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Updated: Nov 1, 2025

In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
The impact of COVID-19 pandemic on vascular registries and clinical trials
Faisal Aziz1, Christian-Alexander Behrendt2, Kaity Sullivan3
1Integrated Vascular Surgery Program, Penn State Health Heart and Vascular Institute, Hershey, PA.
Insights
The COVID-19 pandemic disrupted vascular quality improvement and clinical trials, leading to reduced procedure volumes and delayed research. Registries adapted by collecting COVID-19 data, revealing worse outcomes for infected surgical patients.
Area of Science:
- Vascular Surgery
- Epidemiology
- Public Health
Background:
- The COVID-19 pandemic significantly disrupted healthcare, impacting quality improvement programs and clinical trial research.
- Vascular registries observed immediate declines in procedure volumes across Europe and the United States during the pandemic's initial phase.
Purpose of the Study:
- To assess the magnitude and impact of the COVID-19 pandemic on vascular registries and clinical trials.
- To describe the pandemic's effect on multiple international vascular registries and collaborative efforts.
Main Methods:
- Surveys were distributed to vascular specialists for needs assessment.
- COVID-19 variables were integrated into vascular registry data collection forms.
- Disease-specific vascular surgery study collaboratives were established to focus on COVID-19 research.
Main Results:
- Over 80% of clinical trials experienced delays or were halted due to enrollment issues and patient safety concerns.
- Preliminary data indicate inferior outcomes (morbidity) and increased mortality in vascular surgery patients with active COVID-19 infection.
- International collaboration through VASCUNET and the Vascular Quality Initiative was highlighted.
Conclusions:
- Vascular registries demonstrated flexibility by incorporating COVID-19 data collection.
- The pandemic necessitated rapid adaptation in vascular research and quality improvement.
- Vascular registries must remain adaptable to address future real-world challenges impacting patient care.
Abstract:
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.
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