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November 2016 Quiz 1
Q1: Answer: B
Rationale: Bile acid diarrhea (BAD) is becoming more widely recognized as a cause of chronic diarrhea. There are four associated types of BAD: Type 1 BAD is associated with ileal dysfunction with impaired reabsorption; type 2 BAD is considered primary or idiopathic BAD and occurs in the absence of ileal or obvious gastrointestinal disease; type 3 BAD is associated with gastrointestinal disorders, such as small intestinal bacterial overgrowth, celiac disease, or chronic pancreatitis; a fourth category of BAD may result from excessive hepatic bile acid synthesis caused by medications. This patient appears to have type 2 BAD; therefore, Answer B is correct. BAD has been shown to account for about one-third of patients with chronic diarrhea or irritable bowel syndrome with diarrhea.
References
1. Camilleri M. Bile acid diarrhea: prevalence, pathogenesis, and therapy. Gut Liver. 2015 May 23;9[3]:332-9.
2. Wedlake L., et al. Systematic review: The prevalence of idiopathic bile acid malabsorption as diagnosed by SeHCAT scanning in patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2009;30:707-17.
Q1: Answer: B
Rationale: Bile acid diarrhea (BAD) is becoming more widely recognized as a cause of chronic diarrhea. There are four associated types of BAD: Type 1 BAD is associated with ileal dysfunction with impaired reabsorption; type 2 BAD is considered primary or idiopathic BAD and occurs in the absence of ileal or obvious gastrointestinal disease; type 3 BAD is associated with gastrointestinal disorders, such as small intestinal bacterial overgrowth, celiac disease, or chronic pancreatitis; a fourth category of BAD may result from excessive hepatic bile acid synthesis caused by medications. This patient appears to have type 2 BAD; therefore, Answer B is correct. BAD has been shown to account for about one-third of patients with chronic diarrhea or irritable bowel syndrome with diarrhea.
References
1. Camilleri M. Bile acid diarrhea: prevalence, pathogenesis, and therapy. Gut Liver. 2015 May 23;9[3]:332-9.
2. Wedlake L., et al. Systematic review: The prevalence of idiopathic bile acid malabsorption as diagnosed by SeHCAT scanning in patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2009;30:707-17.
Q1: Answer: B
Rationale: Bile acid diarrhea (BAD) is becoming more widely recognized as a cause of chronic diarrhea. There are four associated types of BAD: Type 1 BAD is associated with ileal dysfunction with impaired reabsorption; type 2 BAD is considered primary or idiopathic BAD and occurs in the absence of ileal or obvious gastrointestinal disease; type 3 BAD is associated with gastrointestinal disorders, such as small intestinal bacterial overgrowth, celiac disease, or chronic pancreatitis; a fourth category of BAD may result from excessive hepatic bile acid synthesis caused by medications. This patient appears to have type 2 BAD; therefore, Answer B is correct. BAD has been shown to account for about one-third of patients with chronic diarrhea or irritable bowel syndrome with diarrhea.
References
1. Camilleri M. Bile acid diarrhea: prevalence, pathogenesis, and therapy. Gut Liver. 2015 May 23;9[3]:332-9.
2. Wedlake L., et al. Systematic review: The prevalence of idiopathic bile acid malabsorption as diagnosed by SeHCAT scanning in patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2009;30:707-17.
A 44-year-old woman with no significant history presents for an evaluation of an 8-month history of meal-triggered diarrhea. Physical examination is normal. Thyroid function panel, celiac serology, C-reactive protein, lactose breath testing, stool studies for infectious pathogens, enterography imaging, and colonoscopy with biopsies are all negative. Trial of loperamide is not helpful. She is started on a bile acid sequestrant with prompt resolution of symptoms.
ACR annual meeting pediatric track highlights gene sequencing, brain disease
Will gene sequencing be one of the keys to unlocking previously mysterious inflammatory disorders in children?
Yes, according to new research to be presented at the annual meeting of the American College of Rheumatology in Washington. Gene and whole-exome sequencing will change the way these disorders are categorized, diagnosed, and managed, bringing new hope to the children who suffer from these rare, and devastating illnesses.
Program cochairs Anne M. Stevens, MD, and Anthony French, MD, PhD, agree: Gene sequencing is one of the most exciting and potentially practice-changing topics that ACR’s pediatric track will explore.
A session at 11:00 a.m. on Sunday, Nov. 13, is particularly intriguing, said Dr. Stevens of Seattle Children’s Hospital. “Early-Onset Monogenic Inflammatory Diseases” features two speakers.
Hal Hoffman, MD, chief of allergy, immunology and rheumatology in the department of pediatrics at the University of California, San Diego, will speak on inflammasome-associated disorders. He’ll present a case-based lecture, “so pediatric rheumatologists will be able to recognize these diseases, identify the genes underlying them, and make a clear genetic diagnosis,” Dr. Stevens said.
“These two speakers have been successful in identifying specific genes for these illnesses that have led to very specific treatments and, in some cases, complete resolution of symptoms,” Dr. Stevens noted.
“Advances in Clinical Care through Whole Exome Sequencing,” set for 11:00 a.m. on Tuesday, Nov. 15, will explore the practical impact of gene sequencing studies. Alexei A. Grom, MD, of Cincinnati Children’s Hospital, will discuss the practicalities of whole-exome sequencing: when to order it, how to interpret the findings, and how to use the results to help patients.
Jordan S. Orange, MD, PhD, of Baylor College of Medicine, Houston, will discuss his lab’s recent project: whole-exome sequencing of hundreds of pediatric rheumatology patients. “This study hasn’t focused on a specific disease or a specific gene but looked at the entire exome in an unbiased way,” Dr. Stevens said. “So far, they have identified genes associated with inflammatory disease in about 25% of this population.”
The session is meant to be practical as well as academic, Dr. French noted. “In the last few years, these tests have become much more accessible and easier to do in the clinic, not just in a research setting, and we’re going to focus on how to use them to individualize care.”
Dr. Stevens and Dr. French are also excited about the pediatric nephrology track, which kicks off with “What a Pediatric Rheumatologist May Want to Know About the Kidneys” at 8:30 a.m. on Monday, Nov. 14.
Mark M. Mitsnefes, MD, director of clinical and translational research at Cincinnati Children’s Hospital, will focus on treating hypertension in pediatric rheumatology patients. Bradley P. Dixon, MD, director of the nephrology clinical laboratory at Cincinnati Children’s, will review the thrombotic microangiopathies and discuss new treatment options. Stephen Marks, MD, a kidney transplant expert from London, will finish the session with a detailed discussion of lupus nephritis in children, focusing on early diagnosis.
Pediatric autoimmune brain disorders are on tap for a morning session on Tuesday, Nov. 14. Dr. Stevens is particularly looking forward to this session, which begins at 8:30 a.m.
“As pediatric rheumatologists, we are more and more often being asked to consult on new-onset seizures, psychoses, hallucinations, and stroke. It’s quite a challenge to figure out whether these are related to autoimmune disorders.”
The first lecture of the series focuses on the pathogenesis of autoimmune brain disease, and how to make the diagnosis. Russell Dale, MD, of the University of Sydney will talk about therapeutic decision making in these illnesses.
Josep Obrador Dalmau, MD, of the University of Pennsylvania, Philadelphia, will discuss anti–NMDA receptor encephalitis. Hermine I. Brunner, MD, director of rheumatology at Cincinnati Children’s, will close with a diagnostic and therapeutic update of neuropsychiatric systemic lupus erythematosus.
“This is a huge challenge for us,” Dr. Stevens said. “Children with lupus can have obvious central nervous system involvement, but also not-so-obvious involvement, including depression, anxiety, and cognitive difficulties.”
Will gene sequencing be one of the keys to unlocking previously mysterious inflammatory disorders in children?
Yes, according to new research to be presented at the annual meeting of the American College of Rheumatology in Washington. Gene and whole-exome sequencing will change the way these disorders are categorized, diagnosed, and managed, bringing new hope to the children who suffer from these rare, and devastating illnesses.
Program cochairs Anne M. Stevens, MD, and Anthony French, MD, PhD, agree: Gene sequencing is one of the most exciting and potentially practice-changing topics that ACR’s pediatric track will explore.
A session at 11:00 a.m. on Sunday, Nov. 13, is particularly intriguing, said Dr. Stevens of Seattle Children’s Hospital. “Early-Onset Monogenic Inflammatory Diseases” features two speakers.
Hal Hoffman, MD, chief of allergy, immunology and rheumatology in the department of pediatrics at the University of California, San Diego, will speak on inflammasome-associated disorders. He’ll present a case-based lecture, “so pediatric rheumatologists will be able to recognize these diseases, identify the genes underlying them, and make a clear genetic diagnosis,” Dr. Stevens said.
“These two speakers have been successful in identifying specific genes for these illnesses that have led to very specific treatments and, in some cases, complete resolution of symptoms,” Dr. Stevens noted.
“Advances in Clinical Care through Whole Exome Sequencing,” set for 11:00 a.m. on Tuesday, Nov. 15, will explore the practical impact of gene sequencing studies. Alexei A. Grom, MD, of Cincinnati Children’s Hospital, will discuss the practicalities of whole-exome sequencing: when to order it, how to interpret the findings, and how to use the results to help patients.
Jordan S. Orange, MD, PhD, of Baylor College of Medicine, Houston, will discuss his lab’s recent project: whole-exome sequencing of hundreds of pediatric rheumatology patients. “This study hasn’t focused on a specific disease or a specific gene but looked at the entire exome in an unbiased way,” Dr. Stevens said. “So far, they have identified genes associated with inflammatory disease in about 25% of this population.”
The session is meant to be practical as well as academic, Dr. French noted. “In the last few years, these tests have become much more accessible and easier to do in the clinic, not just in a research setting, and we’re going to focus on how to use them to individualize care.”
Dr. Stevens and Dr. French are also excited about the pediatric nephrology track, which kicks off with “What a Pediatric Rheumatologist May Want to Know About the Kidneys” at 8:30 a.m. on Monday, Nov. 14.
Mark M. Mitsnefes, MD, director of clinical and translational research at Cincinnati Children’s Hospital, will focus on treating hypertension in pediatric rheumatology patients. Bradley P. Dixon, MD, director of the nephrology clinical laboratory at Cincinnati Children’s, will review the thrombotic microangiopathies and discuss new treatment options. Stephen Marks, MD, a kidney transplant expert from London, will finish the session with a detailed discussion of lupus nephritis in children, focusing on early diagnosis.
Pediatric autoimmune brain disorders are on tap for a morning session on Tuesday, Nov. 14. Dr. Stevens is particularly looking forward to this session, which begins at 8:30 a.m.
“As pediatric rheumatologists, we are more and more often being asked to consult on new-onset seizures, psychoses, hallucinations, and stroke. It’s quite a challenge to figure out whether these are related to autoimmune disorders.”
The first lecture of the series focuses on the pathogenesis of autoimmune brain disease, and how to make the diagnosis. Russell Dale, MD, of the University of Sydney will talk about therapeutic decision making in these illnesses.
Josep Obrador Dalmau, MD, of the University of Pennsylvania, Philadelphia, will discuss anti–NMDA receptor encephalitis. Hermine I. Brunner, MD, director of rheumatology at Cincinnati Children’s, will close with a diagnostic and therapeutic update of neuropsychiatric systemic lupus erythematosus.
“This is a huge challenge for us,” Dr. Stevens said. “Children with lupus can have obvious central nervous system involvement, but also not-so-obvious involvement, including depression, anxiety, and cognitive difficulties.”
Will gene sequencing be one of the keys to unlocking previously mysterious inflammatory disorders in children?
Yes, according to new research to be presented at the annual meeting of the American College of Rheumatology in Washington. Gene and whole-exome sequencing will change the way these disorders are categorized, diagnosed, and managed, bringing new hope to the children who suffer from these rare, and devastating illnesses.
Program cochairs Anne M. Stevens, MD, and Anthony French, MD, PhD, agree: Gene sequencing is one of the most exciting and potentially practice-changing topics that ACR’s pediatric track will explore.
A session at 11:00 a.m. on Sunday, Nov. 13, is particularly intriguing, said Dr. Stevens of Seattle Children’s Hospital. “Early-Onset Monogenic Inflammatory Diseases” features two speakers.
Hal Hoffman, MD, chief of allergy, immunology and rheumatology in the department of pediatrics at the University of California, San Diego, will speak on inflammasome-associated disorders. He’ll present a case-based lecture, “so pediatric rheumatologists will be able to recognize these diseases, identify the genes underlying them, and make a clear genetic diagnosis,” Dr. Stevens said.
“These two speakers have been successful in identifying specific genes for these illnesses that have led to very specific treatments and, in some cases, complete resolution of symptoms,” Dr. Stevens noted.
“Advances in Clinical Care through Whole Exome Sequencing,” set for 11:00 a.m. on Tuesday, Nov. 15, will explore the practical impact of gene sequencing studies. Alexei A. Grom, MD, of Cincinnati Children’s Hospital, will discuss the practicalities of whole-exome sequencing: when to order it, how to interpret the findings, and how to use the results to help patients.
Jordan S. Orange, MD, PhD, of Baylor College of Medicine, Houston, will discuss his lab’s recent project: whole-exome sequencing of hundreds of pediatric rheumatology patients. “This study hasn’t focused on a specific disease or a specific gene but looked at the entire exome in an unbiased way,” Dr. Stevens said. “So far, they have identified genes associated with inflammatory disease in about 25% of this population.”
The session is meant to be practical as well as academic, Dr. French noted. “In the last few years, these tests have become much more accessible and easier to do in the clinic, not just in a research setting, and we’re going to focus on how to use them to individualize care.”
Dr. Stevens and Dr. French are also excited about the pediatric nephrology track, which kicks off with “What a Pediatric Rheumatologist May Want to Know About the Kidneys” at 8:30 a.m. on Monday, Nov. 14.
Mark M. Mitsnefes, MD, director of clinical and translational research at Cincinnati Children’s Hospital, will focus on treating hypertension in pediatric rheumatology patients. Bradley P. Dixon, MD, director of the nephrology clinical laboratory at Cincinnati Children’s, will review the thrombotic microangiopathies and discuss new treatment options. Stephen Marks, MD, a kidney transplant expert from London, will finish the session with a detailed discussion of lupus nephritis in children, focusing on early diagnosis.
Pediatric autoimmune brain disorders are on tap for a morning session on Tuesday, Nov. 14. Dr. Stevens is particularly looking forward to this session, which begins at 8:30 a.m.
“As pediatric rheumatologists, we are more and more often being asked to consult on new-onset seizures, psychoses, hallucinations, and stroke. It’s quite a challenge to figure out whether these are related to autoimmune disorders.”
The first lecture of the series focuses on the pathogenesis of autoimmune brain disease, and how to make the diagnosis. Russell Dale, MD, of the University of Sydney will talk about therapeutic decision making in these illnesses.
Josep Obrador Dalmau, MD, of the University of Pennsylvania, Philadelphia, will discuss anti–NMDA receptor encephalitis. Hermine I. Brunner, MD, director of rheumatology at Cincinnati Children’s, will close with a diagnostic and therapeutic update of neuropsychiatric systemic lupus erythematosus.
“This is a huge challenge for us,” Dr. Stevens said. “Children with lupus can have obvious central nervous system involvement, but also not-so-obvious involvement, including depression, anxiety, and cognitive difficulties.”
FROM THE ACR ANNUAL MEETING
Session Tackles Merits and Shortcomings of Drug Coated Balloons
Most vascular surgeons have a preferred method for managing femoropopliteal lesions, but drug-coated balloons are emerging as a option for lower extremity lesions.
The Wednesday morning session, “More on Lower Extremity Occlusive Disease: New Developments in Drug Coated Balloons (DCBs); Dealing with Complex Lesions and Trials,” will feature opposing views on how to manage the most severe disease morphology.
In this important session, world renown experts also will discuss the current status and immediate future of drug-coated balloons (DCB) for use on the lower extremity.
“The treatment with DCB is a story of great success. In general, the patency rate is increased and this is with no side effects due to the coating,” said Dr. Gunnar Tepe of Rosenheim Hospital in Rosenheim, Germany. “In the near future treatment with uncoated balloons will be mainly replaced by DCBs.” Dr. Tepe will present a paper on the current status and future prospects of DCBs.
Understanding important technical aspects remains essential to successful outcomes with DCBs, according to Dr. Tepe. “We have to know that treatment with DCBs is not a stand-alone therapy which can be successful in all lesions,” said Dr. Tepe. “If DCBs fail to obtain long-term patency, it is either due to recoil or drug uptake. For recoil, the combination of DCBs and stents is perfect, but for better drug uptake vessel, preparation is needed.”
Dr. Tepe and others will offer a detailed analysis of the potential shortcomings of DCBs, such as in long lesions, and in calcified arteries, and how to overcome them.
“The future of DCBs for use in patients with the potential threat of amputation is under development internationally,” said Dr. Schneider. “Practitioners will leave the session fully updated on the latest data and analysis of the value of DCBs in daily practice, since the most current results from randomized trials, and large registry datasets from the United States and around the world will be presented side by side.”
The presentations include the 3-year results from the international, randomized, controlled IN.PACT SFA Trial that compared the IN.PACT DCB against standard angioplasty. On hand to analyze and discuss the results will be co-principal investigators Dr. Schneider, Dr. Tepe, as well as panelist Dr. John R. Laird of the Vascular Center at the University of California, Davis. Co-moderator and study investigator Dr. Dierk Scheinert, MD, of the Leipzig University Hospital in Germany, will also join the discussion.
“I believe the data will show that DCBs have significantly changed how we practice and that by using them when possible, we can substantially improve what we can offer to patients in terms of long-term durability of the reconstructions we perform for their blocked and damaged arteries,” Dr. Tepe said.
The session will also cover second- and third-generation DCBs that are currently under development.
“As has been the tradition for many years, the VEITH planning committee has been able to bring together the world experts with the most important experience in these topics to educate, debate, inform the broader community,” said Dr. Schneider.
Session 26:
More on Lower Extremity Occlusive Disease: New Developments in Drug Coated Balloons (DCBs); Dealing with Complex Lesions and Trials
Wednesday 10:13 p.m. –12:00 p.m.
Grand Ballroom East, 3rd Floor
Most vascular surgeons have a preferred method for managing femoropopliteal lesions, but drug-coated balloons are emerging as a option for lower extremity lesions.
The Wednesday morning session, “More on Lower Extremity Occlusive Disease: New Developments in Drug Coated Balloons (DCBs); Dealing with Complex Lesions and Trials,” will feature opposing views on how to manage the most severe disease morphology.
In this important session, world renown experts also will discuss the current status and immediate future of drug-coated balloons (DCB) for use on the lower extremity.
“The treatment with DCB is a story of great success. In general, the patency rate is increased and this is with no side effects due to the coating,” said Dr. Gunnar Tepe of Rosenheim Hospital in Rosenheim, Germany. “In the near future treatment with uncoated balloons will be mainly replaced by DCBs.” Dr. Tepe will present a paper on the current status and future prospects of DCBs.
Understanding important technical aspects remains essential to successful outcomes with DCBs, according to Dr. Tepe. “We have to know that treatment with DCBs is not a stand-alone therapy which can be successful in all lesions,” said Dr. Tepe. “If DCBs fail to obtain long-term patency, it is either due to recoil or drug uptake. For recoil, the combination of DCBs and stents is perfect, but for better drug uptake vessel, preparation is needed.”
Dr. Tepe and others will offer a detailed analysis of the potential shortcomings of DCBs, such as in long lesions, and in calcified arteries, and how to overcome them.
“The future of DCBs for use in patients with the potential threat of amputation is under development internationally,” said Dr. Schneider. “Practitioners will leave the session fully updated on the latest data and analysis of the value of DCBs in daily practice, since the most current results from randomized trials, and large registry datasets from the United States and around the world will be presented side by side.”
The presentations include the 3-year results from the international, randomized, controlled IN.PACT SFA Trial that compared the IN.PACT DCB against standard angioplasty. On hand to analyze and discuss the results will be co-principal investigators Dr. Schneider, Dr. Tepe, as well as panelist Dr. John R. Laird of the Vascular Center at the University of California, Davis. Co-moderator and study investigator Dr. Dierk Scheinert, MD, of the Leipzig University Hospital in Germany, will also join the discussion.
“I believe the data will show that DCBs have significantly changed how we practice and that by using them when possible, we can substantially improve what we can offer to patients in terms of long-term durability of the reconstructions we perform for their blocked and damaged arteries,” Dr. Tepe said.
The session will also cover second- and third-generation DCBs that are currently under development.
“As has been the tradition for many years, the VEITH planning committee has been able to bring together the world experts with the most important experience in these topics to educate, debate, inform the broader community,” said Dr. Schneider.
Session 26:
More on Lower Extremity Occlusive Disease: New Developments in Drug Coated Balloons (DCBs); Dealing with Complex Lesions and Trials
Wednesday 10:13 p.m. –12:00 p.m.
Grand Ballroom East, 3rd Floor
Most vascular surgeons have a preferred method for managing femoropopliteal lesions, but drug-coated balloons are emerging as a option for lower extremity lesions.
The Wednesday morning session, “More on Lower Extremity Occlusive Disease: New Developments in Drug Coated Balloons (DCBs); Dealing with Complex Lesions and Trials,” will feature opposing views on how to manage the most severe disease morphology.
In this important session, world renown experts also will discuss the current status and immediate future of drug-coated balloons (DCB) for use on the lower extremity.
“The treatment with DCB is a story of great success. In general, the patency rate is increased and this is with no side effects due to the coating,” said Dr. Gunnar Tepe of Rosenheim Hospital in Rosenheim, Germany. “In the near future treatment with uncoated balloons will be mainly replaced by DCBs.” Dr. Tepe will present a paper on the current status and future prospects of DCBs.
Understanding important technical aspects remains essential to successful outcomes with DCBs, according to Dr. Tepe. “We have to know that treatment with DCBs is not a stand-alone therapy which can be successful in all lesions,” said Dr. Tepe. “If DCBs fail to obtain long-term patency, it is either due to recoil or drug uptake. For recoil, the combination of DCBs and stents is perfect, but for better drug uptake vessel, preparation is needed.”
Dr. Tepe and others will offer a detailed analysis of the potential shortcomings of DCBs, such as in long lesions, and in calcified arteries, and how to overcome them.
“The future of DCBs for use in patients with the potential threat of amputation is under development internationally,” said Dr. Schneider. “Practitioners will leave the session fully updated on the latest data and analysis of the value of DCBs in daily practice, since the most current results from randomized trials, and large registry datasets from the United States and around the world will be presented side by side.”
The presentations include the 3-year results from the international, randomized, controlled IN.PACT SFA Trial that compared the IN.PACT DCB against standard angioplasty. On hand to analyze and discuss the results will be co-principal investigators Dr. Schneider, Dr. Tepe, as well as panelist Dr. John R. Laird of the Vascular Center at the University of California, Davis. Co-moderator and study investigator Dr. Dierk Scheinert, MD, of the Leipzig University Hospital in Germany, will also join the discussion.
“I believe the data will show that DCBs have significantly changed how we practice and that by using them when possible, we can substantially improve what we can offer to patients in terms of long-term durability of the reconstructions we perform for their blocked and damaged arteries,” Dr. Tepe said.
The session will also cover second- and third-generation DCBs that are currently under development.
“As has been the tradition for many years, the VEITH planning committee has been able to bring together the world experts with the most important experience in these topics to educate, debate, inform the broader community,” said Dr. Schneider.
Session 26:
More on Lower Extremity Occlusive Disease: New Developments in Drug Coated Balloons (DCBs); Dealing with Complex Lesions and Trials
Wednesday 10:13 p.m. –12:00 p.m.
Grand Ballroom East, 3rd Floor
Remembering three giants in vascular surgery
This year the VEITHsymposium will be paying tribute to three influential vascular surgeons who are no longer with us: Dr. Allan Callow, Dr. Calvin Ernst, and Dr. John (Jack) Connolly.
Dr. Jerry Goldstone, MD, will have the honor of offering his thoughts on these extraordinary gentlemen during a session on Wednesday morning.
“I knew all three of these men quite well at various stages of my career,” Dr. Goldstone said.
Dr. Allan Callow, who died Dec. 22, 2015, at the age of 99, was considered a pioneer in vascular surgery. His contributions to vascular surgery include helping to perfect carotid endarterectomy.
He served in the U.S. Navy during World War II, retiring with the rank of rear admiral and was “an excellent speaker and had accumulated a very large personal experience with carotid artery disease which he was most recognized for as a clinician.”
Dr. Goldstone noted the different career path that this “great role model” followed.
“The most inspirational thing was his late-in-life switch to a basic science career,” Dr. Goldstone said. “Most of us in academics have our most intense basic research very early in our careers, but Allan’s late research career is inspiring and makes so much sense for a variety of reasons, not the least of which is it avoids the physical demands of clinical research.” Dr. Callow received an NIH RO1 grant at a time when contemporaries were retiring, Dr. Goldstone added.
Dr. Calvin Ernst “was probably best known as an educator, author and very dynamic Society of Vascular Surgery,” Dr. Goldstone said. “During his years on the SVS council, he was very actively involved in just about every activity that affected vascular surgery.”
Describing him as a “true Michigan guy” who was born in Detroit and attended the University of Michigan for undergraduate and medical school and stayed on for his surgery residency and then joined the faculty, Dr. Goldstone also remembered his accomplishments outside of SVS.
“Cal was a renowned surgeon and educator,” Dr. Goldstone recalled. “He was a prolific writer, authoring more than 300 papers and books, the best known probably being the first four editions of ‘Current Therapy in Vascular Surgery’ with Dr. James Stanley. ... He also served as the second co-editor of the Journal of Vascular Surgery and played a very important role in the early success of that journal.”
Dr. Ernst retired from practice in 2001 and died July 7, 2015 at the age of 81.
Dr. Goldstone noted that Dr. John (Jack) Connolly’s interests in cardiac and vascular surgery were broad and that he achieved world-wide fame for his presentations and lectures.
“He had a very prominent international influence and received countless invitations to speak abroad.”
He received fellowships were at the Royal College of Surgeons of England, Ireland and Edinburgh, as well as honorary membership in the Japan Vascular Society and the Vascular Surgical Society of Great Britain and Ireland. He also was honored by the University of California Irvine in 2012 when the institution established the John E. Connolly Endowed Chair in Surgery.
Dr. Goldstone remembered how “Jack” was “always a presence during my surgical training and career. Like Dr. Callow, he was still giving talks and writing papers well into his last years of life. He was very active internationally and was a vascular ambassador. He was charming, friendly, always willing to help younger surgeons and always had a genuine smile when he saw you.”
“For many,” Dr. Goldstone continued, “Jack will also be remembered for his friendship and unselfish support and mentoring.”
Dr. Connolly died Jan. 20, 2016, at the age of 92.
Session 34: Giants No Longer With Us: A Tribute To Allan Callow, Calvin Ernst And John (Jack) Connolly
Wednesday, 10:16 a.m. - 10:21 a.m.
Location: Grand Ballroom West, 3rd Floor
This year the VEITHsymposium will be paying tribute to three influential vascular surgeons who are no longer with us: Dr. Allan Callow, Dr. Calvin Ernst, and Dr. John (Jack) Connolly.
Dr. Jerry Goldstone, MD, will have the honor of offering his thoughts on these extraordinary gentlemen during a session on Wednesday morning.
“I knew all three of these men quite well at various stages of my career,” Dr. Goldstone said.
Dr. Allan Callow, who died Dec. 22, 2015, at the age of 99, was considered a pioneer in vascular surgery. His contributions to vascular surgery include helping to perfect carotid endarterectomy.
He served in the U.S. Navy during World War II, retiring with the rank of rear admiral and was “an excellent speaker and had accumulated a very large personal experience with carotid artery disease which he was most recognized for as a clinician.”
Dr. Goldstone noted the different career path that this “great role model” followed.
“The most inspirational thing was his late-in-life switch to a basic science career,” Dr. Goldstone said. “Most of us in academics have our most intense basic research very early in our careers, but Allan’s late research career is inspiring and makes so much sense for a variety of reasons, not the least of which is it avoids the physical demands of clinical research.” Dr. Callow received an NIH RO1 grant at a time when contemporaries were retiring, Dr. Goldstone added.
Dr. Calvin Ernst “was probably best known as an educator, author and very dynamic Society of Vascular Surgery,” Dr. Goldstone said. “During his years on the SVS council, he was very actively involved in just about every activity that affected vascular surgery.”
Describing him as a “true Michigan guy” who was born in Detroit and attended the University of Michigan for undergraduate and medical school and stayed on for his surgery residency and then joined the faculty, Dr. Goldstone also remembered his accomplishments outside of SVS.
“Cal was a renowned surgeon and educator,” Dr. Goldstone recalled. “He was a prolific writer, authoring more than 300 papers and books, the best known probably being the first four editions of ‘Current Therapy in Vascular Surgery’ with Dr. James Stanley. ... He also served as the second co-editor of the Journal of Vascular Surgery and played a very important role in the early success of that journal.”
Dr. Ernst retired from practice in 2001 and died July 7, 2015 at the age of 81.
Dr. Goldstone noted that Dr. John (Jack) Connolly’s interests in cardiac and vascular surgery were broad and that he achieved world-wide fame for his presentations and lectures.
“He had a very prominent international influence and received countless invitations to speak abroad.”
He received fellowships were at the Royal College of Surgeons of England, Ireland and Edinburgh, as well as honorary membership in the Japan Vascular Society and the Vascular Surgical Society of Great Britain and Ireland. He also was honored by the University of California Irvine in 2012 when the institution established the John E. Connolly Endowed Chair in Surgery.
Dr. Goldstone remembered how “Jack” was “always a presence during my surgical training and career. Like Dr. Callow, he was still giving talks and writing papers well into his last years of life. He was very active internationally and was a vascular ambassador. He was charming, friendly, always willing to help younger surgeons and always had a genuine smile when he saw you.”
“For many,” Dr. Goldstone continued, “Jack will also be remembered for his friendship and unselfish support and mentoring.”
Dr. Connolly died Jan. 20, 2016, at the age of 92.
Session 34: Giants No Longer With Us: A Tribute To Allan Callow, Calvin Ernst And John (Jack) Connolly
Wednesday, 10:16 a.m. - 10:21 a.m.
Location: Grand Ballroom West, 3rd Floor
This year the VEITHsymposium will be paying tribute to three influential vascular surgeons who are no longer with us: Dr. Allan Callow, Dr. Calvin Ernst, and Dr. John (Jack) Connolly.
Dr. Jerry Goldstone, MD, will have the honor of offering his thoughts on these extraordinary gentlemen during a session on Wednesday morning.
“I knew all three of these men quite well at various stages of my career,” Dr. Goldstone said.
Dr. Allan Callow, who died Dec. 22, 2015, at the age of 99, was considered a pioneer in vascular surgery. His contributions to vascular surgery include helping to perfect carotid endarterectomy.
He served in the U.S. Navy during World War II, retiring with the rank of rear admiral and was “an excellent speaker and had accumulated a very large personal experience with carotid artery disease which he was most recognized for as a clinician.”
Dr. Goldstone noted the different career path that this “great role model” followed.
“The most inspirational thing was his late-in-life switch to a basic science career,” Dr. Goldstone said. “Most of us in academics have our most intense basic research very early in our careers, but Allan’s late research career is inspiring and makes so much sense for a variety of reasons, not the least of which is it avoids the physical demands of clinical research.” Dr. Callow received an NIH RO1 grant at a time when contemporaries were retiring, Dr. Goldstone added.
Dr. Calvin Ernst “was probably best known as an educator, author and very dynamic Society of Vascular Surgery,” Dr. Goldstone said. “During his years on the SVS council, he was very actively involved in just about every activity that affected vascular surgery.”
Describing him as a “true Michigan guy” who was born in Detroit and attended the University of Michigan for undergraduate and medical school and stayed on for his surgery residency and then joined the faculty, Dr. Goldstone also remembered his accomplishments outside of SVS.
“Cal was a renowned surgeon and educator,” Dr. Goldstone recalled. “He was a prolific writer, authoring more than 300 papers and books, the best known probably being the first four editions of ‘Current Therapy in Vascular Surgery’ with Dr. James Stanley. ... He also served as the second co-editor of the Journal of Vascular Surgery and played a very important role in the early success of that journal.”
Dr. Ernst retired from practice in 2001 and died July 7, 2015 at the age of 81.
Dr. Goldstone noted that Dr. John (Jack) Connolly’s interests in cardiac and vascular surgery were broad and that he achieved world-wide fame for his presentations and lectures.
“He had a very prominent international influence and received countless invitations to speak abroad.”
He received fellowships were at the Royal College of Surgeons of England, Ireland and Edinburgh, as well as honorary membership in the Japan Vascular Society and the Vascular Surgical Society of Great Britain and Ireland. He also was honored by the University of California Irvine in 2012 when the institution established the John E. Connolly Endowed Chair in Surgery.
Dr. Goldstone remembered how “Jack” was “always a presence during my surgical training and career. Like Dr. Callow, he was still giving talks and writing papers well into his last years of life. He was very active internationally and was a vascular ambassador. He was charming, friendly, always willing to help younger surgeons and always had a genuine smile when he saw you.”
“For many,” Dr. Goldstone continued, “Jack will also be remembered for his friendship and unselfish support and mentoring.”
Dr. Connolly died Jan. 20, 2016, at the age of 92.
Session 34: Giants No Longer With Us: A Tribute To Allan Callow, Calvin Ernst And John (Jack) Connolly
Wednesday, 10:16 a.m. - 10:21 a.m.
Location: Grand Ballroom West, 3rd Floor
Carotid Session to Focus on Asymptomatic Disease, Pivotal Trials
A common clinical challenge encountered by vascular surgeons – what to do with asymptomatic carotid artery disease – will be a main focus of the Tuesday afternoon session, “New Key Developments in the Management of Patients with Carotid Disease.”
“Overall, this session will be a look at mostly asymptomatic carotid stenosis, also with some presentations from experts in the field on how to interpret the long-term results of all these trials and incorporate them into your clinical practice. There should be a lot of excitement about this session in light of recent CMS decisions to reimburse for asymptomatic carotid stenosis” in patients who are at high risk for surgery. “That’s a big leap forward,” said moderator Dr. L. Nelson Hopkins of the State University of New York, Buffalo.
The topic of stenting vs. medical therapy will be the topic of two debates. Dr. Kenneth Rosenfield of Harvard Medical School, Boston, will defend the ACT-1 trial, which found that stenting was noninferior to endarterectomy for up to 5 years in asymptomatic patients with severe stenosis; he was lead investigator. Dr. Anne Abbott of Monash University in Melbourne will counter that medical therapy remains the best option.
In another debate, Dr. Thomas G. Brott of the Mayo Clinic in Jacksonville, Fla., the lead investigator on the CREST trial, will argue that 10-year results prove that stenting and endarterectomy are equivalent for both symptomatic and asymptomatic disease; Dr. J. David Spence, of Western University in London, Ontario, will counter that the data can be interpreted in other ways, and that there is a low rate of occlusion and stroke when high-grade asymptomatic stenosis is treated with best medical therapy.
Dr. Andrew Nicolaides of the Imperial College, London, will also share thoughts on identifying asymptomatic patients who benefit from invasive treatment, and Dr. Bruce Perler of Johns Hopkins University, Baltimore, will argue that endarterectomy is the best option.
The session isn’t limited solely to asymptomatic carotid disease. Dr. James May from the University of Sydney is set to share tips and insights about endovascular repair of saccular aneurysms of the extracranial internal carotid. Recent developments have made this repair safer, but fusiform aneurysms remain a challenge. “There’s going to be information about how to treat these lesions with newer technology,” Dr. Hopkins said.
Session 5:
New Key Developments in the Management of Patients with Carotid Disease
Tuesday,1:00 p.m –2:42 p.m.
Grand Ballroom East, 3rd Floor
A common clinical challenge encountered by vascular surgeons – what to do with asymptomatic carotid artery disease – will be a main focus of the Tuesday afternoon session, “New Key Developments in the Management of Patients with Carotid Disease.”
“Overall, this session will be a look at mostly asymptomatic carotid stenosis, also with some presentations from experts in the field on how to interpret the long-term results of all these trials and incorporate them into your clinical practice. There should be a lot of excitement about this session in light of recent CMS decisions to reimburse for asymptomatic carotid stenosis” in patients who are at high risk for surgery. “That’s a big leap forward,” said moderator Dr. L. Nelson Hopkins of the State University of New York, Buffalo.
The topic of stenting vs. medical therapy will be the topic of two debates. Dr. Kenneth Rosenfield of Harvard Medical School, Boston, will defend the ACT-1 trial, which found that stenting was noninferior to endarterectomy for up to 5 years in asymptomatic patients with severe stenosis; he was lead investigator. Dr. Anne Abbott of Monash University in Melbourne will counter that medical therapy remains the best option.
In another debate, Dr. Thomas G. Brott of the Mayo Clinic in Jacksonville, Fla., the lead investigator on the CREST trial, will argue that 10-year results prove that stenting and endarterectomy are equivalent for both symptomatic and asymptomatic disease; Dr. J. David Spence, of Western University in London, Ontario, will counter that the data can be interpreted in other ways, and that there is a low rate of occlusion and stroke when high-grade asymptomatic stenosis is treated with best medical therapy.
Dr. Andrew Nicolaides of the Imperial College, London, will also share thoughts on identifying asymptomatic patients who benefit from invasive treatment, and Dr. Bruce Perler of Johns Hopkins University, Baltimore, will argue that endarterectomy is the best option.
The session isn’t limited solely to asymptomatic carotid disease. Dr. James May from the University of Sydney is set to share tips and insights about endovascular repair of saccular aneurysms of the extracranial internal carotid. Recent developments have made this repair safer, but fusiform aneurysms remain a challenge. “There’s going to be information about how to treat these lesions with newer technology,” Dr. Hopkins said.
Session 5:
New Key Developments in the Management of Patients with Carotid Disease
Tuesday,1:00 p.m –2:42 p.m.
Grand Ballroom East, 3rd Floor
A common clinical challenge encountered by vascular surgeons – what to do with asymptomatic carotid artery disease – will be a main focus of the Tuesday afternoon session, “New Key Developments in the Management of Patients with Carotid Disease.”
“Overall, this session will be a look at mostly asymptomatic carotid stenosis, also with some presentations from experts in the field on how to interpret the long-term results of all these trials and incorporate them into your clinical practice. There should be a lot of excitement about this session in light of recent CMS decisions to reimburse for asymptomatic carotid stenosis” in patients who are at high risk for surgery. “That’s a big leap forward,” said moderator Dr. L. Nelson Hopkins of the State University of New York, Buffalo.
The topic of stenting vs. medical therapy will be the topic of two debates. Dr. Kenneth Rosenfield of Harvard Medical School, Boston, will defend the ACT-1 trial, which found that stenting was noninferior to endarterectomy for up to 5 years in asymptomatic patients with severe stenosis; he was lead investigator. Dr. Anne Abbott of Monash University in Melbourne will counter that medical therapy remains the best option.
In another debate, Dr. Thomas G. Brott of the Mayo Clinic in Jacksonville, Fla., the lead investigator on the CREST trial, will argue that 10-year results prove that stenting and endarterectomy are equivalent for both symptomatic and asymptomatic disease; Dr. J. David Spence, of Western University in London, Ontario, will counter that the data can be interpreted in other ways, and that there is a low rate of occlusion and stroke when high-grade asymptomatic stenosis is treated with best medical therapy.
Dr. Andrew Nicolaides of the Imperial College, London, will also share thoughts on identifying asymptomatic patients who benefit from invasive treatment, and Dr. Bruce Perler of Johns Hopkins University, Baltimore, will argue that endarterectomy is the best option.
The session isn’t limited solely to asymptomatic carotid disease. Dr. James May from the University of Sydney is set to share tips and insights about endovascular repair of saccular aneurysms of the extracranial internal carotid. Recent developments have made this repair safer, but fusiform aneurysms remain a challenge. “There’s going to be information about how to treat these lesions with newer technology,” Dr. Hopkins said.
Session 5:
New Key Developments in the Management of Patients with Carotid Disease
Tuesday,1:00 p.m –2:42 p.m.
Grand Ballroom East, 3rd Floor
Clinician fatigue not associated with adenoma detection rates in community-based setting
Neither time of day, nor number of procedures performed by the clinician impacted adenoma detection rates in a large community-based setting, a study has shown.
Previously, mixed and scanty data on whether endoscopist fatigue correlates with colonoscopy quality in a community-based setting – where the majority of colonoscopies are performed – brought into question the link between a clinician’s detection rates and patient mortality rates due to interval cancers. Colorectal cancer is the second leading cause of cancer death in the U.S.
The most recent recommended adenoma detection rates – considered benchmarks of colonoscopic quality – are at or above 20% in men and at or above 30% in women, according to the American College of Gastroenterology.
A new study published online in Gastrointestinal Endoscopy, however, indicates that the endoscopists working in a large, integrated, community-based health care system exceeded those quality benchmarks.
Gastroenterologist Alexander T. Lee, MD, and his colleagues identified 126 gastroenterologists in the health system, Kaiser Permanente Northern California, who performed an average of six endoscopy procedures per day – 259,064 in all – between 2010 and 2013, including 76,445 screenings and surveillance colonoscopies. They found that per physician, adenoma detection rates for screening colonoscopy examinations averaged 28.9% and 45.4% for surveillance examinations. By patient gender, the average detection rates per screening were 34.8% for men and 24.0% for women; detection rates per surveillance, the rates were 51.1% for men and 37.8% for women.
After adjusting for confounders, the investigators analyzed each physician’s average adenoma detection rates in association with the time of day each GI procedure was performed, the number of GI procedures performed before each colonoscopy, and the level of complexity of any prior procedures performed at the time of the screening or surveillance colonoscopy. Dr. Lee and his coinvestigators also found that compared with morning examinations, afternoon colonoscopies were not associated with lower adenoma detection for screening examinations, surveillance examinations, or their combination (odds ratio for combination, 0.99; 95% confidence interval, 0.96-1.03). Additionally, neither the number of procedures performed before a given colonoscopy, nor a prior procedure’s complexity, was inversely associated with adenoma detection (OR for detection rates late in the day vs. first procedure of the day, 0.99; 95% CI, 0.94-1.04).
In systems where physicians have larger daily GI procedure loads, there could be an adverse impact on adenoma detection rates, wrote Dr. Lee and his coauthors, but they also noted that quality could similarly be diluted by a lower ratio of procedures to clinician, as well. Whether other demands on a physician’s time, such as other clinical procedures or office tasks, might adversely impact detection rates, Dr. Lee and his colleagues didn’t know because they measured only the colonoscopic screening and surveillance activities. “The reported lack of an association with time of day would argue against this being a substantial factor in [this] study,” they wrote.
“The fact that increased adenoma detection was found only for screening colonoscopy examinations raises the question of whether endoscopists were systematically more vigilant during screening procedures, although the higher observed adenoma detection rates for surveillance examinations suggest otherwise,” the investigators wrote.
None of the investigators listed had any relevant disclosures.
[email protected]
On Twitter @whitneymcknight
The impact of endoscopist fatigue on colonoscopy quality is an understudied topic of great importance. The authors in this study have developed a unique objective measure of fatigue and found no association between fatigue and adenoma detection rates in a large community practice. The lack of an association may reflect the resilience of endoscopists, which is a trait to which we all aspire. One must also consider other explanations for the findings in this study: For one, the measures of fatigue used in this study have not previously been validated, although they have face validity. 
Ziad F. Gellad, MD, MPH , associate professor of medicine in the division of gastroenterology, Duke University Medical Center, Durham, N.C., and Associate Editor on the Board of GI & Hepatology News. He has no conflicts of interest.
The impact of endoscopist fatigue on colonoscopy quality is an understudied topic of great importance. The authors in this study have developed a unique objective measure of fatigue and found no association between fatigue and adenoma detection rates in a large community practice. The lack of an association may reflect the resilience of endoscopists, which is a trait to which we all aspire. One must also consider other explanations for the findings in this study: For one, the measures of fatigue used in this study have not previously been validated, although they have face validity.
Ziad F. Gellad, MD, MPH , associate professor of medicine in the division of gastroenterology, Duke University Medical Center, Durham, N.C., and Associate Editor on the Board of GI & Hepatology News. He has no conflicts of interest.
The impact of endoscopist fatigue on colonoscopy quality is an understudied topic of great importance. The authors in this study have developed a unique objective measure of fatigue and found no association between fatigue and adenoma detection rates in a large community practice. The lack of an association may reflect the resilience of endoscopists, which is a trait to which we all aspire. One must also consider other explanations for the findings in this study: For one, the measures of fatigue used in this study have not previously been validated, although they have face validity.
Ziad F. Gellad, MD, MPH , associate professor of medicine in the division of gastroenterology, Duke University Medical Center, Durham, N.C., and Associate Editor on the Board of GI & Hepatology News. He has no conflicts of interest.
Neither time of day, nor number of procedures performed by the clinician impacted adenoma detection rates in a large community-based setting, a study has shown.
Previously, mixed and scanty data on whether endoscopist fatigue correlates with colonoscopy quality in a community-based setting – where the majority of colonoscopies are performed – brought into question the link between a clinician’s detection rates and patient mortality rates due to interval cancers. Colorectal cancer is the second leading cause of cancer death in the U.S.
The most recent recommended adenoma detection rates – considered benchmarks of colonoscopic quality – are at or above 20% in men and at or above 30% in women, according to the American College of Gastroenterology.
A new study published online in Gastrointestinal Endoscopy, however, indicates that the endoscopists working in a large, integrated, community-based health care system exceeded those quality benchmarks.
Gastroenterologist Alexander T. Lee, MD, and his colleagues identified 126 gastroenterologists in the health system, Kaiser Permanente Northern California, who performed an average of six endoscopy procedures per day – 259,064 in all – between 2010 and 2013, including 76,445 screenings and surveillance colonoscopies. They found that per physician, adenoma detection rates for screening colonoscopy examinations averaged 28.9% and 45.4% for surveillance examinations. By patient gender, the average detection rates per screening were 34.8% for men and 24.0% for women; detection rates per surveillance, the rates were 51.1% for men and 37.8% for women.
After adjusting for confounders, the investigators analyzed each physician’s average adenoma detection rates in association with the time of day each GI procedure was performed, the number of GI procedures performed before each colonoscopy, and the level of complexity of any prior procedures performed at the time of the screening or surveillance colonoscopy. Dr. Lee and his coinvestigators also found that compared with morning examinations, afternoon colonoscopies were not associated with lower adenoma detection for screening examinations, surveillance examinations, or their combination (odds ratio for combination, 0.99; 95% confidence interval, 0.96-1.03). Additionally, neither the number of procedures performed before a given colonoscopy, nor a prior procedure’s complexity, was inversely associated with adenoma detection (OR for detection rates late in the day vs. first procedure of the day, 0.99; 95% CI, 0.94-1.04).
In systems where physicians have larger daily GI procedure loads, there could be an adverse impact on adenoma detection rates, wrote Dr. Lee and his coauthors, but they also noted that quality could similarly be diluted by a lower ratio of procedures to clinician, as well. Whether other demands on a physician’s time, such as other clinical procedures or office tasks, might adversely impact detection rates, Dr. Lee and his colleagues didn’t know because they measured only the colonoscopic screening and surveillance activities. “The reported lack of an association with time of day would argue against this being a substantial factor in [this] study,” they wrote.
“The fact that increased adenoma detection was found only for screening colonoscopy examinations raises the question of whether endoscopists were systematically more vigilant during screening procedures, although the higher observed adenoma detection rates for surveillance examinations suggest otherwise,” the investigators wrote.
None of the investigators listed had any relevant disclosures.
[email protected]
On Twitter @whitneymcknight
Neither time of day, nor number of procedures performed by the clinician impacted adenoma detection rates in a large community-based setting, a study has shown.
Previously, mixed and scanty data on whether endoscopist fatigue correlates with colonoscopy quality in a community-based setting – where the majority of colonoscopies are performed – brought into question the link between a clinician’s detection rates and patient mortality rates due to interval cancers. Colorectal cancer is the second leading cause of cancer death in the U.S.
The most recent recommended adenoma detection rates – considered benchmarks of colonoscopic quality – are at or above 20% in men and at or above 30% in women, according to the American College of Gastroenterology.
A new study published online in Gastrointestinal Endoscopy, however, indicates that the endoscopists working in a large, integrated, community-based health care system exceeded those quality benchmarks.
Gastroenterologist Alexander T. Lee, MD, and his colleagues identified 126 gastroenterologists in the health system, Kaiser Permanente Northern California, who performed an average of six endoscopy procedures per day – 259,064 in all – between 2010 and 2013, including 76,445 screenings and surveillance colonoscopies. They found that per physician, adenoma detection rates for screening colonoscopy examinations averaged 28.9% and 45.4% for surveillance examinations. By patient gender, the average detection rates per screening were 34.8% for men and 24.0% for women; detection rates per surveillance, the rates were 51.1% for men and 37.8% for women.
After adjusting for confounders, the investigators analyzed each physician’s average adenoma detection rates in association with the time of day each GI procedure was performed, the number of GI procedures performed before each colonoscopy, and the level of complexity of any prior procedures performed at the time of the screening or surveillance colonoscopy. Dr. Lee and his coinvestigators also found that compared with morning examinations, afternoon colonoscopies were not associated with lower adenoma detection for screening examinations, surveillance examinations, or their combination (odds ratio for combination, 0.99; 95% confidence interval, 0.96-1.03). Additionally, neither the number of procedures performed before a given colonoscopy, nor a prior procedure’s complexity, was inversely associated with adenoma detection (OR for detection rates late in the day vs. first procedure of the day, 0.99; 95% CI, 0.94-1.04).
In systems where physicians have larger daily GI procedure loads, there could be an adverse impact on adenoma detection rates, wrote Dr. Lee and his coauthors, but they also noted that quality could similarly be diluted by a lower ratio of procedures to clinician, as well. Whether other demands on a physician’s time, such as other clinical procedures or office tasks, might adversely impact detection rates, Dr. Lee and his colleagues didn’t know because they measured only the colonoscopic screening and surveillance activities. “The reported lack of an association with time of day would argue against this being a substantial factor in [this] study,” they wrote.
“The fact that increased adenoma detection was found only for screening colonoscopy examinations raises the question of whether endoscopists were systematically more vigilant during screening procedures, although the higher observed adenoma detection rates for surveillance examinations suggest otherwise,” the investigators wrote.
None of the investigators listed had any relevant disclosures.
[email protected]
On Twitter @whitneymcknight
FROM GASTROINTESTINAL ENDOSCOPY
Key clinical point:
Major finding: Compared with morning examinations, afternoon colonoscopies were not associated with lower adenoma detection rates (OR for detection rates late in the day vs. first procedure of the day, 0.99; 95% CI, 0.94-1.04).
Data source: Retrospective analysis of 126 community-based gastroenterologists who performed an average of six GI procedures daily between 2010 and 2013.
Disclosures: None of the investigators listed had any relevant disclosures.
Biosimilars face barriers to broader acceptance
BOSTON – For rheumatologists, the primary selling points of biosimilar agents are their presumed efficacy and safety, and their promised cost savings, compared with the reference product, an original biologic agent.
But market forces, patient worries, and provider concerns threaten to file off at least some of biosimilars’ presumed competitive edge, says a rheumatologist involved in the development of biosimilars to treat rheumatic diseases.
“The availability of lower-priced biosimilars, if they’re truly lower priced, should decrease the cost of treating patients; if they’re not lower cost, then this advantage is not holding true,” said Jonathan Kay, MD, professor of medicine at UMass Memorial Medical Center in Worcester.
But the world is far from perfect, and there are a host of educational, financial, and societal barriers to more widespread acceptance of these agents, he said.
Misperceptions
A common concern among patients and uninformed providers is that biosimilars are the same as biomimics – cheap, usually foreign-made knockoffs of existing drugs that have not undergone regulatory scrutiny and may be neither effective nor safe.
“Biomimics scare patients and scare physicians,” he said, “and misunderstanding of the regulatory approval process, or lack of understanding of the regulatory review or approval process, also intimidates individuals about biosimilars.”
Acceptance of biosimilars is also hampered by a lack of long-term, real-world efficacy and safety data. This is due, in part, to the “inverted pyramid” nature of the biosimilar development and approval process, which starts with myriad analytical, chemical, and functional characterization studies; nonclinical studies; and pharmacokinetic and pharmacodynamic analyses, but only one or two clinical trials. In contrast, the development process for innovator biologics starts with molecular characterization, then moves through the traditional drug development stages of laboratory and preclinical studies, phase I and II trials, and finally phase III registration trials and post-marketing studies.
Because most of the drug development for biosimilars happens behind the scenes, patients and their physicians are often leery about the finished product, no matter how rigorously it was developed. Similarly, there is a paucity of data on long-term immunogenicity of biosimilars, Dr. Kay noted.
Extrapolating about extrapolation
The idea of extrapolation of indications for biosimilars is also an alien concept to many. Simply put, if a reference product is approved for rheumatoid arthritis and has additional indications for treatment of psoriatic arthritis, the approved biosimilar to the original can be extrapolated to be effective against the same indications, even if it has only been tested against one of the indications.
“We have a tremendous amount of clinical experience not only in randomized, controlled clinical trials but also years of marketing experience showing that the reference product is effective and safe for each of the indications for which it’s been approved, and knowing that the biosimilar is essentially like another [manufacturing] run of the reference product allows us to extrapolate indications. But until you become comfortable with accepting that concept, it is certainly a barrier to biosimilars,” he said.
Patients are also scared by the issue of interchangeability, which would allow pharmacists to substitute one product for another without approval of either the patient or the prescribing physician. However, there are currently no biosimilar agents approved as interchangeable by the Food and Drug Administration.
What cost savings?
In the United States, the price of marketed biosimilars has been only 15% lower than that of the reference product, Dr. Kay noted, and multiple discount programs and rebates offered by marketers of the reference product make it difficult to figure out the actual costs of the drugs to payers and whether biosimilars are actually any cheaper.
Additionally, clinicians may be reluctant to adopt biosimilars because of a Centers for Medicare & Medicaid Services billing quirk that currently offers only a single “J” code with a blended reimbursement for all biosimilar agents of a reference product, regardless of cost differences.
Nordic competition model
Dr. Kay pointed to the Norwegian Tender System as a model for using biosimilars to drive down drug costs.
The Norwegian Drug Procurement Cooperation (LIS) annually procures drugs for all publicly funded hospitals, which ensures that prices offered to hospitals for patent-protected medicines are lower than those offered for distribution to wholesalers or pharmacies. Under this system, cost is the driving factor, assuming that drugs in a similar class have similar efficacy and safety, he said.
In 2015, when Norway was purchasing infliximab, it chose Remsima, the biosimilar, over the reference product Remicade, resulting in a 69% cost saving.
The potential interchangeability of Remsima and Remicade in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, and chronic plaque psoriasis is currently being explored in the NOR-SWITCH trial.
Dr. Kay disclosed receiving institutional grants from AbbVie, Genentech, Roche Laboratories, and UCB, and serving as a consultant for those companies.
BOSTON – For rheumatologists, the primary selling points of biosimilar agents are their presumed efficacy and safety, and their promised cost savings, compared with the reference product, an original biologic agent.
But market forces, patient worries, and provider concerns threaten to file off at least some of biosimilars’ presumed competitive edge, says a rheumatologist involved in the development of biosimilars to treat rheumatic diseases.
“The availability of lower-priced biosimilars, if they’re truly lower priced, should decrease the cost of treating patients; if they’re not lower cost, then this advantage is not holding true,” said Jonathan Kay, MD, professor of medicine at UMass Memorial Medical Center in Worcester.
But the world is far from perfect, and there are a host of educational, financial, and societal barriers to more widespread acceptance of these agents, he said.
Misperceptions
A common concern among patients and uninformed providers is that biosimilars are the same as biomimics – cheap, usually foreign-made knockoffs of existing drugs that have not undergone regulatory scrutiny and may be neither effective nor safe.
“Biomimics scare patients and scare physicians,” he said, “and misunderstanding of the regulatory approval process, or lack of understanding of the regulatory review or approval process, also intimidates individuals about biosimilars.”
Acceptance of biosimilars is also hampered by a lack of long-term, real-world efficacy and safety data. This is due, in part, to the “inverted pyramid” nature of the biosimilar development and approval process, which starts with myriad analytical, chemical, and functional characterization studies; nonclinical studies; and pharmacokinetic and pharmacodynamic analyses, but only one or two clinical trials. In contrast, the development process for innovator biologics starts with molecular characterization, then moves through the traditional drug development stages of laboratory and preclinical studies, phase I and II trials, and finally phase III registration trials and post-marketing studies.
Because most of the drug development for biosimilars happens behind the scenes, patients and their physicians are often leery about the finished product, no matter how rigorously it was developed. Similarly, there is a paucity of data on long-term immunogenicity of biosimilars, Dr. Kay noted.
Extrapolating about extrapolation
The idea of extrapolation of indications for biosimilars is also an alien concept to many. Simply put, if a reference product is approved for rheumatoid arthritis and has additional indications for treatment of psoriatic arthritis, the approved biosimilar to the original can be extrapolated to be effective against the same indications, even if it has only been tested against one of the indications.
“We have a tremendous amount of clinical experience not only in randomized, controlled clinical trials but also years of marketing experience showing that the reference product is effective and safe for each of the indications for which it’s been approved, and knowing that the biosimilar is essentially like another [manufacturing] run of the reference product allows us to extrapolate indications. But until you become comfortable with accepting that concept, it is certainly a barrier to biosimilars,” he said.
Patients are also scared by the issue of interchangeability, which would allow pharmacists to substitute one product for another without approval of either the patient or the prescribing physician. However, there are currently no biosimilar agents approved as interchangeable by the Food and Drug Administration.
What cost savings?
In the United States, the price of marketed biosimilars has been only 15% lower than that of the reference product, Dr. Kay noted, and multiple discount programs and rebates offered by marketers of the reference product make it difficult to figure out the actual costs of the drugs to payers and whether biosimilars are actually any cheaper.
Additionally, clinicians may be reluctant to adopt biosimilars because of a Centers for Medicare & Medicaid Services billing quirk that currently offers only a single “J” code with a blended reimbursement for all biosimilar agents of a reference product, regardless of cost differences.
Nordic competition model
Dr. Kay pointed to the Norwegian Tender System as a model for using biosimilars to drive down drug costs.
The Norwegian Drug Procurement Cooperation (LIS) annually procures drugs for all publicly funded hospitals, which ensures that prices offered to hospitals for patent-protected medicines are lower than those offered for distribution to wholesalers or pharmacies. Under this system, cost is the driving factor, assuming that drugs in a similar class have similar efficacy and safety, he said.
In 2015, when Norway was purchasing infliximab, it chose Remsima, the biosimilar, over the reference product Remicade, resulting in a 69% cost saving.
The potential interchangeability of Remsima and Remicade in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, and chronic plaque psoriasis is currently being explored in the NOR-SWITCH trial.
Dr. Kay disclosed receiving institutional grants from AbbVie, Genentech, Roche Laboratories, and UCB, and serving as a consultant for those companies.
BOSTON – For rheumatologists, the primary selling points of biosimilar agents are their presumed efficacy and safety, and their promised cost savings, compared with the reference product, an original biologic agent.
But market forces, patient worries, and provider concerns threaten to file off at least some of biosimilars’ presumed competitive edge, says a rheumatologist involved in the development of biosimilars to treat rheumatic diseases.
“The availability of lower-priced biosimilars, if they’re truly lower priced, should decrease the cost of treating patients; if they’re not lower cost, then this advantage is not holding true,” said Jonathan Kay, MD, professor of medicine at UMass Memorial Medical Center in Worcester.
But the world is far from perfect, and there are a host of educational, financial, and societal barriers to more widespread acceptance of these agents, he said.
Misperceptions
A common concern among patients and uninformed providers is that biosimilars are the same as biomimics – cheap, usually foreign-made knockoffs of existing drugs that have not undergone regulatory scrutiny and may be neither effective nor safe.
“Biomimics scare patients and scare physicians,” he said, “and misunderstanding of the regulatory approval process, or lack of understanding of the regulatory review or approval process, also intimidates individuals about biosimilars.”
Acceptance of biosimilars is also hampered by a lack of long-term, real-world efficacy and safety data. This is due, in part, to the “inverted pyramid” nature of the biosimilar development and approval process, which starts with myriad analytical, chemical, and functional characterization studies; nonclinical studies; and pharmacokinetic and pharmacodynamic analyses, but only one or two clinical trials. In contrast, the development process for innovator biologics starts with molecular characterization, then moves through the traditional drug development stages of laboratory and preclinical studies, phase I and II trials, and finally phase III registration trials and post-marketing studies.
Because most of the drug development for biosimilars happens behind the scenes, patients and their physicians are often leery about the finished product, no matter how rigorously it was developed. Similarly, there is a paucity of data on long-term immunogenicity of biosimilars, Dr. Kay noted.
Extrapolating about extrapolation
The idea of extrapolation of indications for biosimilars is also an alien concept to many. Simply put, if a reference product is approved for rheumatoid arthritis and has additional indications for treatment of psoriatic arthritis, the approved biosimilar to the original can be extrapolated to be effective against the same indications, even if it has only been tested against one of the indications.
“We have a tremendous amount of clinical experience not only in randomized, controlled clinical trials but also years of marketing experience showing that the reference product is effective and safe for each of the indications for which it’s been approved, and knowing that the biosimilar is essentially like another [manufacturing] run of the reference product allows us to extrapolate indications. But until you become comfortable with accepting that concept, it is certainly a barrier to biosimilars,” he said.
Patients are also scared by the issue of interchangeability, which would allow pharmacists to substitute one product for another without approval of either the patient or the prescribing physician. However, there are currently no biosimilar agents approved as interchangeable by the Food and Drug Administration.
What cost savings?
In the United States, the price of marketed biosimilars has been only 15% lower than that of the reference product, Dr. Kay noted, and multiple discount programs and rebates offered by marketers of the reference product make it difficult to figure out the actual costs of the drugs to payers and whether biosimilars are actually any cheaper.
Additionally, clinicians may be reluctant to adopt biosimilars because of a Centers for Medicare & Medicaid Services billing quirk that currently offers only a single “J” code with a blended reimbursement for all biosimilar agents of a reference product, regardless of cost differences.
Nordic competition model
Dr. Kay pointed to the Norwegian Tender System as a model for using biosimilars to drive down drug costs.
The Norwegian Drug Procurement Cooperation (LIS) annually procures drugs for all publicly funded hospitals, which ensures that prices offered to hospitals for patent-protected medicines are lower than those offered for distribution to wholesalers or pharmacies. Under this system, cost is the driving factor, assuming that drugs in a similar class have similar efficacy and safety, he said.
In 2015, when Norway was purchasing infliximab, it chose Remsima, the biosimilar, over the reference product Remicade, resulting in a 69% cost saving.
The potential interchangeability of Remsima and Remicade in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, and chronic plaque psoriasis is currently being explored in the NOR-SWITCH trial.
Dr. Kay disclosed receiving institutional grants from AbbVie, Genentech, Roche Laboratories, and UCB, and serving as a consultant for those companies.
EXPERT ANALYSIS FROM A BIOSIMILARS IN RHEUMATOLOGY SYMPOSIUM
Blood assay rapidly identifies lung cancer mutations
LOS ANGELES – A newer blood test (GeneStrat from Biodesix) identified genetic mutations in lung tumors in about 24 hours, allowing for an early start of mutation-specific chemotherapy, in an investigation from Gundersen Health System in La Crosse, Wis.
Interventional pulmonologists drew blood samples when they performed biopsies on 84 patients with highly suspicious lung nodules and submitted both blood and tissue for mutation analysis. The blood was analyzed by Biodesix, the maker of GeneStrat, a commercially available digital droplet polymerase change reaction assay launched in 2015. The company sent the results back in an average of 24.1 hours, and all within 72 hours. The mutation results from tissue analysis took 2-3 weeks.
Fifteen patients (18%) had actionable epidermal growth factor receptor, anaplastic lymphoma kinase, or K-Ras protein gene mutations, and were candidates for targeted therapy. Compared with tissue testing, the blood assay had a sensitivity of 88% and a specificity of 99%. The tissue testing picked up two mutations missed by blood testing. One of the two mutations is rare and was not included in the blood assay. Meanwhile, the assay caught a mutation missed on tissue analysis.
She and her colleagues are now routinely using GeneStrat to guide initial lung cancer therapy. “The turnaround time is fantastic. It allows us to have [the mutation status] when oncologists meet with patients for the very first time,” she said.
It “definitely” makes a difference. “If you have an actionable mutation and there’s a targeted chemotherapy” – such as erlotinib (Tarceva) for epidermal growth factor receptor mutation patients – it can be started right out of the gate. “Time to treatment is very important,” not just psychologically for patients but also for them to have the best chance against the tumor. The sooner “we can start a targeted therapy,” the better outcomes are likely to be, Dr. Mattingley said.
When mutation status is delayed, patients might be started “on the wrong therapy upfront, and it’s really hard to back up and start over again,” she said.
“Once we give patients a diagnosis of lung cancer, the next thing they should hear right away is how we are going to attack it. We felt strongly [that there was a] need to look at this to see if we could truly expedite the time from diagnosis to treatment. We believe our patients should have no sleepless nights,” Dr. Mattingley said.
There’s also usually not much tissue left after genetic work-up to send into a clinical trial. Using blood to identify mutations “may allow us to conserve our tissue block for future trials, but still get the genetic information we need to start treatment plans for our patients,” she said.
There was no company funding for the work, but Dr. Mattingley is a speaker for GeneStrat’s maker, Biodesix.
The results of this study are very promising. The high concordance between liquid biopsies and tissue biopsies as well as the short turn-around time for the results of the liquid biopsies makes a big difference in terms of getting patients started on appropriate therapy sooner rather than later. We need additional studies to find out if liquid biopsies will be good for detection of other molecular alterations such as ROS-1 and EGFR acquired mutation T790M.
The results of this study are very promising. The high concordance between liquid biopsies and tissue biopsies as well as the short turn-around time for the results of the liquid biopsies makes a big difference in terms of getting patients started on appropriate therapy sooner rather than later. We need additional studies to find out if liquid biopsies will be good for detection of other molecular alterations such as ROS-1 and EGFR acquired mutation T790M.
The results of this study are very promising. The high concordance between liquid biopsies and tissue biopsies as well as the short turn-around time for the results of the liquid biopsies makes a big difference in terms of getting patients started on appropriate therapy sooner rather than later. We need additional studies to find out if liquid biopsies will be good for detection of other molecular alterations such as ROS-1 and EGFR acquired mutation T790M.
LOS ANGELES – A newer blood test (GeneStrat from Biodesix) identified genetic mutations in lung tumors in about 24 hours, allowing for an early start of mutation-specific chemotherapy, in an investigation from Gundersen Health System in La Crosse, Wis.
Interventional pulmonologists drew blood samples when they performed biopsies on 84 patients with highly suspicious lung nodules and submitted both blood and tissue for mutation analysis. The blood was analyzed by Biodesix, the maker of GeneStrat, a commercially available digital droplet polymerase change reaction assay launched in 2015. The company sent the results back in an average of 24.1 hours, and all within 72 hours. The mutation results from tissue analysis took 2-3 weeks.
Fifteen patients (18%) had actionable epidermal growth factor receptor, anaplastic lymphoma kinase, or K-Ras protein gene mutations, and were candidates for targeted therapy. Compared with tissue testing, the blood assay had a sensitivity of 88% and a specificity of 99%. The tissue testing picked up two mutations missed by blood testing. One of the two mutations is rare and was not included in the blood assay. Meanwhile, the assay caught a mutation missed on tissue analysis.
She and her colleagues are now routinely using GeneStrat to guide initial lung cancer therapy. “The turnaround time is fantastic. It allows us to have [the mutation status] when oncologists meet with patients for the very first time,” she said.
It “definitely” makes a difference. “If you have an actionable mutation and there’s a targeted chemotherapy” – such as erlotinib (Tarceva) for epidermal growth factor receptor mutation patients – it can be started right out of the gate. “Time to treatment is very important,” not just psychologically for patients but also for them to have the best chance against the tumor. The sooner “we can start a targeted therapy,” the better outcomes are likely to be, Dr. Mattingley said.
When mutation status is delayed, patients might be started “on the wrong therapy upfront, and it’s really hard to back up and start over again,” she said.
“Once we give patients a diagnosis of lung cancer, the next thing they should hear right away is how we are going to attack it. We felt strongly [that there was a] need to look at this to see if we could truly expedite the time from diagnosis to treatment. We believe our patients should have no sleepless nights,” Dr. Mattingley said.
There’s also usually not much tissue left after genetic work-up to send into a clinical trial. Using blood to identify mutations “may allow us to conserve our tissue block for future trials, but still get the genetic information we need to start treatment plans for our patients,” she said.
There was no company funding for the work, but Dr. Mattingley is a speaker for GeneStrat’s maker, Biodesix.
LOS ANGELES – A newer blood test (GeneStrat from Biodesix) identified genetic mutations in lung tumors in about 24 hours, allowing for an early start of mutation-specific chemotherapy, in an investigation from Gundersen Health System in La Crosse, Wis.
Interventional pulmonologists drew blood samples when they performed biopsies on 84 patients with highly suspicious lung nodules and submitted both blood and tissue for mutation analysis. The blood was analyzed by Biodesix, the maker of GeneStrat, a commercially available digital droplet polymerase change reaction assay launched in 2015. The company sent the results back in an average of 24.1 hours, and all within 72 hours. The mutation results from tissue analysis took 2-3 weeks.
Fifteen patients (18%) had actionable epidermal growth factor receptor, anaplastic lymphoma kinase, or K-Ras protein gene mutations, and were candidates for targeted therapy. Compared with tissue testing, the blood assay had a sensitivity of 88% and a specificity of 99%. The tissue testing picked up two mutations missed by blood testing. One of the two mutations is rare and was not included in the blood assay. Meanwhile, the assay caught a mutation missed on tissue analysis.
She and her colleagues are now routinely using GeneStrat to guide initial lung cancer therapy. “The turnaround time is fantastic. It allows us to have [the mutation status] when oncologists meet with patients for the very first time,” she said.
It “definitely” makes a difference. “If you have an actionable mutation and there’s a targeted chemotherapy” – such as erlotinib (Tarceva) for epidermal growth factor receptor mutation patients – it can be started right out of the gate. “Time to treatment is very important,” not just psychologically for patients but also for them to have the best chance against the tumor. The sooner “we can start a targeted therapy,” the better outcomes are likely to be, Dr. Mattingley said.
When mutation status is delayed, patients might be started “on the wrong therapy upfront, and it’s really hard to back up and start over again,” she said.
“Once we give patients a diagnosis of lung cancer, the next thing they should hear right away is how we are going to attack it. We felt strongly [that there was a] need to look at this to see if we could truly expedite the time from diagnosis to treatment. We believe our patients should have no sleepless nights,” Dr. Mattingley said.
There’s also usually not much tissue left after genetic work-up to send into a clinical trial. Using blood to identify mutations “may allow us to conserve our tissue block for future trials, but still get the genetic information we need to start treatment plans for our patients,” she said.
There was no company funding for the work, but Dr. Mattingley is a speaker for GeneStrat’s maker, Biodesix.
AT CHEST 2016
Key clinical point:
Major finding: Compared with tissue testing, the blood assay had a sensitivity of 88% and a specificity of 99%.
Data source: Eighty-four patients with highly suspicious lung nodules.
Disclosures: There was no company funding for the work, but the presenter is a paid speaker for GeneStrat’s maker, Biodesix.
Long-Term Mortality in Nondiabetic Patients Favors Coronary Artery Bypass Over Intervention with Drug-Eluting Stents
Clinical Question: Is there a mortality difference in nondiabetic patients with multivessel coronary artery disease (CAD) treated with coronary artery bypass graft (CABG) versus percutaneous coronary intervention (PCI)?
Background: Randomized clinical trials have shown a mortality benefit of CABG over PCI with drug-eluting stents (DES) for diabetic patients. The best strategy for nondiabetics, however, has not been well established.
Study Design: Pooled individual patient data from two large randomized clinical trials.
Setting: Multicenter, multinational (Europe, United States, Asia).
Synopsis: Excluding patients with left main disease, a total of 1,275 nondiabetic patients with two- or three-vessel CAD were analyzed. After median follow-up of 61 months, the CABG group had significantly fewer deaths from any cause (hazard ratio [HR], 0.65; 95% CI, 0.43–0.98; P=0.039) as well as fewer deaths from cardiac causes (HR, 0.41; 95% CI, 0.25–0.78; P=0.005) when compared to PCI with DES. The benefit was primarily seen at five-year follow-up in patients with intermediate to severe disease, with a nonsignificant difference detected in patients with less severe disease.
Despite the increasing popularity of DES, this study suggests that for nondiabetic patients with CAD, there is a mortality benefit at five years favoring CABG over PCI with DES. However, in this study stents used for PCI included both older and newer generation DES; a study using only newer DES may reduce the differences in outcomes between the groups.
Bottom Line: Five-year mortality is lower in nondiabetic patients with multivessel CAD treated with CABG compared with PCI with DES.
Citation: Chang M, Ahn JM, Lee CW, et al. Long-term mortality after coronary revascularization in nondiabetic patients with multivessel disease. J Am Coll Cardiol. 2016;68(1):29-36.
Clinical Question: Is there a mortality difference in nondiabetic patients with multivessel coronary artery disease (CAD) treated with coronary artery bypass graft (CABG) versus percutaneous coronary intervention (PCI)?
Background: Randomized clinical trials have shown a mortality benefit of CABG over PCI with drug-eluting stents (DES) for diabetic patients. The best strategy for nondiabetics, however, has not been well established.
Study Design: Pooled individual patient data from two large randomized clinical trials.
Setting: Multicenter, multinational (Europe, United States, Asia).
Synopsis: Excluding patients with left main disease, a total of 1,275 nondiabetic patients with two- or three-vessel CAD were analyzed. After median follow-up of 61 months, the CABG group had significantly fewer deaths from any cause (hazard ratio [HR], 0.65; 95% CI, 0.43–0.98; P=0.039) as well as fewer deaths from cardiac causes (HR, 0.41; 95% CI, 0.25–0.78; P=0.005) when compared to PCI with DES. The benefit was primarily seen at five-year follow-up in patients with intermediate to severe disease, with a nonsignificant difference detected in patients with less severe disease.
Despite the increasing popularity of DES, this study suggests that for nondiabetic patients with CAD, there is a mortality benefit at five years favoring CABG over PCI with DES. However, in this study stents used for PCI included both older and newer generation DES; a study using only newer DES may reduce the differences in outcomes between the groups.
Bottom Line: Five-year mortality is lower in nondiabetic patients with multivessel CAD treated with CABG compared with PCI with DES.
Citation: Chang M, Ahn JM, Lee CW, et al. Long-term mortality after coronary revascularization in nondiabetic patients with multivessel disease. J Am Coll Cardiol. 2016;68(1):29-36.
Clinical Question: Is there a mortality difference in nondiabetic patients with multivessel coronary artery disease (CAD) treated with coronary artery bypass graft (CABG) versus percutaneous coronary intervention (PCI)?
Background: Randomized clinical trials have shown a mortality benefit of CABG over PCI with drug-eluting stents (DES) for diabetic patients. The best strategy for nondiabetics, however, has not been well established.
Study Design: Pooled individual patient data from two large randomized clinical trials.
Setting: Multicenter, multinational (Europe, United States, Asia).
Synopsis: Excluding patients with left main disease, a total of 1,275 nondiabetic patients with two- or three-vessel CAD were analyzed. After median follow-up of 61 months, the CABG group had significantly fewer deaths from any cause (hazard ratio [HR], 0.65; 95% CI, 0.43–0.98; P=0.039) as well as fewer deaths from cardiac causes (HR, 0.41; 95% CI, 0.25–0.78; P=0.005) when compared to PCI with DES. The benefit was primarily seen at five-year follow-up in patients with intermediate to severe disease, with a nonsignificant difference detected in patients with less severe disease.
Despite the increasing popularity of DES, this study suggests that for nondiabetic patients with CAD, there is a mortality benefit at five years favoring CABG over PCI with DES. However, in this study stents used for PCI included both older and newer generation DES; a study using only newer DES may reduce the differences in outcomes between the groups.
Bottom Line: Five-year mortality is lower in nondiabetic patients with multivessel CAD treated with CABG compared with PCI with DES.
Citation: Chang M, Ahn JM, Lee CW, et al. Long-term mortality after coronary revascularization in nondiabetic patients with multivessel disease. J Am Coll Cardiol. 2016;68(1):29-36.
Prolonged Ceftaroline Exposure Associated with High Incidence of Neutropenia
Clinical Question: What is the incidence of neutropenia in patients treated with prolonged courses of ceftaroline?
Background: Ceftaroline, a new broad-spectrum cephalosporin antibiotic, is FDA approved for the treatment of skin and soft-tissue infections and community-acquired pneumonia (CAP). Other than a few case reports, previous studies have not assessed the incidence of neutropenia in patients receiving ceftaroline for off-label indications or for prolonged courses.
Study Design: Retrospective chart review.
Setting: Brigham and Women’s Hospital and Massachusetts General Hospital in Boston.
Synopsis: The authors identified 67 patients who received ceftaroline for seven or more consecutive days. Overall, ceftaroline exposure for two or more weeks was associated with a 10%–14% incidence of neutropenia (absolute neutrophil count less than 1,800 cells/mm3), and ceftaroline exposure for three or more weeks was associated with a 21% incidence of neutropenia. Both the mean duration of ceftaroline exposure and the total number of ceftaroline doses were associated with incident neutropenia.
This is the first study to systematically assess the incidence of ceftaroline-associated neutropenia. The data support a correlation between cumulative ceftaroline exposure and neutropenia. Hospitalists managing patients with prolonged courses of ceftaroline should carefully monitor hematologic studies during treatment.
Bottom Line: The overall rate of neutropenia in patients receiving prolonged courses of ceftaroline is significant, and it is associated with duration of ceftaroline exposure and total number of doses received.
Citation: Furtek KJ, Kubiak DW, Barra M, Varughese C, Ashbaugh CD, Koo S. High incidence of neutropenia in patients with prolonged ceftaroline exposure. J Antimicrob Chemother. 2016;71(7):2010-2013.
Short Take
New Guidelines from IDSA/ATS for Patients with Community-Acquired Pneumonia Can Safely Be Implemented for Hospitalized Patients
A multicenter, non-inferiority randomized clinical trial of 312 patients with community-acquired pneumonia (CAP) found that stopping antibiotics after five days was not associated with worse outcomes and may reduce readmissions.
Citation: Uranga A, España PP, Bilbao A, et al. Duration of antibiotic treatment in community-acquired pneumonia: a multicenter randomized clinical trial. JAMA Intern Med. 2016;176(9):1257-1265.
Clinical Question: What is the incidence of neutropenia in patients treated with prolonged courses of ceftaroline?
Background: Ceftaroline, a new broad-spectrum cephalosporin antibiotic, is FDA approved for the treatment of skin and soft-tissue infections and community-acquired pneumonia (CAP). Other than a few case reports, previous studies have not assessed the incidence of neutropenia in patients receiving ceftaroline for off-label indications or for prolonged courses.
Study Design: Retrospective chart review.
Setting: Brigham and Women’s Hospital and Massachusetts General Hospital in Boston.
Synopsis: The authors identified 67 patients who received ceftaroline for seven or more consecutive days. Overall, ceftaroline exposure for two or more weeks was associated with a 10%–14% incidence of neutropenia (absolute neutrophil count less than 1,800 cells/mm3), and ceftaroline exposure for three or more weeks was associated with a 21% incidence of neutropenia. Both the mean duration of ceftaroline exposure and the total number of ceftaroline doses were associated with incident neutropenia.
This is the first study to systematically assess the incidence of ceftaroline-associated neutropenia. The data support a correlation between cumulative ceftaroline exposure and neutropenia. Hospitalists managing patients with prolonged courses of ceftaroline should carefully monitor hematologic studies during treatment.
Bottom Line: The overall rate of neutropenia in patients receiving prolonged courses of ceftaroline is significant, and it is associated with duration of ceftaroline exposure and total number of doses received.
Citation: Furtek KJ, Kubiak DW, Barra M, Varughese C, Ashbaugh CD, Koo S. High incidence of neutropenia in patients with prolonged ceftaroline exposure. J Antimicrob Chemother. 2016;71(7):2010-2013.
Short Take
New Guidelines from IDSA/ATS for Patients with Community-Acquired Pneumonia Can Safely Be Implemented for Hospitalized Patients
A multicenter, non-inferiority randomized clinical trial of 312 patients with community-acquired pneumonia (CAP) found that stopping antibiotics after five days was not associated with worse outcomes and may reduce readmissions.
Citation: Uranga A, España PP, Bilbao A, et al. Duration of antibiotic treatment in community-acquired pneumonia: a multicenter randomized clinical trial. JAMA Intern Med. 2016;176(9):1257-1265.
Clinical Question: What is the incidence of neutropenia in patients treated with prolonged courses of ceftaroline?
Background: Ceftaroline, a new broad-spectrum cephalosporin antibiotic, is FDA approved for the treatment of skin and soft-tissue infections and community-acquired pneumonia (CAP). Other than a few case reports, previous studies have not assessed the incidence of neutropenia in patients receiving ceftaroline for off-label indications or for prolonged courses.
Study Design: Retrospective chart review.
Setting: Brigham and Women’s Hospital and Massachusetts General Hospital in Boston.
Synopsis: The authors identified 67 patients who received ceftaroline for seven or more consecutive days. Overall, ceftaroline exposure for two or more weeks was associated with a 10%–14% incidence of neutropenia (absolute neutrophil count less than 1,800 cells/mm3), and ceftaroline exposure for three or more weeks was associated with a 21% incidence of neutropenia. Both the mean duration of ceftaroline exposure and the total number of ceftaroline doses were associated with incident neutropenia.
This is the first study to systematically assess the incidence of ceftaroline-associated neutropenia. The data support a correlation between cumulative ceftaroline exposure and neutropenia. Hospitalists managing patients with prolonged courses of ceftaroline should carefully monitor hematologic studies during treatment.
Bottom Line: The overall rate of neutropenia in patients receiving prolonged courses of ceftaroline is significant, and it is associated with duration of ceftaroline exposure and total number of doses received.
Citation: Furtek KJ, Kubiak DW, Barra M, Varughese C, Ashbaugh CD, Koo S. High incidence of neutropenia in patients with prolonged ceftaroline exposure. J Antimicrob Chemother. 2016;71(7):2010-2013.
Short Take
New Guidelines from IDSA/ATS for Patients with Community-Acquired Pneumonia Can Safely Be Implemented for Hospitalized Patients
A multicenter, non-inferiority randomized clinical trial of 312 patients with community-acquired pneumonia (CAP) found that stopping antibiotics after five days was not associated with worse outcomes and may reduce readmissions.
Citation: Uranga A, España PP, Bilbao A, et al. Duration of antibiotic treatment in community-acquired pneumonia: a multicenter randomized clinical trial. JAMA Intern Med. 2016;176(9):1257-1265.