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Point-of-Care Ultrasound for Hospitalists: A Position Statement of the Society of Hospital Medicine

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Many hospitalists incorporate point-of-care ultrasound (POCUS) into their daily practice because it adds value to their bedside evaluation of patients. However, standards for training and assessing hospitalists in POCUS have not yet been established. Other acute care specialties, including emergency medicine and critical care medicine, have already incorporated POCUS into their graduate medical education training programs, but most internal medicine residency programs are only beginning to provide POCUS training.¹

Several features distinguish POCUS from comprehensive ultrasound examinations. First, POCUS is designed to answer focused questions, whereas comprehensive ultrasound examinations evaluate all organs in an anatomical region; for example, an abdominal POCUS exam may evaluate only for presence or absence of intraperitoneal free fluid, whereas a comprehensive examination of the right upper quadrant will evaluate the liver, gallbladder, and biliary ducts. Second, POCUS examinations are generally performed by the same clinician who generates the relevant clinical question to answer with POCUS and ultimately integrates the findings into the patient’s care.² By contrast, comprehensive ultrasound examinations involve multiple providers and steps: a clinician generates a relevant clinical question and requests an ultrasound examination that is acquired by a sonographer, interpreted by a radiologist, and reported back to the requesting clinician. Third, POCUS is often used to evaluate multiple body systems. For example, to evaluate a patient with undifferentiated hypotension, a multisystem POCUS examination of the heart, inferior vena cava, lungs, abdomen, and lower extremity veins is typically performed. Finally, POCUS examinations can be performed serially to investigate changes in clinical status or evaluate response to therapy, such as monitoring the heart, lungs, and inferior vena cava during fluid resuscitation.

The purpose of this position statement is to inform a broad audience about how hospitalists are using diagnostic and procedural applications of POCUS. This position statement does not mandate that hospitalists use POCUS. Rather, it is intended to provide guidance on the safe and effective use of POCUS by the hospitalists who use it and the administrators who oversee its use. We discuss POCUS (1) applications, (2) training, (3) assessments, and (4) program management. This position statement was reviewed and approved by the Society of Hospital Medicine (SHM) Executive Committee in March 2018.

APPLICATIONS

Common diagnostic and procedural applications of POCUS used by hospitalists are listed in Table 1. Selected evidence supporting the use of these applications is described in the supplementary online content (Appendices 1–8 available at http://journalofhospitalmedicine.com) and SHM position statements on specific ultrasound-guided bedside procedures.^3,4 Additional applications not listed in Table 1 that may be performed by some hospitalists include assessment of the eyes, stomach, bowels, ovaries, pregnancy, and testicles, as well as performance of regional anesthesia. Moreover, hospitalists caring for pediatric and adolescent patients may use additional applications besides those listed here. Currently, many hospitalists already perform more complex and sophisticated POCUS examinations than those listed in Table 1. The scope of POCUS use by hospitalists continues to expand, and this position statement should not restrict that expansion.

As outlined in our earlier position statements,^3,4 ultrasound guidance lowers complication rates and increases success rates of invasive bedside procedures. Diagnostic POCUS can guide clinical decision making prior to bedside procedures. For instance, hospitalists may use POCUS to assess the size and character of a pleural effusion to help determine the most appropriate management strategy: observation, medical treatment, thoracentesis, chest tube placement, or surgical therapy. Furthermore, diagnostic POCUS can be used to rapidly assess for immediate postprocedural complications, such as pneumothorax, or if the patient develops new symptoms.

TRAINING

Basic Knowledge

Basic knowledge includes fundamentals of ultrasound physics; safety;⁴ anatomy; physiology; and device operation, including maintenance and cleaning. Basic knowledge can be taught by multiple methods, including live or recorded lectures, online modules, or directed readings.

Image Acquisition

Training should occur across multiple types of patients (eg, obese, cachectic, postsurgical) and clinical settings (eg, intensive care unit, general medicine wards, emergency department) when available. Training is largely hands-on because the relevant skills involve integration of 3D anatomy with spatial manipulation, hand-eye coordination, and fine motor movements. Virtual reality ultrasound simulators may accelerate mastery, particularly for cardiac image acquisition, and expose learners to standardized sets of pathologic findings. Real-time bedside feedback on image acquisition is ideal because understanding how ultrasound probe manipulation affects the images acquired is essential to learning.

Image Interpretation

Training in image interpretation relies on visual pattern recognition of normal and abnormal findings. Therefore, the normal to abnormal spectrum should be broad, and learners should maintain a log of what abnormalities have been identified. Giving real-time feedback at the bedside is ideal because of the connection between image acquisition and interpretation. Image interpretation can be taught through didactic sessions, image review sessions, or review of teaching files with annotated images.

Clinical Integration

Learners must interpret and integrate image findings with other clinical data considering the image quality, patient characteristics, and changing physiology. Clinical integration should be taught by instructors that share similar clinical knowledge as learners. Although sonographers are well suited to teach image acquisition, they should not be the sole instructors to teach hospitalists how to integrate ultrasound findings in clinical decision making. Likewise, emphasis should be placed on the appropriate use of POCUS within a provider’s skill set. Learners must appreciate the clinical significance of POCUS findings, including recognition of incidental findings that may require further workup. Supplemental training in clinical integration can occur through didactics that include complex patient scenarios.

Pathways

Clinical competency can be achieved with training adherent to five criteria. First, the training environment should be similar to where the trainee will practice. Second, training and feedback should occur in real time. Third, specific applications should be taught rather than broad training in “hospitalist POCUS.” Each application requires unique skills and knowledge, including image acquisition pitfalls and artifacts. Fourth, clinical competence must be achieved and demonstrated; it is not necessarily gained through experience. Fifth, once competency is achieved, continued education and feedback are necessary to ensure it is maintained.

Residency-based POCUS training pathways can best fulfill these criteria. They may eventually become commonplace, but until then alternative pathways must exist for hospitalist providers who are already in practice. There are three important attributes of such pathways. First, administrators’ expectations about learners’ clinical productivity must be realistically, but only temporarily, relaxed; otherwise, competing demands on time will likely overwhelm learners and subvert training. Second, training should begin through a local or national hands-on training program. The SHM POCUS certificate program consolidates training for common diagnostic POCUS applications for hospitalists.⁶ Other medical societies offer training for their respective clinical specialties.⁷ Third, once basic POCUS training has begun, longitudinal training should continue ideally with a local hospitalist POCUS expert.

In some settings, a subgroup of hospitalists may not desire, or be able to achieve, competency in the manual skills of POCUS image acquisition. Nevertheless, hospitalists may still find value in understanding POCUS nomenclature, image pattern recognition, and the evidence and pitfalls behind clinical integration of specific POCUS findings. This subset of POCUS skills allows hospitalists to communicate effectively with and understand the clinical decisions made by their colleagues who are competent in POCUS use.

The minimal skills a hospitalist should possess to serve as a POCUS trainer include proficiency of basic knowledge, image acquisition, image interpretation, and clinical integration of the POCUS applications being taught; effectiveness as a hands-on instructor to teach image acquisition skills; and an in-depth understanding of common POCUS pitfalls and limitations.

ASSESSMENTS

Assessment methods for POCUS can include the following: knowledge-based questions, image acquisition using task-specific checklists on human or simulation models, image interpretation using a series of videos or still images with normal and abnormal findings, clinical integration using “next best step” in a multiple choice format with POCUS images, and simulation-based clinical scenarios. Assessment methods should be aligned with local availability of resources and trainers.

Basic Knowledge

Basic knowledge can be assessed via multiple choice questions assessing knowledge of ultrasound physics, image optimization, relevant anatomy, and limitations of POCUS imaging. Basic knowledge lies primarily in the cognitive domain and does not assess manual skills.

Image Acquisition

Image acquisition can be assessed by observation and rating of image quality. Where resources allow, assessment of image acquisition is likely best done through a combination of developing an image portfolio with a minimum number of high quality images, plus direct observation of image acquisition by an expert. Various programs have utilized minimum numbers of images acquired to help define competence with image acquisition skills.^6–8 Although minimums may be a necessary step to gain competence, using them as a sole means to determine competence does not account for variable learning curves.⁹ As with other manual skills in hospital medicine, such as ultrasound-guided bedside procedures, minimum numbers are best used as a starting point for assessments.^3,10 In this regard, portfolio development with meticulous attention to the gain, depth, and proper tomographic plane of images can monitor a hospitalist’s progress toward competence by providing objective assessments and feedback. Simulation may also be used as it allows assessment of image acquisition skills and an opportunity to provide real-time feedback, similar to direct observation but without actual patients.

Image Interpretation

Image interpretation is best assessed by an expert observing the learner at bedside; however, when bedside assessment is not possible, image interpretation skills may be assessed using multiple choice or free text interpretation of archived ultrasound images with normal and abnormal findings. This is often incorporated into the portfolio development portion of a training program, as learners can submit their image interpretation along with the video clip. Both normal and abnormal images can be used to assess anatomic recognition and interpretation. Emphasis should be placed on determining when an image is suboptimal for diagnosis (eg, incomplete exam or poor-quality images). Quality assurance programs should incorporate structured feedback sessions.

Clinical Integration

Assessment of clinical integration can be completed through case scenarios that assess knowledge, interpretation of images, and integration of findings into clinical decision making, which is often delivered via a computer-based assessment. Assessments should combine specific POCUS applications to evaluate common clinical problems in hospital medicine, such as undifferentiated hypotension and dyspnea. High-fidelity simulators can be used to blend clinical case scenarios with image acquisition, image interpretation, and clinical integration. When feasible, comprehensive feedback on how providers acquire, interpret, and apply ultrasound at the bedside is likely the best mechanism to assess clinical integration. This process can be done with a hospitalist’s own patients.

General Assessment

A general assessment that includes a summative knowledge and hands-on skills assessment using task-specific checklists can be performed upon completion of training. A high-fidelity simulator with dynamic or virtual anatomy can provide reproducible standardized assessments with variation in the type and difficulty of cases. When available, we encourage the use of dynamic assessments on actual patients that have both normal and abnormal ultrasound findings because simulated patient scenarios have limitations, even with the use of high-fidelity simulators. Programs are recommended to use formative and summative assessments for evaluation. Quantitative scoring systems using checklists are likely the best framework.^11,12

CERTIFICATES AND CERTIFICATION

A certificate of completion is proof of a provider’s participation in an educational activity; it does not equate with competency, though it may be a step toward it. Most POCUS training workshops and short courses provide certificates of completion. Certification of competency is an attestation of a hospitalist’s basic competence within a defined scope of practice (Table 2).¹³ However, without longitudinal supervision and feedback, skills can decay; therefore, we recommend a longitudinal training program that provides mentored feedback and incorporates periodic competency assessments. At present, no national board certification in POCUS is available to grant external certification of competency for hospitalists.

External Certificate

Certificates of completion can be external through a national organization. An external certificate of completion designed for hospitalists includes the POCUS Certificate of Completion offered by SHM in collaboration with CHEST.⁶ This certificate program provides regional training options and longitudinal portfolio development. Other external certificates are also available to hospitalists.^7,14,15

Most hospitalists are boarded by the American Board of Internal Medicine or the American Board of Family Medicine. These boards do not yet include certification of competency in POCUS. Other specialty boards, such as emergency medicine, include competency in POCUS. For emergency medicine, completion of an accredited residency training program and certification by the national board includes POCUS competency.

Internal Certificate

There are a few examples of successful local institutional programs that have provided internal certificates of competency.^12,14 Competency assessments require significant resources including investment by both faculty and learners. Ongoing evaluation of competency should be based on quality assurance processes.

Credentialing and Privileging

The American Medical Association (AMA) House of Delegates in 1999 passed a resolution (AMA HR. 802) recommending hospitals follow specialty-specific guidelines for privileging decisions related to POCUS use.¹⁷ The resolution included a statement that, “ultrasound imaging is within the scope of practice of appropriately trained physicians.”

Some institutions have begun to rely on a combination of internal and external certificate programs to grant privileges to hospitalists.¹⁰ Although specific privileges for POCUS may not be required in some hospitals, some institutions may require certification of training and assessments prior to granting permission to use POCUS.

Hospitalist programs are encouraged to evaluate ongoing POCUS use by their providers after granting initial permission. If privileging is instituted by a hospital, hospitalists must play a significant role in determining the requirements for privileging and ongoing maintenance of skills.

Maintenance of Skills

All medical skills can decay with disuse, including those associated with POCUS.^12,18 Thus, POCUS users should continue using POCUS regularly in clinical practice and participate in POCUS continuing medical education activities, ideally with ongoing assessments. Maintenance of skills may be confirmed through routine participation in a quality assurance program.

PROGRAM MANAGEMENT

Use of POCUS in hospital medicine has unique considerations, and hospitalists should be integrally involved in decision making surrounding institutional POCUS program management. Appointing a dedicated POCUS director can help a program succeed.⁸

Equipment and Image Archiving

Several factors are important to consider when selecting an ultrasound machine: portability, screen size, and ease of use; integration with the electronic medical record and options for image archiving; manufacturer’s service plan, including technical and clinical support; and compliance with local infection control policies. The ability to easily archive and retrieve images is essential for quality assurance, continuing education, institutional quality improvement, documentation, and reimbursement. In certain scenarios, image archiving may not be possible (such as with personal handheld devices or in emergency situations) or necessary (such as with frequent serial examinations during fluid resuscitation). An image archive is ideally linked to reports, orders, and billing software.^10,19 If such linkages are not feasible, parallel external storage that complies with regulatory standards (ie, HIPAA compliance) may be suitable.²⁰

Documentation and Billing

Components of documentation include the indication and type of ultrasound examination performed, date and time of the examination, patient identifying information, name of provider(s) acquiring and interpreting the images, specific scanning protocols used, patient position, probe used, and findings. Documentation can occur through a standalone note or as part of another note, such as a progress note. Whenever possible, documentation should be timely to facilitate communication with other providers.

Billing is supported through the AMA Current Procedural Terminology codes for “focused” or “limited” ultrasound examinations (Appendix 9). The following three criteria must be satisfied for billing. First, images must be permanently stored. Specific requirements vary by insurance policy, though current practice suggests a minimum of one image demonstrating relevant anatomy and pathology for the ultrasound examination coded. For ultrasound-guided procedures that require needle insertion, images should be captured at the point of interest, and a procedure note should reflect that the needle was guided and visualized under ultrasound.²¹ Second, proper documentation must be entered in the medical record. Third, local institutional privileges for POCUS must be considered. Although privileges are not required to bill, some hospitals or payers may require them.

Quality Assurance

Published guidelines on quality assurance in POCUS are available from different specialty organizations, including emergency medicine, pediatric emergency medicine, critical care, anesthesiology, obstetrics, and cardiology.^8,22–28 Quality assurance is aimed at ensuring that physicians maintain basic competency in using POCUS to influence bedside decisions.

Quality assurance should be carried out by an individual or committee with expertise in POCUS. Multidisciplinary QA programs in which hospital medicine providers are working collaboratively with other POCUS providers have been demonstrated to be highly effective.¹⁰ Oversight includes ensuring that providers using POCUS are appropriately trained,^10,22,28 using the equipment correctly,^8,26,28 and documenting properly. Some programs have implemented mechanisms to review and provide feedback on image acquisition, interpretation, and clinical integration.^8,10 Other programs have compared POCUS findings with referral studies, such as comprehensive ultrasound examinations.

CONCLUSIONS

Practicing hospitalists must continue to collaborate with their institutions to build POCUS capabilities. In particular, they must work with their local privileging body to determine what credentials are required. The distinction between certificates of completion and certificates of competency, including whether those certificates are internal or external, is important in the credentialing process.

External certificates of competency are currently unavailable for most practicing hospitalists because ABIM certification does not include POCUS-related competencies. As internal medicine residency training programs begin to adopt POCUS training and certification into their educational curricula, we foresee a need to update the ABIM Policies and Procedures for Certification. Until then, we recommend that certificates of competency be defined and granted internally by local hospitalist groups.

Given the many advantages of POCUS over traditional tools, we anticipate its increasing implementation among hospitalists in the future. As with all medical technology, its role in clinical care should be continuously reexamined and redefined through health services research. Such information will be useful in developing practice guidelines, educational curricula, and training standards.

Acknowledgments

The authors would like to thank all members that participated in the discussion and finalization of this position statement during the Point-of-care Ultrasound Faculty Retreat at the 2018 Society of Hospital Medicine Annual Conference: Saaid Abdel-Ghani, Brandon Boesch, Joel Cho, Ria Dancel, Renee Dversdal, Ricardo Franco-Sadud, Benjamin Galen, Trevor P. Jensen, Mohit Jindal, Gordon Johnson, Linda M. Kurian, Gigi Liu, Charles M. LoPresti, Brian P. Lucas, Venkat Kalidindi, Benji Matthews, Anna Maw, Gregory Mints, Kreegan Reierson, Gerard Salame, Richard Schildhouse, Daniel Schnobrich, Nilam Soni, Kirk Spencer, Hiromizu Takahashi, David M. Tierney, Tanping Wong, and Toru Yamada.

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References

1. Schnobrich DJ, Mathews BK, Trappey BE, Muthyala BK, Olson APJ. Entrusting internal medicine residents to use point of care ultrasound: Towards improved assessment and supervision. Med Teach. 2018:1-6. doi:10.1080/0142159X.2018.1457210.
2. Soni NJ, Lucas BP. Diagnostic point-of-care ultrasound for hospitalists. J Hosp Med. 2015;10(2):120-124. doi:10.1002/jhm.2285.
3. Lucas BP, Tierney DM, Jensen TP, et al. Credentialing of hospitalists in ultrasound-guided bedside procedures: a position statement of the society of hospital medicine. J Hosp Med. 2018;13(2):117-125. doi:10.12788/jhm.2917.
4. Dancel R, Schnobrich D, Puri N, et al. Recommendations on the use of ultrasound guidance for adult thoracentesis: a position statement of the society of hospital medicine. J Hosp Med. 2018;13(2):126-135. doi:10.12788/jhm.2940.
5. National Council on Radiation Protection and Measurements, The Council. Implementation of the Principle of as Low as Reasonably Achievable (ALARA) for Medical and Dental Personnel.; 1990.
6. Society of Hospital Medicine. Point of Care Ultrasound course: https://www.hospitalmedicine.org/clinical-topics/ultrasonography-cert/. Accessed February 6, 2018.
7. Critical Care Ultrasonography Certificate of Completion Program. CHEST. American College of Chest Physicians. http://www.chestnet.org/Education/Advanced-Clinical-Training/Certificate-of-Completion-Program/Critical-Care-Ultrasonography. Accessed February 6, 2018.
8. American College of Emergency Physicians Policy Statement: Emergency Ultrasound Guidelines. 2016. https://www.acep.org/Clinical---Practice-Management/ACEP-Ultrasound-Guidelines/. Accessed February 6, 2018.
9. Blehar DJ, Barton B, Gaspari RJ. Learning curves in emergency ultrasound education. Acad Emerg Med. 2015;22(5):574-582. doi:10.1111/acem.12653.
10. Mathews BK, Zwank M. Hospital medicine point of care ultrasound credentialing: an example protocol. J Hosp Med. 2017;12(9):767-772. doi:10.12788/jhm.2809.
11. Barsuk JH, McGaghie WC, Cohen ER, Balachandran JS, Wayne DB. Use of simulation-based mastery learning to improve the quality of central venous catheter placement in a medical intensive care unit. J Hosp Med. 2009;4(7):397-403. doi:10.1002/jhm.468.
12. Mathews BK, Reierson K, Vuong K, et al. The design and evaluation of the Comprehensive Hospitalist Assessment and Mentorship with Portfolios (CHAMP) ultrasound program. J Hosp Med. 2018;13(8):544-550. doi:10.12788/jhm.2938.
13. Soni NJ, Tierney DM, Jensen TP, Lucas BP. Certification of point-of-care ultrasound competency. J Hosp Med. 2017;12(9):775-776. doi:10.12788/jhm.2812.
14. Ultrasound Certification for Physicians. Alliance for Physician Certification and Advancement. APCA. https://apca.org/. Accessed February 6, 2018.
15. National Board of Echocardiography, Inc. https://www.echoboards.org/EchoBoards/News/2019_Adult_Critical_Care_Echocardiography_Exam.aspx. Accessed June 18, 2018.
16. Tierney DM. Internal Medicine Bedside Ultrasound Program (IMBUS). Abbott Northwestern. http://imbus.anwresidency.com/index.html. Accessed February 6, 2018.
17. American Medical Association House of Delegates Resolution H-230.960: Privileging for Ultrasound Imaging. Resolution 802. Policy Finder Website. http://search0.ama-assn.org/search/pfonline. Published 1999. Accessed February 18, 2018.
18. Kelm D, Ratelle J, Azeem N, et al. Longitudinal ultrasound curriculum improves long-term retention among internal medicine residents. J Grad Med Educ. 2015;7(3):454-457. doi:10.4300/JGME-14-00284.1.
19. Flannigan MJ, Adhikari S. Point-of-care ultrasound work flow innovation: impact on documentation and billing. J Ultrasound Med. 2017;36(12):2467-2474. doi:10.1002/jum.14284.
20. Emergency Ultrasound: Workflow White Paper. https://www.acep.org/uploadedFiles/ACEP/memberCenter/SectionsofMembership/ultra/Workflow%20White%20Paper.pdf. Published 2013. Accessed February 18, 2018.
21. Ultrasound Coding and Reimbursement Document 2009. Emergency Ultrasound Section. American College of Emergency Physicians. http://emergencyultrasoundteaching.com/assets/2009_coding_update.pdf. Published 2009. Accessed February 18, 2018.
22. Mayo PH, Beaulieu Y, Doelken P, et al. American College of Chest Physicians/La Societe de Reanimation de Langue Francaise statement on competence in critical care ultrasonography. Chest. 2009;135(4):1050-1060. doi:10.1378/chest.08-2305.
23. Frankel HL, Kirkpatrick AW, Elbarbary M, et al. Guidelines for the appropriate use of bedside general and cardiac ultrasonography in the evaluation of critically ill patients-part I: general ultrasonography. Crit Care Med. 2015;43(11):2479-2502. doi:10.1097/ccm.0000000000001216.
24. Levitov A, Frankel HL, Blaivas M, et al. Guidelines for the appropriate use of bedside general and cardiac ultrasonography in the evaluation of critically ill patients-part ii: cardiac ultrasonography. Crit Care Med. 2016;44(6):1206-1227. doi:10.1097/ccm.0000000000001847.
25. ACR–ACOG–AIUM–SRU Practice Parameter for the Performance of Obstetrical Ultrasound. https://www.acr.org/-/media/ACR/Files/Practice-Parameters/us-ob.pdf. Published 2013. Accessed February 18, 2018.
26. AIUM practice guideline for documentation of an ultrasound examination. J Ultrasound Med. 2014;33(6):1098-1102. doi:10.7863/ultra.33.6.1098.
27. Marin JR, Lewiss RE. Point-of-care ultrasonography by pediatric emergency medicine physicians. Pediatrics. 2015;135(4):e1113-e1122. doi:10.1542/peds.2015-0343.
28. Spencer KT, Kimura BJ, Korcarz CE, Pellikka PA, Rahko PS, Siegel RJ. Focused cardiac ultrasound: recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr. 2013;26(6):567-581. doi:10.1016/j.echo.2013.04.001.

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¹Division of General & Hospital Medicine, The University of Texas Health San Antonio, San Antonio, Texas; ²Section of Hospital Medicine, South Texas Veterans Health Care System, San Antonio, Texas; ³Divisions of General Internal Medicine and Hospital Pediatrics, University of Minnesota, Minneapolis, Minnesota; ⁴Department of Hospital Medicine, HealthPartners Medical Group, Regions Hospital, St. Paul, Minnesota; ⁵Department of Medical Education, Abbott Northwestern Hospital, Minneapolis, Minnesota; ⁶Division of Hospital Medicine, Department of Medicine, University of California San Francisco, San Francisco, California; ⁷Division of Hospital Medicine, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina; ⁸Division of General Pediatrics and Adolescent Medicine, Department of Pediatrics, University of North Carolina, Chapel Hill, North Carolina; ⁹Department of Hospital Medicine, Kaiser Permanente San Francisco Medical Center, San Francisco, California; ¹⁰Division of Hospital Medicine, Oregon Health & Science University, Portland, Oregon; ¹¹Division of Hospital Medicine, Weill Cornell Medicine, New York, New York; ¹²Division of General Internal Medicine, Mayo Clinic, Rochester, Minnesota; ¹³Division of Hospital Medicine, Zucker School of Medicine at Hofstra Northwell, New Hyde Park, New York; ¹⁴Hospitalist Program, Division of General Internal Medicine, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland; ¹⁵Division of Hospital Medicine, University of California Davis, Davis, California; ¹⁶Division of Hospital Medicine, Alameda Health System-Highland Hospital, Oakland, California; ¹⁷Louis Stokes Cleveland Veterans Affairs Hospital, Cleveland, Ohio; ¹⁸Case Western Reserve University School of Medicine, Cleveland, Ohio; ¹⁹Division of Hospital Medicine, University of Miami, Miami, Florida; ²⁰Division of Hospital Medicine, Legacy Healthcare System, Portland, Oregon; ²¹Division of Hospital Medicine, University of Colorado, Aurora, Colorado; ²²Department of Medicine, University of Central Florida, Naples, Florida; ²³White River Junction VA Medical Center, White River Junction, Vermont; ²⁴Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire.

Funding

Nilam Soni: Department of Veterans Affairs, Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative Grant (HX002263-01A1). Brian P Lucas: Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development and Dartmouth SYNERGY, National Institutes of Health, National Center for Translational Science (UL1TR001086)

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APPLICATIONS

TRAINING

Basic Knowledge

Image Acquisition

Image Interpretation

Clinical Integration

Pathways

ASSESSMENTS

Basic Knowledge

Image Acquisition

Image Interpretation

Clinical Integration

General Assessment

CERTIFICATES AND CERTIFICATION

External Certificate

Internal Certificate

Credentialing and Privileging

Maintenance of Skills

PROGRAM MANAGEMENT

Equipment and Image Archiving

Documentation and Billing

Quality Assurance

CONCLUSIONS

Acknowledgments

APPLICATIONS

TRAINING

Basic Knowledge

Image Acquisition

Image Interpretation

Clinical Integration

Pathways

ASSESSMENTS

Basic Knowledge

Image Acquisition

Image Interpretation

Clinical Integration

General Assessment

CERTIFICATES AND CERTIFICATION

External Certificate

Internal Certificate

Credentialing and Privileging

Maintenance of Skills

PROGRAM MANAGEMENT

Equipment and Image Archiving

Documentation and Billing

Quality Assurance

CONCLUSIONS

Acknowledgments

References

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Published Online Only January 2, 2019. doi: 10.12788/jhm.3079

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Corresponding Author: Nilam J. Soni, MD MS; E-mail: sonin@uthscsa.edu; Telephone: 210-743-6030.

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Recommendations on the Use of Ultrasound Guidance for Adult Abdominal Paracentesis: A Position Statement of the Society of Hospital Medicine

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Author(s)

Joel Cho, MD RDMS RDCS

Trevor P. Jensen, MD MS

Kreegan Reierson, MD

Benji K. Mathews, MD

Anjali Bhagra, MD

Ricardo Franco-Sadud, MD

Loretta Grikis, MLS

Michael Mader, MS

Ria Dancel, MD

Brian P. Lucas, MD MS

Society of Hospital Medicine Point-of-care Ultrasound Task Force

Nilam J. Soni, MD, MS

Abdominal paracentesis is a common and increasingly performed procedure in the United States. According to Medicare Physician Supplier Procedure Summary Master Files, an estimated 150,000 paracenteses were performed on Medicare fee-for-service beneficiaries in 2008 alone; such a number represents more than a two-fold increase from the same service population in 1993.¹ This increasing trend was again noted by the Nationwide Inpatient Sample data, which identified a 10% increase in hospitalized patients with a diagnosis of cirrhosis receiving paracentesis from 2004 (50%) to 2012 (61%; P < .0001).²

Although these data demonstrate that paracentesis is being performed frequently, paracentesis may be underutilized in hospitalized cirrhotics with ascites. In addition, in-hospital mortality of cirrhotics with ascites is higher among those who do not undergo paracentesis than among those who do (9% vs 6%; P = .03).^3,4

While complications associated with paracentesis are rare, serious complications, including death, have been documented.^5-10 The most common serious complication of paracentesis is bleeding, although puncture of the bowel and other abdominal organs has also been observed. Over the past few decades, ultrasound has been increasingly used with paracentesis due to the ability of ultrasound to improve detection of ascites^11,12 and to avoid blood vessels^10,13-15 and bowels.¹⁶

Three-quarters of all paracenteses are currently performed by interventional radiologists.¹ However, paracenteses are often required off-hours,¹⁷ when interventional radiologists are less readily available. Weekend admissions have less frequent performance of early paracentesis than weekday admissions, and delaying paracentesis may increase mortality.^3,18 High proficiency in ultrasound-guided paracentesis is achievable by nonradiologists^19-28 with equal or better patient outcomes after appropriate training.²⁹

The purpose of this guideline is to review the literature and present evidence-based recommendations on the performance of ultrasound-guided paracentesis at the bedside by practicing hospitalists.

METHODS

Detailed methods are described in Appendix 1. The Society of Hospital Medicine (SHM) Point-of-care Ultrasound (POCUS) Task Force was assembled to carry out this guideline development project under the direction of the SHM Board of Directors, Director of Education, and Education Committee. All expert panel members were physicians or advanced-practice providers with expertise in POCUS. Expert panel members were divided into working group members, external peer reviewers, and a methodologist, and all Task Force members were required to disclose any potential conflicts of interests (Appendix 2). The literature search was conducted in two independent phases. The first phase included literature searches conducted by the five working group members themselves. Key clinical questions and draft recommendations were then prepared, and a systematic literature search was conducted by a medical librarian based on the findings of the initial literature search and draft recommendations. The Medline, Embase, CINAHL, and Cochrane medical databases were initially searched from 1975 to October 2015. Google Scholar was also searched without limiters. An updated search was conducted from November 2015 to November 2017, search strings for which are included in Appendix 3. All article abstracts were first screened for relevance by at least two members of the working group. Full-text versions of screened articles were reviewed and articles on ultrasound guidance for paracentesis were selected. The following article types were excluded: non-English language, nonhuman, age <18 years, meeting abstracts, meeting posters, letters, and editorials. All relevant systematic reviews, meta-analyses, randomized controlled trials, and observational studies of ultrasound-guided paracentesis were screened and selected. Final article selection was based on working group consensus. The selected literature was incorporated into the draft recommendations.

We used the RAND Appropriateness Method that required panel judgment and consensus to establish recommendations.³⁰ The voting members of the SHM POCUS Task Force reviewed and voted on the draft recommendations considering five transforming factors: (1) problem priority and importance; (2) level of quality of evidence; (3) benefit/harm balance; (4) benefit/burden balance; and (5) certainty/concerns about preferences/equity acceptability/feasibility. Panel members participated in two rounds of electronic voting using an internet-based electronic data collection tool (Redcap™) during February 2018 and April 2018 (Appendix 4) and voting on appropriateness was conducted using a 9-point Likert scale. The three zones based on the 9-point Likert scale were inappropriate (1-3 points), uncertain (4-6 points), and appropriate (7-9 points), and the degree of consensus was assessed using the RAND algorithm (Appendix 1, Figure 1, and Table 1). Establishing a recommendation required at least 70% agreement that a recommendation was “appropriate.” A strong recommendation required 80% of the votes within one integer of the median, following RAND rules, and disagreement was defined as >30% of panelists voting outside of the zone of the median.

Recommendations were classified as strong or weak/conditional based on preset rules defining the panel’s level of consensus, which determined the wording for each recommendation (Tables 1 and 2). The revised consensus-based recommendations underwent internal and external review by POCUS experts from different subspecialties, and a final review of the guideline document was performed by members of the SHM POCUS Task Force, SHM Education Committee, and SHM Board of Directors. The SHM Board of Directors endorsed the document prior to submission to the Journal of Hospital Medicine.

RESULTS

Literature search

A total of 794 references were pooled and screened from literature searches conducted by a certified medical librarian in October 2015 (604 citations) and updated in November 2017 (118 citations), and working group members’ personal bibliographies and searches (72 citations; Appendix 3, Figure 2). Final selection included 91 articles that were abstracted into a data table and incorporated into the draft recommendations.

RECOMMENDATIONS

Four domains (terminology, clinical outcomes, technique, and training) with 13 draft recommendations were generated based on the literature review by the paracentesis working group. After two rounds of panel voting, one recommendation did not achieve consensus based on the RAND rules, and 12 statements received final approval. The degree of consensus based on the median score and dispersion of voting around the median are shown in Appendix 5. All 12 statements achieved consensus as strong recommendations. The strength of each recommendation and degree of consensus are summarized in Table 3.

Terminology

Abdominal paracentesis is a procedure in which fluid is aspirated from the intraperitoneal space by percutaneous insertion of a needle with or without a catheter through the abdominal wall. Throughout this document, the term “paracentesis” refers to “abdominal paracentesis.”

In this document, ultrasound-guided paracentesis refers to the use of static ultrasound guidance to mark a needle insertion site immediately prior to performing the procedure. Real-time (dynamic) ultrasound guidance refers to tracking of the needle tip with ultrasound as it traverses the abdominal wall to enter the peritoneal cavity. Landmark-based paracentesis refers to paracentesis based on physical examination alone.

RECOMMENDATIONS

Clinical outcomes

1. We recommend that ultrasound guidance should be used for paracentesis to reduce the risk of serious complications, the most common being bleeding.

Rationale. The occurrence of both minor and serious life-threatening complications from paracentesis has been well described.^5-10,31,32 A recent retrospective study that evaluated 515 landmark-guided paracenteses noted that the most common minor complication was persistent ascites leakage (5%) and that the most common serious complication was postprocedural bleeding (1%).⁸ Studies have shown that abdominal wall hematoma and hemoperitoneum are common hemorrhagic complications of paracentesis, although inferior epigastric artery pseudoaneurysm has also been described.^9,33,34

Current literature suggests that ultrasound-guided paracentesis is a safe procedure, even with reduced platelet counts or elevated international normalized ratio.^35-42 Most comparative studies have shown that ultrasound guidance reduces the risk of bleeding complications compared with the use of landmarks alone,^{7,31,32,43-45} although a few studies did not find a significant difference between techniques.^20,36,46 One large retrospective observational study that analyzed the administrative data of 69,859 paracenteses from more than 600 hospitals demonstrated that ultrasound guidance reduced the odds of bleeding complications by 68% (OR, 0.32; 95% CI, 0.25–0.41). Bleeding complication rates with and without the use of ultrasound guidance were 0.27% (CI 0.26-0.29) versus 1.25% (CI 1.21-1.29; P < .0001), respectively. More importantly, in this study, paracentesis complicated by bleeding was associated with a higher in-hospital mortality rate compared to paracentesis that were not complicated by bleeding (12.9% vs 3.7%; P < .0001).⁴³

2. We recommend that ultrasound guidance should be used to avoid attempting paracentesis in patients with an insufficient volume of intraperitoneal free fluid to drain.

Rationale. Abdominal physical examination is not a reliable method for determining the presence or volume of intraperitoneal free fluid, as no specific physical examination finding has consistently shown both high sensitivity and specificity for detecting intraperitoneal free fluid.^{11,12,20,31,47-51} Patient factors limiting the diagnostic accuracy of physical examination include body habitus, abdominal wall edema, and gaseous bowel distention.

In comparative studies, ultrasound has been found to be significantly more sensitive and specific than physical examination in detecting peritoneal free fluid.^11,12 Ultrasound can detect as little as 100 mL of peritoneal free fluid,^52,53 and larger volumes of fluid have higher diagnostic accuracy.^53-55 In one randomized trial of 100 patients suspected of having ascites, patients were randomized to landmark-based and ultrasound-guided paracentesis groups. Of the 56 patients in the ultrasound-guided group, 14 patients suspected of having ascites on physical examination were found to have no or an insufficient volume of ascites to attempt paracentesis.²⁰ Another study with 41 ultrasound examinations on cancer patients suspected of having intraperitoneal free fluid by history and physical examination demonstrated that only 19 (46%) were considered to have a sufficient volume of ascites by ultrasound to attempt paracentesis.³⁸

3. We recommend that ultrasound guidance should be used for paracentesis to improve the success rates of the overall procedure.

Rationale. In addition to avoiding drainage attempts in patients with an insufficient volume of intraperitoneal free fluid, ultrasound can increase the success rate of attempted procedures by localizing the largest fluid collection and guiding selection of an optimal needle insertion site. The success rates of landmark-based paracentesis in patients suspected of having intraperitoneal free fluid by physical examination are not well described in the literature, but multiple studies report success rates of 95%-100% for paracentesis when using ultrasound guidance to select a needle insertion site.^20,38,56,57 In one randomized trial comparing ultrasound-guided versus landmark-based paracentesis, ultrasound-guided paracentesis revealed a significantly higher success rate (95% of procedures performed) compared with landmark-based parancentesis (61% of procedures performed). Moreover, 87% of the initial failures in the landmark-based group underwent subsequent successful paracentesis when ultrasound guidance was used. Ultrasound revealed that the rest of the patients (13%) did not have enough fluid to attempt ultrasound-guided paracentesis.²⁰

Technique

4. We recommend that ultrasound should be used to assess the characteristics of intraperitoneal free fluid to guide clinical decision making of where paracentesis can be safely performed.

Rationale. The presence and characteristics of intraperitoneal fluid collections are important determinants of whether paracentesis, another procedure, or no procedure should be performed in a given clinical scenario. One study reported that the overall diagnostic accuracy of physical examination for detecting ascites was only 58%,⁵⁰ and many providers are unable to detect ascites by physical examination until 1L of fluid has accumulated. One small study showed that at least 500 ml of fluid must accumulate before shifting dullness could be detected.⁵⁸ By contrast, ultrasound has been shown to reliably detect as little as 100 mL of peritoneal free fluid ^52,53 and has been proven to be superior to physical examination in several studies.^11,12 Therefore, ultrasound can be used to qualitatively determine whether a sufficient volume of intraperitoneal free fluid is present to safely perform paracentesis.

Studies have shown that ultrasound can also be used to differentiate ascites from other pathologies (eg, matted bowel loops, metastases, abscesses) in patients with suspected ascites on history and physical examination.¹⁶ In addition, ultrasound can help to better understand the etiology and distribution of the ascites.^59-61 Sonographic measurements allow semiquantitative assessment of the volume of intraperitoneal free fluid, which may correlate with the amount of fluid removed in therapeutic paracentesis procedures.^62,63 Furthermore, depth of a fluid collection by ultrasound may be an independent risk factor for the presence of spontaneous bacterial peritonitis (SBP), with one small study showing a higher risk of SBP with larger fluid collections than with small ones.⁶⁴

5. We recommend that ultrasound should be used to identify a needle insertion site based on size of the fluid collection, thickness of the abdominal wall, and proximity to abdominal organs.

Rationale. When providers perform paracentesis using ultrasound guidance, any fluid collection that is directly visualized and accessible may be considered for drainage. The presence of ascites using ultrasound is best detected using a low-frequency transducer, such as phased array or curvilinear transducer, which provides deep penetration into the abdomen and pelvis to assess peritoneal free fluid.^{13,14,45,51,65} An optimal needle insertion site should be determined based on a combination of visualization of largest fluid collection, avoidance of underlying abdominal organs, and thickness of abdominal wall.^13,31,66,67

6. We recommend the needle insertion site should be evaluated using color flow Doppler ultrasound to identify and avoid abdominal wall blood vessels along the anticipated needle trajectory.

Rationale. The anatomy of the superficial blood vessels of the abdominal wall, especially the lateral branches, varies greatly.^68-70 Although uncommon, inadvertent laceration of an inferior epigastric artery or one of its large branches is associated with significant morbidity and mortality.^{10,15,69,71-73} A review of 126 cases of rectus sheath hematomas, which most likely occur due to laceration of the inferior or superior epigastric artery, at a single institution from 1992 to 2002 showed a mortality rate of 1.6%, even with aggressive intervention.⁷⁴ Besides the inferior epigastric arteries, several other blood vessels are at risk of injury during paracentesis, including the inferior epigastric veins, thoracoepigastric veins, subcostal artery and vein branches, deep circumflex iliac artery and vein, and recanalized subumbilical vasculature.^75-77 Laceration of any of the abdominal wall blood vessels could result in catastrophic bleeding.

Identification of abdominal wall blood vessels is most commonly performed with a high-frequency transducer using color flow Doppler ultrasound.^10,13-15 A low-frequency transducer capable of color flow Doppler ultrasound may be utilized in patients with a thick abdominal wall.

Studies suggest that detection of abdominal wall blood vessels with ultrasound may reduce the risk of bleeding complications. One study showed that 43% of patients had a vascular structure present at one or more of the three traditional landmark paracentesis sites.⁷⁸ Another study directly compared bleeding rates between an approach utilizing a low-frequency transducer to identify the largest collection of fluid only versus a two-transducer approach utilizing both low and high-frequency transducers to identify the largest collection of fluid and evaluate for any superficial blood vessels. In this study, which included 5,777 paracenteses, paracentesis-related minor bleeding rates were similar in both groups, but major bleeding rates were less in the group utilizing color flow Doppler to evaluate for superficial vessels (0.3% vs 0.08%); differences found between groups, however, did not reach statistical significance (P = .07).⁷⁹

7. We recommend that a needle insertion site should be evaluated in multiple planes to ensure clearance from underlying abdominal organs and detect any abdominal wall blood vessels along the anticipated needle trajectory.

Rationale. Most ultrasound machines have a slice thickness of <4 mm at the focal zone.⁸⁰ Considering that an ultrasound beam represents a very thin 2-dimentional cross-section of the underlying tissues, visualization in only one plane could lead to inadvertent puncture of nearby critical structures such as loops of bowel or edges of solid organs. Therefore, it is important to evaluate the needle insertion site and surrounding areas in multiple planes by tilting the transducer and rotating the transducer to orthogonal planes.⁶¹ Additionally, evaluation with color flow Doppler could be performed in a similar fashion to ensure that no large blood vessels are along the anticipated needle trajectory.

8. We recommend that a needle insertion site should be marked with ultrasound immediately before performing the procedure, and the patient should remain in the same position between marking the site and performing the procedure.

Rationale. Free-flowing peritoneal fluid and abdominal organs, especially loops of small bowel, can easily shift when a patient changes position or takes a deep breath.^13,16,53 Therefore, if the patient changes position or there is a delay between marking the needle insertion site and performing the procedure, the patient should be reevaluated with ultrasound to ensure that the marked needle insertion site is still safe for paracentesis.⁷⁸ After marking the needle insertion site, the skin surface should be wiped completely clean of gel, and the probe should be removed from the area before sterilizing the skin surface.

9. We recommend that using real-time ultrasound guidance for paracentesis should be considered when the fluid collection is small or difficult to access.

Rationale. Use of real-time ultrasound guidance for paracentesis has been described to drain abdominal fluid collections.^13,20,62 Several studies have commented that real-time ultrasound guidance for paracentesis may be necessary in obese patients, in patients with small fluid collections, or when performing the procedure near critical structures, such as loops of small bowel, liver, or spleen.^57,81 Real-time ultrasound guidance for paracentesis requires additional training in needle tracking techniques and specialized equipment to maintain sterility.

Training

10. We recommend that dedicated training sessions, including didactics, supervised practice on patients, and simulation-based practice, should be used to teach novices how to perform ultrasound-guided paracentesis.

Rationale. Healthcare providers must gain multiple skills to safely perform ultrasound-guided paracentesis. Trainees must learn how to operate the ultrasound machine to identify the most appropriate needle insertion site based on the abdominal wall thickness, fluid collection size, proximity to nearby abdominal organs, and presence of blood vessels. Education regarding the use of ultrasound guidance for paracentesis is both desired ^82,83 and being increasingly taught to health care providers who perform paracentesis.^20,84-86

Several approaches have shown high uptake of essential skills to perform ultrasound-guided paracentesis after short training sessions. One study showed that first-year medical students can be taught to use POCUS to accurately diagnose ascites after three 30-minute teaching sessions.¹⁹ Another study showed that emergency medicine residents can achieve high levels of proficiency in the preprocedural ultrasound evaluation for paracentesis with only one hour of didactic training.²⁰ Other studies also support the concept that adequate proficiency is achievable within brief, focused training sessions.^21-28 However, these skills can decay significantly over time without ongoing education.⁸⁷

11. We recommend that simulation-based practice should be used, when available, to facilitate acquisition of the required knowledge and skills to perform ultrasound-guided paracentesis.

Rationale. Simulation-based practice should be used when available, as it has been shown to increase competence in bedside diagnostic ultrasonography and procedural techniques for ultrasound-guided procedures, including paracentesis.^{22,25,29,88,89} One study showed that internal medicine residents were able to achieve a high level of proficiency to perform ultrasound-guided paracentesis after a three-hour simulation-based mastery learning session.⁸⁸ A follow-up study suggested that, after sufficient simulation-based training, a nonradiologist can perform ultrasound-guided paracentesis as safely as an interventional radiologist.²⁹

12. We recommend that competence in performing ultrasound-guided paracentesis should be demonstrated prior to independently performing the procedure on patients.

Rationale. Competence in ultrasound-guided paracentesis requires acquisition of clinical knowledge of paracentesis, skills in basic abdominal ultrasonography, and manual techniques to perform the procedure. Competence in ultrasound-guided paracentesis cannot be assumed for those graduating from internal medicine residency in the United States. While clinical knowledge of paracentesis remains a core competency of graduating internal medicine residents per the American Board of Internal Medicine, demonstration of competence in performing ultrasound-guided or landmark-based paracentesis is not currently mandated.⁹⁰ A recent national survey of internal medicine residency program directors revealed that the curricula and resources available to train residents in bedside diagnostic ultrasound and ultrasound-guided procedures, including paracentesis, remain quite variable. ⁸³

While it has not been well studied, competence in ultrasound for paracentesis, as with all other skills involved in bedside procedures, is likely best evaluated through direct observation on actual patients.⁹¹ As such, individualized systems to evaluate competency in ultrasound-guided paracentesis should be established for each site where it is performed. A list of consensus-derived ultrasound competencies for ultrasound-guided paracentesis has been proposed, and this list may serve as a guide for both training curriculum development and practitioner evaluation.^86,91,92

KNOWLEDGE GAPS

In the process of developing these recommendations, we identified several important gaps in the literature regarding the use of ultrasound guidance for paracentesis.

First, while some data suggest that the use of ultrasound guidance for paracentesis may reduce the inpatient length of stay and overall costs, this suggestion has not been studied rigorously. In a retrospective review of 1,297 abdominal paracenteses by Patel et al., ultrasound-guided paracentesis was associated with a lower incidence of adverse events compared with landmark-based paracentesis (1.4% vs 4.7%; P = .01). The adjusted analysis from this study showed significant reductions in adverse events (OR 0.35; 95%CI 0.165-0.739; P = .006) and hospitalization costs ($8,761 ± $5,956 vs $9,848 ± $6,581; P < .001) for paracentesis with ultrasound guidance versus without such guidance. Additionally, the adjusted average length of stay was 0.2 days shorter for paracentesis with ultrasound guidance versus that without guidance (5.6 days vs 5.8 days; P < .0001).⁴⁴ Similar conclusions were reached by Mercaldi et al., who conducted a retrospective study of 69,859 patients who underwent paracentesis. Fewer bleeding complications occurred when paracentesis was performed with ultrasound guidance (0.27%) versus without ultrasound guidance (1.27%). Hospitalization costs increased by $19,066 (P < .0001) and length of stay increased by 4.3 days (P < .0001) for patients when paracentesis was complicated by bleeding.⁴³ Because both of these studies were retrospective reviews of administrative databases, associations between procedures, complications, and use of ultrasound may be limited by erroneous coding and documentation.

Second, regarding technique, it is unknown whether the use of real-time ultrasound guidance confers additional benefits compared with use of static ultrasound to mark a suitable needle insertion site. In clinical practice, real-time ultrasound guidance is used to sample small fluid collections, particularly when loops of bowel or a solid organ are nearby. It is possible that higher procedural success rates and lower complication rates may be demonstrated in these scenarios in future studies.

Third, the optimal approach to train providers to perform ultrasound-guided paracentesis is unknown. While short training sessions have shown high uptake of essential skills to perform ultrasound-guided paracentesis, data regarding the effectiveness of training using a comprehensive competency assessment are limited. Simulation-based mastery learning as a means to obtain competency for paracentesis has been described in one study,⁸⁸ but the translation of competency demonstrated by simulation to actual patient outcomes has not been studied. Furthermore, the most effective method to train providers who are proficient in landmark-based paracentesis to achieve competency in ultrasound-guided paracentesis has not been well studied.

Fourth, the optimal technique for identifying blood vessels in the abdominal wall is unknown. We have proposed that color flow Doppler should be used to identify and avoid puncture of superficial vessels, but power Doppler is three times more sensitive at detecting blood vessels, especially at low velocities, such as in veins independent of direction or flow.⁹³ Hence using power Doppler instead of color flow Doppler may further improve the ability to identify and avoid superficial vessels along the needle trajectory.⁹²

Finally, the impact of ultrasound use on patient experience has yet to be studied. Some studies in the literature show high patient satisfaction with use of ultrasound at the bedside,^94,95 but patient satisfaction with ultrasound-guided paracentesis has not been compared directly with the landmark-based technique.

CONCLUSIONS

The use of ultrasound guidance for paracentesis has been associated with higher success rates and lower complication rates. Ultrasound is superior to physical examination in assessing the presence and volume of ascites, and determining the optimal needle insertion site to avoid inadvertent injury to abdominal wall blood vessels. Hospitalists can attain competence in ultrasound-guided paracentesis through the use of various training methods, including lectures, simulation-based practice, and hands-on training. Ongoing use and training over time is necessary to maintain competence.

Acknowledgments

The authors thank all the members of the Society of Hospital Medicine Point-of-care Ultrasound Task Force and the Education Committee members for their time and dedication to develop these guidelines.

SHM Point-of-care Ultrasound Task Force: CHAIRS: Nilam Soni, Ricardo Franco Sadud, Jeff Bates. WORKING GROUPS: Thoracentesis Working Group: Ria Dancel (chair), Daniel Schnobrich, Nitin Puri. Vascular Access Working Group: Ricardo Franco (chair), Benji Matthews, Saaid Abdel-Ghani, Sophia Rodgers, Martin Perez, Daniel Schnobrich. Paracentesis Working Group: Joel Cho (chair), Benji Mathews, Kreegan Reierson, Anjali Bhagra, Trevor P. Jensen. Lumbar Puncture Working Group: Nilam J. Soni (chair), Ricardo Franco, Gerard Salame, Josh Lenchus, Venkat Kalidindi, Ketino Kobaidze. Credentialing Working Group: Brian P Lucas (chair), David Tierney, Trevor P. Jensen PEER REVIEWERS: Robert Arntfield, Michael Blaivas, Richard Hoppmann, Paul Mayo, Vicki Noble, Aliaksei Pustavoitau, Kirk Spencer, Vivek Tayal. METHODOLOGIST: Mahmoud El Barbary. LIBRARIAN: Loretta Grikis. SOCIETY OF HOSPITAL MEDICINE EDUCATION COMMITTEE: Daniel Brotman (past chair), Satyen Nichani (current chair), Susan Hunt. SOCIETY OF HOSPITAL MEDICINE STAFF: Nick Marzano.

Collaborators of the Society of Hospital Medicine Point-of-care Ultrasound Task Force

Saaid Abdel-Ghani, Robert Arntfield, Jeffrey Bates, Michael Blaivas, Dan Brotman, Carolina Candotti, Richard Hoppmann, Susan Hunt, Venkat Kalidindi, Ketino Kobaidze, Josh Lenchus, Paul Mayo, Satyen Nichani, Vicki Noble, Martin Perez, Nitin Puri, Aliaksei Pustavoitau, Sophia Rodgers, Gerard Salame, Daniel Schnobrich, Kirk Spencer, Vivek Tayal, David M. Tierney

Disclaimer

The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

All 5 appendices are viewable online at https://www.journalofhospitalmedicine.com.

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35. Cervini P, Hesley GK, Thompson RL, Sampathkumar P, Knudsen JM. Incidence of infectious complications after an ultrasound-guided intervention. AJR Am J Roentgenol. 2010;195(4):846-850. doi: 10.2214/AJR.09.3168.
36. Wiese SS, Mortensen C, Bendtsen F. Few complications after paracentesis in patients with cirrhosis and refractory ascites. Dan Med Bull. 2011;58(1):A4212.
37. Jakobson DJ, Shemesh I. Merging ultrasound in the intensive care routine. Isr Med Assoc J. 2013;15(11):688-692.
38. Landers A, Ryan B. The use of bedside ultrasound and community-based paracentesis in a palliative care service. J Prim Health Care. 2014;6(2):148-151.
39. Lin CH, Shih FY, Ma MH, Chiang WC, Yang CW, Ko PC. Should bleeding tendency deter abdominal paracentesis? Dig Liver Dis. 2005;37(12):946-951. doi: 10.1016/j.dld.2005.07.009.
40. Kurup AN, Lekah A, Reardon ST, et al. Bleeding rate for ultrasound-guided paracentesis in thrombocytopenic patients. J Ultrasound Med. 2015;34(10):1833-1838. doi: 10.7863/ultra.14.10034.
41. Reardon S, Atwell TD, Lekah A. Major bleeding complication rate of ultrasound-guided paracentesis in thrombocytopenic patients. J Vasc Interv Radiol. 2013;24(4):S56. doi: 10.1016/j.jvir.2013.01.129.
42. Czul F, Prager M, Lenchus J. Intra-procedural risk of bleeding associated with ultrasound guided paracentesis in patients with abnormal coagulation studies: 1907. Hepatology. 2011;54(4):1259A.
43. Mercaldi CJ, Lanes SF. Ultrasound guidance decreases complications and improves the cost of care among patients undergoing thoracentesis and paracentesis. Chest. 2013;143(2):532-538. doi: 10.1378/chest.12-0447.
44. Patel PA, Ernst FR, Gunnarsson CL. Evaluation of hospital complications and costs associated with using ultrasound guidance during abdominal paracentesis procedures. J Med Econ. 2012;15(1):1-7. doi: 10.3111/13696998.2011.628723.
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53. Goldberg BB, Goodman GA, Clearfield HR. Evaluation of ascites by ultrasound. Radiology. 1970;96(1):15-22. doi: 10.1148/96.1.15.
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55. Paajanen H, Lahti P, Nordback I. Sensitivity of transabdominal ultrasonography in detection of intraperitoneal fluid in humans. Eur Radiol. 1999;9(7):1423-1425. doi: 10.1007/s003300050861.
56. Prabhakar A, Thabet A, Mueller P, Gee MS. Image-guided peritoneal access for fluid infusion in oncology patients: Indications, technique, and outcomes. J Vasc Interv Radiol. 2014;25(3):S41. doi: 10.1016/j.jvir.2013.12.100.
57. McGahan JP, Anderson MW, Walter JP. Portable real-time sonographic and needle guidance systems for aspiration and drainage. AJR Am J Roentgenol. 1986;147(6):1241-1246. doi: 10.2214/ajr.147.6.1241.
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61. Beaulieu Y, Marik PE. Bedside ultrasonography in the ICU: part 2. Chest. 2005;128(3):1766-1781. doi: 10.1378/chest.128.3.1766.
62. Irshad A, Ackerman SJ, Anis M, Campbell AS, Hashmi A, Baker NL. Can the smallest depth of ascitic fluid on sonograms predict the amount of drainable fluid? J Clin Ultrasound. 2009;37(8):440-444. doi: 10.1002/jcu.20616.
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64. Sideris A, Patel P, Charles HW, Park J, Feldman D, Deipolyi AR. Imaging and clinical predictors of spontaneous bacterial peritonitis diagnosed by ultrasound-guided paracentesis. Proc (Bayl Univ Med Cent). 2017;30(3):262-264. https://doi.org/10.1080/08998280.2017.11929610
65. Hatch N, Wu TS, Barr L, Roque PJ. Advanced ultrasound procedures. Crit Care Clin. 2014;30(2):305-329. doi: 10.1016/j.ccc.2013.10.005.
66. Ross GJ, Kessler HB, Clair MR, Gatenby RA, Hartz WH, Ross LV. Sonographically guided paracentesis for palliation of symptomatic malignant ascites. AJR Am J Roentgenol. 1989;153(6):1309-1311. doi: 10.2214/ajr.153.6.1309.
67. Russell KW, Mone MC, Scaife CL. Umbilical paracentesis for acute hernia reduction in cirrhotic patients. BMJ Case Rep. 2013;2013. doi: 10.1136/bcr-2013-201304.
68. Epstein J, Arora A, Ellis H. Surface anatomy of the inferior epigastric artery in relation to laparoscopic injury. Clin Anat. 2004;17(5):400-408. doi: 10.1002/ca.10192.
69. Suzuki J, Sekiguchi H. Laceration of inferior epigastric artery resulting in abdominal compartment syndrome: a fatal complication of paracentesis. Am J Respir Crit Care Med. 2012;185:A5974. doi: 10.1164/ajrccm-conference.2012.185.1_MeetingAbstracts.A5974
70. Saber AA, Meslemani AM, Davis R, Pimentel R. Safety zones for anterior abdominal wall entry during laparoscopy: a CT scan mapping of epigastric vessels. Ann Surg. 2004;239(2):182-185. doi: 10.1097/01.sla.0000109151.53296.07.
71. Webster ST, Brown KL, Lucey MR, Nostrant TT. Hemorrhagic complications of large volume abdominal paracentesis. Am J Gastroenterol. 1996;91(2):366-368.
72. Todd AW. Inadvertent puncture of the inferior epigastric artery during needle biopsy with fatal outcome. Clin Radiol. 2001;56(12):989-990. doi: 10.1053/crad.2001.0175.
73. Seidler M, Sayegh K, Roy A, Mesurolle B. A fatal complication of ultrasound-guided abdominal paracentesis. J Clin Ultrasound. 2013;41(7):457-460. doi: 10.1002/jcu.22050.
74. Cherry WB, Mueller PS. Rectus sheath hematoma: review of 126 cases at a single institution. Medicine (Baltimore). 2006;85(2):105-110. doi: 10.1097/01.md.0000216818.13067.5a.
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76. Krupski WC, Sumchai A, Effeney DJ, Ehrenfeld WK. The importance of abdominal wall collateral blood vessels. Planning incisions and obtaining arteriography. Arch Surg. 1984;119(7):854-857. doi: 10.1001/archsurg.1984.01390190092021.
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78. Adams A, Roggio A, Wilkerson RG. 368 Sonographic assessment of inadvertent vascular puncture during paracentesis using the traditional landmark approach. Ann Emerg Med. 2015;66:S132-S133. doi: 10.1016/j.annemergmed.2015.07.404
79. Barsuk JH, Rosen BT, Cohen ER, Feinglass J, Ault MJ. Vascular ultrasonography: a novel method to reduce paracentesis related major bleeding. J Hosp Med. 2018;13(1):30-33. doi: 10.12788/jhm.2863.
80. Skolnick ML. Estimation of ultrasound beam width in the elevation (section thickness) plane. Radiology. 1991;180(1):286-288. doi: 10.1148/radiology.180.1.2052713.
81. Keil-Rios D, Terrazas-Solis H, Gonzalez-Garay A, Sanchez-Avila JF, Garcia-Juarez I. Pocket ultrasound device as a complement to physical examination for ascites evaluation and guided paracentesis. Intern Emerg Med. 2016;11(3):461-466. doi: 10.1007/s11739-016-1406-x.
82. Kessler C, Bhandarkar S. Ultrasound training for medical students and internal medicine residents--a needs assessment. J Clin Ultrasound. 2010;38(8):401-408. doi: 10.1002/jcu.20719.
83. Schnobrich DJ, Gladding S, Olson AP, Duran-Nelson A. Point-of-care ultrasound in internal medicine: a national survey of educational leadership. J Grad Med Educ. 2013;5(3):498-502. doi: 10.4300/JGME-D-12-00215.1.
84. Eisen LA, Leung S, Gallagher AE, Kvetan V. Barriers to ultrasound training in critical care medicine fellowships: a survey of program directors. Crit Care Med. 2010;38(10):1978-1983. doi: 10.1097/CCM.0b013e3181eeda53.
85. Neri L, Storti E, Lichtenstein D. Toward an ultrasound curriculum for critical care medicine. Crit Care Med. 2007;35(5 Suppl):S290-304. doi: 10.1097/01.CCM.0000260680.16213.26.
86. Ma I, Arishenkoff S, Wiseman J, et al. Internal medicine point-of-care ultrasound curriculum: consensus recommendations from the Canadian Internal Medicine Ultrasound (CIMUS) Group. J Gen Intern Med. 2017;32(9):1052-1057. doi: 10.1007/s11606-017-4071-5.
87. Kelm D, Ratelle J, Azeem N, et al. Longitudinal ultrasound curriculum improves long-term retention among internal medicine residents. J Grad Med Educ. 2015;7(3):454-457. doi: 10.4300/JGME-14-00284.1.
88. Barsuk JH, Cohen ER, Vozenilek JA, O’Connor LM, McGaghie WC, Wayne DB. Simulation-based education with mastery learning improves paracentesis skills. J Grad Med Educ. 2012;4(1):23-27. doi: 10.4300/JGME-D-11-00161.1.
89. Lenchus JD. End of the “see one, do one, teach one” era: the next generation of invasive bedside procedural instruction. J Am Osteopath Assoc. 2010;110(6):340-346. doi: 10.7556/jaoa.2010.110.6.340.
90. American Board of Internal Medicine. Policies and Procedures for Certification. Philadelphia, PA: ABIM; 2006.
91. Lucas BP, Tierney DM, Jensen TP, et al. Credentialing of hospitalists in ultrasound-guided bedside procedures: a position statement of the Society of Hospital Medicine. J Hosp Med. 2018;13(2):117-125. doi: 10.12788/jhm.2917.
92. Brown GM, Otremba M, Devine LA, Gray C, Millington SJ, Ma IW. Defining competencies for ultrasound-guided bedside procedures: consensus opinions from Canadian physicians. J Ultrasound Med. 2016;35(1):129-141. doi: 10.7863/ultra.15.01063.
93. Babcock DS, Patriquin H, LaFortune M, Dauzat M. Power doppler sonography: basic principles and clinical applications in children. Pediatr Radiol. 1996;26(2):109-115. doi: 10.1007/BF01372087.
94. Howard ZD, Noble VE, Marill KA, et al. Bedside ultrasound maximizes patient satisfaction. J Emerg Med. 2014;46(1):46-53. doi: 10.1016/j.jemermed.2013.05.044.
95. Lindelius A, Torngren S, Nilsson L, Pettersson H, Adami J. Randomized clinical trial of bedside ultrasound among patients with abdominal pain in the emergency department: impact on patient satisfaction and health care consumption. Scand J Trauma Resusc Emerg Med. 2009;17:60. doi: 10.1186/1757-7241-17-60.

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¹Department of Hospital Medicine, Kaiser Permanente San Francisco Medical Center, San Francisco, California; ²Division of Hospital Medicine, University of California San Francisco Medical Center at Parnassus, San Francisco, California; ³Department of Hospital Medicine, HealthPartners Medical Group, Regions Hospital, St. Paul, Minnesota; ⁴Division of General Internal Medicine, University of Minnesota Medical School, Minneapolis, Minnesota; ⁵Division of General Internal Medicine, Mayo Clinic, Rochester, Minnesota; ⁶Division of General Internal Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin; ⁷White River Junction VA Medical Center, White River Junction, Vermont; ⁸Divisions of General & Hospital Medicine and Pulmonary & Critical Care Medicine, University of Texas Health San Antonio, San Antonio, Texas; ⁹Section of Hospital Medicine, South Texas Veterans Health Care System, San Antonio, Texas; ¹⁰Division of Hospital Medicine, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina; ¹¹Division of General Pediatrics and Adolescent Medicine, Department of Pediatrics, University of North Carolina, Chapel Hill, North Carolina; ¹²Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire; ¹³Medicine Service, White River Junction VA Medical Center, White River Junction, Vermont.

Disclosures

Mr. Mader reports grants from Department of Veterans Affairs during the conduct of the study. Dr. Soni reports grants from the Department of Veterans Affairs Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative Grant (HX002263-01A1) outside of the submitted work. In addition, Dr. Soni receives royalties from Elsevier-Saunders. All other authors have nothing to disclose.

Funding

Brian P Lucas: Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development and Dartmouth SYNERGY, National Institutes of Health, National Center for Translational Science (UL1TR001086). Nilam Soni: Department of Veterans Affairs, Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative Grant (HX002263-01A1), outside the submitted work. )

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Joel Cho, MD RDMS RDCS

Trevor P. Jensen, MD MS

Kreegan Reierson, MD

Benji K. Mathews, MD

Anjali Bhagra, MD

Ricardo Franco-Sadud, MD

Loretta Grikis, MLS

Michael Mader, MS

Ria Dancel, MD

Brian P. Lucas, MD MS

Society of Hospital Medicine Point-of-care Ultrasound Task Force

Nilam J. Soni, MD, MS

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Joel Cho, MD RDMS RDCS

Trevor P. Jensen, MD MS

Kreegan Reierson, MD

Benji K. Mathews, MD

Anjali Bhagra, MD

Ricardo Franco-Sadud, MD

Loretta Grikis, MLS

Michael Mader, MS

Ria Dancel, MD

Brian P. Lucas, MD MS

Society of Hospital Medicine Point-of-care Ultrasound Task Force

Nilam J. Soni, MD, MS

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METHODS

RESULTS

Literature search

RECOMMENDATIONS

Terminology

RECOMMENDATIONS

Clinical outcomes

1. We recommend that ultrasound guidance should be used for paracentesis to reduce the risk of serious complications, the most common being bleeding.

2. We recommend that ultrasound guidance should be used to avoid attempting paracentesis in patients with an insufficient volume of intraperitoneal free fluid to drain.

3. We recommend that ultrasound guidance should be used for paracentesis to improve the success rates of the overall procedure.

Technique

4. We recommend that ultrasound should be used to assess the characteristics of intraperitoneal free fluid to guide clinical decision making of where paracentesis can be safely performed.

5. We recommend that ultrasound should be used to identify a needle insertion site based on size of the fluid collection, thickness of the abdominal wall, and proximity to abdominal organs.

6. We recommend the needle insertion site should be evaluated using color flow Doppler ultrasound to identify and avoid abdominal wall blood vessels along the anticipated needle trajectory.

7. We recommend that a needle insertion site should be evaluated in multiple planes to ensure clearance from underlying abdominal organs and detect any abdominal wall blood vessels along the anticipated needle trajectory.

8. We recommend that a needle insertion site should be marked with ultrasound immediately before performing the procedure, and the patient should remain in the same position between marking the site and performing the procedure.

9. We recommend that using real-time ultrasound guidance for paracentesis should be considered when the fluid collection is small or difficult to access.

Training

10. We recommend that dedicated training sessions, including didactics, supervised practice on patients, and simulation-based practice, should be used to teach novices how to perform ultrasound-guided paracentesis.

11. We recommend that simulation-based practice should be used, when available, to facilitate acquisition of the required knowledge and skills to perform ultrasound-guided paracentesis.

12. We recommend that competence in performing ultrasound-guided paracentesis should be demonstrated prior to independently performing the procedure on patients.

KNOWLEDGE GAPS

In the process of developing these recommendations, we identified several important gaps in the literature regarding the use of ultrasound guidance for paracentesis.

CONCLUSIONS

Acknowledgments

Collaborators of the Society of Hospital Medicine Point-of-care Ultrasound Task Force

Disclaimer

The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

All 5 appendices are viewable online at https://www.journalofhospitalmedicine.com.

METHODS

RESULTS

Literature search

RECOMMENDATIONS

Terminology

RECOMMENDATIONS

Clinical outcomes

1. We recommend that ultrasound guidance should be used for paracentesis to reduce the risk of serious complications, the most common being bleeding.

2. We recommend that ultrasound guidance should be used to avoid attempting paracentesis in patients with an insufficient volume of intraperitoneal free fluid to drain.

3. We recommend that ultrasound guidance should be used for paracentesis to improve the success rates of the overall procedure.

Technique

4. We recommend that ultrasound should be used to assess the characteristics of intraperitoneal free fluid to guide clinical decision making of where paracentesis can be safely performed.

5. We recommend that ultrasound should be used to identify a needle insertion site based on size of the fluid collection, thickness of the abdominal wall, and proximity to abdominal organs.

6. We recommend the needle insertion site should be evaluated using color flow Doppler ultrasound to identify and avoid abdominal wall blood vessels along the anticipated needle trajectory.

7. We recommend that a needle insertion site should be evaluated in multiple planes to ensure clearance from underlying abdominal organs and detect any abdominal wall blood vessels along the anticipated needle trajectory.

8. We recommend that a needle insertion site should be marked with ultrasound immediately before performing the procedure, and the patient should remain in the same position between marking the site and performing the procedure.

9. We recommend that using real-time ultrasound guidance for paracentesis should be considered when the fluid collection is small or difficult to access.

Training

10. We recommend that dedicated training sessions, including didactics, supervised practice on patients, and simulation-based practice, should be used to teach novices how to perform ultrasound-guided paracentesis.

11. We recommend that simulation-based practice should be used, when available, to facilitate acquisition of the required knowledge and skills to perform ultrasound-guided paracentesis.

12. We recommend that competence in performing ultrasound-guided paracentesis should be demonstrated prior to independently performing the procedure on patients.

KNOWLEDGE GAPS

In the process of developing these recommendations, we identified several important gaps in the literature regarding the use of ultrasound guidance for paracentesis.

CONCLUSIONS

Acknowledgments

Collaborators of the Society of Hospital Medicine Point-of-care Ultrasound Task Force

Disclaimer

The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

All 5 appendices are viewable online at https://www.journalofhospitalmedicine.com.

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Joel Cho, MD, RDMS, RDC

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Potential treatment on the horizon for cold agglutinin disease

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Potential treatment on the horizon for cold agglutinin disease

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HT Staff

Red blood cells

In a first-in-human trial, sutimlimab rapidly halted hemolysis, corrected anemia, precluded the need for transfusion, and caused no serious adverse effects in patients with cold agglutinin disease.

Sutimlimab also “induced clinically meaningful increases in hemoglobin levels, even in patients with multiple previous lines of therapy,” according to investigators.

The European Medicines Agency and the U.S. Food and Drug Administration (FDA) awarded sutimlimab orphan drug status based on these results. The FDA also granted sutimlimab breakthrough therapy designation.

Sutimlimab is a humanized anti-C1s IgG4 monoclonal antibody that blocks the classical complement pathway–specific protease C1s and prevents further hemolysis in patients with cold agglutinin disease.

Cold agglutinin disease is a rare, acquired chronic autoimmune hemolytic condition that destroys red blood cells. It leads to chronic anemia, severe fatigue, and potentially fatal thrombotic events. No drug has yet been approved to treat cold agglutinin disease.

The phase 1 trial of sutimlimab (formerly BIVV009 and TNT009) in cold agglutinin disease was conducted at the Medical University of Vienna in Austria and reported in Blood.

The study (NCT02502903) involved 10 patients, ages 56 to 76, who were previously treated with multiple lines of therapy, including two patients who failed treatment with eculizumab.

Of the 10 patients, eight were female, eight were Caucasian, one was Asian, and one was Hispanic. Patients had cold agglutinin disease for a median of 5 years (range, 1 – 20).

At baseline, the median hemoglobin level was 7.8 g/dL, the median number of reticulocytes was 133 x 10⁹/L, the median bilirubin was 2.0 mg/dL, and the median haptoglobin was less than 12 mg/dL.

The patients received an initial dose of 10 mg/kg intravenous sutimlimab as a test dose to allow rapid wash-out of the drug if unforeseen adverse effects occurred with the first infusion.

One to 4 days later, they received the full dose of 60 mg/kg, followed by three additional weekly doses.

Investigators observed the patients for 49 to 53 days.

Results

Within the first week, patients’ median hemoglobin levels increased by 1.6 g/dL (P=0.007), and the median best response was an increase of 3.9 g/dL (P=0.005) after 6 weeks.

Seven patients had increased hemoglobin levels by more than 2 g/dL, and this included those who recently failed to respond or relapsed after rituximab, rituximab plus bendamustine, or eculizumab.

In five patients, hemoglobin increased by 4 g/dL or more. In four patients, it completely normalized to 12 g/dL.

In the first 24 hours after sutimlimab infusion, reticulocyte counts increased by a median of 41% and then gradually declined as hemoglobin levels rose.

In four patients, haptoglobin levels normalized within 1 to 2 weeks. In eight patients who had abnormal bilirubin levels at baseline, sutimlimab decreased the median bilirubin levels by 61%, normalizing levels in most patients within 24 hours of the first infusion (P=0.007).

When sutimlimab was washed out, bilirubin levels increased again, which demonstrated the recurrence of hemolysis.

Approximately 3 to 4 weeks after the last dose of sutimlimab, hemolysis and anemia recurred in all responders.

When patients were re-exposed to sutimlimab, rapid and complete inhibition of hemolysis occurred once again.

None of the patients required packed red blood cell transfusions during treatment.

Safety

The investigators reported that all infusions were well tolerated without premedication and without relevant drug-related adverse effects.

They reported few adverse events during the trial. All were mild or moderate in severity, and most were considered unrelated or unlikely related to sutimlimab.

Two adverse events—one mild purpural rash on both hands and one case of moderate hair loss (each occurring in one patient)—were possibly related to sutimlimab.

While the investigators considered the safety data encouraging, they recommended interpreting the data “cautiously in light of the limited duration of the trial.”

“Provided that safety results remain positive, sutimlimab could become the first approved treatment for cold agglutinin disease,” said corresponding author Bernd Jilma, MD, of the Medical University of Vienna in Austria.

“The drug clearly addresses an unmet medical need, as we have seen rapid, strong responses in patients for whom multiple prior therapies have failed.”

This study was funded by True North Therapeutics, Inc, now part of Bioverativ, a Sanofi company.

Some of the authors disclosed financial relationships, including employment, with True North Therapeutics and Bioverativ.

A phase 3 trial of sutimlimab is underway with top-line results due in 2019.

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