The European Union (EU) Medical Device Regulation increased regulatory scrutiny to improve the safety and performance of new medical devices. An equally important goal is providing timely access to innovative devices to benefit patient care. The European Society of Cardiology strongly advocates for the evolution of the Medical Device Regulation system to facilitate priority access for innovative devices for unmet needs and orphan cardiovascular (CV) medical devices in EU countries. Although device approval is currently executed by Notified Bodies in the EU, it will be advantageous in the mid-term to consider a single EU regulatory agency for devices. In the short term, steps can be taken to transform the current system into a more efficient, predictable, cost-effective, and user-friendly service. Key strategies include the following: enhancing predictability of the approval process through use of early scientific advice from regulators; establishing unique regulatory pathways for CV orphan, paediatric, and innovative devices; promoting more efficient (re)certification of essential legacy CV devices; improving transparency of sponsor interactions with Notified Bodies; expanding the roles of the Expert Panels to assist in the approval of CV devices; promoting global regulatory harmonization, considering streamlined authorization of CV medical technologies across selected jurisdictions; developing an efficient system to monitor device safety; and ensuring funding for data collection platforms. Some strategies that could help include considering a pilot programme for joint approval processes of selected devices in partnership with other regions (i.e. US Food and Drug Administration); developing priority pathways for accelerated access to innovative or orphan devices; and increasing recognition of the importance of early feasibility studies in the EU.
Aims: The Assessment of left ventricular (LV) function remains a clinical challenge especially in patients with preserved LV ejection fraction (EF) and valvular heart diseases (VHD). Mechanical dispersion is supposed to be a strong predictor of events and, to be related to the extent of fibrosis. Regional cardiac work is a new validated and very promising approach to quantify LV-function. We investigated the differences in mechanical dispersions and global LV work (totW) and wasted work fraction (WWF) in normal subjects and in patients with severe primary mitral regurgitation (MR) and severe aortic stenosis (AS). Methods and Results: A complete transthoracic echocardiography was performed in 21 normal subject, 97 patients with severe valvulopathy (47 AS, 50 MR) and preserved LV EF. Segmental strain analysis was performed in all patients and the dispersion of regional LV strain curves was computed automatically considering peaks and integrals. The LV-pressure was estimated non-invasively using a standard waveform fitted to valvular events and scaled to systolic blood pressure. Using pressure-strain loops, regional cardiac work indices were computed. LVEF was 66±12 in controls, 65±9 in MR and 65±4% in AS (p=0.125). Global longitudinal strain was -23±2.7 in controls, -24±2.9 in MR and -18±3.2% in AS (p < 0.001). The mechanical dispersion was 38±7.9 in controls, 36±11 in MR, and much higher in the hypertrophied LV of the AS: 60±19ms (p < 0.001). Cardiac work was 2200±260 in controls, 2100±270 in MR, and much lower in AS: 1700±280 mmHg.% (p < 0.001). The wasted work fraction (WWF) was even more describing how different the LV systolic function is in the 3 groups (figure1). Abstract P697 Figure.
Transesophageal echocardiography (TEE) provides high quality 3D echocardiographic recordings in close proximity to the heart which is beneficial for interventions in the catheterization laboratory (cath lab) for both preprocedural planning and for monitoring the intervention. However, additional training and a certain level of operator expertise are required to master the maneuvering of the TEE probe in order to easily obtain consistent anatomical views. To ease these requirements, an anatomical view stabilization method is proposed. The stabilization method helps to visualize consistent TEE views without the need to repeatably maneuver the probe to the exact same position and orientation. The proposed method was tested on in-vivo data sets acquired from 5 patients pre, during or post intervention in the cath lab. Two validation approaches were performed offline, namely semi-quantitative scoring by two independent trained observers on the consistency of the anatomical views and quantitative measurements of the location and orientation of 3 manually annotated landmark points at the aortic root. The results from both validation approaches showed significant improvement in the user scores and significant reduction in the landmark distances after stabilization. These results show the potential of the proposed method in increasing reproducibility of particular anatomical views in TEE imaging.
