Abstract
Background
Despite previously described feasibility, direct transcatheter aortic valve implantation
(TAVI) with the Edwards SAPIEN S3 device (S3-THV) (Edwards Lifesciences, Irvine, CA)
has not been compared with either a systematic or a selective predilation approach.
Methods
Patients undergoing predilation were divided into a systematic group (regardless of
anatomic features) and a selective group (in the context of high valvular calcium
burden). Both groups were matched in a 2:1 fashion to patients who underwent direct
TAVI. Outcomes were assessed according to Valve Academic Research Consortium 2 (VARC-2)
criteria.
Results
Two hundred eighty-one patients underwent TAVI with the S3-THV in our centre. Of these
patients, 58 underwent predilation before device implantation (systematic, n = 26;
selective, n = 32). Procedural success was achieved in all patients. Patients in the
selective predilation group had severe valve calcification volume—more than double
that of the systematic group (445 ± 306 mm3 vs 970 ± 578 mm3, respectively; P < 0.0001).
There was a trend for less dilation after the procedure in the systematic group compared
with the selective group (4% vs 19%, respectively; P = 0.09). Device malposition necessitating a second device to be implanted occurred
in 3 cases of direct TAVI (5%) and in none of the patients undergoing predilation
(P = not significant). Thirty-day and 1-year mortality rates were similar between the
patients who underwent direct TAVI and their predilation counterparts.
Conclusions
In patients with a moderate aortic valve calcification burden, direct TAVI appears
to be feasible and safe. In those with high calcium burden, predilation should be
considered after taking into account individual risk profiles.
Résumé
Introduction
En dépit de la faisabilité précédemment décrite, le remplacement valvulaire aortique
par cathéter (TAVI) direct, par dispositif Edwards SAPIEN S3 (S3-THV) (Edwards Lifesciences,
Irvine, CA), n'a été comparée ni selon une approche de prédilatation systématique
ni selon une approche de prédilatation sélective.
Méthodes
Les patients subissant une prédilatation étaient divisés en un groupe d'approche systématique
(indépendamment des caractéristiques anatomiques) et en un groupe d'approche sélective
(dans le contexte d'un fardeau de calcification valvulaire élevé). Les deux groupes
étaient appariés 2:1 aux patients qui subissaient le TAVI directe. Les résultats cliniques
étaient évalués selon les critères du Valve Academic Research Consortium 2 (VARC-2).
Résultats
Dans notre centre, 281 patients ont subi le TAVI par S3-THV. Parmi ces patients, 58
ont subi une prédilatation avant l'implantation du dispositif (systématique, n = 26;
sélective, n = 32). Tous les patients ont subi l'intervention avec succès. Les patients
du groupe de prédilatation sélective ont montré un volume de calcification valvulaire
sévère, soit plus du double que le groupe de prédilatation systématique (445 ± 306
mm3 vs 970 ± 578 mm3, respectivement; P < 0,0001).
Une tendance à moins de post-dilatation a été observée dans le groupe de l'approche
systématique comparativement au groupe de l'approche sélective (4 % vs 19 %, respectivement; P = 0,09). Une malposition du dispositif exigeant l'implantation d'un deuxième dispositif
est survenue dans les 3 cas de TAVI direct (5 %) et chez aucun des patients ayant
subi une prédilatation (P = non significatif). Les taux de mortalité à 30 jours et à 1 an étaient similaires
entre les patients qui subissaient le TAVI directe et ceux qui subissaient une prédilatation.
Conclusions
Chez les patients ayant un fardeau de calcification valvulaire aortique modéré, le
TAVI direct semble être réalisable et sécuritaire Chez ceux ayant un fardeau de calcification
valvulaire élevé, une prédilatation peut être envisagée après avoir tenu compte des
profils individuels de risque.
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 aortic-valve replacement for inoperable severe aortic stenosis.N Engl J Med. 2012; 366: 1696-1704
- One year follow-up of the multi-centre European PARTNER transcatheter heart valve study.Eur Heart J. 2011; 32: 148-157
- One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.Circulation. 2011; 124: 425-433
- Two-year outcomes after transcatheter or surgical aortic-valve replacement.N Engl J Med. 2012; 366: 1686-1695
- Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a weighted meta-analysis of 3,519 patients from 16 studies.J Am Coll Cardiol. 2012; 59: 2317-2326
- 5-year outcome after transcatheter aortic valve implantation.J Am Coll Cardiol. 2013; 61: 413-419
- 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
- Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis.Lancet. 2016; 387: 2218-2225
- Transcatheter or surgical aortic-valve replacement in intermediate-risk patients.N Engl J Med. 2016; 374: 1609-1620
- Complications of transcatheter aortic valve implantation (TAVI): how to avoid and treat them.Heart. 2015; 101: 900-908
- Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.N Engl J Med. 2010; 363: 1597-1607
- Feasibility of transcatheter aortic valve implantation without balloon pre-dilation: a pilot study.JACC Cardiovasc Interv. 2011; 4: 751-757
- Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study.Circulation. 2010; 121: 870-878
- Imaging and functional testing to assess clinical and subclinical neurological events after transcatheter or surgical aortic valve replacement: a comprehensive review.J Am Coll Cardiol. 2014; 64: 1950-1963
- Electrocardiographic and further predictors for permanent pacemaker requirement after transcatheter aortic valve implantation.Europace. 2010; 12: 1188-1190
- Edwards SAPIEN 3 valve.EuroIntervention. 2012; 8: Q83-Q87
- Impact of rapid ventricular pacing during TAVI on microvascular tissue perfusion.Clin Res Cardiol. 2014; 103: 902-911
- Transfemoral aortic valve implantation of Edwards SAPIEN XT without predilatation is feasible.Clin Cardiol. 2014; 37: 667-671
Kim WK, Praz F, Blumenstein J, et al. Transfemoral aortic valve implantation of Edwards SAPIEN 3 without predilatation [e-pub ahead of print]. Catheter Cardiovasc Interv doi: 10.1002/ccd.26464. Accessed August 1, 2016.
- Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice.Eur J Echocardiogr. 2009; 10: 1-25
- A revised methodology for aortic-valvar complex calcium quantification for transcatheter aortic valve implantation.Eur Heart J Cardiovasc Imaging. 2014; 15: 1324-1332
- Aortic annulus dimensions and leaflet calcification from contrast MSCT predict the need for balloon dilation after the procedure after TAVI with the Medtronic CoreValve prosthesis.EuroIntervention. 2011; 7: 564-572
- Association of aortic valve calcification severity with the degree of aortic regurgitation after transcatheter aortic valve implantation.Int J Cardiol. 2011; 150: 142-145
- Location and severity of aortic valve calcium and implications for aortic regurgitation after transcatheter aortic valve implantation.Am J Cardiol. 2011; 108: 1470-1477
- A new transcatheter aortic valve and percutaneous valve delivery system.J Am Coll Cardiol. 2009; 53: 1855-1858
- Transaortic transcatheter aortic valve implantation: step-by-step guide.Semin Thorac Cardiovasc Surg. 2012; 24: 206-211
- Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.J Thorac Cardiovasc Surg. 2013; 145: 6-23
- Registry of transcatheter aortic-valve implantation in high-risk patients.N Engl J Med. 2012; 366: 1705-1715
- Feasibility and safety of balloon-expandable transcatheter aortic valve implantation with moderate or without predilatation.EuroIntervention. 2016; 11: 1132-1139
- Direct transcatheter aortic valve implantation with self-expandable bioprosthesis: feasibility and safety.Cardiovasc Revasc Med. 2014; 15: 200-203
- Paravalvular regurgitation after transcatheter aortic valve replacement: diagnosis, clinical outcome, preventive and therapeutic strategies.Cardiovasc Revasc Med. 2013; 14: 174-181
- Outcomes after transcatheter aortic valve replacement using a novel balloon-expandable transcatheter heart valve: a single-center experience.JACC Cardiovasc Interv. 2015; 8: 1809-1816
- Procedural results and clinical outcomes of transcatheter aortic valve implantation in Switzerland: an observational cohort study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves.Circ Cardiovasc Interv. 2015; 8: 10
- Transcatheter aortic valve implantation with the new balloon-expandable Sapien 3 versus Sapien XT valve system: a propensity score-matched single-center comparison.Circ Cardiovasc Interv. 2015; 8: e002408
- Stroke after transcatheter aortic valve replacement: incidence, risk factors, prognosis, and preventive strategies.Clin Cardiol. 2014; 37: 756-764
- Paravalvular leak after transcatheter aortic valve replacement.Minerva Cardioangiol. 2013; 61: 529-537
- Clinical impact of aortic regurgitation after transcatheter aortic valve replacement: insights into the degree and acuteness of presentation.JACC Cardiovasc Interv. 2014; 7: 1022-1032
- Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve.J Am Coll Cardiol. 2014; 64: 2235-2243
- Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve.JACC Cardiovasc Interv. 2013; 6: 293-300
- Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve.EuroIntervention. 2015; 11: 343-350
- Permanent pacemaker insertion after CoreValve transcatheter aortic valve implantation: incidence and contributing factors (the UK CoreValve Collaborative).Circulation. 2011; 123: 951-960
- Balloon-expandable transcatheter aortic valve replacement in patients with extreme aortic valve calcification.Catheter Cardiovasc Interv. 2016; 87: 1173-1179
- Balloon expandable transcatheter aortic valve implantation with or without pre-dilation of the aortic valve—rationale and design of a multicenter registry (EASE-IT).BMC Cardiovasc Disord. 2014; 14: 160
Article info
Publication history
Published online: October 04, 2016
Accepted:
September 6,
2016
Received:
May 26,
2016
Footnotes
See page 267 for disclosure information.
Identification
Copyright
© 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
