Perkutane Interventionen an venösen Bypassgrafts mit Hilfe eines distalen Embolisationsschutzes am Beispiel des Percu-Surge-GuardWireTM-Systems

Distal embolization is a well known complication in percutaneous coronary intervention of saphenous vein graft stenoses. Recently, a guide wire has been developed with an inflatable balloon at the tip, which prevents distal embolization of material from degenerated and friable lesions into the microcirculation. The trapped material can be removed by an aspiration catheter. A first randomized trial (the SAFER-trial) has shown a significant reduction in major cardiac events using distal protection in saphenous vein graft interventions. Thus, the purpose of the present study was to assess retrospectively the outcome of saphenous vein graft interventions with and without the use of distal protection (PercuSurge-GuardWireTM-System) under routine conditions in a single center study. Thirty-eight consecutive patients with saphenous vein graft intervention using distal protection were compared with forty-two consecutive patients with standard vein graft angioplasty. No significant differences were found in postinterventional enzyme release (the difference of maximum CK-MB and CKMB before the intervention was 179 vs 316 U/l) or ECG changes (32 vs 29%). Coronary flow was assessed by the TIMI-frame-countmethod before and after the intervention. It showed no significant difference between the two groups. Finally, clinical follow-up for the endpoints death, reintervention, and rehospitalisation for cardiac cause showed no significant differences (RR 0,62, 1,46 and 1,24). In summary, this retrospective analysis did not confirm a general superiority of distal protection for saphenous bypass graft intervention. It appears that under routine conditions the absolute risk of distal embolization is relatively small at a centre with experienced operators. The present data do not justify the general use of a distal protection device in venous bypass graft intervention, especially in consideration of the considerable costs.-System) under routine conditions in a single center study. Thirty-eight consecutive patients with saphenous vein graft intervention using distal protection were compared with forty-two consecutive patients with standard vein graft angioplasty. No significant differences were found in postinterventional enzyme release (the difference of maximum CK-MB and CKMB before the intervention was 179 vs 316 U/l) or ECG changes (32 vs 29%). Coronary flow was assessed by the TIMI-frame-countmethod before and after the intervention. It showed no significant difference between the two groups. Finally, clinical follow-up for the endpoints death, reintervention, and rehospitalisation for cardiac cause showed no significant differences (RR 0,62, 1,46 and 1,24). In summary, this retrospective analysis did not confirm a general superiority of distal protection for saphenous bypass graft intervention. It appears that under routine conditions the absolute risk of distal embolization is relatively small at a centre with experienced operators. The present data do not justify the general use of a distal protection device in venous bypass graft intervention, especially in consideration of the considerable costs.