Efficacy and safety of the Lotus Valve System for treatment of patients with severe aortic valve stenosis and intermediate surgical risk: Results from the Nordic Lotus-TAVR registry.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for patients with symptomatic, severe aortic valve stenosis (AS) who are ineligible or at high risk for conventional valvular surgery. In Northwestern Europe, the TAVR technology is also increasingly used to treat patients with an intermediate risk profile. METHODS AND RESULTS: The study was designed as an independent Nordic multicenter registry of intermediate risk patients treated with the Lotus Valve System (Boston Scientific, MA, USA; N=154). Valve Academic Research Consortium (VARC)-defined device success was obtained in 97.4%. A Lotus Valve was successfully implanted in all patients. There was no valve migration, embolization, ectopic valve deployment, or TAV-in-TAV deployment. The VARC-defined combined safety rate at 30days was 92.2%, with a mortality rate of 1.9% and stroke rate of 3.2%. The clinical efficacy rate after 30days was 91.6% - only one patient had moderate aortic regurgitation. When considering only those patients in the late experience group (N=79), the combined safety and clinical efficacy rates were 93.7% and 92.4%, respectively. The pacemaker implantation rate was 27.9% - this rate was 12.8% in case of a combined implantation depth <4mm and a device/annulus ratio<1.05. CONCLUSIONS: The present study demonstrates the efficacy and safety of the repositionable, retrievable Lotus Valve System in intermediate risk patients with AS. The VARC-defined device success rate was 97.4% with a 30-day patient safety and clinical efficacy rate of more than 90%. Less than moderate aortic regurgitation was obtained in 99.4% of patients.

Transcatheter versus surgical treatment for aortic stenosis: patient selection and early outcome.

OBJECTIVES: To describe short-term clinical and echocardiography outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). To explore patient selection criteria for treatment with TAVI. DESIGN: TAVI patients (n = 45) were matched to SAVR patients (n = 45) with respect to age within ± 10 years, sex and systolic left ventricular function. RESULTS: TAVI patients were older, 82 ± 8 versus 78 ± 5 years (p = 0.005) and they had higher logEuroSCORE, 16 ± 11% versus 8 ± 4% (p = 0.001). There were no significant differences in 30 days mortality, stroke and myocardial infarction. TAVI patients received less erythrocyte (53% vs. 78%, p = 0.03) and thrombocyte (7% vs. 27%, p = 0.02) transfusions. Postoperative atrial fibrillation was less common (18% vs. 60%, p = 0.001) in the TAVI group. Paravalvular regurgitation was more common in TAVI patients (87% vs. 0%, p = 0.001) and 27% had access site complications. Aortic transvalvular velocity was 2.3 ± 0.4 m/s versus 2.6 ± 0.5 m/s (p = 0.002) and mean valve pressure gradient was 12 ± 4 mmHg versus 15 ± 5 mmHg (p = 0.01) in the TAVI and SAVR groups, respectively. Twenty-nine (64%) of the TAVI patients had logEuroSCORE = 15%. CONCLUSIONS: Both TAVI and SAVR have good short term clinical outcome with excellent hemodynamic result. In clinical practice, factors other than high logEuroSCORE play an important role in patient selection for TAVI.

Aromatic plant production on metal contaminated soils.

Field and container experiments were conducted to assess the feasibility of growing aromatic crops in metal contaminated areas and the effect of metals on herbage and oil productivity. The field experiments were conducted in the vicinities of the Non-Ferrous Metals Combine (Zn-Cu smelter) near Plovdiv, Bulgaria using coriander, sage, dill, basil, hyssop, lemon balm, and chamomile grown at various distances from the smelter. Herbage essential oil yields of basil, chamomile, dill, and sage were reduced when they were grown closer to the smelter. Metal removal from the site with the harvestable plant parts was as high as 180 g ha(-1) for Cd, 660 g ha(-1) for Pb, 180 g ha(-1) for Cu, 350 g ha(-1) for Mn, and 205 g ha(-1) for Zn. Sequential extraction of soil demonstrated that metal fractionation was affected by the distance to the smelter. With decreasing distance to the smelter, the transfer factor (TF) for Cu and Zn decreased but increased for Cd, while the bioavailability factor (BF) for Cd, Pb, Cu, Mn, and Zn decreased. Scanning electron microscopy and X-ray microanalyses of contaminated soil verified that most of the Pb, Cd, Mn, Cu, and Zn were in the form of small (<1 microm) particles, although there were larger particles (1-5 microm) with high concentrations of individual metals. This study demonstrated that high concentrations of heavy metals in soil or growth medium did not result in metal transfer into the essential oil. Of the tested metals, only Cu at high concentrations may reduce oil content. Our results demonstrated that aromatic crops may not have significant phytoremediation potential, but growth of these crops in metal contaminated agricultural soils is a feasible alternative. Aromatic crops can provide economic return and metal-free final product, the essential oil.