Device Size Selection Research Articles

Three‐dimensional transesophageal echocardiography measurements of ASD sizing parameters in comparison to balloon sizing method in percutaneous ASD closure

AbstractBackgroundBalloon sizing (BS) has been used for device size selection in percutaneous atrial septal defect (ASD) closure. Due to its limitations, alternative imaging techniques like three‐dimensional transesophageal echocardiography (3D‐TEE) are valuable for guiding ASD device size selection during ASD closure procedures. The purpose of this study was to compare ASD sizing using measurements obtained from 3D–TEE to those utilizing the standard balloon sizing method.MethodsWe identified 53 patients with single secundum type ASD without PFO who underwent percutaneous closure at the Tehran Heart Center between 2019 and 2022. Balloon sizing was performed in all patients with the stop‐flow technique, and the choice of device size was determined based on the sizing derived from BS. 3D‐TEE imaging was performed before the intervention, and the ASD shape and quality of ASD rims were assessed.ResultsAmong the 53 patients who underwent single ASD device closure, multiple 3D TEE measurements significantly correlated with balloon sizing results. This included defect area, perimeter, and diameter obtained from 3D‐TEE images multi‐planar reconstruction. ASD perimeter detected by 3D TEE had the best correlation with BS results. When divided by the shape of ASD, there was no significant difference between our 3D‐images data and BS in round or oval‐shaped ASDs.ConclusionThe 3D‐TEE study is reliable for assessing ASD configurational characteristics in percutaneous device closure candidates. 3D‐TEE has the potential to accurately determine the appropriate device size and reduce complications, costs, and procedural duration. Further research is needed to validate these findings and establish the role of 3D‐TEE measurements in guiding the best treatment decisions for ASD closure.

Reliability-Oriented Asymmetric Power Device Size Selection of Neutral-Point Clamped Inverter Considering Mission Profiles

Reliability-Oriented Asymmetric Power Device Size Selection of Neutral-Point Clamped Inverter Considering Mission Profiles

Abstract 17264: PFO Cover Index by 3D-TEE Predicts Residual Shunting After Transcatheter Closure

Introduction: Proper defect sizing and device size selection are imperative for ensuring successful clinical outcomes after transcatheter patent foramen ovale (PFO) closure. However, with current sizing techniques, residual shunting remains as high as 25% and is associated with an increased risk of recurrent neurologic events. Since 2017, we adopted a PFO sizing strategy based on right atrial (RA) tunnel “width” oversizing utilizing three-dimensional transesophageal echocardiography (3D-TEE). Hypothesis: We hypothesized that the PFO tunnel width at the RA opening and a cover index based on this dimension would predict residual shunting at long term follow-up. Methods: Sixty-four patients underwent transcatheter PFO closure (60 patients utilizing a 3D-TEE based oversizing strategy) at our institution between 2015 and 2022. PFO tunnel length, tunnel width at RA opening, and tunnel width at left atrial opening were determined by 3D-TEE either before or at the time of closure. We determined an absolute PFO “cover index” for each patient as follows: RA disc diameter - RA tunnel width. Receiver operating characteristic (ROC) curve analysis was used to determine the predictive ability of 3D-TEE derived PFO dimensions and the PFO cover index to predict residual shunting at follow-up. Results: Fifty-one of sixty-four patients had a long-term follow-up bubble study (mean follow-up time 8.0±3.7 months). Of the 47 patients closed utilizing a 3D-TEE based sizing strategy and with a follow-up bubble study, only 5 patients (10.6%) had residual shunting at follow-up. Of the three 3D-TEE based PFO dimensions, only the RA tunnel width was predictive of residual shunting at follow-up (AUC 0.84, p=0.004). A cutoff of 15.5 mm or greater for RA tunnel width had the best combination of sensitivity (86%) and specificity (73%). The PFO cover index was also strongly predictive of residual shunting at follow-up (AUC 0.87, p=0.002). A cutoff of 9.5 mm or less had the best combination of sensitivity (86%) and specificity (82%). Conclusions: A larger PFO tunnel width at the right atrial opening and a lower cover index based on this dimension predict residual shunting at follow-up. Our findings have important implications for improving sizing strategies for transcatheter PFO closure.

Virtual implantation of Derivo Embolization Devices using PreSize Neurovascular software: Accuracy evaluation and size selection comparison study.

Evaluating the deployed length of flow diverting stents (FDs) to select the optimal device size remains a challenging, yet crucial, task in aneurysm treatment. This study reports on the accuracy of PreSize Neurovascular (Oxford Heartbeat Ltd), a visualization and simulation software for FD intervention planning, in predicting FD deployed length, and on its impact on device size selection. Imaging data from consecutive patients treated with Derivo Embolization Device (Acandis GmbH) were collected from University Medical Center Hamburg-Eppendorf and retrospectively analyzed. Accuracy evaluation: prediction accuracy was calculated by comparing deployed FD lengths measured from imaging data and simulated by PreSize. Size selection comparison: two Interventional Neuroradiologists (INR1, INR2), blinded to the devices deployed, used PreSize to select the optimal device size (diameter and length). Their choices were compared against the deployed devices selected by conventional planning. Among 98 implanted devices, PreSize predicted deployed FD length with a mean accuracy of 94.54% (95% confidence interval [93.72%, 95.35%]). Among 98 aneurysm cases, PreSize-informed device lengths were significantly shorter (Wilcoxon signed-rank test, INR1: W = 394, P < .001, INR2: W = 305, P < .001) by 4.13 and 4.18 mm on average, and up to 20 and 25 mm, for INR1 and INR2, respectively, than the conventionally selected FDs. In 32% of cases, PreSize-informed devices resulted in fewer vessel bends covered by the FD while achieving sufficient aneurysm coverage. PreSize retrospectively predicted deployed FD lengths with high accuracy. Moreover, INRs in this study were more inclined to select shorter stent length in the simulation than they would have done conventionally.

Computational fluid dynamics comparison of the upper airway velocity, pressure, and resistance in cats using an endotracheal tube or a supraglottic airway device.

In veterinary medicine, airway management of cats under general anesthesia is performed with an endotracheal tube (ETT) or supraglottic airway device (SGAD). This study aims to describe the use of computational fluid dynamics (CFD) to assess the velocities, pressures, and resistances of cats with ETT or SGAD. A geometrical reconstruction model of the device, trachea, and lobar bronchi was carried out from computed tomography (CT) scans that include the head, neck, and thorax. Twenty CT scans of cats under general anesthesia using ETT (n = 10) and SGAD (n = 10) were modeled and analyzed. An inspiratory flow of 2.4 L/min was imposed in each model and velocity (m/s), general and regional pressures (cmH2O) were computed. General resistance (cmH2O/L/min) was calculated using differential pressure differences between the device inlet and lobar bronchi. Additionally, regional resistances were calculated at the device's connection with the breathing circuit (region A), at the glottis area for the SGAD, and the area of the ETT exit (bevel) (region B) and the device itself (region C). Recirculatory flow and high velocities were found at the ETT's bevel and at the glottis level in the SGAD group. The pressure gradient (Δp) was more enhanced in the ETT cases compared with the SGAD cases, where the pressure change was drastic. In region A, the Δp was higher in the ETT group, while in regions B and C, it was higher in the SGAD group. The general resistance was not statistically significant between groups (p = 0.48). Higher resistances were found at the region A (p = <0.001) in the ETT group. In contrast, the resistance was higher in the SGAD cases at the region B (p = 0.001). Overall, the provided CT-based CFD analysis demonstrated regional changes in airway pressure and resistance between ETT and SGAD during anesthetic flow conditions. Correct selection of the airway device size is recommended to avoid upper airway obstruction or changes in flow parameters.

3D intracardiac echocardiography for left atrial appendage sizing and percutaneous occlusion guidance

Abstract Funding Acknowledgements Type of funding sources: None. Background Left atrial appendage (LAA) imaging is critical during percutaneous occlusion procedures. 3D-intracardiac echocardiography (ICE) features direct visualization of LAA from multiple cross-sectional planes at a time. Purpose To report procedural success of 3D-ICE-guided LAA occlusion and the correlation between pre-procedural transesophageal echocardiography (TEE) and intraprocedural 3D-ICE for LAA sizing. Methods Among 274 patients undergoing LAAO, periprocedural ICE guidance was achieved via a commercially available 2D-ICE catheter (220 patients) or a novel 3D-ICE one (54 patients; Fig.1). Primary endpoint was a composite of procedural success and LAA sealing at follow-up TEE. Secondary endpoint was a composite of periprocedural device recapture/resizing plus presence of leaks≥3mm at follow-up TEE. Results 3D-ICE measurements of maximum landing zone correlated highly with preprocedural TEE reference values [Pearson’s: 0.94; p&amp;lt;0.001; bias: -0.06 (-2.39, 2.27)] (Fig.2). The agreement between 3D-ICE-based device selection and final device size was 96.3% versus 79.1% with 2D-ICE (p=0.005). The incidence of the primary endpoint was 98.1% with 3D-ICE and 97.3% with 2D-ICE (p=0.99). 2D-ICE patients had a trend towards a higher incidence of periprocedural device recapture/redeployment (31.5% vs 44.5%; p=0.09). The secondary endpoint occurred in 31.5% of 3D-ICE patients versus 45.9% of 2D-ICE ones (p=0.065). Conclusions ICE-guided LAAO showed a very high success, with no major adverse events. A very high level of agreement for LAA sizing was found between pre-procedural TEE and periprocedural 3D-ICE. 3D-ICE performed significantly better than 2D-ICE for device size selection and may provide better guidance during device deployment.

A 2-V 1.4-dB NF GaAs MMIC LNA for K-Band Applications.

A 1.4-dB Noise Figure (NF) four-stage K-band Monolithic Microwave Integrated Circuit (MMIC) Low-Noise Amplifier (LNA) in UMS 100 nm GaAs pHEMT technology is presented. The proposed circuit is designed to cover the 5G New Release n258 frequency band (24.25-27.58 GHz). Momentum EM post-layout simulations reveal the circuit achieves a minimum NF of 1.3 dB, a maximum gain of 34 dB, |S11| better than -10 dB from 23 GHz to 29 GHz, a P1dB of -18 dBm and an OIP3 of 24.5 dBm. The LNA draws a total current of 59.1 mA from a 2 V DC supply and results in a chip size of 3300 × 1800 µm2 including pads. We present a design methodology focused on the selection of the active device size and DC bias conditions to obtain the lowest NF when source degeneration is applied. The design procedure ensures a minimum NF design by selecting a device which facilitates a simple input matching network implementation and obtains a reasonable input return loss thanks to the application of source degeneration. With this approach the input matching network is implemented with a shunt stub and a transmission line, therefore minimizing the contribution to the NF achieved by the first stage. Comparisons with similar works demonstrate the developed circuit is very competitive with most of the state-of-the-art solutions.

Assessment of atrial septal defects using 3-dimensional transthoracic echocardiography prior to percutaneous device closure: first report from Bangladesh.

Secundum atrial septal defect (ASD) is treated following trans-catheter closure in alternative to surgical treatment. Per-intervention selection of device size with balloon occlusive diameter (BOD) often cause tearing or enlarging, causing arrhythmias and hypotension. We assessed the suitability of percutaneous device closure for ASD using 3-dimensional transthoracic echocardiography (3DTTE). This study was conducted to investigate if 3DTTE could be an alternative of balloon sizing for selection of device size in atrial septal defect device closure. It was a cross-sectional comparative study. This study was conducted at the department of Pediatric Cardiology, Bangabandhu Sheikh Mujib Medical University for a period of 2 years. Thirty-three purposively selected secundum ASD patients suitable for device closure were included in the study. Ethical permission was taken from the Institutional Review Board and written consent was taken from each patient's guardian. In this study, 3DTTE derived ASD diameter and BOD were compared with that of deployed device size using correlation analysis. Out of 33 patients, 63.6% were female and 36.4% were males had a mean age of 18.07 ± 14.58 years (range 2-55 years). Mean diameter of ASD measured by 2-dimensional (2D) and 3-dimensional (3D) echocardiography were 17.09 ± 6.08 mm and 21.30 ± 6.56 mm, respectively, yielding a significant difference (p < 0.001). 3D echocardiography derived ASDs diameter were highly correlated with device size than BOD and 2D echocardiography derived diameter (2D echocardiography: r = 0.796, p = <0.001, 3D echocardiography: r = 0.960, p = <0.001, BOD: r = 0.840, p = <0.001). 3DTTE can accurately measure ASD diameter and can be used as an alternate, effective, and safe method to select device size.

Does a Change in Device Design Alter Device Size Selection? A Comparison of Conventional and Occlutech Duct Occluder Designs.

The Occlutech duct occluder (ODO) with a novel design has been available for closure of patent ductus arteriosus (PDA) since 2011. Available data on initial experience with the ODO have shown that operators continue to choose device sizes based on their experience with conventional duct occluders (CDO). This study postulated that occlusion of the pulmonary arterial (PA) end of the ductus should achieve satisfactory PDA closure without additional complications. Accordingly, the size of the ODO was chosen such that the larger PA diameter in the new design exceeded the PA end of the ductus by 2-3 mm and 2-4 mm for normotensive and hypertensive ducts, respectively. It sought to examine the feasibility and safety of such an approach, and compared ODO and CDO devices with respect to device sizes deployed, to ascertain if the newer design had any advantages. This prospective study enrolled 105 infants, children and a few adults with various duct morphologies and PA pressures for ductal closure using the ODO from 2018-2020. The control group consisted of 105 ducts closed with CDO. A comparison of the two groups with respect to duct diameter and implanted device sizes was performed using appropriate statistical software. The study found that 40% of the ducts had moderate-to-severe pulmonary hypertension. Most ducts measured between 3-4 mm in both groups. The mean weight of the subjects in both groups was 12 kg. Although there was no change in the way that duct occluders were chosen in both groups (2-3 mm over the pulmonary artery diameter), ODO could be significantly downsized in most ducts measuring between 2.5-6.4 mm in diameter (p<0.05). This study found successful closure of relatively larger PDA in infants and children using smaller ODO compared with CDO, without embolisation or aortic narrowing. It also demonstrated that a different device size selection technique may be safely employed with the ODO.

Efficacy and utilization of intravascular ultrasound in office-based lower extremity endovascular interventions for peripheral arterial disease.

Intravascular ultrasound (IVUS) is a uniquely objective but underutilized imaging modality in the interventional treatment of peripheral arterial disease treatment. IVUS has been shown to improve device size selection and diagnose occult pathology difficult to see with routine angiography. We hypothesize that the use of IVUS in lower extremity endovascular intervention improves accuracy in stent and balloon size selection and minimizes contrast use. This is a retrospective case series performed at a single-institution outpatient center by two vascular surgeons from July 2016 through July 2017. We identified 94 total IVUS-assisted procedures. We collected data regarding demographics, balloon and stent size, IVUS-determined vessel diameter, pre-procedure and post-procedure ABI values, and contrast used during the procedure. An independent core laboratory was further utilized to characterize all IVUS and angiographic size vessel measurements. For the 94 lower extremity IVUS-assisted interventions, the average patient age was 70±9 years old, with an average contrast use of 37.1mL of Omnipaque 300. There was substantial improvement in pre- and post-procedure ABI (0.7±0.23 to 0.94±0.21). On analysis of average intraluminal IVUS vessel diameter to balloon angioplasty used, we had a correlation in size of 0.96±0.16 in our series. Additionally, in eight instances IVUS allowed for identification of a flow-limiting dissection with subsequent stenting. Routine use of IVUS offers a powerful diagnostic paradigm that has the potential to significantly decrease contrast use and to improve objectivity in choosing appropriate vascular tools to maximize intra-procedural efficacy. The discovery of adverse findings not initially noticed on angiography further reinforces the value of IVUS utilization.

Simulation of intra-saccular devices for pre-operative device size selection: Method and validation for sizing and porosity simulation

Intra-saccular devices (ID) are novel braided devices used for complex intracranial aneurysms treatment. Treatment success is associated with correct device size selection. A technique that predicts the ID size within the aneurysm before intervention will provide a powerful computational tool to aid the interventionist during device selection. We present a method to calculate the device’s final height, radial expansion and porosity within the patient’s anatomy, which allows assessing different device sizes before treatment takes place. The proposed sizing technique was tested in-vitro and in real patient’s geometries obtained from 3DRA angiographic images of 8 unruptured aneurysms previously treated with IDs. The obtained simulated height was compared to the real height, with a mean error of less than 0.28 mm (±0.44). The porosity calculation method was tested in-vitro with an error of 0.02 (±0.022). The results of both sizing and porosity experiments resemble well measures from real patients. This methodology could be used before treatment to provide the interventionist with additional information that allows selecting the device that best fits the patient’s aneurysm to be treated.

The Woven EndoBridge (WEB) device: feasibility, techniques, and outcomes after FDA approval.

Wide-neck bifurcation cerebral aneurysms have historically required either clip ligation or stent- or balloon-assisted coil embolization. This predicament led to the development of the Woven EndoBridge (WEB) aneurysm embolization system, a self-expanding mesh device that achieves intrasaccular flow disruption and does not require antithrombotic medications. The authors report their operative experience and 6-month follow-up occlusion outcomes with the first 115 aneurysms they treated via WEB embolization. The authors reviewed the first 115 cerebral aneurysms they treated by WEB embolization after FDA approval of the WEB embolization device (from February 2019 to January 2021). Data were collected on patient demographics and clinical presentation, aneurysm characteristics, procedural details, postembolization angiographic contrast stasis, and functional outcomes. A total of 110 patients and 115 aneurysms were included in our study (34 ruptured and 81 unruptured aneurysms). WEB embolization was successful in 106 (92.2%) aneurysms, with a complication occurring in 6 (5.5%) patients. Contrast clearance was seen in the arterial phase in 14 (12.2%) aneurysms, in the capillary phase in 16 (13.9%), in the venous phase in 63 (54.8%), and no contrast was seen in 13 (11.3%) of the aneurysms studied. Follow-up angiography was performed on 60 (52.6%) of the aneurysms, with complete occlusion in 38 (63.3%), neck remnant in 14 (23.3%), and aneurysmal remnant in 8 (13.3%). Six (5.5%) patients required re-treatment for persistent aneurysmal residual on follow-up angiography. The WEB device has been successfully used for the treatment of both unruptured and ruptured wide-neck bifurcation aneurysms by achieving intrasaccular flow diversion. Here, the authors have shared their experience with its unique technical considerations and device size selection, as well as critically reviewed complications and aneurysm occlusion rates.

Transcatheter aortic valve replacement: impact of pre-procedural FEops HEARTguide assessment on device size selection in borderline annulus size cases.

ObjectivesThe aim of this study is to evaluate device size selection in patients within the borderline annulus size range undergoing transcatheter aortic valve replacement (TAVR) and to assess if pre-procedural patient-specific computer simulation will lead to the selection of a different device size than standard of care.BackgroundIn TAVR, appropriate device sizing is imperative. In borderline annulus size cases no standardised technique for tailored device size selection is currently available. Pre-procedural patient-specific computer simulation can be used, predicting the risk for paravalvular leakage (PVL) and need for permanent pacemaker implantation (PPI).MethodsIn this multicentre retrospective study, 140 patients in the borderline annulus size range were included. Hereafter, device size selection was left to the discretion of the operator. After TAVR, in 24 of the 140 patients, patient-specific computer simulation calculated the most appropriate device size expected to give the lowest risk for PVL and need for PPI. In these 24 patients, device size selection based on patient-specific computer simulation was compared with standard-of-care device size selection relying on a standardised matrix (Medtronic).ResultsIn a significant proportion of the 140 patients (26.4%) a different device size than recommended by the matrix was implanted. In 10 of the 24 patients (41.7%) in whom a computer simulation was performed, a different device size was recommended than by means of the matrix.ConclusionsDevice size selection in patients within the borderline annulus size range is still ambiguous. In these patients, patient-specific computer simulation is feasible and can contribute to a more tailored device size selection.

Clinical Impact of Preprocedural CT-Based 3D Computational Simulation of Left Atrial Appendage Occlusion with Amulet.

Aims Standard of care (SoC) device size selection with transoesophageal echocardiography (TOE) and computed tomography (CT) in LAAO can be challenging due to a certain degree of variability at both patient and device levels. The aim of this study was to prospectively evaluate the clinical impact of 3D computational modelling software in the decision-making of left atrial appendage occlusion (LAAO) with Amplatzer Amulet. Methods and Results SoC preprocedural assessments as well as CT-based 3D computational simulations (FEops) were performed in 15 consecutive patients scheduled for LAAO with Amulet. Preprocedural device size selection and degree of confidence were determined after SoC and after FEops-based assessments and compared to the implanted device. FEops-based preprocedural assessment correctly selected the implanted device size in 11 out of 15 patients (73.3%), compared to 7 patients (46.7%) for SoC-based assessment. In 4 patients (26.7%), FEops induced a change in device size initially selected by SoC. In the 7 patients (46.7%) in which FEops confirmed the SoC device size selection, the degree of confidence of the size selection increased from 6.4 ± 1.4 for SoC to 8.1 ± 0.7 for FEops. One patient (6.7%) could not be implanted for anatomical reason, as correctly identified by FEops. Conclusions Preprocedural 3D computational simulation by FEops impacts Amulet size selection in LAAO compared to TOE and CT-based SoC assessment. Operators could consider FEops computational simulation in their preprocedural device size selection.

Optimal Woven EndoBridge (WEB) Device Size Selection Using Automated Volumetric Software.

Introduction: Selecting the appropriate Woven EndoBridge (WEB) device sizing for the treatment of wide-neck bifurcation aneurysms (WNBAs) remains challenging. The aim of this study was to evaluate different volumetric-based imaging methodologies to predict an accurate WEB device size selection to result in a successful implantation. Methods: All consecutive patients treated with WEB devices for intracranial aneurysms from January 2019 to June 2020 were included. Aneurysm dimensions to calculate aneurysm volumes were measured using three different modalities: automated three-dimensional (3D) digital subtraction angiography (DSA), manual 3D DSA, and two-dimensional (2D) DSA. The device–aneurysm volume (DAV) ratio was defined as device volume divided by the aneurysm volume. WEB volumes and the DAV ratios were used for assessing the device implantation success and follow-up angiographic outcomes at six months. Pearson correlation, Wilcoxon Rank Sum test, and density approximations were used for estimating the WEB volumes and the imaging modality volumes for successful implantation. Results: A total of 41 patients with 43 aneurysms were included in the study. WEB device and aneurysm volume correlation coefficient was highest for 3D automatic (r = 0.943), followed by 3D manual (r = 0.919), and 2D DSA (r = 0.882) measurements. Measured median volumes were significantly different for 3D automatic and 2D DSA (p = 0.017). The highest rate of successful implantation (87.5%) was between 0.6 and 0.8 DAV ratio. Conclusion: Pre-procedural assessment of DAV ratios may increase WEB device implantation success. Our results suggest that volumetric measurements, especially using automated 3D volumes of the aneurysms, can assist in accurate WEB device size selection.

Device size selection can enhance Y-stentrieving efficacy and safety as a rescue strategy in stroke thrombectomy

BackgroundDespite advancements in stroke treatment, refractory clots are relatively common, prompting the exploration of alternative techniques. Bifurcation occlusions pose specific intraprocedural challenges, occasionally dealt with by two stentrievers deployed in...

Echocardiographic versus Angiographic Measurement of the Patent Ductus Arteriosus in Extremely Low Birth Weight Infants and the Utility of Echo Guidance for Transcatheter Closure

Transthoracic echocardiography (TTE) is increasingly utilized for guiding transcatheter closure of patent ductus arteriosus (PDA) in extremely low birth weight (ELBW) infants. The objectives of this study were to compare PDA size measurements by TTE with angiographic measurements and to describe TTE techniques used in guiding transcatheter PDA closure (TCPC) in ELBW infants. One hundred twenty-five consecutive ELBW infants (gestational age<27weeks, birth weight<1kg) who underwent TCPC before 8weeks of age under TTE guidance were included. Patent ductus arteriosus sizes were measured from the procedural TTE and angiograms retrospectively by blinded observers. The TTE PDA diameters at the aortic (ED1) and pulmonary end (ED2) were compared with the corresponding angiographic diameters (CD1 and CD2). The TTE PDA lengths, obtained by two techniques (EL1, a straight line between ED1 and ED2; and EL2, a curvilinear line along the PDA), were compared with the PDA length by angiography (CL). Transthoracic echocardiography was used to guide accurate device positioning within the PDA. The procedure weight was 600-1,460g. The TTE and angiographic PDA diameters were comparable (mean ED1 vs CD1=4.5±0.68 vs 4.4±0.85mm, P=.26; and mean ED2 vs CD2=3.1±0.72 vs 3.2±0.94mm, P=.14). The angiographic length was underestimated by EL1 by 2.6±1.6mm(P<.0001), while EL2 estimated it better (mean EL2 vs CL=11.0±1.83 vs 10.8±2.15mm; P=.40). Transcatheter PDA closure was successful in 100% of the cases using TTE guidance. There were no intraprocedural complications. Transthoracic echocardiography guidance during TCPC in ELBW infants eliminates the need for aortograms via femoral arterial access, preventing the complications associated with it. Transthoracic echocardiography PDA measurements are comparable to angiographic measurements, thereby assisting in appropriate device size selection.

Volume-based sizing of the Woven EndoBridge (WEB) device: A preliminary assessment of a novel method for device size selection.

Accurate sizing of the Woven EndoBridge (WEB) device is of critical importance as it determines procedural safety and successful occlusion of wide neck bifurcation aneurysms. The aim of this study was to assess the ability of aneurysm volume to assist in accurate WEB size selection. All patients with an intracranial aneurysm treated with the WEB SL or WEB SLS device between March 2019 and October 2019 were identified for this retrospective study. Aneurysm volumes were calculated with auto-segmentation using a three-dimensional volume rendering program on an independent Syngo workstation (Siemens Healthineers AG). Pearson correlation coefficients were calculated for aneurysm auto-segmented volumes and WEB volumes, as well as for aneurysm height × width and WEB height × width. Follow-up angiographic outcomes were collected at 6-9 months post-procedure. Twenty-nine aneurysms were evaluated by 3D rotational angiography. The correlation coefficient with WEB size was larger for auto-segmented aneurysm volumes (r = 0.979) compared to height × width measurements (r = 0.867). Using Fisher r-to-z transformations, we found the difference between the two correlations to be statistically significant (p = 0.0007). Follow-up angiography available in 13 subjects demonstrated an 85% complete aneurysm occlusion rate. Aneurysm volumes are highly correlated with WEB volumes, with auto-segmentation volumes displaying statistically significant difference against conventional height by width measurements. These results suggest that volumetric measurements of aneurysm size provide a useful adjuvant measure to assist in appropriate size selection of the WEB device.

Safety and effects of volume loading during transesophageal echocardiography in the pre-procedural work-up for left atrial appendage closure

BackgroundIn patients undergoing left atrial appendage (LAA) closure, an accurate sizing of the LAA is key to optimize device sizing, procedural success and reduce complications. Previous studies have shown that intraprocedural volume loading increases LAA dimensions and improves device sizing. However, the safety and effects on LAA and device sizing of administering a fluid bolus during pre-procedural transesophageal echocardiography (TEE) are unknown. The aim of this study was to determine the safety and impact on LAA dimensions and device sizing of an intravenous (IV) fluid bolus administered during TEE in the setting of the pre-procedural work-up for LAA closure.MethodsThe study included a total of 72 patients who underwent TEE to assess suitability for LAAC and received a 500 ml IV bolus of normal saline. The LAA landing zone (LZ) and depth were measured by TEE before and after volume loading, and these measurements were used to predict the device size implanted during a subsequent percutaneous LAAC procedure.ResultsThere were no complications associated with volume loading. The baseline mean LZ was 19.6 ± 3.6 mm at 90o, and 20.2 ± 4.1 mm at 135o. Following fluid bolus, the maximum diameter increased 1.5 ± 1.0 mm at 90o (p<0.001), and 1.3 ± 1.0 mm at 135o (p<0.001). The baseline mean depth of the LAA was 26.5 ± 5.5 mm at 90o, and 23.9 ± 5.8 mm at 135o. After fluid bolus, the mean depth increased by 1.5 ± 1.8 mm (p<0.001) and 1.6 ± 2.0 (p<0.001), at 90o and 135o, respectively. Sizing based on post-bolus measurements of the LZ significantly improved the agreement with the final device size selection during the procedure in 71.0% of cases (vs. 42.0% with pre-bolus measurements).ConclusionsVolume loading during ambulatory TEE as part of the pre-procedural work-up of LAAC is safe and significantly increases LAA dimensions. This strategy may become the new standard, particularly in centers performing LAAC with no TEE guidance, as it improves LAA sizing and more accurately predicts the final device size.

Personalized Fluoroscopic Angles in Watchman™ Left Atrial Appendage Closure Landing Zone Assessment: A Three-Dimensional Printed Simulation Study.

BackgroundAtrial fibrillation causes ischemic stroke when thrombi dislodge from a cardiac outpouching, the left atrial appendage (LAA), and embolize to the brain. LAA occlusion with the Watchman™ device (Boston Scientific Corporation, MA, USA), which prevents stroke, requires accurate LAA measurements for device sizing. We explore whether standard fluoroscopic LAA measurements improve when obtained at CT-derived viewing angles personalized to LAA anatomy while concurrently referring to three-dimensional (3D) CT.MethodsLeft atrial 3D reconstructions created from contrast CT (n=28) were analysed to identify personalized viewing angles wherein LAA dimensions (LAA maximum landing zone diameter and LAA length) were best observed. The 3D-CT reconstructions were then 3D printed with stands. Fluoroscopy of anatomically oriented models in the catheter lab simulated LAA angiography. Fluoroscopic images were acquired at standard (caudal 20˚/right anterior oblique 30˚) and personalized viewing angles. Repeated measurements of LAA dimensions were taken from CT (Control), fluoroscopy at standard angles (Standard), personalized angles (Blinded), and personalized angles while concurrently referring to 3D CT (Referred).ResultsControl measurements correlated and agreed better with Referred and Blinded measurements than with Standard measurements (diameter correlation and agreement: Control/Standard r=.554, limits of agreement [LOAs]=6.83/-5.91; Control/Blinded r=.641, LOA =5.67/-5.54; Control/Referred r=.741, LOA=4.69/-4.14; length correlation and agreement: Control/Standard rs=.829, LOA=9.61/-3.02; Control/Blinded rs=0.789, LOA=7.13/-4.94; Control/Referred rs=.907, LOA=4.84/-4.13). Personalized angles resulted in hypothetical device size predictions more consistent with Control (device size correlation: Control/Standard rs=.698, Control/Blinded rs=.731, Control/Referred rs=.893, P<0.001). False ineligibility rates were Standard=6/28, Blinded=6/28, and Referred=2/28.ConclusionThis simulation suggests that personalized fluoroscopic viewing angles with in-procedural reference to 3D CT may improve the accuracy of LAA maximum landing zone diameter and length measurements at the Watchman landing zone. This improvement may result in more consistent device size selection and procedural eligibility assessment. Further clinical research on these interventions is merited.