Angulation and curvature of aortic landing zone affect implantation depth in transcatheter aortic valve implantation

: In transcatheter aortic valve implantation (TAVI), final device position may be affected by device interaction with the whole aortic landing zone (LZ) extending to ascending aorta. We investigated the impact of aortic LZ curvature and angulation on TAVI implantation depth, comparing short-frame balloon-expanding (BE) and long-frame self-expanding (SE) devices. Patients (n = 202) treated with BE or SE devices were matched based on one-to-one propensity score. Primary endpoint was the mismatch between the intended (HPre) and the final (HPost) implantation depth. LZ curvature and angulation were calculated based on the aortic centerline trajectory available from pre-TAVI computed tomography. Total LZ curvature ( kLZ,tot ) and LZ angulation distal to aortic annulus ( αLZ,Distal ) were greater in the SE compared to the BE group (P < 0.001 for both). In the BE group, HPost was significantly higher than HPre at both cusps (P < 0.001). In the SE group, HPost was significantly deeper than HPre only at the left coronary cusp (P = 0.013). At multivariate analysis, αLZ,Distal was the only independent predictor (OR = 1.11, P = 0.002) of deeper final implantation depth with a cut-off value of 17.8°. Aortic LZ curvature and angulation significantly affected final TAVI implantation depth, especially in high stent-frame SE devices reporting, upon complete release, deeper implantation depth with respect to the intended one

Стан та перспективи конкурентоспроможності галузі національного господарства в умовах глобалізації

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

Mitral Valve Transcatheter Edge-to-Edge Repair:1-Year Outcomes From the MiCLASP Study

Background: Mitral transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post-market setting have not been established. Objectives: The authors report 30-day and 1-year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post-market clinical follow-up study. Methods: Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee–adjudicated 30-day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory–assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Results: A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30-day composite major adverse event rate was 6.8%. MR reduction was significant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR ≤2+ and 82.6% MR ≤1+ (all P &lt; 0.001 vs baseline). One-year Kaplan-Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Significant functional and quality-of-life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4-point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6-minute walk distance (all P &lt; 0.001 vs baseline). Conclusions: One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post-market setting. Results demonstrate high survival and freedom from heart failure hospitalization, significant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life.</p

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

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 &lt;75 years. Methods and results: We retrospectively analyzed 172 patients &lt;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 &lt;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

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

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

Mitral Valve Transcatheter Edge-to-Edge Repair

http://dx.doi.org/10.13039/100006520 Edwards Lifesciences Corporatio

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

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