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- Wykrzykowska, Joanna J, et al.
(författare)
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Bioresorbable Scaffolds versus Metallic Stents in Routine PCI.
- 2017
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Ingår i: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 376:24, s. 2319-2328
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Bioresorbable vascular scaffolds were developed to overcome the shortcomings of drug-eluting stents in percutaneous coronary intervention (PCI). We performed an investigator-initiated, randomized trial to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in the context of routine clinical practice.METHODS: We randomly assigned 1845 patients undergoing PCI to receive either a bioresorbable vascular scaffold (924 patients) or a metallic stent (921 patients). The primary end point was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization). The data and safety monitoring board recommended early reporting of the study results because of safety concerns. This report provides descriptive information on end-point events.RESULTS: The median follow-up was 707 days. Target-vessel failure occurred in 105 patients in the scaffold group and in 94 patients in the stent group (2-year cumulative event rates, 11.7% and 10.7%, respectively; hazard ratio, 1.12; 95% confidence interval [CI], 0.85 to 1.48; P=0.43); event rates were based on Kaplan-Meier estimates in time-to-event analyses. Cardiac death occurred in 18 patients in the scaffold group and in 23 patients in the stent group (2-year cumulative event rates, 2.0% and 2.7%, respectively), target-vessel myocardial infarction occurred in 48 patients in the scaffold group and in 30 patients in the stent group (2-year cumulative event rates, 5.5% and 3.2%), and target-vessel revascularization occurred in 76 patients in the scaffold group and in 65 patients in the stent group (2-year cumulative event rates, 8.7% and 7.5%). Definite or probable device thrombosis occurred in 31 patients in the scaffold group as compared with 8 patients in the stent group (2-year cumulative event rates, 3.5% vs. 0.9%; hazard ratio, 3.87; 95% CI, 1.78 to 8.42; P<0.001).CONCLUSIONS: In this preliminary report of a trial involving patients undergoing PCI, there was no significant difference in the rate of target-vessel failure between the patients who received a bioresorbable scaffold and the patients who received a metallic stent. The bioresorbable scaffold was associated with a higher incidence of device thrombosis than the metallic stent through 2 years of follow-up. (Funded by Abbott Vascular; AIDA ClinicalTrials.gov number, NCT01858077 .).
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| 2. |
- Rosseel, Liesbeth, et al.
(författare)
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Contemporary European practice in transcatheter aortic valve implantation: results from the 2022 European TAVI Pathway Registry.
- 2023
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Ingår i: Frontiers in cardiovascular medicine. - 2297-055X. ; 10
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Tidskriftsartikel (refereegranskat)abstract
- A steep rise in the use of transcatheter aortic valve implantation (TAVI) for the management of symptomatic severe aortic stenosis occurred. Minimalist TAVI procedures and streamlined patient pathways within experienced Heart Valve Centres are designed to overcome the challenges of ever-increasing procedural volume.The 2022 European TAVI Pathway Survey aims to describe contemporary TAVI practice across Europe.Between October and December 2022, TAVI operators from 32 European countries were invited to complete an online questionnaire regarding their current practice.Responses were available from 147 TAVI centres in 26 countries. In 2021, the participating centres performed a total number of 27,223 TAVI procedures, with a mean of 185 TAVI cases per centre (median 138; IQR 77-194). Treatment strategies are usually (87%) discussed at a dedicated Heart Team meeting. Transfemoral TAVI is performed with local anaesthesia only (33%), with associated conscious sedation (60%), or under general anaesthesia (7%). Primary vascular access is percutaneous transfemoral (99%) with secondary radial access (52%). After uncomplicated TAVI, patients are transferred to a high-, medium-, or low-care unit in 28%, 52%, and 20% of cases, respectively. Time to discharge is day 1 (12%), day 2 (31%), day 3 (29%), or day 4 or more (28%).Reported adoption of minimalist TAVI techniques is common among European TAVI centres, but rates of next-day discharge remain low. This survey highlights the significant progress made in refining TAVI treatment and pathways in recent years and identifies possible areas for further improvement.
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| 5. |
- Elkoumy, Ahmed, et al.
(författare)
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ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty : direct ACURATE neo2
- 2024
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Ingår i: International Journal of Cardiology. - 0167-5273 .- 1874-1754. ; 400
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Tidskriftsartikel (refereegranskat)abstract
- Background: ACURATE neo2 (Neo2) implantation is performed after systematic Balloon Aortic Valvuloplasty (BAV) in most patients. No reports exist about the feasibility and safety of direct Neo2 transcatheter aortic valve implantation (TAVI) in comparison to the standard practice. Aim: We aimed to identify the patients' baseline anatomical characteristics, procedural, and early post-procedural outcomes in patients treated using Neo2 with and without BAV. Methodology: This is a retrospective multicentre analysis of 499 patients with severe aortic stenosis who underwent TAVI using Neo2. The comparison was done according to the performance or omission of BAV. Echocardiography and computed tomography were analysed by an independent Core Lab. Propensity score matching (PSM) was performed based on the annular diameter and AV calcium volume, which identified 84 matched pairs. Results: Among the cohort included, 391 (78%) patients received BAV (BAV-yes) and 108 (22%) were not attempted (BAV-no or Direct TAVI). Patients in BAV-no cohort had smaller annular diameter (22.6 vs 23.4 mm; p < 0.001) and lower calcium volume (163 vs 581 mm3; p < 0.001) compared to BAV-yes cohort. In the matched cohort, VARC-3 device technical success was similar (95%) and all other outcome measures were statistically comparable between cohorts. Conclusion: Direct TAVI using ACURATEneo2 without pre-TAVI balloon aortic valvuloplasty in patients with mild or less valve calcifications might be feasible and associated with comparable early outcomes compared to patients with similar anatomical features undergoing systematic balloon valvuloplasty.
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| 6. |
- Rück, Andreas, et al.
(författare)
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The Early neo2 Registry : Transcatheter Aortic Valve Implantation With ACURATE neo2 in a European Population
- 2023
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Ingår i: Journal of the American Heart Association. - 2047-9980. ; 12:15
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: ACURATE neo2 is a transcatheter aortic valve implantation system consisting of a self-expanding bioprosthetic valve with supra-annular leaflet position and featuring innovations to facilitate placement accuracy and reduce paravalvular regurgitation. METHODS AND RESULTS: The goal of the Early neo2 (Early neo2 Registry of the ACURATE neo2 TAVI Prosthesis) was to gather real-life data on safety and efficacy in a European transcatheter aortic valve implantation population treated with ACURATE neo2. Data were collected from 554 consecutive patients treated with ACURATE neo2 at 12 European sites (mean age, 82 years; 66% women; mean European System for Cardiac Operative Risk Evaluation II, 4.5%±3.8%) between September 2020 and March 2021. The composite primary end point was the occurrence of any of the following: postoperative (in-hospital) paravalvular regurgitation grade ≥2, in-hospital acute kidney injury stage 3, postoperative pacemaker implantation, 30-day death, and 30-day stroke. The primary end point occurred in 12.6% of patients. The 30-day rates for all-cause death and all stroke were 1.3% and 2.7%, respectively, and 1.5% of patients exhibited stage 3 acute kidney injury. A total of 34 patients (6.2%) received a postoperative permanent pacemaker. Per core laboratory–adjudicated echocardiographic analysis, mean postoperative aortic valve gradient was 7.6±3.3 mm Hg, and 2.8% of patients exhibited paravalvular regurgitation grade ≥2. CONCLUSIONS: In this report of postmarket use of the ACURATE neo2 valve in a real-world transcatheter aortic valve implantation population, patients exhibited favorable postoperative hemodynamics and clinical outcomes and a low rate of postoperative pacemaker implantation.
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| 7. |
- Sarno, Giovanna, et al.
(författare)
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Intravascular ultrasound radiofrequency analysis after optimal coronary stenting with initial quantitative coronary angiography guidance : an ATHEROREMO sub-study
- 2011
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Ingår i: EuroIntervention. - 1774-024X .- 1969-6213. ; 6:8, s. 977-984
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Tidskriftsartikel (refereegranskat)abstract
- AIMS:To investigate whether the use of intravascular ultrasound virtual histology (IVUS-VH) leads to any improvements in stent deployment, when performed in patients considered to have had an optimal percutaneous coronary intervention (PCI) by quantitative coronary angiography (QCA).METHODS AND RESULTS:After optimal PCI result (residual stenosis by QCA<30%), IVUS-VH was performed in 100 patients by protocol, with the option to use the information left to the discretion of the operators. Patients were categorised as: Group1 (n=54), where the IVUS-VH findings were used to evaluate the need for further optimisation of the stent deployment; and Group2 (n=46), where the IVUS-VH was documentary such that the stenting results were considered optimal according to QCA. Optimal stent deployment on IVUS-VH was defined as: normal stent expansion, absence of stent malapposition, complete lesion coverage as indicated by a plaque burden (PB%) between 30-40% and necrotic core confluent to the lumen<10% or PB%<30% at the 5 mm proximal and distal to the stent. The first IVUS-VH in all patients demonstrated the achievement of optimal stent deployment, incomplete lesion coverage, stent under-expansion and stent-edge dissection in 60%, 31%, 20% and 8% of patients, respectively. There was no stent malapposition. In Group 1, 25 patients had optimal stent deployment and did not require further intervention, whilst in 29 patients further intervention was needed (additional stent, n=18; post-dilatation, n=29). Overall optimal stent deployment was finally achieved in 52/54 patients (96%) in Group 1 and 35/46 (76%) of Group 2, p<0.05.CONCLUSIONS:IVUS-VH may have a role in facilitating optimal stent implantation and complete lesion coverage.
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