Larger Effective Orifice Area Research Articles

Transcatheter aortic valve replacement achieves similar predicted effective orifice area to surgical aortic valve replacement in bicuspid aortic stenosis

BackgroundStudies comparing transcatheter and surgical aortic valve replacement (TAVR and SAVR) for patients with trileaflet aortic stenosis (AS) have found similar or larger effective orifice area (EOA) for TAVR prostheses. To our knowledge, no studies have compared EOA in patients undergoing TAVR versus SAVR for bicuspid AS. MethodsWe retrospectively compared prosthetic valvular sizing and predicted EOA for patients with bicuspid AS undergoing TAVR or SAVR at our institution between January 1, 2016, and December 31, 2021. We excluded patients undergoing procedures for indications other than AS and those without a pre-procedural gated Chest CT. Comparisons included demographics, comorbidities, annular size, prosthetic valve size, predicted EOA and prosthesis-patient mismatch (PPM) for TAVR (N = 78) and SAVR (N = 74) cohorts. ResultsTAVR patients had smaller pre-procedural annular area (501.7 mm2 vs. 571.8 mm2, p < 0.05) and annular perimeter (80.6 mm vs. 86.5 mm, p < 0.05), but larger mean implanted prosthetic valve size (26.4 mm vs 24.2 mm, p < 0.001) compared to SAVR patients. No differences were observed in predicted EOA, predicted EOA indexed to patient body surface area (EOAi), or predicted PPM grade between TAVR and SAVR groups, including in cohorts sorted by pre-procedural annular size. ConclusionsFor bicuspid AS patients undergoing aortic valve replacement, TAVR achieves similar predicted EOA to SAVR. These data support the use of TAVR in selected patients with bicuspid AS and can inform heart team discussions.

Comparison of outcomes of self-expanding versus balloon-expandable valves for transcatheter aortic valve replacement: a meta-analysis of randomized and propensity-matched studies

BackgroundThe postoperative outcomes of transcatheter aortic valve replacement (TAVR) with the new generation of self-expanding valves (SEV) and balloon-expandable valves (BEV) remain uncertain.MethodsWe conducted a meta-analysis based on randomized controlled trials (RCTs) and propensity score-matched (PSM) studies to evaluate the performance of the new generation TAVR devices, with a focus on Edwards SAPIEN 3/Ultra BEV, Medtronic Evolut R/PRO SEV, and Boston ACURATE neo SEV. Our primary endpoints were mortality and complications at both 30 days and one year post-operation.ResultsA total of 4 RCTs and 14 PSM studies were included. Our findings showed no significant difference between SEV and BEV regarding 30-day and 1-year mortality rates. ACURATE SEV required less permanent pacemaker implantation (PPI) at 30-day as compared to SAPIEN BEV, while Evolut SEV required a higher rate of PPI than SAPIEN BEV. The incidence of stroke, major or life-threatening bleeding (MLTB), major vascular complications (MVC), coronary artery obstruction (CAO) and acute kidney injury (AKI) did not differ significantly between the two groups. SEV had a larger effective orifice area (EOA) and lower mean transvalvular gradients (MPG) compared to BEV. However, there was an increased risk of paravalvular leakage (PVL) associated with SEV.ConclusionsIn terms of 30-day mortality, stroke, bleeding, MVC, AKI, CAO, and one-year mortality, there was comparability between the two valve types following TAVR. SEV was associated with better hemodynamic outcomes, except for a higher incidence of PVL. Compared to SAPIEN BEV, ACURATE SEV had a lower risk of PPI at 30 days, while Evolut SEV was associated with a higher risk of PPI. These findings underscore the importance of personalized valve selection.

Rapid-Deployment Aortic Valve Replacement: Patient Selection and Special Considerations.

Sutureless or rapid deployment valves in the setting of aortic valve replacement (AVR) is an emerging surgical technique using the transcatheter valve technology, which may lead to reduction in cross-clamp time and potentially better hemodynamics compared to a stented bioprosthetic valve. The absence of subannular pledgets results to excellent hemodynamic performance with reduced turbulent flow and larger effective orifice area. However, complications from both surgical and transcatheter AVR may still occur and impact survival. The incidence of paravalvular leakage and permanent pacemaker implantation are not low. Although technical modifications can improve these outcomes, there is a learning curve effect. Therefore, technical and anatomical considerations as well as better patient selection are paramount for better outcomes. In this review, we discuss the use of sutureless or rapid deployment valves in setting of (1) complex procedures, (2) minimally invasive AVR, and (3) small aortic annulus. The advantage of sutureless or rapid deployment valves in terms of mortality remains to be clarified; therefore, it is necessary to accumulate long-term outcomes in an appropriate patient cohort.

5-Year Outcomes With Self-Expanding vs Balloon-Expandable Transcatheter Aortic Valve Replacement in Patients With Small Annuli

BackgroundSelf-expanding transcatheter heart valves (THVs) are associated with better echocardiographic hemodynamic performance than balloon-expandable THVs and are considered preferable in patients with small annuli. ObjectivesThis study sought to compare 5-year outcomes between self-expanding vs balloon-expandable THVs in severe aortic stenosis (AS) patients with small annuli. MethodsConsecutive severe AS patients with an aortic valve annulus area <430 mm2 who underwent transcatheter aortic valve replacement (TAVR) with either the CoreValve Evolut (Medtronic) or SAPIEN (Edwards Lifesciences) THV between 2012 and 2021 were enrolled from the Bern TAVI registry. A 1:1 propensity-matched analysis was performed to account for baseline differences between groups. ResultsA total of 723 patients were included, and propensity score matching resulted in 171 pairs. Technical success was achieved in over 85% of both groups with no significant difference. Self-expanding THVs were associated with a lower transvalvular gradient (8.0 ± 4.8 mm Hg vs 12.5 ± 4.5 mm Hg; P < 0.001), a larger effective orifice area (1.81 ± 0.46 cm2 vs 1.49 ± 0.42 cm2; P < 0.001), and a lower incidence of prosthesis-patient mismatch (19.7% vs 51.8%; P < 0.001) than balloon-expandable THVs. At 5 years, there were no significant differences in mortality (50.4% vs 39.6%; P = 0.269) between groups. Disabling stroke occurred more frequently in patients with a self-expanding THV than those with a balloon-expandable THV (6.6% vs 0.6%; P = 0.030). Similar results were obtained using inverse probability of treatment weighting in the Bern TAVI registry and the nationwide Swiss TAVI registry. ConclusionsThe echocardiographic hemodynamic advantage of self-expanding THVs was not associated with better clinical outcomes compared with balloon-expandable THVs up to 5 years in patients with small annuli. (Swiss TAVI Registry; NCT01368250)

Core Lab Adjudication of the ACURATE neo2 Hemodynamic Performance Using Computed-Tomography-Corrected Left Ventricular Outflow Tract Area.

(1) Background: Hemodynamic assessment of prosthetic heart valves using conventional 2D transthoracic Echocardiography-Doppler (2D-TTE) has limitations. Of those, left ventricular outflow tract (LVOT) area measurement is one of the major limitations of the continuity equation, which assumes a circular LVOT. (2) Methods: This study comprised 258 patients with severe aortic stenosis (AS), who were treated with the ACURATE neo2. The LVOT area and its dependent Doppler-derived parameters, including effective orifice area (EOA) and stroke volume (SV), in addition to their indexed values, were calculated from post-TAVI 2D-TTE. In addition, the 3D-LVOT area from pre-procedural MDCT scans was obtained and used to calculate corrected Doppler-derived parameters. The incidence rates of prosthesis patient mismatch (PPM) were compared between the 2D-TTE and MDCT-based methods (3) Results: The main results show that the 2D-TTE measured LVOT is significantly smaller than 3D-MDCT (350.4 ± 62.04 mm2 vs. 405.22 ± 81.32 mm2) (95% Credible interval (CrI) of differences: −55.15, −36.09), which resulted in smaller EOA (2.25 ± 0.59 vs. 2.58 ± 0.63 cm2) (Beta = −0.642 (95%CrI of differences: −0.85, −0.43), and lower SV (73.88 ± 21.41 vs. 84.47 ± 22.66 mL), (Beta = −7.29 (95% CrI: −14.45, −0.14)), respectively. PPM incidence appears more frequent with 2D-TTE- than 3D-MDCT-corrected measurements (based on the EOAi) 8.52% vs. 2.32%, respectively. In addition, significant differences regarding the EOA among the three valve sizes (S, M and L) were seen only with the MDCT, but not on 2D-TTE. (4) Conclusions: The corrected continuity equation by combining the 3D-LVOT area from MDCT with the TTE Doppler parameters might provide a more accurate assessment of hemodynamic parameters and PPM diagnosis in patients treated with TAVI. The ACURATE neo2 THV has a large EOA and low incidence of PPM using the 3D-corrected LVOT area than on 2D-TTE. These findings need further confirmation on long-term follow-up and in other studies.

Impact of valvuloarterial impedance on left ventricular reverse remodeling after aortic valve neocuspidization

BackgroundAortic valve neocuspidization (AVNeo) has emerged as a promising aortic valve procedure, and is expected to have a larger effective orifice area (EOA) than commercially available bioprostheses. It is, however, unclear which indices could facilitate left ventricular (LV) reverse remodeling after AVNeo. The aim of this study is to verify the impact of global left ventricular afterload on the LV reverse remodeling following AVNeo.MethodsData-available consecutive 38 patients (median age, 77; interquartile range, 72.8–82.0) undergoing AVNeo for severe aortic stenosis were enrolled in this study. Preoperative and the last follow-up echocardiographic data were retrospectively analyzed including the valvuloarterial impedance (Zva), a marker of global LV afterload. Reduction in LV geometry index (LVGI) and relative wall thickness (RWT) were used as an indicator for LV reverse remodeling.ResultsThe Zva reduced in 24 patients (63.2%) during the follow-up period (median, 12 months). Reduction in Zva significantly correlated to improvement of LV geometry (LVGI (r = 0.400, p = 0.013) and RWT (r = 0.627, p < 0.001)), whereas increase in EOA index did not significantly correlate to LVGI (r = 0.009, p = 0.957), or RWT (r = 0.105, p = 0.529)). The reduction in Zva was the multivariate predictor of LV reverse remodeling.ConclusionsLow global LV afterload led to significant LV reverse remodeling even after AVNeo, which could achieve better valve performance than the conventional bioprostheses.

30-Day and 1-Year Outcomes With HYDRA Self-Expanding TranscatheterAortic Valve: The Hydra CE Study.

This study sought to evaluate the 30-day and 1-year safety and performance of the Hydra transcatheter aortic valve (THV) (in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk. The Hydra THV is a novel repositionable self-expanding system with supra-annular bovine pericardial leaflets. The Hydra CE study was a premarket, prospective, multicenter, single-arm study conducted across 18 study centers in Europe and Asia-Pacific countries. The primary endpoint was all-cause mortality at 30days. All endpoints were adjudicated by an independent clinical events committee. A total of 157 patients (79.2 ± 7.1 years of age, 58.6% female; Society of Thoracic Surgeons score 4.7 ± 3.4%) were enrolled. Successful implantation was achieved in 94.3% cases. At 30days, there were 11 (7.0%) deaths, including 9 (5.7%) cardiovascular deaths, of which 5 (3.2%) were device related. At 1 year, there were 23 (14.6%) deaths, including 13 (8.3%) cardiovascular deaths. At 30days, there were significant improvement of effective orifice area (from 0.7 ± 0.2cm2 to 1.9 ± 0.6cm2) and mean aortic valve gradient (from 49.5 ± 18.5mmHg to 8.1 ± 3.7mmHg), which were sustained up to 1 year. Moderate or severe paravalvular leak was observed in 6.3% of patients at 30days and 6.9% of patients at 1 year. The rate of new permanent pacemaker implantation was 11.7% at 30days and 12.4% at 1 year. The Hydra CE study demonstrated that transcatheter aortic valve replacement with Hydra THV offered favorable efficacy at 1 year, providing large effective orifice area and low transvalvular gradient as well as acceptable complication rates with regard to new permanent pacemaker and paravalvular leak. (A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve; NCT02434263).

Comparison of valve durability among different transcatheter and surgical aortic valve prostheses: a network meta-analysis

Abstract Background Durability of different transcatheter heart valve (THV) is critical as the indication of transcatheter aortic valve replacement (TAVR) expands to patients with longer life-expectancy. Purpose We aimed to compare the durability of THV systems (balloon-expandable [BE] and self-expandable [SE]) and surgical aortic valve replacement (SAVR) prosthesis. Methods PUBMED and EMBASE were searched through February 2021 for randomized trials investigating parameters of valve durability after TAVR and/or SAVR in severe aortic stenosis. A network meta-analysis using random-effect model was performed. Synthesis was performed with 5-year follow-up data for echocardiographic outcomes and longest available follow-up data for clinical outcomes. Results Ten trials with a total of 9,388 patients (BE-THV: 2,562; SE-THV 2,863; SAVR:3,963) were included. Follow-up ranged from 1–6 years. SE-THV demonstrated significantly larger effective orifice area, lower mean aortic valve gradient (AVG), and less increase in mean AVG at 5-years compared to BE-THV and SAVR (Figure 1). Structural valve deterioration (SVD) was less frequent in SE-THV compared to BE-THV and SAVR (HR 0.14, 95% CI 0.07–0.27; HR 0.34, 95% CI 0.24–0.47, respectively) (Figure 1). Total moderate-severe aortic regurgitation and re-intervention was more frequent in BE-THV (HR 4.21, 95% CI 2.40–7.39; HR 2.22, 95% CI 1.16–4.26, respectively) and SE-THV (HR 7.51, 95% CI 3.89–14.5; HR 2.86, 95% CI 1.59–5.13, respectively) compared to SAVR. Conclusion TAVR with SE-THV demonstrated favorable forward-flow hemodynamics and lowest risk of SVD compared to BE-THV and SAVR at mid-term. However, both THV systems suffer an increased risk of aortic regurgitation and re-intervention, and long-term data from newer generation valve is warranted. Funding Acknowledgement Type of funding sources: None.

Clinical impact of the repair technique for posterior mitral leaflet prolapse: Resect or respect?

Leaflet resection and chordal reconstruction are established repair techniques for posterior mitral valve (MV) prolapse. This study aimed to compare the clinical results of the resect and respect approaches, with a particular focus on MV hemodynamics. Overall, 291 patients who underwent elective MV repair for isolated posterior leaflet prolapse between 2012 and 2020 were enrolled. Patients who underwent leaflet resection alone were classified as the "resection" group (n = 166), while patients who underwent neochordal replacement with/without limited leaflet resection were classified as the "respect" group (n = 125). Early postoperative MV hemodynamics and midterm repair durability were compared between the groups. The annuloplasty ring size was significantly larger in the respectgroup than in the resection group (31.0 ± 2.1vs. 30.4 ± 2.0 mm, p = .028). The respectgroup showed significantly lower mean MV gradient (2.6 ± 1.1vs. 3.0 ± 1.4 mmHg, p = .03) and larger effective orifice area (EOA) (1.86 ± 0.48vs. 1.66 ± 0.47 cm2 , p < .001) than the resection group. Multivariable analysis identified the respect approach, younger age, female sex, larger ring size, and partial band as independent determinants of larger EOA. The rate of freedom from moderate or greater recurrent mitral regurgitation 5 years postoperatively was 90.9% in both groups. The respect approach allowed for a lower MV gradient and a larger EOA than the resection approach, which is possibly due to the capability of implanting a larger annuloplasty ring.

Impact of the Trifecta bioprosthetic valve in patients with low-flow severe aortic stenosis

Aortic stenosis (AS) is the most common valve disorder in advanced age. Previous reports have shown that low-flow status of the left ventricle is an independent predictor of cardiovascular mortality after surgery. The Trifecta bioprosthesis has recently shown favorable hemodynamic performance. This study aimed to evaluate the effect of the Trifecta bioprosthesis, which has a large effective orifice area, in patients with low-flow severe AS who have a poor prognosis. We retrospectively evaluated 94 consecutive patients with severe AS who underwent aortic valve replacement (AVR). Patients were divided into two groups according to the stroke volume index (SVI): low-flow (LF) group (SVI < 35 ml/m2, n = 22) and normal-flow (NF) group (SVI ≥ 35 ml/m2, n = 72). Patients’ characteristics and early and mid-term results were compared between the two groups. There were no differences in patients’ characteristics, except for systolic blood pressure (LF:NF = 120:138 mmHg, p < 0.01) and the rate of atrial fibrillation between the groups. A preoperative echocardiogram showed that the pressure gradient was higher in the NF group than in the LF group, but aortic valve area was similar. The Trifecta bioprosthesis size was similar in both groups. The operative outcomes were not different between the groups. Severe patient–prosthesis mismatch (PPM) (< 0.65 cm2/m2) was not observed in either of the groups. There were no significant differences in mid-term results between the two groups. The favorable hemodynamic performance of the Trifecta bioprosthesis appears to have the similar outcomes in the LF and NF groups. AVR with the Trifecta bioprosthesis should be considered for avoidance of PPM, particularly in AS patients with LV dysfunction.

Bovine pericardial versus porcine stented replacement mitral valves: early hemodynamic performance and clinical results of a randomized comparison of the Perimount and the Mosaic valves.

BackgroundTo compare the hemodynamic and clinical outcomes following mitral valve replacement with the Perimount valve with those of the Mosaic valve.MethodsA total of 145 consecutive patients with rheumatic heart valve disease who underwent single bioprosthetic mitral valve replacement were randomized to receive either the Perimount (n=72) valve or the Mosaic bioprosthesis (n=73). The mean age of patients was 72.1 years (range, 58–89 years) with a sex distribution of 55.2% female and 44.8% male. Patients underwent follow up transthoracic echocardiography at 3 months and 1 year postoperatively. We compared demographics, preoperative clinical data, operative data, hemodynamic profiles, and clinical outcomes.ResultsThe cross-clamp time was similar, with 50.7±15.3 minutes for the Perimount and 50.7±21.8 minutes for the Mosaic bioprosthesis. The total bypass time was also similar, with 91.3±25.7 minutes for the Perimount and 87.8±25.6 minutes for the Mosaic valve. The peak and mean pressure gradients were lower in the Perimount group for all valve sizes and the difference was statistically significant at 1 year. The effective orifice area (EOA) was slightly larger in the Perimount valve (1.98±0.21 vs. 1.89±0.71 cm2, P=0.538) postoperatively, but there was no significant difference at 1 year. There were no differences in preoperative or postoperative left atrium diameter (LAD), left ventricular diastolic diameter (LVDD), left ventricular systolic diameter (LVSD), left ventricular ejection fraction (LVEF), pulmonary artery pressure (PAP). The mortality and major complications rate were similar between the two groups.ConclusionsThe Perimount prostheses is superior to the Mosaic prostheses after mitral valve replacement, achieving statistically significant lower gradients and larger EOA when compared on the basis of manufacturer-labeled valve sizes. Both valves appear to provide satisfactory clinical results.

P107 Predictors of increased d-dimer level at follow-up period after transcatheter aortic valve implantation.Is oral anticoagulation therapy better?

Abstract Background Recently, there are some reports that hypo-attenuated leaflet thickening (HALT) following transcatheter aortic valve implantation (TAVI) is incidentally detected by multi-slice computed tomography. It is believed that valve thrombosis causes HALT, because oral anticoagulation therapy (OAC) is effective for HALT regression. Furthermore, it is reported that d-dimer level increases in patients with HALT, and might be a key biomarker to detect HALT. Purpose We sought to investigate the predictors related to increased d-dimer level at 6 months after follow-up TAVI. Methods We enrolled 124 consecutive patients who underwent successful TAVI between 2016 and 2018. Study patients were classified into two groups according to antithrombotic therapy resume (OAC therapy or anti-platelet therapy).We set the primary endpoint as the d-dimer levels at 6 months after TAVI. To evaluate the risks of the primary endpoint, we employed a multivariable linear regression model, setting the primary endpoint as an objective variable and patient and clinical backgrounds as explanatory variables. Furthermore, we set the secondary endpoint as one-year bleeding event. Results The median age of patients was 83 years old (quartile 80-87). Patients who had taken OAC at 6 months follow-up after TAVI were 29.8%. The median d-dimer level at 6 months after TAVI was 1.3 (1.0-2.2) µg/ml, and OAC group had statistically lower d-dimer level at 6 months follow-up than those in non-OAC group (p = 0.020). Uni-variable liner regression model demonstrated that increased d-dimer level at follow-up had significant relationship with large effective orifice area (EOA) (p = 0.002) and low left ventricular ejection fraction (LVEF) (p = 0.048) after TAVI. Furthermore, large EOA (p = 0.003) and OAC therapy (p = 0.027) were independently associated with increased d-dimer level in multivariate analysis. Kaplan-Meier estimates revealed that there were no significant difference regarding one-year bleeding event between OAC group and non-OAC group (long-rank p = 0.167). Conclusions This study suggests that large EOA after TAVI is associated with increased d-dimer levels at 6 months after TAVI, and OAC therapy might have a potential to decrease d-dimer level after TAVI without increase of bleeding events. Abstract P107 Figure: One-year bleeding event

Immediate Outcomes of Aortic Valve Neocuspidization with Glutaraldehyde-treated Autologous Pericardium: a Multicenter Study.

ObjectiveTo determine the feasibility of aortic valve neocuspidization (AVNeo) with glutaraldehyde-treated autologous pericardium.MethodsOne hundred and seventy (170) AVNeo (84 males/86 females) were performed from January 2017 through March 2019 in three centers. All the records were prospectively collected and retrospectively reviewed.ResultsMost of the patients were older than 60 years and over 95% were operated for aortic stenosis. Preoperatively, pressure gradients were 69.9±21.3 mmHg for patients with aortic stenosis, and the surgical annular diameter was 21.0±2.0 mm for all patients. Effective orifice area (EOA) and indexed EOA (iEOA) averaged 0.7±0.3 cm2 and 0.4±0.2 cm2/m2 for patients with aortic stenosis before surgery, respectively. There was no conversion to prosthetic aortic valve replacement. Eight patients needed reoperation for bleeding, but no patient needed reoperation due to early infective endocarditis. There were five in-hospital deaths due to noncardiac cause. Compared to preoperative echocardiographic measurements, postoperative peak pressure gradient decreased significantly (-58.7±1.7 mmHg; P<0.001) and reached 11.2±5.6 mmHg, and mean pressure gradient also decreased significantly (-36.8±1.1 mmHg; P<0.001) and reached 6.0±3.5 mmHg. Accordingly, EOA and iEOA increased significantly 2.0 cm2 and 1.0 cm2/m2 (both P<0.001) to reach 2.7±0.6 cm2 and 1.4±0.3 cm2/m2 after surgery, respectively, with minimal significant aortic regurgitation (0.6% > mild).ConclusionAVNeo is feasible and reproducible with good clinical results. Hemodynamically, AVNeo produces immediate postoperative low-pressure gradients, large EOA, and minimal regurgitation of the aortic valve. Further studies are necessary to evaluate mid- and long-term evolution.

Effect of postdilatation following balloon expandable transcatheter aortic valve implantation

Postdilatation after transcatheter heart valve (THV) implantation was associated with larger aortic valve areas in large-scale registries; however, the specific effects of postdilatation are poorly understood. Among a total of 224 consecutive patients who underwent transcatheter aortic valve replacement using SAPIEN 3, 121 patients (54.0%) underwent postdilatation (same contrast volume: N = 101, +1 ml: N = 17, +2 ml: N = 3). THV diameter was assessed (a) during, (b) after implantation, (c) during postdilatation, and (d) after postdilatation by quantitative fluoroscopy. In the overall patients (N = 224), acute recoil was observed from during implantation (23.0 ± 2.0 mm) to after implantation (22.5 ± 2.0 mm, p < .001) with an absolute recoil of 0.52 ± 0.25 mm. After postdilatation (N = 121), THV diameter significantly increased from 22.5 ± 2.0 mm to 22.9 ± 2.1 mm (p < .001), with smaller absolute recoil (0.39 ± 0.21 mm, p < .001). Compared with those who did not undergo postdilatation, patients who underwent postdilatation had larger postprocedural THV area assessed by multi-slice computed tomography (471.4 ± 78.1 mm2 vs. 447.5 ± 76.3 mm2 , p = .02) and larger effective orifice area (EOA) assessed by echocardiography throughout 1 year (at 30 day, 1.66 ± 0.33 cm2 vs. 1.45 ± 0.27 cm2 , p < .001; at 6 month, 1.66 ± 0.33 cm2 vs. 1.44 ± 0.29 cm2 , p < .001; at 1 year, 1.69 ± 0.38 cm2 vs. 1.47 ± 0.30 cm2 , p < .001). Postdilatation after implantation of the SAPIEN 3 valve produced a larger THV diameter with less acute recoil, followed by larger EOA throughout 1 year. Further studies are needed to evaluate the impact of postdilatation on long-term clinical outcomes.

Valve Hemodynamics Following Transcatheter or Surgical Aortic Valve Replacement in Patients With Small Aortic Annulus

This study aimed to compare the hemodynamic performance of transcatheter and surgical aortic valves in patients with severe symptomatic aortic stenosis and small aortic annulus (SAA) and to determine the valve hemodynamics according to transcatheter valve type. Consecutive surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) patients with SAA were case-matched (1:1) on the basis of sex, body surface area, aortic annulus diameter, and left ventricular ejection fraction. A total of 357 patients in each group constituted the final study population. A second match on the basis of aortic annulus diameter and valve/annulus calcium burden was performed within the TAVR group to compare the valve performance between balloon- (n = 52) and self-expanding (n = 52) transcatheter valve systems (BEV, SEV). The echocardiograms performed at hospital discharge were used for evaluating valve hemodynamics. The mean annulus diameter of the study population was 19.2 ± 0.3 mm. The TAVR group (vs SAVR) exhibited lower mean gradient (12 ± 7 mm Hg vs 15 ± 6 mm Hg, p <0.001), larger effective orifice area (1.46 ± 0.39 cm2 vs 1.25 ± 0.37 cm2, p <0.001) and a lower rate of severe prosthesis-patient mismatch (PPM) (14% vs 24%, p = 0.001). Moderate-severe AR was present in 2.5% of the TAVR recipients versus none patient in the SAVR group. There were no differences in valve hemodynamics between balloon-expanding transcatheter valve system and self-expanding transcatheter valve system, and similar rates of severe PPM were observed in both groups (p = 0.488). In conclusion, TAVR presented superior valve hemodynamics and lower incidence of severe PPM compared with SAVR in SAA patients. Similar valve performance results were observed between transcatheter valve types.

P2270Clinical characteristics and outcomes after TAVI in patients reclassified to moderate aortic stenosis by integration of multimodality imaging and pressure recovery

Abstract Background Accurate assessment of aortic stenosis (AS) severity is critical for the correct management of patients. This has become particularly important because the introduction of transcatheter aortic valve implantation (TAVI) has markedly increased the number of patients eligible for aortic valve replacement Aims To assess whether reclassification of aortic stenosis (AS) grading by integration of fusion imaging using data from transthoracic echocardiography (TTE) and multidetector computed tomography (MDCT) under consideration of the energy loss index (ELI) predicts outcome in patients undergoing transcatheter aortic valve implantation (TAVI). Methods 197 consecutive patients with symptomatic severe AS undergoing TAVI at our University Heart Center were included in this study. AS severity was determined according to current guidelines. Results Left ventricular outflow tract (LVOT) area derived from TTE was smaller than the planimetric area in MDCT due the ovoid shape of the LVOT (3.4±0.12 cm2 vs. 4.5±0.23 cm2; p&lt;0.01). The sinotubular junction (ST-junction) diameter measured in TTE was similar to maximal, minimal, and mean diameters determined by MDCT. The sphericity index confirmed an almost circular anatomy of ST-junction, and its area derived from TTE was similar to the planimetric area in MDCT. Fusion aortic valve area index (fusion AVAi) assessed by inserting MDCT derived planimetric LVOT area in the continuity equation was significantly higher in all patients compared to conventional AVAi. 62 patients were reclassified from severe to moderate AS because fusion AVAi was &gt;0.6 cm2/m2. ELI was calculated for conventional AVAi and fusion AVAi each with ST-junction area determined by both TTE and MDCT. Calculating ELI with fusion AVAi resulted in significantly larger effective orifice area, with values &gt;0.6 cm2/m2 in 83 patients (ST-junction area from echo) and 85 patients (ST-junction area from MDCT). Similarly, calculating ELI with conventional AVAi resulted in significantly larger effective orifice area as compared to AVAi alone. Reclassified patients had lower mean transvalvular pressure gradients, lower myocardial mass, less symptoms according to NYHA classification, and lower proBNP levels at baseline. While both groups exhibited improvement of functional status at 1 year of follow-up, the survival rate at 3 years after TAVI was higher in patients reclassified to moderate AS (81% versus 66%; p=0.02). Conclusion Integration of TTE and MDCT derived values for calculation of ELI reclassifies the severity of AS in 43% of patients initially diagnosed with severe AS.Although reclassified patients display less advanced valve disease at baseline, TAVI results in functional improvement in all patients. Furthermore, patients reclassified to moderate AS exhibit higher survival rates at 3 years after aortic valve replacement.

Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients

BackgroundTranscatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients.MethodsWe performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods.ResultsOf the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients’ mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, −1.4 percentage points; 95% Bayesian credible interval for difference, −4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm2 vs. 2.0 cm2).ConclusionsIn patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.)

An Echocardiographic Comparison of Sutureless and Conventional Aortic Valve Replacement: a Matched Case-Control Study

Background Patients at a high operative risk for conventional aortic valve replacement (AVR) may be offered sutureless valve implantation. Sutureless valves resemble conventional valves but incorporate an anchoring mechanism without using annular sutures. Methods Pre-operative and six month post-operative echocardiography data from our first year, single centre experience of sutureless valves was compared to conventional aortic valve replacements in patients matched for operative risk. Left ventricular ejection fraction, mean and peak AV gradients and inter-ventricular septal thickness, effective orifice area (EOA) and indexed effective orifice area (iEOA) were measured. Results The drops in mean and peak pre- to post-operative gradients were greater in the sutureless group, p=0.039 and p=0.001 respectively. Post-operative EOA was 1.69 cm2 and 1.26 cm2 (p=0.001) in the sutureless and conventional groups. Similarly iEOA was 0.93 cm2 and 0.74 cm2 (p=0.001) in the sutureless and conventional groups. There was also a reduction in patient prosthesis mismatch (PPM) in the sutureless group as compared to the conventional group (Chi square test p=0.026). Post-operative inter-ventricular septal thickness was 1.13 cm2 in the sutureless group and 1.35 cm2 in the conventional group (p=0.011). Conclusions Use of sutureless valves with a stent framework resulted in larger EOA and iEOA and a diminution in PPM; and lead to a statistically significant faster regression in inter-ventricular septal thickness that is a measure of left ventricular mass. The rate and extent of regression in left ventricular hypertrophy after AVR is important since it determines long-term survival including mortality, heart failure and decreased admission rates.

Accuracy of the Single Cycle Length Method for Calculation of Aortic Effective Orifice Area in Irregular Heart Rhythms

In irregular heart rhythms, echocardiographic calculation of aortic effective orifice area (EOA) requires averaging measurements from multiple cardiac cycles. Whether a single cycle length method can be used to calculate aortic EOA in aortic stenosis with nonsinus rhythms is not known. Transthoracic echocardiograms of 100 patients with aortic stenosis and either atrial fibrillation (AF) or frequent ectopy (FE) were retrospectively reviewed. The aortic valve velocity time integral (VTIAV) and the left ventricular outflow tract VTI (VTILVOT) were measured by two methods: the standard method (averaging multiple beats) and the single cycle length method. The latter matches the R-R intervals for VTIAV and VTILVOT. Stroke volume, EOA, and Doppler velocity index were calculated by both methods in all patients. The single cycle length method was used for short and long R-R cycles in AF and for postectopic beats (long R-R cycles) in FE. In AF, long R-R cycles resulted in larger stroke volumes (73±21 vs 63±18mL; P≤.0001) but no difference in EOA (0.84±0.27 vs 0.82±0.27cm2; P=.11), whereas short R-R cycles resulted in smaller stroke volumes (55±18 vs 63±18mL, P≤.0001) but a larger EOA (0.86±0.28 vs 0.82±0.27cm2; P=.01). In FE, the postectopic beat led to larger stroke volumes (96.1±28 vs 78±23mL; P<.0001) and a larger EOA (0.99±0.32 vs 0.94±0.32cm2; P=.0006) and Doppler velocity index (0.24±0.07 vs 0.23±0.07; P<.001). In AF patients, the single, long cycle length method of calculating EOA can be used instead of averaging multiple cardiac cycles. The single cycle length method used on a postextrasystolic beat results in a larger EOA than a normal sinus beat and may have utility in clinical decision-making.

OUTCOMES OF STENTLESS BIOPROSTHETIC AORTIC VALVES: THE ALBERTA EXPERIENCE

Stentless aortic bioprostheses have demonstrated hemodynamic benefits including laminar flow and larger effective orifice area. However, data on the long-term performance of this valve design is limited relative to conventional stented bioprostheses. As well, many stentless valves were implanted via full-root replacement, potentially making reoperation more technically demanding and higher risk. Alberta’s two cardiac centres have one of the largest experiences with stentless valves in North America. The objective of this study was to compare stentless and stented bioprostheses to assess long-term outcomes, including results of reoperative surgery. Two large prospectively maintained databases, including the province-wide APPROACH database, were used to create a retrospective consecutive cohort. Patients undergoing bioprosthetic aortic valve replacement (AVR) from January 2002 to March 2014 were included. All operations were performed at the Foothills Medical Centre (Calgary) or the University of Alberta Hospital (Edmonton). Patient characteristics, surgical details and clinical outcomes were compared between stentless and stented valve cohorts. During the timeframe, 3959 Albertans underwent AVR with either stentless (n=1238) or stented (n=2721) bioprotheses. The 2 cohorts were similar overall, though patients in the stentless group were younger (67.0±12.5 vs. 70.8 years; p<0.0001), and had higher incidence of COPD and dyslipidemia. The majority of stentless valves were Medtronic Freestyle porcine prostheses (n=992; 80.1%). Over the 12-year period, there was no difference in survival between the groups. Table 1 outlines reoperative outcomes. During a mean follow-up of 7.9±2.6 vs 5.3±2.4 years (stentless vs stented), there was a similar rate of AVR-related reoperation in both groups (4.3% vs. 8.6%, stentless vs. stented; p=0.32). Both reoperative cohorts demonstrated similar crossclamp times and cardiopulmonary bypass times. There was no difference in perioperative mortality at reoperation (7.6 vs 6.4%, stentless vs. stented; p=0.22). Reoperation in both groups were due to multiple reasons, but most common was structural valve deterioration (Figure 1). This study presents the largest reported cohort of sutureless valve patients. Outcomes suggest no significant difference in survival or rate or reoperation between stented and stentless valves over a 12-year follow-up period. Furthermore, reoperation in patients with stentless valves, though thought to be accompanied with higher technical difficulty and risk, does not demonstrate increases in crossclamp times, cardiopulmonary bypass times, perioperative mortality or all cause mortality. In the future, we hope to both extend the study period to determine differences in incidence of structural valve deterioration together with mechanism of failure.View Large Image Figure ViewerDownload Hi-res image Download (PPT)