Effective Area Index Research Articles

The comparison of echocardiographic and serum parameters between Sapien 3 Ultra Resilia and Sapien 3 at one month

Abstract Background Sapien 3 Ultra Resilia (S3UR) is the latest balloon-expandable valve for transcatheter aortic valve replacement (TAVR). Compared to Sapien 3 (S3), previous model of balloon-expandable valve, the leaflets are modified to anti-calcification tissue and the outer skirt becomes 40% higher with textured polyethylene terephthalate. However, it is unknown how these structural changes affect echocardiographic and serum parameters after TAVR. Purpose To compare impacts of these design changes on relevant echocardiographic and serum parameters between S3UR and S3 in the short term. Methods Patients with severe aortic valve stenosis who underwent TAVR with S3 or S3UR were included in this study. Echocardiographic parameters and blood samples were retrospectively collected at discharge and at 1 month post-procedure. Echocardiographic outcomes included mean pressure gradient (PG), effective orifice area index (EOAi), and paravalvular leak (PVL) grade. Hemolytic anemia indicators, specifically lactate dehydrogenase (LDH) and hemoglobin (Hb), were also assessed. Findings suggestive of hemolytic anemia at 1 month were defined as "an increase in LDH level of ≧200 IU/L as well as a decrease in Hb level of ≧1.0 g/dL from pre-procedure." Results Among 443 patients (S3: April 2020-March 2023, S3UR: April 2023-December 2023), 339 patients (S3: n=270, S3UR: n=69) were available for this study. The mean PG was significantly lower in the S3UR group compared to the S3 group at discharge and at 1 month (Figure 1A). On the other hand, the EOAi was similar between the two groups at discharge and at 1 month (Figure 1B). Although the prevalence of none/trace PVL was significantly higher in the S3UR group at discharge, this difference disappeared at 1 month (Figure 1C). LDH levels were significantly increased from pre-procedure to 1 month in both groups (Figure 2A). The median of ΔLDH (1 month – pre-procedure) and %change of LDH (ΔLDH/ pre-procedure) were significantly higher in the S3UR group. The prevalence of hemolytic anemia at 1 month was also significantly higher in this group (Figure 2B). Conclusion At 1 month, S3UR demonstrated superiority in mean PG but equivalence in EOAi and PVL grade compared with S3. Although both S3UR and S3 showed significant increase in LDH from pre-procedure to 1 month, hemolytic anemia was experienced more frequently in S3UR cases. Further evaluation will be needed to assess the potential clinical impacts of these differences.

Effect of patient prosthesis mismatch on clinical outcomes following surgical aortic valve replacement

Abstract Introduction Patient prosthesis mismatch (PPM) after surgical aortic valve replacement (SAVR) occurs when the valve’s effective orifice area (EOA) does not allow appropriate cardiac output to meet demand, causing increased transvalvular gradients. The literature is conflicting regarding the effect of PPM on long-term mortality and other adverse outcomes. Purpose To characterise the effect of PPM on all-cause mortality, cardiovascular death, heart failure hospitalisation and major adverse cardiac events (MACE; a composite of cardiovascular death, myocardial infarction, and stroke) following SAVR, stratified by sex. Methods This retrospective cohort study uses data from the Western Australia Heart Valves Study linked to administrative health data and includes all patients who underwent SAVR in Western Australian public hospitals between 2010-2020. PPM was defined according to the Valve Academic Research Consortium 3 criteria. The indexed EOA was derived from body surface area and published in-vivo EOA’s calculated for each prosthesis model and size. Results During the study period 1837 patients underwent SAVR (mean age 65 ± SD 14 years, 31% female). Median follow-up was 3.76 years (IQR 1.73-6.62). A mechanical prosthesis was implanted in 579 (32%) patients. Moderate or severe PPM was present in 250 (14%) patients, whilst no significant PPM was present in 1587 (86%) patients. Compared to those without significant PPM, patients with PPM were older (69 ± 14 vs 64 ± 11 years; p<0.001); included more women (101/250; 40% vs 459/1587; 29%; p<0.001) and were more likely to have bioprosthetic SAVR (213/250; 85% vs 1045/1587; 66%; p<0.001). The presence of PPM (moderate or severe vs no significant PPM) was associated with increased all-cause death (Hazard Ratio (HR) 1.74, 95% CI 1.09-2.75), cardiovascular death (HR 2.44, 95% CI 1.33-4.48) and MACE (HR 1.89, 95 CI 1.17-3.04) in females in adjusted analyses, but not males (table). The presence of PPM was not associated with heart failure hospitalisation, overall or in either sex. Conclusion The presence of moderate or severe PPM is associated with increased all-cause death, cardiovascular death, and MACE in females only. These results highlight the importance of patient selection, valve choice and operative technique to minimise PPM, particularly in female patients.Table 1

Core laboratory versus center-reported echocardiographic assessment of the native and bioprosthetic aortic valve

Abstract Background The use of a central echocardiographic core laboratory (ECL) is advised to minimize measurement variation and heterogeneity in clinical trials. Insights into quantitative differences between ECL 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 reanalyzed by an independent ECL. For the bioprosthetic valve analysis, postoperative data throughout 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). Between-center differences were illustrated by plotting standardized mean differences (SMDs) between centers and the ECL for the 10 sites that implanted the most prostheses. 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 patients. 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 (Table 1). High ICCs of around 0.90 were observed for peak aortic jet velocity, mean pressure gradient, and the velocity-time integral across the aortic valve. More than 5000 echocardiograms were available for the bioprosthetic valve analysis. Therein, comparable results were observed. In Figure 1, differences in assessment on center level are illustrated. The SMDs for peak velocity were between 0 and 0.5 for all centers, while there was more heterogeneity between centers for other parameters. 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 For echocardiographic assessment of the native and bioprosthetic aortic valve, agreement between the ECL and the clinical centers varies by parameter and by center. There is high agreement on continuous-wave Doppler-related measurements. On the contrary, 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.

Impact of SAPIEN3 Ultra RESILIA on improvement of valve performance: Insights from the multicenter registry: a propensity-score matched analysis

Abstract Backgrounds: Transcatheter aortic valve implantation (TAVI) is now a cornerstone treatment for symptomatic severe aortic stenosis across all risk profiles, including low-risk and younger patients. As such, the performance and durability of transcatheter heart valves (THVs) are paramount. SAPIEN3 Ultra RESILIA (S3 UR) is expected to improve hemodynamics compared with SAPIEN3 (S3) due to the use of RESILIA bovine pericardial tissue and modified sawing maneuvers for each of three leaflets in 20 and 23mm valves. Aim The aim of study was to evaluate the hemodynamic improvement with S3 UR compared to S3 who underwent TAVI. Methods In a multicenter TAVI registry, we identified 1,931 patients who received a balloon-expandable valve over the past three years. We focused on post-procedural effective orifice area (EOA), post-procedural indexed EOA (EOAi), incidence of prosthesis-patient mismatch (PPM), paravalvular leakage (PVL) and post-procedural mean pressure gradient (mean PG) as our primary endpoints. We preformed propensity score matching analysis using a 1:1 ratio. Parameters including aortic stenosis severity, % oversizing and post dilatation were incorporated into the matching model. Results Of patients, mean age was 84 years old and 37.9% were male. EOAi was significantly larger in S3 UR group than in the S3 group for both cohorts [overall cohort: 1.21 (1.02 – 1.36) vs. 1.08 (0.93 – 1.26), P = 0.001; propensity matched cohort: 1.21 (1.01 – 1.35) vs. 1.11 (0.91 – 1.27), p = 0.042, respectively] (Figure 1). Similarly, the degree of PVL was significantly less in the S3 UR group than in the S3 group for both cohorts. In the propensity matched cohort, mild PVL was identified in 6.5% vs. 14.7%, and moderate PVL was present in 0.0% vs. 1.6% (p = 0.028). Peak PG and mean PG were significantly lower in the S3 UR group than in the S3 group for both cohorts. In the propensity matched cohort, peak PG was 17.7 (14.3 – 24.5) vs. 23.2 (18.2 – 29.2) (p = 0.001) and mean PG was 9.0 (7.1 – 12.5) vs. 11.5 (8.9 -14.8) (p = 0.005), respectively. The incidence of PVL ≥ mild, mean PG ≥ 20 mmHg, moderate PPM and severe PPM were tend to be lower in S3 UR group than in the S3 group for both cohorts (Figure 2). Conclusion The S3 UR valve exhibits significant hemodynamic improvements compared to the S3 valve, underscoring its potential for improved clinical outcomes in TAVI patients.

Flow adjusted predicted prosthesis patient mismatch in patients undergoing transcatheter aortic valve implantation

Abstract Background Effective orifice area (EOA) is flow dependent. However, established methods for the assessment of prosthesis-patient mismatch (PPM) do not consider flow status, and therefore may underestimate the rate and impact of PPM in patients with abnormal flow status. Objectives To investigate the clinical impact of flow-adjusted predicted PPM in patients undergoing transcatheter aortic valve implantation (TAVI). Methods Patients undergoing TAVI in a prospective TAVI registry were stratified by the presence of moderate or severe PPM (EOA index to body surface area [EOAi]: 0.65-0.85 or ≤0.65 and 0.55-0.70 or ≤0.55 cm2/m2 if obese). PPM was defined according to echocardiographically measured EOAi (measured PPM) or unadjusted or flow-adjusted predicted EOAi. Predicted EOAs were based on reference values of EOA for each valve generation and size (predicted PPMTHV) or native aortic annulus dimension (predicted PPMCT). Results Among 1,510 patients included (August 2007-June 2022), rates of moderate or severe PPM differed according to method of assessment; 27.0% and 8.7% according to measured PPM, 11.3% and 1.2% according to predicted PPMTHV, 12.0% and 0.1% according to PPMCT, 21.6% and 0.2% according to flow-adjusted predicted PPMTHV, and 25.1% and 0.4% according to flow-adjusted predicted PPMCT. Five-year mortality was comparable in patients with and without flow-adjusted predicted PPM defined by either method. These results were consistent when patients were stratified by flow status. Conclusions Rates of PPM differ considerably when flow status is considered. There was no consistent signal of increased risk of adverse events up to 5 years in patients with flow-adjusted predicted PPM.Frequency of PPM afteer TAVICumulative event curves for death

Correlations between intraoperative and postoperative echocardiographic measurements in patients undergoing aortic bioprosthetic valve replacement: a prospective observational study.

Patient-prosthesis mismatch (PPM) should be avoided during surgical aortic valve replacement because PPM would worsen the mortality and morbidity. Diagnosis of PPM could be made using various parameters measured by intraoperative transesophageal echocardiography. However, few studies have examined which parameters correlate most accurately between intraoperative and postoperative values. This single-center prospective observational study analyzed 46 patients who underwent surgical aortic valve replacement (SAVR). Echocardiography was performed at the following 3-time points: preoperatively, intraoperatively, and 1month postoperatively. The correlation between intraoperative and postoperative measurement values, including peak velocity (PV), mean pressure gradient (MPG), effective orifice area (EOA), and effective orifice area index (EOAI), were assessed using Pearson's correlation coefficient. Moreover, to evaluate whether a multivariable linear regression model with intraoperative and postoperative stroke volume added as an explanatory variable improves the correlation, the multiple correlation coefficients were calculated. PV, MPG, EOA, and EOAI measured intraoperatively and 1month postoperatively were significantly correlated. The r values of each measurement were 0.35, 0.344, 0.411 and 0.323, respectively. The multivariable linear regression model showed that the multiple correlation coefficients for MG and EOA were 0.491 and 0.663, respectively. Intraoperative and postoperative PV, MPG, EOA, and EOAI were significantly correlated in patients undergoing SAVR with a bioprosthetic valve. The r value for EOA was 0.441, the largest among the measured values. Adjustment for stroke volume improved the strength of the correlation. Intraoperative evaluation of prosthetic valve function was considered most appropriate using EOA. University Hospital Medical Information Network Clinical Trials Registry, registration number UMIN000046164, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052695 .

Determinants of Prosthesis-Patient Mismatch after Aortic Valve Replacement-Ten-Year Cohort Data in Single Center of Taiwan.

Patient-prosthesis mismatch (PPM) after surgical aortic valve replacement for severe aortic stenosis has a significant effect on survival. Few studies have identified the risk factors for PPM and related outcomes. This study investigated these risk factors and clarified the outcomes. This study enrolled consecutive patients who underwent aortic valve replacement surgery between January 2010 and June 2020 in our hospital. Data on clinical profiles, prosthesis types, echocardiographic parameters before and after surgery, and clinical outcomes including the composite of all-cause mortality and redo valve replacement were collected. We defined moderate and severe PPM as an effective orifice area index value of ≤ 0.85 and ≤ 0.65 cm2/m2, respectively, measured postoperatively through echocardiography. Potential risk factors for PPM and clinical outcomes were evaluated. A total of 185 patients were enrolled. Body surface area (BSA; 1.68 ± 0.02 vs. 1.62 ± 0.01 m2, p = 0.036), renal insufficiency (32.50% vs. 11.70%, p = 0.026), and aortic annulus diameter (1.99 ± 0.05 vs. 2.17 ± 0.03 cm, p = 0.013) were statistically significant risk factors for severe PPM. The primary outcome was observed in 30.00% and 15.86% of the patients with and without severe PPM, respectively (log-rank p = 0.023). Multivariate Cox proportional hazards analysis indicated that severe PPM was a risk factor for the primary outcome (hazard ratio: 2.688, 95% confidence interval: 1.094-6.622, p = 0.031). Our study demonstrated that large BSA, renal insufficiency, and small annulus diameter were risk factors for severe PPM after aortic valve replacement surgery. Severe PPM was associated with worse clinical outcomes.

Supra-Annular Versus Intra-Annular Self-Expanding Valves in Small Aortic Annulus: A Propensity Score-Matched Study

BackgroundTranscatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs) may have different outcomes with supra-annular valves (SAVs) or intra-annular valves (IAVs) in patients with small aortic annuli (SAA), but this topic remains underexplored. We aimed to evaluate outcomes between different SEVs, namely SAVs (CoreValve/Evolut R/PRO/PRO+/FX) vs. IAVs (Portico/Navitor). MethodsSingle-center data with patients with SAA (maximum diameter <23 mm) who underwent TAVR from 2013 to 2023 with SEVs, followed by 1:1 propensity score matching (PSM). ResultsWe obtained 86 PSM pairs with median age of 83.0 years (SAVs) and 82.0 years (IAVs), with women representing 77.6% of the PSM cohort. After TAVR, we did not find statistically significant differences for the following outcomes: Valve Academic Research Consortium-3 periprocedural mortality, technical success, device success, clinical efficacy, and rates of paravalvular leak were not statistically significantly different, but we found higher rates of permanent pacemaker implantation in the IAV group (1.2 vs. 8.1%; p = 0.029). Despite the larger indexed effective orifice area with SAVs (median 1.0 vs. 0.8 cm2/m2, p = 0.001), we did not find statistically significant differences between the groups in terms of residual mean gradients >20 mmHg (0.0 vs. 2.3%, p = 0.155), and severe prosthesis-patient mismatch (2.3 vs. 5.8%, p = 0.390). No statistically significant difference was observed in survival (log-rank p = 0.950) and stroke (p = 0.6547) between patients who received SAVs and IAVs. For patients with SAA, TAVR with SEV devices is safe. ConclusionsIAVs and SAVs are associated with comparable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection.

Reducing Left Ventricular Wall Stress through Aortic Valve Enlargement via Transcatheter Aortic Valve Implantation in Severe Aortic Stenosis.

Background: In aortic stenosis, the left ventricle exerts additional force to pump blood through the narrowed aortic valve into the downstream arterial vasculature. Adaptive hypertrophy helps to maintain wall stress homeostasis but at the expense of impaired compliance. Advanced ventricular deformation impacts the extent of functional recovery benefits achieved through transcatheter aortic valve implantation. Methods and Results: Subgroups were stratified based on output, with low-flow severe aortic stenosis defined as stroke volume index <35 mL· m-2. Before intervention, the low-flow subgroup exhibited worse effective orifice area index and arterial and global impedance, along with thinner wall thickness and larger chamber volume marginally. LV performance, including stroke volume index, ventricular elastance, and ventricular-arterial coupling, were notably inferior, consistent with worse adverse remodeling. Although the effective orifice area index was similarly augmented after TAVI, inferior recovery benefits were noted. Persistently higher wall stress and energy consumption were observed, along with poorer ventricular-arterial coupling. These changes in wall stress showed an inverse relationship with alterations in wall thickness and were proportional to changes in dimension and volume. Additionally, they were proportional to changes in left ventricular end-systolic pressure, pressure-volume area, and ventricular-arterial coupling but inversely related to ventricular end-systolic elastance. Conclusions: The study revealed that aortic valve enlargement through transcatheter aortic valve implantation reduces left ventricular wall stress in severe aortic stenosis. The reduced recovery benefits in the low-flow subgroup were evident. Wall stress could serve as a marker of mechanical benefit after the intervention.

Self-expandable transcatheter valve is a potentially useful option for a failing small surgical aortic bioprosthetic valve.

Trans-catheter aortic valve implantation inside a failing surgical aortic valve bio-prosthesis has become an alternative for patients at high risk for redo surgical aortic valve replacement. However, the correlation between the size of the failing surgical aortic valve and the occurrence of prosthesis-patient mismatch after trans-catheter implantation is still controversial. The aim of this study is to analyze and report the results in Japanese patients. Thirty patients who underwent trans-catheter aortic valve implantation inside a failing surgical aortic valve at our hospital were retrospectively reviewed with results from echocardiography and computed tomography. The patients' mean age was 84.5 ± 4.8years. The mean body surface area was 1.42 ± 0.13 m2. The cohort was divided into two groups according to the size of the failing bio-prosthesis: small (≦19mm) and large (> 19mm). There were no significant differences in mean pressure gradient (12.2 ± 4.0mmHg vs. 11.1 ± 1.2mmHg; p = 0.54) and effective orifice area index (1.00 ± 0.26cm2/m2 vs. 0.99 ± 0.25cm2/m2; p = 0.92) between the groups at 6months after trans-catheter implantation. The incidence of moderate (38.5% vs. 28.6%; p = 0.59) and severe (0% vs. 7.1%; p = 0.33) prosthesis-patient mismatch was equivalent. There was no significant difference in survival between the two groups (log-rank test p-value = 0.08). Trans-catheter implantation inside a failing small aortic valve did not increase the frequency of prosthesis-patient mismatch in this Japanese cohort.

MID-TERM ECHOCARDIOGRAPHIC OUTCOMES OF AORTIC VALVE REPLACEMENT USING AUTOLOGOUS PERICARDIUM

Highlights:The mid-term echocardiographic outcomes of aortic valve replacement with autologous pericardium presented in the literature are limited to the basic parameters related to transvalvular hemodynamics;This study is the first in the world to conduct a comprehensive detailed analysis of echocardiographic parameters after neocuspidization using autologous pericardium, both in comparison with standard replacement and between different age populations;Aortic valve neocuspidization using autologous pericardium adult patients of any age group in comparison with mechanical replacement in the mid-term period is characterized by a higher effective orifice area, significant dynamics of left ventricular myocardial mass regression, low potential for the preservation of significant mitral regurgitation. AbstractAim. To analyze echocardiographic parameters after aortic valve replacement using autologous pericardium in various age groups of the adult population.Methods. The multicenter prospective non-randomized cross-controlled study included 71 patients evaluated after surgical correction of aortic valve (AV) stenosis in the mid-term. The population (n = 71) is divided into the following populations: 1 – AVNeo Y (n = 24) – patients aged 19 to 50 years who underwent neocuspidization using autologous pericardium; 2 – AVNeo A (n = 23) – patients aged 51 to 79 years who underwent neocuspidization using autologous pericardium; Group 3 – AVR (n = 24) are patients aged 26 to 50 years who have undergone mechanical replacement. The end points were as follows: index of effective orifice area (EOA), left ventricular mass index (LVMI), peak gradient on AV, peak velocity on AV, pulmonary hypertension (PH), frequency of significant mitral regurgitation (MR), end-diastolic LV volume, LV ejection fraction.Results. In the group 3 (AVR), the lowest EOA index was noted in comparison with the group 1 (AVNeo Y) (p &lt; 0.01) and the group 2 (AVNeo A) (p = 0.02). Significant dynamics of LVMI decrease was observed in groups 1 (AVNeo Y) (p &lt; 0.01) and 2 (AVNeo A) (p &lt; 0.01). In the group 3 (AVR), there was also a decrease in the LVMI in the mid-term, but it went beyond the limits of reliability (p = 0.07). The peak gradient between the groups in the mid-term period was 8.5±2.7 mmHg in the group 1 (AVNeo Y), 8.5±2.6 mmHg in the group 2 (AVNeo A) and 15.6±4.1 mmHg in the group 3 (AVR) (p &lt; 0.01). With respect to significant MR, there was a significant increase in its frequency in the group 3 (AVR) in comparison with other groups (p &lt; 0.01). Moreover, in the group 3 (AVR), a more frequent occurrence of PH was noted in comparison with the group 1 (AVNeo Y) (p &lt; 0.01).Conclusions. AV mechanical replacement in young patients in comparison with neocuspidization using autologous pericardium in adult patients of any age in the mid-term period is characterized by a lower EOA index, the absence of significant dynamics of LVMI regression, a higher peak transvalvular gradient, and a high potential to preserve significant MR and PH.

Patient-Prosthesis Mismatch After Surgical Aortic Valve Replacement: Analysis of the PARTNER Trials

BackgroundOur objective was to compare the impact of patient-prosthesis mismatch (PPM) for 2 years after surgical aortic valve replacement within the prospective, randomized Placement of Aortic Transcatheter Valves (PARTNER) trials. MethodsSurgical aortic valve replacement patients from the PARTNER 1, 2, and 3 trials were included. PPM was classified as moderate (indexed effective orifice area ≤0.85 cm2/m2) or severe (indexed effective orifice area ≤0.65 cm2/m2). The primary endpoint was the composite of all-cause death and heart failure rehospitalization at 2 years. ResultsBy the predicted PPM method (PPMP), 59.1% had no PPM, 38.8% moderate PPM, and 2.1% severe PPM; whereas by the measured PPM method (PPMM), 42.4% had no PPM, 36.0% moderate, and 21.6% severe. Patients with no PPMP (23.6%) had a lower rate of the primary endpoint compared with patients with moderate (28.2%, P = .03) or severe PPMP (38.8%, P = .02). Using the PPMM method, there was no difference between the no (17.7%) and moderate PPMM groups (21.1%) in the primary outcome (P = .16). However, those with no PPMM or moderate PPMM were improved compared with severe PPMM (27.4%, P < .001 and P = .02, respectively). ConclusionsSevere PPM analyzed by PPMP was only 2.1% for surgical aortic valve replacement patients. The PPMM method overestimated the incidence of severe PPM relative to PPMP, but was also associated with worse outcome. There was higher all-cause mortality in patients with severe PPM, thus surgical techniques to minimize PPM remain critical.

Temporal changes in biomarker levels and their association with the early degeneration stage of transcatheter aortic valves in 18F-fluorodeoxyglucose and 18F-sodium fluoride positron emission tomography studies.

As transcatheter aortic valve implantation (TAVI) indications expand, understanding the valve degeneration process and potential influencing biomarkers becomes increasingly important. To investigate temporal changes in biomarker levels and their potential association with 18F-fluorodeoxyglucose (18F-FDG) and 18F-sodium fluoride (18F-NaF) uptake, assessed using positron emission tomography/computed tomography (PET/CT) studies as markers for native aortic annulus calcifications and early-stage TAVI valve degeneration. A total of 71 TAVI patients underwent blood sampling and transthoracic echocardiography at baseline (pre-TAVI) and 6, 12, 18, and 24 months after the procedure. PET/CT using 18F-NaF and 18F-FDG was performed at 6 and 24 months. Serum levels of matrix metalloproteinase-3 (MMP-3), matrix metalloproteinase-9 (MMP-9), and osteopontin (OPN) were measured. In addition, plasma levels of osteoprotegerin (OPG), lipoprotein a (Lp(a)), and oxidized LDL (ox-LDL) were assessed. Finally, 31 patients (median age: 84.0 years) completed the study. Valve function improved after TAVI and remained stable during follow-up. Over 24 months, OPN levels decreased (p = 0.010), while MMP-3 and MMP-9 levels increased (p = 0.046 and p = 0.041). MMP-3 and MMP-9 showed multiple positive correlations across time points. OPN, ox-LDL, and OPG demonstrated significant negative correlations with follow-up effective orifice area index and effective orifice area (EOA). No significant correlations were found between biomarkers and PET/CT uptake. Significant biomarker changes over 24 months and negative correlations with EOA suggest potential roles in aortic valve function. However, no correlations between biomarkers and PET/CT results were observed.

Effect of Elevated Body Mass Index on Outcomes of Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis.

The association of body mass index (BMI) and an "obesity paradox" with cardiovascular risk prediction is controversial. This study aimed to evaluate the impact of elevated BMI on the outcome of transcatheter aortic valve replacement (TAVR) for aortic stenosis. This retrospective study included 1019 patients with a BMI of ≥18.5 kg/m2 divided into 3 groups: 1) normal BMI (18.5-24.9 kg/m2), 2) overweight (25-29.9 kg/m2), and 3) obese (≥30 kg/m2). Propensity score matching was used to compare normal BMI with overweight and normal BMI with obese. The median age of the cohort was 82 years, and 348 patients had a normal BMI, while 319 and 352 patients were overweight and obese, respectively. After 1 : 1 propensity score matching, 258 and 192 pairs between normal BMI and overweight, and normal BMI and obese patients, respectively, were analyzed. Both overweight and obese patients had higher post-transaortic mean gradients and lower indexed effective orifice areas compared to normal BMI patients. During a median follow-up of 25 (range: 0.1-72) months, all-cause mortality was similar between overweight or obese patients and patients with a normal BMI. However, in a subgroup analysis of patients with moderate/severe chronic lung disease, all-cause mortality was significantly higher in obese patients compared with normal BMI patients (hazard ratio = 3.49, 95% confidence interval, 1.21-10.0, P = .021). In this study, the "obesity paradox" was not observed in patients undergoing TAVR; rather, in patients with significant lung disease, obesity may be associated with worse midterm outcomes after TAVR.

Three-year outcomes of surgical valve replacement with Dafodil™ pericardial bioprosthesis: Dafodil™-1 trial.

The Dafodil™-1 trial was designed to evaluate the clinical safety and performance of Dafodil™ pericardial bioprosthesis for replacing diseased native or prosthetic aortic or mitral valves in patients with advanced valvular heart disease (VHD). The Dafodil™-1 trial was a prospective, multicenter, first-in-human clinical trial. Patients were enrolled if they had advanced VHD requiring aortic valve replacement (AVR) or mitral valve replacement (MVR) with or without concomitant valve surgery and having surgical risk scores <4%. Major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI), and stroke; and hemodynamics were analyzed. A total of 136 patients (aortic: 67 and mitral: 69) were enrolled in the trial (with mean age-AVR group: 60.2 ± 8.3 years and MVR group: 49.7 ± 14.4 years). A total of 134 patients (aortic: 66 and mitral: 68) completed the 3-year follow-up (total 300 per 100 patient-years of follow-up). The AVR group demonstrated a significant reduction in the mean pressure gradients from 51.2 ± 24.1 mmHg at baseline to 11.1 ± 6.0 mmHg at the 3-year follow-up (p < 0.0001). The mean effective orifice area (EOA) improved from baseline (0.9 ± 0.6 cm2) to 3-year follow-up (1.8 ± 0.4 cm2) (p < 0.0001). In the MVR group, the mean indexed EOA (iEOA) increased significantly from baseline (0.7 ± 0.4 cm2/m2) to 3-year follow-up (1.1 ± 0.4 cm2/m2) (p < 0.001). There was significant improvement in New York Heart Association functional class and mean SF-12 scores in both groups. At 3-year follow-up, the MACE incidence was 2.3% per 100 patient-years (1.3% strokes per 100 patient-years and 1.3% deaths per 100 patient-years) for AVR group and 4.7% per 100 patient-years (0.6% strokes per 100 patient-years and 4.0% deaths per 100 patient-years) for MVR group. No cases of MI, structural valve deterioration and prosthetic valve endocarditis were reported. The AVR and MVR groups achieved 89.6% and 79.7% MACE-free survival, respectively at 3-year follow-up. The Dafodil™-1 trial demonstrated satisfactory outcomes of clinical safety, hemodynamic performance, and quality-of-life metrics. Additionally, no incidence of structural valve deterioration and very low rates of valve thrombosis during the 3-year follow-up period of Dafodil™-1 first-in-human trial indicated acceptable valve durability up to three years and similar outcomes are warranted for longer follow-ups as a primary goal. https://www.ctri.nic.in/Clinicaltrials/showallp.php?mid1=18377&EncHid=&userName=CTRI/2017/07/009008, CTRI/2017/07/009008.

A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves.

This randomized controlled trial was designed to compare 1-year hemodynamic performances and clinical outcomes after aortic valve replacement (AVR) using a recently introduced (the AVALUS group) and worldwide used (the CEPME group) bovine pericardial bioprostheses. Patients were screened to enroll 70 patients in each group based on a noninferiority design. The primary endpoint of the trial was the mean pressure gradient across the aortic valve (AVMPG) at 1 year after surgery. One-year echocardiographic data were obtained from 92.1% (129 of 140 patients) of the study patients. There were no differences in baseline characteristics, including sex and body surface area (1.64 ± 0.18 vs. 1.65 ± 0.15 m2) between the groups. The AVMPG on 1-year echocardiography was 14.0 ± 4.3 and 13.9 ± 5.1 mmHg in the AVALUS and CEPME groups, respectively (the p-value for noninferiority was 0.0004). In the subgroup analyses for the respective size of the prostheses, AVMPG of the 19-mm prostheses was significantly lower in the AVALUS group than in the CEPME group (14.0 ± 4.3 vs. 20.0 ± 4.7 mmHg, p = 0.012), whereas those of the other sizes were not significantly different between the two groups. There were no significant differences in the effective orifice area (1.49 ± 0.40 vs. 1.53 ± 0.38 cm2, p = 0.500) or effective orifice area index (0.91 ± 0.22 vs 0.93 ± 0.23 cm2/m2, p = 0.570) in all the patients, or in the subgroup analysis for the 19-mm prosthesis. There were no differences in the 1-year clinical outcomes between the two groups. The 1-year hemodynamic and clinical outcomes of the AVALUS group were noninferior to those of the CEPME group (NCT03796442).

Do postoperative hemodynamic parameters add prognostic value for mortality after surgical aortic valve replacement?

BackgroundAlthough various hemodynamic parameters to assess prosthetic performance are available, prosthesis–patient mismatch (PPM) is defined exclusively by effective orifice area (EOA) index thresholds. Adjusting for the Society of Thoracic Surgeons predicted risk of mortality (STS PROM), we aimed to explore the added value of postoperative hemodynamic parameters for the prediction of all-cause mortality at 5 years after aortic valve replacement. MethodsData were obtained from the Pericardial Surgical Aortic Valve Replacement (PERIGON) Pivotal Trial, a multicenter prospective cohort study examining the performance of the Avalus bioprosthesis. Candidate predictors were assessed at the first follow-up visit; patients who had no echocardiography data, withdrew consent, or died before this visit were excluded. Candidate predictors included peak jet velocity, mean pressure gradient, EOA, predicted and measured EOA index, Doppler velocity index, indexed internal prosthesis orifice area, and categories for PPM. The performance of Cox models was investigated using the c-statistic and net reclassification improvement (NRI), among other tools. ResultsA total of 1118 patients received the study valve, of whom 1022 were eligible for the present analysis. In univariable analysis, STS PROM was the sole significant predictor of all-cause mortality (hazard ratio, 1.40; 95% confidence interval, 1.26-1.55). When extending the STS PROM with single hemodynamic parameters, neither the c-statistics nor the NRIs demonstrated added prognostic value compared to a model with STS PROM alone. Similar findings were observed when multiple hemodynamic parameters were added. ConclusionsThe STS PROM was found to be the main predictor of patient prognosis. The additional prognostic value of postoperative hemodynamic parameters for the prediction of all-cause mortality was limited.

Influence of moderate prosthesis–patient mismatch on long-term outcomes in patients with severe aortic stenosis with paradoxically reduced gradients against the background of reduced stroke volume after aortic valve replacement with a biological prosthesis: retrospective comparative study

OBJECTIVE: Our aim was to evaluate the impact of moderate prosthesispatient mismatch on long-term results after aortic valve replacement in patients with severe aortic stenosis with paradoxically reduced gradients against the background of a reduced stroke volume of the left ventricle.&#x0D; MATERIALS AND METHODS: We analyzed data from 88 patients with symptomatic severe aortic stenosis meeting the criteria: paradoxically reduced gradients against the background of a reduced stroke volume of the left ventricle. Patients were divided into 2 groups: Group 1 (n=42, mean age 674 years) with paradoxically reduced gradients against the background of reduced stroke volume of the left ventricle, with a moderate patientprosthesis mismatch; Group 2 (n=46, mean age 686 years) with paradoxically reduced gradients against the background of reduced stroke volume of the left ventricle, without patientprosthesis discrepancy. All patients underwent transthoracic echocardiographic evaluation.&#x0D; RESULTS: The average follow-up period was 84 (quarterly interval 7598) months, during the follow-up period 35 (40%) deaths were registered. There were no significant differences in in-hospital mortality: 2 (4.7%) and 2 (4.3%), respectively (p=0.2). In the long-term follow-up period, there was a significant difference in survival and hospitalization rates for exacerbation of heart failure between patients with and without patientprosthesis mismatch: 46 and 71%, 37 and 72%, respectively (p0.001). In the long-term follow-up period, patients with patientprosthesis mismatch showed a trend towards slower regression of left ventricle mass and left atrial volume, as well as a slower recovery of global longitudinal deformation of the left ventricle and exercise tolerance compared with patients without patientprosthesis mismatch. There were no significant differences in the incidence of stroke (90% and 91%; p=0.7). According to the results of Cox regression, the left ventricular stroke volume index and the aortic valve effective orifice area index were independent predictors of lethal events and the risk of hospitalization for exacerbation of heart failure.&#x0D; CONCLUSION: Moderate patientprosthesis mismatch in patients with paradoxically reduced gradients associated with reduced left ventricular stroke volume is independently associated with increased mortality and increased hospitalization for exacerbations of heart failure.

Role of lipoprotein(a) concentrations in bioprosthetic aortic valve degeneration

ObjectivesLipoprotein(a) (Lp(a)) is associated with an increased incidence of native aortic stenosis, which shares similar pathological mechanisms with bioprosthetic aortic valve (bAV) degeneration. However, evidence regarding the role of Lp(a)...

Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Implantation in Patients With Small Aortic Annulus: A Meta-Analysis

Although transcatheter aortic valve implantation (TAVI) is considered a superior option to surgery in patients with small aortic annulus (SAA), it is not clear which type of transcatheter heart valve (THV) has better results in terms of echocardiographic hemodynamics and clinical outcomes. A random-effects meta-analysis was performed comparing balloon-expandable valves (BEVs) and self-expanding valves (SEVs) in patients with SAA who underwent TAVI regarding their impact on hemodynamic and clinical outcomes at short- and midterm follow-up. Relative risk (RR) and mean difference (MD) with 95% confidence interval (95% CI) were measured for the outcomes, as appropriate. Subgroup analyses were performed based on the generation type of devices and study designs. A total of 16 articles comprising 1 randomized trial, 3 propensity-matched studies, and 12 observational studies including 4,341 patients (1,967 in BEV and 2,374 in the SEV group) with SAA were included. The implantation of BEVs correlated with a lower indexed effective orifice area (MD -0.19 [-0.25 to -0.13]) and higher transvalvular mean pressure gradient (MD 3.91, 95% CI 2.96 to 4.87). Compared with SEVs, BEVs had increased risk of prosthesis-patient mismatch (PPM; RR 2.09, 95% CI 1.79 to 2.45) and severe PPM (RR 2.16, 95% CI 1.48 to 3.15). However, BEV had lower moderate and severe paravalvular leak (RR 0.45, 95% CI 0.29 to 0.69), risk of stroke (RR 0.57, 95% CI 0.42 to 0.76), and permanent pacemaker implantation (RR 0.63, 95% CI 0.44 to 0.91). The 1-year all-cause mortality (RR 1.13, 95% CI 0.86 to 1.49) and cardiac-related mortality (RR 1.53, 95% CI 0.24 to 9.81) were not different between the 2 groups. In conclusion, SEVs were associated with larger indexed effective orifice area and lower PPM but higher paravalvular leak. In contrast, patients with SEVs were more likely to develop stroke and required permanent pacemaker implantation. Both THVs did not show difference in terms of early and midterm all-cause and cardiac mortality. Because both types of THVs show similar results regarding mortality data, hemodynamics should be among the factors considered in decision making for patients with SAA who underwent TAVI.