Transcatheter Self-Expandable Valve Implantation for Aortic Stenosis in Small Aortic Annuli: The TAVI-SMALL Registry

TAVI-SMALL Investigators

doi:10.1016/j.jcin.2019.08.041

Transcatheter Self-Expandable Valve Implantation for Aortic Stenosis in Small Aortic Annuli: The TAVI-SMALL Registry

TAVI-SMALL Investigators

Research output: Contribution to journal › Article › peer-review

Abstract

OBJECTIVES: The aim of this study was to evaluate and compare the outcomes of transcatheter self-expandable prostheses in patients with small annuli.

BACKGROUND: Transcatheter aortic heart valves appear to have better performance than surgical valves in terms of prosthesis-patient mismatch, especially in patients with aortic stenosis with small aortic annuli.

METHODS: TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) is a retrospective registry of patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 on computed tomography) treated with transcatheter self-expandable valves (n = 859; Evolut R, n = 397; Evolut PRO, n = 84; ACURATE, n = 201; Portico, n = 177). Primary endpoints were post-procedural mean aortic gradient, indexed effective orifice area, and rate of severe prosthesis-patient mismatch.

RESULTS: Pre-discharge gradients were consistently low in every group, with a slight benefit with the Evolut R (8.1 mm Hg; 95% confidence interval [CI]: 7.7 to 8.5 mm Hg) and Evolut PRO (6.9 mm Hg; 95% CI: 6.3 to 7.6 mm Hg) compared with the ACURATE (9.6 mm Hg; 95% CI: 8.9 to 10.2 mm Hg) and Portico (8.9 mm Hg; 95% CI: 8.2 to 9.6 mm Hg) groups (p < 0.001). Mean indexed effective orifice area was 1.04 cm2/m2 (95% CI: 1.01 to 1.08 cm2/m2) with a trend toward lower values with the Portico. No significant differences were reported in terms of severe prosthesis-patient mismatch (overall rate 9.4%; p = 0.134), permanent pacemaker implantation (15.6%), and periprocedural and 1-year adverse events. Pre-discharge more than mild paravalvular leaks were significantly more common with the Portico (19.2%) and less common with the Evolut PRO (3.6%) compared with the Evolut R (11.8%) and ACURATE (9%) groups.

CONCLUSIONS: Transcatheter self-expandable valves showed optimal clinical and echocardiographic results in patients with small aortic annuli, although supra-annular functioning transcatheter heart valves seemed to slightly outperform intra-annular functioning ones. The role of transcatheter aortic valve replacement with self-expandable valves for the treatment of aortic stenosis in patients with small annuli needs to be confirmed in larger trials.

Original language	English
Pages (from-to)	196-206
Number of pages	11
Journal	JACC: Cardiovascular Interventions
Volume	13
Issue number	2
DOIs	https://doi.org/10.1016/j.jcin.2019.08.041
Publication status	Published - Jan 27 2020

Keywords

Aged, 80 and over
Aortic Valve/diagnostic imaging
Aortic Valve Stenosis/diagnostic imaging
Europe
Female
Heart Valve Prosthesis
Hemodynamics
Humans
Male
Postoperative Complications/etiology
Prosthesis Design
Recovery of Function
Registries
Retrospective Studies
Severity of Illness Index
Time Factors
Tomography, X-Ray Computed
Transcatheter Aortic Valve Replacement/adverse effects
Treatment Outcome

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10.1016/j.jcin.2019.08.041

Cite this

@article{ee396339ecd34a8c908fa2a0b7933755,

title = "Transcatheter Self-Expandable Valve Implantation for Aortic Stenosis in Small Aortic Annuli: The TAVI-SMALL Registry",

abstract = "OBJECTIVES: The aim of this study was to evaluate and compare the outcomes of transcatheter self-expandable prostheses in patients with small annuli.BACKGROUND: Transcatheter aortic heart valves appear to have better performance than surgical valves in terms of prosthesis-patient mismatch, especially in patients with aortic stenosis with small aortic annuli.METHODS: TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) is a retrospective registry of patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 on computed tomography) treated with transcatheter self-expandable valves (n = 859; Evolut R, n = 397; Evolut PRO, n = 84; ACURATE, n = 201; Portico, n = 177). Primary endpoints were post-procedural mean aortic gradient, indexed effective orifice area, and rate of severe prosthesis-patient mismatch.RESULTS: Pre-discharge gradients were consistently low in every group, with a slight benefit with the Evolut R (8.1 mm Hg; 95% confidence interval [CI]: 7.7 to 8.5 mm Hg) and Evolut PRO (6.9 mm Hg; 95% CI: 6.3 to 7.6 mm Hg) compared with the ACURATE (9.6 mm Hg; 95% CI: 8.9 to 10.2 mm Hg) and Portico (8.9 mm Hg; 95% CI: 8.2 to 9.6 mm Hg) groups (p < 0.001). Mean indexed effective orifice area was 1.04 cm2/m2 (95% CI: 1.01 to 1.08 cm2/m2) with a trend toward lower values with the Portico. No significant differences were reported in terms of severe prosthesis-patient mismatch (overall rate 9.4%; p = 0.134), permanent pacemaker implantation (15.6%), and periprocedural and 1-year adverse events. Pre-discharge more than mild paravalvular leaks were significantly more common with the Portico (19.2%) and less common with the Evolut PRO (3.6%) compared with the Evolut R (11.8%) and ACURATE (9%) groups.CONCLUSIONS: Transcatheter self-expandable valves showed optimal clinical and echocardiographic results in patients with small aortic annuli, although supra-annular functioning transcatheter heart valves seemed to slightly outperform intra-annular functioning ones. The role of transcatheter aortic valve replacement with self-expandable valves for the treatment of aortic stenosis in patients with small annuli needs to be confirmed in larger trials.",

keywords = "Aged, 80 and over, Aortic Valve/diagnostic imaging, Aortic Valve Stenosis/diagnostic imaging, Europe, Female, Heart Valve Prosthesis, Hemodynamics, Humans, Male, Postoperative Complications/etiology, Prosthesis Design, Recovery of Function, Registries, Retrospective Studies, Severity of Illness Index, Time Factors, Tomography, X-Ray Computed, Transcatheter Aortic Valve Replacement/adverse effects, Treatment Outcome",

author = "{TAVI-SMALL Investigators} and Damiano Regazzoli and Mauro Chiarito and Francesco Cannata and Matteo Pagnesi and Mizuki Miura and Francesca Ziviello and Andrea Picci and J{\"o}rg Reifart and {De Marco}, Federico and Francesco Bedogni and Marianna Adamo and Salvatore Curello and Rui Teles and Maurizio Taramasso and Marco Barbanti and Corrado Tamburino and Stefanini, {Giulio G} and Antonio Mangieri and Francesco Giannini and Pagnotta, {Paolo A} and Francesco Maisano and Won-Keun Kim and {Van Mieghem}, {Nicolas M} and Antonio Colombo and Bernhard Reimers and Azeem Latib",

year = "2020",

month = jan,

day = "27",

doi = "10.1016/j.jcin.2019.08.041",

language = "English",

volume = "13",

pages = "196--206",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "2",

}

TY - JOUR

T1 - Transcatheter Self-Expandable Valve Implantation for Aortic Stenosis in Small Aortic Annuli

T2 - The TAVI-SMALL Registry

AU - TAVI-SMALL Investigators

AU - Regazzoli, Damiano

AU - Chiarito, Mauro

AU - Cannata, Francesco

AU - Pagnesi, Matteo

AU - Miura, Mizuki

AU - Ziviello, Francesca

AU - Picci, Andrea

AU - Reifart, Jörg

AU - De Marco, Federico

AU - Bedogni, Francesco

AU - Adamo, Marianna

AU - Curello, Salvatore

AU - Teles, Rui

AU - Taramasso, Maurizio

AU - Barbanti, Marco

AU - Tamburino, Corrado

AU - Stefanini, Giulio G

AU - Mangieri, Antonio

AU - Giannini, Francesco

AU - Pagnotta, Paolo A

AU - Maisano, Francesco

AU - Kim, Won-Keun

AU - Van Mieghem, Nicolas M

AU - Colombo, Antonio

AU - Reimers, Bernhard

AU - Latib, Azeem

PY - 2020/1/27

Y1 - 2020/1/27

N2 - OBJECTIVES: The aim of this study was to evaluate and compare the outcomes of transcatheter self-expandable prostheses in patients with small annuli.BACKGROUND: Transcatheter aortic heart valves appear to have better performance than surgical valves in terms of prosthesis-patient mismatch, especially in patients with aortic stenosis with small aortic annuli.METHODS: TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) is a retrospective registry of patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 on computed tomography) treated with transcatheter self-expandable valves (n = 859; Evolut R, n = 397; Evolut PRO, n = 84; ACURATE, n = 201; Portico, n = 177). Primary endpoints were post-procedural mean aortic gradient, indexed effective orifice area, and rate of severe prosthesis-patient mismatch.RESULTS: Pre-discharge gradients were consistently low in every group, with a slight benefit with the Evolut R (8.1 mm Hg; 95% confidence interval [CI]: 7.7 to 8.5 mm Hg) and Evolut PRO (6.9 mm Hg; 95% CI: 6.3 to 7.6 mm Hg) compared with the ACURATE (9.6 mm Hg; 95% CI: 8.9 to 10.2 mm Hg) and Portico (8.9 mm Hg; 95% CI: 8.2 to 9.6 mm Hg) groups (p < 0.001). Mean indexed effective orifice area was 1.04 cm2/m2 (95% CI: 1.01 to 1.08 cm2/m2) with a trend toward lower values with the Portico. No significant differences were reported in terms of severe prosthesis-patient mismatch (overall rate 9.4%; p = 0.134), permanent pacemaker implantation (15.6%), and periprocedural and 1-year adverse events. Pre-discharge more than mild paravalvular leaks were significantly more common with the Portico (19.2%) and less common with the Evolut PRO (3.6%) compared with the Evolut R (11.8%) and ACURATE (9%) groups.CONCLUSIONS: Transcatheter self-expandable valves showed optimal clinical and echocardiographic results in patients with small aortic annuli, although supra-annular functioning transcatheter heart valves seemed to slightly outperform intra-annular functioning ones. The role of transcatheter aortic valve replacement with self-expandable valves for the treatment of aortic stenosis in patients with small annuli needs to be confirmed in larger trials.

AB - OBJECTIVES: The aim of this study was to evaluate and compare the outcomes of transcatheter self-expandable prostheses in patients with small annuli.BACKGROUND: Transcatheter aortic heart valves appear to have better performance than surgical valves in terms of prosthesis-patient mismatch, especially in patients with aortic stenosis with small aortic annuli.METHODS: TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) is a retrospective registry of patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 on computed tomography) treated with transcatheter self-expandable valves (n = 859; Evolut R, n = 397; Evolut PRO, n = 84; ACURATE, n = 201; Portico, n = 177). Primary endpoints were post-procedural mean aortic gradient, indexed effective orifice area, and rate of severe prosthesis-patient mismatch.RESULTS: Pre-discharge gradients were consistently low in every group, with a slight benefit with the Evolut R (8.1 mm Hg; 95% confidence interval [CI]: 7.7 to 8.5 mm Hg) and Evolut PRO (6.9 mm Hg; 95% CI: 6.3 to 7.6 mm Hg) compared with the ACURATE (9.6 mm Hg; 95% CI: 8.9 to 10.2 mm Hg) and Portico (8.9 mm Hg; 95% CI: 8.2 to 9.6 mm Hg) groups (p < 0.001). Mean indexed effective orifice area was 1.04 cm2/m2 (95% CI: 1.01 to 1.08 cm2/m2) with a trend toward lower values with the Portico. No significant differences were reported in terms of severe prosthesis-patient mismatch (overall rate 9.4%; p = 0.134), permanent pacemaker implantation (15.6%), and periprocedural and 1-year adverse events. Pre-discharge more than mild paravalvular leaks were significantly more common with the Portico (19.2%) and less common with the Evolut PRO (3.6%) compared with the Evolut R (11.8%) and ACURATE (9%) groups.CONCLUSIONS: Transcatheter self-expandable valves showed optimal clinical and echocardiographic results in patients with small aortic annuli, although supra-annular functioning transcatheter heart valves seemed to slightly outperform intra-annular functioning ones. The role of transcatheter aortic valve replacement with self-expandable valves for the treatment of aortic stenosis in patients with small annuli needs to be confirmed in larger trials.

KW - Aged, 80 and over

KW - Aortic Valve/diagnostic imaging

KW - Aortic Valve Stenosis/diagnostic imaging

KW - Europe

KW - Female

KW - Heart Valve Prosthesis

KW - Hemodynamics

KW - Humans

KW - Male

KW - Postoperative Complications/etiology

KW - Prosthesis Design

KW - Recovery of Function

KW - Registries

KW - Retrospective Studies

KW - Severity of Illness Index

KW - Time Factors

KW - Tomography, X-Ray Computed

KW - Transcatheter Aortic Valve Replacement/adverse effects

KW - Treatment Outcome

U2 - 10.1016/j.jcin.2019.08.041

DO - 10.1016/j.jcin.2019.08.041

M3 - Article

C2 - 31883714

SN - 1936-8798

VL - 13

SP - 196

EP - 206

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 2

ER -

Transcatheter Self-Expandable Valve Implantation for Aortic Stenosis in Small Aortic Annuli: The TAVI-SMALL Registry

Abstract

Keywords

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