Cardiogenic shock complicating acute myocardial infarction and multivessel disease: revascularization strategy according to ischemic territory.

INTRODUCTION AND OBJECTIVES: The association of revascularization strategy with clinical outcomes according to the ischemic territory of nonculprit lesion has not been documented in patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS). This study aimed to compare outcomes between culprit-only and immediate multivessel percutaneous coronary intervention (PCI) according to ischemic territory in patients with AMI-CS. METHODS: A total of 536 patients with AMI-CS and multivessel disease from the SMART-RESCUE registry were categorized according to ischemic territory (nonculprit left main/proximal left anterior descending artery [LM/pLAD] vs culprit LM/pLAD vs no LM/pLAD). The primary outcome was a patient-oriented composite endpoint (POCE) consisting of all-cause death, myocardial infarction, rehospitalization due to heart failure, or repeat revascularization at 1 year. RESULTS: Among the total population, 108 patients had nonculprit LM/pLAD, 228 patients had culprit LM/pLAD, and 200 patients had no LM/pLAD, with the risk of POCE being higher in patients with large ischemic territory lesions (53.6% vs 53.4% vs 39.6%; P = .02). Multivessel PCI was associated with a significantly lower risk of POCE compared with culprit-only PCI in patients with nonculprit LM/pLAD (40.7% vs 66.9%; HR, 0.52; 95%CI, 0.29-0.91; P=.02), but not in those with culprit LM/pLAD (P=.46) or no LM/pLAD (P=.47). A significant interaction existed between revascularization strategy and large nonculprit ischemic territory (P=.03). CONCLUSIONS: Large ischemic territory involvement was associated with worse clinical outcomes in patients with AMI-CS and multivessel disease. Immediate multivessel PCI might improve clinical outcomes in patients with a large nonculprit ischemic burden.

Seasonal variation and prognosis in patients with acute myocardial infarction complicated by cardiogenic shock.

Background: Little is known about the association between seasonal variation and prognosis in patients with CS caused by AMI. Objectives: We investigated the 12-month clinical outcomes in patients treated with percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) according to season. Methods: A total of 695 patients undergoing PCI for AMI complicated by CS was enrolled from 12 centers in South Korea. The study patients were divided into four groups according to season in which the AMI with CS occurred (spring, n = 178 vs. summer, n = 155 vs. autumn, n = 182 vs. winter, n = 180). We compared major adverse cardiovascular events (MACEs; the composite of cardiac death, myocardial infarction, re-hospitalization due to heart failure, and any revascularization) between the four groups. Results: The risk of MACE during the 12 months after CS was similar in the four groups: spring, 68 patients, vs. summer, 69, vs. autumn, 73, vs. winter, 68 (p = 0.587). Multivariate Cox-regression analysis revealed no significant difference in 12-month MACE among groups compared to the spring group after inverse probability of treatment weighting adjustment (summer, HR 1.40, 95 % CI 0.98-1.99, p = 0.062; autumn, HR 1.26, 95 % CI 0.89-1.80, p = 0.193; winter, HR 1.18, 95 % CI 0.83-1.67, p = 0.356). The similarity of MACE between the four groups was consistent across a variety of subgroups. Conclusions: After adjusting for baseline differences, seasonal variation seems not to influence the mid-term risk of 12-month MACE in patients treated with PCI for AMI complicated by CS. Condensed abstract: Data are limited regarding the association between seasonal variation and prognosis in patients with cardiogenic shock (CS) caused by AMI. This study divided patients undergoing PCI for AMI complicated by CS into four groups based on the season of occurrence and found no significant differences in 12-month MACE between the groups after adjusting for bias and confounding factors. Multivariate analysis revealed consistent MACE similarity across subgroups. The study suggests that seasonal variation has no impact on the mid-term risk of 12-month MACE in patients with CS caused by AMI, after adjusting for baseline differences. Trial registration: ClinicalTrials.gov NCT02985008RESCUE (REtrospective and prospective observational Study to investigate Clinical oUtcomes and Efficacy of left ventricular assist device for Korean patients with cardiogenic shock), NCT02985008, Registered December 5, 2016 - retrospectively and prospectively. Irb information: This study was approved by the institutional review board of Samsung Medical Center (Reference number: 2016-03-130).

Clinical Significance of Residual Ischemia in Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing VA-ECMO.

BACKGROUND: Although culprit-only revascularization during the index procedure has been recommended in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS), the reduction of residual ischemia is also emphasized to improve clinical outcomes. However, few data are available about the significance of residual ischemia in patients undergoing mechanical circulatory supports. This study aimed to evaluate the effects of residual ischemia on clinical outcomes in AMI patients undergoing venoarterial-extracorporeal membrane oxygenation (VA-ECMO). METHODS: AMI patients with multivessel disease who underwent VA-ECMO due to refractory CS were pooled from the RESCUE and SMC-ECMO registries. The included patients were classified into three groups according to residual ischemia evaluated using the residual SYNTAX score (rSS): rSS = 0, 0 < rSS ≤ 8, and rSS > 8. The primary outcome was 1-year all-cause death. RESULTS: A total of 408 patients were classified into the rSS = 0 (N = 100, 24.5%), 0 < rSS ≤ 8 (N = 136, 33.3%), and rSS > 8 (N = 172, 42.2%) groups. The cumulative incidence of the primary outcome differed significantly according to rSS (33.9% vs. 55.4% vs. 66.1% for rSS = 0, 0 < rSS ≤ 8, and rSS > 8, respectively, overall P < 0.001). In a multivariable model, rSS was independently associated with the risk of 1-year all-cause death (HRadj 1.03, 95% CI 1.01-1.05, P = 0.003). Conversely, the baseline SYNTAX score was not associated with the risk of the primary outcome. Furthermore, when patients were stratified by rSS, the primary outcome did not differ significantly between the high and low delta SYNTAX score groups. CONCLUSIONS: In AMI patients with refractory CS who underwent VA-ECMO, residual ischemia was associated with an increased risk of 1-year mortality. Future studies are needed to evaluate the efficacy and safety of revascularization strategies to minimize residual ischemia in patients with CS supported with VA ECMO. CLINICAL TRIAL REGISTRATION: REtrospective and Prospective Observational Study to Investigate Clinical oUtcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock (RESCUE), NCT02985008.

Efficacy and safety of durable versus biodegradable polymer drug-eluting stents in patients with acute myocardial infarction complicated by cardiogenic shock.

The clinical impact of different polymer technologies in newer-generation drug-eluting stents (DESs) for patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains poorly understood. We investigated the efficacy and safety of durable polymer DESs (DP-DESs) compared with biodegradable polymer DESs (BP-DESs). A total of 620 patients who underwent percutaneous coronary intervention with newer-generation DESs for AMI complicated by CS was divided into two groups based on polymer technology: the DP-DES group (n = 374) and the BP-DES group (n = 246). The primary outcome was target vessel failure (TVF) during a 12-month follow-up, defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization. Both the DP-DES and BP-DES groups exhibited low stent thrombosis rates (1.3% vs. 1.6%, p = 0.660). The risk of TVF did not significantly differ between the two groups (34.2% vs. 28.5%, hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.69-1.29, p = 0.721). This finding remained consistent after adjustment with inverse probability of treatment weighting (28.1% vs. 25.1%, HR 0.98, 95% CI 0.77-1.27, p = 0.899). In AMI patients complicated by CS, the risk of a composite of cardiac death, myocardial infarction, or target vessel revascularization was not significantly different between those treated with DP-DESs and those treated with BP-DESs.Trial registration: RESCUE registry, https://clinicaltrials.gov/ct2/show/NCT02985008 , NCT02985008.

Prediction of In-Hospital Mortality for Ischemic Cardiogenic Shock Requiring Venoarterial Extracorporeal Membrane Oxygenation.

BACKGROUND: Clinical outcome of ischemic cardiogenic shock (CS) requiring extracorporeal membrane oxygenation is highly variable, necessitating appropriate assessment of prognosis. However, a systemic predictive model estimating the mortality of refractory ischemic CS is lacking. The PRECISE (Prediction of In-Hospital Mortality for Patients With Refractory Ischemic Cardiogenic Shock Requiring Veno-Arterial Extracorporeal Membrane Oxygenation Support) score was developed to predict the prognosis of refractory ischemic CS due to acute myocardial infarction. METHODS AND RESULTS: Data were obtained from the multicenter CS registry RESCUE (Retrospective and Prospective Observational Study to Investigate Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock) that consists of 322 patients with acute myocardial infarction complicated by refractory ischemic CS requiring extracorporeal membrane oxygenation support. Fifteen parameters were selected to assess in-hospital mortality. The developed model was validated internally and externally using an independent external cohort (n=138). Among 322 patients, 138 (42.9%) survived postdischarge. Fifteen predictors were included for model development: age, diastolic blood pressure, hypertension, chronic kidney disease, peak lactic acid, serum creatinine, lowest left ventricular ejection fraction, vasoactive inotropic score, shock to extracorporeal membrane oxygenation insertion time, extracorporeal cardiopulmonary resuscitation, use of intra-aortic balloon pump, continuous renal replacement therapy, mechanical ventilator, successful coronary revascularization, and staged percutaneous coronary intervention. The PRECISE score yielded a high area under the receiver-operating characteristic curve (0.894 [95% CI, 0.860-0.927]). External validation and calibration resulted in competent sensitivity (area under the receiver-operating characteristic curve, 0.895 [95% CI, 0.853-0.930]). CONCLUSIONS: The PRECISE score demonstrated high predictive performance and directly translates into the expected in-hospital mortality rate. The PRECISE score may be used to support clinical decision-making in ischemic CS (www.theprecisescore.com). REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02985008.

Prognostic effect of sex according to shock severity in patients with acute myocardial infarction complicated by cardiogenic shock.

BACKGROUND: Sex disparities in cardiogenic shock (CS) treatment are controversial, and the prognostic implications of sex remain unclear in CS caused by acute myocardial infarction (AMI). OBJECTIVES: This study aimed to evaluate the prognostic effect of sex according to the severity of CS in patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by CS. METHODS: We assessed 695 patients from 12 tertiary centers in South Korea who underwent PCI for AMI complicated by CS, and analyzed outcomes by sex (female [n = 184] vs. male [n = 511]). We compared a 12-month patient-oriented composite endpoint (POCE, defined as a composite of all-cause mortality, myocardial infarction, re-hospitalization due to heart failure, and repeat revascularization) between the sexes, respective of SCAI shock stage C&D or E. Propensity score-matched analysis was performed to reduce bias. RESULTS: We found that the female group was older and had higher vasoactive-inotropic and IABP-SHOCK II scores than the male group, with findings consistent across SCAI shock stages. During the 12-month follow-up period, multivariate analysis revealed no significant differences in POCE (HR 1.01, 95% CI 0.67-1.53, p = 0.963 for SCAI stage C&D, HR 1.24, 95% CI 0.84-1.84, p = 0.286 for SCAI stage E) between females and males. After propensity score matching, the incidence of POCE (HR 1.47, 95% CI 0.79-2.72, p = 0.220 for SCAI stage C&D, HR 0.88, 95% CI 0.49-1.57, p = 0.665 for SCAI stage E) was similar between sexes. CONCLUSIONS: Sex does not appear to influence the risk of 12-month POCE in patients treated with PCI for CS caused by AMI, irrespective of shock severity. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT02985008. RESCUE (REtrospective and prospective observational Study to investigate Clinical oUtcomes and Efficacy of left ventricular assist device for Korean patients with cardiogenic shock), NCT02985008, Registered December 5, 2016 - retrospectively and prospectively. IRB INFORMATION: This study was approved by the institutional review board of Samsung Medical Center (Reference number: 2016-03-130).

Predictors of in-hospital mortality after successful weaning of venoarterial extracorporeal membrane oxygenation in cardiogenic shock.

Limited knowledge exists regarding the predictors of mortality after successful weaning of venoarterial extracorporeal membrane oxygenation (ECMO). We aimed to identify predictors of in-hospital mortality in patients with cardiogenic shock (CS) after successful weaning from ECMO. Data were obtained from a multicenter registry of CS. Successful ECMO weaning was defined as survival with minimal mean arterial pressure (> 65 mmHg) for > 24 h after ECMO removal. The primary outcome was in-hospital mortality after successful ECMO weaning. Among 1247 patients with CS, 485 received ECMO, and 262 were successfully weaned from ECMO. In-hospital mortality occurred in 48 patients (18.3%). Survivors at discharge differed significantly from non-survivors in age, cardiovascular comorbidities, cause of CS, left ventricular ejection fraction, and use of adjunctive therapy. Five independent predictors for in-hospital mortality were identified: use of continuous renal replacement therapy (odds ratio 5.429, 95% confidence interval [CI] 2.468-11.940; p < 0.001), use of intra-aortic balloon pump (3.204, 1.105-9.287; p = 0.032), diabetes mellitus (3.152, 1.414-7.023; p = 0.005), age (1.050, 1.016-1.084; p = 0.003), and left ventricular ejection fraction after ECMO insertion (0.957, 0.927-0.987; p = 0.006). Even after successful weaning of ECMO, patients with irreversible risk factors should be recognized, and careful monitoring should be done for sign of deconditioning.

Impact of Acute Myocardial Infarction Type on Prognosis in Female Patients With Cardiogenic Shock.

There are limited data about mid-term prognosis according to acute myocardial infarction (AMI) type in female patients with AMI complicated by cardiogenic shock (CS). In this study, we evaluated the impact of AMI type on prognosis in female patients who underwent percutaneous coronary intervention (PCI) for AMI complicated by CS. A total of 184 female patients who underwent PCI for AMI complicated by CS were enrolled from 12 centers in the Republic of Korea. Patients were divided into 2 groups according to AMI type: the ST-segment elevation myocardial infarction (n = 114) and the non-ST-segment elevation myocardial infarction (n = 70) group. Primary outcome was a major adverse cardiac event (MACE) (defined as a composite of cardiac death, myocardial infarction, or repeat revascularization). Propensity-score matching analysis was performed to reduce selection bias and potential confounding factors. During 12-month follow-up, a total of 73 MACEs occurred (ST-segment elevation myocardial infarction group, 47 [41.2%] vs non-ST-segment elevation myocardial infarction group, 26 [37.1%], p = 0.643). Multivariate analysis revealed no significant difference in the incidence of MACE at 12 months between the 2 groups (adjusted hazard ratio 1.16, 95% confidence interval 0.70 to 2.37, p = 0.646). After propensity-score matching, the incidence of MACE at 12 months remained similar between the 2 groups (hazard ratio 1.31, 95% confidence interval 0.69 to 2.52, p = 0.413). The similarity in MACEs between the 2 groups was consistent across a variety of subgroups. In conclusion, after adjusting for baseline differences, AMI clinical type did not appear to increase the risk of MACEs at 12 months in female patients who underwent emergency PCI for AMI complicated by CS.

Culprit-Only Versus Immediate Multivessel Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicating Advanced Cardiogenic Shock Requiring Venoarterial-Extracorporeal Membrane Oxygenation.

Background Despite the benefit of culprit-only percutaneous coronary intervention (PCI) in the CULPRIT-SHOCK (Culprit Lesion Only PCI Versus Multi-vessel PCI in Cardiogenic Shock) trial, the optimal revascularization strategy for refractory cardiogenic shock (CS) requiring mechanical circulatory support devices remains controversial. This study aimed to compare clinical outcomes between the culprit-only and immediate multivessel PCI strategies in patients with acute myocardial infarction complicated by CS who underwent venoarterial-extracorporeal membrane oxygenation before revascularization. Methods and Results This study included patient-pooled data from the RESCUE (Retrospective and Prospective Observational Study to Investigate Clinical Outcomes and Efficacy of Left Ventricular Assist Devices for Korean Patients With Cardiogenic Shock) and SMC-ECMO (Samsung Medical Center-Extracorporeal Membrane Oxygenation) registries. A total of 315 patients with acute myocardial infarction with multivessel disease who underwent venoarterial-extracorporeal membrane oxygenation before revascularization attributable to refractory CS were included in this analysis. The study population was classified into culprit-only versus immediate multivessel PCI according to nonculprit lesion treatment strategies. The primary end point was 30-day mortality or renal-replacement therapy, and the key secondary end point was 12-month follow-up mortality. Among the study population, 175 (55.6%) underwent culprit-only PCI and 140 (44.4%) underwent immediate multivessel PCI. Compared with culprit-only PCI, immediate multivessel PCI was associated with significantly lower risks of 30-day mortality or renal-replacement therapy (68.0% versus 54.3%; P=0.018) and all-cause mortality during 12 months of follow-up (59.5% versus 47.5%; hazard ratio [HR], 0.689 [95% CI, 0.506-0.939]; P=0.018) in patients with acute myocardial infarction and CS who underwent venoarterial-extracorporeal membrane oxygenation before revascularization. These results were also consistent in the 99 pairs of propensity score-matched population (60.6% versus 43.6%; HR, 0.622 [95% CI, 0.420-0.922]; P=0.018). Conclusions Among patients with acute myocardial infarction with multivessel disease complicated by advanced CS requiring venoarterial-extracorporeal membrane oxygenation before revascularization, immediate multivessel PCI was associated with lower incidences of 30-day mortality or renal replacement therapy and 12-month follow-up mortality, compared with culprit-only PCI. Registration Information clinicaltrials.gov. Identifier: NCT02985008.

Non-culprit left main coronary artery disease in acute myocardial infarction complicated by cardiogenic shock.

OBJECTIVES: We evaluated the clinical impact of residual non-culprit left main coronary artery disease (LMCAD) on prognosis in patients undergoing emergent percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) complicated by cardiogenic shock (CS). METHODS: A total of 429 patients who underwent PCI for AMI complicated by CS was enrolled from 12 centers in the Republic of Korea. The patients were divided into two groups according to presence of non-culprit LMCAD or not: the LMCAD non-culprit group (n = 43) and the no LMCAD group (n = 386). Primary outcome was major adverse cardiac event (MACE, defined as a composite of cardiac death, myocardial infarction, or repeat revascularization). Propensity score matching analysis was performed to reduce selection bias and potential confounding factors. RESULTS: During a 12-month follow-up, a total of 168 MACEs occurred (LMCAD non-culprit group, 17 [39.5%] vs. no LMCAD group, 151 [39.1%]). Multivariate analysis revealed no significant difference in the incidence of MACE at 12 months between the LMCAD non-culprit and no LMCAD groups (adjusted hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.58 to 1.62, p = 0.901). After propensity score matching, the incidence of MACE was still similar between the two groups (HR 0.64; 95% CI 0.33 to 1.23; p = 0.180). The similarity of MACEs between the two groups was consistent across a variety of subgroups. CONCLUSIONS: After adjusting for baseline differences, residual non-culprit LMCAD does not appear to increase the risk of MACEs at 12 months in patients undergoing emergent PCI for AMI complicated by CS.

Efficacy of thrombus aspiration in cardiogenic shock complicating acute myocardial infarction and high thrombus burden.

INTRODUCTION AND OBJECTIVES: Current guidelines do not recommend routine thrombus aspiration in acute myocardial infarction (AMI) because no benefits were observed in previous randomized trials. However, there are limited data in cardiogenic shock (CS) complicating AMI. METHODS: We included 575 patients with AMI complicated by CS. The participants were stratified into the TA and no-TA groups based on use of TA. The primary outcome was a composite of 6-month all-cause death or heart failure rehospitalization. The efficacy of TA was additionally assessed based on thrombus burden (grade I-IV vs V). RESULTS: No significant difference was found in in-hospital death (28.9% vs 33.5%; P=.28), or 6-month death, or heart failure rehospitalization (32.4% vs 39.4%; HRadj: 0.80; 95%CI, 0.59-1.09; P=.16) between the TA and no-TA groups. However, in 368 patients with a higher thrombus burden (grade V), the TA group had a significantly lower risk of 6-month all-cause death or heart failure rehospitalization than the no-TA group (33.4% vs 46.3%; HRadj: 0.59; 95%CI, 0.41-0.85; P=.004), with significant interaction between thrombus burden and use of TA for primary outcome (adjusted Pint=.03). CONCLUSIONS: Routine use of TA did not reduce short- and mid-term adverse clinical outcomes in patients with AMI complicated by CS. However, in select patients with a high thrombus burden, the use of TA might be associated with improved clinical outcomes. The study was registered at ClinicalTrials.gov (Identifier: NCT02985008).

Inodilators May Improve the In-Hospital Mortality of Patients with Cardiogenic Shock Undergoing Veno-Arterial Extracorporeal Membrane Oxygenation.

Although inodilators (dobutamine and milrinone) are widely used empirically for cardiogenic shock (CS), the efficacy of inodilators for patients with CS undergoing veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is controversial. We evaluated the effects of inodilators on clinical outcomes using the RESCUE (REtrospective and prospective observational Study to investigate Clinical oUtcomes and Efficacy of left ventricular assist device for Korean patients with cardiogenic shock; NCT02985008) registry. We selected and analyzed the clinical outcomes of 496 patients who underwent VA-ECMO and did or did not receive inodilators. Of the 496 patients, 257 (51.8%) died during hospitalization. We selected 191 matched pairs to adjust for baseline clinical characteristics after 1:1 propensity score matching (PSM). The univariate and multivariate analyses showed that the inodilator group had significantly lower in-hospital mortality than the no-inodilator group (unadjusted hazard ratio [HR], 0.768; 95% confidence interval [CI], 0.579-1.018; p = 0.066, adjusted HR, 0.702; 95% CI, 0.552-0.944; p = 0.019). For patients with CS undergoing VA-ECMO, inodilators may improve clinical outcomes.

Impact of the Obesity Paradox Between Sexes on In-Hospital Mortality in Cardiogenic Shock: A Retrospective Cohort Study.

Background Several studies have shown that obesity is associated with better outcomes in patients with cardiogenic shock (CS). Although this phenomenon, the "obesity paradox," reportedly manifests differently based on sex in other disease entities, it has not yet been investigated in patients with CS. Methods and Results A total of 1227 patients with CS from the RESCUE (Retrospective and Prospective Observational Study to Investigate Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock) registry in Korea were analyzed. The study population was classified into obese and nonobese groups according to Asian Pacific criteria (BMI ≥25.0 kg/m2 for obese). The clinical impact of obesity on in-hospital mortality according to sex was analyzed using logistic regression analysis and restricted cubic spline curves. The in-hospital mortality rate was significantly lower in obese men than nonobese men (34.2% versus 24.1%, respectively; P=0.004), while the difference was not significant in women (37.3% versus 35.8%, respectively; P=0.884). As a continuous variable, higher BMI showed a protective effect in men; conversely, BMI was not associated with clinical outcomes in women. Compared with patients with normal weight, obesity was associated with a decreased risk of in-hospital death in men (multivariable-adjusted odds ratio [OR], 0.63; CI, 0.43-0.92 [P=0.016]), but not in women (multivariable-adjusted OR, 0.94; 95% CI, 0.55-1.61 [P=0.828]). The interaction P value for the association between BMI and sex was 0.023. Conclusions The obesity paradox exists and apparently occurs in men among patients with CS. The differential effect of BMI on in-hospital mortality was observed according to sex. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02985008.

Prognostic Impact of Plasma Glucose on Patients With Cardiogenic Shock With or Without Diabetes Mellitus from the SMART RESCUE Trial.

Although the presence of hyperglycemia has been shown to affect the clinical outcome of patients with cardiogenic shock, the extent of hyperglycemia and its association with prognosis have not been fully addressed in a large population. A total of 1,177 consecutive patients with cardiogenic shock were enrolled from January 2014 to December 2018 at 12 hospitals in South Korea. The primary outcome was in-hospital mortality. Patients were divided into 4 groups according to their initial plasma glucose level in patients with diabetes mellitus (DM) (n = 752) and patients without DM (n=425); group 1 (≤8 mmol/L or 144 mg/100 ml), group 2 (8 to 12 mmol/L or 144 to 216 mg/100 ml), group 3 (12 to 16 mmol/L or 216 to 288 mg/100 ml), and group 4 (≥16 mmol/L or 288 mg/100 ml). The groups with higher admission plasma glucose were associated with lower systolic blood pressure and higher lactic acid levels in patients with and without DM. In-hospital mortality increased in groups with higher admission plasma glucose level in patients without DM (group 1:24.2%, group 2: 28.6%, group 3: 38.1%, group 4: 49.0%, p <0.01), whereas in patients with DM, mortality and admission plasma glucose level showed no significant association (group 1: 45%, group 2: 35.4%, group 3: 33.3%, group 4: 43.1%, p = 0.26). Even after multivariate analysis, high plasma glucose was an independent predictor of in-hospital mortality in patients without DM. In patients with cardiogenic shock, plasma glucose obtained at admission was associated with in-hospital mortality in patients without DM.

Impact of chronic kidney disease on clinical outcomes in patients with Stage B progressive aortic regurgitation (mild to moderate and moderate grades).

BACKGROUND: Chronic kidney disease (CKD) is a significant comorbidity in patients with heart failure and valvular heart disease. Renal impairment is not well evaluated in the patients with Stage B progressive aortic regurgitation (AR) (mild to moderate and moderate grades in this study), for estimating outcome. HYPOTHESIS: We sought to investigate the prognostic factor, especially CKD, in the patients with progressive AR. METHODS: We enrolled 262 patients with Stage B progressive AR and preserved left ventricular systolic function (ejection fraction ≥ 50%). Based on the presence of CKD, the patients were divided into CKD (n = 70) and non-CKD (n = 192) groups, which CKD was defined as estimated glomerular filtration rate < 60 ml/min/1.73 m2 . The primary outcome was major adverse cardiac events (MACEs), including cardiac death, myocardial infarction, hospitalization for heart failure, and aortic valve replacement. RESULTS: The median follow-up duration was 41.5 (interquartile range: 16.2-71.7) months. Between groups, the CKD patients were older; they had a higher pulse pressure and higher incidence of hypertension, diabetes mellitus, dyslipidemia, cerebrovascular accident, and atrial fibrillation. Compared to the non-CKD group, the CKD group had lower e' velocity (4.36 ± 2.21 vs. 5.20 ± 2.30 cm/s, p = .009), higher right ventricular systolic pressure (38.02 ± 15.79 vs. 33.86 ± 11.77 mmHg, p = .047). The CKD group was associated with increased risk of MACEs (41.4% vs. 22.4%; unadjusted hazard ratio [HR]: 1.78, 95% confidence interval [CI]: 1.11-2.85, p = .017). In multivariate Cox regression analyses, the risk of MACEs was significantly different between groups (adjusted HR: 1.71, 95% CI: 1.11-2.62, p = .015); furthermore, the risk of hospitalization for heart failure (10.0% vs. 2.6%; adjusted HR: 2.30, 95% CI: 1.16-4.55, p = .017) was significantly higher in the CKD group than in the non-CKD group. CONCLUSIONS: In patients with Stage B progressive AR, CKD is an independent prognostic factor for clinical outcomes (composite clinical outcome, hospitalization for heart failure).

Efficacy and Safety of Fenofibrate-Statin Combination Therapy in Patients With Inadequately Controlled Triglyceride Levels Despite Previous Statin Monotherapy: A Multicenter, Randomized, Double-blind, Phase IV Study.

PURPOSE: Residual cardiovascular risk reduction by fenofibrate in patients with high serum triglyceride (TG) levels despite previous statin monotherapy is not well characterized. The purpose of this study was to evaluate the efficacy and safety of a combination of choline fenofibrate and statin in patients with inadequately controlled TG levels despite previous statin monotherapy. METHODS: This prospective, multicenter, randomized, double-blind study was conducted in Korea. A total of 133 patients with controlled LDL-C but elevated TG levels, already receiving statin monotherapy, were enrolled in the study, which was conducted from July 2018 to December 2019. Patients were randomly assigned to receive combination therapy with choline fenofibrate and statin or statin monotherapy in a 1:1 ratio. After 8 weeks of treatment, the lipid profiles and safety parameters of the patients in the 2 groups were compared. FINDINGS: The study included 127 patients (64 in the combination group and 63 in the control group) older than 19 years. After 8 weeks of therapy, mean serum TG levels significantly decreased from 269.8 to 145.5 mg/dL (P < 0.0001) in the combination therapy group, whereas no significant changes occurred in the statin monotherapy group (from 271.1 to 280.5 mg/dL). Contrarily, the mean serum HDLC levels significantly increased from 45.0 to 50.4 mg/dL (P = 0.0004) in the combination therapy group, whereas there were no significant changes in the monotherapy group (from 44.3 to 44.7 mg/dL). There were no additional serious adverse events in the combination therapy group compared with the statin monotherapy group. IMPLICATIONS: The combination therapy using choline fenofibrate and statin was found to be effective in serum TG control and likely tolerable in patients with high TG levels despite statin monotherapy. A larger study, conducted for a longer duration, is needed to evaluate the effectiveness of this combination in reducing cardiovascular risk. ClinicalTrials.gov identifier: NCT03874260.

Central blood pressure lowering effect of telmisartan-rosuvastatin single-pill combination in hypertensive patients combined with dyslipidemia: A pilot study.

This multicenter, phase 4, Prospective Randomized Open, Blinded End-point (PROBE) study aimed to evaluate safety and efficacy of telmisartan/rosuvastatin single-pill combination (SPC) therapy on lowering central blood pressure (BP) compared with telmisartan monotherapy in hypertensive patients with dyslipidemia in Korea. Study was terminated earlier than planned due to COVID-19 pandemic, thus should be considered as a pilot study. Among 125 patients who met the inclusion criteria of hypertension and dyslipidemia (defined as 10-year Atherosclerotic Cardiovascular Disease risk score over 5%), 80 patients went through 4-week single-group run-in period with telmisartan 40-80 mg, then randomized to telmisartan 80 mg + rosuvastatin (10 or 20 mg) SPC group or telmisartan 80 mg monotherapy group. The central/brachial BP, brachial-ankle pulse wave velocity (baPWV), and augmentation index (AIx) were assessed at baseline and 16 weeks later. Mean brachial SBP changed from 135.80 ± 14.22 mmHg to 130.69 ± 13.23 mmHg in telmisartan/rosuvastatin group and from 134.37 ± 12.50 mmHg to 133.75 ± 12.30 mmHg in telmisartan monotherapy group without significant difference (between-group difference p = .149). Mean central SBP were reduced significantly in the telmisartan/rosuvastatin group with change from 126.72 ± 14.44 mmHg to 121.56 ± 14.56 mmHg while telmisartan monotherapy group showed no significant change (between-group difference p = .028). BaPWV changed from 1672.57 ± 371.72 m/s to 1591.75 ± 272.16 m/s in telmisartan/rosuvastatin group and from 1542.85 ± 263.70 m/s to 1586.12 ± 297.45 m/s in telmisartan group with no significance (between-group difference p = .078). Change of AIx had no significant difference (between-group difference p = .314). Both groups showed excellent compliance rate of 96.9 ± 4.5% with no significant difference in adverse rate. Telmisartan/rosuvastatin SPC therapy was more effective in lowering central BP compared with the telmisartan monotherapy. The results of this study showed benefit of additive statin therapy in hypertensive patients combined with dyslipidemia.

Elective Laparoscopic Cholecystectomy Is Better than Conservative Treatment in Elderly Patients with Acute Cholecystitis After Percutaneous Transhepatic Gallbladder Drainage.

BACKGROUND: It is unclear whether cholecystectomy is beneficial after percutaneous transhepatic gallbladder drainage (PTGBD) in elderly patients with acute cholecystitis (AC). METHODS: This single-center, retrospective study included 202 patients aged >80 years with AC without common bile duct (CBD) stones who underwent PTGBD between January 2010 and December 2019. RESULTS: One hundred and forty-two patients underwent elective laparoscopic cholecystectomy (ELC), and 60 underwent conservative treatment, specifically PTGBD removal (PTGBD-R) in 36 patients and PTGBD maintained (PTGBD-M) in 24 patients. The postoperative major complication (POMC) rate in the ELC group was 8.5%. The cumulative incidence for recurrence of biliary events (BE) in the PTGBD-R group was 22.2%. The cumulative incidence for PTGBD-related complication in the PTGBD-M group was 70.8%. Mortality after initial treatment was not significantly different between the three groups (2.8% vs. 2.8% vs. 8.3%, p=0.381). In multivariate analysis, a Charlson age comorbidity index ≥6 and body mass index ≤19 were significant risk factors for POMC after ELC, and a closed cystic duct was a significant risk factor for recurrent BE after PTGBD-R. CONCLUSION: ELC is recommended in AC after PTGBD for selected patients aged >80 years without CBD stones due to the high recurrence rate of BE after PTGBD-R and the difficulty associated with PTGBD-M.

Comparison of in-hospital outcomes of patients with vs. without ischaemic cardiomyopathy undergoing veno-arterial-extracorporeal membrane oxygenation.

AIMS: This study aimed to investigate differences in baseline and treatment characteristics, and in-hospital mortality according to the aetiologies of cardiogenic shock in patients undergoing veno-arterial-extracorporeal membrane oxygenation (VA-ECMO). METHODS AND RESULTS: The RESCUE registry is a multicentre, observational cohort that includes 1247 patients with cardiogenic shock from 12 centres. A total of 496 patients requiring VA-ECMO were finally selected, and the study population was stratified by cardiogenic shock aetiology [ischaemic cardiomyopathy (ICM, n = 342) and non-ICM (NICM, n = 154)]. The primary outcome of interest was in-hospital mortality. Sensitivity analyses including propensity-score matching adjustments were performed. Mean age of the entire population was 61.8 ± 14.2, and 30.8% were women. There were significant differences in baseline characteristics; notable differences included the older age of patients with ICM (65.1 ± 13.7 vs. 58.2 ± 13.8, P < 0.001), preponderance of males [258 (75.4%) vs. 85 (55.2%), P < 0.001], and higher prevalence of diabetes mellitus [140 (40.9%) vs. 39 (25.3%), P = 0.001] compared with patients in the NICM aetiology group. Patients with ischaemic cardiogenic shock were more likely to have longer shock duration before VA-ECMO implantation (518.7 ± 941.4 min vs. 292.4 ± 707.8 min, P = 0.003) and were less likely to undergo distal limb perfusion than those with NICM [108 (31.6%) vs. 79 (51.3%), P < 0.001]. In-hospital mortality in the overall cohort was 52.2%; patients with ICM had a higher unadjusted risk of in-hospital mortality [203 (59.4%) vs. 56 (36.4%); unadjusted hazard ratio, 2.295; 95% confidence interval, 1.698-3.100; P < 0.001]. There were no significant differences in the primary outcome between the two aetiologies following propensity-score matching multiple adjustments (adjusted hazard ratio, 1.265; 95% confidence interval, 0.840-1.906; P = 0.260). CONCLUSIONS: Results of the current study indicated among patients with cardiogenic shock undergoing VA-ECMO, ischaemic aetiology does not seem to impact in-hospital mortality. These findings underline that early initiation and appropriate treatment strategies of VA-ECMO for patients with ICM shock are required.

Clinical Characteristics and Predictors of In-Hospital Mortality in Patients With Cardiogenic Shock: Results From the RESCUE Registry.

BACKGROUND: In the current era of mechanical circulatory support, limited data are available on prognosis of cardiogenic shock (CS) caused by various diseases. We investigated the characteristics and predictors of in-hospital mortality in Korean patients with CS. METHODS: The RESCUE study (Retrospective and Prospective Observational Study to Investigate Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With CS) is a multicenter, retrospective, and prospective registry of patients that presented with CS. Between January 2014 and December 2018, 1247 patients with CS were enrolled from 12 major centers in Korea. The primary outcome was in-hospital mortality. RESULTS: In-hospital mortality rate was 33.6%. The main causes of shock were ischemic heart disease (80.7%), dilated cardiomyopathy (6.1%), myocarditis (3.2%), and nonischemic ventricular arrhythmia (2.5%). Vasopressors were used in 1081 patients (86.7%). The most frequently used vasopressor was dopamine (63.4%) followed by norepinephrine (57.3%). An intraaortic balloon pump was used in 314 patients (25.2%) and extracorporeal membrane oxygenator in 496 patients (39.8%). In multivariable analysis, age ≥70years (odds ratio [OR], 2.73 [95% CI, 1.89-3.94], P<0.001), body mass index <25 kg/m2 (OR, 1.52 [95% CI, 1.08-2.16], P=0.017), cardiac arrest at presentation (OR, 2.16 [95% CI, 1.44-3.23], P<0.001), vasoactive-inotrope score >80 (OR, 3.55 [95% CI, 2.54-4.95], P<0.001), requiring continuous renal replacement therapy (OR, 4.14 [95% CI, 2.88-5.95], P<0.001), mechanical ventilator (OR, 3.17 [95% CI, 2.16-4.63], P<0.001), intraaortic balloon pump (OR, 1.55 [95% CI, 1.07-2.24], P=0.020), and extracorporeal membrane oxygenator (OR, 1.85 [95% CI, 1.25-2.76], P=0.002) were independent predictors for in-hospital mortality. CONCLUSIONS: The in-hospital mortality of patients with CS remains high despite the high utilization of mechanical circulatory support. Age, low body mass index, cardiac arrest at presentation, amount of vasopressor, and advanced organ failure requiring various support devices were poor prognostic factors for in-hospital mortality. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02985008.