Advanced search

  • Cardiology Journal
  • Vol 24, No 6 (2017) State-of-the-art of transcatheter treatment of aortic valve stenosis and the overview of the InFlow project aiming at developing the first Polish TAVI system
Vol 24, No 6 (2017)
Review articles — Interventional cardiology
Published online: 2017-11-17

open access

View PDF Download PDF file
Page views 1887
Article views/downloads 1716
Get Citation

Connect on Social Media

Connect on Social Media

State-of-the-art of transcatheter treatment of aortic valve stenosis and the overview of the InFlow project aiming at developing the first Polish TAVI system

Mateusz Kachel1, Krzysztof Milewski12, Piotr Buszman13, Magdalena Michalak1, Wojciech Domaradzki1, Witold Gerber1, Joanna Śliwka34, Jerzy Nożyński34, Michał Sobota5, Piotr Hirnle12, Marzena Białek-Brodocz6, Michał Zembala34, Mariusz Pawlak7, Emil Płowiecki8, Janusz Kasperczyk5, Arkadiusz Mężyk7, Andrzej Bochenek1, Paweł Buszman14
DOI: 10.5603/CJ.a2017.0134
Pubmed: 29168542
Cardiol J 2017;24(6):685-694.

Abstract

Initial experience of transcatheter aortic valve implantation (TAVI) or replacement (TAVR) has ap-peared as a promising minimally invasive technology for patients disqualified from surgical treatment (SAVR). Safety and efficacy of TAVI has been analyzed and assessed through numerous registries and trials. Furthermore, results obtained from comparative TAVI vs. SAVR trials proved that both treat¬ments can be considered equal in terms of post-procedural mortality and morbidity in high-risk, as well as lower risk patients. However, there are still some issues that have to be addressed, such as higher chance of paravalvular leakage, vascular injuries, conduction disturbances, malpositioning and the yet unmet problem of insufficient biological valves durability. Recent technological developments along with the learning curve of operators prove a great potential for improvement of TAVI and a chance of surpassing SAVR in various groups of patients in the near future. In pursuit of finding new solutions, the CardValve Consortium consisting of leading scientific and research institutions in Poland has been created. Under the name of InFlow and financial support from the National Center for Research and Development, they have started a project with the aim to design, create and implement into clinical practice the first, Polish, low-profile TAVI valve system, utilizing not only biological but also artificial, polymeric-based prosthesis. This review focuses on current developments in TAVI technologies including the InFlow project.

Keywords: aortic stenosisTAVIprosthetic valvesInFlow

Article available in PDF format

View PDF Download PDF file

References

  1. Nkomo VT, Gardin TN, Skelton JS, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006; 368(9540): 1005–1011.
  2. Vahanian A, Alfieri, O, Andreotti F, et al. ESC Committee for Practice Guidelines (CPG), Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC), European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012; 42(4): S1–44.
    CrossRefPubMed
  3. Dal-Bianco JP, Khandheria BK, Mookadam F, et al. Management of asymptomatic severe aortic stenosis. J Am Coll Cardiol. 2008; 52(16): 1279–1292.
    CrossRefPubMed
  4. Iung B, Cachier A, Baron G, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J. 2005; 26(24): 2714–2720.
    CrossRefPubMed
  5. Cribier A. Development of transcatheter aortic valve implantation (TAVI): a 20-year odyssey. Arch Cardiovasc Dis. 2012; 105(3): 146–52.
    CrossRefPubMed
  6. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002; 106(24): 3006–3008.
    PubMed
  7. Di Mario C, Eltchaninoff H, Moat N, et al. Transcatheter Valve Treatment Sentinel Registry (TCVT) Investigators of the EURObservational Research Programme (EORP) of the European Society of Cardiology. The 2011-12 pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: in-hospital results in 4,571 patients. EuroIntervention. 2013; 8(12): 1362–1371.
    CrossRefPubMed
  8. Kapadia SR, Leon MB, Makkar RR, et al. PARTNER trial investigators. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015; 385(9986): 2485–2491.
    CrossRefPubMed
  9. Nielsen HH, Klaaborg KE, Nissen H, et al. A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial. EuroIntervention. 2012; 8(3): 383–389.
    CrossRefPubMed
  10. Siontis GCM, Praz F, Pilgrim T, et al. Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of severe aortic stenosis: a meta-analysis of randomized trials. Eur Heart J. 2016; 37(47): 3503–3512.
    CrossRefPubMed
  11. Mack MJ, Leon MB, Smith CR, et al. PARTNER 1 trial investigators. 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(9986): 2477–2484.
    CrossRefPubMed
  12. Deeb GM, Reardon MJ, Chetcuti S, et al. CoreValve US Clinical Investigators. 3-Year Outcomes in High-Risk Patients Who Underwent Surgical or Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2016; 67(22): 2565–2574.
    CrossRefPubMed
  13. Søndergaard L, Steinbrüchel DA, Ihlemann N, et al. Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement: The All-Comers Nordic Aortic Valve Intervention Randomized Clinical Trial. Circ Cardiovasc Interv. 2016; 9(6): e003665.
    CrossRefPubMed
  14. Sondergaard L. Clinical, safety and echocardiographic outcomes from the NOTION trial: 4 year follow-up data in all-comer patients with severe aortic valve stenosis, 2017.
  15. Leon MB, Smith CR, Mack MJ, et al. for the PARTNER 2 Investigators. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016; 374(17): 1609–1620.
    CrossRef
  16. Reardon MJ, Van Mieghem NM, Popma JJ, et al. SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017; 376(14): 1321–1331.
    CrossRefPubMed
  17. Mylotte D, Osnabrugge R, Windecker S, et al. Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. J Am Coll Cardiol. 2013; 62(3): 210–219.
    CrossRefPubMed
  18. Fraccaro C, Napodano M, Tarantini G. Conduction disorders in the setting of transcatheter aortic valve implantation: a clinical perspective. Catheter Cardiovasc Interv. 2013; 81(7): 1217–1223.
    CrossRefPubMed
  19. Mollmann H, Kim WK, Kempfert J, et al. Complications of transcatheter aortic valve implantation (TAVI): how to avoid and treat them. Heart. 2015; 101(11): 900–908.
    CrossRefPubMed
  20. Ghanem A, Naderi AS, Frerker C, et al. Mechanisms and Prevention of TAVI-related cerebrovascular events. Curr Pharm Des. 2016; 22(13): 1879–1887.
    PubMed
  21. Bourantas CV, Serruys PW. Evolution of transcatheter aortic valve replacement. Circ Res. 2014; 114(6): 1037–1051.
    CrossRefPubMed
  22. Ribeiro HB, Urena M, Kuck KH, et al. Edwards CENTERA valve. EuroIntervention. 2012; 8(Suppl Q): Q79–82.
    CrossRefPubMed
  23. Arsalan M, Walther T. Durability of prostheses for transcatheter aortic valve implantation. Nat Rev Cardiol. 2016; 13(6): 360–367.
    CrossRefPubMed
  24. Kariori M, Kalogeras K, Vavuranakis M. The next era of transcatheter aortic valve implantation (TAVI): fully repositionable, re-sheathable and retrievable prostheses? Hosp Chron. 2014; 9(No 2).
  25. Abramowitz Y, Chakravarty T, Jilaihawi H, et al. Update on New Devices for Transcatheter Aortic Valve Replacement. J Struct Heart Dis. 2015; 1(3): 112–126.
    CrossRef
  26. Jones BM, Krishnaswamy A. New TAVR Devices: European Experience and Status of US Trials. Cardiac Interventions Today. 2016; 10(2).
  27. Kleiman NS, Reardon MJ. Advances in transcatheter aortic valve replacement. Methodist Debakey Cardiovasc J. 2016; 12(1): 33–36.
    CrossRefPubMed
  28. Herrmann HC, Thourani VH, Kodali SK, et al. PARTNER Investigators. One-Year Clinical Outcomes With SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients With Severe Aortic Stenosis. Circulation. 2016; 134(2): 130–140.
    CrossRefPubMed
  29. O'Riordan M. Boston Scientific Recalls All Lotus Valves, Including Lotus With Depth Guard. http://www.tctmd.com (2017).
  30. Manoharan G. Clinical Outcomes at 1 Year with a Repositionable Self-Expanding Transcatheter Aortic Valve, Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting October 12, 2015.
  31. Forrest JK. 30-Day Safety and Echocardiographic Outcomes Following Transcatheter Aortic Valve Replacement with the Self-Expanding Repositionable Evolut PRO System 2017.
  32. ACC 2017: FDA approves launch of CoreValve Evolut Pro, Cardiovascular News 2017.
  33. Meredith IT, Hood KL, Haratani N, et al. Boston Scientific Lotus valve. EuroIntervention. 2012; 8(Suppl Q): Q70–Q74.
    CrossRefPubMed
  34. Meredith IT, Walters DL, Dumonteil N, et al. 1-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results of the REPRISE II Study. JACC Cardiovasc Interv. 2016; 9(4): 376–384.
    CrossRefPubMed
  35. M. I. T. First Report of Discharge/7-day Results from the Lotus Edge Feasibility Trial, TCT 2016.
  36. Treede H, Rastan A, Ferrari M, et al. JenaValve. EuroIntervention. 2012; 8(Suppl Q): Q88–Q93.
    CrossRefPubMed
  37. Manoharan G, Spence MS, Rodes-Cabau J, et al. St Jude Medical Portico valve. EuroIntervention. 2012; 8(Suppl Q): Q97–Q101.
    CrossRefPubMed
  38. Perlman G, Cheung A, Dumont E, et al. Transcatheter aortic valve replacement with the Portico valve: one-year results of the early Canadian experience. EuroIntervention. 2017; 12(13): 1653–1659.
    CrossRefPubMed
  39. Bijuklic K, Tubler T, Low RI, et al. Direct Flow Medical valve. EuroIntervention. 2012; 8(Suppl Q): Q75–Q78.
  40. Latib A, Maisano F, Colombo A, et al. Transcatheter aortic valve implantation of the direct flow medical aortic valve with minimal or no contrast. Cardiovasc Revasc Med. 2014; 15(4): 252–257.
    CrossRefPubMed
  41. TAVI company Direct Flow Medical closes after failing to secure funding, 2017.
  42. EuroPCR 2017: Excellent early outcomes for Edwards Lifesciences’ self-expanding valve, 2017.
  43. Tchetche D. 30-day Outcomes of the CENTERA Trial - a New Self-Expanding Transcatheter Heart Valve, 2017.
  44. Bagur R, Teefy PJ, Kiaii B, et al. First North American experience with the transfemoral ACURATE-neoTM self-expanding transcatheter aortic bioprosthesis. Catheter Cardiovasc Interv. 2017; 90(1): 130–138.
    CrossRefPubMed
  45. Sundermann SH, Grunenfelder J, Corti R, et al. Feasibility of the Engager™ aortic transcatheter valve system using a flexible over-the-wire design. Eur J Cardiothorac Surg. 2012; 42(4): e48–e52.
    CrossRefPubMed
  46. Sundermann SH, Holzhey D, Bleiziffer S, et al. Second-generation transapical valves: the Medtronic Engager system. Multimed Man Cardiothorac Surg. 2014; 2014: mmu001.
    CrossRefPubMed
  47. Mollmann H, Walther T, Siqueira D, et al. Transfemoral TAVI using the self-expanding ACURATE neo prosthesis: one-year outcomes of the multicentre. EuroIntervention. 2017; 13(9): e1040–e1046.
    CrossRefPubMed
  48. Medtronic 23mm EngagerTM Transcatheter Aortic Bioprosthesis. Model: ME-TA2-B23. Patient Management Recommendations and Recall, 2015.
  49. Halapas A, Chrissoheris M, Bouboulis N, et al. Update on current TAVI technology, indications, screening, and outcomes. Contin Cardiol Edu. 2016; 2: 37–46.
    CrossRef
  50. Mężyk A, Jureczko P, Machoczek T, Konopelska A, Pawlak M. Tensile tests of porcine pericardial tissue for aortic heart valve leaflets. CRC Press/Balkema, Cape Town 2016: 618–623.
  51. Mezyk A, Klein W, Pawlak M, et al. Preliminary tests of new composite material based on shape memory alloys for artificial aortic valve leaflets. IEEE. 2016: 1–3.
    CrossRef
  52. Pawlak M, Klein W, Gniłka J, et al. Numerical modeling of leaflets for artificial aortic valves with SPH method. CMBE. 2017: 1288–1291.

About cookies

Necessary cookies

Allways active

These cookies are necessary for the proper display and operation of the website. Blocking them may cause the website to malfunction.

Analytical cookies

As part of our website, we use analytical tools, such as Google Analytics, that allow us to verify website traffic. These tools may require the use of cookies.

Community cookies

These are cookies associated with the social networks we use. Accepting them will allow us to associate your visit to the site with our social media profiles.

Marketing cookies

These are cookies responsible for carrying out advertising and marketing activities - consenting to their use will allow us to target you with advertisements based on your previous activities within our website.

Copyright © 2023-2024 Via Medica Regulations Cookie policy Privacy Statement Legal Note