Bicuspid Aortic Valve Research Articles

Creation of bicuspid aortic valve for bicuspid annulus using Ozaki’s neocuspidization technique, with indigenously developed valve templates

Creation of bicuspid aortic valve for bicuspid annulus using Ozaki’s neocuspidization technique, with indigenously developed valve templates

Abstract 4123806: Early Findings on the Impact of Renin-Angiotensin-Aldosterone System Inhibitors on Bicuspid Aortic Valve Disease Progression: A Single Center Cohort Study

Introduction: Patients with a bicuspid aortic valve (BAV) often have an associated aortopathy, increasing their risk of aortic dissection. Currently, there is no proven therapy to stabilize the growth of BAV aortopathy. This study aimed to assess the effect of cardioprotective medications, specifically renin-angiotensin-aldosterone system inhibitors (RAASi), on the progression of aortic dilation in adult BAV patients. Methods: A retrospective cohort study was conducted including adult patients with BAV followed at our center between 1996-2020. All patients had echocardiography imaging with at least 5 years of follow-up. The cohort was divided based on the chronic use of RAASi, as determined by pharmacy check-out data. The primary endpoint was defined as either the progression of ascending aortic diameter ≥ 4.5 cm or surgery for ascending aortic replacement. Results: The study included 262 patients with a mean age of 54.3±19.5 years, of whom 75.2% (n=197) were male, and 34.7% (n=44) had a diagnosis of hypertension. At baseline, the average size of the ascending aorta was 4.2±4.1 mm and 3.5±4.0 mm at the level of the aortic sinuses. The average follow-up time was 5.8±0.8 years. During follow-up, 23 patients underwent ascending aortic replacement with concurrent aortic valve replacement, 66 patients experienced progression of ascending aortic diameter ≥ 4.5 cm, and 2 patients died. Patients using RAASi (n=40) had a lower incidence of the primary endpoint compared to those without RAASi chronic therapy (12.8% vs. 24.8%, p=0.147). Multivariate analysis indicated that patients without RAASi chronic therapy had a significantly increased risk of the primary endpoint (HR=2.87, 95% CI [1.03-8.01], p=0.43). Conclusions: Our early findings suggest that RAASi may have a preventative role in the progression of BAV aortopathy.

Abstract 4136604: Efficacy of angiotensin receptor blockers in thoracic aortic aneurysm: meta-analysis of randomized controlled trials

Background: Thoracic aortic aneurysm (TAA) poses a significant risk of aortic dissection and mortality. Angiotensin receptor blockers (ARBs) have been proposed as a potential therapeutic intervention to mitigate these risks but their effects are uncertain. Aim: To evaluate the efficacy of ARBs in patients with TAA. Methods: A comprehensive search of Cochrane CENTRAL, Ovid Medline R, Pubmed, and Web of Science yielded 2563 records, from which 8 unique randomized controlled trials (RCTs) (including 7 Marfan and 1 bicuspid aortic valve+TAA populations) comprising 1575 patients were included in the analysis. The primary outcome measures were aortic dissection and all-cause mortality. Pooled risk ratios (RR) or mean differences (MD) in an inverse variance random-effects model were generated and analyses were performed with “meta” package in R (version 4.3.2). Results: Our analysis reveals no significant beneficial effect of ARBs on aortic dissection (RR 0,62 [95%CI, 0,20; 1,92], I 2 :0%) and all-cause mortality (RR 0,61 [95%CI, 0,18; 2,05], I 2 :0%), irrespective of specific ARB agents (including losartan, irbesartan, and telmisartan), comparators (beta blocker, placebo, or no treatment), disease condition (Marfan syndrome or bicuspid aortic valve), and patient demographics (children or adults). Additionally, there were no significant differences observed between ARB and control groups in changes in ascending aorta and aortic annulus diameter, as well as aortic Z-score at the 3-year mark, including the annual change in ascending aorta (MD 0.04 mm/year [95% CI, -0.07 to 0.15], I 2 :0%) and aortic root diameter (MD -0.06 mm/year [95% CI, -0.22 to 0.10], I 2 :81%) by echocardiography. However, there was a significant reduction in aortic root diameter as assessed by MRI (MD -0.48 mm/year [95%CI, -0.89 to -0.08]) and echocardiography (MD -0.51 mm/3year [95%CI, -0.85 to -0.17]), with low heterogeneity when compared with control. Risk of aortic surgery and severe adverse events were also comparable. Conclusion: We found no significant beneficial effect of ARBs in reducing the risk of aortic dissection or all-cause mortality in patients with TAA. Despite observing a significant reduction in the aortic root diameter by MRI and echocardiography with ARB therapy, other imaging outcomes were comparable between ARB and control groups.

Abstract 4141445: Long-Term Predictive Value of 4D Flow MRI in Bicuspid Aortic Valve Patients: A 10-Year Assessment for Aortic Surgery Risk

Introduction: Bicuspid aortic valve (BAV) is associated with progressive ascending aorta (AAo) dilation, often leading to aneurysms, dissections, and ruptures. Thus, current guidelines recommend preventive surgery for AAo dilation. Recent 4D flow MRI studies show that BAV morphology causes abnormal transvalvular flow patterns, increasing wall shear stress (WSS), a trigger of aortic growth. Further studies have delineated areas of abnormally high WSS by comparing to estimates of matched controls, and show promise in detecting risk for aortic growth. However, since the long-term prognostic significance of this marker is unclear, we aimed to quantify WSS in BAV patients to assess its value in predicting the need for aortic surgery up to 10 years post-4D flow MRI acquisition. Methods: BAV patients without prior surgical intervention scanned before April 1, 2014 were identified. Using medical records, patients were categorized as ‘operated’ if they underwent aortic surgery post-scan and ‘non-operated’ if they were surgery-free for at least 10 years post-scan. 4D flow MRIs were processed with an AI pipeline, including 3D segmentation of the aorta, followed by peak velocity (PV) and WSS quantification in the AAo (Fig. 1A-C). Patient-specific WSS heatmaps were computed relative to a map based on the WSS of 10 or more sex and age-matched controls. Relative areas of elevated WSS in the AAo were then calculated (Fig. 1D-F). Results: 115 patients were included, with 73 non-operated (age: 42.5±11.5y, 49M) and 42 operated patients (age: 53.5±12.1y, 34M). The mean baseline mid-AAo diameters for non-operated and operated patients were 3.8±0.6 cm and 4.1±0.5 cm, respectively. Among operated patients, the mean scan to surgery time was 5.7±3.3y. All three 4D flow metrics were significantly higher in operated compared to non-operated patients: PV: 2.6±0.6 vs. 1.7±0.4 m/s (p<0.01); WSS: 2.2±0.5 vs. 1.6±0.4 Pa (p<0.01); relative area of high WSS on heatmaps: 31±12 vs. 15±13% (p<0.01). Conclusions: 4D flow MRI parameters provide long-term predictive value in BAV patients, as elevated peak velocity, wall shear stress, and relative area of high wall shear stress on heatmaps are associated with subsequent aortic surgery within 10 years post-scan.

Abstract 4144548: High Morbidity and Mortality in Adults With Turner Syndrome and Aortic Dilation: A Retrospective Cohort Study from the Healthy Heart Project

Introduction: Turner syndrome (TS) is caused by the partial or complete absence of one sex chromosome and affects 1 in 2500 liveborn infants. Hypertension, bicuspid aortic valve (BAV), and thoracic aortic aneurysms (TAAs) are more prevalent in TS compared to the general population and predispose to aortic dissections, which may occur in young adults with TS. We hypothesize that adults with TS who have TAAs experience a high rate of adverse cardiovascular outcomes. Methods: Adults with TS who had Healthy Heart Project (HHP) echocardiograms at national conferences between 2003 and 2023 were contacted for enrollment in descending order of the aortic size index (ASI, cm/m 2 ), defined as the ratio of the maximum ascending aortic diameter to body surface area. After informed consent, clinical characteristics and outcomes (as numbers of participants or median and interquartile range) were abstracted from questionnaires and medical records. Results: Sixty-four of 704 total HHP participants were contacted and 19 (with 10 of the 20 highest ASI values) were enrolled with complete data. The baseline ASI was 2.19 (0.48), compared to 1.51 (0.36) for all other HHP participants. The median age was 59 (13) years. The most prevalent characteristics were 45,X (10) or 45,X/46,XX (6) karyotypes; BAV (9), coarctation (4), or no congenital lesions (6); and hypertension (12). A mean of 10 serial aortic images were available for each participant over a follow up period of 14 (9.8) years. The median increase in aortic diameter was 0.09 (0.29) mm/yr at the sinuses of Valsalva and 0.26 (0.44) mm/yr at the ascending aorta. Seven participants underwent aortic operations due to enlarging TAAs when the median ascending diameter was 3.83 (0.67) cm (ASI 2.58 (0.11) cm/m 2 ). In 3 cases, operations were urgent due to cardiovascular symptoms or rapid aortic dilation, but there were no acute aortic dissections. The median time between the index image and subsequent repair was 3.5 (7.0) years. Three HHP participants with the 8th, 15th, and 42nd largest ASI values died prior to follow up. One death was caused by complications after surgical aortic valve replacement at age 20. Conclusions: In a cohort of adults with TS and TAAs, 40% (7/19) developed progressive aortic enlargement requiring aortic repairs and there were 3 deaths. These observations underscore the importance of lifelong surveillance and timely intervention to prevent deaths due to cardiovascular disease in TS.

Abstract 4137145: Aortic Stenosis in Pregnancy: A Multidisciplinary Team Approach

Introduction: The hemodynamic adaptations that occur during pregnancy can have significant effects on patients with aortic stenosis (AS). These changes can lead to structural changes identified on echocardiogram even during uncomplicated pregnancies. While some cases can be managed with medical therapy and activity modification, others may require valve intervention in the gestational period. Case: A 29-year-old female with history of congenital bicuspid aortic valve, G1P0 presented at 42+2 weeks of pregnancy and was admitted to cardiac intensive care unit for continuous hemodynamic monitoring via use of arterial line. Her prior aortic valve disease was treated by valve repair with valvotomy, removal of tissue from pseudo raphe, removal of calcified scar tissue from both commissures, and a mitral valve repair for closure of an iatrogenic tear in her anterior leaflet. She followed closely with maternal fetal medicine and cardiology but became symptomatic at week 28 with lightheadedness, shortness of breath and decreased exercise tolerance (NYHA Class II). By week 33 she noticed lower extremity edema. Despite recommendations for planned delivery, she opted to wait until full term for delivery. Surveillance echoes revealed rising velocities yet stable valve area by planimetry. She ultimately underwent an uncomplicated Cesarean delivery of baby boy in week 42. At 6 months post partum she had successful transcatheter aortic valve replacement. Discussion: As the severity of valvular disease worsens there is a higher risk of complications during pregnancy. In our case, aortic valve velocities were elevated due to the expected hemodynamic changes of pregnancy. Thus, echocardiography monitoring should be used to assess the left ventricle’s ability to tolerate and compensate for these changes, while intervening based on symptoms and NYHA classification. We highlight the importance of multidisciplinary collaboration for safe and successful delivery in patients with AS.

Abstract 4112591: Delayed Migration of a Valve-in-Valve Transcatheter Aortic Valve Replacement

Introduction: Migration of a transcatheter aortic valve replacement (TAVR) is a rare, life-threatening complication that typically occurs during or shortly after the procedure. We present a unique case of an exceptionally rare, delayed migration of a valve-in-valve TAVR three years post-procedure that was subsequently treated with surgical explantation of the TAVR prosthesis and surgical aortic valve replacement (SAVR). Clinical Case: A 64-year-old male presented to an outpatient cardiology visit with one month of exertional dyspnea and near-syncopal episodes with a new diastolic murmur. Notable history included aortic regurgitation due to bicuspid aortic valve resulting in subcoronary implantation of a 27 mm Medtronic Freestyle stentless porcine bioprosthesis 20 years prior to presentation. Following the development of severe bioprosthetic regurgitation, a valve-in-valve TAVR with a 26 mm Edwards SAPIEN 3 Ultra was implanted 3 years prior to presentation with no evidence of stenosis or regurgitation on transthoracic echocardiograms completed 1 month and 1 year after implantation. Transesophageal echocardiogram now demonstrated migration of the TAVR valve into the left ventricular outflow tract 2 cm proximal to the surgical bioprosthesis. Severe eccentric transvalvular regurgitant flow through the surgical bioprosthesis and severe paravalvular regurgitation around the TAVR valve was seen with an unstable “rocking appearance”. No evidence of abscess or endocarditis was appreciated and blood cultures showed no growth. Following a short hospitalization, the patient underwent TAVR explantation and implantation of a 25 mm Edwards Inspiris Resilia stented bovine bioprosthesis with subsequent resolution of his symptoms. Discussion: Recognizing atypical presentations of TAVR complications such as delayed valve migration is facilitated by understanding key risk factors. This case highlights notable risk factors for TAVR migration including a valve-in-valve TAVR over a degenerative regurgitant bioprosthesis, decreased aortic annulus calcification resulting in suboptimal anchoring, the patient’s younger age, and the lack of a radiopaque marker on the stentless bioprosthesis which increases the potential for malpositioning.

Rare case of aorto-left atrial tunnel with associated bicuspid aortic valve, large patent ductus arteriosus, and atrial septal defects.

Aorto-cardiac tunnels represent uncommon cardiovascular anomalies connecting the ascending aorta to cardiac chambers and are typically characterized by extra-cardiac tubular channels. Among these, the involvement of the left atrium is exceptionally rare, with only a few cases reported in literature. Here, we describe a case of an aorto-left atrial tunnel in a 6-year-old boy with an associated bicuspid aortic valve, a large patent ductus arteriosus, and atrial septal defects. This case highlights the significance of multimodal imaging in the accurate identification and characterization of rare cardiovascular anomalies.

Aortic root reimplantation in patients with bicuspid and tricuspid aortic valve: a systematic review

Aortic root reimplantation in patients with bicuspid and tricuspid aortic valve: a systematic review

Recurrent Systemic Embolization From Bicuspid Aortic Valve Endocarditis in the Setting of Anti-coagulation Use

Recurrent Systemic Embolization From Bicuspid Aortic Valve Endocarditis in the Setting of Anti-coagulation Use

Acute coronary syndrome as the initial manifestation of infective endocarditis in an apparently normal native valve: a case report

Abstract Background Acute coronary syndrome (ACS) is a rare complication of infectious endocarditis (IE). We present the case of a patient with a bicuspid aortic valve who presented an acute ST elevation myocardial infarction (STEMI) of the inferior wall secondary to vegetation that generated obstruction of the ostium of the right coronary artery (RCA). Case summary A 54-year-old patient with only a history of smoking was admitted for chest pain. An acute ST elevation myocardial infarction (STEMI) in the inferior wall was documented; he underwent an emergent coronary angiography, which showed a mass that obstructed the ostium of the right coronary artery that did not allow its channeling. An angiotomography of the aorta was performed, where dissection was ruled out and the presence of a mass in the right coronary sinus that protruded towards the ostium of the coronary artery was confirmed. In the extension studies, a bicuspid aortic valve, thrombosis in the right brachial artery and in the infrarenal abdominal aorta were documented. Discussion The case was taken to a medical meeting and given the embolic and mechanical compromise; it was decided to perform surgery where a mass that invaded the proximal segment of the right coronary artery was resected. The histopathological study documented findings of vegetation; the cultures were positive for Staphylococcus epidermidis, and he finally received antibiotic and anticoagulation treatment.

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.

Echocardiographic Evaluation of Chronic Aortic Regurgitation: Comparison With Cardiac Magnetic Resonance and Implications for Guideline Recommendations.

Guidelines for echocardiographic evaluation of aortic regurgitation (AR) have not been validated against an independent quantitative standard. The aim of this study was to evaluate the accuracy of the ASE (American Society of Echocardiography) AR guidelines against cardiac magnetic resonance (CMR) and to develop simplified approaches for detection of significant AR. Patients with AR underwent echocardiography and CMR<4 hours apart. AR severity was graded according to ASE guidelines. Quantitation of regurgitant volume (RegV) was performed with pulsed Doppler at the mitral annulus and right ventricular outflow compared with left ventricular (LV) outflow, and with proximal isovelocity surface area. The authors studied 81 patients; median age was 52 years, and 58% had a bicuspid aortic valve. According to echo, 35 (43%) patients had mild AR, 18 (22%) moderate, 12 (15%) moderate to severe, and 16 (20%) had severe AR. The area under the curve (AUC) for detection of severe AR by CMR using ASE grading was 0.9 (82.4% sensitivity and 96.9% specificity). Feasibility of RegV quantitation was >88% using either echo volumetric method, and it was low for proximal isovelocity surface area (37%). The highest accuracy for echo parameters against CMR was seen with vena contracta width, jet width, and LV end-diastolic volume index (AUC: 0.86-0.89); pressure half-time had the lowest accuracy. Without RegV quantitation, a vena contracta width≥0.5cm and indexed LV end-diastolic volume≥82mL/m2 had 95.5% positive predictive value and 87.5% negative predictive value for identifying≥moderate to severe AR by CMR (AUC: 0.89). The ASE guidelines display very good performance in identifying significant AR. A simplified approach using vena contracta width and LV volumes can be used to reliably identify significant AR. Further validation of the findings in larger cohorts and against clinical outcomes is needed.

Stanford A aortic dissection 40 years after aortic valve replacement with a Starr–Edwards caged-ball prosthesis: a case report

Abstract Stanford A aortic dissection is one of the most devastating acute medical conditions due to its high morbidity and mortality. We describe a 77-year-old male patient with a medical history of surgical aortic valve replacement with a still functioning Starr–Edwards caged-ball valve 40 years prior. The patient was promptly diagnosed with an ascending aortic aneurysm and dissection, and an emergency Bentall procedure in deep hypothermic circulatory arrest was performed. This is, to the best of our knowledge, the first Stanford A dissection case described in the literature in a patient with Starr–Edwards valve, and the longest still functioning caged-ball valve to have been replaced with the Bentall procedure. We also discuss the caged-ball valve’s unfavorable hemodynamics as a potential predisposing factor of the dissection, as well as the patient’s supposed initial bicuspid aortic valve disease which could also predispose to aortic aneurysm formation and dissection.

Redo-TAVI feasibility and coronary accessibility following index TAVI with the Evolut valve in patients with bicuspid aortic valve stenosis

Redo-TAVI feasibility and coronary accessibility following index TAVI with the Evolut valve in patients with bicuspid aortic valve stenosis

Predicting new-onset persistent conduction disturbance following transcatheter aortic valve replacement: the usefulness of FEOPS finite element analysis

BackgroundDespite the frequency of persistent new-onset conduction disturbances after transcatheter aortic valve replacement (TAVR), few preoperative methods of prediction exist.MethodsPatients who underwent TAVR in the Department of Cardiology of the Second Affiliated Hospital of the Army Medical University from December 2020 to September 2021 and postoperative aortic root modeling via the FEOPS finite element analysis were included in this single-center case–control study, divided into persistent conduction disturbances (PCD) and non-PCD groups according to their pre- and postoperative electrocardiograms in the first month. Risk factors affecting PCD were identified by comparing the baseline data of these two groups, including echocardiograms, computed tomography angiography of the aortic root, surgical decision-making, and FEOPS data. Independent risk factors were screened using logistic regression modeling, and the receiver operating characteristic (ROC) curve was used to test the predictive ability.ResultsA total of 56 patients were included in this study, 37 with bicuspid aortic valve (BAV) and 19 with trileaflet aortic valve (TAV), with 17 cases of PCD. The contact pressure index (CPI) of FEOPS, valve oversize ratio, differences between membranous interventricular septum length and implantation depth (ΔMSID) and valve implantation depth were statistically different (P < 0.05). CPI could be used as an independent risk factor for PCD (P < 0.05), and the ROC curve comparison showed that the CPI was more predictive (AUC = 0.806, 95% CI: 0.684–0.928, P = 0.001).ConclusionsThe CPI of FEOPS has better predictive value for new-onset conduction disturbance after TAVR compared to other known predictors.

Ebstein's anomaly with coarctation of the aorta and a bicuspid aortic valve: a case report of a rare association with unique prenatal findings.

Ebstein's anomaly is rarely accompanied by coarctation of the aorta, although patients with Ebstein's anomaly have a relatively small left ventricle. Here, we report a rare case of Ebstein's anomaly with coarctation of the aorta and a bicuspid aortic valve. We compared the foetal echocardiographic parameters of five previous cases with Ebstein's anomaly without left heart obstruction to explore the association between left ventricular volume, Ebstein's anomaly severity, and left heart obstruction.

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.

Long-Term Durability of Transcatheter Aortic Valve Prostheses in Patients With Bicuspid Versus Tricuspid Aortic Valve.

Currently, there is a lack of evidence for the long-term bioprosthetic valve durability of patients with bicuspid aortic valve (BAV) following transcatheter aortic valve replacement (TAVR). This study aimed to evaluate hemodynamic outcome, structural valve deterioration, and bioprosthetic valve failure during long-term follow-up after TAVR in patients with BAV versus patients with tricuspid aortic valve (TAV). Patients with BAV and TAV who underwent TAVR between 2012 and 2020, with echocardiography followed for at least 3 years, were included. Baseline characteristics, long-term valve hemodynamic performance, structural valve deterioration, and bioprosthetic valve failure were compared between patients with BAV and TAV. A total of 170 patients with BAV and 145 patients with TAV were included. The mean duration of follow-up for patients with BAV and TAV was 5.2±1.8 and 5.0±1.7 years. No significant differences were observed in the rates of structural valve deterioration and bioprosthetic valve failure between patients with BAV and TAV: structural valve deterioration, BAV 20 (11.8%) versus TAV 16 (11.0%) at last follow-up (P=0.861); bioprosthetic valve failure, BAV 3 (1.8%) versus TAV 7 (4.8%) at last follow-up (P=0.196). More than moderate intravalvular aortic regurgitation (1.8% versus 4.8%, P=0.196) and paravalvular leak (6.5% versus 3.4%, P=0.305) were rare in both patients with BAV and patients with TAV. This study indicated satisfactory long-term valve durability of TAVR in patients with BAV. Comparable hemodynamic outcome, structural valve deterioration, and bioprosthetic valve failure could be achieved in patients with BAV and TAV during long-term follow-up after TAVR.

Cerebral Embolic Protection by Geographic Region

Transcatheter aortic valve replacement (TAVR) is an established treatment option for many patients with severe symptomatic aortic stenosis; however, debris dislodged during the procedure can cause embolic stroke. The Sentinel cerebral embolic protection (CEP) device is approved for capture and removal of embolic material during TAVR but its efficacy has been debated. To explore regional differences in the association of CEP utilization with stroke outcomes in patients undergoing TAVR. This post hoc analysis of a prospective, postmarket, randomized clinical trial evaluating TAVR performed with or without the CEP took place at 51 hospitals in the US, Europe, and Australia from February 2020 to January 2022. Patients with symptomatic aortic stenosis treated with transfemoral TAVR were included. Randomization was stratified according to center, operative risk, and intended TAVR valve type. Patients were excluded if the left common carotid or brachiocephalic artery had greater than 70% stenosis or if the anatomy precluded placement of the CEP device. Data for this post hoc study were analyzed from August to October 2024. TAVR with or without CEP. The primary end point was the rate of all stroke events at hospital discharge or 72 hours post-TAVR, whichever came first. Neurological examinations were performed at baseline and postprocedure to identify stroke, disabling stroke, and other neurological outcomes. The Stroke Protection With Sentinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR) trial enrolled and randomized 3000 patients (1803 [60.1%] male; mean [SD] age, 78.9 [7.8] years): 1833 in the US cohort (TAVR alone: 919, TAVR with CEP: 914) and 1167 patients in the outside the US (OUS) cohort (TAVR alone: 580, TAVR with CEP: 587). Patients in the US cohort were younger, more predominantly male, had a lower prevalence of atrial fibrillation, and had a higher prevalence of bicuspid aortic valve, diabetes, and peripheral vascular disease compared with the OUS cohort. In the main trial, the incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group, and there was no interaction by geographic region. In this post hoc analysis, patients treated with CEP in the US cohort exhibited a 50% relative risk reduction for overall stroke and a 73% relative risk reduction for disabling stroke compared to TAVR alone; a treatment effect on stroke risk reduction was not observed in the OUS cohort. The PROTECTED TAVR trial could not show that the use of CEP had a significant effect on the incidence of periprocedural stroke during TAVR. Although there was no significant interaction by geographic region, this exploratory post hoc analysis suggests a trend toward greater stroke reduction in the US cohort but not in the OUS cohort. These findings are hypothesis generating, and further research is needed to determine if regional differences in patient characteristics or procedural practices affect CEP efficacy. ClinicalTrials.gov Identifier: NCT04149535.