Учебники / Revision Sinus Surgery Kountakis 2008

Method of Delivery of Home-Infused Intravenous Antibiotics

Several delivery methods exist for intravenous therapy for CRS. Inpatient, hospital-based treatment, with the use of traditional peripheral intravenous catheters, is significantly limited by the associated health-care cost, negative impact on daily function, and potential for nosocomial complications. Outpatient, home-based therapy, allows for more normal daily patient functioning and avoids the need for prolonged hospitalization. Multiple methods of delivery are available for home therapy. The least invasive and most frequently used is a PICC. The initial placement may be performed by a variety of health-care practitioners, including interventional radiology or dedicated nursing. Insertion of PICC lines has been shown to be highly successful, in one study greater than 96% of patients had a PICC successfully placed; however, 14.6% required a cut-down for successful placement [15]. The line is typically positioned near the antecubital fossa in the upper arm. The position of the distal end of the catheter near the superior vena cava is confirmed with radiographic imaging. In the majority of patients, the line is expected to function without issues and minimal impact on function for the entire duration of therapy, usually 6–8 weeks.

For patients requiring therapy for a greater period of time, such as patients receiving chemotherapy, central venous catheters (CVC) are placed for home therapy. These include such devices as Hickman catheters and portacaths. Care usually requires dressing changes around the insertion site several times a week for both PICC and Hickman catheters, and instruction on attaching the antibiotic up to the intravenous line. This usually requires a visiting nurse in the beginning and occasionally for the entire duration of treatment. Based on evidence from multiple series [2,8,13,18], the majority of patients are able to successfully complete a complete course of outpatient intravenous antibiotic therapy. However, given the potential for significant complications, we recommend a dedicated protocol as outlined below.

Complications of Intravenous Antibiotics

■The potential for both minor and major complications from long-term intravenous antibiotic therapy for sinusitis has been described.

■Most complications appear related to the antibiotic and not the intravenous line.

In the literature, there has been conflicting data regarding the incidence of PICC line complications. This may be

due, in part, to the numerous indications for insertion. In addition to antibiotic therapy, PICC lines are often used for home medications including chemotherapy and intravenous hydration or nutrition. Most studies examining PICC lines for long-term antibiotics have reported low complication rates related to the catheter itself, as low as 2% in one study of 177 patients [13]. These complications included line thrombosis and septicemia [13].

Complications can be divided into those related to the catheter, such as catheter failure, thrombosis, or infection, and those related to antibiotic therapy, including allergic reaction, gastrointestinal upset, or rash/flushing. The latter is well documented with the use of vancomycin, and is termed “red-man syndrome.” This reaction involves a pruritic and erythematous rash that occurs after infusion of vancomycin (Fig. 35.4). The spectrum of antibiotic-re- lated complications include: neutropenia, elevated liver function tests, allergic reaction, itching, and gastrointestinal upset, and may occur in up to 16% of patients [13]. However, most of these complications are considered minor, as only 9 of the 29 patients with an antibiotic-related complication in a study by Lin et al. required a change in antibiotic [13]. Most reactions are self-limiting and resolve once the antibiotic is switched or stopped. Other studies have seen much lower antibiotic complication rates, only 11 per 10,000 catheter days [15].

One study compared the delivery method of intravenous therapy by comparing PICC to CVC. In this study, PICC lines were found to have a higher complication rate

Fig. 35.4  “Red-man syndrome” seen with vancomycin infusion

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then CVC. Looking at the specific complications, PICC lines were associated with a statistically significant increase in the incidence of catheter malfunction, thrombophlebitis, and overall complications [16]. Furthermore, the average time period for development of a complication with a PICC was 20 days compared to 281 days for a CVC [16]. Looking specifically at PICC placed for antibiotic therapy, however, no significant difference in complications were noted when compared to CVC [16]. This is more consistent with another study on safety that found 11% complications in CVC compared to only 9% in PICC [9].

Despite the overall safety of outpatient intravenous antibiotic therapy, the potential for major complications do exist. Although complications such as catheter malfunc-

35 tion, thrombophlebitis, and rash may be easily managed, other potential complications are associated with significant morbidity, including neutropenia and anaphylaxis. Additionally, the occurrence of a complication may result in a break or possibly premature termination of therapy, limiting the treatment efficacy. In light of these issues, we recommend a dedicated protocol for patients receiving therapy, with the goals of minimizing the incidence and morbidity of any complications.

■Standard treatment protocol:

1.Initial consultation with an otolaryngologist and infectious disease specialist.

2.First antibiotic dose given in the physician’s office.

3.Dedicated visiting nursing at regular intervals.

4.Weekly office visits.

5.Regularly scheduled serologic testing.

6.Repeat endoscopic cultures.

The treatment plan involves initial consultation with both our team and an infectious disease specialist. The patient is counseled regarding the indications, potential benefits, and expected treatment course prior to therapy. Patients are also educated regarding the potential complications of therapy and instructed to contact the team with any concerning issues. The first dose is given in the office to monitor the patient for potential adverse events. The supervision of the first dose by the medical team in the office also increases the patient’s emotional comfort with the therapy prior to beginning home infusions. Dedicated visiting nurse services are scheduled during the initial infusions until the patient can reliably demonstrate competence with PICC care and antibiotic infusion. Following this, weekly office visits and home nursing visits are scheduled. Patients are also regularly scheduled for serologic testing of antibiotic levels, when indicated, as well as routine hematological and biochemical testing (given the potential for neutropenia), elevated liver function tests, and renal impairment. The patients are also followed for clinical and endoscopic response

Seth M. Brown, Abtin Tabaee, and Vijay K. Anand

throughout the course of therapy. Patients also undergo repeat surveillance sinonasal cultures if there is a history of resistant organisms.

Benefits of Intravenous Antibiotics

■The quality of life associated with home-based intravenous therapy is much higher than with hospital-based treatment.

■The insertion of peripherally inserted catheters, unlike most central catheters, does not require a surgical procedure and is generally well tolerated.

Home-based intravenous therapy requires a dedicated protocol of medical care and the commitment of the patient and family. Although visiting nurse care is often provided initially, the patient is taught how to properly attach the antibiotics and care for the catheter in a sterile fashion. Also, supplies and equipment must be available in the home and the patient’s schedule needs to be designed for regular medication delivery. Despite these challenges, the satisfaction and quality of life with home-based intravenous therapy is significant. In one study looking at quality of life on the Short Form-36, significant improvements were found in physical functioning, bodily pain, and emotional/ mental component summary scale scores, in comparing patients on home-based therapy compared to hospital-based treatment [6].

In analyzing direct costs, home-based intravenous therapy appears cost effective compared to hospital treatment. A fivefold decrease in cost is associated with PICC line insertion when compared to CVC [16]. One study estimated a potential saving of approximately $50,000 (US) per patient by using home-based intravenous antibiotic therapy compared to conventional hospital-based treatment [3]. With the rapidly increasing national health care expenditure, the trend toward cost-effective therapy, such as home care, will likely increase over time.

Conclusion

When appropriately indicated, intravenous antibiotic therapy may be beneficial to selected patients with refractory rhinosinusitis.

Tips and Pearls

1.Antibiotics should be considered in those patients with intracranial and intraorbital complications of sinusitis, CRS due to resistant organisms, and refractory CRS following maximal medical and surgical therapy.

2.The presence of hyperostosis on CT scan in patients with refractory CRS may indicate the potential role of intravenous antibiotic therapy.

3.Routine diagnostic and surveillance sinonasal cultures are recommended; choice of medications is largely based on culture and sensitivity information.

4.Pediatric patients may be good candidates for intravenous antibiotics, either as a surgical adjunct or alternative to surgery.

5.PICC lines are well tolerated and less expensive than centrally placed catheters or hospitalized treatment.

6.The majority of complications associated with PICC lines and home-based intravenous antibiotics are minor and easily managed; however, the potential for serious complications does exist.

7.A dedicated protocol is required to manage potential complications and minimize disruption of treatment.

8.The indications for intravenous antibiotic therapy in CRS may be increasing given the rising incidence of resistant organisms and possible role of hyperostosis in refractory sinus disease.

References

1.Anand VK (2004) Epidemiology and economic impact of rhinosinusitis. Ann Otol Rhinol Laryngol 113:3–5

2.Anand V, Levine H, Friedman M, et al. (2003) Intravenous antibiotics for refractory rhinosinusitis in nonsurgical patients: preliminary findings of a prospective study. Am J Rhinol 17:363–368

3.Bernard L, El-hajj, Pron B, et al. (2001) Outpatient parenteral antimicrobial therapy (OPAT) for the treatment of osteomyelitis: evaluation of efficacy, tolerance and cost. J Clin Pharm Ther 26:445–451

4.Don DM, Yellow RF, Casselbrant ML, et al. (2001) Efficacy of a stepwise protocol that includes intravenous antibiotic therapy for the management of chronic sinusitis in children and adolescents. Arch Otolaryngol Head Neck Surg 127:1093–1098

5.Fowler KC, Duncavage JA, Murray JJ, et al. (2003) Chronic sinusitis and intravenous antibiotic therapy: resolution, recurrent and adverse events. J Allergy Clin Immunol 111: s85

6.Goodfellow AF, Wai AO, Frighetto L, et al. (2002) Qual- ity-of-life assessment in an outpatient parental antibiotic program. Ann Pharmacother 36:1851–1855

7.Gomez M, Maraqa N, Alvarez A, et al. (2001) Complications of outpatient parenteral antibiotic therapy in childhood. Pediatr Infect Dis J 20:541–543

8.Gross ND, McInnes RJ, Hwang PH (2002) Outpatient intravenous antibiotics for chronic rhinosinusitis. Laryngoscope 112:1758–1761

9.Hoffman-Terry ML, Fraimow HS, Fox TR, et al. (1999) Adverse effects of outpatient parenteral antibiotic therapy. Am J Med 106:44–49

10.Huang WH, Hung PK (2006) Methicillin-resistant Staphylococcus aureus infections in acute rhinosinusitis. Laryngoscope 116:288–291

11.Jiang RS, Jang JW, Hsu CY (1999) Post-functional endoscopic sinus surgery methicillin-resistant Staphylococcus aureus sinusitis. Am J Rhinol 13:273–277

12.Kacker A, Huang C, Anand V (2002) Incidence of chronic hyperostotic rhinosinusitis in patients undergoing primary sinus surgery compared to revision surgery. Rhinol 40:80–82

13.Lin JW, Kacker A, Anand VK, et al. (2005) Catheterand antibiotic-related complications of ambulatory intravenous antibiotic therapy for chronic rhinosinusitis. Am J Rhinol 19:365–369

14.Manarey CR, Anand VK, Huang C (2004) Incidence of methicillin-resistant Staphylococcus aureus causing chronic rhinosinusitis. Laryngoscope 114:939–941

15.Ng PK, Ault MJ, Ellrodt AG, et al. (1997) Peripherally inserted central catheters in general medicine. Mayo Clin Proc 72:225–233

16.Smith JR, Friedell ML, Cheatham ML, et al. (1998) Peripherally inserted central catheters revisited. Am J Surg 176:208–211

17.Solares CA, Batra PS, Hall GS, et al. (2006) Treatment of chronic rhinosinusitis exacerbations due to methicillin-re- sistant Staphylococcus aureus with mupirocin irrigations. Am J Otolaryngol 27:161–165

18.Tabaee A, Anand VK, Yoon C (2007) Outpatient intravenous antibiotics for methicillin-resistant Staphylococcus aureus sinusitis. Am J Rhinol 21:154–158

 Core Messages

■Assessment of outcome in revision sinus surgery is multifactorial.

■There are several ways to assess both objective and subjective outcomes.

■In revision surgery, and in chronic disease, the definition of a “successful” outcome likely differs from that of success after an acute or resolving process.

■Existing tools developed for chronic rhinosinusitis should be adequate for use in revision surgery.

Introduction

Assessment of outcome after any type of sinus surgery has not been uniformly defined or standardized, and assessment is likely multifactorial. Objective outcomes, such as endoscopic examination findings, computed tomography (CT) scan findings, need for medical treatment, or surgical revision rate, are important to assess. Subjective outcomes, such as symptoms and quality of life (QOL), are also important. Furthermore, there is good evidence that the objective and subjective data in chronic rhinosinusitis do not always correlate well. Therefore, the assessment of both outcomes is important. After sinus surgery – and particularly revision sinus surgery – these issues are particularly salient, since the anatomy is invariably altered and may remain “abnormal” even with complete resolution of symptoms.

■In addition to discussing how to assess outcome, we should consider when to assess outcome. In certain diseases (for example, cancer), long-term outcomes are invariably preferred over short-term outcomes. In other chronic diseases, improvement in short-term status can be quite beneficial and should be recommended, even if long-term outcomes are predictably

poor. This may be of particular importance in revision surgery for problems such as nasal polyposis

Outcomes Assessment in Rhinosinusitis

Much work has gone into classification and outcomes assessment in chronic rhinosinusitis, and this will be reviewed later in the chapter. However, there is a lack of material specifically focusing on revision surgery. Despite the fact that there are some potential challenges, there is no reason that existing outcome tools cannot be used. Symptoms and QOL should still be important outcomes to assess, and are likely a major driver of patient behavior after surgery – similar to before surgery. In addition, the impact of sinusitis on the symptoms and severity of other diseases, such as asthma, is likely as important after revision surgery as any other time. Objective outcome assessment, in particular CT scan findings, might require a modified interpretation after revision surgery, however. There is limited data on CT mucosal changes that should be expected after surgical intervention. Landmarks have

symptoms listed, then each symptom counts for 1/10 (10%) of the total “symptom score.” Rhinologists would probably agree that purulent rhinorrhea, for example, is a more important and predictive symptom of sinusitis than, say, headache. If each were on the same list, however, then changes in each would be counted similarly. Some work is needed to define and validate a symptom tool for use as an outcome measure in rhinosinusitis [16, 21].

Despite the obvious importance of symptoms and subjective outcomes, there are problems with using them in isolation – a large problem being that some symptoms and QOL changes will be due to other diseases besides rhinosinusitis. Therefore, subjective outcomes are only part of the overall picture. A review of subjective outcomes instruments follows in a later section.

Objective Outcomes

■CT staging systems are classificatory systems and were designed to allow standardization, classification, and a common language (Fig. 36.1).

■CT staging systems were not designed to predict outcome.

■There is a high correlation between endoscopic stage and CT stage in patients with chronic rhinosinusitis.

■CT staging may be more appropriate than endoscopic staging for frontal sinus disease, due to the remote location of the frontal sinus.

There are several objective outcomes that can be assessed after sinus surgery and revision sinus surgery. CT scan

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findings are very important as an assessment of mucosal thickening, ostia obstruction, fluid level, and anatomic extent of disease, as well as demonstrating other important information such as bony dehiscence and presence of extrasinus extension of disease, for example. There are several staging systems that have been proposed for sinus CT scans; among the most popular are the LundMacKay, Kennedy, and Harvard systems [17]. These staging systems were designed to allow standardization, classification, and a common language – in other words they are classificatory systems. They were not designed to predict outcome (prognostic systems), although it is possible that they do so. Potential problems with any CT staging system include missing sinuses, the effect of previous surgical sinus dissection, and difficulty in differentiating mucosal thickening from retained secretions

36 [17]. In revision surgery, these issues can be particularly difficult because of the changed anatomy of the ostiomeatal complex. Despite these issues, however, the CT scan is easily available, gives useful anatomic information, and is a widely used technique for assessing the sinus mucosa and anatomy.

There is a staging system for endoscopic findings [17]. Since endoscopic examination and the CT scan are both used to assess anatomy and mucosal status, not surprisingly there is a high correlation between endoscopic stage and CT stage. This is likely particularly true after revision sinus surgery, where the ostia have been opened and tissue removed, making endoscopic evaluation of most of the sinuses even easier. However, even after successful surgery, there are some sinuses, in particular the frontal, which might be difficult to assess with endoscopy alone, and CT scans still play an important role.

Other objective outcomes of potential use in revision sinus surgery include culture results, olfactory testing, and the presence and severity of related diseases such as asthma. In addition, if one of the complaints is nasal obstruction, then acoustic rhinometry or rhinomanometry can yield objective data [18]. However, neither of those tests is widely accepted in clinical practice and there is debate about the techniques of testing and interpretation. Nevertheless, they do provide objective data on the anatomy of the nasal airway.

Bacteriology, and in particular the presence of resistant bacteria, or fungus, can be important outcomes in revision sinus surgery. However, many patients are on long-term antibiotics, making culture results possibly less reliable, and there is always the possibility of sampling error and differences in laboratory techniques when reviewing culture results. Olfactory testing is beyond the scope of this chapter, but there are reproducible tests of olfaction. One obvious caveat is that olfactory function may be impaired before treatment, or as a result of another disease.

Michael G. Stewart and Scott M. Rickert

Another potential “objective” outcome is the need for oral or topical medications, with the theory being that successful surgery might reduce the need for extensive medical treatment. However, use of that as an outcome may be problematic for a few reasons. The use of medications to control persistent disease or prevent recurrent disease may be desirable, and should not necessarily represent “failure.” In addition, medications are often taken for related problems (such as allergies or pulmonary disease). Finally, use of medication is volitional, and patients may use or not use them for different reasons, making medication frequency of use less “objective” than it might initially seem.

Association Between Objective

and Subjective Outcomes

■It is now well-established that symptoms and QOL do not correlate with CT scan findings in chronic rhinosinusitis [7, 8, 11, 14, 24, 27, 28].

■This does not mean that CT scan findings are not important, or that symptoms are not important, but it does mean that they are not measuring the same thing, and that you cannot predict one simply by knowing the other.

While it is clear that CT scan findings do not predict symptoms at any given point in time, there is conflicting evidence on whether or not CT findings might actually predict changes in symptoms or QOL after surgery or other treatment. One prospective study found that the CT scan stage was a significant independent predictor of improvement in symptoms after sinus surgery [26]. In that study, patients with higher-stage disease on CT (i.e., worse mucosal disease) had larger proportional improvements in disease-specific QOL after surgery. Another prospective study also found that CT stage approached significance as a predictor of outcome [25]. Other prospective studies however found that CT stage was not an independent predictor of change in disease-specific QOL or symptom severity after surgery [6, 8]. All studies have shown large overall improvements in disease-specific QOL after endoscopic sinus surgery.

In addition, one study has shown that objective findings may predict the need for revision sinus surgery [12]. Specifically, patients from a tertiary referral practice who eventually required revision endoscopic surgery were statistically more likely to have an abnormal endoscopic examination at 18 months after the initial surgery. Interestingly, in that series symptom severity at 18 months was not predictive of needing eventual surgical revision.

Available Validated Health Status Instruments for Use in Rhinosinusitis

Global QOL Instruments

There are hundreds of validated global QOL instruments, any of which could be potentially used as an outcome assessment in revision surgery. The Short Form 36-item Health Survey (SF-36) has been used in studies of chronic rhinosinusitis and the effect of sinus surgery, and it is clearly sensitive to the impact of chronic rhinosinusitis. The instrument comprises 36 questions that are scored into 8 general health domains, such as, for example, bodily pain, vitality, and social functioning. A shortened version, the SF-12, is also a global instrument, and it is scored into only two subscales – physical health component and mental health component. One desirable characteristic of the SF-36 and SF-12 are that they have both been used extensively, and there are good benchmark comparison data for healthy individuals and also multiple diseases.

Many other global QOL instruments can be used. However, when using any global instrument, it is possible that the scale will not be sensitive to the effects of a specific disease. So, lack of response on a global QOL instrument does not necessarily mean lack of effectiveness.

Disease-Specific Instruments

There are several validated disease-specific instruments for rhinosinusitis in adults, and in fact all have been used successfully in studies. Content, length, period of symptom recall, and scoring are different for each, so there are several potential options [21].

The Chronic Sinusitis Survey (CSS; Fig. 36.2) [10] was designed for chronic rhinosinusitis, contains six items, and was validated for a symptom recall period of 8 weeks. There are two subscales: medication and symptom. The CSS is very sensitive to change over time, although its limited content might exclude some aspects of sinusitis in some patients.

The Rhinosinusitis Outcome Measure (RSOM-31; Fig. 36.3) [22] was originally developed as a 31-question comprehensive assessment of sinusitis-specific symptoms with some general health assessment included. Since its initial inception, this particular instrument has been simplified and revalidated to be shorter and more sinusitisspecific. The current widely used version is the Sinonasal Outcome Test-20 items (SNOT-20; Fig. 36.4), which contains 20 items, with no designated period of symptom recall. The SNOT-20 is scored as a single scale.

The Rhinosinusitis Disability Index (RSDI; Fig. 36.5) [3] is a validated instrument with items written in the first

person, and it relates symptoms to limitations on daily life. It was designed for CRS, contains 30 items, and has no designated period of symptom recall. It is scored into three subscales: emotional, physical, and functional. The content of some of the items cover more global QOL issues than other disease-specific instruments.

The Rhinosinusitis Quality of Life Survey (RhinoQOL; Fig. 36.6) [2] is a validated instrument that was designed to be used for both acute and chronic rhinosinusitis. It contains 17 items and uses a recall period of 7 days. It is scored into three subscales: symptom frequency, symptom bother, and symptom effect. While the authors report that the instrument can be used in acute or chronic sinusitis, there is some potential concern that the content for those diseases will not be identical.

Results after Revision Endoscopic Sinus Surgery

Compared to the volume of literature on primary sinus surgery, there are fewer reports on outcomes after revision sinus surgery. Many of the published reports on revision surgery address indications and techniques, but not outcomes. Others report outcome only as success or failure rate, usually defined as the need for further revision surgery. As we have discussed earlier, this is probably not the ideal outcome to assess in this group of patients. We briefly describe the results from selected series below; this is not an exhaustive list.

One study of 125 patients over a 3-year period undergoing revision endoscopic sinus surgery reported both objective and subjective outcomes [19]. In that series, objective outcomes were CT scan findings, assessed using the Lund-MacKay system, and endoscopy score, assessed using a scoring system described by the 1997 Rhinosinusitis Task Force [17]. Subjective outcomes were SNOT-20 score, and individual symptoms measured on a visual analog scale. The mean number of prior surgical procedures was 1.9. The authors found significant and sustained improvements in both objective and subjective outcomes after revision surgery. In particular, mean SNOT-20 scores improved from 30.7 to 7.7 at 2 years of follow-up, and mean endoscopy scores improved from 7.3 to 2.1 at 2-years follow-up. Six individual symptoms were measured using Likert scales (nasal obstruction, congestion, rhinorrhea, postnasal drip, facial pain/pressure, olfactory dysfunction), and all six showed large-magnitude and statistically significant improvements at 2 years. Of the 125 patients, 59 had nasal polyposis; those 59 patients also had more prior surgeries, higher CT scores (worse disease), but lower (better) SNOT-20 scores. The authors did not report postoperative CT scores.

In another report from a subset (n = 80) of the same

Fig. 36.3  Rhinosinusitis outcome measure (RSOM-31)

patient population, patients for revision surgery who also had asthma had significantly worse CT scan findings than patients without asthma (mean Lund-MacKay scores of 18.6 vs. 11.7) [13]. However, disease-specific QOL before revision surgery was not significantly different (mean SNOT-20 scores of 49.6 vs. 44.9). Patients with and without asthma both had highly significant – but statistically indistinguishable – improvements in SNOT-20 score

(70% improvement vs. 72.6% improvement) compared to preoperative scores. Therefore, despite worse CT scan findings, patients with asthma had equivalent significant improvement in symptoms after revision surgery compared to patients without asthma.

Another prospective study on revision sinus surgery reported changes in symptoms using the Rhinosinusitis Symptom Inventory, which is a summation of individual