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OBJECTIVES The ACURATE TA™ Aortic Bioprosthesis and Delivery System (Symetis S.A., Ecublens, Switzerland) is a new transcatheter aortic valve designed for transapical implantation. The six-month results from the completed first-in-man study are reported. METHODS The Symetis ACURATE TA™ is composed of a porcine biological tissue valve attached to a self-expandable nitinol stent. It allows for anatomical orientation and facilitates intuitive implantation providing tactile feedback. Since November 2009, a total of 40 high-risk elderly patients have been treated. RESULTS The mean age of enrolled patients was 83.2 ± 4.0; 60.0% were female, with a mean logistic EuroSCORE of 21.2 ± 10.8% and a mean Society of Thoracic Surgeons (STS) score of 9.0 ± 4.7%. All implants were delivered successfully in the intra-annular and subcoronary position. One patient was converted to conventional surgery due to coronary impingement (after valve-in-valve implantation). One additional patient received valve-in-valve treatment (SAPIEN THV TA™). Five patients expired within 30 days and two additional patients expired during the 6-month follow-up due to non-valve-related causes resulting in a mid-term survival rate of 82.5%. Two patients suffered a stroke and another three required new onset pacemaker implantation. The mean aortic gradient significantly improved and remained stable throughout the follow-up (baseline: 51.9 ± 14.3 mmHg, 30 days: 12.3 ± 5.1 mmHg, 6 months: 11.9 ± 5.8 mmHg). At the 6-month follow-up, 96.7% of patients demonstrated either none/trace or mild (1+/4) paravalvular leakage only. According to the Valve Academic Research Council the device's success rate was 92.5%, with a 30-day safety profile of 25%. CONCLUSIONS At the 6-month follow-up, the ACURATE TA™ device showed stable valve function with low rates of paravalvular leakages. The cohort of high-risk patients demonstrated good clinical outcomes and 6-month survival. [ABSTRACT FROM AUTHOR]

Background: The SYNTAX score was introduced to measure the complexity of coronary artery disease. Although a high SYNTAX score is indicative of a worse long-term outcome after percutaneous coronary intervention (PCI), it remains unclear whether it is also true for coronary artery bypass grafting (CABG)., Methods: We analyzed 200 consecutive CABG patients who underwent operations in 2002. Demographic and intraoperative data, perioperative outcomes, and 5-year outcomes were obtained. The SYNTAX score was calculated retrospectively by reviewing the original diagnostic angiograms. After excluding patients who had undergone CABG or PCI treatment within 6 months before surgery, we included 154 patients in the study. Patients were partitioned into tertiles according to the SYNTAX score (low, < or =18; intermediate, >18-26; high, >26). Cox regression analysis was used to identify baseline and procedural predictors for the combined end point of 5-year major adverse cardiac and cerebrovascular events (MACCE) and its components. Cumulative event rates were estimated by Kaplan-Meier methods., Results: The mean (+/-SD) age was 66.6 +/- 8.5 years, the mean ejection fraction was 56.4% +/- 13.6%, and the mean logistic EuroSCORE was 4.2% +/- 4.7%. The SYNTAX score ranged between 2 and 52. The overall survival rate was 94.8% at 1 year and 84.1% at 5 years. The rate of freedom from MACCE was 92.9% and 78.0% at 1 and 5 years, respectively. Only a higher EuroSCORE, a New York Heart Association class of III to IV, and smoking could be identified with Cox regression as risk factors for MACCE during follow-up. The overall survival and MACCE rates of the 3 SYNTAX score subgroups were not significantly different., Conclusions: Complex coronary pathology as measured by the SYNTAX score did not affect the long-term outcome after CABG in this study.