in patients after tricuspid transcatheter edge-to-edge repair.

BACKGROUND: Transcatheter edge-to-edge repair for severe tricuspid regurgitation (TR) is a new treatment option (t-TEER). Data on optimal antithrombotic therapy after t-TEER in patients with an indication for anticoagulation are scarce and evidence-based guideline recommendations are lacking. We sought to investigate efficacy and safety of novel oral anticoagulation (NOAC) and vitamin-K-antagonists (VKA) in patients undergoing t-TEER. METHODS: Among 78 consecutive patients with t-TEER of severe TR, 69 patients were identified with concomitant indication for oral anticoagulation. Outcomes of these patients treated with NOAC or VKA were compared over a median follow-up period of 327 (177-460) days. RESULTS: Despite elevated thromboembolic and bleeding risk scores (CHA2DS2-VASc 4.2 ± 1.1, HEMORR2HAGES 3.0 ± 1.0 and HAS-BLED 2.1 ± 0.8), only one major bleeding incidence occurred under NOAC therapy. The risk for overall (NOAC 8% vs. VKA group 26%, p = 0.044) and major bleeding events (NOAC 2% vs. VKA 21%, p = 0.010) was significantly lower in the NOAC compared to the VKA group. No significant difference was found between NOAC and VKA treatment in terms of mortality (NOAC 18% vs. VKA 16%, p = 0.865) or the combined endpoint of death, heart failure hospitalization, stroke, embolism, thrombosis, myocardial infarction, and severe bleeding (NOAC 48% vs. VKA 42%, p = 0.801). A comparison between apixaban (n = 27) and rivaroxaban (n = 16) treated patients revealed no significant differences between NOAC substances (all bleeding events apixaban 7% vs. rivaroxaban 13%, p = 0.638). CONCLUSION: Results of this study indicate that NOACs may offer a favorable risk-benefit profile for patients with concomitant indication for anticoagulation therapy following t-TEER.

Clinical outcome and intraprocedural characteristics of left atrial appendage occlusion: a comparison between single-occlusive plug-type and dual-occlusive disc-type devices.

Background: Percutaneous interventional left atrial appendage occlusion (LAAO) is a reliable, safe, and effective alternative for stroke prevention in selected patients with atrial fibrillation (AF). Methods: In a retrospective observational study, 149 patients underwent LAAO between 2016 and 2022 at the Department of Cardiology of the Charité-Universitätsmedizin Berlin, Campus Virchow, with AF for prevention of thromboembolic complications. We compared patient characteristics, intraoperative details and postoperative outcomes between single-occlusive plug-type (SOPT) and dual-occlusive disc-type (DODT) devices. Results: In all patients, the device implantation was successful. 60 patients received a SOPT occluder, including Watchman (35%) and Watchman FLX Occluders (65%), while 89 patients received a DODT occluder, including Amplatzer Cardiac Plug (37.1%), the Amplatzer Amulet (25.8%), and the LAmbre occluder (37.1%) systems. Procedure duration was significantly longer for DODT occluder implantation (49 ± 33 vs. 41 ± 25 min, p = 0.018). There were no in-hospital deaths or thromboembolic events reported after LAAO in both groups. Beyond that, a low rate of bleeding or access-side-related complications and pericardial tamponades were observed. Anticoagulation at discharge varied. About 60.8% of patients received dual antiplatelet therapy at hospital discharge, and 33.1% received direct oral anticoagulants. A 6-month follow-up was obtained in 85% of the patients. All implanted devices were in the desired position. However, in 5.7% of the patients, a device-related thrombus formation was detected in the SOPT group, while no thrombus was seen in the DODT group (p = 0.11). Thromboembolic events were noticed in 3.1%, without any difference between the device types. There was a statistically non-significant trend for less residual device leaks after SOPT vs. DODT implantation (no leak in 71.7% vs. 62.2%, p = 0.07; minor leaks <5 mm, 9.4% vs. 20.3%, p = 0.1). In the SOPT group, less bleeding complications were reported after LAAO (11.3% vs. 17.6%, p = 0.1). Conclusion: Our data suggest the safety and efficiency of LAAO with a very high procedural implantation success rate irrespective of the used LAA device. Furthermore, no relevant procedural or device-related complication occurred during the 6-month follow-up in all patients.

Community-based analysis of stroke prevention and effect of public interventions in atrial fibrillation: results from the ARENA project.

BACKGROUND: Community-based interventions may promote awareness and adherence to atrial fibrillation (AF)-related therapies, potentially reducing adverse events. The ARENA project investigated the health status, therapies and events in AF patients in the Rhein-Neckar Region, Germany. The subproject "ARENA intervention" studied the effect of community-based interventions on AF-associated outcomes. METHODS: From 2016 onward, patients with diagnosed AF were recruited for the observational ARENA registry. In 2018, an intervention period was initiated involving population-based information campaigns on AF diagnosis and therapies. The "control group" was recruited prior to initiation, and the "intervention group" afterward. Patients underwent standardized follow-up > 1 year after recruitment. Clinical outcomes, therapy and quality of life were compared between the two groups. RESULTS: A total of 2769 patients were included. This real-world cohort showed high adherence to oral anticoagulation therapy (OAC) and an increased use of NOACs over vitamin K antagonists over time. In the intervention group (n = 1362), more patients continued OAC at follow-up (87.1% vs. 81.5%, P = 0.002). However, this difference was not significant in the patient subgroup with class I/IIa indications for OAC (90.1% vs. 87.5%, P = 0.11). AF-related re-hospitalization was lower in the intervention group (6.8% vs. 12.3%, P < 0.001). There was no significant difference in quality of life. AF-related anxiety was reduced at follow-up. Of note, nearly a quarter of all patients stated that ARENA had influenced their health perception. CONCLUSION: Tailored community-based campaigns may raise awareness for AF-related health issues, supporting therapy adherence. Future public strategies to improve quality of life in AF patients should be investigated, as the ARENA project hints at a potential benefit of population-based campaigns. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT02978248).

A Systematic Review of Ongoing Registered Research Studies on Post-Operative Atrial Fibrillation after Cardiac Surgery.

Background/Objectives: New-onset atrial fibrillation (AF) after cardiac surgery is associated with patient-important outcomes. Uncertainty persists regarding its prevention, detection, and management. This review seeks to identify, compile, and describe ongoing registered research studies involving patients with or at risk for post-operative AF (POAF) after cardiac surgery. Methods: We searched clinical trial registries in January 2023 for studies focusing on POAF prediction, prevention, detection, or management. We extracted data from each record and performed descriptive analyses. Results: In total, 121 studies met the eligibility criteria, including 82 randomized trials. Prevention studies are the most common (n = 77, 63.6%), followed by prediction (n = 21, 17.4%), management (n = 16, 13.2%), and detection studies (n = 7, 5.8%). POAF after cardiac surgery is an area of active research. Conclusions: There are many ongoing randomized prevention studies. However, two major clinical gaps persist; future randomized trials should compare rate and rhythm control in patients who develop POAF, and long-term follow-up studies should investigate strategies to monitor for AF recurrence in patients with POAF.

Left atrial appendage closure for stroke prevention in atrial fibrillation: current status and perspectives.

Atrial fibrillation (AF) is associated with an increased risk of stroke and systemic embolism, and the left atrial appendage (LAA) has been identified as a principal source of thromboembolism in these patients. While oral anticoagulation is the current standard of care, LAA closure (LAAC) emerges as an alternative or complementary treatment approach to reduce the risk of stroke or systemic embolism in patients with AF. Moderate-sized randomized clinical studies have provided data for the efficacy and safety of catheter-based LAAC, largely compared with vitamin K antagonists. LAA device iterations, advances in pre- and peri-procedural imaging, and implantation techniques continue to increase the efficacy and safety of LAAC. More data about efficacy and safety of LAAC have been collected, and several randomized clinical trials are currently underway to compare LAAC with best medical care (including non-vitamin K antagonist oral anticoagulants) in different clinical settings. Surgical LAAC in patients with AF undergoing cardiac surgery reduced the risk of stroke on background of anticoagulation therapy in the LAAOS III study. In this review, we describe the rapidly evolving field of LAAC and discuss recent clinical data, ongoing studies, open questions, and current limitations of LAAC.

Atrial fibrillation burden: a new outcome predictor and therapeutic target.

Atrial fibrillation (AF), the most common sustained cardiac arrhythmia, is not a dichotomous disease trait. Technological innovations enable long-term rhythm monitoring in many patients and can estimate AF burden. These technologies are already used to detect and monitor AF. This review describes the relation between AF burden and outcomes and potential effects of AF burden reduction. A lower AF burden is associated with a lower risk of stroke and heart failure in patients with AF: stroke risk without anticoagulation is lower in patients with device-detected AF and a low AF burden (stroke rate 1%/year) than in patients with persistent and permanent AF (stroke rate 3%/year). Paroxysmal AF shows intermediate stroke rates (2%/year). Atrial fibrillation burden-reducing interventions can reduce cardiovascular outcomes in patients with AF: early rhythm control reduces cardiovascular events including stroke and heart failure in patients with recently diagnosed AF and cardiovascular conditions. In patients with heart failure and AF, early rhythm control and AF ablation, interventions that reduce AF burden, reduce mortality and heart failure events. Recent technological innovations allow to estimate AF burden in clinical care, creating opportunities and challenges. While evidence remains limited, the existing data already suggest that AF burden reduction could be a therapeutic goal. In addition to anticoagulation and treatment of cardiovascular conditions, AF burden reduction emerges as a therapeutic goal. Future research will define the AF burden that constitutes a relevant risk of stroke and heart failure. Technologies quantifying AF burden need careful validation to advance the field.

Advances in the medical treatment and diagnosis of intracranial hemorrhage associated with oral anticoagulation.

INTRODUCTION: With the increasing prevalence of atrial fibrillation (AF), it entails expanding oral anticoagulants (OACs) use, carrying a higher risk of associated hemorrhagic events, including intracranial hemorrhage (ICH). Despite advances in OACs development with a better safety profile and reversal agent for these anticoagulants, there is still no consensus on the optimal management of patients with OACs-associated ICH. AREAS COVERED: In this review, the authors have carried out an exhaustive search on the advances in recent years. The authors provide an update on the management of ICH in anticoagulated patients, as well as an update on the latest evidence on anticoagulation resumption, recent therapeutic strategies, and investigational drugs that could play a role in the future. EXPERT OPINION: Following an ICH event in an anticoagulated patient, a comprehensive clinical evaluation is imperative. Anticoagulation should be promptly withdrawn and reversed. Once the patient is stabilized, a reintroduction of anticoagulation should be considered, typically within a timeframe of 4-8 weeks, if feasible. If re-anticoagulation is not possible, alternative options such as Left Atrial Appendage Occlusion are available.

Aspirin-Free Strategy for Percutaneous Coronary Intervention in Patients With Oral Anticoagulation: Prespecified Subgroup Analysis From the STOPDAPT-3 Trial.

BACKGROUND: The effects of aspirin-free strategy on bleeding and cardiovascular events in patients undergoing percutaneous coronary intervention with oral anticoagulation (OAC) have not been fully elucidated. METHODS AND RESULTS: We conducted the prespecified subgroup analysis based on the use of OAC, including vitamin K antagonist and direct oral anticoagulants, within 7 days before percutaneous coronary intervention in the STOPDAPT-3 (Short and Optimal Duration of Dual Antiplatelet Therapy-3) trial, which randomly compared prasugrel monotherapy (2984 patients) to dual antiplatelet therapy (DAPT) with prasugrel and aspirin (2982 patients) in patients with acute coronary syndrome or high bleeding risk. The coprimary end points were major bleeding events (Bleeding Academic Research Consortium types 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) at 1 month. Among 5966 study patients, there were 530 patients (8.9%) with OAC (no aspirin: N=248, and DAPT: N=282) and 5436 patients (91.1%) without OAC (no aspirin: N=2736, and DAPT: N=2700). Regardless of the use of OAC, the effects of no aspirin compared with DAPT were not significant for the bleeding end point (OAC: 4.45% and 4.27%, hazard ratio [HR], 1.04 [95% CI, 0.46-2.35]; no-OAC: 4.47% and 4.75%, HR, 0.94 [95% CI, 0.73-1.20]; P for interaction=0.82), and for the cardiovascular end point (OAC: 4.84% and 3.20%, HR, 1.53 [95% CI, 0.64-3.62]; no-OAC: 4.06% and 3.74%, HR, 1.09 [95% CI 0.83-1.42]; P for interaction =0.46). CONCLUSIONS: The no-aspirin strategy compared with the DAPT strategy failed to reduce major bleeding events irrespective of the use of OAC. There was a numerical excess risk of the no-aspirin strategy relative to the DAPT strategy for cardiovascular events in patients with OAC.

Assessment of patient-reported treatment burden in patients with coronary artery disease.

Introduction: Patient-reported treatment burden (TBN) refers to the patient's time and effort invested in the management of their chronic health conditions. The aim of this research was to explore TBN in patients with coronary artery disease (CAD). Methods: Consecutive patients with chronic medical condition(s) were invited to complete the study questionnaires (TBN and EQ-5D). Results: Of 514 enrolled patients, 116 (22.6%) patients had CAD. The mean TBN score for CAD vs. non-CAD was 40.49 ±21.54 and 46.17 ±21.44 (p = 0.023), respectively. Conclusions: Patients with CAD could have a lower TBN in comparison to patients with other chronic medical conditions.

Two Cases With Recurrent Challenges: Unraveling the Complexity of Heyde Syndrome With Rebleeding.

Heyde syndrome is characterized by the association between aortic stenosis and gastrointestinal bleeding. This report examines two cases of Heyde syndrome in elderly females who experience bleeding recurrence within months following aortic valve replacement (AVR). The discussion highlights the controversies surrounding the optimal management of Heyde syndrome, particularly in the context of AVR type (surgical vs. transcatheter) and postoperative complications. The report underscores the need for a multidisciplinary approach to Heyde syndrome management and the importance of individualized treatment strategies considering patient-specific factors such as lesion location and postoperative complications.

Impact of prior oral anticoagulation on admission stroke severity in patients with atrial fibrillation.

BACKGROUND AND AIMS: In patients with atrial fibrillation, oral anticoagulation therapy is indicated for both primary and secondary prevention of stroke/systemic embolism. Though direct oral anticoagulants with greater safety and efficacy than warfarin were introduced into clinical practice at the beginning of the last decade, even now not all patients with AF have adequate preventative anticoagulant treatment. The primary goal of this study was to evaluate the impact of prior use of oral anticoagulants on admission stroke severity in those with AF. Other aims were, inter alia, to assess the trend in atrial fibrillation prevalence in the years of the HISTORY trials 2012-2021 carried out in the Czech Republic and use of oral anticoagulants (OAC) in ischemic stroke (IS) patients. METHODS: We analyzed consecutive ischemic stroke patients who had been enrolled in the HISTORY (Heart and Ischemic STrOke Relationship studY) study registered on ClinicalTrials.gov (identifier NCT01541163) in the year 2012 and carried out a yearly comparison (detailed in the text). RESULTS: In total, there were 1059 patients (55.9% males, mean age 71.7±12.8). There was no significant difference over the time period in rate of known (18.3 vs. 16.5%, P=0.442) or newly detected AF (17.0 vs. 16.0%, P=0.665), but sigificantly more patients with known AF were treated with oral anticoagulants before IS in the year 2021 (32.1 vs. 70.7%, P<0.0001), and direct oral anticoagulants (3.6 vs. 35.4%, P<0.0001). The number of patients with atrial fibrillation had not changed significantly over the years (26.2 vs. 31.3%). Patients on OAC had a lower median admission score on the National Institutes of Health Stroke Scale (NIHSS) than those not using an oral anticoagulant (6 vs. 16, P=0.0004) in 2021. CONCLUSIONS: There was no significant upward trend in atrial fibrillation in stroke patients admitted between 2012 and 2021, but patients with known AF were significantly more frequently treated with oral anticoagulants and direct oral anticoagulants (DOAC) in 2021. Patients on OAC had lower admission NIHSS scores than those not using any anticoagulent in the year 2021. The difference in the median admission NIHSS between the patients on OAC and those without OAC treatment was not significant in the year 2012 (6 vs. 12, P=0.066). This might be related to the fact that substantially fewer patients in 2012 were on DOACs, which are considered more effective than warfarin.