Real-world 6-month outcomes of minimally invasive aortic valve replacement with the EDWARDS INTUITY Elite valve system.

OBJECTIVES: We report on real-world safety and performance outcomes of minimally invasive rapid-deployment aortic valve replacement using the EDWARDS INTUITY Elite aortic valve system. METHODS: The study valve system was used in a European, prospective, multicentre post-market study. Various procedural, haemodynamic and clinical outcomes were evaluated through 6 months of post-implant. RESULTS: A total of 276 patients out of 280 (98.6%) enrolments were successfully implanted with the study valve using a minimally invasive approach between February 2016 and April 2017. Of these 276 patients, 240 (87%) underwent partial sternotomy and 36 (13%) patients underwent right thoracotomy. Mean cross-clamp time was 51.9 [standard deviation (SD): 16.0] min. From baseline to 6 months, the mean effective orifice area increased from 0.8 (SD: 0.3) to 1.8 (SD: 0.6) cm2 and the mean systolic gradient decreased from 46.0 (SD: 14.1) to 8.8 (SD: 3.7) mmHg. After 6 months, 70.7% and 26.4% of patients were in New York Heart Association class I and II, respectively. Freedom from death, major bleeding, major paravalvular leak, reoperation and device explant at 6 months were 96.0%, 98.5%, 98.8%, 99.2% and 99.2%, respectively. CONCLUSIONS: These results demonstrate that the study valve is a safe and effective choice for patients undergoing aortic valve replacement via minimally invasive surgery. NAME AND REGISTRATION OF REGISTRY: MISSION (Assessing clinical outcomes using the EDWARDS INTUITY Elite Valve System in isolated AVR using Minimally InvaSive Surgery In a EurOpean multi-ceNter, active, post-market registry). clinicaltrials.gov ID #NCT02907463.

Effect of hemostatic material on sternal healing after cardiac surgery.

BACKGROUND: Postoperative sternal infection and dehiscence cause increased morbidity, mortality, and socioeconomic costs as well as patient discomfort and pain. Some predisposing factors have been uncovered but others remain uninvestigated. Among these are the influence of topical hemostatic agents such as bone wax (BW) and Ostene (Ceremed Inc, Los Angeles, CA) a new, water-soluble polymer wax (WSW). The object of this study was to investigate the impact of topical hemostatic agents on sternal healing in patients. METHODS: In total, 50 patients subjected to elective cardiac surgery and requiring intraoperative hemostatic treatment were randomized to 1 of 2 treatment groups: BW or WSW. Twenty-five patients without need for sternal hemostasis constituted a control group. The doctors analyzing the endpoints were blinded to the treatment. Radiologic bone healing was assessed by a radiologist using computed tomography at 3 and 6 months postoperatively. Quality of life and bodily pain was assessed by questionnaires (Short Form-36 and Visual Analogue Scale). RESULTS: No patients displayed complete radiologic healing at 3 months. Bone healing (evaluated semi-quantitatively at a score from 0 to 10) was significantly impaired in the BW group compared with both the control and WSW groups at both 3 and 6 months postoperatively (p < 0.0001). Radiologic bone healing was positively correlated with physical functioning score (Short Form-36) (p < 0.001). Pain scores were generally low (<1) at both 3 and 6 months with no significant difference between study groups. CONCLUSIONS: The results from this study suggest that WSW provides a useful alternative to BW when topic hemostasis on the sternum is required.