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565 results for “transcatheter”
ExplorATory Study oF the EdWards Transcatheter Atrial Shunt System (AlT FloW Germany)
ClinicalTrials.gov study NCT04965623. IPD Sharing: Not stated. Countries: 0. Publications: 0.
Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation
ClinicalTrials.gov study NCT07321899. IPD Sharing: NO. Countries: 0. Publications: 0.
Retrospective Analysis of Procedural Aspects of Transcatheter Aortic Valve Implantation (TAVI) on Peri-procedural Stroke
ClinicalTrials.gov study NCT02711540. IPD Sharing: NO. Countries: 0. Publications: 0.
Transcatheter Arterial Embolization in Patients With Mild to Moderate Osteoarthritis
ClinicalTrials.gov study NCT05013970. IPD Sharing: NO. Countries: 0. Publications: 0.
Combined Mitral and Tricuspid Versus Isolated Mitral Transcatheter Edge-to-Edge Repair for Mitral Regurgitation With Tricuspid Regurgitation (DUAL-TEER Trial)
ClinicalTrials.gov study NCT07349888. IPD Sharing: Not stated. Countries: 0. Publications: 0.
VitaFlowTM II Transcatheter Aortic Valve System Study
ClinicalTrials.gov study NCT03575039. IPD Sharing: NO. Countries: 0. Publications: 0.
A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Safety of the Transcatheter Tricuspid Valvuloplasty System in Patients With Severe or Above Tricuspid Regurgitation
ClinicalTrials.gov study NCT05770648. IPD Sharing: Not stated. Countries: 0. Publications: 0.
Cardiac Troponin T After Transcatheter Closure of the Interatrial Septum
ClinicalTrials.gov study NCT03099967. IPD Sharing: NO. Countries: 0. Publications: 0.
TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique
ClinicalTrials.gov study NCT05577078. IPD Sharing: Not stated. Countries: 0. Publications: 0.
To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Insufficiency
ClinicalTrials.gov study NCT05424653. 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>
Dataset related to the article "Rest and exercise oxygen uptake and cardiac output changes 6 months after successful transcatheter mitral valve repair"
<p><strong>Aims: </strong>Changes in peak exercise oxygen uptake (VO<sub>2</sub> ) and cardiac output (CO) 6 months after successful percutaneous edge-to-edge mitral valve repair (pMVR) in severe primary (PMR) and functional mitral regurgitation (FMR) patients are unknown. The aim of the study was to assess the efficacy of pMVR at rest by echocardiography, VO<sub>2</sub> and CO (inert gas rebreathing) measurement and during cardiopulmonary exercise test with CO measurement.</p> <p><strong>Methods and results: </strong>We evaluated 145 and 115 patients at rest and 98 and 66 during exercise before and after pMVR, respectively. After successful pMVR, significant reductions in MR and NYHA class were observed in FMR and PMR patients. Cardiac ultrasound showed reverse remodelling (left ventricular end-diastolic volume from 158 ± 63 mL to 147 ± 64, P < 0.001; ejection fraction from 51 ± 15 to 48 ± 14, P < 0.001; pulmonary artery systolic pressure (PASP) from 43 ± 13 to 38 ± 8 mmHg, P < 0.001) in the entire population. These changes were significant in PMR (n = 62) and a trend in FMR (n = 53), except for PASP, which decreased in both groups. At rest, CO and stroke volume (SV) increased in FMR with a concomitant reduction in arteriovenous O<sub>2</sub> content difference [ΔC(a-v)O<sub>2</sub> ]. Peak exercise, CO and SV increased significantly in both groups (CO from 5.5 ± 1.4 L/min to 6.3 ± 1.5 and from 6.2 ± 2.4 to 6.7 ± 2.0, SV from 57 ± 19 mL to 66 ± 20 and from 62 ± 20 to 69 ± 20, in FMR and PMR, respectively), whereas peak VO<sub>2</sub> was unchanged and ΔC(a-v)O<sub>2</sub> decreased.</p> <p><strong>Conclusions: </strong>These data confirm pMVR-induced clinical improvement and reverse ventricular remodelling at a 6-month analysis and show, in spite of an increase in CO, an unchanged exercise performance, which is achieved through a 'more physiological' blood flow distribution and O<sub>2</sub> extraction behaviour. Direct rest and exercise CO should be measured to assess pMVR efficacy.</p> <p><strong>Keywords: </strong>Cardiac output; Exercise; Oxygen uptake; Percutaneous edge-to-edge mitral valve repair; Transcatheter mitral valve repair.</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>
Computer-based prediction of coronary artery compression in the planning of transcatheter pulmonary valve implantation.
<p>Datset from Pluchinotta FR, Caimi A, Pilati M, Carminati M, Sturla F. Computer-based prediction of coronary artery compression in the planning of transcatheter pulmonary valve implantation. EuroIntervention. 2021 Sep 20;17(7):584-585. doi: 10.4244/EIJ-D-20-01114. PMID: 33433388.</p> <p> </p>
Late Surgical Treatment for Transcatheter Aortic Valve Prosthesis Dysfunction
<p>Dataset from Malvindi PG, Lorusso R, Jiritano F, Santarpino G, Pilato M, Cammardella AG, van Putte B, Bonaros N, Garatti A, Paparella D. Late Surgical Treatment for Transcatheter Aortic Valve Prosthesis Dysfunction. Ann Thorac Surg. 2021 Apr;111(4):e271-e273. doi: 10.1016/j.athoracsur.2020.06.138. Epub 2020 Sep 24. PMID: 32979373.</p> <p>Abstract</p> <p>Structural valve degeneration, valve thrombosis, or acute infective endocarditis may affect the postprocedural outcome of transcatheter aortic valve implanted (TAVI) prostheses. Data of patients who required late surgical explant of TAVI prostheses were obtained from 8 European centers. There were 13 patients who underwent surgical treatment for TAVI prosthesis failure after original admission due to prosthetic infective endocarditis in 6 patients, structural valve degeneration in 4, and valve thrombosis in 3. Hospital mortality was 15%, and survival at the 2-year follow-up was 71%. Abstract word count: 80.</p>
Mitral Valve Surgery After Transcatheter Edge-to-Edge Repair: Mid-Term Outcomes From the CUTTING-EDGE International Registry
<p>Dataset from Kaneko T, Hirji S, Zaid S, Lange R, Kempfert J, Conradi L, Hagl C, Borger MA, Taramasso M, Nguyen TC, Ailawadi G, Shah AS, Smith RL, Anselmi A, Romano MA, Ben Ali W, Ramlawi B, Grubb KJ, Robinson NB, Pirelli L, Chu MWA, Andreas M, Obadia JF, Gennari M, Garatti A, Tchetche D, Nazif TM, Bapat VN, Modine T, Denti P, Tang GHL; CUTTING-EDGE Investigators. Mitral Valve Surgery After Transcatheter Edge-to-Edge Repair: Mid-Term Outcomes From the CUTTING-EDGE International Registry. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2010-2021. doi: 10.1016/j.jcin.2021.07.029. PMID: 34556275.</p> <p>Abstract</p> <p><strong>Objectives: </strong>The aim of this study was to determine clinical and echocardiographic characteristics, mechanisms of failure, and outcomes of mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER).</p> <p><strong>Background: </strong>Although >100,000 mitral TEER procedures have been performed worldwide, longitudinal data on MV surgery after TEER are lacking.</p> <p><strong>Methods: </strong>Data from the multicenter, international CUTTING-EDGE registry were retrospectively analyzed. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 9.0 months (interquartile range [IQR]: 1.2-25.7 months) after MV surgery, and follow-up was 96.1% complete at 30 days and 81.1% complete at 1 year.</p> <p><strong>Results: </strong>From July 2009 to July 2020, 332 patients across 34 centers underwent MV surgery after TEER. The mean age was 73.8 ± 10.1 years, median Society of Thoracic Surgeons risk for MV repair at initial TEER was 4.0 (IQR: 2.3-7.3), and primary/mixed and secondary mitral regurgitation were present in 59.0% and 38.5%, respectively. The median interval from TEER to surgery was 3.5 months (IQR: 0.5-11.9 months), with overall median Society of Thoracic Surgeons risk of 4.8% for MV replacement (IQR: 2.8%-8.4%). The primary indication for surgery was recurrent mitral regurgitation (33.5%), and MV replacement and concomitant tricuspid surgery were performed in 92.5% and 42.2% of patients, respectively. The 30-day and 1-year mortality rates were 16.6% and 31.3%, respectively. On Kaplan-Meier analysis, the actuarial estimates of mortality were 24.1% at 1 year and 31.7% at 3 years after MV surgery.</p> <p><strong>Conclusions: </strong>In this first report of the CUTTING-EDGE registry, the mortality and morbidity risks of MV surgery after TEER were not negligible, and only <10% of patients underwent MV repair. These registry data provide valuable insights for further research to improve these outcomes.</p>
Dataset related to the article "Leadless pacemaker implant, anticoagulation status, and outcomes: Results from the Micra Transcatheter Pacing System Post-Approval Registry"
<p>This record contains raw data related to the article "Leadless pacemaker implant, anticoagulation status, and outcomes: Results from the Micra Transcatheter Pacing System Post-Approval Registry". </p> <p> </p> <p><strong>Abstract</strong></p> <p><strong>Background: </strong>Early results from the Micra investigational trial and Micra Post-Approval Registry (PAR) demonstrated excellent safety and device performance; however, outcomes based on anticoagulation (AC) status at implant have not been evaluated.</p> <p><strong>Objective: </strong>The purpose of this study was to report implant characteristics, perforation rate, and vascular-related events based on perioperative oral AC strategy in patients undergoing Micra implant.</p> <p><strong>Methods: </strong>We compared procedure characteristics, major complications, and vascular events, including pericardial effusion, stratified by any adverse event (including major complications, minor complications, and observations) or major complication only according to AC status in the Micra PAR.</p> <p><strong>Results: </strong>Among 1795 patients with AC status available, 585 were not on AC, 795 had AC interrupted, and 415 had AC continued during Micra implant. Non-AC patients tended to be younger, with less history of atrial fibrillation and chronic obstructive pulmonary disease, and more history of dialysis than interrupted and continued patients. The implant success rate was similar for all groups (99.1%-99.8%). Through 30 days postimplant, the overall major complication rate was 3.1% for the non-AC group, 2.6% for the interrupted group, and 1.5% for the continued group. The combined rate for any vascular or pericardial effusion adverse event did not differ significantly among AC strategies (6.5%, 4.8%, and 3.6%, respectively).</p> <p><strong>Conclusion: </strong>Implant of Micra seems to be safe and feasible regardless of an interrupted or continued periprocedural oral AC strategy, with no increased risk of perforation or vascular complications.</p> <p><strong>Trial registration: </strong>ClinicalTrials.gov <a href="http://clinicaltrials.gov/show/NCT02536118">NCT02536118</a>.</p>
Dataset related to the article "Computed tomography predictors of structural valve degeneration in patients undergoing transcatheter aortic valve implantation with balloon-expandable prostheses"
<p>This record contains raw data related to the article "Computed tomography predictors of structural valve degeneration in patients undergoing transcatheter aortic valve implantation with balloon-expandable prostheses"</p> <p><strong>Objectives: </strong>Computed tomography (CT) provides excellent anatomy assessment of the aortic annulus (AoA) and is utilized for pre-procedural planning of transcatheter aortic valve implantation (TAVI). We sought to investigate if geometrical characteristics of the AoA determined by CT may represent predictors of structural valve degeneration (SVD) in patients undergoing TAVI with balloon-expandable valves.</p> <p><strong>Methods: </strong>Retrospective study on 124 consecutive patients (mean age:79±7 years; female: 61%) undergoing balloon-expandable TAVI prospectively enrolled in a registry<strong>. </strong>AoA maximum diameter (D<sub>max</sub>), minimum diameter (D<sub>min</sub>), and area were assessed using pre-procedural CT. SVD was identified during follow-up with transthoracic echocardiography documenting structural prosthetic valve abnormalities with or without hemodynamic changes. </p> <p><strong>Results: </strong>The mean follow up was 5.9±1.7 years. SVD was found in 48 out of 124 patients (38%). AoA D<sub>max</sub>, D<sub>min</sub> and area were significantly smaller in patients with SVD compared to patients without SVD (25.6±2.2 mm vs. 27.1±2.8 mm , p=0.012; 20.5±2.1 mm vs. 21.8±2.1 mm ,p=0.001 and 419±77 mm<sup>2 </sup>vs. 467±88 mm<sup>2</sup>,p=0.002, respectively). At univariable analysis, female sex, BSA, 23-mm prosthetic valve size, D<sub>max</sub> <27.1 mm and a D<sub>min</sub> < 19.9 mm were associated with SVD whereas at multivariable analysis, only D<sub>min</sub> <19.9 mm (OR=2.873, 95% CI: 1.191-6.929,p=0.019) and female sex (OR=2.659, 95% CI: 1.095-6.458, p=0.031) were independent predictors of SVD.</p> <p><strong>Conclusions: </strong>Female sex and AoA D<sub>min</sub> < 19.9 mm are associated with SVD in patients undergoing TAVI with balloon expandable valves. When implanting large prostheses in order to avoid paraprosthetic regurgitation, caution should be observed due to the risk of excessive stretching of the AoA D<sub>min,</sub> which may play a role in SVD.</p>
DataSet_Simultaneous versus staged approach in transcatheter aortic valve implantation for severe stenosis and endovascular aortic repair for thoracic and abdominal aortic aneurysm
Open the record for dataset details and reuse information.
Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System
<p>Dataset from Fontana GP, Bedogni F, Groh M, Smith D, Chehab BM, Garrett HE Jr, Yong G, Worthley S, Manoharan G, Walton A, Hermiller J, Dhar G, Waksman R, Ramana RK, Mahoney P, Asch FM, Chakravarty T, Jilaihawi H, Makkar RR. Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System. JACC Cardiovasc Interv. 2020 Nov 9;13(21):2467-2478. doi: 10.1016/j.jcin.2020.06.041. Epub 2020 Jul 20. PMID: 33153563.</p> <p><strong>Abstract</strong></p> <p><strong>Objectives: </strong>The aim of this study was to characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile delivery system (DS).</p> <p><strong>Background: </strong>Key design modifications to the FlexNav DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in vessels with diameter ≥5 mm.</p> <p><strong>Methods: </strong>Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.S. IDE Trial] [n = 134] and the FlexNav EU CE Mark Study [n = 46]) for the analysis. The primary endpoint was Valve Academic Research Consortium-2-defined major vascular complications at 30 days. Clinical outcomes and valve performance were assessed through 30 days by an independent clinical events committee and an echocardiography core laboratory, respectively.</p> <p><strong>Results: </strong>One hundred forty high-risk and 40 extreme-risk subjects enrolled between October 15, 2018, and December 10, 2019, from 28 sites in the United States, Australia, and Europe who underwent attempted transfemoral Portico valve implantation were included. The mean age was 85.1 ± 5.6 years, 60% were women, the mean Society of Thoracic Surgeons score was 5.3%, and 96.1% presented with ≥1 frailty factor. Technical device success was 96.7%. At 30 days, the rate of major vascular complications was 5.0%, with 4.4% of complications adjudicated as access site-related (3.3% transcatheter aortic valve replacement DS access site-related). Death (0.6%) and disabling stroke (1.1%) were rare. The rate of new permanent pacemaker implantation was 15.4%. Echocardiography revealed a mean gradient of 7.1 ± 3.2 mm Hg, mean valve area of 1.77 ± 0.41 cm<sup>2</sup>, and a 4.1% rate of moderate paravalvular leak at 30 days.</p> <p><strong>Conclusions: </strong>Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days.</p> <p> </p>
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