First Dual-Center Clinical Experience With the Premounted Vienna Transcatheter Aortic Valve System: A Prospective Feasibility and Safety Study

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The Vienna valve is a next-generation, premounted self-expandable transcatheter heart valve designed to simplify procedural workflow and enhance deployment accuracy. Objective: To evaluate the feasibility, procedural safety, and early clinical and hemodynamic outcomes of the Vienna transcatheter aortic valve system in patients with severe symptomatic aortic stenosis. Method: This prospective, dual-center observational study enrolled 13 consecutive patients with severe symptomatic aortic stenosis who underwent transfemoral TAVI using the Vienna valve between February 2024 and July 2025. Clinical and echocardiographic assessments were performed at baseline, post-procedure, and during follow-up at 1 and 6 months. Primary endpoints were mortality, stroke, bleeding, pacemaker requirement, rehospitalization, and functional improvement. Outcomes were defined according to Valve Academic Research Consortium-3 criteria. Result: The mean patient age was 72 ± 9 years, and the mean EuroSCORE II was 6.7 ± 0.3%. Procedural success was achieved in 92.3% of cases. One intraprocedural cardiovascular death occurred due to valve infolding with cardiac tamponade. Mean transvalvular gradients decreased from 45.2 ± 19.0 mmHg at baseline to 11.7 ± 8.0 mmHg post-procedure and remained stable at 6 months. One patient (7.7%) required permanent pacemaker implantation during follow-up. No strokes, major bleeding events, or valve-related rehospitalizations were observed through 6 months. Conclusion: In this initial dual-center experience, the Vienna premounted self-expandable valve demonstrated encouraging feasibility, acceptable early safety, and sustained hemodynamic performance. Larger studies with longer follow-up are warranted to confirm long-term outcomes and durability. Vienna valve TAVI Self-expandable heart valve Transcatheter aortic valve implantation severe aortic stenosis Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Introduction Aortic stenosis (AS) is the most prevalent valvular heart disease in developed countries and remains a major cause of cardiovascular morbidity and mortality. Its prevalence increases markedly with age, affecting approximately 1–2% of individuals aged ≥ 65 years and more than 12% of those aged ≥ 75 years (1, 2). As population aging continues, the number of patients requiring aortic valve intervention is expected to rise substantially (3). Surgical aortic valve replacement (SAVR) has historically been the standard treatment for severe symptomatic AS. Over the past decade, however, transcatheter aortic valve implantation (TAVI) has transformed the management of this condition. Randomized trials across the surgical risk spectrum have demonstrated that transfemoral TAVI provides outcomes that are non-inferior, and in selected populations superior, to SAVR (4–6). Consequently, contemporary European and American guidelines now recommend TAVI as an alternative to surgery, with treatment selection guided by patient age, anatomical suitability, surgical risk, and patient preference (2, 7). Despite these advances, current transcatheter heart valve platforms are associated with technical challenges, including manual valve loading, prolonged preparation time, and the risk of procedural complications such as paravalvular regurgitation and conduction disturbances. These limitations underscore the need for next-generation devices designed to simplify procedural workflow while maintaining safety and favorable hemodynamic performance. The Vienna valve is a novel self-expanding, premounted transcatheter heart valve constructed on a nitinol frame with bovine pericardial leaflets. Its premounted configuration eliminates the need for intra-procedural crimping and aims to reduce operator-dependent variability. Early first-in-human experience has demonstrated high technical success and encouraging short-term outcomes .(8–10) Building on these initial findings, the present prospective dual-center study aimed to evaluate the feasibility, procedural safety, and early clinical and hemodynamic performance of the Vienna valve in patients with severe symptomatic aortic stenosis treated in a real-world clinical setting. Method Study Design and Population: This prospective, dual-center observational study included 13 consecutive patients with severe symptomatic aortic stenosis who underwent transfemoral TAVI using the Vienna self-expandable valve system between February 2024 and July 2025. Procedures were performed at Tehran Heart Center and Rajaie Cardiovascular Medical and Research Center. Eligible patients were adults with symptomatic severe aortic stenosis, defined by transthoracic echocardiography as an aortic valve area ≤ 1.0 cm² or indexed area ≤ 0.6 cm²/m², in combination with a mean gradient > 40 mmHg or peak velocity > 4.0 m/s, in accordance with the 2021 ESC/EACTS guidelines (11). Patients were considered candidates for TAVI if they were classified as intermediate or high surgical risk (EuroSCORE II ≥ 4%) or deemed unsuitable for surgery by the multidisciplinary Heart TeamFull inclusion and exclusion criteria are provided in the Supplementary Material. Device description: The Vienna self-expandable transcatheter aortic valve system (P + F Products & Features GmbH, Vienna, Austria) consists of a nitinol frame with three bovine pericardial leaflets and an external sealing skirt designed to reduce paravalvular regurgitation (Fig. 1 )(9). The valve is premounted on a 16-F delivery catheter compatible with a 20-F outer sheath and allows for resheathing and recapture prior to final deployment (Fig. 2 ) (9). All procedures were performed via transfemoral access under fluoroscopic and echocardiographic guidance using local anesthesia and conscious sedation. Valve sizing and procedural planning were based on multidetector computed tomography. Unfractionated heparin was administered to maintain an activated clotting time > 250 seconds. Post-deployment balloon dilatation was performed at the operator’s discretion. Procedural success and complications were defined according to Valve Academic Research Consortium-3 (VARC-3) criteria (12). Follow-up and Endpoints Baseline assessment included transthoracic echocardiography (TTE), computed tomography angiography (CTA), and electrocardiography (ECG). Immediate post-procedure TTE confirmed device positioning and absence of significant complications, including paravalvular leak, prosthesis malposition, or hemodynamic instability. Clinical and ECG monitoring continued during hospitalization. Follow-up at 1 and 6 months included clinical evaluation, ECG, and TTE, as recommended by VARC-3. Clinical outcomes were assessed using a standardized Major Adverse Cardiac Events (MACE) questionnaire (Supplementary Material). Primary endpoints included all-cause and cardiovascular mortality, stroke, major bleeding, permanent pacemaker implantation, and rehospitalization for valve-related or heart failure causes. Secondary endpoints included echocardiographic valve performance and New York Heart Association (NYHA) functional class. All clinical events were adjudicated by the local Heart Team at each center according to VARC-3 definitions. Statistical Analysis: Continuous variables are presented as mean ± standard deviation, and categorical variables as counts and percentages. Given the exploratory nature of this feasibility study and the limited sample size, analyses were descriptive and no hypothesis-driven inferential statistical testing was performed. Result Baseline Between February 2024 and July 2025, thirteen patients with severe symptomatic aortic stenosis underwent transfemoral TAVI using the Vienna valve. The mean age was 72 ± 9 years, and 46% of patients were male. Most patients were in NYHA functional class II (61.5%), while 38.5% were class III or IV (Table 1 ). The mean EuroSCORE II was 6.7 ± 0.3%, with the majority classified as intermediate surgical risk. Table 1 Baseline Clinical and Demographic Characteristics Patient ID Gender, age Body mass Euro score NYHA class LVEF pre DM history CAD history Prior PCI Prior CABG AF history Cerebrovascular history COPD history TIA history HTN anemia RF Peripheral vascular disease Lung disease Dyslipidemia P1 Male 70 22 3.10% class 2 55% No No No No No No No No No No No No No No P2 Female 61 20 4.22% class 2 60% No Yes Yes No No No No No Yes No No No Yes Yes P3 Female 83 29.29 19.45% class 2 50% No Yes No Yes No No No No Yes Yes Yes No Yes No P4 Female 58 39.4 4.40% class 3 55% No No No No No Yes No No No No No No No Yes P5 Male 59 17.3 2.82% class 2 60% No Yes No No Yes No Yes No Yes No No No Yes Yes P6 Female 78 35 4.01% class 2 55% No Yes Yes No No No No No Yes No No No No No P7 Male 67 27 5.22% class 3 25% No No No No No No No No No No No No No No P8 Male 85 29 6.29% class 2 45% No No No No No No No No Yes No No No No No P9 Female 74 19 7.73% class 3 25% No No Yes No No No No No Yes Yes No No No No P10 Male 72 22 12.86% class 3 NA Yes No No Yes No No No No No No No No No No P11 Female 82 NA 4.43% class 2 55% NA NA NA NA NA NA NA NA NA NA NA NA NA NA P12 Male 78 18 7.88% class 4 55% No No No No No No Yes No No Yes Yes No No No P13 Female 69 32.9 4.98% class 2 60% No No No No No No No No Yes No No No No Yes NA indicates data not available Baseline ECG revealed left bundle branch block in 15% and right bundle branch block in 8% of patients. Bicuspid morphology was present in 31% of CTA. Baseline echocardiography demonstrated a mean aortic valve area of 0.84 ± 0.26 cm² and a mean transvalvular gradient of 45.2 ± 19.0 mmHg. Mean left ventricular ejection fraction was 49 ± 12%. Bicuspid valve morphology was present in 31% of patients on computed tomography. Baseline clinical and imaging characteristics are summarized in Table 1 and Supplementary Table S1 . Procedural and Early Safety Outcomes: Procedural success was achieved in 12 of 13 patients (92.3%). Mean procedural time was 43.6 ± 5.5 minutes. One patient experienced valve infolding during the procedure, resulting in acute cardiac tamponade and intraprocedural cardiovascular death (Fig. 3 ). No other in-hospital strokes, major vascular complications, annular rupture, valve migration, or life-threatening bleeding events occurred (Table 2 ). Due to this intraprocedural mortality, 12 patients were available for 1-month follow-up. At 6 months, follow-up data were available for 11 patients, as one patient underwent TAVI less than two months before the end of the study period (Table S3, S4) Table 2 Procedural and Clinical Outcomes Post-operative hospitalization (n = 13) 30-days (n = 12) 6 months (n = 11) All-cause death 1 (7.7%) 0 (0%) 0 (0%) Cardiovascular death 1 (7.7%) 0 (0%) 0 (0%) Stroke 0 (0%) 0 (0%) 0 (0%) Acute kidney injury 0 (0%) 0 (0%) 0 (0%) Life-threatening bleeding 0 (0%) 0 (0%) 0 (0%) Hospitalization for valve-related Symptoms of congestive heart failure 0 (0%) 0 (0%) 0 (0%) Valve-related dysfunction requiring Repeat procedure 0 (0%) 0 (0%) 0 (0%) Conduction disturbances requiring permanent pacemaker implantation* 0 (0%) 0 (0%) 1 (7%) Data are displayed as n (%) *A patient with treatment-resistant sinus bradycardia necessitating permanent pacemaker implantation. †Given the periprocedural mortality, 12 patients got follow-up at one month, and one patient (P13) underwent TAVI two months ago; therefore, only one month follow up was performed for her. One patient (7.%) developed symptomatic bradycardia requiring permanent pacemaker implantation during follow-up. No additional conduction disturbances, strokes, or valve-related rehospitalizations were observed through 6 months. Patient enrollment, procedural outcomes, and follow-up availability are summarized in the study flow diagram (Fig. 5 ) Fluoroscopic imaging confirmed appropriate valve positioning and complete expansion in successfully treated patients (Fig. 4 ). Hemodynamic and Echocardiographic Outcomes: Mean transvalvular gradient decreased from 45.2 ± 19.0 mmHg at baseline to 11.7 ± 8.0 mmHg immediately post-procedure and remained stable at 6 months (11.9 ± 4.3 mmHg) (Fig. 6 ). Peak gradients demonstrated a similar sustained reduction. No patient developed moderate or severe paravalvular regurgitation during follow-up. Functional status improved in surviving patients, with a reduction in NYHA functional class observed at both 1- and 6-month follow-up visits. Detailed echocardiographic and clinical outcomes are provided in Tables 2 and Supplementary Tables S2–S4. Discussion A. Key Findings and Study Context The Vienna transcatheter aortic valve system is a novel premounted self-expanding valve utilizing dry-processed bovine pericardium and designed to simplify procedural workflow while maintaining contemporary safety and hemodynamic standards. First introduced in 2023, the device has previously demonstrated encouraging outcomes in first-in-human feasibility studies(13, 14). The present prospective dual-center study represents an early multicenter, real-world experience evaluating the feasibility, procedural safety, and short-term performance of the Vienna valve following initial first-in-human investigation. In a cohort of patients with predominantly intermediate surgical risk, the device demonstrated high procedural success, favorable hemodynamic performance, and acceptable early safety through 6-month follow-up. B. Eolution of Contemporary Transcatheter Aortic Valve Platforms The evolution of transcatheter aortic valve implantation has been driven by ongoing efforts to reduce paravalvular regurgitation, minimize conduction disturbances, and optimize valve hemodynamics. Contemporary balloon-expandable valves (BEVs) and self-expanding valves (SEVs), such as the SAPIEN 3 and Evolut R/PRO platforms, have demonstrated comparable clinical outcomes across a wide range of patient risk profiles. Large comparative analyses and meta-analyses have shown that SEVs generally provide lower transvalvular gradients and larger effective orifice areas, whereas BEVs are often associated with lower rates of paravalvular leak. Despite these differences, overall rates of mortality, stroke, major bleeding, and vascular complications are broadly similar between modern SEV and BEV platforms (15–17). C. Workflow and Procedural Efficiency The Vienna valve differs from many contemporary transcatheter heart valves by being premounted and utilizing dry-processed bovine pericardium, thereby eliminating the need for on-table crimping and reducing operator-dependent variability during valve preparation. In the present study, this premounted configuration translated into a streamlined procedural workflow, without device assembly–related complications. Similar workflow advantages were reported in the VIVA first-in-human feasibility study, which demonstrated high procedural success and absence of moderate or severe paravalvular regurgitation at 30 days (13). Procedural efficiency varies across transcatheter valve platforms and centers. Published registry and real-world data report mean procedural times ranging from approximately 60 to 80 minutes for contemporary self-expanding and balloon-expandable valves, including Evolut R, CoreValve, and SAPIEN 3 systems. In our cohort, the mean procedural time was 43.6 ± 5.5 minutes, which compares favorably with these reports and suggests that the premounted design may contribute to shorter case durations (18–20) D. Safety of Vienna valves: In this real-world cohort, one intraprocedural death occurred due to valve infolding during resheathing, resulting in acute cardiac tamponade and refractory hemodynamic collapse. This event corresponded to an in-hospital cardiovascular mortality rate of 7.7% (1/13). Aside from this complication, no other in-hospital or 30-day major adverse cardiac events were observed. At 6-month follow-up, one additional noncardiac death due to malignancy was recorded, resulting in a 6-month all-cause mortality rate of 7.7%. These outcomes are broadly consistent with early feasibility experiences involving novel transcatheter heart valves and fall within the wide range reported in higher-risk TAVI populations(21–23). The observed 6-month MACE rate of 15.3% compares favorably with the composite endpoint rates reported in landmark TAVI trials (24). Notably, no strokes, major bleeding events, valve thrombosis, endocarditis, or valve-related rehospitalizations were observed during follow-up. These findings align with contemporary VARC-3–based analyses and reported safety benchmarks for established transcatheter valve platforms (25–27). E. Conduction Disturbances and Safety Profile Permanent pacemaker implantation remains a clinically relevant limitation of self-expanding valve technology. Historically, SEVs have been associated with higher rates of new pacemaker implantation compared with BEVs, with reported rates ranging from 17% to 25% for earlier-generation SEVs versus approximately 6% to 8% for BEVs. In the present study, only one patient (7.7%) required permanent pacemaker implantation during follow-up. Although this rate is lower than many historical SEV reports, the small sample size precludes definitive conclusions. Nevertheless, these findings are consistent with a trend toward improved conduction outcomes observed with newer-generation self-expanding platforms. (20) F. Valve Infolding and Procedural Complications Valve infolding is an uncommon but increasingly recognized complication of self-expanding transcatheter valves and has been associated with severe annular or leaflet calcification, bicuspid valve anatomy, and interaction with stiff guidewires during repositioning attempts (28–30). Previously published case series and registries have emphasized the importance of careful wire selection and cautious manipulation during resheathing maneuvers, particularly in anatomically challenging cases. The occurrence of this complication in the present study underscores the learning curve associated with novel transcatheter valve platforms and highlights the need for meticulous procedural technique (28, 31–33). G. Hemodynamic Performance and Valve Function Hemodynamic performance following Vienna valve implantation was favorable and sustained throughout follow-up. All surviving patients met VARC-3 criteria for device success, with post-procedural mean transvalvular gradients remaining below 20 mmHg and no occurrence of moderate or severe paravalvular regurgitation at 1- or 6-month follow-up (12). Given the established association between residual paravalvular regurgitation and late mortality and reintervention, the absence of significant paravalvular leak in this cohort is clinically meaningful. This finding may reflect the valve’s external sealing skirt and supra-annular frame design, which are intended to optimize annular sealing and valve hemodynamics (34, 35). H. Early and Mid-Term Clinical Outcomes Notably, no strokes, major bleeding events, valve thrombosis, endocarditis, or valve-related rehospitalizations were recorded during follow-up. These outcomes compare favorably with historical TAVI benchmarks and align with VARC-3–based analyses of contemporary transcatheter valve platforms (12, 25, 27, 36) Survivors experienced improvement in functional status, as reflected by reductions in NYHA class, along with stable echocardiographic hemodynamics. Mean transvalvular gradients remained below 20 mmHg, and no new moderate or severe paravalvular regurgitation was observed through 6 months. These findings are concordant with the 6-month outcomes reported in the VIVA first-in-human study, although they should be interpreted cautiously given the limited sample size (13, 14). i. Functional Status and Patient-Reported Improvement Surviving patients experienced meaningful improvement in functional status, as reflected by reductions in NYHA functional class at both 1- and 6-month follow-up. Although formal quality-of-life instruments were not employed, these findings are consistent with symptomatic improvements reported in prior TAVI studies and reinforce the clinical benefit of effective relief of aortic stenosis (13, 14) J. Study Limitation: This study has several limitations. First, the sample size was small, reflecting the early feasibility nature of the investigation. Second, the absence of a comparator group limits direct comparisons with other commercially available transcatheter valves. Third, follow-up was limited to 6 months and does not permit assessment of long-term durability or late valve-related complications. Larger studies with extended follow-up and comparative designs are required to confirm these findings. Conclusion In this two-center study, we evaluated the initial safety and technical feasibility of the novel Vienna valve in thirteen high-surgical-risk patients with severe aortic stenosis. The Vienna premounted valve demonstrated encouraging feasibility, procedural safety, and hemodynamic durability at 6-month follow-up. While one intra-procedural mortality underscores the learning curve, overall outcomes suggest this platform may offer workflow and performance advantages in selected patients. These early multicenter results are encouraging; however, larger comparative studies are needed to confirm performance and durability of the Vienna valve within the contemporary TAVI landscape. Declarations Funding This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. The study was conducted using institutional resources only. Availability of data and materials The datasets generated and/or analyzed during the current study are not publicly available due to patient confidentiality and institutional data protection regulations but are available from the corresponding author on reasonable request. Ethics Statement This study was approved by the institutional ethics committees of Tehran Heart Center and Rajaie Cardiovascular Medical and Research Center (Ethics Code: IR.TUMS.THC.REC.1404.029). The study was conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent was obtained from all participants prior to enrollment. Competing interests The authors declare that they have no competing interests. References Aluru JS, Barsouk A, Saginala K, Rawla P, Barsouk A. Valvular Heart Disease Epidemiology. Med Sci (Basel). 2022;10(2). 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Strategic Management of Valve Infolding in Evolut TAVR Procedures: Enhancing Outcomes and Ensuring Patient Safety. J Soc Cardiovasc Angiogr Interv. 2024;3(12):102394. Durand E, Eltchaninoff H, Tchetche D, Levesque T, Garmendia C, Iung B, et al. Predictors of Outcomes of Reintervention After Transcatheter Aortic Valve Replacement: FRANCE 2 and FRANCE TAVI Registries. J Am Coll Cardiol. 2025;85(9):896-907. Makkar RR, Thourani VH, Mack MJ, Kodali SK, Kapadia S, Webb JG, et al. Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement. New England Journal of Medicine. 2020;382(9):799-809. Tomii D, Okuno T, Heg D, Lanz J, Praz F, Stortecky S, et al. Validation of the VARC-3 Technical Success Definition in Patients Undergoing TAVR. JACC Cardiovasc Interv. 2022;15(4):353-64. Additional Declarations No competing interests reported. Supplementary Files Supplementary.docx Cite Share Download PDF Status: Under Review Version 1 posted Reviews received at journal 20 Mar, 2026 Reviewers agreed at journal 20 Mar, 2026 Reviewers invited by journal 18 Mar, 2026 Editor invited by journal 20 Feb, 2026 Editor assigned by journal 19 Feb, 2026 Submission checks completed at journal 19 Feb, 2026 First submitted to journal 11 Feb, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-8854650","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":608392999,"identity":"62fc9a75-79aa-4dcb-9cbe-a58008ea1c76","order_by":0,"name":"Yaser Jenab","email":"","orcid":"","institution":"Tehran Heart Center, Tehran University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Yaser","middleName":"","lastName":"Jenab","suffix":""},{"id":608393004,"identity":"9f7604e9-5556-406d-a2e9-f2f9a7905d08","order_by":1,"name":"Ata Firouzi","email":"","orcid":"","institution":"Iran University of Medical Science","correspondingAuthor":false,"prefix":"","firstName":"Ata","middleName":"","lastName":"Firouzi","suffix":""},{"id":608393009,"identity":"b8e6998a-98d1-40dc-b64c-ec08a3a455f1","order_by":2,"name":"Mohammad Alidoosti","email":"","orcid":"","institution":"Tehran Heart Center, Tehran University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Mohammad","middleName":"","lastName":"Alidoosti","suffix":""},{"id":608393010,"identity":"426c9a00-bc73-4537-86c3-95089dc161e2","order_by":3,"name":"Armin Elahifar","email":"","orcid":"","institution":"Iran University of Medical Science","correspondingAuthor":false,"prefix":"","firstName":"Armin","middleName":"","lastName":"Elahifar","suffix":""},{"id":608393011,"identity":"747060f2-9303-4936-bcee-9f67fbc55cc1","order_by":4,"name":"Maede Mehdizadeh","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABFklEQVRIiWNgGAWjYJACCRBhwJDYwMDAxpDAD+IlFJCiRbIBpMWAKC0JDGAtBgcgXJxAt/3wwRsfKrbJmbMnN3/4UWaTZ3x+deKHBwYM8vxiB7BqMTuTlmw548xtY8uehw2GPefSis1uvN0sAXSY4czZCdi1HMgxk+Ztu5244UZiQwJv2+HEbTfObgBpSTC4jUPL+fffpP/+u10P0nLwb9v/xM0zzm7+gVfLjRw2acaG2wkGNxIbm3nbDiRu4O/dht+WG8+A3jh223DDmYfNzDLnkhNn3ODdZpFgIIHbL+eTH974UXNb3uB4+uOPb8rsEvv7z26++aPCRp5fGrsWLEACrFKCWOUgwH+AFNWjYBSMglEwAgAAHjNwAFTfR5wAAAAASUVORK5CYII=","orcid":"","institution":"Tehran Heart Center, Tehran University of Medical Sciences","correspondingAuthor":true,"prefix":"","firstName":"Maede","middleName":"","lastName":"Mehdizadeh","suffix":""},{"id":608393012,"identity":"559acb6c-638f-4136-b366-2dadd9e19bf5","order_by":5,"name":"Mojtaba Salarifar","email":"","orcid":"","institution":"Tehran Heart Center, Tehran University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Mojtaba","middleName":"","lastName":"Salarifar","suffix":""},{"id":608393013,"identity":"11fd2de4-333c-43f5-a456-e3ec5e032e44","order_by":6,"name":"Reza Nikfar","email":"","orcid":"","institution":"Tehran Heart Center, Tehran University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Reza","middleName":"","lastName":"Nikfar","suffix":""},{"id":608393015,"identity":"f669f9c2-3d18-4c75-86a0-cecd375f1162","order_by":7,"name":"Fatemeh Bahreini","email":"","orcid":"","institution":"Tehran Heart Center, Tehran University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Fatemeh","middleName":"","lastName":"Bahreini","suffix":""},{"id":608393016,"identity":"d72c7772-27c7-4148-8f92-a0694fe82678","order_by":8,"name":"Najme-Sadat Moosavi","email":"","orcid":"","institution":"Tehran University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Najme-Sadat","middleName":"","lastName":"Moosavi","suffix":""},{"id":608393017,"identity":"e54c8faa-5f35-452e-a1e7-6fddf70a2e17","order_by":9,"name":"Arezoo Zoroufian","email":"","orcid":"","institution":"Tehran Heart Center, Tehran University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Arezoo","middleName":"","lastName":"Zoroufian","suffix":""},{"id":608393018,"identity":"bf270290-f382-4f22-8291-caffc71e30cb","order_by":10,"name":"Reza Mohseni","email":"","orcid":"","institution":"Tehran Heart Center, Tehran University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Reza","middleName":"","lastName":"Mohseni","suffix":""}],"badges":[],"createdAt":"2026-02-11 17:54:22","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8854650/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8854650/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":105150361,"identity":"1fa7106c-eeb3-4c25-a6ad-4abe3bff8aff","added_by":"auto","created_at":"2026-03-22 15:01:45","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":330169,"visible":true,"origin":"","legend":"\u003cp\u003eThe Vienna self-expandable transcatheter aortic valve system. (A) Outflow view, (B) inflow view, and (C) lateral view demonstrating the nitinol frame and bovine pericardial leaflets.\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-8854650/v1/aff018b56519ee7647a2652b.png"},{"id":105563404,"identity":"002d7d98-e4ce-4a9e-94db-de4859cf5ce6","added_by":"auto","created_at":"2026-03-27 12:46:54","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":139442,"visible":true,"origin":"","legend":"\u003cp\u003eDelivery system of the Vienna transcatheter aortic valve, illustrating the premounted valve configuration and deployment mechanism.\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-8854650/v1/c1d843ec2e531078fc18bc1e.png"},{"id":105150366,"identity":"5640f936-5da1-4021-b7e5-327f06bbdf27","added_by":"auto","created_at":"2026-03-22 15:01:45","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":255827,"visible":true,"origin":"","legend":"\u003cp\u003eIntra-procedural valve infolding with incomplete expansion of the self-expandable transcatheter valve following resheathing, resulting in hemodynamic compromise.\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-8854650/v1/2eb461cea3b8836cde0b6e4e.png"},{"id":105150365,"identity":"c3244b26-e59f-49d5-9872-37c7b8c54245","added_by":"auto","created_at":"2026-03-22 15:01:45","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":302403,"visible":true,"origin":"","legend":"\u003cp\u003eRepresentative fluoroscopic image demonstrating correct positioning and full expansion of the Vienna transcatheter aortic valve after deployment.\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-8854650/v1/1fe58fe1f4e84fe8ab8d8e3b.png"},{"id":105563752,"identity":"7f5edcd7-4c1f-451d-aa7b-1687bbac4c1e","added_by":"auto","created_at":"2026-03-27 12:47:43","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":128673,"visible":true,"origin":"","legend":"\u003cp\u003eStudy flow diagram illustrating patient enrollment and follow-up availability at post-procedure, 1-month, and 6-month assessments\u003c/p\u003e","description":"","filename":"floatimage4.png","url":"https://assets-eu.researchsquare.com/files/rs-8854650/v1/35c11aadb767ce3edcdff284.png"},{"id":105563735,"identity":"b45c67a6-e209-40e2-947a-baefc9a8756b","added_by":"auto","created_at":"2026-03-27 12:47:38","extension":"png","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":368336,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eChanges in peak and mean transaortic valve gradients before TAVI, immediately post-procedure, and at 1- and 6-month follow-up.\u003c/em\u003e\u003c/p\u003e","description":"","filename":"floatimage5.png","url":"https://assets-eu.researchsquare.com/files/rs-8854650/v1/ce23c5b9e97c447eeea8ab5c.png"},{"id":106723681,"identity":"8b04d71c-5526-41c1-9957-68283fa4d963","added_by":"auto","created_at":"2026-04-12 18:11:05","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2582309,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8854650/v1/1b9f51ec-86f2-4863-9080-1e70f7175753.pdf"},{"id":105150362,"identity":"44b62205-be8f-4236-82d2-44924615476b","added_by":"auto","created_at":"2026-03-22 15:01:45","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":59411,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementary.docx","url":"https://assets-eu.researchsquare.com/files/rs-8854650/v1/e1e1738303f5c68001015082.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"First Dual-Center Clinical Experience With the Premounted Vienna Transcatheter Aortic Valve System: A Prospective Feasibility and Safety Study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eAortic stenosis (AS) is the most prevalent valvular heart disease in developed countries and remains a major cause of cardiovascular morbidity and mortality. Its prevalence increases markedly with age, affecting approximately 1\u0026ndash;2% of individuals aged\u0026thinsp;\u0026ge;\u0026thinsp;65 years and more than 12% of those aged\u0026thinsp;\u0026ge;\u0026thinsp;75 years (1, 2). As population aging continues, the number of patients requiring aortic valve intervention is expected to rise substantially (3).\u003c/p\u003e \u003cp\u003eSurgical aortic valve replacement (SAVR) has historically been the standard treatment for severe symptomatic AS. Over the past decade, however, transcatheter aortic valve implantation (TAVI) has transformed the management of this condition. Randomized trials across the surgical risk spectrum have demonstrated that transfemoral TAVI provides outcomes that are non-inferior, and in selected populations superior, to SAVR (4\u0026ndash;6). Consequently, contemporary European and American guidelines now recommend TAVI as an alternative to surgery, with treatment selection guided by patient age, anatomical suitability, surgical risk, and patient preference (2, 7).\u003c/p\u003e \u003cp\u003eDespite these advances, current transcatheter heart valve platforms are associated with technical challenges, including manual valve loading, prolonged preparation time, and the risk of procedural complications such as paravalvular regurgitation and conduction disturbances. These limitations underscore the need for next-generation devices designed to simplify procedural workflow while maintaining safety and favorable hemodynamic performance.\u003c/p\u003e \u003cp\u003eThe Vienna valve is a novel self-expanding, premounted transcatheter heart valve constructed on a nitinol frame with bovine pericardial leaflets. Its premounted configuration eliminates the need for intra-procedural crimping and aims to reduce operator-dependent variability. Early first-in-human experience has demonstrated high technical success and encouraging short-term outcomes .(8\u0026ndash;10)\u003c/p\u003e \u003cp\u003eBuilding on these initial findings, the present prospective dual-center study aimed to evaluate the feasibility, procedural safety, and early clinical and hemodynamic performance of the Vienna valve in patients with severe symptomatic aortic stenosis treated in a real-world clinical setting.\u003c/p\u003e"},{"header":"Method","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design and Population:\u003c/h2\u003e \u003cp\u003eThis prospective, dual-center observational study included 13 consecutive patients with severe symptomatic aortic stenosis who underwent transfemoral TAVI using the Vienna self-expandable valve system between February 2024 and July 2025. Procedures were performed at Tehran Heart Center and Rajaie Cardiovascular Medical and Research Center.\u003c/p\u003e \u003cp\u003eEligible patients were adults with symptomatic severe aortic stenosis, defined by transthoracic echocardiography as an aortic valve area ≤ 1.0 cm² or indexed area ≤ 0.6 cm²/m², in combination with a mean gradient \u0026gt; 40 mmHg or peak velocity \u0026gt; 4.0 m/s, in accordance with the 2021 ESC/EACTS guidelines (11).\u003c/p\u003e \u003cp\u003ePatients were considered candidates for TAVI if they were classified as intermediate or high surgical risk (EuroSCORE II ≥ 4%) or deemed unsuitable for surgery by the multidisciplinary Heart TeamFull inclusion and exclusion criteria are provided in the Supplementary Material.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eDevice description:\u003c/h3\u003e\n\u003cp\u003eThe Vienna self-expandable transcatheter aortic valve system (P + F Products \u0026amp; Features GmbH, Vienna, Austria) consists of a nitinol frame with three bovine pericardial leaflets and an external sealing skirt designed to reduce paravalvular regurgitation (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e)(9).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe valve is premounted on a 16-F delivery catheter compatible with a 20-F outer sheath and allows for resheathing and recapture prior to final deployment (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e) (9).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e\n\n \u003cp\u003eAll procedures were performed via transfemoral access under fluoroscopic and echocardiographic guidance using local anesthesia and conscious sedation. Valve sizing and procedural planning were based on multidetector computed tomography. Unfractionated heparin was administered to maintain an activated clotting time \u0026gt; 250 seconds. Post-deployment balloon dilatation was performed at the operator’s discretion. Procedural success and complications were defined according to Valve Academic Research Consortium-3 (VARC-3) criteria (12).\u003c/p\u003e\n\u003ch3\u003eFollow-up and Endpoints\u003c/h3\u003e\n\u003cp\u003eBaseline assessment included transthoracic echocardiography (TTE), computed tomography angiography (CTA), and electrocardiography (ECG). Immediate post-procedure TTE confirmed device positioning and absence of significant complications, including paravalvular leak, prosthesis malposition, or hemodynamic instability. Clinical and ECG monitoring continued during hospitalization. Follow-up at 1 and 6 months included clinical evaluation, ECG, and TTE, as recommended by VARC-3. Clinical outcomes were assessed using a standardized Major Adverse Cardiac Events (MACE) questionnaire (Supplementary Material).\u003c/p\u003e \u003cp\u003ePrimary endpoints included all-cause and cardiovascular mortality, stroke, major bleeding, permanent pacemaker implantation, and rehospitalization for valve-related or heart failure causes. Secondary endpoints included echocardiographic valve performance and New York Heart Association (NYHA) functional class. All clinical events were adjudicated by the local Heart Team at each center according to VARC-3 definitions.\u003c/p\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis:\u003c/h2\u003e \u003cp\u003eContinuous variables are presented as mean ± standard deviation, and categorical variables as counts and percentages. Given the exploratory nature of this feasibility study and the limited sample size, analyses were descriptive and no hypothesis-driven inferential statistical testing was performed.\u003c/p\u003e \u003c/div\u003e"},{"header":"Result","content":"\u003ch2\u003eBaseline\u003c/h2\u003e\u003cp\u003eBetween February 2024 and July 2025, thirteen patients with severe symptomatic aortic stenosis underwent transfemoral TAVI using the Vienna valve. The mean age was 72 ± 9 years, and 46% of patients were male. Most patients were in NYHA functional class II (61.5%), while 38.5% were class III or IV (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e). The mean EuroSCORE II was 6.7 ± 0.3%, with the majority classified as intermediate surgical risk.\u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003ctable id=\"Tab1\" border=\"1\"\u003e \u003ccaption\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline Clinical and Demographic Characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"20\"\u003e \u003c/colgroup\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\"\u003e \u003cp\u003ePatient ID\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eGender, age\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eBody mass\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eEuro score\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eNYHA class\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eLVEF pre\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eDM history\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eCAD history\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003ePrior PCI\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003ePrior CABG\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eAF history\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eCerebrovascular history\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eCOPD history\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eTIA history\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eHTN\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eanemia\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eRF\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003ePeripheral vascular disease\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eLung disease\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003eDyslipidemia\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eP1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eMale 70\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\"\u003e \u003cp\u003e3.10%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eclass 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e55%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eP2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eFemale 61\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\"\u003e \u003cp\u003e4.22%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eclass 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e60%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eP3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eFemale 83\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e29.29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\"\u003e \u003cp\u003e19.45%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eclass 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e50%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eP4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eFemale 58\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e39.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\"\u003e \u003cp\u003e4.40%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eclass 3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e55%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eP5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eMale 59\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e17.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\"\u003e \u003cp\u003e2.82%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eclass 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e60%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eP6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eFemale 78\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\"\u003e \u003cp\u003e4.01%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eclass 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e55%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eP7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eMale 67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\"\u003e \u003cp\u003e5.22%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eclass 3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e25%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eP8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eMale 85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\"\u003e \u003cp\u003e6.29%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eclass 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e45%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eP9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eFemale 74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\"\u003e \u003cp\u003e7.73%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eclass 3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e25%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eP10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eMale 72\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\"\u003e \u003cp\u003e12.86%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eclass 3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eP11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eFemale 82\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\"\u003e \u003cp\u003e4.43%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eclass 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e55%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eP12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eMale 78\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\"\u003e \u003cp\u003e7.88%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eclass 4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e55%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eP13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003cp\u003e69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e32.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\"\u003e \u003cp\u003e4.98%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eclass 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e60%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"20\"\u003eNA indicates data not available\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e\u003cp\u003eBaseline ECG revealed left bundle branch block in 15% and right bundle branch block in 8% of patients. Bicuspid morphology was present in 31% of CTA. Baseline echocardiography demonstrated a mean aortic valve area of 0.84 ± 0.26 cm² and a mean transvalvular gradient of 45.2 ± 19.0 mmHg. Mean left ventricular ejection fraction was 49 ± 12%. Bicuspid valve morphology was present in 31% of patients on computed tomography. Baseline clinical and imaging characteristics are summarized in Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e and Supplementary Table \u003cspan class=\"InternalRef\"\u003eS1\u003c/span\u003e.\u003c/p\u003e\u003ch3\u003eProcedural and Early Safety Outcomes:\u003c/h3\u003e\u003cp\u003eProcedural success was achieved in 12 of 13 patients (92.3%). Mean procedural time was 43.6 ± 5.5 minutes. One patient experienced valve infolding during the procedure, resulting in acute cardiac tamponade and intraprocedural cardiovascular death (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e). No other in-hospital strokes, major vascular complications, annular rupture, valve migration, or life-threatening bleeding events occurred (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e). Due to this intraprocedural mortality, 12 patients were available for 1-month follow-up. At 6 months, follow-up data were available for 11 patients, as one patient underwent TAVI less than two months before the end of the study period (Table S3, S4)\u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\"\u003e\u003c/div\u003e\u003ctable id=\"Tab2\" border=\"1\"\u003e \u003ccaption\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eProcedural and Clinical Outcomes\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003c/colgroup\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003ePost-operative hospitalization\u003c/p\u003e \u003cp\u003e(n = 13)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003e30-days\u003c/p\u003e \u003cp\u003e(n = 12)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\"\u003e \u003cp\u003e6 months\u003c/p\u003e \u003cp\u003e(n = 11)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eAll-cause death\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e1 (7.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eCardiovascular death\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e1 (7.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eStroke\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eAcute kidney injury\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eLife-threatening bleeding\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eHospitalization for valve-related\u003c/p\u003e \u003cp\u003e Symptoms of congestive heart failure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eValve-related dysfunction requiring\u003c/p\u003e \u003cp\u003eRepeat procedure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\"\u003e \u003cp\u003eConduction disturbances requiring\u003c/p\u003e \u003cp\u003epermanent pacemaker implantation*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\"\u003e \u003cp\u003e1 (7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/table\u003e\u003c/div\u003e\u003cp\u003eData are displayed as n (%)\u003cbr\u003e*A patient with treatment-resistant sinus bradycardia necessitating permanent pacemaker implantation.\u003cbr\u003e\u0026nbsp;\u0026dagger;Given the periprocedural mortality, 12 patients got follow-up at one month, and one patient (P13) \u0026nbsp;underwent TAVI two months ago; therefore, only one month follow up was performed for her.\u003c/p\u003e\u003cp\u003eOne patient (7.%) developed symptomatic bradycardia requiring permanent pacemaker implantation during follow-up. No additional conduction disturbances, strokes, or valve-related rehospitalizations were observed through 6 months. Patient enrollment, procedural outcomes, and follow-up availability are summarized in the study flow diagram (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eFluoroscopic imaging confirmed appropriate valve positioning and complete expansion in successfully treated patients (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\u003ch2\u003eHemodynamic and Echocardiographic Outcomes:\u003c/h2\u003e\u003cp\u003eMean transvalvular gradient decreased from 45.2 ± 19.0 mmHg at baseline to 11.7 ± 8.0 mmHg immediately post-procedure and remained stable at 6 months (11.9 ± 4.3 mmHg) (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e6\u003c/span\u003e). Peak gradients demonstrated a similar sustained reduction. No patient developed moderate or severe paravalvular regurgitation during follow-up.\u003c/p\u003e\u003cp\u003eFunctional status improved in surviving patients, with a reduction in NYHA functional class observed at both 1- and 6-month follow-up visits. Detailed echocardiographic and clinical outcomes are provided in Tables\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e and Supplementary Tables S2–S4.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eA. Key Findings and Study Context\u003c/h2\u003e \u003cp\u003eThe Vienna transcatheter aortic valve system is a novel premounted self-expanding valve utilizing dry-processed bovine pericardium and designed to simplify procedural workflow while maintaining contemporary safety and hemodynamic standards. First introduced in 2023, the device has previously demonstrated encouraging outcomes in first-in-human feasibility studies(13, 14).\u003c/p\u003e \u003cp\u003eThe present prospective dual-center study represents an early multicenter, real-world experience evaluating the feasibility, procedural safety, and short-term performance of the Vienna valve following initial first-in-human investigation. In a cohort of patients with predominantly intermediate surgical risk, the device demonstrated high procedural success, favorable hemodynamic performance, and acceptable early safety through 6-month follow-up.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eB. Eolution of Contemporary Transcatheter Aortic Valve Platforms\u003c/h2\u003e \u003cp\u003eThe evolution of transcatheter aortic valve implantation has been driven by ongoing efforts to reduce paravalvular regurgitation, minimize conduction disturbances, and optimize valve hemodynamics. Contemporary balloon-expandable valves (BEVs) and self-expanding valves (SEVs), such as the SAPIEN 3 and Evolut R/PRO platforms, have demonstrated comparable clinical outcomes across a wide range of patient risk profiles.\u003c/p\u003e \u003cp\u003eLarge comparative analyses and meta-analyses have shown that SEVs generally provide lower transvalvular gradients and larger effective orifice areas, whereas BEVs are often associated with lower rates of paravalvular leak. Despite these differences, overall rates of mortality, stroke, major bleeding, and vascular complications are broadly similar between modern SEV and BEV platforms (15\u0026ndash;17).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eC. Workflow and Procedural Efficiency\u003c/h2\u003e \u003cp\u003eThe Vienna valve differs from many contemporary transcatheter heart valves by being premounted and utilizing dry-processed bovine pericardium, thereby eliminating the need for on-table crimping and reducing operator-dependent variability during valve preparation. In the present study, this premounted configuration translated into a streamlined procedural workflow, without device assembly\u0026ndash;related complications. Similar workflow advantages were reported in the VIVA first-in-human feasibility study, which demonstrated high procedural success and absence of moderate or severe paravalvular regurgitation at 30 days (13).\u003c/p\u003e \u003cp\u003eProcedural efficiency varies across transcatheter valve platforms and centers. Published registry and real-world data report mean procedural times ranging from approximately 60 to 80 minutes for contemporary self-expanding and balloon-expandable valves, including Evolut R, CoreValve, and SAPIEN 3 systems. In our cohort, the mean procedural time was 43.6\u0026thinsp;\u0026plusmn;\u0026thinsp;5.5 minutes, which compares favorably with these reports and suggests that the premounted design may contribute to shorter case durations (18\u0026ndash;20)\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eD. Safety of Vienna valves:\u003c/h2\u003e \u003cp\u003eIn this real-world cohort, one intraprocedural death occurred due to valve infolding during resheathing, resulting in acute cardiac tamponade and refractory hemodynamic collapse. This event corresponded to an in-hospital cardiovascular mortality rate of 7.7% (1/13). Aside from this complication, no other in-hospital or 30-day major adverse cardiac events were observed.\u003c/p\u003e \u003cp\u003eAt 6-month follow-up, one additional noncardiac death due to malignancy was recorded, resulting in a 6-month all-cause mortality rate of 7.7%. These outcomes are broadly consistent with early feasibility experiences involving novel transcatheter heart valves and fall within the wide range reported in higher-risk TAVI populations(21\u0026ndash;23). The observed 6-month MACE rate of 15.3% compares favorably with the composite endpoint rates reported in landmark TAVI trials (24).\u003c/p\u003e \u003cp\u003eNotably, no strokes, major bleeding events, valve thrombosis, endocarditis, or valve-related rehospitalizations were observed during follow-up. These findings align with contemporary VARC-3\u0026ndash;based analyses and reported safety benchmarks for established transcatheter valve platforms (25\u0026ndash;27).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eE. Conduction Disturbances and Safety Profile\u003c/h2\u003e \u003cp\u003ePermanent pacemaker implantation remains a clinically relevant limitation of self-expanding valve technology. Historically, SEVs have been associated with higher rates of new pacemaker implantation compared with BEVs, with reported rates ranging from 17% to 25% for earlier-generation SEVs versus approximately 6% to 8% for BEVs.\u003c/p\u003e \u003cp\u003eIn the present study, only one patient (7.7%) required permanent pacemaker implantation during follow-up. Although this rate is lower than many historical SEV reports, the small sample size precludes definitive conclusions. Nevertheless, these findings are consistent with a trend toward improved conduction outcomes observed with newer-generation self-expanding platforms. (20)\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eF. Valve Infolding and Procedural Complications\u003c/h2\u003e \u003cp\u003eValve infolding is an uncommon but increasingly recognized complication of self-expanding transcatheter valves and has been associated with severe annular or leaflet calcification, bicuspid valve anatomy, and interaction with stiff guidewires during repositioning attempts (28\u0026ndash;30).\u003c/p\u003e \u003cp\u003ePreviously published case series and registries have emphasized the importance of careful wire selection and cautious manipulation during resheathing maneuvers, particularly in anatomically challenging cases. The occurrence of this complication in the present study underscores the learning curve associated with novel transcatheter valve platforms and highlights the need for meticulous procedural technique (28, 31\u0026ndash;33).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eG. Hemodynamic Performance and Valve Function\u003c/h2\u003e \u003cp\u003eHemodynamic performance following Vienna valve implantation was favorable and sustained throughout follow-up. All surviving patients met VARC-3 criteria for device success, with post-procedural mean transvalvular gradients remaining below 20 mmHg and no occurrence of moderate or severe paravalvular regurgitation at 1- or 6-month follow-up (12).\u003c/p\u003e \u003cp\u003eGiven the established association between residual paravalvular regurgitation and late mortality and reintervention, the absence of significant paravalvular leak in this cohort is clinically meaningful. This finding may reflect the valve\u0026rsquo;s external sealing skirt and supra-annular frame design, which are intended to optimize annular sealing and valve hemodynamics (34, 35).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eH. Early and Mid-Term Clinical Outcomes\u003c/h2\u003e \u003cp\u003eNotably, no strokes, major bleeding events, valve thrombosis, endocarditis, or valve-related rehospitalizations were recorded during follow-up. These outcomes compare favorably with historical TAVI benchmarks and align with VARC-3\u0026ndash;based analyses of contemporary transcatheter valve platforms (12, 25, 27, 36)\u003c/p\u003e \u003cp\u003eSurvivors experienced improvement in functional status, as reflected by reductions in NYHA class, along with stable echocardiographic hemodynamics. Mean transvalvular gradients remained below 20 mmHg, and no new moderate or severe paravalvular regurgitation was observed through 6 months. These findings are concordant with the 6-month outcomes reported in the VIVA first-in-human study, although they should be interpreted cautiously given the limited sample size (13, 14).\u003c/p\u003e \u003cp\u003e \u003cp\u003ei. Functional Status and Patient-Reported Improvement \u003c/p\u003e \u003cp\u003eSurviving patients experienced meaningful improvement in functional status, as reflected by reductions in NYHA functional class at both 1- and 6-month follow-up. Although formal quality-of-life instruments were not employed, these findings are consistent with symptomatic improvements reported in prior TAVI studies and reinforce the clinical benefit of effective relief of aortic stenosis (13, 14)\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eJ. Study Limitation:\u003c/h2\u003e \u003cp\u003eThis study has several limitations. First, the sample size was small, reflecting the early feasibility nature of the investigation. Second, the absence of a comparator group limits direct comparisons with other commercially available transcatheter valves. Third, follow-up was limited to 6 months and does not permit assessment of long-term durability or late valve-related complications. Larger studies with extended follow-up and comparative designs are required to confirm these findings.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eIn this two-center study, we evaluated the initial safety and technical feasibility of the novel Vienna valve in thirteen high-surgical-risk patients with severe aortic stenosis. The Vienna premounted valve demonstrated encouraging feasibility, procedural safety, and hemodynamic durability at 6-month follow-up. While one intra-procedural mortality underscores the learning curve, overall outcomes suggest this platform may offer workflow and performance advantages in selected patients.\u003c/p\u003e \u003cp\u003eThese early multicenter results are encouraging; however, larger comparative studies are needed to confirm performance and durability of the Vienna valve within the contemporary TAVI landscape.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. The study was conducted using institutional resources only.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and/or analyzed during the current study are not publicly available due to patient confidentiality and institutional data protection regulations but are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was approved by the institutional ethics committees of Tehran Heart Center and Rajaie Cardiovascular Medical and Research Center (Ethics Code: IR.TUMS.THC.REC.1404.029). The study was conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent was obtained from all participants prior to enrollment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eAluru JS, Barsouk A, Saginala K, Rawla P, Barsouk A. Valvular Heart Disease Epidemiology. Med Sci (Basel). 2022;10(2).\u003c/li\u003e\n\u003cli\u003eVahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022;43(7):561-632.\u003c/li\u003e\n\u003cli\u003eFalk V, Baumgartner H, Bax JJ, De Bonis M, Hamm C, Holm PJ, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur J Cardiothorac Surg. 2017;52(4):616-64.\u003c/li\u003e\n\u003cli\u003eMack Michael J, Leon Martin B, Thourani Vinod H, Pibarot P, Hahn Rebecca T, Genereux P, et al. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years. New England Journal of Medicine. 2023;389(21):1949-60.\u003c/li\u003e\n\u003cli\u003eLeon Martin B, Smith Craig R, Mack M, Miller DC, Moses Jeffrey W, Svensson Lars G, et al. Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery. New England Journal of Medicine.363(17):1597-607.\u003c/li\u003e\n\u003cli\u003eLeon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, et al. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. New England Journal of Medicine. 2016;374(17):1609-20.\u003c/li\u003e\n\u003cli\u003eOtto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP, Gentile F, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021;143(5):e72-e227.\u003c/li\u003e\n\u003cli\u003eBriedis K, Aldujeli A, Zaliunas R, Benetis R. Early Safety and Performance of the Premounted Dry-Pericardium Vienna Self-Expandable Transcatheter Aortic Valve System: 30-Day Outcomes of the First-in-Human VIVA Feasibility Study. Am J Cardiol. 2023;204:302-11.\u003c/li\u003e\n\u003cli\u003eBriedis K, Mizariene V, Rumbinaite E, Jurenas M, Aldujeli A, Briede K, et al. Safety and performance of the Vienna self-expandable transcatheter aortic valve system: 6-month results of the VIVA first-in-human feasibility study. Front Cardiovasc Med. 2023;10:1199047.\u003c/li\u003e\n\u003cli\u003eBriedis K, Rumbinaite E, Aldujeli A, Briede K, Jurenas M, Jakuska P, et al. One-year initial efficacy and safety outcomes of the premounted dry-pericardium Vienna self-expandable transcatheter aortic valve system: A first-in-human VIVA feasibility study. Catheter Cardiovasc Interv. 2024;103(7):1111-24.\u003c/li\u003e\n\u003cli\u003eVahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease: Developed by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). European Heart Journal. 2022;43(7):561-632.\u003c/li\u003e\n\u003cli\u003enull n, G\u0026eacute;n\u0026eacute;reux P, Piazza N, Alu Maria C, Nazif T, Hahn Rebecca T, et al. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. JACC. 2021;77(21):2717-46.\u003c/li\u003e\n\u003cli\u003eBriedis K, Mizarienė V, Rumbinaitė E, Jurėnas M, Aldujeli A, Briedė K, et al. Safety and performance of the Vienna self-expandable transcatheter aortic valve system: 6-month results of the VIVA first-in-human feasibility study. Frontiers in Cardiovascular Medicine. 2023;10.\u003c/li\u003e\n\u003cli\u003eBriedis K, Rumbinaite E, Aldujeli A, Briede K, Jurenas M, Jakuska P, et al. One-year initial efficacy and safety outcomes of the premounted dry-pericardium Vienna self-expandable transcatheter aortic valve system: A first-in-human VIVA feasibility study. Catheterization and Cardiovascular Interventions. 2024;103(7):1111-24.\u003c/li\u003e\n\u003cli\u003eWang B, Mei Z, Ge X, Li Y, Zhou Q, Meng X, et al. Comparison of outcomes of self-expanding versus balloon-expandable valves for transcatheter aortic valve replacement: a meta-analysis of randomized and propensity-matched studies. BMC Cardiovasc Disord. 2023;23(1):382.\u003c/li\u003e\n\u003cli\u003eDeharo P, Bisson A, Herbert J, Lacour T, Saint Etienne C, Grammatico-Guillon L, et al. Impact of Sapien 3 Balloon-Expandable Versus Evolut R Self-Expandable Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis. Circulation. 2020;141(4):260-8.\u003c/li\u003e\n\u003cli\u003eRheude T, Pellegrini C, Allali A, Bleiziffer S, Kim W-K, Neuser J, et al. Multicenter comparison of latest-generation balloon-expandable versus self-expanding transcatheter heart valves: Ultra versus Evolut. International Journal of Cardiology. 2022;357:115-20.\u003c/li\u003e\n\u003cli\u003eNoble S, Stortecky S, Heg D, Tueller D, Jeger RV, Toggweiler S, et al. Comparison of procedural and clinical outcomes with Evolut R versus Medtronic CoreValve: a Swiss TAVI registry analysis. EuroIntervention. 2017;12(18):e2170-e6.\u003c/li\u003e\n\u003cli\u003eStinis Curtiss T, Abbas Amr E, Teirstein P, Makkar Raj R, Chung Christine J, Iyer V, et al. Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States. JACC: Cardiovascular Interventions. 2024;17(8):1032-44.\u003c/li\u003e\n\u003cli\u003eS\u0026aacute; MP, Jacquemyn X, Sun T, Van den Eynde J, Tasoudis P, Erten O, et al. Late Outcomes of Permanent Pacemaker Implantation After TAVR: Meta-analysis of Reconstructed Time-to-Event Data. J Soc Cardiovasc Angiogr Interv. 2022;1(5):100434.\u003c/li\u003e\n\u003cli\u003eStrange JE, Fosb\u0026oslash;l EL, Sindet-Pedersen C, Havers-Borgersen E, K\u0026oslash;ber L, Gislason GH, et al. Mortality at one year after transcatheter aortic valve replacement - Relation of age and comorbidities. Int J Cardiol Heart Vasc. 2022;43:101157.\u003c/li\u003e\n\u003cli\u003eGilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012;366(18):1705-15.\u003c/li\u003e\n\u003cli\u003eAdams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis. New England Journal of Medicine. 2014;370(19):1790-8.\u003c/li\u003e\n\u003cli\u003eArnold SV, Reynolds MR, Lei Y, Magnuson EA, Kirtane AJ, Kodali SK, et al. Predictors of poor outcomes after transcatheter aortic valve replacement: results from the PARTNER (Placement of Aortic Transcatheter Valve) trial. Circulation. 2014;129(25):2682-90.\u003c/li\u003e\n\u003cli\u003eEggebrecht H, Schmermund A, Voigtl T, Kahlert P, Erbel R, Mehta RH. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention. 2012;8(1):129-38.\u003c/li\u003e\n\u003cli\u003eAvvedimento M, Cepas-Guill\u0026eacute;n P, Ternacle J, Urena M, Alperi A, Cheema A, et al. Validation of the Valve Academic Research Consortium High Bleeding Risk Definition in Patients Undergoing TAVR. Circulation: Cardiovascular Interventions. 2025;18(1):e014800.\u003c/li\u003e\n\u003cli\u003eGarot P, Neylon A, Morice MC, Tamburino C, Bleiziffer S, Thiele H, et al. Bleeding risk differences after TAVR according to the ARC-HBR criteria: insights from SCOPE 2. EuroIntervention. 2022;18(6):503-13.\u003c/li\u003e\n\u003cli\u003eAncona MB, Beneduce A, Romano V, Buzzatti N, Russo F, Bellini B, et al. Self-expanding transcatheter aortic valve infolding: Current evidence, diagnosis, and management. Catheter Cardiovasc Interv. 2021;98(2):E299-e305.\u003c/li\u003e\n\u003cli\u003eKarrowni W, Fakih S, Nassar P. Infolding of Self-Expandable Transcatheter Heart Valve: Case Report and Review of Literature. Cureus. 2020;12(8):e10093.\u003c/li\u003e\n\u003cli\u003eSingh G, Le V, Wiechmann R, Schreiter S. Self-Expandable Transcatheter Aortic Valve Frame Infolding: An Increasingly Recognized Complication. European Journal of Case Reports in Internal Medicine. 2020;7(12).\u003c/li\u003e\n\u003cli\u003eSingh G, Le V, Wiechmann RJ, Schreiter SW. Self-Expandable Transcatheter Aortic Valve Frame Infolding: An Increasingly Recognized Complication. Eur J Case Rep Intern Med. 2020;7(12):002100.\u003c/li\u003e\n\u003cli\u003eVeulemans V, Piuhola J, Niemel\u0026auml; M, Maier O, Piayda K, Polzin A, et al. Incidence and Risk Assessment of Infolding Using Self-Expandable Devices in TAVR. Structural Heart. 2022;6(1).\u003c/li\u003e\n\u003cli\u003eShah R, Bolaji O, Bahar Y, Sah R, Ariaga AC, Paul TK, et al. Strategic Management of Valve Infolding in Evolut TAVR Procedures: Enhancing Outcomes and Ensuring Patient Safety. J Soc Cardiovasc Angiogr Interv. 2024;3(12):102394.\u003c/li\u003e\n\u003cli\u003eDurand E, Eltchaninoff H, Tchetche D, Levesque T, Garmendia C, Iung B, et al. Predictors of Outcomes of Reintervention After Transcatheter Aortic Valve Replacement: FRANCE 2 and FRANCE TAVI Registries. J Am Coll Cardiol. 2025;85(9):896-907.\u003c/li\u003e\n\u003cli\u003eMakkar RR, Thourani VH, Mack MJ, Kodali SK, Kapadia S, Webb JG, et al. Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement. New England Journal of Medicine. 2020;382(9):799-809.\u003c/li\u003e\n\u003cli\u003eTomii D, Okuno T, Heg D, Lanz J, Praz F, Stortecky S, et al. Validation of the VARC-3 Technical Success Definition in Patients Undergoing TAVR. JACC Cardiovasc Interv. 2022;15(4):353-64.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-cardiovascular-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bcar","sideBox":"Learn more about [BMC Cardiovascular Disorders](http://bmccardiovascdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bcar/default.aspx","title":"BMC Cardiovascular Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Vienna valve, TAVI, Self-expandable heart valve, Transcatheter aortic valve implantation, severe aortic stenosis","lastPublishedDoi":"10.21203/rs.3.rs-8854650/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8854650/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground:\u003c/h2\u003e \u003cp\u003eTranscatheter aortic valve implantation has become the preferred treatment for many patients with severe aortic stenosis. The Vienna valve is a next-generation, premounted self-expandable transcatheter heart valve designed to simplify procedural workflow and enhance deployment accuracy.\u003c/p\u003e\u003ch2\u003eObjective:\u003c/h2\u003e \u003cp\u003eTo evaluate the feasibility, procedural safety, and early clinical and hemodynamic outcomes of the Vienna transcatheter aortic valve system in patients with severe symptomatic aortic stenosis.\u003c/p\u003e\u003ch2\u003eMethod:\u003c/h2\u003e \u003cp\u003eThis prospective, dual-center observational study enrolled 13 consecutive patients with severe symptomatic aortic stenosis who underwent transfemoral TAVI using the Vienna valve between February 2024 and July 2025. Clinical and echocardiographic assessments were performed at baseline, post-procedure, and during follow-up at 1 and 6 months. Primary endpoints were mortality, stroke, bleeding, pacemaker requirement, rehospitalization, and functional improvement. Outcomes were defined according to Valve Academic Research Consortium-3 criteria.\u003c/p\u003e\u003ch2\u003eResult:\u003c/h2\u003e \u003cp\u003eThe mean patient age was 72\u0026thinsp;\u0026plusmn;\u0026thinsp;9 years, and the mean EuroSCORE II was 6.7\u0026thinsp;\u0026plusmn;\u0026thinsp;0.3%. Procedural success was achieved in 92.3% of cases. One intraprocedural cardiovascular death occurred due to valve infolding with cardiac tamponade. Mean transvalvular gradients decreased from 45.2\u0026thinsp;\u0026plusmn;\u0026thinsp;19.0 mmHg at baseline to 11.7\u0026thinsp;\u0026plusmn;\u0026thinsp;8.0 mmHg post-procedure and remained stable at 6 months. One patient (7.7%) required permanent pacemaker implantation during follow-up. No strokes, major bleeding events, or valve-related rehospitalizations were observed through 6 months.\u003c/p\u003e\u003ch2\u003eConclusion:\u003c/h2\u003e \u003cp\u003eIn this initial dual-center experience, the Vienna premounted self-expandable valve demonstrated encouraging feasibility, acceptable early safety, and sustained hemodynamic performance. Larger studies with longer follow-up are warranted to confirm long-term outcomes and durability.\u003c/p\u003e","manuscriptTitle":"First Dual-Center Clinical Experience With the Premounted Vienna Transcatheter Aortic Valve System: A Prospective Feasibility and Safety Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-03-22 15:01:40","doi":"10.21203/rs.3.rs-8854650/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2026-03-20T12:33:30+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"225345766951801216386770166981326742813","date":"2026-03-20T11:49:25+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-03-18T11:29:55+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2026-02-20T12:09:24+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-02-19T09:58:00+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-02-19T09:55:01+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Cardiovascular Disorders","date":"2026-02-11T17:43:34+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-cardiovascular-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bcar","sideBox":"Learn more about [BMC Cardiovascular Disorders](http://bmccardiovascdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bcar/default.aspx","title":"BMC Cardiovascular Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"87b795d4-630f-4abd-9c8f-e6d790efc425","owner":[],"postedDate":"March 22nd, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-03-22T15:01:40+00:00","versionOfRecord":[],"versionCreatedAt":"2026-03-22 15:01:40","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8854650","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8854650","identity":"rs-8854650","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}