. 2016 Nov 1;16(19):1–94.

Table 11:

Adverse Outcomes After TAVI or BAV in Patients Who Were Not Suitable Candidates for Surgery: Intention-to-Treat Analysis^a

Author, Year	All-Cause Mortality, N (%)	Cardiovascular Mortality, N (%)	Aortic Regurgitation, N (%)		Stroke, N (%)	Vascular Complications, N (%)	Major Bleeding, N (%)	New Pacemaker, N (%)	Myocardial Infarction, N (%)	Renal Failure, N (%)
Author, Year	All-Cause Mortality, N (%)	Cardiovascular Mortality, N (%)	Paravalvular	Transvalvular	Stroke, N (%)	Vascular Complications, N (%)	Major Bleeding, N (%)	New Pacemaker, N (%)	Myocardial Infarction, N (%)	Renal Failure, N (%)
30 days Leon et al, 2010¹⁹	TAVI: 9 (5.0) BAV: 5 (2.8) P = .41	TAVI: 8 (4.5) BAV: 3 (1.7) P = .22	Moderate/severe TAVI: 17/141 (12.1) BAV: 0 (0) Mild TAVI: 74/141 (52.5) BAV: 0 (0)	Moderate/severe TAVI: 2/141 (1.3) BAV: 24/141 (16.9)	Major TAVI: 9 (5.0) BAV: 2 (1.1) P = .06 Minor TAVI: 3 (1.7) BAV: 1 (0.6) P = .62	All TAVI: 55 (30.7) BAV: 9 (5.0) P < .001 Major TAVI: 29 (16.2) BAV: 2 (1.1) P < .001	TAVI: 30 (16.8) BAV: 7 (3.9) P < .001	TAVI: 6 (3.4) BAV: 9 (5.0) P = .60	TAVI: 0 (0) BAV: 0 (0)	TAVI: 2 (1.1) BAV: 3 (1.7) P = 1.0
1 year Leon et al, 2010¹⁹	TAVI: 55 (30.7) BAV: 89 (49.7) P < .001	TAVI: 35 (19.6) BAV: 75 (41.9) P < .001	Moderate/severe TAVI: 7/89 (7.9) BAV: 0 (0) Mild TAVI: 40/89 (44.9) BAV: 0 (0)	Moderate/severe TAVI: 14/89 (15.7) BAV: 8/47 (17) Mild TAVI: 17/89 (19.1) BAV: 18/47 (38.3)	Major TAVI: 14 (7.8) BAV: 7 (3.9) P = .18 Minor TAVI: 4 (2.2) BAV: 1 (0.6) P = .37	All TAVI: 58 (32.4) BAV: 13 (7.3) P < .001 Major TAVI: 30 (16.8) BAV: 4 (2.2) P < .001	TAVI: 40 (22.3) BAV: 20 (11.2) P = .007	TAVI: 8 (4.5) BAV: 14 (7.8) P = .27	TAVI: 1 (0.6) BAV: 1 (0.6) P = 1.0	TAVI: 3 (1.7) BAV: 6 (3.4) P = .50
2 years Makkar et al, 2012¹³	TAVI: 77 (43.3) BAV: 117 (68.0) P < .001	TAVI: 50 (31.0) BAV: 100 (62.4) P < .001	Moderate/severe TAVI: 3/67 (4.5) BAV: 0 (0) Mild TAVI: 24/67 (35.8) BAV: 1/2 (50.0)	Moderate/severe TAVI: 2/67 (3.0) BAV: 3/23 (13) Mild TAVI: 11/67 (16.4) BAV: 10/23 (43.5)	Major TAVI: 18 (10.1) BAV: 7 (3.9) Minor TAVI: 4 (2.2) BAV: 1 (0.6)	NA	TAVI: 48 (28.9) BAV: 25 (20.1) P = .09	TAVI: 10 (6.4) BAV: 14 (8.6) P = .47	TAVI: 2 (1.6) BAV: 2 (2.5) P = .69	TAVI: 5 (3.2) BAV: 9 (7.6) P = .15
3 years Kapadia et al, 2014²⁵	TAVI: NA (54.1) BAV: NA (80.9) P < .0001	TAVI: NA (41.4) BAV: NA (74.5) P < .0001	Moderate/severe TAVI: 2/44 (4.5) BAV: NA Mild TAVI: 14/44 (31.8) BAV: NA	NA	TAVI: NA (15.7) BAV: NA (5.5) P = .004	Major TAVI: NA (17.4) BAV: NA (2.8) P < .0001	TAVI: NA (32.0) BAV: NA (32.9) P = .92	TAVI: NA (7.6) BAV: NA (8.6) P = .75	TAVI: NA (4.1) BAV: NA (2.5) P = .59	TAVI: NA (3.2) BAV: NA (11.1) P = .08
5 years Kapadia et al, 2015²⁸	TAVI: 130 (71.8) BAV: 174 (93.6) P < .0001	TAVI: (57.5) BAV: (85.9) P < .0001	NA	NA	NA	NA	NA	NA	NA	NA

Abbreviations: BAV, balloon aortic valvuloplasty; NA, not available; TAVI, transcatheter aortic valve implantation.

Percentages are based on Kaplan-Meier estimates as reported by the authors and do not equal the number of patients with events divided by the total number of patients.