Is Prophylactic Tricuspid Annuloplasty Beneficial for Degenerative Mitral Valve Repair?

BACKGROUND: This study aimed to evaluate the long-term clinical impacts of prophylactic tricuspid annuloplasty (TAP) in patients with mild tricuspid regurgitation (TR) who underwent mitral valve repair. METHODS: One hundred fifty-one patients with mild TR who underwent mitral valve repair for degenerative mitral regurgitation between 1997 and 2013 were categorized into the TAP (n = 85) or no TAP (n = 66) groups. The indications for TAP were atrial fibrillation and tricuspid annular dilatation. The mean follow-up duration was 115.5 ± 48.6 months. Inverse probability of treatment weighting analysis and propensity score matching with 53 patients in each group were used to adjust for the baseline differences between the 2 groups. RESULTS: There were no early mortalities in either group, and early morbidities, including heart block, were not different between the groups. Inverse probability of treatment weighting-adjusted survival analysis did not reveal any difference in overall survival (P = .862), freedom from cardiac-related mortality (P = .535), or major adverse valve-related events (P = .972) between the groups. There was no difference in late TR progression (moderate or greater) between the groups (P = .316). These results were consistent in the matched analysis. CONCLUSIONS: Prophylactic TAP in mild TR may not have a beneficial effect on TR progress in degenerative mitral regurgitation. Further large studies are necessary to define the role of prophylactic TAP in mild TR.

Interobserver Variability and Diagnostic Performance of Gadoxetic Acid-enhanced MRI for Predicting Microvascular Invasion in Hepatocellular Carcinoma.

Background Accurate identification of microvascular invasion (MVI) in hepatocellular carcinoma (HCC) before treatment is critical for selecting a proper treatment strategy. Purpose To evaluate the interobserver agreement and the diagnostic performance of the MRI assessment of MVI in HCC according to the level of radiologist experience. Materials and Methods This retrospective study included 100 patients with surgically confirmed HCCs smaller than 5 cm who underwent gadoxetic acid-enhanced MRI between 2013 and 2016. Eight postfellowship radiologists (four with 7-13 years of experience [more experienced] and four with 3-6 years of experience [less experienced]) evaluated four imaging features (nonsmooth tumor margin, irregular rim-like enhancement in the arterial phase, peritumoral arterial phase hyperenhancement, peritumoral hepatobiliary phase hypointensity) and assigned the possibility of MVI. Interobserver agreement was determined by using Fleiss κ statistics according to reviewer experience and tumor size (≤3 cm vs >3 cm). With reference standards of histopathologic specimens, the diagnostic performance in the identification of MVI was assessed by using receiver operating characteristic curve analysis. Results In 100 patients (mean age, 58 years ± 10 [standard deviation]; 70 men) with 100 HCCs (mean size, 2.8 cm ± 0.9), 39 (39%) HCCs had MVI. The overall interobserver agreement was fair to moderate for the imaging features and their combinations (κ = 0.38-0.47) and MVI probability (κ = 0.41; 95% confidence interval: 0.33, 0.45). More experienced reviewers demonstrated higher agreement in MVI probability than less experienced reviewers (κ = 0.55 vs 0.36, respectively; P = .002). Diagnostic performance of each reviewer was modest for MVI prediction (area under the receiver operating characteristic curve [AUC] range, 0.60-0.74). The AUCs for the diagnosis of MVI were lower for HCCs larger than 3 cm (range, 0.55-0.69) than for those less than or equal to 3 cm (range, 0.59-0.75). Conclusion Considerable interobserver variability exists in the assessment of microvascular invasion in hepatocellular carcinoma using MRI, even for more experienced radiologists. © RSNA, 2020 Online supplemental material is available for this article. See also the editorial by Tang in this issue.

Outcomes of transported and in-house patients on extracorporeal life support: a propensity score-matching study.

OBJECTIVES: Patients on extracorporeal life support (ECLS), like other critically ill patients, are transported to other institutions for various reasons. However, little has been reported concerning the characteristics and clinical outcomes of transported patients compared with those of in-house patients. METHODS: A total of 281 adult patients received ECLS between January 2014 and August 2016. Patients who underwent cannulation at another institution by our team were excluded. Patients were divided into 2 groups: transported group (N = 46) and in-house group (N = 235). All 46 patients were safely transported without serious adverse events. The mean travel distance was 206±140 km, with a mean travel time of 78 ± 57 min. Following propensity score matching, 44 transported patients were matched to 148 in-house patients. RESULTS: In the matched population, the mean age was 48 ± 13 years in the transported group and 49 ± 17 years in the in-house group (P = 0.70). The ECLS type (venoarterial/venovenous) comprised 35/9 (79.5/20.5%) in the transported group and 119/29 (80.4/19.6%) in the in-house group (P = 0.93). Seventeen (38.6%) extracorporeal cardiopulmonary resuscitations were performed in the transported group and 59 (39.9%) were performed in the in-house group (P = 0.91). The incidence of limb ischaemia and acute kidney injury was higher in the transported group (P = 0.007 and P = 0.001, respectively). However, the rate of survival to discharge did not differ between the groups (63.6% in the transported group vs 64.2% in the in-house group, P = 0.94) and there was no difference in overall mortality (P = 0.99). CONCLUSIONS: Although transported patients had more complications than in-house ECLS patients, clinical outcomes were comparable in the matched population. Transporting ECLS patients to an experienced centre may be justified based on our experience.

Late clinical outcomes after mechanical aortic valve replacement for aortic stenosis: old versus new prostheses.

BACKGROUND: The study aimed to evaluate the late clinical outcomes of new-generation mechanical valves for severe aortic stenosis (AS) compared with old mechanical valves. METHODS: We retrospectively reviewed data from 254 patients with severe AS, who underwent primary mechanical aortic valve replacement from 1995 to 2013. Patients were classified into two groups: old-valve group (n=65: 33 ATS standard, 32 Medtronic-Hall) and new-valve group (n=189: 113 St. Jude Regent, 46 On-X, 30 Sorin Overline). Median patient age was 58 years (Q1-Q3: 52-61). With propensity score matching based on demographic information, 56 patients in the old-valve group were matched with 177 patients in the new-valve group. The median follow-up duration was 91 months (Q1-Q3: 48-138). RESULTS: Cardiac-related mortality and hemorrhagic events were significantly lower in the new-valve group (P=0.047 and P=0.032, respectively). The median international normalized ratio (INR) at follow-up was significantly higher in the old-valve group [2.23, Q1-Q3: 2.14-2.35 (old-valve group); 2.08, Q1-Q3: 1.92-2.23 (new-valve group), P<0.001]. The incidence of prosthesis-patient mismatch (PPM) was significantly higher in the old-valve group (P<0.001). Multivariate analysis of the total population revealed that PPM was a significant risk factor for cardiac-related events [hazard ratio (HR) =5.279, 95% CI, 1.886-14.561, P=0.002] and showed higher trend of increasing mortality (HR =3.082, P=0.076). CONCLUSIONS: New mechanical prostheses showed a better hemodynamic performance and lower incidence of PPM. Anticoagulation strategy to lower the target INR in patients with new mechanical valves may improve late outcomes by reducing hemorrhagic events.

Revascularization vs. Medical Therapy for Coronary Chronic Total Occlusions in Patients With Chronic Kidney Disease.

BACKGROUND: We investigated whether the outcome of revascularization differed from the outcome of medical therapy in chronic kidney disease (CKD) and non-CKD patients with chronic total occlusion (CTO).Methods and Results:A total of 2,010 patients with CTO who underwent revascularization (n=1,355), including percutaneous coronary intervention (n=878) and coronary artery bypass grafting (n=477), or had medical therapy alone (n=655) were examined. The primary outcome was all-cause death during follow-up. Among the non-CKD patients (n=1,679), revascularization had a lower incidence of all-cause death (adjusted hazard ratio [HR] 0.54, 95% confidence interval [CI] 0.41-0.72, P<0.001) compared with medical therapy. Among the CKD patients (n=331), the difference in the incidence of all-cause death was not as marked between the 2 treatments (adjusted HR 0.71, 95% CI 0.48-1.06, P=0.09). There was a significant interaction between kidney function and treatment strategy (revascularization vs. medical therapy) on all-cause death (P for interaction=0.014). CONCLUSIONS: Based on the clinical outcomes, in CTO patients with preexisting CKD, revascularization via PCI or bypass surgery might not be as effective as in non-CKD patients.

Classification and regression tree model for predicting tracheostomy in patients with traumatic cervical spinal cord injury.

PURPOSE: In patients with cervical spinal cord injury (CSCI), respiratory compromise and the need for tracheostomy are common. The purpose of this study was to identify common risk factors for tracheostomy following traumatic CSCI and develop a decision tree for tracheostomy in traumatic CSCI patients without pulmonary function test. METHODS: Data of 105 trauma patients with CSCI admitted in our institution from April, 2008 to February, 2014 were retrospectively analyzed. Patients who underwent tracheostomy were compared to those who did not. Stepwise logistic regression analysis and classification and regression tree model were used to predict the risk factors for tracheostomy. RESULTS: Tracheostomy was performed in 20% of patients with traumatic CSCI on median hospital day 4. Patients who underwent tracheostomy tended to be more severely injured (higher Injury Severity Score, lower Glasgow Coma Score, and lower systolic blood pressure on admission) which required more frequent intubation in the emergency room (ER) with a higher rate of complete CSCI compared to those who did not. Upon multiple logistic analysis, Age ≥ 55 years (OR: 6.86, p = 0.037), Car accident (OR: 5.8, p = 0.049), injury above C5 (OR: 28.95, p = 0.009), ISS ≥ 16 (OR: 12.6, p = 0.004), intubation in the ER (OR: 23.87, p = 0.001), and complete CSCI (OR: 62.14, p < 0.001) were significant predictors for the need of tracheostomy after CSCI. These factors can predict whether a new patient needs future tracheostomy with 91.4% accuracy. CONCLUSIONS: Age ≥ 55 years, injury above C5, ISS ≥ 16, Car accident, intubation in the ER, and complete CSCI were independently associated with tracheostomy after CSCI. CART analysis may provide an intuitive decision tree for tracheostomy.

Morphine Does Not Affect Myocardial Salvage in ST-Segment Elevation Myocardial Infarction.

Recent studies have proposed intravenous (IV) morphine is associated with delayed action of antiplatelet agents in acute myocardial infarction. However, it is unknown whether morphine results in increased myocardial damage in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI). We investigated myocardial salvage index (MSI) to determine whether IV morphine affects myocardial injury adversely in STEMI patients undergoing primary PCI. 299 STEMI patients underwent contrast-enhanced magnetic resonance imaging a median of 3 days after PCI. Infarct size was measured on delayed-enhancement imaging, and area at risk was quantified on T2-weighted imaging. MSI was calculated as '[area at risk-infarct size] X 100 / area at risk'. IV morphine was administrated in 32.1% of patients. Patients treated with morphine had shorter symptom to balloon time and higher prevalence of Thrombolysis in Myocardial Infarction flow grade 0 or 1. The morphine group showed a trend toward larger MSI and infarct size and significantly greater area at risk than the non-morphine group. After propensity score matching (90 pairs), MSI was similar between the morphine and non-morphine group (46.1% versus 43.5%, P = .11), and infarct size and area at risk showed no difference. In propensity score-matched analysis, IV morphine prior to primary PCI in STEMI patients did not cause adverse impacts on myocardial salvage.

Impact of Metformin Use on Lactate Kinetics in Patients with Severe Sepsis and Septic Shock.

BACKGROUND: We aimed to evaluate the impact of metformin use on lactate kinetics in patients with severe sepsis and septic shock. METHODS: We analyzed data from a registry that included patients who presented to the emergency department and met criteria for severe sepsis or septic shock. Patients were divided into two groups based on metformin use. We compared lactate concentrations, lactate clearance (LC), and normalization at 6 h (H6) and 24 h (H24) after the initial (H0) measurement. Propensity score matching, multiple logistic, and linear regression analysis via a generalized estimating equations method were used. RESULTS: Of 1,318 patients, 71 patients were in the metformin use group and all 71 were selected in a one to two propensity matching. Metformin users showed significantly higher lactate levels at H0 (5.3 vs. 4.4 mmol/L) and H6 (3.8 vs. 2.9 mmol/L) in all patients, although in the matched subset, the effect was marginal (H0, 5.3 vs. 4.9 mmol/L; H6, 3.8 vs. 3.2 mmol/L; H24, 2.7 vs. 2.4 mmol/L). Mean LC (H6, 29% vs. 34%; H24, 43% vs. 49%) and normalization rate (H6, 27% vs. 28%; H24, 49% vs. 52%) were also not significantly different. Although metformin use appeared to be associated with higher lactate levels before using the propensity score method, no significant association was found between metformin use and lactate kinetics variables in the balanced matched subset data. CONCLUSIONS: Lactate levels in metformin users were initially elevated in the early phase of resuscitation from severe sepsis and septic shock. However, there was no significant difference in lactate levels, LC, and normalization over the initial 24 h period based on metformin use.

Transarterial chemoembolization versus resection for intermediate-stage (BCLC B) hepatocellular carcinoma.

BACKGROUND/AIMS: Several studies have suggested that surgical resection (SR) can provide a survival benefit over transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) at the intermediate stage according to the Barcelona Clinic Liver Cancer (BCLC) staging system. However, the criteria for SR remain to be determined. This study compared the long-term outcome of intermediate-stage HCC patients treated by either TACE or SR as a primary treatment modality, with the aim of identifying the patient subgroup that gained a survival benefit by either modality. METHODS: In total, 277 BCLC intermediate-stage HCC patients treated by either TACE (N=225) or SR (N=52) were analyzed. RESULTS: The overall median survival time was significantly better for SR than TACE (61 vs. 30 months, P=0.002). Decisiontree analysis divided patients into seven nodes based on tumor size and number, serum alpha-fetoprotein (AFP) level, and Child-Pugh score, and these were then simplified into four subgroups (B1-B4) based on similarities in the overall hazard rate. SR provided a significant survival benefit in subgroup B2, characterized by 'oligo' (2-4) nodules of intermediate size (5-10 cm) when the AFP levels was <400 ng/ml, or 'oligo' (2-4) nodules of small to intermediate size (<10 cm) plus a Child-Pugh score of 5 when the AFP level was ≥400 ng/mL (median survival 73 vs. 28 months for SR vs. TACE respectively; P=0.014). The survival rate did not differ significantly between SR and TACE in the other subgroups (B1 and B3). CONCLUSION: SR provided a survival benefit over TACE in intermediate-stage HCC, especially for patients meeting certain criteria. Re-establishing the criteria for optimal treatment modalities in this stage of HCC is needed to improve survival rates.

Clinical and hemodynamic influences of prophylactic tricuspid annuloplasty in mechanical mitral valve replacement.

OBJECTIVE: The aim of this study was to evaluate the long-term clinical and hemodynamic influences of prophylactic tricuspid annuloplasty (TAP) in patients with less-than-moderate tricuspid regurgitation (TR) who underwent mitral valve replacement (MVR). METHODS: Between November 1994 and December 2010, 293 patients with less-than-moderate TR who underwent primary mechanical MVR were categorized into 2 groups: TAP (n = 151) or no TAP (n = 142). The median age was 51 years (quartile (Q)1-Q3, 43-59 years). The cause of valve pathology was rheumatic in 92.5% of patients (n = 271). The prevalence of preoperative atrial fibrillation was in 73.0%. Using propensity score matching based on demographic information, 91 TAP patients could be matched to 91 no TAP patients. Median follow-up duration was 107 months (Q1-Q3, 76-162 months). RESULTS: There was no early mortality in either group. Early morbidities, including heart block were not different between groups. Although overall survival and freedom from cardiac-related mortality did not differ between groups (P = .519 and P = .115, respectively), freedom from recurrence of moderate or higher TR grade were significantly higher in the TAP group (P = .043). In subgroup analyses, these group differences of TAP were especially prominent in patients with sinus rhythm compared with patients with atrial fibrillation at discharge (P = .047 vs P = .460). CONCLUSIONS: Prophylactic TAP for patients with less-than-moderate TR grade who underwent mechanical MVR can prevent late TR progression without increasing early surgical risks. Longer-term follow-up is required to determine the clinical beneficial effect of prophylactic TAP.

On the role of Baseline measurements for crossover designs under the self and mixed carryover effects model.

It is well known that optimal designs are strongly model dependent. In this article, we apply the Lagrange multiplier approach to the optimal design problem, using a recently proposed model for carryover effects. Generally, crossover designs are not recommended when carryover effects are present and when the primary goal is to obtain an unbiased estimate of the treatment effect. In some cases, baseline measurements are believed to improve design efficiency. This article examines the impact of baselines on optimal designs using two different assumptions about carryover effects during baseline periods and employing a nontraditional crossover design model. As anticipated, baseline observations improve design efficiency considerably for two-period designs, which use the data in the first period only to obtain unbiased estimates of treatment effects, while the improvement is rather modest for three- or four-period designs. Further, we find little additional benefits for measuring baselines at each treatment period as compared to measuring baselines only in the first period. Although our study of baselines did not change the results on optimal designs that are reported in the literature, the problem of strong model dependency problem is generally recognized. The advantage of using multiperiod designs is rather evident, as we found that extending two-period designs to three- or four-period designs significantly reduced variability in estimating the direct treatment effect contrast.