First clinical trial of a self-expandable transcatheter heart valve in Japan in patients with symptomatic severe aortic stenosis.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) may be a viable solution for inoperable or high-risk patients with aortic stenosis (AS), providing the benefit of valve replacement without the associated risks of surgery. METHODS AND RESULTS: The prospective, multicenter MDT-2111 Japan Trial evaluated the efficacy and safety of a self-expandable TAV in patients with severe AS. A total of 55 patients were enrolled (October 2011 to October 2012). Mean age was 82.5±5.5 years; 30.9% male, 100% NYHA III/IV, and STS 8.0±4.2%. At 6 months, 91.7% of the iliofemoral patients had met the primary endpoint (an improvement of at least 1 NYHA class and an effective orifice area >1.2 cm(2) for iliofemoral patients). For all patients, freedom from all-cause mortality at 6 months was 90.8%. At 30 days, the Kaplan-Meier rate of major vascular complications was 10.9%, the rate of permanent pacemaker implantation was 22.2% and the rate of major stroke was 3.7%. The incidences of paravalvular regurgitation for all implanted patients at 6 months were: 38.3% (none), 25.5% (trace), 31.9% (mild), 4.3% (moderate), and 0.0% (severe). CONCLUSIONS: This is the first study to evaluate a self-expandable TAV in a Japanese patient population. The data show successful achievement of the study's primary objective and demonstrate the functional and anatomical effectiveness of the MDT-2111 TAV system.

Screening for chronic kidney disease in Australia: a pilot study in the community and workplace.

The pilot program Kidney Evaluation for You (KEY) was conducted in Australia to screen for chronic kidney disease (CKD). Targeting people at high risk (those with diabetes, hypertension, a first-degree relative with kidney failure, or age >50 years), KEY aimed to establish community-based screening protocols, assess efficacy in promoting changes in risk-factor management, and explore participant CKD awareness. KEY offered free cardiovascular and kidney checks using point-of-care testing for on-site pathology measurements (estimated glomerular filtration rate, hemoglobin A1c, cholesterol, hemoglobin, albuminuria), lifestyle assessment, and exit interviews. Participants were telephoned at 3 months to ascertain whether KEY advice had been followed. Community and health professional support was strong; 99% of participants rated involvement as beneficial. Of 402 high-risk individuals recruited, findings were suggestive of CKD in 20.4%. Of these, 69% had hypertension, 30% diabetes, and 40% elevated total cholesterol. All participants with CKD stage 3b or higher were aged >61 years. Overall, 58% of participants were referred to their primary care providers for further action; of these, 82% saw their doctors in the next 3 months and 94% discussed KEY results. Follow-up telephone contact was successful for 82% of participants. A change in management occurred for 67%. Thus, the KEY approach to early detection of CKD and selected referral of participants was largely successful.