open access

Vol 24, No 6 (2017)
Review articles — Interventional cardiology
Published online: 2017-11-17
Get Citation

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 Kachel, Krzysztof Milewski, Piotr Buszman, Magdalena Michalak, Wojciech Domaradzki, Witold Gerber, Joanna Śliwka, Jerzy Nożyński, Michał Sobota, Piotr Hirnle, Marzena Białek-Brodocz, Michał Zembala, Mariusz Pawlak, Emil Płowiecki, Janusz Kasperczyk, Arkadiusz Mężyk, Andrzej Bochenek, Paweł Buszman
DOI: 10.5603/CJ.a2017.0134
·
Pubmed: 29168542
·
Cardiol J 2017;24(6):685-694.

open access

Vol 24, No 6 (2017)
Review articles — Interventional cardiology
Published online: 2017-11-17

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.

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.
Get Citation

Keywords

aortic stenosis, TAVI, prosthetic valves, InFlow

About this article
Title

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

Journal

Cardiology Journal

Issue

Vol 24, No 6 (2017)

Pages

685-694

Published online

2017-11-17

DOI

10.5603/CJ.a2017.0134

Pubmed

29168542

Bibliographic record

Cardiol J 2017;24(6):685-694.

Keywords

aortic stenosis
TAVI
prosthetic valves
InFlow

Authors

Mateusz Kachel
Krzysztof Milewski
Piotr Buszman
Magdalena Michalak
Wojciech Domaradzki
Witold Gerber
Joanna Śliwka
Jerzy Nożyński
Michał Sobota
Piotr Hirnle
Marzena Białek-Brodocz
Michał Zembala
Mariusz Pawlak
Emil Płowiecki
Janusz Kasperczyk
Arkadiusz Mężyk
Andrzej Bochenek
Paweł Buszman

References (52)
  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.
  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.
  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.
  5. Cribier A. Development of transcatheter aortic valve implantation (TAVI): a 20-year odyssey. Arch Cardiovasc Dis. 2012; 105(3): 146–52.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  21. Bourantas CV, Serruys PW. Evolution of transcatheter aortic valve replacement. Circ Res. 2014; 114(6): 1037–1051.
  22. Ribeiro HB, Urena M, Kuck KH, et al. Edwards CENTERA valve. EuroIntervention. 2012; 8(Suppl Q): Q79–82.
  23. Arsalan M, Walther T. Durability of prostheses for transcatheter aortic valve implantation. Nat Rev Cardiol. 2016; 13(6): 360–367.
  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.
  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.
  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.
  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.
  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.
  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.
  37. Manoharan G, Spence MS, Rodes-Cabau J, et al. St Jude Medical Portico valve. EuroIntervention. 2012; 8(Suppl Q): Q97–Q101.
  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.
  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.
  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.
  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.
  46. Sundermann SH, Holzhey D, Bleiziffer S, et al. Second-generation transapical valves: the Medtronic Engager system. Multimed Man Cardiothorac Surg. 2014; 2014: mmu001.
  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.
  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.
  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.
  52. Pawlak M, Klein W, Gniłka J, et al. Numerical modeling of leaflets for artificial aortic valves with SPH method. CMBE. 2017: 1288–1291.

Important: This website uses cookies. More >>

The cookies allow us to identify your computer and find out details about your last visit. They remembering whether you've visited the site before, so that you remain logged in - or to help us work out how many new website visitors we get each month. Most internet browsers accept cookies automatically, but you can change the settings of your browser to erase cookies or prevent automatic acceptance if you prefer.

By "Via Medica sp. z o.o." sp.k., ul. Świętokrzyska 73, 80–180 Gdańsk, Poland
tel.:+48 58 320 94 94, fax:+48 58 320 94 60, e-mail: viamedica@viamedica.pl