[version 1; peer review: 1 not approved]
No competing interests were disclosed.
One of the serious cardiovascular conditions is peripheral arterial disease; in which distinctive feature is diminished blood supply towards the lower extremities, frequently because of atherosclerotic occlusive disease.
We will compare arterial Doppler with digital subtraction angiography in peripheral lower limb occlusive arterial sickness; to determine Peripheral Arterial Disease along with its location and stenosis severity on Duplex Ultra-Sonography and Digital Subtraction Angiography; and to determine the segment-to-segment agreement of the arterial tree within Duplex Ultra-Sonography and Digital Subtraction Angiography.
This will encourage the participants for periodic investigation and proper use of medications which will improve hospital/facility outcome. It will be helpful for older individuals how are more susceptible to peripheral artery disease. A fair accurate treatment options will be given to patients.
Findings will only be applicable to our organization because the study will be done at one tertiary care hospital, limiting their external validity and generalizability.
Peripheral arterial disease (PAD) is a major cardiovascular condition, presenting with deficient blood supply affecting the lower extremities, frequently as a result of atherosclerotic occlusive disease.
Approximately 10% to 25% of people over the age of 55 have PAD in their lower limbs, and the frequency rises with age. The most prominent risk factors for peripheral arterial disease include being over the age of 50 years, experiencing diabetic complications, engaging in nicotine consumption, and having dyslipidemia.
Patients with PAD might show symptoms or might not. The size and location of the affected artery, the extent of collateral circulation as well as the metabolic demands placed on the ischemic tissue during exercise, all of this influence the presence of symptoms.
Digital subtraction angiography represents a minimally invasive technique that serves as the standard approach for percutaneous revascularization therapy in non-responsive patients with medical therapy. But while working with people who have destructive lower limb ischemia, for appropriate therapy, re-planning, and evaluation of subsequent treatment outcomes and consequences, proper interpretation of diagnostic DSA findings is essential.
DUS is usually the first investigation of choice, owing to its easy availability, low cost, and the non-invasive nature of the procedure. However, it does not come without its limitations. DUS is largely operator dependent; hence the user’s level of expertise can affect its quality. Moreover, deep-seated arteries, such as the infragenicular arteries in the lower limbs may prove difficult to assess, particularly if edema is present.
Even though digital subtraction arteriography has been around for a while, duplex ultrasonography is still a common imaging method utilized in most vascular centers.
There are other causes of PAD; The main factor causing PAD is atherosclerosis. Stroke and myocardial infarction risk are decreased by medical treatment that targets atherosclerotic risk factors which are the main factors that lead to mortality in people with PAD.
Maximum systolic velocity at the location of a blockage can be used to measure variations in a cross-sectional area of the arterial lumen.
Management strategies differ for patients with lower extremities arterial illnesses. While Angioplasty is frequently used to treat individuals with ischemia that poses a risk to their limbs, Amputation or revascularization via surgery, Conservative management is usually used for temporary claudication.
The appropriate line of action is determined by the disease’s intensity, this may call for pairing therapies. Hence, individuals with limb-threatening ischemia need to be thoroughly evaluated. A proper treatment plan for each patient can be created with the help of knowledge about agreement between two different treatment modes, invasive and non-invasive.
To evaluate risk factors for Peripheral Occlusive Arterial Disorder. To assess the presence, location, and severity of stenosis in Peripheral Arterial Disease using Duplex Ultrasonography. To assess the presence, location, and severity of stenosis in Peripheral Arterial Disease using Digital Subtraction Angiography. To determine the segment-to-segment agreement of the arterial tree between Digital Subtraction Angiography and Duplex Ultrasonography.
Formula:
Individuals who have a clinical suspicion of having peripheral artery disease. Patients of age over the age of 18. Patients ready to take part in the investigation. Giving the history of chronic peripheral vascular disease.
Pregnant woman Patients with blood disorders Those who are vulnerable to contrast agents Patients with prior angioplasty or vascular procedures Patient less than 18 years of age.
The examination will be stated and reports including causes, signs and symptoms, and consequences will be acquired from patients via interview (themes shown in
| Serial number | Question |
|---|---|
| 1 | History of present illness: Intermittent pain/rest pain/ulceration/gangrene |
| 2 | Comorbidities: Diabetes/Hypertension/Ischemic heart disease |
| 3 | History of smoking |
| 4 | Previous surgery if any |
The procedure will be explained to the patient before and after taking consent with colour-coded duplex Sonography, Doppler measurements, and wave-form analysis, throughout the aortic branching to the area of the leg, the entire arterial tree of the target limb will be examined.
The procedure will be explained to the patient and consent will be taken. Patients planned for DSA will be investigated for all routine scan including HIV & HBsAg.
Under strict sterile management and observation of an anaesthesiologist femoral artery punctured in a patient lying on your back after getting at the associated vessel via the Transfemoral path, dye will be infused with the catheter into the targeted vessel.
Social and demographic details Hypertension, smoking, alcohol, diabetes mellites, hyperlipidaemia.
Protocol among Duplex-Ultrasonography and Digital Subtraction Angiography will be assessed using kappa (k) statistics and Sensitivity, Specificity, Positive Predictive Value; Negative Predictive Value will be assessed using appropriate statistical tests. SPSS software will be used.
Information will be displayed as graphical representations, statistics, and illustrations. The results will be examined and compared with those of other studies that will be comparable.
This will encourage the participants for periodic investigation and proper use of medications which will improve hospital/facility outcome. It will be helpful for the condition of peripheral arteries is more common in older adults. Further accurate treatment options will be given to patients.
Post IEC approval, data of 24 patients has been collected so far.
Results will be made available to the institutional scientific committee. The research will be presented at national and international diagnostic/intervention radiology conferences, it will also be submitted as an original article to peer-reviewed journals.
Institutional ethics committee permission from the ethics committee has been received on 21.03.2023 from the DMIHER University.
Ref.No. DMIMS (DU)/IEC/2023/765
All the participants selected for the study will be explained in detail regarding the research proposal; signed consent and information will be kept enclosed.
Outcome would be measured in terms of agreement between degree of stenosis detected for different segments with Duplex-Ultrasonography and Digital Subtraction Angiography and to evaluate threat components for Peripheral Occlusive Arterial Disease along with its location and stenosis.
The condition of peripheral arteries is more likely to affect elderly individuals. Tobacco use is one of the most prevalent contributory factors that affect men.
Findings will only be applicable to our organization because the study will be done at one tertiary care hospital, limiting their external validity and generalizability.
No data are associated with this article.
The current study aims to compare use of Doppler ultrasound to traditional digital subtraction angiography in patients with lower extremity peripheral arterial disease.
The paper is extremely unclear as to the main objective of the analysis and what question it will answer. If the idea is a comparison between doppler ultrasound and digital subtraction angiography, DSA is known to be superior, but usually reserved for more severe patients given that it is an invasive procedure.
The paper needs to be rewritten to project a clear hypothesis.
Introduction:
Under introduction, several paragraphs need to be reworded to make them concise and more readable.
The last two paragraphs in the introduction section are disjointed and are not related to the paragraphs above and are stand alone lines. I am assuming the authors want to describe the premise of using Doppler ultrasound however it is unclear from the last line in the introduction which does not seem to be connected to the rest of the introduction.
Rationale:
The authors mention “the appropriate line of action is determined by diseases intensity, this may call for pairing therapies”. This line is unclear.
Aim:
Under the aim of the study, the authors mention that they aim to compare Doppler and angiogram in distal occlusive arterial disease. The authors need to specify what
Methodology/ Patient population
Furthermore, under patient population the authors mentioned that they will include patients with complaints of peripheral vascular disease that come to the clinic/ OPD
What are these complaints? They state that they will obtain records of patients with PAD from nursing supervisor- how are they documenting this and keeping a log? DO they keep a log of complaints? Do they keep a log of the diagnosis? Who makes the diagnosis? Furthermore, importantly, the authors make no mention of which patients will undergo Doppler ultrasound, how will they determine that which patient should undergo digital substation angiography? Who will be performing these ultrasounds, and making decisions regarding need for angiography, who will be performing the angiography and making comparison with the ultrasound? Under implications the authros mention that this will help participants to adhere to medications- how will conducting a test help participants with medication adherence? You cannot draw such implications from this paper It states that it will help with the 'condition of peripheral arterial vessels in older adults" - how? why older? You are including everyone over 18 - so why older? The authors conclude that PAD is prevalent in olders adults and smokers- and has no bearing on the paper. They need to concentrate on available data on doppler ultrasound and DSA and shortcomings that the study is looking at.
Implications
Conclusion
Is the study design appropriate for the research question?
No
Is the rationale for, and objectives of, the study clearly described?
No
Are sufficient details of the methods provided to allow replication by others?
No
Are the datasets clearly presented in a useable and accessible format?
No
Reviewer Expertise:
Peripheral arterial disease, pulmonary embolism
We confirm that we have read this submission and believe that we have an appropriate level of expertise to state that we do not consider it to be of an acceptable scientific standard, for reasons outlined above.