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

• Authors: Frédéric Maes, Laval University; Stamatios Lerakis, Emory University; Henrique Barbosa Ribeiro, Laval University; Martine Gilard, Centre Hospitalier Régional et Universitaire de Brest; João L. Cavalcante, University of Pittsburgh; Raj Makkar, Cedars Sinai Heart Institute; Howard C. Herrmann, University of Pennsylvania; Stephan Windecker, Bern University Hospital; Maurice Enriquez-Sarano, Mayo Clinic; Asim N. Cheema, University of Toronto; Luis Nombela-Franco, Hospital Clínico San Carlos-Madrid; Ignacio Amat-Santos, Hospital Clinico Universitario de Valladolid; Antonio J. Munoz-Garcia, Hospital Virgen de la Victoria; Bruno Garcia del Blanco, Hospital Universitari Vall d'Hebron; Alan Zajarias, Washington University; John C. Lisko, Emory University; Salim Hayek, Emory University; Vasilis Babaliaros, Emory University; Florent Le Ven, Centre Hospitalier Régional et Universitaire de Brest; Thomas G. Gleason, University of Pittsburgh; Tarun Chakravarty, Cedars Sinai Heart Institute; Wilson Szeto, University of Pennsylvania
• Journal Title: JAMA Cardiology
• Volume: Volume 4, Number 1
• Publisher: American Medical Association (AMA) | 2019-01-01, Pages 64-70
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1001/jamacardio.2018.4320
• Subjects: Health Sciences, Medicine and Surgery; Health Sciences, Epidemiology; Engineering, Biomedical
• Keywords: Science & Technology; Life Sciences & Biomedicine; Cardiac & Cardiovascular Systems; Cardiovascular System & Cardiology; CONTRACTILE RESERVE; OPERATIVE RISK; DYSFUNCTION; IMPLANTATION; PREDICTORS; PLACEMENT; MORTALITY

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 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.