Orifice Area Research Articles

Outcomes of K-Clip Implantation for Functional Tricuspid Regurgitation Accompanied with Persistent Atrial Fibrillation

Background: Atrial fibrillation (AF) has been identified as a risk factor for functional tricuspid regurgitation (FTR) in the absence of other known etiologies, although limited interventional options are available. K-Clip™, a novel transcatheter tricuspid annuloplasty device, is a clip-based annular plication approach for FTR. To date, no studies have investigated the short-term outcomes of K-Clip™ for patients with severe FTR associated with AF. Therefore, the aim of this study was to explore the feasibility and effectiveness of transcatheter annular repair with K-Clip™ for FTR in patients with persistent AF. Methods: Patients with FTR and persistent AF who underwent transcatheter annular repair with K-Clip™ at nine centers in China during the inclusion period were included (This study derived from Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip™ Transcatheter Annuloplasty System [TriStar study}). Baseline data, imaging results, and follow-up data were collected. Results: All 52 patients (23 men, 74.02 ± 7.03 years) received successful intervention, and the mean operation time and radian exposure were 2.64 ± 1.09 h and 133.33 ± 743.06 mGy, respectively. No death cases and a low major adverse event occurrence rate were reported in 30 days. A significant decrease in FTR was documented, and TR remained severe in only two patients (3.8%). The regurgitation volume decreased significantly, accompanied by a notable reduction in the effective regurgitation orifice area and tricuspid annulus diameter, which subsequently led to the reversal of right heart remodeling. Furthermore, a decrease in pulmonary artery systolic pressure and an increase in cardiac output were documented. Conclusions: Transcatheter annular repair with K-Clip™ showed favorable short-term prognosis and significant improvement in FTR in patients with severe FTR associated with persistent AF. K-Clip™ could be a novel option for that group of patients.

Long-Term Impact of Early Subclinical Leaflet Thrombosis After Transcatheter Aortic Valve Implantation.

Hypoattenuated leaflet thickening (HALT) after transcatheter aortic valve implantation (TAVI) detected on multidetector computed tomography (MDCT) is considered leaflet thrombosis. However, its impact on long-term clinical outcomes remains unclear. This study aimed to investigate the impact of early HALT detection after TAVI on long-term clinical outcomes and structural valve deterioration beyond 6 years. Of the 672 consecutive patients who underwent TAVI between 2013 and 2018, 448 were treated with either SAPIEN XT or SAPIEN 3 and underwent MDCT analysis within 30 days after TAVI. MDCT results and echocardiographic data were analyzed annually. HALT was detected in 68 (15.2%) of 448 eligible patients within 30 days after TAVI. No significant difference in effective orifice area was observed by echocardiography within 30 days after TAVI between the HALT and the non-HALT groups in SAPIEN XT (HALT vs. non-HALT: 1.62 ± 0.66 cm2 vs. 1.72 ± 0.43 cm2; p = 0.26) and in SAPIEN 3 (1.42 ± 0.35 cm2 vs. 1.45 ± 0.34 cm2; p = 0.63). No significant differences in all-cause mortality (52.9% vs. 60.0%; hazard ratio (HR): 1.19; 95% confidence interval (CI): 0.83-1.70; p = 0.3), stroke incidence (5.9% vs. 7.1%; HR: 1.06; 95% CI: 0.08-13.7; p = 0.97), heart failure rehospitalization (10.3% vs. 15.0%; HR: 2.3; 95% CI: 0.89-5.99; p = 0.09), and structural valve deterioration (14.7% vs. 17.9%; HR: 0.89; 95% CI: 0.45-1.73; p = 0.73) were observed between the HALT and the non-HALT groups during the median follow-up of 1872 (interquartile range; 1203-2468) days. HALT within 30 days was not associated with clinical outcomes or hemodynamic performance during long-term follow-up.

Utility of the average pixel intensity method for the detection of moderate-severe mitral regurgitation in comparison with the area of the regurgitant orifice

Abstract Background and purpose The "average pixel intensity" (API) method, which is applied to the continuous Doppler spectral signal in mitral regurgitation (MR), has been proposed as a new method for automated MR grading. The objective of this study is to compare the API method with the effective regurgitant orifice area (EROA) for the detection of moderate-severe or severe MR (grades III or IV/IV) using open-source software (ImageJ). Methods Prospective single-center study (n=267) including patients with different degrees of MI, with a subgroup with cardiac magnetic resonance (CRM, n=55). Of the total sample, API was measured in 148 patients, and EROA in 159. Significant MR by echocardiography was defined according to a multiparameter criterion (American Society of Echocardiography - ASE algorithm), and by CRM according to regurgitant volume (≥50 ml) or regurgitant fraction (≥40%). The association between quantitative parameters (API and EROA) and the diagnosis of moderate-severe MI according to each imaging technique (echocardiography vs CMR) was evaluated using ROC curves. Results The prevalence of significant MR was 34.1% by echocardiography, and 21.8% by CMR. In 24% of cases the MR mechanism was functional. The median [Q1-Q3] API was 112 [141-166] units, and EROA 0.17 [0.10-0.30] cm2. The correlation between API and EROA was low (r = 0.34; p < 0.01). For the diagnosis of moderate-severe MR, EROA performed better than API taking the ASE algorithm as a reference (AUC 0.89 vs 0.75; Figure 1A), but both parameters showed a similar performance when compared to the CMR criterion ( AUC 0.80 vs 0.75; Figure 1B). Conclusions The low correlation between the API method and EROA raises their potential complementarity in the diagnosis of MR. Regarding the ASE multiparametric criterion by echocardiography, the EROA is superior to the API (being a key element in this algorithm). However, both methods present a similar association with the diagnosis of moderate-severe MR by CMR, and the assessment of both parameters could improve the agreement between echocardiography and CMR.

Incremental clinical value of the regurgitant fraction assessed by three-dimensional echocardiography in patients with secondary tricuspid regurgitation

Abstract Background Differently from the effective regurgitant orifice area (EROA) and regurgitant volume (RegVol), RegFr directly accounts for the size and the function of the right ventricle (RV). Objectives To assess the relationship between regurgitant fraction (RegFr) evaluated using three-dimensional echocardiography (3DE) and the outcome in patients with secondary tricuspid regurgitation (STR). Methods 331 patients with at least mild STR were enrolled. RegFr was computed as ratio between the RegVol, calculated using the proximal isovolumic surface area (PISA) method by Doppler and the total stroke volume (SV) of the RV computed as difference between 3DE RV end-diastolic (RVEDV) and end-systolic (RVESV) volumes. To compare the association of EROA, RegFr and RegVol with outcome, we used a composite endpoint of heart failure hospitalization (HFH) and death for any cause. Results After a median follow-up of 20 months, 133 patients (40%) reached the combined endpoint. Among the quantitative parameters of STR severity, RegFr had the highest area under the curve at ROC analysis (AUC= 0.65, 95%CI: 0.59-0.71). At Cox regression, RegFr was associated with outcome both in the univariate analysis (HR 1.012, CI 1.003-1.020, p=0.006) and in multivariate, adjusted for several clinical and echocardiography correlates. By testing each single quantitative parameter of STR severity, only RegFr significantly increased the prediction of the basal model (p=0.007) and improved the risk-stratification of the patients on top of EROA (Net Reclassification Index: 0.2833, p=0.011). In the subgroup of patients with non-severe STR (i.e., EROA<0.4 cm²), the RegFr identified the patients with significantly higher risk of events (cumulative incidence of the combined endpoint of 73% in patients with EROA<0.4 cm2 but RegFr≥50% vs 51 % in patients with RegFr<50%, p= 0.02). Conclusions Compared to EROA and RegVol obtained by PISA method, RegFr obtained by 3DE was more strongly associated with the outcome of patients with STR.

Comparison of quantitative echocardiographic parameters for grading of mitral regurgitation severity for prediction of clinical outcome

Abstract Introduction Current recommendations favour the use of quantitative parameters for the assessment of mitral regurgitation (MR) severity and the effective regurgitant orifice area (EROA) derived from the proximal isovelocity surface area (PISA) method has been demonstrated as a predictor of outcome. Purpose The aim of our study was to compare the long-term predictive value of quantitative echocardiographic parameters, derived from the PISA method and volumetric method on clinical endpoints. Methods We retrospectively analysed 298 patients who consecutively underwent echocardiographic examination at out department in 2018 and had been diagnosed with more than mild MR. From the echocardiographic measurements we calculated the quantitative parameters (EROA, regurgitant volume (Rvol) and regurgitant fraction (RF)) by the PISA method and volumetric method (based on the Rvol calculated as a difference between total left ventricular stroke volume derived from the Simpson’s biplane planimetry and forward stroke volume assessed by the pulsed-wave Doppler left ventricular outflow tract method). The clinical outcome was death from any cause, hospitalization due to heart failure or mitral valve intervention in the period from the echocardiographic examination to the end of 2022. Results The study cohort comprised 169 (56%) patients with secondary MR, 103 (35%) with primary MR and 26 (9%) with combined etiology. Clinical endpoints were observed in 198 (66%) patients. Median time to the event was 732 (121-1578) days. Quantitative parameters by the PISA method better predicted the clinical outcome compared to quantitative parameters by the volumetric method (Figure A). RF-PISA had the biggest area under the curve (AUC 0.633, p < 0.001), followed by the EROA-PISA (AUC 0.626, p < 0.001), while the predictive values of quantitative parameters by the volumetric method were not significant (EROA: p= 0.109, Rvol: p=0.153, RF: p=0.156). By the PISA method, patients with RF≥50% had more adverse outcome compared to those with RF<50% (Figure B). By the volumetric method, however, the outcome was similar for both patients with RF≥50% or <50% (Figure B). In our cohort, the best cut-off value for the prediction of the clinical event was RF-PISA >46% (sensitivity 48%, specificity 76%) and EROA-PISA > 0.24 cm2 (sensitivity 41%, specificity 78%). Conclusions Quantitative parameters for grading MR severity by the PISA method provide better diagnostic accuracy for predicting the clinical outcome in comparison to quantitative parameters by the volumetric method. RF-PISA turned out as a good predictor for clinical outcome. Our results show that the fraction of regurgitation better defines the clinical significance of MR than the absolute values of quantitative parameters. Therefore, the RF should be reported as part of the quantitative assessment of MR severity.

Clinical impact of right atrium function on tricuspid regurgitation

Abstract Background tricuspid regurgitation (TR) is frequent, and its related systemic venous congestion is associated with mortality. Purpose This study aims to evaluate the role of right atrial (RA) function, measured using the strain technique, on the medium- to long-term clinical effects of tricuspid regurgitation (TR). Our primary objective was to analyze the impact of RA function, measured at baseline, on a composite endpoint consisting of death and/or hospitalization for predominantly right-sided heart failure. The secondary endpoints are hospitalizations, worsening of renal function, and an increase in diuretic dosage (DD). Methods We performed a single center, prospective, observational study regarding adult patients with tricuspid regurgitation and measurable effective regurgitant orifice area (EROA) and a state of hemodynamic stability that underwent a complete echocardiography and full cardiologic evaluation in our Institution, from January 2020 to February 2023. Those patients with acute HF, poor quality imaging, previous repair or prosthetic replacement of the tricuspid valve, and severe renal or hepatic insufficiency were excluded. Patients were assessed clinically at each follow up. Results 134 patients were included (females 62%, mean age 73 ± 13 years old). Median follow up was 23,5 months (12 - 34 months). TR was functional in 87% of cases and was more than moderate in 52% of cases. Mean RA strain was 18,7 ± 11,2%, and divided patients in low strain (LS) and high strain (HS). HS was associated with lower increase and frequently a decrease in DD (-5,5 ± 44,7 mg vs 20,8 ± 63,2 mg, p = 0,009) but no echocardiographic variable independently predicted an increase in DD. Patients with worsening renal function had significantly lower RA (16.7 ± 10.6% vs 20.7 ± 10.9%, p 0.042). LS independently predicted a worsening renal function (OR 3,07; 95% CI 1,026-9,2). RA strain was significantly lower in hospitalized patients (13.1 ± 8 vs 20.3 ± 11.4, p<0.001). Cox regression analysis showed a LS to be an independent predictor of the composite endpoint (adjusted HR 3.1, 95% CI 1.101 – 8.74) correcting for other clinical and echocardiographic variables. ROC curve analysis showed an RA strain cut-off of 18.5% to have a sensitivity of 79% and specificity of 56% in predicting the combined endpoint. Conclusions RA strain is associated with DD and LS patients have higher DD at follow up. RA strain is an independent predictor of worsening renal function. RA function measured by strain is an independent predictor of the composite endpoint of death and/or hospitalization.

Prognostic significance of tricuspid regurgitation grading using different echocardiographic approaches

Abstract Introduction Tricuspid regurgitation (TR) is routinely graded using quantitative and qualitative echocardiographic parameters. The current grading scheme consists of five TR grades and primarily incorporates vena contracta (VC) and effective regurgitation orifice area (EROA) assessed by the proximal isovelocity surface area (PISA) method. Additionally, an angle-corrected PISA method was proposed as the standard approach seem to underestimate especially ventricular TR. Purpose Since different measurements may lead to different TR severity grades, the present study aimed to evaluate the prognostic significance of TR grading using various approaches. Methods Hospitalized patients with heart failure (HF) according to current guidelines of the European Society of Cardiology (ESC) were enrolled from 2020 to 2022 (NCT04570098). Inclusion criteria comprised an echocardiographic examination up to three months prior to study participation. TR was graded into the categories moderate to torrential according to the recommended standard, including all quantitative and qualitative parameters as proposed by the guidelines, biplane VC, PISA EROA, and angle-corrected PISA EROA. Survival status was assessed during twelve-month follow-up. Cox regression analysis and log-rank test were used to evaluate the prognostic value of TR grades according to the different echocardiographic methods with the reference category none or mild TR. Results A total of 1003 HF patients were enrolled, including 66% with none or mild TR. The prevalence of moderate to torrential TR depending on the use of the different methods was as follows: 18% moderate, 10% severe, 2% massive, and 3% torrential TR according to quantitative and qualitative parameters; 12% moderate TR, 6% severe TR, 4% massive TR, and 4% torrential TR assessed by PISA EROA; 9% moderate TR, 6% severe TR, 3% massive TR, and 6% torrential TR according to angel-corrected PISA EROA; as well as 13% moderate TR, 14% severe TR, 4% massive TR, and 1% torrential TR measured by VC. During the study period, the overall-mortality rate reached 15%. A more severe TR was associated with an increase in mortality regardless of the TR grading approach (log-rank test p<0.001). As shown in Table 1, only TR grading based on VC consistently demonstrated an increased mortality risk across all severity grades. Conclusion There are various parameters for TR quantification used in clinical routine. Overall, a more severe TR was associated with an increase in all-cause mortality in HF patients. VC may be superior to PISA EROA and angle-corrected PISA EROA to differentiate the mortality risk of moderate to torrential TR.

TRIVO score: a new tool for predicting outcome in patients with secondary tricuspid regurgitation.

Abstract Background Predicting outcomes in patients with significant secondary tricuspid regurgitation (STR) is extremely challenging. Purpose This study sought to develop and validate the TRIVO-SCORE, utilizing advanced echocardiographic parameters, for predicting hospitalization for heart failure (HF) and mortality in moderate and severe STR patients. Methods We retrospectively studied 504 consecutive STR outpatients (mean age 74 ± 13 years, 44% men), randomly divided into derivation (49%) and validation (51%) cohorts. The primary endpoint included all-cause death and/or heart failure HF hospitalization, whereas the secondary endpoint focused on HF hospitalization or all-cause death. Score discrimination was assessed using time-dependent area under the receiver operating characteristic curve (AUROC), and calibration was evaluated via the Hosmer-Lemeshow goodness-of-fit test. In a subset of patients (162/504, 29%) with severe STR and comprehensive clinical, laboratory, and echocardiographic data, we compared TRIVO-SCORE with TRI-SCORE and TRIO-SCORE. Results After Multivariable Cox Regression Analysis, four variables were incorporated into the final model: moderate to severe chronic kidney disease (CKD, GFR <30 mL/min), effective Right Ventricular Ejection Fraction (eRVEF <20%), right Ventricular free wall longitudinal strain/pulmonary artery systolic pressure (RVFWLS/PASP) <0.48, and effective regurgitant orifice area (EROA) >0.41cm². The final score ranged from 0 to a maximum of 5 points. The TRIVO-SCORE demonstrated satisfactory performance in both the derivation cohort (AUROC 0.78, 95% CI 0.73-0.84) and the validation cohort (AUROC 0.71, 95% CI: 0.65-0.77) at 2-year. TRIVO-SCORE accurately predicted separate endpoints for HF hospitalization or mortality. Per each point of TRIVO-SCORE, the risk of experiencing the composite endpoint increased by 1.5 times (HR 1.55 [95% CI 1.35–1.80], p<0.001, for each stage increase). This progressive increase in risk persisted when stratifying the population into atrial and ventricular STR. The discrimination and calibration for mortality prediction were superior to those of TRI-SCORE (1) (AUROC 0.61) and TRIO-SCORE (2) (AUROC 0.57). Conclusions The TRIVO-SCORE, integrating both clinical and advanced echocardiographic variables, proved to be a robust tool for enhancing risk stratification in patients with moderate to severe STR, providing a stronger association with outcomes than previously validated risk scores.

PISA method correction by leaflet tethering angle and regurgitant jet velocity, and its association with outcomes in patients with secondary tricuspid regurgitation

Abstract Background Although the correction of the proximal isovelocity surface area (PISA) method has been shown to improve the accuracy of assessing the severity of secondary tricuspid regurgitation (STR), its clinical impact remains to be investigated. Purpose To compare the strength of the association of the quantitative parameters of STR severity obtained from the corrected and conventional PISA methods with outcomes in patients with either atrial- or ventricular STR. Methods We used both the conventional and corrected PISA method to obtain effective regurgitant orifice area (EROA and EROAc, respectively), regurgitant volume (RegVol and RegVolc, respectively), and regurgitant fraction (RegFr and RegFrc, respectively) in 519 consecutive patients (75±12 years, 44% men, 74% ventricular STR) with moderate and severe STR. The endpoint was a composite of heart failure hospitalization and all-cause death. Results EROAc, RegVolc, and RegFrc were significantly larger than EROA (bias= 21 mm2, Limits of agreement, LOA= 25 mm2), RegVol (bias= 18 mL, LOA= 18 mL), and RegFr (bias= 24%, LOA= 17%) (P < 0.001 for all). After a follow-up of 19±15 months, 210 patients reached the endpoint. Threshold values for an excess of events using the corrected PISA parameters were larger in patiets with ventricular (EROAc = 51 mm², RegVol = 42 mL) than atrial STR (EROAc = 46 mm², RegVolc = 30 mL), except the RegFr that was significantly smaller in patients with ventricular STR (56% vs. 69%). Using time-dependent ROC curves, the AUCs of the parameters obtained from the corrected PISA were more closely associated with outcomes at two years than those obtained with the conventional PISA: EROAc vs. EROA (0.62 vs. 0.60, p<0.001), RegVolc vs. RegVol (0.63 vs. 0.62, p=0.001), and RegFrc vs. RegFr (0.66 vs. 0.63, p<0.001) in patients with ventricular STR. Conversely no significant differences between AUCs were detected in patients with atrial STR. In both univariable and multivariable analyses, both EROA and EROAc, RegVol and RegVolc, or RegFr and RegFrc consistently emerged as independently associated with outcomes in patients with ventricular STR (p<0.001 for all). Conversely, in patients with atrial STR, although EROA and EROAc retained their independent predictive power, neither uncorrected nor corrected RegVols and RegFrs were found to be independent predictors of outcomes after multivariable adjustment. Conclusions Correcting the PISA method for the leaflet tethering angle and the velocity of the regurgitant jet provides larger quantitative parameters of STR severity. In patients with ventricular STR, the parameters obtained with the corrected PISA method are more closely associated with those obtained with the conventional PISA.

Prognostic implications of secondary tricuspid regurgitation dynamic trends in acute heart failure

Abstract Background The response of secondary tricuspid regurgitation (STR) to therapeutic management in acute heart failure (HF) is variable. STR improvement may indicate reverse right ventricular remodeling and response to treatment. The dynamic trends of STR during HF hospitalization and their prognostic relevance remain unexplored. Methods All consecutive patients hospitalized for acute HF underwent echocardiographic assessment within 24 hours from admission and 24 hours prior to discharge. Patients were divided into 3 groups; No/mild STR on admission, significant STR on admission that improved on discharge (Improved TR), and significant STR on admission without improvement on discharge (Non-improved TR). All-cause death and HF hospitalization was the composite primary end-point. Results Out of 401 patients, 285 (71.1%) presented with significant STR on admission; of these 136 (33.9%) demonstrated TR improvement on discharge (Figure 1A). Chronic HF, RV free wall longitudinal strain (LS) and effective regurgitant orifice area (EROA) on admission were independent predictors for TR improvement (Figure 1B). Spline curve analyses indicated that the STR subgroup with RV free wall LS <-14.2 % and EROA <0.34 cm2 on admission were most likely to achieve TR improvement on discharge. After a median follow up of 6 months (interquartile range, 2.3-9.8), 141 (35.2%) patients reached the primary endpoint. Patients with Non-improved TR showed higher cumulative event rates compared to the other 2 groups (No/mild TR: 20.7%, Improved TR: 28.7%, Non-improved TR: 52.3%, Log-rank p <0.001) (Figure 1C). Non-improved TR was independently associated with the composite outcome (hazard ratio 2.15 [95% CI, 1.37–3.38]; p <0.001). Conclusion The dynamic trends of STR carry a clinically relevant value in acute HF. Absence of STR improvement during hospitalization indicates worst long-term survival. Figure 1: Graphical Abstract

Association with outcomes of the planimetry of vena contracta area by 3-dimensional color Doppler echocardiography in patients with secondary tricuspid regurgitation

Abstract Background The cut-off value for defining severe secondary tricuspid regurgitation (STR) using the planimetry of color Doppler three-dimensional echocardiography (3DE) vena contracta area (VCA) has been determined in previous studies based on its correlation with the values of the effective regurgitant orifice area (EROA), obtained using the proximal isovolumic surface area (PISA) method, in patients with severe STR. However, the association of VCA with outcomes has not been examined in these studies. Purpose We sought to 1) identify the cut-off value of 3DE VCA associated with an increased risk of death for any cause or heart failure hospitalizations (HF) in patients with STR; 2) test if the planimetry of 3DE VCA may improve the risk stratification over the quantitative parameters of STR severity. Methods Retrospective analysis of patients with STR consecutively enrolled in the FUTURE 3DECHO study who had good quality 3DE dataset for VCA planimetry. Results We selected 184 patients (76±13 years, 43% women). According to the guideline-recommended multiparametric approach, 15% of the patients had mild, 51% moderate, 22% severe, and 12% massive STR. The mean 3DE VCA was 0.72±0.41 cm2 and it increased significantly with the severity of STR. Among all the quantitative parameters of STR severity, the strongest correlation of 3DE VCA was found with EROA by PISA (Spearman: 0.63, p < 0.001). Using spline curve analysis, a 3DE VCA of 0.65 cm2 was identified as the threshold value associated with increased risk of experiencing the composite endpoint in the whole population (Figure 1A). At univariate analysis, a 3DE VCA > 0.65 cm2 carried a 4-fold increased risk of combined events and it also stratified the risk in patients with EROA < 0.4 cm2 (Figure 1B). When added to a multivariable model including right atrial volume, right ventricular ejection fraction, pulmonary arterial systolic pressure, STR EROA and regurgitant volume, VCA increased significantly the predictive power of the model and mainteined its independent correlation with outcomes (HR: 1.011, CI 95%: 1.003-1.019, P=0.007; X2 of models: 44 vs 39, p value <0.001) (Figure 2). Conclusion 3DE VCA has independent and incremental value over the other parameters of severity for predicting the risk of events in patients with STR. 3DE VCA> 0.65 cm2 identified STR patients with EROA< 0.4 cm2 at higher risk of experiencing the composite endpoint of death and HF. Figure 1 A and B Figure 2. Cox Regression multivariate

Clinical value of preoperative cardiac magnetic resonance imaging and echocardiography to identify post-operative left ventricular dysfunction in primary mitral regurgitation

Abstract Background Post-operative left ventricular (LV) dysfunction remains a common adverse consequence in patients with primary mitral regurgitation (MR) undergoing mitral valve (MV) surgery. Currently, cardiac magnetic resonance imaging (CMR) is a very useful imaging modality that complements echocardiography (Echo) in providing accurate grading of MR severity in these patients. Yet it remains unclear whether the consideration of CMR-assessed LV volumes and function would offer advantages over conventional echocardiographic LV measurements in identifying patients at risk of LV systolic dysfunction after MV surgery. Purpose We sought to compare the relationship between CMR- or Echo-assessed preoperative LV volumetric and function measurements and the occurrence of post-operative LV systolic dysfunction in patients with chronic significant primary MR undergoing MV surgery. Methods The study population consisted of 214 patients (median age: 59 years, 20% women) with chronic significant primary MR due to MV prolapse or flail who underwent echocardiography and CMR in 2 tertiary centers, between 2005 and 2022, before MV repair surgery. The endpoint was the occurrence of post-operative LV systolic dysfunction (defined as LV ejection fraction [EF] < 50%) at echocardiographic follow-up when available. ROC curves were used to evaluate relations between preoperative Echo or CMR characteristics and post-operative LV dysfunction. Side-by-side comparisons of AUCs were done using DeLong’s tests. Results At echocardiographic follow-up, 40 patients (19%) had post-operative LV dysfunction, with a median follow-up time of 8.6 months (interquartile range: 6.7 – 12.5 months) after MV surgery. Compared with those with normal LV function, patients with post-operative LV dysfunction exhibited higher absolute and indexed (ind) LV end-systolic diameters (ESD) and volumes (ESV) (all p<0.043, Figure 1). These patients also showed lower preoperative CMR-assessed LVEF (p=0.004), while Echo-LVEF did not show a significant relationship (p=0.071). Additionally, no relationship was found between MR quantitative parameters (regurgitant orifice area, volume, or fraction) and post-operative LV function (all p>0.247). The AUCs of the imaging preoperative characteristics tested (LVESD, indLVESD, Echo-indLVESV, CMR-indLVESV, Echo-LVEF, CMR-LVEF) numerically ranged from 0.59 (0.50-0.69), p=0.034 (Echo-LVEF) to 0.69 (0.60-0.77), p<0.001 (Echo-indLVESD, Figure 2). No significant differences were found in the side-by-side comparisons of the AUCs (all p>0.118). Conclusion In this series of patients with chronic significant primary MR who underwent MV surgery, conventional preoperative Echo and CMR LV measurements had similar diagnostic value in detecting post-operative LV systolic dysfunction. Our results indicate that both echocardiography and CMR are valuable imaging tools for identifying primary MR patients at risk of post-operative LV dysfunction. Figure 1 Figure 2

Impact of right ventricular function on outcome in low-risk secondary tricuspid regurgitation according to effective regurgitant orifice area

Abstract Background The threshold value of the effective regurgitant orifice area (EROA) that identifies patients with secondary tricuspid regurgitation (STR) at high risk of events during follow-up remains unclear. Purpose Our study aimed to identify the threshold value of the EROA defining patients with STR at high-risk of events during follow-up and to evaluate the impact of right ventricular (RV) remodeling in modulating the outcome of low-risk STR patients according to EROA. Methods 513 consecutive outpatients with STR were included. Using the threshold value derived by spline curves, we divided our cohort into two groups: low- (EROA≤ 0.47cm2) and high- (EROA> 0.47cm2) risk STR patients. The endpoint was a composite of heart failure hospitalization and death. Results At 18±15 months from enrolment, 195 patients (38%) reached the endpoint. The Kaplan-Meier curves demonstrated a higher rate of events for high-risk patients (54±6% vs 30±7%, p <0.0001). EROA> 0.47 cm2 was associated with a 2-fold increased risk of experiencing the outcome (Hazard Ratio [HR]: 2.08, 95% Confidence Interval [CI] 1.56-2.77, p<0.0001). Patients with atrial STR had a significantly lower threshold value (0.44 cm²) than patients with ventricular STR (0.49 cm²). In multivariate Cox regression analysis, EROA remained independently associated with the composite endpoint (adjusted HR: 1.01, 95% CI 1.00-1.02, p<0.0001) both in the entire cohort and in high-risk patients. Patients with low-risk STR were associated with a dismal prognosis only if they had dilated or dysfunctioning RV. In patients with EROA≤ 0.47cm2, the event rate at two years for RV end-diastolic volume >90 mL/m2, RV end-systolic volume (RV ESV) >46 mL/m2, RV ejection fraction <45% and RV forward stroke volume/RV ESV< 0.40 were respectively: 42±4%, 51±4%, 44±4%, and 47±4%). Conclusions Our results refine the independent association between STR severity assessed by EROA and outcomes. In patients with low-risk STR, the assessment of RV function and RV-PA coupling may improve the patient’s risk prediction, demonstrating a clinically relevant link between STR severity and RV geometry and function.

Image-Based Analysis of Correlation Between Valve Stent Deformation and Valve Function in Transcatheter Aortic Valve Replacement.

Currently, there remains a paucity of research on the deformation and valve function of transcatheter heart valves (THV) in patients with aortic regurgitation (AR) following transcatheter aortic valve replacement (TAVR). This study aimed to thoroughly explore the correlation between THV deformation and postoperative hemodynamics in these patients. In this study, we assessed 39 AR patients treated with the J-Valve THV system during TAVR. We utilized postoperative cardiac-enhanced computed tomography angiography (CTA) to examine the extent of stent deformation, correlating these measurements with concurrent echocardiographic data. Among patients with AR, the J-Valve exhibited three distinct configurations: rectangular, trapezoidal, and inverted trapezoidal shapes. The rectangular configuration showed a trend toward a larger effective orifice area (EOA) compared to the trapezoidal and inverted trapezoidal configurations (rectangular: 2.20 ± 0.11 cm², trapezoidal: 1.88 ± 0.08 cm², inverted trapezoidal: 2.04 ± 0.08 cm²; p = 0.068). Stratified analysis of the degree of inclined commissural posts indicated that THVs with all three commissural angles < 5° exhibited the highest standard EOA (sEOA). An increase in the number and degree of inclined commissural posts correlated with a decrease in sEOA. Furthermore, a higher EOA was observed when the expansion in the mid and transition level exceeded 80%. During the TAVR procedure, ensuring sufficient expansion in the mid and transition level of the stent, maintaining the stent in a rectangular configuration, and avoiding tilting of the commissural posts contribute to achieving favorable postoperative hemodynamics.

Bioprostheses and Mechanical Prostheses for Aortic Valve Replacement in Patients Aged 50 to 65 Years Offer Similar Long-Term Survival Rates

Background: Aortic valve replacement (AVR) is the definitive therapy for patients with severe aortic valve stenosis (AoS). The aim of this work is to compare the effect of a mechanical prosthesis (MP) and a bioprosthesis (BP) on the survival of patients aged 50–65 years after AVR. Methods: The retrospective analysis included 276 patients aged 50 to 65 years who had undergone isolated AVR for AoS; 161 patients were implanted with an MP and 115 with a BP. Patient survival, adjusted for age, gender and risk parameters affecting survival, was assessed. A subgroup analysis was performed on the 208 patients with a modern valve (prosthesis models that are no longer used in clinical practice were removed from the sample). Results: After adjusting for risk factors for overall survival as well as for age and sex, the implantation of an MP did not have a significant effect on overall survival in comparison to a BP, at a median follow-up of 10.3 years (p = 0.477). The size of the MP had no significant effect on overall survival either (HR: 1.29; 95%CI: 0.16–10.21; p = 0.812). However, the indexed effective orifice area of the BP had a positive effect on overall survival (HR: 0.09; 95%CI: 0.01–0.78; p = 0.029). Conclusions: The estimated survival of patients aged between 50 and 65 years after implantation of a BP with a sufficiently large indexed effective orifice area may exceed that of patients with an MP.

Parametric finite element modeling of reinforced polymeric leaflets for improved durability.

Hyaluronic acid-enhanced polyethylene polymeric TAVR shows excellent in vivo anti-calcific, anti-thrombotic, and in vitro hydrodynamic performance. However, during durability testing, impact wear and fatigue cause early valve failure. Heart valve durability can be improved by strengthening the leaflet with fiber reinforcement. A thin plastic sheet is assembled into a cylindrical form by welding two ends, which never fails during accelerated wear testing (ISO 5840-2005). The weld at the commissure post region of the leaflet (ROI) is mechanically stronger than the rest of the leaflet, which protects this region. Braided polyester fibers are embedded on the leaflet regions of the commissure post perpendicular to the valve circumference, mimicking the weld but at a much higher strength. Leaflet durability skyrockets from a few million cycles to 73 million and comparable hemodynamics performances. The entire cardiac cycle of the heart valve with embedded fibers of varying angles, lengths, and numbers is simulated in Finite Element Analysis (FEA) to study their effects on leaflet maximum principal stress and leaflet opening dynamics. Horizontal fibers wrap the leaflet 360° to relax the leaflet completely during peak diastolic. However, the leaflet has a higher coaptation gap and lower geometric orifice area (GOA). The heart valve with embedded horizontal fibers is physically manufactured and tested in an in vitro flow loop and wear tester, which shows improved durability but compromised hemodynamics. The parametric study further predicts that 12 mm long fibers covering only the commissure post region of the leaflet have low principal stress, maximum GOA, and fastest opening as the spring-like fibers help leaflet opening.

Aortic Annular Enlargement: Y-Incision Rationale, Technique, and Outcomes.

Trials comparing transcatheter (TAVR) and surgical aortic valve replacements (SAVR) have shown that in patients with annuli <26 mm, SAVR had negative hemodynamic and clinical outcomes. Recently, studies revealed that the effective orifice diameter of surgical prosthetic valves is 5-7 mm smaller than the labeled valve size. To improve outcomes of SAVR, the Y-incision aortic annular enlargement (AAE) enlarges the surgical aortic annulus to accommodate a prosthetic valve 3-4 sizes larger with an effective orifice area that matches the patient's native annulus. This review discussed when and how the Y-incision AAE should be performed. OVID MEDLINE, OVID Embase, and Cochrane Library were searched with terms that included "Y-incision aortic annular enlargement," "valve sizes," and "long-term survival." The search included publications after 2020. The reference lists of included studies were reviewed to retrieve additional studies. In patients with matched native annular sizes, AAE significantly improved midterm survival without increasing perioperative complications. Patients treated with a larger valve had significantly better long-term survival and small valve sizes were significant risk factors for operative and long-term mortality. Compared with patients treated with a Nicks or Manougian procedure, the hemodynamics in patients treated with Y-incision AAE were significantly better. Y-incision AAE could be routinely considered for patients with a normal annulus (17-25 mm) undergoing SAVR.

Right Ventricular Function and Outcomes Stratified by the Effective Regurgitant Orifice Area in Secondary Tricuspid Regurgitation.

In patients with moderate and severe secondary tricuspid regurgitation (STR), the effective regurgitant orifice area (EROA), corrected using the proximal isovelocity surface area (PISA) method for tricuspid valve leaflet tethering and low TR jet velocities, has an unclear threshold for identifying high-risk patients. This study aimed to establish a risk-based EROA cutoff and assess the impact of right ventricular (RV) remodeling on outcomes in low-risk STR patients according to EROA. We included 513 consecutive outpatients (age 75±13 years, 47% male) with moderate and severe STR. Patients were categorized by a spline-derived EROA threshold into low (≤0.47cm2) and high (>0.47cm2) risk groups. The primary endpoint was a composite of heart failure hospitalization and death. Over a follow-up period of 18±15 months, 195 patients reached the composite endpoint. Kaplan-Meier analysis showed a significantly higher event rate in high-risk patients (54±6% vs. 30±7%, p <0.0001). An EROA>0.47cm2 was associated with a two-fold increased risk (Hazard Ratio [HR]:2.08, 95% Confidence Interval [CI]: 1.56-2.77, p<0.0001). This association remained significant after multivariable adjustment (adjusted HR:1.01, 95%CI:1.00-1.02, p<0.0001). In the low-risk group, poor outcomes were linked to RV dilation or dysfunction. Two-year event rates for RV parameters were as follows: RV end-diastolic volume>90 mL/m2 (42±4%), RV end-systolic volume>46 mL/m2 (51±4%), RV ejection fraction<45% (44±4%), and RV forward stroke volume/RV end-systolic volume<0.40 (47±4%). EROA independently predicts outcomes in STR. For low-risk patients by EROA, evaluating RV function and RV-PA coupling enhances risk stratification.

Three-Year Outcomes With a Supra-Annular, Self-Expanding Bioprosthesis and a Pericardial Wrap-The FORWARD PRO Study.

The self-expanding, supra-annular Evolut valve is an established platform for Transcatheter Aortic Valve Implantation (TAVI). Evolut PRO introduced an outer sealing wrap to mitigate paravalvular leakage. We evaluated the 3-year clinical outcomes and valve performance of the Evolut PRO in standard clinical practice for severe aortic stenosis (AS) patients at intermediate or higher risk for surgery. The FORWARD PRO prospective, single-arm, multicentre, post-market clinical study enrolled 638 patients with native aortic valve stenosis or failed surgical bioprosthetic aortic valve undergoing TAVI, at intermediate or high risk, with the Evolut PRO valve. Clinical and serial echocardiographic outcomes were followed-up for 3 years. TAVI using Evolut PRO was attempted in 629 AS patients (implanted in 97%) (mean age 81.7 years; STS PROM score, 4.7%). At 3 years all-cause mortality was 25.0%, disabling stroke 6.5% (all-cause mortality or disabling stroke, 28.5%) and rate of new permanent pacemaker implantation 24.7%. Excellent valve haemodynamics were maintained (mean gradient 8.8 ± 4.7 mm Hg; mean effective orifice area 2.0 ± 0.5 cm2) at 3 years. In a paired analysis of patients with ≥ mild paravalvular leakage (PVL) at discharge, more than two-thirds demonstrated improved PVL at 3 years. Patients with ≥ mild PVL at discharge had higher median total calcium volume than those with no/trace PVL (p < 0.001). In clinical practice TAVI with the Evolut PRO valve is associated with favorable clinical outcomes and excellent haemodynamic performance out to 3 years. The observation of improvements in PVL over time warrants further research.

Clinical feasibility study of transcatheter edge-to-edge mitral valve repair in dogs with the canine V-Clamp device

ObjectiveTo determine procedural feasibility, safety, and short-term efficacy in dogs with severe degenerative mitral regurgitation (MR) undergoing transcatheter edge-to-edge repair (TEER) with a canine-specific device.DesignProspective, single-arm (uncontrolled), single-institution clinical feasibility study.AnimalsFifty client-owned dogs with severe degenerative MR operated over a 28-month period.MethodsTEER was performed using the canine mitral V-Clamp via a transapical approach using transesophageal echocardiographic and fluoroscopic guidance. Indices of MR severity were determined by echocardiography the day before and 2 to 3 days after the procedure.ResultsProcedural feasibility was 96% based on delivery of at least one device in 48 of 50 dogs. There were no procedural deaths. Procedural safety was 96% based on survival to hospital discharge in 48 of 50 dogs. Euthanasia in 2 dogs prior to hospital discharge was due to damage of the mitral valve and worsened MR after the procedure. Device-related adverse event rate was 6.3% based on 3 events (single-leaflet device detachment, locking failure, locking failure with device embolization) in 59 implanted devices. All three events were nonfatal and successfully treated with a second device. Median regurgitant volume (mL/kg) decreased (p &amp;lt; 0.001) from 2.3 [1.9, 3.1] to 1.1 [0.3, 1.8]. Median effective regurgitant orifice area (cm2/m2) decreased (p &amp;lt; 0.001) from 0.60 [0.40, 0.80] to 0.25 [0.10, 0.50].Conclusion and clinical importanceInitial feasibility results support continued development of TEER as a procedurally feasible, relatively low-risk, and low morbidity treatment for degenerative MR in dogs. Operator experience and case selection are likely to be important components of success of this technique. Evidence of short-term efficacy is promising but needs to be verified with longer-term follow up.