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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

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.

Left atrial appendage closure (LAAC) with Watchman device prevents thromboembolism in patients with atrial fibrillation (AF). However, thrombus may develop on the atrial surface of the device. To investigate the incidence and predictors of device-related thrombus (DRT) in patients with AF who were treated with LAAC. Ninety-one consecutive patients with AF underwent LAAC procedure using first-generation Watchman 2.5 device followed by antiplatelet therapy. In our analysis we have included all patients ( = 78) who had clinical follow-up visits with transesophageal echocardiography (TEE) after the procedure. The median (IQR) CHA DS -VASc score was 4 (4.0-6.0) and HAS-BLED score was 3 (3.0-4.0). DRTs were observed in 5 (6.4%) patients. When compared with patients without DRT, those with DRT presented more often with lower median ejection fraction (40% (23.5-45.5) versus 55% (48.0-60.0); = 0.005), lower emptying velocity of LAA (25 cm/s (17.5-27.0) versus 53 cm/s (26.5-78.0); = 0.009), and with greater depth of implantation (18 mm (14.0-20.5) versus 8 mm (5.0-11.0); < 0.001). Furthermore, patients with DRT had greater depth of LAA (35 mm (29.5-41.0) versus 29 mm (25.5-31.0); = 0.003), greater mean (SD) dimension in 90 (22.4 mm (3.2) versus 19 mm (2.7); = 0.02). Patients with DRT were also younger than those without DRT (67.4 years (7) versus 75 years (8.3), = 0.045). The DRT after Watchman device implantation remains a rare complication. Its formation was related to several patient and procedural characteristics, which need to be confirmed in larger studies.

Both transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) have been proven to effectively correct von Willebrand Factor (vWF) pathologies, however there is limited data simultaneously comparing outcomes of both approaches. We prospectively enrolled patients with severe aortic stenosis referred for TAVI (n = 52) or SAVR (n = 48). In each case, vWF antigen (vWF:Ag), vWF activity (vWF:Ac) and activity-to-antigen (vWF:Ac/Ag) ratio were assessed at baseline, 24 h and 72 h after procedure. VWF abnormalities were defined as reduced vWF:Ac/Ag ratio (< 0.8). Bleeding events in both arms were classified according to Valve Academic Research Consortium (VARC-2) definitions. Overall, there was no difference between patients referred for TAVI and SAVR in vWF:Ac (1.62 ± 0.52 vs 1.71 ± 0.64; p = 0.593), vWF:Ag (1.99 ± 0.81 vs 2.04 ± 0.81; p = 0.942) or vWF:Ac/Ag ratio (0.84 ± 0.16 vs 0.85 ± 0.12; p = 0.950). Pathological vWF:Ac/Ag ratio was found in 20 (38%) TAVI and 15 (31%) SAVR patients (p = 0.407). Normalization of vWF:Ac/Ag ratio at day 3 after procedure was achieved in 19 (95%) TAVI and 13 (87%) SAVR patients (p = 0.439). Similar prevalence of major or life-threatening bleedings (MLTB) after TAVI and SAVR in entire groups was observed (19% vs. 23%, p = 0.652). VWF abnormalities were associated with higher incidence of MLTB in SAVR (53% vs 9%, p < 0.001), but not TAVI (15% vs. 22%, p = 0.132). Accordingly, in receiver-operating characteristic curve analysis vWF:Ac/Ag ratio < 0.8 showed significant sensitivity and specificity for predicting MLTB in SAVR group (AUC 0.735, 95% CI 0.538–0.931, p = 0.019). We proved that abnormal function of vWF is corrected successfully after both TAVI and SAVR, but vWF abnormalities are predictive of MLTB only in surgical patients.

Bleeding complications after transcatheter aortic valve implantation (TAVI) are an important issue and negatively affect survival. The rate and impact of protamine sulfate (PS) administration on bleeding complications after TAVI remain unclear. To assess the impact of PS on bleeding complications after TAVI. Between March 2010 and November 2016 two hundred fifty-eight patients qualified for TAVI in one academic center were screened. Baseline, procedural and follow-up data up to 30 days were collected and analyzed. The primary endpoint (PE) was major bleeding according to the Valve Academic Research Consortium up to 48 h after the procedure. Overall, 186 patients (96 females, mean age: 80 years) met the inclusion criteria. Thirty-nine (21%) subjects received PS. PE occurred in 24.7% of the study population. There were no significant differences in terms of the PE rate between the groups (25.6% in the PS group and 24.7% in the remaining cohort, = 0.9, odds ratio (OR) = 1.05, confidence interval (CI): 0.47-2.4, = 0.9). Multivariate analysis identified female gender (OR = 2.2, CI: 1.08-4.4, = 0.03) as an independent predictor of PE occurrence. Similarly, female gender (OR = 2, CI: 1.06-3.84, = 0.03) as well as general anesthesia (GA, OR = 2.23, CI: 1.13-4.63, = 0.02) and dose of unfractionated heparin per kilogram (UFH/kg, OR = 1.02, CI: 1-1.03 per 1 IU increment, = 0.02) predicted the occurrence of a composite of major and minor bleeding. In this analysis, PS administration did not decrease the PE rate. Female gender predicted PE occurrence. Randomized, placebo-controlled trials are required to accurately assess the impact of PS.

Paradoxical low-flow, low-gradient aortic stenosis (pLF-LGAS) constitutes an important part of the population undergoing transcatheter aortic valve implantation (TAVI). However, it remains the least defined subtype of aortic stenosis (AS). To investigate baseline characteristics and impact on mortality of pLF-LGAS in patients treated with TAVI. Two-hundred and thirty-one consecutive patients (mean aortic valve area: 0.76 ±0.41 cm ) who underwent TAVI in our centre during the period of 6 years were included in the study. Based on echocardiographic examination, patients with pLF-LGAS were identified, analysed and compared to a population with high-gradient AS (HGAS) and low-flow, low-gradient AS with reduced ejection fraction (classical, cLF-LGAS). The primary endpoints of the study were all-cause mortality after 30 days and 1 year. pLF-LGAS was diagnosed in 42 (18.2%) patients, whereas 40 (17.3%) had cLF-LGAS and 149 (64.5%) had HGAS. The pLF-LGAS population was younger, had higher prevalence of hypertension, and had higher ejection fraction (EF) than the HGAS population, and had a smaller proportion of heavily symptomatic patients than the cLF-LGAS population. Overall, 46 (19.9%) patients died within 12 months after TAVI. The 30-day and 1-year survival was comparable between AS subtypes. Multivariate analysis identified severe renal failure as an independent predictor of mortality among all patients. pLF-LGAS is common among subjects undergoing TAVI. Patients with paradoxical AS are younger, more often burdened with hypertension and have higher EF than the HGAS population, while being less symptomatic than the cLF-LGAS group. Presence of pLF-LGAS does not seem to affect short- and mid-term survival. Severe renal failure is an independent predictor of mortality after TAVI.

Patient-prosthesis mismatch (PPM) is relatively frequent after surgical aortic valve replacement (SAVR) and negatively impacts prognosis. We sought to determine the frequency and clinical effects of PPM after transcatheter aortic valve implantation (TAVI). Overall, 238 patients who underwent TAVI were screened. Moderate PPM was defined as indexed effective orifice area (EOAi) between 0.65 and 0.85 cm /m , and severe PPM as < 0.65 cm /m . All-cause mortality and the Valve Academic Research Consortium 2 (VARC-2) defined composite of clinical efficacy at 1 year were the primary endpoints. Finally, 201 patients were included (mean age: 79.6 ±7.4 years, 52% females). The femoral artery served as the delivery route in 79% and most of the prostheses were self-expanding (68%). Any PPM was present in 48 (24%) subjects, and only 7 (3.5%) had severe PPM. Body surface area (BSA) independently predicted any PPM (OR = 16.9, < 0.001) whereas post-dilation tended to protect against PPM (OR = 0.46, = 0.09). All-cause mortality was similar in patients with moderate or severe PPM as compared to those with no PPM (14.6% vs. 14.3% vs. 13.1%, respectively, log-rank = 0.98). Neither moderate (OR = 1.6, 95% CI: 0.8-3.2, = 0.16) nor severe PPM (OR = 1.67, 95% CI: 0.36-7.7, = 0.51) had a significant impact on composite endpoint, or its elements, with the exception of transvalvular pressure gradient > 20 mm Hg. Severe PPM after TAVI is rare, can be predicted by larger BSA and does not seem to affect mid-term mortality or composite clinical outcome. Larger studies are needed to find different independent predictors of PPM and elucidate its impact in terms of device durability and long-term clinical efficacy.

To date, there are no reported cases of the Amplatzer Duct Occluder II: Additional Sizes’ use in percutaneous closure of an aortopulmonary window. We report a case of percutaneous closure of an aortopulmonary window in a 4.5-month-old, 6 kg child. Owing to the patient’s low weight, high risk of damage to the pulmonary valve, as well as the possibility of aortic and pulmonary artery obstruction, classic implants were deemed unsuitable and a decision was made to use the Amplatzer Duct Occluder II: Additional Sizes. The implant performed very well – the soft waist filled the aortopulmonary connection and both retention discs were properly shaped and pressed against vessel walls. Echocardiogram performed 12 hours after the procedure confirmed a correct occluder position. Low-profile retention discs had no impact on pulmonary valve function, despite the defect’s proximity to the valve. No obstruction of the aortic or pulmonary artery lumen was noted. The Amplatzer Duct Occluder II: Additional Size implant is a safe and useful device for percutaneous closure of an aortopulmonary window in a carefully selected group of patients.

Coronary compression exclusion during right ventricle outflow tract stenting is recommended and potential oversight may be fatal. Balloon inflation in right ventricle outflow tract with simultaneous aortography can be inconclusive or falsely negative. We present a case of 27-year-old male post Ross operation qualified for percutaneous pulmonary valve implantation. Neither of the conventional views obtained provided a definite exclusion of coronary compression, therefore an intravascular ultrasound of the left coronary artery before and during balloon inflation in right ventricle outflow tract was performed. Acquired images allowed excluding potential constriction, thus a covered stent and pulmonary valve were implanted and the procedure was concluded. Two hours later, the patient complained of chest pain. Transthoracic echocardiography demonstrated a significant pericardial effusion. Retrospective analysis of the final angiogram revealed a possibility of subtle extravasation at the distal part of the homograft. A hybrid procedure consisting of additional covered stent implantation, pericardial drainage, and second pulmonary valve implantation was performed with an acceptable result. To conclude, in case of doubtful or unconvincing images obtained from aortography or selective angiography during balloon inflation in right ventricle outflow tract, intravascular ultrasound might be a feasible and useful technique. Signs of homograft rupture may be subtle, whereas symptoms of cardiac tamponade delayed. In selected patients percutaneous treatment of homograft rupture is achievable and beneficial.

Left ventricular hypertrophy (LVH) is a common compensating process in the pressure overload mechanism of aortic stenosis (AS). To identify a group of patients with a LVH pattern which may alter periprocedural and 1-year outcomes after transcatheter aortic valve implantation (TAVI). Echocardiographic examinations of 226 patients with severe AS treated with TAVI between March 2010 and February 2016 were retrospectively analysed and correlated with echocardiographic parameters and clinical outcomes in the study group. Ultimately 208 patients were enrolled in the study. Based on left ventricular mass index (LVMI) and relative wall thickness (RWT) patients were divided into three categories: concentric remodelling (CR), concentric hypertrophy (CH) and eccentric hypertrophy (EH). Most of the patients with severe AS referred for TAVI were found to have CH ( = 150, 72.8%), then EH ( = 33, 16%) and CR ( = 16, 7.8%). There were no significant differences between groups in terms of periprocedural outcomes or complications. After a mean observation time of 561.8 ±239.0 days, the observed all-cause mortality rate was 19.9%. After multivariable adjustment, CR remained associated with a higher risk of mortality (HR = 4.31; 95% CI: 1.607-11.538; = 0.004). Left ventricular hypertrophy is common in patients with severe AS prior to TAVI. The LVH pattern does not affect TAVI-related complications. In patients with severe AS referred for TAVI, CR seems to be the least favourable geometry of LVH, increasing the risk of 1-year all-cause death.