PERIPROCEDURAL COMPLICATIONS
Table 3 summarizes overall periprocedural complications. 3 intra-procedural deaths occurred, all of which underwent laser extraction from a superior approach. The femoral group experienced lower 30-day mortality, although not statistically significant[2/49(4%) vs 33/372(9%);p=0.39].
Major complications(without intraprocedural death) were observed in 3% of patients undergoing TLE(14/421). Femoral bailout was associated with a higher percentage of major complications without intraprocedural mortality[5/49(10.2%) vs 9/369(2.4%);p=0.015]. We experienced 9 vascular and cardiac tears of which 4 were directly related to femoral approach tool deployment(none resulted in fatalities). Serious TR complications as a result of extraction occurred in 7 patients of whom only one patient required femoral TLE. Five minor complications(including pocket hematoma, femoral vein tear, pulmonary emboli, and minor TR) were encountered: 4 of which were associated with the femoral bailout group, compared to one in the superior approach group[4/49(8.2%) vs 1/372(0.3%);p<0.01].
Femoral bailout patients required more blood transfusion peri-procedurally[9/49 (18%) vs 14/372(3.8%);p<0.01], however, this did not translate into excess in mortality.
Extraction in occluded veins via a superior approach resulted in major complications in 16%[3/19(15.7%)] of the cases, while shifting to a femoral strategy in these patients did not result in additional major complications.