Transcatheter Heart Valve Research Articles

Butterfly-Inspired Multiple Cross-Linked Dopamine-Metal-Phenol Bioprosthetic Valves with Enhanced Endothelialization and Anticalcification.

Valve replacement is the most effective means of treating heart valve diseases, and transcatheter heart valve replacement (THVR) is the hottest field at present. However, the durability of the commercial bioprosthetic valves has always been the limiting factor restricting the development of interventional valve technology. The chronic inflammatory reaction, calcification, and difficulty in endothelialization after the implantation of a glutaraldehyde cross-linked porcine aortic valve or bovine pericardium often led to valve degeneration. Improving the biocompatibility of valve materials and inducing endothelialization to promote in situ regeneration can extend the service life of valve materials. Herein, inspired by the hardening process of butterfly wings, this study proposed a dopamine-metal-phenol strategy to modify decellularized porcine pericardium (DPP). This is a strategy to make dopamine (DA) coordinate trivalent metal chromium ions (Cr(III)) with antiplatelets (PLTs) and anti-inflammatory properties, and then cross-link it with tea polyphenols (TP) to generate a valve scaffold that is mechanically comparable to glutaraldehyde-cross-linked scaffolds but avoids the cytotoxicity of aldehyde and presents better biocompatibility, hemocompatibility, anticalcification, and anti-inflammatory response properties.

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

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

Transcatheter aortic valve implantation using balloon-expandable Myval transcatheter heart valve in a patient with bicuspid aortic valve with low-flow, low-gradient severe aortic stenosis

Transcatheter aortic valve implantation is the most preferred treatment for aortic stenosis in elderly patients at high surgical risk. We share our experience with Transcatheter aortic valve implantation utilizing a balloon-expandable Myval transcatheter heart valve in a patient diagnosed with a bicuspid aortic valve, exhibiting low-flow, low-gradient severe aortic stenosis, along with annular calcification that extends to the left ventricular outflow tract and horizontal aorta.

Five-Year Outcomes with Self-expanding versus Balloon-expandable TAVI in Patients with Left Ventricular Systolic Dysfunction

The importance of transcatheter heart valve (THV) design on clinical outcome in patients with aortic stenosis (AS) and left ventricular (LV) systolic dysfunction remains unknown. We aimed to compare 5-year outcomes of patients with severe AS and reduced LV ejection fraction (LVEF), undergoing transcatheter aortic valve implantation (TAVI) with balloon-expandable vs. self-expanding THVs. In a retrospective analysis from the Bern TAVI registry, patients with LVEF <50% who underwent TAVI with either balloon-expandable or self-expanding THVs were included. A 1:1 propensity-score matching was performed to account for baseline differences between groups. A total of 759 patients were included between August 2007 and December 2022, and propensity-score matching resulted in 134 pairs. Technical success was achieved in over 85% of patients, and was similar in both groups. Self-expanding THVs were associated with a lower mean transvalvular gradient (7.1 ± 3.7 mmHg vs. 9.9 ± 4.3 mmHg; P <0.001) and a higher incidence of ≥mild-to-moderate paravalvular regurgitation (36.3% vs. 11.3%; P <0.001) compared to balloon-expandable THVs. At 5 years, patients treated with a self-expanding THV had higher all-cause mortality than those with a balloon-expandable THV (67.8% vs. 55.8%, HRadjusted: 1.44; 95% CI: 1.02-2.03; P = 0.037). There were no significant differences in other clinical outcomes up to 5 years between groups. In the setting of LV systolic dysfunction, patients treated with a self-expanding THV had higher risk of 5-year mortality compared to patients treated with a balloon-expandable THV. https://www. gov. NCT01368250.

Transapical Transcatheter Aortic Valve Implantation with the J-Valve System in Aortic Regurgitation

BackgroundAortic regurgitation (AR) is a condition associated with significant morbidity and mortality, particularly in severe cases. The J-valve system, next-generation transcatheter heart valve (THV), may overcome the procedural challenges associated with treating pure AR. This study reported the outcome of J-valve for treatment of AR. MethodsThis study observed 47 patients undergoing transcatheter aortic valve implantation (TAVI) with the J-Valve system. Diagnostic evaluation included transthoracic echocardiography and multislice computed tomography to assess AR severity and anatomical characteristics essential for TAVI. Follow-ups were conducted at various intervals post-operation to evaluate outcomes. ResultsThe patients had a mean age of 73.0±9.0 years and a median ejection fraction (EF) of 58.0% (IQR, 45.0%-64.0%). The median EuroSCORE II was 3.0% (IQR, 2.0%-6.7%).The procedural success rate was 100%, with no need for a second valve implantation or conversion to sternotomy. Short-term outcomes showed significant improvements in the New York Heart Association (NYHA) functional classification (P<0.001), left ventricular ejection fraction (LVEF) (P=0.009) and left ventricular end-diastolic diameter (LVEDD) (P<0.001). A singular case of valve migration and severe perivalvular leakage (PVL) due to Behçet's disease prompted a revised approach incorporating immunomodulation therapy. ConclusionsTAVI with the J-Valve system presents a viable alternative for managing severe AR, demonstrating high procedural success and substantial clinical improvement. However, the case of valve migration due to Behçet's disease highlights the need for careful preoperative screening and consideration of autoimmune disorders in differential diagnoses.

Five-year outcomes with self-expanding versus balloon-expandable transcatheter aortic valve replacement in patients with left ventricular systolic dysfunction

Abstract Background The importance of transcatheter heart valve (THV) design on clinical outcome in patients with aortic stenosis (AS) and left ventricular (LV) systolic dysfunction remains unknown. Objectives We aimed to compare 5-year outcomes of patients with severe AS and reduced LV ejection fraction (LVEF), undergoing transcatheter aortic valve replacement (TAVR) with balloon-expandable vs. self-expanding THVs. Methods In an institutional TAVR registry, patients with LVEF &amp;lt;50% who underwent TAVR with either balloon-expandable or self-expanding THVs were included. A 1:1 propensity-score matching was performed to account for baseline differences between groups. Results A total of 759 patients were included between August 2007 and December 2022, and propensity-score matching resulted in 134 pairs. Technical success was achieved in over 85% of patients, and was similar in both groups. Self-expanding THVs were associated with a lower mean transvalvular gradient (7.1 ± 3.7 mmHg vs. 9.9 ± 4.3 mmHg; P &amp;lt;0.001) and a higher incidence of ³mild-to-moderate paravalvular regurgitation (36.3% vs. 11.3%; P &amp;lt;0.001) compared to balloon-expandable THVs. At 5 years, patients treated with a self-expanding THV had higher all-cause mortality than those with a balloon-expandable THV (67.8% vs. 55.8%, Adjusted Hazard Ratio: 1.44; 95% CI: 1.02-2.03; P = 0.037). There were no significant differences in other clinical outcomes up to 5 years between groups. Conclusions In the setting of LV systolic dysfunction, patients treated with a self-expanding THV had higher risk of 5-year mortality compared to patients treated with a balloon-expandable THV.

Impact of SAPIEN3 Ultra RESILIA on improvement of valve performance: Insights from the multicenter registry: a propensity-score matched analysis

Abstract Backgrounds: Transcatheter aortic valve implantation (TAVI) is now a cornerstone treatment for symptomatic severe aortic stenosis across all risk profiles, including low-risk and younger patients. As such, the performance and durability of transcatheter heart valves (THVs) are paramount. SAPIEN3 Ultra RESILIA (S3 UR) is expected to improve hemodynamics compared with SAPIEN3 (S3) due to the use of RESILIA bovine pericardial tissue and modified sawing maneuvers for each of three leaflets in 20 and 23mm valves. Aim The aim of study was to evaluate the hemodynamic improvement with S3 UR compared to S3 who underwent TAVI. Methods In a multicenter TAVI registry, we identified 1,931 patients who received a balloon-expandable valve over the past three years. We focused on post-procedural effective orifice area (EOA), post-procedural indexed EOA (EOAi), incidence of prosthesis-patient mismatch (PPM), paravalvular leakage (PVL) and post-procedural mean pressure gradient (mean PG) as our primary endpoints. We preformed propensity score matching analysis using a 1:1 ratio. Parameters including aortic stenosis severity, % oversizing and post dilatation were incorporated into the matching model. Results Of patients, mean age was 84 years old and 37.9% were male. EOAi was significantly larger in S3 UR group than in the S3 group for both cohorts [overall cohort: 1.21 (1.02 – 1.36) vs. 1.08 (0.93 – 1.26), P = 0.001; propensity matched cohort: 1.21 (1.01 – 1.35) vs. 1.11 (0.91 – 1.27), p = 0.042, respectively] (Figure 1). Similarly, the degree of PVL was significantly less in the S3 UR group than in the S3 group for both cohorts. In the propensity matched cohort, mild PVL was identified in 6.5% vs. 14.7%, and moderate PVL was present in 0.0% vs. 1.6% (p = 0.028). Peak PG and mean PG were significantly lower in the S3 UR group than in the S3 group for both cohorts. In the propensity matched cohort, peak PG was 17.7 (14.3 – 24.5) vs. 23.2 (18.2 – 29.2) (p = 0.001) and mean PG was 9.0 (7.1 – 12.5) vs. 11.5 (8.9 -14.8) (p = 0.005), respectively. The incidence of PVL ≥ mild, mean PG ≥ 20 mmHg, moderate PPM and severe PPM were tend to be lower in S3 UR group than in the S3 group for both cohorts (Figure 2). Conclusion The S3 UR valve exhibits significant hemodynamic improvements compared to the S3 valve, underscoring its potential for improved clinical outcomes in TAVI patients.

Comparison of the effects of pre-dilatation with conventional versus larger balloon sizes on clinical outcomes in transcatheter aortic valve implantation with self-expandable valves

Abstract Background Transcatheter aortic valve implantation (TAVI) is considered an established treatment option for patients with severe aortic stenosis. When implanting self-expandable valve, pre-dilatation is often necessary to facilitate optimal transcatheter heart valve (THV) deployment. Traditionally, balloon sizes chosen for pre-dilatation are smaller than the minimum annulus diameter. Insufficient pre-dilatation can result in under-expansion of the THV, necessitating post-dilatation, and can increase the risk of complications. However, this conventional approach may not always yield the best outcomes, prompting a reassessment of balloon sizing strategies to improve procedural success and patient outcomes. Purpose The aim of this study was to investigate the impact on procedural outcomes of using larger balloons, sized less than the mean annulus diameter, for pre-dilatation compared to the traditional practice of using balloons sized less than the minimum annulus diameter during the implantation of self-expandable valves. Methods We analyzed 785 patients who underwent TAVI with self-expandable valve with pre-dilatation out of a consecutive 3880 cases at 6 centers from 2010 to 2023 (Figure 1). Among them, we divided the patients into two groups: those who underwent pre-dilation with balloons smaller than the minimum annulus diameter defined as the Conventional-size group and those who underwent pre-dilatation with balloons smaller than the mean annulus diameter defined as the Large-size group. The primary endpoint of this study was procedural success, stroke and need for permanent pacemaker implantation as designated by the VARC-3criteria. Results Of patients (69% female; mean age 84.9), there were 563 (71.7%) patients in the Conventional-size group and 222 (28.2%) patients in the Large-size group. There was no annulus rupture in either group. The incidence of post-dilatation was significantly higher in the Conventional-size group than in the Large-size group (109 of 563 [19.4%] vs. 23 of 222 [10.3%], p=0.001) (Figure 2). There was no significant difference in the incidence of primary endpoints (all p &amp;gt; 0.05). In post-echocardiographic outcomes, there was no significant difference in effective orifice area, mean pressure gradient, patients-prosthesis mismatch, or paravalvular leakage between the groups (P &amp;gt; 0.05). Conclusions This study demonstrates that a large-size strategy using a balloon smaller than the mean annulus diameter in the deployment of self-expandable valves is safe and may avoid the need for post-dilatation compared to the traditional strategy using a balloon smaller than the smallest diameter.

Correlation of prosthesis position on mid-term pacing burden in patients with new permanent pacemaker after TAVI

Abstract Background Prior studies suggest a strong correlation of the final prosthesis position on the occurrence of new conduction disturbances resulting in permanent pacemaker (PPM) implantation after transcatheter aortic valve implantation (TAVI). A high burden right ventricular pacing (PPM stimulation rate of &amp;gt; 20 %) is associated with poor long-term outcomes. So far, data about predictors influencing the PPM stimulation rate after TAVI are scarce. Purpose Thus, the purpose of this study was to evaluate the influence of the three-dimensional transcatheter heart valve (THV) position, as well as device landing zone characteristics or peri-/post-procedural factors on the stimulation rate in patients with new implanted PPM as TAVI complication. Materials: We evaluated the final THV position of 387 patients (106 with self-expanding Evolut R THV, 281 with balloon-expandable Sapien 3 THV) using fusion imaging of pre- and post-TAVI computed tomography angiography (CTA) to obtain a three-dimensional reconstruction of the THV within the native annulus region. The length of the THV above and below the native annulus was measured within the fused images to assess the implantation depth. PPM stimulation rates were examined pre-discharge and after 3 months. Patient’s clinical long-term outcome was evaluated over 5 years via standardized questionnaire as well as contacting general practitioners. Results Out of the 387 patients 112 (29%) received a new PPM pre-discharge after TAVI between 2014 and 2022. They were grouped into patients with stimulations rate below and above 20%. A stimulation rate &amp;gt; 20% in the PPM control before discharge and after three months was detected in 69 % and 67 % of them, respectively. Using uni- and multivariate logistic regression analysis, only new occurred third degree atrioventricular blocks (p=0.007) was identified as predictor for high burden right ventricular pacing after PPM-implantation as well as after 3 months. The implantation depth of the THV showed no influence on the PPM stimulation rate – neither the mean value nor the exact implantation depth adjacent the left, right and non-coronary cusp (P=0.455, P=0.108 and P=0.932, respectively). There were no significant differences regarding MACE between both groups during long-term follow-up; only the degree of dyspnea 5 years after TAVI was significantly higher in patients with a stimulation rate &amp;gt; 20% (p=0.01). Conclusion We detected no correlation of the exact three-dimensional THV position on mid-term pacing burden in 112 patients implanted with a new PPM after TAVI using CTA fusion imaging. Only a new occurred third degree atrioventricular block was a predictor for a high burden right ventricular pacing (stimulation rate &amp;gt;20%). These results provide important insights into which patients actually require PPM implantation after TAVI.

Polyphenol-treatment without preceding glutaraldehyde fixation: a potential paradigm change for bioprosthetic heart valves

Abstract Background Glutaraldehyde (GA) is the common fixative agent for bioprosthetic heart valves (BHVs). However, its chemical instability can expose calcium binding sites and, at commercially used concentrations, GA does not ensure effective immunological tolerance, triggering an immune response correlated to degeneration. Recently, polyphenols (PPs) achieved an almost complete xenoantigens inactivation in GA-fixed BHVs ensuring chemical stability of the treated tissue while improving mechanical characteristics and adding anti-infective and anti-thrombotic properties [1-4]. Purpose A new PP-based treatment has been introduced as a potential GA substitute in BHV manufacturing. The unique chemical properties of PPs permit them to interact with the tissue through stable chemical bonds without depolymerization over time, achieving several improvements that promise to extend the long-term durability of BHVs (Fig.1). Methods The study compared the effects of two cross-linking methods on bovine pericardial tissue: (1) traditional fixation in GA, and (2) treatment with PPs without GA. The type of chemical interaction between PPs and tissue was evaluated through nuclear magnetic resonance. The xenoantigens inactivation was quantified in-vitro by ELISA test and in-vivo in a humanized mouse animal model. Biomechanical properties were assessed through uniaxial stress-strain tests and cross-link density through the shrinkage temperature test. The protective effect against bacterial adhesion was evaluated against a strain of S aureus, while the inhibition of thrombosis was evaluated in-vivo in a pig animal model and in-vitro in a blood-loop using bovine blood with radio-labeled platelets. Results PPs effectuated multiple chemical bonds with and within the pericardium including cross-links based on covalent and hydrogen bonds, stacking, and electrostatic interactions. The inactivation of over 90% of surface-xenoantigens of the treated tissue allowed for superior biocompatibility (compared to &amp;lt;50% by commercial GA concentrations). The increase in elongation exhibited by PP-treated tissue confirmed excellent biomechanical features (Fig.2) while a sufficient degree of cross-linking was demonstrated through an adequate shrinkage temperature. Furthermore, a significant degree of bacterial adhesion (86% inhibition evaluated with S. aureus) and thrombus formation (Fig.2, up to 90% inhibition) were observed. Conclusion There is a real clinical need for improved chemical stability, calcification resistance, and immunological tolerance of current BHVs (surgical and transcatheter). PP technology may substitute the use of GA extending their performance and durability, thereby opening trans-catheter heart valves to younger patients. Reducing the need for mechanical heart valves would also address the associated risks of lifelong anticoagulation therapy.Figure 1Figure 2

Native Sinus Hemodynamics and Thrombosis in Transcatheter Heart Valve: Effect of Implant Depth and Coronary Flow.

This study aimed to investigate the hemodynamic and anatomic factors associated with sinus thrombosis following transcatheter aortic valve replacement (TAVR), integrating invivo patient data analysis and invitro experiments. Postprocedural, 4-dimensional, multiphase computed tomography data from 211 patients enrolled in the ADAPT-TAVR (Anticoagulation Versus Dual Antiplatelet Therapy for Prevention of Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement) study were analyzed. The prevalence of native sinus thrombosis was examined in relation to valve type, implant depth, and anatomic features. Invitro experiments used particle image velocimetry to observe changes in sinus flow based on the transcatheter heart valves (23-mm SAPIEN3, Edwards Lifesciences; and 29-mm CoreValve, Medtronic) height and coronary artery flow. Native sinus thrombosis was more common in self-expanding valves (39.1% versus 14.9%, P=0.004). In per-cusp analysis of invivo patient data, adjusted transcatheter heart valve implant depth (odds ratio, 1.2 [95% CI, 1.1-1.3]; P<0.001), noncoronary sinus of Valsalva (odds ratio, 4.0 [95% CI, 2.0-7.8]; P<0.001), sinus inflow diameter (odds ratio, 0.8 [95% CI, 0.6-0.9]; P=0.008), and implanted valve size (odds ratio, 0.8 [95% CI, 0.7-1.0]; P=0.025) were significant factors associated with native sinus thrombosis. In the invitro experiments, CoreValve showed noticeable flow stasis compared with SAPIEN3. High-positioned SAPIEN3 was linked to reduced velocity within the native sinus of Valsalva. Coronary artery flow led to higher sinus velocity and improved particle washout, reducing sinus thrombosis risk. This study provides insights into the relationship between transcatheter heart valve deployment and native sinus thrombosis, emphasizing the role of anatomic factors in relation to the risk of sinus thrombosis.

Comparing surgical techniques and results of secondary ischemic mitral regurgitation: a state-of-the-art literature review.

Surgery for mitral valve disease is a developing area with a wide range of surgical options. There is growing evidence on the best approach for secondary ischemic mitral regurgitation (SIMR) when the pathology is within the ventricle. The goal of this literature review is to provide a comprehensive comparison of surgical treatments for SIMR. The initial screening process included PubMed, Medline and Embase to identify randomized controlled trials, propensity-matched observational series, meta-analyses and unmatched observational series. The terms used were 'mitral valve disease', 'secondary mitral regurgitation', 'secondary ischemic mitral regurgitation', 'functional mitral regurgitation', 'restrictive mitral annuloplasty', 'subvalvular repair', 'Trans Catheter Edge to Edge Repair and echocardiography coupled with secondary mitral regurgitation', 'secondary ischemic mitral regurgitation', and 'functional mitral regurgitation'. Six strategies have been identified for treating SIMR. These include mitral valve replacement (MVR), restrictive mitral annuloplasty, surgical revascularisation (with and without mitral annuloplasty), subvalvular procedures [papillary muscle (PM) approximation, PM relocation, ring and string procedure], procedures directly targeting the mitral valve (edge-to-edge repair and anterior leaflet enlargement), and transcatheter heart valve therapy. There is a deficiency of robust empirical data to enable meaningful comparisons between MVR, mitral valve repair (including subvalvular repair), and transcatheter mitral valve procedure. This review will definitively analyze the current outcomes of transcatheter mitral valve procedure using the edge-to-edge mitral valve repair technique and standard surgical mitral valve procedures in patients with secondary mitral regurgitation (MR). In addition, the seminar highlights the role of left ventricular assist devices in managing SIMR. It discusses the advantages and limitations of each intervention. Currently, there is no consensus on the optimal management strategy for patients with SIMR. Therefore, a multidisciplinary cardiac team should manage patients with secondary MR to ensure the best outcome by matching the ideal intervention with the patient.

Successful transcatheter aortic valve implantation in a high-risk nonagenarian in Sri Lanka

Severe calcific aortic stenosis with repeated heart failure hospital admissions carries a high mortality and morbidity in the elderly. Despite a calculated high risk of periprocedural complications, Sri Lanka's first transcatheter heart valve replacement in an over 90-year-old patient in such a clinical condition could be performed with no major in-hospital adverse cardiac or cerebral events. Improved quality of life with freedom from repeated hospitalizations is an important clinical achievement in this age group following transcatheter heart valve therapy.

Impact of prior hospitalization for heart failure on clinical outcomes of patients after transcatheter aortic valve implantation with new-generation devices: Insights from the LAPLACE-TAVI registry.

A history of hospitalization for heart failure (HHF) before transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement is associated with the prognosis of patients with severe aortic stenosis (AS). However, the impact of prior HHF on clinical outcomes after contemporary TAVI using new-generation transcatheter heart valves (THVs) has not been thoroughly investigated. Using data from the aLliAnce for exPloring cLinical prospects of AortiC valvE disease (LAPLACE)-TAVI registry, we investigated 2,752 patients who underwent TAVI with new-generation THVs with a median follow-up of 627 days. The primary outcomes were all-cause mortality and heart failure readmission after TAVI. Patients with a history of HHF (n = 809) showed a higher 30-day mortality than patients without prior HHF (n = 1,943). A Kaplan-Meier analysis revealed that the prior HHF group showed a higher incidence of the primary outcome than the non-prior HHF group (27.4% vs. 16.4%, log-rank p = 0.001). In a Cox regression analysis, prior HHF was significantly associated with the risk of the primary outcome, even after adjusting for covariates (hazard ratio, 1.344; 95% confidence interval, 1.103-1.638; p = 0.003). A subanalysis showed that the prior HHFgroup with ejection fraction (EF) ≥ 50% had a higher risk of the primary outcome than the non-prior HHFgroup, whereas the prior HHF group with EF < 50% had the worst outcome. A history of prior HHF is associated with worse outcomes in patients with severe AS, both in those with preserved EF and those with reduced EF, even after TAVI using new-generation devices.

The novel balloon-expandable Myval transcatheter heart valve: systematic review of aortic, mitral, tricuspid and pulmonary indications

Introduction and objectivesMyval technology represents the first balloon-expandable alternative since the Edwards system became commercially available. Despite certain controversies, its use has rapidly expanded. We aimed to gather all the available literature regarding its indications and outcomes. MethodsA comprehensive search of articles published between December 2016 and May 2024 was conducted using BioMedCentral, Google Scholar, and PubMed to evaluate the main outcomes of Myval for native aortic stenosis (AS) (meta-analysis) and off-label uses (systematic review). ResultsA total of 151 studies were identified, and 74 were included in the analysis, covering aortic (n=51), mitral (n=9), tricuspid (n=6), and pulmonary (n=8) valve positions. A meta-analysis of studies on native AS demonstrated that Myval is safe and effective, with a 30-day mortality rate of 1.3%, good hemodynamic performance, low rates of pacemaker implantation (8.8%), and ≥ moderate paravalvular regurgitation (1.3%). Compared with other contemporary devices, Myval was competitive and associated with lower rates of pacemaker implantation. In a systematic review of off-label indications, Myval was also found to be safe and effective. In bicuspid AS, pure regurgitation, and aortic valve-in-valve procedures, success rates were 100%, 92%, and 100%, respectively, with pacemaker rates of 9.9%, 22.2%, and 3%, respectively. For mitral valve-in-valve/in-ring procedures, the success rate was 96.9%, while in tricuspid and pulmonary positions, small case series reported 100% success rates for both, with minimal procedural complications. ConclusionsMyval technology is safe and effective for the treatment of native valvular disease and dysfunctional prostheses or rings in all heart valve positions, although larger scale studies are warranted.

Direct Implantation of Transcatheter Valve in Mitral Annular Calcification: A Multi-Center Study

BACKGROUNDMitral valve replacement (MVR) in the setting of severe annular calcification (MAC) is associated with high morbidity and mortality. Direct surgical implantation of a transcatheter heart valve (THV) through a trans-atrial approach is a strategy to mitigate surgical risk. This study reports the peri-operative and 1-year outcomes of MVR using a THV in patients with severe circumferential MAC at three Canadian centers. METHODSCharts were reviewed between 1/1/2018 and 30/9/2023 to identify patients with severe circumferential MAC who had undergone direct implantation of a THV. Primary outcomes were 30-day mortality, debilitating stroke, and 1-year mortality. Secondary outcomes included left ventricular outflow tract obstruction (LVOTO), degree of PVL, transvalvular mean pressure gradient, and length of stay. RESULTSTwenty-two patients at the three centres underwent direct implantation of a THV. Nineteen were female with mean age 70.41±9.33 years. A THV was successfully implanted in all patients. There were two deaths at 30-days. Four died from non-cardiac causes at 1-year, and 1 patient had a post-operative stroke. Seventeen (77%) patients had none/trace paravalvular leak, 4 had mild PVL, and one patient had mild-moderate PVL. Mean trans-valvular gradient was 4.42±4.40. There were no cases of LVOTO. CONCLUSIONSDirect deployment of a THV in patients with severe MAC may be a reasonable option. Thirty-day and 1-year mortality rates of 9% and 18%, respectively, suggest that this approach should be reserved for high-risk patients who are not able to undergo conventional strategies.

TCT-951 Is the Pinwheeling Index a Potential Surrogate for Accelerated Leaflet Failure in Transcatheter Heart Valves?

TCT-951 Is the Pinwheeling Index a Potential Surrogate for Accelerated Leaflet Failure in Transcatheter Heart Valves?

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 (TAVR) with Evolut FX up until October 2023. Patients who underwent TAVR with Evolut EPO between 2018 and 2020 (n = 1128), and those with Evolut EPO+ between 2020 and 2023 (n = 1696) served as control groups. 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 (PS)-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 (PMI) rates (11.2% vs. 6.1% vs. 7.7%, respectively; p < 0.01) differed significantly. In the PS-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), while all vascular complications (4.6% vs. 4.6%, respectively; p = 1.00) and new PMI (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 Evolut EPO+, Evolut FX was associated with a lower incidence of in-hospital bleeding complications and may reduce an in-hospital stroke incidence.

On the accuracy of the segmentation process and transcatheter heart valve dimensions in TAVI patients

Accurate segmentation of medical images is critical for generating patient-specific models suitable for computational analyses, particularly in the context of transcatheter aortic valve implantation (TAVI). This study aimed to quantify the accuracy of the segmentation process from medical images of TAVI patients to understand the uncertainty in patient-specific geometries. We also quantified discrepancies between actual and CT-related diameter measurements due to artifacts and intra-observer variability. Segmentation accuracy was assessed using both synthetic phantom models and patient-specific data. The impact of voxelization and CT scanner resolution on segmentation accuracy was evaluated, while the intersection over union (IoU) metric was used to compare the consistency of different segmentation methodologies. The voxelization process introduced a marginal error (<1%) in phantom models relative to CAD models. CT scanner resolution impacted segmented model accuracy only after a 7.5-fold increase in voxel size compared to the baseline medical image. IoU analysis revealed higher segmentation accuracy for calcification (93.4 ± 3.1 %) compared to the aortic wall (85.4 ± 8.4 %) and native valve leaflets (75.5 ± 6.3 %). Discrepancies in THV diameter measurements highlighted a ∼5 % error due to metallic artifacts, with variability among observers and at different THV heights. Errors due to voxel size, segmentation methodologies and CT-related artifacts can impact the reliability of patient-specific geometries and ultimately computational predictions used to asses clinical outcomes and enhance decision-making. This study underscores the importance of accurate segmentation and its standardization for patient-specific modeling of TAVI simulations.

TCT-138 The Effect of Transcatheter Heart Valve Size and Deployment Height on Eccentricity in Bicuspid Aortic Valve: A Patient-Specific Simulation Study

TCT-138 The Effect of Transcatheter Heart Valve Size and Deployment Height on Eccentricity in Bicuspid Aortic Valve: A Patient-Specific Simulation Study