Bicuspid Aortic Valve Stenosis Research Articles

TAVR with self- expandable valves: what challenges in bicuspid aortic valve disease?

Background: The bicuspid aortic valve (BAV) represents a complex anatomic entity for transcatheter aortic valve replacement (TAVR) because of its unique technical challenges. All the randomized clinical trials comparing outcomes of TAVI with surgery till date, have excluded patients with bicuspid aortic valve. The only data in literature come from empirical observations, with large variability in implantation techniques across different centers and operators. Objective: These case reports describe the results of transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve stenosis (BAV) using self-expandable valves with their clinical, imaging, procedural, and follow-up settings. Case reports: We report 3 cases of TAVR with BAV. The patients were at high risk of surgery. Baseline cardiac computed tomography (CT) was analyzed by interventional cardiologists. We used self-expandable valves in all the procedures. There were no cases of valve embolization or need for a second valve, no post-dilatation, no cases of moderate or severe aortic regurgitation, and none of the cases required a permanent pacemaker implantation. Conclusion: With the available observational data, it seems that TAVI is indeed technically feasible in selected BAV patients with acceptable results. Self-expandable valves can be safe and effective devices for these procedures. Most of the current data studies highlight the importance of preprocedural imaging determining the outcome of TAVI in BAV patients. Advancements device iterations and procedural refinements will continue to improve the outcomes of these patients treated by TAVR.

Progression of the ascending aorta diameter after surgical or transcatheter bicuspid aortic valve replacement.

Ascending aorta dilatation in patients with bicuspid aortic valve is related both to genetic and haemodynamic factors. Aim of this study is to compare late progression of ascending aorta dilatation in bicuspid aortic valve patients undergoing surgical aortic valve replacement (SAVR) vs transcatheter aortic valve implantation (TAVI). Data of 189 consecutive patients who underwent aortic valve replacement for severe bicuspid aortic valve stenosis were prospectively collected. Patients who underwent SAVR were compared to patients who underwent TAVI. Indication to the procedure was validated by the institutional Heart Team. Aortic diameters were evaluated by transthoracic echocardiogram. Differences between preoperative and long-term follow-up ascending aorta diameters were compared in the two groups. Between January 2015 and December 2021, 143(76%) patients underwent SAVR and 46(24%) patients underwent TAVI. At 4.6 (Standard Deviation, SD 1.7) years follow-up, patients in the TAVI group showed significantly lower survival (P = 0.00013) and event-free survival (P < 0.0001). Ascending aorta diameter progression was lower in surgical compared to transcatheter patients, 0.95(0.60,1.30) mm vs 1.65(0.67, 2.63) mm, P = 0.02. Ascending aorta diameter progression indexed for body surface area and height, was lower in the surgical group: 0.72(0.38,1.05) mm/m2 vs 1.05(0.39,1.71) mm/m2 P = 0.02, and 0.59(0.36,0.81) mm/m vs 1.11(0.44,1.78) mm/m, P = 0.001, respectively. At multivariable linear regression analysis transcatheter procedure, baseline aortic diameter, and paravalvular leak were significantly associated with increased postoperative ascending aorta dilatation. Bicuspid aortic valve patients who underwent SAVR, showed significantly less long-term ascending aorta diameter progression than patients who underwent transcatheter procedure.

3D Characterization of the Aortic Valve and Aortic Arch in Bicuspid Aortic Valve Patients.

Patients with bicuspid aortic valve (BAV) commonly have associated aortic stenosis and aortopathy. The geometry of the aortic arch and BAV is not well defined quantitatively, which makes clinical classifications subjective or reliant on limited 2D measurements. The goal of this study was to characterize the 3D geometry of the aortic arch and BAV using objective and quantitative techniques. Pre-TAVR computed tomography angiogram (CTA) in patients with BAV and aortic stenosis (AS)were analyzed (n = 59) by assessing valve commissural angle, presence of a fused region, percent of fusion, and calcium volume. The ascending aorta and aortic arch were reconstructed from patient-specific imaging segmentation to generate a centerline and calculate maximum curvature and maximum area change for the ascending aorta and the descending aorta. Aortic valve commissural angle signified a bimodal distribution suggesting tricuspid-like (≤150°, 52.5% of patients) and bicuspid-like (>150°, 47.5%) morphologies. Tricuspid like was further classified by partial (10.2%) or full (42.4%) fusion, and bicuspid like was further classified into valves with fused region (27.1%) or no fused region (20.3%). Qualitatively, the aortic arch was found to have complex patient-specific variations in its 3D shape with some showing extreme diameter changes and kinks. Quantitatively, subgroups were established using maximum curvature threshold of 0.04 and maximum area change of 30% independently for the ascending and descending aorta. These findings provide insight into the geometric structure of the aortic valve and aortic arch in patients presenting with BAV and AS where 3D characterization allows for quantitative classification of these complex anatomic structures.

Long-term outcomes in patients with bicuspid valve stenosis and aortic dilation undergoing transcatheter valve implantation

BackgroundTo date, whether ascending aorta dilation (AAD) should be considered a contraindication for transcatheter aortic valve replacement (TAVR) remains a topic of debate.. ObjectiveThe study investigated the clinical outcome of TAVR in patients with bicuspid aortic valve stenosis (BAV-AS) complicated by AAD. MethodsWe included patients with BAV-AS who underwent TAVR between 2012 and 2019. We collected patient perioperative clinical data., tracked clinical outcomes for over four years post-TAVR, and obtained echocardiography images one year postoperatively. The Kaplan-Meier method was employed for analyzing both unadjusted and adjusted survival data, which was compared using the log-rank test. COX regression and nomograms were used to assess the impact of AAD on post-TAVR clinical outcomes in patients with aortic stenosis (AS), with all-cause mortality as the primary clinical endpoint. ResultsA total of 111 BAV patients were included in this study. Long-term follow-up showed an increased mortality risk in patients with BAV-AAD (adjusted Kaplan–Meier analysis: P = .02/0.001). Cox correlation analysis indicated that age (OR = 1.137; P = .034), AAD (OR = 3.51; P = .038), and postoperative left ventricular pressure (LVSP) (OR: 0.959; P = .044) were predictive factors for mortality more than four years after TAVR in patients with BAV. The area under the curve of the Nomogram predicting long-term survival for the training set of patients based on the above metrics was 0.845 (95% CI: 0.696–0.994). Short-term cardiac ultrasound follow-up showed a more rapid rate of AA expansion (0.29 [0–0.34] vs. -1 [−3.3–1] mm/month, P = .001) and a smaller proportion of AA diameter reduction (7.1% vs. 53.7%, P = .001) in patients who died. ConclusionsPatients with BAV-AAD-AS treated with TAVR have an increased risk of long-term mortality, and clinical prediction models, including AAD age and postoperative LVSP, may predict long-term patient survival. Condensed abstractThe study investigated the clinical outcome of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (BAV-AS) complicated by ascending aorta dilation (AAD). Patients with BAV-AAD-AS treated with TAVR have an increased risk of long-term mortality. AAD, age and postoperative LVSP, may predict long-term patient survival. Short-term cardiac ultrasound follow-up showed a more rapid rate of AA expansion and a smaller proportion of AA diameter reduction in patients who died. A high postoperative AAD expansion rate may indicate an adverse clinical outcome. Surgery regimens for tolerable BAV-AADs and can be considered as a treatment option.

E-53 | In-Hospital Outcomes of Transcatheter Aortic Valve Replacement versus Surgical Aortic Valve Replacement in Bicuspid Aortic Valve Stenosis: A Propensity Matched Cohort

E-53 | In-Hospital Outcomes of Transcatheter Aortic Valve Replacement versus Surgical Aortic Valve Replacement in Bicuspid Aortic Valve Stenosis: A Propensity Matched Cohort

Right Coronary Artery Aneurysm Masquerading as a Pericardial Cyst: A Case Report

Coronary artery aneurysms (CAAs) or ectasias are dilatations of arterial segments, commonly detected as an incidental finding during angiography. The incidence of CAAs varies from 0.3% to 5.3%, mainly caused by atherosclerosis, though infections, inflammatory conditions, and connective tissue disorders can also contribute. Giant CAAs are rare with a reported prevalence of 0.02–0.2%. In our case, a 45-year-old female has been diagnosed with a giant aneurysm in the right coronary artery, which was initially misinterpreted as a pericardial cyst. In addition, she has a bicuspid aortic valve and severe aortic stenosis, hence advised for surgical management.

Three-year clinical outcomes after transcatheter aortic valve implantation in patients with bicuspid aortic disease: Comparison between self-expanding and balloon-expandable valves.

Bicuspid aortic valve (BAV) stenosis is a complex anatomical scenario for transcatheter aortic valve implantation (TAVI). Favorable short-term clinical outcomes have been reported with TAVI in this setting, but long-term data are scarce. We retrospectively included, in a single-center registry, patients with BAV stenosis who underwent TAVI before 2020. We compared patients treated with self-expanding valves (SEV) versus balloon-expandable valves (BEV). The primary endpoint was a composite of all-cause mortality, stroke and need for aortic valve (AV) reintervention at 3 years. Secondary endpoints included each component of the primary endpoint, cardiovascular mortality, permanent pacemaker implantation (PPI) rate, mean gradient and ≥moderate paravalvular leak (PVL) rate. A total of 150 consecutive patients (SEV = 83, BEV = 67) were included. No significant differences were reported between SEV and BEV groups for the primary composite endpoint (SEV 35.9% vs. BEV 32%, p = 0.66), neither for clinical secondary endpoints (all-cause mortality SEV 28.1% vs. BEV 28%, p = 0.988; cardiovascular mortality SEV 14.1% vs. BEV 20%, p = 0.399; stroke SEV 12.5% vs. BEV 6%, p = 0.342; need for AV reintervention SEV 0% vs. BEV 0%; PPI SEV 28.1% vs. BEV 24%, p = 0.620). A lower mean gradient persisted up to 3 years in the SEV group (SEV 8.8 ± 3.8 mmHg vs. BEV 10.7 ± 3.2 mmHg, p = 0.063), while no significant difference was found in the rate of ≥ moderate PVL (SEV 3/30 vs. BEV 0/25, p = 0.242). In this single center registry, we observed favorable 3-year clinical outcomes in nonselected BAV patients treated with different generation devices, without significant differences between patients receiving SEV or BEV.

Virtual reality to predict paravalvular leak in bicuspid severe aortic valve stenosis in transcatheter aortic valve implants.

Severe aortic stenosis (AS) in bicuspid aortic valves (BAV) is associated with an increased risk of paravalvular leak (PVL) after a transcatheter aortic valve replacement (TAVR). Virtual reality (VR) has been shown to be an effective tool in surgical training, but its utility in clinical practice has not been studied. Here we present the first study to evaluate the use of VR simulation in pre-procedure planning and prediction of PVL in TAVR in patients with severe BAV AS. Twenty-two patients with severe BAV AS undergoing TAVR between 2014 and 2018 at the University of Minnesota were included in the study. VR simulation of TAVR implants was performed and implants were analyzed for PVL. The primary endpoint was the percent circumference of valve malapposition in VR as compared to the severity of PVL on post-procedure echocardiography. The median age was 78.26 years (IQR 63.77-86.79) and 40.9% (n = 9) were female. Our VR model accurately predicted the presence and absence of PVL in all patients (17/17 and 5/5, respectively). The mean circumferential PVL was 3.73 % ± 7.71. The receiver operator characteristic curve showed an area under the curve of 0.83 (0.59-1.00, P = .03) for malapposition in the VR-TAVR simulated model. VR-TAVR implantation may predict PVL in severe BAV AS undergoing TAVR.

Congenital Mitral Stenosis: A Rare Case Report and Review of Literature

Congenital mitral valve stenosis is a rare and severe disease, usually associated with other heart defects. The appropriate intervention depends on the site and mechanism of valvular obstruction and the aim is to avoid or delay valve replacement since it is associated with significant morbidity and mortality. We report a case of a 2-month male infant with a typical, severe mitral valve stenosis, mild bicuspid aortic valve stenosis, small patent foramen ovale, severe pulmonary hypertension with florid pulmonary edema. Keywords: Congenital Mitral Stenosis, Bicuspid Aortic Valve Stenosis, Severe Pulmonary Hypertension, Patent Foramen Ovale, Transthoracic Echocardiography.

Mechanism of balloon burst during transcatheter aortic valve replacement pre-dilatation: Image observation and validation by finite element analysis

BackgroundBalloon burst during transcatheter aortic valve replacement (TAVR) is serious complication. This study pioneers a novel approach by combining image observation and computer simulation validation to unravel the mechanism of balloon burst in a patient with bicuspid aortic valve (BAV) stenosis. MethodA new computational model for balloon pre-dilatation was developed by incorporating the element failure criteria according to the Law of Laplace. The effects of calcification and aortic tissue material parameters, friction coefficients, balloon types and aortic anatomy classification were performed to validate and compare the expansion behavior and rupture mode of actual balloon. ResultsBalloon burst was dissected into three distinct stages based on observable morphological changes. The mechanism leading to the complete transverse burst of the non-compliant balloon initiated at the folding edges, where contacted with heavily calcified masses at the right coronary sinus, resulting in high maximum principal stress. Local sharp spiked calcifications facilitated rapid crack propagation. The elastic moduli of calcification significantly influenced balloon expansion behavior and crack morphology. The simulation case of the calcific elastic modulus was set at 12.6 MPa could closely mirror clinical appearance of expansion behavior and crack pattern. Furthermore, the case of semi-compliant balloons introduced an alternative rupture mechanism as pinhole rupture, driven by local sharp spiked calcifications. ConclusionsThe computational model of virtual balloons could effectively simulate balloon dilation behavior and burst mode during TAVR pre-dilation. Further research with a larger cohort is needed to investigate the balloon morphology during pre-dilation by using this method to guide prosthesis sizing for potential favorable outcomes.

Cerebral embolic protection in transcatheter aortic valve replacement with bicuspid aortic stenosis

Abstract Background In the PROTECTED-TAVR randomized controlled trial, use of cerebral embolic protection device (CEPD) during transcatheter aortic valve replacement (TAVR) did not reduce procedural stroke. It is, however, not clear whether certain high-risk subgroups like young patients with bicuspid aortic stenosis may derive benefit from CEPD. Purpose This study aimed to determine the effectiveness of CEPD in preventing cerebrovascular events during TAVR in patients with severe bicuspid aortic stenosis. Methods We retrospectively analyzed 3505 patients who underwent transfemoral TAVR at a single center between 2016-2020 and identified 257 patients with bicuspid aortic valve stenosis. Baseline demographic, clinical, and procedural characteristics were stratified by CEPD use. We performed Cox Proportional Hazards regression analysis to examine whether the use of CEPD in patients was associated with a lower rate of cerebrovascular events (stroke or transient ischemic attack) after adjusting for baseline characteristics. Results Among 257 patients receiving TAVR for bicuspid aortic stenosis, median age was 74.7 years (IQR 66.9 – 83.2 years) and 62.6% were men. There were no significant differences in the baseline demographic and clinical characteristics between patients with (n=94) and without CEPD (n=163) (Figure 1a). In univariate analysis, there was no significant difference in rates of stroke or transient ischemic attack in-hospital or at 30-days (Figure 1b). In adjusted analysis, CEPD use (HR 1.55 [95% CI, 0.1-3.8)] was not associated with a decreased rate of stroke or transient ischemic attack. Conclusion These findings indicate that CEPD use is not associated with lower rates of cerebrovascular events in patients with bicuspid aortic stenosis and add to the growing body of evidence that questions the utility of CEPD during TAVR.Baseline Characteristics

Abstract 17605: Multidisciplinary Team Approach in the Management of Pregnant Women With Complex Congenital Heart Disease: A Case Series

Introduction: Women with congenital heart disease (CHD) now live well into adulthood and consider pregnancy. A multidisciplinary team approach is crucial to the management of complex pregnant cardio-obstetrics patients. Here, we present a case series of three patients where careful team-based care resulted in successful delivery and without significant postpartum complications. Case series: Baseline patient characteristics and delivery details are summarized in Table 1. Patient 1, with history of repaired bicuspid aortic valve (AV) and subsequent severe bioprosthetic aortic stenosis, presented with incalcitrant supraventricular tachycardia leading to an urgent c-section. Patient 2, with history of complete Shone complex, underwent emergent c-section in the cardiac OR with extracorporeal membrane oxygenation on standby after developing rapid atrial tachycardia. Patient 3 fortunately did not suffer difficulties during her pre-planned c-section. She had a history of partial AV canal defect and subaortic membrane causing severe left ventricular outflow tract obstruction. Despite the differences between their hospitalizations and pregnancy course, utilizing a multidisciplinary approach led to no long-term postpartum complications and delivery of healthy neonates for all three patients. Discussion: Cardiovascular (CV) disease is the leading cause of maternal mortality accounting for greater than 25% of deaths. CHD is the most common CV condition encountered in pregnant women. Consistent with the Presidential Advisory from the AHA and ACOG, development of a cardio-obstetrics team is vital to managing complex maternal CV disease and minimizing CV morbidity and mortality. Conclusion: Integrating the expertise and collaboration among a multidisciplinary cardio-obstetrics team from preconception through the postpartum period allows for individualized care necessary to optimize maternal and fetal outcomes for women with complex CHD.

Abstract 14046: Cardiac Tamponade: A Handy Case of Early Detection

Case Presentation: A 63-year-old man with severe bicuspid aortic valve stenosis underwent surgical aortic valve replacement and the post operative echocardiogram was normal.In the month after discharge, the patient developed progressive episodes of lightheadedness, fatigue, and exertional weakness. He had no associated dyspnea on exertion, chest pain or fever. He was alerted of new sinus tachycardia on his Apple Watch, and the ECG morphology began changing with an overall decrease in QRS amplitude as well as alternating QRS amplitudes consistent with electrical alternans (Figure 1). These ECG strips were sent to the patient’s cardiologist who suspected a pericardial effusion due to these characteristic ECG findings.The patient underwent outpatient echocardiography which showed a normal functioning bioprosthetic valve with new large circumferential pericardial effusion and signs of cardiac tamponade physiology. The patient was admitted and underwent urgent pericardial drain placement with removal of 250cc of serosanguineous fluid. He recovered and was discharged with 3 months of colchicine. Discussion: Pericardial effusions are a known potential complication after cardiac surgery and often have an occult presentation making detection difficult. Smart watches with ECG capabilities provide valuable data because they can be used to detect the development of a new tachycardia and changes in QRS morphology. By observing the progressive changes in the QRS morphology from baseline, it is possible to monitor for the development of electrical alternans. This finding coupled with the patient’s clinical presentation prompted rapid evaluation and treatment. Conclusions: The Apple Watch can perform single-lead ECGs which are capable of diagnosing arrhythmias including atrial fibrillation. This case now opens the door to the early detection of postoperative pericardial effusions by monitoring the Apple watch for electrical alternans.

Impact of Pacemaker Implantation After Transcatheter Aortic Valve Replacement on Long-Term Survival in Patients With Bicuspid Aortic Valve

Limited data are available about the impact of permanent pacemaker (PPM) implantation on long term survival in patients with bicuspid aortic valve (BAV) and severe aortic stenosis (AS) treated with trans catheter aortic valve replacement (TAVR). We aimed to evaluate long-term clinical outcomes of BAV patients with AS who underwent peri-procedural PPM implantation after TAVR with self-expandable prosthesis. Data from patients with BAV and severe AS who underwent TAVR between April 2009 and January 2022 and followed in the framework of the One Hospital ClinicalService - CoreValve Project were collected. Patients were categorized in two groups according to PPM implantation after TAVR ("PPM" group") or not ("no PPM" group"). Co-primary endpoints were all-cause death and a composite of cardiac mortality, re-hospitalization due to cardiac causes, stroke and myocardial infarction. Overall, 106 patients were considered (74 in the "no PPM" group and 32 in the "PPM" group). No statistically significant difference was found between groups in terms of follow-up and baseline characteristics. Patients in the "PPM" group were more likely to show baseline conduction abnormalities (p=0.023). Patients in the "PPM" group were more often treated with older generation prosthesis as compared to those in the "no PPM" group (respectively 28.1% vs 5.4% p=0.013). At two-years follow-up, all-cause death in the "no PPM" and "PPM" groups occurred in 20.0 % and 10.0 % of patients, respectively [HR 0.37, 95% CI (0.08-1.67)]. Similarly, no difference was evident for the composite endpoint between the two groups ["no PPM" vs "PPM": 8 (14.6 %) vs 6 (19.3 %), HR 1.67, 95% CI (0.58-4.81)]. In conclusion, patients with severe AS and BAV treated with TAVR complicated by PPM implantation are not exposed to an increased risk of major adverse events at two years of follow-up.

Mid-term outcomes and hemodynamic performance of transcatheter aortic valve implantation in bicuspid aortic valve stenosis: Insights from the bicuSpid TAvi duraBILITY (STABILITY) registry.

Limited data are available on transcatheter heart valves (THVs) durability in bicuspid aortic valve (BAV) stenosis. To evaluate evaluating 4-year clinical and echocardiographic outcomes of patients with BAV undergoing transcatheter aortic valve implantation (TAVI). The bicuSpid TAvi duraBILITY (STABILITY) registry is an Italian multicentre registry including all consecutive patients with BAV and severe aortic stenosis (AS), treated by means of TAVI between January 2011 and December 2017. Outcomes of interest were all-cause death at 4-year, over time changes in echocardiographic measurements, and THV durability according to the valve aortic research consortium (VARC)-3 update definitions. Study population included 109 patients (50% females; mean age 78 ± 7.5 years) with a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.1 ± 4.3%. Median follow-up (FU) duration was 4.1 years [interquartile range: 2.8-5.1]. The overall cumulative incidence of all-cause death by Kaplan-Meier estimates at 4 years was 32%. Compared to baseline, a significant decrease in transprosthetic mean gradient was obtained after TAVI (54 ± 16 vs. 10 ± 5 mmHg; p < 0.001), whereas a significant increase was observed at 4-year (13 ± 6.4 mmHg, p = 0.03). Cumulative incidence of hemodynamic valve dysfunction (HVD) was 4%. Six patients met HVD criteria: three moderate and three severe HVD. All three cases of severe HVD were clinically relevant (bioprosthetic valve failure[BVF]) with two patients receiving a reintervention (TAVI in TAVI), and one patient experiencing a valve-related death due to endocarditis. The STABILITY registry suggests that in patients with severe AS and BAV undergoing TAVI, postprocedural clinical benefits might last, over time, up to 4-year FU. The low rates of severe HVD and BVF may support the hypothesis of good THV durability also in BAV recipient.

Results of new-generation balloon vs. self-expandable transcatheter heart valves for bicuspid aortic valve stenosis.

Data comparing new-generation self-expandable (SEV, Evolut R/PRO) vs. balloon-expandable (BEV, SAPIEN 3/3Ultra) transcatheter heart valve replacement (TAVR) in bicuspid aortic valve stenosis (BAV) is limited. Our aim was to compare 30-day results of SEV and BEV implantations in patients with BAV. A total of 2009 patients underwent TAVR between April 2015 and June 2021 at our Centre. From our institutional registry, we identified 106 consecutive patients with BAV who underwent TAVR using SEV and BEV. A 106 patients (n = 68 BEV; n = 38 SEV) were included. Mean age was 74.6 ± 8.8 years (BEV) vs.75.3 ± 8.7 years (SEV) (p = 0.670) and Society of Thoracic Surgeons score was 2.6 ± 1.9 (BEV) vs. 2.6 ± 1.6 (SEV) (p = 0.374), respectively. Device landing zone calcium volume (DLZ-CV) was 1168 ± 811 vs. 945 ± 850 mm3 (p = 0.192). Valve Academic Research Consortium (VARC)-3 device success at 30 days was similar (BEV 80.9% vs. SEV 86.8%; p = 0.433). More post-dilatations were performed in SEVs (23.5% BEV vs. 52.6% SEV; p = 0.002). Overall mean gradient at 30 days follow-up was 11.9 ± 4.6 mmHG (BEV) vs. 9.2 ± 3.0 mmHG (SEV) (p = 0.002). A mild-moderate degree of paravalvular leak (PVL) was detected more often in the SEV group (7.4% vs. 13.2%; p = 0.305). A trend towards higher rate of permanent pacemaker implantation was observed in SEV (11.8% vs. 23.7%; p = 0.109). Treatment of BAV revealed similar performance using BEV and SEV. In this retrospective cohort study, hemodynamics were more favorable with the SEV, although there was a trend toward more PVL and significantly more post-dilations.

Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry.

Prospective data about transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients are limited. We aimed to evaluate the clinical impact of the Evolut PRO and R (34 mm) self-expanding prostheses in BAV patients and explore the impact of different computed tomography (CT) sizing algorithms in aprospective registry. Atotal of 149 bicuspid patients were treated in 14 countries. The primary endpoint was the intended valve performance at 30 days. Secondary endpoints were 30-day and 1-year mortality, severe patient-prosthesis mismatch (PPM) and the ellipticity index at 30 days. All study endpoints were adjudicated according to Valve Academic Research Consortium 3 criteria. The mean Society of Thoracic Surgeons score was 2.6% (1.7-4.2) Type I L-R BAV was observed in 72.5% of the patients. Evolut valve sizes 29 and 34 mm were utilised in 49.0% and 36.9% of the cases, respectively. The 30-day cardiac death rate was 2.6%; the 1-year cardiac death rate was 11.0%. Valve performance at 30 days was observed in 142/149 (95.3%) patients. The mean aortic valve area post-TAVI was 2.1(1.8-2.6) cm2, and the mean aortic gradient was 7.2 (5.4-9.5) mmHg. No patient had more than moderate aortic regurgitation at 30 days. PPM was observed in 13/143 (9.1%) surviving patients and was severe in 2 patients (1.6%). Valve function was maintained at 1 year. The mean ellipticity index remained 1.3 (interquartile range 1.2-1.4). Overall, 30-day and 1-year clinical and echocardiography outcomes were similar between the two sizing strategies. BIVOLUTX demonstrated afavourable bioprosthetic valve performance and good clinical outcomes after TAVI with the Evolut platform in patients with bicuspid aortic stenosis. No impact from the sizing methodology could be identified.

Transcatheter Aortic Valve Replacement in Bicuspid Versus Tricuspid Aortic Valve Stenosis: Meta-Analysis and Systemic Review

Because of its anatomic and procedural complexities, bicuspid aortic valve (BAV) has been excluded from previous trials investigating transcatheter aortic valve replacement (TAVR). We aimed to compare the clinical outcomes of TAVR in BAV and tricuspid aortic valve patients. We searched the databases systematically from inception until March 2023 for studies that reported the outcomes of TAVR in BAV and tricuspid aortic valve patients. The primary focus was all-cause mortality at 1year. Additional outcomes included outcomes at 30-day follow-up. Secondary and subgroup analyses were performed on propensity-matched patients, patients at low surgical risk, and based on the type of transcatheter valve type. We included 30 studies with a total of 193,274 patients who underwent TAVR, of which 14,353 patients had BAV stenosis. The rate of 1-year mortality was lower in the BAV group compared with the tricuspid group with the results reaching statistical significance (odds ratio [OR] 0.86, 95% confidence interval [CI] 0.75 to 0.98, p=0.02). The rate of 30-day stroke, however, was higher in patients with BAV who underwent TAVR (OR 1.24, 95% CI 1.08 to 1.43, p<0.05). Other 30-day clinical outcomes were similar between the 2 groups. Similar outcomes were observed in secondary analysis of matched populations with less mortality and higher rate of stroke in patients with BAV (OR 0.84, 95% CI 0.72 to 0.96, p=0.01, and OR 1.38, 95% CI 1.09 to 1.75, p<0.05, respectively). Comparing the outcomes for self-expandable and balloon-expandable valves resulted in similar results. Subgroup analysis of low-surgical-risk patients similarly showed lower 1-year mortality in patients with BAV (OR 0.67, 95% CI 0.50 to 0.91, p=0.01), without difference in 30-day stroke between the 2 groups (OR 1.24, 95% CI 0.83 to 1.88, p=0.30). In conclusion, this report indicates that TAVR is safe and feasible in patients with BAV, including patients at low surgical risk. The higher rate of 30-day stroke, however, warrants caution when pursuing TAVR in this population. More studies, specifically randomized trials, are still warranted to further assess the safety and the long-term outcomes in this group.

Benchmarking Outcomes of Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valves

BackgroundThe relative roles for transcatheter and surgical aortic valve replacement (SAVR) for bicuspid aortic valve (AV) stenosis are debated. This study analyzes the 5-year longitudinal outcomes of isolated SAVR in bicuspid vs tricuspid AV patients, particularly in low-risk patients. MethodsAll patients undergoing isolated index SAVR at 1146 United States hospitals in The Society of Thoracic Surgeons (STS) Adult Cardiac database between July 1, 2011, and December 31, 2018, with linkage to Medicare claims, were analyzed. ResultsA total of 65,687 patients were analyzed, including of 9131 bicuspid patients (13.9%). Compared with tricuspid patients, bicuspid patients were significantly younger (median 70 vs 74 years, P < .001) with lower Society of Thoracic Surgeons predicted risk of mortality scores (mean 1.6% vs 2.3%, P < .001) and lower risk profile. Risk-adjusted 30-day mortality and major morbidity were similar, but risk-adjusted 5-year mortality was significantly lower in the bicuspid patients (adjusted hazard ratio, 0.72; 95% CI, 0.66-0.77), specifically in low-risk patients (adjusted hazard ratio, 0.69; 95% CI, 0.64-0.76). Additionally, the bicuspid cohort had a lower 5-year readmission risk of heart failure, stroke, bleeding, or other cardiovascular causes (all P < .05). ConclusionsIn this nationally representative study, 30-day mortality was similar, but risk-adjusted 5-year mortality was significantly lower in bicuspid patients undergoing isolated SAVR compared with tricuspid patients, specifically low-risk and normal left ventricular ejection fraction patients. This analysis provides a much-needed 5-year longitudinal national-level benchmark to better inform the discussion of transcatheter vs SAVR in bicuspid patients.

The first clinical data of the SAPIEN 3 aortic valve in the treatment of aortic stenosis in China.

Data on outcomes following transcatheter aortic valve replacement with SAPIEN 3 in China is limited as it was approved by the National Medical Products since 2020. The present study was designed to collect clinical data on the SAPIEN 3 aortic valve in Chinese patients with bicuspid aortic valve and tricuspid aortic valve stenosis. We analyzed the patient characteristics, procedural features and procedural outcomes of the first 438 patients (223 for bicuspid aortic valve and 215 tricuspid aortic valve) from 21 provinces in 74 sites treated with the SAPIEN 3 valve system for transcatheter aortic valve replacement between September 2020 and May 2022. Procedural mortality was 0.7%. 5 cases during the operation were converted to surgery. Among 438 cases, permanent pacemaker implantation was performed in a total of 12 cases (2.7%). The patient had severe leaflet calcification of the aortic valve, with moderate and severe calcification reaching 39.7% and 35.2% respectively. The size of the implanted valves was predominantly 26 mm and 23 mm, reaching 42.5% and 39.5% respectively. The incidence of moderate or severe perivalvular leak in the postoperative period was 0.5%, with a predominance of 90/10 and 80/20 valve deployment height. There was a significant difference in the deployment height of the valve between bicuspid aortic valve and tricuspid aortic valve, with the bicuspid aortic valve having a more deployment height of 90/10. Annulus size in bicuspid aortic valve group was significantly larger than tricuspid aortic valve group. Valve sizing for oversized, within size, and undersized were different between bicuspid aortic valve and tricuspid aortic valve. Procedural success rates were high, with similar and good results for bicuspid aortic valve and tricuspid aortic valve, low perivalvular leak for both valve types, and low permanent pacemaker implantation rates for both valve types. Annulus size, valve sizing and coronary artery height were significantly different in the BAV and TAV group.