{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T22:38:37Z","timestamp":1791844717855,"version":"4.3.4"},"reference-count":26,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2025,3,8]],"date-time":"2025-03-08T00:00:00Z","timestamp":1741392000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Prosthesis-patient mismatch (PPM) has been demonstrated to affect the outcome of both surgical (SAVR) and transcatheter aortic valve replacement (TAVR) patients. Supra-annular transcatheter valves (SAV) appear to offer a superior solution to intra-annular valves (IAV) in this regard. However, data on the comparison of the intra-annular self-expanding (SE) NAVITOR and the intra-annular balloon-expandable (BE) Sapien 3 Ultra in small annuli are limited. Methods: A total of 179 patients with severe native aortic valve stenosis were treated with either the SE NAVITOR (SEV; n = 104) or the BE Sapien 3 Ultra (BEV; n = 75) between March 2019 and June 2024. We compared the clinical and hemodynamic outcomes of the cohort according to the implanted prostheses. BMI-adjusted PPM was defined in accordance with the VARC-3 recommendations. Results: The device success at 30 days was superior in patients treated with the NAVITOR prosthesis (94.2% vs. 80.0%, p &lt; 0.001), mainly driven by a higher rate of elevated gradients in the BEV group. The post-procedural mean gradient (8.0 mmHg vs. 13.0 mmHg, p &lt; 0.001) as well as the rate of moderate to severe prosthesis patient mismatch (12.2% vs. 33.3%, p = 0.002) was higher in BEV recipients while the rate of more than moderate paravalvular leakage (PVL) or Valve in Valve (VinV) due to PVL (1.0% vs. 1.3%, p = 1.000) was similar between both groups. Pacemaker implantations were numerically more common after SEV (18.4% vs. 8.5%, p = 0.110). There was a trend towards higher thirty-day all-cause mortality among patients treated with SAV (3.8% vs. 1.3%, p = 0.401). Conclusion: The NAVITOR system may offer a more favorable hemodynamic profile compared to the Sapien 3 Ultra device in patients with small aortic annuli.<\/jats:p>","DOI":"10.3390\/jcm14061824","type":"journal-article","created":{"date-parts":[[2025,3,10]],"date-time":"2025-03-10T05:46:52Z","timestamp":1741585612000},"page":"1824","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Does Intra-Annular Valve Design Equal Intra-Annular Valve Design? Comparison of Two Transcatheter Aortic Valve Prostheses"],"prefix":"10.3390","volume":"14","author":[{"given":"Clemens","family":"Eckel","sequence":"first","affiliation":[{"name":"Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany"},{"name":"School IV, Carl von Ossietzky Universit\u00e4t Oldenburg, 26129 Oldenburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fadi","family":"Al-Rashid","sequence":"additional","affiliation":[{"name":"Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany"},{"name":"Department of Cardiology, University Hospital Essen, 45147 Duisburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Bargon","sequence":"additional","affiliation":[{"name":"Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Schl\u00fcter","sequence":"additional","affiliation":[{"name":"Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany"},{"name":"School IV, Carl von Ossietzky Universit\u00e4t Oldenburg, 26129 Oldenburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dagmar","family":"S\u00f6temann","sequence":"additional","affiliation":[{"name":"Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Albrecht","family":"Els\u00e4sser","sequence":"additional","affiliation":[{"name":"School IV, Carl von Ossietzky Universit\u00e4t Oldenburg, 26129 Oldenburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johannes","family":"Blumenstein","sequence":"additional","affiliation":[{"name":"Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany"},{"name":"School IV, Carl von Ossietzky Universit\u00e4t Oldenburg, 26129 Oldenburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helge","family":"M\u00f6llmann","sequence":"additional","affiliation":[{"name":"Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Grothusen","sequence":"additional","affiliation":[{"name":"Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany"},{"name":"Department of Cardiac and Thoracic Vascular Surgery, University Hospital of Schleswig-Holstein, 24105 Kiel, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,3,8]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1218","DOI":"10.1016\/j.jcin.2021.03.060","article-title":"Predictors and Clinical Impact of Prosthesis-Patient Mismatch After Self-Expandable TAVR in Small Annuli","volume":"14","author":"Leone","year":"2021","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Eckel, C., S\u00f6temann, D., Kim, W.-K., Grothusen, C., Tiyerili, V., Dohmen, G., Renker, M., Charitos, E., Hamm, C.W., and Choi, Y.-H. (2022). Procedural Outcomes of a Self-Expanding Transcatheter Heart Valve in Small Annuli. J. Clin. Med., 11.","DOI":"10.3390\/jcm11185313"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"86","DOI":"10.1536\/ihj.17-656","article-title":"Valve Hemodynamics and Clinical Outcomes After Transcatheter Aortic Valve Replacement for a Small Aortic Annulus","volume":"60","author":"Kamioka","year":"2019","journal-title":"Int. Heart J."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"1959","DOI":"10.1056\/NEJMoa2312573","article-title":"Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus","volume":"390","author":"Herrmann","year":"2024","journal-title":"N. Engl. J. Med."},{"key":"ref_5","doi-asserted-by":"crossref","unstructured":"Eckel, C.E., Kim, W.-K., Grothusen, C., Tiyerili, V., Els\u00e4sser, A., S\u00f6temann, D., Schl\u00fcter, J., Choi, Y.-H., Charitos, E.I., and Renker, M. (2023). Comparison of the New-Generation Self-Expanding NAVITOR Transcatheter Heart Valve with Its Predecessor, the PORTICO, in Severe Native Aortic Valve Stenosis. J. Clin. Med., 12.","DOI":"10.3390\/jcm12123999"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"366","DOI":"10.1016\/j.jcct.2012.11.002","article-title":"SCCT expert consensus document on computed tomography imaging before transcatheter aortic valve implantation (TAVI)\/transcatheter aortic valve replacement (TAVR)","volume":"6","author":"Achenbach","year":"2012","journal-title":"J. Cardiovasc. Comput. Tomogr."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"827","DOI":"10.1016\/0735-1097(90)90282-T","article-title":"Quantification of coronary artery calcium using ultrafast computed tomography","volume":"15","author":"Agatston","year":"1990","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"995","DOI":"10.1007\/s00392-017-1149-3","article-title":"Comparison of outcomes using balloon-expandable versus self-expanding transcatheter prostheses according to the extent of aortic valve calcification","volume":"106","author":"Kim","year":"2017","journal-title":"Clin. Res. Cardiol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"2717","DOI":"10.1016\/j.jacc.2021.02.038","article-title":"Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research","volume":"77","author":"Piazza","year":"2021","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"961","DOI":"10.21037\/atm.2020.04.13","article-title":"Choice of transcatheter heart valve: Should we select the device according to each patient\u2019s characteristics or should it be \u201cone valve fits all\u201d?","volume":"8","author":"Renker","year":"2020","journal-title":"Ann. Transl. Med."},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Mollmann, H., Linke, A., Nombela-Franco, L., Sluka, M., Dominguez, J.F.O., Montorfano, M., Kim, W.-K., Arnold, M., Vasa-Nicotera, M., and Conradi, L. (2022). Procedural Safety and Device Performance of the Portico\u2122 Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry. J. Clin. Med., 11.","DOI":"10.3390\/jcm11164839"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"1538","DOI":"10.1016\/j.jcin.2017.05.021","article-title":"Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family","volume":"10","author":"Linke","year":"2017","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"e010543","DOI":"10.1161\/CIRCINTERVENTIONS.121.010543","article-title":"Real-World Experience with the SAPIEN 3 Ultra Transcatheter Heart Valve: A Propensity-Matched Analysis from the United States","volume":"14","author":"Nazif","year":"2021","journal-title":"Circ. Cardiovasc. Interv."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"353","DOI":"10.2147\/MDER.S143897","article-title":"Spotlight on the SAPIEN 3 transcatheter heart valve","volume":"11","author":"Rheude","year":"2018","journal-title":"Med. Devices Evid. Res."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"e005013","DOI":"10.1161\/CIRCINTERVENTIONS.117.005013","article-title":"Short-Term Outcome and Hemodynamic Performance of Next-Generation Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valves in Patients with Small Aortic Annulus","volume":"10","author":"Mauri","year":"2017","journal-title":"Circ. Cardiovasc. Interv."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1323","DOI":"10.1016\/j.jacc.2014.06.1195","article-title":"Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: A PARTNER trial cohort\u2014A analysis","volume":"64","author":"Pibarot","year":"2014","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"1071","DOI":"10.1016\/j.jcin.2019.12.026","article-title":"5-Year Outcomes After TAVR with Balloon-Expandable Versus Self-Expanding Valves","volume":"13","author":"Landt","year":"2020","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"579","DOI":"10.4244\/EIJ-D-23-00996","article-title":"Performance and outcomes of the SAPIEN 3 Ultra RESILIA transcatheter heart valve in the OCEAN-TAVI registry","volume":"20","author":"Yamamoto","year":"2024","journal-title":"EuroIntervention"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"467","DOI":"10.1093\/ejcts\/ezy078","article-title":"Incidence of new-onset left bundle branch block and predictors of new permanent pacemaker following transcatheter aortic valve replacement with the Portico\u2122 valve","volume":"54","author":"Walther","year":"2018","journal-title":"Eur. J. Cardio Thorac. Surg."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"3081","DOI":"10.1007\/s10554-021-02275-3","article-title":"Implantation depth and its influence on complications after TAVI with self-expanding valves","volume":"37","author":"Breitbart","year":"2021","journal-title":"Int. J. Cardiovasc. Imaging"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"1712","DOI":"10.1016\/j.amjcard.2018.07.046","article-title":"Impact of Right Ventricular Pacing in Patients Who Underwent Implantation of Permanent Pacemaker After Transcatheter Aortic Valve Implantation","volume":"122","author":"Nadeem","year":"2018","journal-title":"Am. J. Cardiol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"1127","DOI":"10.1093\/europace\/euac008","article-title":"Long-term clinical impact of permanent pacemaker implantation in patients undergoing transcatheter aortic valve implantation: A systematic review and meta-analysis","volume":"24","author":"Zito","year":"2022","journal-title":"Europace"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"e011045","DOI":"10.1161\/CIRCINTERVENTIONS.121.011045","article-title":"Coronary Access After Transcatheter Aortic Valve Replacement with Commissural Alignment: The ALIGN-ACCESS Study","volume":"15","author":"Tarantini","year":"2022","journal-title":"Circ. Cardiovasc. Interv."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"1590","DOI":"10.1016\/j.jcin.2022.06.010","article-title":"Neo-Commissural Alignment and Coronary Artery Overlap Following Portico Aortic Valve Implantation","volume":"15","author":"Gheorghe","year":"2022","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"E474","DOI":"10.25270\/jic\/20.00513","article-title":"The Novel FlexNav Delivery System for Transcatheter Aortic Valve Implantation with the Portico Device: A Case Series","volume":"33","author":"Corcione","year":"2021","journal-title":"J. Invasive Cardiol."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"2467","DOI":"10.1016\/j.jcin.2020.06.041","article-title":"Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System","volume":"13","author":"Fontana","year":"2020","journal-title":"JACC Cardiovasc. Interv."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/6\/1824\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T16:49:23Z","timestamp":1760028563000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/6\/1824"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,8]]},"references-count":26,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2025,3]]}},"alternative-id":["jcm14061824"],"URL":"https:\/\/doi.org\/10.3390\/jcm14061824","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,8]]}}}