{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T22:38:36Z","timestamp":1791844716933,"version":"4.3.4"},"reference-count":29,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2023,6,12]],"date-time":"2023-06-12T00:00:00Z","timestamp":1686528000000},"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: Third-generation transcatheter heart valves (THVs) are designed to improve outcomes. Data on the new intra-annular self-expanding NAVITOR are scarce. Aims: The aim of this analysis was to compare outcomes between the PORTICO and the NAVITOR systems. Methods: Data from 782 patients with severe native aortic stenosis treated with PORTICO (n = 645) or NAVITOR (n = 137) from 05\/2012 to 09\/2022 were evaluated. The clinical and hemodynamic outcomes of 276 patients (PORTICO, n = 139; NAVITOR, n = 137) were evaluated according to VARC-3 recommendations. Results: Rates of postprocedural more-than-mild paravalvular leakage (PVL) were significantly lower for NAVITOR than for PORTICO (7.2% vs. 1.5%, p = 0.041). In addition, severe bleeding rates (27.3% vs. 13.1%, p = 0.005) and major vascular complications (5.8% vs. 0.7%, p = 0.036) were lower in the NAVITOR group. The mean gradients (7 vs. 8 mmHg, p = 0.121) and calculated aortic valve areas (1.90 cm2 vs. 1.99 cm2, p = 0.235) were comparable. Rates of PPI were similarly high in both groups (15.3 vs. 21.6, p = 0.299). Conclusions: The NAVITOR demonstrated favorable in-hospital procedural outcome data, with lower rates of relevant PVL, major vascular complications, and severe bleeding than its predecessor the PORTICO and preserved favorable hemodynamic outcomes.<\/jats:p>","DOI":"10.3390\/jcm12123999","type":"journal-article","created":{"date-parts":[[2023,6,13]],"date-time":"2023-06-13T02:00:45Z","timestamp":1686621645000},"page":"3999","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Comparison of the New-Generation Self-Expanding NAVITOR Transcatheter Heart Valve with Its Predecessor, the PORTICO, in Severe Native Aortic Valve Stenosis"],"prefix":"10.3390","volume":"12","author":[{"given":"Clemens Enno","family":"Eckel","sequence":"first","affiliation":[{"name":"Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany"},{"name":"Department of Cardiology, University of Oldenburg, 26129 Oldenburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Won-Keun","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, Kerckhoff Heart Center, 61231 Bad Nauheim, Germany"},{"name":"Department of Cardiology, Kerckhoff Heart Center, 61231 Bad Nauheim, 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 Vascular Surgery, University of Kiel, 24098 Kiel, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vedat","family":"Tiyerili","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":"Department of Cardiology, University of 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":"Judith","family":"Schl\u00fcter","sequence":"additional","affiliation":[{"name":"Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany"},{"name":"Department of Cardiology, University of Oldenburg, 26129 Oldenburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5796-9926","authenticated-orcid":false,"given":"Yeong-Hoon","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, Kerckhoff Heart Center, 61231 Bad Nauheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0284-8200","authenticated-orcid":false,"given":"Efstratios I.","family":"Charitos","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, Kerckhoff Heart Center, 61231 Bad Nauheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4756-5397","authenticated-orcid":false,"given":"Matthias","family":"Renker","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Kerckhoff Heart Center, 61231 Bad Nauheim, Germany"},{"name":"German Center for Cardiovascular Research (DZHK), Partner Site Rhine-Main, 55131 Bad Nauheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian W.","family":"Hamm","sequence":"additional","affiliation":[{"name":"German Center for Cardiovascular Research (DZHK), Partner Site Rhine-Main, 55131 Bad Nauheim, Germany"},{"name":"Department of Cardiology, University of Giessen, 35390 Giessen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6577-7898","authenticated-orcid":false,"given":"Guido","family":"Dohmen","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, St. Johannes Hospital, 44137 Dortmund, 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":"Johannes","family":"Blumenstein","sequence":"additional","affiliation":[{"name":"Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany"},{"name":"Department of Cardiology, University of Oldenburg, 26129 Oldenburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,6,12]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"669","DOI":"10.1016\/S0140-6736(20)31358-1","article-title":"Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): A randomised, controlled, non-inferiority trial","volume":"396","author":"Makkar","year":"2020","journal-title":"Lancet"},{"key":"ref_2","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_3","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_4","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_5","first-page":"1387","article-title":"Determinants of paravalvular leakage following transcatheter aortic valve replacement in patients with bicuspid and tricuspid aortic stenosis","volume":"22","author":"Kim","year":"2021","journal-title":"Eur. Heart J. Cardiovasc. Imaging"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"581","DOI":"10.1016\/j.jacc.2012.02.045","article-title":"Transcatheter aortic valve replacement with the St. Jude Medical Portico valve: First-in-human experience","volume":"60","author":"Willson","year":"2012","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_7","unstructured":"Smith, D. (2023, March 04). One-Year Clinical Trial Results with A Next-Generation Aortic Transcatheter Heart Valve. Pcronline. Available online: https:\/\/media.pcronline.com\/diapos\/EuroPCR2022\/2618-20220517_1600_Room_Maillot_Smith_Dave_1111111_(5728)\/Smith_Dave_20220517_1530_Room_Maillot.pdf."},{"key":"ref_8","doi-asserted-by":"crossref","unstructured":"Varc-3 Writing, C., Genereux, P., Piazza, N., Alu, M.C., Nazif, T., Hahn, R.T., Pibarot, P., Bax, J.J., Leipsic, J.A., and Blanke, P. (2021). Valve Academic Research Consortium 3, Updated Endpoint Definitions for Aortic Valve Clinical Research. J. Am. Coll. Cardiol., 77, 2717\u20132746.","DOI":"10.1016\/j.jacc.2021.02.038"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"924","DOI":"10.1007\/s00392-022-02006-1","article-title":"Transcatheter-based aortic valve replacement vs. isolated surgical aortic valve replacement in 2020","volume":"111","author":"Gaede","year":"2022","journal-title":"Clin. Res. Cardiol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1016\/j.ijcard.2021.12.044","article-title":"Anatomical suitability and off-label use of contemporary transcatheter heart valves","volume":"350","author":"Werner","year":"2022","journal-title":"Int. J. Cardiol."},{"key":"ref_11","first-page":"197","article-title":"Surgical or Transcatheter Aortic-Valve Replacement","volume":"377","author":"Reardon","year":"2017","journal-title":"N. Engl. J. Med."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"1609","DOI":"10.1056\/NEJMoa1514616","article-title":"Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients","volume":"374","author":"Leon","year":"2016","journal-title":"N. Engl. J. Med."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1244","DOI":"10.1016\/j.amjcard.2016.07.045","article-title":"Frequency and Effect of Access-Related Vascular Injury and Subsequent Vascular Intervention After Transcatheter Aortic Valve Replacement","volume":"118","author":"Dencker","year":"2016","journal-title":"Am. J. Cardiol."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1053","DOI":"10.4244\/EIJ-D-20-01293","article-title":"Paravalvular regurgitation after transcatheter aortic valve replacement in intermediate-risk patients: A pooled PARTNER 2 study","volume":"17","author":"Chau","year":"2022","journal-title":"EuroIntervention"},{"key":"ref_15","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 Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry. J. Clin. Med., 11.","DOI":"10.3390\/jcm11164839"},{"key":"ref_16","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."},{"key":"ref_17","doi-asserted-by":"crossref","unstructured":"Blumenstein, J., Eckel, C., Husser, O., Kim, W.K., Renker, M., Choi, Y.H., Hamm, C.W., Al-Terki, H., Sotemann, D., and Korbi, L. (2022). Multi-Center Comparison of Two Self-Expanding Transcatheter Heart Valves: A Propensity Matched Analysis. J. Clin. Med., 11.","DOI":"10.3390\/jcm11144228"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1912","DOI":"10.1007\/s00392-021-01882-3","article-title":"The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes","volume":"110","author":"Mollmann","year":"2021","journal-title":"Clin. Res. Cardiol."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"E442","DOI":"10.25270\/jic\/21.00264","article-title":"Comparison of Catheterization Versus Echocardiographic-Based Gradients in Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Implantation","volume":"34","author":"Biersmith","year":"2022","journal-title":"J. Invasive Cardiol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"160","DOI":"10.1016\/j.jcin.2017.10.014","article-title":"Early Outcomes with the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve with Pericardial Wrap","volume":"11","author":"Forrest","year":"2018","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_21","doi-asserted-by":"crossref","unstructured":"Eckel, C., Sotemann, 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_22","doi-asserted-by":"crossref","first-page":"449","DOI":"10.1093\/eurheartj\/ehu384","article-title":"Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: Characterizing patients and impact on outcomes","volume":"36","author":"Kodali","year":"2015","journal-title":"Eur. Heart J."},{"key":"ref_23","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_24","doi-asserted-by":"crossref","first-page":"244","DOI":"10.1016\/j.jcin.2015.09.036","article-title":"Predictors of Permanent Pacemaker Implantations and New-Onset Conduction Abnormalities with the SAPIEN 3 Balloon-Expandable Transcatheter Heart Valve","volume":"9","author":"Husser","year":"2016","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_25","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_26","doi-asserted-by":"crossref","first-page":"1582","DOI":"10.1016\/j.jcin.2022.04.014","article-title":"Neo-Commissural Alignment During Transcatheter Aortic Valve Replacement: The LACRCO Algorithm","volume":"15","author":"Wong","year":"2022","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"1269","DOI":"10.1016\/j.jcin.2021.03.059","article-title":"A Novel Method of Assessing Commissural Alignment for the SAPIEN 3 Transcatheter Aortic Valve","volume":"14","author":"Spilias","year":"2021","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"147","DOI":"10.4244\/EIJV14I2A24","article-title":"Transcatheter aortic valve implantation: Don\u2019t forget the coronary arteries!","volume":"14","author":"Sondergaard","year":"2018","journal-title":"EuroIntervention"},{"key":"ref_29","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."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/12\/3999\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T19:53:12Z","timestamp":1760125992000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/12\/3999"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,12]]},"references-count":29,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2023,6]]}},"alternative-id":["jcm12123999"],"URL":"https:\/\/doi.org\/10.3390\/jcm12123999","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,6,12]]}}}