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Transcatheter aortic valve replacement and standard therapy in inoperable patients with aortic stenosis and low EF
  1. Jonathan J Passeri1,
  2. Sammy Elmariah1,2,
  3. Ke Xu3,
  4. Ignacio Inglessis1,
  5. Joshua N Baker4,
  6. Maria Alu3,
  7. Susheel Kodali3,
  8. Martin B Leon3,
  9. Lars G Svensson5,
  10. Philippe Pibarot6,
  11. William F Fearon7,
  12. Ajay J Kirtane3,
  13. Gus J Vlahakes4,
  14. Igor F Palacios1,
  15. Pamela S Douglas8
  16. on behalf of the PARTNER Investigators
  1. 1Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
  2. 2Harvard Clinical Research Institute, Boston, Massachusetts, USA
  3. 3Columbia University Medical Center/New York–Presbyterian Hospital, The Cardiovascular Research Foundation, New York, New York, USA
  4. 4Department of Cardiac Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
  5. 5Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA
  6. 6Québec Heart and Lung Institute, Laval University, Québec, Canada
  7. 7Stanford University School of Medicine, Stanford, California, USA
  8. 8Duke Clinical Research Institute/Duke University Medical Center, Durham, North Carolina, USA
  1. Correspondence to Dr Jonathan Passeri, Massachusetts General Hospital, 55 Fruit Street, YAW 5700, Boston, MA 02114, USA; jpasseri@mgh.harvard.edu and Dr Sammy Elmariah, Massachusetts General Hospital, 55 Fruit Street, GRB 800, Boston, MA 02114, USA; selmariah{at}mgh.harvard.edu

Abstract

Objectives The aims of this study were to evaluate the effect of left ventricular (LV) dysfunction on clinical outcomes after transcatheter aortic valve replacement (TAVR) and standard therapy for severe aortic stenosis (AS) and to assess LV ejection fraction (LVEF) recovery and its impact on subsequent clinical outcomes.

Methods Cohort B of the Placement of AoRtic TraNscathetER Valves trial randomised 342 inoperable patients with severe AS to TAVR or standard therapy. We defined LV dysfunction as an LVEF <50% and LVEF improvement as an absolute increase in LVEF ≥10% at 30 days.

Results Baseline LV dysfunction did not affect survival after TAVR but was associated with increased cardiac mortality at 1 year with standard therapy (59.3% vs 45.8% with normal LVEF; HR=1.71 (95% CI 1.08 to 2.71); p=0.02). In those with LV dysfunction, LVEF improvement occurred in 48.7% and 30.4% of TAVR and standard therapy patients, respectively (p=0.08), and was independently predicted by relative wall thickness and receipt of TAVR. LVEF improvement with standard therapy portended reduced all-cause mortality at 1 year (28.6% vs 65.6% without LVEF improvement; HR=0.32 (95% CI 0.11 to 0.93); p=0.03) but not at 2 years.

Conclusions In inoperable patients with severe AS, mild-to-moderate LV dysfunction is associated with higher cardiac mortality with standard therapy but not TAVR. A subset of patients undergoing standard therapy with LV dysfunction demonstrates LVEF improvement and favourable 1-year but not 2-year survival. TAVR improves survival and should be considered the standard of care for inoperable patients with AS and LVEF >20%.

Trial registration number ClinicalTrials.gov Unique Identifier #NCT00530894.

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