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The aim of the study was to evaluate the transcatheter aortic valve replacement (TAVR) in high-risk patients with severe bicuspid aortic valve (BAV) stenosis and to compare the outcomes with a matched group of patients with tricuspid aortic valve. TAVR became an alternative treatment method in high-risk patients with symptomatic aortic stenosis; however, BAV stenosis is regarded as a relative contraindication to TAVR. The study population comprised 28 patients with BAV who underwent TAVR. BAV was diagnosed based on a transesophageal echocardiography. CoreValve and Edwards SAPIEN prostheses were implanted. The control group consisted of 84 patients (3:1 matching) with significant tricuspid aortic valve stenosis treated with TAVR. There were no significant differences between patients with and without BAV in device success (93% vs 93%, p = 1.0), risk of annulus rupture (0% in both groups), or conversion to cardiosurgery (4% vs 0%, respectively, p = 0.25). The postprocedural mean pressure gradient (11.5 ± 6.4 vs 10.4 ± 4.5 mm Hg, p = 0.33), aortic regurgitation grade ≥2 of 4 (32% vs 23%, p = 0.45), 30-day mortality (4% vs 7%, p = 0.68), and 1-year all-cause mortality (19% vs 18%, p = 1.00) did not differ between the groups. Echocardiography showed well-functioning valve prosthesis with a mean prosthetic valve area of 1.6 ± 0.4 cm2 versus 1.7 ± 0.3 cm2 (p = 0.73), a mean pressure gradient of 10.3 ± 5.4 versus 9.8 ± 2.8 mm Hg (p = 0.64), and aortic regurgitation grade ≥2 of 4 (22% vs 22%, p = 1.00) for the 2 groups. In conclusion, selected high-risk patients with BAV can be successfully treated with TAVR, and their outcomes are similar to those reported in patients without BAV.

Subclinical leaflet thrombosis is an imaging phenomenon observed after transcatheter aortic valve implantation (TAVI) and characterized by hypoattenuating leaflet thickening (HALT) on computed tomography angiography. The clinical implications and underlying causes remain uncertain. Hypercoagulability, a component of Virchow’s triad, may contribute to thrombus formation on bioprosthetic leaflets, but data on hypercoagulable disorders in TAVI patients and their impact on HALT are limited. The PROSTHESIS study (Prothrombotic States in Transcatheter Heart Valve Subclinical Leaflet Thrombosis) is a single-center observational cohort study aiming to include 130 TAVI patients. This pilot study aimed to (i) assess the effect of hypercoagulable disorders on HALT prevalence and (ii) evaluate their impact on the natural history of HALT. Patients were screened for common hypercoagulable disorders using genetic and functional assays and underwent multimodal imaging one year after TAVI to detect HALT. In patients with HALT, post-implant imaging was repeated after three months to assess its progression. Early results comparing 52 TAVI patients with 52 matched controls undergoing coronary angiography showed similar thrombophilia prevalence between the groups (16% vs. 12%, p = 0.565). HALT occurred in 15% of TAVI patients, more extensively in those with thrombophilia (712 mm3 vs. 135 mm3, p = 0.036). However, thrombophilia was not an independent predictor of HALT. One-year follow-up CTA revealed spontaneous HALT resolution in 63%, stability in 25%, and progression in 12%. This study aims to provide insights into HALT and its mechanisms, which may help prevent complications and improve bioprosthesis durability.

Transcatheter aortic valve implantation (TAVI) is an established treatment for aortic stenosis (AS) in patients at increased surgical risk. Up to 29% of patients annually experience major adverse cardiac and cerebrovascular events (MACCE) after TAVI. MicroRNAs (miRNA) are currently widely investigated as novel cardiovascular biomarkers. The aim of this study was to determine the influence of TAVI on the expressions of selected miRNAs associated with platelet function (miR-125a-5p, miR-125b and miR-223), and evaluate the predictive value of these miRNAs for MACCE in 65 patients undergoing TAVI. Venous blood samples for miRNA expression analysis were collected 1 day before TAVI and at hospital discharge. The expression of miR-223, miR-125a-5p, miR-125b was evaluated in platelet-depleted plasma. The expression of miR-223 and miR-125b increased after TAVI, compared to the measurement before (p = 0.020, p = 0.003, respectively). Among 63 patients discharged from the hospital, 18 patients experienced MACCE (29%) during the median 15 months of observation. Baseline low miR-223 expression was a predictor of MACCE in univariate Cox regression analysis (hazard ratio [HR]: 2.71, 95% confidence interval [CI]: 1.04-7.01; p = 0.041). After inclusion of covariates, age, gender (male), New York Heart Association class and diabetes into the multivariate Cox regression model, miR-223 did not reach statistical significance (HR: 2.56, 95% CI: 0.79-8.33; p = 0.118). To conclude, miR-223 might improve risk stratification after TAVI. Further studies are required to confirm the clinical applicability of this promising biomarker.

BackgroundThe aim of this study was to evaluate the outcomes of transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BiAV) stenosis using a mechanically expanded Lotus™ device. The prior experience with first-generation devices showed disappointing results mainly due to increased prevalence of aortic regurgitation (AR) that exceeded those observed in tricuspid stenosis.Methods and resultsWe collected baseline, in-hospital, 30-day and 2-year follow-up data from a prospective, multicentre registry of patients with BiAV undergoing TAVI using Lotus™ valve. Safety and efficacy endpoints were assessed according to VARC-2 criteria. The study group comprised 24 patients. The mean age was 73.5 years and the mean EuroSCORE 2 was 4.35 ± 2.56%. MDCT analysis revealed Type 1 BiAV in 75% of patients. The mean gradient decreased from 60.1 ± 18.3 to 15 ± 6.4 mm Hg, the AVA increased from 0.6 ± 0.19 to 1.7 ± 0.21 cm2. One in-hospital death was observed secondary to aortic perforation. There was no severe AR and the rate of moderate AR equalled 9% at 30 days (n = 2). Device success was achieved in 83% and the 30-day safety endpoint was 17%. In the 2-year follow-up, the overall mortality was 12.5% and the 2-year composite clinical efficacy endpoint was met in 25% of the patients (n = 6)ConclusionsThe TAVI in selected BiAV patients using the Lotus™ is feasible and characterized by encouraging valve performance and mid-term clinical outcomes.Graphic abstract

Bicuspid aortic valve (BAV) stenosis has traditionally been perceived as a contraindication to transcatheter aortic valve implantation (TAVI) due to its specific anatomical characteristics including extensive calcifications, high leaflet coaptation and frequently encountered aortic root dilation, which may result in worse procedural outcomes and higher risk of complications. Hence, BAV patients were not included in previous clinical trials. In the recent years, improved pre-procedural imaging and technological advances have gradually enabled expansion of TAVI to patients with complex anatomy, including those with BAV. Moreover, indications for TAVI are expanding to a younger group of patients with fewer comorbidities, and BAV is more prevalent in this population. Contemporary multicenter registry-based studies indicate that patients undergoing TAVI for BAV have similar outcomes as those with tricuspid aortic valve stenosis. In this article, we provide a thorough overview of the available clinical data regarding the outcomes of TAVI in BAV, from the perspective of an experienced TAVI center with over 150 TAVIs in this group of patients, performed in our institution since the year 2009. We present anatomical and clinical classifications of BAV, differences in outcomes in patients with bicuspid and tricuspid valves, as well as important topics regarding choice of an adequate valve and valve size.

Intestinal microbial metabolites, such as trimethylamine-N-oxide (TMAO) and indoxyl sulfate (IS), have been suggested as markers for the progression of aortic stenosis (AS). However, the impact of transcatheter aortic valve implantation (TAVI) on these intestinal bacterial metabolites has not been evaluated in a multicenter clinical study. The aim of this study was to determine the effect of TAVI on plasma levels of intestinal bacterial metabolites and to assess the predictive value of these metabolites for major adverse cardiovascular events (MACE) following TAVI. M: ETHODS: Consecutive patients with AS referred for TAVI were enrolled in this study. Blood samples were collected one day before TAVI and at hospital discharge. The concentrations of intestinal microbial metabolites were measured using ultra performance liquid chromatograph coupled with a mass spectrometer. Plasma levels of TMAO and IS decreased after TAVI, compared to baseline (p ≤ 0.004 for all). Among 128 patients included in the study, 21 patients (16.4%) developed MACE during the median follow-up time of 404 days. Baseline plasma IS level was higher in patients with MACE, compared to those without MACE (p = 0.001). Increased baseline IS level predicted MACE with 75.0% sensitivity and 74.3% specificity independent of other clinical variables (OR 14.264, 95% CI 3.442-59.117, p < 0.001) and decreased the chance of event-free survival (plog rank < 0.001). Plasma concentrations of TMAO and IS decreased after TAVI, compared to baseline. Elevated plasma IS levels were associated with a 14-fold increase in the odds of post-TAVI MACE during a median follow-up period of 404 days.

Objectives: The aim of this study is to evaluate the safety and efficacy of repeat transcatheter aortic valve implantation (redo-TAVI) in the polish population. Methods: In this multicentre nationwide registry (ClinicalTrials.gov identifier, NCT03361046), we provide characteristics, periprocedural variables and long-term outcomes of high-risk patients who underwent redo-TAVI. Results: The mean age among 32 individuals who underwent redo-TAVI was 75 ± 13 years, and 62.5% were male. The mean time from index TAVI to redo-TAVI was 4.7 ± 3.5 years, with failed procedures (up to 1 year) occurring in 7 (21.9%) and failed transcatheter heart valve (THV, beyond 1 year) in the remaining majority of the 25 (78.1%) patients. Computed tomography-based native bicuspid aortic anatomy was found frequently in 37.5% of cases (58.3% in failed procedures and 41.7% in failed THV). The mean failed THV size was large (27.7 ± 3 mm) and predominantly presenting with pure regurgitation (59.4%). In more than two-thirds (68.7%), balloon-expandable or self-expandable THV was the most common strategy of redo-TAVI. None or mild regurgitation was found in 90.6%, and the mean transvalvular gradient was 13.1 ± 5.5 mmHg, with only three cases with >20 mmHg of the residual gradient (9.4%). Peri-procedural and 30-day complications were low, and cardiovascular and all-cause mortality at 1 year was 9.4 and 15.6%, respectively. There was a relatively high incidence of non-procedural stroke after redo-TAVI (n = 5, 15.6%), with all cases observed after 30 days. Conclusions: Initial data of redo-TAVI in Poland suggest that the procedure is safe and characterized by favourable efficacy and low rates of short-term adverse outcomes. A high frequency of baseline native bicuspid anatomy and late stroke occurrence after the redo-procedure warrants further investigation in larger cohorts.

Introduction:transcatheter aortic valve implantation (TAVI) raises questions regarding the safety and efficacy of TAVI in this subset of patients.Aim:To evaluate the impact of previous coronary revascularization in terms of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) on clinical outcomes after TAVI.Material and methods:A total of 507 consecutive patients who underwent TAVI were divided into: non-revascularization (NR), post-PCI and post-CABG groups. The endpoints were established according to VARC-2 definitions.Results:Patients with previous coronary revascularization (36.7% of the population) were younger, more often male and their EuroSCORE II risk evaluation was significantly higher (NR 7.9% vs. post-PCI 8.0% vs. post-CABG 20.5%, p < 0.0001). Patients after PCI or CABG prior to TAVI had similar 30-day all-cause mortality rates as those without coronary revascularization at baseline (NR vs. post-PCI vs. post-CABG: 8.1% vs. 5.5% vs. 6.8%, respectively; p = 0.6). There were no differences in 12-month all-cause mortality rates between groups (NR vs. post-PCI vs. post-CABG: 15.3% vs. 14.2% vs. 16.9%, respectively; log-rank p = 0.67). In the Cox proportional-hazards regression model, acute kidney injury stage 2-3 (HR = 3.7, 95% CI: 2.14–6.33; p < 0.001) and post-TAVI stroke (HR = 3.5, 95% CI: 1.57–7.8; p = 0.002) were independently correlated with 1-year mortality.Conclusions:TAVI seems to be a safe and effective procedure for the treatment of severe AS in patients with previous coronary revascularization.