Key clinical point: Baseline neutrophil-to-lymphocyte ratio (NLR), and delta NLR were predictors of overall survival in HCC patients treated with stereotactic body radiation therapy; however, neither platelet-to-lymphocyte ratio (PLR) nor delta PLR were predictive of survival.

Major finding:  Elevations in NLR and delta-NLR (dNLR) prior to SBRT in hepatocellular carcinoma patients were significant predictors of worse overall survival (P <0.001 and P = 0.011, respectively). 

Study details: The data come from a retrospective study of 93 adult HCC patients treated with stereotactic body radiation therapy (SBRT), with a median follow-up of 10.7 months.

Disclosures: The study was supported by the Tri-Service General Hospital. The researchers had no financial conflicts to disclose.  

Source: Hsiang C-W et al. J Hepatocell Carcinoma. 2021 Oct 29. doi: 10.2147/JHC.S334933.

Key clinical point: Baseline neutrophil-to-lymphocyte ratio (NLR), and delta NLR were predictors of overall survival in HCC patients treated with stereotactic body radiation therapy; however, neither platelet-to-lymphocyte ratio (PLR) nor delta PLR were predictive of survival.

Major finding:  Elevations in NLR and delta-NLR (dNLR) prior to SBRT in hepatocellular carcinoma patients were significant predictors of worse overall survival (P <0.001 and P = 0.011, respectively). 

Study details: The data come from a retrospective study of 93 adult HCC patients treated with stereotactic body radiation therapy (SBRT), with a median follow-up of 10.7 months.

Disclosures: The study was supported by the Tri-Service General Hospital. The researchers had no financial conflicts to disclose.  

Source: Hsiang C-W et al. J Hepatocell Carcinoma. 2021 Oct 29. doi: 10.2147/JHC.S334933.

Key clinical point: Baseline neutrophil-to-lymphocyte ratio (NLR), and delta NLR were predictors of overall survival in HCC patients treated with stereotactic body radiation therapy; however, neither platelet-to-lymphocyte ratio (PLR) nor delta PLR were predictive of survival.

Major finding:  Elevations in NLR and delta-NLR (dNLR) prior to SBRT in hepatocellular carcinoma patients were significant predictors of worse overall survival (P <0.001 and P = 0.011, respectively). 

Study details: The data come from a retrospective study of 93 adult HCC patients treated with stereotactic body radiation therapy (SBRT), with a median follow-up of 10.7 months.

Disclosures: The study was supported by the Tri-Service General Hospital. The researchers had no financial conflicts to disclose.  

Source: Hsiang C-W et al. J Hepatocell Carcinoma. 2021 Oct 29. doi: 10.2147/JHC.S334933.

Key clinical point: Fever following radiofrequency ablation in hepatocellular carcinoma patients was independently associated with younger age, low serum albumin level, general anesthesia, tumor size, and tumor number.

Major finding:  The adjusted odds ratios for the independent predictors of fever in these patients were 0.96 for younger age, 0.49 for low serum albumin level, 2.06 for general anesthesia, 1.52 for tumor size, and 1.71 for tumor number. HCC patients who developed fevers after radiofrequency ablation also had significantly longer hospital stays than those without fevers (9.06 days vs 5.50 days).

Study details: The data come from a retrospective study of 272 adults with new or recurrent hepatocellular carcinoma who underwent ultrasonography-guided radiofrequency ablation (RFA) between April 2014 and February 2019.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Chen P-Y et al. Cancers (Basel). 2021 Oct 22. doi: 10.3390/cancers13215303.

Key clinical point: Fever following radiofrequency ablation in hepatocellular carcinoma patients was independently associated with younger age, low serum albumin level, general anesthesia, tumor size, and tumor number.

Major finding:  The adjusted odds ratios for the independent predictors of fever in these patients were 0.96 for younger age, 0.49 for low serum albumin level, 2.06 for general anesthesia, 1.52 for tumor size, and 1.71 for tumor number. HCC patients who developed fevers after radiofrequency ablation also had significantly longer hospital stays than those without fevers (9.06 days vs 5.50 days).

Study details: The data come from a retrospective study of 272 adults with new or recurrent hepatocellular carcinoma who underwent ultrasonography-guided radiofrequency ablation (RFA) between April 2014 and February 2019.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Chen P-Y et al. Cancers (Basel). 2021 Oct 22. doi: 10.3390/cancers13215303.

Key clinical point: Fever following radiofrequency ablation in hepatocellular carcinoma patients was independently associated with younger age, low serum albumin level, general anesthesia, tumor size, and tumor number.

Major finding:  The adjusted odds ratios for the independent predictors of fever in these patients were 0.96 for younger age, 0.49 for low serum albumin level, 2.06 for general anesthesia, 1.52 for tumor size, and 1.71 for tumor number. HCC patients who developed fevers after radiofrequency ablation also had significantly longer hospital stays than those without fevers (9.06 days vs 5.50 days).

Study details: The data come from a retrospective study of 272 adults with new or recurrent hepatocellular carcinoma who underwent ultrasonography-guided radiofrequency ablation (RFA) between April 2014 and February 2019.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Chen P-Y et al. Cancers (Basel). 2021 Oct 22. doi: 10.3390/cancers13215303.

Key clinical point: A multi-dimensional “combined index” model using artificial intelligence and SHG/TPEF microscopy was a stronger predictor of HCC recurrence than alpha fetoprotein levels in HCC patients who underwent curative hepatectomy.

Major finding:  The sensitivity and specificity of the combined index model was 81.8% and 90.5%, respectively, compared to 68.2% and 47.6%, respectively, for alpha fetoprotein level as a predictor of recurrent HCC.

Study details: The data come from a study of 81 adults with hepatocellular carcinoma who underwent curative intent hepatectomy. Researchers used fibrotic features of resected tissue to create a recurrence prediction model.

Disclosures: The study was supported by the Taiwan Ministry of Health. The researchers had no financial conflicts to disclose.

Source: Liu I-T et al. Cancers (Basel). 2021 Oct 23. doi: 10.3390/cancers13215323.

Key clinical point: A multi-dimensional “combined index” model using artificial intelligence and SHG/TPEF microscopy was a stronger predictor of HCC recurrence than alpha fetoprotein levels in HCC patients who underwent curative hepatectomy.

Major finding:  The sensitivity and specificity of the combined index model was 81.8% and 90.5%, respectively, compared to 68.2% and 47.6%, respectively, for alpha fetoprotein level as a predictor of recurrent HCC.

Study details: The data come from a study of 81 adults with hepatocellular carcinoma who underwent curative intent hepatectomy. Researchers used fibrotic features of resected tissue to create a recurrence prediction model.

Disclosures: The study was supported by the Taiwan Ministry of Health. The researchers had no financial conflicts to disclose.

Source: Liu I-T et al. Cancers (Basel). 2021 Oct 23. doi: 10.3390/cancers13215323.

Key clinical point: A multi-dimensional “combined index” model using artificial intelligence and SHG/TPEF microscopy was a stronger predictor of HCC recurrence than alpha fetoprotein levels in HCC patients who underwent curative hepatectomy.

Major finding:  The sensitivity and specificity of the combined index model was 81.8% and 90.5%, respectively, compared to 68.2% and 47.6%, respectively, for alpha fetoprotein level as a predictor of recurrent HCC.

Study details: The data come from a study of 81 adults with hepatocellular carcinoma who underwent curative intent hepatectomy. Researchers used fibrotic features of resected tissue to create a recurrence prediction model.

Disclosures: The study was supported by the Taiwan Ministry of Health. The researchers had no financial conflicts to disclose.

Source: Liu I-T et al. Cancers (Basel). 2021 Oct 23. doi: 10.3390/cancers13215323.

Key clinical point: Liver decompensation is a common late complication in HCC patients treated with SIRT, although overall survival rates surpass those in patients treated with sorafenib.

Major finding:  Liver decompensation, based on a Child-Pugh (CP) score of B7 or higher, occurred in significantly more HCC patients treated with SIRT compared to those treated with sorafenib (62% vs 27%) in a case-matched analysis. However, the median overall survival was significantly longer in SIRT-treated patients compared with sorafenib patients (16 months vs 9 months).

Study details: The data come from 69 adults with advanced HCC who underwent selective internal radiation therapy (SIRT) and had not developed radioembolization-induced liver disease (REILD).

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: van Doorn DJ et al. Cancers (Basel). 2021 Oct 29. doi: 10.3390/cancers13215427.

Key clinical point: Liver decompensation is a common late complication in HCC patients treated with SIRT, although overall survival rates surpass those in patients treated with sorafenib.

Major finding:  Liver decompensation, based on a Child-Pugh (CP) score of B7 or higher, occurred in significantly more HCC patients treated with SIRT compared to those treated with sorafenib (62% vs 27%) in a case-matched analysis. However, the median overall survival was significantly longer in SIRT-treated patients compared with sorafenib patients (16 months vs 9 months).

Study details: The data come from 69 adults with advanced HCC who underwent selective internal radiation therapy (SIRT) and had not developed radioembolization-induced liver disease (REILD).

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: van Doorn DJ et al. Cancers (Basel). 2021 Oct 29. doi: 10.3390/cancers13215427.

Key clinical point: Liver decompensation is a common late complication in HCC patients treated with SIRT, although overall survival rates surpass those in patients treated with sorafenib.

Major finding:  Liver decompensation, based on a Child-Pugh (CP) score of B7 or higher, occurred in significantly more HCC patients treated with SIRT compared to those treated with sorafenib (62% vs 27%) in a case-matched analysis. However, the median overall survival was significantly longer in SIRT-treated patients compared with sorafenib patients (16 months vs 9 months).

Study details: The data come from 69 adults with advanced HCC who underwent selective internal radiation therapy (SIRT) and had not developed radioembolization-induced liver disease (REILD).

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: van Doorn DJ et al. Cancers (Basel). 2021 Oct 29. doi: 10.3390/cancers13215427.

Key clinical point: Patients who underwent laparoscopic liver resection for HCC had fewer complications and similar long-term outcomes to those who had open resection procedures.

Major finding:  Patients in the laparoscopic group had significantly fewer complications of Clavien-Dindo grade III or higher compared to those in the open group (14% vs 29%, P = .01). Overall survival rates at 1, 3, and 5 years were similar between the laparoscopic group and the open group, 90.9%, 79.3%, 70.5% vs 91.3%, 88.5%, 83.1%, respectively, and cumulative recurrence rates were not significantly different between the groups.

Study details: The data come from a retrospective study of 149 adults who underwent either laparoscopic or open liver resection between January 2008 and December 2019. Primary outcomes of overall survival and cumulative incidence of recurrence were assessed after propensity score matching.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Ivanics T et al. Surgery. 2021 Nov 3. doi: 10.1016/j.surg.2021.10.017.

Key clinical point: Patients who underwent laparoscopic liver resection for HCC had fewer complications and similar long-term outcomes to those who had open resection procedures.

Major finding:  Patients in the laparoscopic group had significantly fewer complications of Clavien-Dindo grade III or higher compared to those in the open group (14% vs 29%, P = .01). Overall survival rates at 1, 3, and 5 years were similar between the laparoscopic group and the open group, 90.9%, 79.3%, 70.5% vs 91.3%, 88.5%, 83.1%, respectively, and cumulative recurrence rates were not significantly different between the groups.

Study details: The data come from a retrospective study of 149 adults who underwent either laparoscopic or open liver resection between January 2008 and December 2019. Primary outcomes of overall survival and cumulative incidence of recurrence were assessed after propensity score matching.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Ivanics T et al. Surgery. 2021 Nov 3. doi: 10.1016/j.surg.2021.10.017.

Key clinical point: Patients who underwent laparoscopic liver resection for HCC had fewer complications and similar long-term outcomes to those who had open resection procedures.

Major finding:  Patients in the laparoscopic group had significantly fewer complications of Clavien-Dindo grade III or higher compared to those in the open group (14% vs 29%, P = .01). Overall survival rates at 1, 3, and 5 years were similar between the laparoscopic group and the open group, 90.9%, 79.3%, 70.5% vs 91.3%, 88.5%, 83.1%, respectively, and cumulative recurrence rates were not significantly different between the groups.

Study details: The data come from a retrospective study of 149 adults who underwent either laparoscopic or open liver resection between January 2008 and December 2019. Primary outcomes of overall survival and cumulative incidence of recurrence were assessed after propensity score matching.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Ivanics T et al. Surgery. 2021 Nov 3. doi: 10.1016/j.surg.2021.10.017.

LAS VEGAS – New results from a single center, retrospective analysis suggest that individuals with diabetes and pancreatic cysts have larger cyst sizes at diagnosis, and a faster subsequent cyst growth rate. Smoking was independently associated with faster growth rate.

iStock/ThinkStock

Most pancreatic cancer patients were previously diagnosed with hyperglycemia and diabetes, and pancreatic cancer can cause diabetes. “This sort of dual causality raises questions as to whether or not hyperglycemia, or the new diagnosis of diabetes itself, could be a harbinger of cancer or precancer. And should these patients be more closely monitored?” David Robbins, MD, said in an interview.

MDedge News

Dr. Robbins, associate professor of medicine and program director in gastroenterology in the Northwell Health System, New York, presented the study at the annual meeting of the American College of Gastroenterology.

Faster growth rates of pancreatic cysts in the presence of diabetes are important because they represent a potential mark for cyst aggressiveness. “So the question really is, in the setting of diabetes, are there factors perhaps circulating in the bloodstream, or other intrinsic factors, that make these cysts more dangerous and require a different surveillance approach than someone who doesn’t have diabetes? We have (surveillance) guidelines that address the average population, but they don’t really hone in on what do you do with (individuals with diabetes),” Dr. Robbins said during the presentation.

The study could have implications for screening, said session moderator Dayna Early, MD, professor of medicine at Washington University and director of endoscopy at Barnes Jewish Hospital, both in St. Louis. “I think this is important information to guide us to look more closely at patients with diabetes who do have pancreatic cysts,” she said in an interview.

The study included 177 adults with pancreatic cysts or abnormal imaging results between 2013 and 2020. Sixty-five percent were female, and the mean age was 65.4 years; 64% were White, 10% were Black, and 8.5% were Asian. Among the participants, 24.8% were smokers and 32.2% had type 2 diabetes.

Patients with diabetes had larger cyst sizes (2.23 cm versus 2.76 cm), as well as a higher annual cyst growth rate (1.90 cm versus 1.30 cm). Cyst size and growth rate were similar between patients with controlled and uncontrolled diabetes. Smoking was associated with a larger cyst size overall (2.2 cm versus 1.81 cm), and were larger still among patients with diabetes who smoked (2.35 cm).

Seventy-one patients went on to have pathologic confirmation by endoscopic ultrasound-guided fine needle aspiration. “In the diabetic group, two developed adenocarcinoma, six of the nondiabetics developed adenocarcinoma, and there was no difference in CEA or serum CA 19-9,” Dr. Robbins said during his presentation.

Of 28 patients diagnosed with pancreatic cancer, 13 had type 2 diabetes.
 

Defining danger

There remains uncertainty about what cyst growth rate is most dangerous. Some guidelines recommend that individuals with new-onset or worsening diabetes and intraductal papillary mucinous neoplasm or mucinous cystic neoplasm cysts, or cysts alone that are growing faster than 3 mm per year, may be at significantly increased risk of pancreatic cancer. These guidelines recommend that they be screened with short-interval magnetic resonance imaging or endoscopic ultrasound (EUS) fine needle aspiration. However, this recommendation is conditional and is backed by a very low level of evidence.

Other reports have shown varying risks at different growth rates. “It’s not really clear at this point. And that’s why I think, while our study is small and exploratory, this is a particular area that is relatively easy to evaluate. We have huge databases of pancreatic cyst evolution, and we know that 30 million Americans have diabetes. So, the next obvious study is to do a more systematic look at that, and work towards refining and making sense of these divergent guidelines, all of which are saying the same thing but using different threshold numbers,” said Dr. Robbins.

The next step is do larger, multicenter studies in the context of other risk factors such as family history and smoking, but the current finding represents an opportunity to catch at least some pancreatic cancers earlier, according to Dr. Robbins. He suggested that individuals with diabetes who are diagnosed with a pancreatic cyst should be referred to a gastroenterologist or another specialist to track cyst growth. “That is going to miss a lot of folks who didn’t get imaging for whatever reason (and so don’t have a cyst identified), but it is an early opportunity, and it’s better than what we’re doing now.”

During the talk, Dr. Robbins said, “Given the ease, availability and low cost of diabetes screening in the general clinic population, we encourage the inclusion of HbA1c and fasting glucose in algorithms for pancreatic cyst surveillance.”

Dr. Early found the suggestion intriguing, but wasn’t ready to lend full support. “I think looking at the suggestion of possibly monitoring hemoglobin A1c levels was novel. I don’t know that we’ll necessarily adopt that as standard practice, but that’s something I think that could be looked at in the future as a way to help risk stratify whether patients need to be surveyed more frequently,” she said.

Dr. Robbins and Dr. Early have no relevant financial disclosures.

LAS VEGAS – New results from a single center, retrospective analysis suggest that individuals with diabetes and pancreatic cysts have larger cyst sizes at diagnosis, and a faster subsequent cyst growth rate. Smoking was independently associated with faster growth rate.

iStock/ThinkStock

Most pancreatic cancer patients were previously diagnosed with hyperglycemia and diabetes, and pancreatic cancer can cause diabetes. “This sort of dual causality raises questions as to whether or not hyperglycemia, or the new diagnosis of diabetes itself, could be a harbinger of cancer or precancer. And should these patients be more closely monitored?” David Robbins, MD, said in an interview.

MDedge News

Dr. Robbins, associate professor of medicine and program director in gastroenterology in the Northwell Health System, New York, presented the study at the annual meeting of the American College of Gastroenterology.

Faster growth rates of pancreatic cysts in the presence of diabetes are important because they represent a potential mark for cyst aggressiveness. “So the question really is, in the setting of diabetes, are there factors perhaps circulating in the bloodstream, or other intrinsic factors, that make these cysts more dangerous and require a different surveillance approach than someone who doesn’t have diabetes? We have (surveillance) guidelines that address the average population, but they don’t really hone in on what do you do with (individuals with diabetes),” Dr. Robbins said during the presentation.

The study could have implications for screening, said session moderator Dayna Early, MD, professor of medicine at Washington University and director of endoscopy at Barnes Jewish Hospital, both in St. Louis. “I think this is important information to guide us to look more closely at patients with diabetes who do have pancreatic cysts,” she said in an interview.

The study included 177 adults with pancreatic cysts or abnormal imaging results between 2013 and 2020. Sixty-five percent were female, and the mean age was 65.4 years; 64% were White, 10% were Black, and 8.5% were Asian. Among the participants, 24.8% were smokers and 32.2% had type 2 diabetes.

Patients with diabetes had larger cyst sizes (2.23 cm versus 2.76 cm), as well as a higher annual cyst growth rate (1.90 cm versus 1.30 cm). Cyst size and growth rate were similar between patients with controlled and uncontrolled diabetes. Smoking was associated with a larger cyst size overall (2.2 cm versus 1.81 cm), and were larger still among patients with diabetes who smoked (2.35 cm).

Seventy-one patients went on to have pathologic confirmation by endoscopic ultrasound-guided fine needle aspiration. “In the diabetic group, two developed adenocarcinoma, six of the nondiabetics developed adenocarcinoma, and there was no difference in CEA or serum CA 19-9,” Dr. Robbins said during his presentation.

Of 28 patients diagnosed with pancreatic cancer, 13 had type 2 diabetes.
 

Defining danger

There remains uncertainty about what cyst growth rate is most dangerous. Some guidelines recommend that individuals with new-onset or worsening diabetes and intraductal papillary mucinous neoplasm or mucinous cystic neoplasm cysts, or cysts alone that are growing faster than 3 mm per year, may be at significantly increased risk of pancreatic cancer. These guidelines recommend that they be screened with short-interval magnetic resonance imaging or endoscopic ultrasound (EUS) fine needle aspiration. However, this recommendation is conditional and is backed by a very low level of evidence.

Other reports have shown varying risks at different growth rates. “It’s not really clear at this point. And that’s why I think, while our study is small and exploratory, this is a particular area that is relatively easy to evaluate. We have huge databases of pancreatic cyst evolution, and we know that 30 million Americans have diabetes. So, the next obvious study is to do a more systematic look at that, and work towards refining and making sense of these divergent guidelines, all of which are saying the same thing but using different threshold numbers,” said Dr. Robbins.

The next step is do larger, multicenter studies in the context of other risk factors such as family history and smoking, but the current finding represents an opportunity to catch at least some pancreatic cancers earlier, according to Dr. Robbins. He suggested that individuals with diabetes who are diagnosed with a pancreatic cyst should be referred to a gastroenterologist or another specialist to track cyst growth. “That is going to miss a lot of folks who didn’t get imaging for whatever reason (and so don’t have a cyst identified), but it is an early opportunity, and it’s better than what we’re doing now.”

During the talk, Dr. Robbins said, “Given the ease, availability and low cost of diabetes screening in the general clinic population, we encourage the inclusion of HbA1c and fasting glucose in algorithms for pancreatic cyst surveillance.”

Dr. Early found the suggestion intriguing, but wasn’t ready to lend full support. “I think looking at the suggestion of possibly monitoring hemoglobin A1c levels was novel. I don’t know that we’ll necessarily adopt that as standard practice, but that’s something I think that could be looked at in the future as a way to help risk stratify whether patients need to be surveyed more frequently,” she said.

Dr. Robbins and Dr. Early have no relevant financial disclosures.

LAS VEGAS – New results from a single center, retrospective analysis suggest that individuals with diabetes and pancreatic cysts have larger cyst sizes at diagnosis, and a faster subsequent cyst growth rate. Smoking was independently associated with faster growth rate.

iStock/ThinkStock

Most pancreatic cancer patients were previously diagnosed with hyperglycemia and diabetes, and pancreatic cancer can cause diabetes. “This sort of dual causality raises questions as to whether or not hyperglycemia, or the new diagnosis of diabetes itself, could be a harbinger of cancer or precancer. And should these patients be more closely monitored?” David Robbins, MD, said in an interview.

MDedge News

Dr. Robbins, associate professor of medicine and program director in gastroenterology in the Northwell Health System, New York, presented the study at the annual meeting of the American College of Gastroenterology.

Faster growth rates of pancreatic cysts in the presence of diabetes are important because they represent a potential mark for cyst aggressiveness. “So the question really is, in the setting of diabetes, are there factors perhaps circulating in the bloodstream, or other intrinsic factors, that make these cysts more dangerous and require a different surveillance approach than someone who doesn’t have diabetes? We have (surveillance) guidelines that address the average population, but they don’t really hone in on what do you do with (individuals with diabetes),” Dr. Robbins said during the presentation.

The study could have implications for screening, said session moderator Dayna Early, MD, professor of medicine at Washington University and director of endoscopy at Barnes Jewish Hospital, both in St. Louis. “I think this is important information to guide us to look more closely at patients with diabetes who do have pancreatic cysts,” she said in an interview.

The study included 177 adults with pancreatic cysts or abnormal imaging results between 2013 and 2020. Sixty-five percent were female, and the mean age was 65.4 years; 64% were White, 10% were Black, and 8.5% were Asian. Among the participants, 24.8% were smokers and 32.2% had type 2 diabetes.

Patients with diabetes had larger cyst sizes (2.23 cm versus 2.76 cm), as well as a higher annual cyst growth rate (1.90 cm versus 1.30 cm). Cyst size and growth rate were similar between patients with controlled and uncontrolled diabetes. Smoking was associated with a larger cyst size overall (2.2 cm versus 1.81 cm), and were larger still among patients with diabetes who smoked (2.35 cm).

Seventy-one patients went on to have pathologic confirmation by endoscopic ultrasound-guided fine needle aspiration. “In the diabetic group, two developed adenocarcinoma, six of the nondiabetics developed adenocarcinoma, and there was no difference in CEA or serum CA 19-9,” Dr. Robbins said during his presentation.

Of 28 patients diagnosed with pancreatic cancer, 13 had type 2 diabetes.
 

Defining danger

There remains uncertainty about what cyst growth rate is most dangerous. Some guidelines recommend that individuals with new-onset or worsening diabetes and intraductal papillary mucinous neoplasm or mucinous cystic neoplasm cysts, or cysts alone that are growing faster than 3 mm per year, may be at significantly increased risk of pancreatic cancer. These guidelines recommend that they be screened with short-interval magnetic resonance imaging or endoscopic ultrasound (EUS) fine needle aspiration. However, this recommendation is conditional and is backed by a very low level of evidence.

Other reports have shown varying risks at different growth rates. “It’s not really clear at this point. And that’s why I think, while our study is small and exploratory, this is a particular area that is relatively easy to evaluate. We have huge databases of pancreatic cyst evolution, and we know that 30 million Americans have diabetes. So, the next obvious study is to do a more systematic look at that, and work towards refining and making sense of these divergent guidelines, all of which are saying the same thing but using different threshold numbers,” said Dr. Robbins.

The next step is do larger, multicenter studies in the context of other risk factors such as family history and smoking, but the current finding represents an opportunity to catch at least some pancreatic cancers earlier, according to Dr. Robbins. He suggested that individuals with diabetes who are diagnosed with a pancreatic cyst should be referred to a gastroenterologist or another specialist to track cyst growth. “That is going to miss a lot of folks who didn’t get imaging for whatever reason (and so don’t have a cyst identified), but it is an early opportunity, and it’s better than what we’re doing now.”

During the talk, Dr. Robbins said, “Given the ease, availability and low cost of diabetes screening in the general clinic population, we encourage the inclusion of HbA1c and fasting glucose in algorithms for pancreatic cyst surveillance.”

Dr. Early found the suggestion intriguing, but wasn’t ready to lend full support. “I think looking at the suggestion of possibly monitoring hemoglobin A1c levels was novel. I don’t know that we’ll necessarily adopt that as standard practice, but that’s something I think that could be looked at in the future as a way to help risk stratify whether patients need to be surveyed more frequently,” she said.

Dr. Robbins and Dr. Early have no relevant financial disclosures.

In May 2016, Tarrah Oliver had been working as a bench tech in hematology at Tséhootsooí Medical Center (TMC) for 4 years when the hospital launched a 5-point screen for detecting hantavirus cardiopulmonary syndrome (HCPS), a potentially fatal disease that disproportionately affects Native Americans.

Developed at the University of New Mexico, the 5-point screen was particularly useful for facilities like TMC, a 56-bed hospital in Arizona serving Navajo Nation patients. Although the Navajo make up only 1.7% of the population, they account for 18% of all reported HCPS cases in the US.

But Oliver, who was the laboratory Safety and Training supervisor, her department supervisor, and his assistant were the only people who knew how to do the screen. “I was storing completed worksheets in a folder,” Oliver said, “and soon I had to transfer them to a 3-inch binder because we had so many being ordered. I started saving slides that scored high so that I could show my fellow lab mates what certain characteristics looked like under the microscope.” She also created case studies to train staff using analyzer printouts and slides from the patients. “It was my little side project to take care of while I was working and training new employees in the hematology department.”

The screen was to become much more than a side project very quickly.

In 2017, there was a hantavirus outbreak in one of the nearby communities. A team from the Centers for Disease Control and Prevention (CDC) came out to visit the local hospitals to educate the medical staff on what to look for in their patients with suspected hantavirus. Among those: the TMC staff. The visit would prove both serendipitous and synergistic.

Mary Choi, MD, MPH, medical officer with the CDC Viral Special Pathogens Branch, said, “Members of my branch were asked to come to Navajo Nation [Lukachukai chapter, Arizona] because of a cluster of hantaviruses cases that had been occurring in the area over the course of a few years. During a meeting with medical providers at TMC, our team met Tarrah and she told us that TMC had implemented the screen. We were really intrigued and impressed by the initiative of this small community hospital.”

“We were excited that the CDC even knew we existed!” Oliver recalled. “This little lab in the middle of the reservation.”

HCPS is rare but severe. It can quickly progress from nonspecific initial symptoms, such as fever, body aches, and shortness of breath, to severe respiratory distress. Without immediate intervention, patients usually die within 24 to 48 hours of the onset of cardiopulmonary symptoms. “What makes the disease even more challenging,” said Choi, “is that some of the critical lifesaving measures that physicians normally employ to save a critically-ill patient can actually make the situation worse.

“For example, when HCPS patients reach the cardiopulmonary phase of the illness, their blood pressure will drop. The normal response to this is to give IV fluids (IVF). But in hantavirus, giving IVF can actually make the signs and symptoms of the disease worse and only judicious use of IVF is recommended.”

She gave other examples of treatment challenges: “Physicians are taught to intubate critically ill patients. However, intubation of hanta patients during the cardiopulmonary phase can actually be detrimental. Also, in general, extracorporeal membrane oxygenation (ECMO) is an intervention of last resort for most critically-ill patients. As the procedure essentially involves hooking the patient up to a heart-lung machine, which has a lot of complications, doctors do not do this unless they have to. But in hantavirus disease, early initiation of ECMO has been shown to significantly improve survival.”

“Another tricky thing about ECMO is that not all hospitals have an ECMO machine… oftentimes patients have to be transferred from one hospital to another because they need ECMO and it is not available where they are.” The ECMO-equipped facility closest to TMC is 170 miles away, at the University of New Mexico Hospital in Albuquerque.

 For all those reasons, Dr. Choi said, it is critically important for physicians to know if the patient they are treating has hantavirus or not. The problem is, there is no rapid test for hantavirus disease. The tests have to be sent out to a laboratory and it can take days before physicians receive a test result. “This is where the 5-point screen is such a valuable tool. Although it is not a diagnostic test, it is a very accurate screening tool. Even better, it is readily and widely available, because to perform the screen, you only need a complete blood count (CBC) and a peripheral blood smear…which can be performed in the vast majority of laboratories and clinics. In addition, the CBC and peripheral blood smear are very commonly ordered tests.”

The screen could be particularly crucial for small community hospitals and clinics. “[TMC] took a screen developed by hematopathologists for hematopathologists,” Choi said, “and adapted it so that it could be performed by clinical laboratorians—because hematopathologists don’t exactly grow on trees! Once we heard about the work that TMC was doing, we knew that this was something we wanted to support and advocate for.”

“We started to throw around the idea of teaching this method to other laboratories on the reservation,” Oliver said. She and Mary Choi teamed up to “knock on everyone’s door to see who was utilizing the screening or if they had their own methods of detecting hantavirus in their patients.”

Two years later, they began holding training sessions at a nearby community college; they also trained an entire laboratory at their hospital in late 2019. Plans were to set up other training sessions towards the border towns before spring of 2020.

Then SARS-CoV-2 showed up.

Hantavirus or coronavirus?

COVID-19 hit the Navajo Nation like a sledgehammer. Native Americans in rural areas, as many Navajo are, may have multigenerational and extended families living in tight quarters, with limited access to running water, miles from the nearest healthcare facility. They were particularly vulnerable to a virus that thrives on close contact, at a time when the most common preventives were distancing, frequent handwashing, and testing. By May 2020, the Navajo Nation had surpassed the epicenters—New York and New Jersey—in cases of infection. Even as late as November 2021, the Navah Nation has reported > 37,000 positive cases, and nearly 1,500 confirmed deaths, despite reaching a 70% vaccination rate.

Making things ever more challenging: How do you know whether the patient has hantavirus or COVID-19? The distinction is critical because the disease courses of the 2 infections differ greatly. “The importance of [TMC’s] work was really brought home by the COVID pandemic,” Mary Choi said. “The signs and symptoms of early COVID and hantavirus are really indistinguishable. But the problem is that most people with COVID will live, while most people with hantavirus will die without critical care.”

The overall US case fatality rates are drastically different: 36% to 38% for hantavirus, 1.6% for COVID-19. In Arizona alone, of 81 patients who developed hantavirus (as of 2019), 27 died. In New Mexico, of 117 patients, 51 died.

“The scary part,” said Tarrah Oliver, “was that when patients were flooding our ER with symptoms exactly like those of hantavirus, I kept thinking that it was now up to us in the lab to scrutinize CBC results for any characteristics of hantavirus because our locum providers and permanent providers would likely not have hanta on their minds right now to suspect it.”

“Once COVID hit Navajo Nation, we really worried about how clinicians were going to distinguish between the two disease entities and worried about possible excess deaths of hanta because they were mistaken for COVID-19,” Choi says. “Unfortunately, in the spring of 2020, 2 fatal cases of hantavirus were reported. Their deaths were initially thought to be due to COVID, but later testing showed that they both died of hantavirus. We knew that we had to study whether the 5-point screen could distinguish between hantavirus disease and COVID.”

They conducted the comparison study at TMC and Emory, in Atlanta. TMC, as a small hospital, might not get many COVID cases while Emory, a large hospital system, had many COVID cases but rarely hantavirus cases (Box).

The researchers found that the screen did indeed work as they had hoped. No matter who performed the screen, the demographics of the population screened, or when in the COVID-19 disease course the sample was taken, individuals positive for COVID-19 received a low score on the screen. None of the participants who were positive for COVID-19 demonstrated all 5 hallmarks of hantavirus infection, and only 3 patients received a score of 4.

The screen was most accurate when the specimen was collected during the cardiopulmonary phase. Before the cardiopulmonary phase [BOX], there is a short febrile prodromal phase in which the platelets are starting to drop but aren’t low enough to be considered thrombocytopenic. Hematocrit and hemoglobin levels are still normal, and immunoblasts or plasma cells haven’t been released into the blood yet. “A patient’s score is likely to be pretty low or intermediate,” Tarrah Oliver said. “In the febrile prodromal phase, the patient will have chills, fever, headache and myalgia lasting 3 to 6 days, which might be written off as the flu or even COVID-19, especially if a provider is not familiar with the endemic regions of the Navajo Nation.”

“When we found that the screen could distinguish between the 2 diseases,” Choi said, “we worked frantically to write up the findings and publish so that healthcare providers would be aware of the value of this tool.”

“I couldn’t be more excited that the word is getting out in the medical community,” Oliver said. They plan to share the information as widely as possible, booking local radio spots, for instance. “We’re trying to disseminate our research across our partners on the reservation.”

The results of the research were recently published in the American Journal of Clinical Pathology. “Our next follow-up research will be an inter-rater reliability between TMC’s 2-year and 4-year-degree medical laboratorians and Emory’s pathologists performing the 5-point hantavirus screen on the same slides. We want to show that rural hospitals without the expertise of pathologists can perform this screen for their patients in a timely manner and still get the same outcomes.”

Lastly, and the most exciting, Oliver said, is putting that training manual she created to wider use. In addition to all the case studies she collected, analyzer printouts, and PowerPoint slides about the epidemiology, the manual includes a procedure, billing codes, and layout of what it looks like on certain medical record software that most Indian Health Service hospitals use. “With the manual, we may be able to expand our reach, so I won’t need to travel,” Oliver said. “We could use Zoom to reach further and I could explain it all while they have the manual right in front them.”

So far, nearly 200 screens have been performed at TMC. Four cases of hantavirus disease have been identified. The screen has proved successful, but for Oliver, there’s a personal reward. “I heard stories as a kid of relatives and friends succumbing to this mystery flu in the 1990s and how our parents protected us from it,” she said. “Now I feel like it’s my turn to take care of my family and friends from both hantavirus and COVID, our current ‘mystery flu.’ … I’ve realized that now I’m doing this for our people, the Diné (Navajo) people.”

This article offers some background and follow-up to Hantavirus Disease and COVID-19: Evaluation of the Hantavirus 5-Point Screen in 139 COVID-19 Patients

In May 2016, Tarrah Oliver had been working as a bench tech in hematology at Tséhootsooí Medical Center (TMC) for 4 years when the hospital launched a 5-point screen for detecting hantavirus cardiopulmonary syndrome (HCPS), a potentially fatal disease that disproportionately affects Native Americans.

Developed at the University of New Mexico, the 5-point screen was particularly useful for facilities like TMC, a 56-bed hospital in Arizona serving Navajo Nation patients. Although the Navajo make up only 1.7% of the population, they account for 18% of all reported HCPS cases in the US.

But Oliver, who was the laboratory Safety and Training supervisor, her department supervisor, and his assistant were the only people who knew how to do the screen. “I was storing completed worksheets in a folder,” Oliver said, “and soon I had to transfer them to a 3-inch binder because we had so many being ordered. I started saving slides that scored high so that I could show my fellow lab mates what certain characteristics looked like under the microscope.” She also created case studies to train staff using analyzer printouts and slides from the patients. “It was my little side project to take care of while I was working and training new employees in the hematology department.”

The screen was to become much more than a side project very quickly.

In 2017, there was a hantavirus outbreak in one of the nearby communities. A team from the Centers for Disease Control and Prevention (CDC) came out to visit the local hospitals to educate the medical staff on what to look for in their patients with suspected hantavirus. Among those: the TMC staff. The visit would prove both serendipitous and synergistic.

Mary Choi, MD, MPH, medical officer with the CDC Viral Special Pathogens Branch, said, “Members of my branch were asked to come to Navajo Nation [Lukachukai chapter, Arizona] because of a cluster of hantaviruses cases that had been occurring in the area over the course of a few years. During a meeting with medical providers at TMC, our team met Tarrah and she told us that TMC had implemented the screen. We were really intrigued and impressed by the initiative of this small community hospital.”

“We were excited that the CDC even knew we existed!” Oliver recalled. “This little lab in the middle of the reservation.”

HCPS is rare but severe. It can quickly progress from nonspecific initial symptoms, such as fever, body aches, and shortness of breath, to severe respiratory distress. Without immediate intervention, patients usually die within 24 to 48 hours of the onset of cardiopulmonary symptoms. “What makes the disease even more challenging,” said Choi, “is that some of the critical lifesaving measures that physicians normally employ to save a critically-ill patient can actually make the situation worse.

“For example, when HCPS patients reach the cardiopulmonary phase of the illness, their blood pressure will drop. The normal response to this is to give IV fluids (IVF). But in hantavirus, giving IVF can actually make the signs and symptoms of the disease worse and only judicious use of IVF is recommended.”

She gave other examples of treatment challenges: “Physicians are taught to intubate critically ill patients. However, intubation of hanta patients during the cardiopulmonary phase can actually be detrimental. Also, in general, extracorporeal membrane oxygenation (ECMO) is an intervention of last resort for most critically-ill patients. As the procedure essentially involves hooking the patient up to a heart-lung machine, which has a lot of complications, doctors do not do this unless they have to. But in hantavirus disease, early initiation of ECMO has been shown to significantly improve survival.”

“Another tricky thing about ECMO is that not all hospitals have an ECMO machine… oftentimes patients have to be transferred from one hospital to another because they need ECMO and it is not available where they are.” The ECMO-equipped facility closest to TMC is 170 miles away, at the University of New Mexico Hospital in Albuquerque.

 For all those reasons, Dr. Choi said, it is critically important for physicians to know if the patient they are treating has hantavirus or not. The problem is, there is no rapid test for hantavirus disease. The tests have to be sent out to a laboratory and it can take days before physicians receive a test result. “This is where the 5-point screen is such a valuable tool. Although it is not a diagnostic test, it is a very accurate screening tool. Even better, it is readily and widely available, because to perform the screen, you only need a complete blood count (CBC) and a peripheral blood smear…which can be performed in the vast majority of laboratories and clinics. In addition, the CBC and peripheral blood smear are very commonly ordered tests.”

The screen could be particularly crucial for small community hospitals and clinics. “[TMC] took a screen developed by hematopathologists for hematopathologists,” Choi said, “and adapted it so that it could be performed by clinical laboratorians—because hematopathologists don’t exactly grow on trees! Once we heard about the work that TMC was doing, we knew that this was something we wanted to support and advocate for.”

“We started to throw around the idea of teaching this method to other laboratories on the reservation,” Oliver said. She and Mary Choi teamed up to “knock on everyone’s door to see who was utilizing the screening or if they had their own methods of detecting hantavirus in their patients.”

Two years later, they began holding training sessions at a nearby community college; they also trained an entire laboratory at their hospital in late 2019. Plans were to set up other training sessions towards the border towns before spring of 2020.

Then SARS-CoV-2 showed up.

Hantavirus or coronavirus?

COVID-19 hit the Navajo Nation like a sledgehammer. Native Americans in rural areas, as many Navajo are, may have multigenerational and extended families living in tight quarters, with limited access to running water, miles from the nearest healthcare facility. They were particularly vulnerable to a virus that thrives on close contact, at a time when the most common preventives were distancing, frequent handwashing, and testing. By May 2020, the Navajo Nation had surpassed the epicenters—New York and New Jersey—in cases of infection. Even as late as November 2021, the Navah Nation has reported > 37,000 positive cases, and nearly 1,500 confirmed deaths, despite reaching a 70% vaccination rate.

Making things ever more challenging: How do you know whether the patient has hantavirus or COVID-19? The distinction is critical because the disease courses of the 2 infections differ greatly. “The importance of [TMC’s] work was really brought home by the COVID pandemic,” Mary Choi said. “The signs and symptoms of early COVID and hantavirus are really indistinguishable. But the problem is that most people with COVID will live, while most people with hantavirus will die without critical care.”

The overall US case fatality rates are drastically different: 36% to 38% for hantavirus, 1.6% for COVID-19. In Arizona alone, of 81 patients who developed hantavirus (as of 2019), 27 died. In New Mexico, of 117 patients, 51 died.

“The scary part,” said Tarrah Oliver, “was that when patients were flooding our ER with symptoms exactly like those of hantavirus, I kept thinking that it was now up to us in the lab to scrutinize CBC results for any characteristics of hantavirus because our locum providers and permanent providers would likely not have hanta on their minds right now to suspect it.”

“Once COVID hit Navajo Nation, we really worried about how clinicians were going to distinguish between the two disease entities and worried about possible excess deaths of hanta because they were mistaken for COVID-19,” Choi says. “Unfortunately, in the spring of 2020, 2 fatal cases of hantavirus were reported. Their deaths were initially thought to be due to COVID, but later testing showed that they both died of hantavirus. We knew that we had to study whether the 5-point screen could distinguish between hantavirus disease and COVID.”

They conducted the comparison study at TMC and Emory, in Atlanta. TMC, as a small hospital, might not get many COVID cases while Emory, a large hospital system, had many COVID cases but rarely hantavirus cases (Box).

The researchers found that the screen did indeed work as they had hoped. No matter who performed the screen, the demographics of the population screened, or when in the COVID-19 disease course the sample was taken, individuals positive for COVID-19 received a low score on the screen. None of the participants who were positive for COVID-19 demonstrated all 5 hallmarks of hantavirus infection, and only 3 patients received a score of 4.

The screen was most accurate when the specimen was collected during the cardiopulmonary phase. Before the cardiopulmonary phase [BOX], there is a short febrile prodromal phase in which the platelets are starting to drop but aren’t low enough to be considered thrombocytopenic. Hematocrit and hemoglobin levels are still normal, and immunoblasts or plasma cells haven’t been released into the blood yet. “A patient’s score is likely to be pretty low or intermediate,” Tarrah Oliver said. “In the febrile prodromal phase, the patient will have chills, fever, headache and myalgia lasting 3 to 6 days, which might be written off as the flu or even COVID-19, especially if a provider is not familiar with the endemic regions of the Navajo Nation.”

“When we found that the screen could distinguish between the 2 diseases,” Choi said, “we worked frantically to write up the findings and publish so that healthcare providers would be aware of the value of this tool.”

“I couldn’t be more excited that the word is getting out in the medical community,” Oliver said. They plan to share the information as widely as possible, booking local radio spots, for instance. “We’re trying to disseminate our research across our partners on the reservation.”

The results of the research were recently published in the American Journal of Clinical Pathology. “Our next follow-up research will be an inter-rater reliability between TMC’s 2-year and 4-year-degree medical laboratorians and Emory’s pathologists performing the 5-point hantavirus screen on the same slides. We want to show that rural hospitals without the expertise of pathologists can perform this screen for their patients in a timely manner and still get the same outcomes.”

Lastly, and the most exciting, Oliver said, is putting that training manual she created to wider use. In addition to all the case studies she collected, analyzer printouts, and PowerPoint slides about the epidemiology, the manual includes a procedure, billing codes, and layout of what it looks like on certain medical record software that most Indian Health Service hospitals use. “With the manual, we may be able to expand our reach, so I won’t need to travel,” Oliver said. “We could use Zoom to reach further and I could explain it all while they have the manual right in front them.”

So far, nearly 200 screens have been performed at TMC. Four cases of hantavirus disease have been identified. The screen has proved successful, but for Oliver, there’s a personal reward. “I heard stories as a kid of relatives and friends succumbing to this mystery flu in the 1990s and how our parents protected us from it,” she said. “Now I feel like it’s my turn to take care of my family and friends from both hantavirus and COVID, our current ‘mystery flu.’ … I’ve realized that now I’m doing this for our people, the Diné (Navajo) people.”

This article offers some background and follow-up to Hantavirus Disease and COVID-19: Evaluation of the Hantavirus 5-Point Screen in 139 COVID-19 Patients

In May 2016, Tarrah Oliver had been working as a bench tech in hematology at Tséhootsooí Medical Center (TMC) for 4 years when the hospital launched a 5-point screen for detecting hantavirus cardiopulmonary syndrome (HCPS), a potentially fatal disease that disproportionately affects Native Americans.

Developed at the University of New Mexico, the 5-point screen was particularly useful for facilities like TMC, a 56-bed hospital in Arizona serving Navajo Nation patients. Although the Navajo make up only 1.7% of the population, they account for 18% of all reported HCPS cases in the US.

But Oliver, who was the laboratory Safety and Training supervisor, her department supervisor, and his assistant were the only people who knew how to do the screen. “I was storing completed worksheets in a folder,” Oliver said, “and soon I had to transfer them to a 3-inch binder because we had so many being ordered. I started saving slides that scored high so that I could show my fellow lab mates what certain characteristics looked like under the microscope.” She also created case studies to train staff using analyzer printouts and slides from the patients. “It was my little side project to take care of while I was working and training new employees in the hematology department.”

The screen was to become much more than a side project very quickly.

In 2017, there was a hantavirus outbreak in one of the nearby communities. A team from the Centers for Disease Control and Prevention (CDC) came out to visit the local hospitals to educate the medical staff on what to look for in their patients with suspected hantavirus. Among those: the TMC staff. The visit would prove both serendipitous and synergistic.

Mary Choi, MD, MPH, medical officer with the CDC Viral Special Pathogens Branch, said, “Members of my branch were asked to come to Navajo Nation [Lukachukai chapter, Arizona] because of a cluster of hantaviruses cases that had been occurring in the area over the course of a few years. During a meeting with medical providers at TMC, our team met Tarrah and she told us that TMC had implemented the screen. We were really intrigued and impressed by the initiative of this small community hospital.”

“We were excited that the CDC even knew we existed!” Oliver recalled. “This little lab in the middle of the reservation.”

HCPS is rare but severe. It can quickly progress from nonspecific initial symptoms, such as fever, body aches, and shortness of breath, to severe respiratory distress. Without immediate intervention, patients usually die within 24 to 48 hours of the onset of cardiopulmonary symptoms. “What makes the disease even more challenging,” said Choi, “is that some of the critical lifesaving measures that physicians normally employ to save a critically-ill patient can actually make the situation worse.

“For example, when HCPS patients reach the cardiopulmonary phase of the illness, their blood pressure will drop. The normal response to this is to give IV fluids (IVF). But in hantavirus, giving IVF can actually make the signs and symptoms of the disease worse and only judicious use of IVF is recommended.”

She gave other examples of treatment challenges: “Physicians are taught to intubate critically ill patients. However, intubation of hanta patients during the cardiopulmonary phase can actually be detrimental. Also, in general, extracorporeal membrane oxygenation (ECMO) is an intervention of last resort for most critically-ill patients. As the procedure essentially involves hooking the patient up to a heart-lung machine, which has a lot of complications, doctors do not do this unless they have to. But in hantavirus disease, early initiation of ECMO has been shown to significantly improve survival.”

“Another tricky thing about ECMO is that not all hospitals have an ECMO machine… oftentimes patients have to be transferred from one hospital to another because they need ECMO and it is not available where they are.” The ECMO-equipped facility closest to TMC is 170 miles away, at the University of New Mexico Hospital in Albuquerque.

 For all those reasons, Dr. Choi said, it is critically important for physicians to know if the patient they are treating has hantavirus or not. The problem is, there is no rapid test for hantavirus disease. The tests have to be sent out to a laboratory and it can take days before physicians receive a test result. “This is where the 5-point screen is such a valuable tool. Although it is not a diagnostic test, it is a very accurate screening tool. Even better, it is readily and widely available, because to perform the screen, you only need a complete blood count (CBC) and a peripheral blood smear…which can be performed in the vast majority of laboratories and clinics. In addition, the CBC and peripheral blood smear are very commonly ordered tests.”

The screen could be particularly crucial for small community hospitals and clinics. “[TMC] took a screen developed by hematopathologists for hematopathologists,” Choi said, “and adapted it so that it could be performed by clinical laboratorians—because hematopathologists don’t exactly grow on trees! Once we heard about the work that TMC was doing, we knew that this was something we wanted to support and advocate for.”

“We started to throw around the idea of teaching this method to other laboratories on the reservation,” Oliver said. She and Mary Choi teamed up to “knock on everyone’s door to see who was utilizing the screening or if they had their own methods of detecting hantavirus in their patients.”

Two years later, they began holding training sessions at a nearby community college; they also trained an entire laboratory at their hospital in late 2019. Plans were to set up other training sessions towards the border towns before spring of 2020.

Then SARS-CoV-2 showed up.

Hantavirus or coronavirus?

COVID-19 hit the Navajo Nation like a sledgehammer. Native Americans in rural areas, as many Navajo are, may have multigenerational and extended families living in tight quarters, with limited access to running water, miles from the nearest healthcare facility. They were particularly vulnerable to a virus that thrives on close contact, at a time when the most common preventives were distancing, frequent handwashing, and testing. By May 2020, the Navajo Nation had surpassed the epicenters—New York and New Jersey—in cases of infection. Even as late as November 2021, the Navah Nation has reported > 37,000 positive cases, and nearly 1,500 confirmed deaths, despite reaching a 70% vaccination rate.

Making things ever more challenging: How do you know whether the patient has hantavirus or COVID-19? The distinction is critical because the disease courses of the 2 infections differ greatly. “The importance of [TMC’s] work was really brought home by the COVID pandemic,” Mary Choi said. “The signs and symptoms of early COVID and hantavirus are really indistinguishable. But the problem is that most people with COVID will live, while most people with hantavirus will die without critical care.”

The overall US case fatality rates are drastically different: 36% to 38% for hantavirus, 1.6% for COVID-19. In Arizona alone, of 81 patients who developed hantavirus (as of 2019), 27 died. In New Mexico, of 117 patients, 51 died.

“The scary part,” said Tarrah Oliver, “was that when patients were flooding our ER with symptoms exactly like those of hantavirus, I kept thinking that it was now up to us in the lab to scrutinize CBC results for any characteristics of hantavirus because our locum providers and permanent providers would likely not have hanta on their minds right now to suspect it.”

“Once COVID hit Navajo Nation, we really worried about how clinicians were going to distinguish between the two disease entities and worried about possible excess deaths of hanta because they were mistaken for COVID-19,” Choi says. “Unfortunately, in the spring of 2020, 2 fatal cases of hantavirus were reported. Their deaths were initially thought to be due to COVID, but later testing showed that they both died of hantavirus. We knew that we had to study whether the 5-point screen could distinguish between hantavirus disease and COVID.”

They conducted the comparison study at TMC and Emory, in Atlanta. TMC, as a small hospital, might not get many COVID cases while Emory, a large hospital system, had many COVID cases but rarely hantavirus cases (Box).

The researchers found that the screen did indeed work as they had hoped. No matter who performed the screen, the demographics of the population screened, or when in the COVID-19 disease course the sample was taken, individuals positive for COVID-19 received a low score on the screen. None of the participants who were positive for COVID-19 demonstrated all 5 hallmarks of hantavirus infection, and only 3 patients received a score of 4.

The screen was most accurate when the specimen was collected during the cardiopulmonary phase. Before the cardiopulmonary phase [BOX], there is a short febrile prodromal phase in which the platelets are starting to drop but aren’t low enough to be considered thrombocytopenic. Hematocrit and hemoglobin levels are still normal, and immunoblasts or plasma cells haven’t been released into the blood yet. “A patient’s score is likely to be pretty low or intermediate,” Tarrah Oliver said. “In the febrile prodromal phase, the patient will have chills, fever, headache and myalgia lasting 3 to 6 days, which might be written off as the flu or even COVID-19, especially if a provider is not familiar with the endemic regions of the Navajo Nation.”

“When we found that the screen could distinguish between the 2 diseases,” Choi said, “we worked frantically to write up the findings and publish so that healthcare providers would be aware of the value of this tool.”

“I couldn’t be more excited that the word is getting out in the medical community,” Oliver said. They plan to share the information as widely as possible, booking local radio spots, for instance. “We’re trying to disseminate our research across our partners on the reservation.”

The results of the research were recently published in the American Journal of Clinical Pathology. “Our next follow-up research will be an inter-rater reliability between TMC’s 2-year and 4-year-degree medical laboratorians and Emory’s pathologists performing the 5-point hantavirus screen on the same slides. We want to show that rural hospitals without the expertise of pathologists can perform this screen for their patients in a timely manner and still get the same outcomes.”

Lastly, and the most exciting, Oliver said, is putting that training manual she created to wider use. In addition to all the case studies she collected, analyzer printouts, and PowerPoint slides about the epidemiology, the manual includes a procedure, billing codes, and layout of what it looks like on certain medical record software that most Indian Health Service hospitals use. “With the manual, we may be able to expand our reach, so I won’t need to travel,” Oliver said. “We could use Zoom to reach further and I could explain it all while they have the manual right in front them.”

So far, nearly 200 screens have been performed at TMC. Four cases of hantavirus disease have been identified. The screen has proved successful, but for Oliver, there’s a personal reward. “I heard stories as a kid of relatives and friends succumbing to this mystery flu in the 1990s and how our parents protected us from it,” she said. “Now I feel like it’s my turn to take care of my family and friends from both hantavirus and COVID, our current ‘mystery flu.’ … I’ve realized that now I’m doing this for our people, the Diné (Navajo) people.”

This article offers some background and follow-up to Hantavirus Disease and COVID-19: Evaluation of the Hantavirus 5-Point Screen in 139 COVID-19 Patients

People with paroxysmal atrial fibrillation who explored potential triggers of their arrhythmia, and used them to make lifestyle changes, went on to show a 40% decline in subjectively experienced bouts of AFib in a randomized trial with an unusual design.

American Heart Association

But the study didn’t provide evidence that the drop in self-reported AFib necessarily improved their quality of life, its primary endpoint. Nor was there any apparent relationship between potential triggers and AFib episodes detected less subjectively using a handheld electrocardiography monitor.

Although the study – called I-STOP-AFib – has limitations, its results jibe with alcohol intake’s increasingly appreciated status as a potential AFib trigger. It was alone among many possible triggers tested in showing a consistent association with self-reported AFib.

As a result, the study offers no support for such a link between the arrhythmia and caffeine intake, sleep deprivation, dehydration, exercise, or other conditions sometimes perceived as triggers, observed principal investigator Gregory M. Marcus, MD, MAS, University of California, San Francisco, when presenting results at the American Heart Association scientific sessions. He is also lead author on the study’s simultaneous publication in JAMA Cardiology.

The I-STOP-AFib trial was unusual in part for its virtual design, in which participants followed instructions and tracked AFib episodes – both perceived and detected by the handheld ECG device – through a smartphone application. It also featured an N-of-1 randomized comparisons of different weeks in which individuals were or were not exposed to their self-selected trigger.

Such patients following their own weekly personalized randomization were compared to an entirely separate randomized control arm of the trial, in which patients simply tracked any ECG-monitored and self-perceived AFib episodes.
 

Current use in patients

Although wearable and smartphone-based ECG recorders are increasingly popular for AFib screening, Dr. Marcus said the devices may be especially helpful for validating whether a person’s symptoms are actually caused by AFib.

“I have actually suggested to some of my patients that they run some of these experiments,” he said at a media briefing on I-STOP-AFib before his main presentation of the trial. The demonstration might help patients recognize that some perceived triggers actually do not induce AFib.

Allowing patients to determine on their own whether a substance indeed triggers their AFib “is an efficient use of these devices,” Dr. Marcus said. Such N-of-1 exploration of possible triggers “might help free patients up to enjoy substances – caffeine or coffee is one example – that they otherwise might not, and may help actually reassure them that certain exposures –like certain exercises, which can also be beneficial – might actually not be harmful.”

Dr. Marcus and the other authors on the report noted – as he did at the AHA sessions – that the study has several limitations, such as the subjectivity of self-reported AFib, dropouts from the trial that shrank the randomization arms, and a population that may not be very representative.

There is also the potential for detection bias in the group assigned to track their selected triggers, as Dr. Marcus and some observers have noted.

It follows that conscious avoidance of a potential AFib trigger might well lead to a reduction in AFib subjectively identified by symptoms, proposed David Conen, MD, MPH, Population Health Research Institute, McMaster University, Hamilton, Ont. But perhaps there would have been no reduction in AFib had it been objectively documented with the handheld ECG device, he said in an interview.

“If I were to redesign the study,” he said, “I think the primary endpoint should be confirmed atrial fibrillation, because we would have to show first that the specific trigger actually reduced objective AFib events before we then try to address the question whether reducing that trigger improves quality of life.”
 

Unrepresentative sample

The trial entered 446 overwhelmingly White and college-educated adults known to have symptomatic paroxysmal AFib who were “interested in testing a presumed AFib trigger they could readily introduce or withhold” and who owned a smartphone; the average age was 58 years, and 58% were men. The cohort was randomly assigned to the trigger-testing group or the control group, charged only with tracking their AFib.

Of the total, 320, or about 72%, completed the study; those who did not were mostly from the trigger-testing arm, leaving 136 in that group versus 184 patients in the control group.

Potential triggers that participants selected for tracking included, foremost, caffeine, alcohol, reduced sleep, and exercise, followed by lying on the left side, dehydration, large meals, and cold food or drink, the report noted.

Patients in the control group used the smartphone app and handheld ECG monitor (KardiaMobile, AliveCor) to document the duration and severity of AFib episodes daily and received data summary reports through the app weekly for 10 weeks. They then had the option to follow the trigger-testing protocol at least once.

Those in the trigger-testing group conducted their N-of-1 trials by exposing themselves to their chosen potential trigger during 3 separate weeks and avoiding the trigger during 3 other weeks, alternating each of the 6 weeks of trigger exposure or avoidance. They were instructed through the app to start the 6-week sequence with one or the other strategy randomly and to regularly track their AFib.

At the end of 6 weeks, each participant in the trigger-testing group had the opportunity to review their data for any potential trigger-AFib associations. They were then to use the next 4 weeks to enact lifestyle changes based on what they learned – as described in the report and on clinicaltrials.gov. They had the option of repeating the entire N-of-1 sequence at least one more time.

Participants in both the trigger-tracking and control arms were tested at baseline and at 10 weeks using the validated Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire.

AFEQT scores didn’t change significantly over the 10 weeks in either arm, nor were they significantly different in one arm, compared with the other.

On the other hand, patients in the trigger-tracking arm reported significantly fewer daily AFib episodes during the final 4-week period of lifestyle changes based on their N-of-1 trial results, compared to the monitoring-only control group’s final 4 weeks.

The adjusted relative risk in the trigger-tracking arm was 0.60 (95% confidence interval, 0.43-0.83; P < .001), the difference driven by patients who selected alcohol, dehydration, or exercise for their trigger, Dr. Marcus reported.

Only alcohol intake emerged consistently as a significant predictor of risk for self-reported AFib episodes in a series of meta-analyses conducted using all of the individual N-of-1 trials that provided per-protocol data. The odds ratio was 1.77 (95% CI, 1.20-2.69).

I-STOP-AFib explored an important subject “that has been understudied,” Dr. Conen said. “The trial has some limitations that the authors address themselves, but hopefully it opens the path to future studies that can build upon this experience.”

Dr. Marcus reported receiving personal fees and equity interest from InCarda Therapeutics; personal fees from Johnson & Johnson; and grants from Baylis Medical, Medtronic, the National Institutes of Health, the Patient-Centered Outcomes Research Institute, and the California Tobacco-Related Disease Research Program.

A version of this article first appeared on Medscape.com.

People with paroxysmal atrial fibrillation who explored potential triggers of their arrhythmia, and used them to make lifestyle changes, went on to show a 40% decline in subjectively experienced bouts of AFib in a randomized trial with an unusual design.

American Heart Association

But the study didn’t provide evidence that the drop in self-reported AFib necessarily improved their quality of life, its primary endpoint. Nor was there any apparent relationship between potential triggers and AFib episodes detected less subjectively using a handheld electrocardiography monitor.

Although the study – called I-STOP-AFib – has limitations, its results jibe with alcohol intake’s increasingly appreciated status as a potential AFib trigger. It was alone among many possible triggers tested in showing a consistent association with self-reported AFib.

As a result, the study offers no support for such a link between the arrhythmia and caffeine intake, sleep deprivation, dehydration, exercise, or other conditions sometimes perceived as triggers, observed principal investigator Gregory M. Marcus, MD, MAS, University of California, San Francisco, when presenting results at the American Heart Association scientific sessions. He is also lead author on the study’s simultaneous publication in JAMA Cardiology.

The I-STOP-AFib trial was unusual in part for its virtual design, in which participants followed instructions and tracked AFib episodes – both perceived and detected by the handheld ECG device – through a smartphone application. It also featured an N-of-1 randomized comparisons of different weeks in which individuals were or were not exposed to their self-selected trigger.

Such patients following their own weekly personalized randomization were compared to an entirely separate randomized control arm of the trial, in which patients simply tracked any ECG-monitored and self-perceived AFib episodes.
 

Current use in patients

Although wearable and smartphone-based ECG recorders are increasingly popular for AFib screening, Dr. Marcus said the devices may be especially helpful for validating whether a person’s symptoms are actually caused by AFib.

“I have actually suggested to some of my patients that they run some of these experiments,” he said at a media briefing on I-STOP-AFib before his main presentation of the trial. The demonstration might help patients recognize that some perceived triggers actually do not induce AFib.

Allowing patients to determine on their own whether a substance indeed triggers their AFib “is an efficient use of these devices,” Dr. Marcus said. Such N-of-1 exploration of possible triggers “might help free patients up to enjoy substances – caffeine or coffee is one example – that they otherwise might not, and may help actually reassure them that certain exposures –like certain exercises, which can also be beneficial – might actually not be harmful.”

Dr. Marcus and the other authors on the report noted – as he did at the AHA sessions – that the study has several limitations, such as the subjectivity of self-reported AFib, dropouts from the trial that shrank the randomization arms, and a population that may not be very representative.

There is also the potential for detection bias in the group assigned to track their selected triggers, as Dr. Marcus and some observers have noted.

It follows that conscious avoidance of a potential AFib trigger might well lead to a reduction in AFib subjectively identified by symptoms, proposed David Conen, MD, MPH, Population Health Research Institute, McMaster University, Hamilton, Ont. But perhaps there would have been no reduction in AFib had it been objectively documented with the handheld ECG device, he said in an interview.

“If I were to redesign the study,” he said, “I think the primary endpoint should be confirmed atrial fibrillation, because we would have to show first that the specific trigger actually reduced objective AFib events before we then try to address the question whether reducing that trigger improves quality of life.”
 

Unrepresentative sample

The trial entered 446 overwhelmingly White and college-educated adults known to have symptomatic paroxysmal AFib who were “interested in testing a presumed AFib trigger they could readily introduce or withhold” and who owned a smartphone; the average age was 58 years, and 58% were men. The cohort was randomly assigned to the trigger-testing group or the control group, charged only with tracking their AFib.

Of the total, 320, or about 72%, completed the study; those who did not were mostly from the trigger-testing arm, leaving 136 in that group versus 184 patients in the control group.

Potential triggers that participants selected for tracking included, foremost, caffeine, alcohol, reduced sleep, and exercise, followed by lying on the left side, dehydration, large meals, and cold food or drink, the report noted.

Patients in the control group used the smartphone app and handheld ECG monitor (KardiaMobile, AliveCor) to document the duration and severity of AFib episodes daily and received data summary reports through the app weekly for 10 weeks. They then had the option to follow the trigger-testing protocol at least once.

Those in the trigger-testing group conducted their N-of-1 trials by exposing themselves to their chosen potential trigger during 3 separate weeks and avoiding the trigger during 3 other weeks, alternating each of the 6 weeks of trigger exposure or avoidance. They were instructed through the app to start the 6-week sequence with one or the other strategy randomly and to regularly track their AFib.

At the end of 6 weeks, each participant in the trigger-testing group had the opportunity to review their data for any potential trigger-AFib associations. They were then to use the next 4 weeks to enact lifestyle changes based on what they learned – as described in the report and on clinicaltrials.gov. They had the option of repeating the entire N-of-1 sequence at least one more time.

Participants in both the trigger-tracking and control arms were tested at baseline and at 10 weeks using the validated Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire.

AFEQT scores didn’t change significantly over the 10 weeks in either arm, nor were they significantly different in one arm, compared with the other.

On the other hand, patients in the trigger-tracking arm reported significantly fewer daily AFib episodes during the final 4-week period of lifestyle changes based on their N-of-1 trial results, compared to the monitoring-only control group’s final 4 weeks.

The adjusted relative risk in the trigger-tracking arm was 0.60 (95% confidence interval, 0.43-0.83; P < .001), the difference driven by patients who selected alcohol, dehydration, or exercise for their trigger, Dr. Marcus reported.

Only alcohol intake emerged consistently as a significant predictor of risk for self-reported AFib episodes in a series of meta-analyses conducted using all of the individual N-of-1 trials that provided per-protocol data. The odds ratio was 1.77 (95% CI, 1.20-2.69).

I-STOP-AFib explored an important subject “that has been understudied,” Dr. Conen said. “The trial has some limitations that the authors address themselves, but hopefully it opens the path to future studies that can build upon this experience.”

Dr. Marcus reported receiving personal fees and equity interest from InCarda Therapeutics; personal fees from Johnson & Johnson; and grants from Baylis Medical, Medtronic, the National Institutes of Health, the Patient-Centered Outcomes Research Institute, and the California Tobacco-Related Disease Research Program.

A version of this article first appeared on Medscape.com.

People with paroxysmal atrial fibrillation who explored potential triggers of their arrhythmia, and used them to make lifestyle changes, went on to show a 40% decline in subjectively experienced bouts of AFib in a randomized trial with an unusual design.

American Heart Association

But the study didn’t provide evidence that the drop in self-reported AFib necessarily improved their quality of life, its primary endpoint. Nor was there any apparent relationship between potential triggers and AFib episodes detected less subjectively using a handheld electrocardiography monitor.

Although the study – called I-STOP-AFib – has limitations, its results jibe with alcohol intake’s increasingly appreciated status as a potential AFib trigger. It was alone among many possible triggers tested in showing a consistent association with self-reported AFib.

As a result, the study offers no support for such a link between the arrhythmia and caffeine intake, sleep deprivation, dehydration, exercise, or other conditions sometimes perceived as triggers, observed principal investigator Gregory M. Marcus, MD, MAS, University of California, San Francisco, when presenting results at the American Heart Association scientific sessions. He is also lead author on the study’s simultaneous publication in JAMA Cardiology.

The I-STOP-AFib trial was unusual in part for its virtual design, in which participants followed instructions and tracked AFib episodes – both perceived and detected by the handheld ECG device – through a smartphone application. It also featured an N-of-1 randomized comparisons of different weeks in which individuals were or were not exposed to their self-selected trigger.

Such patients following their own weekly personalized randomization were compared to an entirely separate randomized control arm of the trial, in which patients simply tracked any ECG-monitored and self-perceived AFib episodes.
 

Current use in patients

Although wearable and smartphone-based ECG recorders are increasingly popular for AFib screening, Dr. Marcus said the devices may be especially helpful for validating whether a person’s symptoms are actually caused by AFib.

“I have actually suggested to some of my patients that they run some of these experiments,” he said at a media briefing on I-STOP-AFib before his main presentation of the trial. The demonstration might help patients recognize that some perceived triggers actually do not induce AFib.

Allowing patients to determine on their own whether a substance indeed triggers their AFib “is an efficient use of these devices,” Dr. Marcus said. Such N-of-1 exploration of possible triggers “might help free patients up to enjoy substances – caffeine or coffee is one example – that they otherwise might not, and may help actually reassure them that certain exposures –like certain exercises, which can also be beneficial – might actually not be harmful.”

Dr. Marcus and the other authors on the report noted – as he did at the AHA sessions – that the study has several limitations, such as the subjectivity of self-reported AFib, dropouts from the trial that shrank the randomization arms, and a population that may not be very representative.

There is also the potential for detection bias in the group assigned to track their selected triggers, as Dr. Marcus and some observers have noted.

It follows that conscious avoidance of a potential AFib trigger might well lead to a reduction in AFib subjectively identified by symptoms, proposed David Conen, MD, MPH, Population Health Research Institute, McMaster University, Hamilton, Ont. But perhaps there would have been no reduction in AFib had it been objectively documented with the handheld ECG device, he said in an interview.

“If I were to redesign the study,” he said, “I think the primary endpoint should be confirmed atrial fibrillation, because we would have to show first that the specific trigger actually reduced objective AFib events before we then try to address the question whether reducing that trigger improves quality of life.”
 

Unrepresentative sample

The trial entered 446 overwhelmingly White and college-educated adults known to have symptomatic paroxysmal AFib who were “interested in testing a presumed AFib trigger they could readily introduce or withhold” and who owned a smartphone; the average age was 58 years, and 58% were men. The cohort was randomly assigned to the trigger-testing group or the control group, charged only with tracking their AFib.

Of the total, 320, or about 72%, completed the study; those who did not were mostly from the trigger-testing arm, leaving 136 in that group versus 184 patients in the control group.

Potential triggers that participants selected for tracking included, foremost, caffeine, alcohol, reduced sleep, and exercise, followed by lying on the left side, dehydration, large meals, and cold food or drink, the report noted.

Patients in the control group used the smartphone app and handheld ECG monitor (KardiaMobile, AliveCor) to document the duration and severity of AFib episodes daily and received data summary reports through the app weekly for 10 weeks. They then had the option to follow the trigger-testing protocol at least once.

Those in the trigger-testing group conducted their N-of-1 trials by exposing themselves to their chosen potential trigger during 3 separate weeks and avoiding the trigger during 3 other weeks, alternating each of the 6 weeks of trigger exposure or avoidance. They were instructed through the app to start the 6-week sequence with one or the other strategy randomly and to regularly track their AFib.

At the end of 6 weeks, each participant in the trigger-testing group had the opportunity to review their data for any potential trigger-AFib associations. They were then to use the next 4 weeks to enact lifestyle changes based on what they learned – as described in the report and on clinicaltrials.gov. They had the option of repeating the entire N-of-1 sequence at least one more time.

Participants in both the trigger-tracking and control arms were tested at baseline and at 10 weeks using the validated Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire.

AFEQT scores didn’t change significantly over the 10 weeks in either arm, nor were they significantly different in one arm, compared with the other.

On the other hand, patients in the trigger-tracking arm reported significantly fewer daily AFib episodes during the final 4-week period of lifestyle changes based on their N-of-1 trial results, compared to the monitoring-only control group’s final 4 weeks.

The adjusted relative risk in the trigger-tracking arm was 0.60 (95% confidence interval, 0.43-0.83; P < .001), the difference driven by patients who selected alcohol, dehydration, or exercise for their trigger, Dr. Marcus reported.

Only alcohol intake emerged consistently as a significant predictor of risk for self-reported AFib episodes in a series of meta-analyses conducted using all of the individual N-of-1 trials that provided per-protocol data. The odds ratio was 1.77 (95% CI, 1.20-2.69).

I-STOP-AFib explored an important subject “that has been understudied,” Dr. Conen said. “The trial has some limitations that the authors address themselves, but hopefully it opens the path to future studies that can build upon this experience.”

Dr. Marcus reported receiving personal fees and equity interest from InCarda Therapeutics; personal fees from Johnson & Johnson; and grants from Baylis Medical, Medtronic, the National Institutes of Health, the Patient-Centered Outcomes Research Institute, and the California Tobacco-Related Disease Research Program.

A version of this article first appeared on Medscape.com.

On Nov. 12, president Joe Biden said he will nominate Robert Califf, MD, to be commissioner of the U.S. Food and Drug Administration, the top U.S. regulator of drugs and medical devices.

Dr. Califf, a cardiologist, served as FDA chief in the Obama administration, leading the agency from Feb. 2016 to Jan. 2017.

The coming nomination ends nearly 11 months of speculation over Mr. Biden’s pick to the lead the agency during the ongoing pandemic. Janet Woodcock, MD, an FDA veteran, has been serving as acting commissioner. The White House faced a Tuesday deadline to make a nomination or see Dr. Woodcock’s tenure as acting chief expire under federal law.

The initial reaction to the idea of Dr. Califf’s return to the FDA drew mixed reactions.

The nonprofit watchdog Public Citizen issued a statement about its opposition to the potential nomination of Dr. Califf. Michael Carome, MD, director of Public Citizen’s Health Research Group, said the United States “desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier – resulting in regulatory capture of the agency by industry.”

But the idea of Dr. Califf returning to the FDA pleased Harlan Krumholz, MD, a cardiologist who has been a leader in outcomes research.

Dr. Krumholz tweeted that the Biden administration likely was testing the reaction to a possible Dr. Califf nomination before making it official. “I realize that this is being floated and not officially announced ... but the nomination of [Califf] just makes so much sense,” Dr. Krumholz tweeted. Dr. Califf’s “expertise as a researcher, policymaker, clinician are unparalleled. In a time of partisanship, he should be a slam-dunk confirmation.”

Dr. Califf’s 2016 Senate confirmation process was marked by dissent from several Democrats who questioned his ties to industry. But the chamber voted 89-4 to confirm him.

A version of this article first appeared on Medscape.com.

On Nov. 12, president Joe Biden said he will nominate Robert Califf, MD, to be commissioner of the U.S. Food and Drug Administration, the top U.S. regulator of drugs and medical devices.

Dr. Califf, a cardiologist, served as FDA chief in the Obama administration, leading the agency from Feb. 2016 to Jan. 2017.

The coming nomination ends nearly 11 months of speculation over Mr. Biden’s pick to the lead the agency during the ongoing pandemic. Janet Woodcock, MD, an FDA veteran, has been serving as acting commissioner. The White House faced a Tuesday deadline to make a nomination or see Dr. Woodcock’s tenure as acting chief expire under federal law.

The initial reaction to the idea of Dr. Califf’s return to the FDA drew mixed reactions.

The nonprofit watchdog Public Citizen issued a statement about its opposition to the potential nomination of Dr. Califf. Michael Carome, MD, director of Public Citizen’s Health Research Group, said the United States “desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier – resulting in regulatory capture of the agency by industry.”

But the idea of Dr. Califf returning to the FDA pleased Harlan Krumholz, MD, a cardiologist who has been a leader in outcomes research.

Dr. Krumholz tweeted that the Biden administration likely was testing the reaction to a possible Dr. Califf nomination before making it official. “I realize that this is being floated and not officially announced ... but the nomination of [Califf] just makes so much sense,” Dr. Krumholz tweeted. Dr. Califf’s “expertise as a researcher, policymaker, clinician are unparalleled. In a time of partisanship, he should be a slam-dunk confirmation.”

Dr. Califf’s 2016 Senate confirmation process was marked by dissent from several Democrats who questioned his ties to industry. But the chamber voted 89-4 to confirm him.

A version of this article first appeared on Medscape.com.

On Nov. 12, president Joe Biden said he will nominate Robert Califf, MD, to be commissioner of the U.S. Food and Drug Administration, the top U.S. regulator of drugs and medical devices.

Dr. Califf, a cardiologist, served as FDA chief in the Obama administration, leading the agency from Feb. 2016 to Jan. 2017.

The coming nomination ends nearly 11 months of speculation over Mr. Biden’s pick to the lead the agency during the ongoing pandemic. Janet Woodcock, MD, an FDA veteran, has been serving as acting commissioner. The White House faced a Tuesday deadline to make a nomination or see Dr. Woodcock’s tenure as acting chief expire under federal law.

The initial reaction to the idea of Dr. Califf’s return to the FDA drew mixed reactions.

The nonprofit watchdog Public Citizen issued a statement about its opposition to the potential nomination of Dr. Califf. Michael Carome, MD, director of Public Citizen’s Health Research Group, said the United States “desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier – resulting in regulatory capture of the agency by industry.”

But the idea of Dr. Califf returning to the FDA pleased Harlan Krumholz, MD, a cardiologist who has been a leader in outcomes research.

Dr. Krumholz tweeted that the Biden administration likely was testing the reaction to a possible Dr. Califf nomination before making it official. “I realize that this is being floated and not officially announced ... but the nomination of [Califf] just makes so much sense,” Dr. Krumholz tweeted. Dr. Califf’s “expertise as a researcher, policymaker, clinician are unparalleled. In a time of partisanship, he should be a slam-dunk confirmation.”

Dr. Califf’s 2016 Senate confirmation process was marked by dissent from several Democrats who questioned his ties to industry. But the chamber voted 89-4 to confirm him.

A version of this article first appeared on Medscape.com.