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565 results for “transcatheter”
First-in-Man Study Evaluating the Emblok Embolic Protection System During Transcatheter Aortic Valve Replacement
<p>Dataset from the article Latib A, Mangieri A, Vezzulli P, Spagnolo P, Sardanelli F, Fellegara G, Pagnesi M, Giannini F, Falini A, Gorla R, Montorfano M, Bedogni F, Colombo A, Popma J, Merhi WM, De Marco F. First-in-Man Study Evaluating the Emblok Embolic Protection System During Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2020 Apr 13;13(7):860-868. doi: 10.1016/j.jcin.2019.11.017. PMID: 32273098.</p> <p><strong>Abstract</strong></p> <p><strong>Objectives: </strong>This study sought to evaluate the feasibility of complete cerebral protection during transcatheter aortic valve replacement (TAVR) with a novel embolic protection device.</p> <p><strong>Background: </strong>Evidences and data about new cerebral embolic protection devices are lacking and scarce.</p> <p><strong>Methods: </strong>A prospective, nonrandomized, multicenter, first-in-man pilot study designed to evaluate the efficacy and safety of cerebral embolic protection utilizing the Emblok embolic protection system (Innovative Cardiovascular Solutions, Grand Rapids, Michigan) during TAVR. The Emblok is a transfemoral aortic filter that provide full coverage of the epiaortic vessels. Brain diffusion-weighted magnetic resonance imaging (DW-MRI) was performed at baseline and 2 to 5 days after TAVR. Primary endpoints were technical success and immediate cerebral embolic burden after TAVR, defined as number and volume of new brain lesions detected with DW-MRI at days 2 to 5 post-TAVR compared with baseline.</p> <p><strong>Results: </strong>A total of 20 subjects were enrolled. The Emblok system was successfully positioned in all the cases. At 30-day follow-up, no major adverse cardiovascular and cerebrovascular events occurred. Nineteen (95%) patients had new ischemic defects at post-procedural DW-MRI. The median number of new lesions per patient was 10.00 (interquartile range [IQR]: 4.75 to 15.25). The total new lesion volume was 199.9 mm<sup>3</sup> (IQR: 83.9 to 447.5 mm<sup>3</sup>) and the mean lesion volume per lesion was 42.5 mm<sup>3</sup> (IQR: 21.5 to 75.6 mm<sup>3</sup>). Histopathologic analysis showed evidence of significant debris in 18 (90%) filters.</p> <p><strong>Conclusions: </strong>The Emblok embolic protection system appears to be feasible and safe during TAVR. The device was successfully placed and retrieved in all cases and no neurological events were observed. Cerebral total new lesion volume was similar to other trials on cerebral protection during TAVR, thus warranting a larger study. (European Study Evaluating the Emblok Embolic Protection System During TAVR.</p>
Impact of aortic angle on transcatheter aortic valve implantation outcome with Evolut-R, Portico, and Acurate-NEO
<p>Dataset from Gorla R, De Marco F, Garatti A, Bianchi G, Popolo Rubbio A, Acerbi E, Casenghi M, Spagnolo P, Brambilla N, Testa L, Agnifili ML, Tusa M, Bedogni F. Impact of aortic angle on transcatheter aortic valve implantation outcome with Evolut-R, Portico, and Acurate-NEO. Catheter Cardiovasc Interv. 2021 Jan 1;97(1):E135-E145. doi: 10.1002/ccd.28957. Epub 2020 May 13. PMID: 32400068.</p> <p><strong>Abstract</strong></p> <p><strong>Objectives: </strong>To investigate paravalvular leak (PVL) and devices success rates according to aortic angle (AA) in patients undergoing transcatheter aortic valve implantation (TAVI) with three new-generation self-expanding devices.</p> <p><strong>Background: </strong>The impact of aortic angle (AA) on TAVI device success and PVL rates is controversial.</p> <p><strong>Methods: </strong>This retrospective study included 392 patients submitted to TAVI for severe aortic stenosis with Portico, Evolut-R and Acurate-NEO, and available AA measurements at computed tomography (CT) angiography. AA was calculated from the implantation projection and was defined as the angle between the plane of aortic annulus and an ideal horizontal plane. Aorta was defined horizontal if AA>57° (75th percentile).</p> <p><strong>Results: </strong>In the horizontal group, the rates of moderate/severe PVL was higher in the Evolut-R group (20.8%), which was also characterized by a lower implant compared to that of Acurate-NEO, whereas device success was comparable among the three devices. AA was a significant predictor of moderate/severe PVLs (AUC 0.72, p = .002) only in the Evolut-R population. On multivariate analysis, calcium volume 850HU, bicuspid aortic valve, and implantation depth at the level of left coronary cusp were independent predictors of moderate/severe PVL. On univariate analysis in the horizontal aorta population, implantation depth was confirmed among the most significant predictors of moderate/severe PVL.</p> <p><strong>Conclusions: </strong>Despite comparable device success rates, horizontal aorta represented a technical challenge only in the Evolut-R subgroup, which showed higher rates of moderate/severe PVL than Portico and Acurate-NEO, and was associated with a low implant.</p>
One-year safety and efficacy profile of transcatheter aortic valve-in-valve implantation with the portico system
<p>Dataset from Casenghi M, Gorla R, Popolo Rubbio A, De Marco F, Brambilla N, Agnifili M, Testa L, Bedogni F. One-year safety and efficacy profile of transcatheter aortic valve-in-valve implantation with the portico system. Catheter Cardiovasc Interv. 2021 Jul 1;98(1):E145-E152. doi: 10.1002/ccd.29353. Epub 2020 Nov 6. PMID: 33155757.</p> <p>Abstract</p> <p><strong>Objective: </strong>This study sought to investigate the procedural and mid-term outcomes of transcatheter aortic valve implantation for failed surgical bioprostheses (TAVI-ViV) with Portico device.</p> <p><strong>Background: </strong>Limited evidence coming from early experience on Portico system does not allow to fully assess safety and efficacy of this device in this ViV patients.</p> <p><strong>Methods: </strong>From January 2016 up to June 2019, 56 consecutive patients undergoing TAVI-ViV with Portico were prospectively included in our institutional TAVI database.</p> <p><strong>Results: </strong>The prevalent mechanism of failure was stenosis (58.9%); true internal diameter (ID) was <21 mm in 71.4% of cases. Device success rate were 69.6% with 14 (25%) patients showing a residual gradient ≥20 mmHg, 2 (3.6%) a PVL ≥ moderate and 1 (1.8%) required a second THV implantation due to device embolization. At 1-year follow-up 5 patients (8.9%) died whereas moderate SVD was reported in 2 (3.6%). Patients with a post-procedural mean gradient ≥20 mmHg showed a significantly higher rate of CV hospitalization (21.4% vs. 2.4%, p = .02) whereas no differences in procedural and 1-year outcomes were noticed according to true ID diameter or degeneration mode. Chimney stenting (ChT) was performed in 23 (41%) patients without significant differences in procedural and 1-year outcomes compared to non-ChT group.</p> <p><strong>Conclusions: </strong>TAVI-ViV with Portico valve was associated with good procedural and 1-year outcomes, even in patients with features of high procedural and anatomical complexity.</p>
Data set related to the article "Predictors of Prognosis in Patients With Secondary Mitral Regurgitation Undergoing Mitral Valve Transcatheter Edge-to-Edge Repair"
<p>This record contains raw data related to the article <em>Predictors of Prognosis in Patients With Secondary Mitral Regurgitation Undergoing Mitral Valve Transcatheter Edge-to-Edge Repair</em></p>
Data set from Gorla R, De Marco F, Morganti S, Finotello A, Brambilla N, Testa L, Agnifili ML, Tusa M, Auricchio F, Bedogni F. Transcatheter aortic valve implantation with the Portico and Evolut R bioprostheses in patients with elliptic aortic annulus. EuroIntervention. 2020 Apr 3;15(18):e1588-e1591. doi: 10.4244/EIJ-D-19-00115. PMID: 31186219.
<p>Data set from Gorla R, De Marco F, Morganti S, Finotello A, Brambilla N, Testa L, Agnifili ML, Tusa M, Auricchio F, Bedogni F. Transcatheter aortic valve implantation with the Portico and Evolut R bioprostheses in patients with elliptic aortic annulus. EuroIntervention. 2020 Apr 3;15(18):e1588-e1591. doi: 10.4244/EIJ-D-19-00115. PMID: 31186219.</p> <p> </p><p> </p> <p></p>
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