One-Year Outcomes of “off-label” Transcatheter Devices in Native Aortic Regurgitations

One-Year Outcomes of “off-label” Transcatheter Devices in Native Aortic Regurgitations | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article One-Year Outcomes of “off-label” Transcatheter Devices in Native Aortic Regurgitations Xiaoqin Tang, Sanjiu Yu, Chaojun Yan, Ruihan Xiao, Xin Xie, Huajie Zheng, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7001587/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background In mainland China, there is a lack of “on-label” transfemoral aortic valves for aortic regurgitation (AR). Consequently, this study sought to assess the safety and feasibility of “off-label” TAVR devices in AR patients. Methods This was a retrospective study utilizing our institutional TAVR database between January 2020 and June 2024. The study compared outcomes of “off-label” TAVR devices in patients with isolated aortic stenosis (AS) vs patients with pure native AR (moderate or greater). The outcome measure was 1-year all-cause mortality, the incidence of major adverse events (MAEs) and the New York Heart Association (NYHA) functional improvement. Results Total 445 consecutive patients received transfemoral TAVR treatment for aortic valve disease at our department, of which 177 were excluded due to concomitant severe comorbidities and other special situations. No inter-group statistical differences were found in basic patient characteristics. The 1-year all-cause mortality rate, cardiovascular mortality, new permanent pacemaker implantation, valve-related reintervention, PVL (moderate or greater) was higher in the AR group than in the AS group,but there were no significant differences among these parameters. And the incidence of composite MAE (7.02% AS vs 5.89% AR) and the NHNA classifications ≤ II (84.11% AS vs 84.15% AR) were similar. LVEF, LV, IVST and LVPWT improved in both groups, except that the former two improved more significantly in AR group and the latter two improved more significantly in AS group, which may be attributed to both pathophysiologic features. Conclusions This single-center study demonstrated the short-term safety and feasibility of the “off-label” TAVR device in patients with AR. In addition, it showed different degrees of improvement in LV structural and functional parameters in the two groups, which may be attributed to both pathophysiologic features. transcatheter aortic valve replacement aortic regurgitation aortic stenosis clinical outcome left ventricular functio Figures Figure 1 Figure 2 Figure 3 1. Introduction Valvular heart disease is a leading cause of disability, deteriorating quality of life, and cardiovascular morbidity and mortality worldwide [ 1 ]. In developed countries, aortic valve disease accounts for 61% of all valvular heart disease deaths, while mitral valve disease accounts for 15% [ 2 ]. Over the past two decades, Transcatheter aortic valve replacement (TAVR) has changed the treatment paradigm for symptomatic severe AS, representing a minimally invasive alternative to surgery [ 3 ]. Recently, two landmarks randomized controlled trials, PARTNER 3 and EVOLUT Low Risk have confirmed that TAVR has better outcomes compared to SAVR, even in patients with symptomatic AS and lower surgical risk [ 4 – 6 ]. Consequently, TAVR has revolutionized the treatment of aortic stenosis (AS) and is now approved for patients of all risk profiles with severe symptomatic AS [ 3 ]. Although TAVR is indicated for native severe AS, it has also been performed in select patients for other indications, such as bicuspid aortic valve disease, failed surgical bioprosthetic valve, and aortic regurgitation (AR). There are few TAVR valves specially designed to treat AR. In mainland China, there is a lack of “on-label” transfemoral aortic valves for AR. Previous studies have reported the feasibility and outcomes of the “off-label” use of transfemoral transcatheter aortic valves for the treatment of patients with purely autologous AR (PNAR) [ 7 – 9 ]. There was no head-to-head study to compare their performance in TAVR for AS or AR. Therefore, this retrospective study aims to evaluate the safety and feasibility of an “off-label” TAVR device in patients with AR, compared to control group of patients treated with TAVR for AS. Therefore, this retrospective study aims to assess the safety and feasibility of off-label TAVR devices in pure native AR patients with a control group of patients treated with TAVR for AS. 2. Patients and Methods 2.1 Study design This study is a retrospective analysis of the clinical outcomes of TAVR in patients with AS and AR. Data was collected from all consecutive patients who underwent TAVR at our center from January 2020 and June 2024. A detailed list of specific inclusion criteria and exclusion criteria is shown in Table 1. Upon admission, each patient underwent a comprehensive clinical examination, laboratory tests, and transthoracic echocardiography (TTE). TTE was also used routinely during each TAVR. Definitions and terminology were harmonized with those employed in the STS/ACC Transcatheter Valve Therapy Registry. Comprehensive clinical and echocardiographic assessments were performed for all included patients before the procedure, upon discharge, and at 6 and 12 months post-discharge. All patients were followed up postoperatively through telephone calls or direct interviews, and all completed the 1-year follow-up. This study was conducted in accordance with the principles of good clinical practice and the Helsinki Declaration, and was approved by the Ethics Committee of Southwest Hospital (KY2024319). Table 1. Inclusion Criteria and Exclusion Criteria. AS Inclusion Criteria: Adult subjects with severe or moderate-to-severe AS as defined by the multiparametric approach of the American Society of Echocardiography (ASE) [10]; Symptomatic patients (Age ≥ 65 years) with clinical symptoms such as chest tightness, shortness of breath, chest pain, and dizziness caused by valvular disease; Or symptomatic patients (Age ≥ 80 years) with severe AS or for younger patientswith a life expectancy < 10 years; Or asymptomatic patients (Age ≤ 80 years) with severe AS and an LVEF < 50%; Or patients have contraindications for surgical intervention or are at high risk, or have other risk factors such as previous chest radiotherapy, liver failure, diffuse severe aortic calcification, or extreme frailty [11]; New York Heart Association (NYHA) functional class ≥ II and expected postoperative survival > 1 year. Suitable anatomy to accommodate the insertion and delivery of the Heart Valve System. Use of the transfemoral approach. Exclusion Criteria: Presence of a concomitant AR. Patients with degeneration of surgical bioprosthetic valves. Patients with severe comorbidities, such as acute aortic dissection, infection, severe coagulopathy, and multi-organ failure. AR Inclusion Criteria: Adult subjects with moderate-to-severe or severe AR as defined by the multiparametric approach of the American Society of Echocardiography (ASE) [10]. Symptomatic patients (Age ≥ 65 years) who are contraindicated for or at high risk of surgical intervention, and are expected to achieve clinical benefit from the treatment. Or asymptomatic patients (Age ≥ 65 years) with contraindications or high risk of surgical intervention, and expected to achieve clinical benefits from treatment, must meet at least one of the following criteria: left ventricular end-diastolic dimension (LVEDD) >70 mm, left ventricular end-systolic dimension (LVESD) >50 mm, left ventricular end-systolic dimension index >25 mm/m², LVEF ≤55% [11]. NYHA functional class ≥ II and expected postoperative survival > 1 year. Suitable anatomy to accommodate the insertion and delivery of the Heart Valve System. Use of the transfemoral approach. Exclusion Criteria: The presence of a concomitant moderate to severe AS. Patients with degeneration of surgical bioprosthetic valves; Patients with severe comorbidities, such as acute aortic dissection, infection, severe coagulopathy, and multi-organ failure 2.2 TAVR procedure The multidisciplinary heart team, comprising an interventional cardiologist, cardiovascular surgeon, echocardiographer, and anesthesiologist, decided to perform TAVR. Procedures have been previously described [12]. Patients received self-expanding valves, including VitaFlow (Microport) and Taurus One-Valve (Peijia Medical). Valve sizing relied on MDCT. Transfemoral access was preferred in all patients. Post-TAVR, dual antiplatelet therapy (aspirin 100 mg and clopidogrel 75 mg) was administered in nearly all cases. Where indicated, warfarin or novel oral anticoagulants were used. 2.3 Study endpoints The primary safety study endpoint was the all-cause mortality rate at 1 year post-discharge, as well as the composite rate of MAE including valve displacement, cardiovascular events, and stroke. The secondary efficacy study endpoint was the proportion of patients with a the cardiac function NYHA classifications II or better (NYHA classifications ≤ II), as assessed by clinicians combining echocardiographic results and clinical manifestations at 1-year post-discharge. Other study endpoints included echocardiographic assessments at admission, before discharge, and at 6 and 12 months post-discharge. Data were collected from our institutional database, consisting primarily of preoperative and perioperative information and postoperative outcomes. Regarding postoperative follow-up, data were gathered via examination of medical records or by engaging in telephone conversations with patients. 2.4 Statistical analysis Statistical analysis is performed using statistical software (SPSS version 23.0, IBM, New York, NY). For normally distributed data, continuous variables are expressed as mean ± standard deviation (SD). Categorical data are reported as frequencies and percentages. The Shapiro-Wilk test is used to test for normality of continuous variables, while the non-parametric Mann-Whitney U test is used to analyze continuous variables that are not normally distributed. Chi-square or Fisher's exact test is used to compare categorical variables between groups. P < 0.05 is considered statistically significant. 3. Results 3.1 Baseline characteristics Between January 2020 and June 2024, 445 consecutive patients received transfemoral TAVR treatment for aortic valve disease at our department, of which 177 were excluded due to patients with AS and concomitant AR (moderate or greater), etc., as shown in Fig. 1 . Of the remaining 278 patients, 155 had AS (age: 71.12 ± 4.84, 45.76% female), and 123 had AR (age: 70.14 ± 5.12, 42.27% female). There was no significant difference between the two groups in terms of age, race, diabetes, hypertension, chronic lung diseases, peripheral vascular disease, and coronary artery disease history. Simultaneously, 80% of the patients had the cardiac function NYHA classifications ≥ III in both groups. A detailed description of the specific characteristics of the patients is listed in Table 2 . Table 2 Baseline Clinical Characteristics AS(n = 155) AR(n = 123) p value Age, y 71.12 ± 4.84 70.14 ± 5.12 0.24 Sex (female) 81 (45.76) 52 (42.27) 0.10 Body mass index, kg/m2 23.15 ± 3.12 24.01 ± 2.85 0.33 Diabetes 18 (11.61) 8 (6.50) 0.15 Hypertension 52 (33.55) 51 (41.46) 0.17 Chronic pulmonary disease 14 (9.03) 14 (11.38) 0.65 Chronic renal dysfunction 23 (14.84) 22 (17.89) 0.66 Prior cerebrovascular accident 2 (1.29) 4 (3.25) 0.26 Atrial fibrillation 13 (8.39) 11 (8.94) 0.87 Coronary artery disease 79 (50.97) 60 (48.78) 0.72 Prior myocardial infarction 0 2 (1.63) 0.11 Peripheral arterial disease 58 (37.42) 44 (35.77) 0.78 Anemia 29 (18.71) 17 (13.82) 0.28 Prior PCI 0 2 (1.63) 0.11 Prior CABG 0 0 >0.99 Prior mitral valve surgery 2 (1.29) 1 (0.81) 0.70 Prior permanent pacemaker implantation 2 (1.29) 0 0.21 Logistic EuroSCORE II, % 6.92 ± 2.23 6.67 ± 2.01 0.57 LVEF > 50% 119 (76.77) 93(75.61) 0.82 41%-50% 14 (9.03) 11 (8.94) 0.84 30%-40% 21 (13.55) 19 (15.44) 0.65 <30% 1 (0.65) 0 0.37 NYHA functional class ≥ III 128 (82.58) 104 (84.55) 0.66 Values are n/N (%), or mean ± SD (N). PCI: percutaneous coronary intervention; CABG: Coronary Artery Bypass Grafting; EuroSCORE: European System for Cardiac Operative Risk Evaluation; LVEF: left ventricular ejection fraction;NYHA: New York Heart Association; 3.2 Procedural details and in-hospital outcomes The technical success was achieved in the AS group and the AR group were 98.06% (152/155) and 97.56% (120/123), respectively. Implanted valve size was comparable between the two groups (p < 0.05). There were no significant differences in procedural complications, including PVL (moderate or greater), valve migration, valve thrombosis, new permanent pacemaker implantation, acute kidney injury (p < 0.05). However, it is worth noting that the incidence of these parameters was higher in the AR group than in the AS group. The hospital stays (12.45 ± 6.59 days in AS vs 11.66 ± 6.53 days in AR, P = 0.87). In addition, the ICU (9.58 ± 18.24 days in AS vs 9.15 ± 10.25 days in AR, P = 0.72) stays were not significantly different. Details of the intraoperative details and in-hospital outcomes are shown in Table 3 . Table 3 Procedural details and in-hospital outcomes. AS(n = 155) AR(n = 123) p value Successful implantation rate 98.06 (152/155) 97.56 (120/123) 0.77 Conversion to open SAVR 3 (1.94) 3 (2.44 ) 0.77 Value size, mm 21 0 1 (0.81) 0.26 23 38 (24.52) 28 (22.76) 0.73 24 3 (1.94) 3 (2.44) 0.77 26 41(26.45) 23 (18.70) 0.13 27 7 (4.52) 7 (5.69) 0.66 29 30 (19.35) 28 (22.76) 0.49 30 32 (20.65) 29 (23.58) 0.56 31 4 (2.58) 4 (3.25) 0.74 Valve type VitaFlow 112 (72.26) 84 (68.29) 0.47 Taurus One-Valve 43 (27.74) 39 (31.71) 0.47 Procedure duration, min 128.69 ± 67.52 130.12 ± 51.58 0.67 Second valve needed 11 (7.10) 10 (8.13) 0.75 New permanent pacemaker implantation 1 (0.65) 2 (1.62) 0.43 PVL (moderate or greater) 2 (1.29) 2 (1.63) 0.82 Valve migration 3 (1.94) 4 (3.25) 0.49 Annular rupture 0 0 >0.99 Coronary obstruction 0 0 >0.99 Valve thrombosis 3 (1.29) 2 (1.62) 0.85 New cerebrovascular events 0 0 >0.99 Acute kidney injury 8 (5.16) 9 (7.32) 0.46 ICU stay, h 9.58 ± 18.24 9.15 ± 10.25 0.72 Total hospital stay, d 12.45 ± 6.59 11.66 ± 6.53 0.87 LVEF > 50% 127 (81.93) 89 (72.36) 0.06 41%-50% 19 (12.26) 20 (16.26) 0.34 30%-40% 9 (5.81) 14 (11.38) 0.09 0.99 NYHA functional class < III 129 (83.23) 98 (79.67) 0.45 Values are n/N (%), or mean ± SD (N). SAVR: Surgical aortic valve replacement; ICU: Intensive Care Unit; LVEF: left ventricular ejection fraction;NYHA: New York Heart Association; PVL: perivalvular leakage 3.3 Safety evaluation endpoints at 1 year after discharge The 1-year all-cause mortality rate in the AS group and the AR group was 1.94% and 3.25%, respectively. There were no significant differences in 1 year outcomes after TAVR, including cardiovascular mortality, new permanent pacemaker implantation, valve-related reintervention, PVL (moderate or greater), and all-cause mortality rates between the 2 groups. However, it is worth noting that the incidence of these parameters was higher in the AR group than in the AS group (Table 4 ). Table 4 Endpoint of 1-year safety evaluation after discharge AS(n = 155) AR(n = 123) p value All-cause mortality 3 (1.94) 4 (3.25) 0.49 Cardiovascular mortality 1 (0.65) 2 (1.62) 0.43 New permanent pacemaker implantation 5 (3.23) 6 (4.88) 0.48 Valve-related reintervention 2 (1.29) 2 (1.63) 0.82 PVL (moderate or greater) 3 (1.94) 5 (4.07) 0.29 New Myocardial infarction 0 0 > 0.99 New cerebrovascular accident 0 0 > 0.99 Severe bleeding 0 0 > 0.99 Composite MAE rate 9 (5.81) 8 (6.50) 0.73 Values are n/N (%). MAE: major adverse events; PVL: perivalvular leakage 3.4 Evaluation of the efficacy at 1 year after discharge The proportion of patients in the cardiac function NYHA classifications ≤ II increased from 17.42–83.43% in the AS group form pre-TAVR to 1 year after discharge, and in the AR group it increased from 15.45–79.67%. In order to better assess the trend of the cardiac function NYHA classifications within 1 year after TAVR treatment, we conducted statistics at admission, at discharge, 6 and 12 months after discharge (Fig. 2 ). 3.5 Echocardiography assessments at 1 year after discharge In order to better compare the therapeutic effect of TAVR on AS and AR, as well as the recovery of cardiac function, we conducted a comparison of the LVEF and LV diameter in each group (Fig. 3 A-B). During the 1-year follow up, the LVEF in the AS group increased from 56.24 ± 10.98% at admission to 58.06 ± 8.69% ( P = 0.48). In the AR group, the LVEF increased from 50.90 ± 8.88% at admission to 56.49 ± 8.87% ( P < 0.01). In addition, the LV diameter in the AR group significantly decreased from 59.89 ± 8.49 at admission to 52.89 ± 7.35 ( P < 0.01), while the LV diameter in the AS group also decreased from 51.47 ± 8.12 at admission to 49.68 ± 6.33 ( P = 0.25). The interventricular septal thickness (IVST) and the left ventricular posterior wall thickness (LVPWT) are also of great significance in assessing the health status of the heart[ 13 , 14 ]. This study found that in the AS group, the IVST and LVPWT decreased from 13.41 ± 1.94 and 11.84 ± 2.19 to 12.09 ± 1.80 and 10.96 ± 1.79, respectively, both with significant statistical significance ( P < 0.01 and P = 0.01). However, in the AR group, the changes in IVST and LVPWT were not significant ( P = 0.73 and P = 0.71), which may be related to the baseline of the two groups (Fig. 3 C-D). Table 5 details the echocardiographic results of the 1-year follow-up. Table 5 Echocardiogram results at 1-year follow-up AS(n = 57) AR(n = 85) LVEF (%) At admission 56.24 ± 10.98 50.90 ± 8.88 Before discharge 59.14 ± 9.07 53.23 ± 9.82 6 Months 59.56 ± 9.95 55.04 ± 10.20 12 Months 58.06 ± 8.69 56.49 ± 8.87 LV (mm) At admission 51.47 ± 8.12 59.89 ± 8.49 Before discharge 51.08 ± 7.08 56.58 ± 8.84 6 Months 50.58 ± 7.64 53.54 ± 7.35 12 Months 49.68 ± 6.33 52.89 ± 7.35 IVST (mm) At admission 13.41 ± 1.94 11.36 ± 2.07 Before discharge 12.85 ± 1.82 11.40 ± 2.24 6 Months 12.39 ± 1.75 11.64 ± 2.19 12 Months 12.09 ± 1.80 11.51 ± 1.96 LVPWT (mm) At admission 11.84 ± 2.19 10.39 ± 1.66 Before discharge 11.35 ± 1.95 10.42 ± 1.81 6 Months 11.12 ± 1.84 10.48 ± 1.55 12 Months 10.96 ± 1.79 10.46 ± 1.78 Values are mean ± SD. LVEF: Left Ventricular Ejection Fraction (LVEF); LV: Left Ventricular Diameter; IVST: Interventricular Septal Thickness; LVPWT: Left Ventricular Posterior Wall Thickness. 4. Discussion Although TAVR is indicated for aortic stenosis of varying severity, some patients undergo TAVR for other indications, such as bicuspid aortic valve disease, surgically failed bioprosthetic valves, and aortic regurgitation (AR) [ 15 – 17 ]. The efficacy of TAVR for these indications has not been fully established. This study performed a retrospective analysis of patients who underwent transfermoral TAVR for AR and AS between July 2020 and June 2024. It was found that in “off-label” TAVR device (Pself-expanding valves, including VitaFlow (Microport) and Taurus One-Valve (Peijia Medical)), the AS group (98.06%) and the AR group (97.56%) had a similar valve implantation success rates were similar and not significantly different (P = 0.87). There was also no significant difference in the rate of complications during hospitalization, the 1-year all-cause mortality rate, the incidence of composite MAE, and the proportion of patients with NYHA cardiac function ≤ II were consistent between the two groups (P > 0.05). But most of these parameters were higher in the AR group than in the AS group (P > 0.05). These data suggest that transfemoral TAVR has a favorable short term safety and feasibility profile for the treatment of both AR and AS, but the results of this study need to be further confirmed with an expanded sample. The worse outcome of patients receiving TAVR for AR compared to AS was previously confirmed in the analysis of registry data analyzing “off-label” versus “on-label” TAVR [ 15 ]. In the present study, we found that the occurrence of adverse events was higher in the AR group than in the AS group in terms of perioperative outcomes and 1-year follow-up outcomes, but there was no significant difference between the two groups, which may be attributed to the limitations of the sample size.Another retrospective study analyzed 254 high surgical risk patients undergoing TAVR for AR and found improved device success, and complication rates, compared to older generation devices [ 18 ]. However, in this study we only analyzed whether there was a difference between the two groups in terms of the type of device used, and did not go on to explicitly analyze the differences in the treatment of AR and AS by different devices, which is something to think about. In addition, recent studies have invented that dedicated TAVR devices for native AR show superior device success rates and reduced mortality, residual AR, and reintervention rates compared to “off-label” devices [ 19 ]. These suggest the need for dedicated devices for TAVR in AR. Compared to previous studies, this research made unique observations regarding cardiac function improvement. While past studies focused on surgical success rates and mortality, this study emphasized specific changes in cardiac function after TAVR among different disease types. In the AR group, significant improvements were seen in LVEF and LV indices (P 0.05). The AS group showed different statistical patterns in echocardiographic results. However, it is worth noting that baseline LV was greater in the AR group than in the AS group; whereas LVEF was lower than in the AS group. This is consistent with the pathophysiologic features of previous AR occurrences [ 20 , 21 ]. We therefore hypothesized that the significant improvement in LVEF and LV indices in AR patients post-TAVR can be attributed to the pathophysiological characteristics of AR. Volume overload from AR leads to left ventricular dilation and functional decline, and TAVR effectively reduces regurgitation, alleviating this overload and improving cardiac function [ 22 ]. This is different from AS, in which most symptomatic patients retain left ventricular systolic function [ 23 ]. The main changes in AS patients were in IVST and LVPWT, which may be due to the greater thickness of the LV wall before surgery. The large preoperative baseline difference between the two groups may be attributed to its different pathophysiologic mechanisms from AR. These differences highlight the need for personalized treatment plans based on specific patient pathophysiology. 5. Study Limitations This study has several limitations: (1) the modest sample size and one-year follow-up period. Future investigations with larger cohorts and longer-term follow-up are needed. (2) The study was conducted in a single medical center, which may limit the generalizability of the findings to a broader population. (3) The study design was retrospective, meaning it is susceptible to issues related to data accuracy, missing data, and potential biases in data collection. 6. Study Conclusions This single-center study demonstrated the short-term safety and feasibility of the “off-label” TAVR device in patients with AR, but a larger sample size is needed for validation. In addition, it showed different degrees of improvement in LV structural and functional parameters in the two groups, which may be attributed to both pathophysiologic features. Abbreviations AR: Aortic regurgitation; AS: Aortic stenosis; TAVR: Transcatheter aortic valve replacement; MAE: Major adverse events; NYHA: New York Heart Association; TTE: Transthoracic echocardiography; ASE: American Society of Echocardiography; PCI: Percutaneous coronary intervention; CABG: Coronary Artery Bypass Grafting; EuroSCORE: European System for Cardiac Operative Risk Evaluation; LVEF: Left ventricular ejection fraction； NYHA: New York Heart Association; SAVR: Surgical aortic valve replacement; ICU：Intensive Care Unit; PVL: perivalvular leakage LV: Left Ventricular Diameter; IVST: Interventricular Septal Thickness; LVPWT: Left Ventricular Posterior Wall Thickness; Declarations Ethics approval and consent to participate This study was approved by the Institutional Review Board of Southwest Hospital of Army Medical University (KY2024319). The informed consent was signed by all patients to allow the intervention and data recording. All procedures performed in this study involving human participants were in accordance with the Declaration of Helsinki (as revised in 2013). Given the retrospective nature of this study, the waiver of informed consent by the Institutional Review Board aligns with the customary practices for such research endeavors. Consent for publication not applicable Availability of data and material The datasets used in this study are available from the corresponding author upon reasonable request. Conflicts of Interest The authors have no conflicts of interest to declare. Funding This work was supported by the National Natural Science Foundation of China (No.82370483), the Chongqing Science and Chongqing Natural Science Foundation Project (No. CSTB2023NSCQ-ZDX0014 and CSTB2023NSCQ-MSX0672). Author contributions WC were responsible for the study concept and design. XQT, SJY, CJY, RHX, XX, HJZ, MG, JL, PH and WC were responsible for the acquisition and analysis of data. 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Vincent F, Ternacle J, Denimal T, Shen M, Redfors B, Delhaye C, Simonato M, Debry N, Verdier B, Shahim B et al : Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Stenosis . Circulation 2021, 143 (10):1043-1061. Sawaya FJ, Deutsch MA, Seiffert M, Yoon SH, Codner P, Wickramarachchi U, Latib A, Petronio AS, Rodés-Cabau J, Taramasso M et al : Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study . JACC Cardiovasc Interv 2017, 10 (10):1048-1056. De Backer O, Pilgrim T, Simonato M, Mackensen GB, Fiorina C, Veulemanns V, Cerillo A, Schofer J, Amabile N, Achkouty G et al : Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation . Am J Cardiol 2018, 122 (6):1028-1035. Samimi S, Hatab T, Kharsa C, Khan SU, Bou Chaaya RG, Qamar F, Aoun J, Zaid S, Faza N, Atkins MD et al : Meta-Analysis of Dedicated vs Off-Label Transcatheter Devices for Native Aortic Regurgitation . JACC Cardiovasc Interv 2025, 18 (1):44-57. Ross J, Jr.: Afterload mismatch in aortic and mitral valve disease: implications for surgical therapy . J Am Coll Cardiol 1985, 5 (4):811-826. Flint N, Wunderlich NC, Shmueli H, Ben-Zekry S, Siegel RJ, Beigel R: Aortic Regurgitation . Curr Cardiol Rep 2019, 21 (7):65. Bonow RO, Dodd JT, Maron BJ, O'Gara PT, White GG, McIntosh CL, Clark RE, Epstein SE: Long-term serial changes in left ventricular function and reversal of ventricular dilatation after valve replacement for chronic aortic regurgitation . Circulation 1988, 78 (5 Pt 1):1108-1120. Bonow RO, Leon MB, Doshi D, Moat N: Management strategies and future challenges for aortic valve disease . Lancet 2016, 387 (10025):1312-1323. Additional Declarations No competing interests reported. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7001587","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":482985574,"identity":"d3f8ed1b-f31c-4c99-b455-02a38c82881f","order_by":0,"name":"Xiaoqin Tang","email":"","orcid":"","institution":"Southwest Hospital, Army Medical University","correspondingAuthor":false,"prefix":"","firstName":"Xiaoqin","middleName":"","lastName":"Tang","suffix":""},{"id":482985575,"identity":"6d3ae026-7071-4630-a25d-9400399b4abc","order_by":1,"name":"Sanjiu Yu","email":"","orcid":"","institution":"Southwest Hospital, Army Medical University","correspondingAuthor":false,"prefix":"","firstName":"Sanjiu","middleName":"","lastName":"Yu","suffix":""},{"id":482985576,"identity":"b1cf74c1-d13a-4e58-bd10-406558c86aae","order_by":2,"name":"Chaojun Yan","email":"","orcid":"","institution":"Southwest Hospital, Army Medical University","correspondingAuthor":false,"prefix":"","firstName":"Chaojun","middleName":"","lastName":"Yan","suffix":""},{"id":482985577,"identity":"4e570672-dccd-4492-a7f9-e640c5d774aa","order_by":3,"name":"Ruihan Xiao","email":"","orcid":"","institution":"Southwest Hospital, Army Medical University","correspondingAuthor":false,"prefix":"","firstName":"Ruihan","middleName":"","lastName":"Xiao","suffix":""},{"id":482985578,"identity":"de57cdc3-68db-4831-9a87-e02024f6ae96","order_by":4,"name":"Xin Xie","email":"","orcid":"","institution":"Southwest Hospital, Army Medical University","correspondingAuthor":false,"prefix":"","firstName":"Xin","middleName":"","lastName":"Xie","suffix":""},{"id":482985579,"identity":"d7b7c642-762b-421e-9339-28c56b2a3f68","order_by":5,"name":"Huajie Zheng","email":"","orcid":"","institution":"Southwest Hospital, Army Medical University","correspondingAuthor":false,"prefix":"","firstName":"Huajie","middleName":"","lastName":"Zheng","suffix":""},{"id":482985580,"identity":"77bcefb3-437c-4e19-a808-daf5c69e4002","order_by":6,"name":"Mei Guo","email":"","orcid":"","institution":"Southwest Hospital, Army Medical University","correspondingAuthor":false,"prefix":"","firstName":"Mei","middleName":"","lastName":"Guo","suffix":""},{"id":482985581,"identity":"c031beba-3ec5-456b-8be5-08c811e63ec3","order_by":7,"name":"Jun Li","email":"","orcid":"","institution":"Southwest Hospital, Army Medical University","correspondingAuthor":false,"prefix":"","firstName":"Jun","middleName":"","lastName":"Li","suffix":""},{"id":482985582,"identity":"db84a68b-abb5-4712-a330-4da6d85ba48d","order_by":8,"name":"Ping He","email":"","orcid":"","institution":"Southwest Hospital, Army Medical University","correspondingAuthor":false,"prefix":"","firstName":"Ping","middleName":"","lastName":"He","suffix":""},{"id":482985583,"identity":"c6244c9a-6f9e-4361-8d32-8afb2d1a02ab","order_by":9,"name":"Wei Cheng","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAoUlEQVRIiWNgGAWjYFCCA2wMDBUScvwkajljYSzZQIIeNgbGtorEDURrMTh4+Nlj3nkSjBsYmB8+ukGUlgPHzI15t0kwmzOwGRvnEKflDJt07jYJNssGHjZpErTMkeAxOECalgYJCeK1SB44Zib955iEgWQzsX7hu3H4meSMmrr6fvbmh4+J0qJw4wCUxUyMchCQ728gVukoGAWjYBSMWAAAGn4wKwvyYDEAAAAASUVORK5CYII=","orcid":"","institution":"Southwest Hospital, Army Medical University","correspondingAuthor":true,"prefix":"","firstName":"Wei","middleName":"","lastName":"Cheng","suffix":""}],"badges":[],"createdAt":"2025-06-29 08:38:16","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7001587/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7001587/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":86664691,"identity":"b839259c-356e-413d-bb5f-4f19da30b6ea","added_by":"auto","created_at":"2025-07-14 10:55:33","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":1062680,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFlow diagram of inclusion process.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"fig1.png","url":"https://assets-eu.researchsquare.com/files/rs-7001587/v1/1d23562ec94a6de0d265814c.png"},{"id":86665519,"identity":"bb62b219-0c76-4f64-8d89-f8c9126f002b","added_by":"auto","created_at":"2025-07-14 11:03:33","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":2056470,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eChanges in the cardiac function NYHA classifications at admission, at discharge, 6 and 12 months after discharge in each group\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"fig2.png","url":"https://assets-eu.researchsquare.com/files/rs-7001587/v1/93dec780678d585e3cec5d06.png"},{"id":86665520,"identity":"3cf122f4-d289-4370-9ad0-72fdb0baa414","added_by":"auto","created_at":"2025-07-14 11:03:33","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":1882551,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eChanges in echocardiographic parameters at admission, at discharge, 6 and 12 months after discharge in each group. \u003c/strong\u003eA. Changes in LVEF; B. Changes in LV; C. Changes in IVST; D. Changes in LVPWT; LVEF: Left Ventricular Ejection Fraction; LV: Left Ventricular Diameter; IVST: Interventricular Septal Thickness; LVPWT: Left Ventricular Posterior Wall Thickness.\u003c/p\u003e","description":"","filename":"fig3.png","url":"https://assets-eu.researchsquare.com/files/rs-7001587/v1/30379d7efa9abdf741cd7d9e.png"},{"id":89303153,"identity":"dd848b44-695d-4fb6-8822-6b1c06de247d","added_by":"auto","created_at":"2025-08-18 14:47:41","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":8198122,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7001587/v1/700bb190-c684-4bdd-84b1-8133f9ddf18d.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"One-Year Outcomes of “off-label” Transcatheter Devices in Native Aortic Regurgitations","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003eValvular heart disease is a leading cause of disability, deteriorating quality of life, and cardiovascular morbidity and mortality worldwide [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. In developed countries, aortic valve disease accounts for 61% of all valvular heart disease deaths, while mitral valve disease accounts for 15% [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Over the past two decades, Transcatheter aortic valve replacement (TAVR) has changed the treatment paradigm for symptomatic severe AS, representing a minimally invasive alternative to surgery [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Recently, two landmarks randomized controlled trials, PARTNER 3 and EVOLUT Low Risk have confirmed that TAVR has better outcomes compared to SAVR, even in patients with symptomatic AS and lower surgical risk [\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Consequently, TAVR has revolutionized the treatment of aortic stenosis (AS) and is now approved for patients of all risk profiles with severe symptomatic AS [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAlthough TAVR is indicated for native severe AS, it has also been performed in select patients for other indications, such as bicuspid aortic valve disease, failed surgical bioprosthetic valve, and aortic regurgitation (AR). There are few TAVR valves specially designed to treat AR. In mainland China, there is a lack of \u0026ldquo;on-label\u0026rdquo; transfemoral aortic valves for AR. Previous studies have reported the feasibility and outcomes of the \u0026ldquo;off-label\u0026rdquo; use of transfemoral transcatheter aortic valves for the treatment of patients with purely autologous AR (PNAR) [\u003cspan additionalcitationids=\"CR8\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. There was no head-to-head study to compare their performance in TAVR for AS or AR. Therefore, this retrospective study aims to evaluate the safety and feasibility of an \u0026ldquo;off-label\u0026rdquo; TAVR device in patients with AR, compared to control group of patients treated with TAVR for AS. Therefore, this retrospective study aims to assess the safety and feasibility of off-label TAVR devices in pure native AR patients with a control group of patients treated with TAVR for AS.\u003c/p\u003e"},{"header":"2. Patients and Methods","content":"\u003cdiv id=\"Sec3\"\u003e\n \u003ch2\u003e2.1 Study design\u003c/h2\u003e\n \u003cp\u003eThis study is a retrospective analysis of the clinical outcomes of TAVR in patients with AS and AR. Data was collected from all consecutive patients who underwent TAVR at our center from January 2020 and June 2024. A detailed list of specific inclusion criteria and exclusion criteria is shown in Table\u0026nbsp;1. Upon admission, each patient underwent a comprehensive clinical examination, laboratory tests, and transthoracic echocardiography (TTE). TTE was also used routinely during each TAVR. Definitions and terminology were harmonized with those employed in the STS/ACC Transcatheter Valve Therapy Registry.\u003c/p\u003e\n \u003cp\u003eComprehensive clinical and echocardiographic assessments were performed for all included patients before the procedure, upon discharge, and at 6 and 12 months post-discharge. All patients were followed up postoperatively through telephone calls or direct interviews, and all completed the 1-year follow-up. This study was conducted in accordance with the principles of good clinical practice and the Helsinki Declaration, and was approved by the Ethics Committee of Southwest Hospital (KY2024319).\u003c/p\u003e\n \u003cdiv\u003e\n \u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"574\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003eTable 1. Inclusion Criteria and Exclusion Criteria.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eAS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eInclusion Criteria:\u003c/strong\u003e\u003c/p\u003e\n \u003col\u003e\n \u003cli\u003eAdult subjects with severe or moderate-to-severe AS as defined by the multiparametric approach of the American Society of Echocardiography (ASE) [10];\u003c/li\u003e\n \u003cli\u003eSymptomatic patients (Age ≥ 65 years) with clinical symptoms such as chest tightness, shortness of breath, chest pain, and dizziness caused by valvular disease; Or symptomatic patients (Age ≥ 80 years) with severe AS \u0026nbsp;or for younger patientswith a life expectancy \u0026lt; 10 years; Or asymptomatic patients (Age ≤ 80 years) with severe AS and an LVEF \u0026lt; 50%; Or patients have contraindications for surgical intervention or are at high risk, or have other risk factors such as previous chest radiotherapy, liver failure, diffuse severe aortic calcification, or extreme frailty [11];\u003c/li\u003e\n \u003cli\u003eNew York Heart Association (NYHA) functional class ≥ II and expected postoperative survival \u0026gt; 1 year.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eSuitable anatomy to accommodate the insertion and delivery of the Heart Valve System.\u003c/li\u003e\n \u003cli\u003eUse of the transfemoral approach.\u003c/li\u003e\n \u003c/ol\u003e\n \u003cp\u003e\u003cstrong\u003eExclusion Criteria:\u003c/strong\u003e\u003c/p\u003e\n \u003col\u003e\n \u003cli\u003ePresence of a concomitant AR.\u003c/li\u003e\n \u003cli\u003ePatients with degeneration of surgical bioprosthetic valves.\u003c/li\u003e\n \u003cli\u003ePatients with severe comorbidities, such as acute aortic dissection, infection, severe coagulopathy, and multi-organ failure.\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eAR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eInclusion Criteria:\u003c/strong\u003e\u003c/p\u003e\n \u003col\u003e\n \u003cli\u003eAdult subjects with moderate-to-severe or severe AR as defined by the multiparametric approach of the American Society of Echocardiography (ASE) [10].\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eSymptomatic patients (Age ≥ 65 years) who are contraindicated for or at high risk of surgical intervention, and are expected to achieve clinical benefit from the treatment. Or asymptomatic patients (Age ≥ 65 years) with contraindications or high risk of surgical intervention, and expected to achieve clinical benefits from treatment, must meet at least one of the following criteria: left ventricular end-diastolic dimension (LVEDD) \u0026gt;70 mm, left ventricular end-systolic dimension (LVESD) \u0026gt;50 mm, left ventricular end-systolic dimension index \u0026gt;25 mm/m², LVEF ≤55% [11].\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eNYHA functional class ≥ II and expected postoperative survival \u0026gt; 1 year.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eSuitable anatomy to accommodate the insertion and delivery of the Heart Valve System.\u003c/li\u003e\n \u003cli\u003eUse of the transfemoral approach.\u003c/li\u003e\n \u003c/ol\u003e\n \u003cp\u003e\u003cstrong\u003eExclusion Criteria:\u003c/strong\u003e\u003c/p\u003e\n \u003col\u003e\n \u003cli\u003eThe presence of a concomitant moderate to severe AS.\u003c/li\u003e\n \u003cli\u003ePatients with degeneration of surgical bioprosthetic valves;\u003c/li\u003e\n \u003cli\u003ePatients with severe comorbidities, such as acute aortic dissection, infection, severe coagulopathy, and multi-organ failure\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec4\"\u003e\n \u003ch2\u003e2.2 TAVR procedure\u003c/h2\u003e\n \u003cp\u003eThe multidisciplinary heart team, comprising an interventional cardiologist, cardiovascular surgeon, echocardiographer, and anesthesiologist, decided to perform TAVR. Procedures have been previously described [12]. Patients received self-expanding valves, including VitaFlow (Microport) and Taurus One-Valve (Peijia Medical). Valve sizing relied on MDCT. Transfemoral access was preferred in all patients. Post-TAVR, dual antiplatelet therapy (aspirin 100 mg and clopidogrel 75 mg) was administered in nearly all cases. Where indicated, warfarin or novel oral anticoagulants were used.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec5\"\u003e\n \u003ch2\u003e2.3 Study endpoints\u003c/h2\u003e\n \u003cp\u003eThe primary safety study endpoint was the all-cause mortality rate at 1 year post-discharge, as well as the composite rate of MAE including valve displacement, cardiovascular events, and stroke. The secondary efficacy study endpoint was the proportion of patients with a the cardiac function NYHA classifications II or better (NYHA classifications ≤ II), as assessed by clinicians combining echocardiographic results and clinical manifestations at 1-year post-discharge. Other study endpoints included echocardiographic assessments at admission, before discharge, and at 6 and 12 months post-discharge. Data were collected from our institutional database, consisting primarily of preoperative and perioperative information and postoperative outcomes. Regarding postoperative follow-up, data were gathered via examination of medical records or by engaging in telephone conversations with patients.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec6\"\u003e\n \u003ch2\u003e2.4 Statistical analysis\u003c/h2\u003e\n \u003cp\u003eStatistical analysis is performed using statistical software (SPSS version 23.0, IBM, New York, NY). For normally distributed data, continuous variables are expressed as mean ± standard deviation (SD). Categorical data are reported as frequencies and percentages. The Shapiro-Wilk test is used to test for normality of continuous variables, while the non-parametric Mann-Whitney U test is used to analyze continuous variables that are not normally distributed. Chi-square or Fisher's exact test is used to compare categorical variables between groups. \u003cem\u003eP\u003c/em\u003e \u0026lt; 0.05 is considered statistically significant.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"3. Results","content":"\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003e3.1 Baseline characteristics\u003c/h2\u003e\u003cp\u003eBetween January 2020 and June 2024, 445 consecutive patients received transfemoral TAVR treatment for aortic valve disease at our department, of which 177 were excluded due to patients with AS and concomitant AR (moderate or greater), etc., as shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Of the remaining 278 patients, 155 had AS (age: 71.12\u0026thinsp;\u0026plusmn;\u0026thinsp;4.84, 45.76% female), and 123 had AR (age: 70.14\u0026thinsp;\u0026plusmn;\u0026thinsp;5.12, 42.27% female). There was no significant difference between the two groups in terms of age, race, diabetes, hypertension, chronic lung diseases, peripheral vascular disease, and coronary artery disease history. Simultaneously, 80% of the patients had the cardiac function NYHA classifications\u0026thinsp;\u0026ge;\u0026thinsp;III in both groups. A detailed description of the specific characteristics of the patients is listed in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eBaseline Clinical Characteristics\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eAS(n\u0026thinsp;=\u0026thinsp;155)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eAR(n\u0026thinsp;=\u0026thinsp;123)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge, y\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e71.12\u0026thinsp;\u0026plusmn;\u0026thinsp;4.84\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e70.14\u0026thinsp;\u0026plusmn;\u0026thinsp;5.12\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.24\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSex (female)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e81 (45.76)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e52 (42.27)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.10\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBody mass index, kg/m2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e23.15\u0026thinsp;\u0026plusmn;\u0026thinsp;3.12\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e24.01\u0026thinsp;\u0026plusmn;\u0026thinsp;2.85\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.33\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDiabetes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e18 (11.61)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e8 (6.50)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.15\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHypertension\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e52 (33.55)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e51 (41.46)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.17\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eChronic pulmonary disease\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e14 (9.03)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e14 (11.38)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.65\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eChronic renal dysfunction\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e23 (14.84)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e22 (17.89)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.66\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePrior cerebrovascular accident\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (1.29)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4 (3.25)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.26\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAtrial fibrillation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e13 (8.39)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e11 (8.94)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.87\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCoronary artery disease\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e79 (50.97)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e60 (48.78)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.72\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePrior myocardial infarction\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2 (1.63)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.11\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePeripheral\u0026nbsp;arterial\u0026nbsp;disease\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e58 (37.42)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e44 (35.77)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.78\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAnemia\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e29 (18.71)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e17 (13.82)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.28\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePrior\u0026nbsp;PCI\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2 (1.63)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.11\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePrior CABG\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026gt;0.99\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePrior mitral valve surgery\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (1.29)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1 (0.81)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.70\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePrior permanent pacemaker implantation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (1.29)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.21\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLogistic EuroSCORE II, %\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6.92\u0026thinsp;\u0026plusmn;\u0026thinsp;2.23\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e6.67\u0026thinsp;\u0026plusmn;\u0026thinsp;2.01\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.57\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLVEF\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026gt;\u0026thinsp;50%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e119 (76.77)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e93(75.61)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.82\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e41%-50%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e14 (9.03)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e11 (8.94)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.84\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e30%-40%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e21 (13.55)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e19 (15.44)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.65\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026lt;30%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (0.65)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.37\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNYHA\u0026nbsp;functional\u0026nbsp;class\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026ge; III\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e128 (82.58)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e104 (84.55)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.66\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e\u003cp\u003eValues are n/N (%), or mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD (N). PCI: percutaneous coronary intervention; CABG: Coronary Artery Bypass Grafting; EuroSCORE: European System for Cardiac Operative Risk Evaluation; LVEF: left ventricular ejection fraction;NYHA: New York Heart Association;\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\u003ch2\u003e3.2 Procedural details and in-hospital outcomes\u003c/h2\u003e\u003cp\u003eThe technical success was achieved in the AS group and the AR group were 98.06% (152/155) and 97.56% (120/123), respectively. Implanted valve size was comparable between the two groups (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05). There were no significant differences in procedural complications, including PVL (moderate or greater), valve migration, valve thrombosis, new permanent pacemaker implantation, acute kidney injury (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05). However, it is worth noting that the incidence of these parameters was higher in the AR group than in the AS group. The hospital stays (12.45\u0026thinsp;\u0026plusmn;\u0026thinsp;6.59 days in AS \u003cem\u003evs\u003c/em\u003e 11.66\u0026thinsp;\u0026plusmn;\u0026thinsp;6.53 days in AR, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.87). In addition, the ICU (9.58\u0026thinsp;\u0026plusmn;\u0026thinsp;18.24 days in AS \u003cem\u003evs\u003c/em\u003e 9.15\u0026thinsp;\u0026plusmn;\u0026thinsp;10.25 days in AR, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.72) stays were not significantly different. Details of the intraoperative details and in-hospital outcomes are shown in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eProcedural details and in-hospital outcomes.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eAS(n\u0026thinsp;=\u0026thinsp;155)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eAR(n\u0026thinsp;=\u0026thinsp;123)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSuccessful implantation rate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e98.06 (152/155)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e97.56 (120/123)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.77\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eConversion to open SAVR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (1.94)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3 (2.44 )\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.77\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eValue\u0026nbsp;size,\u0026nbsp;mm\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e21\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1 (0.81)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.26\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e23\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e38 (24.52)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e28 (22.76)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.73\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e24\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (1.94)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3 (2.44)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.77\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e26\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e41(26.45)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e23 (18.70)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.13\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e7 (4.52)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e7 (5.69)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.66\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e29\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e30 (19.35)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e28 (22.76)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.49\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e30\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e32 (20.65)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e29 (23.58)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.56\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e31\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4 (2.58)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4 (3.25)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.74\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eValve type\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVitaFlow\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e112 (72.26)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e84 (68.29)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.47\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTaurus One-Valve\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e43 (27.74)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e39 (31.71)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.47\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eProcedure duration, min\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e128.69\u0026thinsp;\u0026plusmn;\u0026thinsp;67.52\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e130.12\u0026thinsp;\u0026plusmn;\u0026thinsp;51.58\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.67\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSecond valve needed\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e11 (7.10)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10 (8.13)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.75\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNew permanent pacemaker implantation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (0.65)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2 (1.62)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.43\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePVL (moderate or greater)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (1.29)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2 (1.63)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.82\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eValve migration\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (1.94)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4 (3.25)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.49\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAnnular\u0026nbsp;rupture\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026gt;0.99\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCoronary obstruction\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026gt;0.99\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eValve\u0026nbsp;thrombosis\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (1.29)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2 (1.62)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.85\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNew cerebrovascular events\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026gt;0.99\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAcute kidney injury\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e8 (5.16)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e9 (7.32)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.46\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eICU\u0026nbsp;stay,\u0026nbsp;h\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e9.58\u0026thinsp;\u0026plusmn;\u0026thinsp;18.24\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e9.15\u0026thinsp;\u0026plusmn;\u0026thinsp;10.25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.72\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTotal hospital stay, d\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e12.45\u0026thinsp;\u0026plusmn;\u0026thinsp;6.59\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e11.66\u0026thinsp;\u0026plusmn;\u0026thinsp;6.53\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.87\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLVEF\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026gt;\u0026thinsp;50%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e127 (81.93)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e89 (72.36)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.06\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e41%-50%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e19 (12.26)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e20 (16.26)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.34\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e30%-40%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e9 (5.81)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e14 (11.38)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.09\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026lt;30%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026gt;0.99\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNYHA\u0026nbsp;functional\u0026nbsp;class\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026lt; III\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e129 (83.23)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e98 (79.67)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.45\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e\u003cp\u003eValues are n/N (%), or mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD (N). SAVR: Surgical aortic valve replacement; ICU: Intensive Care Unit; LVEF: left ventricular ejection fraction;NYHA: New York Heart Association; PVL: perivalvular leakage\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\u003ch2\u003e3.3 Safety evaluation endpoints at 1 year after discharge\u003c/h2\u003e\u003cp\u003eThe 1-year all-cause mortality rate in the AS group and the AR group was 1.94% and 3.25%, respectively. There were no significant differences in 1 year outcomes after TAVR, including cardiovascular mortality, new permanent pacemaker implantation, valve-related reintervention, PVL (moderate or greater), and all-cause mortality rates between the 2 groups. However, it is worth noting that the incidence of these parameters was higher in the AR group than in the AS group (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eEndpoint of 1-year safety evaluation after discharge\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eAS(n\u0026thinsp;=\u0026thinsp;155)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eAR(n\u0026thinsp;=\u0026thinsp;123)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAll-cause mortality\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (1.94)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4 (3.25)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.49\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCardiovascular mortality\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (0.65)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2 (1.62)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.43\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNew permanent pacemaker implantation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e5 (3.23)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e6 (4.88)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.48\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eValve-related reintervention\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (1.29)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2 (1.63)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.82\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePVL (moderate or greater)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (1.94)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5 (4.07)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.29\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNew Myocardial infarction\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026gt;\u0026thinsp;0.99\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNew cerebrovascular accident\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026gt;\u0026thinsp;0.99\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSevere bleeding\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026gt;\u0026thinsp;0.99\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eComposite MAE rate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e9 (5.81)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e8 (6.50)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.73\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e\u003cp\u003eValues are n/N (%). MAE: major adverse events; PVL: perivalvular leakage\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003e3.4 Evaluation of the efficacy at 1 year after discharge\u003c/h2\u003e\u003cp\u003eThe proportion of patients in the cardiac function NYHA classifications\u0026thinsp;\u0026le;\u0026thinsp;II increased from 17.42\u0026ndash;83.43% in the AS group form pre-TAVR to 1 year after discharge, and in the AR group it increased from 15.45\u0026ndash;79.67%. In order to better assess the trend of the cardiac function NYHA classifications within 1 year after TAVR treatment, we conducted statistics at admission, at discharge, 6 and 12 months after discharge (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003e3.5 Echocardiography assessments at 1 year after discharge\u003c/h2\u003e\u003cp\u003eIn order to better compare the therapeutic effect of TAVR on AS and AR, as well as the recovery of cardiac function, we conducted a comparison of the LVEF and LV diameter in each group (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eA-B). During the 1-year follow up, the LVEF in the AS group increased from 56.24\u0026thinsp;\u0026plusmn;\u0026thinsp;10.98% at admission to 58.06\u0026thinsp;\u0026plusmn;\u0026thinsp;8.69% (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.48). In the AR group, the LVEF increased from 50.90\u0026thinsp;\u0026plusmn;\u0026thinsp;8.88% at admission to 56.49\u0026thinsp;\u0026plusmn;\u0026thinsp;8.87% (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.01). In addition, the LV diameter in the AR group significantly decreased from 59.89\u0026thinsp;\u0026plusmn;\u0026thinsp;8.49 at admission to 52.89\u0026thinsp;\u0026plusmn;\u0026thinsp;7.35 (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.01), while the LV diameter in the AS group also decreased from 51.47\u0026thinsp;\u0026plusmn;\u0026thinsp;8.12 at admission to 49.68\u0026thinsp;\u0026plusmn;\u0026thinsp;6.33 (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.25).\u003c/p\u003e\u003cp\u003eThe interventricular septal thickness (IVST) and the left ventricular posterior wall thickness (LVPWT) are also of great significance in assessing the health status of the heart[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. This study found that in the AS group, the IVST and LVPWT decreased from 13.41\u0026thinsp;\u0026plusmn;\u0026thinsp;1.94 and 11.84\u0026thinsp;\u0026plusmn;\u0026thinsp;2.19 to 12.09\u0026thinsp;\u0026plusmn;\u0026thinsp;1.80 and 10.96\u0026thinsp;\u0026plusmn;\u0026thinsp;1.79, respectively, both with significant statistical significance (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.01 and \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.01). However, in the AR group, the changes in IVST and LVPWT were not significant (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.73 and \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.71), which may be related to the baseline of the two groups (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eC-D). Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e details the echocardiographic results of the 1-year follow-up.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eEchocardiogram results at 1-year follow-up\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eAS(n\u0026thinsp;=\u0026thinsp;57)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eAR(n\u0026thinsp;=\u0026thinsp;85)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLVEF (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAt admission\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e56.24\u0026thinsp;\u0026plusmn;\u0026thinsp;10.98\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e50.90\u0026thinsp;\u0026plusmn;\u0026thinsp;8.88\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBefore discharge\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e59.14\u0026thinsp;\u0026plusmn;\u0026thinsp;9.07\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e53.23\u0026thinsp;\u0026plusmn;\u0026thinsp;9.82\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e6 Months\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e59.56\u0026thinsp;\u0026plusmn;\u0026thinsp;9.95\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e55.04\u0026thinsp;\u0026plusmn;\u0026thinsp;10.20\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e12 Months\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e58.06\u0026thinsp;\u0026plusmn;\u0026thinsp;8.69\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e56.49\u0026thinsp;\u0026plusmn;\u0026thinsp;8.87\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eLV (mm)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAt admission\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e51.47\u0026thinsp;\u0026plusmn;\u0026thinsp;8.12\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e59.89\u0026thinsp;\u0026plusmn;\u0026thinsp;8.49\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBefore discharge\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e51.08\u0026thinsp;\u0026plusmn;\u0026thinsp;7.08\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e56.58\u0026thinsp;\u0026plusmn;\u0026thinsp;8.84\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e6 Months\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e50.58\u0026thinsp;\u0026plusmn;\u0026thinsp;7.64\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e53.54\u0026thinsp;\u0026plusmn;\u0026thinsp;7.35\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e12 Months\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e49.68\u0026thinsp;\u0026plusmn;\u0026thinsp;6.33\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e52.89\u0026thinsp;\u0026plusmn;\u0026thinsp;7.35\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eIVST (mm)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAt admission\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e13.41\u0026thinsp;\u0026plusmn;\u0026thinsp;1.94\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e11.36\u0026thinsp;\u0026plusmn;\u0026thinsp;2.07\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBefore discharge\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e12.85\u0026thinsp;\u0026plusmn;\u0026thinsp;1.82\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e11.40\u0026thinsp;\u0026plusmn;\u0026thinsp;2.24\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e6 Months\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e12.39\u0026thinsp;\u0026plusmn;\u0026thinsp;1.75\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e11.64\u0026thinsp;\u0026plusmn;\u0026thinsp;2.19\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e12 Months\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e12.09\u0026thinsp;\u0026plusmn;\u0026thinsp;1.80\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e11.51\u0026thinsp;\u0026plusmn;\u0026thinsp;1.96\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eLVPWT (mm)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAt admission\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e11.84\u0026thinsp;\u0026plusmn;\u0026thinsp;2.19\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10.39\u0026thinsp;\u0026plusmn;\u0026thinsp;1.66\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBefore discharge\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e11.35\u0026thinsp;\u0026plusmn;\u0026thinsp;1.95\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10.42\u0026thinsp;\u0026plusmn;\u0026thinsp;1.81\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e6 Months\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e11.12\u0026thinsp;\u0026plusmn;\u0026thinsp;1.84\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10.48\u0026thinsp;\u0026plusmn;\u0026thinsp;1.55\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e12 Months\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e10.96\u0026thinsp;\u0026plusmn;\u0026thinsp;1.79\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10.46\u0026thinsp;\u0026plusmn;\u0026thinsp;1.78\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e\u003cp\u003eValues are mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD. LVEF: Left Ventricular Ejection Fraction (LVEF); LV: Left Ventricular Diameter; IVST: Interventricular Septal Thickness; LVPWT: Left Ventricular Posterior Wall Thickness.\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eAlthough TAVR is indicated for aortic stenosis of varying severity, some patients undergo TAVR for other indications, such as bicuspid aortic valve disease, surgically failed bioprosthetic valves, and aortic regurgitation (AR) [\u003cspan additionalcitationids=\"CR16\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. The efficacy of TAVR for these indications has not been fully established. This study performed a retrospective analysis of patients who underwent transfermoral TAVR for AR and AS between July 2020 and June 2024. It was found that in \u0026ldquo;off-label\u0026rdquo; TAVR device (Pself-expanding valves, including VitaFlow (Microport) and Taurus One-Valve (Peijia Medical)), the AS group (98.06%) and the AR group (97.56%) had a similar valve implantation success rates were similar and not significantly different (P\u0026thinsp;=\u0026thinsp;0.87). There was also no significant difference in the rate of complications during hospitalization, the 1-year all-cause mortality rate, the incidence of composite MAE, and the proportion of patients with NYHA cardiac function\u0026thinsp;\u0026le;\u0026thinsp;II were consistent between the two groups (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05). But most of these parameters were higher in the AR group than in the AS group (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05). These data suggest that transfemoral TAVR has a favorable short term safety and feasibility profile for the treatment of both AR and AS, but the results of this study need to be further confirmed with an expanded sample.\u003c/p\u003e\u003cp\u003eThe worse outcome of patients receiving TAVR for AR compared to AS was previously confirmed in the analysis of registry data analyzing \u0026ldquo;off-label\u0026rdquo; versus \u0026ldquo;on-label\u0026rdquo; TAVR [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. In the present study, we found that the occurrence of adverse events was higher in the AR group than in the AS group in terms of perioperative outcomes and 1-year follow-up outcomes, but there was no significant difference between the two groups, which may be attributed to the limitations of the sample size.Another retrospective study analyzed 254 high surgical risk patients undergoing TAVR for AR and found improved device success, and complication rates, compared to older generation devices [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. However, in this study we only analyzed whether there was a difference between the two groups in terms of the type of device used, and did not go on to explicitly analyze the differences in the treatment of AR and AS by different devices, which is something to think about. In addition, recent studies have invented that dedicated TAVR devices for native AR show superior device success rates and reduced mortality, residual AR, and reintervention rates compared to \u0026ldquo;off-label\u0026rdquo; devices [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. These suggest the need for dedicated devices for TAVR in AR.\u003c/p\u003e\u003cp\u003eCompared to previous studies, this research made unique observations regarding cardiac function improvement. While past studies focused on surgical success rates and mortality, this study emphasized specific changes in cardiac function after TAVR among different disease types. In the AR group, significant improvements were seen in LVEF and LV indices (P\u0026thinsp;\u0026lt;\u0026thinsp;0.01), with no significant changes in IVST or LVPWT (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05). The AS group showed different statistical patterns in echocardiographic results. However, it is worth noting that baseline LV was greater in the AR group than in the AS group; whereas LVEF was lower than in the AS group. This is consistent with the pathophysiologic features of previous AR occurrences [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. We therefore hypothesized that the significant improvement in LVEF and LV indices in AR patients post-TAVR can be attributed to the pathophysiological characteristics of AR. Volume overload from AR leads to left ventricular dilation and functional decline, and TAVR effectively reduces regurgitation, alleviating this overload and improving cardiac function [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. This is different from AS, in which most symptomatic patients retain left ventricular systolic function [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. The main changes in AS patients were in IVST and LVPWT, which may be due to the greater thickness of the LV wall before surgery. The large preoperative baseline difference between the two groups may be attributed to its different pathophysiologic mechanisms from AR. These differences highlight the need for personalized treatment plans based on specific patient pathophysiology.\u003c/p\u003e"},{"header":"5. Study Limitations","content":"\u003cp\u003eThis study has several limitations: (1) the modest sample size and one-year follow-up period. Future investigations with larger cohorts and longer-term follow-up are needed. (2) The study was conducted in a single medical center, which may limit the generalizability of the findings to a broader population. (3) The study design was retrospective, meaning it is susceptible to issues related to data accuracy, missing data, and potential biases in data collection.\u003c/p\u003e"},{"header":"6. Study Conclusions","content":"\u003cp\u003eThis single-center study demonstrated the short-term safety and feasibility of the \u0026ldquo;off-label\u0026rdquo; TAVR device in patients with AR, but a larger sample size is needed for validation. In addition, it showed different degrees of improvement in LV structural and functional parameters in the two groups, which may be attributed to both pathophysiologic features.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eAR: Aortic regurgitation;\u003c/p\u003e\n\u003cp\u003eAS: Aortic stenosis;\u003c/p\u003e\n\u003cp\u003eTAVR: Transcatheter aortic valve replacement;\u003c/p\u003e\n\u003cp\u003eMAE: Major adverse events;\u003c/p\u003e\n\u003cp\u003eNYHA: New York Heart Association;\u003c/p\u003e\n\u003cp\u003eTTE: Transthoracic echocardiography;\u003c/p\u003e\n\u003cp\u003eASE: American Society of Echocardiography;\u003c/p\u003e\n\u003cp\u003ePCI: Percutaneous coronary intervention;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCABG: Coronary Artery Bypass Grafting;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEuroSCORE: European System for Cardiac Operative Risk Evaluation;\u003c/p\u003e\n\u003cp\u003eLVEF: Left ventricular ejection fraction；\u003c/p\u003e\n\u003cp\u003eNYHA: New York Heart Association;\u003c/p\u003e\n\u003cp\u003eSAVR: Surgical aortic valve replacement;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eICU：Intensive Care Unit;\u003c/p\u003e\n\u003cp\u003ePVL: perivalvular leakage\u003c/p\u003e\n\u003cp\u003eLV: Left Ventricular Diameter;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIVST: Interventricular Septal Thickness;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eLVPWT: Left Ventricular Posterior Wall Thickness;\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was approved by the Institutional Review Board of Southwest Hospital of Army Medical University (KY2024319). The informed consent was signed by all patients to allow the intervention and data recording. All procedures performed in this study involving human participants were in accordance with the Declaration of Helsinki (as revised in 2013). Given the retrospective nature of this study, the waiver of informed consent by the Institutional Review Board aligns with the customary practices for such research endeavors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003enot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and material\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used in this study are available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflicts of Interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors have no conflicts of interest to declare.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis work was supported by the National Natural Science Foundation of China (No.82370483), the Chongqing Science and Chongqing Natural Science Foundation Project (No. CSTB2023NSCQ-ZDX0014 and CSTB2023NSCQ-MSX0672).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWC were responsible for the study concept and design. XQT, SJY, CJY, RHX, XX, HJZ, MG, JL, PH and WC were responsible for the acquisition and analysis of data. All authors contributed to the interpretation of the data. XQT, SJY, CJY drafted the manuscript. The corresponding author attests that all listed authors meet authorship criteria. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank the researchers and study participants for their contributions.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical trial number\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003enot applicable\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eVahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R\u003cem\u003e et al\u003c/em\u003e: \u003cstrong\u003e2021 ESC/EACTS Guidelines for the management of valvular heart disease\u003c/strong\u003e. \u003cem\u003eEur Heart J \u003c/em\u003e2022, \u003cstrong\u003e43\u003c/strong\u003e(7):561-632.\u003c/li\u003e\n\u003cli\u003eAluru JS, Barsouk A, Saginala K, Rawla P, Barsouk A: \u003cstrong\u003eValvular Heart Disease Epidemiology\u003c/strong\u003e. \u003cem\u003eMed Sci (Basel) \u003c/em\u003e2022, \u003cstrong\u003e10\u003c/strong\u003e(2).\u003c/li\u003e\n\u003cli\u003eCarroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, Deeb GM, Thourani VH, Cohen DJ, Desai N\u003cem\u003e et al\u003c/em\u003e: \u003cstrong\u003eSTS-ACC TVT Registry of Transcatheter Aortic Valve Replacement\u003c/strong\u003e. \u003cem\u003eJ Am Coll Cardiol \u003c/em\u003e2020, \u003cstrong\u003e76\u003c/strong\u003e(21):2492-2516.\u003c/li\u003e\n\u003cli\u003eRihal C: \u003cstrong\u003eOutcomes of TAVR in Minimally Symptomatic Aortic Stenosis\u003c/strong\u003e. \u003cem\u003eJACC Cardiovasc Interv \u003c/em\u003e2023, \u003cstrong\u003e16\u003c/strong\u003e(21):2642-2643.\u003c/li\u003e\n\u003cli\u003eMack MJ, Leon MB, Thourani VH, Pibarot P, Hahn RT, Genereux P, Kodali SK, Kapadia SR, Cohen DJ, Pocock SJ\u003cem\u003e et al\u003c/em\u003e: \u003cstrong\u003eTranscatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years\u003c/strong\u003e. \u003cem\u003eN Engl J Med \u003c/em\u003e2023, \u003cstrong\u003e389\u003c/strong\u003e(21):1949-1960.\u003c/li\u003e\n\u003cli\u003eMack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P\u003cem\u003e et al\u003c/em\u003e: \u003cstrong\u003eTranscatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients\u003c/strong\u003e. \u003cem\u003eN Engl J Med \u003c/em\u003e2019, \u003cstrong\u003e380\u003c/strong\u003e(18):1695-1705.\u003c/li\u003e\n\u003cli\u003eSchofer J, Nietlispach F, Bijuklic K, Colombo A, Gatto F, De Marco F, Mangieri A, Hansen L, Bruschi G, Ruparelia N\u003cem\u003e et al\u003c/em\u003e: \u003cstrong\u003eTransfemoral Implantation of a Fully Repositionable and Retrievable Transcatheter Valve for Noncalcified Pure Aortic Regurgitation\u003c/strong\u003e. \u003cem\u003eJACC Cardiovasc Interv \u003c/em\u003e2015, \u003cstrong\u003e8\u003c/strong\u003e(14):1842-1849.\u003c/li\u003e\n\u003cli\u003eChen S, Zheng F, Li M, Hou S, Zhang W, Zhang L, Zhang X, Pan W, Zhou D, Ge J: \u003cstrong\u003eA study on correlation between preprocedural CT indexes and procedural success rate of transfemoral transcatheter aortic valve replacement with different self-expanding valves (VitaFlow or VenusA-Valve) in patients with pure native aortic regurgitation\u003c/strong\u003e. \u003cem\u003eAnn Transl Med \u003c/em\u003e2022, \u003cstrong\u003e10\u003c/strong\u003e(11):643.\u003c/li\u003e\n\u003cli\u003eFrerker C, Schewel J, Schewel D, Wohlmuth P, Schmidt T, Kreidel F, Bader R, Kuck KH, Sch\u0026auml;fer U: \u003cstrong\u003eExpansion of the indication of transcatheter aortic valve implantation--feasibility and outcome in \u0026quot;off-label\u0026quot; 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transfemoral aortic valves for aortic regurgitation (AR). Consequently, this study sought to assess the safety and feasibility of \u0026ldquo;off-label\u0026rdquo; TAVR devices in AR patients.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eThis was a retrospective study utilizing our institutional TAVR database between January 2020 and June 2024. The study compared outcomes of \u0026ldquo;off-label\u0026rdquo; TAVR devices in patients with isolated aortic stenosis (AS) vs patients with pure native AR (moderate or greater). The outcome measure was 1-year all-cause mortality, the incidence of major adverse events (MAEs) and the New York Heart Association (NYHA) functional improvement.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eTotal 445 consecutive patients received transfemoral TAVR treatment for aortic valve disease at our department, of which 177 were excluded due to concomitant severe comorbidities and other special situations. No inter-group statistical differences were found in basic patient characteristics. The 1-year all-cause mortality rate, cardiovascular mortality, new permanent pacemaker implantation, valve-related reintervention, PVL (moderate or greater) was higher in the AR group than in the AS group,but there were no significant differences among these parameters. And the incidence of composite MAE (7.02% AS vs 5.89% AR) and the NHNA classifications\u0026thinsp;\u0026le;\u0026thinsp;II (84.11% AS vs 84.15% AR) were similar. LVEF, LV, IVST and LVPWT improved in both groups, except that the former two improved more significantly in AR group and the latter two improved more significantly in AS group, which may be attributed to both pathophysiologic features.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e\u003cp\u003eThis single-center study demonstrated the short-term safety and feasibility of the \u0026ldquo;off-label\u0026rdquo; TAVR device in patients with AR. In addition, it showed different degrees of improvement in LV structural and functional parameters in the two groups, which may be attributed to both pathophysiologic features.\u003c/p\u003e","manuscriptTitle":"One-Year Outcomes of “off-label” Transcatheter Devices in Native Aortic Regurgitations","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-07-14 10:55:28","doi":"10.21203/rs.3.rs-7001587/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"97fe01a9-562e-4340-8243-d598f50ee67a","owner":[],"postedDate":"July 14th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-08-18T14:39:20+00:00","versionOfRecord":[],"versionCreatedAt":"2025-07-14 10:55:28","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7001587","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7001587","identity":"rs-7001587","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}