ORIGINAL ARTICLES   

International Angiology 2000 March;19(1):18-25

Copyright © 2001 EDIZIONI MINERVA MEDICA

lingua: Inglese

Prospective study of transcutaneous oxygen tension (TcPO2) measurement in the testing period of spinal cord stimulation in diabetic patients with critical lower limb ischaemia

Petrakis E., Sciacca V.

From the 1st Department of General Surgery, Policlinico Umberto I, University of Rome “La Sapienza”, Rome, Italy

Background. Spinal cord stim­u­la­tion ­improves micro­cir­cu­la­to­ry blood flow, ­relieves dia­bet­ic neu­ro­path­ic and ischaem­ic pain and reduc­es the ampu­ta­tion rate in ­patients with ­severe periph­er­al arte­ri­al occlu­sive dis­ease. Aim: To eval­u­ate wheth­er trans­cu­ta­ne­ous oxy­gen ten­sion (TcPO2) meas­ure­ments can be used as a spe­cif­ic prog­nos­tic param­e­ter in the assess­ment of suit­abil­ity for per­ma­nent ­device implan­ta­tion in a pros­pec­tive con­trolled study on dia­bet­ic ­patients with periph­er­al arte­ri­al occlu­sive dis­ease.
Methods. Sixty ­patients (39 men, 21 women; mean age: 60 years; range: 46-75) were sub­mit­ted to implan­ta­tion of a spi­nal cord electri­cal gen­er­a­tor for ­severe periph­er­al vas­cu­lar dis­ease, after ­failed con­ser­va­tive or sur­gi­cal treat­ment. The clin­i­cal stat­us was clas­si­fied as Fontaine’s stage III and IV and the main pathol­o­gy was dia­bet­ic vas­cu­lar dis­ease. Pedal TcPO2 was ­assessed on the dor­sum of the foot and ankle and toe pres­sure Doppler meas­ure­ments were per­formed ­before, two weeks and four weeks after implan­ta­tion.
Results. Pain ­relief of over 75% and limb sal­vage were ­achieved in 35 dia­bet­ic ­patients, while in 12 a par­tial suc­cess with pain ­relief over 50% and limb sal­vage for at least 6 ­months was ­obtained. In 13 ­patients the meth­od ­failed and the affect­ed limbs were ampu­tat­ed. Clinical improve­ment and spi­nal cord stim­u­la­tion suc­cess were asso­ciat­ed with increas­es of TcPO2, with­in the first two weeks after implan­ta­tion (tem­po­rary peri­od). Limb sal­vage was ­achieved with sig­nif­i­cant ­increase of TcPO2 with­in the first two weeks of the test­ing peri­od (from 21.4 to 31.5 mmHg in rest pain ­patients, p=0.030, from 15.1 to 22.0 mmHg, p=0.030 in ­patients with troph­ic ­lesions under 3 cm2 in size and in those with troph­ic ­lesions over 3 cm2, from 12.1 to 17.9 mmHg, p=0.025) unre­lat­ed to the stage of the dis­ease and the ­initial TcPO2 value. TcPO2 chang­es were relat­ed to the pres­ence of ade­quate par­a­es­the­sias and ­warmth in the pain­ful area dur­ing the trial peri­od. The sys­tol­ic ankle/bra­chi­al blood pres­sure index and toe pres­sure did not ­change under stim­u­la­tion.
Conclusions. A two-week test­ing peri­od ­should be per­formed in all dia­bet­ic ­patients treat­ed with spi­nal cord stim­u­la­tion for periph­er­al arte­ri­al occlu­sive dis­ease to iden­ti­fy the can­di­dates for per­ma­nent implan­ta­tion. Only dia­bet­ic ­patients with sig­nif­i­cant increas­es of TcPO2 and clin­i­cal improve­ment, dur­ing the test peri­od, ­should be con­sid­ered for per­ma­nent implan­ta­tion and not mere­ly all ­patients with pain ­relief. TcPO2 chang­es could be used as a pre­dic­tive index of the ther­a­py suc­cess and ­should be con­sid­ered in terms of cost effec­tive­ness ­before the final deci­sion to per­ma­nent implan­ta­tion.