Transcatheter Heart Valve Research Articles

TCT-928 Comparison of the Self-Expandable Acurate Neo 2 and the New Balloon-Expandable Myval Series Transcatheter Heart Valve at 4-Year Follow-Up

TCT-928 Comparison of the Self-Expandable Acurate Neo 2 and the New Balloon-Expandable Myval Series Transcatheter Heart Valve at 4-Year Follow-Up

TCT-86 Real-World 30-Day Outcomes for the SAPIEN 3 Ultra Resilia Transcatheter Heart Valve in the Treatment of Failed Bioprosthetic Mitral Valves: A Propensity-Matched Analysis

TCT-86 Real-World 30-Day Outcomes for the SAPIEN 3 Ultra Resilia Transcatheter Heart Valve in the Treatment of Failed Bioprosthetic Mitral Valves: A Propensity-Matched Analysis

Current Management and Therapy of Severe Aortic Stenosis and Future Perspective.

Intervention for severe aortic stenosis (AS) has dramatically progressed since the introduction of transcatheter aortic valve replacement (TAVR). Decades ago, controversies existed regarding comparing clinical outcomes between TAVR and surgical aortic valve replacement (SAVR) in various risk profiles. Recently, we discussed the durability of transcatheter heart valves and their lifetime management after aortic valve replacement (AVR). Regarding the management of AS, we discuss the appropriate timing of intervention for severe aortic stenosis, especially in asymptomatic patients. In spite of dramatic progression of intervention for AS, there are no established medications available to prevent or slow the progression of AS at present. Basic research and genome studies have suggested several targets associated with the progression of aortic valve calcification. Randomized controlled trials evaluating the efficacy of medications to prevent AS progression are ongoing, which might lead to new strategies for AS management. In this review, we summarize the current management of AS and the drugs expected to prevent the progression of AS.

Evolving capabilities of computed tomography imaging for transcatheter valvular heart interventions - new opportunities for precision medicine.

The last decade has witnessed a substantial growth in percutaneous treatment options for heart valve disease. The development in these innovative therapies has been mirrored by advances in multi-detector computed tomography (MDCT). MDCT plays a central role in obtaining detailed pre-procedural anatomical information, helping to inform clinical decisions surrounding procedural planning, improve clinical outcomes and prevent potential complications. Improvements in MDCT image acquisition and processing techniques have led to increased application of advanced analytics in routine clinical care. Workflow implementation of patient-specific computational modeling, fluid dynamics, 3D printing, extended reality, extracellular volume mapping and artificial intelligence are shaping the landscape for delivering patient-specific care. This review will provide an insight of key innovations in the field of MDCT for planning transcatheter heart valve interventions.

Early outcomes with a fully retrievable SinoCrown transcatheter heart valve in patients with severe aortic stenosis.

This study summarizes and analyzes data from patients suffering from symptomatic aortic stenosis who successfully underwent transcatheter aortic valve implantation (TAVI) using a novel, completely retrievable transcatheter heart valve. We included patients who underwent a TAVI procedure with SinoCrown valves at our center between December 2021 and September 2022. We collected 1-year follow-up data on survival, complications, echocardiographic results, New York Heart Association functional class in heart failure, and patient-reported health-related quality of life outcomes. Eight successive patients (73.3 ± 4.3 years) were included in the study, with a median Society of Thoracic Surgery risk score of 4.26%. The procedure had a 100% success rate. Median postoperative discharge time was 7 days, with no 30-day hospital readmissions. Postoperative aortic valve hemodynamics improved, indicated by decreased transvalvular flow velocity compared with preoperative values (1.9 ± 0.2 vs. 4.9 ± 0.2 m/s, p < 0.0001). The median and maximum follow-up times were 8 and 12 months, respectively. During the follow-up period, there were no serious complications such as death, stroke, valve embolization, or high-grade atrioventricular block. The results from eight initial TAVI cases performed with the SinoCrown valve demonstrated promising safety and efficacy.

TAVR-in-TAVR for High-Risk Anatomies: Demonstrating the Feasibility of Index Leaflet Overhang in a First-in-Human Case Report

Abstract Background TAVR-in-TAVR within index supra-annular transcatheter heart valves (THV) and high-risk anatomy can compromise coronary perfusion and re-access. Case Summary An 80-year-old male presented with acute heart failure caused by degeneration of an Evolut R THV, leading to severe aortic regurgitation. Aortic CT imaging revealed a high-risk anatomy characterized by the index THV's commissural plane being placed above the coronary ostia and a valve-to-aorta distance of less than 2 mm, resulting not eligible for redo-TAVR according to recent literature. The current case represents the first-in-human application of redo-TAVR with low SAPIEN 3 THV implantation within an Evolut R THV obtaining index leaflet overhang, preserving coronary perfusion and potential coronary re-engagement. Discussion Following in vitro study, this case demonstrates in vivo feasibility of redo-TAVR with low SAPIEN 3 THV implantation within an Evolut R THV obtaining index leaflet overhang.

CharActeristics, sizing anD outcomes of stenotic, tapered, rapHe-type bicuspid aOrtic valves treated with trans-catheter device implantation: Insights the AD HOC registry

BackgroundRaphe-type bicuspid aortic valve (BAV) is a potential hostile scenario in trans-catheter aortic valve replacement (TAVR) due to pronounced calcium burden, possibly associated with tapered valve configuration. Trans-Catheter heart valve (THV) sizing strategy (annular vs. supra-annular) is controversial in this valve subtype. ObjectivesTo describe the phenotypical characteristics of severe, tapered, raphe-type, BAV stenosis undergoing TAVR and to explore safety and efficacy of modern-generation THVs, analysing the impact of annular and supra-annular sizing strategies on short- and mid-terms outcomes. MethodsThis is a retrospective, multicenter registry enrolling consecutive stenotic Sievers type 1 BAV treated with TAVR. Study population was divided into tapered and non-tapered configuration according to MSCT analysis. Matched comparison between annular and supra-annular sizing groups was performed in tapered population. ResultsFrom January 2016 to June 2023, 897 patients were enrolled. Of them, 696 patients displayed a tapered configuration. Of those, 510 received a THV according to annular sizing. After propensity score matching 186 matched pairs were selected. Technical success (96.2 % vs 94.1 %, OR 1.61 [0.61–4.24], p = 0.34), 30-day device success (83.6 % in both groups, OR 1.42 [0.78–2.57], p = 0.25) and 30-day early safety (71.8 % vs 70.5 %, OR 1.07 [0.68–1.68], p = 0.78) were similar between the annular and supra-annular sizing groups; a higher post-TAVR gradient was observed in supra-annular group, although it was only 2 mmHg mean. At mid-term follow-up, the rate of clinical efficacy was 84.7 %. ConclusionsTAVR with modern-generation devices is safe and effective for tapered raphe-type BAV, showing comparable results for annular and supra-annular sizing strategies.

Benchtop Flow Stasis Quantification: In Vitro Methods and In Vivo Possibilities.

Neo-sinus flow stasis has ben correlated with transcatheter heart valve (THV) thrombosis severity and occurrence. Standard benchtop flow field quantification techniques require optical access or modified prosthesis models that may not reflect the true nature of the original valve. En face and fluoroscopic videodensitometry enable visualization of washout in regions otherwise unviewable. This study compares two in vitro methods of assessing flow stasis in scenarios with insufficient optical access for traditional techniques such as particle image velocimetry (PIV). A series of seven paired experiments were conducted using a previously described laser-enhanced video densitometry (LEVD) and fluoroscopic video densitometry (FVD). Both sets of experiments were analyzed to calculate washout time as a measure of flow stasis. A novel flow stasis measure termed contrast attenuation ratio (CAR) is proposed as a viable single measure of flow stasis obtainable from only a small number of cardiac cycles of in vitro or in vivo fluoroscopic data. Retrospective fluoroscopic datasets (n = 72) were analyzed to assess the feasibility of obtaining this metric from routine clinical practice and its ability to stratify results. Neo-sinus flow stasis calculated from in vitro fluoroscopy was well correlated with LEVD (r2 = 0.77, p = 0.009). The newly proposed CAR metric showed good agreement with the commonly used "washout time" measure of flow stasis (r2 = 0.91, p < 0.001) while allowing for assessment with incomplete or truncated data. As a proof of concept, CAR was measured in 72 consecutive retrospective fluoroscopic datasets. CAR averaged 10.6 ± 4.6% with a range of 1.5-20.3% in these patients. This study demonstrates two in vitro methods that can be used to assess relative flow stasis in otherwise optically inaccessible regions surrounding cardiac or vascular implants. In addition, the fluoroscopic benchtop technique was used to validate a metric that allows for extension to routine clinical fluoroscopy. This contrast attenuation ratio (CAR) metric was found to be both accurate and clinically obtainable, and potentially offers a new method for valve thrombosis risk stratification.

Surgical explantation of transcatheter heart valves: A single institution experience

ObjectiveOver the past decade, there has been a dramatic growth in the utilization and diversity of available transcatheter devices for the replacement and repair of all heart valves. The aim of this study is to examine temporal trends, failure profiles, and clinical outcomes involved in the surgical explantation of transcatheter valve prostheses. MethodsAdult patients undergoing surgical explantation of transcatheter valve prostheses between 2014 and 2022 at a single institution were identified. Retrospective cohort review and survival analysis were performed to assess patient characteristics, indications for explant, and operative outcomes. ResultsFrom 2014 to 2022, 8 surgeons at a single institution performed explantation of transcatheter valve prostheses in 44 patients. Among explanted devices, 50% were removed within 1 year of transcatheter implantation. Surgical explantation was performed on an urgent or emergent basis in 57% of patients. Indications for explantation included valve prosthesis failure (57%), iatrogenic injury (16%), and endocarditis (11%). Operative mortality was 11%, with a mean Society of Thoracic Surgeons mortality risk of 12%. Patients undergoing elective explantation had improved survival compared with those undergoing urgent or emergent explantation (P = .03). Overall survival was 77% at 3 years following transcatheter valve explantation. ConclusionsThere is a rising annual incidence of transcatheter valve explantation in all valve positions. Surgical explantation performed on both elective and non-elective bases is increasingly common in adult cardiac surgical practice. The clinical impact of transcatheter valve explantation is significant and should be strongly considered by multidisciplinary heart teams in the lifetime management strategy of cardiac valvular disease.

Transapical Transcatheter Aortic Valve Replacement Under 3-Dimensional Guidance to Treat Pure Aortic Regurgitation in Patients with a Large Aortic Annulus.

Transcatheter aortic valve replacement (TAVR) is a challenge for patients with aortic regurgitation (AR) and a large annulus. Our goal was to evaluate the clinical outcomes and predictors of transapical TAVR in AR patients with a large annulus and noncalcification and the feasibility and safety of 3-dimensional printing (3DP) in the preprocedural simulation. Patients with a large annulus (diameter >29 mm) were enrolled and divided into the simulation (n = 43) and the nonsimulation group (n = 82). Surgeons used the specific 3DP model of the simulation group to simulate the main steps before the procedure and to refit the transcatheter heart valve (THV) according to the simulated results. The average annular diameter of the overall cohort was 29.8 ± 0.7 mm. Compared with the nonsimulation group, the simulation group used a higher proportion of extra oversizing for THVs (97.6% vs. 85.4%, p = 0.013), and the coaxiality performance was better (9.7 ± 3.9° vs. 12.7 ± 3.8°, p < 0.001). Both THV displacement and ≥ mild paravalvular leakage (PVL) occurred only in the nonsimulation group (9.8% vs. 0, p < 0.001; 9.8% vs. 0, p < 0.001). Multivariate regression analysis showed that extra oversizing, coaxial angle and annulus diameter were independent predictors of THV displacement and ≥ mild PVL, respectively. Based on 3DP guidance, transapical TAVR using extra oversizing was safe and feasible for patients with noncalcified AR with a large annulus. Extra oversizing and coaxial angle were predictors of postprocedural THV displacement and ≥ mild PVL in such patients.

Supra-Annular Self-Expanding Versus Balloon-Expandable Valves for Valve-in-Valve Transcatheter Aortic Valve Replacement

Self-expanding (SE) and balloon-expandable (BE) transcatheter heart valves (THVs) have not been extensively studied in valve-in-valve transcatheter aortic valve replacement (ViV-TAVR). We compared outcomes of supra-annular SE and BE THVs used for ViV-TAVR via a retrospective analysis of institutional data (2013-2023) including all patients undergoing ViV-TAVR (TAVR in previous surgical AVR). Unmatched and propensity-matched (1:1) comparisons of clinical and echocardiographic outcomes were undertaken between SE and BE THV along with Kaplan-Meier survival analysis. A total of 315 patients undergoing ViV-TAVR were included of which 73% received a SE THV. Median age was 77 years and women comprised 42.5% of the population. Propensity-score matching (1:1) yielded 81 matched pairs. Implanted aortic valve size was comparable between the groups (23 mm [23-26] vs. 23mm [23-26], p=0.457). At 30 days following ViV-TAVR, the SE group had a lower mean aortic valve gradient (14 mmHg [11-18] vs. 17.5 mmHg [13-25], p=0.007). A higher number of BE patients had severe prosthesis-patient mismatch (PPM) (16% vs. 6.2%, p=0.04). At one-year follow-up, the SE group had a lower aortic valve gradient (14.0 mmHg [9.6-19] vs. 17 mmHg [13-25], p=0.04) compared to the BE group. 30-day mortality was 2.7% while one-year mortality was 7.5% and comparable between the groups. Survival and stroke incidence were similar in both groups up to 5 years. In conclusion, both SE and BE THVs had comparable survival following ViV-TAVR. The higher residual aortic valve gradients in BE THVs are likely due to valve design and warrant long-term evaluation for potential structural valve degeneration.

Sinus sequestration due to transcatheter heart valve endothelialization after transcatheter aortic valve replacement.

Sinus sequestration due to transcatheter heart valve endothelialization after transcatheter aortic valve replacement.

Thrombocytopenia after transcatheter aortic valve implantation

Introduction and objectivesThrombocytopenia frequently occurs after transcatheter aortic valve implantation (TAVI) but its impact is poorly understood. We aimed to analyze the incidence, clinical impact, and predictors of acquired thrombocytopenia after TAVI. MethodsThis retrospective multicenter registry included 3913 patients undergoing TAVI with a baseline platelet count of ≥ 100 *109/L. Acquired thrombocytopenia was defined as a decrease in baseline platelet count of ≥ 50% (early nadir ≤ 3 days and late nadir ≥ 4 days) post-TAVI. The primary endpoint was 30-day all-cause mortality and secondary endpoints were procedural safety and 2-year all-cause mortality. ResultsThe incidence of acquired thrombocytopenia was 14.8% (early nadir: 61.5%, late nadir: 38.5%). Thirty-day mortality occurred in 112 (3.0%) patients and was significantly higher in those with thrombocytopenia (8.5% vs 2.0%, adjusted OR, 2.3; 95%CI, 1.3-4.2). Procedural safety was lower and 2-year mortality was higher in patients with thrombocytopenia vs those without (52.1 vs 77.0%; P <.001, and 30.2% vs 16.8%; HR, 2.2, 95%IC, 1.3-2.7) and especially in those with late nadir thrombocytopenia (45.8% vs 54.5%; P=.056, and 38.6% vs 23.8%, HR, 2.1; 95%CI, 1.5-2.9). Independent predictors of thrombocytopenia comprised baseline and procedural factors such as body surface area, absence of diabetes, poorer renal function, peripheral vascular disease, nontransfemoral access, vascular complications, type of transcatheter heart valve, and earlier TAVI procedures. ConclusionsAcquired thrombocytopenia was common (15%) after TAVI and was associated with increased short- and mid-term mortality and decreased procedural safety. Moreover, late thrombocytopenia compared with early thrombocytopenia was associated with significantly worse clinical outcomes. Further investigations are needed to elucidate the etiologic mechanisms behind these findings.

Direct aortic TAVI via anterior right mini-thoracotomy using 32 mm myval for pure aortic regurgitation

BackgroundAortic regurgitation with dilated annulus presents a technical challenge for conventional transcatheter aortic valve implantation (TAVI) procedures.Case presentationWe report a case of an 84-year-old frail patient with a history of breathlessness found to have severe aortic regurgitation and moderately impaired left ventricular systolic function. The patient underwent a successful TAVI procedure using the XL-Myval 32 mm transcatheter heart valve (THV) via an anterior right mini-thoracotomy with a direct aortic approach. The patient recovered well post-operatively with good hemodynamic resolution.ConclusionsThis first in human case highlights the efficacy and potential of applying innovative approaches, such as the new sizes of Myval THV and direct aortic access via anterior right mini thoracotomy, in addressing challenging anatomical variations in TAVI procedures with good outcome.

CT-derived simulations to predict outcomes in patients undergoing transcatheter aortic valve implantation with an ACURATE Neo2 valve the PRECISE-TAVI cohort B trial.

Paravalvular leakage (PVL) and conduction disorders that require permanent pacemaker implantation (PPI) remain clinically relevant challenges after transcatheter aortic valve implantation (TAVI). Computed tomography-based simulations may predict the risk of significant PVL and PPI. To evaluate the feasibility and accuracy of preprocedural computer simulation with FEops HEARTguide™ to predict >trace PVL and PPI after TAVI with the self-expanding supra-annular ACURATE Neo2 transcatheter heart valve. Prospective multicenter observational study that included consecutive patients undergoing TAVI with an ACURATE Neo2 valve. Computer simulations were performed before the TAVI procedure as part of the preprocedural planning. Follow-up period for PPI and PVL was 30 days. Sixty-five patients were included (median age 81 years (25th-75th percentile 77-84.5)). New left bundle branch block occurred in five patients (7.7%) and PPI in two patients (3%). Contact pressure index (CPI) was similar for patients with vs without new conduction disorders. Patients with PPI had numerically higher CPI than those without PPI (median CPI 20.0% (25th-75th percentile 15.0-25.0) vs. 13.0% (25th-75th percentile 5.5-18), p = 0.27). More than trace PVL occurred in 30%. Median PVL was significantly lower in patients with none-trace PVL (3.2 mL/s [25th-75th percentile 2.2-5.0]), compared to mild PVL (5.2 mL/s [25th-75th percentile 3.2-10.3]) and moderate PVL (12.6 mL/s [25th-75th percentile 3.9-21.3])(p = 0.036). A simulated PVL-cutoff of 9.65 mL/s identified patients with >trace PVL (AUC 0.70 (95% CI 0.55-0.85), sensitivity 42%, specificity 95%). In our study FEops HEARTguide™ simulations identified patients at risk for >trace PVL with ACURATE Neo2 TAVI but not for PPI.

Mechanical Circulatory Support–Assisted Percutaneous Rescue of Ventricularly Embolized Transcatheter Heart Valve

Mechanical Circulatory Support–Assisted Percutaneous Rescue of Ventricularly Embolized Transcatheter Heart Valve

Comparable efficacy and safety for bicuspid aortic valve stenosis patients undergoing transcatheter aortic valve replacement with balloon-expandable or self-expanding valves using Wei's sizing method.

The present study aimed to investigate whether proper sizing can improve the procedural and clinical outcomes of transcatheter aortic valve replacement (TAVR) with new-generation self-expanding valves (SEVs) and balloon-expandable valves (BEVs) for treating bicuspid aortic stenosis (BAS). We retrospectively evaluated consecutive patients who underwent TAVR with Sapien 3 valves (Edwards Lifesciences, Irvine, CA) or Evolut R/PRO valves (Medtronic, Minneapolis, MN) for severe BAS from 2017 to 2022. The primary endpoints were device success rate and major adverse cardiac and cerebral events (MACCEs), including mortality, non-fatal myocardial infarction or disabling stroke, transcatheter heart valve failure, or clinically relevant valve thrombosis during follow-up. Our team employed a complementary approach of supra-annular sizing in addition to the conventional annular sizing method (Wei's method) to guide the TAVR procedures. We recruited a total of 75 consecutive patients, of whom 43 (57%) were treated with BEVs from October 2017 to June 2021, and 32 (43%) were treated with SEVs from July 2021 to December 2022. Device success was similar between the BEV and SEV groups (93% vs. 94%; p > 0.99), and no cases of annular rupture occurred in either group. Similar rates of moderate-to-severe paravalvular leak were observed in the BEV and SEV groups (5% vs. 6%, p > 0.99). At a median follow-up of 464 days, the MACCE rates were comparable between the two groups. In multivariate analysis, the presence of previous percutaneous coronary interventions (hazard ratio: 5.43; p = 0.039) and New York Heart Association functional class III/IV heart failure at 30 days of follow-up after TAVR (hazard ratio: 9.90; p = 0.037) were independently associated with long-term MACCEs. Our results demonstrated comparable efficacy and safety for BAS patients undergoing TAVR using either BEVs or SEVs when using Wei's sizing method.

Conduction Abnormalities after Transcatheter Aortic Valve Implantation: Incidence, Impact and Management Using CT Data Interpretation.

The demonstrated safety and effectiveness of transcatheter aortic valve implantation (TAVI) among low surgical risk patients opened the road to its application in younger low-risk patients. However, the occurrence of conduction abnormalities and need for permanent pacemaker implantation remains a frequent problem associated with adverse outcomes. The clinical implications may become greater when TAVI shifts towards younger populations, highlighting the need for comprehensive strategies to address this issue. Beyond currently available clinical and electrocardiographic predictors, patient-specific anatomical assessment of the aortic root using multi-sliced CT (MSCT) imaging can refine risk stratification. Moreover, leveraging MSCT data for computational 3D simulations to predict device-anatomy interactions may help guide procedural strategy to mitigate conduction abnormalities. The aims of this review are to summarise the incidence and clinical impact of new left bundle branch block and permanent pacemaker implantation post-TAVI using contemporary transcatheter heart valves; and highlight the value of MSCT data interpretation to improve the management of this complication.

Le gradient reste élevé après mon TAVI, que faire?

Over the past two decades, transcatheter aortic valve implantation (TAVI) has become a safe and effective therapeutic option for symptomatic and severe aortic stenosis, regardless of the surgical risk spectrum. With the expansion of TAVI indications to low-risk and younger patients, it is crucial to ensure satisfactory and durable hemodynamic outcomes to guarantee transcatheter heart valve (THV) longevity. However, secondary THV dysfunction may occur, often manifested by an increased transvalvular gradient. According to VARC-3 criteria, these dysfunctions can be attributed to four main mechanisms: 1) structural valve deterioration; 2) non-structural valve dysfunction; 3) thrombosis; 4) and endocarditis. Each mechanism leads to specific abnormalities, requiring a systematic diagnostic approach and appropriate treatment. This article illustrates, through two clinical cases, the diagnosis and management of secondary transvalvular gradient elevation after TAVI.

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.