Prosthesis-patient Mismatch Research Articles

Functional Mitral Regurgitation Post-Isolated Aortic Valve Replacement.

Background: The management of mitral regurgitation during aortic valve replacement remains a complex question. Secondary mitral regurgitation often improves post-aortic valve replacement without mitral valve surgery, but residual mitral regurgitation can significantly affect long-term outcomes. This study investigates the natural history of mitral regurgitation following isolated aortic valve replacement and identifies prognostic factors for persistent mitral regurgitation. Methods: A retrospective study was conducted on 108 patients who underwent isolated aortic valve replacement. Patients were categorized based on mitral regurgitation improvement. Additionally, patients were divided into patient-prosthesis mismatch and non-patient-prosthesis mismatch groups based on the aortic prosthesis. Preoperative and postoperative echocardiographic data were analyzed. Results: In total, 63% of patients showed mitral regurgitation improvement. The improved functional MR group showed significant reductions in peak and mean transvalvular pressure gradients. In contrast, the patient-prosthesis mismatch group had persistent mitral regurgitation improvement in 59.2% of patients. The non-patient-prosthesis mismatch group exhibited significant structural improvements and a reduction in mitral regurgitation severity in 68.6% of patients. Conclusions: The study shows that aortic valve replacement could significantly improve MR when patient-prosthesis mismatch is avoided. This approach maximizes hemodynamic outcomes, mitigates the risk of residual or worsening mitral regurgitation, and potentially reduces the need for additional mitral valve interventions.

Abstract 4132498: Hemodynamic and Clinical Outcomes with Balloon-Expandable Valves Versus Self-Expanding Valves in Patients with Small Aortic Annulus Undergoing Transcatheter Aortic Valve Implantation: A Meta-Analysis of Randomized Controlled Trials and Propensity Score Matched Studies

Background: Transcatheter aortic valve implantation (TAVI) is thought to be more effective than surgery for patients with small aortic annulus (SAA), however, the comparative efficacy of different transcatheter heart valves (THVs) remains uncertain. The objective of this meta-analysis was to compare the effects of balloon-expandable valves (BEVs) and self-expanding valves (SEVs) on hemodynamic parameters and clinical outcomes in patients with SAA who underwent TAVI. Methods: A thorough literature search was performed across PubMed/MEDLINE, Embase, and the Cochrane Library from their inception until May 2024 to identify eligible randomized controlled trials (RCTs) and propensity-score matched (PSM) studies. Clinical outcomes were evaluated using a random-effects model to pool risk ratios (RRs) with 95% confidence intervals (CIs). Results: The analysis included 8 studies; 2 RCTs and 6 PSM studies, with a total of 2,180 patients with SAA. BEVs were associated with a smaller indexed effective orifice area (MD: -0.18, 95% CI: -0.31 to -0.05) and a higher transvalvular mean pressure gradient (MD: 5.23, 95% CI 3.44 to 7.02) than SEVs. The risk for prosthesis-patient mismatch (PPM) (RR= 1.82, 95% CI: 1.27 to 2.60) and severe PPM (RR= 2.77, 95% CI: 1.93 to 3.98) was significantly higher for patients receiving BEVs than those receiving SEVs. However, no significant difference was observed between BEVs and SEVs regarding the risk of paravalvular leak (RR= 0.98, 95% CI: 0.57 to 1.69) and the permanent pacemaker implantation (RR= 0.78, 95% CI: 0.50 to 1.23). Although patients receiving BEVs showed a slightly lower risk of major bleeding events (RR= 0.69, 95% CI: 0.49 to 0.99), BEVs were associated with a significantly increased risk of 1-year cardiovascular mortality (RR= 1.61, 95% CI: 1.05 to 2.47) compared to those receiving SEVs. However, no significant differences were observed between BEVs and SEVs regarding 30-day all-cause mortality (RR= 1.19, 95% CI: 0.57 to 2.49), 1-year all-cause mortality (RR= 1.17, 95% CI: 0.89 to 1.53), stroke rates (RR= 0.83, 95% CI: 0.52 to 1.31) and any vascular complication (RR= 1.13, 95% CI: 0.72 to 1.75). Conclusion: In patients with SAA, SEVs showed reduced risks of PPM and severe PPM compared to BEVs, along with a larger indexed effective orifice area. Moreover, SEVs were associated with a lower risk of 1-year cardiovascular mortality.

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

Echocardiographic and clinical features of patients developing prosthesis-patient mismatch after TAVI: insights from an international multicenter registry

Abstract Background The impact of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) is controversial. Purpose Our study aims to evaluate the impact of PPM on mortality and clinical-echocardiographic progression of cardiac damage in a "real world" cohort of patients at intermediate and low surgical risk and to characterize its main predictors. Methods 963 patients who underwent TAVI procedure between 2017 and 2021, from an international multicenter observational registry, were included in this analysis. Multiparametric echocardiographic data were analyzed at 1-year follow-up (FU). Clinical and echocardiographic features were stratified by presence of PPM and PPM severity, as per the most current international recommendations (VARC-3 criteria). Results 18% of patients developed post-TAVI PPM, (7.7% of the whole cohort severe). At baseline, 50.3% of patients with PPM were male (vs 46.2% in the cohort without PPM, p=0.33), aged 82y (interquartile range (IQR) 79-85y) vs 82y (IQR 78-86y; p=0.46), and 55.6% had Balloon-Expandable valves implanted (vs 46.8% of patients without PPM, p=0.04); they had smaller left ventricular outflow tract (LVOT) diameter (20mm, IQR 19-21 vs 20mm, IQR 20-22, p=0.02), reduced Stroke Volume index (SVi) (34.2 vs 38 ml/m2, p<0.01) and transaortic flow rate (190.6 vs 211 ml/s, p<0.01). At pre-discharge FU patients with PPM had more paravalvular aortic regurgitation (AR) (moderate/severe AR 15.8% vs 9.2%, p<0.01). At a median FU of 1.46 years (IQR 1-4), there was no evidence of a significant impact of PPM on overall mortality (15.3% vs 13.1%, p=0.46) nor on rehospitalization rate for heart failure (4.3% vs 8.0%, p=0.10). At 1-year FU, maladaptive alterations of left ventricular parameters were found in patients with PPM, with a significant increase in endsystolic diameter (ESD) (33 vs 28mm, p=0.03) and a statistically non-significant increase in LV mass index (121 vs 106g/m2, p=0.07). Interestingly, trajectory parameters of patients with PPM from baseline to 1-year FU showed a reduced cardiac remodeling compared to patients without PPM, including no LVEF improvement (p=0.88), absent reduction of LV end-diastolic volume (p=0.70), indexed LV mass (p=0.31), ESD (p=0.48) and pulmonary artery systolic pressure (p=0.82), and an increase of basal RV diameter (p<0.001). Patients with moderate/severe PPM had worse NYHA functional class at 1 year (NYHA III-IV 13% vs 7.8%, p=0.03). Independent predictor of PPM at multivariable logistic regression was male gender (OR=1.93, p=0.04); while SVi (OR=0.86, p<0.001), prosthetic size >23mm (OR=0.62, p=0.03) and LVOT diameter (OR=0.79, p=0.02) had protective effect. Conclusions There was no evidence of a short- or medium-term impact of PPM on mortality. However, clinical-echocardiographic evaluations demonstrated a PPM-related pattern of early ventricular maladaptive alterations associated with a significant deterioration in NYHA class at 1 year.

Prosthesis-patient mismatch is associated with long-term mortality following surgical aortic valve replacement

Abstract Background Prosthesis-patient mismatch (PPM) refers to a situation where the indexed effective orifice area (iEOA) of an implanted prosthetic valve is too small relative to the patient's body size, resulting in hemodynamic compromise. Studies examining the long-term consequences of PPM after surgical aortic valve replacement (SAVR) have yielded conflicting results. Purpose To evaluate the impact of PPM on long-term outcomes in patients undergoing primary isolated SAVR. Methods All patients who underwent isolated first-time SAVR from 1990-2014 were included in this observational, single-center study. PPM was defined as a predicted iEOA <0.85 cm2/m2 and severe PPM was defined as an iEOA <0.65 cm2/m2. Patient demographics, surgical details, and in-hospital outcomes were prospectively collected in our institutional database. Cases were linked to provincial administrative databases at an independent, non-profit research institute whose legal status allows it to collect and analyze health care and demographic data. The primary outcome of interest was all-cause mortality. Secondary outcomes were aortic valve reoperation (surgical or transcatheter) and post-operative hospitalization for heart failure. Multivariable Cox regression analysis identified risk factors for long-term mortality. Kaplan-Meier curves were generated for long-term survival and cumulative incidence functions for aortic valve reoperation and heart failure hospitalization. Results A total of 1,798 patients were included (no PPM: 770 [43%]; moderate PPM: 943 [52%]; and severe PPM: 85 [5%]). Mean age was 64±13 years, and 750 (42%) were female. 451 (25%) patients received a mechanical valve, and 1347 (75%) received a stented bioprosthetic valve. Concomitant aortic root enlargement was performed in 492 (27%) patients. At 20 years, survival was 47.8% (95% CI: 43.2%–52.2%) in the "no PPM group" compared with 29.5% (95% CI: 25.6%–33.5%) and 24.7% (95% CI: 12.7%–38.8%) in the moderate and severe PPM groups, respectively (p<0.001) (Figure 1). On multivariable analysis, iEOA was independently associated with long-term mortality (HR 0.95 per 0.10 increase in iEOA, 95% CI [0.91–0.98]; p=0.007). In a pre-specified subgroup analysis, iEOA was found to be associated with late mortality in patients younger than 65 years (p<0.001) but not in patients 65 years and older (p=0.23). Readmission for heart failure was more frequent among patients who had PPM than those who did not (Figure 2). There was no difference in aortic valve reintervention in patients with or without PPM (p=0.654). Conclusions Prosthesis-patient mismatch is common after SAVR and is associated with late mortality and hospitalization for heart failure. The deleterious impact of PPM on survival appears more pronounced in young patients. These findings may have important implications for the lifetime management of patients with aortic valve disease.Survival post SAVRHeart failure hospitalization post SAVR

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

The impact of prosthesis-patient mismatch on clinical outcomes in patients undergoing transcatheter aortic valve implantation

Abstract Background There is considerable debate on the impact of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) on clinical outcomes. Objectives This study aimed to assess the impact of PPM after TAVI on clinical outcomes. Methods The current study population included 467 patients undergoing TAVI at our Hospital between 2014 and 2023. PPM was defined as moderate if ≥0.65 but <0.85 cm2/m2 (≥0.55 but <0.70 cm2/m2 if obese: body mass index>30 kg/m2) or severe if <0.65 cm2/m2 (<0.55 cm2/m2 if obese) at the indexed effective orifice area measured by transthoracic echocardiography at discharge. The primary outcome was a composite of all-cause death or heart failure hospitalization. Median follow-up duration was 2 years (Interquartile: 0.9 - 4.0 years). Results The median age of the current study population was 83.9 years. Moderate and severe PPM were seen in 78 (17%) and 11 (2%) patients, respectively. The factors associated with PPM included small valve size (SAPIEN 20 mm or CoreValve/Evolut 23 mm), balloon-expandable valves, and atrial fibrillation, but not post dilatation. There was no significant difference of the incidence of PPM between SAPIEN XT and SAPIEN 3 (21% and 21%, P= 0.98). PPM was not seen in SAPIEN 3 Ultra RESILIA (n= 0/10). The cumulative 3-year incidences of the primary outcome after TAVI were not significantly different between patients with and without PPM (22% and 27%, P= 0.42) (Figure 1 and 2). There was no significant difference of the primary outcome between patients with and without elevated (>20 mmHg) post-TAVI gradient (18% and 27%, P= 0.17). After adjusting confounders, the excess risk of PPM at discharge for the primary outcome was not significant (adjusted hazard ratio: 0.86, 95% confidence interval: 0.56-1.31, P= 0.48). Conclusions PPM was not associated with worse clinical outcomes in contemporary patients undergoing TAVI.Kaplan-Meier analysis and log-rank testcumulative incidence

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.

Transcatheter aortic valve replacement with balloon-expandable and self-expandable valves in Japanese patients with large annulus: the OCEAN-TAVI registry

Abstract Background East Asians have smaller aortic valve complexes than individuals from Western countries, and few studies have reported transcatheter aortic valve replacement (TAVR) outcomes in Asian patients with a large annulus. Purpose We aimed to compare the acute and long-term outcomes of TAVR using balloon-expandable valves (BEVs) and self-expandable valves (SEVs) in Asian patients with a large annulus. Methods We retrospectively analyzed the data from the Optimized transCathEter vAlvular interveNtion Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry. A large annulus was defined by annular area ≥ 500 mm2 and average diameter ≥ 25 mm in computed tomography scans. The primary endpoint was the 3-year all-cause mortality. Secondary endpoints were 3-year heart-failure rehospitalization (HFR) after TAVR, acute outcomes of TAVR, and changes in valve function on echocardiography 2 years after TAVR. Results Among 773 patients, 671 (86.8%) underwent BEV-TAVR. The SEV-TAVR group showed a significantly higher incidence of above-moderate perivalvular leakage (2.1% vs. 7.8%; P < 0.001), and included a significantly greater percentage of patients who required postoperative pacemaker implantation (6.1% vs. 11.8%; P = 0.035). The incidence of moderate-to-severe prosthesis–patient mismatch did not differ between the two groups. The Kaplan–Meier curve showed no significant intergroup differences in the 3-year all-cause mortality and HFR rates (log-rank P = 0.900), and the echocardiography-indexed effective orifice area and mean transaortic valve pressure gradient at 2 years post-TAVR did not differ significantly between the two groups. Conclusions The benefits of BEV-TAVR may outweigh those of SEV-TAVR in patients with a large annulus.

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.

Three-Year Outcomes Following TAVR in Younger (

Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery. The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years. In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery (P=0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; P=0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; P<0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, P=0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients (P<0.001) and lower rates of severe prosthesis-patient mismatch (P<0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation. Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR. URL: https://clinicaltrials.gov; Unique identifier: NCT02701283.

Transcatheter Aortic Valve Implantation by Valve Type in Women With Small Annuli

Historically, women with aortic stenosis have experienced worse outcomes and inadequate recognition compared to men, being both underdiagnosed and undertreated, while also facing underrepresentation in clinical trials. To determine whether women with small aortic annuli undergoing transcatheter aortic valve replacement have better clinical and hemodynamic outcomes with a self-expanding valve (SEV) or balloon-expandable valve (BEV). The Small Annuli Randomized to Evolut or SAPIEN Trial (SMART) was a large-scale randomized clinical trial focusing on patients with small aortic annuli undergoing transcatheter aortic valve replacement, randomized to receive SEVs or BEVs and included 716 patients treated at 83 centers in Canada, Europe, Israel, and the US from April 2021 to October 2022. This prespecified secondary analysis reports clinical and hemodynamic findings for all 621 women enrolled in SMART. Data for this report were analyzed from February to April 2024. Transcatheter aortic valve replacement with an SEV or a BEV. The composite coprimary clinical end point comprised death, disabling stroke, or heart failure-related rehospitalization. The coprimary valve function end point was the incidence of bioprosthetic valve dysfunction, both assessed through 12 months. Secondary end points included the incidence of moderate or severe prosthesis-patient mismatch. A total of 621 women (mean [SD] age, 80.2 [6.2] years; 312 randomized to the SEV group and 309 to the BEV group) were included in the present analysis. At 12 months, there were no significant differences in the coprimary clinical end point between the SEV and BEV groups (9.4% vs 11.8%, absolute risk difference -2.3%; 95% CI -7.2 to 2.5, P = .35). However, SEV implantation was associated with less bioprosthetic valve dysfunction (8.4% vs 41.8%; absolute risk difference, -33.4%; 95% CI, -40.4 to -26.4; P < .001). SEV implantation resulted in lower aortic valve gradients and larger effective orifice areas at 30 days and 12 months and less mild or greater aortic regurgitation at 12 months compared to BEV implantation. Prosthesis-patient mismatch was significantly lower with SEVs, regardless of the definition used and adjustment for body mass index. Use of SEVs was associated with better quality of life outcomes as assessed by the Valve Academic Research Consortium-3 ordinal quality of life measure. Among women with severe symptomatic aortic stenosis and small aortic annuli undergoing transcatheter aortic valve replacement, the use of SEVs, compared to BEVs, resulted in similar clinical outcomes and a markedly reduced incidence of bioprosthetic valve dysfunction through 12 months, including a lower risk of prosthesis-patient mismatch and better 12-month quality of life. ClinicalTrials.gov Identifier: NCT04722250.

Update on Prosthesis–Patient Mismatch Following Transcatheter Aortic Valve Replacement in Asian Patients

BackgroundProsthesis–patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) is of greater concern in Asians, considering their relatively smaller annular sizes compared with Westerners. However, the prognostic significance of PPM in Asian populations has not been demonstrated. ObjectivesThis study aimed to elucidate the prognostic value of PPM after TAVR in Asian patients. MethodsPatients undergoing TAVR from October 2013 to December 2019 were enrolled from the OCEAN-TAVI (Optimized CathEter vAlvular iNtervention—Transcatheter Aortic Valve Implantation) registry. PPM was classified based on the indexed effective orifice area as severe (≤0.65 cm2/m2) or moderate (0.66-0.85 cm2/m2) in the general population, and severe (≤0.55 cm2/m2) or moderate (0.56-0.70 cm2/m2) in the obese population (body mass index of ≥30 kg/m2). ResultsOf the 7,072 eligible patients, moderate and severe PPM were identified in 742 (10.5%) and 94 (1.3%) patients, respectively. Severe PPM relative to non-PPM was independently associated with higher adjusted risks for 3-year all-cause mortality (adjusted HR: 1.79; 95% CI: 1.16-2.78; P = 0.009) and heart failure hospitalization (adjusted HR: 1.88; 95% CI: 1.07-3.28; P = 0.027), whereas no significant difference in these outcomes was observed between moderate PPM and no PPM. ConclusionsSevere PPM following TAVR was observed in only 1.3% of our Japanese cohort, but was associated with an increased risk of mortality and heart failure hospitalization at 3 years. These results warrant the implementation of preventive strategies to obviate severe PPM after TAVR, also in Asian patients.

Left Ventricular Hypertrophy Regression Following Transcatheter Aortic Replacement: A Comparison of Self-Expanding Versus Balloon-Expandable Prostheses

There are limited reports on the impact of prosthesis-patient mismatch (PPM) on the regression of left ventricular hypertrophy (LVH) after transcatheter aortic valve replacement (TAVR). We compared the relative effects of supra-annular, self-expanding (SE) versus intra-annular, balloon-expandable (BE) prostheses on TAVR LVH regression. Regression of left ventricular mass index (LVMi) was evaluated in 168 consecutive TAVR patients, including 60 treated with SE valves (Evolut series) and 108 treated with BE valves (Sapien 3). All patients had LVH determined at baseline by echocardiography and had repeat LVMi measurements at a mean follow-up time of 707 ± 528 days. SE patients were more likely female (68.3% vs 46.3%, p = 0.007), but otherwise, the 2 cohorts did not differ with respect to baseline demographics and Society of Thoracic Surgeons risk score. SE patients had a higher effective orifice area indexed to body surface area after TAVR (0.98 ± 0.29 vs 0.86 ± 0.25 cm²/m², p = 0.006), with lower mean aortic valve gradients (9.9 ± 6.5 vs 12.8 ± 5.8 mm Hg, p = 0.003) and a lower prevalence of moderate/severe PPM (33.3% vs 49.1%, p = 0.049). On follow-up, changes in LVMi were similar between the SE and BE groups, with similar absolute changes in LVMi (19.2 ± 26.8 vs 21.9 ± 31.7 g/m2, p = 0.578) and relative LVMi decrease (14.0 ± 19.5 vs 16.2% ± 24.2%, p = 0.547). No difference in LVMi regression was also noted comparing combined SE/BE patients with moderate/severe PPM versus those without PPM. In conclusion, despite differences in effective orifice area indexed to body surface area, mean aortic valve gradient, and PPM after TAVR, the degree of LVH regression during intermediate follow-up did not differ between patients receiving supra-annular SE and intra-annular BE prostheses.

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 .

Supra-Annular Self-Expanding Versus Balloon-Expandable Valves for Valve-in-Valve Transcatheter Aortic Valve Replacement

Self-expanding (SE) and balloon-expandable (BE) transcatheter heart valves (THVs) have not been extensively studied in valve-in-valve transcatheter aortic valve replacement (ViV-TAVR). We compared outcomes of supra-annular SE and BE THVs used for ViV-TAVR via a retrospective analysis of institutional data (2013-2023) including all patients undergoing ViV-TAVR (TAVR in previous surgical AVR). Unmatched and propensity-matched (1:1) comparisons of clinical and echocardiographic outcomes were undertaken between SE and BE THV along with Kaplan-Meier survival analysis. A total of 315 patients undergoing ViV-TAVR were included of which 73% received a SE THV. Median age was 77 years and women comprised 42.5% of the population. Propensity-score matching (1:1) yielded 81 matched pairs. Implanted aortic valve size was comparable between the groups (23 mm [23-26] vs. 23mm [23-26], p=0.457). At 30 days following ViV-TAVR, the SE group had a lower mean aortic valve gradient (14 mmHg [11-18] vs. 17.5 mmHg [13-25], p=0.007). A higher number of BE patients had severe prosthesis-patient mismatch (PPM) (16% vs. 6.2%, p=0.04). At one-year follow-up, the SE group had a lower aortic valve gradient (14.0 mmHg [9.6-19] vs. 17 mmHg [13-25], p=0.04) compared to the BE group. 30-day mortality was 2.7% while one-year mortality was 7.5% and comparable between the groups. Survival and stroke incidence were similar in both groups up to 5 years. In conclusion, both SE and BE THVs had comparable survival following ViV-TAVR. The higher residual aortic valve gradients in BE THVs are likely due to valve design and warrant long-term evaluation for potential structural valve degeneration.

Balloon-Expandable vs Self-Expanding Valves for Transcatheter Treatment of Sievers Type 1 Bicuspid Aortic Stenosis.

Balloon-expandable valves (BEVs) and self-expanding valves (SEVs) have different features that may impact the outcomes of patients with Sievers type 1 bicuspid aortic valve (BAV) stenosis undergoing transcatheter aortic valve replacement. This study sought to compare procedural and clinical outcomes of BEVs and SEVs in Sievers type 1 BAV stenosis. AD-HOC (Characteristics, Sizing, and Outcomes of Stenotic Raphe-Type Bicuspid Aortic Valves Treated With Transcatheter Device Implantation) is an observational registry enrolling patients with Sievers type 1 BAV stenosis undergoing transcatheter aortic valve replacement with current-generation BEVs and SEVs at 24 international centers. A 1:1 propensity score matching analysis was performed to adjust for baseline imbalances. The primary endpoint was midterm major adverse events, defined as a composite of all-cause death, neurologic events, or hospitalization for heart failure. Among 955 eligible patients, propensity score matching resulted in 301 pairs. At a median follow-up of 1.3years, BEVs and SEVs had a similar risk of major adverse events (BEV vs SEV: HR: 0.75; 95%CI: 0.49-1.16; P = 0.200). Technical success was similar (OR: 1.38; 95%CI: 0.63-3.04; P = 0.421). At 30days, BEVs were associated with a lower risk of new permanent pacemaker implantation (OR: 0.42; 95%CI: 0.24-0.72; P = 0.002) and moderate or greater paravalvular regurgitation (OR: 0.16; 95%CI: 0.05-0.48; P = 0.001) but a higher risk of severe patient-prosthesis mismatch (OR: 3.03; 95%CI 1.02-8.95; P = 0.045). Current-generation BEVs and SEVs proved similar technical success and midterm clinical efficacy in Sievers type 1 BAV stenosis. Compared to SEVs, BEVs were associated with less permanent pacemaker implantation and moderate or greater paravalvular regurgitation but with more severe patient-prosthesis mismatch.

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.

Routine postdilation after 23 mm Sapien 3 Ultra implantation in the aortic position.

Residual transprosthetic gradient (TG) after transcatheter aortic valve replacement (TAVR) with balloon-expandable valves (BEV) may be due to suboptimal valve expansion. To compare hemodynamics after TAVR with small BEV according to postdilation strategy. This observational, retrospective cohort study included 184 consecutive patients from a single center treated with 23 mm Sapien 3 Ultra (Edwards Lifesciences) BEV implantation in the aortic position and enrolled between January 2020 and April 2023. Patients treated with routine postdilation (RP, n = 73) were compared to patients treated according to local standard practice (SP, n = 111). Primary endpoint was 30-day mean TG. Secondary endpoints were incidence of 30-day prosthesis-patient mismatch (PPM), technical success and device success. Thirty-day mean TG was lower in RP versus SP (12.3 ± 4.6 mmHg vs. 14.1 ± 5.7 mmHg, p = 0.031), and incidence of PPM was less common with RP versus SP (47.3% vs. 71.0%, p = 0.006). Technical success (98.6% vs. 99.1%, p = 0.637) and device success (93.1% vs. 90.1%, p = 0.330) did not differ between groups. Differences in 30-day mean TG were driven by patients at normal flow (12.1 ± 4.0 mmHg vs. 15.0 ± 5.5 mmHg, p = 0.014), while no differences were evident among patients at low flow (12.5 ± 5.5 mmHg vs. 11.7 ± 5.5 mmHg, p = 0.644). RP decreased height and increased width of BEV, and a linear regression established that final BEV width could predict 30-day mean TG (r = -0.6654, p < 0.0001). RP after TAVR with small BEV was associated with more favorable forward-flow hemodynamics than SP.

Trends and Outcomes of Aortic Root Enlargement During Bioprosthetic Aortic Valve Replacement

BackgroundAortic root enlargement (ARE) during aortic valve replacement (AVR) mitigates prosthesis-patient mismatch, but its use has been low. Transcatheter aortic valve-in-valve (VIV) as a treatment for failing bioprosthetic valves is limited by small surgical valves, renewing interest in ARE during the index AVR. This study demonstrates trends and outcomes of ARE after commercial approval of VIV in 2015. MethodsThis retrospective cohort study analyzed 2182 patients undergoing nonemergent AVR between August 2007 and December 2022. Endocarditis, aortic dissection, and concomitant root replacement or ventricular assist device placement were excluded. Trends in ARE use, valve size, and types were compared. Outcome measures included 30-day mortality and gradients and were compared between patients with and without ARE. ResultsOverall, 74 patients (3.4%) underwent ARE, 14 (1.0%) before 2015 and 60 (7.6%, P < .0001) after 2015. Use of smaller valves (19-21 mm) decreased from 372 (26.8%) before 2015 to 85 (10.7%, P < .0001) after 2015. ARE group was younger than the AVR-alone group (64 vs 68 years, P = .001) but had similar predicted risk of mortality (median, 1.7%). Both groups had comparable postoperative mean gradients (ARE: 11 vs AVR-alone: 10 mm Hg, P = .42). ARE had higher 30-day mortality (5 [7%] vs 48 [2%], P = .014); however, no difference was found in elective patients (2 of 65 [3%] vs 39 of 1898 [2%], P = .57). ConclusionsARE use has increased since commercial approval of VIV. The addition of ARE to AVR did not affect early safety in elective cases, and postoperative gradients were similar to those in patients not requiring ARE. Further studies are required to determine long-term outcomes after ARE, including VIV candidacy.