Table 2. Primary, Secondary, and Exploratory Outcomes Among Patients With and Without Patent Foramen Ovale.
| Outcomes | PFO (n = 1540) | No PFO (n = 148 658) | Absolute RD, % (95% CI) | Adjusted Absolute RD, % (95% CI) | OR (95% CI)b | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. (%) | Estimated Probability, % (95% CI)a | No. (%) | Estimated Probability, % (95% CI)a | Unadjusted | P Value | Adjustedc | P Value | |||
| Primary | ||||||||||
| Perioperative ischemic stroke | 49 (3.2) | 0.6 (0.4 to 0.8) | 801 (0.5) | 0.2 (0.2 to 0.3) | 2.6 (1.8 to 3.5) | 0.4 (0.2 to 0.6) | 6.07 (4.52 to 8.13) | <.001 | 2.66 (1.96 to 3.63) | <.001 |
| Stroke subtyped | ||||||||||
| Total anterior | 18 (1.2) | 0.2 (0.08 to 0.3) | 214 (0.1) | 0.05 (0.04 to 0.07) | 1.0 (0.5 to 1.6) | 0.1 (0.04 to 0.2) | 8.34 (5.14 to 13.53)e | <.001 | 3.66 (2.20 to 6.08)e | <.001 |
| Partial anterior | 6 (0.4) | 0.07 (0.01 to 0.1) | 127 (0.1) | 0.03 (0.02 to 0.04) | 0.3 (−0.01 to 0.6) | 0.04 (−0.0002 to 0.001) | 4.69 (2.06 to 10.64)e | <.001 | 2.28 (0.98 to 5.30)e | .06 |
| Posterior circulation | 13 (0.8) | 0.2 (0.1 to 0.3) | 193 (0.1) | 0.05 (0.04 to 0.07) | 0.7 (0.3 to 1.2) | 0.1 (0.01 to 0.2) | 6.68 (3.80 to 11.74)e | <.001 | 3.14 (1.75 to 5.63)e | <.001 |
| Lacunar | 0 | 0 (0 to 0) | 37 (<0.1) | 0.002 (−0.002 to 0.006) | −0.02 (−0.03 to −0.02) | −0.002 (−0.006 to 0.002) | 0.00e | .99 | 0.00e | .99 |
| Unclassifiable | 12 (0.8) | 0.1 (0.04 to 0.2) | 230 (0.2) | 0.06 (0.04 to 0.07) | 0.6 (0.2 to 1.1) | 0.0006 (−0.0001 to 0.001) | 5.17 (2.89 to 9.27)e | <.001 | 1.98 (1.09 to 3.61)e | .026 |
| Large-vessel territory strokef | 37 (2.4) | 0.5 (0.3 to 0.6) | 534 (0.4) | 0.1 (0.1 to 0.2) | 2.0 (−14.5 to 18.6) | 0.003 (0.001 to 0.005) | 6.87 (4.91 to 9.63)e | <.001 | 3.14 (2.21 to 4.48)e | <.001 |
| Secondary Outcomes | ||||||||||
| 30-d readmission | 245 (15.9) | 7.0 (6.0 to 7.9) | 11 352 (7.6) | 6.1 (6.0 to 6.3) | 8.3 (6.4 to 10.10) | 0.8 (−0.1 to 1.8) | 2.29 (1.99 to 2.63) | <.001 | 1.15 (0.99 to 1.33) | .07 |
| 30-d mortality | 27 (1.8) | 0.1 (0.06 to 0.2) | 917 (0.6) | 0.1 (0.09 to 0.1) | 1.1 (0.5 to 1.8) | 0.01 (−0.05 to 0.04) | 2.88 (1.95 to 4.23) | <.001 | 0.95 (0.63 to 1.43) | .80 |
| Systemic embolic complications | ||||||||||
| Composite outcomeg | 50 (3.3) | 3.1 (2.3 to 4.0) | 2127 (1.4) | 1.4 (1.3 to 1.4) | 1.8 (0.9 to 2.7) | 1.8 (0.8 to 2.6) | 2.31 (1.74 to 3.07) | <.001 | 2.31 (1.74 to 3.08)h | <.001 |
| Renal artery embolism | 4 (0.3) | 0.3 (0.0 to 0.5) | 74 (0.1) | 0.05 (0.04 to 0.06) | 0.2 (−0.04 to 0.5) | 0.2 (0.04 to 0.2) | 5.23 (1.91 to 14.32) | .001 | 5.15 (1.88 to 14.13)h | .001 |
| Acute limb ischemia | 14 (0.9) | 0.8 (0.5 to 1.3) | 555 (0.4) | 0.4 (0.3 to 0.4) | 0.5 (0.1 to 1.0) | 0.5 (0.03 to 0.9) | 2.44 (1.44 to 4.17) | .001 | 2.31 (1.35 to 3.94)h | .002 |
| Acute intestinal vascular insufficiency | 7 (0.5) | 0.3 (0.08 to 0.6) | 284 (0.2) | 0.1 (0.1 to 0.2) | 0.3 (−0.07 to 0.6) | 0.2 (−0.07 to 0.4) | 2.39 (1.13 to 5.06) | .023 | 2.04 (0.96 to 4.33)h | .064 |
| Acute myocardial infarction | 45 (2.9) | 1.5 (1.1 to 2.0) | 922 (0.6) | 0.4 (0.4 to 0.4) | 2.3 (1.5 to 3.1) | 1.1 (0.7 to 1.6) | 4.82 (3.56 to 6.53) | <.001 | 1.60 (1.13 to 2.27) | .008 |
| Falsification testing | ||||||||||
| Septic shock | 15 (1.0) | 0.09 (0.04 to 0.1) | 525 (0.4) | 0.1 (0.08 to 0.1) | 0.6 (0.1 to 1.1) | −0.01 (−0.06 to 0.04) | 2.78 (1.66 to 4.65) | <.001 | 0.89 (0.52 to 1.52) | .67 |
| Wound complication | 103 (6.7) | 3.0 (2.4 to 3.6) | 6807 (4.6) | 3.3 (3.2 to 3.4) | 2.1 (0.9 to 3.4) | −0.3 (−0.9 to 0.3) | 1.49 (1.22 to 1.83) | <.001 | 0.90 (0.73 to 1.11) | .35 |
| Peptic ulcer disease | 8 (0.5) | 0.3 (0.1 to 0.5)i | 492 (0.3) | 0.2 (0.2 to 0.3)i | 0.2 (−0.2 to 0.5) | 0.06 (−0.15 to 0.27) | 1.57 (0.78 to 3.17) | .21 | 1.23 (0.61 to 2.49)i | .56 |
Abbreviations: IQR, interquartile range; OR, odds ratio; RD, risk difference.
Estimated probabilities were calculated by holding all other covariates at means.
ORs were derived from logistic regression.
If not stated otherwise, adjusted analyses were adjusted for baseline patient characteristics including age, sex, body mass index, American Society of Anesthesiologists physical status classification, and Charlson Comorbidity Index; coexisting conditions such as history of cigarette smoking, hypertension, diabetes, dyslipidemia, coronary artery disease, myocardial infarction, congestive heart failure, pulmonary edema, pulmonary hypertension, cardiomyopathy, congenital heart disease, atrial fibrillation, valvular heart disease, chronic obstructive pulmonary disease, migraine, chronic kidney disease, hypercoagulable state, deep vein thrombosis, pulmonary embolism, and systemic embolic phenomenon; prescription use within 28 days before surgery of β-blockers, statins, antiplatelet agents, and anticoagulants; factors relating to surgery including emergency surgery status, inpatient surgery, high-risk surgical service, duration of surgery, intraoperative hypotensive minutes, intraoperative dose of vasopressors, intraoperative fluid volumes, requirement for packed red blood cells transfusion, and work relative value units.
Stroke subtype by Oxford Community Stroke Project classification.
Relative risk ratio, derived from multinomial logistic regression.
Includes total anterior, partial anterior, and posterior circulation strokes.
Indicates composite outcome of acute embolic events in the extremities, kidneys, spleen, splanchnic circulation, and retina.
Values were adjusted for age, sex, and body mass index.
Values were adjusted for age, sex, body mass index, and the 3 most significant predictors of perioperative stroke (based on the β-coefficients in the primary logistic regression model)—emergency surgery status, inpatient surgery, and high-risk surgical service.