Table 4.

Association of Short-Term Complications with Outcomes

Complications in 30-days after TAVR	1-year mortality		1-year KCCQ-OS
	Adjusted HR (95% CI)	p-value	Adjusted Estimate (95% CI)	p-value
Major stroke	5.38 (3.05 to 9.50)	<0.001	−15.1 (−24.8 to −5.3)	0.003
Minor stroke	0.57 (0.14 to 2.29)	0.425	−2.4 (−8.3 to 3.6)	0.432
Life-threatening bleed	1.60 (1.03 to 2.49)	0.038	−3.4 (−6.9 to 0.0)	0.050
Major bleed	1.46 (1.08 to 1.97)	0.013	−1.9 (−4.1 to 0.2)	0.079
Major vascular event	0.77 (0.46 to 1.27)	0.302	0.3 (−3.0 to 3.6)	0.850
New pacemaker	0.99 (0.65 to 1.49)	0.948	0.3 (−2.4 to 2.9)	0.844
Acute kidney injury stage 3	4.92 (2.74 to 8.84)	<0.001	−14.7 (−25.6 to −3.8)	0.008
Moderate/severe paravalvular leak	1.88 (1.29 to 2.73)	0.001	−2.9 (−5.9 to 0.0)	0.053
Mild paravalvular leak	1.26 (0.96 to 1.65)	0.091	−2.1 (−3.8 to −0.5)	0.010

TAVR, transcatheter aortic valve replacement; KCCQ-OS, Kansas City Cardiomyopathy Questionnaire-Overall Summary score

All models included all complications and also adjusted for age, sex, prior CABG, peripheral vascular disease, diabetes, STS mortality risk score, non-transfemoral access, and baseline KCCQ-OS score

Negative KCCQ-OS estimates indicate that patients with these events had worse health status at 1 year. A 5-point change in KCCQ-OS is considered clinically significant