The impact of COVID-19 pandemic on vascular registries and clinical trials.

Quality improvement programs and clinical trial research experienced disruption due to the coronavirus disease 2019 (COVID-19) pandemic. Vascular registries showed an immediate impact with significant declines in second-quarter vascular procedure volumes witnessed across Europe and the United States. To better understand the magnitude and impact of the pandemic, organizations and study groups sent grass roots surveys to vascular specialists for needs assessment. Several vascular registries responded quickly by insertion of COVID-19 variables into their data collection forms. More than 80% of clinical trials have been reported delayed or not started due to factors that included loss of enrollment from patient concerns or mandated institutional shutdowns, weighing the risk of trial participation on patient safety. Preliminary data of patients undergoing vascular surgery with active COVID-19 infection show inferior outcomes (morbidity) and increased mortality. Disease-specific vascular surgery study collaboratives about COVID-19 were created for the desire to study the disease in a more focused manner than possible through registry outcomes. This review describes the pandemic effect on multiple VASCUNET registries including Germany (GermanVasc), Sweden (SwedVasc), United Kingdom (UK National Vascular Registry), Australia and New Zealand (bi-national Australasian Vascular Audit), as well as the United States (Society for Vascular Surgery Vascular Quality Initiative). We will highlight the continued collaboration of VASCUNET with the Vascular Quality Initiative in the International Consortium of Vascular Registries as part of the Medical Device Epidemiology Network coordinated registry network. Vascular registries must remain flexible and responsive to new and future real-world problems affecting vascular patients.

Reinterventions in the modern era of thoracic endovascular aortic repair.

OBJECTIVE: Using a national data set, we sought to describe the population of patients and the nature and timing of reinterventions after thoracic endovascular aortic repair (TEVAR) by aortic disease as well as their impact on survival. METHODS: We evaluated the national data set for TEVAR in the Vascular Quality Initiative from 2010 to 2017. Student t-test and χ2 analysis were used to compare continuous and categorical variables in the reintervention and no reintervention groups, respectively. Freedom from reintervention and survival analysis was performed using Kaplan-Meier methods. RESULTS: A total of 7006 patients were evaluated: 51.2% thoracic aortic aneurysm, 33.5% type B dissection (TBD), 7.0% penetrating aortic ulcer, 6.7% trauma, and 1.6% intramural hematoma. Overall, 553 patients (7.9%) underwent at least one reintervention, with an in-hospital reintervention rate of 3.5%. Reinterventions were most commonly performed for TBD (11.5%), with reinterventions for other diseases occurring at lower rates: thoracic aortic aneurysm, 6.7%; intramural hematoma, 5.4%; penetrating aortic ulcer, 4.8%; and trauma, 1.8%. The most common cause of reintervention across all aortic diseases was type I endoleak. The most common long-term reinterventions were placement of endovascular stent graft (65%), other surgical treatments (15.9%), other endovascular treatment (13%), endovascular branch treatment (12.4%), surgical treatment with no device removal (11.0%), and surgical branch treatment (10.4%). Freedom from reintervention was decreased for TBD compared with other diseases (P < .001). There was no difference in survival comparing patients undergoing reinterventions and those without (P = .87). However, patients undergoing in-hospital reintervention trended toward increased mortality (P = .075). CONCLUSIONS: Whereas reinterventions were not rare after TEVAR, there was no difference in mortality between patients undergoing reintervention and those without. Patients undergoing TEVAR for TBD demonstrated the highest reintervention rate. This study highlights the importance of long-term follow-up to address disease-specific patterns of reintervention.

Thirty-day outcomes from the Society for Vascular Surgery Vascular Quality Initiative thoracic endovascular aortic repair for type B dissection project.

OBJECTIVE: The purpose of the Society for Vascular Surgery Vascular Quality Initiative thoracic endovascular aortic repair (TEVAR) for dissection project is to assess the effectiveness of TEVAR for type B dissection by evaluation in a prospective quality improvement registry. Here we describe the project cohort and 30-day outcomes of TEVAR for both acute dissection (AD) and chronic dissection (CD) patients and focus specifically on outcomes of uncomplicated AD patients based on timing of treatment. METHODS: Summary statistics were performed comparing patients with AD (<30 days) and patients with CD. Both groups were further divided into those with complicated (ie, malperfusion or rupture) or uncomplicated presentation. Further subdivision of the uncomplicated AD patients into treatment at ≤48 hours, >48 hours to <7 days, ≥7 days to ≤14 days, and >14 days to <30 days was performed. Kaplan-Meier analysis was performed for 30-day survival and freedom from reintervention. RESULTS: Data for 397 patients (204 AD patients and 193 CD patients) were collected from 40 institutions. Overall, AD patients were younger than CD patients (58.8 vs 62.2 years; P = .003). Technical success, including coverage of the primary entry tear, was 98.0% for AD patients and 99.0% for CD patients, with a trend toward a higher 30-day mortality in AD patients (AD, 9.3%; CD, 5.2%; P = .126). Any degree of procedure-related spinal cord ischemia occurred in 4.4% of AD patients vs 2.1% of CD patients (P = .261), with a deficit at discharge in 3.4% of AD patients vs 0.5% of CD patients (P = .068). Disabling stroke occurred in 2.5% of AD patients vs 1.6% of CD patients (P = .725); retrograde type A dissection occurred in 1.1% of AD patients vs 2.6% of CD patients (P = .412). There was a trend toward a lower freedom from reintervention in AD patients (90.7% vs 94.8%; P = .13). In uncomplicated AD patients, rapid aortic expansion was more common in the treatment groups of ≥7 days to ≤14 days and >14 days to <30 days compared with those treated within 7 days of dissection (P = .042). The uncomplicated AD cohorts based on timing of treatment were otherwise similar in demographics and presentation, with no significant differences in 30-day mortality or serious complications, such as spinal cord ischemia, stroke, or retrograde type A dissection. The 30-day reintervention rate for uncomplicated AD patients was 5.8%, with no apparent differences in reintervention rates according to timing of treatment of initial TEVAR. CONCLUSIONS: As expected, AD patients demonstrated a trend toward a higher 30-day mortality and lower freedom from reintervention compared with CD patients. Mortality at 30 days after TEVAR for uncomplicated AD was 5.8%, and there were no clear patterns in mortality or reintervention based on timing of treatment. Further study and evaluation at longer follow-up are needed to determine the impact of timing of intervention in uncomplicated AD patients.