Objective Performance Goals Research Articles

Objective performance goals after endovascular intervention for critical limb ischemia

During the last decade, primary endoluminal therapy for critical limb ischemia (CLI), assessed as rest pain and tissue loss of the lower extremity, has significantly increased. Reporting of patient-centered outcomes using the new Society for Vascular Surgery objective performance goals (OPGs) has been limited. This study examined the OPGs for infrainguinal endovascular management of CLI. A prospective database of patients undergoing endovascular treatment of the lower extremity for CLI between 2000 and 2011 was queried. Evaluated were clinical efficacy (absence of recurrent symptoms, maintenance of ambulation and absence of major amputation), amputation-free survival (survival without major amputation), and freedom from major adverse limb events (MALEs; above-ankle amputation of the index limb or major reintervention - new bypass graft, jump/interposition graft revision). A total of 728 patients (60% male; age, 68 ± 14 years) underwent lower extremity interventions for CLI (66% tissue loss); of these, 39% had superficial femoral artery and tibial interventions. Diabetes mellitus was present in 71%, hyperlipidemia in 64%, and chronic renal insufficiency in 37%. Technical success was 96%. The overall rate at 30 days of major adverse cardiovascular events (MACEs) was 3% and MALEs was 12%. At 5 years, clinical efficacy was (mean ± standard error of the mean) 42% ± 5%, amputation-free survival was 41% ± 7%, and freedom from MALEs was 51% ± 4%. Clinical efficacy was significantly different in those presenting with rest pain and tissue loss and in the anatomic high-risk group compared with the clinical high-risk group, and both were worse compared with the group without clinical or high-risk criteria. Endoluminal therapy for CLI is associated with early low MACE rates but high MALE rates. When the key outcome of amputation free survival is considered, predictors of a better outcome were absence of current smoking, a lower modified Edifoligide for the Prevention of Infrainguinal Vein Graft Failure (PREVENT III) amputation risk score, better preoperative ambulation status, lower MACEs, and discharge disposition to home. The presence of tissue loss and anatomic risk factors negatively affect outcomes. Longer-term outcomes after endovascular intervention for CLI remain relatively poor, with <40% success in objective performance outcomes at 5 years.

2-Year Outcomes After Iliofemoral Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis Deemed Extreme Risk for Surgery

BackgroundWe reported favorable 1-year outcomes in patients unsuitable for surgery who underwent self-expanding transcatheter aortic valve replacement (TAVR) compared with an objective performance goal. Longer-term outcomes in these patients are not known. ObjectivesThis study sought to evaluate the 2-year safety and efficacy in patients with severe aortic stenosis (AS) at extreme risk of surgery treated with self-expanding TAVR. MethodsWe performed a prospective, multicenter, controlled, nonrandomized investigation of self-expanding TAVR in patients with severe AS and prohibitive surgical risk. We report the 2-year clinical outcomes in these patients. ResultsA total of 489 extreme-risk patients were treated transfemorally with a self-expanding aortic bioprosthesis at 41 centers. The rate of all-cause mortality or major stroke was 38.0% at 2 years (all-cause mortality, 36.5%; major stroke, 5.1%). The rates of all-cause mortality, cardiovascular mortality, and major stroke were 36.6%, 26.2%, and 5.1%, respectively, at 2 years. Between 1 and 2 years, the incremental all-cause mortality, cardiovascular mortality, and major stroke rates were 12.3%, 7.9%, and 0.8%, respectively. Multivariable predictors of all-cause mortality at 2 years included the presence of coronary artery disease and admission from an assisted living center. A Society of Thoracic Surgeons score >15% was also predictive of 2-year all-cause mortality. At 2 years, 94% of patients had New York Heart Association functional class I or II symptoms. The frequency of moderate or severe paravalvular regurgitation (4.3% at 1 year; 4.4% at 2 years) was unchanged between the first and second year. ConclusionsPatients with severe AS at extreme surgical risk treated with self-expanding TAVR continued to show good clinical outcomes and hemodynamic valve performance at 2 years. The presence of comorbid conditions rather than valve performance affected 2-year outcomes in these patients. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)

Outcomes of Isolated Tibial Endovascular Interventions for Tissue Loss in CLI Patients on Hemodialysis

Purpose: To compare the objective performance goals (OPGs) and patient-centered outcomes of isolated tibial interventions in patients with tissue loss who were on hemodialysis (HD) to patients with tissue loss who were not on HD. Methods: Interrogation of a prospectively maintained database identified 242 critical limb ischemia (CLI) patients who underwent isolated tibial interventions for tissue loss in a single limb between 2007 and 2012. The 78 patients (mean age 66±12 years; 44 men) on HD were compared with 164 patients (mean age 50±13 years; 82 men) who were not on HD. There was an equal distribution of the tibial vessels treated; 152 (63%) patients had more than one treated tibial vessel. Patient-centered outcomes of clinical efficacy (absence of recurrent symptoms, maintenance of ambulation, and no major amputation), amputation-free survival (AFS), and freedom from major adverse limb events (MALE) were evaluated. The Society for Vascular Surgery OPGs were defined at 30 days and 1 year. Results: The 30-day major adverse cardiac events was significantly higher (p=0.004) in the HD group (5, 5%) compared with the no-HD group (0%), but both remained under the stated OPG of ≤10%. The 30-day MALE rates were significantly higher than the stated ≤9% OPG at 13% and 18% for the no-HD and HD groups, respectively. At 1 year, the rates for AFS, freedom from MALE, limb salvage, and survival did not achieve the stated Society for Vascular Surgery OPGs in the HD group. Clinical efficacy was 61% and 25% at 3 years for the no-HD and HD groups, respectively (p<0.01). Overall, AFS was 54% and 22% and freedom from MALE was 56% and 27% at 3 years for the no-HD and HD groups, respectively (both p<0.01). Conclusion: Tibial intervention for tissue loss in patients on HD is a valid treatment option but is associated with a high MALE rate. Three-year outcomes remain relatively poor, with <25% success in terms of clinical efficacy and AFS.

Outcomes of cold-stored venous allograft for below-knee bypasses in patients with critical limb ischemia

Critical limb ischemia (CLI), the most advanced form of peripheral arterial disease, is associated with strikingly high morbidity and mortality rates. Autogenous single-segment great saphenous vein (GSV) remains the optimal conduit for infrainguinal revascularization. Unfortunately, GSV is unavailable in up to 20% of patients. There is no consensus about the alternative graft that should be used for infragenicular bypass grafting when the GSV is unavailable. Currently, there are no outcome data for cold-stored venous allograft use in regard to recent safety and efficacy objective performance goals described by the Society for Vascular Surgery. This is a retrospective analysis of 118 infragenicular revascularizations performed for CLI with cold-stored venous allografts obtained from varicose vein stripping surgery in a single institution from November 2002 to August 2013. Mean age (± standard deviation) was 75 ± 12 years (male, 76%; diabetes, 73%; dialysis, 16%), and 38% (n = 45) had a history of failed ipsilateral revascularization. None had suitable autogenous conduit for even composite vein bypass. The distal anastomosis was performed to an infrapopliteal artery in 85 cases (72%). At 30 days, perioperative death rate was 6.8%, major adverse cardiovascular event rate was 7.6%, and major adverse limb event rate was 11.9%. Mean follow-up was 34 ± 29 months (range, 1-113 months). At 1 year, freedom from major adverse limb event or perioperative death, limb salvage, survival, amputation-free survival, and secondary patency rates were, respectively, 64.9%, 82.5%, 85.4%, 73.3%, and 58.3%. Ejection fraction <45% and dialysis were the most significant factors predicting failure of revascularization. Cold-stored venous allografts may be used for performing infragenicular revascularization for CLI with acceptable safety and efficacy results despite poor long-term patency. Their level of performance remains inferior to autologous vein sources but seems comparable to alternative allografts or prosthetic conduit. Their availability is a major advantage compared with other biologic alternative sources.

The Society for Vascular Surgery's objective performance goals for lower extremity revascularization are not generalizable to many open surgical bypass patients encountered in contemporary surgical practice

In 2009, the Society for Vascular Surgery (SVS) established objective performance goals (OPG) for lower extremity bypass (LEB) in patients with critical limb ischemia (CLI) based on pooled data from previously performed prospective studies in an effort to provide a benchmark and historical control for future trials. However, patients with a prosthetic conduit and end-stage renal disease were excluded from this cohort. In contemporary practice, many patients do not meet the criteria for SVS OPG inclusion, making generalization of the SVS OPG difficult. The goal of this study was to establish safety and efficacy measures for patients who were excluded from the original SVS OPG analysis. All patients who underwent LEB for CLI in the Vascular Study Group of New England (VSGNE) from 2003 to 2013 were identified. Patients were stratified into OPG-eligible and non-OPG-eligible cohorts. Outcomes included 30-day major adverse limb events, 30-day major adverse cardiovascular events, 1-year survival, and 1-year freedom from amputation. The SVS OPG methodology was used to create new performance goals for the non-OPG-eligible patients. We identified 3609 patients: 2360 OPG (65%) vs 1249 non-OPG (35%), and overall results were stratified as a function of OPG status. The 30-day major adverse limb event rate was 5.0% (5.5% non-OPG vs 4.4% OPG; P = .34), and the 30-day major adverse cardiovascular event rate was 7.3% (9.2% non-OPG vs 6.2% OPG; P = .001). At 1 year, survival was 84% (75.9% non-OPG vs 88.3% OPG; P < .001), and freedom from amputation was 86.9% (80.9% non-OPG vs 90.1% OPG; P < .001). The SVS OPG were attainable in New England for the population of patients who would have met SVS OPG study cohort inclusion criteria. However, 35% of the patients who underwent LEB for CLI in the last 10 years fell outside of these criteria by having end-stage renal disease or requiring a prosthetic conduit. We therefore suggest new benchmarks for these high-risk populations.

Clinical Efficacy of Infrapopliteal Endovascular Procedures for Hemodialysis Patients with Critical Limb Ischemia

To investigate 5-year clinical outcomes after infrapopliteal endovascular therapy (EVT) for critical limb ischemia (CLI) patients on or not on hemodialysis (HD), and compare the clinical efficacy of EVT between the 2 groups. The subjects were 1091 CLI patients (1310 limbs) who underwent EVT for isolated infrapopliteal lesions from 2004 to 2012, and were classified into 2 groups for comparative study: the patients on HD group (670 patients, 830 limbs) and not on HD group (421 patients, 480 limbs). The HD group had a significantly lower rate of freedom from major adverse limb events or perioperative death (HD 78.4% vs. non-HD 86.0% at 1 year, HD 70.3% vs. non-HD 82.4% at 5 years, P = 0.01), or amputation-free survival (AFS) rate (HD 65.7% vs. non-HD 78.7% at 1 year, HD 34.4% vs. non-HD 59.8% at 5 years, P < 0.01) after EVT compared with the non-HD group. Independent predictors of AFS in HD patients were nonambulatory, diabetes mellitus, albumin <3.0 g/dL, ejection fraction ≤0.48, and no patent pedal arch arteries before EVT. AFS at 1 year was 81% in patients with 0 or 1 predictor, surpassing the suggested AFS objective performance goal (OPG) end points of 68%, but AFS in patients with 2 or more predictors failed to reach the OPG. In comparison with non-HD patients, the clinical efficacy of infrapopliteal EVT for HD patients was poor. Preoperative risk stratification based on AFS predictors can be used as an index for predicting the prognosis.

31. Applicability of the Society for Vascular Surgery's Objective Performance Goals for Critical Limb Ischemia To Current Practice of Lower Extremity Bypass

31. Applicability of the Society for Vascular Surgery's Objective Performance Goals for Critical Limb Ischemia To Current Practice of Lower Extremity Bypass

The Society for Vascular Surgery lower extremity threatened limb classification system based on Wound, Ischemia, and foot Infection (WIfI) correlates with risk of major amputation and time to wound healing

The purpose of this study was to evaluate whether the new Society for Vascular Surgery (SVS) Wound, Ischemia, and foot Infection (WIfI) classification system correlates with important clinical outcomes for limb salvage and wound healing. A total of 201 consecutive patients with threatened limbs treated from 2010 to 2011 in an academic medical center were analyzed. These patients were stratified into clinical stages 1 to 4 on the basis of the SVS WIfI classification. The SVS objective performance goals of major amputation, 1-year amputation-free survival (AFS) rate, and wound healing time (WHT) according to WIfI clinical stages were compared. The mean age was 58 years (79% male, 93% with diabetes). Forty-two patients required major amputation (21%); 159 (78%) had limb salvage. The amputation group had a significantly higher prevalence of advanced stage 4 patients (P < .001), whereas the limb salvage group presented predominantly as stages 1 to 3. Patients in clinical stages 3 and 4 had a significantly higher incidence of amputation (P < .001), decreased AFS (P < .001), and delayed WHT (P < .002) compared with those in stages 1 and 2. Among patients presenting with stage 3, primarily as a result of wound and ischemia grades, revascularization resulted in accelerated WHT (P = .008). These data support the underlying concept of the SVS WIfI, that an appropriate classification system correlates with important clinical outcomes for limb salvage and wound healing. As the clinical stage progresses, the risk of major amputation increases, 1-year AFS declines, and WHT is prolonged. We further demonstrated benefit of revascularization to improve WHT in selected patients, especially those in stage 3. Future efforts are warranted to incorporate the SVS WIfI classification into clinical decision-making algorithms in conjunction with a comorbidity index and anatomic classification.

Abstract 20579: Chronic Kidney Disease is Associated With Increased Mortality and Major Adverse Cardiovascular Events in Patients With Peripheral Arterial Disease

Introduction: Chronic kidney disease (CKD) is common in patients with peripheral arterial disease (PAD), but patients with severe CKD have been excluded from many trials and no objective performance goals exist for patients with PAD and CKD. We sought to analyze the association between severity of CKD and cardiovascular and limb-related outcomes among patients with PAD. Methods: We reviewed records of all patients at our institution who underwent lower extremity angiography between 2006 and 2013. We analyzed outcomes including mortality, major adverse cardiovascular event (MACE) rate, and major adverse limb event (MALE) rate according to clinical stage of CKD, determined by calculating each patient’s glomerular filtration rate using the Cockcroft-Gault equation. We used Cox proportional hazard modeling to account for covariates, along with Bonferroni correction for multiple comparisons. Results: Of 773 patients, 45% had CKD stage 3-5. The patients had a median age of 67, were 58% male, 51% diabetic, and 57% presented with critical limb ischemia (CLI). During a median follow-up time of 3.2 years, patients with higher stages of CKD had an increased rate of death (Figure 1, p&lt;0.001). CKD stages 4 and 5 were significant predictors of mortality in a multivariate model (HR 3.2 and 2.4 vs. CKD 1, P&lt;0.001 and P&lt;0.01, respectively). An analysis of MACE by CKD stage demonstrated similar results (CKD 4 HR 2.2, p&lt;0.01; CKD 5 HR 2.0, p&lt;0.01). CKD stage also predicted MALE in a univariate analysis (p&lt;0.01), driven by increased limb events among patients with CKD stage 5 (p&lt;0.01). However, CKD stage did not demonstrate a significantly increased hazard of MALE in a multivariate Cox model. Conclusions: Patients with PAD who also have CKD have increased rates of adverse outcomes. This relationship seems to be more robust for major cardiovascular events and overall mortality than for major limb events. Future studies should investigate how management of PAD should differ for patients with CKD.

Using Vascular Quality Initiative as a Platform for Organizing Multicenter, Prospective, Randomized Clinical Trials: OVERPAR Trial

We describe the organization of a prospective, randomized, multicenter trial comparing the effectiveness of open popliteal artery aneurysm repair (OPAR) and endovascular popliteal artery aneurysm repair (EPAR) of asymptomatic popliteal artery aneurysms (PAAs) as an example for how to use the Vascular Quality Initiative (VQI) framework. Given that many centers participate in the VQI, this model can be used to perform multicenters' prospective trials on very modest budget. VQI prospectively collects data on many vascular procedures. These data include many important perioperative, intraoperative, and postoperative details regarding both patients and their procedures. We describe a study where minimal changes to the collected data by participating centers can provide level-1 evidence regarding a significant clinical question. Data will be collected using modified VQI forms within the existing VQI data reporting structure. We plan to enroll 148 patients with asymptomatic PAAs into the open and endovascular surgery cohorts. Patients from participating VQI centers will be randomized 1:1 to either OPAR or EPAR and will be followed for an average of 2.5 years. Our primary hypothesis is that major adverse limb event-free survival is lower in the EPAR cohort and that EPAR is associated with more secondary interventions, improved quality of life, and decreased length of stay. The budget for this trial is fixed at $10,000/year for the course of the study, and the trial is judged to be feasible because of the functionality of the VQI platform. Using the existing VQI infrastructure, Open versus Endovascular Repair of Popliteal Artery Aneurysm will provide level 1 data for PAA treatment on a modest budget. The proposed trial has an adequately powered comparative design that will use objective performance goals to describe limb-related morbidity and procedural reintervention rates.

PS160. Applicability of the Society for Vascular Surgery's Objective Performance Goals for Critical Limb Ischemia to Current Practice of Lower Extremity Bypass

Background: In 2009, the Society for Vascular Surgery (SVS) established objective performance goals (OPGs) for critical limb ischemia (CLI) based on data from previous, randomized, controlled trials of lower-extremity bypass (LEB). These OPG sought to establish a benchmark of outcomes to which one could compare future endovascular therapy. However, the cohort used to develop the OPG excluded all patients who required prosthetic conduit and those with end-stage renal disease (ESRD), possibly limiting the generalizability of these results and the subsequent guidelines. The goal of this study was to determine if the SVS OPG are applicable to the current population of patients undergoing LEB. Methods: All patients who underwent infrainguinal LEB for CLI from January 2010 to December 2013 were identified in a prospectively maintained database. Patients were stratified into OPG eligible and ineligible (non-OPG) groups based on their demographic and operative characteristics. OPG eligible patients were further stratified into high risk and average risk. Outcomes included 30-day major adverse limb events (MALEs), 30-day major adverse cardiovascular events (MACE), 1-year survival, and 1-year freedom from amputation. Results: A total of 89 individual patients were identified. Only 43 (48%) patients met OPG inclusion criteria and 46 (52%) were not OPG eligible (non-OPG). The 30-day MALE was 8.7% (13.0% non-OPG vs. 7.0% OPG, P 1⁄4 0.34). The 30-day MACE was 11.2% (13.0% non-OPG vs. 9.3% OPG, P 1⁄4 0.58). One-year survival was 80.3% ± 4.5% (71.2% non-OPG vs. 90.0% OPG, P 1⁄4 0.21). One-year freedom from amputation was 71.7% ± 5.5% (58.8% non-OPG vs. 84.0% OPG, P 1⁄4 0.03). Conclusions: The SVS OPG for LEB are likely not generalizable to current practice as 51% of patients would have been excluded from the SVS cohort because of ESRD and prosthetic conduit. Most SVS OPG (30-day MALE, 1-year survival, and 1-year limb salvage) were attainable in patients who met SVS OPG inclusion criteria; but for the patients who are not OPG eligible, new benchmarks are needed.

Transcatheter Aortic Valve Replacement Using a Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis at Extreme Risk for Surgery

This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery. Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy. We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG). A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis). TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Safety and Efficacy Outcomes of Infrapopliteal Endovascular Procedures Performed in Patients With Critical Limb Ischemia According to the Society for Vascular Surgery Objective Performance Goals

Objective performance goals (OPGs) are a set of standardized end points generated from well documented historical controls against which new therapeutic procedures may be compared in single-arm studies. Recently, the Society for Vascular Surgery suggested a set of OPGs designed from vein bypass controls that could be used to evaluate the safety and efficacy of endovascular devices applied to critical limb ischemia through a noninferiority analysis. Our aim is to analyze the results of infrapopliteal endovascular procedures performed in patients with critical limb ischemia according to these OPG end points. This is a retrospective study of 121 infrapopliteal endovascular procedures. The tibial intervention was combined with a femoropopliteal angioplasty in 70 procedures. Major adverse cardiovascular events (MACEs), major adverse limb events (MALEs), and major amputations at 30 days were recorded as safety outcomes. Freedom from any MALE or perioperative death (Freedom from MALE + POD) and amputation-free survival were calculated as primary efficacy end points at both 12 months and at 8 years. The 95% confidence intervals (CIs) of all the end points were calculated to perform a noninferiority comparison using OPGs as the reference. The incidence of MACEs, MALEs, and amputation at 30 days were 5% (95% CI: 2-10% [OPG-MACE <10%]), 2.5% (95% CI: 0.5-7% [OPG-MALE <9%]), and 1.7% (95% CI: 0.2-6% [OPG-major amputation <4%]), respectively. We recorded a freedom from MALE + POD of 76% (95% CI: 67-83% [OPG-MALE + POD >67%]) and an amputation-free survival of 78% (95% CI: 69-85% [OPG-amputation-free survival >68%]) at 12 months. Freedom from MALE + POD and amputation-free survival at 8 years decreased to 60% (95% CI: 49-69%) and to 26% (95% CI: 11-44%), respectively. Infrapopliteal endovascular procedures performed in everyday vascular surgery practice could meet the main OPG end points proposed for catheter-based treatment of critical limb ischemia.

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Impact of severe chronic kidney disease on outcomes of infrainguinal peripheral arterial intervention

Patients with severe chronic kidney disease (CKD) and peripheral vascular disease are at increased risk of major adverse limb events (MALEs) and death; however, patients with end-stage renal disease have been excluded in current objective performance goals. We evaluated the effect of severe (class 4 and 5) CKD on outcomes after infrainguinal endovascular arterial interventions. All primary peripheral vascular interventions (PVIs) performed at a single institution (January 2002 through December 2009) were included. End points were defined by Society for Vascular Surgery objective performance goals for critical limb ischemia (CLI), which include all-cause mortality, reintervention, and composite end points of death or amputation and MALEs (reintervention or amputation). Univariate and multivariable analysis was used to examine the effect of severe CKD on study end points. A total of 879 PVIs were performed, with severe CKD in 125 (14%). Severe CKD patients were significantly (P < .05) more likely to have diabetes (64% vs 46%), CLI (72% vs 11%), and need a multilevel PVI (34% vs 19%) or tibial intervention (35% vs 20%) compared with the remainder of the cohort. Distribution of TransAtlantic Inter-Society Consensus C and D lesions were similar (19% severe CKD vs 15%; P = .2). Severe CKD predicted perioperative (30-day) reintervention (odds ratio [OR], 2.3; 95% confidence interval [CI], 1.5-4; P = .05), amputation or death (OR, 3.1; 95% CI, 1.1-9; P = .04), and MALEs (OR, 2.8; 95% CI, 1.3-6.1; P = .04), which was independent of CLI in multivariable regression analysis. On Kaplan-Meier analysis, severe CKD was significantly (log-rank P < .05) associated with death (31% ± 4% vs 7% ± 1%), amputation (14% ± 3% vs 3% ± 1%), and MALEs (40% ± 5% vs 26% ± 2%) at 1 year. Freedom from reintervention was similar at 1 year (70% ± 5% severe CKD vs 75% ± 2%; P = .23). Risk-adjusted (age, CLI, diabetes, coronary artery disease) Cox proportional hazards regression showed that severe CKD increased the risk of late mortality (hazard ratio [HR], 2.4; 95% CI, 1.8-3.2; P < .01), amputation (HR, 2.1; 95% CI, 1.1-3.9; P = .02), and death or amputation (HR, 1.8; 95% CI, 1.3-2.4; P = .04), without increasing the risk of late reinterventions or MALEs. CKD independently predicts early and late adverse events after a PVI, in particular, excessive mortality. CKD should figure prominently in clinical decision making for patients with peripheral vascular disease.

Impact of Chronic Kidney Disease on the Effectiveness of Peripheral Endovascular Interventions

Patients with severe chronic kidney disease (CKD) were excluded from the Society for Vascular Surgery objective performance goals (OPG) derivation cohort due to established poor surgical outcomes in this group. We examine the impact of diminished creatinine clearance (CrCl) on the long-term outcomes of peripheral endovascular interventions. Retrospective review of prospectively collected institutional outcomes data (2006-2012) included calculation of CrCl and stratification by CKD class. Outcomes among those with mild (class 1, 2) moderate (class 3), and severe (class 4, 5) CKD were compared using Society for Vascular Surgery OPG outcome metrics. Multivariate models were developed to identify risk factors for poor outcome and specifically assess the impact of CKD. 454 patients underwent treatment of 523 limbs for claudication (56%), rest pain (12%), or tissue loss (32%). Over 77% of patients had abnormally low CrCl, with moderate CKD noted in 37% and severe CKD in 13%. Increasing CKD class was associated with worse outcomes across all outcome metrics by crude survival analysis. Following adjustment for all other risk factors, the impact of severe CKD was independently associated with reduced overall survival (HR, 2.69; 95% CI, 1.70-4.26; P < .001), amputation-free survival (HR, 3.15; 95% CI, 2.04-3.86; P < .001), limb salvage (HR, 4.35; 95% CI, 1.50-12.33; P = .006), major adverse limb events (HR, 2.07; 95% CI, 1.02-4.20; P = .04), freedom from reintervention and amputation (HR, 1.82; 95% CI, 1.12-2.94; P = .015), and freedom from reintervention, amputation, and stenosis (HR, 1.58; 95% CI, 1.02-2.46; P = .041). Moderate and severe CKD are highly prevalent among patients with peripheral artery disease. While severe CKD adversely affects long-term outcomes after ET as well as surgical bypass, quantification of the impact of reduced CrCl on survival- and limb-based metrics may enhance risk adjustment for comparative effectiveness research and improve patient-centered clinical decision-making.

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PS106. The Society for Vascular Surgery's Objective Performance Goals: A Validation Study of Laser-Assisted Angioplasty: A Safe and Effective Technique for the Management of Critical Limb Ischemia

In 2009 the Society for Vascular Surgery (SVS) developed Objective Performance Goals (OPGs) to assess the safety and efficacy of endovascular treatments of critical limb ischemia (CLI). We evaluated Laser-assisted angioplasty (LAA), using the OPGs All patients that underwent LAA to treat CLI between January 2006 and May 2010 were analyzed. The 30 day safety endpoints of Major Adverse Cardiac Event (MACE) (i.e. Postoperative Death (POD), Myocardial Infarction (MI ) and Cerebrovascular Accident (CVA), Amputation rate and Major Adverse Limb Event (MALE) rate (i.e. thrombosis, thrombectomy, and bypass) were calculated. The efficacy endpoints were calculated using Kaplan-Meier life table analysis. These included MALE + POD, Amputation Free Survival (AFS), and any Re-intervention or above ankle Amputation and Stenosis /occlusion (RAS) calculated at one year. Subsequently, a comparison with the SVS OPGs was made using the student T test. : Laser assisted angioplasty was used to treat 82 limbs with CLI. The mean age was 72.8 years, with a mean follow up of 19 months. Tissue loss and gangrene were the most common indications, in 67 (81.2%) of the limbs. Safety endpoints were: mortality rate 2.6%, MACE rate 3.9%, amputation rate 2.4%, and MALE rate of 9.7%. Efficacy endpoints were MALE + POD 84.1%, Amputation Free Survival 84.1%, and RAS 39%.Our study cohort was compared to the SVS OPGs using the Student T test; MACE 3.9% vs. 5.1% (P = .72), 30 day amputation rate 2.4% vs. 1.3% (P = .43), MALE 9.7% vs. 4.6% (P = .06). One year outcomes: MALE+POD 84.1% vs. 76.9% (P = .14), AFS 84.1% vs. 76.5% (P = .14), RAS 39% vs. 46.5% (P = .21). No statistically significant difference was noted. Our study demonstrates that the OPGs are attainable in clinical practice. Moreover, LAA meets the safety and efficacy OPGs for endovascular treatment of CLI.

Extracorporeal Membrane Oxygenation for Bridge to Heart Transplantation Among Children in the United States

Background— Extracorporeal membrane oxygenation (ECMO) has served for &gt;2 decades as the standard of care for US children requiring mechanical support as a bridge to heart transplantation. Objective data on the safety and efficacy of ECMO for this indication are limited. We describe the outcomes of ECMO as a bridge to heart transplantation to serve as performance benchmarks for emerging miniaturized assist devices intended to replace ECMO. Methods and Results— Data from the Extracorporeal Life Support Organization Registry and the Organ Procurement Transplant Network database were merged to identify children supported with ECMO and listed for heart transplantation from 1994 to 2009. Independent predictors of wait-list and posttransplantation in-hospital mortality were identified. Objective performance goals for ECMO were developed. Of 773 children, the median age was 6 months (interquartile range, 1 to 44 months); 28% had cardiomyopathy; and in 38%, a bridge to transplantation was intended at ECMO initiation. Overall, 45% of subjects reached transplantation, although one third of those transplanted died before discharge; overall survival to hospital discharge was 47%. Wait-list mortality was independently associated with congenital heart disease, cardiopulmonary resuscitation before ECMO, and renal dysfunction. Posttransplantation mortality was associated with congenital heart disease, renal dysfunction, ECMO duration of &gt;14 days, and initial ECMO indication as a bridge to recovery. In the objective performance goal cohort (n=485), patients with cardiomyopathy had the highest survival to hospital discharge (63%), followed by patients with myocarditis (59%), 2-ventricle congenital heart disease (44%) and 1-ventricle congenital heart disease (33%). Conclusion— Although ECMO is effective for short-term circulatory support, it is not reliable for the long-term circulatory support necessary for children awaiting heart transplantation. Fewer than half of patients bridged with ECMO survive to hospital discharge. More effective modalities for chronic circulatory support in children are urgently needed.