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Brief Report
January 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

Author Affiliations
  • 1Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada
  • 2Emory University Hospital, Atlanta, Georgia
  • 3Centre Hospitalier Régional et Universitaire de Brest, Brest, France
  • 4University of Pittsburgh Medical Center, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 5Cedars Sinai Heart Institute, Los Angeles, California
  • 6University of Pennsylvania Medical Center, Philadelphia
  • 7Bern University Hospital, Bern, Switzerland
  • 8Mayo Clinic, Rochester, Minnesota
  • 9St Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada
  • 10Hospital Clínico San Carlos-Madrid, Madrid, Spain
  • 11Hospital Clinico Universitario de Valladolid, Valladolid, Spain
  • 12Hospital Virgen de la Victoria, Malaga, Spain
  • 13Hospital Universitari Vall d'Hebron, Barcelona, Spain
  • 14Washington University in St Louis School of Medicine, St Louis, Missouri
  • 15Cleveland Clinic, Cleveland, Ohio
JAMA Cardiol. 2019;4(1):64-70. doi:10.1001/jamacardio.2018.4320
Key Points

Question  What outcomes do patients with low-flow, low-gradient aortic stenosis (LFLG AS) and severely depressed left ventricular function (<30%) experience after transcatheter aortic valve replacement (TAVR)?

Findings  This multicenter registry study of 293 patients with LFLG AS found that, after TAVR, patients with very severe left ventricular dysfunction had greater improvements in left ventricular ejection fraction and similar clinical outcomes as patients with mild left ventricular dysfunction. These clinical outcomes were irrespective of the results of dobutamine stress echocardiography examination.

Meaning  Per these results, patients with LFLG AS should not be declined for TAVR on the basis of left ventricular dysfunction severity or dobutamine stress echocardiography results; TAVR appears to be a good alternative treatment for patients with LFLG AS and severe left ventricular dysfunction.

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.

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