Spinal cord stimulation in the treatment of non-reconstructable stable critical leg ischaemia: results of the European Peripheral Vascular Disease Outcome Study (SCS-EPOS).
OBJECTIVE
To determine the effect of spinal cord stimulation (SCS) on limb survival in patients with non-reconstructable critical leg ischaemia, and the value of patient selection on the basis of transcutaneous oxygen pressure (TcpO2) measurements and trial screening.


METHODS
A prospective, controlled, European multicentre study.


METHODS
Non-reconstructable patients with stable critical leg ischaemia were divided into three groups. The SCS-Match group comprised patients with a baseline forefoot TcpO2 of < 30 mmHg and both sufficient pain relief and sufficient paraesthesia coverage (> 75%) after a test stimulation period of at least 72 h. If baseline TcpO2 was < 10 mmHg, the TcpO2 should have exceeded 20 mmHg after test stimulation. The SCS-Match group was compared with patients not meeting these criteria, who were treated either with SCS (SCS-No-Match) or without SCS (No-SCS).


RESULTS
At baseline, the mean (+/- SD) supine TcpO2 was 14.9 +/- 8.3 mmHg in the SCS-Match group (n = 41), 11.3 +/- 13.3 mmHg in the SCS-No-Match group (n = 32) and 15.3 +/- 17.1 mmHg in the No-SCS group (n = 39). In the SCS-Match group a significant improvement in pain relief (p < 0.005) and TcpO2 (p < 0.001) was seen. After 12 months, cumulative limb survival of patients treated with SCS was significantly better than that of patients not treated with SCS (p < 0.03), and limb survival in the SCS-Match group was significantly higher (p < 0.03) than that in the SCS-No-Match and No-SCS groups (78, 55 and 45%, respectively).


CONCLUSIONS
SCS treatment of non-reconstructable critical leg ischaemia provides a significantly better limb survival rate compared with conservative treatment. Patient selection based on TcpO2 and the results of trial screening further increase the probability of limb survival after SCS therapy.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001785:Blood Gas Monitoring, Transcutaneous; D016638:Critical Illness; D004599:Electric Stimulation Therapy / Q000379:methods; D005260:Female; D006801:Humans; D007511:Ischemia / Q000097:blood / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013116:Spinal Cord