A 10-year follow-up analysis based on one of cardiology’s most influential trials has shed further light on one of its key issues: how to sharpen selection of patients most likely to benefit from a primary prevention implantable cardioverter-defibrillator (ICD).

In a new report from SCD-HeFT, the survival advantage in patients with heart failure seen 5 years after receiving ICDs, compared with a non-ICD control group, narrowed a bit but remained significant after an additional 5 years. But not all patients with devices shared in that long-term ICD benefit. Patients with either ischemic disease or nonischemic cardiomyopathy (NICM) with devices showed a similar mortality risk reduction in the trial’s previously reported 5-year outcomes. That advantage, compared with non-ICD control patients, persisted throughout the subsequent 5 years for ischemic patients but tapered to nil for those with NICM.

The NICM patients “had what appears to be some accrual of benefit maybe out to about 6 years, and then the curves appear to come together where there’s no apparent further benefit after 6 years,” Jeanne E. Poole, MD, of the University of Washington, Seattle, said in an interview.

In both the 10-year analysis and the earlier results, ICD survival gains went preferentially to patients who enrolled with New York Heart Association (NYHA) functional class II symptoms. Patients who entered in NYHA class III “didn’t appear to have any benefit whatsoever” in either period, Dr. Poole said.

“The simple message is that the same groups of patients that benefited strongly from the ICD in the original SCD-HeFT – the NYHA class 2 patients and those with ischemic cardiomyopathy – were really the ones who benefited the greatest over the long term,” she said.

Dr. Poole is lead author on the SCD-HeFT 10-year analysis, which was published in the July 28 issue of the Journal of the American College of Cardiology.

Why the ICD survival effect disappeared midway in patients with NICM “is hard to sort out,” she said. Many in the control group were offered such devices after the trial concluded. Among those, it’s possible that disproportionately more control patients with NICM, compared with patients with ischemic disease, were fitted with ICDs that were also cardiac resynchronization therapy (CRT) devices, Dr. Poole and her colleagues speculated. That could have shifted their late outcomes to be more in line with patients who had received ICDs when the trial started.

Or “it is possible that the intermediate-term benefit of ICD therapy in NICM is overwhelmed by nonarrhythmic death in extended follow-up” given that ICDs prolong survival only by preventing arrhythmic death, noted an editorial accompanying the new SCD-HeFT publication.

Another possibility: Because NICM is a heterogeneous disorder with many potential causes, perhaps “the absence of long-term mortality benefit among SCD-HeFT participants with NICM was due to an unintended but preferential enrollment of subtypes at relatively lower risk for arrhythmic death in the longer term,” proposed Eric C. Stecker, MD, MPH, Oregon Health & Science University, Portland, and coauthors in their editorial.

“What are the take-away messages from the current analysis by Poole et al?” they asked. “These findings strongly support the clinical efficacy and cost-effectiveness of ICD therapy for the majority of patients with severe but mildly symptomatic ischemic cardiomyopathy who do not have an excessive comorbidity burden.”

But “the implications for patients with NICM are less clear,” they wrote. “Given evidence for intermediate-term benefit and the limitations inherent to assessing longer-term benefit, we do not believe it is appropriate to walk back guideline recommendations regarding ICD implantation for NICM patients.”

The findings in nonischemic patients invite comparison with the randomized DANISH trial, which entered only patients with NICM and, over more than 5 years, saw no primary-prevention ICD advantage for the end point of all-cause mortality.

But patients who received ICDs showed a reduction in arrhythmic death, a secondary end point. And mortality in the trial showed a significant interaction with patient age; survival went up sharply with ICDs for those younger than 60 years.

Also in DANISH, “the ICD treatment effect appears to vary over time, with an earlier phase showing possible survival benefit and a later phase showing attenuation of that benefit,” similar to what was seen long-term in SCD-HeFT, in which the interaction between mortality and time since implantation was significant at P = .0015, observe Dr. Poole and colleagues.

However, Dr. Poole cautioned when interviewed, patient management in DANISH, conducted exclusively in Denmark, may not have been representative of the rest of the world, complicating comparisons with other studies. For example, nearly 60% of all patients in DANISH had defibrillating CRT devices. Virtually everyone was on ACE inhibitors or angiotensin-receptor blockers, and almost 60% were taking aldosterone inhibitors.

“DANISH is an unusually high bar and probably does not reflect all patients with heart failure, and certainly does not reflect patients in the United States in terms of those high levels of guideline-directed medical therapy,” Dr. Poole said. The message from DANISH, she said, seems to be that patients with NICM who are definitely on goal-directed heart failure medications with CRT devices “probably don’t have a meaningful benefit from an ICD, on total mortality, because their sudden death rates are simply so low.”

SCD-HeFT had originally assigned 2,521 patients with heart failure of NYHA class II or III and an left ventricular ejection fraction of less than 35% to receive an ICD, amiodarone without an ICD, or an amiodarone placebo and no ICD; patients in the latter cohorts made up the non-ICD control group.

Those who received an ICD, compared with the non-ICD control patients, showed a 23% drop in all-cause mortality over a median of 45.5 months ending on October 31, 2003, Dr. Poole and colleagues noted in their current report. The trial’s primary results were unveiled 2005.

The current analysis, based on data collected in 2010 and 2011, followed the 1,855 patients alive at the trial’s official conclusion and combined outcomes before and after that time for a median follow-up of 11 years, Dr. Poole and colleagues reported.

In the ICD group, the overall hazard ratio for mortality by intention-to-treat was 0.87 (95% confidence interval, 0.76-0.98; P = .028), compared with the non-ICD control group.

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

A 10-year follow-up analysis based on one of cardiology’s most influential trials has shed further light on one of its key issues: how to sharpen selection of patients most likely to benefit from a primary prevention implantable cardioverter-defibrillator (ICD).

In a new report from SCD-HeFT, the survival advantage in patients with heart failure seen 5 years after receiving ICDs, compared with a non-ICD control group, narrowed a bit but remained significant after an additional 5 years. But not all patients with devices shared in that long-term ICD benefit. Patients with either ischemic disease or nonischemic cardiomyopathy (NICM) with devices showed a similar mortality risk reduction in the trial’s previously reported 5-year outcomes. That advantage, compared with non-ICD control patients, persisted throughout the subsequent 5 years for ischemic patients but tapered to nil for those with NICM.

The NICM patients “had what appears to be some accrual of benefit maybe out to about 6 years, and then the curves appear to come together where there’s no apparent further benefit after 6 years,” Jeanne E. Poole, MD, of the University of Washington, Seattle, said in an interview.

In both the 10-year analysis and the earlier results, ICD survival gains went preferentially to patients who enrolled with New York Heart Association (NYHA) functional class II symptoms. Patients who entered in NYHA class III “didn’t appear to have any benefit whatsoever” in either period, Dr. Poole said.

“The simple message is that the same groups of patients that benefited strongly from the ICD in the original SCD-HeFT – the NYHA class 2 patients and those with ischemic cardiomyopathy – were really the ones who benefited the greatest over the long term,” she said.

Dr. Poole is lead author on the SCD-HeFT 10-year analysis, which was published in the July 28 issue of the Journal of the American College of Cardiology.

Why the ICD survival effect disappeared midway in patients with NICM “is hard to sort out,” she said. Many in the control group were offered such devices after the trial concluded. Among those, it’s possible that disproportionately more control patients with NICM, compared with patients with ischemic disease, were fitted with ICDs that were also cardiac resynchronization therapy (CRT) devices, Dr. Poole and her colleagues speculated. That could have shifted their late outcomes to be more in line with patients who had received ICDs when the trial started.

Or “it is possible that the intermediate-term benefit of ICD therapy in NICM is overwhelmed by nonarrhythmic death in extended follow-up” given that ICDs prolong survival only by preventing arrhythmic death, noted an editorial accompanying the new SCD-HeFT publication.

Another possibility: Because NICM is a heterogeneous disorder with many potential causes, perhaps “the absence of long-term mortality benefit among SCD-HeFT participants with NICM was due to an unintended but preferential enrollment of subtypes at relatively lower risk for arrhythmic death in the longer term,” proposed Eric C. Stecker, MD, MPH, Oregon Health & Science University, Portland, and coauthors in their editorial.

“What are the take-away messages from the current analysis by Poole et al?” they asked. “These findings strongly support the clinical efficacy and cost-effectiveness of ICD therapy for the majority of patients with severe but mildly symptomatic ischemic cardiomyopathy who do not have an excessive comorbidity burden.”

But “the implications for patients with NICM are less clear,” they wrote. “Given evidence for intermediate-term benefit and the limitations inherent to assessing longer-term benefit, we do not believe it is appropriate to walk back guideline recommendations regarding ICD implantation for NICM patients.”

The findings in nonischemic patients invite comparison with the randomized DANISH trial, which entered only patients with NICM and, over more than 5 years, saw no primary-prevention ICD advantage for the end point of all-cause mortality.

But patients who received ICDs showed a reduction in arrhythmic death, a secondary end point. And mortality in the trial showed a significant interaction with patient age; survival went up sharply with ICDs for those younger than 60 years.

Also in DANISH, “the ICD treatment effect appears to vary over time, with an earlier phase showing possible survival benefit and a later phase showing attenuation of that benefit,” similar to what was seen long-term in SCD-HeFT, in which the interaction between mortality and time since implantation was significant at P = .0015, observe Dr. Poole and colleagues.

However, Dr. Poole cautioned when interviewed, patient management in DANISH, conducted exclusively in Denmark, may not have been representative of the rest of the world, complicating comparisons with other studies. For example, nearly 60% of all patients in DANISH had defibrillating CRT devices. Virtually everyone was on ACE inhibitors or angiotensin-receptor blockers, and almost 60% were taking aldosterone inhibitors.

“DANISH is an unusually high bar and probably does not reflect all patients with heart failure, and certainly does not reflect patients in the United States in terms of those high levels of guideline-directed medical therapy,” Dr. Poole said. The message from DANISH, she said, seems to be that patients with NICM who are definitely on goal-directed heart failure medications with CRT devices “probably don’t have a meaningful benefit from an ICD, on total mortality, because their sudden death rates are simply so low.”

SCD-HeFT had originally assigned 2,521 patients with heart failure of NYHA class II or III and an left ventricular ejection fraction of less than 35% to receive an ICD, amiodarone without an ICD, or an amiodarone placebo and no ICD; patients in the latter cohorts made up the non-ICD control group.

Those who received an ICD, compared with the non-ICD control patients, showed a 23% drop in all-cause mortality over a median of 45.5 months ending on October 31, 2003, Dr. Poole and colleagues noted in their current report. The trial’s primary results were unveiled 2005.

The current analysis, based on data collected in 2010 and 2011, followed the 1,855 patients alive at the trial’s official conclusion and combined outcomes before and after that time for a median follow-up of 11 years, Dr. Poole and colleagues reported.

In the ICD group, the overall hazard ratio for mortality by intention-to-treat was 0.87 (95% confidence interval, 0.76-0.98; P = .028), compared with the non-ICD control group.

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

A 10-year follow-up analysis based on one of cardiology’s most influential trials has shed further light on one of its key issues: how to sharpen selection of patients most likely to benefit from a primary prevention implantable cardioverter-defibrillator (ICD).

In a new report from SCD-HeFT, the survival advantage in patients with heart failure seen 5 years after receiving ICDs, compared with a non-ICD control group, narrowed a bit but remained significant after an additional 5 years. But not all patients with devices shared in that long-term ICD benefit. Patients with either ischemic disease or nonischemic cardiomyopathy (NICM) with devices showed a similar mortality risk reduction in the trial’s previously reported 5-year outcomes. That advantage, compared with non-ICD control patients, persisted throughout the subsequent 5 years for ischemic patients but tapered to nil for those with NICM.

The NICM patients “had what appears to be some accrual of benefit maybe out to about 6 years, and then the curves appear to come together where there’s no apparent further benefit after 6 years,” Jeanne E. Poole, MD, of the University of Washington, Seattle, said in an interview.

In both the 10-year analysis and the earlier results, ICD survival gains went preferentially to patients who enrolled with New York Heart Association (NYHA) functional class II symptoms. Patients who entered in NYHA class III “didn’t appear to have any benefit whatsoever” in either period, Dr. Poole said.

“The simple message is that the same groups of patients that benefited strongly from the ICD in the original SCD-HeFT – the NYHA class 2 patients and those with ischemic cardiomyopathy – were really the ones who benefited the greatest over the long term,” she said.

Dr. Poole is lead author on the SCD-HeFT 10-year analysis, which was published in the July 28 issue of the Journal of the American College of Cardiology.

Why the ICD survival effect disappeared midway in patients with NICM “is hard to sort out,” she said. Many in the control group were offered such devices after the trial concluded. Among those, it’s possible that disproportionately more control patients with NICM, compared with patients with ischemic disease, were fitted with ICDs that were also cardiac resynchronization therapy (CRT) devices, Dr. Poole and her colleagues speculated. That could have shifted their late outcomes to be more in line with patients who had received ICDs when the trial started.

Or “it is possible that the intermediate-term benefit of ICD therapy in NICM is overwhelmed by nonarrhythmic death in extended follow-up” given that ICDs prolong survival only by preventing arrhythmic death, noted an editorial accompanying the new SCD-HeFT publication.

Another possibility: Because NICM is a heterogeneous disorder with many potential causes, perhaps “the absence of long-term mortality benefit among SCD-HeFT participants with NICM was due to an unintended but preferential enrollment of subtypes at relatively lower risk for arrhythmic death in the longer term,” proposed Eric C. Stecker, MD, MPH, Oregon Health & Science University, Portland, and coauthors in their editorial.

“What are the take-away messages from the current analysis by Poole et al?” they asked. “These findings strongly support the clinical efficacy and cost-effectiveness of ICD therapy for the majority of patients with severe but mildly symptomatic ischemic cardiomyopathy who do not have an excessive comorbidity burden.”

But “the implications for patients with NICM are less clear,” they wrote. “Given evidence for intermediate-term benefit and the limitations inherent to assessing longer-term benefit, we do not believe it is appropriate to walk back guideline recommendations regarding ICD implantation for NICM patients.”

The findings in nonischemic patients invite comparison with the randomized DANISH trial, which entered only patients with NICM and, over more than 5 years, saw no primary-prevention ICD advantage for the end point of all-cause mortality.

But patients who received ICDs showed a reduction in arrhythmic death, a secondary end point. And mortality in the trial showed a significant interaction with patient age; survival went up sharply with ICDs for those younger than 60 years.

Also in DANISH, “the ICD treatment effect appears to vary over time, with an earlier phase showing possible survival benefit and a later phase showing attenuation of that benefit,” similar to what was seen long-term in SCD-HeFT, in which the interaction between mortality and time since implantation was significant at P = .0015, observe Dr. Poole and colleagues.

However, Dr. Poole cautioned when interviewed, patient management in DANISH, conducted exclusively in Denmark, may not have been representative of the rest of the world, complicating comparisons with other studies. For example, nearly 60% of all patients in DANISH had defibrillating CRT devices. Virtually everyone was on ACE inhibitors or angiotensin-receptor blockers, and almost 60% were taking aldosterone inhibitors.

“DANISH is an unusually high bar and probably does not reflect all patients with heart failure, and certainly does not reflect patients in the United States in terms of those high levels of guideline-directed medical therapy,” Dr. Poole said. The message from DANISH, she said, seems to be that patients with NICM who are definitely on goal-directed heart failure medications with CRT devices “probably don’t have a meaningful benefit from an ICD, on total mortality, because their sudden death rates are simply so low.”

SCD-HeFT had originally assigned 2,521 patients with heart failure of NYHA class II or III and an left ventricular ejection fraction of less than 35% to receive an ICD, amiodarone without an ICD, or an amiodarone placebo and no ICD; patients in the latter cohorts made up the non-ICD control group.

Those who received an ICD, compared with the non-ICD control patients, showed a 23% drop in all-cause mortality over a median of 45.5 months ending on October 31, 2003, Dr. Poole and colleagues noted in their current report. The trial’s primary results were unveiled 2005.

The current analysis, based on data collected in 2010 and 2011, followed the 1,855 patients alive at the trial’s official conclusion and combined outcomes before and after that time for a median follow-up of 11 years, Dr. Poole and colleagues reported.

In the ICD group, the overall hazard ratio for mortality by intention-to-treat was 0.87 (95% confidence interval, 0.76-0.98; P = .028), compared with the non-ICD control group.

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

The US Food and Drug Administration (FDA) has approved the triple-therapy combination of atezolizumab (Tecentriq) plus cobimetinib (Cotellic) and vemurafenib (Zelboraf) for the treatment of BRAF V600 mutation-positive advanced melanoma, according to a press statement from Genentech, which owns all three drugs.

This is the first melanoma indication for the PD-L1 inhibitor atezolizumab; the other two drugs, cobimetinib and vemurafenib, are a MEK- plus BRAF-inhibitor combination previously approved for BRAF-mutated melanoma.

The new approval is based on safety and efficacy results from the randomized, phase 3 IMspire150 study from patients with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma.

Progression-free survival (PFS), the primary endpoint, was improved by 4.5 months with the triple therapy compared to the doublet.

The addition of atezolizumab to cobimetinib and vemurafenib led to a longer median PFS of 15.1 months, compared to 10.6 months with placebo plus cobimetinib and vemurafenib (hazard ratio, 0.78; 95% CI, 0.63 – 0.97; P = .025).

The most common adverse reactions (rate ≥ 20%) in patients who received the triple combination were rash (75%), musculoskeletal pain (62%), fatigue (51%), hepatotoxicity (50%), pyrexia (49%), nausea (30%), pruritus (26%), edema (26%), stomatitis (23%), hypothyroidism (22%), and photosensitivity reaction (21%).

The review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that facilitates concurrent submission and review of oncology products among international partners.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the triple-therapy combination of atezolizumab (Tecentriq) plus cobimetinib (Cotellic) and vemurafenib (Zelboraf) for the treatment of BRAF V600 mutation-positive advanced melanoma, according to a press statement from Genentech, which owns all three drugs.

This is the first melanoma indication for the PD-L1 inhibitor atezolizumab; the other two drugs, cobimetinib and vemurafenib, are a MEK- plus BRAF-inhibitor combination previously approved for BRAF-mutated melanoma.

The new approval is based on safety and efficacy results from the randomized, phase 3 IMspire150 study from patients with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma.

Progression-free survival (PFS), the primary endpoint, was improved by 4.5 months with the triple therapy compared to the doublet.

The addition of atezolizumab to cobimetinib and vemurafenib led to a longer median PFS of 15.1 months, compared to 10.6 months with placebo plus cobimetinib and vemurafenib (hazard ratio, 0.78; 95% CI, 0.63 – 0.97; P = .025).

The most common adverse reactions (rate ≥ 20%) in patients who received the triple combination were rash (75%), musculoskeletal pain (62%), fatigue (51%), hepatotoxicity (50%), pyrexia (49%), nausea (30%), pruritus (26%), edema (26%), stomatitis (23%), hypothyroidism (22%), and photosensitivity reaction (21%).

The review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that facilitates concurrent submission and review of oncology products among international partners.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the triple-therapy combination of atezolizumab (Tecentriq) plus cobimetinib (Cotellic) and vemurafenib (Zelboraf) for the treatment of BRAF V600 mutation-positive advanced melanoma, according to a press statement from Genentech, which owns all three drugs.

This is the first melanoma indication for the PD-L1 inhibitor atezolizumab; the other two drugs, cobimetinib and vemurafenib, are a MEK- plus BRAF-inhibitor combination previously approved for BRAF-mutated melanoma.

The new approval is based on safety and efficacy results from the randomized, phase 3 IMspire150 study from patients with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma.

Progression-free survival (PFS), the primary endpoint, was improved by 4.5 months with the triple therapy compared to the doublet.

The addition of atezolizumab to cobimetinib and vemurafenib led to a longer median PFS of 15.1 months, compared to 10.6 months with placebo plus cobimetinib and vemurafenib (hazard ratio, 0.78; 95% CI, 0.63 – 0.97; P = .025).

The most common adverse reactions (rate ≥ 20%) in patients who received the triple combination were rash (75%), musculoskeletal pain (62%), fatigue (51%), hepatotoxicity (50%), pyrexia (49%), nausea (30%), pruritus (26%), edema (26%), stomatitis (23%), hypothyroidism (22%), and photosensitivity reaction (21%).

The review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that facilitates concurrent submission and review of oncology products among international partners.
 

This article first appeared on Medscape.com.

Improving hand hygiene, optimizing antibiotic order sets, and removing catheters sooner were among the interventions associated with a decreased risk of infections after hysterectomy, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

rclassenlayouts/Getty Images

“Implementation of bundled interventions and an institutional focus on reducing infection can successfully reduce the burden of posthysterectomy infectious morbidity,” said study author Shitanshu Uppal, MBBS, an ob.gyn. specializing in gynecologic oncology at the University of Michigan in Ann Arbor.

To assess the impact of quality improvement efforts on infectious morbidity after hysterectomy, Dr. Uppal and colleagues analyzed data from 1,867 hysterectomies performed between Oct. 8, 2015, and Oct. 7, 2018. Patients were at least 18 years old, younger than 90 years old, and underwent hysterectomy via any route at the University of Michigan Medical Center Hospital.

Interventions to reduce infections included the use of cefazolin as a preferred antibiotic, the addition of metronidazole to first-generation cephalosporins for antibiotic prophylaxis, subcuticular closure of open incisions, and earlier removal of Foley catheters. In addition, the institution evaluated and shared information about doctors’ hand hygiene, implemented enhanced recovery after surgery (ERAS) protocols, and held periodic meetings with doctors to discuss efforts to reduce infections. Most interventions were implemented by November 2017.

The primary outcome was overall infection rate in the 30 days after surgery for each of the 3 years included the study. Infections included superficial surgical site infections, deep infections, Clostridium difficile infections, and urinary tract infections, among others.

Patients’ baseline clinical characteristics did not differ during the 3 years studied. Length of stay decreased, which may be attributed to increased use of ERAS protocols and institution of same-day discharge in laparoscopic cases, Dr. Uppal said. The rate of malignancy on final pathology decreased from 29% in year 1 to 23% in year 3. The rate of laparoscopic surgery increased from 55% to 64%.

Infectious morbidity rates decreased from 7% in year 1 (47 infections per 644 cases) to 4% in year 3 (22 infections per 616 cases).

“We saw a reduction in infection rate in all categories,” said Dr. Uppal. “However, the reduction in urinary tract infection as well as superficial surgical site infection was most pronounced.”

After adjustment for the route of surgery, body mass index, age, malignancy on final pathology, modality of surgery, and comorbidities, performance of hysterectomy in year 3 was independently predictive of lower rates of infectious morbidity by 56%.

In addition, the standardized incidence ratio for surgical site infection as reported by the Centers for Medicare & Medicaid Services decreased. In December 2016, Michigan Medicine’s ratio was 1.057. At the end of 2018, the projected ratio was 0.243.

The interventions started on different dates, and “we are unable to conclude, from all the implemented interventions, which one worked,” Dr. Uppal noted.

“I hope the elements from this quality improvement initiative will become the standard of care in order to benefit our patients,” said Amy Park, MD, section head of female pelvic medicine and reconstructive surgery at Cleveland Clinic.

[email protected]

SOURCE: Uppal S et al. SGS 2020, Abstract 16.

Improving hand hygiene, optimizing antibiotic order sets, and removing catheters sooner were among the interventions associated with a decreased risk of infections after hysterectomy, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

rclassenlayouts/Getty Images

“Implementation of bundled interventions and an institutional focus on reducing infection can successfully reduce the burden of posthysterectomy infectious morbidity,” said study author Shitanshu Uppal, MBBS, an ob.gyn. specializing in gynecologic oncology at the University of Michigan in Ann Arbor.

To assess the impact of quality improvement efforts on infectious morbidity after hysterectomy, Dr. Uppal and colleagues analyzed data from 1,867 hysterectomies performed between Oct. 8, 2015, and Oct. 7, 2018. Patients were at least 18 years old, younger than 90 years old, and underwent hysterectomy via any route at the University of Michigan Medical Center Hospital.

Interventions to reduce infections included the use of cefazolin as a preferred antibiotic, the addition of metronidazole to first-generation cephalosporins for antibiotic prophylaxis, subcuticular closure of open incisions, and earlier removal of Foley catheters. In addition, the institution evaluated and shared information about doctors’ hand hygiene, implemented enhanced recovery after surgery (ERAS) protocols, and held periodic meetings with doctors to discuss efforts to reduce infections. Most interventions were implemented by November 2017.

The primary outcome was overall infection rate in the 30 days after surgery for each of the 3 years included the study. Infections included superficial surgical site infections, deep infections, Clostridium difficile infections, and urinary tract infections, among others.

Patients’ baseline clinical characteristics did not differ during the 3 years studied. Length of stay decreased, which may be attributed to increased use of ERAS protocols and institution of same-day discharge in laparoscopic cases, Dr. Uppal said. The rate of malignancy on final pathology decreased from 29% in year 1 to 23% in year 3. The rate of laparoscopic surgery increased from 55% to 64%.

Infectious morbidity rates decreased from 7% in year 1 (47 infections per 644 cases) to 4% in year 3 (22 infections per 616 cases).

“We saw a reduction in infection rate in all categories,” said Dr. Uppal. “However, the reduction in urinary tract infection as well as superficial surgical site infection was most pronounced.”

After adjustment for the route of surgery, body mass index, age, malignancy on final pathology, modality of surgery, and comorbidities, performance of hysterectomy in year 3 was independently predictive of lower rates of infectious morbidity by 56%.

In addition, the standardized incidence ratio for surgical site infection as reported by the Centers for Medicare & Medicaid Services decreased. In December 2016, Michigan Medicine’s ratio was 1.057. At the end of 2018, the projected ratio was 0.243.

The interventions started on different dates, and “we are unable to conclude, from all the implemented interventions, which one worked,” Dr. Uppal noted.

“I hope the elements from this quality improvement initiative will become the standard of care in order to benefit our patients,” said Amy Park, MD, section head of female pelvic medicine and reconstructive surgery at Cleveland Clinic.

[email protected]

SOURCE: Uppal S et al. SGS 2020, Abstract 16.

Improving hand hygiene, optimizing antibiotic order sets, and removing catheters sooner were among the interventions associated with a decreased risk of infections after hysterectomy, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

rclassenlayouts/Getty Images

“Implementation of bundled interventions and an institutional focus on reducing infection can successfully reduce the burden of posthysterectomy infectious morbidity,” said study author Shitanshu Uppal, MBBS, an ob.gyn. specializing in gynecologic oncology at the University of Michigan in Ann Arbor.

To assess the impact of quality improvement efforts on infectious morbidity after hysterectomy, Dr. Uppal and colleagues analyzed data from 1,867 hysterectomies performed between Oct. 8, 2015, and Oct. 7, 2018. Patients were at least 18 years old, younger than 90 years old, and underwent hysterectomy via any route at the University of Michigan Medical Center Hospital.

Interventions to reduce infections included the use of cefazolin as a preferred antibiotic, the addition of metronidazole to first-generation cephalosporins for antibiotic prophylaxis, subcuticular closure of open incisions, and earlier removal of Foley catheters. In addition, the institution evaluated and shared information about doctors’ hand hygiene, implemented enhanced recovery after surgery (ERAS) protocols, and held periodic meetings with doctors to discuss efforts to reduce infections. Most interventions were implemented by November 2017.

The primary outcome was overall infection rate in the 30 days after surgery for each of the 3 years included the study. Infections included superficial surgical site infections, deep infections, Clostridium difficile infections, and urinary tract infections, among others.

Patients’ baseline clinical characteristics did not differ during the 3 years studied. Length of stay decreased, which may be attributed to increased use of ERAS protocols and institution of same-day discharge in laparoscopic cases, Dr. Uppal said. The rate of malignancy on final pathology decreased from 29% in year 1 to 23% in year 3. The rate of laparoscopic surgery increased from 55% to 64%.

Infectious morbidity rates decreased from 7% in year 1 (47 infections per 644 cases) to 4% in year 3 (22 infections per 616 cases).

“We saw a reduction in infection rate in all categories,” said Dr. Uppal. “However, the reduction in urinary tract infection as well as superficial surgical site infection was most pronounced.”

After adjustment for the route of surgery, body mass index, age, malignancy on final pathology, modality of surgery, and comorbidities, performance of hysterectomy in year 3 was independently predictive of lower rates of infectious morbidity by 56%.

In addition, the standardized incidence ratio for surgical site infection as reported by the Centers for Medicare & Medicaid Services decreased. In December 2016, Michigan Medicine’s ratio was 1.057. At the end of 2018, the projected ratio was 0.243.

The interventions started on different dates, and “we are unable to conclude, from all the implemented interventions, which one worked,” Dr. Uppal noted.

“I hope the elements from this quality improvement initiative will become the standard of care in order to benefit our patients,” said Amy Park, MD, section head of female pelvic medicine and reconstructive surgery at Cleveland Clinic.

[email protected]

SOURCE: Uppal S et al. SGS 2020, Abstract 16.

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[polldaddy:10586792]

[polldaddy:10586792]

An erythematous rash was the most common cutaneous manifestation in patients with COVID-19, followed by chilblain-like lesions and urticaria-like lesions in a systematic review of mostly European studies.

Qing Zhao, MD, Xiaokai Fang, MD, and their colleagues at the Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venereology, in Jinan, China, reported the results of a literature review of 44 articles published through May 2020 that included 507 patients with cutaneous manifestations of COVID-19. The review was published in the Journal of The European Academy of Dermatology and Venereology.

Nearly all of the patients (96%) were from Europe, and more than half were women (60%), with an average age of 49 years. Most patients had multiple skin symptoms, with the most common being erythema (44%), chilblain-like lesions (20%), urticaria-like lesions (16%), vesicular manifestations (13%), livedo/necrosis (6%), and petechiae (almost 2%). The authors described erythema as being present in specific sites, such as the trunk, extremities, flexural regions, face, and mucous membranes. Slightly less than half of all patients had significant pruritus.

Data on systemic COVID-19 symptoms were available for 431 patients and included fever in about two-thirds of patients and cough in almost 70%, with dyspnea in almost half of patients. Almost 60% had fatigue, and almost 60% had asthenia. Information about the onset of skin symptoms was available in 88 patients; of these patients, lesions were seen an average of almost 10 days after systemic symptoms appeared and, in almost 15%, were the first symptoms noted.

Histopathologic exams were done for only 23 patients and, in all cases, showed “inflammatory features without specific pathological changes, such as lymphocyte infiltration.” In one study, reverse transcription polymerase chain reaction testing of skin biopsy specimens tested negative for SARS-CoV-2.

Expression of ACE2, the receptor of SARS-CoV-2, in the skin was evaluated in six of the studies. “Higher ACE2 expression was identified in keratinocytes, mainly in differentiating keratinocytes and basal cells compared to the other cells of skin tissues,” the authors wrote. These results were confirmed with immunohistochemistry, which, they said, found “ACE2-positive keratinocytes in the stratum basal, the stratum spinosum, and the stratum granulosum of epiderma.” They added that this provides evidence “for percutaneous infection or the entry of virus into patients through skin tissues,” but cautioned that more research is needed.

The authors acknowledged that there are still many unanswered questions about COVID-19, and that more clinical data and research are needed, to improve the understanding of the cutaneous manifestations associated with COVID-19.

Pathogenesis of different cutaneous manifestations may be different, Dr. Femia said. For example, urticaria and morbilliform eruption were described by the authors of the review as more benign eruptions, but pathogenesis may differ from that of so-called COVID toes and from the pathogenesis of purpura and ulcerations seen in patients with more severe disease, she noted. It is plausible, she added, that purpura and ulcerations may be a “direct invasion of SARS-CoV-2 into endothelial cells,” which creates secondary processes “that ultimately destroy the skin.”

Urticaria and morbilliform eruptions, on the other hand, “are more simply that the immune system is recognizing COVID, and in doing so, is also recognizing some antigens in the skin and creating a hypersensitive response to the skin” and has “nothing to do with the SARS-CoV-2 virus actually being in that location,” she said.

It is important to differentiate between patients who have skin manifestations attributed to COVID-19 and those with manifestations independent of COVID-19, which is difficult, Dr. Femia noted. A patient with COVID-19 and a cutaneous manifestation may be having a reaction to a medication. “It’s important to have a critical eye and to remember that, when we see these manifestations, we should always be investigating whether there was an alternative cause so that we can better learn what exactly we should be attributing to this infection,” she said

Adam Friedman, MD, professor and interim chair of dermatology at George Washington University, Washington, said the authors of the review had presented interesting work, but made some “assumptions that need to be proven.” Dr. Friedman also was not involved in the research, but agreed in an interview with the assessment that it is unlikely SARS-CoV-2 would penetrate the skin. While some viruses – such as the poxvirus that causes molluscum contagiosum and the herpes simplex virus – invade keratinocytes specifically, there is a particular clinical phenotype that results that is associated with changes in the epidermis. However, “the skin manifestations of COVID-19 do not fit with direct skin invasion, [but] rather the immune response to systemic disease,” he said.

“[I]n terms of systemic invasion through the skin, it is possible, but this study certainly doesn’t show that. The presence/expression of ACE2 in the epidermis doesn’t translate to route of infection,” Dr. Friedman said..

The study received financial support from Shandong First Medical University, the Innovation Project of Shandong Academy of Medical Sciences and the Shandong Province Taishan Scholar Project. The authors report no relevant financial disclosures. Dr. Femia and Dr. Friedman had no relevant financial disclosures.

SOURCE: Zhao Q et al. J Eur Acad Dermatol Venereol. 2020 Jun 28. doi: 10.1111/jdv.16778.

An erythematous rash was the most common cutaneous manifestation in patients with COVID-19, followed by chilblain-like lesions and urticaria-like lesions in a systematic review of mostly European studies.

Qing Zhao, MD, Xiaokai Fang, MD, and their colleagues at the Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venereology, in Jinan, China, reported the results of a literature review of 44 articles published through May 2020 that included 507 patients with cutaneous manifestations of COVID-19. The review was published in the Journal of The European Academy of Dermatology and Venereology.

Nearly all of the patients (96%) were from Europe, and more than half were women (60%), with an average age of 49 years. Most patients had multiple skin symptoms, with the most common being erythema (44%), chilblain-like lesions (20%), urticaria-like lesions (16%), vesicular manifestations (13%), livedo/necrosis (6%), and petechiae (almost 2%). The authors described erythema as being present in specific sites, such as the trunk, extremities, flexural regions, face, and mucous membranes. Slightly less than half of all patients had significant pruritus.

Data on systemic COVID-19 symptoms were available for 431 patients and included fever in about two-thirds of patients and cough in almost 70%, with dyspnea in almost half of patients. Almost 60% had fatigue, and almost 60% had asthenia. Information about the onset of skin symptoms was available in 88 patients; of these patients, lesions were seen an average of almost 10 days after systemic symptoms appeared and, in almost 15%, were the first symptoms noted.

Histopathologic exams were done for only 23 patients and, in all cases, showed “inflammatory features without specific pathological changes, such as lymphocyte infiltration.” In one study, reverse transcription polymerase chain reaction testing of skin biopsy specimens tested negative for SARS-CoV-2.

Expression of ACE2, the receptor of SARS-CoV-2, in the skin was evaluated in six of the studies. “Higher ACE2 expression was identified in keratinocytes, mainly in differentiating keratinocytes and basal cells compared to the other cells of skin tissues,” the authors wrote. These results were confirmed with immunohistochemistry, which, they said, found “ACE2-positive keratinocytes in the stratum basal, the stratum spinosum, and the stratum granulosum of epiderma.” They added that this provides evidence “for percutaneous infection or the entry of virus into patients through skin tissues,” but cautioned that more research is needed.

The authors acknowledged that there are still many unanswered questions about COVID-19, and that more clinical data and research are needed, to improve the understanding of the cutaneous manifestations associated with COVID-19.

Pathogenesis of different cutaneous manifestations may be different, Dr. Femia said. For example, urticaria and morbilliform eruption were described by the authors of the review as more benign eruptions, but pathogenesis may differ from that of so-called COVID toes and from the pathogenesis of purpura and ulcerations seen in patients with more severe disease, she noted. It is plausible, she added, that purpura and ulcerations may be a “direct invasion of SARS-CoV-2 into endothelial cells,” which creates secondary processes “that ultimately destroy the skin.”

Urticaria and morbilliform eruptions, on the other hand, “are more simply that the immune system is recognizing COVID, and in doing so, is also recognizing some antigens in the skin and creating a hypersensitive response to the skin” and has “nothing to do with the SARS-CoV-2 virus actually being in that location,” she said.

It is important to differentiate between patients who have skin manifestations attributed to COVID-19 and those with manifestations independent of COVID-19, which is difficult, Dr. Femia noted. A patient with COVID-19 and a cutaneous manifestation may be having a reaction to a medication. “It’s important to have a critical eye and to remember that, when we see these manifestations, we should always be investigating whether there was an alternative cause so that we can better learn what exactly we should be attributing to this infection,” she said

Adam Friedman, MD, professor and interim chair of dermatology at George Washington University, Washington, said the authors of the review had presented interesting work, but made some “assumptions that need to be proven.” Dr. Friedman also was not involved in the research, but agreed in an interview with the assessment that it is unlikely SARS-CoV-2 would penetrate the skin. While some viruses – such as the poxvirus that causes molluscum contagiosum and the herpes simplex virus – invade keratinocytes specifically, there is a particular clinical phenotype that results that is associated with changes in the epidermis. However, “the skin manifestations of COVID-19 do not fit with direct skin invasion, [but] rather the immune response to systemic disease,” he said.

“[I]n terms of systemic invasion through the skin, it is possible, but this study certainly doesn’t show that. The presence/expression of ACE2 in the epidermis doesn’t translate to route of infection,” Dr. Friedman said..

The study received financial support from Shandong First Medical University, the Innovation Project of Shandong Academy of Medical Sciences and the Shandong Province Taishan Scholar Project. The authors report no relevant financial disclosures. Dr. Femia and Dr. Friedman had no relevant financial disclosures.

SOURCE: Zhao Q et al. J Eur Acad Dermatol Venereol. 2020 Jun 28. doi: 10.1111/jdv.16778.

An erythematous rash was the most common cutaneous manifestation in patients with COVID-19, followed by chilblain-like lesions and urticaria-like lesions in a systematic review of mostly European studies.

Qing Zhao, MD, Xiaokai Fang, MD, and their colleagues at the Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venereology, in Jinan, China, reported the results of a literature review of 44 articles published through May 2020 that included 507 patients with cutaneous manifestations of COVID-19. The review was published in the Journal of The European Academy of Dermatology and Venereology.

Nearly all of the patients (96%) were from Europe, and more than half were women (60%), with an average age of 49 years. Most patients had multiple skin symptoms, with the most common being erythema (44%), chilblain-like lesions (20%), urticaria-like lesions (16%), vesicular manifestations (13%), livedo/necrosis (6%), and petechiae (almost 2%). The authors described erythema as being present in specific sites, such as the trunk, extremities, flexural regions, face, and mucous membranes. Slightly less than half of all patients had significant pruritus.

Data on systemic COVID-19 symptoms were available for 431 patients and included fever in about two-thirds of patients and cough in almost 70%, with dyspnea in almost half of patients. Almost 60% had fatigue, and almost 60% had asthenia. Information about the onset of skin symptoms was available in 88 patients; of these patients, lesions were seen an average of almost 10 days after systemic symptoms appeared and, in almost 15%, were the first symptoms noted.

Histopathologic exams were done for only 23 patients and, in all cases, showed “inflammatory features without specific pathological changes, such as lymphocyte infiltration.” In one study, reverse transcription polymerase chain reaction testing of skin biopsy specimens tested negative for SARS-CoV-2.

Expression of ACE2, the receptor of SARS-CoV-2, in the skin was evaluated in six of the studies. “Higher ACE2 expression was identified in keratinocytes, mainly in differentiating keratinocytes and basal cells compared to the other cells of skin tissues,” the authors wrote. These results were confirmed with immunohistochemistry, which, they said, found “ACE2-positive keratinocytes in the stratum basal, the stratum spinosum, and the stratum granulosum of epiderma.” They added that this provides evidence “for percutaneous infection or the entry of virus into patients through skin tissues,” but cautioned that more research is needed.

The authors acknowledged that there are still many unanswered questions about COVID-19, and that more clinical data and research are needed, to improve the understanding of the cutaneous manifestations associated with COVID-19.

Pathogenesis of different cutaneous manifestations may be different, Dr. Femia said. For example, urticaria and morbilliform eruption were described by the authors of the review as more benign eruptions, but pathogenesis may differ from that of so-called COVID toes and from the pathogenesis of purpura and ulcerations seen in patients with more severe disease, she noted. It is plausible, she added, that purpura and ulcerations may be a “direct invasion of SARS-CoV-2 into endothelial cells,” which creates secondary processes “that ultimately destroy the skin.”

Urticaria and morbilliform eruptions, on the other hand, “are more simply that the immune system is recognizing COVID, and in doing so, is also recognizing some antigens in the skin and creating a hypersensitive response to the skin” and has “nothing to do with the SARS-CoV-2 virus actually being in that location,” she said.

It is important to differentiate between patients who have skin manifestations attributed to COVID-19 and those with manifestations independent of COVID-19, which is difficult, Dr. Femia noted. A patient with COVID-19 and a cutaneous manifestation may be having a reaction to a medication. “It’s important to have a critical eye and to remember that, when we see these manifestations, we should always be investigating whether there was an alternative cause so that we can better learn what exactly we should be attributing to this infection,” she said

Adam Friedman, MD, professor and interim chair of dermatology at George Washington University, Washington, said the authors of the review had presented interesting work, but made some “assumptions that need to be proven.” Dr. Friedman also was not involved in the research, but agreed in an interview with the assessment that it is unlikely SARS-CoV-2 would penetrate the skin. While some viruses – such as the poxvirus that causes molluscum contagiosum and the herpes simplex virus – invade keratinocytes specifically, there is a particular clinical phenotype that results that is associated with changes in the epidermis. However, “the skin manifestations of COVID-19 do not fit with direct skin invasion, [but] rather the immune response to systemic disease,” he said.

“[I]n terms of systemic invasion through the skin, it is possible, but this study certainly doesn’t show that. The presence/expression of ACE2 in the epidermis doesn’t translate to route of infection,” Dr. Friedman said..

The study received financial support from Shandong First Medical University, the Innovation Project of Shandong Academy of Medical Sciences and the Shandong Province Taishan Scholar Project. The authors report no relevant financial disclosures. Dr. Femia and Dr. Friedman had no relevant financial disclosures.

SOURCE: Zhao Q et al. J Eur Acad Dermatol Venereol. 2020 Jun 28. doi: 10.1111/jdv.16778.

When the pandemic was just emerging from its infancy and we were just beginning to think about social distancing, I was sitting around enjoying an adult beverage and some gluten free (not my choice) snacks with some friends. A retired nurse who had just celebrated her 80th birthday said, “I can’t wait until they’ve developed a vaccine.” A former electrical engineer sitting just short of 2 meters to her left responded, “Don’t save me a place near the front of the line for something that is being developed in a program called Warp Speed.”

Micah Young/istockphoto.com

How do you feel about the potential SARS-CoV-2 vaccine? Are you going to roll up your sleeve as soon as the vaccine becomes available in your community? What are you going to suggest to your patients, your children? I suspect many of you will answer, “It depends.” What factors will you be considering when you try to decide between what is likely to be several competing SARS-CoV-2 vaccines?

Will it make any difference to you which biochemical-immune-bending strategy is being used to make the vaccine? All of them will probably be the result of a clever sounding but novel technique, all of them with a track record that is measured in months and not years. Will you be swayed by how large the trials were? Or how long the follow-up lasted? How effective must the vaccine be to convince you that it is worth receiving or recommending? Do you have the tools and experience to make a decision like that? I know I don’t. And should you and I even be put in a position to make that decision?

In the past, you and I may have relied on the Centers for Disease Control and Prevention for advice. But given the somewhat murky and stormy relationship between the CDC and the president, the vaccine recommendation may be issued by the White House and not the CDC.

For those of us who were practicing medicine during the Swine Flu fiasco of 1976, the pace and the politics surrounding the development of a SARS-CoV-2 vaccine has a discomforting déjà vu quality about it. The fact that like this year 1976 was an election year that infused the development process with a sense of urgency above and beyond any of the concerns about the pandemic that never happened. Although causality was never proven, there was a surge in Guillain-Barré syndrome cases that had been linked temporally to the vaccine.

Of course, our pandemic is real, and it would be imprudent to wait a year or more to watch for long-term vaccine sequelae. However, I am more than a little concerned that fast tracking the development process may result in unfortunate consequences in the short term that could have been avoided with a more measured approach to trialing the vaccines.

The sad reality is that as a nation we tend to be impatient. We are drawn to quick fixes that come in a vial or a capsule. We are learning that simple measures like mask wearing and social distancing can make a difference in slowing the spread of the virus. It would be tragic to rush a vaccine into production that at best turns out to simply be an expensive alternative to the measures that we know work or at worst injures more of us than it saves.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

When the pandemic was just emerging from its infancy and we were just beginning to think about social distancing, I was sitting around enjoying an adult beverage and some gluten free (not my choice) snacks with some friends. A retired nurse who had just celebrated her 80th birthday said, “I can’t wait until they’ve developed a vaccine.” A former electrical engineer sitting just short of 2 meters to her left responded, “Don’t save me a place near the front of the line for something that is being developed in a program called Warp Speed.”

Micah Young/istockphoto.com

How do you feel about the potential SARS-CoV-2 vaccine? Are you going to roll up your sleeve as soon as the vaccine becomes available in your community? What are you going to suggest to your patients, your children? I suspect many of you will answer, “It depends.” What factors will you be considering when you try to decide between what is likely to be several competing SARS-CoV-2 vaccines?

Will it make any difference to you which biochemical-immune-bending strategy is being used to make the vaccine? All of them will probably be the result of a clever sounding but novel technique, all of them with a track record that is measured in months and not years. Will you be swayed by how large the trials were? Or how long the follow-up lasted? How effective must the vaccine be to convince you that it is worth receiving or recommending? Do you have the tools and experience to make a decision like that? I know I don’t. And should you and I even be put in a position to make that decision?

In the past, you and I may have relied on the Centers for Disease Control and Prevention for advice. But given the somewhat murky and stormy relationship between the CDC and the president, the vaccine recommendation may be issued by the White House and not the CDC.

For those of us who were practicing medicine during the Swine Flu fiasco of 1976, the pace and the politics surrounding the development of a SARS-CoV-2 vaccine has a discomforting déjà vu quality about it. The fact that like this year 1976 was an election year that infused the development process with a sense of urgency above and beyond any of the concerns about the pandemic that never happened. Although causality was never proven, there was a surge in Guillain-Barré syndrome cases that had been linked temporally to the vaccine.

Of course, our pandemic is real, and it would be imprudent to wait a year or more to watch for long-term vaccine sequelae. However, I am more than a little concerned that fast tracking the development process may result in unfortunate consequences in the short term that could have been avoided with a more measured approach to trialing the vaccines.

The sad reality is that as a nation we tend to be impatient. We are drawn to quick fixes that come in a vial or a capsule. We are learning that simple measures like mask wearing and social distancing can make a difference in slowing the spread of the virus. It would be tragic to rush a vaccine into production that at best turns out to simply be an expensive alternative to the measures that we know work or at worst injures more of us than it saves.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

When the pandemic was just emerging from its infancy and we were just beginning to think about social distancing, I was sitting around enjoying an adult beverage and some gluten free (not my choice) snacks with some friends. A retired nurse who had just celebrated her 80th birthday said, “I can’t wait until they’ve developed a vaccine.” A former electrical engineer sitting just short of 2 meters to her left responded, “Don’t save me a place near the front of the line for something that is being developed in a program called Warp Speed.”

Micah Young/istockphoto.com

How do you feel about the potential SARS-CoV-2 vaccine? Are you going to roll up your sleeve as soon as the vaccine becomes available in your community? What are you going to suggest to your patients, your children? I suspect many of you will answer, “It depends.” What factors will you be considering when you try to decide between what is likely to be several competing SARS-CoV-2 vaccines?

Will it make any difference to you which biochemical-immune-bending strategy is being used to make the vaccine? All of them will probably be the result of a clever sounding but novel technique, all of them with a track record that is measured in months and not years. Will you be swayed by how large the trials were? Or how long the follow-up lasted? How effective must the vaccine be to convince you that it is worth receiving or recommending? Do you have the tools and experience to make a decision like that? I know I don’t. And should you and I even be put in a position to make that decision?

In the past, you and I may have relied on the Centers for Disease Control and Prevention for advice. But given the somewhat murky and stormy relationship between the CDC and the president, the vaccine recommendation may be issued by the White House and not the CDC.

For those of us who were practicing medicine during the Swine Flu fiasco of 1976, the pace and the politics surrounding the development of a SARS-CoV-2 vaccine has a discomforting déjà vu quality about it. The fact that like this year 1976 was an election year that infused the development process with a sense of urgency above and beyond any of the concerns about the pandemic that never happened. Although causality was never proven, there was a surge in Guillain-Barré syndrome cases that had been linked temporally to the vaccine.

Of course, our pandemic is real, and it would be imprudent to wait a year or more to watch for long-term vaccine sequelae. However, I am more than a little concerned that fast tracking the development process may result in unfortunate consequences in the short term that could have been avoided with a more measured approach to trialing the vaccines.

The sad reality is that as a nation we tend to be impatient. We are drawn to quick fixes that come in a vial or a capsule. We are learning that simple measures like mask wearing and social distancing can make a difference in slowing the spread of the virus. It would be tragic to rush a vaccine into production that at best turns out to simply be an expensive alternative to the measures that we know work or at worst injures more of us than it saves.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

It turns out that a pandemic, at least this COVID-19 version, can be a challenge for folks like me who are seldom at a loss for words. The pandemic has so overwhelmed every corner of our lives that it is hard to think of another topic on which to pontificate and still not tromp on someone’s political toes. One can always write about the pandemic itself, and I’ve tried that, but as the curtain is gradually being pulled back on this crafty little germ one runs the risk of making an observation today that will be disproved in a week or 2. However, I can’t suppress my urge to write, and so I have decided to share a few brief random observations. Of course they are related to the pandemic. And of course I realize that there is a better than fifty percent chance that they will be proved wrong by the time you read my next Letters from Maine.

Under the radar

Phynart Studio/Getty Images

Two of the many mysteries about SARS-CoV-2 involve young children who as a group appear to be less easily infected than adults and even when infected seem to be less likely to spread the disease to other people, particularly adults. One explanation posited by some researchers in France is that young children are less likely to have symptoms such as cough and are less powerful speakers and so might be less likely to spew out a significant number of infected aerosolized droplets (“How to Reopen Schools: What Science and Other Countries Teach Us.” By Pam Belluck, Apoorva Mandavill, and Benedict Carey. New York Times, July 11, 2020). While there are probably several factors to explain this observation, one may be that young children are short, seldom taller than an adult waistline. I suspect the majority of aerosols they emit fall and inactivate harmlessly to the floor several feet below an adult’s nose and mouth. Regardless of the explanation, it appears to be good news for the opening of schools, at least for the early grades.

Forget the deep cleaning

There has been a glut of news stories about reopening schools, and many of these stories are accompanied by images of school custodians with buckets, mops, spray bottles, and sponges scouring desks and walls. The most recent image in our local newspaper was of someone scrubbing the underside of a desk. I know it’s taking the World Health Organization an unconscionable period of time to acknowledge that SARS-CoV-2 is airborne, but the rest of us should have gotten the message long ago and been directing our attention to air handling and ventilation. The urge to scrub and deep clean is a hard habit to break, but this nasty bug is not like influenza or a flesh eating bacteria in which deep cleaning might help. A better image to attach to a story on school reopening would be one of a custodian with a screwdriver struggling to pry open a classroom window that had been painted shut a decade ago.

Managing the inevitable

Middlebury College in Vermont and Bowdoin College here in Brunswick, Maine, are similar in many respects because they are small and situated in relatively isolated small New England towns with good track records for pandemic management. Middlebury has elected to invite all its 2,750 students back to campus, whereas Bowdoin has decided to allow only incoming first years and transfer students (for a total of about 600) to return. Both schools will institute similar testing and social distancing protocols and restrict students from access to their respective towns (“A Tale of 2 Colleges.” By Bill Burger. Inside Higher Ed, June 29,2020). It will be an interesting experiment. I’m voting for Middlebury and not because my son and daughter-in-law are alums, but because I think Middlebury seems to have acknowledged that no matter how diligent one is in creating a SARS-CoV-2–free environment at the outset, these are college kids and there will be some cases on both campuses. It is on how those inevitable realities are managed and contained that an institution should be judged.

Patience

Unfortunately, the pandemic has exposed some of our weaknesses as a nation. We always have been a restless and impatient population eager to get moving and it has driven us to greatness. Hopefully, patience will be a lesson that we will learn, along with many others.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

It turns out that a pandemic, at least this COVID-19 version, can be a challenge for folks like me who are seldom at a loss for words. The pandemic has so overwhelmed every corner of our lives that it is hard to think of another topic on which to pontificate and still not tromp on someone’s political toes. One can always write about the pandemic itself, and I’ve tried that, but as the curtain is gradually being pulled back on this crafty little germ one runs the risk of making an observation today that will be disproved in a week or 2. However, I can’t suppress my urge to write, and so I have decided to share a few brief random observations. Of course they are related to the pandemic. And of course I realize that there is a better than fifty percent chance that they will be proved wrong by the time you read my next Letters from Maine.

Under the radar

Phynart Studio/Getty Images

Two of the many mysteries about SARS-CoV-2 involve young children who as a group appear to be less easily infected than adults and even when infected seem to be less likely to spread the disease to other people, particularly adults. One explanation posited by some researchers in France is that young children are less likely to have symptoms such as cough and are less powerful speakers and so might be less likely to spew out a significant number of infected aerosolized droplets (“How to Reopen Schools: What Science and Other Countries Teach Us.” By Pam Belluck, Apoorva Mandavill, and Benedict Carey. New York Times, July 11, 2020). While there are probably several factors to explain this observation, one may be that young children are short, seldom taller than an adult waistline. I suspect the majority of aerosols they emit fall and inactivate harmlessly to the floor several feet below an adult’s nose and mouth. Regardless of the explanation, it appears to be good news for the opening of schools, at least for the early grades.

Forget the deep cleaning

There has been a glut of news stories about reopening schools, and many of these stories are accompanied by images of school custodians with buckets, mops, spray bottles, and sponges scouring desks and walls. The most recent image in our local newspaper was of someone scrubbing the underside of a desk. I know it’s taking the World Health Organization an unconscionable period of time to acknowledge that SARS-CoV-2 is airborne, but the rest of us should have gotten the message long ago and been directing our attention to air handling and ventilation. The urge to scrub and deep clean is a hard habit to break, but this nasty bug is not like influenza or a flesh eating bacteria in which deep cleaning might help. A better image to attach to a story on school reopening would be one of a custodian with a screwdriver struggling to pry open a classroom window that had been painted shut a decade ago.

Managing the inevitable

Middlebury College in Vermont and Bowdoin College here in Brunswick, Maine, are similar in many respects because they are small and situated in relatively isolated small New England towns with good track records for pandemic management. Middlebury has elected to invite all its 2,750 students back to campus, whereas Bowdoin has decided to allow only incoming first years and transfer students (for a total of about 600) to return. Both schools will institute similar testing and social distancing protocols and restrict students from access to their respective towns (“A Tale of 2 Colleges.” By Bill Burger. Inside Higher Ed, June 29,2020). It will be an interesting experiment. I’m voting for Middlebury and not because my son and daughter-in-law are alums, but because I think Middlebury seems to have acknowledged that no matter how diligent one is in creating a SARS-CoV-2–free environment at the outset, these are college kids and there will be some cases on both campuses. It is on how those inevitable realities are managed and contained that an institution should be judged.

Patience

Unfortunately, the pandemic has exposed some of our weaknesses as a nation. We always have been a restless and impatient population eager to get moving and it has driven us to greatness. Hopefully, patience will be a lesson that we will learn, along with many others.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

It turns out that a pandemic, at least this COVID-19 version, can be a challenge for folks like me who are seldom at a loss for words. The pandemic has so overwhelmed every corner of our lives that it is hard to think of another topic on which to pontificate and still not tromp on someone’s political toes. One can always write about the pandemic itself, and I’ve tried that, but as the curtain is gradually being pulled back on this crafty little germ one runs the risk of making an observation today that will be disproved in a week or 2. However, I can’t suppress my urge to write, and so I have decided to share a few brief random observations. Of course they are related to the pandemic. And of course I realize that there is a better than fifty percent chance that they will be proved wrong by the time you read my next Letters from Maine.

Under the radar

Phynart Studio/Getty Images

Two of the many mysteries about SARS-CoV-2 involve young children who as a group appear to be less easily infected than adults and even when infected seem to be less likely to spread the disease to other people, particularly adults. One explanation posited by some researchers in France is that young children are less likely to have symptoms such as cough and are less powerful speakers and so might be less likely to spew out a significant number of infected aerosolized droplets (“How to Reopen Schools: What Science and Other Countries Teach Us.” By Pam Belluck, Apoorva Mandavill, and Benedict Carey. New York Times, July 11, 2020). While there are probably several factors to explain this observation, one may be that young children are short, seldom taller than an adult waistline. I suspect the majority of aerosols they emit fall and inactivate harmlessly to the floor several feet below an adult’s nose and mouth. Regardless of the explanation, it appears to be good news for the opening of schools, at least for the early grades.

Forget the deep cleaning

There has been a glut of news stories about reopening schools, and many of these stories are accompanied by images of school custodians with buckets, mops, spray bottles, and sponges scouring desks and walls. The most recent image in our local newspaper was of someone scrubbing the underside of a desk. I know it’s taking the World Health Organization an unconscionable period of time to acknowledge that SARS-CoV-2 is airborne, but the rest of us should have gotten the message long ago and been directing our attention to air handling and ventilation. The urge to scrub and deep clean is a hard habit to break, but this nasty bug is not like influenza or a flesh eating bacteria in which deep cleaning might help. A better image to attach to a story on school reopening would be one of a custodian with a screwdriver struggling to pry open a classroom window that had been painted shut a decade ago.

Managing the inevitable

Middlebury College in Vermont and Bowdoin College here in Brunswick, Maine, are similar in many respects because they are small and situated in relatively isolated small New England towns with good track records for pandemic management. Middlebury has elected to invite all its 2,750 students back to campus, whereas Bowdoin has decided to allow only incoming first years and transfer students (for a total of about 600) to return. Both schools will institute similar testing and social distancing protocols and restrict students from access to their respective towns (“A Tale of 2 Colleges.” By Bill Burger. Inside Higher Ed, June 29,2020). It will be an interesting experiment. I’m voting for Middlebury and not because my son and daughter-in-law are alums, but because I think Middlebury seems to have acknowledged that no matter how diligent one is in creating a SARS-CoV-2–free environment at the outset, these are college kids and there will be some cases on both campuses. It is on how those inevitable realities are managed and contained that an institution should be judged.

Patience

Unfortunately, the pandemic has exposed some of our weaknesses as a nation. We always have been a restless and impatient population eager to get moving and it has driven us to greatness. Hopefully, patience will be a lesson that we will learn, along with many others.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Biomedical science is ever changing, and what may be believed in one era – for instance, bloodletting can cure disease or lobotomies can treat psychiatric disorders – may not be accepted in the next. However, one medical advance stands out in terms of maintaining and sustaining our health: vaccines. The data comparing morbidity and mortality before and after widespread vaccination are staggering. Before the smallpox vaccine, nearly 49,000 people were infected and more than 1,500 died annually from smallpox; by 1977, the vaccine eradicated the disease in the United States.¹ Polio caused paralytic disease in more than 16,000 people per year in the United States, including, perhaps most famously, President Franklin Roosevelt. After development of the polio vaccine, cases and deaths dropped to zero.²

Despite the evidence indicating the effectiveness of vaccines to reduce disease and death, rates of vaccination in the United States remain low among adults, ranging from about 23% for pneumococcal disease to 45% for seasonal influenza.³ Childhood immunization in 2017 hovered around 70% for those receiving all the recommended vaccines.⁴ Clearly there is room for improvement.

A woman’s ob.gyn. may be the only medical professional she sees regularly, and her annual well visit may be the only time she receives information regarding her weight and blood pressure, or reviews her current medications. For women who are planning pregnancy, pregnant, or post partum, ob.gyn. consultations present unique opportunities to increase patient engagement in healthy behaviors, such as diet, exercise, and regular sleep, because women are highly motivated to do what is best for their babies.

Immunization during pregnancy not only reduces the mother’s risk of severe disease, which can lead to complications, defects, and fetal or perinatal death, but also has been shown to improve the neonate’s ability to fight infection and may reduce vertical transmission of certain diseases. In this era of COVID-19 where we have no vaccine but we have evidence that pregnant women may be at greater risk for severe disease,⁵ routine immunizations are vital to maternal and fetal health.

We have invited Laura E. Riley, MD, chair of obstetrics and gynecology at Weill Cornell Medicine, New York, to address the importance of vaccination and the role of the ob.gyn. in advocating for this life-saving preventive health measure. Dr. Riley disclosed she is an author for Up to Date and was a consultant to GlaxoSmithKline about a cytomegalovirus vaccine. 

Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, Baltimore County, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at [email protected].

References

1. MMWR Morb Mortal Wkly Rep. 1999 Apr 2;48(12);243-8.

2. JAMA. 2007 Nov 14;298(18):2155-63.

3. MMWR Morb Mortal Wkly Rep. 2017 May 5;66(11);1-28.

4. CDC National Center for Health Statistics FastStats on Immunization.

5. MMWR Morb Mortal Wkly Rep. 2020 Jun 26;69(25);769-75.

Biomedical science is ever changing, and what may be believed in one era – for instance, bloodletting can cure disease or lobotomies can treat psychiatric disorders – may not be accepted in the next. However, one medical advance stands out in terms of maintaining and sustaining our health: vaccines. The data comparing morbidity and mortality before and after widespread vaccination are staggering. Before the smallpox vaccine, nearly 49,000 people were infected and more than 1,500 died annually from smallpox; by 1977, the vaccine eradicated the disease in the United States.¹ Polio caused paralytic disease in more than 16,000 people per year in the United States, including, perhaps most famously, President Franklin Roosevelt. After development of the polio vaccine, cases and deaths dropped to zero.²

Despite the evidence indicating the effectiveness of vaccines to reduce disease and death, rates of vaccination in the United States remain low among adults, ranging from about 23% for pneumococcal disease to 45% for seasonal influenza.³ Childhood immunization in 2017 hovered around 70% for those receiving all the recommended vaccines.⁴ Clearly there is room for improvement.

A woman’s ob.gyn. may be the only medical professional she sees regularly, and her annual well visit may be the only time she receives information regarding her weight and blood pressure, or reviews her current medications. For women who are planning pregnancy, pregnant, or post partum, ob.gyn. consultations present unique opportunities to increase patient engagement in healthy behaviors, such as diet, exercise, and regular sleep, because women are highly motivated to do what is best for their babies.

Immunization during pregnancy not only reduces the mother’s risk of severe disease, which can lead to complications, defects, and fetal or perinatal death, but also has been shown to improve the neonate’s ability to fight infection and may reduce vertical transmission of certain diseases. In this era of COVID-19 where we have no vaccine but we have evidence that pregnant women may be at greater risk for severe disease,⁵ routine immunizations are vital to maternal and fetal health.

We have invited Laura E. Riley, MD, chair of obstetrics and gynecology at Weill Cornell Medicine, New York, to address the importance of vaccination and the role of the ob.gyn. in advocating for this life-saving preventive health measure. Dr. Riley disclosed she is an author for Up to Date and was a consultant to GlaxoSmithKline about a cytomegalovirus vaccine. 

Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, Baltimore County, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at [email protected].

References

1. MMWR Morb Mortal Wkly Rep. 1999 Apr 2;48(12);243-8.

2. JAMA. 2007 Nov 14;298(18):2155-63.

3. MMWR Morb Mortal Wkly Rep. 2017 May 5;66(11);1-28.

4. CDC National Center for Health Statistics FastStats on Immunization.

5. MMWR Morb Mortal Wkly Rep. 2020 Jun 26;69(25);769-75.

Biomedical science is ever changing, and what may be believed in one era – for instance, bloodletting can cure disease or lobotomies can treat psychiatric disorders – may not be accepted in the next. However, one medical advance stands out in terms of maintaining and sustaining our health: vaccines. The data comparing morbidity and mortality before and after widespread vaccination are staggering. Before the smallpox vaccine, nearly 49,000 people were infected and more than 1,500 died annually from smallpox; by 1977, the vaccine eradicated the disease in the United States.¹ Polio caused paralytic disease in more than 16,000 people per year in the United States, including, perhaps most famously, President Franklin Roosevelt. After development of the polio vaccine, cases and deaths dropped to zero.²

Despite the evidence indicating the effectiveness of vaccines to reduce disease and death, rates of vaccination in the United States remain low among adults, ranging from about 23% for pneumococcal disease to 45% for seasonal influenza.³ Childhood immunization in 2017 hovered around 70% for those receiving all the recommended vaccines.⁴ Clearly there is room for improvement.

A woman’s ob.gyn. may be the only medical professional she sees regularly, and her annual well visit may be the only time she receives information regarding her weight and blood pressure, or reviews her current medications. For women who are planning pregnancy, pregnant, or post partum, ob.gyn. consultations present unique opportunities to increase patient engagement in healthy behaviors, such as diet, exercise, and regular sleep, because women are highly motivated to do what is best for their babies.

Immunization during pregnancy not only reduces the mother’s risk of severe disease, which can lead to complications, defects, and fetal or perinatal death, but also has been shown to improve the neonate’s ability to fight infection and may reduce vertical transmission of certain diseases. In this era of COVID-19 where we have no vaccine but we have evidence that pregnant women may be at greater risk for severe disease,⁵ routine immunizations are vital to maternal and fetal health.

We have invited Laura E. Riley, MD, chair of obstetrics and gynecology at Weill Cornell Medicine, New York, to address the importance of vaccination and the role of the ob.gyn. in advocating for this life-saving preventive health measure. Dr. Riley disclosed she is an author for Up to Date and was a consultant to GlaxoSmithKline about a cytomegalovirus vaccine. 

Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, Baltimore County, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at [email protected].

References

1. MMWR Morb Mortal Wkly Rep. 1999 Apr 2;48(12);243-8.

2. JAMA. 2007 Nov 14;298(18):2155-63.

3. MMWR Morb Mortal Wkly Rep. 2017 May 5;66(11);1-28.

4. CDC National Center for Health Statistics FastStats on Immunization.

5. MMWR Morb Mortal Wkly Rep. 2020 Jun 26;69(25);769-75.

Maternal immunization remains a priority for ob.gyns. – an opportunity to provide protection against serious infectious diseases for both the mother and the baby. With influenza vaccination rates in pregnant women still hovering around 50% and the emerging public health problem of vaccine hesitancy, we must fully embrace our responsibility to recommend immunizations and to effectively communicate what is known about their efficacy and safety. Ideally, we should offer them as well.

One reason for the low rates of influenza vaccination – one of the two vaccinations routinely recommended for all pregnant women in the United States – is that pregnant women do not always know the importance of the vaccine. This is actionable: Data clearly show that the physician’s recommendation makes a difference and that a clinician’s offer to administer the vaccination has an even greater impact.

A 2017 Centers for Disease Control and Prevention analysis of data from Internet panel surveys¹ shows that women who reported receiving both a clinician recommendation and offer of vaccination had higher coverage during the 2015-2016 and 2016-2017 influenza seasons (63.7% and 70.5%) than did women who reported receiving a clinician recommendation but no offer (37.5% and 43.7%) and women who reported receiving no recommendation for vaccination (12.8% and 14.8%).

The analysis suggests there are consistently missed opportunities: Fewer than 70% (67.3%) of pregnant women in the 2016-2017 flu season reported receiving a clinician recommendation for and offer of vaccination. This is similar to the prior three flu seasons, according to the CDC.

This year, with the COVID-19 pandemic ensuing, the prevention of severe influenza illness – and other vaccine-preventable illnesses – takes on even greater importance. It is not known what the impact of two potentially devastating respiratory infections could be for pregnant individuals. Therefore, maximal protection against at least influenza will be critical.
 

Influenza and Tdap

Poor outcomes and disproportionately high death rates for pregnant women were observed in both the influenza pandemic of 1918-1919 and the 1957 “Asian flu” pandemic. Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), but it was the H1N1 influenza pandemic of 2009 that reinforced its value and led our field to more fully embrace influenza vaccination as a priority for prenatal care.

Surprisingly, most of the pregnant women who became severely ill from the H1N1 virus were young and healthy and did not have a coexisting condition known to increase risk, such as asthma or diabetes. In an analysis of California epidemiologic data, ² only one-third of 94 pregnant women who were hospitalized with 2009 H1N1 influenza had established risk factors for complications from influenza, compared with almost two-thirds of nonpregnant women of reproductive age.

Nationally, 75 deaths of pregnant women were confirmed as because of H1N1 and 34 were possibly related to H1N1, most of which (64.3%) occurred in the third trimester.³ Records of the 1957 pandemic similarly show that pregnant women in the second and third trimesters were particularly affected.

That healthy pregnant women became so ill during the H1N1 pandemic raised several flags. For one, it became clearer that pregnancy is its own significant risk factor for severe illness from the influenza virus. Physiological changes believed to make a pregnant woman more susceptible to becoming ill include decreased lung capacity, increased nasal congestion, reduced colloid oncotic pressure, and changes in the immune system. The morbidity and mortality from H1N1 influenza also increased our drive as a specialty to convince women that vaccination is an important strategy in each influenza season.

The flu vaccine can be administered at any point during pregnancy. There is no evidence that the safety profile is any different during one trimester than another.

Patients should be reassured that vaccines recommended in pregnancy have undergone rigorous testing and that the influenza vaccine has been given to millions of pregnant women over decades. They also should understand that contracting influenza has risks for the fetus; research has demonstrated that pregnant women who contract influenza are at greater risk of spontaneous abortion as well as preterm birth and low birth weight.⁴

In addition, the issue of flu vaccine efficacy needs to be properly teased apart. Women read every year that the vaccine is not effective, so we need to discuss with patients what efficacy means. Does the vaccine prevent illness altogether, or does it prevent severe illness? For the most part, whereas influenza vaccines often do not offer an exact match for the year’s circulating strains – and therefore may not prevent all illness – data show that the vaccine can prevent severe illness.⁵ That is a worthy outcome.

Also worthy is the impact of influenza vaccination on the newborn. That maternal immunization also protects the baby – it can reduce the risk for influenza in infants under 6 months of age – is underappreciated and should be part of patient counseling. There is clear evidence that maternal immunization boosts the concentration of maternal antibodies that can cross the placenta and that infants benefit from this passive antibody protection.⁶

The Tdap vaccine (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis), the second vaccine routinely recommended during each pregnancy, is administered as early as possible during the third trimester precisely for this reason – to boost maternal immune response and maximize the passive transfer of antibodies to the newborn. The target is the prevention of pertussis and associated hospitalizations and death during the first 2 months of life in an era when sporadic and unpredictable outbreaks of the infection are occurring.

Data from the CDC of morbidity and mortality from pertussis in children (2001-2011) prior to routine maternal vaccination show that the highest rates of pediatric hospitalizations and deaths occurred in newborns. Research has demonstrated that the Tdap vaccine is highly effective in preventing infections and hospitalizations in newborns: Case-control and cohort studies in the United Kingdom^7,8 have shown vaccine effectiveness of 91%-93%, and similar research⁹ done in the U.S. has demonstrated effectiveness of 78%-85%.

The Tdap vaccine is recommended for pregnant women at 27-36 weeks of gestation – in each pregnancy. The reason for revaccination with each pregnancy is that antibody levels do not remain high for too long; at 8 months post immunization, research has shown, maternal antibody levels have begun to wane.

The vaccine also is recommended for all individuals who will be in close contact with infants younger than 12 months (for example, parents, grandparents, and child-care providers) and who have not previously received it. However, “cocooning” the newborn is effective only when the mother also is immunized – a point that ob.gyns. need to better explain to their patients so that they understand the purpose of this strategy.
 

Other vaccines in pregnancy and post partum

As described in the American College of Obstetricians and Gynecologists’ committee opinion on maternal immunization, ⁴ it is the responsibility of the ob.gyn. or obstetric care provider to routinely assess the immunization status of every pregnant patient and recommend additional vaccines for those patients who have conditions or social/behavioral practices that put them at higher risk of acquiring vaccine-preventable diseases.

Patients who have asthma or diabetes, who smoke, or who have never been vaccinated for the prevention of pneumococcal disease should receive the PPV23 pneumococcal vaccine, for instance. For pregnant women with immune deficiencies such as HIV, the PCV13 vaccine followed by PPV23 is recommended. There are approximately 500,000 cases of invasive pneumococcal disease in the United States each year, resulting in 40,000 deaths, and many multidrug-resistant strains of Streptococcus pneumoniae.

Hepatitis A and B vaccines – both recombinant vaccines with no safety concerns – also can be given during pregnancy and are officially recommended for women who have high-risk exposures. In the case of hepatitis A, high risk entails traveling to countries where the disease is endemic. High-risk behavior for hepatitis B includes sex work or being the household contact or sexual partner of a person positive for hepatitis B surface antigen.

Other travel-related vaccines, such as Japanese encephalitis, yellow fever, smallpox, and inactivated polio vaccine, can be considered in pregnancy, but decisions should be driven by more in-depth conversations about potential risks and benefits. Unlike for other vaccinations, there are limited data on the safety of travel-related immunizations in pregnancy. Sometimes, the question of whether travel is advisable in the middle of pregnancy – whether potential risks are worth taking – is a valid question to pose in conversations with patients.

Standard obstetric practice includes assessment of rubella susceptibility at the beginning of pregnancy. In some locations such as New York, measles susceptibility is also routinely evaluated. After delivery, seronegative women should be vaccinated with MMR (measles, mumps, and rubella) vaccine prior to discharge. In recent years, with the growing problem of vaccine refusal and an increasingly mobile and global society, we’re seeing sporadic outbreaks of measles and rubella – diseases that were once eradicated.

Measles in particular is highly contagious and requires a herd immunity threshold of 92%-94% to prevent sustained spread of the disease. Postpartum immunization has important maternal and pediatric implications for subsequent pregnancies, before which vaccination is often missed.

Both the MMR vaccine and the varicella vaccine (another vaccine that can be initiated post partum) are live vaccines and therefore contraindicated during pregnancy but should be administered post partum, including to people who are breastfeeding.

Other immunizations that hold some promise to protect either the mother or fetus/neonate or both are in various stages of development or testing. These include vaccines for cytomegalovirus, malaria, respiratory syncytial virus, and group B streptococcus.
 

A word about COVID-19

In mid-July there were more than 120 vaccine candidates for COVID-19 in various phases of study and a host of questions. Will a vaccine be efficacious? Will it prevent severe illness, or illness altogether? And will it be safe for pregnant women?

Vaccines work by manipulating the immune system, and it is important to appreciate the possibility that there may be unique pregnancy-related issues to consider with future COVID-19 vaccines – issues that could influence the effectiveness, safety, and timing of vaccination – and to understand that with any new immunization, there will likely be reluctance on the part of pregnant women who routinely prioritize fetal safety over their own health.

Pregnant women have been excluded from COVID-19 vaccine trials, but there may come a time when experts decide that a vaccine against COVID-19 is beneficial in pregnancy. Thus far, we know that the disease is clearly different from influenza. A growing knowledge of the impact of COVID-19 on the health of pregnant women, particularly the risk of developing severe illness, will be important for the future of COVID-19 immunization, as many women will not want to accept any potential risk of a vaccine unless they believe there is a significant benefit.
 

References

1. MMWR Morb Mortal Wkly Rep. 2017 Sep 29;66(38):1016-22.

2. N Engl J Med. 2010 Jan 7;362(1):27-35.

3. Obstet Gynecol. 2015 Sep;126(3):486-90.

4. Obstet Gynecol. 2018 Jun;131(6):e214-e217.

5. MMWR Morb Mortal Wkly Rep. 2019 Feb 15;68(6):135-9.

6. Obstet Gynecol. 2019 Apr;133(4):739-53.

7. Lancet. 2014 Oct 25;384(9953):1521-8.

8. Clin Infect Dis. 2015 Feb 1;60(3):333-7.

9. Clin Infect Dis. 2017 Jan 1;64(1):9-14.

Maternal immunization remains a priority for ob.gyns. – an opportunity to provide protection against serious infectious diseases for both the mother and the baby. With influenza vaccination rates in pregnant women still hovering around 50% and the emerging public health problem of vaccine hesitancy, we must fully embrace our responsibility to recommend immunizations and to effectively communicate what is known about their efficacy and safety. Ideally, we should offer them as well.

One reason for the low rates of influenza vaccination – one of the two vaccinations routinely recommended for all pregnant women in the United States – is that pregnant women do not always know the importance of the vaccine. This is actionable: Data clearly show that the physician’s recommendation makes a difference and that a clinician’s offer to administer the vaccination has an even greater impact.

A 2017 Centers for Disease Control and Prevention analysis of data from Internet panel surveys¹ shows that women who reported receiving both a clinician recommendation and offer of vaccination had higher coverage during the 2015-2016 and 2016-2017 influenza seasons (63.7% and 70.5%) than did women who reported receiving a clinician recommendation but no offer (37.5% and 43.7%) and women who reported receiving no recommendation for vaccination (12.8% and 14.8%).

The analysis suggests there are consistently missed opportunities: Fewer than 70% (67.3%) of pregnant women in the 2016-2017 flu season reported receiving a clinician recommendation for and offer of vaccination. This is similar to the prior three flu seasons, according to the CDC.

This year, with the COVID-19 pandemic ensuing, the prevention of severe influenza illness – and other vaccine-preventable illnesses – takes on even greater importance. It is not known what the impact of two potentially devastating respiratory infections could be for pregnant individuals. Therefore, maximal protection against at least influenza will be critical.
 

Influenza and Tdap

Poor outcomes and disproportionately high death rates for pregnant women were observed in both the influenza pandemic of 1918-1919 and the 1957 “Asian flu” pandemic. Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), but it was the H1N1 influenza pandemic of 2009 that reinforced its value and led our field to more fully embrace influenza vaccination as a priority for prenatal care.

Surprisingly, most of the pregnant women who became severely ill from the H1N1 virus were young and healthy and did not have a coexisting condition known to increase risk, such as asthma or diabetes. In an analysis of California epidemiologic data, ² only one-third of 94 pregnant women who were hospitalized with 2009 H1N1 influenza had established risk factors for complications from influenza, compared with almost two-thirds of nonpregnant women of reproductive age.

Nationally, 75 deaths of pregnant women were confirmed as because of H1N1 and 34 were possibly related to H1N1, most of which (64.3%) occurred in the third trimester.³ Records of the 1957 pandemic similarly show that pregnant women in the second and third trimesters were particularly affected.

That healthy pregnant women became so ill during the H1N1 pandemic raised several flags. For one, it became clearer that pregnancy is its own significant risk factor for severe illness from the influenza virus. Physiological changes believed to make a pregnant woman more susceptible to becoming ill include decreased lung capacity, increased nasal congestion, reduced colloid oncotic pressure, and changes in the immune system. The morbidity and mortality from H1N1 influenza also increased our drive as a specialty to convince women that vaccination is an important strategy in each influenza season.

The flu vaccine can be administered at any point during pregnancy. There is no evidence that the safety profile is any different during one trimester than another.

Patients should be reassured that vaccines recommended in pregnancy have undergone rigorous testing and that the influenza vaccine has been given to millions of pregnant women over decades. They also should understand that contracting influenza has risks for the fetus; research has demonstrated that pregnant women who contract influenza are at greater risk of spontaneous abortion as well as preterm birth and low birth weight.⁴

In addition, the issue of flu vaccine efficacy needs to be properly teased apart. Women read every year that the vaccine is not effective, so we need to discuss with patients what efficacy means. Does the vaccine prevent illness altogether, or does it prevent severe illness? For the most part, whereas influenza vaccines often do not offer an exact match for the year’s circulating strains – and therefore may not prevent all illness – data show that the vaccine can prevent severe illness.⁵ That is a worthy outcome.

Also worthy is the impact of influenza vaccination on the newborn. That maternal immunization also protects the baby – it can reduce the risk for influenza in infants under 6 months of age – is underappreciated and should be part of patient counseling. There is clear evidence that maternal immunization boosts the concentration of maternal antibodies that can cross the placenta and that infants benefit from this passive antibody protection.⁶

The Tdap vaccine (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis), the second vaccine routinely recommended during each pregnancy, is administered as early as possible during the third trimester precisely for this reason – to boost maternal immune response and maximize the passive transfer of antibodies to the newborn. The target is the prevention of pertussis and associated hospitalizations and death during the first 2 months of life in an era when sporadic and unpredictable outbreaks of the infection are occurring.

Data from the CDC of morbidity and mortality from pertussis in children (2001-2011) prior to routine maternal vaccination show that the highest rates of pediatric hospitalizations and deaths occurred in newborns. Research has demonstrated that the Tdap vaccine is highly effective in preventing infections and hospitalizations in newborns: Case-control and cohort studies in the United Kingdom^7,8 have shown vaccine effectiveness of 91%-93%, and similar research⁹ done in the U.S. has demonstrated effectiveness of 78%-85%.

The Tdap vaccine is recommended for pregnant women at 27-36 weeks of gestation – in each pregnancy. The reason for revaccination with each pregnancy is that antibody levels do not remain high for too long; at 8 months post immunization, research has shown, maternal antibody levels have begun to wane.

The vaccine also is recommended for all individuals who will be in close contact with infants younger than 12 months (for example, parents, grandparents, and child-care providers) and who have not previously received it. However, “cocooning” the newborn is effective only when the mother also is immunized – a point that ob.gyns. need to better explain to their patients so that they understand the purpose of this strategy.
 

Other vaccines in pregnancy and post partum

As described in the American College of Obstetricians and Gynecologists’ committee opinion on maternal immunization, ⁴ it is the responsibility of the ob.gyn. or obstetric care provider to routinely assess the immunization status of every pregnant patient and recommend additional vaccines for those patients who have conditions or social/behavioral practices that put them at higher risk of acquiring vaccine-preventable diseases.

Patients who have asthma or diabetes, who smoke, or who have never been vaccinated for the prevention of pneumococcal disease should receive the PPV23 pneumococcal vaccine, for instance. For pregnant women with immune deficiencies such as HIV, the PCV13 vaccine followed by PPV23 is recommended. There are approximately 500,000 cases of invasive pneumococcal disease in the United States each year, resulting in 40,000 deaths, and many multidrug-resistant strains of Streptococcus pneumoniae.

Hepatitis A and B vaccines – both recombinant vaccines with no safety concerns – also can be given during pregnancy and are officially recommended for women who have high-risk exposures. In the case of hepatitis A, high risk entails traveling to countries where the disease is endemic. High-risk behavior for hepatitis B includes sex work or being the household contact or sexual partner of a person positive for hepatitis B surface antigen.

Other travel-related vaccines, such as Japanese encephalitis, yellow fever, smallpox, and inactivated polio vaccine, can be considered in pregnancy, but decisions should be driven by more in-depth conversations about potential risks and benefits. Unlike for other vaccinations, there are limited data on the safety of travel-related immunizations in pregnancy. Sometimes, the question of whether travel is advisable in the middle of pregnancy – whether potential risks are worth taking – is a valid question to pose in conversations with patients.

Standard obstetric practice includes assessment of rubella susceptibility at the beginning of pregnancy. In some locations such as New York, measles susceptibility is also routinely evaluated. After delivery, seronegative women should be vaccinated with MMR (measles, mumps, and rubella) vaccine prior to discharge. In recent years, with the growing problem of vaccine refusal and an increasingly mobile and global society, we’re seeing sporadic outbreaks of measles and rubella – diseases that were once eradicated.

Measles in particular is highly contagious and requires a herd immunity threshold of 92%-94% to prevent sustained spread of the disease. Postpartum immunization has important maternal and pediatric implications for subsequent pregnancies, before which vaccination is often missed.

Both the MMR vaccine and the varicella vaccine (another vaccine that can be initiated post partum) are live vaccines and therefore contraindicated during pregnancy but should be administered post partum, including to people who are breastfeeding.

Other immunizations that hold some promise to protect either the mother or fetus/neonate or both are in various stages of development or testing. These include vaccines for cytomegalovirus, malaria, respiratory syncytial virus, and group B streptococcus.
 

A word about COVID-19

In mid-July there were more than 120 vaccine candidates for COVID-19 in various phases of study and a host of questions. Will a vaccine be efficacious? Will it prevent severe illness, or illness altogether? And will it be safe for pregnant women?

Vaccines work by manipulating the immune system, and it is important to appreciate the possibility that there may be unique pregnancy-related issues to consider with future COVID-19 vaccines – issues that could influence the effectiveness, safety, and timing of vaccination – and to understand that with any new immunization, there will likely be reluctance on the part of pregnant women who routinely prioritize fetal safety over their own health.

Pregnant women have been excluded from COVID-19 vaccine trials, but there may come a time when experts decide that a vaccine against COVID-19 is beneficial in pregnancy. Thus far, we know that the disease is clearly different from influenza. A growing knowledge of the impact of COVID-19 on the health of pregnant women, particularly the risk of developing severe illness, will be important for the future of COVID-19 immunization, as many women will not want to accept any potential risk of a vaccine unless they believe there is a significant benefit.
 

References

1. MMWR Morb Mortal Wkly Rep. 2017 Sep 29;66(38):1016-22.

2. N Engl J Med. 2010 Jan 7;362(1):27-35.

3. Obstet Gynecol. 2015 Sep;126(3):486-90.

4. Obstet Gynecol. 2018 Jun;131(6):e214-e217.

5. MMWR Morb Mortal Wkly Rep. 2019 Feb 15;68(6):135-9.

6. Obstet Gynecol. 2019 Apr;133(4):739-53.

7. Lancet. 2014 Oct 25;384(9953):1521-8.

8. Clin Infect Dis. 2015 Feb 1;60(3):333-7.

9. Clin Infect Dis. 2017 Jan 1;64(1):9-14.

Maternal immunization remains a priority for ob.gyns. – an opportunity to provide protection against serious infectious diseases for both the mother and the baby. With influenza vaccination rates in pregnant women still hovering around 50% and the emerging public health problem of vaccine hesitancy, we must fully embrace our responsibility to recommend immunizations and to effectively communicate what is known about their efficacy and safety. Ideally, we should offer them as well.

One reason for the low rates of influenza vaccination – one of the two vaccinations routinely recommended for all pregnant women in the United States – is that pregnant women do not always know the importance of the vaccine. This is actionable: Data clearly show that the physician’s recommendation makes a difference and that a clinician’s offer to administer the vaccination has an even greater impact.

A 2017 Centers for Disease Control and Prevention analysis of data from Internet panel surveys¹ shows that women who reported receiving both a clinician recommendation and offer of vaccination had higher coverage during the 2015-2016 and 2016-2017 influenza seasons (63.7% and 70.5%) than did women who reported receiving a clinician recommendation but no offer (37.5% and 43.7%) and women who reported receiving no recommendation for vaccination (12.8% and 14.8%).

The analysis suggests there are consistently missed opportunities: Fewer than 70% (67.3%) of pregnant women in the 2016-2017 flu season reported receiving a clinician recommendation for and offer of vaccination. This is similar to the prior three flu seasons, according to the CDC.

This year, with the COVID-19 pandemic ensuing, the prevention of severe influenza illness – and other vaccine-preventable illnesses – takes on even greater importance. It is not known what the impact of two potentially devastating respiratory infections could be for pregnant individuals. Therefore, maximal protection against at least influenza will be critical.
 

Influenza and Tdap

Poor outcomes and disproportionately high death rates for pregnant women were observed in both the influenza pandemic of 1918-1919 and the 1957 “Asian flu” pandemic. Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), but it was the H1N1 influenza pandemic of 2009 that reinforced its value and led our field to more fully embrace influenza vaccination as a priority for prenatal care.

Surprisingly, most of the pregnant women who became severely ill from the H1N1 virus were young and healthy and did not have a coexisting condition known to increase risk, such as asthma or diabetes. In an analysis of California epidemiologic data, ² only one-third of 94 pregnant women who were hospitalized with 2009 H1N1 influenza had established risk factors for complications from influenza, compared with almost two-thirds of nonpregnant women of reproductive age.

Nationally, 75 deaths of pregnant women were confirmed as because of H1N1 and 34 were possibly related to H1N1, most of which (64.3%) occurred in the third trimester.³ Records of the 1957 pandemic similarly show that pregnant women in the second and third trimesters were particularly affected.

That healthy pregnant women became so ill during the H1N1 pandemic raised several flags. For one, it became clearer that pregnancy is its own significant risk factor for severe illness from the influenza virus. Physiological changes believed to make a pregnant woman more susceptible to becoming ill include decreased lung capacity, increased nasal congestion, reduced colloid oncotic pressure, and changes in the immune system. The morbidity and mortality from H1N1 influenza also increased our drive as a specialty to convince women that vaccination is an important strategy in each influenza season.

The flu vaccine can be administered at any point during pregnancy. There is no evidence that the safety profile is any different during one trimester than another.

Patients should be reassured that vaccines recommended in pregnancy have undergone rigorous testing and that the influenza vaccine has been given to millions of pregnant women over decades. They also should understand that contracting influenza has risks for the fetus; research has demonstrated that pregnant women who contract influenza are at greater risk of spontaneous abortion as well as preterm birth and low birth weight.⁴

In addition, the issue of flu vaccine efficacy needs to be properly teased apart. Women read every year that the vaccine is not effective, so we need to discuss with patients what efficacy means. Does the vaccine prevent illness altogether, or does it prevent severe illness? For the most part, whereas influenza vaccines often do not offer an exact match for the year’s circulating strains – and therefore may not prevent all illness – data show that the vaccine can prevent severe illness.⁵ That is a worthy outcome.

Also worthy is the impact of influenza vaccination on the newborn. That maternal immunization also protects the baby – it can reduce the risk for influenza in infants under 6 months of age – is underappreciated and should be part of patient counseling. There is clear evidence that maternal immunization boosts the concentration of maternal antibodies that can cross the placenta and that infants benefit from this passive antibody protection.⁶

The Tdap vaccine (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis), the second vaccine routinely recommended during each pregnancy, is administered as early as possible during the third trimester precisely for this reason – to boost maternal immune response and maximize the passive transfer of antibodies to the newborn. The target is the prevention of pertussis and associated hospitalizations and death during the first 2 months of life in an era when sporadic and unpredictable outbreaks of the infection are occurring.

Data from the CDC of morbidity and mortality from pertussis in children (2001-2011) prior to routine maternal vaccination show that the highest rates of pediatric hospitalizations and deaths occurred in newborns. Research has demonstrated that the Tdap vaccine is highly effective in preventing infections and hospitalizations in newborns: Case-control and cohort studies in the United Kingdom^7,8 have shown vaccine effectiveness of 91%-93%, and similar research⁹ done in the U.S. has demonstrated effectiveness of 78%-85%.

The Tdap vaccine is recommended for pregnant women at 27-36 weeks of gestation – in each pregnancy. The reason for revaccination with each pregnancy is that antibody levels do not remain high for too long; at 8 months post immunization, research has shown, maternal antibody levels have begun to wane.

The vaccine also is recommended for all individuals who will be in close contact with infants younger than 12 months (for example, parents, grandparents, and child-care providers) and who have not previously received it. However, “cocooning” the newborn is effective only when the mother also is immunized – a point that ob.gyns. need to better explain to their patients so that they understand the purpose of this strategy.
 

Other vaccines in pregnancy and post partum

As described in the American College of Obstetricians and Gynecologists’ committee opinion on maternal immunization, ⁴ it is the responsibility of the ob.gyn. or obstetric care provider to routinely assess the immunization status of every pregnant patient and recommend additional vaccines for those patients who have conditions or social/behavioral practices that put them at higher risk of acquiring vaccine-preventable diseases.

Patients who have asthma or diabetes, who smoke, or who have never been vaccinated for the prevention of pneumococcal disease should receive the PPV23 pneumococcal vaccine, for instance. For pregnant women with immune deficiencies such as HIV, the PCV13 vaccine followed by PPV23 is recommended. There are approximately 500,000 cases of invasive pneumococcal disease in the United States each year, resulting in 40,000 deaths, and many multidrug-resistant strains of Streptococcus pneumoniae.

Hepatitis A and B vaccines – both recombinant vaccines with no safety concerns – also can be given during pregnancy and are officially recommended for women who have high-risk exposures. In the case of hepatitis A, high risk entails traveling to countries where the disease is endemic. High-risk behavior for hepatitis B includes sex work or being the household contact or sexual partner of a person positive for hepatitis B surface antigen.

Other travel-related vaccines, such as Japanese encephalitis, yellow fever, smallpox, and inactivated polio vaccine, can be considered in pregnancy, but decisions should be driven by more in-depth conversations about potential risks and benefits. Unlike for other vaccinations, there are limited data on the safety of travel-related immunizations in pregnancy. Sometimes, the question of whether travel is advisable in the middle of pregnancy – whether potential risks are worth taking – is a valid question to pose in conversations with patients.

Standard obstetric practice includes assessment of rubella susceptibility at the beginning of pregnancy. In some locations such as New York, measles susceptibility is also routinely evaluated. After delivery, seronegative women should be vaccinated with MMR (measles, mumps, and rubella) vaccine prior to discharge. In recent years, with the growing problem of vaccine refusal and an increasingly mobile and global society, we’re seeing sporadic outbreaks of measles and rubella – diseases that were once eradicated.

Measles in particular is highly contagious and requires a herd immunity threshold of 92%-94% to prevent sustained spread of the disease. Postpartum immunization has important maternal and pediatric implications for subsequent pregnancies, before which vaccination is often missed.

Both the MMR vaccine and the varicella vaccine (another vaccine that can be initiated post partum) are live vaccines and therefore contraindicated during pregnancy but should be administered post partum, including to people who are breastfeeding.

Other immunizations that hold some promise to protect either the mother or fetus/neonate or both are in various stages of development or testing. These include vaccines for cytomegalovirus, malaria, respiratory syncytial virus, and group B streptococcus.
 

A word about COVID-19

In mid-July there were more than 120 vaccine candidates for COVID-19 in various phases of study and a host of questions. Will a vaccine be efficacious? Will it prevent severe illness, or illness altogether? And will it be safe for pregnant women?

Vaccines work by manipulating the immune system, and it is important to appreciate the possibility that there may be unique pregnancy-related issues to consider with future COVID-19 vaccines – issues that could influence the effectiveness, safety, and timing of vaccination – and to understand that with any new immunization, there will likely be reluctance on the part of pregnant women who routinely prioritize fetal safety over their own health.

Pregnant women have been excluded from COVID-19 vaccine trials, but there may come a time when experts decide that a vaccine against COVID-19 is beneficial in pregnancy. Thus far, we know that the disease is clearly different from influenza. A growing knowledge of the impact of COVID-19 on the health of pregnant women, particularly the risk of developing severe illness, will be important for the future of COVID-19 immunization, as many women will not want to accept any potential risk of a vaccine unless they believe there is a significant benefit.
 

References

1. MMWR Morb Mortal Wkly Rep. 2017 Sep 29;66(38):1016-22.

2. N Engl J Med. 2010 Jan 7;362(1):27-35.

3. Obstet Gynecol. 2015 Sep;126(3):486-90.

4. Obstet Gynecol. 2018 Jun;131(6):e214-e217.

5. MMWR Morb Mortal Wkly Rep. 2019 Feb 15;68(6):135-9.

6. Obstet Gynecol. 2019 Apr;133(4):739-53.

7. Lancet. 2014 Oct 25;384(9953):1521-8.

8. Clin Infect Dis. 2015 Feb 1;60(3):333-7.

9. Clin Infect Dis. 2017 Jan 1;64(1):9-14.

The American Society for Metabolic & Bariatric Surgery (ASMBS) has issued a statement declaring that obesity surgery is not elective and should be resumed as soon as it›s safe to do so during the COVID-19 pandemic.

The ASMBS statement, “Safer Through Surgery,” was published online in Surgery for Obesity and Related Diseases by the ASMBS executive committee.

It is a reaction to the fact that some U.S. states have placed metabolic and bariatric surgery in the same low-priority category as cosmetic surgery as examples of “elective” procedures that should be among the last to be restarted when pandemic restrictions are eased.

Rather, ASMBS argues, although obesity surgery must be postponed along with other nonemergency procedures when surges in the novel coronavirus make them unsafe, such operations should be resumed as soon as possible along with other medically necessary procedures.

“Metabolic and bariatric surgery is NOT elective. Metabolic and bariatric surgery is medically necessary and the best treatment for those with the life-threatening and life-limiting disease of severe obesity,” the statement says.

And obesity itself is a major risk factor for worse COVID-19 outcomes, ASMBS President Matt Hutter, MD, told Medscape Medical News, noting that individuals with obesity are “more likely to be in [intensive care units].”

“Mortality rates are higher, even in young patients. And [obesity] ... is associated with other comorbidities including diabetes and heart disease...We know the clock is ticking for some folks. For those with early diabetes, the sooner the [bariatric] surgery the more likely it is [for diabetes] to go into remission.”

Because the pandemic may be around for a while, “If we can make people [with obesity] safer ... because they’ve had surgery ... they may be better off,” should they get COVID-19 later, he pointed out.

Hutter noted that the ASMBS recorded a series of webinars, archived on the society’s website, with panels discussing in-depth issues to consider in prioritizing patients when restarting metabolic and bariatric surgery.

There are some differences of opinion, such as whether the sickest patients should be the first to have the surgeries upon reopening, or whether those individuals might be worse off if they contract COVID-19 in the perioperative setting.

“I don’t think there’s a right or wrong answer, but I think we have to figure out what’s right for the individual patient, considering their specific risks of having versus not having surgery, of waiting 1 month, 2 months, or 6 months. One thing we do know is that obesity is a significant disease.”
 

‘Before, during, and after COVID, obesity itself remains an epidemic’

Asked to comment on the ASMBS stance, Obesity Society president Lee M. Kaplan, MD, PhD, sent Medscape Medical News a statement.

“We do not fully understand which aspects of obesity pathophysiology ... are most responsible for the adverse COVID-19 outcomes, nor do we know the degree to which reduced access to care, social isolation, and other social and environmental determinants of health disproportionately affect COVID-19 patients with obesity,” he noted.

“At this early stage, we have not yet determined the impact of weight loss and various types of antiobesity therapies on these risks.”

Nonetheless, Kaplan said, “the extended COVID-19 pandemic underscores the importance of increasing, not diminishing, our commitment to understanding and treating obesity, using all available, evidence-based therapies, including lifestyle modification, antiobesity medications, bariatric surgery, and combinations thereof.”

As all health care delivery is being reorganized around the pandemic, Kaplan added: “Rethinking and changing our approach to obesity needs to be a central feature of this process.

“Before, during, and after COVID, obesity itself remains an epidemic. Its high global prevalence, increasing severity, and profound impact on all aspects of health and disease require that it be addressed more universally within the health care system, with the same commitment afforded to other chronic diseases.”

Obesity treatment isn’t generally considered an emergency, he noted, “because obesity is a chronic disease, whose adverse health effects often accumulate slowly and insidiously. Its generally slow progression allows for careful and coordinated care planning, and advanced scheduling of therapeutic interventions, including surgery. These characteristics, however, should not lead us to infer that treating obesity itself is optional.”

Hutter has reported receiving honoraria from Ethicon and Medtronic, and is a consultant for Vicarious Surgical and Sigilon Therapeutics. Kaplan has reported consulting for Boehringer Ingelheim, Fractyl, Gelesis, GI Dynamics, Johnson & Johnson, Novo Nordisk, Pfizer, Rhythm Pharmaceuticals, the National Institutes of Health, and the Department of State.

The AGA Practice guide on Obesity and Weight management, Education and Resources (POWER) white paper provides physicians with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management. Learn more at www.gastro.org/obesity. 

This article first appeared on Medscape.com.

The American Society for Metabolic & Bariatric Surgery (ASMBS) has issued a statement declaring that obesity surgery is not elective and should be resumed as soon as it›s safe to do so during the COVID-19 pandemic.

The ASMBS statement, “Safer Through Surgery,” was published online in Surgery for Obesity and Related Diseases by the ASMBS executive committee.

It is a reaction to the fact that some U.S. states have placed metabolic and bariatric surgery in the same low-priority category as cosmetic surgery as examples of “elective” procedures that should be among the last to be restarted when pandemic restrictions are eased.

Rather, ASMBS argues, although obesity surgery must be postponed along with other nonemergency procedures when surges in the novel coronavirus make them unsafe, such operations should be resumed as soon as possible along with other medically necessary procedures.

“Metabolic and bariatric surgery is NOT elective. Metabolic and bariatric surgery is medically necessary and the best treatment for those with the life-threatening and life-limiting disease of severe obesity,” the statement says.

And obesity itself is a major risk factor for worse COVID-19 outcomes, ASMBS President Matt Hutter, MD, told Medscape Medical News, noting that individuals with obesity are “more likely to be in [intensive care units].”

“Mortality rates are higher, even in young patients. And [obesity] ... is associated with other comorbidities including diabetes and heart disease...We know the clock is ticking for some folks. For those with early diabetes, the sooner the [bariatric] surgery the more likely it is [for diabetes] to go into remission.”

Because the pandemic may be around for a while, “If we can make people [with obesity] safer ... because they’ve had surgery ... they may be better off,” should they get COVID-19 later, he pointed out.

Hutter noted that the ASMBS recorded a series of webinars, archived on the society’s website, with panels discussing in-depth issues to consider in prioritizing patients when restarting metabolic and bariatric surgery.

There are some differences of opinion, such as whether the sickest patients should be the first to have the surgeries upon reopening, or whether those individuals might be worse off if they contract COVID-19 in the perioperative setting.

“I don’t think there’s a right or wrong answer, but I think we have to figure out what’s right for the individual patient, considering their specific risks of having versus not having surgery, of waiting 1 month, 2 months, or 6 months. One thing we do know is that obesity is a significant disease.”
 

‘Before, during, and after COVID, obesity itself remains an epidemic’

Asked to comment on the ASMBS stance, Obesity Society president Lee M. Kaplan, MD, PhD, sent Medscape Medical News a statement.

“We do not fully understand which aspects of obesity pathophysiology ... are most responsible for the adverse COVID-19 outcomes, nor do we know the degree to which reduced access to care, social isolation, and other social and environmental determinants of health disproportionately affect COVID-19 patients with obesity,” he noted.

“At this early stage, we have not yet determined the impact of weight loss and various types of antiobesity therapies on these risks.”

Nonetheless, Kaplan said, “the extended COVID-19 pandemic underscores the importance of increasing, not diminishing, our commitment to understanding and treating obesity, using all available, evidence-based therapies, including lifestyle modification, antiobesity medications, bariatric surgery, and combinations thereof.”

As all health care delivery is being reorganized around the pandemic, Kaplan added: “Rethinking and changing our approach to obesity needs to be a central feature of this process.

“Before, during, and after COVID, obesity itself remains an epidemic. Its high global prevalence, increasing severity, and profound impact on all aspects of health and disease require that it be addressed more universally within the health care system, with the same commitment afforded to other chronic diseases.”

Obesity treatment isn’t generally considered an emergency, he noted, “because obesity is a chronic disease, whose adverse health effects often accumulate slowly and insidiously. Its generally slow progression allows for careful and coordinated care planning, and advanced scheduling of therapeutic interventions, including surgery. These characteristics, however, should not lead us to infer that treating obesity itself is optional.”

Hutter has reported receiving honoraria from Ethicon and Medtronic, and is a consultant for Vicarious Surgical and Sigilon Therapeutics. Kaplan has reported consulting for Boehringer Ingelheim, Fractyl, Gelesis, GI Dynamics, Johnson & Johnson, Novo Nordisk, Pfizer, Rhythm Pharmaceuticals, the National Institutes of Health, and the Department of State.

The AGA Practice guide on Obesity and Weight management, Education and Resources (POWER) white paper provides physicians with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management. Learn more at www.gastro.org/obesity. 

This article first appeared on Medscape.com.

The American Society for Metabolic & Bariatric Surgery (ASMBS) has issued a statement declaring that obesity surgery is not elective and should be resumed as soon as it›s safe to do so during the COVID-19 pandemic.

The ASMBS statement, “Safer Through Surgery,” was published online in Surgery for Obesity and Related Diseases by the ASMBS executive committee.

It is a reaction to the fact that some U.S. states have placed metabolic and bariatric surgery in the same low-priority category as cosmetic surgery as examples of “elective” procedures that should be among the last to be restarted when pandemic restrictions are eased.

Rather, ASMBS argues, although obesity surgery must be postponed along with other nonemergency procedures when surges in the novel coronavirus make them unsafe, such operations should be resumed as soon as possible along with other medically necessary procedures.

“Metabolic and bariatric surgery is NOT elective. Metabolic and bariatric surgery is medically necessary and the best treatment for those with the life-threatening and life-limiting disease of severe obesity,” the statement says.

And obesity itself is a major risk factor for worse COVID-19 outcomes, ASMBS President Matt Hutter, MD, told Medscape Medical News, noting that individuals with obesity are “more likely to be in [intensive care units].”

“Mortality rates are higher, even in young patients. And [obesity] ... is associated with other comorbidities including diabetes and heart disease...We know the clock is ticking for some folks. For those with early diabetes, the sooner the [bariatric] surgery the more likely it is [for diabetes] to go into remission.”

Because the pandemic may be around for a while, “If we can make people [with obesity] safer ... because they’ve had surgery ... they may be better off,” should they get COVID-19 later, he pointed out.

Hutter noted that the ASMBS recorded a series of webinars, archived on the society’s website, with panels discussing in-depth issues to consider in prioritizing patients when restarting metabolic and bariatric surgery.

There are some differences of opinion, such as whether the sickest patients should be the first to have the surgeries upon reopening, or whether those individuals might be worse off if they contract COVID-19 in the perioperative setting.

“I don’t think there’s a right or wrong answer, but I think we have to figure out what’s right for the individual patient, considering their specific risks of having versus not having surgery, of waiting 1 month, 2 months, or 6 months. One thing we do know is that obesity is a significant disease.”
 

‘Before, during, and after COVID, obesity itself remains an epidemic’

Asked to comment on the ASMBS stance, Obesity Society president Lee M. Kaplan, MD, PhD, sent Medscape Medical News a statement.

“We do not fully understand which aspects of obesity pathophysiology ... are most responsible for the adverse COVID-19 outcomes, nor do we know the degree to which reduced access to care, social isolation, and other social and environmental determinants of health disproportionately affect COVID-19 patients with obesity,” he noted.

“At this early stage, we have not yet determined the impact of weight loss and various types of antiobesity therapies on these risks.”

Nonetheless, Kaplan said, “the extended COVID-19 pandemic underscores the importance of increasing, not diminishing, our commitment to understanding and treating obesity, using all available, evidence-based therapies, including lifestyle modification, antiobesity medications, bariatric surgery, and combinations thereof.”

As all health care delivery is being reorganized around the pandemic, Kaplan added: “Rethinking and changing our approach to obesity needs to be a central feature of this process.

“Before, during, and after COVID, obesity itself remains an epidemic. Its high global prevalence, increasing severity, and profound impact on all aspects of health and disease require that it be addressed more universally within the health care system, with the same commitment afforded to other chronic diseases.”

Obesity treatment isn’t generally considered an emergency, he noted, “because obesity is a chronic disease, whose adverse health effects often accumulate slowly and insidiously. Its generally slow progression allows for careful and coordinated care planning, and advanced scheduling of therapeutic interventions, including surgery. These characteristics, however, should not lead us to infer that treating obesity itself is optional.”

Hutter has reported receiving honoraria from Ethicon and Medtronic, and is a consultant for Vicarious Surgical and Sigilon Therapeutics. Kaplan has reported consulting for Boehringer Ingelheim, Fractyl, Gelesis, GI Dynamics, Johnson & Johnson, Novo Nordisk, Pfizer, Rhythm Pharmaceuticals, the National Institutes of Health, and the Department of State.

The AGA Practice guide on Obesity and Weight management, Education and Resources (POWER) white paper provides physicians with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management. Learn more at www.gastro.org/obesity. 

This article first appeared on Medscape.com.