Taek Kyu Park

Extracorporeal membrane oxygenation for refractory septic shock in adults

OBJECTIVES The role of extracorporeal membrane oxygenation (ECMO) remains controversial in adult patients with refractory septic shock. We sought to describe the clinical outcomes of adult patients supported by ECMO during septic shock refractory to conventional treatment. METHODS We analysed consecutive adult patients with refractory septic shock, assisted by an ECMO system between January 2005 and December 2013 in a single-centre registry. The primary outcome was survival to hospital discharge. RESULTS A total of 32 patients (21 males) received ECMO support for refractory septic shock. Of these, 14 patients (43.8%) had undergone cardiopulmonary resuscitation (CPR) and 7 patients (21.9%) did not achieve the return of spontaneous circulation until initiation of ECMO flow. ECMO was weaned off successfully in 13 patients (40.6%) and 7 patients (21.9%) survived to hospital discharge. The survivors had lower peak lactate (4.5 vs 15.1 mmol/l, P = 0.03), lower Sepsis-related Organ Failure Assessment day 3 score (15 vs 18, P = 0.01) and higher peak troponin I (32.8 vs 3.7 ng/ml, P = 0.02) than the non-survivors. None of the patients (31.3%) in whom ECMO was initiated more than 30.5 h after onset of septic shock, survived. In multivariable-adjusted models, CPR [adjusted hazard ratio (HR), 4.61; 95% confidence interval (CI), 1.55-13.69; P = 0.006] was an independent predictor of in-hospital mortality after ECMO in patients with refractory septic shock. Higher peak troponin I > 15 ng/ml (adjusted HR, 0.34; 95% CI, 0.12-0.97; P = 0.04) was associated with a lower risk of in-hospital mortality. CONCLUSIONS Survival to hospital discharge remained low in adult patients with refractory septic shock despite ECMO support. Our findings suggest that implantation of ECMO during refractory septic shock could be considered in patients with severe myocardial injury but should be avoided in patients who have received CPR.

Clinical characteristics and follow-up of Korean patients with adrenal incidentalomas.

Background/Aims We investigated the clinical characteristics and follow-up findings of subjects with adrenal incidentalomas in a single, tertiary-care hospital in South Korea. Methods The study consisted of a retrospective analysis of 282 adrenal incidentaloma patients who underwent radiographic and endocrinological evaluations at Samsung Medical Center in Seoul, South Korea, between January 2004 and July 2011. Results Most (86.2%) of the subjects were found to have nonfunctioning tumors. Functioning tumors were seen in 39 patients (13.8%). Among them, 28 (9.9%) had subclinical Cushing syndrome (SCS), six (2.1%) had pheochromocytoma, and five (1.8%) had primary hyperaldosteronism. Malignant adrenal tumors were discovered in three cases: two (0.7%) were primary adrenal cancers, and one (0.4%) was a secondary metastasis from a lung cancer. Significant risk factors for functional tumors were female gender (odds ratio [OR], 3.386; 95% confidence interval [CI], 1.611 to 7.117; p = 0.0013) and a noncontrast attenuation value of > 10 Hounsfield units (OR, 2.806; 95% CI, 1.231 to 6.397; p = 0.0141). During follow-up (mean, 22.5 months) of 72 of the patients, three (4.2%) developed hormonal changes due to functional tumors. One was confirmed as pheochromocytoma by histopathology, and the others were diagnosed with SCS and followed routinely without surgical intervention. No malignant transformation was found in these patients. Conclusions Based on these findings, initial hormonal and radiographic evaluations for adrenal incidentalomas appear to be more important than follow-up tests because functional or malignant changes are rare.

Developing a risk prediction model for survival to discharge in cardiac arrest patients who undergo extracorporeal membrane oxygenation

BACKGROUND Limited data are available on a risk model for survival to discharge after extracorporeal membrane oxygenation (ECMO)-assisted cardiopulmonary resuscitation (ECPR). We aimed to develop a risk prediction model for survival to discharge in cardiac arrest patients who undergo ECMO. METHODS Between January 2004 and December 2012, 505 patients supported by ECMO were enrolled in a retrospective, observational registry. Among those, we studied 152 adult patients with in-hospital cardiac arrest. The primary outcome was survival to discharge. A new predictive scoring system, named the ECPR score, was developed to monitor survival to discharge using the β coefficients of prognostic factors from the logistic model, which were internally validated. RESULTS In-hospital death occurred in 104 patients (68.4%). In multivariate logistic regression, age ≤ 66, shockable arrest rhythm, CPR to ECMO pump-on time ≤ 38 min, post-ECMO arterial pulse pressure > 24 mmHg, and post-ECMO Sequential Organ Failure Assessment score ≤ 14 were independent predictors for survival to discharge. Survival to discharge was predicted by the ECPR score with a c-statistics of 0.8595 (95% confidence interval [CI], 0.80-0.92; p<0.001) which was similar to the c-statistics obtained from internal validation (training vs. test set; c-statistics, 0.86 vs. 0.86005; 95% CI, 0.80-0.92 vs. 0.77-0.94). The sensitivity and specificity for prediction of survival to discharge were 89.6% and 75.0%, respectively, when the ECPR score was >10. CONCLUSIONS The new risk prediction model might be helpful for decisions about ECPR management and could provide better information regarding early prognosis.

Optimal Strategy for Provisional Side Branch Intervention in Coronary Bifurcation Lesions: 3-Year Outcomes of the SMART-STRATEGY Randomized Trial.

OBJECTIVES This study compared the long-term follow-up results of conservative versus aggressive strategies for provisional side branch (SB) intervention in coronary bifurcation lesions. BACKGROUND The appropriate criteria for provisional SB ballooning or stenting have not been established. METHODS A total of 258 patients with a large bifurcation lesion were randomized to a conservative or aggressive SB intervention strategy. Different criteria applied for the initiation of SB intervention after main vessel stenting in the conservative and aggressive groups were Thrombolysis In Myocardial Infarction flow grade lower than 3 versus a stenosis diameter >75% for non-left main bifurcations, and a stenosis diameter >75% versus a stenosis diameter >50% for left main bifurcations. The primary endpoint was target vessel failure (TVF), defined as a composite of cardiac death, spontaneous myocardial infarction, or target vessel revascularization at 3 years. RESULTS At 3 years, TVF occurred in 11.7% of the conservative group versus 20.8% of the aggressive group (p = 0.049). Although no significant differences were observed in the incidence of TVF between groups at 1 year (9.4% vs. 9.2%; p = 0.97), landmark analysis between 1 and 3 years showed significantly less TVF in patients assigned to the conservative strategy (2.6% vs. 12.7%; p = 0.004). The crossover to the 2-stent technique was an independent predictor of TVF (hazard ratio: 5.42, 95% confidence interval: 2.03 to 14.5; p < 0.001). There was no interaction between left main bifurcation and treatment effects for TVF (p for interaction = 0.8). CONCLUSIONS A conservative strategy compared with an aggressive strategy for provisional SB intervention is associated with long-term benefits for patients with a large bifurcation lesion. (Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion; NCT00794014).

Long-Term Clinical Outcomes of True and Non-True Bifurcation Lesions According to Medina Classification – Results From the COBIS (COronary BIfurcation Stent) II Registry –

BACKGROUND Little is known about the clinical outcomes of patients with different types of coronary bifurcation lesions. We sought to compare long-term clinical outcomes of patients with true or non-true bifurcation lesions who underwent percutaneous coronary intervention. METHODSANDRESULTS We compared major adverse cardiac events (MACE: cardiac death, myocardial infarction [MI], or target lesion revascularization) between 1,502 patients with true bifurcation lesions (51.8%) and 1,395 with non-true bifurcation lesions (48.2%). True bifurcation lesions were defined as Medina classification (1.1.1), (1.0.1), or (0.1.1) lesions. During a median follow-up of 36 months, MACE occurred in 296 (10.2%) patients. Patients with true bifurcation lesions had a significantly higher risk of MACE than those with non-true bifurcation lesions (HR 1.39; 95% CI 1.08-1.80; P=0.01). Among true bifurcation lesions, Medina (1.1.1) and (0.1.1) were associated with a higher risk of cardiac death or MI than Medina (1.0.1) (HR 4.15; 95% CI 1.01-17.1; P=0.05). During the procedure, side branch occlusion occurred more frequently in Medina (1.1.1) and (1.0.1) than Medina (0.1.1) lesions (11.5% vs. 7.4%, P=0.03). CONCLUSIONS Patients with true bifurcation lesions had worse clinical outcomes than those with non-true bifurcation lesions. Procedural and long-term clinical outcomes differed according to the type of bifurcation lesion. These findings should be considered in future bifurcation studies.

6-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (SMART-DATE): a randomised, open-label, non-inferiority trial

BACKGROUND Current guidelines recommend dual antiplatelet therapy (DAPT) of aspirin plus a P2Y12 inhibitor for at least 12 months after implantation of drug-eluting stents (DES) in patients with acute coronary syndrome. However, available data about the optimal duration of DAPT in patients with acute coronary syndrome undergoing percutaneous coronary intervention are scant. We aimed to investigate whether a 6-month duration of DAPT would be non-inferior to the conventional 12-month or longer duration of DAPT in this population. METHODS We did a randomised, open-label, non-inferiority trial at 31 centres in South Korea. Patients were eligible if they had unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction, and underwent percutaneous coronary intervention. Enrolled patients were randomly assigned, via a web-based system by computer-generated block randomisation, to either the 6-month DAPT group or to the 12-month or longer DAPT group, with stratification by site, clinical presentation, and diabetes. Assessors were masked to treatment allocation. The primary endpoint was a composite of all-cause death, myocardial infarction, or stroke at 18 months after the index procedure in the intention-to-treat population. Secondary endpoints were the individual components of the primary endpoint; definite or probable stent thrombosis as defined by the Academic Research Consortium; and Bleeding Academic Research Consortium (BARC) type 2-5 bleeding at 18 months after the index procedure. The primary endpoint was also analysed per protocol. This trial is registered with ClinicalTrials.gov, number NCT01701453. FINDINGS Between Sept 5, 2012, and Dec 31, 2015, we randomly assigned 2712 patients; 1357 to the 6-month DAPT group and 1355 to the 12-month or longer DAPT group. Clopidogrel was used as a P2Y12 inhibitor for DAPT in 1082 (79·7%) patients in the 6-month DAPT group and in 1109 (81·8%) patients in the 12-month or longer DAPT group. The primary endpoint occurred in 63 patients in the 6-month DAPT group and in 56 patients in the 12-month or longer DAPT group (cumulative event rate 4·7% vs 4·2%; absolute risk difference 0·5%; upper limit of one-sided 95% CI 1·8%; pnon-inferiority=0·03 with a predefined non-inferiority margin of 2·0%). Although all-cause mortality did not differ significantly between the 6-month DAPT group and the 12-month or longer DAPT group (35 [2·6%] patients vs 39 [2·9%]; hazard ratio [HR] 0·90 [95% CI 0·57-1·42]; p=0·90) and neither did stroke (11 [0·8%] patients vs 12 [0·9%]; 0·92 [0·41-2·08]; p=0·84), myocardial infarction occurred more frequently in the 6-month DAPT group than in the 12-month or longer DAPT group (24 [1·8%] patients vs ten [0·8%]; 2·41 [1·15-5·05]; p=0·02). 15 (1·1%) patients had stent thrombosis in the 6-month DAPT group compared with ten (0·7%) in the 12-month or longer DAPT group (HR 1·50 [95% CI 0·68-3·35]; p=0·32). The rate of BARC type 2-5 bleeding was 2·7% (35 patients) in the 6-month DAPT group and 3·9% (51 patients) in the 12-month or longer DAPT group (HR 0·69 [95% CI 0·45-1·05]; p=0·09). Results from the per-protocol analysis were similar to those from the intention-to-treat analysis. INTERPRETATION The increased risk of myocardial infarction with 6-month DAPT and the wide non-inferiority margin prevent us from concluding that short-term DAPT is safe in patients with acute coronary syndrome undergoing percutaneous coronary intervention with current-generation DES. Prolonged DAPT in patients with acute coronary syndrome without excessive risk of bleeding should remain the standard of care. FUNDING Abbott Vascular Korea, Medtronic Vascular Korea, Biosensors Inc, and Dong-A ST.

Clinical outcomes of patients with acute myocardial infarction complicated by severe refractory cardiogenic shock assisted with percutaneous cardiopulmonary support.

Purpose Limited data are available on the role of percutaneous cardiopulmonary support (PCPS) for the treatment of acute myocardial infarction (AMI) patients with cardiogenic shock. We investigated the clinical outcomes and predictors of in-hospital mortality after PCPS in patients with AMI complicated by severe refractory cardiogenic shock. Materials and Methods From January 2004 to December 2011, we analyzed data from 96 consecutive AMI patients with cardiogenic shock assisted by a PCPS system. The primary outcome was in-hospital mortality. The predictors of in-hospital mortality were determined by a Cox proportional-hazards model. Results In-hospital mortality occurred in 51 (53.1%) patients and 58 (60.4%) patients were able to be weaned from PCPS. Cardiopulmonary resuscitation (CPR) was performed in 61 (63.5%) patients before PCPS initiation. On multivariate analysis, age ≥67 years [adjusted hazard ratio (HR), 4.74; 95% confidence interval (CI), 2.27-9.93; p<0.001], CPR (adjusted HR, 2.32; 95% CI, 1.11-4.85; p=0.03), lactate clearance for 48 hours <70% (adjusted HR, 2.50; 95% CI, 1.04-6.05; p=0.041), and unsuccessful revascularization (adjusted HR, 3.57; 95% CI, 1.85-6.90; p=0.002) were independent predictors of in-hospital mortality after PCPS in patients with AMI complicated by cardiogenic shock. Conclusion In spite of PCPS management, AMI patients complicated by severe refractory cardiogenic shock demonstrated high mortality. Older age, CPR, lower lactate clearance for 48 hours, and unsuccessful revascularization were independent predictors of in-hospital mortality.

Clopidogrel Versus Aspirin as an Antiplatelet Monotherapy After 12-Month Dual-Antiplatelet Therapy in the Era of Drug-Eluting Stents

Background—The use of dual-antiplatelet therapy (DAPT) exceeding 12 months may increase a bleeding risk despite a lower risk of ischemic events. There is no study to compare clinical outcomes in patients treated with a single-antiplatelet drug after DAPT in the era of drug-eluting stents (DES). We sought to investigate the efficacy and safety of clopidogrel versus aspirin monotherapy after 12-month DAPT after DES implantation using an institutional registry. Methods and Results—This observational study was conducted on consecutive patients receiving DES between January 2003 and December 2010. A total of 3243 patients receiving 12-month DAPT after DES implantation without adverse clinical outcomes were divided into 2 groups based on prescribed antiplatelet status: aspirin (n=2472) and clopidogrel (n=771). Clinical, angiographic, and procedural characteristics revealed more comorbidities and more complex lesions in the clopidogrel group than in the aspirin group. At 36 months after initiation of antiplatelet monotherapy, clopidogrel was associated with a reduction in risk for a composite of cardiac death, myocardial infarction, or stroke (aspirin versus clopidogrel; 3.8% versus 2.6%; hazard ratio, 0.54; 95% confidence interval, 0.32–0.92; P=0.02). The risk of cardiac death was lower with clopidogrel monotherapy than with aspirin monotherapy (1.4% versus 0.5%; hazard ratio, 0.31; 95% confidence interval, 0.11–0.93; P=0.04). Thrombolysis in myocardial infarction major bleeding occurred similarly between both groups (0.9% versus 1.3%; hazard ratio, 1.03; 95% confidence interval, 0.46–2.32; P=0.95). Conclusions—After 12-month DAPT, clopidogrel monotherapy, when compared with aspirin monotherapy, might be associated with a reduced risk of recurrent ischemic events in patients receiving DES.

Optimal Medical Therapy vs. Percutaneous Coronary Intervention for Patients With Coronary Chronic Total Occlusion - A Propensity-Matched Analysis.

BACKGROUND Limited data are available on the long-term clinical outcomes of coronary chronic total occlusion (CTO) patients who receive optimal medical therapy (OMT) compared with percutaneous coronary intervention (PCI). METHODS AND RESULTS Between March 2003 and February 2012, 2,024 patients with CTO were enrolled in a single-center registry. Among this patient group, we excluded CTO patients who underwent coronary artery bypass grafting and classified patients into the OMT group (n=664) or PCI group (n=883) according to initial treatment strategy. Propensity-score matching was also performed. The primary outcome was cardiac death. The median follow-up duration was 45.8 (interquartile range: 22.8-71.1) months. In the PCI group, 699 patients (79.2%) underwent successful revascularization. In the propensity-score matched population (533 pairs), there was no significant difference in the rate of cardiac death between the OMT and PCI groups (hazard ratio, 1.57; 95% confidence interval, 0.91-2.72, P=0.11). In the subgroup analysis, there were no significant interactions between the PCI strategy and cardiac death among several subgroups except that regarding collateral flow grades 0-2 vs. those with grade 3 (P=0.01). CONCLUSIONS As an initial treatment strategy, PCI did not reduce cardiac death compared with OMT for the treatment of CTO in the drug-eluting stent era.

Impact of a cardiac intensivist on mortality in patients with cardiogenic shock

BACKGROUND This study aimed to evaluate the association between high-intensity staffing by a dedicated cardiac intensivist and clinical outcomes in CS. METHODS We enrolled 2923 consecutive patients admitted to a cardiac care unit (CCU) from January 1, 2012 to December 31, 2015. In January 2013, the CCU changed from a low-intensity to high-intensity staffing unit managed by a dedicated cardiac intensivist. Patients were eligible if they required inotropes or vasopressors to maintain a systolic blood pressure>90mmHg, and had serum lactate≥2.0mmol/L. Eligible patients (n=513) were treated by low-intensity CCU (n=352) or high-intensity CCU (n=161). The primary outcome was CCU mortality. RESULTS CCU mortality occurred in 49 patients (30.6%) of the low-intensity group versus 62 patients (17.6%) of the high-intensity group (adjusted odds ratio [aOR] 0.44, 95% confidence interval [CI] 0.25-0.75, p<0.001). In-hospital mortality was not significantly different between the groups (33.1% vs 24.4%, aOR 0.75, 95% CI 0.43-1.29, p=0.29). Among 135 patients treated with extracorporeal membrane oxygenation, the high-intensity model was associated with lower CCU mortality (54.5% vs 22.5%, aOR 0.24, 95% CI 0.07-0.77, p=0.02) and in-hospital mortality (57.6% vs 29.4%, aOR 0.28, 95% CI 0.10-0.81, p=0.02). CONCLUSION High-intensity staffed CCU managed by a dedicated cardiac intensivist was associated with a significant reduction of CS-related mortality.