The Impact of Functional Status on the Outcomes of Endovascular Lower Extremity Revascularization for Critical Limb Ischemia in the Elderly

Accepted Manuscript The Impact of Functional Status on the Outcomes of Endovascular Lower Extremity Revascularization for Critical Limb Ischemia in the Elderly Isidore Dinga Madou, MD, Martin D. Slade, MPH, Kristine C. Orion, MD, Timur Sarac, MD, Cassius Iyad Ochoa Chaar, MD PII:

S0890-5096(17)30139-5

DOI:

10.1016/j.avsg.2017.06.047

Reference:

AVSG 3442

To appear in:

Annals of Vascular Surgery

Received Date: 31 January 2017 Revised Date:

24 April 2017

Accepted Date: 5 June 2017

Please cite this article as: Madou ID, Slade MD, Orion KC, Sarac T, Ochoa Chaar CI, The Impact of Functional Status on the Outcomes of Endovascular Lower Extremity Revascularization for Critical Limb Ischemia in the Elderly, Annals of Vascular Surgery (2017), doi: 10.1016/j.avsg.2017.06.047. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Isidore Dinga Madou1,2, MD, Martin D. Slade3, MPH, Kristine C. Orion2, MD, Timur Sarac2, MD, Cassius Iyad Ochoa Chaar2, MD

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Yale New Haven Hospital, Yale University School of Medicine, Department of Surgery, Sections of 1General Surgery and 2Vascular Surgery; 3Department of Internal Medicine, Section of Occupational and Environmental Medicine, New Haven, Connecticut.

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Key words: Functional status, Endovascular, Revascularization, critical limbs ischemia, elderly, outcomes

Disclosure: The authors have nothing to disclose

Corresponding Author:

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Cassius Iyad Ochoa Chaar, MD, MS, FACS Assistant Professor of Surgery Section of Vascular Surgery Yale University School of Medicine 333 Cedar Street, Boardman 204 PO Box 208062 New Haven, CT 06520-8039 Telephone: 203-785-2561 Fax: 203-785-7556

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The Impact of Functional Status on the Outcomes of Endovascular Lower Extremity Revascularization for Critical Limb Ischemia in the Elderly

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AUTHORS: Isidore Dinga Madou1,2, MD, Martin D. Slade3, MPH, Kristine C. Orion2, MD, Timur Sarac2, MD, Cassius Iyad Ochoa Chaar2, MD Yale New Haven Hospital, Yale University School of Medicine, Department of Surgery, Sections of 1General Surgery and 2Vascular Surgery; 3Department of Internal Medicine, Section of Occupational and Environmental Medicine, New Haven, Connecticut.

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INTRODUCTION: Functional status is an important predictor of outcomes after infrainguinal bypass surgery. There is little data on the effect of functional status on the outcomes of endovascular LE interventions, especially in the elderly frail population.

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METHODS: This is a retrospective analysis of the American College of Surgeons - National Surgical Quality Improvement Program (ACS-NSQIP) files for the years 2011-2013 to assess the impact of functional status on outcome after endovascular intervention for critical limb ischemia. Elderly patients (Age ≥ 70) undergoing revascularization for critical limb ischemia (CLI) were included. The patients were divided into 2 groups based on functional status prior to surgery: Independent (IND) or Dependent (DEP) which included partially dependent as well as totally dependent patients. The two groups were compared with respect to demographics, comorbidities, complications, length of stay, limb loss and mortality. Statistical analysis was performed using student’s t-test for continuous variables and Fisher exact test for categorical variables.

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RESULTS: There were 1055 patients (DEP = 253, 24%). There was no difference in gender or race but DEP patients were older than IND (P=0.008). DEP patients were significantly more likely to have history of congestive heart failure (P=0.003), hypertension (P=0.042), and diabetes (P<.001). There was no difference in emergent surgeries between the 2 groups (P=1.00). DEP patients had more tibial interventions compared to IND (P<.001). DEP developed more pneumonia (P<.001) and septic shock (P=0.016) and had a trend towards more urinary tract infections (P=0.051) after endovascular revascularization. There was no significant difference in operating time (P=0.232) or major amputation (P=0.092). DEP had significantly longer length of hospital stay (P=0.0068). DEP had significantly higher mortality (5.98% vs 2.01%, P=0.002). On Multivariate analysis, DEP status, emergency procedure, CHF, cardiac arrest requiring CPR, MI, sepsis and septic shock were independently associated with 30 days mortality. Irrespective of age, DEP functional status was the most significant preoperative predictor of mortality with an odd ratio of 5.16 [1.93 – 13.83], p=0.001 (Parsimonious Model).

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The Impact of Functional Status on the Outcomes of Endovascular Lower Extremity Revascularization for Critical Limb Ischemia in the Elderly

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CONCLUSIONS: Functional status should be carefully assessed when considering endovascular revascularization in the elderly as DEP have significantly higher morbidity and mortality.

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Introduction The advances in medical knowledge and technology have increased the life expectancy of

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the American population. Individuals of age 85 or older constituted 1.9% of the population in

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2010 and that number is expected to rise to 4.3% by 2050.1 New challenges are arising as very

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old and frail patients with critical limb ischemia (CLI) are being referred for vascular evaluation.

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It has been shown that lower extremity (LE) revascularization improves quality of life and

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survival in elderly patients with CLI as compared to conservative therapy or amputation.2-4

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Despite technical success, the benefit of revascularization in that patient population is limited by

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increased comorbidities and higher risk of complications.5, 6 Functional status has been shown to

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be an important predictor of mortality after open LE revascularization with infrainguinal bypass

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surgery in a large single center series by Taylor et al. and subsequently using the ACS-NSQIP

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database by Crawford et al.4-7 There is little data on the effect of functional status on the

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outcomes of endovascular LE interventions. This study aims to highlight the impact of functional

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status on the outcomes of endovascular LE revascularization for CLI in the elderly population.

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Methods

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Database ACS-NSQIP is a prospective de-identified database of operative cases collected from

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a large number of centers in the United States. It was started as a quality improvement program

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in the Veterans Affairs health system and subsequently expanded to the private sector.8, 9

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Preoperative patient characteristics, risk factors, and postoperative outcomes up to 30 days are

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collected by trained clinical nurses. In 2011, the program added variables targeting specific

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procedures in different specialties. The ACS-NSQIP files targeting endovascular infrainguinal

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LE revascularization from 2011-2013 were reviewed. The targeted files provide additional

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information regarding indication, anatomical level, and outcomes with respect to limb salvage

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specifically.

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Elderly patients (Age ≥ 70) undergoing revascularization for critical limb ischemia (CLI defined

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as rest pain or tissue loss) were included. Patients undergoing interventions for claudication were

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excluded. The study was approved by the IRB at Yale University and patient consent was

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exempt since the database does not contain any patient identifier.

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Variables

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The ACS NSQIP database stratifies surgical patients based on their ability to perform activities

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of daily living which include bathing, feeding, dressing, toileting, and mobility. The best

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functional status demonstrated by the patient within the 30 days prior to surgery is reported. An

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independent patient does not require assistance from another person for any activities of daily

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living. This includes a person who is able to function independently with prosthetics, equipment,

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or devices. Partially dependent and totally dependent patients require assistance from another

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person for some or all activities of daily living respectively. The patients in the current study

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were divided into 2 groups based on pre-operative functional status as independent (IND) or

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dependent (DEP) which included partially dependent as well as totally dependent patients.

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The two groups were compared with respect to baseline demographic characteristics as

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well as comorbidities. The anatomical level of intervention as well as duration of the procedure

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were noted. Concurrent and other CPT codes were reviewed for open surgical revascularization

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indicating that the endovascular intervention was part of a hybrid procedure. The primary

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outcome was to compare 30-day mortality. Secondary outcomes entailed comparing superficial

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site infection, pneumonia, progressive renal insufficiency, urinary tract infection,

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cerebrovascular accident (CVA)/stroke, myocardial infarction, bleeding, sepsis, septic shock as

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well as total hospital length of stay, and major amputation at 30 days.

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Statistical Analysis

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Initially, variables were examined using descriptive statistics. Bivariate associations were evaluated using Student’s t-test for continuous variables and either Chi-square or, where

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counts within a given cell were below five, Fisher’s exact test for categorical variables.

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Multivariate logistic regression modeling was performed to determine predictors of 30-day

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survival for the full model as well as the parsimonious model after exclusion of hybrid

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procedures. The parsimonious model was developed utilizing a backward elimination procedure

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with a significance level to stay of 95% (α=0.05). Odds ratios (OR) were used to determine

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direction and magnitude of effect of variables on mortality. For all analyses, significance was

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defined with α=0.05. All statistical analyses were performed using SAS version 9.4 (SAS

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institute, NC).

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Results

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Demographics and comorbidities

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endovascular intervention for CLI. There was no difference in gender or race but DEP patients

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were significantly older than IND (P=0.008). DEP patients were significantly more likely to have

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diabetes (P<.001), history of congestive heart failure (CHF) (P=0.003), hypertension (P=0.042),

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and diabetes (P<.001), while IND patients were more likely to be smokers (P=0.004), but there

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was no difference in the diagnosis of COPD between the 2 groups (P=0.319). Finally, there was

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no difference in the proportion of patients on dialysis (P=0.245). (Table 1)

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There were 1048 patients (DEP = 251, 24%) with age 70 or older who underwent LE

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152 153 154

Procedures

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(P=1.00). DEP patients tended to have more tibial interventions while independent patients had

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more femeropopliteal interventions (P<.001). Also, endovascular interventions in IND patients

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were significantly more likely to be part of a hybrid procedure (10.16% vs 3.98%) compared to

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DEP patients (P<.002). All concurrent and other CPT codes were individually reviewed and

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summarized (appendix A). The most common concomitant open surgery was iliofemoral

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thromboendarterectomy (n=57) followed by lower extremity thrombectomy (n = 18). Finally,

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there was no difference in operating time (P=0.232) or type of anesthesia (P=0.306).

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As depicted in table 2, there was no difference in emergent surgeries between the 2 groups

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Outcomes

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DEP patients had statistically significant higher mortality rate compared to IND patients (5.98%

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vs 2.01%, P=0.002) but there was no difference in major amputations (p=0.092). DEP developed

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more postoperative pneumonia (P=0.001) and septic shock (P=0.016), and had significantly

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longer length of hospital stay (8.5 ± 13.96 days vs 4.5 ± 7.68, P<.001) as compared to IND.

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There was a trend towards more urinary tract infections (P=0.051) after endovascular

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revascularization among DEP patient, but this was not statically significant. There was no

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significant difference in rate of sepsis occurrence, superficial surgical site infection, progressive

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renal insufficiency, CVA/stroke, myocardial infarction, and bleeding (Table 3).

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Risk factors for mortality Collinearity between variables was evaluated prior to conducting multivariate analyses.

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Although there is a statistically significant correlation between age and functional status

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(p=0.021), it is very weak at r=0.075. With regard to the final statistical model, the only

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meaningful collinearity observed was between cardiac arrest and reintubation with a correlation

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of 0.563 p<.001. Nonetheless, both of these variables were kept in the model as they were each

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measures of complications and the model estimates for the predictor, functional health, were

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adjusted for their combined effects (along with the effects of the other variables in the model).

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Table 4 shows all variables associated with mortality on bivariate analysis using the full

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and parsimonious models after exclusion of hybrid procedures. Using the full model,

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Preoperative dependent functional status (OR = 5.27 [1.64 -16.95]) and history of congestive

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heart failure (OR = 4.46 [1.20 – 16.57]) were significantly associated with mortality. There was

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no statistically significant association between gender, race, type of procedure, diabetes, smoking,

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renal failure, or type of anesthesia with mortality. Interestingly enough, there was no statistically

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significant increase in mortality when nonagenarians (OR = 3.5 [0.63 -19.33]) and octogenarians

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(OR = 1.59 [0.45 – 5.22]) were compared to septuagenarians (P=0.355). Post-operative

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myocardial infarction (OR = 33.46 [4.93 – 227.16]), cardiac arrest requiring CPR (21.32 [2.07 –

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219.46]), sepsis (OR = 27.24 [2.97 – 249.69]), and septic shock (OR = 10.09[1.46 – 69.63]) were

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also associated with mortality in both models. Multivariate analysis with parsimonious models

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demonstrates that the same risk factors remained significant with addition of emergency

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procedure and reintubation after accounting for age, gender, race, diabetes, smoking,

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hypertension, renal failure, anesthesia type, and other complications (pneumonia, progressive

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renal insufficiency, acute renal failure, stroke, bleeding, and return to OR

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Table 5 serves as a quick reference for the clinician to assess risk of mortality based on

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the functional status of elderly patients before endovascular interventions for CLI. Patients with

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hybrid interventions were excluded to emphasize the trend in patients with percutaneous

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endovascular interventions. In the DEP group, the mortality rises with each decade of age up to

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12.50% in nonagenarians while it remains stable around 2% as age increases in the IND group.

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Discussion

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Functional status is as an important determinant of the outcomes of open and endovascular lower

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extremity revascularization.4, 7, 10, 11 An increased level of dependence is associated with inferior

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patency, higher limb loss and decreased overall survival for treatment of CLI especially in the

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elderly.4, 11 On the other hand, multiple studies have demonstrated that revascularization is the

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optimal treatment for CLI in octogenarians4, 12, 13 and nonagenarians6, 13 in order to achieve limb

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salvage and maintain walking ability. An endovascular approach first has been advocated for

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revascularization in octogenarians as a better tolerated modality of treatment compared to open

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surgical bypass.3, 5, 12 However, the perioperative mortality of endovascular revascularization for

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PAD in the elderly has been reported to be as low as 2% and as high as 12% in different series5, 6,

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12-14

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underscores the different degrees of severity of comorbidities in the elderly population. Similar

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to other studies,4, 10 our results show that dependent patients are older and have more

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comorbidities. Interestingly, a dependent functional status prior to endovascular LE

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revascularization for CLI was the most significant predictor of postoperative mortality. On the

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other hand, age was not a predictor of mortality in that group of patients. In fact, as shown in

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table 5, the perioperative mortality of LE revascularization did not change significantly between

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septuagenarians, octogenarians, and nonagenarians in the patients with independent functional

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with complications reaching up to 18%15. The variability in mortality is multifactorial and

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status. In contradistinction, mortality was higher in dependent patients and increased with each

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decade of life. The numbers in table 5 pertain to endovascular procedures only (hybrid

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procedures were excluded) and explain the variability in mortality reported in the literature (2-

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12%).5, 6, 12-14 The results support an aggressive approach for limb salvage in independent elderly

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patients using endovascular therapy. However, caution should be exercised in the care of

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dependent elderly patients, especially nonagenarians, since percutaneous, minimally invasive

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procedures may not be as “safe” and low risk as usually perceived. Table 5 serves as a guide for

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clinicians to assess the risk of procedural mortality after percutaneous endovascular

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revascularization for elderly patients with CLI.

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PAD and CHF share common risk factors and patients with PAD are twice as likely to have

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CHF.16 CHF was associated with postoperative mortality after infrainguinal bypass surgery

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based on an analysis of the NSQIP database. CHF also increased the odds of pneumonia,

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prolonged intubation, reintubation, as well as sepsis and septic shock after bypass surgery.17

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Meltzer at al. demonstrated that CHF was an independent risk factor for reduced patency after

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endovascular LE revascularization and an ejection fraction less than 40% was associated with

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higher limb loss in patients treated for CLI. The population studied was relatively younger (mean

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age = 74 for patients with CHF) and patients with CHF did not have a significant difference in

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perioperative mortality compared to patients without CHF.18 Our study demonstrates that history

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of CHF and developing myocardial infarction or cardiac arrest after endovascular LE

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revascularization were predictors of mortality in this elderly group with CLI. These findings are

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consistent with the literature underscoring the presence of cardiac disease in elderly patients with

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CLI as a major determinant of outcome.5, 13, 14, 19

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Dependent patients developed more postoperative complications compared to independent

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patients after revascularization for CLI. There was a significantly higher incidence of

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postoperative pneumonia and sepsis and a trend toward higher incidence of UTI. Dependent

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functional status was found to be an independent predictor of postoperative pneumonia in a study

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examining the 2007-2008 NSQIP data sets. It was incorporated as one of 7 variables to develop a

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predictive model risk calculator for postoperative pneumonia after different types of surgeries

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and was validated.20 Even though pneumonia per se was not a predictor of mortality in our

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analysis, it could have contributed to reintubation, sepsis, and septic shock which were all

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predictors of mortality. In studying the aging population of Japan, Kosai et al. demonstrated that

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increasing dependence in activities of daily living correlated with increased mortality from

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healthcare-associated pneumonia as well as community acquired pneumonia.21 Interestingly,

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despite undergoing more invasive surgeries (higher percentage of hybrid procedures),

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independent patients in our study had significantly lower morbidity and mortality than dependent

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patients.

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There are several limitations to this study. First, this is a study based exclusively on an

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administrative database. Because of the ACS-NSQIP database Its retrospective nature and

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limited data to the variables available in the files and up to only 30 days, it is impossible to

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assess the extent of disease and the duration of symptoms and intermediate- or long-term

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outcomes of individuals are not available. Also Second, it is not possible to determine whether

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patients had prior open or endovascular interventions. Third, by the nature of the ACS-NSQIP

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database, only patients treated in the operating room were included. It is possible that the

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procedures were performed in an operating room because of anesthesia monitoring that is

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sometimes required for high risk patients. Therefore, elderly patients treated for CLI by

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outpatient endovascular intervention in an angiography suite were not captured. Functional

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status was categorized based on the ability of patients to perform activities of daily living. That

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was determined by trained nurses but is partially subjective and depends on patients own

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perceptions. As such, considerable variability could be expected in the determination of

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dependent status. Also, the ACS-NSQIP database does not provide information on medical

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therapy for PAD which is known to impact outcomes of interventions. Last, but not least, the

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influence of coding errors and inaccuracies could not be ascertained.

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Conclusion

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This study highlights the importance of assessing the functional status of elderly with CLI when

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considering endovascular revascularization. A dependent functional status associated with older

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age not only curtails the long-term benefits of limb salvage but also increases the perioperative

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risks of percutaneous endovascular procedures. A careful assessment of the risks and benefits of

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intervention in that group of patients with CLI is warranted.

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References:

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1. US Departemnent of Health and Human Services. Data and Statistic of Aging population. http://www.aoa.acl.gov/Aging_Statistics. accessed 11/1/2015. 2. Klevsgard R, Risberg BO, Thomsen MB, Hallberg IR. A 1-year follow-up quality of life study after hemodynamically successful or unsuccessful surgical revascularization of lower limb ischemia. Journal of vascular surgery. 2001;33(1):114-22. 3. Brosi P, Dick F, Do DD, Schmidli J, Baumgartner I, Diehm N. Revascularization for chronic critical lower limb ischemia in octogenarians is worthwhile. Journal of vascular surgery. 2007;46(6):1198-207. 4. Taylor SM, Kalbaugh CA, Blackhurst DW, Langan EM, 3rd, Cull DL, Snyder BA, et al. Postoperative outcomes according to preoperative medical and functional status after infrainguinal revascularization for critical limb ischemia in patients 80 years and older. The American surgeon. 2005;71(8):640-5; discussion 5-6. 5. Arvela E, Venermo M, Soderstrom M, Korhonen M, Halmesmaki K, Alback A, et al. Infrainguinal percutaneous transluminal angioplasty or bypass surgery in patients aged 80 years and older with critical leg ischaemia. Br J Surg. 2011;98(4):518-26. 6. Saarinen E, Vuorisalo S, Kauhanen P, Alback A, Venermo M. The benefit of revascularization in nonagenarians with lower limb ischemia is limited by high mortality. European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. 2015;49(4):420-5. 7. Crawford RS, Cambria RP, Abularrage CJ, Conrad MF, Lancaster RT, Watkins MT, et al. Preoperative functional status predicts perioperative outcomes after infrainguinal bypass surgery. Journal of vascular surgery. 2010;51(2):351-8; discussion 8-9. 8. Khuri SF, Daley J, Henderson W, Hur K, Demakis J, Aust JB, et al. The Department of Veterans Affairs' NSQIP: the first national, validated, outcome-based, risk-adjusted, and peercontrolled program for the measurement and enhancement of the quality of surgical care. National VA Surgical Quality Improvement Program. Ann Surg. 1998;228(4):491-507. 9. Fink AS, Campbell DA, Jr., Mentzer RM, Jr., Henderson WG, Daley J, Bannister J, et al. The National Surgical Quality Improvement Program in non-veterans administration hospitals: initial demonstration of feasibility. Ann Surg. 2002;236(3):344-53; discussion 53-4. 10. Flu HC, Lardenoye JH, Veen EJ, Van Berge Henegouwen DP, Hamming JF. Functional status as a prognostic factor for primary revascularization for critical limb ischemia. Journal of vascular surgery. 2010;51(2):360-71 e1. 11. Oresanya L, Zhao S, Gan S, Fries BE, Goodney PP, Covinsky KE, et al. Functional outcomes after lower extremity revascularization in nursing home residents: a national cohort study. JAMA Intern Med. 2015;175(6):951-7. 12. Dosluoglu HH, Lall P, Cherr GS, Harris LM, Dryjski ML. Superior limb salvage with endovascular therapy in octogenarians with critical limb ischemia. Journal of vascular surgery. 2009;50(2):305-15, 16 e1-2; discussion 15-6. 13. Salas CA, Adam DJ, Papavassiliou VG, London NJ. Percutaneous transluminal angioplasty for critical limb ischaemia in octogenarians and nonagenarians. European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. 2004;28(2):142-5. 14. Zdanowski Z. Outcome and influence of age after infrainguinal revascularization in critical limb ischemia. Eur J Surg Suppl. 1998(581):42-4.

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15. Dick P, Barth B, Mlekusch W, Sabeti S, Amighi J, Schlager O, et al. Complications after peripheral vascular interventions in octogenarians. Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists. 2008;15(4):383-9. 16. Anand RG, Ventura HO, Mehra MR. Is heart failure more prevalent in patients with peripheral arterial disease? A meta-analysis. Congest Heart Fail. 2007;13(6):319-22. 17. Amdur RL, Ashby B, Neville R, Tunstall A, Nguyen BN, Sidawy A. The effect of congestive heart failure on perioperative outcomes in patients undergoing lower extremity revascularization. Journal of vascular surgery. 2016;63(5):1289-95. 18. Meltzer AJ, Shrikhande G, Gallagher KA, Aiello FA, Kahn S, Connolly P, et al. Heart failure is associated with reduced patency after endovascular intervention for symptomatic peripheral arterial disease. Journal of vascular surgery. 2012;55(2):353-62. 19. Chang JB, Stein TA. Infrainguinal revascularizations in octogenarians and septuagenarians. Journal of vascular surgery. 2001;34(1):133-8. 20. Gupta H, Gupta PK, Schuller D, Fang X, Miller WJ, Modrykamien A, et al. Development and validation of a risk calculator for predicting postoperative pneumonia. Mayo Clin Proc. 2013;88(11):1241-9. 21. Kosai K, Izumikawa K, Imamura Y, Tanaka H, Tsukamoto M, Kurihara S, et al. Importance of functional assessment in the management of community-acquired and healthcareassociated pneumonia. Intern Med. 2014;53(15):1613-20.

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Table 1: Demographics and Comorbidities Independent (n=797)

% (n)

% (n)

70-80

45.42% (114)

54.33% (433)

80-90

41.04% (103)

90 plus

13.55% (34)

Male

46.22% (116)

Female

53.78% (135

48.31% (385)

White

70.52% (177)

73.9% (589)

Demographics and Comorbidities

Age category

Gender

0.148

13.55% (34)

12.55% (100)

7.17% (18)

13.8% (110)

0.004

66.93% (168)

52.82% (421)

<.001

13.94% (168)

11.54% (92)

0.319

History of CHF

9.96% (25)

4.52% (36)

0.003

Hypertension

92.03% (231)

87.33% (696)

0.042

Dialysis (pre-op)

12.75% (32)

10.16% (81)

0.245

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COPD: Chronic Obstructive Pulmonary Disease, CHF: Congestive Heart Failure, Pre-op: Preoperative

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354 355 356 357 358 359 360 361 362 363 364 365 366

51.69% (412)

Other

History of COPD

353

7.9% (63)

13.55% (108)

Diabetes

352

0.008

15.94% (40)

Smoking

Comorbidity

37.77% (301)

Black or African American

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P-value

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Dependent (n=251)

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0.522

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Characteristics

Emergency case Femoropopliteal Primary intervention level

Independent (n=797)

% (n)

% (n)

4.78% (12)

4.64% (37)

1.000

55.18% (141)

69.13% (551)

43.82% (110)

30.87% (246)

3.98% (10)

10.16% (81)

19.52% (49)

19.32% (154)

74.50% (187)

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71.64% (571)

5.98% (15)

9.03% (72)

103.7 ± 0.69

109.7 ± 70.38

General MAC/IV sedation Other Total operation time (Minutes)

MAC: Monitored Anesthesia Care, IV: Intravenous

370 371 372

Table 3 Outcomes

< .002

0.306

0.232

Dependent (n=251)

Independent (n=797)

% (n)

% (n)

AC C

TE D

369

P-value

<.001

Tibial

Hybrid Procedures

Anesthesia

Dependent (n=251)

RI PT

Table 2: Procedures

SC

367 368

Pneumonia

3.19% (8)

0.38% (3)

<.001

Urinary tract infection

3.19% (8)

1.25% (10)

0.051

Sepsis

2.39% (6)

1.25% (10)

0.235

Septic shock

2.39% (6)

0.50% (4)

0.016

EP

Complications

P-value

ACCEPTED MANUSCRIPT

0.40% (1)

2.01% (16)

0.09

Progressive renal insufficiency

1.59% (4)

0.63% (5)

0.230

CVA/Stroke

0.40% (1)

0.63% (5)

1.000

Myocardial infarction

1.20% (3)

2.13% (17)

0.436

Bleeding

9.56% (24)

Mortality 373

CVA: Cerebrovascular Accident

EP AC C

SC

1.000

6.77% (17)

4.14% (33)

0.092

5.98% (15)

2.01% (16)

0.002

TE D

374

9.41% (75)

M AN U

Major amputation

RI PT

Surgical site infection

ACCEPTED MANUSCRIPT

Table 4: Risk factors and Independent predictors of 30-Day Mortality without hybrid procedures: Full and Parsimonious Models Parameter

Level

Functional status

Age category Procedure type

PMH

P-value

Odds Ratio [95% CI]

P-value

Dependent

5.27 [1.64 - 16.95]

0.005

5.16 [1.93 - 13.83]

0.001

Female Black or African American

0.44 [0.17 - 134]

0.167

0.24 [0.03 - 1.99] 1.22 [0.27 - 5.44]

90+

3.50 [0.63 - 19.33]

80 – 89

1.59 [0.45 - 5.22]

70 – 79

1 (reference)

Emergency

3.76 [0.67 - 20.56]

Diabetes

0.85 [0.27 - 2.67]

0.781

Smoking

0.29 [0.18 - 4.63]

0.380

History of CHF

4.46 [1.20 - 16.57]

0.025

Hypertension

0.48 [0.12 - 2.00]

0.315

Renal failure

1.04 [0.11 - 10.04]

0.971

MAC/IV Sedation

0.62 [0.21 - 1.88]

0.401

377 378 379 380 381

0.355

0.126

3.83 [1.25 - 11.68]

0.019

Pneumonia

4.27 [0.39 - 46.61]

0.234

Reintubation Progressive renal insufficiency Acute renal failure

3.91 [0.40 - 37.86]

0.239

0.11 [0.002 - 5.96]

0.277

1.08 [0.03 - 45.00]

0.969

21.32 [2.07 - 219.46]

0.995

47.2 [9.27 - 240.34]

<0.001

33.46 [4.93 - 227.16]

0.010

24.22 [5.89 - 99.64]

<0.001

Bleeding

1.59 [0.33 - 7.67]

0.566

Sepsis

27.24 [2.97 - 249.69]

0.004

13.14 [2.88 - 59.94]

<0.001

Septic shock

10.09 [1.46 - 69.63]

0.019

11.43 [2.42 - 53.86]

0.002

EP

Cardiac arrest requiring CPR Myocardial infarction

AC C

Complications

0.380

Other

TE D

Anesthesia

Odds Ratio [95% CI]

RI PT

Race

Parsimonious Model

SC

Gender

Full Model

M AN U

375 376

3.89 [0.539 - 28.04] 0.178 Return to OR CHF: Congestive Heart Failure, MAC: Monitored Anesthesia Care, IV: Intravenous, CPR: Cardiopulmonary Resuscitation, OR: Operating Room, CI: Confidence Interval

ACCEPTED MANUSCRIPT

Table 5: Mortality by Age Group and functional status after excluding patients who underwent hybrid procedures

Age Group

Independent

Deaths (n)

%

Deaths (n)

70's

5/108

4.63%

8/381

80's

6/98

6.12%

5/276

90's

4/32

12.50%

1/56

Total

15/238

6.30%

14/713

2.10%

1.81%

M AN U

384

AC C

EP

TE D

385

%

RI PT

Dependent

SC

382 383

1.79%

1.96%

ACCEPTED MANUSCRIPT

386

Appendix A:

387

Concomitant open surgical procedures (number of patients) Ilio-femoral thromboendarterectomy (n= 57)

THROMBOENDARTECTMY SUPERFICIAL FEM ARTERY THROMBOENDARTECTMY ILIAC THROMBOENDARTECTMY ILIOFEMORAL THROMBOENDARTECTMY FEMORAL COMMON

Popliteal / Tibial Thromboendarterectomy (n=8)

35303

15

35305

3

35306

1

THROMBOENDARTECTMY POPLITEAL ARTERY THROMBOENDARTECTMY TIBIAL/ PERON ARTERY, INITIAL THROMBOENDARTECTMY TIBIAL/ PERON ARTERY, ADD

Iliofemoral and popliteal /tibial thromboendarterectomy (n = 8)

Combination of CPT codes from iliofemoral thromboendarterectomy and popliteal/tibial thromboendarterectomy above.

Lower extremity thrombectomy (n=18)

35875 35876 34201 34203 35879

SC

THROMBOENDARTECTMY FEMORAL DEEP

M AN U 9 1 7 5 1

TE D

CPT: Current Procedural Terminology

RI PT

20 18 8 31 25

EP

389

Frequency Description

35302 35351 35355 35371 35372

AC C

388

CPT codes

REMOVAL OF CLOT IN GRAFT REMOVAL OF CLOT IN GRAFT REMV ART CLOT ILIAC-POP,LEG INCIS REMV ART CLOT LOW LEG,LEG INCIS REVISE GRAFT/VEIN PATCH ANGIO