Subclinical hypothyroidism and clinical outcomes after cardiac surgery: A systematic review and meta-analysis.

Background: Subclinical hypothyroidism (SCH) is associated with major adverse cardiovascular events. Despite the recognized negative impact of SCH on cardiovascular health, research on cardiac postoperative outcomes with SCH has yielded conflicting results, and patients are not currently treated for SCH before cardiac surgery procedures. Methods: We performed a study-level meta-analysis on the impact of SCH on patients undergoing nonurgent cardiac surgery, including coronary artery bypass grafting and valve and aortic surgery. The primary outcome was operative mortality. Secondary outcomes were hospital length of stay (LOS), intensive care unit (ICU) stay, postoperative atrial fibrillation (POAF), intra-aortic balloon pump (IABP) use, renal complications, and long-term all-cause mortality. Results: Seven observational studies, with a total of 3445 patients, including 851 [24.7%] diagnosed with SCH and 2594 [75.3%] euthyroid patients) were identified. Compared to euthyroid patients, the patients with SCH had higher rates of operative mortality (odds ratio [OR], 2.57; 95% confidence interval [CI], 1.09-6.04; P = .03), prolonged hospital LOS (standardized mean difference, 0.32; 95% CI, 0.02-0.62; P = .04), a higher rate of renal complications (OR, 2.53; 95% CI, 1.74-3.69; P < .0001), but no significant differences in ICU stay, POAF, or IABP use. At mean follow-up of 49.3 months, the presence of SCH was associated with a higher rate of all-cause mortality (incidence rate ratio, 1.82; 95% CI, 1.18-2.83; P = .02). Conclusions: Patients with SCH have higher operative mortality, prolonged hospital LOS, and increased renal complications after cardiac surgery. Achieving and maintaining a euthyroid state prior to and after cardiac surgery procedures might improve outcomes in these patients.

Statistical primer: individual patient data meta-analysis and meta-analytic approaches in case of non-proportional hazards.

Individual patient data (IPD) meta-analyses build upon traditional (aggregate data) meta-analyses by collecting IPD from the individual studies rather than using aggregated summary data. Although both traditional and IPD meta-analyses produce a summary effect estimate, IPD meta-analyses allow for the analysis of data to be performed as a single dataset. This allows for standardization of exposure, outcomes, and analytic methods across individual studies. IPD meta-analyses also allow the utilization of statistical methods typically used in cohort studies, such as multivariable regression, survival analysis, propensity score matching, uniform subgroup and sensitivity analyses, better management of missing data, and incorporation of unpublished data. However, they are more time-intensive, costly, and subject to participation bias. A separate issue relates to the meta-analytic challenges when the proportional hazards assumption is violated. In these instances, alternative methods of reporting time-to-event estimates, such as restricted mean survival time should be used. This statistical primer summarizes key concepts in both scenarios and provides pertinent examples.

Trends in the Management of Anterior Mitral Leaflet Regurgitation.

Importance: The overall prevalence of mitral valve replacement (MVR) or MV repair at the time of cardiac surgery in the setting of isolated anterior mitral leaflet degenerative pathologic status in the US population is unknown. Objective: To investigate the prevalence of MVR and MV repair using the Society of Thoracic Surgeons' Adult Cardiac Surgery Database. Design, Setting, and Participants: In a cross-sectional study, all patients diagnosed with isolated anterior mitral leaflet degenerative regurgitation who underwent either surgical MVR or MV repair between July 1, 2011, and June 30, 2022, were identified. Linear regression analysis was used to assess trends over time. Main Outcomes and Measures: Assessment of the trends in MV repair and MVR over time. Results: A total of 16 259 patients (9624 [59.2%] men) were identified, and the median age was 68 (IQR, 58-74) years. A total of 7214 patients (44.4%) had MVR, and 9045 (55.6%) had MV repair. There was a declining trend of MV repair from 58.0% in 2011 to 51.6% in 2022 (P = .05). The MVR group was older (median [IQR] age, 70 [62-77] vs 67 [58-74] years; P < .001) and had more comorbidities. A total of 85.1% of all patients underwent concomitant procedures. In 81.7% of MVR cases, no attempt at MV repair was made. The median (IQR) annual hospital volume was lower with MVR vs MV repair (2.50 [1.50-5.00] vs 4.00 [2.00-7.00]; P < .001). Conventional surgical approaches were most common (91.5%) but with a declining trend (P < .001). Minimally invasive approaches were used in 13.1% (robotic, 4.6%), and with an inclining trend from 5.0% in 2011 to 12.0% in 2022 (P < .001). Annuloplasty was performed in 88.8% of MV repair cases. Its use as a sole mean of MV repair decreased from 48.0% in 2011 to 13.9% in 2022 (P < .001). Repair maneuvers in addition to annuloplasty were neochordae (overall 40.1%, increasing from 22.5% in 2011 to 62.3% in 2022; P < .001), leaflet resection (overall 10.2%, decreasing from 13.1% in 2011 to 7.9% in 2022, P = .002), edge-to-edge MV repair (overall 5.3%, decreasing from 6.9% in 2011 to 4.5% in 2022; P = 0.04), and chordal transfer (overall 2.4%, decreasing from 2.7% in 2011 to 0.7% in 2022; P = .004). Conclusions and Relevance: In this cross-sectional study, MV repair was the preferred option for degenerative mitral valve disease but was only slightly more commonly performed than MVR for isolated anterior leaflet pathologic status. A large proportion of MVR was performed without an MV repair attempt, suggesting reluctance to repair this pathologic condition.

Transferring Surgical Expertise: Analyzing the Learning Curve of Robotic Cardiac Surgery Operative Time Reduction When Surgeon Moves from One Experienced Center to Another.

BACKGROUND: Robotically assisted cardiac surgery is performed in a team setting and is well known to be associated with learning curves. Surgeon and operative team learning curves are distinct entities, with total operative time representing the entire operative team (surgery, anesthesia, nursing, and perfusion) and cross-clamp time representing mainly the surgical team. Little is known about how a team learning curve evolves when an experienced surgeon transitions from one surgical center to another. This study investigates the dynamics of the team learning curve expressed as total operative time in the case of a surgeon with previous experience transitioning to a new team. METHODS: A retrospective analysis was conducted on robotic cardiac surgeries performed by a surgeon who transitioned from one experienced surgical center to another. Operative time data were collected and categorized to assess the evolution of the learning curve. Statistical analysis, including learning curve modeling and linear regression analysis, was used to evaluate changes in total time in the operating room per case. RESULTS: 103 cases were included in Weill Cornell Medicine (2019-2023). The median patient age was 63 years, 68% were males, 90.3% of cases were repaired for degenerative mitral valve disease, and the median body mass index was 23.87. Operative time (ORT) decreased from a median of 5.00 h [95%CI: 4.76, 6.00] in the first 30 cases to 4.83 [95%CI: 4.10, 5.27] thereafter, with the apparent curve plateauing indicative of the adaptation period to the new surgical environment (p = 0.01). Subgroup analysis among mitral cases (n = 93) showed a decrease in ORT from 5.00 [95%CI: 4.71, 5.98] in the first 26 cases to 4.83 [95%CI: 4.14, 5.30] (p = 0.045). There was no difference between the initial 30 cases and subsequent cases regarding cardiopulmonary bypass time, myocardial ischemia time, reoperation for bleeding, prolonged ventilation, reintubation, renal failure, need for an intra-aortic balloon pump, readmission to the ICU, reoperation for valvular dysfunction within 30 days, pneumonia, and deep venous thrombosis. Multivariate significant predictors of longer operative time were the first 30 cases, resection-based repairs, and MAZE as a concomitant procedure. CONCLUSIONS: Total operative time can be expected to decrease after about 30 cases when an experienced robotic surgeon moves between centers. Complications and cross-clamp times are less susceptible to a learning curve phenomenon in such a circumstance, as these depend primarily on the operating surgeon's level of experience. Understanding these dynamics can inform the planning and management of surgical transitions, ensuring optimal patient care and continued improvement in surgical outcomes.

Thorax support vest to prevent sternal wound infections in cardiac surgery patients-a systematic review and meta-analysis.

OBJECTIVES: Midline sternotomy is the main surgical access for cardiac surgeries. The most prominent complication of sternotomy is sternal wound infection (SWI). The use of a thorax support vest (TSV) that limits thorax movement and ensures sternal stability has been suggested to prevent postoperative SWI. METHODS: We performed a meta-analysis to evaluate differences in clinical outcomes with and without the use of TSV after cardiac surgery in randomized trials. The primary outcome was deep SWI (DSWI). Secondary outcomes were superficial SWI, sternal wound dehiscence, and hospital length of stay (LOS). A trial sequential analysis was performed. Fixed (F) and random effects (R) models were calculated. RESULTS: A total of 4 studies (3820 patients) were included. Patients who wore the TSV had lower incidence of DSWI [odds ratio (OR) = F: 0.24, 95% confidence interval (CI), 0.13-0.43, P < 0.01; R: 0.24, 0.04-1.59, P = 0.08], sternal wound dehiscence (OR = F: 0.08, 95% CI, 0.02-0.27, P < 0.01; R: 0.10, 0.00-2.20, P = 0.08) and shorter hospital LOS (standardized mean difference = F: -0.30, -0.37 to -0.24, P < 0.01; R: -0.63, -1.29 to 0.02, P = 0.15). There was no difference regarding the incidence of superficial SWI (OR = F: 0.71, 95% CI, 0.34-1.47, P = 0.35; R: 0.64, 0.10, 4.26, P = 0.42). The trial sequential analysis, however, showed that the observed decrease in DSWI in the TSV arm cannot be considered conclusive based on the existing evidence. CONCLUSIONS: This meta-analysis suggests that the use of a TSV after cardiac surgery could potentially be associated with a reduction in sternal wound complications. However, despite the significant treatment effect in the available studies, the evidence is not solid enough to provide strong practice recommendations.

Impact of Center Volume on Cardiopulmonary and Mortality Outcomes after Immune-Checkpoint Inhibitors for Cancer: A Systematic Review and Meta-Analysis.

Immune-checkpoint inhibitors (ICIs) were proven effective in inducing tumor regression. However, its toxicity tends to be fatal. We sought to investigate the hospital volume/outcomes relationship. Databases were searched for studies reporting immune-checkpoint inhibitors adverse events (AEs) in patients with solid-organ malignancies. The outcomes were A) the pooled events rate (PER) of grade 5, grade 3-4, cardiac-related, and pulmonary-related AEs, and B) the assessment of the volume/outcomes relationship. One hundred and forty-seven studies met our inclusion criteria. The PER of grade 5, grade 3-4, and any-grade AEs was 2.75% (95%CI: 2.18-3.47), 26.69% (95%CI: 21.60-32.48), and 77.80% (95%CI: 70.91-83.44), respectively. The PER of pulmonary-related AEs was 4.56% (95%CI: 3.76-5.53). A higher number of annual cases per center was significantly associated with reduced grade 5 (p = 0.019), grade 3-4 (p = 0.004), and cardiac-related AEs (p = 0.035) in the meta-regression. In the current era of cancer immunotherapy, knowledge regarding the early diagnosis and management of immunotherapy-related AEs is essential. Our meta-analysis demonstrates the importance of center volume in improving outcomes and reducing the incidence of severe AEs.

Characteristics and Outcomes of Stem Cell Transplant Patients during the COVID-19 Era: A Systematic Review and Meta-Analysis.

This systematic review and meta-analysis aims to identify the outcomes of stem cell transplant (SCT) patients during the COVID-19 era. Pooled event rates (PER) were calculated, and meta-regression was performed. A random effects model was utilized. In total, 36 eligible studies were included out of 290. The PER of COVID-19-related deaths and COVID-19-related hospital admissions were 21.1% and 55.2%, respectively. The PER of the use of hydroxychloroquine was 53.27%, of the receipt of immunosuppression it was 39.4%, and of the use of antivirals, antibiotics, and steroids it was 71.61%, 37.94%, and 18.46%, respectively. The PER of the time elapsed until COVID-19 infection after SCT of more than 6 months was 85.3%. The PER of fever, respiratory symptoms, and gastrointestinal symptoms were 70.9, 76.1, and 19.3%, respectively. The PER of acute and chronic GvHD were 40.2% and 60.9%, respectively. SCT patients are at a higher risk of severe COVID-19 infection and mortality. The use of dexamethasone improves the survival of hospitalized SCT patients with moderate to severe COVID-19 requiring supplemental oxygen or ventilation. The SCT patient group is a heterogeneous group with varying characteristics. The quality of reporting on these patients when infected with COVID-19 is not uniform and further prospective or registry studies are needed to better guide clinical care in this unique setting.

Outcomes by sex in the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial.

BACKGROUND: In the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial, among participants with stable coronary artery disease, the risk of cardiac events was similar between an invasive (INV) strategy of angiography and coronary revascularisation and a conservative (CON) strategy of initial medical therapy alone. Outcomes according to participant sex were not reported. AIMS: We aimed to analyse the outcomes of ISCHEMIA by participant sex. METHODS: We evaluated 1) the association between participant sex and the likelihood of undergoing revascularisation for participants randomised to the INV arm; 2) the risk of the ISCHEMIA primary composite outcome (cardiovascular death, any myocardial infarction [MI] or rehospitalisation for unstable angina, heart failure or resuscitated cardiac arrest) by participant sex; and 3) the contribution of the individual primary outcome components to the composite outcome by participant sex. RESULTS: Of 5,179 randomised participants, 1,168 (22.6%) were women. Female sex was independently associated with a lower likelihood of revascularisation when assigned to the INV arm (adjusted odds ratio 0.75, 95% confidence interval [CI]: 0.57-0.99; p=0.04). The INV versus CON effect on the primary composite outcome was similar between sexes (women: hazard ratio [HR] 0.96, 95% CI: 0.70-1.33; men: HR 0.90, 95% CI: 0.76-1.07; pinteraction=0.71). The contribution of the individual components to the composite outcome was similar between sexes except for procedural MI, which was significantly lower in women (9/151 [5.9%]) than men (67/519 [12.9%]; p=0.01). CONCLUSIONS: In ISCHEMIA, women assigned to the INV arm were less likely to undergo revascularisation than men. The effect of an INV versus CON strategy was consistent by sex, but women had a significantly lower contribution of procedural MI to the primary outcome.

Survival difference among adult and pediatric mediastinal yolk sac tumors cases: A meta-analysis of case reports.

BACKGROUND: Mediastinal Yolk sac tumors (YST) are rare and highly malignant extragonadal germ cell tumors with rapid growth and early metastases. We sought to conduct a meta-analysis of published case reports/case series to compare differences in survival, demographics, and treatment modalities between adult and pediatric patients with YST. METHODS: Ovid Embase, Cochrane, and Ovid Medline databases were searched for primary mediastinal pure YST cases. The primary outcome was overall survival (OS). Log-rank and Cox regression were used. This study is registered on PROSPERO (CRD42022367586). RESULTS: Among 846 studies, 87 met our inclusion criteria including 130 patients (Adults: 90 and Pediatrics: 40). About 41.5% of the patients were from the United States. The median age was 23.0 (Q1-Q3: 17.0-30.0), 88.5% were males, and (32.3%) were Asian. Stage II represented almost 40%. AFP was elevated in 96.9%. Respiratory distress was the presenting symptom in 65.4%. Chemotherapy, radiotherapy, and surgery were utilized in 84.6, 23.1, and 64.7% respectively. Median OS was 24 months (Adults: 23 months, Pediatrics: 25 months, P = 0.89). 3- and 5-year OS were 34.4% and 22.9% in adults and 41.5% and 41.5% in pediatrics, respectively. On multivariate analysis, anterior location of tumors, receipt of chemotherapy, and undergoing surgery were associated with better OS. CONCLUSION: Primary mediastinal YSTs are rare, but lethal neoplasms. Our meta-analysis showed that mediastinal YSTs mimic other non-seminomatous mediastinal GCTs in terms of clinical characteristics and available treatment options. Early diagnosis, neoadjuvant chemotherapy, and surgical resection are the key points for effective management and improved outcomes.

Intraoperative Anemia Mediates Sex Disparity in Operative Mortality After Coronary Artery Bypass Grafting.

BACKGROUND: Women undergoing coronary artery bypass grafting (CABG) have higher operative mortality than men. OBJECTIVES: The purpose of this study was to evaluate the relationship between intraoperative anemia (nadir intraoperative hematocrit), CABG operative mortality, and sex. METHODS: This was a cohort study of 1,434,225 isolated primary CABG patients (344,357 women) from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (2011-2022). The primary outcome was operative mortality. The attributable risk (AR) (the risk-adjusted strength of the association of female sex with CABG outcomes) for the primary outcome was calculated. Causal mediation analysis derived the total effect of female sex on operative mortality risk and the proportion of that effect mediated by intraoperative anemia. RESULTS: Women had lower median nadir intraoperative hematocrit (22.0% [Q1-Q3: 20.0%-25.0%] vs 27.0% [Q1-Q3: 24.0%-30.0%], standardized mean difference 97.0%) than men. Women had higher operative mortality than men (2.8% vs 1.7%; P < 0.001; adjusted OR: 1.36; 95% CI: 1.30-1.41). The AR of female sex for operative mortality was 1.21 (95% CI: 1.17-1.24). After adjusting for nadir intraoperative hematocrit, AR was reduced by 43% (1.12; 95% CI: 1.09-1.16). Intraoperative anemia mediated 38.5% of the increased mortality risk associated with female sex (95% CI: 32.3%-44.7%). Spline regression showed a stronger association between operative mortality and nadir intraoperative hematocrit at hematocrit values <22.0% (P < 0.001). CONCLUSIONS: The association of female sex with increased CABG operative mortality is mediated to a large extent by intraoperative anemia. Avoiding nadir intraoperative hematocrit values below 22.0% may reduce sex differences in CABG operative mortality.

Succinate dehydrogenase mutations in head and neck paragangliomas: A systematic review and meta-analysis of individual patients' data.

BACKGROUND: Head and neck paragangliomas (HNPs) have been associated with gene mutations in the succinate dehydrogenase (SDH) complex, but the clinical significance remains unclear. We sought to explore the demographics, clinical characteristics, treatment methods, and outcomes of SDH-mutated HNPs. METHODS: Databases were systematically searched. Pooled event ratio and relative 95% confidence intervals were calculated for dichotomous outcomes. Meta-regression was performed. Cochran's Q test and I2 test assessed heterogeneity. Funnel plot and Egger's regression test assessed publication bias. RESULTS: Forty-two studies with 8849 patients were included. Meta-regression revealed a significant correlation between multifocality and SDHD mutations (0.03 ± 0.006, p < 0.0001) and between distant metastases and SDHB mutations (0.06 ± 0.023, p = 0.008). There was no correlation between sex, age, tumor size, or familial occurrences and SDH-related mutations. CONCLUSION: Multifocality of HNPs correlates with the SDHD mutational subtype, and metastases correlate with the SDHB subtype. Knowledge of HNP phenotypes associated with SDH-related mutations has the potential to influence the management approach to such HNPs.

Outcomes According to Coronary Revascularization Modality in the ISCHEMIA Trial.

BACKGROUND: In the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial, the risk of ischemic events was similar in patients with stable coronary artery disease treated with an invasive (INV) strategy of angiography and percutaneous coronary intervention (PCI) or surgical (coronary artery bypass grafting [CABG]) coronary revascularization and a conservative (CON) strategy of initial medical therapy. OBJECTIVES: The authors analyzed separately the outcomes of INV patients treated with PCI or CABG. METHODS: Patients without preceding primary outcome events were categorized as INV-PCI or INV-CABG from the time of revascularization. The ISCHEMIA primary outcome (composite of cardiovascular death, protocol-defined myocardial infarction or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest) was used. RESULTS: Among INV-CABG patients, primary outcome events occurred in 84 of 512 (16.4%) at a median follow-up of 2.85 years; 48 events (57.1%) occurred within 30 days after CABG, including 40 procedural MIs. Among INV-PCI patients, primary outcome events occurred in 147 of 1,500 (9.8%) at median follow-up of 2.94 years; 31 of which (21.1%) occurred within 30 days after PCI, including 24 procedural MIs. In comparison, 352 of 2,591 CON patients (13.6%) had primary outcome events at a median follow-up of 3.2 years, 22 of which (6.3%) occurred within 30 days of randomization. The adjusted primary outcome risks were higher after both CABG and PCI within 30 days (HR: 16.25 [95% CI: 11.44-23.07] and HR: 2.99 [95% CI: 1.97-4.53]) and lower thereafter (0.63 [95% CI: 0.44-0.89] and 0.66 [95% CI: 0.53-0.82]). CONCLUSIONS: In ISCHEMIA, early revascularization by PCI and CABG was associated with higher early risks and lower long-term risks of cardiovascular events compared with CON. The early risk was greatest after CABG, owing to protocol-defined procedural MIs.

Surgically Resected Cardiac Angiosarcoma: Survival Analysis from the National Cancer Database.

Angiosarcoma is a rare type of soft-tissue sarcoma arising from endothelial cells. It is considered 'high-grade' by definition, reflecting its aggressive behavior. We sought to investigate the role of surgery in cardiac angiosarcoma, identify late mortality predictors, and identify interactions with other modalities in its treatment using a national dataset. The 2004-2017 National Cancer Database was reviewed for patients with primary cardiac angiosarcoma. Late mortality predictors were evaluated with Kaplan-Meier curves and Cox regression analysis. Surgery in primary cardiac angiosarcoma was performed in 130 patients (median age 50.5 years; female sex 36.9%). The median follow up was 72.02 months, with a median overall survival (OS) of 14.32 months. In patients treated with surgery in combination with other modalities compared with those treated with surgery alone, median OSs were 17.28 and 2.88 months, respectively (log-rank = 0.018). Older patients (age > 57 years) experienced lower OS compared to those with an age < 57 (log-rank = 0.012). This may be partially explained by the difference in treatment strategies among age groups: those with increasing age, less surgery (p = 0.037), and less chemotherapy (p < 0.001) were chosen. With multivariable Cox regression analysis, age and race other than white or black were identified to be significant independent predictors of late mortality. Cardiac angiosarcoma has poor overall survival, and our findings should further encourage the use of surgery in combination with other therapeutic modalities in treating such an aggressive disease whenever possible.

Spinal cord injury after open and endovascular repair of descending thoracic aneurysm and thoracoabdominal aortic aneurysm: an updated systematic review and meta-analysis.

Background: Spinal cord injury (SCI) is a rare but severe complication after open or endovascular repair of descending thoracic aneurysms (DTAs) or thoracoabdominal aortic aneurysms (TAAAs). This meta-analysis aims to provide a comprehensive assessment of SCI rates and factors associated with SCI. Methods: A systematic literature search was performed in September 2022 looking for studies on open and/or endovascular repair of DTA and/or TAAA published after 2018, to update the results of our previously published meta-analysis. The primary outcome was permanent SCI. Secondary outcomes were temporary SCI, 30-day and in-hospital mortality, follow-up mortality, postoperative stroke, and cerebrospinal fluid (CSF) drain-related complications. Data were pooled as proportions using inverse-variance weighting. Results: A total of 239 studies (71 new studies and 168 from our previous meta-analysis) and 61,962 patients were included. The overall pooled rate of permanent SCI was 3.3% [95% confidence interval (CI), 2.9-3.8%]. Open repair was associated with a permanent SCI rate of 4.0% (95% CI, 3.3-4.8%), and endovascular repair was associated with a permanent SCI rate of 2.9% (95% CI, 2.4-3.5%). Permanent SCI was 2.0% (95% CI, 1.2-3.3%) after DTA repair, and 4.7% (95% CI, 3.9-5.6%) after TAAA repair; permanent SCI rate was 3.8% (95% CI, 2.9-5.0%) for Crawford extent I, 13.4% (95% CI, 9.0-19.5%) for extent II, 7.1% (95% CI, 5.7-8.9%) for extent III, 2.3% (95% CI, 1.6-3.5%) for extent IV, and 6.7% (95% CI, 1.7-23.1%) for extent V TAAA aneurysms. The pooled rate of CSF drain related complications was 1.9% (95% CI, 0.8-4.7%) for severe, 0.4% (95% CI, 0.0-4.0%) for moderate, and 1.8% (95% CI, 0.6-5.6%) for minor complications. Conclusions: Permanent SCI occurs after both endovascular and open DTA or TAAA repairs. Open repairs and TAAA repairs have higher risk of SCI compared with endovascular or DTA repairs. In particular, extent II aneurysms present the highest overall risk of SCI.

Predictors of premature termination and completion of randomized controlled trials.

Randomized clinical trials (RCTs) have a key role in progressing biomedical research and guiding clinical decision making, but premature termination remains high (up to 30%), raising concerns regarding funding expenditure and resource allocation. This brief report sought to identify variables associated with RCTs' premature termination and completion.

Risk profile and operative outcomes in patients with and without Marfan syndrome undergoing thoracoabdominal aortic aneurysm repair.

OBJECTIVES: To compare operative and long-term outcomes between patients with and without Marfan syndrome undergoing thoracoabdominal aortic aneurysm repair. METHODS: We identified all consecutive patients undergoing thoracoabdominal aortic aneurysm repair between 1997 and 2022. Primary outcome was composite of major adverse events. Secondary outcomes were individual complications and long-term survival. Inverse probability of treatment weighting was performed. Weighted Kaplan-Meier curves were used to estimate long-term survival. Multivariable analysis identified factors associated with major adverse events. RESULTS: Six hundred eighty-four patients underwent open thoracoabdominal aortic aneurysm repair. Ninety (13.1%) had Marfan syndrome, whereas 594 (86.9%) did not. Marfan patients were younger (46 years [range, 36-56 years] vs 69 years [range, 61-76 years]; P < .001). Extent II or III aneurysms (57 out of 90 [63.3%] vs 211 out of 594 [35.6%]; P < .001) and type I or III chronic dissection (77 out of 90 [85.3%] vs 242 out of 594 [40.8%]; P < .001) were more common. Cardiovascular risk factors were less frequent in Marfan patients. There was no difference in major adverse events between groups (12 out of 90 [13.3%] vs 100 out of 594 [16.8%]; P = .49). Operative mortality was similar between groups (3 out of 90 [3.3%] vs 28 out of 594 [4.7%]; P = .75). Unweighted survival at 10 years was 78.7% vs 46.8% (P = .001). Weighted Kaplan-Meier curves showed no difference in long-term survival (adjusted hazard ratio, 0.79; 95% CI, 0.32-1.99; P = .62; Log-rank P = .12). At multivariable analysis, renal insufficiency (odds ratio, 2.29; 95% CI, 1.43-3.68; P < .01) and urgent/emergency procedure (odds ratio, 2.17; 95% CI, 1.35-3.48; P < .01) were associated with major adverse events, whereas Marfan syndrome was not (odds ratio, 1.56; 95% CI, 0.69-3.49; P = .28). CONCLUSIONS: Open thoracoabdominal aortic aneurysm repair can be performed with similar operative outcomes in patients with and without Marfan syndrome despite differing risk profiles. Operative/perioperative strategies must be tailored to specific needs of each patient to optimize outcomes.

Primary Cardiac Schwannoma: A Meta-Analysis of Individual Case Reports.

Primary cardiac schwannoma (PCS) is a neurogenic tumor that arises from Schwann cells. Malignant schwannoma (MSh) is an aggressive cancer comprising 2% of all sarcomas. Information on the proper management of these tumors is limited. Four databases were searched for case reports/series of PCS. The primary outcome was overall survival (OS). Secondary outcomes included therapeutic strategies and the corresponding outcomes. Among 439 potentially eligible studies, 53 met the inclusion criteria. The patients included had 43.72 ± 17.76 years and 28.3% were males. Over 50% of patients had MSh, with 9.4% also demonstrating metastases. Schwannoma commonly occurs in the atria (66.0%). Left-sided PCS were more common than right-sided ones. Surgery was performed in almost 90% of the cases; chemotherapy and radiotherapy were used in 16.9% and 15.1% of cases, respectively. Compared to benign cases, MSh occurs at a younger age and is commonly located on the left side. OS of the entire cohort at 1 and 3 years were 60.7%, and 54.0%, respectively. Females and males OS were similar up to 2 years follow-up. Surgery was associated with higher OS (p < 0.01). Surgery is the primary treatment option for both benign and malignant cases and was the only factor associated with a relative improvement in survival.