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Ann Thorac Surg 2006;82:1185-1190
© 2006 The Society of Thoracic Surgeons

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Original Articles: General Thoracic

Nine-Year Single Center Experience With Cervical Mediastinoscopy: Complications and False Negative Rate

Division of Thoracic Surgery, Duke University Medical Center, Durham, North Carolina

Accepted for publication May 8, 2006.

^_* Address correspondence to Dr Burfeind, Duke University Medical Center, Box 3305, Durham, NC 27710 (Email: burfe001{at}mc.duke.edu).

Presented at the Forty-second Annual Meeting of The Society of Thoracic Surgeons, Chicago, IL, Jan 30–Feb 1, 2006.

	Abstract

Top Abstract Introduction Patients and Methods Results Comment Discussion References

 
BACKGROUND: Mediastinoscopy is a valuable tool for evaluating mediastinal pathology and is essential for establishing treatment strategies in most patients with lung cancer. We sought to determine the complication and false negative rate for mediastinoscopy in an institution that routinely performs this procedure.

METHODS: We performed a retrospective review of 2,145 consecutive mediastinoscopies at a single institution between April 1996 and April 2005. Demographics and complications were analyzed. In patients with lung cancer who underwent subsequent resection, the false negative rate was calculated.

RESULTS: Mean patient age was 61 ± 0.4 years, and 58% (n = 1,253) were male. Pathology included lung cancer (n = 1,459), metastatic disease (n = 78), lymphoma (n = 51), and other benign disease (n = 557). Twenty-three patients (1.07%) experienced complications including hemorrhage (n = 7, 0.33%), vocal cord dysfunction (n = 12, 0.55%), tracheal injury (n = 2, 0.09%), and pneumothorax (n = 2, 0.09%). There was 1 death (0.05%) after pulmonary artery injury. Five of the 7 vascular injuries occurred during biopsy of level 4R. Three hundred and forty-three patients (23.5%) with lung cancer had positive mediastinoscopies. The false negative rate was 56 of 1,019 (5.5%) among lung cancer patients undergoing resection. Thirty-two (57%) of the false negatives were due to metastatic disease in lymph nodes not normally biopsied during cervical mediastinoscopy (levels 5, 6, 8, or 9).

CONCLUSIONS: Although invasive, mediastinoscopy identified locally advanced disease in a significant percentage of this lung cancer population and was associated with a low false negative rate. Complications after mediastinoscopy were uncommon. These results support the continued routine use of mediastinoscopy.

	Introduction

Top Abstract Introduction Patients and Methods Results Comment Discussion References

 
Lung cancer is the leading cause of cancer-related death among women and men [1]. More than 157,600 people died of lung cancer in 2002, representing 28% of all cancer deaths [2]. Accurate staging is a critical part of the management of newly diagnosed nonsmall-cell lung cancer and of the decision to offer patients induction therapy [3]. Currently, surgery is most appropriate for patients within whom disease is confined to the lung and the hilar lymph nodes (stage I and II). For patients with metastatic disease to mediastinal lymph nodes (stage III), the benefit of surgery alone is questionable, and induction therapy followed by surgery may be considered [4]. Both noninvasive and invasive tools are available for identifying tumor involvement in the mediastinum. Traditional noninvasive studies include chest radiography, and computed tomography (CT). The diagnostic criteria for CT scan are based only on size (> 1 cm), and accuracy is approximately 60% [5]. The development of positron emission tomography (PET) scan to diagnosis metastatic disease was heralded as a diagnostic tool that would provide functional as well as anatomical detail and therefore prevent unnecessary surgical interventions. To date, questions regarding its high false positive rate have been a major concern [6].

Mediastinoscopy, the gold standard for mediastinal lymph node staging, has limitations that include its invasiveness, requirement for general anesthesia, potential for complications, and inability to reach all nodal stations [7]. These limitations have fostered the development of additional modalities to facilitate lung cancer staging. The list of available studies includes transthoracic needle aspiration, thoracoscopic biopsy, endosopic ultrasound-guided fine-needle aspiration (EUS-FNA), and endobronchial ultrasound FNA (EBUS-FNA). In light of the development of these diagnostic tools for evaluating the mediastinum, the role of mediastinoscopy may evolve. In an institution that regularly performs cervical mediastinoscopy, we sought to determine the complication rate and false negative rate over a 9-year period.

	Patients and Methods

Top Abstract Introduction Patients and Methods Results Comment Discussion References

 
A retrospective review of a consecutive series of patients undergoing cervical mediastinoscopy between April 1996 and April 2005 was performed with approval and waiver of consent of the Institutional Review Board at Duke University Medical Center. This date range was chosen as it represents the era where dedicated general thoracic surgeons were available. For all patients with suspected lung cancer, mediastinoscopy was routinely performed (unless technically not feasible). Mediastinoscopy was typically performed during the same anesthetic as resection unless the mediastinal nodes were clinically suspicious. Intraoperative complications were assessed by reviewing operative notes, discharge summaries, and thoracic and otolaryngology, head and neck surgery clinic notes. Bleeding complications were those that required another procedure other than simple tamponade to resolve. Vocal cord dysfunction was diagnosed when patients presented postoperatively with a new but unresolving hoarseness as detected by follow-up clinic notes or visits to otolaryngology.

Technique
Mediastinoscopy was performed under general anesthesia by dedicated general thoracic surgeons. A 2-cm to 2.5-cm low cervical transverse incision was made and dissection carried down through the platysma. Dissection then continued between the strap muscles onto the pretracheal plane. This plane was developed into the mediastinum with blunt finger dissection and a mediastinascope (Karl Storz, Tuttlingen, Germany) was inserted. Lymph node stations 2R, 4R, 2L, 4L, 7, and 3, according to the Mountain/Dresler regional nodal stations for lung cancer staging, were examined and biopsied [8, 9]. The biopsies underwent pathology evaluation by hematoxylin and eosin and polychrome staining for frozen section analysis. Specimens were then embedded in paraffin and subject to multiple sectioning and immunohistochemical staining as indicated for permanent sections.

	Results

Top Abstract Introduction Patients and Methods Results Comment Discussion References

 
Between April 1996 and April 2005, 2,145 patients underwent cervical mediastinoscopy for pathology evaluation of the mediastinum. Table 1 summarizes the patient demographics. Of the total patient population, 1,459 (68%) were diagnosed with either nonsmall-cell lung cancer (n = 1,399 or small-cell lung cancer (n = 60). Three hundred and forty-three patients (23.5%) with lung cancer were diagnosed with nodal metastasis to the mediastinum (nonsmall-cell lung cancer = 300, small-cell lung cancer = 43). Of these, 80 patients underwent induction therapy and 56 went on to resection (Table 2). The majority of the patients, 287 of 343 (84%) diagnosed with N2/3 disease did not undergo definitive resection and therefore were spared additional major surgical procedures.

	Comment

Top Abstract Introduction Patients and Methods Results Comment Discussion References

Hemorrhagic complications are among the most feared and occurred in 7 patients (0.33%) within our cohort. This rate is similar to that reported by Park and colleagues [10] from Memorial Sloan-Kettering. In their series of 3,391 mediastinoscopies, major hemorrhage occurred in 14 patients (0.44%). Both series show the most common biopsy site resulting in hemorrhage to be the lower right paratracheal node (level 4R). In 8 of 14 patients in the Memorial series, an additional incision was required to manage the patient's hemorrhage, with the remaining patients treated with packing through their cervical incision. This current series did not consider bleeding that stopped with simple tamponade as a complication. The majority of patients in our study, 5 of 7, had bleeding that required further exposure with either a median sternotomy or posterolateral thoracotomy depending on the origin of the bleeding and site of the tumor. Interestingly, 2 patients with azygous vein injuries were able to be managed with endoscopic clip applicators through the mediastinascope. Importantly, the 1 death in our series occurred in an elderly lung cancer patient after a vascular injury to the right main pulmonary artery. Despite attempted repair on cardiopulmonary bypass, right pneumonectomy was required and was ultimately not tolerated.

The data presented here are remarkably similar to the data obtained from Washington University over the decade previous to this series (1988 to 1998) [7]. Hammoud and coworkers [7] reported 2,137 patients undergoing cervical mediastinoscopy and found complications in only 12 patients (0.6%). The majority of complications were secondary to arrhythmias (n = 6), bleeding (n = 1), vascular injury (n = 1), and pneumothorax (n = 1). The authors' acknowledged, however, that the number of complications may have been higher because of an inability to document additional complications such as vocal cord dysfunction secondary to a lack of long-term follow-up. Vocal cord dysfunction was specifically looked for in this study and, in fact, the incidence may have been slightly higher if patients were treated by otolaryngologists outside of the Duke system. Although Hammoud and colleagues [7] identified 4 perioperative deaths, only 1 (0.05%) was directly related to mediastinoscopy. Looking at these two series combined, it seems safe to say that cervical mediastinoscopy, when performed regularly, should have a morbidity of 1% or less and a mortality of about 1 in 2,000.

Accurate staging is essential in the management of patients with lung cancer. Selecting a single diagnostic study that is both safe and completely stages the entire mediastinum would be ideal. Standard cervical mediastinoscopy is ideally suited to the biopsy of lymph nodes within levels 2, 3, 4, and 7; whereas posterior subcarinal, pulmonary ligament, and subaortic nodes are usually inaccessible. This shortcoming of mediastinoscopy is highlighted by an analysis of the false negatives within this cohort. We found that 56 of the 1,019 patienst (5.5%) with lung cancer who went on to resection actually harbored metastatic disease in N2 nodes. The false negative rate in the Washington University series was similar at 8% (76 of 947). Both series found that most of the false negatives occurred in N2 nodes that are not biopsied during cervical mediastinoscopy; 32 of 56 in this series and 56 of 76 in the Washington University series.

Although the presence of these false negatives is not a true failure of mediastinoscopy, it does indicate that it was not successful in completely staging the mediastinum in these patients. The false negative rate of mediastinoscopy appears to be decreasing slightly with time. The false negative rates for series gathered between 1979 and 1984, 1988 and 1998, and 1996 and 2005 were 8.8%, 8.0%, and 5.5%, respectively [7, 11]. An explanation for the most recent decrease in the false negative rate may be the increasing use of PET/CT in the evaluation of patients with lung cancer. Any PET activity within mediastinal lymph nodes certainly helps direct biopsies and probably prompts surgeons to more thoroughly biopsy certain levels. In this way, thoracic surgeons are not only biopsying lymph nodes based on solely size but also lymph nodes with evidence of increased metabolic activity.

In this single center experience, cervical mediastinoscopy altered the course of management in 24% of patients diagnosed with lung cancer. The majority of these patients, who were not induction therapy candidates, were spared further invasive procedures. In addition, patients with single station N2 disease were given the opportunity to receive neoadjuvant therapy, and in many cases (56 of 343) went on to complete resection. Although the ideal treatment for patients with N2/N3 disease has not been fully established, correctly identifying these patients allows for proper staging and protocol enrollment.

Newer diagnostic modalities are being employed to identify metastatic disease within the mediastinum but do not appear ready to replace mediastinoscopy. Positron emission tomography scans are a common noninvasive tool that can help detect both mediastinal and distant metastatic disease. However, studies have reported its accuracy to be 74% to 90% [6, 12, 13]. In addition, the high false positive rate mandates that mediastinoscopy confirm nodal positivity. Positron emission tomography scans have not been shown to reduce the number of patients who ultimately proceed with more extensive surgery. In Viney and colleagues [14], 184 patients were randomly assigned to two trial arms, one with PET and the other without PET. The findings from their study showed that although PET scans affected management in 13% of patients, there was no significant difference in terms of number of thoracotomies. The combination of PET with CT scans has improved the overall accuracy of PET [15].

Endosopic ultrasound-guided fine-needle aspiration has also been used to sample enlarged mediastinal lymph nodes. In a recent study, EUS-FNA was shown to prevent 70% of scheduled surgical intervention in patients with suspected lung cancer because of the demonstration of mediastinal metastases or tumor invasion or by establishing an alternative diagnosis [16]. This work was also supported by Larsen and coworkers [17] who found, of 84 patients with enlarged mediastinal lymph nodes, that 49% of planned thoracotomies/thorascopies and 68% of planned mediastinoscopies could be cancelled because of EUS results [17]. These studies address only patients with enlarged or suspect mediastinal lymph nodes and do not address the patients found to have microscopic metastases. Additionally, paratracheal and subaortic (level 2, 4, 5 and 6) lymph nodes are not easily biopsied using EUS-FNA. Endosopic ultrasound-guided FNA, however, is routinely able to access posterior mediastinal lymph nodes (levels 8 and 9). Described complication rates for EUS-FNA are low, ranging from 0% to 4% [18–21]. Although rare, possible risks include perforation and bleeding [22]. In our study, 9 of the 56 false negatives (16%) were due to metastatic disease in level 8 or 9. The complementary use of EUS-FNA and mediastinoscopy in patients with enlarged pulmonary ligament nodes provides an opportunity to further reduce the overall false negative rate.

While EUS-FNA and mediastinoscopy may be complimentary to each other, the future of additional diagnostic tools is uncertain. Endobronchial ultrasound FNA has been used mainly to determine the depth of tracheobronchial invasion and its overall impact on diagnosing mediastinal disease requires further investigation. Its ability to biopsy paratracheal lymph nodes may make it attractive as the procedure matures [23]. This procedure may be especially attractive in patients with a suspected positive N2 node who are induction therapy candidates. By utilizing EBUS-FNA to first confirm the N2 status, cervical mediastinoscopy can be used to restage the mediastinum, before planned resection, without the need for a redo procedure. Transthoracic needle biopsy has been promoted as less invasive than mediastinoscopy, but its high risk of pneumothorax (10% to 60%) with subsequent need for chest tube placement (15% to 25%) and bleeding risk has limited the enthusiasm of its use [24].

Although mediastinoscopy remains the gold standard for staging the mediastinum in lung cancer patients, it is still used infrequently in general practice. In the recent survey by Little and associates [25], the authors reported that the mediastinum was evaluated by mediastinoscopy in only 27.1% of 11,668 patients with surgically treated lung cancer. In addition, lymph nodes were biopsied in only 46.6% of those patients who underwent mediastinoscopy. Hopefully, these results highlight the need for continuing education of all surgeons who take care of patients with lung cancer.

Mediastinoscopy remains a safe and effective tool for the evaluation of mediastinal pathology. In patients with known or suspected lung cancer, the routine use of mediastinoscopy can change the plan of care for as many as a quarter of patients. Complimentary diagnostic modalities may help reduce the overall false negative rate by both directing biopsies to suspicious nodes and providing access to lymph nodes not reachable by cervical mediastinoscopy. These data support the continued use of routine mediastinoscopy in the lung cancer patient and highlight how new technology can help us approach the Holy Grail of complete mediastinal staging.

	Discussion

Top Abstract Introduction Patients and Methods Results Comment Discussion References

 
DR LARRY R. KAISER (Philadelphia, PA): You reported in your abstract on vocal cord dysfunction in 20 patients, although you report fewer than this today. Please clarify for me the false negatives in the abstract that were reported at 1.8% and you reported on 56 false negatives in the presentation.

I guess the other thing is, when you start talking about complications, it really depends on what procedure you're doing. The patient with bulky mediastinal adenopathy in whom you go in and you biopsy a right paratracheal node, that's different than somebody in whom you're going in and sampling right level 2, 4, level 7, and left level 4. First of all, tell us what your standard mediastinoscopy procedure entails. Do you have any sense as to what percentage of these patients had all levels biopsied, because that gives us a better index in terms of the overall complication rate.

DR LEMAIRE: There were some differences between our abstract and the presentation today in terms of the number of patients with vocal cord dysfunction. Initially, in our abstract we reported 20 vocal cord injuries, and today it is only 12; the reason is because there were 8 patients actually who had vocal cord paralysis before their initial mediastinoscopy, which was not identified before the abstract being submitted. As well with the false negative rate, on our initial inspection we found only 17, but after reviewing the data multiple times, we ended up finding 56 in total.

I agree with your comment on the clinical situation determining the true risk of complications from a procedure. Regarding the procedure for mediastinoscopy, we perform a standard mediastinoscopy, as do most programs, with a standard cervical incision, 2 cm above the sternal notch and then developing the pretracheal plane. Next, a careful inspection and biopsy of lymph node stations are performed. So there is no difference in terms of our procedure than would be expected by any other program. Regarding the percentage of levels biopsied for each person, that was not one of our main endpoints that we were looking for when we started off this project, and so I cannot give you a number of lymph nodes that were identified for each patient.

DR SCOTT J. SWANSON (New York, NY): I enjoyed your presentation. Do you have any experience with video-mediastinoscopy, and if you do, would you or your coauthors comment on the role of that in the teaching institution. Does that make the procedure easier to teach to residents and fellows?

DR LEMAIRE: Doctor D'Amico or Dr Harpole, would you comment on the video-mediastinoscopy? Thank you, Dr Burfeind.

DR WILLIAM R. BURFEIND (Durham, NC): We actually don't perform video-mediastinoscopy but rather utilize a standard mediastinascope. We have looked at one of the video systems, and just due to the bulkiness of the scope, we haven't adopted it yet. It is a challenging technique to teach, but because we do it frequently, we have standardized the teaching technique. Initially, faculty identify the nodes for the residents and have them biopsy them once they have been dissected out. Residents then do more and more of the dissection, and we just check to make sure they are biopsying the right thing before they do it. With time, they are able to accomplish the entire procedure without any difficulty.

DR SWANSON: I think one point that might help me understand mediastinoscopy in this era pertains to how many of those positive mediastinoscopies surprised you? In other words, were all the patients thought to be negative going in or were some of the patients thought to be positive at the time?

DR LEMAIRE: I think in the majority of those patients we were not surprised that they were positive. I would have to defer to Dr Burfeind and Dr D'Amico for their specific comments on that since they performed the majority of those procedures.

DR SWANSON: I guess the follow-up question is, when should we be doing mediastinoscopy? Granted it's associated with a low complication rate, but when does it change your therapeutic approach, and is there another less invasive way to get the same information?

DR THOMAS A. D'AMICO (Durham, NC): Scott, to answer two of the questions, I'll refer to the last series of mediastinoscopy that we reviewed, a comparison of mediastinoscopy and PET. In that series the mean number of lymph node stations sampled was 4.5, a relatively thorough mediastinoscopy, and 16% of patients who had negative PETs and negative CT still had a positive mediastinoscopy. So it's not uncommon to find unexpected lymph nodes and we remain liberal with our use of mediastinoscopy. If you look at our series as well as the recent American College of Surgeons series on mediastinoscopy and PET, I think you can safely avoid mediastinoscopy if the tumor is less than 3 cm and the lymph nodes are negative on PET and CT. We only found one occult T1N2 patient. All the other occults were T2N2 or greater; T3N2, T2N3. So if the T status is really T1 only and the CT is negative and the PET is negative, the false negative rate of that clinical staging is relatively low.

DR DANIEL G. CAVANAUGH (Eau Claire, WI): I practice thoracic surgery in a small community hospital and have recently started using the video-mediastinoscope, and it certainly has made the operation easier, and I think it's safer and it's simple to learn to use. The last thing I would say, your vocal cord paralysis, do you use Bovie down inside that mediastinoscope? It has been my experience that you should never do that.

DR LEMAIRE: No, sir, we do not.

DR DAVID H. HARPOLE, JR (Durham, NC): I guess we're playing round robin here. No. I can tell you, looking at them, because unfortunately some of those were mine, is that it generally was someone with a left-sided lesion where we wanted to do a real thorough investigation of the left paratracheal stripe, and we're very careful not to use Bovie, and we usually try to identify the nerve and not directly touch it, but I think the injuries are probably, frankly, underreported in the literature, and so we're trying to be honest, but we do not Bovie on the nerve.

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Top Abstract Introduction Patients and Methods Results Comment Discussion References

 

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