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.

Machine-learning approaches for risk prediction in transcatheter aortic valve implantation: Systematic review and meta-analysis.

OBJECTIVES: With the expanding integration of artificial intelligence (AI) and machine learning (ML) into the structural heart domain, numerous ML models have emerged for the prediction of adverse outcomes after transcatheter aortic valve implantation (TAVI). We aim to identify, describe, and critically appraise ML prediction models for adverse outcomes after TAVI. Key objectives consisted in summarizing model performance, evaluating adherence to reporting guidelines, and transparency. METHODS: We searched PubMed, SCOPUS, and Embase through August 2023. We selected published machine learning models predicting TAVI outcomes. Two reviewers independently screened articles, extracted data, and assessed the study quality according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Outcomes included summary C-statistics and model risk of bias assessed with the Prediction Model Risk of Bias Assessment Tool. C-statistics were pooled using a random-effects model. RESULTS: Twenty-one studies (118,153 patients) employing various ML algorithms (76 models) were included in the systematic review. Predictive ability of models varied: 11.8% inadequate (C-statistic <0.60), 26.3% adequate (C-statistic 0.60-0.70), 31.6% acceptable (C-statistic 0.70-0.80), and 30.3% demonstrated excellent (C-statistic >0.80) performance. Meta-analyses revealed excellent predictive performance for early mortality (C-statistic: 0.81; 95% confidence interval [CI], 0.65-0.91), acceptable performance for 1-year mortality (C-statistic: 0.76; 95% CI, 0.67-0.84), and acceptable performance for predicting permanent pacemaker implantation (C-statistic: 0.75; 95% CI, 0.51-0.90). CONCLUSIONS: ML models for TAVI outcomes exhibit adequate-to-excellent performance, suggesting potential clinical utility. We identified concerns in methodology and transparency, emphasizing the need for improved scientific reporting standards.

Midterm Outcomes After Aortic Valve Neocuspidization (Ozaki Procedure) in Adults.

BACKGROUND: Trileaflet aortic valve neocuspidization (AVN) using autologous pericardium (Ozaki procedure) is an emerging surgical treatment option for aortic valve diseases. Although excellent results have been reported from Japan, data pertaining to its use in the United States are sparse. METHODS: All adult patients who underwent AVN (AVN group) or surgical aortic valve replacement (SAVR) with a bioprosthetic valve (SAVR group) between 2015 and 2022 were identified. Propensity score matching was used to adjust the baseline characteristics between the 2 groups. RESULTS: A total of 101 patients underwent AVN, and 1816 patients underwent SAVR with a bioprosthetic valve. None in the AVN group required conversion to SAVR. Before matching, mean age in the AVN group was 68.5 ± 8.8 years, and 56 patients (55.4%) underwent concomitant procedures. Preoperatively, 3 (3%) had endocarditis. Bicuspid valve was observed in 38 (38.4%). None died at 30 days in the AVN group. The median follow-up duration was 3.2 years. After propensity score matching, the expected survival and freedom from at least moderate aortic regurgitation at 5 years was 91.7% ± 3.1% and 97.6% ± 1.7%, respectively. Propensity score matching yielded 77 patients in each group. The Kaplan-Meier curve demonstrated equivalent survival at 5 years between the 2 groups (P = .95). Additionally, freedom from at least moderate aortic regurgitation was comparable at 5 years (P = .23). CONCLUSIONS: AVN can be safely performed for a variety of aortic valve diseases, with or without concomitant operations. AVN demonstrated similar midterm outcomes compared with SAVR with a bioprosthetic valve in the United States adult population.

Hemocompatibility Evaluation of a Novel Ambulatory Pulmonary Assist System Using a Lightweight Axial-Flow Pump.

The Pulmonary Assist System (PAS) is currently under development as a wearable respiratory assist system. In this study, the hemocompatibility of the PAS's axial-flow mechanical pump (AFP) was compared to other contemporary mechanical pumps in an acute ovine model. The PAS was attached to a normal sheep in a venovenous configuration using one of three pumps: 1) AFP, 2) ReliantHeart HeartAssist 5 (control), or 3) Abbott Pedimag (control) (n = 5 each). Each sheep was supported on the PAS for 12 hours with two L/minute of blood flow and four L/minute of sweep gas. Hemolysis, coagulation, inflammation, and platelet activation and loss were compared among the groups. In this study, the plasma-free hemoglobin (pfHb) was less than 10 mg/dl in all groups. The pfHb was significantly lower in the AFP group compared to other groups. There was no significant clot formation in the pumps and oxygenators in all groups. Furthermore, no significant differences in coagulation (oxygenator resistance, fibrinopeptide A), inflammation (white blood cell counts, IL-8), and platelet activation and loss (p-selectin, platelet counts) were observed among the groups (all, p > 0.05). This study demonstrates equivalent hemocompatibility of the PAS's AFP to other contemporary mechanical pumps with a reduced level of hemolysis on startup.