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Look for functional esophageal disorders if GERD patients fail PPIs
In a small, first-in-kind study, functional heartburn or reflux hypersensitivity affected fully 75% of patients whose gastroesophageal reflux disease symptoms had not improved with once-daily proton pump inhibitor therapy.
At the same time, proton pump inhibitor (PPI) responders and nonresponders had similar impedance and pH parameters, reported Jason Abdallah, MD, of Case Western Reserve University, Cleveland, and his associates. The findings show “the important role of esophageal hypersensitivity in this patient population.” For these patients, the investigators suggested adding a neuromodulator and possibly psychotherapy, such as cognitive-behavioral therapy, hypnotherapy, relaxation techniques, mindfulness, and biofeedback.
Symptoms in up to 45% of patients with gastroesophageal reflux disease (GERD) persist despite once-daily PPI therapy, Dr. Abdallah and his associates wrote in Clinical Gastroenterology and Hepatology. For the study, they compared reflux characteristics and patterns between 13 patients whose GERD symptoms had fully resolved on standard once-daily PPIs and 16 patients who reported at least twice-weekly heartburn, regurgitation, or both for at least 3 months, despite treatment. Patients in both groups continued PPIs and underwent upper endoscopy and combined esophageal impedance–pH monitoring.
The average age of patients in this study was 54.5 years, with a standard deviation of 14.5 years. Demographic and clinical characteristics were similar between groups, and patients in both groups were receiving omeprazole, esomeprazole, or pantoprazole. Four (31%) PPI responders had abnormal pH test results, as did four (25%) nonresponders. Responders and nonresponders had similar numbers of reflux events; proportions of events that were acidic, weakly acidic, or alkaline; and mean total time with pH less than 4.0.
Additionally, most patients in both groups had normal endoscopic findings. One PPI responder had Los Angeles grade A erosive esophagitis, and two PPI responders had short-segment Barrett’s esophagus. Three PPI responders and two PPI nonresponders had nonobstructive Schatzki rings, and one PPI nonresponder had an esophageal stricture. Finally, five PPI responders (38%) and three nonresponders (19%) had hiatal hernias (P = .41).
In patients with GERD, “PPI failure” does not reflect a unique pattern of reflux events, acid exposure, or nonacidic reflux parameters, Dr. Abdallah and his associates concluded. The fact that most PPI nonresponders had a concurrent functional esophageal disorder – either reflux hypersensitivity or functional heartburn – “support[s] the hypothesis that PPI failure is primarily driven by esophageal hypersensitivity.”
This was a small study – recruitment “was hampered by the invasive nature of some of the procedures,” they wrote. “In addition, it is our experience that many patients who have responded to PPI [therapy] are reluctant to undergo invasive testing as part of a study protocol. Therefore, we believe that these types of prospective, invasive studies are rather difficult to perform but, at the same time, provide essential insight into the understanding of refractory GERD.”
No external funding sources were acknowledged. The senior author reported ties to Ironwood Pharmaceuticals, Mederi Therapeutics, Ethicon, AstraZeneca, and Takeda. The other researchers reported no conflicts of interest.
SOURCE: Abdallah J et al. Clin Gastroenterol Hepatol. 2018 Jun 15. doi: 10.1016/j.cgh.2018.09.006.
In a small, first-in-kind study, functional heartburn or reflux hypersensitivity affected fully 75% of patients whose gastroesophageal reflux disease symptoms had not improved with once-daily proton pump inhibitor therapy.
At the same time, proton pump inhibitor (PPI) responders and nonresponders had similar impedance and pH parameters, reported Jason Abdallah, MD, of Case Western Reserve University, Cleveland, and his associates. The findings show “the important role of esophageal hypersensitivity in this patient population.” For these patients, the investigators suggested adding a neuromodulator and possibly psychotherapy, such as cognitive-behavioral therapy, hypnotherapy, relaxation techniques, mindfulness, and biofeedback.
Symptoms in up to 45% of patients with gastroesophageal reflux disease (GERD) persist despite once-daily PPI therapy, Dr. Abdallah and his associates wrote in Clinical Gastroenterology and Hepatology. For the study, they compared reflux characteristics and patterns between 13 patients whose GERD symptoms had fully resolved on standard once-daily PPIs and 16 patients who reported at least twice-weekly heartburn, regurgitation, or both for at least 3 months, despite treatment. Patients in both groups continued PPIs and underwent upper endoscopy and combined esophageal impedance–pH monitoring.
The average age of patients in this study was 54.5 years, with a standard deviation of 14.5 years. Demographic and clinical characteristics were similar between groups, and patients in both groups were receiving omeprazole, esomeprazole, or pantoprazole. Four (31%) PPI responders had abnormal pH test results, as did four (25%) nonresponders. Responders and nonresponders had similar numbers of reflux events; proportions of events that were acidic, weakly acidic, or alkaline; and mean total time with pH less than 4.0.
Additionally, most patients in both groups had normal endoscopic findings. One PPI responder had Los Angeles grade A erosive esophagitis, and two PPI responders had short-segment Barrett’s esophagus. Three PPI responders and two PPI nonresponders had nonobstructive Schatzki rings, and one PPI nonresponder had an esophageal stricture. Finally, five PPI responders (38%) and three nonresponders (19%) had hiatal hernias (P = .41).
In patients with GERD, “PPI failure” does not reflect a unique pattern of reflux events, acid exposure, or nonacidic reflux parameters, Dr. Abdallah and his associates concluded. The fact that most PPI nonresponders had a concurrent functional esophageal disorder – either reflux hypersensitivity or functional heartburn – “support[s] the hypothesis that PPI failure is primarily driven by esophageal hypersensitivity.”
This was a small study – recruitment “was hampered by the invasive nature of some of the procedures,” they wrote. “In addition, it is our experience that many patients who have responded to PPI [therapy] are reluctant to undergo invasive testing as part of a study protocol. Therefore, we believe that these types of prospective, invasive studies are rather difficult to perform but, at the same time, provide essential insight into the understanding of refractory GERD.”
No external funding sources were acknowledged. The senior author reported ties to Ironwood Pharmaceuticals, Mederi Therapeutics, Ethicon, AstraZeneca, and Takeda. The other researchers reported no conflicts of interest.
SOURCE: Abdallah J et al. Clin Gastroenterol Hepatol. 2018 Jun 15. doi: 10.1016/j.cgh.2018.09.006.
In a small, first-in-kind study, functional heartburn or reflux hypersensitivity affected fully 75% of patients whose gastroesophageal reflux disease symptoms had not improved with once-daily proton pump inhibitor therapy.
At the same time, proton pump inhibitor (PPI) responders and nonresponders had similar impedance and pH parameters, reported Jason Abdallah, MD, of Case Western Reserve University, Cleveland, and his associates. The findings show “the important role of esophageal hypersensitivity in this patient population.” For these patients, the investigators suggested adding a neuromodulator and possibly psychotherapy, such as cognitive-behavioral therapy, hypnotherapy, relaxation techniques, mindfulness, and biofeedback.
Symptoms in up to 45% of patients with gastroesophageal reflux disease (GERD) persist despite once-daily PPI therapy, Dr. Abdallah and his associates wrote in Clinical Gastroenterology and Hepatology. For the study, they compared reflux characteristics and patterns between 13 patients whose GERD symptoms had fully resolved on standard once-daily PPIs and 16 patients who reported at least twice-weekly heartburn, regurgitation, or both for at least 3 months, despite treatment. Patients in both groups continued PPIs and underwent upper endoscopy and combined esophageal impedance–pH monitoring.
The average age of patients in this study was 54.5 years, with a standard deviation of 14.5 years. Demographic and clinical characteristics were similar between groups, and patients in both groups were receiving omeprazole, esomeprazole, or pantoprazole. Four (31%) PPI responders had abnormal pH test results, as did four (25%) nonresponders. Responders and nonresponders had similar numbers of reflux events; proportions of events that were acidic, weakly acidic, or alkaline; and mean total time with pH less than 4.0.
Additionally, most patients in both groups had normal endoscopic findings. One PPI responder had Los Angeles grade A erosive esophagitis, and two PPI responders had short-segment Barrett’s esophagus. Three PPI responders and two PPI nonresponders had nonobstructive Schatzki rings, and one PPI nonresponder had an esophageal stricture. Finally, five PPI responders (38%) and three nonresponders (19%) had hiatal hernias (P = .41).
In patients with GERD, “PPI failure” does not reflect a unique pattern of reflux events, acid exposure, or nonacidic reflux parameters, Dr. Abdallah and his associates concluded. The fact that most PPI nonresponders had a concurrent functional esophageal disorder – either reflux hypersensitivity or functional heartburn – “support[s] the hypothesis that PPI failure is primarily driven by esophageal hypersensitivity.”
This was a small study – recruitment “was hampered by the invasive nature of some of the procedures,” they wrote. “In addition, it is our experience that many patients who have responded to PPI [therapy] are reluctant to undergo invasive testing as part of a study protocol. Therefore, we believe that these types of prospective, invasive studies are rather difficult to perform but, at the same time, provide essential insight into the understanding of refractory GERD.”
No external funding sources were acknowledged. The senior author reported ties to Ironwood Pharmaceuticals, Mederi Therapeutics, Ethicon, AstraZeneca, and Takeda. The other researchers reported no conflicts of interest.
SOURCE: Abdallah J et al. Clin Gastroenterol Hepatol. 2018 Jun 15. doi: 10.1016/j.cgh.2018.09.006.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Alirocumab reduces both type 1 and 2 MIs
NEW ORLEANS – Lowering LDL cholesterol with alirocumab to levels below what’s achievable with intensive statin therapy appears to be an important strategy for prevention of type 1 MI – and perhaps even more impressively, type 2 MI – following acute coronary syndrome, Harvey D. White, MD, reported at the annual meeting of the American College of Cardiology.
What’s so important about the 23% reduction in risk of type 2 MI achieved with alirocumab (Praluent) relative to placebo documented in a prespecified secondary analysis from the ODYSSEY Outcomes trial?
“For type 2 MI, this is the first data indicating that a lipid-lowering therapy can attenuate risk,” according to Dr. White, a cardiologist at Auckland (N.Z.) City Hospital.
The ODYSSEY Outcomes trial compared the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab to placebo in 18,924 patients with a recent acute coronary syndrome and an LDL cholesterol level of at least 70 mg/dL despite intensive statin therapy. At 4 months, the PCSK9 inhibitor plus statin therapy reduced participants’ mean LDL by 54%, from 93 to 48 mg/dL, while the LDL level actually drifted upward in the control group on placebo plus statin therapy. In the previously reported primary results of this landmark randomized clinical trial, alirocumab on top of background intensive statin therapy reduced the primary composite endpoint of death attributable to coronary heart disease, ischemic stroke, MI, or unstable angina requiring hospitalization by 15%, compared with controls (N Engl J Med. 2018 Nov 29;379[22]:2097-107).
During a median 2.8 years of prospective follow-up, there were 1,860 new MIs in study participants. A blinded clinical events committee evaluated the myocardial infarctions according to the Third Universal Definition and determined 66% were type 1 MIs, 21% were type 2, and 13% were type 4, with lesser numbers of types 3 and 5 MI.
Alirocumab reduced the risk of any MI by 15%, with a 6.8% incidence during follow-up, compared with 7.9% on placebo. The risk of type 1 MI, typically attributable to plaque rupture, was reduced by 13%, with an incidence of 4.9% with alirocumab and 5.6% with placebo. The risk reduction conferred by the PCSK9 inhibitor was even more robust for type 2 MI, the type caused by an oxygen supply/demand imbalance most commonly attributable to coronary artery spasm, coronary embolism, arrhythmias, anemia, hypertension, or hypotension: a 23% relative risk reduction as reflected in a 1.3% incidence in the alirocumab group, compared with a 1.7% rate in controls.
In contrast, alirocumab had no impact on the incidence of type 4 MI, a category that includes peri–percutaneous coronary intervention MIs as well as those attributable to stent thrombosis or restenosis.
The beneficial effect of alirocumab on MI risk mostly involved a reduction in larger MIs – those with a biomarker peak greater than three times the upper limit of normal.
An emphatic difference was found in the risk of death following type 1 as opposed to type 2 MI. Patients who experienced a type 1 MI during the study had an 11.9% mortality rate during an average of 1.6 years of post-MI follow-up, as compared with a 25.4% rate during 1.3 years of follow-up after a type 2 MI.
Alirocumab significantly reduced the risk of mortality following a type 1 MI, with a 10.2% rate as compared to 13.4% with placebo; that’s a 31% relative risk reduction. Yet the PCSK9 inhibitor had no impact on the risk of death after a type 2 MI: 24.8% in the alirocumab group and 25.9% in controls.
Asked for his thoughts as to possible explanatory mechanistic pathways for the benefit of alirocumab in preventing type 2 MI, Dr. White noted that in a Scottish study of the PCSK9 inhibitor evolocumab (Repatha), over the course of 72 months the drug appeared to reduce atherosclerotic progression and induce plaque stabilization and perhaps even regression.
“I think that’s the probable mechanism. And we also know that statins improve endothelial function,” he said.
He reported receiving research grant support and consultant fees from Sanofi and Regeneron, funders of the ODYSSEY Outcomes trial.
NEW ORLEANS – Lowering LDL cholesterol with alirocumab to levels below what’s achievable with intensive statin therapy appears to be an important strategy for prevention of type 1 MI – and perhaps even more impressively, type 2 MI – following acute coronary syndrome, Harvey D. White, MD, reported at the annual meeting of the American College of Cardiology.
What’s so important about the 23% reduction in risk of type 2 MI achieved with alirocumab (Praluent) relative to placebo documented in a prespecified secondary analysis from the ODYSSEY Outcomes trial?
“For type 2 MI, this is the first data indicating that a lipid-lowering therapy can attenuate risk,” according to Dr. White, a cardiologist at Auckland (N.Z.) City Hospital.
The ODYSSEY Outcomes trial compared the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab to placebo in 18,924 patients with a recent acute coronary syndrome and an LDL cholesterol level of at least 70 mg/dL despite intensive statin therapy. At 4 months, the PCSK9 inhibitor plus statin therapy reduced participants’ mean LDL by 54%, from 93 to 48 mg/dL, while the LDL level actually drifted upward in the control group on placebo plus statin therapy. In the previously reported primary results of this landmark randomized clinical trial, alirocumab on top of background intensive statin therapy reduced the primary composite endpoint of death attributable to coronary heart disease, ischemic stroke, MI, or unstable angina requiring hospitalization by 15%, compared with controls (N Engl J Med. 2018 Nov 29;379[22]:2097-107).
During a median 2.8 years of prospective follow-up, there were 1,860 new MIs in study participants. A blinded clinical events committee evaluated the myocardial infarctions according to the Third Universal Definition and determined 66% were type 1 MIs, 21% were type 2, and 13% were type 4, with lesser numbers of types 3 and 5 MI.
Alirocumab reduced the risk of any MI by 15%, with a 6.8% incidence during follow-up, compared with 7.9% on placebo. The risk of type 1 MI, typically attributable to plaque rupture, was reduced by 13%, with an incidence of 4.9% with alirocumab and 5.6% with placebo. The risk reduction conferred by the PCSK9 inhibitor was even more robust for type 2 MI, the type caused by an oxygen supply/demand imbalance most commonly attributable to coronary artery spasm, coronary embolism, arrhythmias, anemia, hypertension, or hypotension: a 23% relative risk reduction as reflected in a 1.3% incidence in the alirocumab group, compared with a 1.7% rate in controls.
In contrast, alirocumab had no impact on the incidence of type 4 MI, a category that includes peri–percutaneous coronary intervention MIs as well as those attributable to stent thrombosis or restenosis.
The beneficial effect of alirocumab on MI risk mostly involved a reduction in larger MIs – those with a biomarker peak greater than three times the upper limit of normal.
An emphatic difference was found in the risk of death following type 1 as opposed to type 2 MI. Patients who experienced a type 1 MI during the study had an 11.9% mortality rate during an average of 1.6 years of post-MI follow-up, as compared with a 25.4% rate during 1.3 years of follow-up after a type 2 MI.
Alirocumab significantly reduced the risk of mortality following a type 1 MI, with a 10.2% rate as compared to 13.4% with placebo; that’s a 31% relative risk reduction. Yet the PCSK9 inhibitor had no impact on the risk of death after a type 2 MI: 24.8% in the alirocumab group and 25.9% in controls.
Asked for his thoughts as to possible explanatory mechanistic pathways for the benefit of alirocumab in preventing type 2 MI, Dr. White noted that in a Scottish study of the PCSK9 inhibitor evolocumab (Repatha), over the course of 72 months the drug appeared to reduce atherosclerotic progression and induce plaque stabilization and perhaps even regression.
“I think that’s the probable mechanism. And we also know that statins improve endothelial function,” he said.
He reported receiving research grant support and consultant fees from Sanofi and Regeneron, funders of the ODYSSEY Outcomes trial.
NEW ORLEANS – Lowering LDL cholesterol with alirocumab to levels below what’s achievable with intensive statin therapy appears to be an important strategy for prevention of type 1 MI – and perhaps even more impressively, type 2 MI – following acute coronary syndrome, Harvey D. White, MD, reported at the annual meeting of the American College of Cardiology.
What’s so important about the 23% reduction in risk of type 2 MI achieved with alirocumab (Praluent) relative to placebo documented in a prespecified secondary analysis from the ODYSSEY Outcomes trial?
“For type 2 MI, this is the first data indicating that a lipid-lowering therapy can attenuate risk,” according to Dr. White, a cardiologist at Auckland (N.Z.) City Hospital.
The ODYSSEY Outcomes trial compared the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab to placebo in 18,924 patients with a recent acute coronary syndrome and an LDL cholesterol level of at least 70 mg/dL despite intensive statin therapy. At 4 months, the PCSK9 inhibitor plus statin therapy reduced participants’ mean LDL by 54%, from 93 to 48 mg/dL, while the LDL level actually drifted upward in the control group on placebo plus statin therapy. In the previously reported primary results of this landmark randomized clinical trial, alirocumab on top of background intensive statin therapy reduced the primary composite endpoint of death attributable to coronary heart disease, ischemic stroke, MI, or unstable angina requiring hospitalization by 15%, compared with controls (N Engl J Med. 2018 Nov 29;379[22]:2097-107).
During a median 2.8 years of prospective follow-up, there were 1,860 new MIs in study participants. A blinded clinical events committee evaluated the myocardial infarctions according to the Third Universal Definition and determined 66% were type 1 MIs, 21% were type 2, and 13% were type 4, with lesser numbers of types 3 and 5 MI.
Alirocumab reduced the risk of any MI by 15%, with a 6.8% incidence during follow-up, compared with 7.9% on placebo. The risk of type 1 MI, typically attributable to plaque rupture, was reduced by 13%, with an incidence of 4.9% with alirocumab and 5.6% with placebo. The risk reduction conferred by the PCSK9 inhibitor was even more robust for type 2 MI, the type caused by an oxygen supply/demand imbalance most commonly attributable to coronary artery spasm, coronary embolism, arrhythmias, anemia, hypertension, or hypotension: a 23% relative risk reduction as reflected in a 1.3% incidence in the alirocumab group, compared with a 1.7% rate in controls.
In contrast, alirocumab had no impact on the incidence of type 4 MI, a category that includes peri–percutaneous coronary intervention MIs as well as those attributable to stent thrombosis or restenosis.
The beneficial effect of alirocumab on MI risk mostly involved a reduction in larger MIs – those with a biomarker peak greater than three times the upper limit of normal.
An emphatic difference was found in the risk of death following type 1 as opposed to type 2 MI. Patients who experienced a type 1 MI during the study had an 11.9% mortality rate during an average of 1.6 years of post-MI follow-up, as compared with a 25.4% rate during 1.3 years of follow-up after a type 2 MI.
Alirocumab significantly reduced the risk of mortality following a type 1 MI, with a 10.2% rate as compared to 13.4% with placebo; that’s a 31% relative risk reduction. Yet the PCSK9 inhibitor had no impact on the risk of death after a type 2 MI: 24.8% in the alirocumab group and 25.9% in controls.
Asked for his thoughts as to possible explanatory mechanistic pathways for the benefit of alirocumab in preventing type 2 MI, Dr. White noted that in a Scottish study of the PCSK9 inhibitor evolocumab (Repatha), over the course of 72 months the drug appeared to reduce atherosclerotic progression and induce plaque stabilization and perhaps even regression.
“I think that’s the probable mechanism. And we also know that statins improve endothelial function,” he said.
He reported receiving research grant support and consultant fees from Sanofi and Regeneron, funders of the ODYSSEY Outcomes trial.
REPORTING FROM ACC 19
Social media for physicians: Strong medicine or snake oil?
For most of us, social media is a daunting new reality that we are pressured to be part of but that we struggle to fit into our increasingly demanding schedules. My first social media foray as a physician was a Facebook fan page as a hobby rather than a professional presence. Years later, I have learned the incredible benefit that being on social media in other platforms brought to my profession.
What’s social media going to bring to my medical practice?
The days where physicians retreat to the safety of our offices to deliver our care, or to issue carefully structured opinions, or interactions with patients have made way for more direct interaction. Social media has, indeed, allowed us to share more personal glimpses of our daily struggle to save lives, behind-the-scenes snapshot of ethical struggles in decision making, our difficulties qualifying patients for therapies due to insurance complications, or real-time addressing medical news and combating misinformation. Moreover, when patients self-refer, or are referred to my practice, they look me up online before coming to my office. Online profiles are the new “first impression” of the bedside manner of a physician.
Other personal examples of social media benefits include being informed of new publications, since many journals now have an online presence; being able to interact in real-time with authors; learning from physicians in other countries how they handled issues, such as shortage of critical medications; or earning CME, such as the Twitter chats hosted by CHEST (eg, new biologic agents in difficult to treat asthma, or patient selection in triple therapy for COPD).
Why should I pay attention to social media presence?
The pace by which social media changed the landscape took the medical community by surprise. Patients, third-party websites, and online review agencies (official or not) adopted it well before physicians became comfortable with it. As such, when I decided to google myself online, I was shocked at the level of misinformation about me (as a pulmonologist, I didn’t know I had performed sigmoidoscopies, yet that’s what my patients learned before they met me). That was an important lesson: If I don’t control the narrative, someone else will. Consequently, I dedicated a few hours to establish an online presence in order to introduce myself accurately and to be accessible to my patients and colleagues online.
Who decides what’s ethical and what’s not?
As the lines blurred, our community struggled to define what was appropriate and what was not. Finally, we welcomed with relief the issuance of a Code of Ethics, regarding social media use by physicians, from several societies, including the American Medical Association (https://www.ama-assn.org/delivering-care/ethics/professionalism-use-social-media). The principles guiding physicians use of social media include respect for human dignity and rights, honesty and upholding the standards of professionalism, and the duty to safeguard patient confidences and privacy.
Which platform should I use? There are so many.
While any content can be shared on any platform, social media sites have organically differentiated into being more amenable to one content vs the other. Some accounts tend to be more for professional use (ie, Twitter and LinkedIn), and other accounts for personal use (ie, Facebook, Instagram, Snapchat, and Pinterest). CHEST has selected Twitter to host its CME chats regarding preselected topics, post information about an upcoming lecture during the CHEST meeting, etc. New social media sites are now “physician only,” such as Sermo, Doximity, QuantiMD, and Doc2Doc. Many of these sites require doctors to submit their credentials to a site gatekeeper, recreating the intimacy of a “physicians’ lounge” in an online environment (J Med Internet Res. 2014:Feb 11;16[2]:e13). Lastly, Figure1 is a media sharing app between physicians allowing discussions of de-identified images or cases, recreating the “curbside” consult concept online.
I heard about hashtags. What are they?
Hashtags are simply clickable topic titles (#COPD #Sepsis # Education, etc.) that can be added to a post, in order to widen its reach. For instance, if I am interested in sepsis, I can click on the hashtag #Sepsis, and it would bring up all the posts on any Twitter account that added that hashtag. It’s a filter that takes me to that topic of interest. I can then click on the button “Like” on the message or the account itself where the post was found. The “Like” is similar to a bookmark for that account on my own Twitter. In the future, all the posts from that account would be available to me.
What are influencers or thought leaders?
Anyone who “liked” my account is now “following” me. The number of followers has become a measure of the popularity of anyone on social media. If it reaches a high level, then the person with the account is dubbed an “influencer.” Social media “influencers” are individuals whose opinion is followed by hundreds of thousands. Influencers may even be rewarded for harnessing their reach to make money off advertising. One can easily see how it is powerful for a physician to become an influencer or a “thought leader,” not to make money but to expand their reach on social media to spread the correct information about diets, drugs, e-cigarettes, and vaccinations, to name a few.
Can social media get me in trouble?
In 2012, a survey of the state medical boards published by JAMA (2012;307[11]:1141) revealed that approximately 30% of state medical boards reported complaints of “online violations of patient confidentiality.” More than 10% stated they had encountered a case of an “online depiction of intoxication.”
Another study a year earlier revealed that 13% of physicians reported they have discussed individual, though anonymized, cases with other physicians in public online forums (http://www.quantiamd.com/qqcp/DoctorsPatientSocialMedia.pdf).
Even if posted anonymously, or on a “personal” rather than professional social media site, various investigative methods may potentially be used to directly link information to a specific person or incident. The most current case law dictates that such information is “discoverable.” In fact, Facebook’s policy for the use of data informs users that, “we may access, preserve, and share your information in response to a legal request” both within and outside of U.S. jurisdiction”.
What kind of trouble could I be exposed to?
Poor quality of information, damage to our professional image, breaches of patient’s privacy, violation of patient-physician boundary, license revoking by state boards, and erroneous medical advice given in the absence of examining a patient, are all potential pitfalls for physicians in the careless use of social media.
How can I minimize my legal risk when interacting online?
It has been suggested that a legally sound approach in response to requests for online medical advice would be to send a standard response form that:
• informs the inquirer that the health-care provider does not answer online questions;
• supplies offline contact information so that an appointment can be made, if desired; and
• identifies a source for emergency services if the inquirer cannot wait for an appointment.
In circumstances where a patient–physician relationship already exists, informed consent should be obtained, which should include a careful explanation regarding the risks of online communication, expected response times, and the handling of emergencies, then documented in the patient’s chart (PT. 2014 Jul;39[7]:491,520).
In Summary
Social media, much like any area of medicine one is interested in, can be daunting and exciting but fraught with potential difficulties. I liken its adoption in our daily practice to any other decision or interest, including being in a private or academic setting, adopting procedural medicine or sticking to diagnostic consultations, or participating in research. In the end, it’s an individual expression of our desire to practice medicine. However, verifying information already existing online about us is of paramount importance. If I don’t tell my story, someone else will, and they may not be as truthful.
Dr. Bencheqroun is Assistant Professor, University of California Riverside School of Medicine, Pulmonary/Critical Care Faculty Program Coordinator & Research Mentor - Internal Medicine Residency Program Desert Regional Medical Center, Palm Springs CA; and Immediate Past Chair of the CHEST Council of Networks.
For most of us, social media is a daunting new reality that we are pressured to be part of but that we struggle to fit into our increasingly demanding schedules. My first social media foray as a physician was a Facebook fan page as a hobby rather than a professional presence. Years later, I have learned the incredible benefit that being on social media in other platforms brought to my profession.
What’s social media going to bring to my medical practice?
The days where physicians retreat to the safety of our offices to deliver our care, or to issue carefully structured opinions, or interactions with patients have made way for more direct interaction. Social media has, indeed, allowed us to share more personal glimpses of our daily struggle to save lives, behind-the-scenes snapshot of ethical struggles in decision making, our difficulties qualifying patients for therapies due to insurance complications, or real-time addressing medical news and combating misinformation. Moreover, when patients self-refer, or are referred to my practice, they look me up online before coming to my office. Online profiles are the new “first impression” of the bedside manner of a physician.
Other personal examples of social media benefits include being informed of new publications, since many journals now have an online presence; being able to interact in real-time with authors; learning from physicians in other countries how they handled issues, such as shortage of critical medications; or earning CME, such as the Twitter chats hosted by CHEST (eg, new biologic agents in difficult to treat asthma, or patient selection in triple therapy for COPD).
Why should I pay attention to social media presence?
The pace by which social media changed the landscape took the medical community by surprise. Patients, third-party websites, and online review agencies (official or not) adopted it well before physicians became comfortable with it. As such, when I decided to google myself online, I was shocked at the level of misinformation about me (as a pulmonologist, I didn’t know I had performed sigmoidoscopies, yet that’s what my patients learned before they met me). That was an important lesson: If I don’t control the narrative, someone else will. Consequently, I dedicated a few hours to establish an online presence in order to introduce myself accurately and to be accessible to my patients and colleagues online.
Who decides what’s ethical and what’s not?
As the lines blurred, our community struggled to define what was appropriate and what was not. Finally, we welcomed with relief the issuance of a Code of Ethics, regarding social media use by physicians, from several societies, including the American Medical Association (https://www.ama-assn.org/delivering-care/ethics/professionalism-use-social-media). The principles guiding physicians use of social media include respect for human dignity and rights, honesty and upholding the standards of professionalism, and the duty to safeguard patient confidences and privacy.
Which platform should I use? There are so many.
While any content can be shared on any platform, social media sites have organically differentiated into being more amenable to one content vs the other. Some accounts tend to be more for professional use (ie, Twitter and LinkedIn), and other accounts for personal use (ie, Facebook, Instagram, Snapchat, and Pinterest). CHEST has selected Twitter to host its CME chats regarding preselected topics, post information about an upcoming lecture during the CHEST meeting, etc. New social media sites are now “physician only,” such as Sermo, Doximity, QuantiMD, and Doc2Doc. Many of these sites require doctors to submit their credentials to a site gatekeeper, recreating the intimacy of a “physicians’ lounge” in an online environment (J Med Internet Res. 2014:Feb 11;16[2]:e13). Lastly, Figure1 is a media sharing app between physicians allowing discussions of de-identified images or cases, recreating the “curbside” consult concept online.
I heard about hashtags. What are they?
Hashtags are simply clickable topic titles (#COPD #Sepsis # Education, etc.) that can be added to a post, in order to widen its reach. For instance, if I am interested in sepsis, I can click on the hashtag #Sepsis, and it would bring up all the posts on any Twitter account that added that hashtag. It’s a filter that takes me to that topic of interest. I can then click on the button “Like” on the message or the account itself where the post was found. The “Like” is similar to a bookmark for that account on my own Twitter. In the future, all the posts from that account would be available to me.
What are influencers or thought leaders?
Anyone who “liked” my account is now “following” me. The number of followers has become a measure of the popularity of anyone on social media. If it reaches a high level, then the person with the account is dubbed an “influencer.” Social media “influencers” are individuals whose opinion is followed by hundreds of thousands. Influencers may even be rewarded for harnessing their reach to make money off advertising. One can easily see how it is powerful for a physician to become an influencer or a “thought leader,” not to make money but to expand their reach on social media to spread the correct information about diets, drugs, e-cigarettes, and vaccinations, to name a few.
Can social media get me in trouble?
In 2012, a survey of the state medical boards published by JAMA (2012;307[11]:1141) revealed that approximately 30% of state medical boards reported complaints of “online violations of patient confidentiality.” More than 10% stated they had encountered a case of an “online depiction of intoxication.”
Another study a year earlier revealed that 13% of physicians reported they have discussed individual, though anonymized, cases with other physicians in public online forums (http://www.quantiamd.com/qqcp/DoctorsPatientSocialMedia.pdf).
Even if posted anonymously, or on a “personal” rather than professional social media site, various investigative methods may potentially be used to directly link information to a specific person or incident. The most current case law dictates that such information is “discoverable.” In fact, Facebook’s policy for the use of data informs users that, “we may access, preserve, and share your information in response to a legal request” both within and outside of U.S. jurisdiction”.
What kind of trouble could I be exposed to?
Poor quality of information, damage to our professional image, breaches of patient’s privacy, violation of patient-physician boundary, license revoking by state boards, and erroneous medical advice given in the absence of examining a patient, are all potential pitfalls for physicians in the careless use of social media.
How can I minimize my legal risk when interacting online?
It has been suggested that a legally sound approach in response to requests for online medical advice would be to send a standard response form that:
• informs the inquirer that the health-care provider does not answer online questions;
• supplies offline contact information so that an appointment can be made, if desired; and
• identifies a source for emergency services if the inquirer cannot wait for an appointment.
In circumstances where a patient–physician relationship already exists, informed consent should be obtained, which should include a careful explanation regarding the risks of online communication, expected response times, and the handling of emergencies, then documented in the patient’s chart (PT. 2014 Jul;39[7]:491,520).
In Summary
Social media, much like any area of medicine one is interested in, can be daunting and exciting but fraught with potential difficulties. I liken its adoption in our daily practice to any other decision or interest, including being in a private or academic setting, adopting procedural medicine or sticking to diagnostic consultations, or participating in research. In the end, it’s an individual expression of our desire to practice medicine. However, verifying information already existing online about us is of paramount importance. If I don’t tell my story, someone else will, and they may not be as truthful.
Dr. Bencheqroun is Assistant Professor, University of California Riverside School of Medicine, Pulmonary/Critical Care Faculty Program Coordinator & Research Mentor - Internal Medicine Residency Program Desert Regional Medical Center, Palm Springs CA; and Immediate Past Chair of the CHEST Council of Networks.
For most of us, social media is a daunting new reality that we are pressured to be part of but that we struggle to fit into our increasingly demanding schedules. My first social media foray as a physician was a Facebook fan page as a hobby rather than a professional presence. Years later, I have learned the incredible benefit that being on social media in other platforms brought to my profession.
What’s social media going to bring to my medical practice?
The days where physicians retreat to the safety of our offices to deliver our care, or to issue carefully structured opinions, or interactions with patients have made way for more direct interaction. Social media has, indeed, allowed us to share more personal glimpses of our daily struggle to save lives, behind-the-scenes snapshot of ethical struggles in decision making, our difficulties qualifying patients for therapies due to insurance complications, or real-time addressing medical news and combating misinformation. Moreover, when patients self-refer, or are referred to my practice, they look me up online before coming to my office. Online profiles are the new “first impression” of the bedside manner of a physician.
Other personal examples of social media benefits include being informed of new publications, since many journals now have an online presence; being able to interact in real-time with authors; learning from physicians in other countries how they handled issues, such as shortage of critical medications; or earning CME, such as the Twitter chats hosted by CHEST (eg, new biologic agents in difficult to treat asthma, or patient selection in triple therapy for COPD).
Why should I pay attention to social media presence?
The pace by which social media changed the landscape took the medical community by surprise. Patients, third-party websites, and online review agencies (official or not) adopted it well before physicians became comfortable with it. As such, when I decided to google myself online, I was shocked at the level of misinformation about me (as a pulmonologist, I didn’t know I had performed sigmoidoscopies, yet that’s what my patients learned before they met me). That was an important lesson: If I don’t control the narrative, someone else will. Consequently, I dedicated a few hours to establish an online presence in order to introduce myself accurately and to be accessible to my patients and colleagues online.
Who decides what’s ethical and what’s not?
As the lines blurred, our community struggled to define what was appropriate and what was not. Finally, we welcomed with relief the issuance of a Code of Ethics, regarding social media use by physicians, from several societies, including the American Medical Association (https://www.ama-assn.org/delivering-care/ethics/professionalism-use-social-media). The principles guiding physicians use of social media include respect for human dignity and rights, honesty and upholding the standards of professionalism, and the duty to safeguard patient confidences and privacy.
Which platform should I use? There are so many.
While any content can be shared on any platform, social media sites have organically differentiated into being more amenable to one content vs the other. Some accounts tend to be more for professional use (ie, Twitter and LinkedIn), and other accounts for personal use (ie, Facebook, Instagram, Snapchat, and Pinterest). CHEST has selected Twitter to host its CME chats regarding preselected topics, post information about an upcoming lecture during the CHEST meeting, etc. New social media sites are now “physician only,” such as Sermo, Doximity, QuantiMD, and Doc2Doc. Many of these sites require doctors to submit their credentials to a site gatekeeper, recreating the intimacy of a “physicians’ lounge” in an online environment (J Med Internet Res. 2014:Feb 11;16[2]:e13). Lastly, Figure1 is a media sharing app between physicians allowing discussions of de-identified images or cases, recreating the “curbside” consult concept online.
I heard about hashtags. What are they?
Hashtags are simply clickable topic titles (#COPD #Sepsis # Education, etc.) that can be added to a post, in order to widen its reach. For instance, if I am interested in sepsis, I can click on the hashtag #Sepsis, and it would bring up all the posts on any Twitter account that added that hashtag. It’s a filter that takes me to that topic of interest. I can then click on the button “Like” on the message or the account itself where the post was found. The “Like” is similar to a bookmark for that account on my own Twitter. In the future, all the posts from that account would be available to me.
What are influencers or thought leaders?
Anyone who “liked” my account is now “following” me. The number of followers has become a measure of the popularity of anyone on social media. If it reaches a high level, then the person with the account is dubbed an “influencer.” Social media “influencers” are individuals whose opinion is followed by hundreds of thousands. Influencers may even be rewarded for harnessing their reach to make money off advertising. One can easily see how it is powerful for a physician to become an influencer or a “thought leader,” not to make money but to expand their reach on social media to spread the correct information about diets, drugs, e-cigarettes, and vaccinations, to name a few.
Can social media get me in trouble?
In 2012, a survey of the state medical boards published by JAMA (2012;307[11]:1141) revealed that approximately 30% of state medical boards reported complaints of “online violations of patient confidentiality.” More than 10% stated they had encountered a case of an “online depiction of intoxication.”
Another study a year earlier revealed that 13% of physicians reported they have discussed individual, though anonymized, cases with other physicians in public online forums (http://www.quantiamd.com/qqcp/DoctorsPatientSocialMedia.pdf).
Even if posted anonymously, or on a “personal” rather than professional social media site, various investigative methods may potentially be used to directly link information to a specific person or incident. The most current case law dictates that such information is “discoverable.” In fact, Facebook’s policy for the use of data informs users that, “we may access, preserve, and share your information in response to a legal request” both within and outside of U.S. jurisdiction”.
What kind of trouble could I be exposed to?
Poor quality of information, damage to our professional image, breaches of patient’s privacy, violation of patient-physician boundary, license revoking by state boards, and erroneous medical advice given in the absence of examining a patient, are all potential pitfalls for physicians in the careless use of social media.
How can I minimize my legal risk when interacting online?
It has been suggested that a legally sound approach in response to requests for online medical advice would be to send a standard response form that:
• informs the inquirer that the health-care provider does not answer online questions;
• supplies offline contact information so that an appointment can be made, if desired; and
• identifies a source for emergency services if the inquirer cannot wait for an appointment.
In circumstances where a patient–physician relationship already exists, informed consent should be obtained, which should include a careful explanation regarding the risks of online communication, expected response times, and the handling of emergencies, then documented in the patient’s chart (PT. 2014 Jul;39[7]:491,520).
In Summary
Social media, much like any area of medicine one is interested in, can be daunting and exciting but fraught with potential difficulties. I liken its adoption in our daily practice to any other decision or interest, including being in a private or academic setting, adopting procedural medicine or sticking to diagnostic consultations, or participating in research. In the end, it’s an individual expression of our desire to practice medicine. However, verifying information already existing online about us is of paramount importance. If I don’t tell my story, someone else will, and they may not be as truthful.
Dr. Bencheqroun is Assistant Professor, University of California Riverside School of Medicine, Pulmonary/Critical Care Faculty Program Coordinator & Research Mentor - Internal Medicine Residency Program Desert Regional Medical Center, Palm Springs CA; and Immediate Past Chair of the CHEST Council of Networks.
This month in the journal CHEST®
Editor’s Picks
Richard S. Irwin, MD, Master FCCP
Giants in Chest Medicine
David C. Zavala, MD, FCCP
Original Research
Accuracy of Algorithms to Identify Pulmonary Arterial Hypertension in Administrative Data:
A Systematic Review. By K. R. Gillmeyer, et al.
Hypersensitivity Pneumonitis: Radiologic Phenotypes Are Associated With Distinct Survival
Time and Pulmonary Function Trajectory. By M. L. Salisbury, et al.
The Effects of Long-term CPAP on Weight Change in Patients With Comorbid OSA and
Cardiovascular Disease: Data From the SAVE Trial. By Q. Ou, et al, on behalf of the SAVE investigators.
Editor’s Picks
Richard S. Irwin, MD, Master FCCP
Giants in Chest Medicine
David C. Zavala, MD, FCCP
Original Research
Accuracy of Algorithms to Identify Pulmonary Arterial Hypertension in Administrative Data:
A Systematic Review. By K. R. Gillmeyer, et al.
Hypersensitivity Pneumonitis: Radiologic Phenotypes Are Associated With Distinct Survival
Time and Pulmonary Function Trajectory. By M. L. Salisbury, et al.
The Effects of Long-term CPAP on Weight Change in Patients With Comorbid OSA and
Cardiovascular Disease: Data From the SAVE Trial. By Q. Ou, et al, on behalf of the SAVE investigators.
Editor’s Picks
Richard S. Irwin, MD, Master FCCP
Giants in Chest Medicine
David C. Zavala, MD, FCCP
Original Research
Accuracy of Algorithms to Identify Pulmonary Arterial Hypertension in Administrative Data:
A Systematic Review. By K. R. Gillmeyer, et al.
Hypersensitivity Pneumonitis: Radiologic Phenotypes Are Associated With Distinct Survival
Time and Pulmonary Function Trajectory. By M. L. Salisbury, et al.
The Effects of Long-term CPAP on Weight Change in Patients With Comorbid OSA and
Cardiovascular Disease: Data From the SAVE Trial. By Q. Ou, et al, on behalf of the SAVE investigators.
Updates from your CHEST Board of Regents
In late January, your Board of Regents met for its first face-to-face quarterly meeting under the leadership of new President Clayton Cowl, MD, MS, FCCP. One of the most valuable aspects of serving on the Board is an opportunity to take an overall look at the direction of the organization. The Board makes a concerted effort not to get too deep into the weeds planning out specific tactics for achieving goals; we have a great many outstanding volunteers serving on dozens of our committees who do an incredible job of making things happen. The Board tries to focus on overall organizational strategy. Are we going in the right direction? Are there opportunities of which we should be taking better advantage? Are there efforts in which we are currently engaged that may not be yielding outcomes as we expected? To better answer these questions, Dr. Cowl and his team asked all members of the Board of Regents and the Strategic Planning Subcommittee members of the Foundation Board of Trustees, as well as senior CHEST staff, to engage in an environmental scan to take an aggressive look at where we are and where we are headed. The output from our first environmental scan is currently being curated into a list of highest priority items that will be shared with the general membership in the coming months.
A review of our accomplishments over the last 6 months came next. Our new Executive Vice President and Chief Operating Officer, Dr. Robert Musacchio, has superseded all expectations in his first few months in the role. In addition to continuing to push the organization toward the “One CHEST” model by better integrating the Foundation with the College, as well as refining our operating principles in working with industry, Bob is further developing our international reach—exploring collaborations with a number of large international societies and planning meetings abroad later this year (CHEST Congress Thailand and CHEST Regional Congress Athens) and into the next (in Italy, with the regional meeting location to be determined). We are also in the process of recruiting for a new position, Chief Learning Officer, a role that will serve not only to better organize the educational activities of CHEST, but to also serve as a visionary to better imagine what future projects we should be pursuing to be of better service and value to our members.
We took a few moments to recognize the new, incoming Editor in Chief of the journal CHEST®; Peter Mazzone, MD, FCCP, will have some huge shoes to fill in taking the editor’s chair from Richard Irwin, MD, Master FCCP, who has served the journal in this role for more than a decade. Under Dr. Irwin’s leadership, CHEST has been the most-read publication amongst practicing pulmonary specialists; he is also responsible for having launched CHEST’s social media presence, including both video series that integrated directly with the journal (such as Ultrasound Corner) and podcasts. Richard also spoke beautifully about his passion for patient-centered care as a keynote speaker at CHEST 2018. Peter has outlined a number of different areas of focus for the journal in the next year, including putting a high priority on improving the reader experience and crafting an even better web and multimedia presence. We look forward to great things from the journal!
Chris Carroll, MD, FCCP, who chairs CHEST’s Digital Strategy Task Force, presented to the Board on their progress to date. The goal of this group is to evaluate the user experience for CHEST’s content delivery platforms, including the website, apps, and our social media platforms to identify opportunities for improvements that will enable us to better provide our members with on demand, high quality information to improve patient care through a personalized, seamless digital user experience. The team is being co-led by Nicki Augustyn, Senior Vice President for Marketing, Communications, and Publishing, and Ron Moen, Chief Information Officer. We look forward to further updates on this important project.
As I stated in my opening, many of the good things that CHEST does can only happen with the participation of our great members, and so I want to take the time to recognize the NetWorks and everything that they do for the College. In the past year, under the leadership of Council of NetWorks Chairs Hassan Bencheqroun, MD, FCCP, and David Zielinski, MD, FCCP, the NetWorks produced more than 60% of the content at the 2018 CHEST meeting and are actively working on projects ranging from creating educational videos for public consumption to CHEST guidelines proposals and crafting a donor registry for lung transplantation. Our volunteer leaders are our most valuable resource; if you are not currently engaged in the NetWorks, please consider getting involved this spring during the nomination process!
It remains a privilege for the Board to serve this great organization. If you are interested in hearing more, or getting more engaged, please send me an email at [email protected].
David A. Schulman, MD, FCCP
In late January, your Board of Regents met for its first face-to-face quarterly meeting under the leadership of new President Clayton Cowl, MD, MS, FCCP. One of the most valuable aspects of serving on the Board is an opportunity to take an overall look at the direction of the organization. The Board makes a concerted effort not to get too deep into the weeds planning out specific tactics for achieving goals; we have a great many outstanding volunteers serving on dozens of our committees who do an incredible job of making things happen. The Board tries to focus on overall organizational strategy. Are we going in the right direction? Are there opportunities of which we should be taking better advantage? Are there efforts in which we are currently engaged that may not be yielding outcomes as we expected? To better answer these questions, Dr. Cowl and his team asked all members of the Board of Regents and the Strategic Planning Subcommittee members of the Foundation Board of Trustees, as well as senior CHEST staff, to engage in an environmental scan to take an aggressive look at where we are and where we are headed. The output from our first environmental scan is currently being curated into a list of highest priority items that will be shared with the general membership in the coming months.
A review of our accomplishments over the last 6 months came next. Our new Executive Vice President and Chief Operating Officer, Dr. Robert Musacchio, has superseded all expectations in his first few months in the role. In addition to continuing to push the organization toward the “One CHEST” model by better integrating the Foundation with the College, as well as refining our operating principles in working with industry, Bob is further developing our international reach—exploring collaborations with a number of large international societies and planning meetings abroad later this year (CHEST Congress Thailand and CHEST Regional Congress Athens) and into the next (in Italy, with the regional meeting location to be determined). We are also in the process of recruiting for a new position, Chief Learning Officer, a role that will serve not only to better organize the educational activities of CHEST, but to also serve as a visionary to better imagine what future projects we should be pursuing to be of better service and value to our members.
We took a few moments to recognize the new, incoming Editor in Chief of the journal CHEST®; Peter Mazzone, MD, FCCP, will have some huge shoes to fill in taking the editor’s chair from Richard Irwin, MD, Master FCCP, who has served the journal in this role for more than a decade. Under Dr. Irwin’s leadership, CHEST has been the most-read publication amongst practicing pulmonary specialists; he is also responsible for having launched CHEST’s social media presence, including both video series that integrated directly with the journal (such as Ultrasound Corner) and podcasts. Richard also spoke beautifully about his passion for patient-centered care as a keynote speaker at CHEST 2018. Peter has outlined a number of different areas of focus for the journal in the next year, including putting a high priority on improving the reader experience and crafting an even better web and multimedia presence. We look forward to great things from the journal!
Chris Carroll, MD, FCCP, who chairs CHEST’s Digital Strategy Task Force, presented to the Board on their progress to date. The goal of this group is to evaluate the user experience for CHEST’s content delivery platforms, including the website, apps, and our social media platforms to identify opportunities for improvements that will enable us to better provide our members with on demand, high quality information to improve patient care through a personalized, seamless digital user experience. The team is being co-led by Nicki Augustyn, Senior Vice President for Marketing, Communications, and Publishing, and Ron Moen, Chief Information Officer. We look forward to further updates on this important project.
As I stated in my opening, many of the good things that CHEST does can only happen with the participation of our great members, and so I want to take the time to recognize the NetWorks and everything that they do for the College. In the past year, under the leadership of Council of NetWorks Chairs Hassan Bencheqroun, MD, FCCP, and David Zielinski, MD, FCCP, the NetWorks produced more than 60% of the content at the 2018 CHEST meeting and are actively working on projects ranging from creating educational videos for public consumption to CHEST guidelines proposals and crafting a donor registry for lung transplantation. Our volunteer leaders are our most valuable resource; if you are not currently engaged in the NetWorks, please consider getting involved this spring during the nomination process!
It remains a privilege for the Board to serve this great organization. If you are interested in hearing more, or getting more engaged, please send me an email at [email protected].
David A. Schulman, MD, FCCP
In late January, your Board of Regents met for its first face-to-face quarterly meeting under the leadership of new President Clayton Cowl, MD, MS, FCCP. One of the most valuable aspects of serving on the Board is an opportunity to take an overall look at the direction of the organization. The Board makes a concerted effort not to get too deep into the weeds planning out specific tactics for achieving goals; we have a great many outstanding volunteers serving on dozens of our committees who do an incredible job of making things happen. The Board tries to focus on overall organizational strategy. Are we going in the right direction? Are there opportunities of which we should be taking better advantage? Are there efforts in which we are currently engaged that may not be yielding outcomes as we expected? To better answer these questions, Dr. Cowl and his team asked all members of the Board of Regents and the Strategic Planning Subcommittee members of the Foundation Board of Trustees, as well as senior CHEST staff, to engage in an environmental scan to take an aggressive look at where we are and where we are headed. The output from our first environmental scan is currently being curated into a list of highest priority items that will be shared with the general membership in the coming months.
A review of our accomplishments over the last 6 months came next. Our new Executive Vice President and Chief Operating Officer, Dr. Robert Musacchio, has superseded all expectations in his first few months in the role. In addition to continuing to push the organization toward the “One CHEST” model by better integrating the Foundation with the College, as well as refining our operating principles in working with industry, Bob is further developing our international reach—exploring collaborations with a number of large international societies and planning meetings abroad later this year (CHEST Congress Thailand and CHEST Regional Congress Athens) and into the next (in Italy, with the regional meeting location to be determined). We are also in the process of recruiting for a new position, Chief Learning Officer, a role that will serve not only to better organize the educational activities of CHEST, but to also serve as a visionary to better imagine what future projects we should be pursuing to be of better service and value to our members.
We took a few moments to recognize the new, incoming Editor in Chief of the journal CHEST®; Peter Mazzone, MD, FCCP, will have some huge shoes to fill in taking the editor’s chair from Richard Irwin, MD, Master FCCP, who has served the journal in this role for more than a decade. Under Dr. Irwin’s leadership, CHEST has been the most-read publication amongst practicing pulmonary specialists; he is also responsible for having launched CHEST’s social media presence, including both video series that integrated directly with the journal (such as Ultrasound Corner) and podcasts. Richard also spoke beautifully about his passion for patient-centered care as a keynote speaker at CHEST 2018. Peter has outlined a number of different areas of focus for the journal in the next year, including putting a high priority on improving the reader experience and crafting an even better web and multimedia presence. We look forward to great things from the journal!
Chris Carroll, MD, FCCP, who chairs CHEST’s Digital Strategy Task Force, presented to the Board on their progress to date. The goal of this group is to evaluate the user experience for CHEST’s content delivery platforms, including the website, apps, and our social media platforms to identify opportunities for improvements that will enable us to better provide our members with on demand, high quality information to improve patient care through a personalized, seamless digital user experience. The team is being co-led by Nicki Augustyn, Senior Vice President for Marketing, Communications, and Publishing, and Ron Moen, Chief Information Officer. We look forward to further updates on this important project.
As I stated in my opening, many of the good things that CHEST does can only happen with the participation of our great members, and so I want to take the time to recognize the NetWorks and everything that they do for the College. In the past year, under the leadership of Council of NetWorks Chairs Hassan Bencheqroun, MD, FCCP, and David Zielinski, MD, FCCP, the NetWorks produced more than 60% of the content at the 2018 CHEST meeting and are actively working on projects ranging from creating educational videos for public consumption to CHEST guidelines proposals and crafting a donor registry for lung transplantation. Our volunteer leaders are our most valuable resource; if you are not currently engaged in the NetWorks, please consider getting involved this spring during the nomination process!
It remains a privilege for the Board to serve this great organization. If you are interested in hearing more, or getting more engaged, please send me an email at [email protected].
David A. Schulman, MD, FCCP
Long-term CPAP use not linked to weight gain
Continuous positive airway pressure (CPAP) over several years did not lead to clinically concerning levels of weight gain among patients with obstructive sleep apnea and comorbid cardiovascular disease enrolled in a large international trial, findings from a large, multicenter trial show.
No differences in weight, body mass index (BMI), or other body measurements were found when comparing CPAP and control groups in a post hoc analysis of the Sleep Apnea Cardiovascular Endpoints (SAVE) trial, which included 2,483 adults enrolled at 89 centers in seven countries.
In a subanalysis, there was a small but statistically significant weight gain of less than 400 g in men who used CPAP at least 4 hours per night as compared to matched controls. However, there were no differences in BMI or neck and waist circumferences for these men, and no such changes were observed in women, according to the investigators, led by Qiong Ou, MD, of Guangdong (China) General Hospital and R. Doug McEvoy, MD, of the Adelaide Institute for Sleep Health at Flinders University, Adelaide, Australia.
“Such a small change in weight, even with good adherence over several years, is highly unlikely to have any serious clinical ramifications,” wrote the investigators of the study published in Chest.
“Taken together, these results indicate that long-term CPAP treatment is unlikely to exacerbate the problems of overweight and obesity that are common among patients with OSA,” they added.
In a previous meta-analysis of randomized trials, investigators concluded that CPAP promoted significant increases in BMI and weight. However, the median study duration was only 3 months.
In contrast, the analysis of the SAVE trial included adults who had regular body measurements over a mean follow-up of nearly 4 years.
That long-term follow-up provided an “ideal opportunity” to assess whether CPAP treatment promotes weight gain in OSA patients over the course of several years, the authors of the SAVE trial analysis wrote.
For men in the SAVE trial, the difference in weight change for the CPAP group vs. the control group was just 0.07 kg (95% confidence interval, –0.40 to 0.54; P = .773) while in women, the difference for CPAP vs. controls was –0.14 kg (95% CI, –0.37 to 0.09; P = .233), the investigators reported.
Weight gain was significantly higher among men with good CPAP adherence, defined as use for at least 4 hours per night, investigators said, noting a mean difference of 0.38 kg (95% CI, 0.04-0.73; P = .031), though no other differences were found in body measurements for men, and no such associations were found in women with good CPAP adherence.
It’s not exactly clear why this SAVE analysis would find no evidence of CPAP promoting weight gain over the long term, in contrast to the earlier meta-analysis of short-term studies finding a significant risk of weight gain.
However, it is possible that differences in study populations such as ethnicity, age, or comorbidities contributed to the differences, said investigators.
For example, results of regression analysis in the present study showed that, compared with recruitment in Australia, recruitment in China and India was significantly linked to weight loss, while recruitment in New Zealand was linked to weight gain.
Dr. Ou had no disclosures related to the study, while Dr. McEvoy reported disclosures related to Philips Respironics, ResMed, Fisher & Paykel, Air Liquide, and the National Health and Medical Research Council of Australia.
SOURCE: Ou Q et al. Chest. 2019 Apr;155(4):720-9.
This analysis of the Sleep Apnea Cardiovascular Endpoints (SAVE) trial had several strengths and a reassuring conclusion regarding lack of weight gain with long-term use of CPAP in patients with obstructive sleep apnea (OSA) and comorbid cardiovascular disease. However, the findings may be difficult to extrapolate to Western countries, according to authors of an editorial.
“It is conceivable that the results of the study would have been different if the predominant race of the participants had been Caucasian and had a higher BMI,” said Rohit Budhiraja, MBBS, and Stuart F. Quan, MD, in the editorial. Two-thirds of the patients in the were enrolled in China, the authors said, noting that it is “well established” that Asians with OSA are less often obese compared with Caucasians with OSA in Western countries.
For clinicians, the most important message of this analysis of the SAVE trial should be that weight loss did not occur, according to Dr. Budhiraja and Dr. Quan.
“A comprehensive approach to weight loss should be used, instead of the optimistic view that improved sleep quality and daytime symptoms will automatically translate into increase physical activity, better nutrition and weight loss,” they concluded in their editorial.
Dr. Budhiraja is affiliated with the Brigham and Women’s Hospital, and Harvard Medical School, both in Boston; Dr. Quan is affiliated with Harvard Medical School, Boston, and the University of Arizona Tucson. Their editorial appears in Chest ( 2019 Apr;155[4] 657-8 ). Dr. Budhiraja reported no conflicts of interest. Dr. Quan reported serving as a consultant for Jazz Pharmaceuticals and Best Doctors, along with grant funding from the National Institutes of Health.
This analysis of the Sleep Apnea Cardiovascular Endpoints (SAVE) trial had several strengths and a reassuring conclusion regarding lack of weight gain with long-term use of CPAP in patients with obstructive sleep apnea (OSA) and comorbid cardiovascular disease. However, the findings may be difficult to extrapolate to Western countries, according to authors of an editorial.
“It is conceivable that the results of the study would have been different if the predominant race of the participants had been Caucasian and had a higher BMI,” said Rohit Budhiraja, MBBS, and Stuart F. Quan, MD, in the editorial. Two-thirds of the patients in the were enrolled in China, the authors said, noting that it is “well established” that Asians with OSA are less often obese compared with Caucasians with OSA in Western countries.
For clinicians, the most important message of this analysis of the SAVE trial should be that weight loss did not occur, according to Dr. Budhiraja and Dr. Quan.
“A comprehensive approach to weight loss should be used, instead of the optimistic view that improved sleep quality and daytime symptoms will automatically translate into increase physical activity, better nutrition and weight loss,” they concluded in their editorial.
Dr. Budhiraja is affiliated with the Brigham and Women’s Hospital, and Harvard Medical School, both in Boston; Dr. Quan is affiliated with Harvard Medical School, Boston, and the University of Arizona Tucson. Their editorial appears in Chest ( 2019 Apr;155[4] 657-8 ). Dr. Budhiraja reported no conflicts of interest. Dr. Quan reported serving as a consultant for Jazz Pharmaceuticals and Best Doctors, along with grant funding from the National Institutes of Health.
This analysis of the Sleep Apnea Cardiovascular Endpoints (SAVE) trial had several strengths and a reassuring conclusion regarding lack of weight gain with long-term use of CPAP in patients with obstructive sleep apnea (OSA) and comorbid cardiovascular disease. However, the findings may be difficult to extrapolate to Western countries, according to authors of an editorial.
“It is conceivable that the results of the study would have been different if the predominant race of the participants had been Caucasian and had a higher BMI,” said Rohit Budhiraja, MBBS, and Stuart F. Quan, MD, in the editorial. Two-thirds of the patients in the were enrolled in China, the authors said, noting that it is “well established” that Asians with OSA are less often obese compared with Caucasians with OSA in Western countries.
For clinicians, the most important message of this analysis of the SAVE trial should be that weight loss did not occur, according to Dr. Budhiraja and Dr. Quan.
“A comprehensive approach to weight loss should be used, instead of the optimistic view that improved sleep quality and daytime symptoms will automatically translate into increase physical activity, better nutrition and weight loss,” they concluded in their editorial.
Dr. Budhiraja is affiliated with the Brigham and Women’s Hospital, and Harvard Medical School, both in Boston; Dr. Quan is affiliated with Harvard Medical School, Boston, and the University of Arizona Tucson. Their editorial appears in Chest ( 2019 Apr;155[4] 657-8 ). Dr. Budhiraja reported no conflicts of interest. Dr. Quan reported serving as a consultant for Jazz Pharmaceuticals and Best Doctors, along with grant funding from the National Institutes of Health.
Continuous positive airway pressure (CPAP) over several years did not lead to clinically concerning levels of weight gain among patients with obstructive sleep apnea and comorbid cardiovascular disease enrolled in a large international trial, findings from a large, multicenter trial show.
No differences in weight, body mass index (BMI), or other body measurements were found when comparing CPAP and control groups in a post hoc analysis of the Sleep Apnea Cardiovascular Endpoints (SAVE) trial, which included 2,483 adults enrolled at 89 centers in seven countries.
In a subanalysis, there was a small but statistically significant weight gain of less than 400 g in men who used CPAP at least 4 hours per night as compared to matched controls. However, there were no differences in BMI or neck and waist circumferences for these men, and no such changes were observed in women, according to the investigators, led by Qiong Ou, MD, of Guangdong (China) General Hospital and R. Doug McEvoy, MD, of the Adelaide Institute for Sleep Health at Flinders University, Adelaide, Australia.
“Such a small change in weight, even with good adherence over several years, is highly unlikely to have any serious clinical ramifications,” wrote the investigators of the study published in Chest.
“Taken together, these results indicate that long-term CPAP treatment is unlikely to exacerbate the problems of overweight and obesity that are common among patients with OSA,” they added.
In a previous meta-analysis of randomized trials, investigators concluded that CPAP promoted significant increases in BMI and weight. However, the median study duration was only 3 months.
In contrast, the analysis of the SAVE trial included adults who had regular body measurements over a mean follow-up of nearly 4 years.
That long-term follow-up provided an “ideal opportunity” to assess whether CPAP treatment promotes weight gain in OSA patients over the course of several years, the authors of the SAVE trial analysis wrote.
For men in the SAVE trial, the difference in weight change for the CPAP group vs. the control group was just 0.07 kg (95% confidence interval, –0.40 to 0.54; P = .773) while in women, the difference for CPAP vs. controls was –0.14 kg (95% CI, –0.37 to 0.09; P = .233), the investigators reported.
Weight gain was significantly higher among men with good CPAP adherence, defined as use for at least 4 hours per night, investigators said, noting a mean difference of 0.38 kg (95% CI, 0.04-0.73; P = .031), though no other differences were found in body measurements for men, and no such associations were found in women with good CPAP adherence.
It’s not exactly clear why this SAVE analysis would find no evidence of CPAP promoting weight gain over the long term, in contrast to the earlier meta-analysis of short-term studies finding a significant risk of weight gain.
However, it is possible that differences in study populations such as ethnicity, age, or comorbidities contributed to the differences, said investigators.
For example, results of regression analysis in the present study showed that, compared with recruitment in Australia, recruitment in China and India was significantly linked to weight loss, while recruitment in New Zealand was linked to weight gain.
Dr. Ou had no disclosures related to the study, while Dr. McEvoy reported disclosures related to Philips Respironics, ResMed, Fisher & Paykel, Air Liquide, and the National Health and Medical Research Council of Australia.
SOURCE: Ou Q et al. Chest. 2019 Apr;155(4):720-9.
Continuous positive airway pressure (CPAP) over several years did not lead to clinically concerning levels of weight gain among patients with obstructive sleep apnea and comorbid cardiovascular disease enrolled in a large international trial, findings from a large, multicenter trial show.
No differences in weight, body mass index (BMI), or other body measurements were found when comparing CPAP and control groups in a post hoc analysis of the Sleep Apnea Cardiovascular Endpoints (SAVE) trial, which included 2,483 adults enrolled at 89 centers in seven countries.
In a subanalysis, there was a small but statistically significant weight gain of less than 400 g in men who used CPAP at least 4 hours per night as compared to matched controls. However, there were no differences in BMI or neck and waist circumferences for these men, and no such changes were observed in women, according to the investigators, led by Qiong Ou, MD, of Guangdong (China) General Hospital and R. Doug McEvoy, MD, of the Adelaide Institute for Sleep Health at Flinders University, Adelaide, Australia.
“Such a small change in weight, even with good adherence over several years, is highly unlikely to have any serious clinical ramifications,” wrote the investigators of the study published in Chest.
“Taken together, these results indicate that long-term CPAP treatment is unlikely to exacerbate the problems of overweight and obesity that are common among patients with OSA,” they added.
In a previous meta-analysis of randomized trials, investigators concluded that CPAP promoted significant increases in BMI and weight. However, the median study duration was only 3 months.
In contrast, the analysis of the SAVE trial included adults who had regular body measurements over a mean follow-up of nearly 4 years.
That long-term follow-up provided an “ideal opportunity” to assess whether CPAP treatment promotes weight gain in OSA patients over the course of several years, the authors of the SAVE trial analysis wrote.
For men in the SAVE trial, the difference in weight change for the CPAP group vs. the control group was just 0.07 kg (95% confidence interval, –0.40 to 0.54; P = .773) while in women, the difference for CPAP vs. controls was –0.14 kg (95% CI, –0.37 to 0.09; P = .233), the investigators reported.
Weight gain was significantly higher among men with good CPAP adherence, defined as use for at least 4 hours per night, investigators said, noting a mean difference of 0.38 kg (95% CI, 0.04-0.73; P = .031), though no other differences were found in body measurements for men, and no such associations were found in women with good CPAP adherence.
It’s not exactly clear why this SAVE analysis would find no evidence of CPAP promoting weight gain over the long term, in contrast to the earlier meta-analysis of short-term studies finding a significant risk of weight gain.
However, it is possible that differences in study populations such as ethnicity, age, or comorbidities contributed to the differences, said investigators.
For example, results of regression analysis in the present study showed that, compared with recruitment in Australia, recruitment in China and India was significantly linked to weight loss, while recruitment in New Zealand was linked to weight gain.
Dr. Ou had no disclosures related to the study, while Dr. McEvoy reported disclosures related to Philips Respironics, ResMed, Fisher & Paykel, Air Liquide, and the National Health and Medical Research Council of Australia.
SOURCE: Ou Q et al. Chest. 2019 Apr;155(4):720-9.
FROM CHEST
Nasal testosterone gel preserves fertility in men with hypogonadism
NEW ORLEANS – according to an interim analysis of a postapproval clinical trial.
Testosterone nasal gel is a shorter-acting formulation of testosterone that “can mimic normal physiology,” said John Masterson, MD, a urology resident at the University of Miami. The 4.5% formulation, which was approved by the Food and Drug Administration in 2014 and is marketed as Natesto, delivers 11 mg of testosterone per dose and is dosed three times daily for testosterone replacement therapy.
The negative feedback exerted by other exogenous testosterone formulations on the hypothalamic-pituitary-gonadal (HPG) axis is known to inhibit spermatogenesis, Dr. Masterson said in a video interview at the annual meeting of the Endocrine Society.
Dr. Masterson, senior author Ranjith Ramasamy, MD, and their colleagues hypothesized that the shorter duration of action of testosterone in the nasal gel formulation would result in some conservation of gonadotropin-releasing hormone (GnRH) pulsatility, less inhibition of the HPG axis, and preservation of spermatogenesis.

In the same interview, Dr. Ramasamy, director of reproductive urology at the University of Miami, noted that “the levels of testosterone in men rise about an hour or 2 after administration [of the gel] and seem to drop off about 2 to 4 hours after the peak.” That is closer to normal physiology than other delivery systems in which “the levels of testosterone are pretty high during the day and therefore could lead to some of the side effects that we see with testosterone.”
The phase 4 prospective study enrolled 56 men aged between 18 and 55 years who had low levels of testosterone (baseline mean, 233.97 ng/dL). The mean age was 37 years.
“There are mostly younger men in our study ... and they’re usually coming in with one or two hypogonadal complaints – lack of energy, fatigue, some with erectile dysfunction,” Dr. Masterson explained in the interview. Improvement was seen in those realms, but the differences didn’t reach statistical significance, because baseline quality of life was already fairly high for these otherwise healthy men. “What we can say is that on the drug, quality of life certainly did not get worse,” he said.
At baseline, the mean luteinizing hormone (LH) level was 3.66 IU/mL, and the mean follicle stimulating hormone (FSH) level was 4.01 IU/mL.
Men were eligible to participate if they had two morning blood samples with age-adjusted low testosterone levels, and a total motile sperm count more than 5 million/ejaculation. Participants received 11-mg nasal testosterone gel three times daily for 6 months.
By 1 month into the study, 43 patients had a median testosterone level of 573 ng/dL. Fifteen patients have thus far completed all 6 months of the study and they had a median testosterone level of 604 ng/dL.
At baseline, sperm concentration was a mean 21.32 million/mL with 50% motility, and a total sperm count of 32.23 million/ejaculation. Sperm concentration at 6 months was unchanged at a median 21 million/mL.
Motility was preserved at a median 51.5% after 6 months of therapy, a statistically insignificant difference from 54% motility at baseline. Total motile sperm count decreased from a median 29.3 million/ejaculation at baseline to 19.5 million/ejaculation, a difference that didn’t reach statistical significance.
“What that means is that this nasal testosterone gel [could] be used in men who have low testosterone and are interested in preserving fertility,” said Dr. Masterson.
Dr. Ramasamy said that they’re seeing early confirmation of their initial hypothesis about the nasal gel formulation in this interim analysis. “Because it’s short acting, we believe some of the GnRH pulses and the LH and FSH that are released by the pituitary gland are still maintained, compared with the other forms of testosterone therapy, which can cause complete suppression of the [HPG] axis.”
In discussion with attendees at the poster session at which the research was featured, Dr. Masterson explained that quality-of-life measures were also collected as part of the study and will be presented separately. In addition to information about erectile function, men were asked about libido – a more complex phenomenon than erectile function alone – and early analysis showed a robust response, he said.
He acknowledged that it is not known whether craniofacial circulation facilitates testosterone transport to the brain when the nasal gel testosterone formulation is used, but that it is mechanistically plausible.
Dr. Masterson added that, practically speaking, patients should be aware that the formulation is a gel. “It sort of has to be painted on” the nasal septum within the nostrils, he said.
Aytu BioScience, which markets Natesto, partially supported the study. Dr Masterson reported no disclosures or conflicts of interest.
NEW ORLEANS – according to an interim analysis of a postapproval clinical trial.
Testosterone nasal gel is a shorter-acting formulation of testosterone that “can mimic normal physiology,” said John Masterson, MD, a urology resident at the University of Miami. The 4.5% formulation, which was approved by the Food and Drug Administration in 2014 and is marketed as Natesto, delivers 11 mg of testosterone per dose and is dosed three times daily for testosterone replacement therapy.
The negative feedback exerted by other exogenous testosterone formulations on the hypothalamic-pituitary-gonadal (HPG) axis is known to inhibit spermatogenesis, Dr. Masterson said in a video interview at the annual meeting of the Endocrine Society.
Dr. Masterson, senior author Ranjith Ramasamy, MD, and their colleagues hypothesized that the shorter duration of action of testosterone in the nasal gel formulation would result in some conservation of gonadotropin-releasing hormone (GnRH) pulsatility, less inhibition of the HPG axis, and preservation of spermatogenesis.

In the same interview, Dr. Ramasamy, director of reproductive urology at the University of Miami, noted that “the levels of testosterone in men rise about an hour or 2 after administration [of the gel] and seem to drop off about 2 to 4 hours after the peak.” That is closer to normal physiology than other delivery systems in which “the levels of testosterone are pretty high during the day and therefore could lead to some of the side effects that we see with testosterone.”
The phase 4 prospective study enrolled 56 men aged between 18 and 55 years who had low levels of testosterone (baseline mean, 233.97 ng/dL). The mean age was 37 years.
“There are mostly younger men in our study ... and they’re usually coming in with one or two hypogonadal complaints – lack of energy, fatigue, some with erectile dysfunction,” Dr. Masterson explained in the interview. Improvement was seen in those realms, but the differences didn’t reach statistical significance, because baseline quality of life was already fairly high for these otherwise healthy men. “What we can say is that on the drug, quality of life certainly did not get worse,” he said.
At baseline, the mean luteinizing hormone (LH) level was 3.66 IU/mL, and the mean follicle stimulating hormone (FSH) level was 4.01 IU/mL.
Men were eligible to participate if they had two morning blood samples with age-adjusted low testosterone levels, and a total motile sperm count more than 5 million/ejaculation. Participants received 11-mg nasal testosterone gel three times daily for 6 months.
By 1 month into the study, 43 patients had a median testosterone level of 573 ng/dL. Fifteen patients have thus far completed all 6 months of the study and they had a median testosterone level of 604 ng/dL.
At baseline, sperm concentration was a mean 21.32 million/mL with 50% motility, and a total sperm count of 32.23 million/ejaculation. Sperm concentration at 6 months was unchanged at a median 21 million/mL.
Motility was preserved at a median 51.5% after 6 months of therapy, a statistically insignificant difference from 54% motility at baseline. Total motile sperm count decreased from a median 29.3 million/ejaculation at baseline to 19.5 million/ejaculation, a difference that didn’t reach statistical significance.
“What that means is that this nasal testosterone gel [could] be used in men who have low testosterone and are interested in preserving fertility,” said Dr. Masterson.
Dr. Ramasamy said that they’re seeing early confirmation of their initial hypothesis about the nasal gel formulation in this interim analysis. “Because it’s short acting, we believe some of the GnRH pulses and the LH and FSH that are released by the pituitary gland are still maintained, compared with the other forms of testosterone therapy, which can cause complete suppression of the [HPG] axis.”
In discussion with attendees at the poster session at which the research was featured, Dr. Masterson explained that quality-of-life measures were also collected as part of the study and will be presented separately. In addition to information about erectile function, men were asked about libido – a more complex phenomenon than erectile function alone – and early analysis showed a robust response, he said.
He acknowledged that it is not known whether craniofacial circulation facilitates testosterone transport to the brain when the nasal gel testosterone formulation is used, but that it is mechanistically plausible.
Dr. Masterson added that, practically speaking, patients should be aware that the formulation is a gel. “It sort of has to be painted on” the nasal septum within the nostrils, he said.
Aytu BioScience, which markets Natesto, partially supported the study. Dr Masterson reported no disclosures or conflicts of interest.
NEW ORLEANS – according to an interim analysis of a postapproval clinical trial.
Testosterone nasal gel is a shorter-acting formulation of testosterone that “can mimic normal physiology,” said John Masterson, MD, a urology resident at the University of Miami. The 4.5% formulation, which was approved by the Food and Drug Administration in 2014 and is marketed as Natesto, delivers 11 mg of testosterone per dose and is dosed three times daily for testosterone replacement therapy.
The negative feedback exerted by other exogenous testosterone formulations on the hypothalamic-pituitary-gonadal (HPG) axis is known to inhibit spermatogenesis, Dr. Masterson said in a video interview at the annual meeting of the Endocrine Society.
Dr. Masterson, senior author Ranjith Ramasamy, MD, and their colleagues hypothesized that the shorter duration of action of testosterone in the nasal gel formulation would result in some conservation of gonadotropin-releasing hormone (GnRH) pulsatility, less inhibition of the HPG axis, and preservation of spermatogenesis.

In the same interview, Dr. Ramasamy, director of reproductive urology at the University of Miami, noted that “the levels of testosterone in men rise about an hour or 2 after administration [of the gel] and seem to drop off about 2 to 4 hours after the peak.” That is closer to normal physiology than other delivery systems in which “the levels of testosterone are pretty high during the day and therefore could lead to some of the side effects that we see with testosterone.”
The phase 4 prospective study enrolled 56 men aged between 18 and 55 years who had low levels of testosterone (baseline mean, 233.97 ng/dL). The mean age was 37 years.
“There are mostly younger men in our study ... and they’re usually coming in with one or two hypogonadal complaints – lack of energy, fatigue, some with erectile dysfunction,” Dr. Masterson explained in the interview. Improvement was seen in those realms, but the differences didn’t reach statistical significance, because baseline quality of life was already fairly high for these otherwise healthy men. “What we can say is that on the drug, quality of life certainly did not get worse,” he said.
At baseline, the mean luteinizing hormone (LH) level was 3.66 IU/mL, and the mean follicle stimulating hormone (FSH) level was 4.01 IU/mL.
Men were eligible to participate if they had two morning blood samples with age-adjusted low testosterone levels, and a total motile sperm count more than 5 million/ejaculation. Participants received 11-mg nasal testosterone gel three times daily for 6 months.
By 1 month into the study, 43 patients had a median testosterone level of 573 ng/dL. Fifteen patients have thus far completed all 6 months of the study and they had a median testosterone level of 604 ng/dL.
At baseline, sperm concentration was a mean 21.32 million/mL with 50% motility, and a total sperm count of 32.23 million/ejaculation. Sperm concentration at 6 months was unchanged at a median 21 million/mL.
Motility was preserved at a median 51.5% after 6 months of therapy, a statistically insignificant difference from 54% motility at baseline. Total motile sperm count decreased from a median 29.3 million/ejaculation at baseline to 19.5 million/ejaculation, a difference that didn’t reach statistical significance.
“What that means is that this nasal testosterone gel [could] be used in men who have low testosterone and are interested in preserving fertility,” said Dr. Masterson.
Dr. Ramasamy said that they’re seeing early confirmation of their initial hypothesis about the nasal gel formulation in this interim analysis. “Because it’s short acting, we believe some of the GnRH pulses and the LH and FSH that are released by the pituitary gland are still maintained, compared with the other forms of testosterone therapy, which can cause complete suppression of the [HPG] axis.”
In discussion with attendees at the poster session at which the research was featured, Dr. Masterson explained that quality-of-life measures were also collected as part of the study and will be presented separately. In addition to information about erectile function, men were asked about libido – a more complex phenomenon than erectile function alone – and early analysis showed a robust response, he said.
He acknowledged that it is not known whether craniofacial circulation facilitates testosterone transport to the brain when the nasal gel testosterone formulation is used, but that it is mechanistically plausible.
Dr. Masterson added that, practically speaking, patients should be aware that the formulation is a gel. “It sort of has to be painted on” the nasal septum within the nostrils, he said.
Aytu BioScience, which markets Natesto, partially supported the study. Dr Masterson reported no disclosures or conflicts of interest.
REPORTING FROM ENDO 2019
No biopsy for 21% of adults with celiac disease
Patients with celiac disease often do not receive a biopsy or nutritional recommendations at diagnosis, according to the findings of a large survey study.
Strikingly, 21% of respondents did not have a confirmatory duodenal biopsy, reported Andrew M. Joelson, MD, of Columbia University Medical Center, New York, and his associates. Gastroenterologists diagnosed 66% of biopsied patients but only 31% of nonbiopsied patients (P less than .001). “Patients require more education about management of celiac disease and referral to gastroenterologists for duodenal biopsy confirmation,” the researchers wrote in the May issue of Clinical Gastroenterology and Hepatology.
Classic small-bowel findings in celiac disease (intraepithelial lymphocytes, crypt hyperplasia, and villous atrophy) are not pathognomonic, making serology important for diagnosis. European guidelines discuss forgoing biopsy in children whose antitissue transglutaminase antibody titers are at least 10-fold above the upper limit of normal. However, the American College of Gastroenterology and the American Gastroenterological Association continue to recommend combining serology with confirmatory small bowel biopsy. The extent to which physicians follow this advice is unclear, the researchers noted.
Therefore, they analyzed data from a questionnaire posted on the Celiac Disease Foundation website during a 7-month period in 2016. Among 982 adults with self-reported celiac disease, 780 said their diagnosis included both serology and biopsy and 202 said they received serology only. Only 40% of these nonbiopsied respondents said they sought nutritional counseling at diagnosis, compared with 59% of biopsied patients (P less than .001). Patients diagnosed by serology alone also were more likely to report using dietary supplements to aid gluten digestion (20% vs. 9% of biopsied respondents; P less than .001).
These associations remained statistically significant after adjustment for age and sex, said the researchers. Nonbiopsied patients had a significantly lower odds of having been diagnosed by a gastroenterologist (odds ratio, 0.16; 95% confidence interval, 0.07-0.37) and seeking nutritional counseling (OR, 0.45; 95% CI, 0.33-0.63) and were significantly more likely to use digestive supplements (OR, 2.61; 95%, CI 1.62-4.19).
Fully 87% of respondents always followed a strict gluten-free diet, but symptoms persisted in 65% of those who were not biopsied, compared with only 51% of those who were biopsied. There were too few responses to this question for the difference between groups to reach statistical significance, but the finding might reflect the greater diagnostic accuracy of biopsy, the researchers said. However, they cautioned that none of the associations in this study were necessarily causal, diagnoses were not independently validated, and the reliability of self-reported celiac diagnosis remains unclear.
Survey respondents also were self-selected – for example, 91% self-identified as white and 60% reported having a bachelor’s degree, compared with only about 77% and one-third of adults captured by U.S. Census Bureau data from 2017.
“Although these characteristics may limit the generalizability of our findings, this study nevertheless reflects a population of celiac disease that is not typically studied, such as those not attending large academic celiac disease centers, and those diagnosed without the involvement of a gastroenterologist,” the researchers wrote. “Future studies are warranted to further characterize this population regarding the long-term consequences of forgoing the duodenal biopsy, and to develop educational interventions to promote evidence-based diagnosis and management of celiac disease.”
SOURCE: Joelson AM et al. Clin Gastroenterol Hepatol. 2018 Sep 10. doi: 10.1016/j.cgh.2018.09.006.
Self-reported celiac disease diagnosis is not validated and perhaps more inaccurate now with the rise of other gluten-related disorders. Although misdiagnosis is possible, the finding in this study by Joelson et al. that 21% of self-reported celiac adults said they never had a confirmatory biopsy is remarkable. Another important observation is the low-quality celiac care among nonbiopsed adults, with less formal nutritional counseling and high use of gluten digestive supplements and persistent symptoms.
Nowadays, biopsy confirmation may not be necessary for all. There is strong evidence for nonbiopsy diagnosis in selected symptomatic children with high titers of tissue transglutaminase antibodies (more than 10 times the upper limit of normal) and a positive endomysial antibody in a second sample. Whether the nonbiopsy approach could be applicable also in adults remains controversial. Current guidelines recommend biopsy confirmation in all adults. However, emerging evidence favors celiac disease diagnosis without use of biopsy in selected adults.
Although the debate regarding pros and cons of nonbiopsy diagnosis is far from an end, this approach is here to stay. In the future, regardless of the method selected to confirm celiac disease diagnosis, the overall quality of celiac care should be ensured.
Alberto Rubio-Tapia, MD, is an assistant professor of medicine at the Mayo Clinic, Rochester, Minn. He has no conflicts of interest.
Self-reported celiac disease diagnosis is not validated and perhaps more inaccurate now with the rise of other gluten-related disorders. Although misdiagnosis is possible, the finding in this study by Joelson et al. that 21% of self-reported celiac adults said they never had a confirmatory biopsy is remarkable. Another important observation is the low-quality celiac care among nonbiopsed adults, with less formal nutritional counseling and high use of gluten digestive supplements and persistent symptoms.
Nowadays, biopsy confirmation may not be necessary for all. There is strong evidence for nonbiopsy diagnosis in selected symptomatic children with high titers of tissue transglutaminase antibodies (more than 10 times the upper limit of normal) and a positive endomysial antibody in a second sample. Whether the nonbiopsy approach could be applicable also in adults remains controversial. Current guidelines recommend biopsy confirmation in all adults. However, emerging evidence favors celiac disease diagnosis without use of biopsy in selected adults.
Although the debate regarding pros and cons of nonbiopsy diagnosis is far from an end, this approach is here to stay. In the future, regardless of the method selected to confirm celiac disease diagnosis, the overall quality of celiac care should be ensured.
Alberto Rubio-Tapia, MD, is an assistant professor of medicine at the Mayo Clinic, Rochester, Minn. He has no conflicts of interest.
Self-reported celiac disease diagnosis is not validated and perhaps more inaccurate now with the rise of other gluten-related disorders. Although misdiagnosis is possible, the finding in this study by Joelson et al. that 21% of self-reported celiac adults said they never had a confirmatory biopsy is remarkable. Another important observation is the low-quality celiac care among nonbiopsed adults, with less formal nutritional counseling and high use of gluten digestive supplements and persistent symptoms.
Nowadays, biopsy confirmation may not be necessary for all. There is strong evidence for nonbiopsy diagnosis in selected symptomatic children with high titers of tissue transglutaminase antibodies (more than 10 times the upper limit of normal) and a positive endomysial antibody in a second sample. Whether the nonbiopsy approach could be applicable also in adults remains controversial. Current guidelines recommend biopsy confirmation in all adults. However, emerging evidence favors celiac disease diagnosis without use of biopsy in selected adults.
Although the debate regarding pros and cons of nonbiopsy diagnosis is far from an end, this approach is here to stay. In the future, regardless of the method selected to confirm celiac disease diagnosis, the overall quality of celiac care should be ensured.
Alberto Rubio-Tapia, MD, is an assistant professor of medicine at the Mayo Clinic, Rochester, Minn. He has no conflicts of interest.
Patients with celiac disease often do not receive a biopsy or nutritional recommendations at diagnosis, according to the findings of a large survey study.
Strikingly, 21% of respondents did not have a confirmatory duodenal biopsy, reported Andrew M. Joelson, MD, of Columbia University Medical Center, New York, and his associates. Gastroenterologists diagnosed 66% of biopsied patients but only 31% of nonbiopsied patients (P less than .001). “Patients require more education about management of celiac disease and referral to gastroenterologists for duodenal biopsy confirmation,” the researchers wrote in the May issue of Clinical Gastroenterology and Hepatology.
Classic small-bowel findings in celiac disease (intraepithelial lymphocytes, crypt hyperplasia, and villous atrophy) are not pathognomonic, making serology important for diagnosis. European guidelines discuss forgoing biopsy in children whose antitissue transglutaminase antibody titers are at least 10-fold above the upper limit of normal. However, the American College of Gastroenterology and the American Gastroenterological Association continue to recommend combining serology with confirmatory small bowel biopsy. The extent to which physicians follow this advice is unclear, the researchers noted.
Therefore, they analyzed data from a questionnaire posted on the Celiac Disease Foundation website during a 7-month period in 2016. Among 982 adults with self-reported celiac disease, 780 said their diagnosis included both serology and biopsy and 202 said they received serology only. Only 40% of these nonbiopsied respondents said they sought nutritional counseling at diagnosis, compared with 59% of biopsied patients (P less than .001). Patients diagnosed by serology alone also were more likely to report using dietary supplements to aid gluten digestion (20% vs. 9% of biopsied respondents; P less than .001).
These associations remained statistically significant after adjustment for age and sex, said the researchers. Nonbiopsied patients had a significantly lower odds of having been diagnosed by a gastroenterologist (odds ratio, 0.16; 95% confidence interval, 0.07-0.37) and seeking nutritional counseling (OR, 0.45; 95% CI, 0.33-0.63) and were significantly more likely to use digestive supplements (OR, 2.61; 95%, CI 1.62-4.19).
Fully 87% of respondents always followed a strict gluten-free diet, but symptoms persisted in 65% of those who were not biopsied, compared with only 51% of those who were biopsied. There were too few responses to this question for the difference between groups to reach statistical significance, but the finding might reflect the greater diagnostic accuracy of biopsy, the researchers said. However, they cautioned that none of the associations in this study were necessarily causal, diagnoses were not independently validated, and the reliability of self-reported celiac diagnosis remains unclear.
Survey respondents also were self-selected – for example, 91% self-identified as white and 60% reported having a bachelor’s degree, compared with only about 77% and one-third of adults captured by U.S. Census Bureau data from 2017.
“Although these characteristics may limit the generalizability of our findings, this study nevertheless reflects a population of celiac disease that is not typically studied, such as those not attending large academic celiac disease centers, and those diagnosed without the involvement of a gastroenterologist,” the researchers wrote. “Future studies are warranted to further characterize this population regarding the long-term consequences of forgoing the duodenal biopsy, and to develop educational interventions to promote evidence-based diagnosis and management of celiac disease.”
SOURCE: Joelson AM et al. Clin Gastroenterol Hepatol. 2018 Sep 10. doi: 10.1016/j.cgh.2018.09.006.
Patients with celiac disease often do not receive a biopsy or nutritional recommendations at diagnosis, according to the findings of a large survey study.
Strikingly, 21% of respondents did not have a confirmatory duodenal biopsy, reported Andrew M. Joelson, MD, of Columbia University Medical Center, New York, and his associates. Gastroenterologists diagnosed 66% of biopsied patients but only 31% of nonbiopsied patients (P less than .001). “Patients require more education about management of celiac disease and referral to gastroenterologists for duodenal biopsy confirmation,” the researchers wrote in the May issue of Clinical Gastroenterology and Hepatology.
Classic small-bowel findings in celiac disease (intraepithelial lymphocytes, crypt hyperplasia, and villous atrophy) are not pathognomonic, making serology important for diagnosis. European guidelines discuss forgoing biopsy in children whose antitissue transglutaminase antibody titers are at least 10-fold above the upper limit of normal. However, the American College of Gastroenterology and the American Gastroenterological Association continue to recommend combining serology with confirmatory small bowel biopsy. The extent to which physicians follow this advice is unclear, the researchers noted.
Therefore, they analyzed data from a questionnaire posted on the Celiac Disease Foundation website during a 7-month period in 2016. Among 982 adults with self-reported celiac disease, 780 said their diagnosis included both serology and biopsy and 202 said they received serology only. Only 40% of these nonbiopsied respondents said they sought nutritional counseling at diagnosis, compared with 59% of biopsied patients (P less than .001). Patients diagnosed by serology alone also were more likely to report using dietary supplements to aid gluten digestion (20% vs. 9% of biopsied respondents; P less than .001).
These associations remained statistically significant after adjustment for age and sex, said the researchers. Nonbiopsied patients had a significantly lower odds of having been diagnosed by a gastroenterologist (odds ratio, 0.16; 95% confidence interval, 0.07-0.37) and seeking nutritional counseling (OR, 0.45; 95% CI, 0.33-0.63) and were significantly more likely to use digestive supplements (OR, 2.61; 95%, CI 1.62-4.19).
Fully 87% of respondents always followed a strict gluten-free diet, but symptoms persisted in 65% of those who were not biopsied, compared with only 51% of those who were biopsied. There were too few responses to this question for the difference between groups to reach statistical significance, but the finding might reflect the greater diagnostic accuracy of biopsy, the researchers said. However, they cautioned that none of the associations in this study were necessarily causal, diagnoses were not independently validated, and the reliability of self-reported celiac diagnosis remains unclear.
Survey respondents also were self-selected – for example, 91% self-identified as white and 60% reported having a bachelor’s degree, compared with only about 77% and one-third of adults captured by U.S. Census Bureau data from 2017.
“Although these characteristics may limit the generalizability of our findings, this study nevertheless reflects a population of celiac disease that is not typically studied, such as those not attending large academic celiac disease centers, and those diagnosed without the involvement of a gastroenterologist,” the researchers wrote. “Future studies are warranted to further characterize this population regarding the long-term consequences of forgoing the duodenal biopsy, and to develop educational interventions to promote evidence-based diagnosis and management of celiac disease.”
SOURCE: Joelson AM et al. Clin Gastroenterol Hepatol. 2018 Sep 10. doi: 10.1016/j.cgh.2018.09.006.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
CT scan honeycombing key to hypersensitivity pneumonitis prognosis
In patients with hypersensitivity pneumonitis, presence of radiologic honeycombing suggests a poor prognosis in line with what might be expected with idiopathic pulmonary fibrosis, results of a recent study suggest.
When radiologic honeycombing was present, event-free survival was uniformly poor, regardless of whether the patient had hypersensitivity pneumonitis (HP) or idiopathic pulmonary fibrosis (IPF). By contrast, HP patients with nonhoneycomb fibrosis had longer event-free survival than IPF patients with honeycomb features on CT, wrote researchers led by Margaret L. Salisbury, MD, of the division of pulmonary and critical care medicine at the University of Michigan, Ann Arbor.
“Given the uniformly poor outcome among subjects with radiologic honeycombing, pursuit of invasive diagnostic tests directed at differentiating IPF from HP may be of limited value,” Dr. Salisbury and her coinvestigators wrote in Chest.
In the study, 117 patients with HP and 161 with IPF underwent high-resolution CT, results of which were evaluated by three thoracic radiologists. Patients with HP who had no fibrosis on CT had the best event-free median survival, or time to transplant or death, at greater than 14.73 years. For HP patients with nonhoneycomb fibrosis, that median survival was greater than 7.95 years, compared with just 5.20 years in IPF patients without honeycomb features.
Looking specifically at patients with honeycomb features, median event-free survival was poor for both HP and IPF patients, at 2.76 and 2.81 years, respectively.
The HP patients with no fibrosis had a significant improvement in percent predicted forced vital capacity over time, while fibrotic patients experienced significant declines, the investigators wrote. Thus, HP patients with nonhoneycomb fibrosis had forced vital capacity declines despite longer transplant-free survival.
“These results highlight the importance of making a correct diagnosis of HP versus IPF in patients with nonhoneycomb fibrosis, as well as the limited utility in differentiating HP from IPF among patients with radiologic honeycombing,” Dr. Salisbury and her coinvestigators concluded.
Dr. Salisbury reported grants from the National Institutes of Health during the study. Her coauthors reported disclosures related to the NIH, Bayer, Centocor, Gilead, Promedior, Ikaria, Genentech, Nycomed/Takeda, Pfizer, and others.
SOURCE: Salisbury ML et al. Chest. 2019 Apr;155(4):699-711.
This study provides “clearly defined” phenotypes that are practical and potentially important for stratification and prognosis in patients with hypersensitivity pneumonitis (HP), according to David A. Lynch, MB.
“They should be widely adopted,” Dr. Lynch wrote of the three HP CT phenotypes in an editorial.
The study adds further evidence on the significance of honeycombing in the clinical course of fibrotic HP versus that of idiopathic pulmonary fibrosis, he added. Symptom duration in the HP patients was similar regardless of nonfibrotic, fibrotic, or honeycomb patterns, and was not linked to survival time. With that in mind, classifying HP based on fibrosis and its pattern may be more useful in determining prognosis than traditional acute, subacute, or chronic classification
That said, the present study does not provide much information on what demographic or exposure factors were associated with three phenotypes.
“Further study of this question will be important,” Dr. Lynch wrote. “Additionally, it will be important to understand the histologic correlates of the CT phenotypes.”
Dr. Lynch is with the department of radiology at National Jewish Health in Denver. His remarks are taken from his editorial that appeared in Chest (2019;155[4]:655-6). Dr. Lynch reported disclosures related to Genentech, Boehringer Ingelheim, Veracyte, Boehringer Ingelheim, and the France Foundation.
This study provides “clearly defined” phenotypes that are practical and potentially important for stratification and prognosis in patients with hypersensitivity pneumonitis (HP), according to David A. Lynch, MB.
“They should be widely adopted,” Dr. Lynch wrote of the three HP CT phenotypes in an editorial.
The study adds further evidence on the significance of honeycombing in the clinical course of fibrotic HP versus that of idiopathic pulmonary fibrosis, he added. Symptom duration in the HP patients was similar regardless of nonfibrotic, fibrotic, or honeycomb patterns, and was not linked to survival time. With that in mind, classifying HP based on fibrosis and its pattern may be more useful in determining prognosis than traditional acute, subacute, or chronic classification
That said, the present study does not provide much information on what demographic or exposure factors were associated with three phenotypes.
“Further study of this question will be important,” Dr. Lynch wrote. “Additionally, it will be important to understand the histologic correlates of the CT phenotypes.”
Dr. Lynch is with the department of radiology at National Jewish Health in Denver. His remarks are taken from his editorial that appeared in Chest (2019;155[4]:655-6). Dr. Lynch reported disclosures related to Genentech, Boehringer Ingelheim, Veracyte, Boehringer Ingelheim, and the France Foundation.
This study provides “clearly defined” phenotypes that are practical and potentially important for stratification and prognosis in patients with hypersensitivity pneumonitis (HP), according to David A. Lynch, MB.
“They should be widely adopted,” Dr. Lynch wrote of the three HP CT phenotypes in an editorial.
The study adds further evidence on the significance of honeycombing in the clinical course of fibrotic HP versus that of idiopathic pulmonary fibrosis, he added. Symptom duration in the HP patients was similar regardless of nonfibrotic, fibrotic, or honeycomb patterns, and was not linked to survival time. With that in mind, classifying HP based on fibrosis and its pattern may be more useful in determining prognosis than traditional acute, subacute, or chronic classification
That said, the present study does not provide much information on what demographic or exposure factors were associated with three phenotypes.
“Further study of this question will be important,” Dr. Lynch wrote. “Additionally, it will be important to understand the histologic correlates of the CT phenotypes.”
Dr. Lynch is with the department of radiology at National Jewish Health in Denver. His remarks are taken from his editorial that appeared in Chest (2019;155[4]:655-6). Dr. Lynch reported disclosures related to Genentech, Boehringer Ingelheim, Veracyte, Boehringer Ingelheim, and the France Foundation.
In patients with hypersensitivity pneumonitis, presence of radiologic honeycombing suggests a poor prognosis in line with what might be expected with idiopathic pulmonary fibrosis, results of a recent study suggest.
When radiologic honeycombing was present, event-free survival was uniformly poor, regardless of whether the patient had hypersensitivity pneumonitis (HP) or idiopathic pulmonary fibrosis (IPF). By contrast, HP patients with nonhoneycomb fibrosis had longer event-free survival than IPF patients with honeycomb features on CT, wrote researchers led by Margaret L. Salisbury, MD, of the division of pulmonary and critical care medicine at the University of Michigan, Ann Arbor.
“Given the uniformly poor outcome among subjects with radiologic honeycombing, pursuit of invasive diagnostic tests directed at differentiating IPF from HP may be of limited value,” Dr. Salisbury and her coinvestigators wrote in Chest.
In the study, 117 patients with HP and 161 with IPF underwent high-resolution CT, results of which were evaluated by three thoracic radiologists. Patients with HP who had no fibrosis on CT had the best event-free median survival, or time to transplant or death, at greater than 14.73 years. For HP patients with nonhoneycomb fibrosis, that median survival was greater than 7.95 years, compared with just 5.20 years in IPF patients without honeycomb features.
Looking specifically at patients with honeycomb features, median event-free survival was poor for both HP and IPF patients, at 2.76 and 2.81 years, respectively.
The HP patients with no fibrosis had a significant improvement in percent predicted forced vital capacity over time, while fibrotic patients experienced significant declines, the investigators wrote. Thus, HP patients with nonhoneycomb fibrosis had forced vital capacity declines despite longer transplant-free survival.
“These results highlight the importance of making a correct diagnosis of HP versus IPF in patients with nonhoneycomb fibrosis, as well as the limited utility in differentiating HP from IPF among patients with radiologic honeycombing,” Dr. Salisbury and her coinvestigators concluded.
Dr. Salisbury reported grants from the National Institutes of Health during the study. Her coauthors reported disclosures related to the NIH, Bayer, Centocor, Gilead, Promedior, Ikaria, Genentech, Nycomed/Takeda, Pfizer, and others.
SOURCE: Salisbury ML et al. Chest. 2019 Apr;155(4):699-711.
In patients with hypersensitivity pneumonitis, presence of radiologic honeycombing suggests a poor prognosis in line with what might be expected with idiopathic pulmonary fibrosis, results of a recent study suggest.
When radiologic honeycombing was present, event-free survival was uniformly poor, regardless of whether the patient had hypersensitivity pneumonitis (HP) or idiopathic pulmonary fibrosis (IPF). By contrast, HP patients with nonhoneycomb fibrosis had longer event-free survival than IPF patients with honeycomb features on CT, wrote researchers led by Margaret L. Salisbury, MD, of the division of pulmonary and critical care medicine at the University of Michigan, Ann Arbor.
“Given the uniformly poor outcome among subjects with radiologic honeycombing, pursuit of invasive diagnostic tests directed at differentiating IPF from HP may be of limited value,” Dr. Salisbury and her coinvestigators wrote in Chest.
In the study, 117 patients with HP and 161 with IPF underwent high-resolution CT, results of which were evaluated by three thoracic radiologists. Patients with HP who had no fibrosis on CT had the best event-free median survival, or time to transplant or death, at greater than 14.73 years. For HP patients with nonhoneycomb fibrosis, that median survival was greater than 7.95 years, compared with just 5.20 years in IPF patients without honeycomb features.
Looking specifically at patients with honeycomb features, median event-free survival was poor for both HP and IPF patients, at 2.76 and 2.81 years, respectively.
The HP patients with no fibrosis had a significant improvement in percent predicted forced vital capacity over time, while fibrotic patients experienced significant declines, the investigators wrote. Thus, HP patients with nonhoneycomb fibrosis had forced vital capacity declines despite longer transplant-free survival.
“These results highlight the importance of making a correct diagnosis of HP versus IPF in patients with nonhoneycomb fibrosis, as well as the limited utility in differentiating HP from IPF among patients with radiologic honeycombing,” Dr. Salisbury and her coinvestigators concluded.
Dr. Salisbury reported grants from the National Institutes of Health during the study. Her coauthors reported disclosures related to the NIH, Bayer, Centocor, Gilead, Promedior, Ikaria, Genentech, Nycomed/Takeda, Pfizer, and others.
SOURCE: Salisbury ML et al. Chest. 2019 Apr;155(4):699-711.
FROM CHEST®
Look for alcohol septal ablation in the next HOCM guideline
SNOWMASS, COLO. – Recent data on long-term outcomes of alcohol septal ablation for hypertrophic obstructive cardiomyopathy are “quite favorable” and will be considered in the deliberations of the task force charged with revising the 2011 American College of Cardiology/American Heart Association guidelines.
Paul Sorajja, MD, a member of the task force and director of the Center of Valve and Structural Heart Disease at the Minneapolis Heart Institute, explained that the 2011 ACC/AHA guidelines on hypertrophic cardiomyopathy took an appropriately cautious stance regarding alcohol septal ablation (ASA) in light of a 2010 Dutch report warning of an increased risk of sudden cardiac death following the procedure (Circ Heart Fail. 2010 May;3[3]:362-9) and a dearth of evidence to the contrary.
The 2011 guidelines recommend surgical myectomy performed in an experienced center as the class I treatment of choice for patients with severely symptomatic, drug-refractory hypertrophic obstructive cardiomyopathy (HOCM). ASA gets a class IIa recommendation for patients at high surgical risk, and is class III – meaning don’t do it – for patients under age 40 years if myectomy is a viable option (J Am Coll Cardiol. 2011 Dec 13;58[25]:e212-60), Dr. Sorajja noted at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
However, the cautionary Dutch study that influenced the 2011 guidelines is considered controversial, he explained. It was small – just 91 patients – and the operators used twice the normal volume of alcohol, with a resultant much larger, potentially arrhythmogenic myocardial ablation scar. So, many experts have been eagerly awaiting additional long-term studies. And that long-sought data has recently been piling up. Since the 2011 guidelines, six long-term studies have been published, including one led by Dr. Sorajja (Circulation. 2012 Nov 13;126[20]:2374-80). The results have been consistently favorable, with 5-year survival rates of 87%-96%, in line with rates in the general population.
The largest of these studies included 1,197 patients who underwent ASA at seven centers in four European countries. The 30-day mortality and pacemaker implantation rates were significantly lower in patients aged up to 50 years, compared with those aged 65 and up. The annual mortality rate during a mean follow-up of 5.4 years was 1% in patients age 50 years and younger, 2.1% in those aged 51-64, and 5.1% in the oldest group. Arrhythmic events occurred at a rate of about 1% per year in all three age groups. And 95% of patients in the youngest group were in New York Heart Association class I or II at last follow-up (JACC Cardiovasc Interv. 2017 Jun 12;10[11]:1134-43).
In an accompanying editorial, Michael A. Fifer, MD, of Massachusetts General Hospital, Boston, commented that “high-volume surgical myectomy centers are few and far between” and there is “a clear inverse relation between [surgical] procedure volume and outcomes.”
The study “provides the most robust data to date regarding the outcomes of ASA in younger patients, precisely the type of data that were missing at the time of writing of the ACCF/AHA and European Society of Cardiology guidelines. Given the favorable outcomes of ASA in this age group, and the unavailability of high-volume myectomy programs in many geographic regions, the time has come to liberalize the indication for ASA in younger patients,” declared Dr. Fifer (JACC Cardiovasc Interv. 2017 Jun 12;10[11]:1144-6).
The second-largest long-term study of ASA was a recent report on 952 German patients with a minimum 6-year follow-up. The estimated 5-, 10-, and 15-year survival rates were 95.8%, 88.3%, and 79.7%, respectively. Estimated survival free of cardiac events was 98.9% at 5 years, 97.0% at 10 years, and 96.5% at 15 years. About 5% of patients received an implantable cardioverter defibrillator.
The investigators concluded, “In this study, PTSMA [percutaneous transluminal septal myocardial ablation] could be proofed as a safe procedure with ongoing symptomatic improvement and excellent long-term survival. Therefore, PTSMA is a reasonable alternative to surgical myectomy in HOCM.” (J Am Coll Cardiol. 2018 Dec 18;72[24]:3087-94) It’s way too early in the ACC/AHA guideline revision process to say what the new recommendations will be, according to Dr. Sorajja.
One unsettled issue, in his view, is whether ASA outcomes are significantly better in high-volume centers. A study of all 11,248 patients who underwent surgical myectomy of ASA during 2003-2011 in a large U.S. inpatient database concluded that undergoing surgical myectomy in a bottom-tertile-volume hospital was independently associated with an adjusted 210% increased risk of inpatient all-cause mortality and a 280% increased risk of bleeding, but that being in the lowest tertile of ASA hospital volume wasn’t independently associated with increased risk after adjustment for potential confounders (JAMA Cardiol. 2016 Jun 1;1:[3]:324-32).
However, Dr. Sorajja indicated he didn’t find the statistically adjusted results in the ASA cohort persuasive.
“I will tell you that the favorable results in the long-term studies came from hospitals in the highest-volume tertile,” the cardiologist said.
At present, he considers surgical myectomy the gold standard therapy. With well-selected patients for ASA – that is, those for whom imaging has identified an appropriate septal artery for delivery of the alcohol, along with no more than 24 mm of septal hypertrophy so the alcohol dose can be limited to a maximum of 20-25 cc – it’s reasonable to expect gradient relief in more than 90% of patients, surgical-like results with optimal relief of left ventricular outflow tract obstruction and a residual gradient of less than 10 mm Hg in about 75%, and a procedural mortality of about 1%, he said.
Dr. Sorajja reported receiving research funding from Abbott Structural, Boston Scientific, Edwards Lifesciences, and Medtronic, and serving as a consultant to those companies and several others.
SNOWMASS, COLO. – Recent data on long-term outcomes of alcohol septal ablation for hypertrophic obstructive cardiomyopathy are “quite favorable” and will be considered in the deliberations of the task force charged with revising the 2011 American College of Cardiology/American Heart Association guidelines.
Paul Sorajja, MD, a member of the task force and director of the Center of Valve and Structural Heart Disease at the Minneapolis Heart Institute, explained that the 2011 ACC/AHA guidelines on hypertrophic cardiomyopathy took an appropriately cautious stance regarding alcohol septal ablation (ASA) in light of a 2010 Dutch report warning of an increased risk of sudden cardiac death following the procedure (Circ Heart Fail. 2010 May;3[3]:362-9) and a dearth of evidence to the contrary.
The 2011 guidelines recommend surgical myectomy performed in an experienced center as the class I treatment of choice for patients with severely symptomatic, drug-refractory hypertrophic obstructive cardiomyopathy (HOCM). ASA gets a class IIa recommendation for patients at high surgical risk, and is class III – meaning don’t do it – for patients under age 40 years if myectomy is a viable option (J Am Coll Cardiol. 2011 Dec 13;58[25]:e212-60), Dr. Sorajja noted at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
However, the cautionary Dutch study that influenced the 2011 guidelines is considered controversial, he explained. It was small – just 91 patients – and the operators used twice the normal volume of alcohol, with a resultant much larger, potentially arrhythmogenic myocardial ablation scar. So, many experts have been eagerly awaiting additional long-term studies. And that long-sought data has recently been piling up. Since the 2011 guidelines, six long-term studies have been published, including one led by Dr. Sorajja (Circulation. 2012 Nov 13;126[20]:2374-80). The results have been consistently favorable, with 5-year survival rates of 87%-96%, in line with rates in the general population.
The largest of these studies included 1,197 patients who underwent ASA at seven centers in four European countries. The 30-day mortality and pacemaker implantation rates were significantly lower in patients aged up to 50 years, compared with those aged 65 and up. The annual mortality rate during a mean follow-up of 5.4 years was 1% in patients age 50 years and younger, 2.1% in those aged 51-64, and 5.1% in the oldest group. Arrhythmic events occurred at a rate of about 1% per year in all three age groups. And 95% of patients in the youngest group were in New York Heart Association class I or II at last follow-up (JACC Cardiovasc Interv. 2017 Jun 12;10[11]:1134-43).
In an accompanying editorial, Michael A. Fifer, MD, of Massachusetts General Hospital, Boston, commented that “high-volume surgical myectomy centers are few and far between” and there is “a clear inverse relation between [surgical] procedure volume and outcomes.”
The study “provides the most robust data to date regarding the outcomes of ASA in younger patients, precisely the type of data that were missing at the time of writing of the ACCF/AHA and European Society of Cardiology guidelines. Given the favorable outcomes of ASA in this age group, and the unavailability of high-volume myectomy programs in many geographic regions, the time has come to liberalize the indication for ASA in younger patients,” declared Dr. Fifer (JACC Cardiovasc Interv. 2017 Jun 12;10[11]:1144-6).
The second-largest long-term study of ASA was a recent report on 952 German patients with a minimum 6-year follow-up. The estimated 5-, 10-, and 15-year survival rates were 95.8%, 88.3%, and 79.7%, respectively. Estimated survival free of cardiac events was 98.9% at 5 years, 97.0% at 10 years, and 96.5% at 15 years. About 5% of patients received an implantable cardioverter defibrillator.
The investigators concluded, “In this study, PTSMA [percutaneous transluminal septal myocardial ablation] could be proofed as a safe procedure with ongoing symptomatic improvement and excellent long-term survival. Therefore, PTSMA is a reasonable alternative to surgical myectomy in HOCM.” (J Am Coll Cardiol. 2018 Dec 18;72[24]:3087-94) It’s way too early in the ACC/AHA guideline revision process to say what the new recommendations will be, according to Dr. Sorajja.
One unsettled issue, in his view, is whether ASA outcomes are significantly better in high-volume centers. A study of all 11,248 patients who underwent surgical myectomy of ASA during 2003-2011 in a large U.S. inpatient database concluded that undergoing surgical myectomy in a bottom-tertile-volume hospital was independently associated with an adjusted 210% increased risk of inpatient all-cause mortality and a 280% increased risk of bleeding, but that being in the lowest tertile of ASA hospital volume wasn’t independently associated with increased risk after adjustment for potential confounders (JAMA Cardiol. 2016 Jun 1;1:[3]:324-32).
However, Dr. Sorajja indicated he didn’t find the statistically adjusted results in the ASA cohort persuasive.
“I will tell you that the favorable results in the long-term studies came from hospitals in the highest-volume tertile,” the cardiologist said.
At present, he considers surgical myectomy the gold standard therapy. With well-selected patients for ASA – that is, those for whom imaging has identified an appropriate septal artery for delivery of the alcohol, along with no more than 24 mm of septal hypertrophy so the alcohol dose can be limited to a maximum of 20-25 cc – it’s reasonable to expect gradient relief in more than 90% of patients, surgical-like results with optimal relief of left ventricular outflow tract obstruction and a residual gradient of less than 10 mm Hg in about 75%, and a procedural mortality of about 1%, he said.
Dr. Sorajja reported receiving research funding from Abbott Structural, Boston Scientific, Edwards Lifesciences, and Medtronic, and serving as a consultant to those companies and several others.
SNOWMASS, COLO. – Recent data on long-term outcomes of alcohol septal ablation for hypertrophic obstructive cardiomyopathy are “quite favorable” and will be considered in the deliberations of the task force charged with revising the 2011 American College of Cardiology/American Heart Association guidelines.
Paul Sorajja, MD, a member of the task force and director of the Center of Valve and Structural Heart Disease at the Minneapolis Heart Institute, explained that the 2011 ACC/AHA guidelines on hypertrophic cardiomyopathy took an appropriately cautious stance regarding alcohol septal ablation (ASA) in light of a 2010 Dutch report warning of an increased risk of sudden cardiac death following the procedure (Circ Heart Fail. 2010 May;3[3]:362-9) and a dearth of evidence to the contrary.
The 2011 guidelines recommend surgical myectomy performed in an experienced center as the class I treatment of choice for patients with severely symptomatic, drug-refractory hypertrophic obstructive cardiomyopathy (HOCM). ASA gets a class IIa recommendation for patients at high surgical risk, and is class III – meaning don’t do it – for patients under age 40 years if myectomy is a viable option (J Am Coll Cardiol. 2011 Dec 13;58[25]:e212-60), Dr. Sorajja noted at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
However, the cautionary Dutch study that influenced the 2011 guidelines is considered controversial, he explained. It was small – just 91 patients – and the operators used twice the normal volume of alcohol, with a resultant much larger, potentially arrhythmogenic myocardial ablation scar. So, many experts have been eagerly awaiting additional long-term studies. And that long-sought data has recently been piling up. Since the 2011 guidelines, six long-term studies have been published, including one led by Dr. Sorajja (Circulation. 2012 Nov 13;126[20]:2374-80). The results have been consistently favorable, with 5-year survival rates of 87%-96%, in line with rates in the general population.
The largest of these studies included 1,197 patients who underwent ASA at seven centers in four European countries. The 30-day mortality and pacemaker implantation rates were significantly lower in patients aged up to 50 years, compared with those aged 65 and up. The annual mortality rate during a mean follow-up of 5.4 years was 1% in patients age 50 years and younger, 2.1% in those aged 51-64, and 5.1% in the oldest group. Arrhythmic events occurred at a rate of about 1% per year in all three age groups. And 95% of patients in the youngest group were in New York Heart Association class I or II at last follow-up (JACC Cardiovasc Interv. 2017 Jun 12;10[11]:1134-43).
In an accompanying editorial, Michael A. Fifer, MD, of Massachusetts General Hospital, Boston, commented that “high-volume surgical myectomy centers are few and far between” and there is “a clear inverse relation between [surgical] procedure volume and outcomes.”
The study “provides the most robust data to date regarding the outcomes of ASA in younger patients, precisely the type of data that were missing at the time of writing of the ACCF/AHA and European Society of Cardiology guidelines. Given the favorable outcomes of ASA in this age group, and the unavailability of high-volume myectomy programs in many geographic regions, the time has come to liberalize the indication for ASA in younger patients,” declared Dr. Fifer (JACC Cardiovasc Interv. 2017 Jun 12;10[11]:1144-6).
The second-largest long-term study of ASA was a recent report on 952 German patients with a minimum 6-year follow-up. The estimated 5-, 10-, and 15-year survival rates were 95.8%, 88.3%, and 79.7%, respectively. Estimated survival free of cardiac events was 98.9% at 5 years, 97.0% at 10 years, and 96.5% at 15 years. About 5% of patients received an implantable cardioverter defibrillator.
The investigators concluded, “In this study, PTSMA [percutaneous transluminal septal myocardial ablation] could be proofed as a safe procedure with ongoing symptomatic improvement and excellent long-term survival. Therefore, PTSMA is a reasonable alternative to surgical myectomy in HOCM.” (J Am Coll Cardiol. 2018 Dec 18;72[24]:3087-94) It’s way too early in the ACC/AHA guideline revision process to say what the new recommendations will be, according to Dr. Sorajja.
One unsettled issue, in his view, is whether ASA outcomes are significantly better in high-volume centers. A study of all 11,248 patients who underwent surgical myectomy of ASA during 2003-2011 in a large U.S. inpatient database concluded that undergoing surgical myectomy in a bottom-tertile-volume hospital was independently associated with an adjusted 210% increased risk of inpatient all-cause mortality and a 280% increased risk of bleeding, but that being in the lowest tertile of ASA hospital volume wasn’t independently associated with increased risk after adjustment for potential confounders (JAMA Cardiol. 2016 Jun 1;1:[3]:324-32).
However, Dr. Sorajja indicated he didn’t find the statistically adjusted results in the ASA cohort persuasive.
“I will tell you that the favorable results in the long-term studies came from hospitals in the highest-volume tertile,” the cardiologist said.
At present, he considers surgical myectomy the gold standard therapy. With well-selected patients for ASA – that is, those for whom imaging has identified an appropriate septal artery for delivery of the alcohol, along with no more than 24 mm of septal hypertrophy so the alcohol dose can be limited to a maximum of 20-25 cc – it’s reasonable to expect gradient relief in more than 90% of patients, surgical-like results with optimal relief of left ventricular outflow tract obstruction and a residual gradient of less than 10 mm Hg in about 75%, and a procedural mortality of about 1%, he said.
Dr. Sorajja reported receiving research funding from Abbott Structural, Boston Scientific, Edwards Lifesciences, and Medtronic, and serving as a consultant to those companies and several others.
EXPERT ANALYSIS FROM ACC SNOWMASS 2019




