Table 6

Safety and Effectiveness Outcomes by MR Cause (Degenerative or Functional)

Degenerative MR
(n = 105)
Functional MR
(n = 246)
Age, yrs81.8 ± 8.9 (105)73.2 ± 10 (246)
Patients over 75 yrs of age81.0 (85/105)48.4 (119/246)
Female40.0 (42/105)38.6 (95/246)
Previous coronary artery disease74.8 (77/105)85.4 (210/246)
Prior myocardial infarction29.5 (31/105)59.8 (146/244)
History of atrial fibrillation71.6 (73/102)67.0 (144/215)
Prior stroke9.5 (10/105)14.2 (35/246)
Diabetes29.5 (31/105)43.7 (107/245)
Moderate to severe renal disease26.7 (28/105)32.1 (79/246)
Chronic obstructive pulmonary disease (with or without O2 at home)28.5 (30/105)29.0 (71/245)
Hypertension89.5 (94/105)89.4 (220/246)
Previous cardiovascular surgery50.5 (53/105)63.8 (157/246)
Previous percutaneous coronary intervention35.2 (37/105)56.1 (138/246)
NYHA functional class III to IV heart failure81.9 (86/105)86.2 (212/246)
LV ejection fraction, %61.0 ± 10.1 (95)41.7 ± 11.5 (223)
LV end systolic diameter, cm3.4 ± 0.8 (92)4.7 ± 1.0 (231)
Safety outcome
 30-day mortality6.7 (7/105)4.1 (10/246)
 30-day major adverse event18.1 (19/105)19.1 (47/246)
 30-day major adverse event (excluding transfusions)8.6 (9/105)9.3 (23/246)
 30-day major bleeding complication11.4 (12/105)8.9 (22/246)
 12-month mortality23.8 (25/105)22.4 (55/246)
 12-month major adverse event36.2 (38/105)38.2 (94/246)
 12-month major adverse event (excluding transfusions)26.7 (28/105)28.5 (70/246)
Effectiveness measure
 Implant success: MR grade95 (100/105)96 (236/246)
 ≤1+ at discharge48.5 (48/99)45.1 (102/226)
 ≤2+ at discharge80.8 (80/99)88.1 (199/226)
 ≤1+ at 12 months30.9 (21/68)39.4 (62/157)
 ≤2+ at 12 months85.3 (58/68)82.8 (130/157)
 Improvement in LVEDV at 12 months, ml18.6 ± 22.3 (58)17.6 ± 35.0 (145)
 Improvement in LVESV at 12 months, ml4.3 ± 14.7 (58)9.6 ± 25.7 (144)
 Improvement in SF-36 physical component score at 12 months, points6.3 (62)4.2 (129)
 Improvement in SF-36 mental component score at 12 months, points4.3 (62)5.3 (129)
 NYHA functional class III or IV from baseline → 12 months, %78.9 → 12.7 (71)83.4 → 19.0 (63)
 Rate of hospitalizations for heart failure (12 months pre-procedure → 12 months post-discharge)0.71 → 0.21 (105)0.83 → 0.49 (246)

Values are mean ± SD (n) or % (n/N) unless otherwise indicated.

LVEDV = left ventricular end-diastolic volume; LVESV = left ventricular end-systolic volume; other abbreviations as in Tables 1 and 4.