Incidence Of Composite Outcome Research Articles

Comparing the outcomes of rheumatic heart disease in pregnancy complicated with and without atrial fibrillation: A propensity score matched analysis

Atrial fibrillation (AF) may increase the risk of adverse maternal and fetal outcomes among pregnant with rheumatic valvular lesions (RHD). We aimed to assess the rate of occurrence of AF in pregnant with RHD and its impact on cardiac and maternal-fetal outcomes compared to those without it. The study group consisted of pregnant women with RHD and AF (cases) and a matched comparison group of pregnant women with RHD but without AF (controls) was derived from the database of pregnant women with RHD receiving care at our center between 2011 and 2021. Incidence of composite adverse outcomes(maternal death, heart failure, or thrombo-embolic events) and pregnancy outcomes were compared between them. Seventy-one (5.1%; 95%CI 4.1%-6.4%) pregnant women with RHD had AF during pregnancy and childbirth, most occurring in the late second or early third trimester. New-onset AF was diagnosed in 34 (47.9%) of them. After matching, the incidence of composite outcome was higher in women with AF (77.5% (95% CI 66.3%-85.7%) compared to women without AF (17.3%(95% CI 13.3% - 22.1%), p<0.001), with seven (9.9%) maternal deaths among cases and two (0.7%) in controls. Heart failure was the most common adverse cardiac event (26.7% vs. 4.2%, p<0.001, cases vs controls). Those with AF had higher odds (adjusted OR 56.6 (14.1 - 226.8)) of adverse cardiac outcomes after adjusting for other risk factors. The frequency of most non-cardiac pregnancy complications was similar in both groups. However, there was a trend towards a higher rate of miscarriage (16.9% vs. 9.9%), small-for-gestational-age babies(16.3 vs. 9.0%), and cesarean rates(31.9% vs. 18.3%) women with AF compared to those who did not experience AF. Atrial fibrillation in pregnancy among women with RHD was associated with an increased risk of maternal morbidity and mortality, with a trend towards an increase in some non-cardiac pregnancy complications compared to those pregnant women without AF. Our study results provide background data for developing and implementing a pregnancy-specific management strategy tailored to middle-income settings.

Comparative study of left vertebral artery revascularization in patients with and without aberrant left vertebral anatomy

ObjectiveLeft vertebral artery revascularization is indicated in surgery involving zone 2 of the aortic arch and is typically accomplished indirectly via subclavian artery revascularization. For aberrant left vertebral anatomy, direct revascularization is indicated. Our objective was to compare the outcomes of direct vertebral artery revascularization with indirect subclavian artery revascularization for treating aortic arch pathology and to identify predictors of mortality. MethodsA retrospective cohort study was conducted at a single tertiary hospital, including patients who underwent open or endovascular vertebral artery revascularization from 2005 to 2022. Those who underwent direct vertebral revascularization were compared with those who were indirectly revascularized via subclavian artery revascularization. The outcomes of interest were a composite outcome (any of death, stroke, nerve injury, and thrombosis) and mortality. Univariate logistic regression models were fitted to quantify the strength of differences between the direct and indirect revascularization cohorts. Cox regression was used to identify mortality predictors. ResultsOf 143 patients who underwent vertebral artery revascularization, 21 (14.7%) had a vertebral artery originating from the aortic arch. The median length of stay was 10 days (interquartile range, 6-20 days), and demographics were similar between cohorts. The incidence of composite outcome, bypass thrombosis, and hoarseness was significantly higher in the direct group (42.9% vs 18.0%, P = .019; 33.3% vs 0.8%, P < .0001; 57.1% vs 18.0%, P < .001, respectively). The direct group was approximately three times more likely to experience the composite outcome (odds ratio, 3.41; 95% confidence interval, 1.28, 9.08); similarly, this group was approximately six times more likely to have hoarseness (odds ratio, 5.88; 95% confidence interval, 2.21, 15.62). There was no significant difference in mortality rates at 30 days, 1, 3, 5, and 10 years of follow-up. Age, length of hospital stay, and congestive heart failure were identified as predictors of higher mortality. After adjusting for these covariates, the group itself was not an independent predictor of mortality. ConclusionsDirect vertebral revascularization was associated with higher rates of composite outcome (death, stroke, nerve injury, and thrombosis), bypass thrombosis and hoarseness. Patients with aberrant vertebral anatomy are at higher risks of these complications compared with patients with standard arch anatomy. However, after adjusting for other factors, mortality rates were not significantly different between the groups.

Systemic immune-inflammation index predicts the clinical outcomes in patients with acute uncomplicated type-B aortic dissection undergoing optimal medical therapy

BackgroundOptimal medical therapy (OMT) for uncomplicated type B aortic dissection (uTBAD) provides excellent short-term outcomes during follow up; however, its long-term therapeutic effectiveness is unsatisfactory. This study evaluated the predictive value of systemic immune-inflammation index (SII) for adverse events among patients with acute uTBAD undergoing OMT.MethodsWe performed a retrospective analysis of a prospectively maintained database between 2013 and 2020. The primary end point in this study was composite outcomes including aortic intervention, all-cause mortality, retrograde type A aortic dissection (rTAAD) and aortic diameter growth > 5 mm. The patients were divided into high and low SII groups according to the optimal cut-off value of SII as determined using the receiver operating characteristic curve. Cox proportional hazards models were constructed to estimate the hazards ratios and identify the predictors of composite outcomes.ResultsA total of 124 patients with acute uTBAD who underwent OMT were enrolled. One patient died during hospitalisation. At the end of a mean follow-up duration of 51 ± 23 months, 53 (43.1%) patients experienced composite outcomes, 15 patients (12.2%) died, 31 (25.2%) underwent aortic intervention, 21 (17.1%) exhibited diameter growth of > 5 mm, and 2 developed rTAAD. The patients were divided into low SII group (n = 78, 62.9%) and high SII group (n = 46, 37.1%) as per the optimal cut-off SII value of 1449. The incidence of composite outcomes in high SII group was significantly higher than that in low SII (28 [60.9%] vs. 26[33.3%], p < 0.01). Patients with high SII demonstrated significantly higher mortality rate than those with a low SII (11 [23.9%] vs. 5 [6.4%], respectively; p < 0.01). In addition, the high SII group had significantly higher rate of aortic-related reinterventions than the low SII group (16 [34.8%] vs. 15 [19.2%], p = 0.03). Multivariable Cox analyses showed that a high SII score was independently associated with composite outcomes rate (hazard ratio, 2.15; 95% confidence interval, 1.22–3.78; p < 0.01).ConclusionsThe long-term therapeutic effectiveness of OMT alone in patients with acute uTBAD is unsatisfactory. An SII > 1449 at the time of diagnosis is an independent predictor of OMT failure.

Higher plasma aldosterone is associated with increased risk of cardiovascular events in hypertensive patients with suspected OSA: UROSAH data

ObjectiveTo evaluate the association of plasma aldosterone concentration (PAC) with incident cardiovascular disease (CVD) and all-cause mortality in hypertensive patients with suspected obstructive sleep apnea (OSA) and calculate the optimal cut-off value of PAC for this specific population.Patients and methodsParticipants with PAC at baseline in UROSAH in 2011-2013 were enrolled and followed up till 2021. Composite outcome included CVD and all-cause mortality. Cox proportional hazards model was used to evaluate the relationship between PAC and the composite outcome. Time-dependent ROC curve was used to determine the optimal cut-off value of PAC. Besides, we conducted subgroup analyses and sensitivity analyses.Results3173 hypertensive participants aged 18-84 years comprised analytical sample. During a median follow-up of 7.3 years and 22640 person-years, 69 deaths and 343 cases of incident CVD occurred. The incidence of composite outcome was increased with elevation in tertile of PAC. Compared with the first tertile, the risk of CVD and all-cause death was higher in third tertile (HR=1.81, 95%CI: 1.39-2.35, P<0.001). Time-dependent ROC curve showed optimal threshold for PAC was 12.5ng/dl. Whether renin was suppressed or not (≤0.5 or >0.5ng/ml per h), elevated PAC was associated with an increased risk of CVD. Our results remained stable and consistent in sensitivity analyses.ConclusionHigher PAC was associated with increased risk of CVD and all-cause mortality in hypertensives with suspected OSA, even in the absence of primary aldosteronism (PA). Hypertensives with PAC≥12.5ng/dl showed a significantly increased risk of CVD, indicating that special attention and treatment were required in this specific population.

Lower bicarbonate level is associated with CKD progression and all-cause mortality: a propensity score matching analysis

BackgroundAlthough metabolic acidosis is known as a potential complication of chronic kidney disease (CKD), there is limited information concerning the association between metabolic acidosis and clinical outcomes.MethodsFive hundred fifty-two patients referred to renal division of Iwata City Hospital from 2015 to 2017 were included as a retrospective CKD cohort, and finally 178 patients with CKD stage III or IV and 20 to 80 years of age were analyzed. We examined the association between serum bicarbonate (HCO3−) levels and clinical outcomes using Kaplan-Meier methods after the matching of baseline characteristics by propensity scores.ResultsOf 178 patients with CKD, patients with lower HCO3− levels (N = 94), as compared with patients with higher HCO3− levels (N = 84), were more likely to be male (P < 0.05), had more severe CKD stages (P < 0.05), more frequent use of renin-angiotensin system inhibitor (P < 0.05) or uric acid lowering agent (P < 0.001), heavier body weight (P < 0.001) and lower estimated glomerular filtration rate (P < 0.05). In Kaplan-Meier analysis after propensity score matching, the incidence of composite outcome as the doubling of serum creatinine level from baseline, end-stage kidney disease requiring the initiation of dialysis, or death from any causes was significantly fewer in the higher HCO3− group than the lower HCO3− group (N = 57 each group, P = 0.016).ConclusionsLower HCO3− level is significantly associated with the doubling of serum creatinine level, end-stage kidney disease or all-cause mortality in patients with CKD.Trial registrationThis study was registered with the Clinical Trial Registry of the University Hospital Medical Information Network (http://www.umin.ac.jp/, study number: UMIN000044861).

Sugammadex Versus Neostigmine for Reversal of Residual Neuromuscular Blocks After Surgery: A Retrospective Cohort Analysis of Postoperative Side Effects.

Sugammadex and neostigmine given to reverse residual neuromuscular blockade can cause side effects including bradycardia, anaphylaxis, bronchospasm, and even cardiac arrest. We tested the hypothesis that sugammadex is noninferior to neostigmine on a composite of clinically meaningful side effects, or vice versa. We analyzed medical records of patients who had general, cardiothoracic, or pediatric surgery and were given neostigmine or sugammadex from June 2016 to December 2019. Our primary outcome was a collapsed composite of bradycardia, anaphylaxis, bronchospasm, and cardiac arrest occurring between administration of the reversal agent and departure from the operation room. We a priori restricted our analysis to side effects requiring pharmacologic treatment that were therefore presumably clinically meaningful. Sugammadex would be considered noninferior to neostigmine (or vice versa) if the odds ratio for composite of side effects did not exceed 1.2. Among 89,753 surgeries in 70,690 patients, 16,480 (18%) were given sugammadex and 73,273 (82%) were given neostigmine. The incidence of composite outcome was 3.4% in patients given sugammadex and 3.0% in patients given neostigmine. The most common individual side effect was bradycardia (2.4% in the sugammadex group versus 2.2% neostigmine). Noninferiority was not found, with an estimated odds ratio of 1.21 (sugammadex versus neostigmine; 95% confidence interval [CI], 1.09-1.34; noninferiority P = .57), and neostigmine was superior to sugammadex with an estimated odds ratio of 0.83 (0.74-0.92), 1-side superiority P < .001. The composite incidence was less with neostigmine than with sugammadex, but only by 0.4% (a negligible clinical effect). Since 250 patients would need to be given neostigmine rather than sugammadex to avoid 1 episode of a minor complication such as bradycardia or bronchospasm, we conclude that sugammadex and neostigmine are comparably safe.

Effect of preoperative cannabis use on perioperative outcomes: a retrospective cohort study

IntroductionThe reported use of cannabis within surgical population is increasing. Cannabis use is potentially associated with increased harms and varied effects on pain control. These have important implications to perioperative...

Association of cardiovascular health and incident atrial fibrillation in elderly population

ObjectiveTo evaluate whether baseline and changes in cardiovascular health (CVH) were related to incident atrial fibrillation (AF) risk in the elderly population.MethodsFrom the Korea National Health Insurance Service-Senior cohort, we...

P1656THE IMPACT OF PRE-TRANSPLANT DIALYSIS MODALITY ON EARLY POST-TRANSPLANT PERIOD ADVERSE EVENTS : A PROSPECTIVE COHORT STUDY WITH PROPENSITY SCORE MATCHING

Abstract Background and Aims Among peritoneal dialysis (PD) or hemodialysis (HD) while waiting for a kidney transplant (KT), which is better in terms of KT outcomes has long been of interest. Nowadays it is difficult to agree on which modality is better. The primary objective of this study was to compare the incidence of composite outcomes (delayed graft function, primary non-function, biopsy-proven acute rejection) within 1 year after primary adult KT between recipients taken PD and HD before KT (PD group vs. HD group, respectively). Method This study was a prospective, multi-sites cohort study. We used a propensity score matching to control for patients characteristics. Results Total 1040 patients were enrolled consecutively. Among them, 1030 patients (248, PD group; 782, HD group) were included in the final analysis. The HD group was older and had higher prevalence of diabetes, higher Charlson comorbidity index score, higher prevalence of positive PRA and more prescription of rituximab than the PD group significantly. After propensity score matching (246, PD group; 476, HD group), there were no differences in baseline characteristics between the two groups. In the whole population, there was no difference in the risk of the composite outcomes between the PD and HD groups (19% vs. 17%, hazard ratio [HR] 1.25, 95% confidence interval [CI] 0.88 ∼ 1.77, p = 0.21). There were also no differences in the risk of each component in the composite outcomes between the two groups. Primary non-function, a component of the composite outcomes did not occur in the both groups. There were no differences in the risks of death, frequency and total duration of re-hospitalization after KT for 1 year, and the changes of eGFR for 1 year between the two groups. The results from the propensity score matched population were consistent with those from the whole population. There was no difference in the risk of the composite outcomes between the PD and HD groups (19% vs. 17%, HR 1.17, 95% CI 0.80 ∼ 1.74, p = 0.43). Conclusion The pre-transplant dialysis modality does not affect the incidences of delayed graft function and acute rejection in early period of KT. (NCT01513707) This study was supported by Baxter Incorporated.

P6363Achieved blood pressure and cardiovascular outcomes in hypertensives

Abstract Background/Introduction Lowering blood pressure is very beneficial in reducing the risk of cardiovascular morbidity and mortality. But, the extent of optimal target blood pressure in hypertensive patients is still controversial. Purpose The objectives of this study were to assess the level of proper systolic and diastolic blood pressure to prevent cardiovascular events in older and younger patients. Methods We used the National Sample Cohort from the National Health Insurance Service of 2007 to 2013 in Korea and analyzed data from 44,462 hypertensive patients aged from 20 to 84, treated with one or more antihypertensive agents and participated at least one general health examination. Achieved systolic and diastolic blood pressure (SBP/DBP) were categorized by exclusive average achieved SBP (&lt;120, &lt;130, &lt;140, &lt;150, and ≥150 mmHg) and DBP (&lt;70, &lt;80, &lt;90, &lt;100, and ≥100 mmHg) categories using the blood pressure measurements of one or more available health examinations. The primary outcome was defined as composite, which was the first occurred event among admissions of myocardial infarction, stroke, and heart failure or cardiovascular death. Secondary outcomes were individual components of composite outcome and all-cause death. Results Of 44,462 patients, 5,478 (12.3%), 13,410 (30.2%), 15,021 (33.8%), 7,051 (15.9%), and 3,502 (7.9%) patients achieved SBP &lt;120 mm Hg, 120–129 mm Hg, 130–139 mm Hg, 140–149 mm Hg, and ≥150 mm Hg, respectively. During the median follow-up of 6.8 years, 2,151 (4.8%) died by all-cause of death, and 2,463 (5.5%) met the criteria of composite outcome. In elderly patients, compared with achieved SBP 120–129 (reference), there was no significant increase in risk at SBP 130–139 mm Hg and 140–149 mm Hg, but SBP 150 mm Hg or more was positively associated with significant risk of composite outcome and all-cause death, with HR of 1.29 (95% CI, 1.11–1.51) and 1.66 (95% CI, 1.43–1.92), respectively (Figure). On the other hand, in younger patients, the risk for incidence of composite outcome was significantly increased both at SBP 140–149 mm Hg (HR, 1.39; 95% CI, 1.11–1.73) and 150 mm Hg or more (HR, 2.00; 95% CI, 1.53–2.62) In addition, an achieved SBP 130 mm Hg and more was also significantly associated with all-cause death with HR of 1.27 (95% CI, 1.00–1.62). Compared with 120–129 mm Hg, elderly patients who had achieved SBP less than 120 mm Hg were more likely to have increased risk for composite outcome (HR, 1.29; 95% CI, 1.10–1.52), but not in younger patients (HR, 1.01; 95% CI, 0.78–1.30). Conclusion In conclusion, an intensive lowering of blood pressure is more likely to increase the risk rather than to prevent major cardiovascular events and all-cause death, particularly in older than younger. Therefore, an intensive blood pressure lowering of SBP/DBP below 120/70 mm Hg in the elderly should be avoided. Acknowledgement/Funding The Korea National Institute of Health research grant 2017-NI63001-00

Statins for primary prevention in adults aged 75 years and older: A nationwide population-based case-control study

Background and aimsThere is inadequate evidence to establish statin treatment for primary prevention in the elderly. This study evaluated whether statins are beneficial for primary prevention of cardiovascular disease (CVD) and all-cause death in adults aged ≥ 75 years. MethodsA nationwide, nested case-control study was conducted in Korea. Individuals who developed CVD, including myocardial infarction (MI), stroke, or death from all causes, were matched to controls based on duration of follow-up, age, and sex at the index date. The statin administration data from both groups were retrospectively collected from the index date to five years before. Odds ratios (ORs) and 95% confidence intervals (CIs) for composite and individual outcomes associated with statin treatment were estimated by conditional logistic regression analyses. ResultsIn total, 11,017 cases were matched to 55,085 control subjects. Current use of statins was significantly associated with a reduced risk of composite outcome (adjusted OR [AOR] 0.77; 95% CI 0.71–0.84), compared with non-users. Current use of statin also reduced the risk of stroke (AOR 0.74; 95% CI 0.61–0.89) and of all-cause death (AOR 0.73; 95% CI 0.66–0.81), but not of MI. However, former use of statins had no effect on CVD or all-cause death. There were significant decreasing trends in the incidence of composite outcomes and individual stroke or all-cause death with longer duration of statin treatment. ConclusionsCurrent statin treatment has a beneficial effect as primary prevention for composite outcomes and individual event of stroke or all-cause death in Koreans aged ≥75 years.

O12-7 - Low Iron at Discharge Related to Adverse Outcomes in Acute Decompensated Heart Failure (ADHF) Patients

Background: Iron deficiency is associated with poor outcome in chronic HF, but the clinical significance of iron in ADHF is poorly understood. We examined the impact of iron in ADHF patients. Methods: We analyzed iron level at discharge in 231 ADHF patients. Patients were divided into 2 groups according to the median iron level. The endpoint was set as the composite outcome, which included all-cause mortality and readmission for HF. Results: During a mean follow-up of 18.9 months, Kaplan-Meier analysis showed that the incidence of composite outcome was significantly higher in the low iron group (log-rank P = .0006). The low iron was an independent predictor of composite outcome (HR, 1.50; 95%CI, 1.01–2.25; P = .0428). Conclusions: Low iron at discharge was associated with an increased risk of adverse outcomes in ADHF patients.

Effectiveness of a Multimodal Community Intervention Program to Prevent Suicide and Suicide Attempts: A Quasi-Experimental Study

BackgroundMultilevel and multimodal interventions have been suggested for suicide prevention. However, few studies have reported the outcomes of such interventions for suicidal behaviours.MethodsWe examined the effectiveness of a community-based multimodal intervention for suicide prevention in rural areas with high suicide rates, compared with a parallel prevention-as-usual control group, covering a total of 631,133 persons. The effectiveness was also examined in highly populated areas near metropolitan cities (1,319,972 persons). The intervention started in July 2006, and continued for 3.5 years. The primary outcome was the incidence of composite outcome, consisting of completed suicides and suicide attempts requiring admission to an emergency ward for critical care. We compared the rate ratios (RRs) of the outcomes adjusted by sex, age group, region, period and interaction terms. Analyses were performed on an intention-to-treat basis and stratified by sex and age groups.FindingsIn the rural areas, the overall median adherence of the intervention was significantly higher. The RR of the composite outcome in the intervention group decreased 7% compared with that of the control group. Subgroup analyses demonstrated heterogeneous effects among subpopulations: the RR of the composite outcome in the intervention group was significantly lower in males (RR = 0.77, 95% CI 0.59–0.998, p = 0.0485) and the RR of suicide attempts was significantly lower in males (RR = 0.39, 95% CI 0.22–0.68, p = 0.001) and the elderly (RR = 0.35, 95% CI 0.17–0.71, p = 0.004). The intervention had no effect on the RR of the composite outcome in the highly populated areas.InterpretationOur findings suggest that this community-based multimodal intervention for suicide prevention could be implemented in rural areas, but not in highly populated areas. The effectiveness of the intervention was shown for males and for the elderly in rural areas.Trial RegistrationClinicalTrials.gov NCT00737165 UMIN Clinical Trials Registry UMIN000000460

The effects of cyclophosphamide and mycophenolate on end-stage renal disease and death of lupus nephritis

Debate continues about the optimal treatment modality of lupus nephritis (LN). We compared the efficacy and safety of intravenous cyclophosphamide (CYC) and mycophenolate mofetil (MMF) for LN treatment in Korea. After searching for systemic lupus erythematosus (SLE) patients diagnosed between 1998 and 2007 with the diagnostic code of ICD10, we selected the 71 patients who were treated with CYC or MMF without any other immunosuppressant except systemic steroid. Composite outcome was defined as progression to end-stage renal disease (ESRD) and/or all-cause mortality. The initial manifestations of the CYC group were more severe than those of the MMF group. The mean daily MMF dose was 980 ± 100 mg for 21.67 ± 18.25 months. The mean monthly dose per CYC pulse therapy was 850 ± 30 mg for 17.04 ± 13.15 months. The incidence of composite outcome was 5/20 (25%) in the MMF group and 4/51 (7.8%) in the CYC group. The relative risk (RR) for composite outcome in the CYC group was 0.249 (95% CI for RR: 0.067-0.934, p = 0.039) compared with the MMF group with Cox's hazard proportional analysis. In Kaplan-Meier analysis, the probability of composite outcome was lower in the CYC group than in the MMF group (Log rank test p-value = 0.026). The results of this retrospective study suggest that intravenous CYC therapy may be more efficacious in averting ESRD and death than MMF. These results need to be confirmed in a larger randomized controlled trial.