Outcomes for patients undergoing transcatheter aortic valve replacement with ascending aorta dilation.

BACKGROUND: We aim to compare the short and long-term outcomes for aortic stenosis (AS) patients undergone TAVR with and without ascending aorta dilation (AAD). METHODS: Consecutive patients diagnosed with native severe AS who underwent TAVR from September 2012 to September 2021 were enrolled. They were stratified into the moderate/severe dilation group (greatest ascending aorta width ≥ 45 mm) and the non/mild dilation group. Survival outcomes were illustrated using Kaplan-Meier curves and evaluated with the log-rank test. Data from patients with CT follow-up of >6 months was used to investigate the progression rate of AAD. RESULTS: The study cohort comprised 556 patients, with a mean age of 75.5 ± 7.3 years. Among them, 107 patients (19.2%) had a moderate/severe AAD (≥45 mm), with an average diameter of 48.6 mm (±2.8). During hospitalization, both groups witnessed two cases of ascending aortic dissection (1.9% vs 0.4%, P = 0.380). The median follow-up duration was 3.9 years (95% CI: 3.8-4.0 years). No deaths were caused by aortic events and no patients experienced a new aortic dissection. The AAD cohort's 4-year all-cause and cardiovascular mortality rates were not significantly different to the non/mild dilation group's (log-rank test, P = 0.109 and P = 0.698, respectively). Follow-up CT data revealed that the rate of aortic dilation progression in the moderate/severe dilation group was not significantly different from that in the non/mild group (0.0 mm/year, 25-75%th: -0.3-0.2 vs 0.1 mm/year, 25-75%th: -0.3-0.4, P = 0.122). CONCLUSION: This study found no significant difference regarding short-term and long-term outcomes in AS patients with/without moderate/severe AAD undergoing TAVR.

Prognostic effect of stress hyperglycemia ratio on patients with severe aortic stenosis receiving transcatheter aortic valve replacement: a prospective cohort study.

BACKGROUND: Stress hyperglycemia ratio (SHR) has recently been recognized as a novel biomarker that accurately reflects acute hyperglycemia status and is associated with poor prognosis of heart failure. We evaluated the relationship between SHR and clinical outcomes in patients with severe aortic stenosis receiving transcatheter aortic valve replacement (TAVR). METHODS: There were 582 patients with severe native aortic stenosis who underwent TAVR consecutively enrolled in the study. The formula used to determine SHR was as follows: admission blood glucose (mmol/L)/(1.59×HbA1c[%]-2.59). The primary endpoint was defined as all-cause mortality, while secondary endpoints included a composite of cardiovascular mortality or readmission for heart failure, and major adverse cardiovascular events (MACE) including cardiovascular mortality, non-fatal myocardial infarction, and non-fatal stroke. Multivariable Cox regression and restricted cubic spline analysis were employed to assess the relationship between SHR and endpoints, with hazard ratios (HRs) and 95% confidence intervals (CIs). RESULTS: During a median follow-up of 3.9 years, a total of 130 cases (22.3%) of all-cause mortality were recorded. Results from the restricted cubic spline analysis indicated a linear association between SHR and all endpoints (p for non-linearity > 0.05), even after adjustment for other confounding factors. Per 0.1 unit increase in SHR was associated with a 12% (adjusted HR: 1.12, 95% CI: 1.04-1.21) higher incidence of the primary endpoint, a 12% (adjusted HR: 1.12, 95% CI: 1.02-1.22) higher incidence of cardiovascular mortality or readmission for heart failure, and a 12% (adjusted HR: 1.12, 95% CI: 1.01-1.23) higher incidence of MACE. Subgroup analysis revealed that SHR had a significant interaction with diabetes mellitus with regard to the risk of all-cause mortality (p for interaction: 0.042). Kaplan-Meier survival analysis showed that there were significant differences in the incidence of all endpoints between the two groups with 0.944 as the optimal binary cutoff point of SHR (all log-rank test: p < 0.05). CONCLUSIONS: Our study indicates linear relationships of SHR with the risk of all-cause mortality, cardiovascular mortality or readmission for heart failure, and MACE in patients with severe aortic stenosis receiving TAVR after a median follow-up of 3.9 years. Patients with an SHR exceeding 0.944 had a poorer prognosis compared to those with lower SHR values.

Determinants of device success after transcatheter aortic valve replacement in patients with type-0 bicuspid aortic stenosis.

Background: Clinical evidence of transcatheter aortic valve replacement in patients with type-0 bicuspid aortic valve was relatively scarce. Aims: Our goal was to explore determinants of device success after transcatheter aortic valve replacement in patients with type-0 bicuspid aortic valve morphology. Methods: In this retrospective multicenter analysis, we included 59 patients with symptomatic severe aortic stenosis with type-0 bicuspid aortic valve morphology who underwent transcatheter aortic valve replacement. Type-0 bicuspid aortic valve was identified with multidetector computed tomography scans. The technical success rate was 89.8%, and the device success rate was 81.4%. Patients were divided into a device success group and a device failure group according to Valve Academic Research Consortium- 3 criteria. Results: When we compared the two groups, we found that the ellipticity index of the aortic root and the presence of bulky calcifications at the commissure were statistically different (ellipticity index 35.7 ± 1.7 vs. 29.7 ± 1.1, p = 0.018; bulky calcification at the commissure, 54.5% vs. 4.5%, p < 0.001). Further multivariate logistic analysis showed that bulky calcification at the commissure had a negative correlation with device success (odds ratio 0.030, 95% confidence interval 0.003-0.285, p = 0.002). Yet there was no statistical correlation between the ellipticity index and device success (odds ratio 0.818, 95% confidence interval 0.667-1.003, p = 0.053). Conclusions: The presence of bulky calcifications at the commissure is negatively correlated with device success after transcatheter aortic valve replacement in patients with type-0 bicuspid aortic valve.

Early 6 months usage of single anTiplAtelet OR anTicoAgulant followed by single antiplatelet after transcatheter aortic valve replacement: protocol for a multicentre, open-label, randomised controlled clinical trial.

INTRODUCTION: The strategy for initiating antithrombotic therapy to prevent bioprosthetic valve thrombosis (BPVT) after transcatheter aortic valve replacement (TAVR) remains uncertain. There is still lacking evidence on the efficacy and safety of early 6 months usage of single-antiplatelet therapy (SAPT) or oral anticoagulant (OAC) after TAVR in patients without anticoagulant indications. METHODS AND ANALYSIS: This is a multicentre, randomised controlled, open-label trial, and 650 patients undergoing TAVR from 13 top TAVR centres in China will be recruited. Each eligible participant will be randomly assigned to two groups (1:1 ratio) as (1) SAPT (aspirin 75-100 mg for 6 months) group or (2) OAC group (warfarin, therapeutic international normalised ratio at 1.8-2.5 for 6 months), both followed by sequential aspirin 75-100 mg for 6 months. Participants in both groups will be invited for three follow-up visits of 1, 6 and 12 months after discharge. We will use both the net clinical benefit endpoint (composite of all-cause mortality, myocardial infarction, stroke/transient ischaemic attacks, peripheral artery thrombosis, intracardiac thrombosis and major bleeding and disabling or life-threatening bleeding) and the BPVT endpoint evaluated by four-dimensional CT as our primary endpoints. P value of <0.05 of two-sided test will be considered statistically significant. ETHICS AND DISSEMINATION: The present study was approved by the Institutional Review Boards at Fuwai Hospital, National Center for Cardiovascular Diseases of China (Approval No. 2023-1947). All patients will be informed of the details of the study and will sign an informed consent prior to inclusion in the study. Results of this study will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05375474.

Development and validation of a deep learning-based fully automated algorithm for pre-TAVR CT assessment of the aortic valvular complex and detection of anatomical risk factors: a retrospective, multicentre study.

BACKGROUND: Pre-procedural computed tomography (CT) imaging assessment of the aortic valvular complex (AVC) is essential for the success of transcatheter aortic valve replacement (TAVR). However, pre-TAVR assessment is a time-intensive process, and the visual assessment of anatomical structures at the AVC shows interobserver variability. This study aimed to develop and validate a deep learning-based algorithm for pre-TAVR CT assessment and anatomical risk factor detection. METHODS: This retrospective, multicentre study used AVC CT scans to develop a deep learning-based, fully automated algorithm, which was then internally and externally validated. After loading CT scans into the algorithm, it automatically assessed the essential anatomical structure data required for TAVR planning. CT scans of 1252 TAVR candidates continuously enrolled from Fuwai Hospital were used to establish training and internal validation datasets, while CT scans of 100 patients with aortic valve disease across 19 Chinese hospitals served as an external validation dataset. The validation focused on segmentation performance, localisation and measurement accuracy of key anatomical structures, detection ability of specific anatomical risk factors, and improvement in assessment efficiency. FINDINGS: Relative to senior observers, our algorithm achieved significant consistent performance with remarkable accuracy, efficiency and ease in segmentation, localisation, and the assessment of the aortic annulus perimeter-derived diameter, and other basic planes, coronary ostia height, calcification volume, and aortic angle. The intraclass correlation coefficient values for the algorithm in the internal and external validation datasets were up to 0.998 (95% confidence interval 0.998-0.998), respectively. Furthermore, the algorithm demonstrated high alignment in detecting specific anatomical risk factors, with accuracy, sensitivity, and specificity up to 0.989 (95% CI 0.973-0.996), 0.979 (95% CI 0.936-0.995), 0.986 (95% CI 0.945-0.998), respectively. INTERPRETATION: Our algorithm efficiently performs pre-TAVR assessments by using AVC CT imaging with accuracy comparable to senior observers, potentially improving TAVR planning in clinical practice. FUNDING: National Key R&D Program of China (2020YFC2008100), CAMS Innovation Fund for Medical Sciences (2022-I2M-C&T-B-044).

Computed tomography anatomical characteristics based on transcatheter aortic valve replacement in aortic regurgitation.

This study analyzed computed tomography (CT) measurement characteristics and anatomical classifications based on transcatheter aortic valve replacement (TAVR) in patients with aortic regurgitation (AR) to establish a preliminary summary of CT anatomical characteristics and to design a novel self-expanding transcatheter heart valve (THV). This single-center retrospective cohort study included 136 patients diagnosed with moderate-to-severe AR at Fuwai Hospital from July 2017 to April 2022. Patients were classified into four anatomical classifications according to dual-anchoring multiplanar measurement of where THV anchoring took place. Types 1-3 were considered candidates for TAVR, whereas type 4 was not. Among 136 patients with AR, there were 117 (86.0%) tricuspid, 14 bicuspid, and five quadricuspid valves. Dual-anchoring multiplanar measurement showed that the annulus was smaller than left ventricular outflow tract (LVOT) at 2, 4, 6, 8, and 10 mm on the annulus. The ascending aorta (AA) 40 mm was wider than AA 30 mm and AA 35 mm, but narrower than AA 45 mm and AA 50 mm. For 10% oversize of the THV, the proportions of the annulus, LVOT, and AA unable to meet the diameter were 22.8%, 37.5%, and 50.0%, respectively, and the proportions of anatomical classification types 1-4 were 32.4%, 5.9%, 30.1%, and 31.6%, respectively. The novel THV could significantly improve the type 1 proportion (88.2%). Existing THVs cannot meet the anatomical characteristics of patients with AR. Conversely, based on anatomical characteristics, the novel THV could theoretically facilitate TAVR.

Can Measuring the 'Dual Anchors of Aorta' Enhance the Success Rate of TAVR?-A Single-Center Experience.

INTRODUCTION: Chronic severe aortic regurgitation (AR) has a poor long-term prognosis, especially among old-age patients. Considering their advancing age, the surgical approach of aortic valve replacement may not always be the best alternative modality of treatment in such patients. Therefore, this study's primary goal was to provide an initial summary of the medium- and short-term clinical effectiveness of transcatheter aortic valve replacement (TAVR) guided by accurate multi-detector computed tomography (MDCT) measurements in patients with severe and chronic AR, especially in elderly patients. METHODS: The study enrolled retrospectively and prospectively patients diagnosed with severe AR who eventually underwent TAVR procedure from January 2019 to September 2022 at Fuwai cardiovascular Hospital, Beijing. Baseline information, MDCT measurements, anatomical classification, perioperative, and 1-year follow-up outcomes were collected and analyzed. Based on a novel anatomical categorization and dual anchoring theory, patients were divided into four categories according to the level of anchoring area. Type 1, 2, and 3 patients (with at least two anchoring regions) will receive TAVR with a transcatheter heart valve (THV), but Type 4 patients (with zero or one anchoring location) will be deemed unsuitable for TAVR and will instead receive medical care (retrospectively enrolled patients who already underwent TAVR are an exception). RESULTS: The mean age of the 37 patients with severe chronic AR was 73.1 ± 8.7 years, and 23 patients (62.2%) were male. The American Association of Thoracic Surgeons' score was 8.6 ± 2.1%. The MDCT anatomical classification included 17 cases of type 1 (45.9%), 3 cases of type 2 (8.1%), 13 cases of type 3 (35.1%), and 4 cases of Type 4 (10.8%). The VitaFlow valve (MicroPort, Shanghai, China) was implanted in 19 patients (51.3%), while the Venus A valve (Venus MedTech, Hangzhou, China) was implanted in 18 patients (48.6%). Immediate TAVR procedural and device success rates were 86.5% and 67.6%, respectively, while eight cases (21.6%) required THV-in-THV implantation, and nine cases (24.3%) required permanent pacemaker implantation. Univariate regression analysis revealed that the major factors affecting TAVR device failure were sinotubular junction diameter, THV type, and MDCT anatomical classification (p < 0.05). Compared with the baseline, the left ventricular ejection fraction gradually increased, while the left ventricular end-diastolic diameter remained small, and the N-terminal-pro hormone B-type natriuretic peptide level significantly decreased within one year. CONCLUSION: According to the results of our study, TAVR with a self-expanding THV is safe and feasible for patients with chronic severe AR, particularly for those who meet the criteria for the appropriate MDCT anatomical classification with intact dual aortic anchors, and it has a significant clinical effect for at least a year.

The effects of levosimendan in patients undergoing transcatheter aortic valve replacement- a retrospective analysis.

Background: Aortic stenosis (AS) increases left ventricular afterload, leading to cardiac damage and heart failure (HF). Transcatheter aortic valve replacement (TAVR) is an effective therapy for AS. No inotropic agents including levosimendan have been evaluated in patients undergoing TAVR. Methods: A total of 285 patients underwent TAVR between 2014 and 2019; 210 were included in the matched analysis and 105 received 0.1 µg/kg body weight/min levosimendan immediately after the prosthesis had been successfully implanted. Medical history, laboratory tests, and echocardiography results were analyzed. Endpoints including 2-year all-cause mortality, stroke, or HF-related hospitalization, and a combination of the above were analyzed by Cox proportional hazard models. Results: The levosimendan group had no difference in 2-year mortality compared with the control group (hazard ratio [HR]: 0.603, 95% confidence interval [CI]: 0.197-1.844; p = 0.375). However, levosimendan reduced stroke or HF-related hospitalization (HR: 0.346; 95% CI: 0.135-0.884; p = 0.027) and the combined endpoint (HR: 0.459, 95% CI: 0.215-0.980; p = 0.044). After adjusting for multiple variants, levosimendan still reduced stroke or HF-related hospitalization (HR: 0.346, 95% CI: 0.134-0.944; p = 0.038). Conclusion: Prophylactic levosimendan administration immediately after valve implantation in patients undergoing TAVR can reduce stroke or HF-related hospitalization but does not lower all-cause mortality.

A novel anatomic classification to guide transcatheter aortic valve replacement for pure aortic regurgitation.

BACKGROUND: The success of transcatheter aortic valve replacement (TAVR) in native aortic regurgitation (AR) is limited by the absence of calcified anchoring structures. We sought to evaluate transfemoral TAVR in patients with native AR using a novel aortic root imaging classification. METHODS: From March to November 2021, 81 patients with severe AR were prospectively enrolled in 2 cardiac centers in China. All were evaluated using multidetector computed tomography (MDCT) and classified into 4 anatomic types in reference to transcatheter heart valve (THV) anchoring: Type 1: anchoring at the left ventricular outflow tract (LVOT), annulus, and ascending aorta (AA); Type 2: anchoring at the annulus and AA; Type 3: anchoring at the annulus and LVOT; and Type 4: anchoring at only 1 level or none at all. Based on the dual-anchoring strategy, patients with Types 1-3 were considered TAVR candidates. Procedural and 30-day outcomes were assessed according to Valve Academic Research Consortium-3 definitions. RESULTS: TAVR was performed in 32 (39.5%) patients (71.9 ± 8.0 years of age, 71.9% were male) using 2 self-expanding THVs. Types 1, 2, and 3 comprised 13 (40.6%), 11 (34.4%), and 8 (25.0%) cases, respectively. The procedural and device success rates were 100% and 93.8%, respectively, with 2 THV migration. Eight patients (25.0%) required a permanent pacemaker, and 2 (6.3%) developed moderate paravalvular leaks. No deaths or other major complications occurred during the study. CONCLUSIONS: The novel anatomic classification and dual-anchoring strategy were associated with a high procedural success rate with favorable short-term safety and clinical outcomes.

Prior percutaneous coronary intervention and outcomes in patients after coronary artery bypass grafting: a meta-analysis of 308,284 patients.

Background: The association between prior percutaneous coronary intervention (PCI) and prognosis after coronary artery bypass grafting (CABG) remains uncertain. We aimed to evaluate the aforementioned association in a meta-analysis. Methods: PubMed, Cochrane's Library, and Embase databases were searched for potential studies. A random-effects model was used for the meta-analysis. Meta-regression was performed to evaluate the influence of study characteristics on the outcomes. Results: Thirty-six follow-up studies with 308,284 patients were included, and 40,892 (13.3%) patients had prior PCI. Pooled results showed that prior PCI was associated with higher risks of early (in-hospital or within 1 month) all-cause mortality [odds ratio (OR): 1.26, 95% confidence interval (CI): 1.11-1.44, p = 0.003; I 2 = 64%] and major adverse cardiovascular events (MACEs; OR: 1.36, 95% CI: 1.12-1.66, p = 0.002, I 2 = 79%), but not with late (follow-up durations from 1 to 13 years) mortality (OR: 1.03, 95% CI: 0.95-1.13, p = 0.44, I 2 = 46%) or MACEs (OR: 1.03, 95% CI: 0.97-1.09, p = 0.38, I 2 = 0%). Meta-regression showed that the study characteristics of patient number, age, sex, diabetic status, and proportion of patients with prior PCI did not affect the outcomes. Sensitivity analyses limited to multivariate studies excluding patients with acute PCI failure showed similar results (early mortality, OR: 1.25, p = 0.003; early MACE, OR: 1.50, p = 0.001; late mortality, OR: 1.03, p = 0.70). Conclusion: The current evidence, mostly from retrospective observational studies, suggests that prior PCI is related to poor early clinical outcomes, but not to late clinical outcomes, after CABG.

Twelve-month outcomes of the TaurusOne valve for transcatheter aortic valve implantation in patients with severe aortic stenosis.

BACKGROUND: In the last decade, transcatheter aortic valve implantation (TAVI) has developed rapidly in China. As TAVI progresses towards low surgical risk patients, the total number of TAVI procedures will grow exponentially. There is a need to develop a domestic TAVI device designed for Chinese patients. AIMS: The aim of this study was to evaluate the safety and efficacy of a self-expanding valve (TaurusOne transcatheter aortic valve system) in the treatment of patients with symptomatic severe aortic stenosis in China. METHODS: A prospective, multicentre, single-arm study was designed to enrol 120 patients with symptomatic severe aortic stenosis undergoing TAVI using the TaurusOne valve. The primary endpoint was all-cause mortality at one year. RESULTS: From September 2017 to April 2019, 120 patients were enrolled (35% bicuspid aortic valve, mean Society of Thoracic Surgeons [STS] score 9.95%). One-year mortality in 120 patients (follow-up rate, 100%), was 6.7% (upper 95% confidence interval: 12.9%), which was significantly lower than the performance goal of 30% (p<0.0001). All stroke, myocardial infarction, paravalvular leak ≥moderate, and new pacemaker implantation occurred in 4.4%, 1.8%, 0.8%, and 22.1% of patients, respectively, at one year. The haemodynamic results and quality of life scores also improved significantly. Patients with a bicuspid valve had similar outcomes to those with a tricuspid aortic valve. CONCLUSIONS: The one-year clinical results confirm the safety and efficacy of the TaurusOne transcatheter aortic valve system in the treatment of patients with symptomatic severe tricuspid and bicuspid aortic stenosis.

Anatomical morphology of the aortic valve in Chinese aortic stenosis patients and clinical results after downsize strategy of transcatheter aortic valve replacement.

BACKGROUND: The study aimed to describe the aortic valve morphology in Chinese patients underwent transcatheter aortic valve replacement (TAVR) for symptomatic severe aortic stenosis (AS), and the impact of sizing strategies and related procedural outcomes. METHODS: Patients with severe AS who underwent TAVR were consecutively enrolled from 2012 to 2019. The anatomy and morphology of the aortic root were assessed. "Downsize" strategy was preformed when patients had complex morphology. The clinical outcomes of patients who performed downsize strategy were compared with those received annular sizing strategy. The primary outcome was device success rate, and secondary outcomes included Valve Academic Research Consortium-3 clinical outcomes variables based on 1-year follow-up. RESULTS: A total of 293 patients were enrolled. Among them, 95 patients (32.4%) had bicuspid aortic valve. The calcium volume (Hounsfield Unit-850) of aortic root was 449.90 (243.15-782.15) mm 3 . Calcium is distributed mostly on the leaflet level. Downsize strategy was performed in 204 patients (69.6%). Compared with the patients who performed annular sizing strategy, those received downsize strategy achieved a similar device success rate (82.0% [73] vs . 83.3% [170], P  = 0.79). Aortic valve gradients (downsize strategy group vs . annular sizing group, 11.28 mmHg vs. 11.88 mmHg, P  = 0.64) and percentages of patients with moderate or severe paravalvular regurgitation 2.0% (4/204) vs . 4.5% (4/89), P  = 0.21) were similar in the two groups at 30 days after TAVR. These echocardiographic results were sustainable for one year. CONCLUSIONS: Chinese TAVR patients have more prevalent bicuspid morphology and large calcium volume of aortic root. Calcium is distributed mostly on the leaflet level. Compare with annular sizing strategy, downsize strategy provided a non-inferior device success rate and transcatheter heart valve hemodynamic performance in self-expanding TAVR procedure.

The feasibility and safety of "one-stop" left atrial appendage closure and percutaneous coronary intervention in atrial fibrillation patients with significant coronary artery disease (PCI-LAAC study).

BACKGROUND: The anti-thrombotic strategy for patients with atrial fibrillation (AF) who have undergone percutaneous coronary intervention (PCI) for coronary artery disease (CAD) is a common and difficult challenge. This pilot study aimed to assess the feasibility and safety of "one-stop" left atrial appendage closure (LAAC) combined with PCI as an alternative stroke prophylaxis strategy. METHODS: From March 2017 to October 2019, AF patients with elevated bleeding risk and significant stable CAD requiring PCI were recruited to undergo LAAC as alternative stroke prophylaxis in Fuwai Hospital, Beijing, China. LAAC was performed either in the same setting with PCI (i.e. "one-stop" LAAC/PCI), or as staged procedure after PCI. Dual antiplatelet therapy was given for all patients after LAAC. Peri-procedural and intermediate-term clinical outcomes were assessed through hospital clinical records review and standardized telephone interviews. RESULTS: A total of 24 patients were recruited including 13 (54.2%) underwent stage procedure and 11 (45.8%) underwent "one-stop" procedure respectively. The mean CHA2DS2-VASc and HAS-BLED scores were 4.5±1.4 and 3 (IQR 3,4) respectively. Six patients (46.1%) in the staged procedure cohort were treated with triple anti-thrombotic following PCI, with 2 developed minor bleeding before LAAC. One patient ("one-stop" cohort) had gastrointestinal bleeding 1 day after procedure. Otherwise, there was no device related complication or peri-procedural stroke/myocardial infarction. After a mean 19±5.4 months follow-up, there was no death, myocardial infarction, stroke and systemic embolization detected. CONCLUSIONS: In this pilot study, "one-stop" LAAC with PCI was shown to be efficacious with no stroke, MI, VARC-2 major bleeding or CV death reported over a mean follow-up of 19 months, and safe with no major peri-procedural bleeding or device related complications.

Comprehensive Geriatric Assessment and Exercise Capacity in Cardiac Rehabilitation for Patients Referred to Transcatheter Aortic Valve Implantation.

Comprehensive geriatric assessment (CGA)-based cardiac rehabilitation (CR) program is essential for patients before and after transcatheter aortic valve implantation (TAVI). This study aimed to explore the values of CGA and exercise capacity in CR for patients referred to TAVI. A retrospective analysis was conducted in 90 patients referred to TAVI from January to October 2019. CR strategies started before TAVI. The association between clinical characteristics, CGA, and change in six-minute walk distance (Δ6MWD) was analyzed with multivariate regression models. Most of patients had cognitive impairment (50%), malnutrition (61%), and frailty (83%). After the CR, the proportion of cognitive impairment, malnutrition, and frail patients was significantly decreased by 21%, 40%, and 57%, respectively (p = 0.002, p <0.001, p <0.001). The 6MWD at a month after discharge (291.9 ± 98.8 m) was significantly improved than that at discharge after TAVI (218.8 ± 114.3m, p <0.001). The multivariate regression analysis indicated body mass index (BMI; Δ6MWD:12.0, 95% confidence interval [CI] 0.3 to 23.8, p = 0.045), frailty (Δ6MWD: -57.9, 95% CI -81.8 to -34.1, p <0.001) and malnutrition (Δ6MWD: -25.1, 95% CI -47.0 to -3.2, p = 0.026) as the associated predictors of Δ6MWD. In conclusion, functional status in patients referred to TAVI could be improved by CGA-based CR. BMI, frailty, and malnutrition were associated with the efficacy of CR on exercise capacity. CGA can play the important role in the evaluation and making strategies for CR in patients.

Preprocedural circulating galectin-3 and the risk of mortality after transcatheter aortic valve replacement: a systematic review and meta-analysis.

BACKGROUND: Galectin-3 may predict mortality for patients with aortic stenosis (AS) after transcatheter aortic valve replacement (TAVR). However, the results were inconsistent. We aimed to evaluate the association between baseline galectin and mortality after TAVR in a meta-analysis. METHODS: Related follow-up studies were obtained by systematic search of PubMed, Cochrane's Library, and Embase databases. Both the fixed- and the random-effect models were used for the meta-analysis. Subgroup analyses were performed to evaluate the influences of study characteristics on the outcome. RESULTS: Five prospective cohort studies with 854 patients were included, with a follow-up period between 1 and 1.9 years. Patients with higher baseline circulating galectin-3 had an increased risk of all-cause mortality after TAVR (random-effects model: risk ratio [RR]: 1.63, 95% confidence interval [CI]: 1.19-2.23, P=0.002; fixed-effects model: RR: 1.62, 95% CI: 1.19-2.20, P=0.002; I2 = 4%). Adjustment of estimated glomerular filtration rate (RR: 1.73, P=0.02) or B-type natriuretic peptide (BNP) or N-terminal pro-BNP (RR: 1.83, P=0.02) did not significantly affect the result. A trend of stronger association between higher baseline circulating galectin-3 and increased risk of all-cause mortality after TAVR was observed in studies with an enzyme-linked fluorescent assay (ELFA) (RR: 3.04, P=0.003) compared with those with an enzyme-linked immunosorbent assay (ELISA) (RR: 1.42, P=0.04; P for subgroup difference =0.06). CONCLUSION: Higher circulating galectin-3 before the procedure may predict all-cause mortality of AS patients after TAVR.

Optimal pre-TAVR annulus sizing in patients with bicuspid aortic valve: area-derived perimeter by CT is the best-correlated measure with intraoperative sizing.

OBJECTIVE: To clarify the optimal measurements for patients with bicuspid aortic valve (BAV) preferred for transcatheter aortic valve replacement (TAVR), our study compared intraoperative sizing with five different approaches by transthoracic echocardiography (TTE), three-dimensional transesophageal echocardiography (3DTEE) and computed tomography (CT). METHODS: We enrolled 104 BAV patients prescreened for TAVR but who underwent surgery with direct intraoperative annulus sizing. All five approaches [2DTTE, 3DTEE, area-derived perimeter (CTarea), perimeter-derived diameter (CTperi) and mean diameter (CTmean)] were compared with intraoperative sizing, respectively. Agreements on theoretical valve selections by five methods with those by intraoperative sizing were analyzed. RESULTS: CTarea showed the highest correlation (r = 0.932) and the best agreement with intraoperative sizing. Agreement for theoretical surgical and TAVR prosthesis selection was found in 84.6% and 74.0% BAVs by CTarea (κ = 0.791, κ = 0.585). CTperi-based prosthesis selection led to overestimation of 26.9% for surgical valves (κ = 0.589) and 36.5% for TAVR valves (κ = 0.425). Good correlations were observed between CT measurements and intraoperative sizing regardless of the predominant site of aortic valve calcification (r = 0.860-0.953). CONCLUSION: The CTarea, which demonstrated the optimal approach to annulus sizing and prosthesis choice of BAVs with high eccentricity, should be included into the BAV-specific annulus sizing recommendation. The insufficiency of CTperi lay in overestimation of surgical or TAVR valve selections. Good agreement of 3DTEE sizing proved its superiority in annulus sizing for BAVs unsuitable for CT, but it should be used with caution for patients with a calcified annulus, where partial acoustic shadowing could lead to image inaccuracy. KEY POINTS: • The area-derived perimeter by CT is the optimal approach to annulus sizing of BAVs. • The perimeter-derived approach is prone to overestimation of BAVs. • 3DTEE showed its superiority in annulus sizing for BAVs unsuitable for CT, but it should be used with caution in patients with a calcified annulus.

Imaging Evaluation for the Detection of Leaflet Thrombosis After Transcatheter Aortic Valve Replacement.

Subclinical leaflet thrombosis has been increasingly recognized as a common imaging finding after surgical or transcatheter aortic valve replacement (TAVR) in recent studies. This finding has raised concerns over TAVR valve durability and debates on optimal postprocedural antithrombotic regime. Hypoattenuated leaflet thickening (HALT) and the associated reduced leaflet motion (RELM) were noted as computed tomography hallmarks of the phenomenon. The coexistence of HALT and significant RELM has been suggested as a threshold for reporting of subclinical leaflet thrombosis. This methodology may contribute to the standardization of reporting for research collaboration, hence the better understanding and management of this common yet largely unknown phenomenon.

Characteristics of aorto-iliofemoral arterial tree according to aortic valve morphology in chinese patients considered for TAVR.

To characterize the anatomy of aorto-iliofemoral arterial tree according to aortic valve phenotype by CT in patients referred for transcatheter aortic valve replacement (TAVR). We retrospectively enrolled 215 patients screened for TAVR who underwent CT. Dimensions, calcification, vascular tortuosity index score and other putative risk features of 13 different regions were evaluated for bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV) morphology. The study consisted of 44% BAVs with younger age than TAVs. The dimensions of the annulus, sinus of Valsalva, ascending aorta and aortic arch were consistently larger in BAVs. The prevalence of calcification of aortic arch was significantly higher in TAVs even after adjustment for atherosclerotic risk factors. BAVs was associated with two-fold higher odds of having over I degree AA calcification (odds ratio 2.02; 95% CI 1.60-5.31; p < 0.001). The prevalence of severe iliac tortuosity was higher among BAVs (11.7 vs. 2.5%, p = 0.015). BAVs had a trend to more atheroma than TAVs in the abdominal aortic artery and iliofemoral artery. BAV anatomy is common in Chinese AS patients screened for TAVR. Aorto-iliofemoral pathology varies according to aortic valve phenotype, which may contribute to technical challenges in BAV vs. TAV anatomy and support the need for the integrated risk assessment for each valve phenotype.

Morphological characteristics of severe aortic stenosis in China: imaging corelab observations from the first Chinese transcatheter aortic valve trial.

OBJECTIVES: We sought to describe the morphological characteristics of aortic valve disease in a Chinese population presenting for transcatheter aortic valve replacement (TAVR). BACKGROUND: Racial and regional differences are known to exist in aortic stenosis (AS), but limited data exist comparing the specific anatomical variations between populations. METHODS: Patients were prospectively evaluated in a Chinese population presenting for TAVR in the Venus A-Valve trial, the first trial evaluating TAVR in China. A systematic anatomical assessment protocol employed contrast-enhanced computed tomography (CT) in all the cases. RESULTS: A total of 120 consecutive patients were studied. Of these, 61 (50.7%) were patients with tricuspid, 57 (47.5%) bicuspid, and 2 (1.7%) unicuspid valve morphologies. Of the 57 cases with bicuspid valve, 31 (54.4%) had no raphe (Sievers classification, type 0) and 26 (45.6%) were of raphe type. Although the incidence of bicuspid valve morphology was more than a third in the northern Chinese population, this was lower than the eastern Chinese population (P = 0.035), in whom the incidence was more than half. A comparison of tricuspid morphologies in China versus a Western series of 229 consecutive patients undergoing TAVR assessed with CT showed a threefold excess of leaflet calcium burden in China, with a leaflet calcium volume of 421 mm(3) (IQR, 188-688 mm(3) ) versus 142 mm(3) (IQR, 58-267 mm(3) ). CONCLUSIONS: Patients presenting for TAVR in China have a very high frequency of bicuspid valve morphology. Even in tricuspid disease, there are clear differences to Western patients, with a high calcium burden, which presents challenges for TAVR in this population (ClinicalTrials.gov NCT01683474).