Table 2

Clinical Outcomes at 1 Year in the RESPOND As-Treated Population (N = 996)

All-cause mortality116 (11.7)
 Cardiovascular mortality74 (7.6)
All stroke48 (4.9)
 Disabling stroke40 (4.1)
Major vascular complications34 (3.4)
Life-threatening or disabling bleeding35 (3.6)
Acute kidney injury (stage 2 or 3)17 (1.7)
Myocardial infarction18 (1.9)
Repeat procedure for valve-related dysfunction2 (0.2)
Hospitalization for valve-related symptoms or CHF78 (8.3)
New onset atrial fibrillation or atrial flutter33 (3.3)
Prosthetic valve thrombosis8 (0.8)
Prosthetic valve endocarditis13 (1.4)
Permanent pacemaker implantation
 Among all patients319 (32.3)
 Among patients without pacemaker at baseline (n = 864)319 (37.2)

Values are n (%) based on Kaplan-Meier rates.

CHF = congestive heart failure; RESPOND = Repositionable Lotus Valve System—Post-Market Evaluation of Real World Clinical Outcomes trial.