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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: 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.)

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.)

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.

Background: The 3rd generations of transcatheter heart valve system, including Edwards SAPIEN S3 (ES3) and Medtronic's Evolut R, has been developed to specifically improve the safety of transcatheter aortic valve implantation (TAVI). The aim of this work was to provide a summary effect estimate of the peri-procedural characteristics and clinical outcome of patients treated with ES3 versus the Evolut R., Methods: We conducted a literature search of PubMed, Ovid and EMBASE (2002 to 2018). Two authors extracted the data independently. The safety and feasibility of Sapien 3 and Evolut R were compared by odds ratios (ORs) with 95% confidence intervals (CIs) in inverse variance method., Results: After a multi-step assessment, a total 6 studies were finally included, yielding 1,664 patients, of which, 768 (46%) used ES3 and 896 (54%) used Evolut R. There was no statistical difference with device success rate (OR 1.15, 95% CI: 0.70-1.91, I2 =0%), 30-day mortality [OR: 0.72 (0.33-1.57), I2 =0%], pre-dilation rate, 30-day stroke, bleeding complication (BC) (major and life-threating), major vascular complication (VC), and paravalvular leakage between the two groups. However, the ES3 group was associated with a higher risk of acute kidney injury (AKI), higher mean aortic valve gradient and better mean left ventricular ejection fraction (LVEF) after TAVR procedure. Moreover, the Evolut R group had a higher rate of post-dilation and new permanent pacemaker implantation (PPMI)., Conclusions: Both devices had demonstrated excellent procedural success rate and short-term safety. At 30-day follow-up, both devices shared similar rates of mortality, BC, VC, stroke, and paravalvular leakage (PVL). However, the rate of AKI was higher in the ES3 group, and the rate of PPM was higher in the Evolut R group.

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.)

Objectives: The natural history of ascending aortic diameter after transcatheter aortic valve implantation (TAVI) has not been investigated. Our aim was to determine the progression of ascending aortic diameter in patients undergoing TAVI., Methods: We retrospectively included 134 patients undergoing TAVI for aortic stenosis at our institution from June 2012 to November 2016, including 79 patients with bicuspid aortic valve (BAV) and 55 patients with tricuspid aortic valve (TAV). Preoperative measurements of the ascending aorta were compared with aortic measurements at 1-year follow-up based on computed tomography images., Results: A very slight decrease in median aortic diameter was identified in overall patients: 4.07 cm (interquartile range [IQR], 3.76-4.54 cm) vs 4.06 cm (IQR, 3.74-4.51 cm); P=.04. Further subgroup analysis found that the decrease remained statistically significant in the subgroup of TAV and mild aortic dilation. In addition, no aortic events occurred during long-term follow-up (median, 27 months; IQR, 20-42 months)., Conclusions: TAVI could prevent a further progression of aortic diameter for both BAV or TAV patients by correcting hemodynamic derangements, especially for patients with TAV, mild aortic dilation, and small annulus angles. Aortic events appeared rarely during long-term follow-up after TAVI. However, our results need further confirmation with future investigations in a larger population with longer-term follow-up.

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.

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: Transcatheter aortic valve implantation (TAVI) has been demonstrated to be an effective alternative to surgical aortic valve replacement (SAVR) in patients with aortic stenosis who are deemed high risk or inoperable. Currently, TAVI procedures in China mostly make use of the domestic Venus A-Valve and the CoreValve; however, there is no data on their comparative performance., Methods: Consecutive patients undergoing TAVI with the aforementioned devices were included. The outcomes were reported according to the Valve Academic Research Consortium-2 (VARC) definitions., Results: A total of 54 TAVI procedures were performed, 27 with the CoreValve and the other 27 with the Venus A-Valve. An additional valve was required in 4 (14.8%) and 3 (11.1%) patients, and the VARC-2 device success rates were 81.5 and 85.2%, respectively. The incidences of common complications were similar, except for the significantly less frequent pacemaker insertion in the Venus A-Valve group (7.4 vs. 37.0%, P = 0.03). Within 30 days, 2 (3.7%) patients died, 1 in each group, and both had a bicuspid aortic valve (BAV). No other serious complications, such as annular rupture, coronary obstruction and aortic dissection, occurred in the 32 BAV patients treated with the Venus A-Valve (14) or the CoreValve (18). After 2-years of follow-up, there was no significant difference between CoreValve group and Venus-A group (11.1 vs. 7.4%, P = 0.64)., Conclusion: TAVI with the domestic Venus A-Valve is feasible, safe, and can produce favorable short-term outcomes comparable to those with the CoreValve in inoperable or high-risk patients with tricuspid and bicuspid aortic valve stenosis. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

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).

Objectives: This study sought to evaluate transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) aortic stenosis (AS), with a particular emphasis on TAVR-directed bicuspid aortic valve imaging (BAVi) of morphological classification., Background: TAVR has been used to treat BAV-AS but with heterogeneous outcomes and uncertainty regarding the relevance of morphology., Methods: In 14 centers in the United States, Canada, Europe, and Asia, 130 BAV-AS patients underwent TAVR. Baseline cardiac computed tomography (CT) was analyzed by a dedicated Corelab. Outcomes were assessed in line with Valve Academic Research Consortium criteria., Results: Bicommissural BAV (vs. tricommissural) accounted for 68.9% of those treated in North America, 88.9% in Europe, and 95.5% in Asia (p = 0.003). For bicommissural bicuspids, non-raphe type (vs. raphe type) BAV accounted for 11.9% of those treated in North America, 9.4% in Europe, and 61.9% in Asia (p < 0.001). Overall rates of 30-day mortality (3.8%) and cerebrovascular events (3.2%) were favorable and similar among anatomical subsets. The rate of new permanent pacemaker insertion was high (26.2%) and similar between balloon-expandable (BE) and self-expanding (SE) designs (BE: 25.5% vs. SE: 26.9%; p = 0.83); there was a trend to greater permanent pacemaker insertion in BE TAVR in the presence of coronary cusp fusion BAV morphology. Paravalvular aortic regurgitation (PAR) ≥ moderate was 18.1% overall but lower at 11.5% in those with pre-procedural CT. In the absence of pre-procedural CT, there was an excess of PAR in BE TAVR that was not the case in those with a pre-procedural CT; SE TAVR required more post-dilation. Predictors of PAR included intercommissural distance for bicommissural bicuspids (odd ratio [OR]: 1.37; 95% confidence interval [CI]: 1.02 to 1.84; p = 0.036) and lack of a baseline CT for annular measurement (OR: 3.03; 95% CI: 1.20 to 7.69; p = 0.018)., Conclusions: In this multicenter study, TAVR achieved favorable outcomes in patients with pre-procedural CT, with the exception of high permanent pacemaker rates for all devices and shapes., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.)

Objective: The present study was performed to investigate the relationship between chronic obstructive pulmonary disease (COPD) and transcatheter aortic valve implantation (TAVI)., Background: Controversies regarding the relationship between COPD and TAVI have intensified., Methods: A literature review of the PubMed online database was performed, and articles published between January 1, 2002 and March 20, 2015 were analyzed. Random-effect and fixed-effect models were used, depending on the between-study heterogeneity., Results: A total of 28 studies, involving 51,530 patients, were identified in our review. The burden of COPD ranged from 12.5% to 43.4%, and COPD negatively impacted both short-term and long-term all-cause survival (30 days: odds ratio [OR], 1.43, 95% CI, 1.14-1.79; >2 years: hazard ratio [HR], 1.34, 95% CI, 1.12-1.61). COPD was also associated with increased short-term and mid-term cardiac-cause mortality (30 days: OR, 1.29, 95% CI, 1.02-1.64; 1 year: HR: 1.09, 1.02-1.17). Moreover, COPD (OR, 1.97, 95% CI, 1.29-3.0) predicted post-TAVI acute kidney disease. Importantly, chronic kidney disease (CKD) (HR, 1.2, 95% CI, 1.1-1.32) and the distance of the 6 minute walk test (6MWT) (HR, 1.16, 1.06-1.27) predicted TAVI futility in patients with COPD., Conclusion: COPD is common among patients undergoing TAVI, and COPD impacts both short- and long-term survival. COPD patients, who had a lower BMI, shorter distance of 6MWT and CKD, were at higher risk for TAVI futility., (© 2016 Wiley Periodicals, Inc.)

Background: Transcatheter aortic valve replacement (TAVR) is an effective alternative to surgical aortic valve replacement in patients at high surgical risk. However, there is little published literature on the exact causes of death., Methods and Results: The PubMed database was systematically searched for studies reporting causes of death within and after 30 days following TAVR. Twenty-eight studies out of 3934 results retrieved were identified. In the overall analysis, 46.4% and 51.6% of deaths were related to noncardiovascular causes within and after the first 30 days, respectively. Within 30 days of TAVR, infection/sepsis (18.5%), heart failure (14.7%), and multiorgan failure (13.2%) were the top 3 causes of death. Beyond 30 days, infection/sepsis (14.3%), heart failure (14.1%), and sudden death (10.8%) were the most common causes. All possible subgroup analyses were made. No significant differences were seen for proportions of cardiovascular deaths except the comparison between moderate (mean STS score 4 to 8) and high (mean STS score >8) -risk patients after 30 days post-TAVR (56.0% versus 33.5%, P=0.005)., Conclusions: Cardiovascular and noncardiovascular causes of death are evenly balanced both in the perioperative period and at long-term follow-up after TAVR. Infection/sepsis and heart failure were the most frequent noncardiovascular and cardiovascular causes of death. This study highlights important areas of clinical focus that could further improve outcomes after TAVR., (© 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Background: There is conflicting evidence regarding the impact of preexisting renal dysfunction (RD) on mid-term outcomes after transcatheter aortic valve implantation (TAVI) in patients with symptomatic aortic stenosis (AS)., Methods and Results: Forty-seven articles representing 32,131 patients with AS undergoing a TAVI procedure were included in this systematic review and meta-analysis. Pooled analyses were performed with both univariate and multivariate models, using a fixed or random effects method when appropriate. Compared with patients with normal renal function, mid-term mortality was significantly higher in patients with preexisting RD, as defined by the author (univariate hazard ratio [HR]: 1.69; 95% confidence interval [CI]: 1.50-1.90; multivariate HR: 1.47; 95% CI: 1.17-1.84), baseline estimated glomerular filtration rate (eGFR) (univariate HR: 1.65; 95% CI: 1.47-1.86; multivariate HR: 1.46; 95% CI: 1.24-1.71), and serum creatinine (univariate HR: 1.69; 95% CI: 1.48-1.92; multivariate HR: 1.65; 95% CI: 1.36-1.99). Advanced stage of chronic kidney disease (CKD stage 3-5) was strongly related to bleeding (univariate HR in CKD stage 3: 1.30, 95% CI: 1.13-1.49; in CKD stage 4: 1.30, 95% CI: 1.04-1.62), acute kidney injure (AKI) (univariate HR in CKD stage 3: 1.28, 95% CI: 1.03-1.59; in CKD stage 4: 2.27, 95% CI: 1.74-2.96), stroke (univariate HR in CKD stage 4: 3.37, 95% CI: 1.52-7.46), and mid-term mortality (univariate HR in CKD stage 3: 1.57, 95% CI: 1.26-1.95; in CKD stage 4: 2.77, 95% CI: 2.06-3.72; in CKD stage 5: 2.64, 95% CI: 1.91-3.65) compared with CKD stage 1+2. Patients with CKD stage 4 had a higher incidence of AKI (univariate HR: 1.70, 95% CI: 1.34-2.16) and all-cause death (univariate HR: 1.60, 95% CI: 1.28-1.99) compared with those with CKD stage 3. A per unit decrease in serum creatinine was also associated with a higher mortality at mid-term follow-up (univariate HR: 1.24, 95% CI: 1.18-1.30; multivariate HR: 1.19, 95% CI: 1.08-1.30)., Conclusions: Preexisting RD was associated with increased mid-term mortality after TAVI. Patients with CKD stage 4 had significantly higher incidences of peri-procedural complications and a poorer prognosis, a finding that should be factored into the clinical decision-making process regarding these patients.

Transcatheter aortic valve implantation (TAVI) is an established therapeutic option for high-risk patients with tricuspid aortic valve stenosis. Historically, the presence of a bicuspid aortic valve (BAV) has been regarded as a contraindication to TAVI, on the basis of putative concerns about the associated risks of elliptical deployment, accelerated leaflet degeneration, periprosthetic leaks, and aortic complications. Fortunately, with technological refinements and mounting experience, reasonable success has been achieved with TAVI in selected patients with a BAV. The rate of procedural success is high, and survival is similar to that in patients with a tricuspid aortic valve who undergo TAVI. Nevertheless, moderate or severe aortic regurgitation and aortic dissection seem to occur more frequently in patients with a BAV rather than a tricuspid aortic valve. Specifically-designed prospective studies should address these concerns and help to define anatomical selection criteria before TAVI can be recommended for patients with a BAV.

There were considerable discrepancies with regard to sex-related differences in complications and prognosis after transcatheter aortic valve implantation.The Cochrane library and PubMed online databases were searched. Articles reporting sex-specific post-transcatheter aortic valve implantation complications and mortality were identified. Two authors selected studies and extracted data independently. Random- and fixed-effects models were used depending on between-study heterogeneity. There were 27 articles, a total of 9118 patients, enrolled in our systematic review and meta-analysis, including 4176 men and 4942 women. Pooled analyses suggested considerable sex-related differences in complications and early as well as midterm outcomes after transcatheter aortic valve implantation. The difference in the risk for heart block requiring permanent pacemaker implantation was noted to be significant only in the subgroup of the CoreValve-dominating studies (pooled risk ratio [RR, men versus women], 1.29; 95% confidence interval [CI], 1.13-1.47). Although men had significantly lower risks for major/life-threatening bleeding (pooled RR, 0.81; 95% CI, 0.68-0.96) and major vascular complications (pooled RR, 0.49; 95% CI, 0.37-0.66), they had poorer prognosis. In fact, male sex was associated with significantly higher risks for deaths at both 30 days (RR, 1.37; 95% CI, 1.07-1.76) and 1 year (RR, 1.30; 95% CI, 1.14-1.49).Although men had lower risks for major/life-threatening bleeding and major vascular complications after transcatheter aortic valve implantation, they had less favorable short-term and midterm survival. [ABSTRACT FROM AUTHOR]

Introduction: Little has been reported on dietary choices and obesity in patients with valvular heart disease. Hypothesis: We hypothesized that obesity is prevalent in patients with aortic stenosis and that significant differences in heart-healthy dietary choices may be observed between obese and non-obese patients. Methods: Consecutive patients with severe or critical aortic stenosis (AS) were evaluated in a busy Heart Valve Clinic for consideration of surgical or transcatheter valve replacement. All patients underwent a detailed dietary evaluation with a rate your plate (RYP) questionnaire. Obesity was defined as body mass index (BMI) ≥ 30 kg/m2. Dietary data was stratified according to presence of obesity. Data was analyzed by student's t-test for continuous data and chi-squared analysis for categorical data. Results: A total of 138 patients were evaluated; of these, 41 (29.7%) were obese. Overall there was no difference in the RYP score for obese and non-obese patients. However, obese patients scored significantly worse on RYP heart-healthy (HH) choices for fried foods and grains (table) with no significant differences in other categories. Conclusions: Obesity is common in patients with severe aortic stenosis. Self-reported heart-healthy choices differ only in categories of fried foods and grains (figure) which may be a good initial focus for nutritional intervention in this population. [ABSTRACT FROM AUTHOR]

Introduction: Diet and hyperlipidemia are correlated to coronary atherosclerosis, whose progression may be modulated by statin therapy. Aortic stenosis and calcification are atherosclerotic processes but they are not influenced by statin therapy. Limited data is available on the influence or correlates of diet on aortic valve calcification. Hypothesis: We hypothesized that diet may be related to aortic valve calcification (AVC) on computed tomography (CT). Methods: Consecutive patients with severe or critical aortic stenosis (AS) were evaluated in a busy Heart Valve Clinic and underwent both detailed dietary evaluation with a rate your plate (RYP) questionnaire and a high resolution CT as part of their work-up for valvular intervention (medical therapy, surgical or transcatheter aortic valve replacement). AVC volume was quantified using a validated method based on a higher threshold of detection from the contrast CT (850 Hounsfield Units, HU-850). Dietary data was separated according to patients in the highest tertile of AVC. Results: A total of 117 patients were evaluated. The upper tertile threshold of AVC was identified as 284.5 mm3 (figure: examples above and below this threshold are shown). Higher scores on RYP identify heart-healthy choices. There were no differences in the overall total RYP score or percentages of specific heart-healthy dietary choices according to AVC severity (table). Conclusions: AVC severity is unrelated to heart-healthy dietary choices in patients with aortic stenosis. [ABSTRACT FROM AUTHOR]