Key result
Prospective use of 3D-printed left atrial models for LAAO simulation significantly reduced the incidence of peri-device leaks compared to conventional imaging alone (5% vs. 27%, p<0.01).
Why the study?
Does prospective 3D-printed LA model simulation improve procedural outcomes and reduce peri-device leaks in patients undergoing LAAO compared to conventional imaging?
Observational (n=76)
Blinded to implanted device size (Group 1)
Does prospective 3D-printed LA model simulation improve procedural outcomes and reduce peri-device leaks in patients undergoing LAAO compared to conventional imaging?
Absolute Event Rate: 5% vs 27%
p-value: p=<0.01
3D-printed patient-specific LA models for LAAO simulation significantly improve device sizing, reduce peri-device leaks, and decrease procedure time and radiation exposure.
May aid LAAO planning to minimize leaks; hypothesis-generating and warrants randomized confirmation.
AIMS: The aim of this study was to assess the predictive value of simulation based on 3D-printed models before left atrial appendage occlusion (LAAO) for peri-device leaks (PDL) and the impact on procedural outcomes compared to conventional imaging. METHODS AND RESULTS: Seventy-six patients referred for LAAO with double disc device underwent construction of a 3D-printed LA model using flexible photopolymer resin. An implant simulation was performed retrospectively in Group 1 (55 patients), blinded to implanted device size, and prospectively in Group 2 (21 patients). In Group 1, an off-axis device position occurred in 14 patients (25%) and the incidence of PDL was 27% (15 patients); mismatch between model and device size was the best predictor (area under the curve 0.88, CI: 0.77-0.99). When using 3D simulation prospectively, mean prosthesis number per patient (1.05±0.21 vs. 1.20±0.52, p=0.04) and incidence of leaks (5% vs. 27%, p<0.01) were reduced compared to conventional imaging alone, as well as fluoroscopy time (19 mins [13.4-23] vs. 13.5 mins [11.1-15], p=0.012) and total fluoroscopy dose (7,291 [1,811-12,734] vs. 1,978 (1,548-4,800) mGy·cm2, p=0.029). CONCLUSIONS: 3D-printed patient-specific adaptive and flexible LA models improve LAAO double disc device sizing. This can potentially reduce procedure time and the number of prostheses employed per patient.
No takes yet. Share an insight, caveat, or question.
Ciobotaru et al. (2018) conducted an observational in Patients referred for LAAO (n=76). 3D-printed LA model simulation vs. Conventional imaging alone was evaluated on Incidence of peri-device leaks (PDL) (p=<0.01). Prospective use of 3D-printed left atrial models for LAAO simulation significantly reduced the incidence of peri-device leaks compared to conventional imaging alone (5% vs. 27%, p<0.01).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: