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Published online: 2021-08-17
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Transfermoral transcatheter aortic valve implantation using self-expanding Allegra bioprosthesis: One-year single-center outcomes

Joanna Milan, Mirosław Gozdek, Radosław Targoński, Mariusz Kowalewski, Aleksandra Stańska, Marcin Fijałkowski, Romuald Lango, Miłosz Jaguszewski, Dariusz Jagielak
DOI: 10.5603/CJ.a2021.0093
·
Pubmed: 34490606

open access

Ahead of print
Original articles
Published online: 2021-08-17

Abstract

Background: The NAUTILUS study aimed to evaluate the safety and performance of the Allegra bioprosthesis in high-risk recipients undergoing transcatheter aortic valve implantation and were reported on 30-day outcomes. Hence, are the presented 1-year results of the trial.

Methods: Twenty-seven recipients with severe, symptomatic aortic valve stenosis at high surgical risk, who underwent treatment using the next-generation self-expanding Allegra via transfemoral approach were prospectively enrolled. Clinical endpoints assessed were: mortality, stroke, permanent pacemaker implantation, New York Heart Association class and re-hospitalizations. Prosthetic valve performance evaluation comprised of: mean gradient, effective orifice area and paravalvular leak.

Results: Patients were elderly (82.8 ± 4.2 years) and predominantly female (n = 19, 70.4%). All of them were deemed to be at high surgical risk with a mean logistic EuroSCORE of 12.5 ± 6.7. The bioprosthesis was successfully implanted in 92.6% of the cases (n = 25). At 1-year, all-cause mortality was 12.0% (n = 3) and stroke was 4.0% (n = 1). Three (12%) of patients developed complete atrioventricular block and received permanent pacemakers. 84% of patients were in New York Heart Association class II or lower. Need for subsequent hospitalization arose in 48% patients. The echocardiographic assessment confirmed an acceptable hemodynamic profile of the Allegra with low mean transprosthetic gradient (9.5 ± 3.4 mmHg), absence of severe paravalvular leak and a 20%-presence of moderate paravalvular leak.

Conclusions: The current follow-up observation study shows that the Allegra was associated with a satisfactory safety profile and hemodynamic performance at 1-year after implantation.

Abstract

Background: The NAUTILUS study aimed to evaluate the safety and performance of the Allegra bioprosthesis in high-risk recipients undergoing transcatheter aortic valve implantation and were reported on 30-day outcomes. Hence, are the presented 1-year results of the trial.

Methods: Twenty-seven recipients with severe, symptomatic aortic valve stenosis at high surgical risk, who underwent treatment using the next-generation self-expanding Allegra via transfemoral approach were prospectively enrolled. Clinical endpoints assessed were: mortality, stroke, permanent pacemaker implantation, New York Heart Association class and re-hospitalizations. Prosthetic valve performance evaluation comprised of: mean gradient, effective orifice area and paravalvular leak.

Results: Patients were elderly (82.8 ± 4.2 years) and predominantly female (n = 19, 70.4%). All of them were deemed to be at high surgical risk with a mean logistic EuroSCORE of 12.5 ± 6.7. The bioprosthesis was successfully implanted in 92.6% of the cases (n = 25). At 1-year, all-cause mortality was 12.0% (n = 3) and stroke was 4.0% (n = 1). Three (12%) of patients developed complete atrioventricular block and received permanent pacemakers. 84% of patients were in New York Heart Association class II or lower. Need for subsequent hospitalization arose in 48% patients. The echocardiographic assessment confirmed an acceptable hemodynamic profile of the Allegra with low mean transprosthetic gradient (9.5 ± 3.4 mmHg), absence of severe paravalvular leak and a 20%-presence of moderate paravalvular leak.

Conclusions: The current follow-up observation study shows that the Allegra was associated with a satisfactory safety profile and hemodynamic performance at 1-year after implantation.

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Keywords

Allegra, NAUTILUS clinical study, transcatheter aortic valve implantation

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Title

Transfermoral transcatheter aortic valve implantation using self-expanding Allegra bioprosthesis: One-year single-center outcomes

Journal

Cardiology Journal

Issue

Ahead of print

Article type

Original Article

Published online

2021-08-17

DOI

10.5603/CJ.a2021.0093

Pubmed

34490606

Keywords

Allegra
NAUTILUS clinical study
transcatheter aortic valve implantation

Authors

Joanna Milan
Mirosław Gozdek
Radosław Targoński
Mariusz Kowalewski
Aleksandra Stańska
Marcin Fijałkowski
Romuald Lango
Miłosz Jaguszewski
Dariusz Jagielak

References (24)
  1. 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(24): 3006–3008.
  2. Wenaweser P, Stortecky S, Schütz T, et al. Transcatheter aortic valve implantation with the NVT Allegra transcatheter heart valve system: first-in-human experience with a novel self-expanding transcatheter heart valve. EuroIntervention. 2016; 12(1): 71–77.
  3. Jagielak D, Stanska A, Klapkowski A, et al. Transfermoral aortic valve implantation using self-expanding New Valve Technology (NVT) Allegra bioprosthesis: A pilot prospective study. Cardiol J. 2021; 28(3): 384–390.
  4. Cuevas O, Moreno R, Pascual-Tejerina V, et al. The Allegra transcatheter heart valve: European multicentre experience with a novel self-expanding transcatheter aortic valve. EuroIntervention. 2019; 15(1): 71–73.
  5. Kodali S, Williams M, Smith C, et al. Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med. 2012; 366(18): 1686–1695.
  6. Jones BM, Tuzcu EM, Krishnaswamy A, et al. Prognostic significance of mild aortic regurgitation in predicting mortality after transcatheter aortic valve replacement. J Thorac Cardiovasc Surg. 2016; 152(3): 783–790.
  7. 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. 2011; 123(3): 299–308.
  8. 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(15): 1585–1595.
  9. Jones BM, Tuzcu EM, Krishnaswamy A, et al. Prognostic significance of mild aortic regurgitation in predicting mortality after transcatheter aortic valve replacement. J Thorac Cardiovasc Surg. 2016; 152(3): 783–790.
  10. Little SH, Oh JK, Gillam L, et al. Self-Expanding transcatheter aortic valve replacement versus surgical valve replacement in patients at high risk for surgery: a study of echocardiographic change and risk prediction. Circ Cardiovasc Interv. 2016; 9(6).
  11. Adams DH, Popma JJ, Reardon MJ, et al. U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014; 370(19): 1790–1798.
  12. Popma J, Adams D, Reardon M, 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(19): 1972–1981.
  13. Manoharan G, Van Mieghem NM, Windecker S, et al. 1-Year outcomes with the evolut r self-expanding transcatheter aortic valve: from the international FORWARD study. JACC Cardiovasc Interv. 2018; 11(22): 2326–2334.
  14. Mauri V, Kim WK, Abumayyaleh M, et al. Short-Term outcome and hemodynamic performance of next-generation self-expanding versus balloon-expandable transcatheter aortic valves in patients with small aortic annulus: a multicenter propensity-matched comparison. Circ Cardiovasc Interv. 2017; 10(10).
  15. Oh JK, Little SH, Abdelmoneim SS, et al. CoreValve U.S. Pivotal Trial Clinical Investigators. Regression of Paravalvular Aortic Regurgitation and Remodeling of Self-Expanding Transcatheter Aortic Valve: An Observation From the CoreValve U.S. Pivotal Trial. JACC Cardiovasc Imaging. 2015; 8(12): 1364–1375.
  16. Siontis GCM, Jüni P, Pilgrim T, et al. Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis. J Am Coll Cardiol. 2014; 64(2): 129–140.
  17. Hayashida K, Morice MC, Chevalier B, et al. Sex-related differences in clinical presentation and outcome of transcatheter aortic valve implantation for severe aortic stenosis. J Am Coll Cardiol. 2012; 59(6): 566–571.
  18. Khawaja MZ, Rajani R, Cook A, et al. Permanent pacemaker insertion after CoreValve transcatheter aortic valve implantation: incidence and contributing factors (the UK CoreValve Collaborative). Circulation. 2011; 123(9): 951–960.
  19. Buellesfeld L, Stortecky S, Heg D, et al. Impact of permanent pacemaker implantation on clinical outcome among patients undergoing transcatheter aortic valve implantation. J Am Coll Cardiol. 2012; 60(6): 493–501.
  20. Dizon JM, Nazif TM, Hess PL, et al. PARTNER Publications Office. Chronic pacing and adverse outcomes after transcatheter aortic valve implantation. Heart. 2015; 101(20): 1665–1671.
  21. Nazif TM, Dizon JM, Hahn RT, et al. Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (placement of aortic transcatheter valves) trial and registry. J Am Coll Cardiol Intv. 2015; 8: 60–69.
  22. Urena M, Webb JG, Tamburino C, et al. Permanent pacemaker implantation after transcatheter aortic valve implantation: impact on late clinical outcomes and left ventricular function. Circulation. 2014; 129(11): 1233–1243.
  23. Engborg J, Riechel-Sarup C, Gerke O, et al. Effect of permanent pacemaker on mortality after transcatheter aortic valve replacement. Scand Cardiovasc J. 2017; 51(1): 40–46.
  24. Barth S, Reents W, Zacher M, et al. Multicentre propensity-matched comparison of transcatheter aortic valve implantation using the ACURATE TA/neo self-expanding versus the SAPIEN 3 balloon-expandable prosthesis. EuroIntervention. 2019; 15(10): 884–891.

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