Patients with Crohn’s disease who experienced complete endoscopic healing with biologic therapy had significantly lower subsequent rates of treatment failure, intestinal resection, and hospitalization, compared with patients who experienced only partial mucosal healing, according to the findings of a two-center retrospective study.

Over a median of 4.8 years of follow-up (interquartile range, 2.1-7.2 years) rates of treatment failure were 25% in patients with complete mucosal healing at baseline (that is, a Crohn’s Disease Endoscopic Index of Severity [CDEIS] score of 0) and 48% in patients with partial healing (CDEIS score greater than 0 but less than 4). The difference was statistically significant (P = .045). No patient with a baseline CDEIS score of 0 required intestinal resection, compared with 11% of patients with scores greater than 0 but less than 4 (P = .031). Rates of hospitalization because of Crohn’s disease were 3.5% versus 18.5%, respectively (P = .013). Clara Yzet, MD, of Amiens (France) University Hospital, Université de Picardie Jules Verne, reported the findings together with her associates in Clinical Gastroenterology and Hepatology.

Mucosal healing is a key therapeutic target in Crohn’s disease that has been linked to desirable outcomes, such as steroid-free remission and a lower rate of intestinal resection. However, prior observational studies have inconsistently defined mucosal healing, and clinical trials of biologics have used any of at least seven different definitions, the researchers wrote. Recently, in patients with ulcerative colitis, a Scandinavian Journal of Gastroenterology and another in the Journal of Crohn’s and Colitis linked a stricter definition of mucosal healing (an endoscopic Mayo score of 0, or histologic healing) with superior long-term clinical outcomes. In patients with Crohn’s disease, however, there has been no established threshold for mucosal healing based on either the CDEIS or the Simplified Endoscopic Score for Crohn’s disease (SES-CD).

Therefore, Dr. Yzet and her associates identified and reviewed the medical records of 84 consecutive adults with clinically remitted Crohn’s disease who received anti–tumor necrosis factor therapies (infliximab and adalimumab) or vedolizumab at two university hospitals in France between 2008 and 2015. All patients received baseline and follow-up colonoscopies, with results scored on the CDEIS. In all cases, the second CDEIS score was less than 4 (the CDEIS ranges from 0 to 44). The primary outcome was treatment failure, defined as the need for biologic optimization (increasing the dose or shortening the dosing interval of the biologic), corticosteroids, or immunosuppressants; a Harvey-Bradshaw score greater than 4 associated with a change in treatment; or the need for intestinal resection or hospitalization because of Crohn’s disease.

At baseline, 57 patients had CDEIS scores of 0 (complete mucosal healing) and 27 patients had scores greater than 0 but less than 4 (partial mucosal healing). The two groups were otherwise similar except that patients with complete mucosal healing had a shorter median duration of Crohn’s disease (10.3 vs. 15.1 years in the partial healing group; P = .029) and a lower prevalence of Crohn’s disease phenotype B2 (stricturing) according to the Vienna classification (1.8% vs. 14.8%; P = .035). In the multivariate analysis, CDEIS score was the only factor associated with treatment failure (hazard ratio, 2.61; 95% confidence interval, 1.16-5.88; P = .02).

“Our findings suggest that we should be more ambitious in clinical practice to change patients’ life and disease course by achieving complete endoscopic healing. However, this strategy could be limited by the ability of current drugs to achieve complete mucosal healing,” the researchers wrote. “Obtaining a complete mucosal healing would require today a significant need for optimization or change of biologics.”

No external funding sources were reported. Two coinvestigators disclosed ties to AbbVie, Amgen, Biogaran, Biogen, Ferring, Janssen, MSD, Pfizer, Takeda, and several other pharmaceutical companies. The remaining investigators reported having no relevant conflicts of interest.

SOURCE: Yzet C et al. Clin Gastroenterol Hepatol. 2019 Nov 16. doi: 10.1016/j.cgh.2019.11.025.
 

Patients with Crohn’s disease who experienced complete endoscopic healing with biologic therapy had significantly lower subsequent rates of treatment failure, intestinal resection, and hospitalization, compared with patients who experienced only partial mucosal healing, according to the findings of a two-center retrospective study.

Over a median of 4.8 years of follow-up (interquartile range, 2.1-7.2 years) rates of treatment failure were 25% in patients with complete mucosal healing at baseline (that is, a Crohn’s Disease Endoscopic Index of Severity [CDEIS] score of 0) and 48% in patients with partial healing (CDEIS score greater than 0 but less than 4). The difference was statistically significant (P = .045). No patient with a baseline CDEIS score of 0 required intestinal resection, compared with 11% of patients with scores greater than 0 but less than 4 (P = .031). Rates of hospitalization because of Crohn’s disease were 3.5% versus 18.5%, respectively (P = .013). Clara Yzet, MD, of Amiens (France) University Hospital, Université de Picardie Jules Verne, reported the findings together with her associates in Clinical Gastroenterology and Hepatology.

Mucosal healing is a key therapeutic target in Crohn’s disease that has been linked to desirable outcomes, such as steroid-free remission and a lower rate of intestinal resection. However, prior observational studies have inconsistently defined mucosal healing, and clinical trials of biologics have used any of at least seven different definitions, the researchers wrote. Recently, in patients with ulcerative colitis, a Scandinavian Journal of Gastroenterology and another in the Journal of Crohn’s and Colitis linked a stricter definition of mucosal healing (an endoscopic Mayo score of 0, or histologic healing) with superior long-term clinical outcomes. In patients with Crohn’s disease, however, there has been no established threshold for mucosal healing based on either the CDEIS or the Simplified Endoscopic Score for Crohn’s disease (SES-CD).

Therefore, Dr. Yzet and her associates identified and reviewed the medical records of 84 consecutive adults with clinically remitted Crohn’s disease who received anti–tumor necrosis factor therapies (infliximab and adalimumab) or vedolizumab at two university hospitals in France between 2008 and 2015. All patients received baseline and follow-up colonoscopies, with results scored on the CDEIS. In all cases, the second CDEIS score was less than 4 (the CDEIS ranges from 0 to 44). The primary outcome was treatment failure, defined as the need for biologic optimization (increasing the dose or shortening the dosing interval of the biologic), corticosteroids, or immunosuppressants; a Harvey-Bradshaw score greater than 4 associated with a change in treatment; or the need for intestinal resection or hospitalization because of Crohn’s disease.

At baseline, 57 patients had CDEIS scores of 0 (complete mucosal healing) and 27 patients had scores greater than 0 but less than 4 (partial mucosal healing). The two groups were otherwise similar except that patients with complete mucosal healing had a shorter median duration of Crohn’s disease (10.3 vs. 15.1 years in the partial healing group; P = .029) and a lower prevalence of Crohn’s disease phenotype B2 (stricturing) according to the Vienna classification (1.8% vs. 14.8%; P = .035). In the multivariate analysis, CDEIS score was the only factor associated with treatment failure (hazard ratio, 2.61; 95% confidence interval, 1.16-5.88; P = .02).

“Our findings suggest that we should be more ambitious in clinical practice to change patients’ life and disease course by achieving complete endoscopic healing. However, this strategy could be limited by the ability of current drugs to achieve complete mucosal healing,” the researchers wrote. “Obtaining a complete mucosal healing would require today a significant need for optimization or change of biologics.”

No external funding sources were reported. Two coinvestigators disclosed ties to AbbVie, Amgen, Biogaran, Biogen, Ferring, Janssen, MSD, Pfizer, Takeda, and several other pharmaceutical companies. The remaining investigators reported having no relevant conflicts of interest.

SOURCE: Yzet C et al. Clin Gastroenterol Hepatol. 2019 Nov 16. doi: 10.1016/j.cgh.2019.11.025.
 

Patients with Crohn’s disease who experienced complete endoscopic healing with biologic therapy had significantly lower subsequent rates of treatment failure, intestinal resection, and hospitalization, compared with patients who experienced only partial mucosal healing, according to the findings of a two-center retrospective study.

Over a median of 4.8 years of follow-up (interquartile range, 2.1-7.2 years) rates of treatment failure were 25% in patients with complete mucosal healing at baseline (that is, a Crohn’s Disease Endoscopic Index of Severity [CDEIS] score of 0) and 48% in patients with partial healing (CDEIS score greater than 0 but less than 4). The difference was statistically significant (P = .045). No patient with a baseline CDEIS score of 0 required intestinal resection, compared with 11% of patients with scores greater than 0 but less than 4 (P = .031). Rates of hospitalization because of Crohn’s disease were 3.5% versus 18.5%, respectively (P = .013). Clara Yzet, MD, of Amiens (France) University Hospital, Université de Picardie Jules Verne, reported the findings together with her associates in Clinical Gastroenterology and Hepatology.

Mucosal healing is a key therapeutic target in Crohn’s disease that has been linked to desirable outcomes, such as steroid-free remission and a lower rate of intestinal resection. However, prior observational studies have inconsistently defined mucosal healing, and clinical trials of biologics have used any of at least seven different definitions, the researchers wrote. Recently, in patients with ulcerative colitis, a Scandinavian Journal of Gastroenterology and another in the Journal of Crohn’s and Colitis linked a stricter definition of mucosal healing (an endoscopic Mayo score of 0, or histologic healing) with superior long-term clinical outcomes. In patients with Crohn’s disease, however, there has been no established threshold for mucosal healing based on either the CDEIS or the Simplified Endoscopic Score for Crohn’s disease (SES-CD).

Therefore, Dr. Yzet and her associates identified and reviewed the medical records of 84 consecutive adults with clinically remitted Crohn’s disease who received anti–tumor necrosis factor therapies (infliximab and adalimumab) or vedolizumab at two university hospitals in France between 2008 and 2015. All patients received baseline and follow-up colonoscopies, with results scored on the CDEIS. In all cases, the second CDEIS score was less than 4 (the CDEIS ranges from 0 to 44). The primary outcome was treatment failure, defined as the need for biologic optimization (increasing the dose or shortening the dosing interval of the biologic), corticosteroids, or immunosuppressants; a Harvey-Bradshaw score greater than 4 associated with a change in treatment; or the need for intestinal resection or hospitalization because of Crohn’s disease.

At baseline, 57 patients had CDEIS scores of 0 (complete mucosal healing) and 27 patients had scores greater than 0 but less than 4 (partial mucosal healing). The two groups were otherwise similar except that patients with complete mucosal healing had a shorter median duration of Crohn’s disease (10.3 vs. 15.1 years in the partial healing group; P = .029) and a lower prevalence of Crohn’s disease phenotype B2 (stricturing) according to the Vienna classification (1.8% vs. 14.8%; P = .035). In the multivariate analysis, CDEIS score was the only factor associated with treatment failure (hazard ratio, 2.61; 95% confidence interval, 1.16-5.88; P = .02).

“Our findings suggest that we should be more ambitious in clinical practice to change patients’ life and disease course by achieving complete endoscopic healing. However, this strategy could be limited by the ability of current drugs to achieve complete mucosal healing,” the researchers wrote. “Obtaining a complete mucosal healing would require today a significant need for optimization or change of biologics.”

No external funding sources were reported. Two coinvestigators disclosed ties to AbbVie, Amgen, Biogaran, Biogen, Ferring, Janssen, MSD, Pfizer, Takeda, and several other pharmaceutical companies. The remaining investigators reported having no relevant conflicts of interest.

SOURCE: Yzet C et al. Clin Gastroenterol Hepatol. 2019 Nov 16. doi: 10.1016/j.cgh.2019.11.025.
 

Most interventional cardiologists still rely solely upon angiography in making revascularization decisions about intermediate stenoses in the setting of stable coronary artery disease – and in doing so they end up making the wrong call nearly 40% of the time, according to the results of an international survey presented at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“We saw a strong tendency to visually overestimate the percent diameter stenosis,” reported Gabor G. Toth, MD, an interventional cardiologist at the Medical University of Graz (Austria).

The same tendency has been highlighted in numerous randomized trials and observational studies. That’s why both European and U.S. guidelines now strongly recommend invasive functional assessment, such as fractional-flow reserve (FFR) testing, in evaluating the significance of intermediate stenoses in the absence of noninvasive evidence of ischemia. The new survey findings point to an important disconnect between these guideline recommendations and current clinical practice, he noted.

Dr. Toth presented the results of the second web-based, international survey on interventional decision-making strategy sponsored by the European Association of Percutaneous Cardiovascular Interventions. He contrasted the findings with those of the previously reported first international online survey, conducted 6 years earlier, for which he was first author (Circ Cardiovasc Interv. 2014 Dec;7[6]:751-9).

The two surveys were identically designed. In both, participants answered questions that enabled investigators to place them into one of four categories based upon the extent of their experience in interventional cardiology. The participants were also presented with 5 angiograms of focal intermediate stenoses and asked to determine the stenosis significance of each lesion. No information on the functional significance of the stenoses was included; however, the respondents could request additional diagnostic information by “ordering” adjunctive invasive functional assessment tests, including FFR, quantitative coronary angiography, intravascular ultrasound, or optical coherence tomography. Importantly, participating cardiologists were asked to make their decisions based upon best possible clinical practice in a hypothetical scenario where financial constraints had no role.

The second international survey was conducted during the latter half of 2019. The 334 interventional cardiologists who responded performed a total of 978 case evaluations including 2,054 coronary lesion assessments.

About 59% of all decisions were made solely on the basis of angiographic appearance without any information as to the functional significance of a given stenosis: Indeed, 13% of all stenoses were thereby declared to be “certainly” nonsignificant, and 46% were deemed “certainly” significant. In total, that figure was down significantly from the 71% rate in the first survey. In the first survey, 47% of decisions based upon angiographic appearance alone were discordant with FFR results known to the investigators, compared with a 39% discordance rate in the second survey.

Of the physician decisions made in the second survey, 10% involved a request for intravascular imaging, essentially unchanged from the 9% rate in the first survey. However, there was a significant increase over time in requests for invasive functional assessment tests: 25% in the first survey, rising to 31% in the second. This increase was entirely driven by additional requests for data on nonhyperemic pressure ratios; there was no difference in requests for FFR testing between the 2013 and 2019 surveys.

Clinician experience played an interesting role in decision-making: “Experience does not have an impact on the accuracy of angiographically based decisions, but experience does have an impact on understanding the need for adjunctive functional diagnostic testing,” Dr. Toth explained.

Indeed, 21% of decisions made by the least-experienced interventional cardiologists involved a request for adjunctive invasive functional assessment, compared with 24% of decisions by physicians in the third quartile of experience, 32% in the second, and 37% of decisions made by the most experienced clinicians.

Discussant Michael Haude, MD, PhD, said that “these results clearly show that eyeball angioguidance is still the dominant tool used in decision-making, and that this eyeball angioguidance continuously overestimates the stenosis when you compare the results to quantitative coronary angiography.

“These results, surprisingly for me, show a quite low uptake of the invasive functional assessments despite overwhelming scientific data leading to clear guideline-based recommendations. Why is this the case, even after financial constraints are ruled out? Probably because FFR is still a complex invasive procedure. Maybe, in the future, quantitative flow-ratio angiography [which requires no pressure wire] or CT-based FFR will be more popular,” said Dr. Haude, an interventional cardiologist at the Rheinland Clinic in Neuss, Germany.

He reported receiving research grants from Biotronik and serving as a paid consultant to that company as well as Cardiac Dimensions, Orbus Neich, and Philips. Dr. Toth reported having no financial conflicts regarding the international survey.

[email protected]

Most interventional cardiologists still rely solely upon angiography in making revascularization decisions about intermediate stenoses in the setting of stable coronary artery disease – and in doing so they end up making the wrong call nearly 40% of the time, according to the results of an international survey presented at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“We saw a strong tendency to visually overestimate the percent diameter stenosis,” reported Gabor G. Toth, MD, an interventional cardiologist at the Medical University of Graz (Austria).

The same tendency has been highlighted in numerous randomized trials and observational studies. That’s why both European and U.S. guidelines now strongly recommend invasive functional assessment, such as fractional-flow reserve (FFR) testing, in evaluating the significance of intermediate stenoses in the absence of noninvasive evidence of ischemia. The new survey findings point to an important disconnect between these guideline recommendations and current clinical practice, he noted.

Dr. Toth presented the results of the second web-based, international survey on interventional decision-making strategy sponsored by the European Association of Percutaneous Cardiovascular Interventions. He contrasted the findings with those of the previously reported first international online survey, conducted 6 years earlier, for which he was first author (Circ Cardiovasc Interv. 2014 Dec;7[6]:751-9).

The two surveys were identically designed. In both, participants answered questions that enabled investigators to place them into one of four categories based upon the extent of their experience in interventional cardiology. The participants were also presented with 5 angiograms of focal intermediate stenoses and asked to determine the stenosis significance of each lesion. No information on the functional significance of the stenoses was included; however, the respondents could request additional diagnostic information by “ordering” adjunctive invasive functional assessment tests, including FFR, quantitative coronary angiography, intravascular ultrasound, or optical coherence tomography. Importantly, participating cardiologists were asked to make their decisions based upon best possible clinical practice in a hypothetical scenario where financial constraints had no role.

The second international survey was conducted during the latter half of 2019. The 334 interventional cardiologists who responded performed a total of 978 case evaluations including 2,054 coronary lesion assessments.

About 59% of all decisions were made solely on the basis of angiographic appearance without any information as to the functional significance of a given stenosis: Indeed, 13% of all stenoses were thereby declared to be “certainly” nonsignificant, and 46% were deemed “certainly” significant. In total, that figure was down significantly from the 71% rate in the first survey. In the first survey, 47% of decisions based upon angiographic appearance alone were discordant with FFR results known to the investigators, compared with a 39% discordance rate in the second survey.

Of the physician decisions made in the second survey, 10% involved a request for intravascular imaging, essentially unchanged from the 9% rate in the first survey. However, there was a significant increase over time in requests for invasive functional assessment tests: 25% in the first survey, rising to 31% in the second. This increase was entirely driven by additional requests for data on nonhyperemic pressure ratios; there was no difference in requests for FFR testing between the 2013 and 2019 surveys.

Clinician experience played an interesting role in decision-making: “Experience does not have an impact on the accuracy of angiographically based decisions, but experience does have an impact on understanding the need for adjunctive functional diagnostic testing,” Dr. Toth explained.

Indeed, 21% of decisions made by the least-experienced interventional cardiologists involved a request for adjunctive invasive functional assessment, compared with 24% of decisions by physicians in the third quartile of experience, 32% in the second, and 37% of decisions made by the most experienced clinicians.

Discussant Michael Haude, MD, PhD, said that “these results clearly show that eyeball angioguidance is still the dominant tool used in decision-making, and that this eyeball angioguidance continuously overestimates the stenosis when you compare the results to quantitative coronary angiography.

“These results, surprisingly for me, show a quite low uptake of the invasive functional assessments despite overwhelming scientific data leading to clear guideline-based recommendations. Why is this the case, even after financial constraints are ruled out? Probably because FFR is still a complex invasive procedure. Maybe, in the future, quantitative flow-ratio angiography [which requires no pressure wire] or CT-based FFR will be more popular,” said Dr. Haude, an interventional cardiologist at the Rheinland Clinic in Neuss, Germany.

He reported receiving research grants from Biotronik and serving as a paid consultant to that company as well as Cardiac Dimensions, Orbus Neich, and Philips. Dr. Toth reported having no financial conflicts regarding the international survey.

[email protected]

Most interventional cardiologists still rely solely upon angiography in making revascularization decisions about intermediate stenoses in the setting of stable coronary artery disease – and in doing so they end up making the wrong call nearly 40% of the time, according to the results of an international survey presented at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“We saw a strong tendency to visually overestimate the percent diameter stenosis,” reported Gabor G. Toth, MD, an interventional cardiologist at the Medical University of Graz (Austria).

The same tendency has been highlighted in numerous randomized trials and observational studies. That’s why both European and U.S. guidelines now strongly recommend invasive functional assessment, such as fractional-flow reserve (FFR) testing, in evaluating the significance of intermediate stenoses in the absence of noninvasive evidence of ischemia. The new survey findings point to an important disconnect between these guideline recommendations and current clinical practice, he noted.

Dr. Toth presented the results of the second web-based, international survey on interventional decision-making strategy sponsored by the European Association of Percutaneous Cardiovascular Interventions. He contrasted the findings with those of the previously reported first international online survey, conducted 6 years earlier, for which he was first author (Circ Cardiovasc Interv. 2014 Dec;7[6]:751-9).

The two surveys were identically designed. In both, participants answered questions that enabled investigators to place them into one of four categories based upon the extent of their experience in interventional cardiology. The participants were also presented with 5 angiograms of focal intermediate stenoses and asked to determine the stenosis significance of each lesion. No information on the functional significance of the stenoses was included; however, the respondents could request additional diagnostic information by “ordering” adjunctive invasive functional assessment tests, including FFR, quantitative coronary angiography, intravascular ultrasound, or optical coherence tomography. Importantly, participating cardiologists were asked to make their decisions based upon best possible clinical practice in a hypothetical scenario where financial constraints had no role.

The second international survey was conducted during the latter half of 2019. The 334 interventional cardiologists who responded performed a total of 978 case evaluations including 2,054 coronary lesion assessments.

About 59% of all decisions were made solely on the basis of angiographic appearance without any information as to the functional significance of a given stenosis: Indeed, 13% of all stenoses were thereby declared to be “certainly” nonsignificant, and 46% were deemed “certainly” significant. In total, that figure was down significantly from the 71% rate in the first survey. In the first survey, 47% of decisions based upon angiographic appearance alone were discordant with FFR results known to the investigators, compared with a 39% discordance rate in the second survey.

Of the physician decisions made in the second survey, 10% involved a request for intravascular imaging, essentially unchanged from the 9% rate in the first survey. However, there was a significant increase over time in requests for invasive functional assessment tests: 25% in the first survey, rising to 31% in the second. This increase was entirely driven by additional requests for data on nonhyperemic pressure ratios; there was no difference in requests for FFR testing between the 2013 and 2019 surveys.

Clinician experience played an interesting role in decision-making: “Experience does not have an impact on the accuracy of angiographically based decisions, but experience does have an impact on understanding the need for adjunctive functional diagnostic testing,” Dr. Toth explained.

Indeed, 21% of decisions made by the least-experienced interventional cardiologists involved a request for adjunctive invasive functional assessment, compared with 24% of decisions by physicians in the third quartile of experience, 32% in the second, and 37% of decisions made by the most experienced clinicians.

Discussant Michael Haude, MD, PhD, said that “these results clearly show that eyeball angioguidance is still the dominant tool used in decision-making, and that this eyeball angioguidance continuously overestimates the stenosis when you compare the results to quantitative coronary angiography.

“These results, surprisingly for me, show a quite low uptake of the invasive functional assessments despite overwhelming scientific data leading to clear guideline-based recommendations. Why is this the case, even after financial constraints are ruled out? Probably because FFR is still a complex invasive procedure. Maybe, in the future, quantitative flow-ratio angiography [which requires no pressure wire] or CT-based FFR will be more popular,” said Dr. Haude, an interventional cardiologist at the Rheinland Clinic in Neuss, Germany.

He reported receiving research grants from Biotronik and serving as a paid consultant to that company as well as Cardiac Dimensions, Orbus Neich, and Philips. Dr. Toth reported having no financial conflicts regarding the international survey.

[email protected]

For some palliative care professionals, the COVID-19 pandemic, particularly in viral hot spots like New York City, represents a “moment” that could lead to greater awareness of what this service offers to seriously ill patients in a crisis.

They say it has provided an opportunity to show what palliative care teams can contribute to the difficult circumstances of patients with severe symptoms, isolated and alone in quarantined hospitals, with poor survival rates, perhaps sedated for extended stays on scarce ventilators – and for their family members, who are able to visit them only virtually via telephone or tablet.

But it has also highlighted gaps – including insufficient staffing for some palliative care teams. Hospitalists and other clinicians in the hospital need to learn the basics of primary palliative care, such as how to communicate bad news, initiate goals of care conversations, and address common symptoms of serious illness, such as pain. That way, they could shoulder more of the demand for this kind of care when palliative care specialists are in short supply.

Hospitalists, some of whom also have pursued a specialization in palliative care, have played key roles in clarifying and redefining the new role for palliative care, whom it is meant for, and who should provide it. Central to this new role is the greater use of telemedicine – for talking to hospitalized patients without increasing viral exposure, for linking up with family members who can’t visit their loved ones in the hospital, and for helping frontline hospital staff who need a palliative care consultation – or just a chance to debrief on what they are seeing.

A pandemic wake-up call

Elizabeth Gundersen, MD, FHM, FAAHPM, director of the hospice and palliative medicine fellowship program at the Charles E. Schmidt College of Medicine at Florida Atlantic University (FAU) in Boca Raton, practiced hospital medicine for 10 years before pursuing a fellowship in hospice and palliative medicine and working as an academic palliative medicine physician. She calls the pandemic a wake-up call for gaps in care and all the things that weren’t working well in the health care system.

“Now we are seeing more clearly what’s lacking – or broken – and what we will carry forward from this experience into the post-COVID world,” she said. Some hospitalists do palliative care very well, and others don’t feel as comfortable in having these difficult conversations with patients. But in the uncertain course of the virus they get thrust into it.

Although FAU’s associated hospitals were not as inundated with COVID-19 patients in the early weeks of the pandemic as were other regions, the volume of other patients plummeted, Dr. Gundersen said, adding that “there’s still been incredible intensity and worry about the virus. For me, the basic role of palliative care hasn’t changed, and the phrase I have always used when introducing myself – ‘we’re an extra layer of support for the patient and family’ – still holds true,” she said.

“I try to make it clear to people that palliative care is not synonymous with end-of-life care. We don’t want people to think that a palliative care referral implies imminent death. The goal is not to get more people to have a do not attempt resuscitation (DNAR) order, but to determine the patient and family’s treatment goals and whether a DNAR order fits those goals.”

The tough conversations

Dr. Gundersen is cochair of SHM’s Palliative Care Special Interest Group, along with Rab Razzak, MD, clinical director of palliative medicine at University Hospitals Cleveland Medical Center, one of the hospitals affiliated with Case Western University in Cleveland. (Connect with them on Twitter: @Top_Gundersen and @rabrazzak.)

Kim Fatica, University Hospitals Cleveland Medical Center

Dr. Razzak also transitioned from hospital medicine to palliative medicine 10 years ago. “As a hospitalist, I enjoyed the tough conversations and bringing the human element into my health care interactions,” he explained. “To me, palliative care is a philosophy of care that puts the person we call the patient at the center of the interaction, while we try to figure out how to best care for them as a person.”

When the pandemic hit, University Hospitals made 20 ICU beds available for COVID-19 patients, Dr. Razzak said. This unit has since been full but not overflowing, while overall hospital census went down. The palliative care team at the hospital includes four inpatient doctors, nurse practitioners, and a chaplain, as well as an outpatient team primarily focused on oncology.

“In some settings, palliative care has been at the forefront of difficult conversations, when things aren’t going well for the patient and there’s much uncertainty,” Dr. Razzak said. The interface between hospital medicine and palliative care can be complementary, he added. “We talk about primary palliative care, which we want every discipline to be able to do – lead meaningful conversations, help manage symptoms.”

The take-home message for hospitalists, he said, is to get training in how to have these discussions, using such resources as VitalTalk (https://www.vitaltalk.org/), a nonprofit organization that disseminates education in communication skills for difficult conversations, and the Center to Advance Palliative Care (www.capc.org) at Icahn School of Medicine at Mount Sinai in New York City. “Once you’ve mastered the conversation, it will get easier. But ask for help when you need it, and learn how to know when you need it.”

Dr. Gundersen added that hospital medicine groups and palliative care teams could reach out to each other and talk about what they did in the crisis and how they can work together in the future. She recommends frequent ongoing support and collaboration that could range from formal conferences or training sessions to informal team interactions, perhaps with sandwiches in the doctor’s lounge – provided that there’s room for social distancing. She has recently started giving talks in the community and grand rounds presentations in hospitals about palliative care.
 

Other approaches and applications

In New York City, the initial epicenter for the pandemic in the United States, the adult palliative care service of Columbia University Medical Center (CUMC) experienced a sevenfold increase in consultation requests at the apex of the crisis, said its director, Craig Blinderman, MD. That demand was impossible to meet with existing staff. So Dr. Blinderman and colleagues established a virtual consultation model, recruiting and deploying volunteer out-of-state palliative care specialists to staff it.

An eight-bed palliative care unit was opened at CUMC for COVID-19 patients whose surrogates had opted not to initiate or continue intubation or life-sustaining treatments. This helped to relieve some of the pressures on the ICUs while making it possible for in-person visits to the hospice unit by families – in full PPE. Palliative care staff were embedded in various units in the hospital.

A palliative care response team composed of a hospice and palliative medicine fellow and four psychiatry residents or fellows, based in the emergency department and with supervision from the palliative care team, provided time-critical goals of care conversations with families using telemedicine – and a forum for listening to their suffering. Dr. Blinderman and colleagues also have found time to write up their experience for medical journals.^1,2

There’s no reason to think that hospitalists, with a little basic training, couldn’t be having these same goals of care conversations, Dr. Blinderman said. “But the fact that hospitalists, at the pandemic’s peak, along with ICU doctors, were seeing an unprecedented magnitude of dying on a daily basis generated a lot of moral distress for them.”

Palliative care professionals, because they engage with these issues in a different way, may be somewhat better equipped to deal with the sheer emotional demands when so many are dying, as at the peak of the surge in New York. “We don’t see dying as a failure on our part but an opportunity to relieve suffering,” Dr. Blinderman said. And the palliative care field also emphasizes the importance of self-care for its practitioners.

“How do we meet the incredible palliative care needs in the epicenter of a pandemic? That question also applies to other kinds of crises we could imagine, for example, climate-related disasters,” Dr. Blinderman said. “What lessons have we learned about the value of palliative care and how to start incorporating it more integrally into the delivery of hospital care? Here we showed that we could work collaboratively with our colleagues at other major medical centers, bringing together their expertise to help us when we didn’t have the bandwidth to meet the demand,” he said.
 

Scripts can help

“Also, it won’t make sense to just go back to normal (after the crisis fades),” Dr. Blinderman said. “We need to take a close look at how our society is functioning in the wake of the pandemic and the ways the health care system has failed us. We have learned that we’re all interconnected and we need to work together to serve our communities – locally and nationally – applying basic distributive justice.”

Could there be, for example, a national infrastructure for mobilizing and deploying palliative care resources to areas of greatest need, similar to what was done in New York?

At Northwestern Medicine in Chicago, a number of palliative care clinicians at the system’s hospitals worked together to develop scripts designed to help other clinicians start goals of care conversations with patients and families, for use in the hospital as well as in outpatient primary care and other settings, with results integrated into the system’s electronic health record.

Front-line clinicians may not have the time to ask for formal consults from palliative care because of high volume and rapidly changing patient status, explained Eytan Szmuilowicz, MD, director of the section of palliative medicine at Northwestern Memorial Hospital. Or they may not have access to specialty-level palliative care in their settings.

The scripts are aimed at primary care, emergency physicians, and hospitalists needing to consider critical care placement or attempted resuscitation and to ICU clinicians helping families make decisions about life-sustaining treatments. They also can help facilitate advance care planning discussions. An example is “CALMER,” a six-step mnemonic guide to promote goals of care discussions with hospitalized patients. For more information on these scripts, contact Dr. Szmuilowicz: [email protected].

Eerily quiet

The COVID-19 crisis has been quite a whirlwind for hospital medicine, said Jeanie Youngwerth, MD, a hospitalist and program director of the palliative care service at the University of Colorado in Denver, which was a significant viral hotspot early on.

“When it first started, things seemed to change almost overnight – starting on Friday, March 13. People had to take action right away to develop work flows and the technology to allow us to see as many patients as possible,” she said. By the time Monday came, it was a whole new ballgame.

Dr. Youngwerth and two colleagues worked quickly to develop inpatient telemedicine capacity where none existed. “We knew we would not be going into patients’ rooms, but most of our team showed up in the hospital to work with the primary care teams. Our job was to see what we could do that actually made a difference,” she said.

“The hospital became a very strange place. You’d walk down the hallway and it was eerily quiet. Everybody you came across was being so nice to each other.” Televisits became a powerful way to bring the human connection back to medical care.

“What we learned from families was that they were thirsting to have some kind of connection with their loved one, and to be able to talk about their loved one and who they were as a person,” she said. “We’d contact the family through video visits and then, when the family meeting ended, the nurse would bring an iPad into the patient’s room so the family could see their loved one on a ventilator. They would immediately start communicating with their loved one, praying aloud, singing, playing music. It would make a huge difference for the family – and for the staff.”
 

References

1. Nakagawa S et al. Pandemic palliative care consultations spanning state and institutional borders. J Am Geriatr Soc. 2020 May 22. doi: 10.1111/jgs.16643.

2. Lee J Abrukin L, Flores S. Early intervention of palliative care in the emergency department during the COVID-19 pandemic. JAMA Intern Med. 2020 Jun 5. doi: 10.1001/jamainternmed.2020.2713.

For some palliative care professionals, the COVID-19 pandemic, particularly in viral hot spots like New York City, represents a “moment” that could lead to greater awareness of what this service offers to seriously ill patients in a crisis.

They say it has provided an opportunity to show what palliative care teams can contribute to the difficult circumstances of patients with severe symptoms, isolated and alone in quarantined hospitals, with poor survival rates, perhaps sedated for extended stays on scarce ventilators – and for their family members, who are able to visit them only virtually via telephone or tablet.

But it has also highlighted gaps – including insufficient staffing for some palliative care teams. Hospitalists and other clinicians in the hospital need to learn the basics of primary palliative care, such as how to communicate bad news, initiate goals of care conversations, and address common symptoms of serious illness, such as pain. That way, they could shoulder more of the demand for this kind of care when palliative care specialists are in short supply.

Hospitalists, some of whom also have pursued a specialization in palliative care, have played key roles in clarifying and redefining the new role for palliative care, whom it is meant for, and who should provide it. Central to this new role is the greater use of telemedicine – for talking to hospitalized patients without increasing viral exposure, for linking up with family members who can’t visit their loved ones in the hospital, and for helping frontline hospital staff who need a palliative care consultation – or just a chance to debrief on what they are seeing.

A pandemic wake-up call

Elizabeth Gundersen, MD, FHM, FAAHPM, director of the hospice and palliative medicine fellowship program at the Charles E. Schmidt College of Medicine at Florida Atlantic University (FAU) in Boca Raton, practiced hospital medicine for 10 years before pursuing a fellowship in hospice and palliative medicine and working as an academic palliative medicine physician. She calls the pandemic a wake-up call for gaps in care and all the things that weren’t working well in the health care system.

“Now we are seeing more clearly what’s lacking – or broken – and what we will carry forward from this experience into the post-COVID world,” she said. Some hospitalists do palliative care very well, and others don’t feel as comfortable in having these difficult conversations with patients. But in the uncertain course of the virus they get thrust into it.

Although FAU’s associated hospitals were not as inundated with COVID-19 patients in the early weeks of the pandemic as were other regions, the volume of other patients plummeted, Dr. Gundersen said, adding that “there’s still been incredible intensity and worry about the virus. For me, the basic role of palliative care hasn’t changed, and the phrase I have always used when introducing myself – ‘we’re an extra layer of support for the patient and family’ – still holds true,” she said.

“I try to make it clear to people that palliative care is not synonymous with end-of-life care. We don’t want people to think that a palliative care referral implies imminent death. The goal is not to get more people to have a do not attempt resuscitation (DNAR) order, but to determine the patient and family’s treatment goals and whether a DNAR order fits those goals.”

The tough conversations

Dr. Gundersen is cochair of SHM’s Palliative Care Special Interest Group, along with Rab Razzak, MD, clinical director of palliative medicine at University Hospitals Cleveland Medical Center, one of the hospitals affiliated with Case Western University in Cleveland. (Connect with them on Twitter: @Top_Gundersen and @rabrazzak.)

Kim Fatica, University Hospitals Cleveland Medical Center

Dr. Razzak also transitioned from hospital medicine to palliative medicine 10 years ago. “As a hospitalist, I enjoyed the tough conversations and bringing the human element into my health care interactions,” he explained. “To me, palliative care is a philosophy of care that puts the person we call the patient at the center of the interaction, while we try to figure out how to best care for them as a person.”

When the pandemic hit, University Hospitals made 20 ICU beds available for COVID-19 patients, Dr. Razzak said. This unit has since been full but not overflowing, while overall hospital census went down. The palliative care team at the hospital includes four inpatient doctors, nurse practitioners, and a chaplain, as well as an outpatient team primarily focused on oncology.

“In some settings, palliative care has been at the forefront of difficult conversations, when things aren’t going well for the patient and there’s much uncertainty,” Dr. Razzak said. The interface between hospital medicine and palliative care can be complementary, he added. “We talk about primary palliative care, which we want every discipline to be able to do – lead meaningful conversations, help manage symptoms.”

The take-home message for hospitalists, he said, is to get training in how to have these discussions, using such resources as VitalTalk (https://www.vitaltalk.org/), a nonprofit organization that disseminates education in communication skills for difficult conversations, and the Center to Advance Palliative Care (www.capc.org) at Icahn School of Medicine at Mount Sinai in New York City. “Once you’ve mastered the conversation, it will get easier. But ask for help when you need it, and learn how to know when you need it.”

Dr. Gundersen added that hospital medicine groups and palliative care teams could reach out to each other and talk about what they did in the crisis and how they can work together in the future. She recommends frequent ongoing support and collaboration that could range from formal conferences or training sessions to informal team interactions, perhaps with sandwiches in the doctor’s lounge – provided that there’s room for social distancing. She has recently started giving talks in the community and grand rounds presentations in hospitals about palliative care.
 

Other approaches and applications

In New York City, the initial epicenter for the pandemic in the United States, the adult palliative care service of Columbia University Medical Center (CUMC) experienced a sevenfold increase in consultation requests at the apex of the crisis, said its director, Craig Blinderman, MD. That demand was impossible to meet with existing staff. So Dr. Blinderman and colleagues established a virtual consultation model, recruiting and deploying volunteer out-of-state palliative care specialists to staff it.

An eight-bed palliative care unit was opened at CUMC for COVID-19 patients whose surrogates had opted not to initiate or continue intubation or life-sustaining treatments. This helped to relieve some of the pressures on the ICUs while making it possible for in-person visits to the hospice unit by families – in full PPE. Palliative care staff were embedded in various units in the hospital.

A palliative care response team composed of a hospice and palliative medicine fellow and four psychiatry residents or fellows, based in the emergency department and with supervision from the palliative care team, provided time-critical goals of care conversations with families using telemedicine – and a forum for listening to their suffering. Dr. Blinderman and colleagues also have found time to write up their experience for medical journals.^1,2

There’s no reason to think that hospitalists, with a little basic training, couldn’t be having these same goals of care conversations, Dr. Blinderman said. “But the fact that hospitalists, at the pandemic’s peak, along with ICU doctors, were seeing an unprecedented magnitude of dying on a daily basis generated a lot of moral distress for them.”

Palliative care professionals, because they engage with these issues in a different way, may be somewhat better equipped to deal with the sheer emotional demands when so many are dying, as at the peak of the surge in New York. “We don’t see dying as a failure on our part but an opportunity to relieve suffering,” Dr. Blinderman said. And the palliative care field also emphasizes the importance of self-care for its practitioners.

“How do we meet the incredible palliative care needs in the epicenter of a pandemic? That question also applies to other kinds of crises we could imagine, for example, climate-related disasters,” Dr. Blinderman said. “What lessons have we learned about the value of palliative care and how to start incorporating it more integrally into the delivery of hospital care? Here we showed that we could work collaboratively with our colleagues at other major medical centers, bringing together their expertise to help us when we didn’t have the bandwidth to meet the demand,” he said.
 

Scripts can help

“Also, it won’t make sense to just go back to normal (after the crisis fades),” Dr. Blinderman said. “We need to take a close look at how our society is functioning in the wake of the pandemic and the ways the health care system has failed us. We have learned that we’re all interconnected and we need to work together to serve our communities – locally and nationally – applying basic distributive justice.”

Could there be, for example, a national infrastructure for mobilizing and deploying palliative care resources to areas of greatest need, similar to what was done in New York?

At Northwestern Medicine in Chicago, a number of palliative care clinicians at the system’s hospitals worked together to develop scripts designed to help other clinicians start goals of care conversations with patients and families, for use in the hospital as well as in outpatient primary care and other settings, with results integrated into the system’s electronic health record.

Front-line clinicians may not have the time to ask for formal consults from palliative care because of high volume and rapidly changing patient status, explained Eytan Szmuilowicz, MD, director of the section of palliative medicine at Northwestern Memorial Hospital. Or they may not have access to specialty-level palliative care in their settings.

The scripts are aimed at primary care, emergency physicians, and hospitalists needing to consider critical care placement or attempted resuscitation and to ICU clinicians helping families make decisions about life-sustaining treatments. They also can help facilitate advance care planning discussions. An example is “CALMER,” a six-step mnemonic guide to promote goals of care discussions with hospitalized patients. For more information on these scripts, contact Dr. Szmuilowicz: [email protected].

Eerily quiet

The COVID-19 crisis has been quite a whirlwind for hospital medicine, said Jeanie Youngwerth, MD, a hospitalist and program director of the palliative care service at the University of Colorado in Denver, which was a significant viral hotspot early on.

“When it first started, things seemed to change almost overnight – starting on Friday, March 13. People had to take action right away to develop work flows and the technology to allow us to see as many patients as possible,” she said. By the time Monday came, it was a whole new ballgame.

Dr. Youngwerth and two colleagues worked quickly to develop inpatient telemedicine capacity where none existed. “We knew we would not be going into patients’ rooms, but most of our team showed up in the hospital to work with the primary care teams. Our job was to see what we could do that actually made a difference,” she said.

“The hospital became a very strange place. You’d walk down the hallway and it was eerily quiet. Everybody you came across was being so nice to each other.” Televisits became a powerful way to bring the human connection back to medical care.

“What we learned from families was that they were thirsting to have some kind of connection with their loved one, and to be able to talk about their loved one and who they were as a person,” she said. “We’d contact the family through video visits and then, when the family meeting ended, the nurse would bring an iPad into the patient’s room so the family could see their loved one on a ventilator. They would immediately start communicating with their loved one, praying aloud, singing, playing music. It would make a huge difference for the family – and for the staff.”
 

References

1. Nakagawa S et al. Pandemic palliative care consultations spanning state and institutional borders. J Am Geriatr Soc. 2020 May 22. doi: 10.1111/jgs.16643.

2. Lee J Abrukin L, Flores S. Early intervention of palliative care in the emergency department during the COVID-19 pandemic. JAMA Intern Med. 2020 Jun 5. doi: 10.1001/jamainternmed.2020.2713.

For some palliative care professionals, the COVID-19 pandemic, particularly in viral hot spots like New York City, represents a “moment” that could lead to greater awareness of what this service offers to seriously ill patients in a crisis.

They say it has provided an opportunity to show what palliative care teams can contribute to the difficult circumstances of patients with severe symptoms, isolated and alone in quarantined hospitals, with poor survival rates, perhaps sedated for extended stays on scarce ventilators – and for their family members, who are able to visit them only virtually via telephone or tablet.

But it has also highlighted gaps – including insufficient staffing for some palliative care teams. Hospitalists and other clinicians in the hospital need to learn the basics of primary palliative care, such as how to communicate bad news, initiate goals of care conversations, and address common symptoms of serious illness, such as pain. That way, they could shoulder more of the demand for this kind of care when palliative care specialists are in short supply.

Hospitalists, some of whom also have pursued a specialization in palliative care, have played key roles in clarifying and redefining the new role for palliative care, whom it is meant for, and who should provide it. Central to this new role is the greater use of telemedicine – for talking to hospitalized patients without increasing viral exposure, for linking up with family members who can’t visit their loved ones in the hospital, and for helping frontline hospital staff who need a palliative care consultation – or just a chance to debrief on what they are seeing.

A pandemic wake-up call

Elizabeth Gundersen, MD, FHM, FAAHPM, director of the hospice and palliative medicine fellowship program at the Charles E. Schmidt College of Medicine at Florida Atlantic University (FAU) in Boca Raton, practiced hospital medicine for 10 years before pursuing a fellowship in hospice and palliative medicine and working as an academic palliative medicine physician. She calls the pandemic a wake-up call for gaps in care and all the things that weren’t working well in the health care system.

“Now we are seeing more clearly what’s lacking – or broken – and what we will carry forward from this experience into the post-COVID world,” she said. Some hospitalists do palliative care very well, and others don’t feel as comfortable in having these difficult conversations with patients. But in the uncertain course of the virus they get thrust into it.

Although FAU’s associated hospitals were not as inundated with COVID-19 patients in the early weeks of the pandemic as were other regions, the volume of other patients plummeted, Dr. Gundersen said, adding that “there’s still been incredible intensity and worry about the virus. For me, the basic role of palliative care hasn’t changed, and the phrase I have always used when introducing myself – ‘we’re an extra layer of support for the patient and family’ – still holds true,” she said.

“I try to make it clear to people that palliative care is not synonymous with end-of-life care. We don’t want people to think that a palliative care referral implies imminent death. The goal is not to get more people to have a do not attempt resuscitation (DNAR) order, but to determine the patient and family’s treatment goals and whether a DNAR order fits those goals.”

The tough conversations

Dr. Gundersen is cochair of SHM’s Palliative Care Special Interest Group, along with Rab Razzak, MD, clinical director of palliative medicine at University Hospitals Cleveland Medical Center, one of the hospitals affiliated with Case Western University in Cleveland. (Connect with them on Twitter: @Top_Gundersen and @rabrazzak.)

Kim Fatica, University Hospitals Cleveland Medical Center

Dr. Razzak also transitioned from hospital medicine to palliative medicine 10 years ago. “As a hospitalist, I enjoyed the tough conversations and bringing the human element into my health care interactions,” he explained. “To me, palliative care is a philosophy of care that puts the person we call the patient at the center of the interaction, while we try to figure out how to best care for them as a person.”

When the pandemic hit, University Hospitals made 20 ICU beds available for COVID-19 patients, Dr. Razzak said. This unit has since been full but not overflowing, while overall hospital census went down. The palliative care team at the hospital includes four inpatient doctors, nurse practitioners, and a chaplain, as well as an outpatient team primarily focused on oncology.

“In some settings, palliative care has been at the forefront of difficult conversations, when things aren’t going well for the patient and there’s much uncertainty,” Dr. Razzak said. The interface between hospital medicine and palliative care can be complementary, he added. “We talk about primary palliative care, which we want every discipline to be able to do – lead meaningful conversations, help manage symptoms.”

The take-home message for hospitalists, he said, is to get training in how to have these discussions, using such resources as VitalTalk (https://www.vitaltalk.org/), a nonprofit organization that disseminates education in communication skills for difficult conversations, and the Center to Advance Palliative Care (www.capc.org) at Icahn School of Medicine at Mount Sinai in New York City. “Once you’ve mastered the conversation, it will get easier. But ask for help when you need it, and learn how to know when you need it.”

Dr. Gundersen added that hospital medicine groups and palliative care teams could reach out to each other and talk about what they did in the crisis and how they can work together in the future. She recommends frequent ongoing support and collaboration that could range from formal conferences or training sessions to informal team interactions, perhaps with sandwiches in the doctor’s lounge – provided that there’s room for social distancing. She has recently started giving talks in the community and grand rounds presentations in hospitals about palliative care.
 

Other approaches and applications

In New York City, the initial epicenter for the pandemic in the United States, the adult palliative care service of Columbia University Medical Center (CUMC) experienced a sevenfold increase in consultation requests at the apex of the crisis, said its director, Craig Blinderman, MD. That demand was impossible to meet with existing staff. So Dr. Blinderman and colleagues established a virtual consultation model, recruiting and deploying volunteer out-of-state palliative care specialists to staff it.

An eight-bed palliative care unit was opened at CUMC for COVID-19 patients whose surrogates had opted not to initiate or continue intubation or life-sustaining treatments. This helped to relieve some of the pressures on the ICUs while making it possible for in-person visits to the hospice unit by families – in full PPE. Palliative care staff were embedded in various units in the hospital.

A palliative care response team composed of a hospice and palliative medicine fellow and four psychiatry residents or fellows, based in the emergency department and with supervision from the palliative care team, provided time-critical goals of care conversations with families using telemedicine – and a forum for listening to their suffering. Dr. Blinderman and colleagues also have found time to write up their experience for medical journals.^1,2

There’s no reason to think that hospitalists, with a little basic training, couldn’t be having these same goals of care conversations, Dr. Blinderman said. “But the fact that hospitalists, at the pandemic’s peak, along with ICU doctors, were seeing an unprecedented magnitude of dying on a daily basis generated a lot of moral distress for them.”

Palliative care professionals, because they engage with these issues in a different way, may be somewhat better equipped to deal with the sheer emotional demands when so many are dying, as at the peak of the surge in New York. “We don’t see dying as a failure on our part but an opportunity to relieve suffering,” Dr. Blinderman said. And the palliative care field also emphasizes the importance of self-care for its practitioners.

“How do we meet the incredible palliative care needs in the epicenter of a pandemic? That question also applies to other kinds of crises we could imagine, for example, climate-related disasters,” Dr. Blinderman said. “What lessons have we learned about the value of palliative care and how to start incorporating it more integrally into the delivery of hospital care? Here we showed that we could work collaboratively with our colleagues at other major medical centers, bringing together their expertise to help us when we didn’t have the bandwidth to meet the demand,” he said.
 

Scripts can help

“Also, it won’t make sense to just go back to normal (after the crisis fades),” Dr. Blinderman said. “We need to take a close look at how our society is functioning in the wake of the pandemic and the ways the health care system has failed us. We have learned that we’re all interconnected and we need to work together to serve our communities – locally and nationally – applying basic distributive justice.”

Could there be, for example, a national infrastructure for mobilizing and deploying palliative care resources to areas of greatest need, similar to what was done in New York?

At Northwestern Medicine in Chicago, a number of palliative care clinicians at the system’s hospitals worked together to develop scripts designed to help other clinicians start goals of care conversations with patients and families, for use in the hospital as well as in outpatient primary care and other settings, with results integrated into the system’s electronic health record.

Front-line clinicians may not have the time to ask for formal consults from palliative care because of high volume and rapidly changing patient status, explained Eytan Szmuilowicz, MD, director of the section of palliative medicine at Northwestern Memorial Hospital. Or they may not have access to specialty-level palliative care in their settings.

The scripts are aimed at primary care, emergency physicians, and hospitalists needing to consider critical care placement or attempted resuscitation and to ICU clinicians helping families make decisions about life-sustaining treatments. They also can help facilitate advance care planning discussions. An example is “CALMER,” a six-step mnemonic guide to promote goals of care discussions with hospitalized patients. For more information on these scripts, contact Dr. Szmuilowicz: [email protected].

Eerily quiet

The COVID-19 crisis has been quite a whirlwind for hospital medicine, said Jeanie Youngwerth, MD, a hospitalist and program director of the palliative care service at the University of Colorado in Denver, which was a significant viral hotspot early on.

“When it first started, things seemed to change almost overnight – starting on Friday, March 13. People had to take action right away to develop work flows and the technology to allow us to see as many patients as possible,” she said. By the time Monday came, it was a whole new ballgame.

Dr. Youngwerth and two colleagues worked quickly to develop inpatient telemedicine capacity where none existed. “We knew we would not be going into patients’ rooms, but most of our team showed up in the hospital to work with the primary care teams. Our job was to see what we could do that actually made a difference,” she said.

“The hospital became a very strange place. You’d walk down the hallway and it was eerily quiet. Everybody you came across was being so nice to each other.” Televisits became a powerful way to bring the human connection back to medical care.

“What we learned from families was that they were thirsting to have some kind of connection with their loved one, and to be able to talk about their loved one and who they were as a person,” she said. “We’d contact the family through video visits and then, when the family meeting ended, the nurse would bring an iPad into the patient’s room so the family could see their loved one on a ventilator. They would immediately start communicating with their loved one, praying aloud, singing, playing music. It would make a huge difference for the family – and for the staff.”
 

References

1. Nakagawa S et al. Pandemic palliative care consultations spanning state and institutional borders. J Am Geriatr Soc. 2020 May 22. doi: 10.1111/jgs.16643.

2. Lee J Abrukin L, Flores S. Early intervention of palliative care in the emergency department during the COVID-19 pandemic. JAMA Intern Med. 2020 Jun 5. doi: 10.1001/jamainternmed.2020.2713.

Because heart failure patients with recovered ejection fraction are a complex and diverse group, little consensus has emerged on how to define, diagnose, and manage this growing population.

To provide some clarity for identifying and treating these patients, a Journal of the American College of Cardiology scientific expert panel has issued a consensus document. Published Aug. 3 in the Journal of the American College of Cardiology, it provides a working definition of heart failure with recovered ejection fraction (HFrecEF) and recommends approaches for treatment and follow-up.
 

Defining a new class of HF

“Part of the impetus of this was to bring attention to what we think is a new class of heart failure, and it requires different treatment modalities and different ways of thinking about it,” expert panel member Douglas L. Mann, MD, cardiologist-in-chief at Barnes Jewish Hospital in St. Louis, said in an interview. “It’s a newly discovered HF biology about which we know very little and it’s very confusing to just go on the ejection fraction alone.”

The panel, led by Jane E. Wilcox, MD, of Northwestern University, Chicago, recommends three components for a working definition of HFrecEF: 1) documentation of a decreased left ventricle ejection fraction (LVEF) of less than 40% at baseline; 2) a 10% or greater absolute improvement in LVEF; and 3) a second measurement of LVEF >40%.

“We try to give it a nomenclature that clearly indicates what it is,” Dr. Mann said. “There has been a lot of confusing terminology.” Among the terms the panel calls out in the lexicon of modestly recovered EF, in addition to HFrecEF, are HF improved EF, HF with preserved EF (HFpEF), borderline HFpEF and HF with mid-range EF (HFmrEF).

The panel also recommends that guideline-based medical and device therapies for HFrecEF should continue indefinitely until there’s a better understanding of the biology and clinical epidemiology of HFrecEF, and that these patients should have close clinical follow-up because of the high risk of HF relapse.

Determining EF’s ‘trajectory’

The findings presented in the statement should help cardiologists distinguish HFrecEF from HFpEF, Dr. Mann noted. “Because EF is moving, we also have to emphasize the importance of following the trajectory of EF,” he said. “It’s not enough to know where the EF is; you have to know where it came from – if it had been from a higher number or a lower number – because that will help inform you about the patient’s disease.”

In that regard, the panel states that the level of change in LVEF – the “trajectory” – will provide clues to the nature and extent of myocardial injury, degree and duration of LV remodeling, and the type of therapy that’s indicated. Clinicians should consider HFmrEF, a description the European Society of Cardiology has endorsed, as an entity different from HFrecEF without data on LVEF trajectory.

The statement delves into the biology of HFrecEF, defining reverse LV remodeling as the restoration of some normalization to cardiac myocyte size and LV chamber geometry that results in a leftward shift toward normalization of end-diastolic pressure volume. The panel also noted that cardiac remodeling in reverse LV remodeling and recovery of LV function is bidirectional and involves multiple molecular and cellular changes that contribute to changes in the heart’s size, shape and function, and explains the role gene expression has in HF-related LV changes.

The statement explores the recovery of LV function, noting that spontaneous recovery often occurs when the cause of the myocardial dysfunction resolves. Common causes are chronic tachycardia and thyroid disease.

That panel noted that “super responders” to cardiac resynchronization therapy can provide insight into HFrecEF. Favorable responders include women, patients with nonischemic HF, very wide ECG ventricular depolarization wavelength with left-bundle branch block morphology, and dyssynchrony on ECG.

Bruce Jancin/MDedge News

The panel states that, “regardless of the definition of HFrecEF,” the evidence suggests that younger patients, women, and those with nonischemic disease, shorter disease duration, and relatively few comorbidities are more likely to recover LVEF – and their outcomes are typically better than those of patients with HF reduced EF (HFrEF) and HFpEF.

Clinicians should bear in mind, however, that patients on guideline-directed medical therapy (GDMT) who achieve complete normalization of LV structure and function are prone to recurrent LV dysfunction and HF. The panel explored the role of potential treatment for three different etiologies of HF. Little is known about Takotsubo cardiomyopathy, considered a transient form of LV dysfunction, in terms of how many of these patients will develop HFrEF or if they’ll benefit from GDMT. Alcohol-induced cardiomyopathy patients should continue on medical therapy even if they have HFrecEF, as should patients with fulminant and nonfulminant myocarditis.
 

Managing HFrecEF

Management should include assessment of jugular vein distention and signs of volume overload – “particularly concerning in HFrecEF” – the panel noted. ECG is cost effective, and signs of left-bundle branch block are predictors of low success with GDMT alone. The panel also recommended a family history going back three generations and consideration of genetic testing to determine the risk for sudden cardiac death. Two-dimensional ECG can help predict GDMT response and cardiovascular magnetic resonance imaging can provide information about myocardial substrate at the time of diagnosis of HFrEF.

The panel suggested four areas for future research: 1) improved phenotyping of HFrEF; 2) use of inception cohorts to better understand the natural history of HFrecEF; 3) clinical trials to better define those clinical care components most effective at maintaining remission; and 4) basic studies to better define the biology of HFrecEF. “The goal,” wrote Dr. Wilcox and colleagues, “is to develop new therapeutic targets that will enable patients with HFrecEF to experience a durable remission from HF.”

Dr. Wilcox reported receiving funding from the National Institutes of Health and the American Heart Association, and financial relationships with Abbott, Medtronic, and Cytokinetics. Dr. Mann has received funding from NIH and reports financial relationships with MyoKardia and Novartis. Coauthors reported funding from NIH and AHA and financial relationships with Novartis, Amgen, AstraZeneca, Thoratec Corporation (Abbott), Sanofi, Pfizer, MyoKardia and American Regent.

SOURCE: Wilcox JE et al. J Am Coll Cardiol. 2020;76:719-34.

Because heart failure patients with recovered ejection fraction are a complex and diverse group, little consensus has emerged on how to define, diagnose, and manage this growing population.

To provide some clarity for identifying and treating these patients, a Journal of the American College of Cardiology scientific expert panel has issued a consensus document. Published Aug. 3 in the Journal of the American College of Cardiology, it provides a working definition of heart failure with recovered ejection fraction (HFrecEF) and recommends approaches for treatment and follow-up.
 

Defining a new class of HF

“Part of the impetus of this was to bring attention to what we think is a new class of heart failure, and it requires different treatment modalities and different ways of thinking about it,” expert panel member Douglas L. Mann, MD, cardiologist-in-chief at Barnes Jewish Hospital in St. Louis, said in an interview. “It’s a newly discovered HF biology about which we know very little and it’s very confusing to just go on the ejection fraction alone.”

The panel, led by Jane E. Wilcox, MD, of Northwestern University, Chicago, recommends three components for a working definition of HFrecEF: 1) documentation of a decreased left ventricle ejection fraction (LVEF) of less than 40% at baseline; 2) a 10% or greater absolute improvement in LVEF; and 3) a second measurement of LVEF >40%.

“We try to give it a nomenclature that clearly indicates what it is,” Dr. Mann said. “There has been a lot of confusing terminology.” Among the terms the panel calls out in the lexicon of modestly recovered EF, in addition to HFrecEF, are HF improved EF, HF with preserved EF (HFpEF), borderline HFpEF and HF with mid-range EF (HFmrEF).

The panel also recommends that guideline-based medical and device therapies for HFrecEF should continue indefinitely until there’s a better understanding of the biology and clinical epidemiology of HFrecEF, and that these patients should have close clinical follow-up because of the high risk of HF relapse.

Determining EF’s ‘trajectory’

The findings presented in the statement should help cardiologists distinguish HFrecEF from HFpEF, Dr. Mann noted. “Because EF is moving, we also have to emphasize the importance of following the trajectory of EF,” he said. “It’s not enough to know where the EF is; you have to know where it came from – if it had been from a higher number or a lower number – because that will help inform you about the patient’s disease.”

In that regard, the panel states that the level of change in LVEF – the “trajectory” – will provide clues to the nature and extent of myocardial injury, degree and duration of LV remodeling, and the type of therapy that’s indicated. Clinicians should consider HFmrEF, a description the European Society of Cardiology has endorsed, as an entity different from HFrecEF without data on LVEF trajectory.

The statement delves into the biology of HFrecEF, defining reverse LV remodeling as the restoration of some normalization to cardiac myocyte size and LV chamber geometry that results in a leftward shift toward normalization of end-diastolic pressure volume. The panel also noted that cardiac remodeling in reverse LV remodeling and recovery of LV function is bidirectional and involves multiple molecular and cellular changes that contribute to changes in the heart’s size, shape and function, and explains the role gene expression has in HF-related LV changes.

The statement explores the recovery of LV function, noting that spontaneous recovery often occurs when the cause of the myocardial dysfunction resolves. Common causes are chronic tachycardia and thyroid disease.

That panel noted that “super responders” to cardiac resynchronization therapy can provide insight into HFrecEF. Favorable responders include women, patients with nonischemic HF, very wide ECG ventricular depolarization wavelength with left-bundle branch block morphology, and dyssynchrony on ECG.

Bruce Jancin/MDedge News

The panel states that, “regardless of the definition of HFrecEF,” the evidence suggests that younger patients, women, and those with nonischemic disease, shorter disease duration, and relatively few comorbidities are more likely to recover LVEF – and their outcomes are typically better than those of patients with HF reduced EF (HFrEF) and HFpEF.

Clinicians should bear in mind, however, that patients on guideline-directed medical therapy (GDMT) who achieve complete normalization of LV structure and function are prone to recurrent LV dysfunction and HF. The panel explored the role of potential treatment for three different etiologies of HF. Little is known about Takotsubo cardiomyopathy, considered a transient form of LV dysfunction, in terms of how many of these patients will develop HFrEF or if they’ll benefit from GDMT. Alcohol-induced cardiomyopathy patients should continue on medical therapy even if they have HFrecEF, as should patients with fulminant and nonfulminant myocarditis.
 

Managing HFrecEF

Management should include assessment of jugular vein distention and signs of volume overload – “particularly concerning in HFrecEF” – the panel noted. ECG is cost effective, and signs of left-bundle branch block are predictors of low success with GDMT alone. The panel also recommended a family history going back three generations and consideration of genetic testing to determine the risk for sudden cardiac death. Two-dimensional ECG can help predict GDMT response and cardiovascular magnetic resonance imaging can provide information about myocardial substrate at the time of diagnosis of HFrEF.

The panel suggested four areas for future research: 1) improved phenotyping of HFrEF; 2) use of inception cohorts to better understand the natural history of HFrecEF; 3) clinical trials to better define those clinical care components most effective at maintaining remission; and 4) basic studies to better define the biology of HFrecEF. “The goal,” wrote Dr. Wilcox and colleagues, “is to develop new therapeutic targets that will enable patients with HFrecEF to experience a durable remission from HF.”

Dr. Wilcox reported receiving funding from the National Institutes of Health and the American Heart Association, and financial relationships with Abbott, Medtronic, and Cytokinetics. Dr. Mann has received funding from NIH and reports financial relationships with MyoKardia and Novartis. Coauthors reported funding from NIH and AHA and financial relationships with Novartis, Amgen, AstraZeneca, Thoratec Corporation (Abbott), Sanofi, Pfizer, MyoKardia and American Regent.

SOURCE: Wilcox JE et al. J Am Coll Cardiol. 2020;76:719-34.

Because heart failure patients with recovered ejection fraction are a complex and diverse group, little consensus has emerged on how to define, diagnose, and manage this growing population.

To provide some clarity for identifying and treating these patients, a Journal of the American College of Cardiology scientific expert panel has issued a consensus document. Published Aug. 3 in the Journal of the American College of Cardiology, it provides a working definition of heart failure with recovered ejection fraction (HFrecEF) and recommends approaches for treatment and follow-up.
 

Defining a new class of HF

“Part of the impetus of this was to bring attention to what we think is a new class of heart failure, and it requires different treatment modalities and different ways of thinking about it,” expert panel member Douglas L. Mann, MD, cardiologist-in-chief at Barnes Jewish Hospital in St. Louis, said in an interview. “It’s a newly discovered HF biology about which we know very little and it’s very confusing to just go on the ejection fraction alone.”

The panel, led by Jane E. Wilcox, MD, of Northwestern University, Chicago, recommends three components for a working definition of HFrecEF: 1) documentation of a decreased left ventricle ejection fraction (LVEF) of less than 40% at baseline; 2) a 10% or greater absolute improvement in LVEF; and 3) a second measurement of LVEF >40%.

“We try to give it a nomenclature that clearly indicates what it is,” Dr. Mann said. “There has been a lot of confusing terminology.” Among the terms the panel calls out in the lexicon of modestly recovered EF, in addition to HFrecEF, are HF improved EF, HF with preserved EF (HFpEF), borderline HFpEF and HF with mid-range EF (HFmrEF).

The panel also recommends that guideline-based medical and device therapies for HFrecEF should continue indefinitely until there’s a better understanding of the biology and clinical epidemiology of HFrecEF, and that these patients should have close clinical follow-up because of the high risk of HF relapse.

Determining EF’s ‘trajectory’

The findings presented in the statement should help cardiologists distinguish HFrecEF from HFpEF, Dr. Mann noted. “Because EF is moving, we also have to emphasize the importance of following the trajectory of EF,” he said. “It’s not enough to know where the EF is; you have to know where it came from – if it had been from a higher number or a lower number – because that will help inform you about the patient’s disease.”

In that regard, the panel states that the level of change in LVEF – the “trajectory” – will provide clues to the nature and extent of myocardial injury, degree and duration of LV remodeling, and the type of therapy that’s indicated. Clinicians should consider HFmrEF, a description the European Society of Cardiology has endorsed, as an entity different from HFrecEF without data on LVEF trajectory.

The statement delves into the biology of HFrecEF, defining reverse LV remodeling as the restoration of some normalization to cardiac myocyte size and LV chamber geometry that results in a leftward shift toward normalization of end-diastolic pressure volume. The panel also noted that cardiac remodeling in reverse LV remodeling and recovery of LV function is bidirectional and involves multiple molecular and cellular changes that contribute to changes in the heart’s size, shape and function, and explains the role gene expression has in HF-related LV changes.

The statement explores the recovery of LV function, noting that spontaneous recovery often occurs when the cause of the myocardial dysfunction resolves. Common causes are chronic tachycardia and thyroid disease.

That panel noted that “super responders” to cardiac resynchronization therapy can provide insight into HFrecEF. Favorable responders include women, patients with nonischemic HF, very wide ECG ventricular depolarization wavelength with left-bundle branch block morphology, and dyssynchrony on ECG.

Bruce Jancin/MDedge News

The panel states that, “regardless of the definition of HFrecEF,” the evidence suggests that younger patients, women, and those with nonischemic disease, shorter disease duration, and relatively few comorbidities are more likely to recover LVEF – and their outcomes are typically better than those of patients with HF reduced EF (HFrEF) and HFpEF.

Clinicians should bear in mind, however, that patients on guideline-directed medical therapy (GDMT) who achieve complete normalization of LV structure and function are prone to recurrent LV dysfunction and HF. The panel explored the role of potential treatment for three different etiologies of HF. Little is known about Takotsubo cardiomyopathy, considered a transient form of LV dysfunction, in terms of how many of these patients will develop HFrEF or if they’ll benefit from GDMT. Alcohol-induced cardiomyopathy patients should continue on medical therapy even if they have HFrecEF, as should patients with fulminant and nonfulminant myocarditis.
 

Managing HFrecEF

Management should include assessment of jugular vein distention and signs of volume overload – “particularly concerning in HFrecEF” – the panel noted. ECG is cost effective, and signs of left-bundle branch block are predictors of low success with GDMT alone. The panel also recommended a family history going back three generations and consideration of genetic testing to determine the risk for sudden cardiac death. Two-dimensional ECG can help predict GDMT response and cardiovascular magnetic resonance imaging can provide information about myocardial substrate at the time of diagnosis of HFrEF.

The panel suggested four areas for future research: 1) improved phenotyping of HFrEF; 2) use of inception cohorts to better understand the natural history of HFrecEF; 3) clinical trials to better define those clinical care components most effective at maintaining remission; and 4) basic studies to better define the biology of HFrecEF. “The goal,” wrote Dr. Wilcox and colleagues, “is to develop new therapeutic targets that will enable patients with HFrecEF to experience a durable remission from HF.”

Dr. Wilcox reported receiving funding from the National Institutes of Health and the American Heart Association, and financial relationships with Abbott, Medtronic, and Cytokinetics. Dr. Mann has received funding from NIH and reports financial relationships with MyoKardia and Novartis. Coauthors reported funding from NIH and AHA and financial relationships with Novartis, Amgen, AstraZeneca, Thoratec Corporation (Abbott), Sanofi, Pfizer, MyoKardia and American Regent.

SOURCE: Wilcox JE et al. J Am Coll Cardiol. 2020;76:719-34.

Polycystic ovarian syndrome (PCOS) was associated with a nearly doubled risk of developing psoriasis in a propensity score–matched analysis conducted in Taiwan.

PCOS is characterized by androgen elevation that can lead to insulin resistance and metabolic syndrome, which have also been associated with an increased risk of psoriasis. Previous retrospective analyses have suggested an increased risk of psoriasis associated with PCOS, and psoriasis patients with PCOS have been reported to have more severe skin lesions, compared with those who do not have PCOS.

“The incidence of psoriasis is indeed higher in the PCOS group than in the control group, and the comorbidities related to metabolic syndrome did not modify the adjusted hazard ratio,” said Ming-Li Chen, during her presentation of the study results at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. Dr. Chen is at Chung Shan Medical University in Taiwan.

The researchers analyzed 1 million randomly selected records from Taiwan’s Longitudinal Health Insurance database, a subset of the country’s National Health Insurance Program. Between 2000 and 2012, they identified a case group with at least three outpatient diagnoses or one inpatient diagnosis of PCOS; they then compared each with four patients who did not have PCOS who were matched by age and index year. The mean age in both groups was about 27 years.

The mean follow-up times were 6.99 years for 4,707 cases and 6.94 years for 18,828 controls. Comorbidities were slightly higher in the PCOS group, including asthma (6.7% vs. 4.9%; P less than .001), chronic obstructive pulmonary disease (14% vs. 11%; P less than .001), chronic liver disease (8.0% vs. 5.0%; P less than .001), diabetes mellitus (3.0% vs. 1.4%; P less than .001), hypertension (2.4% vs. 1.5%; P less than .001), hyperlipidemia (5.4% vs. 2.5%; P less than .001), depression (5.4% vs. 3.9%; P less than .001), and sleep apnea (0.23% vs. 0.10%; P = .040).

There was a higher cumulative incidence of psoriasis in the PCOS group (adjusted hazard ratio, 2.07; 95% confidence interval, 1.25-3.44). Other factors associated with increased risk of psoriasis were advanced age (greater than 50 years old; aHR, 14.13; 95% CI, 1.8-110.7) and having a cancer diagnosis (aHR, 11.72; 95% CI, 2.87-47.9).

When PCOS patients were stratified by age, the researchers noted a higher risk of psoriasis among those 20 years or younger (aHR, 4.02; 95% CI, 1.16-13.9) than among those aged 20-50 years (aHR, 1.88; 95% CI, 1.07-3.29). Among those older than 50 years, there was no significantly increased risk, although the number of psoriasis diagnoses and population sizes were small in the latter category. Among patients with PCOS, a cancer diagnosis was not associated with a statistically significant increased risk of psoriasis.

The mechanisms underlying the association between PCOS and psoriasis should be studied further, she noted.

Following Dr. Chen’s prerecorded presentation, there was a live discussion session led by Alice Gottlieb, MD, PhD, medical director of Mount Sinai Beth Israel Dermatology, New York, and Ennio Lubrano, MD, associate professor of rheumatology at the University of Molise (Italy). Dr. Gottlieb noted that the study did not appear to account for weight in the association between PCOS and psoriasis, since heavier people are known to be at greater risk of developing psoriasis. Dr. Chen acknowledged that the study had no records of BMI or weight.

Dr. Gottlieb also wondered if treatment of PCOS led to any improvements in psoriasis in patients with the two diagnoses. “If we treat PCOS, does the psoriasis get better?” Again, the study did not address the question. “We didn’t follow up on therapies,” Dr. Chen said.

Dr. Chen reported no relevant financial disclosures. Dr. Gottlieb is a consultant, advisory board member and/or speaker for AbbVie, Allergan, Avotres Therapeutics, Beiersdorf, Bristol-Myers Squibb, Celgene, Dermira, Eli Lilly, Incyte, Janssen, Leo, Novartis, Reddy Labs, Sun Pharmaceutical Industries, UCB Pharma and Xbiotech. She has received research or educational grants from Boehringer Ingelheim, Incyte, Janssen, Novartis and Xbiotech.

Polycystic ovarian syndrome (PCOS) was associated with a nearly doubled risk of developing psoriasis in a propensity score–matched analysis conducted in Taiwan.

PCOS is characterized by androgen elevation that can lead to insulin resistance and metabolic syndrome, which have also been associated with an increased risk of psoriasis. Previous retrospective analyses have suggested an increased risk of psoriasis associated with PCOS, and psoriasis patients with PCOS have been reported to have more severe skin lesions, compared with those who do not have PCOS.

“The incidence of psoriasis is indeed higher in the PCOS group than in the control group, and the comorbidities related to metabolic syndrome did not modify the adjusted hazard ratio,” said Ming-Li Chen, during her presentation of the study results at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. Dr. Chen is at Chung Shan Medical University in Taiwan.

The researchers analyzed 1 million randomly selected records from Taiwan’s Longitudinal Health Insurance database, a subset of the country’s National Health Insurance Program. Between 2000 and 2012, they identified a case group with at least three outpatient diagnoses or one inpatient diagnosis of PCOS; they then compared each with four patients who did not have PCOS who were matched by age and index year. The mean age in both groups was about 27 years.

The mean follow-up times were 6.99 years for 4,707 cases and 6.94 years for 18,828 controls. Comorbidities were slightly higher in the PCOS group, including asthma (6.7% vs. 4.9%; P less than .001), chronic obstructive pulmonary disease (14% vs. 11%; P less than .001), chronic liver disease (8.0% vs. 5.0%; P less than .001), diabetes mellitus (3.0% vs. 1.4%; P less than .001), hypertension (2.4% vs. 1.5%; P less than .001), hyperlipidemia (5.4% vs. 2.5%; P less than .001), depression (5.4% vs. 3.9%; P less than .001), and sleep apnea (0.23% vs. 0.10%; P = .040).

There was a higher cumulative incidence of psoriasis in the PCOS group (adjusted hazard ratio, 2.07; 95% confidence interval, 1.25-3.44). Other factors associated with increased risk of psoriasis were advanced age (greater than 50 years old; aHR, 14.13; 95% CI, 1.8-110.7) and having a cancer diagnosis (aHR, 11.72; 95% CI, 2.87-47.9).

When PCOS patients were stratified by age, the researchers noted a higher risk of psoriasis among those 20 years or younger (aHR, 4.02; 95% CI, 1.16-13.9) than among those aged 20-50 years (aHR, 1.88; 95% CI, 1.07-3.29). Among those older than 50 years, there was no significantly increased risk, although the number of psoriasis diagnoses and population sizes were small in the latter category. Among patients with PCOS, a cancer diagnosis was not associated with a statistically significant increased risk of psoriasis.

The mechanisms underlying the association between PCOS and psoriasis should be studied further, she noted.

Following Dr. Chen’s prerecorded presentation, there was a live discussion session led by Alice Gottlieb, MD, PhD, medical director of Mount Sinai Beth Israel Dermatology, New York, and Ennio Lubrano, MD, associate professor of rheumatology at the University of Molise (Italy). Dr. Gottlieb noted that the study did not appear to account for weight in the association between PCOS and psoriasis, since heavier people are known to be at greater risk of developing psoriasis. Dr. Chen acknowledged that the study had no records of BMI or weight.

Dr. Gottlieb also wondered if treatment of PCOS led to any improvements in psoriasis in patients with the two diagnoses. “If we treat PCOS, does the psoriasis get better?” Again, the study did not address the question. “We didn’t follow up on therapies,” Dr. Chen said.

Dr. Chen reported no relevant financial disclosures. Dr. Gottlieb is a consultant, advisory board member and/or speaker for AbbVie, Allergan, Avotres Therapeutics, Beiersdorf, Bristol-Myers Squibb, Celgene, Dermira, Eli Lilly, Incyte, Janssen, Leo, Novartis, Reddy Labs, Sun Pharmaceutical Industries, UCB Pharma and Xbiotech. She has received research or educational grants from Boehringer Ingelheim, Incyte, Janssen, Novartis and Xbiotech.

Polycystic ovarian syndrome (PCOS) was associated with a nearly doubled risk of developing psoriasis in a propensity score–matched analysis conducted in Taiwan.

PCOS is characterized by androgen elevation that can lead to insulin resistance and metabolic syndrome, which have also been associated with an increased risk of psoriasis. Previous retrospective analyses have suggested an increased risk of psoriasis associated with PCOS, and psoriasis patients with PCOS have been reported to have more severe skin lesions, compared with those who do not have PCOS.

“The incidence of psoriasis is indeed higher in the PCOS group than in the control group, and the comorbidities related to metabolic syndrome did not modify the adjusted hazard ratio,” said Ming-Li Chen, during her presentation of the study results at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. Dr. Chen is at Chung Shan Medical University in Taiwan.

The researchers analyzed 1 million randomly selected records from Taiwan’s Longitudinal Health Insurance database, a subset of the country’s National Health Insurance Program. Between 2000 and 2012, they identified a case group with at least three outpatient diagnoses or one inpatient diagnosis of PCOS; they then compared each with four patients who did not have PCOS who were matched by age and index year. The mean age in both groups was about 27 years.

The mean follow-up times were 6.99 years for 4,707 cases and 6.94 years for 18,828 controls. Comorbidities were slightly higher in the PCOS group, including asthma (6.7% vs. 4.9%; P less than .001), chronic obstructive pulmonary disease (14% vs. 11%; P less than .001), chronic liver disease (8.0% vs. 5.0%; P less than .001), diabetes mellitus (3.0% vs. 1.4%; P less than .001), hypertension (2.4% vs. 1.5%; P less than .001), hyperlipidemia (5.4% vs. 2.5%; P less than .001), depression (5.4% vs. 3.9%; P less than .001), and sleep apnea (0.23% vs. 0.10%; P = .040).

There was a higher cumulative incidence of psoriasis in the PCOS group (adjusted hazard ratio, 2.07; 95% confidence interval, 1.25-3.44). Other factors associated with increased risk of psoriasis were advanced age (greater than 50 years old; aHR, 14.13; 95% CI, 1.8-110.7) and having a cancer diagnosis (aHR, 11.72; 95% CI, 2.87-47.9).

When PCOS patients were stratified by age, the researchers noted a higher risk of psoriasis among those 20 years or younger (aHR, 4.02; 95% CI, 1.16-13.9) than among those aged 20-50 years (aHR, 1.88; 95% CI, 1.07-3.29). Among those older than 50 years, there was no significantly increased risk, although the number of psoriasis diagnoses and population sizes were small in the latter category. Among patients with PCOS, a cancer diagnosis was not associated with a statistically significant increased risk of psoriasis.

The mechanisms underlying the association between PCOS and psoriasis should be studied further, she noted.

Following Dr. Chen’s prerecorded presentation, there was a live discussion session led by Alice Gottlieb, MD, PhD, medical director of Mount Sinai Beth Israel Dermatology, New York, and Ennio Lubrano, MD, associate professor of rheumatology at the University of Molise (Italy). Dr. Gottlieb noted that the study did not appear to account for weight in the association between PCOS and psoriasis, since heavier people are known to be at greater risk of developing psoriasis. Dr. Chen acknowledged that the study had no records of BMI or weight.

Dr. Gottlieb also wondered if treatment of PCOS led to any improvements in psoriasis in patients with the two diagnoses. “If we treat PCOS, does the psoriasis get better?” Again, the study did not address the question. “We didn’t follow up on therapies,” Dr. Chen said.

Dr. Chen reported no relevant financial disclosures. Dr. Gottlieb is a consultant, advisory board member and/or speaker for AbbVie, Allergan, Avotres Therapeutics, Beiersdorf, Bristol-Myers Squibb, Celgene, Dermira, Eli Lilly, Incyte, Janssen, Leo, Novartis, Reddy Labs, Sun Pharmaceutical Industries, UCB Pharma and Xbiotech. She has received research or educational grants from Boehringer Ingelheim, Incyte, Janssen, Novartis and Xbiotech.

Safe and effective new prescription topical therapies for primary axillary hyperhidrosis took a giant step closer to reaching clinical practice following positive reports from two phase 3, randomized, controlled trials of novel agents presented at the virtual annual meeting of the American Academy of Dermatology.

simarik/iStock/Getty Images

Both investigational topical anticholinergic agents – 5% sofpironium bromide (SPB) gel and 1% glycopyrronium bromide (GPB) cream – met all of the efficacy and safety endpoints required by the Food and Drug Administration.

Primary axillary hyperhidrosis, or symmetrical bilateral excessive armpit sweating, has a prevalence worldwide of 1%-16%, with 5%-6% the most frequently cited numbers. The condition has a strong adverse impact on quality of life. Primary axillary hyperhidrosis is not caused by a disorder of the sweat glands; rather, it’s actually a dysregulation of the autonomic nervous system leading to disproportionate sweating, explained Christoph Abels, MD, PhD, medical director at Dr. August Wolff in Bielefeld, Germany.

“What’s surprising is that more than 50% of patients do not receive appropriate treatment, very likely due to lack of awareness or embarrassment,” he added.

Also, many patients are put off by the systemic side effects of the oral anticholinergic agents, which are the current off-label treatment mainstay for patients with moderate or severe disease, according to Tomoko Fujimoto, MD, PhD, director of Ikebukuro Nishiguchi Fukurou Dermatology, near Tokyo.
 

Sofpironium bromide gel

Dr. Fujimoto presented the results of a phase 3, double-blind, multicenter, 6-week, vehicle-controlled clinical trial conducted in 281 Japanese patients with moderate to severe primary axillary hyperhidrosis as defined by a baseline score of 3 or 4 on the 4-point Hyperhidrosis Disease Severity Scale (HDSS). Participants were randomized to self-application of 5% SPB gel or its vehicle once daily before bedtime.

Sofpironium bromide blocks the cholinergic response mediated by the M3 muscarinic receptor subtype expressed on eccrine sweat glands, thereby inhibiting sweating. The drug then undergoes breakdown into an inactive metabolite after reaching the blood.

An important aspect of both SPB gel and GPB cream is that these agents are rolled onto the axillae using a dedicated applicator. Patients never touch the medications with their hands, thus avoiding accidental exposure to the mucous membranes. This largely prevents problems with mydriasis and blurred vision as anticholinergic side effects, which has been an issue with glycopyrronium tosylate topical cloth wipes (Qbrexza), the first FDA-approved treatment for primary axillary hyperhidrosis.

The primary endpoint in the Japanese study was at least a 1-point improvement on the HDSS plus at least a 50% reduction in gravimetric sweat production between baseline and week 6. This composite outcome was achieved in 53.9% of patients in the active treatment arm, compared with 36.4% of controls.

The secondary endpoint consisting of a week-6 HDSS score of 1 or 2 – that is, underarm sweating that’s either never noticeable or is tolerable – occurred in 60.3% of the sofpironium bromide group and 47.9% of controls, a between-group difference that achieved statistical significance by week 2, when the rates were 46.8% and 28.2%.

The reduction in total gravimetric weight of axillary sweat from a mean baseline of 227 mg collected over 5 minutes was also significantly greater in the SPB group: a decrease of 157.6 mg, compared with 127.6 mg in controls; a between-group difference that also was significant by week 2. The mean Dermatology Life Quality Index score dropped by 6.8 points in the active-treatment arm from a baseline of 11.3, a significant improvement over the mean 4.5-point drop in controls.

A new 5-point measure of subjective symptoms of primary axillary hyperhidrosis – the Hyperhidrosis Disease Severity Measure–Axilla (HDSM-Ax) – improved by 1.41 points in the SPB group, significantly better than the 0.93 points in vehicle-treated controls. About 48% of patients on SBP experienced at least a 1.5-point reduction on the HDSM-Ax, compared with 26% of controls.

Regarding safety, there was a 2% incidence of application-site itch or scale in the SBP group. Anticholinergic side effects consisted of a single case of mydriasis, another of constipation, and two complaints of thirst, all mild, none resulting in treatment discontinuation. There were no reports of headache or blurred vision.

“These results indicate that the safety risks of sofpironium bromide can be considered small and controllable,” Dr. Fujimoto said. “Moreover, sofpironium bromide is a topical agent that patients can use by themselves, so it is highly convenient, unlike, say, botulinum toxin type A injections.”

Glycopyrronium bromide cream

Following on the heels of a recently published dose-ranging study (Br J Dermatol. 2020 Jan;182[1]:229-231), Dr. Abels presented the 4-week outcomes of a phase 3a, double-blind, randomized, five-country trial of once-daily 1% GPB cream or placebo in 171 patients with moderate or severe primary axillary hyperhidrosis. A phase 3b, open-label, 72-week, long-term safety trial is ongoing in 516 patients.

The primary endpoint of the 4-week trial was the reduction in gravimetric sweat production from day 1 to day 29. A reduction of 50% or more was documented in 57.5% of the patients on GBP and 34.5% of controls. A 75% or greater reduction occurred in 32.2% of the active-treatment group and 16.7% of those on placebo. And a decrease of at least 90% was seen in 23% of patients on topical GBP, compared with 9.5% of controls. All these between-group differences were significant.

The FDA now requires a quality of life measurement as a coprimary endpoint in phase 3 hyperhidrosis studies, and the phase 3 GBP trial also served as the successful validation study for a new patient-reported quality of life instrument designed specifically for this purpose. The new tool, known as the Hyperhydrosis Quality of Life questionnaire (HidroQol), proved much more sensitive than the HDSS or DLQI for evaluating clinical improvement in response to treatment (Br J Dermatol. 2020 Jun 8. doi: 10.1111/bjd.19300).

Initial results from the long-term phase 3b safety study should be available this fall on the first 100 patients followed on topical GBP for 1 year and for 300 followed for 6 months, Dr. Abels said.

Dr. Fujimoto reported serving as a paid consultant to and speaker for Kaken Pharmaceutical, which is developing SBP gel with Brickell Biotech. Dr. Abels is an employee of the company that is developing GPB cream.

[email protected]

Safe and effective new prescription topical therapies for primary axillary hyperhidrosis took a giant step closer to reaching clinical practice following positive reports from two phase 3, randomized, controlled trials of novel agents presented at the virtual annual meeting of the American Academy of Dermatology.

simarik/iStock/Getty Images

Both investigational topical anticholinergic agents – 5% sofpironium bromide (SPB) gel and 1% glycopyrronium bromide (GPB) cream – met all of the efficacy and safety endpoints required by the Food and Drug Administration.

Primary axillary hyperhidrosis, or symmetrical bilateral excessive armpit sweating, has a prevalence worldwide of 1%-16%, with 5%-6% the most frequently cited numbers. The condition has a strong adverse impact on quality of life. Primary axillary hyperhidrosis is not caused by a disorder of the sweat glands; rather, it’s actually a dysregulation of the autonomic nervous system leading to disproportionate sweating, explained Christoph Abels, MD, PhD, medical director at Dr. August Wolff in Bielefeld, Germany.

“What’s surprising is that more than 50% of patients do not receive appropriate treatment, very likely due to lack of awareness or embarrassment,” he added.

Also, many patients are put off by the systemic side effects of the oral anticholinergic agents, which are the current off-label treatment mainstay for patients with moderate or severe disease, according to Tomoko Fujimoto, MD, PhD, director of Ikebukuro Nishiguchi Fukurou Dermatology, near Tokyo.
 

Sofpironium bromide gel

Dr. Fujimoto presented the results of a phase 3, double-blind, multicenter, 6-week, vehicle-controlled clinical trial conducted in 281 Japanese patients with moderate to severe primary axillary hyperhidrosis as defined by a baseline score of 3 or 4 on the 4-point Hyperhidrosis Disease Severity Scale (HDSS). Participants were randomized to self-application of 5% SPB gel or its vehicle once daily before bedtime.

Sofpironium bromide blocks the cholinergic response mediated by the M3 muscarinic receptor subtype expressed on eccrine sweat glands, thereby inhibiting sweating. The drug then undergoes breakdown into an inactive metabolite after reaching the blood.

An important aspect of both SPB gel and GPB cream is that these agents are rolled onto the axillae using a dedicated applicator. Patients never touch the medications with their hands, thus avoiding accidental exposure to the mucous membranes. This largely prevents problems with mydriasis and blurred vision as anticholinergic side effects, which has been an issue with glycopyrronium tosylate topical cloth wipes (Qbrexza), the first FDA-approved treatment for primary axillary hyperhidrosis.

The primary endpoint in the Japanese study was at least a 1-point improvement on the HDSS plus at least a 50% reduction in gravimetric sweat production between baseline and week 6. This composite outcome was achieved in 53.9% of patients in the active treatment arm, compared with 36.4% of controls.

The secondary endpoint consisting of a week-6 HDSS score of 1 or 2 – that is, underarm sweating that’s either never noticeable or is tolerable – occurred in 60.3% of the sofpironium bromide group and 47.9% of controls, a between-group difference that achieved statistical significance by week 2, when the rates were 46.8% and 28.2%.

The reduction in total gravimetric weight of axillary sweat from a mean baseline of 227 mg collected over 5 minutes was also significantly greater in the SPB group: a decrease of 157.6 mg, compared with 127.6 mg in controls; a between-group difference that also was significant by week 2. The mean Dermatology Life Quality Index score dropped by 6.8 points in the active-treatment arm from a baseline of 11.3, a significant improvement over the mean 4.5-point drop in controls.

A new 5-point measure of subjective symptoms of primary axillary hyperhidrosis – the Hyperhidrosis Disease Severity Measure–Axilla (HDSM-Ax) – improved by 1.41 points in the SPB group, significantly better than the 0.93 points in vehicle-treated controls. About 48% of patients on SBP experienced at least a 1.5-point reduction on the HDSM-Ax, compared with 26% of controls.

Regarding safety, there was a 2% incidence of application-site itch or scale in the SBP group. Anticholinergic side effects consisted of a single case of mydriasis, another of constipation, and two complaints of thirst, all mild, none resulting in treatment discontinuation. There were no reports of headache or blurred vision.

“These results indicate that the safety risks of sofpironium bromide can be considered small and controllable,” Dr. Fujimoto said. “Moreover, sofpironium bromide is a topical agent that patients can use by themselves, so it is highly convenient, unlike, say, botulinum toxin type A injections.”

Glycopyrronium bromide cream

Following on the heels of a recently published dose-ranging study (Br J Dermatol. 2020 Jan;182[1]:229-231), Dr. Abels presented the 4-week outcomes of a phase 3a, double-blind, randomized, five-country trial of once-daily 1% GPB cream or placebo in 171 patients with moderate or severe primary axillary hyperhidrosis. A phase 3b, open-label, 72-week, long-term safety trial is ongoing in 516 patients.

The primary endpoint of the 4-week trial was the reduction in gravimetric sweat production from day 1 to day 29. A reduction of 50% or more was documented in 57.5% of the patients on GBP and 34.5% of controls. A 75% or greater reduction occurred in 32.2% of the active-treatment group and 16.7% of those on placebo. And a decrease of at least 90% was seen in 23% of patients on topical GBP, compared with 9.5% of controls. All these between-group differences were significant.

The FDA now requires a quality of life measurement as a coprimary endpoint in phase 3 hyperhidrosis studies, and the phase 3 GBP trial also served as the successful validation study for a new patient-reported quality of life instrument designed specifically for this purpose. The new tool, known as the Hyperhydrosis Quality of Life questionnaire (HidroQol), proved much more sensitive than the HDSS or DLQI for evaluating clinical improvement in response to treatment (Br J Dermatol. 2020 Jun 8. doi: 10.1111/bjd.19300).

Initial results from the long-term phase 3b safety study should be available this fall on the first 100 patients followed on topical GBP for 1 year and for 300 followed for 6 months, Dr. Abels said.

Dr. Fujimoto reported serving as a paid consultant to and speaker for Kaken Pharmaceutical, which is developing SBP gel with Brickell Biotech. Dr. Abels is an employee of the company that is developing GPB cream.

[email protected]

Safe and effective new prescription topical therapies for primary axillary hyperhidrosis took a giant step closer to reaching clinical practice following positive reports from two phase 3, randomized, controlled trials of novel agents presented at the virtual annual meeting of the American Academy of Dermatology.

simarik/iStock/Getty Images

Both investigational topical anticholinergic agents – 5% sofpironium bromide (SPB) gel and 1% glycopyrronium bromide (GPB) cream – met all of the efficacy and safety endpoints required by the Food and Drug Administration.

Primary axillary hyperhidrosis, or symmetrical bilateral excessive armpit sweating, has a prevalence worldwide of 1%-16%, with 5%-6% the most frequently cited numbers. The condition has a strong adverse impact on quality of life. Primary axillary hyperhidrosis is not caused by a disorder of the sweat glands; rather, it’s actually a dysregulation of the autonomic nervous system leading to disproportionate sweating, explained Christoph Abels, MD, PhD, medical director at Dr. August Wolff in Bielefeld, Germany.

“What’s surprising is that more than 50% of patients do not receive appropriate treatment, very likely due to lack of awareness or embarrassment,” he added.

Also, many patients are put off by the systemic side effects of the oral anticholinergic agents, which are the current off-label treatment mainstay for patients with moderate or severe disease, according to Tomoko Fujimoto, MD, PhD, director of Ikebukuro Nishiguchi Fukurou Dermatology, near Tokyo.
 

Sofpironium bromide gel

Dr. Fujimoto presented the results of a phase 3, double-blind, multicenter, 6-week, vehicle-controlled clinical trial conducted in 281 Japanese patients with moderate to severe primary axillary hyperhidrosis as defined by a baseline score of 3 or 4 on the 4-point Hyperhidrosis Disease Severity Scale (HDSS). Participants were randomized to self-application of 5% SPB gel or its vehicle once daily before bedtime.

Sofpironium bromide blocks the cholinergic response mediated by the M3 muscarinic receptor subtype expressed on eccrine sweat glands, thereby inhibiting sweating. The drug then undergoes breakdown into an inactive metabolite after reaching the blood.

An important aspect of both SPB gel and GPB cream is that these agents are rolled onto the axillae using a dedicated applicator. Patients never touch the medications with their hands, thus avoiding accidental exposure to the mucous membranes. This largely prevents problems with mydriasis and blurred vision as anticholinergic side effects, which has been an issue with glycopyrronium tosylate topical cloth wipes (Qbrexza), the first FDA-approved treatment for primary axillary hyperhidrosis.

The primary endpoint in the Japanese study was at least a 1-point improvement on the HDSS plus at least a 50% reduction in gravimetric sweat production between baseline and week 6. This composite outcome was achieved in 53.9% of patients in the active treatment arm, compared with 36.4% of controls.

The secondary endpoint consisting of a week-6 HDSS score of 1 or 2 – that is, underarm sweating that’s either never noticeable or is tolerable – occurred in 60.3% of the sofpironium bromide group and 47.9% of controls, a between-group difference that achieved statistical significance by week 2, when the rates were 46.8% and 28.2%.

The reduction in total gravimetric weight of axillary sweat from a mean baseline of 227 mg collected over 5 minutes was also significantly greater in the SPB group: a decrease of 157.6 mg, compared with 127.6 mg in controls; a between-group difference that also was significant by week 2. The mean Dermatology Life Quality Index score dropped by 6.8 points in the active-treatment arm from a baseline of 11.3, a significant improvement over the mean 4.5-point drop in controls.

A new 5-point measure of subjective symptoms of primary axillary hyperhidrosis – the Hyperhidrosis Disease Severity Measure–Axilla (HDSM-Ax) – improved by 1.41 points in the SPB group, significantly better than the 0.93 points in vehicle-treated controls. About 48% of patients on SBP experienced at least a 1.5-point reduction on the HDSM-Ax, compared with 26% of controls.

Regarding safety, there was a 2% incidence of application-site itch or scale in the SBP group. Anticholinergic side effects consisted of a single case of mydriasis, another of constipation, and two complaints of thirst, all mild, none resulting in treatment discontinuation. There were no reports of headache or blurred vision.

“These results indicate that the safety risks of sofpironium bromide can be considered small and controllable,” Dr. Fujimoto said. “Moreover, sofpironium bromide is a topical agent that patients can use by themselves, so it is highly convenient, unlike, say, botulinum toxin type A injections.”

Glycopyrronium bromide cream

Following on the heels of a recently published dose-ranging study (Br J Dermatol. 2020 Jan;182[1]:229-231), Dr. Abels presented the 4-week outcomes of a phase 3a, double-blind, randomized, five-country trial of once-daily 1% GPB cream or placebo in 171 patients with moderate or severe primary axillary hyperhidrosis. A phase 3b, open-label, 72-week, long-term safety trial is ongoing in 516 patients.

The primary endpoint of the 4-week trial was the reduction in gravimetric sweat production from day 1 to day 29. A reduction of 50% or more was documented in 57.5% of the patients on GBP and 34.5% of controls. A 75% or greater reduction occurred in 32.2% of the active-treatment group and 16.7% of those on placebo. And a decrease of at least 90% was seen in 23% of patients on topical GBP, compared with 9.5% of controls. All these between-group differences were significant.

The FDA now requires a quality of life measurement as a coprimary endpoint in phase 3 hyperhidrosis studies, and the phase 3 GBP trial also served as the successful validation study for a new patient-reported quality of life instrument designed specifically for this purpose. The new tool, known as the Hyperhydrosis Quality of Life questionnaire (HidroQol), proved much more sensitive than the HDSS or DLQI for evaluating clinical improvement in response to treatment (Br J Dermatol. 2020 Jun 8. doi: 10.1111/bjd.19300).

Initial results from the long-term phase 3b safety study should be available this fall on the first 100 patients followed on topical GBP for 1 year and for 300 followed for 6 months, Dr. Abels said.

Dr. Fujimoto reported serving as a paid consultant to and speaker for Kaken Pharmaceutical, which is developing SBP gel with Brickell Biotech. Dr. Abels is an employee of the company that is developing GPB cream.

[email protected]

The American Society of Clinical Oncology “does not generally support” at-home infusions of anticancer therapy because of safety concerns, the organization says in a new policy statement issued July 31.

At the same time, it supports exceptions: namely, when individual physicians and patients, having jointly discussed risks and benefits, agree to have treatments administered in the home.

The new policy is limited to intravenous infusions of anticancer agents such as chemotherapy, monoclonal antibodies, and other drugs — administered by health care personnel. It does not refer to injections.

The policy was prompted by regulatory flexibilities from the Centers for Medicare & Medicaid Services made in response to the accelerating COVID-19 pandemic. “Among these flexibilities were new provisions that enabled providers to deliver care in a setting most appropriate – and safest – for individual patient circumstances,” which has “opened the path for potential increases in use of home infusion for anticancer therapy,” says ASCO.

“We’re not ready to endorse [chemo at home] as a general policy until we have evidence that it’s safe. At the same time, the policy gives physicians and patients autonomy to respond to whatever situation they find themselves in,” Stephen Grubbs, MD, ASCO’s senior director of clinical affairs, said in an interview.

“Antineoplastic drugs are effective at treating cancer but can be extremely toxic to normal human cells,” reads the statement, which was written by a group of about 25 professionals, including Grubbs and other ASCO staff as well as independent advisers.

“There is a paucity of evidence directly comparing the safety of chemotherapy infusions in the home and outpatient settings,” the ASCO policy explains.

ASCO’s policy acknowledges that there are data “from other countries demonstrating that ... home infusion can be safe, well-tolerated, and may be preferred by some patients.” But such data are limited and only apply “to certain circumstances and for specific agents,” it adds.

One US cancer center (in Philadelphia) already has an established chemo-at-home program and has seen an increase in its use during the pandemic, as reported by Medscape Medical News. Approached for comment, Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation in Philadelphia, interpreted the new ASCO policy in a positive light.

“Physicians at the Abramson Cancer Center of the University of Pennsylvania and ASCO agree – home-based cancer therapy with oncologist oversight and well-designed safety protocols can be a safe option for patients with cancer,” he said in a statement.

ASCO says its existing safety standards “may be difficult to satisfy in the home infusion context,” including for safely resolving life-threatening emergencies.

Grubbs said that in the worst-case scenario, such as anaphylaxis, “you can die from [it] if you don’t manage it quickly and properly.”

“When I was practicing, we always had a physician present right next to the infusion area because these are severe reactions that happen very quickly,” he said, adding that “several a year” occurred when he practiced full-time.

Also, chemotherapy spills are a “big deal” in the home, as clean-up may be complex and difficult, added Grubbs.

Data from ASCO’s PracticeNET program show that in the first months (March and April) of the COVID-19 pandemic, chemotherapy visits to infusion suites were not reduced in a dataset of 16 US practices, he noted. However, there are exceptions and variance based on location, Grubbs said, such as “hot spots” including New York City in April.

While the pandemic has no end in sight, ASCO issued a set of six recommendations for use of anticancer therapies infused in the home. First, they call for independent, publicly funded research to evaluate the safety and effectiveness of home infusion of anticancer therapy.

Next in importance, ASCO wants the current temporary regulation change from CMS due to the pandemic to end.

“CMS should not extend the temporary flexibility related to home infusion for Part B cancer drugs that was approved as part of their response to the public health emergency,” they state.

Even before the pandemic, changes were afoot. Under the 21st Century Cures Act, which was passed in 2019 and will be implemented in 2021, CMS instituted a permanent home infusion therapy services benefit, which includes anticancer therapies. It “remains to be seen what, if any, shift away from outpatient infusion facilities will occur,” observes ASCO in its policy statement.

This article first appeared on Medscape.com.

The American Society of Clinical Oncology “does not generally support” at-home infusions of anticancer therapy because of safety concerns, the organization says in a new policy statement issued July 31.

At the same time, it supports exceptions: namely, when individual physicians and patients, having jointly discussed risks and benefits, agree to have treatments administered in the home.

The new policy is limited to intravenous infusions of anticancer agents such as chemotherapy, monoclonal antibodies, and other drugs — administered by health care personnel. It does not refer to injections.

The policy was prompted by regulatory flexibilities from the Centers for Medicare & Medicaid Services made in response to the accelerating COVID-19 pandemic. “Among these flexibilities were new provisions that enabled providers to deliver care in a setting most appropriate – and safest – for individual patient circumstances,” which has “opened the path for potential increases in use of home infusion for anticancer therapy,” says ASCO.

“We’re not ready to endorse [chemo at home] as a general policy until we have evidence that it’s safe. At the same time, the policy gives physicians and patients autonomy to respond to whatever situation they find themselves in,” Stephen Grubbs, MD, ASCO’s senior director of clinical affairs, said in an interview.

“Antineoplastic drugs are effective at treating cancer but can be extremely toxic to normal human cells,” reads the statement, which was written by a group of about 25 professionals, including Grubbs and other ASCO staff as well as independent advisers.

“There is a paucity of evidence directly comparing the safety of chemotherapy infusions in the home and outpatient settings,” the ASCO policy explains.

ASCO’s policy acknowledges that there are data “from other countries demonstrating that ... home infusion can be safe, well-tolerated, and may be preferred by some patients.” But such data are limited and only apply “to certain circumstances and for specific agents,” it adds.

One US cancer center (in Philadelphia) already has an established chemo-at-home program and has seen an increase in its use during the pandemic, as reported by Medscape Medical News. Approached for comment, Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation in Philadelphia, interpreted the new ASCO policy in a positive light.

“Physicians at the Abramson Cancer Center of the University of Pennsylvania and ASCO agree – home-based cancer therapy with oncologist oversight and well-designed safety protocols can be a safe option for patients with cancer,” he said in a statement.

ASCO says its existing safety standards “may be difficult to satisfy in the home infusion context,” including for safely resolving life-threatening emergencies.

Grubbs said that in the worst-case scenario, such as anaphylaxis, “you can die from [it] if you don’t manage it quickly and properly.”

“When I was practicing, we always had a physician present right next to the infusion area because these are severe reactions that happen very quickly,” he said, adding that “several a year” occurred when he practiced full-time.

Also, chemotherapy spills are a “big deal” in the home, as clean-up may be complex and difficult, added Grubbs.

Data from ASCO’s PracticeNET program show that in the first months (March and April) of the COVID-19 pandemic, chemotherapy visits to infusion suites were not reduced in a dataset of 16 US practices, he noted. However, there are exceptions and variance based on location, Grubbs said, such as “hot spots” including New York City in April.

While the pandemic has no end in sight, ASCO issued a set of six recommendations for use of anticancer therapies infused in the home. First, they call for independent, publicly funded research to evaluate the safety and effectiveness of home infusion of anticancer therapy.

Next in importance, ASCO wants the current temporary regulation change from CMS due to the pandemic to end.

“CMS should not extend the temporary flexibility related to home infusion for Part B cancer drugs that was approved as part of their response to the public health emergency,” they state.

Even before the pandemic, changes were afoot. Under the 21st Century Cures Act, which was passed in 2019 and will be implemented in 2021, CMS instituted a permanent home infusion therapy services benefit, which includes anticancer therapies. It “remains to be seen what, if any, shift away from outpatient infusion facilities will occur,” observes ASCO in its policy statement.

This article first appeared on Medscape.com.

The American Society of Clinical Oncology “does not generally support” at-home infusions of anticancer therapy because of safety concerns, the organization says in a new policy statement issued July 31.

At the same time, it supports exceptions: namely, when individual physicians and patients, having jointly discussed risks and benefits, agree to have treatments administered in the home.

The new policy is limited to intravenous infusions of anticancer agents such as chemotherapy, monoclonal antibodies, and other drugs — administered by health care personnel. It does not refer to injections.

The policy was prompted by regulatory flexibilities from the Centers for Medicare & Medicaid Services made in response to the accelerating COVID-19 pandemic. “Among these flexibilities were new provisions that enabled providers to deliver care in a setting most appropriate – and safest – for individual patient circumstances,” which has “opened the path for potential increases in use of home infusion for anticancer therapy,” says ASCO.

“We’re not ready to endorse [chemo at home] as a general policy until we have evidence that it’s safe. At the same time, the policy gives physicians and patients autonomy to respond to whatever situation they find themselves in,” Stephen Grubbs, MD, ASCO’s senior director of clinical affairs, said in an interview.

“Antineoplastic drugs are effective at treating cancer but can be extremely toxic to normal human cells,” reads the statement, which was written by a group of about 25 professionals, including Grubbs and other ASCO staff as well as independent advisers.

“There is a paucity of evidence directly comparing the safety of chemotherapy infusions in the home and outpatient settings,” the ASCO policy explains.

ASCO’s policy acknowledges that there are data “from other countries demonstrating that ... home infusion can be safe, well-tolerated, and may be preferred by some patients.” But such data are limited and only apply “to certain circumstances and for specific agents,” it adds.

One US cancer center (in Philadelphia) already has an established chemo-at-home program and has seen an increase in its use during the pandemic, as reported by Medscape Medical News. Approached for comment, Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation in Philadelphia, interpreted the new ASCO policy in a positive light.

“Physicians at the Abramson Cancer Center of the University of Pennsylvania and ASCO agree – home-based cancer therapy with oncologist oversight and well-designed safety protocols can be a safe option for patients with cancer,” he said in a statement.

ASCO says its existing safety standards “may be difficult to satisfy in the home infusion context,” including for safely resolving life-threatening emergencies.

Grubbs said that in the worst-case scenario, such as anaphylaxis, “you can die from [it] if you don’t manage it quickly and properly.”

“When I was practicing, we always had a physician present right next to the infusion area because these are severe reactions that happen very quickly,” he said, adding that “several a year” occurred when he practiced full-time.

Also, chemotherapy spills are a “big deal” in the home, as clean-up may be complex and difficult, added Grubbs.

Data from ASCO’s PracticeNET program show that in the first months (March and April) of the COVID-19 pandemic, chemotherapy visits to infusion suites were not reduced in a dataset of 16 US practices, he noted. However, there are exceptions and variance based on location, Grubbs said, such as “hot spots” including New York City in April.

While the pandemic has no end in sight, ASCO issued a set of six recommendations for use of anticancer therapies infused in the home. First, they call for independent, publicly funded research to evaluate the safety and effectiveness of home infusion of anticancer therapy.

Next in importance, ASCO wants the current temporary regulation change from CMS due to the pandemic to end.

“CMS should not extend the temporary flexibility related to home infusion for Part B cancer drugs that was approved as part of their response to the public health emergency,” they state.

Even before the pandemic, changes were afoot. Under the 21st Century Cures Act, which was passed in 2019 and will be implemented in 2021, CMS instituted a permanent home infusion therapy services benefit, which includes anticancer therapies. It “remains to be seen what, if any, shift away from outpatient infusion facilities will occur,” observes ASCO in its policy statement.

This article first appeared on Medscape.com.

When Virginia’s governor directed the postponement of all elective surgeries in late March, Wayne Batchelor, MD and his colleagues at the Inova Heart and Vascular Institute in Falls Church, Va., canceled about two-thirds of their transcatheter aortic valve replacement (TAVR) procedures.

Courtesy Wayne Batchelor, MD

They then categorized patients by tiers to gauge which procedures could safely be postponed and to guide triaging. And while they did not deviate from the practice of having both an interventional cardiologist and a cardiothoracic surgeon present for TAVR, they slimmed down preprocedural testing when feasible and delayed some 30-day post-TAVR echocardiographic assessments. “It was a delicate dance, very difficult dance. But luckily, we were able to navigate the challenges effectively,” said Dr. Batchelor, the institute’s director of interventional cardiology and interventional cardiology research.

A “system capacity dashboard” that merged bed and staffing data from interventional cardiology spaces with cardiovascular and noncardiovascular ICU beds, operating rooms, and other resources – and daily cross-department meetings – enabled them to proceed with the most urgent TAVR procedures while “keeping a buffer of ICU beds to accommodate an anticipated surge of COVID-19,” he explained.

Such adaptations in cardiac procedures and processes are occurring in hospitals across the country as efforts are made to minimize the risk of COVID-19 exposure for patients and staff. Dr. Batchelor is one of four cardiologists who shared their experiences and advice on common cardiac procedures across three locales: TAVR in Virginia, percutaneous coronary intervention (PCI) in New York City, and atrial fibrillation (AFib) ablation in Kentucky.
 

More on TAVR in Virginia

Inova’s framework for triaging structural heart disease interventions (largely TAVR and/or percutaneous mitral valve repair) comprised three tiers. Tier 1 captured “emergent cases that had to be done, no questions asked,” Dr. Batchelor said. For TAVR, these were inpatients with severe to critical symptomatic aortic stenosis and advanced congestive heart failure who could not safely be discharged, as well as other patients “with refractory symptoms of heart failure that were compelling.” Many had associated left ventricular systolic dysfunction.

Those who could delay 14-30 days were placed in tier 2, and patients who “we felt were fairly stable and could wait at least 30 days” were placed in tier 3. “For TAVR, a tier 3 patient might be the one … who has severe aortic stenosis but is walking around and doing well at home with only stable exertional symptoms,” he said.

Patients whose procedures were delayed were contacted weekly by the valve clinic’s advanced practice practitioners through video visits or telephone calls, and tier categorization was reevaluated if symptoms worsened. “We had to keep in close contact with them,” Dr. Batchelor said. “These patients can deteriorate quite rapidly and sometimes without much warning.”

Virtual video visits were often used for 30-day postprocedural follow-ups, taking the place of in-person visits during which post-TAVR echocardiographic assessments would normally be performed. “For follow-up, we’d often just do a quick visit to check the vascular access site within 7-10 days, and then, if they were doing okay we’d delay the 30-day echo to a later time frame,” he said.

Preprocedural testing was streamlined to minimize the number of patient-provider interactions, with pulmonary function testing and pre-TAVR catheterization omitted unless absolutely necessary. “A TAVR CT angiogram [performed within the prior year] is the only test you really absolutely need,” Dr. Batchelor said. “We were much less likely to order a heart catheterization unless the patient was having angina and high risk or suspicion for significant coronary artery disease.”

This approach was not associated with any compromise in postprocedural outcomes, he noted. Prior to the pandemic, Inova routinely employed a minimalist approach to TAVR with moderate conscious sedation and avoiding transesophageal echocardiography – steps that were recommended for structural heart procedures in the COVID-19 era in a published review by the heart team at New York-Presbyterian Hospital/Columbia University Irving Medical Center.

The New York review is useful for cardiologists in areas with rising case burdens of COVID-19, Dr. Batchelor said, as is a position statement he coauthored from the American College of Cardiology and the Society for Cardiology and Angiography Interventions (SCAI) on triage considerations for structural heart disease interventions during the pandemic.

TAVR’s resource-heavy nature made the “system capacity dashboard” and daily meetings critical, Dr. Batchelor explained. At one point during the hold on elective procedures, the Falls Church INOVA facility had approximately 300 patients with COVID-19, a significant proportion of whom were in cardiac ICU beds.

“Everyone has to be flexible and learn,” he said. “We trained our cardiologists on managing ventilators in case some of the [critical care] staff got ill or were overwhelmed by the surge.”

More than 2 months after the surge eased and the ban on elective surgery was lifted, Dr. Batchelor and his colleagues are still using the dashboard and continue to meet daily to discuss COVID-19 prevalence in the hospital and the community as they work through the backlog of delayed procedures. They also routinely review the status of COVID-19 testing for inpatients and outpatients and the donning and doffing of personal protective equipment.

“You have to communicate early and often across the whole system of care because you’re competing for the same resources,” he advised. “And you have to be flexible and reassess. A policy that works at the beginning of the pandemic might have to change.”
 

PCI in New York

Before the pandemic, the cardiac catheterization laboratory at Mount Sinai Morningside Hospital in New York handled a monthly average of 140-150 PCIs, including 6-10 primary PCIs for ST-segment elevation myocardial infarction.

Courtesy of Mount Sinai Morningside

When electives were halted by the hospital in March and the City became the global epicenter for COVID-19, the cath lab went quiet. “Even though we were still able to do urgent cases or emergent cases, the case volume dropped tremendously,” said Jacqueline E. Tamis-Holland, MD, associate director of the cardiac catheterization laboratory and director of the interventional cardiology fellowship. “There weren’t many outpatients in our hospital … and by late March and through April, there wasn’t a single acute infarction.”

She and Tak W. Kwan, MD, director of the cardiac catheterization laboratory and professor of medicine at Icahn School of Medicine at Mount Sinai, New York, were prepared to move true STEMI patients into the cath lab for primary PCI without delay unless the staff or system were overrun.

That primary PCI should remain the first-line treatment for STEMI even in cases of confirmed or suspected COVID-19 was recommended by SCAI guidance issued in March and by a consensus statement released by the SCAI, ACC, and American College of Emergency Physicians in April – and “we were very much of the same frame of mind,” Dr. Tamis-Holland said.

Deciding which elective cases could not be delayed required a completely individualized approach, the cardiologists emphasized. Dr. Tamis-Holland had a few patients scheduled for elective PCI when the hold began, and “we spoke every few days or once a week in the beginning, then transitioned to once every 2 weeks,” she said. “With medical therapy and given that they were relatively sedentary, my patients did okay [with the delays].”

For subsequent patients, she considered their symptoms or stress test results. “If it’s someone who I’d [normally] wait until next week to schedule the cath, then we would wait 2 or 3 more weeks, or a month more with careful monitoring,” she said. “Certainly, there was a decrease in the number of abnormal stress tests that I referred to the cath lab during [the surge period].”

Dr. Kwan described one patient who had new-onset congestive heart failure in late March “with a markedly positive nuclear stress test.” The patient was monitored with twice-weekly telemedicine visits and office visits, and a cardiac catheterization was performed in early May as an urgent elective case. “He had severe three-vessel and left main disease,” he said. “Subsequently, [coronary artery bypass surgery] was done.”

There were no changes in the PCI procedure itself in terms of hospital stay (most elective cases at Mt. Sinai are same-day procedures) or in staffing, other than a ban on visiting students or residents. The most important changes during the surge – in addition to stocking enough personal protective equipment – concerned testing. Patients undergoing elective PCI are tested for the novel coronavirus 72 hours before the procedure, and rapid testing is performed in the emergency room for STEMI patients to determine patient disposition after the procedure.

“Until we have the results back we should treat all patients as if they are a patient under investigation or have COVID,” said Dr. Tamis-Holland, who helped develop emergency guidance on STEMI systems of care during the pandemic for the American Heart Association.

In early May, the hospital freed up additional space for cardiac care, allowing more “urgent-elective” PCIs to be done. Some patients were reluctant to proceed, the cardiologists said, because of a no-visitor policy. In mid-June, the hold on elective procedures was lifted, and around the same time, the hospital shifted to a one-visitor policy. Still, some patients opted to continue longer with medical therapy.

Patients need to feel comfortable, and “there is a lag time from the time everything opens up and when patients get their stress tests and their evaluations, and then arrive for PCI,” said Dr. Tamis-Holland.

By mid-July, the cardiologists were anticipating an increase in complications from infarctions among patients who “waited them out at home” – heart failure or mitral valve regurgitation, for instance – but, in their hospital at least, “we haven’t really seen that,” she added.
 

AFib ablation in Kentucky

As New York experienced its surge, John Mandrola, MD, and other electrophysiologists across the Baptist Health system in Kentucky reached a consensus on how to categorize their procedures. Electrophysiology interventions were classified urgent, emergent, and truly elective in the event that the state’s relatively low case burden of COVID-19 were to significantly worsen.

There was no doubt where AFib ablation sat. “It’s one of the most elective procedures there is” in terms of scheduling under normal circumstances, and it almost always requires an overnight stay and general anesthesia – factors that upped the ante on an elective classification, said Dr. Mandrola.

All AF ablations were deemed elective unless the patient required immediate hospitalization. For 8-10 weeks during the state’s shutdown of elective care, Dr. Mandrola and his partner successfully monitored patients with phone calls. “To be honest,” he said, “most patients did not want to have their AFib ablation anyway until the pandemic slowed and they knew it was safe.”

In some cases, patients reported that their symptoms were improving: “There are so many things to speculate about. ... Was it that everyone took their foot off the accelerator?” Dr. Mandrola thinks that postpandemic outcomes analyses may drive more scrutiny of the necessity of some AFib ablations and other procedures and tests. AFib ablation “has its place but is probably overused,” he said.

During the pause on electives, “the vast majority of procedures we did were pacemaker procedures,” he said. “We also did some atrial flutter ablations, and ablations for ventricular tachycardia and supraventricular tachycardia.” In mid-July, as the COVID-19 case burden in Kentucky remained relatively low, Dr. Mandrola was “up to 120%” of his pre-COVID electrophysiology volume – but ready to scale back again if needed.

Dr. Batchelor reported consulting fees from Boston Scientific, Abbott Medical, Medtronic, and V-wave. Dr. Kwan, Dr. Mandrola, and Dr. Tamis-Holland reported no relevant financial disclosures.
 

This article is a collaboration between Medscape and MDedge. A version of it originally appeared on Medscape.com.

When Virginia’s governor directed the postponement of all elective surgeries in late March, Wayne Batchelor, MD and his colleagues at the Inova Heart and Vascular Institute in Falls Church, Va., canceled about two-thirds of their transcatheter aortic valve replacement (TAVR) procedures.

Courtesy Wayne Batchelor, MD

They then categorized patients by tiers to gauge which procedures could safely be postponed and to guide triaging. And while they did not deviate from the practice of having both an interventional cardiologist and a cardiothoracic surgeon present for TAVR, they slimmed down preprocedural testing when feasible and delayed some 30-day post-TAVR echocardiographic assessments. “It was a delicate dance, very difficult dance. But luckily, we were able to navigate the challenges effectively,” said Dr. Batchelor, the institute’s director of interventional cardiology and interventional cardiology research.

A “system capacity dashboard” that merged bed and staffing data from interventional cardiology spaces with cardiovascular and noncardiovascular ICU beds, operating rooms, and other resources – and daily cross-department meetings – enabled them to proceed with the most urgent TAVR procedures while “keeping a buffer of ICU beds to accommodate an anticipated surge of COVID-19,” he explained.

Such adaptations in cardiac procedures and processes are occurring in hospitals across the country as efforts are made to minimize the risk of COVID-19 exposure for patients and staff. Dr. Batchelor is one of four cardiologists who shared their experiences and advice on common cardiac procedures across three locales: TAVR in Virginia, percutaneous coronary intervention (PCI) in New York City, and atrial fibrillation (AFib) ablation in Kentucky.
 

More on TAVR in Virginia

Inova’s framework for triaging structural heart disease interventions (largely TAVR and/or percutaneous mitral valve repair) comprised three tiers. Tier 1 captured “emergent cases that had to be done, no questions asked,” Dr. Batchelor said. For TAVR, these were inpatients with severe to critical symptomatic aortic stenosis and advanced congestive heart failure who could not safely be discharged, as well as other patients “with refractory symptoms of heart failure that were compelling.” Many had associated left ventricular systolic dysfunction.

Those who could delay 14-30 days were placed in tier 2, and patients who “we felt were fairly stable and could wait at least 30 days” were placed in tier 3. “For TAVR, a tier 3 patient might be the one … who has severe aortic stenosis but is walking around and doing well at home with only stable exertional symptoms,” he said.

Patients whose procedures were delayed were contacted weekly by the valve clinic’s advanced practice practitioners through video visits or telephone calls, and tier categorization was reevaluated if symptoms worsened. “We had to keep in close contact with them,” Dr. Batchelor said. “These patients can deteriorate quite rapidly and sometimes without much warning.”

Virtual video visits were often used for 30-day postprocedural follow-ups, taking the place of in-person visits during which post-TAVR echocardiographic assessments would normally be performed. “For follow-up, we’d often just do a quick visit to check the vascular access site within 7-10 days, and then, if they were doing okay we’d delay the 30-day echo to a later time frame,” he said.

Preprocedural testing was streamlined to minimize the number of patient-provider interactions, with pulmonary function testing and pre-TAVR catheterization omitted unless absolutely necessary. “A TAVR CT angiogram [performed within the prior year] is the only test you really absolutely need,” Dr. Batchelor said. “We were much less likely to order a heart catheterization unless the patient was having angina and high risk or suspicion for significant coronary artery disease.”

This approach was not associated with any compromise in postprocedural outcomes, he noted. Prior to the pandemic, Inova routinely employed a minimalist approach to TAVR with moderate conscious sedation and avoiding transesophageal echocardiography – steps that were recommended for structural heart procedures in the COVID-19 era in a published review by the heart team at New York-Presbyterian Hospital/Columbia University Irving Medical Center.

The New York review is useful for cardiologists in areas with rising case burdens of COVID-19, Dr. Batchelor said, as is a position statement he coauthored from the American College of Cardiology and the Society for Cardiology and Angiography Interventions (SCAI) on triage considerations for structural heart disease interventions during the pandemic.

TAVR’s resource-heavy nature made the “system capacity dashboard” and daily meetings critical, Dr. Batchelor explained. At one point during the hold on elective procedures, the Falls Church INOVA facility had approximately 300 patients with COVID-19, a significant proportion of whom were in cardiac ICU beds.

“Everyone has to be flexible and learn,” he said. “We trained our cardiologists on managing ventilators in case some of the [critical care] staff got ill or were overwhelmed by the surge.”

More than 2 months after the surge eased and the ban on elective surgery was lifted, Dr. Batchelor and his colleagues are still using the dashboard and continue to meet daily to discuss COVID-19 prevalence in the hospital and the community as they work through the backlog of delayed procedures. They also routinely review the status of COVID-19 testing for inpatients and outpatients and the donning and doffing of personal protective equipment.

“You have to communicate early and often across the whole system of care because you’re competing for the same resources,” he advised. “And you have to be flexible and reassess. A policy that works at the beginning of the pandemic might have to change.”
 

PCI in New York

Before the pandemic, the cardiac catheterization laboratory at Mount Sinai Morningside Hospital in New York handled a monthly average of 140-150 PCIs, including 6-10 primary PCIs for ST-segment elevation myocardial infarction.

Courtesy of Mount Sinai Morningside

When electives were halted by the hospital in March and the City became the global epicenter for COVID-19, the cath lab went quiet. “Even though we were still able to do urgent cases or emergent cases, the case volume dropped tremendously,” said Jacqueline E. Tamis-Holland, MD, associate director of the cardiac catheterization laboratory and director of the interventional cardiology fellowship. “There weren’t many outpatients in our hospital … and by late March and through April, there wasn’t a single acute infarction.”

She and Tak W. Kwan, MD, director of the cardiac catheterization laboratory and professor of medicine at Icahn School of Medicine at Mount Sinai, New York, were prepared to move true STEMI patients into the cath lab for primary PCI without delay unless the staff or system were overrun.

That primary PCI should remain the first-line treatment for STEMI even in cases of confirmed or suspected COVID-19 was recommended by SCAI guidance issued in March and by a consensus statement released by the SCAI, ACC, and American College of Emergency Physicians in April – and “we were very much of the same frame of mind,” Dr. Tamis-Holland said.

Deciding which elective cases could not be delayed required a completely individualized approach, the cardiologists emphasized. Dr. Tamis-Holland had a few patients scheduled for elective PCI when the hold began, and “we spoke every few days or once a week in the beginning, then transitioned to once every 2 weeks,” she said. “With medical therapy and given that they were relatively sedentary, my patients did okay [with the delays].”

For subsequent patients, she considered their symptoms or stress test results. “If it’s someone who I’d [normally] wait until next week to schedule the cath, then we would wait 2 or 3 more weeks, or a month more with careful monitoring,” she said. “Certainly, there was a decrease in the number of abnormal stress tests that I referred to the cath lab during [the surge period].”

Dr. Kwan described one patient who had new-onset congestive heart failure in late March “with a markedly positive nuclear stress test.” The patient was monitored with twice-weekly telemedicine visits and office visits, and a cardiac catheterization was performed in early May as an urgent elective case. “He had severe three-vessel and left main disease,” he said. “Subsequently, [coronary artery bypass surgery] was done.”

There were no changes in the PCI procedure itself in terms of hospital stay (most elective cases at Mt. Sinai are same-day procedures) or in staffing, other than a ban on visiting students or residents. The most important changes during the surge – in addition to stocking enough personal protective equipment – concerned testing. Patients undergoing elective PCI are tested for the novel coronavirus 72 hours before the procedure, and rapid testing is performed in the emergency room for STEMI patients to determine patient disposition after the procedure.

“Until we have the results back we should treat all patients as if they are a patient under investigation or have COVID,” said Dr. Tamis-Holland, who helped develop emergency guidance on STEMI systems of care during the pandemic for the American Heart Association.

In early May, the hospital freed up additional space for cardiac care, allowing more “urgent-elective” PCIs to be done. Some patients were reluctant to proceed, the cardiologists said, because of a no-visitor policy. In mid-June, the hold on elective procedures was lifted, and around the same time, the hospital shifted to a one-visitor policy. Still, some patients opted to continue longer with medical therapy.

Patients need to feel comfortable, and “there is a lag time from the time everything opens up and when patients get their stress tests and their evaluations, and then arrive for PCI,” said Dr. Tamis-Holland.

By mid-July, the cardiologists were anticipating an increase in complications from infarctions among patients who “waited them out at home” – heart failure or mitral valve regurgitation, for instance – but, in their hospital at least, “we haven’t really seen that,” she added.
 

AFib ablation in Kentucky

As New York experienced its surge, John Mandrola, MD, and other electrophysiologists across the Baptist Health system in Kentucky reached a consensus on how to categorize their procedures. Electrophysiology interventions were classified urgent, emergent, and truly elective in the event that the state’s relatively low case burden of COVID-19 were to significantly worsen.

There was no doubt where AFib ablation sat. “It’s one of the most elective procedures there is” in terms of scheduling under normal circumstances, and it almost always requires an overnight stay and general anesthesia – factors that upped the ante on an elective classification, said Dr. Mandrola.

All AF ablations were deemed elective unless the patient required immediate hospitalization. For 8-10 weeks during the state’s shutdown of elective care, Dr. Mandrola and his partner successfully monitored patients with phone calls. “To be honest,” he said, “most patients did not want to have their AFib ablation anyway until the pandemic slowed and they knew it was safe.”

In some cases, patients reported that their symptoms were improving: “There are so many things to speculate about. ... Was it that everyone took their foot off the accelerator?” Dr. Mandrola thinks that postpandemic outcomes analyses may drive more scrutiny of the necessity of some AFib ablations and other procedures and tests. AFib ablation “has its place but is probably overused,” he said.

During the pause on electives, “the vast majority of procedures we did were pacemaker procedures,” he said. “We also did some atrial flutter ablations, and ablations for ventricular tachycardia and supraventricular tachycardia.” In mid-July, as the COVID-19 case burden in Kentucky remained relatively low, Dr. Mandrola was “up to 120%” of his pre-COVID electrophysiology volume – but ready to scale back again if needed.

Dr. Batchelor reported consulting fees from Boston Scientific, Abbott Medical, Medtronic, and V-wave. Dr. Kwan, Dr. Mandrola, and Dr. Tamis-Holland reported no relevant financial disclosures.
 

This article is a collaboration between Medscape and MDedge. A version of it originally appeared on Medscape.com.

When Virginia’s governor directed the postponement of all elective surgeries in late March, Wayne Batchelor, MD and his colleagues at the Inova Heart and Vascular Institute in Falls Church, Va., canceled about two-thirds of their transcatheter aortic valve replacement (TAVR) procedures.

Courtesy Wayne Batchelor, MD

They then categorized patients by tiers to gauge which procedures could safely be postponed and to guide triaging. And while they did not deviate from the practice of having both an interventional cardiologist and a cardiothoracic surgeon present for TAVR, they slimmed down preprocedural testing when feasible and delayed some 30-day post-TAVR echocardiographic assessments. “It was a delicate dance, very difficult dance. But luckily, we were able to navigate the challenges effectively,” said Dr. Batchelor, the institute’s director of interventional cardiology and interventional cardiology research.

A “system capacity dashboard” that merged bed and staffing data from interventional cardiology spaces with cardiovascular and noncardiovascular ICU beds, operating rooms, and other resources – and daily cross-department meetings – enabled them to proceed with the most urgent TAVR procedures while “keeping a buffer of ICU beds to accommodate an anticipated surge of COVID-19,” he explained.

Such adaptations in cardiac procedures and processes are occurring in hospitals across the country as efforts are made to minimize the risk of COVID-19 exposure for patients and staff. Dr. Batchelor is one of four cardiologists who shared their experiences and advice on common cardiac procedures across three locales: TAVR in Virginia, percutaneous coronary intervention (PCI) in New York City, and atrial fibrillation (AFib) ablation in Kentucky.
 

More on TAVR in Virginia

Inova’s framework for triaging structural heart disease interventions (largely TAVR and/or percutaneous mitral valve repair) comprised three tiers. Tier 1 captured “emergent cases that had to be done, no questions asked,” Dr. Batchelor said. For TAVR, these were inpatients with severe to critical symptomatic aortic stenosis and advanced congestive heart failure who could not safely be discharged, as well as other patients “with refractory symptoms of heart failure that were compelling.” Many had associated left ventricular systolic dysfunction.

Those who could delay 14-30 days were placed in tier 2, and patients who “we felt were fairly stable and could wait at least 30 days” were placed in tier 3. “For TAVR, a tier 3 patient might be the one … who has severe aortic stenosis but is walking around and doing well at home with only stable exertional symptoms,” he said.

Patients whose procedures were delayed were contacted weekly by the valve clinic’s advanced practice practitioners through video visits or telephone calls, and tier categorization was reevaluated if symptoms worsened. “We had to keep in close contact with them,” Dr. Batchelor said. “These patients can deteriorate quite rapidly and sometimes without much warning.”

Virtual video visits were often used for 30-day postprocedural follow-ups, taking the place of in-person visits during which post-TAVR echocardiographic assessments would normally be performed. “For follow-up, we’d often just do a quick visit to check the vascular access site within 7-10 days, and then, if they were doing okay we’d delay the 30-day echo to a later time frame,” he said.

Preprocedural testing was streamlined to minimize the number of patient-provider interactions, with pulmonary function testing and pre-TAVR catheterization omitted unless absolutely necessary. “A TAVR CT angiogram [performed within the prior year] is the only test you really absolutely need,” Dr. Batchelor said. “We were much less likely to order a heart catheterization unless the patient was having angina and high risk or suspicion for significant coronary artery disease.”

This approach was not associated with any compromise in postprocedural outcomes, he noted. Prior to the pandemic, Inova routinely employed a minimalist approach to TAVR with moderate conscious sedation and avoiding transesophageal echocardiography – steps that were recommended for structural heart procedures in the COVID-19 era in a published review by the heart team at New York-Presbyterian Hospital/Columbia University Irving Medical Center.

The New York review is useful for cardiologists in areas with rising case burdens of COVID-19, Dr. Batchelor said, as is a position statement he coauthored from the American College of Cardiology and the Society for Cardiology and Angiography Interventions (SCAI) on triage considerations for structural heart disease interventions during the pandemic.

TAVR’s resource-heavy nature made the “system capacity dashboard” and daily meetings critical, Dr. Batchelor explained. At one point during the hold on elective procedures, the Falls Church INOVA facility had approximately 300 patients with COVID-19, a significant proportion of whom were in cardiac ICU beds.

“Everyone has to be flexible and learn,” he said. “We trained our cardiologists on managing ventilators in case some of the [critical care] staff got ill or were overwhelmed by the surge.”

More than 2 months after the surge eased and the ban on elective surgery was lifted, Dr. Batchelor and his colleagues are still using the dashboard and continue to meet daily to discuss COVID-19 prevalence in the hospital and the community as they work through the backlog of delayed procedures. They also routinely review the status of COVID-19 testing for inpatients and outpatients and the donning and doffing of personal protective equipment.

“You have to communicate early and often across the whole system of care because you’re competing for the same resources,” he advised. “And you have to be flexible and reassess. A policy that works at the beginning of the pandemic might have to change.”
 

PCI in New York

Before the pandemic, the cardiac catheterization laboratory at Mount Sinai Morningside Hospital in New York handled a monthly average of 140-150 PCIs, including 6-10 primary PCIs for ST-segment elevation myocardial infarction.

Courtesy of Mount Sinai Morningside

When electives were halted by the hospital in March and the City became the global epicenter for COVID-19, the cath lab went quiet. “Even though we were still able to do urgent cases or emergent cases, the case volume dropped tremendously,” said Jacqueline E. Tamis-Holland, MD, associate director of the cardiac catheterization laboratory and director of the interventional cardiology fellowship. “There weren’t many outpatients in our hospital … and by late March and through April, there wasn’t a single acute infarction.”

She and Tak W. Kwan, MD, director of the cardiac catheterization laboratory and professor of medicine at Icahn School of Medicine at Mount Sinai, New York, were prepared to move true STEMI patients into the cath lab for primary PCI without delay unless the staff or system were overrun.

That primary PCI should remain the first-line treatment for STEMI even in cases of confirmed or suspected COVID-19 was recommended by SCAI guidance issued in March and by a consensus statement released by the SCAI, ACC, and American College of Emergency Physicians in April – and “we were very much of the same frame of mind,” Dr. Tamis-Holland said.

Deciding which elective cases could not be delayed required a completely individualized approach, the cardiologists emphasized. Dr. Tamis-Holland had a few patients scheduled for elective PCI when the hold began, and “we spoke every few days or once a week in the beginning, then transitioned to once every 2 weeks,” she said. “With medical therapy and given that they were relatively sedentary, my patients did okay [with the delays].”

For subsequent patients, she considered their symptoms or stress test results. “If it’s someone who I’d [normally] wait until next week to schedule the cath, then we would wait 2 or 3 more weeks, or a month more with careful monitoring,” she said. “Certainly, there was a decrease in the number of abnormal stress tests that I referred to the cath lab during [the surge period].”

Dr. Kwan described one patient who had new-onset congestive heart failure in late March “with a markedly positive nuclear stress test.” The patient was monitored with twice-weekly telemedicine visits and office visits, and a cardiac catheterization was performed in early May as an urgent elective case. “He had severe three-vessel and left main disease,” he said. “Subsequently, [coronary artery bypass surgery] was done.”

There were no changes in the PCI procedure itself in terms of hospital stay (most elective cases at Mt. Sinai are same-day procedures) or in staffing, other than a ban on visiting students or residents. The most important changes during the surge – in addition to stocking enough personal protective equipment – concerned testing. Patients undergoing elective PCI are tested for the novel coronavirus 72 hours before the procedure, and rapid testing is performed in the emergency room for STEMI patients to determine patient disposition after the procedure.

“Until we have the results back we should treat all patients as if they are a patient under investigation or have COVID,” said Dr. Tamis-Holland, who helped develop emergency guidance on STEMI systems of care during the pandemic for the American Heart Association.

In early May, the hospital freed up additional space for cardiac care, allowing more “urgent-elective” PCIs to be done. Some patients were reluctant to proceed, the cardiologists said, because of a no-visitor policy. In mid-June, the hold on elective procedures was lifted, and around the same time, the hospital shifted to a one-visitor policy. Still, some patients opted to continue longer with medical therapy.

Patients need to feel comfortable, and “there is a lag time from the time everything opens up and when patients get their stress tests and their evaluations, and then arrive for PCI,” said Dr. Tamis-Holland.

By mid-July, the cardiologists were anticipating an increase in complications from infarctions among patients who “waited them out at home” – heart failure or mitral valve regurgitation, for instance – but, in their hospital at least, “we haven’t really seen that,” she added.
 

AFib ablation in Kentucky

As New York experienced its surge, John Mandrola, MD, and other electrophysiologists across the Baptist Health system in Kentucky reached a consensus on how to categorize their procedures. Electrophysiology interventions were classified urgent, emergent, and truly elective in the event that the state’s relatively low case burden of COVID-19 were to significantly worsen.

There was no doubt where AFib ablation sat. “It’s one of the most elective procedures there is” in terms of scheduling under normal circumstances, and it almost always requires an overnight stay and general anesthesia – factors that upped the ante on an elective classification, said Dr. Mandrola.

All AF ablations were deemed elective unless the patient required immediate hospitalization. For 8-10 weeks during the state’s shutdown of elective care, Dr. Mandrola and his partner successfully monitored patients with phone calls. “To be honest,” he said, “most patients did not want to have their AFib ablation anyway until the pandemic slowed and they knew it was safe.”

In some cases, patients reported that their symptoms were improving: “There are so many things to speculate about. ... Was it that everyone took their foot off the accelerator?” Dr. Mandrola thinks that postpandemic outcomes analyses may drive more scrutiny of the necessity of some AFib ablations and other procedures and tests. AFib ablation “has its place but is probably overused,” he said.

During the pause on electives, “the vast majority of procedures we did were pacemaker procedures,” he said. “We also did some atrial flutter ablations, and ablations for ventricular tachycardia and supraventricular tachycardia.” In mid-July, as the COVID-19 case burden in Kentucky remained relatively low, Dr. Mandrola was “up to 120%” of his pre-COVID electrophysiology volume – but ready to scale back again if needed.

Dr. Batchelor reported consulting fees from Boston Scientific, Abbott Medical, Medtronic, and V-wave. Dr. Kwan, Dr. Mandrola, and Dr. Tamis-Holland reported no relevant financial disclosures.
 

This article is a collaboration between Medscape and MDedge. A version of it originally appeared on Medscape.com.

The American Cancer Society (ACS) has released updated guidelines for cervical cancer screening. The key recommendation is that primary human papillomavirus (HPV) testing is the preferred screening method, starting at the age of 25 and repeated every 5 years.

In the past, guidelines for cervical cancer screening recommended cytology (the Pap test) starting at 21 years of age and repeated every 3 years. In more recent years, cotesting (with both Pap and HPV tests) has been recommended.

Since the last ACS guidelines on cervical cancer screening were published in 2012, two HPV tests have been approved by the Food and Drug Administration (FDA) for use in primary HPV screening.

The new “streamlined recommendations can improve compliance and reduce potential harms,” commented Debbie Saslow, PhD, managing director, HPV/GYN Cancers, American Cancer Society.

The updated guidelines were published online July 30 in CA: A Cancer Journal for Clinicians.

“We now have stronger evidence to support starting cervical cancer screening at a later age and to recommend screening with the HPV test as the preferred test,” Saslow told Medscape Medical News. This also reflects the phasing out of cytology and cotesting, she added.

“This update is based on decades of studies comparing the effectiveness of HPV testing to cytology and is bolstered by evidence of the impact of HPV vaccination, including a dramatic decline in cervical precancers and, more recently, cervical cancers among young women,” she said.

The American Society for Colposcopy and Cervical Pathology (ASCCP) said that it was preparing a response to these new guidelines, as is the American College of Obstetricians and Gynecologists (ACOG).
 

Cotesting or cytology alone

The updated guidelines recommend primary HPV testing as the preferred screening method for all women with a cervix. If primary HPV testing is not available, women should be screened with cotesting, which should also be performed every 5 years.

If only cytology is available, then women should be screened every 3 years.

The ACS authors point out that cotesting or cytology testing alone is still an acceptable option for cervical cancer screening, insofar as primary HPV testing using FDA-approved tests may not be available in some settings.

As more laboratories in the United States transition to FDA-approved tests for primary HPV testing, it is expected that the use of cotesting or cytology alone will be phased out.

The new guidelines also emphasize that women may discontinue screening at the age of 65 if they have not had cervical intraepitheal neoplasia of grade 2 or higher within the past 25 years and if they have tested negative over the past 10 years on all past screens.

The authors caution that past screens should only be considered negative if the patient has had two consecutive negative HPV tests or two consecutive negative cotests or three consecutive negative cytology tests within the past 10 years.

“These criteria do not apply to individuals who are currently under surveillance for abnormal screening results,” the authors state.

Women older than 65 for whom adequate documentation of prior screening is not available should continue to be screened until criteria for screening discontinuation are met, they add.

Screening may be discontinued among women with a limited life expectancy.
 

HPV vaccination

The authors note that HPV vaccination is expected to substantially change cervical cancer screening strategies.

In 2018, the National Immunization Survey–Teen, involving adolescents aged 13 to 17 years, showed that 68.1% of female patients were up to date on HPV vaccine recommendations, as were 51.1% of male patients.

“Cytology-based screening is much less efficient in vaccinated populations, as abnormal cytology disproportionately identifies minor abnormalities resulting from HPV types that are associated with lower cancer risk,” the reports’ authors point out.

As the prevalence of high-grade cervical abnormalities and the incidence of cervical cancer continue to decline, “the proportion of false-positive findings [on cytology alone] is expected to increase significantly,” they caution.

As a result, the ACS suggests that physicians will likely have to consider a patient’s vaccination status in tandem with cervical cancer screening results to arrive at an accurate assessment.
 

Raising starting age to 25 years

Saslow also noted that there were several reasons why it is now recommended that screening begin at the age of 25 instead of the age of 21, as in earlier guidelines.

“Firstly, less than 1% of cervical cancers are diagnosed before the age of 25 – so this is about 130 cases per year,” she explained.

Thanks to HPV vaccination, this percentage is further declining, “so screening is just not beneficial at this age,” Saslow emphasized.

Furthermore, the rate of false positives is much higher in younger patients, and a false-positive result can have a negative impact on pregnancy outcomes, she added.

Saslow also dismissed an article in favor of cotesting instead of HPV testing alone. That study, carried out by researchers at Quest Diagnostics and the University of Pittsburgh Medical Center, recommended cotesting, claiming that primary HPV testing is significantly less likely to detect cervical precancers or cervical cancer than cotesting.

“These data come from parties with a vested interest in preserving cytology as a screening test,” Saslow told Medscape Medical News. She noted that “these findings are not at all credible as judged by the scientific community.”

On the basis of their own modeling, ACS researchers estimate that “starting with primary HPV testing at age 25 will prevent 13% more cervical cancers and 7% more cervical cancer deaths” in comparison with cytology (Pap testing alone) beginning at the age of 21, then cotesting at the age of 30, Saslow said in a statement.

“Our model showed we could do that with a 9% increase in follow-up procedures but with 45% fewer tests required overall,” she added.

The new recommendations are not expected to create any change in the type or amount of care required by providers, and patients will not notice any difference, inasmuch as cotesting and primary HPV testing are performed the same way in the examination room, she added.

“Resistance [to the changes] is expected – and is already occurring – from laboratories and manufacturers of tests that will no longer be used once we transition from cotesting and, less commonly, Pap testing to primary HPV testing,” Saslow said.

However, providers need to be aware that HPV infection, as with any sexually transmitted disease, is associated with a certain stigma, and they need to take care in discussing potential HPV infection with their patients.
 

Good method

Medscape Medical News approached Mark Einstein, MD, president of the ASCCP and professor and chair of obstetrics, gynecology, and reproductive health at Rutgers Biomedical and Health Sciences, Newark, New Jersey, to comment on the new guidelines.

“First and foremost,” he said, “everything we want to do when it comes to screening is to maximize the identification of picking up a cancer and minimize the risk or potential harm of not only screening itself but of missing cancers, so any strategy that improves on the sensitivity of picking up a cancer is a good method.”

Nevertheless, inasmuch as the ASCCP is one of the foremost organizations involved in cervical cancer screening and management, its members need more time to take a closer look at the updated ACS guidelines before they, together with sister organizations, such as the ACOG, release an official statement as to whether or not they fully endorse the new guidelines.

The United States Preventive Services Task Force recently endorsed primary HPV testing (starting at age 30), but it also said that an alternative strategy is cotesting for women between 30 and 65 years of age, Einstein observed.

Asked to comment on the article from Quest Diagnostics and the University of Pittsburgh that recommended cotesting instead of primary HPV testing, Einstein said that suggestion should not be dismissed out of hand.

The ASCCP has asked the authors of that study for their data in order conduct an independent assessment of it, largely because the study was retrospective in nature. Because of that, “there may have been a few pieces of information that were missing in true real-time fashion,” he said. “Not having [both the primary HPV testing and the cytology results] in front of me might change the next thing I might recommend to the patient,” Einstein explained.

The bottom line is that, when comparing primary HPV testing alone, cytology alone, and cotesting and rates of cervical cancer at 5 years, “the biggest driver for true performance of positive predictive value is HPV,” Einstein said.

Nevertheless, cotesting does bring more information into the equation compared with primary HPV testing alone, although it also increases the potential for harm, including the harm of overtesting and conducting needless colposcopies, he added.

That said, starting primary HPV testing at the age of 25 rather than the age of 30, as was previously recommended, is very likely to lead to detection of spurious HPV infections because HPV infections are very common among women in their 20s, Einstein pointed out.

“This, too, could potentially lead to more colposcopies, which may cause harm from the procedure itself but also create a certain amount of anxiety and concern, so there is some harm in testing for HPV at an earlier age as well,” Einstein said.

Saslow and Einstein have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The American Cancer Society (ACS) has released updated guidelines for cervical cancer screening. The key recommendation is that primary human papillomavirus (HPV) testing is the preferred screening method, starting at the age of 25 and repeated every 5 years.

In the past, guidelines for cervical cancer screening recommended cytology (the Pap test) starting at 21 years of age and repeated every 3 years. In more recent years, cotesting (with both Pap and HPV tests) has been recommended.

Since the last ACS guidelines on cervical cancer screening were published in 2012, two HPV tests have been approved by the Food and Drug Administration (FDA) for use in primary HPV screening.

The new “streamlined recommendations can improve compliance and reduce potential harms,” commented Debbie Saslow, PhD, managing director, HPV/GYN Cancers, American Cancer Society.

The updated guidelines were published online July 30 in CA: A Cancer Journal for Clinicians.

“We now have stronger evidence to support starting cervical cancer screening at a later age and to recommend screening with the HPV test as the preferred test,” Saslow told Medscape Medical News. This also reflects the phasing out of cytology and cotesting, she added.

“This update is based on decades of studies comparing the effectiveness of HPV testing to cytology and is bolstered by evidence of the impact of HPV vaccination, including a dramatic decline in cervical precancers and, more recently, cervical cancers among young women,” she said.

The American Society for Colposcopy and Cervical Pathology (ASCCP) said that it was preparing a response to these new guidelines, as is the American College of Obstetricians and Gynecologists (ACOG).
 

Cotesting or cytology alone

The updated guidelines recommend primary HPV testing as the preferred screening method for all women with a cervix. If primary HPV testing is not available, women should be screened with cotesting, which should also be performed every 5 years.

If only cytology is available, then women should be screened every 3 years.

The ACS authors point out that cotesting or cytology testing alone is still an acceptable option for cervical cancer screening, insofar as primary HPV testing using FDA-approved tests may not be available in some settings.

As more laboratories in the United States transition to FDA-approved tests for primary HPV testing, it is expected that the use of cotesting or cytology alone will be phased out.

The new guidelines also emphasize that women may discontinue screening at the age of 65 if they have not had cervical intraepitheal neoplasia of grade 2 or higher within the past 25 years and if they have tested negative over the past 10 years on all past screens.

The authors caution that past screens should only be considered negative if the patient has had two consecutive negative HPV tests or two consecutive negative cotests or three consecutive negative cytology tests within the past 10 years.

“These criteria do not apply to individuals who are currently under surveillance for abnormal screening results,” the authors state.

Women older than 65 for whom adequate documentation of prior screening is not available should continue to be screened until criteria for screening discontinuation are met, they add.

Screening may be discontinued among women with a limited life expectancy.
 

HPV vaccination

The authors note that HPV vaccination is expected to substantially change cervical cancer screening strategies.

In 2018, the National Immunization Survey–Teen, involving adolescents aged 13 to 17 years, showed that 68.1% of female patients were up to date on HPV vaccine recommendations, as were 51.1% of male patients.

“Cytology-based screening is much less efficient in vaccinated populations, as abnormal cytology disproportionately identifies minor abnormalities resulting from HPV types that are associated with lower cancer risk,” the reports’ authors point out.

As the prevalence of high-grade cervical abnormalities and the incidence of cervical cancer continue to decline, “the proportion of false-positive findings [on cytology alone] is expected to increase significantly,” they caution.

As a result, the ACS suggests that physicians will likely have to consider a patient’s vaccination status in tandem with cervical cancer screening results to arrive at an accurate assessment.
 

Raising starting age to 25 years

Saslow also noted that there were several reasons why it is now recommended that screening begin at the age of 25 instead of the age of 21, as in earlier guidelines.

“Firstly, less than 1% of cervical cancers are diagnosed before the age of 25 – so this is about 130 cases per year,” she explained.

Thanks to HPV vaccination, this percentage is further declining, “so screening is just not beneficial at this age,” Saslow emphasized.

Furthermore, the rate of false positives is much higher in younger patients, and a false-positive result can have a negative impact on pregnancy outcomes, she added.

Saslow also dismissed an article in favor of cotesting instead of HPV testing alone. That study, carried out by researchers at Quest Diagnostics and the University of Pittsburgh Medical Center, recommended cotesting, claiming that primary HPV testing is significantly less likely to detect cervical precancers or cervical cancer than cotesting.

“These data come from parties with a vested interest in preserving cytology as a screening test,” Saslow told Medscape Medical News. She noted that “these findings are not at all credible as judged by the scientific community.”

On the basis of their own modeling, ACS researchers estimate that “starting with primary HPV testing at age 25 will prevent 13% more cervical cancers and 7% more cervical cancer deaths” in comparison with cytology (Pap testing alone) beginning at the age of 21, then cotesting at the age of 30, Saslow said in a statement.

“Our model showed we could do that with a 9% increase in follow-up procedures but with 45% fewer tests required overall,” she added.

The new recommendations are not expected to create any change in the type or amount of care required by providers, and patients will not notice any difference, inasmuch as cotesting and primary HPV testing are performed the same way in the examination room, she added.

“Resistance [to the changes] is expected – and is already occurring – from laboratories and manufacturers of tests that will no longer be used once we transition from cotesting and, less commonly, Pap testing to primary HPV testing,” Saslow said.

However, providers need to be aware that HPV infection, as with any sexually transmitted disease, is associated with a certain stigma, and they need to take care in discussing potential HPV infection with their patients.
 

Good method

Medscape Medical News approached Mark Einstein, MD, president of the ASCCP and professor and chair of obstetrics, gynecology, and reproductive health at Rutgers Biomedical and Health Sciences, Newark, New Jersey, to comment on the new guidelines.

“First and foremost,” he said, “everything we want to do when it comes to screening is to maximize the identification of picking up a cancer and minimize the risk or potential harm of not only screening itself but of missing cancers, so any strategy that improves on the sensitivity of picking up a cancer is a good method.”

Nevertheless, inasmuch as the ASCCP is one of the foremost organizations involved in cervical cancer screening and management, its members need more time to take a closer look at the updated ACS guidelines before they, together with sister organizations, such as the ACOG, release an official statement as to whether or not they fully endorse the new guidelines.

The United States Preventive Services Task Force recently endorsed primary HPV testing (starting at age 30), but it also said that an alternative strategy is cotesting for women between 30 and 65 years of age, Einstein observed.

Asked to comment on the article from Quest Diagnostics and the University of Pittsburgh that recommended cotesting instead of primary HPV testing, Einstein said that suggestion should not be dismissed out of hand.

The ASCCP has asked the authors of that study for their data in order conduct an independent assessment of it, largely because the study was retrospective in nature. Because of that, “there may have been a few pieces of information that were missing in true real-time fashion,” he said. “Not having [both the primary HPV testing and the cytology results] in front of me might change the next thing I might recommend to the patient,” Einstein explained.

The bottom line is that, when comparing primary HPV testing alone, cytology alone, and cotesting and rates of cervical cancer at 5 years, “the biggest driver for true performance of positive predictive value is HPV,” Einstein said.

Nevertheless, cotesting does bring more information into the equation compared with primary HPV testing alone, although it also increases the potential for harm, including the harm of overtesting and conducting needless colposcopies, he added.

That said, starting primary HPV testing at the age of 25 rather than the age of 30, as was previously recommended, is very likely to lead to detection of spurious HPV infections because HPV infections are very common among women in their 20s, Einstein pointed out.

“This, too, could potentially lead to more colposcopies, which may cause harm from the procedure itself but also create a certain amount of anxiety and concern, so there is some harm in testing for HPV at an earlier age as well,” Einstein said.

Saslow and Einstein have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The American Cancer Society (ACS) has released updated guidelines for cervical cancer screening. The key recommendation is that primary human papillomavirus (HPV) testing is the preferred screening method, starting at the age of 25 and repeated every 5 years.

In the past, guidelines for cervical cancer screening recommended cytology (the Pap test) starting at 21 years of age and repeated every 3 years. In more recent years, cotesting (with both Pap and HPV tests) has been recommended.

Since the last ACS guidelines on cervical cancer screening were published in 2012, two HPV tests have been approved by the Food and Drug Administration (FDA) for use in primary HPV screening.

The new “streamlined recommendations can improve compliance and reduce potential harms,” commented Debbie Saslow, PhD, managing director, HPV/GYN Cancers, American Cancer Society.

The updated guidelines were published online July 30 in CA: A Cancer Journal for Clinicians.

“We now have stronger evidence to support starting cervical cancer screening at a later age and to recommend screening with the HPV test as the preferred test,” Saslow told Medscape Medical News. This also reflects the phasing out of cytology and cotesting, she added.

“This update is based on decades of studies comparing the effectiveness of HPV testing to cytology and is bolstered by evidence of the impact of HPV vaccination, including a dramatic decline in cervical precancers and, more recently, cervical cancers among young women,” she said.

The American Society for Colposcopy and Cervical Pathology (ASCCP) said that it was preparing a response to these new guidelines, as is the American College of Obstetricians and Gynecologists (ACOG).
 

Cotesting or cytology alone

The updated guidelines recommend primary HPV testing as the preferred screening method for all women with a cervix. If primary HPV testing is not available, women should be screened with cotesting, which should also be performed every 5 years.

If only cytology is available, then women should be screened every 3 years.

The ACS authors point out that cotesting or cytology testing alone is still an acceptable option for cervical cancer screening, insofar as primary HPV testing using FDA-approved tests may not be available in some settings.

As more laboratories in the United States transition to FDA-approved tests for primary HPV testing, it is expected that the use of cotesting or cytology alone will be phased out.

The new guidelines also emphasize that women may discontinue screening at the age of 65 if they have not had cervical intraepitheal neoplasia of grade 2 or higher within the past 25 years and if they have tested negative over the past 10 years on all past screens.

The authors caution that past screens should only be considered negative if the patient has had two consecutive negative HPV tests or two consecutive negative cotests or three consecutive negative cytology tests within the past 10 years.

“These criteria do not apply to individuals who are currently under surveillance for abnormal screening results,” the authors state.

Women older than 65 for whom adequate documentation of prior screening is not available should continue to be screened until criteria for screening discontinuation are met, they add.

Screening may be discontinued among women with a limited life expectancy.
 

HPV vaccination

The authors note that HPV vaccination is expected to substantially change cervical cancer screening strategies.

In 2018, the National Immunization Survey–Teen, involving adolescents aged 13 to 17 years, showed that 68.1% of female patients were up to date on HPV vaccine recommendations, as were 51.1% of male patients.

“Cytology-based screening is much less efficient in vaccinated populations, as abnormal cytology disproportionately identifies minor abnormalities resulting from HPV types that are associated with lower cancer risk,” the reports’ authors point out.

As the prevalence of high-grade cervical abnormalities and the incidence of cervical cancer continue to decline, “the proportion of false-positive findings [on cytology alone] is expected to increase significantly,” they caution.

As a result, the ACS suggests that physicians will likely have to consider a patient’s vaccination status in tandem with cervical cancer screening results to arrive at an accurate assessment.
 

Raising starting age to 25 years

Saslow also noted that there were several reasons why it is now recommended that screening begin at the age of 25 instead of the age of 21, as in earlier guidelines.

“Firstly, less than 1% of cervical cancers are diagnosed before the age of 25 – so this is about 130 cases per year,” she explained.

Thanks to HPV vaccination, this percentage is further declining, “so screening is just not beneficial at this age,” Saslow emphasized.

Furthermore, the rate of false positives is much higher in younger patients, and a false-positive result can have a negative impact on pregnancy outcomes, she added.

Saslow also dismissed an article in favor of cotesting instead of HPV testing alone. That study, carried out by researchers at Quest Diagnostics and the University of Pittsburgh Medical Center, recommended cotesting, claiming that primary HPV testing is significantly less likely to detect cervical precancers or cervical cancer than cotesting.

“These data come from parties with a vested interest in preserving cytology as a screening test,” Saslow told Medscape Medical News. She noted that “these findings are not at all credible as judged by the scientific community.”

On the basis of their own modeling, ACS researchers estimate that “starting with primary HPV testing at age 25 will prevent 13% more cervical cancers and 7% more cervical cancer deaths” in comparison with cytology (Pap testing alone) beginning at the age of 21, then cotesting at the age of 30, Saslow said in a statement.

“Our model showed we could do that with a 9% increase in follow-up procedures but with 45% fewer tests required overall,” she added.

The new recommendations are not expected to create any change in the type or amount of care required by providers, and patients will not notice any difference, inasmuch as cotesting and primary HPV testing are performed the same way in the examination room, she added.

“Resistance [to the changes] is expected – and is already occurring – from laboratories and manufacturers of tests that will no longer be used once we transition from cotesting and, less commonly, Pap testing to primary HPV testing,” Saslow said.

However, providers need to be aware that HPV infection, as with any sexually transmitted disease, is associated with a certain stigma, and they need to take care in discussing potential HPV infection with their patients.
 

Good method

Medscape Medical News approached Mark Einstein, MD, president of the ASCCP and professor and chair of obstetrics, gynecology, and reproductive health at Rutgers Biomedical and Health Sciences, Newark, New Jersey, to comment on the new guidelines.

“First and foremost,” he said, “everything we want to do when it comes to screening is to maximize the identification of picking up a cancer and minimize the risk or potential harm of not only screening itself but of missing cancers, so any strategy that improves on the sensitivity of picking up a cancer is a good method.”

Nevertheless, inasmuch as the ASCCP is one of the foremost organizations involved in cervical cancer screening and management, its members need more time to take a closer look at the updated ACS guidelines before they, together with sister organizations, such as the ACOG, release an official statement as to whether or not they fully endorse the new guidelines.

The United States Preventive Services Task Force recently endorsed primary HPV testing (starting at age 30), but it also said that an alternative strategy is cotesting for women between 30 and 65 years of age, Einstein observed.

Asked to comment on the article from Quest Diagnostics and the University of Pittsburgh that recommended cotesting instead of primary HPV testing, Einstein said that suggestion should not be dismissed out of hand.

The ASCCP has asked the authors of that study for their data in order conduct an independent assessment of it, largely because the study was retrospective in nature. Because of that, “there may have been a few pieces of information that were missing in true real-time fashion,” he said. “Not having [both the primary HPV testing and the cytology results] in front of me might change the next thing I might recommend to the patient,” Einstein explained.

The bottom line is that, when comparing primary HPV testing alone, cytology alone, and cotesting and rates of cervical cancer at 5 years, “the biggest driver for true performance of positive predictive value is HPV,” Einstein said.

Nevertheless, cotesting does bring more information into the equation compared with primary HPV testing alone, although it also increases the potential for harm, including the harm of overtesting and conducting needless colposcopies, he added.

That said, starting primary HPV testing at the age of 25 rather than the age of 30, as was previously recommended, is very likely to lead to detection of spurious HPV infections because HPV infections are very common among women in their 20s, Einstein pointed out.

“This, too, could potentially lead to more colposcopies, which may cause harm from the procedure itself but also create a certain amount of anxiety and concern, so there is some harm in testing for HPV at an earlier age as well,” Einstein said.

Saslow and Einstein have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

In individuals with inflammatory bowel disease and primary sclerosing cholangitis, younger age at diagnosis, male sex, and Afro-Caribbean heritage were significant risk factors for liver transplantation and disease-related death, based on a 10-year prospective population-based study.

These factors should be incorporated into the design of clinical trials, models for predicting disease, and studies of prognostic biomarkers for primary sclerosing cholangitis, Palak T. Trivedi, MBBS, MRCP, of the Universty of Birmingham (England) wrote with his associates in Gastroenterology.

The researchers identified newly diagnosed cases from a national health care registry in England between 2006 and 2016 (data on outcomes were collected through mid-2019). In all, 284,560 individuals had a new diagnosis of inflammatory bowel disease, among whom 2,588 also had primary sclerosing cholangitis. The investigators tracked deaths, liver transplantation, colonic resection, cholecystectomy, and diagnoses of colorectal cancer, cholangiosarcoma, and cancers of the pancreas, gallbladder, and liver. They evaluated rates of these outcomes among individuals with both primary sclerosing cholangitis and inflammatory bowel disease (PSC-IBD) and those with IBD only.

After controlling for sex, race, socioeconomic level, comorbidities, and older age, the researchers found that both men and women with PSC-IBD had a significantly greater risk for all-cause mortality, compared with individuals with IBD alone (hazard ratio, 3.20; 95% confidence interval, 3.01-3.40; P less than .001). Strikingly, individuals who were diagnosed with PSC when they were younger than 40 years had a more than sevenfold higher rate of all-cause mortality, compared with individuals with IBD only. In contrast, the incidence rate ratio for individuals diagnosed with PSC when they were older than 60 years was less than 1.5, compared with IBD-only individuals.

Having PSC and ulcerative colitis, being younger when diagnosed with PSC, and being of Afro-Carribean heritage all correlated with higher incidence of liver transplantation or death related to PSC. Individuals with PSC-IBD who were of Afro-Caribbean heritage had an approximately twofold greater risk for liver transplantation or PSC-related death compared with Whites (adjusted HR, 2.05; 95% CI, 1.14-3.70; P = .016). In contrast, women with PSC-IBD were at significantly lower risk for liver transplantation or disease-related death than were men (adjusted HR, 0.74; 95% CI, 0.57-0.97; P = .026).

“The onset of PSC confers heightened risks of all hepatobiliary malignancies, although annual imaging surveillance may associate with a reduced risk of cancer-related death,” the investigators found. Among patients with hepatobiliary cancer, annual imaging was associated with a twofold decrease in risk for cancer-related death (HR, 0.43; 95% CI, 0.23-0.80; P = .037).

Colorectal cancer tended to occur at a younger age among individuals with PSC-IBD, compared with those with IBD alone (median ages at diagnosis, 59 vs. 69 years; P less than .001). Notably, individuals with PSC diagnosed under age 50 years had about a fivefold higher incidence of colorectal cancer than did those with IBD alone, while those diagnosed at older ages had only about a twofold increase. With regard to colectomy, men diagnosed with PSC at younger ages were at the greatest risk, compared with women or individuals diagnosed after age 50 years. Individuals with ulcerative colitis and PSC had a 40% greater risk for colectomy risk than did IBD-only individuals (time-dependent adjusted HR, 1.65; 95% CI, 1.45-1.85; P less than .001).

“Whilst all-cause mortality rates increase with age, younger patients [with PSC] show a disproportionately increased incidence of liver transplantation, PSC-related death, and colorectal cancer,” the researchers concluded. “Consideration of age at diagnosis should therefore be applied in the stratification of patients for future clinical trials, disease prediction models, and prognostic biomarker discovery.”

Dr. Trivedi disclosed support from the National Institute for Health Research Birmingham Biomedical Research Centre, at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham. No other disclosures were reported.

SOURCE: Trivedi PJ et al. Gastroenterology. 2020 May 19. doi: 10.1053/j.gastro.2020.05.049.
 

In individuals with inflammatory bowel disease and primary sclerosing cholangitis, younger age at diagnosis, male sex, and Afro-Caribbean heritage were significant risk factors for liver transplantation and disease-related death, based on a 10-year prospective population-based study.

These factors should be incorporated into the design of clinical trials, models for predicting disease, and studies of prognostic biomarkers for primary sclerosing cholangitis, Palak T. Trivedi, MBBS, MRCP, of the Universty of Birmingham (England) wrote with his associates in Gastroenterology.

The researchers identified newly diagnosed cases from a national health care registry in England between 2006 and 2016 (data on outcomes were collected through mid-2019). In all, 284,560 individuals had a new diagnosis of inflammatory bowel disease, among whom 2,588 also had primary sclerosing cholangitis. The investigators tracked deaths, liver transplantation, colonic resection, cholecystectomy, and diagnoses of colorectal cancer, cholangiosarcoma, and cancers of the pancreas, gallbladder, and liver. They evaluated rates of these outcomes among individuals with both primary sclerosing cholangitis and inflammatory bowel disease (PSC-IBD) and those with IBD only.

After controlling for sex, race, socioeconomic level, comorbidities, and older age, the researchers found that both men and women with PSC-IBD had a significantly greater risk for all-cause mortality, compared with individuals with IBD alone (hazard ratio, 3.20; 95% confidence interval, 3.01-3.40; P less than .001). Strikingly, individuals who were diagnosed with PSC when they were younger than 40 years had a more than sevenfold higher rate of all-cause mortality, compared with individuals with IBD only. In contrast, the incidence rate ratio for individuals diagnosed with PSC when they were older than 60 years was less than 1.5, compared with IBD-only individuals.

Having PSC and ulcerative colitis, being younger when diagnosed with PSC, and being of Afro-Carribean heritage all correlated with higher incidence of liver transplantation or death related to PSC. Individuals with PSC-IBD who were of Afro-Caribbean heritage had an approximately twofold greater risk for liver transplantation or PSC-related death compared with Whites (adjusted HR, 2.05; 95% CI, 1.14-3.70; P = .016). In contrast, women with PSC-IBD were at significantly lower risk for liver transplantation or disease-related death than were men (adjusted HR, 0.74; 95% CI, 0.57-0.97; P = .026).

“The onset of PSC confers heightened risks of all hepatobiliary malignancies, although annual imaging surveillance may associate with a reduced risk of cancer-related death,” the investigators found. Among patients with hepatobiliary cancer, annual imaging was associated with a twofold decrease in risk for cancer-related death (HR, 0.43; 95% CI, 0.23-0.80; P = .037).

Colorectal cancer tended to occur at a younger age among individuals with PSC-IBD, compared with those with IBD alone (median ages at diagnosis, 59 vs. 69 years; P less than .001). Notably, individuals with PSC diagnosed under age 50 years had about a fivefold higher incidence of colorectal cancer than did those with IBD alone, while those diagnosed at older ages had only about a twofold increase. With regard to colectomy, men diagnosed with PSC at younger ages were at the greatest risk, compared with women or individuals diagnosed after age 50 years. Individuals with ulcerative colitis and PSC had a 40% greater risk for colectomy risk than did IBD-only individuals (time-dependent adjusted HR, 1.65; 95% CI, 1.45-1.85; P less than .001).

“Whilst all-cause mortality rates increase with age, younger patients [with PSC] show a disproportionately increased incidence of liver transplantation, PSC-related death, and colorectal cancer,” the researchers concluded. “Consideration of age at diagnosis should therefore be applied in the stratification of patients for future clinical trials, disease prediction models, and prognostic biomarker discovery.”

Dr. Trivedi disclosed support from the National Institute for Health Research Birmingham Biomedical Research Centre, at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham. No other disclosures were reported.

SOURCE: Trivedi PJ et al. Gastroenterology. 2020 May 19. doi: 10.1053/j.gastro.2020.05.049.
 

In individuals with inflammatory bowel disease and primary sclerosing cholangitis, younger age at diagnosis, male sex, and Afro-Caribbean heritage were significant risk factors for liver transplantation and disease-related death, based on a 10-year prospective population-based study.

These factors should be incorporated into the design of clinical trials, models for predicting disease, and studies of prognostic biomarkers for primary sclerosing cholangitis, Palak T. Trivedi, MBBS, MRCP, of the Universty of Birmingham (England) wrote with his associates in Gastroenterology.

The researchers identified newly diagnosed cases from a national health care registry in England between 2006 and 2016 (data on outcomes were collected through mid-2019). In all, 284,560 individuals had a new diagnosis of inflammatory bowel disease, among whom 2,588 also had primary sclerosing cholangitis. The investigators tracked deaths, liver transplantation, colonic resection, cholecystectomy, and diagnoses of colorectal cancer, cholangiosarcoma, and cancers of the pancreas, gallbladder, and liver. They evaluated rates of these outcomes among individuals with both primary sclerosing cholangitis and inflammatory bowel disease (PSC-IBD) and those with IBD only.

After controlling for sex, race, socioeconomic level, comorbidities, and older age, the researchers found that both men and women with PSC-IBD had a significantly greater risk for all-cause mortality, compared with individuals with IBD alone (hazard ratio, 3.20; 95% confidence interval, 3.01-3.40; P less than .001). Strikingly, individuals who were diagnosed with PSC when they were younger than 40 years had a more than sevenfold higher rate of all-cause mortality, compared with individuals with IBD only. In contrast, the incidence rate ratio for individuals diagnosed with PSC when they were older than 60 years was less than 1.5, compared with IBD-only individuals.

Having PSC and ulcerative colitis, being younger when diagnosed with PSC, and being of Afro-Carribean heritage all correlated with higher incidence of liver transplantation or death related to PSC. Individuals with PSC-IBD who were of Afro-Caribbean heritage had an approximately twofold greater risk for liver transplantation or PSC-related death compared with Whites (adjusted HR, 2.05; 95% CI, 1.14-3.70; P = .016). In contrast, women with PSC-IBD were at significantly lower risk for liver transplantation or disease-related death than were men (adjusted HR, 0.74; 95% CI, 0.57-0.97; P = .026).

“The onset of PSC confers heightened risks of all hepatobiliary malignancies, although annual imaging surveillance may associate with a reduced risk of cancer-related death,” the investigators found. Among patients with hepatobiliary cancer, annual imaging was associated with a twofold decrease in risk for cancer-related death (HR, 0.43; 95% CI, 0.23-0.80; P = .037).

Colorectal cancer tended to occur at a younger age among individuals with PSC-IBD, compared with those with IBD alone (median ages at diagnosis, 59 vs. 69 years; P less than .001). Notably, individuals with PSC diagnosed under age 50 years had about a fivefold higher incidence of colorectal cancer than did those with IBD alone, while those diagnosed at older ages had only about a twofold increase. With regard to colectomy, men diagnosed with PSC at younger ages were at the greatest risk, compared with women or individuals diagnosed after age 50 years. Individuals with ulcerative colitis and PSC had a 40% greater risk for colectomy risk than did IBD-only individuals (time-dependent adjusted HR, 1.65; 95% CI, 1.45-1.85; P less than .001).

“Whilst all-cause mortality rates increase with age, younger patients [with PSC] show a disproportionately increased incidence of liver transplantation, PSC-related death, and colorectal cancer,” the researchers concluded. “Consideration of age at diagnosis should therefore be applied in the stratification of patients for future clinical trials, disease prediction models, and prognostic biomarker discovery.”

Dr. Trivedi disclosed support from the National Institute for Health Research Birmingham Biomedical Research Centre, at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham. No other disclosures were reported.

SOURCE: Trivedi PJ et al. Gastroenterology. 2020 May 19. doi: 10.1053/j.gastro.2020.05.049.