Gentamicin Containing Collagen Implants and Groin Wound Infections in Vascular Surgery: A Prospective Randomised Controlled Multicentre Trial.

OBJECTIVE: The aim of this study was to assess the effectiveness of gentamicin containing collagen implants in the reduction of surgical site infections (SSIs) in patients undergoing an inguinal incision for vascular surgery. METHODS: Prospective blinded randomised controlled multicentre trial (RCT), performed in four hospitals in The Netherlands and Belgium. This study included 288 patients who underwent an inguinal incision for primary arterial repair (femoral endarterectomy, femorofemoral or femoropopliteal bypass, aortobifemoral bypass, thrombectomy, embolectomy, endovascular aneurysm repair) between October 2012 and December 2015. Patients were randomised to receive a gentamicin implant (study group) or no implant (control group). The calculated sample sizes of 304 patients per group were not reached. Primary outcome was SSI incidence after six weeks. Secondary outcomes were time to onset of infection, length of hospital stay, allergic reactions, treatment with antibiotics, need for re-admission, re-operation and mortality. RESULTS: One hundred fifty-one patients were allocated to the study group (mean age 69 ± 9.2 years) and 137 patients were allocated to the control group (mean age 70 ± 10.4 years). Both groups were homogeneous regarding baseline and intra-operative characteristics. Gentamicin implants did not result in a significant overall reduction of SSIs in the study group (7% vs. 12%, p = .17). In a post hoc analysis comparing two study sites with low (<10%) and two study sites with high (>10%) infection rates in the control group, gentamicin implants significantly reduced SSIs in high risk centres (22% vs. 1%, p < .001), whereas there was no significant effect in low risk centres (13% vs. 7%, p = .30). There were no allergic reactions and all secondary outcomes were comparable between groups. CONCLUSION: Gentamicin implants did not result in a significant overall reduction of SSIs in this RCT. Gentamicin implants did reduce the incidence of SSIs in high risk centres and may be a valuable adjunct to improve outcomes in such vascular centres with a high incidence of wound infections. However, the limitation of not reaching the calculated sample sizes should be considered.

Duplex-guided versus Conventional Percutaneous Transluminal Angioplasty of Iliac TASC II A and B Lesion: A Randomized Controlled Trial.

BACKGROUND: Percutaneous transluminal angioplasty (PTA) requires the use of nephrotoxic contrast. Patients with chronic kidney disease are more prone to develop contrast-induced nephropathy after utilization of contrast. Doppler ultrasound (duplex)-guided PTA (DuPTA) is a novel technique and has recently proven to be a successful alternative to conventional PTA in the treatment of iliac stenotic disease, without the use of contrast. In this randomized controlled trial, we evaluated whether DuPTA is as effective as conventional PTA in the treatment of iliac arterial stenotic disease. METHODS: From June 2013 till January 2017, 142 patients with symptomatic peripheral arterial disease (PAD), with significant (>70%) iliac stenotic lesions (both isolated and patients with multilevel disease without treatment of other lesions), were randomized to receive either conventional PTA or DuPTA of the iliac lesion, regardless of renal function. All patients received an ankle-brachial index, arterial mapping with duplex, and magnetic resonance angiography in the pre-operative work-up. Primary end point was procedural success, defined as passing the guidewire through the stenotic lesion and performing a PTA, with or without stenting. Reduction in peak systolic velocity (PSV) of ≥50% after successful PTA was required in the DuPTA group. Angiographic reduction of more than 50% was required in the interventional group. Decrease in PSV was evaluated in both groups 4 weeks post-procedure. RESULTS: Passing of the guidewire through the stenotic lesion was achieved in 96.5% of the DuPTA group and 98.8% of the PTA group (P = 0.34). Although PSV decreased significantly in both groups 4 weeks post-operative, PSV reduction ≥50% was significantly higher in the DuPTA group, respectively 78% vs. 58% in the PTA group (P < 0.01). The utilization of stents was significantly greater in the DuPTA group (52% vs. 18%, P < 0.01). After correction of potential confounders, significant difference in ≥50% PSV reduction remained; technical success did not differ significantly. CONCLUSIONS: DuPTA is a feasible alternative to conventional PTA in the treatment of PAD on the iliac anatomic level. Duplex examination before removal of the guidewire is recommended to evaluate adequate decrease in PSV and identify potential recoil.

Loss of Kidney Function after Endovascular Treatment of Peripheral Arterial Disease.

BACKGROUND: Administration of radiocontrast during endovascular procedures for peripheral arterial disease (PAD) may cause acute kidney injury, which generally recovers with supportive treatment. Long-term effects of endovascular procedures on renal function remain to be investigated. METHOD: This retrospective observational cohort study includes all patients who newly presented to the vascular surgery outpatient clinic with Rutherford class II or III PAD and who were treated with either supervised exercise therapy or endovascular interventions. Changes in estimated glomerular filtration rates (eGFR) after 1 year were compared between the 2 treatment groups. Multivariate regression analysis and propensity score-matched paired analysis were done to correct for potential confounders. RESULTS: One year after treatment, eGFR was reduced by 8.6 mL/min (95% confidence interval [CI], 7.3-9.9, P < 0.001) after endovascular intervention (n = 284) and by 1.7 mL/min (95% CI, 0.9-25, P < 0.001) after supervised exercise therapy (n = 299). After correction for potential confounders, endovascular interventions were associated with 9.2 mL/min (95% CI, 5.9-12.4, P < 0.001) more renal decline compared to exercise therapy. Similar results were found in the propensity score-matched paired analysis. CONCLUSIONS: Endovascular procedures for PAD are associated with clinically relevant and long-term loss of kidney function.

Loss of kidney function in patients with critical limb ischemia treated endovascularly or surgically.

BACKGROUND: Acute kidney injury after the administration of contrast material during endovascular procedures for peripheral arterial disease generally recovers with supportive treatment. However, long-term effects of endovascular procedures for critical limb ischemia on renal function remain to be investigated. METHODS: This retrospective observational cohort study included all patients who newly presented to the vascular surgery outpatient clinic with Rutherford class 4 to class 6 peripheral arterial disease and who were treated with either endovascular or surgical interventions. Changes in estimated glomerular filtration rate (eGFR) after 1 year were compared between the two types of intervention. Multivariate linear regression analysis was done to correct for potential confounders. RESULTS: One year after treatment, eGFR was reduced by 15.0 mL/min (95% confidence interval [CI], 13.1-17.0; P < .001) after endovascular interventions (n = 209) and by 7.6 mL/min (95% CI, 5.1-10.0; P < .001) after surgical therapy (n = 81). Although eGFR rates decreased in both groups, loss of renal function was significantly greater in patients after endovascular interventions (P < .001). Furthermore, 77% of patients receiving endovascular interventions experienced fast renal decline (defined as >4 mL/min loss of eGFR within 1 year) compared with 54% of patients treated surgically (P < .001). After correction for potential confounders, endovascular intervention was associated with 7.4 mL/min (95% CI, 5.4-9.3; P < .001) greater loss of renal function compared with patients treated surgically. CONCLUSIONS: Endovascular procedures for critical limb ischemia are associated with clinically relevant permanent long-term loss of kidney function. This loss of renal function is greater than in comparable patients who were treated with open surgery.

Radiation Exposure during Percutaneous Transluminal Angioplasty for Symptomatic Peripheral Arterial Disease.

BACKGROUND: Endovascular interventions often are the preferred treatment in peripheral arterial disease for both intermittent claudication and chronic critical limb ischemia. Ever more advanced and anatomically complex procedures are being performed, which may increase the radiation exposure of patients and medical staff. We sought to determine the radiation exposure sustained in contemporary interventional radiology practice. METHODS: A single-center observational cohort study of patients undergoing endovascular interventions for symptomatic peripheral arterial disease between January 1st, 2011 and July 31st, 2013 was performed. Radiation dose area product (DAP), peak skin dose (PSD), fluoroscopy time, and volume of contrast media were either measured or calculated and stratified according to patient demographics and anatomic location. RESULTS: In 951 patients, who were treated with endovascular interventions, mean DAP was 108 ± 88 Gy × cm(2) and mean fluoroscopy time was 13 ± 12 min. DAP was significantly higher for aortoiliac procedures (142 ± 103 Gy × cm(2)) compared with femoral (58 ± 73 Gy × cm(2)), below-knee (45 ± 51 Gy × cm(2)) and multilevel (83 ± 90 Gy × cm(2)) procedures (P < 0.001 for all comparisons). PSD was significantly higher for aortoiliac procedures (0.99 ± 0.54 Gy) compared with femoral (0.55 ± 0.55 Gy), below-knee (0.48 ± 0.27 Gy), and multilevel (0.68 ± 0.47 Gy) procedures (P < 0.001 for all comparisons). In contrast, mean fluoroscopy time in aortoiliac interventions was significantly shorter (10 ± 15 min) compared with femoral (15 ± 12 min), below-knee (19 ± 10 min), and multilevel (23 ± 14 min) procedures (P < 0.001 for all comparisons). CONCLUSIONS: Endovascular interventions in patients with symptomatic peripheral arterial disease involve a substantial radiation dose. Although fluoroscopy time is shorter, aortoiliac interventions result in greater radiation exposure than femoropopliteal or infrapopliteal interventions.

Prevention of postcontrast acute kidney injury after percutaneous transluminal angioplasty by inducing RenalGuard controlled furosemide forced diuresis with matched hydration: study protocol for a randomised controlled trial.

INTRODUCTION: Percutaneous transluminal angioplasty (PTA) is often complicated due to postcontrast acute kidney injury (PC-AKI) in patients diagnosed with chronic kidney disease (CKD). Hydration therapy is the cornerstone in the prevention of PC-AKI. Furosemide forced diuresis with matched hydration using the RenalGuard system enables a steady balance between diuresis and hydration. A randomised controlled trial will be performed in order to investigate whether furosemide forced diuresis with matched hydration in combination with the RenalGuard system decreases incidence of PC-AKI in patients with CKD receiving a PTA of the lower extremities. Furthermore, we will investigate whether sampling of urine biomarkers 4 hours after intervention can detect PC-AKI in an earlier stage compared with the golden standard, serum creatinine 48-72 hours postintervention. METHODS AND ANALYSIS: A single-centre randomised controlled trial will be conducted. Patients >18 years in need of a PTA of the lower extremities and diagnosed with CKD will be randomly assigned to receive either standard of care prehydration and posthydration or furosemide forced diuresis with matched hydration periprocedural using the RenalGuard system. Four hours postintervention, a urine sample will be collected of all participating patients. Serum creatinine will be sampled within 10 days prior to intervention as well as 1, 3 and 30 days postintervention. The primary endpoint is incidence of PC-AKI post-PTA. Secondary endpoint is the rise of urine biomarkers 4 hours postintervention. ETHICS AND DISSEMINATION: Study protocol is approved by the research ethics committee and institutional review board (reference number 16 T-201 and NL59809.096.16). Study results will be disseminated by oral presentation at conferences and will be submitted to a peer-reviewed journal. It is anticipated that study results will offer a solution to contrast-induced nephropathy in patients with CKD receiving a PTA of the lower extremities. TRIAL REGISTRATION NUMBER: NTR6236; Pre-results. EUDRACT NUMBER: 2016-005072-10.