Advertisement
Heart, Lung and Circulation
Original Article| Volume 32, ISSUE 2, P224-231, February 2023

30-Day Outcomes With the Portico Transcatheter Heart Valve: Insights From a Multi-Centre Australian Observational Study

Published:November 04, 2022DOI:https://doi.org/10.1016/j.hlc.2022.09.012

      Background

      Transcatheter aortic valve implantation (TAVI) is an established therapy for the treatment of aortic valve disease in appropriately selected patients. Previous studies using the self-expanding Portico transcatheter heart valve (THV), (Abbott Structural Heart, St Paul, MN, USA) have demonstrated the technical feasibility of this system albeit in the hands of relatively inexperienced Portico users. The objective of this study was to assess the real-world safety and efficacy of the Portico THV (with and without the FlexNav delivery system, Abbott Structural Heart) at the 30-day timepoint in an Australian cohort.

      Methods and Results

      This study was a retrospective real-world cohort analysis of 269 consecutive patients with severe aortic valve disease who underwent TAVI at multiple centres within Australia between February 2015 and April 2021. Of the 269 patients, 51.7% were female, mean Society of Thoracic Surgeons (STS) score was 5.2 (±6.8) and 98.5% had successful implantations. Thirty (30)-day post-implantation all-cause mortality was observed in one (0.4%) patient, major vascular complications in two (0.7%) patients, more-than-mild paravalvular leak in six (2.2%) patients and requirement for new permanent pacemaker implantation in 27 (10.2%) patients. Haemodynamic parameters at 30 days included mean effective orifice area (EOA) of 2.3 (±0.9) cm2 and mean aortic valve gradient (AVG) of 9.6 (±6.2) mmHg.

      Conclusion

      This analysis of the Portico THV in a real-world setting suggested that the system is associated with satisfactory safety and efficacy parameters. Previously published datasets may not have found similar findings owing to lower operator experience with the Portico THV system.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Heart, Lung and Circulation
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Spears J.
        • Al-Saiegh Y.
        • Goldberg D.
        • Manthey S.
        • Goldberg S.
        TAVR: a review of current practices and considerations in low-risk patients.
        J Interv Cardiol. 2020; 20202582938
        • Webb J.G.
        • Wood D.A.
        Current status of transcatheter aortic valve replacement.
        J Am Coll Cardiol. 2012; 60: 483-492
        • Mack M.J.
        • Brennan J.M.
        • Brindis R.
        • Carroll J.
        • Edwards F.
        • Grover F.
        • et al.
        Outcomes following transcatheter aortic valve replacement in the United States.
        JAMA. 2013; 310: 2069-2077
        • Maisano F.
        • Worthley S.
        • Rodes-Cabau J.
        • Linke A.H.
        • Fichtlscherer S.
        • Schafer U.
        • et al.
        Early commercial experience from transcatheter aortic valve implantation using the Portico bioprosthetic valve: 30-day outcomes in the multicentre PORTICO-1 study.
        EuroIntervention. 2018; 14: 886-893
        • Khokhar A.A.
        • Ruggiero R.
        • Chandra K.
        • D’Agostino A.
        • Toselli M.
        • Mangieri A.
        • et al.
        Prevention and management of peri-procedural TAVR complications.
        Mini-invasive Surgery. 2022; 6: 2
        • Thourani V.H.
        • Kodali S.
        • Makkar R.R.
        • Herrmann H.C.
        • Williams M.
        • Babaliaros V.
        • et al.
        Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis.
        Lancet. 2016; 387: 2218-2225
        • Smith C.R.
        • Leon M.B.
        • Mack M.J.
        • Miller D.C.
        • Moses J.W.
        • Svensson L.G.
        • et al.
        Transcatheter versus surgical aortic-valve replacement in high-risk patients.
        N Engl J Med. 2011; 364: 2187-2198
        • Kodali S.K.
        • Williams M.R.
        • Smith C.R.
        • Svensson L.G.
        • Webb J.G.
        • Makkar R.R.
        • et al.
        Two-year outcomes after transcatheter or surgical aortic-valve replacement.
        N Engl J Med. 2012; 366: 1686-1695
        • Ueshima D.
        • Fovino L.N.
        • D’Amico G.
        • Brener S.J.
        • Esposito G.
        • Tarantini G.
        Transcatheter versus surgical aortic valve replacement in low- and intermediate-risk patients: an updated systematic review and meta-analysis.
        Cardiovasc Interv Ther. 2019; 34: 216-225
        • Leon M.B.
        • Smith C.R.
        • Mack M.J.
        • Makkar R.R.
        • Svensson L.G.
        • Kodali S.K.
        • et al.
        Transcatheter or surgical aortic-valve replacement in intermediate-risk patients.
        N Engl J Med. 2016; 374: 1609-1620
        • Otto C.M.
        • Nishimura R.A.
        • Bonow R.O.
        • Carabello B.A.
        • Erwin 3rd, J.P.
        • 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: e72-e227
        • Otto C.M.
        • Nishimura R.A.
        • Bonow R.O.
        • Carabello B.A.
        • Erwin 3rd, J.P.
        • Gentile F.
        • et al.
        2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.
        Circulation. 2021; 143: e35-e71
        • Vahanian 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: 561-632
        • Manoharan G.
        • Spence M.S.
        • Rodes-Cabau J.
        • Webb J.G.
        St Jude Medical Portico valve.
        EuroIntervention. 2012; 8: Q97-Q101
        • Willson A.B.
        • Rodes-Cabau J.
        • Wood D.A.
        • Leipsic J.
        • Cheung A.
        • Toggweiler S.
        • et al.
        Transcatheter aortic valve replacement with the St. Jude Medical Portico valve: first-in-human experience.
        J Am Coll Cardiol. 2012; 60: 581-586
        • Mollmann H.
        • Linke A.
        • Holzhey D.M.
        • Walther T.
        • Manoharan G.
        • Schafer U.
        • 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
        • Taramasso M.
        • Denegri A.
        • Kuwata S.
        • Rickli H.
        • Haager P.K.
        • Sütsch G.
        • et al.
        Feasibility and safety of transfemoral sheathless portico aortic valve implantation: Preliminary results in a single center experience.
        Catheter Cardiovasc Interv. 2018; 91: 533-539
        • Linke A.
        • Holzhey D.
        • Möllmann H.
        • Manoharan G.
        • Schäfer U.
        • Frerker C.
        • et al.
        Treatment of aortic stenosis with a self-expanding, resheathable transcatheter valve: one-year results of the international multicenter Portico transcatheter aortic valve implantation system study.
        Circ Cardiovasc Interv. 2018; 11e005206
        • Santos-Martinez S.
        • Halim J.
        • Castro-Mejía A.
        • De Marco F.
        • Trani C.
        • Martin P.
        • et al.
        Myval versus alternative balloon- and self-expandable transcatheter heart valves: a central core lab analysis of conduction disturbances.
        Int J Cardiol. 2022;
        • Möllmann H.
        • Linke A.
        • Holzhey D.M.
        • Walther T.
        • Manoharan G.
        • Schäfer U.
        • 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
        • Makkar R.R.
        • Cheng W.
        • Waksman R.
        • Satler L.F.
        • Chakravarty T.
        • Groh M.
        • 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: 669-683
        • Walters D.L.
        • Webster M.
        • Pasupati S.
        • Walton A.
        • Muller D.
        • Stewart J.
        • et al.
        Position statement for the operator and institutional requirements for a transcatheter aortic valve implantation (TAVI) program.
        Heart Lung Circ. 2015; 24: 219-223
      1. MBS listing for transcatheter aortic valve implantation (TAVI).
        in: Health Australian Government Department of Health and Aged Care. Medicare Benefits Schedule, 2017
        • Kappetein A.P.
        • Head S.J.
        • Genereux P.
        • Piazza N.
        • van Mieghem N.M.
        • Blackstone E.H.
        • et al.
        Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.
        J Thorac Cardiovasc Surg. 2013; 145: 6-23
        • Kappetein A.P.
        • Head S.J.
        • Genereux P.
        • Piazza N.
        • van Mieghem N.M.
        • Blackstone E.H.
        • et al.
        Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.
        J Am Coll Cardiol. 2012; 60: 1438-1454
        • Fontana G.P.
        • Bedogni F.
        • Groh M.
        • Smith D.
        • Chehab B.M.
        • Garrett Jr., H.E.
        • 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: 2467-2478
        • Takagi H.
        • Umemoto T.
        Impact of paravalvular aortic regurgitation after transcatheter aortic valve implantation on survival.
        Int J Cardiol. 2016; 221: 46-51
        • Kodali S.
        • Pibarot P.
        • Douglas P.S.
        • Williams M.
        • Xu K.
        • Thourani V.
        • et al.
        Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards Sapien valve in the PARTNER trial: characterizing patients and impact on outcomes.
        Eur Heart J. 2014; 36: 449-456
        • Mack M.J.
        • Leon M.B.
        • Smith C.R.
        • Miller D.C.
        • Moses J.W.
        • Tuzcu E.M.
        • et al.
        5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial.
        Lancet. 2015; 385: 2477-2484
        • Belle E.V.
        • Juthier F.
        • Susen S.
        • Vincentelli A.
        • Iung B.
        • Dallongeville J.
        • et al.
        Postprocedural aortic regurgitation in balloon-expandable and self-expandable transcatheter aortic valve replacement procedures.
        Circulation. 2014; 129: 1415-1427
        • Schoechlin S.
        • Hein M.
        • Brennemann T.
        • Eichenlaub M.
        • Schulz U.
        • Jander N.
        • et al.
        5-Year outcomes after transcatheter aortic valve implantation: focus on paravalvular leakage assessed by echocardiography and hemodynamic parameters.
        Catheter Cardiovasc Interv. 2022; 99: 1582-1589
        • Manual I.
        Portico™ Transcatheter Aortic Valve Implantation System.
        In: Abbott, editor, 2020
        • Grygier M.
        • Olasińska-Wiśniewska A.
        • Misterski M.
        • Perek B.
        • Urbanowicz T.
        • Markiewicz A.
        • et al.
        Navitor valve - a new TAVI solution for patients with aortic stenosis.
        Kardiol Pol. 2021; 79: 1278-1279
        • Tugaoen Z.
        • Nguyen P.
        • Arora S.
        • Vavalle J.
        The selection of transcatheter heart valves in transcatheter aortic valve replacement.
        Trends Cardiovasc Med. 2022; 32: 513-522
        • Smith D.
        One-year outcomes from a next generation TAVR device with an active sealing cuff. Paris, France.
        EuroPCR. 2022;
        • Boreskie K.F.
        • Hay J.L.
        • Boreskie P.E.
        • Arora R.C.
        • Duhamel T.A.
        Frailty-aware care: giving value to frailty assessment across different healthcare settings.
        BMC Geriatr. 2022; 22: 13