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Background: The Direct Flow Medical (DFM) valve is repositionable and retrievable. The non metallic inflatable and conformable design of the valve results in better sealing but in less radial force which may have an impact on stability and valve function over time. Aim of the study: To evaluate the 4-year clinical and echocardiographic outcome of the first generation 22F-DFM percutaneous aortic valve. Methods and results: From 2007 to 2008 31 symptomatic high-risk for surgery patients (mean age 82±4y) with severe aortic stenosis and a mean logistic EuroSCORE of 29±7% were the subject of this analysis. Clinical, echocardiographic and hemodynamic follow-up were obtained during 4 years. Survival rates were 81%, 69%, 60%, and 54% at 1,2,3,4 years, respectively. At 4 years, 83% of the patients, who survived, were in NYHA-class I, 17% in class II. Echocardiography revealed a significant decrease of the mean gradient from baseline (49.1±13.8 mmHg) to 30 days (19.1±6.8 mmHg, p < 0.001), which remained stable over 4 years. At 4-year follow-up, 80% of the patients had no aortic regurgitation, 20% had trace aortic regurgitation. Conclusions: In this preliminary series, the first generation of the nonmetallic, repositionable and retrievable 22F-DFM valve was associated with acceptable clinical outcome and stable hemodynamic performance with no aortic regurgitation in the majority of patients.

Background: The 18F Direct Flow Medical transcatheter aortic valve system is a next generation technology that has the potential to improve the outcome of TAVR. This design has conformable sealing rings which minimizes paravalvular aortic regurgitation (AR) and permits full assessment of valve performance prior to permanent implantation. Objectives: The DISCOVER Trial is a prospective, multicenter, non-randomized CE evaluation of the safety and performance of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the treatment of severe aortic stenosis in patients considered ineligible for surgery or at high risk for surgical complications. Methods: Patients were required to have a logistic EuroScore ≥ 20 or other high surgical risk features not reflected by the logistic EuroSCORE. Patients were reviewed by an independent Patient Review Committee consisting of cardiac surgeons and interventional cardiologists. Acute procedural, 6 and 12 month clinical and echocardiographic VARC defined outcomes are assessed. All echocardiographic and angiographic data are evaluated by an independent core laboratory (Medstar) and adverse events adjudicated by an independent clinical event committee. Results: At the time of abstract submission, 50 patients have been enrolled in the CE cohort. The average age was 84±5 (range of 71 to 94) years. The baseline logistic EuroSCORE was 27±12% (range: 2 – 55%) and STS score was 11.3±10.3%. Other baseline characteristics included: LVEF = 55.4±10%, 50% with CAD, 15% prior CABG, and 29% with CKD. A 25mm valve was used in 48% and 27 mm in 52%. There was 98% freedom from all cause mortality at 30 days. VARC defined 30 day patient safety freedom from events was 91% and device success was 97%. Core lab assessment of post procedure echocardiograms demonstrated 97% mild or less paravalvular AR and a mean gradient of 11.4±5.2 mmHg. 82% of the patients were reported in NYHA Class I/II at 30 days. The complete 6 month and available 12 month clinical and echocardiographic data will be presented. Conclusions: The Direct Flow Medical Transcatheter Aortic Valve System provides excellent acute and midterm results including virtual elimination of aortic regurgitation. This technology has the potential to provide next generation clinical outcomes. The complete 6 month and available 12 month hemodynamic and clinical data will be available at the time of presentation.

Objective: We aimed to identify factors predictive for new ipsi- and contralateral cerebral ischemic lesions during embolic protected carotid artery stenting (CAS). Background: Carotid endarterectomy and CAS appear to have similar overall perioperative stroke rates, which, however, may differ in specific patient subgroups. Knowledge of the risk factors for cerebral embolic events during CAS may impact treatment decisions for the individual patient, but have not been extensively studied. Aim of the study: To evaluate the risk factors for cerebral embolization after carotid artery stenting with embolic protection. Methods: Out of 837 consecutive patients undergoing CAS with cerebral embolic protection pre- and post-procedural diffusion weighted magnetic resonance imaging (DW-MRI) was performed for evaluation of new cerebral ischemic lesions in 728 patients (86.9%). Multivariate logistic regression analyses were performed to identify factors predictive for embolic events. Results: New ischemic lesions were found in 32.8% of the patients. Age, hypertension, lesion length, lesion excentricity, and aortic arch type III were significantly associated with new ischemic lesions, calcified lesions were negatively associated. In 25% of patients with embolic events lesions were also found in the contralateral hemisphere. Predictive factors for contralateral lesions were age, > 50% stenosis of the contralateral internal carotid artery, and an aortic arch type II, with a trend for aortic arch type III. Conclusions: Age, hypertension, lesion morphology, and aortic arch type were predictive for procedural related cerebral embolic events during embolic protected CAS. Age, significant contralateral carotid stenosis and complex aortic arch type were predictive for contralateral ischemic events. These findings may help to find the optimal treatment decision for the individual patient with carotid artery stenosis.