A comparison of revascularization methods for peripheral arterial disease in diabetics: Changing trends in lower extremity revascularization from 2008 to 2014

Abstract

Objectives

This study examined the current demographic and outcome trends regarding endovascular and open revascularization for people with diabetes.

Methods

The National Inpatient Sample database was utilized to identify diabetic patients who underwent lower extremity revascularization and amputation procedures between 2008 and 2014. International Classification of Diseases 9th edition codes were used to identify the procedures, diagnoses, and comorbidities.

Results

We identified 38,143 diabetic patients who underwent endovascular revascularization and 25,415 who underwent open revascularization between 2008 and 2014. The number of endovascular and open revascularization procedures decreased steadily by 17.5% and 12.43% during the study period, respectively. The total charges for the endovascular procedure were greater than the open procedure ($98,761 vs. $80,782, p ≤ 0.001) despite similar median length of stay (5 days (inner quartile range (IQR) = 1–10) vs. 5 days (IQR = 3–10), p ≤ 0.001). Compared to open, the in-patient amputation rate for endovascular patients has been increasing faster for both minor (11.75% vs. 0.37%) and major amputations (3.08% vs. 0.19%). Although the post-procedure amputation rates between endovascular and open procedures were increased for endovascular patients (odds ratio [OR] = 1.71, confidence interval [CI] = 1.35–2.18, p ≤ 0.001) in 2008, by 2014 the risk of major amputation was doubled in endovascular patients (OR = 2.88, CI = 2.27–3.64, p ≤ 0.001). African Americans were more likely to undergo minor amputation than Whites (p ≤ 0.001). Lastly, diabetic patients with uncontrolled diabetes, systemic infection, weight loss, congestive heart failure, gangrene, and end-stage renal disease were more likely to undergo endovascular repair.

Conclusions

As more medically complex patients undergo endovascular revascularization, endovascular revascularization for diabetic patients is becoming associated with higher total cost despite similar length of stay, minor amputation, and major amputation rates. Further studies are needed to continuously evaluate the post-procedural outcomes and cost effectiveness of this trend.

Keywords

Trends in healthcare endovascular vs. open

Introduction

Chronic limb-threatening ischemia (CLTI) is a classification of peripheral arterial disease (PAD) that is further characterized by the presence of rest pain, ischemic ulcers, or tissue loss. The incidence of CLTI in the United States has been estimated to be between 500 and 1000 per million persons per year and is rising worldwide secondary to an aging population, increasing rates of metabolic syndrome, diabetes mellitus (DM), and smoking.^1–3 CLTI is associated with significant disability, morbidity, and mortality. It has been estimated that after being diagnosed with CLTI for one year that up to 30% of patients will have an amputation and 25% of patients will die.^4,5

DM is associated with the development of PAD, and the risk increases with duration of disease. Patients with diabetes are widely recognized to be at higher risk for amputation and the rapidly increasing prevalence of DM worldwide is concerning particularly due to concern of its impact on the incidence of major lower extremity amputations (MLEA).^1,3 The number of people living with the loss of a limb is expected to be more than double between 2005 and 2050. The majority of this increase in amputations is the result of an increased incidence of PAD, with totals projected to increase from less than 1 million in 2005 to 2.3 million in 2050.⁶ The Bypass versus Angioplasty in Severe Ischemia of the Leg (BASIL) trial remains the only randomized controlled trial (RCT) to compare a bypass-first with an endovascular-first revascularization strategy for severe limb ischemia due to infra-inguinal arterial occlusive disease; however, this study did not specifically address the effectiveness of treatment for those with PAD and DM with regard to the rate of amputation.⁷

Through this study we sought to study the current demographic and outcome trends in endovascular and open revascularization for lower extremity PAD in people with diabetes.

Methods

Data collection

We utilized the NIS (The Nationwide Inpatient Sample) of The Healthcare Cost and Utilization Project to select for patients who were admitted with diabetes between 2008 and 2014. The International Classification of Diseases 9th edition Clinical Modification (ICD-9-CM) diagnosis and procedure codes, and the Agency for Healthcare Research and Quality (AHRQ) comorbidity measures were all utilized to determine the patients’ comorbidities, demographic information, and outcomes specifically major or minor lower extremity amputation. The data set was arranged into categorical, continuous, or ordinal variables. The specific codes used for each of these parameters are provided in Supplemental Table 1. We focused on diabetic adult inpatients who admitted with procedure of endovascular revascularization. In order to assure we track the specific population with lower extremity patients, we applied the diagnosis codes 44021-44024, together with the revascularization procedure codes. In such, 38,143 individuals who underwent endovascular revascularization and 25,415 who underwent open revascularization, at age of 18 and older, who did not die in hospital were selected as case candidates.

Statistical analysis

All analyses are prepared by statistical software SPSS and R, database-related work was done by SQL under “sqldf” and R package. Charlson comorbidity index and Elixhauser comorbidity index are calculated by R package “comorbidity”, weighted comorbidity are applied to each patient. Cochran Armitage Test for comparing the trend of endovascular and open revascularization, as well as the comorbidities, through 2008–2014 were performed under R package “DescTools”. Figures and tables were prepared by Microsoft Excel. p-Value was calculated using the Wilcoxon signed-rank test for difference of numerical variables, the chi-square test for binary variables, and the chi-square test for independence for multilevel variables, with p < 0.05 deemed to be significant. All service charges have been adjusted to consumer price of 2019 by CPI inpatient hospital services annual rate (Supplemental Table 1).

Results

Between 2008 and 2014, 63,558 diabetic patients over the age of 18 who survived hospitalization underwent revascularization, 38,143 of which was endovascular and 25,415 of which was open (Table 1).

Table 1.

Demographics.

Characteristics	Endovascular (n = 38,143)	Open (n = 25,415)	p-Value
Age – yrs (median IQR)	69 (61–77)	67 (60–75)	<0.001
Women (%)	16,247 (42.6)	9588 (37.7)	<0.001
Race – no. (%)			<0.001
White	20,559 (59.2)	15,830 (69.2)
Black	6823 (19.7)	3980 (17.4)
Hispanic	4960 (14.3)	1993 (8.7)
Asian	592 (1.7)	317 (1.4)
Native American	448 (1.3)	149 (0.7)
Other	1322 (3.8)	601 (2.6)
Total charges – USD (median IQR)†	98,671 (61,835.5–16,0851.5)	80,782 (48,993.75–141,119.00)	<0.001
Length of stay – days (median IQR)	5 (1–10)	5 (3–10)	<0.001
Comorbidities – no. (%)
Gangrene	14,077 (36.9)	7342 (28.9)	<0.001
Uncontrolled diabetes	17,484 (45.8)	8884 (35.0)	<0.001
Obesity	4665 (12.2)	3304 (13.0)	<0.001
Osteomyelitis	5858 (15.4)	1953 (7.7)	<0.001
Systemic infection	2640 (6.9)	1211 (4.8)	<0.001
End-stage renal disease	15,245 (40.0)	6476 (25.5)	<0.001
Congestive heart failure	8373 (22.0)	4249 (16.7)	<0.001
Foot ulcer	15,038 (39.4)	7570 (29.8)	<0.001
Hypertension	31,579 (82.8)	21,302 (83.8)	<0.001
Weight loss	1775 (4.7)	907 (3.6)	<0.001
Anemia	11,000 (28.8)	5984 (23.5)	<0.001
Paralysis	1021 (2.7)	481 (1.9)	<0.001
Drug abuse	349 (0.9)	246 (1.0)	0.529
Age – yrs (%)			<0.001
(18, 40)	296 (0.8)	158 (0.6)
(40, 50)	2015 (5.3)	1439 (5.7)
(50, 60)	7216 (18.9)	5370 (21.1)
(60, 70)	11,736 (30.8)	8620 (33.9)
(70, 80)	10,718 (28.1)	6888 (27.1)
(80+)	6162 (16.2)	2940 (11.6)
Median household income based on zip code – no. (%)			<0.001
0–25th percentile	13,113 (35.2)	7871 (31.6)
26th to 50th percentile	9716 (26.1)	6991 (28.1)
51st to 75th percentile	8108 (21.7)	5840 (23.4)
76th to 100th percentile	6360 (17.1)	4213 (16.9)
Patient insurance – no. (%)			<0.001
Medicare	27,603 (72.4)	16,957 (66.8)
Medicaid	3125 (8.2)	2040 (8.0)
Private	5910 (15.5)	5348 (21.1)
Self-pay	774 (2.0)	508 (2.0)
No charge	100 (0.3)	94 (0.4)
Other	593 (1.6)	428 (1.7)
Hospital bed size – no. (%)			<0.001
Small	4130 (10.9)	2712 (10.7)
Medium	9628 (25.4)	5684 (22.5)
Large	24,187 (63.7)	16,899 (66.8)
Geographic area – no. (%)			<0.001
Rural	2268 (5.9)	1663 (6.6)
Metropolitan nonteaching	14,601 (38.5)	9317 (36.8)
Metropolitan teaching	21,076 (55.5)	14,315 (56.6)
Hospital type – no. (%)			<0.001
Government, nonfederal	3233 (8.5)	2180 (8.6)
Private, not-profit	27,515 (72.5)	19,688 (77.8)
Private, invest-own	7197 (19.0)	3427 (13.5)

IQR: inter quartile range.

†USD – United States Dollar, charges have been adjusted to consumer price of 2019 by CPI inpatient hospital services annual rate.

Although there was no difference in age between the two cohorts, the endovascular group was more likely to be female (42.6% vs. 37.7%, p ≤ 0.001) and of a minority population (p ≤ 0.001) including African American (19.7% vs. 17.4%) or Hispanic (14.3% vs. 8.7%). Patients with diabetes undergoing open revascularization had higher rates of foot ulcers (39.4% vs. 29.8%, p ≤ 0.001) and hypertension (83.8% vs. 82.8%, p ≤ 0.001). In comparison, the endovascular revascularization cohort had increased overall comorbidities including gangrene (36.9% vs. 28.9% p ≤ 0.001), uncontrolled diabetes (45.8% vs. 35.0%, p ≤ 0.001), osteomyelitis (15.4% vs. 7.7%, p ≤ 0.001), systemic infection (6.9% vs. 4.8%, p ≤ 0.001), end-stage renal disease (ESRD) (40.0% vs. 25.5%, p ≤ 0.001), and congestive heart failure (22.0% vs. 16.7%, p ≤ 0.001). They also had an increased frequency of anemia (28.8% vs. 23.5%, p ≤ 0.001), paralysis (2.7% vs. 1.9%, p ≤ 0.001), weight loss (4.7% vs. 3.6%, p ≤ 0.001). Patients in the endovascular group tended to be in the lowest income quartile (35.2% vs. 31.6%, p ≤ 0.001) and utilize Medicare (72.4% vs. 66.8%, p ≤ 0.001), while the open group had higher rates of private insurance (21.1% vs. 15.5%, p ≤ 0.001). Additionally, the total charges for the endovascular procedure were greater than the open procedure ($98,671 vs. $80,782, p ≤ 0.001) despite a similar median length of stay (LOS) (5 days (median inner quartile range (IQR) = 1–10) vs. 5 days (median IQR = 3–10), p ≤ 0.001). Charlson and Elixhauser comorbidity indices were also performed. For the Charlson index, the Endovascular cohort had more comorbid conditions compared to the open group when looking at median (IQR) (4(3–5) vs. 3(2–5), p ≤ 0.001). This same trend of the endovascular group having more comorbidities was also seen using the Elixhauser comborbidity index median (IQR) (5(2–14) vs. 5(2–11), p ≤ 0.001) (Supplemental Table 2).

Between 2008 and 2014, the total number of diabetic patients that required endovascular and open revascularization decreased from 6218 to 5132 and 3862 to 3382 per year, respectively. Patients undergoing endovascular revascularization tended to have higher and increasing rates of anemia, systemic infection, congestive heart failure, and osteomyelitis (Figure 1).

Figure 1.

Comorbidities in diabetes mellitus patients undergoing revascularization from 2008 to 2014. Each graph depicts the trend in various ICD-9 variables (as defined in Supplemental Table 1) from 2008 to 2014 among inpatients undergoing either open or endovascular revascularization including (a) obesity, (b) weight loss, (c) anemia, (d) gangrene, (e) foot ulcer, (f) systemic infection, (g) uncontrolled diabetes mellitus, (h) neurological disorder, (i) congestive heart failure, (j) end-stage renal disease, (k) hypertension, and (l) osteomyelitis.

Indeed, patients with gangrene tended to undergo open revascularization in 2008, but by 2014 were more likely to have an endovascular procedure. The total number and percent of major amputations and minor amputations in individuals undergoing open revascularization did not substantially increase between 2008 and 2014 (Figure 2).

Figure 2.

Major amputations in endovascular vs. open revascularization patients during 2008–2014. Major amputations (top) and minor amputations (bottom). The blue line represents the endovascular cohort and the orange line represents the open cohort.

However, between 2008 (odds ratio [OR] = 1.71, confidence interval [CI] = 1.35–2.18, p ≤ 0.001) and 2014 (OR = 2.88, CI = 2.27–3.64, p ≤ 0.001) there was a nearly double increased risk for major amputation in endovascular patients. Additionally, the absolute number (252 to 366) of major amputation and minor amputation (718 to 1196) in endovascular patients increased substantially between 2008 and 2014. Furthermore, patients undergoing endovascular procedures in 2008 had a lower risk of minor amputation but by 2014 were much more likely to experience a minor amputation than those undergoing an open procedure (OR = 0.89 vs. 2.01). The percentage of minor amputations in individuals undergoing open revascularization did not significantly change, while the total number decreased from 689 to 614. Patients in the lowest income quartile also experienced the highest minor amputation rates for endovascular (31.9%) and open procedures (24.4%). This trend was also seen for major amputation. Moreover, the lowest income quartile was noted to have higher risk of both minor and major amputations in both endovascular and open revascularization groups as highlighted in Figure 3. Furthermore, African Americans and Hispanics had higher rates of minor amputation than Whites when undergoing both endovascular procedures (African Americans (24.0% vs. 16.4%), Hispanics (11.2% vs. 8.3%), Whites (59.5% vs. 70.7%), p ≤ 0.001) and open procedures (African Americans (24.3% vs. 18.7%), Hispanics (15.8% vs. 14.0%), Whites (54.1% vs. 60.3%), p ≤ 0.001). Although race was not a significant determining factor for major amputation in either endovascular (African Americans (10.8% vs. 8.6%), Hispanics (12.3% vs. 15.0%), Whites (71.7% vs. 72.8%), p ≥ 0.05) or open procedures (African Americans (12.5% vs. 8.2%), Hispanics (16.4% vs. 21.5%), Whites (65.5% vs. 65.9%), p ≥ 0.05).

Figure 3.

Household income and race for endovascular vs. open revascularization patients undergoing minor and major amputation. Each graph depicts either the race or household income for each cohort and is further subdivided by amputation status from 2008 to 2014 among inpatients undergoing either open or endovascular revascularization including (a) race and minor amputation, (b) race and major amputation, (c) income and minor amputation, and (d) income and major amputation.

Discussion

DM is the seventh leading cause of death and affects 34.2 million people in the United States.⁸ The prevalence and incidence of diabetes have been increasing and this disease will continue to be one of the defining health challenges of a generation. Individuals with diabetes suffer from an increased risk and accelerated course of PAD which leads to ischemic events and a decline in functional status.⁹ Many individuals often require revascularization to treat PAD. It is important to explore the outcomes of treating lower extremity PAD in diabetics with endovascular and open revascularization in order to optimize care for this ever growing population.

Within the NIS database, a greater number of individuals underwent endovascular revascularization (38,143) rather than open (25,415) during the study period. Patients undergoing endovascular revascularization incurred higher total charges ($98,761 vs. $80,782, p ≤ 0.001) despite similar median LOS (5 days (IQR = 1–10) vs. 5 days (IQR = 3–10), p ≤ 0.001). These results are in contradiction with previous publications which indicated that advanced endovascular devices and therapy confirm a shorter lengths of hospitalization in comparison to open and that this reduction in LOS lowers overall cost.¹⁰ However, this could be confounded by the fact that our study population was confined to the admitted patient population and did not consider the ones who underwent outpatient endovascular procedures.

Notably, the endovascular group suffers higher rates of overall comorbidities in comparison to the open group including congestive heart failure, ESRD, anemia, and systemic infection. There is a well-documented relationship between diabetes and increased incidence rates of congestive heart failure which was further confirmed by our analysis.¹¹ The patients with diabetes also suffer more frequent and severe infections due to elevated glucose levels interfering with the antioxidant system and neutrophil function in the immune system.¹² Additionally, patients undergoing the endovascular procedure had higher rates of uncontrolled diabetes, which often progresses to sensory neuropathy and allows for the development of foot ulcers.¹³ Breakdown of the protective skin barrier consequently promotes and compounds their inherent risk for infection and offers an explanation for the increase in osteomyelitis observed in this group. Furthermore, diabetes is a leading risk factor for the development of ESDR.¹⁴ Anemia often develops secondary to poor renal function due to the kidney’s inability to generate erythropoietin.¹⁵

Diabetes leads to triple the risk for PAD which is subsequently correlated with elevated rates of lower extremity amputation.¹⁶ There was no change in the rates of either major or minor amputations in patients who underwent open revascularization between 2008 and 2014. However, there was an increased total number and risk for major amputations associated with endovascular revascularization between 2008 (252, OR =1.71) and 2014 (366, OR = 2.88). This contradicts some previous research which has suggested endovascular revascularization to have lower rates of morbidity and mortality.¹⁶ Additionally, minor amputations in the endovascular group substantially increased during this time (718 vs. 1196) along with an increased risk (OR = 0.89 vs. 2.01). These results revealed endovascular patients were experiencing a greater number of overall amputations in comparison to their open revascularization counterparts. Schuyler Jones et al. analyzed seven studies in PAD treatment effectiveness also concluded endovascular patients had increased rates of amputation.¹⁷ These results suggest that either the endovascular procedure is associated with adverse results or as previously stated, may be due to increased comorbidities in the endovascular group which predisposes them to poorer outcomes. Surgeons may be opting for the perceived safety of endovascular technique in patients with high comorbidity indices, which in turn will lead to poorer outcomes given that these are the sickest patients. Specifically, elevated rates of uncontrolled diabetes and consequent elevated glucose levels correlate to a heightened risk for amputation and offer an explanation for the increase of major and minor amputations.¹⁸ Looking at the BASIL study comparing amputation-free survival of bypass vs. angioplasty found no difference between the short-term amputation rates following the two treatments.¹⁹

The highest rates of major amputations were observed in the lowest income quartile of the endovascular group. Endovascular patients were more likely to be in the lowest income quartile, utilize Medicare, and be of a minority population. Furthermore, there was an overall increased risk of minor amputation for both endovascular and open patients in the lowest income quartile in comparison to the highest quartile. African Americans were also more likely to undergo a minor amputation during their hospitalization. One hypothesis for this increased incidence of amputations in minorities is that African Americans are receiving less aggressive preventative care in comparison to Caucasians previous to amputation. Although both races were comparable in age and prevalence of diabetes, African American amputees were more likely to be of lower socioeconomic status and less likely to have undergone revascularization or wound debridement prior to amputation resulting in two to four times the rate of amputation.²⁰ This could be due to limited healthcare access, biological differences in disease progression, or a delay in seeking medical care during later stages of disease.²⁰

There has been an overall increase in the number of diabetics undergoing endovascular, while the amount undergoing open revascularization has remained steady between 2008 and 2014 (see Figure 2). However, the population undergoing endovascular treatment has gotten sicker during this time period from several additional complications that clinicians should be aware of including systemic infection, uncontrolled diabetes, and chronic heart failure. The scientific community must continue to improve treatment plans to minimize negative outcomes for these patients.

The limitations of this study are mostly due to the NIS database. The NIS database does not include any procedures performed in the outpatient setting. Additionally, the quality of the database relies on proper physician coding of procedures and diagnoses. If a procedure or diagnosis is not coded correctly, this introduces one potential source of error. The NIS database also does not have follow-up information and only shows the clinical course of a single admission which may be more representative of acute processes as opposed to the longitudinal outcomes of patients. Furthermore, the ICD-9 coding system has its own limitations and is not as specific as the ICD-10 system. However, the ICD-10 system is not usable with data in the NIS database before 2014. With these limitations in consideration, the NIS database still provides the most comprehensive publicly available database with over 80 million patient encounters. Using the database for trend analysis, as opposed to specific outcomes, helps to mitigate these limitations.

Conclusion

The prevalence of DM and CLTI are continuing to increase; however, more patients are being treated by endovascular procedures as opposed to open. As such, it is necessary to exam the trends of these greatly impactful aspects of healthcare to determine the impact of the shift in procedure choice. According to the NIS database between 2008 and 2014, endovascular intervention is associated with higher total charges despite similar LOS compared to open intervention, and both minor and MLEA rates. Despite the increased number of endovascular interventions, the major and minor amputation rates for a single admission period continue to rise. The higher rate of amputation after endovascular intervention might be related to advanced ischemia or poor clinical condition of patients, making them unfit for open procedures. Further studies are needed to continuously evaluate the post-procedural outcomes and cost effectiveness of this trend.

Supplemental Material

sj-pdf-1-vas-10.1177_17085381211012564 - Supplemental material for A comparison of revascularization methods for peripheral arterial disease in diabetics: Changing trends in lower extremity revascularization from 2008 to 2014

Supplemental material, sj-pdf-1-vas-10.1177_17085381211012564 for A comparison of revascularization methods for peripheral arterial disease in diabetics: Changing trends in lower extremity revascularization from 2008 to 2014 by Qiong Qiu, Stavros Stefanopoulos, Daniela Kaissieh, Meghan Wandtke, Gang Ren, Mohamed Osman, Munier Nazzal and Ayman Ahmed in Vascular

Footnotes

Authors’ note

The data used in this analysis was acquired by the AHRQ and complies entirely with their Data Use Agreement in order to protect the identity of patients and their data. This includes not reporting results with n less than 10 individuals. No IRB approval was necessary for this project as the data is already deidentified by the AHRQ.

Acknowledgments

This work was presented at the American College of Surgeons Clinical Congress 2020, Virtually, 3–7 October 2020.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Stavros Stefanopoulos

Supplemental material

Supplemental material for this article is available online.

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