The New Gastroenterologist

The AGA Trainee and Early Career Committee was formed in 2013 to address the needs of those at the beginning of their careers in gastroenterology. The committee is composed of 12 trainee and early career members, whose mission is to develop and support programs relevant to the needs of young clinicians and researchers in the field of GI. In an initial needs assessment, a survey of GI fellows/trainees was undertaken, which revealed a gap in preparation for the transition from fellowship to practice. In particular, respondents expressed a desire to better understand issues related to practice skills, including health care economics, billing/coding, contract negotiation, and health policy. In addition, some trainees felt uncomfortable bringing questions about their private practice job search to academic faculty, who in turn may not have the necessary experience to provide answers regarding various private practice models and opportunities. Furthermore, fellows have little time and opportunity to learn about the rapidly shifting health care environment that will directly affect their future GI practice. To address these unmet needs, the AGA Trainee and Early Career Committee (in partnership with the Practice Management and Economics Committee as well as the Education and Training Committee) developed a workshop to educate fellows and early career GIs about practice and employment models, contracts and negotiations, compliance, health care policy, and other pertinent topics.

These workshops were designed with a half-day curriculum and based regionally to facilitate attendance as well as to capture the local practice patterns in different regions. They were launched during the 2014-2015 academic year in three cities – Boston, Los Angeles, and Chicago – and received extremely positive feedback from participants.

Since then, 16 additional workshops have been held in the following locations: Columbus, Ohio; Philadelphia; Houston; San Diego; New York; Stanford, Calif.; Pinehurst, N.C.; and Iowa City, Iowa (simulcast). At various times, workshops were held in partnership with local societies such as the New York Society of Gastrointestinal Endoscopy, the North Carolina Society of Gastroenterology, and the Texas Society of Gastrointestinal Endoscopy, which offered additional opportunities for networking. Overall, the 19 regional practice skills workshops held over the last 4 years have reached 420 fellows and early career GIs.

Dr. Ketwaroo is assistant professor, Baylor College of Medicine, and therapeutic endoscopist, Michael E DeBakey VA Medical Center, Houston. Dr. Liang is instructor of medicine, division of gastroenterology, NYU Langone Health, and staff physician, VA New York Harbor Health Care System. Ms. Brown is senior manager of constituency programs, AGA. Ms. NuQuay is senior director, member relations and constituency programs, AGA.

The AGA Trainee and Early Career Committee was formed in 2013 to address the needs of those at the beginning of their careers in gastroenterology. The committee is composed of 12 trainee and early career members, whose mission is to develop and support programs relevant to the needs of young clinicians and researchers in the field of GI. In an initial needs assessment, a survey of GI fellows/trainees was undertaken, which revealed a gap in preparation for the transition from fellowship to practice. In particular, respondents expressed a desire to better understand issues related to practice skills, including health care economics, billing/coding, contract negotiation, and health policy. In addition, some trainees felt uncomfortable bringing questions about their private practice job search to academic faculty, who in turn may not have the necessary experience to provide answers regarding various private practice models and opportunities. Furthermore, fellows have little time and opportunity to learn about the rapidly shifting health care environment that will directly affect their future GI practice. To address these unmet needs, the AGA Trainee and Early Career Committee (in partnership with the Practice Management and Economics Committee as well as the Education and Training Committee) developed a workshop to educate fellows and early career GIs about practice and employment models, contracts and negotiations, compliance, health care policy, and other pertinent topics.

These workshops were designed with a half-day curriculum and based regionally to facilitate attendance as well as to capture the local practice patterns in different regions. They were launched during the 2014-2015 academic year in three cities – Boston, Los Angeles, and Chicago – and received extremely positive feedback from participants.

Since then, 16 additional workshops have been held in the following locations: Columbus, Ohio; Philadelphia; Houston; San Diego; New York; Stanford, Calif.; Pinehurst, N.C.; and Iowa City, Iowa (simulcast). At various times, workshops were held in partnership with local societies such as the New York Society of Gastrointestinal Endoscopy, the North Carolina Society of Gastroenterology, and the Texas Society of Gastrointestinal Endoscopy, which offered additional opportunities for networking. Overall, the 19 regional practice skills workshops held over the last 4 years have reached 420 fellows and early career GIs.

Dr. Ketwaroo is assistant professor, Baylor College of Medicine, and therapeutic endoscopist, Michael E DeBakey VA Medical Center, Houston. Dr. Liang is instructor of medicine, division of gastroenterology, NYU Langone Health, and staff physician, VA New York Harbor Health Care System. Ms. Brown is senior manager of constituency programs, AGA. Ms. NuQuay is senior director, member relations and constituency programs, AGA.

The AGA Trainee and Early Career Committee was formed in 2013 to address the needs of those at the beginning of their careers in gastroenterology. The committee is composed of 12 trainee and early career members, whose mission is to develop and support programs relevant to the needs of young clinicians and researchers in the field of GI. In an initial needs assessment, a survey of GI fellows/trainees was undertaken, which revealed a gap in preparation for the transition from fellowship to practice. In particular, respondents expressed a desire to better understand issues related to practice skills, including health care economics, billing/coding, contract negotiation, and health policy. In addition, some trainees felt uncomfortable bringing questions about their private practice job search to academic faculty, who in turn may not have the necessary experience to provide answers regarding various private practice models and opportunities. Furthermore, fellows have little time and opportunity to learn about the rapidly shifting health care environment that will directly affect their future GI practice. To address these unmet needs, the AGA Trainee and Early Career Committee (in partnership with the Practice Management and Economics Committee as well as the Education and Training Committee) developed a workshop to educate fellows and early career GIs about practice and employment models, contracts and negotiations, compliance, health care policy, and other pertinent topics.

These workshops were designed with a half-day curriculum and based regionally to facilitate attendance as well as to capture the local practice patterns in different regions. They were launched during the 2014-2015 academic year in three cities – Boston, Los Angeles, and Chicago – and received extremely positive feedback from participants.

Since then, 16 additional workshops have been held in the following locations: Columbus, Ohio; Philadelphia; Houston; San Diego; New York; Stanford, Calif.; Pinehurst, N.C.; and Iowa City, Iowa (simulcast). At various times, workshops were held in partnership with local societies such as the New York Society of Gastrointestinal Endoscopy, the North Carolina Society of Gastroenterology, and the Texas Society of Gastrointestinal Endoscopy, which offered additional opportunities for networking. Overall, the 19 regional practice skills workshops held over the last 4 years have reached 420 fellows and early career GIs.

Dr. Ketwaroo is assistant professor, Baylor College of Medicine, and therapeutic endoscopist, Michael E DeBakey VA Medical Center, Houston. Dr. Liang is instructor of medicine, division of gastroenterology, NYU Langone Health, and staff physician, VA New York Harbor Health Care System. Ms. Brown is senior manager of constituency programs, AGA. Ms. NuQuay is senior director, member relations and constituency programs, AGA.

Editor’s Note: This is the second installment of the Private Practice Perspectives column, which is a collaboration between the AGA’s The New Gastroenterologist and the Digestive Health Physicians Association (DHPA). In this issue’s column, David Ramsay (Winston Salem, N.C.) provides valuable advice on the very important topic of picking the right practice.
Bryson W. Katona, MD, PhD
Editor in Chief, The New Gastroenterologist

Just 7 years ago, I faced the same difficult decisions many new gastroenterologists have. Like many physicians coming out of a residency and fellowship program, I had loans to repay and family to consider when evaluating the choices about where I would practice.

Looking back, there were several essential questions that helped guide my decision-making process. If you are early in your career as a GI, here are some questions to ask yourself and tips that I’ve learned along the way that may help make the decision about which practice is right for you.

What do you want to do with your training and skills? This may sound obvious, but it’s important to align your interests with the right practice. Did you receive extra training in endoscopic procedures, such as endoscopic ultrasonography and endoscopic retrograde cholangiopancreatography? Do you want to specialize in inflammatory bowel disease? Have a passion for hepatology? Look for a practice that has those specific opportunities available to match your interests.

In addition, some GI docs want to pursue their interest in research. Keep in mind that many independent practices have research arms and offer physicians the opportunity to continue on this path.

Lastly, consider whether you want to be involved in the business of medicine or take on a leadership role. Many practices offer (and even encourage) those opportunities, and you can winnow down your list of practices based on whether they allow you to take on those roles.

Where do you want to live? My wife and I completed our residencies and fellowships in Washington, but when it came time to find a place to practice medicine, we knew we wanted to be near family. We narrowed our search to Tennessee, Florida, and North Carolina, where we eventually ended up.

Of course, wherever you decide to go is a personal choice. Some people prefer living on the coasts or want to reside in a major city. This might come as a surprise to some, but very often you will command a higher salary in rural areas or smaller cities, which are traditionally underserved by our profession. That starts to matter when you think about paying off your student loan debt.

What is the long-term potential of each position? This is perhaps the most important question to ask. Does your new practice offer ownership potential? Are there opportunities to share in the various (ancillary) revenue streams, such as an ambulatory surgery center, anesthesia, or pathology? How soon might you have the opportunity to buy in and what is the buy in structure and cost? What are the practice rules around offering partnerships?

These are all questions that you should ask up front. Remember that the lifestyle you start out with may change over the course of your career. Find a practice that offers opportunities for growth because your long-term income potential is much more important than your starting salary or size of any sign-on bonus.

Once you’ve decided the answers to some of these questions, here are a few tips to help you land a job at the right medical practice.

Talk to your mentors and tap into your connections: Most GI physicians completing a fellowship will have mentors who have connections to practices. Speak with them about where to look. In addition, most medical societies and state-specific GI societies post classified job listings. Use these professional memberships.

Don’t be afraid of the cold call: If you know where you might want to live, you should consider cold calls to practices in the area to see what opportunities are available. That’s how I found my job. I started calling practices in North Carolina. Those that didn’t have openings knew of, and shared names of, practices in the state that did.

Call the local hospitals and ask to speak to the charge nurse in endoscopy: This is one the best tips I got to help narrow the field. These nurses are a great source of information with honest feedback about the reputation of the local GI practices.

Look for collegiality: This can be harder to spot, but it’s a good sign when the CEOs or practice administrators are engaging and take the time to answer questions.

Look for groups that don’t have a lot of turnover: This is another important sign. We call it the churn and burn: We all know of fellows who have joined a practice where they work long hours but never have the opportunity to make partner. You might ask the question directly: How many physicians have come here and left within the first 5 years of employment? A high turnover rate is a red flag. No matter what type of practice you choose, the key is to look at your long-term prospects, not just at short-term rewards. After all, that’s what will give you the greatest opportunities – and likely make you happiest in your career.
 

David Ramsay, MD, is treasurer of the Digestive Health Physicians Association. He is President of Digestive Health Specialists in Winston Salem, N.C., which he joined in 2012 after working in the Washington area.

Editor’s Note: This is the second installment of the Private Practice Perspectives column, which is a collaboration between the AGA’s The New Gastroenterologist and the Digestive Health Physicians Association (DHPA). In this issue’s column, David Ramsay (Winston Salem, N.C.) provides valuable advice on the very important topic of picking the right practice.
Bryson W. Katona, MD, PhD
Editor in Chief, The New Gastroenterologist

Just 7 years ago, I faced the same difficult decisions many new gastroenterologists have. Like many physicians coming out of a residency and fellowship program, I had loans to repay and family to consider when evaluating the choices about where I would practice.

Looking back, there were several essential questions that helped guide my decision-making process. If you are early in your career as a GI, here are some questions to ask yourself and tips that I’ve learned along the way that may help make the decision about which practice is right for you.

What do you want to do with your training and skills? This may sound obvious, but it’s important to align your interests with the right practice. Did you receive extra training in endoscopic procedures, such as endoscopic ultrasonography and endoscopic retrograde cholangiopancreatography? Do you want to specialize in inflammatory bowel disease? Have a passion for hepatology? Look for a practice that has those specific opportunities available to match your interests.

In addition, some GI docs want to pursue their interest in research. Keep in mind that many independent practices have research arms and offer physicians the opportunity to continue on this path.

Lastly, consider whether you want to be involved in the business of medicine or take on a leadership role. Many practices offer (and even encourage) those opportunities, and you can winnow down your list of practices based on whether they allow you to take on those roles.

Where do you want to live? My wife and I completed our residencies and fellowships in Washington, but when it came time to find a place to practice medicine, we knew we wanted to be near family. We narrowed our search to Tennessee, Florida, and North Carolina, where we eventually ended up.

Of course, wherever you decide to go is a personal choice. Some people prefer living on the coasts or want to reside in a major city. This might come as a surprise to some, but very often you will command a higher salary in rural areas or smaller cities, which are traditionally underserved by our profession. That starts to matter when you think about paying off your student loan debt.

What is the long-term potential of each position? This is perhaps the most important question to ask. Does your new practice offer ownership potential? Are there opportunities to share in the various (ancillary) revenue streams, such as an ambulatory surgery center, anesthesia, or pathology? How soon might you have the opportunity to buy in and what is the buy in structure and cost? What are the practice rules around offering partnerships?

These are all questions that you should ask up front. Remember that the lifestyle you start out with may change over the course of your career. Find a practice that offers opportunities for growth because your long-term income potential is much more important than your starting salary or size of any sign-on bonus.

Once you’ve decided the answers to some of these questions, here are a few tips to help you land a job at the right medical practice.

Talk to your mentors and tap into your connections: Most GI physicians completing a fellowship will have mentors who have connections to practices. Speak with them about where to look. In addition, most medical societies and state-specific GI societies post classified job listings. Use these professional memberships.

Don’t be afraid of the cold call: If you know where you might want to live, you should consider cold calls to practices in the area to see what opportunities are available. That’s how I found my job. I started calling practices in North Carolina. Those that didn’t have openings knew of, and shared names of, practices in the state that did.

Call the local hospitals and ask to speak to the charge nurse in endoscopy: This is one the best tips I got to help narrow the field. These nurses are a great source of information with honest feedback about the reputation of the local GI practices.

Look for collegiality: This can be harder to spot, but it’s a good sign when the CEOs or practice administrators are engaging and take the time to answer questions.

Look for groups that don’t have a lot of turnover: This is another important sign. We call it the churn and burn: We all know of fellows who have joined a practice where they work long hours but never have the opportunity to make partner. You might ask the question directly: How many physicians have come here and left within the first 5 years of employment? A high turnover rate is a red flag. No matter what type of practice you choose, the key is to look at your long-term prospects, not just at short-term rewards. After all, that’s what will give you the greatest opportunities – and likely make you happiest in your career.
 

David Ramsay, MD, is treasurer of the Digestive Health Physicians Association. He is President of Digestive Health Specialists in Winston Salem, N.C., which he joined in 2012 after working in the Washington area.

Editor’s Note: This is the second installment of the Private Practice Perspectives column, which is a collaboration between the AGA’s The New Gastroenterologist and the Digestive Health Physicians Association (DHPA). In this issue’s column, David Ramsay (Winston Salem, N.C.) provides valuable advice on the very important topic of picking the right practice.
Bryson W. Katona, MD, PhD
Editor in Chief, The New Gastroenterologist

Just 7 years ago, I faced the same difficult decisions many new gastroenterologists have. Like many physicians coming out of a residency and fellowship program, I had loans to repay and family to consider when evaluating the choices about where I would practice.

Looking back, there were several essential questions that helped guide my decision-making process. If you are early in your career as a GI, here are some questions to ask yourself and tips that I’ve learned along the way that may help make the decision about which practice is right for you.

What do you want to do with your training and skills? This may sound obvious, but it’s important to align your interests with the right practice. Did you receive extra training in endoscopic procedures, such as endoscopic ultrasonography and endoscopic retrograde cholangiopancreatography? Do you want to specialize in inflammatory bowel disease? Have a passion for hepatology? Look for a practice that has those specific opportunities available to match your interests.

In addition, some GI docs want to pursue their interest in research. Keep in mind that many independent practices have research arms and offer physicians the opportunity to continue on this path.

Lastly, consider whether you want to be involved in the business of medicine or take on a leadership role. Many practices offer (and even encourage) those opportunities, and you can winnow down your list of practices based on whether they allow you to take on those roles.

Where do you want to live? My wife and I completed our residencies and fellowships in Washington, but when it came time to find a place to practice medicine, we knew we wanted to be near family. We narrowed our search to Tennessee, Florida, and North Carolina, where we eventually ended up.

Of course, wherever you decide to go is a personal choice. Some people prefer living on the coasts or want to reside in a major city. This might come as a surprise to some, but very often you will command a higher salary in rural areas or smaller cities, which are traditionally underserved by our profession. That starts to matter when you think about paying off your student loan debt.

What is the long-term potential of each position? This is perhaps the most important question to ask. Does your new practice offer ownership potential? Are there opportunities to share in the various (ancillary) revenue streams, such as an ambulatory surgery center, anesthesia, or pathology? How soon might you have the opportunity to buy in and what is the buy in structure and cost? What are the practice rules around offering partnerships?

These are all questions that you should ask up front. Remember that the lifestyle you start out with may change over the course of your career. Find a practice that offers opportunities for growth because your long-term income potential is much more important than your starting salary or size of any sign-on bonus.

Once you’ve decided the answers to some of these questions, here are a few tips to help you land a job at the right medical practice.

Talk to your mentors and tap into your connections: Most GI physicians completing a fellowship will have mentors who have connections to practices. Speak with them about where to look. In addition, most medical societies and state-specific GI societies post classified job listings. Use these professional memberships.

Don’t be afraid of the cold call: If you know where you might want to live, you should consider cold calls to practices in the area to see what opportunities are available. That’s how I found my job. I started calling practices in North Carolina. Those that didn’t have openings knew of, and shared names of, practices in the state that did.

Call the local hospitals and ask to speak to the charge nurse in endoscopy: This is one the best tips I got to help narrow the field. These nurses are a great source of information with honest feedback about the reputation of the local GI practices.

Look for collegiality: This can be harder to spot, but it’s a good sign when the CEOs or practice administrators are engaging and take the time to answer questions.

Look for groups that don’t have a lot of turnover: This is another important sign. We call it the churn and burn: We all know of fellows who have joined a practice where they work long hours but never have the opportunity to make partner. You might ask the question directly: How many physicians have come here and left within the first 5 years of employment? A high turnover rate is a red flag. No matter what type of practice you choose, the key is to look at your long-term prospects, not just at short-term rewards. After all, that’s what will give you the greatest opportunities – and likely make you happiest in your career.
 

David Ramsay, MD, is treasurer of the Digestive Health Physicians Association. He is President of Digestive Health Specialists in Winston Salem, N.C., which he joined in 2012 after working in the Washington area.

Introduction

Comprehensive training in endoscopic retrograde cholangioscopy (ERCP) and endoscopic ultrasound (EUS) is difficult to achieve within the curriculum of a standard 3-year Accreditation Council for Graduate Medical Education (ACGME)–accredited gastroenterology fellowship. ERCP and EUS are technically challenging, operator-dependent procedures that require specialized cognitive, technical, and integrative skills.^1-4 A survey of physicians performing ERCP found that only 60% felt “very comfortable” performing the procedure after completion of a standard gastroenterology fellowship.⁵ Procedural volumes in ERCP and EUS tend to be low among general gastroenterology fellows; in a survey, only 9% and 4.5% of trainees in standard gastrointestinal fellowships had anticipated volumes of more than 200 ERCP and EUS procedures, respectively.⁶ The unique skills required to safely and effectively perform ERCP and EUS, along with the growing portfolio of therapeutic procedures such as endoscopic mucosal resection (EMR), endoluminal stent placement, deep enteroscopy, advanced closure techniques, bariatric endoscopy, therapeutic EUS, and submucosal endoscopy (including endoscopic submucosal dissection and peroral endoscopic myotomy), has led to the development of dedicated postgraduate advanced endoscopy training programs.^7-9

Status of advanced endoscopy training in the United States

Advanced endoscopy fellowships are typically year-long training programs completed at tertiary care centers. Over the last 2 decades, there has been a dramatic increase in the number of advanced endoscopy training positions.⁹ In 2012, the American Society for Gastrointestinal Endoscopy established a match program to standardize the application process (www.asgematch.com).¹⁰ Since its inception, there have been approximately 100 applicants per year and 60 participating programs. In the 2018 match, there were 90 advanced endoscopy applicants for 69 positions. Each year, about 20% of graduating gastroenterology fellows apply for advanced endoscopy fellowship, and applicant match rates are approximately 60%.

The goal of advanced endoscopy fellowship is to teach trainees to safely and effectively perform high-risk endoscopic procedures.^1,11,12 Without ACGME oversight, no defined curricular requirements exist, and programs can be quite variable. Stronger programs offer close mentorship, conferences, comprehensive didactics, research support, and regular feedback. All programs participating in this year’s match offered training in both ERCP and EUS with most offering training in EMR, ablation, and deep enteroscopy.¹⁰ Many programs also offered training in endoluminal stenting and advanced closure techniques, such as suturing. More than half offered training in endoscopic submucosal dissection, peroral endoscopic myotomy, and bariatric endoscopy, but trainee hands-on time is usually limited, and competence is not guaranteed. A recent, large, multicenter, prospective study found that the median number of ERCPs and EUSs performed by trainees during advancing endoscopy training was 350 (range 125-500) and 300 (range 155-650), respectively.² Median number of ERCPs performed in patients with native papilla was 51 (range 32-79). Most ERCPs were performed for biliary indications, and most EUSs were performed for pancreaticobiliary indications. The study found that most advanced endoscopy trainees have limited exposure to interventional EUS procedures, ERCPs for pancreatic indications, and ERCPs requiring advanced cannulation techniques.

Competency assessment

Advanced endoscopy fellowship programs must ensure trainees have achieved technical and cognitive competence and are safe for independent practice. Methods to assess trainee competence in advanced procedures have changed significantly over the last several years.¹ Historically, endoscopic training was based on an apprenticeship model. Procedural volume and subjective assessments from trainers were used as surrogates for competence. Most current societal guidelines now recommend competency thresholds – a minimum number of supervised procedures that a trainee should complete before competency can be assessed – instead of absolute procedure volume requirements.^4,13,14 The ASGE recommends that at least 200 supervised independent ERCPs, including 80 independent sphincterotomies and 60 biliary stent placements, should be performed before assessing competence.⁴ Similarly, 225 supervised independent EUS cases are recommended before assessing competence. Importantly, these guidelines are not validated and do not account for the inherent variability in which different trainees acquire endoscopic skills.^15-18

Because of the limitations of volume-based assessments of competence, a greater emphasis has been placed on developing comprehensive, standardized competency assessments. With the ACGME’s adoption of the Next Accreditation System (NAS), a greater emphasis has been placed on competency-based medical education throughout the United States. The goal of the Next Accreditation System is to ensure that specific milestones are achieved by trainees and that trainee progress is clearly reported. Similarly, within advanced endoscopic training, it is now accepted that a minimum procedural volume is a necessary, but insufficient, marker of competence.¹ Therefore, recent work has focused on defining milestones, developing assessment tools with strong validity, establishing trainee learning curves, and providing trainees with continuous feedback that allows for targeted improvement. Although the data are limited, a few studies have assessed learning curves among trainees. A prospective study of 15 trainees from the Netherlands found that trainees acquire competence in ERCP skills at variable rates; specifically, trainees achieved competence in native papilla cannulation later than other ERCP skills.¹⁸ Similarly, a recent prospective multicenter study of advanced endoscopy trainees using a standardized assessment tool and cumulative sum analysis found significant variability in the learning curves for cognitive and technical aspects of ERCP.¹⁵

The EUS and ERCP Skills Assessment Tool (TEESAT) is a competence assessment tool for EUS and ERCP with strong validity evidence.^2,15,19-21 The tool assesses several individual technical and cognitive skills, in addition to a global assessment of competence, and should be used in a continuous fashion throughout fellowship training. A prospective, multicenter study using the TEESAT showed substantial variability in EUS and ERCP learning curves among trainees and demonstrated the feasibility of creating a national, centralized database that allows for continuous monitoring and reporting of individualized learning curves for EUS and ERCP among advanced endoscopy trainees.² Such a database is an important step in evolving with the ACGME/NAS reporting requirement and would allow for fellowship program directors and trainers to identify specific trainee deficiencies in order to deliver targeted remediation.

The impact of individualized feedback on trainee learning curves and EUS and ERCP quality indicators was addressed in a recently published prospective multicenter cohort study.²² In phase 1 of the study, 24 advanced endoscopy trainees from 20 programs were assessed using the TEESAT and given quarterly feedback. By the end of training, 92% and 74% of fellows had achieved overall technical competence in EUS and ERCP, respectively. In phase 2, trainees were assessed in their first year of independent practice to determine whether participation in competency-based fellowship programs results in high-quality care in independent practice. The study found that most trainees met performance thresholds for quality indicators in EUS (94% diagnostic rate of adequate samples and 84% diagnostic yield of malignancy in pancreatic masses) and ERCP (95% overall cannulation rate). While competence could not be confirmed for all trainees after fellowship completion, most met quality indicator thresholds for EUS and ERCP during the first year of independent practice. These data provide construct validity evidence for TEESAT and the data collection and reporting system that provides periodic feedback using learning curves and ultimately affirm the effectiveness of current training programs.
 

Establishing minimal standards for training programs

Although the ASGE offers rudimentary metrics to characterize fellowships through the match program, a more comprehensive evaluation of advanced endoscopy training programs would be of value to potential trainees. It is in this context that we offered the minimum ERCP (~250 cases for Grade 1 ERCP and ~300 cases for Grade 2 ERCP) and EUS (~225 cases) volumes that should serve as a basis for a more rigorous assessment of advanced endoscopy training programs. We also recently proposed structure, process, and outcomes measures that should be defined along with associated benchmarks (Table 1). These quality metrics could then be utilized to guide trainees in the selection of a program.

Conclusion

Advanced endoscopy training is a critical first step to ensuring endoscopists have the procedural and cognitive skills necessary to safely and effectively perform these high-risk procedures. As the portfolio of new procedures grows longer and more complex, it will become even more important for training programs to establish a standardized curriculum, adopt universal competency assessment tools, and provide continuous and targeted feedback to their trainees.

References

1. Wani S et al. Gastrointest Endosc. 2018;87:1371-82.

2. Wani S et al. Clin Gastroenterol Hepatol. 2017;15:1758-67 e11.

3. Patel SG et al. Am J Gastroenterol. 2015;110:956-62.

4. Committee ASoP et al. Gastrointest Endosc. 2017;85:273-81.

5. Cote GA et al. Gastrointest Endosc. 2011;74:65-73 e12.

6. Cotton PB et al. Gastrointest Endosc 2017;86:866-9.

7. Moffatt DC et al. Gastrointest Endosc. 2014;79:615-22.

8. Training and Education Committee of the American Gastroenterological Association. Gastroenterology 1988;94:1083-6.

9. Elta GH et al. Gastroenterology 2015;148:488-90.

10. www.asgematch.com. (Accessed June 21, 2018)

11. Jowell PS et al. Ann Intern Med 1996;125:983-9.

12. Eisen GM et al. Gastrointest Endosc 2002;55:780-3.

13. Polkowski M et al. Endoscopy 2012;44:190-206.

14. Committee AT et al. Gastrointest Endosc 2016;83:279-89.

15. Wani S et al. Gastrointest Endosc 2016;83:711-9 e11.

16. Northup PG et al. Gastroenterology 2013;144:677-80.

17. Eisen GM et al. Gastrointest Endosc 2001;53:846-8.

18. Ekkelenkamp VE et al. Endoscopy 2014;46:949-55.

19. Wani S et al. Clin Gastroenterol Hepatol 2015;13:1318-25 e2.

20. Wani S et al. Gastrointest Endosc 2013;77:558-65.
 

Dr. Duloy is a therapeutic gastroenterology fellow; Dr. Wani is an associate professor of medicine, University of Colorado Anschutz Medical Campus, Aurora, Colo.

Introduction

Comprehensive training in endoscopic retrograde cholangioscopy (ERCP) and endoscopic ultrasound (EUS) is difficult to achieve within the curriculum of a standard 3-year Accreditation Council for Graduate Medical Education (ACGME)–accredited gastroenterology fellowship. ERCP and EUS are technically challenging, operator-dependent procedures that require specialized cognitive, technical, and integrative skills.^1-4 A survey of physicians performing ERCP found that only 60% felt “very comfortable” performing the procedure after completion of a standard gastroenterology fellowship.⁵ Procedural volumes in ERCP and EUS tend to be low among general gastroenterology fellows; in a survey, only 9% and 4.5% of trainees in standard gastrointestinal fellowships had anticipated volumes of more than 200 ERCP and EUS procedures, respectively.⁶ The unique skills required to safely and effectively perform ERCP and EUS, along with the growing portfolio of therapeutic procedures such as endoscopic mucosal resection (EMR), endoluminal stent placement, deep enteroscopy, advanced closure techniques, bariatric endoscopy, therapeutic EUS, and submucosal endoscopy (including endoscopic submucosal dissection and peroral endoscopic myotomy), has led to the development of dedicated postgraduate advanced endoscopy training programs.^7-9

Status of advanced endoscopy training in the United States

Advanced endoscopy fellowships are typically year-long training programs completed at tertiary care centers. Over the last 2 decades, there has been a dramatic increase in the number of advanced endoscopy training positions.⁹ In 2012, the American Society for Gastrointestinal Endoscopy established a match program to standardize the application process (www.asgematch.com).¹⁰ Since its inception, there have been approximately 100 applicants per year and 60 participating programs. In the 2018 match, there were 90 advanced endoscopy applicants for 69 positions. Each year, about 20% of graduating gastroenterology fellows apply for advanced endoscopy fellowship, and applicant match rates are approximately 60%.

The goal of advanced endoscopy fellowship is to teach trainees to safely and effectively perform high-risk endoscopic procedures.^1,11,12 Without ACGME oversight, no defined curricular requirements exist, and programs can be quite variable. Stronger programs offer close mentorship, conferences, comprehensive didactics, research support, and regular feedback. All programs participating in this year’s match offered training in both ERCP and EUS with most offering training in EMR, ablation, and deep enteroscopy.¹⁰ Many programs also offered training in endoluminal stenting and advanced closure techniques, such as suturing. More than half offered training in endoscopic submucosal dissection, peroral endoscopic myotomy, and bariatric endoscopy, but trainee hands-on time is usually limited, and competence is not guaranteed. A recent, large, multicenter, prospective study found that the median number of ERCPs and EUSs performed by trainees during advancing endoscopy training was 350 (range 125-500) and 300 (range 155-650), respectively.² Median number of ERCPs performed in patients with native papilla was 51 (range 32-79). Most ERCPs were performed for biliary indications, and most EUSs were performed for pancreaticobiliary indications. The study found that most advanced endoscopy trainees have limited exposure to interventional EUS procedures, ERCPs for pancreatic indications, and ERCPs requiring advanced cannulation techniques.

Competency assessment

Advanced endoscopy fellowship programs must ensure trainees have achieved technical and cognitive competence and are safe for independent practice. Methods to assess trainee competence in advanced procedures have changed significantly over the last several years.¹ Historically, endoscopic training was based on an apprenticeship model. Procedural volume and subjective assessments from trainers were used as surrogates for competence. Most current societal guidelines now recommend competency thresholds – a minimum number of supervised procedures that a trainee should complete before competency can be assessed – instead of absolute procedure volume requirements.^4,13,14 The ASGE recommends that at least 200 supervised independent ERCPs, including 80 independent sphincterotomies and 60 biliary stent placements, should be performed before assessing competence.⁴ Similarly, 225 supervised independent EUS cases are recommended before assessing competence. Importantly, these guidelines are not validated and do not account for the inherent variability in which different trainees acquire endoscopic skills.^15-18

Because of the limitations of volume-based assessments of competence, a greater emphasis has been placed on developing comprehensive, standardized competency assessments. With the ACGME’s adoption of the Next Accreditation System (NAS), a greater emphasis has been placed on competency-based medical education throughout the United States. The goal of the Next Accreditation System is to ensure that specific milestones are achieved by trainees and that trainee progress is clearly reported. Similarly, within advanced endoscopic training, it is now accepted that a minimum procedural volume is a necessary, but insufficient, marker of competence.¹ Therefore, recent work has focused on defining milestones, developing assessment tools with strong validity, establishing trainee learning curves, and providing trainees with continuous feedback that allows for targeted improvement. Although the data are limited, a few studies have assessed learning curves among trainees. A prospective study of 15 trainees from the Netherlands found that trainees acquire competence in ERCP skills at variable rates; specifically, trainees achieved competence in native papilla cannulation later than other ERCP skills.¹⁸ Similarly, a recent prospective multicenter study of advanced endoscopy trainees using a standardized assessment tool and cumulative sum analysis found significant variability in the learning curves for cognitive and technical aspects of ERCP.¹⁵

The EUS and ERCP Skills Assessment Tool (TEESAT) is a competence assessment tool for EUS and ERCP with strong validity evidence.^2,15,19-21 The tool assesses several individual technical and cognitive skills, in addition to a global assessment of competence, and should be used in a continuous fashion throughout fellowship training. A prospective, multicenter study using the TEESAT showed substantial variability in EUS and ERCP learning curves among trainees and demonstrated the feasibility of creating a national, centralized database that allows for continuous monitoring and reporting of individualized learning curves for EUS and ERCP among advanced endoscopy trainees.² Such a database is an important step in evolving with the ACGME/NAS reporting requirement and would allow for fellowship program directors and trainers to identify specific trainee deficiencies in order to deliver targeted remediation.

The impact of individualized feedback on trainee learning curves and EUS and ERCP quality indicators was addressed in a recently published prospective multicenter cohort study.²² In phase 1 of the study, 24 advanced endoscopy trainees from 20 programs were assessed using the TEESAT and given quarterly feedback. By the end of training, 92% and 74% of fellows had achieved overall technical competence in EUS and ERCP, respectively. In phase 2, trainees were assessed in their first year of independent practice to determine whether participation in competency-based fellowship programs results in high-quality care in independent practice. The study found that most trainees met performance thresholds for quality indicators in EUS (94% diagnostic rate of adequate samples and 84% diagnostic yield of malignancy in pancreatic masses) and ERCP (95% overall cannulation rate). While competence could not be confirmed for all trainees after fellowship completion, most met quality indicator thresholds for EUS and ERCP during the first year of independent practice. These data provide construct validity evidence for TEESAT and the data collection and reporting system that provides periodic feedback using learning curves and ultimately affirm the effectiveness of current training programs.
 

Establishing minimal standards for training programs

Although the ASGE offers rudimentary metrics to characterize fellowships through the match program, a more comprehensive evaluation of advanced endoscopy training programs would be of value to potential trainees. It is in this context that we offered the minimum ERCP (~250 cases for Grade 1 ERCP and ~300 cases for Grade 2 ERCP) and EUS (~225 cases) volumes that should serve as a basis for a more rigorous assessment of advanced endoscopy training programs. We also recently proposed structure, process, and outcomes measures that should be defined along with associated benchmarks (Table 1). These quality metrics could then be utilized to guide trainees in the selection of a program.

Conclusion

Advanced endoscopy training is a critical first step to ensuring endoscopists have the procedural and cognitive skills necessary to safely and effectively perform these high-risk procedures. As the portfolio of new procedures grows longer and more complex, it will become even more important for training programs to establish a standardized curriculum, adopt universal competency assessment tools, and provide continuous and targeted feedback to their trainees.

References

1. Wani S et al. Gastrointest Endosc. 2018;87:1371-82.

2. Wani S et al. Clin Gastroenterol Hepatol. 2017;15:1758-67 e11.

3. Patel SG et al. Am J Gastroenterol. 2015;110:956-62.

4. Committee ASoP et al. Gastrointest Endosc. 2017;85:273-81.

5. Cote GA et al. Gastrointest Endosc. 2011;74:65-73 e12.

6. Cotton PB et al. Gastrointest Endosc 2017;86:866-9.

7. Moffatt DC et al. Gastrointest Endosc. 2014;79:615-22.

8. Training and Education Committee of the American Gastroenterological Association. Gastroenterology 1988;94:1083-6.

9. Elta GH et al. Gastroenterology 2015;148:488-90.

10. www.asgematch.com. (Accessed June 21, 2018)

11. Jowell PS et al. Ann Intern Med 1996;125:983-9.

12. Eisen GM et al. Gastrointest Endosc 2002;55:780-3.

13. Polkowski M et al. Endoscopy 2012;44:190-206.

14. Committee AT et al. Gastrointest Endosc 2016;83:279-89.

15. Wani S et al. Gastrointest Endosc 2016;83:711-9 e11.

16. Northup PG et al. Gastroenterology 2013;144:677-80.

17. Eisen GM et al. Gastrointest Endosc 2001;53:846-8.

18. Ekkelenkamp VE et al. Endoscopy 2014;46:949-55.

19. Wani S et al. Clin Gastroenterol Hepatol 2015;13:1318-25 e2.

20. Wani S et al. Gastrointest Endosc 2013;77:558-65.
 

Dr. Duloy is a therapeutic gastroenterology fellow; Dr. Wani is an associate professor of medicine, University of Colorado Anschutz Medical Campus, Aurora, Colo.

Introduction

Comprehensive training in endoscopic retrograde cholangioscopy (ERCP) and endoscopic ultrasound (EUS) is difficult to achieve within the curriculum of a standard 3-year Accreditation Council for Graduate Medical Education (ACGME)–accredited gastroenterology fellowship. ERCP and EUS are technically challenging, operator-dependent procedures that require specialized cognitive, technical, and integrative skills.^1-4 A survey of physicians performing ERCP found that only 60% felt “very comfortable” performing the procedure after completion of a standard gastroenterology fellowship.⁵ Procedural volumes in ERCP and EUS tend to be low among general gastroenterology fellows; in a survey, only 9% and 4.5% of trainees in standard gastrointestinal fellowships had anticipated volumes of more than 200 ERCP and EUS procedures, respectively.⁶ The unique skills required to safely and effectively perform ERCP and EUS, along with the growing portfolio of therapeutic procedures such as endoscopic mucosal resection (EMR), endoluminal stent placement, deep enteroscopy, advanced closure techniques, bariatric endoscopy, therapeutic EUS, and submucosal endoscopy (including endoscopic submucosal dissection and peroral endoscopic myotomy), has led to the development of dedicated postgraduate advanced endoscopy training programs.^7-9

Status of advanced endoscopy training in the United States

Advanced endoscopy fellowships are typically year-long training programs completed at tertiary care centers. Over the last 2 decades, there has been a dramatic increase in the number of advanced endoscopy training positions.⁹ In 2012, the American Society for Gastrointestinal Endoscopy established a match program to standardize the application process (www.asgematch.com).¹⁰ Since its inception, there have been approximately 100 applicants per year and 60 participating programs. In the 2018 match, there were 90 advanced endoscopy applicants for 69 positions. Each year, about 20% of graduating gastroenterology fellows apply for advanced endoscopy fellowship, and applicant match rates are approximately 60%.

The goal of advanced endoscopy fellowship is to teach trainees to safely and effectively perform high-risk endoscopic procedures.^1,11,12 Without ACGME oversight, no defined curricular requirements exist, and programs can be quite variable. Stronger programs offer close mentorship, conferences, comprehensive didactics, research support, and regular feedback. All programs participating in this year’s match offered training in both ERCP and EUS with most offering training in EMR, ablation, and deep enteroscopy.¹⁰ Many programs also offered training in endoluminal stenting and advanced closure techniques, such as suturing. More than half offered training in endoscopic submucosal dissection, peroral endoscopic myotomy, and bariatric endoscopy, but trainee hands-on time is usually limited, and competence is not guaranteed. A recent, large, multicenter, prospective study found that the median number of ERCPs and EUSs performed by trainees during advancing endoscopy training was 350 (range 125-500) and 300 (range 155-650), respectively.² Median number of ERCPs performed in patients with native papilla was 51 (range 32-79). Most ERCPs were performed for biliary indications, and most EUSs were performed for pancreaticobiliary indications. The study found that most advanced endoscopy trainees have limited exposure to interventional EUS procedures, ERCPs for pancreatic indications, and ERCPs requiring advanced cannulation techniques.

Competency assessment

Advanced endoscopy fellowship programs must ensure trainees have achieved technical and cognitive competence and are safe for independent practice. Methods to assess trainee competence in advanced procedures have changed significantly over the last several years.¹ Historically, endoscopic training was based on an apprenticeship model. Procedural volume and subjective assessments from trainers were used as surrogates for competence. Most current societal guidelines now recommend competency thresholds – a minimum number of supervised procedures that a trainee should complete before competency can be assessed – instead of absolute procedure volume requirements.^4,13,14 The ASGE recommends that at least 200 supervised independent ERCPs, including 80 independent sphincterotomies and 60 biliary stent placements, should be performed before assessing competence.⁴ Similarly, 225 supervised independent EUS cases are recommended before assessing competence. Importantly, these guidelines are not validated and do not account for the inherent variability in which different trainees acquire endoscopic skills.^15-18

Because of the limitations of volume-based assessments of competence, a greater emphasis has been placed on developing comprehensive, standardized competency assessments. With the ACGME’s adoption of the Next Accreditation System (NAS), a greater emphasis has been placed on competency-based medical education throughout the United States. The goal of the Next Accreditation System is to ensure that specific milestones are achieved by trainees and that trainee progress is clearly reported. Similarly, within advanced endoscopic training, it is now accepted that a minimum procedural volume is a necessary, but insufficient, marker of competence.¹ Therefore, recent work has focused on defining milestones, developing assessment tools with strong validity, establishing trainee learning curves, and providing trainees with continuous feedback that allows for targeted improvement. Although the data are limited, a few studies have assessed learning curves among trainees. A prospective study of 15 trainees from the Netherlands found that trainees acquire competence in ERCP skills at variable rates; specifically, trainees achieved competence in native papilla cannulation later than other ERCP skills.¹⁸ Similarly, a recent prospective multicenter study of advanced endoscopy trainees using a standardized assessment tool and cumulative sum analysis found significant variability in the learning curves for cognitive and technical aspects of ERCP.¹⁵

The EUS and ERCP Skills Assessment Tool (TEESAT) is a competence assessment tool for EUS and ERCP with strong validity evidence.^2,15,19-21 The tool assesses several individual technical and cognitive skills, in addition to a global assessment of competence, and should be used in a continuous fashion throughout fellowship training. A prospective, multicenter study using the TEESAT showed substantial variability in EUS and ERCP learning curves among trainees and demonstrated the feasibility of creating a national, centralized database that allows for continuous monitoring and reporting of individualized learning curves for EUS and ERCP among advanced endoscopy trainees.² Such a database is an important step in evolving with the ACGME/NAS reporting requirement and would allow for fellowship program directors and trainers to identify specific trainee deficiencies in order to deliver targeted remediation.

The impact of individualized feedback on trainee learning curves and EUS and ERCP quality indicators was addressed in a recently published prospective multicenter cohort study.²² In phase 1 of the study, 24 advanced endoscopy trainees from 20 programs were assessed using the TEESAT and given quarterly feedback. By the end of training, 92% and 74% of fellows had achieved overall technical competence in EUS and ERCP, respectively. In phase 2, trainees were assessed in their first year of independent practice to determine whether participation in competency-based fellowship programs results in high-quality care in independent practice. The study found that most trainees met performance thresholds for quality indicators in EUS (94% diagnostic rate of adequate samples and 84% diagnostic yield of malignancy in pancreatic masses) and ERCP (95% overall cannulation rate). While competence could not be confirmed for all trainees after fellowship completion, most met quality indicator thresholds for EUS and ERCP during the first year of independent practice. These data provide construct validity evidence for TEESAT and the data collection and reporting system that provides periodic feedback using learning curves and ultimately affirm the effectiveness of current training programs.
 

Establishing minimal standards for training programs

Although the ASGE offers rudimentary metrics to characterize fellowships through the match program, a more comprehensive evaluation of advanced endoscopy training programs would be of value to potential trainees. It is in this context that we offered the minimum ERCP (~250 cases for Grade 1 ERCP and ~300 cases for Grade 2 ERCP) and EUS (~225 cases) volumes that should serve as a basis for a more rigorous assessment of advanced endoscopy training programs. We also recently proposed structure, process, and outcomes measures that should be defined along with associated benchmarks (Table 1). These quality metrics could then be utilized to guide trainees in the selection of a program.

Conclusion

Advanced endoscopy training is a critical first step to ensuring endoscopists have the procedural and cognitive skills necessary to safely and effectively perform these high-risk procedures. As the portfolio of new procedures grows longer and more complex, it will become even more important for training programs to establish a standardized curriculum, adopt universal competency assessment tools, and provide continuous and targeted feedback to their trainees.

References

1. Wani S et al. Gastrointest Endosc. 2018;87:1371-82.

2. Wani S et al. Clin Gastroenterol Hepatol. 2017;15:1758-67 e11.

3. Patel SG et al. Am J Gastroenterol. 2015;110:956-62.

4. Committee ASoP et al. Gastrointest Endosc. 2017;85:273-81.

5. Cote GA et al. Gastrointest Endosc. 2011;74:65-73 e12.

6. Cotton PB et al. Gastrointest Endosc 2017;86:866-9.

7. Moffatt DC et al. Gastrointest Endosc. 2014;79:615-22.

8. Training and Education Committee of the American Gastroenterological Association. Gastroenterology 1988;94:1083-6.

9. Elta GH et al. Gastroenterology 2015;148:488-90.

10. www.asgematch.com. (Accessed June 21, 2018)

11. Jowell PS et al. Ann Intern Med 1996;125:983-9.

12. Eisen GM et al. Gastrointest Endosc 2002;55:780-3.

13. Polkowski M et al. Endoscopy 2012;44:190-206.

14. Committee AT et al. Gastrointest Endosc 2016;83:279-89.

15. Wani S et al. Gastrointest Endosc 2016;83:711-9 e11.

16. Northup PG et al. Gastroenterology 2013;144:677-80.

17. Eisen GM et al. Gastrointest Endosc 2001;53:846-8.

18. Ekkelenkamp VE et al. Endoscopy 2014;46:949-55.

19. Wani S et al. Clin Gastroenterol Hepatol 2015;13:1318-25 e2.

20. Wani S et al. Gastrointest Endosc 2013;77:558-65.
 

Dr. Duloy is a therapeutic gastroenterology fellow; Dr. Wani is an associate professor of medicine, University of Colorado Anschutz Medical Campus, Aurora, Colo.

Financial planning for families can involve multiple investment goals. The big ones usually are investing for retirement and for your children’s college expenses. With any investment strategy, once you have identified an investment goal, you will want to utilize the right investment account to achieve that goal. If investing for future college expenses is your goal, then one of the investment accounts you will want to utilize is called a 529 plan.

What is a 529 plan?

A 529 plan is a tax-favored account authorized by Section 529 of the Internal Revenue Code and sponsored by a state or educational institution. These plans have specific tax-saving features to them, compared with other taxable accounts, which are listed below. To begin with, there are two types of 529 plans: prepaid tuition plans and education savings plans. Every state has at least one type of 529 plan. Additionally, some private colleges sponsor a prepaid tuition plan.

Prepaid tuition plan

The first type of 529 account is a prepaid tuition plan. These let an account owner purchase college credits (or units) for participating colleges or universities at today’s prices to be used for the student’s future tuition charges. The states that sponsor prepaid plans do so primarily for the benefit of their in-state public colleges and universities. Things to know about the prepaid plans: States may or may not guarantee that the prepaid units keep up with increases in tuition charges. The plan also may have a state residency requirement. If the student decides not to attend one of the eligible schools, the equivalent payout may be less than had the student attended one of the participating institutions. There are no federal guarantees on the state prepaid plans and they are not available for private elementary and high school programs.

Education savings plan

The second type of 529 account is an education savings plan, an investment account into which you can invest your after-tax dollars. The intent with these accounts is to grow the balance for use at a future date. These are tax-deferred accounts, which means each year the interest, dividends, and capital gains created within the account do not show up on your tax return. If the funds are used for a “qualified” higher-education expense, then gains on the account are not taxed upon withdrawal.

As with most investments, the longer your money is invested, the more time it has to grow via accumulated interest, dividends, and appreciation. The larger the growth, the larger the tax benefits. This offers a tremendous advantage for a high-income and high-tax bracket household to invest for future goals (such as private school tuition or college expenses). By contrast, if you had invested in a fully taxable account, you would be subject to taxes each year on the interest, dividends, and capital gain distributions. Also, with taxable accounts, your investments would be subject to capital gains tax on the growth when they are sold to pay for those future expenses.

An account owner may choose among a range of investment options that the 529 plan provides. These are typically individual mutual funds or preformed mutual fund portfolios. The portfolios may have a fixed allocation percentage that stays the same over time or come “age-weighted,” meaning the investment allocation becomes more conservative the closer the student gets to college age when withdrawals would occur. This is a similar approach to the “target retirement date” offerings one sees in retirement accounts.

If one is using the 529 account for the student’s elementary or high school years, the investment time frame may be shorter and necessitate a more conservative approach, as the time for withdrawals would be nearer than the college years. As with most investments, the account can lose value based on investment performance.
 

Owner versus beneficiary

There are two parties to any 529 plan account: The account owner, who has control over the account and can name the beneficiary to the account, and the beneficiary (the student). The account owner can change beneficiaries on the account and can even name themselves as the beneficiary. One can name anyone as the beneficiary (e.g., child, friend, relative, yourself). You can be proactive by creating an account and naming yourself the beneficiary now, before switching to your child in the future. The account owner can live in one state with the beneficiary in another and invest in the 529 from a third state, and the student may eventually go to an educational institution in a fourth state. The 529 education savings account is not limited to any specific college, as a prepaid plan may be.

Withdrawals from 529s

If a 529 account withdrawal is for qualified higher education expenses or tuition for elementary or secondary schools, earnings are not subject to federal income tax or, in many cases, state income tax. Qualified withdrawals need to take place in the same tax year as the qualified expense.

Withdrawals not used for qualified higher education expenses in that year are considered “nonqualified” and would be subject to tax and 10% penalty on the earnings. State and local taxes may apply as well.

You can use the proceeds from the account free of taxes for the following qualified higher-education expenses:

• Tuition and school fees for both full and part time students at an eligible college, university, trade, or vocational institution.
• Room and board if the student is enrolled at more than half-time status. The amount up to the school’s room and board charges are eligible if paid directly to the school or to a landlord if living in nonschool housing. If actual charges to the landlord exceed the schools’ charges, then the amount above the school’s charges would be considered an excess withdrawal.
• Required books, supplies, and equipment for the academic program. Computer and technology equipment, printers, and required software, and such related services as Internet access also are qualified expenses.
• Private elementary or secondary school tuition up to $10,000 annually also is a qualified expense for 529 withdrawals.

Health insurance for the student and transportation-related costs to and from the school are not qualified expenses.
 

Contributions and fees

Like all investments, the fees associated with a 529 account need to be considered, as excess fees lower the investment returns. Prepaid tuition plans may charge initial application, transaction, and ongoing administrative fees. Investment 529 accounts may also have administrative costs such as program management fees, per-transaction fees, and the underlying investment expense ratios. Some states have broker-sold plans as well as direct-sold plans. Broker-sold plans can be purchased only through a broker and have the additional expenses associated with that either in the form of a load (sales charge) or higher expense ratio.

Contributions to a 529 plan can only be made in cash. If you currently have other investments, they need to be liquidated first (with the associated tax consequence) and then the proceeds invested into the 529 plan. Establishing the account and ongoing contributions are subject to gift tax limits ($15,000 for 2019). A married couple may make a “joint gift” to the account to double the limit. The 529 plans also allow the owner to front-load the account in 1 year with up to 5 years’ worth of gift limit contributions all at once. This lump sum is treated for tax reasons as a pro-rata 5 consecutive years of contributions all at once. Any additional gifts to that beneficiary during that year and the remaining four would be subject to gift tax issues if it means the annual gift limits were exceeded. Contributions are considered a “completed gift” for gift- and estate-tax purposes even though the account owner retains an element of control. The up-front 5-year gift election is available only on 529 accounts and is a great way for parents and grandparents (hint-hint) to reduce their estates and get a significant initial balance into the account. This can come in handy for those who may have procrastinated working toward this investment goal and need to catch up.

If the beneficiary does not need all or some of the funds for qualified higher education expenses, the account owner has options: One can change beneficiary to another relative who may need the funds or keep the account going and eventually add a grandchild as a beneficiary. Graduate school expenses also are eligible. A student can have multiple 529 accounts set up in their name.
 

Additional tax considerations

Education Tax Credits like the American Opportunity Tax Credit and the Lifetime Learning Credit have income phase-outs that you may or may not be eligible for based on your income. Education expenses used to qualify for the tax-free withdrawal from a 529 plan cannot be used to claim these tax credits. Several states offer state income tax deductions for contributions to a 529 plan but may have eligibility limited to the in-state plan only. It is wise to look to your own state’s plan first to see if that is the case and consider that as a factor when you choose a plan right for you. Refer to your tax professional for your eligibility.

In conclusion, 529 savings plans represent a tax-free way to grow your investments for future education expenses down the road, even if you don’t have a child yet. Speak to your financial adviser to learn about plans and contribution schedules that work with your current and future investing goals.
 

Good sources for further information include:

• www.savingforcollege.com.
• www.irs.gov/forms-pubs/about-publication-970.
• www.finra.org/investors/saving-college.

Mr. Clancy is director of financial planning, Drexel University College of Medicine.

Financial planning for families can involve multiple investment goals. The big ones usually are investing for retirement and for your children’s college expenses. With any investment strategy, once you have identified an investment goal, you will want to utilize the right investment account to achieve that goal. If investing for future college expenses is your goal, then one of the investment accounts you will want to utilize is called a 529 plan.

What is a 529 plan?

A 529 plan is a tax-favored account authorized by Section 529 of the Internal Revenue Code and sponsored by a state or educational institution. These plans have specific tax-saving features to them, compared with other taxable accounts, which are listed below. To begin with, there are two types of 529 plans: prepaid tuition plans and education savings plans. Every state has at least one type of 529 plan. Additionally, some private colleges sponsor a prepaid tuition plan.

Prepaid tuition plan

The first type of 529 account is a prepaid tuition plan. These let an account owner purchase college credits (or units) for participating colleges or universities at today’s prices to be used for the student’s future tuition charges. The states that sponsor prepaid plans do so primarily for the benefit of their in-state public colleges and universities. Things to know about the prepaid plans: States may or may not guarantee that the prepaid units keep up with increases in tuition charges. The plan also may have a state residency requirement. If the student decides not to attend one of the eligible schools, the equivalent payout may be less than had the student attended one of the participating institutions. There are no federal guarantees on the state prepaid plans and they are not available for private elementary and high school programs.

Education savings plan

The second type of 529 account is an education savings plan, an investment account into which you can invest your after-tax dollars. The intent with these accounts is to grow the balance for use at a future date. These are tax-deferred accounts, which means each year the interest, dividends, and capital gains created within the account do not show up on your tax return. If the funds are used for a “qualified” higher-education expense, then gains on the account are not taxed upon withdrawal.

As with most investments, the longer your money is invested, the more time it has to grow via accumulated interest, dividends, and appreciation. The larger the growth, the larger the tax benefits. This offers a tremendous advantage for a high-income and high-tax bracket household to invest for future goals (such as private school tuition or college expenses). By contrast, if you had invested in a fully taxable account, you would be subject to taxes each year on the interest, dividends, and capital gain distributions. Also, with taxable accounts, your investments would be subject to capital gains tax on the growth when they are sold to pay for those future expenses.

An account owner may choose among a range of investment options that the 529 plan provides. These are typically individual mutual funds or preformed mutual fund portfolios. The portfolios may have a fixed allocation percentage that stays the same over time or come “age-weighted,” meaning the investment allocation becomes more conservative the closer the student gets to college age when withdrawals would occur. This is a similar approach to the “target retirement date” offerings one sees in retirement accounts.

If one is using the 529 account for the student’s elementary or high school years, the investment time frame may be shorter and necessitate a more conservative approach, as the time for withdrawals would be nearer than the college years. As with most investments, the account can lose value based on investment performance.
 

Owner versus beneficiary

There are two parties to any 529 plan account: The account owner, who has control over the account and can name the beneficiary to the account, and the beneficiary (the student). The account owner can change beneficiaries on the account and can even name themselves as the beneficiary. One can name anyone as the beneficiary (e.g., child, friend, relative, yourself). You can be proactive by creating an account and naming yourself the beneficiary now, before switching to your child in the future. The account owner can live in one state with the beneficiary in another and invest in the 529 from a third state, and the student may eventually go to an educational institution in a fourth state. The 529 education savings account is not limited to any specific college, as a prepaid plan may be.

Withdrawals from 529s

If a 529 account withdrawal is for qualified higher education expenses or tuition for elementary or secondary schools, earnings are not subject to federal income tax or, in many cases, state income tax. Qualified withdrawals need to take place in the same tax year as the qualified expense.

Withdrawals not used for qualified higher education expenses in that year are considered “nonqualified” and would be subject to tax and 10% penalty on the earnings. State and local taxes may apply as well.

You can use the proceeds from the account free of taxes for the following qualified higher-education expenses:

• Tuition and school fees for both full and part time students at an eligible college, university, trade, or vocational institution.
• Room and board if the student is enrolled at more than half-time status. The amount up to the school’s room and board charges are eligible if paid directly to the school or to a landlord if living in nonschool housing. If actual charges to the landlord exceed the schools’ charges, then the amount above the school’s charges would be considered an excess withdrawal.
• Required books, supplies, and equipment for the academic program. Computer and technology equipment, printers, and required software, and such related services as Internet access also are qualified expenses.
• Private elementary or secondary school tuition up to $10,000 annually also is a qualified expense for 529 withdrawals.

Health insurance for the student and transportation-related costs to and from the school are not qualified expenses.
 

Contributions and fees

Like all investments, the fees associated with a 529 account need to be considered, as excess fees lower the investment returns. Prepaid tuition plans may charge initial application, transaction, and ongoing administrative fees. Investment 529 accounts may also have administrative costs such as program management fees, per-transaction fees, and the underlying investment expense ratios. Some states have broker-sold plans as well as direct-sold plans. Broker-sold plans can be purchased only through a broker and have the additional expenses associated with that either in the form of a load (sales charge) or higher expense ratio.

Contributions to a 529 plan can only be made in cash. If you currently have other investments, they need to be liquidated first (with the associated tax consequence) and then the proceeds invested into the 529 plan. Establishing the account and ongoing contributions are subject to gift tax limits ($15,000 for 2019). A married couple may make a “joint gift” to the account to double the limit. The 529 plans also allow the owner to front-load the account in 1 year with up to 5 years’ worth of gift limit contributions all at once. This lump sum is treated for tax reasons as a pro-rata 5 consecutive years of contributions all at once. Any additional gifts to that beneficiary during that year and the remaining four would be subject to gift tax issues if it means the annual gift limits were exceeded. Contributions are considered a “completed gift” for gift- and estate-tax purposes even though the account owner retains an element of control. The up-front 5-year gift election is available only on 529 accounts and is a great way for parents and grandparents (hint-hint) to reduce their estates and get a significant initial balance into the account. This can come in handy for those who may have procrastinated working toward this investment goal and need to catch up.

If the beneficiary does not need all or some of the funds for qualified higher education expenses, the account owner has options: One can change beneficiary to another relative who may need the funds or keep the account going and eventually add a grandchild as a beneficiary. Graduate school expenses also are eligible. A student can have multiple 529 accounts set up in their name.
 

Additional tax considerations

Education Tax Credits like the American Opportunity Tax Credit and the Lifetime Learning Credit have income phase-outs that you may or may not be eligible for based on your income. Education expenses used to qualify for the tax-free withdrawal from a 529 plan cannot be used to claim these tax credits. Several states offer state income tax deductions for contributions to a 529 plan but may have eligibility limited to the in-state plan only. It is wise to look to your own state’s plan first to see if that is the case and consider that as a factor when you choose a plan right for you. Refer to your tax professional for your eligibility.

In conclusion, 529 savings plans represent a tax-free way to grow your investments for future education expenses down the road, even if you don’t have a child yet. Speak to your financial adviser to learn about plans and contribution schedules that work with your current and future investing goals.
 

Good sources for further information include:

• www.savingforcollege.com.
• www.irs.gov/forms-pubs/about-publication-970.
• www.finra.org/investors/saving-college.

Mr. Clancy is director of financial planning, Drexel University College of Medicine.

Financial planning for families can involve multiple investment goals. The big ones usually are investing for retirement and for your children’s college expenses. With any investment strategy, once you have identified an investment goal, you will want to utilize the right investment account to achieve that goal. If investing for future college expenses is your goal, then one of the investment accounts you will want to utilize is called a 529 plan.

What is a 529 plan?

A 529 plan is a tax-favored account authorized by Section 529 of the Internal Revenue Code and sponsored by a state or educational institution. These plans have specific tax-saving features to them, compared with other taxable accounts, which are listed below. To begin with, there are two types of 529 plans: prepaid tuition plans and education savings plans. Every state has at least one type of 529 plan. Additionally, some private colleges sponsor a prepaid tuition plan.

Prepaid tuition plan

The first type of 529 account is a prepaid tuition plan. These let an account owner purchase college credits (or units) for participating colleges or universities at today’s prices to be used for the student’s future tuition charges. The states that sponsor prepaid plans do so primarily for the benefit of their in-state public colleges and universities. Things to know about the prepaid plans: States may or may not guarantee that the prepaid units keep up with increases in tuition charges. The plan also may have a state residency requirement. If the student decides not to attend one of the eligible schools, the equivalent payout may be less than had the student attended one of the participating institutions. There are no federal guarantees on the state prepaid plans and they are not available for private elementary and high school programs.

Education savings plan

The second type of 529 account is an education savings plan, an investment account into which you can invest your after-tax dollars. The intent with these accounts is to grow the balance for use at a future date. These are tax-deferred accounts, which means each year the interest, dividends, and capital gains created within the account do not show up on your tax return. If the funds are used for a “qualified” higher-education expense, then gains on the account are not taxed upon withdrawal.

As with most investments, the longer your money is invested, the more time it has to grow via accumulated interest, dividends, and appreciation. The larger the growth, the larger the tax benefits. This offers a tremendous advantage for a high-income and high-tax bracket household to invest for future goals (such as private school tuition or college expenses). By contrast, if you had invested in a fully taxable account, you would be subject to taxes each year on the interest, dividends, and capital gain distributions. Also, with taxable accounts, your investments would be subject to capital gains tax on the growth when they are sold to pay for those future expenses.

An account owner may choose among a range of investment options that the 529 plan provides. These are typically individual mutual funds or preformed mutual fund portfolios. The portfolios may have a fixed allocation percentage that stays the same over time or come “age-weighted,” meaning the investment allocation becomes more conservative the closer the student gets to college age when withdrawals would occur. This is a similar approach to the “target retirement date” offerings one sees in retirement accounts.

If one is using the 529 account for the student’s elementary or high school years, the investment time frame may be shorter and necessitate a more conservative approach, as the time for withdrawals would be nearer than the college years. As with most investments, the account can lose value based on investment performance.
 

Owner versus beneficiary

There are two parties to any 529 plan account: The account owner, who has control over the account and can name the beneficiary to the account, and the beneficiary (the student). The account owner can change beneficiaries on the account and can even name themselves as the beneficiary. One can name anyone as the beneficiary (e.g., child, friend, relative, yourself). You can be proactive by creating an account and naming yourself the beneficiary now, before switching to your child in the future. The account owner can live in one state with the beneficiary in another and invest in the 529 from a third state, and the student may eventually go to an educational institution in a fourth state. The 529 education savings account is not limited to any specific college, as a prepaid plan may be.

Withdrawals from 529s

If a 529 account withdrawal is for qualified higher education expenses or tuition for elementary or secondary schools, earnings are not subject to federal income tax or, in many cases, state income tax. Qualified withdrawals need to take place in the same tax year as the qualified expense.

Withdrawals not used for qualified higher education expenses in that year are considered “nonqualified” and would be subject to tax and 10% penalty on the earnings. State and local taxes may apply as well.

You can use the proceeds from the account free of taxes for the following qualified higher-education expenses:

• Tuition and school fees for both full and part time students at an eligible college, university, trade, or vocational institution.
• Room and board if the student is enrolled at more than half-time status. The amount up to the school’s room and board charges are eligible if paid directly to the school or to a landlord if living in nonschool housing. If actual charges to the landlord exceed the schools’ charges, then the amount above the school’s charges would be considered an excess withdrawal.
• Required books, supplies, and equipment for the academic program. Computer and technology equipment, printers, and required software, and such related services as Internet access also are qualified expenses.
• Private elementary or secondary school tuition up to $10,000 annually also is a qualified expense for 529 withdrawals.

Health insurance for the student and transportation-related costs to and from the school are not qualified expenses.
 

Contributions and fees

Like all investments, the fees associated with a 529 account need to be considered, as excess fees lower the investment returns. Prepaid tuition plans may charge initial application, transaction, and ongoing administrative fees. Investment 529 accounts may also have administrative costs such as program management fees, per-transaction fees, and the underlying investment expense ratios. Some states have broker-sold plans as well as direct-sold plans. Broker-sold plans can be purchased only through a broker and have the additional expenses associated with that either in the form of a load (sales charge) or higher expense ratio.

Contributions to a 529 plan can only be made in cash. If you currently have other investments, they need to be liquidated first (with the associated tax consequence) and then the proceeds invested into the 529 plan. Establishing the account and ongoing contributions are subject to gift tax limits ($15,000 for 2019). A married couple may make a “joint gift” to the account to double the limit. The 529 plans also allow the owner to front-load the account in 1 year with up to 5 years’ worth of gift limit contributions all at once. This lump sum is treated for tax reasons as a pro-rata 5 consecutive years of contributions all at once. Any additional gifts to that beneficiary during that year and the remaining four would be subject to gift tax issues if it means the annual gift limits were exceeded. Contributions are considered a “completed gift” for gift- and estate-tax purposes even though the account owner retains an element of control. The up-front 5-year gift election is available only on 529 accounts and is a great way for parents and grandparents (hint-hint) to reduce their estates and get a significant initial balance into the account. This can come in handy for those who may have procrastinated working toward this investment goal and need to catch up.

If the beneficiary does not need all or some of the funds for qualified higher education expenses, the account owner has options: One can change beneficiary to another relative who may need the funds or keep the account going and eventually add a grandchild as a beneficiary. Graduate school expenses also are eligible. A student can have multiple 529 accounts set up in their name.
 

Additional tax considerations

Education Tax Credits like the American Opportunity Tax Credit and the Lifetime Learning Credit have income phase-outs that you may or may not be eligible for based on your income. Education expenses used to qualify for the tax-free withdrawal from a 529 plan cannot be used to claim these tax credits. Several states offer state income tax deductions for contributions to a 529 plan but may have eligibility limited to the in-state plan only. It is wise to look to your own state’s plan first to see if that is the case and consider that as a factor when you choose a plan right for you. Refer to your tax professional for your eligibility.

In conclusion, 529 savings plans represent a tax-free way to grow your investments for future education expenses down the road, even if you don’t have a child yet. Speak to your financial adviser to learn about plans and contribution schedules that work with your current and future investing goals.
 

Good sources for further information include:

• www.savingforcollege.com.
• www.irs.gov/forms-pubs/about-publication-970.
• www.finra.org/investors/saving-college.

Mr. Clancy is director of financial planning, Drexel University College of Medicine.

Dear Colleagues,

The November issue of The New Gastroenterologist is packed with some great articles! First, this issue’s In Focus article addresses the increasingly important topic of endoscopic management of obesity. In the article, the authors, Pichamol Jirapinyo and Christopher Thompson (Brigham and Women’s Hospital), provide an outstanding overview of the approved and up-and-coming endoscopic therapies that can be used to help treat the obesity epidemic. This is an area that we will inevitably see more of in our practices.

A new feature in this issue of The New Gastroenterologist is a column focused on early career gastroenterologists who are going into private practice, which was curated in conjunction with the Digestive Health Physicians Association. This month’s article by Fred Rosenberg (North Shore Endoscopy Center) provides an overview of private practice gastroenterology models. I look forward to making this column a recurring feature of future issues.

Additionally, using their wealth of experience, former CGH editor in chief Hashem El-Serag and current CGH editor in chief Fasiha Kanwal (Baylor) provide an enlightening piece on how to address reviewer criticism, which will no doubt be very helpful for those of us looking to publish. There is also a helpful article about grant writing tips authored by two successfully funded early career basic scientists, Arthur Beyder (Mayo) and Christina Twyman-Saint Victor (University of Pennsylvania).

For those considering pursuing extra training in IBD either during or after GI fellowship, Siddharth Singh (UCSD) goes through the different advanced training options that are now available in IBD. And finally, as many are laying down roots in new places, buying a house will almost inevitably be on the horizon. To help guide you through the mortgage preapproval process, Rob Wishnick (Guaranteed Rate) provides some useful insights from his many years of experience in the home loan industry.

Please check out “In Case You Missed It” to see other articles from the last quarter in AGA publications that may be of interest to you. And, if you have any ideas or want to contribute to The New Gastroenterologist, please contact me at [email protected] or the managing editor, Ryan Farrell, at [email protected].

Sincerely,

Bryson W. Katona, MD, PhD
Editor in Chief

Dr. Katona is an assistant professor of medicine in the division of gastroenterology at the University of Pennsylvania, Philadelphia.

Dear Colleagues,

The November issue of The New Gastroenterologist is packed with some great articles! First, this issue’s In Focus article addresses the increasingly important topic of endoscopic management of obesity. In the article, the authors, Pichamol Jirapinyo and Christopher Thompson (Brigham and Women’s Hospital), provide an outstanding overview of the approved and up-and-coming endoscopic therapies that can be used to help treat the obesity epidemic. This is an area that we will inevitably see more of in our practices.

A new feature in this issue of The New Gastroenterologist is a column focused on early career gastroenterologists who are going into private practice, which was curated in conjunction with the Digestive Health Physicians Association. This month’s article by Fred Rosenberg (North Shore Endoscopy Center) provides an overview of private practice gastroenterology models. I look forward to making this column a recurring feature of future issues.

Additionally, using their wealth of experience, former CGH editor in chief Hashem El-Serag and current CGH editor in chief Fasiha Kanwal (Baylor) provide an enlightening piece on how to address reviewer criticism, which will no doubt be very helpful for those of us looking to publish. There is also a helpful article about grant writing tips authored by two successfully funded early career basic scientists, Arthur Beyder (Mayo) and Christina Twyman-Saint Victor (University of Pennsylvania).

For those considering pursuing extra training in IBD either during or after GI fellowship, Siddharth Singh (UCSD) goes through the different advanced training options that are now available in IBD. And finally, as many are laying down roots in new places, buying a house will almost inevitably be on the horizon. To help guide you through the mortgage preapproval process, Rob Wishnick (Guaranteed Rate) provides some useful insights from his many years of experience in the home loan industry.

Please check out “In Case You Missed It” to see other articles from the last quarter in AGA publications that may be of interest to you. And, if you have any ideas or want to contribute to The New Gastroenterologist, please contact me at [email protected] or the managing editor, Ryan Farrell, at [email protected].

Sincerely,

Bryson W. Katona, MD, PhD
Editor in Chief

Dr. Katona is an assistant professor of medicine in the division of gastroenterology at the University of Pennsylvania, Philadelphia.

Dear Colleagues,

The November issue of The New Gastroenterologist is packed with some great articles! First, this issue’s In Focus article addresses the increasingly important topic of endoscopic management of obesity. In the article, the authors, Pichamol Jirapinyo and Christopher Thompson (Brigham and Women’s Hospital), provide an outstanding overview of the approved and up-and-coming endoscopic therapies that can be used to help treat the obesity epidemic. This is an area that we will inevitably see more of in our practices.

A new feature in this issue of The New Gastroenterologist is a column focused on early career gastroenterologists who are going into private practice, which was curated in conjunction with the Digestive Health Physicians Association. This month’s article by Fred Rosenberg (North Shore Endoscopy Center) provides an overview of private practice gastroenterology models. I look forward to making this column a recurring feature of future issues.

Additionally, using their wealth of experience, former CGH editor in chief Hashem El-Serag and current CGH editor in chief Fasiha Kanwal (Baylor) provide an enlightening piece on how to address reviewer criticism, which will no doubt be very helpful for those of us looking to publish. There is also a helpful article about grant writing tips authored by two successfully funded early career basic scientists, Arthur Beyder (Mayo) and Christina Twyman-Saint Victor (University of Pennsylvania).

For those considering pursuing extra training in IBD either during or after GI fellowship, Siddharth Singh (UCSD) goes through the different advanced training options that are now available in IBD. And finally, as many are laying down roots in new places, buying a house will almost inevitably be on the horizon. To help guide you through the mortgage preapproval process, Rob Wishnick (Guaranteed Rate) provides some useful insights from his many years of experience in the home loan industry.

Please check out “In Case You Missed It” to see other articles from the last quarter in AGA publications that may be of interest to you. And, if you have any ideas or want to contribute to The New Gastroenterologist, please contact me at [email protected] or the managing editor, Ryan Farrell, at [email protected].

Sincerely,

Bryson W. Katona, MD, PhD
Editor in Chief

Dr. Katona is an assistant professor of medicine in the division of gastroenterology at the University of Pennsylvania, Philadelphia.

Editor's Note

Gastroenterologists are becoming increasingly involved in the management of obesity. While prior therapy for obesity was mainly based on lifestyle changes, medication, or surgery, the new and exciting field of endoscopic bariatric and metabolic therapies has recently garnered incredible attention and momentum.

In this quarter’s In Focus article, brought to you by The New Gastroenterologist, Pichamol Jirapinyo and Christopher Thompson (Brigham and Women’s Hospital) provide an outstanding overview of the gastric and small bowel endoscopic interventions that are either already approved for use in obesity or currently being studied. This field is moving incredibly fast, and knowledge and understanding of these endoscopic therapies for obesity will undoubtedly be important for our field.

Bryson W. Katona, MD, PhD
Editor in Chief, The New Gastroenterologist

Introduction

Obesity is a rising pandemic. As of 2016, 93.3 million U.S. adults had obesity, representing 39.8% of our adult population.¹ It is estimated that approximately $147 billion is spent annually on caring for patients with obesity. Traditionally, the management of obesity includes lifestyle therapy (diet and exercise), pharmacotherapy (six Food and Drug Administration–approved medications for obesity), and bariatric surgery (sleeve gastrectomy [SG] and Roux-en-Y gastric bypass [RYGB]). Nevertheless, intensive lifestyle intervention and pharmacotherapy are associated with approximately 3.1%-6.6% total weight loss (TWL),^2-7 and bariatric surgery is associated with 20%-33.3% TWL.⁸ However, less than 2% of patients who are eligible for bariatric surgery elect to undergo surgery, leaving a large proportion of patients with obesity untreated or undertreated.⁹

Copyright Elsevier and AGA Institute (2017)

Endoscopic bariatric and metabolic therapies (EBMTs) encompass an emerging field for the treatment of obesity. In general, EBMTs are associated with greater weight loss than are lifestyle intervention and pharmacotherapy, but with a less- invasive risk profile than bariatric surgery. EBMTs may be divided into two general categories – gastric and small bowel interventions (Figure 1 and Table 1). Gastric EBMTs are effective at treating obesity, while small bowel EBMTs are effective at treating metabolic diseases with a variable weight loss profile depending on the device.^10,11

Of note, a variety of study designs (including retrospective series, prospective series, and randomized trials with and without shams) have been employed, which can affect outcomes. Therefore, weight loss comparisons among studies are challenging and should be considered in this context.
 

Gastric interventions

Currently, there are three types of EBMTs that are FDA approved and used for the treatment of obesity. These include intragastric balloons (IGBs), plications and suturing, and aspiration therapy (AT). Other technologies that are under investigation also will be briefly covered.

Intragastric balloons

An intragastric balloon is a space-occupying device that is placed in the stomach. The mechanism of action of IGBs involves delaying gastric emptying, which leads to increased satiety.¹² There are several types of IGBs available worldwide differing in techniques of placement and removal (endoscopic versus fluoroscopic versus swallowable), materials used to fill the balloon (fluid-filled versus air-filled), and the number of balloons placed (single versus duo versus three-balloon). At the time of this writing, three IGBs are approved by the FDA (Orbera, ReShape, and Obalon), all for patients with body mass indexes of 30-40 kg/m², and two others are in the process of obtaining FDA approval (Spatz and Elipse).

Orbera gastric balloon (Apollo Endosurgery, Austin, Tex.) is a single fluid-filled IGB that is endoscopically placed and removed at 6 months. The balloon is filled with 400-700 cc of saline with or without methylene blue (to identify leakage or rupture). Recently, Orbera365, which allows the balloon to stay for 12 months instead of 6 months, has become available in Europe; however, it is yet to be approved in the United States. The U.S. pivotal trial (Orbera trial) including 255 subjects (125 Orbera arm versus 130 non-sham control arm) demonstrated 10.2% TWL in the Orbera group compared with 3.3% TWL in the control group at 6 months based on intention-to-treat (ITT) analysis. This difference persisted at 12 months (6 months after explantation) with 7.6% TWL for the Orbera group versus 3.1% TWL for the control group.^13,14

ReShape integrated dual balloon system (ReShape Lifesciences, San Clemente, Calif.) consists of two connected fluid-filled balloons that are endoscopically placed and removed at 6 months. Each balloon is filled with 375-450 cc of saline mixed with methylene blue. The U.S. pivotal trial (REDUCE trial) including 326 subjects (187 ReShape arm versus 139 sham arm) demonstrated 6.8% TWL in the ReShape group compared with 3.3% TWL in the sham group at 6 months based on ITT analysis.^15,16

Obalon balloon system (Obalon Therapeutics, Carlsbad, Calif.) is a swallowable, gas-filled balloon system that requires endoscopy only for removal. During placement, a capsule is swallowed under fluoroscopic guidance. The balloon is then inflated with 250 cc of nitrogen mix gas prior to tube detachment. Up to three balloons may be swallowed sequentially at 1-month intervals. At 6 months from the first balloon placement, all balloons are removed endoscopically. The U.S. pivotal trial (SMART trial) including 366 subjects (185 Obalon arm versus 181 sham capsule arm) demonstrated 6.6% TWL in the Obalon group compared with 3.4% TWL in the sham group at 6 months based on ITT analysis.^17,18

Two other balloons that are currently under investigation in the United States are the Spatz3 adjustable balloon system (Spatz Medical, Great Neck, N.Y.) and Elipse balloon (Allurion Technologies, Wellesley, Mass.). The Spatz3 is a fluid-filled balloon that is placed and removed endoscopically. It consists of a single balloon and a connecting tube that allows volume adjustment for control of symptoms and possible augmentation of weight loss. The U.S. pivotal trial was recently completed and the data are being reviewed by the FDA. The Elipse is a swallowable fluid-filled balloon that does not require endoscopy for placement or removal. At 4 months, the balloon releases fluid allowing it to empty and pass naturally. The U.S. pivotal trial (ENLIGHTEN trial) is currently underway.

A meta-analysis of randomized controlled trials revealed improvement in most metabolic parameters (diastolic blood pressure, fasting glucose, hemoglobin A_1c, and waist circumference) following IGB compared with controls.¹⁹ Nausea and vomiting are seen in approximately 30% and should be addressed appropriately. Pooled serious adverse event (SAE) rate was 1.5%, which included migration, perforation, and death. Since 2016, 14 deaths have been reported according to the FDA MAUDE database. Corporate response was that over 295,000 balloons had been distributed worldwide with a mortality rate of less than 0.01%.²⁰
 

Plication and suturing

Currently, there are two endoscopic devices that are approved for the general indication of tissue apposition. These include the Incisionless Operating Platform (IOP) (USGI Medical, San Clemente, Calif.) and the Overstitch endoscopic suturing system (Apollo Endosurgery, Austin, Tex.). These devices are used to remodel the stomach to create a sleeve-like structure to induce weight loss.

The IOP system consists of a transport, which is a 54-Fr flexible endoscope. It consists of four working channels that accommodate a G-Prox (for tissue approximation), a G-Lix (for tissue grasping), and an ultrathin endoscope (for visualization). In April 2008, Horgan performed the first-in-human primary obesity surgery endoluminal (POSE) procedure in Argentina. The procedure involves the use of the IOP system to place plications primarily in the fundus to modify gastric accommodation.²¹ The U.S. pivotal trial (ESSENTIAL trial) including 332 subjects (221 POSE arm versus 111 sham arm) demonstrated 5.0% TWL in the POSE group compared with 1.4% in the sham group at 12 months based on ITT analysis.²² A European multicenter randomized controlled trial (MILEPOST trial) including 44 subjects (34 POSE arm versus 10 non-sham control arm) demonstrated 13.0% TWL in the POSE group compared with 5.3% TWL in the control group at 12 months.²³ A recent meta-analysis including five studies with 586 subjects showed pooled weight loss of 13.2% at 12-15 months following POSE with a pooled serious adverse event rate of 3.2%.²⁴ These included extraluminal bleeding, minor bleeding at the suture site, hepatic abscess, chest pain, nausea, vomiting, and abdominal pain. A distal POSE procedure with a new plication pattern focusing on the gastric body to augment the effect on gastric emptying has also been described.²⁵

The Overstitch is an endoscopic suturing device that is mounted on a double-channel endoscope. At the tip of the scope, there is a curved suture arm and an anchor exchange that allow the needle to pass back and forth to perform full-thickness bites. The tissue helix may also be placed through the second channel to grasp tissue. In April 2012, Thompson performed the first-in-human endoscopic sutured/sleeve gastroplasty (ESG) procedure in India, which was published together with cases performed in Panama and the Dominican Republic.^26-28 This procedure involves the use of the Overstitch device to place several sets of running sutures along the greater curvature of the stomach to create a sleeve-like structure. It is thought to delay gastric emptying and therefore increase satiety.²⁹ The largest multicenter retrospective study including 248 patients demonstrated 18.6% TWL at 2 years with 2% SAE rate including perigastric fluid collections, extraluminal hemorrhage, pulmonary embolism, pneumoperitoneum, and pneumothorax.³⁰

Aspiration therapy

Aspiration therapy (AT; Aspire Bariatrics, King of Prussia, Pa.) allows patients to remove 25%-30% of ingested calories at approximately 30 minutes after meals. AT consists of an A-tube, which is a 26-Fr gastrostomy tube with a 15-cm fenestrated drainage catheter placed endoscopically via a standard pull technique. At 1-2 weeks after A-tube placement, the tube is cut down to the skin and connected to the port prior to aspiration. AT is approved for patients with a BMI of 35-55 kg/m².³¹ The U.S. pivotal trial (PATHWAY trial) including 207 subjects (137 AT arm versus 70 non-sham control arm) demonstrated 12.1% TWL in the AT group compared to 3.5% in the control group at 12 months based on ITT analysis. The SAE rate was 3.6% including severe abdominal pain, peritonitis, prepyloric ulcer, and A-tube replacement due to skin-port malfunction.³²

Transpyloric shuttle

The transpyloric shuttle (TPS; BAROnova, Goleta, Calif.) consists of a spherical bulb that is attached to a smaller cylindrical bulb by a flexible tether. It is placed and removed endoscopically at 6 months. TPS resides across the pylorus creating intermittent obstruction that may result in delayed gastric emptying. A pilot study including 20 patients demonstrated 14.5% TWL at 6 months.³³ The U.S. pivotal trial (ENDObesity II trial) was recently completed and the data are being reviewed by the FDA.

Revision for weight regain following bariatric surgery

Weight regain is common following RYGB^34,35 and can be associated with dilation of the gastrojejunal anastomosis (GJA).³⁶ Several procedures have been developed to treat this condition by focusing on reduction of GJA size and are available in the United States (Figure 2). These procedures have level I evidence supporting their use and include transoral outlet reduction (TORe) and restorative obesity surgery endoluminal (ROSE).³⁷ TORe involves the use of the Overstitch to place sutures at the GJA. At 1 year, patients had 8.4% TWL with improvement in comorbidities.³⁸ Weight loss remained significant up to 3-5 years.^39,40 The modern ROSE procedure utilizes the IOP system to place plications at the GJA and distal gastric pouch following argon plasma coagulation (APC). A small series showed 12.4% TWL at 6 months.⁴¹ APC is also currently being investigated as a standalone therapy for weight regain in this population.

Small bowel interventions

There are several small bowel interventions, with different mechanisms of action, available internationally. Many of these are under investigation in the United States; however, none are currently FDA approved.

Duodenal-jejunal bypass liner

Duodenal-jejunal bypass liner (DJBL; GI Dynamics, Boston, Mass.) is a 60-cm fluoropolymer liner that is endoscopically placed and removed at 12 months. It is anchored at the duodenal bulb and ends at the jejunum. By excluding direct contact between chyme and the proximal small bowel, DJBL is thought to work via foregut mechanism where there is less inhibition of the incretin effect (greater increase in insulin secretion following oral glucose administration compared to intravenous glucose administration due to gut-derived factors that enhance insulin secretion) leading to improved insulin resistance. In addition, the enteral transit of chyme and bile is altered suggesting the possible role of the hindgut mechanism. The previous U.S. pivotal trial (ENDO trial) met efficacy endpoints. However, the study was stopped early by the company because of a hepatic abscess rate of 3.5%, all of which were treated conservatively.⁴² A new U.S. pivotal study is currently planned. A meta-analysis of 17 published studies, all of which were from outside the United States, demonstrated a significant decrease in hemoglobin A_1c of 1.3% and 18.9% TWL at 1 year following implantation in patients with obesity with concomitant diabetes.⁴³
 

Duodenal mucosal resurfacing

Duodenal mucosal resurfacing (Fractyl, Lexington, Mass.) involves saline lifting of the duodenal mucosa circumferentially prior to thermal ablation using an inflated balloon filled with heated water. It is hypothesized that this may reset the diseased duodenal enteroendocrine cells leading to restoration of the incretin effect. A pilot study including 39 patients with poorly controlled diabetes demonstrated a decrease in hemoglobin A_1c of 1.2%. The SAE rate was 7.7% including duodenal stenosis, all of which were treated with balloon dilation.⁴⁴ The U.S. pivotal trial is currently planned.

Gastroduodenal-jejunal bypass

Gastroduodenal-jejunal bypass (ValenTx., Hopkins, Minn.) is a 120-cm sleeve that is anchored at the gastroesophageal junction to create the anatomic changes of RYGB. It is placed and removed endoscopically with laparoscopic assistance. A pilot study including 12 patients demonstrated 35.9% excess weight loss at 12 months. Two out of 12 patients had early device removal due to intolerance and they were not included in the weight loss analysis.⁴⁵

Incisionless magnetic anastomosis system

The incisionless magnetic anastomosis system (GI Windows, West Bridgewater, Mass.) consists of self-assembling magnets that are deployed under fluoroscopic guidance through the working channel of colonoscopes to form magnetic octagons in the jejunum and ileum. After a week, a compression anastomosis is formed and the coupled magnets pass spontaneously. A pilot study including 10 patients showed 14.6% TWL and a decrease in hemoglobin A_1c of 1.9% (for patients with diabetes) at 1 year.⁴⁶ A randomized study outside the United States is currently underway.

Summary

Endoscopic bariatric and metabolic therapies are emerging as first-line treatments for obesity in many populations. They can serve as a gap therapy for patients who do not qualify for surgery, but also may have a specific role in the treatment of metabolic comorbidities. This field will continue to develop and improve with the introduction of personalized medicine leading to better patient selection, and newer combination therapies. It is time for gastroenterologists to become more involved in the management of this challenging condition.

Dr. Jirapinyo is an advanced and bariatric endoscopy fellow, Brigham and Women’s Hospital, Harvard Medical School, Boston; Dr. Thompson is director of therapeutic endoscopy, Brigham and Women’s Hospital, and associate professor of medicine, Harvard Medical School. Dr. Jirapinyo has served as a consultant for GI Dynamics and holds royalties for Endosim. Dr. Thompson has contracted research for Aspire Bariatrics, USGI Medical, Spatz, and Apollo Endosurgery; has served as a consultant for Boston Scientific, Covidien, USGI Medical, Olympus, and Fractyl; holds stocks and royalties for GI Windows and Endosim, and has served as an expert reviewer for GI Dynamics.
 

References

1. CDC. From https://www.cdc.gov/obesity/data/adult.html. Accessed on 11 September 2018.

2. Aronne LJ et al. Obesity. 2013;21:2163-71.

3. Torgerson JS et al. Diabetes Care. 2004;27:155-61.

4. Allison DB et al. Obesity. 2012;20:330-42.

5. Smith SR et al. N Engl J Med. 2010;363:245-56.

6. Apovian CM et al. Obesity. 2013;21:935-43.

7. Pi-Sunyer X et al. N Engl J Med. 2015;373:11-22.

8. Colguitt JL et al. Cochrane Database Syst Rev. 2014;8(8):CD003641.

9. Ponce J et al. Surg Obes Relat Dis. 2015;11(6):1199-200.

10. Jirapinyo P, Thompson CC et al. Clin Gastroenterol Hepatol. 2017;15(5):619-30.

11. Sullivan S et al.Gastroenterology. 2017;152(7):1791-801.

12. Gomez V et al. Obesity. 2016;24(9):1849-53.

13. Food and Drug Administration. Summary of safety and effectiveness data (SSED) ORBERA Intragastric Balloon System. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140008b.pdf. 2015:1-32.

14. Abu Dayyeh BK et al. Gastrointest Endosc. 2015;81:AB147.

15. Food and Drug Administration. Summary of safety and effectiveness data (SSED) ReShape Integrated Dual Balloon System. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140012b.pdf. 2015:1-43.

16. Ponce J et al. Surg Obes Relat Dis. 2015;11:874-81.

17. Food and Drug Administration. Summary and effectiveness data (SSED): Obalon Balloon System. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160001b.pdf. 2016:1-46.

18. Sullivan S et al. Gastroenterology. 2016;150:S1267.

19. Popov VB et al. Am J Gastroenterol. 2017;112:429-39.

20. Abu Dayyeh BK et al. Gastrointest Endosc. 2015;82(3):425-38.

21. Espinos JC et al. Obes Surg. 2013;23(9):1375-83.

22. Sullivan S et al. Obesity. 2017;25:294-301.

23. Miller K et al. Obesity Surg. 2017;27(2):310-22.

24. Jirapinyo P et al. Gastrointest Endosc. 2018;87(6):AB604-AB605.

25. Jirapinyo P, Thompson CC. Video GIE. 2018;3(10):296-300.

26. Campos J et al. SAGES 2013 Presentation. Baltimore, MD. 19 April 2013.

27. Kumar N et al. Gastroenterology. 2014;146(5):S571-2.

28. Kumar N et al. Surg Endosc. 2018;32(4):2159-64.

29. Abu Dayyeh BK et al. Clin Gastroenterol Hepatol. 2017;15:37-43.

30. Lopez-Nava G et al. Obes Surg. 2017;27(10):2649-55.

31. Food and Drug Administration. Summary of safety and effectiveness (SSED): AspireAssist. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf15/p150024b.pdf. FDA,ed,2016:1-36.

32. Thompson CC et al. Am J Gastroenterol. 2017;112:447-57.

33. SAGES abstract archives. SAGES. Available from: http://www.sages.org/meetings/annual-meeting/abstracts-archive/first-clinical-experience-with-the-transpyloric-shuttle-tpsr-device-a-non-surgical-endoscopic treatment-for-obesity-results-from-a-3-month-and-6-month-study. Accessed Sept. 12, 2018.

34. Sjostrom L et al. N Engl J Med. 2007;357:741-52.

35. Adams TD et al. N Engl J Med. 2017;377:1143-55.

36. Abu Dayyeh BK et al. Clin Gastroenterol Hepatol. 2011;9:228-33.

37. Thompson CC et al. Gastroenterology. 2013;145(1):129-37.

38. Jirapinyo P et al. Endoscopy. 2018;50(4):371-7.

39. Kumar N, Thompson CC. Gastrointest Endosc. 2016;83(4):776-9.

40. Jirapinyo P et al. Gastrointest Endosc. 2017;85(5):AB93-94.

41. Jirapinyo P, Thompson CC et al. Comparison of a novel plication technique to suturing for endoscopic outlet reduction for the treatment of weight regain after Roux-en-Y gastric bypass. Obesity Week 2018. Poster presentation.

42. Kaplan LM et al. EndoBarrier therapy is associated with glycemic improvement, weight loss and safety issues in patients with obesity and type 2 diabetes on oral anti-hyperglycemic agents (The ENDO Trial). In: Oral Presentation at the 76th American Diabetes Association (ADA) Annual Meeting: 2016 June 10-14: New Orleans. Abstract number 362-LB.

43. Jirapinyo P et al. Diabetes Care. 2018;41(5):1106-15.

44. Rajagopalan H et al. Diabetes Care. 2016;39(12):2254-61.

45. Sandler BJ et al. Surgical Endosc. 2015;29:3298-303.

46. Machytka E et al. Gastrointest Endosc. 2017;86(5):904-12.

Editor's Note

Gastroenterologists are becoming increasingly involved in the management of obesity. While prior therapy for obesity was mainly based on lifestyle changes, medication, or surgery, the new and exciting field of endoscopic bariatric and metabolic therapies has recently garnered incredible attention and momentum.

In this quarter’s In Focus article, brought to you by The New Gastroenterologist, Pichamol Jirapinyo and Christopher Thompson (Brigham and Women’s Hospital) provide an outstanding overview of the gastric and small bowel endoscopic interventions that are either already approved for use in obesity or currently being studied. This field is moving incredibly fast, and knowledge and understanding of these endoscopic therapies for obesity will undoubtedly be important for our field.

Bryson W. Katona, MD, PhD
Editor in Chief, The New Gastroenterologist

Introduction

Obesity is a rising pandemic. As of 2016, 93.3 million U.S. adults had obesity, representing 39.8% of our adult population.¹ It is estimated that approximately $147 billion is spent annually on caring for patients with obesity. Traditionally, the management of obesity includes lifestyle therapy (diet and exercise), pharmacotherapy (six Food and Drug Administration–approved medications for obesity), and bariatric surgery (sleeve gastrectomy [SG] and Roux-en-Y gastric bypass [RYGB]). Nevertheless, intensive lifestyle intervention and pharmacotherapy are associated with approximately 3.1%-6.6% total weight loss (TWL),^2-7 and bariatric surgery is associated with 20%-33.3% TWL.⁸ However, less than 2% of patients who are eligible for bariatric surgery elect to undergo surgery, leaving a large proportion of patients with obesity untreated or undertreated.⁹

Copyright Elsevier and AGA Institute (2017)

Endoscopic bariatric and metabolic therapies (EBMTs) encompass an emerging field for the treatment of obesity. In general, EBMTs are associated with greater weight loss than are lifestyle intervention and pharmacotherapy, but with a less- invasive risk profile than bariatric surgery. EBMTs may be divided into two general categories – gastric and small bowel interventions (Figure 1 and Table 1). Gastric EBMTs are effective at treating obesity, while small bowel EBMTs are effective at treating metabolic diseases with a variable weight loss profile depending on the device.^10,11

Of note, a variety of study designs (including retrospective series, prospective series, and randomized trials with and without shams) have been employed, which can affect outcomes. Therefore, weight loss comparisons among studies are challenging and should be considered in this context.
 

Gastric interventions

Currently, there are three types of EBMTs that are FDA approved and used for the treatment of obesity. These include intragastric balloons (IGBs), plications and suturing, and aspiration therapy (AT). Other technologies that are under investigation also will be briefly covered.

Intragastric balloons

An intragastric balloon is a space-occupying device that is placed in the stomach. The mechanism of action of IGBs involves delaying gastric emptying, which leads to increased satiety.¹² There are several types of IGBs available worldwide differing in techniques of placement and removal (endoscopic versus fluoroscopic versus swallowable), materials used to fill the balloon (fluid-filled versus air-filled), and the number of balloons placed (single versus duo versus three-balloon). At the time of this writing, three IGBs are approved by the FDA (Orbera, ReShape, and Obalon), all for patients with body mass indexes of 30-40 kg/m², and two others are in the process of obtaining FDA approval (Spatz and Elipse).

Orbera gastric balloon (Apollo Endosurgery, Austin, Tex.) is a single fluid-filled IGB that is endoscopically placed and removed at 6 months. The balloon is filled with 400-700 cc of saline with or without methylene blue (to identify leakage or rupture). Recently, Orbera365, which allows the balloon to stay for 12 months instead of 6 months, has become available in Europe; however, it is yet to be approved in the United States. The U.S. pivotal trial (Orbera trial) including 255 subjects (125 Orbera arm versus 130 non-sham control arm) demonstrated 10.2% TWL in the Orbera group compared with 3.3% TWL in the control group at 6 months based on intention-to-treat (ITT) analysis. This difference persisted at 12 months (6 months after explantation) with 7.6% TWL for the Orbera group versus 3.1% TWL for the control group.^13,14

ReShape integrated dual balloon system (ReShape Lifesciences, San Clemente, Calif.) consists of two connected fluid-filled balloons that are endoscopically placed and removed at 6 months. Each balloon is filled with 375-450 cc of saline mixed with methylene blue. The U.S. pivotal trial (REDUCE trial) including 326 subjects (187 ReShape arm versus 139 sham arm) demonstrated 6.8% TWL in the ReShape group compared with 3.3% TWL in the sham group at 6 months based on ITT analysis.^15,16

Obalon balloon system (Obalon Therapeutics, Carlsbad, Calif.) is a swallowable, gas-filled balloon system that requires endoscopy only for removal. During placement, a capsule is swallowed under fluoroscopic guidance. The balloon is then inflated with 250 cc of nitrogen mix gas prior to tube detachment. Up to three balloons may be swallowed sequentially at 1-month intervals. At 6 months from the first balloon placement, all balloons are removed endoscopically. The U.S. pivotal trial (SMART trial) including 366 subjects (185 Obalon arm versus 181 sham capsule arm) demonstrated 6.6% TWL in the Obalon group compared with 3.4% TWL in the sham group at 6 months based on ITT analysis.^17,18

Two other balloons that are currently under investigation in the United States are the Spatz3 adjustable balloon system (Spatz Medical, Great Neck, N.Y.) and Elipse balloon (Allurion Technologies, Wellesley, Mass.). The Spatz3 is a fluid-filled balloon that is placed and removed endoscopically. It consists of a single balloon and a connecting tube that allows volume adjustment for control of symptoms and possible augmentation of weight loss. The U.S. pivotal trial was recently completed and the data are being reviewed by the FDA. The Elipse is a swallowable fluid-filled balloon that does not require endoscopy for placement or removal. At 4 months, the balloon releases fluid allowing it to empty and pass naturally. The U.S. pivotal trial (ENLIGHTEN trial) is currently underway.

A meta-analysis of randomized controlled trials revealed improvement in most metabolic parameters (diastolic blood pressure, fasting glucose, hemoglobin A_1c, and waist circumference) following IGB compared with controls.¹⁹ Nausea and vomiting are seen in approximately 30% and should be addressed appropriately. Pooled serious adverse event (SAE) rate was 1.5%, which included migration, perforation, and death. Since 2016, 14 deaths have been reported according to the FDA MAUDE database. Corporate response was that over 295,000 balloons had been distributed worldwide with a mortality rate of less than 0.01%.²⁰
 

Plication and suturing

Currently, there are two endoscopic devices that are approved for the general indication of tissue apposition. These include the Incisionless Operating Platform (IOP) (USGI Medical, San Clemente, Calif.) and the Overstitch endoscopic suturing system (Apollo Endosurgery, Austin, Tex.). These devices are used to remodel the stomach to create a sleeve-like structure to induce weight loss.

The IOP system consists of a transport, which is a 54-Fr flexible endoscope. It consists of four working channels that accommodate a G-Prox (for tissue approximation), a G-Lix (for tissue grasping), and an ultrathin endoscope (for visualization). In April 2008, Horgan performed the first-in-human primary obesity surgery endoluminal (POSE) procedure in Argentina. The procedure involves the use of the IOP system to place plications primarily in the fundus to modify gastric accommodation.²¹ The U.S. pivotal trial (ESSENTIAL trial) including 332 subjects (221 POSE arm versus 111 sham arm) demonstrated 5.0% TWL in the POSE group compared with 1.4% in the sham group at 12 months based on ITT analysis.²² A European multicenter randomized controlled trial (MILEPOST trial) including 44 subjects (34 POSE arm versus 10 non-sham control arm) demonstrated 13.0% TWL in the POSE group compared with 5.3% TWL in the control group at 12 months.²³ A recent meta-analysis including five studies with 586 subjects showed pooled weight loss of 13.2% at 12-15 months following POSE with a pooled serious adverse event rate of 3.2%.²⁴ These included extraluminal bleeding, minor bleeding at the suture site, hepatic abscess, chest pain, nausea, vomiting, and abdominal pain. A distal POSE procedure with a new plication pattern focusing on the gastric body to augment the effect on gastric emptying has also been described.²⁵

The Overstitch is an endoscopic suturing device that is mounted on a double-channel endoscope. At the tip of the scope, there is a curved suture arm and an anchor exchange that allow the needle to pass back and forth to perform full-thickness bites. The tissue helix may also be placed through the second channel to grasp tissue. In April 2012, Thompson performed the first-in-human endoscopic sutured/sleeve gastroplasty (ESG) procedure in India, which was published together with cases performed in Panama and the Dominican Republic.^26-28 This procedure involves the use of the Overstitch device to place several sets of running sutures along the greater curvature of the stomach to create a sleeve-like structure. It is thought to delay gastric emptying and therefore increase satiety.²⁹ The largest multicenter retrospective study including 248 patients demonstrated 18.6% TWL at 2 years with 2% SAE rate including perigastric fluid collections, extraluminal hemorrhage, pulmonary embolism, pneumoperitoneum, and pneumothorax.³⁰

Aspiration therapy

Aspiration therapy (AT; Aspire Bariatrics, King of Prussia, Pa.) allows patients to remove 25%-30% of ingested calories at approximately 30 minutes after meals. AT consists of an A-tube, which is a 26-Fr gastrostomy tube with a 15-cm fenestrated drainage catheter placed endoscopically via a standard pull technique. At 1-2 weeks after A-tube placement, the tube is cut down to the skin and connected to the port prior to aspiration. AT is approved for patients with a BMI of 35-55 kg/m².³¹ The U.S. pivotal trial (PATHWAY trial) including 207 subjects (137 AT arm versus 70 non-sham control arm) demonstrated 12.1% TWL in the AT group compared to 3.5% in the control group at 12 months based on ITT analysis. The SAE rate was 3.6% including severe abdominal pain, peritonitis, prepyloric ulcer, and A-tube replacement due to skin-port malfunction.³²

Transpyloric shuttle

The transpyloric shuttle (TPS; BAROnova, Goleta, Calif.) consists of a spherical bulb that is attached to a smaller cylindrical bulb by a flexible tether. It is placed and removed endoscopically at 6 months. TPS resides across the pylorus creating intermittent obstruction that may result in delayed gastric emptying. A pilot study including 20 patients demonstrated 14.5% TWL at 6 months.³³ The U.S. pivotal trial (ENDObesity II trial) was recently completed and the data are being reviewed by the FDA.

Revision for weight regain following bariatric surgery

Weight regain is common following RYGB^34,35 and can be associated with dilation of the gastrojejunal anastomosis (GJA).³⁶ Several procedures have been developed to treat this condition by focusing on reduction of GJA size and are available in the United States (Figure 2). These procedures have level I evidence supporting their use and include transoral outlet reduction (TORe) and restorative obesity surgery endoluminal (ROSE).³⁷ TORe involves the use of the Overstitch to place sutures at the GJA. At 1 year, patients had 8.4% TWL with improvement in comorbidities.³⁸ Weight loss remained significant up to 3-5 years.^39,40 The modern ROSE procedure utilizes the IOP system to place plications at the GJA and distal gastric pouch following argon plasma coagulation (APC). A small series showed 12.4% TWL at 6 months.⁴¹ APC is also currently being investigated as a standalone therapy for weight regain in this population.

Small bowel interventions

There are several small bowel interventions, with different mechanisms of action, available internationally. Many of these are under investigation in the United States; however, none are currently FDA approved.

Duodenal-jejunal bypass liner

Duodenal-jejunal bypass liner (DJBL; GI Dynamics, Boston, Mass.) is a 60-cm fluoropolymer liner that is endoscopically placed and removed at 12 months. It is anchored at the duodenal bulb and ends at the jejunum. By excluding direct contact between chyme and the proximal small bowel, DJBL is thought to work via foregut mechanism where there is less inhibition of the incretin effect (greater increase in insulin secretion following oral glucose administration compared to intravenous glucose administration due to gut-derived factors that enhance insulin secretion) leading to improved insulin resistance. In addition, the enteral transit of chyme and bile is altered suggesting the possible role of the hindgut mechanism. The previous U.S. pivotal trial (ENDO trial) met efficacy endpoints. However, the study was stopped early by the company because of a hepatic abscess rate of 3.5%, all of which were treated conservatively.⁴² A new U.S. pivotal study is currently planned. A meta-analysis of 17 published studies, all of which were from outside the United States, demonstrated a significant decrease in hemoglobin A_1c of 1.3% and 18.9% TWL at 1 year following implantation in patients with obesity with concomitant diabetes.⁴³
 

Duodenal mucosal resurfacing

Duodenal mucosal resurfacing (Fractyl, Lexington, Mass.) involves saline lifting of the duodenal mucosa circumferentially prior to thermal ablation using an inflated balloon filled with heated water. It is hypothesized that this may reset the diseased duodenal enteroendocrine cells leading to restoration of the incretin effect. A pilot study including 39 patients with poorly controlled diabetes demonstrated a decrease in hemoglobin A_1c of 1.2%. The SAE rate was 7.7% including duodenal stenosis, all of which were treated with balloon dilation.⁴⁴ The U.S. pivotal trial is currently planned.

Gastroduodenal-jejunal bypass

Gastroduodenal-jejunal bypass (ValenTx., Hopkins, Minn.) is a 120-cm sleeve that is anchored at the gastroesophageal junction to create the anatomic changes of RYGB. It is placed and removed endoscopically with laparoscopic assistance. A pilot study including 12 patients demonstrated 35.9% excess weight loss at 12 months. Two out of 12 patients had early device removal due to intolerance and they were not included in the weight loss analysis.⁴⁵

Incisionless magnetic anastomosis system

The incisionless magnetic anastomosis system (GI Windows, West Bridgewater, Mass.) consists of self-assembling magnets that are deployed under fluoroscopic guidance through the working channel of colonoscopes to form magnetic octagons in the jejunum and ileum. After a week, a compression anastomosis is formed and the coupled magnets pass spontaneously. A pilot study including 10 patients showed 14.6% TWL and a decrease in hemoglobin A_1c of 1.9% (for patients with diabetes) at 1 year.⁴⁶ A randomized study outside the United States is currently underway.

Summary

Endoscopic bariatric and metabolic therapies are emerging as first-line treatments for obesity in many populations. They can serve as a gap therapy for patients who do not qualify for surgery, but also may have a specific role in the treatment of metabolic comorbidities. This field will continue to develop and improve with the introduction of personalized medicine leading to better patient selection, and newer combination therapies. It is time for gastroenterologists to become more involved in the management of this challenging condition.

Dr. Jirapinyo is an advanced and bariatric endoscopy fellow, Brigham and Women’s Hospital, Harvard Medical School, Boston; Dr. Thompson is director of therapeutic endoscopy, Brigham and Women’s Hospital, and associate professor of medicine, Harvard Medical School. Dr. Jirapinyo has served as a consultant for GI Dynamics and holds royalties for Endosim. Dr. Thompson has contracted research for Aspire Bariatrics, USGI Medical, Spatz, and Apollo Endosurgery; has served as a consultant for Boston Scientific, Covidien, USGI Medical, Olympus, and Fractyl; holds stocks and royalties for GI Windows and Endosim, and has served as an expert reviewer for GI Dynamics.
 

References

1. CDC. From https://www.cdc.gov/obesity/data/adult.html. Accessed on 11 September 2018.

2. Aronne LJ et al. Obesity. 2013;21:2163-71.

3. Torgerson JS et al. Diabetes Care. 2004;27:155-61.

4. Allison DB et al. Obesity. 2012;20:330-42.

5. Smith SR et al. N Engl J Med. 2010;363:245-56.

6. Apovian CM et al. Obesity. 2013;21:935-43.

7. Pi-Sunyer X et al. N Engl J Med. 2015;373:11-22.

8. Colguitt JL et al. Cochrane Database Syst Rev. 2014;8(8):CD003641.

9. Ponce J et al. Surg Obes Relat Dis. 2015;11(6):1199-200.

10. Jirapinyo P, Thompson CC et al. Clin Gastroenterol Hepatol. 2017;15(5):619-30.

11. Sullivan S et al.Gastroenterology. 2017;152(7):1791-801.

12. Gomez V et al. Obesity. 2016;24(9):1849-53.

13. Food and Drug Administration. Summary of safety and effectiveness data (SSED) ORBERA Intragastric Balloon System. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140008b.pdf. 2015:1-32.

14. Abu Dayyeh BK et al. Gastrointest Endosc. 2015;81:AB147.

15. Food and Drug Administration. Summary of safety and effectiveness data (SSED) ReShape Integrated Dual Balloon System. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140012b.pdf. 2015:1-43.

16. Ponce J et al. Surg Obes Relat Dis. 2015;11:874-81.

17. Food and Drug Administration. Summary and effectiveness data (SSED): Obalon Balloon System. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160001b.pdf. 2016:1-46.

18. Sullivan S et al. Gastroenterology. 2016;150:S1267.

19. Popov VB et al. Am J Gastroenterol. 2017;112:429-39.

20. Abu Dayyeh BK et al. Gastrointest Endosc. 2015;82(3):425-38.

21. Espinos JC et al. Obes Surg. 2013;23(9):1375-83.

22. Sullivan S et al. Obesity. 2017;25:294-301.

23. Miller K et al. Obesity Surg. 2017;27(2):310-22.

24. Jirapinyo P et al. Gastrointest Endosc. 2018;87(6):AB604-AB605.

25. Jirapinyo P, Thompson CC. Video GIE. 2018;3(10):296-300.

26. Campos J et al. SAGES 2013 Presentation. Baltimore, MD. 19 April 2013.

27. Kumar N et al. Gastroenterology. 2014;146(5):S571-2.

28. Kumar N et al. Surg Endosc. 2018;32(4):2159-64.

29. Abu Dayyeh BK et al. Clin Gastroenterol Hepatol. 2017;15:37-43.

30. Lopez-Nava G et al. Obes Surg. 2017;27(10):2649-55.

31. Food and Drug Administration. Summary of safety and effectiveness (SSED): AspireAssist. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf15/p150024b.pdf. FDA,ed,2016:1-36.

32. Thompson CC et al. Am J Gastroenterol. 2017;112:447-57.

33. SAGES abstract archives. SAGES. Available from: http://www.sages.org/meetings/annual-meeting/abstracts-archive/first-clinical-experience-with-the-transpyloric-shuttle-tpsr-device-a-non-surgical-endoscopic treatment-for-obesity-results-from-a-3-month-and-6-month-study. Accessed Sept. 12, 2018.

34. Sjostrom L et al. N Engl J Med. 2007;357:741-52.

35. Adams TD et al. N Engl J Med. 2017;377:1143-55.

36. Abu Dayyeh BK et al. Clin Gastroenterol Hepatol. 2011;9:228-33.

37. Thompson CC et al. Gastroenterology. 2013;145(1):129-37.

38. Jirapinyo P et al. Endoscopy. 2018;50(4):371-7.

39. Kumar N, Thompson CC. Gastrointest Endosc. 2016;83(4):776-9.

40. Jirapinyo P et al. Gastrointest Endosc. 2017;85(5):AB93-94.

41. Jirapinyo P, Thompson CC et al. Comparison of a novel plication technique to suturing for endoscopic outlet reduction for the treatment of weight regain after Roux-en-Y gastric bypass. Obesity Week 2018. Poster presentation.

42. Kaplan LM et al. EndoBarrier therapy is associated with glycemic improvement, weight loss and safety issues in patients with obesity and type 2 diabetes on oral anti-hyperglycemic agents (The ENDO Trial). In: Oral Presentation at the 76th American Diabetes Association (ADA) Annual Meeting: 2016 June 10-14: New Orleans. Abstract number 362-LB.

43. Jirapinyo P et al. Diabetes Care. 2018;41(5):1106-15.

44. Rajagopalan H et al. Diabetes Care. 2016;39(12):2254-61.

45. Sandler BJ et al. Surgical Endosc. 2015;29:3298-303.

46. Machytka E et al. Gastrointest Endosc. 2017;86(5):904-12.

Editor's Note

Gastroenterologists are becoming increasingly involved in the management of obesity. While prior therapy for obesity was mainly based on lifestyle changes, medication, or surgery, the new and exciting field of endoscopic bariatric and metabolic therapies has recently garnered incredible attention and momentum.

In this quarter’s In Focus article, brought to you by The New Gastroenterologist, Pichamol Jirapinyo and Christopher Thompson (Brigham and Women’s Hospital) provide an outstanding overview of the gastric and small bowel endoscopic interventions that are either already approved for use in obesity or currently being studied. This field is moving incredibly fast, and knowledge and understanding of these endoscopic therapies for obesity will undoubtedly be important for our field.

Bryson W. Katona, MD, PhD
Editor in Chief, The New Gastroenterologist

Introduction

Obesity is a rising pandemic. As of 2016, 93.3 million U.S. adults had obesity, representing 39.8% of our adult population.¹ It is estimated that approximately $147 billion is spent annually on caring for patients with obesity. Traditionally, the management of obesity includes lifestyle therapy (diet and exercise), pharmacotherapy (six Food and Drug Administration–approved medications for obesity), and bariatric surgery (sleeve gastrectomy [SG] and Roux-en-Y gastric bypass [RYGB]). Nevertheless, intensive lifestyle intervention and pharmacotherapy are associated with approximately 3.1%-6.6% total weight loss (TWL),^2-7 and bariatric surgery is associated with 20%-33.3% TWL.⁸ However, less than 2% of patients who are eligible for bariatric surgery elect to undergo surgery, leaving a large proportion of patients with obesity untreated or undertreated.⁹

Copyright Elsevier and AGA Institute (2017)

Endoscopic bariatric and metabolic therapies (EBMTs) encompass an emerging field for the treatment of obesity. In general, EBMTs are associated with greater weight loss than are lifestyle intervention and pharmacotherapy, but with a less- invasive risk profile than bariatric surgery. EBMTs may be divided into two general categories – gastric and small bowel interventions (Figure 1 and Table 1). Gastric EBMTs are effective at treating obesity, while small bowel EBMTs are effective at treating metabolic diseases with a variable weight loss profile depending on the device.^10,11

Of note, a variety of study designs (including retrospective series, prospective series, and randomized trials with and without shams) have been employed, which can affect outcomes. Therefore, weight loss comparisons among studies are challenging and should be considered in this context.
 

Gastric interventions

Currently, there are three types of EBMTs that are FDA approved and used for the treatment of obesity. These include intragastric balloons (IGBs), plications and suturing, and aspiration therapy (AT). Other technologies that are under investigation also will be briefly covered.

Intragastric balloons

An intragastric balloon is a space-occupying device that is placed in the stomach. The mechanism of action of IGBs involves delaying gastric emptying, which leads to increased satiety.¹² There are several types of IGBs available worldwide differing in techniques of placement and removal (endoscopic versus fluoroscopic versus swallowable), materials used to fill the balloon (fluid-filled versus air-filled), and the number of balloons placed (single versus duo versus three-balloon). At the time of this writing, three IGBs are approved by the FDA (Orbera, ReShape, and Obalon), all for patients with body mass indexes of 30-40 kg/m², and two others are in the process of obtaining FDA approval (Spatz and Elipse).

Orbera gastric balloon (Apollo Endosurgery, Austin, Tex.) is a single fluid-filled IGB that is endoscopically placed and removed at 6 months. The balloon is filled with 400-700 cc of saline with or without methylene blue (to identify leakage or rupture). Recently, Orbera365, which allows the balloon to stay for 12 months instead of 6 months, has become available in Europe; however, it is yet to be approved in the United States. The U.S. pivotal trial (Orbera trial) including 255 subjects (125 Orbera arm versus 130 non-sham control arm) demonstrated 10.2% TWL in the Orbera group compared with 3.3% TWL in the control group at 6 months based on intention-to-treat (ITT) analysis. This difference persisted at 12 months (6 months after explantation) with 7.6% TWL for the Orbera group versus 3.1% TWL for the control group.^13,14

ReShape integrated dual balloon system (ReShape Lifesciences, San Clemente, Calif.) consists of two connected fluid-filled balloons that are endoscopically placed and removed at 6 months. Each balloon is filled with 375-450 cc of saline mixed with methylene blue. The U.S. pivotal trial (REDUCE trial) including 326 subjects (187 ReShape arm versus 139 sham arm) demonstrated 6.8% TWL in the ReShape group compared with 3.3% TWL in the sham group at 6 months based on ITT analysis.^15,16

Obalon balloon system (Obalon Therapeutics, Carlsbad, Calif.) is a swallowable, gas-filled balloon system that requires endoscopy only for removal. During placement, a capsule is swallowed under fluoroscopic guidance. The balloon is then inflated with 250 cc of nitrogen mix gas prior to tube detachment. Up to three balloons may be swallowed sequentially at 1-month intervals. At 6 months from the first balloon placement, all balloons are removed endoscopically. The U.S. pivotal trial (SMART trial) including 366 subjects (185 Obalon arm versus 181 sham capsule arm) demonstrated 6.6% TWL in the Obalon group compared with 3.4% TWL in the sham group at 6 months based on ITT analysis.^17,18

Two other balloons that are currently under investigation in the United States are the Spatz3 adjustable balloon system (Spatz Medical, Great Neck, N.Y.) and Elipse balloon (Allurion Technologies, Wellesley, Mass.). The Spatz3 is a fluid-filled balloon that is placed and removed endoscopically. It consists of a single balloon and a connecting tube that allows volume adjustment for control of symptoms and possible augmentation of weight loss. The U.S. pivotal trial was recently completed and the data are being reviewed by the FDA. The Elipse is a swallowable fluid-filled balloon that does not require endoscopy for placement or removal. At 4 months, the balloon releases fluid allowing it to empty and pass naturally. The U.S. pivotal trial (ENLIGHTEN trial) is currently underway.

A meta-analysis of randomized controlled trials revealed improvement in most metabolic parameters (diastolic blood pressure, fasting glucose, hemoglobin A_1c, and waist circumference) following IGB compared with controls.¹⁹ Nausea and vomiting are seen in approximately 30% and should be addressed appropriately. Pooled serious adverse event (SAE) rate was 1.5%, which included migration, perforation, and death. Since 2016, 14 deaths have been reported according to the FDA MAUDE database. Corporate response was that over 295,000 balloons had been distributed worldwide with a mortality rate of less than 0.01%.²⁰
 

Plication and suturing

Currently, there are two endoscopic devices that are approved for the general indication of tissue apposition. These include the Incisionless Operating Platform (IOP) (USGI Medical, San Clemente, Calif.) and the Overstitch endoscopic suturing system (Apollo Endosurgery, Austin, Tex.). These devices are used to remodel the stomach to create a sleeve-like structure to induce weight loss.

The IOP system consists of a transport, which is a 54-Fr flexible endoscope. It consists of four working channels that accommodate a G-Prox (for tissue approximation), a G-Lix (for tissue grasping), and an ultrathin endoscope (for visualization). In April 2008, Horgan performed the first-in-human primary obesity surgery endoluminal (POSE) procedure in Argentina. The procedure involves the use of the IOP system to place plications primarily in the fundus to modify gastric accommodation.²¹ The U.S. pivotal trial (ESSENTIAL trial) including 332 subjects (221 POSE arm versus 111 sham arm) demonstrated 5.0% TWL in the POSE group compared with 1.4% in the sham group at 12 months based on ITT analysis.²² A European multicenter randomized controlled trial (MILEPOST trial) including 44 subjects (34 POSE arm versus 10 non-sham control arm) demonstrated 13.0% TWL in the POSE group compared with 5.3% TWL in the control group at 12 months.²³ A recent meta-analysis including five studies with 586 subjects showed pooled weight loss of 13.2% at 12-15 months following POSE with a pooled serious adverse event rate of 3.2%.²⁴ These included extraluminal bleeding, minor bleeding at the suture site, hepatic abscess, chest pain, nausea, vomiting, and abdominal pain. A distal POSE procedure with a new plication pattern focusing on the gastric body to augment the effect on gastric emptying has also been described.²⁵

The Overstitch is an endoscopic suturing device that is mounted on a double-channel endoscope. At the tip of the scope, there is a curved suture arm and an anchor exchange that allow the needle to pass back and forth to perform full-thickness bites. The tissue helix may also be placed through the second channel to grasp tissue. In April 2012, Thompson performed the first-in-human endoscopic sutured/sleeve gastroplasty (ESG) procedure in India, which was published together with cases performed in Panama and the Dominican Republic.^26-28 This procedure involves the use of the Overstitch device to place several sets of running sutures along the greater curvature of the stomach to create a sleeve-like structure. It is thought to delay gastric emptying and therefore increase satiety.²⁹ The largest multicenter retrospective study including 248 patients demonstrated 18.6% TWL at 2 years with 2% SAE rate including perigastric fluid collections, extraluminal hemorrhage, pulmonary embolism, pneumoperitoneum, and pneumothorax.³⁰

Aspiration therapy

Aspiration therapy (AT; Aspire Bariatrics, King of Prussia, Pa.) allows patients to remove 25%-30% of ingested calories at approximately 30 minutes after meals. AT consists of an A-tube, which is a 26-Fr gastrostomy tube with a 15-cm fenestrated drainage catheter placed endoscopically via a standard pull technique. At 1-2 weeks after A-tube placement, the tube is cut down to the skin and connected to the port prior to aspiration. AT is approved for patients with a BMI of 35-55 kg/m².³¹ The U.S. pivotal trial (PATHWAY trial) including 207 subjects (137 AT arm versus 70 non-sham control arm) demonstrated 12.1% TWL in the AT group compared to 3.5% in the control group at 12 months based on ITT analysis. The SAE rate was 3.6% including severe abdominal pain, peritonitis, prepyloric ulcer, and A-tube replacement due to skin-port malfunction.³²

Transpyloric shuttle

The transpyloric shuttle (TPS; BAROnova, Goleta, Calif.) consists of a spherical bulb that is attached to a smaller cylindrical bulb by a flexible tether. It is placed and removed endoscopically at 6 months. TPS resides across the pylorus creating intermittent obstruction that may result in delayed gastric emptying. A pilot study including 20 patients demonstrated 14.5% TWL at 6 months.³³ The U.S. pivotal trial (ENDObesity II trial) was recently completed and the data are being reviewed by the FDA.

Revision for weight regain following bariatric surgery

Weight regain is common following RYGB^34,35 and can be associated with dilation of the gastrojejunal anastomosis (GJA).³⁶ Several procedures have been developed to treat this condition by focusing on reduction of GJA size and are available in the United States (Figure 2). These procedures have level I evidence supporting their use and include transoral outlet reduction (TORe) and restorative obesity surgery endoluminal (ROSE).³⁷ TORe involves the use of the Overstitch to place sutures at the GJA. At 1 year, patients had 8.4% TWL with improvement in comorbidities.³⁸ Weight loss remained significant up to 3-5 years.^39,40 The modern ROSE procedure utilizes the IOP system to place plications at the GJA and distal gastric pouch following argon plasma coagulation (APC). A small series showed 12.4% TWL at 6 months.⁴¹ APC is also currently being investigated as a standalone therapy for weight regain in this population.

Small bowel interventions

There are several small bowel interventions, with different mechanisms of action, available internationally. Many of these are under investigation in the United States; however, none are currently FDA approved.

Duodenal-jejunal bypass liner

Duodenal-jejunal bypass liner (DJBL; GI Dynamics, Boston, Mass.) is a 60-cm fluoropolymer liner that is endoscopically placed and removed at 12 months. It is anchored at the duodenal bulb and ends at the jejunum. By excluding direct contact between chyme and the proximal small bowel, DJBL is thought to work via foregut mechanism where there is less inhibition of the incretin effect (greater increase in insulin secretion following oral glucose administration compared to intravenous glucose administration due to gut-derived factors that enhance insulin secretion) leading to improved insulin resistance. In addition, the enteral transit of chyme and bile is altered suggesting the possible role of the hindgut mechanism. The previous U.S. pivotal trial (ENDO trial) met efficacy endpoints. However, the study was stopped early by the company because of a hepatic abscess rate of 3.5%, all of which were treated conservatively.⁴² A new U.S. pivotal study is currently planned. A meta-analysis of 17 published studies, all of which were from outside the United States, demonstrated a significant decrease in hemoglobin A_1c of 1.3% and 18.9% TWL at 1 year following implantation in patients with obesity with concomitant diabetes.⁴³
 

Duodenal mucosal resurfacing

Duodenal mucosal resurfacing (Fractyl, Lexington, Mass.) involves saline lifting of the duodenal mucosa circumferentially prior to thermal ablation using an inflated balloon filled with heated water. It is hypothesized that this may reset the diseased duodenal enteroendocrine cells leading to restoration of the incretin effect. A pilot study including 39 patients with poorly controlled diabetes demonstrated a decrease in hemoglobin A_1c of 1.2%. The SAE rate was 7.7% including duodenal stenosis, all of which were treated with balloon dilation.⁴⁴ The U.S. pivotal trial is currently planned.

Gastroduodenal-jejunal bypass

Gastroduodenal-jejunal bypass (ValenTx., Hopkins, Minn.) is a 120-cm sleeve that is anchored at the gastroesophageal junction to create the anatomic changes of RYGB. It is placed and removed endoscopically with laparoscopic assistance. A pilot study including 12 patients demonstrated 35.9% excess weight loss at 12 months. Two out of 12 patients had early device removal due to intolerance and they were not included in the weight loss analysis.⁴⁵

Incisionless magnetic anastomosis system

The incisionless magnetic anastomosis system (GI Windows, West Bridgewater, Mass.) consists of self-assembling magnets that are deployed under fluoroscopic guidance through the working channel of colonoscopes to form magnetic octagons in the jejunum and ileum. After a week, a compression anastomosis is formed and the coupled magnets pass spontaneously. A pilot study including 10 patients showed 14.6% TWL and a decrease in hemoglobin A_1c of 1.9% (for patients with diabetes) at 1 year.⁴⁶ A randomized study outside the United States is currently underway.

Summary

Endoscopic bariatric and metabolic therapies are emerging as first-line treatments for obesity in many populations. They can serve as a gap therapy for patients who do not qualify for surgery, but also may have a specific role in the treatment of metabolic comorbidities. This field will continue to develop and improve with the introduction of personalized medicine leading to better patient selection, and newer combination therapies. It is time for gastroenterologists to become more involved in the management of this challenging condition.

Dr. Jirapinyo is an advanced and bariatric endoscopy fellow, Brigham and Women’s Hospital, Harvard Medical School, Boston; Dr. Thompson is director of therapeutic endoscopy, Brigham and Women’s Hospital, and associate professor of medicine, Harvard Medical School. Dr. Jirapinyo has served as a consultant for GI Dynamics and holds royalties for Endosim. Dr. Thompson has contracted research for Aspire Bariatrics, USGI Medical, Spatz, and Apollo Endosurgery; has served as a consultant for Boston Scientific, Covidien, USGI Medical, Olympus, and Fractyl; holds stocks and royalties for GI Windows and Endosim, and has served as an expert reviewer for GI Dynamics.
 

References

1. CDC. From https://www.cdc.gov/obesity/data/adult.html. Accessed on 11 September 2018.

2. Aronne LJ et al. Obesity. 2013;21:2163-71.

3. Torgerson JS et al. Diabetes Care. 2004;27:155-61.

4. Allison DB et al. Obesity. 2012;20:330-42.

5. Smith SR et al. N Engl J Med. 2010;363:245-56.

6. Apovian CM et al. Obesity. 2013;21:935-43.

7. Pi-Sunyer X et al. N Engl J Med. 2015;373:11-22.

8. Colguitt JL et al. Cochrane Database Syst Rev. 2014;8(8):CD003641.

9. Ponce J et al. Surg Obes Relat Dis. 2015;11(6):1199-200.

10. Jirapinyo P, Thompson CC et al. Clin Gastroenterol Hepatol. 2017;15(5):619-30.

11. Sullivan S et al.Gastroenterology. 2017;152(7):1791-801.

12. Gomez V et al. Obesity. 2016;24(9):1849-53.

13. Food and Drug Administration. Summary of safety and effectiveness data (SSED) ORBERA Intragastric Balloon System. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140008b.pdf. 2015:1-32.

14. Abu Dayyeh BK et al. Gastrointest Endosc. 2015;81:AB147.

15. Food and Drug Administration. Summary of safety and effectiveness data (SSED) ReShape Integrated Dual Balloon System. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140012b.pdf. 2015:1-43.

16. Ponce J et al. Surg Obes Relat Dis. 2015;11:874-81.

17. Food and Drug Administration. Summary and effectiveness data (SSED): Obalon Balloon System. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160001b.pdf. 2016:1-46.

18. Sullivan S et al. Gastroenterology. 2016;150:S1267.

19. Popov VB et al. Am J Gastroenterol. 2017;112:429-39.

20. Abu Dayyeh BK et al. Gastrointest Endosc. 2015;82(3):425-38.

21. Espinos JC et al. Obes Surg. 2013;23(9):1375-83.

22. Sullivan S et al. Obesity. 2017;25:294-301.

23. Miller K et al. Obesity Surg. 2017;27(2):310-22.

24. Jirapinyo P et al. Gastrointest Endosc. 2018;87(6):AB604-AB605.

25. Jirapinyo P, Thompson CC. Video GIE. 2018;3(10):296-300.

26. Campos J et al. SAGES 2013 Presentation. Baltimore, MD. 19 April 2013.

27. Kumar N et al. Gastroenterology. 2014;146(5):S571-2.

28. Kumar N et al. Surg Endosc. 2018;32(4):2159-64.

29. Abu Dayyeh BK et al. Clin Gastroenterol Hepatol. 2017;15:37-43.

30. Lopez-Nava G et al. Obes Surg. 2017;27(10):2649-55.

31. Food and Drug Administration. Summary of safety and effectiveness (SSED): AspireAssist. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf15/p150024b.pdf. FDA,ed,2016:1-36.

32. Thompson CC et al. Am J Gastroenterol. 2017;112:447-57.

33. SAGES abstract archives. SAGES. Available from: http://www.sages.org/meetings/annual-meeting/abstracts-archive/first-clinical-experience-with-the-transpyloric-shuttle-tpsr-device-a-non-surgical-endoscopic treatment-for-obesity-results-from-a-3-month-and-6-month-study. Accessed Sept. 12, 2018.

34. Sjostrom L et al. N Engl J Med. 2007;357:741-52.

35. Adams TD et al. N Engl J Med. 2017;377:1143-55.

36. Abu Dayyeh BK et al. Clin Gastroenterol Hepatol. 2011;9:228-33.

37. Thompson CC et al. Gastroenterology. 2013;145(1):129-37.

38. Jirapinyo P et al. Endoscopy. 2018;50(4):371-7.

39. Kumar N, Thompson CC. Gastrointest Endosc. 2016;83(4):776-9.

40. Jirapinyo P et al. Gastrointest Endosc. 2017;85(5):AB93-94.

41. Jirapinyo P, Thompson CC et al. Comparison of a novel plication technique to suturing for endoscopic outlet reduction for the treatment of weight regain after Roux-en-Y gastric bypass. Obesity Week 2018. Poster presentation.

42. Kaplan LM et al. EndoBarrier therapy is associated with glycemic improvement, weight loss and safety issues in patients with obesity and type 2 diabetes on oral anti-hyperglycemic agents (The ENDO Trial). In: Oral Presentation at the 76th American Diabetes Association (ADA) Annual Meeting: 2016 June 10-14: New Orleans. Abstract number 362-LB.

43. Jirapinyo P et al. Diabetes Care. 2018;41(5):1106-15.

44. Rajagopalan H et al. Diabetes Care. 2016;39(12):2254-61.

45. Sandler BJ et al. Surgical Endosc. 2015;29:3298-303.

46. Machytka E et al. Gastrointest Endosc. 2017;86(5):904-12.

On Sept. 14, AGA held Advocacy Day. This was a day in which several AGA members met with staff of Congressional representatives on Capitol Hill to advocate for important issues within the field of gastroenterology. The three primary issues involved:

• Support of increased NIH funding.
• Requesting increased transparency in insurance-driven step-therapy protocols.
• Removal of the coinsurance or copayment for screening colonoscopies that become therapeutic, once polyps are identified and removed.

These issues support growth and autonomy of our field, while supporting the interests of our patients.

Advocacy is not difficult. Many of my fellow GIs are unnecessarily intimidated by this word; however, each individual has the ability and, arguably, the responsibility to shape the environment in which we practice. Opportunities to engage your representatives may be as simple as clicking a link, leaving a voicemail, or signing a petition, to testifying at hearings or hosting a representative at your own institution. AGA staff made participating in Advocacy Day very easy. Staff at AGA coordinate meetings between each advocate, and the offices of his or her local Congress members. AGA also provides brief training prior to these meetings; thus, no prior experience is required. I felt well prepared for the meetings with my local Congress staff members.

I chose to participate in Advocacy Day because I want to bring the experiences of my colleagues and patients to the doorsteps of those who make decisions about how we practice. I feel that it is important to stand up for our field and our patients, lest others make decisions for us. We do not have to feel powerless in a changing field. Let your voice be heard.

Dr. Anjou is a gastroenterologist at the University of Connecticut Health Center, Farmington, and member of the AGA Trainee and Early Career Committee and Quality Measures Committee.

On Sept. 14, AGA held Advocacy Day. This was a day in which several AGA members met with staff of Congressional representatives on Capitol Hill to advocate for important issues within the field of gastroenterology. The three primary issues involved:

• Support of increased NIH funding.
• Requesting increased transparency in insurance-driven step-therapy protocols.
• Removal of the coinsurance or copayment for screening colonoscopies that become therapeutic, once polyps are identified and removed.

These issues support growth and autonomy of our field, while supporting the interests of our patients.

Advocacy is not difficult. Many of my fellow GIs are unnecessarily intimidated by this word; however, each individual has the ability and, arguably, the responsibility to shape the environment in which we practice. Opportunities to engage your representatives may be as simple as clicking a link, leaving a voicemail, or signing a petition, to testifying at hearings or hosting a representative at your own institution. AGA staff made participating in Advocacy Day very easy. Staff at AGA coordinate meetings between each advocate, and the offices of his or her local Congress members. AGA also provides brief training prior to these meetings; thus, no prior experience is required. I felt well prepared for the meetings with my local Congress staff members.

I chose to participate in Advocacy Day because I want to bring the experiences of my colleagues and patients to the doorsteps of those who make decisions about how we practice. I feel that it is important to stand up for our field and our patients, lest others make decisions for us. We do not have to feel powerless in a changing field. Let your voice be heard.

Dr. Anjou is a gastroenterologist at the University of Connecticut Health Center, Farmington, and member of the AGA Trainee and Early Career Committee and Quality Measures Committee.

On Sept. 14, AGA held Advocacy Day. This was a day in which several AGA members met with staff of Congressional representatives on Capitol Hill to advocate for important issues within the field of gastroenterology. The three primary issues involved:

• Support of increased NIH funding.
• Requesting increased transparency in insurance-driven step-therapy protocols.
• Removal of the coinsurance or copayment for screening colonoscopies that become therapeutic, once polyps are identified and removed.

These issues support growth and autonomy of our field, while supporting the interests of our patients.

Advocacy is not difficult. Many of my fellow GIs are unnecessarily intimidated by this word; however, each individual has the ability and, arguably, the responsibility to shape the environment in which we practice. Opportunities to engage your representatives may be as simple as clicking a link, leaving a voicemail, or signing a petition, to testifying at hearings or hosting a representative at your own institution. AGA staff made participating in Advocacy Day very easy. Staff at AGA coordinate meetings between each advocate, and the offices of his or her local Congress members. AGA also provides brief training prior to these meetings; thus, no prior experience is required. I felt well prepared for the meetings with my local Congress staff members.

I chose to participate in Advocacy Day because I want to bring the experiences of my colleagues and patients to the doorsteps of those who make decisions about how we practice. I feel that it is important to stand up for our field and our patients, lest others make decisions for us. We do not have to feel powerless in a changing field. Let your voice be heard.

Dr. Anjou is a gastroenterologist at the University of Connecticut Health Center, Farmington, and member of the AGA Trainee and Early Career Committee and Quality Measures Committee.

We spoke with Dr. Shen, instructor of medicine at the University of Pennsylvania and the recipient of the AGA Research Foundation’s 2016 Microbiome Junior Investigator Award, to learn about his passion for gut microbiome research.

How would you sum up your research in one sentence?

My research examines the metabolic interactions between the gut microbiota and the mammalian host, with a particular emphasis on amino acid metabolism and nitrogen flux via the bacterial enzyme urease.

What impact do you hope your research will have on patients?

My hope is that by better understanding the biological mechanisms by which the gut microbiota impacts host metabolism, we can modulate its effects to treat a variety of conditions and diseases including hepatic encephalopathy, inborn errors of metabolism, obesity, malnutrition, etc.

What inspired you to focus your research career on the gut microbiome?

My clinical experience as a gastroenterologist inspired my interest in metabolic and nutritional research. When I learned of the impact that the gut microbiota has on host metabolism, it created an entirely different perspective for me in terms of thinking about how to treat metabolic and nutritional disorders. There are tremendous opportunities in modifying our gut microbiota in concert with dietary interventions in order to modulate our metabolism.

What recent publication from your lab best represents your work, if anyone wants to learn more?

The following work examined how the use of a defined bacterial consortium without urease activity can reduce colonic ammonia level upon inoculation into the gut and ameliorate morbidity and mortality in a murine model of liver disease.

Shen, T.D., Albenberg, L.A., Bittinger, K., et al, Engineering the Gut Microbiota to Treat Hyperammonemia. Journal of Clinical Investigation. 2015 Jul 1;125(7):2841-50.

We spoke with Dr. Shen, instructor of medicine at the University of Pennsylvania and the recipient of the AGA Research Foundation’s 2016 Microbiome Junior Investigator Award, to learn about his passion for gut microbiome research.

How would you sum up your research in one sentence?

My research examines the metabolic interactions between the gut microbiota and the mammalian host, with a particular emphasis on amino acid metabolism and nitrogen flux via the bacterial enzyme urease.

What impact do you hope your research will have on patients?

My hope is that by better understanding the biological mechanisms by which the gut microbiota impacts host metabolism, we can modulate its effects to treat a variety of conditions and diseases including hepatic encephalopathy, inborn errors of metabolism, obesity, malnutrition, etc.

What inspired you to focus your research career on the gut microbiome?

My clinical experience as a gastroenterologist inspired my interest in metabolic and nutritional research. When I learned of the impact that the gut microbiota has on host metabolism, it created an entirely different perspective for me in terms of thinking about how to treat metabolic and nutritional disorders. There are tremendous opportunities in modifying our gut microbiota in concert with dietary interventions in order to modulate our metabolism.

What recent publication from your lab best represents your work, if anyone wants to learn more?

The following work examined how the use of a defined bacterial consortium without urease activity can reduce colonic ammonia level upon inoculation into the gut and ameliorate morbidity and mortality in a murine model of liver disease.

Shen, T.D., Albenberg, L.A., Bittinger, K., et al, Engineering the Gut Microbiota to Treat Hyperammonemia. Journal of Clinical Investigation. 2015 Jul 1;125(7):2841-50.

We spoke with Dr. Shen, instructor of medicine at the University of Pennsylvania and the recipient of the AGA Research Foundation’s 2016 Microbiome Junior Investigator Award, to learn about his passion for gut microbiome research.

How would you sum up your research in one sentence?

My research examines the metabolic interactions between the gut microbiota and the mammalian host, with a particular emphasis on amino acid metabolism and nitrogen flux via the bacterial enzyme urease.

What impact do you hope your research will have on patients?

My hope is that by better understanding the biological mechanisms by which the gut microbiota impacts host metabolism, we can modulate its effects to treat a variety of conditions and diseases including hepatic encephalopathy, inborn errors of metabolism, obesity, malnutrition, etc.

What inspired you to focus your research career on the gut microbiome?

My clinical experience as a gastroenterologist inspired my interest in metabolic and nutritional research. When I learned of the impact that the gut microbiota has on host metabolism, it created an entirely different perspective for me in terms of thinking about how to treat metabolic and nutritional disorders. There are tremendous opportunities in modifying our gut microbiota in concert with dietary interventions in order to modulate our metabolism.

What recent publication from your lab best represents your work, if anyone wants to learn more?

The following work examined how the use of a defined bacterial consortium without urease activity can reduce colonic ammonia level upon inoculation into the gut and ameliorate morbidity and mortality in a murine model of liver disease.

Shen, T.D., Albenberg, L.A., Bittinger, K., et al, Engineering the Gut Microbiota to Treat Hyperammonemia. Journal of Clinical Investigation. 2015 Jul 1;125(7):2841-50.

The call for applications for 2019 Research Scholar Awards (RSA) is now open. An RSA enables young investigators to develop independent and productive research careers by ensuring protected time for research. And our commitment includes supporting the career development of all GI researchers, whether they focus on clinical or basic research. The deadline to apply is Dec. 14, 2018.

The call for applications for 2019 Research Scholar Awards (RSA) is now open. An RSA enables young investigators to develop independent and productive research careers by ensuring protected time for research. And our commitment includes supporting the career development of all GI researchers, whether they focus on clinical or basic research. The deadline to apply is Dec. 14, 2018.

The call for applications for 2019 Research Scholar Awards (RSA) is now open. An RSA enables young investigators to develop independent and productive research careers by ensuring protected time for research. And our commitment includes supporting the career development of all GI researchers, whether they focus on clinical or basic research. The deadline to apply is Dec. 14, 2018.

Editor’s note: It is my pleasure to introduce this new quarterly column in The New Gastroenterologist that will be dedicated to addressing important topics for early-career GIs who are either considering a career or starting a career as an independent GI physician in practice. This column is a collaboration between the AGA’s The New Gastroenterologist and the Digestive Health Physicians Association (DHPA), a national advocacy organization of more than 1,800 gastroenterologists in 79 member practices, which is focused exclusively on policies that promote and protect the high-quality, cost-efficient care provided to patients in the independent GI-practice setting.
Bryson W. Katona, MD, PhD
Editor in Chief, The New Gastroenterologist

Educating and training for your life’s work has likely occupied much of the past 10 years including medical school, residency, and fellowship. When it comes to deciding the next steps, the options can seem daunting.

As a long-standing private practice gastroenterologist, I think it is important for early-career GIs to understand the different private practice options and the new challenges and opportunities that private practitioners are experiencing.

According to recent data, there are approximately 12,500 clinical gastroenterologists divided among private gastroenterology practice models, hospital-based employees, and large multispecialty groups. There are nearly 6,000 private practice gastroenterologists.

Private practice models: What are the options?

A lot has changed since I completed my fellowship training in 1978. But the most dramatic changes have happened in the past decade, including the trend of smaller practices consolidating into larger groups.

Traditionally, physicians and patients have favored individual and very-small-group practices. Patients view small-group practices as highly personalized. They come to appreciate knowing all the physicians and staff in a practice. These long-standing “family type” relationships among patients and providers that often develop in this clinical care setting engenders in both the patient and provider a high level of satisfaction with the type and experience of care provided.

New physicians who are part of a small group practice often have the opportunity to take an earlier and more active role within the leadership of the practice. Small groups typically look to new physicians to function as “innovators” who can introduce into the practice those cutting-edge treatments and procedures learned during fellowship.

In the past decade, however, the trend toward the disappearance of solo and very-small-group practices has accelerated. Today, very small groups face several challenges. Providing all the “necessities” that are now part of today’s medical practice can be daunting. Small-sized practices are less likely to integrate ancillary services (e.g., lab and pathology services, in-office infusions, dietary and weight loss management) that are more typically seen in larger practices. Patients may find this fragmentation of care burdensome when they have to go to several providers for treatment.

The difficulties of implementing and maintaining information technology, EHRs, and patient-engagement tools are often inversely related to group size. In addition, the ability and effectiveness of a group to negotiate with hospital systems and insurance companies can be easier for larger practices, although other local factors will also come into play.

Beyond the administrative aspects of running a small group practice, your views about work-life balance should also be an important consideration when choosing a career path. Understandably, issues of call coverage and time off can be more restrictive in small groups.
 

Is bigger better?

The consolidation seen in hospital systems and multispecialty groups has found its way into single specialty practices. Many urban areas now have GI group practices of 10 or more physicians. There are now approximately 15 groups with 40 or more gastroenterologists, including a few GI practices with 100 or more physicians.

Increasing the size of a practice has obvious potential advantages, including less burdensome on-call requirements and a lower per-physician cost of maintaining and operating the practice. Larger groups often have dedicated software development and IT support staff. Patients are engaged and can connect with their providers through all manner of social media.

Large practice size also can make it possible to enable physicians who may choose to focus on single areas of gastroenterology. This means that a physician who wants to subspecialize in areas such as inflammatory bowel disease, hepatology, woman’s health, and advanced therapeutic endoscopy, would have the requisite large patient base, through internal practice referral, to support subspecialization. Larger groups can also integrate ancillary services into their practice such as pathology, infusion therapy, and nonhospital-based endoscopy services.

However, there can be disadvantages to choosing a larger practice. As in other larger institutions, physicians practicing in larger-sized groups may feel somewhat removed from practice management decisions. It may take several years to become a partner in a large practice – if you are more interested in the opportunity to be involved in practice decisions, a smaller group may be right for you.
 

New trends in practice groups

Physicians are continuously looking for ways to practice effectively and efficiently while expanding the range of services offered (think obesity management). Independent practice physicians are finding it increasingly difficult to grow and manage successful organizations while they care for their patients. Larger practices now typically include areas such as nursing, information technology, human resources, billing, and practice administration. I trained to treat patients, not run a business – there was much I’ve learned along the way. Many schools now offer joint MD/MBA programs. This may help blend the clinical, operational, and business components of practice.

In a newly developing trend, practice groups are exploring strategic partnerships with private equity/venture capital, practice management companies, national ambulatory surgery center companies, and even managed care insurance companies. This creates the opportunity to forge partnerships with these various health care–focused groups, and results in investment in GI practices seeking experienced business leadership and management while remaining independent of a health system. Already well established in dermatology, ophthalmology, and anesthesia, this phenomenon is now beginning in gastroenterology.

There are many things to consider when choosing a career path. Independent practice in gastroenterology continues as a vitally important component of care delivery, and it’s my hope that the new generation of gastroenterologists finds their journey as rewarding and personally satisfying as mine has been.
 

Fred B. Rosenberg, MD, is a board-certified gastroenterologist and the medical director of the North Shore Endoscopy Center in Lake Bluff, Ill., the founding president of Illinois Gastroenterology Group, and immediate past president of DHPA.
 

Editor’s note: It is my pleasure to introduce this new quarterly column in The New Gastroenterologist that will be dedicated to addressing important topics for early-career GIs who are either considering a career or starting a career as an independent GI physician in practice. This column is a collaboration between the AGA’s The New Gastroenterologist and the Digestive Health Physicians Association (DHPA), a national advocacy organization of more than 1,800 gastroenterologists in 79 member practices, which is focused exclusively on policies that promote and protect the high-quality, cost-efficient care provided to patients in the independent GI-practice setting.
Bryson W. Katona, MD, PhD
Editor in Chief, The New Gastroenterologist

Educating and training for your life’s work has likely occupied much of the past 10 years including medical school, residency, and fellowship. When it comes to deciding the next steps, the options can seem daunting.

As a long-standing private practice gastroenterologist, I think it is important for early-career GIs to understand the different private practice options and the new challenges and opportunities that private practitioners are experiencing.

According to recent data, there are approximately 12,500 clinical gastroenterologists divided among private gastroenterology practice models, hospital-based employees, and large multispecialty groups. There are nearly 6,000 private practice gastroenterologists.

Private practice models: What are the options?

A lot has changed since I completed my fellowship training in 1978. But the most dramatic changes have happened in the past decade, including the trend of smaller practices consolidating into larger groups.

Traditionally, physicians and patients have favored individual and very-small-group practices. Patients view small-group practices as highly personalized. They come to appreciate knowing all the physicians and staff in a practice. These long-standing “family type” relationships among patients and providers that often develop in this clinical care setting engenders in both the patient and provider a high level of satisfaction with the type and experience of care provided.

New physicians who are part of a small group practice often have the opportunity to take an earlier and more active role within the leadership of the practice. Small groups typically look to new physicians to function as “innovators” who can introduce into the practice those cutting-edge treatments and procedures learned during fellowship.

In the past decade, however, the trend toward the disappearance of solo and very-small-group practices has accelerated. Today, very small groups face several challenges. Providing all the “necessities” that are now part of today’s medical practice can be daunting. Small-sized practices are less likely to integrate ancillary services (e.g., lab and pathology services, in-office infusions, dietary and weight loss management) that are more typically seen in larger practices. Patients may find this fragmentation of care burdensome when they have to go to several providers for treatment.

The difficulties of implementing and maintaining information technology, EHRs, and patient-engagement tools are often inversely related to group size. In addition, the ability and effectiveness of a group to negotiate with hospital systems and insurance companies can be easier for larger practices, although other local factors will also come into play.

Beyond the administrative aspects of running a small group practice, your views about work-life balance should also be an important consideration when choosing a career path. Understandably, issues of call coverage and time off can be more restrictive in small groups.
 

Is bigger better?

The consolidation seen in hospital systems and multispecialty groups has found its way into single specialty practices. Many urban areas now have GI group practices of 10 or more physicians. There are now approximately 15 groups with 40 or more gastroenterologists, including a few GI practices with 100 or more physicians.

Increasing the size of a practice has obvious potential advantages, including less burdensome on-call requirements and a lower per-physician cost of maintaining and operating the practice. Larger groups often have dedicated software development and IT support staff. Patients are engaged and can connect with their providers through all manner of social media.

Large practice size also can make it possible to enable physicians who may choose to focus on single areas of gastroenterology. This means that a physician who wants to subspecialize in areas such as inflammatory bowel disease, hepatology, woman’s health, and advanced therapeutic endoscopy, would have the requisite large patient base, through internal practice referral, to support subspecialization. Larger groups can also integrate ancillary services into their practice such as pathology, infusion therapy, and nonhospital-based endoscopy services.

However, there can be disadvantages to choosing a larger practice. As in other larger institutions, physicians practicing in larger-sized groups may feel somewhat removed from practice management decisions. It may take several years to become a partner in a large practice – if you are more interested in the opportunity to be involved in practice decisions, a smaller group may be right for you.
 

New trends in practice groups

Physicians are continuously looking for ways to practice effectively and efficiently while expanding the range of services offered (think obesity management). Independent practice physicians are finding it increasingly difficult to grow and manage successful organizations while they care for their patients. Larger practices now typically include areas such as nursing, information technology, human resources, billing, and practice administration. I trained to treat patients, not run a business – there was much I’ve learned along the way. Many schools now offer joint MD/MBA programs. This may help blend the clinical, operational, and business components of practice.

In a newly developing trend, practice groups are exploring strategic partnerships with private equity/venture capital, practice management companies, national ambulatory surgery center companies, and even managed care insurance companies. This creates the opportunity to forge partnerships with these various health care–focused groups, and results in investment in GI practices seeking experienced business leadership and management while remaining independent of a health system. Already well established in dermatology, ophthalmology, and anesthesia, this phenomenon is now beginning in gastroenterology.

There are many things to consider when choosing a career path. Independent practice in gastroenterology continues as a vitally important component of care delivery, and it’s my hope that the new generation of gastroenterologists finds their journey as rewarding and personally satisfying as mine has been.
 

Fred B. Rosenberg, MD, is a board-certified gastroenterologist and the medical director of the North Shore Endoscopy Center in Lake Bluff, Ill., the founding president of Illinois Gastroenterology Group, and immediate past president of DHPA.
 

Editor’s note: It is my pleasure to introduce this new quarterly column in The New Gastroenterologist that will be dedicated to addressing important topics for early-career GIs who are either considering a career or starting a career as an independent GI physician in practice. This column is a collaboration between the AGA’s The New Gastroenterologist and the Digestive Health Physicians Association (DHPA), a national advocacy organization of more than 1,800 gastroenterologists in 79 member practices, which is focused exclusively on policies that promote and protect the high-quality, cost-efficient care provided to patients in the independent GI-practice setting.
Bryson W. Katona, MD, PhD
Editor in Chief, The New Gastroenterologist

Educating and training for your life’s work has likely occupied much of the past 10 years including medical school, residency, and fellowship. When it comes to deciding the next steps, the options can seem daunting.

As a long-standing private practice gastroenterologist, I think it is important for early-career GIs to understand the different private practice options and the new challenges and opportunities that private practitioners are experiencing.

According to recent data, there are approximately 12,500 clinical gastroenterologists divided among private gastroenterology practice models, hospital-based employees, and large multispecialty groups. There are nearly 6,000 private practice gastroenterologists.

Private practice models: What are the options?

A lot has changed since I completed my fellowship training in 1978. But the most dramatic changes have happened in the past decade, including the trend of smaller practices consolidating into larger groups.

Traditionally, physicians and patients have favored individual and very-small-group practices. Patients view small-group practices as highly personalized. They come to appreciate knowing all the physicians and staff in a practice. These long-standing “family type” relationships among patients and providers that often develop in this clinical care setting engenders in both the patient and provider a high level of satisfaction with the type and experience of care provided.

New physicians who are part of a small group practice often have the opportunity to take an earlier and more active role within the leadership of the practice. Small groups typically look to new physicians to function as “innovators” who can introduce into the practice those cutting-edge treatments and procedures learned during fellowship.

In the past decade, however, the trend toward the disappearance of solo and very-small-group practices has accelerated. Today, very small groups face several challenges. Providing all the “necessities” that are now part of today’s medical practice can be daunting. Small-sized practices are less likely to integrate ancillary services (e.g., lab and pathology services, in-office infusions, dietary and weight loss management) that are more typically seen in larger practices. Patients may find this fragmentation of care burdensome when they have to go to several providers for treatment.

The difficulties of implementing and maintaining information technology, EHRs, and patient-engagement tools are often inversely related to group size. In addition, the ability and effectiveness of a group to negotiate with hospital systems and insurance companies can be easier for larger practices, although other local factors will also come into play.

Beyond the administrative aspects of running a small group practice, your views about work-life balance should also be an important consideration when choosing a career path. Understandably, issues of call coverage and time off can be more restrictive in small groups.
 

Is bigger better?

The consolidation seen in hospital systems and multispecialty groups has found its way into single specialty practices. Many urban areas now have GI group practices of 10 or more physicians. There are now approximately 15 groups with 40 or more gastroenterologists, including a few GI practices with 100 or more physicians.

Increasing the size of a practice has obvious potential advantages, including less burdensome on-call requirements and a lower per-physician cost of maintaining and operating the practice. Larger groups often have dedicated software development and IT support staff. Patients are engaged and can connect with their providers through all manner of social media.

Large practice size also can make it possible to enable physicians who may choose to focus on single areas of gastroenterology. This means that a physician who wants to subspecialize in areas such as inflammatory bowel disease, hepatology, woman’s health, and advanced therapeutic endoscopy, would have the requisite large patient base, through internal practice referral, to support subspecialization. Larger groups can also integrate ancillary services into their practice such as pathology, infusion therapy, and nonhospital-based endoscopy services.

However, there can be disadvantages to choosing a larger practice. As in other larger institutions, physicians practicing in larger-sized groups may feel somewhat removed from practice management decisions. It may take several years to become a partner in a large practice – if you are more interested in the opportunity to be involved in practice decisions, a smaller group may be right for you.
 

New trends in practice groups

Physicians are continuously looking for ways to practice effectively and efficiently while expanding the range of services offered (think obesity management). Independent practice physicians are finding it increasingly difficult to grow and manage successful organizations while they care for their patients. Larger practices now typically include areas such as nursing, information technology, human resources, billing, and practice administration. I trained to treat patients, not run a business – there was much I’ve learned along the way. Many schools now offer joint MD/MBA programs. This may help blend the clinical, operational, and business components of practice.

In a newly developing trend, practice groups are exploring strategic partnerships with private equity/venture capital, practice management companies, national ambulatory surgery center companies, and even managed care insurance companies. This creates the opportunity to forge partnerships with these various health care–focused groups, and results in investment in GI practices seeking experienced business leadership and management while remaining independent of a health system. Already well established in dermatology, ophthalmology, and anesthesia, this phenomenon is now beginning in gastroenterology.

There are many things to consider when choosing a career path. Independent practice in gastroenterology continues as a vitally important component of care delivery, and it’s my hope that the new generation of gastroenterologists finds their journey as rewarding and personally satisfying as mine has been.
 

Fred B. Rosenberg, MD, is a board-certified gastroenterologist and the medical director of the North Shore Endoscopy Center in Lake Bluff, Ill., the founding president of Illinois Gastroenterology Group, and immediate past president of DHPA.