| Literature DB >> 34398676 |
Chak-Yu So1,2, Guson Kang1, Pedro A Villablanca1, Abel Ignatius1, Saleha Asghar1, Dilshan Dhillon1, James C Lee1, Arfaat Khan1, Gurjit Singh1, Tiberio M Frisoli1, Brian P O'Neill1, Marvin H Eng1, Thomas Song3, Milan Pantelic3, William W O'Neill1, Dee Dee Wang1.
Abstract
Background Transesophageal echocardiogram is currently the standard preprocedural imaging for left atrial appendage occlusion. This study aimed to assess the additive value of preprocedural computed tomography (CT) planning versus stand-alone transesophageal echocardiogram imaging guidance to left atrial appendage occlusion. Methods and Results We retrospectively reviewed 485 Watchman implantations at a single center to compare the outcomes of using additional CT preprocedural planning (n=328, 67.6%) versus stand-alone transesophageal echocardiogram guidance (n=157, 32.4%) for left atrial appendage occlusion. The primary end point was the rate of successful device implantation without major peri-device leak (>5 mm). Secondary end points included major adverse events, total procedural time, delivery sheath and devices used, risk of major peri-device leak and device-related thrombus at follow-up imaging. A single/anterior-curve delivery sheath was used more commonly in those who underwent CT imaging (35.9% versus 18.8%; P<0.001). Additional preprocedural CT planning was associated with a significantly higher successful device implantation rate (98.5% versus 94.9%; P=0.02), a shorter procedural time (median, 45.5 minutes versus 51.0 minutes; P=0.03) and a less frequent change of device size (5.6% versus 12.1%; P=0.01), particularly device upsize (4% versus 9.4%; P=0.02). However, there was no significant difference in the risk of major adverse events (2.1% versus 1.9%; P=0.87). Only 1 significant peri-device leak (0.2%) and 5 device-related thrombi were detected in follow-up (1.2%) with no intergroup difference. Conclusions Additional preprocedural planning using CT in Watchman implantation was associated with a higher successful device implantation rate, a shorter total procedural time, and a less frequent change of device sizes.Entities:
Keywords: atrial fibrillation; computed tomography; left atrial appendage occlusion; three‐dimensional printing; transesophageal echocardiography
Mesh:
Year: 2021 PMID: 34398676 PMCID: PMC8649286 DOI: 10.1161/JAHA.120.020615
Source DB: PubMed Journal: J Am Heart Assoc ISSN: 2047-9980 Impact factor: 5.501
Figure Case example of Watchman implantation using computed tomography (CT) for preprocedural planning.
A, Left atrial appendage (LAA) landing zone dimensions measured by CT. B, The depth measured perpendicular to the LAA landing zone and the optimal fluoroscopic deployment projection determined by CT. C, In vitro testing to select the curvature of the delivery sheath, which achieved coaxiality to the LAA landing zone for optimal deployment. D, The landing zone size measured by intraprocedural TEE, which was consistently smaller than that by preprocedural CT. E, LAA angiogram at predetermined fluoroscopic projection. F, Postimplantation CT 3‐dimensional reconstruction.
Baseline Patient Characteristics
| Overall (n=485) | Additive CT (n=328) | Stand‐Alone TEE (n=157) |
| |
|---|---|---|---|---|
| Age | 77.5±8.5 | 77.5±8.7 | 77.4±8.2 | 0.93 |
| Sex, male | 265 (54.6) | 180 (54.9) | 85 (54.1) | 0.88 |
| BMI, kg/m2 | 29.4±6.4 | 28.7±6.2 | 30.9±6.8 | 0.001 |
| CHADS2‐VASc Score | 4.5±1.5 | 4.5±1.5 | 4.5±1.3 | 0.85 |
| HAS‐BLED score | 3.1±1.0 | 3.2±1.0 | 2.9±1.0 | 0.006 |
| History of CHF | 232 (47.8) | 165 (50.3) | 67 (42.7) | 0.12 |
| History of hypertension | 438 (90.3) | 296 (90.2) | 142 (90.4) | 0.94 |
| History of DM | 198 (40.8) | 125 (38.1) | 73 (46.5) | 0.08 |
| History of Stroke/TIA | 179 (36.9) | 130 (39.6) | 49 (31.2) | 0.07 |
| History of prior bleeding | 404 (83.3) | 272 (82.9) | 132 (84.1) | 0.75 |
| History of ICH | 68 (14) | 45 (13.7) | 23 (14.6) | 0.78 |
| History of gastrointestinal bleed | 231 (45.9) | 150 (45.7) | 81 (51.6) | 0.23 |
| History of renal impairment | 56 (11.5) | 40 (12.2) | 16 (10.2) | 0.52 |
| LVEF, % | 55.9±10.7 | 55.6±11.2 | 56.4±9.5 | 0.42 |
| Concomitant procedures | 20 (4.1) | 13 (4.0) | 7 (4.5) | 0.80 |
| Baseline creatinine, mg/dL | 1.1 (0.5) | 1.085 (0.50) | 1.1 (0.58) | 0.70 |
| Maximum ostium diameter (intraprocedural TEE), mm | 22.4±3.9 | 22.4±3.7 | 22.4±3.6 | 0.96 |
Data were presented as mean ±SD or median (interquartile range) or n (%). BMI indicates body mass index; CHF, congestive heart failure; CT, computed tomography; DM, diabetes mellitus; ICH, intracranial hemorrhage; LVEF, left ventricular ejection fraction; TEE, transesophageal echocardiogram; and TIA, transient ischemic attack.
Renal dialysis, renal transplant, creatinine >2.26 mg/dL or >200 µmol/L.
For those with successful Watchman implantation.
Left Atrial Appendage Sizing Analysis by CT Versus TEE for the Same Patient
| CT | TEE | Mean Difference |
| |
|---|---|---|---|---|
| Maximum ostium diameter, mm | 25.2 ± 3.7 | 22.4 ± 3.8 | +2.8 (+2.2 to +3.4) | <0.001 |
| Minimum ostium diameter, mm | 20.3 ± 4.0 | 17.0 ± 3.3 | +3.4 (+2.8 to +4.0) | <0.001 |
| Maximum depth, mm | 29.7 ± 6.8 | 29.2 ± 5.4 | + 0.5 (−0.4 to +1.5) | 0.28 |
Data are presented as mean±SD or mean difference (95% CI). CT indicates computed tomography; and TEE, transesophageal echocardiogram.
Procedural Outcomes and Complications
| Overall (n=485) | Additive CT (n=328) | Stand‐Alone TEE (n=157) | Odds Ratio (95% CI) |
| |
|---|---|---|---|---|---|
| Successful device implantation | 472 (97.3) | 323 (98.5) | 149 (94.9) | 3.45 (1.11–11.1) | 0.02 |
| Major adverse events | 10 (2.1) | 7 (2.1) | 3 (1.9) | 0.87 | |
| Device embolization | 0 | 0 | 0 | 0.99 | |
| Procedural related MI | 0 | 0 | 0 | 0.99 | |
| Procedural stroke | 1 (0.2) | 1 (0.3) | 0 | 0.99 | |
| New pericardial effusion | 7 (1.4) | 5 (1.5) | 2 (1.3) | 0.99 | |
| Pericardial effusion requiring intervention | 4 (0.8) | 3 (0.9) | 1 (0.6) | 0.99 | |
| Surgical conversion | 0 | 0 | 0 | 0.99 | |
| Peri‐procedural death | 2 (0.4) | 1 (0.3) | 1 (0.6) | 0.54 |
Data are presented as n (%). CT indicates computed tomography; MI, myocardial infarction; and TEE, transesophageal echocardiogram.
Procedural Characteristics of Successful Watchman Implantations
| Overall (n=472) | Additive CT (n=323) | Stand‐Alone TEE (n=149) | Difference |
| |
|---|---|---|---|---|---|
| Total procedural time (skin to skin), min | 48 (37, 61) | 45.5 (37, 59) | 52.5 (39, 66) | –7.0 | 0.03 |
| Total radiation dose, mGy | 219 (126, 418) | 239.0 (139, 427) | 176 (90, 373) | +63 | 0.03 |
| Total contrast used, mL | 50.0 (30, 75) | 50.0 (35, 76) | 40.0 (20, 75) | +10 | 0.30 |
| Odds radio (95% CI) | |||||
| Delivery sheath used | <0.001 | ||||
| Single curve | 39 (8.3) | 36 (11.1) | 3 (2.0) | ||
| Double curve | 328 (69.5) | 207 (64.1) | 121 (81.2) | ||
| Anterior curve | 105 (22.2) | 80 (24.8) | 25 (16.8) | ||
| Anterior or single curve | 144 (30.5) | 116 (35.9) | 28 (18.8) | ||
| Number of delivery sheath used | 1 (1, 1) | 1 (1, 1) | 1 (1, 1) | 0.91 | |
| Change of delivery Sheath | 23 (4.9) | 16 (5.0) | 7 (4.7) | 0.99 | |
| Device implanted | 0.02 | ||||
| 21 mm | 43 (9.1) | 24 (7.4) | 19 (12.8) | ||
| 24 mm | 112 (23.7) | 84 (26.0) | 28 (18.8) | ||
| 27 mm | 142 (30.1) | 91 (28.2) | 51 (34.2) | ||
| 30 mm | 100 (21.2) | 64 (19.8) | 36 (24.2) | ||
| 33 mm | 75 (15.9) | 60 (18.6) | 15 (10.1) | ||
| Number of device used | 1 (1, 1) | 1 (1, 1) | 1 (1, 1) | 0.84 | |
| Change of device size | 36 (7.6) | 18 (5.6) | 18 (12.1) | 2.3 (1.1–4.6) | 0.02 |
| Upsize | 27 (5.7) | 13 (4) | 14 (9.4) | 2.4 (1.1–5.4) | 0.031 |
| Downsize | 9 (1.9) | 5 (1.5) | 4 (2.7) | 0.47 | |
| Number of partial recapture | 0 (0, 0) | 0 (0, 0) | 0 (0, 0) | 0.99 | |
| Need of partial recapture | 112 (23.7) | 77 (23.8) | 35 (23.5) | 0.79 |
Data are presented as median (25th percentile, 75th percentile) or n (%). CT indicates computed tomography; mGy, milligray; and TEE, transesophageal echocardiogram.
Clinical and Imaging Follow‐Up Outcomes of Successful Watchman Implantations at 45 Days
| Overall (n=472) | Additive CT (n=323) | Stand‐Alone TEE (n=149) | Odds Ratio (95% CI) |
| |
|---|---|---|---|---|---|
| 45‐d clinical follow‐up | 440 (93.2) | 303 (93.8) | 137 (91.9) | 0.44 | |
| 45‐d imaging follow‐up | <0.001 | ||||
| No follow‐up imaging | 51 (10.8) | 35 (10.8) | 16 (10.7) | ||
| CT | 232 (49.2) | 221 (68.4) | 11 (7.4) | ||
| TEE | 189 (40.0) | 67 (20.7) | 122 (81.9) | ||
| Significant PDL (>5 mm) | 1 (0.2) | 1 (0.3) | 0 | 0.99 | |
| Any PDL | 79 (18.8) | 37 (12.9) | 42 (31.3) | 0.32 (0.2–0.54) | <0.001 |
| DRT | 5 (1.2%) | 4 (1.4%) | 1 (0.7%) | 0.99 |
Data are presented as n (%). CT indicates computed tomography; DRT, device‐related thrombus; PDL, peri‐device leak; and TEE, transesophageal echocardiogram.
Comparison of Procedural Outcomes With Other Major Clinical Studies or Registry
| Henry Ford Additive CT Cohort | Henry Ford Stand‐Alone TEE Cohort | PROTECT‐AF | PREVAIL | CAP | CAP‐2 | Post‐FDA Approval Registry | NCDR Registry | |
|---|---|---|---|---|---|---|---|---|
| Number of procedures | 328 | 157 | 463 | 269 | 566 | 579 | 3822 | 38 158 |
| Implantation success, % | 98.5 |
94.9
|
90.9
|
95.1
|
94.4
|
94.8
|
95.6
| 98.3 |
| Procedure time, min, median (1st–3rd quartile) | 46 (37–59) | 51 (39–67) | 51 (37–71) | 52 (40–73) | 46 (34–62) | 55 (39–80) | 50 (36–66) | N/A |
| Number of device used, mean | 1.3 | 1.3 | 1.6 | 1.5 | 1.4 | 1.4 | 1.38 | N/A |
| Pericardial tamponade, % | 0.9 | 0.6 | 4.3 | 1.9 | 1.4 | 1.9 | 1.02 | 1.39 |
| Device embolization, % | 0 | 0 | 0.6 | 0.7 | 0.2 | 0 | 0.24 | 0.07 |
Aggregate data combined from PROTECT‐AF, PREVAIL, CAP, CAP2, and the Post‐FDA Approval Experience. CAP indicates continued access to PROTECT‐AF; CAP2, continued access to PREVAIL; CT, computed tomography; FDA, Food and Drug Administration; LAA, left atrial appendage; N/A, not available; NCDR, National Cardiovascular Data Registry; PREVAIL, Prospective Randomized Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy; PROTECT‐AF, Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation; and TEE, transesophageal echocardiogram.
P value when compared with Henry Ford Additive CT cohort.
NCDR reported success rate among those with device deployed, device not attempted were excluded (7% of procedures were cancelled/aborted for multiple reasons).