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To date, there is relatively little information related to the comparative effectiveness of intervention for patients with critical limb ischemia (CLI). Specifically, patient expectations after intervention are infrequently considered as a parameter of success when treating CLI. The purpose of this analysis is to examine a large cohort of patients undergoing intervention for CLI from the perspective of patient centered outcomes.
Methods: To understand patient expectations after vascular intervention, 102 consecutive patients undergoing a variety of elective operations (Mean age=65.4; male 60%; endovascular revascularization 44%; open surgery 56%) were prospectively administered a standardized preoperative questionnaire regarding their perceived need for surgery and the characteristics of a successful outcome postoperatively. The findings of that analysis were then applied retrospectively to a cohort of 954 consecutive patients (mean age 67.4, 58% male) undergoing intervention (57% open, 41% endo, 2% both) for CLI (37% rest pain, 37% ischemic ulceration, 26% gangrene). Patient centered success after intervention was felt to have occurred if all patient centered success outcomes were achieved. Next, using bivariate and multivariate analysis, a variety of patient variables were used to determine independent predictors and probability of patient centered success after intervention.
Results: Based on the findings of the standardized preoperative questionnaire, patient centered outcomes for success were defined as 1) maintenance of living independence, 2) maintenance of ambulatory status, 3) control/relief of pain, 4) no additional/non-routine physician visits and 5) survival for one year. While overall success for maintenance of independence was 89% (n= 849), maintenance of ambulation 84% (n= 802), control/relief of pain 48% (n= 461), no additional physician visits 36% (n= 340), and one-year survival 79% (n= 755), overall patient centered success (achievement of all five parameters) was accomplished in only 23% (n=218) of patients. Of 20 variables examined, only end-stage renal disease (OR [95%CI] 2.21[1.26-3.88]; p=0.006) and impaired ambulatory status preoperatively (OR [95%CI] 1.76 [1.12-2.79]; p=0.015) were independent predictors of failure using bivariate and multivariate analysis. Type of intervention (open versus Endo) was not a predictor of outcome. The probability of failing to achieve patient centered success was 88% in patients with end-stage renal disease, 83% in patients with impaired ambulatory status preoperatively and 93% in patients with both (representing 30% of the entire patient cohort). The probability of failure was still 73% even when neither predictor was present.
Conclusion: When allowing patients to define successful outcome after intervention for CLI, success was achieved in fewer than 25% of cases. Patients with end-stage renal disease and impaired ambulatory status rarely achieved success. These data reiterate that CLI is associated with declining overall health undeterred by vascular intervention and question whether intervention is an appropriate use of healthcare resources in various high risk cohorts.