Author + information
- Vincent L. Rowe1,
- Leonardo Clavijo1,
- Fred Weaver1,
- Matthew Menard2,
- Kenneth Rosenfield3 and
- Alik Farber4
Evaluation and management of critical limb ischemia (CLI) has routinely been conducted by individual specialists capable of providing both diagnostic and therapeutic interventions in a single setting, with evaluation for surgical intervention or consultation from cross specialist as needed. During participation in the BEST-CLI study, our center modified the single practitioner approach to CLI treatment thereby transforming our practice into a two-step approach: utilizing a diagnostic angiogram followed by a multidisciplinary (vascular surgery, interventional cardiology) discussion prior to either selection of a treatment modality or determination of qualification for the study. We discuss the benefit of our newly adopted methodology in the care of the CLI patient.
All CLI patients from December 2014 to January 2016 presenting to Keck University Hospital of USC and LAC+USC Medical Center were evaluated. After non-invasive testing, patients underwent diagnostic angiography only. Discussion by a multidisciplinary team addressed proposed surgical and interventional revascularization strategies, optimization of co-morbidities, and organization of social support system with arrangements made for optimal follow up. Recommendations of the multidisciplinary committee were expeditiously communicated to the patient and family who were then allowed time for consideration. Patients agreeing to study participation were then randomized in accordance with the BEST trial specifications.
Thirty-two CLI patients were evaluated during the study period. Four had known reasons for ineligibility, and 28 were managed with our two-step process. After diagnostic angiogram and/or discussion by the multidisciplinary team, 26 patients agreed to participate and were randomized into the trial. The provision of information and time allotted for patients to determine participation in the study allowed for an optimal consent process with 93% enrollment of eligible CLI patients.
A two-step process which proved ideal for study enrollment, has the advantages of assuring safe and seamless approach to management of the CLI patient. The two-step methodology allows an orderly selection of well informed and physically and socially optimized patients, ready for the complex treatment strategies of limb salvage both within or outside the parameters of a randomized trial.