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Objectives: This study aims to evaluate the safety and performance of the new embolic deflection device TriGuard™HDH in patients undergoing TAVR., Background: Transcatheter aortic valve replacement (TAVR) is associated with a high incidence of new cerebral ischemic lesions. The use of an embolic protection device may reduce the frequency of TAVR-related embolic events., Methods: This prospective, single arm feasibility pilot study included 14 patients with severe symptomatic aortic stenosis scheduled for TAVR. Cerebral diffusion weighted magnetic resonance imaging (DWI) was planned in all patients one day before and at day 4 (±2) after the procedure. Major adverse cerebral and cardiac events (MACCEs) were recorded for all patients. Primary endpoints of this study were I) device performance success defined as coverage of the aortic arch takeoffs throughout the entire TAVR procedure and II) MACCE occurrence. Secondary endpoints included the number and the volume of new cerebral ischemic lesions on DWI., Results: Thirteen patients underwent transfemoral TAVR and one patient a transapical procedure. Edwards SAPIEN valve prosthesis was implanted in 8 (57%) patients and Medtronic CoreValve prosthesis in the remaining 6 (43%). Predefined performance success of the TriGuard™HDH device was achieved in 9 (64%) patients. The composite endpoint MACCE occurred in none of the patients. Post-procedural DWI was performed in 11 patients. Comparing the DWI of these patients to a historical control group showed no reduction in number [median 5.5 vs. 5.0, P = 0.857], however there was a significant reduction in mean lesion volume per patient [median 13.8 vs. 25.1, P = 0.049]., Conclusion: This study showed the feasibility and safety of using the TriGuard™HDH for cerebral protection during TAVR. This device did not decrease the number of post-procedural new cerebral DWI lesions, however its use showed decreased lesion volume as compared to unprotected TAVR. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Aims: To compare the extent of cerebral ischemic injury after transcatheter aortic valve replacement (TAVR) with the use of an Embrella Embolic Deflector System versus unprotected TAVR., Methods: Fifteen patients with severe symptomatic aortic stenosis underwent TAVR with use of the Embrella Embolic Deflector System for cerebral protection. Cerebral diffusion-weighted magnetic resonance imaging (DWI) was performed in all patients at day 4 after the procedure and images were retrospectively compared to 37 patients who had previously undergone TAVR without a protection device (TAVR-only group)., Results: Successful placement of the Embrella device was achieved in all patients. DWI revealed an increase in the number of ischemic lesions in the Embrella group compared with the TAVR-only group (9.0 vs 5.0, P = .044). The use of the Embrella device was however associated with a significant reduction in single-lesion volume: 9.7 μL [5.8, 18.4] versus 17.8 μL [9.5, 38.7] (P < .001). Moreover, total infarct volumes of more than 1000 μL were only seen in the TAVR-only group. More lesions occurred in the right side of the brain in the Embrella group, whereas in the TAVR-only group lesions were distributed equally between left and right. One patient in the TAVR-only group suffered from a transient ischemic attack. Postoperative evaluation was clinically uneventful in the Embrella group., Conclusions: The use of the Embrella device during TAVR increased the number of cerebral ischemic lesions on postprocedural brain imaging. This increase in number was however accompanied by a significant reduction in single-lesion volume and the absence of large total infarct volumes., (Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Aims: We aimed to determine whether preprocedural analysis of multislice computed tomography (MDCT) scan could accurately predict the "line of perpendicularity" (LP) of the aortic annulus and corresponding C-arm angulations required for prosthesis delivery., Methods and Results: A 3D analysis of preprocedural MDCT dedicated to define the LP of the aortic annulus was performed in 60 consecutive patients referred for transcatheter aortic valve replacement (TAVR). In 24 patients, the analysis was performed retrospectively to evaluate reproducibility. In 11 patients of this cohort, additional fluoroscopy and MDCT were performed postprocedure to compare the LP of the aortic annulus and the LP of the implanted bioprosthesis. In 36 patients, the analysis was performed prospectively and the results were available at the time of the procedure. In those 36 patients, the postprocedure fluoroscopy-defined LP of the implanted bioprosthesis was used to validate the LP of the aortic annulus as predicted by MDCT. Intraobserver and interobserver reproducibility of the 3D analysis of MDCT to define the LP of the aortic annulus (κ = 1 and 0.94, respectively) and of the bioprosthesis (κ= 1 and 1, respectively) were excellent. Comparison between the LP of the aortic annulus and the LP of the bioprosthesis showed that the two LPs were virtually identical, demonstrating both self-centering of the device during implantation and the possibility to use the LP of the implanted bioprosthesis as a surrogate of the LP of the aortic annulus. In the prospective cohort, the ability of MDCT analysis to predict the LP of the aortic annulus was very good (accuracy = 94% and κ = 0.89)., Conclusion: Automated 3D analysis of preimplantation MDCT accurately predicts the LP of the aortic annulus and the corresponding C-arm position required for TAVR., (Copyright © 2013 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to determine whether pre-procedural analysis of multidetector row computed tomography (MDCT) scans could accurately predict the "line of perpendicularity" (LP) of the aortic annulus and corresponding C-arm angulations required for prosthesis delivery and impact the outcome of the procedure., Background: Optimal positioning of the transcatheter aortic prosthesis is paramount to transcatheter aortic valve replacement (TAVR) procedural success., Methods: All patients referred for TAVR at our center underwent a routine pre-procedural MDCT scan. A 3-dimensional (3D) analysis using software dedicated to define the LP of the aortic annulus and the corresponding C-arm positioning was performed in 71 consecutive patients. In 35 patients, the results of the MDCT analysis were not available at the time of the procedure (angiography cohort). In that cohort the position of the C-arm was determined during the procedure using ad-hoc angiography. In 36 patients, the MDCT analysis was performed pre-procedure and results were available at the time of the procedure (MDCT cohort). In that cohort the position of the C-arm was derived from the MDCT analysis rather than by ad-hoc angiography., Results: Intraobserver and interobserver reproducibility of MDCT analysis to predict the LP of the aortic annulus were excellent (kappa = 1 and 0.94, respectively). Patient variations of the LP ranged >70°. Compared with the angiography cohort, the MDCT cohort was associated with a significant decrease in implantation time (p = 0.0001), radiation exposure (p = 0.02), amount of contrast (p = 0.001), and risk of acute kidney injury (p = 0.03). Additionally, the combined rate of valve malposition and aortic regurgitation was also reduced (6% vs. 23%, p = 0.03)., Conclusions: Automated 3D analysis of pre-implantation MDCT accurately predicts the LP of the aortic annulus and the corresponding C-arm position required for TAVR. With this approach, the implantation of the balloon-expandable prosthetic valve can be performed without an aortogram in the majority of cases and still be safe, with a low rate of valve malpositioning and regurgitation., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: Moderate to severe aortic regurgitation is occurring in 20% to 30% of cases after transcatheter aortic valve implantation., Methods: The purpose of the study was to investigate the impact of a prospective policy of "oversizing" the Edwards SAPIEN bioprosthesis (Edwards Lifesciences LLC, Irvine, Calif) relative to the diameter of the aortic annulus on the rate and severity of aortic regurgitation in 28 consecutive patients initially considered eligible for transcatheter aortic valve implantation on the basis of angiography, multislice computed tomography, and transthoracic echocardiography. This policy included the systematic use of transesophageal echocardiography to exclude borderline patients and the modification of the procedure to use the larger device possible. The results were studied on an individual patient basis., Results: Because 6 of 28 patients (21%) had an annulus diameter greater than 24 mm by transesophageal echocardiography, 22 patients underwent implantation of the Edwards SAPIEN prosthesis. In 6 of 22 patients, the procedure was adapted to follow our "oversizing" policy. As a result, the "prosthesis/annulus cover index" was 12.4% ± 4.3%. The procedure was successful in 21 of 22 patients (95%), and 18 patients were available for echocardiography at 1 month. Although a moderate to severe aortic regurgitation was observed pretreatment in 4 of 18 patients (22%), it was no longer the case at 1 month (0/18, 0%; P = .03). The improvement was secondary to a disappearance of the aortic regurgitation in all 7 patients with a significant aortic regurgitation at pretreatment, whereas the new aortic regurgitations appearing in 5 of the 11 patients with no aortic regurgitation at pretreatment were only mild aortic regurgitations., Conclusions: In patients with a successful implantation of an Edwards SAPIEN valve, a simple "oversizing" policy based on a systematic use of transesophageal echocardiography and modification of the procedure may prevent the occurrence of moderate and severe aortic regurgitations., (Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Aims: To report our first-in-man experience with a new cerebral embolic deflection device (SMT Embolic Deflection Device) during transcatheter aortic valve implantation (TAVI). A significant number of strokes and brain infarcts are caused by embolisation of atherosclerotic material, clots and other debris during various phases of invasive cardiac procedures, especially TAVI. The application of a temporary filter in the aortic arch averting dislodged emboli from entering the cerebral circulation might prevent this., Methods and Results: In 15 patients (mean age 79 years) with severe aortic stenosis undergoing percutaneous transfemoral or transapical aortic valve implantation, the SMT Embolic Deflection Device was advanced utilising the contralateral femoral artery access using a 9 Fr delivery sheath. Once deployed in the aortic arch, a porous membrane shields the supraaortic-cerebral trunks by deflecting emboli away from the cerebral circulation. Embolic material is not contained or removed by the device. A 6 Fr pigtail catheter can be used through the same sheath throughout the whole procedure. Brain diffusion weighted (DW)-MRI was obtained in 10 patients before and at 4 days after (± 2 days) the procedure and retrospectively compared to 20 patients previously undergoing TAVI without a protection device. Successful placement of the embolic protection device was achieved in all patients. Additional procedural time due to the use of the device was 7 min (± 2 min). There were no procedural complications. No patient developed new neurological symptoms or clinical findings of stroke except one patient who suffered from a transient ischaemic attack (TIA) two days after the procedure. DW-MRI showed 3.2 new cerebral lesions per patient, compared to 7.2 new lesions per patient in the group without SMT filter., Conclusions: In this first-in-man experience, the feasibility of a new embolic deflection device is demonstrated. Larger randomised, prospective studies are required to confirm these findings and prove safety and efficacy by reducing the incidence of cerebral embolism and stroke after TAVI.