Dr. Mahajan and colleagues present a compelling case for requiring minimum standards to perform an EBUS-guided bronchoscopy. Their opinion piece epitomizes the classic tension between physicians with advanced training and those who can only have practice-based training. A middle ground may exist, as perhaps competence could be achieved by simulation, clinical cases performed, and observation by a regional expert? Physicians in practice must have a pathway to adopt new technology whether it is thoracic ultrasound or endobronchial ultrasound, but it must be done in a safe manner. As a referring physician, I would only send my patients who required mediastinal staging to a pulmonologist who I knew performed EBUS regularly.
Nitin Puri, MD, FCCP
Endobronchial ultrasound (EBUS) bronchoscopy is a tool that has transformed the diagnosis and staging of lung cancer. Through real-time ultrasound imaging, EBUS provides clear images of lymph nodes and proximal lung masses that can be adequately sampled through transbronchial needle aspiration. EBUS is a minimally invasive, outpatient procedure that can also be used for diagnosing benign disease within the chest. Large studies investigating the use of EBUS for mediastinal staging have shown the procedure to be highly sensitive and specific while harboring an excellent safety profile.1 As a result, EBUS has essentially replaced mediastinoscopy for the staging of lung cancer.
EBUS bronchoscopy was primarily offered at major academic centers when first released and was performed by physicians who were formally trained in the procedure during interventional pulmonology or thoracic surgery fellowships. Over time, the tool has been adopted by established general pulmonologists without formal training in EBUS. Some of these pulmonologists only develop their skills by attending 1- to 2-day courses, which is insufficient supervision to become competent in this important procedure.
An ongoing debate continues as to how many supervised EBUS bronchoscopies should be performed prior to being considered proficient.2 As procedural competence has been associated with the number of EBUS procedures performed, the learning curve required to master EBUS is an important component of proficiency. While most consider learning curves to be variable, evidence produced by Fernandez-Villar and colleagues revealed that EBUS performance continues to improve up to 120 procedures.3 This analysis was performed in unselected consecutive patients based on diagnostic yield, procedure length, number of lymph nodes passes performed in order to obtain adequate samples, and the number of lymph nodes studied per patient. The learning curve was evaluated based on consecutive groups of 20 patients, the number of adequate samples obtained, and the diagnostic accuracy. Their results indicated that the diagnostic effectiveness of EBUS-TBNA improves with increasing number of procedures performed, allowing for access to a greater number of lymph nodes without necessarily increasing the length of the procedure, and by reducing the number of punctures at each nodal station. Based on their results, the first 20 procedures performed yielded a 70% accuracy, 21 to 40 procedures performed resulted in 81.8% accuracy, 41 to 60 procedures performed resulted in 83.3% accuracy, 61 to 80 procedures performed resulted in 89.8% accuracy, 81 to 100 procedures performed resulted in 90.5% accuracy, and 101 to 120 procedures performed resulted in 94.5% accuracy.
While the American Thoracic Society (ATS) and the American College of Chest Physicians (CHEST) both recommend a minimum number of 40 to 50 supervised EBUS bronchoscopies prior to performing the procedure independently, along with 20 procedures per year for maintenance of competency, most institutions do not track the number of EBUS procedures performed and they do not follow the ATS or CHEST recommendations.4,5 As a result, a number of physicians are independently performing EBUS without adequate experience, resulting in possibly poor quality care. Unfortunately, some short courses, intended to generate interest and encourage attendees to pursue further training, are mistakenly assumed to be sufficient by the novice user.
As the number of interventional pulmonary fellowships continues to expand, the growing number of subspecialized pulmonologists with extensive training in EBUS grows. During a dedicated interventional pulmonary fellowship, fellows perform well above the number of EBUS bronchoscopies suggested by the ATS and CHEST in a single year. Recently published accreditation guidelines require a minimum of 100 cases per interventional pulmonary fellow.6 These fellowship-trained interventional pulmonologists are then tested to become board-certified in a wide array of minimally invasive procedures, including EBUS. As a result, a model has developed where both board-certified interventional pulmonologists with extensive training in EBUS and general pulmonologists not meeting ATS or CHEST minimum requirements practice at the same institution. Proponents of a more liberal access to credentialing in EBUS have suggested that adhering to competency requirements constitutes a “barrier to entry” in which incumbent practitioners benefit from limiting competition. However, like any other regulatory metric, the rationale is to prevent asymmetric information. In this example, the physician knows more than the patient. The patient cannot make an informed decision on which provider to choose and what are the minimum requirements that are likely to produce the most useful information (ie, complete staging). For these reasons, it is imperative that regulations protect the patient.
Without question, EBUS bronchoscopy should not be performed only by board-certified interventional pulmonologists. Instead, hospital credentialing committees should adhere to both the ATS and CHEST recommendations for the number of supervised cases necessary prior to performing EBUS independently. As EBUS use continues to grow, fellows in 3- or 4-year pulmonary and critical care fellowships will be likely capable of meeting the minimal number of observed cases, but, if these numbers are not achieved, additional training should be required. Understandably, this could be challenging for physicians who are unable to take time away from their practice to gain this training. However, if these numbers cannot be met, credentialing requirements should be enforced.
Even more challenging than establishing quality measures for EBUS, is to ensure the highest level of care delivery for patients when there exist multiple levels of experience in the same institution. Undoubtedly, patients undergoing EBUS bronchoscopy, or any procedure for that matter, would want the most skilled physician who has attained certification in the procedure. Unfortunately, no formal certification of EBUS exists outside of gaining board certification in interventional pulmonology. To ensure excellence in care, physicians performing EBUS should be involved in quality improvement initiatives and review pathologic yields along with complications on a regular basis in a group setting. Unlike emergency interventions, EBUS bronchoscopy is an entirely elective procedure.
The advent of EBUS bronchoscopy has revolutionized the diagnosis and staging of lung cancer. As use of EBUS continues to become more widespread, the incidence of high volume and low volume proceduralists will become a more commonly encountered scenario. Guidelines have been set by the professional pulmonary societies based on the data and observations available. At the local level, stringent guidelines need to be established by hospitals to ensure a high level of quality with appropriate oversight. Patients undergoing EBUS deserve a physician who is skilled in the procedure and has performed at least the minimum number of procedures to provide the adequate care.
Dr. Mahajan is Medical Director, Interventional Pulmonology, Inova Heart and Vascular Institute - Inova Fairfax Hospital, and Associate Professor, Virginia Commonwealth Medical School; Dr. Khandhar is Medical Director, Thoracic Surgery, Inova Heart and Vascular Institute - Inova Fairfax Hospital, and Assistant Clinical Professor, Virginia Commonwealth Medical School; Falls Church, VA. Dr. Folch is Co-Director, Interventional Pulmonology Chief, Complex Chest Diseases Center, Harvard Medical School, Massachusetts General Hospital, Boston, MA.
References
1. Gomez M, Silvestri GA. Endobronchial ultrasound for the diagnosis and staging of lung cancer. Proc Am Thorac Soc. 2009;6(2):180-186.
2. Folch E, Majid A. Point: Are >50 Supervised Procedures Required to Develop Competency in Performing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration for Mediastinal Staging? Yes. Chest. 2013;143(4):888-891.
3. Fernandez-Villar A, Leiro-Fernandez V, Botana-Rial M, Represas-Represas C, Nunez-Delgado M. The endobronchial ultrasound-guided transbronchial needle biopsy learning curve for mediastinal and hilar lymph node diagnosis. Chest. 2012; 141(1):278-279.
4. Ernst A, Silvestri GA, Johnstone D. Interventional pulmonary procedures: Guidelines from the American College of Chest Physicians. Chest. 2003;123(5):1693-1717.
5. Bolliger CT, Mathur PN, Beamis JF, et al. ERS/ATS statement on interventional pulmonology. European Respiratory Society/American Thoracic Society. Eur Respir J. 2002;19(2):356-373.
6. Mullon JJ, Burkhart KM, Silvestri G. Interventional Pulmonology Fellowship Accreditation Standards: Executive Summary of the Multi-society Interventional Pulmonology Fellowship Accreditation Committee. Chest. 2017. doi:10.1016/j.chest.2017.01.024.