Objective: Physician-oriented outcomes, such as patency and amputation-free survival (AFS), have traditionally been markers of success following lower extremity revascularization. Previous studies have defined clinical success based on a composite of patient-centered outcomes and have shown this outcome to be achieved in less than 50% of patients, far lower than standard physician-oriented outcomes. The purpose of this study is to evaluate clinical success following lower extremity bypass (LEB) or peripheral vascular intervention (PVI) for tissue loss in diabetic patients treated in a multidisciplinary setting to better understand what factors are associated with success from a patient’s perspective.
Methods: All patients presenting to our multidisciplinary diabetic limb preservation service from July 2012 to January 2020 were enrolled in a prospective database. Patients who underwent either LEB or PVI for ulcer or gangrene were included in the analysis. Clinical success was defined as the composite outcome of secondary patency to the point of wound healing, limb salvage for one year, maintenance of ambulatory status for one year, and survival for six months. Secondary outcomes included one-year wound healing, patency, and AFS.
Results: A total of 134 revascularizations were performed in 131 patients, including 91 (68%) PVI and 43 (32%) LEB. Patients were more frequently male (64%) and black (61%), and 16% were dialysis-dependent. All patients had tissue loss (53% ulcer, 47% gangrene). There were 5 (3.7%) WIfI stage 1, 6 (6.0%) stage 2, 29 (22%) stage 3, and 92 (69%) stage 4 limbs at the time of revascularization. Overall, 76.9% of patients preserved secondary patency to the point of wound healing, 92.5% had limb salvage for one year, 90.3% had maintenance of ambulatory status for one year, and 96.3% survived for six months. The clinical success composite outcome was achieved in 71.6% of patients and was not statistically different between those undergoing PVI vs. LEB (69.2% vs. 76.7%, P = .37). Secondary patency, limb salvage, and AFS at one year were 80.8% ± 3.6%, 91.8% ± 2.3%, and 83.3% ± 3.1%, respectively. Wound healing at one year was 84.3% ± 3.4%. The only covariate associated with clinical failure on multivariable analysis was increased age (OR, 0.95; 95% CI, 0.91-0.99; P = .008).
Conclusions: Among diabetic patients presenting with tissue loss, the composite outcome of patient-centered clinical success is lower than traditional physician-centered outcomes following lower extremity revascularization, mostly due to low rates of secondary patency to the point of wound healing. In the current study, clinical failure was only associated with older age, and was no different following peripheral vascular intervention compared to lower extremity bypass.
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