Major adverse limb events and major adverse cardiac events after contemporary lower extremity bypass and infrainguinal endovascular intervention in patients with claudication

Abstract

Objectives: Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) at 30 days provide standardized metrics for comparison and have been adopted by the Society for Vascular Surgery’s Objective Performance Goals for critical limb ischemia. However, MALE and MACE have not been widely adopted within the claudication population, and the comparative outcomes after lower extremity bypass (LEB) and infrainguinal endovascular intervention (IEI) remain unclear. The purpose of this study was to compare MALE and MACE after LEB and IEI in a contemporary national cohort and to determine predictors of MALE and MACE after revascularization for claudication. Methods: A national dataset of LEB and IEI performed for claudication was obtained using National Surgical Quality Improvement Program vascular-targeted participant use files from 2011-2014. Patients were stratified by LEB versus IEI and compared by appropriate univariate analysis. The primary outcomes were MALE (defined as untreated loss of patency, reintervention on the index arterial segment, or amputation of the index limb) and MACE (defined as stroke, myocardial infarction or death). Multivariable logistic regression was used to identify predictors of MALE and MACE. Results: A total of 3,925 infrainguinal revascularization procedures (2155 LEB and 1770 IEI) were performed for claudication. There was no difference in 30-day MALE between LEB and IEI (4.0% vs. 3.2%, P=.17). On multivariable logistic regression, predictors of 30-day MALE included tibial revascularization (OR 2.2, P<.0001) and prior LEB on the same arterial segment (OR 1.8, P=.004). LEB had significantly higher 30-day MACE (2.0% vs. 1.0%, P=.01) but similar mortality (0.5% vs. 0.4%, P=.6). Predictors of MACE included LEB vs IEI (OR 2.1, P=.01), chronic obstructive pulmonary disease (OR=2.2, P=.01), dialysis dependence (OR=4.4, P=.003) and diabetes (OR=1.9, P=.02). Conclusions: In this large national cohort, LEB and IEI for claudication are associated with similar 30-day MALE. Tibial revascularization and revascularization after prior failed bypass predict MALE in claudicants and should therefore be undertaken with caution. LEB was associated with higher 30-day MACE but comparable 30-day mortality compared to IEI. Patients with ESRD, COPD, and diabetes are high risk for MACE. The risk of 30-day MACE after LEB should be weighed against the longer-term outcomes of LEB vs IEI and conservative management, particularly in these higher risk patients. This analysis helps define contemporary 30-day outcomes after infrainguinal revascularization performed for claudication and serves as a baseline to which the short term outcomes of future treatments can be compared.

The Impact of Lower Extremity Skeletal Muscle Atrophy and Myosteatosis on Revascularization Outcomes in Patients with Peripheral Arterial Disease

“…The third model controlled for patientrelated and disease-related factors (i.e., type of intervention and Fontaine class) [19,20], and the fourth model controlled for patient-, disease-, and comorbidities-related factors (i.e., hypertension, hypercholesterolemia, coronary artery disease, hemodialysis, and ischemic stroke) [19,21]. For the amputation regression models, sex, chronic obstructive pulmonary disease (COPD), and type 2 diabetes were added [19,22,23].…”

Urinary Cystatin C Has Prognostic Value in Peripheral Artery Disease

“…The primary endpoint was major adverse limb events (MALEs), defined as the requirement for vascular intervention (open or endovascular revascularization) or major amputation (above the level of the ankle) [ 27 ]. The secondary endpoint was worsening PAD status, defined as a change in ABI ≥ 0.15 from baseline, which has been demonstrated to be clinically significant [ 28 , 29 , 30 ].…”

Protocol for a prospective observational diagnostic study: intraoperative simultaneous limb pressure monitoring (INSTANT) study

“…The primary outcome of this study will be defined as MALE. The expected 1-year event rate of MALE is higher in subjects with critical limb ischaemia (20.5%7 vs subjects with claudication 3.2%) 20. Based on a recent 10-year audit of endovascular procedures performed at the investigational centre (The Ottawa Hospital, Civic Campus) the expected proportion of eligible subjects with critical limb ischaemia (vs claudication) is 0.625.…”