Perioperative Management in Patients with Atrial Fibrillation Treated with Non-Vitamin K Antagonist Oral Anticoagulants Undergoing Minor Bleeding Risk Procedure: Rationale and Protocol for the PERIXa Study.

Background: While treatment interruption of non-vitamin K antagonist oral anticoagulants (NOACs) for elective surgery or procedures among patients with atrial fibrillation (AF) is becoming more prevalent, there remains insufficient evidence regarding the optimal perioperative management of NOACs, particularly procedures with minor bleeding risks. Objective: This study aims to evaluate the safety and effectiveness of a simplified, standardized protocol for perioperative management of direct factor Xa inhibitors in patients, with AF undergoing procedures associated with minor bleeding risk. Methods: This multicenter, prospective single-arm registry study plans to enroll patients undergoing procedures with minor bleeding risk who were prescribed direct factor Xa inhibitors for AF. The procedures with minor bleeding risk will include gastrointestinal endoscopy for diagnostic purposes, selected dental procedures, and ocular surgery for cataracts or glaucoma. For apixaban, patients will withhold the last evening dose and resume either from the evening dose of the procedure day or the following morning, depending on the bleeding risk of the patient. For edoxaban or rivaroxaban, patients will withhold only a single dose on the procedure day. The primary outcome is the occurrence of major bleeding events within 30 days. Secondary outcomes include systemic thromboembolism, all-cause mortality, and a composite of major and clinically relevant non-major bleeding events. Conclusion: This study has the potential to generate evidence regarding the safety of perioperative management for patients, with AF undergoing procedures associated with minor bleeding risk. Trial Registration: Clinicaltrials.gov: NCT05801068.

Association between body mass index and results of cryoballoon ablation in Korean patients with atrial fibrillation: an analysis from the Korean Heart Rhythm Society Cryoablation registry.

AIMS: Pulmonary vein isolation using cryoablation is effective and safe in patients with atrial fibrillation (AF). Although both obesity and underweight are associated with a higher risk for incident AF, there is limited data on the efficacy and safety following cryoablation according to body mass index (BMI) especially in Asians. METHODS AND RESULTS: Using the Korean Heart Rhythm Society Cryoablation registry, a multicentre registry of 12 tertiary hospitals, we analysed AF recurrence and procedure-related complications after cryoablation by BMI (kg/m2) groups (BMI < 18.5, underweight, UW; 18.5-23, normal, NW; 23-25, overweight, OW; 25-30, obese Ⅰ, OⅠ; ≥30, obese Ⅱ, OⅡ). A total of 2648 patients were included (median age 62.0 years; 76.7% men; 55.6% non-paroxysmal AF). Patients were categorized by BMI groups: 0.9% UW, 18.7% NW, 24.8% OW, 46.1% OI, and 9.4% OII. Underweight patients were the oldest and had least percentage of non-paroxysmal AF (33.3%). During a median follow-up of 1.7 years, atrial arrhythmia recurred in 874 (33.0%) patients (incidence rate, 18.9 per 100 person-years). After multivariable adjustment, the risk of AF recurrence was higher in UW group compared with NW group (adjusted hazard ratio, 95% confidence interval; 2.55, 1.18-5.50, P = 0.02). Procedure-related complications occurred in 123 (4.7%) patients, and the risk was higher for UW patients (odds ratio, 95% confidence interval; 2.90, 0.94-8.99, P = 0.07), mainly due to transient phrenic nerve palsy. CONCLUSION: Underweight patients showed a higher risk of AF recurrence after cryoablation compared with NW patients. Also, careful attention is needed on the occurrence of phrenic nerve palsy in UW patients.

Combination of early rhythm control and healthy lifestyle on the risk of stroke in elderly patients with new-onset atrial fibrillation: a nationwide population-based cohort study.

Background: The impact of early rhythm control (ERC) combined with healthy lifestyle (HLS) on the risk of ischemic stroke in elderly patients with atrial fibrillation (AF) remains unaddressed. Objective: To evaluate the impact of combined ERC and HLS on the risk of stroke in elderly patients with new-onset AF. Methods: Using the Korean National Health Insurance Service database, we included patients aged ≥75 years with new-onset AF from January 2009 to December 2016 (n = 41,315). Patients who received rhythm control therapy within 2 years of AF diagnosis were defined as the ERC group. Non-smoking, non-to-mild alcohol consumption (<105 g/week), and regular exercise were defined as HLS. Subjects were categorized into four groups: group 1 (without ERC and HLS, n = 25,093), 2 (HLS alone, n = 8,351), 3 (ERC alone, n = 5,565), and 4 (both ERC and HLS, n = 2,306). We assessed the incidence of ischemic stroke as the primary outcome, along with admissions for heart failure, all-cause death, and the composite of ischemic stroke, admission for heart failure, and all-cause death. Results: Median follow-up duration of the study cohort was 3.4 years. After adjusting for multiple variables, groups 2 and 3 were associated with a lower stroke risk (adjusted hazard ratio [aHR]: 95% confidence interval [CI]: 0.867, 0.794-0.948 and 0.713, 0.637-0.798, respectively) than that of group 1. Compared to Group 1, group 4 showed the lowest stroke risk (aHR: 0.694, 95% CI: 0.586-0.822) among all groups, followed by group 3 (0.713, 0.637-0.798) and group 2 (0.857, 0.794-0.948), respectively. Group 4 was associated with the lowest risk of all-cause death (aHR: 0.680, 95% CI: 0.613-0.754) and the composite outcome (aHR: 0.708, 95% CI: 0.649-0.772). Conclusion: ERC and HLS were associated with a lower risk of ischemic stroke in elderly patients with new-onset AF. Concurrently implementing ERC and maintaining HLS was associated with the lowest risk of death and the composite outcome, with a modest synergistic effect on stroke prevention.

Atrial fibrillation: comorbidities, lifestyle, and patient factors.

Modern anticoagulation therapy has dramatically reduced the risk of stroke and systemic thromboembolism in people with atrial fibrillation (AF). However, AF still impairs quality of life, increases the risk of stroke and heart failure, and is linked to cognitive impairment. There is also a recognition of the residual risk of thromboembolic complications despite anticoagulation. Hence, AF management is evolving towards a more comprehensive understanding of risk factors predisposing to the development of this arrhythmia, its' complications and interventions to mitigate the risk. This review summarises the recent advances in understanding of risk factors for incident AF and managing these risk factors. It includes a discussion of lifestyle, somatic, psychological, and socioeconomic risk factors. The available data call for a practice shift towards a more individualised approach considering an increasingly broader range of health and patient factors contributing to AF-related health burden. The review highlights the needs of people living with co-morbidities (especially with multimorbidity), polypharmacy and the role of the changing population demographics affecting the European region and globally.

Clonal haematopoiesis of indeterminate potential and atrial fibrillation: an east Asian cohort study.

BACKGROUND AND AIMS: Both clonal haematopoiesis of indeterminate potential (CHIP) and atrial fibrillation (AF) are age-related conditions. This study investigated the potential role of CHIP in the development and progression of AF. METHODS: Deep-targeted sequencing of 24 CHIP mutations (a mean depth of coverage = 1000×) was performed in 1004 patients with AF and 3341 non-AF healthy subjects. Variant allele fraction ≥ 2.0% indicated the presence of CHIP mutations. The association between CHIP and AF was evaluated by the comparison of (i) the prevalence of CHIP mutations between AF and non-AF subjects and (ii) clinical characteristics discriminated by CHIP mutations within AF patients. Furthermore, the risk of clinical outcomes-the composite of heart failure, ischaemic stroke, or death-according to the presence of CHIP mutations in AF was investigated from the UK Biobank cohort. RESULTS: The mean age was 67.6 ± 6.9 vs. 58.5 ± 6.5 years in AF (paroxysmal, 39.0%; persistent, 61.0%) and non-AF cohorts, respectively. CHIP mutations with a variant allele fraction of ≥2.0% were found in 237 (23.6%) AF patients (DNMT3A, 13.5%; TET2, 6.6%; and ASXL1, 1.5%) and were more prevalent than non-AF subjects [356 (10.7%); P < .001] across the age. After multivariable adjustment (age, sex, smoking, body mass index, diabetes, and hypertension), CHIP mutations were 1.4-fold higher in AF [adjusted odds ratio (OR) 1.38; 95% confidence interval 1.10-1.74, P < .01]. The ORs of CHIP mutations were the highest in the long-standing persistent AF (adjusted OR 1.50; 95% confidence interval 1.14-1.99, P = .004) followed by persistent (adjusted OR 1.44) and paroxysmal (adjusted OR 1.33) AF. In gene-specific analyses, TET2 somatic mutation presented the highest association with AF (adjusted OR 1.65; 95% confidence interval 1.05-2.60, P = .030). AF patients with CHIP mutations were older and had a higher prevalence of diabetes, a longer AF duration, a higher E/E', and a more severely enlarged left atrium than those without CHIP mutations (all P < .05). In UK Biobank analysis of 21 286 AF subjects (1297 with CHIP and 19 989 without CHIP), the CHIP mutation in AF is associated with a 1.32-fold higher risk of a composite clinical event (heart failure, ischaemic stroke, or death). CONCLUSIONS: CHIP mutations, primarily DNMT3A or TET2, are more prevalent in patients with AF than non-AF subjects whilst their presence is associated with a more progressive nature of AF and unfavourable clinical outcomes.

Prognostic implication of early recurrence after cryoballoon ablation in patients with atrial fibrillation.

BACKGROUND: It remains uncertain whether the implication of early recurrence and blanking period can be applied to patients with atrial fibrillation (AF) treated with cryoballoon ablation (CBA). We aimed to explore the prognostic value of early recurrence in patients with AF treated with CBA. METHODS: We studied consecutive AF patients who were treated with CBA between April 2019 and September 2020 in two tertiary medical institutes and followed for up to 12 months. The endpoint was the late recurrence of atrial arrhythmia, including AF, atrial flutter, and atrial tachycardia, following a 90-day blanking period. Atrial arrhythmia during the blanking period was defined as early recurrence and was not considered as an endpoint. RESULTS: This study included 406 patients with AF who underwent CBA. During the follow-up, 147 (36.2%) cases of late recurrence were observed. Of the 104 patients with early recurrence, 85 experienced late recurrence during follow-up. Early recurrence was associated with an increased risk of late recurrence in the univariate and multivariate analyses (P < 0.001). When we classified the patients into paroxysmal AF and persistent AF groups, early recurrence was still significantly associated with a higher risk of late recurrence (P = 0.005 and P < 0.001, respectively). CONCLUSION: Early recurrence after CBA was an independent risk factor for late recurrence in all patients as well as in those with paroxysmal AF and persistent AF. Therefore, further prospective studies could be considered to verify the risks and benefits of early rhythm control in patients with early recurrence.

Impact of Unhealthy Lifestyles on Patients with Atrial Fibrillation at Low Risk of Stroke: A Nationwide Cohort Study.

BACKGROUND: The impact of unhealthy lifestyles on clinical outcomes among patients with atrial fibrillation (AF) who are at low risk of stroke remains uncertain. The study objective was to evaluate the association between unhealthy lifestyles and clinical outcomes among low-risk AF patients with 0-1 non-sex risk factor of the CHA2DS2-VASc (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, prior Stroke or transient ischemic attack [TIA], Vascular disease, Age 65-74 years, female Sex;) score. METHODS: A total of 52,451 low-risk AF patients (mean age 51.6 ± 10.4 years) were evaluated with the National Health Insurance Service of the Republic of Korea database between 2009 and 2016. Using the survey on health habits, an unhealthy lifestyle score (ULS) was calculated by adding one point each if a respondent had a sedentary lifestyle, drinking, or smoking. The primary outcome was the composite of myocardial infarction, ischemic stroke, heart failure, and all-cause death. Multivariable Cox regression analysis was used to estimate the risk of the study outcome according to the ULS. RESULTS: There was a total of 12,792 (24.4%), 24,785 (47.3%), 11,602 (22.1%), and 3272 (6.2%) low-risk AF patients with 0 to 3 points of the ULS, respectively. The median follow-up period was 4.1 (2.1-6.1) years. Compared with the healthiest-lifestyle group (ULS 0), the other groups were associated with significantly higher risks of the primary outcome, with a gradually increasing trend according to the ULS (adjusted hazard ratio [95% confidence interval] =1.17 [1.05-1.31], 1.37 [1.21-1.56], 1.82 [1.53-2.17], for the groups with ULS 1, 2, and 3, respectively). CONCLUSION: Unhealthy lifestyles, including a sedentary lifestyle, drinking, and smoking, may synergistically impact poor clinical outcomes in AF patients who are deemed to be at low risk of stroke.

Novel laparoscopic renal denervation immediately reduces atrial fibrillation inducibility: a swine model study.

Catheter-based approaches may have inherent limitations in achieving effective renal denervation (RDN) and treatment of atrial fibrillation (AF). This study aimed to investigate the acute effects of novel laparoscopic RDN on modulating AF inducibility using a swine model. Four and five swine were randomly allocated to the sham and RDN groups, respectively. Each swine underwent measurement of the atrial effective refractory period (AERP) and AF induction tests using burst atrial pacing before and immediately after sham or RDN procedures with and without vagal nerve stimulation (VNS). A laparoscopic RDN procedure circumferentially ablated the renal nerves round the renal arteries using radiofrequency energy. There was no significant difference in the baseline AERP between the two groups (p > 0.05). Under VNS, AERP was significantly increased by 20 ms after laparoscopic RDN (95% CI = 0-30, p = 0.004). Compared to the sham group, the RDN group showed significantly reduced AF inducibility [OR (95% CI) = 0.32 (0.13-0.76) and 0.24 (0.11-0.57) with and without VNS, respectively]. After laparoscopic RDN, the duration of inducible AF episodes was significantly shortened from 28 (10-77) s to 7 (3-11) s (p < 0.001). The novel laparoscopic RDN can immediately reduce AF inducibility in a swine model.

Improved prognosis with integrated care management including early rhythm control and healthy lifestyle modification in patients with concurrent atrial fibrillation and diabetes mellitus: a nationwide cohort study.

BACKGROUND: Patients with concurrent atrial fibrillation (AF) and diabetes mellitus (DM) [AF-DM] have a high risk of cardiovascular and diabetes-related complications, but are less engaged in a comprehensive treatment approach. We evaluated the association of early rhythm control (ERC), lifestyle modification (LSM), and a combination of ERC and LSM with cardiovascular or diabetes-related complication risk in patients with AF-DM (type 2). METHODS: From the National Health Information Database, 47,940 patients diagnosed with AF-DM in 2009-2016 were included. We defined ERC as rhythm control therapy within two years of AF diagnosis and LSM as adherence to ≥ 2 of the healthy behaviors among non-current smoking, non-drinking, and regular exercise. We compared the primary (ischemic stroke) and secondary (macro- and microvascular complications, glycemic emergency, and all-cause death) outcomes in four groups: non-ERC and non-LSM (group 1), LSM only (group 2), ERC only (group 3), and both ERC and LSM (group 4). RESULTS: Of total, 10,617 (22%), 26,730 (55.8%), 2,903 (6.1%), and 7,690 (16.0%) were classified into groups 1 to 4, in sequence. The mean duration from AF diagnosis to ERC was 25.6 ± 75.5 days. During 4.0 (interquartile range: 2.5-6.2) years' follow-up, groups 2 and 3 were associated with 23% and 33% lower risks of stroke than group 1, respectively. Group 4 was associated with the lowest risk of stroke: hazard ratio (HR) 0.58, 95% confidence interval (CI) 0.51-0.67, p < 0.001. Regarding secondary outcomes, the lowest risks were also observed in group 4; macro- and microvascular complications, glycemic emergency, and all-cause death had HRs (95% CIs) of 0.63 (0.56-0.70), 0.88 (0.82-0.94), 0.72 (0.62-0.84), and 0.80 (0.73-0.87), respectively, all p < 0.001. CONCLUSIONS: For AF-DM patients, ERC and LSM exert a synergistic effect in preventing cardiovascular and diabetes-related complications with the greatest lowered risk of stroke. A comprehensive treatment approach should be pursued in AF-DM patients.

Catheter ablation and thoracoscopic ablation in long persistent atrial fibrillation with large left atrium.

Background: Pulmonary vein antrum isolation (PVAI) is the cornerstone of atrial fibrillation (AF) ablation, but the clinical outcomes of PVAI are unsatisfactory in patients with persistent AF and a large left atrium (LA). Objectives: We investigated the clinical outcomes following radiofrequency ablation (RFCA), cryoballoon ablation (CBA), and thoracoscopic maze in patients with persistent AF and a large LA. Methods: We included patients with consecutive persistent AF who had a large LA (LA diameter >50 mm) and underwent RFCA, CBA, or thoracoscopic maze surgery. In the RFCA group, additional linear ablation was performed at the physician's discretion. The endpoint was 12 months without recurrence of an atrial arrhythmia, including AF, atrial flutter, and atrial tachycardia, following a 90-day blanking period. Results: We recruited 89 persistent AF patients with a large LA who underwent RFCA (n = 32), CBA (n = 38), or the thoracoscopic maze procedure (n = 19). During the 12-month follow-up, 48 (53.9%) cases of AF recurrence were observed. There was no prognostic difference between groups (50.0% in RFCA vs. 52.6% in CBA vs. 63.2% in thoracoscopic maze, all P > 0.05). Early recurrence during the blanking period was a significant predictor of late recurrence for RFCA and CBA, but not for the thoracoscopic maze. Conclusion: In persistent AF patients with a large LA, we did not find a prognostic difference RFCA, CBA, or a thoracoscopic maze procedure in recurrence of atrial arrhythmia. Early recurrence predicted late recurrence in catheter ablation, but not in thoracoscopic maze.

Clustering of Unhealthy Lifestyle and the Risk of Adverse Events in Patients With Atrial Fibrillation.

Background: Little is known regarding the risk of clinical outcomes depending on the clustering of lifestyle behaviors after atrial fibrillation (AF) diagnosis. This study evaluated the association between a cluster of healthy lifestyle behaviors and the risk of adverse outcomes in patients with AF. Methods: Using the Korean National Insurance Service database, patients who were newly diagnosed with AF between 2009 and 2016 were included. A healthy lifestyle behavior score (HLS) was calculated by assigning 1 point each for non-current smoking, for non-drinking, and for performing regular exercise from the self-reported questionnaire in health examinations. The primary outcome was defined as major adverse cardiovascular event (MACE), including ischemic stroke, myocardial infarction, and hospitalization for heart failure. Results: A total of 208,662 patients were included; 7.1% in HLS 0, 22.7% in HLS 1, 58.6% in HLS 2, and 11.6% in HLS 3 groups. Patients with HLS 1, 2, and 3 were associated with a lower risk of MACE than those with HLS 0 (adjusted hazard ratio [95% confidence interval (CI)]: 0.788 [0.762-0.855], 0.654 [0.604-0.708], and 0.579 [0.527-0.636], respectively). After propensity score weighting, consistent results were observed. The risk reduction of healthy lifestyle combinations was consistently observed in various subgroups, regardless of the CHA2DS2-VASc score and oral anticoagulant use. Conclusion: Increased number of healthy lifestyle behaviors was significantly associated with lower MACE risk in patients with new-onset AF. These findings support the promotion of a healthy lifestyle to reduce the risk of adverse events in patients with AF.

Risk of Dementia After Smoking Cessation in Patients With Newly Diagnosed Atrial Fibrillation.

Importance: Incident atrial fibrillation (AF) is associated with an increased risk of dementia. However, data on the association between smoking cessation after AF diagnosis and dementia risk are limited. Objective: To evaluate the association between changes in smoking status after AF diagnosis and dementia risk. Design, Setting, and Participants: This nationwide cohort study with 126 252 patients used data from the Korean National Health Insurance Service database, including patients who had a national health checkup examination within 2 years before and after AF diagnosis between January 1, 2010, and December 31, 2016. Based on their smoking status, participants were classified as never smokers, ex-smokers, quit smokers, and current smokers. Ex-smokers were defined as those who had quit smoking before the first examination and remained quit until the second examination. Patients who were current smokers at the first health examination but had quit smoking before the second examination were classed as quit smokers. The index date was the second health examination. Patients were followed up until dementia, death, or the study period ended (December 31, 2017), whichever occurred first. Data were analyzed from January 13, 2020, to March 29, 2022. Exposures: Smoking cessation after newly diagnosed AF. Main Outcomes and Measures: Dementia, including Alzheimer disease and vascular dementia, was the primary outcome. Cox proportional hazards regression model was used to estimate hazard ratios. Results: A total of 126 252 patients (mean [SD] age, 62.6 [12.0] years; 61.9% men) were included in the analysis. The mean (SD) CHA2DS2-VASc score, which measures the risk of ischemic stroke, was 2.7 (1.7). Smoking status of the total study population was as follows: 65 579 never smokers (51.9%), 34 670 ex-smokers (27.5%), 8919 quit smokers (7.1%), and 17 084 current smokers (13.5%). During a median of 3 years of follow-up, dementia occurred in 5925 patients (1.11 per 1000 person-years). After multivariable adjustment, the risk of quit smokers was significantly lower than that of current smokers (hazard ratio, 0.83 [95% CI, 0.72-0.95]). Conclusions and Relevance: The findings of this cohort study suggest that all types of smoking were associated with a significantly higher risk of dementia in patients with new-onset AF. Smoking cessation after AF diagnosis was associated with a lower risk of dementia than among current smokers. These findings may support promoting smoking cessation to reduce dementia risk in patients with new-onset AF.

Low Risk of Dementia in Patients With Newly Diagnosed Atrial Fibrillation and a Clustering of Healthy Lifestyle Behaviors: A Nationwide Population-Based Cohort Study.

Background Limited data are available on the clinical impact of healthy lifestyle behaviors on the risk of dementia in patients with new-onset atrial fibrillation (AF). Here, we aimed to evaluate the association between a combination of healthy lifestyle behaviors and the risk of incident dementia in patients with AF. Methods and Results Using the Korean National Health Insurance database between 2009 and 2016, we identified 199 952 adult patients who were newly diagnosed as AF without dementia. Patients were categorized into 4 groups by healthy lifestyle behavior score (HLS) with 1 point each being assigned for no current smoking, alcohol abstinence, and regular exercise. The HLS 0, 1, 2, and 3 groups included 4.4%, 17.4%, 53.4%, and 24.8% of the patients, respectively. We performed an inverse probability of treatment weighting to balance covariates between HLS groups. The HLS 1, 2, and 3 groups were associated with a lower risk of dementia compared with the HLS 0 group (hazard ratio [HR], 0.769; 95% CI, 0.704-0.842 for HLS 1; HR, 0.770; 95% CI, 0.709-0.836 for HLS 2; and HR, 0.622; 95% CI, 0.569-0.679 for HLS 3). The risk of dementia showed a tendency to decrease with an increase in HLS (P-for-trend <0.001). Conclusions A clustering of healthy lifestyle behaviors was associated with a significantly lower risk of dementia in patients with new-onset AF. These findings support the promotion of a healthy lifestyle within an integrated care approach to AF patient management.

Risk of Atrial Fibrillation in Young Adults With Isolated Diastolic, Isolated Systolic, and Systolic-Diastolic Hypertension.

[Figure: see text].

Risk of Atrial Fibrillation According to Cancer Type: A Nationwide Population-Based Study.

BACKGROUND: Patients with cancer have an increased risk of atrial fibrillation (AF). However, there is a paucity of information regarding the association between cancer type and risk of AF. OBJECTIVES: This study sought to evaluate the risk of AF according to the type of cancer. METHODS: We enrolled 816,811 patients who were diagnosed with cancer from the Korean National Health Insurance Service database between 2009 and 2016. Age- and sex-matched noncancer control subjects (1:2; n = 1,633,663) were also selected. Newly diagnosed AF was identified based on the type of cancer. RESULTS: During a median follow-up of 4.5 years, AF was newly diagnosed in 25,356 patients with cancer (6.6 per 1,000 person-years). In multivariable Fine and Gray's regression analysis, cancer was an independent risk factor for incident AF (adjusted subdistribution hazard ratio [aHR]: 1.63; 95% confidence interval [CI]: 1.61 to 1.66). Multiple myeloma showed a higher association with incident AF (aHR: 3.34; 95% CI: 2.98 to 3.75). Esophageal cancer showed the highest risk among solid cancers (aHR: 2.69; 95% CI: 2.45 to 2.95), and stomach cancer showed the lowest association with AF risk (aHR: 1.27; 95% CI 1.23 to 1.32). CONCLUSIONS: Although patients with cancer were found to have a higher risk of AF, the impact on AF development varied by cancer type.

Self-rechargeable cardiac pacemaker system with triboelectric nanogenerators.

Self-powered implantable devices have the potential to extend device operation time inside the body and reduce the necessity for high-risk repeated surgery. Without the technological innovation of in vivo energy harvesters driven by biomechanical energy, energy harvesters are insufficient and inconvenient to power titanium-packaged implantable medical devices. Here, we report on a commercial coin battery-sized high-performance inertia-driven triboelectric nanogenerator (I-TENG) based on body motion and gravity. We demonstrate that the enclosed five-stacked I-TENG converts mechanical energy into electricity at 4.9 µW/cm3 (root-mean-square output). In a preclinical test, we show that the device successfully harvests energy using real-time output voltage data monitored via Bluetooth and demonstrate the ability to charge a lithium-ion battery. Furthermore, we successfully integrate a cardiac pacemaker with the I-TENG, and confirm the ventricle pacing and sensing operation mode of the self-rechargeable cardiac pacemaker system. This proof-of-concept device may lead to the development of new self-rechargeable implantable medical devices.

Smoking Cessation after Diagnosis of New-Onset Atrial Fibrillation and the Risk of Stroke and Death.

Limited data are available regarding the impact of smoking cessation after atrial fibrillation (AF) diagnosis on clinical outcomes. Using the Korean National Health Insurance Service database, we included patients newly diagnosed with AF and categorized them into four groups as follows: (i) never smokers, (ii) ex-smokers, (iii) smoking cessation after AF diagnosis ("quitters"), and (iv) current smokers. The primary outcomes were incident ischemic stroke and all-cause death during follow-up. Fatal ischemic stroke and death from cerebrovascular events were evaluated as secondary outcomes. Among 97,637 patients (mean age, 61 years; mean CHA2DS2-VASc score, 2.3), 6.9% stopped smoking after AF diagnosis. The mean follow-up duration was 3.2 ± 2.0 years. After multivariable adjustment, quitters had lower risks of ischemic stroke (hazard ratio (HR), 0.702; 95% confidence interval (CI), 0.595-0.827) and all-cause death (HR, 0.842; 95% CI, 0.748-0.948) than current smokers. Quitters after AF diagnosis were associated with lower risks of fatal ischemic stroke (HR, 0.454; 95% CI, 0.287-0.718) and death from cerebrovascular events (HR, 0.664; 95% CI, 0.465-0.949) compared with current smokers. Quitting smoking may reduce the risk of ischemic stroke, the severity of ischemic stroke, and the incidence of cerebrovascular events in patients with new-onset AF.

Laparoscopic Ablation System for Complete Circumferential Renal Sympathetic Denervation.

GOAL: The catheter-based renal denervation (RDN) showed promising results for patients in lowering BP, but there were also many non-responders. One of the possible reasons was the incomplete neural ablation due to the ablation of renal nerves at random sites resulting in asymmetric innervation patterns along the renal artery. METHODS: We developed a laparoscopic ablation system that is optimized for complete RDN regardless of renal arterial innervation and size. To demonstrate its effectiveness, we evaluated the system using computational simulation and 28-day survival model using pigs. RESULTS: The ablations were focused around the tunica externa, and the ablation patterns could be predicted numerically during RDN treatment. In the animal study, the mean reduction of systolic BP and diastolic BP in the bilateral main renal arteries was 22.8 mmHg and 14.4 mmHg (P<0.001), respectively. The respond to immunostaining targeting tyrosine hydroxylase was significantly reduced at treatment site (108.2 ± 7.5 (control) vs. 63.4 ± 8.7 (treatment), P<0.001), and an increased degree of sympathetic signals interruption to kidneys was associated with the efficacy of RDN. CONCLUSION: The laparoscopic ablation system achieved complete circumferential RDN at the treatment site and could numerically predict the ablation patterns. SIGNIFICANCE: These findings clearly suggest that the proposed system can significantly improve the RDN effectiveness by reducing the variation to the percentage of injured nerves and open up a new opportunity to treat uncontrolled hypertension.

Lifestyle is associated with atrial fibrillation development in patients with type 2 diabetes mellitus.

We evaluated the impacts of lifestyle behaviors, namely smoking, alcohol consumption, and physical activity, on the development of new-onset AF in patients with DM. Using the Korean Nationwide database, we identified subjects diagnosed with type 2 DM and without previous history of AF between 2009 and 2012. Self-reported lifestyle behaviors were analyzed. Among 2,551,036 included subjects, AF was newly diagnosed in 73,988 patients (median follow-up 7.1 years). Both ex-smokers (hazard ratio [HR] 1.05, 95% confidence interval [CI] 1.02-1.07) and current smokers (HR 1.06, 95% CI 1.03-1.08) demonstrated a higher risk of AF than never smokers. Patients with moderate (15-29 g/day) (HR 1.12, 95% CI 1.09-1.15) and heavy (≥ 30 g/day) (HR 1.24, 95% CI 1.21-1.28) alcohol consumption exhibited an increased risk of AF, while subjects with mild alcohol consumption (< 15 g/day) (HR 1.01, 95% CI 0.99-1.03) had an AF risk similar to that of non-drinkers. Patients who engaged in moderate-to-vigorous physical activity showed a lower risk of AF (HR 0.93, 95% CI 0.91-0.94) than those who did not. This study suggests that smoking, alcohol consumption, and physical activity are associated with new-onset AF in patients with DM, and lifestyle management might reduce the risk of AF in this population.

Predictors of ischemic stroke for low-risk patients with atrial fibrillation: A matched case-control study.

BACKGROUND: The predictors of ischemic stroke in "low-risk" patients with atrial fibrillation (AF) (CHA2DS2-VASc score 0 in men or 1 in women) are debated. OBJECTIVE: This study aimed to investigate the factors associated with ischemic stroke in low-risk patients with AF. Imaging characteristics of their ischemic strokes were also evaluated. METHODS: This was a matched case-control study conducted at a single tertiary institution. We identified 44 patients with de novo ischemic stroke and incidentally found AF with a low-risk CHA2DS2-VASc score. A 1:5 age- and sex-matched control group was selected for patients with AF and a low-risk CHA2DS2-VASc score but without ischemic stroke and oral anticoagulant therapy. Conditional multivariate logistic regression analysis was performed to identify the predictors. RESULTS: There were no significant differences in age, sex, body mass index, comorbidities, left atrial size, and left ventricular ejection fraction. Smokers were more prevalent in the stroke group than in the nonstroke group (24 of 44 [54.5%] vs 22 of 220 [10.0%]; P < .001). Additionally, the mean white blood cell count was significantly higher in the stroke group (P = .019). In conditional univariate logistic regression analysis, smoking and white blood cell count were significant predictors of stroke. In multivariate analysis, smoking was the only significantly associated factor (matched odds ratio 9.10; 95% confidence interval 2.48-33.42). In the stroke group, 14 of 44 patients (31.8%) had multiple vascular territory infarcts. CONCLUSION: Smoking was the predictor associated with ischemic stroke in patients with AF and a low-risk CHA2DS2-VASc score.