One-Year Results of the LIBERTY 360 Study: Evaluation of Acute and Midterm Clinical Outcomes of Peripheral Endovascular Device Interventions

Purpose: To report the 1-year results of a multicenter study of peripheral artery disease (PAD) treatment with a variety of endovascular treatment strategies employed in routine practice. Materials and Methods: The LIBERTY trial ( ClinicalTrials.gov identifier NCT01855412) is a prospective, observational, core laboratory–assessed, multicenter study of endovascular device intervention in 1204 subjects (mean age 69.8±10.7 years; 770 men) stratified by Rutherford category (RC): claudicants (RC2,3; n=501) and critical limb ischemia (CLI) with no/minimal tissue loss (RC4,5; n=603) or significant tissue loss (RC6; n=100). Key outcomes included quality of life (QoL) measures (VascuQol and EuroQol) and freedom from major adverse events (MAE), defined as death (within 30 days), major amputation, and target vessel revascularization based on Kaplan-Meier analysis. Results: Successful revascularization was beneficial, with RC improvement noted across all groups. Thirty-day freedom from MAE estimates were high across all groups: 99.2% in RC2,3, 96.1% in RC4,5, and 90.8% in RC6. At 12 months, the freedom from MAE was 82.6% in RC2,3, 73.2% in RC4,5, and 59.3% in RC6 patients. Estimates for freedom from major amputation at 12 months were 99.3%, 96.0%, and 81.7%, respectively. QoL scores improved significantly across all domains in all groups with 12-month VascuQol total scores of 5.3, 5.0, and 4.8 for RC2,3, RC4,5, and RC6, respectively. Conclusion: The results indicate that peripheral endovascular intervention is a viable treatment option for RC2,3, RC4,5, and RC6 patients as evidenced by the high freedom from major amputation, as well as the improvement in QoL and the RC at 12 months. Furthermore, primary unplanned amputation is often not necessary in RC6.

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Three-Year Outcomes of Orbital Atherectomy for the Endovascular Treatment of Infrainguinal Claudication or Chronic Limb-Threatening Ischemia

Journal of Endovascular Therapy ◽

10.1177/1526602820935611 ◽

2020 ◽

Vol 27 (5) ◽

pp. 714-725 ◽

Cited By ~ 2

Author(s):

Stefanos Giannopoulos ◽

Eric A. Secemsky ◽

Jihad A. Mustapha ◽

George Adams ◽

Robert E. Beasley ◽

...

Keyword(s):

Cox Regression ◽

Major Amputation ◽

Peripheral Artery ◽

Target Vessel Revascularization ◽

Kaplan Meier ◽

Orbital Atherectomy ◽

The Mean ◽

Artery Disease ◽

Endovascular Devices

Purpose: To investigate the outcomes of orbital atherectomy (OA) for the treatment of patients with peripheral artery disease (PAD) manifesting as claudication or chronic limb-threatening ischemia (CLTI). Materials and Methods: The database from the LIBERTY study ( ClinicalTrials.gov identifier NCT01855412) was interrogated to identify 503 PAD patients treated with any commercially available endovascular devices and adjunctive OA for 617 femoropopliteal and/or infrapopliteal lesions. Cox regression analyses were employed to examine the association between baseline Rutherford category (RC) stratified as RC 2-3 (n=214), RC 4-5 (n=233), or RC 6 (n=56) and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE), and major amputation/death at up to 3 years of follow-up. The mean lesion lengths were 78.7±73.7, 131.4±119.0, and 95.2±83.9 mm, respectively, for the 3 groups. Results: After OA, balloon angioplasty was used in >98% of cases, with bailout stenting necessary in 2.0%, 2.8%, and 0% of the RC groups, respectively. A small proportion (10.8%) of patients developed angiographic complications, without differences based on presentation. During the 3-year follow-up, claudicants were at lower risk for MAE, death, and major amputation/death than patients with CLTI. The 3-year Kaplan-Meier survival estimates were 84.6% for the RC 2-3 group, 76.2% for the RC 4-5 group, and 63.7% for the RC 6 group. The 3-year freedom from major amputation was estimated as 100%, 95.3%, and 88.6%, respectively. Among CLTI patients only, the RC at baseline was correlated with the combined outcome of major amputation/death, whereas RC classification did not affect TVR, MAE, major amputation, or death rates. Conclusion: Peripheral artery angioplasty with adjunctive OA in patients with CLTI or claudication is safe and associated with low major amputation rates after 3 years of follow-up. These results demonstrate the utility of OA for patients across the spectrum of PAD.

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Non-compressible ABIs are associated with an increased risk of major amputation and major adverse cardiovascular events in patients with critical limb ischemia

Vascular Medicine ◽

10.1177/1358863x16689831 ◽

2017 ◽

Vol 22 (3) ◽

pp. 210-217 ◽

Cited By ~ 7

Author(s):

Gagan D Singh ◽

Ehrin J Armstrong ◽

Stephen W Waldo ◽

Bejan Alvandi ◽

Ellen Brinza ◽

...

Keyword(s):

Clinical Outcomes ◽

Critical Limb Ischemia ◽

Cardiovascular Events ◽

Limb Ischemia ◽

Major Amputation ◽

Tissue Loss ◽

Major Adverse Cardiovascular Events ◽

Increased Risk ◽

Artery Disease ◽

Stage Renal Disease

Ankle–brachial indices (ABIs) are important for the assessment of disease burden among patients with peripheral artery disease. Although low values have been associated with adverse clinical outcomes, the association between non-compressible ABI (ncABI) and clinical outcome has not been evaluated among patients with critical limb ischemia (CLI). The present study sought to compare the clinical characteristics, angiographic findings and clinical outcomes of those with compressible (cABI) and ncABI among patients with CLI. Consecutive patients undergoing endovascular evaluation for CLI between 2006 and 2013 were included in a single center cohort. Major adverse cardiovascular events (MACE) were then compared between the two groups. Among 284 patients with CLI, 68 (24%) had ncABIs. These patients were more likely to have coronary artery disease ( p=0.003), diabetes ( p<0.001), end-stage renal disease ( p<0.001) and tissue loss ( p=0.01) when compared to patients with cABI. Rates of infrapopliteal disease were similar between the two groups ( p=0.10), though patients with ncABI had lower rates of iliac ( p=0.004) or femoropopliteal stenosis ( p=0.003). Infrapopliteal vessels had smaller diameters ( p=0.01) with longer lesions ( p=0.05) among patients with ncABIs. After 3 years of follow-up, ncABIs were associated with increased rates of mortality (HR 1.75, 95% CI: 1.12–2.78), MACE (HR 2.04, 95% CI: 1.35–3.03) and major amputation (HR 1.96, 95% CI: 1.11–3.45) when compared to patients with cABIs. In conclusion, ncABIs are associated with higher rates of mortality and adverse events among those undergoing endovascular therapy for CLI.

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Abstract 14293: Time to Wound Healing and Major Adverse Limb Events in Patients With Critical Limb Ischemia Treated With Endovascular Therapy

Circulation ◽

10.1161/circ.132.suppl_3.14293 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Grant W Reed ◽

Negar Salehi ◽

Pejman Raeisi-Giglou ◽

Umair Malik ◽

Rami Kafa ◽

...

Keyword(s):

Wound Healing ◽

Endovascular Therapy ◽

Critical Limb Ischemia ◽

Proportional Hazards ◽

Limb Ischemia ◽

Major Amputation ◽

Cox Proportional Hazards ◽

Time Dependent ◽

Kaplan Meier

Introduction: There have been few studies evaluating the influence of time to wound healing on outcomes in patients with critical limb ischemia (CLI) after endovascular therapy. Methods: In this prospective study, patients with CLI treated with endovascular therapy were assessed for comorbidities, presence of wounds, wound healing, and major adverse limb events (MALE; major amputation, surgical endartectomy, or bypass) over time. The incidence of MALE was compared across patient and wound characteristics by Kaplan-Meier analysis. Associations between these variables and MALE were determined by Cox proportional hazards analysis. Results: A total of 252 consecutive patients with CLI were treated between November 1, 2011 and April 1, 2015; 179 (71%) had wounds, of which 97 (54%) healed. During median follow-up of 12.7 months (interquartile range 3.9 - 23.9 months), 46 (18%) had MALE. Wounds were associated with a greater risk of MALE (Hazard Ratio [HR] 3.5; 95% Confidence Interval [CI] 1.4-8.9; p=0.008). As a time-dependent covariate, wound healing was associated with less MALE (HR 0.23; 95% CI 0.10-0.53; p<0.001), and MALE was more frequent in patients with unhealed wounds (23% vs 11%; p<0.0001) (Figure - A). There was significantly less MALE in patients whose wounds healed within 4 months (24% vs 10%; p=0.032) (Figure - B), and less major amputation in those with healed wounds within 3 months (16% vs 5%; p=0.033). After multivariate adjustment for age, presence of diabetes, renal function, wound size, and procedural failure, independent predictors of MALE were wound healing as a time-dependent covariate (HR 0.18; 95% CI 0.08 - 0.40; p<0.0001), and creatinine ≥ 2 (HR 2.3; 95% CI 1.3-4.2; p=0.005). Conclusions: A shorter time to wound healing is associated with less MALE in patients with CLI after endovascular therapy. Efforts should be made to achieve wound healing as quickly as possible in this population, especially in those with renal dysfunction.

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Abstract MP17: Galectin-3 and Subsequent Risk of Lower-extremity Peripheral Artery Disease: The Atherosclerosis Risk in Communities (ARIC) Study

Circulation ◽

10.1161/circ.137.suppl_1.mp17 ◽

2018 ◽

Vol 137 (suppl_1) ◽

Author(s):

Kunihiro Matsushita ◽

Chao Yang ◽

Shoshana H Ballew ◽

John W McEvoy ◽

Maya Salameh ◽

...

Keyword(s):

Lower Extremity ◽

Peripheral Artery Disease ◽

Limb Ischemia ◽

Continuous Variable ◽

Tissue Loss ◽

Peripheral Artery ◽

Cox Models ◽

Galectin 3 ◽

Table Model ◽

Artery Disease

Background: Galectin-3 is involved in the regulation of inflammation and the formation of fibrosis and has been liked to atherosclerosis. However, there are no studies investigating prospective associations of galectin-3 with incidence of lower-extremity peripheral artery disease (PAD). Methods: Among 9,827 ARIC participants without a history of PAD, we investigated whether galectin-3 (measured at visit 4 [1996-98]) was associated with incident clinical PAD through 2013, defined as hospitalizations with PAD diagnosis or leg revascularization. We defined PAD cases with rest pain or tissue loss as critical limb ischemia (CLI). We constructed Cox models with galectin-3 modeled categorically (quartiles) and continuously (log transformed). Results: During a median follow-up of 15.8 years, 287 participants developed PAD (105 incident CLI cases). In demographically adjusted models, galectin-3 demonstrated a dose-response association with incident PAD: hazard ratios (HRs) 2.55 (95% CI 1.80-3.61) and 1.69 (1.18-2.41) for the highest and second highest quartiles, as compared to the lowest quartile (Table; Model 1). Additional adjustment for traditional cardiovascular risk factors attenuated the associations, although the highest quartile remained borderline significant (HR 1.44 [0.99-2.07], p=0.051, Table: Model 2) and galectin-3 as a continuous variable remained significant (1.15 [1.02-1.29]). Similar results were observed for the association of galectin-3 with CLI. Conclusions: Galectin-3 was modestly associated with future risk of clinical PAD events in a community-based cohort, supporting the involvement of inflammation and fibrosis in the development of clinical PAD.

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Percutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System

Journal of Endovascular Therapy ◽

10.1177/15266028211034862 ◽

2021 ◽

pp. 152660282110348

Author(s):

Grzegorz Halena ◽

Dainis K. Krievins ◽

Dierk Scheinert ◽

Janis Savlovskis ◽

Piotr Szopiński ◽

...

Keyword(s):

Venous Thrombosis ◽

Deep Venous Thrombosis ◽

Major Amputation ◽

Primary Patency ◽

Lesion Length ◽

Secondary Patency ◽

Femoropopliteal Bypass ◽

Chronic Total Occlusions ◽

Target Vessel Revascularization ◽

Kaplan Meier

Purpose: This study investigated the 2-year safety and effectiveness of the PQ Bypass DETOUR system as a percutaneous femoropopliteal bypass. Materials and Methods: Seventy-eight patients with 82 long-segment femoropopliteal lesions were enrolled in this prospective, single-arm, multicenter study. The DETOUR system deployed Torus stent grafts directed through a transvenous route. Eligible patients included those with lesions of >10 cm and average of 371±55 mm. Key safety endpoints included major adverse events (MAEs) and symptomatic deep venous thrombosis in the target limb. Effectiveness endpoints included primary patency defined as freedom from ≥50% stenosis, occlusion, or clinically-driven target vessel revascularization (CD-TVR), primary assisted, and secondary patency. Results: Chronic total occlusions and severe calcium occurred in 96% and 67% of lesions, respectively. Core laboratory-assessed total lesion length averaged 371±51 mm with a mean occlusion length of 159±88 mm. The rates of technical and procedural success were 96%, with satisfactory delivery and deployment of the device without in-hospital MAEs in 79/82 limbs. The MAE rate was 22.0%, with 3 unrelated deaths (4%), 12 CD-TVRs (16%), and 1 major amputation (1%). Deep venous thrombosis developed in 2.8% of target limbs, and there were no reported pulmonary emboli. Primary, assisted primary, and secondary patency rates by the Kaplan–Meier analysis were 79±5%, 79±5%, and 86±4%, respectively. Conclusions: The PQ Bypass DETOUR system is a safe and effective percutaneous alternative to femoropopliteal open bypass with favorable results through 2 years. The DETOUR system provides a durable alternative to conventional endovascular modalities and open surgery for patients with long, severely calcified, or occluded femoropopliteal lesions.

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Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study

Journal of Endovascular Therapy ◽

10.1177/1526602819839044 ◽

2019 ◽

Vol 26 (3) ◽

pp. 305-315 ◽

Cited By ~ 7

Author(s):

Michel M. P. J. Reijnen ◽

Iris van Wijck ◽

Thomas Zeller ◽

Antonio Micari ◽

Pierfrancesco Veroux ◽

...

Keyword(s):

Critical Limb Ischemia ◽

Limb Ischemia ◽

Target Lesion ◽

Major Amputation ◽

Limb Amputation ◽

Post Hoc Analysis ◽

Kaplan Meier ◽

Global Study ◽

Post Hoc ◽

Drug Coated Balloon

Purpose: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study ( ClinicalTrials.gov identifier NCT01609296). Materials and Methods: Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI). Results: Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p<0.001). The MAE rate through 12 months was higher in CLI subjects (22.5% vs 10.7%, p<0.001), and CLI patients had poorer overall survival (93.0%, 95% CI 88.9% to 97.2%) than IC subjects (97.0%, 95% CI 96.0% to 97.9%, p=0.011). Health status significantly improved in all domains at 6 and 12 months in both groups. Conclusion: Treatment of femoropopliteal disease with DCB in CLI patients is safe through 12-month follow-up, with a low major amputation rate of 1.4%. The rates of MAE and CD-TLR were higher in CLI subjects and reinterventions were required sooner. Additional research is needed to evaluate long-term outcomes of DCB treatment for femoropopliteal lesions in CLI patients.

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Below-knee endovascular interventions have better outcomes compared to open bypass for patients with critical limb ischemia

Vascular Medicine ◽

10.1177/1358863x16676901 ◽

2016 ◽

Vol 22 (1) ◽

pp. 28-34 ◽

Cited By ~ 10

Author(s):

Caitlin W Hicks ◽

Alireza Najafian ◽

Alik Farber ◽

Matthew T Menard ◽

Mahmoud B Malas ◽

...

Keyword(s):

Critical Limb Ischemia ◽

Multivariable Analysis ◽

Limb Ischemia ◽

Major Amputation ◽

Primary Patency ◽

Tissue Loss ◽

Vascular Intervention ◽

Below The Knee ◽

Endovascular Interventions ◽

One Year

Both open surgery and endovascular peripheral interventions have been shown to effectively improve outcomes in patients with peripheral artery disease, but minimal data exist comparing outcomes performed at and below the knee. The purpose of this study was to compare outcomes following infrageniculate lower extremity open bypass (LEB) versus peripheral vascular intervention (PVI) in patients with critical limb ischemia. Using data from the 2008–2014 Vascular Quality Initiative, 1-year primary patency, major amputation, and mortality were compared among all patients undergoing LEB versus PVI at or below the knee for rest pain or tissue loss. Overall, 2566 patients were included (LEB=500, PVI=2066). One-year primary patency was significantly worse following LEB (73% vs 81%; p<0.001). One-year major amputation (14% vs 12%; p=0.18) and mortality (4% vs 6%; p=0.15) were similar regardless of revascularization approach. Multivariable analysis adjusting for baseline differences between groups confirmed inferior primary patency following LEB versus PVI (HR 0.74; 95% CI, 0.60–0.90; p=0.004), but no significant differences in 1-year major amputation (HR 1.06; 95% CI, 0.80–1.40; p=0.67) or mortality (HR 0.71; 95% CI, 0.44–1.14; p=0.16). Based on these data, we conclude that endovascular revascularization is a viable treatment approach for critical limb ischemia resulting from infrageniculate arterial occlusive disease.

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Balloon Angioplasty in Chronic Critical Limb Ischemia: Factors Affecting Clinical and Angiographic Outcome

Journal of Endovascular Therapy ◽

10.1177/152660280200900403 ◽

2002 ◽

Vol 9 (4) ◽

pp. 403-410 ◽

Cited By ~ 30

Author(s):

Hannes Balmer ◽

Felix Mahler ◽

Dai-Do Do ◽

Jürgen Triller ◽

Iris Baumgartner

Keyword(s):

Balloon Angioplasty ◽

Critical Limb Ischemia ◽

Duplex Ultrasound ◽

Limb Ischemia ◽

Target Lesion ◽

Major Amputation ◽

Factors Affecting ◽

Chronic Critical Limb Ischemia ◽

Endpoint Event ◽

Artery Disease

Purpose: To assess factors that affect clinical and angiographic outcome in chronic critical limb ischemia (CLI) 12 months after primary, technically successful balloon angioplasty (BA) in infrainguinal arteries. Methods: Sixty consecutive patients (37 women; mean age 75 ± 10 years, range 53–99) with technically successful BA in 66 limbs were followed for 12 months or until death, for major amputation, or repeat target lesion revascularization (TLR). Assessment at baseline and 1 day and 12 months after BA or at an endpoint event, if feasible, was performed with angiography or duplex ultrasound (above-knee revascularization only). Mortality, limb prognosis, and restenosis rate were correlated with cardiovascular risk factors, hemodynamic measures, and angiographic features. Results: Mortality was 25% at 1 year; compared to survivors, nonsurvivors more often had coronary artery disease (93% versus 44% for survivors, p<0.001), bilateral CLI (60% versus 29%, p=0.033), and higher fibrinogen levels (5.1 g/L versus 4.3 g/L, p=0.049). CLI resolved in more than half (35, 53%) of the limbs without repeat TLR. The major amputation rate was 6%. Limb prognosis correlated with ankle pressures after BA. Restenosis rates were 65% at the femoropopliteal and 56% at the infrapopliteal level (NS); these correlated with the length of the treated arterial segment (8.7 cm with restenosis versus 4.0 cm without, p<0.001). Conclusions: High mortality in CLI was associated with an extensive, clinically manifest arteriosclerotic process and high fibrinogen levels. Limb prognosis and restenosis after BA were primarily influenced by local hemodynamic and technical factors. Despite considerable restenosis, more than 90% of survivors avoided major amputations.

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A Review and Proposed Classification System for the No-Option Patient With Chronic Limb-Threatening Ischemia

Journal of Endovascular Therapy ◽

10.1177/1526602820963911 ◽

2020 ◽

pp. 152660282096391

Author(s):

Tanner I. Kim ◽

Shant S. Vartanian ◽

Peter A. Schneider

Keyword(s):

Treatment Strategies ◽

Major Amputation ◽

Occlusive Disease ◽

Tissue Loss ◽

Type I ◽

Type Ii ◽

Type Iii ◽

Type Iv ◽

Foot Anatomy ◽

Type V

A growing, but poorly defined subset of patients with chronic limb-threatening ischemia (CLTI) have “no option” for revascularization. One notable subgroup includes patients with severe ischemia and advanced pedal artery occlusive disease, termed “desert foot,” who are at high risk for major amputation due to a lack of conventional revascularization options. Although new therapies are being developed for no-option patients with desert foot anatomy, this subgroup and the broader group of no-option patients are not well defined, limiting the ability to evaluate outcomes. Based on a systematic review, a classification of the no-option CLTI patient was constructed for use in clinical practice and studies. Several no-option conditions were identified, including type I—severe and pedal occlusive disease (desert foot anatomy) for which there is no accepted method of repair; type II—lack of suitable venous conduit for bypass in the setting of an acceptable target for bypass; type III—extensive tissue loss with exposure of vital structures that renders salvage impossible; type IV—advanced medical comorbidities for which available revascularization options would pose a prohibitive risk; and type V—presence of a nonfunctional limb. While type I and type II patients may have no option for revascularization, type III and type V patients have wounds, infection, comorbidities, or functional status that may leave them with few options for revascularization. As treatment strategies continue to evolve and novel methods of revascularization are developed, the ability to identify no-option patients in a standardized fashion will aid in treatment selection and assessment of outcomes.

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Association of comorbid depression with inpatient outcomes in critical limb ischemia

Vascular Medicine ◽

10.1177/1358863x19880277 ◽

2019 ◽

Vol 25 (1) ◽

pp. 25-32 ◽

Cited By ~ 2

Author(s):

Greg J Zahner ◽

Abigail Cortez ◽

Erin Duralde ◽

Joel L Ramirez ◽

Sue Wang ◽

...

Keyword(s):

Length Of Stay ◽

Critical Limb Ischemia ◽

Multivariable Analysis ◽

Limb Ischemia ◽

Major Amputation ◽

Comorbid Depression ◽

Surgical Quality ◽

Inpatient Outcomes ◽

Artery Disease ◽

End Stage

There is a growing body of evidence that peripheral artery disease (PAD) may be impacted by depression. The objective of this study is to determine whether outcomes, primarily major amputation, differ between patients with depression and those without who presented to hospitals with critical limb ischemia (CLI), the end-stage of PAD. A retrospective cohort of patients hospitalized for CLI during 2012 and 2013 was identified from the National Inpatient Sample (NIS) using ICD-9 codes. The primary outcome was major amputation and secondary outcomes were length of stay and other complications. The sample included 116,008 patients hospitalized for CLI, of whom 10,512 (9.1%) had comorbid depression. Patients with depression were younger (64 ± 14 vs 67 ± 14 years, p < 0.001) and more likely to be female (55% vs 41%, p < 0.001), white (73% vs 66%, p < 0.001), and tobacco users (46% vs 41%, p < 0.001). They were also more likely to have prior amputations (9.8% vs 7.9%, p < 0.001). During the hospitalization, the rate of major amputation was higher in patients with comorbid depression (11.5% vs 9.1%, p < 0.001). In multivariable analysis, excluding patients who died prior to/without receiving an amputation ( n = 2621), comorbid depression was associated with a 39% increased odds of major amputation (adjusted OR 1.39, 95% CI 1.30, 1.49; p < 0.001). Across the entire sample, comorbid depression was also independently associated with a slightly longer length of stay (β = 0.199, 95% CI 0.155, 0.244; p < 0.001). These results provide further evidence that depression is a variable of interest in PAD and surgical quality databases should include mental health variables to enable further study.

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