Abstract Background Lower extremity peripheral arterial disease (LE-PAD) reduces walking capacity and is associated with an increased cardiovascular risk. Endovascular revascularization of LE-PAD ...improves walking performance and quality of life. In the present study, we determined whether successful lower limbs revascularization also impacts cardiovascular outcome in LE-PAD patients. Methods 479 consecutive LE-PAD patients at stage II of Fontaine's classification, with ankle/brachial index ≤ 0.90 and one or more stenosis > 50% in at least one leg artery, were enrolled in the study. According to the Trans-Atlantic Inter Society Consensus II recommendations, 264 (55.1%) underwent percutaneous lower extremity angioplasty (PTA group), while 215 (44.9%) were managed with conservative therapy (MT group). The incidence of major cardiovascular events (including cardiovascular death, myocardial infarction, ischemic stroke, coronary and carotid revascularizations) was prospectively analyzed by Kaplan–Meier curves. Crude and adjusted HRs (95% CI) of developing a cardiovascular event were calculated by Cox analysis. Results No baseline differences were observed among the groups, except for a lower maximum walking distance in the PTA group. During a median follow-up of 21 months (12.0–29.0), the incidence of cardiovascular events was markedly lower in PTA compared to MT patients (6.4% vs. 16.3%; p = 0.003), and patients in the MT group showed a 4.1-fold increased cardiovascular risk compared to patients in the PTA group, after adjustment for potential confounders (95% CI 1.22–13.57, p = 0.023). Conclusions This study shows that successful revascularization of LE-PAD patients affected by intermittent claudication, in addition to improving functional status, reduces the occurrence of future major cardiovascular events.
The purpose of this study was to assess long-term outcomes of a 6-week multimodal program (manual therapy, exercises, and self-management strategies) in patients with neurogenic claudication due to ...degenerative lumbar spinal stenosis.
This study evaluated 49 patients with neurogenic claudication who completed a 6-week multimodal program between 2010 and 2013. Outcomes included Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and Numeric Rating Scale. Mean differences, paired t tests, and the Wilcoxon rank-sum test were used to compare outcomes at baseline, 6 weeks, and long-term follow-up.
Twenty-three patients completed the follow-up questionnaire (47% response rate). Median follow-up was 3.6 years (interquartile range: 3.3-4.6). The mean age was 73.5 years (standard deviation: 8.5). Between baseline and long-term follow-up, there were statistically significant and clinically important improvements in disability (ODI: -23.7 95% confidence interval (CI): -15.7 to -31.6; ODI walking item: -1.96 95% CI: -1.34 to -2.57; ZCQ function scale: -0.42 95% CI: -0.10 to -0.70) and pain (leg pain: -3.53 95% CI: -1.80 to -5.20; ZCQ symptom scale: -0.71 95% CI: -0.30 to -1.10), but not low back pain (Numeric Rating Scale: -1.03 95% CI: -1.00 to 3.10). There was no statistically significant change in any outcomes between 6 weeks and long-term follow-up.
In a sample of patients with neurogenic claudication participating in a 6-week multimodal program, clinically important improvements in leg pain and disability, but not low back pain while walking, were maintained in the long term (median duration of 3.6 years) when compared to baseline.
Intermittent claudication is the primary symptom of peripheral arterial disease, affecting between 1 and 3 million Americans. Symptomatic improvement can be achieved by endovascular ...revascularization, but such procedures are invasive, expensive, and may be associated with procedural adverse events. Medical treatment options, including claudication medications and supervised exercise training, are also known to be effective, albeit also with associated limitations. The CLEVER (Claudication: Exercise Vs. Endoluminal Revascularization) study, funded by the Heart, Lung, and Blood Institute of the National Institutes of Health, is a prospective, multicenter, randomized, controlled clinical trial evaluating the relative efficacy, safety, and health economic impact of four treatment strategies for people with aortoiliac peripheral arterial disease and claudication. The treatment arms are: (1) optimal medical care (claudication pharmacotherapy); (2) primary stent placement; (3) supervised exercise rehabilitation; and (4) combined stenting with supervised exercise rehabilitation. The CLEVER study is a 5-year randomized, controlled clinical trial to be conducted at approximately 25 centers in the United States that will monitor 252 patients and their responses to treatment during an 18-month follow-up period. The primary end point is change in maximum walking duration on a graded treadmill test. Secondary end points include the change at 18 months in maximum walking duration from baseline, comparisons of free-living daily activity levels assessed by pedometer, health-related quality of life, and cost-effectiveness. Other analyses include the effect of these treatment strategies on anthropomorphic and physiologic variables, including body mass index, waist circumference, blood pressure, pulse pressure, and resting pulse as well as biochemical markers of cardiovascular health, including fasting lipids, fibrinogen, C-reactive protein, and hemoglobin A1c values.
The role of common femoral artery endarterectomy (CFE) and the need for distal revascularization is challenging in certain clinical scenarios. For some patients with claudication or rest pain CFE ...alone may suffice, however, some surgeons advocated that in-line flow must be re-established in patients with major tissue loss for wound healing purposes. The decision when to perform CFE with or without distal revascularization is sometimes difficult. The objective of this study was to evaluate the outcomes of common femoral artery endarterectomy (CFE) to define predictive factors for additional distal revascularization.
Retrospective review of 262 consecutive CFEs in 230 patients with lower-extremity ischemia between 1997 and 2008. Patients were divided into two groups: group A (n = 169; CFE alone) and group B (n = 93; CFE + distal revascularization). Concomitant iliac intervention was included only if performed by endovascular approach. Patients were analyzed by Rutherford category (RC) and TransAtlantic InterSociety Consensus (TASC) II classification. Primary end points were mortality, patency, reintervention, and limb salvage.
Demographics, preoperative Society for Vascular Surgery score assessment, and TASC II classification did not differ between groups. Mean follow-up was 75 months (range: 1-128 months). Technical success was obtained in all patients. RC (3 ± 1.2 vs. 5 ± 1.4; P = 0.001), diabetes (33% vs. 52%; P = 0.005), mean operative time (+154 minutes; P < 0.001), and length of hospital stay (+1.7 days; P = 0.03) were higher in group B. Reintervention rates were higher in group B than group A (12% vs. 3%; P = 0.015). For patients with RC 5/TASC D lesions and patients with RC 6 regardless of TASC, initial distal revascularization (group B) was associated with fewer reinterventions or major amputations (29%) than CFE alone (67%) (P = 0.002). The cumulative 5-year primary patencies for groups A and group B were 96% and 92%, respectively. Secondary patency was 100% at both time points. Limb salvage was also lower in patients with RC 5 and 6 (P = 0.01; P = 0.02). Overall survival was 93% at 1 year and 77% at 5 years. Independent predictors for distal revascularization were RC 5 or 6 (P < 0.001), TASC D lesions (P < 0.0001), diabetes (P = 0.04), and being on anticoagulation (P = 0.003). There was no difference in survival between the two groups for RC 1 to 5 (P = 0.2), but for patients with RC 6, survival was improved in group B (39% vs. 67%; P = 0.9).
CFE alone is sufficient for patients with lower-extremity ischemia who present with life-limiting claudication regardless of TASC lesion and for those with RC 5 and TASC lesions A to C. Patients with RC 5 and TASC D lesions and those with major tissue loss (RC 6) regardless of TASC lesion are better served with additional distal revascularization to improve limb salvage, reintervention, and survival rates.
To compare drug (paclitaxel)-coated balloon angioplasty with femoropopliteal bypass surgery in the treatment of femoropopliteal lesions.
A retrospective study was performed between January 2015 and ...January 2019, covering a four-year period. All subjects who underwent femoropopliteal bypass surgery and drug-coated balloon angioplasty over a four-year period were evaluated. The subjects' demographic characteristics, lesion characteristics, treatment outcomes and disease-free survival were collected. Subjects were divided into the femoropopliteal bypass group (Group A) and the drug-coated balloon angioplasty (Group B) group.
In total, 220 subjects were enrolled. Both Group A and Group B consisted of 110 subjects. The proportion of patients with a claudication distance between 0 and 50 m was significantly higher in Group A, and the proportion of patients with a claudication distance between 50 and 100 m was significantly higher in Group B (
= 0.001). In terms of the Rutherford levels, moderate claudication was significantly higher in Group B, and severe claudication was significantly higher in Group A (
= 0.001). The lesion length for the subjects in Group A was significantly longer than that in Group B (24.61 ± 2.79 mm for Group A and 18.59 ± 3.95 mm for Group B,
= 0.001). The stenosis degree in Group A was also significantly higher than that in Group B (96.82 ± 4.32% for Group A and 94.85 ± 4.55% for Group B,
= 0.001). The duration of the procedure, duration of hospitalization and rate of bleeding in Group A were significantly higher than those in Group B. The incidence of overall morbidity and reintervention rates in Group B were significantly higher than that in Group A. The preoperative ankle brachial index values of the subjects in Group B were statistically significantly higher than those in Group A (0.56 ± 0.08 for Group A and 0.61 ± 0.08 for Group B,
= 0.001). The change in the ankle brachial index measurement of the subjects in Group A with respect to the preprocedure value was significantly greater than that in Group B (
= 0.001). For primary patency, there was a significant difference between the groups in the distribution of the duplex ultrasound results at the 3rd, 6th, 9th and 12th month control points (
= 0.001). At all control points, Group A had better primary patency rates, whereas the secondary patency rates did not differ. In total, among the 220 patients, 125 (56.8%) were disease free, and 95 (43.2%) experienced recurrence. The mean disease-free survival times for Group A and Group B were 10.45 ± 0.28 months and 9.11 ± 0.37 months, respectively. The disease-free survival rates were significantly higher in Group A (
= 0.001,
< 0.05).
Femoropopliteal bypass resulted in better disease-free survival rates than drug-coated balloon angioplasty and serves as an effective modality for the treatment of femoropopliteal lesions.
Opiate use, dependence, and the associated morbidity and mortality are major current public health problems in the United States. Little is known about patterns of opioid use in patients with ...peripheral arterial disease (PAD). The purpose of this study was to identify the prevalence of chronic preoperative and postoperative prescription opioid use in patients with PAD. A secondary aim was to determine the demographic, comorbid conditions, and operative characteristics associated with chronic opioid use.
Using a single-institution database of patients with PAD undergoing open or endovascular lower extremity intervention from 2013 to 2014, data regarding opiate use and associated conditions were abstracted for analysis. Patients were excluded if they did not live in North Carolina or surgery was not for PAD. Preoperative (PreCOU) and postoperative chronic opioid use (PostCOU) were defined as consistent opioid prescription filling in the 3 months before and after the index procedure, respectively. Opioid prescription filling was assessed using the North Carolina Controlled Substance Reporting System. Demographics, comorbid conditions, other adjunct pain medication data, and operative characteristics were abstracted from our institutional electronic medical record. Associations with PreCOU were evaluated using the t test, Wilcoxon test, or two-sample median test (continuous), or the χ2 or Fisher exact tests (categorical).
A total of 202 patients undergoing open (108; 53.5%) or endovascular (94; 46.5%) revascularization for claudication or critical limb ischemia were identified for analysis. The mean age was 64.6 years, and 36% were female. Claudication was the indication for revascularization in 26.7% of patients, and critical limb ischemia was the indication in 73.3% of patients. The median preoperative ankle-brachial index (ABI) was 0.50. Sixty-eight patients (34%) met the definition for PreCOU. PreCOU was associated with female gender, history of chronic musculoskeletal pain, benzodiazepine use, and self-reported illicit drug use. Less than 50% of patients reported use of non-opiate adjunct pain medications. No association was observed between PreCOU and pre- or postoperative ABI, or number of prior lower extremity interventions. Following revascularization, the median ABI was 0.88. PreCOU was not associated with significant differences in postoperative complications, length of stay, or mortality. Overall, 71 patients (35%) met the definition for PostCOU, 14 of whom had no history of preoperative chronic opiate use. Ten patients with PreCOU did not demonstrate PostCOU.
Chronic opiate use was common in patients with PAD with a prevalence of approximately 35%, both prior to and following revascularization. Revascularization was associated with a termination of chronic opiate use in less than 15% of patients with PreCOU. Additionally, 10% of patients who did not use opiates chronically before their revascularization did so afterwards. Patients with PAD requiring intervention represent a high-risk group with regards to chronic opiate use. Increased diligence in identifying opioid use among patients with PAD and optimizing the use of non-narcotic adjunct pain medications may result in a lower prevalence of chronic opiate use and its attendant adverse effects.
Opioid use is common among patients with peripheral arterial disease (PAD), given that pain is a defining symptom. Unfortunately, long-term opioid use places patients at dramatically increased risk ...of overdose and death. Although surgical revascularization is extremely effective in alleviating ischemic pain related to PAD, it is unclear whether this practice results in the discontinuation of opioids after surgery. Therefore, we conducted the following study to investigate trends in opioid use before and after surgical bypass in patients with PAD, as well as the risk factors for continued opioid use after surgery.
We conducted a retrospective analysis of patients undergoing open lower extremity bypass for claudication or rest pain between June 1, 2017, and March 31, 2021. Patients were grouped according to whether they reported preoperative opioid use at the time of surgery. The primary outcome was continued opioid use at 30-day follow-up after discharge. A multivariable logistic regression was conducted to estimate the association of continued opioid use with patient characteristics, preoperative opioid use, and receiving a postoperative opioid prescription.
Among 3873 patients undergoing surgery, the mean age was 65.7 (10.2) years and 2650 (68.4%) patients were male. There were 913 patients (23.6%) who used opioids preoperatively and hydrocodone was the most common preoperative opioid (583 63.9%). At discharge, 2506 patients (64.7%) received a postoperative opioid prescription. Postoperative opioid prescriptions were significantly more common for preoperative opioid users than opioid-naïve patients (813 89.0% vs 1693 57.2%; P < .001) and were significantly larger in size (24.3 21.1 pills vs 19.9 10.5 pills; P < .001). On 30-day follow-up, 522 preoperative opioid users (61.3%) and 616 opioid-naïve patients (28.4%) reported that they were still using opioids (P < .001). Continued opioid use at follow-up was associated with preoperative opioid use (adjusted odds ratio, 3.23; 95% confidence interval, 2.70-3.89) and receiving a postoperative opioid prescription (adjusted odds ratio, 10.83; 95% confidence interval, 7.96-15.06).
Most patients with PAD who use opioids preoperatively do not discontinue opioids after lower extremity bypass. Moreover, a significant proportion of previously opioid-naïve patients are still using opioids 1 month after surgery. In both cases, postoperative opioid prescriptions had the strongest association with continued opioid use. These findings underscore the need for improved prescribing practice and increased attentiveness to discontinuation of unnecessary medications after surgery.
Six-min walking test (6MWT) has been widely in patients with symptomatic peripheral artery disease (PAD) to quantify the walking impairment and the efficacy of different therapeutic interventions. ...Despite the aforementioned usefulness of 6MWT for PAD, the information provided by this test goes beyond the meters walked. The aim of this study was to describe the relative values of 6MWT and body weight-walking distance product (DW) in patients with symptomatic PAD.
Two hundred twenty-seven patients with symptomatic PAD participated in the study. The 6MWT was performed and absolute and claudication distances were obtained. The results of 6MWT were then relativized and expressed as a percentage of a healthy subject. DW was obtained by the product of 6MWT distance by weight. In both sexes, the relative 6MWT ranged from 57% to 64%.
Absolute 6MWT total distance (P < 0.001) was lower in women than in men, whereas the relative 6MWT total distance was similar between sexes (P = 0.398). The absolute and relative 6MWT total distance were similar among age categories (P > 0.072). The DW was higher in men than in women (P < 0.05). In addition, in women, DW was higher in younger group than in other age groups (P < 0.05).
Patients with symptomatic PAD achieve less than 70% of the distance achieved by an age-matched healthy subject. In patients with symptomatic PAD, the relative values of 6MWT total distance are similar between sexes and among different age groups, whereas DW are influenced by age and sex.
To compare antegrade versus retrograde recanalization, in terms of procedural time, radiation and contrast agent exposure, number and total length of implanted stents and procedural complications, in ...long and calcified, de novo femoropopliteal occlusions. We performed retrospective matching of prospectively acquired data by lesion length, occlusion length and lesion calcification by the peripheral arterial calcium scoring system (PACSS) score in patients who were referred for endovascular treatment due to symptomatic peripheral artery disease (PAD). Forty-two consecutive patients with antegrade and 23 patients with retrograde after failed antegrade recanalization were identified (mean lesion length = 32.1 ± 6.9 cm; mean occlusion length = 24.6 ± 7.7 cm; PACSS score = 3.25 ± 0.91). 23% of the patients had intermittent claudication, whereas 77% exhibited critical limb ischemia (CLI). Patients who underwent retrograde versus antegrade recanalization required a significantly lower number of stents (0.9 ± 1.0 versus 1.8 ± 1.4,
p
= 0.01) and a lower total stent length (6.8 ± 8.5 cm versus 11.7 ± 9.9 cm,
p
< 0.05) in the interest of more extensive coverage of the lesions using drug coated balloons (DCB) (28.5 ± 12.0 cm versus 18.2 ± 16.0 cm,
p
= 0.01). No re-entry device was required with the retrograde versus 9 of 42 (21%) with the antegrade recanalization group (
p
= 0.02). The rate of complications due to retrograde puncture was low (one patient with hematoma and one with distal pseudoaneurysm, both managed conservatively). In long and calcified femoropopliteal occlusions, the retrograde approach is associated with a lower number of re-entry devices and stents and with more extensive lesion coverage with DCB, in the interest of costs and possibly long-term patency.
German Clinical Trials Register
: DRKS00015277.
To evaluate the efficacy of percutaneous transluminal angioplasty (PTA) of atherosclerotic lesions of the common femoral artery (CFA) and its bifurcation.
From 2009 to 2013, 53 patients (43 men, ...average age, 68 years) were included in a single-center, nonrandomized, prospective study. Indication was disabling intermittent claudication (n = 36) or chronic critical limb ischemia (n = 17). Thirty-four procedures (64%) were isolated CFA PTA, whereas 7 of 53 (13%) involved inflow (including 4 iliac occlusions) and 12 of 53 (23%) involved outflow vessels. Primary stenting was performed in 50 cases (95%). CFA occlusions were recanalized in 4 of 53. Lesions involved the bifurcation in 22 cases (40%). Follow-up consisted of clinical examination and duplex scanning with ankle-brachial index measurement at 1, 6, and 12 months. A biplane X-ray was performed at 1 year. The primary end point was the absence of binary restenosis (>50% reobstruction of the CFA). Secondary end points were freedom from target lesion revascularization (TLR) and stent fracture rate.
Procedural success was achieved in 96% of cases. At a mean follow-up of 24 months (with 1 patient lost of follow-up), the absence of binary restenosis was 92.5%. At the end of follow-up, 82% of patients continued to show clinical improvement. Freedom from TLR was 97%. Stent fracture rate at 1 year was 9%.
PTA of the CFA and its bifurcation is a reliable technique with good midterm functional results. These results justify performing a randomized study comparing surgery and endovascular treatment.
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