Table 1.
Baseline and Operative Characteristics
| Suction-based Extraction (N=118) |
Controla (N=120) |
Intra-aortic Filtration (N=133) |
Controla (N=132) |
|
|---|---|---|---|---|
| Baseline Characteristicsb | ||||
| Male sex | 69 (58.5) | 77 (64.2) | 81 (60.9) | 86 (65.2) |
| White | 108 (91.5) | 107 (89.2) | 126 (94.7) | 118 (89.4) |
| Age – yrs | 74.6 (6.8) | 73.4 (6.7) | 73.6 (6.6) | 73.6 (6.7) |
| Medical and surgical history | ||||
| Diabetes | 48 (40.7) | 36 (30.0) | 36 (27.1) | 37 (28.0) |
| Renal insufficiency | 15 (12.7) | 13 (10.8) | 18 (13.5) | 14 (10.6) |
| Myocardial infarction | 16 (13.6) | 8 (6.7) | 15 (11.3) | 10 (7.6) |
| Atrial fibrillation | 14 (11.9) | 16 (13.3) | 13 (9.8) | 16 (12.1) |
| Stroke or TIA | 16 (13.6) | 8 (6.7) | 11 (8.3) | 8 (6.1) |
| SF-12c | ||||
| Physical Health Composite Score | 41.4 (10.6) | 40.5 (11.2) | 40.1 (11.0) | 40.2 (11.2) |
| Mental Health Composite Score | 53.2 (9.3) | 52.9 (9.3) | 52.9 (9.6) | 52.9 (9.4) |
| Severe Cognitive Impairmentd | ||||
| Verbal Memory | 16/114 (14.0) | 14/116 (12.1) | 19/127 (15.0) | 16/128 (12.5) |
| Executive Function | 18/98 (18.4) | 15/106 (14.2) | 21/119 (17.6) | 18/117 (15.4) |
| Auditory-Verbal Simple Attention | 5/115 (4.3) | 6/116 (5.2) | 4/127 (3.1) | 6/128 (4.7) |
| Visuomotor/Information Processing Speed | 9/109 (8.3) | 9/113 (8.0) | 11/123 (8.9) | 9/125 (7.2) |
| At least one deficit | 37/102 (36.3) | 28/109 (25.7) | 36/121 (29.8) | 31/120 (25.8) |
| White Matter Lesion Volume (mm3) | 4592 (2433, 8377) | 4719 (2201, 9776) | 6303 (2686, 10027) | 4704 (2265, 9776) |
| Presence of Large Cortical Lesionse | 1/96 (1.0) | 2/107 (1.9) | 2/109 (1.8) | 2/114 (1.8) |
| Maximum Atheroma Gradef | 2.5 (0.7) | 2.4 (0.6) | 2.3 (0.7) | 2.3 (0.6) |
| Operative Characteristicsb | ||||
| Surgical Procedure | ||||
| Isolated AVR | 67 (56.8) | 73 (60.8) | 77 (57.9) | 80 (60.6) |
| AVR & CABG | 50 (42.4) | 47 (39.2) | 51 (38.3) | 52 (39.4) |
| AVR & MV Repair ± CABG | 1 (0.8) | 0 | 5 (3.8) | 0 |
| Concomitant proceduresg | 17 (14.4) | 19 (15.8) | 23 (17.3) | 20 (15.2) |
| Duration of cardiopulmonary bypass – min | 104.9 (39.6) | 102.2 (40.2) | 109.1 (42.4) | 101.7 (39.8) |
| Debris Captured in Filter(s) | 79/106 (74.5) | - | 115/116 (99.1) | - |
| Type of Debris Captured | ||||
| Calcification | 30/106 (28.3) | - | 23/116 (19.8) | - |
| Valve Tissue and/or Arterial Wall | 53/106 (50.0) | - | 113/116 (97.4) | - |
| Platelet-Rich Thrombus | 55/106 (51.9) | - | 39/116 (33.6) | - |
| Other | 8/106 (7.5) | - | 13/116 (11.2) | - |
As the trial began with randomization to Intra-aortic Filtration or control, the first 12 control patients served as controls for Intra-aortic Filtration only and 120 patients were common to both control groups.
Categorical measures are presented as the number of patients and (%). If the denominator is not equal to the group sample size, data is presented as the number of patients/the number observed (%). White matter lesion volume is presented as median (IQR) and all other continuous measures are presented as mean (standard deviation).
The SF-12 composite scores are normed as T-scores (mean=50, SD=10); a higher score indicates a better health state
Severe cognitive impairment is defined as falling below 2 SD from the mean of an age-standardized population. Cognition was measured using a battery of tests including Hopkins Verbal Learning Test – Revised (HVLT-R), Controlled Oral Word Association Test (COWA), Trail Making Test – Parts A & B, Medical College of Georgia Complex Figures, and Wechsler Adult Intelligence Scale – 3rd Revision (WAIS-III, Digit Symbol Coding Subtest and Digits Span Subtest)
A large cortical lesion is defined as having a chronic infarct involving cortical gray matter of maximum diameter greater than or equal to 4.0 cm
Atheroma was examined in the ascending aorta and the aortic arch and graded according to Katz. The maximum grade is reported. Katz’s grade ranges from 1 to 5 with 1 representing normal to mild intimal thickening and 5 indicating any thickness with mobile component.31
The most common concomitant procedures were annular enlargement for valve placement, ascending aorta repair or replacement, and left atrial appendage ligation