39 research outputs found

    Стан та перспективи конкурентоспроможності галузі національного господарства в умовах глобалізації

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    Метою дослідження є узагальнення нових теоретичних положень розвитку галузей економіки в умовах глобалізації, визначення загальних конкурентних переваг хімічної галузі України та практичних напрямів сучасного розвитку економіки країни

    Transcatheter aortic valve implantation in patients younger than 75\u202fyears: Guidelines-based patients selection and clinical outcome

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    Background: Patients treated by transcatheter aortic valve implantation (TAVI) in all major recent trials are still mostly octogenarians. Aim of this study is to analyze the risk profile and outcome of TAVI patients <75 years. Methods and results: We retrospectively analyzed 172 patients <75 years with symptomatic severe native AS or degeneration of surgical aortic bioprosthesis treated with TAVI. The level of surgical risk was reassessed according to multiparametric ACC classification (prohibitive in 68 patients, high in 34, intermediate in 70). Mean age was 69.02 ± 6.18 years, mean STS score 5.56 ± 5.21. The majority of them presented one or more clinical or anatomical characteristics favoring TAVI according to ECS guidelines, despite the young age. Vascular access was transfemoral in 76%. According to the VARC-2 definitions, device success was high (90%) in all groups. The early safety was 89%, clinical recovery was slower in prohibitive risk patients. Bleeding events were more frequent in prohibitive and high surgical risk classes. Clinical efficacy at 1 year was overall 83%, and significantly better in intermediate risk patients (p = 0.004). The functional status remained stable over time as well as prostheses performance. Conclusion: About 40% of patients <75 years were treated by TAVI due to the presence of a prohibitive risk, mainly related to technical impediments. The remaining was referred to TAVI due to an estimated high or intermediate surgical risk driven by STS score, frailty and/or major organ system compromise. Early and mid-term clinical and hemodynamic outcomes were good, in particular in intermediate risk patients

    Transcatheter aortic valve implantation with the Portico and Evolut R bioprostheses in patients with elliptic aortic annulus

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    AIMS: To compare paravalvular leak (PVL) and device success rate of two self-expanding devices (Portico and Evolut-R) in patients with elliptic aortic annulus undergoing transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: This retrospective study included 374 patients submitted to TAVI with Portico (n=111) and Evolut-R (n=263), and available aortic annulus measurements at computed tomography angiography. Aortic annulus was defined elliptic if the index of eccentricity (IE=1-aortic annulus (minimum diameter)/(maximum diameter)) was >0.25. Device behavior to annulus eccentricity variations was measured by computational simulation in an idealized aortic root with three different IE (0, 0.25, and 0.5). An elliptic aortic annulus was found in 107 (28.6%) of 374 patients. Fewer rates of >moderate PVL were observed in Portico elliptic group compared to Evolut-R elliptic group (0.0% vs.15.2%; P=0.034). Device success in Portico elliptic group (100%) was significantly higher compared to that of Evolut-R elliptic group (84.8%; P=0.019). Eccentricity was a positive predictor of device success only in Portico patients (P=0.021). On computational simulation, Portico showed stable stent root interaction area, stress distribution, and regurgitant orifice area for IE=0.25 and 0.5. CONCLUSIONS: Portico showed good adaptability to annulus eccentricity variations and excellent PVL/device success rates in elliptic patients, compared to Evolut-R

    Impact of periprocedural stroke on mid-term mortality after transcatheter aortic valve implantation

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    Purpose: Stroke occurrence in patients undergoing transcatheter aortic valve implantation (TAVI) has been reported among complications in several studies. The aim of this study was to assess the impact of periprocedural stroke on mortality at mid-term follow-up after TAVI. Methods: Six-hundred-fifty-six patients with aortic stenosis underwent TAVI with the CoreValve system (92.8%) or the Edwards SAPIEN valve system (7.2%). Stroke and transient ischemic attack were defined according to the Valve Academic Research Consortium-2 consensus document. A cerebrovascular accident (CVA) was defined as any stroke or transient ischemic attack. Periprocedural stroke or CVA were defined as stroke or CVA occurring within 72 hours from the index procedure. Separate multivariable Cox regression analyses were performed to calculate hazard ratio (HR) with 95% confidence intervals (CI) of mortality for periprocedural stroke and periprocedural CVA, respectively. Results: Procedural success occurred in 97.4% of patients. The incidence of any stroke and of CVA after the index procedure was 2.4% and 2.7%, respectively. Periprocedural strokes accounted for 56.2% of all strokes and occurred in 1.4% of patients included in the study. Periprocedural CVA accounted for 55.6% of all CVA and occurred in 1.5% of patients. After a median follow-up of 434 days, all-cause mortality was significantly higher in patients with periprocedural stroke as compared to those without (66.7% vs 22.9%, logrank p=0.001), and in patients with periprocedural CVA as compared to those without (70.0% vs 22.8%, logrank p<0.001). At multivariable Cox regression, periprocedural stroke (HR 4.66, 95% CI 1.95-11.1, p=0.001) and periprocedural CVA (HR 4.64, 95% CI 2.06-10.5, p<0.001) were significant predictors of all-cause mortality. Conclusions: More than half of strokes and CVA following TAVI occur within the periprocedural period. Periprocedural stroke and CVA are independent predictors of all-cause mortality at mid-term follow-up. Strategies for periprocedural cerebrovascular events prevention are needed

    Procedural and 30-day clinical outcomes following transcatheter aortic valve replacement with lotus valve: Results of the RELEVANT study

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    OBJECTIVES: We report procedural and 30-day clinical outcomes following transcatheter aortic valve replacement (TAVR) with Lotus Valve system in a high-risk population. BACKGROUND: Lotus valve is a second-generation TAVR fully repositionable and retrievable device. RELEVANT (REgistry of Lotus valvE for treatment of aortic VAlve steNosis with Tavr) study is an Italian prospective multicentre registry. METHODS: Five major centers performing TAVR using Lotus participated. All high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVR. Primary end-points were procedural and 30-day mortality. Secondary endpoints included procedural and 30-day safety/effectiveness metrics according to Valve Academic Research Consortium (VARC)-2 criteria. RESULTS: Two hundred and twenty-five patients undergoing TAVR with Lotus were enrolled. Mean age was 82.6\u2009\ub1\u20096.3 years, 51.6% females. Mean STS score for mortality was 8.3\u2009\ub1\u20095.6. Procedural success was achieved in 98.7% of patients. All-cause mortality was 2.2% at discharge and 2.7% at 30-day. Stroke rate was 2.2% at discharge and 3.1% at 30-day. Patients requiring a new permanent pacemaker implantation were 30.7% at discharge and 31.8% at 30-day. Paravalvular regurgitation (PVR) was trace/mild in 99.1% of patients at discharge. Only two patients (0.9%) had moderate PVR at discharge and at 30-day, whereas none had severe PVR. CONCLUSIONS: RELEVANT study showed that TAVR using Lotus, in a real-world population of patients with severe aortic stenosis at high surgical risk, was associated with excellent device success implantation and early safety according to VARC-2 definition. The pacemaker implantation rate was about a third of patients. \ua9 2017 Wiley Periodicals, Inc

    Five-year clinical outcomes after percutaneous edge-to-edge mitral valve repair: Insights from the multicenter GRASP-IT registry

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    Background Limited evidence is available on 5-year clinical outcomes after percutaneous edge-to-edge mitral valve repair.Methods The Getting Reduction of mitrAl inSufficiency by Percutaneous clip implantation in Frilly (GRASP-IT) is a multicenter registry including 304 consecutive patients undergoing Mitraclip between October 2008 and October 2013 at 4 Italian centers. Primary end point (all-cause mortality) and secondary end point (all-cause mortality or heart failure [HF] hospitalization) were evaluated up to 5 years and between 1 and 5 years.Results Cumulative incidence of the primary and secondary end points at 1, 2, 3, 4, and 5 years were 15.1%, 26.4%, 35.5%, 42.1%, and 47.3% and 29.1%, 41.7%, 49.8%, 56%, and 62.3%, respectively. Landmark analysis between 1 and 5 years showed an incidence of primary and secondary end point of 37.9% and 46.8%, respectively. Five-year event rates were significantly higher in patients with functional ischemic mitral regurgitation (MR) compared to other etiologies. MR recurrence and left ventricular ejection fraction &lt;30% were associated with an increased risk of both primary and secondary end points. EuroSCORE II &gt;5% was associated with an increased risk of 5-year mortality. Ischemic etiology of MR, baseline serum creatinine &gt;1.5 mg/dl, chronic obstructive pulmonary disease, and previous HF hospitalizations were independent predictors of 5-year secondary end point.Conclusions At 5-year follow-up after Mitraclip, nearly half of patients died and almost two thirds died or were admitted for HF. MR recurrence, ischemic etiology, high comorbidity burden (ie, EuroSCORE II &gt;5%, chronic obstructive pulmonary disease), and advanced cardiomyopathy (ie, left ventricular ejection fraction &lt;30%, prior HF admission, creatinine &gt;1.5 mg/dl) significantly increase the relative risk of 5-year clinical events

    2-year results of CoreValve implantation through the subclavian access: A propensity-matched comparison with the femoral access

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    ObjectivesThe goal of this study was to assess the procedural and 2-year results of the subclavian approach for transcatheter aortic valve implantation (TAVI) compared with those of the femoral approach by using propensity-matched analysis.BackgroundThe subclavian approach with the CoreValve prosthesis (Medtronic, Inc., Minneapolis, Minnesota) represents an interesting opportunity when the femoral access is unfeasible.MethodsAll consecutive patients enrolled in the Italian CoreValve Registry who underwent TAVI with the subclavian approach were included. Propensity score analysis was used to identify a matching group of patients undergoing femoral TAVI.ResultsSubclavian approach was used in 141 patients (61% men; median age 83 years; median logistic European System for Cardiac Operative Risk Evaluation score 23.7%). The femoral group of 141 patients was matched for baseline clinical characteristics, except for peripheral artery disease. The 2 groups showed similar procedural success (97.9% vs. 96.5%; p = 0.47), major vascular complications (5.0% vs. 7.8%; p = 0.33), life-threatening bleeding events (7.8% vs. 5.7%; p = 0.48), and combined safety endpoint (19.9% vs. 25.5%; p = 0.26). The subclavian group showed lower rates of acute kidney injury/stage 3 (4.3% vs. 9.9%; p = 0.02), of minor vascular complications at the 18-F sheath insertion site (2.1% vs. 11.3%; p = 0.003), and of all types of bleeding events related to vascular complications. Survival at 2 years was 74.0 ± 4.0% in the subclavian group compared with 73.7 ± 3.9% in the femoral group (p = 0.78). The 2-year freedom from cardiovascular death was 87.2 ± 3.1% versus 88.7 ± 2.8% in the subclavian versus femoral group, respectively (p = 0.84).ConclusionsThe subclavian approach for TAVI is safe and feasible, with procedural and medium-term results similar to the femoral approach. Subclavian access should be considered a valid option not only when the femoral approach is impossible but also when it is difficult, albeit feasible
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