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Background: 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)., Methods and Results: 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., Conclusions: 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.

Introduction: Decisions regarding the optimal timing of intervention for asymptomatic aortic stenosis (AS) are controversial. The study aims to identify potential risk factors for asymptomatic patients with severe AS that are associated with worse prognosis and to evaluate the benefits of early interventions for asymptomatic patients presenting with one or more additional risk factors., Methods and Analysis: This is a non-interventional, prospective, open-label, multicentre registry study across China. A total of 1000 patients will be enrolled and categorised as symptomatic or asymptomatic. The primary endpoint is the occurrence of all-cause mortality, stroke, acute myocardial infarction and heart failure-related hospitalisation at 1-year follow-up. In asymptomatic severe AS patients presenting with one or more risk factors, the occurrence rate of the primary endpoint between those who undergo transcatheter aortic valve replacement (TAVR) and those who do not will be compared. We will also compare the occurrence rate of the primary endpoint for asymptomatic severe AS patients with additional risk factors who undergo TAVR with those presenting with symptoms. This study is believed to provide additional evidence to help clinicians identify and refer severe AS patients who are asymptomatic but present with additional risk factors for early intervention of TAVR., Ethics and Dissemination: The study protocol has been approved by the local ethics committee of each participating site: West China Hospital, Sichuan University; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Second Hospital of Hebei Medical University; Tianjin Chest Hospital; and First Affiliated Hospital of Nanchang University. All participants will provide written informed consent. Study results will be published through academic conferences and peer-reviewed journals., Trial Registration: This study was registered at the Chinese Clinical Trial Registry (https:// www.chictr.org.cn), with the registration number ChiCTR2200064853., Competing Interests: Competing interests: Dr Chen and Feng are consultants and proctors for Venus MedTech, MicroPort and TaurusOne. All other authors have nothing relevant to disclosure., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Data concerning the outcomes of transcatheter aortic valve replacement in type 0 bicuspid aortic stenosis (AS) are scarce. The study aims to compare the outcomes of transcatheter aortic valve replacement for AS in patients with type 0 bicuspid, type 1 bicuspid, and tricuspid aortic valve anatomy., Methods: We enrolled consecutive patients undergoing transcatheter aortic valve replacement for severe AS between 2012 and 2022 in this single-center retrospective cohort study. The primary outcome was mortality, while secondary outcomes included in-hospital complications such as stroke and pacemaker implantation and transcatheter heart valve hemodynamic performance., Results: The number of patients with AS with type 0 bicuspid, type 1 bicuspid, and tricuspid aortic valve anatomy was 328, 302, and 642, respectively. Self-expanding transcatheter heart valves were used in the majority of patients (n=1160; 91.4%). In the matched population, differences in mortality (30 days: 4.2% versus 1.7% versus 1.7%, P overall =0.522; 1 year: 10% versus 2.3% versus 6.2%, P overall =0.099) and all stroke (30 days: 1.0% versus 0.9% versus 0.0%, P overall =0.765; 1 year: 1.4% versus 1.6% versus 1.3%, P overall =NS) were nonsignificant, and the incidence of overall in-hospital complications was comparable among groups. Ascending aortic diameter was the single predictor of 1-year mortality in type 0 bicuspid patients (hazard ratio, 1.59 [95% CI, 1.03-2.44]; P =0.035). The proportion of patients with a mean residual gradient ≥20 mm Hg was the highest in those with type 0 bicuspid anatomy, although the need for permanent pacemaker implantation was the lowest in this group., Conclusions: Major clinical outcomes of transcatheter aortic valve replacement for AS in patients with type 0 bicuspid, type 1 bicuspid, and tricuspid aortic valve anatomy are equivalent at short- and mid-term follow-up. These observations merit further exploration in prospective international registries and randomized controlled trials., Competing Interests: Disclosures M. Chen and Dr Feng are proctors/consultants of Venus MedTech, MicroPort, and Peijia Medical. Dr Mylotte is a proctor and consultant for Medtronic and Microport and a consultant for Boston Scientific. Dr Piazza is a consultant and proctor for Medtronic and Peijia Medical. Dr Prendergast has received institutional educational and research grants from Edwards Lifesciences and speaker/consultancy fees from Abbott, Anteris, Edwards Lifesciences, Medtronic, and Microport. The other authors report no conflicts.

Background: We aim to determine predictors of inadequate left ventricular mass index (LVMi) regression at mid-term after transcatheter aortic valve replacement (TAVR), including the potential role of epicardial adipose tissue (EAT)., Methods: We retrospectively reviewed patients with both echocardiographic assessments and multi-slice computed tomography (MSCT) obtained one year after TAVR. The change of LVMi, the volume and the average CT attenuation of EAT from baseline to one-year follow-up was calculated. Patients were divided into two groups by the percentage change of LVMi at a cut-off of 15%., Results: A total of 152 patients were included with a median age of 74 years (interquartile range [IQR] 69-78 years) and 56.6% being male. LVMi decreased (P < 0.0001) while EAT volume increased and the average CT attenuation decreased (both P < 0.0001) at one year. Baseline atrial fibrillation (P = 0.042), mitral regurgitation ≥ mild (P = 0.006), aortic regurgitation (AR) > mild (P = 0.001) and the change in the average CT attenuation of EAT (P = 0.026) were different between the decrease of LVMi ≥ 15% and < 15%. AR > mild at baseline was the only statistically significant predictor of a decrease of LVMi < 15% at one year (OR 0.33, 95% CI: 0.13 to 0.84, P = 0.021) in multivariate regression., Conclusions: Concomitant more-than-mild AR might predict better left ventricular reverse remodeling regression after TAVR., (© 2023. The Author(s).)

Indications for transcatheter aortic valve implantation (TAVI) have expanded in many countries to include patients with aortic stenosis who are at low surgical risk, and a similar expansion to this cohort is anticipated elsewhere in the world, together with an increase in the proportion of patients with bicuspid aortic valve (BAV) morphology as the age of the patients being treated decreases. To date, patients with BAV have been excluded from major randomized trials of TAVI owing to anatomical considerations. As a consequence, BAV has been a relative contraindication to the use of TAVI in international guidelines. Although clinical experience and observational data are accumulating, BAV presents numerous anatomical challenges for successful TAVI, despite advances in device design. Furthermore, in those with BAV, substantial geographical variation exists in patient characteristics, clinical approach and procedural strategy. Therefore, in this Roadmap article, we summarize the existing evidence and provide consensus recommendations from an international group of experts on the application of TAVI in patients with BAV in advance of the anticipated growth in the use of this procedure in this challenging cohort of patients., (© 2022. Springer Nature Limited.)

Background: It is unknown whether the sex difference whereby female transcatheter aortic valve replacement (TAVR) candidates had a lower risk profile, a higher incidence of in-hospital complications, but more favorable short- and long-term survival observed in tricuspid cohorts undergoing TAVR would persist in patients with bicuspid aortic valves (BAVs)., Objectives: The aim of this study was to reexamine the impact of sex on outcomes following TAVR in patients with BAVs., Methods: In this single-center study, patients with BAVs undergoing TAVR for severe aortic stenosis from 2012 to 2021 were retrospectively included. Baseline characteristics, aortic root anatomy, and in-hospital and 1-year valve hemodynamic status and survival were compared between sexes., Results: A total of 510 patients with BAVs were included. At baseline, women presented with fewer comorbidities. Men had a greater proportion of Sievers type 1 BAV, higher calcium volumes (549.2 ± 408.4 mm 3 vs 920.8 ± 654.3 mm 3 ; P < 0.001), and larger aortic root structures. Women experienced more vascular complications (12.9% vs 4.9%; P = 0.002) and bleeding (11.1% vs 5.3%; P = 0.019) and higher residual gradients (16.9 ± 7.7 mm Hg vs 13.2 ± 6.4 mm Hg; P < 0.001), while men were more likely to undergo second valve implantations during index TAVR (6.3% vs 15.9%; P = 0.001). Death at 1 year was not significantly different between sexes (HR: 1.15; 95% CI: 0.56-2.35; P = 0.70). Bleeding (adjusted HR: 4.62; 95% CI: 1.51-14.12; P = 0.007) was the single independent predictor of 1-year death for women., Conclusions: In patients with BAVs undergoing TAVR, women presented with fewer comorbidities, while men had a greater proportion of type 1 BAV, more calcification, and larger aortic roots. In-hospital outcomes favored men, with fewer complications except for the need for second valve implantation, but 1-year survival was comparable between sexes., Competing Interests: Funding Support and Author Disclosures This work was supported by the National Natural Science Foundation of China (grants 81970325, 82170375, and 82102129); Sichuan Province Department of Science and Technology (grant number 2022YFS0364); West China Hospital “1·3·5” Discipline of Excellence Project “Percutaneous Transcatheter Aortic Valve Implantation” and “Mechanisms of Aortic Stenosis and the Clinical Applications”; and a fellowship of the China Postdoctoral Science Foundation (2020M683327). Drs Mao Chen and Feng are proctors and consultants for Venus MedTech, MicroPort, and Peijia Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess cusp symmetry and coronary ostial eccentricity and its impact on coronary access following transcatheter aortic valve replacement (TAVR) using a patient-specific commissural alignment implantation technique., Background: TAVR implantation techniques to obtain neocommissural alignment have been introduced. The impact of cusp symmetry and coronary ostial eccentricity on coronary access after TAVR remains unknown., Methods: Cardiac computed tomographic scans from 200 tricuspid aortic valves (TAVs) and 200 type 1 bicuspid aortic valves (BAVs) were studied. Cusp symmetry and coronary ostial eccentricity were assessed. In addition, the right coronary cusp/left coronary cusp and right coronary artery (RCA)/left coronary artery (LCA) ostia overlap views were calculated and compared., Results: Severe cusp asymmetry (>135°) was more frequent in BAVs (52.5%) than in TAVs (2.5%) (P < 0.001), with the noncoronary cusp being the most common dominant cusp. The RCA ostium was found to be more often eccentric (>20°) than the LCA ostium (28% vs 6%, respectively; P < 0.001). Considering the right/left cusp overlap view, there was <20° deviation between the right coronary cusp-left coronary cusp centered line and the RCA-LCA centered line in 95% of all patients (TAV, 97%; BAV, 93%). The right/left cusp and coronary ostia overlap view differed by <10° and <20° fluoroscopic angulation in 75% and 98% of all cases, respectively., Conclusions: Using the right/left cusp overlap view to obtain commissural alignment in TAVR is also an effective approach to implant one of the transcatheter heart valve commissures in the near center between both coronary ostia in most TAVs and type 1 BAVs. Preprocedural CT assessment remains crucial to assess cusp symmetry and coronary ostial eccentricity., Competing Interests: Funding Support and Author Disclosures Dr De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Bieliauskas has received consulting fees from Abbott, Boston Scientific, and Medtronic. Dr Kofoed has received institutional grants from AP Møller og hustru Chastine McKinney Møllers Fond, the Meyer Foundation, the Danish Heart Foundation, the Danish Agency for Science, Technology, and Innovation by the Danish Council for Strategic Research, and Canon Medical. Dr Chen is the consultant for CardioFlow, Venus MedTech, and Peijia Medical. Dr Sondergaard has received institutional research grants and consulting fees from Abbott, Medtronic, Boston Scientific, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Optimal projection is essential for valve deployment during transcatheter aortic valve implantation (TAVI). The purpose of this study was to propose an approach to predict optimal projection in TAVI candidates with different aortic valve anatomies., Methods: 331 patients undergoing self-expanding TAVI were included and the so-called non-coronary cusp (NCC)-parallel technique was utilized, which generated the predicted projection by connecting NCC commissures on the transverse plane on the pre-procedural computed tomography images., Results: 37.8% of the study cohort were bicuspid aortic valve (BAV) patients. Around 80% of both NCC-parallel views and final views were in the right anterior oblique (RAO) and caudal (CAU) quadrant. There was less than 5° change required from the NCC-parallel view to the final implanted view in 79% of tricuspid aortic valve (TAV) patients but only in 27% (13/48) of type 0 BAV patients with coronary arteries originated from the different cusps. After excluding the above mentioned BAV patients, 62.3% (48/77) of BAV patients needed less than 5° change to achieve optimal projection and only in 8 patients, the angular change was larger than 10° in either left/right anterior oblique or cranial/caudal direction., Conclusions: The NCC-parallel technique provides reliable prediction for optimal projection in self-expanding TAVI in all TAV and most BAV patients, with a vast majority of views in the RAO and CAU quadrant., (© 2021. The Author(s).)

Background: The past decade has witnessed an ever-increasing momentum of transcatheter aortic valve replacement (TAVR) and a subsequent paradigm shift in the contemporary management of severe aortic stenosis (AS). We conducted a multi-centric TAVR registry based on Chinese patients (the China Aortic valve tRanscatheter Replacement registrY [CARRY]) to delineate the clinical characteristics and outcomes of Chinese patients who underwent TAVR and compare the results between different valve types in different Chinese regions., Methods: CARRY is an all-comer registry of aortic valve disease patients undergoing TAVR across China and was designed as an observational study that retrospectively included all TAVR patients at each participating site. Seven hospitals in China participated in the CARRY, and 1204 patients from April 2012 to November 2020 were included. Categorical variables were compared using the chi-squared test, and continuous variables were analyzed using a t test or analysis of variance (ANOVA) test. The Kaplan-Meier curve was used to estimate the risk of adverse events during follow-up., Results: The mean age of the patients was 73.8 ± 6.5 years and 57.2% were male. The median Society of Thoracic Surgeon-Predicted Risk of Mortality score was 6.0 (3.7-8.9). Regarding the aortic valve, the proportion of bicuspid aortic valve (BAV) was 48.5%. During the hospital stay, the stroke rate was 0.7%, and the incidence of high-degree atrioventricular block indicating permanent pacemaker implantation was 11.0%. The in-hospital all-cause mortality rate was 2.2%. After 1 year, the overall mortality rate was 4.5%. Compared to patients with tricuspid aortic valve (TAV), those with BAV had similar in-hospital complication rates, but a lower incidence of in-hospital mortality (1.4% vs. 3.3%) and 1 year mortality (2.3% vs. 5.8%)., Conclusions: TAVR candidates in China were younger, higher proportion of BAV, and had lower rates of post-procedural complications and mortality than other international all-comer registries. Given the use of early generation valves in the majority of the population, patients with BAV had similar rates of complications, but lower mortality than those with TAV. These findings further propel the extension of TAVR in low-risk patients., Trial Registration: https://www.chictr.org.cn/ (No. ChiCTR2000038526)., (Copyright © 2021 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license.)

We sought to assess the amount and distribution of force on the valve frame after transcatheter aortic valve replacement (TAVR) via patient-specific computer simulation. Patients successfully treated with the self-expanding Venus A-Valve and multislice computed tomography (MSCT) pre- and post-TAVR were retrospectively included. Patient-specific finite element models of the aortic root and prosthesis were constructed. The force (in Newton) on the valve frame was derived at every 3 mm from the inflow and at every 22.5° on each level. Twenty patients of whom 10 had bicuspid aortic valve (BAV) were analyzed. The total force on the frame was 74.9 N in median (interquartile range 24.0). The maximal force was observed at level 5 that corresponds with the nadir of the bioprosthetic leaflets and was 9.9 (7.1) N in all patients, 10.3 (6.6) N in BAV and 9.7 (9.2) N for patients with tricuspid aortic valve (TAV). The level of maximal force located higher from the native annulus in BAV and TAV patients (8.8 [4.8] vs. 1.8 [7.4] mm). The area of the valve frame at the level of maximal force decreased from 437.4 (239.7) mm 2 at the annulus to 377.6 (114.3) mm 2 in BAV, but increased from 397.5 (114.3) mm 2 at the annulus to 406.7 (108.9) mm 2 in TAV. The maximum force on the bioprosthetic valve frame is located at the plane of the nadir of the bioprosthetic leaflets. It remains to be elucidated whether this may be associated with bioprosthetic frame and leaflet integrity and/or function., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Some patients referred for transcatheter aortic valve replacement (TAVR) have excessively large annuli (ELA) without device options according to current sizing charts. This retrospective study aims to summarize the presentation and outcomes of ELA patients receiving first-generation self-expanding valves., Methods: The TAVR database was reviewed in search for cases of self-expanding valves. Patients who had annuli exceeding the perimeter limit on the device sizing chart were referred to as the ELA group. Patients who had annuli within the range covered by the two largest sizes and received the corresponding valve size served as the control group (CG). Baseline, procedures, outcomes, and imaging characteristics on multislice computed tomography (MSCT), such as native anatomy and postimplant stent geometry, were compared., Results: A total of 28 patients were included in the ELA group and 82 in the CG. The patients in the ELA group were younger than those in the CG (72.5 ± 6.2 vs. 75.4 ± 5.8 years, P = 0.03). The median intended perimeter oversizing in relation to the annulus in the ELA group was much smaller than in the CG (-0.4 [-4.6, 4.1] % vs. 16.1 [11.7, 20.8] %, P < 0.01). The calcium burden in the aortic root was around 1.3-fold greater in the ELA group than the CG (756.0 [534.5, 1670.9] vs. 582.1 [310.3, 870.9] mm 3 , P = 0.01). The need for second valve implantation was higher in ELA (21.4% vs. 12.2%, P = 0.23) but no valve embolization was encountered. The 1‑year follow-up was comparable, including >mild paravalvular leak., Conclusion: Under cautious patient selection using MSCT, TAVR with self-expanding valves in patients with ELA appears feasible. Supra-annular structures likely provide the extra anchoring., (© 2020. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Objectives: We sought to identify the impact of transcatheter aortic valve implantation (TAVI) on changes of fractional flow reserve computed tomography (FFR CT ) values and the associated clinical impact., Methods: A retrospective analysis was done with CT obtained pre-TAVI, prior to hospital discharge and at 1-year follow-up, which provided imaging sources for the calculation of FFR CT values based on an online platform., Results: A total of 190 patients were enrolled. Patients with pre-procedural FFR CT value > 0.80 (i.e., negative) and ≤ 0.80 (i.e., positive) demonstrated a significantly opposite change in the value after TAVI (0.8798 vs. 0.8718, p < 0.001 and 0.7634 vs. 0.8222, p < 0.001, respectively). The history of coronary artery disease (CAD) was identified as an independent predictor for FFR CT changing from negative to positive after TAVI (odds ratio [OR] 2.927, 95% confidence interval [CI] 1.130-7.587, p = 0.027), with lesions more severely stenosed (OR 1.039, 95% CI 1.003-1.076, p = 0.034) and in left anterior descending coronary artery (LAD) (OR 3.939, 95% CI 1.060-14.637, p = 0.041) being prone to change., Conclusions: TAVI directly brings improvement in FFR CT values in patients with compromised coronary flow. Patients with a history of CAD, especially with lesions more severely stenosed and in LAD, were under risk of FFR CT changing from negative to positive after TAVI., Key Points: •The effect of TAVI on coronary hemodynamics might be influenced by different ischemic severity and coronary territories reflected by FFR CT values. •As different FFR CT variations did not impact outcomes of TAVI patients, AS, but not coronary issues, may be the primary problem to affect, which needs further validation., (© 2021. European Society of Radiology.)

Objective: We hypothesize that different degree of pre-existing aortic regurgitation (AR) may affect the presence of hypo-attenuated leaflet thickening (HALT) after transcatheter aortic valve replacement (TAVR)., Background: The mechanism of the presence of HALT post-TAVR is not fully understood., Methods: We retrospectively evaluated the post-procedural multi-slice computed tomography (MSCT) before discharge for evidence of HALT. Patients were grouped according to the degree of pre-existing AR. Baseline, native anatomy and procedure details were compared, then multivariate regression was performed., Results: MSCT analyzed was performed at a median of 6 days post-TAVR in 179 patients. HALT was detected in 10.6% of patients. After adjusting for variables that were significantly different between groups, pre-existing ≥ moderate AR was protective to the risk of HALT (OR 0.15, 95% CI 0.03-0.84, p = .03). Stratifying for factors that might explain the impact of pre-existing AR on HALT, patients with a small Sinus of Valsalva, non-eccentric remodeling and receiving a large bioprosthesis experienced a sevenfold higher risk for HALT (OR 7.16, 95% CI 2.05-25.08, p = .002)., Conclusions: Patients underwent TAVR with pre-existing ≥ moderate AR appeared to experience a lower incidence of early HALT compared to those patients with less than moderate AR, which may be explained by a larger Sinus of Valsalva and a higher proportion of LV eccentric remodeling., (© 2020 Wiley Periodicals, Inc.)

Background: To explore why bicuspid aortic stenosis has certain clinical differences from the tricuspid morphology, we evaluated the metabolomics profile involved in bicuspid aortic valve (BAV) aortic stenosis prior to and after transcatheter aortic valve replacement (TAVR) in comparison with tricuspid aortic valve (TAV)., Methods: In this TAVR cohort with prospectively collected data, blood samples were obtained before TAVR valve deployment and at the 7th day after TAVR, which were then sent for liquid and gas chromatography-mass spectrometry detection. Besides comparisons between BAV and TAV, BAV patients were also divided in subgroups according to baseline hemodynamics (i.e. maximal transaortic velocity, V max ) and post-procedural reverse left ventricular (LV) remodeling (i.e. the change in LV mass index from baseline, ∆LVMI) for further analysis. Metabolic differences between groups were identified by integrating univariate test, multivariate analysis and weighted correlation network analysis algorithm., Results: A total of 57 patients were enrolled including 33 BAV patients. The BAV group showed lower arginine and proline metabolism both before and post TAVR than TAV represented by decreased expression of L-Glutamine. In BAV subgroup analysis, patients with baseline V max  > 5 m/s (n = 11) or the 4 th quartile of change in ∆LVMI at one-year follow-up (i.e. poorly-recovered LV, n = 8) showed elevated arachidonic acid metabolism compared with V max  < 4.5 m/s (n = 12) or the 1 st quartile of ∆LVMI (i.e. well-recovered LV, n = 8) respectively., Conclusions: Difference in arginine and proline metabolism was identified between BAV and TAV in TAVR recipients. Elevated arachidonic acid metabolism may reflect more severe baseline hemodynamics and worse LV reserve remodeling after TAVR in BAV.

Objectives: We evaluated the safety and usefulness of preparatory anatomical reshaping with a geometric hourglass-shaped balloon to optimize transcatheter aortic valve replacement (TAVR) outcomes in bicuspid aortic valve (BAV) stenosis., Background: TAVR has been increasingly performed for BAV stenosis; however, technical challenges remain. Procedural results are suboptimal given unfavorable valvular anatomies., Methods: Eligible patients with BAV stenosis were enrolled to undergo aortic valve predilatation with the hourglass-shaped TAV8 balloon before TAVR using the self-expandable Venus A-Valve. Procedural details and outcomes were compared to a sequential group of patients with BAV who underwent TAVR with the same device following preparatory dilatation using a cylindrical balloon., Results: A total of 22 patients were enrolled in the TAV8 group and 53 were included in the control group. Valve downsizing was less common in the TAV8 group (36.4 vs. 67.9%; p = .012). Stable valve release and optimal implant depth were consistently achieved in the TAV8 group with no requirement for a second valve (0 vs. 17.0%; p = .039) and with higher device success rates (100.0 vs 77.4%; p = .014). Residual aortic regurgitation graded as ≥mild was less common in the TAV8 group (13.6 vs 45.3%; p = .009). Mortality was similar (0 vs. 3.8%; p = 1); no major/disabling stroke or conversion to open-heart surgery was seen in either group within 30 days., Conclusions: Compared with standard cylindrical balloon valvuloplasty, preparatory reshaping with the hourglass-shaped balloon before self-expandable TAVR in BAV was associated with significantly better procedural results and may encourage more promising outcomes., (© 2020 Wiley Periodicals, Inc.)

Objectives: We aimed to assess the procedural and clinical results of transcatheter aortic valve replacement (TAVR) for nonraphe bicuspid aortic stenosis (AS) with coronary vs mixed cusp fusion., Background: It remains unclear whether cusp fusion morphology affects TAVR outcomes in patients with nonraphe bicuspid AS., Methods: This retrospective study enrolled consecutive patients with severe symptomatic AS and type-0 bicuspid aortic valve, who underwent TAVR at our institution between 2012 and 2017. TAVR outcomes were defined based on the Valve Academic Research Consortium-2 recommendations., Results: Compared to patients with mixed cusp fusion (44/71), those with coronary cusp fusion (27/71) had a larger ellipticity index for the aortic annulus (21.9% ± 9.0% vs 15.6% ± 9.3%, p =0.007) and increased left ventricular outflow tract obstruction (31.1% ± 9.4% vs 26.9% ± 7.5%, p =0.04) but comparable rates of second valve implantation (15.9% vs 14.8%), mild paravalvular leakage (PVL, 38.5% vs 30.2%), permanent pacemaker implantation (PPM, 25.9% vs 15.9%), and 30-day mortality (7.4% vs 6.8%). Use of a first-generation transcatheter heart valve was associated with higher risk for mild PVL (odds ratio (OR) = 4.37; 95% confidence interval (95% CI) = 1.14-16.75; p =0.03) but not PPM (OR = 0.77; 95% CI = 0.22-2.62; p =0.67), whereas a larger oversizing ratio tended to be associated with a higher PPM rate (OR = 1.49; 95% CI = 0.46-4.86; p =0.51) but lower incidence of mild PVL (OR = 0.51; 95% CI = 0.19-1.35; p =0.17)., Conclusions: In AS patients with type-0 bicuspid valves, cusp fusion morphology does not affect the procedural or clinical results of TAVR. Use of second-generation transcatheter heart valves may provide more favorable results in such patients. This trial is registered with NCT01683474., Competing Interests: Yuan Feng and Mao Chen are consultants/proctors of Venus MedTech. Other authors declared no conflicts of interest., (Copyright © 2019 Wen-hua Lei et al.)

Background: Studies of permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) specifically for bicuspid aortic valve (BAV) patients are lacking. We aim to delineate possible aspects that might affect the incidence of PPI in a retrospective cohort of BAV patients treated with early-generation self-expanding devices., Methods: A total of 80 patients with bicuspid morphology who successfully underwent TAVR by self-expanding devices without prior PPI were included. Baseline clinical, echocardiographic, and angiographic characteristics, procedural and post-procedural details were collected., Results: The incidence of PPI after early-generation self-expanding valves in this BAV cohort was 26.3%. Baseline characteristics were comparable between patients requiring PPI post-TAVR or not. Perimeter oversizing greater than 20% significantly increased the risk of PPI compared with an oversizing of 10-20% (OR 5.08 [1.22, 21.07], P = 0.03). The proportion of patients with a depth of implantation greater than 6 mm was significantly higher in those who required PPI (82.4% vs 54.3%, P = 0.04). When testing the impact of depth of implantation >6 mm and oversizing in different morphologies, only in type 1 bicuspid patients and by oversizing>20% increased the risk of PPI (OR 12.00 [1.25, 115.36], P = 0.03) compared with an oversizing of 10-20%., Conclusions: Excessive perimeter oversizing in relation to aortic annulus and depth of implantation greater than 6 mm should be avoided to improve PPI post-TAVR for BAV patients receiving self-expanding devices, especially for type 1 BAV., (© 2018 Wiley Periodicals, Inc.)

To compare reverse left ventricular (LV) remodeling after transcatheter aortic valve replacement (TAVR) between patients with bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV). We retrospectively reviewed data of patients with at least two serial echocardiographic follow-ups (1, 3, 6 months and 1 year) post-TAVR. A total of 116 patients were identified. BAV morphology was documented in 67 patients. LV mass index (LVMi) at baseline was not significantly different between the TAV and BAV group (178.0 ± 6.9 vs. 166.3 ± 6.4 g/m 2 , P = 0.14). Reverse LV remodeling was observed in both BAV and TAV patients, but the reduction of LVMi from baseline was significantly more pronounced in TAV patients compared with BAV patients from 6 months post-TAVR (- 56.3 ± 8.1 vs. - 30.0 ± 4.7 g/m 2 , P < 0.01 at 6-month follow-up; - 60.6 ± 7.6 vs. - 37.9 ± 6.2 g/m 2 , P = 0.02 at 1-year follow-up). EDV value changes during follow-up were similar between patient with TAV and BAV. There were no significant differences in the proportions of patients with more than mild PVL or new permanent pacemaker between TAV and BAV morphology throughout the follow-up. Patients with bicuspid morphology might experience less pronounced reverse LV remodeling post-TAVR than patients with tricuspid morphology.

The imaging finding of hypo-attenuated leaflet thickening (HALT) on bioprosthesis after transcatheter aortic valve replacement (TAVR) has been reported. The underlying mechanism is not clear, but leaflet thrombosis is speculated to be the cause. Heterogeneous antiplatelet responses may play a role in the process. This is a prospective, single-center pilot study in patients who received successful TAVR from June 2012 to November 2016. HALT on post-procedural multi-detector computed tomography. We thoroughly genotyped 34 SNPs and 8 SNPs that have been reported for clopidogrel and aspirin resistance. A total of 148 patients were enrolled. There were 15 patients demonstrating signs of HALT. Patients with HALT had a higher rate of atrial fibrillation (AF) pre-TAVR (33.3 vs. 7.5%, P = 0.01). We found that rs4244285 G>A polymorphism of the CYP2C19 gene was associated with the risk of HALT in the overdominant model (OR 4.00 [1.15-13.97], P = 0.02 for GA vs. GG+AA) adjusted by sex and the presence of pre-TAVR AF. Antiplatelet drug resistance is a reasonable possibility involved in HALT. Potential directions were suggested in polymorphisms of the CYP2C19 gene.

Background: Limited date describing the procedural, clinical and valve performance results of transcatheter aortic valve replacement (TAVR) in patients with bicuspid versus tricuspid aortic stenosis (TAV)., Methods: Procedural and clinical results were defined and reported according to VARC-2 criteria., Results: Consecutive 87 patients with BAV and 70 patients with TAV were included. Compared to patients with TAV, patients with BAV had similar incidence of second valve implantation (14.9% vs 12.9%, p=0.708), more than mild paravalvular leakage (PVL, 40.2% vs 31.9%, p=0.288), permanent pacemaker implantation (PPM, 24.1% vs 28.6%, p=0.53). Furthermore, the procedural and clinical results of TAVR also did not differ between patients with type 0 and type 1 (second valve implantation: 18.4% vs 11.8%, p=0.71, PVL: 38.8% vs 41.2%, p=0.83, PPM: 18.4% vs 31.6%, p=0.16). The hemodynamic outcomes were similar in patients with BAV and TAV at 1-year (maximum velocity, 2.3 vs 2.2m/s, p=0.307) and 2-year (2.3 vs 2.1m/s, p=0.184) follow-up respectively. Adjusted binary logistic regression analysis found oversizing ratio at 14.45-20.57% is at lower risk for more than mild PVL (OR, 0.069, 95% CI, 0.011-0.428, p=0.004). Moreover, the Kaplan-Meier survival analysis revealed that TAVR in type 0 BAV, type 1 BAV and TAV have comparable risk for midterm mortality (Log rank, p=0.772)., Conclusion: TAVR in whatever type of BAV appeared to be safe and efficacy, and TAVR in BAV was associated with comparable bioprosthetic function during follow up compared to patients with TAV., (Copyright © 2017. Published by Elsevier B.V.)

Aims: Limited information exists describing the results of transcatheter aortic valve replacement (TAVR) in patients with symptomatic severe non-calcific aortic stenosis (AS). We aimed to compare procedural, echocardiographic, and clinical outcomes among patients with non-calcific AS with those of senile calcific AS undergoing TAVR., Methods and Results: We retrospectively identified patients with non-calcific AS who received TAVR with self-expanding transcatheter heart valves in our centre. Clinical and echocardiographic outcomes, and post-procedural multi-detector computed tomography (MDCT) measures were compared to those in patients undergoing TAVR for calcific AS. Among 136 patients, 21 patients (15.4%) with native leaflet thickening and minimal calcification were identified (non-calcific group). The patients were significantly younger in the non-calcific group (70.0 [64.0-75.5] vs. 75.0 [69.0-78.0] years) with comparable STS-PROM scores (6.7 [4.8-8.9] vs. 8.2 [4.8-10.9] %). Predilation was performed less frequently (42.9% vs. 93.9%) and post-dilation more often (71.4% vs. 42.6%) in the non-calcific group. Both 30-day and one-year mortality were similar between groups (0% vs. 7.8% and 0% vs. 17.6%). Rates of post-implantation paravalvular leak ≥mild at six months (17.6% vs. 25.7%) were comparable despite lower implantation depth among non-calcific AS patients (10.9±5.7 vs. 7.2±4.3 mm) on post-implantation MDCT., Conclusions: TAVR with self-expanding transcatheter heart valves appears to be safe and effective in patients with non-calcific AS.

Background: TAVR is a rapidly spreading treatment option for severe aortic valve stenosis. Significant coronary artery disease (CAD) is present in 40% to 75% of patients undergoing TAVR. However, when to treat the concomitant coronary artery lesions is controversial., Methods: This is a systematic review comparing concomitant PCI and TAVR versus staged PCI and TAVR. The OVID database was systematically searched for studies reporting PCI in patients undergoing TAVR. A random effects model was used to calculate the pooled odds ratio (OR) with 95% confidence intervals., Results: Four observational studies and a total of 209 patients were included in this analysis. Overall 30-day mortality was similar between concomitant PCI and TAVR versus staged PCI and TAVR [OR: 1.47 (0.47-4.62); P = .51], renal failure was not significantly different between both groups [OR: 3.22 (0.61-17.12); P = .17], periprocedural myocardial infarction was not different between the 2 groups [OR: 1.44 (0.12-16.94); P = .77], life-threatening bleeding did not differ between both groups [OR: 0.45 (0.11-1.87); P = .27], and major stroke also was not significantly different [OR: 3.41 (0.16-74.2); P = .44]., Conclusion: These data did not show a significant difference in short-term outcomes between concomitant PCI and TAVR versus staged PCI and TAVR.

The aim of this study was to investigate the incidence, predictors and outcome of prosthesis-patient mismatch (PPM) following transcatheter aortic valve replacement (TAVR). A total of 30 articles incorporating 4,691 patients were identified. The pooled incidences of overall, moderate and severe PPM following TAVR were 33.0%, 25.0% and 11.0% respectively. Medtronic CoreValve (MCV) had lower incidence of overall (32% vs: 40%, P < 0.0001) and moderate (23% vs 32%, P < 0.0001) than Edwards Sapien (ESV). PPM was associated with a younger age, smaller annulus diameter and lower left ventricular ejection fraction in comparison with those patients without PPM. Post-dilation (OR, 0.51, 95% CI, 0.38 to 0.68, p < 0.001) during TAVR would decrease the incidence of PPM. Although PPM was common after TAVR, no significant differences were observed both in short- and mid-term all-cause mortality (30 day: OR: 1.1, 95% CI, 0.70 to 1.73 and 2 year: OR: 1.01, 95% CI, 0.74 to 1.38) between patients with PPM and those without PPM. In conclusion, despite being common after TAVR, the incidence of PPM was lower than that of surgical aortic valve replacement (SAVR) and decreased with the experience accumulating, and PPM was not seen to impact on short- and mid-term survival, regardless of its magnitude.

Aims: The aim of this systematic review and meta-analysis was to investigate the predictors and outcome of acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI)., Methods and Results: There were 35 articles recruiting 13,256 patients included in our study. Hypertension (odds ratio [OR] 1.92, 95% CI: 1.44 to 2.56), diabetes mellitus (OR 1.33, 95% CI: 1.20 to 1.47), peripheral artery disease (OR 1.28, 95% CI: 1.14 to 1.45) and a left ventricular ejection fraction <40% (OR 1.50, 95% CI: 1.19 to 1.88) were identified as significant independent predictors of AKI. In addition to the aforementioned comorbidities, procedure-related/post-TAVI factors such as transapical access (OR 1.68, 95% CI: 1.44 to 1.97), major bleeding (OR 1.82, 95% CI: 1.37 to 2.40) and transfusion (OR 1.30, 95% CI: 1.12 to 1.51) were also associated with a higher risk of AKI. Importantly, the risk of short-term all-cause death increased progressively with the aggravating severity of AKI (OR, 30 days: stage 1: 3.41; stage 2: 4.0; stage 3: 11.02; one year: stage 1: 1.95; stage 2: 2.82; stage 3: 7.34), as determined by a univariate analysis. After eliminating confounders, AKI remained linked to a higher risk for both short-term (30 days: HR 2.12, 95% CI: 1.59 to 2.83) and long-term (≥3 years: HR 1.37, 95% CI: 1.27 to 1.48) all-cause mortality., Conclusions: The reason for the occurrence of AKI was multifactorial, including baseline characteristics, procedure-related and post-TAVI factors. It appeared that even stage 1 AKI exerted detrimental effects on survival within one year, and AKI was also independently linked to mortality beyond three years.

Background: To investigate the individual sequential hemodynamic changes after transcatheter aortic valve implantation (TAVI), especially for patients with bicuspid aortic valve (BAV), in comparison with tricuspid aortic valve (TAV)., Methods: The study population comprised 85 patients with severe aortic stenosis who underwent TAVI for BAV (n = 49) or TAV (n = 36) with at least two serial echocardiographic follow-ups. Doppler echocardiography was scheduled to be performed at discharge and 1, 3, 6 months and 1 year after the procedure. D peak transvalvular velocities and D mean transvalvular gradients were calculated as the difference at follow-up time points and discharge. Paravalvular leak (PVL) was assessed as another indicator for prosthesis performance., Results: Comparisons between patients with BAV and TAV revealed similar gradient performances (1.00 [-2.00, 2.00] vs. 1.00 [-0.25, 5.00] mm Hg, p = 0.57 at 1 month; -0.71 ± 7.52 vs. 1.55 ± 3.97 mm Hg, p = 0.21 at 3 months; 0.96 ± 7.81 vs. 1.53 ± 5.85 mm Hg, p = 0.79 at 6 months; 1.00 [-0.50, 2.25] vs. 3.00 [-0.50, 7.50] mm Hg, p = 0.07 at 1 year). Moreover, the incidence of ≥ mild PVL was not significantly different in patients with BAV and TAV during follow-up (34.88% vs. 19.35%, p = 0.14 at 1 month; 45.83% vs. 27.27%, p = 0.19 at 3 months; 30.00% vs. 23.53%, p = 0.89 at 6 months; 30.00% vs. 17.65%, p = 0.56 at 1 year)., Conclusions: TAVI is effective and applicable in BAV anatomy with sustained and acceptable mid- -term prosthesis hemodynamic performance. (Cardiol J 2017; 24, 4: 350-357).

Evidence regarding the safety and feasibility of transcatheter aortic valve implantation without balloon predilation (BP) is scarce. A literature search of PubMed, EMBASE, CENTRAL, and major conference proceedings was performed from January 2002 to July 2015. There were 18 studies incorporating 2,443 patients included in the present study. No differences were observed in the baseline characteristics between patients without BP (no-BP) and with BP. Compared with BP, no-BP had a shorter procedure time (no-BP vs BP, 124.2 vs 138.8 minutes, p = 0.008), used less-contrast medium (no-BP vs BP, 126.3 vs 156.3 ml, p = 0.0005) and had a higher success rate (odds ratio [OR] 2.24, 95% CI 1.40 to -3.58). In addition, no-BP was associated with lower incidences of permanent pacemaker implantation (OR 0.45, 95% CI 0.3 to 0.67), grade 2 or greater paravalvular leakage (OR 0.55, 95% CI 0.37 to 0.83), and stroke (OR 0.57, 95% CI 0.32 to 1.0). Furthermore, no-BP was associated with a 0.6-fold decreased risk for 30-day all-cause mortality (OR 0.60, 95% CI 0.39 to 0.92). However, the difference in the risk for permanent pacemaker implantation, grade 2, or higher aortic regurgitation, stroke was noted to be significant only in the subgroup of the CoreValve-dominating studies. In conclusion, no-BP before transcatheter aortic valve implantation was not only safe and feasible but was also associated with fewer complications and short-term mortality in selected patients especially using self-expandable valve., (Copyright © 2016 Elsevier Inc. All rights reserved.)