CoreValve® transcatheter self-expandable aortic bioprosthesis

Expert Review of Medical Devices

Volumn 10, Issue 1, 2013, Pages 15-26

  Bruschi, Giuseppe ^a   De Marco, Federico ^a   Martinelli, Luigi ^a   Klugmann, Silvio ^a  

^a OSPEDALE NIGUARDA CA GRANDA   (Italy)

Author keywords

aortic stenosis; catheter based valve intervention; CoreValve ; structural heart disease; transcatheter technique

Indexed keywords

AORTIC STENOSIS; AORTIC VALVES; BIOPROSTHESIS; CATHETER-BASED VALVE INTERVENTION; DIAMOND CELLS; FEMORAL ARTERY; HEART DISEASE; SELF-EXPANDABLE; TRANSCATHETER TECHNIQUE;

BLOOD VESSELS; CATHETERS; DISEASES; TISSUE;

PATIENT TREATMENT;

ACETYLSALICYLIC ACID; CEPHALOSPORIN; CLOPIDOGREL; LOW MOLECULAR WEIGHT HEPARIN; NITINOL; SODIUM CHLORIDE;

ANTIBIOTIC THERAPY; AORTA VALVE; AORTA VALVE PROSTHESIS; AORTA VALVE STENOSIS; ARTERY CATHETER; ARTICLE; AXILLARY ARTERY; BALLOON DILATATION; BELGIUM; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL (TOPIC); COHORT ANALYSIS; COMPUTED TOMOGRAPHIC ANGIOGRAPHY; COMPUTER ASSISTED TOMOGRAPHY; CORONARY ARTERY OBSTRUCTION; DEVICE SAFETY; DISEASE REGISTRY; DISEASE SEVERITY; DRUG DELIVERY DEVICE; ERYTHROCYTE TRANSFUSION; FEMORAL ARTERY; FOLLOW UP; FRANCE; GUIDE WIRE; HEALTH CARE COST; HEART CATHETERIZATION; HEART INFARCTION; HEART MUSCLE CONDUCTION DISTURBANCE; HEART VALVE REGURGITATION; HIGH RISK PATIENT; HUMAN; ITALY; LOADING DRUG DOSE; LONG TERM CARE; MORBIDITY; MULTICENTER STUDY (TOPIC); NITINOL STENT; PARAVALVULAR REGURGITATION; PERICARDIAL TISSUE; PERICARDIUM; POSTMARKETING SURVEILLANCE; POSTOPERATIVE CARE; POSTOPERATIVE HEMORRHAGE; POSTOPERATIVE INFECTION; SELF EXPANDING STENT; SPAIN; SUBCLAVIAN ARTERY; SURGICAL ANATOMY; SURGICAL APPROACH; SURGICAL MORTALITY; SYMPTOM; TRANSCATHETER AORTIC VALVE IMPLANTATION; TRANSESOPHAGEAL ECHOCARDIOGRAPHY; UNITED KINGDOM; UNITED STATES;

AORTIC VALVE; AORTIC VALVE STENOSIS; BIOPROSTHESIS; CARDIAC CATHETERS; EQUIPMENT FAILURE ANALYSIS; HEART VALVE PROSTHESIS; HUMANS; PROSTHESIS DESIGN;

SUS;

EID: 84871988705     PISSN: 17434440     EISSN: 17452422     Source Type: Journal    
DOI: 10.1586/erd.12.64     Document Type: Article

References (41)

1. Lindroos M, Kupari M, Heikkila J, Tilvis R. Prevalence of aortic valve abnormalities in the elderly: An echocardiographic study of a random population sample. J. Am. Coll. Cardiol. 2, 1220-1225 (1993). (Pubitemid 23106200)
2. Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: A population-based study. Lancet 368(9540), 1005-1011 (2006). (Pubitemid 44353666)
3. Otto CM, Lind BK, Kitzman DW, Gersh BJ, Siscovick DS. Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly. N. Engl. J. Med. 341(3), 142-147 (1999). (Pubitemid 29325741)
4. Carabello BA. Clinical practice. Aortic stenosis. N. Engl. J. Med. 346(9), 677-682 (2002).
5. Bonow RO, Carabello BA, Chatterjee K et al.; 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); Society of Cardiovascular Anesthesiologists. 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. 48(3), e1-148 (2006).
6. Bach DS, Cimino N, Deeb GM. Unoperated patients with severe aortic stenosis. J. Am. Coll. Cardiol. 50(20), 2018-2019 (2007). (Pubitemid 350046335)
7. 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. 26(24), 2714-2720 (2005). (Pubitemid 41746694)
8. Iung B, Baron G, Butchart EG et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on valvular heart disease. Eur. Heart J. 24(13), 1231-1243 (2003). (Pubitemid 36834640)
9. Chiappini B, Camurri N, Loforte A, Di Marco L, Di Bartolomeo R, Marinelli G. Outcome after aortic valve replacement in octogenarians. Ann. Thorac. Surg. 78, 85-59 (2004).
10. Kolh P, Kerzmann A, Honore C, Comte L, Limet R. Aortic valve surgery in octogenarians: Predictive factors for operative and long-term results. Eur. J. Cardiothorac. Surg. 31(4), 600-606 (2007). (Pubitemid 46400496)
11. Elayada MA, Hall RJ, Reul RM et al. Aortic valve replacement in patients 80 years and older: Operative risks and long-term results. Circulation 88, 11-16 (1993). (Pubitemid 23324537)
12. Collart F, Feier H, Kerbaul F et al. Valvular surgery in octogenarians: Operative risks factors, evaluation of EuroScore and long term results. Eur. J. Cardiothorac. Surg. 27(2), 276-280 (2005). (Pubitemid 40193137)
13. Charlson E, Legedza AT, Hamel MB. Decision-making and outcomes in severe symptomatic aortic stenosis. J. Heart Valve Dis. 15(3), 312-321 (2006).
14. Andersen HR, Knudsen LL, Hasenkam JM. Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs. Eur. Heart J. 13(5), 704-708 (1992).
15. 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 106(24), 3006-3008 (2002). (Pubitemid 35440280)
16. Webb JG, Chandavimol M, Thompson CR et al. Percutaneous aortic valve implantation retrograde from the femoral artery. Circulation 113(6), 842-850 (2006).
17. Grube E, Buellesfeld L, Mueller R et al. Progress and current status of percutaneous aortic valve replacement: Results of three device generations of the CoreValve Revalving system. Circ. Cardiovasc. Interv. 1(3), 167-175 (2008).
18. Ye J, Cheung A, Lichtenstein SV et al. Transapical aortic valve implantation in humans. J. Thorac. Cardiovasc. Surg. 131(5), 1194-1196 (2006).
19. Petronio AS, De Carlo M, Bedogni F et al. Safety and efficacy of the subclavian approach for transcatheter aortic valve implantation with the CoreValve Revalving system. Circ. Cardiovasc. Interv. 3(4), 359-366 (2010).
20. Bauernschmitt R, Schreiber C, Bleiziffer S et al. Transcatheter aortic valve implantation through the ascending aorta: An alternative option for no-access patients. Heart Surg. Forum 12(1), E63-E64 (2009).
21. Michiels R. CoreValve ReValving System for percutaneous aortic valve replacement. In: Transcatheter Aortic Valve Implantation Y Tips and Tricks to Avoid Failure. Serruys PW, Piazza N, Cribier A, Webb JG, Laborde JC, De Jaegere P (Eds). Informa Healthcare, NY, USA, 94-101 (2010).
22. Leon MB, Kodali S, Williams M et al. Transcatheter aortic valve replacement in patients with critical aortic stenosis: Rationale, device descriptions, early clinical experiences, and perspectives. Semin. Thorac. Cardiovasc. Surg. 18(2), 165-174 (2006). (Pubitemid 44835260)
23. García Páez JM, Carrera A, Herrero EJ et al. Influence of the selection of the suture material on the mechanical behavior of a biomaterial to be employed in the construction of implants. Part 2: Porcine pericardium. J. Biomater. Appl. 16(1), 68-90 (2001). (Pubitemid 32715438)
24. Grube E, Laborde JC, Gerckens U et al. Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: The Siegburg first-in-man study. Circulation 114(15), 1616-1624 (2006). (Pubitemid 44547432)
25. Grube E, Schuler G, Buellesfeld L et al. Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: Device success and 30-day clinical outcome. J. Am. Coll. Cardiol. 50(1), 69-76 (2007). (Pubitemid 46970878)
26. Piazza N, Grube E, Gerckens U et al. Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) corevalve revalving system: Results from the multicentre, expanded evaluation registry 1-year following CE mark approval. EuroIntervention 4(2), 242-249 (2008).
27. Tamburino C, Capodanno D, Ramondo A et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation 123(3), 299-308 (2011).
28. Ussia GP, Barbanti M, Petronio AS et al.; CoreValve Italian Registry Investigators. Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur. Heart J. 33(8), 969-976 (2012).
29. Bosmans JM, Kefer J, De Bruyne B et al.; Belgian TAVI Registry Participants. Procedural, 30-day and one year outcome following CoreValve or Edwards transcatheter aortic valve implantation: Results of the Belgian National Registry. Interact. Cardiovasc. Thorac. Surg. 12(5), 762-767 (2011).
30. Moat NE, Ludman P, De Belder MA. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis. The U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J. Am. Coll. Cardiol. 58, 2130-2138 (2011).
31. Eltchaninoff H, Prat A, Gilard M et al.; FRANCE Registry Investigators. Transcatheter aortic valve implantation: Early results of the FRANCE (FRench Aortic National CoreValve and Edwards) Registry. Eur. Heart J. 32(2), 191-197 (2011).
32. Avanzas P, Muñoz-García AJ, Segura J et al. Percutaneous implantation of the CoreValve self-expanding aortic valve prosthesis in patients with severe aortic stenosis: Early experience in Spain. Rev. Esp. Cardiol. 63(2), 141-148 (2010).
33. Leon M, Piazza N, Nikolsky E et al. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials Y a consensus report from the Valve Academic Research Consortium. J. Am. Coll. Cardiol. 57, 253-269 (2011).
34. Bruschi G, Fratto P, De Marco F et al. The trans-subclavian retrograde approach for transcatheter aortic valve replacement: Single-center experience. J. Thorac. Cardiovasc. Surg. 140(4), 911-915, 915.e1 (2010).
35. Laborde JC; On behalf of CoreValve PAVR Registry Participants. Aortic valve implantation by subclavian access site. Presented at: EuroPCR 2009. Barcelona, Spain 19-22 May 2009.
36. Caceres M, Braud R, Roselli EE. The axillary/subclavian artery access route for transcatheter aortic valve replacement: A systematic review of the literature. Ann. Thorac. Surg. 93(3), 1013-1018 (2012).
37. Bruschi G, De Marco F, Fratto P et al. Direct aortic access through right minithoracotomy for implantation of self-expanding aortic bioprosthetic valves. J. Thorac. Cardiovasc. Surg. 140(3), 715-717 (2010).
38. Moat N, Laborde JC, Bruschi G; on behalf of the EU CoreValve collaborative group. European experience of direct aortic TAVI with a self-expanding prosthesis. STS 48th Annual Meeting Late-Breaking Clinical Trial Abstract Presentations. Fort Lauderdale, FL, USA, 29 JanuaryY1 February 2012.
39. Watt M, Mealing S, Eaton J et al. CostYeffectiveness of transcatheter aortic valve replacement in patients ineligible for conventional aortic valve replacement. Heart 98(5), 370-376 (2012).
40. Leon MB, Smith CR, Mack M et al.; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N. Engl. J. Med. 363(17), 1597-1607 (2010).
41. Reynolds MR, Magnuson EA, Wang K et al.; PARTNER Investigators. Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: Results from the placement of aortic transcatheter valves (PARTNER) Trial (Cohort B). Circulation 125(9), 1102-1109 (2012).