BACKGROUND: The CONtrolled delivery For ImproveD outcomEs with cliNiCal Evidence registry was initiated to characterize the clinical safety and device performance from experienced transcatheter aortic valve implantation (TAVI) centers in Europe and Australia that use the Portico valve to treat patients with severe aortic stenosis. We herein report for the first time the valve performance at 30-day across all implanted valve sizes and the 1-year survival from this registry. METHODS: This was a prospective, multicenter, single-arm observational clinical investigation of patients clinically indicated for implantation of a Portico valve in experienced TAVI centers. Patients were treated with a commercially available valve (size 23, 25, 27, or 29 mm) using either the first-generation delivery system (DS) (n = 501) or the second-generation (FlexNav) DS (n = 500). Adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiographic outcomes were assessed at 30 days by an independent core laboratory, and a survival check was performed at 1 year. RESULTS: We enrolled 1001 patients (82.0 years, 62.5% female, 63.7% New York Heart Association functional class III/IV at baseline) from 27 clinical sites in 8 countries across Europe and one site in Australia. Implantation of a single valve was successful in 97.5% of subjects. Valve hemodynamics at 30 days were substantially improved relative to baseline, with large aortic valve areas and low mean gradients across all implanted valve sizes (aortic valve areas were 1.7 ± 0.4, 1.7 ± 0.5, 1.8 ± 0.5, and 2.0 ± 0.5 cm2, and mean gradients were 7.0 ± 2.7, 7.5 ± 4.7, 7.3 ± 3.3, and 6.4 ± 3.3 mmHg for 23, 25, 27, and 29 mm valve sizes, respectively). Across all implanted valve sizes, most patients (77.1%) had no patient-prosthesis mismatch. Death from any cause within 1 year occurred in 13.7% of the patients in the first-generation DS group as compared with 11.0% in the second-generation DS group (p = 0.2). CONCLUSIONS: The Portico valve demonstrated excellent hemodynamic performance across all valve sizes in a large cohort of subjects implanted in experienced TAVI centers. One-year survival rates were favorable when using both the first-generation and second-generation (FlexNav) DSs in this high-risk cohort. CLINICALTRIALSGOV IDENTIFIER: NCT03752866.

Abbott Laboratories Santa Clara California USA

Cardiology Department Puerta de Hierro Hospital Madrid Spain

Cardiovascular Institute Hospital Clinico San Carlos IdISSC Madrid Spain

Department of Cardiology Friedrich Alexander Universität Erlangen Nuremberg Erlangen Germany

Department of Cardiology Royal Victoria Hospital Belfast UK

Department of Cardiology St Johannes Hospital Dortmund Germany

Department of Cardiology University Hospital of the Johann Wolfgang Goethe University Frankfurt Frankfurt Germany

Department of Cardiovascular Surgery University Heart and Vascular Center Hamburg Germany

Department of Internal Medicine Cardiology University Hospital of the Technical University of Dresden Heart Center Dresden Dresden Germany

Department of Medicine Cardiology University Hospital Olomouc Olomouc Czech Republic

Interventional Cardiology Unit IRCCS San Raffaele Scientific Institute Milan Italy

IRCCS Policlinico San Donato Milan Italy

Kerckhoff Heart and Thorax Centre Bad Nauheim Germany

The Wesley Hospital Brisbane Australia

University of Queensland Brisbane Australia

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Makkar R.R., Fontana G.P., Jilaihawi H., et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012;366(18):1696–1704. doi: 10.1056/nejmoa1202277. PubMed DOI

Leon M.B., Smith C.R., Mack M.J., et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374(17):1609–1620. doi: 10.1056/nejmoa1514616. PubMed DOI

Mack M.J., Leon M.B., Thourani V.H., et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380(18):1695–1705. doi: 10.1056/nejmoa1814052. PubMed DOI

Möllmann H., Linke A., Holzhey D.M., et al. Implantation and 30-day follow-up on all 4 valve sizes within the Portico transcatheter aortic bioprosthetic family. JACC Cardiovasc Interv. 2017;10:1538–1547. PubMed

Makkar R.R., Cheng W., Waksman R., et al. 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. Lancet. 2020;396(10252):669–683. doi: 10.1016/S0140-6736(20)31358-1. Erratum in: Lancet. 2020 Sep 5;396(10252):668. PubMed DOI

Mollmann H., Linke A., Nombela-Franco L., et al. Procedural safety and device performance of the Portico™ valve from experienced TAVI centers: 30-day outcomes in the multicenter CONFIDENCE registry. J Clin Med. 2022;11(16):4839. doi: 10.3390/jcm11164839. PubMed DOI PMC

Wassef A.W.A., Rodes-Cabau J., Liu Y., et al. The learning curve and annual procedure volume standards for optimum outcomes of transcatheter aortic valve replacement: findings from an international registry. JACC Cardiovasc Interv. 2018;11(17):1669–1679. doi: 10.1016/j.jcin.2018.06.044. PubMed DOI

Schymik G., Lefèvre T., Bartorelli A.L., et al. European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis 1-year outcomes from the SOURCE XT registry. JACC Cardiovasc Interv. 2015;8:657–669. PubMed

Manoharan G., Van Mieghem N.M., Windecker S., et al. 1-Year outcomes with the Evolut R self-expanding transcatheter aortic valve: from the International FORWARD study. JACC Cardiovasc Interv. 2018;11(22):2326–2334. doi: 10.1016/j.jcin.2018.07.032. PubMed DOI

Kim W.K., Hengstenberg C., Hilker M., et al. The SAVI-TF registry: 1-year outcomes of the European post-market registry using the ACURATE neo transcatheter heart valve under real-world conditions in 1,000 patients. JACC Cardiovasc Interv. 2018;11(14):1368–1374. doi: 10.1016/j.jcin.2018.03.023. PubMed DOI

Blumenstein J., Eckel C., Husser O., et al. Multi-center comparison of two self-expanding transcatheter heart valves: a propensity matched analysis. J Clin Med. 2022;11(14):4228. doi: 10.3390/jcm11144228. PubMed DOI PMC

Voigtländer L., Kim W.K., Mauri V., et al. Transcatheter aortic valve implantation in patients with a small aortic annulus: performance of supra-, intra- and infra-annular transcatheter heart valves. Clin Res Cardiol. 2021;110(12):1957–1966. doi: 10.1007/s00392-021-01918-8. PubMed DOI PMC

Nakashima M., Watanabe Y. Transcatheter aortic valve implantation in small anatomy: patient selection and technical challenges. Interv Cardiol. 2018;13(2):66–68. doi: 10.15420/icr.2017:28:1. PubMed DOI PMC

Mauri V., Kim W.K., Abumayyaleh M., et al. Short-term outcome and hemodynamic performance of next-generation self-expanding versus balloon-expandable transcatheter aortic valves in patients with small aortic annulus: a multicenter propensity-matched comparison. Circ Cardiovasc Interv. 2017;10(10) doi: 10.1161/CIRCINTERVENTIONS.117.005013. PubMed DOI

Blumenstein J., Kim W.K., Liebetrau C., et al. Challenges of coronary angiography and intervention in patients previously treated by TAVI. Clin Res Cardiol. 2015;104(8):632–639. doi: 10.1007/s00392-015-0824-5. PubMed DOI

Barbanti M., Costa G., Picci A., et al. Coronary cannulation after transcatheter aortic valve replacement: the RE-ACCESS study. JACC Cardiovasc Interv. 2020;13(21):2542–2555. doi: 10.1016/j.jcin.2020.07.006. PubMed DOI

León Del Pino M.D.C., Ruíz Ortiz M., Delgado Ortega M., et al. Prosthesis-patient mismatch after transcatheter aortic valve replacement: prevalence and medium term prognostic impact. Int J Cardiovasc Imaging. 2019;35(5):827–836. doi: 10.1007/s10554-018-01519-z. PubMed DOI

Eckel C., Sötemann D., Kim W.-K., et al. Procedural outcomes of a self-expanding transcatheter heart valve in small annuli. J Clin Med. 2022;11(18):5313. doi: 10.3390/jcm11185313. PubMed DOI PMC

Fontana G.P., Bedogni F., Groh M., et al. Safety profile of an intra-annular self-expanding transcatheter aortic valve and next-generation low-profile delivery system. JACC Cardiovasc Interv. 2020;13(21):2467–2478. doi: 10.1016/j.jcin.2020.06.041. PubMed DOI

Corcione N., Morello A., Ferraro P., et al. The novel FlexNav delivery system for transcatheter aortic valve implantation with the Portico device: a case series. J Invasive Cardiol. 2021;33(6):E474–E478. PubMed

Costa G., Zappulla P., Barbanti M., et al. Pacemaker dependency after transcatheter aortic valve implantation: incidence, predictors and long-term outcomes. EuroIntervention. 2019;15(10):875–883. doi: 10.4244/EIJ-D-18-01060. PubMed DOI

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NCT03752866