Failed shoulder arthroplasty - the role of pre-revision cultures.

 Role of Pre-Revision Tissue Biopsy In Evaluation of Painful Shoulder Arthroplasty: A Systematic Review & Meta-Analysis

Pre-revision tissue biopsy (PTB) for culture has been utilized as a diagnostic tool in the evaluation for periprosthetic joint infection (PJI) among patients with painful shoulder arthroplasty. 

These authors conducted a systematic review to determine the sensitivity (SN), specificity (SP), negative predictive value (NPV), and positive predictive value (PPV) of PTB culture results compared with culture at the time of subsequent revision surgery and  to report the current indications and protocols described for use of PTB.

Studies were included if an arthroscopic or open tissue biopsy was performed in patients who had previously undergone anatomic total shoulder arthroplasty, shoulder hemiarthroplasty, or reverse total shoulder arthroplasty as a separate procedure prior to revision of components, if applicable. 

The analysis was performed 

defining 1 positive PTB culture as “infection” and again 

defining 2 positive cultures as “infection.”

Four total studies encompassing 72 patients met inclusion criteria. All studies were small (N = 13-23), retrospective series, with all but 12 biopsies performed arthroscopically. Sixty-five patients (90.2%) underwent subsequent revision surgery and biopsy. 

Twenty-three of these patients (35.4%) had at least one positive culture with PTB and revision surgery biopsy. 

For 1 positive PTB, the SN of PTB was 92.0%, SP 70.0%, PPV 65.7%, and NPV 93.3%. 

For 2 positive PTB, the SN of PTB was 100%, SP 50.0%, PPV 33.3%, and NPV 100%.

 

The authors concluded that pre-revision tissue biopsy has high negative predictive value.

Comment: A few questions arise:

(1) What does it mean if the pre-revision tissue biopsy is positive and the revision biopsy culture is negative (as happened in 12 cases)? Where did the bugs go?

(2) Doesn't the chance of having 1 (or 2) positive cultures relate to the number of specimens sent to the lab? 

This review of four publications suggests that 

a negative pre revision tissue culture is rarely associated with positive intra-operative cultures, whereas a positive pre revision tissue culture may or may not be associated with positive intra-operative cultures.

Thus the surgeon may use a pre-revision tissue culture when she or he is considering leaving some or all of the implants in place. 

On the other hand, pre-revision tissue cultures may be of less value when prosthesis exchange is planned.

The questions to be answered are 

-to what degree might a pre-revision surgical biopsy procedure change what is done at revision for a failed shoulder arthroplasty? 

and

-is the cost and risk of the additional biopsy procedure offset by the value of the information gained?

We find that substantial information regarding the risk of a periprosthetic infection can be gained without an added surgical procedure, using such patient characteristics as

(1) younger age

(2) male sex

(3) supplemental testosterone

(4) a honeymoon period of good comfort and function after the arthroplasty before the otherwise unexplained onset of pain and or stiffness

(5) radiographic humeral component loosening.

Consistent with the results of this review, we find that a normal result of a fluid aspirate, CBC, sed rate, CRP, and intraoperative histology are not useful in ruling out a Cutibacterium periprosthetic infection.

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Revision arthroplasty - is there a reason to perform a pre-revision tissue biopsy useful to predict culture results at surgery?

Utility of prerevision tissue biopsy sample to predict revision shoulder arthroplasty culture results in at-risk patients.

These authors  evaluated the utility of a prerevision biopsy sample in predicting positive cultures or a final diagnosis of infection in the setting of an "at-risk" failed shoulder arthroplasty in 77 patients with no history of infection undergoing revision shoulder arthroplasty.

All patients with a painful arthroplasty underwent laboratory evaluation, including ESR and CRP, as well as a fluoroscopically guided intra-articular aspiration (cultures were held for 2 weeks). Patients were classified into 1 of 4 categories, and prerevision biopsy was performed according to the grouping: (1) gross purulence, drainage, fluctuance, a sinus tract or a positive aspirate (bacterial growth on culture), (2) ESR and CRP were normal and the aspiration had no growth, (3) results for ESR or the CRP, or both, were abnormal, with no growth on the aspiration, and (4) results for ESR and CRP were normal and no fluid was available on the aspirate.

Group 1 patients were considered infected; therefore, revision arthroplasty was performed consisting of explantation and placement of an antibiotic-impregnated cement hemiarthroplasty or a resection arthroplasty without performing a prerevision biopsy. Group 2 patients were considered at low risk for infection; therefore, revision arthroplasty was performed without performing a prerevision biopsy. Group 3 and 4 patients were considered “at-risk” for the presence of infection at definitive revision; therefore, pre revision open or arthroscopic biopsies were performed in these groups. This study evaluated the 17 patients treated in groups 3 and 4 that had a pre revision biopsy.

All cultures were assessed for aerobic and anaerobic bacteria held for 2 weeks with specific instructions to rule out P acnes. A minimum of 2 samples (3 samples for the final 15 patients) were taken for culture at the time of the biopsy and also at the time of revision arthroplasty.

2 out of 9 patients with positive biopsy cultures had negative cultures at revision.

3 out of 6 patients with negative biopsy cultures had positive cultures at revision.

The samples from 11 of 17 biopsy procedures were positive for at least 1 culture. Bacteria included
P acnes in 8, coagulase-negative Staphylococcus in 2, Streptococcus mitis in 1, diphtheroid in 1, and Brevibacterium casei in 1. Multiple bacteria grew in the samples from 2 patients.

At the time of revision, 12 of 17 patients had cultures return positive for at least 1 culture. Bacteria included P acnes in 7, coagulase-negative Staphylococcus 2, S lugdunensis in 1, and Enterococcus faecium in 1.

Two of 9 patients who had positive cultures from the biopsy and the revision had different bacteria on the revision culture compared with the biopsy! (see yesterday's post).

Comment: This paper provides some important insight into the difficult challenge of predicting the culture results at the time of revision surgery based on preoperative information. First of all it is of note that the authors did pretty well at predicting culture positivity at revision based on clinical criteria alone: 12 of the 17 patients that they determined were 'at risk' indeed had positive cultures at revision without submitting them to an additional surgical procedure.

Of particular interest is their Group 4 in which the results for ESR and CRP were normal and no fluid was available on the aspirate. 4 of the 7 shoulders were culture positive at revision even though there were no pre-revision abnormal labs. Only 2 of these 4 had positive biopsies.

What is missing from this report is the results of the cultures at revision surgery for Group 2: ESR and CRP were normal and the aspiration had no growth. There is substantial evidence that there is a very high rate of false negative joint fluid cultures in the presence of multiply positive tissue and explant cultures. We wonder what percent of these 'fluid no growth' cases had positive cultures at revision surgery.

In our practice we do not submit patients to an additional surgical procedure to obtain a biopsy before revision of a failed shoulder arthroplasty because, as this paper demonstrates, a negative biopsy does not exclude the possibility of positive cultures at the time of revision. This is because bacteria are not evenly distributed through a culture-positive shoulder. 

As an analogy, we could take a number of samples of this lawn and not find two that show a mushroom, but that doesn't mean mushrooms are not really there.

, 

The reader is directed to two recent related posts:

The challenge of diagnosing a propionibacterium "infection"

Periprosthetic shoulder infections with Propionibacterium - how many surgeries are needed?

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Shoulder arthroscopy after shoulder arthroplasty - considering infection with Propionibacterium

Indications and outcomes of shoulder arthroscopy after shoulder arthroplasty.

These authors reviewed 11 Level IV publications containing 84 patients on shoulder arthroscopy in patients after shoulder arthroplasty.

The most common indications for shoulder arthroscopy in the setting of shoulder arthroplasty were pain or loss of range of motion without a clear diagnosis, suspected periprosthetic infection, and rotator cuff assessment.

Of the 84 patients, 37 (44%) required further surgery after arthroscopy. Twenty-one patients (25%) underwent an open revision arthroplasty for a periprosthetic infection,. Four patients (6%) underwent a resultant revision shoulder arthroplasty for aseptic component loosening (4%), component wear (1%), or malposition (1%).

Comment:  While an arthroscopic 'tune up' of a prior arthroplasty that is painful or stiff sounds attractive, evidence in support of this approach is lacking. The principal value of post arthroplasty arthroscopy appears to be obtaining specimens for tissue culture to evaluate the possibility of periprosthetic shoulder infection. This has been discussed in a prior post that pointed out while  fluoroscopically guided glenohumeral aspiration is specific it is relatively insensitive to the presence of Propionibacterium.

Recognizing the prevalence of Propionibacterium in failed shoulder joint replacement, a reasonable approach to the painful arthroplasty without apparent cause may be:

(1) fluoroscopically guided glenohumeral aspiration with careful fluid culturing directed at identifying Propionibacterium

(2) if the aspirate is negative, proceed to arthroscopy with multiple tissue biopsies submitted for culture directed at identifying Propionibacterium

(3) if the arthroscopic cultures are negative, consider open revision with multiple tissue biopsies submitted for culture directed at identifying Propionibacterium and treating the patient with antibiotics until the results of the cultures are finalized.

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Periprosthetic shoulder infections with Propionibacterium - how many surgeries are needed?

Arthroscopic Tissue Culture for the Evaluation of Periprosthetic Shoulder Infection

The senior authors evaluated approximately 350 painful shoulder arthroplasties performed during the study time period. Of these, 19 patients had undergone culture of arthroscopic biopsy tissue during the evaluation of a possible chronic periprosthetic shoulder infection. None of the patients in the study population had concomitant elevation of the WBC, ESR, and CRP values. The mean age at the time of the index arthroplasty was 56.7 years, and the mean interval (and standard deviation) between the index arthroplasty and the arthroscopic biopsy was 3.0 ± 2.0 years (range, 0.7 to 7.7 years)

Of these 19, 10 had negative arthroscopic biopsy cultures and negative open biopsy cultures taken at the time of surgical revision.

For those shoulders with positive cultures, the mean time for the culture to turn positive was 10.1 ± 3.79 days (range, 5 to 18 days).

7 had positive arthroscopic biopsy cultures for Propionibacterium and positive cultures for this same organism at the time of surgical revision.

2 had positive arthroscopic biopsy cultures for Propionibacterium but no cultures were taken at the time of revision.

6 shoulder joint fluid aspirations were done on patients who were subsequently found to have positive biopsy cultures for Propionibacterium - only one of the aspirates was culture positive.

The authors performed complete removal of the prosthetic components and placement of a custom antibiotic spacer in eight of the nine patients with a positive arthroscopic tissue biopsy culture at a mean of 11.2 ± 8.9 weeks (range, 3.4 to 29.3 weeks). The ninth patient had a single stage revision without apparent recurrence of infection.

Comment: This is a retrospective study of a small percentage of the authors' patients having revision surgery. The authors state that "Arthroscopy was performed in patients for whom the diagnosis of periprosthetic infection could not be reasonably confirmed or refuted by the patient history, physical examination, imaging studies, and laboratory data." One would think that there would be more than 19 of the 350 painful arthroplasties that met these criteria. The case the authors show in figure one is a common scenario: A patient with two years of pain and stiffness after a left TSA. Laboratory results were normal, and there was no growth from a fluoroscopically guided glenohumeral aspiration. An anteroposterior radiograph showed notable radiolucency about the pegged glenoid component". As prior recent posts have pointed out, glenoid or humeral component loosening is strongly suggestive of the presence of Propionibacterium. Again, since glenoid component loosening is a primary cause of failure of total shoulder arthroplasty, one might expect more cases like that shown in figure 1 among the 350. 

It is of interest that the time between between the index arthroplasty and the diagnosis of positive cultures was long:  3.0 ± 2.0 years (range, 0.7 to 7.7 years). This is consistent with the results discussed in a prior post.

Perhaps a bigger question is the protocol to be used in evaluating shoulders for possible Propionibacterium and for treating shoulders with positive cultures. The protocol one might conclude from this paper is that, since as their data show, the presence of Propionibacterium is not at all excluded by the absence of clinical and laboratory evidence of infection, all revisions should be preceded by an arthroscopic biopsy under anesthesia. If the culture results are negative, then a single stage revision is performed. If the culture results are positive a two stage revision is performed. This means that revision of a failed shoulder arthroplasty would commonly require two or three surgical procedures. 

By contrast in our practice (as summarized here), we try to reduce the number of anesthetics to one by obtaining cultures at the time of the revision, performing a single stage prosthesis revision to an uncemented Vancomycin-impregnated impaction grafted hemiarthroplasty followed by systemic antibiotic treatment until the culture results are finalized (at which time the antibiotic program is modified by our infectious disease consultations). We have yet to find convincing data to support the routine use of cement spacers in the management of Propionibacterium-positive failed arthroplasties.

Finally, as shown in this paper, culture of needle aspirated joint fluid is helpful only if the culture is positive, but not it it's negative.

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Propionibacteriium and Staph infection in shoulder arthroplasty - not that easy to treat.

Management of deep postoperative shoulder infections: is there a role for open biopsy during staged treatment?

The authors'  current treatment algorithm for infected shoulder arthroplasty includes explant of the infected prostheses, followed by antibiotic cement spacer placement and at least a 6-week course of antibiotic therapy before reimplantation of a new prosthesis. Even with this vigorous treatment they note that reinfection rates of between 0% and 37% have been reported after a 2-stage revision.

They reviewed 18 patients having periprosthetic shoulder infections and osteomyelitis after previous surgery who were treated with a standardized protocol of irrigation and debridement, removal of implants, antibiotic cement spacer placement (1 gram vancomycin and 1.2 grams tobramycin for every bag of polymethyl methacrylate), and pathogen-directed antibiotic therapy for 6 weeks. Open biopsies were performed in the operating room after a 4-week antibiotic holiday period. Revision arthroplasty was performed at a later date if final cultures were without evidence of infection. If evidence of infection persisted, then another course of I&D and antibiotic treatment was performed.

Four patients (22%) had evidence of persistent infection on specimens from open biopsy and required another course of formal I&D, spacer exchange, and a 6-week course of antibiotic therapy. After a second course of therapy, specimens from repeat biopsies were sterile for 3 of these 4 patients, and their prosthesis was able to be replanted. One patient had positive cultures again at his third biopsy and required a third round of surgical and antibiotic therapy according to the protocol. Results from specimens from this patient’s third open biopsy were negative, and he was replanted with a RTSA.

At the first revision, the most common pathogens isolated were Propionibacterium acnes (44%), Staphylococcus epidermidis (39%), and S aureus (22%). The infecting pathogen in 75% of patients with persistent infection was P acnes, and 38% of patients with P acnes infection had recurrence. 

Mean follow-up of 24 months showed no signs of recurrent infection in any patient and an average American Shoulder and Elbow Surgeon score of 71.

Comment: 

These authors recognize that simple needle aspirates are insufficient for excluding infection: often the organisms reside in biofilms such that tissue biopsies are necessary to recover them.

Note that the patients in this case series had obvious periprosthetic infections with deep draining sinus, purulent drainage from the wound, erythema, abnormal white blood cell, C-reactive protein, erythrocyte sedimentation rate, computed tomography, magnetic resonance imaging, and

joint aspiration.

It is indeed impressive to note the persistence of positive cultures after such a vigorous initial course of surgical and medical treatment. 

While this is a labor intensive and expensive protocol, it is rewarding to see that all 18 of these patients were free of clinical signs of infection two years after their last revision procedure.

Finally, it is important to distinguish these cases of clinically apparent periprosthetic infection with the revision arthroplasty with positive cultures but without clinical signs of infection.

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Open biopsy in the management of shoulder infections

Management of deep postoperative shoulder infections: is there a role for open biopsy during staged treatment?

These authors assert that the gold standard treatment of infected shoulder arthroplastiess is a 2-stage exchange arthroplasty. They note that reinfection after periprosthetic shoulder infections and periarticular osteomyelitis are reported to be as high as 37%.

They present a report of 18 patients who presented with periprosthetic shoulder infections and osteomyelitis after previous surgery. The deep infection was diagnosed by a combination of clinical signs and various diagnostic methods, including deep draining sinus, purulent drainage from the wound, erythema, abnormal white blood cell, C-reactive protein, erythrocyte sedimentation rate, computed tomography, magnetic resonance imaging, and joint aspiration.

Treatment included irrigation and debridement, removal of implants, antibiotic cement spacer placement, and pathogen-directed antibiotic therapy for 6 weeks. These authors used polymethyl  methacrylate spacers with 1 gram vancomycin and 1.2 grams tobramycin per bag of PMMA. After completion of antibiotics and resolution of clinical symptoms, specimens were obtained from an open biopsy performed in the operating room, followed by revision arthroplasty at a later date if final cultures were without evidence of infection. If evidence of infection persisted, then another course of I&D and antibiotic treatment was performed. 

The most common pathogens isolated were Propionibacterium acnes (44%), Staphylococcus epidermidis (39%), and S aureus (22%). Four patients (22%) had evidence of persistent infection on specimens from open biopsy and required subsequent rounds of I&D before replantation. The infecting pathogen in 75% of patients with persistent infection was P acnes, and 38% of patients with P acnes infection had recurrence.

Comment: This study underlines the fact that Propionibacterium can be a resistant pathogen in shoulder arthroplasty infections. 

The cases reported here are to be distinguished from those revisions for pain, stiffness or loosening in which there was no obvious clinical evidence of infection before or at surgery that went on to grow out Propionibacterium. 

Out of concern that the amount of antibiotic eluting from a spacer is small, our practice is to avoid the use of a spacer and instead, after thorough debridement and irrigation, to insert a humeral hemiarthroplasty with Vancomycin-soaked impaction allograft fixation and then to administer IV Cephtriaxone and Vancomycin for six weeks followed by a year of oral Augmentin as described here. Our primary exchange approach has the potential advantage of minimizing the number of surgical procedures. If - as is rarely the case - there is a clinical suspicion of recurrent infection after the primary exchange, another primary exchange is considered.

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