Псевдоаневризмы после имплантации бесстентового свиного биопротеза аорты Medtronic Freestyle: клинические и патологические аспекты
Глубокий ретроспективный систематический обзор для профессионалов сердечно-сосудистой хирургии, раскрывающий риски псевдоаневризм после имплантации бесстентового биопротеза Medtronic Freestyle (MFB) при полной замене корня аорты! Анализ 42 случаев (данные Duke University Medical Center, база MAUDE FDA, мировая литература 1997–2013) показывает частоту осложнения от 1.1% (95% CI, 0.5–2.0%) до 4.7% (95% CI, 1.3–11.5%) при регулярной визуализации, с летальностью 15.4%. Гистопатология выявляет макрофагальную инфильтрацию, указывающую на иммунный ответ как причину деградации протеза, особенно у крупных клапанов (23–29 мм), тогда как размеры 19–21 мм безопасны.
Статья (10 страниц основного текста, 21 страница с литературой и приложением) включает 3 таблицы в тексте и 4-страничное приложение с двумя графиками (кривая Каплана-Мейера, сравнение частоты псевдоаневризм) и реальными иллюстрациями (КТ-ангиография, интраоперационные фото с указателями, гистологические снимки). Рекомендации по ежегодной КТ/МР-ангиографии и отбору пациентов делают работу must-have для хирургов, медперсонала отделения кардиохирургии и учёных. Идеальна для публикации в топовых журналах или клинической практики.
1. Gillum, R.F.
Epidemiology of aortic aneurysm in the United States J Clin Epidemiol. 1995; 48:1289-1298
2. Williams, J.B. Peterson, E.D. Zhao, Y. ...
Contemporary results for proximal aortic replacement in North America
J Am Coll Cardiol. 2012; 60:1156-1162
3. Brown, J.M. OBrien, S.M. Wu, C. ...
Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database
J Thorac Cardiovasc Surg. 2009; 137:82-90
4. Chen, W. Schoen, F.J. Levy, R.J.
Mechanism of efficacy of 2-amino oleic acid for inhibition of calcification of glutaraldehyde-pretreated porcine bioprosthetic heart valves
Circulation. 1994; 90:323-329
5. Bach, D.S. Kon, N.D. Dumesnil, J.G. ...
Ten-year outcome after aortic valve replacement with the freestyle stentless bioprosthesis
Ann Thorac Surg. 2005; 80:480-486
6. Ozaki, N. Hino, Y. Hanafusa, Y. ...
Perforation of the Valsalva sinus after implantation of Medtronic Freestyle aortic bioprosthesis
Ann Thorac Surg. 2006; 82:2282-2285
7. Butany, J. Zhou, T. Leong, S.W. ...
Inflammation and infection in nine surgically explanted Medtronic Freestyle stentless aortic valves
Cardiovasc Pathol. 2007; 16:258-267
8. Nair, V. Law, K.B. Li, A.Y. ...
Characterizing the inflammatory reaction in explanted Medtronic Freestyle stentless porcine aortic bioprosthesis over a 6-year period
Cardiovasc Pathol. 2012; 21:158-168
9. Mizuno, T.
Wall rupture of Medtronic Freestyle stentless porcine aortic root bioprosthesis
Interact Cardiovasc Thorac Surg. 2008; 7:1129-1130
10. David, T.E. Armstrong, S. Maganti, M. ...
Postimplantation morphologic changes of glutaraldehyde-fixed porcine aortic roots and risk of aneurysm and rupture
J Thorac Cardiovasc Surg. 2009; 137:94-100
11. Horvath, M.M. Winfield, S. Evans, S. ...
The DEDUCE Guided Query tool: providing simplified access to clinical data for research and quality improvement
J Biomed Inform. 2011; 44:266-276
12. U.S. Food and Drug Administration. Manufacturer and User Facility Device Experience Database - (MAUDE). Available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm127891.htm. Accessed February 27, 2013.
13. U.S. Food and Drug Administration. MAUDE-Manufacturer and User Facility Device Experience Online Search. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. Accessed February 27, 2013.
14. Mazzola, A. Di Mauro, M. Pellone, F. ...
Freestyle aortic root bioprosthesis is a suitable alternative for aortic root replacement in elderly patients: a propensity score study
Ann Thorac Surg. 2012; 94:1185-1190
15. Smith, C.R. Stamou, S.C. Hooker, R.L. ...
Stentless root bioprosthesis for repair of acute type A aortic dissection
J Thorac Cardiovasc Surg. 2013; 145:1540-1544
16. LeMaire, S.A. Green, S.Y. Sharma, K. ...
Aortic root replacement with stentless porcine xenografts: early and late outcomes in 132 patients
Ann Thorac Sur. 2009; 87:503-512
17. El-Hamamsy, I. Clark, L. Stevens, L.M. ...
Late outcomes following freestyle versus homograft aortic root replacement: results from a prospective randomized trial
J Am Coll Cardiol. 2010; 55:368-376
18. Mohammadi, S. Baillot, R. Voisine, P. ...
Structural deterioration of the Freestyle aortic valve: mode of presentation and mechanisms
J Thorac Cardiovasc Surg. 2006; 132:401-406
19. Ennker, J.A. Albert, A.A. Rosendahl, U.P. ...
Ten-year experience with stentless aortic valves: full-root versus subcoronary implantation
Ann Thorac Surg. 2008; 85:445-452
20. Kameda, Y. Mizuguchi, K. Kuwata, T. ...
Aortopulmonary fistula due to perforation of the aortic wall of a freestyle stentless valve
Ann Thorac Surg. 2004; 78:1827-1829
21. Pacini, D. Ranocchi, F. Angeli, E. ...
Aortic root replacement with composite valve graft
Ann Thorac Surg. 2003; 76:90-98
22. Manji, R.A. Zhu, L.F. Nijjar, N.K. ...
Glutaraldehyde-fixed bioprosthetic heart valve conduits calcify and fail from xenograft rejection
Circulation. 2006; 114:318-327
23. Naso, F. Gandaglia, A. Bottio, T. ...
First quantification of alpha-Gal epitope in current glutaraldehyde-fixed heart valve bioprostheses
Xenotransplantation. 2013; 2:252-261
24. Mills, N.L. Morgenstern, D.A. Gaudiani, V.A. ...
"Legs" technique for management of widely separated coronary arteries during ascending aortic repair
Ann Thorac Surg. 1996; 61:869-874
25. Cabrol, C. Pavie, A. Mesnildrey, P. ...
Long-term results with total replacement of the ascending aorta and reimplantation of the coronary arteries
J Thorac Cardiovasc Surg. 1986; 91:17-25
