Reporting standards for endovascular surgery: should existing standards be modified for newer procedures?

Area of Science:

• Vascular Surgery
• Medical Device Reporting
• Clinical Trials

Background:

• Existing reporting standards for endovascular procedures require evaluation for adequacy.
• The Society for Vascular Surgery/International Society for Cardiovascular Surgery (SVS/ISCVS) and Society of Cardiovascular and Interventional Radiology (SCVIR) provide foundational guidelines.
• The increasing use of endovascular techniques necessitates standardized reporting for accurate assessment.

Purpose of the Study:

• To determine if current reporting standards are sufficient for endovascular procedures.
• To propose revisions and augmentations to existing standards based on SVS/ISCVS and SCVIR recommendations.
• To ensure objective and uniform data reporting for endovascular interventions.

Main Methods:

• Review and analysis of existing SVS/ISCVS and SCVIR reporting standards.
• Identification of areas requiring specific endovascular considerations (e.g., lesion description, complications).
• Integration of recommendations for endograft repair of abdominal aortic aneurysms (AAAs).

Main Results:

• SVS/ISCVS standards are adequate for outcome comparisons in occlusive disease, ensuring consistent assessment of open and endovascular methods.
• SCVIR recommendations are endorsed for reporting endovascular-specific complications (contrast, medication, device, entry site, deployment).
• Additional standards are needed for endograft treatment of aneurysmal disease, drawing from AAA repair guidelines and trial data.

Conclusions:

• Existing standards need augmentation to fully encompass endovascular procedures, particularly for aneurysmal disease.
• Standardized reporting is essential to prevent misleading information from premature data disclosures.
• Adoption of revised standards will enhance objectivity, uniformity, and progress in vascular surgery research.