Jean-Baptiste Ricco

Early and late outcomes of percutaneous treatment of TransAtlantic Inter-Society Consensus class C and D aorto-iliac lesions

OBJECTIVES The aim of this study was to analyze the technical success and long-term patency of the endovascular treatment of TransAtlantic Inter-Society Consensus (TASC) C and D aorto-iliac arterial lesions. METHODS All studies reporting original series of patients published in English between 2000 and 2010 were enrolled into meta-analysis. Separate meta-analyses were performed for groups with immediate technical success, 12-month patency, and long-term outcomes. Subgroup analyses were performed to determine if there were differences in outcomes between patients with varying types of lesions (TASC C or D lesions) or between different stenting strategies, including primary or selective stenting. RESULTS Sixteen articles consisting of 958 patients were enrolled in this meta-analysis. The pooled estimate for technical success was 92.8% (95% confidence interval [CI], 89.8%-95.0%, 749 cases). Primary patency at 12 months was 88.7% (95% CI, 85.9%-91.0%, 787 cases). Subgroup analyses demonstrated a technical success rate of 93.7% (95% CI, 88.9%-96.5%) and a 12-month primary patency rate of 89.6% (95% CI, 84.8%-93.0%) for TASC C lesions. For TASC D lesions, these rates were 90.1% (95% CI, 76.6%-96.2%) and 87.3% (95% CI, 82.5%-90.9%), respectively. The technical success and 12-month primary patency rates for primary stenting were 94.2% (95% CI, 91.8%-95.9%) and 92.1% (95% CI, 89.0%-94.3%), respectively; for selective stenting, these rates were 88.0% (95% CI, 67.9%-96.2%) and 82.9% (95% CI, 72.2%-90.0%), respectively. The long-term, primary patency rates for patients receiving primary stenting were significantly better than those receiving selective stenting. Publication bias was not significant for these analyses. CONCLUSIONS This study demonstrates that early and midterm outcomes of endovascular treatment for TASC C and D aorto-iliac lesions were acceptable, with a better patency for primary stenting than selective stenting.

Why Calls for More Routine Carotid Stenting Are Currently Inappropriate: An International, Multispecialty, Expert Review and Position Statement

Why Calls for More Routine Carotid Stenting Are Currently Inappropriate An International, Multispecialty, Expert Review and Position Statement

Short-term results of a randomized trial examining timing of carotid endarterectomy in patients with severe asymptomatic unilateral carotid stenosis undergoing coronary artery bypass grafting

OBJECTIVE This study evaluated the timing of carotid endarterectomy (CEA) in the prevention of stroke in patients with asymptomatic carotid stenosis >70% receiving a coronary artery bypass graft (CABG). METHODS From January 2004 to December 2009, 185 patients with unilateral asymptomatic carotid artery stenosis >70%, candidates for CABG, were randomized into two groups. In group A, 94 patients received a CABG with previous or simultaneous CEA. In group B, 91 patients underwent CABG, followed by CEA. All patients underwent preoperative helical computed tomography scans, excluding significant atheroma of the ascending aorta or aortic arch. Baseline characteristics of the patients, type of coronary artery lesion, and preoperative myocardial function were comparable in the two groups. In group A, all patients underwent CEA under general anesthesia with the systematic use of a carotid shunt, and 79 patients had a combined procedure and 15 underwent CEA a few days before CABG. In group B, all patients underwent CEA, 1 to 3 months after CABG, also under general anesthesia and with systematic carotid shunting. RESULTS Two patients (one in each group) died of cardiac failure in the postoperative period. Operative mortality was 1.0% in group A and 1.1% in group B (P = .98). No strokes occurred in group A vs seven ipsilateral ischemic strokes in group B, including three immediate postoperative strokes and four late strokes, at 39, 50, 58, and 66 days, after CABG. These late strokes occurred in patients for whom CEA was further delayed due to an incomplete sternal wound healing or because of completion of a cardiac rehabilitation program. The 90-day stroke and death rate was 1.0% (one of 94) in group A and 8.8% (eight of 91) in group B (odds ratio [OR], 0.11; 95% confidence interval [CI], 0.01-0.91; P = .02). Logistic regression analysis showed that only delayed CEA (OR, 14.2; 95% CI, 1.32-152.0; P = .03) and duration of cardiopulmonary bypass (OR, 1.06; 95% CI, 1.02-1.11; P = .004) reliably predicted stroke or death at 90 days. CONCLUSIONS This study suggests that previous or simultaneous CEA in patients with unilateral severe asymptomatic carotid stenosis undergoing CABG could prevent stroke better than delayed CEA, without increasing the overall surgical risk.

Unilateral Iliac Artery Occlusive Disease: A Randomized Multicenter Trial Examining Direct Revascularization Versus Crossover Bypass

This randomized trial compared the patency of direct unilateral aorto- or iliofemoral prosthetic bypass with that of crossover femorofemoral or iliofemoral bypass in unilateral atheromatous occlusive disease of the iliac artery. Between May 1986 and March 1991, 143 patients were enrolled in this study (74 crossover and 69 direct revascularizations). Cardiovascular risk factors, preoperative symptoms, and atheromatous lesions were similar in both groups. Patients were followed by Duplex scanning with systolic pressure index measurements. Routine digital subtraction arteriograms were obtained postoperatively and separately, when hemodynamic anomalies developed. Mean follow-up was 22 months. One patient with direct revascularization died postoperatively. Primary patency of direct revascularizations was 89.8% at 48 months compared with 52% for crossover bypass. This difference was statistically significant. Secondary patency of direct and crossover revascularization at 48 months was 92.9% and 93.6%, respectively (not significant). Even though crossover bypasses seem attractive because of their technical simplicity and low morbidity, our results suggest that direct revascularizations are preferable in the young patient with no major operative risks, while crossover bypasses remain indicated in patients at risk.

Laparoscopic aortic surgery: Techniques and results

OBJECTIVE This review describes and evaluates the results of laparoscopic aortic surgery. METHODS We describe the different laparoscopic techniques used to treat aortic disease, including (1) total laparoscopic aortic surgery (TLS), (2) laparoscopy-assisted procedures including hand-assisted laparoscopic surgery (HALS), and (3) robot-assisted laparoscopic surgery, with their current indications. Results of these techniques are analyzed in a systematic review of the clinical series published between 1998 and 2008, each containing >10 patients with complete information concerning operative time, clamping time, conversion rate, length of hospital stay, morbidity, and mortality. RESULTS We selected and reviewed 29 studies that included 1073 patients. Heterogeneity of the studies and selection of the patients made comparison with current open or endovascular surgery difficult. Median operative time varied widely in TLS, from 240 to 391 minutes. HALS had the shortest operating time. Median clamping time varied from 60 to 146 minutes in TLS and was shorter in HALS. Median hospital stay varied from 4 to 10 days regardless of the laparoscopic technique. The postoperative mortality rate was 2.1% (95% confidence interval, 1.4-3.0), with no significant difference between patients treated for occlusive disease or for aneurysmal disease. Conversion to open surgery was necessary in 8.1% of patients and was slightly higher with TLS than with laparoscopy-assisted techniques (P = .07). CONCLUSIONS Analysis of these series shows that laparoscopic aortic surgery can be performed safely provided that patient selection is adjusted to the surgeons experience and conversion is liberally performed. The future of this technique in comparison with endovascular surgery is still unknown, and it is now time for multicenter randomized trials to demonstrate the potential benefit of this type of surgery.

The LGM Vena-Tech Caval Filter: Results of a Multicenter Study

Caval filters have proved essential to the progress being made in the prevention of recurrent pulmonary embolism. A prospective multicenter study was conducted to evaluate the efficacy and possible complications relating to the LGM Vena-Tech percutaneous caval filter, which has been used in Europe since 1989. A total of 222 patients who had undergone LGM Vena-Tech filter placement between September 1989 and December 1991 were included in this study. Two hundred twenty caval filters were positioned via the percutaneous route: 154 of them via the jugular or subclavian vein and 66 via the femoral vein. Two filters could not be implanted. The in-hospital mortality rate was 1.7% (four patients), which included one patient who died of intraoperative recurrent pulmonary embolism. Mean follow-up was 15 months. Forty-one patients died during follow-up (actuarial survival 65.4% +/- 6% at 30 months). There were five cases of recurrent pulmonary embolism (cumulative freedom from pulmonary embolism 93.2% +/- 3.8% at 30 months). Ten patients had thrombosis of the inferior vena cava (actuarial caval patency 94% +/- 3.6% at 30 months). Eight filters (3.6%) migrated over distances that were less than the height of one vertebra. Shifting did not lead to any cases of thrombosis or recurrent pulmonary embolism. Ten filters tilted between 15 and 25 degrees in relation to the inferior vena cava axis. Recurrent pulmonary embolism never occurred concurrently with filter tilting. The LGM Vena-Tech caval filter ensures satisfactory prevention of pulmonary embolism with a low rate of complications. However, because its long-term fate is not known, its use should be restricted to cases in which heparin treatment has failed or is contraindicated.

Carotid bypass with polytetrafluoroethylene grafts: a study of 110 consecutive patients

BACKGROUND Carotid endarterectomy (CEA) is the standard treatment for atherosclerotic lesions involving the carotid bifurcation. However, CEA can be challenging under some conditions. We describe the technique and outcome of prosthetic carotid bypass grafting (PCB) with polytetrafluoroethylene (PTFE) grafts as an elective alternative to CEA. PATIENTS AND METHODS This retrospective analysis of prospectively collected data came from a series of 110 consecutive PCBs, that is, 9.6% of 1140 carotid revascularization procedures performed in our department between September 1986 and July 2002. Primary indications for PCB were extensive atherosclerotic lesions (n = 45, 40.9%), carotid stenosis associated with kinking (n = 29, 26.4%), recurrent stenosis (n = 18, 16.4%), and stenosis after radiation therapy (n = 7, 6.4%). RESULTS The combined stroke and death rate at 30 days was 0.9%. Mean duration of follow-up was 647 +/- 71 days. Four carotid bypass grafts (3.6%) became occluded, and stenosis recurred in 1 (0.9%). At 3 years, overall actuarial survival was 81.4 +/- 11.5 and actuarial stroke-free rate was 97.7 +/- 2.3. There were no fatal strokes. CONCLUSION PCB is a viable technique for treatment of extensive atherosclerotic carotid lesions, recurrent carotid stenosis, and carotid stenosis after radiation therapy. Postoperative stroke, occlusion, and recurrent stenosis rates are comparable to those associated with CEA performed under optimal conditions.

Use of abdominal aortic endovascular prostheses in France from 1999 to 2001

BACKGROUND Since the introduction of endovascular repair (EVR) for infrarenal abdominal aortic aneurysm (AAA), clinical evaluation has been under way in many countries throughout the world. The main purpose of this retrospective study was to determine outcome of EVR with aortic endovascular prostheses (AEPs) and to evaluate the extent to which French practitioners have complied with regulatory and clinical guidelines for the use of these trial devices. METHODS This retrospective study was conducted by the French National Health Insurance Fund for Salaried Workers. Data were compiled on EVR procedures performed at health care institutions all over mainland France between June 1999 and May 2001. RESULTS A total of 1012 AEPs were deployed for AAA repair in France during the study period. Only 151 (14.9%) of these EVR procedures were carried out within an approved investigational setting with informed patient consent. Only 149 of the 861 patients (17.3%, 95% confidence interval [CI], 14.9 to 19.9%) who underwent endovascular repair in noninvestigational settings signed informed consent forms. In 452 cases (46.5%), the diameter of the AAA was 50 mm or less. Complete outcome data for the first year were available for 891 patients (88%). Complications occurred in 177 of these patients (19.9%, 95% CI, 17.3 to 22.6%). There were a total of 47 deaths (5.3%, 95% CI, 3.9 to 6.9%), including 27 during the first 30 postoperative days. Other major events during the first year after AEP implantation were ruptured AAA in 5 patients, conversion to open operation in 15, and additional endovascular treatment in 52. Data on clinical surveillance were available for 987 patients (97.5%) with a mean follow-up of 345 days. Only 294 patients (29.8%, 95% CI, 27.0 to 32.7%) underwent complete imaging within the first month after AEP implantation. A total of 184 patients (18.6%, 95% CI, 16.3 to 21.2%) received no surveillance at all. CONCLUSION This study shows the need for improvement in the clinical evaluation of new devices and medical technologies in France. Study findings also confirm the significant incidence of adverse outcomes and necessity for routine surveillance after EVR of AAA with AEP. However, risk/benefit analysis is difficult because most procedures were not carried out within a proper investigational context.

In vitro evaluation of the antimicrobial efficacy of a new silver-triclosan vs a silver collagen-coated polyester vascular graft against methicillin-resistant Staphylococcus aureus

OBJECTIVES Vascular graft infection is a rare but serious complication of vascular reconstructive surgery. This in vitro study investigated the antimicrobial efficacy of a new, silver-triclosan collagen-coated polyester vascular graft compared with a silver collagen-coated polyester vascular graft alone during the first 24 hours. METHODS The antimicrobial efficacy of the investigated vascular grafts was assessed by performing a time-kill kinetic assay following Clinical and Laboratory Institute Standards-approved guidelines M26-A. For the purpose of the experimental study, the ATCC 33591 strain of methicillin-resistant Staphylococcus aureus (American Type Culture Collection, Manassas, Va) was used. All assays were repeated sixfold. Bacterial survival numbers were obtained at 1, 4, 8, 12, and 24 hours using a standard plate count procedure. Bactericidal activity was defined as a 3 log(10) reduction factor (logRF), according to the approved guideline M26-A. RESULTS Both antimicrobial vascular grafts achieved >3 logRF and fulfilled the efficacy criterion for bactericidal activity but performed differently in their speed of antimicrobial action. The silver-triclosan vascular graft achieved 3.37 logRF after 8 hours, and the silver vascular graft showed a 4.19 logRF after 24 hours. The silver-triclosan graft yielded significantly lower colony-forming units/mL counts after 4 hours compared with the silver graft (4.29 × 10(4) vs 1.03 × 10(6); P = .031). CONCLUSIONS Both antimicrobial collagen-coated polymer vascular grafts showed bactericidal activity against methicillin-resistant Staphylococcus aureus in vitro. Although the silver-triclosan vascular graft showed a faster antimicrobial efficacy, the silver graft exhibited its antimicrobial properties after 24 hours. Which concept will protect an implanted vascular prosthetic graft better from bacterial contamination and subsequent infection needs to be investigated further in in vivo animal and clinical studies.

Guidelines for Critical Limb Ischaemia and Diabetic Foot — Introduction

The European Society for Vascular Surgery appoints Guidelines Committees to write clinical practice guidelines for vascular surgery. Guidelines for the care of patients with critical limb ischaemia accompany this commentary. Guideline development was recommended in 1990 by the Institute of Medicine, to improve decision-making for specific patient circumstances, and to decrease the variability between healthcare providers.1,2 Appropriate decision-making is critical to achieving excellent outcomes. Guidelines have become more popular in surgery and medicine. This probably results from increased attention to evidence-based medicine, the desire for reproducibility in the choice of treatment for a specific patient, increasing government legislation, the need to satisfy insurance regulations, and legal pressures. Critical limb ischaemia (CLI) is a complex condition and there is significant variability in clinical practice, although a valid evidence base is available to guide recommendations. The significant increase in the volume of scientific literature concerning critical limb ischaemia published in recent years along with the number of technical and medical advances supports guideline recommendations with more certainty than before. Potential increases in healthcare costs and risks due to industry and the public-driven use of novel treatments, makes the current guidelines increasingly important.3––6 Many clinical situations of patients with critical limb ischaemia have not been the subject of randomised clinical trials. Patient care, however, needs to be delivered and decisions have to be made in these situations. Therefore, this document should also provide guidance for decisions where extensive Level 1 evidence is not available, and recommendations are determined on the basis of the currently available best evidence. By providing information about the relevance and quality of evidence, this document will enable the reader to locate the most important and evidence-based information relevant to the individual patient.7 To optimise the implementation of the current guideline document, its length has been kept as short as possible to enable easy access to its information. This document is supposed to be a guide, not a set of rules, and allows flexibility for specific patient circumstances.