Hyperbaric oxygen therapy for nonhealing wounds: Treatment results of a single center.

The present article evaluates the results of the treatment with adjuvant hyperbaric oxygen therapy (HBOT) of patients with nonhealing, chronic wounds. In the period 2013 to 2016, 248 patients were referred from various hospitals because of chronic wounds that were recalcitrant in healing despite standard wound care as described in national and international guidelines. After inclusion, all patients were treated with HBOT and subjected to a weekly standard wound care treatment. During each HBOT session, 100% O2 was administered for 75 minutes under increased pressure of 2.4 ATA. Wounds and quality of life were assessed before and after the total treatment period. A total of 248 patients have been evaluated. Diabetic foot ulcers were present in 134 patients, the remainder (114 patients) showed a variety of wound locations and etiologies. The number of HBOT treatments amounted to an average of 48 (range 20-68) sessions. Before referral to our clinic, 31% of all wounds had existed for at least 18 months (72 patients). After HBOT, 81% of all wounds were near complete healing or completely healed, in 13% of the cases the wound was stable, and in 2% minor or major amputation had to be carried out. The mean treatment time for wounds pre-existing fewer than 6 weeks ("early referrals") was 67 days, and 119 days for wounds pre-existing more than 18 months ("late referrals"). A majority of the patients in our study referred with nonhealing wounds clinically improved when adjuvant HBOT was added to standard wound care protocols. No differences in success rate were seen between diabetic and nondiabetic wounds. It showed that HBOT is a well-tolerated treatment.

Severe Infrarenal Atheroma Load in Open Aortic Aneurysm Repair Is Not a Risk Factor for Postoperative Acute Kidney Injury.

BACKGROUND: Acute kidney injury (AKI) after open aortic repair is subject to multiple patient- and operation-related variables. Hostile neck morphology in open aneurysm repair is thought to contribute to this AKI risk postoperatively. The aim of this study was to evaluate if large neck atheroma is a possible risk factor in the postoperative development of AKI. METHODS: Retrospectively 137 patients were evaluated for neck atheroma and AKI incidence. Atheroma load measurements were performed by 2 different techniques. Results were compared, and secondly a univariate analysis was performed for multiple additional risk factors regarding AKI occurrence. RESULTS: Significant (>30%) neck atheroma was not associated with a higher risk for developing AKI (odds ratio [OR]: 1.81; 95% confidence intervals: 0.74-4.44). Overall incidence of AKI based upon Acute Kidney Injury Network criteria was 19.7%. In univariate analysis coronary artery disease and the presence of a renal artery stenosis were both significantly associated with AKI (OR: 2.38, 3.31, respectively) as well as the use of B-blockers and angiotensin converting enzyme inhibitors (OR 3.05, 2.48, respectively). CONCLUSIONS: Cross-clamping in case of significant neck atheroma during open aortic aneurysm repair is not associated with increased risk of AKI. Defining high-risk patients based on additional risk factors must be a part of preoperative patient selection.

Determinants of Acute Kidney Injury and Renal Function Decline After Endovascular Abdominal Aortic Aneurysm Repair.

OBJECTIVE/BACKGROUND: Endovascular aneurysm repair (EVAR) may be associated with renal injury and more insight is needed into potential risk factors. The aim was to identify clinical, anatomical, and peri-procedural parameters as potential risk factors for the occurrence of acute kidney injury (AKI) and to evaluate chronic kidney disease (CKD) after EVAR. METHODS: A cohort of 212 consecutive patients who underwent elective EVAR for abdominal aortic aneurysm from January 2009 to October 2016 was included. A subgroup of 149 patients with 2 years follow-up was compared with a set of 135 non-operated aneurysm patients with smaller aneurysms (similar cardiovascular risk profile) to assess CKD. Primary outcomes were AKI (Acute Kidney Injury Network criteria) and CKD measured by estimated glomerular filtration rate (Kidney Disease Improving Global Outcomes guidelines). For AKI, candidate risk factors were identified by univariate and multivariate logistic regression analysis; for chronic renal function decline, risk factors were identified using Cox regression analysis. RESULTS: AKI occurred in 30 patients (15%). On multivariate analysis, the use of angiotensin II blocker (odds ratio [OR] 4.08, 95% confidence interval [CI] 1.38-12.07) and peri-operative complications (OR 3.12, 95% CI 1.20-8.10) were independent risk factors for AKI, whereas statin use was a protective factor (OR 0.19, 95% CI 0.07-0.52). EVAR resulted in a significant increase (23.5%) in the occurrence of CKD compared with the control group (6.7%; p <.001). On univariate and multivariate Cox regression the risk factors: aortic neck diameter (per mm increase) (hazard ratio [HR] 1.13, 95% CI 1.02-1.25), renal artery stenosis >50% (HR 2.24, 95% CI 1.05-4.79), and the occurrence of AKI (HR 2.19, 95% CI 0.99-4.85) were significant predictors of CKD. CONCLUSION: This study identified use of angiotensin II blockers and peri-operative complications as risk factors for AKI. In addition, the problem of renal function decline after EVAR is highlighted, which indicates that prolonged protective measures (e.g., in those patients at high risk) over time are needed to improve patient outcomes.

Long-Term Follow-up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia.

BACKGROUND: Clinical outcomes reported after treatment of infrapopliteal lesions with drug-eluting stents (DESs) have been more favorable compared with percutaneous transluminal angioplasty with a bailout bare metal stent (PTA-BMS) through midterm follow-up in patients with critical limb ischemia. In the present study, long-term results of treatment of infrapopliteal lesions with DESs are presented. METHODS AND RESULTS: Adults with critical limb ischemia (Rutherford category ≥4) and infrapopliteal lesions were randomized to receive PTA-BMS or DESs with paclitaxel. Long-term follow-up consisted of annual assessments up to 5 years after treatment or until a clinical end point was reached. Clinical end points were major amputation (above ankle level), infrapopliteal surgical or endovascular reintervention, and death. Preserved primary patency (≤50% restenosis) of treated lesions was an additional morphological end point, assessed by duplex sonography. In total, 74 limbs (73 patients) were treated with DESs and 66 limbs (64 patients) were treated with PTA-BMS. The estimated 5-year major amputation rate was lower in the DES arm (19.3% versus 34.0% for PTA-BMS; P=0.091). The 5-year rates of amputation- and event-free survival (survival free from major amputation or reintervention) were significantly higher in the DES arm compared with PTA-BMS (31.8% versus 20.4%, P=0.043; and 26.2% versus 15.3%, P=0.041, respectively). Survival rates were comparable. The limited available morphological results showed higher preserved patency rates after DESs than after PTA-BMS at 1, 3, and 4 years of follow-up. CONCLUSIONS: Both clinical and morphological long-term results after treatment of infrapopliteal lesions in patients with critical limb ischemia are improved with DES compared with PTA-BMS. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00471289.

Percutaneous Transluminal Angioplasty and Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI) Trial.

BACKGROUND: Endovascular infrapopliteal treatment of patients with critical limb ischemia using percutaneous transluminal angioplasty (PTA) and bail-out bare metal stenting (BMS) is hampered by restenosis. In interventional cardiology, drug-eluting stents (DES) have shown better patency rates and are standard practice nowadays. An investigator-initiated, multicenter, randomized trial was conducted to assess whether DES also improve patency and clinical outcome of infrapopliteal lesions. METHODS AND RESULTS: Adults with critical limb ischemia (Rutherford category ≥4) and infrapopliteal lesions were randomized to receive PTA±BMS or DES with paclitaxel. Primary end point was 6-month primary binary patency of treated lesions, defined as ≤50% stenosis on computed tomographic angiography. Stenosis >50%, retreatment, major amputation, and critical limb ischemia-related death were regarded as treatment failure. Severity of failure was assessed with an ordinal score, ranging from vessel stenosis through occlusion to the clinical failures. Seventy-four limbs (73 patients) were treated with DES and 66 limbs (64 patients) received PTA±BMS. Six-month patency rates were 48.0% for DES and 35.1% for PTA±BMS (P=0.096) in the modified-intention-to-treat and 51.9% and 35.1% (P=0.037) in the per-protocol analysis. The ordinal score showed significantly worse treatment failure for PTA±BMS versus DES (P=0.041). The observed major amputation rate remained lower in the DES group until 2 years post-treatment, with a trend toward significance (P=0.066). Less minor amputations occurred after DES until 6 months post-treatment (P=0.03). CONCLUSIONS: In patients with critical limb ischemia caused by infrapopliteal lesions, DES provide better 6-month patency rates and less amputations after 6 and 12 months compared with PTA±BMS. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00471289.

Transpopliteal stenting of femoral occlusions in patients with critical limb ischemia using a 4-French system.

PURPOSE: In many patients with critical limb ischemia (CLI), transfemoral endovascular recanalization is the preferred treatment. Transpopliteal treatment may be used in patients with inaccessible groins. This retrospective study regards transpopliteal stenting of superficial femoral artery (SFA) occlusions using a 4F system. MATERIALS AND METHODS: Eleven patients (4 male and 7 female [mean age 77 years]) underwent 12 attempts of transpopliteal recanalization of long SFA occlusions (Trans-Atlantic InterSociety Consensus B through D). All patients had CLI (Rutherford 4 to 6) and were nonoperable due to poor general condition. Indications for transpopliteal access were proximal/flush SFA occlusions (n = 5), failure of antegrade recanalization (n = 4), infected femoral-femoral crossover bypass (n = 2), and occlusion of both the native SFA and the femoral-popliteal bypass (n = 1). The popliteal artery was punctured under ultrasound guidance. Occlusions were recanalized subintimally, and 4F compatible stents were implanted. RESULTS: Technical success rate (<30 % residual stenosis) was achieved in 83 % of cases. In two patients, stent dislocation occurred while the sheath was removed. One arteriovenous fistula was successfully treated with additional stenting. During 6-month follow-up, there were no major amputations, and three patients died from nonrelated causes. Fifty percent of patients alive after 6 months improved to Rutherford score ≤3. The duplex restenosis (>50 %) rate at 6 months was 50 %. CONCLUSION: Transpopliteal primary stenting of complex SFA lesions in CLI for a temporary bypass is now technically feasible using a 4F system. Technical results are promising. Clinical results after 6 months are acceptable when taking into consideration that this approach may be the last option for limb salvage.

Update on PADI trial: percutaneous transluminal angioplasty and drug-eluting stents for infrapopliteal lesions in critical limb ischemia.

The Percutaneous transluminal Angioplasty and Drug eluting stents for Infrapopliteal lesions in critical limb ischemia (PADI) trial is a prospective, multicenter, randomized, controlled, double-arm study investigating the safety and efficacy of primary paclitaxel-eluting stent implantation vs primary percutaneous transluminal angioplasty (PTA) in infrapopliteal lesions in critical limb ischemia (CLI). PTA with provisional "bailout" stent implantation is currently an accepted treatment for arterial obstructions in CLI, including those in below-the-knee arteries. A drawback compared to open bypass surgery is the relatively high restenosis rate. One proposed method to reduce restenosis is the use of drug-eluting stents (DES), as these have shown good results in the coronary bed. Primary DES implantation for focal obstructions in infrapopliteal arteries in CLI potentially reduces restenosis compared to PTA alone and may subsequently prolong effect of treatment, allowing for better wound healing, and preventing recurrence of symptoms. In this article, we report on rationale, design, and progress of the PADI trial, which investigates the safety and efficacy of a paclitaxel-eluting stent system compared to PTA with provisional bare metal stent implantation.

Treatment for peripheral arterial obstructive disease: An appraisal of the economic outcome of complications.

OBJECTIVE: This study determined the average estimated total costs after treatment for peripheral arterial occlusive disease (PAOD) and evaluated the effect of postoperative complications and their consequences for the total costs. METHODS: Cost data on all admissions involving treatment for PAOD from January 2007 until July 2007 were collected. A prospective analysis was made using the patient-related risk factor and comorbidity (Society for Vascular Surgery/International Society of Cardiovascular Surgeons) classification, primary and secondary treatment, and prospectively registered complications. At admission, patients without complications were placed in group A, and those with complications were in group B. Prospectively registered complications were divided into patient management (I), surgical technique (II), patient's disease (III), and outside surgical department (IV). The consequences of these were divided into minor complication, no long-term consequence (1A), additional medication or transfusion (1B), surgical reoperation (2A), prolonged hospital stay (2B), irreversible physical damage (3), and death (4). The main outcome measures were total costs of patients and costs per patient (PP), with or without the presence of complications, cost of complications and costs per complication (PC), and the costs of their consequences calculated in euros (euro). RESULTS: Ninety patients (mean age, 71.4 years; 59% men) were included. Group B patients had a significantly higher American Society of Anesthesiologists (4) and Fontaine (3) classification and more secondary procedures. Total costs were euro 1,716,852: group A, euro 512,811 (PP euro 12,820); and group B, euro 1,204,042 (PP euro 24,081). The costs of the 115 complications were euro 568,500 (PC euro 4943). Split by the cause of the complication, costs were I, euro 95,924 (PC euro 2998); II, euro 163,137 (PC euro 8157); III, euro 289,578 (PC euro 5171); and IV, euro 19,861 (PC euro 2837). The increase of costs in group B was mainly caused by additional medication or transfusion (1B) euro 348,293 (61.3%), a surgical reoperation (2A) euro 118,054 (20.8%), or prolonged hospital stay (2B) euro 60,451 (10.6%). Patients who died caused 23% of the total costs. CONCLUSION: Complications cause an increase of the average estimated total costs in the treatment for peripheral arterial occlusive disease and are responsible for 33% of these total costs. The most expensive complications were errors in surgical technique and patient's disease, resulting in surgical reoperation or additional medication, or both, or transfusion, the two most expensive consequences.

Ruptured internal iliac artery aneurysm: staged emergency endovascular treatment in the interventional radiology suite.

Ruptured aneurysms of the internal iliac artery (IIA) are rare and challenging to treat surgically. Due to their anatomic location they are difficult to operate on and perioperative morbidity is high. An endovascular approach can be helpful. We recently treated a patient with a ruptured IIA aneurysm in the interventional radiology suite with embolization of the side-branch of the IIA and placement of a covered stent in the ipsilateral common and external iliac arteries. A suitable stent-graft was not available initially and had to be brought in from elsewhere. An angioplasty balloon was temporarily placed across the ostium of the IIA to obtain hemostasis. Two hours later, the procedure was finished by placing the stent-graft.

Endovascular aneurysm repair with a bifurcated endovascular graft at a primary referral center: influence of experience, age, gender, and aneurysm size on suitability.

OBJECTIVE: The purpose of this study was to assess the suitability for endovascular repair of abdominal aortic aneurysm (EVAR) in an unselected patient population. PATIENTS AND METHODS: Between February 1999 and May 2002 all consecutive patients with a nonemergent abdominal aortic aneurysm (AAA) were prospectively examined with contrast material-enhanced spiral computed tomography (CT). Those patients probably suitable for EVAR on the basis of CT findings underwent calibrated angiography. A panel of radiologists and vascular surgeons reviewed the clinical data and vascular anatomy, and decided on the appropriateness of EVAR with the bifurcated Zenith AAA endovascular graft. RESULTS: One hundred seven patients were included. Fifty-six patients (52%) had one or more contraindications for EVAR. Unsuitability was most frequently (88%) related to the proximal neck. Inadequate neck length was the most common specific reason. Inadequate iliac anatomy was the reason for unsuitability in 59% of patients. The rate of unsuitability decreased from 61% during the first half of the study to 40% during the second half (P =.03) Unsuitability was equal between men and women. Age and maximum diameter did not differ between candidates and noncandidates. CONCLUSION: Almost half (48%) of patients with an infrarenal AAA referred to a primary referral center are suitable for EVAR with the bifurcated Zenith AAA endovascular graft. Neck anatomy was the most frequent reason for rejection. Rate of suitability increased over time, probably as a result of increasing experience. Suitability was not influenced by gender, age, or aneurysm size.