Review of the literature supporting international clinical practice guidelines on iliac venous stenting and their applicability to Australia and New Zealand practice.

BACKGROUND: The overall goal of this report is to provide a high-level, practical approach to managing venous outflow obstruction (VOO). METHODS: A group of vascular surgeons from Australia and New Zealand with specific interest, training, and experience in the management of VOO were surveyed to assess current local practices. The results were analyzed and areas of disagreement identified. After this, the group performed a literature review of consensus guidelines published by leading international organizations focused on the management of chronic venous disease, namely, the Society for Vascular Surgery, American Venous Forum, European Society for Vascular Surgery, American Vein and Lymphatic Society, Cardiovascular and Interventional Radiology Society of Europe, and American Heart Association. These guidelines were compared against the consensus statements obtained through the surveys to determine how they relate to Australian and New Zealand practice. In addition, selected key studies, reviews, and meta-analyses on venous stenting were discussed and added to the document. A selection of statements with >75% agreement was voted on, and barriers to the guideline's applicability were identified. The final recommendations were further reviewed and endorsed by another group of venous experts. RESULTS: The document addresses two key areas: patient selection and technical aspects of venous stenting. Regarding patient selection, patients with clinically relevant VOO, a Clinical-Etiologic-Anatomic-Physiologic score of ≥3 or a Venous Clinical Severity Score for pain of ≥2, or both, including venous claudication, with evidence of >50% stenosis should be considered for venous stenting (Level of Recommendation Ib). Patients with chronic pelvic pain, deep dyspareunia, postcoital pain affecting their quality of life, when other causes have been ruled out, should also be considered for venous stenting (Level of Recommendation Ic). Asymptomatic patients should not be offered venous stenting (Level of Recommendation IIIc). Patients undergoing thrombus removal for acute iliofemoral deep vein thrombosis, in whom a culprit stenotic lesion of >50% has been uncovered, should be considered for venous stenting (Level of Recommendation Ib). CONCLUSIONS: Patients with VOO have been underdiagnosed and undertreated for decades; however, in recent years, interest from physicians and industry has grown substantially. International guidelines aimed at developing standards of care to avoid undertreating and overtreating patients are applicable to Australia and New Zealand practice and will serve as an educational platform for future developments.

RETRACTED: Australian and New Zealand Society for Vascular Surgery clinical practice guidelines on venous outflow Obstruction of the femoral-iliocaval veins.

BACKGROUND: The overall goal of this report is to provide a high-level, practical approach to managing venous outflow obstruction (VOO) in Australia and New Zealand. METHODS: A group of vascular surgeons from the Australian and New Zealand Society for Vascular Surgery with specific interest, training, and experience in the management of VOO were surveyed to assess current local practice. The results were analyzed and areas of disagreement identified. Following this, the group performed a literature review of consensus guidelines published by leading international organizations focused on the management of chronic venous disease, namely the Society for Vascular Surgery, American Venous Forum, European Society for Vascular Surgery, American Vein and Lymphatic Society, Cardiovascular and Interventional Radiology Society of Europe, and American Heart Association. These guidelines were compared against the consensus statements obtained through the surveys to determine how they relate to Australian and New Zealand practice. In addition, selected key studies, reviews, and meta-analyses on venous stenting were discussed and added to the document. Finally, a selection of statements with >75% agreement was voted on, and barriers to the guideline's applicability were identified. RESULTS: The document addresses two key areas: patient selection and technical aspects of venous stenting. Regarding patient selection, patients with a CEAP (Clinical-Etiologic-Anatomic-Physiologic) score of ≥3 or a venous clinical severity score for pain of ≥2, or both, and evidence of >50% stenosis on venography, computed tomography venography, magnetic resonance venography, and/or intravascular ultrasound should be considered for venous stenting (level of recommendation Ib) Patients undergoing thrombus removal for acute iliofemoral deep vein thrombosis, in whom a culprit stenotic lesion has been uncovered, should be considered for venous stenting (level of recommendation Ib). Patients with chronic pelvic pain, deep dyspareunia, postcoital pain affecting their quality of life, when other causes have been ruled out, should be considered for venous stenting (level of recommendation Ic). Asymptomatic patients should not be offered venous stenting (level of recommendation IIIc). CONCLUSIONS: Patients with deep VOO have been underdiagnosed and undertreated for decades; however, in recent years, interest from physicians and industry has grown substantially. The advent of simpler and safer treatment options has revolutionized its management, but, unfortunately, formal training for venous disease has not grown at the same rate. Simplifying the technology and training required can result in inconsistent outcomes. These guidelines are aimed at developing standards of care and will serve as an educational platform for future developments.

Avoiding the re-do sternotomy: treatment of an ascending aortic pseudoaneurysm using a percutaneous Amplatzer PFO closure device.

PURPOSE: Ascending aortic pseudoaneurysms are a common phenomenon requiring surgical intervention but can pose high surgical risks in medically complex patients. We report a novel approach to percutaneous closure of ascending aortic pseudoaneurysms using an Amplatzer PFO closure device. CASE REPORT: We present the case of a 65-year-old male with haemoptysis on a background of multiple cardiac surgeries and chronic kidney disease. Serial computerised tomography scans of the thoracic aorta demonstrated an enlarging ascending aortic pseudoaneurysm. Percutaneous closure was considered the safest treatment option. With angiography, the pseudoaneurysm was defined and a 25 mm Amplatzer PFO closure device was deployed. Repeat Computed Tomography aortography performed 43 days later confirmed stable device position and resolution of the pseudoaneurysm. The patient was clinically stable at this follow-up point. CONCLUSION: The off-label use of the Amplatzer PFO device may provide a viable alternative treatment for ascending aortic pseudoaneurysms in medically complex patients to reduce morbidity and mortality.

The utility of hyperspectral imaging in patients with chronic venous disorders.

OBJECTIVE: The underlying pathophysiology of lower limb changes in chronic venous disorders (CVD) may involve alteration in microcirculation and tissue oxygenation. Hyperspectral imaging (HSI) is a noninvasive tool that is used clinically to measure transcutaneous oxygenation in peripheral artery disease and diabetic foot disease. However, there has been little application in venous disease. The aim of this study was to determine if transcutaneous oxygenation in the lower limb, as measured by HSI, changes depending on the clinical component of the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification in CVD. METHODS: This was an observational study of patients with CVD recruited from a vascular specialist clinic at a tertiary hospital from January 2020 to January 2021. Participants were allocated to eight groups according to the clinical component of CEAP classification of CVD. Baseline demographic and risk factor information were collected. Transcutaneous oxygenation was measured using HSI at seven sites around the foot and gaiter area in the supine and standing position. Participants rested supine for 15 minutes before the supine measurements and then stood for 15 minutes before the standing measurements. Tissue oxygenation was analyzed over a fixed circular surface area of 79 mm2 at the target location. Calculations of oxyhemoglobin level (artificial unit [AU]), deoxyhemoglobin level (AU), oxygen saturation (%), and temperature (°C) were obtained. The Northern Ethics Committee (18/NTA/78) approved this conduct of the study and participants signed written consent forms. RESULTS: There were 94 participants (164 lower limbs) included in the study. The median age was 59 years and 59 participants (63%) were women. At all sites except the heel, deoxyhemoglobin measurements increased in the standing position compared with the supine position (P < .001). In the gaiter region, there was nearly a doubling in deoxyhemoglobin level at 5 cm above the medial malleolus (supine 43.88 AU vs standing 80.46 AU; P < .001) and 5 cm above the lateral malleolus (supine 46.33 AU vs standing 87.72 AU; P < .001). When measurements were stratified by clinical class of the CEAP classification, there was a greater increase in deoxyhemoglobin levels with increasing clinical class in the standing position (P < .001). This finding was not observed in the supine measurements. CONCLUSIONS: In CVD, HSI shows an increase in deoxyhemoglobin in the standing compared with supine position, particularly in the gaiter region. Furthermore, standing deoxyhemoglobin increases as the CEAP clinical class increases. Thus, this noninvasive tool may respond to venous physiology and may supplement the clinical class of the CEAP classification system.

Embolic phenomena to the limbs are an independent predictor of in-hospital mortality from infective endocarditis.

BACKGROUND: Infective endocarditis (IE) is a morbid condition with high mortality. We investigated predictors of in-hospital mortality and embolic phenomena in a contemporary Australasian cohort. METHODS: We identified all patients with IE admitted between January 2017 and 30th April 2020 (40 months). Patient characteristics, risk factors and clinical outcomes were retrospectively collected and analysed. RESULTS: One hundred and seventy-two consecutive patients (mean age: 56.8 ± 17.9 years, male: 63%, 114/172) were included. Causative organisms were Staphylococcus aureus (44%, 75/172), Enterococcus faecalis (15%, 26/172), Streptococcus mitis (6%, 10/172) and Staphylococcus epidermidis (3%, 6/172). In-hospital mortality was 15% (25/172). Embolic complications were found among 57% (98/172) of patients, the most common being stroke (23%, 40/172), septic pulmonary emboli (17%, 29/172), splenic and/or renal emboli (17%, 26/172) and peripheral limb emboli (15%, 25/172). Sixty (35%, 60/172) patients underwent cardiac surgery. On multivariable analysis, independent predictors of in-hospital mortality were: increased age (odds ratio: 1.064, per year older, P = 0.001), ICU admission independent of cardiac surgery (OR 9.81, P < 0.001), moderate or severe LV impairment (OR 5.19, P = 0.012) and any sign of embolic phenomena to limbs (OR 5.02, P = 0.006). Multivariable predictors of embolic complications were S. aureus bacteraemia (OR 3.22, P = 0.001) and large vegetation >10 mm (OR 3.04, P = 0.002). CONCLUSION: We demonstrate predictors of in-hospital mortality and embolic phenomena in our cohort. Though age remains a consistent predictor of mortality, surprisingly, signs of embolic phenomena to the limbs was established as an independent predictor of mortality. The mechanism of this is unclear and warrants further evaluation.

Frail patients having vascular surgery during the early COVID-19 pandemic experienced high rates of adverse perioperative events and amputation.

BACKGROUND: Frailty predicts adverse perioperative outcomes and increased mortality in patients having vascular surgery. Frailty assessment is a potential tool to inform resource allocation, and shared decision-making about vascular surgery in the resource constrained COVID-19 pandemic environment. This cohort study describes the prevalence of frailty in patients having vascular surgery and the association between frailty, mortality and perioperative outcomes. METHODS: The COVID-19 Vascular Service in Australia (COVER-AU) prospective cohort study evaluates 30-day and six-month outcomes for consecutive patients having vascular surgery in 11 Australian vascular units, March-July 2020. The primary outcome was mortality, with secondary outcomes procedure-related outcomes and hospital utilization. Frailty was assessed using the nine-point visual Clinical Frailty Score, scores of 5 or more considered frail. RESULTS: Of the 917 patients enrolled, 203 were frail (22.1%). The 30 day and 6 month mortality was 2.0% (n = 20) and 5.9% (n = 35) respectively with no significant difference between frail and non-frail patients (OR 1.68, 95%CI 0.79-3.54). However, frail patients stayed longer in hospital, had more perioperative complications, and were more likely to be readmitted or have a reoperation when compared to non-frail patients. At 6 months, frail patients had twice the odds of major amputation compared to non-frail patients, after adjustment (OR 2.01; 95% CI 1.17-3.78), driven by a high rate of amputation during the period of reduced surgical activity. CONCLUSION: Our findings highlight that older, frail patients, experience potentially preventable adverse outcomes and there is a need for targeted interventions to optimize care, especially in times of healthcare stress.

"More or less": management of type A aortic dissections in the endovascular era.

The management of type A aortic dissection presents a major therapeutic challenge in modern surgical practice. Whilst the traditional dictum, to provide timely surgical intervention with the minimum treatment needed to repair the ascending aorta as well as the primary tear, may be a reasonable strategy in older patients, a tailored approach is desired for younger patients to manage the immediate life-threatening condition, as well as for the management of lifelong complications of the residual dissected aorta. Endovascular technology continues to advance, providing an adjunctive role to open cardiac repair presently to manage downstream aortic pathology, with the aim of striving towards a complete endovascular solution for type A aortic dissections.

A Case of Successful Endovascular Aortic Repair of Primary Aortoenteric Fistula Without Aortic Explantation.

PURPOSE: The objective of this study is to report a case of a primary aortoenteric fistula successfully treated with endovascular repair without aortic explant. CASE REPORT: A 48-year-old man presented with a 24-hour history of hematemesis and malena. A computed tomography (CT) abdomen and pelvis demonstrated a 6 cm infrarenal aortic aneurysm with periaortic stranding and contrast enhancement within the lumen of the third part of the duodenum. The patient underwent emergency Endovascular Aortic Repair (EVAR). The patient was discharged on day 8 of his admission on oral antibiotics. He returned 7 weeks postindex procedure and underwent a laparotomy with omental patch repair of the aortic defect. Intraoperative cultures grew candida albicans, and the patient was discharged on lifelong oral Fluconazole and Amoxycillin-Clavulanic Acid. At 18 months postoperatively, the patient was clinically stable with improved appearances on CT aortogram. CONCLUSION: We discuss the use of EVAR without aortic explant as a possible treatment option in the management of patient with primary aortoenteric fistulae. This may potentially avoid the significant morbidity and mortality associated with aortic explant in suitable candidates without perioperative signs of sepsis.

Safety and feasibility report on nonimplantable endovenous valve formation for the treatment of deep vein reflux.

OBJECTIVE: Definitive treatment techniques for symptomatic deep venous reflux have been relegated to complex and invasive open surgery which is rarely performed today. The BlueLeaf System provides an endovenous method for the formation of deep venous valves without an implant, avoiding the complications associated with permanent foreign materials. The system has the adaptability to form valves within the femoral and popliteal veins at multiple levels in a single procedure. The aim was to determine the midterm safety and efficacy of this novel device in an early feasibility study. METHODS: Feasibility of endovenous deep venous valve formation was assessed in patients with chronic venous insufficiency (Clinical, Etiologic, Anatomic, Pathophysiologic [CEAP] 4-6). Follow-up was completed through 1 year, assessing vein patency and reflux time (RT) with duplex ultrasound examination. Venous clinical improvement was evaluated using the revised Venous Clinical Severity Scale. RESULTS: Of the 14 patients, 13 (93%) had successful formation of at least one monocuspid valve, with a mean number of 1.4 valves (range, 0-3 valves) per patient. There were no device-related serious adverse events during the index procedure. There were no deep venous thromboses reported at any time point, including 10 patients through the 1-year follow-up. In patients with at least one valve formed, site reported duplex ultrasound examination measured the average RT in the popliteal vein below valve formations, was 3.0 ± 1.0 seconds at baseline, 3.9 ± 3.1 seconds at 30 days, and 3.6 ± 2.1 seconds at 360 days. The revised Venous Clinical Severity Scale improved in all 13 successfully treated patients, decreasing from 15.0 ± 6.0 at baseline to 11.6 ± 5.5 at 30 days, 10.7 ± 5.3 at 210 days, and 9.4 ± 5.0 at 360 days (P = .0002; baseline to 360 days). Among the five patients with an ulcer who reached the 360-day follow-up visit, all (100%) healed at least one ulcer. Two patients (40%) healed all ulcers and three patients (60%) had a decrease in ulcers number but remained at C6 at 360 days. The five patients with a total of nine active ulcers at baseline had four active ulcers at 360 days. CONCLUSIONS: The BlueLeaf System holds promise as a minimally invasive means to safely form fully autogenous deep venous valves. Reconstructed deep veins remained patent, without deep venous thrombosis and symptomatic improvement was consistently observed; however, a decrease in the RT was not. Incremental device design improvements have been undertaken to improve valve function. The results of these iterations await further clinical evaluation.

Superficial Femoral Venous Aneurysm in a Patient with Klippel-Trenaunay Syndrome: The Femoral Hernia Mimic.

Venous aneurysms are a rare vascular anomaly characterized by a solitary area of dilatation containing all three layers of the venous vessel wall. Described throughout the venous system, venous aneurysms can be classified as deep or superficial based on the vein involved. Although generally asymptomatic, superficial venous aneurysms can be associated with venous insufficiency or venous thromboembolism and are often confused for soft tissue masses or hernias. In young adults, venous aneurysms are often associated with Klippel-Trenaunay syndrome. In this report, we present a case of a primary superficial venous aneurysm in a patient with Klippel-Trenaunay syndrome mimicking a femoral hernia.

Clinical Evaluation of Portable Wound Volumetric Measurement Devices.

OBJECTIVE: Wound dimensional assessments are important in determining the progress of a wound and the effect of interventions on wound healing. The FastSCAN (FS; Polhemus Inc, Colchester, Vermont) and Silhouette Mobile (SM; ARANZ Medical, Christchurch, New Zealand) are portable devices that quantify surface area, depth, and volume of wounds. This study evaluated their reliability in producing accurate wound measurements. DESIGN AND SETTING: This study was conducted at the Waikato Hospital, Hamilton, New Zealand. PATIENTS AND INTERVENTION: Eleven vascular patients with a combined total of 16 wounds underwent simultaneous wound measurements using three-dimensional computed tomography (CT) reconstruction, FS, and SM. MAIN OUTCOME MEASURE: The validity of FS and SM was tested against CT. Additionally, the interoperator reliability and intraoperator reliability of FS and SM were determined. MAIN RESULTS: The intraoperator reliability and interoperator reliability for volume recordings of the SM were 0.97 and 0.97, respectively, and for the FS were 0.96 and 0.97, respectively. The FS and SM measurements were not significantly different from CT. The SM consistently produced smaller wound volume and depth measurements compared with CT. In contrast, overestimation was observed for FS when compared with CT. However, the volume measurements in one wound were anomalous, being 10 times larger than CT measurements. Excluding this wound, there were strong correlations in wound volumes for SM and CT (r = 0.81; P ≤ .0001), for FS and CT (r = 0.99; P ≤ .001), and for SM and FS (r = 0.99; P ≤ .0001). CONCLUSIONS: Measurements from FS and SM were comparable to CT. Therefore, SM and FS devices both offer the benefit of being noncontact portable devices that produce reproducible and reliable readings.

Measuring Transcutaneous Oxygenation to Validate the Duration Required to Achieve Electrode Equilibration.

OBJECTIVE: The transcutaneous oxygenation measurement (TCOM) system is useful in assessing tissue viability. There are no clear recommendations regarding the duration required for the electrode to equilibrate and reliably evaluate tissue oxygenation values. The objective of this study was to validate the duration required to achieve electrode equilibration in a clinical setting. METHODS: Minute-by-minute recordings using TCOM (TCOM3; Radiometer Medical ApS, Brønshøj, Copenhagen) were obtained for 82 limbs in 50 participants. Twenty-five limbs were in patients with peripheral vascular disease; 30 were in patients with no known peripheral vascular disease; and 27 were in healthy volunteers. Transcutaneous partial pressure of oxygen and carbon dioxide (TcPO2 and TcPCO2) were recorded over a 15-minute period. RESULTS: Participants' TcPO2 decreased and TcPCO2 increased over time. Both changed in a nonlinear fashion, eventually settling at an "equilibrium" where the measurements became stable. The difference in proportional change of TcPO2 between minutes 14 and 15 was 0.8%, and for TcPCO2was 2.9%. Changes in TCOM measurements over time were similar among the 3 groups. CONCLUSIONS: This is the first study to target minute-by-minute variation in TcPO2 and TcPCO2 measurements. Recording for a minimum of 15 minutes allows a reliable period for the TCOM electrode to equilibrate to record absolute values and determine wound healing potential.

Treatment of infrapopliteal post-PTA dissection with tack implants: 12-month results from the TOBA-BTK study.

OBJECTIVES: The Tack implant is designed for focal, minimal metal management of dissections. This study evaluated Tacks for treating postpercutaneous transluminal angioplasty (PTA) dissection in patients with below-the-knee (BTK) arterial occlusive disease. BACKGROUND: PTA is the most commonly used endovascular treatment for patients with occlusive disease of the BTK vessels. Post-PTA dissection is a significant clinical problem that results in poor outcomes, but currently there are limited treatment options for managing dissections. METHODS: This prospective, single-arm study evaluated patients with CLI and BTK lesions; 11.4% were Rutherford category (RC) 4 and 88.6% were RC 5. BTK occlusive disease was treated with standard PTA and post-PTA dissections were treated with Tack placement. The primary safety endpoint was a composite of major adverse limb events (MALE) and perioperative death (POD) at 30 days. Other endpoints included: device success; procedure success (vessel patency in the absence of MALE); freedom from clinically driven target lesion revascularization (CD-TLR); primary patency; and changes in RC. Data through 12 months are presented. RESULTS: Thirty-two of 35 (91.4%) patients had post-PTA dissection and successful deployment of Tacks. Procedural success was achieved in 34/35 (97.1%) patients with no MALEs at 30 days. The 12-month patency rate was 78.4% by vessel, 77.4% by patient, and freedom from CD-TLR was 93.5%. Significant (P < .0001) improvement from baseline was observed in RC (75% of patients improved 4 or 5 steps). CONCLUSION: Tack implant treatment of post-PTA dissection was safe and effective for treatment of BTK dissections and resulted in reasonable 12-month patency and low rates of CD-TLR.

Epidemiology and Outcomes of Abdominal Aortic Aneurysms in New Zealand: A 15-Year Experience at a Regional Hospital.

INTRODUCTION: Abdominal aortic aneurysms (AAA) account for approximately 400 deaths per year in New Zealand (NZ). Waikato Hospital caters to a diverse population comprising a high proportion of the indigenous Maori ethnic group considered to be at higher risk of mortality and morbidity. Despite these population factors, there is no screening program for AAA. The aim of this study was to further define the epidemiology and outcomes of AAA repairs in NZ to investigate the utility of implementing a population-specific screening program. METHODS: A retrospective study of all AAA repairs at Waikato Hospital between July 1996 and November 2010 was performed comparing long-term outcomes between Europeans and Maori considering acuity of presentation, age, gender, and type of repair. Perioperative and overall mortality data were obtained to generate Kaplan-Meier survival curves. RESULTS: 1,036 AAA repairs were performed. Maori presented younger (69.1 vs. 74.5, P < 0.001), had lower male predominance (1.6:1 vs. 3.5:1, P < 0.001), less elective repairs (44% vs. 67%, P < 0.001), and more ruptured AAA (RAAA) (40% vs. 21%, P < 0.001) despite the overall incidence of RAAA decreasing from 26% to 7.8% (P = 0.01). Maori had a lower postoperative 10-year survival compared to Europeans (17.4% vs. 36.5%, P < 0.001). There was an initial survival benefit for endoluminal over open repair but this converged at 4.9 years post repair. CONCLUSIONS: This study highlights the epidemiological trends and survival outcomes of AAA management in Maori and Europeans over 15 years. It provides further evidence supporting the consideration of a population-specific screening program in future.

Hybrid technique for the management of thoracoabdominal aortic thrombosis and symptomatic Trans-Atlantic Inter-Society Consensus "C" aorto-iliac disease.

Objective Thrombotic disease of the thoracic and abdominal aorta co-existing with aorto-iliac disease is a rare clinical association, which poses a great therapeutic challenge and adds to the complexity of the open surgical repair. Method We describe a case of 53-year-old woman with symptomatic thrombus in the thoracic and abdominal aorta down to the aortic bifurcation, which was successfully treated by Thoracic EndoVascular Aortic Repair via the left subclavian artery, open thrombectomy and aorto-iliac bypass. Result Completion angiogram performed through the axillary cannula showed good flow in the aorta, visceral vessels and iliac arteries. Conclusion This hybrid technical approach was a safe and effective strategy to tackle diffuse aortic thrombus with minimal morbidity and visceral embolization. Simultaneous aorto bi iliac bypass with thoracic endovascular aortic repair is a viable approach that can be undertaken with lesser morbidity and mortality risk as compared to complex and highly stressful total open surgical repair.

Perioperative warming, oxygen, and Ilomedin on oxygenation and healing in infrainguinal bypass surgery.

BACKGROUND: Perioperative adjuncts are utilized across surgical specialities with the goal of improving patient outcomes. High-dose oxygen and extended warming are shown to increase wound collagen deposition during abdominal surgery. Prostacyclin is shown to improve limb salvage and patency rate in infrainguinal bypass (IIB) surgery. This study evaluated the impact of these adjuncts on healing and perfusion post IIB surgery. METHODS: This randomized controlled study allocated patients undergoing IIB surgery into three treatment arms (perioperative high-dose oxygen, extended warming, and a synthetic prostacyclin) or a control group. The primary outcome was accumulation of hydroxyproline (OHP, collagen surrogate marker) as collected in polytetrafluoroethylene implants on day 5. Secondary outcomes included levels of growth factors and cytokines, and tissue oxygenation of the wound and foot as measured by hyperspectral technology and ankle-brachial pressure index. Clinical outcomes were observed to day 30, with long-term follow-up of 12 mo. RESULTS: Seventy-one patients completed the study. Comparing treatment groups with the control at day 5, there were no differences in OHP, growth factors or cytokines levels, or improvement in tissue oxygenation at the surgical incision. However, there was more flow to the foot (HT-SUM (%) change) in the Ilomedin group compared to control (0% versus -14.6%, P = 0.045). HT-deoxy was higher at the peripheries in the oxygen and temperature groups, suggesting decreased tissue oxygenation. CONCLUSIONS: The perioperative treatments did not dramatically improve oxygenation or healing of the surgical wound in IIB surgery; however, Ilomedin may result in greater flow to the peripheries.