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114 results for “transcatheter aortic valve replacement”
Biological Collection and Registry of Patients Who Will Have a TAVR (Transcatheter Aortic Valve Replacement) Intervention
ClinicalTrials.gov study NCT02812953. IPD Sharing: UNDECIDED. Countries: 1. Publications: 0.
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement
ClinicalTrials.gov study NCT04944667. IPD Sharing: NO. Countries: 1. Publications: 0.
Dataset related to the article "Outcomes of Transcatheter Aortic Valve Replacement Patients With Different Transvalvular Flow-gradient Patterns"
<p>This record contains raw data related to the article "Outcomes of Transcatheter Aortic Valve Replacement Patients With Different Transvalvular Flow-gradient Patterns".</p><p>Low-flow low-gradient (LF-LG) aortic stenosis (AS) may occur with preserved or depressed left ventricular ejection fraction (LVEF). Both situations represent the most challenging subset of patients to manage and generally have a poor prognosis. Few and controversial data exist on the outcomes of these patients compared to normal-flow high-gradient (NF-HG) AS following transcatheter aortic valve replacement (TAVR). We sought to characterize different transvalvular flow-gradient patterns and to examine their prognostic value after TAVR. We enrolled 1208 patients with severe AS and categorized as follow: 976 patients NF-HG (mean aortic pressure gradient, MPG≥40mmHg), 107 paradoxical cLF-LG (pLF-LG, MPG<40mmHg, LVEF≥50%, stroke volume index, SVi<35mL/m2), and 125 cLF-LG (MPG<40mmHg, LVEF<50%, SVi<35mL/m2). When compared with NF-HG and pLF-LG, cLF-LG had a worse symptomatic status (NYHA III-IV 86% vs 62% and 67%, p<0.001), a higher prevalence of eccentric hypertrophy and a higher level of LV global afterload reflected by a higher valvuloarterial impedance. Valvular function after TAVR was excellent over time in all patients. While 30-day mortality (p=0.911) did not differ significantly among groups, cLF-LG had a lower 5-year survival rate (LF-LG 50% vs pLF-LG 62% and NF-HG 68%, p<0.05). cLF-LG was associated with a hazard ratio for mortality of 2.41 (95% CI: 1.65-3.52, p<0.001). In conclusion, TAVR is an effective procedure regardless of transvalvular flow-gradient patterns. However, special care should be given to characterized hemodynamic of AS, as patients with pLF-LG had similar survival rates than patients with NF-HG, whereas cLF-LG is associated with a 2-fold increased risk of mortality at 5-year follow-up.</p>
Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement
ClinicalTrials.gov study NCT07090811. IPD Sharing: Not stated. Countries: 0. Publications: 0.
Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement
ClinicalTrials.gov study NCT03600935. IPD Sharing: Not stated. Countries: 0. Publications: 0.
Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI) in Australia
ClinicalTrials.gov study NCT07121907. IPD Sharing: NO. Countries: 0. Publications: 0.
Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
ClinicalTrials.gov study NCT07100340. IPD Sharing: NO. Countries: 0. Publications: 0.
Brain Lesions After Transcatheter Aortic Valve Replacement
ClinicalTrials.gov study NCT05065697. IPD Sharing: Not stated. Countries: 0. Publications: 0.
Alternative Access Approaches for Transcatheter Aortic Valve Replace (TAVR) in Inoperable Patients With Aortic Stenosis
ClinicalTrials.gov study NCT01787084. IPD Sharing: Not stated. Countries: 0. Publications: 0.
Transcatheter Aortic Valve Replacement (TAVR)-Pilot Trial
ClinicalTrials.gov study NCT02723422. IPD Sharing: Not stated. Countries: 0. Publications: 0.
ROTAO 1 - Feasibility and Safety of the TAVIPILOT Tele-operated Robot During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
ClinicalTrials.gov study NCT07152574. IPD Sharing: Not stated. Countries: 0. Publications: 0.
Dataset related to article "Long term follow-up after balloon expandable covered stents implantation for management of transcatheter aortic valve replacement related vascular access complications"
<p>This record contains raw data related to article “Long term follow-up after balloon expandable covered stents implantation for management of transcatheter aortic valve replacement related vascular access complications"</p> <p>Abstract</p> <p><strong>Objectives: </strong> To report the experience of a high-volume center with balloon-expandable (BE) stents implantation to manage vascular complications after transcatheter aortic valve replacement (TAVR).</p> <p><strong>Background: </strong> Despite increased operator experience and better devices, vascular complications after TAVR are still a major issue and covered stent implantation is often required.</p> <p><strong>Methods: </strong> We retrospectively collected baseline and procedural data about 78 consecutive patients who underwent BE stent implantation to manage a vascular complication after transfemoral TAVR. Primary endpoints were technical success, incidence of new-onset claudication and need for vascular interventions during long-term follow-up. Secondary endpoints included length of hospitalization, in-hospital and 30-day mortality, and major postoperative complications.</p> <p><strong>Results: </strong> BE stents implantation to manage vascular complications after TAVR was successfully performed in 96.2% of the cases, with bailout surgery required in two cases. One patient suffered in-hospital death. Predischarge Doppler Ultrasound revealed no cases of in-stent occlusion or fracture. At a median follow-up of 429 days (interquartile range, 89-994 days), no cases of symptomatic leg ischemia were reported and only one patient experienced new-onset claudication.</p> <p><strong>Conclusions: </strong> Our experience showed good periprocedural and long-term results of BE covered stent implantation to manage vascular complication after TAVR. Their great radial outward force may guarantee effective hemostasis without necessarily being associated with stent deformation/fracture resulting in restenosis or further interventions. More research is needed to define the role of BE covered stents in this setting.</p>
Outcome of transcatheter aortic valve replacement in bicuspid aortic valve stenosis with new-generation devices.
<p>Dataset from Gorla R, Casenghi M, Finotello A, De Marco F, Morganti S, Regazzoli D, Bianchi G, Acerbi E, Popolo Rubbio A, Brambilla N, Testa L, Castriota F, Auricchio F, Reimers B, Bedogni F. Outcome of transcatheter aortic valve replacement in bicuspid aortic valve stenosis with new-generation devices. Interact Cardiovasc Thorac Surg. 2021 Jan 1;32(1):20-28. doi: 10.1093/icvts/ivaa231. PMID: 33201993.</p> <p>Abstract</p> <p><strong>Objectives: </strong>To compare device success and paravalvular leak rates of 3 new-generation transcatheter aortic valve replacement devices in patients with bicuspid aortic valve stenosis and to test their biomechanical performance in a computer-based simulation model of aortic root with increasing ellipticity.</p> <p><strong>Methods: </strong>This retrospective multicentre study included 56 bicuspid aortic valve patients undergoing transcatheter aortic valve replacement with new-generation devices: Lotus/Lotus Edge (N = 15; 27%), Evolut-R (N = 20; 36%) and ACURATE neo (N = 21; 37%). Three virtual simulation models of aortic root with increasing index of eccentricity (0-0.25-0.5) were implemented. Stress distribution, stent-root contact area and paravalvular orifice area were computed.</p> <p><strong>Results: </strong>Device success was achieved in 43/56 patients (77%) with comparable rates among Lotus (87%), Evolut-R (60%) and ACURATE neo (86%; P = 0.085). Moderate paravalvular leak rate was significantly lower in the Lotus group as compared to Evolut-R group (0% vs 30%; P = 0.027) and comparable to the ACURATE neo group (0% vs 10%; P = 0.33). By index of eccentricity = 0.5, Lotus showed a uniform and symmetric pattern of stress distribution with absent paravalvular orifice area, ACURATE neo showed a mild asymmetry with small paravalvular orifice area (1.1 mm2), whereas a severely asymmetric pattern was evident with Evolut-R, resulting in a large paravalvular orifice area (12.0 mm2).</p> <p><strong>Conclusions: </strong>Transcatheter aortic valve replacement in bicuspid aortic valve patients with new-generation devices showed comparable device success rates. Lotus showed moderate paravalvular leak rate comparable to that of ACURATE neo and significantly lower than Evolut-R. On simulation, Lotus and ACURATE neo showed optimal adaptability to elliptic anatomies as compared to Evolut-R.</p>
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>
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