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.

Five Year Results of Endovascular versus Medical Therapy in Acute Type B Aortic Intramural Haematoma: Meta-Analysis of Reconstructed Time to Event Data.

OBJECTIVE: To evaluate outcomes in the follow up of thoracic endovascular aortic repair (TEVAR) vs. medical therapy in patients with acute type B aortic intramural haematoma (IMH). DATA SOURCES: The following sources were searched for articles meeting the inclusion criteria and published by July 2023: PubMed/MEDLINE, EMBASE, CENTRAL/CCTR (Cochrane Controlled Trials Register). REVIEW METHODS: This systematic review with pooled meta-analysis of time to event data followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines, and its protocol was registered on the public platform PROSPERO (CRD42023456222). The following were analysed: overall survival (all cause mortality), aortic related mortality, and restricted mean survival time. Certainty of evidence was evaluated through the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) tool. RESULTS: Eight studies met the eligibility criteria, including 1 015 patients (440 in the TEVAR group and 575 in the medical therapy group). All studies were observational, and the pooled cohort had a median follow up of 5.1 years. Compared with patients who received medical therapy alone, those who underwent TEVAR had a statistically significantly lower risk of all cause death (HR 0.44, 95% CI 0.30 - 0.65; p < .001; GRADE certainty: low), lower risk of aortic related death (HR 0.04, 95% CI 0.01 - 0.31; p = .002; GRADE certainty: low) and lifetime gain (restricted mean survival time was overall 201 days longer with TEVAR; p < .001). CONCLUSION: Thoracic endovascular aortic repair may be associated with lower risk of all cause and aortic related death compared with medical therapy in patients with acute type B IMH; however, the underlying data are not strong enough to draw robust clinical conclusions. Randomised controlled trials with large sample sizes and longer follow up are warranted to elucidate this question.

Echocardiographic markers at diagnosis of persistent pulmonary hypertension of the newborn.

OBJECTIVES: Clinical parameters along with echocardiographic markers are used to interrogate the haemodynamics in persistent pulmonary hypertension of the newborn (PPHN). The aim of this study was to compare different echocardiographic markers in recent cohort of newborn infants with and without PPHN. METHODS: In this retrospective study, common echocardiographic markers were examined in infants>34 weeks' gestation with PPHN (cases) and without PPHN (controls). Infants with congenital heart disease were excluded. Binary regression testing was used to evaluate echocardiographic markers predicting PPHN and death. In addition, diagnostic accuracy testing of echocardiographic markers using ROC was also performed. Intra-observer reliability for echocardiographic markers was examined using coefficient of variation (CoV) and intraclass correlation. RESULTS: Fifty-two infants were studied; 22 (42 %) infants with PPHN had significantly higher oxygen requirement, oxygenation index and ventilation days when compared with controls. Echocardiographic markers such as TR Vmax, S/D TR, PAAT, TAPSE and eccentricity index (EI) were significantly different between cases and controls. Receiver operator characteristics analysis of echocardiographic markers revealed TR Vmax 0.96 (0.9-1.0), S/D TR 0.95 (0.87-1.0) and end systolic EI 0.94 (0.87-1.0). These markers were found to predict death in this cohort of infants. CoV and Intra-observer reliability was good for various echocardiographic markers. CONCLUSIONS: Among the various echocardiographic markers studied, TR Vmax when present along with S/D TR and end systolic EI had good intra-observer reliability and were diagnostic of PPHN and predicted death in this cohort. Future trials could use these markers in studies examining PPHN.

pECGreview: Assessment of a Novel Tool to Evaluate the Accuracy of Pediatric ECG Interpretation Skills.

The skill of interpretation of the electrocardiogram (ECG) remains poor despite existing educational initiatives. We sought to evaluate the validity of using a subjective scoring system to assess the accuracy of ECG interpretations submitted by pediatric cardiology fellows, trainees, and faculty to the Pediatric ECG Review (pECGreview), a web-based ECG interpretation training program. We conducted a retrospective, cross-sectional study of responses submitted to pECGreview. ECG interpretations were assessed independently by four individuals with a range of experience. Accuracy was assessed using a 3-point scale: 100% for generally correct interpretations, 50% for over- or underdiagnosis of minor ECG abnormalities, and 0% for over- or underdiagnosis of major ECG abnormalities. Inter-rater agreement was assessed using expanded Bland-Altman plots, Pearson correlation coefficients, and Intraclass Correlation Coefficients (ICC). 1460 ECG interpretations by 192 participants were analyzed. 107 participants interpreted at least five ECGs. The mean accuracy score was 76.6 ± 13.7%. Participants were correct in 66.1 ± 5.1%, had minor over- or underdiagnosis in 21.5 ± 4.6% and major over- or underdiagnosis in 12.3 ± 3.9% of interpretations. Validation of agreement between evaluators demonstrated limits of agreement of 11.3%. Inter-rater agreement exhibited consistent patterns (all correlations ≥ 0.75). Absolute agreement was 0.74 (95% CI 0.69-0.80), and average measures agreement was 0.92 (95% CI 0.89-0.94). Accuracy score analysis of as few as five ECG interpretations submitted to pECGreview yielded good inter-rater reliability for assessing and ranking ECG interpretation skills in pediatric cardiology fellows in training.

Impaired Myocardial Work in Children with Hypertrophic Cardiomyopathy and Left Ventricular Fibrosis on Cardiac Magnetic Resonance Imaging.

Echocardiography is pivotal for diagnosis and monitoring of hypertrophic cardiomyopathy (HCM) and can evaluate myocardial function using myocardial work (MW) calculations. Echocardiography is often supplemented by cardiovascular magnetic resonance (CMR) imaging, which can detect myocardial fibrosis using late gadolinium enhancement (LGE). We sought to study the relationship between baseline LGE and MW at baseline and during follow-up in pediatric HCM patients. During the study period (2008-2023), 75 patients were followed up for HCM. In 14 patients (age 14.2 ± 2.8 years, 50.0% male, 6.4 ± 2.9 years follow-up), both LGE-CMR and echocardiography were performed. Global work index (GWI), global constructive work (GCW), global wasted work, and global work efficiency (GWE) were measured, and myocardial fibrosis was estimated by qualitative assessment of LGE. Patients with LGE (n = 7) exhibited significantly impaired baseline MW, including GWI (mean difference, MD - 487.4 mmHg %, 95% CI [- 866.8 mmHg % to - 108.3 mmHg %], p = 0.027), GCW (MD - 536.8 mmHg %, 95% CI [- 929.8 mmHg % to - 144.4 mmHg %], p = 0.020), and GWE (MD - 4.4%, 95% CI [- 8.1% to - 0.7%], p = 0.039). Regional analysis revealed impaired MW indices in segments with LGE, notably basal and mid septal segments. GWI demonstrated high diagnostic performance for LGE presence (sensitivity 93%, specificity 88%, and area under receiver operating characteristic curve 0.85). Baseline LGE presence had no significant impact on MW deterioration during follow-up. MW is significantly impaired in HCM patients with myocardial fibrosis, highlighting potential utility of echocardiography-derived MW analysis as a valuable tool.

Multiple recurrent supraventricular tachycardia in infantile tuberous sclerosis complex: management requiring triple-drug therapy.

We report the case of a female neonate admitted to the neonatal ICU with a rapid, narrow-complex tachyarrhythmia determined to be supraventricular tachycardia. Multimodality imaging and genetic testing confirmed a diagnosis of tuberous sclerosis complex with multiple cardiac rhabdomyomas. At 13 days of age, the patient was readmitted, exhibiting recurrent supraventricular tachycardia non-responsive to first-line treatment. Management required triple-drug therapy, whereafter the patient remained stable without recurrences. This is a rare report of supraventricular tachycardia in a functionally normal heart with the occurrence of supraventricular tachycardia due to structural abnormalities, with the possibility of multiple concealed accessory pathways.

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.

Preterm Birth Is Associated With Adverse Cardiac Remodeling and Worse Outcomes in Patients With a Functional Single Right Ventricle.

OBJECTIVE: To assess the effects of preterm birth on cardiac structure and function and transplant-free survival in patients with hypoplastic left heart syndrome and associated anomalies throughout the staged palliation process. STUDY DESIGN: Data from the Single Ventricle Reconstruction trial were used to assess the impact of prematurity on echocardiographic measures at birth, Norwood, Stage II, and 14 months in 549 patients with a single functional right ventricle. Medical history was recorded once a year using medical records or telephone interviews. Cox regression models were applied to analyze transplant-free survival to age 6 years. Causal mediation analysis was performed to estimate the mediating effect of birth weight within this relationship. RESULTS: Of the 549 participants, 64 (11.7%) were born preterm. Preterm-born participants had lower indexed right ventricle end-diastolic volumes at birth but higher volumes than term-born participants by age 14 months. Preterm-born participants had an increased risk of death or heart transplantation from birth to age 6 years, with an almost linear increase in the observed risk as gestational age decreased below 37 weeks. Of the total effect of preterm birth on transplant-free survival, 27.3% (95% CI 2.5-59.0%) was mediated through birth weight. CONCLUSIONS: Preterm birth is associated with adverse right ventricle remodeling and worse transplant-free survival throughout the palliation process, in part independently of low birth weight. Further investigation into this vulnerable group may allow development of strategies that mitigate the impact of prematurity on outcomes in patients with hypoplastic left heart syndrome.

Cusp-overlap versus coplanar view in transcatheter aortic valve implantation with self-expandable valves: A meta-analysis of comparative studies.

BACKGROUND: Permanent pacemaker implantation (PPI) is a common complication after transcatheter aortic valve implantation (TAVI). The cusp-overlap view (COV) was adopted to reduce PPI risk after TAVI with self-expandable valves (SEVs); however, the evidence remains scarce. We performed a systematic review with meta-analysis comparing COV and the standard coplanar view (CPV) technique to evaluate their effectiveness and safety. METHODS: Following the PRISMA statement, data were extracted from studies published by August 2022 and found in PubMed/MEDLINE, EMBASE, CENTRAL/CCTR, ClinicalTrials.gov, SciELO, LILACS, and Google Scholar. The primary outcome of interest was post-procedural PPI and the secondary outcomes were new left bundle branch block (LBBB), moderate/severe paravalvular leak (PVL), valve dislocation (pop-out); need of second transcatheter heart valve, 30-day mortality, stroke, conversion to surgery, coronary obstruction, implantation depth (mm), and post-TAVI mean gradients (mmHg). RESULTS: Eleven studies met our eligibility criteria and included 1464 patients in the COV group and 1743 patients in the CPV group. Patients who underwent TAVI with COV had lower risk of PPI (odds ratio 0.48; 95% confidence interval [CI] 0.33-0.70; p = 0.001) and higher implantation depths with COV (mean difference -0.83; 95% CI -1.2 to -0.45; p < 0.001). We did not observe any statistically significant differences in the rates of new LBBB, moderate/severe PVL, valve dislocation, need of second transcatheter heart valve, 30-day mortality, stroke, conversion to surgery, coronary obstruction, and post-TAVI mean gradients (mmHg). CONCLUSION: In TAVI with SEVs, the application of COV is associated with lower risk of PPI compared with the standard CPV without increasing risk for adverse outcomes.

Computed tomography-derived membranous septum length as predictor of conduction abnormalities and permanent pacemaker implantation after TAVI: A meta-analysis of observational studies.

BACKGROUND: Permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) is associated with higher risk of mortality and rehospitalization for heart failure. Efforts to prevent conduction abnormalities (CA) requiring PPI after TAVI should be made. The membranous septum (MS) length and its interaction with implantation depth (ID-ΔMSID) could provide useful information about the risk of CA/PPI following TAVI. OBJECTIVES: To identify MS length and ΔMSID as predictors of CA/PPI following TAVI. METHODS: Study-level meta-analysis of studies published by September 30, 2022. RESULTS: Eighteen studies met our eligibility including 5740 patients. Shorter MS length was associated with a significantly higher risk of CA/PPI (per 1 mm decrease: odds ratio [OR] 1.60, 95% confidence interval [CI] 1.28-1.99, p < 0.001). Similarly, lower ΔMSID was associated with a significantly higher risk of CA/PPI (per 1 mm decrease: OR 1.75, 95% CI 1.32-2.31, p < 0.001). Meta-regression analyses revealed a statistically significant modulation of the effect of shorter MS length and lower ΔMSID on the outcome (CA/PPI) by balloon postdilatation (positive regression coefficients with p < 0.001); with increasing use of balloon postdilatation, the effect of shorter MS length and lower ΔMSID on the outcome increased. MS length and ΔMSID demonstrated excellent discriminative abilities, with diagnostic ORs equaling 9.49 (95% CI 4.73-19.06), and 7.19 (95% CI 3.31-15.60), respectively. CONCLUSION: Considering that short MS length and low ΔMSID are associated with higher risk of CA and PPI, we should include measurement of MS length in the pre-TAVI planning with MDCT and try to establish optimal ID values before the procedure to avoid CA/PPI.

Impaired myocardial deformation persists at 2 years in offspring of mothers with diabetes mellitus.

BACKGROUND: A diabetic intrauterine environment has been proposed as a potential etiological mechanism for in utero programming of cardiac disease, and is associated with impaired fetal cardiac function. We aimed to assess cardiac function in offspring of mothers with diabetes mellitus (ODM) and determine whether fetal cardiac abnormalities persist during follow-up. METHODS: Longitudinal observational study to evaluate and compare myocardial function in 40 ODM to age-matched control offspring (CO). Myocardial deformation was measured using speckle-tracking echocardiography (STE). RESULTS: Significant differences were detected in global longitudinal strain (-20.9 ± 3.1 vs. -23.6 ± 2.2%; p = 0.001), global circumferential strain (-24.4 ± 3.9 vs. -26.9 ± 2.7%; p = 0.017), average radial strain (29.0 ± 9.8 vs. 37.1 ± 7.2%; p = 0.003), average longitudinal systolic strain rate (-1.24 ± 0.25/s vs. -1.47 ± 0.30/s; p = 0.011) and average circumferential systolic strain rate (-1.56 ± 0.37/s vs. -1.84 ± 0.37/s; p = 0.013) in comparison to CO up to 2 years of follow-up. Minimal differences were observed within ODM over the 2-year period. CONCLUSION: Impaired cardiac function in ODM persists during 2 years follow-up. Functional cardiac assessment might therefore be useful to detect these unfavorable changes, independent of screening for congenital heart disease or hypertrophic cardiomyopathy in this population. IMPACT: We demonstrate persistence of subclinical myocardial deformation abnormalities in offspring of mothers with diabetes mellitus from fetal life to early childhood years. These results extend the cellular observations in basic and translational research of developmental programming into the clinical realm. Persistence of subclinical myocardial deformation abnormalities may shed light on the known incidence of early cardiovascular disease in offspring of mother with diabetes. Cardiac myocardial strain assessment can be useful to detect these abnormalities, independent of screening for congenital heart disease or hypertrophic cardiomyopathy in this population.

Midterm Outcomes of Endovascular vs. Medical Therapy for Uncomplicated Type B Aortic Dissection: Meta-Analysis of Reconstructed Time to Event Data.

OBJECTIVE: To evaluate outcomes of thoracic endovascular aortic repair (TEVAR) vs. medical therapy in uncomplicated type B aortic dissections (TBAD). DATA SOURCES: PubMed/MEDLINE, EMBASE, SciELO, LILACS, CENTRAL/CCTR, Google Scholar, and reference lists of relevant articles. REVIEW METHODS: This was a pooled meta-analysis of time to event data extracted from studies published by December 2022 for the following outcomes: all cause mortality, aortic related mortality, and late aortic interventions. Certainty of evidence was evaluated through the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) tool. RESULTS: Ten studies met the eligibility criteria (eight observational; two randomised trials), comprising 17 906 patients (2 332 patients in the TEVAR groups and 15 574 patients in the medical therapy group). Compared with patients who received medical therapy, patients who underwent TEVAR had a statistically significantly lower risk of all cause death (HR 0.79, 95% CI 0.72 - 0.87, p < .001; GRADE certainty: low) and lower risk of aortic related death (HR 0.43, 95% CI 0.30 - 0.62, p < .001; GRADE certainty: low) without statistically significant difference in the risk of late aortic interventions (HR 1.05, 95% CI 0.88 - 1.26, p = .56; GRADE certainty: low). In the subgroup analyses, TEVAR was associated with lower risk of all cause death when randomised controlled trials only were pooled (HR 0.44, 95% CI 0.23 - 0.83, p = .012; GRADE certainty: moderate), younger patients only (HR 0.56, 95% CI 0.47 - 0.67, p < .001; GRADE certainty: low), Western populations only (HR 0.85, 95% CI 0.77 - 0.93, p = .001; GRADE certainty: low) and non-Western populations only (HR 0.47, 95% CI 0.35 - 0.62, p < .001; GRADE certainty: low). For all cause mortality and aortic related mortality, restricted mean survival time was overall 396 days and 398 days longer with TEVAR (p < .001), respectively, which means that TEVAR was associated with lifetime gain. CONCLUSION: TEVAR may be associated with better midterm survival and lower risk of aortic related death in the follow up of patients treated for uncomplicated TBAD compared with medical therapy; however, randomised controlled trials with larger sample sizes and longer follow up are still warranted.

Risk factors for acute kidney injury after pediatric cardiac surgery: a meta-analysis.

BACKGROUND: Cardiac surgery-associated acute kidney injury (AKI) is associated with increased morbidity and mortality in both adults and children. OBJECTIVES: This study aimed to identify clinical risk factors for AKI following cardiac surgery in the pediatric population. DATA SOURCES: PubMed/MEDLINE, Embase, Scopus, and reference lists of relevant articles were searched for studies published by August 2020. STUDY ELIGIBILITY CRITERIA: Studies were included if (1) the population consisted of pediatric patients (< 18 years old), (2) patients underwent cardiac surgery, (3) risk factors were compared between patients who developed AKI and those who did not, and (4) studies were prospective or retrospective observational studies or randomized controlled trials. PARTICIPANTS AND INTERVENTIONS: Children undergoing pediatric cardiac surgery. STUDY APPRAISAL AND SYNTHESIS METHODS: Random-effects meta-analysis was performed, comparing potential risk factors between pediatric patients who developed CS-AKI and those who did not. RESULTS: Sixty-one publications including a total of 19,680 participants (AKI: 7257 participants; no AKI: 12,423 participants) were included from studies published between 2008 and 2020. The pooled estimated incidence of AKI was 34.3% (95% confidence interval 30.0-38.8%, I2 = 96.8%). Binary risk factors that were significantly and consistently associated with AKI were the presence of pulmonary hypertension, cyanotic heart disease, univentricular heart, risk adjustment for congenital heart surgery 1 (RACHS-1) score ≥ 3, vasopressor use, cardiopulmonary bypass use, reoperation, and sepsis. Significant continuous risk factors included younger age, lower body weight, lower preoperative creatinine, higher preoperative estimated glomerular filtration rate (eGFR), higher RACHS-1 score, longer surgery time, longer cardiopulmonary bypass time, longer aortic cross-clamp time, and higher red blood cell transfusion volume. LIMITATIONS: Results are limited by heterogeneity and potential residual confounding. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: Our meta-analysis identified clinical risk factors that are associated with AKI in children undergoing cardiac surgery. This might help clinicians anticipate and manage more carefully this population and implement standardized preventive strategies. SYSTEMATIC REVIEW REGISTRATION NUMBER: CRD42021262699. A higher resolution version of the Graphical abstract is available as Supplementary information.

Late Outcomes After Aortic Root Enlargement During Aortic Valve Replacement: Meta-Analysis With Reconstructed Time-To-Event Data.

OBJECTIVES: The present authors aimed to assess the late outcomes of patients undergoing aortic root enlargement (ARE) at the time of surgical aortic valve replacement (SAVR). DESIGN: Study-level meta-analysis with reconstructed time-to-event data. SETTING: Follow-up of patients after surgical procedure. PARTICIPANTS: Adult patients with aortic valve disease requiring surgery. INTERVENTIONS: SAVR with ARE versus SAVR without ARE. MEASUREMENTS AND MAIN RESULTS: This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline. The following databases were searched for studies meeting the authors' inclusion criteria and published by November 30, 2021: PubMed/MEDLINE, Embase, SciELO, LILACS, CCTR/CENTRAL, and Google Scholar. Nine nonrandomized studies met the authors' eligibility criteria. All studies were nonrandomized. A total of 213,134 patients (SAVR with ARE: 7,556 patients; SAVR without ARE: 205,578 patients) were included from studies published from 1997 to 2021. The total rate of AAE was 3.7%, varying in the studies from 2.9% to 28.1%. The studies consisted of patients whose mean age varied from 63 to 79 years. Patients in the SAVR with ARE group had a significantly better overall survival (hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.90-0.99, p = 0.016) in the unmatched populations, but the matched analysis revealed no difference between SAVR with/without ARE in terms of overall survival (HR, 1.06; 95% CI, 0.90-1.25; p = 0.474). CONCLUSIONS: In the context of patients undergoing SAVR with or without ARE, patients who undergo ARE do not experience worse late outcomes. Further randomized controlled trials are needed to confirm or refute the authors' current findings.

Long-term outcomes of total arch replacement versus proximal aortic replacement in acute type A aortic dissection: Meta-analysis of Kaplan-Meier-derived individual patient data.

OBJECTIVES: To evaluate the long-term outcomes of a conservative approach (with proximal aortic replacement with or without hemiarch replacement) versus an aggressive approach (with total aortic arch replacement) in the treatment of acute type A aortic dissection (ATAAD). METHODS: We performed a pooled analysis of Kaplan-Meier-derived individual patient data from studies with follow-up comparing the aforementioned approaches to treat patients with ATAAD. RESULTS: Eighteen studies met our eligibility criteria, comprising 5243 patients with follow-up (Conservative: 3676 patients; Aggressive: 1567 patients). We observed a statistically significant difference in overall survival favoring the aggressive approach (hazard ratios [HR] 0.86, 95% confidence interval [CI] 0.76-0.98, p = .022), but no statistically significant difference in the risk of reoperation (HR 0.89, 95% CI 0.66-1.2, p = .439) in the overall follow-up. Landmark analyses revealed that, in the first 3 months after the procedure, mortality rates were comparable between conservative and aggressive approaches (HR 1.04, 95% CI 0.88-1.24, p = .627), but the results beyond 3 months showed improved survival in patients undergoing the aggressive surgical procedure (HR 0.71, 95% CI 0.59-0.85, p < .001). The landmark analyses also revealed that, in the first 7 years after the procedure, reoperation rates were comparable between the approaches (HR 1.03, 95% CI 0.76-1.40, p = .848), but the results beyond 7 years showed a lower risk of reoperation in patients undergoing the aggressive surgical procedure (HR 0.10, 95% CI 0.01-0.75, p = .025). CONCLUSION: The aggressive approach seems to confer better long-term survival and lower risk of the need for reoperation in the follow-up of patients treated for ATAAD.

Immediate and late outcomes of transcatheter aortic valve implantation versus surgical aortic valve replacement in bicuspid valves: Meta-analysis of reconstructed time-to-event data.

BACKGROUND: Outcomes of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) in patients with aortic stenosis and bicuspid aortic valve (BAV) must be better investigated. METHODS: A meta-analysis including studies published by January 2022 reporting immediate outcomes (in-hospital death, stroke, acute kidney injury [AKI], major bleeding, new permanent pacemaker implantation [PPI], paravalvular leakage [PVL]), mortality in the follow-up (with Kaplan-Meier curves for reconstruction of individual patient data). RESULTS: Five studies met our eligibility criteria. No statistically significant difference was observed for in-hospital death, stroke, AKI, and PVL. TAVI was associated with lower risk of major bleeding (odds ratio [OR]: 0.29; 95% confidence interval [CI]: 0.12-0.69; p = .025), but higher risk of PPI (OR: 2.00; 95% CI: 1.05-3.77; p = .041). In the follow-up, mortality after TAVI was significantly higher in the analysis with the largest samples (HR: 1.24, 95% CI: 1.01-1.53, p = .043), but no statistically significant difference was observed with risk-adjusted populations (HR: 1.06, 95% CI: 0.86-1.32, p = .57). Landmark analyses suggested a time-varying risk with TAVI after 10 and 13 months in both largest and risk-adjusted populations (HR: 2.13, 95% CI: 1.45-3.12, p < .001; HR: 1.7, 95% CI: 1.11-2.61, p = .015, respectively). CONCLUSION: Considering the immediate outcomes and comparable overall survival observed in risk-adjusted populations, TAVI can be used safely in selected BAV patients. However, a time-varying risk is present (favoring SAVR over TAVI at a later timepoint). This finding was likely driven by higher rates of PPI with TAVI.

Optimal shunt type for Norwood procedure: Predicted adverse impact of discordant surgical approach.

BACKGROUND: The Single Ventricle Reconstruction (SVR) trial compared survival after Norwood procedure with either modified Blalock Taussig shunt (MBTS) or right ventricle pulmonary artery shunt (RVPAS). METHODS: Data from all 549 participants in the SVR trial were used to develop the MBTS TFSA algorithms, which predicted the transplantation free survival advantage (TFSA) following MBTS versus RVPAS at 1 and 6 years after Norwood procedure. Linear regression analysis of the MBTS TFSA values was performed to identify factors related to more optimal outcomes with MBTS at each timepoint. The impact of discordant management (ie. predicted shunt type did not equal the one actually received) on outcomes and the extent of inconsistencies between predictions were evaluated. RESULTS: The MBTS TFSA algorithm favored MBTS over RVPAS for only 6.2% of participants at 1 year and for 27.0% at 6 years. In terms of both 1- and 6-year outcomes, MBTS was favored with younger age at Norwood procedure and pre-Norwood intubation, while RVPAS was favored with younger gestational age and metrics indicating larger RV size in the parasternal echocardiographic views. Other predictors were timepoint specific. MBTS TFSA based allocation could have led to an absolute risk reduction in heart transplantation and mortality of 8.0% at 1 year and 16.8% at 6 years, mostly by preventing discordant MBTS management. Notably, separate predictions from the 1 year and 6-year algorithms produced discordant predictions for 136 participants (24.8%). CONCLUSIONS: The incorporation of data derived patient specific factors for selection of shunt type for the Norwood procedure may produce more optimal transplantation free survival. These precision medicine algorithms require prospective validation.

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).

Computational simulation of the potential improvement in clinical outcomes of cardiovascular diseases with the use of a personalized predictive medicine approach.

IMPORTANCE AND OBJECTIVES: The current medical paradigm of evidence-based medicine relies on clinical guidelines derived from randomized clinical trials (RCTs), but these guidelines often overlook individual variations in treatment effects. Approaches have been proposed to develop models predicting the effects of individualized management, such as predictive allocation, individualizing treatment allocation. It is currently unknown whether widespread implementation of predictive allocation could result in better population-level outcomes over guideline-based therapy. We sought to simulate the potential effect of predictive allocation using data from previously conducted RCTs. METHODS AND RESULTS: Data from 3 RCTs (positive trial, negative trial, trial stopped for futility) in pediatric cardiology were used in a computational simulation study to quantify the potential benefits of a personalized approach based on predictive allocation. Outcomes were compared when using a universal approach vs predictive allocation where each patient was allocated to the treatment associated with the lowest predicted probability of negative outcome. Compared to results from RCTs, predictive allocation yielded absolute risk reductions of 13.8% (95% confidence interval [CI] -1.9 to 29.5), 13.9% (95% CI 4.5-23.2), and 15.6% (95% CI 1.5-29.6), respectively, corresponding to a number needed to treat of 7.3, 7.2, and 6.4. The net benefit of predictive allocation was directly proportional to the performance of the prediction models and disappeared as model performance degraded below an area under the curve of 0.55. DISCUSSION: These findings highlight that predictive allocation could result in improved group-level outcomes, particularly when highly predictive models are available. These findings will need to be confirmed in simulations of other trials with varying conditions and eventually in RCTs of predictive vs guideline-based treatment allocation.