Expanding use of nonpenetrating clips in various surgical specialities.

The Anastoclip Vessel Closure System (VCS) (LeMaitre Vascular, Burlington, MA, USA), introduced primarily to facilitate microvascular anastomoses performed during neurosurgical extra-intracranial bypasses, has been used for several other applications as well. The relatively new anastomotic technique includes a clip applier, clip remover, and everting forceps. With the applier, tiny nonpenetrating titanium clips were installed on everted walls of tubular structures. The technical ease of application, reduced anastomotic time, superior hemodynamics, and an improved healing pattern at the anastomosis have been recognized as major advantages compared to conventional suturing. This chapter describes the various indications for use of the system and categorizes them by specific surgical specialties, which include neurosurgery, urology, and gynecology, as well as plastic and reconstructive, vascular, thoracic, transplantation, hepatopancreaticobiliary, and orthopedic and trauma surgery. The largest clinical experience with clips is in vascular access surgery for hemodialysis purposes, both in autologous constructs and with prosthetic grafts. Promising clinical results also have been achieved in neurosurgical cases (both for microvascular anastomoses and with closure of dura mater), microvascular free-tissue transfer, and renal and liver transplantations. Future clinical applications include the use of clips for nerve repair and closure of various types of tubular structures using a laparoscopic approach.

Cyanoacrylate skin microsealant for preventing surgical site infection after vascular surgery: a discontinued randomized clinical trial.

BACKGROUND: Surgical site infections (SSI) after vascular surgery are related to substantial morbidity. Restriction of bacterial access to the site of surgery with a cyanoacrylate sealant is a new concept. We performed a randomized clinical trial to assess the effect of the sealing of skin with a cyanoacrylate preparation at the site of surgery on the incidence of SSI after arterial reconstruction. METHODS: Patients scheduled for vascular reconstruction in or distal to the groin were randomized into a treatment and a control group. Standard measures for preventing contamination of the surgical field were taken in the control group, whereas cyanoacrylate was used as a skin sealant at the surgical site in the patients in the treatment group. We hypothesized that the incidence of SSI with the use of cyanoacrylate would be two-thirds (67%) lower than that with standard preparation of the surgical site, and performed an interim analysis of 50 patients to assess this. RESULTS: Risk factors among the 50 patients in the study included smoking (28%), hypertension (77%), diabetes mellitus (36%), and hypercholesterolemia (74%). Indications for surgery were invalidating claudication (Fontaine IIb), pain at rest, or tissue necrosis. The overall incidence of SSI was 3/47 (6%), without differences between groups; 9% SSIs in the control group versus 4% SSIs in the intervention group. CONCLUSION: We could not confirm a reduction in the incidence of SSI after inguinal vascular surgery with the use of a cyanoacrylate skin sealant as compared with conventional means for preparing the surgical site.

Critical factors in the translation of improved antimicrobial strategies for medical implants and devices.

Biomaterials-associated infection incidence represents an increasing clinical challenge as more people gain access to medical device technologies worldwide and microbial resistance to current approaches mounts. Few reported antimicrobial approaches to implanted biomaterials ever get commercialized for physician use and patient benefit. This is not for lack of ideas since many thousands of claims to new approaches to antimicrobial efficacy are reported. Lack of translation of reported ideas into medical products approved for use, results from conflicting goals and purposes between the various participants involved in conception, validation, development, commercialization, safety and regulatory oversight, insurance reimbursement, and legal aspects of medical device innovation. The scientific causes, problems and impressive costs of the limiting clinical options for combating biomaterials-associated infection are well recognized. Demands for improved antimicrobial technologies constantly appear. Yet, the actual human, ethical and social costs and consequences of their occurrence are less articulated. Here, we describe several clinical cases of biomaterials-associated infections to illustrate the often-missing human elements of these infections. We identify the current societal forces at play in translating antimicrobial research concepts into clinical implant use and their often-orthogonal constituencies, missions and policies. We assert that in the current complex environment between researchers, funding agencies, physicians, patients, providers, producers, payers, regulatory agencies and litigators, opportunities for translatable successes are minimized under the various risks assumed in the translation process. This argues for an alternative approach to more effectively introduce new biomaterials and device technologies that can address the clinical issues by providing patients and medical practitioners new options for desperate clinical conditions ineffectively addressed by biomedical innovation.

Biomaterial-associated infection: locating the finish line in the race for the surface.

Biomaterial-associated infections occur on both permanent implants and temporary devices for restoration or support of human functions. Despite increasing use of biomaterials in an aging society, comparatively few biomaterials have been designed that effectively reduce the incidence of biomaterial-associated infections. This review provides design guidelines for infection-reducing strategies based on the concept that the fate of biomaterial implants or devices is a competition between host tissue cell integration and bacterial colonization at their surfaces.

Conservative treatment of vascular prosthetic graft infection is associated with high mortality.

BACKGROUND: The aim of this study was to identify patient-related and/or disease-related factors that influence outcomes in patients with vascular prosthetic graft infections. METHODS: Through the hospital patient administration system, between January 1997 and December 2007, a total of 44 patients were diagnosed with central prosthetic graft infections. Univariate and multivariate analyses were performed to define factors predictive of mortality. RESULTS: Thirty-three men and 11 women (mean age, 71 years) were included. There was considerable comorbidity. Coagulase-negative Staphylococcus and S aureus were isolated in almost 50% of the patients. The mean follow-up duration was 5 years, during which 20 patients (46%) died. The main causes of death were related to vascular disease. Conservative treatment with antibiotics was the only variable with significant predictive value on multivariate analysis (hazard ratio, 3.62; 95% confidence interval, 1.17-11.24; P = .02). CONCLUSIONS: Conservative treatment of prosthetic graft infections was associated with high mortality; therefore, it should be limited to a specific group. Patients who are not capable of undergoing open repair may benefit from conservative management. Otherwise, aggressive open treatment seems indicated.