Outcomes from Transcatheter Aortic Valve Replacement in Patients with Low-Flow, Low-Gradient Aortic Stenosis and Left Ventricular Ejection Fraction Less Than 30%: A Substudy from the TOPAS-TAVI Registry

Frédéric Maes, Stamatios Lerakis, Henrique Barbosa Ribeiro, Martine Gilard, João L. Cavalcante, Raj Makkar, Howard C. Herrmann, Stephan Windecker, Maurice E Sarano, Asim N. Cheema, Luis Nombela-Franco, Ignacio Amat-Santos, Antonio J. Muñoz-García, Bruno Garcia Del Blanco, Alan Zajarias, John C. Lisko, Salim Hayek, Vasilis Babaliaros, Florent Le Ven, Thomas G. GleasonTarun Chakravarty, Wilson Szeto, Marie Annick Clavel, Alberto De Agustin, Vicenç Serra, John T. Schindler, Abdellaziz Dahou, Mohammed Salah-Annabi, Emilie Pelletier-Beaumont, Melanie Côté, Rishi Puri, Philippe Pibarot, Josep Rodés-Cabau

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Importance: In low-flow, low-gradient aortic stenosis (LFLG AS), the severity of left ventricular dysfunction remains a key factor in the evaluation of aortic valve replacement. Objective: To evaluate the clinical outcomes and changes in left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR) in patients with LFLG AS and severe left ventricular dysfunction. Design, Setting, and Participants: This multicenter registry is a substudy of the True or Pseudo-Severe Aortic Stenosis-TAVI registry that included patients with classic LFLG AS, defined as a mean transvalvular gradient less than 35 mm Hg, an effective orifice area less than 1.0 cm2, and an LVEF of 40% or less. Patients were divided in groups with very low (<30%) LVEF and low (30%-40%) LVEF. Dobutamine stress echocardiography (DSE) was performed before TAVR in a subset with very low LVEF, and presence of contractile reserve was defined as an increase of 20% or more in stroke volume. Clinical outcomes were assessed at 1 and 12 months and yearly thereafter, and echocardiography was performed at 1-year follow-up. Retrospective data were collected from 2007 to 2013 and prospective data from January 2013 to March 2018. Data were analyzed from March to October 2018. Exposures: Transcatheter aortic valve replacement in patients with LFLG AS. Main Outcomes and Measures: Changes in LVEF over time; periprocedural and late mortality. Results: A total of 293 patients were included, including 128 (43.7%) with very low LVEF and 165 with low LVEF (56.3%). Their mean (SD) age was 80 (7) years, and most (214 [73.0%]) were men. The mean (SD) LVEF in the very low LVEF group was 22% (5%), compared with 37% (7%) in the low LVEF group (P <.001). There were no differences between groups in rates of periprocedural mortality and late mortality (median [interquartile range], 23 [6-38] months). Patients with very low LVEF displayed a greater increase in LVEF at the 1-year follow-up examination (mean absolute increase, 11.9% [95% CI, 8.8%-15.1%]), than the low LVEF group (3.6% [95% CI, 1.1%-6.1%]; P <.001). In 92 patients with very low LVEF who had preprocedural DSE, results showed a lack of contractile reserve in 45 (49%), but this had no effect on clinical outcomes or changes in LVEF over time. Conclusions and Relevance: In patients with LFLG AS and severe left ventricular dysfunction, TAVR was associated with similar clinical outcomes as in counterparts with milder left ventricular dysfunction. The TAVR procedure was associated with a significant increase in LVEF, irrespective of contractile reserve. These results support TAVR for LFLG AS, irrespective of the severity of left ventricular dysfunction and DSE results.

Original languageEnglish (US)
Pages (from-to)64-70
Number of pages7
JournalJAMA Cardiology
Volume4
Issue number1
DOIs
StatePublished - Jan 1 2019

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Aortic Valve Stenosis
Stroke Volume
Registries
Left Ventricular Dysfunction
Stress Echocardiography
Transcatheter Aortic Valve Replacement
Mortality

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Outcomes from Transcatheter Aortic Valve Replacement in Patients with Low-Flow, Low-Gradient Aortic Stenosis and Left Ventricular Ejection Fraction Less Than 30% : A Substudy from the TOPAS-TAVI Registry. / Maes, Frédéric; Lerakis, Stamatios; Barbosa Ribeiro, Henrique; Gilard, Martine; Cavalcante, João L.; Makkar, Raj; Herrmann, Howard C.; Windecker, Stephan; Sarano, Maurice E; Cheema, Asim N.; Nombela-Franco, Luis; Amat-Santos, Ignacio; Muñoz-García, Antonio J.; Garcia Del Blanco, Bruno; Zajarias, Alan; Lisko, John C.; Hayek, Salim; Babaliaros, Vasilis; Le Ven, Florent; Gleason, Thomas G.; Chakravarty, Tarun; Szeto, Wilson; Clavel, Marie Annick; De Agustin, Alberto; Serra, Vicenç; Schindler, John T.; Dahou, Abdellaziz; Salah-Annabi, Mohammed; Pelletier-Beaumont, Emilie; Côté, Melanie; Puri, Rishi; Pibarot, Philippe; Rodés-Cabau, Josep.

In: JAMA Cardiology, Vol. 4, No. 1, 01.01.2019, p. 64-70.

Research output: Contribution to journalArticle

Maes, F, Lerakis, S, Barbosa Ribeiro, H, Gilard, M, Cavalcante, JL, Makkar, R, Herrmann, HC, Windecker, S, Sarano, ME, Cheema, AN, Nombela-Franco, L, Amat-Santos, I, Muñoz-García, AJ, Garcia Del Blanco, B, Zajarias, A, Lisko, JC, Hayek, S, Babaliaros, V, Le Ven, F, Gleason, TG, Chakravarty, T, Szeto, W, Clavel, MA, De Agustin, A, Serra, V, Schindler, JT, Dahou, A, Salah-Annabi, M, Pelletier-Beaumont, E, Côté, M, Puri, R, Pibarot, P & Rodés-Cabau, J 2019, 'Outcomes from Transcatheter Aortic Valve Replacement in Patients with Low-Flow, Low-Gradient Aortic Stenosis and Left Ventricular Ejection Fraction Less Than 30%: A Substudy from the TOPAS-TAVI Registry', JAMA Cardiology, vol. 4, no. 1, pp. 64-70. https://doi.org/10.1001/jamacardio.2018.4320
Maes, Frédéric ; Lerakis, Stamatios ; Barbosa Ribeiro, Henrique ; Gilard, Martine ; Cavalcante, João L. ; Makkar, Raj ; Herrmann, Howard C. ; Windecker, Stephan ; Sarano, Maurice E ; Cheema, Asim N. ; Nombela-Franco, Luis ; Amat-Santos, Ignacio ; Muñoz-García, Antonio J. ; Garcia Del Blanco, Bruno ; Zajarias, Alan ; Lisko, John C. ; Hayek, Salim ; Babaliaros, Vasilis ; Le Ven, Florent ; Gleason, Thomas G. ; Chakravarty, Tarun ; Szeto, Wilson ; Clavel, Marie Annick ; De Agustin, Alberto ; Serra, Vicenç ; Schindler, John T. ; Dahou, Abdellaziz ; Salah-Annabi, Mohammed ; Pelletier-Beaumont, Emilie ; Côté, Melanie ; Puri, Rishi ; Pibarot, Philippe ; Rodés-Cabau, Josep. / Outcomes from Transcatheter Aortic Valve Replacement in Patients with Low-Flow, Low-Gradient Aortic Stenosis and Left Ventricular Ejection Fraction Less Than 30% : A Substudy from the TOPAS-TAVI Registry. In: JAMA Cardiology. 2019 ; Vol. 4, No. 1. pp. 64-70.
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abstract = "Importance: In low-flow, low-gradient aortic stenosis (LFLG AS), the severity of left ventricular dysfunction remains a key factor in the evaluation of aortic valve replacement. Objective: To evaluate the clinical outcomes and changes in left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR) in patients with LFLG AS and severe left ventricular dysfunction. Design, Setting, and Participants: This multicenter registry is a substudy of the True or Pseudo-Severe Aortic Stenosis-TAVI registry that included patients with classic LFLG AS, defined as a mean transvalvular gradient less than 35 mm Hg, an effective orifice area less than 1.0 cm2, and an LVEF of 40{\%} or less. Patients were divided in groups with very low (<30{\%}) LVEF and low (30{\%}-40{\%}) LVEF. Dobutamine stress echocardiography (DSE) was performed before TAVR in a subset with very low LVEF, and presence of contractile reserve was defined as an increase of 20{\%} or more in stroke volume. Clinical outcomes were assessed at 1 and 12 months and yearly thereafter, and echocardiography was performed at 1-year follow-up. Retrospective data were collected from 2007 to 2013 and prospective data from January 2013 to March 2018. Data were analyzed from March to October 2018. Exposures: Transcatheter aortic valve replacement in patients with LFLG AS. Main Outcomes and Measures: Changes in LVEF over time; periprocedural and late mortality. Results: A total of 293 patients were included, including 128 (43.7{\%}) with very low LVEF and 165 with low LVEF (56.3{\%}). Their mean (SD) age was 80 (7) years, and most (214 [73.0{\%}]) were men. The mean (SD) LVEF in the very low LVEF group was 22{\%} (5{\%}), compared with 37{\%} (7{\%}) in the low LVEF group (P <.001). There were no differences between groups in rates of periprocedural mortality and late mortality (median [interquartile range], 23 [6-38] months). Patients with very low LVEF displayed a greater increase in LVEF at the 1-year follow-up examination (mean absolute increase, 11.9{\%} [95{\%} CI, 8.8{\%}-15.1{\%}]), than the low LVEF group (3.6{\%} [95{\%} CI, 1.1{\%}-6.1{\%}]; P <.001). In 92 patients with very low LVEF who had preprocedural DSE, results showed a lack of contractile reserve in 45 (49{\%}), but this had no effect on clinical outcomes or changes in LVEF over time. Conclusions and Relevance: In patients with LFLG AS and severe left ventricular dysfunction, TAVR was associated with similar clinical outcomes as in counterparts with milder left ventricular dysfunction. The TAVR procedure was associated with a significant increase in LVEF, irrespective of contractile reserve. These results support TAVR for LFLG AS, irrespective of the severity of left ventricular dysfunction and DSE results.",
author = "Fr{\'e}d{\'e}ric Maes and Stamatios Lerakis and {Barbosa Ribeiro}, Henrique and Martine Gilard and Cavalcante, {Jo{\~a}o L.} and Raj Makkar and Herrmann, {Howard C.} and Stephan Windecker and Sarano, {Maurice E} and Cheema, {Asim N.} and Luis Nombela-Franco and Ignacio Amat-Santos and Mu{\~n}oz-Garc{\'i}a, {Antonio J.} and {Garcia Del Blanco}, Bruno and Alan Zajarias and Lisko, {John C.} and Salim Hayek and Vasilis Babaliaros and {Le Ven}, Florent and Gleason, {Thomas G.} and Tarun Chakravarty and Wilson Szeto and Clavel, {Marie Annick} and {De Agustin}, Alberto and Vicen{\cc} Serra and Schindler, {John T.} and Abdellaziz Dahou and Mohammed Salah-Annabi and Emilie Pelletier-Beaumont and Melanie C{\^o}t{\'e} and Rishi Puri and Philippe Pibarot and Josep Rod{\'e}s-Cabau",
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month = "1",
day = "1",
doi = "10.1001/jamacardio.2018.4320",
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TY - JOUR

T1 - Outcomes from Transcatheter Aortic Valve Replacement in Patients with Low-Flow, Low-Gradient Aortic Stenosis and Left Ventricular Ejection Fraction Less Than 30%

T2 - A Substudy from the TOPAS-TAVI Registry

AU - Maes, Frédéric

AU - Lerakis, Stamatios

AU - Barbosa Ribeiro, Henrique

AU - Gilard, Martine

AU - Cavalcante, João L.

AU - Makkar, Raj

AU - Herrmann, Howard C.

AU - Windecker, Stephan

AU - Sarano, Maurice E

AU - Cheema, Asim N.

AU - Nombela-Franco, Luis

AU - Amat-Santos, Ignacio

AU - Muñoz-García, Antonio J.

AU - Garcia Del Blanco, Bruno

AU - Zajarias, Alan

AU - Lisko, John C.

AU - Hayek, Salim

AU - Babaliaros, Vasilis

AU - Le Ven, Florent

AU - Gleason, Thomas G.

AU - Chakravarty, Tarun

AU - Szeto, Wilson

AU - Clavel, Marie Annick

AU - De Agustin, Alberto

AU - Serra, Vicenç

AU - Schindler, John T.

AU - Dahou, Abdellaziz

AU - Salah-Annabi, Mohammed

AU - Pelletier-Beaumont, Emilie

AU - Côté, Melanie

AU - Puri, Rishi

AU - Pibarot, Philippe

AU - Rodés-Cabau, Josep

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Importance: In low-flow, low-gradient aortic stenosis (LFLG AS), the severity of left ventricular dysfunction remains a key factor in the evaluation of aortic valve replacement. Objective: To evaluate the clinical outcomes and changes in left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR) in patients with LFLG AS and severe left ventricular dysfunction. Design, Setting, and Participants: This multicenter registry is a substudy of the True or Pseudo-Severe Aortic Stenosis-TAVI registry that included patients with classic LFLG AS, defined as a mean transvalvular gradient less than 35 mm Hg, an effective orifice area less than 1.0 cm2, and an LVEF of 40% or less. Patients were divided in groups with very low (<30%) LVEF and low (30%-40%) LVEF. Dobutamine stress echocardiography (DSE) was performed before TAVR in a subset with very low LVEF, and presence of contractile reserve was defined as an increase of 20% or more in stroke volume. Clinical outcomes were assessed at 1 and 12 months and yearly thereafter, and echocardiography was performed at 1-year follow-up. Retrospective data were collected from 2007 to 2013 and prospective data from January 2013 to March 2018. Data were analyzed from March to October 2018. Exposures: Transcatheter aortic valve replacement in patients with LFLG AS. Main Outcomes and Measures: Changes in LVEF over time; periprocedural and late mortality. Results: A total of 293 patients were included, including 128 (43.7%) with very low LVEF and 165 with low LVEF (56.3%). Their mean (SD) age was 80 (7) years, and most (214 [73.0%]) were men. The mean (SD) LVEF in the very low LVEF group was 22% (5%), compared with 37% (7%) in the low LVEF group (P <.001). There were no differences between groups in rates of periprocedural mortality and late mortality (median [interquartile range], 23 [6-38] months). Patients with very low LVEF displayed a greater increase in LVEF at the 1-year follow-up examination (mean absolute increase, 11.9% [95% CI, 8.8%-15.1%]), than the low LVEF group (3.6% [95% CI, 1.1%-6.1%]; P <.001). In 92 patients with very low LVEF who had preprocedural DSE, results showed a lack of contractile reserve in 45 (49%), but this had no effect on clinical outcomes or changes in LVEF over time. Conclusions and Relevance: In patients with LFLG AS and severe left ventricular dysfunction, TAVR was associated with similar clinical outcomes as in counterparts with milder left ventricular dysfunction. The TAVR procedure was associated with a significant increase in LVEF, irrespective of contractile reserve. These results support TAVR for LFLG AS, irrespective of the severity of left ventricular dysfunction and DSE results.

AB - Importance: In low-flow, low-gradient aortic stenosis (LFLG AS), the severity of left ventricular dysfunction remains a key factor in the evaluation of aortic valve replacement. Objective: To evaluate the clinical outcomes and changes in left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR) in patients with LFLG AS and severe left ventricular dysfunction. Design, Setting, and Participants: This multicenter registry is a substudy of the True or Pseudo-Severe Aortic Stenosis-TAVI registry that included patients with classic LFLG AS, defined as a mean transvalvular gradient less than 35 mm Hg, an effective orifice area less than 1.0 cm2, and an LVEF of 40% or less. Patients were divided in groups with very low (<30%) LVEF and low (30%-40%) LVEF. Dobutamine stress echocardiography (DSE) was performed before TAVR in a subset with very low LVEF, and presence of contractile reserve was defined as an increase of 20% or more in stroke volume. Clinical outcomes were assessed at 1 and 12 months and yearly thereafter, and echocardiography was performed at 1-year follow-up. Retrospective data were collected from 2007 to 2013 and prospective data from January 2013 to March 2018. Data were analyzed from March to October 2018. Exposures: Transcatheter aortic valve replacement in patients with LFLG AS. Main Outcomes and Measures: Changes in LVEF over time; periprocedural and late mortality. Results: A total of 293 patients were included, including 128 (43.7%) with very low LVEF and 165 with low LVEF (56.3%). Their mean (SD) age was 80 (7) years, and most (214 [73.0%]) were men. The mean (SD) LVEF in the very low LVEF group was 22% (5%), compared with 37% (7%) in the low LVEF group (P <.001). There were no differences between groups in rates of periprocedural mortality and late mortality (median [interquartile range], 23 [6-38] months). Patients with very low LVEF displayed a greater increase in LVEF at the 1-year follow-up examination (mean absolute increase, 11.9% [95% CI, 8.8%-15.1%]), than the low LVEF group (3.6% [95% CI, 1.1%-6.1%]; P <.001). In 92 patients with very low LVEF who had preprocedural DSE, results showed a lack of contractile reserve in 45 (49%), but this had no effect on clinical outcomes or changes in LVEF over time. Conclusions and Relevance: In patients with LFLG AS and severe left ventricular dysfunction, TAVR was associated with similar clinical outcomes as in counterparts with milder left ventricular dysfunction. The TAVR procedure was associated with a significant increase in LVEF, irrespective of contractile reserve. These results support TAVR for LFLG AS, irrespective of the severity of left ventricular dysfunction and DSE results.

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