A viewpoint from Associate Professor Gloria Salazar, MD, FSIR, thought leader, Chief of Vascular Interventional Radiology at the University of Nort...
A viewpoint from Associate Professor Gloria Salazar, MD, FSIR, thought leader, Chief of Vascular Interventional Radiology at the University of North Carolina at Chapel Hill, and Chair for the Women's Clinical Council at Society Interventional Radiology USA (SIR). The purpose of this article is to identify and understand current clinical challenges within Interventional Radiology with a focus on Women's Health.
I am the Chief of Vascular Interventional Radiology at the University of North Carolina at Chapel Hill and have been a practicing physician for twelve years. I have worked with women's health my entire career, starting as a fellow who trained with several experts in my area. I learned from the early innovators in the field of Uterine Artery Embolization (UAE) and have strived to further this specialty and, in turn, pass on the knowledge to new generations. When I moved my practice to Mass General Hospital, I developed a multidisciplinary fibroid clinic with gynecologists to focus on the complete patient workflow: from the onset of the clinical diagnosis to recovery and providing a better quality of life for the patient.
Women's health is a subject that I am very passionate about, and I have taken an educational role in the women's health community and the national Society of Interventional Radiology (SIR). UAE has been in place for over thirty years, and we have learned a lot about which patients benefit the most from the procedure and refined the techniques. Given the abundant data on UAE compared to surgical alternatives, in the year 2022, we know exactly what to expect in terms of clinical outcomes and the benefits it offers to our patients.
1. A uterus-preserving and non-surgical option for treating symptomatic fibroids
What is UAE, who benefits from it, and what are the alternatives? The importance of making an informed decision and choosing a fibroid treatment option based on lifestyle and desired outcome.
2. Access to UAE: patient awareness and global adoption
How to overcome the challenges of patient awareness and increase patient involvement in the medical decision-making with education, patient advocacy campaigns, and collaboration between society, primary care, and family physicians.
3. Value of simulation for improving communication, proficiency, and adoption of UAE
Simulation can help increase the adoption of UAE through three critical uses: Efficient IR onboarding, advanced training, and team training & rehearsal.
UAE has been extensively researched within the Interventional Radiology (IR) portfolio, and there have been randomized comparative trials with alternative treatments such as open surgery, i.e., hysterectomy and myomectomy. Therefore, research supports the fact that UAE is an excellent treatment option for patients experiencing heavy bleedings as well as bulk-related symptoms due to fibroids. The treatment is also suitable for patients who experience other symptoms that affect the quality of life, such as fatigue and sexual dysfunction. Through thirty years of research, we can provide the global IR community with a non-surgical procedure (minimally invasive vs. open surgery) that preserves the uterus instead of removing it.
"The last couple of years have taught me that the treatment decision is a joint decision between the patient and physician. What is the patient looking for in terms of outcome? This is called shared medical decision-making"
In my clinical practice, women are introduced to the different treatment alternatives and can choose an option based on their lifestyle. One specific example comes from my experience with the Hispanic patient population. Even though they tend to have large fibroids and large uteruses due to fibroids, these women still prefer not to remove the uterus. In this population, culture is the main reason for not undergoing hysterectomy. Secondly, to maintain their femininity. These aspects of women's health seem to have been forgotten during studies and trials, even though they are essential factors for patients to include in their decision-making.
I want to highlight that hysterectomy and myomectomy are still needed in some cases, especially myomectomy for patients who wish to preserve their fertility and become pregnant. According to recent data, UAE can be a comparable option depending on the patient selection. We have seen patients become pregnant after UAE, with safe pregnancies and healthy babies. Yet existing data is still not 100% favorable for UAE. This is another area in which we work with the patients to inform and collect further data for evaluation.
For the young patients visiting my practice who wish to become pregnant and undergo UAE, I present statistics from the most recent trials comparing myomectomy and UAE (the FEMME trial). The results showed a slightly higher percentage of women getting pregnant after the UAE procedure, even though the study was not designed to prove so. When patients look at these studies, they see percentages and wonder: Why should I have a myomectomy? Why should I not get a UAE? From a patient perspective, there is a lot of data to analyze, and there are many options. The best approach for the patient is to look at the safety profile for each procedure and enable them to choose and be fully informed about their options.
As the Chair of the Women's Clinical Council at SIR, I am looking at these challenges. UAE is a significant and comparable procedure to other alternatives; patient awareness is the problem. There is an article called Improving Access to UFE: What Are the Barriers? by Dr. Claire Kaufman in the January 2022 issue of Endovascular Today, which specifically addresses this challenge. I was a guest editor for this Endovascular Today issue, which we devoted entirely to women's health, including UAE, PAD, and other areas.
Explore Endovascular Today with guest editors
Gloria Salazar, MD, & Kirema Garcia-Reyes, MD: January 2022: Women’s Health & Vascular Intervention
There are still gaps in Women's Health within the United States, and it is vital to highlight and discuss these issues. Data shows that most patients with fibroids are still undergoing hysterectomies in rural areas of the US. This shows limited access to care and a lack of awareness altogether. SIR performed an evaluation where the results showed that many women in the US are unfamiliar with UAE and believe that removing the uterus is the only option. Women still do not know about this treatment option, even though it has been in place for thirty years, indicating a great need for education. There is plenty of work left to do to raise patients' awareness.
The US differs from other countries when it comes to patient care patterns. The primary care physicians take on a lot of women's health care cases. The primary care physicians are overwhelmingly busy, making it difficult for them to keep up with all the new developments within treatments for specific conditions such as fibroids.
Another factor for consideration is the patient's access to an IR. Some IR practices may encounter challenges in reaching out to the patients who require alternative treatments for fibroids, depending on their locations (rural vs. urban areas). The underserved or rural areas in the US are likely to have only one or two IRs, and UAE is not going to be a priority for these centers. If these centers get too busy with trauma emergencies, they cannot build a program to serve patients with conditions such as fibroids.
SIR is currently working on identifying and prioritizing the needs of different patient populations. When looking at patient needs, there is also PAD. PAD has an extremely high rate of limb amputations for Hispanics and African-Americans in the US. It is important to state that women today need to have a choice and to be involved in the treatment decision.
Since hysterectomy is major surgery associated with potentially significant complications, it should not be the only option offered for women. Today we know more about the impact of hysterectomy on women's mental health. Women undergoing hysterectomy for benign conditions can develop mental health issues after the procedure. We must prioritize this topic as a public health issue to make a difference; however, it might be difficult with the ongoing pandemic as the current global focus.
Developing shared medical decision tools to provide the patient with all the treatment options is an essential step in the right direction. Increasing awareness is something we must work with as a society, together with the primary care and family physicians. Patient advocacy campaigns will also be important to get the patients who have undergone a UAE to speak up and attest to the fact that there is an alternative to removing the uterus. The awareness is increasing at a governmental level in the US, which is great. There is a new law about to be implemented focusing on the research and awareness of fibroids.
Fibroids are also a prevalent condition among the African American population, an underrepresented patient population in terms of medical care. There is a lot of work to be done there. It is vital to educate about the procedure and collaborate with gynecologists and primary care physicians who meet these patients daily to increase awareness.
Where I am based right now, we are very fortunate to have a fantastic RAD-AID-supported Global Health Program for education in radiology. RAD-AID is a great organization with many good people performing the pioneering work when it comes to access. However, more programs must be developed. Instead of one general program, it could be advantageous to create disease-specific programs, similar to the ongoing global Stroke Program and the focus on continuous proficiency-based learning. As the fellows already have graduated, they need to build their expertise within different disease areas and procedures. To set up the educational program, we must define a leader, a training program supervisor, and what equipment and tools are needed. A program like this is preferably centered around simulation training.
While cancer is a major issue in society and will continue to be so until we can find a cure, there are also benign conditions that have a significant negative impact on society. According to available data, there is a substantial negative economic impact and a high number of workdays missed, and this data is only based on fibroids.
A critical perspective that needs to be considered is how fibroids affect the quality of life beyond medical needs. As such, the functional status of women today is different from fifty years ago; women are now working, and many are single mothers raising families on their own. A symptomatic fibroid can hinder a woman's ability to work because of bleeding issues, and the pain can make her nonfunctioning as a mother. There are single moms with debilitating fibroids that cannot afford not to work; they must work to provide for their families. A condition like this has a huge impact on women's quality of life and society.
Current gaps in women's health research and the lack of treatment awareness and adoption of UAE can potentially impact maternal mortality worldwide. UAE could help decrease maternal mortality if used to treat postpartum hemorrhage. However, still, patients are not being referred to this procedure in the emergency setting, not even in the US.
A focus on multidisciplinary efforts is required to access all valuable research from the gynecologists' perspective and work together to identify priorities for action. This approach is currently being evaluated by medical societies and leaders in the field.
Simulation has an essential role in this context, enabling physicians to stay proficient. There are two ways to increase access to UAE: improve the training of IRs that already know the basics of the procedure and provide onboarding training for physicians in countries where they lack the basic knowledge of UAE. Two years ago, SIR ran an outreach program in El Salvador. The purpose was to train physicians in Central America, where there are only one or two IRs per country. With the right proctoring from senior experts, simulation can play an important role in increasing the adoption and proficiency of UAE. The best way to move forward is to help build these IR teams worldwide.
There are three areas of use where simulation has been valuable. First, it can easily be incorporated into resident and training programs as an onboarding toolkit. We are now doing an integrated pathway through educational programs, where proficiency is measured at different levels. Studies presented at SIR in the past years show that the more hands-on procedural experience you have, the less radiation you will use when performing a UAE. This is comparable to simulation. Simulation training will increase the preparedness for treating real patients. By performing a simulated procedure with expert guidance, your knowledge will have multiplied. It is important to note that simulation does not replace real training but instead should be used to accelerate proficiency and mitigate patient procedural complications.
The second area of use is advanced training, either to learn new innovative procedures or to practice different approaches for complex interventions. I have been practicing for over ten years, and simulation can help junior physicians reach that level faster. The best example in this category relates to the increased use of the transradial approach in IR. Historically, physicians have been utilizing transfemoral access for arterial interventions and had to switch to a different technique. The same applies to outreach at beginner and intermediate levels; IRs might need a refresher similar to the program we did with SIR Giveback Program in El Salvador. For example, if IRs would like to start a fibroid program in Central America, simulation can be a valuable educational tool.
The third area of use, which I am most excited about, is team training. Simulation enables physicians to rehearse and prepare for the unexpected. Some examples include high-risk anesthesia IR cases, a multidisciplinary response for traumas, and postpartum bleeding patients. Team training with simulators can help teams prepare for time-sensitive emergencies, maintain proficiency, and increase staff confidence. Team training on the simulator allows us to discuss and reflect on different approaches and ultimately improve patient outcomes.
One of the first cases I did at UNC included a patient with placenta accreta who had a tremendously high risk of bleeding during the C-section. What we did, in this case, was to insert the balloons, the baby was delivered, and then we went back in and embolized, reset the uterus, closed the patient, and then the patient went back to the floor. The patient did not stay in the ICU for more than one day. To prepare for this complex procedure, we trained together as a team. The successful outcome is a result of great teamwork and workflow. Rehearsal is important, and you do not want to practice on a real patient. Simulation is, therefore, key to this type of training. These are high-risk procedures for young women, and the risk of bleeding due to placenta accreta could be as high as 10-20%.
There are still some patients with placenta accreta that will require a hysterectomy. One way to save the uterus from postpartum bleeding and avoid hysterectomy is to perform an embolization. In another scenario, you might still have to do a hysterectomy if the placenta penetrates the bladder, sometimes even in the pelvis. In that case, a hysterectomy will lead to fewer comorbidities, less bleeding, and more control.
That would depend on the regional area, and the number of high-risk pregnancies admitted to the hospital. It needs to be discussed locally, as it is the hospital's responsibility. That is my role here. Maternal mortality is still an issue everywhere globally, and therefore a simulator like this would not go to waste. Research is essential here, and if you can demonstrate improved outcomes, I believe that people will follow.
I would love to have that type of simulator at my institution since we get a lot of high-risk pregnancies. Simulation-based team training would be valuable for the whole staff and would enable everyone to understand their role and how to manage complications. They have a great rapid response team just for high-risk obstetrics in Mexico. They train their whole staff every year.
Having a simulator to support your staff and the training program would be advantageous. It could be a biannual simulation event where physicians come to us to train, or the simulator could be shipped to areas where we cannot travel. We could proctor them and help them build their own program. Simulation should be available for hospitals worldwide, and I believe that if we provide a simulator and our expertise, it will help expedite the learning curve.
Interested and want to learn more? Discover how Mentice can support your IR team:
References:
Why do 70% of women* not know about Uterine Artery Embolization?
*U.S. women aged 18 to 34
https://evtoday.com/articles/2022-jan/improving-access-to-ufe-what-are-the-barriers
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