Table 1. Baseline and Operative Characteristics.
| Suction-Based Extraction (n = 118) |
Intra-Aortic Filtration (n = 133) |
Controla (n = 132) |
|
|---|---|---|---|
| Baseline Characteristics | |||
| Male sex, No. (%) | 69 (58.5) | 81 (60.9) | 86 (65.2) |
| White race, No. (%) | 108 (91.5) | 126 (94.7) | 118 (89.4) |
| Age, mean (SD), y | 74.6 (6.8) | 73.6 (6.6) | 73.6 (6.7) |
| Medical and surgical history, No. (%) | |||
| Diabetes | 48 (40.7) | 36 (27.1) | 37 (28.0) |
| Renal insufficiency | 15 (12.7) | 18 (13.5) | 14 (10.6) |
| Myocardial infarction | 16 (13.6) | 15 (11.3) | 10 (7.6) |
| Atrial fibrillation | 14 (11.9) | 13 (9.8) | 16 (12.1) |
| Stroke or transient ischemic attack | 16 (13.6) | 11 (8.3) | 8 (6.1) |
| 12-Item Short-Form Health Survey score, mean (SD)b | |||
| Physical health composite | 41.4 (10.6) | 40.1 (11.0) | 40.2 (11.2) |
| Mental health composite | 53.2 (9.3) | 52.9 (9.6) | 52.9 (9.4) |
| Severe cognitive impairment, No./total (%)c | |||
| Verbal memory | 16/114 (14.0) | 19/127 (15.0) | 16/128 (12.5) |
| Executive function | 18/98 (18.4) | 21/119 (17.6) | 18/117 (15.4) |
| Auditory-verbal simple attention | 5/115 (4.3) | 4/127 (3.1) | 6/128 (4.7) |
| Visuomotor or information processing speed | 9/109 (8.3) | 11/123 (8.9) | 9/125 (7.2) |
| ≥1 Deficit | 37/102 (36.3) | 36/121 (29.8) | 31/120 (25.8) |
| White matter lesion volume, median (IQR), mm3 | 4592 (2433-8377) | 6303 (2686-10 027) | 4704 (2265-9776) |
| Large cortical lesions, No./total (%)d | 1/96 (1.0) | 2/109 (1.8) | 2/114 (1.8) |
| Maximum atheroma grade, mean (SD)e | 2.5 (0.7) | 2.3 (0.7) | 2.3 (0.6) |
| Operative Characteristics | |||
| Type of surgical procedure, No. (%) | |||
| Isolated aortic valve replacement | 67 (56.8) | 77 (57.9) | 80 (60.6) |
| Aortic valve replacement and CABG | 50 (42.4) | 51 (38.3) | 52 (39.4) |
| Aortic valve replacement and mitral valve repair with or without CABG | 1 (0.8) | 5 (3.8) | 0 |
| Concomitant procedures, No. (%)f | 17 (14.4) | 23 (17.3) | 20 (15.2) |
| Duration of cardiopulmonary bypass, mean (SD), min | 104.9 (39.6) | 109.1 (42.4) | 101.7 (39.8) |
| Debris captured in filter, No./total (%) | 79/106 (74.5) | 115/116 (99.1) | |
| Type of debris captured, No./total (%) | |||
| Calcification | 30/106 (28.3) | 23/116 (19.8) | |
| Valve tissue, arterial wall, or both | 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) | |
Abbreviations: CABG, coronary artery bypass graft; IQR, interquartile range.
The first 12 patients randomized to the control group served as controls for the intra-aortic filtration group only and the other 120 patients served as controls for both the suction-based extraction group and the intra-aortic filtration group (eTable 1 in Supplement 2).
A higher score indicates a better health state. Values are normed as t scores (mean, 50 [SD, 10]).
Defined as 2 SD or greater below the mean in an age-standardized population. Cognition was measured using the revised Hopkins Verbal Learning Test, the Controlled Oral Word Association Test, parts A and B of the Trail Making Test, the Medical College of Georgia Complex Figures, and the third revision of the Wechsler Adult Intelligence Scale.
Defined as having a chronic infarct involving cortical gray matter with a maximum diameter greater than or equal to 4.0 cm.
Examined in the ascending aorta and the aortic arch and graded according to the grading scale by Katz (range, 1-5; 1 indicates normal to mild intimal thickening and 5 indicates any thickness with a mobile component).
The most common were annular enlargement for valve placement, ascending aorta repair or replacement, and left atrial appendage ligation.