Elephant trunk simplifies thoracoabdominal aortic aneurysm repair without impacting operative risk.

BACKGROUND AND AIM: An open two-stage elephant trunk (ET) technique may aid in the technical ease of subsequent thoracoabdominal aortic aneurysm (TAAA) repair. We analyze whether the presence of an ET improves outcomes for patients undergoing extent I and II TAAA repair. METHODS: From September 1997 to October 2020, 469 patients underwent extent I or II TAAA repair. We compared those with prior ET to those without. Primary outcome was composite major adverse events (MAE) including operative mortality, myocardial infarction, permanent spinal cord injury, cerebrovascular accident, need for tracheostomy, and new need for dialysis. RESULTS: Thirty-eight (8.1%) patients had prior ET and 431 (91.9%) did not. There were no differences in baseline characteristics. The no ET group was more likely to undergo urgent or emergent procedures. Composite MAE occurred in 82 (19%) of the no ET group and 5 (15.8%) of the ET group (p = .785). Operative mortality was 5.5% and not significantly different between the groups (p = 1.00). No patients in the ET group experienced stroke or recurrent laryngeal nerve injury. Median partial bypass and cross-clamp times were significantly greater in the no ET group (28 [24-32] versus 19 [16-22] min; p ≤ .001 and 42 [32-53] versus 30 [25-39] min; p ≤ .001). CONCLUSIONS: Extent I and II TAAA repair after ET can be safely performed in a tertiary referral center with shorter bypass and cross-clamp times. ET eliminates the need for circulatory arrest or clamping a hostile arch.

Impact of the COVID-19 Pandemic on Non-COVID-19 Clinical Trials.

Randomized controlled trials (RCT) were impacted by the COVID-19 pandemic, but no systematic analysis has evaluated the overall impact of COVID-19 on non-COVID-19-related RCTs. The ClinicalTrials.gov database was queried in February 2020. Eligible studies included all randomized trials with a start date after 1 January 2010 and were active during the period from 1 January 2015 to 31 December 2020. The effect of the pandemic period on non-COVID-19 trials was determined by piece-wise regression models using 11 March 2020 as the start of the pandemic and by time series analysis (models fitted using 2015-2018 data and forecasted for 2019-2020). The study endpoints were early trial stoppage, normal trial completion, and trial activation. There were 161,377 non-COVID-19 trials analyzed. The number of active trials increased annually through 2019 but decreased in 2020. According to the piece-wise regression models, trial completion was not affected by the pandemic (p = 0.56) whereas trial stoppage increased (p = 0.001). There was a pronounced decrease in trial activation early during the pandemic (p < 0.001) which then recovered. The findings from the time series models were consistent comparing forecasted and observed results (trial completion p = 0.22; trial stoppage p < 0.01; trial activation, p = 0.01). During the pandemic, there was an increase in non-COVID-19 RCTs stoppage without changes in RCT completion. There was a sharp decline in new RCTs at the beginning of the pandemic, which later recovered.

Prevalence of gastroesophageal reflux in cystic fibrosis and implications for lung disease.

Gastroesophageal reflux (GER) is common in patients with cystic fibrosis (CF) and is often regarded as playing a role in the pathogenesis of CF lung disease. Individuals with CF have many predisposing factors to the development of GER, with a reported prevalence ranging from 35 to 81%. Several studies have suggested that patients with CF who have coexisting GER have more severe lung disease with lower pulmonary function and increased numbers of respiratory exacerbations. Furthermore, GER may alter the respiratory microbiology in CF. Both the acid and nonacid components of GER may have an effect on lung disease. More than 50% of U.S. patients with CF were being treated with proton pump inhibitors in 2012; however, data regarding safety and efficacy of these agents in CF are lacking. Pharmacologic and surgical treatment of GER may improve respiratory morbidity, although prospective controlled studies have not been performed. Given the lack of evidence-based guidelines for evaluation, diagnosis, and treatment of GER in CF, initiation of treatment for symptomatic GER should be based on standard guidelines for the general population. Because there is no clear evidence that GER leads to worse respiratory outcomes in CF or that treatment of GER improves pulmonary outcomes, invasive testing for GER in patients without reflux symptoms is not warranted. Further studies to determine the role of GER in CF lung disease and the risks and benefits of surgical and pharmacologic therapy for GER are warranted.