Bayesian response adaptive randomization design with a composite endpoint of mortality and morbidity.

Allocating patients to treatment arms during a trial based on the observed responses accumulated up to the decision point, and sequential adaptation of this allocation, could minimize the expected number of failures or maximize total benefits to patients. In this study, we developed a Bayesian response-adaptive randomization (RAR) design targeting the endpoint of organ support-free days (OSFD) for patients admitted to the intensive care units. The OSFD is a mixture of mortality and morbidity assessed by the number of days of free of organ support within a predetermined post-randomization time-window. In the past, researchers treated OSFD as an ordinal outcome variable where the lowest category is death. We propose a novel RAR design for a composite endpoint of mortality and morbidity, for example, OSFD, by using a Bayesian mixture model with a Markov chain Monte Carlo sampling to estimate the posterior probability distribution of OSFD and determine treatment allocation ratios at each interim. Simulations were conducted to compare the performance of our proposed design under various randomization rules and different alpha spending functions. The results show that our RAR design using Bayesian inference allocated more patients to the better performing arm(s) compared to other existing adaptive rules while assuring adequate power and type I error rate control across a range of plausible clinical scenarios.

Outcomes of Transcatheter Closure of Congenital Left Circumflex Coronary Artery Fistula.

BACKGROUND: Congenital left circumflex coronary artery fistula (LCX-CAF) is a relatively rare type of coronary artery fistula (CAF); little is known about the outcomes of transcatheter closure (TCC) of LCX-CAF.Methods and Results: All consecutive patients admitted to Fuwai Hospital and scheduled for TCC of LCX-CAF between January 2012 and December 2022 were reviewed retrospectively. Of the 25 consecutive patients (mean [±SD] age 34±20 years; 48% male) admitted and scheduled for TCC of congenital LCX-CAF, the procedure was feasible in 22 (77.3%). The mean (±SD) diameter of the fistulas was 6.99±2.04 mm; 21 (84%) patients had a large fistula (i.e., diameter >2-fold greater than non-feeding coronary artery). Occluders were deployed via a transarterial approach and arteriovenous loop in 6 (27.3%) and 16 (72.7%) patients, respectively. No procedural complications were recorded. Although the procedural success rates are similar for single LCX-CAF and left anterior descending CAF (81.25% vs. 92.86%; P=0.602), the mean time from initial angiography to first occluder deployment is significantly longer for LCX-CAF (83.06±36.07 vs. 36.00±9.49 min; P<0.001). The mean (±SD) follow-up time was 62.2±45.5 months. The incidence of myocardial infarction and recanalization of the fistula was 4.5% (1/22) and 9.1% (2/22), respectively. CONCLUSIONS: TCC of LCX-CAF is a feasible and effective alternative to surgical repair, with comparable outcomes in selected patients. Optimal medical therapy to prevent post-closure myocardial infarction requires further investigation.

Factors influencing senior care and living preferences among older adults in Jiangsu, China: a cross-sectional survey study.

BACKGROUND: As the population ages, senior care for older adults in China has become increasingly important and has attracted the attention of both government and society. This study aimed to explore preferences and influencing factors related to senior care among older Chinese adults and thus propose effective and targeted strategies for the development of a comprehensive care system for older adults in the aging Chinese population. METHODS: Data were obtained from a cross-sectional survey conducted in sixteen communities or villages in Jiangsu Province, China, from July to September 2021. Guided by the Andersen Behavioral Model, multivariate logistic regression was conducted to identify factors associated with preferences for senior care arrangements. RESULTS: A total of 870 respondents were included in the study, 60.11% of whom preferred receiving care in their own homes, while only 13.68% chose residential care facilities (RCFs). For predisposing factors, rural respondents preferred receiving care in their own homes compared to urban respondents (children's home: OR = 0.55, P < 0.01; RCF: OR = 0.58, P < 0.01). Concerning enabling factors, respondents who were not employed (OR = 2.30, P < 0.01) and those without financial support (OR = 2.73, P < 0.05) preferred RCFs to their own homes. Respondents receiving life assistance (sometimes: OR = 2.76, P < 0.001; regularly: OR = 2.57, P < 0.01; every day: OR = 3.57, P < 0.001) preferred their children's homes to their own homes. In terms of need factors, respondents with noncommunicable diseases (NCDs, OR > 1, P < 0.05), those who knew about RCFs (some: OR = 0.53, P < 0.005; no: OR = 0.10, P < 0.001) and those with a good impression of RCFs (fair: OR = 3.72, P < 0.05; good: OR = 11.91, P < 0.001) preferred receiving care in RCFs compared to their counterparts. CONCLUSIONS: Older Chinese adults' senior care preferences were affected by predisposing factors, enabling factors, and need factors. Policy-makers should consider targeted measures to identify more precise senior care services and thus address aging challenges in China.

Serial Measurement of Cell-Cycle Arrest Biomarkers [TIMP-2] · [IGFBP7] and Risk for Progression to Death, Dialysis, or Severe Acute Kidney Injury in Patients with Septic Shock.

Rationale: Urinary TIMP-2 (tissue inhibitor of metalloproteinases-2) and IGFBP7 (insulin-like growth factor-binding protein 7) can predict acute kidney injury (AKI) in patients with sepsis.Objectives: To address critical questions about whether biomarkers can inform the response to treatment and whether they might be used to guide therapy, as most sepsis patients present with AKI.Methods: We measured [TIMP-2] · [IGFBP7] before and after a 6-hour resuscitation in 688 patients with septic shock enrolled in the ProCESS (Protocol-based Care for Early Septic Shock) trial. Our primary endpoint was stage 3 AKI, renal replacement therapy, or death within 7 days.Measurements and Main Results: The endpoint was reached in 113 patients (16.4%). In patients with negative [TIMP-2] · [IGFBP7] at baseline, those who became positive (>0.3 U) after resuscitation had three-times higher risk compared with those who remained negative (21.8% vs. 8.5%; P = 0.01; odds ratio [OR], 3.0; 95% confidence interval [CI], 1.31-6.87). Conversely, compared with patients with a positive biomarker at baseline that were still positive at Hour 6, risk was reduced for patients who became negative (23.8% vs. 9.8%; P = 0.01; OR, 2.15; 95% CI, 1.17-3.95). A positive [TIMP-2] · [IGFBP7] after resuscitation was associated with worse outcomes in both patients with and without AKI at that time point. The clinical response to resuscitation, as judged by the Acute Physiology and Chronic Health Evaluation II score, was weakly predictive of the endpoint (area under the curve, 0.68; 95% CI, 0.62-0.73) and improved with addition of [TIMP-2] · [IGFBP7] (0.72; 95% CI, 0.66-0.77; P = 0.03). Different resuscitation protocols did not alter biomarker trajectories, nor did they alter outcomes in biomarker-positive or biomarker-negative patients. However, biomarker trajectories were associated with outcomes.Conclusions: Changes in urinary [TIMP-2] · [IGFBP7] after initial fluid resuscitation identify patients with sepsis who have differing risk for progression of AKI.Clinical trial registered with www.clinicaltrials.gov (NCT00510835).

Degradation of hydroxypropyl guar gum at wide pH range by a heterogeneous Fenton-like process using bentonite-supported Cu(0).

To seek for efficient Fenton-like oxidation processing for treatment of waste fracturing fluid containing hydroxypropyl guar gum (HPGG), in heterogeneous reaction, five bentonite-supported zero-valent metal catalysts were prepared by liquid-phase reduction. The results showed that the bentonite-supported zero-valent copper exhibited best catalytic performance, attributed to the high dispersion of active sites of zero-valent copper. The effects of the most relevant operating factors (H2O2 concentration, catalyst dosage, temperature and pH) were evaluated in detail. Moreover, the chemical oxygen demand removal rate of HPGG can achieve 76% when the reaction time was selected at 45 min under optimal experimental conditions. The stability evaluation showed that the catalytic performance was almost unaffected after the catalyst was recycled and used once more showing the good stability of the bentonite-supported zero-valent copper in the application process.

Derivation, Validation, and Potential Treatment Implications of Novel Clinical Phenotypes for Sepsis.

Importance: Sepsis is a heterogeneous syndrome. Identification of distinct clinical phenotypes may allow more precise therapy and improve care. Objective: To derive sepsis phenotypes from clinical data, determine their reproducibility and correlation with host-response biomarkers and clinical outcomes, and assess the potential causal relationship with results from randomized clinical trials (RCTs). Design, Settings, and Participants: Retrospective analysis of data sets using statistical, machine learning, and simulation tools. Phenotypes were derived among 20 189 total patients (16 552 unique patients) who met Sepsis-3 criteria within 6 hours of hospital presentation at 12 Pennsylvania hospitals (2010-2012) using consensus k means clustering applied to 29 variables. Reproducibility and correlation with biological parameters and clinical outcomes were assessed in a second database (2013-2014; n = 43 086 total patients and n = 31 160 unique patients), in a prospective cohort study of sepsis due to pneumonia (n = 583), and in 3 sepsis RCTs (n = 4737). Exposures: All clinical and laboratory variables in the electronic health record. Main Outcomes and Measures: Derived phenotype (α, ß, γ, and δ) frequency, host-response biomarkers, 28-day and 365-day mortality, and RCT simulation outputs. Results: The derivation cohort included 20 189 patients with sepsis (mean age, 64 [SD, 17] years; 10 022 [50%] male; mean maximum 24-hour Sequential Organ Failure Assessment [SOFA] score, 3.9 [SD, 2.4]). The validation cohort included 43 086 patients (mean age, 67 [SD, 17] years; 21 993 [51%] male; mean maximum 24-hour SOFA score, 3.6 [SD, 2.0]). Of the 4 derived phenotypes, the α phenotype was the most common (n = 6625; 33%) and included patients with the lowest administration of a vasopressor; in the ß phenotype (n = 5512; 27%), patients were older and had more chronic illness and renal dysfunction; in the γ phenotype (n = 5385; 27%), patients had more inflammation and pulmonary dysfunction; and in the δ phenotype (n = 2667; 13%), patients had more liver dysfunction and septic shock. Phenotype distributions were similar in the validation cohort. There were consistent differences in biomarker patterns by phenotype. In the derivation cohort, cumulative 28-day mortality was 287 deaths of 5691 unique patients (5%) for the α phenotype; 561 of 4420 (13%) for the ß phenotype; 1031 of 4318 (24%) for the γ phenotype; and 897 of 2223 (40%) for the δ phenotype. Across all cohorts and trials, 28-day and 365-day mortality were highest among the δ phenotype vs the other 3 phenotypes (P < .001). In simulation models, the proportion of RCTs reporting benefit, harm, or no effect changed considerably (eg, varying the phenotype frequencies within an RCT of early goal-directed therapy changed the results from >33% chance of benefit to >60% chance of harm). Conclusions and Relevance: In this retrospective analysis of data sets from patients with sepsis, 4 clinical phenotypes were identified that correlated with host-response patterns and clinical outcomes, and simulations suggested these phenotypes may help in understanding heterogeneity of treatment effects. Further research is needed to determine the utility of these phenotypes in clinical care and for informing trial design and interpretation.

Changes in inflammatory endometrial cancer risk biomarkers in individuals undergoing surgical weight loss.

OBJECTIVE: Obesity has been strongly linked to endometrial cancer (EC) risk. A number of potential EC risk biomarkers have been proposed, including heightened pro-inflammatory cytokines and adipokines. To evaluate if bariatric surgery can serve as a means for altering levels of such EC risk biomarkers, we investigated changes in these biomarkers after weight loss. METHODS: Blood samples were collected pre-operatively and 6months post-operatively in 107 female bariatric surgery patients aged 18-72years. Wilcoxon signed-rank tests were used to compare biomarker levels (measured using xMAP immunoassays) pre- and post-surgery. Normative comparisons were implemented to contrast 6-month post-surgery biomarker levels to levels in a sample of 74 age-matched non-obese women. Linear regression was used to evaluate the relationship between biomarker expression at baseline and 6months post-surgery and the relationship between race and biomarker levels. RESULTS: On average, participants lost 30.15kg (SD: 12.26) after the bariatric intervention. Levels of C-peptide, insulin, CRP, leptin, IL-1Rα, and IL-6 significantly decreased, while levels of SHBG, IGFBP1, and adiponectin significantly increased with weight loss. Normative comparisons showed the levels of SHBG, C-peptide, insulin, IGFBP1, adiponectin, CRP, and TNFα after bariatric intervention approached the level of markers in comparison group. Multiple regression analyses revealed significant relationships between changes in BMI and changes in biomarker levels. The changes in IL-1Rα were significantly associated with race. CONCLUSIONS: Our findings demonstrate that normalization of EC risk biomarkers can be achieved with bariatric surgery. Improved understanding of biological mechanisms associated with weight loss may inform preventive strategies for EC.

Transcatheter occlusion of azygos/hemiazygos vein in patients with systemic venous collateral development after the bidirectional Glenn procedure.

OBJECTIVES: To elucidate the feasibility and treatment effects of transcatheter occlusion of the azygos/hemiazygos vein in patients with progressive cyanosis after performing the bidirectional Glenn procedure. METHODS: From January 2007 to May 2011, transcatheter closure was performed on 9 patients (7 males and 2 females) aged 5-15 years (median 9 years). RESULTS: A total of 7 azygos veins and 3 hemiazygos veins were occluded successfully. Coils were employed in 4 of the procedures, patent ductus arteriosus (PDA) occluders in 3, atrial septal defect occluders in 2 and a PDA occluder together with coils in 1 procedure. Immediate complete occlusions were achieved in 9 (81.8%) procedures and trivial residual shunt in 2 (18.2%). The femoral artery oxygen saturation (SaO2) rose from 81 [interquartile range (IQR) 75-86%] to 88% (IQR 84-91%). CONCLUSIONS: Patients with superior vena cava azygos vein collateral channels can be treated successfully by transcatheter occlusion with multiple devices. The device for embolization depends on the extent of the severity of the shunt, the size of the lumen of the azygos vein/hemiazygos vein and the candidate location for occlusion.

Transcatheter closure of coronary artery fistulae: initial human experience with the Amplatzer Duct Occluder II.

OBJECTIVES: To evaluate the efficacy and safety of the new device Amplatzer Duct Occluder II (ADO II) for the closure of coronary artery fistulae (CAF) with coronary anomaly. BACKGROUND: Transcatheter device closure is an alternative treatment for selective patients with CAF. The currently available reports regarding the closure of CAF with the ADO II are limited. METHODS: From April 1, 2011 to July 15, 2012, 5 patients (3 males and 2 females) aged from 3 years to 27 years old (median age 5 years old) underwent CAF closure with the ADO II. The immediate and short-term outcomes were evaluated. RESULTS: ADO II was deployed via the femoral vein (2 cases), femoral artery (1 case), brachial artery (1 case), and radial artery (1 case). There were no complications during all the procedures. The median fluoroscopy and procedural times were 20 and 39 minutes, respectively. Immediate trivial and mild residual shunt was present in one patient, respectively, but disappeared 24 hours after the procedure, and there was no recanalization at a median follow-up of 6 months. CONCLUSIONS: The new device ADO II was safely deployed with complete resolution of CAF shunt with tortuous coronary artery to the drainage. The reduced sheath sizes and softer shape of this device allow for venous or arterial approach. The ADO II might be a preferable alternative device for closure of small-tortuous CAFs.

Interventional Occlusion of Large Patent Ductus Arteriosus in Adults with Severe Pulmonary Hypertension.

(1) Background: the indications for transcatheter closure of large patent ductus arteriosus (PDA) with severe pulmonary hypertension (PH) are still unclear, and scholars have not fully elucidated the factors that affect PH prognosis. (2) Methods: we retrospectively enrolled 134 consecutive patients with a PDA diameter ≥10 mm or a ratio of PDA and aortic >0.5. We collected clinical data to explore the factors affecting follow-up PH. (3) Results: 134 patients (mean age 35.04 ± 10.23 years; 98 women) successfully underwent a transcatheter closure, and all patients had a mean pulmonary artery pressure (mPAP) >50 mmHg. Five procedures were deemed to have failed because their mPAP did not decrease, and the patients experienced uncomfortable symptoms after the trial occlusion. The average occluder (pulmonary end) size was almost twice the PDA diameter (22.33 ± 4.81 mm vs. 11.69 ± 2.18 mm). Left ventricular end-diastolic dimension (LVEDD), mPAP, and left ventricular ejection fraction (LVEF) significantly reduced after the occlusion, and LVEF recovered during the follow-up period. In total, 42 of the 78 patients with total pulmonary resistance >4 Wood Units experienced clinical outcomes, and all of them had PH in the follow-up, while 10 of them had heart failure, and 4 were hospitalized again because of PH. The results of a logistic regression analysis revealed that the postoperative mPAP had an independent risk factor (odds ratio = 1.069, 95% confidence interval: 1.003 to 1.140, p = 0.040) with a receiver operating characteristic curve cut-off value of 35.5 mmHg (p < 0.001). (4) Conclusions: performing a transcatheter closure of large patent ductus arteriosus is feasible, and postoperative mPAP was a risk factor that affected the follow-up PH. Patients with a postoperative mPAP >35.5 mmHg should be considered for targeted medical therapy or should undergo right heart catheterization again after the occlusion.

Outcomes following transcatheter closure or surgical repair of coronary-left ventricular fistula: A single-center study with 10-year experience.

BACKGROUND: Coronary arteries drain into the left ventricle, known as coronary-left ventricular fistula (CLVF), an extremely rare anomalous coronary artery disease. Little is known about the outcomes following transcatheter closure (TC) or surgical closure (SC) of CLVF. METHOD: This was a single-center retrospective study including 42 consecutive patients who underwent either the TC or SC procedure from January 2011 to December 2021. The baseline and anatomic characteristics of the fistulas, procedural outcomes, and late outcomes were summarized and analyzed. RESULTS: The mean age was 31.6 ± 16.2 years, with 28 male patients (66.7%). Fifteen patients underwent SC group and the remaining received TC group. There were no differences in age, comorbidities, clinical presentations, and anatomic characteristics between the 2 groups. The procedural success rate was similar (93.3% vs. 85.2%, P = 0.639) without operative and in-hospital mortality in both groups. Notably, patients who underwent TC had a significantly shorter postoperative in-hospital length of stay (2.11 ± 1.49 vs. 7.73 ± 2.37 days, P<0.001). The median follow-up time was 4.6 years (2.5-5.7 years, TC group) and 3.98 years (0.42-7.15 years, SC group), respectively. No difference was observed in the incidence of recanalization of the fistula (7.4% vs. 6.7%, P = 1) and myocardial infarction (0% vs. 0%). Cerebral infarction due to discontinuation of anticoagulants happened to two patients in the TC group. Importantly, thrombotic occlusion of the fistulous tract with patent parent coronary artery was found in 7 patients of the TC group. CONCLUSION: Both transcatheter and SC are safe and effective for patients with CLVF. Thrombotic occlusion is a noteworthy late complication, and its presence indicates the use of anticoagulants lifelong.

Transcatheter closure of inferior sinus venosus defect using a patent ductus arteriosus occluder following simulation with a 3D-printed model.

Background: Transcatheter closure of inferior sinus venosus defect (ISVD) is still contraindication. To explore whether transcatheter closure with patent ductus arteriosus (PDA) occluders is possible for ISVD. Methods: From June 2014 to March 2021, 12 patients were recruited diagnosed as <25 mm ISVD. The three-dimensional printing (3DP) heart model was produced based on multi-slice computed tomography (MSCT) scans. Preoperative closure simulation was planned on the personalized 3D model for each patient. Follow-up including electrocardiography (ECG), transthoracic echocardiography (TTE), and X-ray was traced. Results: 3DP models of 12 patients were successfully printed. Twelve patients had been diagnosed with <25 mm ISVD and 4 of them had another secundum atrial septal defect (ASD). All patients were produced interventional therapy successfully. PDA occluder was implanted to closed ISVD, and ASD was closed using ASD occluder simultaneously. The average diameter of ISVD measured by TTE was (12.67±3.80), and the average diameter of sagittal axes and longitudinal axes measured by the 3D-printed model was (17.08±3.20) and (18.42±4.62) mm, respectively. The average size of PDA (diameter of pulmonary artery side) was (28.17±3.35) mm. Compared with the preoperative, the X-ray cardiothoracic ratio (0.51±0.04 vs. 0.47±0.06, P=0.007) and the right ventricle anterior-posterior diameter (31.17±5.65 vs. 24.58±3.75 mm, P<0.001) of postoperative was significantly decreased. During the average (47.75±27.52) months follow-up, it has achieved satisfying results, and there were no severe adverse events such as device transposition, death, and pericardial tamponade occurred. Conclusions: Assisting by 3D heart model, transcatheter closure of ISVD with PDA occluder had an excellent outcome. This method provides a new considerable treatment strategy for ISVD.

[Value of cardiac CT examination in middle-aged and elderly patients with atrial septal defect before planned transcatheter closure].

OBJECTIVE: To investigate the value of the cardiac CT examination for decision making in middle-aged and elderly patients before planned transcatheter atrial septal defect (ASD) closure. METHODS: Cardiac CT was performed in 63 adult patients [18 males, aged from 50 to 77 years, mean age (56.87 ± 5.79) years] with ASD before planned transcatheter ASD closure. Coronary CT angiography was made for detection of associated cardiovascular diseases, followed by 3D reconstruction of ASD for determination of the defect size in the GE-workstation, results were compared between transthoracic echocardiography measurement, CT measurement, and atrial septal defect occluder waist diameter. RESULTS: Cardiac CT identified additional cardiovascular diseases in 14 patients and decision making was changed based on cardiac CT results. Coronary artery stenosis was detected in 8 patients by cardiac CT, and proved by coronary angiography, and all of them were given comprehensive management: percutaneous coronary intervention and transcatheter ASD closure were successively performed in 2 cases, and 1 case was referred to surgery for both coronary artery bypass graft and surgical ASD repair, and 5 patients were given pharmacological management for coronary artery disease besides transcatheter ASD closure. Cardiac CT identified large ASD with insufficient rim tissue in 2 cases and transcatheter closures were abandoned. Cardiac CT screened out 1 case from those with insufficient posterior inferior rim by transthoracic echocardiography, and transcatheter ASD closure was successfully performed. Cardiac CT ruled out ASD in 1 patient. In addition, cardiac CT detected 1 partial abnormal pulmonary vein connection and 1 ductus arteriosus in this cohort. A correlation on ASD measurements was found between CT size and TTE size (r = 0.80, P < 0.01; Y = 0.84X + 8.85, R(2) = 0.63, P < 0.05), and between ASO size and CT size (r = 0.92, P < 0.01;Y = 0.93X + 4.78, R(2) = 0.84, P < 0.05). CONCLUSION: In middle-aged and elderly patients with ASD for possible transcatheter closure, cardiac CT is valuable on determine ASD size and morphology and could provide incremental information for optimizing clinical management for ASD patients.

Detecting survival-associated biomarkers from heterogeneous populations.

Detection of prognostic factors associated with patients' survival outcome helps gain insights into a disease and guide treatment decisions. The rapid advancement of high-throughput technologies has yielded plentiful genomic biomarkers as candidate prognostic factors, but most are of limited use in clinical application. As the price of the technology drops over time, many genomic studies are conducted to explore a common scientific question in different cohorts to identify more reproducible and credible biomarkers. However, new challenges arise from heterogeneity in study populations and designs when jointly analyzing the multiple studies. For example, patients from different cohorts show different demographic characteristics and risk profiles. Existing high-dimensional variable selection methods for survival analysis, however, are restricted to single study analysis. We propose a novel Cox model based two-stage variable selection method called "Cox-TOTEM" to detect survival-associated biomarkers common in multiple genomic studies. Simulations showed our method greatly improved the sensitivity of variable selection as compared to the separate applications of existing methods to each study, especially when the signals are weak or when the studies are heterogeneous. An application of our method to TCGA transcriptomic data identified essential survival associated genes related to the common disease mechanism of five Pan-Gynecologic cancers.

Transcatheter Closure of Patent Ductus Arteriosus via Different Approaches.

Background: There have been marked advances in devices such as Amplatzer Duct Occluder II (ADO-II) or vascular plug through 5Fr delivery sheath for closure of patent ductus arteriosus (PDA) in the past five decades, making it possible for cardiologists to deliver occluders via different approaches. However, comparisons of these different approaches have not been reported. Therefore, the aim of this study was to summarize and compare the advantages of different approaches for PDA closure, and to guide clinical strategies. Methods: This retrospective study included all patients undergoing transcatheter closure of PDA from 2019 to 2020. Patients were matched by 1:1 propensity score matching (PSM). The retrograde femoral artery approach (FAA) and simple vein approach (SVA) groups were compared with the conventional arteriovenous approach (CAA). Results: The average age of the 476 patients was 21.05 ± 21.15 years. Their average weight was 38.23 ± 24.1 kg and average height was 130.14 ± 34.45 cm. The mean diameter of the PDA was 4.29 ± 2.25 mm. There were 127 men and 349 women, comprising 205 adults and 271 children. Among them, 197 patients underwent CAA, 223 underwent SVA, and 56 underwent retrograde FAA. The diameter in the FAA group was smaller than that in the other two groups, but was similar in adults and children. In the PSM comparison of CAA and SVA, 136 patients with CAA and 136 patients with SVA were recruited. Simple vein approach was associated with markedly reduced length of hospital stay, length of operation, and contrast medium usage as compared with CAA (all P < 0.05). In the PSM comparison of FAA and CAA, 30 patients with CAA and 30 patients with FAA were recruited. The operation duration was longer in the CAA than in the FAA group. There were no significant differences in postoperative complications among groups. Conclusion: Patent ductus arteriosus closure by using the SVA and FAA is safe and effective, and has certain advantages in some respects as compared with CAA.

Transbrachial Access for Transcatheter Closure of Paravalvular Leak Following Prosthetic Valve Replacement.

Background: Transcatheter closure of paravalvular leak (PVL) has evolved into an alternative to surgery in high-risk patients. In this study, we introduce a new access for transcatheter closure of PVL and seek to evaluate the feasibility and safety of this access. Methods: We retrospectively analyzed patients undergoing transbrachial access for transcatheter mitral or aortic PVL closure (August 2017-November 2019) at our hospital. All patients underwent puncture of the brachial artery under local anesthesia. Results: The study population included 11 patients, with an average age of 55.91 ± 14.82 years. Ten out of 11 patients were successfully implanted with devices via the brachial artery approach, and one patient was converted to the transseptal approach. The technical success rate of transbrachial access was 90.9%. Mean NYHA functional class improved from 3.1 ± 0.5 before the procedure to 1.9 ± 0.5 after PVL closure. Severe paravalvular regurgitation (PVR) in five patients and moderate PVR in six patients prior to the procedure were significantly reduced to mild in four patients and none in seven patients after the procedure. Complications included one case of pseudoaneurysm and one case of moderate hemolysis aggravation after closure. One patient had an unknown cause of sudden death within 24 h after the procedure. The half-year mortality rate during follow-up was 9.1% (1/11). Conclusions: Transbrachial access for transcatheter closure of PVL may be a feasible and safe treatment and should include well-selected patients. It has several potential advantages of simplifying the procedure process and reducing postprocedural bed rest time.

[Clinical and angiographic characteristics of mid-ventricular hypertrophic obstructive cardiomyopathy].

OBJECTIVE: To analyze the clinical and angiographic characteristics of mid-ventricular hypertrophic obstructive cardiomyopathy (MV-HOCM). METHODS: MV-HOCM was diagnosed in 5 patients [3 males, mean age: 16 - 73 (44 ± 22) years]. Left ventricular catheterization and angiography were performed in all patients, and the pressures were recorded in the left ventricular apical chamber, basal chamber, outflow tract and ascending aorta. RESULTS: Of five patients with MV-HOCM, chest discomfort occurred in four patients and syncope in two patients. All patients presented systolic murmur and asymmetric left ventricular hypertrophy. The thickness of ventricular septum was 19 - 31 (23.8 ± 5.4) mm, the dimension of left ventricle was 35 - 55 (43.4 ± 7.4) mm and the LVEF was 53% - 70% (64.2% ± 6.9%). Electrocardiogram showed left ventricular hypertrophy with Q waves in all patients, ventricular tachycardia in 1 patient and complete left bundle branch block in 1 patient. Mid-ventricular obstruction was found in all patients and the pressure gradient in mid-ventricle was 45 - 102 (68.6 ± 24.1) mm Hg (1 mm Hg = 0.133 kPa). Coronary angiogram documented muscular bridge presented in 1 patient and coronary artery disease in 1 patient. Left ventricular apical aneurysm was seen in 2 patients. CONCLUSION: MV-HOCM was a distinguished subtype of hypertrophic obstructive cardiomyopathy, and left cardiac catheterization and angiography examinations are necessary for confirming diagnosis and guiding related therapy.

[Angiocardiographic characteristics of patients post bidirectional Glenn procedure].

OBJECTIVE: The study was performed to observe the angiocardiographic characteristics of patients post bidirectional Glenn procedure. METHODS: Thirty-eight consecutive patients [24 male/14 female, age 0.9 - 28 (7.8 ± 5.6) years] underwent bidirectional Glenn procedure were included in this study. Postoperative cardiac catheterization and angiocardiography were performed at 2 - 7 (4.1 ± 1.9) years after bidirectional Glenn procedure. RESULTS: Of 38 patients, pulmonary arterial mean pressure (PAMP) was (14.8 ± 4.5) mm Hg (1 mm Hg = 0.133 kPa), the mean pressure of superior vena cava (MPSVC) was (15.4 ± 5.4) mm Hg and no pressure gradient was detected. Elevated pulmonary arterial pressure was evidenced in 9 patients: PAMP was (21.5 ± 2.9) mm Hg and MPSVC was (22.9 ± 5.1) mm Hg. Systemic venous collateral channels (SVCC) were shown in 14 patients and PAMP [(16.7 ± 5.7) mm Hg vs. (13.7 ± 3.4) mm Hg, P < 0.05] and MPSVC [(17.8 ± 7.2) mm Hg vs. (14.0 ± 3.6) mm Hg, P < 0.05] were higher in SVCC patients compared to patients without SVCC. Transcatheter closure was successfully performed in 2 patients. Distribution of SVCC was as follows: Posterior SVCC in 12 patients (associated anterior SVCC in 3 patients and middle SVCC in 1 patient), middle SVCC in 2 patients. Pulmonary arteriovenous fistulae were presented in 2 patients. Aortopulmonary collateral arteries were presented in another 2 patients and were successfully occluded percutaneously. CONCLUSION: Catheterization and angiocardiography play an important role in recognizing the complications post bidirectional Glenn procedure.

[Fibrinolytic therapy for femoral artery thrombosis after left cardiac catheterization in children].

OBJECTIVE: The study was conducted to investigate the feasibility and effectiveness of fibrinolytic therapy for femoral artery thrombosis after left cardiac catheterization in children. METHODS: Thrombolytic therapy with urokinase was applied in 16 children (5 males) with femoral artery thrombosis after left cardiac catheterization. Patients were given a bolus injection of heparin, 100 U/kg. 30,000-100,000 U boluses of urokinase were injected intravenously, and then a continuous infusion of 10,000-50,000 U/h was started. Transcatheter thrombolysis was performed once previous procedures failed. RESULTS: All 16 patients presented lower limbs ischemia after left cardiac catheterizations. The age was (2.6 +/- 1.9) years, the height was (85.3 +/- 13.1) cm, the weight was (11.2 +/- 3.8) kg. Patients with cyanotic and acyanotic congenital heart disease were 2 and 14, respectively. Interventional therapy was performed in 12 patients. Absent arterial pulsations were found in 15 patients and reduced arterial pulsation in 1 patient. Femoral arterial perfusion became normal in all patients (3 after transcatheter thrombolysis, 11 post intravenous thrombolysis and 2 post intravenous heparin). The average doses of heparin and urokinase were (950 +/- 682) U and (295,357 +/- 198,770) U. The average duration of therapy was (7.25 +/- 5.31) h. Mild residual stenosis were found in 2 patients post various treatments. CONCLUSION: Fibrinolytic therapy with urokinase is a safe and useful modality for children with femoral artery thrombosis after left cardiac catheterization.