Transcatheter aortic valve implantation: a new standard of care

Nelson, Adam J; Montarello, Nicholas J; Cosgrove, Claudia S; Roberts-Thomson, Ross L; Delacroix, Sinny; Chokka, Ramesh G; Montarello, Joseph K; Worthley, Stephen G

doi:10.5694/mja17.01255

ARTICLE
AUTHORS
REFERENCES

Topics

Anatomy and physiology

Cardiovascular diseases

Summary

Aortic stenosis is the most common valvular lesion requiring intervention and with an ageing population, its burden is likely to increase.
Increasing comorbidity and a desire for less invasive treatment strategies has facilitated the expansion of percutaneous aortic valve therapies.
Robust clinical trial data are now available to support the role of transcatheter aortic valve implantation (TAVI) in patients of prohibitive, high and now intermediate surgical risk.
The introduction of a Medicare Benefits Schedule reimbursement is likely to see TAVI use grow exponentially in Australia over the next 5 years.
Clinical trials evaluating low risk patients may be the final frontier to see TAVI become the standard of care for most patients with severe aortic stenosis.

Royal Adelaide Hospital, Adelaide, SA

Correspondence: adam.nelson@adelaide.edu.au

Competing interests:

Stephen Worthley consults for and has received honoraria from Medtronic and Abbott.

1. Yeh RW, Sidney S, Chandra M, et al. Population trends in the incidence and outcomes of acute myocardial infarction. N Engl J Med 2010; 362: 2155-2165.
2. Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet 2006; 368: 1005-1011.
3. Ross J, Jr., Braunwald E. Aortic stenosis. Circulation 1968; 38: 61-67.
4. Ben-Dor I, Pichard AD, Gonzalez MA, et al. Correlates and causes of death in patients with severe symptomatic aortic stenosis who are not eligible to participate in a clinical trial of transcatheter aortic valve implantation. Circulation 2010; 122: S37-S42.
5. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010; 363: 1597-1607.
6. Harken DE, Soroff HS, Taylor WJ, et al. Partial and complete prostheses in aortic insufficiency. J Thorac Cardiovasc Surg 1960; 40: 744-762.
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 2005; 26: 2714-2720.
8. Layland JJ, Bell B, Mullany D, Walters DL. Percutaneous management of aortic stenosis in high-risk patients. Med J Aust 2010; 192: 520-525. <MJA full text>
9. 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: 3006-3008.
10. Anderson RP. First publications from the Society of Thoracic Surgeons National Database. Ann Thorac Surg 1994; 57: 6-7.
11. O’Brien SM, Shahian DM, Filardo G, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2-isolated valve surgery. Ann Thorac Surg 2009; 88: S23-S42.
12. Kapadia SR, Leon MB, Makkar RR, et al. 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: 2485-2491.
13. Popma JJ, Adams DH, Reardon MJ, et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol 2014; 63: 1972-1981.
14. Kodali S, Thourani VH, White J, et al. Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis. Eur Heart J 2016; 37: 2252-2262.
15. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011; 364: 2187-2198.
16. 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: 2477-2484.
17. Adams DH, Popma JJ, Reardon MJ. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014; 371: 967-968.
18. Reardon MJ, Adams DH, Kleiman NS, et al. 2-year outcomes in patients undergoing surgical or self-expanding transcatheter aortic valve replacement. J Am Coll Cardiol 2015; 66: 113-121.
19. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 2016; 374: 1609-1620.
20. Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med 2017; 376: 1321-1331.
21. Sondergaard L, Steinbruchel 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: e003665.
22. Serruys PW, Morice MC, Kappetein AP, et al. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med 2009; 360: 961-972.
23. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC Focused Update of the 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 Clinical Practice Guidelines. Circulation 2017; 135: e1159-e1195.
24. Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J 2017; 38: 2739-2791.
25. Lanken PN, Ahlheit BD, Crawford S, et al. Withholding and withdrawing life-sustaining therapy. Am Rev Respir Dis 1991; 144: 726-731.
26. Schoenenberger AW, Stortecky S, Neumann S, et al. Predictors of functional decline in elderly patients undergoing transcatheter aortic valve implantation (TAVI). Eur Heart J 2013; 34: 684-692.
27. Fried LP, Tangen CM, Walston J, et al. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci 2001; 56: M146-M156.
28. Rodes-Cabau J, Mok M. Working toward a frailty index in transcatheter aortic valve replacement: a major move away from the “eyeball test”. JACC Cardiovasc Interv 2012; 5: 982-983.
29. Kahlert P, Knipp SC, Schlamann M, et al. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation 2010; 121: 870-878.
30. Nombela-Franco L, Webb JG, de Jaegere PP, et al. Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation 2012; 126: 3041-3053.
31. Webb J, Rodes-Cabau J, Fremes S, et al. Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement. Can J Cardiol 2012; 28: 520-528.
32. Kahlert P, Al-Rashid F, Dottger P, et al. Cerebral embolization during transcatheter aortic valve implantation: a transcranial Doppler study. Circulation 2012; 126: 1245-1255.
33. Schmidt T, Akdag O, Wohlmuth P, et al. Histological findings and predictors of cerebral debris from transcatheter aortic valve replacement: the ALSTER experience. J Am Heart Assoc 2016; 5: e004399.
34. Bagur R, Solo K, Alghofaili S, et al. Cerebral embolic protection devices during transcatheter aortic valve implantation: systematic review and meta-analysis. Stroke 2017; 48: 1306-1315.
35. Haussig S, Mangner N, Dwyer MG, et al. Effect of a cerebral protection device on brain lesions following transcatheter aortic valve implantation in patients with severe aortic stenosis: the CLEAN-TAVI Randomized Clinical Trial. JAMA 2016; 316: 592-601.
36. Gerckens U, Tamburino C, Bleiziffer S, et al. Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study. Eur Heart J 2017; 38: 2729-2738.
37. Foroutan F, Guyatt GH, Otto CM, et al. Structural valve deterioration after transcatheter aortic valve implantation. Heart 2017; 103: 1899-1905.
38. Beohar N, Kirtane AJ, Blackstone E, et al. Trends in complications and outcomes of patients undergoing transfemoral transcatheter aortic valve replacement: experience from the PARTNER continued access registry. JACC Cardiovasc Interv 2016; 9: 355-363.
39. Kodali S, Pibarot P, Douglas PS, et al. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: characterizing patients and impact on outcomes. Eur Heart J 2015; 36: 449-456.
40. Athappan G, Patvardhan E, Tuzcu EM, et al. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature. J Am Coll Cardiol 2013; 61: 1585-1595.
41. Nietlispach F, Maisano F, Sorajja P, Leon MB, Rihal C, Feldman T. Percutaneous paravalvular leak closure: chasing the chameleon. Eur Heart J 2016; 37: 3495-3502.
42. Ussia GP, Barbanti M, Ramondo A, et al. The valve-in-valve technique for treatment of aortic bioprosthesis malposition an analysis of incidence and 1-year clinical outcomes from the Italian CoreValve registry. J Am Coll Cardiol 2011; 57: 1062-1068.
43. Moreno R, Dobarro D, Lopez de Sa E, et al. Cause of complete atrioventricular block after percutaneous aortic valve implantation: insights from a necropsy study. Circulation 2009; 120: e29-e30.
44. Wendler O, Schymik G, Treede H, et al. SOURCE 3 Registry: design and 30-day results of the European postapproval registry of the latest generation of the SAPIEN 3 transcatheter heart valve. Circulation 2017; 135: 1123-1132.
45. Sorajja P, Kodali S, Reardon MJ, et al. Outcomes for the commercial use of self-expanding prostheses in transcatheter aortic valve replacement: a report from the STS/ACC TVT registry. JACC Cardiovasc Interv 2017; 10: 2090-2098.
46. Hoffmann G, Lutter G, Cremer J. Durability of bioprosthetic cardiac valves. Dtsch Arztebl Int 2008; 105: 143-148.
47. Webb JG, Mack MJ, White JM, et al. Transcatheter aortic valve implantation within degenerated aortic surgical bioprostheses: PARTNER 2 Valve-in-Valve Registry. J Am Coll Cardiol 2017; 69: 2253-2262.
48. Puri R, Chamandi C, Rodriguez-Gabella T, Rodes-Cabau J. Future of transcatheter aortic valve implantation - evolving clinical indications. Nat Rev Cardiol 2018; 15: 57-65.
49. Eggebrecht H, Mehta RH. Transcatheter aortic valve implantation (TAVI) in Germany 2008–2014: on its way to standard therapy for aortic valve stenosis in the elderly? EuroIntervention 2016; 11: 1029-1033.
50. Walters DL, Webster M, Pasupati S, et al. Position statement for the operator and institutional requirements for a transcatheter aortic valve implantation (TAVI) program. Heart Lung Circ 2015; 24: 219-223.

Online responses are no longer available. Please refer to our instructions for authors page for more information.

Transcatheter aortic valve implantation: a new standard of care

Topics

Summary

Author

Comment

Do you have any competing interests to declare? *