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

Abstract

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.

Cardiac magnetic resonance imaging for left atrial appendage closure planning

“…(Watchman FLX), mean 1.0 devices/case and 100% procedural success rate using preoperative CMR with intraoperative ICE in a 10 patient series by Dallan et al. (Watchman FLX and Amulet), this study demonstrated similar outcomes with mean 1.2 devices/case and 96% procedural success rate using preoperative CMR with intraoperative TEE and/or ICE (Watchman FLX and Amulet) 6,18,19 . Overall, the use of preoperative CMR in this study resulted in an acceptable procedural success rate both immediately and on short‐term follow‐up.…”

“…17 procedural success rate using preoperative CMR with intraoperative TEE and/or ICE (Watchman FLX and Amulet). 6,18,19 Overall, the use of preoperative CMR in this study resulted in an acceptable procedural success rate both immediately and on short-term follow-up.…”

Computer simulations to improve reality: A novel paradigm for interventional procedure planning

“…In this issue of the Journal, Hokken et al 3 provide clinical evidence that CT‐derived computer simulation can improve TAVR outcomes. In a multicenter, prospective observational study of TAVR in patients with challenging anatomy, they found that the HEARTguide computer simulation software (FEops) changed the procedural plan in 35% of patients, including changes in valve size and target implantation depth.…”

“…The TruPlan simulation software for WATCHMAN FLX procedure planning (Boston Scientific) has been shown to reduce the number of deployment attempts as well as the risk of peri-procedural adverse events. 3 Additionally, intracardiac echocardiography (ICE) imaging guidance for LAAO has become more Expert Article Analysis for: Clinical value of CT-derived simulations of transcatheter-aortic-valve-implantation in challenging anatomies the PRECISE-TAVI trial…”

Fusion technology utilization in percutaneous left atrial appendage occlusion outcome

“…2 Planning for LAAO procedure includes utilization of cardiac imaging including transesophageal echocardiography (TEE), cardiac computed tomography angiography (CCTA), and cardiac magnetic resonance imaging to rule out LAA thrombus, LAA sizing, and defining the optimal transseptal access and landing zone of LAAO. 3,4 3-D CCTA will define the complex anatomy LAA anatomy than TEE or intracardiac echocardiogram (ICE) including multiple lobes, hidden lobes, and acute angle of LAA neck and improve the LAAO procedure outcome. Fusion technology of integration fluoroscopy into 3D-multidetector computed tomography (3D-MDCT) has been utilized in the LAAO procedure work-flow with an improvement of the LAAO procedure outcome [5][6][7] In this issue of Journal of Cardiovascular Electrophysiology, There is a reasonable explanation for the difference between the current study and previous studies clinical and procedure outcomes of LAAO for Watchman device with 3D-MDCT fluoroscopy fusion technology.…”