Abstract
Transcatheter aortic valve replacement (TAVR) was initially envisioned as a less invasive
option for patients with severe symptomatic aortic stenosis who either were not candidates
or were very high-risk candidates for surgical aortic valve replacement (SAVR). Based
on data from the original Placement of Aortic Transcatheter Valve (PARTNER) trials as well as the CoreValve Pivotal trials, TAVR is now approved
and accepted in the treatment of severe symptomatic aortic stenosis in extreme-risk
and high-risk patient populations. Thus far, the randomized controlled trial data
for TAVR have been noninferior or even superior to both medical therapy and SAVR.
Recently, the US Food and Drug Administration expanded the indications for 2 balloon-expandable
devices, and CE Mark status was awarded to a self-expanding device for use in patients
at intermediate risk. Given all the data, the logical next step is to study low-risk
patient groups. Anecdotal and nonrandomized data have been conflicting when comparing
TAVR to SAVR in low-risk patients. Two low-risk randomized trials have started in
the United States, and ultimately these trials will determine the feasibility of TAVR
as an acceptable alternative to SAVR in low-risk patients with severe aortic stenosis.
Résumé
Le remplacement valvulaire aortique par cathéter (RVAC) était au départ perçu comme
une option moins invasive pour les patients atteints d'une sténose aortique symptomatique
grave qui n’étaient pas des candidats ou qui étaient des candidats exposés à un risque
très élevé de chirurgie de remplacement valvulaire aortique (CRVA). Selon les données
des études originales PARTNER (Placement of Aortic Transcatheter Valves) et des études pivots CoreValve, le RVAC est maintenant approuvé et accepté
pour le traitement de la sténose aortique symptomatique grave chez les populations
de patients exposés à un risque extrême et à un risque élevé. Jusqu’à maintenant,
les données de l'essai clinique à répartition aléatoire sur le RVAC n'ont pas montré
de résultats inférieurs, mais plutôt des résultats supérieurs au traitement médical
et à la CRVA. Récemment, le US Food and Drug Administration (Secrétariat américain
aux produits alimentaires et pharmaceutiques) a élargi les indications de 2 dispositifs
à ballonnet gonflable. Ainsi, un dispositif à ballonnet autogonflable pour utilisation
chez les patients exposés à un risque intermédiaire a obtenu le marquage CE. À la
lumière de toutes ces données, l’étape logique suivante consiste à étudier les groupes
de patients exposés à un risque faible. Les données empiriques et non aléatoires étaient
contradictoires lorsqu'on comparait le RVAC à la CRVA chez les patients exposés à
un risque faible. Deux essais à répartition aléatoire auprès de patients exposés à
un risque faible sont en cours aux États-Unis. Ultimement, ils détermineront si le
RVAC peut s'avérer une solution de rechange acceptable à la CRVA chez les patients
atteints d'une sténose aortique grave qui sont exposés à un risque faible.
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Canadian Journal of CardiologyAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Transcatheter or surgical aortic valve replacement in patients with prior coronary artery bypass grafting.Ann Thorac Surg. 2016; 101: 72-79
- 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.Circulation. 2014; 129: 2440-2492
- Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery?.Eur Heart J. 2005; 26: 2714-2720
- Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis.Ann Thorac Surg. 2006; 82: 2111-2115
- Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: the potential role of subjectively overestimated operative risk.Circ Cardiovasc Qual Outcomes. 2009; 2: 533-539
- Transcatheter aortic valve implantation: current and evolving indications.Can J Cardiol. 2016; 32: 266-269
- Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.N Engl J Med. 2010; 363: 597-607
- Transcatheter aortic-valve replacement for inoperable severe aortic stenosis.N Engl J Med. 2012; 366: 1696-1704
- Long-term outcomes of inoperable patients with aortic stenosis randomly assigned to transcatheter aortic valve replacement or standard therapy.Circulation. 2014; 130: 1483-1492
- Transcatheter versus surgical aortic-valve replacement in high-risk patients.N Engl J Med. 2011; 364: 2187-2198
- 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
- Transcatheter aortic-valve replacement with a self- expanding prosthesis.N Engl J Med. 2014; 370: 1790-1798
- Transcatheter vs. surgical aortic valve replacement in intermediate-surgical-risk patients with aortic stenosis: a propensity score- matched case-control study.Am Heart J. 2012; 164: 910-917
- Transcatheter or Surgical aortic-valve replacement in intermediate-risk patients.N Engl J Med. 2016; 374: 1609-1620
- Surgical or transcatheter aortic-valve replacement in intermediate-risk patients.N Engl J Med. 2017; 376: 1321-1331
- Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1-year results from the all-comers NOTION randomized clinical trial.J Am Coll Cardiol. 2015; 65: 2184-2194
- 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
- 2-year outcomes after iliofemoral self-expanding transcatheter aortic valve replacement in patients with severe aortic stenosis deemed extreme risk for surgery.J Am Coll Cardiol. 2015; 66: 1327-1334
- 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
- 2-year outcomes in patients undergoing surgical or self-expanding transcatheter aortic valve replacement.J Am Coll Cardiol. 2015; 66: 113-121
- 3-year outcomes in high-risk patients who underwent surgical or transcatheter aortic valve replacement.J Am Coll Cardiol. 2016; 67: 2565-2574
- A 3-center comparison of 1-year mortality outcomes between transcatheter aortic valve implantation and surgical aortic valve replacement on the basis of propensity score matching among intermediate- risk surgical patients.JACC Cardiovasc Interv. 2013; 6: 443-451
- Transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis: results from an Intermediate risk propensity-matched population of the Italian OBSERVANT study.Int J Cardiol. 2013; 167: 7945-7952
- Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis.Lancet. 2016; 387: 2218-2225
- Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants.Ann Thorac Surg. 2015; 99: 1239-1247
Article info
Publication history
Published online: June 26, 2017
Accepted:
June 23,
2017
Received:
January 17,
2017
Footnotes
See page 1128 for disclosure information.
Identification
Copyright
© 2017 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
