The Diagnostic Gap: Clinical Implications of SFA disease under-treatment

Background

Fluoroscopy based diagnosis is a corner stone for interventions. Nevertheless, it has inherent shortcoming of two dimensional disease visualization. We postulated that limited plaque detection may lead to subsequent under-treatment.

Methods

In VISION trial 188 SFA lesions were treated with the first in class, OCT-guided atherectomy catheter, Pantheris which supports both, therapeutic intervention and real-time intravascular visualization. We investigated the differences between diagnostic lesion length as measured by fluoroscopy vs. the OCT guided treatment length.

Results

Diagnostic gap (OCT length – fluoroscopy length) was measured in the Pantheris treated lesions. Average of 19.5mm in diagnostic gaps were noted across all study lesions (p<0.0001). Diagnostic gaps suggest under-treatment at the proximal and distal edges of lesions when solely using fluoroscopy guidance.

We analyzed the correlation between diagnostic gap values in lesions that required TLR compared to the lesions which did not require TLR. Even with low TLR rate in VISION study (6.4%, 12/188 lesions), a trend towards reduced differences in the diagnostic gap in the TLR group vs. the non-TLR group was observed (10.6 mm vs. 20.0 mm, p=0.15).

Conclusion

The clinical implications of under-treated plaque burden at the lesion edge is significant and linked to risk of TLR in coronary interventions. To the best of our knowledge, this is the first clinical study to show the diagnostic gap and its correlation with TLR in PAD.

These findings also suggest that real-time OCT-guided atherectomy may enable pbnbnbrecise and complete plaque removal and thus improve long term patient outcomes.

The Diagnostic Gap: Clinical Implications of SFA disease under-treatment