Effectiveness of revascularization of the ulcerated foot in patients with diabetes and peripheral artery disease: a systematic review.

Symptoms or signs of peripheral artery disease (PAD) can be observed in up to 50% of the patients with a diabetic foot ulcer and is a risk factor for poor healing and amputation. In 2012, a multidisciplinary working group of the International Working Group on the Diabetic Foot published a systematic review on the effectiveness of revascularization of the ulcerated foot in patients with diabetes and PAD. This publication is an update of this review and now includes the results of a systematic search for therapies to revascularize the ulcerated foot in patients with diabetes and PAD from 1980 to June 2014. Only clinically relevant outcomes were assessed. The research conformed to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, and Scottish Intercollegiate Guidelines Network methodological scores were assigned. A total of 56 articles were eligible for full-text review. There were no randomized controlled trials, but there were four nonrandomized studies with a control group. The major outcomes following endovascular or open bypass surgery were broadly similar among the studies. Following open surgery, the 1-year limb salvage rates were a median of 85% (interquartile range of 80-90%), and following endovascular revascularization, these rates were 78% (70-89%). At 1-year follow-up, 60% or more of ulcers had healed following revascularization with either open bypass surgery or endovascular techniques. Studies appeared to demonstrate improved rates of limb salvage associated with revascularization compared with the results of conservatively treated patients in the literature. There were insufficient data to recommend one method of revascularization over another. There is a real need for standardized reporting of baseline demographic data, severity of disease and outcome reporting in this group of patients.

Bypass grafts: the state of the art.

The treatment options for infra-renal arteriosclerotic occlusive (ASO) vascular disease have never been more varied. The history of open revascularization procedures now exceeds 60 years. This represents three generations of vascular surgeons, the most recent of whom have witnessed more than 30 years of endovascular surgery development and dissemination. Both open and endovascular treatments should be considered mature; moreover, we are improving our understanding of the strategies and tactics that lead to the clinical application of one approach instead of the other. There are other important factors in the choice of a treatment modality to be used for a specific patient. Prime among these is evolving patterns of occlusive disease and the increasing severity of arterial calcification.

A systematic review of the effectiveness of revascularization of the ulcerated foot in patients with diabetes and peripheral arterial disease.

In several large recent observational studies, peripheral arterial disease (PAD) was present in up to 50% of the patients with a diabetic foot ulcer and was an independent risk factor for amputation. The International Working Group on the Diabetic Foot therefore established a multidisciplinary working group to evaluate the effectiveness of revascularization of the ulcerated foot in patients with diabetes and PAD. A systematic search was performed for therapies to revascularize the ulcerated foot in patients with diabetes and PAD from 1980-June 2010. Only clinically relevant outcomes were assessed. The research conformed to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, and the Scottish Intercollegiate Guidelines Network methodological scores were assigned. A total of 49 papers were eligible for full text review. There were no randomized controlled trials, but there were three nonrandomized studies with a control group. The major outcomes following endovascular or open bypass surgery were broadly similar among the studies. Following open surgery, the 1-year limb salvage rates were a median of 85% (interquartile range of 80-90%), and following endovascular revascularization, these rates were 78% (70.5-85.5%). At 1-year follow-up, 60% or more of ulcers had healed following revascularization with either open bypass surgery or endovascular revascularization. Studies appeared to demonstrate improved rates of limb salvage associated with revascularization compared with the results of medically treated patients in the literature. There were insufficient data to recommend one method of revascularization over another. There is a real need for standardized reporting of baseline demographic data, severity of disease and outcome reporting in this group of patients.

Diagnosis and treatment of peripheral arterial disease in diabetic patients with a foot ulcer. A progress report of the International Working Group on the Diabetic Foot.

The International Working Group on the Diabetic Foot (IWDGF) has produced in 2011 a guideline on the diagnosis and treatment of peripheral arterial disease in patients with diabetes and a foot ulcer. This document, together with a systematic review that provided the background information on management, was produced by a multidisciplinary working group of experts in the field and was endorsed by the IWDGF. This progress report is based on these two documents and earlier consensus texts of the IWDGF on the diagnosis and management of diabetic foot ulcers. Its aim is to give the clinician clear guidance on when and how to diagnose peripheral arterial disease in patients with diabetes and a foot ulcer and when and which treatment modalities should be considered, taking both risks and benefits into account.

Modified alpha wrap techniques for dynamic urethral graciloplasty in an animal model.

Urethral sphincter reconstruction with a stimulated skeletal muscle flap has been used for treatment of severe intrinsic sphincter deficiency. Urethral strictures and failures were reported in some of the initial experiences. The etiology of these problems is not known, but elevated resting urethral pressures and excessive urethral displacement with stimulation are possible causes. We modified two operative techniques in forming dynamic urinary graciloplasty (DUG) in an attempt to minimize resting urethral pressure without stimulation and urethral mobility during stimulation. Two types of DUG were used. In the first group, a small flap (partial muscle wrap) from the gracilis muscle with an attachment site on the muscle was constructed in four dogs. In the second group, three dogs with a modified alpha wrap and proximal attachments were used. All of the gracilis muscle wraps were stimulated using an implanted programmable pulse stimulator with electrodes attached over the motor nerve. Following a 2-week, postrecovery period, urethral pressure measurements were obtained with and without stimulation. Five weeks were used for stimulation to condition the muscle. This was followed by 4 weeks of continuous stimulation. Thus, devices were implanted for 11 weeks. Before conditioning of the muscles was initiated, the partial muscle wrap pressure at rest was 42 +/- 27 cm H2O, which was higher than the incomplete alpha wrap resting pressure of 20 +/- 4 cm H2O. Stimulated partial flap pressure was 161 +/- 50 cm H2O, and stimulated modified alpha wrap pressures was 71 +/- 27 cm H2O. After conditioning with the modified alpha wrap, the resting and stimulated pressures were unchanged from before conditioning. Technical problems precluded collection of data during the conditioning period in dogs with partial flaps. During stimulation, the partial muscle wrap demonstrated marked deviation, whereas the modified alpha wrap had minimal urethral movement. Postmortem evaluation indicated no urethral stricture or fistula formation with either of the two types of wraps. The modified alpha wrap had several positive features. Advantages over the partial wrap were minimal resting pressures, reduced urethral mobility, and adequate sustained pressures during stimulation. Therefore, in contrast to the partial gracilis muscle wrap, aspects of the incomplete alpha wrap should be considered further for DUG.

Home bladder pressure monitoring in children with myelomeningocele.

PURPOSE: We evaluate a pressure gauge used at home for patients with myelomeningocele on clean intermittent catheterization to provide a system for inexpensive frequent monitoring of bladder pressures. MATERIALS AND METHODS: Subjects with myelomeningocele using clean intermittent catheterization underwent cystometry in the laboratory. At home they obtained weekly volumes and bladder pressures before and after emptying. Home estimate of detrusor pressure was defined as full bladder pressure minus empty bladder pressure. Medication changes, subject position and urinary tract symptoms were noted. RESULTS: A total of 11 subjects 10.5+/-7.3 years old have been enrolled and have made 16.7+/-12.6 weekly home bladder pressure and volume recordings in 4.7+/-3.1 months. Bladder capacities measured at home were 132+/-47% of cystometric capacities. At volumes of data overlap home full pressures (31+/-10 cm. water) were not statistically different from cystometric vesical pressures (25+/-9 cm. water). Home empty pressures (7+/-4 cm. water) were similar to cystometric abdominal pressures (14+/-8 cm. water). Home estimates of detrusor pressures (23+/-7 cm. water) magnified differences in full and empty pressures, and were significantly greater than cystometric detrusor pressures (11+/-11 cm. water). In 2 subjects significant increases in home full pressures occurred, which were associated with cessation of anticholinergic medication and infection. CONCLUSIONS: Home monitoring of bladder pressure is a simple, inexpensive and accurate method of obtaining frequent bladder pressures in patients with myelomeningocele. These pressures are consistent over a large range of volumes and times, and could potentially be used to identify quickly changes in patient condition.

Urodynamic verification of noninvasive back-pressure recordings from the urinary bladder.

Obstructive voiding is best evaluated with urodynamics, especially simultaneous measurement of bladder-pressure and urine flow rates. As an alternative to catheterization for urodynamics, noninvasive back-pressure methods using an external condom system have been introduced. This device uses one side tube in the condom for pressure recording and an outlet tube that is clamped for short periods of time during voiding. However, there have been problems with accurate back-pressure recording, including leaking, clamping techniques, hydrostatic pressures associated with pressure recording below the level of the symphysis pubis, and assessment of back pressures in relation to bladder and detrusor pressures. To address these issues, we have modified the condom for passing a catheter into the urethra for simultaneous direct bladder and back-pressure recording. The clamping device on the outlet tube also has been modified to produce back flushing of urine in addition to clamping. Hydrostatic issues have been addressed by making pressure recordings at the level of the symphysis pubis. Seven patients with obstructive symptoms were evaluated using these new devices. Back pressures were not statistically different than detrusor pressures recorded with a urethral catheter. Thus, the modifications have improved back-pressure recording techniques. The use of noninvasive back-pressure recording may be an important adjunct in the evaluation of obstructive uropathy.

Management considerations for treating vesicoureteral reflux in children with solitary kidneys.

OBJECTIVES: To evaluate the management approach for vesicoureteral reflux (reflux) into a solitary kidney. METHODS: Outcomes of all children with solitary kidneys and reflux managed between 1981 and 1996 were reviewed. Solitary kidneys were documented by nuclear renography and ultrasonography; reflux was graded after cystography. Management consisted of observation and antimicrobial prophylaxis or surgery by ureteroneocystostomy or subureteric injection of polytetrafluoroethylene (STING). Follow-up ranged from 3 months to 14 years and included serial cystography, sonography, and serum creatinine measurement. RESULTS: Twenty-one patients with a median follow-up of 26 months were identified. Etiologies included contralateral renal agenesis (14 children), multicystic dysplastic kidney (5 children), or nonfunctioning ureteropelvic junction obstruction (2 children). Low-grade (I to II) reflux was identified in 6 children, and high grade (III to V) was identified in 15. Reflux resolved in 20 patients. Five children with low-grade reflux were managed without surgery and demonstrated reflux resolution after a mean of 20.5 months. Renal function deteriorated in only 1 child. Ureteroneocystostomy was performed in 13 children with grades III to V reflux, and STING was performed in 1 child with grade II reflux. Every surgical patient maintained stable renal function and was infection-free during a mean follow-up of 56 months. Management by observation in 2 children with grades IV to V reflux resulted in spontaneous resolution in one and stable grade IV in the other. CONCLUSIONS: Reflux into the solitary functioning kidney may be managed by the same strategies used to manage unilateral reflux in children with two normally functioning kidneys: low-grade reflux by observation/ chemoprophylaxis until spontaneous resolution occurs, and higher grades by surgery to protect renal function; however, chemoprophylaxis and serial imaging may be used until well-defined indications for surgery are satisfied. Renal function should be monitored diligently.

Management of arterial occlusive disease following radiation therapy.

Clinically significant arterial occlusive disease developed in 26 patients at between 5 months and 44 years (mean(s.d.) 10.7(12.0) years) following radiation therapy. Therapeutic radiation was associated with lesions of the carotid artery (nine patients), subclavian-axillary arteries (seven) and the abdominal aorta and its branches (10). Clinical presentations included transient ischemic attack, stroke, vertebrobasilar insufficiency, carotid bruit, upper- or lower-extremity ischemia and renovascular hypertension. Surgery for cerebrovascular insufficiency included carotid endarterectomy with vein patch, interposition grafting or subclavian-to-carotid bypass. Carotid or subclavian-to-axillary bypass was performed for upper-extremity ischemia. A combination of endarterectomy and Dacron or saphenous vein grafts was used for infrarenal reconstruction. Tunnels were placed orthotopically. Musculocutaneous flaps assisted in healing selected wounds. Ureteral catheters were useful adjuncts in abdominal vascular reconstructions. There were no operative deaths, strokes or amputations. One patient had recurrent transient ischemic attacks following subclavian-to-carotid bypass. The mean(s.d.) postoperative follow-up was 48.1(39.6) months. Patients presenting with end-organ ischemia following radiation therapy can be managed successfully with aggressive surgical revascularization using a broad spectrum of reconstructive techniques.

Preoperative assessment of alternative veins.

Duplex ultrasonography, with or without color flow, has replaced phlebography as the technique of choice to select veins for autogenous bypass grafts. Although anatomic location and length are well-defined by ultrasound, evaluation of the venous wall itself is still imperfect. In situ diameters are less than those of arterialized veins. Ultrasonic search is most valuable in the examination of patients with good veins obscured by a layer of fat. Preoperative knowledge of variant anatomy and location of major veins and their branches facilitates bypass surgery. The preoperative vein mapping should be available in the operating room to guide the placement of incisions for unroofing and exploration directly over veins and vein segments that have a high likelihood of being usable. The finding of a useful vein when none is apparent on physical examination may enable the construction of an autogenous bypass in lieu of a less desirable prosthetic graft or leg amputation.

Bypass grafts to the ankle and foot. A personal perspective.

Our experience and that of others indicate that the number of very distal bypass operations is growing. From the early 1970s, when we performed a few operations per year, our numbers have increased to 60 to 65 operations annually, about 20% of all infrainguinal open revascularizations. Amputation of one leg leaves a patient, should he survive for a few years, with a second limb that is at substantial risk of infection or gangrene. From over 20 years of experience with thousands of diabetic leg problems and approximately 600 paramalleolar bypasses, the following facts have emerged from our clinical practice. Primary pedal arterial arches are virtually never complete. This alone should not deter the surgeon from attempting paramalleolar bypass grafting. Clinical details such as neuropathy, sepsis, and general medical status and even family support should not be overlooked as "risk factors." The order of frequency for pedal distal anastomotic sites will be anterior tibial/dorsalis pedis, posterior tibial/common plantar artery, lateral plantar artery/medial plantar artery, and lateral tarsal artery. In each case the graft should be placed as proximal as possible on the vessel; tibial outflow should be considered. Use short grafts with distal inflow whenever possible. In the rare instance wherein no pedal target site is available, consider the isolated tibial segment. Failure of a very distal bypass procedure seldom results in an amputation that is more proximal than otherwise would have been required if no bypass were attempted. As a corollary, after sepsis is controlled and all lesions and amputations are healed, failure of the graft may spare the limb from further risk of amputation. In diabetics, the presence of a palpable popliteal pulse and absence of foot pulse are tantamount to identifying the paramalleolar bypass graft candidate. Even the presence of palpable pedal pulses does not exclude patients who could achieve limb salvage with pedal bypass. That determination depends upon an angiogram. Pulsation and flow are not equivalent. Just as the obligations of the surgeon who performs an amputation are not discharged until healing and rehabilitation are complete, likewise, the vascular surgeon's duties after paramalleolar bypass must include a return to the ambulatory status. Careful follow-up, ongoing explicit patient and family education about foot care, and orthotics and shoes will enhance the life and life expectancy of the bipedal patient.

Subclavian artery catheterization: a new approach for endovascular procedures.

PURPOSE: Percutaneous access to the arterial system for endovascular procedures is usually achieved through the femoral arteries. When femoral access is precluded, the axillary or brachial arteries serve as alternatives. Complications associated with the use of the latter arteries have led us to develop subclavian arterial catheterization. METHODS AND RESULTS: From 1978 to 1993, 569 patients underwent angiography via the subclavian artery (> 99% left subclavian artery); 134 were studies of the aortic arch and brachiocephalic vessels; 435 studies involved the descending and abdominal aorta and its branches and runoff. Coronary arteriography was also feasible. Since 1986, 44 patients have undergone endovascular procedures: 33 percutaneous transluminal angioplasties of the visceral, iliac, femoral, and popliteal arteries and 11 thrombolytic procedures of aortofemoral graft limbs (n = 3) and femoral distal bypasses (n = 8) were performed. Complications (1.2%) included partial pneumothorax (n = 2), hemorrhage requiring operative control (n = 2), causalgia (n = 1) and embolization (n = 2). CONCLUSIONS: Whenever percutaneous femoral catheterization cannot be achieved or an alternate access point is indicated, we select the subclavian approach as an alternative to axillary, brachial or translumbar access. It is safe, expeditious, and versatile for virtually all types of systemic and cardiac catheterization; it is also applicable to thrombolysis and balloon angioplasty.

Allograft vein bypass: is it an acceptable alternative for infrapopliteal revascularization?

PURPOSE: Autogenous vein bypass grafts to infrapopliteal outflow sites have patency and limb salvage rates significantly superior to those obtained with prosthetic grafts. However, when infrageniculate bypass is required for limb-threatening ischemia in the patient lacking suitable autogenous veins, nonautogenous reconstruction or primary amputation are the only other alternatives. METHODS: During a 2-year period we implanted 25 cryopreserved allograft saphenous vein bypass grafts in 24 patients (median age 76 years) with tissue necrosis (20 patients), rest pain (4 patients), or acute ischemia (1 patient); 16 patients were men and 8 were women. As many as six previous revascularizations were performed in 79%; two grafts extended to the infrageniculate popliteal artery; 23 grafts extended to a paramalleolar vessel. RESULTS: Secondary patency at 1 month was 87%, but only 36% at 1 year. Use of warfarin (Coumadin) failed to improve the patency rate (five of nine occlusions treated with Coumadin versus eight of 16 not treated with Coumadin). Only eight of 24 patients are alive with open grafts; nine patients have died. CONCLUSIONS: Unheralded occlusions more typical of prosthetic graft failure tempered the initial enthusiasm and effectiveness of vein allografts. All autogenous options must be exhausted to complete distal, secondary revascularization before resorting to nonautogenous conduits. Use of allograft veins must be viewed with continued skepticism.

Salmonella infections of the abdominal aorta.

Salmonella accounts for up to one-third of all primary abdominal aortic infections. During the past ten years, we have treated three patients with this disease and have reviewed an additional 61 instances found in the English literature. The overall survival rate was 46 percent. Fever and back or abdominal pain were present in more than 90 percent of the patients, while a pulsatile mass was present in only 42 percent of those reported. Blood cultures were positive in 73 percent of patients. Computed tomography and angiography were helpful in delineating the presence of aneurysms and defining the extent. Twenty-two patients were treated without undergoing aortic resection; there were no survivors. One patient had an aortic resection without reconstruction and survived. Twenty-eight patients were treated with aortic resection and anatomic reconstruction. Six patients in this group died of graft sepsis and an additional six patients required graft removal for persistent infection. In contrast, 18 of 19 patients treated with extra-anatomic grafting and aneurysm resection survived, with only one death from aortic stump sepsis. No patient has required graft removal for sepsis. These results suggest that aneurysm resection and extra-anatomic bypass is the treatment of choice in patients with Salmonella infections involving the infrarenal aorta.