Background
Methods
Patient selection
Procedure indication
Procedure
Post-procedure follow-up
Study outcomes
Statistical analysis
Results
Baseline characteristics
Total (N = 118) | Hemodialysis (N = 25) | Non-hemodialysis (N = 93) | p value | |
---|---|---|---|---|
Demographics | ||||
Age, years | 79 (73, 84) | 73 (71, 79) | 80 (75, 84) | < 0.001* |
Men | 81 (69%) | 20 (80%) | 61 (66%) | 0.13 |
Body mass index, kg/m2 | 23.3 (20.6, 25.5) | 21.6 (20.0, 24.4) | 23.4 (21.0, 25.6) | 0.22 |
Vital signs | ||||
Systolic blood pressure, mmHg | 120 (105, 135) | 125 (111, 136) | 117 (104, 132) | 0.069 |
Diastolic blood pressure, mmHg | 67 (58, 79) | 65 (55, 72) | 68 (58, 79) | 0.12 |
Pulse rate, bpm | 65 (59, 74) | 66 (58, 75) | 68 (59, 74) | 0.89 |
Comorbidity | ||||
Heart failure | 73 (62%) | 9 (36%) | 64 (69%) | 0.003* |
Hypertension | 87 (74%) | 16 (64%) | 71 (76%) | 0.025* |
Dyslipidemia | 65 (55%) | 18 (72%) | 47 (51%) | 0.044* |
Diabetes mellitus | 38 (32%) | 12 (48%) | 26 (28%) | 0.05 |
Ischemic heart disease | 51 (43%) | 14 (56%) | 37 (40%) | 0.11 |
Peripheral artery disease | 11 (9%) | 6 (24%) | 5 (5%) | 0.011* |
Carotid artery stenosis | 6 (5%) | 3 (12%) | 3 (3%) | 0.076 |
Hepatic disease | 5 (4%) | 0 | 5 (5%) | 0.24 |
Chronic obstructive pulmonary disease | 3 (3%) | 0 | 3 (3%) | 0.49 |
History of major bleeding | 59 (50%) | 7 (28%) | 52 (56%) | 0.013* |
Increased risk of fall | 28 (24%) | 4 (16%) | 24 (26%) | 0.23 |
History of ischemic stroke | 47 (40%) | 15 (60%) | 32 (34%) | 0.019* |
History of hemorrhagic stroke | 12 (10%) | 3 (12%) | 9 (9%) | 0.48 |
History of transient ischemic attach | 8 (7%) | 1 (4%) | 7 (7%) | 0.53 |
Laboratory data | ||||
Hemoglobin, g/dL | 12.1 (10.8, 13.6) | 11.3 (10.8, 12.1) | 12.5 (10.9, 13.9) | 0.017* |
Serum albumin, g/dL | 3.8 (3.5, 4.1) | 3.6 (3.4, 3.9) | 3.9 (3.6, 4.1) | 0.010* |
Estimated glomerular filtration ratio, mL/min/1.73m2 | 42 (24, 57) | 5 (5, 7) | 48 (35, 61) | < 0.001* |
Plasma B-type natriuretic peptide, pg/mL | 169 (82, 288) | 394 (260, 745) | 132 (66, 202) | < 0.001* |
Prothrombin time with international normalized ratio | 1.21 (1.04, 1.47) | 1.41 (1.18, 1.86) | 1.17 (1.01, 1.41) | 0.004* |
Echocardiography data | ||||
Left ventricular end-diastolic diameter, mm | 48 (44, 52) | 52 (47, 55) | 47 (43, 50) | 0.77 |
Left ventricular ejection fraction, % | 61 (52, 68) | 64 (46, 75) | 63 (57, 69) | 0.76 |
Left atrial volume index, mL/m2 | 60 (44, 82) | 45 (35, 57) | 60 (41, 82) | 0.17 |
Moderate or greater mitral regurgitation | 12 (10%) | 0 | 12 (13%) | 0.058 |
Moderate or greater tricuspid regurgitation | 17 (14%) | 0 | 17 (18%) | 0.021* |
Mild or greater spontaneous contrast | 64 (54%) | 12 (48%) | 52 (56%) | 0.32 |
Score | ||||
CHADS2 score | 3 (2, 4) | 3 (2, 4) | 3 (2, 4) | 0.98 |
CHADS2-VASc score | 5 (4, 6) | 5 (4, 6) | 5 (4, 6) | 0.66 |
HAS-BLEAD score | 3 (2, 3) | 4 (3, 5) | 3 (2, 3) | < 0.001* |
Clinical frailty scale | 3 (3, 4) | 3 (3, 4) | 3 (3, 4) | 0.87 |
Modified Rankin scale | 0 (0, 1) | 1 (0, 2) | 0 (0, 1) | 0.67 |
Total (N = 80) | Hemodialysis (N = 22) | Non-hemodialysis (N = 58) | p value | |
---|---|---|---|---|
LAA ostium diameter | ||||
LAA ostium diameter at 0 degree, mm | 21 (19, 24) | 21 (17, 24) | 22 (20, 23) | 0.61 |
LAA ostium diameter at 45 degrees, mm | 20 (17, 22) | 19 (15, 21) | 20 (18, 22) | 0.16 |
LAA ostium diameter at 90 degrees, mm | 20 (19, 23) | 20 (17, 24) | 21 (19, 23) | 0.65 |
LAA ostium diameter at 135 degrees, mm | 22 (20, 26) | 22 (19, 27) | 22 (21, 26) | 0.55 |
LAA depth | ||||
LAA depth at 0 degree, mm | 21 (15, 29) | 29 (17, 33) | 20 (13, 24) | 0.22 |
LAA depth at 45 degrees, mm | 27 (18, 33) | 31 (23, 35) | 25 (18, 31) | 0.19 |
LAA depth at 90 degrees, mm | 26 (17, 31) | 27 (24, 35) | 21 (17, 30) | 0.13 |
LAA depth at 135 degrees, mm | 24 (20, 30) | 29 (20, 35) | 24 (19, 28) | 0.085 |
Flow velocity | ||||
LAA filling flow velocity, m/sec | 33 (20, 49) | 45 (19, 57) | 29 (20, 40) | 0.20 |
LAA emptying flow velocity, m/sec | 25 (17, 45) | 43 (16, 54) | 22 (18, 39) | 0.12 |
PV flow velocity of S wave, m/sec | 30 (17, 42) | 39 (16, 49) | 28 (18, 41) | 0.22 |
PV flow velocity of D wave, m/sec | 33 (21, 41) | 31 (21, 41) | 36 (21, 42) | 0.81 |
LAAC procedure
Total (N = 118) | Hemodialysis (N = 25) | Non-hemodialysis (N = 93) | p value | |
---|---|---|---|---|
Procedure success | 117 (99%) | 25 (100%) | 92 (99%) | 0.60 |
Procedural parameters | ||||
Anesthesia time, min | 117 (101, 135) | 126 (118, 161) | 115 (100, 128) | 0.002* |
Procedural time, min | 55 (43, 70) | 65 (56, 96) | 51 (41, 64) | < 0.001* |
Fluoroscopy duration, min | 15 (10, 20) | 17 (13, 21) | 14 (10, 18) | 0.022* |
Contrast volume, mL | 65 (50, 80) | 75 (60, 95) | 60 (50, 75) | 0.003* |
Device data | ||||
Device type | ||||
WATCHMAN 2.5 | 48 (41%) | 17 (68%) | 31 (33%) | 0.007* |
WATCHMAN FLX | 69 (58%) | 8 (32%) | 61 (66%) | 0.007* |
Device size, cm | 31 (27, 33) | 33 (27, 33) | 31 (27, 33) | 0.44 |
Implantation data | ||||
Multiple device use | 12 (10%) | 5 (20%) | 7 (8%) | 0.067 |
Partial recapture | 63 (53%) | 15 (60%) | 48 (52%) | 0.60 |
Total (N = 118) | Hemodialysis (N = 25) | Non-hemodialysis (N = 92) | p value | |
---|---|---|---|---|
In-hospital duration, days | 4 (4, 5) | 4 (4, 5) | 4 (4, 5) | 0.81 |
Access site-related complication | 0 | 0 | 0 | – |
Transesophageal echocardiography-related complication | 0 | 0 | 0 | – |
Pulmonary complication | 0 | 0 | 0 | – |
Acute kidney injury | 0 | NA | 0 | – |
Pericardial effusion | 0 | 0 | 0 | – |
Device embolization | 0 | 0 | 0 | – |
Atrial septal defect requiring closure | 0 | 0 | 0 | – |
Infectious endocarditis | 0 | 0 | 0 | – |
Stroke | 0 | 0 | 0 | – |
Any bleeding | 1 (1%) | 1 (4%) | 0 | 0.053 |
All-cause death | 0 | 0 | 0 | – |
Trends in medications
Total | Hemodialysis | Non-hemodialysis | p value | |
---|---|---|---|---|
Baseline (N = 117) | (N = 117) | (N = 25) | (N = 92) | |
Antiplatelet | 0.007* | |||
None | 67 (57%) | 8 (32%) | 59 (63%) | – |
SAPT | 48 (41%) | 15 (60%) | 33 (35%) | – |
DAPT | 3 (3%) | 2 (8%) | 1 (1%) | – |
Warfarin | 32 (27%) | 25 (100%) | 8 (9%) | < 0.001* |
DOAC | 85 (72%) | 0 | 85 (91%) | < 0.001* |
Discharge (N = 117) | (N = 117) | (N = 25) | (N = 92) | |
Antiplatelet | 0.011* | |||
None | 24 (21%) | 1 (4%) | 23 (25%) | – |
SAPT | 93 (79%) | 24 (96%) | 69 (74%) | – |
DAPT | 0 | 0 | 0 | – |
Warfarin | 33 (28%) | 25 (100%) | 8 (9%) | < 0.001* |
DOAC | 85 (72%) | 0 | 85 (91%) | < 0.001* |
45-day follow-up (N = 94) | (N = 94) | (N = 21) | (N = 73) | |
Antiplatelet | 0.05 | |||
None | 18 (19%) | 0 | 18 (25%) | – |
SAPT | 76 (81%) | 21 (100%) | 55 (75%) | – |
DAPT | 0 | 0 | 0 | – |
Warfarin | 25 (27%) | 20 (95%) | 5 (7%) | < 0.001* |
DOAC | 68 (72%) | 0 | 68 (93%) | < 0.001* |
Short-term follow-up data
Hemodialysis (N = 21) | Non-hemodialysis (N = 73) | p value | |
---|---|---|---|
Device maximum diameter | |||
Device maximum diameter at 0 degree, mm | 27.7 (23.6, 29.0) | 26.8 (24.2, 29.0) | 0.94 |
Device maximum diameter at 45 degrees, mm | 26.4 (22.3, 29.6) | 26.1 (13.7, 27.9) | 0.81 |
Device maximum diameter at 90 degrees, mm | 27.5 (23.2, 30.0) | 26.2 (24.4, 29.0) | 0.25 |
Device maximum diameter at 145 degrees, mm | 28.0 (23.2, 30.0) | 26.2 (24.4, 29.0) | 0.54 |
Device compression | |||
Device compression at 0 degree, mm | 14.3 (12.1, 19.4) | 11.1 (9.2, 15.1) | 0.004* |
Device compression at 45 degrees, mm | 15.5 (12.7, 23.3) | 13.3 (10.0, 18.4) | 0.077 |
Device compression at 90 degrees, mm | 16.4 (9.3, 18.1) | 12.1 (9.7, 17.4) | 0.46 |
Device compression at 145 degrees, mm | 14.5 (10.0, 19.7) | 12.3 (9.1, 15.0) | 0.31 |
Peri-device leak > 5 mm | 0 | 1 (1%) | 0.59 |
Device protrusion | |||
Device protrusion at 0 degree, mm | 6.0 (4.0, 7.0) | 6.4 (4.0, 8.4) | 0.53 |
Device protrusion at 45 degrees, mm | 5.8 (5.0, 6.9) | 6.0 (4.2, 7.5) | 0.95 |
Device protrusion at 90 degrees, mm | 8.0 (4.9, 9.7) | 6.1 (4.5, 8.0) | 0.24 |
Device protrusion at 145 degrees, mm | 8.0 (6.1, 11.0) | 6.6 (5.3, 8.4) | 0.05 |
ASD | |||
ASD direction | 0.63 | ||
None | 7 (33%) | 34 (47%) | – |
Left to right | 12 (57%) | 35 (48%) | – |
Right to left | 0 | 0 | – |
Bi-direction | 1 (5%) | 4 (5%) | – |
ASD diameter, mm | 3.0 (1.5, 3.5) | 3.0 (2.0, 3.0) | 0.98 |
ASD pressure gradient, mmHg | 6.3 (4.5, 12.0) | 5.0 (3.1, 8.7) | 0.37 |
Complications | |||
Pericardial effusion | 0 | 0 | – |
Device-related thrombus | 0 | 0 | – |
Deep device implantation | 0 | 0 | – |
All-cause death | 0 | 1 (1%) | 0.88 |