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Periprocedural Major Bleeding Risk of Image-Guided Percutaneous Chest Tube Placement in Patients with an Elevated International Normalized Ratio
CLINICAL STUDY
Periprocedural Major Bleeding Risk of Image-Guided Percutaneous Chest Tube Placement in Patients with an Elevated International Normalized Ratio Patrick. J. Navin, MBBChBAO, Mariah L. White, MD, Francis C. Nichols, MD, Darlene R. Nelson, MD, John J. Mullon, MD, Jennifer S. McDonald, PhD, Thomas D. Atwell, MD, and Michael R. Moynagh, MBBChBAO, MRCSI, FFRCSI ABSTRACT Purpose: To evaluate the incidence of major hemorrhage after image-guided percutaneous chest tube placement in patients with an abnormal international normalized ratio (INR) measured before the procedure. Materials and Methods: Between January 2013 and September 2017, 49 image-guided percutaneous chest tubes were placed in 45 adult patients who had an elevated INR of greater than 1.6. Data collected included routine serum pre-procedure coagulation studies, indication for chest tube placement, insertion technique, size of chest tube, and presence of complications after drain placement. Major bleeding complications were defined using the Society of Interventional Radiology classification system. Results: Mean patient age was 62 years (range, 22–94 years), with median American Society of Anesthesiologists score of 4. Mean INR was 2.1 (range, 1.7–3), with 21 (43%) procedures with an INR between 1.7 and 1.9, 20 (41%) procedures with an INR between 2.0 and 2.4, and 8 (16%) procedures with an INR between 2.5 and 3.0. Computed tomography guidance was used for 27 (55%) procedures; ultrasound guidance was used for 22 (45%) procedures. Median size of chest tube was 10 Fr (range, 8–14 Fr) used in 27 (55%) procedures. No major bleeding complications were observed. There was a small, significant decrease in mean hemoglobin after the procedure (mean ¼ 0.9g/dL; P < .0001), which correlated to increasing chest tube size (P ¼ .0269). Conclusions: No major bleeding complications were observed after image-guided percutaneous chest tube placement in patients with an elevated INR. Major bleeding complications in these patients may be safer than initially considered, and this study encourages the conduct of larger trials for further evaluation.
ABBREVIATION INR ¼ international normalized ratio
Percutaneous image-guided small bore chest tube (chest pleural catheter) placement is a commonly performed procedure for the treatment of pneumothorax and pleural
From the Departments of Radiology (P.J.N., M.L.W., J.S.M., T.D.A., M.R.M.), General Thoracic Surgery (F.C.N.), and Pulmonary and Critical Care Medicine (D.R.N., J.J.M.), Mayo Clinic, 200 First Street SW, Rochester, MN, 55905. Received June 22, 2018; final revision received July 1, 2019; accepted July 2, 2019. Address correspondence to M.R.M.; E-mail: moynagh.michael@ mayo.edu None of the authors have identified a conflict of interest. © SIR, 2019 J Vasc Interv Radiol 2019; 30:1765–1768 https://doi.org/10.1016/j.jvir.2019.07.002
effusions, with over 1 million placed annually (1). Minor bleeding rates have been reported between 1% and 2% for ultrasound-guided chest tube placement with normal coagulation profiles (2,3). Prior management guidelines have considered chest tube placement to be a procedure of moderate risk for bleeding, with a recommendation to correct underlying coagulopathy prior to intervention (4,5). Although helpful, these guidelines have lacked sufficient evidence to support such management and may even place patients at risk when reversing clinically indicated anticoagulation (6,7). Evidence is available to support the safety of thoracentesis in patients with abnormal serum screening studies (5,8,9). No studies are available evaluating the same bleeding risk related to percutaneous chest tube placement in such potentially high-risk patients.
1766 ▪ Percutaneous Chest Tube Placement in Patients with an Elevated INR
The purpose of the current study was to evaluate the incidence of major hemorrhage after image-guided percutaneous chest tube placement at a single institution in adult patients with a suspected increased risk of bleeding due to abnormal pre-procedural international normalized ratio (INR) coagulation profile.
Table 1. Demographics and Procedural Details N Male/Female
49 catheters placed in 45 patients 26/19
Age
Mean, 62 years (range, 22–94)
ASA score
Median, 4 (range, 3–5)
Indications for tube
Pneumothorax ¼ 20 (41%) Pleural effusion ¼ 11 (22%) Empyema ¼ 12 (24%) Hydro-pneumothorax ¼ 6 (12%)
Indication for elevated INR >1.6
Cardiac valve prosthesis ¼ 26 (53%) Atrial fibrillation ¼ 10 (21%) LVAD ¼ 5 (10%) Liver disease ¼ 4 (8%) Pulmonary embolism ¼ 3 (6%) Sepsis ¼ 1 (2%)
Comorbidities
Perioperative period after CABG, prosthetic valve placement, heart transplant, pulmonary lobectomy, LVAD placement, thoracic aortic aneurysm repair, extracardiac fontan, Ivor Lewis esophagectomy, and pacemaker placement. Severe heart failure, malignant effusion, immunosuppression from solid organ transplant, chemotherapy, AML, severe sepsis, pneumonia, and hemorrhagic pancreatitis
MATERIALS AND METHODS This single-center retrospective study was approved by the local institutional review board and is compliant with the Health Insurance Portability and Accountability Act. Based on billing codes, a review of institutional electronic medical records identified 869 consecutive adult patients aged 18 years or older who underwent either ultrasound- or computed tomography (CT)-guided percutaneous chest tube placement between January 2013 and July 2017. Patients were included in the final study cohort if they had an INR greater than 1.6 at the time of the procedure. Threshold laboratory values were chosen based on protocols at the performing institution for invasive procedures. Patients were excluded if they had undergone preprocedural corrective transfusion with fresh frozen plasma, or similar product, with laboratory confirmation of INR normalization (INR <1.6). Patients were included if they had failed attempted INR correction, with the INR remaining greater than 1.6 on a repeat laboratory draw performed in the interim between transfusion and procedure. In these cases, the patient’s lowest INR prior to the procedure was used for analysis. Patients were excluded if they had undergone pre-procedural corrective transfusion but had not had a subsequent INR rechecked in the interim between transfusion and chest tube placement. All procedures were performed in patients with a serum platelet count greater than 50 x 109/L. Indication for corrective transfusion was a multidisciplinary decision between the ordering clinical team and the proceduralist and was primarily based on the urgency of the procedure and indication for anticoagulation. Additional exclusion criteria included patients who specifically declined authorization for research. The final study cohort included 45 patients who underwent 49 percutaneous chest tube placements during the study period. Three patients were excluded who had their charts labeled as not authorized for research. Mean patient age was 62 years (range, 22–94 years), with median American Society of Anesthesiologists score of 4 (range, 3–5). Forty-three (88%) procedures were performed in patients without attempted INR correction. Six (12%) procedures were performed in patients who had failed attempted INR correction. The most common indication for chest tube placement was pneumothorax in 20 (41%) patients, followed by pleural effusion compromising respiratory status in 11 (22%) patients, empyema in 12 (24%) patients, and hydro-pneumothorax in 6 (12%) patients. Additional demographics are outlined in Table 1.
Navin et al ▪ JVIR
AML ¼ acute myeloid leukemia; ASA ¼ American Society of Anesthesiologists; CABG ¼ coronary artery bypass graft; INR ¼ international normalized ratio; LVAD ¼ left ventricular assist device.
Chest Tube Placement Technique Ultrasound-guided procedures were performed by either an interventional radiologist or a pulmonologist, with CTguided procedures performed by an interventional radiologist (median years of experience, 9; range, 1–25 years). Decision for CT versus ultrasound guidance was at the discretion of the interventional radiologist, based primarily on indication for chest tube, patient comorbidities, and morphology. Selection of tube size was based on clinical indication and operator preference. There was no specific change in technique to mitigate the potential risk of bleeding. For each procedure, the patient was prepared and draped in a sterile fashion, and 1% lidocaine was used for local anesthetic, typically using a 25-gauge needle. A small skin incision was made at the discretion of the interventionist. Ultrasound procedures were performed with 2 separate techniques based on operator preference. Ultrasound-guided cases employed a trocar technique; alternatively, a Seldinger technique was used. Procedures performed under CT guidance differed in that a Seldinger technique was exclusively used. After chest tube placement, CT was used to confirm successful placement and function. For both ultrasound- and CT-guided procedures, chest tubes were then attached to a water seal 3-chamber evacuation device, with suction as
Volume 30 ▪ Number 11 ▪ November ▪ 2019
required. Subsequent chest tube management was in conjunction with the performing interventionist and the referring service, which included cardiovascular, thoracic, and vascular surgery, heart/lung transplant, cardiology, internal medicine, and emergency medicine. In this series, no patient had the chest tube placed by an open surgical cutdown technique.
Data Collection and Analysis The patient’s electronic medical record was reviewed for bleeding complications after the chest tube placement for a minimum of 7 days. Bleeding complications were defined and gradated using the Society of Interventional Radiology classification system for complications by outcome for major complications (10). Minor complications, including need for analgesia, asymptomatic bleeding seen on postprocedural imaging, minimal intrapleural hemorrhage, and/ or hemoptysis, often have limited clinical significance and are not accurately recorded in the medical record. For this reason, such minor complications were not included as an endpoint in this retrospective analysis. Additional data collected as a surrogate marker of bleeding included preprocedural hemoglobin and the post-procedural hemoglobin nadir occurring within 7 days after the procedure. Clinical success was defined as whether the chest tube adequately resolved the indicated condition without additional radiological or surgical procedure. Summary statistics for patient demographics, clinical characteristics, and complications were reported as either continuous variables (mean, median, range, and standard deviation) or categorical variables (number and/or percentage). JMP software (version 14; SAS Institute Inc, Cary, North Carolina) was used for statistical analysis.
RESULTS Forty-nine percutaneous chest tubes were placed in 45 patients. CT guidance was used for 27 (55%) procedures; ultrasound guidance was used for 22 (45%) procedures. Mean INR was 2.1 (range, 1.7–3). Twenty-one (43%) procedures were performed on patients with an INR between 1.7 and 1.9, 20 (41%) procedures with an INR between 2.0 and 2.4, and 8 (16%) procedures with an INR between 2.5 and 3.0. Two procedures were performed on patients who were on concomitant clopidogrel antiplatelet therapy at time of chest tube placement. The median chest tube size placed was 10 Fr (range, 8–14 Fr), occurring in 27 (55%) procedures. No major hemorrhagic complications were identified in the 49 chest tube procedures performed. Specifically, no patients required transfusion, angiography, or surgery as directly attributable to the chest tube placement procedure. Procedural laboratory data are displayed in Table 2. Paired t-test comparing the pre-procedural and postprocedural hemoglobin nadir found a significant change in
1767
Table 2. Procedural Data Number of catheters placed Image guidance
49 27 (55%) ¼ CT guided 22 (45%) ¼ Ultrasound guided
Size of chest catheter placed
8 Fr ¼ 19 (39%) 10 Fr ¼ 27 (55%) 12 Fr ¼ 1 (2%) 14 Fr ¼ 2 (4%)
Pre-procedural hemoglobin (g/dL) mean
9.6 (range, 6.7–13.4; SD ¼ 1.3)
Post-procedural hemoglobin (g/dL) average (lowest in 7 days after tube placement)
8.93 (range, 5–11.6; SD ¼ 1.4)
Mean decrease in hemoglobin (g/dL)
0.9 (range, 0–3.8; SD ¼ 0.8)
SD ¼ standard deviation.
hemoglobin after the procedure (P < .0001), with mean decrease of 0.9 g/dL within the first week after the procedure. Linear regression comparing chest tube size and post-procedural hemoglobin change found a significant correlation (P ¼ .0269). Linear regression comparing INR versus post-procedural change in hemoglobin, however, did not show a significant correlation (P ¼ .46). Thirty-nine (80%) tubes were considered clinically successful; 10 (20%) chest tubes were considered clinically unsuccessful. Seven (14%) patients with a complex pleural effusion/empyema required a subsequent surgical procedure for decortication.
DISCUSSION To date, the incidence of major hemorrhagic complications after ultrasound- or CT-guided chest tube placement in the setting of an elevated INR has been poorly defined. Patel et al (5), in a review of over 1000 ultrasound-guided thoracentesis, found no hemorrhagic complications in a subset of 32 patients with an INR over 3.0. In an analogous study of 640 joint injection and arthrocentesis procedures in patients on chronic warfarin therapy, no significant difference was found in hemorrhagic complications in patients with INR 2.0 or greater versus those patients in whom warfarin was stopped 3–5 days before the procedure. An elevated INR can be due to intended medical therapy with vitamin K antagonists, such as warfarin, or due to underlying systemic disease, including sepsis or chronic liver disease. It is standard practice to discontinue vitamin K antagonists 5 days prior to an invasive procedure (11,12). Unfortunately, there will remain select elective or emergent patients in whom such abstinence will not be possible. Current guidelines dictate the need for correction of underlying coagulopathy prior to chest tube placement (4,13). Unfortunately, such management algorithms have been predicated on very limited evidence, extrapolated from
1768 ▪ Percutaneous Chest Tube Placement in Patients with an Elevated INR
procedures considered to be of similar bleeding risk (14). In the correction of coagulopathy, the proceduralist needs to balance the risk of bleeding with not only the benefit of the chest tube placement but also the reversal of coagulopathy. Such reversal may include transfusion reaction and myocardial/cerebrovascular events, with specific risk balanced against the underlying indication for anticoagulation (6,15,16). It was previously demonstrated that the incidence of hemorrhage was actually greater in those patients undergoing corrective transfusion prior to thoracentesis compared to similar, high-risk patients who did not receive such transfusion (8). The current study showed the relative safety of imageguided chest tube placement in patients presumed to be at high risk for bleeding complications. Although no major bleeding complications were observed, a weak correlation was seen between increasing chest tube size and postprocedural hemoglobin decrease. Allowing for the relatively small number of high-risk patients, which is insufficient to show definitive safety, the current study showed the risk of bleeding to be much lower than anticipated to date. Such evidence will help guide proceduralists in balancing risk and benefit for such select patients and aid in the development of future management algorithms. This study had limitations, the first being its retrospective nature with a relatively small heterogeneous population size with no hemorrhagic events observed. Second, the patient sample size was relatively small, and additional larger studies are needed to more confidently define the safety of this procedure in high-risk patients. Major hemorrhagic complications are uncommon after image-guided percutaneous chest tube placement in patients at increased risk for hemorrhage due to an elevated INR. Further studies to confirm the safety of such procedures would be of value given the significant time delay and cost of reversing anticoagulation.
Navin et al ▪ JVIR
REFERENCES 1. Munnell ER. Thoracic drainage. Ann Thorc Surg 1997; 63:1497–1502. 2. Davies HE, Merchant S, McGown A. A study of the complications of small bore “Seldinger” intercostal chest drains. Respirology 2008; 13:603–607. 3. Horsley A, Jones L, White J, Henry M. Efficacy and complications of small-bore, wire-guided chest drains. Chest 2006; 130:1857–1863. 4. Havelock T, Teoh R, Laws D, Gleeson F, Group BTS Pleural Disease Guideline Group. Pleural procedures and thoracic ultrasound: British Thoracic Society Pleural Disease Guideline 2010. Thorax 2010; 65(Suppl 2):ii61–ii76. 5. Patel MD, Joshi SD. Abnormal preprocedural international normalized ratio and platelet counts are not associated with increased bleeding complications after ultrasound-guided thoracentesis. AJR Am J Roentgenol 2011; 197:W164–W–168. 6. Sibon I, Orgogozo JM. Antiplatelet drug discontinuation is a risk factor for ischemic stroke. Neurology 2004; 62:1187–1189. 7. Biondi-Zoccai GG, Lotrionte M, Agostoni P, et al. A systematic review and meta-analysis on the hazards of discontinuing or not adhering to aspirin among 50,279 patients at risk for coronary artery disease. Eur Heart J 2006; 27:2667–2674. 8. Hibbert RM, Atwell TD, Lekah A, et al. Safety of ultrasound-guided thoracentesis in patients with abnormal preprocedural coagulation parameters. Chest 2013; 144:456–463. 9. Puchalski JT, Argento AC, Murphy TE, Araujo KL, Pisani MA. The safety of thoracentesis in patients with uncorrected bleeding risk. Ann Am Thorac Soc 2013; 10:336–341. 10. Sacks D, McClenny TE, Cardella JF, Lewis CA. Society of Interventional Radiology clinical practice guidelines. J Vasc Interv Radiol 2003; 14: S199–S202. 11. Douketis JD, Spyropoulos AC, Spencer FA, et al. Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians EvidenceBased Clinical Practice Guidelines. Chest 2012; 141:e326S–e350S. 12. Baron TH, Kamath PS, McBane RD. Management of antithrombotic therapy in patients undergoing invasive procedures. N Engl J Med 2013; 368:2113–2124. 13. Malloy PC, Grassi CJ, Kundu S, et al. Consensus guidelines for periprocedural management of coagulation status and hemostasis risk in percutaneous image-guided interventions. J Vasc Interv Radiol 2009; 20:S240–S249. 14. Holbrook A, Schulman S, Witt DM, et al. Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians EvidenceBased Clinical Practice Guidelines. Chest 2012; 141:e152S–e184S. 15. Webert KE, Blajchman MA. Transfusion-related acute lung injury. Curr Opin Hematol 2005; 12:480–487. 16. Collet JP, Himbet F, Steg PG. Myocardial infarction after aspirin cessation in stable coronary artery disease patients. Int J Cardiol 2000; 76:257–258.
Periprocedural Major Bleeding Risk of Image-Guided Percutaneous Chest Tube Placement in Patients with an Elevated International Normalized Ratio Patrick. J. Navin, MBBChBAO, Mariah L. White, MD, Francis C. Nichols, MD, Darlene R. Nelson, MD, John J. Mullon, MD, Jennifer S. McDonald, PhD, Thomas D. Atwell, MD, and Michael R. Moynagh, MBBChBAO, MRCSI, FFRCSI ABSTRACT Purpose: To evaluate the incidence of major hemorrhage after image-guided percutaneous chest tube placement in patients with an abnormal international normalized ratio (INR) measured before the procedure. Materials and Methods: Between January 2013 and September 2017, 49 image-guided percutaneous chest tubes were placed in 45 adult patients who had an elevated INR of greater than 1.6. Data collected included routine serum pre-procedure coagulation studies, indication for chest tube placement, insertion technique, size of chest tube, and presence of complications after drain placement. Major bleeding complications were defined using the Society of Interventional Radiology classification system. Results: Mean patient age was 62 years (range, 22–94 years), with median American Society of Anesthesiologists score of 4. Mean INR was 2.1 (range, 1.7–3), with 21 (43%) procedures with an INR between 1.7 and 1.9, 20 (41%) procedures with an INR between 2.0 and 2.4, and 8 (16%) procedures with an INR between 2.5 and 3.0. Computed tomography guidance was used for 27 (55%) procedures; ultrasound guidance was used for 22 (45%) procedures. Median size of chest tube was 10 Fr (range, 8–14 Fr) used in 27 (55%) procedures. No major bleeding complications were observed. There was a small, significant decrease in mean hemoglobin after the procedure (mean ¼ 0.9g/dL; P < .0001), which correlated to increasing chest tube size (P ¼ .0269). Conclusions: No major bleeding complications were observed after image-guided percutaneous chest tube placement in patients with an elevated INR. Major bleeding complications in these patients may be safer than initially considered, and this study encourages the conduct of larger trials for further evaluation.
ABBREVIATION INR ¼ international normalized ratio
Percutaneous image-guided small bore chest tube (chest pleural catheter) placement is a commonly performed procedure for the treatment of pneumothorax and pleural
From the Departments of Radiology (P.J.N., M.L.W., J.S.M., T.D.A., M.R.M.), General Thoracic Surgery (F.C.N.), and Pulmonary and Critical Care Medicine (D.R.N., J.J.M.), Mayo Clinic, 200 First Street SW, Rochester, MN, 55905. Received June 22, 2018; final revision received July 1, 2019; accepted July 2, 2019. Address correspondence to M.R.M.; E-mail: moynagh.michael@ mayo.edu None of the authors have identified a conflict of interest. © SIR, 2019 J Vasc Interv Radiol 2019; 30:1765–1768 https://doi.org/10.1016/j.jvir.2019.07.002
effusions, with over 1 million placed annually (1). Minor bleeding rates have been reported between 1% and 2% for ultrasound-guided chest tube placement with normal coagulation profiles (2,3). Prior management guidelines have considered chest tube placement to be a procedure of moderate risk for bleeding, with a recommendation to correct underlying coagulopathy prior to intervention (4,5). Although helpful, these guidelines have lacked sufficient evidence to support such management and may even place patients at risk when reversing clinically indicated anticoagulation (6,7). Evidence is available to support the safety of thoracentesis in patients with abnormal serum screening studies (5,8,9). No studies are available evaluating the same bleeding risk related to percutaneous chest tube placement in such potentially high-risk patients.
1766 ▪ Percutaneous Chest Tube Placement in Patients with an Elevated INR
The purpose of the current study was to evaluate the incidence of major hemorrhage after image-guided percutaneous chest tube placement at a single institution in adult patients with a suspected increased risk of bleeding due to abnormal pre-procedural international normalized ratio (INR) coagulation profile.
Table 1. Demographics and Procedural Details N Male/Female
49 catheters placed in 45 patients 26/19
Age
Mean, 62 years (range, 22–94)
ASA score
Median, 4 (range, 3–5)
Indications for tube
Pneumothorax ¼ 20 (41%) Pleural effusion ¼ 11 (22%) Empyema ¼ 12 (24%) Hydro-pneumothorax ¼ 6 (12%)
Indication for elevated INR >1.6
Cardiac valve prosthesis ¼ 26 (53%) Atrial fibrillation ¼ 10 (21%) LVAD ¼ 5 (10%) Liver disease ¼ 4 (8%) Pulmonary embolism ¼ 3 (6%) Sepsis ¼ 1 (2%)
Comorbidities
Perioperative period after CABG, prosthetic valve placement, heart transplant, pulmonary lobectomy, LVAD placement, thoracic aortic aneurysm repair, extracardiac fontan, Ivor Lewis esophagectomy, and pacemaker placement. Severe heart failure, malignant effusion, immunosuppression from solid organ transplant, chemotherapy, AML, severe sepsis, pneumonia, and hemorrhagic pancreatitis
MATERIALS AND METHODS This single-center retrospective study was approved by the local institutional review board and is compliant with the Health Insurance Portability and Accountability Act. Based on billing codes, a review of institutional electronic medical records identified 869 consecutive adult patients aged 18 years or older who underwent either ultrasound- or computed tomography (CT)-guided percutaneous chest tube placement between January 2013 and July 2017. Patients were included in the final study cohort if they had an INR greater than 1.6 at the time of the procedure. Threshold laboratory values were chosen based on protocols at the performing institution for invasive procedures. Patients were excluded if they had undergone preprocedural corrective transfusion with fresh frozen plasma, or similar product, with laboratory confirmation of INR normalization (INR <1.6). Patients were included if they had failed attempted INR correction, with the INR remaining greater than 1.6 on a repeat laboratory draw performed in the interim between transfusion and procedure. In these cases, the patient’s lowest INR prior to the procedure was used for analysis. Patients were excluded if they had undergone pre-procedural corrective transfusion but had not had a subsequent INR rechecked in the interim between transfusion and chest tube placement. All procedures were performed in patients with a serum platelet count greater than 50 x 109/L. Indication for corrective transfusion was a multidisciplinary decision between the ordering clinical team and the proceduralist and was primarily based on the urgency of the procedure and indication for anticoagulation. Additional exclusion criteria included patients who specifically declined authorization for research. The final study cohort included 45 patients who underwent 49 percutaneous chest tube placements during the study period. Three patients were excluded who had their charts labeled as not authorized for research. Mean patient age was 62 years (range, 22–94 years), with median American Society of Anesthesiologists score of 4 (range, 3–5). Forty-three (88%) procedures were performed in patients without attempted INR correction. Six (12%) procedures were performed in patients who had failed attempted INR correction. The most common indication for chest tube placement was pneumothorax in 20 (41%) patients, followed by pleural effusion compromising respiratory status in 11 (22%) patients, empyema in 12 (24%) patients, and hydro-pneumothorax in 6 (12%) patients. Additional demographics are outlined in Table 1.
Navin et al ▪ JVIR
AML ¼ acute myeloid leukemia; ASA ¼ American Society of Anesthesiologists; CABG ¼ coronary artery bypass graft; INR ¼ international normalized ratio; LVAD ¼ left ventricular assist device.
Chest Tube Placement Technique Ultrasound-guided procedures were performed by either an interventional radiologist or a pulmonologist, with CTguided procedures performed by an interventional radiologist (median years of experience, 9; range, 1–25 years). Decision for CT versus ultrasound guidance was at the discretion of the interventional radiologist, based primarily on indication for chest tube, patient comorbidities, and morphology. Selection of tube size was based on clinical indication and operator preference. There was no specific change in technique to mitigate the potential risk of bleeding. For each procedure, the patient was prepared and draped in a sterile fashion, and 1% lidocaine was used for local anesthetic, typically using a 25-gauge needle. A small skin incision was made at the discretion of the interventionist. Ultrasound procedures were performed with 2 separate techniques based on operator preference. Ultrasound-guided cases employed a trocar technique; alternatively, a Seldinger technique was used. Procedures performed under CT guidance differed in that a Seldinger technique was exclusively used. After chest tube placement, CT was used to confirm successful placement and function. For both ultrasound- and CT-guided procedures, chest tubes were then attached to a water seal 3-chamber evacuation device, with suction as
Volume 30 ▪ Number 11 ▪ November ▪ 2019
required. Subsequent chest tube management was in conjunction with the performing interventionist and the referring service, which included cardiovascular, thoracic, and vascular surgery, heart/lung transplant, cardiology, internal medicine, and emergency medicine. In this series, no patient had the chest tube placed by an open surgical cutdown technique.
Data Collection and Analysis The patient’s electronic medical record was reviewed for bleeding complications after the chest tube placement for a minimum of 7 days. Bleeding complications were defined and gradated using the Society of Interventional Radiology classification system for complications by outcome for major complications (10). Minor complications, including need for analgesia, asymptomatic bleeding seen on postprocedural imaging, minimal intrapleural hemorrhage, and/ or hemoptysis, often have limited clinical significance and are not accurately recorded in the medical record. For this reason, such minor complications were not included as an endpoint in this retrospective analysis. Additional data collected as a surrogate marker of bleeding included preprocedural hemoglobin and the post-procedural hemoglobin nadir occurring within 7 days after the procedure. Clinical success was defined as whether the chest tube adequately resolved the indicated condition without additional radiological or surgical procedure. Summary statistics for patient demographics, clinical characteristics, and complications were reported as either continuous variables (mean, median, range, and standard deviation) or categorical variables (number and/or percentage). JMP software (version 14; SAS Institute Inc, Cary, North Carolina) was used for statistical analysis.
RESULTS Forty-nine percutaneous chest tubes were placed in 45 patients. CT guidance was used for 27 (55%) procedures; ultrasound guidance was used for 22 (45%) procedures. Mean INR was 2.1 (range, 1.7–3). Twenty-one (43%) procedures were performed on patients with an INR between 1.7 and 1.9, 20 (41%) procedures with an INR between 2.0 and 2.4, and 8 (16%) procedures with an INR between 2.5 and 3.0. Two procedures were performed on patients who were on concomitant clopidogrel antiplatelet therapy at time of chest tube placement. The median chest tube size placed was 10 Fr (range, 8–14 Fr), occurring in 27 (55%) procedures. No major hemorrhagic complications were identified in the 49 chest tube procedures performed. Specifically, no patients required transfusion, angiography, or surgery as directly attributable to the chest tube placement procedure. Procedural laboratory data are displayed in Table 2. Paired t-test comparing the pre-procedural and postprocedural hemoglobin nadir found a significant change in
1767
Table 2. Procedural Data Number of catheters placed Image guidance
49 27 (55%) ¼ CT guided 22 (45%) ¼ Ultrasound guided
Size of chest catheter placed
8 Fr ¼ 19 (39%) 10 Fr ¼ 27 (55%) 12 Fr ¼ 1 (2%) 14 Fr ¼ 2 (4%)
Pre-procedural hemoglobin (g/dL) mean
9.6 (range, 6.7–13.4; SD ¼ 1.3)
Post-procedural hemoglobin (g/dL) average (lowest in 7 days after tube placement)
8.93 (range, 5–11.6; SD ¼ 1.4)
Mean decrease in hemoglobin (g/dL)
0.9 (range, 0–3.8; SD ¼ 0.8)
SD ¼ standard deviation.
hemoglobin after the procedure (P < .0001), with mean decrease of 0.9 g/dL within the first week after the procedure. Linear regression comparing chest tube size and post-procedural hemoglobin change found a significant correlation (P ¼ .0269). Linear regression comparing INR versus post-procedural change in hemoglobin, however, did not show a significant correlation (P ¼ .46). Thirty-nine (80%) tubes were considered clinically successful; 10 (20%) chest tubes were considered clinically unsuccessful. Seven (14%) patients with a complex pleural effusion/empyema required a subsequent surgical procedure for decortication.
DISCUSSION To date, the incidence of major hemorrhagic complications after ultrasound- or CT-guided chest tube placement in the setting of an elevated INR has been poorly defined. Patel et al (5), in a review of over 1000 ultrasound-guided thoracentesis, found no hemorrhagic complications in a subset of 32 patients with an INR over 3.0. In an analogous study of 640 joint injection and arthrocentesis procedures in patients on chronic warfarin therapy, no significant difference was found in hemorrhagic complications in patients with INR 2.0 or greater versus those patients in whom warfarin was stopped 3–5 days before the procedure. An elevated INR can be due to intended medical therapy with vitamin K antagonists, such as warfarin, or due to underlying systemic disease, including sepsis or chronic liver disease. It is standard practice to discontinue vitamin K antagonists 5 days prior to an invasive procedure (11,12). Unfortunately, there will remain select elective or emergent patients in whom such abstinence will not be possible. Current guidelines dictate the need for correction of underlying coagulopathy prior to chest tube placement (4,13). Unfortunately, such management algorithms have been predicated on very limited evidence, extrapolated from
1768 ▪ Percutaneous Chest Tube Placement in Patients with an Elevated INR
procedures considered to be of similar bleeding risk (14). In the correction of coagulopathy, the proceduralist needs to balance the risk of bleeding with not only the benefit of the chest tube placement but also the reversal of coagulopathy. Such reversal may include transfusion reaction and myocardial/cerebrovascular events, with specific risk balanced against the underlying indication for anticoagulation (6,15,16). It was previously demonstrated that the incidence of hemorrhage was actually greater in those patients undergoing corrective transfusion prior to thoracentesis compared to similar, high-risk patients who did not receive such transfusion (8). The current study showed the relative safety of imageguided chest tube placement in patients presumed to be at high risk for bleeding complications. Although no major bleeding complications were observed, a weak correlation was seen between increasing chest tube size and postprocedural hemoglobin decrease. Allowing for the relatively small number of high-risk patients, which is insufficient to show definitive safety, the current study showed the risk of bleeding to be much lower than anticipated to date. Such evidence will help guide proceduralists in balancing risk and benefit for such select patients and aid in the development of future management algorithms. This study had limitations, the first being its retrospective nature with a relatively small heterogeneous population size with no hemorrhagic events observed. Second, the patient sample size was relatively small, and additional larger studies are needed to more confidently define the safety of this procedure in high-risk patients. Major hemorrhagic complications are uncommon after image-guided percutaneous chest tube placement in patients at increased risk for hemorrhage due to an elevated INR. Further studies to confirm the safety of such procedures would be of value given the significant time delay and cost of reversing anticoagulation.
Navin et al ▪ JVIR
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