Development of a machine learning-based model to predict major adverse events after surgery for type A aortic dissection complicated by malnutrition.

Objective: This study aims to develop a predictive model for the risk of major adverse events (MAEs) in type A aortic dissection (AAAD) patients with malnutrition after surgery, utilizing machine learning (ML) algorithms. Methods: We retrospectively collected clinical data from AAAD patients with malnutrition who underwent surgical treatment at our center. Through least absolute shrinkage and selection operator (LASSO) regression analysis, we screened for preoperative and intraoperative characteristic variables. Based on the random forest (RF) algorithm, we constructed a ML predictive model, and further evaluated and interpreted this model. Results: Through LASSO regression analysis and univariate analysis, we ultimately selected seven feature variables for modeling. After comparing six different ML models, we confirmed that the RF model demonstrated the best predictive performance in this dataset. Subsequently, we constructed a model using the RF algorithm to predict the risk of postoperative MAEs in AAAD patients with malnutrition. The test set results indicated that this model has excellent predictive efficacy and clinical applicability. Finally, we employed the Shapley additive explanations (SHAP) method to further interpret the predictions of this model. Conclusion: We have successfully constructed a risk prediction model for postoperative MAEs in AAAD patients with malnutrition using the RF algorithm, and we have interpreted the model through the SHAP method. This model aids clinicians in early identification of high-risk patients for MAEs, thereby potentially mitigating adverse clinical outcomes associated with malnutrition.

Procedural volume and outcomes with atrial fibrillation ablation: A report from the NCDR AFib Ablation Registry.

BACKGROUND: The association of hospital and physician procedure volume with outcome has not been well evaluated for atrial fibrillation (AF) ablation in contemporary practice. OBJECTIVE: This study aimed to determine the association between hospital and physician AF ablation volume and procedural success (isolation of all pulmonary veins) and major adverse events (MAEs). METHODS: Procedures reported to the National Cardiovascular Data Registry AFib Ablation Registry between July 2019 and June 2022 were included. Hospital and physician procedural volumes were annualized and stratified into quartiles to compare outcomes. Three-level hierarchical (patient, hospital, and physician) models were used to assess the procedural volume-outcome relationship. RESULTS: A total of 70,296 first-time AF ablations at 186 US hospitals were included. Overall, procedural success and MAE rates were 98.5% and 1.0%, respectively. With hospital volume (Q4) as a reference, the likelihood of procedural success was lower for Q1 (odds ratio [OR], 0.44; 95% CI, 0.29-0.68), Q2 (OR, 0.50; 95% CI, 0.33-0.75), and Q3 (OR, 0.60; 95% CI, 0.40-0.89); the results were similarly significant for physician volume. With MAE for hospitals, there was an inverse procedural volume relationship for Q1 (OR, 1.78; 95% CI, 1.26-2.52) but not for Q2 (OR, 1.06; 95% CI, 0.77-1.46) or Q3 (OR, 1.19; 95% CI, 0.89-1.58) and similarly for physicians in Q1 and Q2 but not in Q3. An adjusted MAE ≤1% was predicted by an annual volume of approximately 190 for hospitals and 60 for physicians. CONCLUSION: In this national cohort, hospital and physician AF ablation procedural volumes were directly related to acute procedural success and inversely related to rates of MAE.

How Good Are Cardiologists at Predicting Major Adverse Events in Fontan Patients?

Background: It is unknown how well cardiologists predict which Fontan patients are at risk for major adverse events (MAEs). Objectives: The purpose of this study was to examine the accuracy of cardiologists' ability to identify the "good Fontan" patient, free from MAE within the following year, and compare that predicted risk cohort to patients who experienced MAE. Methods: This prospective, multicenter study included patients ≥10 years with lateral tunnel or extracardiac Fontan. The cardiologist was asked the yes/no "surprise" question: would you be surprised if your patient has a MAE in the next year? After 12 months, the cardiologist was surveyed to assess MAE. Agreement between cardiologist predictions of MAE and observed MAE was determined using the simple kappa coefficient. Multivariable generalized linear mixed effects models were performed to identify factors associated with MAE. Results: Overall, 146 patients were enrolled, and 99/146 (68%) patients w`ere predicted to be a "good Fontan." After 12 months, 17 (12%) experienced a MAE. The simple kappa coefficient of cardiologists' prediction was 0.17 (95% CI: 0.02-0.32), suggesting prediction of MAE was 17% better than random chance. In the multivariable cardiologist-predicted MAE (N = 47) model, diuretic/beta-blocker use (P ≤ 0.001) and systolic dysfunction (P = 0.005) were associated with MAE. In the observed multivariable MAE (N = 17) model, prior unplanned cardiac admission (P = 0.006), diuretic/beta-blocker use (P = 0.028), and ≥moderate atrioventricular valve regurgitation (P = 0.049) were associated with MAE. Conclusions: Cardiologists are marginally able to predict which Fontan patients are at risk for MAE over a year. There was overlap between factors associated with a cardiologist's prediction of risk and observed MAE, namely the use of diuretic/beta-blocker.

The prognostic value of preoperative systemic inflammatory response index in predicting outcomes of acute type A aortic dissection patients underwent surgical treatment.

Background: The systemic inflammatory response index (SIRI) is a novel inflammatory-immune biological marker that has prognostic value in various cardiovascular diseases. This study aims to investigate the relationship between SIRI and short-term and long-term prognosis in patients with acute type A aortic dissection (AAAD) underwent surgical treatment. Methods: We conducted a retrospective analysis of patients with AAAD who underwent emergency surgical treatment at our center. Through multifactorial logistics regression analysis and cox proportional hazards regression analysis, we identified SIRI as an independent risk factor for major adverse events (MAEs) and long-term aorta-related adverse events (ARAEs) post-surgery. The optimal cutoff value of preoperative SIRI was determined using receiver operating characteristic (ROC) curve analysis, and patients were divided into low SIRI group and high SIRI group. The prognostic outcomes at different time points post-surgery for the two groups of patients were analyzed using Kaplan-Meier survival analysis, and the significance was determined by log-rank test. Results: A total of 691 AAAD patients were included in this study. Among them, 50 patients (7.2%) died within 30 days post-surgery, and 175 patients (25.3%) experienced MAEs. A total of 641 patients were followed up, with an average follow-up time of 33.5 ± 17.5 months, during which 113 patients (17.6%) experienced ARAEs. The results of multifactorial logistics regression analysis and cox proportional hazards regression analysis showed that SIRI was an independent risk factor for postoperative MAEs (OR=3.148, 95%CI[1.650-6.006], p<0.001) and ARAEs (HR=2.248, 95%CI[1.050-4.809], p<0.037). Kaplan-Meier analysis demonstrated that the MAEs-free survival in the high SIRI group was significantly lower than that in the low SIRI group, and a similar trend was observed in the ARAEs-free survival during follow-up (log-rank test, p<0.001). Conclusion: Preoperative SIRI is significantly associated with the short-term and long-term prognosis of AAAD patients underwent emergency open surgery, demonstrating its valuable prognostic value. Therefore, preoperative SIRI is a reliable biological marker that can serve as a valuable tool for preoperative risk stratification and decision management.

Cardioprotective effects of high-altitude adaptation in cardiac surgical patients: a retrospective cohort study with propensity score matching.

Background: The cardioprotective effect of remote ischemia preconditioning in clinical studies is inconsistent with experimental results. Adaptation to high-altitude hypoxia has been reported to be cardioprotective in animal experiments. However, the clinical significance of the cardioprotective effect of high-altitude adaptation has not been demonstrated. Methods: A retrospective cohort study with propensity score matching was designed to compare the outcomes of cardiac surgery between highlanders and lowlanders in a tertiary teaching hospital. The data of adult cardiac surgical patients from January 2013 to December 2022, were collected for analysis. Patients with cardiopulmonary bypass and cardioplegia were divided into a low-altitude group (<1,500 m) and a high-altitude group (≥1,500 m) based on the altitude of their place of residence. Results: Of 3,020 patients, the majority (87.5%) permanently lived in low-altitude regions [495 (435, 688) m], and there were 379 patients (12.5%) in the high-altitude group [2,552 (1,862, 3,478) m]. The 377 highlander patients were matched with lowlander patients at a ratio of 1:1. The high-altitude group exhibited a 44.5% reduction in the incidence of major adverse cardiovascular events (MACEs) compared with the low-altitude group (6.6% vs. 11.9%, P = 0.017). The patients in the moderate high-altitude subgroup (2,500-3,500 m) had the lowest incidence (5.6%) of MACEs among the subgroups. The level of creatinine kinase muscle-brain isoenzymes on the first postoperative morning was lower in the high-altitude group than in the low-altitude group (66.5 [47.9, 89.0] U/L vs. 69.5 [49.3, 96.8] U/L, P = 0.003). Conclusions: High-altitude adaptation exhibits clinically significant cardioprotection in cardiac surgical patients.

Early and midterm outcomes of fenestrated and branched endovascular aortic repair in thoracoabdominal aneurysms types I through III.

BACKGROUND: Fenestrated and branched endovascular aortic repair (F/BEVAR) of thoracoabdominal aortic aneurysms (TAAAs) has shown high technical success and low early mortality rates. Aneurysm extent has been reported as a factor affecting outcomes. This study aimed to assess the early and midterm follow-up outcomes of patients managed by F/BEVAR for types I through III TAAAs. METHODS: A single-center retrospective analysis was conducted, including data from consecutive, elective and urgent (symptomatic and ruptured cases), patients treated for types I through III TAAAs, between October 1, 2011, and October 1, 2022, using F/BEVAR. Degenerative and postdissection TAAAs were included. Patients received prophylactic cerebrospinal fluid drainage (CSFD), except those under therapeutic anticoagulation, those who were hemodynamically unstable, or those with failed CSFD application. When an initial thoracic endovascular aortic repair was performed, as part of a staged procedure, no CSFD was used. Later stages and nonstaged procedures were performed under CSFD. Thirty-day mortality and major adverse events (MAEs) were analyzed. Kaplan-Meier estimates were used for follow-up outcomes. RESULTS: F/BEVAR for types I through III TAAAs was performed in 209 patients (56.9% males; mean age, 69.6 ± 3.2 years; mean aneurysm diameter, 65.2 ± 6.2 mm); 29.2% type I, 57.9% type II, and 12.9% type III. Urgent repair was performed in 26.7% of patients (56 cases; 23 ruptured and 33 symptomatic cases) and 153 were treated electively. Thirty-two patients (15.3%) were classified as American Society of Anesthesiologists (ASA) class IV. CSFD was used in 91% and staged thoracic endovascular aortic repair was performed in 51.2% of patients. Technical success was 93.8% (96.7% in elective vs 94.6% in urgent cases; P = .92). Thirty-day mortality was 11.0% (4.6% in elective vs 28.5% in urgent cases; P < .001) and MAEs were recorded in 17.2% of cases (7.8% in elective vs 42.8% in urgent cases; P < .001). Spinal cord ischemia rate was 20.5% (17.6% in elective vs 28.7% in urgent cases; P = .08), whereas 2.9% of patients presented paraplegia (1.3% in elective and 7.1% in urgent cases; P = .03). The mean follow-up was 16 ± 5 months. Survival was 75.0% (standard error, 4.0%) and freedom from reintervention was 73.3% (standard error, 4.4%) at 36 months. ASA IV and urgent repair were detected as independent factors related to early mortality and MAE, whereas ruptured aneurysm status was related to spinal cord ischemia evolution. CONCLUSIONS: Endovascular repair for types I through III TAAAs provides encouraging early outcomes in terms of mortality, MAE, and paraplegia, especially in an elective setting. Setting of repair and baseline ASA score should be taken into consideration during decision-making.

Efficacy of intravascular lithotripsy (IVL) in coronary stenosis with severe calcification: A multicenter systematic review and meta-analysis.

BACKGROUND: With heavily calcified coronary and peripheral artery lesions, lesion preparation is crucial before stent placement to avoid underexpansion, associated with stent thrombosis or restenosis and patency failure in the long-term. Intravascular lithotripsy (IVL) technology disrupts superficial and deep calcium by using localized pulsative sonic pressure waves, making it to a promising tool for patients with severe calcification in coronary bed. AIMS: The aim of the study is to systematically review and summarize available data regarding the safety and efficacy of IVL for lesion preparation in severely calcified coronary arteries before stenting. METHODS: This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL before stent implantation. The diameter of the vessel lumen before and after IVL, as well as stent implantation, were analyzed. The occurrence of major adverse cardiovascular events (MACE) was assessed using a random-effects model. RESULTS: This meta-analysis comprised 38 studies including 2977 patients with heavily calcified coronary lesions. The mean age was 72.2 ± 9.1 years, with an overall IVL clinical success of 93% (95% confidence interval [CI]: 91%-95%, I2 = 0%) and procedural success rate of 97% (95% CI: 95%-98%, I2 = 73.7%), while the in-hospital and 30-days incidence of MACE, myocardial infarction (MI), and death were 8% (95% CI: 6%-11%, I2 = 84.5%), 5% (95% CI: 2%-8%, I2 = 85.6%), and 2% (95% CI: 1%-3%, I2 = 69.3%), respectively. There was a significant increase in the vessel diameter (standardized mean difference [SMD]: 2.47, 95% CI: 1.77-3.17, I2 = 96%) and a decrease in diameter stenosis (SMD: -3.44, 95% CI: -4.36 to -2.52, I2 = 97.5%) immediately after IVL application, while it was observed further reduction in diameter stenosis (SMD: -6.57, 95% CI: -7.43 to -5.72, I2 = 95.8%) and increase in the vessel diameter (SMD: 4.37, 95% CI: 3.63-5.12, I2 = 96.7%) and the calculated lumen area (SMD: 3.23, 95% CI: 2.10-4.37, I2 = 98%), after stent implantation. The mean acute luminal gain following IVL and stent implantation was estimated to be 1.27 ± 0.6 and 1.94 ± 1.1 mm, respectively. Periprocedural complications were rare, with just a few cases of perforations, dissection, or no-reflow phenomena recorded. CONCLUSIONS: IVL seems to be a safe and effective strategy for lesion preparation in severely calcified lesions before stent implantation in coronary arteries. Future prospective studies are now warranted to compare IVL to other lesion preparation strategies.

Transcatheter tricuspid valve replacement for functional tricuspid regurgitation after left-sided valve surgery: A single-center experience.

BACKGROUND: Functional tricuspid regurgitation (FTR) following left-sided valve surgery (LSVS) is of clinical significance due to its high recurrence and mortality rates. Transcatheter therapy presents a potential solution to address this issue. AIMS: The study aimed to assess the safety and efficacy of transcatheter tricuspid valve replacement using the Lux-Valve system in a single center for patients with FTR after LSVS. METHODS: From June 2020 to April 2023, 20 patients with symptomatic severe FTR after LSVS were referred to our center. A multidisciplinary cardiac team evaluated these patients for suitability for transcatheter tricuspid valve replacement with Lux-Valve systems. Primary efficacy and safety endpoints were immediate postoperative tricuspid regurgitation severity ≤ moderate and major adverse events during follow-up. RESULTS: Twenty patients (average age 65.7 ± 7.4 years; 65.0% women) successfully underwent Lux-Valve system implantation after LSVS. All patients achieved ≤ moderate tricuspid regurgitation immediately after the procedure. Only one patient (5.0%) experienced a procedure-related major adverse event, leading to in-hospital mortality due to pulmonary infection. At the 6-month follow-up, 17 patients (89.5%) improved to New York Heart Association functional class I to II (p < 0.001). The overall Kansas City Cardiomyopathy Questionnaire score significantly improved (35.9 ± 6.7 points to 58.9 ± 5.8 points, p < 0.001). CONCLUSION: The Lux-Valve system was found to be safe and effective for treating FTR after LSVS. It resulted in positive early outcomes, including a significant reduction in FTR, improved functional status, and enhanced quality of life, especially in high-risk patients.

Outcomes of post-implantation syndrome after endovascular repair for Stanford type B aortic dissection.

OBJECTIVE: The aim of this study was to investigate the correlation between post-implantation syndrome (PIS) and long-term prognosis in patients with Stanford type B aortic dissection (TBAD) undergoing thoracic endovascular aortic repair (TEVAR). METHODS: This retrospective study included 547 consecutive patients diagnosed with TBAD who underwent TEVAR at our institution between January 2014 and December 2019. Patients were categorized into two groups: the PIS group (patients with post-TEVAR PIS) and the non-PIS group (patients without post-TEVAR PIS). In-hospital and follow-up data were analyzed. RESULTS: The incidence of PIS was 28.9% (158/547 patients). No baseline differences were observed between the PIS (n = 158) and the non-PIS (n = 389) groups. The proportion of emergency surgery in the PIS group was higher than that in the non-PIS group (44.9% vs 26.0%; P < .001), the operation time was longer (median, 65.0; interquartile range [IQR], 56.0-75.0 minutes vs 56.0; IQR, 45.0-66.0 minutes; P < .001), the volume of contrast medium used (median, 65.0; IQR, 56.0-75.0 mL vs 56.0; IQR, 45.0-66.0 mL; P < .001), and the average number of trunk stents (1.85 ± 0.4 vs 1.34 ± 0.5 pieces; P < .001) and branch stents (0.7 ± 0.7 vs 0.2 ± 0.5 pieces; P < .001) used were more in the PIS group than in the non-PIS group. The incidence of supra-aortic branch procedures was higher in the PIS group than in the non-PIS group. There was no significant difference in device-related complications (DRCs) or 30-day mortality between the two groups (2.5% vs 4.4%; P = .442 and 1.3% vs 1.3%; P = .688, respectively). Univariate and multivariable logistic regression analysis showed that emergency surgery, number of trunk stents >1, operation time >58.5 minutes, and contrast medium volume >75 mL were risk factors for PIS, and the odds ratios of emergency operation, number of trunk stents >1 piece, operation time >58.5 minutes, and contrast medium volume >75 mL were 2.526 (95% confidence interval [CI], 1.530-4.173), 4.651 (95% CI, 2.838-7.624), 3.577 (95% CI, 2.201-5.815), and 7.356 (95% CI, 4.111-13.160), respectively. Follow-up was completed in 98.5% (532/540) of the patients, with a median follow-up of 67 months (IQR, 50-86 months). There was no significant difference in survival between the PIS and non-PIS groups (12.4% vs 10.3%; P = .476) during follow-up. The incidences of DRCs (7.8% vs 11.6%; P = .200) and aortic false lumen thrombosis (75.8% vs 79.2%; P = .399) were comparable between the PIS and non-PIS groups. Univariate logistic regression analysis showed that PIS had no effect on long-term follow-up mortality, DRCs, entry flow, or aortic false lumen thrombosis rate. CONCLUSIONS: PIS is relatively common after TEVAR and emergency surgery; number of trunk stents >1, operation time >58.5 minutes, and contrast medium volume >75 mL are of high predictive value for the assessment of PIS after TEVAR. However, PIS had little effect on early and late postoperative mortality or DRCs.

Impact of post-implantation syndrome on outcomes in acute type B aortic syndrome patients undergoing endovascular repair.

Background: The aim of this study was to explore the impact of post-implantation syndrome (PIS) on prognosis outcomes in individuals with type B acute aortic syndrome (AAS) undergoing thoracic endovascular aortic repair (TEVAR). Patients and methods: Data from type B AAS individuals who underwent TEVAR from January 2014 to April 2021 were retrospectively reviewed. Study subjects were divided into PIS and non-PIS (nPIS) groups and postoperative clinical outcomes were analyzed. Results: Our study cohort of 74 individuals with type B AAS included 40 aortic dissection (AD), 30 intramural hematoma (IMH), 4 penetrating aortic ulcer (PAU). The incidence of PIS was 14.9%. No statistically significant differences were found in baseline characteristics. The left subclavian artery (LSCA) reconstruction was performed more frequently among the PIS group (45.5% vs 9.5%, p=.008). Major adverse events (MAE) tended to be more frequent in the PIS group, but the difference was not significant (27.3% vs 22.2%, p=.707). At 2-year follow-up, results were comparable between the two groups. Kaplan-Meier analysis showed that PIS was not associated with a higher incidence of mortality, endoleak, new-onset AD, or stroke. A baseline neutrophil-to-lymphocyte ratio (NLR) >10.3 was associated with greater incidence of MAE. In individuals with IMH, better aortic remodeling evaluated by lower total aortic diameter/true lumen diameter (TAD/TLD) was achieved in the nPIS group (1.23±0.10 vs 1.43±0.07, p<.001), and a TAD/TLD ratio >1.32 was associated with significantly more MAE. Cox multivariate regression analysis also showed that a postoperative TAD/TLD ratio >1.32 was an independent risk factor for MAE (OR, 11.36; 95% CI, 1.53-84.26; p=.017). Conclusions: PIS was associated with a trend toward a higher incidence of MAE after TEVAR. In individuals with IMH, a TAD/TLD ratio >1.32 was an independent predictor of postoperative MAE.

Prospective evaluation of upper extremity access and total transfemoral approach during fenestrated and branched endovascular repair.

OBJECTIVE: Total transfemoral (TF) access has been increasingly used during fenestrated-branched endovascular aortic repair (FB-EVAR). However, it is unclear whether the potential decrease in the risk of cerebrovascular events is offset by increased procedural difficulties and other complications. The aim of this study was to compare outcomes of FB-EVAR using a TF vs upper extremity (UE) approach for target artery incorporation. METHODS: We analyzed the clinical data of consecutive patients enrolled in a prospective, nonrandomized clinical trial in two centers to investigate the use of FB-EVAR for treatment of complex abdominal aortic aneurysms (CAAA) and thoracoabdominal aortic aneurysms (TAAA) between 2013 and 2022. Patients were classified into TF or UE access group with a subset analysis of patients treated using designs with directional branches. End points were technical success, procedural metrics, 30-day cerebrovascular events defined as stroke or transient ischemic attack, and any major adverse events (MAEs). RESULTS: There were 541 patients (70% males; mean age, 74 ± 8 years) treated by FB-EVAR with 2107 renal-mesenteric TAs incorporated. TF was used in175 patients (32%) and UE in 366 patients (68%) including 146 (83%) TF and 314 (86%) UE access patients who had four or more TAs incorporated. The use of a TF approach increased from 8% between 2013 and 2017 to 31% between 2018 and 2020 and 96% between 2021 and 2022. Compared with UE access patients, TF access patients were more likely to have CAAAs (37% vs 24%; P = .002) as opposed to TAAAs. Technical success rate was 96% in both groups (P = .96). The use of the TF approach was associated with reduced fluoroscopy time and procedural time (each P < .05). The 30-day mortality rate was 0.6% for TF and 1.4% for UE (P = .67). There was no early cerebrovascular event in the TF group, but the incidence was 2.7% for UE patients (P = .035). The incidence of MAEs was also lower in the TF group (9% vs 18%; P = .006). Among 237 patients treated using devices with directional branches, there were no significant differences in outcomes except for a reduced procedural time for TF compared with UE access patients (P < .001). CONCLUSIONS: TF access was associated with a decreased incidence of early cerebrovascular events and MAEs compared with UE access for target artery incorporation. Procedural time was decreased in TF access patients irrespective of the type of stent graft design.

Sex-Comparative Outcomes of the T-Branch Device for the Treatment of Complex Aortic Aneurysms.

INTRODUCTION: Females are at increased risk of mortality compared to males after complex endovascular aortic repair. This study aims to examine sex-related peri-operative and follow-up outcomes in patients managed with the t-Branch device. METHODS: A two-center retrospective analysis of patients managed with the off-the-shelf t-Branch device (Cook Medical Inc., Bjaeverskov, Denmark) between 1 January 2014 and 30 September 2020 was performed. Primary outcomes were sex-comparative 30-day mortality, major adverse events (MAEs) and spinal cord ischemia (SCI). RESULTS: A total of 542 patients were included; 28.0% were females. Urgent repair and type I-III thoracoabdominal aneurysms were more common among females (52.6% vs. 34%, p = 0.01, and 57.1% vs. 35.8%, p = 0.004). Technical success was similar (97.4% vs. 96.9%, p = 0.755), as well as early mortality (16.2% in females vs. 10.8% in males; p = 0.084). SCI rates were similar between groups (13.6% vs. 9.2% p = 0.183). MAEs were more common in females; 33.7% vs. 21.4% (p = 0.022). Multivariate analysis did not identify sex as an independent predictor of adverse events. The 12-month survival rate was 75.7% (SE 0.045) for females and 84.1% (SE 0.026) for males (log rank, p = 0.10). CONCLUSIONS: Sex was not detected as an independent factor of mortality, MAEs and SCI within patients managed with the t-Branch device. Feasibility was high in both groups. No significant difference was shown in survival during the 12-month follow-up.

Clinical evaluation of two adult oxygenator systems in terms of mortality and major adverse events.

PURPOSE: The primary aim of this study was to examine the effects of two oxygenator systems on major adverse events and mortality. METHODS: A total of 181 consecutive patients undergoing coronary artery bypass grafting in our clinic were retrospectively analyzed. The patients were divided into two groups according to the oxygenator used: Group M, in which a Medtronic Affinity (Medtronic Operational Headquarters, Minneapolis, MN, USA) oxygenator was used, and Group S, in which a Sorin Inspire (Sorin Group Italia, Mirandola, Italy) oxygenator was used. RESULTS: Group S consisted of 89 patients, whereas Group M included 92 patients. No statistically significant differences were found between the two groups in terms of age (p = .112), weight (p = .465), body surface area (p = .956), or gender (p = .484). There was no statistically significant difference in hemorrhage on the first or second postoperative day (p = .318 and p = .455, respectively). No statistically significant differences were observed in terms of red blood cell (p = .468), fresh frozen plasma (p = .116), or platelet concentrate transfusion (p = .212). Infections, wound complications, and delayed sternal closure were significantly more common in Group M (p = .006, p = .023, and p = .019, respectively). Extracorporeal membrane oxygenators and intra-aortic balloon pumps were required significantly more frequently in Group S (p = .025 and p = .013, respectively). Major adverse events occurred in 16 (18%) patients in Group S and 14 (15.2%) patients in Group M (p = .382). Mortality was observed in six (6.7%) patients in Group S and three (3.3%) patients in Group M (p = .232). No statistically significant difference was found between the two groups in terms of length of hospital stay (p = .451). CONCLUSION: The clinical outcomes of the two oxygenator systems, including mortality, major adverse events, hemorrhage, erythrocyte and platelet transfusions, and length of hospital stay, were similar.

30-Day Outcomes of Transcatheter Tricuspid Annuloplasty With the K-Clip System: A Single-Center, Observational Study.

Background: Surgery for isolated functional tricuspid regurgitation (TR) poses a high risk. Several transcatheter approaches are being evaluated for the treatment of such patients. The K-Clip system is a percutaneous approach designed for functional TR; however, its utility remains unknown. Objectives: This study aimed to report the 30-day echocardiographic and clinical outcomes with the K-Clip system for severe TR, including changes in TR severity and NYHA functional class. Methods: Transcatheter tricuspid valve annuloplasty was performed in 39 patients with intermediate or high surgical risk who underwent the K-Clip system. The right internal jugular vein procedure was performed with annuloplasty guided by fluoroscopy and echocardiography. The primary outcomes were clinical success and all-cause mortality at the 30-day follow-up. Results: The K-Clip was successfully implanted in all cases, with 1 to 3 devices deployed. At the 30-day follow-up, none of the patients had died. TR severity was reduced by at least one grade in all patients. There were no severe procedural or 30-day adverse events, except for 1 new pacemaker implantation. The proportion of NYHA class III-IV patients decreased from 79.5% to 5.1%, and the ascites disappeared. The 6-minute walk distance increased by 78 m (P < 0.05), and the Kansas City Cardiomyopathy Questionnaire score improved by 11 points (P < 0.05). Conclusions: The K-Clip device is practical, safe, and effective for patients with severe TR. A 30-day reduction in TR and enhanced cardiac function and quality of life were associated with transcatheter tricuspid annuloplasty using the K-Clip device, according to short-term follow-up studies. (Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System [TriStar]; NCT05173233).

Predictors of major adverse events and complications after ventricular septal defects surgical closure in children less than 10 kg.

BACKGROUND: Ventricular septal defect (VSD) is the most common congenital cardiac defect for which outcomes are not uniform. There is a lack of consensus on the risk factors for the unfavorable outcomes following surgical VSD closure. AIM: The aim of this study was to determine the risk factors and the predictors of major adverse events (MAEs) and complications following surgical closure of VSD in children weighing less than 10 kg. METHODS: This retrospective cohort study included children less than 10 kg who underwent surgical closure of congenital VSD of any type with or without associated congenital heart diseases. Patients with associated major cardiac anomalies were excluded. Preoperative, operative and postoperative data were collected from medical records. RESULTS: This study included 127 patients 52.8% were males, the median age was 8.0 months (IQR = 6.0-11.0 months), and their median weight was 5.7 kg (IQR = 4.8-7.0). Mortality was in one patient (0.8%) Multivariable logistic regression analysis revealed that male sex group (observational data), previous pulmonary artery banding (PAB), and significant intraoperative residual VSD were significant risk factors for the development of MAEs (odds ratios were 3.398, 14.282, and 8.634, respectively). Trisomy 21 syndrome (odds ratio: 5.678) contributed significantly to prolonged ventilation. Pulmonary artery banding (odds ratio: 14.415), significant intraoperative (3 mm) residual VSD (odds ratio: 11.262), and long cross-clamp time (odds ratio: 1.064) were significant predictors of prolonged ICU stay, whereas prolonged hospital stay was observed significantly in male sex group (odds ratio: 12.8281), PAB (odds ratio: 2.669), and significant intraoperative (3 mm) residual VSD (odds ratio: 19.551). CONCLUSIONS: Surgical VSD repair is considered a safe procedure with very low mortality. Trisomy 21 was a significant risk factor for prolonged ventilation. Further, PAB, significant intraoperative residual of 3 mm or more that required a second pulmonary bypass, and a greater cross-clamp time were significant predictors of MAE and associated complications with prolonged ICU and hospital stay.

Comparison of short-term outcomes of mild and moderate hypothermic circulatory arrest in aortic arch surgery: a single center retrospective cohort study.

Background: Aortic arch surgery is one of the major challenges in modern aortic surgery, special cerebral and visceral organ protective strategies are still under progress. Whether mild hypothermic circulatory arrest (Mi-HCA) can be safely used in aortic arch surgery (AAS) is the focus of attention. Methods: From January 2017 to June 2021, a retrospective cohort study of 138 consecutive patients was conducted at Beijing Anzhen Hospital. The study comprised patients who underwent AAS performed by a single surgeon during moderate-to-mild HCA. According to the core temperature at the beginning of circulatory arrest, the patients were divided into three groups: T1 group (n=45; 25.76±0.75 ℃), T2 group (n=43; 28.79±0.81 ℃), T3 group (n=50; 31.46±0.79 ℃). Perioperative clinical data were analyzed to assess the differences between groups. Results: In this cohort, the average durations of the operation, cardiopulmonary bypass (CPB), cross-clamp, circulatory arrest, and selective antegrade cerebral perfusion (SACP) were 6.53±1.48 h, 184.07±56.69 min, 101.04±37.92 min, 23.01±9.86 min, and 27.18±11.52 min, respectively. We observed new postoperative permanent neurological dysfunction (PND) in 12 patients (8.7%) and transient neurological dysfunction in 18 patients (13.04%). The in-hospital mortality rate was 6.52% (n=9). The durations of the operation, CPB, cross-clamp, circulatory arrest, and SACP were significantly reduced in the Mi-HCA group (i.e., T3 group, P<0.001; P<0.001; P<0.001; P=0.002; P<0.001, respectively). The incidence of PND and major adverse events (MAEs) were significantly reduced among the three groups (P=0.025; P=0.035). Multivariate logistic regression analysis models showed that Mi-HCA was an independent protective factor in reducing postoperative MAEs [relative risk (RR) =0.12; 95% confidence interval (CI): 0.02-0.90; P=0.0385]. Conclusions: The short-term outcomes of Mi-HCA combined with SACP in AAS were acceptable. Similarly, the protection of distal organs and the spinal cord was observed compared to the MHCA strategy, and a lower incidence of MAEs was obtained. Current data suggest that the mild hypothermia strategy can be safely applied for AAS.

A Score to Predict the Risk of Major Adverse Drug Reactions Among Multi-Drug Resistant Tuberculosis Patients in Southern Ethiopia, 2014-2019.

Background: Adverse events (AE) contribute to poor drug adherence and withdrawal, which contribute to a low treatment success rate. AE are commonly reported among multi-drug resistance tuberculosis (MDR-TB) patients in Ethiopia. However, predictors of AE among MDR-TB patients were limited in Ethiopia. Thus, the current study aimed to develop and validate a score to predict the risks of major AE among MDR-TB patients in Southern Ethiopia. Methods: A retrospective follow-up study design was employed among MDR-TB patients from 2014-2019 in southern Ethiopia at selected hospitals. A least absolute shrinkage and selection operator algorithm was used to select the most potent predictors of the outcome. The adverse event risk score was built based on the multivariable logistic regression analysis. Discriminatory power and calibration were checked to evaluate the performance of the model. Bootstrapping method with 100 repetitions was used for internal model validation. Results: History of baseline khat use, long-term drug regimen use, and having coexisting disorders (co-morbidity) were predictors of AEs. The score has a satisfactory discriminatory power (AUC = 0.77, 95% CI: 0.68, 0.82) and a modest calibration (Prob > chi2 = 0.2043). It was found to have the same c-statistics after validation by bootstrapping method of 100 repetitions with replacement. Conclusion: A history of baseline khat use, co-morbidity, and long-term drug regimen use are helpful to predict individual risk of major adverse events in MDR-TB patients with a satisfactory degree of accuracy (AUC = 0.77).

Significant Prediction of In-hospital Major Adverse Events by D-Dimer Level in Patients With Acute Type A Aortic Dissection.

Background: Acute type A aortic dissection (ATAAD) is a rare, life-threatening condition affecting the aorta. This study explores the relationship between the level of admission D-dimer, which was assessed during the first 2 h from admission, and in-hospital major adverse events (MAE) with ATAAD. Methods: A total of 470 patients with enhanced computed tomography (CT) confirmed diagnosis of ATAAD who underwent operation treatment in Guangdong Provincial People's hospital between September 2017 and June 2021 were enrolled in the present study. The X-tile program was used to determine the optimal D-dimer thresholds for risk. Restricted cubic spline (RSC) was performed to assess the association between D-dimer and endpoint. The perioperative data were compared between the two groups, univariate and multivariate analyses were used to investigate the risk factors of major adverse events (in-hospital mortality, gastrointestinal bleeding, paraplegia, acute kidney failure, reopen the chest, low cardiac output syndrome, cerebrovascular accident, respiratory insufficiency, MODS, gastrointestinal bleeding, and severe infection). Results: Among 470 patients, 151 (32.1%) had MAE. In-hospital mortality was 7.44%. The patients with D-dimer >14,500 ng/ml were more likely to present with acute kidney failure, low cardiac output, cerebrovascular accident, multiple organ dysfunction syndromes (MODS), gastrointestinal bleeding, and severe infection. D-dimer level was an independent risk factor for acute kidney failure (OR 2.09, 95% CI: 1.25-3.51, p = 0.005), MODS (OR 6.40, 95% CI: 1.23-33.39, p = 0.028), gastrointestinal bleeding (OR 17.76, 95% CI: 1.99-158.78, p = 0.010) and mortality (OR 3.17, 95% CI: 1.32-7.63, p = 0.010). Multivariate regression analysis of adverse events also suggested that D-dimer >14,500 ng/ml (OR 1.68, 95% CI: 1.09-2.61, p = 0.020) was the independent risk factor of major adverse events. Conclusions: Increasing D-dimer levels were independently associated with the in-hospital MAE and thus can be used as a useful prognostic biomarker before the surgery.