Balloon-expandable Transcatheter Research Articles

Novel Real-Time Fluoroscopic Assessment Method of Transcatheter Heart Valve Expansion Following Balloon-Expandable TAVR.

Transcatheter heart valve (THV) underexpansion after transcatheter aortic valve replacement may be associated with worse outcomes. THV expansion can be assessed fluoroscopically using a pigtail for calibration; however, the accuracy of this technique specific to transcatheter aortic valve replacement is unknown. We assessed the accuracy and reproducibility of a novel fluoroscopic method to assess THV expansion using the THV commissural post for calibration. Patients who underwent transcatheter aortic valve replacement with a SAPIEN 3 (S3) THV had documented 3 cusp and cusp overlap views, and post-implant computed tomography was identified. THV expansion was fluoroscopically assessed in the 3 cusp and cusp overlap views using the S3 commissural post height and the pigtail as a reference for calibration. The correlation between the 2 methods and computed tomography was evaluated. Forty patients were included. On the bench, the commissural post height measured 3.3, 3.5, 4.0, and 4.5 mm for the 20 mm S3, 23 mm S3, 26 mm S3, and 29 mm S3, respectively. The Pearson correlation coefficient (r) with computed tomography for measuring the inflow, mid-portion, and outflow THV diameter was 0.98, 0.97, and 0.98 for the commissural post height method and 0.82, 0.81, and 0.78 for the pigtail method, respectively. Unlike the pigtail method, the correlation between the commissural post height method and computed tomography remained strong across all THV sizes and in both the 3 cusp and cusp overlap views. The commissural post height method is a novel real-time fluoroscopic tool that has the potential to assess THV expansion and guide further optimization after balloon-expandable transcatheter aortic valve replacement.

Pacemaker implantation after surgical aortic valve replacement and balloon-expandable transcatheter aortic valve implantation: Incidence, predictors, and prognosis

Pacemaker implantation after surgical aortic valve replacement and balloon-expandable transcatheter aortic valve implantation: Incidence, predictors, and prognosis

Transcatheter mitral valve replacement to treat rheumatic mitral stenosis: a case series.

Rheumatic mitral stenosis (RMS) is a common valvular heart disease in developing countries. We sought to evaluate the early experience of patients with RMS undergoing transcatheter mitral valve replacement (TMVR). In this retrospective study, a total of 5 RMS patients accepted TMVR. All patients underwent computed tomography and echocardiography before having the procedure. After the preprocedural comprehensive evaluations, the surgeons planned to use the Prizvalve (a novel balloon-expandable transcatheter aortic valve system which is now under the clinical registration study) for TMVR. Clinical data were collected at baseline, before discharge, and at the 30-day follow-up. The median age of the 5 RMS patients was 61 years (range 60-77 years); 60% were male, and the median Society of Thoracic Surgeons score was 13.3% (range 6.2-17.1%). TMVR was successful in all patients. Postoperative transesophageal echocardiography showed that 60.0% (n = 3) of the patients had no paravalvular leakage and 40.0% (n = 2) had trace paravalvular leakage. The median postoperative peak velocity decreased to 1.4 m/s (range 1.1-1.7 m/s), and the median pressure gradient decreased to 3 mmHg (range 2-3 mmHg). No deaths occurred at the 30-day follow-up, and all patients had an improvement of ≥1 on the New York Heart Association functional rating. Our early experience with TMVR in RMS patients suggests that it is a safe and feasible procedure. The early results of the procedure are acceptable and provide bright prospects and directions for the precision treatment of RMS. ClinicalTrials.gov, identifier (NCT02917980).

Myval Transcatheter Heart Valve: The Future of Transcatheter Valve Replacement and Significance in Current Timeline.

The Myval is a balloon-expandable transcatheter heart valve (THV) developed by Meril Life Sciences Pvt. Ltd. (Vapi, Gujarat, India) that has an innovative operator-friendly design that aids in improving deliverability and features precise deployment. Various clinical studies demonstrate its effectiveness and safety, making it a promising choice in valvular interventions. Myval has been successfully utilized as a transcatheter aortic valve implantation (TAVI) device in cases with conduction disturbances, bicuspid aortic valve anatomy, non-calcified aortic regurgitation, dysfunctional stenosed right ventricular outflow tract (RVOT) conduits, pulmonary valve replacement, mitral valve replacement, and valve-in-valve and valve-in-ring implantation procedures. Myval's diverse sizes are also of key importance in complex cases of large annuli and complex anatomy. Further long-term studies are needed to consolidate these results. Its introduction signifies a significant advancement in cardiology, aiming to enhance patient outcomes and quality of life. In the present review, we provide an update on new-generation Myval THV series and review the available clinical data published to date with an emphasis on diverse use in specific clinical scenarios.

1-Year Outcomes of Transcatheter AorticValve Replacement Using a Self-Expanding vs Balloon-Expandable Transcatheter Aortic Valve.

Mid-term comparative data for the self-expanding ACURATE neo2 transcatheter heart valve and the balloon-expandable SAPIEN 3 Ultra are lacking. The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement of these 2 valves. A total of 2,106 patients from 3 centers (neo2, n=1,166; Ultra, n=940) undergoing transfemoral transcatheter aortic valve replacement were analyzed retrospectively. The primary endpoint was the composite of all-cause mortality, stroke, and rehospitalization at 1 year. Secondary endpoints were the individual components of the primary endpoint at 1 year. To adjust for baseline differences, nearest neighbor propensity score matching was used. After matching (702 pairs), baseline characteristics were similar between groups. Device success was more common in the neo2 group (87.5% vs 82.3%; P=0.007), irrespective of matching. DP mean after the procedure was higher for Ultra (13mmHg [Q1-Q3: 10-15mmHg] vs 8mmHg [Q1-Q3: 6-11] mmHg; P< 0.001). Rates of paravalvular leakage, device embolization, and multiple valve implantations were more common in the neo2 arm, whereas major cardiac structural complications and major vascular complications occurred more frequently in the Ultra group. All other in-hospital complication rates were similar between the 2 groups. At 1 year, the cumulative incidence of the primary endpoint (14.1% for neo2 vs 14.5% for Ultra; P=0.819) was similar between the groups. Likewise, the individual components showed no difference between the groups. Despite differing immediate results, the outcomes at 1 year, including the composite of all-causemortality, stroke, or hospitalization, were similar for neo2 and Ultra transcatheter heart valves.

Outcomes of Balloon-Expandable Transcatheter Aortic Valve Replacement in Younger Patients in the Low-Risk Era

Guidelines advise heart team assessment for all patients with aortic stenosis, with surgical aortic valve replacement recommended for patients younger than 65 years or with a life expectancy greater than 20 years. If bioprosthetic valves are selected, repeat procedures may be needed given limited durability of tissue valves; however, younger patients with aortic stenosis may have major comorbidities that can limit life expectancy, impacting decision-making. To characterize patients younger than 65 years who received transcatheter aortic valve replacement (TAVR) and compare their outcomes with patients aged 65 to 80 years. This retrospective registry-based analysis used data on 139 695 patients from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry, inclusive of patients 80 years and younger undergoing TAVR from August 2019 to September 2023. Balloon-expandable valve (BEV) TAVR with the SAPIEN family of devices. Comorbidities (heart failure, coronary artery disease, dialysis, and others) and outcomes (death, stroke, and hospital readmission) of patients younger than 65 years compared to patients aged 65 to 80 years. In the years surveyed, 13 849 registry patients (5.7%) were younger than 65 years, 125 846 (52.1%) were aged 65 to 80 years, and 101 725 (42.1%) were 80 years and older. Among those younger than 65, the mean (SD) age was 59.7 (4.8) years, and 9068 of 13 849 patients (65.5%) were male. Among those aged 65 to 80 years, the mean (SD) age was 74.1 (4.2) years, and 77 817 of 125 843 patients (61.8%) were male. Those younger than 65 years were more likely to have a bicuspid aortic valve than those aged 65 to 80 years (3472/13 755 [25.2%] vs 9552/125 001 [7.6%], respectively; P < .001). They were more likely to have congestive heart failure, chronic lung disease, diabetes, immunocompromise, and end stage kidney disease receiving dialysis. Patients younger than 65 years had worse baseline quality of life (mean [SD] Kansas City Cardiomyopathy Questionnaire score, 47.7 [26.3] vs 52.9 [25.8], respectively; P < .001) and mean (SD) gait speed (5-meter walk test, 6.6 [5.8] seconds vs 7.0 [4.9] seconds, respectively; P < .001) than those aged 65 to 80 years. At 1 year, patients younger than 65 years had significantly higher readmission rates (2740 [28.2%] vs 23 178 [26.1%]; P < .001) and all-cause mortality (908 [9.9%] vs 6877 [8.2%]; P < .001) than older patients. When propensity matched, younger patients still had higher 1-year readmission rates (2732 [28.2%] vs 2589 [26.8%]; P < .03) with similar mortality to their older counterparts (905 [9.9%] vs 827 [10.1%]; P = .55). Among US patients receiving BEV TAVR for severe aortic stenosis in the low-surgical risk era, those younger than 65 years represent a small subset. Patients younger than 65 years had a high burden of comorbidities and incurred higher rates of death and readmission at 1 year compared to their older counterparts. These observations suggest that heart team decision-making regarding TAVR for most patients in this age group is clinically valid.

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.

TCT-825 Hemodynamic Valve Deterioration in Under- vs Over-Expanded Balloon Expandable Transcatheter Aortic Valves

TCT-825 Hemodynamic Valve Deterioration in Under- vs Over-Expanded Balloon Expandable Transcatheter Aortic Valves

TCT-931 Outcomes of Self-Expanding vs Balloon-Expandable Transcatheter Aortic Valves in Patients With Small Aortic Annuli: A Meta-analysis

TCT-931 Outcomes of Self-Expanding vs Balloon-Expandable Transcatheter Aortic Valves in Patients With Small Aortic Annuli: A Meta-analysis

TCT-159 Comparison of the First- and Second-Generation Balloon-Expandable Transcatheter Aortic Valve in an Ovine, Aortic Banding Model

TCT-159 Comparison of the First- and Second-Generation Balloon-Expandable Transcatheter Aortic Valve in an Ovine, Aortic Banding Model

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.

Contemporary Outcomes and Trends for the Transseptal Mitral Valve-in-Valve Procedure Using Balloon Expandable Transcatheter Valves in the United States.

Previous transcatheter valve therapy registry analyses of transcatheter mitral valve in valve (MViV) replacement of degenerated bioprosthesis reported early experience in the United States. Given recent increases in transseptal MViV volumes and introduction of the SAPIEN 3 Ultra valve, it is important to determine contemporary outcomes for patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV replacement. The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry was used to extract data for all patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV from 2015 to September 2022. Primary efficacy outcome was 1-year all-cause mortality. Secondary end points included 30-day mortality, functional class, quality of life, and mitral valve performance. Primary safety outcomes were device success and in-hospital complications. A total of 4243 patients with a mean±SD STS score of 9.2±7.7 underwent transseptal MViV at 455 sites. The rate of Mitral Valve Academic Research Consortium technical (96.6%) success was high, and procedural complications were low. All-cause in-hospital, 30-day, and 1-year mortality rates were 3.2%, 4.3%, and 13.4%, respectively. Significant improvements in New York Heart Association class (New York Heart Association I/II, 18% to 87%) and quality of life (Kansas City Cardiomyopathy Questionnaire score, 38 to 78) were noted at 1 year (P<0.0001 for both) after MViV. Upon stratifying by STS scores, it was observed that the low-risk group (STS<4) had a significantly lower in-hospital mortality rate of 0.4%, whereas the intermediate-risk group (STS, 4-8) had an in-hospital mortality rate of 1.9%. From 2015 to 2022, the number of transseptal MViV cases/year increased significantly, whereas procedure times, length of stay, and intensive care unit hours shortened significantly. At the same time, there was a significant trend toward reduced in-hospital (P=0.0005), 30-day (P=0.004), and 1-year mortality rates (P=0.01). This multicenter, prospective study reports excellent procedural outcomes, acceptable 1-year mortality rates, and a significant improvement in quality of life for patients undergoing transseptal MViV in the contemporary era. Patients in the low-risk and intermediate-risk STS score categories had significantly better outcomes compared with those in the high-risk category. MViV is a reasonable therapy for the majority of patients with degenerated bioprosthetic mitral valves, who are anatomical candidates.

Performance of balloon-expandable transcatheter bioprostheses in inoperable patients with pure aortic regurgitation of a native valve: The BE-PANTHEON international project

BackgroundThe off-label utilization of transcatheter heart valve (THV) devices for the treatment of inoperable or high-surgical risk patients with pure native aortic valve regurgitation (NAVR) has demonstrated suboptimal outcomes, both with self- and balloon-expandable (BE) devices. The aim of this study is to compare the use of different BE scaffolds in treating pure NAVR. MethodsConsecutive patients with pure severe NAVR who were deemed to be at high-risk and were treated with last-generation BE-THVs among seventeen Centers in Europe and US. Technical and device success rates were the primary objectives. ResultsBetween February 2018 and July 2023, among 144 patients, 41 (28 %) received a MyVal device and 103 (72 %) were treated with a Sapien THV. Patients treated with a MyVal THV had an extra-large annulus more frequently compared to the Sapien group (49%vs.20 %, p < 0.001).Technical and device success rates were 90 % and 81 %, respectively, p > 0.1. The rate of THV migration/embolization (MyVal 4.9%vs. Sapien 11 %, p = 0.4) and second valve needed (4.9%vs.7.8 %, p = 0.7) were numerically lower in the MyVal group, whereas the rate of at least moderate paravalvular leak (15%vs.7.8 %, p = 0.2) and permanent pacemaker implantation (25%vs.18 %, p = 0.16) were numerically higher in the Myval group. ConclusionsOff-label use of BE devices for pure NAVR represents a potential alternative in high-risk patients in the absence of dedicated devices. However, BE in NAVR is associated with suboptimal outcomes. The availability of larger THV sizes may introduce transcatheter aortic valve replacement as an effective treatment for patients traditionally deemed unsuitable. Non-standard abbreviations and acronymsAR = aortic regurgitation, BE = balloon-expandable, NAVR = native aortic valve regurgitation, PM = pacemaker, TAVR = transcatheter aortic valve replacement, THV = transcatheter heart valve, TVEM = transcatheter valve embolization and migration, VARC-3 = Valve Academic Research Consortium 3.

Outcomes after transcatheter mitral valve implantation in valve-in-valve, valve-in-ring, and valve-in-mitral annular calcification.

We aimed to evaluate transcatheter mitral valve implantation (TMVI) using predominantly balloon-expandable transcatheter heart valves (THV) in patients with a landing zone for a percutaneously delivered prosthesis. Patients with a degenerated mitral valve bioprosthesis, annuloplasty ring, and mitral annulus calcification (MAC) considered at high surgical risk currently represent a treatment challenge. TMVI is an alternative treatment option. Retrospective analysis of patients with symptomatic degenerated mitral valve bioprosthesis, or annuloplasty ring, and MAC treated with TMVI between November 2011 and April 2021. Endpoints were defined according to Mitral Valve Academic Research Consortium (MVARC) criteria and included device and procedure success at 30 days as well as mortality at 30 days and 1 year after the procedure. A total of 77 patients underwent TMVI (valve in valve [ViV = 56], valve in ring [ViR = 11], and valve in MAC [ViMAC = 10]). There was a trend toward higher technical success (all = 93.5%, ViV = 96.4%, ViR = 90.9%, ViMAC = 80%, p = 0.06) and lower 30-day (all = 11.7%, ViV = 10.7%, ViR = 9.1%, ViMAC = 20%, p = 0.49) and 1-year mortality (all = 26%, ViV = 23.2%, ViR = 27.3%, ViMAC= 40%, p = 0.36) after ViV and ViR compared to ViMAC. TMVI represents a reasonable treatment option in selected patients with MAC or who are poor candidates for redo mitral valve surgery. Technical success and survival up to 1 year were not significantly dependent on the subgroup in which TMVI was performed.

One-Year Outcomes of Transseptal Mitral Valve-in-Valve in Intermediate Surgical Risk Patients.

Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study. This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year. A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients. Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801.

Deformation of a balloon-expandable transcatheter heart valve during transcatheter aortic valve replacement.

Deformation of a balloon-expandable transcatheter heart valve during transcatheter aortic valve replacement.

Impact of Different Valve-in-Valve Positions on Functional Results of the New Generation of Balloon-Expandable Transcatheter Heart Valve.

Very precise positioning of the transcatheter heart valve (THV) inside the degenerated SAV is a crucial factor for valve-in-valve (ViV) procedure to achieve optimal hemodynamic results. Therefore, our study aimed to investigate the impact of implantation depth on functional results after ViV procedures in a standardized in vitro setting. THV (SAPIEN 3 Ultra 23-mm size) and three SAV models (Magna Ease, Trifecta, and Hancock II-all 21-mm size) were tested at different circulatory conditions in five different positions of the THV (2-6 mm) inside the SAV. Mean pressure gradient (MPG), effective orifice area (EOA), geometric orifice area (GOAmax), and pinwheeling index (PWImean) were analyzed. EOA and MPG of the THV did not differ significantly regarding the position inside the Magna Ease and the Hancock II (p > 0.05). However, EOA differed significantly, depending on the position of the THV inside Trifecta (2 vs. 5 mm; p = 0.021 and 2 vs. 6 mm; p < 0.001). The THV presented the highest EOA (2.047 cm2) and the lowest MPG (5.387 mm Hg) inside the Magna Ease, whereas the lowest EOA (1.335 cm2) and the highest MPG (11.876 mm Hg) were shown inside the Hancock II. Additionally, the highest GOAmax and the lowest PWImean of the THV were noticed inside the Magna Ease. The THV showed lower GOAmax and higher PWImean inside the Trifecta when placed in a deeper position. Deep implantation of the SAPIEN 3 Ultra inside the Trifecta correlates with impaired functional results. In contrast, the implantation position of the SAPIEN 3 Ultra inside the Magna Ease and the Hancock II did not have a significant effect on functional results.

Early Structural Valve Deterioration of Balloon Expandable Transcatheter Aortic Valve Leaflets Due to Intrinsic and Extrinsic Nodular Calcification in a Hemodialysis Patient: A Case Report

Abstract Background Several reports have shown that transcatheter aortic valves are comparable in durability to surgical aortic valves. However, early structural valve deterioration (SVD) is rarely reported to occur, especially in hemodialysis patients. Case Summary We present a case of rapidly progressive bioprosthetic aortic valve stenosis in a patient with end-stage renal disease (ESRD) secondary to diabetic nephropathy in an 83-year-old female admitted due to progressive dyspnea and orthopnea. A 23-mm sized SAPIEN3 bioprosthetic aortic valve showed normal function for the first year after transcatheter aortic valve implantation (TAVI), but then rapidly developed stenosis and required acute hospitalization for heart failure a year and a half after surgery. Emergent surgical aortic valve replacement (SAVR) with a 19-mm On-X valve (CryoLife, Kennesaw, GA, USA) was performed. Pathological examination of the explanted SAPIEN 3 valve demonstrated severely degenerated bioprosthetic pericardial leaflets with severe intrinsic and extrinsic nodular calcification, which could limit the leaflet motion. Discussion There is a lack of reports on the long-term procedural outcomes of TAVI in hemodialysis patients. The development of SVD in patients undergoing dialysis is multifactorial and has yet to be fully elucidated. In the presented case, the removed TAVI valve had severe extrinsic calcified nodules alongside a fibrin thrombus. Considering these pathological findings, antithrombotic therapy to prevent fibrin thrombus from adhering to the TAVI valve may be important to avoid early SVD.

LB-9 | Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valve Replacement in Patients with Small Aortic Annuli: Additional Outcomes from the SMART Trial

LB-9 | Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valve Replacement in Patients with Small Aortic Annuli: Additional Outcomes from the SMART Trial

Off-Label Use of Balloon-Expandable Transcatheter Valves to Treat Pure Aortic Regurgitation

Transcatheter aortic valve implantation (TAVI) in native pure aortic regurgitation (AR) with off-label use of balloon expandable valves (BEV) has been reported. However, there are scant data regarding optimal oversizing and its safety and our study assessed BEV oversizing and outcomes of TAVI. Thirteen consecutive tricuspid aortic valve patients undergoing transfemoral TAVIs for pure AR with Sapien BEV at our centre between 2019 and 2023 (69.2% males, mean age 80.8 years, STS 4.0%) were divided into small annulus group (≤618mm2, SA) where ≥20% oversizing is achievable based on published data on BEV overexpansion, and larger annulus group (LA, >618mm2). Overexpansion and actual oversizing were measured on post-procedural CT scan. Technical success was 92.3% with one valve embolization in LA group. The post-procedural CT showed a mean 28.3% oversizing, significantly higher in SA (31.2%) then in LA group (19.4%), p= 0.0092. Oversizing ≥20% was achieved in 100% SA vs 33.3% LA patients (p=0.046). In conclusion, TAVI in pure AR with oversized Sapien BEV showed good procedural and short-term outcomes when ≥20% oversizing was predictably achievable.