Table 1

Baseline Clinical and Echocardiographic Characteristics for the RESPOND As-Treated Population (N = 996)

Age, yrs80.8 ± 6.5
STS score6.0 ± 6.9
Katz Index Activities of Daily Living Score5.6 ± 1.0
Diabetes mellitus, medically treated22.4
COPD, moderate or severe7.7
NYHA functional class III or IV69.5
Atrial fibrillation, history33.9
Coronary artery disease, history56.1
Prior PCI29.8
Prior CABG12.3
Cerebrovascular accident, history9.5
Prior implanted pacemaker13.3
Echocardiographic assessments—core lab
 Aortic valve area (effective orifice area), cm20.7 ± 0.2
 Mean aortic valve gradient, mm Hg38.0 ± 15.5
 Peak aortic valve gradient, mm Hg61.9 ± 24.2
 Left ventricular ejection fraction, %49.8 ± 10.5
 Aortic regurgitation, moderate or severe11.7

Values are mean ± SD or %.

CABG = coronary artery bypass graft; COPD = chronic obstructive pulmonary disease; NYHA = New York Heart Association; PCI = percutaneous coronary intervention; RESPOND = Repositionable Lotus Valve System—Post-Market Evaluation of Real World Clinical Outcomes trial; STS = Society of Thoracic Surgeons.

  • Risk scores were not routinely collected/reported by all study centers.

  • Severe in 14 patients (1.5%).