Fasting vs no fasting prior to catheterisation laboratory procedures: the SCOFF trial.

BACKGROUND AND AIMS: Current guidelines recommend 6 hours of solid food and 2 hours of clear liquid fasting for patients undergoing cardiac procedures with conscious sedation. There are no data to support this practice, and previous single centre studies support the safety of removing fasting requirements. The objective of this study was to determine the non-inferiority of a no fasting strategy to fasting prior to cardiac catheterisation procedures which require conscious sedation. METHODS: This is a multicentre, investigator-initiated, non-inferiority randomised trial conduced in Australia with a prospective open label blinded endpoint design. Patients referred for coronary angiography, percutaneous coronary intervention or cardiac implantable electronic device (CIED) related procedures were enrolled. Patients were randomised 1:1 to fasting as normal (6 hours solid food and 2 hours clear liquid) or no fasting requirements (encouraged to have regular meals but not mandated to do so). Recruitment occurred from 2022 to 2023. The primary outcome was a composite of aspiration pneumonia, hypotension, hyperglycaemia and hypoglycaemia assessed with a Bayesian approach. Secondary outcomes included patient satisfaction score, new ventilation requirement (non-invasive and invasive), new intensive care unit admission, 30-day readmission, 30-day mortality, 30-day pneumonia. RESULTS: 716 patients were randomised with 358 in each group. Those in the fasting arm had significantly longer solid food fasting (13.2 versus 3.0 hours, Bayes factor >100 indicating extreme evidence of difference) and clear liquid fasting times (7.0 versus 2.4 hours, Bayes factor >100). The primary composite outcome occurred in 19.1% of patients in the fasting arm and 12.0% of patients in the no fasting arm. The estimate of the mean posterior difference in proportions in the primary composite outcome was -5.2% (95% CI -9.6 to -0.9, ) favouring no fasting. This result confirms non-inferiority (posterior probability >99.5%) and superiority (posterior probability 99.1%) of no fasting for the primary composite outcome. The no fasting arm had improved patient satisfaction scores with a posterior mean difference of 4.02 points (95% CI 3.36 to 4.67, Bayes factor >100). Secondary outcome events were similar. CONCLUSIONS: In patients undergoing cardiac catheterisation and CIED related procedures, no fasting was non-inferior and superior to fasting for the primary composite outcome of aspiration pneumonia, hypotension, hyperglycaemia and hypoglycaemia. Patient satisfaction scores were significantly better with no fasting. This supports removing fasting requirements for patients undergoing cardiac catheterisation laboratory procedures that require conscious sedation.

Six-Year Outcomes of Total Arch Replacement vs Debranching With TEVAR for Aortic Arch Pathologies: Meta-Analysis of Kaplan-Meier-Derived Data From Propensity Score-Matched Studies.

BACKGROUND: Total arch replacement (TAR) and debranching plus thoracic endovascular aortic repair (TEVAR) serve as significant therapeutic options for aortic arch pathologies. It remains unclear whether one of these approaches should be considered preferable. Our study aimed to compare the long-term outcomes of these 2 approaches. METHODS: We carried out a pooled meta-analysis of time-to-event data extracted from studies published by December 2023. Eligibility criteria included populations with any aortic arch pathology who underwent debranching plus TEVAR or TAR, propensity score-matched (PSM) studies (prospective/retrospective; single-center/multicentric), and the outcomes included follow-up for overall survival/mortality and/or reinterventions. RESULTS: Eleven PSM studies met our eligibility criteria, including a total of 1142 patients (571 matched pairs). We did not observe any statistically significant difference in the risk of all-cause death between the groups (hazard ratio [HR]=1.20, 95% confidence interval [CI]=0.91-1.56, p=0.202), but patients who underwent TAR had a significantly lower risk of late aortic reinterventions compared with patients who underwent debranching plus TEVAR (HR=0.38, 95% CI=0.23-0.64, p<0.001). Our meta-regression analyses for all-cause mortality identified statistically significant coefficients for age (coefficient=-0.047; p=0.012) and type A aortic dissections (coefficient=0.012; p=0.010). CONCLUSIONS: Debranching plus TEVAR and TAR demonstrate no statistically significant differences in terms of survival in patients with aortic arch pathologies, but TAR is associated with lower risk of late aortic reinterventions over time. Although older patients may benefit more from debranching plus TEVAR rather than from TAR, patients with dissections may benefit more from TAR. CLINICAL IMPACT: Although the 2 strategies seem to be equally valuable in terms of survival, total aortic arch replacement (when compared with debranching plus TEVAR to treat patients with aortic arch pathologies) is associated with reduction of late aortic reinterventions over time in patients with and without aortic dissections. However, we should consider debranching plus TEVAR in older patients as it is associated with lower risk of death in this population. The novelty of our study lies in the fact that, instead of comparing study-level effect estimates, we analyzed the outcomes with reconstructed time-to-event data. This offered us the opportunity of performing our analyses with a mathematically appropriate model which consider events and time; however, these findings might be under the influence of treatment allocation bias.

Advanced statistical methods for hazard modeling in cardiothoracic surgery: a comprehensive review of techniques and approaches.

Hazard modeling in cardiothoracic surgery, crucial for understanding patient outcomes, utilizes survival analysis like the Cox proportional hazards model. Kaplan-Meier curves are employed in survival analysis to represent the probability of survival over time. While Cox assumes proportional hazards, the Fine-Gray model deals with competing risks. Parametric models (e.g., Weibull) specify survival distributions, unlike Cox. Bayesian analysis integrates prior knowledge with data. Machine learning, including decision trees and support vector machines, enhances risk prediction by analyzing extensive datasets. However, it is important to note that whatever new approaches one may adopt will enhance the quality of risk assessment and not the risk assessment as such. Preprocessing is vital for data quality in complex cardiovascular datasets, alongside robust validation methods like cross-validation for model reliability across patient cohorts.

Mais Complicações em Mulheres após Revascularização do Miocárdio Mesmo com Tempos Cirúrgicos Reduzidos: Atenção por Equidade e Melhoria da Qualidade / More Hospital Complications in Women after Cabg Even for Reduced Surgical Times: Call to Action for Equity in Quality Improvement

Resumo Fundamento Análises em grandes registros apontam desfechos desfavoráveis para mulheres submetidas à cirurgia de revascularização do miocárdio (CRM), enquanto estudos randomizados sofrem com a falta de representatividade. Objetivo Comparar os resultados hospitalares ajustados entre homens e mulheres submetidos à CRM. Métodos Entre julho de 2017 e junho de 2019, 3991 pacientes foram submetidos à CRM primária isolada, tanto de forma eletiva como de urgência, em 5 hospitais de estado de São Paulo, Brasil. Para equilibrar as diferenças entre homens e mulheres, as populações foram ajustadas utilizando o Propensity Score Matching. Os desfechos considerados para análise foram os utilizados pelo STS Adult Database. As análises foram conduzidas no software R, considerando significância valores de p < 0,05. Resultados Após o Propensity Score Matching (1:1), cada grupo incluiu 1089 pacientes. Em relação às variáveis intraoperatórias os homens apresentaram maior tempo de CEC (p<0,001), tempo cirúrgico (p<0,001), número de anastomoses distais (p<0,001) e uso de enxertos arteriais. Em relação aos desfechos as mulheres apresentaram maior incidência de infecção de ferida profunda (p=0,006), tempo prolongado na Unidade de Terapia Intensiva (p=0,002), maior necessidade do uso de balão intraórtico (p=0,04), maior taxa de transfusão sanguínea (p<0,001), maior readmissão hospitalar em até 30 dias após a cirurgia (p=0,002) e maior taxa de óbitos (p=0,03). Conclusões Apesar dos homens terem apresentado um maior tempo de CEC, maior número de enxertos arteriais e maior número de anastomoses distais, os resultados imediatos após CRM foram piores em mulheres.

Abstract Background Analyses of extensive registries indicate adverse outcomes for women undergoing coronary artery bypass grafting (CABG) surgery, while randomized studies often lack representativeness. Objective To compare adjusted hospital outcomes between men and women undergoing CABG. Methods From July 2017 to June 2019, 3991 patients underwent primary isolated CABG, both electively and urgently, in 5 hospitals in the state of São Paulo, Brazil. To mitigate demographic differences between men and women, populations were adjusted using propensity score matching (PSM). The outcomes considered for analysis were those used by the STS Adult Database. The analyses were performed using R software, with a significance set at p<0.05. Results After PSM (1:1), each group included 1089 patients. Regarding intraoperative variables, men exhibited longer cardiopulmonary bypass (CPB) time (p<0.001), surgical time (p<0.001), a higher number of distal anastomoses (p<0.001), and increased use of arterial grafts. Regarding outcomes, women had a higher incidence of deep sternal wound infection (p=0.006), prolonged Intensive Care Unit stay (p=0.002), increased need for an intra-aortic balloon pump (p=0.04), higher blood transfusion rates (p<0.001), higher 30-day hospital readmission rates after surgery (p=0.002) and higher mortality rate (p=0.03). Conclusions Although men had longer CPB times, a greater number of arterial grafts, and a greater number of distal anastomoses, immediate results after CABG were poorer in women.

Age-Based Outcomes After Surgical Aortic Valve Replacement With Bioprosthetic Versus Mechanical Valves.

Recommendations for prosthesis type in older patients who underwent surgical aortic valve replacement (SAVR) are established, albeit undervalidated. The purpose of this study is to compare outcomes after bioprosthetic versus mechanical SAVR across various age groups. This was a retrospective study using an institutional SAVR database. All patients who underwent isolated SAVR were compared across valve types and age strata (<65 years, 65 to 75 years, >75 years). Patients who underwent concomitant operations, aortic root interventions, or previous aortic valve replacement were excluded. Objective survival and aortic valve reinterventions were compared. Kaplan-Meier survival estimation and multivariate regression were performed. A total of 1,847 patients underwent SAVR from 2010 to 2023. A total of 1,452 patients (78.6%) received bioprosthetic valves, whereas 395 (21.4%) received mechanical valves. Of those who received bioprosthetic valves, 349 (24.0%) were aged <65 years, 627 (43.2%) were 65 to 75 years, and 476 (32.8%%) were older than 75 years. For patients who received mechanical valves, 308 (78.0%) were aged <65 years, 84 (21.3%) were between 65 and 75 years, and 3 (0.7%) were >75 years. The median follow-up in the total cohort was 6.2 (2.6 to 8.9) years. No statistically significant differences were observed in early-term Kaplan-Meier survival estimates between SAVR valve types in all age groups. However, the cumulative incidence estimates of aortic valve reintervention were significantly higher in patients aged under 65 years who received bioprosthetic than those who received mechanical valves, with 5-year reintervention rates of 5.8% and 3.1%, respectively (p = 0.002). On competing risk analysis for valve reintervention, bioprosthetic valves were significantly associated with an increased hazard of aortic valve reintervention (hazard ratio 3.35, 95% confidence interval 1.73 to 6.49, p <0.001). In conclusion, SAVR with bioprosthetic valves (particularly, in patients aged <65 years) was comparable in survival to mechanical valve SAVR but significantly associated with increased valve reintervention rates.

Long-Term Outcomes of Mechanical Versus Bioprosthetic Aortic Valve Replacement in Patients Aged Under 50 Years: Meta-Analysis of Reconstructed Time-to-Event Data.

To compare the long-term outcomes of mechanical versus bioprosthetic aortic valve replacement (AVR) in patients aged <50 years, we performed a study-level meta-analysis with reconstructed time-to-event data including studies published by December of 2023. The primary outcome was overall survival. Secondary outcomes included reoperation, major bleeding, and stroke. A total of 5 studies met our inclusion criteria, with a total of 4,245 patients (2,311 mechanical and 1,934 bioprosthetic). All studies were observational and the mean age of groups across the studies ranged from 38.2 to 43.0 years. The median follow-up time was 11.4 years (interquartile range 6.9 to 15.0). Bioprosthetic AVR was associated with reduced overall survival and higher risk of all-cause death (hazard ratio [HR] 1.170 95% confidence interval [CI] 1.002 to 1.364, p = 0.046), increased risk of reoperation over time (HR 2.581, 95% CI 2.102 to 3.168, p <0.001), decreased risk of major bleeding (HR 0.500, 95% CI 0.367 to 0.682, p <0.001), and decreased risk of stroke (HR 0.751, 95% C, 0.565 to 0.998, p = 0.049) compared with mechanical AVR in patients aged <50 years. In conclusion, for patients aged <50 years, bioprosthetic AVR is associated with increased mortality and risk of reoperation compared with mechanical valves. In contrast, mechanical AVR is associated with an increased risk of major bleeding events and stroke. These aspects should be carefully considered during the selection of valve type in this age group; however, we should keep in mind that the statistically significant differences in the risk of all-cause death and stroke might not be clinically relevant (because of marginal statistical significance).

Lymphocyte Levels and Morbidity and Mortality in Cardiovascular Surgery With Cardiopulmonary Bypass.

INTRODUCTION: A year ago, in a sample of 113 patients, our research group found that a high number of lymphocytes in the immediate postoperative period was correlated to a poor prognosis in cardiovascular surgeries. This study is an expansion of the initial study in order to confirm this finding. METHODS: We analyzed the data of 338 consecutive patients submitted to cardiovascular surgeries with cardiopulmonary bypass performed at Hospital Universitário Ciências Médicas (Belo Horizonte/Brazil) from 2015 to 2017. We analyzed 39 variables with the outcomes death, hospital stay, and intensive care unit stay. RESULTS: The value of lymphocytes in the immediate postoperative period > 2175.0/mm³ was an indicator of poor prognosis in this sample (P<0.001). The variables female sex, age, high level of European System for Cardiac Operative Risk Evaluation II, increased stay in the intensive care unit and in the ward, elevation of creatinine in the preoperative period and at intensive care unit discharge, elevation of the percentage of immediate postoperative period segmented neutrophils, high immediate postoperative period neutrophil/lymphocyte ratio, fasting hyperglycemia, preoperative critical condition, reintubation, mild or transient acute renal failure, surgical infection, cardiopulmonary bypass, and aortic cross-clamping and mechanical ventilation durations also had an impact on the mortality outcome. CONCLUSION: The value of lymphocytes in the immediate postoperative period > 2175.0/mm3 was an indicator of poor prognosis in cardiovascular surgery with cardiopulmonary bypass.

[Characterization and risk prediction of cardiovascular surgeries with cardiopulmonary bypass: a cross-sectional study] / Caracterización y predicción del riesgo de cirugías cardiovasculares con uso de bomba de circulación extracorpórea.

Introduction: Cardiovascular surgery risk prediction models are widely applied in medical practice. However, they have been criticized for their low methodological quality and scarce external validation. An additional limitation added in Latin America is that most of these models have been developed in the United States or Europe, which present marked geographical differences. The objective of this study is to characterize the postoperative clinical events of cardiovascular surgeries with the use of cardiopulmonary bypass pump in a local setting and to evaluate the prediction of postoperative mortality using the EuroSCORE II predictive model. Methods: Cross-sectional study in an urban university hospital in Buenos Aires. Patients ≥21 years of age were included, with a clinical indication for on-pump cardiovascular surgery. Patients with incomplete clinical data regarding EuroSCORE II variables or in-hospital survival, ≥95 years of age, or undergoing heart transplantation were excluded. Results: 195 patients were enrolled. Postoperative mortality estimated by EuroSCORE II presented a clear underestimation of risk (3.0% vs 7.7%). Discrimination (AUC = 0.82; 95% CI 0.74-0.92) and goodness of fit of the model were adequate (χ2 = 7.91; p = 0.4418). The most frequent postoperative complications were postoperative heart failure (35.9%), vasoplegic shock (13.3%), and cardiogenic shock (10.26%). Conclusion: The EuroSCORE II is an appropriate tool to discriminate between different risk categories in patients undergoing on-pump cardiovascular surgery, although it underestimates the risk.

Introducción: Los modelos de predicción de riesgo de cirugías cardiovasculares se aplican ampliamente a la práctica médica. Sin embargo, han sido criticados por su baja calidad metodológica y escasa validación externa. En América Latina se agrega la limitación de que la mayoría de estos modelos fueron desarrollados en Estados Unidos o Europa, existiendo diferencias geográficas marcadas. Objetivo: El objetivo de este estudio es caracterizar los eventos clínicos postoperatorios de cirugías cardiovasculares con uso de bomba de circulación extracorpórea en un escenario local y evaluar la predicción de mortalidad postoperatoria del modelo predictivo EuroSCORE II. Métodos: Corte transversal en un hospital universitario urbano de Buenos Aires. Se incluyeron a pacientes ≥21 años de edad, con indicación de cirugía cardiovascular con uso de bomba. Se excluyeron a pacientes con datos clínicos incompletos respecto a las variables del EuroSCORE II o respecto a la sobrevida intrahospitalaria, con ≥95 años de edad o sometidos a trasplante cardíaco. Resultados: Se enrolaron 195 pacientes. La mortalidad postoperatoria estimada por el EuroSCORE II presentó una clara subestimación del riesgo (3,0% vs 7,7%). La discriminación (AUC = 0,82; IC95% 0,74-0,92) y la bondad del ajuste del modelo fueron adecuadas (χ2 = 7,91; p = 0,4418). Las complicaciones postoperatorias más frecuentes fueron insuficiencia cardíaca postoperatoria (35,9%), shock vasopléjico (13,3%) y shock cardiogénico (10,26%). Conclusión: El EuroSCORE II es una herramienta apropiada para discriminar entre diferentes categorías de riesgo en pacientes sometidos a cirugías cardiovasculares con uso de bomba, si bien subestima el riesgo.

Overcoming prosthesis-patient mismatch with transcatheter aortic valve replacement.

For decades, surgeons have recognized the risk of prosthesis-patient mismatch (PPM) when treating aortic stenosis (AS) with surgical aortic valve replacement (SAVR). The concept of PPM-or placing a valve that is too small for the cardiac output requirements of the patient-has been associated with worse patient outcomes, including increased risk of death. Transcatheter aortic valve replacement (TAVR) has become the standard treatment for most patients with severe symptomatic AS and is associated with improved hemodynamics and lower risks of PPM. Larger surgical valves, stentless, and sutureless technology, and surgical aortic annulus enlargement (AAE) have been employed to avoid severe PPM. However, especially in the small aortic annulus (SAA), TAVR may provide a benefit. Understanding who is at risk for PPM requires preplanning, and cardiac-gated computed tomography (CT) imaging is the standard of care when considering TAVR. It should be standard for all patients with AS. Once SAA is identified, the risk of PPM can be calculated, and an informed decision made on whether to proceed with SAVR or TAVR. In the current TAVR era, younger patients are treated with TAVR driven by patient preference, but with little long-term data to support the practice. Selecting the best valve for the patient is a multifactorial decision often nuanced by anatomical considerations, hemodynamic and durability expectations, and decisions regarding lifetime management that may include placing a second valve. Although PPM may be only one of the factors to consider, the association with elevated mean gradients and worse outcomes certainly makes TAVR a good solution for many patients.

Trends in Regional Disparities in Cardiovascular Surgery and Mortality in Korea: A National Cross-sectional Study.

OBJECTIVES: Regional disparities in cardiovascular care in Korea have led to uneven patient outcomes. Despite the growing need for and access to procedures, few studies have linked regional service availability to mortality rates. This study analyzed regional variation in the utilization of major cardiovascular procedures and their associations with short-term mortality to provide better evidence regarding the relationship between healthcare resource distribution and patient survival. METHODS: A cross-sectional study was conducted using nationwide claims data for patients who underwent coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), stent insertion, or aortic aneurysm resection in 2022. Regional variation was assessed by the relevance index (RI). The associations between the regional RI and 30-day mortality were analyzed. RESULTS: The RI was lowest for aortic aneurysm resection (mean, 26.2; standard deviation, 26.1), indicating the most uneven regional distribution among the surgical procedures. Patients undergoing this procedure in regions with higher RIs showed significantly lower 30-day mortality (adjusted odds ratio [aOR], 0.73; 95% confidence interval, 0.55 to 0.96; p=0.026) versus those with lower RIs. This suggests that cardiovascular surgery regional availability, as measured by RI, has an impact on mortality rates for certain complex surgical procedures. The RI was not associated with significant mortality differences for more widely available procedures like CABG (aOR, 0.96), PCI (aOR, 1.00), or stent insertion (aOR, 0.91). CONCLUSIONS: Significant regional variation and underutilization of cardiovascular surgery were found, with reduced access linked to worse mortality for complex procedures. Disparities should be addressed through collaboration among hospitals and policy efforts to improve outcomes.

Late Outcomes After Transcatheter Aortic Valve Implantation with Balloon-Versus Self-Expandable Valves: Meta-Analysis of Reconstructed Time-To-Event Data.

Self-expanding valves (SEV) and balloon-expandable valves (BEV) for transcatheter aortic valve implantation (TAVI) have their own features. There is a growing interest in long-term outcomes with the adoption of lifetime management in younger patients. To evaluate late outcomes in TAVI with SEV versus BEV, we performed a study-level meta-analysis of reconstructed time-to-event data published by May 31, 2023. We found no statistically significant difference in all-cause death after TAVI with SEV versus BEV. Randomized controlled trials are warranted to validate our results.

Long-Term Outcomes of Tricuspid Valve Replacement With Mechanical Versus Tissue Valves: Meta-Analysis of Reconstructed Time-to-Event Data.

Tricuspid valve replacement (TVR) with mechanical versus tissue valves remains a controversial subject. To evaluate the long-term effects of types of valves on patient-relevant outcomes, we performed a systematic review with meta-analysis of reconstructed time-to-event data of studies published by March 15, 2024 (according to referred the Reporting Items for Systematic Reviews and Meta-analyses guidelines). A total of 21 studies met our eligibility criteria and included 7,166 patients (mechanical: 2,495 patients, 34.8%). Patients who underwent mechanical TVR had a lower risk of death than those who received a tissue valve (hazard ratio [HR] 0.77, 95% confidence interval [CI] 0.70 to 0.84, p <0.001). Mechanical TVR was associated with lifetime gain, as evidenced by the restricted mean survival time, which was 2.2 years longer in patients who underwent TVR with mechanical valves (12.4 vs 10.2 years, p <0.001). Our landmark analysis for reoperations revealed the following: from the time point 0 to 7 years, we found no difference in the risk of reoperation between mechanical and tissues valves (HR 0.98, 95% CI 0.60 to 1.61, p = 0.946); however, from the time point 7 years onward, we found that mechanical TVR had a lower risk of reoperation in the follow-up (HR 0.24, 95% CI 0.08 to 0.72, p = 0.001). The meta-regression analysis demonstrated a modulating effect of atrial fibrillation on the association between mechanical valves and mortality; the HRs for all-cause death tended to decrease in the presence of populations with a larger proportion of atrial fibrillation (p = 0.018). In conclusion, our results suggest that TVR with mechanical valves, whenever considered clinically reasonable and accepted by patients as an option, can offer a better long-term survival and lower risk of reoperation in the long run.

Extracorporeal life support after surgical repair for acute type a aortic dissection: A systematic review and meta-analysis.

BACKGROUND: The use of extracorporeal life support (ECLS) in patients after surgical repair for acute type A aortic dissection (ATAAD) has not been well documented. METHODS: We performed a systematic review and meta-analysis to assess the outcomes of ECLS after surgery for ATAAD with data published by October 2023 in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and the Meta-analysis of Observational Studies in Epidemiology (MOOSE) reporting guidelines. The protocol was registered in PROSPERO (CRD42023479955). RESULTS: Twelve observational studies met our eligibility criteria, including 280 patients. Mean age was 55.0 years and women represented 25.3% of the overall population. Although the mean preoperative left ventricle ejection fraction was 59.8%, 60.8% of patients developed left ventricle failure and 34.0% developed biventricular failure. Coronary involvement and malperfusion were found in 37.1% and 25.6%, respectively. Concomitant coronary bypass surgery was performed in 38.5% of patients. Regarding ECLS, retrograde flow (femoral) was present in 39.9% and central cannulation was present in 35.4%. In-hospital mortality was 62.8% and pooled estimate of successful weaning was 50.8%. Neurological complications, bleeding and renal failure were found in 25.9%, 38.7%, and 65.5%, respectively. CONCLUSION: ECLS after surgical repair for ATAAD remains associated with high rates of in-hospital death and complications, but it still represents a chance of survival in critical situations. ECLS remains a salvage attempt and surgeons should not try to avoid ECLS at all costs after repairing an ATAAD case.

Late Outcomes of Surgery Versus Medical Therapy in Patients With Type A Aortic Intramural Hematoma: Meta-Analysis of Reconstructed Time-to-Event Data.

The effect of an initial surgical approach (in comparison with initial medical therapy) in acute type A intramural hematoma remains insufficiently explored. We designed a pooled analysis of Kaplan-Meier-derived individual patient data from studies with follow-up for overall survival (all-cause death). Restricted mean survival time was calculated to evaluate lifetime gain or loss. The Risk of Bias in Non-Randomized Studies of Interventions tool (ROBINS-I) was used to assess risk of bias. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) was applied to assess certainty of evidence. Eight studies met our eligibility criteria, including a total of 654 patients (311 patients treated with surgery and 343 patients treated with medical therapy alone). All the studies were non-randomized and observational. The median follow-up was 4.6 years (interquartile range 1.0 to 7.7). Patients who underwent surgery had a significantly lower risk of mortality compared with patients receiving medical therapy alone (hazard ratio 0.51, 95% confidence interval 0.35 to 0.74, p <0.001). The restricted mean survival time was overall 1.1 years greater with surgery compared with medical therapy, and this difference was statistically significant (p <0.001), which means that surgery is associated with lifetime gain. The overall risk of bias (ROBINS-I) was considered moderate-to-serious and the certainty of evidence (GRADE) was deemed to be low. In conclusion, in the overall follow-up, surgery as the initial approach was associated with better late survival and lifetime gain in comparison with medical therapy alone in the setting of acute type A aortic intramural hematoma; however, high-quality randomized trials are warranted to establish the efficacy of the surgical strategy.

Transcatheter versus surgical aortic valve replacement for severe aortic valve stenosis: Meta-analysis with trial sequential analysis.

OBJECTIVES: Randomized controlled trials comparing transcatheter aortic valve implantation with surgical aortic valve replacement demonstrate conflicting evidence, particularly in low-risk patients. We aim to reevaluate the evidence using trial sequential analysis, balancing type I and II errors, and compare with conventional meta-analysis. METHODS: Databases were searched for randomized controlled trials, which were divided into higher-risk and lower-risk randomized controlled trials according to a pragmatic risk classification. Primary outcomes were death and a composite end point of death or disabling stroke assessed at 1 year and maximum follow-up. Conventional meta-analysis and trial sequential analysis were performed, and the required information size was calculated considering a type I error of 5% and a power of 90%. RESULTS: Eight randomized controlled trials (n = 5274 higher-risk and 3661 lower-risk patients) were included. Higher-risk trials showed no significant reduction in death at 1 year with transcatheter aortic valve implantation (relative risk, 0.93, 95% CI, 0.81-1.08, P = .345). Lower-risk trials suggested lower death risk on conventional meta-analysis (relative risk, 0.67, 95% CI, 0.47-0.96, P = .031), but trial sequential analysis indicated potential spurious evidence (P = .116), necessitating more data for conclusive benefit (required information size = 5944 [59.8%]). For death or disabling stroke at 1 year, higher-risk trials lacked evidence (relative risk, 0.90, 95% CI, 0.79-1.02, P = .108). In lower-risk trials, transcatheter aortic valve implantation indicated lower risk in conventional meta-analysis (relative risk, 0.68, 95% CI, 0.50-0.93, P = .014), but trial sequential analysis suggested potential spurious evidence (P = .053), necessitating more data for conclusive benefit (required information size = 5122 [69.4%]). Follow-up results provided inconclusive evidence for both primary outcomes across risk categories. CONCLUSIONS: Conventional meta-analysis methods may have prematurely declared an early reduction of negative outcomes after transcatheter aortic valve implantation when compared with surgical aortic valve replacement.

Impact of Prosthesis-Patient Mismatch After Surgical Aortic Valve Replacement: Systematic Review and Meta-Analysis of Reconstructed Time-to-Event Data of 122 989 Patients With 592 952 Patient-Years.

BACKGROUND: It remains controversial whether prosthesis-patient mismatch (PPM) impacts long-term outcomes after surgical aortic valve replacement. We aimed to evaluate the association of PPM with mortality, rehospitalizations, and aortic valve reinterventions. METHODS AND RESULTS: We performed a systematic review with meta-analysis of reconstructed time-to-event data of studies published by March 2023 (according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses). Sixty-five studies met our eligibility criteria and included 122 989 patients (any PPM: 68 332 patients, 55.6%). At 25 years of follow-up, the survival rates were 11.8% and 20.6% in patients with and without any PPM, respectively (hazard ratio [HR], 1.16 [95% CI, 1.13-1.18], P<0.001). At 20 years of follow-up, the survival rates were 19.5%, 12.1%, and 8.8% in patients with no, moderate, and severe PPM, respectively (moderate versus no PPM: HR, 1.09 [95% CI, 1.06-1.11], P<0.001; severe versus no PPM: HR, 1.29 [95% CI, 1.24-1.35], P<0.001). PPM was associated with higher risk of cardiac death, heart failure-related hospitalizations, and aortic valve reinterventions over time (P<0.001). Statistically significant associations between PPM and worse survival were observed regardless of valve type (bioprosthetic versus mechanical valves), contemporary PPM definitions unadjusted and adjusted for body mass index, and PPM quantification method (in vitro, in vivo, Doppler echocardiography). Our meta-regression analysis revealed that populations with more women tend to have higher HRs for all-cause death associated with PPM. CONCLUSIONS: The results of the present study suggest that any degree of PPM is associated with poorer long-term outcomes following surgical aortic valve replacement and provide support for implementation of preventive strategies to avoid PPM after surgical aortic valve replacement.

Using machine learning to predict five-year transplant-free survival among infants with hypoplastic left heart syndrome.

Hypoplastic left heart syndrome (HLHS) is a congenital malformation commonly treated with palliative surgery and is associated with significant morbidity and mortality. Risk stratification models have often relied upon traditional survival analyses or outcomes data failing to extend beyond infancy. Individualized prediction of transplant-free survival (TFS) employing machine learning (ML) based analyses of outcomes beyond infancy may provide further valuable insight for families and healthcare providers along the course of a staged palliation. Data from both the Pediatric Heart Network (PHN) Single Ventricle Reconstruction (SVR) trial and Extension study (SVR II), which extended cohort follow up for five years was used to develop ML-driven models predicting TFS. Models incrementally incorporated features corresponding to successive phases of care, from pre-Stage 1 palliation (S1P) through the stage 2 palliation (S2P) hospitalization. Models trained with features from Pre-S1P, S1P operation, and S1P hospitalization all demonstrated time-dependent area under the curves (td-AUC) beyond 0.70 through 5 years following S1P, with a model incorporating features through S1P hospitalization demonstrating particularly robust performance (td-AUC 0.838 (95% CI 0.836-0.840)). Machine learning may offer a clinically useful alternative means of providing individualized survival probability predictions, years following the staged surgical palliation of hypoplastic left heart syndrome.

Comparison between conventional open-heart valve surgery and minimally invasive valve replacement surgery regarding the length of hospital stay and usage of blood derivates: insights from a single-centre, single-surgeon study conducted in Bosnia and Herzegovina.

Aim To analyse the correlation between different surgical methodologies employed in valve diseases treatment and their subsequent impact on the duration of hospitalization. Methods This retrospective study conducted at the Clinical Centre of the University of Sarajevo analysed medical records of 163 valve disease patients treated between January 2019 and November 2022. The patients were divided into two groups: 77 had openheart valve surgery and 86 underwent minimally invasive cardiac surgery (MICS). Results The mean duration of the surgical procedures was 3.9±1.3 hours, with conventional open-heart surgery requiring an average of 3.6±1.1 hours and minimally invasive cardiac surgery (MICS) procedure 4.2±1.5 hours. No substantial disparities were found in the total length of hospitalization between the two groups, as both conventional (8.2±4.5 days) and MICS (8.7±7.0 days) demonstrated similar duration. Similarly, the total duration of intensive care unit (ICU) stay displayed similarity, with conventional surgery patients staying an average of 3.9±2.8 days and MICS patients of 4.2±4.1 days. The pattern of blood transfusion and fresh-frozen plasma usage revealed higher rates in the conventional valve surgery group comparing to the MICS group. Conclusion Minimally invasive valve surgery, despite slightly longer operative times, resulted in lower blood transfusion requirements and comparable hospitalization and ICU stay.

Long-term sex-based outcomes after surgery for acute type A aortic dissection: Meta-analysis of reconstructed time-to-event data.

BACKGROUND: The influence of sex on outcomes of surgery for acute type A aortic dissection remains incompletely characterized. We sought to evaluate post-procedural survival in the follow-up of females versus males. METHODS: We carried out a systematic review with meta-analysis of Kaplan-Meier-derived time-to-event data from studies published by June 2023 in the following databases: PubMed/MEDLINE, EMBASE, Web of Science and CENTRAL/CCTR (Cochrane Controlled Trials Register). RESULTS: Twelve studies met our eligibility criteria, including 11,696 patients (3753 females; 7943 males). The mean age ranged from 41.2 to 72.6 years with low prevalence of bicuspid aortic valve (ranging from 0.0% to 12.0%) and connective tissue disorders (ranging from 0.8% to 7.3%). We found a considerable prevalence of coronary artery disease (ranging from 12.1% to 21.1%) and malperfusion (ranging from 20.0% to 46.3%). At 10 years, females undergoing surgery had a significantly higher risk of all-cause mortality compared with males (HR 1.25, 95%CI 1.14-1.38, P â€‹< â€‹0.001). CONCLUSION: In the follow-up of patients undergoing surgery for type A aortic dissection, females presented poorer overall survival in comparison with males.

Long-Term Outcomes of Valve-in-Valve Transcatheter Aortic Valve Implantation Versus Redo Surgical Aortic Valve Replacement: Meta-Analysis of Kaplan-Meier-Derived Data.

Valve-in-valve (ViV) transcatheter aortic valve implantation (ViV-TAVI) in patients with failed bioprostheses arose as an alternative to redo surgical aortic valve replacement (SAVR). To evaluate all-cause mortality in ViV-TAVI versus redo-SAVR, we performed a study-level meta-analysis of reconstructed time-to-event data from Kaplan-Meier curves of nonrandomized studies published by August 2023. A total of 16 studies met our eligibility criteria, with a total of 4,373 patients (2,204 patients underwent ViV-TAVI and 2,169 patients underwent redo-SAVR). Pooling all the studies, ViV-TAVI showed a lower risk of all-cause mortality in the first 6 months (hazard ratio [HR] 0.58, 95% confidence interval [CI] 0.46 to 0.73, p <0.001), with an HR reversal after this time point favoring redo-SAVR (HR 1.92, 95% CI 1.58 to 2.33, p <0.001). Pooling only the matched populations (which represented 64.6% of the overall population), ViV-TAVI showed a lower risk of all-cause mortality in the first 6 months (HR 0.56, 95% CI 0.43 to 0.73, p <0.001], with a reversal after 6 months favoring redo-SAVR (HR 1.55, 95% CI 1.25 to 1.93, p <0.001). The meta-regression analyses revealed a modulating effect of the following covariates: age, coronary artery disease, history of coronary artery bypass graft surgery, and implanted valves <25 mm. In conclusion, ViV-TAVI is associated with better survival immediately after the procedure than redo-SAVR; however, this primary advantage reverses over time, and redo-SAVR seems to offer better survival at a later stage. Because these results are pooled data from observational studies, they should be interpreted with caution, and randomized controlled trials are warranted.