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When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.

“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.

Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.

He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”

The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.

Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.

More than half of the respondents not using AI said they first want more evidence that the technology works as intended.

“None of them work as advertised,” said one respondent.

MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.

Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.

Doctors may also be skeptical of AI based on their experience with EHRs, she said.

“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
 

Drawing the line at patient care

Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.

“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.

Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:

• Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
• Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
• Improving billing operations and predictive analytics.

Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.

They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
 

Is regulation needed?

Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.

“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.

In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.

Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.

In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.

There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
 

What should doctors do?

Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.

There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.

“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.

Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
 

A version of this article appeared on Medscape.com.

When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.

“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.

Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.

He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”

The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.

Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.

More than half of the respondents not using AI said they first want more evidence that the technology works as intended.

“None of them work as advertised,” said one respondent.

MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.

Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.

Doctors may also be skeptical of AI based on their experience with EHRs, she said.

“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
 

Drawing the line at patient care

Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.

“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.

Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:

• Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
• Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
• Improving billing operations and predictive analytics.

Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.

They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
 

Is regulation needed?

Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.

“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.

In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.

Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.

In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.

There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
 

What should doctors do?

Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.

There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.

“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.

Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
 

A version of this article appeared on Medscape.com.

When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.

“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.

Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.

He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”

The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.

Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.

More than half of the respondents not using AI said they first want more evidence that the technology works as intended.

“None of them work as advertised,” said one respondent.

MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.

Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.

Doctors may also be skeptical of AI based on their experience with EHRs, she said.

“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
 

Drawing the line at patient care

Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.

“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.

Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:

• Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
• Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
• Improving billing operations and predictive analytics.

Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.

They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
 

Is regulation needed?

Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.

“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.

In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.

Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.

In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.

There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
 

What should doctors do?

Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.

There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.

“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.

Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
 

A version of this article appeared on Medscape.com.

After her emergency medicine group was acquired by a staffing firm backed by a large private equity (PE) firm, Michelle Wiener, MD, said the workflow changes came swiftly.

“Our staffing has been greatly reduced,” the Detroit physician said. “At this point, we have no say in anything. We have no say in the scheduling. We aren’t allowed to see what is billed under our name. The morale has really gone down.”

Dr. Wiener, who practices at Ascension St. John Hospital, said she and fellow physicians have repeatedly brought their concerns to TeamHealth, which in 2015 took over St. John Emergency Services PC. TeamHealth is owned by PE giant Blackstone.

“It’s very frustrating,” Dr. Wiener said. “We’re taking it from all sides.”

Blackstone and Ascension St. John did not respond to this news organization’s request for comment.

TeamHealth would not respond directly to questions about the Ascension St. John Hospital physicians or their concerns.

Spokesman Josh Hopson provided only a general statement: “TeamHealth is committed to making sure that clinicians have the resources and support needed to provide first-class care to patients, particularly with regard to staffing and compensation. TeamHealth has and will always put patient care first, and that is not impacted by its ownership model.”

Acquisitions of medical practices and hospitals by PE firms are rapidly growing, with more than 1,400 PE deals in health care in 2021 totaling upwards of $208 billion, according to PitchBook Data Inc., a Seattle-based firm that tracks mergers and acquisitions.

Some physicians praise the partnerships as an opportunity to improve technology and efficiency, whereas others decry them as raising patient costs and lowering the quality of care. A recent UC Berkeley study found that PE ownership of medical practices was linked to consumer price increases for 8 of 10 specialties, most notably oncology and gastroenterology.
 

What should you expect after PE acquisition?

Since his practice partnered with a PE firm in 2020, Milwaukee-based otolaryngologist Madan Kandula, MD, said he has found the changes positive. The practice has grown and improved operations in finance, accounting, compliance, and information technology, said Dr. Kandula, founder and CEO of Advent, an ENT practice with 15 clinics in four Midwestern states.

Dr. Kandula said his group already had a sound business practice, and that the goal of partnering with a PE firm wasn’t to change day-to-day operations but to propel the organization forward.

“From patient load to visit time to how we staff our clinics, there has been no change,” he said. “My private equity firm does not, [and] cannot, impose their will on our clinical decisions.”

Experts say the impact of PE acquisitions on individual physicians often depends on where a doctor ranks in the organization, what stage they are in their career, and how much control they had over the deal.

“It’s the older physicians who are usually selling the practice and getting the big payout,” said Anjali Dooley, a St. Louis–based health law attorney who counsels physicians about PE deals. “The younger doctors are usually not part of the deal, as they may still be employees. They don’t have any negotiating power. Hopefully, there is some transparency, but sometimes there is not, and they are blindsided by the deal.”

When it comes to workload, most PE-owned groups are put on a production-based model, such as a wRVU-based model, said Roger Strode, a Chicago-based health law attorney who focuses on health care mergers and acquisitions. Most already operate under such a model, but there might be some changes after a buyout.

Staffing may also change, added Ms. Dooley. The PE firms may want to add partners or companies already in their portfolios to create efficiencies, causing training or workflow changes.

In a hospital buyout, changes may depend on whether a department is a significant revenue generator for the hospital, Ms. Dooley noted.

PE firms frequently favor higher revenue–generating specialties, such as neurosurgery, cardiology, orthopedics, gastroenterology, and plastic surgery. They closely scrutinize departments said that make less money, such as the emergency department or primary care, Ms. Dooley said. Physicians or teams that don’t fit the firm’s cost-efficiency plans may be terminated or replaced.

On the other hand, Mr. Strode said physicians may see improved electronic health records and collections.

“Some of your overall overhead costs may be reduced, because they’re better at it,” Mr. Strode said. “When you’ve got more scale, the cost per patient, the cost per hour, the cost per procedure, goes down, and the cost that’s applied against your production will go down. As [practices grow], they have more bargaining power with payers and you can potentially get better rates. At least, that’s the promise.”

Analysts note that PE health care acquisitions show no signs of slowing and that it pays for physicians to know what to expect and how to cope if their practice or hospital is acquired. Whether physicians have some control over a buyout or are blindsided by the transition, it’s critical to know what to consider, how workloads might change, and your options for settling in or settling up.

The PE industry has about $2 trillion lined up for potential investments in 2023, said Ms. Dooley.

“PE firms are looking at health care to expend some of this dry powder,” Ms. Dooley continued. “If done correctly, PE firms that are aware of health care regulations, compliance, and patient care issues can ... remove redundant services and improve ... efficiencies, but the bad is when that doesn’t happen, and the quality of care goes down or there are patient safety risks.”
 

How to prepare for and cope with PE partnerships

If your practice is considering a PE partnership, it’s important to explore the terms and conditions and carefully weigh the pros and cons, said Gary Herschman, a Newark, N.J.–based attorney who advises PE-owned physician groups.

“My recommendation is that physicians at a minimum conduct due diligence on all potential strategic options for their groups, and then make an informed decision regarding whether a partnership transaction is right for their group, as it’s not right for every group,” he said.

When Texas cardiologist Rick Snyder, MD, was considering PE partnerships, he spoke with physicians who made similar deals to determine whether they were satisfied years later, he said. In April, Snyder’s practice, HeartPlace, the largest physician-owned cardiology practice in Texas, was acquired by US Heart & Vascular, a practice management platform backed by PE firm Ares Management.

“I called every group that I knew that had done private equity for any meaningful amount of time,” Dr. Snyder said. “For the first year or two, everybody is in the honeymoon period. If the model is going to succeed or break down, it’s not going to be in the first year or two. So I wanted to talk to groups that had done this for a longer amount of time and find out what their pitfalls were. What would they have done differently? Has it been a productive relationship? Did they grow?”

Dr. Snyder, president of the Texas Medical Association, said his practice met with seven or eight firms before choosing one that best met their needs. His group wanted a platform that preserved their clinical autonomy, governance, and culture, he said. They also wanted to ensure they were not entering into a “buy and flip” scenario, but rather a “buy and build” plan.

“Thus, financial capital was not sufficient, they also had to have intellectual capital and relationship capital on their bench,” he said. “When we found the partner that embraced all of these factors as well as a history of buying and long-term building, we pulled the trigger and partnered with Ares and US Heart & Vascular Management. The partner we chose did not offer us the most money. We put a premium on these other criteria.”

“I always tell docs, know the culture of your group and your vision,” he said. “Before you go down that route, ask yourself what you want to accomplish and if it makes sense having a private equity partner to accomplish that vision with.”

For younger physicians or those with little control over buyouts, experts recommend they review their contracts and consider consulting with an attorney to better understand how the deal may affect their earnings and career prospects.

Those who have a much longer career runway need to weigh whether they want to work for a PE-linked practice, Mr. Strode said. For some, it’s time to check when their noncompete agreements end and find a position elsewhere.

Also, physicians should know their rights and the laws in their states regarding the corporate practice of medicine. Statutes vary by state, and knowing the provisions in your state helps doctors recognize their legal rights, learn possible exceptions to the requirements, and know the penalties for violations.

In Michigan, a group of physicians and other health professionals at Ascension St. John has voted to unionize. Doctors hope that the union, which includes advanced practice clinicians, nurse practitioners, and physician assistants, will help improve patient care and protect working conditions for staff, Dr. Wiener said.

She advises physicians who are unhappy after acquisitions to speak up and stick together.

“That’s the biggest thing I think physicians should start doing,” she said. “Support each other and stand up. You are stronger together.”
 

Why is PE so attracted to health care?

PE firms typically buy practices or hospitals, work to make the entities more profitable, and then sell them, with the goal of doubling or tripling their investment over a short period. In general, PE firms aim for annual returns exceeding 20% after 3-7 years.

These firms know that health care is relatively recession-proof, that providers have third-party payers, and that the industry is fragmented and requires more efficiency, Ms. Dooley said.

When PE practice acquisitions started gaining momentum about 12 years ago, traditional hospital-based specialties such as anesthesiology and radiology were prime targets, said Mr. Strode.

At the same time, increasing challenges in private practice, such as declining compensation from payers, pressure to participate in value-based care programs, and rising regional competitors have fueled more physician groups to partner with PE firms, Mr. Herschman noted.

Physicians who partner with PE firms often benefit by having new access to capital to grow their practices, cost savings through group purchasing, and the ability to compete with larger health groups, Mr. Herschman said.

Questions remain, however, about how PE involvement affects health care use and spending. An April 2023 JAMA Viewpoint article called out the lack of oversight and regulation in the health care/PE space, suggesting that a stronger framework for regulation and transparency is needed.

A 2022 study in JAMA Health Forum that examined changes in prices and utilization associated with the PE acquisitions of 578 dermatology, gastroenterology, and ophthalmology physician practices from 2016 to 2020 found that prices increased by an average of 11%, and volume rose by 16%, after acquisition.

“We found that acquisitions were associated with increases in health care spending and utilization, as well as some other patterns of care like potential upcoding,” said Jane M. Zhu, MD, an author of the study and assistant professor at Oregon Health & Science University in Portland.

Another recent study that Dr. Zhu coauthored, published in Health Affairs, found that physician practices acquired by PE firms experience greater staff turnover and rely more heavily on advanced practice professionals than doctors.

“To the extent that that turnover indicates physicians are dissatisfied after private equity comes in, that’s really important to investigate further,” Dr. Zhu said.

PE firms owned 4% of U.S. hospitals in 2021 and 11% of nursing homes, according to a Medicare Payment Advisory Commission (MedPAC) report. The report does not include 2021 data on medical practices but notes that from 2013 to 2016, PE firms acquired at least 2% of physician practices. Estimates of PE deals are probably lower than actual numbers because of the lack of comprehensive information sources, according to the MedPAC report.

A version of this article appeared on Medscape.com.

After her emergency medicine group was acquired by a staffing firm backed by a large private equity (PE) firm, Michelle Wiener, MD, said the workflow changes came swiftly.

“Our staffing has been greatly reduced,” the Detroit physician said. “At this point, we have no say in anything. We have no say in the scheduling. We aren’t allowed to see what is billed under our name. The morale has really gone down.”

Dr. Wiener, who practices at Ascension St. John Hospital, said she and fellow physicians have repeatedly brought their concerns to TeamHealth, which in 2015 took over St. John Emergency Services PC. TeamHealth is owned by PE giant Blackstone.

“It’s very frustrating,” Dr. Wiener said. “We’re taking it from all sides.”

Blackstone and Ascension St. John did not respond to this news organization’s request for comment.

TeamHealth would not respond directly to questions about the Ascension St. John Hospital physicians or their concerns.

Spokesman Josh Hopson provided only a general statement: “TeamHealth is committed to making sure that clinicians have the resources and support needed to provide first-class care to patients, particularly with regard to staffing and compensation. TeamHealth has and will always put patient care first, and that is not impacted by its ownership model.”

Acquisitions of medical practices and hospitals by PE firms are rapidly growing, with more than 1,400 PE deals in health care in 2021 totaling upwards of $208 billion, according to PitchBook Data Inc., a Seattle-based firm that tracks mergers and acquisitions.

Some physicians praise the partnerships as an opportunity to improve technology and efficiency, whereas others decry them as raising patient costs and lowering the quality of care. A recent UC Berkeley study found that PE ownership of medical practices was linked to consumer price increases for 8 of 10 specialties, most notably oncology and gastroenterology.
 

What should you expect after PE acquisition?

Since his practice partnered with a PE firm in 2020, Milwaukee-based otolaryngologist Madan Kandula, MD, said he has found the changes positive. The practice has grown and improved operations in finance, accounting, compliance, and information technology, said Dr. Kandula, founder and CEO of Advent, an ENT practice with 15 clinics in four Midwestern states.

Dr. Kandula said his group already had a sound business practice, and that the goal of partnering with a PE firm wasn’t to change day-to-day operations but to propel the organization forward.

“From patient load to visit time to how we staff our clinics, there has been no change,” he said. “My private equity firm does not, [and] cannot, impose their will on our clinical decisions.”

Experts say the impact of PE acquisitions on individual physicians often depends on where a doctor ranks in the organization, what stage they are in their career, and how much control they had over the deal.

“It’s the older physicians who are usually selling the practice and getting the big payout,” said Anjali Dooley, a St. Louis–based health law attorney who counsels physicians about PE deals. “The younger doctors are usually not part of the deal, as they may still be employees. They don’t have any negotiating power. Hopefully, there is some transparency, but sometimes there is not, and they are blindsided by the deal.”

When it comes to workload, most PE-owned groups are put on a production-based model, such as a wRVU-based model, said Roger Strode, a Chicago-based health law attorney who focuses on health care mergers and acquisitions. Most already operate under such a model, but there might be some changes after a buyout.

Staffing may also change, added Ms. Dooley. The PE firms may want to add partners or companies already in their portfolios to create efficiencies, causing training or workflow changes.

In a hospital buyout, changes may depend on whether a department is a significant revenue generator for the hospital, Ms. Dooley noted.

PE firms frequently favor higher revenue–generating specialties, such as neurosurgery, cardiology, orthopedics, gastroenterology, and plastic surgery. They closely scrutinize departments said that make less money, such as the emergency department or primary care, Ms. Dooley said. Physicians or teams that don’t fit the firm’s cost-efficiency plans may be terminated or replaced.

On the other hand, Mr. Strode said physicians may see improved electronic health records and collections.

“Some of your overall overhead costs may be reduced, because they’re better at it,” Mr. Strode said. “When you’ve got more scale, the cost per patient, the cost per hour, the cost per procedure, goes down, and the cost that’s applied against your production will go down. As [practices grow], they have more bargaining power with payers and you can potentially get better rates. At least, that’s the promise.”

Analysts note that PE health care acquisitions show no signs of slowing and that it pays for physicians to know what to expect and how to cope if their practice or hospital is acquired. Whether physicians have some control over a buyout or are blindsided by the transition, it’s critical to know what to consider, how workloads might change, and your options for settling in or settling up.

The PE industry has about $2 trillion lined up for potential investments in 2023, said Ms. Dooley.

“PE firms are looking at health care to expend some of this dry powder,” Ms. Dooley continued. “If done correctly, PE firms that are aware of health care regulations, compliance, and patient care issues can ... remove redundant services and improve ... efficiencies, but the bad is when that doesn’t happen, and the quality of care goes down or there are patient safety risks.”
 

How to prepare for and cope with PE partnerships

If your practice is considering a PE partnership, it’s important to explore the terms and conditions and carefully weigh the pros and cons, said Gary Herschman, a Newark, N.J.–based attorney who advises PE-owned physician groups.

“My recommendation is that physicians at a minimum conduct due diligence on all potential strategic options for their groups, and then make an informed decision regarding whether a partnership transaction is right for their group, as it’s not right for every group,” he said.

When Texas cardiologist Rick Snyder, MD, was considering PE partnerships, he spoke with physicians who made similar deals to determine whether they were satisfied years later, he said. In April, Snyder’s practice, HeartPlace, the largest physician-owned cardiology practice in Texas, was acquired by US Heart & Vascular, a practice management platform backed by PE firm Ares Management.

“I called every group that I knew that had done private equity for any meaningful amount of time,” Dr. Snyder said. “For the first year or two, everybody is in the honeymoon period. If the model is going to succeed or break down, it’s not going to be in the first year or two. So I wanted to talk to groups that had done this for a longer amount of time and find out what their pitfalls were. What would they have done differently? Has it been a productive relationship? Did they grow?”

Dr. Snyder, president of the Texas Medical Association, said his practice met with seven or eight firms before choosing one that best met their needs. His group wanted a platform that preserved their clinical autonomy, governance, and culture, he said. They also wanted to ensure they were not entering into a “buy and flip” scenario, but rather a “buy and build” plan.

“Thus, financial capital was not sufficient, they also had to have intellectual capital and relationship capital on their bench,” he said. “When we found the partner that embraced all of these factors as well as a history of buying and long-term building, we pulled the trigger and partnered with Ares and US Heart & Vascular Management. The partner we chose did not offer us the most money. We put a premium on these other criteria.”

“I always tell docs, know the culture of your group and your vision,” he said. “Before you go down that route, ask yourself what you want to accomplish and if it makes sense having a private equity partner to accomplish that vision with.”

For younger physicians or those with little control over buyouts, experts recommend they review their contracts and consider consulting with an attorney to better understand how the deal may affect their earnings and career prospects.

Those who have a much longer career runway need to weigh whether they want to work for a PE-linked practice, Mr. Strode said. For some, it’s time to check when their noncompete agreements end and find a position elsewhere.

Also, physicians should know their rights and the laws in their states regarding the corporate practice of medicine. Statutes vary by state, and knowing the provisions in your state helps doctors recognize their legal rights, learn possible exceptions to the requirements, and know the penalties for violations.

In Michigan, a group of physicians and other health professionals at Ascension St. John has voted to unionize. Doctors hope that the union, which includes advanced practice clinicians, nurse practitioners, and physician assistants, will help improve patient care and protect working conditions for staff, Dr. Wiener said.

She advises physicians who are unhappy after acquisitions to speak up and stick together.

“That’s the biggest thing I think physicians should start doing,” she said. “Support each other and stand up. You are stronger together.”
 

Why is PE so attracted to health care?

PE firms typically buy practices or hospitals, work to make the entities more profitable, and then sell them, with the goal of doubling or tripling their investment over a short period. In general, PE firms aim for annual returns exceeding 20% after 3-7 years.

These firms know that health care is relatively recession-proof, that providers have third-party payers, and that the industry is fragmented and requires more efficiency, Ms. Dooley said.

When PE practice acquisitions started gaining momentum about 12 years ago, traditional hospital-based specialties such as anesthesiology and radiology were prime targets, said Mr. Strode.

At the same time, increasing challenges in private practice, such as declining compensation from payers, pressure to participate in value-based care programs, and rising regional competitors have fueled more physician groups to partner with PE firms, Mr. Herschman noted.

Physicians who partner with PE firms often benefit by having new access to capital to grow their practices, cost savings through group purchasing, and the ability to compete with larger health groups, Mr. Herschman said.

Questions remain, however, about how PE involvement affects health care use and spending. An April 2023 JAMA Viewpoint article called out the lack of oversight and regulation in the health care/PE space, suggesting that a stronger framework for regulation and transparency is needed.

A 2022 study in JAMA Health Forum that examined changes in prices and utilization associated with the PE acquisitions of 578 dermatology, gastroenterology, and ophthalmology physician practices from 2016 to 2020 found that prices increased by an average of 11%, and volume rose by 16%, after acquisition.

“We found that acquisitions were associated with increases in health care spending and utilization, as well as some other patterns of care like potential upcoding,” said Jane M. Zhu, MD, an author of the study and assistant professor at Oregon Health & Science University in Portland.

Another recent study that Dr. Zhu coauthored, published in Health Affairs, found that physician practices acquired by PE firms experience greater staff turnover and rely more heavily on advanced practice professionals than doctors.

“To the extent that that turnover indicates physicians are dissatisfied after private equity comes in, that’s really important to investigate further,” Dr. Zhu said.

PE firms owned 4% of U.S. hospitals in 2021 and 11% of nursing homes, according to a Medicare Payment Advisory Commission (MedPAC) report. The report does not include 2021 data on medical practices but notes that from 2013 to 2016, PE firms acquired at least 2% of physician practices. Estimates of PE deals are probably lower than actual numbers because of the lack of comprehensive information sources, according to the MedPAC report.

A version of this article appeared on Medscape.com.

After her emergency medicine group was acquired by a staffing firm backed by a large private equity (PE) firm, Michelle Wiener, MD, said the workflow changes came swiftly.

“Our staffing has been greatly reduced,” the Detroit physician said. “At this point, we have no say in anything. We have no say in the scheduling. We aren’t allowed to see what is billed under our name. The morale has really gone down.”

Dr. Wiener, who practices at Ascension St. John Hospital, said she and fellow physicians have repeatedly brought their concerns to TeamHealth, which in 2015 took over St. John Emergency Services PC. TeamHealth is owned by PE giant Blackstone.

“It’s very frustrating,” Dr. Wiener said. “We’re taking it from all sides.”

Blackstone and Ascension St. John did not respond to this news organization’s request for comment.

TeamHealth would not respond directly to questions about the Ascension St. John Hospital physicians or their concerns.

Spokesman Josh Hopson provided only a general statement: “TeamHealth is committed to making sure that clinicians have the resources and support needed to provide first-class care to patients, particularly with regard to staffing and compensation. TeamHealth has and will always put patient care first, and that is not impacted by its ownership model.”

Acquisitions of medical practices and hospitals by PE firms are rapidly growing, with more than 1,400 PE deals in health care in 2021 totaling upwards of $208 billion, according to PitchBook Data Inc., a Seattle-based firm that tracks mergers and acquisitions.

Some physicians praise the partnerships as an opportunity to improve technology and efficiency, whereas others decry them as raising patient costs and lowering the quality of care. A recent UC Berkeley study found that PE ownership of medical practices was linked to consumer price increases for 8 of 10 specialties, most notably oncology and gastroenterology.
 

What should you expect after PE acquisition?

Since his practice partnered with a PE firm in 2020, Milwaukee-based otolaryngologist Madan Kandula, MD, said he has found the changes positive. The practice has grown and improved operations in finance, accounting, compliance, and information technology, said Dr. Kandula, founder and CEO of Advent, an ENT practice with 15 clinics in four Midwestern states.

Dr. Kandula said his group already had a sound business practice, and that the goal of partnering with a PE firm wasn’t to change day-to-day operations but to propel the organization forward.

“From patient load to visit time to how we staff our clinics, there has been no change,” he said. “My private equity firm does not, [and] cannot, impose their will on our clinical decisions.”

Experts say the impact of PE acquisitions on individual physicians often depends on where a doctor ranks in the organization, what stage they are in their career, and how much control they had over the deal.

“It’s the older physicians who are usually selling the practice and getting the big payout,” said Anjali Dooley, a St. Louis–based health law attorney who counsels physicians about PE deals. “The younger doctors are usually not part of the deal, as they may still be employees. They don’t have any negotiating power. Hopefully, there is some transparency, but sometimes there is not, and they are blindsided by the deal.”

When it comes to workload, most PE-owned groups are put on a production-based model, such as a wRVU-based model, said Roger Strode, a Chicago-based health law attorney who focuses on health care mergers and acquisitions. Most already operate under such a model, but there might be some changes after a buyout.

Staffing may also change, added Ms. Dooley. The PE firms may want to add partners or companies already in their portfolios to create efficiencies, causing training or workflow changes.

In a hospital buyout, changes may depend on whether a department is a significant revenue generator for the hospital, Ms. Dooley noted.

PE firms frequently favor higher revenue–generating specialties, such as neurosurgery, cardiology, orthopedics, gastroenterology, and plastic surgery. They closely scrutinize departments said that make less money, such as the emergency department or primary care, Ms. Dooley said. Physicians or teams that don’t fit the firm’s cost-efficiency plans may be terminated or replaced.

On the other hand, Mr. Strode said physicians may see improved electronic health records and collections.

“Some of your overall overhead costs may be reduced, because they’re better at it,” Mr. Strode said. “When you’ve got more scale, the cost per patient, the cost per hour, the cost per procedure, goes down, and the cost that’s applied against your production will go down. As [practices grow], they have more bargaining power with payers and you can potentially get better rates. At least, that’s the promise.”

Analysts note that PE health care acquisitions show no signs of slowing and that it pays for physicians to know what to expect and how to cope if their practice or hospital is acquired. Whether physicians have some control over a buyout or are blindsided by the transition, it’s critical to know what to consider, how workloads might change, and your options for settling in or settling up.

The PE industry has about $2 trillion lined up for potential investments in 2023, said Ms. Dooley.

“PE firms are looking at health care to expend some of this dry powder,” Ms. Dooley continued. “If done correctly, PE firms that are aware of health care regulations, compliance, and patient care issues can ... remove redundant services and improve ... efficiencies, but the bad is when that doesn’t happen, and the quality of care goes down or there are patient safety risks.”
 

How to prepare for and cope with PE partnerships

If your practice is considering a PE partnership, it’s important to explore the terms and conditions and carefully weigh the pros and cons, said Gary Herschman, a Newark, N.J.–based attorney who advises PE-owned physician groups.

“My recommendation is that physicians at a minimum conduct due diligence on all potential strategic options for their groups, and then make an informed decision regarding whether a partnership transaction is right for their group, as it’s not right for every group,” he said.

When Texas cardiologist Rick Snyder, MD, was considering PE partnerships, he spoke with physicians who made similar deals to determine whether they were satisfied years later, he said. In April, Snyder’s practice, HeartPlace, the largest physician-owned cardiology practice in Texas, was acquired by US Heart & Vascular, a practice management platform backed by PE firm Ares Management.

“I called every group that I knew that had done private equity for any meaningful amount of time,” Dr. Snyder said. “For the first year or two, everybody is in the honeymoon period. If the model is going to succeed or break down, it’s not going to be in the first year or two. So I wanted to talk to groups that had done this for a longer amount of time and find out what their pitfalls were. What would they have done differently? Has it been a productive relationship? Did they grow?”

Dr. Snyder, president of the Texas Medical Association, said his practice met with seven or eight firms before choosing one that best met their needs. His group wanted a platform that preserved their clinical autonomy, governance, and culture, he said. They also wanted to ensure they were not entering into a “buy and flip” scenario, but rather a “buy and build” plan.

“Thus, financial capital was not sufficient, they also had to have intellectual capital and relationship capital on their bench,” he said. “When we found the partner that embraced all of these factors as well as a history of buying and long-term building, we pulled the trigger and partnered with Ares and US Heart & Vascular Management. The partner we chose did not offer us the most money. We put a premium on these other criteria.”

“I always tell docs, know the culture of your group and your vision,” he said. “Before you go down that route, ask yourself what you want to accomplish and if it makes sense having a private equity partner to accomplish that vision with.”

For younger physicians or those with little control over buyouts, experts recommend they review their contracts and consider consulting with an attorney to better understand how the deal may affect their earnings and career prospects.

Those who have a much longer career runway need to weigh whether they want to work for a PE-linked practice, Mr. Strode said. For some, it’s time to check when their noncompete agreements end and find a position elsewhere.

Also, physicians should know their rights and the laws in their states regarding the corporate practice of medicine. Statutes vary by state, and knowing the provisions in your state helps doctors recognize their legal rights, learn possible exceptions to the requirements, and know the penalties for violations.

In Michigan, a group of physicians and other health professionals at Ascension St. John has voted to unionize. Doctors hope that the union, which includes advanced practice clinicians, nurse practitioners, and physician assistants, will help improve patient care and protect working conditions for staff, Dr. Wiener said.

She advises physicians who are unhappy after acquisitions to speak up and stick together.

“That’s the biggest thing I think physicians should start doing,” she said. “Support each other and stand up. You are stronger together.”
 

Why is PE so attracted to health care?

PE firms typically buy practices or hospitals, work to make the entities more profitable, and then sell them, with the goal of doubling or tripling their investment over a short period. In general, PE firms aim for annual returns exceeding 20% after 3-7 years.

These firms know that health care is relatively recession-proof, that providers have third-party payers, and that the industry is fragmented and requires more efficiency, Ms. Dooley said.

When PE practice acquisitions started gaining momentum about 12 years ago, traditional hospital-based specialties such as anesthesiology and radiology were prime targets, said Mr. Strode.

At the same time, increasing challenges in private practice, such as declining compensation from payers, pressure to participate in value-based care programs, and rising regional competitors have fueled more physician groups to partner with PE firms, Mr. Herschman noted.

Physicians who partner with PE firms often benefit by having new access to capital to grow their practices, cost savings through group purchasing, and the ability to compete with larger health groups, Mr. Herschman said.

Questions remain, however, about how PE involvement affects health care use and spending. An April 2023 JAMA Viewpoint article called out the lack of oversight and regulation in the health care/PE space, suggesting that a stronger framework for regulation and transparency is needed.

A 2022 study in JAMA Health Forum that examined changes in prices and utilization associated with the PE acquisitions of 578 dermatology, gastroenterology, and ophthalmology physician practices from 2016 to 2020 found that prices increased by an average of 11%, and volume rose by 16%, after acquisition.

“We found that acquisitions were associated with increases in health care spending and utilization, as well as some other patterns of care like potential upcoding,” said Jane M. Zhu, MD, an author of the study and assistant professor at Oregon Health & Science University in Portland.

Another recent study that Dr. Zhu coauthored, published in Health Affairs, found that physician practices acquired by PE firms experience greater staff turnover and rely more heavily on advanced practice professionals than doctors.

“To the extent that that turnover indicates physicians are dissatisfied after private equity comes in, that’s really important to investigate further,” Dr. Zhu said.

PE firms owned 4% of U.S. hospitals in 2021 and 11% of nursing homes, according to a Medicare Payment Advisory Commission (MedPAC) report. The report does not include 2021 data on medical practices but notes that from 2013 to 2016, PE firms acquired at least 2% of physician practices. Estimates of PE deals are probably lower than actual numbers because of the lack of comprehensive information sources, according to the MedPAC report.

A version of this article appeared on Medscape.com.

Sunday night. Las Vegas. Jason Aldean had just started playing.

My wife and I were at the 2017 Route 91 Harvest Festival with three other couples; two of them were our close friends. We were sitting in the VIP section, a tented area right next to the stage. We started hearing what I was convinced were fireworks.

I’ve been in the Army for 20 some years. I’ve been deployed and shot at multiple times. But these shots were far away. And you don’t expect people to be shooting at you at a concert.

I was on the edge of the VIP area, so I could see around the corner of the tent. I looked up at the Mandalay Bay and saw the muzzle flash in the hotel window. That’s when I knew.

I screamed: “Somebody’s shooting at us! Everybody get down!”

It took a while for people to realize what was going on. When the first couple volleys sprayed into the crowd, nobody understood. But once enough people had been hit and dropped, everyone knew, and it was just mass exodus.

People screamed and ran everywhere. Some of them tried to jump over the front barrier so they could get underneath the stage. Others were trying to pick up loved ones who’d been shot.

The next 15 minutes are a little foggy. I was helping my wife and the people around us to get down. Funny things come back to you afterward. One of my friends was carrying a 16-ounce beer in his hand. Somebody’s shooting at him and he’s walking around with his beer like he’s afraid to put it down. It was so surreal.

We got everybody underneath the tent, and then we just sat there. There would be shooting and then a pause. You’d think it was over. And then there would be more shooting and another pause. It felt like it never was going to stop.

After a short period of time, somebody came in with an official badge, maybe FBI, who knows. They said: “Okay, everybody up. We’ve got to get you out of here.” So, we all got up and headed across the stage. The gate they were taking us to was in full view of the shooter, so it wasn’t very safe.

As I got up, I looked out at the field. Bodies were scattered everywhere. I’m a trauma surgeon by trade. I couldn’t just leave.

I told my two best friends to take my wife with them. My wife lost her mind at that point. She didn’t want me to run out on the field. But I had to. I saw the injured and they needed help. Another buddy and I jumped over the fence and started taking care of people.

The feeling of being out on the field was one of complete frustration. I was in sandals, shorts, and a t-shirt. We had no stretchers, no medical supplies, no nothing. I didn’t have a belt to use as a tourniquet. I didn’t even have a bandage.

Worse: We were seeing high-velocity gunshot wounds that I’ve seen for 20 years in the Army. I know how to take care of them. I know how to fix them. But there wasn’t a single thing I could do.

We had to get people off the field, so we started gathering up as many as we could. We didn’t know if we were going to get shot at again, so we were trying to hide behind things as we ran. Our main objective was just to get people to a place of safety.

A lot of it is a blur. But a few patients stick out in my mind.

A father and son. The father had been shot through the abdomen, exited out through his back. He was in severe pain and couldn’t walk.

A young girl shot in the arm. Her parents carrying her.

A group of people doing CPR on a young lady. She had a gunshot wound to the head or neck. She was obviously dead. But they were still doing chest compressions in the middle of the field. I had to say to them: “She’s dead. You can’t save her. You need to get off the field.” But they wouldn’t stop. We picked her up and took her out while they continued to do CPR.

Later, I realized I knew that woman. She was part of a group of friends that we would see at the festival. I hadn’t recognized her. I also didn’t know that my friend Marco was there. A month or 2 later, we figured out that he was one of the people doing CPR. And I was the guy who came up and said his friend was dead.

Some people were so badly injured we couldn’t lift them. We started tearing apart the fencing used to separate the crowd and slid sections of the barricades under the wounded to carry them. We also carried off a bunch of people who were dead.

We were moving patients to a covered bar area where we thought they would be safer. What we didn’t know was there was an ambulance rally point at the very far end of the field. Unfortunately, we had no idea it was there.

I saw a lot of other first responders out there, people from the fire department, corpsmen from the Navy, medics. I ran into an anesthesia provider and a series of nurses.

When we got everybody off the field, we started moving them into vehicles. People were bringing their trucks up. One guy even stole a truck so he could drive people to the ED. There wasn’t a lot of triage. We were just stacking whoever we could into the backs of these pickups.

I tried to help a nurse taking care of a lady who had been shot in the neck. She was sitting sort of half upright with the patient lying in her arms. When I reached to help her, she said: “You can’t move her.”

“We need to get her to the hospital,” I replied.

“This is the only position that this lady has an airway,” she said. “You’re going to have to move both of us together. If I move at all, she loses her airway.”

So, a group of us managed to slide something underneath and lift them into the back of a truck.

Loading the wounded went on for a while. And then, just like that, everybody was gone.

I walked back out onto this field which not too long ago held 30,000 people. It was as if aliens had just suddenly beamed everyone out.

There was stuff on the ground everywhere – blankets, clothing, single boots, wallets, purses. I walked past a food stand with food still cooking on the grill. There was a beer tap still running. It was the weirdest feeling I’d ever had in my life.

After that, things got a little crazy again. There had been a report of a second shooter, and no one knew if it was real or not. The police started herding a group of us across the street to the Tropicana. We were still trying to take cover as we walked there. We went past a big lion statue in front of one of the casinos. I have a picture from two years earlier of me sitting on the back of that lion. I remember thinking: Now I’m hunkered down behind the same lion hiding from a shooter. Times change.

They brought about 50 of us into a food court, which was closed. They wouldn’t tell us what was going on. And they wouldn’t let us leave. This went on for hours. Meanwhile, I had dropped my cell phone on the field, so my wife couldn’t get hold of me, and later she told me she assumed I’d been shot. I was just hoping that she was safe.

People were huddled together, crying, holding each other. Most were wearing Western concert–going stuff, which for a lot of them wasn’t very much clothing. The hotel eventually brought some blankets.

I was covered in blood. My shirt, shorts, and sandals were soaked. It was running down my legs. I couldn’t find anything to eat or drink. At one point, I sat down at a slot machine, put a hundred dollars in, and started playing slots. I didn’t know what else to do. It didn’t take me very long to lose it all.

Finally, I started looking for a way to get out. I checked all the exits, but there were security and police there. Then I ran into a guy who said he had found a fire exit. When we opened the fire door, there was a big security guard there, and he said: “You can’t leave.”

We said: “Try to stop us. We’re out of here.”

Another thing I’ll always remember – after I broke out of the Tropicana, I was low crawling through the bushes along the Strip toward my hotel. I got a block away and stood up to cross the street. I pushed the crosswalk button and waited. There were no cars, no people. I’ve just broken all the rules, violated police orders, and now I’m standing there waiting for a blinking light to allow me to cross the street!

I made it back to my hotel room around 3:30 or 4:00 in the morning. My wife was hysterical because I hadn’t been answering my cell phone. I came in, and she gave me a big hug, and I got in the shower. Our plane was leaving in a few hours, so we laid down, but didn’t sleep.

As we were getting ready to leave, my wife’s phone rang, and it was my number. A guy at the same hotel had found my phone on the field and called the “in case of emergency” number. So, I got my phone back.

It wasn’t easy to deal with the aftermath. It really affected everybody’s life. To this day, I’m particular about where we sit at concerts. My wife isn’t comfortable if she can’t see an exit. I now have a med bag in my car with tourniquets, pressure dressings, airway masks for CPR.

I’ll never forget that feeling of absolute frustration. That lady without an airway – I could’ve put a trach in her very quickly and made a difference. Were they able to keep her airway? Did she live?

The father and son – did the father make it? I have no idea what happened to any of them. Later, I went through and looked at the pictures of all the people who had died, but I couldn’t recognize anybody.

The hardest part was being there with my wife. I’ve been in places where people are shooting at you, in vehicles that are getting bombed. I’ve always believed that when it’s your time, it’s your time. If I get shot, well, okay, that happens. But if she got shot or my friends ... that would be really tough.

A year later, I gave a talk about it at a conference. I thought I had worked through everything. But all of those feelings, all of that helplessness, that anger, everything came roaring back to the surface again. They asked me how I deal with it, and I said: “Well ... poorly.” I’m the guy who sticks it in a box in the back of his brain, tucks it in and buries it with a bunch of other boxes, and hopes it never comes out again. But every once in a while, it does.

There were all kinds of people out on that field, some with medical training, some without, all determined to help, trying to get those injured people where they needed to be. In retrospect, it does make you feel good. Somebody was shooting at us, but people were still willing to stand up and risk their lives to help others.

We still talk with our friends about what happened that night. Over the years, it’s become less and less. But there’s still a text sent out every year on that day: “Today is the anniversary. Glad we’re all alive. Thanks for being our friends.”

Dr. Sebesta is a bariatric surgeon with MultiCare Health System in Tacoma, Wash.

A version of this article first appeared on Medscape.com.

Sunday night. Las Vegas. Jason Aldean had just started playing.

My wife and I were at the 2017 Route 91 Harvest Festival with three other couples; two of them were our close friends. We were sitting in the VIP section, a tented area right next to the stage. We started hearing what I was convinced were fireworks.

I’ve been in the Army for 20 some years. I’ve been deployed and shot at multiple times. But these shots were far away. And you don’t expect people to be shooting at you at a concert.

I was on the edge of the VIP area, so I could see around the corner of the tent. I looked up at the Mandalay Bay and saw the muzzle flash in the hotel window. That’s when I knew.

I screamed: “Somebody’s shooting at us! Everybody get down!”

It took a while for people to realize what was going on. When the first couple volleys sprayed into the crowd, nobody understood. But once enough people had been hit and dropped, everyone knew, and it was just mass exodus.

People screamed and ran everywhere. Some of them tried to jump over the front barrier so they could get underneath the stage. Others were trying to pick up loved ones who’d been shot.

The next 15 minutes are a little foggy. I was helping my wife and the people around us to get down. Funny things come back to you afterward. One of my friends was carrying a 16-ounce beer in his hand. Somebody’s shooting at him and he’s walking around with his beer like he’s afraid to put it down. It was so surreal.

We got everybody underneath the tent, and then we just sat there. There would be shooting and then a pause. You’d think it was over. And then there would be more shooting and another pause. It felt like it never was going to stop.

After a short period of time, somebody came in with an official badge, maybe FBI, who knows. They said: “Okay, everybody up. We’ve got to get you out of here.” So, we all got up and headed across the stage. The gate they were taking us to was in full view of the shooter, so it wasn’t very safe.

As I got up, I looked out at the field. Bodies were scattered everywhere. I’m a trauma surgeon by trade. I couldn’t just leave.

I told my two best friends to take my wife with them. My wife lost her mind at that point. She didn’t want me to run out on the field. But I had to. I saw the injured and they needed help. Another buddy and I jumped over the fence and started taking care of people.

The feeling of being out on the field was one of complete frustration. I was in sandals, shorts, and a t-shirt. We had no stretchers, no medical supplies, no nothing. I didn’t have a belt to use as a tourniquet. I didn’t even have a bandage.

Worse: We were seeing high-velocity gunshot wounds that I’ve seen for 20 years in the Army. I know how to take care of them. I know how to fix them. But there wasn’t a single thing I could do.

We had to get people off the field, so we started gathering up as many as we could. We didn’t know if we were going to get shot at again, so we were trying to hide behind things as we ran. Our main objective was just to get people to a place of safety.

A lot of it is a blur. But a few patients stick out in my mind.

A father and son. The father had been shot through the abdomen, exited out through his back. He was in severe pain and couldn’t walk.

A young girl shot in the arm. Her parents carrying her.

A group of people doing CPR on a young lady. She had a gunshot wound to the head or neck. She was obviously dead. But they were still doing chest compressions in the middle of the field. I had to say to them: “She’s dead. You can’t save her. You need to get off the field.” But they wouldn’t stop. We picked her up and took her out while they continued to do CPR.

Later, I realized I knew that woman. She was part of a group of friends that we would see at the festival. I hadn’t recognized her. I also didn’t know that my friend Marco was there. A month or 2 later, we figured out that he was one of the people doing CPR. And I was the guy who came up and said his friend was dead.

Some people were so badly injured we couldn’t lift them. We started tearing apart the fencing used to separate the crowd and slid sections of the barricades under the wounded to carry them. We also carried off a bunch of people who were dead.

We were moving patients to a covered bar area where we thought they would be safer. What we didn’t know was there was an ambulance rally point at the very far end of the field. Unfortunately, we had no idea it was there.

I saw a lot of other first responders out there, people from the fire department, corpsmen from the Navy, medics. I ran into an anesthesia provider and a series of nurses.

When we got everybody off the field, we started moving them into vehicles. People were bringing their trucks up. One guy even stole a truck so he could drive people to the ED. There wasn’t a lot of triage. We were just stacking whoever we could into the backs of these pickups.

I tried to help a nurse taking care of a lady who had been shot in the neck. She was sitting sort of half upright with the patient lying in her arms. When I reached to help her, she said: “You can’t move her.”

“We need to get her to the hospital,” I replied.

“This is the only position that this lady has an airway,” she said. “You’re going to have to move both of us together. If I move at all, she loses her airway.”

So, a group of us managed to slide something underneath and lift them into the back of a truck.

Loading the wounded went on for a while. And then, just like that, everybody was gone.

I walked back out onto this field which not too long ago held 30,000 people. It was as if aliens had just suddenly beamed everyone out.

There was stuff on the ground everywhere – blankets, clothing, single boots, wallets, purses. I walked past a food stand with food still cooking on the grill. There was a beer tap still running. It was the weirdest feeling I’d ever had in my life.

After that, things got a little crazy again. There had been a report of a second shooter, and no one knew if it was real or not. The police started herding a group of us across the street to the Tropicana. We were still trying to take cover as we walked there. We went past a big lion statue in front of one of the casinos. I have a picture from two years earlier of me sitting on the back of that lion. I remember thinking: Now I’m hunkered down behind the same lion hiding from a shooter. Times change.

They brought about 50 of us into a food court, which was closed. They wouldn’t tell us what was going on. And they wouldn’t let us leave. This went on for hours. Meanwhile, I had dropped my cell phone on the field, so my wife couldn’t get hold of me, and later she told me she assumed I’d been shot. I was just hoping that she was safe.

People were huddled together, crying, holding each other. Most were wearing Western concert–going stuff, which for a lot of them wasn’t very much clothing. The hotel eventually brought some blankets.

I was covered in blood. My shirt, shorts, and sandals were soaked. It was running down my legs. I couldn’t find anything to eat or drink. At one point, I sat down at a slot machine, put a hundred dollars in, and started playing slots. I didn’t know what else to do. It didn’t take me very long to lose it all.

Finally, I started looking for a way to get out. I checked all the exits, but there were security and police there. Then I ran into a guy who said he had found a fire exit. When we opened the fire door, there was a big security guard there, and he said: “You can’t leave.”

We said: “Try to stop us. We’re out of here.”

Another thing I’ll always remember – after I broke out of the Tropicana, I was low crawling through the bushes along the Strip toward my hotel. I got a block away and stood up to cross the street. I pushed the crosswalk button and waited. There were no cars, no people. I’ve just broken all the rules, violated police orders, and now I’m standing there waiting for a blinking light to allow me to cross the street!

I made it back to my hotel room around 3:30 or 4:00 in the morning. My wife was hysterical because I hadn’t been answering my cell phone. I came in, and she gave me a big hug, and I got in the shower. Our plane was leaving in a few hours, so we laid down, but didn’t sleep.

As we were getting ready to leave, my wife’s phone rang, and it was my number. A guy at the same hotel had found my phone on the field and called the “in case of emergency” number. So, I got my phone back.

It wasn’t easy to deal with the aftermath. It really affected everybody’s life. To this day, I’m particular about where we sit at concerts. My wife isn’t comfortable if she can’t see an exit. I now have a med bag in my car with tourniquets, pressure dressings, airway masks for CPR.

I’ll never forget that feeling of absolute frustration. That lady without an airway – I could’ve put a trach in her very quickly and made a difference. Were they able to keep her airway? Did she live?

The father and son – did the father make it? I have no idea what happened to any of them. Later, I went through and looked at the pictures of all the people who had died, but I couldn’t recognize anybody.

The hardest part was being there with my wife. I’ve been in places where people are shooting at you, in vehicles that are getting bombed. I’ve always believed that when it’s your time, it’s your time. If I get shot, well, okay, that happens. But if she got shot or my friends ... that would be really tough.

A year later, I gave a talk about it at a conference. I thought I had worked through everything. But all of those feelings, all of that helplessness, that anger, everything came roaring back to the surface again. They asked me how I deal with it, and I said: “Well ... poorly.” I’m the guy who sticks it in a box in the back of his brain, tucks it in and buries it with a bunch of other boxes, and hopes it never comes out again. But every once in a while, it does.

There were all kinds of people out on that field, some with medical training, some without, all determined to help, trying to get those injured people where they needed to be. In retrospect, it does make you feel good. Somebody was shooting at us, but people were still willing to stand up and risk their lives to help others.

We still talk with our friends about what happened that night. Over the years, it’s become less and less. But there’s still a text sent out every year on that day: “Today is the anniversary. Glad we’re all alive. Thanks for being our friends.”

Dr. Sebesta is a bariatric surgeon with MultiCare Health System in Tacoma, Wash.

A version of this article first appeared on Medscape.com.

Sunday night. Las Vegas. Jason Aldean had just started playing.

My wife and I were at the 2017 Route 91 Harvest Festival with three other couples; two of them were our close friends. We were sitting in the VIP section, a tented area right next to the stage. We started hearing what I was convinced were fireworks.

I’ve been in the Army for 20 some years. I’ve been deployed and shot at multiple times. But these shots were far away. And you don’t expect people to be shooting at you at a concert.

I was on the edge of the VIP area, so I could see around the corner of the tent. I looked up at the Mandalay Bay and saw the muzzle flash in the hotel window. That’s when I knew.

I screamed: “Somebody’s shooting at us! Everybody get down!”

It took a while for people to realize what was going on. When the first couple volleys sprayed into the crowd, nobody understood. But once enough people had been hit and dropped, everyone knew, and it was just mass exodus.

People screamed and ran everywhere. Some of them tried to jump over the front barrier so they could get underneath the stage. Others were trying to pick up loved ones who’d been shot.

The next 15 minutes are a little foggy. I was helping my wife and the people around us to get down. Funny things come back to you afterward. One of my friends was carrying a 16-ounce beer in his hand. Somebody’s shooting at him and he’s walking around with his beer like he’s afraid to put it down. It was so surreal.

We got everybody underneath the tent, and then we just sat there. There would be shooting and then a pause. You’d think it was over. And then there would be more shooting and another pause. It felt like it never was going to stop.

After a short period of time, somebody came in with an official badge, maybe FBI, who knows. They said: “Okay, everybody up. We’ve got to get you out of here.” So, we all got up and headed across the stage. The gate they were taking us to was in full view of the shooter, so it wasn’t very safe.

As I got up, I looked out at the field. Bodies were scattered everywhere. I’m a trauma surgeon by trade. I couldn’t just leave.

I told my two best friends to take my wife with them. My wife lost her mind at that point. She didn’t want me to run out on the field. But I had to. I saw the injured and they needed help. Another buddy and I jumped over the fence and started taking care of people.

The feeling of being out on the field was one of complete frustration. I was in sandals, shorts, and a t-shirt. We had no stretchers, no medical supplies, no nothing. I didn’t have a belt to use as a tourniquet. I didn’t even have a bandage.

Worse: We were seeing high-velocity gunshot wounds that I’ve seen for 20 years in the Army. I know how to take care of them. I know how to fix them. But there wasn’t a single thing I could do.

We had to get people off the field, so we started gathering up as many as we could. We didn’t know if we were going to get shot at again, so we were trying to hide behind things as we ran. Our main objective was just to get people to a place of safety.

A lot of it is a blur. But a few patients stick out in my mind.

A father and son. The father had been shot through the abdomen, exited out through his back. He was in severe pain and couldn’t walk.

A young girl shot in the arm. Her parents carrying her.

A group of people doing CPR on a young lady. She had a gunshot wound to the head or neck. She was obviously dead. But they were still doing chest compressions in the middle of the field. I had to say to them: “She’s dead. You can’t save her. You need to get off the field.” But they wouldn’t stop. We picked her up and took her out while they continued to do CPR.

Later, I realized I knew that woman. She was part of a group of friends that we would see at the festival. I hadn’t recognized her. I also didn’t know that my friend Marco was there. A month or 2 later, we figured out that he was one of the people doing CPR. And I was the guy who came up and said his friend was dead.

Some people were so badly injured we couldn’t lift them. We started tearing apart the fencing used to separate the crowd and slid sections of the barricades under the wounded to carry them. We also carried off a bunch of people who were dead.

We were moving patients to a covered bar area where we thought they would be safer. What we didn’t know was there was an ambulance rally point at the very far end of the field. Unfortunately, we had no idea it was there.

I saw a lot of other first responders out there, people from the fire department, corpsmen from the Navy, medics. I ran into an anesthesia provider and a series of nurses.

When we got everybody off the field, we started moving them into vehicles. People were bringing their trucks up. One guy even stole a truck so he could drive people to the ED. There wasn’t a lot of triage. We were just stacking whoever we could into the backs of these pickups.

I tried to help a nurse taking care of a lady who had been shot in the neck. She was sitting sort of half upright with the patient lying in her arms. When I reached to help her, she said: “You can’t move her.”

“We need to get her to the hospital,” I replied.

“This is the only position that this lady has an airway,” she said. “You’re going to have to move both of us together. If I move at all, she loses her airway.”

So, a group of us managed to slide something underneath and lift them into the back of a truck.

Loading the wounded went on for a while. And then, just like that, everybody was gone.

I walked back out onto this field which not too long ago held 30,000 people. It was as if aliens had just suddenly beamed everyone out.

There was stuff on the ground everywhere – blankets, clothing, single boots, wallets, purses. I walked past a food stand with food still cooking on the grill. There was a beer tap still running. It was the weirdest feeling I’d ever had in my life.

After that, things got a little crazy again. There had been a report of a second shooter, and no one knew if it was real or not. The police started herding a group of us across the street to the Tropicana. We were still trying to take cover as we walked there. We went past a big lion statue in front of one of the casinos. I have a picture from two years earlier of me sitting on the back of that lion. I remember thinking: Now I’m hunkered down behind the same lion hiding from a shooter. Times change.

They brought about 50 of us into a food court, which was closed. They wouldn’t tell us what was going on. And they wouldn’t let us leave. This went on for hours. Meanwhile, I had dropped my cell phone on the field, so my wife couldn’t get hold of me, and later she told me she assumed I’d been shot. I was just hoping that she was safe.

People were huddled together, crying, holding each other. Most were wearing Western concert–going stuff, which for a lot of them wasn’t very much clothing. The hotel eventually brought some blankets.

I was covered in blood. My shirt, shorts, and sandals were soaked. It was running down my legs. I couldn’t find anything to eat or drink. At one point, I sat down at a slot machine, put a hundred dollars in, and started playing slots. I didn’t know what else to do. It didn’t take me very long to lose it all.

Finally, I started looking for a way to get out. I checked all the exits, but there were security and police there. Then I ran into a guy who said he had found a fire exit. When we opened the fire door, there was a big security guard there, and he said: “You can’t leave.”

We said: “Try to stop us. We’re out of here.”

Another thing I’ll always remember – after I broke out of the Tropicana, I was low crawling through the bushes along the Strip toward my hotel. I got a block away and stood up to cross the street. I pushed the crosswalk button and waited. There were no cars, no people. I’ve just broken all the rules, violated police orders, and now I’m standing there waiting for a blinking light to allow me to cross the street!

I made it back to my hotel room around 3:30 or 4:00 in the morning. My wife was hysterical because I hadn’t been answering my cell phone. I came in, and she gave me a big hug, and I got in the shower. Our plane was leaving in a few hours, so we laid down, but didn’t sleep.

As we were getting ready to leave, my wife’s phone rang, and it was my number. A guy at the same hotel had found my phone on the field and called the “in case of emergency” number. So, I got my phone back.

It wasn’t easy to deal with the aftermath. It really affected everybody’s life. To this day, I’m particular about where we sit at concerts. My wife isn’t comfortable if she can’t see an exit. I now have a med bag in my car with tourniquets, pressure dressings, airway masks for CPR.

I’ll never forget that feeling of absolute frustration. That lady without an airway – I could’ve put a trach in her very quickly and made a difference. Were they able to keep her airway? Did she live?

The father and son – did the father make it? I have no idea what happened to any of them. Later, I went through and looked at the pictures of all the people who had died, but I couldn’t recognize anybody.

The hardest part was being there with my wife. I’ve been in places where people are shooting at you, in vehicles that are getting bombed. I’ve always believed that when it’s your time, it’s your time. If I get shot, well, okay, that happens. But if she got shot or my friends ... that would be really tough.

A year later, I gave a talk about it at a conference. I thought I had worked through everything. But all of those feelings, all of that helplessness, that anger, everything came roaring back to the surface again. They asked me how I deal with it, and I said: “Well ... poorly.” I’m the guy who sticks it in a box in the back of his brain, tucks it in and buries it with a bunch of other boxes, and hopes it never comes out again. But every once in a while, it does.

There were all kinds of people out on that field, some with medical training, some without, all determined to help, trying to get those injured people where they needed to be. In retrospect, it does make you feel good. Somebody was shooting at us, but people were still willing to stand up and risk their lives to help others.

We still talk with our friends about what happened that night. Over the years, it’s become less and less. But there’s still a text sent out every year on that day: “Today is the anniversary. Glad we’re all alive. Thanks for being our friends.”

Dr. Sebesta is a bariatric surgeon with MultiCare Health System in Tacoma, Wash.

A version of this article first appeared on Medscape.com.

A pair of genetically modified pig kidneys filtered blood and produced urine for 7 days after being transplanted into a brain-dead patient – marking another important step toward opening up a new supply of much-needed organs for those with end-stage kidney disease.

A team of researchers in Alabama removed a brain-dead person’s kidneys and transplanted two kidneys that had been taken from a genetically modified pig. The researchers monitored the patient’s response to the organs and tracked the kidneys’ function over a 7-day period. The findings were published in JAMA Surgery.

During the first 24 hours after transplantation, the pig kidneys made more than 37 liters of urine. “It was really a remarkable thing to see,” lead investigator Jayme Locke, MD, professor of surgery and the Arnold G. Diethelm Endowed Chair in Transplantation Surgery, University of Alabama at Birmingham, said in a press release.

The recipient was given standard maintenance immunosuppression - tacrolimus, mycophenolate mofetil, and prednisone. The target tacrolimus level (8-10 ng/dL) was reached by postoperative day 2 and was maintained through study completion.

At the end of the study, the serum creatinine level was 0.9 mg/dL, and creatinine clearance was 200 mL/min. Creatinine levels are an indicator of kidney function and demonstrate the organ’s ability to filter waste from blood, according to Roger Lord, PhD, senior lecturer (medical sciences) in the School of Behavioural and Health Sciences, Australian Catholic University, who was not involved in the research.

This is the first time that it has been demonstrated that a standard immunosuppression regimen may be sufficient to support xenotransplantation with pig kidneys and in which creatinine clearance was achieved.

The finding comes less than 2 years after the same team published results from a similar experiment. In that transplant, the investigators didn’t observe significant creatinine excretion into the urine.

In the team’s previous attempts, kidney function was delayed because the brain-dead recipients had deteriorated physiologically. This time, the subject was stable, and the team was able to observe urine production within 4 minutes of restoration of blood flow to the transplanted pig organs.

“This new work firmly establishes that the xenografts not only make urine but provide life-sustaining kidney function by clearing serum creatinine,” Locke said in an interview. “This is the first time in history this has been shown.”

The investigators are hoping animal-sourced organs could become an alternative for human transplantations, potentially solving the serious shortage of human organs available for patients on transplant waiting lists.

Organ transplantation can treat patients with advanced kidney disease and kidney failure, but there are not enough human organs available to meet the need. More than 92,000 people in the United States are waiting for a kidney, according to the American Kidney Fund.

Organ rejection is a risk with xenotransplants – animal-to-human organ transplants. Investigators in this study used kidneys from pigs with 10 gene modifications. The modifications were intended to decrease the likelihood of the organs being rejected by a human host.

The kidneys were still viable at the end of the 7-day period. In addition, there was no microscopic blood clot formation, another indicator of normal kidney function, according to Dr. Lord, who provided comments to the UK Science Media Centre.

The long-term outcomes of animal-to-human organ transplantation remain unclear. Dr. Lord describes the operation as a “first step” to demonstrate that genetically modified, transplanted pig kidneys can function normally so as to remove creatinine over a 7-day period.

Dr. Locke and colleagues said: “Future research in living human recipients is necessary to determine long-term xenograft kidney function and whether xenografts could serve as a bridge or destination therapy for end-stage kidney disease.

“Because our study represents a single case, generalizability of the findings is limited. This study showcases xenotransplant as a viable potential solution to an organ shortage crisis responsible for thousands of preventable deaths annually,” they concluded.

A version of this article first appeared on Medscape.com .

A pair of genetically modified pig kidneys filtered blood and produced urine for 7 days after being transplanted into a brain-dead patient – marking another important step toward opening up a new supply of much-needed organs for those with end-stage kidney disease.

A team of researchers in Alabama removed a brain-dead person’s kidneys and transplanted two kidneys that had been taken from a genetically modified pig. The researchers monitored the patient’s response to the organs and tracked the kidneys’ function over a 7-day period. The findings were published in JAMA Surgery.

During the first 24 hours after transplantation, the pig kidneys made more than 37 liters of urine. “It was really a remarkable thing to see,” lead investigator Jayme Locke, MD, professor of surgery and the Arnold G. Diethelm Endowed Chair in Transplantation Surgery, University of Alabama at Birmingham, said in a press release.

The recipient was given standard maintenance immunosuppression - tacrolimus, mycophenolate mofetil, and prednisone. The target tacrolimus level (8-10 ng/dL) was reached by postoperative day 2 and was maintained through study completion.

At the end of the study, the serum creatinine level was 0.9 mg/dL, and creatinine clearance was 200 mL/min. Creatinine levels are an indicator of kidney function and demonstrate the organ’s ability to filter waste from blood, according to Roger Lord, PhD, senior lecturer (medical sciences) in the School of Behavioural and Health Sciences, Australian Catholic University, who was not involved in the research.

This is the first time that it has been demonstrated that a standard immunosuppression regimen may be sufficient to support xenotransplantation with pig kidneys and in which creatinine clearance was achieved.

The finding comes less than 2 years after the same team published results from a similar experiment. In that transplant, the investigators didn’t observe significant creatinine excretion into the urine.

In the team’s previous attempts, kidney function was delayed because the brain-dead recipients had deteriorated physiologically. This time, the subject was stable, and the team was able to observe urine production within 4 minutes of restoration of blood flow to the transplanted pig organs.

“This new work firmly establishes that the xenografts not only make urine but provide life-sustaining kidney function by clearing serum creatinine,” Locke said in an interview. “This is the first time in history this has been shown.”

The investigators are hoping animal-sourced organs could become an alternative for human transplantations, potentially solving the serious shortage of human organs available for patients on transplant waiting lists.

Organ transplantation can treat patients with advanced kidney disease and kidney failure, but there are not enough human organs available to meet the need. More than 92,000 people in the United States are waiting for a kidney, according to the American Kidney Fund.

Organ rejection is a risk with xenotransplants – animal-to-human organ transplants. Investigators in this study used kidneys from pigs with 10 gene modifications. The modifications were intended to decrease the likelihood of the organs being rejected by a human host.

The kidneys were still viable at the end of the 7-day period. In addition, there was no microscopic blood clot formation, another indicator of normal kidney function, according to Dr. Lord, who provided comments to the UK Science Media Centre.

The long-term outcomes of animal-to-human organ transplantation remain unclear. Dr. Lord describes the operation as a “first step” to demonstrate that genetically modified, transplanted pig kidneys can function normally so as to remove creatinine over a 7-day period.

Dr. Locke and colleagues said: “Future research in living human recipients is necessary to determine long-term xenograft kidney function and whether xenografts could serve as a bridge or destination therapy for end-stage kidney disease.

“Because our study represents a single case, generalizability of the findings is limited. This study showcases xenotransplant as a viable potential solution to an organ shortage crisis responsible for thousands of preventable deaths annually,” they concluded.

A version of this article first appeared on Medscape.com .

A pair of genetically modified pig kidneys filtered blood and produced urine for 7 days after being transplanted into a brain-dead patient – marking another important step toward opening up a new supply of much-needed organs for those with end-stage kidney disease.

A team of researchers in Alabama removed a brain-dead person’s kidneys and transplanted two kidneys that had been taken from a genetically modified pig. The researchers monitored the patient’s response to the organs and tracked the kidneys’ function over a 7-day period. The findings were published in JAMA Surgery.

During the first 24 hours after transplantation, the pig kidneys made more than 37 liters of urine. “It was really a remarkable thing to see,” lead investigator Jayme Locke, MD, professor of surgery and the Arnold G. Diethelm Endowed Chair in Transplantation Surgery, University of Alabama at Birmingham, said in a press release.

The recipient was given standard maintenance immunosuppression - tacrolimus, mycophenolate mofetil, and prednisone. The target tacrolimus level (8-10 ng/dL) was reached by postoperative day 2 and was maintained through study completion.

At the end of the study, the serum creatinine level was 0.9 mg/dL, and creatinine clearance was 200 mL/min. Creatinine levels are an indicator of kidney function and demonstrate the organ’s ability to filter waste from blood, according to Roger Lord, PhD, senior lecturer (medical sciences) in the School of Behavioural and Health Sciences, Australian Catholic University, who was not involved in the research.

This is the first time that it has been demonstrated that a standard immunosuppression regimen may be sufficient to support xenotransplantation with pig kidneys and in which creatinine clearance was achieved.

The finding comes less than 2 years after the same team published results from a similar experiment. In that transplant, the investigators didn’t observe significant creatinine excretion into the urine.

In the team’s previous attempts, kidney function was delayed because the brain-dead recipients had deteriorated physiologically. This time, the subject was stable, and the team was able to observe urine production within 4 minutes of restoration of blood flow to the transplanted pig organs.

“This new work firmly establishes that the xenografts not only make urine but provide life-sustaining kidney function by clearing serum creatinine,” Locke said in an interview. “This is the first time in history this has been shown.”

The investigators are hoping animal-sourced organs could become an alternative for human transplantations, potentially solving the serious shortage of human organs available for patients on transplant waiting lists.

Organ transplantation can treat patients with advanced kidney disease and kidney failure, but there are not enough human organs available to meet the need. More than 92,000 people in the United States are waiting for a kidney, according to the American Kidney Fund.

Organ rejection is a risk with xenotransplants – animal-to-human organ transplants. Investigators in this study used kidneys from pigs with 10 gene modifications. The modifications were intended to decrease the likelihood of the organs being rejected by a human host.

The kidneys were still viable at the end of the 7-day period. In addition, there was no microscopic blood clot formation, another indicator of normal kidney function, according to Dr. Lord, who provided comments to the UK Science Media Centre.

The long-term outcomes of animal-to-human organ transplantation remain unclear. Dr. Lord describes the operation as a “first step” to demonstrate that genetically modified, transplanted pig kidneys can function normally so as to remove creatinine over a 7-day period.

Dr. Locke and colleagues said: “Future research in living human recipients is necessary to determine long-term xenograft kidney function and whether xenografts could serve as a bridge or destination therapy for end-stage kidney disease.

“Because our study represents a single case, generalizability of the findings is limited. This study showcases xenotransplant as a viable potential solution to an organ shortage crisis responsible for thousands of preventable deaths annually,” they concluded.

A version of this article first appeared on Medscape.com .

Nearly 90,000 patients in the United States are waiting for a lifesaving kidney transplant, yet only about 25,000 kidney transplants were performed last year. Thousands die each year while they wait. Others are not suitable transplant candidates.

Half a million people are on dialysis, the only transplant alternative for those with kidney failure. This greatly impacts their work, relationships, and quality of life.

Researchers from The Kidney Project hope to solve this public health crisis with a futuristic approach: an implantable bioartificial kidney. That hope is slowly approaching reality. Early prototypes have been tested successfully in preclinical research and clinical trials could lie ahead.

This news organization spoke with two researchers who came up with the idea: nephrologist William Dr. Fissell, MD, of Vanderbilt University in Nashville, Tenn., and Shuvo Dr. Roy, PhD, a biomedical engineer at the University of California, San Francisco. This interview has been edited for length and clarity.
 

Question: Could you summarize the clinical problem with chronic kidney disease?

Dr. Fissell: Dialysis treatment, although lifesaving, is incomplete. Healthy kidneys do a variety of things that dialysis cannot provide. Transplant is absolutely the best remedy, but donor organs are vanishingly scarce. Our goal has been to develop a mass-produced, universal donor kidney to render the issue of scarcity – scarcity of time, scarcity of resources, scarcity of money, scarcity of donor organs – irrelevant.

Do you envision your implantable, bioartificial kidney as a bridge to transplantation? Or can it be even more, like a bionic organ, as good as a natural organ and thus better than a transplant?

Dr. Roy: We see it initially as a bridge to transplantation or as a better option than dialysis for those who will never get a transplant. We’re not trying to create the “Six Million Dollar Man.” The goal is to keep patients off dialysis – to deliver some, but probably not all, of the benefits of a kidney transplant in a mass-produced device that anybody can receive.

Dr. Fissell: The technology is aimed at people in stage 5 renal disease, the final stage, when kidneys are failing, and dialysis is the only option to maintain life. We want to make dialysis a thing of the past, put dialysis machines in museums like the iron lung, which was so vital to keeping people alive several decades ago but is mostly obsolete today.

How did you two come up with this idea? How did you get started working together?

Dr. Roy: I had just begun my career as a research biomedical engineer when I met Dr. William Fissell, who was then contemplating a career in nephrology. He opened my eyes to the problems faced by patients affected by kidney failure. Through our discussions, we quickly realized that while we could improve dialysis machines, patients needed and deserved something better – a treatment that improves their health while also allowing them to keep a job, travel readily, and consume food and drink without restrictions. Basically, something that works more like a kidney transplant.

How does the artificial kidney differ from dialysis?

Dr. Fissell: Dialysis is an intermittent stop-and-start treatment. The artificial kidney is continuous, around-the-clock treatment. There are a couple of advantages to that. The first is that you can maintain your body’s fluid balance. In dialysis, you get rid of 2-3 days’ worth of fluid in a couple of hours, and that’s very stressful to the heart and maybe to the brain as well. Second advantage is that patients will be able to eat a normal diet. Some waste products that are byproducts of our nutritional intake are slow to leave the body. So in dialysis, we restrict the diet severely and add medicines to soak up extra phosphorus. With a continuous treatment, you can balance excretion and intake.

The other aspect is that dialysis requires an immense amount of disposables. Hundreds of liters of water per patient per treatment, hundreds of thousands of dialysis cartridges and IV bags every year. The artificial kidney doesn’t need a water supply, disposable sorbent, or cartridges.
 

How does the artificial kidney work?

Dr. Fissell: Just like a healthy kidney. We have a unit that filters the blood so that red blood cells, white blood cells, platelets, antibodies, albumin – all the good stuff that your body worked hard to synthesize – stays in the blood, but a watery soup of toxins and waste is separated out. In a second unit, called the bioreactor, kidney cells concentrate those wastes and toxins into urine.

Dr. Roy: We used a technology called silicon micro-machining to invent an entirely new membrane that mimics a healthy kidney’s filters. It filters the blood just using the patient’s heart as a pump. No electric motors, no batteries, no wires. This lets us have something that’s completely implanted.

We also developed a cell culture of kidney cells that function in an artificial kidney. Normally, cells in a dish don’t fully adopt the features of a cell in the body. We looked at the literature around 3-D printing of organs. We learned that, in addition to fluid flow, stiff scaffolds, like cell culture dishes, trigger specific signals that keep the cells from functioning. We overcame that by looking at the physical microenvironment of the cells –  not the hormones and proteins, but instead the fundamentals of the laboratory environment. For example, most organs are soft, yet plastic lab dishes are hard. By using tools that replicated the softness and fluid flow of a healthy kidney, remarkably, these cells functioned better than on a plastic dish.
 

Would patients need immunosuppressive or anticoagulation medication?

Dr. Fissell: They wouldn’t need either. The structure and chemistry of the device prevents blood from clotting. And the membranes in the device are a physical barrier between the host immune system and the donor cells, so the body won’t reject the device.

What is the state of the technology now?

Dr. Fissell: We have shown the function of the filters and the function of the cells, both separately and together, in preclinical in vivo testing. What we now need to do is construct clinical-grade devices and complete sterility and biocompatibility testing to initiate a human trial. That’s going to take between $12 million and $15 million in device manufacturing.

So it’s more a matter of money than time until the first clinical trials?

Dr. Roy: Yes, exactly. We don’t like to say that a clinical trial will start by such-and-such year. From the very start of the project, we have been resource limited.

A version of this article first appeared on Medscape.com.

Nearly 90,000 patients in the United States are waiting for a lifesaving kidney transplant, yet only about 25,000 kidney transplants were performed last year. Thousands die each year while they wait. Others are not suitable transplant candidates.

Half a million people are on dialysis, the only transplant alternative for those with kidney failure. This greatly impacts their work, relationships, and quality of life.

Researchers from The Kidney Project hope to solve this public health crisis with a futuristic approach: an implantable bioartificial kidney. That hope is slowly approaching reality. Early prototypes have been tested successfully in preclinical research and clinical trials could lie ahead.

This news organization spoke with two researchers who came up with the idea: nephrologist William Dr. Fissell, MD, of Vanderbilt University in Nashville, Tenn., and Shuvo Dr. Roy, PhD, a biomedical engineer at the University of California, San Francisco. This interview has been edited for length and clarity.
 

Question: Could you summarize the clinical problem with chronic kidney disease?

Dr. Fissell: Dialysis treatment, although lifesaving, is incomplete. Healthy kidneys do a variety of things that dialysis cannot provide. Transplant is absolutely the best remedy, but donor organs are vanishingly scarce. Our goal has been to develop a mass-produced, universal donor kidney to render the issue of scarcity – scarcity of time, scarcity of resources, scarcity of money, scarcity of donor organs – irrelevant.

Do you envision your implantable, bioartificial kidney as a bridge to transplantation? Or can it be even more, like a bionic organ, as good as a natural organ and thus better than a transplant?

Dr. Roy: We see it initially as a bridge to transplantation or as a better option than dialysis for those who will never get a transplant. We’re not trying to create the “Six Million Dollar Man.” The goal is to keep patients off dialysis – to deliver some, but probably not all, of the benefits of a kidney transplant in a mass-produced device that anybody can receive.

Dr. Fissell: The technology is aimed at people in stage 5 renal disease, the final stage, when kidneys are failing, and dialysis is the only option to maintain life. We want to make dialysis a thing of the past, put dialysis machines in museums like the iron lung, which was so vital to keeping people alive several decades ago but is mostly obsolete today.

How did you two come up with this idea? How did you get started working together?

Dr. Roy: I had just begun my career as a research biomedical engineer when I met Dr. William Fissell, who was then contemplating a career in nephrology. He opened my eyes to the problems faced by patients affected by kidney failure. Through our discussions, we quickly realized that while we could improve dialysis machines, patients needed and deserved something better – a treatment that improves their health while also allowing them to keep a job, travel readily, and consume food and drink without restrictions. Basically, something that works more like a kidney transplant.

How does the artificial kidney differ from dialysis?

Dr. Fissell: Dialysis is an intermittent stop-and-start treatment. The artificial kidney is continuous, around-the-clock treatment. There are a couple of advantages to that. The first is that you can maintain your body’s fluid balance. In dialysis, you get rid of 2-3 days’ worth of fluid in a couple of hours, and that’s very stressful to the heart and maybe to the brain as well. Second advantage is that patients will be able to eat a normal diet. Some waste products that are byproducts of our nutritional intake are slow to leave the body. So in dialysis, we restrict the diet severely and add medicines to soak up extra phosphorus. With a continuous treatment, you can balance excretion and intake.

The other aspect is that dialysis requires an immense amount of disposables. Hundreds of liters of water per patient per treatment, hundreds of thousands of dialysis cartridges and IV bags every year. The artificial kidney doesn’t need a water supply, disposable sorbent, or cartridges.
 

How does the artificial kidney work?

Dr. Fissell: Just like a healthy kidney. We have a unit that filters the blood so that red blood cells, white blood cells, platelets, antibodies, albumin – all the good stuff that your body worked hard to synthesize – stays in the blood, but a watery soup of toxins and waste is separated out. In a second unit, called the bioreactor, kidney cells concentrate those wastes and toxins into urine.

Dr. Roy: We used a technology called silicon micro-machining to invent an entirely new membrane that mimics a healthy kidney’s filters. It filters the blood just using the patient’s heart as a pump. No electric motors, no batteries, no wires. This lets us have something that’s completely implanted.

We also developed a cell culture of kidney cells that function in an artificial kidney. Normally, cells in a dish don’t fully adopt the features of a cell in the body. We looked at the literature around 3-D printing of organs. We learned that, in addition to fluid flow, stiff scaffolds, like cell culture dishes, trigger specific signals that keep the cells from functioning. We overcame that by looking at the physical microenvironment of the cells –  not the hormones and proteins, but instead the fundamentals of the laboratory environment. For example, most organs are soft, yet plastic lab dishes are hard. By using tools that replicated the softness and fluid flow of a healthy kidney, remarkably, these cells functioned better than on a plastic dish.
 

Would patients need immunosuppressive or anticoagulation medication?

Dr. Fissell: They wouldn’t need either. The structure and chemistry of the device prevents blood from clotting. And the membranes in the device are a physical barrier between the host immune system and the donor cells, so the body won’t reject the device.

What is the state of the technology now?

Dr. Fissell: We have shown the function of the filters and the function of the cells, both separately and together, in preclinical in vivo testing. What we now need to do is construct clinical-grade devices and complete sterility and biocompatibility testing to initiate a human trial. That’s going to take between $12 million and $15 million in device manufacturing.

So it’s more a matter of money than time until the first clinical trials?

Dr. Roy: Yes, exactly. We don’t like to say that a clinical trial will start by such-and-such year. From the very start of the project, we have been resource limited.

A version of this article first appeared on Medscape.com.

Nearly 90,000 patients in the United States are waiting for a lifesaving kidney transplant, yet only about 25,000 kidney transplants were performed last year. Thousands die each year while they wait. Others are not suitable transplant candidates.

Half a million people are on dialysis, the only transplant alternative for those with kidney failure. This greatly impacts their work, relationships, and quality of life.

Researchers from The Kidney Project hope to solve this public health crisis with a futuristic approach: an implantable bioartificial kidney. That hope is slowly approaching reality. Early prototypes have been tested successfully in preclinical research and clinical trials could lie ahead.

This news organization spoke with two researchers who came up with the idea: nephrologist William Dr. Fissell, MD, of Vanderbilt University in Nashville, Tenn., and Shuvo Dr. Roy, PhD, a biomedical engineer at the University of California, San Francisco. This interview has been edited for length and clarity.
 

Question: Could you summarize the clinical problem with chronic kidney disease?

Dr. Fissell: Dialysis treatment, although lifesaving, is incomplete. Healthy kidneys do a variety of things that dialysis cannot provide. Transplant is absolutely the best remedy, but donor organs are vanishingly scarce. Our goal has been to develop a mass-produced, universal donor kidney to render the issue of scarcity – scarcity of time, scarcity of resources, scarcity of money, scarcity of donor organs – irrelevant.

Do you envision your implantable, bioartificial kidney as a bridge to transplantation? Or can it be even more, like a bionic organ, as good as a natural organ and thus better than a transplant?

Dr. Roy: We see it initially as a bridge to transplantation or as a better option than dialysis for those who will never get a transplant. We’re not trying to create the “Six Million Dollar Man.” The goal is to keep patients off dialysis – to deliver some, but probably not all, of the benefits of a kidney transplant in a mass-produced device that anybody can receive.

Dr. Fissell: The technology is aimed at people in stage 5 renal disease, the final stage, when kidneys are failing, and dialysis is the only option to maintain life. We want to make dialysis a thing of the past, put dialysis machines in museums like the iron lung, which was so vital to keeping people alive several decades ago but is mostly obsolete today.

How did you two come up with this idea? How did you get started working together?

Dr. Roy: I had just begun my career as a research biomedical engineer when I met Dr. William Fissell, who was then contemplating a career in nephrology. He opened my eyes to the problems faced by patients affected by kidney failure. Through our discussions, we quickly realized that while we could improve dialysis machines, patients needed and deserved something better – a treatment that improves their health while also allowing them to keep a job, travel readily, and consume food and drink without restrictions. Basically, something that works more like a kidney transplant.

How does the artificial kidney differ from dialysis?

Dr. Fissell: Dialysis is an intermittent stop-and-start treatment. The artificial kidney is continuous, around-the-clock treatment. There are a couple of advantages to that. The first is that you can maintain your body’s fluid balance. In dialysis, you get rid of 2-3 days’ worth of fluid in a couple of hours, and that’s very stressful to the heart and maybe to the brain as well. Second advantage is that patients will be able to eat a normal diet. Some waste products that are byproducts of our nutritional intake are slow to leave the body. So in dialysis, we restrict the diet severely and add medicines to soak up extra phosphorus. With a continuous treatment, you can balance excretion and intake.

The other aspect is that dialysis requires an immense amount of disposables. Hundreds of liters of water per patient per treatment, hundreds of thousands of dialysis cartridges and IV bags every year. The artificial kidney doesn’t need a water supply, disposable sorbent, or cartridges.
 

How does the artificial kidney work?

Dr. Fissell: Just like a healthy kidney. We have a unit that filters the blood so that red blood cells, white blood cells, platelets, antibodies, albumin – all the good stuff that your body worked hard to synthesize – stays in the blood, but a watery soup of toxins and waste is separated out. In a second unit, called the bioreactor, kidney cells concentrate those wastes and toxins into urine.

Dr. Roy: We used a technology called silicon micro-machining to invent an entirely new membrane that mimics a healthy kidney’s filters. It filters the blood just using the patient’s heart as a pump. No electric motors, no batteries, no wires. This lets us have something that’s completely implanted.

We also developed a cell culture of kidney cells that function in an artificial kidney. Normally, cells in a dish don’t fully adopt the features of a cell in the body. We looked at the literature around 3-D printing of organs. We learned that, in addition to fluid flow, stiff scaffolds, like cell culture dishes, trigger specific signals that keep the cells from functioning. We overcame that by looking at the physical microenvironment of the cells –  not the hormones and proteins, but instead the fundamentals of the laboratory environment. For example, most organs are soft, yet plastic lab dishes are hard. By using tools that replicated the softness and fluid flow of a healthy kidney, remarkably, these cells functioned better than on a plastic dish.
 

Would patients need immunosuppressive or anticoagulation medication?

Dr. Fissell: They wouldn’t need either. The structure and chemistry of the device prevents blood from clotting. And the membranes in the device are a physical barrier between the host immune system and the donor cells, so the body won’t reject the device.

What is the state of the technology now?

Dr. Fissell: We have shown the function of the filters and the function of the cells, both separately and together, in preclinical in vivo testing. What we now need to do is construct clinical-grade devices and complete sterility and biocompatibility testing to initiate a human trial. That’s going to take between $12 million and $15 million in device manufacturing.

So it’s more a matter of money than time until the first clinical trials?

Dr. Roy: Yes, exactly. We don’t like to say that a clinical trial will start by such-and-such year. From the very start of the project, we have been resource limited.

A version of this article first appeared on Medscape.com.

For carefully selected patients with colorectal cancer (CRC), a liver transplant may offer long-term survival and potentially even cure unresectable liver metastases.

Findings from a Norwegian review of 61 patients who had liver transplants for unresectable colorectal liver metastases found half of patients were still alive at 5 years, and about one in five appeared to be cured at 10 years.

“It seems likely that there is a small group of patients with unresectable colorectal liver metastases who should be considered for transplant, and long-term survival and possibly cure are achievable in these patients with appropriate selection,” Ryan Ellis, MD, and Michael D’Angelica, MD, wrote in a commentary published alongside the study in JAMA Surgery.

The core question, however, is how to identify patients who will benefit the most from a liver transplant, said Dr. Ellis and Dr. D’Angelica, both surgical oncologists in the Hepatopancreatobiliary Service at Memorial Sloan Kettering Cancer Center, New York. Looking closely at who did well in this analysis can offer clues to appropriate patient selection, the editorialists said.

Three decades ago, the oncology community had largely abandoned liver transplant in this population after studies showed overall 5-year survival of less than 20%. Some patients, however, did better, which prompted the Norwegian investigators to attempt to refine patient selection.

In the current prospective nonrandomized study, 61 patients had liver transplants for unresectable metastases at Oslo University Hospital from 2006 to 2020.

The researchers reported a median overall survival of 60.3 months, with about half of patients (50.4%) alive at 5 years.

Most patients (78.3%) experienced a relapse after liver transplant, with a median time to relapse of 9 months and with most occurring within 2 years of transplant. Median overall survival from time of relapse was 37.1 months, with 5-year survival at nearly 35% in this group and with one patient still alive 156 months after relapse.

The remaining 21.7% of patients (n = 13) did not experience a relapse post-transplant at their last follow-up.

Given the variety of responses to liver transplant, how can experts differentiate patients who will benefit most from those who won’t?

The researchers looked at several factors, including Oslo score and Fong Clinical Risk Score. The Oslo score assesses overall survival among liver transplant patients, while the Fong score predicts recurrence risk for patients with CRC liver metastasis following resection. These scores assign one point for each adverse prognostic factor.

Among the 10 patients who had an Oslo Score of 0, median overall survival was 151.6 months, and the 5-year and 10-year survival rates reached nearly 89%. Among the 27 patients with an Oslo Score of 1, median overall survival was 60.3 months, and 5-year overall survival was 54.7%. No patients with an Oslo score of 4 lived for 5 years.

As for FCRS, median overall survival was 164.9 months among those with a score of 1, 90.5 months among those with a score of 2, 59.9 months for those with a score of 3, 32.8 months for those with a score of 4, and 25.3 months for those with the highest score of 5 (P < .001). Overall, these patients had 5-year overall survival of 100%, 63.9%, 49.4%, 33.3%, and 0%, respectively.

In addition to Oslo and Fong scores, metabolic tumor volume on PET scan (PET-MTV) was also a good prognostic factor for survival. Among the 40 patients with MTV values less than 70 cm³, median 5-year overall survival was nearly 67%, while those with values above 70 cm³ had a median 5-year overall survival of 23.3%.

Additional harbingers of low 5-year survival, in addition to higher Oslo and Fong scores and PET-MTV above 70 cm³, included a tumor size greater than 5.5 cm, progressive disease while receiving chemotherapy, primary tumors in the ascending colon, tumor burden scores of 9 or higher, and nine or more liver lesions.

Overall, the current analysis can help oncologists identify patients who may benefit from a liver transplant.

The findings indicate that “patients with liver-only metastases and favorable pretransplant prognostic scoring [have] long-term survival comparable with conventional indications for liver transplant, thus providing a potential curative treatment option in patients otherwise offered only palliative care,” said investigators led by Svein Dueland, MD, PhD, a member of the Transplant Oncology Research Group at Oslo University Hospital.

Perhaps “the most compelling argument in favor of liver transplant lies in the likely curative potential evidenced by the 13 disease-free patients,” Dr. Ellis and Dr. D’Angelica wrote.

But even some patients who had early recurrences did well following transplant. The investigators noted that early recurrences in this population aren’t as dire as in other settings because they generally manifest as slow growing lung metastases that can be caught early and resected with curative intent.

A major hurdle to broader use of liver transplants in this population is the scarcity of donor grafts. To manage demand, the investigators suggested “extended-criteria donor grafts” – grafts that don’t meet ideal criteria – and the use of the RAPID technique for liver transplant, which opens the door to using one graft for two patients and using living donors with low risk to the donor.

Another challenge will be identifying patients with unresectable colorectal liver metastases who may experience long-term survival following transplant and possibly a cure. “We all will need to keep a sharp eye out for these patients – they might be hard to find!” Dr. Ellis and Dr. D’Angelica wrote.

The study was supported by Oslo University Hospital, the Norwegian Cancer Society, and South-Eastern Norway Regional Health Authority. The investigators and editorialists report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

For carefully selected patients with colorectal cancer (CRC), a liver transplant may offer long-term survival and potentially even cure unresectable liver metastases.

Findings from a Norwegian review of 61 patients who had liver transplants for unresectable colorectal liver metastases found half of patients were still alive at 5 years, and about one in five appeared to be cured at 10 years.

“It seems likely that there is a small group of patients with unresectable colorectal liver metastases who should be considered for transplant, and long-term survival and possibly cure are achievable in these patients with appropriate selection,” Ryan Ellis, MD, and Michael D’Angelica, MD, wrote in a commentary published alongside the study in JAMA Surgery.

The core question, however, is how to identify patients who will benefit the most from a liver transplant, said Dr. Ellis and Dr. D’Angelica, both surgical oncologists in the Hepatopancreatobiliary Service at Memorial Sloan Kettering Cancer Center, New York. Looking closely at who did well in this analysis can offer clues to appropriate patient selection, the editorialists said.

Three decades ago, the oncology community had largely abandoned liver transplant in this population after studies showed overall 5-year survival of less than 20%. Some patients, however, did better, which prompted the Norwegian investigators to attempt to refine patient selection.

In the current prospective nonrandomized study, 61 patients had liver transplants for unresectable metastases at Oslo University Hospital from 2006 to 2020.

The researchers reported a median overall survival of 60.3 months, with about half of patients (50.4%) alive at 5 years.

Most patients (78.3%) experienced a relapse after liver transplant, with a median time to relapse of 9 months and with most occurring within 2 years of transplant. Median overall survival from time of relapse was 37.1 months, with 5-year survival at nearly 35% in this group and with one patient still alive 156 months after relapse.

The remaining 21.7% of patients (n = 13) did not experience a relapse post-transplant at their last follow-up.

Given the variety of responses to liver transplant, how can experts differentiate patients who will benefit most from those who won’t?

The researchers looked at several factors, including Oslo score and Fong Clinical Risk Score. The Oslo score assesses overall survival among liver transplant patients, while the Fong score predicts recurrence risk for patients with CRC liver metastasis following resection. These scores assign one point for each adverse prognostic factor.

Among the 10 patients who had an Oslo Score of 0, median overall survival was 151.6 months, and the 5-year and 10-year survival rates reached nearly 89%. Among the 27 patients with an Oslo Score of 1, median overall survival was 60.3 months, and 5-year overall survival was 54.7%. No patients with an Oslo score of 4 lived for 5 years.

As for FCRS, median overall survival was 164.9 months among those with a score of 1, 90.5 months among those with a score of 2, 59.9 months for those with a score of 3, 32.8 months for those with a score of 4, and 25.3 months for those with the highest score of 5 (P < .001). Overall, these patients had 5-year overall survival of 100%, 63.9%, 49.4%, 33.3%, and 0%, respectively.

In addition to Oslo and Fong scores, metabolic tumor volume on PET scan (PET-MTV) was also a good prognostic factor for survival. Among the 40 patients with MTV values less than 70 cm³, median 5-year overall survival was nearly 67%, while those with values above 70 cm³ had a median 5-year overall survival of 23.3%.

Additional harbingers of low 5-year survival, in addition to higher Oslo and Fong scores and PET-MTV above 70 cm³, included a tumor size greater than 5.5 cm, progressive disease while receiving chemotherapy, primary tumors in the ascending colon, tumor burden scores of 9 or higher, and nine or more liver lesions.

Overall, the current analysis can help oncologists identify patients who may benefit from a liver transplant.

The findings indicate that “patients with liver-only metastases and favorable pretransplant prognostic scoring [have] long-term survival comparable with conventional indications for liver transplant, thus providing a potential curative treatment option in patients otherwise offered only palliative care,” said investigators led by Svein Dueland, MD, PhD, a member of the Transplant Oncology Research Group at Oslo University Hospital.

Perhaps “the most compelling argument in favor of liver transplant lies in the likely curative potential evidenced by the 13 disease-free patients,” Dr. Ellis and Dr. D’Angelica wrote.

But even some patients who had early recurrences did well following transplant. The investigators noted that early recurrences in this population aren’t as dire as in other settings because they generally manifest as slow growing lung metastases that can be caught early and resected with curative intent.

A major hurdle to broader use of liver transplants in this population is the scarcity of donor grafts. To manage demand, the investigators suggested “extended-criteria donor grafts” – grafts that don’t meet ideal criteria – and the use of the RAPID technique for liver transplant, which opens the door to using one graft for two patients and using living donors with low risk to the donor.

Another challenge will be identifying patients with unresectable colorectal liver metastases who may experience long-term survival following transplant and possibly a cure. “We all will need to keep a sharp eye out for these patients – they might be hard to find!” Dr. Ellis and Dr. D’Angelica wrote.

The study was supported by Oslo University Hospital, the Norwegian Cancer Society, and South-Eastern Norway Regional Health Authority. The investigators and editorialists report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

For carefully selected patients with colorectal cancer (CRC), a liver transplant may offer long-term survival and potentially even cure unresectable liver metastases.

Findings from a Norwegian review of 61 patients who had liver transplants for unresectable colorectal liver metastases found half of patients were still alive at 5 years, and about one in five appeared to be cured at 10 years.

“It seems likely that there is a small group of patients with unresectable colorectal liver metastases who should be considered for transplant, and long-term survival and possibly cure are achievable in these patients with appropriate selection,” Ryan Ellis, MD, and Michael D’Angelica, MD, wrote in a commentary published alongside the study in JAMA Surgery.

The core question, however, is how to identify patients who will benefit the most from a liver transplant, said Dr. Ellis and Dr. D’Angelica, both surgical oncologists in the Hepatopancreatobiliary Service at Memorial Sloan Kettering Cancer Center, New York. Looking closely at who did well in this analysis can offer clues to appropriate patient selection, the editorialists said.

Three decades ago, the oncology community had largely abandoned liver transplant in this population after studies showed overall 5-year survival of less than 20%. Some patients, however, did better, which prompted the Norwegian investigators to attempt to refine patient selection.

In the current prospective nonrandomized study, 61 patients had liver transplants for unresectable metastases at Oslo University Hospital from 2006 to 2020.

The researchers reported a median overall survival of 60.3 months, with about half of patients (50.4%) alive at 5 years.

Most patients (78.3%) experienced a relapse after liver transplant, with a median time to relapse of 9 months and with most occurring within 2 years of transplant. Median overall survival from time of relapse was 37.1 months, with 5-year survival at nearly 35% in this group and with one patient still alive 156 months after relapse.

The remaining 21.7% of patients (n = 13) did not experience a relapse post-transplant at their last follow-up.

Given the variety of responses to liver transplant, how can experts differentiate patients who will benefit most from those who won’t?

The researchers looked at several factors, including Oslo score and Fong Clinical Risk Score. The Oslo score assesses overall survival among liver transplant patients, while the Fong score predicts recurrence risk for patients with CRC liver metastasis following resection. These scores assign one point for each adverse prognostic factor.

Among the 10 patients who had an Oslo Score of 0, median overall survival was 151.6 months, and the 5-year and 10-year survival rates reached nearly 89%. Among the 27 patients with an Oslo Score of 1, median overall survival was 60.3 months, and 5-year overall survival was 54.7%. No patients with an Oslo score of 4 lived for 5 years.

As for FCRS, median overall survival was 164.9 months among those with a score of 1, 90.5 months among those with a score of 2, 59.9 months for those with a score of 3, 32.8 months for those with a score of 4, and 25.3 months for those with the highest score of 5 (P < .001). Overall, these patients had 5-year overall survival of 100%, 63.9%, 49.4%, 33.3%, and 0%, respectively.

In addition to Oslo and Fong scores, metabolic tumor volume on PET scan (PET-MTV) was also a good prognostic factor for survival. Among the 40 patients with MTV values less than 70 cm³, median 5-year overall survival was nearly 67%, while those with values above 70 cm³ had a median 5-year overall survival of 23.3%.

Additional harbingers of low 5-year survival, in addition to higher Oslo and Fong scores and PET-MTV above 70 cm³, included a tumor size greater than 5.5 cm, progressive disease while receiving chemotherapy, primary tumors in the ascending colon, tumor burden scores of 9 or higher, and nine or more liver lesions.

Overall, the current analysis can help oncologists identify patients who may benefit from a liver transplant.

The findings indicate that “patients with liver-only metastases and favorable pretransplant prognostic scoring [have] long-term survival comparable with conventional indications for liver transplant, thus providing a potential curative treatment option in patients otherwise offered only palliative care,” said investigators led by Svein Dueland, MD, PhD, a member of the Transplant Oncology Research Group at Oslo University Hospital.

Perhaps “the most compelling argument in favor of liver transplant lies in the likely curative potential evidenced by the 13 disease-free patients,” Dr. Ellis and Dr. D’Angelica wrote.

But even some patients who had early recurrences did well following transplant. The investigators noted that early recurrences in this population aren’t as dire as in other settings because they generally manifest as slow growing lung metastases that can be caught early and resected with curative intent.

A major hurdle to broader use of liver transplants in this population is the scarcity of donor grafts. To manage demand, the investigators suggested “extended-criteria donor grafts” – grafts that don’t meet ideal criteria – and the use of the RAPID technique for liver transplant, which opens the door to using one graft for two patients and using living donors with low risk to the donor.

Another challenge will be identifying patients with unresectable colorectal liver metastases who may experience long-term survival following transplant and possibly a cure. “We all will need to keep a sharp eye out for these patients – they might be hard to find!” Dr. Ellis and Dr. D’Angelica wrote.

The study was supported by Oslo University Hospital, the Norwegian Cancer Society, and South-Eastern Norway Regional Health Authority. The investigators and editorialists report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

For patients with uterine prolapse, a traditional technique showed superiority, while vaginal estrogen cream failed to improve outcomes for vaginal apical prolapse repair in two new studies published in JAMA.

“Approximately one in five women will undergo surgery for prolapse and/or urinary incontinence by the age of 80, which is more likely than the risk of developing breast cancer,” said David D. Rahn, MD, corresponding author of the study on perioperative vaginal estrogen, in an interview.

University of Texas Southwestern Medical Center

“About 13% of women will specifically undergo surgery to repair pelvic organ prolapse,” said Dr. Rahn, of the department of obstetrics and gynecology, University of Texas Southwestern Medical Center, Dallas. Reoperation for recurrent prolapse is not uncommon.

In their study, Dr. Rahn and colleagues examined whether the addition of perioperative vaginal estrogen cream in postmenopausal women with prolapse planning surgical correction could both strengthen the repair and lessen the likelihood of recurrence. The researchers randomized 206 postmenopausal women who were seeking surgical repair for bothersome anterior and apical vaginal prolapse to 1 gram of conjugated estrogen cream or a placebo for nightly vaginal insertion for 2 weeks, then twice weekly for at least 5 weeks of preoperative use. The treatment continued twice weekly for 12 months following surgery.

The primary outcome was the time to a failed prolapse repair by 12 months after surgery. Failure was defined by at least one of three criteria, “anatomical/objective prolapse of anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment,” the researchers wrote. The mean age of the patients was 65 years, and 90% and 92% of patients in the treatment and placebo groups, respectively, were White; 10% and 5%, respectively, were Black. Other baseline characteristics were similar between the groups.

After 12 months, the surgical failure incidence was not significantly different between the vaginal estrogen and placebo groups (19% vs. 9%, respectively; adjusted hazard ratio, 1.97).

Overall, anatomic recurrence was the most common outcome associated with surgical failure.

However, vaginal atrophy scores for most bothersome symptom was significantly better at 12 months in the vaginal estrogen group, compared with the placebo group, in a subset of 109 patients who reported vaginal atrophy that was at least “moderately bothersome,” the researchers said.

The findings were limited by several factors including the use of a nonvalidated instrument to assess secondary outcomes, the potentially short time period to the primary outcome, and the inclusion of the apex descending below one third total vaginal length as a criterion for surgical failure (which could be considered conservative), the researchers noted.
 

Unexpected results

“This work followed logically from a pilot study that similarly randomized postmenopausal women with prolapse planning surgical repair to vaginal estrogen cream versus placebo,” Dr. Rahn said. “In that smaller study, full thickness vaginal wall biopsies were collected at the time of surgery. Those participants who received the estrogen had a thicker vaginal epithelium, thicker underlying muscularis, and appeared to have a more robust concentration of strong connective tissue (i.e., type I collagen) with less of the proteases that break down connective tissue.”

This suggested that preoperative estrogen might optimize the vaginal tissue at the time of the repair. Dr. Rahn said. However, “despite evidence that the application of vaginal estrogen cream decreased the symptoms and signs of atrophic vaginal tissues, this did not lessen the likelihood of pelvic organ prolapse recurrence 12 months after surgical repair.”

The current study “would argue against routine prescription of vaginal estrogen to optimize vaginal tissue for prolapse repair, a practice that is recommended by some experts and commonly prescribed anecdotally,” said Dr. Rahn. “However, in those patients with prolapse and bothersome atrophy-related complaints such as vaginal dryness and pain with intercourse, vaginal estrogen may still be appropriate,” and vaginal estrogen also could be useful for postoperatively for patients prone to recurrent urinary tract infections. 

Additional research from the study is underway, said Dr. Rahn. “All participants have now been followed to 3 years after surgery, and those clinical results are now being analyzed. In addition, full-thickness vaginal wall biopsies were collected at the time of all 186 surgeries; these are being analyzed and may yield important information regarding how biomarkers for connective tissue health could point to increased (or decreased) risk for prolapse recurrence.”
 

Manchester technique surpasses sacrospinous hysteropexy

In the second JAMA study, sacrospinous hysteropexy for uterine-sparing surgical management of uterine prolapse was less effective than the older Manchester procedure, based on data from nearly 400 individuals.

“Until now, the optimal uterus-sparing procedure for the treatment of uterine descent remained uncertain,” lead author Rosa Enklaar, MD, of Radboud (the Netherlands) University Medical Center, said in an interview.

courtesy Radboud University Medical Center

“Globally, there has been a lack of scientific evidence comparing the efficacy of these two techniques, and this study aims to bridge that gap,” she said.

In their study, Dr. Enklaar and colleagues randomized 215 women to sacrospinous hysteropexy and 215 to the Manchester procedure. The mean age of the participants was 61.7 years.

The Manchester procedure involves “extraperitoneal plication of the uterosacral ligaments at the posterior side of the uterus and amputation of the cervix,” and “the cardinal ligaments are plicated on the anterior side of the cervix, “ the researchers wrote.

The primary outcome was a composite outcome of surgical success at 2 years after surgery, defined as the absence of three elements: absence of vaginal prolapse beyond the hymen, absence of bothersome bulge symptoms, and absence of retreatment of current prolapse.

Overall, 87.3% of patients in the Manchester group and 77.0% in the sacrospinous hysteropexy group met the primary outcome. At the end of the 2-year follow-up period, perioperative and patient-reported outcomes were not significantly different between the groups.

Dr. Enklaar said she was surprised by the findings. “At the start of this study, we hypothesized that there would be no difference between the two techniques,” as both have been used for a long period of time.

However, “based on the composite outcome of success at 2-year follow-up after the primary uterus-sparing surgery for uterine descent in patients with pelvic organ prolapse, these findings indicate that the sacrospinous hysteropexy is inferior to the Manchester procedure,” she said.

The study findings were limited by several factors including the lack of blinding and the applicability of the results only to women without uterine prolapse past the hymen, as well as the exclusion of patients with higher-stage prolapse, the researchers said. However, the results suggest that sacrospinous hysteropexy is inferior to the Manchester technique for uterine-sparing pelvic organ prolapse surgery.

As for additional research, few studies of prolapse surgery with long-term follow-up data are available, Dr. Enklaar said. “It is important that this current study will be continued to see the results after a longer follow-up period. Personalized health care is increasingly important, and we need to provide adequate information when counselling patients. With studies such as this one, we hope to improve the choices regarding surgical treatment of uterine descent.”
 

Studies challenge current prolapse protocols

The study by Dr. Rahn and colleagues contradicts the common clinical practice of preoperative vaginal estrogen to reduce recurrence of prolapse, wrote Charles W. Nager, MD, of the University of California San Diego Health, La Jolla, in an accompanying editorial that addressed both studies.

University of California San Diego Health

The results suggest that use of perioperative intravaginal estrogen had no impact on outcomes, “despite the surgeon assessment of less atrophy and better vaginal apex tissue in the estrogen group,” he noted. Although vaginal estrogen has other benefits in terms of patient symptoms and effects on the vaginal epithelium, “surgeons should not prescribe vaginal estrogen with the expectation that it will improve surgical success.”

The study by Dr. Enklaar and colleagues reflects the growing interest in uterine-conserving procedures, Dr. Nager wrote. The modified Manchester procedure conforms to professional society guidelines, and the composite outcome conforms to current standards for the treatment of pelvic organ prolapse.

Although suspension of the vaginal apex was quite successful, the researchers interpreted their noninferiority findings with caution, said Dr. Nager. However, they suggested that the modified Manchester procedure as performed in their study “has a role in modern prolapse surgical repair for women with uterine descent that does not protrude beyond the hymen.”

The vaginal estrogen study was supported by the National Institute on Aging, a Bridge Award from the American Board of Obstetrics & Gynecology and the American Association of Obstetricians and Gynecologists Foundation. Dr. Rahn disclosed grants from the National Institute on Aging, the American Board of Obstetrics & Gynecology, and the AAOGF bridge award, as well as nonfinancial support from National Center for Advancing Translational Sciences and Pfizer during the study. The uterine prolapse study was supported by the Netherlands Organisation for Health Research and Development. The researchers had no financial conflicts to disclose. Dr. Nager had no financial conflicts to disclose.

For patients with uterine prolapse, a traditional technique showed superiority, while vaginal estrogen cream failed to improve outcomes for vaginal apical prolapse repair in two new studies published in JAMA.

“Approximately one in five women will undergo surgery for prolapse and/or urinary incontinence by the age of 80, which is more likely than the risk of developing breast cancer,” said David D. Rahn, MD, corresponding author of the study on perioperative vaginal estrogen, in an interview.

University of Texas Southwestern Medical Center

“About 13% of women will specifically undergo surgery to repair pelvic organ prolapse,” said Dr. Rahn, of the department of obstetrics and gynecology, University of Texas Southwestern Medical Center, Dallas. Reoperation for recurrent prolapse is not uncommon.

In their study, Dr. Rahn and colleagues examined whether the addition of perioperative vaginal estrogen cream in postmenopausal women with prolapse planning surgical correction could both strengthen the repair and lessen the likelihood of recurrence. The researchers randomized 206 postmenopausal women who were seeking surgical repair for bothersome anterior and apical vaginal prolapse to 1 gram of conjugated estrogen cream or a placebo for nightly vaginal insertion for 2 weeks, then twice weekly for at least 5 weeks of preoperative use. The treatment continued twice weekly for 12 months following surgery.

The primary outcome was the time to a failed prolapse repair by 12 months after surgery. Failure was defined by at least one of three criteria, “anatomical/objective prolapse of anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment,” the researchers wrote. The mean age of the patients was 65 years, and 90% and 92% of patients in the treatment and placebo groups, respectively, were White; 10% and 5%, respectively, were Black. Other baseline characteristics were similar between the groups.

After 12 months, the surgical failure incidence was not significantly different between the vaginal estrogen and placebo groups (19% vs. 9%, respectively; adjusted hazard ratio, 1.97).

Overall, anatomic recurrence was the most common outcome associated with surgical failure.

However, vaginal atrophy scores for most bothersome symptom was significantly better at 12 months in the vaginal estrogen group, compared with the placebo group, in a subset of 109 patients who reported vaginal atrophy that was at least “moderately bothersome,” the researchers said.

The findings were limited by several factors including the use of a nonvalidated instrument to assess secondary outcomes, the potentially short time period to the primary outcome, and the inclusion of the apex descending below one third total vaginal length as a criterion for surgical failure (which could be considered conservative), the researchers noted.
 

Unexpected results

“This work followed logically from a pilot study that similarly randomized postmenopausal women with prolapse planning surgical repair to vaginal estrogen cream versus placebo,” Dr. Rahn said. “In that smaller study, full thickness vaginal wall biopsies were collected at the time of surgery. Those participants who received the estrogen had a thicker vaginal epithelium, thicker underlying muscularis, and appeared to have a more robust concentration of strong connective tissue (i.e., type I collagen) with less of the proteases that break down connective tissue.”

This suggested that preoperative estrogen might optimize the vaginal tissue at the time of the repair. Dr. Rahn said. However, “despite evidence that the application of vaginal estrogen cream decreased the symptoms and signs of atrophic vaginal tissues, this did not lessen the likelihood of pelvic organ prolapse recurrence 12 months after surgical repair.”

The current study “would argue against routine prescription of vaginal estrogen to optimize vaginal tissue for prolapse repair, a practice that is recommended by some experts and commonly prescribed anecdotally,” said Dr. Rahn. “However, in those patients with prolapse and bothersome atrophy-related complaints such as vaginal dryness and pain with intercourse, vaginal estrogen may still be appropriate,” and vaginal estrogen also could be useful for postoperatively for patients prone to recurrent urinary tract infections. 

Additional research from the study is underway, said Dr. Rahn. “All participants have now been followed to 3 years after surgery, and those clinical results are now being analyzed. In addition, full-thickness vaginal wall biopsies were collected at the time of all 186 surgeries; these are being analyzed and may yield important information regarding how biomarkers for connective tissue health could point to increased (or decreased) risk for prolapse recurrence.”
 

Manchester technique surpasses sacrospinous hysteropexy

In the second JAMA study, sacrospinous hysteropexy for uterine-sparing surgical management of uterine prolapse was less effective than the older Manchester procedure, based on data from nearly 400 individuals.

“Until now, the optimal uterus-sparing procedure for the treatment of uterine descent remained uncertain,” lead author Rosa Enklaar, MD, of Radboud (the Netherlands) University Medical Center, said in an interview.

courtesy Radboud University Medical Center

“Globally, there has been a lack of scientific evidence comparing the efficacy of these two techniques, and this study aims to bridge that gap,” she said.

In their study, Dr. Enklaar and colleagues randomized 215 women to sacrospinous hysteropexy and 215 to the Manchester procedure. The mean age of the participants was 61.7 years.

The Manchester procedure involves “extraperitoneal plication of the uterosacral ligaments at the posterior side of the uterus and amputation of the cervix,” and “the cardinal ligaments are plicated on the anterior side of the cervix, “ the researchers wrote.

The primary outcome was a composite outcome of surgical success at 2 years after surgery, defined as the absence of three elements: absence of vaginal prolapse beyond the hymen, absence of bothersome bulge symptoms, and absence of retreatment of current prolapse.

Overall, 87.3% of patients in the Manchester group and 77.0% in the sacrospinous hysteropexy group met the primary outcome. At the end of the 2-year follow-up period, perioperative and patient-reported outcomes were not significantly different between the groups.

Dr. Enklaar said she was surprised by the findings. “At the start of this study, we hypothesized that there would be no difference between the two techniques,” as both have been used for a long period of time.

However, “based on the composite outcome of success at 2-year follow-up after the primary uterus-sparing surgery for uterine descent in patients with pelvic organ prolapse, these findings indicate that the sacrospinous hysteropexy is inferior to the Manchester procedure,” she said.

The study findings were limited by several factors including the lack of blinding and the applicability of the results only to women without uterine prolapse past the hymen, as well as the exclusion of patients with higher-stage prolapse, the researchers said. However, the results suggest that sacrospinous hysteropexy is inferior to the Manchester technique for uterine-sparing pelvic organ prolapse surgery.

As for additional research, few studies of prolapse surgery with long-term follow-up data are available, Dr. Enklaar said. “It is important that this current study will be continued to see the results after a longer follow-up period. Personalized health care is increasingly important, and we need to provide adequate information when counselling patients. With studies such as this one, we hope to improve the choices regarding surgical treatment of uterine descent.”
 

Studies challenge current prolapse protocols

The study by Dr. Rahn and colleagues contradicts the common clinical practice of preoperative vaginal estrogen to reduce recurrence of prolapse, wrote Charles W. Nager, MD, of the University of California San Diego Health, La Jolla, in an accompanying editorial that addressed both studies.

University of California San Diego Health

The results suggest that use of perioperative intravaginal estrogen had no impact on outcomes, “despite the surgeon assessment of less atrophy and better vaginal apex tissue in the estrogen group,” he noted. Although vaginal estrogen has other benefits in terms of patient symptoms and effects on the vaginal epithelium, “surgeons should not prescribe vaginal estrogen with the expectation that it will improve surgical success.”

The study by Dr. Enklaar and colleagues reflects the growing interest in uterine-conserving procedures, Dr. Nager wrote. The modified Manchester procedure conforms to professional society guidelines, and the composite outcome conforms to current standards for the treatment of pelvic organ prolapse.

Although suspension of the vaginal apex was quite successful, the researchers interpreted their noninferiority findings with caution, said Dr. Nager. However, they suggested that the modified Manchester procedure as performed in their study “has a role in modern prolapse surgical repair for women with uterine descent that does not protrude beyond the hymen.”

The vaginal estrogen study was supported by the National Institute on Aging, a Bridge Award from the American Board of Obstetrics & Gynecology and the American Association of Obstetricians and Gynecologists Foundation. Dr. Rahn disclosed grants from the National Institute on Aging, the American Board of Obstetrics & Gynecology, and the AAOGF bridge award, as well as nonfinancial support from National Center for Advancing Translational Sciences and Pfizer during the study. The uterine prolapse study was supported by the Netherlands Organisation for Health Research and Development. The researchers had no financial conflicts to disclose. Dr. Nager had no financial conflicts to disclose.

For patients with uterine prolapse, a traditional technique showed superiority, while vaginal estrogen cream failed to improve outcomes for vaginal apical prolapse repair in two new studies published in JAMA.

“Approximately one in five women will undergo surgery for prolapse and/or urinary incontinence by the age of 80, which is more likely than the risk of developing breast cancer,” said David D. Rahn, MD, corresponding author of the study on perioperative vaginal estrogen, in an interview.

University of Texas Southwestern Medical Center

“About 13% of women will specifically undergo surgery to repair pelvic organ prolapse,” said Dr. Rahn, of the department of obstetrics and gynecology, University of Texas Southwestern Medical Center, Dallas. Reoperation for recurrent prolapse is not uncommon.

In their study, Dr. Rahn and colleagues examined whether the addition of perioperative vaginal estrogen cream in postmenopausal women with prolapse planning surgical correction could both strengthen the repair and lessen the likelihood of recurrence. The researchers randomized 206 postmenopausal women who were seeking surgical repair for bothersome anterior and apical vaginal prolapse to 1 gram of conjugated estrogen cream or a placebo for nightly vaginal insertion for 2 weeks, then twice weekly for at least 5 weeks of preoperative use. The treatment continued twice weekly for 12 months following surgery.

The primary outcome was the time to a failed prolapse repair by 12 months after surgery. Failure was defined by at least one of three criteria, “anatomical/objective prolapse of anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment,” the researchers wrote. The mean age of the patients was 65 years, and 90% and 92% of patients in the treatment and placebo groups, respectively, were White; 10% and 5%, respectively, were Black. Other baseline characteristics were similar between the groups.

After 12 months, the surgical failure incidence was not significantly different between the vaginal estrogen and placebo groups (19% vs. 9%, respectively; adjusted hazard ratio, 1.97).

Overall, anatomic recurrence was the most common outcome associated with surgical failure.

However, vaginal atrophy scores for most bothersome symptom was significantly better at 12 months in the vaginal estrogen group, compared with the placebo group, in a subset of 109 patients who reported vaginal atrophy that was at least “moderately bothersome,” the researchers said.

The findings were limited by several factors including the use of a nonvalidated instrument to assess secondary outcomes, the potentially short time period to the primary outcome, and the inclusion of the apex descending below one third total vaginal length as a criterion for surgical failure (which could be considered conservative), the researchers noted.
 

Unexpected results

“This work followed logically from a pilot study that similarly randomized postmenopausal women with prolapse planning surgical repair to vaginal estrogen cream versus placebo,” Dr. Rahn said. “In that smaller study, full thickness vaginal wall biopsies were collected at the time of surgery. Those participants who received the estrogen had a thicker vaginal epithelium, thicker underlying muscularis, and appeared to have a more robust concentration of strong connective tissue (i.e., type I collagen) with less of the proteases that break down connective tissue.”

This suggested that preoperative estrogen might optimize the vaginal tissue at the time of the repair. Dr. Rahn said. However, “despite evidence that the application of vaginal estrogen cream decreased the symptoms and signs of atrophic vaginal tissues, this did not lessen the likelihood of pelvic organ prolapse recurrence 12 months after surgical repair.”

The current study “would argue against routine prescription of vaginal estrogen to optimize vaginal tissue for prolapse repair, a practice that is recommended by some experts and commonly prescribed anecdotally,” said Dr. Rahn. “However, in those patients with prolapse and bothersome atrophy-related complaints such as vaginal dryness and pain with intercourse, vaginal estrogen may still be appropriate,” and vaginal estrogen also could be useful for postoperatively for patients prone to recurrent urinary tract infections. 

Additional research from the study is underway, said Dr. Rahn. “All participants have now been followed to 3 years after surgery, and those clinical results are now being analyzed. In addition, full-thickness vaginal wall biopsies were collected at the time of all 186 surgeries; these are being analyzed and may yield important information regarding how biomarkers for connective tissue health could point to increased (or decreased) risk for prolapse recurrence.”
 

Manchester technique surpasses sacrospinous hysteropexy

In the second JAMA study, sacrospinous hysteropexy for uterine-sparing surgical management of uterine prolapse was less effective than the older Manchester procedure, based on data from nearly 400 individuals.

“Until now, the optimal uterus-sparing procedure for the treatment of uterine descent remained uncertain,” lead author Rosa Enklaar, MD, of Radboud (the Netherlands) University Medical Center, said in an interview.

courtesy Radboud University Medical Center

“Globally, there has been a lack of scientific evidence comparing the efficacy of these two techniques, and this study aims to bridge that gap,” she said.

In their study, Dr. Enklaar and colleagues randomized 215 women to sacrospinous hysteropexy and 215 to the Manchester procedure. The mean age of the participants was 61.7 years.

The Manchester procedure involves “extraperitoneal plication of the uterosacral ligaments at the posterior side of the uterus and amputation of the cervix,” and “the cardinal ligaments are plicated on the anterior side of the cervix, “ the researchers wrote.

The primary outcome was a composite outcome of surgical success at 2 years after surgery, defined as the absence of three elements: absence of vaginal prolapse beyond the hymen, absence of bothersome bulge symptoms, and absence of retreatment of current prolapse.

Overall, 87.3% of patients in the Manchester group and 77.0% in the sacrospinous hysteropexy group met the primary outcome. At the end of the 2-year follow-up period, perioperative and patient-reported outcomes were not significantly different between the groups.

Dr. Enklaar said she was surprised by the findings. “At the start of this study, we hypothesized that there would be no difference between the two techniques,” as both have been used for a long period of time.

However, “based on the composite outcome of success at 2-year follow-up after the primary uterus-sparing surgery for uterine descent in patients with pelvic organ prolapse, these findings indicate that the sacrospinous hysteropexy is inferior to the Manchester procedure,” she said.

The study findings were limited by several factors including the lack of blinding and the applicability of the results only to women without uterine prolapse past the hymen, as well as the exclusion of patients with higher-stage prolapse, the researchers said. However, the results suggest that sacrospinous hysteropexy is inferior to the Manchester technique for uterine-sparing pelvic organ prolapse surgery.

As for additional research, few studies of prolapse surgery with long-term follow-up data are available, Dr. Enklaar said. “It is important that this current study will be continued to see the results after a longer follow-up period. Personalized health care is increasingly important, and we need to provide adequate information when counselling patients. With studies such as this one, we hope to improve the choices regarding surgical treatment of uterine descent.”
 

Studies challenge current prolapse protocols

The study by Dr. Rahn and colleagues contradicts the common clinical practice of preoperative vaginal estrogen to reduce recurrence of prolapse, wrote Charles W. Nager, MD, of the University of California San Diego Health, La Jolla, in an accompanying editorial that addressed both studies.

University of California San Diego Health

The results suggest that use of perioperative intravaginal estrogen had no impact on outcomes, “despite the surgeon assessment of less atrophy and better vaginal apex tissue in the estrogen group,” he noted. Although vaginal estrogen has other benefits in terms of patient symptoms and effects on the vaginal epithelium, “surgeons should not prescribe vaginal estrogen with the expectation that it will improve surgical success.”

The study by Dr. Enklaar and colleagues reflects the growing interest in uterine-conserving procedures, Dr. Nager wrote. The modified Manchester procedure conforms to professional society guidelines, and the composite outcome conforms to current standards for the treatment of pelvic organ prolapse.

Although suspension of the vaginal apex was quite successful, the researchers interpreted their noninferiority findings with caution, said Dr. Nager. However, they suggested that the modified Manchester procedure as performed in their study “has a role in modern prolapse surgical repair for women with uterine descent that does not protrude beyond the hymen.”

The vaginal estrogen study was supported by the National Institute on Aging, a Bridge Award from the American Board of Obstetrics & Gynecology and the American Association of Obstetricians and Gynecologists Foundation. Dr. Rahn disclosed grants from the National Institute on Aging, the American Board of Obstetrics & Gynecology, and the AAOGF bridge award, as well as nonfinancial support from National Center for Advancing Translational Sciences and Pfizer during the study. The uterine prolapse study was supported by the Netherlands Organisation for Health Research and Development. The researchers had no financial conflicts to disclose. Dr. Nager had no financial conflicts to disclose.

Medical education has changed drastically over the years. As theories and practices continue to change, what was once standard 10 or 20 years ago has been replaced with newer ideologies, processes, or technology. It seems likely, then, that you may disagree with some of the things that you learned as medical school has evolved.

This news organization asked physicians what they learned in med school that they now contest. Many of their answers include newer philosophies and practice methods.
 

Treat appropriately for pain

Jacqui O’Kane, DO, a 2013 med school graduate, was taught to avoid prescribing controlled medications whenever possible.

“Initially this attitude made sense to me,” says Dr. O’Kane, “but as I became an experienced physician – and patient – I saw the harm that such an attitude could cause. Patients on controlled medication long-term were often viewed as drug-seekers and treated as such, even if their regimen was largely regarded as appropriate. Likewise, those who could benefit from short-term controlled prescriptions were sometimes denied them because of their clinician’s fear.”

Today, Dr. O’Kane believes controlled medications should seldom be the first option for patients suffering pain, anxiety, or insomnia. But, she says, “they should remain on the table and without judgment for those who fail first-line treatment or for whom alternatives are contraindicated.”

Amy Baxter, MD, believes that the amount of time spent on pain education in school needs to change.

“Doctors in the U.S. get only 12 hours of pain education, and most of it is on pharmacology,” says Dr. Baxter, who graduated from med school in 1995. “In addition to incorrect information on home opioids and addiction, I was left with the impression that medication could treat chronic pain. I now have a completely different understanding of pain as a whole-brain warning system. The goal shouldn’t be pain-free, just more comfortable.”
 

Practice lifestyle and preventive medicine

Dolapo Babalola, MD, went to medical school eager to learn how to care for the human body and her family members’ illnesses, such as the debilitating effects of arthritic pain and other chronic diseases.

“I was taught the pathology behind arthritic pain, symptoms, signs, and treatment – that it has a genetic component and is inevitable to avoid – but nothing about how to prevent it,” says Dr. Babalola, a 2000 graduate.

Twenty years later, she discovered lifestyle medicine when she began to experience knee pain.

“I was introduced to the power of health restoration by discovering the root cause of diseases such as inflammation, hormonal imbalance, and insulin resistance due to poor lifestyle choices such as diet, inactivity, stress, inadequate sleep, and substance abuse,” she says.

Adebisi Alli, DO, who graduated in 2011, remembers being taught to treat type 2 diabetes by delaying progression rather than aiming for remission. But today, “lifestyle-led, team-based approaches are steadily becoming a first prescription across medical training with the goal to put diabetes in remission,” she says.
 

Patient care is at the core of medicine

Tracey O’Connell, MD, recalls her radiology residency in the early to mid-90s, when radiologists were integral to the health care team.

“We interacted with referrers and followed the course of patients’ diseases,” says Dr. O’Connell. “We knew patient histories, their stories. We were connected to other humans, doctors, nurses, teams, and the patients themselves.”

But with the advent of picture archiving and communication systems, high-speed CT and MRI, digital radiography, and voice recognition, the practice of radiology has changed dramatically.

“There’s no time to review or discuss cases anymore,” she says. “Reports went from eloquent and articulate documents with lists of differential diagnoses to short checklists and templates. The whole field of patient care has become dehumanizing, exactly the opposite of what humans need.”

Mache Seibel, MD, who graduated almost 50 years ago, agrees that patient care has lost its focus, to the detriment of patients.

“What I learned in medical school that is forgotten today is how to listen to patients, take a history, and do an examination using my hands and a stethoscope,” says Dr. Seibel. “Today with technology and time constraints, the focus is too much on the symptom without context, ordering a test, and getting the EMR boxes filled out.”
 

Physician, heal thyself

Priya Radhakrishnan, MD, remembers learning that a physician’s well-being was their responsibility. “We now know that well-being is the health system’s responsibility and that we need to diagnose ourselves and support each other, especially our trainees,” says Dr. Radhakrishna. She graduated in 1992. “Destigmatizing mental health is essential to well-being.”

Rachel Miller, MD, a 2009 med school graduate was taught that learning about health care systems and policy wasn’t necessary. Dr. Miller says they learned that policy knowledge would come in time. “I currently disagree. It is vital to understand aspects of health care systems and policy. Not knowing these things has partly contributed to the pervasiveness of burnout among physicians and other health care providers.”
 

Practice with gender at the forefront

Janice L. Werbinski, MD, an ob.gyn., and Elizabeth Anne Comen, MD, a breast cancer oncologist, remember when nearly all medical research was performed on the 140-lb White man. Doctors learned to treat patients through that male lens.

“The majority of the anatomy we saw in medical school was on a male figure,” says Dr. Comen, author of “All in Her Head,” a HarperCollins book slated to be released in February 2024. She graduated from med school in 2004. “The only time we saw anatomy for females was in the female reproductive system. That’s changing for the better.”

Dr. Werbinski chose a residency in obstetrics and gynecology in 1975 because she thought it was the only way she could serve female patients.

“I really thought that was the place for women’s health,” says Dr. Werbinski, cochair of the American Medical Women’s Association Sex & Gender Health Coalition.

“I am happy to say that significant awareness has grown since I graduated from medical school. I hope that when this question is asked of current medical students, they will be able to say that they know to practice with a sex- and gender-focused lens.”
 

Talk about racial disparities

John McHugh, MD, an ob.gyn., recalls learning little about the social determinants of health when he attended med school more than 30 years ago.

“We saw disparities in outcomes based on race and class but assumed that we would overcome them when we were in practice,” says Dr. McHugh, an AMWA Action Coalition for Equity member. “We didn’t understand the root causes of disparities and had never heard of concepts like epigenetics or weathering. I’m hopeful current research will help our understanding and today’s medical students will serve a safer, healthier, and more equitable world.”

Curtiland Deville, MD, an associate professor of radiation oncology, recalls having few conversations around race; racial disparities; and diversity, equity, and inclusion.

“When I went to medical school, it often felt like you weren’t supposed to talk about the differences in race,” says Dr. Deville, who graduated in 2005. But today, in the post-2020 era between COVID, during which health disparities got highlighted, and calls for racial justice taking center stage, Dr. Deville says many of the things they didn’t talk about have come to the forefront in our medical institutions.
 

Information at your fingertips

For Paru David, MD, a 1996 graduate, the most significant change is the amount of health and medical information available today. “Before, the information that was taught in medical school was obtained through textbooks or within journal articles,” says Dr. David.

“Now, we have databases of information. The key to success is being able to navigate the information available to us, digest it with a keen eye, and then apply it to patient care in a timely manner.”

A version of this article first appeared on Medscape.com.

Medical education has changed drastically over the years. As theories and practices continue to change, what was once standard 10 or 20 years ago has been replaced with newer ideologies, processes, or technology. It seems likely, then, that you may disagree with some of the things that you learned as medical school has evolved.

This news organization asked physicians what they learned in med school that they now contest. Many of their answers include newer philosophies and practice methods.
 

Treat appropriately for pain

Jacqui O’Kane, DO, a 2013 med school graduate, was taught to avoid prescribing controlled medications whenever possible.

“Initially this attitude made sense to me,” says Dr. O’Kane, “but as I became an experienced physician – and patient – I saw the harm that such an attitude could cause. Patients on controlled medication long-term were often viewed as drug-seekers and treated as such, even if their regimen was largely regarded as appropriate. Likewise, those who could benefit from short-term controlled prescriptions were sometimes denied them because of their clinician’s fear.”

Today, Dr. O’Kane believes controlled medications should seldom be the first option for patients suffering pain, anxiety, or insomnia. But, she says, “they should remain on the table and without judgment for those who fail first-line treatment or for whom alternatives are contraindicated.”

Amy Baxter, MD, believes that the amount of time spent on pain education in school needs to change.

“Doctors in the U.S. get only 12 hours of pain education, and most of it is on pharmacology,” says Dr. Baxter, who graduated from med school in 1995. “In addition to incorrect information on home opioids and addiction, I was left with the impression that medication could treat chronic pain. I now have a completely different understanding of pain as a whole-brain warning system. The goal shouldn’t be pain-free, just more comfortable.”
 

Practice lifestyle and preventive medicine

Dolapo Babalola, MD, went to medical school eager to learn how to care for the human body and her family members’ illnesses, such as the debilitating effects of arthritic pain and other chronic diseases.

“I was taught the pathology behind arthritic pain, symptoms, signs, and treatment – that it has a genetic component and is inevitable to avoid – but nothing about how to prevent it,” says Dr. Babalola, a 2000 graduate.

Twenty years later, she discovered lifestyle medicine when she began to experience knee pain.

“I was introduced to the power of health restoration by discovering the root cause of diseases such as inflammation, hormonal imbalance, and insulin resistance due to poor lifestyle choices such as diet, inactivity, stress, inadequate sleep, and substance abuse,” she says.

Adebisi Alli, DO, who graduated in 2011, remembers being taught to treat type 2 diabetes by delaying progression rather than aiming for remission. But today, “lifestyle-led, team-based approaches are steadily becoming a first prescription across medical training with the goal to put diabetes in remission,” she says.
 

Patient care is at the core of medicine

Tracey O’Connell, MD, recalls her radiology residency in the early to mid-90s, when radiologists were integral to the health care team.

“We interacted with referrers and followed the course of patients’ diseases,” says Dr. O’Connell. “We knew patient histories, their stories. We were connected to other humans, doctors, nurses, teams, and the patients themselves.”

But with the advent of picture archiving and communication systems, high-speed CT and MRI, digital radiography, and voice recognition, the practice of radiology has changed dramatically.

“There’s no time to review or discuss cases anymore,” she says. “Reports went from eloquent and articulate documents with lists of differential diagnoses to short checklists and templates. The whole field of patient care has become dehumanizing, exactly the opposite of what humans need.”

Mache Seibel, MD, who graduated almost 50 years ago, agrees that patient care has lost its focus, to the detriment of patients.

“What I learned in medical school that is forgotten today is how to listen to patients, take a history, and do an examination using my hands and a stethoscope,” says Dr. Seibel. “Today with technology and time constraints, the focus is too much on the symptom without context, ordering a test, and getting the EMR boxes filled out.”
 

Physician, heal thyself

Priya Radhakrishnan, MD, remembers learning that a physician’s well-being was their responsibility. “We now know that well-being is the health system’s responsibility and that we need to diagnose ourselves and support each other, especially our trainees,” says Dr. Radhakrishna. She graduated in 1992. “Destigmatizing mental health is essential to well-being.”

Rachel Miller, MD, a 2009 med school graduate was taught that learning about health care systems and policy wasn’t necessary. Dr. Miller says they learned that policy knowledge would come in time. “I currently disagree. It is vital to understand aspects of health care systems and policy. Not knowing these things has partly contributed to the pervasiveness of burnout among physicians and other health care providers.”
 

Practice with gender at the forefront

Janice L. Werbinski, MD, an ob.gyn., and Elizabeth Anne Comen, MD, a breast cancer oncologist, remember when nearly all medical research was performed on the 140-lb White man. Doctors learned to treat patients through that male lens.

“The majority of the anatomy we saw in medical school was on a male figure,” says Dr. Comen, author of “All in Her Head,” a HarperCollins book slated to be released in February 2024. She graduated from med school in 2004. “The only time we saw anatomy for females was in the female reproductive system. That’s changing for the better.”

Dr. Werbinski chose a residency in obstetrics and gynecology in 1975 because she thought it was the only way she could serve female patients.

“I really thought that was the place for women’s health,” says Dr. Werbinski, cochair of the American Medical Women’s Association Sex & Gender Health Coalition.

“I am happy to say that significant awareness has grown since I graduated from medical school. I hope that when this question is asked of current medical students, they will be able to say that they know to practice with a sex- and gender-focused lens.”
 

Talk about racial disparities

John McHugh, MD, an ob.gyn., recalls learning little about the social determinants of health when he attended med school more than 30 years ago.

“We saw disparities in outcomes based on race and class but assumed that we would overcome them when we were in practice,” says Dr. McHugh, an AMWA Action Coalition for Equity member. “We didn’t understand the root causes of disparities and had never heard of concepts like epigenetics or weathering. I’m hopeful current research will help our understanding and today’s medical students will serve a safer, healthier, and more equitable world.”

Curtiland Deville, MD, an associate professor of radiation oncology, recalls having few conversations around race; racial disparities; and diversity, equity, and inclusion.

“When I went to medical school, it often felt like you weren’t supposed to talk about the differences in race,” says Dr. Deville, who graduated in 2005. But today, in the post-2020 era between COVID, during which health disparities got highlighted, and calls for racial justice taking center stage, Dr. Deville says many of the things they didn’t talk about have come to the forefront in our medical institutions.
 

Information at your fingertips

For Paru David, MD, a 1996 graduate, the most significant change is the amount of health and medical information available today. “Before, the information that was taught in medical school was obtained through textbooks or within journal articles,” says Dr. David.

“Now, we have databases of information. The key to success is being able to navigate the information available to us, digest it with a keen eye, and then apply it to patient care in a timely manner.”

A version of this article first appeared on Medscape.com.

Medical education has changed drastically over the years. As theories and practices continue to change, what was once standard 10 or 20 years ago has been replaced with newer ideologies, processes, or technology. It seems likely, then, that you may disagree with some of the things that you learned as medical school has evolved.

This news organization asked physicians what they learned in med school that they now contest. Many of their answers include newer philosophies and practice methods.
 

Treat appropriately for pain

Jacqui O’Kane, DO, a 2013 med school graduate, was taught to avoid prescribing controlled medications whenever possible.

“Initially this attitude made sense to me,” says Dr. O’Kane, “but as I became an experienced physician – and patient – I saw the harm that such an attitude could cause. Patients on controlled medication long-term were often viewed as drug-seekers and treated as such, even if their regimen was largely regarded as appropriate. Likewise, those who could benefit from short-term controlled prescriptions were sometimes denied them because of their clinician’s fear.”

Today, Dr. O’Kane believes controlled medications should seldom be the first option for patients suffering pain, anxiety, or insomnia. But, she says, “they should remain on the table and without judgment for those who fail first-line treatment or for whom alternatives are contraindicated.”

Amy Baxter, MD, believes that the amount of time spent on pain education in school needs to change.

“Doctors in the U.S. get only 12 hours of pain education, and most of it is on pharmacology,” says Dr. Baxter, who graduated from med school in 1995. “In addition to incorrect information on home opioids and addiction, I was left with the impression that medication could treat chronic pain. I now have a completely different understanding of pain as a whole-brain warning system. The goal shouldn’t be pain-free, just more comfortable.”
 

Practice lifestyle and preventive medicine

Dolapo Babalola, MD, went to medical school eager to learn how to care for the human body and her family members’ illnesses, such as the debilitating effects of arthritic pain and other chronic diseases.

“I was taught the pathology behind arthritic pain, symptoms, signs, and treatment – that it has a genetic component and is inevitable to avoid – but nothing about how to prevent it,” says Dr. Babalola, a 2000 graduate.

Twenty years later, she discovered lifestyle medicine when she began to experience knee pain.

“I was introduced to the power of health restoration by discovering the root cause of diseases such as inflammation, hormonal imbalance, and insulin resistance due to poor lifestyle choices such as diet, inactivity, stress, inadequate sleep, and substance abuse,” she says.

Adebisi Alli, DO, who graduated in 2011, remembers being taught to treat type 2 diabetes by delaying progression rather than aiming for remission. But today, “lifestyle-led, team-based approaches are steadily becoming a first prescription across medical training with the goal to put diabetes in remission,” she says.
 

Patient care is at the core of medicine

Tracey O’Connell, MD, recalls her radiology residency in the early to mid-90s, when radiologists were integral to the health care team.

“We interacted with referrers and followed the course of patients’ diseases,” says Dr. O’Connell. “We knew patient histories, their stories. We were connected to other humans, doctors, nurses, teams, and the patients themselves.”

But with the advent of picture archiving and communication systems, high-speed CT and MRI, digital radiography, and voice recognition, the practice of radiology has changed dramatically.

“There’s no time to review or discuss cases anymore,” she says. “Reports went from eloquent and articulate documents with lists of differential diagnoses to short checklists and templates. The whole field of patient care has become dehumanizing, exactly the opposite of what humans need.”

Mache Seibel, MD, who graduated almost 50 years ago, agrees that patient care has lost its focus, to the detriment of patients.

“What I learned in medical school that is forgotten today is how to listen to patients, take a history, and do an examination using my hands and a stethoscope,” says Dr. Seibel. “Today with technology and time constraints, the focus is too much on the symptom without context, ordering a test, and getting the EMR boxes filled out.”
 

Physician, heal thyself

Priya Radhakrishnan, MD, remembers learning that a physician’s well-being was their responsibility. “We now know that well-being is the health system’s responsibility and that we need to diagnose ourselves and support each other, especially our trainees,” says Dr. Radhakrishna. She graduated in 1992. “Destigmatizing mental health is essential to well-being.”

Rachel Miller, MD, a 2009 med school graduate was taught that learning about health care systems and policy wasn’t necessary. Dr. Miller says they learned that policy knowledge would come in time. “I currently disagree. It is vital to understand aspects of health care systems and policy. Not knowing these things has partly contributed to the pervasiveness of burnout among physicians and other health care providers.”
 

Practice with gender at the forefront

Janice L. Werbinski, MD, an ob.gyn., and Elizabeth Anne Comen, MD, a breast cancer oncologist, remember when nearly all medical research was performed on the 140-lb White man. Doctors learned to treat patients through that male lens.

“The majority of the anatomy we saw in medical school was on a male figure,” says Dr. Comen, author of “All in Her Head,” a HarperCollins book slated to be released in February 2024. She graduated from med school in 2004. “The only time we saw anatomy for females was in the female reproductive system. That’s changing for the better.”

Dr. Werbinski chose a residency in obstetrics and gynecology in 1975 because she thought it was the only way she could serve female patients.

“I really thought that was the place for women’s health,” says Dr. Werbinski, cochair of the American Medical Women’s Association Sex & Gender Health Coalition.

“I am happy to say that significant awareness has grown since I graduated from medical school. I hope that when this question is asked of current medical students, they will be able to say that they know to practice with a sex- and gender-focused lens.”
 

Talk about racial disparities

John McHugh, MD, an ob.gyn., recalls learning little about the social determinants of health when he attended med school more than 30 years ago.

“We saw disparities in outcomes based on race and class but assumed that we would overcome them when we were in practice,” says Dr. McHugh, an AMWA Action Coalition for Equity member. “We didn’t understand the root causes of disparities and had never heard of concepts like epigenetics or weathering. I’m hopeful current research will help our understanding and today’s medical students will serve a safer, healthier, and more equitable world.”

Curtiland Deville, MD, an associate professor of radiation oncology, recalls having few conversations around race; racial disparities; and diversity, equity, and inclusion.

“When I went to medical school, it often felt like you weren’t supposed to talk about the differences in race,” says Dr. Deville, who graduated in 2005. But today, in the post-2020 era between COVID, during which health disparities got highlighted, and calls for racial justice taking center stage, Dr. Deville says many of the things they didn’t talk about have come to the forefront in our medical institutions.
 

Information at your fingertips

For Paru David, MD, a 1996 graduate, the most significant change is the amount of health and medical information available today. “Before, the information that was taught in medical school was obtained through textbooks or within journal articles,” says Dr. David.

“Now, we have databases of information. The key to success is being able to navigate the information available to us, digest it with a keen eye, and then apply it to patient care in a timely manner.”

A version of this article first appeared on Medscape.com.

Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board (power source path).

“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.

The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.

The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.

The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.

On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.

Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.

Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.

The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.

Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
 

A version of this article appeared on Medscape.com.

Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board (power source path).

“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.

The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.

The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.

The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.

On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.

Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.

Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.

The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.

Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
 

A version of this article appeared on Medscape.com.

Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board (power source path).

“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.

The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.

The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.

The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.

On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.

Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.

Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.

The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.

Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
 

A version of this article appeared on Medscape.com.

TOPLINE:

• No associations were found between preoperative A1c levels and postoperative infection, wound, or ketosis complications in children with type 1 or type 2 diabetes undergoing elective noncardiac surgery or diagnostic procedures.
• Delaying elective surgeries until A1c is consistently normalized may not be warranted, particularly because this is challenging to accomplish rapidly.

METHODOLOGY:

• A retrospective analysis was done of data from surgery and endocrinology medical records of 438 children aged 1-18 years with type 1 (72%) or type 2 diabetes (28%) undergoing elective noncardiac surgery at Texas Children’s Hospital, January 2011 to June 2021.
• Overall, 28% had an A1c less than 7.0%, 42% had A1c 7%-9%, and 30% had A1c greater than 9%.
• The primary outcome was defined as a new-onset postoperative systemic infection, wound complication, or ketosis.

TAKEAWAY:

• The incidence of any postoperative systemic infections was 0.91% (n = 4); postoperative wound disruption, 3.33% (n = 19); and postoperative ketosis, 3.89% (n = 17).
• A1c levels were not associated with any postoperative systemic infections, wound complications, or ketosis.
• No other preoperative factors, including diabetes type, body mass index, or procedure type, were association with these complications.

IN PRACTICE:

“Current recommendations suggest consulting with the diabetes team before surgery and if glycemic status is suboptimal to consider delaying surgery and, if surgery cannot be delayed, considering admission to the hospital before surgery for acute optimization of glycemia, However, there is no guidance on the level of elevated A1c that should prompt consideration of delaying surgery. This issue is of crucial importance because necessary elective surgery or diagnostic procedures may be delayed unnecessarily or for longer than needed in children with elevated A1c because of the difficulty of improving A1c levels rapidly.”

STUDY DETAILS:

The study was led by Grace Kim, MD, of the division of diabetes and endocrinology, Texas Children’s Hospital, Houston. It was published online August 1, 2023, in Diabetes Care.

LIMITATIONS:

• The postoperative complication rate was low.
• Only elective procedures were included.

DISCLOSURES:

The authors have no disclosures.

A version of this article first appeared on Medscape.com.

TOPLINE:

• No associations were found between preoperative A1c levels and postoperative infection, wound, or ketosis complications in children with type 1 or type 2 diabetes undergoing elective noncardiac surgery or diagnostic procedures.
• Delaying elective surgeries until A1c is consistently normalized may not be warranted, particularly because this is challenging to accomplish rapidly.

METHODOLOGY:

• A retrospective analysis was done of data from surgery and endocrinology medical records of 438 children aged 1-18 years with type 1 (72%) or type 2 diabetes (28%) undergoing elective noncardiac surgery at Texas Children’s Hospital, January 2011 to June 2021.
• Overall, 28% had an A1c less than 7.0%, 42% had A1c 7%-9%, and 30% had A1c greater than 9%.
• The primary outcome was defined as a new-onset postoperative systemic infection, wound complication, or ketosis.

TAKEAWAY:

• The incidence of any postoperative systemic infections was 0.91% (n = 4); postoperative wound disruption, 3.33% (n = 19); and postoperative ketosis, 3.89% (n = 17).
• A1c levels were not associated with any postoperative systemic infections, wound complications, or ketosis.
• No other preoperative factors, including diabetes type, body mass index, or procedure type, were association with these complications.

IN PRACTICE:

“Current recommendations suggest consulting with the diabetes team before surgery and if glycemic status is suboptimal to consider delaying surgery and, if surgery cannot be delayed, considering admission to the hospital before surgery for acute optimization of glycemia, However, there is no guidance on the level of elevated A1c that should prompt consideration of delaying surgery. This issue is of crucial importance because necessary elective surgery or diagnostic procedures may be delayed unnecessarily or for longer than needed in children with elevated A1c because of the difficulty of improving A1c levels rapidly.”

STUDY DETAILS:

The study was led by Grace Kim, MD, of the division of diabetes and endocrinology, Texas Children’s Hospital, Houston. It was published online August 1, 2023, in Diabetes Care.

LIMITATIONS:

• The postoperative complication rate was low.
• Only elective procedures were included.

DISCLOSURES:

The authors have no disclosures.

A version of this article first appeared on Medscape.com.

TOPLINE:

• No associations were found between preoperative A1c levels and postoperative infection, wound, or ketosis complications in children with type 1 or type 2 diabetes undergoing elective noncardiac surgery or diagnostic procedures.
• Delaying elective surgeries until A1c is consistently normalized may not be warranted, particularly because this is challenging to accomplish rapidly.

METHODOLOGY:

• A retrospective analysis was done of data from surgery and endocrinology medical records of 438 children aged 1-18 years with type 1 (72%) or type 2 diabetes (28%) undergoing elective noncardiac surgery at Texas Children’s Hospital, January 2011 to June 2021.
• Overall, 28% had an A1c less than 7.0%, 42% had A1c 7%-9%, and 30% had A1c greater than 9%.
• The primary outcome was defined as a new-onset postoperative systemic infection, wound complication, or ketosis.

TAKEAWAY:

• The incidence of any postoperative systemic infections was 0.91% (n = 4); postoperative wound disruption, 3.33% (n = 19); and postoperative ketosis, 3.89% (n = 17).
• A1c levels were not associated with any postoperative systemic infections, wound complications, or ketosis.
• No other preoperative factors, including diabetes type, body mass index, or procedure type, were association with these complications.

IN PRACTICE:

“Current recommendations suggest consulting with the diabetes team before surgery and if glycemic status is suboptimal to consider delaying surgery and, if surgery cannot be delayed, considering admission to the hospital before surgery for acute optimization of glycemia, However, there is no guidance on the level of elevated A1c that should prompt consideration of delaying surgery. This issue is of crucial importance because necessary elective surgery or diagnostic procedures may be delayed unnecessarily or for longer than needed in children with elevated A1c because of the difficulty of improving A1c levels rapidly.”

STUDY DETAILS:

The study was led by Grace Kim, MD, of the division of diabetes and endocrinology, Texas Children’s Hospital, Houston. It was published online August 1, 2023, in Diabetes Care.

LIMITATIONS:

• The postoperative complication rate was low.
• Only elective procedures were included.

DISCLOSURES:

The authors have no disclosures.

A version of this article first appeared on Medscape.com.