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Background: There has not been a consensus on the prothesis sizing strategy in type 0 bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR). Modifications to standard annular sizing strategies might be required due to the distinct anatomical characteristics. We have devised a downsizing strategy for TAVR using a self-expanding valve specifically for patients with type 0 bicuspid AS. The primary aim of this study is to compare the safety and efficacy of downsizing strategy with the Standard Annulus Sizing Strategy in TAVR for patients with type 0 bicuspid AS., Trial Design: It is a prospective, multi-center, superiority, single-blinded, randomized controlled trial comparing the Down Sizing and Standard Annulus Sizing Strategy in patients with type 0 bicuspid aortic stenosis undergoing transcatheter aortic valve replacement. Eligible participants will include patients with severe type 0 bicuspid AS, as defined by criteria such as mean gradient across aortic valve ≥40 mmHg, peak aortic jet velocity ≥4.0 m/s, aortic valve area (AVA) ≤1.0 cm², or AVA index ≤0.6 cm 2 /m 2 . These patients will be randomly assigned, in a 1:1 ratio, to either the Down Sizing Strategy group or the Standard Sizing Strategy group. In the Down Sizing Strategy group, a valve one size smaller will be implanted if the "waist sign" manifests along with less than mild regurgitation during balloon pre-dilatation. The primary end point of the study is a composite of VARC-3 defined device success, absence of both permanent pacemaker implantation due to high-degree atrioventricular block and new-onset complete left bundle branch block., Conclusion: This study will compare the safety and efficacy of Down Sizing Strategy with the Standard Annulus Sizing Strategy and provide valuable insights into the optimal approach for sizing in TAVR patients with type 0 bicuspid AS. We hypothesize that the Down Sizing Strategy will demonstrate superiority when compared to the Standard Annulus Sizing Strategy. (Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0) (TAILOR-TAVR), NCT05511792)., Competing Interests: Disclosure The authors declare that they have no competing interests., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Introduction: The membranous septum (MS) length measured by cardiac computed tomography (CT) is useful for the prediction of permanent pacemaker implantation (PPMI) and new left bundle branch block (LBBB) after transcatheter aortic valve replacement. However, its predictive value for patients undergoing surgical aortic valve replacement (SAVR) is unknown., Methods: A total of 2531 consecutive patients were registered in the institutional Society of Thoracic Surgeons database between July 2017 and June 2020. Patients who underwent non-SAVR procedures, had prior pacemaker/implantable cardioverter defibrillator, prior SAVR, no preprocedural CT assessment, or suboptimal CT imaging were excluded., Results: A total of 126 SAVR with preprocedural CT assessment were analyzed. Bicuspid aortic valve morphology was confirmed on CT in 59.5% of patients. There were three new PPMIs and five new LBBBs observed after SAVR at the time of discharge. In-hospital mortality was 0.8%. Low left ventricular (LV) ejection fraction (<50%), LV mass index >120 g/m 2 , large right coronary artery height, and MS length <1.5 mm predicted new PPMI/LBBB. Multivariate analysis showed LV mass index >120 g/m 2 (odds ratio: 9.165; 95% confidence interval: 1.644-51.080; P = 0.011) and MS length <1.5 mm (odds ratio: 14.449; 95% confidence interval: 1.632-127.954; P = 0.016) were independent predictors for new PPMI/LBBB., Conclusions: Short MS length on preoperative cardiac CT is a powerful and novel predictor for the risk of new PPMI/LBBB after SAVR. Special care should be taken in patients with short MS length to avoid suture-mediated trauma., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) might be a feasible treatment option for more patients with bicuspid aortic valve (BAV) stenosis. However, long-term follow-up data in this population are scarce., Aims: The aim of this study was to evaluate three-year outcomes after TAVI in patients with BAV., Methods: A total of 246 consecutive patients who underwent TAVI at a single centre in China between March 2013 and February 2018 were enrolled in this study. Clinical outcomes, health status and echocardiography were followed and recorded for three years., Results: Among 109 (44.3%) BAV patients, 61.5% were Type 0 and 36.7% were Type 1 BAV patients. BAV patients were younger (75 vs 77 years, p=0.041) and had a lower Society of Thoracic Surgeons (STS) score (5.09 vs 6.00, p=0.026) compared to tricuspid aortic valve (TAV) patients. There were no differences in three-year survival rates between bicuspid and tricuspid patients (87.1% vs 79.5%, log-rank p=0.126). Multivariate Cox regression analysis adjusting for confounding factors revealed a similar risk of all-cause mortality in the BAV population (hazard ratio [HR] 0.86, 95% confidence interval [CI]: 0.44-1.70, p=0.666). Except for the rate of permanent pacemaker implantation that was lower in BAV patients (11.9% vs 21.9%, p=0.041), the incidence of other clinical adverse events was comparable between the two groups. Both BAV and TAV patients showed an obvious improvement in valve haemodynamics, which was sustained for three years. In addition, similar left ventricular reverse remodelling was found during follow-up., Conclusions: BAV patients showed similar satisfactory three-year clinical outcomes, persistent valve haemodynamics improvement, and obvious cardiac reverse remodelling after TAVI compared to TAV patients.

Objectives: We aimed to validate a novel staging system for aortic stenosis (AS) in a Chinese patient cohort undergoing transcatheter aortic valve replacement (TAVR), and to compare this classification system to the traditional Society of Thoracic Surgeons (STS) score for TAVR risk stratification., Background: A novel staging system for AS based on the extent of cardiac damage upon echocardiography was recently proposed., Methods: Patients were prospectively enrolled into the Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population and analyzed retrospectively following additional exclusion criteria. On the basis of echocardiographic findings of cardiac damage, patients were classified into five stages (0-4)., Results: A total of 427 patients were included in the current analysis. Forty-eight deaths occurred during a median follow-up of 730 days following TAVR. The staging system showed a statistically significant association between cardiac damage and all-cause mortality; advanced stages were associated with higher mortality. In a multivariate-adjusted Cox proportional hazards regression model, stage and STS scores served as risk factors for 2-year mortality. Each increment in the staging class was associated with an increased risk of mortality (hazard ratio, 1.275; 95% confidence interval [CI], 1.052-1.545). Receiver operating characteristic (ROC) curves were plotted for stage (area under the curve, 0.644; 95% CI, 0.562-0.725) and STS score (0.661; 0.573-0.749), and with no statistically significant differences between ROC curves (p = 0.920)., Conclusions: We validated a novel staging system as a key risk factor for 2-year mortality in a Chinese TAVR patient cohort. Efficacy for risk stratification was comparable to the STS score., (© 2022 Wiley Periodicals LLC.)

Background: Patients with renal insufficiency have poor short-term outcomes after transcatheter aortic valve replacement (TAVR)., Methods: Retrospective chart review identified 575 consecutive patients not on hemodialysis who underwent TAVR between September 2014 and January 2017. Outcomes were defined by VARC-2 criteria. Primary outcome of all-cause mortality was evaluated at a median follow-up of 811 days (interquartile range 125-1,151)., Results: Preprocedural glomerular filtration rate (GFR) was ≥60 ml/min in 51.7%, 30-60 ml/min in 42.1%, and < 30 ml/min in 6.3%. Use of transfemoral access (98.8%) and achieved device success (91.0%) did not differ among groups, but less contrast was used with lower GFR (23 ml [15-33], 24 ml [14-33], 13 ml [8-20]; p < .001). Peri-procedural stroke (0.7%, 2.1%, 11.1%; p < .001) was higher with lower GFR. Core lab analysis of preprocedural computed tomography scans of patients who developed a peri-procedural stroke identified potential anatomic substrate for stroke in three out of four patients with GFR 30-60 ml/min and all three with GFR <30 ml/min (severe atheroma was the most common subtype of anatomical substrate present). Compared to GFR ≥60 ml/min, all-cause mortality was higher with GFR 30-60 ml/min (HR 1.61 [1.00-2.59]; aHR 1.61 [0.91-2.83]) and GFR <30 ml/min (HR 2.41 [1.06-5.48]; aHR 2.34 [0.90-6.09]) but not significant after multivariable adjustment. Follow-up echocardiographic data, available in 63%, demonstrated no difference in structural heart valve deterioration over time among groups., Conclusions: Patients with baseline renal insufficiency remain a challenging population with poor long-term outcomes despite procedural optimization with a transfemoral-first and an extremely low-contrast approach., (© 2020 Wiley Periodicals LLC.)

Background: Surgical aortic valve replacement (SAVR) has long been the standard treatment for patients with severe aortic stenosis in China, but the costs of SAVR from a hospital perspective in China have not been thoroughly researched. Currently, diagnosis-related groups in China are based on historical expenses that are closely related to the unit charges set by the official pricing department and are frequently inaccurate compared with actual resource consumption. Materials & methods: Through a retrospective empirical study on the costs and charges of SAVR cases in a tertiary hospital, this study aimed to compare the costs and charges of service items. We collected clinical information from patients undergoing SAVR (isolated or concomitant procedures) and financial information from the hospital in 2015 and 2016. Top-down full cost accounting and step-allocation were the main methods used in this study. Result: This research selected 203 SAVR cases in 2015 and 214 cases in 2016. The median length of hospital stay was 15.92 days (6.07 days pre surgery and 9.57 days post surgery). The average human resource cost of care per day per bed in the cardiovascular surgery department, including doctors and nurses, was US $62.22 in 2015 and $66.17 in 2016, but the corresponding charge was no more than $24. For operation, the cost of isolated SAVR was $665 in 2015 and $1015 in 2016, while the charge was $820. For anesthesiology, the cost of isolated SAVR was $400 in 2015 and $526 in 2016, while the average charge was $192. For examination service items, some costs did not exceed charges. The average total cost of a case was $19,299 ± 8954, while the average total charge was $18,923 ± 9194. Conclusion: SAVR is associated with significant resource utilization and hospital stay duration. The fees for human resources and services associated with SAVR do not reflect the true costs of SAVR in a Chinese hospital setting. This study may assist in future budget planning and price setting for policy makers in China.

Far less attention has been paid to the prognostic effect of right-side heart disease on outcomes after transcatheter aortic valve replacement (TAVR) when compared with the left side. Therefore, we performed a systematic review and meta-analysis on the impact of tricuspid regurgitation (TR) and right ventricular (RV) dysfunction on outcomes after TAVR. We hypothesized that TR and RV dysfunction may have a deleterious effect on outcomes after TAVR. Article revealing the prognostic effect of TR and RV dysfunction on outcomes after TAVR were being integrated. Random or fixed effect model was adopted in accordance with the heterogeneity. There were nine studies with a total of 6466 patients enrolled after a comprehensive literature search of the MEDLINE/PubMed, EMBASE, ISI Web of Science, and Cochrane databases. The overall analysis revealed that moderate or severe TR at baseline increased all-cause mortality after TAVR (HR = 1.79, CI 95% 1.52-2.11, P < 0.001). Both baseline RV dysfunction (HR = 1.53, CI 95% 1.27-1.83, P < 0.001) and presence of RV dilation (HR = 1.83, CI 95% 1.47-2.27, P < 0.001) were associated with all-cause mortality. Both baseline moderate or severe TR and RV dysfunction worsen prognosis after TAVR and careful assessment of right heart function should be done for clinical decision by the heart team before the TAVR procedure., (© 2018 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.)

Objectives: To explore assessment of supra-annular structure for self-expanding transcatheter heart valve (THV) size selection in patients with bicuspid aortic stenosis (AS)., Background: Annulus-based device selection from CT measurement is the standard sizing strategy for tricuspid aortic valve before transcatheter aortic valve replacement (TAVR). Because of supra-annular deformity, device selection for bicuspid AS has not been systemically studied., Methods: Twelve patients with bicuspid AS who underwent TAVR with self-expanding THVs were included in this study. To assess supra-annular structure, sequential balloon aortic valvuloplasty was performed in every 2 mm increments until waist sign occurred with less than mild regurgitation. Procedural results and 30 day follow-up outcomes were analyzed., Results: Seven patients (58.3%) with 18 mm; three patients (25%) with sequential 18 mm, 20 mm; and only two patients (16.7%) with sequential 18 mm, 20 mm, and 22 mm balloon sizing were performed, respectively. According to the results of supra-annular assessment, a smaller device size (91.7%) was selected in all but one patient compared with annulus based sizing strategy, and the outcomes were satisfactory with 100% procedural success. No mortality and 1 minor stroke were observed at 30 d follow-up. The percentage of NYHA III/IV decreased from 83.3% (9/12) to 16.7% (2/12). No new permanent pacemaker implantation and no moderate or severe paravalvular leakage were found., Conclusions: A supra-annular structure based sizing strategy is feasible for TAVR in patients with bicuspid AS., (© 2018 The Authors Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.)

Objectives: The importance of thrombocytopenia (TP) has been discussed previously. However, data are still limited, especially on predictors of TP. We sought to investigate predictors of TP after transcatheter aortic valve replacement (TAVR), in particular, clinically significant TP., Methods: We reviewed a total of 123 consecutive patients undergoing TAVR in our medical center. They were stratified into 3 groups according to the nadir platelet count post-TAVR: no/mild TP, moderate TP, and severe TP. Clinically significant TP, also known as major TP, was defined as moderate-to-severe TP (a nadir platelet count <100 × 109/L and a >50% decrease in platelet count)., Results: Baseline platelet, baseline hemoglobin, general anesthesia (GA), valve malpositioning and post-TAVR left ventricular ejection fraction were found to be predictors of post-TAVR nadir platelet count. Major TP was associated with a higher risk of major bleeding (OR 3.524, 95% CI 1.546-8.031) and 1-month mortality (OR 11.226, 95% CI 1.208-104.328). Age (OR 1.110, 95% CI 1.014-1.215) and GA (OR 6.494, 95% CI 2.058-20.408) were predictors of major TP., Conclusion: Post-TAVR nadir platelet count can be predicted based on baseline and procedural data. Old age and GA contribute to clinically significant TP., (© 2018 S. Karger AG, Basel.)

Severe bleeding (SB) in patients who underwent transcatheter aortic valve implantation (TAVI) could be fatal. Although multiple independent predictors of bleeding post-TAVI have been identified, the definitions of bleeding and predictors vary across studies. This study aimed to provide summary effect estimates for predictors of SB within 30 days post-TAVI. A systematic review of studies that reported the incidence of bleeding post-TAVI with raw data for predictors of interest was performed. Data on characteristics of study, patient, and procedure were extracted. Crude risk ratios (RRs) and 95% confidence intervals were calculated using random-effect model. Fifteen predictors on 65,209 patients from 47 studies were analyzed. The median rate of SB was 11% across studies. Seven factors (3 patient related and 4 procedure related) were recognized as predictors of early SB post-TAVI. Age ≥90 years (RR 1.17; p = 0.008), female (RR 1.13; p = 0.01), and sheath diameter >19 Fr (RR 1.19; p = 0.04) were weak predictors. Chronic kidney disease (RR 1.94; p <0.001) and transapical (TA) (RR 1.82; p <0.001) were moderate predictors that were almost associated with twofold risk. Vascular complication (RR 2.97; p <0.001) and circulatory support (RR 3.39; p <0.001) were strong predictors that were nearly associated with threefold risk. In conclusion, age, gender, chronic kidney disease, TA, sheath diameter, vascular complication, and circulatory support were all predictors of early SB post-TAVI in this meta-analysis, which provided possible guidance for prevention and management of SB related to TAVI., (Copyright © 2017 Elsevier Inc. All rights reserved.)

To date, the impact of diabetes mellitus (DM) on prognosis after transcatheter aortic valve implantation (TAVI) is still contradictory and thus merits further investigation. The purpose of this meta-analysis was to evaluate the impact of DM on outcomes after TAVI. A systematic search of the PubMed database was performed. Primary end points were 30-day and 1-year all-cause mortality after TAVI. Risk ratios (RRs) and 95% CIs were calculated using the random-effect or fixed-effect model, depending on heterogeneity between studies, and p values <0.05 was considered significant. A total of 16 studies involving 13,253 patients were included in our meta-analysis. There was no significant difference between the groups with DM and without DM regarding 30-day (RR 1.07, 95% CI 0.90 to 1.27, p = 0.45) or 1-year (RR 1.04, 95% CI 0.94 to 1.15, p = 0.42) all-cause mortality. The risks of 30-day complications, including myocardial infarction, stroke, major vascular complications, major bleeding, and acute kidney injury, were similar between patients with and without DM. In conclusion, DM neither affected short- or mid-term all-cause mortality nor short-term complications after TAVI., (Copyright © 2016 Elsevier Inc. All rights reserved.)