Evolut PRO Research Articles

Prospective evaluation of transcatheter aortic valve implantation (TAVI) with coronary alignment and impact on coronary access

Abstract Introduction Transcatheter aortic valve implantation (TAVI) with optimised coronary alignment aims to reduce coronary-commissural overlap (CCO) to facilitate future coronary intervention and reduce the risk of coronary obstruction after re-do TAVI, however, in-vivo data are lacking. Aims To determine the feasibility of TAVI with coronary alignment assessed by post-TAVI CT. Secondary endpoints included the incidence of adverse anatomical features which could impede coronary access (severe CCO and ostia below valve skirt) and their association with coronary engagement during invasive angiography. Methods 30 patients underwent TAVI with optimised coronary alignment with either ACURATE neo2 or Evolut Pro+ and invasive coronary angiography and cardiac CT performed after valve deployment. Results 15 patients received ACURATE neo2 (50%) and 26 patients (86.7%) underwent CT after TAVI. The mean inter-coronary angle was 140 (19.5)° and the median observed angular deviation from perfect alignment (0°) was 0.8° (IQR -4.5 to +10) ° with perfect alignment (±15°) observed in 21/26 cases (80.8%) and ≤mild misalignment (±30°) in 24/26 of cases (92.3%). The remaining two cases had moderate misalignment (30-45°) with no cases of severe misalignment. The angle between the coronary ostia and the nearest TAVI commissure was 46 (40 - 57) ° for the RCA and 50.5 (43 - 54) ° for the LCA which did not differ significantly from the native situation (both p>0.2), with 1 (3.8%) case of severe overlap. 46/55 (83.6%) coronary engagements were selective, 7/55 (12.7%) semi-selective and 2/55 (3.6%) unable to intubate. Non-selective engagement/unable to engage affected the RCA more than the LCA (6/27 [22.2%] vs. 3/28 [10.7%]) and was three-fold more common with the Evolut (7/29 [24.1%]) than the Acurate (2/26 [7.7%]. Coronary>commissural angle in those with unselective engagement was 43° (IQR 37 to 51°). Conclusions TAVI with optimised coronary alignment is technically feasible, safe and reduces coronary-commissural overlap which is important for future re-do TAVI procedures. Difficult coronary access was encountered more frequently following Evolut Pro+ and when engaging the RCA, but was unrelated to angular distance to nearest commissure.

Initial Findings Concerning the Latest Self-Expandable Evolut FX Valve: A Report Using OCEAN-TAVI Registry Data

Data concerning the clinical effect of the latest-generation self-expandable transcatheter heart valve (Evolut FX) remain limited. We aimed to assess the in-hospital outcomes of 3 bioprosthetic valves (Evolut EPO, PRO+, and FX). We analyzed data from a Japanese multicenter registry involving 634 consecutive patients who underwent transcatheter aortic valve replacement with Evolut FX up until October 2023. Patients who underwent transcatheter aortic valve replacement with Evolut EPO between 2018 and 2020 (n = 1,128), and those with Evolut EPO+ between 2020 and 2023 (n = 1,696) served as the control groups. The exclusion criteria comprised patients on dialysis with a history of infective endocarditis or with insufficient data. Unmatched comparisons among the 3 valves were conducted, followed by a propensity score-matched comparison between Evolut EPO+ and FX. In the unmatched cohort, among the Evolut EPO, PRO+, and FX groups, all vascular complications (7.8% vs 5.2% vs 4.5%, respectively, p <0.01) and new pacemaker implantation rates (11.2% vs 6.1% vs 7.7%, respectively, p <0.01) differed significantly. In the propensity score-matched analysis, the rate of all bleeding events was significantly higher in the Evolut EPO+ group (11.0%) than in the FX group (7.0%) (p = 0.02), whereas all vascular complications (4.6% vs 4.6%, respectively, p = 1.00) and new pacemaker implantation (5.9% vs 7.6%, respectively, p = 0.28) rates were comparable. The incidence of stroke in the FX group was approximately half that of the EP+ group (3.7% vs 1.9%, p = 0.095), without statistical significance. In conclusion, compared with the Evolut EPO+, Evolut FX was associated with a lower incidence of in-hospital bleeding complications and may reduce the incidence of in-hospital stroke.

Evolut PRO successfully deployed above the annulus plane for type 2 bicuspid aortic valve.

Evolut PRO successfully deployed above the annulus plane for type 2 bicuspid aortic valve.

Comparison of Two Generations of Self-Expandable Transcatheter Heart Valves in Nine Surgical Valves: An In Vitro Study.

(1) Background: This study aimed to analyse the hydrodynamic performance of two generations of self-expanding transcatheter heart valves (THV) as a valve-in-valve (ViV) in different surgical aortic valve (SAV) models under standardised conditions. The nitinol-based Evolut R valve is frequently used in ViV procedures. It is unclear whether its successor, the Evolut PRO, is superior in ViV procedures, particularly considering the previously implanted SAV model. (2) Methods: EvolutTM R 26 mm and EvolutTM PRO 26 mm prostheses were implanted in nine 21 mm labelled size SAV models (Hancock® II, Mosaic® UltraTM, EpicTM Supra, TrifectaTM GT, Perimount®, Perimount® Magna Ease, AvalusTM, IntuityTM, Freestyle®) to analyse their hydrodynamic performance under defined circulatory conditions in a pulse duplicator. (3) Results: Both THVs presented with the lowest effective orifice area (EOA) and highest mean pressure gradient (MPG) inside Hancock® II, whereas THVs in Intuity showed the highest EOA and lowest MPG. Evolut R and Evolut PRO showed significant hydrodynamic differences depending on the SAV. Both THVs performed similarly in porcine valves. Although the Evolut R performed better than Evolut PRO in stented bovine SAVs, the Evolut PRO was superior inside the Intuity. Further, the SAV model design markedly influenced the TAV's geometric orifice area and pin-wheeling index. (4) Conclusions: These findings show that the Evolut R and Evolut PRO perform differently depending on the previously implanted SAV model. THV selection for treatment of a specific SAV model should consider these results.

Coronary Access and PCI after Transcatheter Aortic Valve Replacement With Different Self-Expanding Platforms in Failed Surgical Valves

BackgroundCoronary access (CA) and percutaneous coronary intervention (PCI) might be challenging after valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) with supra-annular self-expanding valves (SS-TAVs) in surgical aortic valves (SAVs). Our study aim was to compare feasibility, predictors, and techniques of CA and PCI following ViV-TAVR with ACURATE neo2 (Boston Scientific, Marlborough, MA) and Evolut PRO+ (Medtronic, Minneapolis, MN). MethodsFifteen computed tomography (CT)-based patient-specific aortic models were 3-dimensionally (3D) printed and implanted with specific SAVs and with the 2 SS-TAVs with commissural alignment. Two operators attempted CA (n = 120) and PCI (n = 120) of each coronary artery in a pulsatile-flow-simulator, under real catheterization laboratory conditions. The primary endpoints were the rate of successful CA and PCI. Outcomes with different SS-TAVs were directly compared. An internally mounted borescope camera was used to assess procedures. CT of the models was obtained. ResultsACURATE neo2 showed significantly higher rates of successful CA (96.7% vs 75%, P = 0.001) and PCI (98.3% vs 85%, P = 0.008) and was associated with a shorter procedural time compared with Evolut PRO+. Independent predictors of unsuccessful CA and PCI were smaller SAV size and Evolut PRO+. The advantage of ACURATE neo2 was mediated by a larger valve-to-anatomy distance at the top of the leaflet plane (11.3 mm vs 4.8 mm), facilitating more often an external cannulation approach for both CA (36.7% vs 15%, P < 0.001) and PCI (36.7% vs 21.7%, P = 0.013). ConclusionsThe rate of successful CA and PCI following ViV-TAVR was higher with ACURATE neo2 compared with Evolut PRO+. The differences in SS-TAVs design affected the cannulation approach and subsequent procedural outcomes.

Leaflet stresses during crimping simulations of a CoreValve Evolut Pro model using a compression loading system

Background: Transcatheter aortic valve implantation is experiencing continued growth as an option for the treatment of aortic stenosis. With larger numbers of procedures being performed on lower risk and younger patients, there is increased scrutiny on valve durability. Leaflet stresses and potential damage have a significant role to play in this regard. Predictions of leaflet stresses have so far focused on either fluid-structure interaction simulations of blood flow through the prosthesis or, crimping simulations using a cylindrical surface. However, in reality, when a compression loading system (CLS) is used in the crimping of self-expanding valves, this could result in different stresses in the valve leaflets relative to those that might occur in crimping with a cylindrical surface.Method: A full model of a CoreValve Evolut Pro (Medtronic, Minneapolis, MN, USA) device was developed, comprising the frame, skirt and leaflets along with a representative model for the CLS as used in clinical practice. The full device was crimped to a final diameter of 18 Fr using the CLS model and the distribution and intensity of leaflet stresses was assessed. A similar assessment of leaflet stresses was also performed for crimping using radial displacement of a cylindrical surface. Comparison of the predicted leaflet stresses between the two models was undertaken, alongside a comparison of the stresses produced when dynamically loading the leaflets after deployment of the valve.Results: Both the CLS and cylinder crimping methods produced higher average and peak stresses on the leaflets compared to those produced during leaflet loading. The peak von Mises stresses for CLS crimping, cylinder crimping, and leaflet loading were 3.42 MPa, 3.92 MPa, and 1.77 MPa respectively. The leaflet folding pattern between the CLS crimping and cylinder crimping methods were different, resulting in different high stress locations on the leaflets. However, the average stress magnitude at the final crimped stage between the two crimping methods were similar.Conclusions: High fidelity simulations of crimping and expansion of a complete CoreValve Evolut Pro model using a compression loading system model have been performed, wherein the results showed that peak leaflet stresses in the crimped valve were approximately twice as high as the maximum leaflet stresses under dynamic loading. This finding has significant implications for device durability due to the high stresses and possible damage they might inflict on the leaflets. It was also found that crimping using a compression loading system versus a simpler cylindrical surface produced different folding patterns and stress distributions. However, for future studies that are not concerned with accurately capturing the leaflet folding patterns and stresses throughout the crimping process, crimping via a cylindrical surface can be used instead of simulating the full CLS model.

Impact of leaflet splitting on coronary access after redo-TAVI for degenerated supra-annular self-expanding platforms.

Coronary access (CA) is a major concern in redo-transcatheter aortic valve implantation (TAVI) for failing supra-annular self-expanding transcatheter aortic valves (TAVs). This ex vivo study evaluated the benefit of leaflet splitting (LS) on subsequent CA after redo-TAVI in anatomies deemed at high risk of unfeasible CA. Ex vivo, patient-specific models were printed three-dimensionally. Index TAVI was performed using ACURATE neo2 or Evolut PRO (TAV-1) at the standard implant depth and with different degrees of commissural misalignment (CMA). Redo-TAVI was performed using the balloon-expandable SAPIEN 3 Ultra (TAV-2) at different implant depths with commissural alignment. Selective CA was attempted for each configuration before and after LS in a pulsatile flow simulator. The leaflet splay area was assessed on the bench. In matched comparisons of 128 coronary cannulations across 64 redo-TAVI configurations, the overall feasibility of CA significantly increased after LS (60.9% vs 18.7%; p<0.001). The effect of LS varied according to the sinotubular junction height, TAV-1 design, TAV-1 CMA, and TAV-2 implant depth, given TAV-2 alignment. LS enabled CA for up to CMA 45° with the ACURATE neo2 TAV-1 and up to CMA 30° with the Evolut PRO TAV-1. The combination of LS and a low TAV-2 implant provided the highest feasibility of CA after redo-TAVI. The leaflet splay area ranged from 25.60 mm2 to 37.86 mm2 depending on the TAV-1 platform and TAV-2 implant depth. In high-risk anatomies, LS significantly improves CA feasibility after redo-TAVI for degenerated supra-annular self-expanding platforms. Decisions on redo-TAVI feasibility should be carefully individualised, taking into account the expected benefit of LS on CA for each scenario.

Conduction disorders following transcatheter aortic valve replacement using acurate Neo2 transcatheter heart valve: A propensity matched analysis

BackgroundThe ACURATE neo2 transcatheter aortic valve was developed to improve paravalvular leak (PVL) rates while maintaining low rates of conduction disturbances and permanent pacemaker implantation (PPMI) seen with its predecessor. We aimed to compare conduction disturbances rates of transcatheter aortic valve replacement (TAVR) using ACURATE Neo2 with other commonly used valves. MethodsA retrospective analysis of the Israeli TAVR registry between the years 2014–2023 was performed to compare conduction disturbances and PVL rates, and procedural outcomes, among patients treated with ACURATE neo2, Edwards Sapien 3 (S3), and Evolut PRO valves. Propensity score matching was performed to compare groups with similar characteristics. ResultsFollowing exclusion of patients with non-femoral access, unknown valve type, older-generation valves, and less commonly used valves or (n = 4387), our analysis included 3208 patients undergoing TAVR using ACURATE neo2, Edwards S3, and Evolut PRO valves. Propensity matched groups comprised 169 patients each. Rates of any conduction disturbances [left bundle branch block (LBBB), atrioventricular block, or PPMI] were lower in the ACURATE neo2 group compared to both other valves [15.8 %, S3–37.5 % (p < 0.001), Evolut PRO-27.5 % (p = 0.02)] as were LBBB rates [9.0 %, S3–31.3 % (p < 0.001); Evolut PRO-20.1 % (p = 0.01). Atrioventricular block and PPMI rates were lower without statistical significance, as were rates of above-moderate PVL. ConclusionsIn this analysis, TAVR using ACURATE neo2 was associated with a lower composite rate of conduction disturbances in comparison to the Evolut PRO and Edwards S3 valves, mainly due to lower left bundle branch block rates, with non-significantly lower rates of PPMI and PVL.

Decreasing pacemaker implantation rates with Evolut supra-annular transcatheter aortic valves in a large real-world registry

BackgroundPermanent pacemaker implantation (PPI) rates following transcatheter aortic valve replacement (TAVR) remain a concern. We assessed the PPI rates over time in patients implanted with an Evolut supra-annular, self-expanding transcatheter valve from the US STS/ACC TVT Registry. MethodsPatients who underwent TAVR with an Evolut R, Evolut PRO or Evolut PRO+ valve between July 2018 (Q3) and June 2021 (Q2) were included. PPI rates were reported by calendar quarter. In-hospital PPI rates were reported as proportions and 30-day rates as Kaplan-Meier estimates. A Cox regression model was used to determine potential predictors of a new PPI within 30 days of the TAVR procedure. ResultsFrom July 2018 to June 2021, 54,014 TAVR procedures were performed using Evolut valves. Mean age was 79.3 ± 8.8 years and 49.2 % were male. The 30-day PPI rate was 16.6 % in 2018 (Q3) and 10.8 % in 2021 (Q2, 34.9 % decrease, p < 0.001 for trend across all quarters). The in-hospital PPI rate decreased by 40.1 %; from 14.7 % in 2018 (Q3) to 8.8 % in 2021 (Q2) (p < 0.001 for trend across all quarters). Significant predictors of a new PPI within 30 days included a baseline conduction defect, history of atrial fibrillation, home oxygen, and diabetes mellitus. ConclusionFrom 2018 to 2021, TAVR with an Evolut transcatheter heart valve in over 50,000 patients showed a significant decreasing trend in the rates of in-hospital and 30-day PPI, representing the lowest rate of PPI in any large real-world registry of Evolut. During the same evaluated period, high device success and shorter length of stay was also observed.

Prosthesis Infolding Incidence and Short-Term Outcomes in Transcatheter Aortic Valve Implantation Using Evolut Self-Expandable Device: A Multicenter Study

Transcatheter aortic valve implantation (TAVI) is an established treatment strategy in aortic valve disease. Infolding, as a nonuniform expansion of the prosthesis leading to introflection of part of the device circumference, is a complication specific to self-expandable prostheses. The aim of the study is to determine incidence, predictors, treatment strategy, and outcomes of infolding during Medtronic Evolut TAVI (Minneapolis, MN, US). Between January 2018 and March 2022, all patients treated with Evolut TAVI were included in a multicenter observational retrospective study. According to the occurrence of infolding, the enrolled cohort was divided into 2 groups; periprocedural characteristics and 30-day outcomes were compared. A total of 1,470 patients were included; 23 infolding cases (1.6%) were detected. Preprocedural imaging showed larger aortic anatomy and greater calcium burden in the infolding group. Infolding occurred mostly with Evolut Pro+ and size 34 mm and was diagnosed before full prosthesis release in 78.3%. The rate of moderate-to-severe paravalvular regurgitation was higher in the infolding group (21.7% vs 1.9%, p <0.001). Short-term follow-up showed greater all-cause and cardiovascular mortality (respectively, 4.3% vs 0.7% and 4.3% vs 0.6%, p <0.05) and higher rate of pacemaker implantation (33.3% vs 15.7%, p = 0.042) in case of infolding. High right cusp calcium score and resheathing maneuvers were independent predictors of infolding. In conclusion, prosthesis infolding is a TAVI complication burdened by worse cardiovascular outcomes. Prompt intraprocedural infolding diagnosis is pivotal, especially in case of great native valve calcium burden and resheathing maneuvers, to safely overcome this complication by prosthesis recapture or postdilation.

Hemodynamic performance of self-expandable transcatheter aortic valve replacement systems during valve deployment.

Little is known about valve hemodynamic performance during the Evolut and Neo deployment course. We aimed to evaluate transvalvular mean and peak-to-peak gradients over several intraprocedural timepoints during TAVR with Evolut PRO+ (Medtronic) and Neo (Boston Scientific) systems. This was single-center pilot sub-study from the SavvyWire EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI) trial. Participants received either the Evolut PRO+ or Neo for native valve severe aortic stenosis and the SavvyWire (OpSens Medical) was used for device delivery, pacing, and continuous left ventricular and aortic pressure measurements. For the Evolut, evaluation was done for baseline, two-thirds of valve deployment (still recapturable), 90% of valve deployment (no longer recapturable), and post-deployment hemodynamics. For the Neo, analysis was done at baseline, after the first step (top-crown deployment), and at final status. Nineteen patients were included (Evolut = 15; Neo = 4). There were no statistically significant changes in peak-to-peak gradients (44 mm Hg [IQR:33-69] vs 43 mm Hg [IQR:26-62], P = .41) between baseline and two-thirds of valve deployment in the Evolut patients. There was a significant decrease in mean (40 mm Hg [IQR:32-54] vs 14 mm Hg [IQR:10-18], P less than .001) and peak-to-peak (43 mmHg [IQRS:26-62] vs 9 mm Hg [IQR:8-13], P less than .001) transvalvular gradients between two-thirds and 90% of valve deployment for Evolut. Neo patients exhibited a decrease in transvalvular gradients after top-crown deployment (42.5 mm Hg baseline vs 13 mm Hg). Transvalvular gradients did not vary between the point of "no-recapture" compared to baseline values in patients receiving the Evolut, whereas a significant reduction in transvalvular gradients was observed when the valve was deployed at 90% and fully deployed. The Neo valve was slightly obstructive after the first step of deployment.

Sex-Related Outcomes of Transcatheter Aortic Valve Implantation With Self-Expanding or Balloon-Expandable Valves: Insights from the OPERA-TAVI Registry

Evidence regarding gender-related differences in response to transcatheter aortic valve implantation according to the valve type is lacking. This study aimed to evaluate the impact of gender on the treatment effect of Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices on clinical outcomes. The Comparative Analysis of Evolut PRO vs SAPIEN 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation (OPERA-TAVI) is a multicenter, multinational registry including patients who underwent the latest-iteration PRO or ULTRA implantation. Overall, 1,174 of 1,897 patients were matched based on valve type and compared according to gender, whereas 470 men and 630 women were matched and compared according to valve type. The 30-day and 1-year outcomes were evaluated. In the PRO and ULTRA groups, men had a higher co-morbidity burden, whereas women had smaller aortic root. The 30-day (device success [DS], early safety outcome, permanent pacemaker implantation, patient-prosthesis mismatch, paravalvular regurgitation, bleedings, vascular complications, and all-cause death) and 1-year outcomes (all-cause death, stroke, and heart failure hospitalization) did not differ according to gender in both valve groups. However, the male gender decreased the likelihood of 30-day DS with ULTRA versus PRO (p for interaction = 0.047). A higher risk of 30-day permanent pacemaker implantation and 1-year stroke and a lower risk of patient-prosthesis mismatch was observed in PRO versus ULTRA, regardless of gender. In conclusion, gender did not modify the treatment effect of PRO versus ULTRA on clinical outcomes, except for 30-day DS, which was decreased in men (vs women) who received ULTRA (vs PRO).

Transcatheter aortic valve implantation using coplanar and cuspal overlap techniques in Indian patients

IntroductionTranscatheter Aortic Valve Implantation (TAVI) techniques gradually evolved since 2002 and have undergone various refinements. Achieving optimal implantation depth has become crucial for good long term outcome. High implantation decreases the likelihood of conduction disturbances. Conventionally TAVI valve is positioned in a tricusp coplanar (CON) fluoroscopic projection however it does not ensure a optimal implantation. In an attempt to attain higher implantation(3 mm) and decrease rate of permanent pacemaker, cuspal overlap technique (COT) view has been developed. There is scarcity of Indian literature comparing TAVI deployment using coplanar and cuspal overlap techniques. MethodsWe included 111 patients who underwent TAVR with a self-expanding Core Valve Evolut R (Medtronic, Minneapolis, Minnesota), between January 2017 to September 2022 at our centre.Transcatheter Heart Valves (THV) were implanted using the traditional coplanar in 55 patients, while in 56 patients valves were implanted using the COT. ResultsBaseline characteristics including electrocardiographic findings were comparable in both groups. In all patients Evolut R or Evolut PRO valves were used. Procedure was done in conscious sedation in 90.9 % of patients in CON and 96.4 % in COT group. Predilatation and postdilatation was used in 38.8 % vs 33.9 % and 27 % vs 32 % in CON and COT groups respectively. 90 day PPI rate was less in COT group (7.3 % CON vs 3.5 % COP). Majority of patients who received permanent pacemaker implantation (PPI) had baseline ECG abnormality (RBBB in 50 %, LBBB in 16 %, Grade 1 AV block 16 %). Mean time of post procedure PPI was 5.6 days in COT group and 7.3 days in CON group. New onset LBBB was also less in COT group (21 % CON vs 12.5 % COT).There were 3.6 % intraprocedural deaths in CON group and 1.8 % in COT group. Depth of deployed valve was 4.8 ± 2.34 mm in COT and 6.6 ± 2.11 mm in CON group. Valve deployment time was more in COT group(10.40 CON vs 14.34 min COT). Average valve recapture rate was 2.58 in COP and 2.11 in CON. Stroke rate was more in COT group(3.6 % CON vs 7.14 % COT). Pericardial effusions were also more in COT group. All cause mortality at 3 months was 10.9 % in CON group and 5.3 % in COT. ConclusionIn this study we achieved lower rates of PPI and new onset LBBB using COT technique in Indian patients using self-expandable prostheses. However valve deployment time, stroke rate and pericardial effusion were seen more in COT group. All cause mortality was low in cuspal overlap technique.

Comparison of paravalvular leak and 1-year survival after transcatheter aortic valve replacement with SAPIEN 3 versus EVOLUT PRO valves

Comparison of paravalvular leak and 1-year survival after transcatheter aortic valve replacement with SAPIEN 3 versus EVOLUT PRO valves

Leaflet Mechanical Stress in Different Designs and Generations of Transcatheter Aortic Valves: An in Vitro Study

BackgroundIt is unknown whether bioprostheses used for transcatheter aortic valve implantation will have similar long-term durability as those used for surgical aortic valve replacement. Repetitive mechanical stress applied to the valve leaflets, particularly during diastole, is the main determinant of structural valve deterioration. Leaflet mechanical stress cannot be measured in vivo. The objective of this in vitro/in silico study was thus to compare the magnitude and regional distribution of leaflet mechanical stress in old vs new generations of self-expanding (SE) vs balloon expandable (BE) transcatheter heart valves (THVs). MethodsA double activation simulator was used for in vitro testing of two generations of SE THV (Medtronic CoreValve 26 mm and EVOLUT PRO 26 mm) and two generations of BE THV (Edwards SAPIEN 23 mm vs SAPIEN-3 23 mm). These THVs were implanted within a 21-mm aortic annulus. A noncontact system based on stereophotogammetry and digital image correlation with high spatial and temporal resolution (2000 img/sec) was used to visualize the valve leaflet motion and perform the three-dimensional analysis. A finite element model of the valve was developed, and the leaflet deformation obtained from the digital image correlation analysis was applied to the finite element model to calculate local leaflet mechanical stress during diastole. ResultsThe maximum von Mises leaflet stress was higher in early vs new THV generation (p < 0.05) and in BE vs SE THV (p < 0.05): early generation BE: 2.48 vs SE: 1.40 MPa; new generation BE: 1.68 vs SE: 1.07 MPa. For both types of THV, the highest values of leaflet stress were primarily observed in the upper leaflet edge near the commissures and to a lesser extent in the mid-portion of the leaflet body, which is the area where structural leaflet deterioration most often occurs in vivo. ConclusionsThe results of this in vitro/in silico study suggest that: i) Newer generations of THVs have ∼30% lower leaflet mechanical stress than the early generations; ii) For a given generation, SE THVs have lower leaflet mechanical stress than BE THVs. Further studies are needed to determine if these differences between new vs early THV generations and between SE vs BE THVs will translate into significant differences in long-term valve durability in vivo.

Impact of sex on Transcatheter aortic valve replacement outcomes: Results of a single-center study

BackgroundEarly studies on transcatheter aortic valve replacement (TAVR) outcomes showed that female sex was associated with better survival. With increased use of new-generation valves, the impact of sex on contemporary TAVR outcomes is less well known. MethodsRetrospective analysis using institutional National Cardiovascular Data Registry STS/ACC TVT data was performed on all patients undergoing TAVR at Yale New Haven Hospital from July 2012 to August 2019. New-generation valves were Evolut PRO, Evolut R, and SAPIEN 3. Old-generation valves were CoreValve, SAPIEN, and SAPIEN XT. Log-rank test and Kaplan-Meier curves were used to compare sex differences in survival up to 1 year after TAVR. Cox modeling was used to adjust for baseline and procedural characteristic differences. Results927 consecutive patients (41.4% women) underwent TAVR. Women were older (82.8 vs 80.6 years old; p < 0.001) with higher STS mortality scores compared with men (7.6% vs 6.4%; p < 0.001) despite lower prevalence of cardiovascular comorbidities including coronary artery disease, peripheral artery disease, and smoking. Most cases used transfemoral access (90.5%) and new-generation devices (72.3%). Women received smaller valves compared with men (20–26 mm: 78.0% vs 32.9%; 29–34 mm: 22.1% vs 67.1%; overall p < 0.0001). There were no statistically significant differences between sexes in both unadjusted and adjusted 1-year mortality. ConclusionOur data show no significant difference in 1-year survival between sexes using primarily new generation valves. Further studies should reassess the impact of sex on TAVR outcomes and whether newer technologies like new valve design and sizes, and CT imaging may have eliminated sex-based disparities.

Recurrent Valve Frame Infolding in the 34mm Self-Expanding Medtronic Evolut Pro+ Transcatheter Valve System: A Single Centre Experience

Valve frame infolding (VFI) is a rare complication (1-3%) of transcatheter aortic valve implantation (TAVI), which primarily occurs in large sized self-expanding valves. We report the incidence of VFI in a small group of patients with highly calcified and extra-large aortic annuli, who underwent implantation of the newer generation 34mm Medtronic Evolut Pro+ (EP+) valve system. A retrospective review was conducted on all patients presenting to a single centre experienced with TAVI in Sydney, NSW, Australia, between June and October 2022, for transfemoral TAVI using the Medtronic 34mm EP+ valve system. VFI was diagnosed using fluoroscopy, and pre-procedure computed tomography (CT) was analysed offline. VFI occurred in four of 10 patients who underwent TAVI using the 34mm EP+ system. Between VFI and non-VFI patients, the annular size, aortic angulation and total calcium volume was similar. Calcium distribution between the coronary cusps was symmetrical in non-VFI patients (37%, 33% and 30%), compared to 52% in the non-coronary cusp (NCC) in VFI patients. The mean ellipticity index was higher in VFI versus non-VFI patients (22% vs 14%). The 34mm Medtronic EP+ valve system is vital for safe and effective treatment of a niche subgroup of patients with extra-large annuli and extensive calcification, however operators should be aware of the increased incidence of VFI. Heavy eccentric calcification at the NCC, as well as using the cusp-overlap implant technique may exacerbate VFI, while multiplanar fluoroscopic screening may improve recognition.

First Report of Evolut Pro+ Transcatheter Aortic Valve-in-Valve in a Degenerated Lotus Valve

The increasing use of transcatheter aortic valves in patients with aortic stenosis has led to a higher number of valve-in-valve procedures due to gradual valve degeneration. We present a case of a 72-year-old woman who received transcatheter aortic valve implantation (TAVI) using a Lotus valve due to severe aortic stenosis, which showed valve degeneration several years after the initial procedure. After heart-team discussion, TAVI-in-TAVI was planned using an Evolut pro+ valve, which allowed for full coverage of the Lotus valve and maintenance of coronary flow, resulting in a well-functioning valve with no regurgitation and normal performance. Despite high-risk anatomic features, valve-in-valve using an Evolut pro+ in a degenerated Lotus valve is feasible and overcomes pitfalls such as entanglement or coronary obstruction.

When valve needs electrical wires - estimating pacemaker implantation after TAVR

Abstract Introduction Widespread availability and expanded indication of transcatheter aortic valve replacement (TAVR) modified paradigm of aortic stenosis. Despite elevated success rate, there are procedure related complications that need to be considered. One of the most frequent is conduction defects requiring permanent pacemaker (PPM) implantation resulting in prolonged hospital length of stay and hospitalization cost. Several risk factors for PPM implantation after TAVI have been described, and, recently, the Emory Risk Score (ERS) was developed as a predictive tool for need of new PPM implantation post-TAVI in patients who implated a balloon-expandable valve. Purpose Our objective was to evaluate risk factors associated with PPM after TAVR and to validate the ERS in our population after implantation of balloon-expandable but also self-expanding valves. Methods Retrospective, observational and single center study involving patients submitted to TAVR between 2018 and 2021. Clinical, ECG data and procedure characteristics were obtained at time of TAVR and during follow-up. The predictive discrimination of the scoring system for the risk for PPM placement after TAVR was evaluated using ROC curve analysis in SPSS Statistics. To estimate additional predictors of pacemaker implantation we used Cox proportional hazards regression models. Results From January 2018 to December 2021, 416 patients were referred to our centre for TAVR. The mean age was 82,5 ± 6,1 years, 55% female. Most frequently implanted valves were Evolut Pro and Sapien 3 ultra in 39,4% and 26,6% of pts, respectively. During follow-up 110pts (26%) needed device implantation (94 % double chamber pacemaker; 6% CRT-P or CRT-D), most frequently due to AV block. On univariate analysis, QRS width was the only factor that showed a significant correlation with pacemaker implantation (HR 1,018, 95% CI 1,007-1028; p=0.027). We found no other clinical or procedural characteristics to be predictive of PM implantation. ERS is composed of 4 variables – history of syncope, right complete branch block, QRS width &amp;gt; 140mseg and valve oversizing &amp;gt; 16% - and revealed a good sensitivity and specificity in estimating device implantation. We applied this score to our population and ROC curve analysis showed a significant prediction capacity (AUC 0,761 95% CI 0,699-0,822, p=0,031). This analysis was also performed analysing separately both subgroups of self-expandable valves (Medtronic Evolut and Evolut R) and balloon expandable valves (Edwards Sapiens). ROC curve analysis in both showed a good correlation with events – figure 1. Conclusion PM implantation is one of the most common complications following TAVR. In our population, the use of ERS displayed a very positive accuracy in predicting device implantation. Routine use of such tool can select patients at significant higher risk and thus best define patient allocation and resource utilization to reduce number of hospitalization days.

Abstract 13177: The Association Between Insufficient Valve Expansion and Aortic Valve Calcification for Transcatheter Valve Implantation With Self-Expandable Valve

Background: Transcatheter aortic valve implantation (TAVI) has emerged as the preferred treatment for severe aortic stenosis. Nevertheless, severe calcification remains a factor leading to insufficient valve expansion and paravalvular leakage (PVL) after TAVI, mainly when using the self-expandable valve. We aimed to investigate the relationship between calcification and valve expansion using pre- and post-operative computed tomography (CT) scans, by comparing with valve phantoms as a reference standard. Methods: We enrolled 62 consecutive patients (mean age: 84.2 ± 4.4 years, 23 male) who underwent TAVI with the Evolut PRO+. We measured the aortic valve's calcium volume (Ca-Vol) by contrast-enhanced CT. The shorter diameter (mm) and the area (cm 2 ) of the base of the implanted valve were measured. We performed CT scans of valve phantoms for each size and defined the measured shorter diameter and the base area as the reference standard. We calculated the insufficiency of valve expansion as the ratio of the patient valve's shorter diameter and base area to that of the phantom valve. PVL was defined as more than mild regurgitation by transthoracic echocardiography. Results: The base area of valve phantoms was 3.6, 4.1, 6.4, and 8.4 cm 2 for 23, 26, 29, and 34 mm, respectively. The shorter diameter and base area of the implanted valve were 15.7 ± 2.6, 15.2 ± 2.8, 17.3 ± 4.0, 23.9 ± 1.8 mm, and 2.7 ± 0.7, 2.5 ± 0.6, 3.4 ± 1.0, and 6.2 ± 1.6 cm 2 for 23, 26, 29, and 34 mm (n=4, 31, 24, and 3, respectively). Significant inverse correlations were observed between Ca-Vol and shorter diameter ratio (r 2 = 0.1, P = 0.009), area ratio (r 2 = 0.1, P = 0.006), and PVL (r 2 = 0.4, P &lt; 0.001), respectively. On the other hand, there was no significant correlation between area ratio and PVL (r 2 = 0.004, P = 0.6). Conclusion: Severe calcification in the aortic valve was associated with insufficient valve expansion and PVL for the Evolut PRO+.