Bicuspid Aortic Stenosis Research Articles

Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement in Bicuspid Aortic Valve Stenosis-We Need a Well-Designed Randomized Control Trial.

Bicuspid aortic stenosis is a common pathology, typically seen in patients a decade younger than those with tricuspid valves. Surgical aortic valve replacement has been the mainstay treatment for bicuspid disease, especially considering the prevalence of concomitant aortic aneurysmal pathology. Transcatheter aortic valve replacement has shown equivalent results in bicuspid compared to tricuspid pathology in highly selected patient populations in single-arm registries and observational studies. For older patients with favorable bicuspid pathology, TAVR is reasonable. However, as younger patients with longer life expectancy are now being treated with TAVR, what is "best" is a question only answered by a well-designed randomized controlled trial. Herein, we describe the current evidence for treating bicuspid aortic stenosis and provide a framework for future trials. Yet, the question of equipoise remains, and who will we enroll?

Successful surgical repair of aortic root rupture during transcatheter aortic valve implantation: a case report

BackgroundAortic root rupture is a rare but potentially fatal complication of transcatheter aortic valve implantation (TAVI). Herein, we report a case of aortic root rupture during TAVI that was successfully managed with partial aortic root repair and aortic valve replacement.Case presentationAn 83-year-old woman with severe bicuspid aortic stenosis underwent transfemoral TAVI using a 26 mm SAPIEN 3 Ultra RESILIA valve. Soon after valve implantation, transesophageal echocardiography detected pericardial effusion, which was accompanied by immediate hemodynamic instability. Subxiphoid pericardial drainage was performed, and extracorporeal membrane oxygenation was promptly initiated. Owing to the eruptive hemorrhage, we converted to open-heart surgery. Direct visualization enabled the detection of the aortic root rupture and the performance of partial aortic root repair using bovine pericardium and aortic valve replacement using a 19 mm INSPIRIS RESILIA valve. The patient was transferred to a different hospital 60 days after surgery without complications and is currently doing well as an outpatient.ConclusionsIn the present case, prompt treatment decisions and smooth cooperation among the institutional heart team led to the successful repair of aortic root rupture during TAVI and good clinical outcomes.

Conduction Disturbances and Outcome After Surgical Aortic Valve Replacement in Patients With Bicuspid and Tricuspid Aortic Stenosis.

This study aimed to compare the incidence and prognostic implications of new-onset conduction disturbances after surgical aortic valve replacement (SAVR) in patients with bicuspid aortic valve (BAV) aortic stenosis (AS) versus patients with tricuspid aortic valve (TAV) AS (ie, BAV-AS and TAV-AS, respectively). Additionally, the study included stratification of BAV patients according to subtype. In this cohort study, the incidence of postoperative third-degree atrioventricular (AV) block with subsequent permanent pacemaker requirement and new-onset left bundle-branch block (LBBB) was investigated in 1147 consecutive patients without preoperative conduction disorder who underwent isolated SAVR (with or without ascending aortic surgery) between January 1, 2005, and December 31, 2022. The groups were stratified by aortic valve morphology (BAV, n=589; TAV, n=558). The outcomes of interests were new-onset third-degree AV block or new-onset LBBB during the index hospitalization. The impact of new-onset postoperative conduction disturbances on survival was investigated in BAV-AS and TAV-AS patients during a median follow-up of 8.2 years. BAV morphology was further categorized according to the Sievers and Schmidtke classification system (possible in 307 BAV-AS patients) to explore association between BAV subtypes and new-onset conduction disturbances after SAVR. The overall incidence of third-degree AV block and new-onset LBBB after SAVR was 4.5% and 7.8%, respectively. BAV-AS patients had a higher incidence of both new-onset third-degree AV block (6.5% versus 2.5%; P=0.001) and new-onset LBBB (9.7% versus 5.7%; P=0.013) compared with TAV-AS patients. New-onset LBBB was associated with an increased all-cause mortality during follow-up (adjusted hazard ratio, 1.60 [95% CI, 1.12-2.30]; P=0.011), whereas new-onset third-degree AV block was not associated with worse prognosis. Subgroup analysis of the BAV cohort revealed that BAV-AS patients with fusion of the right- and non-coronary cusps had the highest risk of new-onset third-degree AV block (adjusted odds ratio [aOR], 8.33 [95% CI, 3.31-20.97]; P<0.001, with TAV as reference group) and new-onset LBBB (aOR, 4.03 [95% CI, 1.84-8.82]; P<0.001, with TAV as reference group), whereas no significant association was observed for the other BAV subtypes. New-onset LBBB after SAVR is associated with increased all-cause mortality during follow-up, and is more frequent complication in BAV AS patients compared with TAV-AS patients. BAV-AS patients with fusion of the right- and non-coronary cusps have an increased risk for conduction disturbances after SAVR. This should be taken into consideration when managing these patients.

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.

TCT-902 Using “Cusp-Overlap” Technique in Type 0 Bicuspid Aortic Stenosis Undergoing Self-Expanding TAVR

TCT-902 Using “Cusp-Overlap” Technique in Type 0 Bicuspid Aortic Stenosis Undergoing Self-Expanding TAVR

TCT-136 We Tested a Novel CT-Guided Algorithm for Transcatheter Aortic Valve Implantation Sizing and Placement in Patients With Severe Bicuspid Aortic Stenosis Incorporating Both Downsizing and Supra-Annular Placement Using Sapien Ultra Prostheses

TCT-136 We Tested a Novel CT-Guided Algorithm for Transcatheter Aortic Valve Implantation Sizing and Placement in Patients With Severe Bicuspid Aortic Stenosis Incorporating Both Downsizing and Supra-Annular Placement Using Sapien Ultra Prostheses

Incidence and predictors of continued ascending aortic dilatation after TAVI in patients with bicuspid aortic stenosis

Abstract Background Patients undergoing transcatheter aortic valve implantation (TAVI) for bicuspid aortic stenosis (AS) frequently present with ascending aortic (AAo) dilatation which is left untreated. The objective of this study was to study the natural progression and underlying mechanisms of AAo dilatation after TAVI for bicuspid AS. Methods Patients with a native bicuspid AS and a baseline AAo maximum diameter &gt; 40 mm treated by TAVI and in whom post-TAVI computed tomography (CT) scans beyond 1 year were available were included. AAo dilatation was deemed to be either continuous (≥ 2 mm increase) or stable (&lt; 2 mm increase or decrease). Uni- and multivariate logistic regression analysis was utilized in order to identify factors associated with continuous AAo dilatation post-TAVI. Results A total of 61 patients with a mean AAo maximum diameter of 45.6 ± 3.9 mm at baseline were evaluated. At a median follow-up of 2.9 years, AAo dimensions remained stable in 85% of patients. Continuous AAo dilatation was observed in 15% of patients at a rate of 1.4 mm/year. Factors associated with continuous AAo dilatation were raphe length/annulus mean diameter ratio (OR 4.09, 95% CI [1.40–16.7], p = 0.022), TAV eccentricity at the leaflet outflow level (OR 2.11, 95%CI [1.12–4.53], p = 0.031) and maximum transprosthetic gradient (OR 1.30, 95%CI [0.99–1.73], p = 0.058). Conclusions Ascending aortic dilatation in patients undergoing TAVI for bicuspid AS remains stable in the majority of patients. Factors influencing TAV stent frame geometry and function were identified to be associated with continuous AAo dilatation after TAVI; this should be confirmed in future larger cohort studies. Graphical Abstract

Association of Lipoprotein(a) With Severe Degenerative Aortic Valve Stenosis

BackgroundLipoprotein(a) (Lp[a]) is associated with the development of aortic valve calcification. ObjectivesThe aim of this study was to evaluate the association between the serum level of Lp(a) and the development of severe degenerative aortic stenosis (AS) and subsequent aortic valve replacement (AVR). MethodsA total of 44,742 patients with Lp(a) measurements and echocardiography at baseline evaluation between 2000 and 2020 were included from a single tertiary heart center. The primary outcome was the development of severe degenerative AS, defined as a transaortic maximal velocity of ≥4.0 m/s. ResultsDuring a median follow-up period of 6.8 years (Q1-Q3: 2.3-12.4 years), severe degenerative AS was diagnosed in 472 patients (1.1%), and subsequent AVR was performed in 387 patients (0.9%). Lp(a) levels were associated with risk for severe degenerative AS, with levels of 30 to 50, 50 to 100, and >100 mg/dL demonstrating adjusted HRs of 1.02 (95% CI: 0.78-1.34; P = 0.88), 1.18 (95% CI: 0.91-1.53; P = 0.22), and 1.96 (95% CI: 1.31-2.94; P = 0.001) compared to <30 mg/dL. Similarly, the risk for AVR due to severe degenerative AS was significantly associated with higher levels of Lp(a) (>100 mg/dL) (adjusted HR: 2.05; 95% CI: 1.31-3.19; P = 0.002). Such associations were not observed in the development of severe bicuspid (P = 0.63) or rheumatic (P = 0.96) AS. ConclusionsLp(a) levels >100 mg/dL were significantly associated with risk for severe degenerative AS and subsequent AVR, regardless of the baseline severity of AS. Such associations were not observed in other etiologies of severe AS.

Right Parasternal Approach for Aortic Valve Replacement After Presternal Gastropexy.

Due to bicuspid aortic valve aortic stenosis, a 78-year-old man with a history of esophagectomy and presternal gastric tube reconstruction required aortic valve replacement (AVR). AVR with a bioprosthetic valve was performed through a right parasternal thoracotomy. Despite the unfavorable conditions for conventional median sternotomy, AVR was successfully performed through an alternate approach. The right parasternal approach was excellent for AVR in patients with presternal gastric tube reconstruction for esophageal cancer (EC).

Balloon-Expandable vs Self-Expanding Valves for Transcatheter Treatment of Sievers Type 1 Bicuspid Aortic Stenosis.

Balloon-expandable valves (BEVs) and self-expanding valves (SEVs) have different features that may impact the outcomes of patients with Sievers type 1 bicuspid aortic valve (BAV) stenosis undergoing transcatheter aortic valve replacement. This study sought to compare procedural and clinical outcomes of BEVs and SEVs in Sievers type 1 BAV stenosis. AD-HOC (Characteristics, Sizing, and Outcomes of Stenotic Raphe-Type Bicuspid Aortic Valves Treated With Transcatheter Device Implantation) is an observational registry enrolling patients with Sievers type 1 BAV stenosis undergoing transcatheter aortic valve replacement with current-generation BEVs and SEVs at 24 international centers. A 1:1 propensity score matching analysis was performed to adjust for baseline imbalances. The primary endpoint was midterm major adverse events, defined as a composite of all-cause death, neurologic events, or hospitalization for heart failure. Among 955 eligible patients, propensity score matching resulted in 301 pairs. At a median follow-up of 1.3years, BEVs and SEVs had a similar risk of major adverse events (BEV vs SEV: HR: 0.75; 95%CI: 0.49-1.16; P = 0.200). Technical success was similar (OR: 1.38; 95%CI: 0.63-3.04; P = 0.421). At 30days, BEVs were associated with a lower risk of new permanent pacemaker implantation (OR: 0.42; 95%CI: 0.24-0.72; P = 0.002) and moderate or greater paravalvular regurgitation (OR: 0.16; 95%CI: 0.05-0.48; P = 0.001) but a higher risk of severe patient-prosthesis mismatch (OR: 3.03; 95%CI 1.02-8.95; P = 0.045). Current-generation BEVs and SEVs proved similar technical success and midterm clinical efficacy in Sievers type 1 BAV stenosis. Compared to SEVs, BEVs were associated with less permanent pacemaker implantation and moderate or greater paravalvular regurgitation but with more severe patient-prosthesis mismatch.

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, nonfatal myocardial infarction or disabling stroke, transcatheter heart valve failure, or clinically relevant valve thrombosis during follow-up. Our team used a complementary approach of supraannular 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.

Two-year follow-up of transcatheter aortic valve replacement in low-risk patients with symptomatic severe bicuspid aortic valve stenosis.

In 2019, the US Food and Drug Administration (FDA) approved transcatheter aortic valve replacement (TAVR) for low-risk patients with symptomatic severe tricuspid aortic stenosis. However, bicuspid aortic valve (BAV) patients were included only in single-arm registries of pivotal low-risk TAVR trials, resulting in limited data for this subgroup. The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and the firstFDA-approved investigational device exemption trial to evaluate the feasibility of TAVR with balloon-expandable or self-expanding valves in low-risk patients with symptomatic severe BAV stenosis. This analysis reports 2-year follow-up, assessing the primary outcome of all-cause mortality and evaluating clinical outcomes. From 2016 to 2019, a total of 72 low-risk patients diagnosed with symptomatic, severe BAV stenosis underwent TAVR across six centers. Six patients were lost to follow-up. At 2-year follow-up, mortality was 1.5% (1 of 66 patients). Among the remaining 65 patients, four experienced nondisabling strokes (6.2%), while 2 (3.1%) developed infective endocarditis. No new permanent pacemakers were required beyond the 30-day follow-up, and no patients, including those with endocarditis, needed aortic valve re-intervention. At the 2-year echocardiography follow-up (n = 65), 27.8% of BAV patients showed mild aortic regurgitation, with none exhibiting moderate or severe regurgitation. The mean aortic gradient was 12.1 ± 4.1 mmHg, and the mean valve area was 1.7 ± 0.5 cm². The 2-year follow-up confirms commendable clinical outcomes of TAVR in patients with bicuspid aortic stenosis, establishing its evident safety.

Indexed aortic valve area using multimodality imaging for assessing the severity of bicuspid aortic stenosis

BackgroundThe impact of various imaging modalities on discordance/concordance between indexed aortic valve area (iAVA) and catheterization-derived mean transaortic pressure gradient (mPGcath) is unclear in patients with bicuspid aortic valve (BAV). This study aimed to compare iAVA measurements obtained using four different methodologies in BAV and tricuspid aortic valve (TAV) patients, using mPGcath as a reference standard. MethodsWe retrospectively reviewed patients who underwent comprehensive assessment of AS, including two-dimensional (2D) transthoracic echocardiography (TTE), three-dimensional (3D) transesophageal echocardiography (TEE), multidetector computed tomography (MDCT), and catheterization, at our institution between 2019 and 2022. iAVA was measured using the continuity eq. (CE) with left ventricular outflow tract area obtained by 2D TTE, 3D TEE, and MDCT, as well as planimetric 3D TEE. Results and ConclusionsAmong 564 patients (64 with BAV and 500 with TAV), 64 propensity-matched pairs of patients with BAV and TAV were analyzed. iAVACE(2DTTE) led to overestimation of AS severity (BAV, 23.4%; TAV, 28.1%) and iAVACE(MDCT) led to underestimation of AS severity (BAV, 29.3%; TAV, 16.7%), whereas iAVACE(3DTEE) and iAVAPlani(3DTEE) resulted in a reduction in the discordance of AS grading. A moderate correlation was observed between mPGcath and iAVACE(3DTEE) (BAV, r = −0.63; TAV, r = −0.68), with iAVACE(3DTEE) corresponding to the current guidelines' cutoff value (BAV, 0.58 cm2/m2; TAV, 0.60 cm2/m2). Discordance/concordance between iAVA and mPGcath in evaluating AS severity varies depending on the methodology and imaging modality used. The use of iAVACE(3DTEE) is valuable for reconciling the discordant AS grading in BAV patients as well as TAV.

Long-term durability of bioprosthetic aortic valve replacement in young patients with bicuspid aortic stenosis

ObjectiveTo examine long-term surgical aortic valve replacement (SAVR) outcomes for young (ie, younger than age 65 years) patients with bicuspid aortic valve and aortic stenosis (AS) with or without concomitant aneurysm. BackgroundThere are few studies evaluating the early and late outcomes of SAVR in young patients (younger than age 65 years) with bicuspid aortic valve and AS. MethodsUsing institutional data from 2004 through 2022, 498 patients with bicuspid aortic valve younger than age 65 years underwent SAVR for AS with bioprosthetic valves. We examined operative outcomes, long-term valve durability, and reintervention. ResultsThe total cohort comprised 281 patients undergoing isolated SAVR and 217 with concomitant aneurysm repair (SAVR/aneurysm). The average age was 55 ± 8 years, with Society of Thoracic Surgeons predicted risk of mortality score of median 0.7 (IQR 0.5, 1.0) and mean valve size of 25 mm. Operative mortality (0.7% vs 1.4%; P = .77) was similar between SAVR and SAVR/aneurysm patients. Predischarge permanent pacemaker implantation occurred in 1.6% (8 out of 498) patients. During overall follow-up of 5.0 years (IQR 1.8-9.9; range, 0.2-18.2 years), the cumulative incidence of reintervention at 10 years for structural valve degeneration (n = 33), including valve-in-valve (n = 15) was 6.6% (8.1% SAVR vs 4.5% SAVR/aneurysm; P = .66). No mortality was observed for valve-in-valve or redo-SAVR. Moderate or greater aortic regurgitation and paravalvular leak were observed in 6.5% and 0.3%, respectively, at most recent follow-up. ConclusionsBicuspid AS is common in patients younger than 65 years and management includes consideration of future valve intervention. SAVR confers excellent operative and reoperative outcomes, 10-year durability, and valve function. These results may support initial SAVR when considering lifetime management of AS.

Commentator Discussion: Long-term durability of bioprosthetic aortic valve replacement in young patients with bicuspid aortic stenosis

Commentator Discussion: Long-term durability of bioprosthetic aortic valve replacement in young patients with bicuspid aortic stenosis

Sex differences in transcatheter aortic valve replacement outcomes among patients with bicuspid aortic stenosis

BackgroundDespite comprising almost half of all patients undergoing valvular repair, data on transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic stenosis (BAS) are limited. ObjectiveWe aimed to evaluate whether there are any sex differences in trends and outcomes of TAVR in this population. MethodsWe utilized the National Inpatient Sample from 2012 to 2020 to identify admissions with BAS who underwent TAVR and analyzed trends and outcomes. Our primary outcome was in-hospital mortality and secondary outcomes were in-hospital complications. We used two models to adjust for demographics (A) and interventions (B). ResultsBetween 2012 to 2020, there were 76,540 hospitalizations for BAS patients who underwent AVR, among which 6,010 (7.9 %) underwent TAVR. There was an overall increasing trend in number of TAVR cases with a decreasing trend in mortality (2013: 8.7 %, 2020: 1.3 %). TAVR was performed more in males (61.1% vs 38.9 %). Despite the worse baseline characteristics in males, in-hospital mortality (2.4% vs. 1.5 %; OR: 1.584; 95 % CI: 0.621–4.038; p = 0.335) and secondary outcomes were similar across both sexes, even after adjusting for demographics and interventions. ConclusionTAVR in BAS has grown rapidly in the last decade. Males comprised the majority and had more comorbidities, but mortality and complications were similar in both sexes. Despite the increasing number of cases, a decreasing trend in mortality was observed for both sexes ultimately approaching that of SAVR, suggesting that TAVR may be a safe alternative among eligible males and females with bicuspid AS.

Transcatheter aortic valve implantation in low-risk tricuspid or bicuspid aortic stenosis: the NOTION-2 trial.

Transcatheter aortic valve implantation (TAVI) has become the first choice to treat older patients with severe symptomatic aortic stenosis (AS). This study aimed to compare TAVI with surgery in low-risk patients ≤75 years of age, including both tricuspid and bicuspid AS. The Nordic Aortic Valve Intervention (NOTION)-2 trial enrolled and 1:1 randomized low-risk patients aged ≤75 years with severe symptomatic AS to TAVI or surgery. The primary endpoint was a composite of all-cause mortality, stroke, or rehospitalization (related to the procedure, valve, or heart failure) at 12 months. A total of 370 patients were enrolled with a mean age of 71.1 years and a median Society of Thoracic Surgeons risk score of 1.1%. A total of 100 patients had bicuspid AS. The 1-year incidence of the primary endpoint was 10.2% in the TAVI group and 7.1% in the surgery group [absolute risk difference 3.1%; 95% confidence interval (CI), -2.7% to 8.8%; hazard ratio (HR) 1.4; 95% CI, 0.7-2.9; P = .3]. Patients with TAVI, when compared to surgery, had lower risk of major bleeding and new-onset atrial fibrillation and higher risk of non-disabling stroke, permanent pacemaker implantation, and moderate or greater paravalvular regurgitation. The risk of the primary composite endpoint was 8.7% and 8.3% in patients with tricuspid AS (HR 1.0; 95% CI, 0.5-2.3) and 14.3% and 3.9% in patients with bicuspid AS (HR 3.8; 95% CI, 0.8-18.5) treated with TAVI or surgery, respectively (P for interaction = .1). Among low-risk patients aged ≤75 years with severe symptomatic AS, the rate of the composite of death, stroke, or rehospitalization at 1 year was similar between TAVI and surgery. Transcatheter aortic valve implantation outcomes in young bicuspid AS patients warrant caution and should be further investigated. (NOTION-2, ClinicalTrials.gov, NCT02825134). ClinicalTrials.gov NCT02825134.

Comparison of downsizing strategy (HANGZHOU Solution) and standard annulus sizing strategy in type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement: Rationale and design of a randomized clinical trial

BackgroundThere has not been a consensus on the prothesis sizing strategy in type 0 bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR). Modifications to standard annular sizing strategies might be required due to the distinct anatomical characteristics. We have devised a Down Sizing Strategy for TAVR using a self-expanding valve specifically for patients with type 0 bicuspid AS. The primary aim of this study is to compare the safety and efficacy of Down Sizing Strategy with the Standard Annulus Sizing Strategy in TAVR for patients with type 0 bicuspid AS. Trial designIt is a prospective, multi-center, superiority, single-blinded, randomized controlled trial comparing the Down Sizing and Standard Annulus Sizing Strategy in patients with type 0 bicuspid aortic stenosis undergoing transcatheter aortic valve replacement. Eligible participants will include patients with severe type 0 bicuspid AS, as defined by criteria such as mean gradient across aortic valve ≥40 mmHg, peak aortic jet velocity ≥4.0 m/s, aortic valve area (AVA) ≤1.0 cm², or AVA index ≤0.6 cm2/m2. These patients will be randomly assigned, in a 1:1 ratio, to either the Down Sizing Strategy group or the Standard Sizing Strategy group. In the Down Sizing Strategy group, a valve one size smaller will be implanted if the “waist sign” manifests along with less than mild regurgitation during balloon pre-dilatation. The primary end point of the study is a composite of VARC-3 defined device success, absence of both permanent pacemaker implantation due to high-degree atrioventricular block and new-onset complete left bundle branch block. ConclusionThis study will compare the safety and efficacy of Down Sizing Strategy with the Standard Annulus Sizing Strategy and provide valuable insights into the optimal approach for sizing in TAVR patients with type 0 bicuspid AS. We hypothesize that the Down Sizing Strategy will demonstrate superiority when compared to the Standard Annulus Sizing Strategy. (Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0) (TAILOR-TAVR), NCT05511792)

E-40 | Transcatheter Aortic Valve Replacement versus Surgical Aortic Valve Replacement in Patients with Bicuspid Aortic Stenosis: A Propensity Score Matching Analysis

E-40 | Transcatheter Aortic Valve Replacement versus Surgical Aortic Valve Replacement in Patients with Bicuspid Aortic Stenosis: A Propensity Score Matching Analysis

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

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