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Published on: November 19, 2019
Failure to achieve clinical improvement despite graft patency in patients undergoing infrainguinal lower extremity
Jessica P Simons1, Philip P Goodney, Brian W Nolan
1Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, Worcester, Mass 01655, USA.
Insights
Ten percent of patients with critical limb ischemia (CLI) did not improve symptomatically one year after infrainguinal bypass surgery, despite a patent graft. Dialysis dependence and inability to ambulate independently were key predictors of poor functional outcomes.
Area of Science:
- Vascular Surgery
- Critical Limb Ischemia (CLI)
- Lower Extremity Bypass
Background:
- Traditional studies on infrainguinal bypass for CLI focus on graft patency, limb salvage, and mortality.
- Functional outcomes, such as symptomatic improvement, are crucial for patient quality of life but less emphasized.
Purpose of the Study:
- To determine the proportion of CLI patients experiencing clinical failure (persistent symptoms or amputation) one year post-bypass, despite graft patency.
- To identify preoperative factors predicting this lack of symptomatic improvement.
Main Methods:
- Analysis of a prospectively collected database (Vascular Study Group of Northern New England, 2003-2007).
- Inclusion of patients undergoing elective infrainguinal lower extremity bypass for CLI with available long-term follow-up.
- Definition of primary endpoint as clinical failure (amputation or persistent ischemic symptoms) at 1 year with a patent graft.
- Multivariable logistic regression to identify independent predictors of clinical failure.
Main Results:
- Of 1012 patients, 788 (78%) had patent grafts at 1 year.
- 10% (79 patients) experienced clinical failure: 2.7% major amputations, 7.4% persistent rest pain or tissue loss.
- Dialysis dependence (OR, 3.74) and preoperative inability to ambulate independently (OR, 2.17) significantly predicted clinical failure.
- Prior coronary artery bypass graft or percutaneous coronary intervention showed a protective effect (OR, 0.52).
Conclusions:
- A significant minority (10%) of CLI patients with patent infrainguinal bypass grafts do not achieve clinical improvement within one year.
- Preoperative identification of patients at risk for poor functional outcomes remains challenging.
- Future research and clinical practice should integrate functional outcomes alongside traditional surgical endpoints for improved decision-making in CLI management.
Objective:
Studies of infrainguinal lower extremity bypass for critical limb ischemia (CLI) have traditionally emphasized outcomes of patency, limb salvage, and death. Because functional outcomes are equally important, our objectives were to describe the proportion of CLI patients who did not achieve symptomatic improvement 1 year after bypass, despite having patent grafts, and identify preoperative factors associated with this outcome.
Methods:
The prospectively collected Vascular Study Group of Northern New England database was used to identify all patients with elective infrainguinal lower extremity bypass for CLI (2003 to 2007) for whom long-term follow-up data were available. The primary composite study end point was clinical failure at 1 year after bypass, defined as amputation or persistent or worsened ischemic symptoms (rest pain or tissue loss), despite a patent graft. Variables identified on univariate screening (inclusion threshold, P < .20) were included in a multivariable logistic regression model to identify independent predictors.
Results:
Long-term follow-up data were available for 1012 patients who underwent infrainguinal bypasses for CLI, of which 788 (78%) remained patent at 1 year. Of these, 79 (10%) met criteria for the composite end point of clinical failure: 21 (2.7%) for major amputations and 58 (7.4%) for persistent rest pain or tissue loss. In multivariable analysis, significant predictors of clinical failure included dialysis dependence (odds ratio [OR], 3.74; 95% confidence interval [CI], 1.84-7.62; P < .001) and preoperative inability to ambulate independently (OR, 2.17; 95% CI, 1.26-3.73; P = .005). A history of coronary artery bypass graft or percutaneous coronary intervention was protective (OR, 0.52; 95% CI, 0.29-0.93; P = .03).
Conclusions:
After infrainguinal lower extremity bypass for CLI, 10% of patients with a patent graft did not achieve clinical improvement at 1 year. Preoperative identification of this specific patient subgroup remains challenging. To improve surgical decision making and the overall care of CLI patients, further emphasis needs to be placed on functional outcomes in addition to traditional surgical end points.
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