American Association for Thoracic Surgery

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.

Minutes matter for trauma patients in hemorrhagic shock. How trauma team function impacts time to the next phase of care has not been rigorously evaluated. We hypothesized better team performance scores to be associated with decreased time to the next phase of trauma care. This retrospective secondary analysis of a prospective multicenter observational study included hypotensive trauma patients at 19 centers. Using trauma video review, we analyzed team performance with the validated Non-Technical Skills for Trauma scale: leadership, cooperation and resource management, communication, assessment/decision making, and situational awareness. The primary outcome was minutes from patient arrival to next phase of care; deaths in the bay were excluded. Secondary outcomes included time to initiation and completion of first unit of blood and inpatient mortality. Associations between team dynamics and outcomes were assessed with a linear mixed-effects model adjusting for Injury Severity Score, mechanism, initial blood pressure and heart rate, number of team members, and trauma team lead training level and sex. A total of 441 patients were included. The median Injury Severity Score was 22 (interquartile range, 10-34), and most (61%) sustained blunt trauma. The median time to next phase of care was 23.5 minutes (interquartile range, 17-35 minutes). Better leadership, communication, assessment/decision making, and situational awareness scores were associated with faster times to next phase of care (all p < 0.05). Each 1-point worsening in the Non-Technical Skills for Trauma scale score (scale, 5-15) was associated with 1.6 minutes more in the bay. The median resuscitation team size was 12 (interquartile range, 10-15), and larger teams were slower ( p < 0.05). Better situational awareness was associated with faster completion of first unit of blood by 4 to 5 minutes ( p < 0.05). Better team performance is associated with faster transitions to next phase of care in hypotensive trauma patients, and larger teams are slower. Trauma team training should focus on optimizing team performance to facilitate faster hemorrhage control. Therapeutic/Care Management; Level III.

Adult congenital heart disease (ACHD) patients represent a growing population with increasing use of acute emergency department (ED) care. Providing comprehensive ED care necessitates an understanding of the most common clinical scenarios to improve morbidity and mortality in this population. The aim of this position document is to provide a consensus regarding the management of the most common clinical scenarios of ACHD patients presenting to the ED.

We aimed to investigate the prevalence of gastrointestinal bleeding (GIB) events in patients supported with HeartWare ventricular assist device (VAD) and activated lavare cycle. Thirty-two GIB events were documented in 22 patients (21%) after median support duration of 22 days (IQR: 11-157 days). There were 13 patients with early episodes of GIB. Meanwhile, 17 GIB events were documented in 9 patients after a median support duration of 174 days (IQR 25-736 days) (late bleeders), accounting for 0.18 events per patient's years. The GIB events appear to be a frequent complication in patients with HeartWare VAD regardless of the lavare cycle.