Intermittent Claudication Patients Research Articles

Major Adverse Limb Events in Patients Undergoing Revascularisation for Lower Limb Peripheral Arterial Disease: A Nationwide Observational Study

Major adverse limb events (MALEs) are frequent in patients with lower extremity peripheral arterial disease (PAD). However, routine care MALE rate estimations after revascularisation are scarce. This study aimed to determine post-procedural MALE rates in revascularised patients with PAD and identify predictors for post-procedural MALEs. This was a population based observational study on merged national registry data. Patients with PAD undergoing lower limb revascularisation between 2008 and 2016 were retrieved from the Swedish National Registry for Vascular Surgery. Information on comorbidities, medications, and post-procedural MALE endpoints were identified in national healthcare registries. Primary outcomes of interest were categorised as 2 - 4 point MALE composites that included limb amputation, acute lower limb ischaemia, progression to or relapse of chronic limb threatening ischaemia (CLTI), and ipsilateral re-interventions regardless of indication. Patients with intermittent claudication (IC) and CLTI were analysed separately using Kaplan-Meier estimates. Stepwise Cox proportional hazard models were used for predictor candidate analysis. Overall, 28 021 revascularised patients with PAD were analysed (IC, n = 10 506, 37.5%; CLTI, n = 17 515, 62.5%). During a mean follow up ± standard deviation of 3.2 ± 2.4 years, 5 226 (18.7%), 9 423 (33.6%), and 12 696 (45.3%) patients experienced a 2, 3, and 4 point MALE, respectively. The estimated one year 4 point MALE rates were 21.4% (95% confidence interval [CI] 20.6 - 22.2%) in IC and 46.9% (95% CI 46.1 - 47.7%) in CLTI. Adjusted predictors for experiencing a 4 point MALE in IC were chronic kidney disease (CKD) (hazard ratio [HR] 1.33, 95% CI 1.12 - 1.59) and previous lower limb revascularisation (HR 1.29, 95% CI 1.19 - 1.40). In CLTI, previous contralateral lower limb amputation (HR 1.60, 95% CI 1.47 - 1.73) and CKD (HR 1.25, 95% CI 1.17 - 1.34) were adjusted predictors. This study emphasises the very high MALE rates in revascularised patients with lower limb PAD, especially in CLTI. Prior lower limb revascularisation correlated with increased MALE rates in IC patients, while prior lower limb amputation was linked to subsequent MALEs in CLTI. In both IC and CLTI, CKD was associated with poorer outcomes, regardless of applied MALE definition.

The Association Between Completion of Supervised Exercise Therapy and Long-Term Outcomes in Patients with Intermittent Claudication, Concomitant Sarcopenia, and Cardiometabolic Multimorbidity

The combination of intermittent claudication (IC), cardiometabolic multimorbidity (CMM) and sarcopenia is associated with worse outcomes than IC alone. This study aimed to identify whether the completion of Supervised exercise therapy(SET) attenuates these adverse outcomes in patients with combined IC, sarcopenia and CMM. This registry review included consecutive IC patients with concomitant CMM and sarcopenia, who were referred for SET from 2014 to 2017. CMM was defined as two or more comorbidities (diabetes, heart disease, stroke, or chronic kidney disease). Sarcopenia was assessed using the L3-skeletal muscle index (L3SMI) from CT scans in the preceding 18 months. Outcomes of interest were progression to chronic limb-threatening ischemia (CLTI), major adverse cardiovascular events (MACE), and major adverse limb events (MALE). Survival and Cox regression analyses were performed. Eighty-two patients with a combination of IC, CMM and sarcopenia were included. Of these, 56 declined or prematurely discontinued SET and 26 completed SET. Baseline characteristics and L3SMI did not significantly differ between groups. Completion of SET was associated with slower progression to CLTI (HR: 0.23; 95% CI: 0.07-0.69; p = 0.02) and a reduced risk of MALE (HR: 0.21; 95%CI: 0.057-0.775;p=0.02). However, there was no reduction in the risk of MACE (HR: 0.88; 95%CI: 0.423-1.629; p=0.73). Models demonstrated good predictive accuracy (Harrell's C-index>0.6). Completion of SET was associated with significant improvements in adverse limb outcomes in patients with IC, concomitant sarcopenia and CMM.

Five Year Survival in Medicare Patients Undergoing Interventions for Peripheral Arterial Disease: a Retrospective Cohort Analysis of Linked Registry Claims Data

To justify upfront risks of offering elective interventions for intermittent claudication (IC), patients should have reasonable life expectancy to derive durable clinical benefits. Open surgery for chronic limb threatening ischaemia (CLTI) is maximally beneficial in patients surviving ≥ 2 years. Our goal was to assess long term survival after IC and CLTI interventions. In a retrospective cohort analysis, the Vascular Quality Initiative (VQI) registry from 1 January 2010 to 31 May 2021 was queried for peripheral vascular intervention (PVI), infra-inguinal bypasses (IIB), and supra-inguinal bypasses (SIB) for IC and CLTI across 286 US centres. VQI linkage to Medicare insurance claims provided 5 year survival data. Multivariable analysis identified factors associated with 5 year mortality. There were 31 457 PVIs (44.7% IC, 55.3% CLTI), 7 978 IIBs (26.9% IC, 73.1% CLTI), and 2 149 SIBs (50.1% IC, 49.9% CLTI) recorded in the VQI. Among PVI, IIB, and SIB cohorts, average ages were 75, 73, and 72 years, respectively. Respective 5 year mortality after PVI for IC and CLTI was 37.2% and 71.1%; after IIB for IC and CLTI it was 37.8% and 60%; and after SIB for IC and CLTI it was 33.8% and 53.8%. On multivariable analysis, across all procedures, end-stage renal disease, CLTI, congestive heart failure, anaemia, chronic obstructive pulmonary disease, and prior amputation were independently associated with increased mortality. Pre-admission home living and pre-operative aspirin use were independently associated with decreased mortality. Long term survival in Medicare patients undergoing interventions in VQI centres for peripheral arterial disease is poor. Two thirds of CLTI patients and over one third of IC patients were not alive at 5 years. Intervening for IC in patients with high mortality risk should be avoided. For CLTI patients identified with decreased survival likelihood, intervention durability may be less important than invasiveness. Pre-operative medical optimisation should always be undertaken.

Neuromuscular electrical stimulation as an adjunct to standard care in improving walking distances in intermittent claudication patients: the NESIC RCT

Background Peripheral arterial disease is common and associated with increased cardiovascular morbidity and mortality. While patients with peripheral arterial disease are known to benefit from supervised exercise therapy, it is not always available. Neuromuscular electrical stimulation devices may offer a similar benefit. A randomised controlled trial was required to ascertain whether such devices can benefit patients who receive supervised exercise therapy and those who do not. Objective(s) The primary objective was to assess the mean difference in absolute walking distance at 3 months in intermittent claudication patients receiving either a neuromuscular electrical stimulation device and local standard care (intervention), or local standard care alone (control). Design A pragmatic, multicentre, randomised controlled trial stratified by centre. Setting Secondary-care National Health Service hospitals in the United Kingdom. Participants Patients aged ≥18 years, with a diagnosis of intermittent claudication according to the Edinburgh Claudication Questionnaire and ankle–brachial pressure index (or stress test), without contraindications to neuromuscular electrical stimulation were deemed eligible to partake. Interventions Participants were randomised 1 : 1 to either local standard care or local standard care and neuromuscular electrical stimulation. Due to the nature of the intervention, it was unfeasible to blind the research nurse or participant to the study allocation. Main outcome measures The primary outcome measure was absolute walking distance measured by treadmill testing at 3 months. Secondary outcomes included change in initial claudication distance, quality of life, compliance with interventions and haemodynamic assessments. Results Two hundred patients underwent randomisation, with 160 patients having analysable primary outcome data for the intention-to-treat analysis intervention (n = 80); control (n = 80). As the data were right-censored, a Tobit regression model was used to analyse the primary outcome, utilising the square root of the absolute walking distance to accommodate the skewed data. However, as this made the data difficult to interpret, a Tobit regression model using raw absolute walking distance data was used as well. Neuromuscular electrical stimulation improved the difference in absolute walking distance at 3 months but this was not statistically significant (square root of absolute walking distance: 0.835 units, 95% confidence interval −0.67 to 2.34 units; p = 0.28/absolute walking distance raw data: 27.18 m, 95% confidence interval −26.92 to 81.28 m; p = 0.323). Supervised exercise therapy participants showed a markedly improved absolute walking distance compared with patients receiving best medical therapy only at 3 months (square root of absolute walking distance: 3.295 units 95% confidence interval 1.77 to 4.82; p < 0.001/absolute walking distance raw data: 121.71 m, 95% confidence interval 67.32 to 176.10; p ≤ 0.001). Neuromuscular electrical stimulation significantly improved absolute walking distance at 3 months for mild claudicants (square root of absolute walking distance: 2.877 units, 95% confidence interval 0.51 to 5.25; p = 0.019/absolute walking distance raw data: 120.55 m, 95% confidence interval 16.03 to 225.06; p = 0.03) compared to the control arm. This was an unplanned (post hoc) analysis. There were no clear differences in mechanistic measurements between the two treatment groups over the follow-up period. Serious adverse events were evenly reported between the two groups; all being classified as either not related or unlikely to be related to the study device. Limitations Absolute walking distance was used as the primary outcome measure; there was a large range of baseline distances in both groups with right-skewed distribution. We did not stratify by baseline absolute walking distance for the primary outcome analysis. Additionally, only 160 patients had analysable primary outcome data due to missing treadmill data. Conclusions Supervised exercise therapy is an effective treatment for intermittent claudication. Neuromuscular electrical stimulation appears to be beneficial as an adjunct to supervised exercise therapy and on its own in mild claudicants. Future work Further studies are needed to confirm the effectiveness of neuromuscular electrical stimulation in combination with supervised exercise therapy, and in mild to moderate claudicants in a larger sample size. Study registration This trial is registered as ISRCTN18242823. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR) partnership (project number 15/180/68). This will be published in full in Efficacy and Mechanism Evaluation; Vol. 10, No. 2. See the NIHR Journals Library website for further project information. Infrastructure support for this research was provided by the NIHR Imperial Biomedical Research Centre (BRC) (with others, e.g. NIHR Imperial CRF, Imperial College ECMC, NIHR Imperial PSTRC, NIHR London MIC, etc.).

Outcomes After Interventions for Intermittent Claudication in Patients with End-stage Renal Disease Are Poor

Outcomes After Interventions for Intermittent Claudication in Patients with End-stage Renal Disease Are Poor

A Double Blind, Placebo Controlled, Randomised Trial of Extracorporeal Shockwave Therapy as a Novel Treatment For Intermittent Claudication

Objective: Peripheral occlusive arterial disease affects 202 million people worldwide, with intermittent claudication as its most prevalent manifestation. The recommended management for non-life limiting intermittent claudication is conservative and includes best medical therapy in the form of antiplatelet and statin therapy, smoking cessation, and supervised exercise. However, provision of supervised exercise programmes and uptake among intermittent claudication patients is very poor. Extracorporeal shockwave therapy (ESWT) technology has been adapted from renal lithotripsy to a variety of musculoskeletal uses and in vitro and in vivo data has shown improved perfusion of the myocardium and hind leg in the setting of arterial ischaemia. Pilot data has demonstrated that ESWT is effective for improving walking distances in patients with intermittent claudication.1 This study aims to consider its effectiveness for improving quality of life in patients with intermittent claudication.

A Novel Way to Enhance Compliance in the Conservative Treatment of Intermittent Claudication (IC) Patients with the Help of Remote Monitoring

A Novel Way to Enhance Compliance in the Conservative Treatment of Intermittent Claudication (IC) Patients with the Help of Remote Monitoring

Determination of Treatment Efficacy after Revascularization of Intermittent Claudication Patients by Physical Function Assessment.

There have been few reports examining changes in physical activity (PA) after revascularization of lower extremities from the perspective of physical function at discharge. The purpose of this study was to clarify the effects of physical function before discharge on the amount of PA after discharge in patients who underwent revascularization. The subjects were 34 Fontaine class II patients admitted for elective surgical revascularization or endovascular treatment at two hospitals from September 2017 to October 2019. Triaxial accelerometers were used to measure changes in sedentary behavior (SB) before admission and 1 month after discharge. Multiple regression analysis was performed on the 6-min walking distance (6MWD) at the time of discharge and the change in SB 1 month after discharge; the cutoff value was calculated from the receiver operating characteristic (ROC) curve. SB 1 month after discharge significantly decreased in the decreased SB group compared to the increased SB group (575.5 [400-745.2] vs. 649.5 [453.8-809.2], p <0.01). ROC curve was plotted with SB increase/decrease as the dependent variable and 6MWD at discharge as the independent variable; the cutoff value was 357.5 m. 6MWD measurement at discharge may help predict changes in SB after discharge.

Use of the 11-Item Modified Frailty Index to Determine Accurate Prognosis and Revascularization Strategy in Patients Undergoing Vascular Bypass Surgery for Intermittent Claudication

In cases of intermittent claudication (IC) where traditionally non-invasive management yields unsatisfactory results, revascularization strategy in IC patients is generally decided based on anatomical considerations and the availability of a saphenous vein graft. Life expectancy should also be considered. This study aimed to investigate the relationship between the 11-item modified frailty index (mFI-11) and overall survival (OS) in patients with IC who underwent vascular bypass surgery to facilitate revascularization strategy selection. We reviewed the records of 144 consecutive patients (153 lower limbs) who underwent infrainguinal bypass for IC between 2011 and 2020. Patients were divided into 2 groups based on their mFI-11 score: high frailty (H), mFI score >0.3; and low frailty (L), mFI score ≤0.3. OS was compared among the 2 groups. Rates of graft patency and freedom from major adverse limb event (ffMALE) were also determined and compared. Five-year OS in the L and H groups was 92% and 55% (P <0.001). Multivariate analysis showed that mFI, age, and end-stage renal disease were independent predictors of OS. Five-year rates of primary and secondary patency and ffMALE for vein grafts were 81%, 91%, and 94%, respectively; those for prosthetic grafts were 65%, 80%, and 84%, respectively; the differences were not significant. The mFI-11 was a helpful tool in predicting OS for patients with intermittent claudication (IC) who underwent vascular bypass surgery. Those with high frailty should not undergo open revascularization; however, for IC patients who have either not responded to a regimen of exercise and medication, or have specifically requested a more aggressive approach, obtaining a good score in frailty assessment is useful in determining whether or not bypass surgery would be a viable option.

Long-Term Outcomes following Common Femoral Endarterectomy.

Thromboendarterectomy of the common femoral artery (CFA) for occlusive disease is a crucial procedure in vascular surgery. As an outcome reference for emerging endovascular procedures and new devices, we need more robust evidence of the outcome of this gold standard technique. The purpose of this study was to report 10-year results after femoral endarterectomy (FEA). A retrospective review of medical records at our institution identified eighty consecutive patients (91 limbs) who underwent FEA for CFA lesions. Indications for FEA included 50 limbs (55%) for intermittent claudication (IC) and 39 limbs (43%) with chronic limb-threatening ischemia (CLTI). Two limbs (2%) underwent FEA to prevent hemodynamic steal during extra-anatomical bypass. Adjunctive procedures included endovascular therapy in 32%. CFAs were closed with patch angioplasty in 44%. With a mean follow-up period of 39 months, the survival rates at 3 and 8 years were 85% and 77%, respectively. Limb salvage rates were 92% and 87%. Primary patencies were 98% and 84%. Freedom from target lesion revascularization was 95% at 3 years and 91% at 8 years. Our findings support the durability of FEA, with comparable long-term procedural results in CLTI patients as well as IC patients. Since the FEA is a gate maneuver for hybrid revascularization in CLTI patients, our findings support a strategy combining open and endovascular approaches. Femoral endarterectomy remains a durable solution for common femoral occlusive disease in IC and CLTI in the era of endovascular therapy.

Risk Factor Analysis and Long-Term Outcomes in Patients with Endovascular Revascularization for Intermittent Claudication or Chronic Limb-Threatening Ischemia

The aim of this study is to review long-term outcome and identify risk factors for patients with peripheral arterial disease (PAD) with percutaneous transluminal angioplasty/stent as a primary treatment strategy for intermittent claudication (IC) or chronic limb-threatening ischemia (CLTI). A retrospective cohort study with data collected prospectively from Clinical Data Analysis and Reporting System, departmental database, and Clinical Management System. All patients who underwent endovascular procedures for PAD between January 2011 and December 2020 were identified. The primary outcomes are overall survival and amputation-free survival. Predictive factors for OS and AFS were determined using Cox Model. A total number of 640 patients with PAD (IC, n=243; CLTI, n=377) underwent endovascular percutaneous transluminal angioplasty/stenting for PAD from January 2011 to December 2020. Patients with CLTI had a significantly higher 30days readmission rate (18.8% vs. 6.5%, P<0.001), emergency reoperation within 30days (3.4% vs. 0%, P=0.002), and death within same admission (2.7% vs. 0%, P=0.008) compared to IC patients. The overall survival and amputation-free survival rates were significantly lower in CLTI patients (P<0.0001 and P<0.0001, respectively). On Cox multivariate analysis, CLTI was strongly predictive of all-cause mortality and amputation (hazard ratio [HR] 2.33 and HR 14.92, respectively). In patients with CLTI, chronic kidney disease was an independent predictor of mortality and amputation (HR 1.66 and HR 2.36, respectively). Smoking and ischemic heart disease were also independent predictors of mortality in this subgroup (HR 2.06 and HR 2.43, respectively). Although patients with IC and CLTI both manifest from atherosclerotic occlusive disease of the lower limb arteries, these patients may have different clinical outcomes with significant mortality occurred in both IC and CLTI groups. In patients with IC, the risk of amputation was less than 1% at 5years following revascularization.

Ligamentum flavum hypertrophy significantly contributes to the severity of neurogenic intermittent claudication in patients with lumbar spinal canal stenosis.

Ligamentum flavum hypertrophy (LFH) is a known contributor to lumbar spinal canal stenosis (LSCS). However, the clinical significance and quantitative role of LFH compared to other components, such as disc bulging and facet hypertrophy, have not yet been examined. We investigated the correlation between the quantitative radiological factors, clinical symptoms, and outcomes in patients with LSCS. In total, 163 patients diagnosed with single-level (L4-L5) stenosis were included. The patients were divided into 2 groups according to claudication severity: >100 m for mild (n = 92) and < 100 m for severe (n = 71). The visual analog scale (VAS) was used to quantify back and leg pain, and the Oswestry Disability Index (ODI) and Short form-36 (SF-36) physical component summary (PCS) scores, and Macnab criteria were evaluated as clinical factors 6 months after treatment. We measured the baseline canal cross-sectional area, ligamentum flavum (LF) area, disc herniation area, dural sac area, fat area, and LF thickness using MRI. A comparative analysis was performed to evaluate the association between radiologic and clinical factors. Additionally, further comparative analyses between the types of surgeries were performed. Among various radiologic factors, the baseline LF thickness (odds ratio [OR] 1.73; 95% confidence interval [CI] 1.25-2.41) was the only major contributing factor to the severity of claudication in the multivariate logistic regression analysis. The types of surgery (decompression alone vs fusion) did not significantly differ in terms of their clinical outcomes, including back and leg VAS, ODI, SF-36 PCS, and satisfaction with the MacNab classification. LF thickness is a major factor contributing to claudication severity.

Systematic review and meta-analysis comparing the autogenous vein bypass versus a prosthetic graft for above-the-knee femoropopliteal bypass surgery in patients with intermittent claudication.

According to guidelines, the autogenous saphenous vein (ASV) is the preferred conduit for femoropopliteal bypass surgery in all patients with peripheral artery disease. However, in contrast to patients with critical limb ischemia (CLI), patients with intermittent claudication (IC) only, tend to have milder disease, and thus a prosthetic graft may be as good as a vein conduit. The objective of this study was to compare patency rates of the ASV and a prosthetic graft in femoropopliteal bypass surgery in patients with IC. A systematic literature search was performed in the PubMed, Embase, and Cochrane databases to identify randomized controlled trials comparing prosthetic graft versus ASV in patients with IC. Articles with a mixed IC and CLI study population were included if more than 50% of the study cohort was treated for IC. Primary analysis was performed on IC patients only. Secondary analysis was performed on the mixed group. The primary endpoint was short- and long-term patency and secondary endpoints were complications, limb salvage, and mortality. In total, six studies with 524 patients were included. Only two studies reported solely on patients with IC. All these patients underwent above-the-knee bypasses and average patency rates at one and 5years were 88% and 76% vs 81% and 68% in the ASV and the PTFE groups, respectively. One and five-year patency was not statistically different between the groups (OR 5.21; 95% CI 0.60-45.36 and OR 2.10; 95% CI 0.88-5.01). In a mixed population of patients with IC and CLI (84% IC patients), 1year patency was comparable (OR 1.40; 95% CI 0.87-2.25). However, after a follow-up of over 3years, this mixed group had significantly higher patency rates in favour of the ASV (OR 2.06; 95 % CI 1.30-3.26). Complication and amputation rates were comparable in both groups. Limited data are available for patients receiving above-the-knee femoropopliteal bypass for intermittent claudication. The ASV remains the conduit of choice for femoropopliteal bypass surgery. However, the prosthetic conduit seems a feasible alternative for patients with intermittent claudication in whom the ASV is not present or unsuitable.

Skeletal muscle MiR-210 expression is associated with mitochondrial function in peripheral artery disease patients

Previous studies have demonstrated that circulating microRNA (miR)-210 levels are elevated in peripheral artery disease (PAD) patients. MiR-210 is known to be a negative regulator of mitochondrial respiration; however, the relationship between miR-210 and mitochondrial function has yet to be studied in PAD. We aimed to compare skeletal muscle miR-210 expression of PAD patients to non-PAD controls (CON) and to examine the relationship between miR-210 expression and mitochondrial function. Skeletal muscle biopsies from CON (n=20), intermittent claudication (IC) patients (n=20), and critical limb ischemia (CLI) patients (n=20) were analyzed by high-resolution respirometry to measure mitochondrial respiration of permeabilized fibers. Samples were also analyzed for miR-210 expression by real-time PCR. MiR-210 expression was significantly elevated in IC and CLI muscle compared to CON (P=0.008 and P < 0.001, respectively). Mitochondrial respiration of electron transport chain (ETC) Complexes II (P=0.001) and IV (P < 0.001) were significantly reduced in IC patients. Further, CLI patients demonstrated significant reductions in respiration during Complexes I (state 2: P=0.04, state 3: P=0.003), combined I and II (P < 0.001), II (P < 0.001), and IV (P < 0.001). The expression of the miR-210 targets, cytochrome c oxidase assembly factor heme A: farnesyltransferase (COX10), and iron-sulfur cluster assembly enzyme (ISCU) were down-regulated in PAD muscle. MiR-210 may play a role in the cellular adaptation to hypoxia and may be involved in the metabolic myopathy associated with PAD.

Update on Cilostazol: A Critical Review of Its Antithrombotic and Cardiovascular Actions and Its Clinical Applications.

Cilostazol, a phosphodiesterase III inhibitor, has vasodilating and antiplatelet properties with a low rate of bleeding complications. It has been used over the past 25 years for improving intermittent claudication in patients with peripheral artery disease (PAD). Cilostazol also has demonstrated efficacy in patients undergoing percutaneous revascularization procedures for both PAD and coronary artery disease. In addition to its antithrombotic and vasodilating actions, cilostazol also inhibits vascular smooth muscle cell proliferation via phosphodiesterase III inhibition, thus mitigating restenosis. Accumulated evidence has shown that cilostazol, due to its "pleiotropic" effects, is a useful, albeit underutilized, agent for both coronary artery disease and PAD. It is also potentially useful after ischemic stroke and is an alternative in those who are allergic or intolerant to classical antithrombotic agents (eg, aspirin or clopidogrel). These issues are herein reviewed together with the pharmacology and pharmacodynamics of cilostazol. Large studies and meta-analyses are presented and evaluated. Current guidelines are also discussed, and the spectrum of cilostazol's actions and therapeutic applications are illustrated.

Critical appraisal of evidence on bypass surgery versus endovascular treatment for intermittent claudication: a systematic review and meta-analysis.

Intermittent claudication (IC) stage of peripheral artery disease (PAD) is associated with significant impairment of quality of life. In the subset of patients with disabling IC refractory to best medical treatment (BMT), revascularization procedures may be considered. However, evidence comparing open revascularization surgery, endovascular treatment and BMT focusing on the impact on quality of life is very sparse. We aim to review clinical, anatomical and hemodynamic outcomes after bypass surgery compared to BMT and/or endovascular treatment in IC patients. We systematically reviewed controlled trials and comparative cohort studies assessing quality of life, walking performance, clinical/ symptomatic improvement, symptom recurrence, patency rates, Ankle-Brachial Index (ABI) improvement and adverse events after bypass surgery versus endovascular treatment/BMT in IC patients. Eleven studies involving 16,608 patients were included. Compared to BMT, bypass surgery was associated with a significantly greater improvement on Short-Form 36 (SF-36) physical functioning score (mean difference (MD), -14.0; 95% confidence interval [CI], -21.2 to -6.8), Walking Impairment Questionnaire (WIQ) walking distance score (MD, -0.23; 95% CI, -0.29 to -0.16) and SF-36 bodily pain score (MD, -13.0; 95% CI, -20.2 to -5.8). There were no significant differences between bypass and endovascular treatment regarding the three scores. Bypass surgery presented better primary patency rates at 1 (odds ratio [OR], 0.47; 95% CI, 0.29 to 0.76) and 5 years (OR, 0.44; 95% CI, 0.34 to 0.57) and better ABI improvement (MD, -0.07; 95% CI, -0.12 to -0.03) when compared to endovascular treatment. There were no statistically significant differences between bypass and endovascular patients regarding secondary patency rates, 30-day mortality and major amputation. Lower limb revascularization may be beneficial in patients with disabling and refractory IC when the primary goal is to improve quality of life and walking capacity. Bypass surgery is associated to better symptomatic status, long-term primary patency and ABI improvement when compared to endovascular surgery, especially in anatomically extensive disease. Further studies addressing patient-reported outcomes and including a BMT group are paramount for more robust evidence on IC treatment and, consequently, better decision making.

Clinical profile of patients with peripheral artery disease treated with high-pressure intermittent pneumatic compression in st. lukes medical center-quezon city: a 6-year retrospective cohort study

Abstract Background High-pressure intermittent pneumatic compression (HPIPC) has been proposed as an alternative intervention to supervised exercise to improve intermittent claudication in patients with peripheral artery disease (PAD). This intervention has already been introduced in the Philippines. However, no local data have been published regarding the clinical profile of patients with PAD treated with HPIPC. This study aims to determine the clinical profile of patients with PAD treated with HPIPC in our Medical Center from March 2015 to March 2021. Purpose Knowledge about the clinical profile of patients with PAD treated with HPIPC in SLMC-QC will provide local data that can lead to better planning of the next generation of PAD care in our institution or even in the Philippines. This study can therefore serve as a baseline for further studies to identify clinical outcomes using HPIPC. Methods A total of eighty-three (N=83) adult patients aged ≥19 years with confirmed diagnosis of PAD and symptoms of intermittent claudication who received at least 12 sessions of HPIPC in the Department of Vascular Medicine from March 2015 to March 2021 were included in this retrospective cohort study. The primary outcome was identification of the clinical profile of the study population that included age, sex, smoking history and co-morbidities such as hypertension, diabetes mellitus (DM), dyslipidemia, coronary artery disease (CAD) and chronic kidney disease (CKD). The secondary outcome was description of the clinical outcomes of the study population after a minimum of 12 sessions of HPIPC. Descriptive statistics were generated for all variables. Continuous variables were presented as mean (standard deviation, SD)'. Nominal and ordinal data were reported as frequencies and percentages. All data were analyzed using Statistical Package for the Social Sciences (SPSS) v27 software. The flow diagram of the study is shown in Figure 1. Results The mean (SD)' age of the study population was 75 (14)' years. Approximately 76% of them were aged ≥65 years. Overall, there were more males (57%) than females (43%) in the study. Majority of the study population were never-smokers (70%), had hypertension (89%), DM (81%), dyslipidemia (78%) and abnormal ankle-brachial index (ABI, 80%). The mean (SD)' ABI of the study population was 0.92 (0.5)'. 92% had hemodynamically significant stenosis in the distal arterial segments of the lower extremities while 62% had hemodynamically significant stenosis in the proximal arterial segments of the lower extremities (Table 1). Conclusion Age ≥65 years, male sex, never-smoker, hypertension, DM and dyslipidemia defined the clinical profile of patients with PAD treated with HPIPC in SLMC-QC from March 2015 to March 2021. Appropriate management of these risk factors can lead to better PAD care in the institution. Further studies are recommended to determine the efficacy of HPIPC in the treatment of PAD. Funding Acknowledgement Type of funding sources: None. Figure 1. Flow diagram of the studyTable 1. Results of the study

Assessment of Walking Ability in Patients with Intermittent Claudication Using a Smartphone Accelerometer

<strong>Objectives:</strong> It is challenging to accurately monitor the progress of intermittent claudication patients during or after treatment. Furthermore, diagnostic tools for intermittent claudication are not always adequate to determine whether other diseases are the primary cause of any walking complaints. This makes it difficult to determine the optimal treatment for the patient and impairs proper follow-up. The objective was to investigate the feasibility of measuring disease specific changes in the gait pattern of intermittent claudication patients by using a smartphone accelerometer. <strong>Methods:</strong> This study is a clinical Proof-of-concept study. Included were 12 subjects. Seven of the subjects were healthy controls, the other five intermittent claudication patients. Raw accelerometer data was collected during a standardized walking test with an Iphone. Processed data was analyzed using the GaitPy package in Python, resulting in 20 different gait parameters per gait cycle. The data were divided, resulting in three groups: The control group, the patient group without symptoms and the patient group with active symptoms. Mann-Whitney U tests and Wilcoxon ranks test were used to examine the outcomes. <strong>Results:</strong> Five of the 20 parameters are significantly different between patients before symptoms and patients with active symptoms. All parameters except cadence and stride duration differ between our control group and the patients while experiencing symptoms. Nine of 20 parameters where significantly different between the control group and the patient group without symptoms. <strong>Conclusions:</strong> This study demonstrated the potential clinical applicability of measuring changes in intermittent claudication gait characteristics with a smartphone.

Additive prognosis of clinical presentation in revascularized peripheral arterial disease patients.

Peripheral artery disease (PAD) is a frequent cause of morbidity and mortality. It may present with diverse clinical presentations. The aim of this study was to evaluate the prognosis of these clinical presentations. We performed a retrospective cohort study, in which symptomatic PAD patients were included from 2014 to 2020 at a university hospital in Argentina. We classified symptomatic PAD in intermittent claudication (IC), chronic limb-threatening ischemia (CLTI) and acute ischemia (AI). Our primary endpoint was to compare the composite of all-cause mortality and major amputation events between the three groups. We included 309 patients, with a median follow up of 1.87 years (IQR 0.72-3.67). The primary endpoint was more prevalent in CLTI and AI patients (33% and 33.3%) compared to IC patients (8.1%), P<0.001. CLTI and AI were independently associated with the primary endpoint after adjusting for clinical variables of interest (OR 4.04 95%CI [1.86-9.07], P<0.001 and OR 5.40 95%CI [2.18-13.7], P<0.001, respectively). Mortality incidence rate (per 100 patients/year) was similar between AI and CLTI patients (14.2 95% CI [8.0-24.1] and 13.1 95%CI [8.8-19.7], respectively, P=0.67) but higher compared to IC (2.9 95%CI [1.6-5.1], P<0.01). Major amputation events were more prevalent in CLTI (16.5%) compared to AI (8.9%) and IC patients (1.2%), P<0.01. Those with CLTI and AI have a particular increased risk of all-cause death and major amputation events. Although mortality incidence was similar between AI and CLTI patients, the latter have an increased risk of major amputation events compared to AI and IC patients.

The association of healthcare disparities and patient-specific factors on clinical outcomes in peripheral artery disease

PAD increases the risk of cardiovascular mortality and limb loss, and disparities in treatment and outcomes have been described. However, the association of patient-specific characteristics with variation in outcomes is less well known. Patients with PAD from Duke University Health System (DUHS) between January 1, 2015 and March 31, 2016 were identified. PAD status was confirmed through ground truth adjudication and predictive modeling using diagnosis codes, procedure codes, and other administrative data. Symptom severity, lower extremity imaging, and ankle-brachial index (ABI) were manually abstracted from the electronic health record (EHR). Data was linked to Centers for Medicare and Medicaid Services data to provide longitudinal follow up. Primary outcome was major adverse vascular events (MAVE), a composite of all-cause mortality, myocardial infarction (MI), stroke, lower extremity revascularization and amputation. Of 1,768 patients with PAD, 31.6% were asymptomatic, 41.2% had intermittent claudication (IC), and 27.3% had chronic limb-threatening ischemia (CLTI). At 1 year, patients with CLTI had higher rates of MAVE compared with asymptomatic or IC patients. CLTI and Medicaid dual eligibility were independent predictors of mortality. CLTI and Black race were associated with amputation. Rates of MAVE were highest in patients with CLTI, but patients with IC or asymptomatic disease also had high rates of adverse events. Black and Medicaid dual-eligible patients were disproportionately present in the CLTI subgroup and were at higher risk of amputation and mortality, respectively. Future studies must focus on early identification of high-risk patient groups to improve outcomes in patients with PAD.