Walking Impairment Questionnaire Scores Research Articles

Validation of the Lithuanian Version of the Walking Impairment Questionnaire in Patients with Peripheral Arterial Disease.

Background and Objectives: The Walking Impairment Questionnaire (WIQ) is a short and simple tool to measure walking impairment for patients with peripheral arterial disease requiring no special equipment or trained staff. The aim of this study was to assess the validity and reliability of the culturally adapted Lithuanian WIQ version in patients with intermittent claudication. Materials and Methods: In total, 40 patients with intermittent claudication and ankle-brachial index < 0.90 participated in this study. Reliability and internal consistency of the questionnaire were assessed by the intra-class correlation coefficient (ICC) and Cronbach's alpha (α), respectively. Validity was determined by correlations between the WIQ scores and a subjective test (Quality of Life 5 Dimension Questionnaire 3 Level Version (EQ-5D-3L)) and objective tests (6 min walk test (6MWT), treadmill test, and ankle-brachial index). Results: The test-retest reliability was assessed as excellent with an intraclass correlation coefficient of 0.90. The values of Cronbach's alpha were 0.957 (I time) and 0.948 (II time) and indicated an excellent internal consistency. Statistically significant Spearman correlations were detected between the WIQ and walking distances on the 6MWT (rho 0.514, p < 0.001) and treadmill test (rho 0.515, p < 0.001). Higher WIQ scores were associated with longer walking distances and duration. Moderate negative and low negative correlations were found between the WIQ and EQ-5D-3L scores. Conclusions: The Lithuanian version of culturally adapted WIQ demonstrates reliability and validity for patients with intermittent claudication, supported by two different walking tests showing statistically significant moderate Spearman correlations.

Gujarati translation, validity and reliability of Walking Impairment Questionnaire in people with intermittent claudication due to peripheral artery disease

IntroductionThe Walking Impairment Questionnaire (WIQ) is a common and easy-to-use assessment of walking incapacity in people with claudication due to peripheral artery disease (PAD). It has four subscales: pain severity, walking distance, walking speed, and ability to climb stairs. It has not been translated into Gujarati, which limits its use in Indian subjects. AimThis study aims to translate and assess the validity and reliability of a Gujarati version of WIQ. Materials and MethodsThis study had three phases: 1. Forward and backward translation and Cultural adaptation of WIQ into the Gujarati language by two independent translators, 2. Face and content validation by six clinical reviewers and 10 participants with PAD and Type II diabetes, 3. Concurrent and construct validity, test-retest reliability, and internal consistency of Gujarati, the WIQ was assessed on 160 participants with PAD and Type II diabetes who had a mean Ankle Brachial Index (standard deviation) <0.40 (0.1). The concurrent and construct validity of the WIQ was analyzed by correlating the WIQ distance and speed score with 6-minute walk distance (6MWD) and speed and WIQ total score with the Medical Outcome Study Questionnaire Short Form 36 (SF-36) score using Pearson's correlation coefficient. Test-retest reliability was analyzed using an intraclass correlation coefficient (ICC) with a seven-day interval between two questionnaire applications. Internal consistency of the total WIQ score was determined using Cronbach's alpha. ResultsFollowing translation, the Gujarati WIQ was considered acceptable and understandable by people with PAD. There was excellent correlation between the WIQ distance score and 6-minute walk test distance (r = 0.95, P < .05)) , the WIQ speed score and 6-minute walk test speed score (r = 0.89, P < .05)) and the Gujarati WIQ total score and total score of physical functioning domain of SF- 36 (r = 0.99, P < .05). There was excellent test-retest reliability over 7 days for total WIQ score (ICC = 0.94). The Cronbach's alpha for internal consistency of 0.97 for total WIQ score were excellent. This demonstrates the sufficient homogeneity of the total questionnaire. ConclusionThe Gujarati version of the WIQ is reliable and valid and can be used to assess self-reported walking impairment in Gujarati-speaking people with PAD and Type II Diabetes.

Is the Walking Impairment Questionnaire a surrogate marker of 6-minute walking test performance in patients with peripheral artery disease with different degrees of claudication symptoms?

To analyze the associations between the Walking Impairment Questionnaire (WIQ) and 6-minute walk test (6MWT) in absolute or relative performance in patients with peripheral artery disease (PAD) and different degrees of claudication symptoms. Two hundred and sixty-seven patients with PAD and claudication symptoms participated in the study. All patients underwent 6MWT and WIQ tests. Patients were divided into tertile groups according to their 6MWT performance (1st tertile = severe, 2nd = moderate, 3rd = mild). Multiple linear regression was performed to investigate the association between WIQ scores and the achievement of expected performance in the 6MWT. Claudication onset distance and time, total walking distance, and the percentage of the predicted values had a significant weak correlation (P < 0.01) with WIQ scores (distance, speed, and stair-climbing capacity). The correlations for almost all variables were slightly higher in the 1st tertile compared with the 2nd and 3rd tertiles (i.e. WIQ-distance and Claudication onset time, r = 0.25 and 0.12, WIQ-distance and Claudication onset distance, r = 0.34 and 0.18; WIQ-distance and total walking distance, r = 0.23 and 0.18, respectively). Multilinear regression confirmed a slightly superior relationship in the 1st tertile compared with the 2nd tertile (i.e. WIQ-distance and Claudication onset time, R2 = 0.24 and R2 = 0.01; WIQ-distance and Claudication onset distance, R2 = 0.25 and R2 = 0.03, respectively). WIQ is weakly associated with absolute and relative 6MWT performance in patients with PAD. Despite slightly better correlations in patients with severe claudication symptoms, WIQ scores must be used with care as a surrogate marker of 6MWT performance in this group.

Use of the Walking Impairment Questionnaire and Walking Estimated-Limitation Calculated by History questionnaire to detect maximal walking distance equal to or lower than 250 m in patients with lower extremity arterial disease.

The objective was to assess the accuracy and optimal threshold of the Walking Impairment Questionnaire (WIQ) and the Walking Estimated-Limitation Calculated by History (WELCH) questionnaire in identifying patients with a maximal walking distance (MWD) below or equal to 250 m. This retrospective study screened 388 consecutive patients with suspected symptomatic lower extremity arterial disease (LEAD). Collected data included the patient's history, resting ankle-brachial index, WIQ, and WELCH. MWD was assessed with a treadmill test at 2 mph (3.2 km/h) with a 10% grade. An optimized threshold for detection of MWD ≤ 250 m was determined for each questionnaire via receiver operating characteristic (ROC) curves. Subsequently, multivariate analysis was performed to build a new simple score to detect MWD ≤ 250 m. The study included 297 patients (63 ± 10 years old). With a threshold of ≤ 64%, the WIQ predicted MWD ≤ 250 m with an accuracy of 71.4% (66.2, 76.5%). With a threshold of ≤ 22, the WELCH predicted a treadmill walking distance of ≤ 250 m with an accuracy of 68.7% (63.4, 74.0%). A new score with only four "yes or no" questions had an accuracy of 71.4% (66.3, 76.6%). Items on this new score consisted of the level of difficulty of walking 1 block, declared maximum walking distance, usual walking speed, and maximum duration of slow walking. A WIQ score ≤ 64% and a WELCH score ≤ 22 help to predict a walking distance of ≤ 250 m in a treadmill test at 2 mph (3.2 km/h) with a 10% grade. A 4-item score could be used for rapid evaluation of walking distance among patients with LEAD, but the validity of this 4-item score requires further confirmation studies.

Tibio-pedal arterial pressure assessment during endovascular intervention to improve quality-of-life in patients with intermittent claudication.

The aim of this study is to compare the quality-of-life (QOL) outcomes and the tibio-pedal arterial pressure post-endovascular intervention. Physiological assessment of peripheral arterial lesions is infrequently performed during endovascular interventions. We retrospectively reviewed all 343 patients with intermittent claudication who underwent an endovascular intervention via tibio-pedal artery access from October 2018 to May 2021. The baseline and post-intervention tibio-pedal arterial pressures from the pedal sheaths were measured. QOL was assessed using a pre-validated Walking Impairment Questionnaire (WIQ) score before and at 30-day after intervention. We compared the baseline tibio-pedal arterial pressure, post-intervention tibio-pedal arterial pressure, delta pressure (post-intervention minus baseline), baseline WIQ scores, 30-day WIQ scores, and delta score (30-day minus baseline). All 343 patients had successful tibio-pedal accesses. The average tibio-pedal arterial pressure at baseline was 87.0 ± 1.8 mmHg vs. 135.5 ± 1.7 mmHg post-intervention (p < 0.001). Average baseline and 30-day WIQ scores were summation (99.8 ± 3.3 vs. 115.0 ± 3.1, p < 0.001), walking distance (35.7 ± 1.3 vs. 42.5 ± 1.3, p < 0.001), walking speed (21.1 ± 0.9 vs. 23.6 ± 0.8, p = 0.036), stair climbing (4.7 ± 1.4 vs. 24.2 ± 1.4, p = 0.019), and symptoms (18.8 ± 0.2 vs. 20.1 ± 0.2, p < 0.001), respectively. When comparing the increased post-intervention tibio-pedal arterial pressure <60 mmHg vs. ≥60 mmHg, the average delta WIQ scores were all significantly improved with summation (10.0 ± 3.9 to 25.8 ± 5.5, p = 0.01), walking distance (4.1 ± 1.7 to 9.8 ± 2.5, p = 0.02), walking speed (1.5 ± 1.1 to 4.3 ± 1.5, p = 0.02), stair climbing (2.3 ± 1.8 to 9.4 ± 2.5, p = 0.02), and symptoms (1.0 ± 0.3 to 1.8 ± 0.4, p = 0.04), respectively. Increasing the post-intervention tibio-pedal arterial pressure by 60 mmHg can enhance QOL as suggested by improvement of WIQ scores.

Abstract 15138: Lower Extremity Arterial Calcification: Association With Walking Impairment in Patients With Peripheral Arterial Disease

Introduction: Increasing prevalence of arterial calcium in the lower extremities of patients with peripheral arterial disease (PAD) is associated with worsening clinical outcomes. Calcium burden can be detected in patients using standard imaging methods. However, quantitative evaluation of calcium burden in specific arteries of the leg in PAD patients is uncommon in the clinical setting, and the association between quantified levels of vessel-specific calcium burden and functional capacity in PAD remains understudied. We hypothesized that x-ray computed tomography (CT) imaging could quantify calcium mass of the superficial femoral (SFA) and popliteal artery and CT-derived measures of calcium burden would be associated with walking impairment scores. Methods: Healthy controls (n=8) and patients with PAD (n=44) underwent CT imaging of the legs. Calcium mass was quantified from CT images by manual segmentation of the combined SFA and popliteal artery from axial images, with established calcium defined as arterial segments with CT image intensities &gt;130 Hounsfield units. To assess functional capacity, the Walking Impairment Questionnaire (WIQ) was administered at the time of imaging. Univariate and multivariate analyses were performed to assess the association between calcium measures and walking impairment scores. Results: WIQ scores for distance, speed, and stairs significantly differed between healthy controls and PAD patients (all scores, p&lt;0.0001). Calcium mass values for the SFA-popliteal artery were significantly higher in PAD patients versus healthy controls (p=0.0005). In univariate analysis, WIQ scores for distance (p=0.004), speed (p&lt;0.001), and stairs (p=0.002) were significantly associated with calcium mass of the SFA-popliteal artery. Associations between WIQ scores and SFA-popliteal artery calcium mass remained significant after adjusting for age and body mass index in multivariate analyses. Conclusions: These results suggest that calcium burden above the knee is significantly associated with walking impairment. Implementation of arterial calcium scoring for the lower extremities in PAD patients may provide novel insight into the relationships between calcium burden, PAD symptoms, and functional limitations.

Effect of Telmisartan on Walking Performance in Patients With Lower Extremity Peripheral Artery Disease

Patients with lower extremity peripheral artery disease (PAD) have reduced lower extremity perfusion, impaired lower extremity skeletal muscle function, and poor walking performance. Telmisartan (an angiotensin receptor blocker) has properties that reverse these abnormalities. To determine whether telmisartan improves 6-minute walk distance, compared with placebo, in patients with lower extremity PAD at 6-month follow-up. Double-blind, randomized clinical trial conducted at 2 US sites and involving 114 participants. Enrollment occurred between December 28, 2015, and November 9, 2021. Final follow-up occurred on May 6, 2022. The trial randomized patients using a 2 × 2 factorial design to compare the effects of telmisartan plus supervised exercise vs telmisartan alone and supervised exercise alone and to compare telmisartan alone vs placebo. Participants with PAD were randomized to 1 of 4 groups: telmisartan plus exercise (n = 30), telmisartan plus attention control (n = 29), placebo plus exercise (n = 28), or placebo plus attention control (n = 27) for 6 months. The originally planned sample size was 240 participants. Due to slower than anticipated enrollment, the primary comparison was changed to the 2 combined telmisartan groups vs the 2 combined placebo groups and the target sample size was changed to 112 participants. The primary outcome was the 6-month change in 6-minute walk distance (minimum clinically important difference, 8-20 m). The secondary outcomes were maximal treadmill walking distance; Walking Impairment Questionnaire scores for distance, speed, and stair climbing; and the 36-Item Short-Form Health Survey physical functioning score. The results were adjusted for study site, baseline 6-minute walk distance, randomization to exercise vs attention control, sex, and history of heart failure at baseline. Of the 114 randomized patients (mean age, 67.3 [SD, 9.9] years; 46 were women [40.4%]; and 81 were Black individuals [71.1%]), 105 (92%) completed 6-month follow-up. At 6-month follow-up, telmisartan did not significantly improve 6-minute walk distance (from a mean of 341.6 m to 343.0 m; within-group change: 1.32 m) compared with placebo (from a mean of 352.3 m to 364.8 m; within-group change: 12.5 m) and the adjusted between-group difference was -16.8 m (95% CI, -35.9 m to 2.2 m; P = .08). Compared with placebo, telmisartan did not significantly improve any of the 5 secondary outcomes. The most common serious adverse event was hospitalization for PAD (ie, lower extremity revascularization, amputation, or gangrene). Three participants (5.1%) in the telmisartan group and 2 participants (3.6%) in the placebo group were hospitalized for PAD. Among patients with PAD, telmisartan did not improve 6-minute walk distance at 6-month follow-up compared with placebo. These results do not support telmisartan for improving walking performance in patients with PAD. ClinicalTrials.gov Identifier: NCT02593110.

First peripheral drug-eluting stent clinical results from China: 1-year outcomes of the Zilver PTX China study.

PurposeThe benefit of using the Zilver PTX drug-eluting stent (DES) in superficial femoral artery (SFA) lesions has been demonstrated in multiple clinical studies. This prospective, multicenter study evaluated the 1-year safety and effectiveness of the DES for the treatment of femoropopliteal lesions in a Chinese patient population.MethodsPatients with a single de novo or restenotic SFA lesion ≤140 mm and a Rutherford classification of 2 to 4 were treated with the DES. The primary endpoint was primary patency assessed by duplex ultrasound at 1-year. Secondary endpoints included adverse events, event-free survival (EFS), and freedom from target lesion revascularization (TLR). Clinical outcomes included Rutherford classification, ankle-brachial index (ABI), and the walking impairment questionnaire (WIQ).ResultsIn this study, 178 patients with symptomatic peripheral artery disease were enrolled at nine institutions in China. The average lesion length was 79.0 ± 48.6 mm (range 14.8–245.4 mm) and 50.0% of lesions were total occlusions. The 1-year primary patency rate was 81.9%. Covariate analysis revealed that lesion length (p < 0.01) was the only significant factor for patency. No paclitaxel-related adverse events or amputations were reported. The 1-year rate for EFS was 94.9% and freedom from TLR was 95.5%. Through 1-year, treatment with the DES resulted in statistically significant improvement in ABI and WIQ scores compared with pre-procedure (p < 0.001). Clinical improvement of at least 1 Rutherford class was achieved in 142 of 174 patients (81.6%).ConclusionThis study showed promising short-term results for the treatment of SFA lesions with Zilver PTX DES in Chinese patients.Unique identifierClinicalTrials.gov, identifier: NCT02171962.

Prospective clinical study for claudication after endovascular aneurysm repair involving hypogastric artery embolization

PurposeThis prospective study aimed to assess the prognosis of claudication after endovascular aneurysm repair (EVAR) involving hypogastric artery (HGA) embolization.MethodsPatients who were scheduled to undergo EVAR involving bilateral or unilateral HGA embolization (BHE or UHE, respectively) between May 2017 and January 2019 were included in this study. Patients underwent the walk test preoperatively, one week postoperatively, and monthly thereafter for six months. The presence of claudication and the maximum walking distance (MWD) were recorded. A near-infrared spectroscopy monitor was placed on the buttocks, and the recovery time (RT) was determined. A walking impairment questionnaire (WIQ) was completed to determine subjective symptoms.ResultsOf the 13 patients who completed the protocol, 12 experienced claudication in the 6-min walk test. The MWD was significantly lower at one week postoperatively than preoperatively. The claudication prevalence was significantly higher at five and six months postoperatively after BHE than after UHE. BHE was associated with longer RTs and lower WIQ scores than UHE.ConclusionsWe noted a trend in adverse effects on the gluteal circulation and subjective symptoms ameliorating within six months postoperatively, with more effects being associated with BHE than with UHE. These findings should be used to make decisions concerning management strategies for HGA reconstruction.

Long-term results of the Japanese multicenter Viabahn trial of heparin bonded endovascular stent grafts for long and complex lesions in the superficial femoral artery

ObjectiveWe assessed the long-term safety and efficacy of endovascular stent grafting to treat long, complex lesions in the superficial femoral artery (SFA). MethodsThe present prospective, multicenter study at 15 Japanese hospitals assessed heparin-bonded stent grafts used to treat long SFA lesions in patients with symptomatic peripheral arterial disease. The inclusion criteria were Rutherford category 2 to 5 symptoms (grade 5 without active infection), an ankle brachial index of ≤0.9, and SFA lesions ≥10 cm long with ≥50% stenosis. The key efficacy and safety outcomes were primary-assisted patency and adverse events through 24 months, respectively. The secondary outcomes included primary patency, secondary patency, freedom from target lesion revascularization (fTLR), and Vascular Quality of Life questionnaire score. ResultsOf the 103 patients (mean age, 74.2 ± 7.0 years; 82.5% male), 100 (97.1%) had intermittent claudication. The average lesion length was 21.8 ± 5.8 cm; 87 lesions (84.5%) were TASC (Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease) C or D (65.7% chronic total occlusions). Of the 103 patients, 92 and 61 were evaluable through 24 and 60 months, respectively. At 24 months, the Kaplan-Meier–estimated primary-assisted patency, primary patency, and secondary patency rate was 85.7% (95% confidence interval [CI], 76.3%-91.5%), 78.8% (95% CI, 68.8%-85.9%), and 92.0% (95% CI, 82.4%-96.5%), respectively. The mean ankle brachial index was 0.64 ± 0.12 at baseline and 0.94 ± 0.19 at 24 months (P < .0001). At 24 and 60 months, the fTLR was 87.2% (95% CI, 78.9%-92.3%) and 79.1% (95% CI, 67.9%-86.8%), respectively. No device- or procedure-related life- or limb-threatening critical events or acute limb ischemia cases were observed through 5 years. No stent fractures were detected on the annually scheduled follow-up radiographs. The vascular quality of life questionnaire and walking impairment questionnaire scores were significantly increased at 1 through 24 months compared with the baseline scores (P < .0001 for both). One patient had required conversion to open bypass during the 5-year follow-up period. ConclusionsStent grafting of long and complex SFA lesions in patients with claudication is safe and effective through long-term follow-up, with 79.1% fTLR and no leg amputation, acute limb ischemia, or stent fractures through 5 years.

Avoiding revascularization strategy versus revascularization with drug-coated balloon for the treatment of superficial femoral artery occlusive disease

ObjectiveThe aim of this study was to compare the efficacy, safety and treatment costs of superficial femoral artery revascularization (SFA) with drug-coated balloon(DCB) versus avoiding revascularization strategy for the treatment of symptomatic SFA disease. MethodsThis retrospective single-center study reviewed 96 patients (113 limbs) with severe stenosis and occlusive SFA disease. All patients underwent either DCB(Group 1: n ​= ​55 limbs) or nonrevascularization (Group 2: n ​= ​58 limbs) between March 2015 and June 2019. The improvement of Rutherford class, walking impairment questionnaire score(WIQ), target limb reintervention, perioperative major adverse events, the catheterization laboratory cost and length of hospital stay were compared. The limb salvage and survival rates were calculated using the Kaplan-Meier method. Univariate and multivariate logistic regression analysis were performed to assess the association between factors and the improvement of Rutherford category at 12 months. ResultsThe median follow-up time of Groups 1 and 2 was 17 and 33 months, respectively. At 12 months, the Rutherford category significantly decreased in both groups (P ​< ​0.001), with no significant difference (79.7% vs. 64.3%, P ​= ​0.074). Furthermore, multivariate analysis showed that the selected therapeutic method was not an influential factor for the improvement of Rutherford class at 12 months. The WIQ overall score as well as three subscales scores (distance, speed and stair-climbing), the survival rate, limb salvage rate and the length of stay between the two groups were comparable. The perioperative adverse events rate and catheterization laboratory cost in Group 2 was significantly lower compared to Group 1 [(34253.69 ​± ​28172.87) yuan vs. (56936.76 ​± ​41278.36) yuan, P ​= ​0.001]. ConclusionsThis study suggests that avoiding superficial femoral artery revascularization strategy has favorable efficacy and safety outcomes compared to combining revascularization with DCB in selected patients.

Ultrasound therapy for treatment of lower extremity intermittent claudication

BackgroundWhile often thought of as a diagnostic tool, ultrasound (US) can also potentially be used as a therapeutic modality. US applies mechanical stress on endothelial cells and induces nitric oxide synthase, which regulates the secretion of nitric oxide, a potent vasodilator. In animal ischemic models, US has been shown to improve hindlimb, myocardial, and cerebral perfusion. We performed a pilot trial of US therapy in the lower extremities of human subjects with intermittent claudication. Methods10 subjects (5 male, 5 female, mean age 69.7 ± 10.3) with intermittent claudication were recruited. Both legs were placed in a specially designed boot with a water interface between US transducers and the legs. Subjects underwent pulsed US therapy at 250 kHz frequency for 30 min for three treatments a week for six weeks. Pre and post treatment ankle:brachial index (ABI), 6-min walk (6 MW), Walking Impairment Questionnaire (WIQ), and Short Form 36 (SF36) were performed. Pre and post-treatment results were compared with paired t-test. ResultsSix minute walking distance at baseline was 352 ± 70 m, after one treatment session 353 ± 70 m (p = 0.99), and at completion 372 ± 71 m (p = 0.015). There was a trend toward improved ABI after 6 weeks of treatment (0.53 ± 0.17 vs 0.64 ± 0.12, p = 0.083). After six weeks, significant improvements were noted in overall WIQ score (2.00 ± 1.48 vs 2.63 ± 1.38, p = 0.0001), WIQ (distance) 2.07 ± 1.54 vs 2.73 ± 1.42 (p = 0.036), and WIQ (stair) 2.00 ± 1.67 vs 2.62 ± 1.24, p = 0.034, with a trend in WIQ (speed), 1.89 ± 1.26 vs 2.46 ± 1.43, p = 0.069. In the SF-36, significant improvements were noted in the domains of physical functioning (44.0 ± 41.6 vs 50.5 ± 41.1, p = 0.009) and role limitations – physical (35.0 ± 48.3 vs 60.0 ± 49.6, p = 0.006) after six weeks. ConclusionsTherapeutic US is a potential noninvasive treatment for intermittent claudication. Pilot study patients noted significant improvements in 6 MW and WIQ results after 6 weeks of treatment. A nonsignificant improvement in ABI was noted. Further research will be needed to clarify optimal treatment frequency and duration.

Three-Year Efficacy and Safety of the Misago Peripheral Stent for Superficial Femoral Artery Disease: Final Results from the OSPREY Trial

PurposeThis study evaluated the long-term outcomes of the Misago peripheral stent trial (Terumo) for atherosclerotic lesions in the superficial femoral artery (SFA) in patients with claudication. Materials and MethodsThis was a prospective multicenter, single-arm, clinical trial of primary stent placement for de novo cases of SFA disease conducted in the United States and Asia. The primary endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) at 36 months. Secondary outcomes were ankle-brachial index (ABI), Rutherford score, Walking Impairment Questionnaire (WIQ), a quality of life survey, and rate of device fracture. ResultsA total of 276 patients (64.4% male; mean age, 69.3 ± 10.1 years) were enrolled. Freedom from CD-TLR was 78.5% (95% confidence interval [CI], 73.0%–83.0%) at 24 months and 75.4% (95% CI, 69.6%–80.2%) at 36 months. Baseline ABI was 0.7 ± 0.1 and 0.98 ± 0.20 (P < .001) at 30 days after the procedure. Baseline Rutherford score was 3.6 ± 0.6 and 1.6 ± 1.0 30 at 30 days after the procedure (P < .001). Mean (and changed) ABI and Rutherford score at 36 months compared to day 30 after the procedure were, respectively, 0.91 (−0.1 ± 0.2) and 1.5 (−0.2 ± 1.1). WIQ score at baseline was 21.49 ± 26.30 and 50.51 ± 38.49 at 30 days after the procedure ( P < .001). The mean WIQ score at 2 years was 46.65 ± 37.31 (P = .12). Stent fracture rate at 36 months was 2.0% (4 of 202 patients). ConclusionsOSPREY (Occlusive-Stenotic Peripheral Artery Revascularization Study) 36-month data demonstrated persistent freedom from CD-TLR and sustained improvement in ABI and Rutherford score with primary stent placement for SFA lesions.

Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac Trial

Background Paclitaxel drug-coated balloon (DCB) catheter angioplasty is the preferred treatment for revascularization of femoropopliteal lesions in peripheral artery disease, but mortality is a safety concern. Purpose To assess 2-year efficacy and safety of DCB angioplasty compared with conventional balloon angioplasty (also known as plain old balloon angioplasty or POBA). Materials and Methods This prospective, multicenter, randomized controlled trial enrolled consecutive participants with symptomatic superficial femoral and/or popliteal artery disease at 11 German centers between September 2015 and December 2016. Participants underwent DCB angioplasty or conventional balloon angioplasty. Primary outcome of 6-month late lumen loss showed superiority of DCB angioplasty over conventional balloon angioplasty. Evaluation at 2 years included secondary outcomes of primary patency and target lesion revascularization (TLR) estimated with Kaplan-Meier analysis, clinical and hemodynamic improvement, quality of life, target limb amputation, and all-cause mortality. Results A total of 171 participants (mean age, 69 years ± 8; 111 men) were evaluated. At 2 years, primary patency was achieved in 90.2% (95% confidence interval [CI]: 80.4%, 95.2%) of DCB angioplasty and 62.7% (95% CI: 50.0%, 73.0%) of conventional balloon angioplasty participants (P < .001). Freedom from TLR occurred in 97.2% (95% CI: 89.1%, 99.3%) of DCB angioplasty and 78% (95% CI: 66.5%, 86.0%) of conventional balloon angioplasty participants (P = .001). The groups did not differ in sustained improvement from baseline to 2 years in Rutherford-Becker category (row mean scores difference, 1.7; P = .19) and showed no difference in mean improvement in the Walking Impairment Questionnaire score (-0.8%; 95% CI: -11.8%, 10.2%; P = .88), EuroQol Group's five-dimension index of quality of life (-0.06; 95% CI: -0.17, 0.03; P = .20), or ankle-brachial index (0.03; 95% CI: -0.08, 0.14; P = .57). No major amputation was necessary. One DCB angioplasty and two conventional balloon angioplasty participants died (risk ratio, 0.48; 95% CI: 0.04, 5.10). Conclusion At 2 years after paclitaxel drug-coated balloon (DCB) angioplasty, primary patency and freedom from target lesion revascularization remained superior compared with conventional balloon angioplasty. DCB angioplasty resulted in sustained clinical and hemodynamic improvement with no increased risk of mortality. © RSNA, 2020 Online supplemental material in available for this article.

Effect of Rood’s Approach in Diabetic Polyneuropathy

Objectives: The objectives of the study were as follows: (1) To find effect of rood’s approach in sensory abnormalities. (2) To find effectof rood’s approach in muscle weakness. Method: Ethical clearance was obtained from the institutional ethical committee. A total of 23 diabetic neuropathy subjects were assessed and 20 were included in this study based on inclusion criteria, the individuals were allocated in one group: This group received Rood’s Approach, depending upon patients condition either facilitatory or inhibitory techniques were given. Diabetic neuropathy was diagnosed using Michigan Neuropathy Screening Instrument Questionnaire and Pre - and post – test were done for assessing severity of diabetic neuropathy using Visual Analogue Scale (VAS), Quantitative sensory testing (QST) and Walking impairment questionnaire (WIQ) and the outcome measures were analysed after 3 months. Results: Within the group statistical analysis, Pre-Post VAS score was 6.43±1.628 and was extremely significant, Pre-Post QST score was 1.900±1.553 and result was extremely significant and Pre-Post WIQ score was 19.150±2.978 was also significant. Conclusion: We found that facilitatory techniques of Rood’s Approach ( Heavy joint compression and quick stretch) were effective in improving decreased sensations and improving motor performance in patients with painful diabetic polyneuropathy.We found that inhibitory techniques of Rood’s Approach (maintained stretch and light joint compression) were effective in decreasing hypersensitivity in patients with painful diabetic polyneuropathy.We found significant improvement in pain measure (VAS), Sensory measure (quantitative sensory testing) and Motor performance measure (walking impairment questionnaire.)

Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions in Patients with Critical Limb Ischaemia: 1-Year Results of the APOLLO Trial.

This study intended to assess effectiveness and safety of the drug-coated balloon (DCB) angioplasty of infrapopliteal atherosclerotic lesions in patients with critical limb ischaemia (CLI) in a real-world setting. Consecutive patients with critical limb ischaemia who underwent infrapopliteal drug-coated balloon angioplasty with the ELUTAX SV DCB were enrolled into the prospective, multicentre, single-arm observational registry. Primary outcome was clinical improvement at 6 and 12months. Secondary outcomes were change in quality of life, primary patency, freedom from repeat revascularisation, and amputation-free survival at 6 and 12months. A total of 164 patients (74.7 ± 9.2years) with CLI were included at nine German sites between November 2015 and September 2017. The majority (79.9%) of patients had diabetes mellitus, 57.3% had renal insufficiency, and 35.3% had coronary artery disease. Mean lesion length was 71.2 ± 76.5mm. The Rutherford category improved by 3.0 ± 2.0 (p < 0.0001) within 12months, resulting in a clinical improvement by at least one Rutherford category in 80.2% of the patients. Walking impairment questionnaire score, European Quality of Life index, and patient-reported pain improved significantly from baseline to 6 and 12months. Primary patency was 68.5%, freedom from target lesion revascularisation 90.6%, and amputation-free survival 83.5% at 12months. Infrapopliteal drug-coated balloon angioplasty with the ELUTAX SV DCB in patients with critical limb ischaemia was efficacious and safe over the medium term. The study is registered with Clinical.Trials.gov (Identifier: NCT02539940).

Combination of Rotarex Thrombectomy and Drug-Coated Balloon for the Treatment of Femoropopliteal Artery In-Stent Restenosis

The optimal treatment method for femoropopliteal (FP) artery in-stent restenosis (ISR) remains controversial. We assess the efficacy and safety of combination of Rotarex thrombectomy and drug-coated balloon (DCB) for the treatment of FP ISR. From June 2016 to July 2017, 32 patients with FP ISR who underwent combination of Rotarex thrombectomy and DCB angioplasty were included in a prospective registry. The primary end point was primary patency of the target lesion defined as a peak systolic velocity ratio <2.4 documented by duplex ultrasound at 12months without clinically driven target lesion revascularization (CD-TLR). The secondary outcome measure was the rate of major adverse limb events. The primary functional end point was assessed using the Walking Impairment Questionnaire (WIQ). Twenty-nine (90.6%) patients completed 12-month follow-up. Mean ankle-brachial index was 0.45±0.14 at baseline and 0.84±0.12 at 12months (P<0.05). The WIQ score was 30.45±21.14 at baseline and 52.68±29.75 at 12months (P<0.05). The Kaplan-Meier estimate of the primary patency rate at 12months was 86.2% (25/29), and freedom from CD-TLR rate at 12months was 89.7% (26/29). The data suggest that combination of Rotarex thrombectomy and DCB for treatment of FP ISR is safe and effective with satisfying primary patency rate and freedom from CD-TLR rate at 12-month follow-up.

Low Walking Impairment Questionnaire score after a recent myocardial infarction identifies patients with polyvascular disease.

ObjectivesTo evaluate whether the Walking Impairment Questionnaire score could identify patients with polyvascular disease in a population with recent myocardial infarction and their association with cardiovascular events during two-year follow-up.DesignA prospective observational study.SettingPatients admitted to the acute coronary care unit, the Department of Cardiology, Uppsala University Hospital.ParticipantsPatients admitted with acute Non-STEMI- or STEMI-elevation myocardial infarction.Main outcome measuresThe Walking Impairment Questionnaire, developed as a self-administered instrument to assess walking distance, speed, and stair climbing in patients with peripheral artery disease, predicts future cardiovascular events and mortality. Two hundred and sixty-three patients with recent myocardial infarction answered Walking Impairment Questionnaire. Polyvascular disease was defined as abnormal findings in the coronary- and carotid arteries and an abnormal ankle–brachial index. The calculated score for each of all three categories were divided into quartiles with the lowest score in first quartile.ResultsThe lowest (worst) quartile in all three Walking Impairment Questionnaire categories was associated with polyvascular disease, fully adjusted; distance, odds ratio (OR) 5.4 (95% confidence interval (CI) 1.8–16.1); speed, OR 7.4 (95% CI 1.5–36.5); stair climbing, OR 8.4 (95% CI 1.0–73.6). In stair climbing score, patients with the lowest (worst) score had a higher risk for the composite cardiovascular endpoint compared to the highest (best) score; hazard ratio 5.3 (95% CI 1.5–19.0). The adherence to medical treatment was high (between 81.7% and 99.2%).ConclusionsThe Walking Impairment Questionnaire is a simple tool to identify myocardial infarction patients with more widespread atherosclerotic disease and although well treated medically, stair climbing predicts cardiovascular events.

Venous Return Assist Devices for Intermittent Claudication: A Randomized Controlled Trial Utilizing a Sham Comparator

Objectives: To determine whether an intermittent mechanical compression device (Venowave) effects walking distance in patients with intermittent claudication as compared to placebo, as well as to review the published literature on the topic. Design: Randomized, cross-over, blinded trial of an intermittent mechanical compression device (Venowave), compared with a sham compression device. Setting: Hamilton Health Sciences, Hamilton, Canada. Participants: 27 patients with severe peripheral limb ischemia, as identified by at least one of: i) ABI<0.4; ii) ACD<200 m (Fontaine stage IIb); iii) toe-brachial index<0.5; or iv) toe pressure<40 mmHg or rest pain due to arterial ischemia. Main Outcome Measures: The primary outcome measure was Absolute Claudication Distance (ACD) while walking on a treadmill. Secondary outcome measures included Initial Claudication Distance (ICD), walk time measured in minutes, and a modified version of the Walking Impairment Questionnaire (WIQ). Results: There was no significant difference in ACD (mean difference: 14.1 m; 95% CI: -31.6 m-59.9 m; p=0.53) or ICD (mean difference: 5.9 m; 95% CI: -26.3 m-14.5 m; p=0.55) between active and sham devices. Mean walk time was identical between active and sham devices (5.6 minutes (2.1) vs. 5.6 minutes (2.0); p=0.99). The modified WIQ score was higher in the active group compared with the sham group (mean difference 2.1 m; 95% CI: 0.3 m-3.9 m; p=0.03). Conclusion: In patients with moderate to severe intermittent claudication, the Venowave device did not increase walking distance when used immediately prior to and during measured effort. This is the first study to use a sham device as a comparator in this specific context.

Effect of Rood's approach In diabetic polyneuropathy

Background: Diabetic neuropathy is the commonest complication of DM, affecting 47% patients with peripheral neuropathy. Rood’s Approach is a neurophysiological approach which is based on reflexes of central nervous system. Basic concept of Rood’s is that the motor patterns are developed from primitive reflexes through proper sensory stimuli to appropriate sensory receptors in normal sequential developmental pattern to improve motor performance. Objectives: The objectives of the study were as follows: 1. To find effect of rood’s approach in sensory abnormalities. 2. To find effect of rood’s approach in muscle weakness. Methods: Ethical clearance was obtained from the institutional ethical committee. A total of 23 diabetic neuropathy subjects were assessed and 20 were included in this study based on inclusion criteria, the individuals were allocated in one group: This group received Rood’s approach, depending upon patients’ condition either facilitatory or inhibitory techniques was given. Diabetic neuropathy was diagnosed using Michigan Neuropathy Screening Instrument Questionnaire and Pre- and post-test were done for assessing severity of diabetic neuropathy using Visual Analogue Scale (VAS), Quantitative Sensory Testing (QST) and Walking Impairment Questionnaire (WIQ) and the outcome measures were analysed after 3 months. Results: Within the group statistical analysis, Pre-Post VAS score was 6.43 ± 1.628 and was extremely significant, Pre-Post QST score was 1.900 ± 1.553 and result was extremely significant and Pre-Post WIQ score was 19.150 ± 2.978 was also significant. Conclusion: We found that facilitatory techniques of Rood’s Approach (Quick stretch and heavy joint compression) were effective in improving decreased sensations and improving motor performance in patients with painful diabetic polyneuropathy. We found that inhibitory techniques of Rood’s Approach (Maintained stretch and light joint compression) were effective in decreasing hypersensitivity in patients with painful diabetic polyneuropathy. We found significant improvement in pain measure (VAS), Sensory measure (Quantitative Sensory Testing) and Motor Performance Measure (Walking Impairment Questionnaire).