Combined primary subintimal and endoluminal angioplasty for ischaemic inferior-limb ulcers in diabetic patients: 5-year practice in a multidisciplinary 'diabetic-foot' service.

Abstract

This study aims to assess the patency, the clinical success and the limb-salvage rates of combined subintimal (SA) coupled to endoluminal angioplasty (EA) as the initial treatment of ischaemic inferior-limb ulcers in diabetic patients and to study the influence of other concurrent factors in the tissue-healing process. Since September 2002 until December 2007, a consecutive series of 176 limbs with manifold ischaemic wounds in 161 diabetic patients were treated by associated multilevel angioplasties in a multidisciplinary 'diabetic-foot team' (a third-line diabetic-care institution integrating two departmental hospitals). There were 98 associated SA with EA procedures, 26 re-vascularisations by single SA technique and 52 others including selective multilevel EAs that were retrospectively reviewed. The mean follow-up period was 22.1 months (in the range of 1-50 months) by clinical and duplex evaluation (every 6 months). The initial technical success was noted in 149 limbs (84%). For the single or associated SA procedures, 102 of 124 procedures were successful (82%) and 145 of 150 of the miscellaneous EAs (96%) evinced an equally favourable outcome. The 27 initially failed endovascular procedures (22 SA and five EA) required 16 surgical re-vascularisation, eight adjuvant endovascular procedures besides three amputations. A total of 21 secondary and five tertiary angioplasties were equally necessary during the entire follow-up period of these patients. The 30-day survival rate was 99% (one patient died from myocardial infarction). In a intention-to-treat analysis, the cumulative primary and secondary patencies at 12, 24, 36 and 48 months were 62%, 45%, 41% and 38%, together with 80%, 69%, 66% and 66%, respectively. The aggregate clinical success rates at the same intervals were 86%, 77%, 70% and 69%, while the corresponding limb-salvage proportions showed 89%, 83%, 80% and 80%, respectively. The primary patency was negatively affected at 1 and 4 years by the length of the occluded segment (>10 cm) and the end-stage renal disease (ESRD) (p<0.0001). The limb-salvage rates were unfavourably influenced at the same periods by the extent of tissue defects (>3 cm), the ESRD and the presence of osteomyelitis. In addition, at 4 years, the age (>70 years), the accompanying peripheral neuropathy, the bedridden status and the presence of cardiac failure (left ventricular ejection fraction (LVEF)<30%) appeared equally as negative predictors (p<0.0001) for wound healing and limb rescue. Primary angioplasty represents a low aggressive and efficacious method to improve the healing process in diabetic ischaemic ulcers. However, beyond appropriate re-vascularisation, even repetitive if necessary, achieving satisfactory limb-salvage rates probably implies a multidisciplinary control of the presenting risk factors for wound healing as well.