A New WATCHMAN Sizing Algorithm Utilizing Cardiac CTA

Nadeem, Fahd; Igwe, Chinedu; Stoycos, Stephen; Jaswaney, Rahul; Tsushima, Takahiro; Al‐Kindi, Sadeer; Bansal, Eric; Fares, Anas; Dallan, Luís Augusto Palma; Patel, Sandeep; Rajagopalan, Sanjay; Arruda, Mauricio; Filby, Steven J.; Bezerra, Hiram G.

doi:10.1016/j.carrev.2021.01.009

Cited by 9 publications

(19 citation statements)

References 14 publications

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“…Several studies have demonstrated advantages of CTA over TEE‐based measurements for LAAC 4,5,18–20 . CTA provides reproducible, fast, noninvasive acquisition with isotropic data, high‐spatial resolution data.…”

Section: Discussionmentioning

confidence: 99%

“…Due to the complex configuration of the LAA, especially with elliptical or irregularly‐shaped ostia, 5 we hypothesize that an area‐derived diameter is more accurate than using maximum diameter as the use of maximal diameter may lead to device over‐compression. We thus hold that device selection based on area‐derived diameter can reduce sizing error and improve selection accuracy 5,11,20 . To this point, our preprocedural CTA sizing strategy accurately predicted the implanted device size in >91% of patients with only 10 (7.4%) patients requiring a different device size than the one selected by our algorithm.…”

Section: Discussionmentioning

confidence: 99%

“…The current recommendation is to utilize maximum transesophageal echocardiogram (TEE)‐derived diameter for WATCHMAN™ (Boston Scientific Corporation) device sizing 1–3 . Cardiac computed tomography (computed tomography angiography [CTA]) is increasingly being utilized to guide WATCHMAN™ device sizing, however there is no consensus approach 4,5 . Whilst recent data has suggested an advantage of CTA over TEE for left atrial appendage closure (LAAC) planning, there has been limited published experience for a CT‐based sizing strategy.…”

Section: Introductionmentioning

confidence: 99%

“…Whilst recent data has suggested an advantage of CTA over TEE for left atrial appendage closure (LAAC) planning, there has been limited published experience for a CT‐based sizing strategy. CTA‐sizing methodologies remains heterogeneous among different institutions, with a paucity of data regarding the ideal way to perform this measurement for new generation devices 4–8 . We sought to analyze the safety and feasibility for the implementation of a novel CTA‐based sizing methodology for the new WATCHMAN™ FLX platform in LAAC using TruPlan™ software (Circle Cardiovascular Imaging Inc.).…”

Section: Introductionmentioning

confidence: 99%

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Novel computed tomography angiography‐based sizing methodology for WATCHMAN FLX device in left atrial appendage closure

Dallan

Arruda

Yoon

et al. 2022

Cardiovasc electrophysiol

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Background While there is recent data suggesting an advantage of computed tomography angiography (CTA) over transesophageal echocardiography (TEE) for preprocedural left atrial appendage closure (LAAC) planning, there is limited published experience for sizing strategies. Device sizing for LAAC may be challenging and noninvasive algorithms that improve this selection process are warranted. Objectives We sought to evaluate the safety and the feasibility for the implementation of a novel CTA‐based sizing methodology for WATCHMAN™ FLX device in a series of patients undergoing LAAC using the TruPlan™ software package. Methods A prospective analysis of 136 consecutive patients who underwent LAAC over a 12‐month period in a single, large academic hospital in the United States was conducted. CTA‐guided preprocedural planning and intracardiac echocardiography (ICE) was performed in all. Procedural success, adverse events, length of procedure, number of devices used, and length of stay were evaluated. Results A total of 136 patients who underwent LAAC procedure with WATCHMAN™ FLX platform between October 1, 2020 until September 30, 2021 were included. The pre‐specified protocol using CTA and ICE was implemented in all patients (100%). Mean CHA2DS2VASc score was 4.4 ± 1.3 and the mean HAS‐BLED score was 3.9 ± 0.8. ICE‐guided 100% transseptal puncture success rate was 100% with 98.5% of overall procedural success rate. Preprocedural CTA sizing strategy accurately predicted the implanted size in 91.1% of patients. Ten patients (7.4%) required another sized device and 2 cases were aborted. At 45‐day follow‐up, only 1 patient (0.7%) had significant peri‐device leak (≥5 mm) on TEE. Conclusions CTA‐based preprocedural sizing methodology for WATCHMAN™ FLX in LAAC was safe, feasible and associated with excellent procedural outcomes. Further studies are warranted to confirm if the features specific to TruPlan™ may reduce the number of deployment attempts, the number of devices utilized in the procedure, and the risk of complications.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Novel computed tomography angiography‐based sizing methodology for WATCHMAN FLX device in left atrial appendage closure

Dallan

Arruda

Yoon

et al. 2022

Cardiovasc electrophysiol

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“…Therefore, CT is being used increasingly for the pre-procedural assessment of other percutaneous procedures, including transcatheter aortic valve replacement 19 . Recent studies have reported that CT provides better accuracy for LAAO planning than TEE 13 , 20 – 22 , whereas it is still unclear which parameter should be used for sizing when using CT measurements to plan LAAO 15 . Therefore, our study aimed to establish a practical method of successfully using CT-based parameters to predict LAAO device sizes for ACP and Amulet.…”

Section: Discussionmentioning

confidence: 99%

Pre-procedural determination of device size in left atrial appendage occlusion using three-dimensional cardiac computed tomography

Cho

Kim

Lee

et al. 2021

Sci Rep

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The complex structure of the left atrial appendage (LAA) brings limitations to the two-dimensional-based LAA occlusion (LAAO) size prediction system using transesophageal echocardiography. The LAA anatomy can be evaluated more precisely using three-dimensional images from cardiac computed tomography (CT); however, there is lack of data regarding which parameter to choose from CT-based images during pre-procedural planning of LAAO. We aimed to assess the accuracy of measurements derived from cardiac CT images for selecting LAAO devices. We retrospectively reviewed 62 patients with Amplatzer Cardiac Plug and Amulet LAAO devices who underwent implantation from 2017 to 2020. The minimal, maximal, average, area-derived, and perimeter-derived diameters of the LAA landing zone were measured using CT-based images. Predicted device sizes using sizing charts were compared with actual successfully implanted device sizes. The mean size of implanted devices was 27.1 ± 3.7 mm. The perimeter-derived diameter predicted device size most accurately (mean error = − 0.8 ± 2.4 mm). All other parameters showed significantly larger error (mean error; minimal diameter = − 4.9 ± 3.3 mm, maximal diameter = 1.0 ± 2.9 mm, average diameter = − 1.6 ± 2.6 mm, area-derived diameter = − 2.0 ± 2.6 mm) than the perimeter-derived diameter (all p for difference < 0.05). The error for other parameters were larger in cases with more eccentrically-shaped landing zones, while the perimeter-derived diameter had minor error regardless of eccentricity. When oversizing was used, all parameters showed significant disagreement. The perimeter-derived diameter on cardiac CT images provided the most accurate estimation of LAAO device size regardless of landing zone eccentricity. Oversizing was unnecessary when using cardiac CT to predict an accurate LAAO size.

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Midterm follow‐up after computed tomography angiography planned left atrial appendage closure

Rana,

Yoon,

Dallan

et al. 2023

Cathet Cardio Intervent

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BackgroundWhile studies have shown the advantages of computed tomography angiography (CTA) over transesophageal echocardiography (TEE) in left atrial appendage closure (LAAC) preprocedural planning for WATCHMAN™ legacy and FLX devices, there has been no reported long‐term data for this approach.ObjectivesWe sought to evaluate long‐term outcomes using CTA‐based preprocedural planning for LAAC using the WATCHMAN™ device.MethodsA prospective analysis of 231 consecutive patients who underwent LAAC in a single, large academic hospital in the United States was conducted over a 5‐year period. CTA‐guided preprocedural planning was performed in all. Procedural success, adverse events, length of procedure, number of devices used, and length of stay were evaluated. Rates of death, cerebral embolism, systemic embolism, and major and minor bleeding were recorded. Adjusted predicted stroke and major bleeding rates were derived from CHA2DS2‐Vasc and HAS‐BLED scores, respectively.ResultsFrom January 26, 2017, to November 23, 2021, 231 patients underwent LAAC with CTA preprocedural planning by two operating physicians. The mean age of patients was 76.5 ± 8.4. 59.7% of patients were male. Mean CHA2DS2VASc and HAS‐BLED scores were 4.5 ± 1.4 and 3.9 ± 0.9, respectively. All procedures were performed with intracardiac echo (100%). The procedural success rate was 99.1%. The CTA sizing strategy accurately predicted the implant size in 93.5% of patients. Mean number of devices used was 1.10 ± 0.3. Peri‐procedural complication rate was 2.2%. 6 patients were lost to follow‐up. Mean follow‐up was 608.94 days with a total of 377.04 patient years. Median follow‐up period of 368 days (interquartile range: 209–1067 days). There were 51 deaths from all causes (13.52 per 100 patient‐years), 10 cases of cerebral embolism (2.65 per 100 patient‐years), 2 cases of systemic embolism (0.53 per 100 patient‐years), 17 cases of major bleeding (4.50 per 100 patient‐years), and 31 cases of minor bleeding (8.2 per 100 patient‐years). All‐cause mortality at 1, 2, and 3 years was 12.7%, 20.9%, and 29.2%, respectively. CV event rates at 1, 2, and 3 years were 2.1%, 6.6%, and 10.5%, respectively.ConclusionsCTA‐based preprocedural planning is accurate in predicting device size for LAAC and associated with excellent clinical outcomes at 5 years.

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A New WATCHMAN Sizing Algorithm Utilizing Cardiac CTA

Cited by 9 publications

References 14 publications

Novel computed tomography angiography‐based sizing methodology for WATCHMAN FLX device in left atrial appendage closure

Novel computed tomography angiography‐based sizing methodology for WATCHMAN FLX device in left atrial appendage closure

Pre-procedural determination of device size in left atrial appendage occlusion using three-dimensional cardiac computed tomography

Midterm follow‐up after computed tomography angiography planned left atrial appendage closure

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