Background: The epidemic potential of coronavirus infection is now a reality. Since the first case detected in late 2019 in China, a fast worldwide expansion confirms it. The vascular patient is at a higher risk of developing a severe form of the disease because of its nature associating several comorbid states, and thus, some vascular surgery communities from many countries have tried to stratify patients into those requiring care during these uncertain times. Methods: This is an observational study describing the current daily vascular surgery practice at one tertiary academic hospital in Madrid region, Spaindone of the most affected regions worldwide due to the COVID-19 outbreak. We analyzed our surgical practice since March 14th when the lockdown was declared up to date, May 14th (2 months). Procedural surgical practice, organizational issues, early outcomes, and all the troubles encountered during this new situation are described. Results: Our department is composed of 10 vascular surgeons and 4 trainees. Surgical practice has been reduced to only urgent care, totaling 50 repairs on 45 patients during the period. Five surgeries were performed on 3 COVID-19-positive patients. Sixty percent were due to critical limb ischemia, 45% of them performed by complete endovascular approach, whereas less than 10% of repairs were aorta related. We were allocated to use a total of 5 surgical rooms in different locations, none our usual, as it was converted into an ICU room while performing 50% of those repairs with unusual nursery staff. Conclusions: The COVID-19 outbreak has dramatically changed our organization and practice in favor of urgent or semiurgent surgical care alone. The lack of in-hospital/ICU beds and changing nursery staff changed the whole availability organization at our hospital and was a key factor in surgical decision-making in some cases.
Purpose:To evaluate the safety and performance of the Treovance stent-graft.Methods:The global, multicenter RATIONALE registry (ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes.Results:Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related.Conclusion:The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.
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