VESS Clinical ResearchApplicability of the Society for Vascular Surgery's Objective Performance Goals for Critical Limb Ischemia to Current Practice of Lower-Extremity Bypass
Introduction
Critical limb ischemia (CLI) is estimated to affect 500 to 1,000 individuals per 1 million in the United States per year.1 Most of these patients receive some attempt at limb salvage be it endovascular or open surgery. Over the last 20 years in many centers, the paradigm for treating CLI has shifted from one favoring open surgical lower-extremity bypass (LEB) to an endovascular first approach. Although there is no direct work examining this ideological shift, a study performed examining all Medicare claims from 1996 to 2006 demonstrated that endovascular approaches for lower-extremity peripheral artery disease (PAD) increased 3.3 times over that decade, whereas the incidence of open surgical bypass procedures decreased by 42%, clearly demonstrating the increasing utilization of endovascular procedures for PAD.2 Despite this fact, there have been few randomized, controlled trials comparing endovascular interventions and open bypass procedures.3 Given this lack of Level I evidence and in an effort to provide a benchmark of outcomes for lower-extremity revascularization procedures against which investigators could compare future endovascular therapies, the Society for Vascular Surgery (SVS) developed a set of objective performance goals (OPGs) for CLI in 2009.4 These OPG were derived from data pooled from the open surgical bypass arms of 3 randomized controlled trials (RCTs) evaluating therapies for CLI including the Project of Ex Vivo Vein Graft Engineering Via Transfection III trial,5 the Circulase II trial,6 and the Bypass versus Angioplasty in Severe Ischemia of the Leg trial.3 Although these 3 RCTs included a variety of patients, the cohort used to develop the SVS OPG excluded all patients with end-stage renal disease (ESRD) and prosthetic conduit. These exclusions raise concerns about the generalizability of the SVS OPG to contemporary vascular surgical practice.
Although the SVS OPG were initially developed as a research tool to facilitate the evaluation of new endovascular therapies, some have suggested that they could be used as a metric for LEB outcomes. However, as many surgeons have adopted an endovascular first approach to the treatment of CLI, it is unlikely that the patients undergoing LEB in contemporary practice are similar to the cohort used to develop the SVS OPG. At this time, because patients who undergo LEB at our institution are usually those with limited or no viable endovascular option, we surmised that they were likely a group of patients with worse PAD and increased frequency of comorbid diseases (including ESRD and coronary artery disease [CAD]). Because of this hypothesis, we worried that these patients were not comparable to the cohort used by the SVS to create the OPG. Therefore, the aims of this study were threefold. First, to evaluate a contemporary population of patients undergoing LEB in the endovascular era at a tertiary care facility. Second, to determine what proportion of these patients would be SVS OPG eligible. And third, to delineate the outcomes of the patients who were SVS OPG eligible, and those who were not OPG eligible (non-OPG group) and assess whether these patients could realistically achieve the SVS OPG benchmarks.
Section snippets
Patients
This was a retrospective analysis of all patients who underwent infrainguinal LEB from January 2010 to December 2013 at a single institution. Data were obtained from a prospectively collected database, and further information was obtained from the electronic medical record. A total of 127 patients had 139 operations. Only the initial bypass procedure performed during the study period was included: all additional procedures (redo procedure on the ipsilateral limb or additional procedure on the
Patient Cohort
Eighty-nine individual patients underwent LEB for CLI during 2010–2013. Ten patients (11.2%) had ESRD with 9 requiring hemodialysis and 1 with a functioning renal transplant. Thirty-six patients required a prosthetic conduit (40.4%). These 2 patient groups were combined to form the non-OPG group and accounted for 46 patients or 51.7% of the total cohort. All other patients were considered OPG eligible and numbered 43 (48.3%). Within the OPG group, 8 patients (18.6% of the OPG group) were
Discussion
Patients in the non-OPG cohort failed to achieve any of the SVS OPG benchmarks in 30-day safety or 1-year efficacy. Even our OPG eligible group failed to make many of the SVS OPG. In fact, the only group who consistently met the SVS standards was the OPG low-risk group. With 51.7% of the total cohort not OPG eligible and only 19% of the total cohort OPG low risk, the SVS OPG are perhaps not suited to assess outcomes in patient cohorts of similar composition.
As the focus on surgical care shifts
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Cited by (8)
Endovascular Therapy in an “All-Comers” Risk Group for Chronic Limb-Threatening Ischemia Demonstrates Safety and Efficacy When Compared with the Established Performance Criteria Proposed by the Society for Vascular Surgery
2020, Annals of Vascular SurgeryCitation Excerpt :The group as a whole met the established goal, despite including the unmatched OPGR group. Of note, patients with high-risk comorbidities met and surpassed the short-term MALE and AMP safety endpoints, even when compared with open surgical procedures for CLTI.18,19 However, owing to the small sample size we would advise caution when interpreting these results.
Objective Performance Goals for Surgical Treatment of Critical Limb Ischemia
2019, Annals of Vascular SurgeryCitation Excerpt :Although this adjustment was made for the characteristics of endovascular therapy, we compared our results to the existing SVS OPGs as our patients were not treated under controlled study conditions compared to those in the control group. Although the efficacy and safety of OPG values could be evaluated under an everyday vascular surgery practice for a group of patients with the same specifications (venous graft, no ESRD) for lower extremity bypass, there was doubt if a contemporary collective of patients could achieve the SVS OPG values.16,17 In 2 studies with a single-center cohort and with a collective from the Vascular Study Group of New England (VSGNE), Saraidaridis et al. compared patients with ESRD or any type of prosthetic conduit (non-OPG cohort) with patients fulfilling the OPG criteria (OPG cohort).
Lower extremity bypass for critical limb ischemia decreases major adverse limb events with equivalent cardiac risk compared with endovascular intervention
2017, Journal of Vascular SurgeryCitation Excerpt :Furthermore, additional research is needed on patients undergoing LEB with alternative/prosthetic conduit because they were excluded from recent Society for Vascular Surgery OPGs, and there are data to support that they have worse long-term outcomes.1,9 Many of the independent predictors of 30-day MALEs and amputation in the multivariate analyses were nonmodifiable patient-level risk factors, including end-stage renal disease, systemic inflammatory response syndrome/sepsis, weight loss, American Society of Anesthesiologists class, and race, which have been previously demonstrated.9,11,14,19 However, we demonstrate that preoperative statin (OR, 0.8; P = .04) and antiplatelet (OR, 0.8; P = .049) therapy both independently reduce the risk of 30-day MALEs.
Outcomes of Multidisciplinary and Evidence-Based Management of Chronic Limb Threatening Ischemia Patients: The Impacts of Protocol-Based Care Processes
2023, Journal of the Medical Association of ThailandSurgical Bypass of Femoral-Poplieal Arerial Disease: A Mea-analysis of Randomized and Prospecive Trials
2022, Journal of Critical Limb Ischemia
Presented as a plenary at the Vascular and Endovascular Surgery Winter Meeting, Vail, CO, January 31, 2015.