Trends and disparities in cardiac implantable electronic device infection-related mortality in the United States.

INTRODUCTION: We performed a cross-sectional study using the Centers for Disease Control and Prevention's (CDC's) Wide-Ranging Online Data for Epidemiologic Research (WONDER) database to analyze the trends in cardiac implantable electronic device (CIED) infection-related mortality from 1999 to 2020. METHODS: We analyzed the death certificate data from the CDC WONDER database from 1999 to 2020 for CIED infections in the US population aged ≥25 years using International Classification of Diseases, Tenth Revision (ICD-10) codes, listed as the underlying or contributing cause of death. Age-adjusted mortality rates (AAMR) and 95% confidence intervals (CIs) were computed per 1 million population by standardizing crude mortality rates to the 2000 US census population. To assess annual mortality trends, we employed the Joinpoint regression model, calculating the annual percent change (APC) in AAMR and corresponding 95% CIs. RESULTS: Overall, there was an observed declining trend in AAMRs related to CIED infection-related mortality. Males accounted for 55% of the total deaths, with persistently higher AAMRs compared to females over the study duration. Both males and females had an overall decreasing trend in AAMRs throughout the study duration. On race/ethnicity stratified analysis, non-Hispanic (NH) Blacks exhibited the highest overall AAMR, followed by NH American Indians or Alaska Natives, NH Whites, Hispanic or Latinos, and NH Asian or Pacific Islanders. On a stratified analysis based on region, the South region had the highest overall AAMR, followed by the Midwest, West, and Northeast regions. CONCLUSION: Our study demonstrates a significant decline in CIED infection-related mortality in patients over the last two decades. Notable gender, racial/ethnic, and regional differences exist in the rates of mortality related to CIED infections.

Contemporary trends of leadless pacemaker implantation in the United States.

INTRODUCTION: Leadless pacemakers (LPM) have established themselves as the important therapeutic modality in management of selected patients with symptomatic bradycardia. To determine real-world utilization and in-hospital outcomes of LPM implantation since its approval by the Food and Drug Administration in 2016. METHODS: For this retrospective cohort study, data were extracted from the National Inpatient Sample database from the years 2016-2020. The outcomes analyzed in our study included implantation trends of LPM over study years, mortality, major complications (defined as pericardial effusion requiring intervention, any vascular complication, or acute kidney injury), length of stay, and cost of hospitalization. Implantation trends of LPM were assessed using linear regression. Using years 2016-2017 as a reference, adjusted outcomes of mortality, major complications, prolonged length of stay (defined as >6 days), and increased hospitalization cost (defined as median cost >34 098$) were analyzed for subsequent years using a multivariable logistic regression model. RESULTS: There was a gradual increased trend of LPM implantation over our study years (3230 devices in years 2016-2017 to 11 815 devices in year 2020, p for trend <.01). The adjusted mortality improved significantly after LPM implantation in subsequent years compared to the reference years 2016-2017 (aOR for the year 2018: 0.61, 95% CI: 0.51-0.73; aOR for the year 2019: 0.49, 95% CI: 0.41-0.59; and aOR for the year 2020: 0.52, 95% CI: 0.44-0.62). No differences in adjusted rates of major complications were demonstrated over the subsequent years. The adjusted cost of hospitalization was higher for the years 2019 (aOR: 1.33, 95% CI: 1.22-1.46) and 2020 (aOR: 1.69, 95% CI: 1.55-1.84). CONCLUSION: The contemporary US practice has shown significantly increased implantation rates of LPM since its approval with reduced rates of inpatient mortality.

Intensive Care Admissions and Outcome of Cardiac Arrests; A National Cohort Study From the United States.

OBJECTIVE: Outcomes of cardiac arrest among patients who had cardiopulmonary resuscitation (CPR) in intensive care units (ICU) has limited data on the national level basis in the United States. We aimed to study the outcomes of ICU CPRs. METHODS: Data from the national readmissions database (NRD) sample that constitutes 49.1% of the stratified sample of all hospitals in the United States were analyzed for ICU-related hospitalizations for the years 2016 to 2019. ICU CPR was defined by procedure codes. RESULTS: A total of 4,610,154 ICU encounters were reported for the years 2016 to 2019 in the NRD. Of these patients, 426,729 (9.26%) had CPR procedure recorded during the hospital encounter (mean age 65 ± 17.81; female 42.4%). And 167,597 (39.29%) patients had CPR on the day of admission, of which 63.16% died; while 64,752 (15.18%) patients had CPR on the day of ICU admission, of which 72.85% died. And 36,002 (8.44%) had CPR among patients with length of stay 2 days, of which 73.34% died. A total of 1,222,799 (26.5%) admitted to ICU died, and patients who had ICU CPR had higher mortality, 291,391(68.3%). Higher complication rates were observed among ICU CPR patients, especially who died. Over the years from 2016 to 2019, ICU CPR rates increased from 8.18% (2016) to 8.66% (2019); p-trend = 0.001. The mortality rates among patients admitted to ICU increased from 22.1% (2016) to 24.1% (2019); p-trend = 0.005. CONCLUSION: The majority of ICU CPRs were done on the first day of ICU admission. The trend for ICU CPR was increasing. The mortality trend for overall ICU admissions has increased, which is concerning and would suggest further research to improve the high mortality rates in the CPR group.

Same-day discharge for left atrial appendage occlusion procedure: A systematic review and meta-analysis.

INTRODUCTION: Most patients undergoing a left atrial appendage occlusion (LAAO) procedure are admitted for overnight observation. A same-day discharge strategy offers the opportunity to improve resource utilization without compromising patient safety. We compared the patient safety outcomes and post-discharge complications between same-day discharge versus hospital admission (HA) (>1 day) in patients undergoing LAAO procedure. METHODS: A systematic search of MEDLINE and Embase was conducted. Outcomes of interest included peri-procedural complications, re-admissions, discharge complications including major bleeding and vascular complications, ischemic stroke, all-cause mortality, and peri-device leak >5 mm. Mantel-Haenszel risk ratios (RRs) with 95% CIs were calculated. RESULTS: A total of seven observational studies met the inclusion criteria. There was no statistically significant difference between same-day discharge versus HA regarding readmission (RR: 0.61; 95% confidence interval [CI]: [0.29-1.31]; p = .21), ischemic stroke after discharge (RR: 1.16; 95% CI: [0.49-2.73]), peri-device leak >5 mm (RR: 1.27; 95% CI: [0.42-3.85], and all-cause mortality (RR: 0.60; 95% CI: [0.36-1.02]). The same-day discharge study group had significantly lower major bleeding or vascular complications (RR: 0.71; 95% CI: [0.54-0.94]). CONCLUSIONS: This meta-analysis of seven observational studies showed no significant difference in patient safety outcomes and post-discharge complications between same-day discharge versus HA. These findings provide a solid basis to perform a randomized control trial to eliminate any potential confounders.

The effect of weight loss on recurrence of atrial fibrillation after catheter ablation: A systematic review and meta-analysis.

BACKGROUND: Obesity is associated with an increased risk of developing recurrent atrial fibrillation (AF) after catheter ablation (CA). However, the current data on weight loss interventions show inconsistent results in preventing the recurrence of AF after CA. METHODS: We conducted a systematic search in MEDLINE and EMBASE to identify studies that reported the outcome of recurrence of AF after CA in obese patients undergoing weight interventions. The subgroup analysis included: (1) Weight loss versus no weight loss, (2) >10% weight loss versus <10% weight loss, (3) <10% weight loss versus no weight loss, (4) Follow-up <12 months, and (5) Follow-up >12 months after CA. Mantel-Haenszel risk ratios with a 95% confidence interval (CI) were calculated using a random effects model and for heterogeneity, I2 statistics were reported. RESULTS: A total of 10 studies (one randomized controlled trial and nine observational studies) comprising 1851 patients were included. The recurrence of AF was numerically reduced in the weight loss group (34.5%) versus no weight loss group (58.2%), but no statistically significant difference was observed (risk ratio [RR] = 0.76; 95% CI: 0.49-1.18, p = .22). However, there was a statistically significant reduction in recurrence of AF with weight loss versus no weight loss at follow-up >12 months after CA (RR = 0.47; 95% CI: 0.32-0.68, p < .0001). At follow-up >12 months after CA, both >10% weight loss versus <10% weight loss (RR = 0.49; 95% CI: 0.31-0.80, p = .004) and <10% weight loss versus no weight loss (RR = 0.39; 95% CI: 0.31-0.49, p < .00001) were associated with a statistically significant reduction in recurrent AF. CONCLUSION: In patients with AF undergoing CA, weight loss is associated with reducing recurrent AF at > 12 months after ablation and these benefits are consistently seen with both >10% and <10% weight loss. The benefits of weight loss in preventing recurrent AF after CA should be examined in larger studies with extended follow-up duration.

Left atrial appendage closure device outcomes among cirrhosis patients with atrial fibrillation: a United States National Cohort Study.

AIMS: Literature regarding outcomes associated with atrial fibrillation among cirrhosis patients who had left atrial appendage occlusion (LAAO) device procedure is limited. We aim to evaluate the in-hospital clinical outcomes and 30-day readmissions among LAAO with and without cirrhosis. METHODS AND RESULTS: We performed a retrospective study of all hospitalizations associated with the LAAO procedure, using the Nationwide Readmissions Database for the years 2016-19. Primary outcomes were in-hospital clinical outcomes and 30-day readmissions. A total of 54 897 index hospitalizations for LAAO (female 41.8%) were reported. Of these, 905(1.65%) had cirrhosis. Gastrointestinal (GI) bleeding was reported in 44 (4.9%) vs. 1606 (2.97%) and coagulopathy in 21 (2.3%) vs. 521 (0.96%) in cirrhosis and without-cirrhosis groups, respectively. A total of 872 (1.59%) patients needed blood transfusion, 24 (2.7%) vs. 848(1.57%) in cirrhosis vs. without-cirrhosis groups (P = 0.047). Fresh frozen plasma (FFP) transfusion was reported among 888 (1.62%), with cirrhosis 26 (3%) vs. without cirrhosis 862 (1.6%) (P = 0.05). On adjusted multivariate logistic regression analysis, acute kidney injury, coagulopathy, FFP transfusion, and blood transfusion were strongly associated with cirrhosis, and GI bleeding, ischaemic stroke, and intracranial haemorrhage were not associated with cirrhosis. Readmissions in 30 days were 5028 (9.18%), 167 (18.5%) in the cirrhosis group and 4861 (9%) without-cirrhosis group (P = 0.01). On multivariate Cox regression, CHA2DS2-Vasc score of six was significantly associated with 30-day readmission compared with other scores [hazard ratio 2.24; 95% confidence interval (1.58-3.16); P < 0.001]. CONCLUSION: Left atrial appendage occlusion procedure in patients with cirrhosis had relatively similar GI bleeding and stroke rates, however, had higher rates of 30-day readmission. A higher CHA2DS2-Vasc score was more likely to be associated with 30-day readmissions and hence would help in discharge planning. The long-term safety and efficacy of LAAO in the cirrhosis population need to be demonstrated.

Outcomes of percutaneous left atrial appendage occlusion device implantation in atrial fibrillation patients based on underlying stroke risk.

AIMS: To determine outcomes in atrial fibrillation patients undergoing percutaneous left atrial appendage occlusion (LAAO) based on the underlying stroke risk (defined by the CHA2DS2-VASc score). METHODS AND RESULTS: Data were extracted from the National Inpatient Sample for calendar years 2016-20. Left atrial appendage occlusion implantations were identified on the basis of the International Classification of Diseases, 10th Revision, Clinical Modification code of 02L73DK. The study sample was stratified on the basis of the CHA2DS2-VASc score into three groups (scores of 3, 4, and ≥5). The outcomes assessed in our study included complications and resource utilization. A total of 73 795 LAAO device implantations were studied. Approximately 63% of LAAO device implantations occurred in patients with CHA2DS2-VASc scores of 4 and ≥5. The crude prevalence of pericardial effusion requiring intervention was higher with increased CHA2DS2-VASc score (1.4% in patients with a score of ≥5 vs. 1.1% in patients with a score of 4 vs. 0.8% in patients with a score of 3, P < 0.01). In the multivariable model adjusted for potential confounders, CHA2DS2-VASc scores of 4 and ≥5 were found to be independently associated with overall complications [adjusted odds ratio (aOR) 1.26, 95% confidence interval (CI) 1.18-1.35, and aOR 1.88, 95% CI 1.73-2.04, respectively] and prolonged length of stay (aOR 1.18, 95% CI 1.11-1.25, and aOR 1.54, 95% CI 1.44-1.66, respectively). CONCLUSION: A higher CHA2DS2-VASc score was associated with an increased risk of peri-procedural complications and resource utilization after LAAO. These findings highlight the importance of patient selection for the LAAO procedure and need validation in future studies.

Association of atrial fibrillation and outcomes in patients undergoing bone marrow transplantation.

AIMS: Haematopoietic stem cell transplantation (HSCT) is a potentially curative therapy for several malignant and non-malignant haematologic conditions. Patients undergoing HSCT are at an increased risk of developing atrial fibrillation (AF). We hypothesized that a diagnosis of AF would be associated with poor outcomes in patients undergoing HSCT. METHODS AND RESULTS: The National Inpatient Sample (2016-19) was queried with ICD-10 codes to identify patients aged >50 years undergoing HSCT. Clinical outcomes were compared between patients with and without AF. A multivariable regression model adjusting for demographics and comorbidities was used to calculate the adjusted odds ratio (aOR) and regression coefficients with corresponding 95% confidence intervals and P-values. A total of 50 570 weighted hospitalizations for HSCT were identified, out of which 5820 (11.5%) had AF. Atrial fibrillation was found to be independently associated with higher inpatient mortality (aOR 2.75; 1.9-3.98; P < 0.001), cardiac arrest (aOR 2.86; 1.55-5.26; P = 0.001), acute kidney injury (aOR 1.89; 1.6-2.23; P < 0.001), acute heart failure exacerbation (aOR 5.01; 3.54-7.1; P < 0.001), cardiogenic shock (aOR 7.73; 3.17-18.8; P < 0.001), and acute respiratory failure (aOR 3.24; 2.56-4.1; P < 0.001) as well as higher mean length of stay (LOS) (+2.67; 1.79-3.55; P < 0.001) and cost of care (+67 529; 36 630-98 427; P < 0.001). CONCLUSION: Among patients undergoing HSCT, AF was independently associated with poor in-hospital outcomes, higher LOS, and cost of care.

In-hospital complications associated with pulmonary vein isolation with adjunctive lesions: the NCDR AFib Ablation Registry.

AIMS: No prior study has been adequately powered to evaluate real-world safety outcomes in those receiving adjunctive ablation lesions beyond pulmonary vein isolation (PVI). We sought to evaluate characteristics and in-hospital complications among patients undergoing PVI with and without adjunctive lesions. METHODS AND RESULTS: Patients in the National Cardiovascular Data Registry AFib Ablation Registry undergoing first-time atrial fibrillation (AF) ablation between 2016 and 2020 were identified and stratified into paroxysmal (PAF) and persistent AF, and separated into PVI only, PVI + cavotricuspid isthmus (CTI) ablation, and PVI + adjunctive (superior vena cava isolation, coronary sinus, vein of Marshall, atypical atrial flutter lines, other). Adjusted odds of adverse events were calculated using multivariable logistic regression. A total of 50 937 patients [PAF: 30 551 (60%), persistent AF: 20 386 (40%)] were included. Among those with PAF, there were no differences in the adjusted odds of complications between PVI + CTI or PVI + adjunctive when compared with PVI only. Among persistent AF, PVI + adjunctive was associated with a higher risk of any complication [3.0 vs. 4.5%, odds ratio (OR) 1.30, 95% confidence interval (CI) 1.07-1.58] and major complication (0.8 vs. 1.4%, OR 1.56, 95% CI 1.10-2.21), while no differences were observed in PVI + CTI compared with PVI only. Overall, there was high heterogeneity in adjunctive lesion type, and those receiving adjunctive lesions had a higher comorbidity burden. CONCLUSION: Additional CTI ablation was common without an increased risk of complications. Adjunctive lesions other than CTI are commonly performed in those with more comorbidities and were associated with an increased risk of complications in persistent AF, although the current analysis is limited by high heterogeneity in adjunctive lesion set type.

Safety and efficacy of colchicine for the prevention of post-operative atrial fibrillation in patients undergoing cardiac surgery: a meta-analysis of randomized controlled trials.

BACKGROUND AND AIMS: Colchicine is an anti-inflammatory drug that may prevent post-operative atrial fibrillation (POAF). The effect of this drug has been inconsistently shown in previous clinical trials. We aimed to compare the efficacy and safety of colchicine vs. placebo to prevent POAF in patients undergoing cardiac surgery. METHODS AND RESULTS: A systematic search of EMBASE, MEDLINE, SCOPUS, ClinicalTrials.gov, and the Cochrane Library for randomized controlled trials (RCTs) was conducted from inception till April 2023. The primary outcome was the incidence of POAF after any cardiac surgery. The secondary outcome was the rate of drug discontinuation due to adverse events and adverse gastrointestinal events. Risk ratios (RR) were reported using the Mantel Haenszel method. A total of eight RCTs comprising 1885 patients were included. There was a statistically significant lower risk of developing POAF with colchicine vs. placebo (RR: 0.70; 95% CI: 0.59-0.82; P < 0.01, I2 = 0%), and this effect persisted across different subgroups. There was a significantly higher risk of adverse gastrointestinal events (RR: 2.20; 95% CI: 1.38-3.51; P < 0.01, I2 = 55%) with no difference in the risk of drug discontinuation in patients receiving colchicine vs. placebo (RR: 1.33; 95% CI: 0.93-1.89; P = 0.11, I2 = 0%). CONCLUSION: This meta-analysis of eight RCTs shows that colchicine is effective at preventing POAF, with a significantly higher risk of adverse gastrointestinal events but no difference in the rate of drug discontinuation. Future studies are required to define the optimal duration and dose of colchicine for the prevention of POAF.

Psychosocial risk factors and outcomes in patients undergoing catheter ablation for atrial fibrillation.

The association of psychosocial risk factors with cardiovascular disease is well-established, and there is a growing recognition of their influence on atrial fibrillation (AF) . A recent National Heart, Lung, and Blood Institute workshop called for transforming AF research to integrate social determinants of health. There is limited data examining the impact of psychosocial risk factors (PSRFs) on outcomes in patients with an established diagnosis of AF. Catheter ablation for AF has been shown to improve arrhythmia burden and quality of life compared with medical treatment alone. It is unknown how PSRFs affect clinical outcomes in patients undergoing AF ablation. It is important to understand this relationship, especially given the increasing adoption of catheter ablation in clinical practice.

Efficacy and Safety of Catheter Ablation vs Antiarrhythmic Drugs as Initial Therapy for Management of Symptomatic Paroxysmal Atrial Fibrillation: A Meta-Analysis.

BACKGROUND: Catheter ablation is an effective treatment for atrial fibrillation (AF), primarily performed in patients who fail antiarrhythmic drugs. Whether early catheter ablation, as first-line therapy, is associated with improved clinical outcomes remains unclear. METHODS: Electronic databases (PubMed, Scopus, Embase) were searched until March 28th, 2021. Randomized controlled trials (RCTs) compared catheter ablation vs antiarrhythmic drug therapy as first-line therapy were included. The primary outcome of interest was the first documented recurrence of any atrial tachyarrhythmia (symptomatic or asymptomatic; AF, atrial flutter, and atrial tachycardia). Secondary outcomes included symptomatic atrial tachyarrhythmia (AF, atrial flutter, and atrial tachycardia) and serious adverse events. Unadjusted risk ratios (RR) were calculated from dichotomous data using Mantel Haenszel (M-H) random-effects with statistical significance considered if the confidence interval (CI) excludes one and p < 0.05. RESULTS: A total of six RCTs with 1212 patients (Ablation n = 609; Antiarrhythmic n = 603) were included. Follow- up period ranged from 1-2 years. Patients who underwent ablation were less likely to experience any recurrent atrial tachyarrhythmia when compared to patients receiving antiarrhythmic drugs (RR 0.63; 95% CI 0.55-0.73; p < 0.00001). Symptomatic atrial tachyarrhythmia was also lower in the ablation arm (RR 0.53; 95% CI 0.32-0.87; p = 0.01). No statistically significant differences were noted for overall any type of adverse events (RR 0.93; 95% CI 0.68-1.27; p = 0.64) and cardiovascular adverse events (RR 0.90; 95% CI 0.56-1.44; p = 0.65) respectively. CONCLUSIONS: Catheter ablation, as first-line therapy, was associated with a significantly lower rate of tachyarrhythmia recurrence compared to conventional antiarrhythmic drugs, with a similar adverse effect risk profile. These findings support a catheter ablation strategy as first-line therapy among patients with symptomatic paroxysmal atrial fibrillation.

Association of heart failure with procedural complications and in-hospital outcomes from left atrial appendage occlusion device implantation in patients with atrial fibrillation: insights from the national inpatient sample of 62 980 procedures.

AIMS: To determine outcomes in atrial fibrillation (AF) patients undergoing percutaneous left atrial appendage occlusion (LAAO) with concomitant heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF). METHODS AND RESULTS: Data were extracted from National Inpatient Sample for calendar years 2015-2019. LAAO device implantations were identified on the basis of ICD-10-CM code of 02L73DK. The outcomes assessed in our study included complications, in-patient mortality, and resource utilization. A total of 62 980 LAAO device implantations were studied. HFpEF (14.4%, n = 9040) and HFrEF (11.2%, n = 7100) were associated with a higher prevalence of major complications and in-patient mortality in crude analysis. In the multivariate model adjusted for potential confounders, HFpEF and HFrEF were not associated with major complications [adjusted odds ratio (aOR) 1.04, 95% confidence interval (CI) 0.93-1.16 and aOR 1.07, 95% CI 0.95-1.21] or in-patient mortality (aOR 1.48, 95% CI 0.85-2.55 and aOR 1.26, 95% CI 0.67-2.38). HFpEF and HFrEF were associated with prolonged length of stay (LOS) > 1 day (aOR 1.41, 95% CI 1.31-1.53 and aOR 1.66, 95% CI 1.53-1.80) and increased hospitalization costs > median cost 24 752$ (aOR 1.26, 95% CI 1.19-1.34 and aOR 1.21, 95% CI 1.13-1.29). CONCLUSION: The prevalence of HF in AF patients undergoing percutaneous LAAO was approximately 26%. HF was not independently associated with major complications and in-patient mortality but was associated with prolonged LOS and higher hospitalization costs.

Contemporary procedural trends of Watchman percutaneous left atrial appendage occlusion in the United States.

OBJECTIVE: To determine trends in real-world utilization and in-hospital adverse events from Watchman implantation since its approval by the Food and Drug Administration in 2015. BACKGROUND: The risk of embolic stroke caused by atrial fibrillation is reduced by oral anticoagulants, but not all patients can tolerate long-term anticoagulation. Left atrial appendage occlusion with the Watchman device has emerged as an alternative therapy. METHODS: This was a retrospective cohort study utilizing data from National Inpatient Sample for calendar years 2015-2017. The outcomes assessed in this study were associated complications, in-hospital mortality, and resource utilization trends after Watchman implantation. Trends analysis were performed using analysis of variance. Multivariable adjusted logistic regression analysis was performed to determine predictors of mortality. RESULTS: A total of 17 700 patients underwent Watchman implantation during the study period. There was a significantly increased trend in the number of Watchman procedures performed over the study years (from 1195 in 2015 to 11 165 devices in 2017, p < .01). A significant decline in the rate of complications (from 26.4% in 2015% to 7.9% in 2017, p < .01) and inpatient mortality (from 1.3% in 2015% to 0.1% in 2017, p < .01) were noted. Predictors of in-hospital mortality included a higher CHA2 DS2 -VASc score (odds ratio [OR]: 2.61 per 1-point increase, 95% confidence interval [CI]: 1.91-3.57), chronic blood loss anemia (OR: 3.63, 95% CI: 1.37-9.61) and coagulopathy (OR: 4.90, 95% CI: 2.32-10.35). CONCLUSION: In contemporary United States clinical practice, Watchman utilization has increased significantly since approval in 2015, while complications and in-patient mortality have declined.

Uninterrupted versus interrupted direct oral anticoagulation for catheter ablation of atrial fibrillation: A systematic review and meta-analysis.

INTRODUCTION: To evaluate the safety of uninterrupted versus interrupted direct oral anticoagulation (DOAC) for patients undergoing catheter ablation (CA) of atrial fibrillation (AF). METHODS: We conducted a systematic search of MEDLINE and EMBASE for randomized controlled trials (RCT) and observational studies comparing uninterrupted versus interrupted DOAC for patients undergoing CA of AF. Primary outcome was major bleeding. Secondary outcomes included minor bleeding, stroke or transient ischemic attack (TIA) or thromboembolism (TE), silent cerebral ischemic events, and cardiac tamponade. Meta-analysis was stratified by study design. Risk ratios (RR) with 95% confidence intervals were calculated using random effects model and Mantel-Haenszel method was used to pool RR. RESULTS: A total of 13 studies (7 randomized, 6 observational) comprising 3595 patients were included. The RCT restricted analysis did not show any difference in terms of major bleeding (risk ratio [RR] = 0.79; [0.35-1.79]), minor bleeding (RR = 0.99 [0.68-1.43]), stroke or TIA or TE (RR = 0.80 [0.19-3.32]), silent cerebral ischemic events (RR = 0.64 [0.32-1.28]), and cardiac tamponade (RR = 0.61 [0.20-1.92]). Observational study restricted analysis showed a protective effect of uninterrupted DOAC on silent cerebral ischemic events (RR = 0.45 [0.31-0.67]) and no difference in other outcomes. CONCLUSIONS: There is no difference in bleeding and thromboembolic outcomes with uninterrupted versus interrupted DOAC for CA of AF and observational data suggests that uninterrupted DOACs are protective against silent cerebral ischemic lesions.

In-hospital outcomes of transcatheter mitral valve repair in patients with and without end stage renal disease: A national propensity match study.

OBJECTIVES: To study trends of utilization, outcomes, and cost of care in patients undergoing undergoing transcatheter mitral valve repair (TMVr) with end-stage renal disease (ESRD). BACKGROUND: Renal disease has been known to be a predictor of poor outcome in patients with mitral valve disease. Outcome data for patients with ESRD undergoing TMVr remains limited. Therefore, our study aims to investigate trends of utilization, outcomes, and cost of care among patients with ESRD undergoing TMVr. METHODS: We analyzed NIS data from January 2010 to December 2017 using the ICD-9-CM codes ICD-10-CM to identify patients who underwent TMVr. Baseline characteristics were compared using a Pearson 𝜒2 test for categorical variables and independent samples t-test for continuous variables. Propensity matched analysis was done for adjusted analysis to compare outcomes between TMVr with and without ESRD. Markov chain Monte Carlo was used to account for missing values. RESULTS: A total of 15,260 patients (weighted sample) undergoing TMVr were identified between 2010 and 2017. Of these, 638 patients had ESRD compared to 14,631 patients who did not have ESRD. Adjusted in-hospital mortality was lower in non-ESRD group (3.9 vs. <1.8%). Similarly, ESRD patients were more likely to have non-home discharges (85.6 vs. 74.9%). ESRD patients also had a longer mean length of stay (7.9 vs. 13.5 days) and higher mean cost of stay ($306,300 vs. $271,503). CONCLUSION: ESRD is associated with higher mortality, complications, and resource utilization compared to non-ESRD patients. It is important to include this data in shared decision-making process and patient selection.

In-hospital outcomes of percutaneous mitral valve repair in patients with chronic obstructive pulmonary disease: insights from the national inpatient sample database.

OBJECTIVES: We aimed to assess the in-hospital outcomes in patients with mitral regurgitation treated with percutaneous mitral valve repair (PMVR) among patients with chronic obstructive pulmonary disease (COPD). BACKGROUND: There is lack of data on the outcomes of PMVR for mitral regurgitation in patients with COPD. METHODS: We analyzed the national inpatient sample (NIS) database from January 2012 to December 2016. RESULTS: A total of 9125 patients underwent PMVR in the period between January 2012 and December 2016, of whom 2,495 (27.3%) patients had concomitant COPD. Comparing COPD patients to non-COPD patients, COPD patients had higher proportion of females (48.3% vs. 46.6%, p = .16), were younger (75.8 ± 10.0 years vs. 76.4 ± 12.2 years; p = .04), had higher prevalence of peripheral vascular disease (17.4% vs. 13.5%; p < .01) and renal failure (39.3% vs. 37%; p < .01). After propensity matching, there was no significant difference in mortality among the COPD group versus non-COPD patients (2.6% vs. 2.9%; p = .6). Patients with COPD had higher proportion of in-hospital morbidities including St-segment elevation myocardial infarction (1.8% vs. 1.0%; p = .02), cardiogenic shock (1.4% vs. 0.4%; p < .01), vascular complications (2% vs. 0.8; p < .01), pneumothorax (1% vs. 0.4%; p < .01), and septic shock (1.2% vs. 0.4%; p < .01). Moreover, surrogates of severe disability (mechanical intubation and non-home discharges), cost of hospitalization, and length of stay were higher in the COPD group. CONCLUSIONS: There was no difference in mortality between the COPD and non-COPD patients after PMVR. Moreover, we observed higher rates of in-hospital morbidities, surrogates of severe disability, and higher resources utilization by the COPD group.

Sex-stratified analysis of the safety of percutaneous left atrial appendage occlusion.

OBJECTIVES AND BACKGROUND: There is insufficient current evidence about whether sex impacts outcomes of percutaneous left atrial appendage occlusion (LAAO). The aim of this study was to investigate the association between sex and short-term outcomes of LAAO. METHODS: Patients who were hospitalized and underwent LAAO from October 2015 to December 2017 in the National Readmission Database were queried. The primary endpoint of interest was major in-hospital adverse events. Secondary endpoints included, 30-day readmission rate, nonhome discharge, and cost of hospitalization. Propensity score matching (1:1) was performed to compare the outcomes among women and men. RESULTS: A total of 9,281 patients were included in the current analysis [women = 3,659 (39%); men = 5,622 (61%)]. Comparing women to men, women had lower prevalence of diabetes mellitus (30.6% vs 35.7%, p < .01), heart failure (28.6% vs 30.8%, p = .03), vascular disease (55.5% vs 69.6%, p < .01) and renal failure (18.3% vs 21.2%, p < .01), and higher CHA2 DS2 VASc score (5 [IQR4-6] vs 4 [IQR3-6], p < .01). After propensity-score matching, women had higher rate of major in-hospital adverse events (2.8% vs 1.9%; p < .01), and nonhome discharges (11.4% vs 6.7%; p < .01). Additionally, 30-day readmission rate was higher among women (10% vs 8.6%, p = .03). CONCLUSION: Among hospitalized patients undergoing LAAO, women carry higher risk for major in-hospital adverse events, nonhome discharge, and 30-day readmission rates.

Use and outcomes of cerebral embolic protection for transcatheter aortic valve replacement: A US nationwide study.

BACKGROUND: Outcomes data on the use of cerebral embolic protection devices (CPDs) with transcatheter aortic valve replacement (TAVR) remain limited. Previous randomized trials were underpowered for primary outcomes of stroke prevention and mortality. METHODS: The National Inpatient Sample and Nationwide Readmissions Database were queried from 2017 to 2018 to study utilization and inpatient mortality, neurological complications (ischemic stroke, hemorrhagic stroke, and transient ischemic attack), procedural complications, resource utilization, and 30-day readmissions with and without use of CPD. A 1:3 ratio propensity score matched model was created. RESULTS: Among 108,315 weighted encounters, CPD was used in 4380 patients (4.0%). Adjusted mortality was lower in patients undergoing TAVR with CPD (1.3% vs. 0.5%, p < 0.01). Neurological complications (2.5% vs. 1.7%, p < 0.01), hemorrhagic stroke (0.2% vs. 0%, p < 0.01) and ischemic stroke (2.2% vs. 1.4%, p < 0.01) were also lower in TAVR with CPD. Multiple logistic regression showed CPD use was associated with lower adjusted mortality (odds ratio (OR], 0.34 [95% confidence interval [CI], 0.22-0.52), p < 0.01) and lower adjusted neurological complications (OR, 0.68 (95% CI, 0.54-0.85], p < 0.01). On adjusted analysis, 30-day all-cause readmissions (Hazard ratio, HR 0.839, [95% CI, 0.773-0.911], p < 0.01) and stroke (HR, 0.727 [95% CI, 0.554-0.955), p = 0.02) were less likely in TAVR with CPD. CONCLUSION: We report real-world data on utilization and in-hospital outcomes of CPD use in TAVR. CPD use is associated with lower inpatient mortality, neurological, and clinical complications as compared to TAVR without CPD.

Representation of women, older patients, ethnic, and racial minorities in trials of atrial fibrillation.

BACKGROUND: Representation trends of women, older adults, and ethnic/racial minorities in randomized controlled trials (RCTs) of atrial fibrillation (AF) are uncertain. METHODS: We systematically reviewed 134 AF related RCTs (phase II and III) encompassing 149,162 participants using Medline and ClinicalTrials.gov through April 2019 to determine representation trends of women, older patients (≥75 years), and ethnic/racial minorities. Weighted data on the prevalence of AF from epidemiological studies were used to compare the representation of the studied groups of interest in AF RCTs to their expected burden of the disease. RESULTS: Only 18.7% of the RCTs reported proportion of older patients, and 12.7% RCTs reported ethnic/racial minorities. The proportions of women in RCTs versus general population were 35.2% and 35.1%, of Hispanics were 11.9% and 5.2%, of Blacks were 1.2% and 5.7%, of American Indian/Alaskans were 0.2% and 0.2%, of Asians were 14.2% and 2.4%, of native Hawaiian/Pacific Islanders were 0.05% and 0.1% and of non-Whites were 19.5% and 22.5%, respectively. The weighted mean age (SD) across the trials was 65.3 (3.2) years which was less than the corresponding weighted mean age of 71.1 (4.5) years in the comparative epidemiological data. CONCLUSION: The reporting of older patients and ethnic/racial minorities was poor in RCTs of AF. The representation of women and American Indian/Alaskan natives matched their expected population share of disease burden. Hispanics and Asians were over-represented and Blacks, native Hawaiian/Pacific Islanders and non-Whites were under-represented in RCTs of AF.