Table 3. Association of Off-label TAVR Use With 30-Day and 1-Year Adverse Cardiovascular Outcomes.
| Outcome | Unadjusted | Adjusteda | ||
|---|---|---|---|---|
| HR (95% CI) | P Value | HR (95% CI) | P Value | |
| At 30 d | ||||
| Mortality | 1.41 (1.16-1.71) | <.001 | 1.27 (1.04-1.55) | .02 |
| Heart failure | 1.34 (1.05-1.72) | .02 | 1.28 (0.98-1.66) | .07 |
| Stroke | 0.76 (0.50-1.15) | .20 | 0.80 (0.53-1.20) | .28 |
| MI | 1.33 (0.74-2.39) | .34 | 1.36 (0.74-2.51) | .32 |
| At 1 y | ||||
| Mortality | 1.21 (1.08-1.37) | .001 | 1.11 (0.98-1.25) | .11 |
| Heart failure | 1.15 (1.00-1.34) | .06 | 1.06 (0.92-1.22) | .45 |
| Stroke | 0.77 (0.54-1.10) | .15 | 0.80 (0.57-1.14) | .22 |
| MI | 1.14 (0.76-1.70) | .54 | 1.19 (0.79-1.79) | .40 |
Abbreviations: HR, hazard ratio; MI, myocardial infarction; TAVR, transcatheter aortic valve replacement.
Adjusted for age; sex; body surface area; left ventricular ejection fraction; hemoglobin level; platelet count; number of days from November 1, 2011, until procedure date; race; dialysis; left main coronary artery stenosis of 50% or more; proximal left anterior descending coronary artery stenosis of 70% or more; prior MI; endocarditis; prior stroke or transient ischemic attack; carotid stenosis; peripheral arterial disease; tobacco abuse; diabetes; New York Heart Association class IV; atrial fibrillation or flutter; conduction defect; severe chronic lung disease; home oxygen therapy; hostile chest; porcelain aorta; access site (femoral vs other); prior percutaneous coronary intervention; prior coronary artery bypass graft; prior cardiac operations (≥2 vs 1 vs 0); prior aortic valve procedure; prior nonaortic valve procedure; aortic stenosis etiologic factors (degenerative vs other); valve morphologic characteristics (tricuspid vs other); tricuspid insufficiency (moderate or severe vs other); and acuity (elective vs urgent vs shock or inotropes or assist device vs emergency or salvage or cardiac arrest).