Who Should Direct the CVICU?

By Darryl Weiman, M.D., J.D.

Introduction

The model for taking care of the patient who has had a cardiovascular and/or thoracic procedure is changing. Many hospitals now recognize that the physician directing or co-directing the care of the post-operative cardiothoracic surgical patient should have the knowledge, education, training, and experience to understand the anatomic, developmental, physiologic, and pathophysiologic basis for cardiovascular and pulmonary disease processes. Many universities now believe that this person should be a cardiothoracic surgeon.

Most medical center cardiovascular intensive care units (CVICU) use a multi-disciplinary approach for patient management. They use a hybrid ICU format. Members of the team include critical care nurses, surgeons, cardiologists, pulmonary-critical care, pharmacists, respiratory therapists, social workers, and case managers. The goal of this integrated team is to provide high quality care and minimize adverse events. They all strive for efficient resource management and a seamless patient transition out of the intensive care setting. The one thing this approach lacks is a leader who can oversee the overall management of the patient, especially when the surgeons are focused elsewhere.

The physician taking care of the post-operative cardiac patient should have adequate “hands on” experience in the operative management of such diseases so it is reasonable to have a cardiothoracic surgeon with intensive care experience to lead the multidisciplinary team in the Cardiovascular Intensive Care Unit. This should not result in a turf war as there is a recognized need to have one person oversee the overall care of the individual patient.

Benefits for the Patient

There is no debate that cardiothoracic surgery patients are different from other patients in the intensive care unit. They are generally older, sicker, and frail. Their management has become increasingly complex; even non-operative candidates are undergoing high risk procedures such as (T)rans-catheter Aortic valve replacements (TAVR) and endovascular graft placements in the descending aorta (TEVAR).

More complex tools are being used in the CVICU such as left ventricular assist devices (LVAD) (Intra-aortic balloon pump, Impella, and other LVADs) and vascular access now requires knowledge of Doppler Ultrasound. The knowledge and skills needed to manage these devices is increasing at an exponential rate.

Cardiac arrest in the post-operative cardiac surgical patient shows higher survival rates if the chest is reopened in an expeditious manner. Studies affirm that the chest should be reopened for ventricular fibrillation or ventricular tachycardia that has not responded to 3 DC shocks and amiodarone. Studies have also shown increased survival if the chest is reopened for asystole or severe bradycardia that does not respond to atropine. The chest should also be reopened for pulseless electrical activity (PEA). Cardiac surgeons have the knowledge, experience, and skills needed to open the chest; techniques vary as to the type of closure involved—plates, wires, or a combination of plates and wires.

A study done in 2008 showed that 61% (212/347) of post op coronary revascularization deaths were related to events in the ICU. The reasons given were related to failures of

  1. Diagnosis of life threatening events;
  2. Response of nurse and/or physician;
  3. Patient monitoring;
  4. Decision for timing of reoperation;
  5. Medication dosage and administration;
  6. Communication. 1

A CVICU Director, who is a trained surgeon, should be able to intervene and save some of these patients.

A study done at Stanford University recently concluded that “[i]n its first 2 years, the surgeon-led cardiovascular intensive care unit demonstrated comparable outcomes to the traditional cardiovascular intensive care unit with significant improvements in total length of stay, postoperative transfusions in the cardiovascular intensive care unit, and vasopressor use.”2

Other studies support having a cardiothoracic surgeon manage the postoperative care in the intensive care unit. For example, Whitman, et al showed a decreased length of stay and decreased cost of drugs used postoperatively in a CVICU managed with a cardiothoracic surgeon.3

In an editorial, Hisham Sherif argued strongly that the CVICU should be run by surgeons.

“Deficiencies in the broad-based education, abbreviated clinical training and limited skill sets of non-surgeons seriously impair their situational/environmental awareness and processing of information, their decision-making process and the implementation of decisions, as in the proposed ‘emergent resternotomy in the ICU’ protocol—an often challenging situation for experienced CTS surgeons. Therefore, non-surgeons are not properly qualified to be the primary decision- maker in the high-risk environment of cardiothoracic surgical critical care.”4

Use of the Society of Thoracic Surgeons Data Base

The Society of Thoracic Surgeons continues to monitor quality performance measures in the areas of adult cardiac and general thoracic surgery. These measures are being used by the Centers for Medicare and Medicaid Services (CMS) in their Merit-Based Payment System. These measures are also endorsed by the National Quality Forum. A surgeon well-versed in

these measures can help in seeing that these measures are being followed. He can also help with the checklists needed to document that these measures are being met.

Anti-platelet medication at discharge, Beta blockade at discharge and perioperatively, anti-lipid treatment at discharge, and selection and duration of antibiotic prophylaxis are just a few of the examples of the measures being used in the STS data base.

For Medical Centers that participate in the STS Data base, a surgeon directing the CVICU can help make sure the quality measures are being met, and the data is being captured appropriately by the coders.

Cardiac Surgeons as Intensivists

The American Board of Thoracic Surgery (ABTS) has recognized that critical care has always been a core component of ABTS certification. “Our (D)iplomats have been trained in critical care management of thoracic surgical patients and they have successfully completed both written and oral examinations which cover the critical care aspects of surgical patient management”5

In fact, the ABTS will write a letter on behalf of the Diplomat requesting ICU privileges to the specific credentials committee…to affirm the Diplomat is trained to take care of patients in the intensive care unit.6

The cardiac surgeon is uniquely qualified to:

(1) Ensure proper surgical care of chest tubes, surgical wounds, vascular access devices, and placement of invasive lines and tubes (arterial lines, Pulmonary Artery catheters, bladder catheters, nasogastric tubes and endotracheal tubes);

(2) Ensure disease diagnosis and treatment for arrhythmias, blood pressure abnormalities, and bleeding disorders;

(3) Order the proper tests for diagnosis;

(4) Refer to the appropriate specialists as necessary (pulmonary, cardiology, endocrine, infectious disease, other surgical subspecialties);

(5) Institute and monitor order sets which have become best practices (ventilator bundles, sepsis protocols, sedation protocols, line placement protocols, enteral feeding protocols, renal protection protocols);

(6) Provide for needed bedside surgical procedures such as placement of arterial lines, placement of central lines, chest tube insertion, placement of bladder catheters, placement of endotracheal tubes or a surgical airway, and bronchoscopy for diagnosis and treatment.

Education of Nonphysician Providers, Residents, and Medical Students

The director of the CVICU must encourage a culture of continuous quality improvement and continuing medical education. The director must maintain his own fund of knowledge that keeps up with the new advances now on the cutting edge of surgical critical care.

The CVICU director should be the educator of those working in the unit. Critical care training can be improved with daily teaching rounds incorporated into multidisciplinary work rounds. Improvements in physical exams, formation of differential diagnoses, order sets, procedures, and medical management can all be realized. An experienced cardiothoracic surgeon leading those rounds has become standard at many universities (Johns Hopkins, University of Michigan) and this would be a significant step for any medical center looking to maintain its leadership in Cardiac care in its community.

The emphasis on education is essential in nurse training and a surgeon committed to education would be important in both recruiting and retaining those nurses interested in cardiovascular intensive care.

Research Activity in the CVICU

The CVICU is an excellent place to conduct research pertinent to the care of the critically ill surgical patient. Models for the study of myocardial dysfunction, post-operative bleeding, transfusion management, end-organ dysfunction and the potential for studying genomic markers, new devices, and the creation of new databases for data extraction are all areas ripe for focused research; this research can be led by a surgeon with a research background.

Financial Justification for a Surgeon CVICU Director

Besides providing optimal care for the post-operative patient, the cardiothoracic CVICU intensivist can be a financial benefit for the hospital.

Any procedures done can be billed so long as the proper documentation is shown.

The intensivist, who is acting within his scope of practice, can independently report his professional services. There are numerous CPT Codes that can come into play. Examples are as follows:

(1) Airway management

Bronchoscopic procedures using flexible fiberoptic bronchoscopy (31622, 31624, 31625-29)

Tracheostomy (31600, 31601, 31603-05)

(2) Vascular access

Arterial lines (36620, 36625)

Central lines (36555, 36556)

(3) Mediastinal exploration for bleeding

Take-backs to the OR for post-op bleeding (39000-39010, 60505)

(4) Drainage of wound infections

I&D for superficial infections (35820)

Sternal debridement for deep infections (21627)

Re-wiring for sternal dehiscence (21740-21742, 21750)

(5) Drainage of pleural effusions

Percutaneous (32556)

VATS for evacuation and pleurodesis (32551, 32650)

VATS for decortication (32035, 32036)

(6) Drainage of pericardial effusions

Pericardial window; subxiphoid or thoracotomy (32659, 33025, 33020, 33017-19, 33016)

(7) Pacemaker placement and management (33206-33208)

(8) Swan-Ganz catheter placement (93503)

(9) Thoracostomy tube placement (32551)7

The above are just some of the areas where the surgeon intensivist can help lessen the workload of the main operative cardiothoracic surgeons.

In summary, endoscopic procedures, procedures on the lungs and pleura (VATS), pericardial procedures, temporary pacemakers, implantation of hemodynamic monitors, extracorporeal membrane oxygenation support devices, central venous and arterial access, are examples of procedures that can be done by the surgeon CVICU intensivist.

The generated billings of the CVICU surgeon director who is seeing patients in consultation can easily meet the costs associated with his salary and benefits. Billing accrued from tests ordered, notes written, and procedures done will further justify this position.

Conclusion

In conclusion, a cardiothoracic surgeon helping manage the CVICU is the “right operator, with the right information, making the right decision to use the right tool to perform the right task at the right time in the right manner.”8

“…[A]dvances have not been in improved hemodynamic monitoring, pharmacologic therapy, or understanding of the pathophysiology of the diseases unique to our patients, but rather improvements in the system of medical care delivery such as checklists and improving teamwork” has led to better results.9

Having a Cardiothoracic surgeon directing the CVICU is the national trend, and the time is right for medical centers that do cardiac and thoracic surgery to take this next step in maintaining surgical excellence in cardiovascular and thoracic care.


1 Guru V et al. Circulation, 117; 2969-2976, (2008). 2 Choi PS, Pines KC, Swaminathan A, et al. Diversifying cardiac intensive care unit models: Successful example of an operating surgeon led unit. (JTCVS Open 2023; 16, 524-31). 3 Whitman GJR, Haddad M, Hirose H, Allen JG, et al. Cardiothoracic Surgeon Management of Postoperative Cardiac Critical Care. Arch Surg/Vol 146 (No. 11) Nov 2011, 1253-60. 4 Sherif HMF: After-hours coverage of cardiothoracic critical care units by non-surgeons: process and value issues. European Journal of Cardio-Thoracic Surgery 46 (2014) 507. 5 Baumgartner W, Calhoon JH, Shemin RJ, Allen MS: Critical care: American Board of Thoracic Surgery update. The Journal of Thoracic and Cardiovascular Surgery, 145(6), 1448-9, (2013). 6 Id. 7 CPT 2024 Professional Edition. 8 Sharif HMF. Developing a curriculum for cardiothoracic surgical critical care: impetus and goals. Journal of Thoracic and Cardiovascular Surgery, 143(4), 804-8, (2012). 9 Shake JG, Pronovost PJ, Whitman G. Cardiac surgical ICU care: eliminating “preventable” complications. Journal of Cardiac Surgery, 28(4), 406-13, (2013).

Artificial Intelligence and its Role in Surgical Creativity

Darryl S. Weiman, M.D., J.D.
Associate Program Director, General Surgery Residency
Baptist Memorial Medical Education
Baptist Health Sciences University

Stephen W. Behrman, M.D.
Professor of Surgery and Chair
Baptist Memorial Medical Education
Baptist Health Sciences University

Department of Surgery, Baptist Medical Center, Memphis, TN

“It is tough to make predictions, especially about the future.” Yogi Berra, hall of fame catcher for the New York Yankees

              Based on numerous recent news accounts and several publications in the surgical literature, it is clear that “artificial intelligence” (AI) is positioned to make significant contributions in surgical care and training. AI uses algorithms which then allow computers to make predictions i.e., solve problems based on recognized words, clues seen on images, data collected, and applied statistics.

              Several companies are investing billions of dollars to solidify their spot in the AI market. Microsoft, Apple, Nvidia, Google (Alphabet Inc.), OpenAI, Amazon (Alexa), IBM, and xAI (Grok) are just a few of the companies that have made significant investments as the potential financial return is tremendous.

              The programming of the algorithms used in AI is not known and it is unlikely that they will be made available for review as this intellectual property is very valuable. Absent a change in the United States Constitution, these algorithms will be protected for some time.[1]

              What do we know about AI? It seems that the powerful computers in the AI realm absorb data from huge databases and use these databases to formulate predictions. But sometimes, the answers provided (predictions?) are not true. It may be that the databases used are faulty and thus the computers predictions are faulty. Garbage in, garbage out, so to speak.

              There are several articles that confirm AI platforms are making mistakes. Hiltzik described AI that provided lawyers with false precedents which the lawyers used in supporting their cases. When the judges found the precedents had not been checked by the lawyers, fines and other punishments were levied.[2] Also, a Texas professor recently flunked his whole class when an AI program erroneously accused all the students of plagiarism.[3]

              AI has already proven useful in diagnostic specialties where it can learn to recognize patterns and detect things by analyzing vast libraries of visual images and videos. Specialties such as radiology, pathology, and dermatology have shown that AI can review images and pick up on things that the physician may have missed. Could AI eventually be used to replace human physicians?

              This question was recently raised with a retired IBM executive. This executive assured us that Watson, the IBM AI representative, is meant to help us do our job better.[4] In the diagnostic specialties, this seemed to be a reasonable answer. We then asked if a computer could ever affect a surgeon’s creativity due to an overreliance on the AI direction? She was reluctant to make predictions on AI creativity.

              We then asked this question to Google, and this was the answer we were given:

                             “Concerns that AI could stifle a surgeon’s creative training by removing complex problem-solving are valid, though current research suggests a more nuanced outcome. AI is expected to serve as a supplementary tool in surgical training, automated standard tasks and providing realistic simulations, which can help accelerate skill acquisition. However, the human aspects of surgical creativity—including the ability to respond to unexpected intraoperative events and innovate new techniques—will remain critical for developing a surgeon’s full expertise.”[5]

              This issue of AI harming the knowledge, creativity, and skills of a surgeon was recently raised by Abiodun Adegbesan et. al. In this letter to the editor, this group states, “there is a danger that surgeons may become passive operators which can potentially lead to a reduction in their surgical dexterity, clinical expertise and overall problem-solving abilities.”[6] 

              ChatGPT is an advanced AI language model developed by OpenAI. It is a Generative Pre-trained Transformer that “learns” from internet data to perform tasks such as answering questions, summarizing information, and writing papers.

In a recent article by Keith Naunheim and Mark Ferguson, four popular chatbots were tested against 21 board-certified thoracic surgeons on ten clinical scenarios. The surgeons performed at a significantly higher level than the chatbots. In this study, the authors concluded that “[a]lthough they are becoming increasingly sophisticated, chatbots do not yet perform at the level of a practicing thoracic surgeon when faced with complex clinical scenarios.”[7] It would be interesting to see how the chatbots perform against thoracic surgical residents who have not yet garnered the experience of the certified surgeons.

In a world which has already seen computers beat human opponents at Jeopardy (IBM’s Watson)[8] and Grand Masters at Chess (IBM’s Deep Blue)[9], it is somewhat surprising that several chatbots were not able to outperform the board-certified thoracic surgeons in vignettes relating to well-known clinical scenarios. It is just a matter of time before the computer can surpass surgeons in making diagnoses and formulating treatment plans. But can the computer work with a robot to do operations independent of human control?

At this time, it is unlikely that a robot can be programmed to do operations as well as surgeons because robot arms and graspers are limited in their physical ability. Human hands are superior to any known robot platforms, but this difference is being challenged. At Northwestern University’s Center for Robotics and Biosystems, researchers are working on improving tactile sensing and flexibility of robotic hands.

Kevin Lynch, who leads Northwestern’s team working on robotic hands says, “the team has set a 10-year goal to achieve dexterity sufficient for basic humanlike tasks.”[10]

Engineers at Tesla are also working to improve their humanoid robot, Optimus, so that it will be capable of “performing the small, precise motions that define most skilled labor.”[11] As Elon Musk told the Wall Street Journal, “In order to have a useful generalized robot, you do need an incredible hand.”[12]

But what about the creativity element that is essential for any surgeon who may face a rapidly changing and challenging environment in the operating room? Can creativity be programmed into the AI platform?

Surgeons are not the only ones worried that AI may be harmful in training people whose creativity is paramount for job performance. In a military context, war gaming is essential in training intelligence professionals. A quote by President Dwight Eisenhower is on point, “Plans are worthless, but planning is everything.”[13]

              In a recent article from the Combating Terrorism Center at West Point, Nicholas Clark raised the issue that artificial intelligence may result in overreliance by Special Operators who need to be creative and quickly responsive to sudden changes on the battlefield. “While generative AI may assist in automating routine tasks, it lacks the capacity for nuanced judgment, uncertainty quantification, and dynamic responsiveness critical to effective CT work.”[14]

              “The use of generative AI for operational planning may, in fact, make our planners worse by removing the real benefits of the planning process and limit the CT forces’ ability to respond dynamically to branches and sequels.”[15]

              A recent study looked at brain activity when ChatGPT was used.  The study found that users of ChatGPT for helping to write papers became more dependent on the computer as the study progressed. As the users of ChatGPT became more dependent on the computer, the final papers became a copy and paste exercise.[16] There was no more creative input by the humans in writing the papers.

              Surgeons are very much like Special Operators. They must be studying and training constantly to keep up with the specialty; it is a learned profession. The main difference between Special Operators and surgeons is the surgeon knows he is likely to go home alive later in the day.

              But what about doing operations without human control. Could the surgical robots with AI platforms be programmed to do operations by themselves? Robotic operations are being done by humans around the world daily. The operations are being done with surgeons at a console, controlling the robot arms. So far, the critical difference is that the surgeon controls the robot arms and has hands which the robot does not. If things go bad, the surgeon can abort the robotic procedure and can open the patient and do the operation in the conventional way. But that difference may be changing.

              Can the computer be programmed to learn when it is over its head and abandon the robotic procedure? If faced with circumstances that are not answerable with the database provided (i.e. aberrant anatomy, arterial bleeding, hollow viscus injury, etc.), could the computer be creative and provide a solution? How can creativity be programmed? This is a difficult question because we do not know how to define “creativity”, and we do not understand the process of being creative in the first place.

              “ChatGPT runs on something called an artificial neural network, which is a type of AI modeled on the human brain. Instead of having a bunch of rules explicitly coded in like a traditional computer program, this kind of AI learns to detect and predict patterns over time…[But] because systems like this essentially teach themselves, it’s difficult to explain precisely how they work or what they’ll do. Which can lead to unpredictable and even risky scenarios as these programs become more ubiquitous…[AI is] trained…by basically doing autocomplete.”[17]

              When circumstances in the operating room change, the surgeon (at least now) generally has the knowledge, education, experience, and skills to adjust appropriately. He may need to call in a colleague and that is part of being a professional. Could AI act professionally and be creative if the circumstance calls for it? At our present state of knowledge, if creativity is required, it is unlikely that a computer can replace a human surgeon. However, as AI platforms continue to improve, they may enhance simulation exercises, but this should be extrapolated to live surgery with caution. As the retired IBM executive stated, AI computers are meant to help us, not replace us.

              Medical education and surgery are growing at a rapid pace. Being creative and using judgment to adapt to rapidly changing circumstances is often the difference between life and death. AI should only be used when its’ strengths outweigh its weaknesses. We must continue to train our surgeons to be creative and resourceful to better help our profession grow and keep us, at least one step ahead of AI and robots.

              The only part of this article that was AI generated was the answer to the question asked of Google above.



1 United States Constitution, Article I, Section 8, Clause 8. The Congress shall have Power…To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries[.]

[2] Runco MA. AI can only produce artificial creativity. Journal of Creativity 33 (2023) 100063.

[3] Id.

[4] Personal communication with IBM executive (anonymous).

[5] Response given by Google AI to the question on surgeon’s creativity being hampered by overreliance on AI.

[6] Adegbesan A, Akingbola A, Aremu O, et. al. From Scalpels to Algorithms: The Risk of Dependence on Artificial Intelligence in Surgery. Journal of Medicine, Surgery, and Public Health 3 (2024) 100140.

[7] Bryan DS, Platz JJ, Naunheim KS, Ferguson MK. How soon will surgeons become mere technicians? Chatbot performance in managing clinical scenarios. The Journal of Thoracic and Cardiovascular Surgery. Volume 170, number 4 1179-1184, 2025.

[8] Watson beat Brad Rutter and Ken Jennings to win a $1 million prize in 2011.

[9]  Deep Blue beat Gary Kasparov in 1997. Kasparov felt that cheating was involved since some of the computer’s moves were non-sensical. It turned out there were flaws in the programming which have since been fixed. Even with the programming errors, the computer still won.

[10] Jacobs S. Engineering the perfect robotic hand could unlock a $5 trillion humanoid market. Wall Street Journal, October 26, 2025.

[11] Id.

[12] Id.

[13] Eisenhower, D. Remarks at the National Defense Executive Reserve Conference, November 14, 1957.

[14] Clark N. Commentary: The Dangers of Overreliance on Generative AI in the CT Fight. CTC Sentinel, p. 15-19, August 2025.

[15] Id. p. 16.

[16] Nataliya Kosmyna et al., “Your brain on Chat GPT: Accumulation of cognitive debt when using an AI assistant for essay writing task,” arXiv.org, June 10, 2025.

[17] Runco MA Id. p. 5.

Medical Malpractice Legal Requirements May Be Changing

Darryl Weiman, M.D., J.D.

The American Law Institute (ALI) is a group of lawyers, judges, and other legal scholars whose mission is to improve, modernize, and clarify the law to promote the administration of justice. Established in1923, it is a private, independent, non-profit and their writings have great weight in the legal community. The ALI publishes Restatements of the Law, Principles of the Law, and Model Codes, to “express the law as it should be.”

In 2024, the American Law Institute (ALI) wrote new guidelines for medical malpractice which shifted from the “reasonable physician” to a more patient-centered standard which relied more on evidence-based practice guidelines. As mentioned above, these new standards have considerable respect in the legal community, and it is reasonable to conclude that some state legislatures and supreme courts will follow the recommendations to incorporate “evidence-based medicine” into malpractice law. This is a significant shift which may cause major legal problems for physicians.

Medical malpractice is currently predicated on the “reasonable practitioner” standard. Although there is variability among the states, a practitioner would not be liable for malpractice so long as their actions complied with what a reasonable provider would do if faced with the same or similar circumstances.

Here is an example of what might happen with the ALI recommended changes. I was at a continuing legal education meeting where the speaker, a well-known plaintiff’s attorney, stated that deviations from practice guidelines should be construed as medical malpractice. He used the example of the Advanced Cardiac Life Support (ACLS) acronym for the acute coronary syndrome. The acronym is MONA, which stands for morphine, oxygen, nitrates, and aspirin. According to this attorney, a physician who did not follow these guidelines is liable for malpractice if the patient was harmed.

As physicians, we all know not to give morphine to a patient with an allergy to that drug, and we may not be willing to give it to a patient with low blood pressure. We may be reluctant to start oxygen on a patient with severe chronic obstructive pulmonary disease, as the oxygen saturation may be his driver of respiration and providing oxygen may lead him to stop breathing. With similar reasoning, we may not give aspirin to a patient who is allergic to the drug or if gastrointestinal bleeding is an issue. Also, we know not to give nitrates to a patient who is taking Viagra or Cialis because, as the commercials warn us, this can cause a precipitous drop in blood pressure.

With current medical malpractice law, the burden of proof is on the plaintiff who must show, with a preponderance of the evidence standard, that the practitioner did not do what a “reasonable practitioner” would do if faced with the same or similar circumstances. If the recommendations of the ALI are to be used, the burden of proof would shift to the practitioner

who would need to convince the jury that the guidelines should not be applied in his case. This is a significant shift in burden.

Granted, the guidelines have disclaimers, usually at the beginning of the publication, which acknowledge that the guidelines are written for the ideal patient presenting with that disease entity and it is up the physician taking care of the patient to decide whether to use the guidelines. Plaintiffs are likely to downplay or ignore these disclaimers. The result will be to shift the burden of proof to the physician to convince a jury that following guidelines written by experts in the field was the wrong thing to do in his case. Good luck with that.

It becomes more problematic when it comes time for the judge to instruct the jury as to what standard of care it should use in deciding the case. Instead of customary care as the standard for reasonableness, the guidelines will be used to define what the law says is “reasonable.” It is foreseeable that the injured plaintiffs will use the guidelines as the best scientific evidence of what the physician should have done.

Expert witnesses for the defense used to opine whether the practitioner did what a reasonable practitioner would do if faced with the same or similar circumstances. That was the law. With the guidelines, by law, now defining the standard of care, defense experts will need to argue that the law should not be followed in this case. Under the “preponderance of the evidence” burden of proof needed in most malpractice actions, this may make it more difficult for the practitioner to win his case; juries instructed to follow the law, are unlikely to ignore that instruction.

Instead of practicing defensive medicine, physicians and other practitioners will be inclined to follow guidelines even though it is rare to find the ideal patient with any disease entity. Knowledge, education, training, experience, and skill will no longer be the lynchpins of medical judgment. Computers may soon be telling us how to take care of our patients. In fact, they already are.

If a practitioner decides not to follow the guidelines, he should document his reasoning in the medical records. With this documentation, the court will be inclined to believe that the physician was doing what he believed to be best for his patient, i.e., he was acting reasonably. This will go a long way in helping him win the case.

The Ethics of Self-Experimentation

By Darryl Weiman, M.D., J.D.

Newsletter from the Standards and Ethics Committee for the Eastern Cardiothoracic Surgical

In 1929, a first-year surgical resident, Werner Forssmann, operating on a dog, was able to insert a urologic catheter through a leg vein into the right atrium. The dog survived. Forssmann hypothesized that the same procedure could be done on humans. With a catheter placed in the right side of the heart, he could then study right sided pressures safely and could evaluate the effects of medicines, such as digoxin, injected directly into the heart.

Forssmann brought his idea to his boss and, not surprisingly, his proposal to place a central catheter in humans was rejected. Forssmann, convinced with the importance of cannulating the central circulation in humans, decided to place a catheter in himself. With the help of an operating room nurse, he obtained sterile instruments and with the nurse—who thought that she was to be the experimental subject—locked themselves into the hospital’s small operating room. Forssmann, then did a cutdown into a left arm vein and threaded a lubricated ureteral catheter 65 centimeters from the arm into his body.

Forssmann probably wanted the nurse to be with him in case something went wrong and probably never intended for her to be the subject of the procedure. Forssmann and the nurse then went to the radiology department where a chest radiograph confirmed the position of the catheter in the heart. The catheter was removed and there were no complications.

The next morning, Forssmann showed the radiograph to his boss who immediately fired him. Forssmann was able to get an unpaid appointment with Ferdinand Sauerbruch at the surgical department at the Charite in Germany. Forssmann’s ideas were ridiculed by his colleagues at Charite so he ended up going to the University Hospital in Mainz where he trained in urology.

From Mainz, he went to the Rudolf Virchow Hospital in Berlin for further training in urology and general surgery. After more training, World War II intervened and Forssmann was never able to fulfill his dream of being an academic surgeon.

Forssmann continued his career as a general practitioner and urologist until 1956 when he was informed that he had been awarded the Nobel Prize. From 1958 to his retirement in 1969, he was the Chair of the surgical division of the Evangelist Hospital in Dusseldorf.

History shows the importance of what Forssmann did to himself on that day in 1929. His Nobel co-recipients Andre Cournand and Dickinson Richards, intrigued by Forssmann’s article of 1929, pioneered the work leading to cardiac catheterization as we know today. Catheterization of the right heart led to study of the left heart and, subsequently, to coronary arteriography.

Percutaneous interventions to the coronary arteries and percutaneous interventions for valves are now being routinely done. Millions of lives have been saved due to the development of cardiac catheterization, but do the results justify the means? In this case, I think they do.

Self-experimentation is not new, and Forssmann is not the only Nobel Prize winner in medicine to do this. Barry Marshall was convinced that H. pylori was a cause of gastritis and ulcers. He drank a broth that contained the bacteria and got gastritis which he then cured with appropriate antibiotics. Marshall’s work changed the treatment of these diseases, and he was awarded the Nobel in 2005.

So what are we to make of those who self-experiment? After all, it is difficult to reconcile between reckless endangerment and heroic self-sacrifice. The ethical principles outlined and defined in the Belmont Report of 1979 are a reasonable starting point.

The three main principles of the Belmont Report are (1) respect for persons (autonomy), (2) beneficence/nonmaleficence, and (3) justice. Can we use these principles as guidelines to determine when self-experimentation is justified?

Under autonomy, it seems obvious that the self-experimenter is exercising his personal liberty, and he has probably given himself informed consent. No vulnerable population seems to be involved, and no person is being coerced. However, bias may lead to an underestimation of the risks. Without external oversight, safeguards may be underestimated or totally absent. Even Forssmann made sure his nurse was present in case something bad happened.

With beneficence/nonmaleficence, the goal is to maximize benefits and minimize risks. The self-experimenter is probably minimizing risk for others but, if the risk to himself is high and the hoped for benefit is low, then the experiment should not be condoned. In fact, if dealing with pathogens e.g., Covid, then risks could spread to the community at large especially if proper safeguards (containment?) are not in place.

Justice requires a fair distribution of research risks and benefits. If the self-experimenter bypasses the IRB review process then ethical standards are not considered which can hurt the justice of the whole research endeavor.

So what are we supposed to do? Pursuit of discovery should be encouraged but recklessness should not. Self-experimentation is a gray zone of modern ethics, and the debate is on-going so do not expect an answer from me. However, safeguards should be placed by the IRB and by journals who may be asked to support and publish the results of the experiment.

Remember, Forssmann was able to publish his experiment, and we can still view the chest radiograph he took in 1929, but that happened long before safeguards for human experimentation were in place. Each IRB and journal should balance the value of the knowledge sought, the risks involved, the safeguards in place, and the effect the experiment is setting for future researchers; these should all be part of the decision-making process.

Journals should only publish reports that can be morally justified. Reports should be judged on a case-by-case basis by ethical review boards and by the journal’s editors. Having a decision-making process already in place will go a long way in justifying publication of a self-experimenter’s report.