Evaluation of endovenous radiofrequency ablation and laser therapy with endoluminal optical coherence tomography in an ex vivo model.

BACKGROUND This study evaluated the ability of endovascular optical coherence tomography (eOCT) to detect qualitative tissue alteration and quantitative changes of vein wall thickness and vein lumen diameter comparing endovenous radiofrequency ablation (RFA) and endovenous laser therapy (ELT) in an established ex vivo model. METHODS Endoluminal eOCT was performed by means of a new prototype rotating system (System M1, LightLab Imaging Inc, Boston, Mass) with automatic pullback of 1 mm/s. In the course of an eOCT examination of a 50-mm vein segment, 264 electronic cross section images with a spatial resolution of 15 to 20 mum are acquired. The eOCT scans were performed before and after treatment of each of 13 treated vein segments and of six control vein segments. Thirteen subcutaneous cow foot veins were reperfused in situ, and the defined 50-mm vein segments in the study were treated with RFA (n = 2) and ELT (n = 11). RFA followed the clinical VNUS-Closure protocol (VNUS Medical Technologies, San Jose, Calif) using a 6F 60-mm Closure-Plus catheter. ELT was performed using light of lambda = 980 nm with a laser power of 3 (n = 2), 5 (n = 2), and 7 W (n = 4) with a paced pullback protocol with laser irradiation for 1.5 seconds every 3 mm, resulting in linear endovenous energy densities (LEED) of 15, 25, and 35 J/cm. Using 11 W (n = 3) with a continuous pullback protocol at 3 mm/s resulted in a LEED of 36.5 J/cm. Ten histologic cross sections of each treated and control vein segment were correlated with the corresponding eOCT cross sections to evaluate qualitative representation of vein wall layers and tissue alterations such as ablation and vein wall perforation. In addition, 26 eOCT cross sections of every treated vein segment before and after treatment and every control vein segment were analyzed to calculate quantitative changes in media thickness and vein lumen diameter. RESULTS In all specimens, qualitative analysis with eOCT demonstrated a clear match with histologic cross sections. A symmetrical, complete, circular disintegration of intima and media structures, without any transmural tissue defects, was shown after RFA. Pronounced semicircular tissue ablations (3 to 14 per 50 mm) and complete vessel wall perforations (0 to 16 per 50 mm) were detected after ELT. The quantitative analysis demonstrated a significant (P < .0001) increase in intima-media thickness after RFA (37.8% to 66.7%) and ELT (11.1% to 45.7%). A significant (P < .0001) reduction of vessel lumen diameter (36.3% to 42.2%) was found after RFA. Owing to the limited number of treated vein segments and inhomogeneous baseline vein lumen diameters, no linear correlation between laser energy level and effects on tissue such as ablation/perforation, media thickening, or vein lumen diameter could be identified. CONCLUSIONS In our ex vivo cow foot model, eOCT is able to reproduce normal vein wall structures and endovenous acute thermal alterations, such as tissue ablation and vessel wall perforations. Endovenous eOCT images can also be analyzed quantitatively to measure media thickness or vein lumen diameter. Endovascular OCT could become a valuable alternative tool for morphologic investigation of tissue alterations after endovenous thermal procedures.