Nikolaos Bonaros1, Rainer Petzina2, Riccardo Cocchieri3, Dariusz Jagielak4, Marco Aiello5, Joel Lapeze6, Mika Laine7, Sidney Chocron8, Douglas Muir9, Walter Eichinger10, Matthias Thielmann11, Louis Labrousse12, Vinayak Bapat13, Kjell Arne Rein14, Jean-Philippe Verhoye15, Gino Gerosa16, Hardy Baumbach17, Markus Kofler1, Peter Bramlage18, Cornelia Deutsch18, Martin Thoenes19, Derk Frank20, Mauro Romano21. 1. Department of Cardiac Surgery, Medical University Innsbruck, Innsbruck, Austria. 2. Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Kiel, Germany. 3. Heart Center, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands. 4. Department of Cardiac and Vascular Surgery, Medical University of Gdansk, Gdansk, Poland. 5. Department of Cardiothoracic Surgery, Foundation IRCCS Policlinico S.Matteo, Pavia, Italy. 6. Department of Cardivascular Surgery, Hospital Louis Pradel, Lyon, France. 7. Division of Cardiology, Helsinki University Central Hospital, Helsinki, Finland. 8. Cardiothoracic Surgery, Hospital Jean Minjoz, University Hospital of Besancon, Besancon, France. 9. Cardiothoracic Division, James Cook Hospital, Middlesbrough, UK. 10. Department of Cardiothoracic Surgery, Klinikum Bogenhausen, Munich, Germany. 11. Department of Thoracic and Cardiovascular Surgery, University Hospital Essen, Essen, Germany. 12. Department of Cardiovascular Surgery, CHU Hospital of Bordeaux, Bordeaux, France. 13. St. Thomas' Hospital, London, UK. 14. Department of Cardiothoracic Surgery, Rikshospital Oslo, Oslo, Norway. 15. Department of Cardiovascular Surgery, CHU Rennes, Rennes, France. 16. Department of Cardiac Surgery, University of Padova, Padova, Italy. 17. Department of Cardiovascular Surgery, Robert-Bosch-Krankenhaus Stuttgart, Stuttgart, Germany. 18. Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. 19. Edwards Lifesciences, Medical Affairs/Professional Education, Nyon, Switzerland. 20. Department of Internal Medicine III, UKSH, Campus Kiel, Germany. 21. Institut Hospitalier Jacques Cartier, Massy, France.
Abstract
OBJECTIVES: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed alternative to transapical (TA) or transfemoral (TF) TAVI. We aimed to analyse the effectiveness and safety of TAo-TAVI as a first line approach and to compare it to patients receiving TAo-TAVI as a last resort, which is current practice. METHODS: ROUTE is a prospective, multicentre registry to assess the clinical outcomes of TAo-TAVI. Patients without contraindications for TA- and TF-TAVI (TAo-first) were compared to patients with contraindications for both of these access routes (TAo-last). Outcome analysis was based on VARC II defined clinical end-points. RESULTS: Three hundred and one patients were included, of which 224 patients met TAo-first and 77 TAo-last criteria. The valve was delivered and catheter retrieved successfully in all patients. In the TAo-first group, rates of conversion to open surgery and requirement for a second valve were low and not different compared to TAo-last patients (1% vs. 3%, P = 0.46 and 1% vs. 3%, P = 0.46, respectively). This was also true for the rate of paravalvular regurgitation (≥ moderate: 4% vs. 3%). All-cause mortality at 30-days was 6% vs. 5% ( P = 0.76), rates of stroke 2% vs. 0% ( P = 0.24), pacemaker implantation (11% vs. 4%, P = 0.093), and life-threatening bleeding 4% vs. 3% ( P = 0.70). Valve safety (both 85%, P = 0.98) and clinical efficacy (80% vs. 82%; P = 0.73) did not differ between groups. CONCLUSIONS: Although comparative data to TA and TF procedures were not available in the present analysis, findings suggest that TAo may be considered not only as a last resort strategy when classical access routes are deemed unfeasible, but also as a potential first-line option, with only low rates of paravalvular regurgitation and permanent pacemaker implantation. CLINICALTRIALS.GOV: NCT01991431.
OBJECTIVES: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed alternative to transapical (TA) or transfemoral (TF) TAVI. We aimed to analyse the effectiveness and safety of TAo-TAVI as a first line approach and to compare it to patients receiving TAo-TAVI as a last resort, which is current practice. METHODS: ROUTE is a prospective, multicentre registry to assess the clinical outcomes of TAo-TAVI. Patients without contraindications for TA- and TF-TAVI (TAo-first) were compared to patients with contraindications for both of these access routes (TAo-last). Outcome analysis was based on VARC II defined clinical end-points. RESULTS: Three hundred and one patients were included, of which 224 patients met TAo-first and 77 TAo-last criteria. The valve was delivered and catheter retrieved successfully in all patients. In the TAo-first group, rates of conversion to open surgery and requirement for a second valve were low and not different compared to TAo-last patients (1% vs. 3%, P = 0.46 and 1% vs. 3%, P = 0.46, respectively). This was also true for the rate of paravalvular regurgitation (≥ moderate: 4% vs. 3%). All-cause mortality at 30-days was 6% vs. 5% ( P = 0.76), rates of stroke 2% vs. 0% ( P = 0.24), pacemaker implantation (11% vs. 4%, P = 0.093), and life-threatening bleeding 4% vs. 3% ( P = 0.70). Valve safety (both 85%, P = 0.98) and clinical efficacy (80% vs. 82%; P = 0.73) did not differ between groups. CONCLUSIONS: Although comparative data to TA and TF procedures were not available in the present analysis, findings suggest that TAo may be considered not only as a last resort strategy when classical access routes are deemed unfeasible, but also as a potential first-line option, with only low rates of paravalvular regurgitation and permanent pacemaker implantation. CLINICALTRIALS.GOV: NCT01991431.
Authors: Aleksandra Stańska; Dariusz Jagielak; Maciej Kowalik; Maciej Brzeziński; Rafał Pawlaczyk; Jadwiga Fijałkowska; Wojciech Karolak; Jan Rogowski; Peter Bramlage Journal: J Geriatr Cardiol Date: 2018-11 Impact factor: 3.327
Authors: Derk Frank; Simon Kennon; Nikolaos Bonaros; Mauro Romano; Thierry Lefèvre; Carlo Di Mario; Pierluigi Stefàno; Flavio Luciano Ribichini; Dominique Himbert; Marina Urena-Alcazar; Jorge Salgado-Fernandez; Jose Joaquin Cuenca Castillo; Bruno Garcia; Jana Kurucova; Martin Thoenes; Claudia Lüske; Peter Bramlage; Rima Styra Journal: Open Heart Date: 2019-05-21
Authors: Lukas Stastny; Christoph Krapf; Julia Dumfarth; Simone Gasser; Axel Bauer; Guy Friedrich; Bernhard Metzler; Gudrun Feuchtner; Agnes Mayr; Michael Grimm; Nikolaos Bonaros Journal: Front Cardiovasc Med Date: 2022-03-04