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Shared decision-making in action: Real data on biopsy risk and how to mitigate it
In a study highlighted in a recent issue of CHEST Physician, Hou and colleagues analyzed complications from biopsies of lung abnormalities seen on CT scans by conducting a large retrospective study with data gleaned from national databases of patients undergoing CT- guided biopsy, surgery, or bronchoscopy.1 While it should not be interpreted as representative of a lung cancer screening population (for excellent comments by Drs. Rivera and Silvestri regarding the study, see: https://tinyurl.com/y52ucb94), it does raises two important questions when performing shared decision-making for low dose CT (LDCT) scanning: (1) What information should clinicians discuss with patients regarding various biopsy methods until more data are available? (2) How do we mitigate complications from biopsies?
While procedure-specific biopsy risk may be generalizable, it may be institutionally specific, and knowledge of local skill and outcomes data can help guide discussions. With that said, some general information can inform decisions. The NAVIGATE study investigators recently published their 1-year follow-up results using a navigational bronchoscopy system (superDimension™). While inherent limitations to this study exist, it does provide some useful information as to procedure-related complications from a large sample of patients who approximate a lung cancer screening population. This group was composed of both academic and community centers and prospectively followed 1,215 patients for 1 year.2 The average age of the population was 67.6 (± 11.3), and 80% were current or former smokers. The median nodule size was 2 cm. The diagnostic yield was 73% at 1 year follow-up (data will be re-analyzed at 2 years). The pneumothorax rate was 4%, with 3% requiring chest tube. Hemorrhage occurred in 2.5% of all patients, with 1.5% having a common terminology criteria for adverse events (CTCAE) ≥ 2. Grade 4 respiratory failure occurred in 1 patient. There were no ENB procedure-related deaths. It should be noted that individuals performing these procedures were, by and large, high-volume and experienced users.
In comparison, the overall pooled sensitivity for CT scan-guided biopsy is 90% for pulmonary nodules and masses. The yield is lower, however, for smaller lesions (≤2.0) and ranges from 74% to 77%.3 The average pneumothorax rate is 20%, with 1% to 3% requiring chest tube placement. Risk factors for pneumothorax vary between studies, but, generally speaking, have been associated with nodules ≤ 2 cm, those within 2 cm of the pleura (but not abutting the pleura), and emphysema in the track of needle trajectory. Pulmonary hemorrhage occurs 30% of the time but is mild in most cases. Hemoptysis and severe hemorrhage occur at rates of 4% and <1%, respectively. Risk factors for development of pulmonary hemorrhage include small lesion size (< 2 cm) and lesions > 2 cm from the pleura.
When considering surgical lung biopsies and resection, recent data suggest every effort should be made to encourage smoking cessation in order to mitigate postoperative morbidity. In a retrospective study by Fukui and colleagues,4 respiratory morbidity (defined as hypoxia, pneumonia, atelectasis, and uncontrolled sputum production) was 22% in smokers vs 3.5% in never smokers. The rate of complications decreased as the time from smoking cessation to date of surgery increased.
The goal for each patient who is counseled should be to limit the number of procedures and achieve the greatest diagnostic confidence with the lowest complication rate. With these risks and diagnostic yield in mind, the decision to recommend a particular biopsy strategy (or no biopsy at all) should be based on current guideline recommendations: (1) patient co-morbidities and preferences; (2) size of index nodule or mass; (3) presence of pathologically enlarged mediastinal and/or hilar lymphadenopathy; (4) evidence of extrathoracic metastasis; and (5) institutional expertise. Specifically speaking for the pulmonologist, this translates into identifying specific procedural “champions” who are dedicated to performing these procedures and are members of a multidisciplinary thoracic team. These individuals should have dedicated training in advanced diagnostic procedures to achieve the aforementioned goals.5 The same should hold true for transthoracic, CT-guided biopsies. Interventional pulmonology fellowships are structured to provide exposure to multidisciplinary nodule clinics and tumor boards, establishing quality improvement initiatives, as well as developing procedural expertise.6
It is apparent that shared decision-making can become complex. These details will likely be lost to a primary care provider simply due to time constraints and information overload. As such, pulmonologists should be at the forefront of lung cancer screening – in programmatic development, implementation, and providing education to providers directly involved with shared decision-making discussions.
Dr. Aboudara is with the Division of Allergy, Pulmonary, and Critical Care; Vanderbilt University Medical Center; Nashville, Tennessee.
References
1. Huo J, Xu Y, Sheu T, et al. Complication rates and downstream medical costs associated with invasive diagnostic procedures for lung abnormalities in the community setting: Complications and medical costs associated with diagnostic procedures for lung abnormalities. JAMA Intern Med. 2019;179:324-32.
2. Folch EE, Pritchett MA, Nead MA, et al. Electromagnetic navigation bronchoscopy for peripheral pulmonary lesions: One-year results of the prospective, multicenter NAVIGATE study. J Thorac Oncol. 2019;14(3):445-58.
3. Ohno Y, Hatabu H, Takenaka D, et al. CT-guided transthoracic needle aspiration biopsy of small (< or = 20 mm) solitary pulmonary nodules. AJR Am J Roentgenol. 2003;180(6):1665-69.
4. Fukui M, Suzuki K, Matsunaga T, et al. Importance of smoking cessation on surgical outcome in primary lung cancer. Ann Thorac Surg. 2019;107(4):1005-09.
5. Mahajan A, Khandhar S, Folch EE. Pulmonary Perspectives®: Ensuring quality for EBUS bronchoscopy with varying levels of practitioner experience. CHEST Physician. April 6, 2017. https://tinyurl.com/y3hwlc4g. .
6. Mullon JJ, Burkart KM, Silvestri G, et al. Interventional Pulmonology Fellowship Accreditation Standards: Executive summary of the Multisociety Interventional Pulmonology Fellowship Accreditation Committee. Chest. 2017;151(5):1114-21.
In a study highlighted in a recent issue of CHEST Physician, Hou and colleagues analyzed complications from biopsies of lung abnormalities seen on CT scans by conducting a large retrospective study with data gleaned from national databases of patients undergoing CT- guided biopsy, surgery, or bronchoscopy.1 While it should not be interpreted as representative of a lung cancer screening population (for excellent comments by Drs. Rivera and Silvestri regarding the study, see: https://tinyurl.com/y52ucb94), it does raises two important questions when performing shared decision-making for low dose CT (LDCT) scanning: (1) What information should clinicians discuss with patients regarding various biopsy methods until more data are available? (2) How do we mitigate complications from biopsies?
While procedure-specific biopsy risk may be generalizable, it may be institutionally specific, and knowledge of local skill and outcomes data can help guide discussions. With that said, some general information can inform decisions. The NAVIGATE study investigators recently published their 1-year follow-up results using a navigational bronchoscopy system (superDimension™). While inherent limitations to this study exist, it does provide some useful information as to procedure-related complications from a large sample of patients who approximate a lung cancer screening population. This group was composed of both academic and community centers and prospectively followed 1,215 patients for 1 year.2 The average age of the population was 67.6 (± 11.3), and 80% were current or former smokers. The median nodule size was 2 cm. The diagnostic yield was 73% at 1 year follow-up (data will be re-analyzed at 2 years). The pneumothorax rate was 4%, with 3% requiring chest tube. Hemorrhage occurred in 2.5% of all patients, with 1.5% having a common terminology criteria for adverse events (CTCAE) ≥ 2. Grade 4 respiratory failure occurred in 1 patient. There were no ENB procedure-related deaths. It should be noted that individuals performing these procedures were, by and large, high-volume and experienced users.
In comparison, the overall pooled sensitivity for CT scan-guided biopsy is 90% for pulmonary nodules and masses. The yield is lower, however, for smaller lesions (≤2.0) and ranges from 74% to 77%.3 The average pneumothorax rate is 20%, with 1% to 3% requiring chest tube placement. Risk factors for pneumothorax vary between studies, but, generally speaking, have been associated with nodules ≤ 2 cm, those within 2 cm of the pleura (but not abutting the pleura), and emphysema in the track of needle trajectory. Pulmonary hemorrhage occurs 30% of the time but is mild in most cases. Hemoptysis and severe hemorrhage occur at rates of 4% and <1%, respectively. Risk factors for development of pulmonary hemorrhage include small lesion size (< 2 cm) and lesions > 2 cm from the pleura.
When considering surgical lung biopsies and resection, recent data suggest every effort should be made to encourage smoking cessation in order to mitigate postoperative morbidity. In a retrospective study by Fukui and colleagues,4 respiratory morbidity (defined as hypoxia, pneumonia, atelectasis, and uncontrolled sputum production) was 22% in smokers vs 3.5% in never smokers. The rate of complications decreased as the time from smoking cessation to date of surgery increased.
The goal for each patient who is counseled should be to limit the number of procedures and achieve the greatest diagnostic confidence with the lowest complication rate. With these risks and diagnostic yield in mind, the decision to recommend a particular biopsy strategy (or no biopsy at all) should be based on current guideline recommendations: (1) patient co-morbidities and preferences; (2) size of index nodule or mass; (3) presence of pathologically enlarged mediastinal and/or hilar lymphadenopathy; (4) evidence of extrathoracic metastasis; and (5) institutional expertise. Specifically speaking for the pulmonologist, this translates into identifying specific procedural “champions” who are dedicated to performing these procedures and are members of a multidisciplinary thoracic team. These individuals should have dedicated training in advanced diagnostic procedures to achieve the aforementioned goals.5 The same should hold true for transthoracic, CT-guided biopsies. Interventional pulmonology fellowships are structured to provide exposure to multidisciplinary nodule clinics and tumor boards, establishing quality improvement initiatives, as well as developing procedural expertise.6
It is apparent that shared decision-making can become complex. These details will likely be lost to a primary care provider simply due to time constraints and information overload. As such, pulmonologists should be at the forefront of lung cancer screening – in programmatic development, implementation, and providing education to providers directly involved with shared decision-making discussions.
Dr. Aboudara is with the Division of Allergy, Pulmonary, and Critical Care; Vanderbilt University Medical Center; Nashville, Tennessee.
References
1. Huo J, Xu Y, Sheu T, et al. Complication rates and downstream medical costs associated with invasive diagnostic procedures for lung abnormalities in the community setting: Complications and medical costs associated with diagnostic procedures for lung abnormalities. JAMA Intern Med. 2019;179:324-32.
2. Folch EE, Pritchett MA, Nead MA, et al. Electromagnetic navigation bronchoscopy for peripheral pulmonary lesions: One-year results of the prospective, multicenter NAVIGATE study. J Thorac Oncol. 2019;14(3):445-58.
3. Ohno Y, Hatabu H, Takenaka D, et al. CT-guided transthoracic needle aspiration biopsy of small (< or = 20 mm) solitary pulmonary nodules. AJR Am J Roentgenol. 2003;180(6):1665-69.
4. Fukui M, Suzuki K, Matsunaga T, et al. Importance of smoking cessation on surgical outcome in primary lung cancer. Ann Thorac Surg. 2019;107(4):1005-09.
5. Mahajan A, Khandhar S, Folch EE. Pulmonary Perspectives®: Ensuring quality for EBUS bronchoscopy with varying levels of practitioner experience. CHEST Physician. April 6, 2017. https://tinyurl.com/y3hwlc4g. .
6. Mullon JJ, Burkart KM, Silvestri G, et al. Interventional Pulmonology Fellowship Accreditation Standards: Executive summary of the Multisociety Interventional Pulmonology Fellowship Accreditation Committee. Chest. 2017;151(5):1114-21.
In a study highlighted in a recent issue of CHEST Physician, Hou and colleagues analyzed complications from biopsies of lung abnormalities seen on CT scans by conducting a large retrospective study with data gleaned from national databases of patients undergoing CT- guided biopsy, surgery, or bronchoscopy.1 While it should not be interpreted as representative of a lung cancer screening population (for excellent comments by Drs. Rivera and Silvestri regarding the study, see: https://tinyurl.com/y52ucb94), it does raises two important questions when performing shared decision-making for low dose CT (LDCT) scanning: (1) What information should clinicians discuss with patients regarding various biopsy methods until more data are available? (2) How do we mitigate complications from biopsies?
While procedure-specific biopsy risk may be generalizable, it may be institutionally specific, and knowledge of local skill and outcomes data can help guide discussions. With that said, some general information can inform decisions. The NAVIGATE study investigators recently published their 1-year follow-up results using a navigational bronchoscopy system (superDimension™). While inherent limitations to this study exist, it does provide some useful information as to procedure-related complications from a large sample of patients who approximate a lung cancer screening population. This group was composed of both academic and community centers and prospectively followed 1,215 patients for 1 year.2 The average age of the population was 67.6 (± 11.3), and 80% were current or former smokers. The median nodule size was 2 cm. The diagnostic yield was 73% at 1 year follow-up (data will be re-analyzed at 2 years). The pneumothorax rate was 4%, with 3% requiring chest tube. Hemorrhage occurred in 2.5% of all patients, with 1.5% having a common terminology criteria for adverse events (CTCAE) ≥ 2. Grade 4 respiratory failure occurred in 1 patient. There were no ENB procedure-related deaths. It should be noted that individuals performing these procedures were, by and large, high-volume and experienced users.
In comparison, the overall pooled sensitivity for CT scan-guided biopsy is 90% for pulmonary nodules and masses. The yield is lower, however, for smaller lesions (≤2.0) and ranges from 74% to 77%.3 The average pneumothorax rate is 20%, with 1% to 3% requiring chest tube placement. Risk factors for pneumothorax vary between studies, but, generally speaking, have been associated with nodules ≤ 2 cm, those within 2 cm of the pleura (but not abutting the pleura), and emphysema in the track of needle trajectory. Pulmonary hemorrhage occurs 30% of the time but is mild in most cases. Hemoptysis and severe hemorrhage occur at rates of 4% and <1%, respectively. Risk factors for development of pulmonary hemorrhage include small lesion size (< 2 cm) and lesions > 2 cm from the pleura.
When considering surgical lung biopsies and resection, recent data suggest every effort should be made to encourage smoking cessation in order to mitigate postoperative morbidity. In a retrospective study by Fukui and colleagues,4 respiratory morbidity (defined as hypoxia, pneumonia, atelectasis, and uncontrolled sputum production) was 22% in smokers vs 3.5% in never smokers. The rate of complications decreased as the time from smoking cessation to date of surgery increased.
The goal for each patient who is counseled should be to limit the number of procedures and achieve the greatest diagnostic confidence with the lowest complication rate. With these risks and diagnostic yield in mind, the decision to recommend a particular biopsy strategy (or no biopsy at all) should be based on current guideline recommendations: (1) patient co-morbidities and preferences; (2) size of index nodule or mass; (3) presence of pathologically enlarged mediastinal and/or hilar lymphadenopathy; (4) evidence of extrathoracic metastasis; and (5) institutional expertise. Specifically speaking for the pulmonologist, this translates into identifying specific procedural “champions” who are dedicated to performing these procedures and are members of a multidisciplinary thoracic team. These individuals should have dedicated training in advanced diagnostic procedures to achieve the aforementioned goals.5 The same should hold true for transthoracic, CT-guided biopsies. Interventional pulmonology fellowships are structured to provide exposure to multidisciplinary nodule clinics and tumor boards, establishing quality improvement initiatives, as well as developing procedural expertise.6
It is apparent that shared decision-making can become complex. These details will likely be lost to a primary care provider simply due to time constraints and information overload. As such, pulmonologists should be at the forefront of lung cancer screening – in programmatic development, implementation, and providing education to providers directly involved with shared decision-making discussions.
Dr. Aboudara is with the Division of Allergy, Pulmonary, and Critical Care; Vanderbilt University Medical Center; Nashville, Tennessee.
References
1. Huo J, Xu Y, Sheu T, et al. Complication rates and downstream medical costs associated with invasive diagnostic procedures for lung abnormalities in the community setting: Complications and medical costs associated with diagnostic procedures for lung abnormalities. JAMA Intern Med. 2019;179:324-32.
2. Folch EE, Pritchett MA, Nead MA, et al. Electromagnetic navigation bronchoscopy for peripheral pulmonary lesions: One-year results of the prospective, multicenter NAVIGATE study. J Thorac Oncol. 2019;14(3):445-58.
3. Ohno Y, Hatabu H, Takenaka D, et al. CT-guided transthoracic needle aspiration biopsy of small (< or = 20 mm) solitary pulmonary nodules. AJR Am J Roentgenol. 2003;180(6):1665-69.
4. Fukui M, Suzuki K, Matsunaga T, et al. Importance of smoking cessation on surgical outcome in primary lung cancer. Ann Thorac Surg. 2019;107(4):1005-09.
5. Mahajan A, Khandhar S, Folch EE. Pulmonary Perspectives®: Ensuring quality for EBUS bronchoscopy with varying levels of practitioner experience. CHEST Physician. April 6, 2017. https://tinyurl.com/y3hwlc4g. .
6. Mullon JJ, Burkart KM, Silvestri G, et al. Interventional Pulmonology Fellowship Accreditation Standards: Executive summary of the Multisociety Interventional Pulmonology Fellowship Accreditation Committee. Chest. 2017;151(5):1114-21.