A limited and customized follow-up seems justified after endovascular abdominal aneurysm repair in octogenarians.

OBJECTIVE: The objective of this study was to determine whether long-term follow-up after endovascular aneurysm repair (EVAR) is justified in octogenarians. METHODS: Between September 1996 and October 2011, all patients, including octogenarians, treated for an abdominal aortic aneurysm (AAA) by EVAR were included in a prospective database. Patients older than 80 years and with a nonruptured infrarenal aneurysm treated electively or urgently were included in the study (study group [SG]). Patients with ruptured aneurysms and patients who died during surgery or within the first postoperative month were excluded from further analysis. The control group (CG) consisted of patients younger than 80 years, matched for gender and AAA diameter. All patients were evaluated 4 to 8 weeks after EVAR and then annually thereafter. Follow-up data were complemented by review of the computerized hospital registry and charts and by contact of the patient's general practitioner or referring hospital. Primary outcomes were stent- or aneurysm-related complications and interventions. Secondary outcomes were additional surgical complications and patient survival. RESULTS: A total number of 193 patients (SG, n = 97; CG, n = 96) were included for analysis. Median age was 80 years, and 88.6% were male. Median follow-up time was 33.6 months (interquartile range [IQR], 12.9-68.3). Stent- and procedure-related postoperative complications were comparable between groups (SG, 41.2%; CG, 39.6%; P = .82). Median time to complication was 2.3 months (IQR, 0.2-19.4) in the SG compared with 18.1 months (IQR, 6.8-50.5) in the CG. The 2-year complication-free survival rates were 58% (SG) and 60% (CG). Interventions were performed significantly less frequently in octogenarians (SG, 8.2%; CG, 19.8%; P < .05). Median time to intervention was 11.1 months (IQR, 2.0-31.0) in the SG compared with 54.3 months (IQR, 15.0-93.2) in the CG. The 2-year intervention-free survival rates were 90% (SG) and 92% (CG). During follow-up, 98 patients died (SG, n = 54; CG, n = 44); median time to death was 31.8 months (IQR, 13.3-66.0) in the SG compared with 44.4 months (IQR, 15.0-77.7) in the CG. One aneurysm-related death occurred in the CG. The 2- and 5-year survival rates were 71% and 32% for the SG compared with 77% and 66% for the CG (P < .05). CONCLUSIONS: Because of the low incidence of secondary procedures and AAA-related deaths in octogenarians, long-term and frequent follow-up after EVAR seems questionable. An adapted and shortened follow-up seems warranted in this patient group.

Relation between B-mode gray-scale median and clinical features of carotid stenosis vulnerability.

BACKGROUND: Vulnerability of the carotid plaque might be useful as a predictor for ischemic stroke risk. The gray-scale median (GSM) of the carotid plaque at B-mode imaging has been described as an objective tool to quantify vulnerability. However, its use is disputed in the published literature. This study sought to validate the GSM as a predictor for carotid plaque vulnerability. METHODS: We included 89 consecutive patients (64 men; mean ± SD age: 68 ± 1 years) who were evaluated for carotid endarterectomy. The GSM was derived from preoperative B-mode images and related to the presence of clinical symptoms, the presence of ipsilateral infarction on neuroimaging, and to the number of intraoperative ipsilateral microemboli (ME) detected by transcranial Doppler ultrasonography. In addition, we combined the GSM with its standard deviation (GSM-SD), which we hypothesized to be a measure for plaque heterogeneity and thereby vulnerability. RESULTS: B-mode imaging revealed a wide variety in GSM among all plaques (median: 36; range: 6-89). The GSM could not be related to cardiovascular risk factors and was not different between symptomatic and asymptomatic patients (37.8 ± 8.9 vs 37.6 ± 17.1; P = 0.97). The GSM of plaques in patients with ipsilateral ischemic lesions on neuroimaging did also not differ from plaques in patients without (36.0 ± 14.6 vs 37.8 ± 16.9; P = 0.64). Finally, no relation between GSM and the presence of intraoperative ME (Spearman correlation; n = 73; ρ = 0.039; P = 0.75) was found. Combining GSM with its GSM-SD also could not identify more vulnerable plaques. CONCLUSIONS: No relation was found between the GSM and any clinical, radiologic, or intra- and postoperative neurologic phenomena. These data showed no additional value of the use of GSM in evaluating plaque vulnerability.

Safety and efficacy of carotid endarterectomy in octogenarians.

BACKGROUND: To evaluate the outcome of carotid endarterectomy (CEA) in octogenarians. METHOD: Between January 2005 and July 2010, all CEA patients were prospectively recorded. Patients were categorized into those <80 and ≥80 years of age. Primary outcome measures were hospital duration of stay (HDOS), mortality, any stroke, and postprocedural complications. RESULTS: In total, 477 patients with carotid artery stenosis were treated with CEA. Seventy-one patients (13%) were ≥80 years of age and 477 (87%) patients were <80 years of age. Median HDOS was 3.0 days (interquartile range [IQR], 2-5) for the entire cohort with a median of 3 days (IQR, 2-4) for patients <80 years of age and 4 days (IQR, 2-7) for patients ≥80 years of age (P = 0.0001). Fifteen patients (3%) had an early adverse neurologic event, with 7 patients (1.3%) developing a transient ischemic attack, 2 patients (0.3%) a minor stroke with full neurologic recovery, and 6 patients (1.1%) had a major stroke. Forty patients (6.8%) had a postoperative nerve injury. No statistical differences were observed between the younger (<80 years of age) and older (≥80 years of age) group despite a significant difference in postoperative delirium (P < 0.0001). During follow-up, more fatal cardiac events occurred in the octogenarians group (4.2% vs. 0.4%; P = 0.02). Kaplan-Meier analysis revealed a significantly better survival for the younger patients (log rank test; P = 0.04). CONCLUSIONS: Octogenarians who suffer from carotid artery stenosis can be safely treated by CEA. The increased incidence of postoperative delirium is an important finding and requires extra attention in this vulnerable group.

The relevance of aortic endograft prosthetic infection.

BACKGROUND: Vascular prosthetic graft infection is a severe complication after open aortic aneurysm repair. Reports of infected endografts are scarce. General treatment consensus with infected graft material is that it should be removed completely. The objective of this study was to describe the incidence of endograft infection after endovascular repair of abdominal (EVAR) and thoracic aortic aneurysm (TEVAR) and to report treatment options and their outcome. METHODS: A retrospective cohort study was performed of patients endovascularly operated for abdominal and thoracic aortic aneurysm in two large hospitals (one tertiary referral center and one large community hospital) between March 1996 and June 2009. Diagnosis of infected endograft was made based on clinical findings, blood tests and cultures, imaging studies (computed tomography, fludeoxyglucose positron emission tomography), and intraoperative findings at reoperation. RESULTS: Eleven patients with an infected endograft were identified in 1431 endovascular procedures. One other patient was referred from another hospital. Patients were aged 68 ± 9 years, and all but one were male. The median time from initial TEVAR/EVAR to the diagnosis of infection was 115 days (range, 7-3748 days), with 42% of patients presenting within 3 months after TEVAR/EVAR. Seven patients were diagnosed with endograft infection after elective TEVAR/EVAR and five after emergency TEVAR/EVAR. The incidence was significantly higher in patients that were treated in an emergency setting (0.56% vs 2.79%; P = .002), while there was no significant difference between TEVAR and EVAR procedures (1.37% vs 0.77%). All patients were initially treated with antibiotic therapy, which was complemented with surgical intervention in six patients. In four patients, the infected graft material was completely explanted. Isolated microorganisms included Staphylococcus species (n = 4), Streptococcus species (n = 4), Enterobacter cloacae (n = 1), Escherichia coli (n = 1), Pseudomonas aeruginosa (n = 1), and Listeria monocytogenes (n = 1). Median time of follow-up was 201 days (range, 6-2023 days). During the study period, three out of 12 patients died, of which two were treated conservatively (P = ns). At their last follow-up visit, seven of nine patients still used antimicrobial therapy. CONCLUSIONS: The incidence of endograft infection is below 1%, with a mortality rate of 25%. Although consensus is that infected graft material should always be removed, this study shows no significant difference in mortality between the conservatively- and the surgically-managed group, possibly related to the small sample size. There may be a role for conservative treatment in selected cases of patients with an infected endograft.

Effectiveness of treatment for octogenarians with acute abdominal aortic aneurysm.

OBJECTIVE: To investigate whether advanced age may be a reason to refrain from treatment in patients with an acute abdominal aortic aneurysm (AAAA). METHODS: This was a retrospective cohort study that took place in a tertiary care university hospital with a 45-bed intensive care unit. Two hundred seventy-one patients with manifest AAAA, admitted and treated between January 2000 and February 2008, were included. Six patients died during operation and were included in the final analysis to ensure an intention-to-treat protocol, resulting in 234 men and 37 women with a mean age of 72 ± 7.8 years (range, 54-88 years). Forty-six patients (17%) were 80 years or older. Interventions involved open or endovascular AAAA repair. RESULTS: Mean follow-up was 33 ± 30.4 months (including early deaths). Mean hospital length of stay was 16.9 ± 20 days for patients younger than 80 and 13 ± 16.7 days for patients older than 80 years of age. Kaplan-Meier survival analysis revealed a significantly better survival for the younger patients (P < .05). Stratification based on urgency or type of treatment did not change the difference. Two-year actuarial survival was 70% for patients younger than 80 and 52% for those older than 80. At 5-year follow-up, these figures were 62% and 29%, respectively. Mean survival in patients older than 80 was 39.8 ± 6.8 months versus 64.5 ± 3.0 months in those younger than 80. CONCLUSIONS: For octogenarians, our liberal strategy of treating patients with AAAA was associated with satisfactory short- and long-term outcome, with no difference with regard to disease- or procedure-related morbidity between the younger and older group. Assuming an integrated system for managing AAAA is in place, advanced age is not a reason to deny patients surgery.

Stent fractures in the Hemobahn/Viabahn stent graft after endovascular popliteal aneurysm repair.

OBJECTIVE: During the last decade, endovascular repair of popliteal artery aneurysms (PAAs) has become a valid alternative to open repair. This study analyzes the incidence and origin of stent graft fractures after endovascular repair, its impact on patency, and strategies to prevent fractures. METHODS: Data of 78 atherosclerotic PAAs in 64 patients were gathered in a prospectively-held database from 1998 to 2009. All x-rays were reviewed to detect stent fractures. Only circumferential fractures were included for analysis; localized strut fractures were excluded. Clinical endpoints were circumferential stent fracture, occlusion, and clinical status of the patient. RESULTS: Mean follow-up time was 50 months (range, 1-127 months). Fifteen circumferential stent fractures occurred in 13 (16.7%) patients. The majority of stent fractures (93.3%) were associated with the use of multiple stent grafts. At univariate analysis, younger age was identified as the only significant predictor for stent fracture (P = .007). The cumulative stent fracture-free survival was estimated at 78% and 73% at 5- and 10-year follow-up, respectively. The cumulative primary patency rate, defined as time to occlusion, was not different for the fracture group compared with the nonfracture group (P = .284). CONCLUSIONS: The incidence of stent fractures after endovascular PAA repair is probably underreported in the literature. Stent graft fractures mainly occur at overlap zones and are associated with younger age of the patient. Fracture of the stent did not significantly influence patency of the stent graft.

Mandibular subluxation for distal internal carotid artery exposure in edentulous patients.

Four patients with high internal carotid artery (ICA) occlusive disease were indicated for surgical endarterectomy and needed additional exposure besides regular head rotation and extension. When indicated, in our clinic this is usually achieved by mandibular subluxation with interdental wiring. Due to dental wear and periodontal disease, all 4 patients were edentulous. As a consequence, the technique of interdental wiring could not be used. In this technical note we will explain a method for interarch fixation with the use of two ipsilateral monocortical miniscrews and wiring, and the use of patients' pre-existing mandibular implants and provisional overdenture. This method gives rise to an additional exposure of 15 to 20 mm of the ICA.

A modified technique for iliac artery branched endografting using a "tromboned" sheath.

The iliac branched device (IBD) is the only totally endovascular option to preserve flow to the internal iliac artery for the treatment of aorto-iliac or solitary iliac artery aneurysms. This technique involves the use of two parallel guide wires, including the indwelling through-and-through wire and a wire to introduce the bridging stent-graft. We describe a technique which uses "tromboned" sheaths (ie, a 7F ANL 1 inside a 10F Balkin sheath) for increased cross-over stability and avoids problems associated with the use of parallel wires inside one sheath. In addition, reduction of the gap between the IBD and the origin of the internal iliac artery may result in a more stable position of the device.

Mortality of ruptured abdominal aortic aneurysm treated with open or endovascular repair.

OBJECTIVES: The study defined the selection criteria used for treatment of ruptured abdominal aortic aneurysms (RAAAs) and reviewed results during a 5-year period. METHODS: From 2002 on, our tertiary referral center adopted a protocol of selective use of endovascular repair for RAAAs. The study included all patients with a proven RAAA who were admitted to our hospital from 2002 to 2006. The primary outcome measure was surgical mortality. RESULTS: A total of 187 patients were admitted with an acute AAA, and an RAAA was confirmed 135 (72%) by computed tomography scanning or at laparotomy, and 125 (93%) were treated, 89 by open means and 36 by endovascular means. The overall mortality rate was 24% and the mortality rate was 13.9% for endovascular repair. Endovascular repair was consistently used more often in patients with favorable anatomy and in patients who were hemodynamically more stable. There were considerable differences in approach between the four consultant vascular surgeons. The overall evaluation and inclusion for endovascular treatment increased during the study period. CONCLUSIONS: A strict protocol for admission, evaluation, and treatment of RAAA, with selective use of endovascular repair, resulted in low mortality rates in our center.

A Case of Primary Aortoduodenal Fistula and Abdominal Aortic Aneurysm in a Patient with Chronic Q Fever.

A 70-year-old man was successfully treated for an aortoduodenal fistula originating from a Q fever-related abdominal aortic aneurysm. He had no known history of contact with cattle or sheep. Although the combination of abdominal aortic aneurysm and aortoduodenal fistula is rare, one should be suspicious of Q fever infection as the causative agent, and additional medical treatment should be initiated.

HLA-DR expression on monocytes and systemic inflammation in patients with ruptured abdominal aortic aneurysms.

INTRODUCTION: Mortality from ruptured abdominal aortic aneurysms (RAAA) remains high. Severe systemic inflammation, leading to multi-organ failure, often occurs in these patients. In this study we describe the level of HLA-DR expression in a consecutive group of patients following surgery for RAAA and compare results between survivors and non-survivors. A similar comparison is made for IL-6, IL-10 levels and SOFA-scores. METHODS: This is a prospective observational study. Patients with RAAA were prospectively analyzed. Blood samples were collected on day 1, 3, 5, 7, 10 and 14. The fraction of CD-14 positive monocytes expressing HLA-DR was measured by flow-cytometry. Interleukin-6 and interleukin-10 levels were measured by ELISA. RESULTS: Thirty patients with a median age of 70 years were included. There were 27 (90%) men. Six patients died from multiple organ failure, all other patients survived. The Sequential Organ Failure Assessment (SOFA) scores were significantly higher in non-survivors on day 1 through 14. HLA-DR expression on monocytes was significantly lower on day 3, 5, 7, 10 and 14 in non-survivors. Interleukin-6 and IL-10 levels were significantly higher in non-survivors on day 1 and day 1 and 3 respectively. CONCLUSIONS: HLA-DR expression on monocytes was decreased, especially in non-survivors. All patients with RAAA displayed a severe inflammatory and anti-inflammatory response with an increased production of IL-6 and IL-10. Poor outcome is associated with high levels of IL-6 and IL-10 and a high SOFA score in the first three days after surgery, while low levels of HLA-DR expression are observed from day three after RAAA repair.

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.

Peripheral nerve pathology in patients with severely affected complex regional pain syndrome type I.

Complex regional pain syndrome type I (CRPS-I) is a chronic pain syndrome with no clinical evidence of nerve injury; however, recently, changes in muscle tissue have been found in case of CRPS-I. Our aim was to search for histological changes in peripheral nerves of amputated limbs from patients with therapy-resistant CRPS-I that could justify muscle tissue changes. Fifteen patients with CRPS-I (duration >1 year) were included. Multiple nerve samples were taken from upper (n=4) and lower (n=11) amputated limbs. Histological changes (signs of nerve fiber loss and regeneration), fiber diameters, fiber diameter distribution, and fiber density were studied through microscopy and morphometry. Samples from three healthy sural nerves were used as control data as well as data from the literature. All patients (93% of tissue samples) showed histological signs of nerve fiber loss and fiber regeneration, varying in severity. No specific preference was found for any nerve or the location within the nerve. Sural nerves showed loss of especially larger nerve fibers (>12 µm) in comparison with control data. Sympathectomy did not influence this finding. The morphometric results of the other nerves are more difficult to interpret because of the absence of good-quality control data from the literature. However, the percentages of nerve fibers greater than 12 µm seem to lie within the normal range. Besides the known pathology of thin nerve fibers innervating the skin or blood vessels in CRPS-I, this study also shows pathological changes more proximal in the nerves, especially in the sural nerve.

Five years' world experience with nonpenetrating clips for vascular anastomoses.

BACKGROUND: A new sutureless technique has been introduced clinically to facilitate the process of vascular reconstruction and improve patency. The Vessel Closure System (VCS) is nonpenetrating, creates an elastomeric everted anastomosis, and is easily and reproducibly applied. The objective of this report is to review the published world experience that has accrued regarding these clips with attention to the assets, liabilities, and pitfalls associated with the new technology. DATA SOURCES: Medline search and manual cross-referencing were performed, after which 61 original articles were identified on the use of VCS clips for vascular anastomoses. RESULTS: Advantages of the clips compared with sutures include the technical ease of application, the reduced anastomotic time, the superior hemodynamics, and the improved healing pattern of the anastomosis. Disadvantages include the potential problems in atherosclerotic vessels, lack of prospective randomized long-term follow-up, and initial costs. The best clinical results have been achieved in microvascular repair, as well as with vascular access and transplantation surgery. CONCLUSIONS: The VCS clip technology has become an accepted vascular anastomosing technique, which in future could lead to the use of clips as a standard approach and the use of sutures only in case of severe atherosclerosis and other circumstances in which vessel edges are difficult to evert.

Evolution of staples and clips for vascular anastomoses.

Because of the development of less invasive surgical techniques, there is an increasing demand for vascular anastomosing techniques that require less exposure of the operating field. This paper reviews the most important representatives of staples, clips, and other mechanical devices for vascular anastomosing described over the last five decades. This report is organized in three parts: (1) the history of clipping and stapling devices, (2) development of the Vessel Closure System (VCS) clips, and (3) current and potential status of mechanical vascular anastomotic devices. A Medline literature search was conducted and publications on the use of staples and/or clips for the creation of vascular anastomoses identified with extensive cross-referencing. The first literature description of a mechanical vascular stapling device was by Gudov in 1950. This and other reports from the Soviet Union stimulated brisk, competitive development of vascular anastomotic devices in Europe, North America, and Japan. Fasteners included staples, penetrating pin-rings, or toothed stainless steel clips, none of which gained acceptance because of their complexity and inability to facilitate end-to-side anastomoses. A more convenient and less traumatic anastomotic system (VCS Clip applier system) was introduced into clinical practice in 1995. This system differs from staples in that it is non-penetrating. A wide variety of reports have described the advantages, both technical and biological, that clips provide over conventional needle-and-suture, particularly for the construction of vascular access for hemodialysis. A steady evolution of mechanical vascular anastomotic devices has sought to eliminate the technical and biological disadvantages of conventional suturing. Although the conventional hand-sewn, overcast non-absorbable suture remains the "gold" standard, newer techniques such as the non-penetrating arcuate-legged VCS clips are gaining acceptance as a useful addition to the vascular surgeons' armamentarium.

Reduction of residual limb volume in people with transtibial amputation.

The early postoperative phase after transtibial amputation is characterized by rapid residual limb volume reduction. Accurate measurement of residual limb volume is important for the timing of fitting a prosthesis. The aim of this study is to analyze the reduction of residual limb volume in people with transtibial amputation and to correlate residual limb volume with residual limb circumference. In a longitudinal cohort study of 21 people who had a transtibial amputation, residual limb volume was measured using a laser scanner and circumference was measured using a tape measure 1 wk postamputation and every 3 wk thereafter until 24 wk postamputation. A linear mixed model analysis was performed with weeks postamputation transformed according to the natural logarithm as predictor. Residual limb volume decreased significantly over time, with a large variation between patients. Residual limb volume does not correlate well with circumference. On average, residual limb volume decreased 200.5 mL (9.7% of the initial volume) per natural logarithm of the weeks postamputation. The decrease in residual limb volume following a transtibial amputation is substantial in the early postamputation phase, followed by a leveling off. It was not possible to determine a specific moment when the residual limb volume had stabilized.

Informed Decision-Making Regarding Amputation for Complex Regional Pain Syndrome Type I.

BACKGROUND: Literature on complex regional pain syndrome type I (CRPS-I) discussing the decision to amputate or not, the level of amputation, or the timing of the amputation is scarce. We evaluated informed decision-making regarding amputation for CRPS-I. METHODS: We describe our findings in a retrospective study of the decision-making process of thirty-six patients who underwent amputation for CRPS-I at our university medical center from 2000 to 2012. Additionally, we present the incidents preceding the CRPS-I, the reasons for and the levels of the amputation, and the outcomes after the amputations. RESULTS: Team members and the patient decided together whether or not to amputate and the level of amputation. Issues such as level of pain or allodynia, infection, desired length of the residual limb, joint range of motion, strength of all extremities, ability to use walking aids, and psychological "green, yellow, and red flags" were weighed in this process. There were no complications during the amputation surgery, a 22% rate of complications (infection in all but one patient) immediately postoperatively (reamputation not required), a 72% rate of phantom pain immediately after or within the first three months after the amputation, and a 77% rate of phantom pain more than one year after the amputation. CONCLUSIONS: Informed decision-making regarding amputation for CRPS-I remains a complex process for which little evidence is available to support patient choices; patient-specific outcomes are not predictable. However, amputation should not be ignored as a treatment option for long-standing therapy-resistant CRPS-I. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

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.