Neuromuscular Electrical Stimulation for Intermittent Claudication (NESIC): multicentre, randomized controlled trial.

METHODS: This was an open, multicentre, randomized controlled trial. Patients with intermittent claudication attending vascular surgery outpatient clinics were randomized (1:1) to receive either neuromuscular electrical stimulation (NMES) or not in addition to local standard care available at study centres (best medical therapy alone or plus supervised exercise therapy (SET)). The objective of this trial was to investigate the clinical efficacy of an NMES device in addition to local standard care in improving walking distances in patients with claudication. The primary outcome was change in absolute walking distance, measured by a standardized treadmill test at 3 months. Secondary outcomes included intermittent claudication (IC) distance, adherence, quality of life, and haemodynamic changes. RESULTS: Of 200 participants randomized, 160 were included in the primary analysis (intention to treat, Tobit regression model). The square root of absolute walking distance was analysed (due to a right-skewed distribution) and, although adjunctive NMES improved it at 3 months, no statistically significant effect was observed. SET as local standard care seemed to improve distance compared to best medical therapy at 3 months (3.29 units; 95 per cent c.i., 1.77 to 4.82; P < 0.001). Adjunctive NMES improved distance in mild claudication (2.88 units; 95 per cent c.i., 0.51 to 5.25; P = 0.02) compared to local standard care at 3 months. No serious adverse events relating to the device were reported. CONCLUSION: Supervised exercise therapy is effective and NMES may provide further benefit in mild IC.This trial was supported by a grant from the Efficacy and Mechanism Evaluation Program, a Medical Research Council and National Institute for Health and Care Research partnership. Trial registration: ISRCTN18242823.

Patients with intermittent claudication experience pain in their legs during walking or exercise which ends with rest. This severely impairs physical activity and quality of life. Treatment for such patients typically involves best medical therapy, which includes exercise advice. This study aimed to determine whether a neuromuscular electrical stimulation device improved the walking distance of patients with intermittent claudication compared to local standard care available (which may include supervised exercise therapy) in a trial. Supervised exercise improved walking distances but there was no difference in those that received a device in this patient group.

A multicenter randomized controlled study to evaluate whether neuromuscular electrical stimulation improves the absolute walking distance in patients with intermittent claudication compared with best available treatment.

OBJECTIVE: To assess the clinical efficacy of a neuromuscular electrical stimulation (NMES) device to improve the absolute walking distance in patients with intermittent claudication as an adjunct to the local standard care available at the study sites compared with local standard care alone. METHODS: This open, multicenter, randomized controlled trial included eight participating centers in England. Sites are equally distributed between those that provide supervised exercise therapy programs and those that do not. Patients with intermittent claudication meeting the eligibility criteria and providing consent will be randomized, depending on the center type, to either NMES and locally available standard care or standard care alone. The primary end point is change in absolute walking distance at 3 months (the end of the intervention period) by treadmill testing. Secondary outcomes include quality of life, compliance with the interventions, economic evaluation of the NMES device, and lower limb hemodynamic measures to further the understanding of underlying mechanisms. Recruitment commenced in March 2018 and will continue for a total of 15 months. The Neuromuscular Electrical Stimulation Improves the Absolute Walking Distance in Patients with Intermittent Claudication trial is funded by the UK Efficacy and Mechanism Evaluation Programme, Medical Research Council, and National Institute for Health Research partnership.

Case report: Inadvertent intra-arterial injection during sclerotherapy may not be the disaster you think.

OBJECTIVES: Inadvertent intra-arterial injection is a rare and serious complication of sclerotherapy. Multiple treatments have been used in reported cases, with varying levels of success. We report a rare case of intra-arterial injection being treated with steroids and pulsed dye laser therapy and present a plan for future incidences. METHOD/CASE: A 52-year-old woman presented to the clinic looking for aesthetic improvement to telangiectatic veins on the anterior aspect of the right leg. She developed cutaneous necrosis after sclerotherapy injection with 4 mL of 0.5% liquid polidocanol. RESULTS: After 23 months of pulsed dye laser therapy and a course of oral prednisolone, the patient made a good recovery and is left with minimal lasting tissue damage. CONCLUSIONS: More research is needed into the area of treating cutaneous necrosis with a pulsed dye laser, but this case report indicates a possible future therapeutic use after a successful outcome.

Clinical utility of the Covidien Closure Fast™ Endovenous Radiofrequency Ablation Catheter.

The Closure Fast™ Endovenous Radiofrequency Ablation Catheter is the latest version of a minimally invasive system for the treatment of patients with superficial venous disease. The Closure Fast™ catheter heats the vein wall to 120°C, causing denaturation of the collagen of the vein wall and contraction of the vessel such that no blood can flow through it. Nearly one million systems have been sold since the product was launched. Many, if not all, patients can be treated under local anesthesia with the Closure Fast™ catheter. Duplex ultrasound reports occlusion rates for the treated vein of 94%-98% at 1 year and 85%-93% at 3 years. The system produces average postoperative pain scores of less than 2 out of 10 on a visual analog score. In the first postoperative week, 76% of patients do not require analgesia. Some 45% of patients return to normal activity on the first postoperative day. Serious complications appear to be rare following the Closure Fast™ procedure. Transient paresthesia occurs in 0.2% of cases, thrombophlebitis in 1%-10%, and thromboembolic events in up to 1.4%, mainly heat-induced thrombosis. Closure Fast™ adds significant costs to treating superficial venous disease but studies have shown it to be cost-effective when used in an office setting.

Technique for retrieval of a knotted and entrapped guide wire after central venous catheterization.

Central venous catheterization is a common procedure performed in the critically ill patient. The complication associated with this invasive procedure is well established. However, complication related to the guide wire is rare. We present a case of knotted and entrapped guide wire following central venous catheterization using the Seldinger method and technique to retrieve it nonoperatively.

Early results with the use of heparin-bonded stent graft to rescue failed angioplasty of chronic femoropopliteal occlusive lesions: TASC D lesions have a poor outcome.

PURPOSE: To evaluate early patency rate of the heparin-bonded stent grafts in atherosclerotic long femoropopliteal occlusive disease, and to identify factors that affect outcome. METHODS: Heparin-bonded Viabahn stent grafts were placed in 33 limbs in 33 patients during 2009-2010. The stents were deployed to rescue failed conventional balloon angioplasty. Mean age was 69 (range 44-88) years, and 67 % (22 of 33) were men. Most procedures (21 of 33, 64 %) were performed for critical limb ischemia (33 % for rest pain, 30 % tissue loss). Kaplan-Meier plots and Cox regression analysis were used to identify significant risk factors. RESULTS: The average length of lesions treated was 25 ± 10 cm, and they were predominantly TASC (Transatlantic Intersociety Consensus) D (n = 13) and C (n = 17) lesions. The median primary patency was 5.0 months (95 % confidence interval 1.22-8.77). The mean secondary patency was 8.6 months (95 % confidence interval 6.82-10.42). Subsequently, 4 patients underwent bypass surgery and 5 patients underwent major amputation. One patient died. There were 5 in-stent or edge-stent stenoses. Cox multivariate regression analysis identified TASC D lesions to be a significant risk factor for early occlusion (p = 0.035). CONCLUSION: TASC D lesions of femoropopliteal occlusions have poor patency rates with the use of heparin-bonded stent grafts after failed conventional angioplasty. Alternative options should be considered for these patients.

Successful extra-anatomical recanalization of occluded superficial femoral arteries using the Outback device--a report of 2 cases.

INTRODUCTION: We report 2 cases where the Outback catheter facilitated extra-anatomical bypass after vessel perforation during attempted subintimal vessel dissection. REPORT: Attempted subintimal angioplasty of the superficial femoral artery (SFA) resulted in vessel perforation in 2 patients with chronic SFA occlusion and limb ischemia. Due to the lack of other endovascular or surgical options, the Outback catheter was used to reenter the patent lumen distal to the perforation. A stent graft was then deployed from proximal to the perforation to beyond the reentry point with successful outcomes. DISCUSSION: Although the reentry devices are typically used to enter the lumen from the subintimal plane, this novel technique involves using the Outback catheter to enter from the extravascular compartment and facilitate bypass of the SFA occlusion via an extra-anatomical route. This novel technique can be used to restore in-line blood flow when attempted endovascular revascularization failed due to vessel perforation.

Use of the Hardman index in predicting mortality in endovascular repair of ruptured abdominal aortic aneurysms.

PURPOSE: The Hardman index is a predictor of 30-day mortality after open ruptured abdominal aneurysm repair through the use of preoperative patient factors. The aim of this study was to assess the Hardman index in patients undergoing endovascular repair of ruptured aortic aneurysms. MATERIALS AND METHODS: A retrospective analysis of 95 patients undergoing emergency endovascular repairs of computed tomography-confirmed ruptured aneurysms from 1994 to 2008 in a university hospital was performed. All relevant patient variables, calculations of the Hardman index, and the incidence of 30-day mortality were collected in these patients. Correlation of the relationship between each variable and the overall score with the incidence of 30-day mortality was undertaken. RESULTS: The 24-hour mortality was 16% and 30-day mortality 36%. Increasing scores on the Hardman index showed an increasing mortality rate. Thirty-day mortality in patients with a score of 0 to 2 was 30.5%, and in those with a score of ≥3 was 69.2% (P = .01, risk ratio = 2.26, 95% confidence interval = 0.98 to 5.17). This is lower than predicted in both patient groups based on Hardman index score. Loss of consciousness was the only statistically significant independent predictor of 30-day mortality with a risk ratio of 3.16 (95% confidence interval = 2.00-4.97, P < .001). CONCLUSION: These data suggest that the Hardman index can predict an increased risk of 30-day mortality from endovascular repairs of ruptured aortic aneurysms. However, mortality from endovascular repair is much lower than would be predicted in open repair and it therefore cannot be used clinically as a tool for exclusion from intervention.

Emergency endovascular repair of aortocaval fistula--a single center experience.

PURPOSE: To review the outcomes of patients undergoing emergency endovascular repair of aortocaval fistula (ACF) secondary to abdominal aortic aneurysm (AAA). CASE REPORT: Four consecutive patients who underwent emergency endovascular repair of ACF associated with AAA in a tertiary institution between 2002 and 2009. Of the 4 patients, 3 had initially been misdiagnosed and managed for several days by other specialists for their symptoms prior to diagnosis of their ACF. Three patients died in the early postoperative period. The fourth patient made a satisfactory postoperative recovery but subsequently required further endovascular surgery to treat a persistent type 1 endoleak. CONCLUSIONS: Our experience illustrates the importance of early diagnosis and management of ACF. Even in experienced hands, the management of spontaneous ACF associated with AAA is challenging. Endovascular surgery may still have a role in improving outcomes in these patients.

The feasibility of reentry device in recanalization of TASC C and D iliac occlusions.

AIM: To determine the feasibility of subintimal angioplasty (SIA), aided by reentry device in iliac artery occlusions. METHODS: Forty-eight patients with severe claudication (Fontaine-III, n = 24) or critical limb ischaemia (Fontaine-IV, n = 24) had SIA, aided with a reentry device, for chronic iliac occlusions TASC C (n =28) and D (n = 20). The primary outcome was arterial patency at duplex follow-up. Secondary outcomes were primary failure, postprocedural complications, stent use, late occlusions, and length of hospital stay. RESULTS: The patency rate was 89% at a mean follow-up of 13 (± 11) months. There were 2 primary failures, no postprocedural complications, and 5 late occlusions. Almost 80% of patients were ready for discharge within 24 hours. CONCLUSIONS: Subintimal angioplasty with a reentry device for long iliac occlusions provides a feasible option with excellent results and short hospital stay. A randomized trial of SIA of iliac occlusion versus open reconstruction is now required.

Ruptured abdominal aortic aneurysm: endovascular repair does not confer any long-term survival advantage over open repair.

Recent studies have suggested that endovascular aneurysm repair (EVAR) may reduce the perioperative mortality of ruptured abdominal aortic aneurysm (AAA). Whether EVAR confers any long-term survival advantage over published results for open repair of ruptured AAA has not been established. We conducted a single-center retrospective study over a 10-year period (1994-2004) examining the long-term outcome of patients who have undergone endovascular repair of ruptured AAA. Fifty-four patients underwent endovascular repair of a ruptured AAA. The median age was 75 years (interquartile range 69.5-79.5 years); 42 (78%) patients were male. The perioperative mortality rate was 37%. During a median follow-up of 32 months (range 14-48 months), there were 5 aneurysm-related and 13 non-aneurysm-related deaths. Overall, the 3- and 5-year survival rates were 36% and 26%, respectively. EVAR does not appear to confer any overall survival advantage in the mid- to long term compared with the published results for open repair. The reasons for this remain unclear. Further, larger studies are required to confirm these results.

Transperitoneal laparoscopic left gonadal vein ligation can be the right treatment option for pelvic congestion symptoms secondary to nutcracker syndrome.

The nutcracker phenomenon refers to compression of the left renal vein at the origin of the superior mesenteric artery and is often underdiagnosed. This can cause symptoms of pelvic venous congestion with retrograde venous flow and a dilated gonadal vein. Here we describe a case in a 39-year-old female, who following imaging investigations to confirm the diagnosis, underwent transperitoneal laparoscopic ligation of the left gonadal vein. Laparoscopic sterilization was also performed with the aid of the gynecologists. Multiparous women, who are more likely to develop pelvic congestion symptoms, more commonly request sterilization and thus we propose that a dual laparoscopic procedure in these cases could be the treatment of choice.

Long-term renal function following endovascular aneurysm repair with infrarenal and suprarenal aortic stent-grafts.

PURPOSE: To determine in a retrospective analysis the incidence of renal impairment (RI) following endovascular repair (EVR) of abdominal aortic aneurysm (AAA), to assess the morbidity and mortality in endograft patients with preoperative RI, and to examine the impact of suprarenal stent-grafts on renal function. METHODS: From March 1994 to October 2001, 315 AAA patients (289 men; mean age 72.4+/-7.0 years) undergoing EVR were entered prospectively into a vascular registry. The patients received either an in-house custom-made stent-graft or one of several commercially made devices implanted with infrarenal or suprarenal fixation. Renal function was monitored by serum creatinine measurements prior to discharge and at 3, 6, and 12 months and annually thereafter. Preoperative RI was defined as a serum creatinine >130 micro mol/L and/or long-term dialysis. Postoperative RI referred to a >20% increase in the serum creatinine over baseline. Additional deterioration of renal function in patients with preoperative RI was referred to as postoperatively worsened RI. RESULTS: Of the 315 patients treated, 220 (69.8%) were considered high risk (ruptured AAA or ASA grade III or IV). Sixty-nine (21.9%) patients had preoperative RI (6 [1.9%] on preoperative dialysis). A suprarenal stent-graft was used in 169 (53.7%) patients and infrarenal stent-graft in the remaining 146 (46.3%). The mean follow-up was 30.1+/-22.7 months. Postoperative RI occurred in 53 (16.8%) patients (24 [7.6%] transient, 29 [9.2%] persistent). Patients with preoperative RI had a significantly higher incidence of postoperatively worsened RI (37.7% versus 11.0%, p<0.0001) and a higher mortality related to RI (7.2% versus 1.6%, p=0.02). Suprarenal fixation had no influence on the incidence of RI, on perioperative mortality, or on mortality related to RI. The only significant predictive factor of postoperative RI was preoperative RI (risk ratio 5.09, 95% CI 2.38 to 10.87, p=0.0001). CONCLUSIONS: Endovascular AAA repair may lead to persistent postoperative RI in nearly 10% of cases, especially in patients with preoperative RI. Suprarenal stent-graft fixation does not seem to have any deleterious effect on renal function. Further long-term studies are required to confirm the innocuous nature of transrenal stent placement.