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 - Enriquez-Sarano, Maurice
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
N1 - Funding Information:
Funding/Support: This registry was supported by a grant (FDN-143225) from the Canadian Institutes of Health Research.
Funding Information:
in Valvular Heart Diseases, and receiving grants from Edwards Lifesciences and Medtronic during the conduct of the study and Cardiac Phoenix and V-Wave Ltd outside the submitted work. Dr Herrmann reports having received research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic, consultant fees from Edwards Lifesciences, and grants from University of Laval during the conduct of the study. Dr Windecker reports having received research contracts to the institution from Bracco, Boston Scientific, Terumo, Edwards Lifesciences, and Medtronic and grants from Abbott, Amgen, Edwards Lifesciences, Biotronik, Boston Scientific, Medtronic, St Jude, and Terumo, outside the submitted work. Dr Rodés-Cabau reports having received institutional research grants from Edwards Lifesciences and Medtronic and holds the Canadian Research Chair “Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions. Dr Maes reports being supported by a grant from the Fondation St-Luc (Brussels, Belgium). Dr Ribeiro reports having been supported by a research PhD grant from “CNPq, Conselho Nacional de Desenvolvimento Científico e Tecnológico–Brasil.” Dr Cavalcante reported grants from Medtronic Inc during the conduct of the study. Dr Makkar reports receiving grants from Abbott and Edwards Lifesciences during the conduct of the study and other payments from Cordis, Medtronic, and Cedars-Sinai Medical Center, outside the submitted work. Dr Enriquez-Sarano reports receiving grants from Edwards LLC during the conduct of the study. Dr Babaliaros reports receiving personal fees from Edwards Lifesciences and personal fees from Abbott Vascular outside the submitted work. Dr Gleason reports receiving grants from Medtronic
Publisher Copyright:
© 2018 American Medical Association. All rights reserved.
PY - 2019/1
Y1 - 2019/1
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 cm 2 , 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 cm 2 , 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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U2 - 10.1001/jamacardio.2018.4320
DO - 10.1001/jamacardio.2018.4320
M3 - Article
C2 - 30566185
AN - SCOPUS:85059132937
VL - 4
SP - 64
EP - 70
JO - JAMA Cardiology
JF - JAMA Cardiology
SN - 2380-6583
IS - 1
ER -