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.

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.

Retrospective cohort analysis of Spanish national trends of coronary artery bypass grafting and percutaneous coronary intervention from 1998 to 2017.

INTRODUCTION: Spain is one of the countries with the lowest rates of revascularisation and highest ratio of percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG). OBJECTIVES: To investigate the changes and trends in the two revascularisation procedures between 1998 and 2017 in Spain. DESIGN: Retrospective cohort study. Analysis of in-hospital outcomes. SETTING: Minimum basic data set from the Spanish National Department of Health: mandatory database collecting information of patients who are attended in the Spanish public National Health System. PARTICIPANTS: 603 976 patients who underwent isolated CABG or PCI in the Spanish National Health System. The study period was divided in four 5-year intervals. Patients with acute myocardial infarction on admission were excluded. PRIMARY AND SECONDARY OUTCOMES: We investigated the volume of procedures nationwide, the changes of the risk profile of patients and in-hospital mortality of both techniques. RESULTS: We observed a 2.2-fold increase in the rate of any type of myocardial revascularisation per million inhabitants-year: 357 (1998) to 776 (2017). 93 682 (15.5%) had a coronary surgery. PCI to CABG ratio rose from 2.2 (1998-2002) to 8.1 (2013-2017). Charlson's index increased by 0.8 for CABG and 1 for PCI. The median annual volume of PCI/hospital augmented from 136 to 232, while the volume of CABG was reduced from 137 to 74. In the two decades, we detected a significant reduction of CABG in-hospital mortality (6.5% vs 2.6%, p<0.001) and a small increase in PCI (1.2% vs 1.5%, p<0.001). Risk adjusted mortality rate was reduced for both CABG (1.51 vs 0.48, p<0.001), and PCI (1.42 vs 1.05, p<0.001). CONCLUSION: We detected a significant increase in the volume of revascularisations (particularly PCI) in Spain. Risk-adjusted in-hospital mortality was significantly reduced.

Isolated aortic valve replacement in Spain: national trends in risks, valve types, and mortality from 1998 to 2017.

INTRODUCTION AND OBJECTIVES: To help to illustrate the trends in isolated surgical aortic valve replacement (SAVR) in Spain, we performed a national-level analysis to investigate the changes from 1998 to 2017 in a) SAVR volume, b) patients' risk profiles, c) in-hospital mortality, and d) types of aortic valve prostheses. METHODS: We included all episodes of patients undergoing isolated SAVR from January 1998 to December 2017 recorded in the Minimum Basic Data Set (Ministry of Health, Consumer Affairs, and Social Welfare, Spain). The study duration was divided into four 5-year periods. We analyzed the trends in SAVR volume, comorbidity prevalence, and in-hospital mortality. Through multivariate logistic regression, we identified factors associated with mortality and type of prosthesis. The risk-adjusted mortality rate was compared over the study period. RESULTS: In total, 73 668 patients underwent an isolated SAVR from 1998 to 2017. The annual volume of procedures increased from 16 363 between 1998 and 2002 to 22 685 between 2013 and 2017. The prevalence of all investigated comorbidities increased, except for history of previous myocardial infarction and unplanned admission. The Charlson comorbidity index worsened from 1998-2002 (2.3; SD, 1.4) to 2013-2017 (3.6; SD, 1.7) (P <.001). In-hospital mortality decreased from 7.2% to 3.3% (P <.001) while the risk-adjusted mortality index improved from 1.3 to 0.7. The proportion of bioprostheses increased from 20.7% (1998-2002) to 59.6% (2013-2017) (P <.001). CONCLUSIONS: We detected an increase in the annual SAVR volume in Spain, with more patients receiving bioprostheses. Despite an increased risk profile of the patients, in-hospital mortality substantially reduced.

Combined off-pump mitral repair and thoracoscopic maze surgery.

A 67-year-old man with severe mitral regurgitation and paroxysmal atrial fibrillation was admitted to our institution for surgical repair. The procedure was carried out off-pump. We first performed a totally thoracoscopic maze box lesion set with epicardial transmural radiofrequency, and clipped the left atrial appendage. The mitral valve prolapse was repaired by implanting three transapical neochordae. Six months later, the patient was in sinus rhythm with minimal residual mitral regurgitation on echocardiography. This novel approach is less invasive than the standard surgical correction and should ensure a faster recovery with similar safety and efficacy in selected cases.

Early surgery for acute-onset infective endocarditis.

OBJECTIVES: Acute onset of infective endocarditis has been previously linked to the development of septic shock and a worse prognosis. The purpose of this study was to analyse the clinical features and in-hospital evolution of patients with acute-onset endocarditis as well as the potential role of early surgery in the treatment of these patients. METHODS: From 1996 to 2014, 1053 consecutive patients with left-sided endocarditis were prospectively included. Patients were classified into 2 groups according to the clinical presentation: patients with acute-onset endocarditis (n = 491) and patients with non-acute endocarditis (n = 562). Acute-onset endocarditis was considered when the time between the appearance of symptoms and diagnosis was <15 days. RESULTS: At admission, acute renal failure, septic shock and cerebral embolism predominated among patients with acute-onset endocarditis. Staphylococcus aureus was more frequently isolated in patients with an acute onset (27.7% vs 7.8% P < 0.001). During hospitalization, patients with acute onset developed systemic embolism and septic shock more frequently. Death was much more common in this group (42.7 vs 30.1%, P < 0.001). Paravalvular complications, nosocomial infection, heart failure, S. aureus and septic shock were predictors of mortality. Acute-onset presentation of endocarditis was strongly associated with increased mortality. Among patients with acute-onset endocarditis, early surgery, performed within the first 2 days after diagnosis, was associated with a 64% of reduction in mortality. CONCLUSIONS: Patients with endocarditis and acute onset of symptoms are at high risk of septic in-hospital complications and mortality. Early surgery, performed within the first 2 days after diagnosis, plays a central role in the treatment of these patients.

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.

Transapical aortic valve prosthetic endocarditis.

An 83-year-old patient underwent a transapical aortic valve implantation at our institution. Four months later, she was readmitted to our institution because of fever and heart failure. A prosthetic aortic valve endocarditis was diagnosed. Because of the high surgical risk, surgery was refused and the patient died shortly after the diagnosis. We briefly discuss the implications of this finding in the prevention of infective endocarditis after transcatheter aortic valve implantation.

Short- and mid-term results for aortic valve replacement in octogenarians.

Population over 80 years who require surgery for degenerative aortic stenosis has largely increased in the past decades. We have compared short- and mid-term results for conventional aortic valve replacement (AVR) for calcific-degenerative aortic stenosis in older and younger than 80 years operated at our institution between April 2004 and December 2008. Predictors of mortality and major adverse cardio and cerebrovascular events (MACCEs) on the postoperative and follow-up period were determined through multivariable analysis. Four hundred and fifty-one patients were included in the study. Ninety-four (20.8%) were >or=80. Previous cardiac surgery [odds ratio (OR)=4.08, P=0.047], renal failure (OR=6.75, P<0.001), concomitant coronary artery bypass grafting (CABG) (OR=2.57, P=0.034), female sex (OR=2.49, P=0.047), and severe pulmonary hypertension (OR=3.68, P=0.024) were independent predictors of in-hospital mortality. In the follow-up, age >or=80 years [Hazard ratio (HR)=2.44, P=0.02], high blood pressure (HBP) (HR=5.2, P=0.025) and peripheral arterial disease (PAD) (HR=5.1, P<0.001) were independent predictors for late mortality. Only PAD (HR=3.55, P=0.014) and HBP (HR=8.24, P=0.04) were independent predictors for late cardiac mortality. Renal failure (OR=2.57, P=0.005), severe pulmonary hypertension (OR=3.49, P=0.005) and concomitant CABG (OR=2.49, P=0.002) were independent predictors for postoperative MACCEs. Diabetes mellitus (HR=2.03, P=0.033) and PAD (HR=2.3, P=0.041) were independent predictors for MACCEs in the follow-up. According to these data, we can conclude that conventional open AVR for degenerative aortic stenosis grants good early- and mid-term outcomes in octogenarians in our experience.