Moderate Prosthesis-patient Mismatch Research Articles

Incidence and Prognosis of Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement for Bicuspid Aortic Stenosis.

Evidence regarding the incidence of prosthesis-patient mismatch (PPM) and long-term mortality after transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS) is scarce. This study sought to assess the incidence and prognostic impact of PPM after TAVR for bicuspid AS compared with that for tricuspid AS. In total, 7,393 patients who underwent TAVR were prospectively enrolled in the OCEAN-TAVI (Optimized Catheter Valvular Intervention Transcatheter Aortic Valve Implantation) registry, an ongoing Japanese, multicenter registry. We analyzed 7,051 patients (median age=85 years, 68.4% women) and identified 503 (7.1%) with bicuspid AS. We compared the incidence of PPM and long-term mortality in 497 patients with and 497 without bicuspid AS after one-to-one propensity score matching analysis. Among the 7,051 patients, moderate and severe PPM were observed in 756 (10.7%) and 92 (1.3%) patients, respectively. Upon Kaplan-Meier curve analysis of the overall cohort, severe PPM appeared to be associated with long-term mortality (log-rank test, P=0.065). After propensity score matching analysis, moderate and severe PPM were more frequently observed among patients with tricuspid AS than patients with bicuspid AS (moderate PPM, 11.7% vs 4.4%; severe PPM, 1.4% vs 1.0%; P=0.0001). Severe PPM appeared to be associated with all-cause mortality. Moderate and severe PPM were more frequently observed in patients with tricuspid AS than patients with bicuspid AS.

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

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

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

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.

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

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.

Efficacy and safety of TAVR versus SAVR in patients with small aortic annuli: A systematic review and meta-analysis

IntroductionPatients with a small aortic annulus (SAA) undergoing aortic valve replacement are at increased risk of patient-prosthesis mismatch (PPM), which adversely affects outcomes. Transcatheter aortic valve replacement (TAVR) has shown promise in mitigating PPM compared to surgical aortic valve replacement (SAVR). MethodsWe conducted a systematic review and meta-analysis following PRISMA guidelines to compare clinical outcomes, mortality, and PPM between SAA patients undergoing TAVR and SAVR. Eligible studies were identified through comprehensive literature searches and assessed for quality and relevance. ResultsNine studies with a total of 2476 patients were included. There was no significant difference in 30-day Mortality between TAVR vs SAVR groups (OR = 0.65, 95% CI [ 0.09–4.61], P = 0.22). There was no difference between both groups regarding myocardial infarction at 30 days (OR = 0.63, 95% CI [0.1–3.89], P = 0.62). TAVR was associated with a significantly lower 30-day major bleeding and 2-year major bleeding, Pooled studies were homogeneous (OR = 0.44, 95% CI [0.31–0.64], P < 0.01, I2 = 0, P = 0.89), (OR = 0.4 ,95% CI [0.21–0.77], P = 0.03, I2 = 0%, P = 0.62) respectively. TAVR was associated with a lower rate of moderate PPM (OR = 0.6, 95% CI [ 0.44–0.84], p value = 0.01, i2 = 0%, p value = 0.44). The overall effect estimate did not favor any of the two groups regarding short-term Mild AR (OR = 5.44, 95% CI [1.02–28.91], P = 0.05) and Moderate/severe AR (OR = 4.08, 95% CI [ 0.79–21.02], P = 0.08, I2 = 0%, P = 0.59). ConclusionOur findings suggest that both TAVR and SAVR are viable options for treating AS in patients with a small aortic annulus. TAVR offers advantages in reducing PPM and major bleeding, while SAVR performs better in terms of pacemaker implantation. Future studies should focus on comparing newer generation TAVR techniques and devices with SAVR. Consideration of patient characteristics is crucial in selecting the optimal treatment approach for AS.

Echocardiographic and clinical features of patients developing prosthesis‐patient mismatch after transcatheter aortic valve replacement: Insights from the Recovery-TAVR registry

The impact of prosthesis-patient mismatch (PPM) on major endpoints after transcatheter aortic valve replacement (TAVR) is controversial and the effects on progression of heart damage are poorly investigated. Therefore, our study aims to evaluate the prevalence and predictors of PPM in a "real world" cohort of patients at intermediate and low surgical risk, its impact on mortality and the clinical-echocardiographic progression of heart damage. 963 patients who underwent TAVR procedure between 2017 and 2021, from the RECOVERY-TAVR international multicenter observational registry, were included in this analysis. Multiparametric echocardiographic data of these patients 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, using VARC-3 criteria. 18% of patients developed post-TAVR. PPM, and 7.7% of the whole cohort had severe PPM. At baseline, 50.3% of patients with PPM were male (vs 46.2% in the cohort without PPM, P = .33), aged 82 (IQR 79-85y) years vs 82 (IQR 78-86 P = .46), and 55.6% had Balloon-Expandable valves implanted (vs 46.8% of patients without PPM, P = .04); they had smaller left ventricular outflow tract (LVOT) diameter (20 mm, IQR 19-21 vs 20 mm, IQR 20-22, P = .02), reduced SVi (34.2 vs 38 mL/m2, P < .01) and transaortic flow rate (190.6 vs 211 mL/s, P < .01). At predischarge FU patients with PPM had more paravalvular aortic regurgitation (moderate-severe AR 15.8% vs 9.2%, P < .01). At 1-year FU, maladaptive alterations of left ventricular parameters were found in patients with PPM, with a significant increase in end-systolic diameter (33 mm vs 28 mm, P = .03) and a significant increase in left ventricle end systolic indexed volume in those with moderate and severe PPM (52 IQR 42-64 and 52, IQR 41-64 vs 44 IQR 35-59 in those without, P = .02)). No evidence of a significant impact of PPM on overall (P = .71) and CV (P = .70) mortality was observed. Patients with moderate/severe PPM had worse NYHA functional class at 1 year (NYHA III-IV 13% vs 7.8%, P = .03). Prosthesis size≤23 mm (OR 11.6, 1.68-80.1) was an independent predictor of PPM, while SVi (OR 0.87, 0.83-0.91, P < .001) and LVOT diameter (OR 0.79, 0.65-0.95, P = .01) had protective effect. PPM was observed in 18% of patients undergoing TAVR. Echocardiographic evaluations demonstrated a PPM-related pattern of early ventricular maladaptive alterations, possibly precursor to a reduction in cardiac function, associated with a significant deterioration in NYHA class at 1 year. These findings emphasize the importance of prevention of PPM of any grade in patients undergoing TAVR procedure, especially in populations at risk.

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.

Long term impact of measured and predicted prosthesis patient mismatch following transcatheter aortic valve replacement

Abstract Objectives To investigate the long-term clinical impact of prosthesis-patient mismatch (PPM) in patients undergoing transcatheter aortic valve implantation(TAVI). Background Both measured and predicted effective orifice area indexed to the body surface area (EOAi) have been suggested to define PPM in patients undergoing TAVI. The impact of PPM on clinical outcomes may accumulate with extended follow-up and vary according to the definition used. Methods Patients included in a prospective TAVI registry were stratified by the presence of moderate (0.65-0.85 cm2/m2 or 0.55-0.70 cm2/m2 if obese) or severe (≤0.65 cm2/m2 or ≤0.55 cm2/m2 if obese) PPM according to echocardiographically measured EOAi (measured PPM) prior to discharge, predicted EOAi based on published EOA reference values for each valve model and size (predicted PPMTHV), or predicted EOAi based on EOA reference derived from computed tomography measurements of aortic annulus dimension (predicted PPMCT). Results In an analysis of 2,463 patients, the incidence of measured PPM (moderate: 27.0%; severe: 8.7%) was higher than the incidence of predicted PPMTHV (moderate: 11.3%; severe: 1.2%) or predicted PPMCT (moderate: 12.0%; severe: 0.1%). During a median time to death of 843 days, mortality rates at 10 years were comparable in patients with versus without measured PPM or predicted PPMCT. In contrast, patients with moderate predicted PPMTHV had a lower risk of 10-year all-cause mortality compared with those without PPM (HR: 0.69; 95% CI: 0.52-0.90). Conclusions The use of predicted as compared to measured EOAi results in a lower estimate of PPM severity in TAVI ptients. We observed no increased risk of death in patients with PPM throughout 10-year of follow-up.Incidence of PPM after TAVIImpact of Measured an Predicted PPM

Abstract 17651: Long-Term Outcomes of Prosthesis-Patient Mismatch After Surgical Aortic Valve Replacement: Meta-Analysis of Kaplan-Meier-Derived Individual Patient Data

Introduction - It remains controversial whether prosthesis-patient mismatch (PPM) impacts long-term outcomes after surgical aortic valve replacement (SAVR). Hypothesis - PPM is associated with poor outcomes after SAVR. Methods - Study-level meta-analysis of reconstructed time-to-event data from Kaplan-Meier curves of studies published by March 2023. Results - Sixty-five studies met our eligibility criteria and included 122,989 patients (any PPM: 68,332 patients, 55.6%). At 25 years of follow-up, the survival rates were 11.8% and 20.6% in patients with and without any PPM, respectively (HR 1.16; 95%CI 1.13-1.18, p&lt;0.001). At 20 years of follow-up, the survival rates were 19.5%, 12.1 and 8.8% in patients with no, moderate and severe, respectively (moderate vs no PPM: HR 1.09; 95%CI 1.06-1.11; p&lt;0.001; severe vs no PPM: HR 1.29; 95%CI 1.24-1.35; p&lt;0.001). RMST was 0.8 years shorter in patients with moderate PPM, and 2.1 years shorter in patients with severe PPM in comparison with patients without PPM (10.2 years and 8.9 years vs. 11.0 years respectively, p&lt;0.001). PPM was associated with higher risk of cardiac death, HF-related hospitalizations and aortic valves reinterventions over time (p&lt;0.001). Statistically significant associations between PPM and worse survival were observed regardless of type of valves (bioprosthetic vs mechanical valves), contemporary PPM definitions unadjusted and adjusted to body mass index and PPM quantification method (in vitro, in vivo, Doppler echocardiography). Our meta-regression analysis revealed that populations with more women tend to have higher HRs for all-cause death associated with PPM. Conclusions - The results of the present study suggest that any degree of PPM is associated with poorer long-term outcomes following SAVR and provide support for implementation of preventive strategies to avoid PPM after SAVR.

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.

Long-term outcomes of measured and predicted prosthesis-patient mismatch following transcatheter aortic valve replacement.

Both measured and predicted effective orifice area (EOA) indexed to the body surface area (EOAi) have been suggested to define prosthesis-patient mismatch (PPM) in patients undergoing transcatheter aortic valve replacement (TAVR). The impact of PPM on clinical outcomes may accumulate with extended follow-up and vary according to the definition used. We aimed to investigate the long-term clinical impact of PPM in patients undergoing TAVR. Patients in a prospective TAVR registry were stratified by the presence of moderate (0.65-0.85 or 0.55-0.70 cm2/m2 if obese) or severe (≤0.65 or ≤0.55 cm2/m2 if obese) PPM according to echocardiographically measured EOAi (measured PPM), predicted EOAi based on published EOA reference values for each valve model and size (predicted PPMTHV), or predicted EOAi based on EOA reference values derived from computed tomography measurements of aortic annulus dimensions (predicted PPMCT). In an analysis of 2,463 patients, the frequency of measured PPM (moderate: 27.0%; severe: 8.7%) was higher than the frequency of predicted PPMTHV (moderate: 11.3%; severe: 1.2%) or predicted PPMCT (moderate: 12.0%; severe: 0.1%). During a median follow-up of 429 days, 10-year mortality was comparable in patients with versus without measured PPM or predicted PPMCT. In contrast, patients with moderate predicted PPMTHV had a lower risk of 10-year all-cause mortality compared with those without PPM (adjusted hazard ratio: 0.73, 95% confidence interval: 0.55-0.96). The use of predicted versus measured EOAi results in a lower estimate of PPM severity. We observed no increased risk of death in patients with PPM over a median follow-up time of 429 days. gov: NCT01368250.

Impact of Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement

BackgroundData on the long-term impact of prosthesis-patient mismatch (PPM) on outcomes after transcatheter aortic valve replacement (TAVR) remain sparse. We therefore aimed to investigate the incidence, predictive factors, and long-term prognostic impact of PPM on bioprosthesis durability and mortality. MethodsThis was a single-centre retrospective study including 2117 patients who underwent TAVR for aortic stenosis from 2002 to 2022. Moderate PPM was defined by indexed effective orifice area (iEOA) > 0.65 and ≤ 0.85 cm2/m2 (> 0.55 and ≤ 0.70 cm2/m2 if BMI ≥ 30 kg/m2) and severe PPM by an iEOA ≤ 0.65 cm2/m2 (≤ 0.55 cm2/m2 If BMI ≥ 30 kg/m2). ResultsThere were 351 patients (16.6%) with PPM, including 39 patients (1.8%) with severe PPM and 312 patients (14.7%) with moderate PPM. The mean follow-up duration was 31.2 ± 26.5 months. Factors independently associated with the occurrence of PPM were body surface area (odds ratio [OR] 3.32, 95% confidence interval [CI] 1.32-8.35; P = 0.01), valve-in-valve TAVR (OR 6.12, 95% CI 2.29-16.08; P < 0.001), small annulus (OR 2.42, 95% CI 1.41-4.07; P = 0.001), and the use of a balloon-expandable valve (OR 4.17, 95% CI 2.17-8.33; P < 0.001). PPM was associated with increased risk of mortality (hazard ratio [HR] 1.3, 95% CI 1.1-1.5, P = 0.004) and valve thrombosis (HR 4.2, 95% CI 1.4-12.6, P = 0.01), and a trend towards increased risk of structural valve deterioration (HR 1.7, 95% CI 0.9-2.9; P = 0.08). ConclusionsThe results of this study suggest that PPM has a negative long-term impact on outcomes after TAVR. These findings emphasise the importance of preventing PPM.

Prosthesis-patient mismatch after transcatheter implantation of contemporary balloon-expandable and self-expandable valves in small aortic annuli.

Evidence of clinical impact of PPM after TAVI is conflicting and might vary according to the type of valve implanted. To assess the clinical impact of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) with balloon-expandable (BEV) and self-expandable valves (SEV) in patients with small annuli. TAVI-SMALL 2 enrolled 628 patients in an international retrospective registry, which included patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 ) treated with transfemoral TAVI at 16 high-volume centers between 2011 and 2020. Analyses were performed comparing patients with less than moderate (n = 452), moderate (n = 138), and severe PPM (n = 38). Primary endpoint was incidence of all-cause mortality. Predictors of all-cause mortality and PPM were investigated. At a median follow-up of 380 days (interquartile range: 210-709 days), patients with severe PPM, but not moderate PPM, had an increased risk of all-cause mortality when compared with less than moderate PPM (log-rank p = 0.046). Severe PPM predicted all-cause mortality in patients with BEV (hazard ratio [HR]: 5.20, 95% confidence interval [CI]: 1.27-21.2) and intra-annular valves (IAVs, HR: 4.23, 95% CI: 1.28-14.02), and it did so with borderline significance in the overall population (HR: 2.89, 95% CI: 0.95-8.79). Supra-annular valve (SAV) implantation was the only predictor of severe PPM (odds ratio: 0.33, 95% CI: 0.13-0.83). Patients with small aortic annuli and severe PPM after TAVI have an increased risk of all-cause mortality at early term follow-up, especially after IAV or BEV implantation. TAVI with SAV protected from severe PPM.

Self-expanding vs. balloon-expandable transcatheter heart valves in small aortic annuli.

Clinical consequences of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) is currently in the focus of clinical research. Patients with small aortic annulus are at higher risk to display PPM. Data on incidence and clinical consequences of PPM after TAVR with either balloon-expandable (BEV) or self-expanding (SEV) transcatheter heart valves in small aortic annulus are sparse. Patients with small aortic annulus (perimeter < 72 mm or aortic annulus area < 400 mm2) who underwent BEV or SEV with contemporary transcatheter heart valve types were identified from the institutional TAVR database. Propensity score matching was applied for imbalanced baseline characteristics between patients undergoing BEV or SEV. Echocardiography and clinical follow-up beyond 3 years was reported following VARC-3 recommendations. Primary endpoint was the incidence of pre-discharge PPM and its association with 3-year mortality. From a total of 507 patients with small aortic annulus, 192 matched patient pairs with SEV or BEV were identified. Mean age was 81 ± 7 (SEV) vs. 81 ± 6 (BEV) years (p = 0.5), aortic annulus perimeter was 69 ± 3 vs.69 ± 3 mm, (p = 0.8), annulus area was 357 ± 27 vs.357 ± 27 mm2 (p = 0.8), and EuroScore II was 5.8 ± 6.6 vs.5.7 ± 7.2 (p = 0.9). SEV resulted in less moderate (20% vs. 31%, p < 0.001) and severe pre-discharge PPM (9% vs.18%, p < 0.001) compared to BEV. At discharge (7 ± 4 vs. 12 ± 9 mmHg, p = 0.003) and at 1-year follow-up (7 ± 5 vs.13 ± 3 mmHg, p < 0.001), SEV displayed lower mean gradients compared to BEV. Estimated survival after SEV was 85% (95% confidence interval (CI): 80%-90%) at 1 year, 80% (95% CI: 75%-86%) at 2 years, and 71% (95% CI: 65%-78%) at 3 years; estimated survival after BEV was 87% (95% CI: 82%-92%) at 1 year, 81% (95% CI: 75%-86%) at 2 years, and 72% (95% CI: 66%-79%) at 3 years, with no significant difference among the groups (p = 0.9) Body surface area (OR: 1.35, p < 0.001), implantation of BEV (odds ratio (OR): 3.32, p < 0.001), and the absence of postdilatation (OR: 2.16, p < 0.001) were independent risk factors for any PPM. At 3 years, patients without PPM had a higher 3-year survival compared with patients with ≥moderate PPM (77% vs. 67%, p = 0.03). BEV implantation in patients with small annulus was associated with a twofold higher incidence of pre-discharge severe PPM compared to SEV implantation. Survival at 3 years after TAVR was similar after BEV and SEV. However, patients with the absence of pre-discharge PPM had a higher 3-year survival compared to patients with ≥moderate PPM.

Correlation between measured and predicted mismatch with valve hemodynamics in transcatheter aortic valve replacement: A sex-based analysis.

Data regarding the reliability of predicted effective orifice area indexed (pEOAi) is scarce in transcatheter aortic valve replacement (TAVR). To assess the validity of the pEOAi in TAVR by correlating its value with echocardiography-derived hemodynamic data. A single-center retrospective cohort study of TAVR patients from 2012 to 2021 with available echocardiograms was conducted. Patient-prosthesis mismatch (PPM) was defined based on the Valve Academic Research Consortium 3 criteria. The main endpoints were the congruence of measured effective orifice area indexed(EOAi) and pEOAi with the hemodynamic data obtained by echocardiography. The secondary endpoint included a correlation of predicted PPM (pPPM) and measured PPM (mPPM) with postoperative New York Heart Association(NYHA) status. A total of 318 patients were included. pPPM was more frequent than mPPM (54 [17%]; all moderate PPM vs. 39 [12.3%]: 32 moderate and 7 severe PPM).Predicted and measured EOAi were statistically correlated with postprocedural transvalvular mean gradient and Doppler velocity index (all p < 0.001), including in both sex-based subgroups. The positive predictive value and negative predictive value (NPV) of pPPM for postprocedural transvalvular mean gradient ≥ 20 mmHg were 16% and 97%, respectively. Only pPPM was significantly more prevalent in the group in which NYHA failed to improve than in those with symptom improvement (30.1% vs. 16%, p = 0.027). Predicted PPM has an excellent NPV for postprocedural transvalvular mean gradient ≥ 20 mmHg and seems to be a good predictor of NYHA status evolution as opposed to measured PPM. Predicted EOAi can be used in procedural planning to reduce the risk of PPM in both TAVR male and female patients.

B-61 | Incidence of Patient Prosthesis Mismatch (PPM) After ViV-TAVI and ViV-TAVI With Bioprosthetic Valve Fracture (BVF)

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is an effective treatment for degenerated bioprosthetic valves in high-risk patients. Unfortunately, patient prosthesis mismatch (PPM) remains an issue. PPM is known to impact functional status, valve longevity, morbidity and mortality. Bioprosthetic valve fracturing (BVF) is a method by which operators fracture the bioprosthetic valve allowing for greater expansion of the new valve or implantation of a larger valve. We sought to determine the incidence of PPM in patients undergoing ViV-TAVI and the safety of BVF. Patients who underwent ViV-TAVI at our institution from 2015-2022 were selected and divided into two groups (with BVF and without BVF). BVF was performed at the discretion of the operator. PPM severity was assessed as insignificant, moderate or severe. Moderate PPM was defined as an indexed effective orifice area (iEOA) <0.85 cm2/m2 (if BMI<30 kg/m2) or <0.70 cm2/m2 (if BMI>30 kg/m2). Severe PPM was defined as an iEOA <0.65 cm2/m2 (if BMI<30 kg/m2) or <0.55 cm2/m2 (if BMI>30 kg/m2). Measurements were taken by TTE on post operative day 1. All-cause mortality was assessed at 30-days and at 1-year. A total of 78 patients underwent ViV-TAVI, of which 25 patients had suboptimal gradients and were successfully treated with BVF. The mean age was 76.71 years old. The overall mean iEOA post ViV-TAVI was 0.69 ± 0.20 cm2/m2. Severe PPM was present in 43.4% that underwent ViV-TAVI, while only in 16% of patients that underwent ViV-TAVI with BVF. 1 patient required a permanent pacemaker in the BVF group. Amongst patients who underwent ViV-TAVI, 96.2% of patients were living at 30-days and 90.6% of patients were living at 1-year. Amongst patients who underwent ViV-TAVI with BVF, 100% of patients were living at 30-days and 96% of patients were living at 1-year. PPM was present more often in ViV-TAVI patients compared to ViV-TAVI with BVF. Short term mortality appears to be similar between groups and complications rates are low.

Figure of eight suture technique in aortic valve replacement decreases prosthesis-patient mismatch

BackgroundWhile the pledget suture technique has been the standard for surgical aortic. valve replacement (AVR), discussion continues regarding the possibility of the nonpledget suture technique to produce superior structural and hemodynamic parameters. This study aims to assess the effectiveness of the figure-of-eight suture technique in AVR, as determined by the incidence of prosthesis-patient mismatch (PPM).MethodsWe reviewed records of patients (N = 629) who underwent a surgical AVR procedure between January 2011 and July 2018 at a single institution. Indexed effective orifice area values and PPM incidence were calculated from implanted valve size and patient body surface area. Incidence of none, moderate, and severe PPM was compared across AVR suture techniques.ResultsA total of 570 pledget and 59 figure-of-eight patients were compared for incidence of PPM. Patients who received AVR with the pledget suture technique had significantly lower echocardiographic measurements of baseline ejection fraction than patients who had received AVR with the figure-of-eight suture technique (p = 0.003). Patients who received the figure-of eight suture had a 14% decrease in moderate PPM compared to patients who received the pledget suture (p = 0.022). Patients who received the figure-of-eight suture also had a significantly higher rate of no PPM (p = 0.044).ConclusionsThe use of the figure-of-eight suture technique in AVR can reduce the incidence of moderate PPM. While the pledget suture is the standard technique in AVR, the figure-of-eight suture technique may offer better structural and hemodynamic outcomes, especially for patients with a smaller aortic annulus.