Early clinical and procedural outcomes in large series of 34-mm self-expanding transcatheter aortic valve replacement.
Aged
Aged, 80 and over
Aortic Valve
/ diagnostic imaging
Aortic Valve Stenosis
/ diagnostic imaging
Female
Heart Valve Prosthesis
Hospital Mortality
Humans
Male
Postoperative Complications
/ mortality
Prosthesis Design
Recovery of Function
Retrospective Studies
Risk Factors
Severity of Illness Index
Time Factors
Transcatheter Aortic Valve Replacement
/ adverse effects
Treatment Outcome
34 mm
TAVR
aortic stenosis
large annuli
paravalvular leak
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
01 10 2020
01 10 2020
Historique:
received:
06
09
2019
revised:
17
10
2019
accepted:
21
11
2019
pubmed:
5
12
2019
medline:
8
6
2021
entrez:
5
12
2019
Statut:
ppublish
Résumé
We aimed to evaluate early clinical and procedural outcomes with the 34-mm Evolut R transcatheter aortic valve replacement (TAVR) prosthesis. The 34-mm Evolut R (Medtronic, Minneapolis, MN) self-expanding TAVR prosthesis was designed to treat patients with larger annuli. Clinical, demographic, procedural, and echocardiographic data on consecutive patients who underwent TAVR with a 34-mm Evolut R prosthesis at our institution were collected and analyzed. One hundred ninety-six patients underwent TAVR with this prosthesis from November 2016 to July 2018, a majority (n = 188, 96%) through transfemoral access and with conscious sedation (n = 182, 93%). Mean age, Society of Thoracic Surgery risk score, and follow-up were 82 ± 8 years, 5.4 ± 5%, and 8.2 ± 5.3 months, respectively. Mean aortic valve (AV) peak velocity was 4.0 ± 0.6 m/s, mean AV gradient was 38 ± 13 mmHg, AV area was 0.79 ± 0.23 cm These data demonstrate high success and good procedural, echocardiographic, and clinical outcomes of 34-mm Evolut R in patients with large annuli.
Sections du résumé
OBJECTIVES
We aimed to evaluate early clinical and procedural outcomes with the 34-mm Evolut R transcatheter aortic valve replacement (TAVR) prosthesis.
BACKGROUND
The 34-mm Evolut R (Medtronic, Minneapolis, MN) self-expanding TAVR prosthesis was designed to treat patients with larger annuli.
METHODS
Clinical, demographic, procedural, and echocardiographic data on consecutive patients who underwent TAVR with a 34-mm Evolut R prosthesis at our institution were collected and analyzed.
RESULTS
One hundred ninety-six patients underwent TAVR with this prosthesis from November 2016 to July 2018, a majority (n = 188, 96%) through transfemoral access and with conscious sedation (n = 182, 93%). Mean age, Society of Thoracic Surgery risk score, and follow-up were 82 ± 8 years, 5.4 ± 5%, and 8.2 ± 5.3 months, respectively. Mean aortic valve (AV) peak velocity was 4.0 ± 0.6 m/s, mean AV gradient was 38 ± 13 mmHg, AV area was 0.79 ± 0.23 cm
CONCLUSION
These data demonstrate high success and good procedural, echocardiographic, and clinical outcomes of 34-mm Evolut R in patients with large annuli.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
940-946Informations de copyright
© 2019 Wiley Periodicals, Inc.
Références
Stewart BF, Siscovick D, Lind BK, et al. Clinical factors associated with calcific aortic valve disease. Cardiovascular Health Study. J Am Coll Cardiol. 1997;29:630-634.
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.
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. J Am Coll Cardiol. 2017;70:252-289.
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.
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.
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.
Adams DH, Popma JJ, Reardon MJ. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;371:967-968.
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.
Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380:1695-1705.
Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 2019;380:1706-1715.
D'Agostino RS, Jacobs JP, Badhwar V, et al. The Society of Thoracic Surgeons Adult Cardiac Surgery Database: 2019 update on outcomes and quality. Ann Thorac Surg. 2019;107:24-32.
Chamandi C, Puri R, Rodriguez-Gabella T, Rodes-Cabau J. Latest-generation transcatheter aortic valve replacement devices and procedures. Can J Cardiol. 2017;33:1082-1090.
Popma JJ, Gleason TG, Yakubov SJ, et al. Relationship of annular sizing using multidetector computed tomographic imaging and clinical outcomes after self-expanding CoreValve transcatheter aortic valve replacement. Circ Cardiovasc Interv. 2016;9:e003282.
Willson AB, Webb JG, Labounty TM, et al. 3-dimensional aortic annular assessment by multidetector computed tomography predicts moderate or severe paravalvular regurgitation after transcatheter aortic valve replacement: a multicenter retrospective analysis. J Am Coll Cardiol. 2012;59:1287-1294.
Jilaihawi H, Kashif M, Fontana G, et al. Cross-sectional computed tomographic assessment improves accuracy of aortic annular sizing for transcatheter aortic valve replacement and reduces the incidence of paravalvular aortic regurgitation. J Am Coll Cardiol. 2012;59:1275-1286.
Sideris K, Deutsch M, Giambuzzi I, Lange R, Bleiziffer S. TAVI in patients with large aortic annulus: first clinical experience with a new self-expandable prosthesis. Thorac Cardiovasc Surg. 2018;66:S1-S110.
Elmously A, Worku B, Wong SC, Salemi A. Pushing boundaries: implantation of the 34 mm Medtronic CoreValve in patients with a large aortic annulus. Catheter Cardiovasc Interv. 2018;92:1449-1452.
D'Ancona G, Biondo D, Mamone G, et al. Ischemic mitral valve regurgitation in patients with depressed ventricular function: cardiac geometrical and myocardial perfusion evaluation with magnetic resonance imaging. Eur J Cardiothorac Surg. 2008;34:964-968.
Kappetein AP, Head SJ, Genereux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012;42:S45-S60.
Manoharan G, Walton AS, Brecker SJ, et al. Treatment of symptomatic severe aortic stenosis with a novel resheathable supra-annular self-expanding transcatheter aortic valve system. JACC Cardiovasc Interv. 2015;8:1359-1367.
Popma JJ, Reardon MJ, Khabbaz K, et al. Early clinical outcomes after transcatheter aortic valve replacement using a novel self-expanding bioprosthesis in patients with severe aortic stenosis who are suboptimal for surgery: results of the Evolut R U.S. study. JACC Cardiovasc Interv. 2017;10:268-275.
Meredith IT, Walters DL, Dumonteil N, et al. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study. J Am Coll Cardiol. 2014;64:1339-1348.
Webb J, Gerosa G, Lefevre T, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014;64:2235-2243.
Dowling C, Firoozi S, Doyle N, et al. Initial experience of a large, self-expanding, and fully recapturable transcatheter aortic valve: the UK& Ireland Implanters' registry. Catheter Cardiovasc Interv. 2019;93:751-757.
Kalogeras K, Kabir T, Mittal T, et al. Real-world comparison of the new 34 mm self-expandable transcatheter aortic prosthesis Evolut R to its 31 mm core valve predecessor. Catheter Cardiovasc Interv. 2019;93:685-691.
Kuhn C, Frerker C, Meyer AK, et al. Transcatheter aortic valve implantation with the 34 mm self-expanding CoreValve Evolut R: initial experience in 101 patients from a multicentre registry. EuroIntervention. 2018;14:e301-e305.
Harnath A, Gomes B, Herwig V, et al. First experience with the 34 mm self-expanding Evolut R in a multicentre registry. EuroIntervention. 2018;14:e298-e300.
Petronio AS, Zucchelli G, Kovac J, de Jaegere P. ADVANCE II: best practices investigation in patients undergoing transcatheter aortic valve implantation with a self-expanding valve. Paper presented at: EuroPCR; May 20-23, 2014; Paris, France.
Nijhoff F, Agostoni P, Amrane H, Latib A, Testa L, Oreglia JA, De Marco F, Samim M, Bedogni F, Maisano F, Bruschi G, Colombo A, Van Boven AJ, Stella PR. Transcatheter aortic valve implantation in patients with severe aortic valve stenosis and large aortic annulus, using the self-expanding 31-mm Medtronic CoreValve prosthesis: first clinical experience. J Thorac Cardiovasc Surg 2014;148:492-499.