European Journal of Cardiovascular Medicine

Peripheral vascular disease (PVD), more precisely known as peripheral arterial disease (PAD), is a chronic, progressive atherosclerotic condition characterized by the narrowing or occlusion of peripheral arteries, primarily affecting the lower extremities. ^[1,2] It results from the gradual accumulation of atherosclerotic plaques within arterial walls, leading to reduced perfusion of the distal tissues. PAD is a significant global public health issue, with an increasing incidence and prevalence particularly in elderly individuals and populations burdened with comorbid conditions such as diabetes mellitus, hypertension, dyslipidemia, chronic kidney disease, and tobacco use. ^[1,3,4] The clinical implications of PAD range from intermittent claudication to critical limb ischemia, posing a substantial risk of limb loss and cardiovascular morbidity and mortality. ^[1]

The early detection and accurate prognostication of PAD are essential for improving long-term outcomes and preventing adverse events such as ulceration, gangrene, or amputation. Clinical assessment tools and non-invasive diagnostic modalities serve complementary roles in evaluating the severity of the disease and predicting its course. Among these, the Rutherford classification system, developed by Dr. Robert Rutherford and colleagues in 1986, provides a structured clinical staging of PAD based on patient symptoms and physical findings. ^[5] It categorizes PAD into seven stages, ranging from asymptomatic presentation (stage 0) to major tissue loss (stage 6), and remains widely used in both clinical and research settings to facilitate communication, guide treatment, and assess prognosis. However, this classification is subjective and may be influenced by patient interpretation of symptoms, coexisting conditions, and examiner variability.

Conversely, arterial Doppler ultrasonography offers an objective and reproducible diagnostic method that evaluates blood flow characteristics, arterial patency, and hemodynamic status. Parameters such as spectral waveform analysis, peak systolic velocity (PSV), and the ankle-brachial index (ABI) provide quantifiable insights into the extent and location of arterial obstruction. Doppler imaging is widely accessible, cost-effective, and safe, and it is especially useful for serial monitoring of disease progression and treatment response. Unlike Rutherford classification, which primarily reflects clinical impact, Doppler ultrasonography directly assesses vascular physiology and anatomical compromise.^[6-9]

Despite the routine use of both the Rutherford classification and Doppler ultrasonography in PAD evaluation, the correlation between clinical staging and Doppler-derived hemodynamic parameters is not consistently established. Studies have suggested variable concordance between the two, indicating that one method may not fully substitute the other in assessing disease severity or predicting outcomes. In some instances, patients with mild symptoms may exhibit significant Doppler abnormalities, and vice versa, reflecting the complex interplay between symptoms, collateral circulation, and individual pain perception. ^[3,8,9]

Therefore, an integrative assessment approach that includes both clinical classification and objective imaging is likely to enhance diagnostic precision and prognostic accuracy. Understanding how well the Rutherford classification aligns with Doppler findings in various stages of PAD is essential to validate their use in clinical algorithms, prioritize patients for intervention, and tailor management strategies. Moreover, comparing their predictive value for clinical outcomes such as progression to critical limb ischemia, need for revascularization, or limb loss can inform evidence-based practice and resource allocation.

Hence, the above study was conducted to compare the prognostic utility of the Rutherford classification and arterial Doppler ultrasound in patients diagnosed with peripheral vascular disease (PVD).

The study was conducted in the Department of General Surgery at Dr. D.Y. Patil Medical College Hospital & Research Institute, Kolhapur, from April 2023 to February 2025 after obtaining clearance from the Institutional Ethics Committee. Eligible patients who fulfilled the study criteria were enrolled after obtaining written informed consent. 75 participants were included in the study.

Inclusion criteria

Patients with objective evidence of impaired blood flow to the affected limb (e.g., reduced ankle-brachial index [ABI], weak or absent pulses, abnormal Doppler findings), Presence of tissue loss such as ischemic ulcers, gangrene, or necrosis, experiencing rest pain for more than two weeks, suggestive of critical limb ischemia.

Exclusion Criteria

Patients with deranged coagulation profiles (e.g., PT-INR abnormalities) or thrombocytopenia, with uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg), with severe comorbidities such as peripheral neuropathy or spinal stenosis, and individuals who refused to provide informed consent.

Detailed clinical examination was conducted, including history-taking and documentation of risk factors such as smoking, diabetes mellitus, hypertension, hyperlipidemia, and previous cardiovascular events. Demographic details and presenting complaints were recorded using a structured proforma. Each participant underwent classification using the Rutherford classification system, which stratifies PVD into stages 0 to 6, ranging from asymptomatic disease to major tissue loss. Clinical assessment included evaluation of claudication, rest pain, ulceration, and gangrene. Ankle and toe pressures were measured using Doppler ultrasound to support clinical staging. Simultaneously, arterial Doppler ultrasound of the lower limbs was performed using high-frequency linear transducers by trained sonographers. The examination included assessment of major arterial segments—femoral, popliteal, posterior tibial, and dorsalis pedis arteries—for flow characteristics, peak systolic velocities, turbulence, and presence of stenosis or occlusion.

ABI was calculated by dividing the systolic pressure at the ankle by the higher of the two brachial systolic pressures. ABI values <0.9 were considered diagnostic of PAD. Additionally, waveform morphology (triphasic, biphasic, monophasic) and post-exercise ABI changes were recorded for each limb. Data were collected at the time of admission and during inpatient stay. Follow-up assessments, if applicable, were conducted on outpatient basis at 1 and 3 months to observe changes in Rutherford classification and Doppler findings post-intervention or conservative management.

Data were entered into Google Sheets and analyzed using Microsoft Excel and SPSS v28 .0

Table 1: Age Category Distribution

The largest age groups were 40–50 years and 60 years and above, each comprising 20 individuals and contributing 26.67% to the total sample. The 30–40 age group followed closely with 19 participants (25.33%), while the 50–60 age group had the lowest representation with 16 participants (21.33%). The data indicate a fairly balanced distribution across age groups, with a slightly higher concentration in the 40–50 and 60+ age brackets. The total sample size was 75, accounting for 100% of the participants.

Table 2: Symptoms and Signs [n=75]

The most commonly reported symptom was claudication, observed in 37 patients (49.33%), followed by rest pain and weak pulses, both noted in 25 patients (33.33%). Ulceration and cold limbs were present in 18 patients each (24.00%), while gangrene and non-healing ulcers were reported in 15 patients (20.00%). The least frequent condition was tissue loss, affecting 12 patients (16.00%). These findings indicate that claudication was the predominant presenting complaint, while more severe signs like tissue loss and gangrene were less common, suggesting a range of clinical severity among the patients.

Table 3: Risk Factors for Peripheral Vascular Disease [ n=75 ]

The most prevalent risk factor was smoking, reported in 45 patients (60.0%), followed by hypertension in 40 patients (53.33%) and hyperlipidemia in 35 patients (46.67%). Diabetes was present in 30 individuals (40.0%), while obesity affected 25 patients (33.33%). Physical inactivity was noted in 20 patients (26.67%), and family history of vascular disease was reported by 15 patients (20.0%). These findings suggest a multifactorial risk profile, with modifiable lifestyle factors such as smoking, hypertension, and lipid levels being highly prevalent in this cohort.

Table 4: Rutherford Classification Stage

The most frequently observed stage was Stage 2, with 19 patients (25.33%), followed closely by Stage 1 with 17 patients (22.67%), and Stage 0 with 15 patients (20.0%), indicating a predominance of early-stage presentations. Stage 4 was observed in 8 participants (10.67%), while both Stages 3 and 5 were noted in 6 patients each (8.0%). The least common was Stage 6, affecting 4 patients (5.33%). This distribution reflects that the majority of patients presented with mild to moderate stages of peripheral arterial disease, with fewer cases progressing to severe stages.

Table 5: Arterial Doppler - Stenosis/Occlusion

A majority of 48 individuals (64.0%) showed no evidence of stenosis or occlusion, while 27 patients (36.0%) had positive findings of arterial narrowing or blockage. This indicates that over one-third of the study population exhibited significant vascular compromise on Doppler imaging, highlighting the importance of such diagnostic tools in evaluating peripheral arterial disease.

Table 6: Rutherford Classification Stage vs Arterial Doppler – Stenosis / Occlusion

In the early stages (0 to 2), the majority of patients showed no stenosis or occlusion: Stage 0 had 93.33% negative Doppler findings, Stage 1 had 82.35%, and Stage 2 had 73.68%. This suggests that vascular compromise is minimal or absent in the early stages.

In contrast, higher stages showed a marked increase in stenosis / occlusion. For instance, Stage 3 had 83.33% of patients with positive findings, Stage 4 had 62.5%, and Stage 5 had 66.67%. Stage 6, the most severe, showed 100% stenosis/occlusion on Doppler. This clear trend highlights a positive correlation between Rutherford stage severity and the presence of arterial stenosis or occlusion, emphasizing the progressive nature of peripheral arterial disease and the utility of Doppler ultrasound in assessing disease advancement.

There is a statistically significant association between Rutherford Classification Stage and the presence of arterial stenosis/occlusion (p = 0.0002).

Table 7: Rutherford Stage Classification Vs Arterial Doppler - Stenosis/Occlusion

Among those classified as Asymptomatic to Moderate, 42 out of 51 patients (82.35%) showed no stenosis or occlusion, while only 9 patients (17.65%) had positive findings. In contrast, within the Severe to Tissue Loss group, only 6 out of 24 patients (25.0%) showed no Doppler evidence of stenosis, whereas a substantial 75.0% (18 patients) had stenosis or occlusion detected.

This highlights a clear inverse relationship between disease severity and the absence of Doppler findings—as the Rutherford stage progresses, the likelihood of detecting stenosis or occlusion significantly increases, reinforcing the diagnostic value of arterial Doppler in assessing advanced peripheral arterial disease. The p-value for the association between Grouped Rutherford Stage Classification and Arterial Doppler - Stenosis/Occlusion is < 0.0001, indicating a highly significant association.

Table 8: Diagnostic Accuracy Metrics

The sensitivity is 75.0%, indicating that the Doppler test correctly identified 75% of patients who truly had significant disease. The specificity is 82.35%, meaning the test accurately ruled out disease in over 82% of patients without significant clinical signs.

The positive predictive value (PPV) is 66.67%, which reflects the likelihood that a patient with a positive Doppler result truly has significant disease. Conversely, the negative predictive value (NPV) is 87.5%, suggesting a high probability that patients with a negative result do not have advanced disease.

Overall, these values indicate that arterial Doppler has good diagnostic performance, particularly for ruling out significant peripheral arterial disease, as evidenced by the high NPV and specificity.

Age group:

In above study, the mean age of patients with peripheral arterial disease (PAD) was 50.67 years with a standard deviation of 13.71 years. The majority of participants were distributed fairly evenly across the 30–40, 40–50, and 60+ age groups, with each group contributing between 25% to 27% of the total sample, indicating a younger demographic compared to global studies. In contrast, the LIBERTY 360 study by Giannopoulos et al.^[10] (2021) reported a significantly older PAD cohort, with mean ages of 69.7 ± 10.0 years in claudicants and 70.3 ± 10.9 years in chronic limb-threatening ischemia (CLTI) groups. Similarly, McDermott et al.^[11] (2001) also featured PAD patients predominantly aged above 65 years, reflecting the disease's common association with advancing age in Western populations. The younger age trend seen in our population may be attributed to the high burden of modifiable risk factors such as smoking and diabetes occurring earlier in life in the Indian subcontinent. It also raises the possibility of differences in health-seeking behavior, environmental exposures, or genetic predisposition. These findings highlight the necessity for early screening and lifestyle intervention programs tailored for younger age groups in developing countries where PAD may present earlier and with unique risk profiles.

Risk Factors:

In above study, the predominant risk factors for peripheral arterial disease (PAD) were smoking (60%), hypertension (53.33%), hyperlipidemia (46.67%), diabetes mellitus (40%), obesity (33.33%), physical inactivity (26.67%), and a family history of vascular disease (20%). These findings underscore the significant role of modifiable cardiovascular risk factors in the development of PAD.

Comparatively, Wattanakit et al.^[12] (2005) in the Atherosclerosis Risk in Communities (ARIC) study found that among individuals with diabetes, traditional risk factors like smoking, hypertension, and hyperlipidemia significantly increased the incidence of PAD. Joosten et al.^[13] (2012) demonstrated that smoking, hypertension, hypercholesterolemia, and type 2 diabetes accounted for the majority of PAD risk in men, with a multivariable-adjusted hazard ratio of 2.06 for each additional risk factor.

Criqui et al. ^[14,15] (1997) emphasized that smoking is the most powerful independent predictor of PAD, particularly in men. The National Health and Nutrition Examination Survey (NHANES) highlighted that an aggregate set of risk factors, including diabetes mellitus, chronic kidney disease, hypertension, and smoking, significantly increased the likelihood of prevalent PAD.

Ridker et al.^[16] (2001) identified novel risk factors such as elevated levels of C-reactive protein and homocysteine as predictors of systemic atherosclerosis, which includes PAD.

These cross-study observations confirm that smoking remains a critical risk factor globally, but the presence of other factors like diabetes, hypertension, and physical inactivity also play significant roles in the development of PAD. The findings emphasize the importance of comprehensive risk factor management, including smoking cessation programs, blood pressure and lipid control, diabetes management, and promotion of physical activity, to prevent and manage PAD effectively.

Rutherford Classification:

Most patients were classified within Rutherford Stages 1 (22.67%) and 2 (25.33%), indicating that the majority presented with mild to moderate claudication. Fewer patients were in advanced stages such as Stage 4 (10.67%), Stage 5 (8%), and Stage 6 (5.33%), reflecting the clinical spectrum of PAD severity. Comparatively, in the LIBERTY 360 study by Giannopoulos et al.^[10] (2021), a large sample of 1189 patients was stratified into RC 2–3 (n=500), RC 4–5 (n=589), and RC 6 (n=100). The distribution in LIBERTY 360 shows a much higher proportion of patients with advanced chronic limb-threatening ischemia (CLTI), with over 58% of their patients in RC 4–6. This contrasts with our cohort, where earlier stages predominated, suggesting either earlier detection, differences in healthcare-seeking behavior, or referral bias in a tertiary care setting.

Van der Heijden et al.^[17] (2023), in a large observational study validating clinician-reported Rutherford scores, reported high inter-observer agreement, reinforcing the reliability of Rutherford classification in routine practice. This supports its continued use in both clinical and research settings. The classification's validity as a predictor of disease progression and intervention outcomes was also emphasized in the TASC II guidelines and further reaffirmed in the 2017 ESC Guidelines (Aboyans et al.^[18], 2018), which recommend Rutherford staging as a core clinical assessment tool for PAD severity.

McDermott et al.^[11] (2001) and Criqui et al.^[14] emphasized that many PAD patients fall within the early Rutherford stages and may still have significant functional impairment despite the absence of tissue loss, which aligns with our finding that a considerable proportion of patients reported claudication and rest pain without ulceration.

Furthermore, the Endovascular Revascularization Studies like BASIL and CLEVER trials used Rutherford categories to stratify outcomes and demonstrated that advanced stages (RC 5–6) were associated with higher amputation and mortality risks. Hence, our study's relatively lower proportion of patients in advanced Rutherford stages may also correlate with better limb salvage and survival outcomes, although longer-term follow-up would be needed to confirm this.

Overall, the Rutherford classification remains a clinically meaningful and externally validated staging system, and our data conform to global trends showing a gradual rise in stage prevalence with worsening ischemia. Above study reinforces its practicality in early disease identification, especially in regions with high-risk but younger populations.

Doppler studies:

36% of patients had arterial Doppler findings indicative of stenosis or occlusion, while 64% had no detectable vascular obstruction. This finding suggests that while a majority were in earlier stages of PAD, over one-third had progressed to a point where structural arterial changes were present. Doppler ultrasonography, as used in our study, remains a frontline tool for the non-invasive evaluation of PAD. According to Collins et al.^[19] (2007) in a systematic review of diagnostic imaging for PAD, duplex ultrasonography (DUS) had a sensitivity range of 80–98% and specificity of 89–99%, reinforcing its utility as a reliable modality, especially for initial screening.

In the LIBERTY 360 study, imaging was primarily angiographic, yet the association between higher Rutherford stages and more severe occlusions parallels our finding where advanced Rutherford stages had greater Doppler-confirmed stenosis rates. ^[10] Pollak et al.^[20] (2012) emphasized the value of DUS in identifying hemodynamically significant lesions, especially in resource-limited settings or in patients unsuitable for contrast-based imaging. Our results correlate well with these standards, as Doppler-confirmed occlusion increased proportionally with clinical severity.

Additionally, the 2017 ESC Guidelines on PAD (Aboyans et al.(64)) reaffirmed that Doppler ultrasonography is a first-line imaging modality due to its cost-effectiveness, accuracy, and safety profile. Similarly, Potier et al. ^[22] (2011) discussed the importance of interpreting Doppler indices carefully in diabetic patients, where vascular calcification can lead to falsely elevated ABI or missed occlusions—an important consideration for our 40% diabetic cohort.

In conclusion, our findings not only validate the role of arterial Doppler as a diagnostic cornerstone but also illustrate its strong correlation with clinical staging, reinforcing its role in PAD management and early detection, particularly in moderate-to-severe disease.

Rutherford stage Vs Doppler:

In above study, we found a strong, progressive correlation between increasing Rutherford classification stages and the presence of stenosis or occlusion on arterial Doppler. Patients in Rutherford Stage 0 had only 6.67% Doppler positivity, whereas those in Stage 6 had 100% positivity, clearly illustrating that clinical severity strongly aligned with Doppler-confirmed arterial pathology. This trend is consistent with findings from Buril et al.^[23] (2024), who showed that the resistance index on Doppler ultrasound increases proportionally with Rutherford stage, indicating greater peripheral resistance and advancing ischemia. Similarly, Tanno et al. ^[24] (2016) introduced the Ankle Hemodynamic Index (AHI), which was found to correlate significantly with Rutherford categories, providing a hemodynamic basis for clinical staging.

Collins et al. ^[19] (2007), in a systematic review, highlighted the high diagnostic performance of duplex Doppler, with sensitivities up to 98%, making it an ideal non-invasive tool to support clinical staging systems like Rutherford. Pollak et al.^[20] (2012) echoed this, stating that modern Doppler technology provides both anatomical and flow-based assessments that are especially reliable when correlated with clinical presentation.

Potier et al.^[22] (2011) discussed the limitations of ABI in diabetic patients, where medial arterial calcification may lead to falsely elevated values. In such cases, Doppler waveform analysis becomes even more critical in confirming true arterial compromise. This is highly relevant to our cohort, where 40% of patients were diabetic.

Wattanakit et al.^[12] (2005) Joosten et al.^[13] (2012) and emphasized that traditional risk factors like smoking, hypertension, and diabetes not only increase PAD risk but also accelerate disease progression, which corresponds to higher Rutherford staging and more frequent Doppler-detectable lesions.

Diagnostic performance of Rutherford staging:

In above study, when Rutherford stages were dichotomized into “Asymptomatic to Moderate” (Stages 0–3) and “Severe to Tissue Loss” (Stages 4–6), a striking difference in Doppler-confirmed vascular pathology emerged: only 17.65% of patients in the former group showed stenosis or occlusion, whereas a substantial 75% in the latter group had positive Doppler findings. This reinforces the earlier table’s trend and highlights the diagnostic power of arterial Doppler in detecting disease progression. Supporting this, Buril et al.^[23] (2024) and Tanno et al.^[24] (2016) found statistically significant increases in Doppler resistance indices and hemodynamic parameters with higher Rutherford stages. The diagnostic metrics derived from our study further underscore this value—sensitivity of 75%, specificity of 82.35%, positive predictive value (PPV) of 66.67%, and a notably high negative predictive value (NPV) of 87.5%. These values are consistent with ranges reported in international reviews, such as Collins et al.^[19] (2007), who documented DUS sensitivity between 80–98% and specificity from 89–99%, and Pollak et al.^[20] (2012), who emphasized Doppler’s high accuracy when paired with clinical evaluation. The high NPV in our findings is especially relevant for excluding advanced PAD in asymptomatic or early-stage cases, affirming Doppler’s utility as a reliable screening tool. The correlation seen in above conducted study between worsening Rutherford categories and increased Doppler positivity, coupled with robust diagnostic accuracy, mirrors findings from Sakaguchi et al.^[25] (2018) and Giannopoulos et al.^[10] (2021), who associated advanced stages with occlusive disease and worse prognoses. Collectively, these findings validate the effectiveness of combining Rutherford staging with arterial Doppler as a comprehensive, non-invasive diagnostic strategy to accurately assess PAD severity and direct appropriate intervention.

From the above study it can be concluded that Doppler ultrasound proved to be a valuable tool for confirming arterial occlusion and grading severity, aligning well with Rutherford clinical staging. A statistically significant correlation (p = 0.0002) was found between Rutherford Classification Stage and Doppler-confirmed stenosis or occlusion. Patients in higher Rutherford stages (5 and 6) had universal Doppler-detected arterial occlusions, indicating advanced disease. The findings underscore the need for early screening and preventive interventions in at-risk populations, especially younger adults in the Indian context. Doppler ultrasonography should be integrated into routine PAD assessment due to its high sensitivity, non-invasive nature, and compatibility with clinical staging.

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