Valve‐in‐valve (ViV) procedures have emerged from an off‐label procedure to a safe and efficient alternative to redo aortic valve replacement in the treatment of symptomatic structural valve ...deterioration (SVD). During ViV procedures, optimal placement of the transcatheter heart valve (THV) inside the degenerated bioprosthesis is of paramount importance regarding complications such as device embolization, coronary obstruction, periprosthetic regurgitation, residual gradients, and mitral valve injury, but also for the attainment of optimal hemodynamics. In the case of the Mosaic (Medtronic, Minneapolis, MN) valve, the limited radiopaque landmarks represent a challenge to a reproducible, optimal implantation. Such implantation may require multiple contrast injections and transesophageal echocardiogram (TEE) guidance. We herein describe a computer‐assisted ViV procedure inside a deteriorated Mosaic valve, achieving reproducible optimal placement using a preacquired library of bioprostheses 3D models. Our approach suggests an evolving paradigm in ViV procedures, from safe and efficient toward optimal therapy for symptomatic SVD.
The aim of this study using decision curve analysis (DCA) was to evaluate the clinical utility of a deep-learning mortality prediction model for cardiac surgery decision making compared with the ...European System for Cardiac Operative Risk Evaluation (EuroSCORE) II and to 2 machine-learning models.
Using data from a French prospective database, this retrospective study evaluated all patients who underwent cardiac surgery in 43 hospital centers between January 2012 and December 2020. A receiver operating characteristic analysis was performed to compare the accuracy of the EuroSCORE II, machine-learning models, and an adapted Tabular Bidirectional Encoder Representations from Transformers deep-learning model in predicting postoperative in-hospital mortality. The clinical utility of these models for cardiac surgery decision making was compared using DCA.
Over the study period, 165,640 patients underwent cardiac surgery, with a mean EuroSCORE II of 3.99 ± 6.67%. In the receiver operating characteristic analysis, the area under the curve was significantly greater for the deep-learning model (0.834; 95% confidence interval, 0.831-0.838) than the EuroSCORE II (P < .001), the random forest model (P = .03), and the Extreme Gradient Boosting model (P = .03). In the DCA, the clinical utility of the 3 artificial intelligence models was superior to that of the EuroSCORE II, especially when the threshold probability of death was high (>45%). The deep-learning model showed the greatest advantage over the EuroSCORE II.
The deep-learning model had better predictive accuracy and greater clinical utility than the EuroSCORE II and the 2 machine-learning models. These findings suggest that deep learning with Tabular Bidirectional Encoder Representations from Transformers prediction model could be used in the future as the gold standard for cardiac surgery decision making.
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OBJECTIVESUsing French transcatheter aortic valve replacement (TAVR) registries linked with the nationwide administrative databases, the study compared the rates of long-term mortality, bleeding, and ...ischemic events after TAVR in patients requiring oral anticoagulation with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). BACKGROUNDThe choice of optimal drug for anticoagulation after TAVR remains debated. METHODSData from the France-TAVI and FRANCE-2 registries were linked to the French national health single-payer claims database, from 2010 to 2017. Propensity score matching was used to reduce treatment-selection bias. Two primary endpoints were death from any cause (efficacy) and major bleeding (safety). RESULTSA total of 24,581 patients who underwent TAVR were included and 8,962 (36.4%) were treated with OAC. Among anticoagulated patients, 2,180 (24.3%) were on DOACs. After propensity matching, at 3 years, mortality (hazard ratio HR: 1.37; 95% confidence interval CI: 1.12-1.67; P < 0.005) and major bleeding including hemorrhagic stroke (HR: 1.64; 95% CI: 1.17-2.29; P < 0.005) were lower in patients on DOACs compared with those on VKAs. The rates of ischemic stroke (HR: 1.32; 95% CI: 0.81-2.15; P = 0.27) and acute coronary syndrome (HR: 1.17; 95% CI: 0.68-1.99; P = 0.57) did not differ among groups. CONCLUSIONSIn these large multicenter French TAVR registries with an exhaustive clinical follow-up, the long-term mortality and major bleeding were lower with DOACs than VKAs at discharge. The present study supports preferential use of DOACs rather than VKAs in patients requiring oral anticoagulation therapy after TAVR.
Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics ...and clinical outcomes over time are limited.
The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period.
TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers.
A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation EuroSCORE: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased.
The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter FRANCE TAVI; NCT01777828).
Abstract Objective To clarify the mid-term durability of the Trifecta bioprosthesis for aortic valve replacement (AVR). Methods We retrospectively analyzed the prospectively collected data of 824 ...consecutive implants of the Trifecta valve at a single institution. A 100% complete follow-up was available (average duration, 2.2 ± 1.3 years; range, 0.03-6.9 years; 1747.6 patient-years). Echocardiography data at discharge were recorded prospectively. Results Operative mortality was 3.8%; 2.7% in patients receiving isolated AVR. There were 5 valve-related early reoperations, including 1 for infective prosthetic endocarditis and 4 for nonstructural valve dysfunction. The global rate of severe patient–prosthesis mismatch was 1.26%. Overall 5-year survival was 74.9%, and freedom from valve-related death was 97.8%. The majority of deaths attributed to the valve were due to unknown causes. We observed 6 SVD events at 3.4 ± 1.6 years after surgery. At 5 years, the actuarial freedom from SVD was 98% ± 0.9% (n = 6), freedom from reintervention for SVD was 98% ± 0.9% (n = 5, including 2 transcatheter valve-in-valve), and freedom from open reoperation for SVD was 98.9% ± 0.6%. The 5-year freedom from prosthetic endocarditis was 97.7% ± 0.7% (n = 12, 6 requiring reoperation). There was 1 case of late NSVD (5-year freedom, 99.8% ± 0.2%). Freedom from hemorrhagic events was 98.6% ± 0.5% (86% occurring in patients on anticoagulants); there were no thromboembolic events at follow-up. Conclusions The Trifecta bioprosthesis is a reliable device for AVR. We confirm excellent immediate hemodynamic properties and a very low rate of patient–prosthesis mismatch. The absolute number of SVD cases observed remains limited; nevertheless, their timing, pathological characteristics, and clinical presentation mandate continued follow-up.
Hospital-acquired infections have been associated with significant morbidity and mortality in critically ill surgical patients. However, little is known about mortality due to hospital-acquired ...infections in cardiac surgery.
We conducted a retrospective analysis of prospectively collected data from the cardiac surgery unit of a university hospital. All patients who underwent cardiac surgery over a 7-year period were included. Patients with hospital-acquired infections were matched 1:1 with patients with nonhospital-acquired infections based on risk factors for hospital-acquired infections and death after cardiac surgery using propensity score matching. We performed a competitive risk analysis to study the mortality fraction due to hospital-acquired infections.
Of 8853 patients who underwent cardiac surgery, 370 (4.2%) developed 500 postoperative infections (incidence density rate 4.2 hospital-acquired infections per 1000 patient-days). Crude hospital mortality was significantly higher in patients with hospital-acquired infections than in matched patients who did not develop hospital-acquired infections, 15.4% and 5.7%, respectively (P < .001). The in-hospital mortality fraction due to hospital-acquired infections in our cohort was 17.1% (12.3%-22.8%). Pseudomonas aeruginosa infection (hazard ratio, 2.09; 95% confidence interval, 1.23-3.49; P = .005), bloodstream infection (hazard ratio, 2.08; 95% confidence interval, 1.19-3.63; P = .010), and pneumonia (hazard ratio, 1.68; 95% confidence interval, 1.02-2.77; P = .04) were each independently associated with increased hospital mortality.
Although hospital-acquired infections are relatively uncommon after cardiac surgery (4.2%), these infections have a major impact on postoperative mortality (attributable mortality fraction, 17.1%).
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