5-Year haemodynamic performance of three aortic bioprostheses. A randomized clinical trial.

OBJECTIVES: The Carpentier Perimount (CP) Magna Ease, the Crown Phospholipid Reduction Treatment (PRT) and the Trifecta bovine pericardial valves have been widely used worldwide. The primary end point of this study was to compare the haemodynamic performance quantified by in vivo echocardiograms of these 3 aortic prostheses. METHODS: The "BEST-VALVE" (comparison of 3 contemporary cardiac bioprostheses: mid-term valve haemodynamic performance) was a single-centre randomized clinical trial to compare the haemodynamic and clinical outcomes of the aforementioned bioprostheses. The 5-year results are assessed in this manuscript. RESULTS: A total of 154 patients were included. The CP Magna Ease (n = 48, 31.2%), Crown PRT (n = 51, 32.1%) and Trifecta (n = 55, 35.7%) valves were compared. Significant differences were observed among the 3 bioprostheses 5 years after the procedure. The following haemodynamic differences were found between the CP Magna Ease and the Crown PRT bioprostheses [mean aortic gradient: 12.3 mmHg (interquartile range {IQR} 7.8-17.5) for the CP Magna Ease vs 15 mmHg (IQR 10.8-31.9) for the Crown PRT, P < 0.001] and between the CP Magna Ease and the Trifecta prostheses [mean aortic gradient: 12.3 mmHg (IQR 7.8-17.5) for the CP Magna Ease vs 14.7 mmHg (IQR 8.2-55) for the Trifecta, P < 0.001], with a better haemodynamic performance of the CP Magna Ease. The cumulative incidence of severe structural valve degeneration was 9.5% in the Trifecta group at 6 years of follow-up. The 1-, 3- and 5-year survival from all-cause mortality was 91.5%, 83.5% and 74.8%, respectively (log rank P = 0.440). Survival from the composite event at the 1-, 3- and 5-year follow-up was 92.8%, 74.6% and 59%, respectively (log rank P = 0.299). CONCLUSIONS: We detected significant differences between the 3 bioprostheses; the CP Magna Ease had the best haemodynamic performance at the 5-year follow-up.

Co-Management Reduces Mortality in Post-Sternotomy Mediastinitis.

Background: Post-sternotomy mediastinitis (PSM) is one of the most feared complications of cardiac surgery. The impact of a multidisciplinary management approach on this pathology is yet unknown. Patients and Methods: A multidisciplinary approach based on a co-management model (CMM) of care was initiated in January 2018 because of the incorporation of a hospitalist unit on a cardiac surgery department. An observational retrospective cohort study was designed to evaluate the impact of the CMM of care compared to the standard model (SM) of care in patients diagnosed with PSM. Our primary and secondary outcomes were survival time and treatment failure rate (two or more surgical procedures needed to solve PSM or PSM-related death), respectively. Data related to patient death date were collected from the Spanish National Death Index. A multivariable Cox regression model was created using those variables believed to be clinically relevant. Results: Ninety-one patients developed PSM from January 2010 to June 2020. Regarding the pre-operative clinical status, surgical procedure, and PSM severity, both groups had similar baseline characteristics. Patients were followed for a mean of 27.54 ± 30.5 months. A total of 60.3% of the SM group and 11.1% of the CMM group (p < 0.001) died. Treatment failure occurred in 53 patients (72.6%) in the SM group versus 7 (38.6%) in the CMM group (p = 0.007). The CMM independently reduced overall mortality (hazard ratio [HR], 0.11; 95% confidence interval [CI]. 0.01-0.83) and treatment failure rate (HR, 0.01; 95% CI, 0.001-0.183). Gram-positive bacterial infection (HR, 3.73; 95% CI, .6-8.3), and complete osteosynthesis material removal (HR, 0.47; 95% CI, 0.24-0.91) also influenced mortality in our model. Conclusions: A co-management care model reduced overall mortality in patients diagnosed with post-sternotomy mediastinitis.

One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial.

BACKGROUND: We aimed to compare 1 year the hemodynamic in-vivo performance of three biological aortic prostheses (Carpentier Perimount Magna EaseTM, Crown PRTTM, and TrifectaTM). METHODS: The sample used in this study comes from the "BEST-VALVE" clinical trial, which is a phase IV single-blinded randomized clinical trial with the three above-mentioned prostheses. RESULTS: 154 patients were included. Carpentier Perimount Magna EaseTM (n = 48, 31.2%), Crown PRTTM (n = 51, 32.1%) and TrifectaTM (n = 55, 35.7%). One year after the surgery, the mean aortic gradient and the peak aortic velocity was 17.5 (IQR 11.3-26) and 227.1 (IQR 202.0-268.8) for Carpentier Perimount Magna EaseTM, 21.4 (IQR 14.5-26.7) and 237.8 (IQR 195.9-261.9) for Crown PRTTM, and 13 (IQR 9.6-17.8) and 209.7 (IQR 176.5-241.4) for TrifectaTM, respectively. Pairwise comparisons demonstrated improved mean gradients and maximum velocity of TrifectaTM as compared to Crown PRTTM. Among patients with nominal prosthesis sizes ≤ 21, the mean and peak aortic gradient was higher for Crown PRTTM compared with TrifectaTM, and in patients with an aortic annulus measured with metric Hegar dilators less than or equal to 22 mm. CONCLUSIONS: One year after surgery, the three prostheses presented a different hemodynamic performance, being TrifectaTM superior to Crown PRTTM.

Validation of EuroSCORE II on a single-centre 3800 patient cohort.

OBJECTIVES: To compare and validate the new European System for Cardiac Operative Risk Evaluation (EuroSCORE) II with EuroSCORE at our institution. METHODS: The logistic EuroSCORE and EuroSCORE II were calculated on the entire patient cohort undergoing major cardiac surgery at our centre between January 2005 and December 2010. The goodness of fit was compared by means of the Hosmer-Lemeshow (HL) chi-squared test and the area under the curve (AUC) of the receiver operating characteristic curves of both scales applied to the same sample of patients. These analyses were repeated and stratified by the type of surgery. RESULTS: Mortality of 5.66% was observed, with estimated mortalities according to logistic EuroSCORE and EuroSCORE II of 9 and 4.46%, respectively. The AUC for EuroSCORE (0.82, 95% confidence interval [CI] 0.79-0.85) was lower than that for EuroSCORE II (0.85, 95% CI 0.83-0.87) without the differences being statistically significant (P = 0.056). Both scales showed a good discriminative capacity for all the pathologies subgroups. The two scales showed poor calibration in the sample: EuroSCORE (χ(2) = 39.3, P(HL) < 0.001) and EuroSCORE II (χ(2) = 86.69, P(HL) < 0.001). The calibration of EuroSCORE was poor in the groups of patients undergoing coronary (P(HL) = 0.01), valve (P(HL) = 0.01) and combined coronary valve surgery (P(HL) = 0.012); and that of EuroSCORE II in the group of coronary (P(HL) = 0.001) and valve surgery (P(HL) < 0.001) patients. CONCLUSIONS: EuroSCORE II demonstrated good discriminative capacity and poor calibration in the patients undergoing major cardiac surgery at our centre.