Supplement to the Impact of Annular Size on Outcomes After Surgical Or Transcatheter Aortic

Supplement to The Impact of Annular Size on Outcomes After Surgical or Transcatheter Aortic Valve Replacement

G. Michael Deeb, MD, Stanley J. Chetcuti, MD, Steven J. Yakubov, MD, Himanshu J. Patel, MD, P. Michael Grossman, MD, Neal S. Kleiman, MD, John Heiser, MD, William Merhi, DO, George L. Zorn, III MD, Peter N. Tadros, MD, George Petrossian, MD, Newell Robinson, MD, Mubashir Mumtaz, MD, Thomas G. Gleason, MD, Jian Huang, MD, John V. Conte, MD, Jeffrey J. Popma, MD, Michael J. Reardon, MD

Contents

Supplemental Table 1.Surgical valve type by annular size group.

Supplemental Table 2.Echocardiographic core lab compliance, implanted cohort.

Supplemental Table 3.Baseline demographics by annular size.

Supplemental Table 4. Baseline demographics, TAVR vs. SAVR within each annular size.

Supplemental Table 5. Two-year clinical outcomes by annular size.

Supplemental Table 6. Two-year clinical outcomes; TAVR vs. SAVR within each annular size group.

Supplemental Table 1. Surgical valve type by annular size group.

SAVR
Large
(N=96) / Medium
(N=177) / Small
(N=74) / p-value
Implanted Valve
Medtronic Freestyle / 5/96 (5.2) / 13/177 (7.3) / 6/74 (8.1) / 0.72
Valve size (mm)
19 / 0/5 (0.0) / 0/13 (0.0) / 1/6 (16.7) / 0.01
21 / 0/5 (0.0) / 1/13 (7.7) / 1/6 (16.7)
23 / 0/5 (0.0) / 5/13 (38.5) / 4/6 (66.7)
25 / 3/5 (60.0) / 4/13 (30.8) / 0/6 (0.0)
27 / 2/5 (40.0) / 3/13 (23.1) / 0/6 (0.0)
29 / 0/5 (0.0) / 0/13 (0.0) / 0/6 (0.0)
Medtronic Mosaic / 17/96 (17.7) / 34/177 (19.2) / 16/74 (21.6) / 0.81
Valve size (mm)
19 / 0/17 (0.0) / 0/34 (0.0) / 4/16 (25.0) / < 0.001
21 / 1/17 (5.9) / 4/34 (11.8) / 7/16 (43.8)
23 / 4/17 (23.5) / 16/34 (47.1) / 5/16 (31.3)
25 / 8/17 (47.1) / 13/34 (38.2) / 0/16 (0.0)
27 / 3/17 (17.6) / 1/34 (2.9) / 0/16 (0.0)
29 / 1/17 (5.9) / 0/34 (0.0) / 0/16 (0.0)
Medtronic Hancock II / 6/96 (6.3) / 13/177 (7.3) / 2/74 (2.7) / 0.37
Valve size (mm)
19 / 0/6 (0.0) / 0/13 (0.0) / 0/2 (0.0) / 0.18
21 / 0/6 (0.0) / 4/13 (30.8) / 1/2 (50.0)
23 / 3/6 (50.0) / 5/13 (38.5) / 1/2 (50.0)
25 / 2/6 (33.3) / 4/13 (30.8) / 0/2 (0.0)
27 / 1/6 (16.7) / 0/13 (0.0) / 0/2 (0.0)
29 / 0/6 (0.0) / 0/13 (0.0) / 0/2 (0.0)
Medtronic 3F / 0/96 (0.0) / 5/177 (2.8) / 1/74 (1.4) / 0.22
Valve size (mm)
19 / 0 / 0/5 (0.0) / 0/1 (0.0) / 0.16
21 / 0 / 1/5 (20.0) / 1/1 (100.0)
23 / 0 / 4/5 (80.0) / 0/1 (0.0)
25 / 0 / 0/5 (0.0) / 0/1 (0.0)
27 / 0 / 0/5 (0.0) / 0/1 (0.0)
29 / 0 / 0/5 (0.0) / 0/1 (0.0)
Edwards Perimount / 35/96 (36.5) / 57/177 (32.2) / 22/74 (29.7) / 0.63
Valve size (mm)
19 / 0/35 (0.0) / 4/57 (7.0) / 6/22 (27.3) / < 0.001
21 / 6/35 (17.1) / 26/57 (45.6) / 13/22 (59.1)
23 / 15/35 (42.9) / 21/57 (36.8) / 3/22 (13.6)
25 / 12/35 (34.3) / 6/57 (10.5) / 0/22 (0.0)
27 / 1/35 (2.9) / 0/57 (0.0) / 0/22 (0.0)
29 / 1/35 (2.9) / 0/57 (0.0) / 0/22 (0.0)
Sorin MitroFlow / 6/96 (6.3) / 15/177 (8.5) / 9/74 (12.2) / 0.39
Valve size (mm)
19 / 0/6 (0.0) / 1/15 (6.7) / 3/9 (33.3) / 0.01
21 / 2/6 (33.3) / 8/15 (53.3) / 5/9 (55.6)
23 / 0/6 (0.0) / 5/15 (33.3) / 1/9 (11.1)
25 / 4/6 (66.7) / 1/15 (6.7) / 0/9 (0.0)
27 / 0/6 (0.0) / 0/15 (0.0) / 0/9 (0.0)
29 / 0/6 (0.0) / 0/15 (0.0) / 0/9 (0.0)
St Jude Biocor/Epic / 3/96 (3.1) / 8/177 (4.5) / 6/74 (8.1) / 0.31
Valve size (mm)
19 / 0/3 (0.0) / 1/8 (12.5) / 4/6 (66.7) / 0.03
21 / 1/3 (33.3) / 4/8 (50.0) / 2/6 (33.3)
23 / 2/3 (66.7) / 3/8 (37.5) / 0/6 (0.0)
25 / 0/3 (0.0) / 0/8 (0.0) / 0/6 (0.0)
27 / 0/3 (0.0) / 0/8 (0.0) / 0/6 (0.0)
29 / 0/3 (0.0) / 0/8 (0.0) / 0/6 (0.0)
St Jude Trifecta / 23/96 (24.0) / 29/177 (16.4) / 12/74 (16.2) / 0.26
Valve size (mm)
19 / 0/23 (0.0) / 2/29 (6.9) / 4/12 (33.3) / < 0.001
21 / 2/23 (8.7) / 13/29 (44.8) / 7/12 (58.3)
23 / 9/23 (39.1) / 10/29 (34.5) / 1/12 (8.3)
25 / 6/23 (26.1) / 3/29 (10.3) / 0/12 (0.0)
27 / 6/23 (26.1) / 0/29 (0.0) / 0/12 (0.0)
29 / 0/23 (0.0) / 1/29 (3.4) / 0/12 (0.0)
Other / 1/96 (1.0) / 3/177 (1.7) / 0/74 (0.0) / 0.51
Valve size (mm)
19 / 0/1 (0.0) / 0/3 (0.0) / 0
21 / 1/1 (100.0) / 2/3 (66.7) / 0
23 / 0/3 (0.0) / 0/3 (0.0) / 0
25 / 0/1 (0.0) / 1/3 (33.3) / 0
27 / 0/1 (0.0) / 0/3 (0.0) / 0
29 / 0/1 (0.0) / 0/3 (0.0) / 0

Values are presented as no./total no. (%)

Supplemental Table 2. Echocardiographic core lab compliance, implanted cohort.

Visit Interval / Number Expected / Visits Performed / Core Echo Performed
TAVR
Baseline / 390 / 390 (100.0) / 389 (99.7)
Post Procedure / 390 / 390 (100.0) / 382 (97.9)
Discharge / 384 / 383 (99.7) / 371 (96.6)
1Month / 375 / 368 (98.1) / 366 (97.6)
6Months / 354 / 337 (95.2) / 325 (91.8)
1 Year / 328 / 323 (98.5) / 303 (92.4)
2 Years / 296 / 279 (94.3) / 251 (84.8)
SAVR
Baseline / 354 / 354 (100.0) / 354 (100.0)
Post Procedure / 354 / 354 (100.0) / 335 (94.6)
Discharge / 349 / 349 (100.0) / 330 (94.6)
1Month / 340 / 326 (95.9) / 319 (93.8)
6Months / 301 / 277 (92.0) / 259 (86.0)
1 Year / 280 / 263 (93.9) / 233 (83.2)
2 Years / 235 / 219 (93.2) / 186 (79.1)

Values are presented as no. (%).

Supplemental Table 3. Baseline demographics by annular size.

TAVR / SAVR
Characteristic / Large
(N=115) / Medium
(N=170) / Small
(N=104) / p-value / Large
(N=96) / Medium
(N=177) / Small
(N=74) / p-value
Body surface area (m2) / 2.0±0.2 / 1.8±0.2 / 1.7±0.2 / < 0.001 / 2.0±0.2 / 1.8±0.2 / 1.7±0.2 / < 0.001
Age (years) / 82.5±7.3 / 83.5±6.7 / 83.4±7.4 / 0.48 / 84.0±6.8 / 82.8±6.2 / 83.4±6.4 / 0.27
STS Risk of Mortality (%) / 6.8±3.2 / 7.3±2.9 / 8.0±3.1 / 0.01 / 7.1±3.5 / 7.4±3.2 / 8.3±3.6 / 0.07
Logistic EuroScore (%) / 19.0±14.5 / 18.1±13.5 / 15.2±10.0 / 0.07 / 18.5±13.0 / 18.9±13.1 / 19.2±13.9 / 0.94
Male sex / 103 (89.6) / 90 (52.9) / 12 (11.5) / < 0.001 / 83 (86.5) / 91 (51.4) / 3 (4.1) / < 0.001
NYHA Class / 0.46 / 0.43
I / 0 (0.0) / 0 (0.0) / 0 (0.0) / 0 (0.0) / 0 (0.0) / 0 (0.0)
II / 20 (17.4) / 19 (11.2) / 18 (17.3) / 8 (8.3) / 26 (14.7) / 12 (16.2)
III / 67 (58.3) / 119 (70.0) / 69 (66.3) / 70 (72.9) / 120 (67.8) / 50 (67.6)
IV / 28 (24.3) / 32 (18.8) / 17 (16.3) / 18 (18.8) / 31 (17.5) / 12 (16.2)
Coronary artery disease / 96 (83.5) / 127 (74.7) / 70 (67.3) / 0.02 / 76 (79.2) / 128 (72.3) / 60 (81.1) / 0.23
Previous MI / 34 (29.6) / 44 (25.9) / 21 (20.2) / 0.28 / 26 (27.1) / 46 (26.0) / 17 (23.0) / 0.82
Prior balloon valvuloplasty / 7 (6.1) / 9 (5.3) / 6 (5.8) / 0.96 / 5 (5.2) / 13 (7.3) / 3 (4.1) / 0.56
Peripheral vascular disease / 50 (44.2) / 60 (35.5) / 48 (46.2) / 0.15 / 42 (44.7) / 70 (39.5) / 31 (41.9) / 0.71
Chronic lung disease / 51 (44.3) / 79 (46.5) / 45 (43.3) / 0.86 / 45 (46.9) / 77 (43.5) / 32 (43.2) / 0.85
Home oxygen / 11 (9.6) / 26 (15.3) / 12 (11.7) / 0.34 / 7 (7.3) / 27 (15.3) / 6 (8.1) / 0.08
Creatinine >2 mg/dL / 7 (6.1) / 3 (1.8) / 1 (1.0) / 0.04 / 5 (5.2) / 5 (2.8) / 5 (6.8) / 0.33
Atrial fibrillation / 46 (40.4) / 72 (42.4) / 41 (39.4) / 0.88 / 51 (53.1) / 80 (45.2) / 28 (37.8) / 0.14
Pre-existing IPG/ICD / 37 (32.2) / 33 (19.4) / 21 (20.2) / 0.03 / 26 (27.1) / 30 (16.9) / 18 (24.3) / 0.12

Values are presented as mean±standard deviation or no. (%).

Supplemental Table 4. Baseline demographics, TAVR vs. SAVR within each annular size.

Large / Medium / Small
TAVR(N=115) / SAVR(N=96) / p-value / TAVR
(N=170) / SAVR
(N=177) / P-value / TAVR
(N=104) / SAVR
(N=74) / p-value
Body surface area (m2) / 2.0 ± 0.2 / 2.0 ± 0.2 / 0.67 / 1.8 ± 0.2 / 1.8 ± 0.2 / 0.94 / 1.7 ± 0.2 / 1.7 ± 0.2 / 0.89
Age (years) / 82.5 ± 7.3 / 84.0± 6.8 / 0.11 / 83.5± 6.7 / 82.8± 6.2 / 0.31 / 83.4 ± 7.4 / 83.4 ± 6.4 / 0.96
STS Risk of Mortality (%) / 6.8 ± 3.2 / 7.1 ± 3.5 / 0.43 / 7.3 ± 2.9 / 7.4 ± 3.2 / 0.66 / 8.0 ± 3.1 / 8.3 ± 3.6 / 0.52
Logistic EuroScore (%) / 19.0 ± 14.5 / 18.5± 13.0 / 0.79 / 18.1 ± 13.5 / 18.9± 13.1 / 0.60 / 15.2 ± 10.0 / 19.2 ± 13.9 / 0.03
Male sex / 103 (89.6) / 83(86.5) / 0.49 / 90(52.9) / 91(51.4) / 0.78 / 12 (11.5) / 3 (4.1) / 0.10
NYHA Class / 0.74 / 0.43 / 0.91
I / 0 (0.0) / 0 (0.0) / 0 (0.0) / 0 (0.0) / 0 (0.0) / 0 (0.0)
II / 20 (17.4) / 8 (8.3) / 19 (11.2) / 26(14.7) / 18 (17.3) / 12 (16.2)
III / 67 (58.3) / 70(72.9) / 119 (70.0) / 120(67.8) / 69 (66.3) / 50 (67.6)
IV / 28 (24.3) / 18 (18.8) / 32(18.8) / 31 (17.5) / 17 (16.3) / 12 (16.2)
Coronary artery disease / 96 (83.5) / 76(79.2) / 0.42 / 127(74.7) / 128(72.3) / 0.61 / 70 (67.3) / 60 (81.1) / 0.04
Previous MI / 34 (29.6) / 26(27.1) / 0.69 / 44 (25.9) / 46 (26.0) / 0.98 / 21 (20.2) / 17 (23.0) / 0.66
Prior balloon valvuloplasty / 7 (6.1) / 5 (5.2) / 0.78 / 9 (5.3) / 13 (7.3) / 0.43 / 6 (5.8) / 3 (4.1) / 0.74
Peripheral vascular disease / 50 (44.2) / 42(44.7) / 0.95 / 60(35.5) / 70(39.5) / 0.44 / 48 (46.2) / 31 (41.9) / 0.57
Chronic lung disease / 51(44.3) / 45(46.9) / 0.71 / 79(46.5) / 77(43.5) / 0.58 / 45(43.3) / 32(43.2) / 0.99
Home oxygen / 11 (9.6) / 7 (7.3) / 0.56 / 26 (15.3) / 27(15.3) / 0.99 / 12 (11.7) / 6 (8.1) / 0.44
Creatinine >2 mg/dL / 7 (6.1) / 5 (5.2) / 0.78 / 3 (1.8) / 5 (2.8) / 0.72 / 1 (1.0) / 5 (6.8) / 0.08
Atrial fibrillation / 46 (40.4) / 51(53.1) / 0.06 / 72(42.4) / 80(45.2) / 0.59 / 41 (39.4) / 28 (37.8) / 0.83
Pre-existing IPG/ICD / 37 (32.2) / 26 (27.1) / 0.42 / 33 (19.4) / 30 (16.9) / 0.55 / 21 (20.2) / 18 (24.3) / 0.51
Baseline medications
Aspirin / 94 (81.7) / 72 (75.0) / 0.23 / 135 (79.4) / 122 (68.9) / 0.03 / 76 (73.1) / 56 (75.7) / 0.70
Antiplatelets / 53 (46.1) / 25 (26.0) / 0.003 / 70 (41.2) / 43 (24.3) / 0.001 / 32 (30.8) / 21 (28.4) / 0.73
Anticoagulants / 29 (25.2) / 26 (27.1) / 0.76 / 37 (21.8) / 56 (31.6) / 0.04 / 19 (18.3) / 23 (31.1) / 0.05

Values are presented as mean ± standard deviation or no. (%)

Supplemental Table 5. Two-year clinical outcomes by annular size.

TAVR / SAVR
Large
(N=115) / Medium
(N=170) / Small
(N=104) / p-value / Large
(N=96) / Medium
(N=177) / Small
(N=74) / p-value
All-cause mortality or major stroke / 34 (29.7) / 34 (20.1) / 24 (23.4) / 0.19 / 30 (31.7) / 59 (33.8) / 20 (28.0) / 0.56
All-cause mortality / 30 (26.2) / 31 (18.3) / 23 (22.5) / 0.30 / 25 (26.6) / 52 (29.9) / 18 (25.2) / 0.60
Cardiovascular / 21 (18.8) / 20 (12.1) / 16 (15.8) / 0.31 / 19 (20.6) / 31 (18.9) / 10 (14.2) / 0.63
Reintervention / 6 (5.7) / 2 (1.3) / 1 (1.0) / 0.05 / 1 (1.2) / 0 (0.0) / 0 (0.0) / 0.33
All stroke / 17 (15.8) / 13 (8.0) / 10 (10.2) / 0.15 / 10 (11.8) / 29 (18.6) / 11 (16.4) / 0.35
Major stroke / 11 (10.1) / 9 (5.6) / 5 (4.9) / 0.27 / 6 (7.3) / 18 (11.6) / 4 (6.0) / 0.30
TIA / 4 (3.7) / 5 (3.4) / 0 (0.0) / 0.18 / 1 (1.2) / 3 (2.0) / 1 (1.4) / 0.89
Bleeding (major/life-threatening or disabling) / 43 (38.1) / 77 (45.8) / 57 (55.3) / 0.03 / 62 (65.2) / 130 (73.6) / 59 (80.1) / 0.07
Life-threatening or disabling / 21 (18.8) / 29 (17.5) / 18 (17.5) / 0.96 / 42 (44.6) / 67 (38.1) / 28 (38.3) / 0.65
Major bleed / 27 (24.0) / 54 (32.1) / 41 (40.5) / 0.03 / 28 (29.8) / 68 (38.7) / 36 (49.7) / 0.03
Major vascular complication / 6 (5.3) / 11 (6.6) / 10 (10.0) / 0.41 / 4 (4.2) / 2 (1.1) / 0 (0.0) / 0.08
Acute kidney injury / 6 (5.3) / 12 (7.1) / 5 (5.0) / 0.71 / 15 (15.6) / 28 (15.8) / 10 (13.5) / 0.88
Myocardial infarction
Aortic valve hospitalization / 27 (26.4) / 34 (21.2) / 23 (25.4) / 0.69 / 17 (19.4) / 21 (13.8) / 14 (22.4) / 0.33
New permanent pacemaker1 / 23 (20.8) / 49 (30.0) / 24 (24.5) / 0.24 / 16 (17.6) / 18 (11.2) / 7 (10.4) / 0.21
Moderate/severe paravalvular regurgitation / 3/70 (4.3) / 7/116 (6.0) / 4/63 (6.3) / 0.85 / 1/51 (2.0) / 0/85 (0.0) / 0/43 (0.0) / 0.28

Values represent Kaplan-Meier estimates and are presented as the no. of patients with an event (%), with the exception of moderate/severe paravalvular regurgitation data which are presented as no./total no. of echos (%).

1SubjectswithpacemakerorICDatbaselineareincluded.
For time-to-event variables, p-valueiscalculatedbasedonLog-ranktest. For paravalvular regurgitation, Chi-square test was used.

Supplemental Table 6. Two-year clinical outcomes; TAVR vs. SAVR within each annular size group.

Large / Medium / Small
TAVR (N=115) / SAVR (N=96) / p-value / TAVR (N=170) / SAVR (N=177) / p-value / TAVR
(N=104) / SAVR
(N=74) / p-value
All-cause mortality or major stroke / 34 (29.7) / 30 (31.7) / 0.84 / 34 (20.1) / 59 (33.8) / 0.003 / 24 (23.4) / 20 (28.0) / 0.56
All-cause mortality / 30 (26.2) / 25 (26.6) / 0.99 / 31 (18.3) / 52 (29.9) / 0.01 / 23 (22.5) / 18 (25.2) / 0.70
Cardiovascular / 21 (18.8) / 19 (20.6) / 0.79 / 20 (12.1) / 31 (18.9) / 0.08 / 16 (15.8) / 10 (14.2) / 0.78
Reintervention / 6 (5.7) / 1 (1.2) / 0.09 / 2 (1.3) / 0 (0.0) / 0.18 / 1 (1.0) / 0 (0.0) / 0.40
All stroke / 17 (15.8) / 10 (11.8) / 0.37 / 13 (8.0) / 29 (18.6) / 0.01 / 10 (10.2) / 11 (16.4) / 0.30
Major stroke / 11 (10.1) / 6 (7.3) / 0.40 / 9 (5.6) / 18 (11.6) / 0.06 / 5 (4.9) / 4 (6.0) / 0.87
TIA / 4 (3.7) / 1 (1.2) / 0.25 / 5 (3.4) / 3 (2.0) / 0.56 / 0 (0.0) / 1 (1.4) / 0.24
Bleeding (major/life-threatening or disabling) / 43 (38.1) / 62 (65.2) / <0.001 / 77 (45.8) / 130 (73.6) / <0.001 / 57 (55.3) / 59 (80.1) / <0.001
Life-threatening or disabling / 21 (18.8) / 42 (44.6) / <0.001 / 29 (17.5) / 67 (38.1) / <0.001 / 18 (17.5) / 28 (38.3) / 0.002
Major bleed / 27 (24.0) / 28 (29.8) / 0.36 / 54 (32.1) / 68 (38.7) / 0.17 / 41 (40.5) / 36 (49.7) / 0.22
Major vascular complication / 6 (5.3) / 4 (4.2) / 0.73 / 11 (6.6) / 2 (1.1) / 0.01 / 10 (10.0) / 0 (0.0) / 0.01
Acute kidney injury / 6 (5.3) / 15 (15.6) / 0.01 / 12 (7.1) / 28 (15.8) / 0.01 / 5 (5.0) / 10 (13.5) / 0.046
Myocardial infarction / 2 (2.0) / 2 (2.7) / 0.86 / 2 (1.2) / 3 (1.8) / 0.65 / 3 (3.0) / 2 (2.8) / 0.93
Aortic valve hospitalization / 27 (26.4) / 17 (19.4) / 0.38 / 34 (21.2) / 21 (13.8) / 0.08 / 23 (25.4) / 14 (22.4) / 0.61
New permanent pacemaker1 / 23 (20.8) / 16 (17.6) / 0.49 / 49 (30.0) / 18 (11.2) / <0.001 / 24 (24.5) / 7 (10.4) / 0.01
Moderate/severe paravalvular regurgitation / 3/70 (4.3) / 1/51 (2.0) / 0.64 / 7/116 (6.0) / 0/85 (0.0) / 0.02 / 4/63 (6.3) / 0/43 (0.0) / 0.14

1SubjectswithpacemakerorICDatbaselineareincluded.
For time-to-event variables, p-valueiscalculatedbasedonLog-ranktest. For paravalvular regurgitation, Chi-square test was used.