Mid-term results of open transaortic implantation of the «MedLab-CT» prosthesis: prospective clinical study



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Abstract

Aim. To evaluate the mid-term clinical and hemodynamic results of open transaortic implantation of the balloon-expandable prosthesis «MedLab-CT» in patients with high surgical risk.

Material and methods. The study included 41 patients (mean age 65.7±11.7 years) who underwent open implantation of the «MedLab-CT» (MedInzh, Russia) aortic valve (AV) prosthesis under cardiopulmonary bypass and cardioplegia, belonging to the cohort of high surgical risk according to the data EuroSCORE II scale, with critical symptomatic aortic stenosis, high functional class according to the classification of the New York Heart Association (NYHA). All studied patients had clinical indications for transcatheter AV replacement, however, given the concomitant surgical pathology of the heart (critical multivessel coronary artery disease unsuitable for endovascular treatment and/or damage to other valves), as well as the morphological features of the aortic root («low» location coronary artery ostia relative to the annulus fibrosus of the AV, large calcifications of the coronary cusps according to computed tomography, with a high risk of ostium occlusion), they were denied a minimally invasive procedure. The incidence of adverse clinical events and hemodynamic parameters of the AV prosthesis in the medium-term period were assessed.

Results. The average follow-up period was 13.1 months, the maximum was 3 years. Mortality – 2.4% (n=1), there were no cases of stroke. The average gradient in the long-term period on AK «MedLab-CT» is 8.5±3.1 mm Hg. Paravalvular regurgitation above grade 2 and transvalvular regurgitation were not detected. Thus, no cases of dysfunction of the aortic prosthesis were noted.

Conclusion. In the medium term, satisfactory clinical and hemodynamic results of open implantation of the «MedLab-CT» balloon-expandable prosthesis were obtained in high surgical risk patients.

About the authors

Vladlen V. Bazylev

Federal Center for Cardiovascular Surgery

Email: yaroslav.slastin@yandex.ru
ORCID iD: 0000-0001-6089-9722

MD, D. Sci. (Med.), Prof.

Russian Federation, Penza

Andrey A. Voevodin

Federal Center for Cardiovascular Surgery

Email: yaroslav.slastin@yandex.ru
ORCID iD: 0000-0002-7078-1274

MD, Cand. Sci. (Med.)

Russian Federation, Penza

Yaroslav S. Slastin

Federal Center for Cardiovascular Surgery

Email: yaroslav.slastin@yandex.ru
ORCID iD: 0000-0002-4962-7651

cardio-vascular surgeon

Russian Federation, Penza

Alena A. Kuznetsova

Federal Center for Cardiovascular Surgery

Email: kuznecova-alena2@mail.ru

resident

Russian Federation, Penza

Mihir P. Patel

Federal Center for Cardiovascular Surgery

Author for correspondence.
Email: yaroslav.slastin@yandex.ru
ORCID iD: 0000-0003-3440-3898

resident

Russian Federation, Penza

References

  1. Carabello BA, Paulus WJ. Aortic stenosis. Lancet. 2009;373(9667):956-66. doi: 10.1016/S0140-6736(09)60211-7
  2. Bonow RO, Carabello BA, Chatterjee K, et al. ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease) developed in collaboration with the Society of Cardiovascular Anesthesiologists endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. J Am Coll Cardiol. 2006;48(3):e1-148. doi: 10.1016/j.jacc.2006.05.021
  3. Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS), Vahanian A, et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. 2012;33(19):2451-96. doi: 10.1093/eurheartj/ehs109
  4. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(22):e57-185. doi: 10.1016/j.jacc.2014.02.536. Erratum in: J Am Coll Cardiol. 2014;63(22):2489. Dosage error in article text.
  5. Базылев В.В., Воеводин А.Б., Шалыгина А.С. Среднесрочные результаты транскатетерной имплантации протеза аортального клапана МедЛаб-КТ. Российский кардиологический журнал. 2019;24(8):65-9 [Bazylev VV, Voevodin AB, Shalygina AS. Medium-term results of transcatheter implantation of MedLab-CT aortic valve prosthesis. Russian Journal of Cardiology. 2019;24(8):65-9 (in Russian)]. doi: 10.15829/1560-4071-2019-8-65-69
  6. Базылев В.В., Воеводин А.Б., Захарова А.С, Россейкин Е.В. Непосредственные клинические и гемодинамические результаты транскатетерной имплантации протеза аортального клапана «Медлаб-КТ». Патология кровообращения и кардиохирургия. 2018;22(3):17-24 [Bazylev VV, Voyevodin AB, Zakharova AS, Rosseykin EV. Early clinical and hemodynamic results of transcatheter aortic valve implantation using the «MedLab-KT» prosthesis. Patologiya Krovoobrashcheniya i Kardiokhirurgiya. 2018;22(3):17-24 (in Russian)]. DOI:10.21688-1681-3472-2018-3-17-24
  7. Базылев В.В., Воеводин А.Б., Сластин Я.С., Карнахин В.А. Открытая трансаортальная имплантация протеза «МЕДЛАБ-КТ». Ангиология и сосудистая хирургия. 2021;27(3):115-24 [Bazylev VV, Voevodin AB, Slastin IA S, Karnakhin VA. Open transaortic implantation of «Medlab-KT» prosthesis. Angiol Sosud Khir. 2021;27(3):115-24 (in Russian)]. doi: 10.33529/ANGIO2021311
  8. Flameng W, Herregods MC, Hermans H, et al. Effect of sutureless implantation of the Perceval S aortic valve bioprosthesis on intraoperative and early postoperative outcomes. J Thorac Cardiovasc Surg. 2011;142(6):1453-7. doi: 10.1016/j.jtcvs.2011.02.021
  9. Shrestha M, Maeding I, Höffler K, et al. Aortic valve replacement in geriatric patients with small aortic roots: are sutureless valves the future? Interact Cardiovasc Thorac Surg. 2013;17(5):778-82;discussion 782. doi: 10.1093/icvts/ivt291
  10. Sadowski J, Kapelak B, Pfitzner R, et al. Sutureless aortic valve bioprothesis ‘3F/ATS Enable’ – 4.5 years of a single-centre experience. Kardiol Pol. 2009;67(8А):956-63.
  11. Mack MJ, Leon MB, Smith CR, 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(9986):2477-84. doi: 10.1016/S0140-6736(15)60308-7
  12. Базылев В.В., Воеводин А.Б., Сластин Я.С., Потопальский И.Д. Транскатетерная замена клапана легочной артерии со створками из политетрафторэтилена. Ангиология и сосудистая хирургия. 2020;26(1):143-7 [Bazylev VV, Voevodin AB, Slastin IA S, Potopalskii ID. Transcatheter replacement of pulmonary artery valve with a graft containing polytetrafluoroethylene leaflets. Angiol Sosud Khir. 2020;26(1):143-7 (in Russian)]. doi: 10.33529/ANGIO2020123

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