Advantages And Disadvantages Of Endoscopic Sinus Surgery

Thursday, January 27, 2022 9:30:21 PM

Advantages And Disadvantages Of Endoscopic Sinus Surgery

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Expected benefits and risks from Sinus Surgery - Peter Hellings

Potential device-related risks include stretching or tearing of the device, stiffness, chronic synovitis or effusion, prolonged post-operative rehabilitation, delayed or failed incorporation of the device as well as immunological reaction. Moreover, the porcine surgical mesh implant is contraindicated in patients with massive chronic rotator cuff tears that cannot be mobilized, or where the muscle tissue has undergone substantial fatty degeneration. Fibrin glue has been used to treat anorectal fistulas in an attempt to avoid more radical surgical intervention. Fibrin glue treatment is simple and repeatable; failure does not compromise further treatment options; and sphincter function is preserved.

However, reported success rates vary widely. Suturable bioprosthetic plugs Surgisis, Cook Surgical, Inc. Surgisis is a new 4- or 8-ply bioactive, prosthetic mesh for hernia repair derived from porcine SIS. In a review on resorbable extra-cellular matrix grafts in urological reconstruction, Santucci and Barber noted that recent problems with inflammation following 8-ply pubo-vaginal sling use and failures after 1- and 4-ply SIS repair of Peyronie's disease underscore the need for research before wide adoption.

In a prospective cohort study, Johnson and Armstrong compared fibrin glue versus the anal fistula plug. Patients with high trans-sphincteric fistulas, or deeper, were prospectively enrolled. Patients with Crohn's disease or superficial fistulas were excluded. Age, gender, number and type of fistula tracts, and previous fistula surgeries were compared between groups. Under general anesthesia and in prone jack-knife position, the tract was irrigated with hydrogen peroxide. Fistula tracts were occluded by fibrin glue versus closure of the primary opening using a Surgisis anal fistula plug. A total of 25 patients were prospectively enrolled: 10 patients underwent fibrin glue closure, and 15 used a fistula plug.

Patient's age, gender, fistula tract characteristics, and number of previous closure attempts was similar in both groups. The authors concluded that closure of the primary opening of a fistula tract using a suturable biologic anal fistula plug is an effective method of treating anorectal fistulas. The method seems to be more reliable than fibrin glue closure. The greater efficacy of the fistula plug may be the result of the ability to suture the plug in the primary opening, therefore, closing the primary opening more effectively. These investigators noted that further prospective, long-term studies are warranted. A guidance document from the National Institute for Health and Clinical Excellence NICE, found insufficient evidence to support the use of porcine intestinal submucosa plugs for repair of anorectal fistula.

The NICE assessment concluded: "Current evidence suggests that there are no major safety concerns associated with the closure of anal fistula fistula in ano using a suturable bioprosthetic plug. However, evidence on the efficacy of the procedure is not adequate for it to be used without special arrangements for consent and for audit or research. All patients with peri-anal Crohn's disease suffering from trans-sphincteric and recto-vaginal fistulas who underwent surgery using the Surgisis R anal fistula plug or the Surgisis R mesh were prospectively enrolled in this study. Inclusion criteria included trans-sphincteric single-tract fistulas and recto-vaginal fistulas.

Success was defined as closure of both internal and external peri-anal or vaginal openings, absence of drainage without further intervention, and absence of abscess formation. Follow-up information was obtained from clinical examination 3, 6, 9, and 12 months post-operatively. Within the observation period, a total of 16 procedures were performed. All 4 patients with failure had re-operation. No deterioration of continence was documented. The authors concluded that the short-term success rates are promising; further analysis is needed to explain the definite role of this technique in comparison with traditional surgical techniques.

Safar et al analyzed the efficacy of the Cook Surgisis AFP anal fistula plug for the management of complex anal fistulas. This was a retrospective review of all patients prospectively entered into a database at the authors' institution who underwent treatment for complex anal fistulas using Cook Surgisis AFP anal fistula plug between July and July Patient's demographics, fistula etiology, and success rates were recorded. The plug was placed in accordance with the inventor's guidelines.

Success was defined as closure of all external openings, absence of drainage without further intervention, and absence of abscess formation. A total of 35 patients underwent 39 plug insertions 22 men; mean age of 46 range of 15 to 79 years. Three patients were lost to follow-up, therefore, 36 procedures to be analyzed. The fistula etiology was crypto-glandular in 31 There were 11 smokers and 3 patients with diabetes. The overall success rate was 5 of 36 In 17 patients, further procedures were necessary as a result of failure of treatment with the plug.

The reasons for failure were infection requiring drainage and seton placement in 8 patients The authors concluded that the success rate for Surgisis AFP anal fistula plug for the treatment of complex anal fistulas was They stated that further analysis is needed to explain significant differences in outcomes. Autologous Iliac Crest Bone Grafting ICBG is considered the gold-standard graft choice for spinal arthrodesis; however, it is associated with donor site morbidity and a limited graft supply. Demineralized bone matrix products are a class of commercially available grafting agents that are prepared from allograft bone.

There is some evidence for the use of demineralized bone matrix products in spinal fusions as an alternative to allograft. Cammisa, et al. A total of patients underwent posterolateral spine fusion with pedicle screw fixation and bone grafting. An independent, blinded reviewer evaluated anteroposterior and lateral flexion-extension radiographs. The fusion mass lateral to the instrumentation on each side was judged fused or not, and the mineralization of the graft was rated absent, mild, moderate, or extensive. The degree of correspondence in outcomes between sides was estimated by computing the percentage agreement and kappa statistic.

Bone mineralization ratings also were similar between treated sides. The authors concluded that Grafton DBM can extend a smaller quantity of autograft than is normally required to achieve a solid spinal arthrodesis. Consequently, a reduced amount of harvested autograft may be required, potentially diminishing the risk and severity of donor site complications. Kang, et al. An independent radiologist evaluated plain radiographs and computed tomographic scans at 6-month, 1-year, and 2-year time points. Similar improvements in the physical component summary scores were seen in both the Grafton and ICBG groups. Aghdasi, et al. The authors found that demineralized bone matrix has been evaluated in animal models and human clinical trials of spine fusion.

Results of animal studies indicate variation in performance within and among demineralized bone matrix products. The majority of human clinical trials report high fusion rates when DBM is employed as a graft extender or a graft enhancer. The authors found that few prospective randomized controlled trials have been performed comparing DBM to autologous iliac crest bone graft in spine fusion. The authors concluded that, although many animal and human studies demonstrate comparable efficacy of DBM when combined with autograft or compared to autograft alone, additional high level of evidence studies are required to clearly define the indications for its use in spine fusion surgeries and the appropriate patient population that will benefit from DBM.

It is injected into osseous defects that are created surgically or as a result of trauma. The paste cures in-situ, resorbs, and then is replaced with bone during the healing process. The cured paste provides a temporary support media for bone fragments during the surgical procedure but does not provide structural support during the healing process. Injection of MIIG is usually performed in conjunction with another procedure, such as reduction of a fracture.

Minimally invasive injectable graft was cleared by the FDA through the k process since it is substantially equivalent to other bone void fillers on the market. Combined with bone marrow aspirate, Integra Mozaik OS is intended for use as a bone void filler of the skeletal system in the extremities, spine, and pelvis. Integra Mozaik OS putty was cleared by the FDA through the k process since it is substantially equivalent to another bone void filler on the market.

According to the FDA k letter to the manufacturer, it is specifically indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the body void or gap defect , Integra Mozaik putty is resorbed and replaced with bone during the healing process. There is insufficient evidence to support the use of MIIG, Integra Mozaik OS putty, or other bone void fillers as a treatment for delayed union or nonunions. Furthermore, a technology assessment prepared by ECRI for Agency for Healthcare Research and Quality concluded that there is no reliable evidence to support the use of calcium sulphate or other bone void fillers as treatments for delayed fracture healing.

A retrospective case series examined the use of AlloMatrix injectable putty in nonunions in multiple bone types Wilkins and Kelly, The publication did not report prior treatment or the duration of the nonunions prior to the AlloMatrix putty treatment. A technology assessment prepared by the ECRI Institute Schoelles et al, for the Agency for Healthcare Research and Quality, commenting on this study, stated that "[w]ithout this information, interpretation of the results is difficult". The study also did not report whether all consecutively treated patients were included or if dropouts occurred during the treatment period. A subsequent study by Ziran and colleagues reported on an unacceptably high rate of complications with the use of Allomatrix for nonunions.

Patients were monitored for healing and adverse effects, which included local or systemic reactions, wound problems, infection, and any secondary surgery caused by graft complications. Eleven patients with deep infections also required surgical treatment of drainage. Other analyses were not performed because of the small sample size, which was because of early termination of the study. The investigators concluded that the use of Allomatrix putty as an alternative for autogenous bone graft in the treatment of nonunions resulted in an unacceptably high rate of complications.

The investigators stated: "[a]lthough we recommend further study, we do not recommend the use of Allomatrix for the treatment of nonunions, especially if there is a large volumetric defect or a history of any prior contamination of the tissue bed". Mesenchymal stem cells or MSCs are multipotent stem cells that can differentiate into a variety of cell types. Mesenchymal stem cells have been classically obtained from the bone marrow, and have been shown to differentiate into various cell types, including osteoblasts, chondrocytes, myocytes, adipocytes, and neuronal cells.

Helm and colleagues stated that although autologous bone remains the gold standard for stimulating bone repair and regeneration, the advent in molecular biology as well as bioengineering techniques has produced materials that exhibit potent osteogenic activities. Recombinant human osteogenic growth factors e. They noted that the delivery of MSCs, derived from adult bone marrow, to regions requiring bone formation is also compelling, and it has been shown to be successful in inducing osteogenesis in many pre-clinical animal studies.

Finally, the identification of biological and non-biological scaffolding materials is a crucial component of future bone graft substitutes, not only as a delivery vehicle for bone growth factors and MSCs, but also as an osteo-conductive matrix to stimulate bone deposition directly. Recently, MSCs has been studied for its use in orthopedic application e. Acosta et al noted that although important obstacles to the survival and proliferation of MSCs within the degenerating intervertebral disc need to be overcome, the potential for this therapy to slow or reverse the degenerative process remains substantial. Leung et al stated that in the past several years, significant progress has been made in the field of stem cell regeneration of the intervertebral disc.

Autogenic MSCs in animal models can arrest intervertebral disc degeneration or even partially regenerate it, and the effect is suggested to be dependent on the severity of degeneration. Mesenchymal stem cells are able to escape alloantigen recognition which is an advantage for allogenic transplantation. A number of injectable scaffolds have been described and various methods to pre-modulate MSCs' activity have been tested. They noted that more work is needed to address the use of MSCs in large animal models as well as the fate of the implanted MSCs, especially the long-term outcomes.

Mclain et al noted that successful arthrodesis in challenging clinical scenarios is facilitated when the site is augmented with autograft bone. The iliac crest has long been the preferred source of autograft material, but graft harvest is associated with frequent complications and pain. Connective tissue progenitor cells aspirated from the iliac crest and concentrated with allograft matrix and demineralized bone matrix provide a promising alternative to traditional autograft harvest.

The vertebral body, an even larger reservoir of myeloproliferative cells, should provide progenitor cell concentrations similar to those of the iliac crest. Aspirates were obtained from two depths within the vertebral body and were quantified relative to matched, bilateral aspirates from the iliac crest that were obtained from the same patient at the same time.

Histochemical analysis was used to determine the prevalence of vertebral progenitor cells relative to the depth of aspiration, the vertebral level, age, and gender, as compared with the iliac crest standard. Aspirates of vertebral marrow demonstrated comparable or greater concentrations of progenitor cells compared with matched controls from the iliac crest. With the numbers available, there were no significant differences relative to vertebral body level, the side aspirated, the depth of aspiration, or gender. An age-related decline in cellularity was suggested for the iliac crest aspirates.

The authors concluded that the vertebral body is a suitable site for aspiration of bone marrow for graft augmentation during spinal arthrodesis. They also stated that future clinical studies will attempt to confirm the ability to obtain fusion using only this source of connective tissue progenitor cells. Anderson and colleagues reviewed the rationale and discussed the results of cellular strategies that have been proposed or investigated for disc degeneration. These investigators noted that although substantial work remains, the future of cellular therapies for symptomatic disc degeneration appears promising.

They concluded that continued research is warranted to further define the optimal cell type, scaffolds, and adjuvants that will allow successful disc repair in human patients. Risbud and colleagues evaluated the osteogenic potential of MSCs isolated from the bone marrow of the human vertebral body VB. Marrow samples from VB of patients undergoing lumbar spinal surgery were collected; marrow was also harvested from the iliac crest IC. Progenitor cells were isolated and the number of colony forming unit-fibroblastic CFU-F determined. The osteogenic potential of the cells was characterized using biochemical and molecular biology techniques.

Moreover, progenitor cells from the VB exhibited an increased level of alkaline phosphatase activity. VB and IC cells mineralized their extracellular matrix to a similar extent. Progenitor cells isolated from both sites respond in a similar manner to an osteogenic stimulus and express common immunophenotypes. Based on these findings, these researchers proposed that progenitor cells from the lumbar vertebral marrow would be suitable candidate for osseous graft supplementation in spinal fusion procedures.

They stated that studies must now be conducted using animal models to ascertain if cells of the VB are as effective as those of the IC for the fusion applications. This technique may yield a more consistent quality of fusion bone as compared to that with autograft. They stated that these results are encouraging and warrant further studies with the suitable dose of BMP-2 and basic FGF, and may provide a rational basis for their clinical application. AlloStem is partially demineralized allograft bone combined with adipose derived mesenchymal stem cells; it is similar to autograft bone. Hankemeier et al noted that the optimal operative therapy for the treatment of osteochondritis dissecans tali is still controversial.

Beside bone marrow-stimulating techniques like abrasion arthroplasty, drilling and microfracturing, new techniques like autologous osteochondral transplantation and autologous chondrocyte transplantation are increasingly used. This study reviewed the clinical, radiological and subjective long-term outcome of bone marrow-stimulating therapy for 45 ankles with an osteochondritis dissecans tali stage 3 or 4 according to the classification by Berndt and Harty. All ankles were treated by the removal of the dissecate and abrasion of the subchondral bone.

The average maximum size of the lesion was 1. At follow-up examination, Obesity, age older than 40 years and pre-operative osteoarthritic changes had a significant negative impact on the clinical outcome. Autologous chondrocyte transplantation and osteochondral autografts yield encouraging 2- and 4-year results, but still have to prove their superiority in long-term follow-up studies.

Kon et al stated that osteochondritis dissecans is a relatively common cause of knee pain. These researchers described the outcomes of five different surgical techniques in a series of 60 patients with osteochondritis dissecans. Sixty patients aged The global mean IKDC score improved from No influence of age, lesion size, duration of follow-up, or previous surgical procedures on the result was found.

The authors concluded that all of the techniques were effective in achieving good clinical and radiographic results in patients with osteochondritis dissecans, and the effectiveness of autologous chondrocyte implantation was confirmed at a mean follow-up of 5 years. Newer techniques such as MaioRegen implantation and the "1-step" transplantation technique are based on different rationales; the first relies on the characteristics of the scaffold and the second on the regenerative potential of mesenchymal cells. Both of these newer procedures have the advantage of being minimally invasive and requiring a single operation.

They retrospectively reviewed 23 patients between 12 and 21 years of age mean of Twenty patients had autologous chondrocyte implantation and 3 patients had cultured bone marrow stem cell implantation. There were 19 males and 4 females. These investigators obtained pre-operative CT scans to assess patella subluxation, tilt, and congruence angle to determine choice of treatment. They obtained IKDC subjective knee evaluation scores, Tegner-Lysholm activity levels, and Lysholm-Gillquist knee scores pre-operatively and at 6, 12, and 24 months post-operatively.

Complications include periosteal hypertrophy observed in 2 patients. The authors concluded that cell-based therapy was associated with short-term improvement in function in adolescents and young adults with patellar OCD. Only 3 patients received cultured bone marrow stem cell implantation. Further investigation is needed to study the value of MSC therapy in orthopedic applications before it can be used in the clinical setting.

Cheng et al had previously isolated and identified stem cells from human anterior cruciate ligament ACL. The purpose of this study was to evaluate the differences in proliferation, differentiation, and extracellular matrix ECM formation abilities between bone marrow stem cells BMSCs and ACL-derived stem cells LSCs from the same donors when cultured with different growth factors, including basic fibroblast growth factor bFGF , epidermal growth factor, and transforming growth factor-beta 1 TGF-beta1.

Ligament tissues and bone marrow aspirate were obtained from patients undergoing total knee arthroplasty and ACL reconstruction surgeries. Proliferation, colony formation, and population doubling capacity as well as multi-lineage differentiation potentials of LSCs and BMSCs were compared. Gene expression and ECM production for ligament engineering were also evaluated. It was found that BMSCs possessed better osteogenic differentiation potential than LSCs, while similar adipogenic and chondrogenic differentiation abilities were observed. Steinert et al noted that when ruptured, the ACL of the human knee has limited regenerative potential. However, the goal of this report was to show that the cells that migrate out of the human ACL constitute a rich population of progenitor cells and these researchers hypothesized that they display mesenchymal stem cell MSC characteristics when compared with adherent cells derived from bone marrow or collagenase digests from ACL.

Staining for STRO-1 was seen by immunohistochemistry but not flow cytometry. Under suitable culture conditions, the ACL outgrowth-derived MSCs differentiated into chondrocytes, osteoblasts, and adipocytes and showed capacity to self-renew in an in vitro assay of ligamentogenesis. MSCs derived from collagenase digests of ACL tissue and human bone marrow were analyzed in parallel and displayed similar, but not identical, properties.

In situ staining of the ACL suggests that the MSCs reside both aligned with the collagenous matrix of the ligament and adjacent to small blood vessels. The authors concluded that the cells that emigrate from damaged ACLs are MSCs and that they have the potential to provide the basis for a superior, biological repair of this ligament. According to information from the manufacturer, BIO MatrX Structure is a highly porous, synthetic bone graft substitute that sets hard upon implantation for a complete defect fill.

The manufacturer states that the resulting osteoconductive scaffold provides inter-connected porosity and high surface area to facilitate cell mediated remodeling and new bone growth. BIO MatrX Generate is a combination of osteoconductive nano-crystalline calcium phosphate and Demineralized Bone Matrix DBM that is tested for osteoinductive potential by lot, after sterilization, in an in-vivo athymic nude rodent muscle pouch model. The viscous putty sets hard after closure providing an osteoconductive scaffold to facilitate new bone growth. The manufacturer states that both materials are FDA-cleared to be hydrated with saline or blood; and are indicated as bone void fillers of the pelvis, extremities and the postero-lateral spine.

The use of minced cartilage techniques are in the early stages of development. According to the manufacturer, DeNovo NT was developed as a consequence of the need for expanded treatment options for the treatment of cartilage lesions. Louis, MO , and exclusively distributed by Zimmer, Inc. Warsaw, IN. DeNovo NT consists of manually minced cartilage tissue pieces obtained from juvenile allograft donor joints. The tissue fragments are mixed intra-operatively with fibrin glue before implantation.

It is thought that mincing the tissue helps with cell migration. As there are no chemicals used and minimal manipulation, it is regulated as an allograft tissue rather than a biological implant. Thus, the allograft tissue does not require FDA approval for marketing. DeNovo NT is currently available in the U. Neocartilage uses juvenile allogeneic cartilage cells that are isolated and expanded in-vitro, similar to other ACI techniques.

Neocartilage is currently being studied in human clinical trials under an FDA-approved investigational new drug IND application. There are no studies evaluating the DeNovo ET tissue graft in the published medical literature. There are few studies evaluating the DeNovo NT graft in the published medical literature. The manufacturer of DeNovo NT has initiated a post-market, multi-center, longitudinal data collection study to collect clinical outcomes of subjects implanted with DeNovo NT. Data are to be obtained either retrospectively or prospectively from patients implanted or to be implanted with DeNovo NT for the treatment of lesion in the ankle. Data to be collected include details of the operative procedure as well as subjects' pain, function, activity levels, and healthcare resource use through a 5-year post-operative follow-up period.

Four U. A retrospective chart review of patients treated with Cook and Gore fistula plugs between August and December was performed. Success was defined as closure of all external openings and absence of drainage and abscess formation. Twelve Cook patients underwent 16 plug insertions and 10 Gore patients underwent 11 plug insertions. The overall procedural success rate in the Gore group was The reasons for failure were unknown in the majority of patients and plug dislodgement in 2 patients.

These short-term results with the Gore fistula plug suggested a higher procedural success rate in comparison to the Cook plug. The authors concluded that patients should be cautioned regarding potentially high failure rates; however, longer follow-up and a larger patient population are needed to confirm significant differences in fistula plug efficacy. Elsheikh et al analyzed the results obtained from HA bone cement repair of ossicular discontinuity between the incus and stapes during surgery of retraction pockets.

A total of 62 previously untreated patients 82 ears with retraction pockets were studied. Hydroxyapatite bone cement was used to repair defects at the incudo-stapedial connection in 82 ears with retraction pockets. The ears were divided into 2 groups: group 1 included 48 ears with a small defect in the long process of the incus; group 2 included 34 ears with a large defect in the long process of the incus.

In addition, 20 control patients underwent surgery using Plastipore partial ossicular replacement prostheses. Hearing results were reported in 4 frequencies 0. Analysis of the results was performed using the paired t-test with significance level at 0. Main outcome measures were anatomic and audiologic results. Significant post-operative improvement of pure-tone air conduction threshold averages and air-bone gap ABG averages were reported in the 3 studied groups.

The authors concluded that bone cement ossiculoplasty offered cost-effective and significant improvement in conductive hearing loss. It provided an excellent alternative to ossiculoplasty with preformed prostheses. They believed the indications for bone cement were validated by these results. Redaelli de Zinis et al reported hearing results using a titanium ossicular replacement prosthesis during canal wall down mastoidectomy with tympanoplasty to treat cholesteatoma.

Patients with cholesteatoma treated with primary or revision canal wall down mastoidectomy with tympanoplasty in a single-stage. Patients with implanted HA prostheses composed a matched control group. Medical records were reviewed for type of ossicular condition, type of prosthesis, and hearing threshold at 1-year follow-up. Results were reported as the 5-frequency average air conduction gain, bone conduction gain, and ABG. The malleus handle was present in 24 patients, and the stapes superstructure in 22 patients. Mean SD air conduction gain was 7.

Bone conduction gain was 1. No patients experienced post-operative impairment of bone threshold greater than 5 dB. Post-operative air-bone gap was The authors concluded that titanium is a satisfactory material for use in ossicular reconstruction and is comparable to HA, although at present, no definitive conclusion about the superiority of titanium can be drawn. This status of the ossicular chain is one of the reasons that ossiculoplasty for tympano-sclerotic stapes fixation is more difficult than that for oto-sclerosis. These investigators conducted a retrospective review of 7 patients who were operated on for tympano-sclerotic stapes fixation between and Post-operative hearing results were assessed in all 7 patients after at least 1 year.

The post-operative ABG was closed within 10 dB in 2 of 7 patients, and was less than 20 dB in 6 of 7 patients. There was almost no hearing improvement at high frequencies 4 and 8 kHz. There were no patients with post-operative SNHL. Van Rompaey et al studied hearing outcome in revision stapedotomy cases where extensive erosion of the long process of the incus was observed in a consecutive series where a malleo-vestibular prosthesis was used versus a consecutive series where HA bone cement was used to re-build the eroded long process of the incus and integrate the prosthesis.

This study examined a total of 20 revision cases of surgically treated oto-sclerosis where extensive incus erosion was observed during revision surgery. In the earlier consecutive series, 10 cases were treated with malleo-vestibular prostheses. In the later consecutive series, 10 cases were treated with HA bone cement to re-build the incus-prosthesis interface. Air-bone gap, bone-conduction thresholds, and air-conduction thresholds were evaluated pre-operatively and at 1 to 3 months.

Last audiometry available also was reported median of 12 months. Pure-tone averages were calculated according to the guidelines of the Committee on Hearing and Equilibrium for the evaluation of conductive hearing loss. Raw data were displayed in an Amsterdam Hearing Evaluation Plot. Six male patients and 14 female patients were included. Age varied from 34 to 75 years median of 53 years.

The median post-operative ABG at last follow-up audiometry was No short-term or intermediate-term adverse reactions or unsuspected bone conduction deteriorations were seen. The authors concluded that HA bone cement can be successfully used to reconstruct the long process of the incus in case of extensive erosion of the long process. Intermediate-term hearing outcome is comparable to the outcome of a series of similar cases treated with malleo-vestibular prostheses.

Because the placement of a malleo-vestibular prosthesis is technically more difficult and presents a high risk to the inner ear, the authors thought HA bone cement can be a useful alternative in these difficult cases. Somers et al compared the hearing outcome using HA bone cement to bridge the incudo-stapedial gap versus incus re-modelling for ossiculoplasty in case of incudo-stapedial discontinuity.

A non-randomized retrospective study was conducted at a tertiary referral otologic center. The intervention in 24 primary cases of conductive hearing loss was subsequent middle ear inspection where incudo-stapedial discontinuity was observed. Hydroxyapatite bone cement was used in 10 consecutive cases, and incus re-modelling was performed in 14 consecutive cases. Air-bone gap, bone-conduction BC thresholds, and air-conduction AC thresholds were evaluated pre-operatively and at 3, 6 and 12 months post-operatively.

No patients were lost to follow-up. The Amsterdam Hearing Evaluation Plots are presented. However, these researchers observed a statistically significant difference in ABG gain at 6 and 12 months favoring the HA bone cement cases. No short-term or intermediate-term adverse reactions were observed. The authors concluded that HA bone cement bridging ossiculoplasty offers a better intermediate-term ABG gain than standard ossiculoplasty. This new technique is a valuable alternative to conventional ossiculoplasty and presents the practical advantage of being easier and faster. Ayshford et al noted that nasal septal perforations present a distinct challenge to the otolaryngologist and a significant cause of symptoms to affected patients.

Many surgical techniques for the repair of septal perforations have been described. Connective tissue autografts are commonly used as inter-positional grafts between the septal flaps. Recently acellular human dermal allograft has been used with success. In this study, a total of 17 patients with symptomatic anterior nasal septal perforations that had failed conservative treatment underwent a closed endoscopic repair of their perforations with acellular human dermal allograft Alloderm and an anteriorly based inferior turbinate flap; 13 patients had a successful closure of the perforation, 2 patients, despite initial success, re-perforated as a result of persistent crust picking and, in 2 patients, the graft failed.

The authors concluded that with appropriate patient selection and stringent post-operative care this technique offers a good surgical outcome for the closure of septal perforations. The findings of this small study need to be validated by well-designed studies. Chhabra and Houser noted that the closure of nasal septal perforations can be challenging based on the etiology, location, and method of closure. These researchers reported on a novel method of closure for nasal septal perforations using a unilateral mucosal rotational flap and acellular dermal interposition graft.

A total of 20 patients with nasal septal perforations of various etiologies underwent this novel method of repair through a closed, endonasal approach. Of 20 patients, 19 were completely asymptomatic following surgical intervention, and of the 3 with failed repairs, only 1 patient required revision surgery for persistent symptoms. The authors concluded that nasal septal perforations may cause bothersome symptoms and present a significant reconstructive challenge. Native septal tissue is advantageous due to a rich vascular supply and proximity to the defect, while interposition grafts act as a scaffold for the migration of respiratory mucosa.

Outcomes for patients treated with impaction grafting have demonstrated promising results. The objective Knee Society Score after a mean follow-up of approximately four years range of two to eight years was 89 range of 70 to , and the functional score was 81 range of 50 to None of the patients were revised. A total of 54 consecutive patients underwent surgery for idiopathic scoliosis using the same technique -- 30 received a graft consisting of a mixture of cortico-cancellous autologous and allogenic bone frozen at degrees, and 24 patients were grafted with a mixture of cortico-cancellous autologous bone and sticks of tri-calcium phosphate TCP, Biosorb, SBM, Lourdes, France.

All patients were seen at 3, 6 and 12 months, then once a year for at least 4 years with clinical and radiological evaluation at each visit. At the final follow-up visit, no radiologic signs of pseudoarthrosis were found in either group with a minimum follow-up of 4 years. The appearance of bone callus was considered satisfactory at 6 months in all cases; moreover callus seemed to be more important in the TCP series, although this assessment was subjective. Tri-calcium phosphate resorption was total after 2 years, while allograft fragments were visible on x-rays after 2 years.

Minor mechanical complications occurred but did not influence the results. Loss of correction did not progress after 6 months in the TCP group and after 2 years in the allograft group. Based upon this experience, the use of synthetic bone substitutes such as TCP would appear to be a valuable alternative to allografts in postero-lateral spinal arthrodesis for idiopathic scoliosis, and it would eliminate the risk of viral contamination inherent to allograft implantation. The authors stated that there had been no previous comparative studies concerning the use of TCP versus allograft in the literature.

Kanayama et al evaluated the osteo-inductive property of OP-1 or BMP-7 and fusion rate in human instrumented postero-lateral lumbar fusion through radiographic examination, surgical exploration, and histologic assessment. A total of 19 patients with L3 to L4 or L4 to L5 degenerative spondylolisthesis underwent postero-lateral lumbar fusion using pedicle screw instrumentation.

The patients were randomized to receive either OP-1 putty 3. Fusion status was evaluated using plain radiography and CT scan. Radiographic fusion criteria included less than 5 degrees of angular motion, less than 2 mm of translation, and evidence of bridging bone in the postero-lateral lumbar area in which the graft materials were placed following decortication. After a minimum 1-year follow-up, the patients who showed radiographic evidence of fusion underwent instrumentation removal and surgical exploration of the fusion site. Biopsy specimens were taken from the fusion mass and evaluated histologically.

Radiographic fusion rate was 7 of 9 OP-1 patients and 9 of 10 control patients. Histologic assessment demonstrated viable bone in 6 of 7 OP-1 patients. The authors concluded that in a human postero-lateral lumbar spine trial, OP-1 reliably induced viable amounts of new bone formation, but the fusion success rate evaluated by surgical exploration was only 4 of 7. In the posterior correction of scoliosis, local bone resected as part of the procedure is used as the base bone graft material.

Supplemental grafting from the iliac crest is considered the gold-standard in posterior spinal fusion. However, autograft is not available in unlimited quantities, and bone harvesting is a source of significant morbidity. A total of 40 patients with adolescent idiopathic scoliosis AIS were randomized into 2 treatment groups and underwent corrective posterior instrumentation. If thoracoplasty was performed, the resected rib bone was added in both groups.

Patients were observed clinically and radiographically for a minimum of 20 months post-operatively, with a mean follow-up of 4 years. Overall pain and pain specific to the back and donor site were assessed using a visual analog scale VAS. As a result, both groups were comparable with respect to the age at the time of surgery, gender ratio, pre-operative deformity, and hence length of instrumentation.

There was no significant difference in blood loss and operative time. In 9 patients of the b-TCP group and 8 patients of the ICBG group, thoracoplasty was performed resulting in a rib graft of on average 7. Average curve correction was Loss of curve correction amounted on average 2. One patient in the b-TCP group was diagnosed with a pseudarthrosis at the caudal end of the instrumentation.

Revision surgery demonstrated solid bone formation directly above the pseudarthrosis with no histological evidence of b-TCP in the biopsy taken. They stated that the promising early results of this pilot study supported that b-TCP appears to be an effective bone substitute in scoliosis surgery avoiding harvesting of pelvic bone and the associated morbidity. Larsson noted that a number of different calcium phosphate compounds such as calcium phosphate cements and solid b-TCP products have been introduced during the past 10 years. The chemical composition mimics the mineral phase of bone and as a result of this likeness, the materials seem to be re-modeled as for normal bone through a cell-mediated process that involves osteoclastic activity.

This is a major difference when compared with, for instance, calcium sulphate compounds that after implantation dissolve irrespective of the new bone formation rate. Calcium phosphates are highly biocompatible and in addition, they act as synthetic osteo-conductive scaffolds after implantation in bone. When placed adjacent to bone, osteoid is formed directly on the surface of the calcium phosphate with no soft tissue interposed. Re-modeling is slow and incomplete, but by adding more and larger pores, like in ultraporous b-TCP, complete or nearly complete resorption can be achieved. The indications explored so far include filling of metaphyseal fracture voids or bone cysts, a volume expander in conjunction with inductive products, and as a carrier for various growth factors and antibiotics.

The authors concluded that calcium phosphate compounds e. Larsson and Hannink stated that more than a decade has passed since the first injectable bone substitutes were introduced for use in orthopedic trauma, and over recent years the number of commercial products has increased dramatically. Despite the fact that these bone substitutes have been on the market for many years, knowledge among potential users on how and when they might be useful is still fairly limited. Most injectable bone substitutes belong to one of two major groups: by far the largest group contains products based on various calcium phosphate CP mixtures, whilst the smaller group consists of calcium sulphate CS compounds.

Following mixing, the CP or CS paste can be injected into--for instance--a fracture space for augmentation as an alternative to bone graft, or around a screw for augmentation if the bone is weak. Within minutes an in-situ process makes the substitute hard; the mechanical strength in compression resembles that of cancellous bone, whereas the strength in bending and shear is lower. Over time, CP products undergo re-modelling through a cell-mediated process that seems to mimic the normal bone re-modelling, while CS products are dissolved through a faster process that is not cell-mediated.

For CP, a number of clinical studies have shown that it can be useful for augmentation of metaphyseal fractures when a space is present. Randomized studies have verified that CP works especially well in tibial plateau fractures when compared with conventional bone grafting. So far the number of clinical studies on CS products is very low. Development at present seems to be heading towards premixed or directly mixed products as well as new compounds that contain fibers or other components to enhance bending and shear strength.

Products that are based on combinations of CP and CS are also being developed to combine the fast-dissolving CS with the stronger and more slowly re-modelling CP. Injectable bone substitutes, and especially CS, have also been targeted as potentially good carriers for antibiotics and growth factors. In summary, there is currently a lack of good quality RCTs on the use of ceramic-based products e.

Buchberg et al noted that treatment of complex anal fistulas presents an ongoing challenge to colorectal surgeons. The anal fistula plug is an attractive definitive option due to its minimal risk of incontinence, simple design, and easy application. The authors concluded that patients should be cautioned regarding potentially high failure rates; moreover, they stated that longer follow-up and a larger patient population are needed to confirm significant differences in fistula plug efficacy. O'Riordan et al summarized the anal fistula plug literature for Crohn's and non-Crohn's fistula-in-ano in a homogenous patient population. Studies were included if results for patients with and without Crohn's disease could be differentiated.

Patients with recto-vaginal, ano-vaginal, recto-urethral, or ileal-pouch vaginal fistulas were excluded as were studies where the mean or median follow-up was less than 3 months. Two researchers independently selected studies matching the inclusion criteria. The primary outcomes measured were the overall fistula closure rates and length of follow-up. A total of 76 articles or abstracts were identified from the title as being of relevance; 20 studies 2 abstracts, 18 articles were finally included. Study sample size ranged from 4 to 60 patients; patients were included in all studies non-Crohn's and 42 Crohn's patients. The plug extrusion rate was 8. The proportion of patients achieving fistula closure varied widely between studies for non-Crohn's, ranging from 0.

The pooled proportion of patients achieving fistula closure in patients with non-Crohn's fistula-in-ano was 0. The proportion achieving closure in patients with Crohn's disease was similar 0. The anal fistula plug has not been adequately evaluated in the Crohn's population. Abrams et al stated that osteochondritis dissecans lesions occur frequently in children and adolescents. Treatment can be challenging and depends on the status of the articular cartilage and subchondral bone. Injection of calcium phosphate bone substitute into the area of subchondral bone edema Subchondroplasty; Knee Creations, West Chester, PA may be an option. These researchers presented a case of a lateral tibial plateau osteochondritis dissecans lesion treated with subchondral injection of nanocrystalline calcium phosphate.

Pre-operative magnetic resonance imaging is used to determine the area of subchondral edema, and intra-operative fluoroscopy is used to localize this area with the injection cannula. Calcium phosphate is injected by use of a series of syringes until the appropriate fill is obtained. Treatment of concomitant cartilage defects may also be carried out at this time. The authors noted that potential challenges in using this technique are accurate localization of the lesion intra-operatively. Fluoroscopy is often not able to show the lesion at the time of the procedure. Because of this, these investigators regularly had the pre-operative MRI scan available in the operating room for reference to be able to properly match the location of the cannula with the area of maximal T2 signal intensity based on the MRI scan.

In addition, when this technique is used in skeletally immature individuals, there is the potential for physeal injury because of the proximity of the calcium phosphate. The findings of this single case study need to be validated by well-designed studies. AlloStem is partially demineralized allograft bone combined with adipose derived mesenchymal stem cells. Shin et al noted that focal chondral lesions of the glenohumeral joint, though less common than chondral defects in the knee or ankle, can be a significant source of pain in an active population.

For patients in whom non-surgical management fails, promising results have been reported after arthroscopic microfracture surgery to treat such lesions. However, microfracture leads to growth of fibrocartilage tissue and is biomechanically less durable than native hyaline cartilage. Recently, augmentation of the microfractured defect with micronized allogeneic cartilage and PRP has been described to restore hyaline-like cartilage and potentially protect the subchondral bone from post-surgical fracture biology within the base of the defect.

In a single-case study, these investigators presented a simple arthroscopic technique of implanting dehydrated, micronized allogeneic cartilage scaffold to treat an isolated chondral lesion of the glenoid. This criterion was not included in the AAO-HNS guideline for adult rhinosinusitis [ 13 ], but was included in the consensus recommendations by Meltzer et al [ 42 ]. More stringent criteria of patient selection based on duration as well as characteristic progression of the clinical course should improve the differentiation of ABRS from viral rhinosinusitis and identify the patient population most likely to benefit from empiric antimicrobial therapy.

Adoption of more stringent clinical criteria for the diagnosis of ABRS may result in delay of appropriate antimicrobial therapy in some patients. However, more accurate distinction will be made between bacterial vs viral rhinosinusitis, and the overuse of antibiotics will be minimized. Reserving antimicrobial therapy for patients with severe or prolonged manifestation of ABRS fails to address quality of life or productivity issues in patients with mild or moderate symptoms of ABRS. Radiographic confirmation of sinus disease for patients with uncomplicated ABRS is not necessary and is not advised. The clinical differentiation of bacterial from viral acute rhinosinusitis remains problematic without direct sinus aspiration and culture.

Additional RCTs of antibiotic vs placebo in adult patients meeting stringent clinical criteria as outlined above are urgently needed. Such studies should incorporate both pre- and posttherapy sinus cultures to provide critical information regarding the natural history of sinus infection and efficacy of antimicrobial therapy. The use of endoscopic middle meatus cultures in lieu of sinus aspiration should be further evaluated for this purpose. Because adoption of more stringent clinical criteria based on characteristic onset and clinical presentations is more likely to identify patients with bacterial rather than acute viral rhinosinusitis, withholding or delaying empiric antimicrobial therapy is not recommended. Prompt initiation of antimicrobial therapy as soon as the clinical diagnosis of ABRS is established as defined in recommendation 1 should shorten the duration of illness, provide earlier symptomatic relief, restore quality of life, and prevent recurrence or suppurative complications.

However, as discussed earlier in this review, the high spontaneous resolution rate in these placebo-controlled RCTs is most certainly due to less stringent patient selection and the inclusion of patients who had viral rather than true ABRS. Thus, a watchful waiting strategy is only reasonable if one is uncertain about the diagnosis of ABRS owing to mild symptoms but cannot be recommended when more stringent clinical criteria for the diagnosis of ABRS are applied. Prompt antimicrobial therapy for patients more likely to have acute bacterial rather than viral rhinosinusitis should shorten the duration of illness, provide earlier symptom relief, restore quality of life, and prevent recurrent infection or suppurative complications. Prompt antimicrobial therapy may result in overuse of antibiotics, enhanced cost, and risk of adverse effects in those patients who do have true bacterial infection but mild disease.

However, the patient selection criteria specified in recommendation 1 make this possibility less likely. Such patients require close observation; antimicrobial therapy should be initiated promptly after 3 days if there is still no improvement. More placebo-controlled RCTs that incorporate both pre- and posttherapy sinus cultures and a clinical severity scoring system are urgently needed to provide critical information regarding the natural history of ABRS as well as the timeliness and efficacy of antimicrobial therapy. The recommendation that amoxicillin-clavulanate rather than amoxicillin alone be considered as first-line therapy for ABRS is based on 2 observations: 1 the increasing prevalence of H.

Although earlier studies that compared amoxicillin to amoxicillin-clavulanate did not find a superior outcome with amoxicillin-clavulanate [ 62 , 64 ], these studies were performed in an era when both the prevalence of H. In contrast, both the prevalence of H. The microbiology of acute sinusitis in children obtained by sinus puncture is summarized in Table 6.

The data were analyzed according to reports published prior to and more recently in The microbiology of ABRS in children was last studied in detail in [ 81 ], and no current data are available. Thus, more recent data were extrapolated from middle ear fluid cultures of children with acute AOM in the post—pneumococcal vaccine era [ 84 , 86 , 91 ]. Whereas S. Ampicillin resistance among H. Data compiled from [ 87—89 ]. Data compiled from [ 81 , 90 ].

Data from [ 45 ]. Data extrapolated from middle ear fluid of children with acute otitis media [ 86 , 91 ]. Primarily in odontogenic infections [ 92 ]. The addition of clavulanate to amoxicillin substantially improves the coverage for both ampicillin-resistant H. The combination of clavulanate with amoxicillin for empiric therapy of ABRS adds to the cost, increased likelihood of adverse effects due to diarrhea, and rare instances of hypersensitivity reaction due to clavulanate.

Therapy with an oral antibiotic may be initiated 24 hours later, provided the vomiting has resolved. Continued surveillance of antimicrobial susceptibility profiles of all respiratory pathogens both regional and national should be performed at regular intervals to guide initial empiric antimicrobial therapy. Thus, the recommendation of choosing amoxicillin-clavulanate over amoxicillin as first-line therapy for ABRS in adults is relatively weak. Furthermore, although M. Nevertheless, in a recent study in adults that examined the microbiology of ABRS by sinus puncture [ 45 ], H. Interestingly, similar to the case with AOM in children, the introduction of conjugated pneumococcal vaccines also had a significant impact on the frequency of recovery of both H.

Brook et al [ 97 ] obtained middle meatus cultures from adults with ABRS between and prevaccination and patients between and postvaccination. The recovery of S. The addition of clavulanate to amoxicillin will improve the coverage of both ampicillin-resistant H. The addition of clavulanate to amoxicillin adds to the cost of antibiotics, a potential increased risk of diarrhea, and rare instances of hypersensitivity reaction due to clavulanate. Standard-dose amoxicillin-clavulanate is recommended as first-line therapy for ABRS in both children and adults. However, this regimen is inadequate for PNS S.

The prevalence of these isolates in the United States is currently unknown. Continued surveillance of antimicrobial susceptibility profiles of all respiratory pathogens should be performed both nationally and regionally. High-dose amoxicillin is preferred over standard-dose amoxicillin primarily to cover PNS S. Increased resistance among PNS S. The frequency of PNS S. Higher susceptibility profiles for S. In addition, introduction of the valent pneumococcal conjugated vaccine PCV13 in may further decrease the prevalence of invasive pneumococcal infections including those caused by some PNS S.

This would suggest that unless the endemic rate of PNS S. There are no clinical data in the literature that compared the efficacy of high-dose vs standard-dose amoxicillin, either with or without clavulanate, in the treatment of children or adults with ABRS. However, there is indirect evidence to support high-dose amoxicillin-clavulanate as initial empiric therapy of ABRS among patients with increased risk factors for PNS S. There are also theoretical advantages of high-dose amoxicillin in the empiric treatment of ABRS. Against S. Amoxicillin-clavulanate also achieved the highest cumulative fraction of response against H. Apart from PNS S. Clinicians should be alert to the possibility of such isolates, although reports in the United States are limited.

The main disadvantages of high-dose amoxicillin-clavulanate are the added cost and potential for more adverse effects. Until a clear need for high-dose amoxicillin-clavulanate is demonstrated by unacceptably high failure rates from standard-dose amoxicillin-clavulanate, delaying the use of high-dose amoxicillin-clavulanate as empiric therapy for all patients with presumed ABRS may be more cost-effective and result in fewer adverse effects and less antibiotic selection pressure for resistance. It should be noted that the prevalence of resistant or intermediate S. This is evidenced by the shift in S. Protection against serotype 19A disease has been documented in a PCV13 vaccine effectiveness study [ 99 ]. Thus, decisions regarding appropriate dosing regimens should be guided by antimicrobial susceptibility profiles of prevalent pathogens through diligent surveillance by local or national reporting agencies.

More studies are needed to directly compare the cost-effectiveness of high-dose vs standard-dose amoxicillin-clavulanate as initial empiric antimicrobial therapy of presumed ABRS in both adults and children. The respiratory fluoroquinolones both levofloxacin and moxifloxacin have remained highly active against all common respiratory pathogens, including PNS S. The comparator agents in these trials were amoxicillin-clavulanate in 5, cefuroxime in 2, and cefdinir in 1. Specifically, in a subset analysis of 5 studies that evaluated the efficacy of the respiratory fluoroquinolones moxifloxacin, levofloxacin, or gatifloxacin there was no difference in clinical outcomes compared with amoxicillin-clavulanate or cefuroxime.

Patient or population: patients with acute sinusitis. Settings: initial therapy. Intervention: FQ. Only 5 of 11 studies included; only those comparing respiratory fluoroquinolones are included. A limitation of these RCTs is that none evaluated high-dose amoxicillin-clavulanate as a comparator; accordingly, it is not possible to directly assess any difference between a respiratory fluoroquinolone and the currently recommended first-line agents for patients with severe infection or those at risk for PNS S. It is also possible that high-dose amoxicillin-clavulanate may result in more adverse effects compared with a fluoroquinolone. It is likely that each of the study arms included patients with a viral rather than bacterial infection.

Thus, the role of respiratory fluoroquinolones for the empiric treatment of moderate to severe infection in ABRS remains to be determined. At present, respiratory fluoroquinolones should be reserved for those who have failed to respond to first-line agents, those with a history of penicillin allergy, and as second-line therapy for patients at risk for PNS S. This recommendation places a relatively high value on limiting the development of antibiotic resistance and resource use. Fluoroquinolones are associated with a variety of adverse effects including central nervous system events seizures, headaches, dizziness, sleep disorders , peripheral neuropathy, photosensitivity with skin rash, disorders of glucose homeostasis hypoglycemia and hyperglycemia , prolongation of QT interval, hepatic dysfunction, and skeletomuscular complaints.

Limiting the overuse of fluoroquinolones may slow the development of resistance against this class of antimicrobial agents. The role of the respiratory fluoroquinolones in the initial empiric treatment of ABRS in an era of increasing antimicrobial resistance remains uncertain. Appropriately powered RCTs that directly compare the efficacy, adverse effects, and cost-benefit of the respiratory fluoroquinolones vs high-dose amoxicillin-clavulanate are warranted. Second- and third-generation oral cephalosporins are no longer recommended for empiric monotherapy of ABRS owing to variable rates of resistance among S. Combination therapy with a third-generation oral cephalosporin cefixime or cefpodoxime plus clindamycin may be used as second-line therapy for children with non—type I penicillin allergy or those from geographic regions with high endemic rates of PNS S.

Because RCTs have not found significant differences in response rates to various antimicrobial regimens for ABRS [ 24 , 44 ], selection of alternative antimicrobial agents is primarily based on known prevalence of respiratory pathogens in the community, antimicrobial spectrum including PNS S. Cross-resistant and multidrug-resistant S. Accordingly, antimicrobial agents previously recommended as an alternative to amoxicillin or amoxicillin-clavulanate, such as macrolides, TMP-SMX, or second- or third-generation oral cephalosporins, can no longer be recommended because of increasing resistance among S.

The prevalence of macrolide-resistant S. Macrolide resistance among S. Although the association between in vitro resistance and adverse clinical outcome in acute rhinosinusitis remains generally unproven owing to lack of microbiological documentation , treatment failure associated with erm B-mediated resistance in bacteremic pneumococcal disease has been well documented [ ]. In light of these findings, macrolides are no longer recommended for empiric antimicrobial therapy of S. Although telithromycin remains highly active against all respiratory isolates including penicillin-resistant S. Harrison et al [ 94 ] evaluated the susceptibility to common pediatric antibiotics among S. Similarly, among H. Doxycycline has remained active against all common respiratory pathogens, although there are few published reports for recent isolates in the United States [ , ].

Data from national surveys in Canada reveal that doxycycline is highly active against all recent respiratory pathogens Zhanel, University of Manitoba, Winnipeg; written communication, August [ , ]. However, the rate of cross-resistance to doxycycline among PNS S. A recent prospective double-blind trial of doxycycline vs levofloxacin in the treatment of hospitalized patients with community-acquired pneumonia demonstrated similar clinical response rates and length of stay but at a significantly lower cost for doxycycline [ ]. These data support the recommendation of doxycycline for the outpatient treatment of community-acquired pneumonia in the IDSA guideline [ ]. There are only 5 RCTs of doxycycline for ABRS in the English literature since , including 2 placebo-controlled trials [ 46 , ] and 3 comparative trials with brodimoprim, spiramycin, and loracarbef, respectively [ — ].

Of the 3 comparative trials, only the Scandinavian study enrolled sufficient patients [ ]. In this double-blind, randomized study, patients were enrolled and both pre- and posttreatment sinus punctures were performed. A different organism was isolated from posttreatment cultures in 4 2. The significance of these posttreatment cultures is difficult to interpret since they do not always correlate with the clinical response. The in vitro activity of second- and third-generation oral cephalosporins such as cefaclor, cefprozil, cefuroxime axetil, cefpodoxime, cefdinir, and cefixime are highly variable particularly against penicillin-intermediate and resistant S. Among these oral cephalosporins, cefpodoxime, cefuroxime axetil, and cefdinir are moderately active against penicillin-intermediate S.

Oral cephalosporins including cefpodoxime and cefdinir are inactive against penicillin-resistant S. Intravenous ceftriaxone and cefotaxime remain active against nearly all S. Cefpodoxime is the most active oral cephalosporin against both H. Cefaclor and cefprozil are least active Table 7. Based on these in vitro data, it is clear that considerable variability exists in the activity of second- and third-generation oral cephalosporins, particularly against S.

For this reason, these agents are no longer recommended as monotherapy for the initial empiric treatment of ABRS in children or adults. If an oral cephalosporin is to be used, a third-generation cephalosporin eg, cefixime or cefpodoxime in combination with clindamycin is recommended for patients with ABRS from geographic regions with high endemic rates of PNS S. However, clindamycin resistance is reported frequently among S. In such instances, a fluoroquinolone levofloxacin or moxifloxacin is recommended as an alternative. The recommended first-line and second-line regimens for empiric antimicrobial therapy of ABRS in children and adults are summarized in Tables 9 and 10 , respectively.

Abbreviations: bid, twice daily; IV, intravenously; PO, orally; qd, daily; tid, 3 times a day. Doxycycline appears more cost-effective than the respiratory fluoroquinolones. Third-generation oral cephalosporins eg, cefixime or cefpodoxime are well tolerated with minimal adverse effects. However, their coverage for S. The respiratory fluoroquinolones are more costly than doxycycline, and escalating resistance with increased usage is a concern.

Similar to other fluoroquinolones, moxifloxacin has been associated with severe hepatotoxicity [ , ]. Oral third-generation cephalosporins are relatively costly and may cause diarrhea or hypersensitivity reactions. Clindamycin is an important cause of Clostridium difficile— associated enterocolitis, and clindamycin resistance is common among S. The introduction and large-scale implementation of PCV7 has led to the emergence of more virulent and resistant nonvaccine serotypes such as serotype 19A [ 86 , ]. The introduction of PCV13, which contains 6 additional serotype antigens including serotype 19A, is anticipated to decrease both overall and resistant invasive pneumococcal disease [ 99 ]. However, ongoing surveillance is required to detect the possibility of other emerging nonvaccine serotypes of PNS S.

Doxycycline should be included in national and regional surveillance studies of respiratory pathogens, and more RCTs with this antimicrobial agent in the empiric treatment of adults with ABRS are warranted. Among the third-generation oral cephalosporins, cefditoren appears to have the best intrinsic activity against all common respiratory pathogens including PNS S.

In patients with a questionable history of penicillin allergy, skin testing is strongly recommended to confirm or exclude an immediate hypersensitivity response. If an immunoglobulin E—mediated immediate-type hypersensitivity response is documented, a respiratory fluoroquinolone levofloxacin, moxifloxacin or doxycycline is recommended for adults. The respiratory fluoroquinolones remain highly active against all common pathogens in ABRS and their ability to rapidly eradicate bacteria from the maxillary sinuses is well established [ , ]. For children with a history of immediate-type hypersensitivity response, levofloxacin is recommended as an alternative to amoxicillin-clavulanate, because experience with moxifloxacin in children is relatively scant and doxycycline is not recommended due to staining of teeth.

Although use of levofloxacin in children is currently approved by the US Food and Drug Administration FDA only for patients following inhalational exposure to anthrax [ ], its safety profile in children has been studied extensively [ — ]. The safety and tolerability of levofloxacin in children was assessed prospectively among children who participated in several randomized but nonblinded efficacy trials in the Pediatric Levaquin Program [ ].

Levofloxacin was well tolerated during and for 12 months following therapy as evidenced by a similar incidence and character of adverse events in children receiving levofloxacin compared with those who received nonfluoroquinolone antibiotics. However, the incidence of musculoskeletal events tendonopathy, arthritis, or arthralgia involving weight-bearing joints was greater in levofloxacin-treated children at 2 months 1. Similarly, the safety profile of ciprofloxacin in children was assessed prospectively among children enrolled in several randomized double-blind efficacy trials.

Although the difference was not statistically significant, the rate of arthropathy at 6 weeks among children who received ciprofloxacin was higher than among children who received a nonfluoroquinolone comparator both at 6 weeks 9. Achilles tendon rupture, a known complication associated with the use of fluoroquinolone antibiotics in adults, is extremely rare in the pediatric population. The American Association of Pediatrics recently issued a policy statement concerning the use of fluoroquinolones in several pediatric infections, including conjunctivitis, respiratory tract infections, and gastrointestinal and urinary tract infections [ ].

It was concluded that use of a fluoroquinolone in a child or adolescent may be justified in situations where there is no safe and effective alternative. In light of these findings, the recommendation that levofloxacin be used as an alternative to amoxicillin-clavulanate in children with immediate-type hypersensitivity reactions to penicillin appears warranted. For children with a history of non—type I hypersensitivity reaction to penicillin, a third-generation oral cephalosporin eg, cefixime or cefpodoxime in combination with clindamycin is recommended. The former is active against most strains of H. However, clindamycin resistance has been reported frequently among S.

In such instances, levofloxacin is recommended as an alternative. There is inadequate experience with cefditoren monotherapy for ABRS in children at this time. The recommended regimens for empiric antimicrobial therapy of ABRS in children and adults with a history of penicillin allergy are summarized in Tables 9 and 10 , respectively. Doxycycline is a cost-effective alternative to the respiratory fluoroquinolones in adults who cannot tolerate amoxicillin-clavulanate. The long-term safety of respiratory fluoroquinolones in children requires further evaluation. Every effort should be made to document such reactions with appropriate skin testing.

The increasing prevalence of PNS and cross-resistant S. Additional studies of the safety and efficacy of respiratory fluoroquinolones and monotherapy with cefditoren for ABRS in children are warranted. Payne et al [ ] performed a meta-analysis on the recovery rates of S. A total of 16 trials involving study patients reported in the English literature during — were included for analysis. Furthermore, these rates were somewhat inflated because they were based on the percentage of patients with positive sinus cultures. When the total numbers of enrolled patients are considered, the recovery rate of S. Brook et al [ ] and Huang and Hung [ ] also performed prospective studies by sinus puncture or culture of the middle meatus from patients with ABRS during — Recovery rates of S.

The corresponding recovery rates for MRSA were 2. Previous antimicrobial therapy, recent hospitalization and a history of nasal surgery were the most important risk factors for recovery of MRSA from sinus cultures [ ]. However, because the nose is a well-known reservoir for S. The concordance of results from sinus tap and middle meatus cultures does not eliminate this possibility as inadvertent contamination may occur by either specimen collection technique.

In support of this notion, 7 of the 16 patients with MRSA reported by Huang and Hung were also positive for other well-established respiratory pathogens, and all patients recovered despite the fact that 6 of them received inadequate antimicrobial therapy for MRSA. Because both S. In the meta-analysis cited above [ ], it is unclear whether quantitative cultures were performed in the various studies included for analysis. Collectively, these data do not refute the contention that S. However, in severely ill patients with clinical manifestations suggestive of orbital or intracranial extension of infection, and hospitalized patients with nosocomial sinusitis associated with prolonged nasal intubation, empiric coverage for MRSA while awaiting confirmation from positive cultures of the sinus or middle meatus would appear reasonable.

More stringent criteria for establishing a causative role of S. Obtaining cultures of the middle meatus or sinus aspirates may not be well tolerated in children. MRSA is an important pathogen both in the community and the healthcare setting. Accurate diagnosis of MRSA rhinosinusitis with microbiological confirmation is critical for appropriate antimicrobial therapy. More studies are needed to document the utility of endoscopically guided cultures of the middle meatus for distinguishing true infection from contamination by commensal flora. Existing clinical guidelines for ABRS generally recommend a course of antimicrobial therapy for 10—14 days, primarily on the basis of the duration of therapy in various RCTs [ 25 ].

Some investigators have recommended that antimicrobial therapy be continued for 7 days beyond the resolution of symptoms [ ]. Kutluhan and colleagues [ ] prospectively evaluated the duration of antimicrobial therapy and its effect on the nasal smears obtained from 4 patient groups with acute maxillary sinusitis who received antibiotics for 7, 14, 21, or 28 days. In all patients, the microbiology of maxillary sinusitis was confirmed by sinus puncture, and antibiotics were selected based on in vitro susceptibility. These authors concluded that the most appropriate duration of antimicrobial therapy for acute maxillary sinusitis was at least 2 weeks, because a significant difference in the neutrophil counts of nasal smears was observed in the study groups between 7 and 21 days of antimicrobial therapy.

However, neutrophil count in nasal smears is a poor criterion of responsiveness to antimicrobial therapy. In other clinical trials, no significant difference in clinical resolution rates was observed among patients receiving 6—10 days vs 3—5 days of various antimicrobial regimens [ — ]. A recent meta-analysis by Falagas et al [ ] examined the efficacy and safety of short vs longer courses of antimicrobial therapy for adults with ABRS enrolled in 12 RCTs.

No statistical difference in efficacy was noted between short-course 3—7 days vs long-course 6—10 days antibiotic therapy OR, 0. In addition, no differences in microbiological efficacy OR, 1. However, if only the studies that compared 5 days short-course vs 10 days long-course were included 5 RCTs , adverse effects were significantly fewer in the short-course treatment groups OR, 0. This meta-analysis has a number of limitations. There was overlap in the duration of short-course 3—7 days vs long-course 6—10 days treatment groups. Last, the concomitant administration of adjunctive medications may have minimized any real differences between the treatment groups in the various trials Table A major concern raised from earlier published RCTs is that the favorable outcome of shorter duration of treatment might be attributed to inclusion of patients without microbiological confirmation of ABRS.

Only 3 studies with a microbiological endpoint, variation in use of concomitant therapy. The duration of treatment for 5—7 days is chosen somewhat arbitrarily and is intermediate in the range of literature recommendations, which varies from 3—5 days, to 5—7 days, to 6—10 days [ ]. This recommendation is considered reasonable since in most patients with confirmation of ABRS by sinus puncture, both symptomatic improvement and bacteriological eradication from the maxillary sinus can be expected within 72 hours after initiation of appropriate antimicrobial therapy see question XIV following.

In any event, duration of antimicrobial therapy beyond 10 days in adult patients with uncomplicated ABRS is likely excessive. Data in pediatric patients, however, are inconclusive because the efficacy of shorter courses of therapy has not been specifically studied in a rigorous randomized fashion [ ]. Short courses of antimicrobial therapy may offer several advantages over longer courses of therapy including improved patient compliance, fewer adverse events, decreased bacterial antibiotic resistance, and lower cost [ , , — ]. Shorter courses of antimicrobial therapy may result in relapse or recurrent infection, particularly among the elderly and those with underlying disease or who are immunocompromised. Most clinical trials of antimicrobial therapy in ABRS have excluded severely ill patients and have focused exclusively on acute maxillary sinusitis with little information on patients with involvement of other sinuses.

Further research is needed regarding the optimal duration of antimicrobial treatment in children and adults in whom the likelihood of a viral URI has been minimized by adhering to stringent clinical inclusion criteria. Intranasal saline irrigations with either physiologic or hypertonic saline are recommended as an adjunctive treatment in adults with ABRS weak, low-moderate.

There is limited evidence in support of physiologic or hypertonic saline irrigations as adjunctive therapy for patients with ABRS. A recent Cochrane review evaluated the efficacy of saline nasal irrigations in treating acute URIs including acute rhinosinusitis [ ]. Three RCTs total of participants were included for analysis and various nasal symptom scores were assessed. Although significant improvements were observed in some symptom scores nasal secretion, nasal patency, and overall health status , these changes were relatively minor Table The authors concluded that the trials were too small and had too high a risk of trial bias to be confident that the benefits were meaningful.

Nevertheless, there was a trend toward reduced antibiotic use in one study as well as a significant reduction in time lost from work [ ]. Patient or population: patients with ABRS or common cold in adults and children. Intervention: nasal saline irrigation. Comparison: no irrigation. Both studies were designed to look at other endpoints, such as nasal saline vs hypertonic saline or medicated nose drops. Nasal saline vs no nasal saline comparison was obtained by comparing the saline intervention to the control group in each study.

It is not clear how many patients had ABRS; many if not most appear to have had simply a upper respiratory infection. The value of intranasal saline irrigation in young children is less certain. In a small clinical trial, 69 children with acute sinusitis mean age, 6 years [range, 3—12] were randomized to receive either saline irrigation or no irrigation [ ]. More important, the nasal peak expiratory flow rate was significantly improved in the saline irrigation group compared with no irrigation.

However, it is unclear how well the saline irrigation procedure was tolerated particularly among the younger children. Minor discomfort is common during saline irrigation, and installation of nasal drops is less well tolerated by babies, often making them cry and undoing any potential benefit of symptom relief. Several other studies evaluated the role of hypertonic vs physiologic saline on nasal airway patency and mucociliary clearance in patients with symptomatic rhinosinusitis [ , ]. Both saline preparations significantly improved mucociliary clearance compared with pretreatment values; however, only physiologic saline significantly improved nasal airway patency [ ].

In other studies, hypertonic saline was found to significantly improve nasal symptoms as well as global quality of life [ , ]. Finally, hypertonic saline caused increased nasal burning or irritation. The mechanism by which physiologic or hypertonic saline irrigation improves sinus-specific symptoms is unclear. It has been postulated that saline irrigation improves nasal symptoms by enhancing mucociliary function, decreasing mucosal edema, mechanically clearing inspissated mucus, and decreasing inflammatory mediators [ ].

Intranasal saline irrigation may relieve symptoms in both children and adults, and improve disease-specific quality of life. The recommendation in favor of saline irrigation places a relatively high value on potential benefits of increased comfort and safety of the saline irrigations, and relatively low value on local adverse effects such as irritation and a burning sensation. In addition, saline irrigants should be prepared from sterile or bottled water in light of recent reports of primary amebic encephalitis from contaminated tapwater used for saline nasal irrigation [ , ].

Nasal saline irrigation is less well tolerated in babies and young children and may make them cry, undoing any potential benefit. Given the small but consistent effect on symptoms and quality of life and relatively mild adverse effects, there is a net clinical benefit of intranasal physiologic or hypertonic saline irrigation as an adjunct to antimicrobial therapy in both adults and children with ABRS. The optimal concentration, volume, frequency, and most appropriate technique for nasal saline irrigation remain to be determined.

INCSs are recommended as an adjunct to antibiotics in the empiric treatment of ABRS, primarily in patients with a history of allergic rhinitis weak, moderate. INCSs offer modest symptomatic improvement and minimal adverse events with short-term use. Five trials [ 48 , — ] and a Cochrane review [ ] have documented modest symptomatic improvement with INCSs compared with a placebo, although the relative risk of improvement was only marginal statistically Table No difference was noted in complications or relapse rate in the 2 studies that recorded these secondary outcomes.

This suggests that the beneficial effect of INCSs, although consistently demonstrated in several studies, was relatively small. The beneficial effect of INCSs could be attributed to their anti-inflammatory properties, which may reduce mucosal swelling and promote drainage. Patient or population: patients with adults and children with ABRS. Setting: outpatient clinic.

Intervention: intranasal corticosteroids. Comparison: placebo. Symptom duration was relatively short at enrollment median, 7 days [range, 4—14 days]. No significant difference in clinical response rates was observed between the treatment groups OR, 0. However, the duration of symptoms in these patients was relatively short prior to enrollment median, 7 days [range, 4—14 days] , raising the possibility that at least some of the patients did not have bacterial infection. The recommendation supporting the use of INCSs as adjunctive therapy places a relatively high value on a small additional relief of symptoms, and a relatively low value on avoiding increased resource expenditure.

INCSs provide symptomatic relief and anti-inflammatory effects in the nasal mucosa, which theoretically decrease mucosal inflammation of the osteomeatal complex and allow the sinuses to drain. Short-term risks of INCSs are minimal but may include susceptibility to oral candidiasis. Use of any intranasal medications in children may not be well tolerated. However, in patients with concurrent allergic rhinitis, INCS should be routinely administered. Further studies in larger populations with these agents are clearly needed. Although decongestants and antihistamines are frequently prescribed in patients with ABRS, there is scant evidence to support that they hasten recovery. Although patients may subjectively feel improvement in nasal airway patency, objective rhinometric findings do not support this impression [ ].

There have been several RCTs that assessed the possibility of an additive effect of topical or oral decongestants or antihistamines to antimicrobial therapy in adults with ABRS [ , , ]. All patients received mg amoxicillin-clavulanate 3 times daily for 3 weeks. At 3 weeks, significant improvement from basal levels was observed in all treatment groups as well as the group that received no topical treatment; and there was no significant difference in improvement among these groups, Wiklund et al [ ] used plain sinus radiography to evaluate the effect of topical oxymetazoline vs placebo, each in combination with oral penicillin in patients with acute maxillary sinusitis.

Neither subjective symptom scores nor radiographic findings were significantly different in the treatment groups. On the contrary, topical treatment with decongestants may itself induce inflammation in the nasal cavity. Bende et al [ ] confirmed this experimentally in rabbits with acute bacterial sinusitis. Topical oxymetazoline was instilled in one nasal cavity and placebo in the other. After 48 hours, histological sections of the maxillary sinus mucosa revealed significantly more inflammatory changes in the oxymetazoline-treated side than in the placebo-treated side.

McCormick et al [ ] evaluated the efficacy of oral antihistamines brompheniramine and phenylpropanolamine in syrup in combination with nasal oxymetazoline vs placebo oral syrup and nasal saline in the treatment of ABRS in children. All patients received 14 days of oral amoxicillin. The addition of decongestant-antihistamine did not provide added benefit compared with amoxicillin alone in this study.

The antihistamine H1 antagonist loratadine does not possess any anticholinergic effects and is nonsedative. Its adjunctive effect to standard treatment with antibiotics and oral steroids was examined in a double-blind, placebo-controlled RCT in adults with acute rhinosinusitis associated with a strong history of allergy [ ]. All patients received amoxicillin-clavulanate 2 g daily for 14 days and oral prednisone.

Loratadine 10 mg daily or placebo was administered for 28 days. Nasal symptom scores based on self-reporting as well as a rhinologic examination at baseline and 4 weeks were significantly improved in the loratadine compared with the placebo group at the end of 2 and 4 weeks. In particular, the degree of improvement was significantly greater for certain symptoms including sneezing and nasal obstruction. However, this patient population is unique in that all had acute exacerbation of allergic rhinosinusitis, and these findings do not apply to the typical patient with ABRS. Furthermore, it is unclear whether INCSs rather than oral steroids would have been more efficacious and thus minimizes the adjunctive effect of loratadine. The recommendation against the use of decongestants or antihistamines as adjunctive therapy in ABRS places a relatively high value on avoiding adverse effects from these agents and a relatively low value on the incremental improvement of symptoms.

These agents may still provide symptom relief in some patients with acute viral rhinosinusitis when antimicrobial therapy is not indicated. Topical and oral decongestants may provide a subjective impression of improving nasal airway patency. Topical decongestants may induce rebound congestion and inflammation, and oral antihistamines may induce drowsiness, xerostomia, and other adverse effects.

Topical and oral decongestants and antihistamines should be avoided in patients with ABRS. Instead, symptomatic management should focus on hydration, analgesics, antipyretics, saline irrigation, and INCSs. An alternative management strategy is recommended if symptoms worsen after 48—72 hours of initial empiric antimicrobial therapy, or fail to improve despite 3—5 days of initial empiric antimicrobial therapy strong, moderate. In general, patients with ABRS should begin to respond clinically by 3—5 days following initiation of effective antimicrobial therapy [ 61 ]. Bacteriological eradication studies also indicate that most causative organisms are eliminated from the maxillary sinuses by 3 days following appropriate antimicrobial therapy.

Ambrose and his colleagues [ , , ] devised an innovative technique to determine the time course for bacteriological eradication and pharmacodynamic endpoints in the antimicrobial treatment of ABRS, by inserting an indwelling catheter into the maxillary sinus. This allowed serial sinus aspirate sampling for Gram stain, culture, and drug level measurements. Patients were treated with either gatifloxacin or levofloxacin. Among 8 patients with positive cultures 5 with S.

Similarly, Ariza et al [ ] obtained cultures of the middle meatus by endoscopy from 42 patients who were receiving treatment with moxifloxacin for microbiologically documented ABRS. Figure 4 shows a Kaplan-Meier plot of the proportion of patients with positive cultures for S. Interestingly, the time to bacterial eradication was longest for S. In the studies by Ambrose et al [ ], excellent correlation between time to bacterial eradication and time to clinical resolution was observed.

Thus, a bacteriologic as well as clinical response may be expected within 3—5 days in most patients receiving appropriate antimicrobial therapy. If symptoms and signs worsen despite 72 hours of initial empiric antimicrobial therapy, the possible reasons for treatment failure must be considered, including resistant pathogens, structural abnormalities, or a nonbacterial cause. Similarly, if there is no clinical improvement within 3—5 days despite empiric antimicrobial therapy, an alternate management strategy should be considered even though there is no clinical worsening. It should be noted that elderly patients and those with comorbid diseases may require longer time for clinical improvement.

Lindbaek [ ] conducted a prospective evaluation of factors present at the onset of acute sinusitis that might predict the total duration of illness among adults receiving antimicrobial therapy. As might be expected, age of the patient and the clinical severity of sinusitis at the onset of treatment were independent predictors of illness duration. However, even among elderly and severely ill patients, some improvement should be clinically evident after 3—5 days of appropriate antimicrobial therapy.

Careful clinical evaluation of the patient at 3—5 days is critical to assess the response to empiric antimicrobial therapy and to consider alternative management options if treatment failure is suspected. Premature discontinuation of first-line antimicrobial therapy in favor of second-line agents with broader antimicrobial coverage may promote overuse of antibiotics and increase costs as well as adverse effects. Little information is currently available on bacterial eradication rates in ABRS by antimicrobial classes other than the respiratory fluoroquinolones. Treatment failure should be considered in all patients who fail to improve at 3—5 days after initiation of antimicrobial therapy. In the final analysis, clinical judgment and close monitoring of the patient are critical in determining whether there is treatment failure or simply a slow clinical response.

More studies are needed to examine the bacterial eradication rates associated with different antimicrobial classes by sequential cultures of the middle meatus and correlate them with the clinical response. Patients with presumed ABRS who fail to respond to initial empiric antimicrobial treatment should be investigated for possible causes of failure, including infection with resistant pathogens, inadequate dosing, and noninfectious causes including allergy and structural abnormalities. There are few RCTs in which the microbiological diagnosis of ABRS is confirmed by sinus puncture at the time of clinical failure or follow-up. A review of available placebo-controlled trials almost all involving patients with a clinical diagnosis found only 1 study that provided data on the effect of a specific antimicrobial agent to treat clinical failures [ 61 ].

In this study, 4 children randomized to high-dose amoxicillin-clavulanate and 19 randomized to placebo who experienced treatment failure were provided cefpodoxime. All experienced successful outcomes following treatment with cefpodoxime for 10 days, although the reason for treatment failure with the study antibiotics was unclear, as sinus puncture was not performed in these patients.

Brook et al [ 96 ] performed consecutive cultures from maxillary sinus aspirates of 20 children with ABRS who failed initial empiric antimicrobial therapy. Thus, both inadequate dosing and bacterial resistance should be considered in all patients who fail to respond to initial empiric antimicrobial therapy. In choosing a second-line regimen in a patient who has failed initial antimicrobial therapy, an agent with broader spectrum of activity and in a different antimicrobial class should be considered [ 82 , ]. Antimicrobials selected should be active against PNS S. The recommended list of second-line antimicrobial agents suitable for children and for adults who experience treatment failure to first-line agents is shown in Tables 9 and 10 , respectively.

If symptoms persist or worsen despite 72 hours of treatment with a second-line regimen, referral to an otolaryngologist, allergist, or infectious disease specialist should be considered. Additional investigations such as sinus puncture or acquisition of cultures of the middle meatus, and CT or MRI studies should be initiated. Provide a systematic and algorithm-based approach to antimicrobial therapy of patients failing initial therapy. RCTs are needed to evaluate and optimize clinical approaches to the management of patients who fail to respond to initial empiric antimicrobial therapy, and to systematically assess all causes of clinical treatment failure. It is recommended that cultures be obtained by direct sinus aspiration rather than by nasopharyngeal swabs in patients with suspected sinus infection who have failed to respond to empiric antimicrobial therapy strong, moderate.

Endoscopically guided cultures of the middle meatus may be considered as an alternative in adults but their reliability in children has not been established weak, moderate. Benninger et al [ 31 ] reviewed the data from 5 studies correlating the microbiology obtained from nasopharyngeal swabs with cultures of sinus aspirates both in healthy adults and patients with acute maxillary sinusitis. When the maxillary sinus aspirate culture yielded a presumed sinus pathogen ie, S. Overall, nasopharyngeal cultures were considered unreliable for establishing the microbiologic diagnosis of ABRS. In contrast to nasopharyngeal swabs, endoscopically directed cultures of the middle meatus correlated better with cultures from direct sinus puncture. Benninger et al [ ] performed a meta-analysis involving adult patients from 3 published studies and additional unpublished data.

The correlation between endoscopically directed cultures of the middle meatus and sinus puncture in pediatric patients with ABRS has not been established. However, even in children without respiratory symptoms, cultures of the middle meatus often show S. Sinus culture provides the most accurate information compared with nasopharyngeal swabs or cultures of the middle meatus obtained endoscopically; however, cultures of the middle meatus are easier to obtain and less invasive and hence better tolerated by patients.

Sinus culture is invasive, time consuming, and not well tolerated by patients. Middle meatus cultures may not correlate with an infection of the sphenoidal sinuses but still would be expected to correlate with infection of the ethmoid or frontal sinuses because the latter primarily drain through the middle meatus. In contrast, a maxillary sinus tap would not be expected to identify pathogens from the ethmoid, frontal, or sphenoidal sinuses. More data are needed to validate the use of cultures of the middle meatus for assessing microbiological eradication rates and efficacy of antimicrobial therapy. In patients with ABRS suspected to have suppurative complications, obtaining axial and coronal views of contrast-enhanced CT rather than MRI is recommended for localization of infection and to guide further treatment weak, low.

Most cases of ABRS do not require radiographic evaluation because findings on plain radiographs or CT are nonspecific and do not distinguish bacterial from viral infection. The usefulness of imaging is in determining disease location and the extent of involvement beyond the original source. Occasionally, imaging studies may be useful to support the diagnosis or provide evidence of the degree of mucosal involvement, potentially guiding a more aggressive approach to therapy [ 23 ]. In general, more advanced imaging modalities such as CT or MRI should be reserved for recurrent or complicated cases or when suppurative complications are suspected. Suppurative complications of ABRS are rare, estimated to be 3.

Only approximately 1 of 95 hospital admissions in the United States is due to sinusitis-associated brain abscess [ ]. Overall, the evidence supporting a superiority of CT vs MRI for the diagnosis of suppurative complications of ABRS is very poor, consisting primarily of case reports and small retrospective observational studies. In general, CT is considered the gold standard for assessing bony and anatomical changes associated with acute or chronic sinusitis, whereas MRI is useful to further delineate the extent of soft tissue abnormalities and inflammation [ — ]. CT is also necessary for surgical planning and for intraoperative image-guided surgical navigation.

Younis et al [ ] evaluated the diagnostic accuracy of clinical assessment vs CT or MRI in the diagnosis of orbital and intracranial complications arising from sinusitis and confirmed by intraoperative findings. A total of 82 adults and children were studied retrospectively from a single medical center during — Thus, MRI appears more sensitive than CT for detecting soft tissue involvement in patients with suspected intracranial complications and is not associated with ionizing radiation [ , ]. In a retrospective descriptive study of 12 children with sinogenic intracranial empyema SIE , Adame et al [ ] reported that the diagnosis was missed in 4 patients who underwent nonenhanced CT. Axial imaging alone was unable to demonstrate SIE in 1 child with sphenoidal and ethmoid sinusitis, and coronal images were needed to demonstrate its presence and extent.

Thus, the recommendation of the IDSA panel in favor of contrast-enhanced CT over MRI places greater value on relative availability and speed of diagnosis by CT, and a lack of need for sedation, which is frequently required for MRI studies in infants and children. There are definite risks associated with these procedures. CT scanning results in low levels of radiation exposure, which may lead to radiation-induced illnesses if multiple scans are obtained [ ]. With either CT or MRI, there is a potential risk of allergic reactions to the contrast material, and appropriate precaution should be undertaken in patients with renal impairment. Because most of our knowledge in this area is based on retrospective case series or reports, the overall quality of evidence is weak.

As technology continues to evolve, more studies are needed to clarify the indications of these imaging techniques in the management of ABRS. Patients who are seriously ill, immunocompromised, continue to deteriorate clinically despite extended courses of antimicrobial therapy, or have recurrent bouts of acute rhinosinusitis with clearing between episodes should be referred to a specialist such as an otolaryngologist, infectious disease specialist, or allergist for consultation. Most patients with ABRS will respond to empiric antimicrobial therapy, usually within 3—5 days after initiation of treatment. However, when such patients fail to respond despite a change in antimicrobial therapy to broaden coverage for presumed bacterial resistance, prompt referral to a specialist such as an otolaryngologist, allergist, or infectious disease specialist should be considered.

A confirmation of diagnosis is probably best determined by an otolaryngologist, who may assist in obtaining cultures by sinus puncture or middle meatus endoscopy. Severe infection, particularly in the immunocompromised host, or patients with multiple medical problems that may complicate appropriate dosing or predispose to unusual microorganisms, should be referred to an infectious disease specialist. Patients with recurrent infection or suspected to have an underlying hypersensitivity or immunologic disorder should be referred to an allergist.

Patients with rapid deterioration and manifestations suggestive of orbital or intracranial suppurative complications require urgent consultation and a multidisciplinary approach. Prompt and appropriate referral should hasten the recovery in patients with complicated ABRS. Delay in appropriate referral to specialists may prolong illness, result in chronic disease, and occasionally lead to catastrophic consequences if life-threatening complications are not recognized. Unnecessary referral adds to the burden of healthcare costs. Early access to critical diagnostic facilities such as imaging studies, endoscopy, surgical biopsies, and immunologic testing is needed to improve healthcare and prevent the development of chronic sequelae.

Examples of suitable performance measures include:. Percentage of patients treated for sinusitis who met the criteria for therapy based on question I. Percentage of patients treated for sinusitis for which the appropriate antimicrobial is used as listed in Tables 9 and Percentage of patients treated for recommended duration of therapy based on question X. Percentage of patients who fail initial therapy and have an appropriate culture obtained based on question XVI.

Barlam as liaison of the IDSA Standards and Practice Guidelines Committee; Jennifer Padberg for overall guidance and coordination; and Vita Washington and Genet Demisashi for their capable assistance in all aspects of the development of this guideline.

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