Bart Josephus Johannes Velders

A recent discussion that highlighted the differences between the reported effective orifice area and corresponding incidence of prosthesis-patient mismatch within the 1- and 7-year results of the PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Trial of the Avalus valve has once again emphasized the instability of such measurements. The effective orifice area, calculated using the continuity equation through measurements of the left ventricular outflow tract diameter, is highly susceptible to measurement variability, as previously demonstrated in literature through both intra- and interobserver variability. To illustrate this problem, a simulation was performed in which the left ventricular outflow tract diameter was systematically altered by −2 mm, −1 mm, 0 mm, +1 mm, and +2 mm. Subsequently, the proportion of severe prosthesis-patient mismatch was recalculated and varied between 13.3%, 6.2%, 3.1% (original), 1.2%, and 0.3%, respectively. These findings demonstrate that small but clinically realistic variability in left ventricular outflow tract measurements can significantly affect the presence of prosthesis-patient mismatch. A measurement variability of 1 mm can nearly double or halve the prevalence of severe prosthesis-patient mismatch. This illustrates that prosthesis-patient mismatch, in its current form, is highly unstable and that indexed effective orifice area-based prosthesis-patient mismatch should not be used in isolation.

Background Randomised controlled trials (RCTs) comparing transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) have significantly influenced treatment guidelines for aortic stenosis, expanding the use of TAVI into lower risk populations. However, the patients enrolled in the SAVR arms of these trials may differ from those typically undergoing SAVR in routine clinical practice. This study aims to critically assess the representativeness of SAVR patients in these RCTs by comparing their characteristics and outcomes to those of patients undergoing SAVR in routine clinical practice. Methods A systematic literature review was conducted across PubMed, Embase, Web of Science, Emcare and the Cochrane Library, focusing on RCTs and large prospective studies (n≥500 SAVR patients), enrolling low-risk or intermediate-risk patients since 2010. Patient characteristics, early outcomes and 5-year survival were compared between RCT SAVR cohorts and those treated in routine clinical practice settings. Meta-analyses of pooled data and reconstructed Kaplan-Meier survival analyses were performed, with stratification by risk category. Results Nineteen studies (9 RCTs and 10 studies describing routine clinical practice), encompassing 74 797 SAVR patients, were included. SAVR patients in routine clinical practice demonstrated comparable early mortality to SAVR patients in RCTs but experienced fewer periprocedural complications, including lower rates of stroke, pacemaker implantation and myocardial infarction. At 5 years, overall survival was notably higher in patients treated in routine clinical practice compared to those in the SAVR arms of RCTs, both for low-risk (HR 0.64, 95% CI 0.55 to 0.75) and intermediate-risk patients (HR 0.55, 95% CI 0.470.64). Conclusions Compared with typical SAVR patients treated in routine practice, RCT SAVR patients experienced higher complication rates and worse long-term survival, despite similar or lower surgical risk scores. These findings question the external validity of SAVR versus TAVI trials.

Trials in cardiac surgery are often hampered at the design level by small sample sizes and ethical considerations. The conventional analytical approach, combining frequentist statistics with null hypothesis significance testing, has known limitations and its associated P-values are often misinterpreted, leading to dichotomous conclusions of trial results. The Bayesian statistical framework may overcome these limitations through probabilistic reasoning and is subsequently introduced in this Primer. The Bayesian framework combines prior beliefs and currently obtained data (the likelihood), resulting in updated beliefs, also known as posterior distributions. These distributions subsequently facilitate probabilistic interpretations. Several previous cardiac surgery trials have been performed under a Bayesian framework and this Primer enhances the understanding of their basic concepts by linking results to graphical presentations. Furthermore, contemporary trials that were initially analysed under a frequentist framework, are re-analysed within a Bayesian framework to demonstrate several interpretative advantages.

OBJECTIVES: To describe the nationwide survival outcomes after surgery for type-A dissection (TAAD). METHODS: All patients who underwent surgery for TAAD in the Netherlands between 2018 and 2021 were identified in the Netherlands Heart Registration (NHR) database. The NHR data were linked to lifelong survival data from Statistics Netherlands (98% match). Time trends for in-hospital and mid-term mortality were described, and age- and sex-adjusted regression analysis was performed. The cause and location of death were reported and stratified according to survival time intervals. RESULTS: The study population consisted of 1317 patients with a mean age of 63.1 years (11.8). The number of surgeries increased from 284 in 2018 to 375 in 2021. The surgery included the ascending aorta in 99%, aortic arch in 73%, aortic root in 32.5% and the descending aorta in 5% of cases. In-hospital mortality decreased from 20.4% in 2018 to 13.9% (95% CI) in 2021. A total of 318 deaths were recorded and the majority (70%) of patients died from the consequences of their dissection. However, among 365-day survivors, only 14% died related to their dissection, while 37% of deaths were related to cardiovascular disease and 17% to cancer. The majority (84%) of patients died in the hospital but deaths after 365 days occurred most frequently (37%) at home. CONCLUSIONS: Over the recent years, the number of surgeries for type-A dissections in the Netherlands has increased and in-hospital mortality has decreased. For patients surviving one year after surgery, the main cause of death was not dissection, but other causes such as cardiovascular disease or cancer.

Background: Insights into quantitative differences between core laboratory and center‐reported echocardiographic assessment of the native and bioprosthetic aortic valve are lacking. We aimed to explore clinically relevant differences between these evaluations.Methods: Data were used from the PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Pivotal Trial for the Avalus valve. In this trial, patients with an indication for surgical aortic valve replacement (SAVR) due to aortic stenosis or regurgitation (AR) were enrolled. Serial echocardiographic examinations were performed at each center and blindly reanalyzed by an independent echocardiographic core laboratory (ECL). For the bioprosthetic valve analysis, postoperative data throughout the 5‐year follow‐up were pooled. Differences between the ECL and the centers in continuous parameters were quantified in mean differences and intraclass correlation coefficients (ICCs). Agreement on AR, paravalvular leak (PVL), and prosthesis‐patient mismatch (PPM) classification was investigated using Cohen's kappa coefficients.Results: The analysis on the native aortic valve was performed on 1118 echocardiograms. The relative mean difference was largest for the left ventricular outflow tract (LVOT) area, followed by stroke volume and effective orifice area (index), with center‐reported values being 11%–7% higher. High ICCs of around 0.90 were observed for the parameters peak aortic jet velocity, mean pressure gradient, and the velocity‐time integral across the aortic valve. Over 5000 echocardiograms were available for the bioprosthetic valve analysis. Therein, comparable results were observed. The kappa coefficient was 0.59 (95% confidence interval [CI] 0.56, 0.63) for agreement on native AR, 0.28 (95% CI 0.18, 0.37) for PVL, and 0.42 (95% CI 0.40, 0.44) for PPM.Conclusions: There is high agreement between the ECL and clinical centers on continuous‐wave Doppler‐related measurements. In contrast, agreement is low for parameters that involve measurement of the LVOT diameter. These results provide important context for the interpretation of aortic valve performance in studies that lack central ECL evaluation.Trial Registration: ClinicalTrials.gov identifier: NCT02088554

Background Significant secondary mitral regurgitation (SMR) is known to be associated with worse prognosis. However, data focusing specifically on moderate SMR and associated risk factors are lacking. In the present study, clinical and echocardiographic parameters associated with outcomes were evaluated in a large cohort of patients with moderate SMR. Methods Patients with moderate SMR were retrospectively included and stratified by New York Heart Association (NYHA) class and specific aetiology (atrial SMR (aSMR) or ventricular SMR (vSMR)) with a further classification of vSMR based on left ventricular ejection fraction (LVEF) ≥40% or Results Of the total 1061 patients with moderate SMR (age 69±11 years, 59% male) included, 854 (80%) were in NYHA class I−II and 207 (20%) were in NYHA class III−IV. Regarding the aetiology, 352 (33%) had aSMR and 709 (67%) had vSMR, of which 329 (46%) had LVEF ≥40% and 380 (54%) had LVEF Conclusion In patients with moderate SMR, distinction in SMR aetiology and assessment of symptoms are important independent determinants of outcome.